main_id,nct_id,drks_id,ictrp_id,created_at,des_q,des_a,des_c,inc_q,inc_a,inc_a_errtype,inc_c,int_q,int_a,int_c,pri_q,pri_a,pri_c,sec_q,sec_a,sec_c,samp_register,samp_artikel,samp_q,bli_q,bli_a_old,bli_a,bli_c,bli_register,bli_article,bli_errortype,tit_q,tit_c,link_desc,url,article_earliest_date,study_first_posted_date.aact,results_first_posted_date.aact,start_date.aact,completion_date.aact,study_type.aact,title.aact,official_title.aact,overall_status.aact,phase.aact,n.aact,enrollment_type.aact,source.aact,prim_outcome.aact,sec_outcome.aact,sec_id_ictrp,title.ictrp,official_title.ictrp,email_scientific.ictrp,email_public.ictrp,study_type.ictrp,study_design.ictrp,phase.ictrp,created_at.ictrp,start_date.ictrp,n.ictrp,overall_status.ictrp,name.ictrp,secondary_sponsors.ictrp,countries.ictrp,interventions.ictrp,inclusion_criteria.ictrp,exclusion_criteria.ictrp,prim_outcome.ictrp,sec_outcome.ictrp,sec_id_drks,created_at.drks,investorInitiated.drks,indication.drks,intervention.drks,study_type.drks,allocation.drks,masking.drks,control.drks,assignment.drks,phase.drks,prim_outcome.drks,sec_outcome.drks,countries.drks,recruit_locations.drks,start_date.drks,plannedActual.drks,n.drks,studyEnd.drks,inclusion.drks,exclusion.drks,official_title.drks,recruitmentStatus.drks,name.drks,email_central.drks,publications.drks,summarized_start_date,study_first_submitted_date.aact,summarized_first_posted,summarized_n,summarized_study_type,is_exz,is_koor,pre_nct,pre_drks,pre_ictrp,summarized_pre,has_univ_aact,has_univ_ictrp,has_univ_drks,has_univ,start_year,last_update_submitted_date,has_nct,has_drks,has_euctr
95,NCT04053192,NA,NA,NCT: 2019-08-07 ICTRP: NA DRKS: NA,1,1,NA,1,1,r,NA,NA,NA,NA,4,1,no AM,4,1,NA,NCT: Anticipated 100 ICTRP: NA DRKS: NA,156,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1002/ccd.28950,2020-04-22,2019-08-12,NA,2018-06-01,2019-08-31,Observational,Evaluation of BAV in Different Hemodynamic Entities of Severe AS,Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis,Completed,NA,166,Actual,"Heinrich-Heine University, Duesseldorf",All-cause Mortality;Post-Procedure Hemodynamic Changes,Number of patients with myocardial infarction;Number of patients with stroke;Number of patients with bleeding complications;Number of patients with acute kidney injury;Number of patients with vascular complications,19-003 BAV,Evaluation of BAV in Different Hemodynamic Entities of Severe AS,Contemporary Use of Percutaneous Balloon Aortic Valvuloplasty and Evaluation of Its Success in Different Hemodynamic Entities of Severe Aortic Valve Stenosis,,,Observational,,,2019-08-07,2018-06-01,166,Completed,"Heinrich-Heine University, Duesseldorf",NULL,germany,Procedure: BAV;Procedure: BAV + TAVR;Procedure: SAVR,
Inclusion Criteria:
- Patients with Severe Aortic Stenosos who underwent BAV
Exclusion Criteria:
- insufficient echocardiographic parameters before BAV
,NULL,All-cause Mortality;Post-Procedure Hemodynamic Changes,Number of patients with myocardial infarction;Number of patients with stroke;Number of patients with bleeding complications;Number of patients with acute kidney injury;Number of patients with vascular complications,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-06-01,2019-08-07,2019-08-07,166,Observational,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2018,2019-12-19,TRUE,FALSE,FALSE
142,NCT04024579,NA,NCT04024579,NCT: 2019-07-16 ICTRP: 2019-07-16 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no metric",NA,NA,NA,NCT: Actual 73 ICTRP: 68 DRKS: NA,73,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2019-07-18,NA,2017-10-17,2019-08-25,Observational,Treatment of Actinic Keratosis With 5% KOH Solution,"Prospective, Single-arm, Medical Device Investigation According to § 23b MPG [German Medical Devices Act] on Efficacy and Safety of Treatment of Actinic Keratosis With a 5% Potassium Hydroxide Solution (AKOHDerm)",Completed,NA,73,Actual,Infectopharm Arzneimittel GmbH,Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator,,TAKKOH,Treatment of Actinic Keratosis With 5% KOH Solution,"Prospective, Single-arm, Medical Device Investigation According to § 23b MPG [German Medical Devices Act] on Efficacy and Safety of Treatment of Actinic Keratosis With a 5% Potassium Hydroxide Solution (AKOHDerm)",,,Observational,,,2019-07-16,2017-10-17,73,Completed,Infectopharm Arzneimittel GmbH,Gesellschaft für Therapieforschung mbH,germany,NULL,"
Inclusion Criteria:
- Written informed consent
- Age: 30 to 80 years
- Adults with AK grade I (mild) or II (moderate)
Exclusion Criteria:
- Number of lesions requiring treatment > 10
- Lesion to be treated > 20 mm (maximum diameter)
- Lesions directly adjoining to the eyes, eyelids, nostrils, mouth or mucosal tissue,
- Need for topical treatment of a cancerous area
- Presence of a relapsing, persistent, indurated, thickened, painful, bleeding,
ulcerated and/or rapidly growing lesion
- Presence of a persistent or relapsing lesion despite appropriate treatment with
AKOHDerm or another appropriate treatment
- High risk of progression of AK according as assessed by a medical doctor
- Pharmacological or physical local therapy of AK in the area foreseen for treatment
dur-ing the last 12 weeks
- Treatment with systemic corticosteroids during the last 2 weeks
- Planned concomitant treatment of the same AK lesions during the study in addition to
study treatment
- Other skin diseases in the area of application which might interfere with clinical
signs
- Known predisposition for hypertrophic scarring / keloidosis
- Primary or secondary immunodeficiency
- Treatment with interferons, interferon inducers or immunomodulators during the last 4
weeks
- Pregnancy and lactation
- No reliable contraception in women of child-bearing potential
- Other serious diseases which are according to the investigator in conflict with the
par-ticipation
- Obvious unreliability or lack of cooperation - known addiction to alcohol, medicinal
products or drugs
- Dependent relationship with sponsor or investigator
- Participation in a clinical trial within the last 30 days
- Previous participation in this study
",NULL,Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-10-17,2019-07-16,2019-07-16,73,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2017,2019-10-21,TRUE,FALSE,FALSE
374,NCT03900000,NA,NCT03900000,NCT: 2018-12-28 ICTRP: 2018-12-28 DRKS: NA,1,NA,NA,1,NA,NA,Which criteria?,2,NA,NA,3,NA,"no AM, no metric. Why cutpoint of <10mmHg?",3,NA,"no AM, no metric: Change in relation to what other measurement?",NCT: Actual 30 ICTRP: 30 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,"no intervention, different primary outcome",kein Artikel,NA,NA,2019-04-02,NA,2014-05-31,2018-10-31,Interventional,Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease,Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease: Does a Successful Treatment of Orthostatic Hypotension Measurably Enhance Attention and Memory Functions in Parkinson's Disease,Completed,N/A,30,Actual,RWTH Aachen University,Blood Pressure in mmHg,Attention in TAP;Orthostatic symptoms (Winkler Scale);daytime sleepiness,13-131,Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease,Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease: Does a Successful Treatment of Orthostatic Hypotension Measurably Enhance Attention and Memory Functions in Parkinson's Disease,,,Interventional,Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator). ,N/A,2018-12-28,2014-05-20,30,Completed,RWTH Aachen University,NULL,germany,Other: Physiotherapy,
Inclusion Criteria:
- Parkinson's patients
- Diagnostis of OH
- able to perform an ambulatory physiotherapy at Aachen University Hospital.
Exclusion Criteria:
- deep brain stimulation or Pacemaker
- severe psychiatric disease
- severe heart disease
- severe vascular encephalopathy
- dementia
- pregnant or lactating women
- extreme pain or immobility
,NULL,Blood Pressure in mmHg,Attention in TAP;Orthostatic symptoms (Winkler Scale);daytime sleepiness,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-05-31,2018-12-28,2018-12-28,30,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2014,2019-04-05,TRUE,FALSE,FALSE
670,NCT03767192,NA,NCT03767192,NCT: 2018-12-05 ICTRP: 2018-12-05 DRKS: NA,1,1,NA,2,1,r,NA,1,1,NA,5,1,NA,3,1,NA,NCT: Actual 327 ICTRP: 327 DRKS: NA,327,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",double,worse,1,NA,ganzer Artikel,https://doi.org/10.1161/strokeaha.118.024582,2018-12-10,2018-12-06,NA,2009-01-31,2012-03-31,Interventional,"Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)","A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke",Terminated,N/A,327,Actual,BrainsGate,Sliding Dichotomy modified Rankin Scale (mRS) at 3 months;Number of participants with Serious Adverse Events;Number of participants with neurological deterioration;Number of participants with implantation complications;Number of participants with stimulation-related adverse events;Mortality rate,Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline;Binary NIHSS at Day 90;Stroke-related quality of life at 3 months: Stroke Impact Scale-16,CLP1000500-24A,"Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)","A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",N/A,2018-12-05,2009-01-20,327,Terminated,BrainsGate,NULL,united states;germany;spain;germany;spain;united states,Device: Active Stimulation;Device: Sham Stimulation,"
Inclusion Criteria:
1. Age: = 18 years and = 85 of both genders.
2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior
Cerebral Artery territories
3. Baseline NIHSS = 7 and = 18
4. Ability to initiate treatment within 8- 24 hours from stroke onset.
Exclusion Criteria:
1. Intracranial hemorrhage or hemorrhagic transformation
2. Massive stroke
3. Acute ischemic stroke in the posterior circulation
4. Minor stroke
5. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
6. Previous stroke in the last 6 months or pre-existing disability
7. Patients with bleeding propensity or any condition in the oral cavity that prevents
implantation
8. Known cerebral arteriovenous malformation, cerebral aneurysm.
9. Clinical suspicion of septic embolus.
10. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
11. Serious systemic infection.
12. Women known to be pregnant or having a positive or indeterminate pregnancy test.
13. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
14. Life expectancy < 1 year from causes other than stroke.
",NULL,Sliding Dichotomy modified Rankin Scale (mRS) at 3 months;Number of participants with Serious Adverse Events;Number of participants with neurological deterioration;Number of participants with implantation complications;Number of participants with stimulation-related adverse events;Mortality rate,Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline;Binary NIHSS at Day 90;Stroke-related quality of life at 3 months: Stroke Impact Scale-16,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-01-31,2018-12-05,2018-12-05,327,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2009,2019-01-25,TRUE,FALSE,FALSE
808,NCT03710694,NA,NCT03710694,NCT: 2018-10-09 ICTRP: 2018-10-09 DRKS: NA,1,NA,NA,1,NA,NA,no info on measurement or criteria of infection and neutropenia,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 260 ICTRP: 260 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-10-18,NA,2018-10-31,2019-08-09,Interventional,Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI),"A European Multicenter, Randomized, Parallel-group Study to Evaluate the Safety and Efficacy/Performance of DAV132 in Hospitalized Patients at High Risk for Clostridium Difficile Infection and Who Receive Fluoroquinolones for the Treatment of Acute Infections",Completed,N/A,260,Actual,Da Volterra,Safety endpoint: Proportion of patients having at least one adverse event (AE) related to DAV132 and/or to fluoroquinolones (FQs) and which relationship to product (DAV132 or FQ) is confirmed by the Independent Adjudication Committee (IAC).,"Safety endpoint: Number of AEs and proportion of patients with at least one AE;Efficacy/performance endpoint, clinical:Proportion of patients with CDI;Efficacy/performance endpoint, clinical: Proportion of patients with AAD;Efficacy/performance endpoint, clinical: Plasma levels of FQs;Efficacy/performance endpoint, biological: Level of free fecal concentrations of FQs;Efficacy/performance endpoint, biological: Level of α-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Change from D1 of α-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Levels of β-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Proportion of patients with resistant bacteria and/or yeasts in feces;Efficacy/performance endpoint, biological: Proportion of patients with at least one occurrence of resistant bacteria and yeasts in feces (among patients negative at baseline);Efficacy/performance endpoint, biological: Proportion of patients with acquisition of intestinal colonization by C. difficile (among patients negative at baseline)",CIV-18-03-023465;DAV132-CL-2001,Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI),"A European Multicenter, Randomized, Parallel-group Study to Evaluate the Safety and Efficacy/Performance of DAV132 in Hospitalized Patients at High Risk for Clostridium Difficile Infection and Who Receive Fluoroquinolones for the Treatment of Acute Infections",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). ,N/A,2018-10-09,2018-10-31,260,Completed,Da Volterra,Syneos Health,bulgaria;germany;romania;serbia;bulgaria;germany;romania;serbia,Device: DAV132,"
Inclusion Criteria. Eligible patients for the study must meet ALL the following inclusion
criteria:
1. Male or female =18 years of age
2. Hospitalized patients requiring a systemic antibiotic treatment for a proven or
strongly suspected bacterial infection (lower respiratory tract infection [LRTI],
complicated urinary tract infection [cUTI]) or prophylactic treatment of febrile
neutropenia for neutropenic patient
3. Patients who are intended to receive one of the following FQs: moxifloxacin,
levofloxacin, or ciprofloxacin, by oral or parenteral route, for an intended duration
of 5 days (minimum) to 21 days (maximum), in monotherapy
4. Patients expected to stay in hospital for at least 3 days after randomization
5. Patients with the following conditions:
- Previous history of CDI (no more than 2 episodes) within six months prior to study
inclusion
OR
- Patient aged =65 years, and presenting with at least two of the following:
- Previous cumulated exposure of at least 5 days to any antibiotics within the last
90 days
- Patients who have at least one concurrent severe comorbidity among the following:
malignant disease, chronic renal failure, cardiopulmonary condition (such as
chronic congestive heart failure or severe arterial hypertension), diabetes
mellitus, or liver cirrhosis
- Previous hospitalization of more than 72h within the last 90 days, or patient
receiving long-term nursing care for more than one month within the last 90 days
6. Female patients participating in the study must be:
- of non-childbearing potential: surgically sterilized at least 3 months prior to
inclusion, or postmenopausal (menopause is defined as being aged >60 years, or aged
between 45 and 60 years and being amenorrheic for =2 years)
OR
- of childbearing potential, and:
• using an efficient double contraception from inclusion up to 24 hours after the end
of the treatment period: hormonal contraception (including patch, contraceptive ring,
etc.), intra-uterine device, or other mechanical contraception method
AND
condom, or diaphragm or cervical/vault cap, or spermicide
AND
must have a negative urine pregnancy test prior to inclusion to the study.
7. Patients who have given their written informed consent prior to undertaking any
study-related procedure.
Exclusion Criteria: Eligible patients for this study will be excluded if any of the
following conditions are present:
1. Antibacterial treatment within seven days before randomization
2. Fluoroquinolone indication other than LRTI, cUTI, or febrile neutropenia prophylaxis
3. Patients with suspected or diagnosed CDI at screening, and/or receiving a treatment
effective against CDI
4. Patients with diarrhea corresponding to Bristol stool chart types 5-7, combined with a
stool frequency of at least three stools in 24 or fewer consecutive hours, regardless
of its etiology
5. Patients using probiotics for prevention of CDI and refusing to stop them at inclusion
and during the study
6. Patients currently taking activated charcoal
7. Patients who have received a fecal microbial transplantation within the last 90 days
prior to study screening
8. A critically ill patient for whom transfer to an intensive care unit is scheduled, or
patient who may likely have critical clinical deterioration within 48 hours;
9. Patients with serious, uncontrolled disease, including but not limited to neutropenia
expected to last >7 days (Investigator discretion) or with an estimated life
expectancy shorter than 6 months
10. Patients diagnosed with any cancer requiring taxane-based chemotherapy
11. Patients with digestive stoma, known conditions at risk for intestinal obstruction, or
known achlorhydria
12. Contra-indication to oral therapy (eg, severe nausea/vomiting or ileus) or patient
having tube feeding
13. Patients unable or expected to be unable within 48 hours to receive a medication by
oral route administration
14. Known hypersensitivity to the activated charcoal, or to any of the constituents or
excipients of DAV132
15. Patients taking any drug/medication acting on (eg, metronidazole; sulfasalazine) or
absorbed in the colon.
16. Female patients planning a pregnancy, pregnant or breastfeeding
17. Patients already included into this study
18. Patients in an exclusion period of a previous study
19. Patients with any social or logistical condition which in the opinion of the
Investigator, may interfere with the conduct of the study, such as incapacity to
understand well, not willing to collaborate, or cannot easily be contacted after
discharge
20. Patients not covered by a health insurance system where applicable and in compliance
with the recommendations of the national laws in force relating to biomedical
research.
21. Patients under administrative or legal supervision.
",NULL,Safety endpoint: Proportion of patients having at least one adverse event (AE) related to DAV132 and/or to fluoroquinolones (FQs) and which relationship to product (DAV132 or FQ) is confirmed by the Independent Adjudication Committee (IAC).,"Safety endpoint: Number of AEs and proportion of patients with at least one AE;Efficacy/performance endpoint, clinical:Proportion of patients with CDI;Efficacy/performance endpoint, clinical: Proportion of patients with AAD;Efficacy/performance endpoint, clinical: Plasma levels of FQs;Efficacy/performance endpoint, biological: Level of free fecal concentrations of FQs;Efficacy/performance endpoint, biological: Level of a-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Change from D1 of a-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Levels of ß-diversity of the intestinal microbiota;Efficacy/performance endpoint, biological: Proportion of patients with resistant bacteria and/or yeasts in feces;Efficacy/performance endpoint, biological: Proportion of patients with at least one occurrence of resistant bacteria and yeasts in feces (among patients negative at baseline);Efficacy/performance endpoint, biological: Proportion of patients with acquisition of intestinal colonization by C. difficile (among patients negative at baseline)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-10-31,2018-10-09,2018-10-09,260,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2019-08-29,TRUE,FALSE,FALSE
897,NCT03672591,NA,NCT03672591,NCT: 2018-09-04 ICTRP: 2018-09-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 40 ICTRP: 40 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Poster,https://doi.org/10.1186/s13054-018-1973-5,2018-03-29,2018-09-14,NA,2018-11-30,2019-06-30,Observational,Renal Hemodynamics in Patients With HFpEF,Cross-sectional Observational Single-center Study to Evaluate Renal Hemodynamics in Patients With Heart Failure and Preserved Ejection Fraction,Completed,NA,40,Actual,University of Erlangen-Nürnberg Medical School,Renal plasma flow,"Flow mediated vasodilation;Wall to lumen ratio of retinal arterioles;Retinal capillary flow;Office and 24-hour systolic, diastolic and mean ambulatory blood pressure;Central systolic pressure;Pulse pressure;Pulse wave velocity;Glomerular filtration rate;Filtration fraction;Renal vascular resistance;Intraglomerular pressure",CRC2018HFpEF,Renal Hemodynamics in Patients With HFpEF,Cross-sectional Observational Single-center Study to Evaluate Renal Hemodynamics in Patients With Heart Failure and Preserved Ejection Fraction,NULL,NULL,Observational,,,2018-09-04,2018-11-30,40,Completed,University of Erlangen-Nürnberg Medical School,NULL,germany,Other: Renal clearance examination,"
Inclusion Criteria:
- Patients in good and stable health condition
- Informed consent has to be given in written form
- HFpEF in stable conditions according to 2016 ESC guidelines definition14
- LVEF = 50%
- symptoms and/or signs of CHF
- NT-proBNP > 125 pg/ml
- At least one additional criterion: relevant structural heart disease (left
ventricular hypertrophy and/or left atrial enlargement and/or diastolic
dysfunction
Exclusion Criteria:
- Uncontrolled diabetes (fasting plasma glucose = 240 mg/dl, HbA1c = 10%)
- Uncontrolled arterial hypertension (= 180/110 mmHg)
- Any history of stroke, transient ischemic attack, instable angina pectoris or
myocardial infarction within the last 6 months prior to study inclusion
- Significant valvular heart disease
- Known hypertrophic obstructive cardiomyopathy or known pericardial constriction
- Atrial fibrillation with a resting heart rate > 90 bpm
- Heart transplant recipient
- Sickle cell anemia
- Pheochromocytoma
- Myasthenia gravis
- Subclinical or clinical hyperthyroidism
- Allergic reaction to iodine
- Medication with amiodarone
- Estimated glomerular filtration rate < 30 ml/min/1.73m²
- Significant laboratory abnormalities such as Serum Glutamate-Oxaloacetate-Transaminase
(SGOT) or Serum Glutamate-Pyruvate-Transaminase (SGPT) levels more than 3 times above
the upper limit of normal range
- Patients in unstable conditions due to any kind of serious disease, that infers with
the conduction of the trial
- History of epilepsia and history of seizures
- Patients suffering from cataract or glaucoma
- Diabetic retinopathy
- Drug or alcohol abuse
- Pregnant and breast-feeding patients
- Body mass index > 40 kg/m²
- Participation in another clinical study within 30 days prior to visit 1
- Individuals at risk for poor protocol adherence
- Subjects who do not give written consent, that pseudonymous data will be transferred
in line with the duty of documentation and the duty of notification according to § 12
and § 13 GCP-V
",NULL,Renal plasma flow,"Flow mediated vasodilation;Wall to lumen ratio of retinal arterioles;Retinal capillary flow;Office and 24-hour systolic, diastolic and mean ambulatory blood pressure;Central systolic pressure;Pulse pressure;Pulse wave velocity;Glomerular filtration rate;Filtration fraction;Renal vascular resistance;Intraglomerular pressure",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-11-30,2018-09-04,2018-09-04,40,Observational,FALSE,FALSE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,2019-07-08,TRUE,FALSE,FALSE
981,NCT03638778,NA,NCT03638778,NCT: 2018-08-08 ICTRP: 2018-08-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 105 ICTRP: 105 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-08-20,NA,2018-08-17,2018-12-05,Interventional,Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men,A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects,Completed,Phase 1,105,Actual,Novo Nordisk A/S,"AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing","Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing;tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing;AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing;t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing;Number of treatment emergent adverse events",U1111-1206-6210;2017-005023-24;NN9924-4427,Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men,A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects,,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1,2018-08-08,2018-08-17,105,Completed,Novo Nordisk A/S,NULL,germany,Drug: Semaglutide 3 mg;Drug: Semaglutide 7 mg;Drug: Semaglutide B 3 mg;Drug: Semaglutide B 7 mg;Drug: Semaglutide C 3 mg;Drug: Semaglutide C 7 mg;Drug: Semaglutide D 3 mg;Drug: Semaglutide D 7 mg,"
Inclusion Criteria: - Male, aged 18-64 years (both inclusive) at the time of signing
informed consent. - Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive). -
Considered to be generally healthy based on the medical history, physical examination, and
the results of vital signs, electrocardiogram and clinical laboratory tests performed
during the screening visit, as judged by the investigator. Exclusion Criteria: - Glycated
haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening. - Use of
tobacco and nicotine products, defined as any of the below: a) Smoking more than 5
cigarettes or the equivalent per day. b) Not willing to refrain from smoking and use of
nicotine substitute products during the in-house period(s). - History* of major surgical
procedures involving the stomach potentially affecting absorption of trial products (e.g.,
subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Presence of
clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders
potentially affecting absorption of drugs or nutrients, as judged by the investigator. -
Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or
medullary thyroid carcinoma*. - History* or presence of pancreatitis (acute or chronic).
*As declared by subject.
",NULL,"AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing","Cmax,sema,day10, maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing;tmax,sema,day10, time to maximum observed semaglutide plasma concentration from 0 to 24 hours after the 10th dosing;AUC0-30min,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 30 minutes after the 10th dosing;t½,sema,day10, terminal half-life of semaglutide up to 35 days after the 10th dosing;Number of treatment emergent adverse events",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-08-17,2018-08-08,2018-08-08,105,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2019-11-13,TRUE,FALSE,FALSE
1040,NCT03617640,NA,NCT03617640,NCT: 2018-07-24 ICTRP: 2018-07-24 DRKS: NA,1,1,NA,0,NA,NA,Inclusion criteria do not fit cohorts: Observational study of Hirschprung's disease (key) but IC mention only bowel resection,NA,NA,NA,4,1,no AM,4,1,no AM,NCT: Anticipated 180 ICTRP: 180 DRKS: NA,50,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,ganzer Artikel,https://doi.org/10.1016/j.jcmgh.2021.03.004,2021-03-16,2018-08-06,NA,2015-02-28,2025-02-28,Observational,Neuro-Immune Interactions in the Gut,The Enteric Nervous System as Modulator of Mucosal Immune Cells,Recruiting,NA,180,Anticipated,University Children's Hospital Basel,Phenotypic analysis of immune and nervous cell populations;Expression profil;Histological analysis,Microbial metagenomics sequencing;Identifying genetic defect,EKNZ 2015-049,Neuro-Immune Interactions in the Gut,The Enteric Nervous System as Modulator of Mucosal Immune Cells,;simone.keck@unibas.ch,;simone.keck@unibas.ch,Observational,,,2018-07-24,2015-02-28,180,Recruiting,University Children's Hospital Basel,"University Children's Hospital, Zurich;Inselspital Universität Bern;Kinderspital St. Gallen;Bâtiment Hospitalier CHUV;Universität Klinikum Heidelberg;Luzerner Kantonsspital;Hôpitaux Universitaires Genève;Ospedale Regionale di Bellinzona e Valli",germany;switzerland;germany;switzerland,NULL,
Inclusion Criteria:
Informed consent
Exclusion Criteria:
No signed informed consent No blood from patients with weak general state of health
,NULL,Phenotypic analysis of immune and nervous cell populations;Expression profil;Histological analysis,Microbial metagenomics sequencing;Identifying genetic defect,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-02-28,2018-07-24,2018-07-24,180,Observational,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2015,2020-11-03,TRUE,FALSE,FALSE
1057,NCT03607422,NA,NCT03607422,NCT: 2018-07-25 ICTRP: 2018-07-25 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,5,NA,NA,5,NA,NA,NCT: Anticipated 810 ICTRP: 810 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2018-07-31,NA,2018-07-27,2023-07-20,Interventional,A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (Measure Up 2),"A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis","Active, not recruiting",Phase 3,918,Actual,AbbVie,Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline;Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at Least Two Grades of Reduction from Baseline,Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 from Baseline for Participants with Worst Pruritus NRS ≥ 4 at Baseline;Percentage of Participants Achieving EASI 90;Percentage of Participants Achieving EASI 75;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 for Participants with Worst Pruritus NRS ≥ 4 at Baseline and Randomized to Dose A;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) ≥ 4 for Participants with Worst Pruritus NRS ≥ 4 at Baseline and Randomized to Dose B;Percentage of Participants Experiencing a Flare;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score ≥ 12 (Minimal Clinically Important Difference (MCID)) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score ≥ 4 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) 7-item Total Symptom Score (TSS-7) ≥ 28 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Emotional State Domain score ≥ 11 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Daily Activities Score ≥ 14 (MCID) from Baseline;Percentage of Participants Achieving EASI 100,2018-001383-28;M18-891,A Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis (Measure Up 2),"A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2018-07-25,2018-07-27,918,"Active, not recruiting",AbbVie,NULL,"united states;american samoa;australia;austria;belgium;bulgaria;canada;croatia;czechia;denmark;france;germany;greece;hungary;ireland;italy;korea, republic of;netherlands;new zealand;portugal;singapore;spain;taiwan;united kingdom;american samoa;australia;austria;belgium;bulgaria;canada;croatia;czechia;denmark;france;germany;greece;hungary;ireland;italy;korea, republic of;netherlands;new zealand;portugal;singapore;spain;taiwan;united kingdom;united states",Drug: Upadacitinib;Drug: Placebo for Upadacitinib,"
Inclusion Criteria:
- Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years
of age
- Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
Baseline
- Active moderate to severe AD defined by Eczema Area and Severity Index (EASI),
Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
- Candidate for systemic therapy or have recently required systemic therapy for AD
- Documented history (within 6 months prior to Baseline) of inadequate response to
topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
systemic treatment for AD or for whom topical treatments are otherwise medically
inadvisable due to side effects or safety risks
Exclusion Criteria:
- Prior exposure to any Janus kinase (JAK) inhibitor
- Unable or unwilling to discontinue current AD treatments prior to the study
- Requirement of prohibited medications during the study
- Other active skin diseases or skin infections requiring systemic treatment or would
interfere with appropriate assessment of atopic dermatitis lesions
- Female subject who is pregnant, breastfeeding, or considering pregnancy during the
study
",NULL,Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index (EASI 75) from Baseline;Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at Least Two Grades of Reduction from Baseline,Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 from Baseline for Participants with Worst Pruritus NRS = 4 at Baseline;Percentage of Participants Achieving EASI 90;Percentage of Participants Achieving EASI 100;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Daily Activities Score = 14 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in ADerm-IS Emotional State Domain score = 11 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) 7-item Total Symptom Score (TSS-7) = 28 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Symptom Scale (ADerm-SS) Skin Pain Score = 4 (MCID) from Baseline;Percentage of Participants Achieving an Improvement (Reduction) in Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain Score = 12 (Minimal Clinically Important Difference (MCID)) from Baseline;Percentage of Participants Experiencing a Flare;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 for Participants with Worst Pruritus NRS = 4 at Baseline and Randomized to Dose B;Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (NRS) = 4 for Participants with Worst Pruritus NRS = 4 at Baseline and Randomized to Dose A;Percentage of Participants Achieving EASI 75,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-07-27,2018-07-25,2018-07-25,918,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-12-04,TRUE,FALSE,TRUE
1069,NCT03600818,NA,NCT03600818,NCT: 2018-07-17 ICTRP: 2018-07-17 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,"no metric for ""sustained"" remission",4,NA,no AM,NCT: Anticipated 280 ICTRP: 280 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-07-26,NA,2018-10-09,2022-12-31,Interventional,Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica",Suspended,Phase 3,280,Anticipated,Sanofi,Proportion of patients with sustained remission,Components of sustained remission (composite measure);Cumulative corticosteroid dose;Time to first polymyalgia rheumatica (PMR) flare;Change in glucocorticoid toxicity index;Adverse events;Pharmacokinetic,2017-002989-42;U1111-1201-0777;EFC15160,Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2018-07-17,2018-10-09,280,Suspended,Sanofi,Regeneron Pharmaceuticals,united states;argentina;australia;belgium;canada;estonia;france;germany;hungary;israel;italy;japan;netherlands;russian federation;spain;switzerland;united kingdom;argentina;australia;belgium;canada;estonia;france;germany;hungary;israel;italy;japan;netherlands;russian federation;spain;switzerland;united kingdom;united states,Drug: Sarilumab SAR153191 (REGN88);Drug: Sarilumab-matching placebo;Drug: Prednisone;Drug: Prednisone-matching placebo;Drug: Prednisone,"
Inclusion criteria :
- Diagnosis of polymyalgia rheumatica (PMR) according to European League Against
Rheumatism/American College of Rheumatology classification criteria.
- Patients must be on prednisone of at least 7.5 mg/day (or equivalent) and not
exceeding 20 mg/day at screening and during the screening period.
- Patient is willing and able to take prednisone of 15 mg/day at randomization.
- Patients must have a history of being treated for at least 8 weeks with prednisone
(=10 mg/day or equivalent).
- Patient must have had at least one episode of unequivocal PMR flare while attempting
to taper prednisone at a dose that is =7.5 mg/day (or equivalent) within the past 12
Weeks prior to screening:
- Unequivocal symptoms of PMR flare include shoulder and/or hip girdle pain associated
with inflammatory stiffness.
- Patients must have erythrocyte sedimentation rate =30 mm/hr and/or C-reactive protein
=10 mg/L associated with PMR disease activity within 12 weeks prior to screening.
Exclusion criteria:
- Diagnosis of giant cell arteritis (e.g., persistent or recurrent localized headache,
temporal artery or scalp tenderness, jaw claudication, extremity claudication, blurry
or loss of vision, symptoms of stroke).
- Diagnosis of active fibromyalgia.
- Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective
tissue diseases, such as but not limited to systemic lupus erythematosus, systemic
sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing
spondylitis.
- Concurrent diagnosis of rhabdomyolysis or neuropathic muscular diseases.
- Inadequately treated hypothyroidism.
- Organ transplant recipient.
- Therapeutic failure including inadequate response or intolerance, or contraindication,
to biological IL-6 antagonist.
- Any prior (within the defined period below) or concurrent use of immunosuppressive
therapies but not limited to any of the following:
- Janus kinase inhibitor within 4 weeks of baseline.
- Alkylating agents including cyclophosphamide within 6 months of baseline.
- Cell-depletion agents (e.g., anti CD20) without evidence of recovery of B cells to
baseline level.
- Tumor necrosis factor inhibitors within 2-8 weeks (etanercept within 2 weeks,
infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least
5 half-lives have elapsed, whichever is longer.
- Abatacept within 8 weeks of baseline.
- Anakinra within 1 week of baseline.
- Cyclosporine, azathioprine or mycophenolate mofetil or leflunomide within 4 weeks of
baseline.
- Unstable methotrexate (MTX) dose and/or MTX dose >15mg/week within 3 months of
baseline
- Concurrent use of systemic CS for conditions other than PMR.
- Pregnant or breastfeeding woman.
- Patients with active or untreated latent tuberculosis.
- Patients with history of invasive opportunistic infections.
- Patients with fever associated with infection or chronic, persistent or recurring
infections requiring active treatment.
- Patients with uncontrolled diabetes mellitus.
- Patients with non-healed or healing skin ulcers.
- Patients who received any live, attenuated vaccine within 3 months of baseline.
- Patients who are positive for hepatitis B, hepatitis C and/or HIV.
- Patients with a history of active or recurrent herpes zoster.
- Patients with a history of or prior articular or prosthetic joint infection.
- Prior or current history of malignancy.
- Patients who have had surgery within 4 weeks of screening or planned surgery during
study.
- Patients with a history of inflammatory bowel disease or severe diverticulitis or
previous gastrointestinal perforation.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
",NULL,Proportion of patients with sustained remission,Components of sustained remission (composite measure);Cumulative corticosteroid dose;Time to first polymyalgia rheumatica (PMR) flare;Change in glucocorticoid toxicity index;Adverse events;Pharmacokinetic,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-10-09,2018-07-17,2018-07-17,280,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-04-14,TRUE,FALSE,TRUE
1090,NCT03588390,NA,NCT03588390,NCT: 2018-07-06 ICTRP: 2018-07-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no AM,5,NA,NA,NCT: Actual 63 ICTRP: 63 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-07-17,NA,2018-07-31,2018-11-14,Interventional,This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated.,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 1323495 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)",Completed,Phase 1,63,Actual,Boehringer Ingelheim,Number [N (%)] of subjects with drug-related adverse events,AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity);Cmax (maximum measured concentration of the analyte in plasma),2017-004899-62;1405-0001,This Study in Healthy Men Tests How Different Doses of BI 1323495 Are Taken up in the Body and How Well They Are Tolerated.,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 1323495 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)",NULL,NULL,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). ,Phase 1,2018-07-06,2018-07-31,63,Completed,Boehringer Ingelheim,NULL,germany,Drug: BI 1323495;Drug: BI 1323495;Drug: BI 1323495;Drug: Placebo;Drug: Placebo;Drug: Placebo,"
Inclusion Criteria:
- Healthy male subjects according to the assessment of the investigator, based on a
complete medical history including a physical examination, vital signs (Blood Pressure
[BP], Pulse Rate [PR]), 12-lead Electrocardiogram [ECG], and clinical laboratory tests
- Age of 18 to 45 years (incl.)
- Body Mass Index [BMI] of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in
accordance with Good Clinical Practice[ GCP] and local legislation
Exclusion Criteria:
- Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR]
or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant
by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the
investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)
- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)
- Use of drugs within 30 days prior to administration of trial medication if that might
reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered
within 60 days prior to planned administration of trial medication, or current
participation in another trial involving administration of investigational drug
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 30 g per day)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial
medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to
administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval such as QTc intervals that are
repeatedly greater than 450 ms or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure,
hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance,
because considered not able to understand and comply with study requirements, or has a
condition that would not allow safe participation in the study
In addition, the following trial-specific exclusion criteria apply:
- Male subjects with female partner of childbearing potential who are unwilling to use
male contraception (condom or sexual abstinence) from the first administration of
trial medication until 30 days after last administration of trial medication
- Current or history of relevant kidney, urinary tract diseases or abnormalities (e.g.
nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal
failure)
- Estimated glomerular filtration rate according to CKD-EPI formula < 90 mL/min at
screening
- Within 10 days prior to administration of trial medication, use of any drug that could
reasonably inhibit platelet aggregation or coagulation (e.g., acetylsalicylic acid)
- Further exclusion criteria apply
",NULL,Number [N (%)] of subjects with drug-related adverse events,AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity);Cmax (maximum measured concentration of the analyte in plasma),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-07-31,2018-07-06,2018-07-06,63,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2019-01-16,TRUE,FALSE,FALSE
1123,NCT03575130,NA,NCT03575130,NCT: 2018-06-08 ICTRP: 2018-06-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no AM,5,NA,NA,NCT: Anticipated 21 ICTRP: 21 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-07-02,NA,2018-06-05,2018-12-31,Interventional,Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy,Prospective Single-centre Randomized Observer-blind Placebo-controlled Parallel-group Phase IIa Clinical Trial to Investigate the Safety and Efficacy of Ripasudil 0.4% Eye Drops After Descemetorhexis in Patients With Moderate to Advanced Fuchs Endothelial Corneal Dystrophy (FECD),Unknown status,Phase 2,21,Anticipated,University of Erlangen-Nürnberg Medical School,The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.,"rate of adverse event, adverse reaction, serious adverse event, serious adverse reaction and suspected unexpected serious adverse reaction;effect of ripasudil on corneal endothelial cell density (ECD);effect of ripasudil on corneal thickness;effect of on visual acuity (BCVA);effect of ripasudil on contrast sensitivity;assess the need of rescue therapy (DMEK)",2017-002490-19,Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy,Prospective Single-centre Randomized Observer-blind Placebo-controlled Parallel-group Phase IIa Clinical Trial to Investigate the Safety and Efficacy of Ripasudil 0.4% Eye Drops After Descemetorhexis in Patients With Moderate to Advanced Fuchs Endothelial Corneal Dystrophy (FECD),friedrich.kruse@uk-erlangen.de,friedrich.kruse@uk-erlangen.de,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 2,2018-06-08,2018-06-05,21,Unknown status,University of Erlangen-Nürnberg Medical School,NULL,germany,Drug: Ripasudil eye drops;Drug: Optive eye drops;Procedure: Descemetorhexis,"
Inclusion Criteria:
1. Written informed consent obtained from the subject
2. Understanding of study procedures and willingness to abide by all procedures during
the course of the study.
3. Age range: 18-70 years
4. Diagnosis of moderate to advanced FECD with central guttae and clinical relevant
corneal endothelial cell loss of <1,000 cells/mm2 and clinical indication of surgical
intervention (descemetorhexis) with or without accompanying cataract operation
5. Reduced visual acuity, defined as BCVA <20/30
6. Woman of childbearing potential must be using a highly effective method of birth
control.
",NULL,The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.,"rate of adverse event, adverse reaction, serious adverse event, serious adverse reaction and suspected unexpected serious adverse reaction;effect of ripasudil on corneal endothelial cell density (ECD);effect of ripasudil on corneal thickness;assess the need of rescue therapy (DMEK);effect of ripasudil on contrast sensitivity;effect of on visual acuity (BCVA)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-06-05,2018-06-08,2018-06-08,21,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2018,2018-07-10,TRUE,FALSE,TRUE
1152,NCT03566238,NA,NCT03566238,NCT: 2018-05-25 ICTRP: 2018-05-25 DRKS: NA,1,NA,NA,1,NA,NA,"unspecific criteria for PFIC (which genes, when is s-BA elevated?)",2,NA,NA,4,NA,no AM,5,NA,NA,NCT: Anticipated 60 ICTRP: 60 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-06-25,NA,2018-05-16,2020-07-28,Interventional,This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC 1 or 2,"A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)",Completed,Phase 3,62,Actual,Albireo,Change in pruritus (US);Bile acid reduction (EU and rest of world),"Bile acid reduction (US);Change in pruritus (EU and rest of world);Change in fasting serum bile acids (s-BA);Change in serum ALT concentration;Change in growth;Proportion of patients achieving meaningful reduction in caregiver-reported observed scratching;Change in sleep disturbances;Change in sleep disturbances, including number of awakenings;Change in patient-reported itch severity;Number of patients undergoing biliary diversion surgery or liver transplantation",A4250-005,This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC 1 or 2,"A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)",NULL,NULL,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 3,2018-05-25,2018-05-16,62,Completed,Albireo,NULL,united states;australia;belgium;canada;france;germany;israel;italy;netherlands;poland;saudi arabia;spain;sweden;turkey;united kingdom;australia;belgium;canada;france;germany;israel;italy;netherlands;poland;saudi arabia;spain;sweden;turkey;united kingdom;united states,Drug: A4250 (odevixibat);Drug: Placebo,"
Key Inclusion Criteria:
- A male or female patient with a clinical diagnosis of PFIC Type 1 or 2 and with a body
weight above 5 kg
- Patient must have clinical genetic confirmation of PFIC-1 or PFIC-2
- Patient must have elevated s-BA concentration
- Patient must have history of significant pruritus and a caregiver reported observed
scratching in the eDiary
- Patient and/or legal guardian must sign informed consent (and assent) as appropriate.
- Patients will be expected to have a consistent caregiver(s) for the duration of the
study
- Caregivers and age-appropriate patients (=8 years of age) must be willing and able to
use an eDiary device as required by the study
Key Exclusion Criteria:
- Patient with pathologic variations of the ABCB11 gene that predict complete absence of
the BSEP protein
- Patient with past medical history or ongoing presence of other types of liver disease
including, but not limited to, the following:
1. Biliary atresia of any kind
2. Benign recurrent intrahepatic cholestasis, indicated by any history of normal s
BAs
3. Suspected or proven liver cancer or metastasis to the liver on imaging studies
4. Histopathology on liver biopsy that is suggestive of alternate non-PFIC related
etiology of cholestasis
- Patient with past medical history or ongoing chronic diarrhea
- Any patient with suspected or confirmed cancers except for basal cell carcinoma
- Patient with a past medical history of chronic kidney disease with an impaired renal
function and a glomerular filtration rate <70 mL/min/1.73 m^2
- Patient with surgical history of disruption of the enterohepatic circulation (biliary
diversion surgery) within 6 months prior to start of Screening Period
- Patient has had a liver transplant or a liver transplant is planned within 6 months of
randomization
- Decompensated liver disease
- Patient suffers from uncontrolled, recalcitrant pruritic condition other than PFIC
- Patient who has been previously treated with an IBAT inhibitor whose pruritus has not
responded to treatment
",NULL,Change in pruritus (US);Bile acid reduction (EU and rest of world),"Bile acid reduction (US);Change in pruritus (EU and rest of world);Change in fasting serum bile acids (s-BA);Change in serum ALT concentration;Change in growth;Proportion of patients achieving meaningful reduction in caregiver-reported observed scratching;Change in sleep disturbances;Change in sleep disturbances, including number of awakenings;Change in patient-reported itch severity;Number of patients undergoing biliary diversion surgery or liver transplantation",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-05-16,2018-05-25,2018-05-25,62,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2018,2020-09-16,TRUE,FALSE,TRUE
1201,NCT03548506,NA,NCT03548506,NCT: 2018-04-18 ICTRP: 2018-04-18 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,3,NA,"no metric, no AM",4,NA,no AM,NCT: Anticipated 20 ICTRP: 20 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-06-07,NA,2018-04-19,2020-12-31,Interventional,Subthalamic Steering for Therapy Optimization in Parkinson's Disease,Subthalamic Steering for Therapy Optimization in Parkinson's Disease,Unknown status,N/A,20,Anticipated,University Hospital Tuebingen,Muscle Rigidity,Freezing of gait (2);Quality of life;Clinical motor and non-motor symptoms (1);Clinical motor and non-motor symptoms (2);Clinical motor and non-motor symptoms (3);Clinical motor and non-motor symptoms (4);Clinical motor and non-motor symptoms (5);Clinical motor and non-motor symptoms (6);Clinical motor and non-motor symptoms (7);Clinical motor and non-motor symptoms (8);Neurocognitive and non-motor symptoms (1);Neurocognitive and non-motor symptoms (2);Neurocognitive and non-motor symptoms (3);Neurocognitive and non-motor symptoms (4);Neurocognitive and non-motor symptoms (5);Neurocognitive and non-motor symptoms (6);Neurocognitive and non-motor symptoms (7);Neuropsychiatric symptoms (1);Neuropsychiatric symptoms (2);Freezing of gait (1),SANTOP,Subthalamic Steering for Therapy Optimization in Parkinson's Disease,Subthalamic Steering for Therapy Optimization in Parkinson's Disease,;;alireza.gharabaghi@uni-tuebingen.de;alireza.gharabaghi@uni-tuebingen.de,;;alireza.gharabaghi@uni-tuebingen.de;alireza.gharabaghi@uni-tuebingen.de,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). ",N/A,2018-04-18,2018-04-19,20,Unknown status,University Hospital Tuebingen,Abbott,germany,Device: Omnidirectional Deep Brain Stimulation of STN;Device: Directional Deep Brain Stimulation of STN,"
Inclusion Criteria:
- Written informed consent
- Idiopathic Parkinson's disease (according to the British Brain Bank criteria
(Hughes, 1992) including genetic forms
Exclusion Criteria:
- Cognitive impairment (Mini Mental State Exam < 20)
- Suicidality, Psychosis
- Other severe pathological chronic condition that might confound treatment effects or
interpretation of the data
- Pregnancy
",NULL,Muscle Rigidity,Clinical motor and non-motor symptoms (1);Clinical motor and non-motor symptoms (2);Clinical motor and non-motor symptoms (3);Clinical motor and non-motor symptoms (4);Clinical motor and non-motor symptoms (5);Clinical motor and non-motor symptoms (6);Clinical motor and non-motor symptoms (7);Clinical motor and non-motor symptoms (8);Neurocognitive and non-motor symptoms (1);Neurocognitive and non-motor symptoms (2);Neurocognitive and non-motor symptoms (3);Neurocognitive and non-motor symptoms (4);Neurocognitive and non-motor symptoms (5);Neurocognitive and non-motor symptoms (6);Neurocognitive and non-motor symptoms (7);Neuropsychiatric symptoms (1);Neuropsychiatric symptoms (2);Freezing of gait (1);Freezing of gait (2);Quality of life,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-04-19,2018-04-18,2018-04-18,20,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,2018-06-08,TRUE,FALSE,FALSE
1204,NCT03547986,NA,NCT03547986,NCT: 2018-05-18 ICTRP: 2018-05-18 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,Description deemed sufficient,5,NA,rated 6 because no time frame necessary,5,NA,rated 6 because no time frame necessary,NCT: Anticipated 150 ICTRP: 150 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no intervention (very unspecific),kein Artikel,NA,NA,2018-06-06,NA,2018-11-09,2021-12-31,Interventional,BIO REsponse Adapted Combination Therapy Pilot Study,Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive,"Active, not recruiting",N/A,150,Anticipated,Biotronik AG,diagnostic accuracy of duplex ultrasound,"diagnostic accuracy of intraarterial pressure measurement;diagnostic accuracy of intraarterial pressure measurement with IVUS;Target lesion stenting rate;Number of stents used per target lesion;Average stent length per target lesion;Average target lesion length stented (full, spot);DCB technical success;Stent technical success;Procedural success;Primary Patency;Major Adverse Event (MAE);Major Adverse Cardiac Event (MACE);Major Adverse Limb Event (MALE);Clinically driven Target Lesion Revascularization;Major target limb amputation rate;all cause of death rate;Hemodynamic improvement;Rate of primary sustained clinical improvement;Rate of secondary sustained clinical improvement;Health Related Quality of Life;Walk Impairment;Resource utilisation",C1706,BIO REsponse Adapted Combination Therapy Pilot Study,Evaluation of Adjunctive Procedural Assessments to Diagnose Post Drug-coated Balloon Flow-limiting Dissection and Residual Stenosis When Angiography is Inconclusive,;;,;;,Interventional,Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). ,N/A,2018-05-18,2018-11-09,150,"Active, not recruiting",Biotronik AG,NULL,australia;austria;belgium;france;germany;spain;australia;austria;belgium;france;germany;spain,Diagnostic Test: Duplex Ultrasound (DUS);Diagnostic Test: IVUS with Intraarterial pressure measurement (IAP) if needed,"
Inclusion Criteria:
- Subject has provided written informed consent before any study specific test or
procedure and is willing and able to comply with the required follow-up visits and
procedures
- Subject has a chronic, symptomatic lower limb ischemia defined as Rutherford
categories 2 to 4
Angiographic criteria:
- Single lesion or consecutive single lesions with a healthy segment(s) of = 2cm
in-between
- De novo, restenotic or (re)occluded lesion(s) post Percutaneous Transluminal
Angioplasty in the native superficial femoral artery (SFA) and or the proximal
popliteal artery (PPA)
- Lesion(s) must be located at least 1 cm distal to the profunda femoris artery and at
least 3 cm above the knee joint (radiographic joint space)
- Degree of stenosis =70% by visual angiographic assessment
- Vessel diameter = 4 and = 7 mm
- Patent inflow artery, free from significant lesion (>50%) as confirmed by angiography.
Treatment of the target lesion is acceptable after successful treatment of inflow
iliac and/or common femoral artery lesion. The inflow lesion cannot be treated with a
DCB or a Drug Eluting Stent
- Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with
at least one of the three vessels patent (<50% stenosis) to the ankle or foot with no
planned intervention
Exclusion Criteria:
- Previously stented target lesion
- Target lesion/ previously treated with drug-coated balloon <12 months prior to
enrollment.
- Use of atherectomy, laser or other debulking devices in the target SFA/PPA vessel
during the index procedure.
- Failure to cross the target lesion with the guide wire
- Presence of a complication following pre-dilation of target lesion, which in the
opinion of the investigator would not allow the procedure to be performed in
accordance with the REACT approach
- Presence of aneurysm in the target vessel.
- Prior on planned major amputation (above the ankle) in the target limb
- Acute ischemia and/or acute thrombosis of the target SFA/PPA vessel prior to
enrollment.
- Perforation of the target vessel as evidenced by extravasation of contrast media prior
to enrollment
- Known hypersensitivity or contraindication to contrast media that, in the opinion of
the investigator, cannot be adequately pre-medicated
- Known hypersensitivity/allergy to Paclitaxel or other components of the
investigational devices and comparator (e.g., nitinol, amorphous silicon carbide,
polymer)
- Known hypersensitivity or contraindication to antiplatelet, anticoagulant,
thrombolytic medications that would be administered during the study
- Subject with uncorrected bleeding disorders
- Subject with renal failure
- Life expectancy less than 12 months due to other comorbidities, that in the
investigators opinion, could limit subject ability to comply with the study required
follow-up visits/procedure and threaten the study scientific integrity
- Pregnant, breast feeding, or plan to become pregnant in the next 12 months.
- Current participation in another investigational drug or device clinical study that
has not completed the primary endpoint at the time of enrollment or that upon
investigator judgment could clinically interferes with the current study endpoints
",NULL,diagnostic accuracy of duplex ultrasound,"diagnostic accuracy of intraarterial pressure measurement;diagnostic accuracy of intraarterial pressure measurement with IVUS;Target lesion stenting rate;Number of stents used per target lesion;Average stent length per target lesion;Average target lesion length stented (full, spot);DCB technical success;Stent technical success;Procedural success;Primary Patency;Major Adverse Event (MAE);Major Adverse Cardiac Event (MACE);Major Adverse Limb Event (MALE);Clinically driven Target Lesion Revascularization;Major target limb amputation rate;all cause of death rate;Hemodynamic improvement;Rate of primary sustained clinical improvement;Rate of secondary sustained clinical improvement;Health Related Quality of Life;Walk Impairment;Resource utilisation",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-11-09,2018-05-18,2018-05-18,150,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-08-13,TRUE,FALSE,FALSE
1277,NCT03519698,NA,NCT03519698,NCT: 2018-01-12 ICTRP: 2018-01-12 DRKS: NA,1,1,NA,0,NA,NA,No criteria for disease under investigation,2,1,NA,4,1,no AM,4,1,NA,NCT: Actual 41 ICTRP: 41 DRKS: NA,41,1,1,2,1,NA,single,single,ok,1,NA,ganzer Artikel,https://doi.org/10.1155/2020/2416582,2019-10-08,2018-05-09,NA,2015-12-15,2017-06-22,Interventional,"Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa","Efficacy of Footbaths With Ginger, Mustard & Warm Water Only on Psychophysiological Parameters in Female Adolescents With & Without Anorexia Nervosa - a Randomized, Controlled, Three-arm Study With Cross-over Design",Completed,N/A,41,Actual,ARCIM Institute Academic Research in Complementary and Integrative Medicine,Change in 2-Item Warmth Perception Measure (feet) from t1 to t3,Change in 2-Item Warmth Perception Measure (feet) from t1 to t2;Change in 2-Item Warmth Perception Measure (face) from t1 to t3;Change in 2-Item Warmth Perception Measure (face) from t1 to t2;Change in 2-Item Warmth Perception Measure (hands) from t1 to t3;Change in 2-Item Warmth Perception Measure (hands) from t1 to t2;Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3;Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2;Change in Distal Skin Temperature Measure (feet) from t1 to t3;Change in Distal Skin Temperature Measure (feet) from t1 to t2;Change in Distal Skin Temperature Measure (face) from t1 to t3;Change in Distal Skin Temperature Measure (face) from t1 to t2;Change in Distal Skin Temperature Measure (hands) from t1 to t3;Change in Distal Skin Temperature Measure (hands) from t1 to t2,SWI_05,"Footbaths With Ginger, Mustard & Warm Water Only in Female Adolescents With & Without Anorexia Nervosa","Efficacy of Footbaths With Ginger, Mustard & Warm Water Only on Psychophysiological Parameters in Female Adolescents With & Without Anorexia Nervosa - a Randomized, Controlled, Three-arm Study With Cross-over Design",,,Interventional,Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant). ,N/A,2018-01-12,2015-12-15,41,Completed,ARCIM Institute Academic Research in Complementary and Integrative Medicine,NULL,germany,Other: Warm water;Other: Mustard;Other: Ginger,
Inclusion Criteria:
- Signed informed consent of the parents
- Age 12-18 years
Exclusion Criteria:
- Infectious disease with body temperature above 38 °C
- Skin damages at the lower legs/feet
- Known intolerance/ anaphylaxis to mustard or ginger preparations
- Cardiac arrhythmia
- Pregnancy
- Insufficient knowledge of the German language
- BMI percentile < 10% (for control group)
,NULL,Change in 2-Item Warmth Perception Measure (feet) from t1 to t3,Change in 2-Item Warmth Perception Measure (feet) from t1 to t2;Change in 2-Item Warmth Perception Measure (face) from t1 to t3;Change in 2-Item Warmth Perception Measure (face) from t1 to t2;Change in 2-Item Warmth Perception Measure (hands) from t1 to t3;Change in 2-Item Warmth Perception Measure (hands) from t1 to t2;Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t3;Change in 1-Item Warmth Perception Measure (overall warmth) from t1 to t2;Change in Distal Skin Temperature Measure (feet) from t1 to t3;Change in Distal Skin Temperature Measure (feet) from t1 to t2;Change in Distal Skin Temperature Measure (face) from t1 to t3;Change in Distal Skin Temperature Measure (face) from t1 to t2;Change in Distal Skin Temperature Measure (hands) from t1 to t3;Change in Distal Skin Temperature Measure (hands) from t1 to t2,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-12-15,2018-01-12,2018-01-12,41,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2015,2018-05-08,TRUE,FALSE,FALSE
1285,NCT03517540,NA,NCT03517540,NCT: 2018-04-09 ICTRP: 2018-04-09 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,3,NA,NA,3,NA,NA,NCT: Anticipated 200 ICTRP: 200 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Studienprotokoll,https://doi.org/10.1016/j.cct.2019.105889,NA,2018-05-07,NA,2018-09-11,2020-09-29,Interventional,"Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis. (TANDEM)","A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis","Active, not recruiting",Phase 2,193,Actual,Novartis,Number of participants with Adverse Events,Proportion of participants who have at least a one point improvement in fibrosis;Proportion of participants with resolution of steatohepatitis,2017-004208-24;LJC242A2201J;CLJC242A2201J,"Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis. (TANDEM)","A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis",NULL,NULL,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 2,2018-04-09,2018-09-11,193,"Active, not recruiting",Novartis Pharmaceuticals,Allergan,united states;argentina;belgium;canada;czechia;egypt;estonia;france;germany;hong kong;india;israel;italy;latvia;portugal;russian federation;singapore;spain;switzerland;turkey;united kingdom;argentina;belgium;canada;czechia;egypt;estonia;france;germany;hong kong;india;israel;italy;latvia;portugal;russian federation;singapore;spain;switzerland;turkey;united kingdom;united states,Drug: Tropifexor (LJN452);Drug: Cenicriviroc (CVC),"
Inclusion Criteria:
Written informed consent Male and female patients 18 years or older (at the time of the
screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440
lb) to participate in the study.
Able to communicate well with the investigator, to understand and comply with the
requirements of the study.
Adequate liver biopsy sample for evaluation by Central Reader. Presence of NASH as
demonstrated by histologic evidence based on liver biopsy - NASH with fibrosis stage F2/F3,
demonstrated on liver biopsy during the screening period. Alternatively, a historical
biopsy can be used if performed within 6 months prior to screening.
Exclusion Criteria:
Use of other investigational drugs within 5 half-lives of enrollment or within 30 days
whichever is longer.
History of hypersensitivity to any of the study drugs or its excipients or to drugs of
similar chemical classes.
Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or other
FXR agonist.
Participated in a clinical trial and treated with any investigational product being
evaluated for the treatment of liver fibrosis or NASH in the 6 months before screening.
Patients taking medications prohibited by the protocol. History of treated or untreated
malignancy of any organ system, other than localized basal cell carcinoma of the skin or
treated cervical intraepithelial neoplasia, within the past 5 years, regardless of whether
there is evidence of local recurrence or metastases .
Pregnant or nursing (lactating) women. Women of child-bearing potential. Current or history
of significant alcohol consumption for a period of more than 3 consecutive months within 1
year prior to screening (significant alcohol consumption is defined as more than 20 g/day
in females and more than 30 g/day in males, on average) and/or a score on the modified
AUDIT questionnaire = 8.
Inability to reliably quantify alcohol consumption. History or evidence of ongoing drug
abuse, within the last 6 months prior to randomization.
Prior or planned (during the study) bariatric surgery. Uncontrolled diabetes defined as
HbA1c = 9% at screening Clinical evidence of hepatic decompensation or severe liver
impairment. Previous diagnosis of other forms of chronic liver disease. Calculated eGFR
less than 60 mL/min (using the MDRD formula). History of biliary diversion History of liver
transplantation or planned liver transplant. Known positivity for HIV. History or current
diagnosis of ECG abnormalities indicating significant risk of safety for the patient to
participate.
History of inflammatory bowel disease. Patients who are not candidates for liver biopsy.
Presence of cirrhosis on liver biopsy (F4 by NASH CRN System) or medical history Patients
with an abnormal platelet count (referring to reference ranges from the central lab).
",NULL,Number of participants with Adverse Events,Proportion of participants with resolution of steatohepatitis;Proportion of participants who have at least a one point improvement in fibrosis,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-09-11,2018-04-09,2018-04-09,193,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-07-31,TRUE,FALSE,TRUE
1288,NCT03516201,NA,NCT03516201,NCT: 2018-03-21 ICTRP: 2018-03-21 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Anticipated 250 ICTRP: 250 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-05-04,NA,2018-06-15,2025-05-31,Observational,Oral Health in Bariatric Patients,Oral Health in Bariatric Patients,"Active, not recruiting",NA,100,Actual,University of Göttingen,Oral health of obese adults without bariatric surgery - attachment loss;Oral health of obese adults without bariatric surgery - BOP;Oral health of obese adults without bariatric surgery - dental caries;Oral health of obese adults without bariatric surgery - erosive tooth wear,Oral health of obese adults after bariatric surgery - attachment loss;Oral health of obese adults after bariatric surgery - BOP;Oral health of obese adults after bariatric surgery - dental caries;Oral health of obese adults after bariatric surgery - erosive tooth wear,28/3/17,Oral Health in Bariatric Patients,Oral Health in Bariatric Patients,,,Observational,,,2018-03-21,2018-06-15,100,"Active, not recruiting",University of Göttingen,NULL,germany,NULL,
Inclusion Criteria:
- Age = 18 years
- BMI = 25 kg/m2 without or after bariatric surgery
Exclusion Criteria:
- refusal for participation
- age <18 years
- BMI <25 kg/m2
,NULL,Oral health of obese adults without bariatric surgery - attachment loss;Oral health of obese adults without bariatric surgery - BOP;Oral health of obese adults without bariatric surgery - dental caries;Oral health of obese adults without bariatric surgery - erosive tooth wear,Oral health of obese adults after bariatric surgery - attachment loss;Oral health of obese adults after bariatric surgery - BOP;Oral health of obese adults after bariatric surgery - dental caries;Oral health of obese adults after bariatric surgery - erosive tooth wear,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-06-15,2018-03-21,2018-03-21,100,Observational,FALSE,FALSE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,2020-11-04,TRUE,FALSE,FALSE
1291,NCT03515421,NA,NCT03515421,NCT: 2018-04-10 ICTRP: 2018-04-10 DRKS: NA,0,NA,Seems to be observational,2,NA,NA,NA,2,NA,NA,3,NA,"no metric, no AM (Presumably mean difference)",NA,NA,NA,NCT: Actual 379 ICTRP: 379 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,NA,NA,kein Artikel,NA,NA,2018-05-03,NA,2018-04-09,2018-06-18,Interventional,Project Frazier 3 Regulatory Clinical Evaluation,Project Frazier 3 Regulatory Clinical Evaluation,Completed,N/A,379,Actual,LifeScan Scotland Ltd,User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.;System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.;System Use Evaluation questionnaire;Instructions for Use Evaluation questionnaire.;Marketing Claims Evaluation questionnaire.,,3165622,Project Frazier 3 Regulatory Clinical Evaluation,Project Frazier 3 Regulatory Clinical Evaluation,,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). ,N/A,2018-04-10,2018-04-09,379,Completed,LifeScan Scotland Ltd,Institute for Diabetes-Technology GmbH,germany;united kingdom;germany;united kingdom,Device: Frazier 3 Verio;Device: Frazier 3 UltraPlus,
Summary of Inclusion Criteria
- Age - Subject is at least 12 years old.
- Informed Consent - Subject reads the appropriate Participant Information Sheet and
signs the Informed Consent Form (section 12.0).
- Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
- Language - Subject reads and understands local language
- SMBG status confirmed
- Subject agrees to complete all aspects of the study
Summary of exclusion criteria
- Conflict of Interest
- Pregnancy - Subject is pregnant (as confirmed by Subject)
- User Performance Accuracy Testing - Technical Expertise
,NULL,User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.;System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.;System Use Evaluation questionnaire;Instructions for Use Evaluation questionnaire.;Marketing Claims Evaluation questionnaire.,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-04-09,2018-04-10,2018-04-10,379,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2018,2020-09-08,TRUE,FALSE,FALSE
1301,NCT03511326,NA,NCT03511326,NCT: 2017-08-25 ICTRP: 2017-08-25 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,4,1,no measure specified,NA,NA,"Zusätzlich investigator reported outcomes und Effectiveness assessed at 3 months: lesion complete response
rate",NCT: Actual 50 ICTRP: 50 DRKS: NA,50,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1111/jdv.15422,2019-01-11,2018-04-27,NA,2017-06-07,2017-11-28,Interventional,PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK,"Subject Reported Outcomes on Satisfaction, Safety and Efficacy With Luxerm® in the Field-directed Treatment of Thin or Non-hyperkeratotic and Non-pigmented Actinic Keratosis of the Face or the Scalp",Completed,Phase 4,50,Actual,Galderma,Overall Subject Satisfaction the Day of Treatment After Daylight Session;Overall Subject Satisfaction at Week 12 Post-treatment,,RD.03.SPR.114384,PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK,"Subject Reported Outcomes on Satisfaction, Safety and Efficacy With Luxerm® in the Field-directed Treatment of Thin or Non-hyperkeratotic and Non-pigmented Actinic Keratosis of the Face or the Scalp",,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). ,Phase 4,2017-08-25,2017-06-07,50,Completed,Galderma,NULL,germany,Drug: Methyl Aminolaevulinate 16% Cream,"
Inclusion Criteria:
1. Male or female age > 18 years old.
2. Subject with at least 5 clinically confirmed thin or non-hyperkeratotic and
non-pigmented actinic keratoses in an anatomical area on the face (e.g., forehead or
cheek or chin) excluding nose, eyelids, lips and mucosa, or balding scalp, at baseline
visit.
3. Subject or caregiver capable of performing the skin preparation and Luxerm® treatment
application as per the investigator instructions.
4. Female subject of childbearing potential must have a negative UPT at baseline (UPT
should have a sensitivity of 25 IU/L or less) and agree to be strictly abstinent or
use a highly effective method of birth control during the study (i.e. progestogen-only
oral hormonal contraception; male or female condom; cap, diaphragm or sponge with
spermicide; bilateral tubal ligation; combined (estrogen and progestogen-containing)
oral hormonal contraception, or injectable or implants hormonal contraception (at a
stable dose for at least 1 month prior to baseline); intra-uterine devices inserted at
least 1 month prior to baseline; vasectomized partner for at least 3 months prior to
baseline).
5. Female subject of non-childbearing potential, e.g.: post-menopausal (absence of
menstrual bleeding for 1 year without any other medical reason), hysterectomy or
bilateral ovariectomy.
6. Subject has read and signed the approved informed consent form (ICF) prior to any
participation in the study.
7. Subject has read and signed a Photograph Release Consent Form if he/she is willing to
be photographed.
8. Subject (or caregiver) willing and able to comply with all of the time commitments and
procedural requirements of the clinical trial protocol.
Exclusion Criteria:
1. Subject with a clinical diagnosis of a skin disease other than AK (including
non-melanoma skin cancer) on the target anatomical area.
2. Subject with severe AK (thick, hyperkeratotic AK) per anatomical area (face or scalp).
3. Subject with clinical diagnosis of other skin disease on the target anatomical area.
4. Subject with pigmented AK on the target anatomical area.
5. Subject with melanoma at any location.
6. Immunocompromised subject or requiring immunosuppressive therapies.
7. Subject with porphyria; photosensitivity- related disorders, active infectious
disease.
8. Subject with known or suspected hypersensitivity to the active substance or to any
excipients of Luxerm® (see Summary of Product Characteristics).
9. Female subject who is pregnant, nursing or planning a pregnancy during the study.
10. Subject who has used any of the following topical preparations on the area to be
treated: keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.
glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%)
within 2 days of initiation of treatment.
11. Subject with a wash-out period from baseline for topical or systemic treatment or
medical/surgical procedure in the anatomical area (for AKs) less than the following:
- Retinoids, including tazarotene, adapalene, tretinoin, retinol ==> 4 weeks
- Cryotherapy, diclofenac, corticosteroids or other treatments for AK==> 8 weeks
- Microdermabrasion, laser ablative treatments or chemical peels ==>8 weeks
- 5-FU, imiquimod ==>24 weeks
- Surgical: excision and reconstructive surgery, chemosurgery, ==>12 weeks
- Any Photodynamic Therapy, ingenol mebutate (Pep-005), Radiotherapy and UV
radiation therapy==>12 weeks
- Investigational therapies for Actinic Keratoses==>12 weeks
- Immunosuppressive drugs (such as glucocorticoids, cytostatic, antibodies, drugs
acting on interferon, opioids, TNF binding proteins, Mycophenolate, small
biologics agents)==>12 weeks
12. Subject who is currently participating to/ or who has participated in another
investigational treatment or device research study within 4 weeks of baseline visit.
13. Subject may be unreliable for the study including subjects who engage in excessive
alcohol intake or drug abuse, or subjects who are unable to return for scheduled
follow-up visits.
14. Subject who is unable to communicate or cooperate with the investigator due to
language problems, poor mental development, or impaired cerebral function.
15. Subject who is unwilling to refrain from use of prohibited medication during the
clinical trial (see section 4.3.5).
16. Subject who is vulnerable (such as deprived of freedom) as defined in Section 1.61 of
the International Conference on Harmonisation (ICH) Guideline for Good Clinical
Practice (GCP).
17. Subject with clinically significant abnormal laboratory finding (if any available
report) at the baseline visit or medical/surgical condition (other than for actinic
keratoses), which might, in the Investigator's opinion, interfere with study
evaluations or pose a risk to subject safety during the study.
18. The subject is a study site staff member (investigator, study nurse, etc.) or a
relative of one.
19. Subjects with any condition that may be associated with a risk of poor protocol
compliance
",NULL,Overall Subject Satisfaction the Day of Treatment After Daylight Session;Overall Subject Satisfaction at Week 12 Post-treatment,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-06-07,2017-08-25,2017-08-25,50,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2017,2020-11-16,TRUE,FALSE,TRUE
1345,NCT03497975,NA,NCT03497975,NCT: 2018-03-22 ICTRP: 2018-03-22 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no AM,NCT: Anticipated 240 ICTRP: 240 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-04-13,NA,2018-08-07,2021-12-31,Interventional,PRISM Study-Pruritus Relief Through Itch Scratch Modulation,"A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm , Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)",Recruiting,Phase 2/Phase 3,360,Anticipated,Trevi Therapeutics,Comparison of percentage of responders by arm,Change from baseline for itch-related quality of life: ItchyQoL total score;Change from baseline for Prurigo Nodularis skin lesions;Change from baseline for sleep disturbance,TR11,PRISM Study-Pruritus Relief Through Itch Scratch Modulation,"A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm , Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)",;clinicalops.admin@trevitherapeutics.com,;clinicalops.admin@trevitherapeutics.com,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 2/Phase 3,2018-03-22,2018-08-07,360,Recruiting,Trevi Therapeutics,NULL,united states;austria;france;germany;poland;austria;france;germany;poland;united states,Drug: Nalbuphine ER Tablets;Other: Matching Placebo Tablets,"
Inclusion Criteria:
- Individuals diagnosed with generalized nodular PN, covering 2 separate body parts, and
10 or more pruriginous nodules
- Severe itch due to PN
- Age 18 years and older at the time of consent, and a life expectancy of at least 18
months.
Exclusion Criteria:
- Pruritus due to localized PN (only one body part affected), or less than 10 nodules
- Pruritic dermatoses other than PN that were active/in need of treatment in the last 6
months, such as atopic dermatitis, bullous pemphigoid or other dermatologic conditions
that in the opinion of the Investigator could confound the ability to assess PN
related itch.
- Unresolved acute secondary dermatoses active (unresolved) in the last (a) 4 weeks:
localized contact dermatitis, environmental exposures, superficial burns, or viral
exanthems; (b) 8 weeks: skin or environmental infestations, such as scabies, lice, or
bed bugs.
- Other non-dermatologic disease that could be a potential cause of concomitant pruritus
(e.g., thyroid disease, celiac disease, hepatitis C virus [HCV]) must either have
resolved, been successfully treated (i.e., HCV RNA negative) or must be successfully
managed with stable, optimized treatment (e.g., thyroid replacement, dietary
management with resolution of symptoms, respectively) for at least 3 months prior to
screening
- History of a major psychiatric disorder such as bipolar disorder or schizophrenia.
History of substance abuse in the last 3 years. Individuals using sedating
antidepressants. Individuals using non-sedating antidepressants must be on a stable
dose for a minimum of 8 weeks prior to entering the study.
- Known intolerance (GI, CNS symptoms) or hypersensitivity/drug allergy to opioids.
- Use of certain concomitant medications and treatments within a period prior to the
study, or requirement for these medications during the study:
- Within 14 days prior to screening: opiates, gabapentin, pregabalin, calcineurin
inhibitors, cannabinoid agonists, capsaicin, cryosurgery, topical doxepin,
thalidomide or methotrexate, antihistamines (systemic or topical), and topical
corticosteroids, cryotherapy.
- Within 4 weeks prior to screening: ultraviolet (UV)-therapy, exposure to any
investigational medication, including placebo
- Within 3 months prior to screening: Non-insulin biologics (including monoclonal
antibodies) that modify the immune system,
- Individuals taking monoamine oxidase inhibitors are excluded, as concomitant
opiate use may increase the risk for serotonin syndrome.
- Individuals who have previously received dupilumab or nemolizumab are excluded
- Myocardial infarction or acute coronary syndrome within the previous 3 months, as
reported by the subject.
- Individuals with prolonged QTcF
Individuals with HIV can be included if they meet the following criteria: (a) currently on
a stable (> 6 months stable use) and well tolerated highly active antiretroviral therapy
regimen; (b) CD4 count > 500 cells/mL; and (c) HIV ribonucleic acid (RNA) < 50 copies/mL
documented for at least 6 months prior to enrollment.
",NULL,Comparison of percentage of responders by arm,Change from baseline for itch-related quality of life: ItchyQoL total score;Change from baseline for Prurigo Nodularis skin lesions;Change from baseline for sleep disturbance,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-08-07,2018-03-22,2018-03-22,360,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-12-22,TRUE,FALSE,TRUE
1377,NCT03488641,NA,NCT03488641,NCT: 2018-03-28 ICTRP: 2018-03-28 DRKS: NA,1,NA,NA,1,NA,NA,"criteria unclear or not available in register (""see section 3"")",NA,NA,NA,5,NA,NA,4,NA,no measure for response vs. Stable disease,NCT: Anticipated 80 ICTRP: 80 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no intervention,Abstract,https://doi.org/10.1182/blood-2019-125324,NA,2018-04-05,NA,2018-04-16,2023-03-31,Observational,Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer,Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer (SMARTrial),"Active, not recruiting",NA,80,Anticipated,German Cancer Research Center,Rate of completed drug sensitivity testing,Accuracy of patients' drug response prediction by ex-vivo drug profiling;Prediction of time to next treatment,SMART,Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer,Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer (SMARTrial),,,Observational,,,2018-03-28,2018-04-16,80,"Active, not recruiting",German Cancer Research Center,University Hospital Heidelberg,germany,Diagnostic Test: ex-vivo drug response assay,"
Inclusion Criteria:
1. Diagnosis of a hematological malignancy: patients with leukemia, myeloma or lymphoma
(e.g. ALL, AML, CLL, T-PLL, MCL, MM) who are in need of treatment and are willing to
donate sufficient tumor material for ex-vivo drug sensitivity testing.
2. The treating physician needs to indicate treatment.
3. Measurable disease burden according to criteria as mention in section 3.
4. Treatment must be scheduled and the patient must be eligible for the planed treatment
as judged by the treating physician.
5. Availability of 5x10e7 cells from peripheral blood draws, bone marrow aspirations or
lymph node biopsies.
6. Patient's written informed consent present.
7. Ability to understand the nature of the trial and the trial related procedures and to
comply with them.
Exclusion Criteria:
1. Any condition, which precludes initiation of treatment (e.g. breast feeding,
pregnancy, infections, etc.) as judged by the treating physician.
2. Any coexisting medical or psychological condition that would preclude participation in
the required study procedures, as judged by the treating physician.
3. No systemic cancer treatment except for cytoreductive pretreatment within 1 week of
enrollment.
",NULL,Rate of completed drug sensitivity testing,Accuracy of patients' drug response prediction by ex-vivo drug profiling;Prediction of time to next treatment,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-04-16,2018-03-28,2018-03-28,80,Observational,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,NA,TRUE,2018,2020-07-23,TRUE,FALSE,FALSE
1429,NCT03469609,NA,NCT03469609,NCT: 2018-02-28 ICTRP: 2018-02-28 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,Description deemed sufficient,4,NA,no AM,4,NA,no AM,NCT: Anticipated 106 ICTRP: 106 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-03-19,NA,2018-06-18,2022-04-30,Interventional,Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUC-FIRE Trial),A Randomized Multicenter Open-label Controlled Trial to Show That Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUCous FIstula REfeeding (MUC-FIRE) Trial),Recruiting,N/A,106,Anticipated,University of Leipzig,Time to full enteral feeds (hours),Time to first bowel movement;Thriving;Z-Score (standard deviation score);Number of days of postoperative total parenteral nutrition (TPN);Laboratory parameter indicating cholestasis;Assessment of adverse events (AEs);Assessment of serious adverse events (SAEs);Postoperative weight gain (g/d);Central venous line (CVL);hospitalisation;jump in caliber;Sodium resorption;Status of liver enzymes;Laboratory parameters,MUC-FIRE,Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUC-FIRE Trial),A Randomized Multicenter Open-label Controlled Trial to Show That Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUCous FIstula REfeeding (MUC-FIRE) Trial),;;muc-fire-leipzig@medizin.uni-leipzig.de,;;muc-fire-leipzig@medizin.uni-leipzig.de,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2018-02-28,2018-06-18,106,Recruiting,University of Leipzig,German Research Foundation,austria;germany;austria;germany,Other: mucous fistula refeeding,"
Inclusion Criteria:
1. Infants < 366 days,
2. Ileostomy / Jejunostomy,
3. double loop enterostomies and split enterostomies (with mucous fistula)
4. Signed written informed consent obtained by parents/legal guardians and willingness of
parents/legal guardians to comply with treatment and follow-up procedures of their
child
Exclusion Criteria:
1. resection of ileocecal valve,
2. colostomy,
3. small bowel atresia,
4. multiple ostomies (more than just an enterostomy and a mucous fistula),
5. chromosomal abnormalities (if known at the time of randomization),
6. Hirschsprung's disease,
7. participation in another drug-intervention study
8. Intestinal perforation due to a hemodynamic heart defect
",NULL,Time to full enteral feeds (hours),Time to first bowel movement;Thriving;Z-Score (standard deviation score);Number of days of postoperative total parenteral nutrition (TPN);Laboratory parameter indicating cholestasis;Assessment of adverse events (AEs);Assessment of serious adverse events (SAEs);Postoperative weight gain (g/d);Central venous line (CVL);hospitalisation;jump in caliber;Sodium resorption;Status of liver enzymes;Laboratory parameters,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-06-18,2018-02-28,2018-02-28,106,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,2020-11-19,TRUE,FALSE,FALSE
1488,NCT03447938,NA,NCT03447938,NCT: 2018-02-06 ICTRP: 2018-02-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,Description deemed sufficient,4,NA,no AM,4,NA,no AM,NCT: Anticipated 176 ICTRP: 176 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,Studienprotokoll,https://doi.org/10.1016/j.cct.2019.01.006,NA,2018-02-27,NA,2018-09-01,2025-03-01,Interventional,The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial,The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial,Recruiting,N/A,176,Anticipated,Ottawa Heart Institute Research Corporation,Quality of life - physical function,Percentage of arterial grafts;Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR);Number of bypass grafts;Intra-operative transfusion;Post-operative transfusion;Re-exploration for bleeding;Post-operative pain;Duration of intubation;Length of ICU stay;Length of hospital stay;Atrial fibrillation;Wound infection;Angina;Quality of Life - mental function,20180008,The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Trial,The Minimally Invasive Coronary Surgery Compared to STernotomy Coronary Artery Bypass Grafting Randomized Controlled Trial,;scrowe@ottawaheart.ca,;scrowe@ottawaheart.ca,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). ,N/A,2018-02-06,2018-09-01,176,Recruiting,Ottawa Heart Institute Research Corporation,London Health Sciences Centre;Heart Center Leipzig - University Hospital;Fortis Escorts Heart Institute;The Methodist Hospital System;Carolinas Medical Center;Gundersen Lutheran Health System;Jilin Heart Hospital;Far Eastern Memorial Hospital;Medtronic;Apollo Hospitals;Ichinomiya-Nishi Hospital;Fresno Heart and Surgical Hospital,united states;canada;china;germany;india;japan;taiwan;canada;china;germany;india;japan;taiwan;united states,Procedure: MICS CABG;Procedure: Conventional CABG,"
Inclusion Criteria:
- 18 years of age or older
- Angiographically-confirmed multi-vessel coronary artery disease lesions with >=70% in
at least 2 major epicardial vessels in 2 or more coronary artery territories (left
anterior descending (LAD), circumflex (CX) and right coronary artery (RCA)) OR lesions
>=50% in the left main (LM)
- Patients who, in the opinion of the investigator, are amenable for coronary surgery
through either median sternotomy or minimally-invasive approach.
- Patients who are willing and able to comply with all follow-up study visits.
Exclusion Criteria:
- <18 years of age
- concomitant cardiac procedure with CABG (e.g. valve repair or replacement)
- Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest
- Contra-indications for MICS CABG, including: severe pectus excavatum; severe pulmonary
disease; hemodynamically significant left subclavian stenosis; morbid obesity; severe
left ventricular (LV) dysfunction; no adequate PDA or marginal branch target; absence
of femoral pulse bilaterally.
- Contraindications for conventional CABG via sternotomy
- Concomitant life-threatening disease likely to limit life expectancy to <2 years
- Emergency CABG with hemodynamic compromise
- Inability to provide informed consent.
",NULL,Quality of life - physical function,Quality of Life - mental function;Angina;Wound infection;Atrial fibrillation;Length of hospital stay;Length of ICU stay;Duration of intubation;Post-operative pain;Re-exploration for bleeding;Post-operative transfusion;Intra-operative transfusion;Percentage of arterial grafts;Number of bypass grafts;Major Adverse Cardiac and Cerebrovascular Events (MACCE) and Target Vessel Revascularization (TVR),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-09-01,2018-02-06,2018-02-06,176,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,NA,TRUE,2018,2020-06-02,TRUE,FALSE,FALSE
1507,NCT03442946,NA,NCT03442946,NCT: 2018-02-15 ICTRP: 2018-02-15 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,4,NA,no AM,NA,NA,NA,NCT: Anticipated 500 ICTRP: 500 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no indication and outcome,kein Artikel,NA,NA,2018-02-22,NA,2018-03-01,2019-12-31,Observational,International Nutrition Survey 2018,International Nutrition Survey 2018,Recruiting,NA,500,Anticipated,RWTH Aachen University,Change in nutrition adequacy in the ICU,,3CARE_BOÄ_18-001,International Nutrition Survey 2018,International Nutrition Survey 2018,elaaf@ukaachen.de,elaaf@ukaachen.de,Observational,,,2018-02-15,2018-03-01,500,Recruiting,RWTH Aachen University,Clinical Evaluation Research Unit at Kingston General Hospital,"united states;canada;germany;iran, islamic republic of;russian federation;canada;germany;iran, islamic republic of;russian federation;united states",NULL,
Inclusion Criteria:
- Age = 18 years
- Patients undergoing cardiac surgery
- Mechanically ventilated within 48 hours of ICU admission
- Stay on ICU > 72 hours
Exclusion Criteria:
- None
,NULL,Change in nutrition adequacy in the ICU,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-03-01,2018-02-15,2018-02-15,500,Observational,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,2019-12-17,TRUE,FALSE,FALSE
1658,NCT03391804,NA,NCT03391804,NCT: 2018-01-02 ICTRP: 2018-01-02 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Anticipated 20 ICTRP: 20 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2018-01-05,NA,2018-07-17,2019-12-13,Interventional,Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia,Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia,Completed,Phase 2,15,Actual,Allena Pharmaceuticals,Change in plasma oxalate,Change in 24-hr urinary oxalate excretion,2017-003547-38;ALLN-177-206,Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia,Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia,,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2018-01-02,2018-07-17,15,Completed,Allena Pharmaceuticals,NULL,united states;germany;united kingdom;germany;united kingdom;united states,Drug: ALLN-177,"
Inclusion Criteria:
1. Signed a informed consent form or an assent
2. Aged 12 or older with body weight = 35kg
3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known
underlying enteric disorder associated with malabsorption (e.g., bariatric surgery,
Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
4. Urinary oxalate = 40mg/24h (normalized for body surface area in children) at Screening
in patients with eGFR >15 mL/min/1.73m2
5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening
6. In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening
7. Patients on dialysis, must be stable for greater than 3 months
Exclusion Criteria:
1. Unable or unwilling to discontinue Vitamin C supplementation
",NULL,Change in plasma oxalate,Change in 24-hr urinary oxalate excretion,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-07-17,2018-01-02,2018-01-02,15,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-12-29,TRUE,FALSE,TRUE
1694,NCT03380429,NA,NCT03380429,NCT: 2017-12-15 ICTRP: 2017-12-15 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 438 ICTRP: 438 DRKS: NA,528,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1183/13993003.03103-2020,2020-08-11,2017-12-21,NA,2018-01-31,2019-01-24,Interventional,A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects,"An Open Label, Randomised, Parallel Group Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Relvar/Breo ELLIPTA Therapy, in Asthmatic Subjects With Poor Control",Completed,Phase 4,437,Actual,GlaxoSmithKline,Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; (Cohort 1: Data on Maintenance Use Supplied to Participant and HCP andCohort 5: no Data Supplied to Participant or HCP),Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor;Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor;Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor;Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor;Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor;Change From Baseline in Asthma Control Test (ACT) Total Score;Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6;Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6;Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6,2017-002266-45;207040,A Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Maintenance Therapy in Poorly Controlled Asthmatic Subjects,"An Open Label, Randomised, Parallel Group Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Relvar/Breo ELLIPTA Therapy, in Asthmatic Subjects With Poor Control",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 4,2017-12-15,2018-01-31,437,Completed,GlaxoSmithKline,NULL,united states;canada;germany;italy;netherlands;spain;united kingdom;canada;germany;italy;netherlands;spain;united kingdom;united states,Drug: RELVAR/BREO;Drug: Salbutamol;Device: Smart phone app;Device: HCP Dashboard;Device: Sensors,"
Inclusion Criteria:
- Subjects aged 18 years or older, at the time of signing the informed consent.
- Subjects with documented physician diagnosis of asthma as their primary respiratory
disease.
- ACT score <20 at screening visit.
- Non-smokers (never smoked or not smoking for >6 months with <10 pack years history
(Pack years = [cigarettes per day smoked/20] multiplied by number of years smoked).
- Male or female subjects will be included. A female subject is eligible to participate
if she is not pregnant, not breastfeeding, and at least one of the following
conditions applies: (i) Not a woman of childbearing potential (WOCBP). (ii) A WOCBP
who agrees to follow the contraceptive guidance during the treatment period and for at
least 5 days] after the last dose of study treatment.
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the consent form and protocol.
- Subject understands and is willing, able, and likely to comply with study procedures
and restrictions.
- Subject must be able to read in a language supported by the smart phone app in their
region.
- Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3
months, cannot have changed dose in the month prior to screening and be able to change
to an equivalent dose of RELVAR/BREO for the duration of the study. Other background
asthma medication such as anti-leukotrienes and oral corticosteroids are permitted
provided the dose has been stable for 1 month prior to screening.
- Subject must be able to change to Salbutamol/Albuterol MDI rescue for the duration of
the study and judged capable of withholding albuterol/salbutamol for at least 6 hours
prior to study visits.
- Subject must have their own Android or iPhone operating system (IOS) smart phone and a
data package suitable for the installation and running of the app and sending and
receiving data. Data used by the CIS is approximately 1 megabyte (MB) per month as a
maximum; this is less data than a 1 minute video streamed from YouTube (2MB).
- Subjects must be willing and able to download the app on their personal smart phone
and keep it turned on for the duration of the study. This will also require Bluetooth
to be turned on for duration of the study. Subjects will also have to turn on mobile
data for the app for the duration of study; unless travelling and when extra data
roaming costs could be incurred.
Inclusion criteria for randomization:
- ACT score <20 at randomization visit (visit 2).
Exclusion Criteria:
- Subjects with a known or suspected alcohol or drug abuse which in the opinion of the
investigator could interfere with the subject's proper completion of the protocol
requirement.
- History of life threatening asthma: Defined as an asthma episode that required
intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic
seizures within the last 6 months.
- A lower respiratory tract infection within 7 days of the screening visit.
- Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other
respiratory disorders including active tuberculosis, lung cancer, bronchiectasis,
sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or
other active pulmonary diseases.
- History of hypersensitivity/intolerance to any components of the study inhalers
(example, lactose, magnesium stearate). In addition, subjects with a history of severe
milk protein allergy that, in the opinion of the study physician, contraindicates
participation will also be excluded.
- Historical or current evidence of clinically significant or rapidly progressing or
unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic,
immunological, endocrine (including uncontrolled diabetes or thyroid disease) or
hematological abnormalities that are uncontrolled. Significant is defined as any
disease that, in the opinion of the investigator, would put the safety of the subject
at risk through participation, or which would affect the analysis if the
disease/condition exacerbated during the study.
- Subjects who have ever received treatment with biological based therapy example,
omalizumab, mepolizumab, for asthma.
- Subjects who have received an investigational drug and/or medical device within 30
days of entry into this study (Screening), or within five drug half-lives of the
investigational drug, whichever is longer.
- A subject will not be eligible for this study if he/she is an immediate family member
of the participating investigator, sub-investigator, study coordinator, employee of
the participating investigator, or any family member of a Propeller Health employee.
",NULL,Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; (Cohort 1: Data on Maintenance Use Supplied to Participant and HCP andCohort 5: no Data Supplied to Participant or HCP),Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor;Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor;Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor;Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor;Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor;Change From Baseline in Asthma Control Test (ACT) Total Score;Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6;Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6;Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-01-31,2017-12-15,2017-12-15,437,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-01-23,TRUE,FALSE,TRUE
1735,NCT03365193,NA,NCT03365193,NCT: 2017-12-01 ICTRP: 2017-12-01 DRKS: NA,0,NA,"Is this interventional because patients are (all) assigned to a diagnostic test, which is then evaluated? Also, an intervention (the test) is specified.",1,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure (criteria for IE, Duke criteria?)",NA,NA,NA,NCT: Actual 263 ICTRP: 263 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-12-07,NA,2017-12-01,2020-05-30,Observational,PRetest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities (PRO ENDOCARDITIS ECHO-Study),Retest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities,"Active, not recruiting",NA,263,Actual,"University Hospital, Essen",Infective Endocarditis,Presence of signs of infective endocarditis on transesophageal echocardiography as defined by judgement of the examining physician.,17-7747-BO,PRetest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities (PRO ENDOCARDITIS ECHO-Study),Retest prObability of Infectious ENDOCARDITIS for Appropriate Criteria Regarding Transesophageal ECHOcardiography in Tertiary Care Facilities,NULL,NULL,Observational,,,2017-12-01,2017-12-01,263,"Active, not recruiting","University Hospital, Essen",NULL,germany,Diagnostic Test: Transesophageal Echocardiography,
Inclusion Criteria:
- patients referred for echocardiographic assessment of suspected endocarditis
Exclusion Criteria:
- Unwillingness to participate.
,NULL,Infective Endocarditis,Presence of signs of infective endocarditis on transesophageal echocardiography as defined by judgement of the examining physician.,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-12-01,2017-12-01,2017-12-01,263,Observational,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2017,2020-04-14,TRUE,FALSE,FALSE
1742,NCT03362047,NA,NCT03362047,NCT: 2017-11-22 ICTRP: 2017-11-22 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage,3,NA,"no AM, no measure of function",4,NA,no AM,NCT: Anticipated 30 ICTRP: 30 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-12-05,NA,2018-03-01,2022-06-30,Interventional,(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment),Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen,Recruiting,Phase 2,30,Anticipated,University of Giessen,RV function,recruitability;feasibility to set up a larger phase II study;RV contractility;Collection of Adverse Events,2015-002835-17;250774,(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment),Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen,;Khodr.Tello@innere.med.uni-giessen.de,;Khodr.Tello@innere.med.uni-giessen.de,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2017-11-22,2018-03-01,30,Recruiting,University of Giessen,Philipps University Marburg Medical Center,germany,Drug: Riciguat Group;Drug: Macitentan Group,"
Inclusion Criteria:
- Female and male patients, 18 years = age = 85 years
- Diagnosis of Pulmonary Hypertension Group 1 according to Nizza Definition (PAH)
confirmed by invasive methods, WHO functional class II and III
- Existing clinical need to repeat a right ventricular catheter examination (as
recommended by the current Kölner Konsensuskonferenz)
- Ability to understand study goals and agree to study participation
- Hemodynamic criteria of ventricular catheter examination:
- Pulmonary vascular resistance (PVR)> 240 dyn x sec x cm-5
- Mean Pulmonary Arterial Pressure (mPAP) = 25 mmHg
- Clinical need to receive treatment with a drug approved for the treatment of PAH for
the first time
- Potentially fertile women must agree to use highly effective methods of contraception,
either through abstinence or the use of at least two methods of contraception from the
date of consent until one month after the end of the study. An effective pregnancy
protection consists in the combination of a hormonal contraceptive (oral, injectable
or implant) and a barrier method (condom or diaphragm with a vaginal spermicide)
- Written consent to the clinical trial
Exclusion Criteria:
Existing therapy with positive inotropic drugs such as Catecholamines (including
norepinephrine, dobutamine, suprarenin)
- Pregnancy or breastfeeding
- General contraindication for examinations to be performed during the study
- Hypersensitivity to the active substances or to a constituent of the study medication
(in particular lactose and soya)
- Simultaneous participation in another medical therapy study
- Simultaneous participation in another non-drug study that would preclude participation
in this study
- Participation within one month after completing another therapy study
- Heavy liver function disorders
- Existing increase in liver aminotransferases (aspartate aminotransferase (AST) and /
or alanine aminotransferase (ALT))> 3 × ULN
- Systolic blood pressure <95 mmHg
- Pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP)
- anemia (Hb <10 g / dl)
- Concomitant medication with potential interaction to macitentan and/or riociguat
according to the IB
- Severe kidney dysfunction
- Severe hemoptysis
- History of bronchial artery embolization
- smoker
",NULL,RV function,recruitability;feasibility to set up a larger phase II study;RV contractility;Collection of Adverse Events,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-03-01,2017-11-22,2017-11-22,30,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,2020-11-06,TRUE,FALSE,TRUE
1758,NCT03358472,NA,NCT03358472,NCT: 2017-11-27 ICTRP: 2017-11-27 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage,5,NA,NA,5,NA,NA,NCT: Actual 89 ICTRP: 89 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Abstract,10.1200/JCO.2018.36.15_suppl.TPS6090,NA,2017-11-30,NA,2017-12-01,2021-07-31,Interventional,"Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)","A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)","Active, not recruiting",Phase 3,89,Actual,Incyte Corporation,"Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen",Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs);Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs,KEYNOTE-669/ECHO 304,"Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)","A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First Line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2017-11-27,2017-12-01,89,"Active, not recruiting",Incyte Corporation,Merck Sharp & Dohme Corp.,"united states;australia;austria;canada;hungary;italy;japan;korea, republic of;poland;portugal;spain;taiwan;turkey;united kingdom;australia;austria;canada;hungary;italy;japan;korea, republic of;poland;portugal;spain;taiwan;turkey;united kingdom;united states;brazil;france;germany;mexico",Drug: Pembrolizumab;Drug: Epacadostat;Drug: Cetuximab;Drug: Cisplatin;Drug: Carboplatin;Drug: 5-Fluorouracil,"
Inclusion Criteria:
- Measurable disease based on RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function per protocol-defined criteria.
- Documentation of results from testing of human papilloma virus (HPV) status for
oropharyngeal cancer.
- Baseline archival tumor specimen available or willing to undergo a prestudy treatment
tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain
the specimen.
Exclusion Criteria:
- Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous
histologies as primary tumors.
- Disease progression within 6 months of completion of curatively intended systemic
treatment for locoregionally advanced HNSCC.
- Use of protocol-defined prior/concomitant therapy.
- Known additional malignancy that is progressing or has required active treatment
within the past 3 years.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment in past 2 years.
- Known history of human immunodeficiency virus (HIV) infection. HIV testing is not
required unless mandated by local health authority.
- Known history of or is positive for active hepatitis B (defined as hepatitis B surface
antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is
detected).
",NULL,"Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen",Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs);Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-12-01,2017-11-27,2017-11-27,89,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2020-08-26,TRUE,FALSE,FALSE
1782,NCT03353350,NA,NCT03353350,NCT: 2017-11-21 ICTRP: 2017-11-21 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,3,NA,NA,3,NA,NA,NCT: Actual 386 ICTRP: 386 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,NA,NA,Poster,https://doi.org/10.1111/1753-0407.12637,NA,2017-11-27,NA,2017-12-05,2020-09-07,Interventional,Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise,"A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise",Completed,Phase 3,406,Actual,Sanofi,Change in glycated hemoglobin (HbA1c) (%),Change in HbA1c (%);Change in fasting plasma glucose (FPG);HbA1c <7%;Change in body weight;Hypoglycemic participants;Hypoglycemic events;Adverse Events (AEs),2016-001857-42;U1111-1182-1806;EFC14822,Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise,"A 56-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2017-11-21,2017-12-05,406,Completed,Sanofi,NULL,united states;germany;poland;ukraine;united kingdom;germany;poland;ukraine;united kingdom;united states,Drug: efpeglenatide (SAR439977);Drug: placebo,"
Inclusion criteria:
- Participants must be at least 18 years of age at the time of signing the informed
consent.
- Participants with T2DM, and treated with diet and exercise.
- Hemoglobin A1c between 7.0% and 10.0% (inclusive) measured by the central laboratory
at Screening.
Exclusion criteria:
- Clinically relevant history of gastrointestinal disease associated with prolonged
nausea and vomiting, including (but not limited to) gastroparesis, unstable and not
controlled gastroesophageal reflux disease within 6 months prior to Screening or
history of surgery affecting gastric emptying.
- History of pancreatitis (unless pancreatitis was related to gallstone and
cholecystectomy has been performed) and pancreatitis during previous treatment with
incretin therapies, chronic pancreatitis, and pancreatectomy.
- Personal or family history of Medullary Thyroidian Cancer (MTC) or genetic conditions
that predisposes to MTC (eg multiple endocrine neoplasia syndromes).
- Retinopathy or maculopathy with one of the following treatments, either recent (within
3 months of screening) or planned: intravitreal injections or laser or vitrectomy
surgery.
- Body weight change of =5 kg within the last 3 months prior to Screening.
- Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at
Randomization.
- End-stage renal disease as defined by estimated glomerular filtration rate (eGFR , by
Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.
- Laboratory findings at the Screening Visit:
- Alanine aminotransferase (ALT ) or aspartate aminotransferase (AST ) >3 times the
upper limit of the normal (ULN ) or total bilirubin >1.5 times the ULN (except in case
of documented Gilbert's syndrome).
- Amylase and/or lipase: >3 times the ULN laboratory range.
- Calcitonin =5.9 pmol/L (20 pg/mL).
- Gastric surgery or other gastric procedures intended for weight loss within 2 years
prior to Screening, or planned during study period.
- History of drug or alcohol abuse within 6 months prior to the time of Screening.
- Pregnant (demonstrated by serum pregnancy test at Screening) or breast-feeding women.
- Women of childbearing potential not willing to use highly effective method(s) of birth
control during the study period and for at least 5 weeks after the last dose of study
intervention.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
",NULL,Change in glycated hemoglobin (HbA1c) (%),Change in HbA1c (%);Change in fasting plasma glucose (FPG);HbA1c <7%;Change in body weight;Hypoglycemic participants;Hypoglycemic events;Adverse Events (AEs),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-12-05,2017-11-21,2017-11-21,406,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2020-09-14,TRUE,FALSE,TRUE
1826,NCT03340766,NA,NCT03340766,NCT: 2017-10-23 ICTRP: 2017-10-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Anticipated 66 ICTRP: 66 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-11-14,NA,2018-03-16,2026-03-26,Interventional,Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab (KEYNOTE-348),A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (KEYNOTE-348),Recruiting,Phase 1,70,Anticipated,Amgen,Incidence of dose limiting toxicities (DLTs),Objective Response;Progression Free Survival;Overall Survival;Duration of response;Blinatumomab Steady state concentration;Blinatumomab Clearance rate;Pembrolizumab Peak Plasma Concentration;Pembrolizumab Minimum plasma concentration;Pembrolizumab PK Parameter - AUC;Complete response,2016-002191-27;20150290,Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab (KEYNOTE-348),A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (KEYNOTE-348),;medinfo@amgen.com,;medinfo@amgen.com,Interventional,Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1,2017-10-23,2018-03-16,70,Recruiting,Amgen,Merck Sharp & Dohme Corp.,united states;australia;france;germany;netherlands;spain;australia;france;germany;netherlands;spain;united states,Drug: Blinatumomab;Drug: Pembrolizumab,"
Inclusion Criteria:
- Have histologically confirmed Diffuse Large B-Cell Lymphoma that is either:
- Refractory after at least one regimen of systemic chemotherapy and/or targeted
therapy, or
- In first or later relapse if have received at least 2 systemic regimens since time of
diagnosis, or
- Relapsed post-autologous or allogeneic HSCT with adequate organ function after
proximity to transplantation time exclusions as specified in Exclusion Criteria 208
and 209
- Have measureable disease
- Eastern Cooperative Oncology Group (ECOG) performance status = 2
- Life expectancy of = 12 weeks in the opinion of the Investigator
- Biopsy proven DLBCL (biopsy proven at least at primary diagnosis of DLBCL)
Other Inclusion Criteria May Apply
Exclusion Criteria:
- Richter's transformation (DLBCL arising in the setting of prior chronic lymphocytic
leukemia) or Primary Mediastinal B cell Lymphoma (PMBCL)
- History or presence of clinically relevant Central Nervous System pathology such as
epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's
disease, cerebellar disease, organic brain syndrome, or psychosis.
- Has a diagnosis of immunodeficiency or has received systemic steroid therapy (in
excess of 10 mg daily of prednisone equivalent) or any other form of immunosuppressive
therapy within 7 days prior to the first dose of protocol specified therapy.
- Has undergone prior allogeneic HSCT:
- within the last 5 years OR
- greater than 5 years ago but has active graft versus host disease (GvHD) requiring
systemic treatment.
- Has received autologous HSCT within 6 weeks prior to start of treatment.
Other Exclusion Criteria May Apply.
",NULL,Incidence of dose limiting toxicities (DLTs),Objective Response;Progression Free Survival;Overall Survival;Duration of response;Blinatumomab Steady state concentration;Blinatumomab Clearance rate;Pembrolizumab Peak Plasma Concentration;Pembrolizumab Minimum plasma concentration;Pembrolizumab PK Parameter - AUC;Complete response,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-03-16,2017-10-23,2017-10-23,70,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-12-08,TRUE,FALSE,FALSE
1852,NCT03333018,NA,NCT03333018,NCT: 2017-10-06 ICTRP: 2017-10-06 DRKS: NA,1,1,NA,2,1,NA,NA,NA,NA,NA,5,1,NA,3,1,NA,NCT: Actual 22155 ICTRP: 22155 DRKS: NA,54791,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.rmed.2019.04.018,2019-04-26,2017-11-06,NA,2015-07-06,2017-02-28,Observational,A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination),Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2),Completed,NA,22155,Actual,AstraZeneca,Baseline age of new users;Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis;Baseline frequency of new users with severe COPD;Baseline frequency of new users with a history of cardiovascular disease;Overall comorbidity index of new users;Frequency of respiratory medication use by new users;Baseline gender of new users;Frequency of users of aclidinium bromide with comorbid asthma diagnoses or in the absence of other drugs or diagnoses suggestive of COPD;Frequency of pregnancies during use of COPD medication;Frequency of use of aclidinium bromide in the pediatric population;Frequency of comorbid conditions in the paediatric population;Baseline frequency of patients with renal or hepatic impairment;Baseline frequency of patients who have experienced a recent exacerbation;Baseline frequency of patients with thyrotoxicosis or pheochromocytoma;Frequency of previous smoking in new users;Frequency of current smokers in new users;Frequency of new users with BMI <18.50 kg/m2 (underweight);Frequency of new users with BMI ranging from 18.50 to 24.99 kg/m2 (normal weight);Frequency of new users with BMI >25.0 kg/m2 (overweight);Frequency of new users with BMI ranging between 25.0 and 29.99 kg/m2 (pre-obese);Frequency of new users with BMI >30 kg/m2 (obese);Frequency of new users with low socioeconomic status (Townsend multiple deprivation index);Baseline frequency of patients with benign prostatic hyperplasia;Baseline frequency of patients with bladder neck obstruction;Baseline frequency of patients with urinary retention;Baseline frequency of patients with narrow-angle glaucoma,Duration of COPD medication use;Average daily dose of COPD medication;Adherence to COPD medication within 1 year;Frequency of use of concomitant medications;Frequency of switching between COPD medications;Total number of prescriptions,EUPAS6559;D6560R00005,A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination),Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2),;,;,Observational,,,2017-10-06,2015-07-06,22155,Completed,AstraZeneca,RTI Health Solutions,denmark;germany;united kingdom;denmark;germany;united kingdom,Drug: Aclidinium bromide;Drug: Aclidinium bromide/formoterol;Drug: Other COPD medication,"
Inclusion Criteria:
- Patients in the study will be required to meet the following criteria, as ascertained
from each of the automated databases:
- To have at least 1 year of enrolment in the database (DUS1 and DUS2).
- To have not been prescribed aclidinium bromide as monotherapy or with concomitant use
of formoterol during the 6 months before the date of first prescription of aclidinium
bromide (index date) in DUS1
- To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of
formoterol, or as aclidinium/formoterol during the 6 months before the date of first
prescription of aclidinium bromide (index date) in DUS2
The same inclusion criteria will be applied for each of the comparator drugs.
Exclusion Criteria:
- No age restrictions or exclusion criteria will be applied. This will allow for the
characterisation of all users of aclidinium bromide and comparator drugs irrespective
of the indication for which these medications are used. Identification of potential
off-label use of aclidinium bromide in the paediatric and adult populations is one of
the specific objectives of this DUS.
",NULL,Baseline age of new users;Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis;Baseline frequency of new users with severe COPD;Baseline frequency of new users with a history of cardiovascular disease;Overall comorbidity index of new users;Frequency of respiratory medication use by new users;Baseline gender of new users;Frequency of users of aclidinium bromide with comorbid asthma diagnoses or in the absence of other drugs or diagnoses suggestive of COPD;Frequency of pregnancies during use of COPD medication;Frequency of use of aclidinium bromide in the pediatric population;Frequency of comorbid conditions in the paediatric population;Baseline frequency of patients with narrow-angle glaucoma;Baseline frequency of patients with urinary retention;Baseline frequency of patients with bladder neck obstruction;Baseline frequency of patients with benign prostatic hyperplasia;Frequency of new users with low socioeconomic status (Townsend multiple deprivation index);Frequency of new users with BMI >30 kg/m2 (obese);Frequency of new users with BMI ranging between 25.0 and 29.99 kg/m2 (pre-obese);Frequency of new users with BMI >25.0 kg/m2 (overweight);Frequency of new users with BMI ranging from 18.50 to 24.99 kg/m2 (normal weight);Frequency of new users with BMI <18.50 kg/m2 (underweight);Frequency of current smokers in new users;Frequency of previous smoking in new users;Baseline frequency of patients with thyrotoxicosis or pheochromocytoma;Baseline frequency of patients who have experienced a recent exacerbation;Baseline frequency of patients with renal or hepatic impairment,Total number of prescriptions;Frequency of switching between COPD medications;Frequency of use of concomitant medications;Adherence to COPD medication within 1 year;Average daily dose of COPD medication;Duration of COPD medication use,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-07-06,2017-10-06,2017-10-06,22155,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2015,2018-02-20,TRUE,FALSE,FALSE
1969,NCT03297983,NA,NCT03297983,NCT: 2017-09-27 ICTRP: 2017-09-27 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dose range,5,NA,NA,5,NA,NA,NCT: Actual 18 ICTRP: 18 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-09-29,NA,2017-10-09,2017-12-06,Interventional,M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule,"Phase I, Open-label, Randomized, Two Part, Three-Period, Two-Sequence, Cross-over Study to Investigate the Relative Bioavailability of a Tablet Formulation Compared to Powder-in-Capsule of M7583 Including a Food Effect Evaluation for the Tablet in Healthy Volunteers",Completed,Phase 1,18,Actual,"Merck KGaA, Darmstadt, Germany",Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concnetration (AUC0-t) of M7583;Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of M7583;Maximum Observed Drug Concentration (Cmax) of M7583,"Percentage of AUC0-∞ Obtained by Extrapolation (%AUCextra) of M7583;Occurrence of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs;Occurrence of Subjects With TEAEs by Severity According to Qualitative Toxicity Scale Selected From National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.03;Number of Subjects with Clinically Significant Change From Baseline in Laboratory Tests, Vital Sign and 12-lead Electrocardiogram (ECG) Findings;Time to Reach the Maximum Plasma Concentration (tmax) of M7583;Terminal Rate Constant (λz) of M7583;Apparent Terminal Half-life (t1/2) of M7583;Total Body Clearance of Drug From Plasma Following Oral Administration (CL/f) of M7583;Apparent Volume of Distribution (Vz/f) of M7583;Area Under the M7583 Plasma Concentration-time Curve From Time Zero to 24 hours After Dosing (AUC0-24h);Relative Bioavailability of M7583 Tablet versus M7583 PIC (Frel,T/P);Relative Bioavailability of M7583 Tablet Administered 30 Minutes After a Standard Breakfast Versus Tablet Administered After an Overnight Fast (Frel,Fed/Fasted)",2017-001674-41;MS200662-0017,M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule,"Phase I, Open-label, Randomized, Two Part, Three-Period, Two-Sequence, Cross-over Study to Investigate the Relative Bioavailability of a Tablet Formulation Compared to Powder-in-Capsule of M7583 Including a Food Effect Evaluation for the Tablet in Healthy Volunteers",,,Interventional,Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label). ,Phase 1,2017-09-27,2017-10-09,18,Completed,"Merck KGaA, Darmstadt, Germany",NULL,germany,Drug: M7583,"
Inclusion Criteria:
- Adult males and females between 18 and 55 years of age (inclusive) with total body
weight between 50.0 and 100.0 kilogram (kg) (inclusive) and body mass index (BMI)
between 19.0 and 30.0 kilogram per meter square (kg/m2) (inclusive) at the time of the
Screening examination.
- A female participant is eligible to participate if she is not pregnant, not
breastfeeding.
- Females must have a negative serum pregnancy test at Screening visit and at Day -1
before randomization/first dosing.
- Men must agree to use a barrier method (specifically, male condom with or without
spermicide) and to have their female partners use a highly effective method of
contraception during the treatment period, and for at least 3 months after the last
IMP administration. Men must also refrain from donating sperm during this period.
- Healthy as assessed by the Investigator with no clinically significant abnormality
identified on physical examination or laboratory evaluation and no active clinically
significant disorder, condition, infection or disease that would pose a risk to
subject safety or interfere with the trial evaluation, procedures, or completion.
- Stable non-smokers for at least 3 months preceding Screening.
- Must agree not to consume any alcohol during the treatment period of the trial.
- Able and willing to give written informed consent and has signed the appropriate
written informed consent form, approved by the Investigator's Independent Ethics
Committee (IEC), prior to the performance of any trial activities.
Exclusion Criteria:
- History of clinically relevant disease of any organ system, that may interfere with
the objectives of the trial or provide a risk to the health of the subject.
- History of chronic or recurrent acute infection or any bacterial, viral, parasitic or
fungal infections within 30 days prior to Screening and at any time between Screening
and admission, or hospitalization due to infection within 6 months prior to Screening.
- History of Herpes zoster within 12 months prior to Screening
- History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity
to the active drug substance and/or formulation ingredients; history of serious
allergic reactions leading to hospitalization or any other hypersensitivity reaction
in general, which may affect the safety of the subject and/or outcome of the trial per
the Investigator's discretion.
- History of alcoholism or drug abuse within 2 years prior to Screening and the subject
is unwilling to abstain from alcohol and drug of abuse during the trial
- Consumption of an average weekly intake of greater than (>) 14 drinks/week for males
or > 7 drinks/week for females. One drink is equivalent to (12 g alcohol) = 5 ounces
(150 milliliter (mL)) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of
40 Vol% distilled spirits.
- Positive for drugs of abuse, nicotine/cotinine or alcohol at Screening or at
admission.
- Supine systolic blood pressure > 140 mmHg or less than (<) 90 mmHg, diastolic blood
pressure > 90 mmHg or <50 and pulse rate >100 or = 50 bpm, at admission.
- 12-Lead ECG showing a QTcF > 450 ms, PQ > 200ms, or QRS > 120 ms or other clinically
relevant abnormal findings
",NULL,Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concnetration (AUC0-t) of M7583;Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-8) of M7583;Maximum Observed Drug Concentration (Cmax) of M7583,"Occurrence of Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs;Occurrence of Subjects With TEAEs by Severity According to Qualitative Toxicity Scale Selected From National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.03;Number of Subjects with Clinically Significant Change From Baseline in Laboratory Tests, Vital Sign and 12-lead Electrocardiogram (ECG) Findings;Time to Reach the Maximum Plasma Concentration (tmax) of M7583;Terminal Rate Constant (?z) of M7583;Apparent Terminal Half-life (t1/2) of M7583;Total Body Clearance of Drug From Plasma Following Oral Administration (CL/f) of M7583;Apparent Volume of Distribution (Vz/f) of M7583;Area Under the M7583 Plasma Concentration-time Curve From Time Zero to 24 hours After Dosing (AUC0-24h);Percentage of AUC0-8 Obtained by Extrapolation (%AUCextra) of M7583;Relative Bioavailability of M7583 Tablet versus M7583 PIC (Frel,T/P);Relative Bioavailability of M7583 Tablet Administered 30 Minutes After a Standard Breakfast Versus Tablet Administered After an Overnight Fast (Frel,Fed/Fasted)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-10-09,2017-09-27,2017-09-27,18,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2018-07-20,TRUE,FALSE,FALSE
2052,NCT03273127,NA,NCT03273127,NCT: 2017-09-04 ICTRP: 2017-09-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 12 ICTRP: 12 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,2,NA,kein Artikel,NA,NA,2017-09-06,NA,2017-09-21,2017-11-09,Interventional,"To Assess the Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids","A Phase 1, Randomized, Single-Blind, Placebo Controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids",Completed,Phase 1,12,Actual,AstraZeneca,"Observed maximum plasma concentration (Cmax) assessment for abediterol on Day 1;Time to reach maximum plasma concentration (tmax) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 1;Observed maximum concentration (Cmax) assessment for abediterol on Day 9;Time to reach maximum concentration (tmax) assessment for abediterol on Day 9;Terminal rate constant, estimated by log-linear LS regression of the terminal part of the concentration-time curve (λz) assessment for abediterol on Day 9;Terminal half-life, estimated as (ln2)/λz (t½λz) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 9;Apparent clearance for drug estimated as dose divided by AUC0-24 (CL/F) assessment for abediterol on Day 9;Average plasma concentration during a dosing interval, estimated as AUC0-24/24 (Cavg) assessment for abediterol on Day 9;Fluctuation index during a dosing interval estimated as 100*(Cmax - Cmin)/Cavg (%), where Cmin is the minimum concentration at the end of the dosing interval (%Fluctuation) assessment for abediterol on Day 9;Accumulation ratio for Cmax estimated as (Cmax on Day 9/Cmax on Day 1) (Rac (Cmax)) assessment for abediterol on Day 9;Accumulation ratio for AUC0-24 estimated as (AUC0-24 on Day 9/AUC0-24 on Day 1) (Rac (AUC0-24)) assessment for abediterol on Day 9;Vital sign (Blood pressure [BP]);Vital sign (pulse);12-lead Electrocardiograms (ECGs) including high precision QTc analysis and telemetry;Clinical laboratory assessments (hematology, clinical chemistry and urinalysis);Number of patients with Adverse Events (AEs)",,D6540C00006,"To Assess the Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids","A Phase 1, Randomized, Single-Blind, Placebo Controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Abediterol Administered Once Daily for 9 Days, in Patients With Asthma on Inhaled Corticosteroids",;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). ,Phase 1,2017-09-04,2017-09-21,12,Completed,AstraZeneca,NULL,germany;germany;germany;germany;germany,Drug: Abediterol;Drug: Placebo;Drug: Abediterol;Drug: Placebo;Drug: Abediterol;Drug: Placebo;Drug: Abediterol;Drug: Placebo,"
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific
procedures.
- Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma
and with suitable veins for cannulation or repeated venipuncture.
- Non-smoker or former smoker who quit = 6 months prior to Visit 1 and have a total
smoking history of = 10 pack-years. Note: Pack-years are calculated by dividing the
number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and
multiplying this figure by the number of years a person has been smoking. For example,
a person who smokes 40 cigarettes a day and has been smoking for 10 years would have a
20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 ×
10 years of smoking = 20 pack-year history).
- Patient with documented clinical diagnosis of asthma for = 6 months before Visit 1
according to Global Initiative for Asthma (GINA) guidelines.
- Patient with blood pressure (defined as systolic blood pressure [SBP] = 90 and = 140
mmHg, and diastolic blood pressure [DBP] = 50 and = 90 mmHg) at Screening, measured
after resting in the supine position for 5 minutes.
- Patient with no relevant clinical laboratory findings at Screening (Visits 1 or 2) as
judged by the Investigator.
- Patient on stable dose of ICSs for at least 1 month prior to Visit 1. Patients on
bronchodilators will need to do appropriate wash-out prior to the pulmonary function
test at Visit 2.
- Patient with pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Visit 2
= 40% and = 90% of predicted (mean of 2 pre-bronchodilator measurements taken 30
minutes apart).
- Patient who demonstrates the ability to use the study inhalation device properly.
Patient able to perform acceptable pulmonary function testing for FEV1 according to
American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria.
- Negative pregnancy test (serum pregnancy test at Screening) for female patients.
- Female patients must be post-menopausal, surgically sterile, or must be able to
adhere to the conditions of contraceptive requirements. Male patients must be
surgically sterile or must be able to adhere to the conditions of contraceptive
requirements.
- Patients willing not to donate blood during the study and for 3 months following their
last dose of IMP.
- Patient willing and able to follow study directions and restrictions.
- Patient must be able to read, speak and understand German language.
Exclusion Criteria:
- Patient has known or suspected hypersensitivity to the IMP or excipients, including
lactose (Note: lactose intolerance is not an exclusion criterion).
- Patient who has used systemic steroid in the 6 weeks before Visit 1.
- Patient with a history of hospitalization due to asthma in the 6 months prior to Visit
1 or a history of intubation because of asthma at any time in their lifetime.
- Patient with any active pulmonary disease other than asthma.
- Patient non-compliant with study procedures in the Screening period (prior to
randomization) -as judged by the Investigator.
- Patient under treatment with biologicals such as monoclonal antibodies or chimeric
biomolecules including omalizumab, mepolizumab, and reslizumab within 6 months or 5
half-lives before Visit 1, whichever is longer.
- Patient treated with any investigational drug within 30 days (or 5 half-lives,
whichever is longer) prior to Visit 1.
- Patient on treatment with strong cytochrome P450 (CYP)3A4 inhibitors such as
ketoconazole or itraconazole or CYP3A4 inducers such as rifampin at Visit 1 or within
14 days prior to administration of IMP.
- Patient with a history, laboratory abnormality, or clinical suspicion of any
clinically relevant disease or disorder, including uncontrolled hypertension or
uncontrolled diabetes, which, in the opinion of the Investigator, may either put the
patient at risk because of participation in the study, or influence the results or the
patient's ability to participate in the study, or any other safety concerns in the
opinion of the Investigator.
- Patient with diagnosis of any kind of chronic hepatitis or known human
immunodeficiency virus (HIV) infections at the time of enrolment.
- Patient with any active malignancy or treatment thereof within the five years prior to
enrolment.
- Patient with any clinically important abnormalities in rhythm, conduction, or
morphology of the screening 12-lead ECG as judged by the Investigator on the screening
ECG.
- Patient with prolonged QT interval using Fridericia's correction = 450 msec for males
and females on the screening ECG or family history of long QT syndrome.
- Patient with PR (PQ) interval prolongation (> 240 msec), intermittent second or third
degree atrio-ventricular (AV) block or AV dissociation or with QRS interval = 120 msec
or any other ECG abnormality which might affect the evaluation of the central ECG
reading on the screening ECG.
- Patient with heart rate (HR) < 45 beat per minute (bpm) or > 90 bpm at Screening ECG.
- Patient with implanted cardiac defibrillator and patients with sustained symptomatic
ventricular and/or atrial tachyarrhythmia.
- Patient with any contraindication against the use of sympathomimetic drugs as judged
by the Investigator.
- Patient with unstable angina pectoris or stable angina pectoris classified higher than
Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within
6 months before Visit 1.
- Patient with a history of hospitalization within 12 months caused by heart failure or
a diagnosis of heart failure higher than New York Heart Association (NYHA) Class II.
- Patient who failed the screening procedures or patient with previous participation in
the current study. Patients who failed the screening procedures may be re-screened
once only.
- Patient with a history of or current alcohol or drug abuse (including marijuana), as
judged by the Investigator.
- Patient with planned in-patient surgery, major dental procedure or hospitalization
during the study.
- Patient involved in the planning and/or conduct of the study (applies to both
AstraZeneca staff, contract research organization (CRO) staff and/or staff at the
study site).
- Vulnerable person (e.g., per;
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific
procedures.
- Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma
and with suitable veins for cannulation or repeated venipuncture.
- Non-smoker or former smoker who quit = 6 months prior to Visit 1 and have a total
smoking history of = 10 pack-years. Note: Pack-years are calculated by dividing the
number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and
multiplying this figure by the number of years a person has been smoking. For example,
a person who smokes 40 cigarettes a day and has been smoking for 10 years would have a
20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 ×
10 years of smoking = 20 pack-year history).
- Patient with documented clinical diagnosis of asthma for = 6 months before Visit 1
according to Global Initiative for Asthma (GINA) guidelines.
- Patient with blood pressure (defined as systolic blood pressure [SBP] = 90 and = 140
mmHg, and diastolic blood pressure [DBP] = 50 and = 90 mmHg) at Screening, measured
after resting in the supine position for 5 minutes.
- Patient with no relevant clinical laboratory findings at Screening (Visits 1 or 2) as
judged by the Investigator.
- Patient on stable dose of ICSs for at least 1 month prior to Visit 1. Patients on
bronchodilators will need to do appropriate wash-out prior to the pulmonary function
test at Visit 2.
- Patient with pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Visit 2
= 40% and = 90% of predicted (mean of 2 pre-bronchodilator measurements taken 30
minutes apart).
- Patient who demonstrates the ability to use the study inhalation device properly.
Patient able to perform acceptable pulmonary function testing for FEV1 according to
American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria.
- Negative pregnancy test (serum pregnancy test at Screening) for female patients.
- Female patients must be post-menopausal, surgically sterile, or must be able to
adhere to the conditions of contraceptive requirements. Male patients must be
surgically sterile or must be able to adhere to the conditions of contraceptive
requirements.
- Patients willing not to donate blood during the study and for 3 months following their
last dose of IMP.
- Patient willing and able to follow study directions and restrictions.
- Patient must be able to read, speak and understand German language.
Exclusion Criteria:
- Patient has known or suspected hypersensitivity to the IMP or excipients, including
lactose (Note: lactose intolerance is not an exclusion criterion).
- Patient who has used systemic steroid in the 6 weeks before Visit 1.
- Patient with a history of hospitalization due to asthma in the 6 months prior to Visit
1 or a history of intubation because of asthma at any time in their lifetime.
- Patient with any active pulmonary disease other than asthma.
- Patient non-compliant with study procedures in the Screening period (prior to
randomization) -as judged by the Investigator.
- Patient under treatment with biologicals such as monoclonal antibodies or chimeric
biomolecules including omalizumab, mepolizumab, and reslizumab within 6 months or 5
half-lives before Visit 1, whichever is longer.
- Patient treated with any investigational drug within 30 days (or 5 half-lives,
whichever is longer) prior to Visit 1.
- Patient on treatment with strong cytochrome P450 (CYP)3A4 inhibitors such as
ketoconazole or itraconazole or CYP3A4 inducers such as rifampin at Visit 1 or within
14 days prior to administration of IMP.
- Patient with a history, laboratory abnormality, or clinical suspicion of any
clinically relevant disease or disorder, including uncontrolled hypertension or
uncontrolled diabetes, which, in the opinion of the Investigator, may either put the
patient at risk because of participation in the study, or influence the results or the
patient's ability to participate in the study, or any other safety concerns in the
opinion of the Investigator.
- Patient with diagnosis of any kind of chronic hepatitis or known human
immunodeficiency virus (HIV) infections at the time of enrolment.
- Patient with any active malignancy or treatment thereof within the five years prior to
enrolment.
- Patient with any clinically important abnormalities in rhythm, conduction, or
morphology of the screening 12-lead ECG as judged by the Investigator on the screening
ECG.
- Patient with prolonged QT interval using Fridericia's correction = 450 msec for males
and females on the screening ECG or family history of long QT syndrome.
- Patient with PR (PQ) interval prolongation (> 240 msec), intermittent second or third
degree atrio-ventricular (AV) block or AV dissociation or with QRS interval = 120 msec
or any other ECG abnormality which might affect the evaluation of the central ECG
reading on the screening ECG.
- Patient with heart rate (HR) < 45 beat per minute (bpm) or > 90 bpm at Screening ECG.
- Patient with implanted cardiac defibrillator and patients with sustained symptomatic
ventricular and/or atrial tachyarrhythmia.
- Patient with any contraindication against the use of sympathomimetic drugs as judged
by the Investigator.
- Patient with unstable angina pectoris or stable angina pectoris classified higher than
Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within
6 months before Visit 1.
- Patient with a history of hospitalization within 12 months caused by heart failure or
a diagnosis of heart failure higher than New York Heart Association (NYHA) Class II.
- Patient who failed the screening procedures or patient with previous participation in
the current study. Patients who failed the screening procedures may be re-screened
once only.
- Patient with a history of or current alcohol or drug abuse (including marijuana), as
judged by the Investigator.
- Patient with planned in-patient surgery, major dental procedure or hospitalization
during the study.
- Patient involved in the planning and/or conduct of the study (applies to both
AstraZeneca staff, contract research organization (CRO) staff and/or staff at the
study site).
- Vulnerable person (e.g., per;
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific
procedures.
- Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma
and with suitable veins for cannulation or repeated venipuncture.
- Non-smoker or former smoker who quit = 6 months prior to Visit 1 and have a total
smoking history of = 10 pack-years. Note: Pack-years are calculated by dividing the
number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and
multiplying this figure by the number of years a person has been smoking. For example,
a person who smokes 40 cigarettes a day and has been smoking for 10 years would have a
20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 ×
10 years of smoking = 20 pack-year history).
- Patient with documented clinical diagnosis of asthma for = 6 months before Visit 1
according to Global Initiative for Asthma (GINA) guidelines.
- Patient with blood pressure (defined as systolic blood pressure [SBP] = 90 and = 140
mmHg, and diastolic blood pressure [DBP] = 50 and = 90 mmHg) at Screening, measured
after resting in the supine position for 5 minutes.
- Patient with no relevant clinical laboratory findings at Screening (Visits 1 or 2) as
judged by the Investigator.
- Patient on stable dose of ICSs for at least 1 month prior to Visit 1. Patients on
bronchodilators will need to do appropriate wash-out prior to the pulmonary function
test at Visit 2.
- Patient with pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Visit 2
= 40% and = 90% of predicted (mean of 2 pre-bronchodilator measurements taken 30
minutes apart).
- Patient who demonstrates the ability to use the study inhalation device properly.
Patient able to perform acceptable pulmonary function testing for FEV1 according to
American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria.
- Negative pregnancy test (serum pregnancy test at Screening) for female patients.
- Female patients must be post-menopausal, surgically sterile, or must be able to
adhere to the conditions of contraceptive requirements. Male patients must be
surgically sterile or must be able to adhere to the conditions of contraceptive
requirements.
- Patients willing not to donate blood during the study and for 3 months following their
last dose of IMP.
- Patient willing and able to follow study directions and restrictions.
- Patient must be able to read, speak and understand German language.
Exclusion Criteria:
- Patient has known or suspected hypersensitivity to the IMP or excipients, including
lactose (Note: lactose intolerance is not an exclusion criterion).
- Patient who has used systemic steroid in the 6 weeks before Visit 1.
- Patient with a history of hospitalization due to asthma in the 6 months prior to Visit
1 or a history of intubation because of asthma at any time in their lifetime.
- Patient with any active pulmonary disease other than asthma.
- Patient non-compliant with study procedures in the Screening period (prior to
randomization) -as judged by the Investigator.
- Patient under treatment with biologicals such as monoclonal antibodies or chimeric
biomolecules including omalizumab, mepolizumab, and reslizumab within 6 months or 5
half-lives before Visit 1, whichever is longer.
- Patient treated with any investigational drug within 30 days (or 5 half-lives,
whichever is longer) prior to Visit 1.
- Patient on treatment with strong cytochrome P450 (CYP)3A4 inhibitors such as
ketoconazole or itraconazole or CYP3A4 inducers such as rifampin at Visit 1 or within
14 days prior to administration of IMP.
- Patient with a history, laboratory abnormality, or clinical suspicion of any
clinically relevant disease or disorder, including uncontrolled hypertension or
uncontrolled diabetes, which, in the opinion of the Investigator, may either put the
patient at risk because of participation in the study, or influence the results or the
patient's ability to participate in the study, or any other safety concerns in the
opinion of the Investigator.
- Patient with diagnosis of any kind of chronic hepatitis or known human
immunodeficiency virus (HIV) infections at the time of enrolment.
- Patient with any active malignancy or treatment thereof within the five years prior to
enrolment.
- Patient with any clinically important abnormalities in rhythm, conduction, or
morphology of the screening 12-lead ECG as judged by the Investigator on the screening
ECG.
- Patient with prolonged QT interval using Fridericia's correction = 450 msec for males
and females on the screening ECG or family history of long QT syndrome.
- Patient with PR (PQ) interval prolongation (> 240 msec), intermittent second or third
degree atrio-ventricular (AV) block or AV dissociation or with QRS interval = 120 msec
or any other ECG abnormality which might affect the evaluation of the central ECG
reading on the screening ECG.
- Patient with heart rate (HR) < 45 beat per minute (bpm) or > 90 bpm at Screening ECG.
- Patient with implanted cardiac defibrillator and patients with sustained symptomatic
ventricular and/or atrial tachyarrhythmia.
- Patient with any contraindication against the use of sympathomimetic drugs as judged
by the Investigator.
- Patient with unstable angina pectoris or stable angina pectoris classified higher than
Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within
6 months before Visit 1.
- Patient with a history of hospitalization within 12 months caused by heart failure or
a diagnosis of heart failure higher than New York Heart Association (NYHA) Class II.
- Patient who failed the screening procedures or patient with previous participation in
the current study. Patients who failed the screening procedures may be re-screened
once only.
- Patient with a history of or current alcohol or drug abuse (including marijuana), as
judged by the Investigator.
- Patient with planned in-patient surgery, major dental procedure or hospitalization
during the study.
- Patient involved in the planning and/or conduct of the study (applies to both
AstraZeneca staff, contract research organization (CRO) staff and/or staff at the
study site).
- Vulnerable person (e.g., per;
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific
procedures.
- Male and non-pregnant, non-lactating female patients aged 18 - 55 years with asthma
and with suitable veins for cannulation or repeated venipuncture.
- Non-smoker or former smoker who quit = 6 months prior to Visit 1 and have a total
smoking history of = 10 pack-years. Note: Pack-years are calculated by dividing the
number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and
multiplying this figure by the number of years a person has been smoking. For example,
a person who smokes 40 cigarettes a day and has been smoking for 10 years would have a
20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 ×
10 years of smoking = 20 pack-year history).
- Patient with documented clinical diagnosis of asthma for = 6 months before Visit 1
according to Global Initiative for Asthma (GINA) guidelines.
- Patient with blood pressure (defined as systolic blood pressure [SBP] = 90 and = 140
mmHg, and diastolic blood pressure [DBP] = 50 and = 90 mmHg) at Screening, measured
after resting in the supine position for 5 minutes.
- Patient with no relevant clinical laboratory findings at Screening (Visits 1 or 2) as
judged by the Investigator.
- Patient on stable dose of ICSs for at least 1 month prior to Visit 1. Patients on
bronchodilators will need to do appropriate wash-out prior to the pulmonary function
test at Visit 2.
- Patient with pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Visit 2
= 40% and = 90% of predicted (mean of 2 pre-bronchodilator measurements taken 30
minutes apart).
- Patient who demonstrates the ability to use the study inhalation device properly.
Patient able to perform acceptable pulmonary function testing for FEV1 according to
American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria.
- Negative pregnancy test (serum pregnancy test at Screening) for female patients.
- Female patients must be post-menopausal, surgically sterile, or must be able to
adhere to the conditions of contraceptive requirements. Male patients must be
surgically sterile or must be able to adhere to the conditions of contraceptive
requirements.
- Patients willing not to donate blood during the study and for 3 months following their
last dose of IMP.
- Patient willing and able to follow study directions and restrictions.
- Patient must be able to read, speak and understand German language.
Exclusion Criteria:
- Patient has known or suspected hypersensitivity to the IMP or excipients, including
lactose (Note: lactose intolerance is not an exclusion criterion).
- Patient who has used systemic steroid in the 6 weeks before Visit 1.
- Patient with a history of hospitalization due to asthma in the 6 months prior to Visit
1 or a history of intubation because of asthma at any time in their lifetime.
- Patient with any active pulmonary disease other than asthma.
- Patient non-compliant with study procedures in the Screening period (prior to
randomization) -as judged by the Investigator.
- Patient under treatment with biologicals such as monoclonal antibodies or chimeric
biomolecules including omalizumab, mepolizumab, and reslizumab within 6 months or 5
half-lives before Visit 1, whichever is longer.
- Patient treated with any investigational drug within 30 days (or 5 half-lives,
whichever is longer) prior to Visit 1.
- Patient on treatment with strong cytochrome P450 (CYP)3A4 inhibitors such as
ketoconazole or itraconazole or CYP3A4 inducers such as rifampin at Visit 1 or within
14 days prior to administration of IMP.
- Patient with a history, laboratory abnormality, or clinical suspicion of any
clinically relevant disease or disorder, including uncontrolled hypertension or
uncontrolled diabetes, which, in the opinion of the Investigator, may either put the
patient at risk because of participation in the study, or influence the results or the
patient's ability to participate in the study, or any other safety concerns in the
opinion of the Investigator.
- Patient with diagnosis of any kind of chronic hepatitis or known human
immunodeficiency virus (HIV) infections at the time of enrolment.
- Patient with any active malignancy or treatment thereof within the five years prior to
enrolment.
- Patient with any clinically important abnormalities in rhythm, conduction, or
morphology of the screening 12-lead ECG as judged by the Investigator on the screening
ECG.
- Patient with prolonged QT interval using Fridericia's correction = 450 msec for males
and females on the screening ECG or family history of long QT syndrome.
- Patient with PR (PQ) interval prolongation (> 240 msec), intermittent second or third
degree atrio-ventricular (AV) block or AV dissociation or with QRS interval = 120 msec
or any other ECG abnormality which might affect the evaluation of the central ECG
reading on the screening ECG.
- Patient with heart rate (HR) < 45 beat per minute (bpm) or > 90 bpm at Screening ECG.
- Patient with implanted cardiac defibrillator and patients with sustained symptomatic
ventricular and/or atrial tachyarrhythmia.
- Patient with any contraindication against the use of sympathomimetic drugs as judged
by the Investigator.
- Patient with unstable angina pectoris or stable angina pectoris classified higher than
Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within
6 months before Visit 1.
- Patient with a history of hospitalization within 12 months caused by heart failure or
a diagnosis of heart failure higher than New York Heart Association (NYHA) Class II.
- Patient who failed the screening procedures or patient with previous participation in
the current study. Patients who failed the screening procedures may be re-screened
once only.
- Patient with a history of or current alcohol or drug abuse (including marijuana), as
judged by the Investigator.
- Patient with planned in-patient surgery, major dental procedure or hospitalization
during the study.
- Patient involved in the planning and/or conduct of the study (applies to both
AstraZeneca staff, contract research organization (CRO) staff and/or staff at the
study site).
- Vulnerable person (e.g., per",NULL,"Observed maximum plasma concentration (Cmax) assessment for abediterol on Day 1;Time to reach maximum plasma concentration (tmax) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 1;Observed maximum concentration (Cmax) assessment for abediterol on Day 9;Time to reach maximum concentration (tmax) assessment for abediterol on Day 9;Terminal rate constant, estimated by log-linear LS regression of the terminal part of the concentration-time curve (?z) assessment for abediterol on Day 9;Terminal half-life, estimated as (ln2)/?z (t½?z) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 9;Apparent clearance for drug estimated as dose divided by AUC0-24 (CL/F) assessment for abediterol on Day 9;Average plasma concentration during a dosing interval, estimated as AUC0-24/24 (Cavg) assessment for abediterol on Day 9;Fluctuation index during a dosing interval estimated as 100*(Cmax - Cmin)/Cavg (%), where Cmin is the minimum concentration at the end of the dosing interval (%Fluctuation) assessment for abediterol on Day 9;Accumulation ratio for Cmax estimated as (Cmax on Day 9/Cmax on Day 1) (Rac (Cmax)) assessment for abediterol on Day 9;Accumulation ratio for AUC0-24 estimated as (AUC0-24 on Day 9/AUC0-24 on Day 1) (Rac (AUC0-24)) assessment for abediterol on Day 9;Vital sign (Blood pressure [BP]);Vital sign (pulse);12-lead Electrocardiograms (ECGs) including high precision QTc analysis and telemetry;Clinical laboratory assessments (hematology, clinical chemistry and urinalysis);Number of patients with Adverse Events (AEs);Observed maximum plasma concentration (Cmax) assessment for abediterol on Day 1;Time to reach maximum plasma concentration (tmax) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 1;Observed maximum concentration (Cmax) assessment for abediterol on Day 9;Time to reach maximum concentration (tmax) assessment for abediterol on Day 9;Terminal rate constant, estimated by log-linear LS regression of the terminal part of the concentration-time curve (?z) assessment for abediterol on Day 9;Terminal half-life, estimated as (ln2)/?z (t½?z) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 9;Apparent clearance for drug estimated as dose divided by AUC0-24 (CL/F) assessment for abediterol on Day 9;Average plasma concentration during a dosing interval, estimated as AUC0-24/24 (Cavg) assessment for abediterol on Day 9;Fluctuation index during a dosing interval estimated as 100*(Cmax - Cmin)/Cavg (%), where Cmin is the minimum concentration at the end of the dosing interval (%Fluctuation) assessment for abediterol on Day 9;Accumulation ratio for Cmax estimated as (Cmax on Day 9/Cmax on Day 1) (Rac (Cmax)) assessment for abediterol on Day 9;Accumulation ratio for AUC0-24 estimated as (AUC0-24 on Day 9/AUC0-24 on Day 1) (Rac (AUC0-24)) assessment for abediterol on Day 9;Vital sign (Blood pressure [BP]);Vital sign (pulse);12-lead Electrocardiograms (ECGs) including high precision QTc analysis and telemetry;Clinical laboratory assessments (hematology, clinical chemistry and urinalysis);Number of patients with Adverse Events (AEs);Observed maximum plasma concentration (Cmax) assessment for abediterol on Day 1;Time to reach maximum plasma concentration (tmax) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 1;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 1;Observed maximum concentration (Cmax) assessment for abediterol on Day 9;Time to reach maximum concentration (tmax) assessment for abediterol on Day 9;Terminal rate constant, estimated by log-linear LS regression of the terminal part of the concentration-time curve (?z) assessment for abediterol on Day 9;Terminal half-life, estimated as (ln2)/?z (t½?z) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUClast) assessment for abediterol on Day 9;Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC(0-24)) assessment for abediterol on Day 9;Apparent clearance for drug estimated as dose divided by AUC0-24 (CL/F) assessment for abediterol on Day 9;Average plasma concentration during a dosing interval, estimated as AUC0-24/24 (Cavg) assessment for abediterol on Day 9;Fluctuation index during a dosing interval estimated as 100*(Cmax - Cmin)/Cavg (%), where Cmin is the minimum concentration at the end of the dosing interval (%Fluctuation) assessment for abediterol on Day 9;Accumulation ratio for Cmax estimated as (Cmax on Day 9/Cmax on Day 1) (Rac (Cmax)) assessment for abediterol on Day 9;Accumulation ratio for AUC0-24 estimated as (AUC0-24 on Day 9/AUC0-24 on Day 1) (Rac (AUC0-24)) assessment for abediterol on Day 9;Vital sign (Blood pressure [BP]);Vital sign (pulse);12-lead Electrocardiograms (ECGs) including high precision QTc analysis and telemetry;Clinical laboratory assessments (hematology, clinical chemistry and urinalysis);Number of patients with Adverse Events (AEs)",NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-09-21,2017-09-04,2017-09-04,12,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2017-11-24,TRUE,FALSE,FALSE
2186,NCT03226392,NA,NCT03226392,NCT: 2017-07-11 ICTRP: 2017-07-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 702 ICTRP: 702 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Poster,https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A1408,NA,2017-07-21,NA,2017-10-31,2019-08-01,Interventional,Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma,"A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma",Completed,Phase 3,704,Actual,Novartis,Change From Baseline in Pre-dose FEV1,Change From Baseline in Daytime Asthma Symptom Score;Change From Baseline in Number of Puffs of SABA Taken Per Day;Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score,2017-001272-40;CQAW039A2317,Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma,"A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma",NULL,NULL,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2017-07-11,2017-10-31,704,Completed,Novartis Pharmaceuticals,NULL,"united states;brazil;bulgaria;canada;colombia;germany;hungary;india;israel;italy;korea, republic of;peru;puerto rico;russian federation;spain;sweden;tunisia;vietnam;brazil;bulgaria;canada;colombia;germany;hungary;india;israel;italy;korea, republic of;peru;puerto rico;russian federation;spain;sweden;tunisia;united states;vietnam",Drug: QAW039;Drug: Placebo,"
Inclusion Criteria:
- A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
- Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose
ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor
antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1
and the doses have been stable for at least 4 weeks prior to Visit 1.
- FEV1 of =85% for patients aged =18 years. FEV1 of =90% for patients aged 12 to <18
years.
- Daytime asthma symptom score (0 to 6 scale) of =1 per day during 4 of the last 7 days
of the placebo run- in period.
- Total daily SABA use =1 puff per day during 4 of the last 7 days of the placebo run-in
period.
- Demonstrated reversible airway obstruction.
- Asthma control questionnaire (ACQ) score = 1.5.
Exclusion Criteria:
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30
days, whichever is longer.
- A resting QTcF (Fridericia) =450 msec (male) or
=460 msec (female).
- Pregnant or nursing (lactating) women.
- Serious co-morbidities.
- Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
>2 mg of pitavastatin.
Other protocol-defined inclusion/exclusion criteria may apply.
",NULL,Change From Baseline in Pre-dose FEV1,Change From Baseline in Daytime Asthma Symptom Score;Change From Baseline in Number of Puffs of SABA Taken Per Day;Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-10-31,2017-07-11,2017-07-11,704,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2020-02-17,TRUE,FALSE,TRUE
2202,NCT03220178,NA,NCT03220178,NCT: 2017-07-06 ICTRP: 2017-07-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,5,NA,NA,NCT: Anticipated 960 ICTRP: 960 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Abstract,https://doi.org/10.1093/annonc/mdz242.084,NA,2017-07-18,NA,2017-07-24,2027-06-30,Interventional,Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy,"PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant",Recruiting,Phase 4,960,Anticipated,Palleos Healthcare GmbH,DQoL,Progression-free survival;Overall survival;Drug intake;Global health status,PH001-PreCycle,Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy,"PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant",;info@palleos.com;,;info@palleos.com;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 4,2017-07-06,2017-07-24,960,Recruiting,Palleos Healthcare GmbH,WSG WOMEN´S HEALTHCARE STUDY GROUP;Cankado Service GmbH;Pfizer;AGO-TraFo;AGO-B;Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie e.V.,germany,Drug: Palbociclib;Drug: Fulvestrant;Drug: Anastrozole;Drug: Letrozole;Drug: Exemestane,"
Inclusion Criteria:
1. Post- or pre/peri-menopausal female patients, age =18 years
2. Patients with metastatic or locally advanced (non-operable) breast cancer disease
3. Patients who are appropriate candidates for aromatase inhibitor + palbociclib
combination therapy OR Patients having already received endocrine therapy who are
appropriate candidates for fulvestrant+ palbociclib combination therapy
4. Patient has not received treatment for locally advanced or metastatic disease OR
Patient has received one prior line of chemotherapy and/or a maximum of two endocrine
therapy lines for locally advanced or metastatic disease
5. Peri-/pre-menopausal patients should additionally receive a GnRH-agonist..
6. The tumor must be hormone-receptor positive
7. The tumor must be HER2-negative defined as either HER2 immunohistochemistry Score 0 or
1+ or as HER2-negative by in situ hybridization..
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
9. Adequate organ and marrow function before palbociclib treatment starts on C1D.
10. In case of patients of child bearing potential: negative pregnancy test (urine or
serum) at baseline. Patients must agree to use highly effective non-hormonal
contraception
11. Resolution of all acute toxic effects of prior therapy, including radiotherapy grade
<1 (except toxicities not considered a safety risk for the patient) and recovery from
surgical procedures
12. Signed Written Informed Consent
13. Willingness and capability to use CANKADO
14. Availability of hardware: Computer and/or tablet and/or smartphone with internet
access
Exclusion Criteria:
1. Known hypersensitivity to aromatase inhibitor, fulvestrant, palbociclib or any of its
excipients
2. Contraindication for aromatase inhibitor, fulvestrant or palbociclib; or GnRH-agonists
(if pre-menopausal)
3. Prior treatment with any inhibitor of cyclin dependent kinase (CDK).
4. Patients with locally advanced or metastatic, symptomatic, visceral spread, who are at
risk of life threatening complications in the short term
5. Known active uncontrolled or symptomatic central nervous system metastases
6. Current use of food or drugs known to be potent inhibitors or inducers of Cytochrome
P450 3A4 (CYP3A4)
7. High cardiovascular risk, including, but not limited to recent myocardial infarction,
severe/unstable angina, or severe cardiac dysrhythmias in the past 6 months of
enrollment
8. Diagnosis of any second malignancy within the last 5 years prior to enrollment, except
for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
of the cervix
9. Participation in other clinical trials involving investigational drug(s) (Phases 1-4)
within 2 weeks before the current study begins and/or during study participation
10. Lactating women
11. Life expectancy < 3 months
12. Known infection with HIV, hepatitis B virus, or hepatitis C virus
13. Concurrent severe, uncontrolled systemic disease, social or psychiatric condition that
might interfere with the planned treatment and with the patient's adherence to the
protocol
14. Legal incapacity or limited legal capacity.
",NULL,DQoL,Progression-free survival;Overall survival;Drug intake;Global health status,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-07-24,2017-07-06,2017-07-06,960,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2020-11-24,TRUE,FALSE,FALSE
2333,NCT03178227,NA,NCT03178227,NCT: 2017-06-02 ICTRP: 2017-06-02 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Anticipated 1000 ICTRP: 1000 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Protokoll,https://doi.org/10.1136/bmjopen-2017-018589,NA,2017-06-06,NA,2018-02-01,2018-12-31,Interventional,Smokerface Mirroring in Brazil RCT,Randomized Trial of a Photoaging Mirroring Intervention to Prevent Smoking in Secondary Schools in Brazil - Study Protocol,Unknown status,N/A,1000,Anticipated,University of Giessen,The difference of prevalences after six months,The difference of prevalences after one month,SmokerfaceMirrorBrazil,Smokerface Mirroring in Brazil RCT,Randomized Trial of a Photoaging Mirroring Intervention to Prevent Smoking in Secondary Schools in Brazil - Study Protocol,titus.brinker@gmail.com;titus.brinker@gmail.com;titus.brinker@gmail.com;titus.brinker@gmail.com;titus.brinker@gmail.com,titus.brinker@gmail.com;titus.brinker@gmail.com;titus.brinker@gmail.com;titus.brinker@gmail.com;titus.brinker@gmail.com,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). ,N/A,2017-06-02,2018-02-01,1000,Not yet recruiting,University of Giessen,NULL,brazil;germany;brazil;germany;brazil;germany;brazil;germany;brazil;germany;brazil;germany;brazil;germany;brazil;germany;brazil;germany;brazil;germany,Behavioral: Photoaging Mirroring Intervention;Behavioral: Photoaging Mirroring Intervention;Behavioral: Photoaging Mirroring Intervention;Behavioral: Photoaging Mirroring Intervention,
Inclusion Criteria:
Visiting a Brazilian secondary school
Exclusion Criteria:
Not visiting a Brazilian secondary school
;
Inclusion Criteria:
Visiting a Brazilian secondary school
Exclusion Criteria:
Not visiting a Brazilian secondary school
;
Inclusion Criteria:
Visiting a Brazilian secondary school
Exclusion Criteria:
Not visiting a Brazilian secondary school
;
Inclusion Criteria:
Visiting a Brazilian secondary school
Exclusion Criteria:
Not visiting a Brazilian secondary school
,NULL,The difference of prevalences after six months;The difference of prevalences after six months;The difference of prevalences after six months,The difference of prevalences after one month,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-02-01,2017-06-02,2017-06-02,1000,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,2017-06-02,TRUE,FALSE,FALSE
2614,NCT03098849,NA,NCT03098849,NCT: 2017-03-10 ICTRP: 2017-03-10 DRKS: NA,1,NA,NA,0,NA,NA,"Criteria imply ""takes any asthma medication"" and should normally define asthma disease status, but the latter is not even mentioned",1,NA,Which exercises are possible?,4,NA,no AM,4,NA,no AM,NCT: Actual 63 ICTRP: 63 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-04-04,NA,2017-01-25,2017-10-26,Interventional,Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients,"Effectiveness of a Buteyko-based Breathing Technique on Psycho-physiological Parameters of Adults With Asthma - a Randomized, Controlled Study",Completed,N/A,63,Actual,ARCIM Institute Academic Research in Complementary and Integrative Medicine,Change in Endtidal CO2;Change in Nijmegen-Score;Change in Buteyko CP,Oxygen Saturation;Spirometry: FEV1;Spirometry: FEV1;Spirometry: FEV1/VCin;Spirometry: FEV1/VCin;Spirometry: PEF;Spirometry: PEF;Heart Rate Variability (SDNN);Heart Rate Variability (SDNN);Heart Rate Variability (RMSSD);Heart Rate Variability (RMSSD);Heart Rate Variability (LF/HF);Heart Rate Variability (LF/HF);Vascular stiffness;Vascular stiffness;Blood Pressure;Blood Pressure;Haemodynamics Stroke volume;Haemodynamics Stroke volume;Haemodynamics Cardiac output;Haemodynamics Cardiac output;Haemodynamics Total Vascular Resistance;Haemodynamics Total Vascular Resistance;Haemodynamics Cardiac index;Haemodynamics Cardiac index;Haemodynamics Perfusion;Haemodynamics Perfusion;Haemodynamics Plethvariability;Haemodynamics Plethvariability;Oxygen Saturation;ACQ;ACQ;AQLQ;AQLQ;ARCIM Questionnaire;ARCIM Questionnaire;STAI Questionnaire;STAI Questionnaire;ASF Questionnaire;ASF Questionnaire;Asthma medication;Asthma medication,RBT_10,Effectiveness of a Buteyko-based Breathing Technique for Asthma Patients,"Effectiveness of a Buteyko-based Breathing Technique on Psycho-physiological Parameters of Adults With Asthma - a Randomized, Controlled Study",NULL,NULL,Interventional,Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2017-03-10,2017-01-25,63,Completed,ARCIM Institute Academic Research in Complementary and Integrative Medicine,University Hospital Tuebingen,germany,Other: Buteyko Breathing Technique,"
Inclusion Criteria:
- Written informed consent, regular intake of prescribed asthma medication according to
the AWMF scheme level 1, native speaker of german
Exclusion Criteria:
- Participation in another study, comorbidities (heart diseases, cancer still under
treatment, psychiatric diseases)
",NULL,Change in Endtidal CO2;Change in Nijmegen-Score;Change in Buteyko CP,Spirometry: FEV1;Spirometry: FEV1;Spirometry: FEV1/VCin;Spirometry: FEV1/VCin;Spirometry: PEF;Spirometry: PEF;Heart Rate Variability (SDNN);Heart Rate Variability (SDNN);Heart Rate Variability (RMSSD);Heart Rate Variability (RMSSD);Heart Rate Variability (LF/HF);Heart Rate Variability (LF/HF);Vascular stiffness;Vascular stiffness;Blood Pressure;Blood Pressure;Haemodynamics Stroke volume;Haemodynamics Stroke volume;Haemodynamics Cardiac output;Haemodynamics Cardiac output;Haemodynamics Total Vascular Resistance;Haemodynamics Total Vascular Resistance;Haemodynamics Cardiac index;Haemodynamics Cardiac index;Haemodynamics Perfusion;Haemodynamics Perfusion;Haemodynamics Plethvariability;Haemodynamics Plethvariability;Oxygen Saturation;Oxygen Saturation;ACQ;ACQ;AQLQ;AQLQ;ARCIM Questionnaire;ARCIM Questionnaire;STAI Questionnaire;STAI Questionnaire;ASF Questionnaire;ASF Questionnaire;Asthma medication;Asthma medication,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-01-25,2017-03-10,2017-03-10,63,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,FALSE,NA,TRUE,2017,2018-05-08,TRUE,FALSE,FALSE
2701,NCT03076086,NA,NCT03076086,NCT: 2017-03-06 ICTRP: 2017-03-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,NA,NA,NA,NA,NCT: Actual 21 ICTRP: 21 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-03-09,NA,2017-05-12,2018-01-15,Interventional,Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum,Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum Samples of Healthy Smokers and Non Smokers,Completed,N/A,21,Actual,Fraunhofer-Institute of Toxicology and Experimental Medicine,Biomarker assessment,,16-11 SPUFO I,Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum,Investigation of Secreted Phosphoproteins and PiP3 (Phosphoinositolphospat 3) in Sputum Samples of Healthy Smokers and Non Smokers,,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label). ,N/A,2017-03-06,2017-05-12,21,Completed,Fraunhofer-Institute of Toxicology and Experimental Medicine,NULL,germany,Other: Induced sputum procedure,"
Inclusion Criteria:
- • Healthy male and female subjects, aged 25-45 years. Women will be considered for
inclusion if they are not pregnant, as confirmed by pregnancy test and not nursing.
Females of childbearing potential need to use a highly effective method of contraception
during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the
female should be such that there is complete abstinence from intercourse from two weeks
prior to the first visit until at least 72 hours after the last visit -, implants,
injectables, combined oral contraceptives, hormonal IUDs (intrauterine device) or
double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel,
diaphragm, sponge, and cervical cap).
- Body weight = 50 kg and BMI (body mass index) within the range 19-32 kg/m²
- Smokers need to consume at least ten cigarettes per day and need to have at least ten
packyear
- Non-smokers need to be non-smoking since at least a year with a smoking history of no
more than 1 packyear.
- FEV1 (forced expiratory volume at one second)=80% predicted and FEV1/FVC (forced
expiratory vital capacity) =70%
Exclusion Criteria:
- • History of an acute infection four weeks prior to the informed consent visit.
- Regular intake of medication.
- Past or present disease, which as judged by the investigator, may affect the
outcome of this study. These diseases include, but are not limited to,
cardiovascular disease, malignancy, hepatic disease, renal disease, hematological
disease, neurological disease, endocrine disease or pulmonary disease (including
but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis
or cystic fibrosis).
- Participation in another clinical trial 30 days prior to enrollment.
",NULL,Biomarker assessment,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-05-12,2017-03-06,2017-03-06,21,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2018-01-30,TRUE,FALSE,FALSE
2743,NCT03065023,NA,NCT03065023,NCT: 2017-02-10 ICTRP: 2017-02-10 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 15 ICTRP: 15 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,kein Outcome,kein Artikel,NA,NA,2017-02-27,NA,2017-04-25,2018-05-18,Interventional,Study of Intralesional Administration of MK-4621 (RGT100) in Adult Participants With Advanced or Recurrent Tumors (MK-4621-001/RGT100-001),"A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects With Advanced or Recurrent Tumors",Terminated,Phase 1/Phase 2,15,Actual,Merck Sharp & Dohme Corp.,Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria;Number of Participants Who Experienced a Serious Adverse Event (SAE);Number of Participants Who Discontinued Study Treatment Due to a Treatment-related Adverse Event (AE);Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria,Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST),2016-003028-22;RGT100-001;MK-4621-001;4621-001,Study of Intralesional Administration of MK-4621 (RGT100) in Adult Participants With Advanced or Recurrent Tumors (MK-4621-001/RGT100-001),"A Phase I/II, Multicenter, Open-label, Clinical Trial of Intratumoral/Intralesional Administration of RGT100 in Subjects With Advanced or Recurrent Tumors",,,Interventional,Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1/Phase 2,2017-02-10,2017-04-25,15,Terminated,Merck Sharp & Dohme Corp.,NULL,germany;spain;united kingdom;germany;spain;united kingdom,Drug: MK-4621,"
Inclusion Criteria:
1. Male or female aged =18 years
2. Participants with histologically or cytologically confirmed diagnosis of advanced or
recurrent tumors (including lymphomas) for whom all standard treatments have been used
or are not feasible and MK-4621 (RGT100) is a suitable treatment option and:
1. For Group A: has cutaneous, sub-cutaneous (SC), or lymph node injectable tumors
2. For Group B: has injectable liver tumors or liver metastases
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Life expectancy >3 months as assessed by the Investigator
5. Adequate organ function
6. Negative serum pregnancy test within 2 weeks before first dose of study drug if the
participant is a woman of childbearing potential. Participants and participant's
partners of childbearing potential must agree to use birth control consistently and
correctly during the study and for at least 6 months after the last study drug
application.
7. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST 1.1) and 1 separate injectable lesion with diameter =1 cm but <7 cm
8. Ability to provide written informed consent before any study drug-related screening
procedures being performed
Exclusion Criteria:
1. Any tumor-directed therapy within 4 weeks before study treatment
2. Treatment with investigational drugs within 4 weeks before study enrolment
3. Systemic steroids at a dose of >10 mg of prednisolone, >2 mg of dexamethasone a day or
equivalent, except topical (inhaled, topical, nasal) for the last 28 days and ongoing
4. Participants with rapidly progressing disease (as determined by the Investigator)
5. Ongoing immune-related adverse events (irAEs) and/or adverse events (AEs) = grade 2
not resolved from previous therapies except vitiligo, stable neuropathy grade 2, hair
loss, and stable endocrinopathies with substitutive hormone therapy
6. Within 4 weeks of major surgery
7. Prior splenectomy
8. Documented history of active autoimmune disorders requiring systemic immunosuppressive
therapy
9. Primary or secondary immune deficiency
10. Active allergy requiring systemic medication or active infections requiring
anti-infectious therapy
11. Seropositive (except after vaccination) for human immunodeficiency virus (HIV),
hepatitis B virus (HBV) or hepatitis C virus (HCV)
12. Clinically significant cardiac disease including heart failure (New York Heart
Association, Class III or IV), pre-existing arrhythmia, uncontrolled angina pectoris,
or myocardial infarction within 1 year before study entry
13. Dementia or altered mental status that would prohibit informed consent
14. Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study assessed by the
Investigator
15. History of stroke, seizures, encephalitis, or multiple sclerosis
16. Gastric ulcer or inflammatory bowel disease or Crohn's disease or ulcerative colitis
in the last 6 months
17. Active drug or alcohol abuse
18. Pregnant or breast feeding
",NULL,Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria;Number of Participants Who Experienced a Serious Adverse Event (SAE);Number of Participants Who Discontinued Study Treatment Due to a Treatment-related Adverse Event (AE);Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria,Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-04-25,2017-02-10,2017-02-10,15,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2019-07-22,TRUE,FALSE,TRUE
3045,NCT02986503,NA,NCT02986503,NCT: 2016-11-25 ICTRP: 2016-11-25 DRKS: NA,1,1,NA,1,1,NA,NA,NA,NA,NA,4,1,Progression not defined,4,0,Progression not defined; not reported,NCT: Actual 100 ICTRP: 100 DRKS: NA,218,1,NA,NA,NA,NA,NA,NA,NA,0,NA,ganzer Artikel,https://doi.org/10.5301%2Ftj.5000696,2018-04-27,2016-12-08,NA,2002-01-31,2016-11-30,Observational,European Study in Bone Sarcoma Patients Over 40 Years,A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years,Completed,NA,100,Actual,Italian Sarcoma Group,Event-free survival,Progression-free survival;Disease-free survival;Metastasis-free survival;Overall survival;Chemotherapy toxicity,EURO-B.O.S.S,European Study in Bone Sarcoma Patients Over 40 Years,A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years,,,Observational,Time Perspective: Prospective,N/A,2016-11-25,2002-01-20,100,Completed,Italian Sarcoma Group,Scandinavian Sarcoma Group;Cooperative Osteosarcoma Study Group,germany;italy;sweden;germany;italy;sweden,Drug: Doxorubicin+cisplatin+ifosfamide;Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate,"
Inclusion Criteria:
1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.
2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary),
fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated
chondrosarcoma, angiosarcoma.
3. Age: 41 - 65
4. Normal bone marrow, hepatic, cardiac and renal function
5. Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide
6. Written informed consent
Exclusion Criteria:
1. Planned chemotherapy and/or follow-up not feasible
2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs,
included in the present protocol
3. Previous chemotherapy treatment for the current tumor
4. White blood count < 3.0 x 109/L, and platelets < 100 x 109/L
5. Creatinine clearance < 70 ml/min
6. Left ventricular ejection fraction < 55% or fractional shortening rate of the left
ventricle <28%
7. Serum transaminases and bilirubin > 2 times the normal values
8. ECOG performance status > 2
9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma
and Ewing's family tumors.
",NULL,Event-free survival,Progression-free survival;Disease-free survival;Metastasis-free survival;Overall survival;Chemotherapy toxicity,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-01-31,2016-11-25,2016-11-25,100,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,2016-12-05,TRUE,FALSE,FALSE
3105,NCT02970747,NA,NCT02970747,NCT: 2016-11-10 ICTRP: 2016-11-10 DRKS: NA,1,NA,NA,1,NA,NA,Criteria missing,NA,NA,no dosages,2,NA,"no AM, no metric, no measure",2,NA,"no AM, no metric, no measure",NCT: Anticipated 450 ICTRP: 450 DRKS: NA,490,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2016-11-22,NA,2016-10-25,2023-12-23,Observational,Non-interventional Study of Kyprolis® in Combination With Revlimid® and Dexamethasone or Dexamethasone Alone in Multiple Myeloma Patients,A Non-interventional Study of Carfilzomib (Kyprolis®) in Combination With Lenalidomide (Revlimid®) and Dexamethasone or Carfilzomib in Combination With Dexamethasone Alone in Patients With Multiple Myeloma Who Have Received at Least One Prior Therapy,"Active, not recruiting",NA,300,Actual,iOMEDICO AG,Patients' adherence and persistence to carfilzomib therapy,Patients' adherence and persistence to lenalidomide and dexamethasone therapy,IOM-070337,Non-interventional Study of Kyprolis® in Combination With Revlimid® and Dexamethasone or Dexamethasone Alone in Multiple Myeloma Patients,A Non-interventional Study of Carfilzomib (Kyprolis®) in Combination With Lenalidomide (Revlimid®) and Dexamethasone or Carfilzomib in Combination With Dexamethasone Alone in Patients With Multiple Myeloma Who Have Received at Least One Prior Therapy,,,Observational,,,2016-11-10,2016-10-25,300,"Active, not recruiting",iOMEDICO AG,NULL,germany,Drug: Carfilzomib,
Inclusion Criteria:
- Aged 18 years or older.
- Patients with MM who have received at least one prior therapy.
- Indication for treatment as assessed by the treating physician.
- Decision for second- or subsequent-line treatment with the combination therapy
carfilzomib/ lenalidomide/ dexamethasone or carfilzomib/ dexamethasone
- Signed written informed consent.
- Criteria according to the current Summary of Product Characteristics (SmPC) for
Kyprolis® (Carfilzomib)
Exclusion Criteria:
- Contraindications according to the current SmPC for Kyprolis® (Carfilzomib)
,NULL,Patients' adherence and persistence to carfilzomib therapy,Patients' adherence and persistence to lenalidomide and dexamethasone therapy,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-10-25,2016-11-10,2016-11-10,300,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2016,2020-02-10,TRUE,FALSE,FALSE
3119,NCT02968004,NA,NCT02968004,NCT: 2016-11-13 ICTRP: 2016-11-13 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosages,4,NA,no AM,4,NA,no AM,NCT: Actual 224 ICTRP: 224 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Abstract,https://academic.oup.com/jes/article-pdf/doi/10.1210/jendso/bvaa046.1279/33187395/bvaa046.1279.pdf,NA,2016-11-18,NA,2016-12-31,2022-12-31,Interventional,Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children,"A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency","Active, not recruiting",Phase 3,224,Actual,"OPKO Health, Inc.",Annual Height Velocity,Height velocity at 6 months;Change in height Standard Deviation Score (SDS);Change in bone maturation (BM);IGF-1 serum levels;IGF-1 SDS serum levels;IGFBP-3 levels;IGFBP-3 SDS,CP-4-006,Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children,"A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2016-11-13,2016-12-20,224,"Active, not recruiting","OPKO Health, Inc.",NULL,"united states;argentina;australia;belarus;bulgaria;canada;colombia;georgia;greece;india;israel;korea, republic of;mexico;new zealand;poland;russian federation;spain;taiwan;ukraine;united kingdom;argentina;australia;belarus;bulgaria;canada;colombia;georgia;greece;india;israel;korea, republic of;mexico;new zealand;poland;russian federation;spain;taiwan;ukraine;united kingdom;united states;germany;italy;turkey",Drug: MOD-4023;Drug: Somatropin,"
Main Study Inclusion Criteria:
1. Pre-pubertal children aged =3 years , and not yet 11 years for girls or not yet 12
years with either isolated GHD, or GH insufficiency as part of multiple pituitary
hormone deficiency.
2. Confirmed diagnosis of GHD by two different GH provocation tests defined as a peak
plasma GH level of =10 ng/mL,
3. Bone age (BA) is not older than chronological age and should be less than 10 for girls
and less than 11 for boys.
4. Without prior exposure to any r-hGH therapy (naïve patients).
5. Impaired height and height velocity defined as:
- Annualized height velocity (HV) below the 25th percentile for CA (HV < -0.7 SDS)
and gender according to sponsor calculator using Tanner, Prader, and Hermanussen
- The interval between 2 height measurements should be at least 6 months, but
should not exceed 18 months prior to inclusion
6. Baseline IGF-I level of at least 1 SD below the mean IGF-1 level standardized for age
and sex (IGF-1 SDS =-1)
7. Normal calculated GFR per updated bedside Schwartz formula
8. Children with multiple hormonal deficiencies must be on stable replacement therapies
(no change in dose) for other hypothalamo-pituitary-organ axes for at least 3 months
prior ICF signing
9. Normal 46XX karyotype for girls.
10. Provide consent/assent
LT-OLE Inclusion Criteria:
11. Completion of the main study (12 months of treatment) with adequate compliance.
12. Provide consent/assent
13. Agree to refrain from sexual activity
Main Study Exclusion Criteria:
1. Children with prior history of leukemia, lymphoma, sarcoma or any other forms of
cancer.
2. History of radiation therapy or chemotherapy
3. Malnourished children defined as BMI < -2 SDS for age and sex
4. Children with psychosocial dwarfism
5. Children born small for gestational age (SGA - birth weight and/or birth length <-2
SDS for gestational age)
6. Presence of anti-hGH antibodies at screening
7. Any clinically significant abnormality likely to affect growth or the ability to
evaluate growth, such as, but not limited to, chronic diseases like renal
insufficiency, spinal cord irradiation, etc.
8. T2 and T1 diabetic patients, who in the opinion of the investigator are not receiving
standard of care treatment or are non-compliant with their prescribed treatment or who
are in poor metabolic control.
9. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan
syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX mutations/deletions and
skeletal dysplasias.
10. Concomitant administration of other treatments that may have an effect on growth such
as anabolic steroids, or sex steroids, with the exception of ADHD drugs or HRT
(thyroxin, hydrocortisone, desmopressin)
11. Children requiring glucocorticoid therapy (e.g. for asthma) that are taking
chronically a dose greater than 400 µg/d of inhaled budesonide or equivalent
12. Major medical conditions and/or presence of contraindication to r-hGH treatment.
13. More than one closed epiphyses
14. Known or suspected HIV-positive patient, or patient with advanced diseases such as
AIDS or tuberculosis.
15. Drug, substance, or alcohol abuse.
16. Known hypersensitivity to the components of study medication.
17. Other causes of short stature such as celiac disease, uncontrolled primary
hypothyroidism and rickets.
18. Possible non-compliance in respect to study conduct
19. Participation in any other trial of an investigational agent within 30 days prior to
consent
20. Study enrollment has been met or study is closed by sponsor prior to completion of
screening process.
LT-OLE Exclusion Criteria:
21. Concomitant administration of other treatments that may have an effect on growth such
as anabolic steroids, or sex steroids, with the exception of ADHD drugs or HRT
(thyroxin, hydrocortisone, desmopressin)
22. Change in medical condition during the treatment period (such as, but not limited to,
development of a serious inter-current critical illness, a severe adverse drug
reaction, etc.)
23. Positive pregnancy test
24. Unresolved drug related (Genotropin or MOD-4023) SAE from the treatment period as per
medical monitor judgement.
",NULL,Annual Height Velocity,Height velocity at 6 months;Change in height Standard Deviation Score (SDS);Change in bone maturation (BM);IGF-1 serum levels;IGF-1 SDS serum levels;IGFBP-3 levels;IGFBP-3 SDS,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-12-31,2016-11-13,2016-11-13,224,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2019-12-12,TRUE,FALSE,TRUE
3197,NCT02949011,NA,NCT02949011,NCT: 2016-10-27 ICTRP: 2016-10-27 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 2184 ICTRP: 2184 DRKS: NA,2184,1,1,2,1,NA,"Double (Participant, Investigator)","Double (patients, investigators, study personnel, and data
analysts)",better,0,Outcome fehlt,ganzer Artikel,https://doi.org/10.1016/s1473-3099(20)30004-9,2020-06-08,2016-10-31,NA,2017-01-11,2018-04-20,Interventional,Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications,"A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients With Influenza at High Risk of Influenza Complications",Completed,Phase 3,2184,Actual,Shionogi Inc.,Time to Improvement of Influenza Symptoms,Percentage of Participants With Adverse Events (AEs);Percentage of Participants With Positive Influenza Virus Titer at Each Time Point;Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point;Change From Baseline in Virus Titer at Each Time Point;Change From Baseline in Virus RNA (RT-PCR) at Each Time Point;Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer;Area Under the Curve (AUC) Adjusted by Baseline in Viral RNA;Time to Cessation of Viral Shedding Determined by Virus Titer;Time to Cessation of Viral Shedding Determined by Virus RNA;Percentage of Participants Whose Symptoms Were Improved at Each Time Point;Time to Alleviation of Symptoms;Time to Improvement of the Four Systemic Symptoms;Time to Improvement of the Three Respiratory Symptoms;Time to Resolution of Fever;Percentage of Participants Reporting Normal Temperature at Each Time Point;Body Temperature at Each Time Point;Time to Improvement of Individual Symptoms;Time to Return to Preinfluenza Health Status;Percentage of Participants Requiring Systemic Antibiotics for Infections Secondary to Influenza Infection;Percentage of Participants With Influenza-related Complications,2016-002688-32;1602T0832,Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications,"A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients With Influenza at High Risk of Influenza Complications",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2016-10-27,2017-01-11,2184,Completed,Shionogi,NULL,"australia;belgium;bulgaria;germany;hungary;japan;korea, republic of;latvia;new zealand;philippines;poland;romania;south africa;spain;taiwan;ukraine;united kingdom;united states",Drug: Baloxavir Marboxil;Drug: Placebo to Baloxavir Marboxil;Drug: Oseltamivir;Drug: Placebo to Oseltamivir,"
Inclusion Criteria:
1. Patients or their legal guardians who provide written informed consent to participate
in the study on a voluntary basis. For adolescent patients, informed consent/assent of
voluntary participation should be obtained in accordance with local requirements.
2. Male or female patients = 12 years at the time of signing the informed consent/assent
form.
3. Patients with a diagnosis of influenza confirmed by all of the following:
1. Fever = 38ºC (axillary) during the predose examinations or within the 4 hours
prior if antipyretics were taken
2. A positive rapid influenza diagnostic test (RIDT) result OR A patient with a
negative RIDT may be enrolled if the patient reports contact with a known case of
influenza within the prior 7 days and all other inclusion criteria are met.
3. At least 1 each of the following general and respiratory symptoms associated with
influenza is present with a severity of moderate or greater:
i. General symptoms (headache, feverishness or chills, muscle or joint pain, or
fatigue) ii. Respiratory symptoms (cough, sore throat, or nasal congestion)
4. The time interval between the onset of symptoms and the predose examinations is 48
hours or less. The onset of symptoms is defined as either:
1. Time of the first increase in body temperature (an increase of at least 1ºC from
normal body temperature)
2. Time when the patient experiences at least 1 new general or respiratory symptom
5. If a women of childbearing potential, agrees to use a highly effective method of
contraception for 3 months after the first dose of study drug
6. Patients will be considered at high risk* of influenza complications due to the
presence of at least 1 of the following inclusion criteria:
1. Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or
cystic fibrosis)
2. Endocrine disorders (including diabetes mellitus)
3. Residents of long-term care facilities (eg, nursing homes)
4. Compromised immune system (including patients receiving corticosteroids not
exceeding 20 mg of prednisolone or equivalent, and patients being treated for
human immunodeficiency virus [HIV] infection with a CD4 count > 350 cells/mm³
within the last 6 months)
5. Neurological and neurodevelopmental disorders (including disorders of the brain,
spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure
disorders], stroke, muscular dystrophy, or spinal cord injury)
6. Heart disease (such as congenital heart disease, congestive heart failure, or
coronary artery disease), excluding hypertension without any other heart-related
symptoms
7. Adults aged = 65 years
8. American Indians and Alaskan Natives
9. Blood disorders (such as sickle cell disease)
10. Metabolic disorders (such as inherited metabolic disorders and mitochondrial
disorders)
11. Morbid obesity (body mass index = 40 kg/m²)
12. Women who are within 2 weeks postpartum and are not breastfeeding
Exclusion Criteria:
1. Patients with severe influenza virus infection requiring inpatient treatment.
2. Patients with known allergy to oseltamivir (Tamiflu®).
3. Patients unable to swallow tablets or capsules.
4. Patients who have previously received baloxavir marboxil.
5. Patients weighing = 40 kg.
6. Patients who have been exposed to an investigational drug within 30 days prior to the
predose examinations.
7. Women who are pregnant, breastfeeding, or have a positive pregnancy test at the
predose examinations. The following female patients who have documentation of either a
or b below do not need to undergo a pregnancy test at the predose examinations:
1. Postmenopausal women (defined as cessation of regular menstrual periods for 2
years or more and confirmed by a follicle-stimulating hormone test)
2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or
tubal ligation
8. Patients with concurrent infections at the predose examinations requiring systemic
antimicrobial therapy.
9. Patients with liver disease associated with hepatic impairment.
10. Patients with cancer within the last 5 years (unless nonmelanoma skin cancer).
11. Patients with untreated HIV infection or treated HIV infection with a CD4 count below
350 cells/mm3 in the last 6 months.
12. Patients with immunosuppression following organ or bone marrow transplants.
13. Patients exceeding 20 mg of prednisolone or equivalent dose of chronic systemic
corticosteroids.
14. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir,
rimantadine, umifenovir or amantadine within 30 days prior to the predose
examinations.
15. Patients who have received an investigational monoclonal antibody for a viral disease
in the last year.
16. Patients with known creatinine clearance = 60 mL/min.
17. Patients who, in the opinion of the investigator, would be unlikely to comply with
required study visits, self-assessments, and interventions
",NULL,Time to Improvement of Influenza Symptoms,Percentage of Participants With Positive Influenza Virus Titer at Each Time Point;Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point;Change From Baseline in Virus Titer at Each Time Point;Change From Baseline in Virus RNA (RT-PCR) at Each Time Point;Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer;Area Under the Curve (AUC) Adjusted by Baseline in Viral RNA;Time to Cessation of Viral Shedding Determined by Virus Titer;Time to Cessation of Viral Shedding Determined by Virus RNA;Percentage of Participants Whose Symptoms Were Improved at Each Time Point;Time to Alleviation of Symptoms;Time to Improvement of the Four Systemic Symptoms;Time to Improvement of the Three Respiratory Symptoms;Time to Resolution of Fever;Percentage of Participants Reporting Normal Temperature at Each Time Point;Body Temperature at Each Time Point;Time to Improvement of Individual Symptoms;Time to Return to Preinfluenza Health Status;Percentage of Participants Requiring Systemic Antibiotics for Infections Secondary to Influenza Infection;Percentage of Participants With Influenza-related Complications;Percentage of Participants With Adverse Events (AEs),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-01-11,2016-10-27,2016-10-27,2184,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2019-11-06,TRUE,FALSE,TRUE
3240,NCT02936765,NA,NCT02936765,NCT: 2016-10-13 ICTRP: 2016-10-13 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Anticipated 52 ICTRP: 52 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-10-18,NA,2016-06-30,2019-06-30,Interventional,Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse,NA,Unknown status,N/A,52,Anticipated,Technische Universität Dresden,Change in Neck disability index compared to baseline,Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline;Change in EuroQOL (EQ-5D) compared to baseline;Change in Core Outcome Measure Index (COMI) compared to baseline;Change in flexion and extension radiographs compared to baseline (angle difference [deg]).;Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm]);Change in consumption of analgetics compared to baseline;Return to work;Return to work;Return to work;Return to work;Return to work;Mortality;Mortality;Mortality;Mortality;Mortality;Adverse effects;Adverse effects;Adverse effects;Adverse effects;Adverse effects,NCH_ESPvsSquale;NCH_ESPvsSquale,Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse,,bernhard.rieger@uniklinikum-dresden.de;bernhard.rieger@uniklinikum-dresden.de,bernhard.rieger@uniklinikum-dresden.de;bernhard.rieger@uniklinikum-dresden.de,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",N/A,2016-10-13,2016-06-20,52,Recruiting,Technische Universität Dresden,NULL,germany;germany,Device: Anterior cervical discectomy with prosthetic disc replacement / ESP.;Device: Anterior cervical discectomy with prosthetic disc replacement / Squale.;Device: Anterior cervical discectomy with prosthetic disc replacement / ESP.;Device: Anterior cervical discectomy with prosthetic disc replacement / Squale.,"
Inclusion Criteria:
- Indication for monosegmental anterior cervical discectomy with implantation of a disc
prosthesis
Exclusion Criteria:
- Radiologic signs of extensive bone degeneration in the affected segment
- Necessity of implantation of a device smaller in height than 5 mm (as predicted with
teh use of the Vertaplan (TM) software
- Transversal spine cord lesion
- Cervical myelopathy
- Preceding surgery on the cervical spine
- Traumatic lesions of the cervical spine
- Radiographic instability in the affected segment: flexion / extension: shift sagittal
plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray
examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width
and relative sagittal plane angulation > 11º
- signs of instability (Olisthesis) in another segment of the cervical spine
- Active systemic infection
- diseases of the rheumatic type and all autoimmune diseases
- bone metabolic diseases (for example, Paget's disease)
- skeletal metastases
- infections in the cervical spine
- Neurological seizure disorders or other serious neurological disease with risk of
falls
- Severe heart failure (NYHA III-IV)
- Bleeding disorders or clopidogrel / coumarins - treatment
- Systemic use of corticosteroids for more than a month in the last 12 months
- Pregnancy
- Legally incompetent patient
- Lactation
- Deformity, anomalies, not fully developed skeleton
- Local tumor disease
- Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's
disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy
- Drug / drug or alcohol dependence
;
Inclusion Criteria:
- Indication for monosegmental anterior cervical discectomy with implantation of a disc
prosthesis
Exclusion Criteria:
- Radiologic signs of extensive bone degeneration in the affected segment
- Necessity of implantation of a device smaller in height than 5 mm (as predicted with
teh use of the Vertaplan (TM) software
- Transversal spine cord lesion
- Cervical myelopathy
- Preceding surgery on the cervical spine
- Traumatic lesions of the cervical spine
- Radiographic instability in the affected segment: flexion / extension: shift sagittal
plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray
examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width
and relative sagittal plane angulation > 11º
- signs of instability (Olisthesis) in another segment of the cervical spine
- Active systemic infection
- diseases of the rheumatic type and all autoimmune diseases
- bone metabolic diseases (for example, Paget's disease)
- skeletal metastases
- infections in the cervical spine
- Neurological seizure disorders or other serious neurological disease with risk of
falls
- Severe heart failure (NYHA III-IV)
- Bleeding disorders or clopidogrel / coumarins - treatment
- Systemic use of corticosteroids for more than a month in the last 12 months
- Pregnancy
- Legally incompetent patient
- Lactation
- Deformity, anomalies, not fully developed skeleton
- Local tumor disease
- Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's
disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy
- Drug / drug or alcohol dependence
",NULL,Change in Neck disability index compared to baseline;Change in Neck disability index compared to baseline,Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline;Change in EuroQOL (EQ-5D) compared to baseline;Change in Core Outcome Measure Index (COMI) compared to baseline;Change in flexion and extension radiographs compared to baseline (angle difference [deg]).;Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm]);Change in consumption of analgetics compared to baseline;Return to work;Return to work;Return to work;Return to work;Return to work;Mortality;Mortality;Mortality;Mortality;Mortality;Adverse effects;Adverse effects;Adverse effects;Adverse effects;Adverse effects;Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline;Change in EuroQOL (EQ-5D) compared to baseline;Change in Core Outcome Measure Index (COMI) compared to baseline;Change in flexion and extension radiographs compared to baseline (angle difference [deg]).;Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm]);Change in consumption of analgetics compared to baseline;Return to work;Return to work;Return to work;Return to work;Return to work;Mortality;Mortality;Mortality;Mortality;Mortality;Adverse effects;Adverse effects;Adverse effects;Adverse effects;Adverse effects,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-06-30,2016-10-13,2016-10-13,52,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2016,2016-10-14,TRUE,FALSE,FALSE
3271,NCT02929368,NA,NCT02929368,NCT: 2016-07-01 ICTRP: 2016-07-01 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,4,1,no AM,4,1,no AM,NCT: Anticipated 210 ICTRP: 210 DRKS: NA,210,1,1,2,NA,NA,Single (participant),no info (likely no discrepancy),ok,1,NA,ganzer Artikel,https://doi.org/10.1007/s00270-020-02551-0,2020-06-17,2016-10-11,NA,2016-06-30,2018-03-31,Interventional,SHERLOCK 3CG vs. Fluoroscopy in Implantation of PICC-Line,Randomized Controlled Noninferiority Study to Evaluate Safety and Efficacy of the Integrated Magnetic Tracking and ECG-guided Tip Location System (SHERLOCK 3CG) vs. Fluoroscopy in Implantation of Peripherally Inserted Central Catheter,Completed,N/A,210,Actual,Jena University Hospital,Tip Placement efficiency measured by chest radiograph,Safety measured by follow-up interview with referring physician and documentation of AE;Implantation time,4567/10/15,SHERLOCK 3CG vs. Fluoroscopy in Implantation of PICC-Line,Randomized Controlled Noninferiority Study to Evaluate Safety and Efficacy of the Integrated Magnetic Tracking and ECG-guided Tip Location System (SHERLOCK 3CG) vs. Fluoroscopy in Implantation of Peripherally Inserted Central Catheter,,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant). ,N/A,2016-07-01,2016-06-20,210,Completed,Jena University Hospital,NULL,germany,Device: PICC implantation under fluoroscopy;Device: PICC Implantation under Sherlock System,"
Inclusion Criteria:
- female, male
- adults = 18 years
- medical indication for Power-PICC-Line catheter implantation because of chemotherapy
or parenertal nutrition
- in- and outpatients
Exclusion Criteria:
- children and adolescents < 18 years
- systemic or local infection of the interventional location
- known allergy to used material
- general contraindication of Power-PICC-Line catheter implantation
- nonexistent sinus rhythm (5)
",NULL,Tip Placement efficiency measured by chest radiograph,Safety measured by follow-up interview with referring physician and documentation of AE;Implantation time,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-06-30,2016-07-01,2016-07-01,210,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2016,2020-03-09,TRUE,FALSE,FALSE
3294,NCT02924688,NA,NCT02924688,NCT: 2016-09-12 ICTRP: 2016-09-12 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 2544 ICTRP: 2544 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Abstract,https://www.atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2020.201.1_MeetingAbstracts.A6247,NA,2016-10-05,NA,2016-10-13,2019-02-22,Interventional,"A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma","A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma",Completed,Phase 3,2436,Actual,GlaxoSmithKline,Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24,Annualized Rate of Moderate and Severe Asthma Exacerbations;Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24;Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24;Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24;Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period;Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE;Number of Participants With Abnormal Electrocardiogram (ECG) Findings;Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24;Mean Change From Baseline in Pulse Rate at Week 24;Number of Participants With Abnormal Clinical Chemistry Values;Number of Participants With Abnormal Hematology Values,2016-001304-37;205715,"A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma","A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). ",Phase 3,2016-09-12,2016-10-13,2436,Completed,GlaxoSmithKline,NULL,"united states;argentina;australia;canada;germany;italy;japan;korea, republic of;netherlands;poland;romania;russian federation;south africa;spain;united kingdom;argentina;australia;canada;germany;italy;japan;korea, republic of;netherlands;poland;romania;russian federation;south africa;spain;united kingdom;united states",Drug: FF/UMEC/VI (100/31.25/25) mcg;Drug: FF/UMEC/VI (100/62.5/25) mcg;Drug: FF/UMEC/VI (200/31.25/25) mcg;Drug: FF/UMEC/VI (200/62.5/25) mcg;Drug: FF/VI (100/25) mcg;Drug: FF/VI (200/25) mcg;Drug: Fluticasone/salmeterol (FSC);Drug: Albuterol/salbutamol;Device: ELLIPTA DPI;Device: DISKUS DPI;Device: METERED-DOSE INHALER (MDI),"
Inclusion Criteria for Screening
- Age: 18 years of age or older at the time of signing the informed consent.
- Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes
of Health at least one year prior to Visit 0.
- Symptomatic: Subjects with inadequately controlled asthma (ACQ-6 score >=1.5) despite
ICS/LABA maintenance therapy at Visit 1.
- Asthma Control: In the 1 year prior to Visit 1
- A documented healthcare contact for acute asthma symptoms or
- A documented temporary change in asthma therapy for acute asthma symptoms,
according to a pre-specified asthma action plan (or equivalent)
- Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily
ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma
medications during the 6 weeks immediately prior to Visit 0 (including no changes to a
stable total dose of ICS of >250 mcg/day fluticasone proprionate [FP, or equivalent]).
- Spirometry: A best pre-bronchodilator morning (ante meridian [AM]) FEV1 >=30% and <85%
of the predicted normal value at Visit 1. Predicted values will be based upon the
European Respiratory Society (ERS) Global Lung Function Initiative.
- Reversibility of Disease: airway reversibility defined as >=12% and >=200 milliliter
(mL) increase in FEV1 between 20 and 60 minutes following 4 inhalations of
albuterol/salbutamol aerosol at Visit 1.
- If the subject does not meet the above reversibility criteria at Visit 1 then the
reversibility assessment may be repeated once within 7 days of Visit 1 if either
criteria a) or b) are met: a) >=9% increase in FEV1 between 20 and 60 minutes
following 4 inhalations of albuterol/salbutamol aerosol at Visit 1. b) Documented
evidence of a reversibility assessment within 1 year prior to Visit 1 which
demonstrated a post-bronchodilator increase in FEV1 of >=12% and >=200 mL.
Should the subject successfully demonstrate airway reversibility (defined as >=12% and
>=200 mL increase in FEV1 between 20 and 60 minutes following 4 inhalations of
albuterol/salbutamol aerosol) at the second attempt then, provided that all other
eligibility criteria assessed at Visit 1 are met, the subject may enter the 3-week run-in
period.
- Short-Acting beta2 Agonists (SABAs): All subjects must be able to replace their
current SABA inhaler with albuterol/salbutamol aerosol inhaler at Visit 1 as needed
for the duration of the study. Subjects must be judged capable of withholding
albuterol/salbutamol for at least 6 hours prior to study visits.
- Male or eligible Female, defined as having documentation of non-reproductive potential
or reproductive potential as follows:
A female subject is eligible to participate if she is not pregnant (as confirmed by a
negative serum human chorionic gonadotrophin (hCG) test), not lactating, is not planning on
becoming pregnant during the study and at least one of the following conditions applies:
Non-reproductive potential defined as pre-menopausal females with documented tubal ligation
or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of
bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy;
Postmenopausal defined as 12 months of spontaneous amenorrhea with an appropriate clinical
profile (e.g., age appropriate, >45 years, in the absence of hormone replacement therapy).
In questionable cases for women <60 years of age, a blood sample with simultaneous follicle
stimulating hormone and estradiol falling into the central laboratory's postmenopausal
reference range is confirmatory. Females under 60 years of age, who are on hormone
replacement therapy (HRT) and whose menopausal status is in doubt, are required to use a
highly effective method to avoid pregnancy if they wish to continue their HRT during the
study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status
prior to study enrolment. For most forms of HRT, at least 2 to 4 weeks will elapse between
the cessation of therapy and the blood draw; this interval depends on the type and dosage
of HRT. Following confirmation of their post-menopausal status, subjects can resume use of
HRT during the study without use of a highly effective method to avoid pregnancy;
Reproductive potential and agrees to follow one of the options listed in the Modified List
of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential
(FRP) from the screening visit until after the last dose of study medication and completion
of the follow-up visit. The Investigator is responsible for ensuring that subjects
understand how to properly use these methods of contraception.
- Informed Consent: Able to give written informed consent prior to participation in the
study, which will include the ability to comply with the requirements and restrictions
listed in the consent form and in this protocol. Subjects must be able to read,
comprehend, and write at a level sufficient to complete study related materials.
Exclusion Criteria for Screening
- Pneumonia: Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1.
- Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma
therapy in the 6 weeks prior to Visit 1. Note: Subjects requiring a temporary change
in asthma therapy (e.g., oral corticosteroids or increased dose of ICS) to treat an
exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1
provided that, at the Investigator's discretion, the subject's condition is stable
after they have resumed their pre-exacerbation maintenance asthma therapy (without
modification) and they are considered appropriate for enrolment into this study of up
to 12 month's duration.
- Chronic Obstructive Pulmonary Disease: Subjects with the diagnosis of chronic
obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung
Disease (GOLD) guidelines, including history of exposure to risk factors (i.e.,
especially tobacco smoke, occupational dusts and chemicals, smoke from home cooking
and heating fuels) and a post-albuterol/salbutamol FEV1/Forced Vital Capacity (FVC)
ratio of <0.70 and a post-albuterol/salbutamol FEV1 of =<70% of predicted normal
values and onset of disease >=40 years of age.
- Concurrent respiratory disorders: Subjects with current evidence of pneumonia, active
tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis,
pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
or abnormalities other than asthma.
- Risk Factors for Pne",NULL,Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24,Annualized Rate of Moderate and Severe Asthma Exacerbations;Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24;Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24;Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24;Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period;Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE;Number of Participants With Abnormal Electrocardiogram (ECG) Findings;Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24;Mean Change From Baseline in Pulse Rate at Week 24;Number of Participants With Abnormal Clinical Chemistry Values;Number of Participants With Abnormal Hematology Values,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-10-13,2016-09-12,2016-09-12,2436,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-02-04,TRUE,FALSE,TRUE
3338,NCT02912377,NA,NCT02912377,NCT: 2016-09-19 ICTRP: 2016-09-19 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosages,4,NA,zwei primäre Outcomes,NA,NA,NA,NCT: Actual 96 ICTRP: 96 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-09-23,NA,2016-09-30,2017-05-31,Interventional,Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects,"Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta® in Healthy Subjects",Completed,Phase 1,96,Actual,Cinfa Biotech,Incidence of anti-drug antibodies (ADAs);Absolute Neutrophil count (ANC),,B12019-102,Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects,"Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta® in Healthy Subjects",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). ",Phase 1,2016-09-19,2016-09-20,96,Completed,Cinfa Biotech,NULL,germany;germany;germany;germany;germany,"Biological: Neulasta, B12019;Biological: Neulasta, B12019;Biological: Neulasta, B12019;Biological: Neulasta, B12019","
Inclusion Criteria:
1. Healthy male subjects, between 18 and 55 years of age (inclusive).
2. BMI between 20.0 and 30.0 kg/m² (inclusive).
3. Weight between 60 and 100 kg (inclusive).
4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5
cigarettes (or equivalent) per day prior to study start.
5. Healthy subjects as determined by medical history, physical examination including
vital signs, ECG and clinical laboratory testing.
6. Able to comply with protocol requirements, including overnight stays, blood sample
collections as defined in the protocol and to participate in the entire trial period.
7. Subjects who are able and willing to give written informed consent.
8. Male subject and his female spouse/partner who is of childbearing potential must be
using effective contraception starting at screening and continue throughout the
clinical study period.
9. Male subject must not donate sperm starting at screening and throughout the clinical
study period and for 3 months after final study drug administration.
Exclusion Criteria:
History of:
1. Evidence in the subject's medical history or in the medical examination of any
clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,
haematological, central nervous system diseases or other significant acute or chronic
diseases, especially hereditary fructose intolerance, which might influence either the
safety of the subject or the absorption, metabolism or excretion of the active agent
under investigation.
2. Subjects with clinically relevant neurologic or psychiatric illness.
3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,
seasonal allergies at time of dosing).
4. Previous exposure to pegfilgrastim.
5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim
or any other component of B12019 or Neulasta® as listed in section 7.2.
6. History of allergy to any recombinant protein.
7. History of cancer.
8. History of haematological disease, including sickle cell disorder.
9. History of pulmonary infiltrates or pneumonia within 6 months before the first study
drug administration.
10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies
to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,
etc.).
11. Subjects not willing or able to comply with the food and beverage restrictions
(grapefruit/pomelo, starfruit, poppy seeds).
;
Inclusion Criteria:
1. Healthy male subjects, between 18 and 55 years of age (inclusive).
2. BMI between 20.0 and 30.0 kg/m² (inclusive).
3. Weight between 60 and 100 kg (inclusive).
4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5
cigarettes (or equivalent) per day prior to study start.
5. Healthy subjects as determined by medical history, physical examination including
vital signs, ECG and clinical laboratory testing.
6. Able to comply with protocol requirements, including overnight stays, blood sample
collections as defined in the protocol and to participate in the entire trial period.
7. Subjects who are able and willing to give written informed consent.
8. Male subject and his female spouse/partner who is of childbearing potential must be
using effective contraception starting at screening and continue throughout the
clinical study period.
9. Male subject must not donate sperm starting at screening and throughout the clinical
study period and for 3 months after final study drug administration.
Exclusion Criteria:
History of:
1. Evidence in the subject's medical history or in the medical examination of any
clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,
haematological, central nervous system diseases or other significant acute or chronic
diseases, especially hereditary fructose intolerance, which might influence either the
safety of the subject or the absorption, metabolism or excretion of the active agent
under investigation.
2. Subjects with clinically relevant neurologic or psychiatric illness.
3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,
seasonal allergies at time of dosing).
4. Previous exposure to pegfilgrastim.
5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim
or any other component of B12019 or Neulasta® as listed in section 7.2.
6. History of allergy to any recombinant protein.
7. History of cancer.
8. History of haematological disease, including sickle cell disorder.
9. History of pulmonary infiltrates or pneumonia within 6 months before the first study
drug administration.
10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies
to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,
etc.).
11. Subjects not willing or able to comply with the food and beverage restrictions
(grapefruit/pomelo, starfruit, poppy seeds).
;
Inclusion Criteria:
1. Healthy male subjects, between 18 and 55 years of age (inclusive).
2. BMI between 20.0 and 30.0 kg/m² (inclusive).
3. Weight between 60 and 100 kg (inclusive).
4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5
cigarettes (or equivalent) per day prior to study start.
5. Healthy subjects as determined by medical history, physical examination including
vital signs, ECG and clinical laboratory testing.
6. Able to comply with protocol requirements, including overnight stays, blood sample
collections as defined in the protocol and to participate in the entire trial period.
7. Subjects who are able and willing to give written informed consent.
8. Male subject and his female spouse/partner who is of childbearing potential must be
using effective contraception starting at screening and continue throughout the
clinical study period.
9. Male subject must not donate sperm starting at screening and throughout the clinical
study period and for 3 months after final study drug administration.
Exclusion Criteria:
History of:
1. Evidence in the subject's medical history or in the medical examination of any
clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,
haematological, central nervous system diseases or other significant acute or chronic
diseases, especially hereditary fructose intolerance, which might influence either the
safety of the subject or the absorption, metabolism or excretion of the active agent
under investigation.
2. Subjects with clinically relevant neurologic or psychiatric illness.
3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,
seasonal allergies at time of dosing).
4. Previous exposure to pegfilgrastim.
5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim
or any other component of B12019 or Neulasta® as listed in section 7.2.
6. History of allergy to any recombinant protein.
7. History of cancer.
8. History of haematological disease, including sickle cell disorder.
9. History of pulmonary infiltrates or pneumonia within 6 months before the first study
drug administration.
10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies
to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,
etc.).
11. Subjects not willing or able to comply with the food and beverage restrictions
(grapefruit/pomelo, starfruit, poppy seeds).
;
Inclusion Criteria:
1. Healthy male subjects, between 18 and 55 years of age (inclusive).
2. BMI between 20.0 and 30.0 kg/m² (inclusive).
3. Weight between 60 and 100 kg (inclusive).
4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5
cigarettes (or equivalent) per day prior to study start.
5. Healthy subjects as determined by medical history, physical examination including
vital signs, ECG and clinical laboratory testing.
6. Able to comply with protocol requirements, including overnight stays, blood sample
collections as defined in the protocol and to participate in the entire trial period.
7. Subjects who are able and willing to give written informed consent.
8. Male subject and his female spouse/partner who is of childbearing potential must be
using effective contraception starting at screening and continue throughout the
clinical study period.
9. Male subject must not donate sperm starting at screening and throughout the clinical
study period and for 3 months after final study drug administration.
Exclusion Criteria:
History of:
1. Evidence in the subject's medical history or in the medical examination of any
clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,
haematological, central nervous system diseases or other significant acute or chronic
diseases, especially hereditary fructose intolerance, which might influence either the
safety of the subject or the absorption, metabolism or excretion of the active agent
under investigation.
2. Subjects with clinically relevant neurologic or psychiatric illness.
3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,
seasonal allergies at time of dosing).
4. Previous exposure to pegfilgrastim.
5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim
or any other component of B12019 or Neulasta® as listed in section 7.2.
6. History of allergy to any recombinant protein.
7. History of cancer.
8. History of haematological disease, including sickle cell disorder.
9. History of pulmonary infiltrates or pneumonia within 6 months before the first study
drug administration.
10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies
to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,
etc.).
11. Subjects not willing or able to comply with the food and beverage restrictions
(grapefruit/pomelo, starfruit, poppy seeds).
",NULL,Incidence of anti-drug antibodies (ADAs);Absolute Neutrophil count (ANC);Incidence of anti-drug antibodies (ADAs);Absolute Neutrophil count (ANC);Incidence of anti-drug antibodies (ADAs);Absolute Neutrophil count (ANC),NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-09-30,2016-09-19,2016-09-19,96,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2017-05-17,TRUE,FALSE,FALSE
3354,NCT02908282,NA,NCT02908282,NCT: 2016-09-13 ICTRP: 2016-09-13 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,dosages not exact because they are left up to the participants,3,NA,"no AM, no metric",4,NA,no AM,NCT: Actual 81 ICTRP: 81 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Review,https://doi.org/10.3390/pharmaceutics10010028,NA,2016-09-20,NA,2016-10-31,2018-07-31,Interventional,Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye,NA,Completed,N/A,81,Actual,TRB Chemedica AG,Ocular Surface Disease Index (OSDI©) questionnaire;Tear film stability,OSDI questionnaire;Tear film stability;Visual acuity (best corrected);TearLab osmolarity test;Inflammation marker matrix metalloproteinase 9 (MMP9);Lid-parallel conjunctival fold (LIPCOF) grading;Corneal staining;Tear volume;Conjunctival staining,REMODES-DE-2015-12,Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye,,,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). ,N/A,2016-09-13,2016-10-20,81,Completed,TRB Chemedica AG,NULL,germany,Device: REMOGEN OMEGA;Device: Povidone,"
Inclusion Criteria:
- Male or female patient between 18 and 80 years of age and in good general health
condition.
- Signed written informed consent.
- Existence of moderate to severe DES symptoms defined as Break-up time (TBUT) = 10 s
(mean of 3 consecutive measurements) and OSDI questionnaire = 20.
Exclusion Criteria:
- Contraindication for the use of the products (e.g. hypersensitivity to the
constituents of the test products) or any study procedure.
- Concomitant or previous participation in a clinical investigation within the last 3
months.
- Concomitant therapies/manipulations that affect either the tear film, tear secretion
or ocular surface integrity or would alter the effect of the devices being evaluated.
- Concurrent (systemic) DES-associated diseases that are not on a stable therapy since
at least 1 month (therapy not expected to change)
- Glaucoma that is not on a stable dosage since at least 2 weeks (therapy not expected
to change)
- Any diseases or characteristics judged by the investigator to be incompatible with the
assessments and/or procedures for the study evaluation
- Pregnant or lactating females.
- Participants of childbearing age who do not use adequate methods of birth control.
- Subjects unable to understand the informed consent or having a high probability of
noncompliance to the study procedures and/or non-completion of the study according to
investigator's judgment (e.g. illiteracy, insufficient knowledge of local language).
- Subjects not capable of contracting and of understanding the nature, risks,
significance and implications of the clinical investigation and unable to form a
rational intention in the light of these facts.
",NULL,Ocular Surface Disease Index (OSDI©) questionnaire;Tear film stability,OSDI questionnaire;Tear film stability;Visual acuity (best corrected);TearLab osmolarity test;Inflammation marker matrix metalloproteinase 9 (MMP9);Lid-parallel conjunctival fold (LIPCOF) grading;Corneal staining;Tear volume;Conjunctival staining,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-10-31,2016-09-13,2016-09-13,81,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2018-08-14,TRUE,FALSE,FALSE
3381,NCT02900196,NA,NCT02900196,NCT: 2016-09-02 ICTRP: 2016-09-02 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure (definition of AAD)",3,NA,"no AM, no measure (definition)",NCT: Actual 136 ICTRP: 136 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-09-14,NA,2016-09-16,2017-08-10,Interventional,Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders,NA,Terminated,N/A,136,Actual,Danone Research,Occurrence of AAD,"Duration of AAD;Time to event of AAD;Occurrence of Clostridium difficile Associated Diarrhea;Time to event of Clostridium difficile Associated Diarrhea;Duration of Clostridium difficile Associated Diarrhea;Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting);Score of gastrointestinal symptoms",NU372,Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders,,,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). ",N/A,2016-09-02,2016-09-16,136,Terminated,Danone Research,NULL,germany,Other: 1 - Fermented dairy drink;Other: 2 - Acidified dairy drink,"
Inclusion Criteria:
- Subjects who have read and signed the Study Informed Consent Form
- Subjects positive for Helicobacter pylori infection and symptomatic due to
Helicobacter pylori infection
- Subjects with an indication, as stated by a Gastroenterologist, for the eradication of
Helicobacter pylori
Exclusion Criteria:
- Female subjects with a positive pregnancy test (based on serum test), or planning to
become pregnant during the study or breast-feeding women
- Subjects enrolled in another interventional clinical study in the last 4 weeks or in
an exclusion period following participation in another clinical trial
- Subject who have a history of alcohol abuse
- Subjects having diarrhea within the preceding 4-weeks
- Subjects with severe life-threatening illness, severe evolutive or chronic pathology
- Immune-suppressed subjects
- Subjects with benign peptic ulcer or pre-malignant or malignant lesion
- Subjects presenting with an infection of the gastrointestinal tract
- Subjects with any past severe gastro-intestinal or metabolic pathology
- Subjects with history of Helicobacter pylori eradication therapy
- Subjects with history of cardiac or renal clinically significant disease
- Subjects that have had any surgery or intervention requiring general anesthesia in the
last 4 weeks, or that have any planned
- Subjects with allergy or hypersensitivity against the medication for the eradication
of Helicobacter pylori
- Subjects taking treatments likely to interfere with the evaluation of study
parameters.
- Subjects with allergy or hypersensitivity to any component of the study products
",NULL,Occurrence of AAD,"Duration of AAD;Time to event of AAD;Occurrence of Clostridium difficile Associated Diarrhea;Time to event of Clostridium difficile Associated Diarrhea;Duration of Clostridium difficile Associated Diarrhea;Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting);Score of gastrointestinal symptoms",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-09-16,2016-09-02,2016-09-02,136,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2018-02-05,TRUE,FALSE,FALSE
3392,NCT02896192,NA,NCT02896192,NCT: 2016-08-18 ICTRP: 2016-08-18 DRKS: NA,1,1,NA,2,1,NA,NA,1,1,no dosage,2,1,"No AM, no measure, no metric; Change in kg would have been expected here, given a lack of detail, but reported was the proportion with weight loss > 10%",3,1,"No AM, no metric",NCT: Anticipated 10 ICTRP: 10 DRKS: NA,10,1,0,NA,NA,conflicting information about blinding: quadruple or open.,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/S2213-8587(20)30364-8,2020-10-30,2016-09-12,NA,2017-02-14,2020-07-16,Interventional,Setmelanotide for the Treatment of Early-Onset POMC Deficiency Obesity,"An Open Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of RM-493, a MC4R Agonist, in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation",Completed,Phase 2/Phase 3,15,Actual,"Rhythm Pharmaceuticals, Inc.",Effect on weight loss,Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability];Effect on Body Fat Mass;Effect on Hunger;Improvements in insulin resistance;Effect on Waist Circumference;Reversal of weight during the double-blind placebo controlled withdrawal phase,RM-493-012,Setmelanotide for the Treatment of Early-Onset POMC Deficiency Obesity,"An Open Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of RM-493, a MC4R Agonist, in Early Onset POMC Deficiency Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation",,,Interventional,"Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 2/Phase 3,2016-08-18,2017-02-14,15,Completed,"Rhythm Pharmaceuticals, Inc.",NULL,united states;belgium;canada;france;germany;spain;united kingdom;belgium;canada;france;germany;spain;united kingdom;united states,Drug: Setmelanotide;Drug: Placebo,"
Inclusion Criteria:
1. Bi-allelic, homozygous or compound heterozygous (a different gene mutation on each
allele) genetic status for either the POMC or PCSK1 genes, with the loss-of-function
(LOF) variant for each allele conferring a severe obesity phenotype.
2. Age 6 years and above. 6+: US, Canada, UK, Germany, Spain, Belgium 12+:France
3. If adult age =18 years, obesity with body mass index (BMI) = 30 kg/m2; if child or
adolescent, obesity with weight > 97th percentile for age on growth chart assessment.
4. Study participant and/or parent or guardian is able to communicate well with the
investigator, to understand and comply with the requirements of the study, and be able
to understand and sign the written informed consent/assent.
5. Female participants of child-bearing potential must agree to use contraception as
outlined in the protocol. Female participants of non-childbearing potential, defined
as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral
tubal ligation) or post-menopausal for at least 12 months (and confirmed with a
screening FSH level in the post-menopausal lab range), do not require contraception
during the study.
6. Male participants with female partners of childbearing potential must agree to a
double barrier method if they become sexually active during the study. Male patients
must not donate sperm during and for 90 days following their participation in the
study.
Exclusion Criteria:
1. Recent intensive (within 2 months) diet and/or exercise regimen with or without the
use of weight loss agents including herbal medications, that has resulted in weight
loss or weight stabilization. Patients may be reconsidered approximately 1 month after
cessation of such intensive regimens.
2. Prior gastric bypass surgery resulting in >10% weight loss durably maintained from the
baseline pre-operative weight with no evidence of weight regain. Specifically,
patients may be considered if surgery was not successful, or resulted in <10% weight
loss compared to pre-operative baseline weight or clear evidence of weight regain
after an initial response to bariatric surgery. All patients with a history of
bariatric surgery must be discussed with, and receive approval from Rhythm prior to
enrollment.
3. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other Diagnostic
and Statistical Manual of Mental Disorders (DSM-III) disorders that the investigator
believes will interfere significantly with study compliance.
4. A Patient Health Questionnaire-9 (PHQ-9) score of = 15.
5. Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale
(C-SSRS). Any lifetime history of a suicide attempt, or any suicidal behavior in the
last month.
6. Current, clinically significant pulmonary, cardiac, or oncologic disease, if these
were severe enough to interfere with the study and/or would confound the results. Any
such patients should be discussed with the sponsor prior to inclusion.
7. History of significant liver disease or liver injury, or current liver assessment for
a cause of abnormal liver tests [as indicated by abnormal liver function tests,
alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase, or
serum bilirubin (> 2.0 x upper limit of normal (ULN) for any of these tests)] for an
etiology other than non-alcoholic fatty liver disease (NAFLD). Thus, any underlying
etiology besides NAFLD, including diagnosed non-alcoholic steatohepatitis (NASH),
other causes of hepatitis, or history of hepatic cirrhosis will be exclusionary, but
the presence of NAFLD would not be exclusionary.
8. History or presence of impaired renal function as indicated by clinically significant
abnormal creatinine, blood urea nitrogen (BUN), or urinary constituents (e.g.,
albuminuria) or moderate to severe renal dysfunction as defined by the Cockcroft Gault
equation < 30 mL/min (Appendix 11.10).
9. History or close family history (parents or siblings) of skin cancer or melanoma, or
patient history of ocular-cutaneous albinism.
10. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions,
determined as part of a screening comprehensive skin evaluation performed by a
qualified dermatologist. Any concerning lesions identified during the screening period
will be biopsied and results known to be benign prior to enrollment. If the
pre-treatment biopsy results are of concern, the patient may need to be excluded from
the study.
11. Volunteer is, in the opinion of the Study Investigator, not suitable to participate in
the study.
12. Participation in any clinical study with an investigational drug/device within 3
months prior to the first day of dosing.
13. Significant hypersensitivity to study drug.
14. Inability to comply with QD injection regimen.
",NULL,Effect on weight loss,Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability];Effect on Body Fat Mass;Effect on Hunger;Improvements in insulin resistance;Effect on Waist Circumference;Reversal of weight during the double-blind placebo controlled withdrawal phase,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-02-14,2016-08-18,2016-08-18,15,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2020-10-27,TRUE,FALSE,TRUE
3431,NCT02881346,NA,NCT02881346,NCT: 2016-08-23 ICTRP: 2016-08-23 DRKS: NA,1,1,NA,1,1,NA,Definition / assessment of psoriasis,NA,NA,NA,2,1,"no AM, no measure (definition of ""affected""), no metric",3,1,"no AM, no metric",NCT: Actual 410 ICTRP: 410 DRKS: NA,410,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1159/000486700,2017-12-05,2016-08-29,NA,2016-09-30,2017-03-31,Observational,Efficacy and Tolerability of Enstilar® in Daily Practice,"Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions",Completed,NA,410,Actual,LEO Pharma,Investigator Global Assessment;Percentage of total body surface area affected;Absence of related adverse events (ADR),Patient Global Assessment;PASI 50;PASI 75;Patient reported itching;Patient reported sleep loss;Patient reported erythema;Patient reported scaling;Patient reported dry skin;Patient reported overall treatment satisfaction;Patient reported satisfaction with effectiveness;Patient reported satisfaction with tolerability;Patient reported satisfaction with convenience;Dermatology Life Quality Index,NIS-ENSTILAR-1295,Efficacy and Tolerability of Enstilar® in Daily Practice,"Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions",,,Observational,,,2016-08-23,2016-09-20,410,Completed,LEO Pharma,NULL,germany,Drug: Enstilar®,"
Inclusion Criteria:
- = 18 years of age
- Psoriasis vulgaris
- Lesions on trunk and/or extremities of at least mild severity
- Treatment with Enstilar® planned
- Signed informed consent to participate
Exclusion Criteria:
- Enrolled in any interventional clinical trial
- Ongoing or recent treatment with any systemic psoriasis
- Ongoing or recent treatment with UV-therapy
- Ongoing or previous treatment with Enstilar®
- Psoriasis of scalp only
- Other forms of psoriasis, e.g. erythrodermic or pustular psoriasis
- More than 30% of surface area affected by psoriasis
- Any contraindications or known allergies to Enstilar® or its ingredients
- Incapacitated patients under institutionalized care
",NULL,Investigator Global Assessment;Percentage of total body surface area affected;Absence of related adverse events (ADR),Patient Global Assessment;PASI 50;PASI 75;Patient reported itching;Patient reported sleep loss;Patient reported erythema;Patient reported scaling;Patient reported dry skin;Patient reported overall treatment satisfaction;Patient reported satisfaction with effectiveness;Patient reported satisfaction with tolerability;Patient reported satisfaction with convenience;Dermatology Life Quality Index,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-09-30,2016-08-23,2016-08-23,410,Observational,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2019-12-12,TRUE,FALSE,FALSE
3454,NCT02873819,NA,NCT02873819,NCT: 2016-08-08 ICTRP: 2016-08-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure (identical to inclusion criteria?)",3,NA,as before,NCT: Anticipated 80 ICTRP: 80 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Review,https://doi.org/10.1080/2162402X.2018.1526250,NA,2016-08-22,NA,2017-03-30,2021-06-30,Interventional,Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma of the Oral Cavity,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients With High-Risk Squamous Cell Carcinoma of the Oral Cavity","Active, not recruiting",Phase 2,80,Actual,Gliknik Inc.,Disease-free interval,Disease-free survival (DFS);Overall survival (OS);Disease-free interval in a per protocol analysis;Adverse event profile,2016-001256-22;GL0817-01,Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma of the Oral Cavity,"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence in HLA-A2+ Patients With High-Risk Squamous Cell Carcinoma of the Oral Cavity",NULL,NULL,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2016-08-08,2017-03-30,80,"Active, not recruiting",Gliknik Inc.,NULL,united states;hungary;poland;russian federation;serbia;spain;ukraine;hungary;poland;russian federation;serbia;spain;ukraine;united states;czech republic;germany;puerto rico,Drug: GL-0817;Drug: Hiltonol;Drug: Sargramostim;Drug: cyclophosphamide;Drug: Placebo,"
Inclusion Criteria:
1. Age > 18 years
2. Histologic diagnosis of squamous cell carcinoma of the oral cavity including the lip,
floor of mouth, anterior 2/3 of tongue, alveolus and gingiva, buccal mucosa, hard
palate and retromolar trigone
3. Subjects must have undergone primary gross total resection (no re-resected patients
are allowed) with fulfillment of at least 1 of the following histologic criteria for
high-risk disease:
- Histologic involvement of 2 or more regional lymph nodes
- Any lymph node with histologic extracapsular extension (ECS)
- Close (<3mm) or positive surgical margins on microscopic evaluation with no gross
residual tumor
4. No evidence of locoregional disease or distant metastases at screening. Subjects must
have negative scans (CT, CT-PET or MRI) for locoregional recurrence, brain or lung
metastases. A negative biopsy will be mandated in patients with a positive scan. Other
evaluations should be performed as clinically indicated.
5. No history of distant metastases.
6. Tumor tissue from surgery or biopsy must be available to determine MAGE-A3 expression
for correlative studies.
7. Following surgery, the patient must have received external beam radiotherapy (58-66 Gy
in 2 Gy fractions, 5 days per week) with concomitant cisplatin starting within 8 weeks
of surgery. A brief delay in the initiation of radiotherapy following 8 weeks
post-surgery due to administrative reasons (e.g., start of RT on Mondays) may be
permitted by the Medical Monitor. The cumulative dose of cisplatin the subject
received must be > 150 mg/m2. Protocol therapy must be initiated within a period of
4-8 weeks (28-56 days) following the end of RT.
8. The patient is, in the investigator's opinion, adequately recovered from the effects
of surgery and chemoradiotherapy to participate in this study.
9. Blood HLA-A2 phenotype
10. ECOG Performance Status < 1
11. Laboratory values obtained = 14 days prior to randomization:
- Absolute neutrophil count (ANC) = 1500/µL (without intervention, e.g., G-CSF)
- Platelets = 75,000/µL (without intervention, e.g., transfusion)
- Hemoglobin = 8.0 g/dl (Note: The use of transfusion or other intervention to
achieve Hgb =8.0 g/dl is acceptable).
- Alkaline phosphatase = 2.5 x upper limit of normal (ULN)
- AST and ALT = 2 x ULN
- Creatinine < 2 x ULN
- Bilirubin < 1.5x ULN (except for patients with Gilbert's disease, for whom the
upper acceptable limit of serum bilirubin is 3mg/dL)
12. A female subject is eligible to enter the study if she is:
- not pregnant or nursing; Female participants must not breastfeed during the study
and for a period of 30 days following the last dose.
- of non-childbearing potential (i.e., women who had a hysterectomy, are
postmenopausal which is defined as 1 year without menses, have both ovaries
surgically removed or have current documented tubal ligation); or
- of childbearing potential (i.e., women with functional ovaries and no documented
impairment of oviductal or uterine function that would cause sterility). This
category includes women with oligomenorrhea [even severe], women who are
perimenopausal or have just begun to menstruate. These women must have a negative
serum pregnancy test at screening, and agree to one of the following:
- complete abstinence from intercourse from 2 weeks prior to administration of
the 1st dose of study agent and 6 months after the last dose of study agent;
or
- consistent and correct use of 1 of the following highly effective methods of
birth control for one month prior to the start of the study agent and 6
months after the last dose:
- combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal, transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, implantable)
- intrauterine device (IUD)
- intrauterine hormone-releasing system ( IUS)
- bilateral tubal occlusion
- vasectomized partner (if vasectomized is the sole sexual partner and has received
medical confirmation of surgical success)
13. A male subject who is sexually active with a woman of childbearing potential is
eligible to enter the study if he agrees to use effective contraception throughout the
study and for 6 months after the last dose of study agent.
14. The subject must be capable of understanding the investigational nature, potential
risks and benefits of the study and capable of providing valid informed consent. The
subject must provide study specific informed consent prior to any protocol procedures
that are not a part of standard care, including consent for assessment of HLA-A2
status, mandatory tissue submission for MAGE-A3 analysis and correlative studies.
15. The subject must be willing to return to the study center for vaccinations and
study-related follow up procedures including blood and tumor collections and
completion of imaging studies as required by the protocol.
Exclusion Criteria:
1. Known HIV or hepatitis B/C infection (testing not required). Subjects who are
hepatitis C antibody positive may be enrolled if they are confirmed to have a negative
viral load at screening.
2. Subjects with active autoimmune disease or a history of autoimmune disease requiring
systemic steroids or other immunosuppressive treatment.
3. Subjects who have used systemic corticosteroids or other immunosuppressants for any
condition within 14 days of randomization. Inhaled or topical steroids are permitted.
4. Any medical condition which would, in the investigator's opinion, compromise the
patient's ability to mount an immune response, renders the patient a poor candidate
for this trial or could confound the results of the study
5. Major surgery or traumatic injury within 28 days of randomization
6. Prior splenectomy or organ allograft
7. Any other prior, concurrent or planned chemotherapy, immunotherapy, radiotherapy,
device, or investigational therapy for this cancer other than those specified in this
study.
8. History of other malignancy (i.e., excluding disease under study) within 3 years of
",NULL,Disease-free interval,Disease-free survival (DFS);Overall survival (OS);Disease-free interval in a per protocol analysis;Adverse event profile,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-03-30,2016-08-08,2016-08-08,80,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2020-09-23,TRUE,FALSE,TRUE
3464,NCT02871271,NA,NCT02871271,NCT: 2016-08-10 ICTRP: 2016-08-10 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage,3,NA,"no AM, no measure (definition of questionnaire)",4,NA,no AM,NCT: Anticipated 40 ICTRP: 40 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-08-18,NA,2016-11-30,2017-09-30,Interventional,Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness,Open-Label Pilot Study to Evaluate the Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness in Healthy Subjects,Withdrawn,N/A,0,Actual,InQpharm Group,Change in VAS-F parameter,Change in Bond & Lader VAS parameter;Change in Number Connection Test;Change in FAIR-2;Change in SF-12 parameter;Change in PSQ20 parameter;Change in POMS-35 parameters;Global evaluation of benefit;Adverse events;Global evaluation of tolerability,INQ/009416,Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness,Open-Label Pilot Study to Evaluate the Tolerability and Benefit of IQP-AS-121 on Fatigue and Mental Alertness in Healthy Subjects,,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2016-08-10,2016-11-20,0,Withdrawn,InQpharm Group,NULL,germany,Dietary Supplement: IQP-AS-121,"
Inclusion Criteria:
1. Caucasian males and females, 21-55 years of age
2. Body mass index (BMI) 18.5-29.9 kg/m2
3. Generally in good health without clinically significant findings at screening
4. No chronic fatigue syndrome according to the Fukuda Centres for Disease Control and
Prevention (CDC) criteria at screening
5. Subjective feeling of chronic stress and tiredness for 3-12 last months prior to
screening
6. Screening Scale of Chronic Stress (SSCS) score >18
7. Fatigue Severity Scale score >4
8. = 3 cups/portions of coffee and/or caffeine-containing food/beverages per day in the 3
last months prior to screening and during the study
9. Regular stable continuous level of daily activities
10. Regular sleep-wake cycle
11. Normal dietary habits according to investigator's judgement
12. = moderate level of physical exercise
13. Readiness to comply with study procedures, in particular:
- Consumption of the IP during the treatment period
- Filling in all questionnaires
- Keep habitual diet and level of physical exercise
14. No change in smoking habits during the study
15. Women of child-bearing potential only:
1. negative pregnancy testing (ß-HCG in urine at screening)
2. commitment to use reliable contraception methods during the entire study
Participation is based upon written informed consent form (ICF) by the
participant following written and oral information by the investigator regarding
nature, purpose, consequences and possible risks of the clinical study.
Exclusion Criteria:
1. Known sensitivity to any components of the IP
2. Any medical condition associated with tiredness (e.g. iron deficiency, hypotension
etc.)
3. History and/or presence of clinically significant disease, which per investigator's
judgement could interfere with the results of the study or the safety of the subject:
1. Psychiatric diseases, e.g. depression, schizophrenia
2. Eating disorders such as anorexia
3. Untreated or non-stabilized metabolic diseases, e.g. diabetes mellitus
4. Untreated or non-stabilized thyroid disorder
5. Untreated or non-stabilized hypertension (systolic blood pressure =140 mmHg
and/or diastolic blood pressure =90 mmHg)
6. Significant gastrointestinal diseases
7. Insomnia
8. Known bleeding disorders such as haemophilia
9. Any other known significant or serious condition / disease that renders subjects
ineligible (e.g. history of malignancy within the past 5 years prior to
screening, any clinically significant cardiovascular, renal, liver disease etc.)
4. Use of medication which in the investigator's judgement could interfere with the
results of the study (e.g. psychoactive medication, statins, proton pump inhibitors,
blood-pressure medications, antihistamines, antibiotics, diuretics) within the last 4
weeks prior to screening and during the study
5. Consumption of vitamins, nutritional supplements, supplementary balanced diet, mineral
products which in the investigator's judgement could interfere with the results of the
study within last 4 weeks prior to screening and during the study
6. Consumption of adaptogens (e.g. ginseng or Schisandra) or St. John's Wort within last
4 weeks prior to screening and during the study
7. Consumption of energy drinks during the study
8. Start of use of contraception medication during the last 3 months prior to screening
and during the study
9. Use of anticoagulants such as warfarin
10. Clinically significant deviation of laboratory parameters and/or deviations > 2 x ULN
(upper limit of normal) at screening
11. Recent or current significant stressors (e.g. active grieving)
12. Chronic pain
13. Chronic sleep deficiency (< 5 hours/night)
14. Alcohol abuse (men: =21 units/week, women: =14 units/ week; 1 unit equals
approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
15. Drug abuse
16. Participation in another study during the last 30 days prior to screening
17. Women of child-bearing potential: pregnant or breastfeeding
18. Any situation expected during the study causing acute high level of stress
19. Any other reason deemed suitable for exclusion as per investigator's judgment, e.g.
insufficient compliance with study procedures
",NULL,Change in VAS-F parameter,Change in Bond & Lader VAS parameter;Change in Number Connection Test;Change in FAIR-2;Change in SF-12 parameter;Change in PSQ20 parameter;Change in POMS-35 parameters;Global evaluation of benefit;Adverse events;Global evaluation of tolerability,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-11-30,2016-08-10,2016-08-10,0,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-02-10,TRUE,FALSE,FALSE
3513,NCT02853136,NA,NCT02853136,NCT: 2016-07-29 ICTRP: 2016-07-29 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosages,5,NA,NA,5,NA,NA,NCT: Actual 18 ICTRP: 18 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-08-02,NA,2016-08-25,2016-10-25,Interventional,Influence of Fluvoxamine on the Pharmacokinetics of BI 409306,"Influence of Fluvoxamine on the Pharmacokinetics of BI 409306 After Oral Administration (Randomized, Open-label, Two-treatment, Two-sequence, Two-period Crossover Study)",Completed,Phase 1,18,Actual,Boehringer Ingelheim,Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point;Maximum measured concentration of the analyte in plasma,Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity,2016-000752-10;1289.35,Influence of Fluvoxamine on the Pharmacokinetics of BI 409306,"Influence of Fluvoxamine on the Pharmacokinetics of BI 409306 After Oral Administration (Randomized, Open-label, Two-treatment, Two-sequence, Two-period Crossover Study)",;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1,2016-07-29,2016-08-25,18,Completed,Boehringer Ingelheim,NULL,germany;germany;germany;germany;germany,Drug: Fluvoxamine;Drug: BI 409306;Drug: BI 409306;Drug: Fluvoxamine;Drug: BI 409306;Drug: BI 409306;Drug: Fluvoxamine;Drug: BI 409306;Drug: BI 409306;Drug: Fluvoxamine;Drug: BI 409306;Drug: BI 409306,"
Inclusion criteria:
- Healthy male or female subjects according to the investigator's assessment, based on a
complete medical history including a physical examination, vital signs (BP, PR),
12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in
accordance with GCP and local legislation
- Male or female subjects who meet any of the following criteria starting from screening
until 30 days after trial completion regarding adequate contraception:
- Non-hormonal intra-uterine device in combination with condom
- Sexually abstinent
- Surgically sterilised (including hysterectomy)
- A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
questionable cases a blood sample with simultaneous levels of FSH above 40 U/L
and estradiol below 30 ng/L is confirmatory)
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) is deviating from
normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the
range of 50 to 85 bpm
- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the
investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)
- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)
- Use of drugs within 30 days prior to administration of trial medication that might
reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered
within 60 days prior to planned administration of trial medication
- Current smoker or ex-smoker who quit smoking less than 30 days prior to screening
- Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for
males)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial
medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to
administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females)
or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure,
hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance,
because considered not able to understand and comply with study requirements, or has a
condition that would not allow safe participation in the study
- History of major bleeding events (e.g. gastric bleeding, intracranial haemorrhage)
based on the investigator's judgement
- Intake of drugs that may interfere with fluvoxamine such as monoamine oxidase
inhibitors, and tizanidine.
- Intake of hormonal contraception or ovary hormone replacement therapy in female
subjects
- Subjects with a medical history of suicidal behaviour
- History of increased intraocular pressure
- Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after
study completion
- Lactation period
;
Inclusion criteria:
- Healthy male or female subjects according to the investigator's assessment, based on a
complete medical history including a physical examination, vital signs (BP, PR),
12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in
accordance with GCP and local legislation
- Male or female subjects who meet any of the following criteria starting from screening
until 30 days after trial completion regarding adequate contraception:
- Non-hormonal intra-uterine device in combination with condom
- Sexually abstinent
- Surgically sterilised (including hysterectomy)
- A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
questionable cases a blood sample with simultaneous levels of FSH above 40 U/L
and estradiol below 30 ng/L is confirmatory)
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) is deviating from
normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the
range of 50 to 85 bpm
- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the
investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)
- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)
- Use of drugs within 30 days prior to administration of trial medication that might
reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered
within 60 days prior to planned administration of trial medication
- Current smoker or ex-smoker who quit smoking less than 30 days prior to screening
- Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for
males)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial
medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to
administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females)
or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure,
hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance,
because considered not able to understand and comply with study requirements, or has a
condition that would not allow safe participation in the study
- History of major bleeding events (e.g. gastric bleeding, intracranial haemorrhage)
based on the investigator's judgement
- Intake of drugs that may interfere with fluvoxamine such as monoamine oxidase
inhibitors, and tizanidine.
- Intake of hormonal contraception or ovary hormone replacement therapy in female
subjects
- Subjects with a medical history of suicidal behaviour
- History of increased intraocular pressure
- Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after
study completion
- Lactation period
;
Inclusion criteria:
- Healthy male or female subjects according to the investigator's assessment, based on a
complete medical history including a physical examination, vital signs (BP, PR),
12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in
accordance with GCP and local legislation
- Male or female subjects who meet any of the following criteria starting from screening
until 30 days after trial completion regarding adequate contraception:
- Non-hormonal intra-uterine device in combination with condom
- Sexually abstinent
- Surgically sterilised (including hysterectomy)
- A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
questionable cases a blood sample with simultaneous levels of FSH above 40 U/L
and estradiol below 30 ng/L is confirmatory)
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) is deviating from
normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the
range of 50 to 85 bpm
- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the
investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)
- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)
- Use of drugs within 30 days prior to administration of trial medication that might
reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered
within 60 days prior to planned administration of trial medication
- Current smoker or ex-smoker who quit smoking less than 30 days prior to screening
- Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for
males)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial
medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to
administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females)
or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure,
hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance,
because considered not able to understand and comply with study requirements, or has a
condition that would not allow safe participation in the study
- History of major bleeding events (e.g. gastric bleeding, intracranial haemorrhage)
based on the investigator's judgement
- Intake of drugs that may interfere with fluvoxamine such as monoamine oxidase
inhibitors, and tizanidine.
- Intake of hormonal contraception or ovary hormone replacement therapy in female
subjects
- Subjects with a medical history of suicidal behaviour
- History of increased intraocular pressure
- Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after
study completion
- Lactation period
;
Inclusion criteria:
- Healthy male or female subjects according to the investigator's assessment, based on a
complete medical history including a physical examination, vital signs (BP, PR),
12-lead ECG, and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in
accordance with GCP and local legislation
- Male or female subjects who meet any of the following criteria starting from screening
until 30 days after trial completion regarding adequate contraception:
- Non-hormonal intra-uterine device in combination with condom
- Sexually abstinent
- Surgically sterilised (including hysterectomy)
- A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
- Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in
questionable cases a blood sample with simultaneous levels of FSH above 40 U/L
and estradiol below 30 ng/L is confirmatory)
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) is deviating from
normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the
range of 50 to 85 bpm
- Any laboratory value outside the reference range that the investigator considers to be
of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the
investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
immunological or hormonal disorders
- Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
the pharmacokinetics of the trial medication (except appendectomy and simple hernia
repair)
- Diseases of the central nervous system (including but not limited to any kind of
seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial
medication or its excipients)
- Use of drugs within 30 days prior to administration of trial medication that might
reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered
within 60 days prior to planned administration of trial medication
- Current smoker or ex-smoker who quit smoking less than 30 days prior to screening
- Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for
males)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial
medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to
administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are
repeatedly greater than 450 ms in males or repeatedly greater than 470 ms in females)
or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure,
hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance,
because considered not able to understand and comply with study requirements, or has a
condition that would not allow safe participation in the study
- History of major bleeding events (e.g. gastric bleeding, intracranial haemorrhage)
based on the investigator's judgement
- Intake of drugs that may interfere with fluvoxamine such as monoamine oxidase
inhibitors, and tizanidine.
- Intake of hormonal contraception or ovary hormone replacement therapy in female
subjects
- Subjects with a medical history of suicidal behaviour
- History of increased intraocular pressure
- Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after
study completion
- Lactation period
",NULL,Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point;Maximum measured concentration of the analyte in plasma;Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point;Maximum measured concentration of the analyte in plasma;Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point;Maximum measured concentration of the analyte in plasma,Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-08-25,2016-07-29,2016-07-29,18,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2017-06-14,TRUE,FALSE,FALSE
3520,NCT02850965,NA,NCT02850965,NCT: 2016-07-28 ICTRP: 2016-07-28 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage,5,NA,NA,5,NA,NA,NCT: Actual 318 ICTRP: 318 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-08-01,NA,2016-08-17,2018-01-17,Interventional,"Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis","Efficacy, Safety, and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial",Completed,Phase 3,318,Actual,Boehringer Ingelheim,The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16,The Percentage of Patients With a PASI 75 Response at Week 24;The Mean Percentage Improvement in PASI at Week 16;The Percentage of Patients With a Static Physician's Global Assessment (sPGA) ≤1 (Clear or Almost Clear) at Week 16;The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16;The Percentage of Patients With Drug-related Adverse Events (AEs),2016-000613-79;1297.12,"Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis","Efficacy, Safety, and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2016-07-28,2016-08-17,318,Completed,Boehringer Ingelheim,NULL,united states;czechia;estonia;germany;poland;russian federation;slovakia;ukraine;czechia;estonia;germany;poland;russian federation;slovakia;ukraine;united states;czech republic,Drug: BI 695501;Drug: Humira,"
Inclusion criteria:
- Males and females aged >=18 to =<80 years who have a diagnosis of moderate to severe
chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months
before the first administration of study drug (a self-reported diagnosis confirmed by
the investigator is acceptable), and which has been stable for the last 2 months with
no changes in morphology or significant flares at both Screening and Baseline
(Randomization):
- involved body surface area (BSA) >= 10% and
- Psoriasis Area and Severity Index (PASI) score >= 12 and
- static Physician's Global Assessment (sPGA) score of >= 3.
- Participants of reproductive potential (childbearing potential ) must be willing and
able to use highly effective methods of birth control per International Council for
Harmonization (ICH) M3 (R2) that result in a low failure rate of less than 1% per year
when used consistently and correctly during the trial and for 6 months following
completion or discontinuation from the trial medication.
- Signed and dated written informed consent in accordance with Good Clinical Practice
(GCP) and local legislation prior to admission to the trial.
- Patients who are candidates for systemic therapy.
Exclusion criteria:
- Active ongoing inflammatory diseases other than psoriasis that might confound trial
evaluations according to investigator's judgment.
- Previous treatment with more than 1 biological agent, or adalimumab or adalimumab
biosimilar. No prior biologic exposure within last 6 months of screening.
- Patients with a significant disease other than psoriasis and/or a significant
uncontrolled disease (such as, but not limited to, nervous system, renal, hepatic,
endocrine, hematological, autoimmune or gastrointestinal disorders).
- Major surgery performed within 12 weeks prior to randomization or planned within 6
months after screening, e.g., total hip replacement.
- Any documented active or suspected malignancy or history of malignancy within 5 years
prior to screening, except appropriately treated basal cell carcinoma of the skin or
in situ carcinoma of uterine cervix.
- Patients who must or wish to continue the intake of restricted medications or any drug
considered likely to interfere with the safe conduct of the trial.
- Currently enrolled in another investigational device or drug study, or less than 30
days since ending another investigational device or drug study(s), or receiving other
investigational treatment(s).
- Chronic alcohol or drug abuse
- Women who are pregnant, nursing, or who plan to become pregnant during the course of
this study or within the period at least 6 months following completion or
discontinuation from the trial.
- Forms of psoriasis (e.g., pustular, erythrodermic and guttate) other than chronic
plaque psoriasis. Drug-induced psoriasis (i.e., new onset or current exacerbation from
e.g., beta blockers or lithium).
- Primary or secondary immunodeficiency (history of, or currently active), including
known history of HIV infection or a positive HIV test at screening (per the
investigator discretion and where mandated by local authorities).
- Known chronic or relevant acute tuberculosis; no evidence of active tuberculosis.
- Known clinically significant coronary artery disease, significant cardiac arrhythmias,
moderate to severe congestive heart failure (New York Heart Association Classes III or
IV) or interstitial lung disease observed on chest X-ray.
- History of a severe allergic reaction, anaphylactic reaction, or hypersensitivity to a
previously used biological drug or its excipients.
- Positive serology for hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit;
patients who are expecting to receive any live/attenuated virus or bacterial
vaccinations during the trial or up to 3 months after the last dose of trial drug.
- Any treatment (including biologic therapies) that, in the opinion of the investigator,
may place the patient at unacceptable risk during the trial.
- Known active infection of any kind (excluding fungal infections of nail beds), any
major episode of infection requiring hospitalization or treatment with intravenous
(i.v.) anti infectives within 4 weeks of the Screening Visit
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times upper
limit of normal (ULN) at Screening.
- Hemoglobin < 8.0 g/dL at Screening.
- Platelets < 100,000/µL at Screening.
- Leukocyte count < 4000/µL at Screening.
- Creatinine clearance < 60 mL/min/1.73 m2 at Screening.
- Patients with a history of any clinically significant adverse reaction to murine or
chimeric proteins, or natural rubber and latex, including serious allergic reactions.
",NULL,The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16,The Percentage of Patients With a PASI 75 Response at Week 24;The Mean Percentage Improvement in PASI at Week 16;The Percentage of Patients With a Static Physician's Global Assessment (sPGA) =1 (Clear or Almost Clear) at Week 16;The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16;The Percentage of Patients With Drug-related Adverse Events (AEs),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-08-17,2016-07-28,2016-07-28,318,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2019-01-16,TRUE,FALSE,TRUE
3554,NCT02838004,NA,NCT02838004,NCT: 2016-07-12 ICTRP: 2016-07-12 DRKS: NA,1,1,NA,2,1,r,NA,2,1,NA,3,1,"no AM, no metric",5,1,NA,NCT: Actual 77 ICTRP: 77 DRKS: NA,77,1,NA,NA,NA,NA,NA,NA,NA,0,no indication,ganzer Artikel,https://doi.org/10.3928/1081597X-20200603-01,2020-06-03,2016-07-20,NA,2016-08-31,2017-10-31,Interventional,Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens,"An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus",Completed,N/A,77,Actual,SIFI SpA,UDVA (Uncorrected Distance Visual Acuity),Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).,PSM15,Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens,"An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus",,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). ,N/A,2016-07-12,2016-08-20,77,Completed,SIFI SpA,"Opera CRO, a TIGERMED Group Company",germany;italy;romania,Device: IOL MINI WELL READY,"
Inclusion Criteria:
- Any gender and age above 18 years.
- Refractive lens exchange (RLE) or cataract surgery.
- Healthy corneas, not treated surgically.
- Patients willing to have surgery in both eyes in a short period of time (within 2
weeks).
- Patients request to receive the IOL MINI WELL READY implant
Exclusion Criteria:
- Previous corneal surgery (i.e. pterygium, refractive surgery).
- Eye diseases determining a probable postoperative visual acuity < 20/40.
- Pseudoexfoliation.
- Abnormal pupil size and position.
- Use of contact lens 30 days before the preoperative visit.
- Corneal warpage.
- Predicted postoperative corneal astigmatism higher than 1 D.
",NULL,UDVA (Uncorrected Distance Visual Acuity),Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-08-31,2016-07-12,2016-07-12,77,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-01-13,TRUE,FALSE,FALSE
3643,NCT02812173,NA,NCT02812173,NCT: 2016-05-18 ICTRP: 2016-05-18 DRKS: NA,1,1,NA,1,NA,r,no inlcusion criteria mentioned in paper,2,1,NA,4,1,no AM,4,1,No AM; Two further secondary outcomes mentioned in paper,NCT: Actual 234 ICTRP: 234 DRKS: NA,198,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1007/s00345-020-03225-9,2020-05-02,2016-06-24,NA,2016-05-31,2018-06-30,Interventional,Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP,"Prospective, Randomized, Three-arm, Open Controlled Trial Comparing the Quality of Micturition and the Patient Comfort by Various Urinary Drainage After Robot-assisted Radical Prostatectomy (RARP)",Completed,N/A,234,Actual,St. Antonius Hospital Gronau,Urinary leakage measured by pad test in grams,Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS);Recording of complications;Urine status measured by flow cytometry;Residual urine measured by bladder scan in ml,U4DGYZXT2DBN,Postoperative Patient Comfort and Quality of Micturition in Suprapubic Tube vs. Transurethral Catheterization After RARP,"Prospective, Randomized, Three-arm, Open Controlled Trial Comparing the Quality of Micturition and the Patient Comfort by Various Urinary Drainage After Robot-assisted Radical Prostatectomy (RARP)",;,;,Interventional,Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2016-05-18,2016-05-20,234,Completed,St. Antonius Hospital Gronau,NULL,germany,Device: suprapubic tube ex 2 day;Device: suprapubic tube ex 5 day;Device: transurethral catheter ex 5 day,
Inclusion Criteria:
- Minimum age of 18 Years
- Voluntarily agreement to participate in this study
- filled in and signed Informed Consent
- release of medical records for regulatory or research purposes
- clinically organ-confined prostate cancer
- recommended and planned robot-assisted radical prostatectomy
Exclusion Criteria:
- Participation in other interventional trials that could interfere with the present
study
- International Prostate Symptom Score (IPPS) > 18
- History of radiation or chemotherapy
- History of transurethral prostate resection
- unable to provide informed consent
- unwillingness to storage and forwarding of pseudonymous data
,NULL,Urinary leakage measured by pad test in grams,Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS);Recording of complications;Urine status measured by flow cytometry;Residual urine measured by bladder scan in ml,NCT02812173; U4DGYZXT2DBN,2016-08-15,no,Prostate Cancer; Malignant neoplasm of prostate,Arm 1 Device: suprapubic tube ex 2 day; Arm 2 Device: suprapubic tube ex 5 day; Arm 3 Device: transurethral catheter ex 5 day,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Factorial,N/A,- Urinary leakage measured by pad test in grams; time frame: within the day 2 or day 5 after the surgery for 24 hours
,"- Detection of postoperative pain related to urinary drainage by numeric rating scale (NRS); time frame: once a day, first 7 days after the surgery
- Recording of complications; time frame: within the 4 weeks after surgery
- Urine status measured by flow cytometry; time frame: within the day 2 or day 5 after the surgery
- Residual urine measured by bladder scan in ml; time frame: 3 times within the day 2 or day 5 after the surgery
",Germany,[---]* Gronau,2016-05-31,NA,201,NA,- Minimum age of 18 Years
- Voluntarily agreement to participate in this study
- filled in and signed Informed Consent
- release of medical records for regulatory or research purposes
- clinically organ-confined prostate cancer
- recommended and planned robot-assisted radical prostatectomy
,- Participation in other interventional trials that could interfere with the present
study
- International Prostate Symptom Score (IPPS) > 18
- History of radiation or chemotherapy
- History of transurethral prostate resection
- unable to provide informed consent
- unwillingness to storage and forwarding of pseudonymous data
,"Prospective, Randomized, Three-arm, Open Controlled Trial Comparing the Quality of Micturition and the Patient Comfort by Various Urinary Drainage After Robot-assisted Radical Prostatectomy (RARP)",Recruiting ongoing,St. Antonius Hospital Gronau; St. Antonius Hospital Gronau; [---]*,[---]*; [---]*; katarina.urbanova@st-antonius-gronau.de,Arm 1 Device: suprapubic tube ex 2 day; Arm 2 Device: suprapubic tube ex 5 day; Arm 3 Device: transurethral catheter ex 5 day,2016-05-31,2016-05-18,2016-05-18,234,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2016,2019-01-16,TRUE,TRUE,FALSE
3652,NCT02809989,NA,NCT02809989,NCT: 2016-06-20 ICTRP: 2016-06-20 DRKS: NA,1,1,NA,1,1,NA,NA,NA,NA,no dosages (ranges),5,1,NA,5,1,NA,NCT: Actual 507 ICTRP: 507 DRKS: NA,507,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1186/s12958-020-00610-2,2020-05-26,2016-06-22,NA,2016-03-31,2018-03-13,Observational,A Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen.,"Multicentre, Prospective, Open, Non-interventional Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen in the Clinical Routine of the IVF- / ICSI-treatment.",Completed,NA,507,Actual,Teva Pharmaceutical Industries,Number of retrieved oocytes after ovarian stimulation therapy;Clinical pregnancy rate,"Number of days with administration of Ovaleap®;Administered total dose of Ovaleap®;Level of serum estradiol at the time of the last examination prior to induction of ovulation;Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation;Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist);Number of Metaphase II (MII)-oocytes;Percentage fertilisation rate;Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos;Luteal phase support (LPS): product, dose and duration of administration;User satisfaction with the Ovaleap®-pen;Baby-Take-Home-Rate (live-births).;Rate of multiple pregnancies (twins, triplets, quadruplets).;Frequency and intensity of adverse drug reactions (ADRs)",XM17-WH-40103,A Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen.,"Multicentre, Prospective, Open, Non-interventional Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen in the Clinical Routine of the IVF- / ICSI-treatment.",,,Observational,,,2016-06-20,2016-03-31,507,Completed,Teva Pharma GmbH,NULL,germany,Drug: Ovaleap®,"
Inclusion Criteria:
- Women with a medical indication for an ovarian stimulation therapy for the purposes of
an IVF or ICSI.
- First-time ovarian stimulating therapy for an IVF or ICSI.
- Ovarian stimulation therapy exclusively with Ovaleap®.
- GnRH antagonist protocol.
- Body-Mass-Index (BMI) < 30 kg/m2.
- Duration of menstrual cycle 24 - 35 days.
- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
- Combined application of IVF and ICSI
- Ovarian hyperstimulation with Ovaleap® with a consecutive social freezing.
- Polycystic ovary syndrome (PCOS).
- Endometriosis (AFS (American Fertility Society) grade 3 and 4).
- Uterine myoma (intramural > 4 cm, submucosal).
- Hydrosalpinx (on one side or both sides).
",NULL,Number of retrieved oocytes after ovarian stimulation therapy;Clinical pregnancy rate,"Number of days with administration of Ovaleap®;Administered total dose of Ovaleap®;Level of serum estradiol at the time of the last examination prior to induction of ovulation;Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation;Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist);Number of Metaphase II (MII)-oocytes;Percentage fertilisation rate;Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos;Luteal phase support (LPS): product, dose and duration of administration;User satisfaction with the Ovaleap®-pen;Baby-Take-Home-Rate (live-births).;Rate of multiple pregnancies (twins, triplets, quadruplets).;Frequency and intensity of adverse drug reactions (ADRs)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-03-31,2016-06-20,2016-06-20,507,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2016,2018-11-16,TRUE,FALSE,FALSE
3655,NCT02808975,NA,NCT02808975,NCT: 2016-06-20 ICTRP: 2016-06-20 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 206 ICTRP: 206 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-06-22,NA,2016-07-18,2019-10-16,Interventional,Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically,"A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa",Completed,Phase 4,206,Actual,AbbVie,Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12,Percentage of Participants Achieving HiSCR-es at Week 12;Percentage of Participants Achieving HiSCR-es at Week 24;Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12;Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery,2015-005161-23;M15-574,Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically,"A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 4,2016-06-20,2016-07-18,206,Completed,AbbVie,NULL,united states;belgium;canada;colombia;czechia;denmark;france;germany;greece;ireland;italy;mexico;netherlands;norway;poland;portugal;romania;russian federation;saudi arabia;spain;sweden;turkey;united kingdom;belgium;canada;colombia;czechia;denmark;france;germany;greece;ireland;italy;mexico;netherlands;norway;poland;portugal;romania;russian federation;saudi arabia;spain;sweden;turkey;united kingdom;united states,Drug: Placebo;Drug: Adalimumab,"
Inclusion Criteria:
- Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa
(HS) for at least 1 year (365 days) prior to the Baseline visit
- Participant must have at least 3 distinct anatomical regions involved with
inflammatory (also termed 'active') HS lesions; plus
- either one axilla or one inguinal region (limited to the inguino-crural fold and
adjacent areas) that requires excisional surgery, and
- with at least one of the other affected HS regions (e.g., contralateral inguinal
region, buttocks, inframammary region) rated as Hurley Stage II or III
- Participant must have a total abscess and inflammatory nodule (AN) count of greater
than or equal to 3 at the Baseline visit within the HS non-surgical sites
- The HS surgical site must contain at least one active HS lesion
- The HS surgical site must require excisional surgery and is large enough to require
healing by secondary intention as assessed by the designated surgeon
Exclusion Criteria:
- Participant has a draining fistula count of greater than 20 at the Baseline visit
- Participant requires surgery at any anatomical site other than an unilateral axilla or
inguinal region site
- Participant requires surgical management prior to Week 13
- Participant requires, based on the designated surgeon's assessment, excisional surgery
with primary closure as the method of closure being most beneficial for the
participant
",NULL,Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12,Percentage of Participants Achieving HiSCR-es at Week 12;Percentage of Participants Achieving HiSCR-es at Week 24;Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12;Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-07-18,2016-06-20,2016-06-20,206,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-05-04,TRUE,FALSE,TRUE
3748,NCT02784106,NA,NCT02784106,NCT: 2016-05-24 ICTRP: 2016-05-24 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 65 ICTRP: 65 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-05-26,NA,2016-07-31,2017-11-14,Interventional,Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis,"Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects With Rheumatoid Arthritis on Stable Methotrexate Therapy",Completed,Phase 2,65,Actual,EMD Serono,Proportion of Participants Who Achieved American College of Rheumatology-20 (ACR20) Response,"Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 28;Proportion of Participants Achieving American College of Rheumatology-50 (ACR50) Response;Proportion of Participants Achieving American College of Rheumatology-70 (ACR70) Response;Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 84;Mean Change From Baseline in Disease Activity Score Based on a 28 Joint Count High-Sensitivity C-Reactive Protein (DAS28-hsCRP) at Day 28 and 84;Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 3.2;Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 2.6;Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 28 and 84;Change From Baseline in Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody Levels at Day 28 and 84;Change From Baseline in Rheumatoid Factor (RF) at Day 28 and 84;Change From Baseline in Global Assessment of Disease Activity Based on Visual Analog Scale (VAS) Score at Day 84;Change From Baseline in Self-assessment of Pain Based on Visual Analog Scale (VAS) Score at Day 84;Change From Baseline in Self-assessment of Disability Using Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Day 84;Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on Visual Analog Scale (VAS) Score at Day 84;Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs);Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity;Number of Participants With Grade 3 or Higher Clinically Significant Abnormality for Hematology, Biochemistry, Urinalysis or Coagulation;Number of Participants With Clinically Significant Vital Signs Abnormalities;Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings;Plasma Concentration of M2951;Area Under the Concentration-Time Curve From Time Zero to 6 Hours (AUC 0-6h) of M2951;Maximum Observed Plasma Concentration (Cmax) of M2951;Plasma Concentration Observed Immediately Before Dosing on Day 29 (Cpre) of M2951;Time to Reach Maximum Plasma Concentration (Tmax) of M2951;Accumulation Ratio for Area Under the Concentration-Time Curve From Time Zero to 6 Hours (Racc [AUC0-6h]) of M2951;Accumulation Ratio for Observed Maximum Plasma Concentration (Racc [Cmax]) of M2951;Absolute Immunoglobulin Levels at Day 85;Absolute Change From Baseline in Immunoglobulin Levels at Day 85;Absolute B-Cell Levels at Day 85;Absolute Change From Baseline in B-cell Levels at Day 85",2016-000064-42;MS200527-0081,Safety and Efficacy Study of M2951 in Participants With Rheumatoid Arthritis,"Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects With Rheumatoid Arthritis on Stable Methotrexate Therapy",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2016-05-24,2016-07-31,65,Completed,"EMD Serono Research & Development Institute, Inc.","Merck KGaA, Darmstadt, Germany",united states;germany;united states,Drug: Placebo;Drug: M2951;Drug: M2951,"
Inclusion Criteria:
- Men or women 18 to 75 years of age at the time of informed consent signature
- Confirmed diagnosis of RA according to 2010 American College of Rheumatology (ACR)/The
European League Against Rheumatism (EULAR) RA classification criteria of at least 6
months duration
- Positive RF and/or anti-CCP (anti-cyclic citrullinated peptide)
- Persistently active disease defined as greater than equal to (>=) 6 swollen joints (of
66 counted) and >= 6 tender joints (of 68 counted)
- High-sensitivity C-reactive protein (hsCRP) >= 3.6 milligram per liter (mg/L)
- Treatment for >= 12 weeks with 10 to 25 mg/week MTX at a stable dose for at least 4
weeks prior to dosing with the investigational medicinal product (IMP) and maintained
throughout the trial
- Women of childbearing potential must use acceptable methods of contraception for 4
weeks prior to randomization, throughout the trial, and for 90 days after the last
dose of IMP. For the purposes of this trial
- Females who are postmenopausal (age-related amenorrhea >= 12 consecutive months and
increased follicle-stimulating hormone [FSH] greater than (>) 40 milli international
units per milliliter [mIU/mL]), or who have undergone hysterectomy or bilateral
oophorectomy are exempt from pregnancy testing. If necessary to confirm postmenopausal
status, an FSH will be drawn at Screening
- Acceptable contraception is defined as use of either 2 barrier methods (eg, female
diaphragm and male condom), or 1 barrier method in conjunction with one of the
following: spermicide, an intrauterine device, or hormonal contraceptives (implant or
oral)
- Women of childbearing potential must have a negative serum pregnancy test at the
Screening Visit and a negative urine pregnancy test at Day 1/randomization before
dosing.
Exclusion Criteria:
- Use of oral corticosteroids > 10 mg daily prednisone equivalent, use of injectable
corticosteroids, or change in dose of corticosteroids within 2 weeks prior to
Screening or during Screening
- Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within
2 weeks prior to Screening
- Treatment with tofacitinib, other Bruton's Tyrosine Kinase (BTK) inhibitors, or a
biologic disease-modifying antirheumatic drug (DMARD; eg, anti-tumor necrosis factor
alpha [anti-TNF-a], tocilizumab [anti-interleukin-6 receptor], abatacept [CTLA4-Fc]),
or other immunosuppressive drugs(sulfasalazine would be acceptable at a stable dose)
other than methotrexate within 3 months prior to Screening or during Screening
- Treatment with anti-CD20 therapy (eg, rituximab) within 12 months prior to Screening
or during Screening
- Immunologic disorder other than Rheumatoid Arthritis (RA), with the exception of
secondary Sjogren's syndrome associated with RA, and well-controlled diabetes or
thyroid disorder, or any other condition requiring oral, intravenous, intramuscular,
or intra-articular corticosteroid therapy
- Vaccination with live or live-attenuated virus vaccine within 1 month prior to
Screening
- Active, clinically significant, viral, bacterial, or fungal infection, or any major
episode of infection requiring hospitalization or treatment with parenteral
anti-infectives within 4 weeks of Screening or during Screening, or completion of oral
anti-infectives within 2 weeks before or during Screening, or a history of recurrent
infections (ie, 3 or more of the same type of infection in a 12-month rolling period).
Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus
considered by the Investigator to be sufficiently controlled would not be exclusionary
- History of or positive testing for human immunodeficiency virus (HIV), hepatitis C
antibody and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg) (+)
and/or hepatitis B core total, and/or IgM antibody (+) at Screening
- History of or current diagnosis of active tuberculosis (TB); undergoing treatment for
latent TB infection (LTBI); untreated LTBI (as determined by documented results within
3 months of the Screening Visit of a positive TB skin test with purified protein
derivative with induration >= 5 millimeter (mm), a positive QuantiFERON-TB test or
positive or borderline T-SPOT [Elispot] test); or positive QuantiFERON-TB test at
Screening. Participants with documented completed appropriate LTBI treatment would not
be excluded and are not required to be tested
- Participants with current household contacts with active TB will also be excluded
- Indeterminate QuantiFERON-TB or T-SPOT tests may be repeated once, and will be
considered positive if retest results are positive or indeterminate
- History of cancer, except adequately treated basal cell or squamous cell carcinomas of
the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in
situ/cervical intraepithelial neoplasia of the uterine cervix, unless considered cured
> 5 years
- Clinically significant abnormality on electrocardiogram (ECG), or an active infective
process or any other clinically significant abnormality on Screening chest X-ray (CXR)
taken within 4 weeks of the first dose, per Investigator opinion. If a CXR has been
taken within the previous 3 months and results are available and normal, the CXR does
not need to be carried out
- B cell (CD19) count less than (<) 50% of the lower limit of normal at Screening
- Significant cytopenia including absolute neutrophil count < 1,500/ mm^3, platelet
count < 100,000/mm^3, or absolute lymphocyte count < 1,000/mm^3
",NULL,Proportion of Participants Who Achieved American College of Rheumatology-20 (ACR20) Response,"Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 28;Proportion of Participants Achieving American College of Rheumatology-50 (ACR50) Response;Proportion of Participants Achieving American College of Rheumatology-70 (ACR70) Response;Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 84;Mean Change From Baseline in Disease Activity Score Based on a 28 Joint Count High-Sensitivity C-Reactive Protein (DAS28-hsCRP) at Day 28 and 84;Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 3.2;Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 2.6;Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 28 and 84;Change From Baseline in Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody Levels at Day 28 and 84;Change From Baseline in Rheumatoid Factor (RF) at Day 28 and 84;Change From Baseline in Global Assessment of Disease Activity Based on Visual Analog Scale (VAS) Score at Day 84;Change From Baseline in Self-assessment of Pain Based on Visual Analog Scale (VAS) Score at Day 84;Change From Baseline in Self-assessment of Disability Using Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Day 84;Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on Visual Analog Scale (VAS) Score at Day 84;Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs);Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity;Number of Participants With Grade 3 or Higher Clinically Significant Abnormality for Hematology, Biochemistry, Urinalysis or Coagulation;Number of Participants With Clinically Significant Vital Signs Abnormalities;Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings;Plasma Concentration of M2951;Area Under the Concentration-Time Curve From Time Zero to 6 Hours (AUC 0-6h) of M2951;Maximum Observed Plasma Concentration (Cmax) of M2951;Plasma Concentration Observed Immediately Before Dosing on Day 29 (Cpre) of M2951;Time to Reach Maximum Plasma Concentration (Tmax) of M2951;Accumulation Ratio for Area Under the Concentration-Time Curve From Time Zero to 6 Hours (Racc [AUC0-6h]) of M2951;Accumulation Ratio for Observed Maximum Plasma Concentration (Racc [Cmax]) of M2951;Absolute Immunoglobulin Levels at Day 85;Absolute Change From Baseline in Immunoglobulin Levels at Day 85;Absolute B-Cell Levels at Day 85;Absolute Change From Baseline in B-cell Levels at Day 85",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-07-31,2016-05-24,2016-05-24,65,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2018-06-18,TRUE,FALSE,FALSE
3750,NCT02783573,NA,NA,NCT: 2016-05-24 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 1722 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2016-05-26,NA,2016-07-01,2018-09-28,Interventional,A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia,"A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia",Terminated,Phase 3,1722,Actual,AstraZeneca,Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score,Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL);Change From Baseline in Functional Activities Questionnaire (FAQ) Score;Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score;Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score;Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage;Change From Baseline in Neuropsychiatric Inventory (NPI) Score;Change From Baseline on the Mini-Mental State Examination (MMSE);Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42;Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40;Change From Baseline in CSF Biomarker Total Tau;Change From Baseline in CSF Biomarker Phosphorylated Tau;Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan;Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan;Change From Baseline in Whole Brain Volume;Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat;Population PK: Central Volume of Distribution of Lanabecestat,I8D-MC-AZET;2015-005625-39;16024,A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia,"A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 3,2016-05-24,2016-07-01,1722,Terminated,AstraZeneca,Eli Lilly and Company,"united states;canada;china;czechia;denmark;france;germany;italy;japan;korea, republic of;mexico;netherlands;poland;portugal;russian federation;spain;taiwan;united kingdom;canada;china;czechia;denmark;france;germany;italy;japan;korea, republic of;mexico;netherlands;poland;portugal;russian federation;spain;taiwan;united kingdom;united states;belgium;czech republic",Drug: Lanabecestat;Drug: Placebo,"
Inclusion Criteria:
- Participant must meet the National Institute on Aging (NIA) and the Alzheimer's
Association (AA) (NIA-AA) criteria for probable AD dementia.
- MMSE score of 20 to 26 inclusive at screening visit.
- For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5
or 1, with the memory box score =0.5 at screening.
- Evidence of amyloid pathology.
- The participant must have a reliable study partner with whom he/she cohabits or has
regular contact.
Exclusion Criteria:
- Significant and/or current neurological disease affecting the central nervous system,
other than AD, that may affect cognition or ability to complete the study, including
but not limited to, other dementias, repetitive head trauma, serious infection of the
brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
- Participants with any current primary psychiatric diagnosis other than AD if, in the
judgment of the investigator, the psychiatric disorder or symptom is likely to
confound interpretation of drug effect, affect cognitive assessment, or affect the
participant's ability to complete the study. Participants with history of
schizophrenia or other chronic psychosis are excluded.
- Within 1 year before the screening visit or between screening and randomization, any
of the following: myocardial infarction; moderate or severe congestive heart failure,
New York Heart Association class III or IV; hospitalization for, or symptoms of,
unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known
significant structural heart disease (such as, significant valvular disease,
hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
- Congenital QT prolongation.
- Intermittent second- or third-degree atrioventricular (AV) heart block or AV
dissociation or history of ventricular tachycardia.
- A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at
screening (as determined at the investigational site).
- History of malignant cancer within the last 5 years.
- History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
- Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula;
Cockcroft and Gault 1976) at screening.
- Currently enrolled in any other clinical trial involving an investigational product or
any other type of medical research judged not to be scientifically or medically
compatible with this study.
",NULL,Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score,Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL);Change From Baseline in Functional Activities Questionnaire (FAQ) Score;Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score;Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score;Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage;Change From Baseline in Neuropsychiatric Inventory (NPI) Score;Change From Baseline on the Mini-Mental State Examination (MMSE);Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aß)1-42;Percent Change From Baseline in Concentration of CSF Biomarker Aß1-40;Change From Baseline in CSF Biomarker Total Tau;Change From Baseline in CSF Biomarker Phosphorylated Tau;Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan;Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan;Change From Baseline in Whole Brain Volume;Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat;Population PK: Central Volume of Distribution of Lanabecestat,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-07-01,2016-05-24,2016-05-24,1722,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2019-11-19,TRUE,FALSE,FALSE
3755,NCT02782858,NA,NA,NCT: 2016-05-23 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage information,4,NA,no AM,NA,NA,NA,NCT: Actual 270 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,multiple outcomes named in title that do not reflect the registered primary outcome (the only registered outcome),kein Artikel,NA,NA,2016-05-25,NA,2016-04-30,2017-12-31,Interventional,Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS,"An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis",Completed,Phase 2,270,Actual,GeNeuro SA,Cumulative number of Gd-enhancing T1 lesions in brain MRI,,2015-004059-29;GNC-003,Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS,"An International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis",NULL,NULL,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 2,2016-05-23,2016-04-20,270,Completed,GeNeuro SA,Les Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical Trials,bulgaria;croatia;czechia;estonia;germany;hungary;italy;poland;russian federation;serbia;spain;ukraine;bulgaria;croatia;czechia;estonia;germany;hungary;italy;poland;russian federation;serbia;spain;ukraine,Drug: GNbAC1;Drug: Placebo,"
Main Inclusion Criteria:
- For male or female with reproductive potential, use of reliable means of
contraception;
- RRMS according to the 2010 revised McDonald criteria;
- Disease activity characterised by at least one documented relapse within the last 12
months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within
the last 3 months;
- EDSS score < 6.0.
Main Exclusion Criteria:
- Patients suffering from Secondary Progressive MS and Primary Progressive MS at
screening;
- Pregnant and nursing women.
",NULL,Cumulative number of Gd-enhancing T1 lesions in brain MRI,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-04-30,2016-05-23,2016-05-23,270,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2016,2020-10-19,TRUE,FALSE,TRUE
3803,NCT02771535,NA,NCT02771535,NCT: 2016-04-05 ICTRP: 2016-04-05 DRKS: NA,1,1,NA,1,1,NA,No cutpoint for MINI,2,1,NA,4,1,No AM; Follow up after 3 instead of 3.5 years,5,0,Follow up after 3.5 instead of 3 years. Outcome 7 (remission rate) not reported,NCT: Actual 84 ICTRP: 84 DRKS: NA,84,1,1,1,0,NA,"Double (Investigator, Outcomes Assessor)",Single (Assessor),worse,1,NA,ganzer Artikel,https://doi.org/10.1111/bjc.12213,2018-12-16,2016-05-13,NA,2016-03-31,2017-05-31,Interventional,Long-term Efficacy of Metacognitive Training for Depression (D-MCT),Long-term Efficacy of Metacognitive Training for Depression (D-MCT): a 3-year Follow up,Completed,N/A,84,Actual,Universitätsklinikum Hamburg-Eppendorf,Hamilton Depression Rating Scale,Self-assessed depression;Dysfunctional beliefs;Dysfunctional metacognitive beliefs;Quality of life;Work status;Self-esteem;Remission rate,1027/106,Long-term Efficacy of Metacognitive Training for Depression (D-MCT),Long-term Efficacy of Metacognitive Training for Depression (D-MCT): a 3-year Follow up,;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor). ",N/A,2016-04-05,2016-03-20,84,Completed,Universitätsklinikum Hamburg-Eppendorf,NULL,germany;germany;germany;germany;germany,Behavioral: D-MCT;Behavioral: Health Training;Behavioral: D-MCT;Behavioral: Health Training;Behavioral: D-MCT;Behavioral: Health Training;Behavioral: D-MCT;Behavioral: Health Training,"
Inclusion Criteria for the current study are:
- informed consent
- intention-to-treat-sample of the study Evaluation of Metacognitive Training for
Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek
et al., in press, Psychotherapy and Psychosomatics)
- age between 18 and 65 years
- diagnosis of a single episode or recurrent major depressive disorder (MDD) or
dysthymia (verified by the MINI).
The exclusion criteria were:
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality
(Suicidal Behaviors Questionnaire-Revised = 7), intellectual disability (estimated IQ
< 70).
;
Inclusion Criteria for the current study are:
- informed consent
- intention-to-treat-sample of the study Evaluation of Metacognitive Training for
Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek
et al., in press, Psychotherapy and Psychosomatics)
- age between 18 and 65 years
- diagnosis of a single episode or recurrent major depressive disorder (MDD) or
dysthymia (verified by the MINI).
The exclusion criteria were:
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality
(Suicidal Behaviors Questionnaire-Revised = 7), intellectual disability (estimated IQ
< 70).
;
Inclusion Criteria for the current study are:
- informed consent
- intention-to-treat-sample of the study Evaluation of Metacognitive Training for
Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek
et al., in press, Psychotherapy and Psychosomatics)
- age between 18 and 65 years
- diagnosis of a single episode or recurrent major depressive disorder (MDD) or
dysthymia (verified by the MINI).
The exclusion criteria were:
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality
(Suicidal Behaviors Questionnaire-Revised = 7), intellectual disability (estimated IQ
< 70).
;
Inclusion Criteria for the current study are:
- informed consent
- intention-to-treat-sample of the study Evaluation of Metacognitive Training for
Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek
et al., in press, Psychotherapy and Psychosomatics)
- age between 18 and 65 years
- diagnosis of a single episode or recurrent major depressive disorder (MDD) or
dysthymia (verified by the MINI).
The exclusion criteria were:
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality
(Suicidal Behaviors Questionnaire-Revised = 7), intellectual disability (estimated IQ
< 70).
",NULL,Hamilton Depression Rating Scale;Hamilton Depression Rating Scale;Hamilton Depression Rating Scale,Self-assessed depression;Dysfunctional beliefs;Dysfunctional metacognitive beliefs;Quality of life;Work status;Self-esteem;Remission rate,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-03-31,2016-04-05,2016-04-05,84,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2016,2017-08-02,TRUE,FALSE,FALSE
3822,NCT02765490,NA,EUCTR2015-004200-38,NCT: 2016-05-05 ICTRP: 2016-05-02 DRKS: NA,1,1,NA,1,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 365 ICTRP: 365 DRKS: NA,365,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1002/hep.30527,2019-01-28,2016-05-06,NA,2016-11-09,2017-11-16,Interventional,"Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection","A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis",Completed,Phase 2,365,Actual,"Janssen Research & Development, LLC",Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12),Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24);Number of Participants With Viral Relapse;Number of Participants With Late Viral Relapse;Percentage of Participants With On-treatment Failure;Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT),64294178HPC2001;2015-004200-38;CR108070,"Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection","A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2016-05-05,2016-11-09,365,Completed,"Janssen Research & Development, LLC",NULL,belgium;canada;germany;poland;singapore;spain;belgium;canada;germany;poland;singapore;spain;france;malaysia;netherlands;new zealand;sweden;united kingdom;vietnam,Drug: AL-335;Drug: Odalasvir;Drug: Simeprevir,"
Inclusion Criteria:
- Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
- Documented as treatment naive or experienced with a prior regimen consisting of
Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
- Absence of cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or
sexually active male
Exclusion Criteria:
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
- Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination
with pegylated interferon (PegIFN) or IFN-free
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other medical disorder including
cardiovascular conditions that may interfere with individual's treatment, assessment
or compliance with the protocol
- Pregnant or a nursing female
",NULL,Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12),Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24);Number of Participants With Viral Relapse;Number of Participants With Late Viral Relapse;Percentage of Participants With On-treatment Failure;Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-11-09,2016-05-05,2016-05-05,365,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2019-11-19,TRUE,FALSE,TRUE
3918,NCT02744638,NA,NCT02744638,NCT: 2016-03-31 ICTRP: 2016-03-31 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,4,1,no AM,NCT: Actual 36 ICTRP: 36 DRKS: NA,36,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Double,worse,1,NA,ganzer Artikel,https://doi.org/10.3920/BM2017.0018,2017-10-25,2016-04-20,NA,2015-02-28,2016-09-30,Interventional,Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis,"Double-blind, Randomized, Controlled Trial to Evaluate the Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains (L. Crispatus, L. Gasseri, L. Rhamnosus, L. Jensenii) on Bacterial Vaginosis (BV) in Adult Women",Completed,N/A,36,Actual,Clinical Research Center Kiel GmbH,Rate of BV-free woman,Alteration (G2 - G1) of Nugent Score;Alteration (G2 - G1) of symptom score based on Amsel criteria (Yes=1; No=0) and 3 (Yes=1; No=0) resulting in a score ranging from 0 to 2,DF-WCT-2014,Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis,"Double-blind, Randomized, Controlled Trial to Evaluate the Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains (L. Crispatus, L. Gasseri, L. Rhamnosus, L. Jensenii) on Bacterial Vaginosis (BV) in Adult Women",,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care",N/A,2016-03-31,2015-02-20,36,Completed,Clinical Research Center Kiel GmbH,Dairyfem R&D GmbH;University of Natural Resources and Life Sciences,germany,Other: probiotic yoghurt;Other: chemically acidified milk;Drug: Arilin,"
Inclusion Criteria:
To be enrolled, the following criteria have to be fulfilled:
1. Woman aged = 18 years with stable menstrual cycle or postmenopausal women
2. Newly diagnosed bacterial vaginosis based on Amsel criteria
3. Complies with a standard oral antibiotic treatment with Metronidazol for 7 days, 2 x
500mg/day)
4. Willing to consume for 4 weeks the study product two times daily
5. Willingness to abstain from food and supplements containing probiotics, prebiotics
and other fermented products as well as dietary supplements
6. Not in menses at the time of the first examination at the gynaecologist (G1)
7. Written informed consent
Exclusion Criteria:
1. Subjects currently enrolled in another clinical study.
2. Subjects having finished another clinical study within the last 4 weeks before
inclusion.
3. Infection caused by Chlamydia trachomatis
4. Infection caused by Neisseria gonorrhoea
5. Infection caused by Trichomonas vaginalis
6. Infection caused by Candida albicans or other mycosis
7. Leucocytes present in the vaginal smear
8. PAP-testing = 3 (anamnestically)
9. Vulvovaginal inflammation as macroscopically identified by the gynaecologist
10. Dyspareunia
11. Pregnancy and breastfeeding
12. Chemically based contraceptives (e.g. suppositories, salves, foam, gel)
13. Irregular cycles (e.g. polymenorrhoea, metrorrhagia)
14. Dysuria
15. Infection of the urinary tract
16. Chronic or sporadic abdominal pain with exception of dysmenorrhoea
17. Any ano-rectal infection, disease, surgery in the medical history or current
18. Anus praeter
19. Hypersensitivity, allergy or idiosyncratic reaction to metronidazole or any similar
active substances.
20. Hypersensitivity, allergy or idiosyncratic reaction to any component of the yoghurt
(e.g. lactose intolerance, allergy against milk protein)
21. Any disease or condition which might compromise significantly the hematopoietic,
renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular,
immunological, central nervous, dermatological or any other body system with the
exception of the conditions defined by the inclusion criteria.
22. History of hepatitis B and C
23. History of HIV infection
24. Regular medical treatment including OTC, which may have impact on the study aims
(e.g. probiotics, antibiotic drugs, laxatives etc.)
25. Major cognitive or psychiatric disorders
26. Subjects who are scheduled to undergo hospitalization during the study period
27. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian)
28. Present drug abuse or alcoholism, reformed alcoholic
29. Legal incapacity
",NULL,Rate of BV-free woman,Alteration (G2 - G1) of Nugent Score;Alteration (G2 - G1) of symptom score based on Amsel criteria (Yes=1; No=0) and 3 (Yes=1; No=0) resulting in a score ranging from 0 to 2,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-02-28,2016-03-31,2016-03-31,36,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,FALSE,NA,TRUE,2015,2016-11-16,TRUE,FALSE,FALSE
3947,NCT02737605,NA,NCT02737605,NCT: 2016-04-08 ICTRP: 2016-04-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 62 ICTRP: 62 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-04-14,NA,2016-07-01,2017-02-23,Interventional,A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants,"A Randomized, Double-Blind (Periods 1 to 3), Placebo- and Positive-Controlled, Single Dose, 4-Period, Crossover Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Subjects",Completed,Phase 1,62,Actual,"Janssen Research & Development, LLC",Mean Change From Baseline in QTc Interval;Percentage of Participants With Maximum Change From Baseline in Electrocardiogram (ECG) Morphology,Maximum Observed Plasma Concentration (Cmax);Time to Reach Maximum Observed Plasma Concentration (Tmax);Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC [0-12]);Area Under the Plasma Concentration Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast);Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]);Elimination Half-life Period (T1/2);Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Change From Baseline in Heart rate;Change From Baseline in QRS Interval;Change From Baseline in PR Interval;Change From Baseline in RR Interval,2014-004457-14;ESKETINTRD1013;CR106218,A Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Participants,"A Randomized, Double-Blind (Periods 1 to 3), Placebo- and Positive-Controlled, Single Dose, 4-Period, Crossover Study to Evaluate the Effects of Esketamine on Cardiac Repolarization in Healthy Subjects",,,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 1,2016-04-08,2016-07-01,62,Completed,"Janssen Research & Development, LLC",NULL,germany,Drug: Intranasal Esketamine;Drug: Intravenous Esketamine;Drug: Moxifloxacin;Drug: Oral Placebo;Drug: Intravenous Placebo;Drug: Intranasal Placebo,"
Inclusion Criteria:
- Signed an informed consent document indicating they understand the purpose of and
procedures required for the study and are willing to participate in the study
- Body mass index (BMI) between 18 and 30 kilogram (kg)/meter square ([m]^2)
(inclusive), and body weight not less than 50 kilogram (kg)
- Women using oral contraceptives must agree to use an additional birth control method
during the study and for 1 month after receiving the last dose of study drug or until
after the next menstrual period
- A woman of child-bearing potential, must have a negative serum beta-human chorionic
gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test on
Day -1 of the first treatment period
- A man, must agree to use an adequate contraception method as deemed appropriate by the
investigator (example, vasectomy, double-barrier, partner using effective
contraception) and to not donate sperm during the study and for 3 months after
receiving the last dose of study drug
Exclusion Criteria:
- Participant has a current diagnosis of psychotic disorder or major depressive disorder
(MDD) with psychosis, bipolar or related disorders, intellectual disability,
borderline personality disorder, or antisocial personality disorder
- Clinically significant medical illness including (but not limited to) cardiac
arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities,
significant pulmonary disease, including bronchospastic respiratory disease, diabetes
mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric
disease, infection, gastrointestinal disease, hypertension, vascular disorders, sleep
apnea, myasthenia gravis, or any other illness that the investigator considers should
exclude the participant or that could interfere with the interpretation of the study
results
- History of additional risk factors for torsade de pointes or the presence of a family
history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young
age (less than/equal to 40 years), drowning or sudden infant death syndrome in a first
degree relative (that is, biological parent, sibling, or child)
- Clinically significant abnormal values for hematology, clinical chemistry or
urinalysis at Screening or at admission to the study center for the first treatment
period as deemed appropriate by the investigator. Electrolytes (potassium, magnesium,
calcium) should be within the reference range of the laboratory
- Clinically significant abnormal physical examination, vital signs, or 12 lead
electrocardiogram (ECG) at Screening or at admission to the study center for the first
treatment period as deemed appropriate by the investigator
",NULL,Mean Change From Baseline in QTc Interval;Percentage of Participants With Maximum Change From Baseline in Electrocardiogram (ECG) Morphology,Maximum Observed Plasma Concentration (Cmax);Time to Reach Maximum Observed Plasma Concentration (Tmax);Area Under the Plasma Concentration Time Curve From Time Zero to 12 Hours (AUC [0-12]);Area Under the Plasma Concentration Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUClast);Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]);Elimination Half-life Period (T1/2);Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Change From Baseline in Heart rate;Change From Baseline in QRS Interval;Change From Baseline in PR Interval;Change From Baseline in RR Interval,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-07-01,2016-04-08,2016-04-08,62,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2018-04-10,TRUE,FALSE,FALSE
3983,NCT02728752,NA,NCT02728752,NCT: 2016-03-11 ICTRP: 2016-03-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Anticipated 94 ICTRP: 94 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-04-05,NA,2017-02-27,2019-11-05,Interventional,Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy),"Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM Study)",Completed,Phase 3,95,Actual,Octapharma,Measure the number of patients who had an increase of ≥20 points on the Total Improvement Score (TIS),Mean change from baseline (Week 0) to end of first period (Week 16) in: Total Improvement Score (TIS);Mean change from baseline (Week 0) to Week 40 in: Total Improvement Score (TIS);Mean change from baseline (Week 0) to end of first period (Week 16) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI);Mean change from end of first period (Week 16) to end of extension period (Week 40) in: Total Improvement Score (TIS);Mean change from end of first period (Week 16) to end of extension period (Week 40) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI);Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: SF-36v2 Health Survey;Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: Individual six core set measures (CSM) from Total Improvement Score (TIS);Proportion of Total Improvement Score (TIS) responders at the end of the extension period (Week 40) relative to Week 16 or Week 0,GAM10-08,Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy),"Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM Study)",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 3,2016-03-11,2017-02-27,95,Completed,Octapharma,NULL,united states;canada;czechia;germany;hungary;netherlands;poland;romania;russian federation;ukraine;canada;czechia;germany;hungary;netherlands;poland;romania;russian federation;ukraine;united states;czech republic;france,Drug: Octagam 10%;Other: Placebo,"
Inclusion Criteria:
1. Subjects with diagnosis of definite or probable DM according to the Bohan and Peter
criteria.
2. Subjects under treatment with corticosteroids and/or maximally 2 immune-suppressants
and being on stable therapy for at least 4 weeks.
3. Subjects with active disease, assessed and agreed upon by an independent adjudication
committee.
4. Manual Muscle Testing-8 (MMT-8) score <142, with at least 2 other abnormal Core Set
Measures (CSM) (Visual Analogue Scale [VAS] of patient global activity =2 cm,
physician's global disease activity =2 cm, extra-muscular activity =2 cm; at least one
muscle enzyme >1.5 times upper limit of normal, Health Assessment Questionnaire
=0.25).
5. Males or females = 18 to < 80 years of age.
6. Voluntarily given, fully informed written consent obtained from subject before any
study-related procedures are conducted.
7. Subject must be capable to understand and comply with the relevant aspects of the
study protocol.
Exclusion Criteria:
1. Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the
diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of
the cervix that has been excised and cured and at least 5 years have passed since
excision).
2. Evidence of active malignant disease or malignancies diagnosed within the previous 5
years (including hematological malignancies and solid tumors) or breast cancer
diagnosed within the previous 10 years.
3. Subjects with overlap myositis (except for overlap with Sjögren's syndrome),
connective tissue disease associated DM, inclusion body myositis, polymyositis or
drug-induced myopathy.
4. Subjects with immune-mediated necrotizing myopathy with absence of typical DM rash.
5. Subjects with generalized, severe musculoskeletal conditions other than DM that
prevent a sufficient assessment of the subject by the physician.
6. Subjects who have received IgG treatment within the last 6 months before enrolment.
7. Subjects who received blood or plasma-derived products (other than IgG) or plasma
exchange within the last 3 months before enrolment.
8. Subjects starting or planning to start a physical therapy-directed exercise regimen
during the trial.
9. Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, significant
cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease.
10. Severe liver disease, E.g. hepatitis or cirrhosis.
11. Severe kidney disease (creatinine 1.5 times above the upper limit of normal).
12. Known hepatitis B, hepatitis C or HIV infection.
13. Subjects with a history of deep vein thrombosis within the last year prior to study
enrollment or pulmonary embolism ever.
14. Body mass index =40 kg/m2.
15. Medical conditions whose symptoms and effects could alter protein catabolism and/or
IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
16. Known IgA deficiency with antibodies to IgA.
17. History of hypersensitivity, anaphylaxis or severe systemic response to
immuno-globulin, blood or plasma derived products or any component of Octagam 10%.
18. Known blood hyperviscosity, or other hypercoagulable states.
19. Subjects with a history of drug abuse within the past 5 years prior to study
enrollment.
20. Subjects unable or unwilling to understand or comply with the study protocol.
21. Participating in another interventional clinical study with investigational treatment
within 3 months prior to study enrollment.
22. Women who are breast feeding, pregnant, or planning to become pregnant, or are
unwilling to apply an effective birth control method while on study.
",NULL,Measure the number of patients who had an increase of =20 points on the Total Improvement Score (TIS),Mean change from baseline (Week 0) to end of first period (Week 16) in: Total Improvement Score (TIS);Mean change from baseline (Week 0) to Week 40 in: Total Improvement Score (TIS);Mean change from baseline (Week 0) to end of first period (Week 16) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI);Mean change from end of first period (Week 16) to end of extension period (Week 40) in: Total Improvement Score (TIS);Mean change from end of first period (Week 16) to end of extension period (Week 40) in the modified: Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI);Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: SF-36v2 Health Survey;Mean change from baseline (Week 0) to end of first period (Week 16) and extension period (Week 40) in: Individual six core set measures (CSM) from Total Improvement Score (TIS);Proportion of Total Improvement Score (TIS) responders at the end of the extension period (Week 40) relative to Week 16 or Week 0,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-02-27,2016-03-11,2016-03-11,95,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,2020-02-25,TRUE,FALSE,TRUE
3991,NCT02727413,NA,NCT02727413,NCT: 2016-03-23 ICTRP: 2016-03-23 DRKS: NA,1,1,NA,1,1,NA,definition of criteria missing,NA,NA,NA,5,1,NA,5,1,NA,NCT: Actual 40 ICTRP: 40 DRKS: NA,40,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1371/journal.pone.0228286,2020-02-03,2016-04-04,NA,2016-06-30,2017-02-28,Observational,Inflammatory Mediator Profiles During Heart Valve Replacement Surgery,Inflammatory and Vasoactive Mediator Profiles and Pathogen Characterization During Heart Valve Replacement Surgery,Completed,NA,40,Actual,Jena University Hospital,Area under the plasma concentration versus time curve (AUC) of C-reactive Protein (CRP);Area under the plasma concentration versus time curve (AUC) of Endothelin 1;Area under the plasma concentration versus time curve (AUC) of Procalcitonin;Area under the plasma concentration versus time curve (AUC) of Tumor Necrosis Factor (TNF) alpha;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 1beta;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 6;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 10;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 18,Area under the plasma concentration versus time curve (AUC) of pro-Adrenomedullin;Area under the plasma concentration versus time curve (AUC) of pro-Arginine vasopressin;Area under the plasma concentration versus time curve (AUC) of pro-Atrial natriuretic peptide;SOFA Score;Renal replacement therapy;Concomitant medication;In-hospital mortality,ZKS0071,Inflammatory Mediator Profiles During Heart Valve Replacement Surgery,Inflammatory and Vasoactive Mediator Profiles and Pathogen Characterization During Heart Valve Replacement Surgery,,,Observational,,,2016-03-23,2016-06-20,40,Completed,Jena University Hospital,Thermo Fisher Scientific,germany,Procedure: Blood sample collection;Other: Assessment of signs of organ dysfunction,
Inclusion Criteria:
- signed informed consent
- age > 18
- confirmed diagnosis of infective endocarditis or valvular heart disease
- scheduled surgical Intervention with CPB use
Exclusion Criteria:
- glucocorticoid dosage above Cushing threshold
- severe neutropenia (below 1000/mm3)
- immunosuppression or immunomodulatory therapy
- pregnancy
,NULL,Area under the plasma concentration versus time curve (AUC) of Procalcitonin;Area under the plasma concentration versus time curve (AUC) of C-reactive Protein (CRP);Area under the plasma concentration versus time curve (AUC) of Endothelin 1;Area under the plasma concentration versus time curve (AUC) of Tumor Necrosis Factor (TNF) alpha;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 1beta;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 6;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 10;Area under the plasma concentration versus time curve (AUC) of Interleukin (IL) 18,Area under the plasma concentration versus time curve (AUC) of pro-Adrenomedullin;Area under the plasma concentration versus time curve (AUC) of pro-Arginine vasopressin;Area under the plasma concentration versus time curve (AUC) of pro-Atrial natriuretic peptide;SOFA Score;Renal replacement therapy;Concomitant medication;In-hospital mortality,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-06-30,2016-03-23,2016-03-23,40,Observational,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2016,2019-06-21,TRUE,FALSE,FALSE
4029,NCT02716779,NA,NA,NCT: 2016-03-18 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 68 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-03-23,NA,2007-04-30,2010-04-30,Interventional,Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection,"Randomized, Multicentric, Partially Double-Blinded Placebo-Controlled Phase II Study for Examining the Influence of Ribavirin on the Initial Virological Response With Treatment of Peginterferon Alfa-2a (40KD) and Ribavirin With a Six Week Pretreatment-Phase of Ribavirin/Placebo or PEG-Interferon Monotherapy in Treatment Naïve Patients With Chronic Hepatitis C Virus Genotype 1 Infection",Completed,Phase 2,68,Actual,Hoffmann-La Roche,Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action,Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire;Percentage of Participants With Treatment Response;Area Under the Concentration-Time Curve (AUC) of Ribavirin;Maximum Concentration (Cmax) of Ribavirin;Time to Maximum Concentration (Tmax) of Ribavirin;Area Under the Concentration-Time Curve (AUC) of PEG-IFN;Maximum Concentration (Cmax) of PEG-IFN;Time to Maximum Concentration (Tmax) of PEG-IFN;Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT);Maximum Concentration (Cmax) of GPT;Time to Maximum Concentration (Tmax) of GPT,2006-000935-86;ML19301,Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection,"Randomized, Multicentric, Partially Double-Blinded Placebo-Controlled Phase II Study for Examining the Influence of Ribavirin on the Initial Virological Response With Treatment of Peginterferon Alfa-2a (40KD) and Ribavirin With a Six Week Pretreatment-Phase of Ribavirin/Placebo or PEG-Interferon Monotherapy in Treatment Naïve Patients With Chronic Hepatitis C Virus Genotype 1 Infection",;;;,;;;,Interventional,,Phase 2,2016-03-18,2007-04-20,68,Completed,Hoffmann-La Roche,Roche Pharma AG,germany;germany;germany;germany,Drug: Pegylated Interferon (PEG-IFN) alfa-2a;Drug: Placebo;Drug: Ribavirin;Drug: Pegylated Interferon (PEG-IFN) alfa-2a;Drug: Placebo;Drug: Ribavirin;Drug: Pegylated Interferon (PEG-IFN) alfa-2a;Drug: Placebo;Drug: Ribavirin;Drug: Pegylated Interferon (PEG-IFN) alfa-2a;Drug: Placebo;Drug: Ribavirin,"
Inclusion Criteria:
- Caucasians, male or female aged between 18 and 70 years
- Indication: serological proof of a chronic hepatitis C infection with positive result
of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in
serum
- Proven HCV genotype 1 by means of the reverse hybridization assays
- Proven histological infection activity within the liver with or without proven
compensated cirrhosis within the last 24 months prior to start of the study
(Child-Pugh degree A)
- Participants without previous anti-HCV therapy
Exclusion Criteria:
- Known hypersensitivity to interferon or ribavirin or any of the other component parts
- Pregnant or nursing women, women with child bearing potential and without using a high
effective method of contraception. The urine and serum pregnancy test at visit 0 in
fertile participants or cohabitants of participants must show a negative result
- Male partners of pregnant women
- Infection with HCV genotype 2, 3, 4, 5, or 6
- Pretreatment with interferon and/or ribavirin
- Immunocompromised participants
- Treatment of systemic anti-neoplastic or immunomodulatoric medication (including
supraphysiological doses of steroids or radiation therapy) within the last 6 months
prior to the start of treatment and during the complete time interval of study
treatment
- Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis,
autoimmunohepatitis, metabolic or alcohol-related liver disease)
- Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition
after decompensation
- Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of
a cirrhosis or a transition to cirrhosis
- Ascites or esophagus varices with bleedings as documented in anamnesis
- Any medical condition that questions in the opinion of the investigator the
participant's enrollment and participation in the trial
- Hemoglobin <13 grams/deciliter (g/dl) in females and <14 g/dl in males in screening
phase
- Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or
patients which would be at a particular medical risk in case of an anemia
- Diagnosed neutropenia <1.500/microliter (mcl) or thrombocytopenia <90.000/mcl in
screening phase
;
Inclusion Criteria:
- Caucasians, male or female aged between 18 and 70 years
- Indication: serological proof of a chronic hepatitis C infection with positive result
of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in
serum
- Proven HCV genotype 1 by means of the reverse hybridization assays
- Proven histological infection activity within the liver with or without proven
compensated cirrhosis within the last 24 months prior to start of the study
(Child-Pugh degree A)
- Participants without previous anti-HCV therapy
Exclusion Criteria:
- Known hypersensitivity to interferon or ribavirin or any of the other component parts
- Pregnant or nursing women, women with child bearing potential and without using a high
effective method of contraception. The urine and serum pregnancy test at visit 0 in
fertile participants or cohabitants of participants must show a negative result
- Male partners of pregnant women
- Infection with HCV genotype 2, 3, 4, 5, or 6
- Pretreatment with interferon and/or ribavirin
- Immunocompromised participants
- Treatment of systemic anti-neoplastic or immunomodulatoric medication (including
supraphysiological doses of steroids or radiation therapy) within the last 6 months
prior to the start of treatment and during the complete time interval of study
treatment
- Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis,
autoimmunohepatitis, metabolic or alcohol-related liver disease)
- Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition
after decompensation
- Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of
a cirrhosis or a transition to cirrhosis
- Ascites or esophagus varices with bleedings as documented in anamnesis
- Any medical condition that questions in the opinion of the investigator the
participant's enrollment and participation in the trial
- Hemoglobin <13 grams/deciliter (g/dl) in females and <14 g/dl in males in screening
phase
- Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or
patients which would be at a particular medical risk in case of an anemia
- Diagnosed neutropenia <1.500/microliter (mcl) or thrombocytopenia <90.000/mcl in
screening phase
;
Inclusion Criteria:
- Caucasians, male or female aged between 18 and 70 years
- Indication: serological proof of a chronic hepatitis C infection with positive result
of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in
serum
- Proven HCV genotype 1 by means of the reverse hybridization assays
- Proven histological infection activity within the liver with or without proven
compensated cirrhosis within the last 24 months prior to start of the study
(Child-Pugh degree A)
- Participants without previous anti-HCV therapy
Exclusion Criteria:
- Known hypersensitivity to interferon or ribavirin or any of the other component parts
- Pregnant or nursing women, women with child bearing potential and without using a high
effective method of contraception. The urine and serum pregnancy test at visit 0 in
fertile participants or cohabitants of participants must show a negative result
- Male partners of pregnant women
- Infection with HCV genotype 2, 3, 4, 5, or 6
- Pretreatment with interferon and/or ribavirin
- Immunocompromised participants
- Treatment of systemic anti-neoplastic or immunomodulatoric medication (including
supraphysiological doses of steroids or radiation therapy) within the last 6 months
prior to the start of treatment and during the complete time interval of study
treatment
- Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis,
autoimmunohepatitis, metabolic or alcohol-related liver disease)
- Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition
after decompensation
- Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of
a cirrhosis or a transition to cirrhosis
- Ascites or esophagus varices with bleedings as documented in anamnesis
- Any medical condition that questions in the opinion of the investigator the
participant's enrollment and participation in the trial
- Hemoglobin <13 grams/deciliter (g/dl) in females and <14 g/dl in males in screening
phase
- Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or
patients which would be at a particular medical risk in case of an anemia
- Diagnosed neutropenia <1.500/microliter (mcl) or thrombocytopenia <90.000/mcl in
screening phase
;
Inclusion Criteria:
- Caucasians, male or female aged between 18 and 70 years
- Indication: serological proof of a chronic hepatitis C infection with positive result
of anti-Hepatitis C virus (HCV) test and detectable HCV- Ribo Nucleic Acid (RNA) in
serum
- Proven HCV genotype 1 by means of the reverse hybridization assays
- Proven histological infection activity within the liver with or without proven
compensated cirrhosis within the last 24 months prior to start of the study
(Child-Pugh degree A)
- Participants without previous anti-HCV therapy
Exclusion Criteria:
- Known hypersensitivity to interferon or ribavirin or any of the other component parts
- Pregnant or nursing women, women with child bearing potential and without using a high
effective method of contraception. The urine and serum pregnancy test at visit 0 in
fertile participants or cohabitants of participants must show a negative result
- Male partners of pregnant women
- Infection with HCV genotype 2, 3, 4, 5, or 6
- Pretreatment with interferon and/or ribavirin
- Immunocompromised participants
- Treatment of systemic anti-neoplastic or immunomodulatoric medication (including
supraphysiological doses of steroids or radiation therapy) within the last 6 months
prior to the start of treatment and during the complete time interval of study
treatment
- Chronic hepatitis due to hepatitis C virus (e.g. haemochromatosis,
autoimmunohepatitis, metabolic or alcohol-related liver disease)
- Decompensated liver cirrhosis or liver disease Child-Pugh degree B or C or condition
after decompensation
- Signs of a hepatocellular carcinoma within 2 months prior to randomization in case of
a cirrhosis or a transition to cirrhosis
- Ascites or esophagus varices with bleedings as documented in anamnesis
- Any medical condition that questions in the opinion of the investigator the
participant's enrollment and participation in the trial
- Hemoglobin <13 grams/deciliter (g/dl) in females and <14 g/dl in males in screening
phase
- Patients with an increased anemia risk (e.g. thalassemia, spherocytosis, etc.) or
patients which would be at a particular medical risk in case of an anemia
- Diagnosed neutropenia <1.500/microliter (mcl) or thrombocytopenia <90.000/mcl in
screening phase
",NULL,Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action;Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action,Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire;Percentage of Participants With Treatment Response;Area Under the Concentration-Time Curve (AUC) of Ribavirin;Maximum Concentration (Cmax) of Ribavirin;Time to Maximum Concentration (Tmax) of Ribavirin;Area Under the Concentration-Time Curve (AUC) of PEG-IFN;Maximum Concentration (Cmax) of PEG-IFN;Time to Maximum Concentration (Tmax) of PEG-IFN;Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT);Maximum Concentration (Cmax) of GPT;Time to Maximum Concentration (Tmax) of GPT,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-04-30,2016-03-18,2016-03-18,68,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2007,2016-07-20,TRUE,FALSE,TRUE
4123,NCT02205359,NA,NCT02205359,NCT: 2014-07-18 ICTRP: 2014-07-18 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Anticipated 3700 ICTRP: 3700 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,"keine Intervention, Outcome und Indikation im Titel",kein Artikel,NA,NA,2014-07-31,NA,2014-07-31,2024-09-30,Interventional,AdaptResponse Clinical Trial,AdaptResponse Clinical Trial,"Active, not recruiting",N/A,3700,Anticipated,Medtronic Cardiac Rhythm and Heart Failure,Combined endpoint of all-cause mortality and intervention for heart failure decompensation,All-cause mortality;Percent of patients with interventions for heart failure decompensation;Clinical Composite Score;Atrial fibrillation;Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ);Change in Quality of Life measured by the EQ-5D;All-cause re-admissions within 30-days after a heart failure admission,AdaptResponse,AdaptResponse Clinical Trial,AdaptResponse Clinical Trial,;,;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). ,N/A,2014-07-18,2014-07-20,3700,"Active, not recruiting",Medtronic Cardiac Rhythm and Heart Failure,NULL,"united states;australia;austria;belgium;canada;denmark;finland;france;germany;hungary;india;italy;japan;korea, republic of;mexico;netherlands;norway;portugal;puerto rico;russian federation;saudi arabia;slovakia;spain;sweden;switzerland;taiwan;united kingdom;australia;austria;belgium;canada;denmark;finland;france;germany;hungary;india;italy;japan;korea, republic of;mexico;netherlands;norway;portugal;puerto rico;russian federation;saudi arabia;slovakia;spain;sweden;switzerland;taiwan;united kingdom;united states",Device: aCRT ON;Device: aCRT OFF,"
Inclusion Criteria:
- Subject is willing to sign and date the study Patient Informed Consent Form.
- Subject is indicated for a CRT device according to local guidelines.
- Sinus Rhythm at time of enrollment
- Complete Left Bundle Branch Block (LBBB) as documented on an ECG (within 30 days prior
to enrollment). Strauss Criteria used for LBBB.
- Intrinsic, normal AV conduction as documented on an ECG by a PR interval less than or
equal to 200ms (within 30 days prior to enrollment).
- Left ventricular ejection fraction less than or equal to 35% (documented within 180
days prior to enrollment).
- NYHA class II, III or IV (documented within 30 days prior to enrollment) despite
optimal medical therapy. Optimal medical therapy is defined as maximal tolerated dose
of Beta-blockers and a therapeutic dose of ACE-I, ARB or Aldosterone Antagonist.
Exclusion Criteria:
- Subject is less than 18 years of age (or has not reached minimum age per local law).
- Subject is not expected to remain available for at least 2 years of follow-up visits.
- Subject has permanent atrial arrhythmias for which pharmacological therapy and/or
cardioversion have been unsuccessful or have not been attempted
- Subject is, or previously has been, receiving cardiac resynchronization therapy.
- Subject is currently enrolled or planning to participate in a potentially confounding
drug or device trial during the course of this study. Co-enrollment in concurrent
trials is only allowed when documented pre-approval is obtained from the Medtronic
study manager.
- Subject has unstable angina, or experienced an acute myocardial infarction (MI) or
received coronary artery revascularization (CABG) or coronary angioplasty (PTCA)
within 30 days prior to enrollment.
- Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair
or valve replacement during the course of the study.
- Subject is post heart transplant (subjects on the heart transplant list for the first
time are not excluded).
- Subject has a limited life expectancy due to non-cardiac causes that would not allow
completion of the study.
- Subject is pregnant (if required by local law, women of child-bearing potential must
undergo a pregnancy test within seven days prior to device implant).
- Subject meets any exclusion criteria required by local law.
",NULL,Combined endpoint of all-cause mortality and intervention for heart failure decompensation,All-cause mortality;Percent of patients with interventions for heart failure decompensation;Clinical Composite Score;Atrial fibrillation;Change in Quality of Life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ);Change in Quality of Life measured by the EQ-5D;All-cause re-admissions within 30-days after a heart failure admission,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-07-31,2014-07-18,2014-07-18,3700,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2014,2020-06-05,TRUE,FALSE,FALSE
4217,NCT02674386,NA,NCT02674386,NCT: 2015-11-11 ICTRP: 2015-11-11 DRKS: NA,0,NA,"Registered as interventional, but seems to be observational according to interventions",0,NA,NA,"Unclear what other studies the criteria refer to (""in a tanezumab study"", ""during the tanezumab study"")",NA,NA,NA,5,NA,NA,NA,NA,NA,NCT: Actual 154 ICTRP: 154 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,"no outcome, observational according to title but interventional according to register",Abstract,https://doi.org/10.1016/j.joca.2020.02.047,NA,2016-02-04,NA,2016-08-23,2019-07-15,Interventional,"Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement","A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT",Completed,Phase 3,154,Actual,Pfizer,Number of Participants With Surgeon's Assessment of Procedural Difficulty;Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24;Number of Participants With Post-Surgical Complications Upto Week 24;Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24;Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24;Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24;Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24;Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24;Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24;Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24;Number of Participants Who Used Concomitant Analgesic Medications,,2013-002549-12;TJR FOLLOW-UP;A4091064,"Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement","A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT",,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). ,Phase 3,2015-11-11,2016-08-23,154,Completed,Pfizer,Eli Lilly and Company,"united states;australia;canada;germany;hungary;italy;japan;lithuania;new zealand;portugal;russian federation;serbia;slovakia;spain;sweden;australia;canada;germany;hungary;italy;japan;lithuania;new zealand;portugal;russian federation;serbia;slovakia;spain;sweden;united states;austria;brazil;bulgaria;colombia;croatia;finland;france;korea, republic of;mexico;peru;philippines;poland;puerto rico;romania;taiwan;ukraine;united kingdom",Drug: Investigational Medical Product (IMP) administered in parent study,"
Inclusion Criteria:
- Personally signed and dated informed consent document.
- Randomized and treated with subcutaneous investigational product in a tanezumab study
and has completed the study or been withdrawn from the study.
- Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab
study.
- Willing and able to comply with scheduled visits and other study procedures.
Exclusion Criteria:
- None.
",NULL,Number of Participants With Surgeon's Assessment of Procedural Difficulty;Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24;Number of Participants With Post-Surgical Complications Upto Week 24;Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24;Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24;Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24;Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24;Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24;Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24;Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24;Number of Participants Who Used Concomitant Analgesic Medications,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-08-23,2015-11-11,2015-11-11,154,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-07-06,TRUE,FALSE,TRUE
4223,NCT02673697,NA,NCT02673697,NCT: 2016-01-21 ICTRP: 2016-01-21 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,5,NA,NA,NCT: Anticipated 1234 ICTRP: 1234 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,kein Outcome im Titel,Studienprotokoll,https://doi.org/10.1055/s-0038-1675847,NA,2016-02-04,NA,2016-03-22,2023-10-31,Interventional,Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement,Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease,"Active, not recruiting",N/A,1234,Anticipated,LivaNova,Freedom from MACCE,Surgical times;Normalized Consumption Index;Reduced Normalized Consumption Index;Quality of life questionnaire;Intraprocedural and periprocedural serious adverse events regardless of relationship with the device;All valve and procedure relevant serious adverse events as specified in Valve Academic Research Consortium-2 (VARC-2) guidelines;Serious device related adverse events;Freedom from MACCE;Rate of Pacemaker implantation;Echocardiographic endpoints (site-reported data);Echocardiographic endpoints in a reduced cohort of patients assessed by core lab,TPS003,Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement,Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease,;,;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2016-01-21,2016-03-22,1234,"Active, not recruiting",LivaNova,NULL,australia;austria;belgium;canada;france;germany;hungary;israel;italy;netherlands;romania;spain;turkey;united kingdom;australia;austria;belgium;canada;france;germany;hungary;israel;italy;netherlands;romania;spain;turkey;united kingdom,Device: Perceval valve;Device: other stented biological valve,"
Inclusion Criteria:
1. The subject has an indication for treatment by valve replacement with a bioprosthesis
according to the IFU, through either full sternotomy or mini-sternotomy.
2. The subject has aortic valve disease that can be treated with a commercially available
Perceval valve size, based on preoperative CT-scan.
3. The subject has:
1. critical aortic valve area defined as an initial aortic valve area of =1.0 cm2 or
aortic valve area index < 0.6 cm2/m2 AND
2. Mean gradient > 40 mmHg or Vmax > 4 m/sec by resting echocardiogram or
simultaneous pressure recordings at cardiac catheterization [or with dobutamine
stress, if subject has a left ventricular ejection fraction (LVEF) <55%] or
velocity ratio < 0.25;
4. The subject is symptomatic due to aortic stenosis with functional class of New York
Heart Association (NYHA) II or higher.
5. The subject has signed the informed consent.
6. The subject is of legal minimum age.
7. The subject will be available for postoperative follow-up beyond one year.
Exclusion Criteria:
1. The subject has a contraindication for treatment by the Perceval valve or by a
bioprosthetic aortic valve as stated in the IFU.
2. The subject has aneurismal dilation or dissection of the ascending aortic wall.
3. The subject is scheduled for concomitant procedures other than Coronary Aortic Bypass
Graft (CABG), myectomy with or without aortic annulus enlargement
4. The subject has congenital bicuspid (i.e. Sievers type 0) or unicuspid aortic valve.
5. Anatomical structures not suitable for Perceval valve such as: aortic root
enlargement, where the ratio between the diameter of the sino-tubular junction and the
annulus diameter is > 1.3.
6. The subject has a prosthetic heart valve in any position, including mitral valve
repair.
7. The subject has a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days
prior to the planned valve implant surgery.
8. The subject has active endocarditis, myocarditis, or sepsis.
9. The subject is in cardiogenic shock manifested by low cardiac output and needing
hemodynamic support.
10. The subject is allergic to nickel alloys.
11. The subject is already included in another clinical trial that could confound the
results of this clinical investigation.
",NULL,Freedom from MACCE,Surgical times;Normalized Consumption Index;Reduced Normalized Consumption Index;Quality of life questionnaire;Intraprocedural and periprocedural serious adverse events regardless of relationship with the device;All valve and procedure relevant serious adverse events as specified in Valve Academic Research Consortium-2 (VARC-2) guidelines;Serious device related adverse events;Freedom from MACCE;Rate of Pacemaker implantation;Echocardiographic endpoints (site-reported data);Echocardiographic endpoints in a reduced cohort of patients assessed by core lab,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-03-22,2016-01-21,2016-01-21,1234,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2018-10-23,TRUE,FALSE,FALSE
4246,NCT02669069,NA,NCT02669069,NCT: 2016-01-27 ICTRP: 2016-01-27 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,Description deemed sufficient,4,1,no AM,NA,NA,NA,NCT: Actual 326 ICTRP: 326 DRKS: NA,326,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Double (Participant, Outcomes Assessor)",worse,1,NA,ganzer Artikel,10.1126/scitranslmed.abb2830,2020-10-07,2016-01-29,NA,2016-06-27,2019-01-30,Interventional,Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A),Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A),Completed,N/A,326,Actual,Neuromod Devices Ltd.,Tinnitus Functional Index;Tinnitus Handicap Inventory,,TENT-A1 (Stage A1);Neuromoddevices,Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A),Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A),;,;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Device Feasibility. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",N/A,2016-01-27,2016-04-22,326,Completed,Neuromod Devices Ltd.,University Hospital Regensburg,germany;ireland;germany;ireland,Device: PS1;Device: PS2;Device: PS3,"
Inclusion Criteria:
- Aged over 18 and under 70 years of age
- The ability to read and understand English/German
- Willing and able to provide informed consent
- Willing to commit to the full duration of the study
- Have been experiencing tinnitus more than 3 months and less than 5 years
- Experiencing subjective tinnitus
- Baseline Tinnitus Handicap Inventory (THI) score between 28 and 76 points
- Baseline Minimum Masking Level (MML) between 20 and 80dBHL
- Maximum AC pure-tone audiometry hearing loss of 80dB HL at any test frequencies in the
region of 250Hz to 8kHz or 40 dB HL in the set {250,500,1k} either unilaterally or
bi-laterally
Exclusion Criteria:
- If participant has been diagnosed with objective tinnitus
- Commenced usage of hearing aid within the last 90 days
- Cases where pulsatility is the dominant feature of tinnitus
- Patients whose tinnitus cannot be masked during MML assessment
- Meniere's disease
- Significantly severe Loudness Discomfort Level (LDL), <30dB SL
- Depression or neuro-psychological condition, previously diagnosed or identified from
the State-Trait Anxiety Inventory (STAI) scores greater than 120
- Diagnosed with somatic tinnitus resulting from head or neck injury
- Temporomandibular Joint Disorder (TMJ)
- Current or previous involvement in medico-legal cases
- Pregnancy
- Oral Piercings
- Neurological conditions that may lead to loss of consciousness (e.g. epilepsy) or is
considered to be the dominant feature of the tinnitus, as assessed by audiologist or
ENT consultant
- Severe cognitive impairment based on Mini Mental State Examination (MMSE), less than
20
- Pacemakers or other electro-active implanted devices
- Have used Neuromod Devices products in the past
- Participants currently prescribed drugs for a Central Nervous System pathology, i.e.
epilepsy, Multiple Sclerosis (MS), Parkinson's, bi-polar disorder.
- The site Principal Investigator does not deem the candidate to be suitable for the
study for other reasons not listed above
- Self-reporting episodes of Auditory hallucinations
- Abnormal Otoscopy as assessed by the Audiologist, including active Otitis Media,
perforation and hearing loss that is identified as completely conductive
- Abnormal Tympanometry as assessed by the Audiologist
",NULL,Tinnitus Functional Index;Tinnitus Handicap Inventory,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-06-27,2016-01-27,2016-01-27,326,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,NA,TRUE,2016,2020-12-22,TRUE,FALSE,FALSE
4354,NCT02641782,NA,NCT02641782,NCT: 2015-12-12 ICTRP: 2015-12-12 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no AM,NCT: Actual 3 ICTRP: 3 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No Outcome in title,kein Artikel,NA,NA,2015-12-29,NA,2015-11-30,2017-01-30,Interventional,NB2013-HR German (GPOH) / Dutch (DCOG) Trial,Randomized Phase 2 Trial Comparing Experimental Immunotherapy in Recurrent High Risk Neuroblastoma Patients With Standard Immunotherapy in Patients With Recurrent and Newly Diagnosed High Risk Neuroblastoma,Terminated,Phase 2,3,Actual,University of Cologne,toxic death or relevant grade 4 toxicity,Reduction of key side effects;Maximum of antibody-related pain;Comparative pharmacokinetics,Uni-Koeln-1694,NB2013-HR German (GPOH) / Dutch (DCOG) Trial,Randomized Phase 2 Trial Comparing Experimental Immunotherapy in Recurrent High Risk Neuroblastoma Patients With Standard Immunotherapy in Patients With Recurrent and Newly Diagnosed High Risk Neuroblastoma,;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2015-12-12,2015-11-20,3,Terminated,University of Cologne,NULL,germany;germany;germany;germany;germany,Drug: antibody ch14.18;Drug: GM-CSF;Drug: IL-2 i.v.;Drug: IL-2 s.c.;Drug: Retinoic acid;Drug: antibody ch14.18;Drug: GM-CSF;Drug: IL-2 i.v.;Drug: IL-2 s.c.;Drug: Retinoic acid;Drug: antibody ch14.18;Drug: GM-CSF;Drug: IL-2 i.v.;Drug: IL-2 s.c.;Drug: Retinoic acid;Drug: antibody ch14.18;Drug: GM-CSF;Drug: IL-2 i.v.;Drug: IL-2 s.c.;Drug: Retinoic acid,"
Inclusion Criteria:
- Established diagnosis of neuroblastoma according to the international criteria (INSS)
- High risk (HR): stage 4 over 18 months of age and oncogen MYCN (MYCN) amplified
neuroblastoma of any stage and any age until 25 years (recurrent disease (Germany and
The Netherlands) after re-induction chemotherapy (+/- other modalities) or newly
diagnosed disease (only The Netherlands):
- Complete front-line treatment including induction chemotherapy, radioisotope (mIBG)
treatment, appropriate local therapy such as surgical removal and/ or local
irradiation of the primary tumor and myeloablative chemotherapy with autologous stem
cell reinfusion according to the actual guidelines of the GPOH/DCOG
- achieved response status: stable disease or better (CR, VGPR, PR, SD).
- Written informed consent of parents or guardian and - if appropriate - of the patient.
- For at least two weeks prior to start of trial medication off any standard or
experimental treatment no tumour surgery no immediate requirements for palliative
chemotherapy, radiotherapy or surgery
- The patient may have had prior central nervous system (CNS) metastases provided the
following criteria are all met:
The patient's CNS disease has been previously treated The patient's CNS disease has been
clinically stable for four weeks prior to starting this study (assessed clinically and by
MRI or CT) The patient is off steroids for four weeks prior to starting the study and will
not require them during the course of the study A patient with seizure disorders may be
enrolled if well controlled on anticonvulsants and if no seizures have occurred within a 6
week period prior to starting trial treatment
- HIV sero-negative and neither active nor chronic-replicative hepatitis B infection
- Laboratory testing: The patients should have adequate functions of the cor, lung, bone
marrow, liver, kidney
Exclusion Criteria:
;
Inclusion Criteria:
- Established diagnosis of neuroblastoma according to the international criteria (INSS)
- High risk (HR): stage 4 over 18 months of age and oncogen MYCN (MYCN) amplified
neuroblastoma of any stage and any age until 25 years (recurrent disease (Germany and
The Netherlands) after re-induction chemotherapy (+/- other modalities) or newly
diagnosed disease (only The Netherlands):
- Complete front-line treatment including induction chemotherapy, radioisotope (mIBG)
treatment, appropriate local therapy such as surgical removal and/ or local
irradiation of the primary tumor and myeloablative chemotherapy with autologous stem
cell reinfusion according to the actual guidelines of the GPOH/DCOG
- achieved response status: stable disease or better (CR, VGPR, PR, SD).
- Written informed consent of parents or guardian and - if appropriate - of the patient.
- For at least two weeks prior to start of trial medication off any standard or
experimental treatment no tumour surgery no immediate requirements for palliative
chemotherapy, radiotherapy or surgery
- The patient may have had prior central nervous system (CNS) metastases provided the
following criteria are all met:
The patient's CNS disease has been previously treated The patient's CNS disease has been
clinically stable for four weeks prior to starting this study (assessed clinically and by
MRI or CT) The patient is off steroids for four weeks prior to starting the study and will
not require them during the course of the study A patient with seizure disorders may be
enrolled if well controlled on anticonvulsants and if no seizures have occurred within a 6
week period prior to starting trial treatment
- HIV sero-negative and neither active nor chronic-replicative hepatitis B infection
- Laboratory testing: The patients should have adequate functions of the cor, lung, bone
marrow, liver, kidney
Exclusion Criteria:
;
Inclusion Criteria:
- Established diagnosis of neuroblastoma according to the international criteria (INSS)
- High risk (HR): stage 4 over 18 months of age and oncogen MYCN (MYCN) amplified
neuroblastoma of any stage and any age until 25 years (recurrent disease (Germany and
The Netherlands) after re-induction chemotherapy (+/- other modalities) or newly
diagnosed disease (only The Netherlands):
- Complete front-line treatment including induction chemotherapy, radioisotope (mIBG)
treatment, appropriate local therapy such as surgical removal and/ or local
irradiation of the primary tumor and myeloablative chemotherapy with autologous stem
cell reinfusion according to the actual guidelines of the GPOH/DCOG
- achieved response status: stable disease or better (CR, VGPR, PR, SD).
- Written informed consent of parents or guardian and - if appropriate - of the patient.
- For at least two weeks prior to start of trial medication off any standard or
experimental treatment no tumour surgery no immediate requirements for palliative
chemotherapy, radiotherapy or surgery
- The patient may have had prior central nervous system (CNS) metastases provided the
following criteria are all met:
The patient's CNS disease has been previously treated The patient's CNS disease has been
clinically stable for four weeks prior to starting this study (assessed clinically and by
MRI or CT) The patient is off steroids for four weeks prior to starting the study and will
not require them during the course of the study A patient with seizure disorders may be
enrolled if well controlled on anticonvulsants and if no seizures have occurred within a 6
week period prior to starting trial treatment
- HIV sero-negative and neither active nor chronic-replicative hepatitis B infection
- Laboratory testing: The patients should have adequate functions of the cor, lung, bone
marrow, liver, kidney
Exclusion Criteria:
;
Inclusion Criteria:
- Established diagnosis of neuroblastoma according to the international criteria (INSS)
- High risk (HR): stage 4 over 18 months of age and oncogen MYCN (MYCN) amplified
neuroblastoma of any stage and any age until 25 years (recurrent disease (Germany and
The Netherlands) after re-induction chemotherapy (+/- other modalities) or newly
diagnosed disease (only The Netherlands):
- Complete front-line treatment including induction chemotherapy, radioisotope (mIBG)
treatment, appropriate local therapy such as surgical removal and/ or local
irradiation of the primary tumor and myeloablative chemotherapy with autologous stem
cell reinfusion according to the actual guidelines of the GPOH/DCOG
- achieved response status: stable disease or better (CR, VGPR, PR, SD).
- Written informed consent of parents or guardian and - if appropriate - of the patient.
- For at least two weeks prior to start of trial medication off any standard or
experimental treatment no tumour surgery no immediate requirements for palliative
chemotherapy, radiotherapy or surgery
- The patient may have had prior central nervous system (CNS) metastases provided the
following criteria are all met:
The patient's CNS disease has been previously treated The patient's CNS disease has been
clinically stable for four weeks prior to starting this study (assessed clinically and by
MRI or CT) The patient is off steroids for four weeks prior to starting the study and will
not require them during the course of the study A patient with seizure disorders may be
enrolled if well controlled on anticonvulsants and if no seizures have occurred within a 6
week period prior to starting trial treatment
- HIV sero-negative and neither active nor chronic-replicative hepatitis B infection
- Laboratory testing: The patients should have adequate functions of the cor, lung, bone
marrow, liver, kidney
Exclusion Criteria:
",NULL,toxic death or relevant grade 4 toxicity;toxic death or relevant grade 4 toxicity;toxic death or relevant grade 4 toxicity,Reduction of key side effects;Maximum of antibody-related pain;Comparative pharmacokinetics,NCT02641782; Uni-Koeln-1694,2016-12-01,yes,Neuroblastoma; Malignant neoplasm of adrenal gland; Malignant neoplasm of retroperitoneum and peritoneum,Arm 1 Drug: antibody ch14.18; Arm 2 Drug: GM-CSF; Arm 3 Drug: IL-2 i.v.; Arm 4 Drug: IL-2 s.c.; Arm 5 Drug: Retinoic acid,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,II,"- toxic death or relevant grade 4 toxicity; time frame: up to 7 months; Relevant grade 4 toxicities are defined as ascites, adult respiratory distress syndrome, capillary leak syndrome, cytokine release syndrome, dyspnea, hypotension, motor neuropathy, sensory neuropathy.
",- Reduction of key side effects; time frame: up to 7 months; Key side effects are defined as capillary leak syndrome and cytokine release syndrome. Reduction is defined by at least 1 grade or score point or day less.
- Maximum of antibody-related pain; time frame: up to 5 months; Neuralgia (with assessment of pain duration by days requiring morphine and maximum grade of pain scores during first 2 antibody cycles) will compared between both arms.
- Comparative pharmacokinetics; time frame: up to 2 months; Maximum plasma concentration of the antibody assessed during the first 2 months of treatment.
,Germany,[---]* Cologne,2015-11-30,NA,36,NA,"- Established diagnosis of neuroblastoma according to the international criteria (INSS)
- High risk (HR): stage 4 over 18 months of age and oncogen MYCN (MYCN) amplified
neuroblastoma of any stage and any age until 25 years (recurrent disease (Germany and
The Netherlands) after re-induction chemotherapy (+/- other modalities) or newly
diagnosed disease (only The Netherlands):
- Complete front-line treatment including induction chemotherapy, radioisotope (mIBG)
treatment, appropriate local therapy such as surgical removal and/ or local
irradiation of the primary tumor and myeloablative chemotherapy with autologous stem
cell reinfusion according to the actual guidelines of the GPOH/DCOG
- achieved response status: stable disease or better (CR, VGPR, PR, SD).
- Written informed consent of parents or guardian and - if appropriate - of the
patient.
- For at least two weeks prior to start of trial medication off any standard or
experimental treatment no tumour surgery no immediate requirements for palliative
chemotherapy, radiotherapy or surgery
- The patient may have had prior central nervous system (CNS) metastases provided the
following criteria are all met:
The patient's CNS disease has been previously treated The patient's CNS disease has been
clinically stable for four weeks prior to starting this study (assessed clinically and by
MRI or CT) The patient is off steroids for four weeks prior to starting the study and will
not require them during the course of the study A patient with seizure disorders may be
enrolled if well controlled on anticonvulsants and if no seizures have occurred within a 6
week period prior to starting trial treatment
- HIV sero-negative and neither active nor chronic-replicative hepatitis B infection
- Laboratory testing: The patients should have adequate functions of the cor, lung,
bone marrow, liver, kidney
",NA,Randomized Phase 2 Trial Comparing Experimental Immunotherapy in Recurrent High Risk Neuroblastoma Patients With Standard Immunotherapy in Patients With Recurrent and Newly Diagnosed High Risk Neuroblastoma,Recruiting ongoing,University of Cologne; University of Cologne; [---]*,[---]*; [---]*; frank.berthold@uk-koeln.de,Arm 1 Drug: antibody ch14.18; Arm 2 Drug: GM-CSF; Arm 3 Drug: IL-2 i.v.; Arm 4 Drug: IL-2 s.c.; Arm 5 Drug: Retinoic acid,2015-11-30,2015-12-12,2015-12-12,3,Interventional,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2015,2017-02-01,TRUE,TRUE,TRUE
4413,NCT02631538,NA,NCT02631538,NCT: 2015-12-14 ICTRP: 2015-12-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no AM,NCT: Anticipated 79 ICTRP: 79 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2015-12-16,NA,2016-02-17,2020-06-23,Interventional,Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome,"A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome",Completed,Phase 2,86,Actual,GlaxoSmithKline,Number of participants with SAEs;Number of participants with AESIs,The European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score over time;Stimulated salivary flow over time;Oral dryness numeric response scale over time;B cell quantification within salivary gland biopsy at Week 24,2015-000400-26;201842,Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome,"A Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's Syndrome",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2015-12-14,2016-02-17,86,Completed,GlaxoSmithKline,NULL,argentina;canada;france;germany;italy;netherlands;norway;spain;sweden;united kingdom;argentina;canada;france;germany;italy;netherlands;norway;spain;sweden;united kingdom,Drug: Belimumab;Drug: Rituximab;Drug: Placebo belimumab;Drug: Placebo rituximab,"
Inclusion Criteria:
- Age >=18 years, at the time of signing the informed consent.
- Documented Primary Sjögren's Syndrome by American European Consensus Group criteria
including: either anti-Sjogren's-syndrome-related antigen A (SS-A) or
anti-Sjogren's-syndrome-related antigen B (SS-B) positive.
- Baseline unstimulated salivary flow >0.0 mL/min or evidence of glandular reserve
function (stimulated baseline salivary flow >0.05 mL/min).
- Symptomatic oral dryness (>=5/10 on subject completed numeric response scale).
- Systemically active disease, ESSDAI >=5 points.
- Male and female subjects; females of child bearing potential are eligible if using
effective contraception: Female subject is eligible to participate if she is not
pregnant (as confirmed by a negative urine human chorionic gonadotropin [hCG] test),
not lactating, and at least one of the following conditions applies:
1. Non-reproductive potential defined as: Pre-menopausal females with one of the
following: Documented tubal ligation, Documented hysteroscopic tubal occlusion
procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy,
Documented Bilateral Oophorectomy.
Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable
cases a blood sample with simultaneous follicle stimulating hormone [FSH] and
estradiol levels consistent with menopause). Females on hormone replacement
therapy (HRT) and whose menopausal status is in doubt will be required to use one
of the highly effective contraception methods if they wish to continue their HRT
during the study; otherwise, they must discontinue HRT to allow confirmation of
post-menopausal status prior to study enrolment.
2. Reproductive potential and agrees to follow one of the options in the
GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding
Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days
prior to the first dose of study medication up to Week 68 after Day 0.
- Ability to understand and comply with the protocol-required procedures and provision
of informed consent.
Exclusion Criteria:
- Diagnosis of secondary Sjögren's syndrome.
- Active life-threatening or organ-threatening complications of Sjogren's-syndrome (SS)
disease at the time of screening based on treating physician evaluation including but
not restricted to (1) vasculitis with renal, digestive, cardiac, pulmonary or central
nervous system (CNS) involvement characterized as severe, (2) active CNS or peripheral
nervous system (PNS) involvement requiring high dose steroids, (3) severe renal
involvement defined by objective measures, (4) lymphoma.
- History of major organ transplant (including hematopoietic stem cell transplant).
- History of malignancy within past 5 years (with the exception of adequately treated:
[1] cervical carcinoma Stage 1B or less, [2] non-invasive basal cell and squamous cell
skin carcinoma).
- History of infection requiring long term systemic therapy including: (1) history of
positive human immunodeficiency virus (HIV) serology, (2) positive serology for
Hepatitis C virus (HCV), (3) positive serology for Hepatitis B (HB), defined as: HB
surface antigen positive (HBsAg+) OR HB core antibody positive (HBcAb+).
- Previous serious opportunistic or atypical infections or hospitalization for treatment
of infection within 364 days of Day 0 or use of parenteral (intravenous [IV] or
intramuscular [IM]) antibacterials, antivirals, anti-fungals, or anti-parasitic agents
within 364 days of prior to Day 0.
- Patients in a severely immunocompromised state.
- History of an anaphylactic reaction to parenteral administration of contrast agents,
human or murine proteins or monoclonal antibodies.
- History of significant medical illness (or planned surgical procedure) which in the
opinion of the investigator would interfere with the study procedures and / or
assessments - including but not limited to immunoglobulin G4 (IgG4) disease or prior
head or neck irradiation.
- Severe heart failure (New York Heart Association, Class IV) or other severe,
uncontrolled cardiac disease.
- Tuberculosis (TB), defined as: prior history of TB infection; suspicion of TB
infection or current TB infection
- At risk of suicide, as indicated by a lifetime history of attempted suicide or
significant suicidal ideation over the 6 months prior to the screening visit; or, if
in the Investigator's judgment, the subject is at risk for a suicide attempt.
- Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML)
- not otherwise explained - or confirmed PML.
- Electrocardiogram (ECG) showing a clinically significant abnormality at Screening or
showing an average corrected QT using Bazett's formula (QTcB) or corrected QT using
Fridericia's formula (QTcF) interval >=450 milliseconds (msec) (>=480 msec for
subjects with a Bundle Branch Block) over 3 consecutive ECGs.
- Alanine aminotransferase (ALT) >2x upper limit of normal (ULN) and bilirubin >1.5xULN
(isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
bilirubin <35%).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Use of systemic immunosuppressive or immunomodulatory agents including methotrexate,
azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil,
mycophenolate mofetil hydrochloride, and mycophenolate sodium), mizoribine,
calcineurin inhibitors [e.g., tacrolimus, cyclosporine], sirolimus, 6-mercaptopurine,
or thalidomide within 60 days prior to Day 0.
- Have received cyclophosphamide within 180 days prior to Day 0.
- Have received anti- B lymphocyte stimulator (BLyS), anti-CD 20, anti-CD22 or anti-CD52
or any other B-cell depleting agent within 364 days prior to Day 0.
- Have received abatacept or any biologic agent within 180 day prior to Day 0 (with
exception of denosumab).
- Have received intravenous immunoglobulin (IVIG) or plasmapheresis within 90 days prior
to Day 0.
- Have received oral steroid >10 milligram (mg) prednisone equivalent/day within 30 days
prior to Day 0 or oral steroid >20 mg prednisone equivalent / day for a minimum of two
consecutive weeks within 60 days prior to Day 0. Have received ",NULL,Number of participants with SAEs;Number of participants with AESIs,The European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) score over time;Stimulated salivary flow over time;Oral dryness numeric response scale over time;B cell quantification within salivary gland biopsy at Week 24,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-02-17,2015-12-14,2015-12-14,86,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-08-17,TRUE,FALSE,TRUE
4414,NCT02631447,NA,NCT02631447,NCT: 2015-12-09 ICTRP: 2015-12-09 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 251 ICTRP: 251 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Studienprotokoll,10.1200/JCO.2017.35.15_suppl.TPS9598,NA,2015-12-16,NA,2016-11-14,2021-12-31,Interventional,Sequential Combo Immuno and Target Therapy (SECOMBIT) Study,"A Three Arms Prospective, Randomized Phase II Study to Evaluate the Best Sequential Approach With Combo Immunotherapy (Ipilimumab/Nivolumab) and Combo Target Therapy (LGX818/MEK162) in Patients With Metastatic Melanoma and BRAF Mutation","Active, not recruiting",Phase 2,251,Actual,Fondazione Melanoma Onlus,Overall Survival,Total Progression free survival;Percentage of patients alive at 2 and 3 years;;Best overall response rate (BORR);;Duration of response (DoR);;Toxicity of the investigational medicinal products (IMPs).;Quality of life and general health;3 years PFS rate,2014-004842-92;SECOMBIT,Sequential Combo Immuno and Target Therapy (SECOMBIT) Study,"A Three Arms Prospective, Randomized Phase II Study to Evaluate the Best Sequential Approach With Combo Immunotherapy (Ipilimumab/Nivolumab) and Combo Target Therapy (LGX818/MEK162) in Patients With Metastatic Melanoma and BRAF Mutation",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2015-12-09,2016-11-14,251,"Active, not recruiting",Fondazione Melanoma Onlus,Clinical Research Technology S.r.l.,austria;france;germany;greece;italy;poland;spain;sweden;switzerland;united kingdom;austria;france;germany;greece;italy;poland;spain;sweden;switzerland;united kingdom,Drug: LGX818;Drug: MEK162;Drug: Nivolumab;Drug: Ipilimumab,"
Inclusion Criteria:
1. Patients of either sex aged = 18 years;
2. Histologically confirmed stage III (unresectable) or stage IV melanoma with the BRAF
V600 mutation. Patients with mucosal melanoma (but not those with ocular melanoma) are
eligible for study participation;
3. Treatment naïve for metastatic disease patients. Previous adjuvant treatment, included
checkpoint inhibitors anti CTLA-4, anti PD-1/PDL-1 is allowed, except for stage IV (if
completed at least 6 weeks prior to randomization, and all related adverse events have
either returned to baseline or stabilized). BRAF inhibitor treatment in adjuvant
setting is not permitted.
4. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per
RECIST 1.1 criteria;
5. Presence of BRAF V600E or V600K mutation in tumor tissue prior to enrollment;
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
7. Tumor tissue from an unresectable or metastatic site of disease must be provided for
biomarker analyses. An archive sample is mandatory at the screening visit; however, a
new sample collection would be preferable;
8. Female subjects of childbearing potential must have a negative pregnancy test result
at baseline and must practice two highly effective methods of contraception for the
total study duration plus 23 weeks (i.e. 30 days plus the time required for nivolumab
to undergo five half lives) after the last dose of nivolumab and ipilimumab and 30
days after the last dose of binimetinib and encorafenib for female subjects.
Additional pregnancy testing must be performed every 6 weeks during the treatment
Combo-Immuno and every 4 weeks during the treatment Combo-Target, as well as at the
end of the systemic exposure;
9. Men who are sexually active with women of childbearing potential must practice a
reliable method of contraception for the total study duration plus 31 weeks (i.e. 80
days plus the time required for nivolumab to undergo five half lives) after the last
dose of nivolumab and ipilimumab and 90 days after the last dose of binimetinib and
encorafenib;
10. Adequate bone marrow haematological function: absolute neutrophil count (ANC) = 1.5 x
109/L AND platelet count = 100 x 109/L AND haemoglobin = 9 g/dL;
11. Adequate liver function: total bilirubin = 1.5 x upper limit of normal (ULN) AND
aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2.5 X ULN (< 5 x ULN
if liver metastases);
12. Adequate renal function: serum creatinine = 1.5 mg/dL OR creatinine clearance = 60
mL/min in males and = 50 mL/min in females (calculated according to Cockroft-Gault
formula);
13. Serum calcium levels, international normalised ratio (INR) and partial thromboplastin
time were within normal limits;
14. Life expectancy of at least 3 months;
15. Ability to understand study-related patient information and provision of written
informed consent for participation in the study.
16. Adequate electrolytes at Baseline, defined as serum potassium and magnesium levels
within institutional normal limits (Note: replacement treatment to achieve adequate
electrolytes will be allowed).
17. Adequate cardiac function:
- left ventricular ejection fraction (LVEF) = 50% as determined by a multigated
--acquisition (MUGA) scan or echocardiogram,
- QTc interval = 480 ms (preferably the mean from triplicate ECGs)
Exclusion Criteria:
1. Active brain metastases. Subjects with brain metastases are eligible if these have
been treated and there is no magnetic resonance imaging (MRI) evidence of progression
for at least 4 weeks after treatment is complete and within 28 days prior to first
dose of study drug administration. There must also be no requirement for
immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone
equivalents) for at least 2 weeks prior to study drug administration;
2. Subjects with active, known or suspected autoimmune disease;
3. Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of treatment;
4. Prior treatment for stage III (unresectable) or stage IV melanoma with an
anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1),
anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4)
antibody;
5. Female subjects who are pregnant (positive pregnancy test), breast-feeding, or who are
of childbearing potential and not practicing a reliable method of birth control;
6. Evidence of severe or uncontrolled systemic disease or any concurrent condition which
in the investigator's opinion makes it undesirable for the patient to participate in
the study, or which would jeopardize compliance with the protocol, or would interfere
with the results of the study;
7. Patients with a history of uncontrolled cardiovascular or interstitial lung disease
and evidence or risk of retinal vein occlusion or central serous retinopathy (patients
with a history of cardiovascular or interstitial lung disease and evidence or risk of
retinal vein occlusion or central serous retinopathy (past or present evidence of
rethinophaty central serous retinopathy - CSR -, occlusion of retinal - RVOo retinal
degenerative disease) or ophthalmopathy, which according to the ophthalmologic
evaluation at baseline could be considered a risk factor for CSR / RVO ( eg. cupping
of the optic disc, visual field defect, intraocular pressure - (eg: central IOP - > 21
mmHg);
8. Previous or concurrent malignancy. Exceptions: adequately treated basal cell or
squamous cell skin cancer; in situ carcinoma of the cervix, treated curatively and
without evidence of recurrence for at least 3 years prior to study entry; or other
solid tumor treated curatively, and without evidence of recurrence for at least 3
years prior to study entry
9. History of Gilbert's syndrome;
10. Inability to regularly access centre facilities for logistical or other reasons;
11. History of poor co-operation, non-compliance with medical treatment, or unreliability;
12. Participation in any interventional drug or medical device study within 30 days prior
to treatment start.
13. Positive test for human immunodeficiency virus (HIV), hepatitis B virus surface
antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating
acute or chronic in",NULL,Overall Survival,Total Progression free survival;Percentage of patients alive at 2 and 3 years;;Best overall response rate (BORR);;Duration of response (DoR);;Toxicity of the investigational medicinal products (IMPs).;Quality of life and general health;3 years PFS rate,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-11-14,2015-12-09,2015-12-09,251,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2019-06-07,TRUE,FALSE,TRUE
4426,NCT02629393,NA,NA,NCT: 2015-12-03 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage,4,NA,no AM,3,NA,"no AM, no metric",NCT: Anticipated 5 ICTRP: NA DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2015-12-14,NA,2016-05-31,2021-12-31,Interventional,"Study of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A","A Phase 2/3, Multicenter, Multinational, Open Label Study to Evaluate the Efficacy and Safety of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A",Recruiting,Phase 2/Phase 3,5,Anticipated,Origin Biosciences,"Response, defined as patients alive and able to sit upright independently for at least 30 seconds",Bayley Scales of Infant Development® - Third Edition (Bayley - III®);Pediatric Evaluation of Disability Inventory (PEDI),ALXN1101-MCD-202,"Study of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A","A Phase 2/3, Multicenter, Multinational, Open Label Study to Evaluate the Efficacy and Safety of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A",;clinicaltrials@origintx.com;,;clinicaltrials@origintx.com;,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2/Phase 3,2015-12-03,2016-05-20,5,Recruiting,Origin Biosciences,NULL,united states;france;israel;malaysia;spain;turkey;united kingdom;france;israel;malaysia;spain;turkey;united kingdom;united states;germany;italy;taiwan,Drug: ORGN001 (formerly ALXN1101),"
Patients must meet all of the following inclusion criteria to be considered for enrollment
in this study:
1. Male or female neonatal patient (1 to 28 days of age [inclusive] at the time of
ORGN001 administration, with day 1 of age corresponding to the day of birth) or infant
(29 days to <2 years of age) or child (2 to 5 years of age [inclusive]) with MoCD Type
A, previously untreated with ORGN001 or treated with ORGN001 through the EAP
2. In neonates, diagnosis of MoCD Type A, based on:
Prenatal genetic diagnosis, or Onset of clinical and/or laboratory signs and symptoms
consistent with MoCD Type A (eg, seizures, exaggerated startle response, high-pitched
cry, axial hypotonia, limb hypertonia, feeding difficulties, elevated urinary sulfite
and/or SSC, elevated xanthine in urine or blood, or low or absent uric acid in the
urine or blood) within the first 28 days after birth
3. In infants or children, diagnosis of MoCD Type A, based on:
Confirmed genetic diagnosis (genetic confirmation of the diagnosis of MoCD Type A may
be obtained after initiation of ORGN001 therapy in certain cases), biochemical
profile, and clinical presentation consistent with MoCD Type A
4. Parent or legal guardian must have signed the informed consent form (ICF) prior to any
study procedures being performed
Patients will be excluded from participating in the study if they meet any of the following
criteria:
1. Diagnosis other than MoCD Type A (may be determined after the initiation of study
drug)
2. Condition that is considered by the treating physician to be a contraindication to
therapy, including evidence of abnormalities on brain imaging not attributable to MoCD
Type A, or that might otherwise interfere with the patient's participation in the
study, pose any additional risk for the patient, or confound patient assessments
3. Antenatal and/or postnatal brain imaging prior to initiation of treatment with ORGN001
that indicates cortical or subcortical cystic encephalomalacia, clinically significant
intracranial hemorrhage, or other abnormalities on brain imaging determined by the
treating physician to be clinically significant
4. Modified Glasgow Coma Scale (mGCS) for Infants and Children score of less than 7 for
more than 24 hours (does not apply to children less than 1 day in age).
",NULL,"Response, defined as patients alive and able to sit upright independently for at least 30 seconds",Bayley Scales of Infant Development® - Third Edition (Bayley - III®);Pediatric Evaluation of Disability Inventory (PEDI),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-05-31,2015-12-03,2015-12-03,5,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-03-25,TRUE,FALSE,TRUE
4521,NCT02609828,NA,NCT02609828,NCT: 2015-10-26 ICTRP: 2015-10-26 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,NA,NCT: Anticipated 155 ICTRP: 155 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2015-11-20,NA,2015-10-28,2021-07-02,Interventional,Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy.,"A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY","Active, not recruiting",Phase 3,156,Actual,Pfizer,Change from baseline in daily average pain intensity in index bone metastasis cancer pain site,"Change from baseline in daily worst pain intensity in index bone metastasis cancer pain site;Change from baseline in daily average pain intensity in index bone metastasis cancer pain site;Change from baseline in weekly average pain intensity in non-index cancer pain sites;Change from baseline in weekly worst pain intensity in non-index cancer pain sites;Change from baseline in daily average pain intensity in non-index visceral cancer pain sites;Change from baseline in daily worst pain intensity in non-index visceral cancer pain sites;Change from baseline in Brief Pain Inventory (BPI) average pain score;Change from baseline in BPI worst pain score;Response as defined by a 30%, 50%, 70%, and 90% reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site;Change from baseline in Patient's Global Assessment of Cancer Pain;Response defined as an improvement of 2 points in Patient's Global Assessment of Cancer Pain;Change from baseline in the BPI Pain Interference with Function composite score and individual pain interference item scores;EuroQol 5 Dimension (EQ-5D-5L) dimensions and overall health utility score;Average daily total opioid consumption (in mg of morphine equivalent doses);Average number of doses of rescue medication required per week;Change from baseline in weekly Opioid-Related Symptom Distress Scale;Adverse events;Standard safety assessments;Orthostatic (supine/standing) blood pressure assessment;Weight and Height measurements, Physical examinations.;Neurologic examination (Neuropathy Impairment Score [NIS]).;Survey of Autonomic Symptom scores;Anti-drug antibody (ADA) assessments;Joint safety adjudication outcomes;Total joint replacements",2013-002223-42;CANCER PAIN PH 3 SC STUDY;A4091061,Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy.,"A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2015-10-26,2015-10-28,156,"Active, not recruiting",Pfizer,Eli Lilly and Company,"argentina;australia;austria;brazil;chile;china;czechia;hungary;israel;japan;korea, republic of;poland;romania;slovakia;spain;united kingdom;argentina;australia;austria;brazil;chile;china;czechia;hungary;israel;japan;korea, republic of;poland;romania;slovakia;spain;united kingdom;czech republic;france;germany",Drug: Tanezumab,"
Inclusion Criteria:
- Personally signed and dated informed consent document.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.
- Male or female, =18 years of age
- Weight =40 kg at Screening
- Cancer diagnosed as having metastasized to bone or multiple myeloma.
- Imaging confirmation of bone metastasis at Screening or within 120 days prior to the
Screening visit.
- Expected to require daily opioid medication throughout the course of the study.
- Willing to not use prohibited medications (including NSAIDs) throughout the duration
of the study.
- Average Pain Score =5 at Screening for the index bone metastasis cancer pain site.
- Patient's Global Assessment of Cancer Pain of fair, poor or very poor at
Screening.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 at
Screening.
- Adequate bone marrow, renal and liver function at Screening.
- International Normalized Ratio (INR) or prothrombin time (PT) <1.5 x ULN at Screening
unless being treated with anticoagulant medication.
- Females must either be not of childbearing potential or, if of childbearing potential
and at risk for pregnancy, must be willing to use at least one highly effective method
of contraception throughout the study and for 112 days (16 weeks) after the last dose
of assigned subcutaneous study medication.
Exclusion Criteria:
- Pain related to an oncologic emergency.
- Brain metastasis or leptomeningeal metastasis.
- Presence of hypercalcemia at Screening.
- Pain primarily classified as not predominantly related to a bone metastasis.
- Systemic treatment for the primary malignancy or bone metastasis started within 30
days of the Baseline Assessment Period.
- Chemotherapies associated with peripheral neuropathy (ie, paclitaxel, docetaxel,
oxaliplatin, cisplatin, vincristine, thalidomide or bortezomib) are prohibited during
the study from 30 days prior to the first day of the Baseline Assessment Period to
Week 48.
- Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone
metastasis within 30 days of the Baseline Assessment Period.
- Concurrent adjuvant analgesics unless started at least 30 days prior to the start of
the Baseline Assessment Period and maintained at a stable dose.
- Diagnosis of osteoarthritis of the knee or hip or findings consistent with
osteoarthritis in the shoulder.
- History of significant trauma or surgery to a major joint within one year prior to
Screening.
- History of osteonecrosis or osteoporotic fracture.
- X-ray evidence at Screening of: 1) rapidly progressive osteoarthritis, 2) atrophic or
hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous
osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture.
- Signs and symptoms of clinically significant cardiac disease.
- Evidence of orthostatic hypotension at Screening or at Baseline prior to
randomization.
- Diagnosis of a transient ischemic attack in the 6 months prior to Screening or
diagnosis of stroke with significant residual deficits.
- History, diagnosis, or signs and symptoms of clinically significant neurological
disease.
- Total impact score of >7 on the Survey of Autonomic Symptoms (SAS) at Screening.
- Past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one
year prior to Screening.
- History of significant alcohol, analgesic, or narcotic substance abuse within the six
months prior to Screening.
- Planned surgical procedure during the duration of the study.
- Considered unfit for surgery or not willing to undergo joint replacement surgery if
required.
- Known hypersensitivity to opioids or an underlying medical condition contraindicating
opioid use.
- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
antibody or IgG-fusion protein.
- Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor
antibody.
- Presence of drugs of abuse, prescription medications without a valid prescription or
other illegal drugs at Screening.
- Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests at
Screening indicative of current infection.
- Investigational site staff members and their family members, or Pfizer employees
directly involved in the conduct of the trial.
- Participation in other studies involving investigational drug(s) within 30 days (or 90
days for investigational biologics) before Baseline Assessment Period and/or during
study participation.
- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential who are unwilling or unable to use one (1) highly effective
method of contraception throughout the study and for 112 days after last dose of
investigational product.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality.
",NULL,Change from baseline in daily average pain intensity in index bone metastasis cancer pain site,"Change from baseline in daily average pain intensity in index bone metastasis cancer pain site;Change from baseline in daily worst pain intensity in index bone metastasis cancer pain site;Change from baseline in weekly average pain intensity in non-index cancer pain sites;Change from baseline in weekly worst pain intensity in non-index cancer pain sites;Change from baseline in daily average pain intensity in non-index visceral cancer pain sites;Change from baseline in daily worst pain intensity in non-index visceral cancer pain sites;Change from baseline in Brief Pain Inventory (BPI) average pain score;Change from baseline in BPI worst pain score;Response as defined by a 30%, 50%, 70%, and 90% reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site;Change from baseline in Patient's Global Assessment of Cancer Pain;Response defined as an improvement of 2 points in Patient's Global Assessment of Cancer Pain;Change from baseline in the BPI Pain Interference with Function composite score and individual pain interference item scores;EuroQol 5 Dimension (EQ-5D-5L) dimensions and overall health utility score;Average daily total opioid consumption (in mg of morphine equivalent doses);Average number of doses of rescue medication required per week;Change from baseline in weekly Opioid-Related Symptom Distress Scale;Adverse events;Standard safety assessments;Orthostatic (supine/standing) blood pressure assessment;Weight and Height measurements, Physical examinations.;Neurologic examination (Neuropathy Impairment Score [NIS]).;Survey of Autonomic Symptom scores;Anti-drug antibody (ADA) assessments;Joint safety adjudication outcomes;Total joint replacements",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-10-28,2015-10-26,2015-10-26,156,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2020-11-20,TRUE,FALSE,TRUE
4579,NCT02597439,NA,NCT02597439,NCT: 2015-10-15 ICTRP: 2015-10-15 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,3,NA,"no AM, no metric",NCT: Anticipated 220 ICTRP: 220 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome in title,kein Artikel,NA,NA,2015-11-05,NA,2016-09-30,2023-01-31,Interventional,Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe,Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe,Recruiting,N/A,220,Anticipated,UMC Utrecht,Transition rate,Blood levels of (epi)genetic markers;Blood levels of immune parameters;Discontinuation rate;Symptomatology;Psychosocial functioning;Cognitive function;MRI measures;Blood levels of bioactive lipids;Tolerability associated with omega-3 fatty acid treatment;Positive and negative symptoms;Level of functioning;Clinical Impression;Level of depression;Role functioning;Social functioning,2015-003503-39;ABR54654,Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe,Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe,;I.E.Slot-3@umcutrecht.nl,;I.E.Slot-3@umcutrecht.nl,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). ",N/A,2015-10-15,2016-09-30,220,Recruiting,Rene Kahn,NULL,austria;germany;israel;italy;netherlands;norway;spain;switzerland;united kingdom;austria;germany;israel;italy;netherlands;norway;spain;switzerland;united kingdom,Drug: Omega-3 fatty acids;Other: Placebo,"
Inclusion Criteria:
- Written informed consent of the subject. For individuals younger than 18 years of age
the parents / legal representatives need to give consent, and the subject can provide
assent (whether the latter is required depends on local laws and regulations).
- UHR diagnosis as made using the Comprehensive Assessment of At-Risk Mental States
(CAARMS) (Yung et al., 2005). Subjects have to meet one or more of the following
criteria: (a) attenuated psychotic symptoms, (b) brief limited intermittent psychotic
symptoms (a history of one or more episodes of frank psychotic symptoms that resolved
spontaneously within 1 week in the past year), or (c) either the presence of
schizotypal personality disorder or a family history of psychosis in a first-degree
relative, all three together with a recent decline in function.
Exclusion Criteria:
- Any clinically significant medical condition that may influence the results of the
trial or affect the ability to take part in a trial.
- Laboratory screening values considered clinically relevant by a medical doctor for
transaminases, thyroid hormones or coagulation parameters
- Current or past DSM-IV diagnosis of psychosis, as measured with K-SADS-PL
- Current treatment with an antipsychotic or mood-stabilising agent
- Intake of an antipsychotic or mood-stabilising agent in the two weeks prior to study
inclusion
- Intake of an antipsychotic agent equivalent to a total haloperidol use of >50 mg in
the six months prior to study inclusion
- A first-degree relative (i.e. parents, offspring or siblings) participating in this
study
- UHR diagnosis on the basis of attenuated psychotic symptoms that are entirely
explained by acute intoxication
- Current aggression or dangerous behaviour (PANSS G14 score 5 or above)
- Current suicidality / self-harm (PANSS G6 score 7)
- Current DSM-IV diagnosis of alcohol or substance dependence as measured with K-SADS-PL
- Any current or previous neurological disorder, including epilepsy
- History of head injury resulting in unconsciousness lasting at least 1 hour
- IQ < 70
- More than 4 weeks of regular omega-3 supplementation (>2 daily capsules standard
strength providing >600 mg combined EPA/DHA) within the last 6 months.
",NULL,Transition rate,Discontinuation rate;Symptomatology;Psychosocial functioning;Cognitive function;MRI measures;Blood levels of bioactive lipids;Tolerability associated with omega-3 fatty acid treatment;Blood levels of (epi)genetic markers;Blood levels of immune parameters;Positive and negative symptoms;Level of functioning;Clinical Impression;Level of depression;Role functioning;Social functioning,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-09-30,2015-10-15,2015-10-15,220,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-11-30,TRUE,FALSE,TRUE
4698,NCT02570165,NA,NCT02570165,NCT: 2015-10-05 ICTRP: 2015-10-05 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 325 ICTRP: 325 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Abstract,https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2017.195.1_MeetingAbstracts.A3607,NA,2015-10-07,NA,2015-11-06,2016-07-06,Interventional,Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD),Study 201012: A Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With COPD,Completed,Phase 2,325,Actual,GlaxoSmithKline,Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42,Change From Baseline in Trough FEV1 at Day 42,2015-001409-15;201012,Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD),Study 201012: A Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With COPD,,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2015-10-05,2015-11-06,325,Completed,GlaxoSmithKline,NULL,united states;germany;south africa;germany;south africa;united states,Drug: Batefenterol;Drug: Umeclidinium/ Vilanterol;Drug: Placebo,"
Inclusion Criteria:
- Type of subject: Outpatient
- Informed Consent: A signed and dated written informed consent prior to study
participation
- Age: 40 years of age or older at Visit 1.
- Gender: Male and female subjects are eligible to participate in the study. Female
subjects are eligible to participate if not pregnant (as confirmed by a negative urine
human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the
following conditions applies:
Non-reproductive potential defined as:
Pre-menopausal females with one of the following: Documented tubal ligation Documented
hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal
occlusion Hysterectomy Documented Bilateral Oophorectomy Postmenopausal defined as 12
months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose
menopausal status is in doubt will be required to use one of the highly effective
contraception methods if they wish to continue their HRT during the study. Otherwise, they
must discontinue HRT to allow confirmation of postmenopausal status prior to study
enrolment.
Reproductive potential and agrees to follow one of the options listed below 30 days prior
to the first dose of study medication and until at least five terminal half-lives OR until
any continuing pharmacologic effect has ended, whichever is longer after the last dose of
study medication and completion of the follow-up visit. This list does not apply to females
of reproductive potential with same sex partners, when this is their preferred and usual
lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal
intercourse on a long term and persistent basis.
Contraceptive subdermal implant that meets <1 percent (%) rate of failure per year, as
stated in the product label Intrauterine device or intrauterine system that meets <1% rate
of failure per year, as stated in the product label Oral Contraceptive, either combined or
progestogen alone Injectable progestogen Contraceptive vaginal ring Percutaneous
contraceptive patches Male partner sterilization with documentation of azoospermia prior to
the female subjects entry into the study, and this male is the sole partner for that
subject These allowed methods of contraception are only effective when used consistently,
correctly and in accordance with the product label. The investigator is responsible for
ensuring that subjects understand how to properly use these methods of contraception.
- Diagnosis: An established clinical history of COPD in accordance with the definition
by the American Thoracic Society/European Respiratory Society as follows: Chronic
obstructive pulmonary disease is a preventable and treatable disease state
characterized by airflow limitation that is not fully reversible. The airflow
limitation is usually progressive and is associated with an abnormal inflammatory
response of the lungs to noxious particles or gases, primarily caused by cigarette
smoking.
- Smoking History: Current or former cigarette smokers with a history of cigarette
smoking of >=10 pack-years. Former smokers are defined as those who have stopped
smoking for at least 6 months prior to Visit 1. Number of pack years = (number of
cigarettes per day / 20) x number of years smoked (e.g. 20 cigarettes per day for 10
years, or 10 cigarettes per day for 20 years both equal 10 pack-years). Note: pipe and
cigar cannot be used to calculate pack-year history.
- Severity of Disease: A post-albuterol/salbutamol FEV1/FVC ratio of <=0.70 and a
post-albuterol/salbutamol FEV1 >=30 and <=70% of predicted normal at Visit 1.
Note: Percent predicted will be calculated using the European Respiratory Society Global
Lung Function Initiative reference equations.
Exclusion Criteria:
- Asthma: Subjects with a current diagnosis of asthma. (subjects with a prior history of
asthma are eligible if they have a current diagnosis of COPD).
- Other Respiratory Disorders: Known respiratory disorders other than COPD including but
not limited to alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis,
sarcoidosis, lung fibrosis, pulmonary hypertension unrelated to COPD, and interstitial
lung disease. Allergic rhinitis is not exclusionary.
- Other Diseases/Abnormalities: Any significant diseases (including uncontrolled
hypertension, diabetes and thyroid disease) that in the opinion of the investigator or
the study medical monitor would put the safety of the subject at risk through study
participation, or which would affect study analyses if the diseases/condition
exacerbated during the study.
- Hepatitis: Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C
antibody test result at screening Visit 1 or within 3 months prior to first dose of
study treatment. (subjects with positive hepatitis C antibody due to prior resolved
disease can be enrolled only if a confirmatory negative Hepatitis C ribonucleic acid
(RNA) polymerase chain reaction (PCR) test is obtained).
- Liver Disease: Current or chronic history of liver disease, known hepatic or biliary
abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Cancer: A current malignancy or previous history of cancer in remission for <5 years
prior to Visit 1 (localised basal cell or squamous cell carcinoma of the skin that has
been resected is not exclusionary.) Any current or previous history of throat cancer.
- Chest X-Ray: A chest X-ray or computed tomography (CT) scan that reveals evidence of
clinically significant abnormalities not believed to be due to the presence of COPD. A
chest X-ray must be taken at Visit 1 if a chest X-ray or CT scan is not available
within 6 months prior to Visit 1. For subjects in Germany, if a chest X-ray (or CT
scan) is not available in the 6 months prior to Visit 1 the subject will not be
eligible for the study.
- Drug Allergy: A history of hypersensitivity or allergy to any beta adrenergic
receptor-agonist, sympathomimetic, anticholinergic/anti-muscarinic receptor
antagonist, or lactose/milk protein, which in the opinion of the investigator or
GlaxoSmithKline (GSK) medical monitor contraindicates study participation.
- Diseases Preventing Use of Anticholinergic: Medical diagnosis of narrow- angle
glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the
study investigator would prevent use of an inhaled anticholinergic.
- Poorly controlled COPD: defined as the occurrence of 'acute worsening of COPD that is
managed with corticosteroid and/or antibiotics or t",NULL,Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42,Change From Baseline in Trough FEV1 at Day 42,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-11-06,2015-10-05,2015-10-05,325,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2019-07-05,TRUE,FALSE,TRUE
4718,NCT02564718,NA,NCT02564718,NCT: 2015-09-04 ICTRP: 2015-09-04 DRKS: NA,1,1,NA,1,1,NA,Diagnosis of thrombosis unclear,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 10 ICTRP: 10 DRKS: NA,10,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/s2352-3026(19)30161-9,2019-08-13,2015-10-01,NA,2015-11-19,2017-12-18,Interventional,Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates,"7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis",Completed,Phase 1/Phase 2,10,Actual,Bayer,Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1;Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3;Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8;Change From Baseline in Prothrombin Time at Day 1;Change From Baseline in Prothrombin Time at Day 3;Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1;Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3;Anti-factor Xa Activity (Anti-Xa) Values at Day 1;Anti-factor Xa Activity (Anti-Xa) Values at Day 3;Anti-factor Xa Activity (Anti-Xa) Values at Day 8,Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events;Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging,2014-002385-74;17618,Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates,"7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis",,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). ,Phase 1/Phase 2,2015-09-04,2015-11-19,10,Completed,Bayer,"Janssen Research & Development, LLC","austria;france;germany;israel;italy;spain;turkey;austria;france;germany;israel;italy;spain;turkey;australia;canada;finland;korea, republic of;netherlands;poland;switzerland;united states","Drug: Rivaroxaban (Xarelto, BAY59-7939)","
Inclusion Criteria:
- Children from birth to less than 6 months with documented symptomatic or asymptomatic
venous or arterial thrombosis who have been treated with anticoagulant therapy for at
least 5 days.
- Gestational age at birth of at least 37 weeks.
- Hemoglobin, platelets, creatinine, ALT and total and direct bilirubin assessed within
10 days prior to enrollment.
- Oral feeding/nasogastric/gastric feeding for at least 10 days.
- Informed consent provided.
- Body weight >2600 g
Exclusion Criteria:
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy,
including history of intra-ventricular bleeding.
- Symptomatic progression of thrombosis during preceding anticoagulant treatment.
- Planned invasive procedures, including lumbar puncture and removal of non-peripherally
placed central lines during study treatment.
- Hepatic disease which is associated with either: coagulopathy leading to a clinically
relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal
(ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total.
- Creatinine >1.5 times of normal.
- Uncontrolled Hypertension defined as >95th percentile.
- History of gastrointestinal disease or surgery associated with impaired absorption.
- Platelet count <100 x 109/L.
- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4)
and P-glycoprotein (P-gp), e.g. all human immunodeficiency virus protease inhibitors
and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole,
posaconazole, if used systemically (fluconazole is allowed)
- Concomitant use of strong inducers of CYP3A4, e.g. rifampicin, rifabutin,
phenobarbital, phenytoin and carbamazepine
- Indication for anticoagulant therapy other than current thrombosis.
- Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID)
therapy. Incidental use is allowed.
- Hypersensitivity to rivaroxaban or its excipients.
- Participation in a study with an investigational drug or medical device within 30 days
prior to enrollment.
",NULL,Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1;Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3;Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8;Change From Baseline in Prothrombin Time at Day 1;Change From Baseline in Prothrombin Time at Day 3;Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1;Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3;Anti-factor Xa Activity (Anti-Xa) Values at Day 1;Anti-factor Xa Activity (Anti-Xa) Values at Day 3;Anti-factor Xa Activity (Anti-Xa) Values at Day 8,Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events;Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-11-19,2015-09-04,2015-09-04,10,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2018-06-12,TRUE,FALSE,TRUE
18749,NCT00058838,NA,NCT00058838,NCT: 2003-04-14 ICTRP: 2003-04-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,0,NA,"information on ""Arms and Interventions"" is empty",3,NA,"no AM, no time frame",1,NA,"no AM, no time frame, no metric, no measure",NCT: NA 854 ICTRP: 854 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2003-04-15,NA,2003-04-30,2004-09-30,Interventional,Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease,"A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.",Completed,Phase 3,854,NA,Pfizer,"Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo",To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo,DA2APD-0075-031,Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease,"A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 3,2003-04-14,2003-04-20,854,Completed,Pfizer,NULL,united states;argentina;australia;austria;belgium;colombia;france;germany;greece;italy;mexico;peru;puerto rico;spain;united states;argentina;australia;austria;belgium;colombia;france;germany;greece;italy;mexico;peru;puerto rico;spain,Drug: sumanirole,"
Inclusion Criteria:
Idiopathic Parkinson's disease < 7 years duration
Modified Hoehn and Yahr Scale Stages I through III
Age greater than or equal to 30 years old
Patients or their partners must use adequate contraceptive methods
Patients who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures and do not plan on traveling extensively
during the study
Exclusion Criteria:
Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or
degenerative diseases.
Levodopa received for 1-year accumulated interval in the last two years.
Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days
prior to baseline.
Unstable dose regimes of hypnotics, anxiolytics or antidepressants
Dementia
History of stereotaxic brain surgery, psychosis or active epilepsy within past year.
Participation in clinical trial within the previous 30 days.
Malignant melanoma or history of melanoma
Significant medical or pshychiatric condition
",NULL,"Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo",To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-04-30,2003-04-14,2003-04-14,854,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2003,2006-06-06,TRUE,FALSE,FALSE
16515,NCT00415844,NA,NCT00415844,NCT: 2006-12-22 ICTRP: 2006-12-22 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,1,NA,"no AM, no metric, no time frame, no measure",1,NA,"""Satety and tolerability""",NCT: NA 42 ICTRP: 42 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-12-25,NA,2006-06-30,NA,Interventional,Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers,"A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 25 mg Carbidopa, 100 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 25 mg Carbidopa and 100 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fasting Conditions",Completed,Phase 1,42,NA,Novartis,Bioequivalence between 25 mg carbidopa/100 mg levodopa/200 mg entacapone single dose combination and 25 mg carbidopa/100 mg levodopa single dose combination plus 200 mg entacapone single doses when administered under fasting conditions,Safety and tolerability,CELC200A2103,Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers,"A Randomized, Two-Way Crossover Study to Investigate the Bioavailability of a Single Oral Dose of 25 mg Carbidopa, 100 mg Levodopa and 200 mg Entacapone Compared to a Single Oral Combined Dose of Both 25 mg Carbidopa and 100 mg Levodopa and 200 mg Entacapone in Healthy Volunteers Under Fasting Conditions",,,Interventional,"Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 1,2006-12-22,2006-06-20,42,Completed,Novartis,NULL,germany,Drug: ELC200 (carbidopa+levodopa+entacapone),"
Inclusion Criteria:
- Healthy male and female subjects age 18 to 55 years of age included, and in good
health
- At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and
pulse rate) will be assessed after the subject has rested for at least five (5)
minutes, and again when required after three (3) minutes in the standing position.
Vital signs should be within the normal ranges
- Body mass index (BMI) within the range of 18 to 27 and weigh at least 50 kg
- Female subjects must have undergone hysterectomy, or must be postmenopausal.
Exclusion Criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or
psychiatric disease
- History of malignancy of any organ system, treated or untreated, within the past 5
years whether or not there is evidence of local recurrence or metastases, with the
exception of localized basal cell carcinoma of the skin
- Receiving monoamine oxidase (MAO) inhibitors within 28 days prior to the first dose
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- History of clinically significant drug allergy or history of atopic allergy (asthma,
urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or
drugs similar to the study drug.
- Significant illness within two weeks prior to dosing
- Subjects who, through completion of the study, would have donated in excess of: 500
mL of blood in 14 days; 1500 mL of blood in 180 days; 2500 mL of blood in 1 year.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western
blot) test result.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of
such abuse as indicated by the laboratory assays conducted during the screening or
baseline evaluations.
- Women of child bearing potential ( WOCBP)
- History or presence of glaucoma or any suspicious undiagnosed skin lesions
Other protocol-defined inclusion/exclusion criteria may apply
",NULL,Bioequivalence between 25 mg carbidopa/100 mg levodopa/200 mg entacapone single dose combination and 25 mg carbidopa/100 mg levodopa single dose combination plus 200 mg entacapone single doses when administered under fasting conditions,Safety and tolerability,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-06-30,2006-12-22,2006-12-22,42,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2006,2007-06-21,TRUE,FALSE,FALSE
20816,NCT03574597,NA,CTRI/2018/10/016193,NCT: NA ICTRP: 2018-10-29 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure (for infarction)",4,NA,no AM,NCT: NA ICTRP: 17500 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-07-02,NA,2018-10-24,2023-09-28,Interventional,Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity,SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity,Recruiting,Phase 3,17500,Anticipated,Novo Nordisk A/S,"Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke","Change in high density lipoprotein (HDL) cholesterol;Change in low density lipoprotein (LDL) cholesterol;Change in triglycerides;Change in body weight;Change in systolic blood pressure;Change in diastolic blood pressure;Change in pulse;Change in waist circumference;Change in High sensitivity C-Reactive Protein (hsCRP);Change in total cholesterol;Time to CV death;Time to all-cause death;Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation;Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death;Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke;Time to first occurrence of non-fatal myocardial infarction;Time to first occurrence of non-fatal stroke;Time to first occurrence of coronary revascularisation;Time to first occurrence of unstable angina requiring hospitalisation;Time to first occurrence of heart failure hospitalisation or urgent heart failure visit;Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%);Time to first occurrence of a 5-component composite nephropathy endpoint;Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%);Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%);Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire;Change in total score weight related sign and symptom measure;Change in haemoglobin A1c (HbA1c);Change in HbA1c",2017-003380-35;U1111-1200-5564;EX9536-4388,Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity,SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity,;clinicaltrials@novonordisk.com,;clinicaltrials@novonordisk.com,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2018-06-21,2018-10-24,17500,Recruiting,Novo Nordisk A/S,NULL,united states;algeria;argentina;australia;austria;belgium;brazil;bulgaria;canada;colombia;croatia;czechia;denmark;finland;france;germany;greece;hungary;india;ireland;israel;italy;japan;latvia;malaysia;mexico;netherlands;norway;poland;portugal;puerto rico;romania;russian federation;serbia;south africa;spain;sweden;taiwan;thailand;turkey;ukraine;united kingdom;algeria;argentina;australia;austria;belgium;brazil;bulgaria;canada;colombia;croatia;czechia;denmark;finland;france;germany;greece;hungary;india;ireland;israel;italy;japan;latvia;malaysia;mexico;netherlands;norway;poland;portugal;puerto rico;romania;russian federation;serbia;south africa;spain;sweden;taiwan;thailand;turkey;ukraine;united kingdom;united states,Drug: Semaglutide;Drug: Placebo (semaglutide),"
Inclusion Criteria:
- Male or female, age greater than or equal to 45 years at the time of signing informed
consent
- Body mass index (BMI) greater than or equal to 27 kg/m^2
- Have established cardiovascular (CV) disease as evidenced by at least one of the
following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic
stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by
intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or
peripheral arterial revascularization procedure, or amputation due to atherosclerotic
disease
Exclusion Criteria:
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable
angina pectoris or transient ischaemic attack within the past 60 days prior to the day
of screening
- HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central
laboratory at screening
- History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
",NULL,"Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke","Time to CV death;Time to all-cause death;Time to first occurrence of an expanded composite CV endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation or unstable angina requiring hospitalisation;Time to first occurrence of a composite heart failure endpoint consisting of: heart failure hospitalisation, urgent heartfailure visit or CV death;Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction, or non-fatal stroke;Time to first occurrence of non-fatal myocardial infarction;Time to first occurrence of non-fatal stroke;Time to first occurrence of coronary revascularisation;Time to first occurrence of unstable angina requiring hospitalisation;Time to first occurrence of heart failure hospitalisation or urgent heart failure visit;Time to first occurrence of HbA1c greater than or equal to 48 mmol/mol (6.5%);Time to first occurrence of a 5-component composite nephropathy endpoint;Time to HbA1c greater than or equal to 39 mmol/mol (5.7%) for subjects with a screening HbA1c less than 39 mmol/mol (5.7%);Subjects with HbA1c less than 39 mmol/mol (5.7%) at each visit where HbA1c is assessed for subjects with a screening HbA1c greater than or equal to 39 mmol/mol (5.7%);Change in systolic blood pressure;Change in diastolic blood pressure;Change in pulse;Change in High sensitivity C-Reactive Protein (hsCRP);Change in total cholesterol;Change in high density lipoprotein (HDL) cholesterol;Change in low density lipoprotein (LDL) cholesterol;Change in triglycerides;Change in body weight;Change in waist circumference;Change in EuroQol five dimensions five level (EQ-5D-5L) questionnaire;Change in total score weight related sign and symptom measure;Change in haemoglobin A1c (HbA1c);Change in HbA1c",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-10-24,2018-06-21,2018-06-21,17500,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-12-16,TRUE,FALSE,FALSE
31498,NCT00827983,NA,EUCTR2007-006595-11,NCT: NA ICTRP: 2008-06-23 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,NA,NA,NA,NCT: NA ICTRP: 672 DRKS: NA,683,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,http://dx.doi.org/10.1016/j.fertnstert.2013.09.010,2013-10-18,2009-01-23,NA,2009-01-31,2011-05-31,Interventional,Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF),Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF),Completed,Phase 3,683,Actual,IBSA Institut Biochimique SA,Ongoing Pregnancy Rate at the End of the Study,Delivery Rate and Live Birth Rate;Implantation Rate,07EU/Prg06,Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF),Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF),NULL,NULL,Interventional,,Phase 3,2009-01-22,2009-01-20,683,Completed,IBSA Institut Biochimique SA,NULL,germany;hungary;italy;switzerland;united kingdom;germany;hungary;italy;switzerland;united kingdom;germany;hungary;italy;switzerland;united kingdom;germany;hungary;italy;switzerland;united kingdom;germany;hungary;italy;switzerland;united kingdom;germany;hungary;italy;switzerland;united kingdom;germany;hungary;italy;switzerland;united kingdom;germany;hungary;italy;switzerland;united kingdom,Drug: Progesterone;Drug: Progesterone;Drug: Progesterone;Drug: Progesterone;Drug: Progesterone;Drug: Progesterone;Drug: Progesterone;Drug: Progesterone,"
Inclusion Criteria:
- Age 18- 42 (upon starting COH);
- BMI <30 kg/m2;
- <3 prior ART cycles (IVF, ICSI and related procedures);
- Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
- Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or
hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
- At least 3 retrieved oocytes;
- Patient has given written informed consent.
Exclusion Criteria:
- Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- History of past poor response to COH resulting in canceling ART;
- Use of thawed/donated oocytes;
- Use of thawed/donated embryos;
- Patients affected by pathologies associated with any contraindication of being
pregnant;
- Hypersensitivity to study medication;
- Uncontrolled adrenal or thyroid dysfunction;
- Undiagnosed vaginal bleeding;
- History of arterial disease;
- Patients with hepatic impairment;
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- Active thrombophlebitis or thromboembolic disorders, or a history of
hormone-associated thrombophlebitis or thromboembolic disorders;
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
wherein pregnancy developed to a minimum of a gestational sac on TVUS;
- Participation in a concurrent clinical trial or another trial within the past 2
months;
- Use of concomitant medications that might interfere with the study evaluation;
- Pre-implantation genetic diagnosis/screening.
;
Inclusion Criteria:
- Age 18- 42 (upon starting COH);
- BMI <30 kg/m2;
- <3 prior ART cycles (IVF, ICSI and related procedures);
- Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
- Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or
hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
- At least 3 retrieved oocytes;
- Patient has given written informed consent.
Exclusion Criteria:
- Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- History of past poor response to COH resulting in canceling ART;
- Use of thawed/donated oocytes;
- Use of thawed/donated embryos;
- Patients affected by pathologies associated with any contraindication of being
pregnant;
- Hypersensitivity to study medication;
- Uncontrolled adrenal or thyroid dysfunction;
- Undiagnosed vaginal bleeding;
- History of arterial disease;
- Patients with hepatic impairment;
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- Active thrombophlebitis or thromboembolic disorders, or a history of
hormone-associated thrombophlebitis or thromboembolic disorders;
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
wherein pregnancy developed to a minimum of a gestational sac on TVUS;
- Participation in a concurrent clinical trial or another trial within the past 2
months;
- Use of concomitant medications that might interfere with the study evaluation;
- Pre-implantation genetic diagnosis/screening.
;
Inclusion Criteria:
- Age 18- 42 (upon starting COH);
- BMI <30 kg/m2;
- <3 prior ART cycles (IVF, ICSI and related procedures);
- Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
- Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or
hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
- At least 3 retrieved oocytes;
- Patient has given written informed consent.
Exclusion Criteria:
- Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- History of past poor response to COH resulting in canceling ART;
- Use of thawed/donated oocytes;
- Use of thawed/donated embryos;
- Patients affected by pathologies associated with any contraindication of being
pregnant;
- Hypersensitivity to study medication;
- Uncontrolled adrenal or thyroid dysfunction;
- Undiagnosed vaginal bleeding;
- History of arterial disease;
- Patients with hepatic impairment;
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- Active thrombophlebitis or thromboembolic disorders, or a history of
hormone-associated thrombophlebitis or thromboembolic disorders;
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
wherein pregnancy developed to a minimum of a gestational sac on TVUS;
- Participation in a concurrent clinical trial or another trial within the past 2
months;
- Use of concomitant medications that might interfere with the study evaluation;
- Pre-implantation genetic diagnosis/screening.
;
Inclusion Criteria:
- Age 18- 42 (upon starting COH);
- BMI <30 kg/m2;
- <3 prior ART cycles (IVF, ICSI and related procedures);
- Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
- Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or
hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
- At least 3 retrieved oocytes;
- Patient has given written informed consent.
Exclusion Criteria:
- Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- History of past poor response to COH resulting in canceling ART;
- Use of thawed/donated oocytes;
- Use of thawed/donated embryos;
- Patients affected by pathologies associated with any contraindication of being
pregnant;
- Hypersensitivity to study medication;
- Uncontrolled adrenal or thyroid dysfunction;
- Undiagnosed vaginal bleeding;
- History of arterial disease;
- Patients with hepatic impairment;
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- Active thrombophlebitis or thromboembolic disorders, or a history of
hormone-associated thrombophlebitis or thromboembolic disorders;
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
wherein pregnancy developed to a minimum of a gestational sac on TVUS;
- Participation in a concurrent clinical trial or another trial within the past 2
months;
- Use of concomitant medications that might interfere with the study evaluation;
- Pre-implantation genetic diagnosis/screening.
",NULL,Ongoing Pregnancy Rate at the End of the Study;Ongoing Pregnancy Rate at the End of the Study,Delivery Rate and Live Birth Rate;Implantation Rate,NCT00827983; 07EU/Prg06,2012-11-22,no,In Vitro Fertilization; fertilization,Arm 1 Drug: Progesterone; Arm 2 Drug: Progesterone,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,III,- Ongoing Pregnancy Rate at the End of the Study; time frame: 10 weeks after treatment start
,- Delivery Rate and Live Birth Rate; time frame: nearly 9 month after treatment start
- Implantation Rate; time frame: Four to five weeks after oocytes retrieval; Implantation rate was defined as the mean of the total number of gestational sacs seen divided by the total number of embryos transferred. Values are reported as a percentage.
,Germany; Hungary; Italy; Switzerland; United Kingdom,[---]* Lübeck,2009-01-31,NA,683,2011-05-01,"- Age 18- 42 (upon starting COH);
- BMI <30 kg/m2;
- <3 prior ART cycles (IVF, ICSI and related procedures);
- Baseline (day 2-3 of cycling) FSH <15 IU/L and E2 <80 pg/mL;
- Normal uterine cavity as per recent hysterosalpingogram, sonohysterogram or
hysteroscopic exam (i.e. no polyp or protruding sub-mucosal fibroid);
- At least 3 retrieved oocytes;
- Patient has given written informed consent.
","- Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
- Stage III or IV endometriosis (endometriomas);
- Hydrosalpinx;
- History of past poor response to COH resulting in canceling ART;
- Use of thawed/donated oocytes;
- Use of thawed/donated embryos;
- Patients affected by pathologies associated with any contraindication of being
pregnant;
- Hypersensitivity to study medication;
- Uncontrolled adrenal or thyroid dysfunction;
- Undiagnosed vaginal bleeding;
- History of arterial disease;
- Patients with hepatic impairment;
- Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
- High grade cervical dysplasia;
- Active thrombophlebitis or thromboembolic disorders, or a history of
hormone-associated thrombophlebitis or thromboembolic disorders;
- History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages
wherein pregnancy developed to a minimum of a gestational sac on TVUS;
- Participation in a concurrent clinical trial or another trial within the past 2
months;
- Use of concomitant medications that might interfere with the study evaluation;
- Pre-implantation genetic diagnosis/screening.
",Efficacy and Tolerability of Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Patients Undergoing In-Vitro Fertilization (IVF),"Recruiting complete, follow-up complete",IBSA Institut Biochimique SA,NA,Arm 1 Drug: Progesterone; Arm 2 Drug: Progesterone,2009-01-31,2009-01-22,2009-01-22,683,Interventional,FALSE,FALSE,TRUE,FALSE,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,2009,2013-01-28,TRUE,TRUE,TRUE
15470,NCT00571948,NA,NCT00571948,NCT: 2007-12-11 ICTRP: 2007-12-11 DRKS: NA,1,1,NA,2,1,NA,NA,2,0,Meat percentage in intervention 2 not 13% (as registered) but 12%,5,1,NA,4,0,no AM; dietary intake not reported,NCT: Actual 132 ICTRP: 132 DRKS: NA,76,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Double,worse,0,No outcome and intervention in title,ganzer Artikel,https://doi.org/10.1016/j.clnu.2010.05.002,2010-05-13,2007-12-12,NA,2005-09-30,2008-03-31,Interventional,Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.,Dortmund Intervention Trial for Optimization of Infant Nutrition,Completed,N/A,132,Actual,"Research Institute of Child Nutrition, Dortmund",Sum of Omega-3 Fatty Acid Pattern in Plasma;Parameters of Iron Status in Blood,"Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences",2XIKers,Modification in Complementary Food Composition to Improve the Status of Iron and Fatty Acids in Infants.,Dortmund Intervention Trial for Optimization of Infant Nutrition,;;;,;;;,Interventional,,N/A,2007-12-11,2005-09-20,132,Completed,"Research Institute of Child Nutrition, Dortmund",NULL,germany;germany;germany;germany,Other: more meat and a vegetable oil rich in omega-3 fatty acids;Other: Babyfood with usual meat content and corn oil;Other: more meat and a vegetable oil rich in omega-3 fatty acids;Other: Babyfood with usual meat content and corn oil;Other: more meat and a vegetable oil rich in omega-3 fatty acids;Other: Babyfood with usual meat content and corn oil;Other: more meat and a vegetable oil rich in omega-3 fatty acids;Other: Babyfood with usual meat content and corn oil,"
Inclusion Criteria:
- a term healthy newborn infant (birth weight > 2500 g, gestational age > 37 weeks);
- inclusion during the first two months of life.
- German speaking mother;
- the intention of the mother to breast-feed the child and to feed study menus 5 to 7
times per week beginning in the fifth to seventh month of life.
Exclusion Criteria:
- preterm infants
;
Inclusion Criteria:
- a term healthy newborn infant (birth weight > 2500 g, gestational age > 37 weeks);
- inclusion during the first two months of life.
- German speaking mother;
- the intention of the mother to breast-feed the child and to feed study menus 5 to 7
times per week beginning in the fifth to seventh month of life.
Exclusion Criteria:
- preterm infants
;
Inclusion Criteria:
- a term healthy newborn infant (birth weight > 2500 g, gestational age > 37 weeks);
- inclusion during the first two months of life.
- German speaking mother;
- the intention of the mother to breast-feed the child and to feed study menus 5 to 7
times per week beginning in the fifth to seventh month of life.
Exclusion Criteria:
- preterm infants
;
Inclusion Criteria:
- a term healthy newborn infant (birth weight > 2500 g, gestational age > 37 weeks);
- inclusion during the first two months of life.
- German speaking mother;
- the intention of the mother to breast-feed the child and to feed study menus 5 to 7
times per week beginning in the fifth to seventh month of life.
Exclusion Criteria:
- preterm infants
",NULL,Sum of Omega-3 Fatty Acid Pattern in Plasma;Parameters of Iron Status in Blood;Sum of Omega-3 Fatty Acid Pattern in Plasma;Parameters of Iron Status in Blood,"Dietary Intake; Anthropometric Measures: Body Weight, Body Lengths, Head Circumferences",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-09-30,2007-12-11,2007-12-11,132,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2005,2015-05-04,TRUE,FALSE,FALSE
9994,NCT01487421,NA,NCT01487421,NCT: 2011-11-25 ICTRP: 2011-11-25 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,2,NA,"no AM, no time frame, no metric",2,NA,"no AM, no metric, no time frame",NCT: Actual 2134 ICTRP: 2134 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2011-12-07,NA,2003-07-31,2006-10-31,Observational,"An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime","The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed",Completed,NA,2134,Actual,Novo Nordisk A/S,HbA1c (glycosylated haemoglobin),Fasting blood glucose (FBG);2-hours postprandial blood glucose;Hypoglycemia;Weight development;Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs),ANA-1934,"An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime","The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed",,,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2011-11-25,2003-07-20,2134,Completed,Novo Nordisk A/S,NULL,germany,Drug: insulin aspart;Drug: insulin detemir,
Inclusion Criteria:
- Type 2 diabetes
- OAD monotherapy
- OAD combination therapy
- Therapy with OAD and basal insulin
- Conventional insulin therapy with premixed insulin
,NULL,HbA1c (glycosylated haemoglobin),Fasting blood glucose (FBG);2-hours postprandial blood glucose;Hypoglycemia;Weight development;Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-07-31,2011-11-25,2011-11-25,2134,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2014-06-23,TRUE,FALSE,FALSE
17452,NCT00268216,NA,NCT00268216,NCT: 2005-12-20 ICTRP: 2005-12-20 DRKS: NA,1,1,NA,2,1,a,"additional criterion in article: ""an increase of FEV1 with the use of 400 μg of albuterol of less than 10%""",1,1,intervention not filled out. Information on intervention from summary. No arms specified: Parallel assignment but no comparator treatment mentioned,5,1,"We regard ""All cause mortality at 3 years"" as specific enough here.",4,1,no time frame,NCT: Actual 6228 ICTRP: 6228 DRKS: NA,6112,1,1,2,1,NA,Double,Double,ok,1,NA,ganzer Artikel,10.1056/NEJMoa063070,2007-02-22,2005-12-22,NA,2000-09-30,2005-11-30,Interventional,Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD),"A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment",Completed,Phase 3,6228,Actual,GlaxoSmithKline,All cause mortality at 3 years,Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.,SCO30003,Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD),"A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment",;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double. ,Phase 3,2005-12-20,2000-09-20,6228,Completed,GlaxoSmithKline,NULL,united states;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;united states;united states;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;united states;united states;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;united states;united states;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;united states;united states;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;argentina;australia;austria;belgium;brazil;bulgaria;canada;chile;china;croatia;czech republic;denmark;estonia;finland;france;germany;greece;hong kong;hungary;iceland;italy;latvia;lithuania;malaysia;mexico;netherlands;new zealand;norway;pakistan;philippines;poland;puerto rico;romania;russian federation;singapore;slovakia;south africa;spain;sweden;taiwan;thailand;ukraine;united kingdom;united states,Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg;Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg;Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg;Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg,
Inclusion criteria:
- Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)
FEV1/FVC ratio <70%.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
Exclusion criteria:
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
;
Inclusion criteria:
- Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)
FEV1/FVC ratio <70%.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
Exclusion criteria:
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
;
Inclusion criteria:
- Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)
FEV1/FVC ratio <70%.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
Exclusion criteria:
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
;
Inclusion criteria:
- Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)
FEV1/FVC ratio <70%.
- Current or ex-smokers with a smoking history of at least 10 pack-years.
Exclusion criteria:
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
,NULL,All cause mortality at 3 years;All cause mortality at 3 years;All cause mortality at 3 years,Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-09-30,2005-12-20,2005-12-20,6228,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2000,2017-01-19,TRUE,FALSE,FALSE
11217,NCT01298219,NA,NA,NCT: 2011-01-20 ICTRP: NA DRKS: NA,1,NA,NA,1,NA,NA,E.g. how is OBD diagnosed?,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 447 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2011-02-17,NA,2010-12-31,2011-11-30,Interventional,Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL),"A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction",Completed,Phase 3,439,Actual,Mallinckrodt,Number of Participants Classified as Treatment Responders Within 12 Weeks,Number of SBMs Per Week at Week 8;Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation;Number of SBMs Per Week at Week 12;Number of SBMs Per Week Overall,OBD1033,Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL),"A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2011-01-20,2010-12-20,439,Completed,"Sucampo Pharma Americas, LLC","Sucampo Pharmaceuticals, Inc.",united states;belgium;czechia;germany;poland;sweden;united kingdom;belgium;czechia;germany;poland;sweden;united kingdom;united states;czech republic,Drug: Lubiprostone;Drug: Placebo,"
Inclusion Criteria:
A patient can be considered for eligibility to participate if he/she:
- Has been consistently treated for chronic, noncancer-related pain with any oral,
transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to
screening
- Is diagnosed with OBD
- Is capable of utilizing an electronic diary to report daily spontaneous bowel
movements (SBMs)
- Is willing to continue opioid therapy and discontinue the use of laxatives, stool
softeners, and other concomitant medications affecting gastrointestinal motility
throughout the study
Exclusion Criteria:
A patient cannot be considered for eligibility to participate if he/she:
- Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical
bowel obstructions, bowel disorders, and constipation not arising from opioid use, but
instead attributable to dietary, neurologic, congenital, or endocrine disorders,
scleroderma, and/or for the management of drug addiction
",NULL,Number of Participants Classified as Treatment Responders Within 12 Weeks,Number of SBMs Per Week at Week 8;Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation;Number of SBMs Per Week at Week 12;Number of SBMs Per Week Overall,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-12-31,2011-01-20,2011-01-20,439,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2010,2020-02-03,TRUE,FALSE,TRUE
17668,NCT00235300,NA,NCT00235300,NCT: 2005-10-06 ICTRP: 2005-10-06 DRKS: NA,1,1,NA,1,NA,a,"""based on prolonged cold ischemia times"" not mentioned in register",2,1,NA,3,1,"No AM, no time frame; In Paper additional (longer) follow-up times.",3,1,"no AM, no measure",NCT: Actual 240 ICTRP: 240 DRKS: NA,183,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1186/s13063-015-0891-y,2015-08-19,2005-10-10,NA,2000-05-31,2005-06-30,Interventional,"An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.","An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients",Completed,Phase 2,240,Actual,Sanofi,"Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.",12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.,SMC-101-1010,"An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.","An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention",Phase 2,2005-10-06,2000-05-20,240,Completed,"Genzyme, a Sanofi Company",NULL,united states;france;germany;spain;united kingdom;united states;france;germany;spain;united kingdom,Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)];Drug: Simulect (basliximab),"
Inclusion Criteria:
- Patient greater than or equal to 18 years old.
- Patient is classified as high risk for acute allograft rejection of DGF. Must have
had at least 1 donor or 1 recipient variable for high risk.
- Patient will be a recipient of a solitary cadaveric renal allograft.
- Women of childbearing potential must have had a negative pregnancy test (serum or
urine).
- Man or woman agrees to practice medically acceptable contraception (i.e. barrier or
pharmacologic) for a minimum of 3 months following study drug administration. In
addition, women were recommended to practice contraception for 1 year following
transplantation, or per local standard.
- Patient agrees to participate in the study and sign an informed consent.
- Patient has no known contraindication to the administration of rabbit anti-thymocyte
globulin or basiliximab. Patient has no history of hypersensitivity to basiliximab.
- Patient is dialysis-dependent at the time immediately prior to transplantation.
Exclusion Criteria:
- Patient has received an investigational medication within the past 30 days.
- Patient has a history of malignancy within 2 years, with the exception of adequately
treated localized squamous basal cell carcinoma of the skin without evidence of
recurrence.
- Patient is currently abusing drugs or alcohol.
- Patient is known or suspected to have an active infection or be seropositive for
hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency
virus (HIV).
- Patient is a multiple organ transplant recipient.
- Patient is on any type of immunosuppression (i.e. prior transplant recipient still on
immunosuppression, or patient is receiving systemic steroids for any medical
condition).
- Patient, who, in the opinion of the investigator, has significant medical or
psychosocial problems or unstable disease states which would preclude enrollment.
Examples of significant medical problems include, but are not limited to, morbid
obesity or severe cardiac disease.
- Kidneys that are to be implanted en bloc or from donors less than 6 years old.
- Kidneys from donors that are known or suspected to have an active infection with or
be seropositive for HBsAg, hepatitis B core antibody (HBcAb), HCV, or HIV.
- Kidneys from donors that have received investigational therapies designed to reduce
the impact of ischemia reperfusion, DGF, or other donor-related immune events.
- Donor kidney is preserved by cold storage (with or without machine preservation) for
less than 16 hours, with the exception of kidneys from non-heart-beating donors or
kidneys from donors greater than 50 years old or donors with a SCr above 2.5mg/dL.
",NULL,"Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.",12-mo. safety & efficacy assessments including side effects and overall kidney transplant function.,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-05-31,2005-10-06,2005-10-06,240,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2000,2015-03-17,TRUE,FALSE,FALSE
8440,NCT01770379,NA,EUCTR2011-006058-94,NCT: 2012-10-16 ICTRP: 2012-07-19 DRKS: NA,1,1,NA,2,1,r,NA,2,1,3 points but no time frame or intervals,5,1,NA,5,1,NA,NCT: Actual 242 ICTRP: 234 DRKS: NA,242,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1080/03009742.2017.1390605,2017-10-06,2013-01-17,NA,2012-10-31,2015-05-31,Interventional,Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.,"A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents",Terminated,Phase 3,242,Actual,Novartis,Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).,Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP);Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI);Percentage of Participants Achieving ACR50,2011-006058-94;CAIN457F2311,Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFa Agents.,"A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents",;;;,;;;,Interventional,,Phase 3,2012-10-16,2012-10-20,242,Terminated,Novartis Pharmaceuticals,NULL,"united states;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;united states;ecuador;puerto rico;united states;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;united states;ecuador;puerto rico;united states;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;united states;ecuador;puerto rico;united states;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;argentina;brazil;colombia;czech republic;dominican republic;germany;greece;guatemala;india;italy;japan;korea, republic of;panama;portugal;south africa;united states;ecuador;puerto rico",Biological: Secukinumab (AIN457);Biological: Placebo;Biological: Secukinumab (AIN457);Biological: Placebo;Biological: Secukinumab (AIN457);Biological: Placebo;Biological: Secukinumab (AIN457);Biological: Placebo,"
Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised
criteria for at least 3 months •Disease activity defined by =6 tender joints out of 68 and
= 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR
Rheumatoid Factor positive AND WITH Either hsCRP = 10 mg/L OR ESR =28 mm/1st hr •Intake of
at least one anti-TNF-a agent such as etanercept, adalimumab, infliximab, certolizumab or
golimumab for at least 3 months before entering the study and to have experienced an
inadequate response to treatment or to have been intolerant to at least one administration
Exclusion Criteria:
- Current RA functional status class IV according to the ACR 1991 revised criteria
•Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17
receptor and/or any history of hypersensitivity to secukinumab or its excipient or to
drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria
may apply
;
Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised
criteria for at least 3 months •Disease activity defined by =6 tender joints out of 68 and
= 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR
Rheumatoid Factor positive AND WITH Either hsCRP = 10 mg/L OR ESR =28 mm/1st hr •Intake of
at least one anti-TNF-a agent such as etanercept, adalimumab, infliximab, certolizumab or
golimumab for at least 3 months before entering the study and to have experienced an
inadequate response to treatment or to have been intolerant to at least one administration
Exclusion Criteria:
- Current RA functional status class IV according to the ACR 1991 revised criteria
•Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17
receptor and/or any history of hypersensitivity to secukinumab or its excipient or to
drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria
may apply
;
Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised
criteria for at least 3 months •Disease activity defined by =6 tender joints out of 68 and
= 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR
Rheumatoid Factor positive AND WITH Either hsCRP = 10 mg/L OR ESR =28 mm/1st hr •Intake of
at least one anti-TNF-a agent such as etanercept, adalimumab, infliximab, certolizumab or
golimumab for at least 3 months before entering the study and to have experienced an
inadequate response to treatment or to have been intolerant to at least one administration
Exclusion Criteria:
- Current RA functional status class IV according to the ACR 1991 revised criteria
•Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17
receptor and/or any history of hypersensitivity to secukinumab or its excipient or to
drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria
may apply
;
Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised
criteria for at least 3 months •Disease activity defined by =6 tender joints out of 68 and
= 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR
Rheumatoid Factor positive AND WITH Either hsCRP = 10 mg/L OR ESR =28 mm/1st hr •Intake of
at least one anti-TNF-a agent such as etanercept, adalimumab, infliximab, certolizumab or
golimumab for at least 3 months before entering the study and to have experienced an
inadequate response to treatment or to have been intolerant to at least one administration
Exclusion Criteria:
- Current RA functional status class IV according to the ACR 1991 revised criteria
•Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17
receptor and/or any history of hypersensitivity to secukinumab or its excipient or to
drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria
may apply
",NULL,Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).;Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).,Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP);Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI);Percentage of Participants Achieving ACR50,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-10-31,2012-10-16,2012-10-16,242,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,2016-06-09,TRUE,FALSE,TRUE
13866,NCT00865501,NA,NCT00865501,NCT: 2009-03-18 ICTRP: 2009-03-18 DRKS: NA,1,0,"Maybe the paper is a byproduct of the registered trial, but it does not follow the registered design, interventions and outcomes.",2,1,NA,NA,2,0,NA; different intervention,3,0,"no AM, no metric",NA,NA,NA,NCT: Actual 50 ICTRP: 50 DRKS: NA,90,1,1,1,0,"Quadruple in register, but not mentions of blinding in article and since the intervention according to the article was placing the participants in different positions can not possibly be blinded","Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Probably open,worse,0,no intervention,ganzer Artikel,https://doi.org/10.1093/ajh/hpw199,2016-08-23,2009-03-19,NA,2008-03-31,2009-12-31,Interventional,Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease,Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease,Completed,Phase 3,50,Actual,University of Erlangen-Nürnberg Medical School,left ventricular mass,,KFO-TP5-I,Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease,Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease,,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 3,2009-03-18,2008-03-20,50,Completed,University of Erlangen-Nürnberg Medical School,NULL,germany,Drug: spironolactone;Drug: placebo,
Inclusion Criteria:
- Clinical diagnosis hypertension (BP higher than 139/89)
Exclusion Criteria:
- Antihypertensive pretreatment
- Contraindications against spironolactone
- Being unable to understand or comply with study procedures
,NULL,left ventricular mass,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-03-31,2009-03-18,2009-03-18,50,Interventional,TRUE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2008,2012-07-06,TRUE,FALSE,FALSE
15658,NCT00548704,NA,NCT00548704,NCT: 2007-10-23 ICTRP: 2007-10-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,Dosage and intervals taken from detailed description,0,NA,Section about interventions empty. Unclear from description,0,NA,Section about interventions empty. Unclear from description,NCT: Actual 57 ICTRP: 57 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome in title,kein Artikel,NA,NA,2007-10-24,NA,2002-04-30,2005-08-31,Interventional,A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines,A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents,Completed,Phase 2/Phase 3,57,Actual,Onxeo,NA,NA,TT02,A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracyclines,A Clinical Trial on Topotect® (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents,,,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 2/Phase 3,2007-10-23,2002-04-20,57,Completed,Onxeo,NULL,denmark;germany;italy;netherlands;poland;denmark;germany;italy;netherlands;poland,Drug: Dexrazoxane,"
Inclusion Criteria:
1. All cancer patients treated with anthracyclines
2. Informed consent must be obtained from the patient
3. Patients suspected to have been exposed to extravasation (leakage) of anthracycline,
defined as:
1. A primary assessment by the physician on duty, which would activate the standard
departmental procedure for treatment of anthracycline extravasation.
2. The presence of at least one of the following symptoms: pain, swelling or
redness at the site where the anthracycline leakage is suspected to have
occurred.
4. Suspicion of anthracycline extravasation from a central venous access device
5. The Topotect® infusion must be started < 6 hours after the accident
6. 18 years of age or older
7. Performance status (PS) < 2
Exclusion Criteria:
1. Known allergy towards dexrazoxane
2. Reasonable suspicion of extravasation by other compounds than anthracyclines through
the same intravenous access, e.g. vincristine, mitomycin, and vinorelbine, all of
which may cause ulceration
3. AST (aspartate aminotransferase) or ALT (alanine aminotransferase), bilirubin, LDH
(lactate dehydrogenase), alkaline phosphatase >3 x upper normal value
4. Neutrophils CTC (common toxicity criteria) = grade 2. (neutrophils 1.5 x 109/L,
=1,500/mm3)
5. Platelets CTC = grade 2. (platelets =75.0 x 109/L, <75,000/mm3).
6. Topical use of DMSO (dimethylsulfoxide) at the area of the accident
7. Administration of dexrazoxane within the last 3 weeks
8. Pregnant or nursing women
9. Women of childbearing age and potential, who do not use an efficient contraceptive
(e.g. the Pill or a diaphragm plus a spermicide) for at least 3 months prior to the
start of trial medication
",NULL,NULL,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-04-30,2007-10-23,2007-10-23,57,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,2015-10-20,TRUE,FALSE,FALSE
18769,NCT00053820,NA,NA,NCT: 2003-02-05 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage in description,3,NA,"no AM, no total duration. Information from detailed description.",4,NA,no AM,NCT: Anticipated 670 ICTRP: NA DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome in title,kein Artikel,NA,NA,2003-02-06,NA,2002-07-31,2006-12-31,Interventional,Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer,"A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma",Completed,Phase 3,670,Anticipated,National Cancer Institute (NCI),Survival,"Time to progression as measured by RECIST criteria;Comparison of toxicity levels (Grade III and IV);Comparison of quality of life before, during, after completion of study treatment;Impact of the treatment regimens on health economics",MRC-RE04;EORTC-30012;EU-20231;ISRCTN46518965;CDR0000269480,Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer,"A Randomized Controlled Trial of Interferon-alpha, Interleukin-2 and 5-Fluorouracil vs. Interferon-alpha Alone in Patients With Advanced Renal Cell Carcinoma",;,;,Interventional,"Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment",Phase 3,2003-02-05,2002-07-20,670,Completed,Medical Research Council,European Organisation for Research and Treatment of Cancer - EORTC,belgium;germany;netherlands;slovakia;belgium;germany;netherlands;slovakia,Biological: aldesleukin;Biological: recombinant interferon alfa;Drug: fluorouracil,"
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Advanced metastatic disease that requires treatment
- Measurable disease (single bone lesions not included)
- No brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 to 81
Performance status
- WHO 0-1
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No myocardial infarction within the past 6 months
- No unstable angina pectoris
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 6 months
after study participation
- No other concurrent disease or prior malignancy that would preclude study treatments
or comparisons
- No concurrent active infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior biologic therapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No prior endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Prior resection of the primary tumor recommended but not required
- No prior major organ allografts
",NULL,Survival,"Time to progression as measured by RECIST criteria;Comparison of toxicity levels (Grade III and IV);Comparison of quality of life before, during, after completion of study treatment;Impact of the treatment regimens on health economics",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-07-31,2003-02-05,2003-02-05,670,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,2013-12-18,TRUE,FALSE,FALSE
17525,NCT00258453,NA,NCT00258453,NCT: 2005-11-22 ICTRP: 2005-11-22 DRKS: NA,0,NA,Seems to be observational but registered as interventional without specific intervention.,2,NA,NA,NA,1,NA,"Various interventions mentioned. Nothing in the ""arms and interventions"" section.",2,NA,"no AM, no time frame, no measure (what is measured about the therapy strategies?)",3,NA,"No time frame, no measure",NCT: Anticipated 120 ICTRP: 120 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No intervention in title / should be identified as observational,kein Artikel,NA,NA,2005-11-24,NA,2001-05-31,2009-09-30,Interventional,Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma,"Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma",Completed,N/A,120,Anticipated,National Cancer Institute (NCI),NA,NA,CDR0000450768;EU-20537;GPOH-CRANIOPHARYNGIOMA-2000,Observation of Young Patients Who Are Undergoing Surgery for Craniopharyngioma,"Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma",,,Interventional,"Masking: Open Label, Primary Purpose: Diagnostic",N/A,2005-11-22,2001-05-20,120,Completed,Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany,NULL,austria;germany;sweden;switzerland;austria;germany;sweden;switzerland,Other: metabolic assessment;Other: physiologic testing;Procedure: biopsy;Procedure: computed tomography;Procedure: conventional surgery;Procedure: magnetic resonance imaging;Procedure: management of therapy complications;Procedure: psychosocial assessment and care;Procedure: quality-of-life assessment;Radiation: radiation therapy,"
DISEASE CHARACTERISTICS:
- Diagnosis of primary craniopharyngioma by MRI and CT scan (initial diagnosis)
- Patients with only cystic sellar or parasellar malformation (e.g., Rathke pouch
cysts or suprasellar cysts) are allowed but will undergo observation only
PATIENT CHARACTERISTICS:
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY: Not specified
",NULL,NULL,NULL,NCT00258453; GPOH-CRANIOPHARYNGIOMA-2000; EU-20537; CDR0000450768,2012-05-04,yes,Brain and Central Nervous System Tumors; Long-term Effects Secondary to Cancer Therapy in Children; Perioperative/Postoperative Complications; Psychosocial Effects of Cancer and Its Treatment; Weight Changes,Arm 1 Other: metabolic assessment; Arm 2 Other: physiologic testing; Arm 3 Procedure: biopsy; Arm 4 Procedure: computed tomography; Arm 5 Procedure: conventional surgery; Arm 6 Procedure: magnetic resonance imaging; Arm 7 Procedure: management of therapy complications; Arm 8 Procedure: psychosocial assessment and care; Arm 9 Procedure: quality-of-life assessment; Arm 10 Radiation: radiation therapy,Interventional,NA,Open (masking not used),NA,NA,N/A,NA,NA,Austria; Germany; Sweden; Switzerland,[---]* Aachen; [---]* Augsburg; [---]* Bad Mergentheim; [---]* Bamberg; [---]* Bayreuth; [---]* Berlin; [---]* Berlin; [---]* Berlin; [---]* Biefeld; [---]* Bonn; [---]* Bremen; [---]* Celle; [---]* Chemnitz; [---]* Coburg; [---]* Cologne; [---]* Cologne; [---]* Cottbus; [---]* Datteln; [---]* Detmold; [---]* Dresden,2001-05-31,NA,120,2009-09-01,"DISEASE CHARACTERISTICS:
- Diagnosis of primary craniopharyngioma by MRI and CT scan (initial diagnosis)
- Patients with only cystic sellar or parasellar malformation (e.g., Rathke pouch
cysts or suprasellar cysts) are allowed but will undergo observation only
PATIENT CHARACTERISTICS:
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY: Not specified
",NA,"Prospective, Multi-Center Survey Study of Children and Adolescents With Craniopharyngioma","Recruiting complete, follow-up complete",Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany; Klinikum Oldenburg; Klinikum Oldenburg,[---]*; [---]*; [---]*,Arm 1 Other: metabolic assessment; Arm 2 Other: physiologic testing; Arm 3 Procedure: biopsy; Arm 4 Procedure: computed tomography; Arm 5 Procedure: conventional surgery; Arm 6 Procedure: magnetic resonance imaging; Arm 7 Procedure: management of therapy complications; Arm 8 Procedure: psychosocial assessment and care; Arm 9 Procedure: quality-of-life assessment; Arm 10 Radiation: radiation therapy,2001-05-31,2005-11-22,2005-11-22,120,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2001,2013-08-01,TRUE,TRUE,FALSE
15683,NCT00544583,NA,NCT00544583,NCT: 2007-10-15 ICTRP: 2007-10-15 DRKS: NA,1,NA,NA,2,NA,NA,"""Patients undergoing primary and emergency midline laparotomy"" rated as sufficient",2,NA,NA,3,NA,"no AM, no measure",2,NA,"no AM, no metric, no measure",NCT: Anticipated 80 ICTRP: 80 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,No outcome in title,Studienprotokoll,https://doi.org/10.1186/1745-6215-13-72,NA,2007-10-16,NA,2007-11-30,2012-04-30,Interventional,Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy,Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study,Unknown status,Phase 2/Phase 3,80,Anticipated,Heidelberg University,Incisional hernia or burst abdomen within 12 months,Quality of Life,S206/2007,Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy,Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study,;;nuh.rahbari@med.uni-heidelberg.de;nuh.rahbari@med.uni-heidelberg.de,;;nuh.rahbari@med.uni-heidelberg.de;nuh.rahbari@med.uni-heidelberg.de,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment",Phase 2/Phase 3,2007-10-15,2007-11-20,80,Recruiting,Heidelberg University,NULL,germany,Procedure: Interrupted sutures;Procedure: Continuous sutures,"
Inclusion Criteria:
1. Preoperative Inclusion criteria:
- Age equal or greater than 18 years
- Expected survival time more than 12 months
- Patients undergoing primary and emergency midline laparotomy (patients with
prior laparoscopy (not colon resections) or minor abdominal operation (e.g.
appendectomy, cholecystectomy, hysterectomy, sectio) may be included into the
trial)
- Suspected septic abdominal focus (e.g. perforated stomach ulcer, perforated
diverticulitis)
- Informed consent
2. Intraoperative inclusion criteria before closure:
- Successful source control
- Abdominal lavage
Exclusion Criteria:
1. Preoperative exclusion criteria:
- Participation in another intervention-trial with interference of intervention
and outcome of this study
2. Intraoperative exclusion criteria before closure:
- Planned re-laparotomy
",NULL,Incisional hernia or burst abdomen within 12 months,Quality of Life,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-11-30,2007-10-15,2007-10-15,80,Interventional,TRUE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2007,2010-01-26,TRUE,FALSE,FALSE
5226,NCT02453386,NA,NCT02453386,NCT: 2015-05-21 ICTRP: 2015-05-21 DRKS: NA,1,NA,NA,1,NA,NA,"""Good response"" undefined",2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 449 ICTRP: 449 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Review,https://doi.org/10.3390/biom10050703,NA,2015-05-25,NA,2015-07-31,2018-01-12,Interventional,Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD)",Terminated,Phase 3,449,Actual,Biotie Therapies Inc.,Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time,Change in Good ON Time From Baseline to Week 24;Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function;Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl,2014-005630-60;TOZ-CL05,Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's Patients,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD)",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 3,2015-05-21,2015-07-20,449,Terminated,Biotie Therapies Inc.,NULL,united states;austria;canada;czechia;germany;italy;spain;austria;canada;czechia;germany;italy;spain;united states;czech republic,Drug: tozadenant;Drug: placebo,"
Inclusion Criteria:
- Patient understands study requirements and has given his/her written informed consent
on an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved
consent form.
- Parkinson's disease diagnosis consistent with UK Parkinson's Disease Society Brain
Bank Diagnostic criteria
- Minimum of 3 years since diagnosis.
- Meet Hoehn and Yahr PD stage
- Good response to levodopa
- Stable regimen of anti-PD medications
- Patients must have been taking a levodopa-containing anti-PD medication continuously
for at least the previous 12 months
- Patient has documented a minimum amount of Off time.
- If of childbearing potential (male and female) must use an acceptable method of
contraception
Exclusion Criteria:
- Previous tozadenant study participation
- Current or recent participation in another study.
- Secondary or atypical parkinsonism
- Neurosurgical intervention for PD
- Patient is taking apomorphine, budipine, istradefylline, tolcapone, or DUOPA™/Duodopa®
- Treatment with excluded medications
- Untreated or uncontrolled hyperthyroidism or hypothyroidism
- Clinically significant out-of-range laboratory
- MMSE out of range
- Current episode of major depression (stable treatment for depression is permitted).
- Recent suicide attempt or suicidal ideation type 4 or type 5 of the Columbia-Suicide
Severity Rating Scale (C-SSRS)
- Women lactating or pregnant
- Hypersensitivity to any components of tozadenant or excipients
- Abnormal findings on the physical or neurological examination, or medical history that
would make the patient unsuitable for the study
- History of hepatitis or cholangitis
",NULL,Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time,Change in Good ON Time From Baseline to Week 24;Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function;Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-07-31,2015-05-21,2015-05-21,449,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2019-03-25,TRUE,FALSE,TRUE
18712,NCT00069095,NA,NCT00069095,NCT: 2003-09-15 ICTRP: 2003-09-15 DRKS: NA,1,1,NA,1,1,NA,Criteria more specific in paper,2,1,NA,5,1,NA,4,0,no AM; not reported,NCT: Actual 2035 ICTRP: 2035 DRKS: NA,1401,1,1,NA,NA,NA; no info on blinding in article,"Double (Participant, Investigator)",No info,no_info,0,no outcome,ganzer Artikel,10.1200/JCO.2007.14.9930,2016-09-21,2003-09-18,NA,2003-07-31,2009-04-30,Interventional,A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer,A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) (XELOX) With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) (FOLFOX-4) With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer,Completed,Phase 3,2035,Actual,Hoffmann-La Roche,Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4;PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone,"PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4;PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4;PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4;PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4;Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4;Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone;Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone",NO16966,A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer,A 2x2 Factorial Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) (XELOX) With/Without Intravenous Bevacizumab (Q3W) Versus Bolus and Continuous Infusion Fluorouracil/Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) (FOLFOX-4) With/Without Intravenous Bevacizumab (Q2W) as First-line Treatment for Patients With Metastatic Colorectal Cancer,;;;,;;;,Interventional,,Phase 3,2003-09-15,2003-07-20,2035,Completed,Hoffmann-La Roche,NULL,"united states;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;united states;greece;united states;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;united states;greece;united states;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;united states;greece;united states;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;australia;austria;brazil;canada;china;czech republic;denmark;finland;france;germany;guatemala;hong kong;hungary;ireland;israel;italy;korea, republic of;mexico;new zealand;norway;panama;portugal;puerto rico;russian federation;south africa;spain;sweden;switzerland;taiwan;thailand;turkey;united kingdom;united states;greece",Drug: Oxaliplatin 130 mg/m^2;Drug: Capecitabine 1000 mg/m^2;Drug: Bevacizumab 7.5 mg/kg;Drug: Placebo for bevacizumab 7.5 mg/kg;Drug: Oxaliplatin 85 mg/m^2;Drug: Leucovorin 200 mg/m^2;Drug: Fluorouracil 400 mg/m^2;Drug: Bevacizumab 5 mg/kg;Drug: Placebo for bevacizumab 5 mg/kg;Drug: Oxaliplatin 130 mg/m^2;Drug: Capecitabine 1000 mg/m^2;Drug: Bevacizumab 7.5 mg/kg;Drug: Placebo for bevacizumab 7.5 mg/kg;Drug: Oxaliplatin 85 mg/m^2;Drug: Leucovorin 200 mg/m^2;Drug: Fluorouracil 400 mg/m^2;Drug: Bevacizumab 5 mg/kg;Drug: Placebo for bevacizumab 5 mg/kg;Drug: Oxaliplatin 130 mg/m^2;Drug: Capecitabine 1000 mg/m^2;Drug: Bevacizumab 7.5 mg/kg;Drug: Placebo for bevacizumab 7.5 mg/kg;Drug: Oxaliplatin 85 mg/m^2;Drug: Leucovorin 200 mg/m^2;Drug: Fluorouracil 400 mg/m^2;Drug: Bevacizumab 5 mg/kg;Drug: Placebo for bevacizumab 5 mg/kg;Drug: Oxaliplatin 130 mg/m^2;Drug: Capecitabine 1000 mg/m^2;Drug: Bevacizumab 7.5 mg/kg;Drug: Placebo for bevacizumab 7.5 mg/kg;Drug: Oxaliplatin 85 mg/m^2;Drug: Leucovorin 200 mg/m^2;Drug: Fluorouracil 400 mg/m^2;Drug: Bevacizumab 5 mg/kg;Drug: Placebo for bevacizumab 5 mg/kg,
Inclusion Criteria:
- Adult patients = 18 years of age.
- Metastatic colorectal cancer.
- = 1 target lesion.
Exclusion Criteria:
- Previous treatment with oxaliplatin or bevacizumab.
- Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
- Progressive disease during or within 6 months of completion of previous adjuvant
therapy.
;
Inclusion Criteria:
- Adult patients = 18 years of age.
- Metastatic colorectal cancer.
- = 1 target lesion.
Exclusion Criteria:
- Previous treatment with oxaliplatin or bevacizumab.
- Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
- Progressive disease during or within 6 months of completion of previous adjuvant
therapy.
;
Inclusion Criteria:
- Adult patients = 18 years of age.
- Metastatic colorectal cancer.
- = 1 target lesion.
Exclusion Criteria:
- Previous treatment with oxaliplatin or bevacizumab.
- Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
- Progressive disease during or within 6 months of completion of previous adjuvant
therapy.
;
Inclusion Criteria:
- Adult patients = 18 years of age.
- Metastatic colorectal cancer.
- = 1 target lesion.
Exclusion Criteria:
- Previous treatment with oxaliplatin or bevacizumab.
- Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
- Progressive disease during or within 6 months of completion of previous adjuvant
therapy.
,NULL,Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4;PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4;PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone,"PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4;PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4;PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4;PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4;Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4;Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone;Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone;Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4;Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-07-31,2003-09-15,2003-09-15,2035,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2016-08-26,TRUE,FALSE,FALSE
18889,NCT00040183,NA,NCT00040183,NCT: 2002-06-21 ICTRP: 2002-06-21 DRKS: NA,1,NA,NA,1,NA,NA,criteria for carcinoma,1,NA,no dosages,0,NA,information missing,0,NA,information missing,NCT: Actual 569 ICTRP: 569 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2002-06-25,NA,2001-11-29,2004-01-15,Interventional,"OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.","A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer",Completed,Phase 3,569,Actual,Astellas Pharma Inc,NA,NA,PA.3,"OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.","A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer",NULL,NULL,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double. ,Phase 3,2002-06-21,2001-11-29,569,Completed,OSI Pharmaceuticals,Canadian Cancer Trials Group,united states;argentina;australia;belgium;brazil;canada;chile;germany;greece;israel;italy;mexico;new zealand;poland;romania;singapore;united kingdom;argentina;australia;belgium;brazil;canada;chile;germany;greece;israel;italy;mexico;new zealand;poland;romania;singapore;united kingdom;united states,"Drug: Tarceva (erlotinib HCl, OSI-774)","
Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the
pancreas;cancer which is unresectable, locally advanced or metastatic.
Must have evidence of disease (clinical or radiological). Male or female, 18 years or
older. Patients may have received prior radiation treatment for management of local disease
providing that disease progression has been documented.
All toxicities have resolved, and the last fraction of radiation treatment was completed at
least 4 weeks prior to randomization.
Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or
gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'
",NULL,NULL,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-11-29,2002-06-21,2002-06-21,569,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2018-01-08,TRUE,FALSE,FALSE
15132,NCT00644293,NA,NCT00644293,NCT: 2008-03-19 ICTRP: 2008-03-19 DRKS: NA,1,1,NA,2,1,a,Criteria more specific in paper,2,1,NA,5,1,NA,1,1,"no AM, no metric, no measure of clinical response",NCT: Actual 598 ICTRP: 598 DRKS: NA,598,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1111/j.1469-0691.2009.02718.x,2009-12-01,2008-03-26,NA,2003-01-31,2004-04-30,Interventional,"A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults","A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults",Completed,Phase 3,598,Actual,Pfizer,bacteriologic response in the Bacteriologic per Protocol population,sponsor assessment of clinical response in the Bacteriologic per Protocol population;bacteriologic response for the remaining study populations;sponsor assessment of clinical response for the Bacteriologic per Protocol population;bacteriologic response for the Bacteriologic per Protocol population;summary of baseline susceptibilities;adverse events,A0661119,"A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults","A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A ß-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",Phase 3,2008-03-19,2003-01-20,598,Completed,Pfizer,NULL,united states;belgium;finland;france;germany;india;italy;netherlands;norway;united kingdom;united states;belgium;finland;france;germany;india;italy;netherlands;norway;united kingdom,Drug: azithromycin (Zithromax);Drug: placebo;Drug: azithromycin SR;Drug: placebo,"
Inclusion Criteria:
- Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS)
pharyngitis/tonsillitis and a positive rapid antigen detection test or positive
culture of the pharynx or tonsils for GABHS
Exclusion Criteria:
- Patients were excluded if they had treatment with any systemic antibiotic within the
previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known
carriers of GABHS.
",NULL,bacteriologic response in the Bacteriologic per Protocol population,sponsor assessment of clinical response in the Bacteriologic per Protocol population;bacteriologic response for the remaining study populations;sponsor assessment of clinical response for the Bacteriologic per Protocol population;bacteriologic response for the Bacteriologic per Protocol population;summary of baseline susceptibilities;adverse events,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-01-31,2008-03-19,2008-03-19,598,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2011-06-03,TRUE,FALSE,FALSE
19614,NCT02352948,NA,NA,NCT: 2015-01-28 ICTRP: NA DRKS: NA,1,1,NA,2,1,NA,NA,2,1,Dosages from PDF study protocol,5,1,NA,5,1,NA,NCT: Actual 597 ICTRP: NA DRKS: NA,595,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,ganzer Artikel,10.1016/j.annonc.2020.02.006,2020-02-20,2015-02-02,NA,2015-01-13,2021-06-30,Interventional,"A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer","A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).","Active, not recruiting",Phase 2,597,Actual,AstraZeneca,Overall Survival (OS);Progression-Free Survival (PFS),"OS, Contribution of the Components Analysis of Sub-study B;Percentage of Participants Alive at 12 Months (OS12);PFS, Contribution of the Components Analysis of Sub-study B;Objective Response Rate (ORR);Duration of Response (DoR);Percentage of Participants Alive and Progression Free at 6 Months (APF6);Percentage of Participants Alive and Progression Free at 12 Months (APF12);Time From Randomisation to Second Progression (PFS2) of Sub-study B",D4191C00004,"A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer","A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2015-01-28,2015-01-13,597,"Active, not recruiting",AstraZeneca,NULL,"united states;australia;belgium;bulgaria;canada;chile;czechia;france;germany;greece;hong kong;hungary;israel;italy;japan;korea, republic of;netherlands;poland;romania;russian federation;serbia;singapore;spain;taiwan;thailand;united kingdom;australia;belgium;bulgaria;canada;chile;czechia;france;germany;greece;hong kong;hungary;israel;italy;japan;korea, republic of;netherlands;poland;romania;russian federation;serbia;singapore;spain;taiwan;thailand;united kingdom;united states;argentina;czech republic;philippines;south africa;turkey",Drug: MEDI4736 (durvalumab);Drug: Vinorelbine;Drug: Gemcitabine;Drug: Erlotinib;Drug: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4);Drug: tremelimumab (anti-CTLA4),"
Inclusion Criteria:
- Aged at least 18 years
- Documented evidence of NSCLC (Stage IIIB/ IV disease)
- Disease progression or recurrence after both a platinum-based chemotherapy regimen and
at least 1 additional regimen for treatment of NSCLC
- World Health Organization (WHO) Performance Status of 0 or 1
- Estimated life expectancy more than 12 weeks
Exclusion Criteria:
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4
- Brain metastases or spinal cord compression unless asymptomatic, treated and stable
(not requiring steroids)
- Active or prior documented autoimmune disease within the past 2 years
- Evidence of severe or uncontrolled systemic disease, including active bleeding
diatheses or active infections including hepatitis B, C and HIV
- Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2
from previous anti-cancer therapy
- Known EGFR TK activating mutations or ALK rearrangements
- Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous
immunotherapy agent, or any unresolved irAE >Grade 1
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative
colitis)
",NULL,Overall Survival (OS);Progression-Free Survival (PFS),"OS, Contribution of the Components Analysis of Sub-study B;Percentage of Participants Alive at 12 Months (OS12);PFS, Contribution of the Components Analysis of Sub-study B;Objective Response Rate (ORR);Duration of Response (DoR);Percentage of Participants Alive and Progression Free at 6 Months (APF6);Percentage of Participants Alive and Progression Free at 12 Months (APF12);Time From Randomisation to Second Progression (PFS2) of Sub-study B",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-01-13,2015-01-28,2015-01-28,597,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2015,2020-11-20,TRUE,FALSE,TRUE
9017,NCT01662531,NA,EUCTR2011-006032-23,NCT: 2012-08-07 ICTRP: 2012-06-14 DRKS: NA,1,1,NCT used for scoring,2,1,NA,NA,2,1,Dosage from outcome,5,1,no AM,5,1,NA,NCT: Actual 27 ICTRP: 24 DRKS: NA,27,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1160/th16-03-0179,2016-03-03,2012-08-10,NA,2013-01-31,NA,Interventional,"A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B","A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B",Completed,Phase 3,27,Actual,CSL Behring,Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast);Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Number of Subjects Developing Inhibitors to Factor IX (FIX),"Number of Subjects With Treatment-related Adverse Events;Number of Subjects Developing Antibodies Against rIX-FP;Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis;Consumption of rIX-FP During Routine Prophylaxis",2011-006032-23;CSL654_3002,"A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B","A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B",;;;,;;;,Interventional,,Phase 3,2012-08-07,2013-01-20,27,Completed,CSL Behring,NULL,australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain;australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain;australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain;australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain;australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain;australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain;australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain;australia;austria;canada;czech republic;france;germany;israel;italy;russian federation;spain,Biological: rIX-FP;Biological: rIX-FP;Biological: rIX-FP;Biological: rIX-FP,"
Inclusion Criteria:
- Male subjects, younger than 12 years old.
- Severe hemophilia B (Factor IX [FIX] activity of = 2%).
- Body weight = 10 kg.
- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years).
- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
family history of inhibitors against FIX.
- Written informed consent for study participation.
Exclusion Criteria:
- Known hypersensitivity to any FIX product or hamster protein.
- Known congenital or acquired coagulation disorder other than congenital FIX
deficiency.
- Kidney or liver disease.
- Recent life-threatening bleeding episode.
;
Inclusion Criteria:
- Male subjects, younger than 12 years old.
- Severe hemophilia B (Factor IX [FIX] activity of = 2%).
- Body weight = 10 kg.
- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years).
- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
family history of inhibitors against FIX.
- Written informed consent for study participation.
Exclusion Criteria:
- Known hypersensitivity to any FIX product or hamster protein.
- Known congenital or acquired coagulation disorder other than congenital FIX
deficiency.
- Kidney or liver disease.
- Recent life-threatening bleeding episode.
;
Inclusion Criteria:
- Male subjects, younger than 12 years old.
- Severe hemophilia B (Factor IX [FIX] activity of = 2%).
- Body weight = 10 kg.
- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years).
- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
family history of inhibitors against FIX.
- Written informed consent for study participation.
Exclusion Criteria:
- Known hypersensitivity to any FIX product or hamster protein.
- Known congenital or acquired coagulation disorder other than congenital FIX
deficiency.
- Kidney or liver disease.
- Recent life-threatening bleeding episode.
;
Inclusion Criteria:
- Male subjects, younger than 12 years old.
- Severe hemophilia B (Factor IX [FIX] activity of = 2%).
- Body weight = 10 kg.
- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years).
- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
family history of inhibitors against FIX.
- Written informed consent for study participation.
Exclusion Criteria:
- Known hypersensitivity to any FIX product or hamster protein.
- Known congenital or acquired coagulation disorder other than congenital FIX
deficiency.
- Kidney or liver disease.
- Recent life-threatening bleeding episode.
",NULL,Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast);Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Number of Subjects Developing Inhibitors to Factor IX (FIX);Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast);Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product;Number of Subjects Developing Inhibitors to Factor IX (FIX),"Number of Subjects With Treatment-related Adverse Events;Number of Subjects Developing Antibodies Against rIX-FP;Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis;Consumption of rIX-FP During Routine Prophylaxis",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-01-31,2012-08-07,2012-08-07,27,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,2016-04-03,TRUE,FALSE,TRUE
6613,NCT02142725,NA,NA,NCT: 2014-05-15 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no measure,4,NA,no measure,NCT: Actual 468 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2014-05-20,NA,2014-07-21,2016-12-16,Interventional,Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis,"Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine",Terminated,Phase 3,468,Actual,Dr. Falk Pharma GmbH,Rate of clinical remission,Physician's global assessment at final visit;Quality of life;Rate of histologic remission;Rate of patients with clinical improvement;Time to first resolution of symptoms;Number of stools per week;Number of days with urgency per week;Rate of mucosal healing,2012-003702-27;PCG-2/UCA,Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis,"Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2014-05-15,2014-07-21,468,Terminated,Dr. Falk Pharma GmbH,NULL,germany;germany;germany;germany;germany,Drug: LT-02;Drug: LT-02;Drug: Placebo;Drug: LT-02;Drug: LT-02;Drug: Placebo;Drug: LT-02;Drug: LT-02;Drug: Placebo;Drug: LT-02;Drug: LT-02;Drug: Placebo,"
Inclusion Criteria:
- Established diagnosis of ulcerative colitis
- Active ulcerative colitis disease extent = 15 cm
- Active disease despite treatment with mesalamine
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,
microscopic colitis, diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis
- Colon resection
- Evidence of infectious colitis
- Celiac disease
- Bleeding hemorrhoids
- History or presence of ischemic heart disease, myocardial infarction, peripheral
arterial disease, ischemic stroke, or transient ischemic attack
- Any severe concomitant renal, endocrine, or psychiatric disorder
- Any relevant known systemic disease
- History of cancer in the last five years
- Abnormal hepatic function or liver cirrhosis
- Abnormal HbA1c at screening visit
- Patients with known hypersensitivity to soy
- Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
- Treatment with steroids/methotrexate/Tumor necrosis
factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
- Treatment with other investigational drug
- Existing or intended pregnancy or breast-feeding
;
Inclusion Criteria:
- Established diagnosis of ulcerative colitis
- Active ulcerative colitis disease extent = 15 cm
- Active disease despite treatment with mesalamine
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,
microscopic colitis, diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis
- Colon resection
- Evidence of infectious colitis
- Celiac disease
- Bleeding hemorrhoids
- History or presence of ischemic heart disease, myocardial infarction, peripheral
arterial disease, ischemic stroke, or transient ischemic attack
- Any severe concomitant renal, endocrine, or psychiatric disorder
- Any relevant known systemic disease
- History of cancer in the last five years
- Abnormal hepatic function or liver cirrhosis
- Abnormal HbA1c at screening visit
- Patients with known hypersensitivity to soy
- Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
- Treatment with steroids/methotrexate/Tumor necrosis
factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
- Treatment with other investigational drug
- Existing or intended pregnancy or breast-feeding
;
Inclusion Criteria:
- Established diagnosis of ulcerative colitis
- Active ulcerative colitis disease extent = 15 cm
- Active disease despite treatment with mesalamine
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,
microscopic colitis, diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis
- Colon resection
- Evidence of infectious colitis
- Celiac disease
- Bleeding hemorrhoids
- History or presence of ischemic heart disease, myocardial infarction, peripheral
arterial disease, ischemic stroke, or transient ischemic attack
- Any severe concomitant renal, endocrine, or psychiatric disorder
- Any relevant known systemic disease
- History of cancer in the last five years
- Abnormal hepatic function or liver cirrhosis
- Abnormal HbA1c at screening visit
- Patients with known hypersensitivity to soy
- Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
- Treatment with steroids/methotrexate/Tumor necrosis
factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
- Treatment with other investigational drug
- Existing or intended pregnancy or breast-feeding
;
Inclusion Criteria:
- Established diagnosis of ulcerative colitis
- Active ulcerative colitis disease extent = 15 cm
- Active disease despite treatment with mesalamine
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,
microscopic colitis, diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis
- Colon resection
- Evidence of infectious colitis
- Celiac disease
- Bleeding hemorrhoids
- History or presence of ischemic heart disease, myocardial infarction, peripheral
arterial disease, ischemic stroke, or transient ischemic attack
- Any severe concomitant renal, endocrine, or psychiatric disorder
- Any relevant known systemic disease
- History of cancer in the last five years
- Abnormal hepatic function or liver cirrhosis
- Abnormal HbA1c at screening visit
- Patients with known hypersensitivity to soy
- Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
- Treatment with steroids/methotrexate/Tumor necrosis
factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
- Treatment with other investigational drug
- Existing or intended pregnancy or breast-feeding
",NULL,Rate of clinical remission;Rate of clinical remission;Rate of clinical remission,Rate of patients with clinical improvement;Time to first resolution of symptoms;Number of stools per week;Number of days with urgency per week;Rate of mucosal healing;Rate of histologic remission;Physician's global assessment at final visit;Quality of life,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-07-21,2014-05-15,2014-05-15,468,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2014,2017-02-07,TRUE,FALSE,TRUE
17641,NCT00240474,NA,NCT00240474,NCT: 2005-10-14 ICTRP: 2005-10-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA 1000 ICTRP: 1000 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2005-10-18,NA,2002-12-31,2004-03-31,Interventional,A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study),"A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded End-point Evaluation. (ATHOS Study)",Completed,Phase 4,1000,NA,Boehringer Ingelheim,Change from baseline in the last 6-hour mean (relative to dose time) in SBP as measured by 24-hour ABPM at the end-of-study visit,"Change from baseline in DBP in the last six hours of the 24-hour dose period;Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period;Change from baseline SBP and DBP for other time intervals ( i.e. 24-hour mean, morning mean (06:00-11:59), daytime mean (06:00-21:59), and night-time mean (22:00-05:59));Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.;Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM).;Proportion of patients achieving a target response in SBP;Proportion of patients achieving SBP control;Proportion of patients achieving normal blood pressure;Proportion of patients achieving high-normal blood pressure;Change from baseline in trough seated SBP;Change from baseline in trough seated DBP;Safety and tolerability of the combination of telmisartan 80 mg and HCTZ 12.5 mg compared with amlodipine 10 mg and HCTZ 12.5 mg",502.400,A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study),"A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded End-point Evaluation. (ATHOS Study)",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 4,2005-10-14,2002-12-20,1000,Completed,Boehringer Ingelheim,NULL,belgium;denmark;finland;france;germany;ireland;italy;netherlands;south africa;spain;belgium;denmark;finland;france;germany;ireland;italy;netherlands;south africa;spain,Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg;Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg,"
Inclusion criteria:
- aged at least 60 years old
- mean SBP greater than 140 mmHg and mean DBP less than or equal to 95 mmHg
- 24-hour mean ambulatory SBP greater than 125 mmHg
- hypertensive patients not on current antihypertensive therapy or able to stop their
current treatment for a period of up to eighteen weeks
- willing and able to provide written informed consent
Exclusion criteria:
- women of child-bearing potential who are NOT practicing acceptable means of birth
control
- known or suspected secondary hypertension
- mean SBP equal to or greater than 200 mmHg
- hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- bilateral renal artery stenosis, renal artery stenosis in a solitary kidney,
patients post-renal transplant or with only one functioning kidney
- clinically relevant hypokalemia or hyperkalemia
- uncorrected volume or sodium depletion
- primary aldosteronism
- hereditary fructose intolerance
- biliary obstructive disorders
- patients who have previously experienced symptoms characteristic of angioedema during
treatment with ACE inhibitors or angiotensin-II receptor antagonists
- history of drug or alcohol dependency within the previous six months
- chronic administration of any medication known to affect blood pressure, other than
the trial medication
- concurrent participation in another clinical trial or any investigational therapy
within thirty days prior to signing the consent form.
- symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class
CHF II-IV)
- unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary
angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three
months prior to informed consent
- stroke less than six months prior to informed consent
- sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other
clinically relevant arrhythmias as determined by the investigator
- hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the
aortic or mitral valve
- insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled
for the previous three months
- night-shift workers who routinely sleep during the daytime and whose working hours
include midnight to 4:00 AM
- known allergic hypersensitivity to any component of the formulations under
investigation
- concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance
with study medication (defined as less than 80% or more than 120%) during the run-in
period
- current treatment with any antihypertensive agent
- any other clinical condition which, in the opinion of the investigator, would not
allow safe completion of the protocol and safe administration of telmisartan,
amlodipine or hydrochlorothiazide
",NULL,Change from baseline in the last 6-hour mean (relative to dose time) in SBP as measured by 24-hour ABPM at the end-of-study visit,"Change from baseline in DBP in the last six hours of the 24-hour dose period;Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period;Change from baseline SBP and DBP for other time intervals ( i.e. 24-hour mean, morning mean (06:00-11:59), daytime mean (06:00-21:59), and night-time mean (22:00-05:59));Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.;Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM).;Proportion of patients achieving a target response in SBP;Proportion of patients achieving SBP control;Proportion of patients achieving normal blood pressure;Proportion of patients achieving high-normal blood pressure;Change from baseline in trough seated SBP;Change from baseline in trough seated DBP;Safety and tolerability of the combination of telmisartan 80 mg and HCTZ 12.5 mg compared with amlodipine 10 mg and HCTZ 12.5 mg",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-12-31,2005-10-14,2005-10-14,1000,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,2013-10-31,TRUE,FALSE,FALSE
18649,NCT00079482,NA,NCT00079482,NCT: 2004-03-08 ICTRP: 2004-03-08 DRKS: NA,1,0,"Paper reports crossover of patients given specific circumstances, but not registered.",2,1,NA,NA,2,1,NA,4,1,no measure,4,1,no measure,NCT: Actual 224 ICTRP: 224 DRKS: NA,204,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,ganzer Artikel,https://doi.org/10.1182/blood-2010-08-301796,2010-08-11,2004-03-10,NA,2003-10-31,2010-01-31,Interventional,Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML),"A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations",Completed,Phase 2,224,Actual,Teva Pharmaceutical Industries,Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery.,- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity,C701a/204/ON/US,Study of CEP-701 (Lestaurtinib) in Patients With Acute Myeloid Leukemia (AML),"A Randomized, Open-Label Study of Oral CEP-701 Administered in Sequence With Standard Chemotherapy to Patients With Relapsed Acute Myeloid Leukemia (AML) Expressing FLT-3 Activating Mutations",NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 2,2004-03-08,2003-10-20,224,Completed,Cephalon,NULL,italy;new zealand;poland;romania;russian federation;spain;sweden;ukraine;united states;spain;sweden;ukraine;australia;canada;germany;israel;united states;australia;canada;germany;israel;italy;new zealand;poland;romania;russian federation,"Drug: CEP-701;Drug: high-dose cytarabine;Drug: Mitozantrone, Etoposide, Cytarabine (combination Chemotherapy)","
Inclusion criteria:
- cytological confirmation of AML;
- relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time
from first relapse to study entry (start of first course of induction chemotherapy)
must be no longer than 30days;
- confirmation of FLT-3 activating mutation positive status after point of initial
relapse;
- aged 18 years or older;
- written informed consent;
- ability to understand and comply with study restrictions;
- no comorbid conditions that would limit life expectancy to less than 3 months;
- ECOG Performance Score of 0, 1,or 2;
- women must be neither pregnant nor lactating, and either of non-childbearing
potential or using adequate contraception with a negative pregnancy test at study
entry
Exclusion criteria:
- bilirubin > 2x ULN;
- ALT/AST > 3x ULN;
- serum creatinine > 1.5 mg/dL;
- resting ejection fraction of left ventricle l < 45%(applies only to patients
scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC];
- untreated or progressive infection;
- any physical or psychiatric cdtn that may compromise participation in the study;
- known CNS involvement with AML;
- any previous treatment with a FLT-3 inhibitor;
- requires current treatment for HIV with protease inhibitors;
- active GI ulceration or bleeding;
- use of an investigational drug that is not expected to be cleared by the start of
CEP-701 treatment
",NULL,Determine whether CEP-701 given in sequence with induction chemotherapy increases the proportion of patients with relapsed AML who achieve a second complete remission or a complete remission with incomplete platelet count recovery.,- overall survival - event-free survival - remission duration - safety and tolerability of CEP-701 - pharmacokinetics of CEP-701 - CEP-701 inhibitory activity,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-10-31,2004-03-08,2004-03-08,224,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2016-07-19,TRUE,FALSE,FALSE
8893,NCT01686555,NA,NCT01686555,NCT: 2012-09-13 ICTRP: 2012-09-13 DRKS: NA,1,1,NA,2,1,NA,NA,1,NA,no dosage,4,1,no measure,4,1,no AM,NCT: Actual 97 ICTRP: 97 DRKS: NA,96,1,1,2,1,NA,"Triple (Participant, Care Provider, Investigator)","Triple (called ""double"" in the article)",ok,1,NA,ganzer Artikel,https://doi.org/10.1177/0961203317719334,2017-07-10,2012-09-18,NA,2012-11-30,2015-06-30,Interventional,"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)","Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)",Completed,Phase 1,97,Actual,AbbVie,The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199;Number of participants with Adverse Events;Physical Exam including vital signs;Clinical Lab Testing;Electrocardiogram (ECG) Measurements;Maximum observed serum concentration (Cmax) of ABT-199;Time to Cmax (Tmax) of ABT-199;The area under the time curve (AUC) of ABT-199,Measurement of lymphocyte depletion and recovery,2013-000328-33;M13-093,"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)","Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 1,2012-09-13,2012-11-20,97,Completed,"AbbVie (prior sponsor, Abbott)",NULL,united states;germany;mexico;puerto rico;germany;mexico;puerto rico;united states;united states;germany;mexico;puerto rico;germany;mexico;puerto rico;united states;united states;germany;mexico;puerto rico;germany;mexico;puerto rico;united states;united states;germany;mexico;puerto rico;germany;mexico;puerto rico;united states;united states;germany;mexico;puerto rico;germany;mexico;puerto rico;united states,Drug: ABT-199;Other: Placebo;Drug: ABT-199;Other: Placebo;Drug: ABT-199;Other: Placebo;Drug: ABT-199;Other: Placebo,"
Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus for at least 6 months.
- Documentation of at least one of the following: ANA titer >= 1:160 or positive
anti-dsDNA antibodies.
- Stable systemic lupus erythematosus medication regimen.
- Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion Criteria:
- Male.
- Drug-induced or highly active systemic lupus erythematosus.
- Significant autoimmune disease other than lupus.
- Significant, uncontrolled or unstable disease in any organ.
;
Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus for at least 6 months.
- Documentation of at least one of the following: ANA titer >= 1:160 or positive
anti-dsDNA antibodies.
- Stable systemic lupus erythematosus medication regimen.
- Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion Criteria:
- Male.
- Drug-induced or highly active systemic lupus erythematosus.
- Significant autoimmune disease other than lupus.
- Significant, uncontrolled or unstable disease in any organ.
;
Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus for at least 6 months.
- Documentation of at least one of the following: ANA titer >= 1:160 or positive
anti-dsDNA antibodies.
- Stable systemic lupus erythematosus medication regimen.
- Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion Criteria:
- Male.
- Drug-induced or highly active systemic lupus erythematosus.
- Significant autoimmune disease other than lupus.
- Significant, uncontrolled or unstable disease in any organ.
;
Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus for at least 6 months.
- Documentation of at least one of the following: ANA titer >= 1:160 or positive
anti-dsDNA antibodies.
- Stable systemic lupus erythematosus medication regimen.
- Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion Criteria:
- Male.
- Drug-induced or highly active systemic lupus erythematosus.
- Significant autoimmune disease other than lupus.
- Significant, uncontrolled or unstable disease in any organ.
",NULL,Number of participants with Adverse Events;Physical Exam including vital signs;Clinical Lab Testing;Electrocardiogram (ECG) Measurements;Maximum observed serum concentration (Cmax) of ABT-199;Time to Cmax (Tmax) of ABT-199;The area under the time curve (AUC) of ABT-199;The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199;Number of participants with Adverse Events;Physical Exam including vital signs;Clinical Lab Testing;Electrocardiogram (ECG) Measurements;Maximum observed serum concentration (Cmax) of ABT-199;Time to Cmax (Tmax) of ABT-199;The area under the time curve (AUC) of ABT-199;The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199;Number of participants with Adverse Events;Physical Exam including vital signs;Clinical Lab Testing;Electrocardiogram (ECG) Measurements;Maximum observed serum concentration (Cmax) of ABT-199;Time to Cmax (Tmax) of ABT-199;The area under the time curve (AUC) of ABT-199;The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199,Measurement of lymphocyte depletion and recovery,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-11-30,2012-09-13,2012-09-13,97,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,2017-11-16,TRUE,FALSE,FALSE
14513,NCT00751231,NA,NCT00751231,NCT: 2008-09-10 ICTRP: 2008-09-10 DRKS: NA,1,1,NA,2,1,a,Criteria more specific in paper,2,1,NA,NA,NA,NA,NA,NA,NA,NCT: Actual 652 ICTRP: 652 DRKS: NA,652,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Double (Participant, Investigator)",worse,1,NA,ganzer Artikel,https://doi.org/10.1161/circinterventions.111.964197,2011-04-11,2008-09-11,NA,2008-12-31,2010-04-30,Interventional,"A Phase 2 Safety and Efficacy Study of PRT060128, a Novel Intravenous and Oral P2Y12 Inhibitor, in Non-Urgent PCI","A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12 Inhibitor, vs Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent PCI",Completed,Phase 2,652,Actual,Portola Pharmaceuticals,"The study is not powered to examine a pre-specified endpoint; rather it is designed to explore a number of analyses to understand the clinical efficacy, biological activity, and tolerability and safety of PRT060128 in patients undergoing non-urgent PCI",,2008-001352-51;07-116,"A Phase 2 Safety and Efficacy Study of PRT060128, a Novel Intravenous and Oral P2Y12 Inhibitor, in Non-Urgent PCI","A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12 Inhibitor, vs Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent PCI",;;;;;;;;;;;;;;,;;;;;;;;;;;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 2,2008-09-10,2008-12-20,652,Completed,Portola Pharmaceuticals,NULL,united states;austria;canada;germany;poland;austria;canada;germany;poland;united states;united states;austria;canada;germany;poland;austria;canada;germany;poland;united states;united states;austria;canada;germany;poland;austria;canada;germany;poland;united states;united states;austria;canada;germany;poland;austria;canada;germany;poland;united states;united states;austria;canada;germany;poland;austria;canada;germany;poland;united states,Drug: clopidogrel;Drug: PRT060128;Drug: clopidogrel;Drug: PRT060128;Drug: clopidogrel;Drug: PRT060128;Drug: clopidogrel;Drug: PRT060128,"
Inclusion Criteria:
- The patient is scheduled to undergo non-urgent PCI
- The patient is between 18 and 75 years of age (inclusive) and willing to comply with
the protocol
- Women of childbearing potential must have a negative serum or urine pregnancy test
within 24 hours of dosing. All patients must agree to use double barrier contraception
during the study and for at least 4 weeks after their last dose.
- The patient or legally acceptable representative is able to read and give written
informed consent and has signed an informed consent form approved by the
Investigator's IRB/IEC
Exclusion Criteria:
- Estimated or measured weight < 55 kg
- Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation
myocardial infarction (STEMI) within 7 days prior to PCI
- Chronic total occlusion or unprotected left main stenting
- Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or
hemodynamic support)
- Uncontrolled hypertension at the time of initial study drug administration defined as
measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
- Planned staged PCI
- Planned surgery during the study period
- Planned GP IIb/IIIa use
- Patient has received a clopidogrel loading dose (=300 mg) within 7 days prior to
randomization; patients on maintenance clopidogrel may be enrolled
- The planned administration of the study-specified clopidogrel loading dose is >12
hours prior to PCI
- Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g.,
warfarin) within the 7 days prior to PCI
- Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
- Anemia with hemoglobin level < 10 g/dL
- Thrombocytopenia (platelet count < 100,000/mm3)
- ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic
dysfunction
- Facial or head trauma within the last 30 days
- Intraocular hemorrhage within the last 30 days
- Gastrointestinal bleeding within the last 30 days
- Active bleeding, or history of a bleeding disorder or known intracranial vascular
malformation
- History of any prior ischemic stroke or TIA within the last 5 years or intracranial
hemorrhage, neoplasm, or arteriovenous malformation
- Known allergy or contraindication to the components of PRT060128, aspirin, heparin,
clopidogrel, glycoprotein IIb/IIIa inhibitors, or to any contrast media
- Participation in any investigational drug study within 30 days prior to enrollment.
Participation in a device trial prior to enrollment is acceptable
- Prior participation in any study involving PRT060128
- Any condition which could interfere with, or the treatment for which might interfere
with, the conduct of the study or which would, in the opinion of the Investigator,
unacceptably increase the patient's risk by participating in the study. This would
include, but is not limited to alcoholism, drug dependency or abuse, psychiatric
disease, epilepsy or any unexplained blackouts
;
Inclusion Criteria:
- The patient is scheduled to undergo non-urgent PCI
- The patient is between 18 and 75 years of age (inclusive) and willing to comply with
the protocol
- Women of childbearing potential must have a negative serum or urine pregnancy test
within 24 hours of dosing. All patients must agree to use double barrier contraception
during the study and for at least 4 weeks after their last dose.
- The patient or legally acceptable representative is able to read and give written
informed consent and has signed an informed consent form approved by the
Investigator's IRB/IEC
Exclusion Criteria:
- Estimated or measured weight < 55 kg
- Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation
myocardial infarction (STEMI) within 7 days prior to PCI
- Chronic total occlusion or unprotected left main stenting
- Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or
hemodynamic support)
- Uncontrolled hypertension at the time of initial study drug administration defined as
measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
- Planned staged PCI
- Planned surgery during the study period
- Planned GP IIb/IIIa use
- Patient has received a clopidogrel loading dose (=300 mg) within 7 days prior to
randomization; patients on maintenance clopidogrel may be enrolled
- The planned administration of the study-specified clopidogrel loading dose is >12
hours prior to PCI
- Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g.,
warfarin) within the 7 days prior to PCI
- Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
- Anemia with hemoglobin level < 10 g/dL
- Thrombocytopenia (platelet count < 100,000/mm3)
- ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic
dysfunction
- Facial or head trauma within the last 30 days
- Intraocular hemorrhage within the last 30 days
- Gastrointestinal bleeding within the last 30 days
- Active bleeding, or history of a bleeding disorder or known intracranial vascular
malformation
- History of any prior ischemic stroke or TIA within the last 5 years or intracranial
hemorrhage, neoplasm, or arteriovenous malformation
- Known allergy or contraindication to the components of PRT060128, aspirin, heparin,
clopidogrel, glycoprotein IIb/IIIa inhibitors, or to any contrast media
- Participation in any investigational drug study within 30 days prior to enrollment.
Participation in a device trial prior to enrollment is acceptable
- Prior participation in any study involving PRT060128
- Any condition which could interfere with, or the treatment for which might interfere
with, the conduct of the study or which would, in the opinion of the Investigator,
unacceptably increase the patient's risk by participating in the study. This would
include, but is not limited to alcoholism, drug dependency or abuse, psychiatric
disease, epilepsy or any unexplained blackouts
;
Inclusion Criteria:
- The patient is scheduled to undergo non-urgent PCI
- The patient is between 18 and 75 years of age (inclusive) and willing to comply with
the protocol
- Women of childbearing potential must have a negative serum or urine pregnancy test
within 24 hours of dosing. All patients must agree to use double barrier contraception
during the study and for at least 4 weeks after their last dose.
- The patient or legally acceptable representative is able to read and give written
informed consent and has signed an informed consent form approved by the
Investigator's IRB/IEC
Exclusion Criteria:
- Estimated or measured weight < 55 kg
- Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation
myocardial infarction (STEMI) within 7 days prior to PCI
- Chronic total occlusion or unprotected left main stenting
- Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or
hemodynamic support)
- Uncontrolled hypertension at the time of initial study drug administration defined as
measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
- Planned staged PCI
- Planned surgery during the study period
- Planned GP IIb/IIIa use
- Patient has received a clopidogrel loading dose (=300 mg) within 7 days prior to
randomization; patients on maintenance clopidogrel may be enrolled
- The planned administration of the study-specified clopidogrel loading dose is >12
hours prior to PCI
- Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g.,
warfarin) within the 7 days prior to PCI
- Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
- Anemia with hemoglobin level < 10 g/dL
- Thrombocytopenia (platelet count < 100,000/mm3)
- ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic
dysfunction
- Facial or head trauma within the last 30 days
- Intraocular hemorrhage within the last 30 days
- Gastrointestinal bleeding within the last 30 days
- Active bleeding, or history of a bleeding disorder or known intracranial vascular
malformation
- History of any prior ischemic stroke or TIA within the last 5 years or intracranial
hemorrhage, neoplasm, or arteriovenous malformation
- Known allergy or contraindication to the components of PRT060128, aspirin, heparin,
clopidogrel, glycoprotein IIb/IIIa inhibitors, or to any contrast media
- Participation in any investigational drug study within 30 days prior to enrollment.
Participation in a device trial prior to enrollment is acceptable
- Prior participation in any study involving PRT060128
- Any condition which could interfere with, or the treatment for which might interfere
with, the conduct of the study or which would, in the opinion of the Investigator,
unacceptably increase the patient's risk by participating in the study. This would
include, but is not limited to alcoholism, drug dependency or abuse, psychiatric
disease, epilepsy or any unexplained blackouts
;
Inclusion Criteria:
- The patient is scheduled to undergo non-urgent PCI
- The patient is between 18 and 75 years of age (inclusive) and willing to comply with
the protocol
- Women of childbearing potential must have a negative serum or urine pregnancy test
within 24 hours of dosing. All patients must agree to use double barrier contraception
during the study and for at least 4 weeks after their last dose.
- The patient or legally acceptable representative is able to read and give written
informed consent and has signed an informed consent form approved by the
Investigator's IRB/IEC
Exclusion Criteria:
- Estimated or measured weight < 55 kg
- Acute non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation
myocardial infarction (STEMI) within 7 days prior to PCI
- Chronic total occlusion or unprotected left main stenting
- Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or
hemodynamic support)
- Uncontrolled hypertension at the time of initial study drug administration defined as
measured systolic blood pressure > 190 mm Hg or diastolic blood pressure > 108 mm Hg
- Planned staged PCI
- Planned surgery during the study period
- Planned GP IIb/IIIa use
- Patient has received a clopidogrel loading dose (=300 mg) within 7 days prior to
randomization; patients on maintenance clopidogrel may be enrolled
- The planned administration of the study-specified clopidogrel loading dose is >12
hours prior to PCI
- Administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g.,
warfarin) within the 7 days prior to PCI
- Estimated creatinine clearance (e.g. Cockcroft-Gault) < 45 mL/min
- Anemia with hemoglobin level < 10 g/dL
- Thrombocytopenia (platelet count < 100,000/mm3)
- ALT and/or AST > 2.5 x the ULN or other indication of clinically significant hepatic
dysfunction
- Facial or head trauma within the last 30 days
- Intraocular hemorrhage within the last 30 days
- Gastrointestinal bleeding within the last 30 days
- Active bleeding, or history of a bleeding disorder or known intracranial vascular
malformation
- History of any prior ischemic stroke or TIA within the last 5 years or intracranial
hemorrhage, neoplasm, or arteriovenous malformation
- Known allergy or contraindication to the components of PRT060128, aspirin, heparin,
clopidogrel, glycoprotein IIb/IIIa inhibitors, or to any contrast media
- Participation in any investigational drug study within 30 days prior to enrollment.
Participation in a device trial prior to enrollment is acceptable
- Prior participation in any study involving PRT060128
- Any condition which could interfere with, or the treatment for which might interfere
with, the conduct of the study or which would, in the opinion of the Investigator,
unacceptably increase the patient's risk by participating in the study. This would
include, but is not limited to alcoholism, drug dependency or abuse, psychiatric
disease, epilepsy or any unexplained blackouts
",NULL,"The study is not powered to examine a pre-specified endpoint; rather it is designed to explore a number of analyses to understand the clinical efficacy, biological activity, and tolerability and safety of PRT060128 in patients undergoing non-urgent PCI;The study is not powered to examine a pre-specified endpoint; rather it is designed to explore a number of analyses to understand the clinical efficacy, biological activity, and tolerability and safety of PRT060128 in patients undergoing non-urgent PCI;The study is not powered to examine a pre-specified endpoint; rather it is designed to explore a number of analyses to understand the clinical efficacy, biological activity, and tolerability and safety of PRT060128 in patients undergoing non-urgent PCI",NULL,,2012-03-29,yes,[generalization I48: Atrial fibrillation and flutter],Arm 1 electrical cardioversion of atrial fibrillation; Arm 2 defirbrillation of atrial fibrillation,Interventional,Randomized controlled trial,Blinded,Active control (effective treament of control group),Parallel,N/A,Induction of ventricular fibbrilation or ventricular tachycardia during treatment,"Incidence of procedural embolism, non sustained ventricular tachycardia, asystole, bradycardia",Germany,University Medical Center Koeln; Doctor's Practice Köln-Sülz,2008-02-19,Actual,300,2015-10-15,all patients independent of the underlying cardiac disease,1. latent or overt thyroid dysfunction
2. serum potassium levels below 4 mmol/l
3. clotting inhibitionout of range
4. Detection of left atrial thrombus or tumor
5. Lack of patient's competence,Eletrical cardioversion versus defibrillation of atrial fibrilation - a clinical trial,"Recruiting complete, follow-up complete",Herz- und Lungenpraxis; Praxis für herz- und Lungenkrankheiten; Klinik III für Innere Medizin
Unikliniken Köln,info@damianfranzen.de; info@damianfranzen.de; christian.keller@uk-koeln.de,Arm 1 electrical cardioversion of atrial fibrillation; Arm 2 defirbrillation of atrial fibrillation,2008-12-31,2008-09-10,2008-09-10,652,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2008,2017-09-20,TRUE,TRUE,TRUE
18703,NCT00070590,NA,NCT00070590,NCT: 2003-10-06 ICTRP: 2003-10-06 DRKS: NA,1,1,NA,1,1,a,criteria more specific in paper,1,1,NA,3,1,"no AM, no time frame",3,1,"no AM, no time frame",NCT: NA 132 ICTRP: 132 DRKS: NA,163,1,1,2,1,NA,Double,Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1002/art.27466,2009-04-08,2003-10-08,NA,2003-07-31,2005-09-30,Interventional,Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma,"A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis",Completed,Phase 2/Phase 3,132,NA,Actelion,Change from baseline to End-of-Study in 6-minute walk distance.,Time to death (all causes) or to worsening of PFTs up to End-of-Study.;Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline ≥ 10% in FVC OR decrease from baseline ≥ 15% in DLco AND ≥ 6% in FVC,BUILD 2;AC-052-330,Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma,"A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis",NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 2/Phase 3,2003-10-06,2003-07-20,132,Completed,Actelion,NULL,united states;france;germany;israel;italy;netherlands;sweden;switzerland;united kingdom;united states;france;germany;israel;italy;netherlands;sweden;switzerland;united kingdom,Drug: Bosentan,"
Main inclusion criteria:
- Systemic Sclerosis diffuse or limited
- Significant Interstitial Lung Disease on HRCTscan
- DLco < 80% predicted
- Dyspnea on exertion
- Walk not limited by musculoskeletal reasons
Main exclusion criteria:
- Interstitial Lung Disease due to other conditions than SSc
- End stage restrictive or obstructive lung disease
- Severe cardiac or renal diseases
- Significant pulmonary arterial hypertension
- Smoker (> 5cig./day)
- Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids
(within 4 weeks of randomization)
",NULL,Change from baseline to End-of-Study in 6-minute walk distance.,Time to death (all causes) or to worsening of PFTs up to End-of-Study.;Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline = 10% in FVC OR decrease from baseline = 15% in DLco AND = 6% in FVC,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-07-31,2003-10-06,2003-10-06,132,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2010-02-11,TRUE,FALSE,FALSE
17438,NCT00271713,NA,NCT00271713,NCT: 2006-01-03 ICTRP: 2006-01-03 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,3,1,"no AM, no measure. Multiple abbreviations that are not explained: ""BV/TV and trab. Sp. measured by 3D pQCT device"".",NA,NA,NA,NCT: Actual 70 ICTRP: 70 DRKS: NA,70,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Called ""double"" in the article, but investigator was also blinded",worse,1,NA,ganzer Artikel,https://doi.org/10.1016/j.bone.2011.10.027,2011-07-09,2006-01-04,NA,2006-03-31,2007-09-30,Interventional,Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D),Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures,Completed,Phase 4,70,Actual,"Charite University, Berlin, Germany",BV/TV and trab. Sp. measured by 3D pQCT device,,ML 19472,Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D),Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures,,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 4,2006-01-03,2006-03-20,70,Completed,"Charite University, Berlin, Germany",NULL,germany,"Drug: ibandronate, calcium and vitamin D;Drug: placebo,calcium and vitamin D","
Inclusion Criteria:
- Age between 60 and 75 years
- Menopause > 5 years
- Spine (L1 - L4) or hip BMD = -2.0 and > -3.5 SD T-score measured by DXA
- Patients who, in the opinion of the investigator, are able and willing to comply with
the protocol for its duration
- Written informed consent
- 3DpQCT measurable at both skeletal sites, distal tibia and radius
Exclusion Criteria:
- Spine or hip BMD = -3,5 SD T-Score measured by DXA
- Vertebral fractures
- Multiple (>2) low trauma peripheral fractures
- Disease/disorder known to influence bone metabolism
- History of major upper gastro-intestinal (GI) disease
- Diagnosed malignant disease within the previous 10 years
- Previous treatment with a bisphoshonate at any time
- Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the
last 12 months, or for more than 2 years (total duration)
- Treatment with PTH and similar agents or strontium ranelate at any time
- Treatment with other drugs affecting bone metabolism within the last 6 months
- Chronic systemic corticosteroid treatment
- Estrogens, progestins, SERMs, anabolic steroids, active vitamin D
analogues/metabolites, calcitonin
- Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
- Total serum calcium < 2.2 mmol/l or > 2.6 mmol/l
- Vitamin D deficiency (serum 25-hydroxy vitamin D < 12 ng/ ml)
- ALT above triple upper limit of normal range
- Renal impairment (serum creatinine > 210 µmol/l)
- Contra-indications for ibandronate, calcium or vitamin D
- Employees of the Centre for Muscle and Bone Research, or their relatives
",NULL,BV/TV and trab. Sp. measured by 3D pQCT device,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-03-31,2006-01-03,2006-01-03,70,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2006,2009-01-27,TRUE,FALSE,TRUE
13426,NCT00939939,NA,NCT00939939,NCT: 2009-07-14 ICTRP: 2009-07-14 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no AM,NCT: Actual 3 ICTRP: 3 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no indication,kein Artikel,NA,NA,2009-07-15,NA,2010-03-31,2011-05-31,Interventional,Effect of Sitagliptin on Postprandial Lipoprotein Metabolism,NA,Terminated,Phase 4,3,Actual,Ludwig-Maximilians - University of Munich,incremental area under the triglyceride curve (iAUC-TG),LDL-cholesterol;HDL-cholesterol;VLDL-cholesterol;triglycerides;area under the triglyceride curve (AUC-TG);area under the VLDL-triglyceride curve (AUC-VLDL-TG);incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG);glucose;insulin;HOMA;HbA1c;interleukin-6;hs-CRP,KP MSD 01-08,Effect of Sitagliptin on Postprandial Lipoprotein Metabolism,,NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 4,2009-07-14,2010-03-20,3,Terminated,Ludwig-Maximilians - University of Munich,NULL,germany,Drug: sitagliptin;Drug: glimepiride,
Inclusion Criteria:
- type 2 diabetes
- dietary therapy
Exclusion Criteria:
- lipid-lowering therapy
- anti-hyperglycemic drug therapy
,NULL,incremental area under the triglyceride curve (iAUC-TG),LDL-cholesterol;HDL-cholesterol;VLDL-cholesterol;triglycerides;area under the triglyceride curve (AUC-TG);area under the VLDL-triglyceride curve (AUC-VLDL-TG);incremental area under the VLDL-triglyceride curve (iAUC-VLDL-TG);glucose;insulin;HOMA;HbA1c;interleukin-6;hs-CRP,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-03-31,2009-07-14,2009-07-14,3,Interventional,TRUE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2010,2011-06-24,TRUE,FALSE,FALSE
11034,NCT01326208,NA,NCT01326208,NCT: 2010-07-15 ICTRP: 2010-07-15 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,Names of PEEP titration methods considered specific enough. No duration of treatment.,2,NA,"no AM, no metric, no measure",2,NA,NA,NCT: Anticipated 40 ICTRP: 40 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Editorial,https://doi.org/10.1016/j.ccm.2014.08.010,NA,2011-03-30,NA,2011-03-31,2013-06-30,Interventional,Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury,"Influence of Different Strategies to Optimize Positive End-expiratory Pressure on Pulmonary Gas Exchange, Perfusion/Ventilation Matching and Homogeneity of Ventilation in Patients With Acute Lung Injury",Unknown status,Phase 2,40,Anticipated,"University Hospital, Bonn",homogeneity of regional ventilation delay,"pulmonary gas exchange, lung mechanics and ventilation/perfusion matching",EIT-PEEP-2010,Strategies to Optimize Positive End-expiratory Pressure (PEEP) in Patients With Acute Lung Injury,"Influence of Different Strategies to Optimize Positive End-expiratory Pressure on Pulmonary Gas Exchange, Perfusion/Ventilation Matching and Homogeneity of Ventilation in Patients With Acute Lung Injury",;;christian.putensen@ukb.uni-bonn.de;christian.putensen@ukb.uni-bonn.de,;;christian.putensen@ukb.uni-bonn.de;christian.putensen@ukb.uni-bonn.de,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment",Phase 2,2010-07-15,2011-03-20,40,Recruiting,"University Hospital, Bonn",NULL,germany,Procedure: PEEP titration,"
Inclusion Criteria:
- acute lung injury, need for optimization of ventilatory settings
Exclusion Criteria:
- preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical
instability, increased intracranial pressure
",NULL,homogeneity of regional ventilation delay,"pulmonary gas exchange, lung mechanics and ventilation/perfusion matching",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-03-31,2010-07-15,2010-07-15,40,Interventional,TRUE,FALSE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2011,2011-03-29,TRUE,FALSE,FALSE
13775,NCT00879008,NA,NCT00879008,NCT: 2009-04-08 ICTRP: 2009-04-08 DRKS: NA,1,NA,NA,2,NA,NA,"Very simple design, so no measures necessary",NA,NA,NA,1,NA,NA,NA,NA,NA,NCT: Actual 345 ICTRP: 345 DRKS: NA,NA,1,NA,NA,NA,Observational cohort study,NA,NA,NA,0,No outcome in title,kein Artikel,NA,NA,2009-04-09,NA,2009-12-31,2010-08-31,Observational,SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB),SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB,Completed,NA,345,Actual,Bayer,Effectiveness and tolerance of/to the different therapies;Possible hospitalisation rate,,AX0710DE;12629,SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB),SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB,,,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2009-04-08,2009-12-20,345,Completed,Bayer,NULL,germany,"Drug: Moxifloxacin (Avelox, BAY12-8039)",
Inclusion Criteria:
- Acute exacerbation of chronic bronchitis from Anthonisen type I or II
- FEV1 of < 50 %
- Patient must be ensured in the statutory health insurance
- Further contraindications of the prescribed pharmaceutical products must be
considered
Exclusion Criteria:
- Patients who change from one cohort to the other
,NULL,Effectiveness and tolerance of/to the different therapies;Possible hospitalisation rate,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-12-31,2009-04-08,2009-04-08,345,Observational,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2009,2014-06-20,TRUE,FALSE,FALSE
18909,NCT00032734,NA,NCT00032734,NCT: 2002-03-29 ICTRP: 2002-03-29 DRKS: NA,1,NA,NA,0,NA,NA,no info,1,NA,NA,2,NA,"no AM, no metric, no time frame",1,NA,"no AM, no metric, no measure, no time frame",NCT: Actual 35 ICTRP: 35 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2002-04-01,NA,2001-06-30,2003-07-31,Interventional,Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.",Completed,Phase 2,35,Actual,Sanofi,serum sodium concentration,safety assessment,SR121463;LTS5066;LTS10208;DFI4488,Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalation, Multicenter Study Evaluating the Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion.",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 2,2002-03-29,2001-06-20,35,Completed,Sanofi,NULL,belgium;france;germany;hungary;belgium;france;germany;hungary;united states;canada,Drug: satavaptan (SR121463B),
SIADH of any origin
,NULL,serum sodium concentration,safety assessment,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-06-30,2002-03-29,2002-03-29,35,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2008-06-16,TRUE,FALSE,TRUE
9599,NCT01559103,NA,NCT01559103,NCT: 2012-03-19 ICTRP: 2012-03-19 DRKS: NA,1,NA,NA,1,NA,NA,Diagnosis according to which criteria?,2,NA,NA,3,NA,"no AM, no metric",5,NA,NA,NCT: Actual 39 ICTRP: 39 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Review,https://doi.org/10.1007/s40259-018-0320-3,NA,2012-03-21,NA,2012-05-31,2014-02-28,Interventional,Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients,"A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)",Terminated,Phase 1,39,Actual,AstraZeneca,"Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables.","Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(λz), terminal half-life (t1/2 λz).;Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-t)] and from zero to infinity (AUC).;Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of concentration at Weeks 6 and 12 [AUC(0-6w) and AUC(0 12w)].;Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).;Description of pharmacodynamics in terms of total interleukin 6 (IL-6) and free IL-6 (exploratory) in plasma and high sensitive C-reactive protein (hs-CRP) pre and post MEDI5117 or placebo administration and their corresponding change from baseline.;Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood.",D4430C00001,Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients,"A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)",;;,;;,Interventional,"Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science",Phase 1,2012-03-19,2012-05-20,39,Terminated,AstraZeneca,NULL,united states;germany;united kingdom;united states;germany;united kingdom,Biological: MEDI5117;Biological: MEDI5117 Placebo,"
Inclusion Criteria:
- Active Rheumatoid Arthritis (RA) for 6 months or more.
- Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
- Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg,
inclusive.
- Males, unless surgically sterile, must use 2 effective methods of birth control from
Day 1 through follow-up.
Exclusion Criteria:
- History or presence of any clinically significant disease or disorder which has not
been stable over the previous 3 months.
- History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
- Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica,
giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
- Current, chronic pain disorders including fibromyalgia and chronic regional pain
syndromes or chronic fatigue syndromes.
- Intramuscular steroid injection or intraarticular steroid injection within 1 month of
enrollment.
",NULL,"Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables.","Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(?z), terminal half-life (t1/2 ?z).;Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-t)] and from zero to infinity (AUC).;Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of concentration at Weeks 6 and 12 [AUC(0-6w) and AUC(0 12w)].;Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).;Description of pharmacodynamics in terms of total interleukin 6 (IL-6) and free IL-6 (exploratory) in plasma and high sensitive C-reactive protein (hs-CRP) pre and post MEDI5117 or placebo administration and their corresponding change from baseline.;Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-05-31,2012-03-19,2012-03-19,39,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,2015-02-19,TRUE,FALSE,FALSE
11844,NCT01204190,NA,NA,NCT: 2010-09-16 ICTRP: NA DRKS: NA,1,1,NA,1,1,a,How is ovulation measured? Criteria more specific in paper.,2,1,NA,4,1,no AM,4,1,no AM,NCT: Actual 173 ICTRP: NA DRKS: NA,171,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.3109/01443615.2015.1041882,2015-09-13,2010-09-17,NA,2010-09-30,2011-08-31,Interventional,"Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.","Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles",Completed,Phase 2,173,Actual,Bayer,Hoogland score to evaluate the inhibition of ovulation,"Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone;Follicle size measured by transvaginal ultrasound examination;Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)",2010-021255-81;15264,"Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.","Multicenter, Open-label, Randomized Study to Evaluate Inhibition of Ovulation During Treatment With Three Transdermal Patch Formulations Containing 0.55 mg Ethinylestradiol (EE) and 2.10 mg Gestodene (GSD) or 0.35 mg EE and 0.67 mg GSD or 0.275 mg EE and 1.05 mg GSD in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles",,,Interventional,"Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention",Phase 2,2010-09-16,2010-09-20,173,Completed,Bayer,NULL,germany;netherlands;germany;netherlands,Drug: Gestodene/EE Patch (BAY86-5016);Drug: Gestodene/EE Patch (BAY86-5016);Drug: Gestodene/EE Patch (BAY86-5016),"
Inclusion Criteria:
- Healthy female volunteers
- age 18 - 35 years (smoker not older than 30 years, inclusive)
- ovulatory pre-treatment cycle
Exclusion Criteria:
- Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g.
history of venous or arterial thromboembolic disease)
- Regular intake of medication other than Oral Contraception
- Clinically relevant findings (blood pressure, physical and gynecological examination,
laboratory examination)
",NULL,Hoogland score to evaluate the inhibition of ovulation,"Blood level time course of gonadotropins i.e. follicle stimulating hormone (FSH) and luteinizing formone (LH) as well as steroid hormones estradiol and progesterone;Follicle size measured by transvaginal ultrasound examination;Pharmacokinetics of ethinyl estradiol (EE), gestodene (GSD) and sex hormone binding globuline (SHBG)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-09-30,2010-09-16,2010-09-16,173,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2010,2014-11-03,TRUE,FALSE,TRUE
12037,NCT01174446,NA,NCT01174446,NCT: 2010-08-02 ICTRP: 2010-08-02 DRKS: NA,1,1,NA,2,1,NA,NA,1,1,No dosages,5,1,NA,5,1,NA,NCT: Actual 86 ICTRP: 86 DRKS: NA,86,1,1,NA,NA,NA,"Double (Participant, Investigator)","Unclear (""blinded PK crossover"")",no_info,1,NA,ganzer Artikel,https://doi.org/10.1111/hae.12228,2013-07-09,2010-08-03,NA,2010-07-29,2012-05-03,Interventional,"Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients","Recombinant Factor IX (BAX 326): A Phase 1/3, Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety and Immunogenicity in Previously Treated Patients With Severe or Moderately Severe Hemophilia B",Completed,Phase 3,86,Actual,Shire,Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose,"Consumption of BAX326 Per Event Per Participant;Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose);Study Parts 1 and 3: Mean Residence Time (MRT);Study Parts 1 and 3: Clearance (CL);Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax);Incremental Recovery (IR) at 30 Minutes Over Time;Change in Incremental Recovery (IR) at 30 Minutes Over Time;Study Parts 1 and 3: Half Life (T 1/2);Study Parts 1 and 3: Volume of Distribution at Steady State (Vss);Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326;Bleeding Episodes Treated With 1, 2 or ≥3 Infusions of BAX326 by Bleeding Site and Cause;Hemostatic Efficacy at Resolution of All Bleeding Episodes (BEs) Treated With BAX326 by Bleeding Site and Cause;Total Weight-adjusted Dose Per Bleeding Episode (BEs) of All BEs Treated With BAX326 by Bleeding Site and Cause;Consumption of BAX326 Per Participant: Median Number of Infusions Per Month;Consumption of BAX326 Per Participant: Median Weight-adjusted Consumption Per Month;Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX);Occurrence of Total Binding Antibodies of Indeterminate Specificity (Within Assay Variability);Occurrence of Treatment Related Total Binding Antibodies;Number of Participants Who Experienced Severe Allergic Reactions (e.g. Anaphylaxis);Number of Participants Who Experienced Thrombotic Events;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Clinical Chemistry;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Hematology;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Vital Signs;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Thrombogenic Markers;Number of Adverse Events (AEs) After BAX326 Treatment;Number of Participants With Adverse Events (AEs) After BAX326 Treatment;EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Total Index Scores;EuroQoL (Quality of Life)-5 Dimensions Visual Analogue Scale (EQ-5D VAS) Scores;General Pain Assessment Through a Visual Analog Scale (VAS);Short Form (36) Health Survey (SF-36): HRQoL 'Physical Component Score' (PCS);SF-36: HRQoL 'Mental Health' (MH);SF-36: HRQoL Physical Functioning' (PF);Health Resource Use - Emergency Room Visits;SF-36: HRQoL Role-Physical (RP);SF-36: HRQoL Role-Emotional;SF-36: HRQoL Bodily Pain;SF-36: HRQoL Mental Health;SF-36: HRQoL Vitality;SF-36: HRQoL Social Functioning;SF-36: HRQoL General Health;Pediatric Quality of Life Questionnaire (PedsQL) Physical Health Summary Score (Ages 12-16);Pediatric Quality of Life Questionnaire (PedsQL) Psychosocial Health Summary Score (Ages 12-16);Pediatric Quality of Life Questionnaire (PedsQL) Total Score (Ages 12-16);Health-Related Quality of Life (HRQoL) Disease-specific: Haem-A-QoL;Health-Related Quality of Life (HRQoL) Disease-specific: Haemo-QoL - Participants On-Demand (Ages 12-16);Health Resource Use - Number of Hospitalizations;Health Resource Use - Total Days of Hospital Stay;Health Resource Use - Unscheduled Doctor's Office Visits;Health Resource Use - Days Lost From Work or School",2009-016720-31;250901,"Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients","Recombinant Factor IX (BAX 326): A Phase 1/3, Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety and Immunogenicity in Previously Treated Patients With Severe or Moderately Severe Hemophilia B",,,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2010-08-02,2010-07-29,86,Completed,Baxalta now part of Shire,NULL,argentina;brazil;bulgaria;chile;colombia;czechia;japan;poland;romania;russian federation;spain;sweden;ukraine;united kingdom;argentina;brazil;bulgaria;chile;colombia;czechia;japan;poland;romania;russian federation;spain;sweden;ukraine;united kingdom;czech republic;germany,Biological: BAX 326;Biological: BeneFIX,"
Main Inclusion Criteria:
- Participant is 12 to 65 years old at the time of screening
- Participant and/or legal representative has/have provided signed informed consent
- Participant has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level
1-2%) hemophilia B (based on the one stage activated partial thromboplastin time
(aPTT) assay), as tested at screening at the central laboratory
- Participant is previously treated with plasma-derived or recombinant FIX
concentrate(s) for a minimum of 150 exposure days (EDs) (based on the participant's
medical records); if a verifiable, documented history is unavailable, the participant
can be enrolled if s/he has 100-150 EDs to any FIX product that are not fully
documented and has participated in Study 050901 for at least 50 EDs to Immunine prior
to enrollment (not valid for US and Japan).
- Participant has no evidence of a history of FIX inhibitors
- If the participant is to receive prophylactic treatment, the participant is willing to
receive prophylactic treatment over a period of 6 months.
- If the participant is to receive on-demand treatment, the participant has =12
documented bleeding episodes requiring treatment within 12 months prior to enrollment
and is willing to receive on-demand treatment for the duration of this study.
Main Exclusion Criteria:
- The participant has a history of FIX inhibitors with a titer =0.6 Bethesda Units (BU)
(as determined by the Nijmegen modification of the Bethesda assay or the assay
employed in the respective local laboratory) at any time prior to screening
- The participant has a detectable FIX inhibitor at screening, with a titer =0.6 BU as
determined by the Nijmegen modification of the Bethesda assay in the central
laboratory
- The participant's weight is < 35 kg or > 120 kg
- The participant has a history of allergic reaction, eg, anaphylaxis, following
exposure to FIX concentrate(s)
- The participant has a known hypersensitivity to hamster proteins or recombinant furin
(rFurin)
- The participant has ongoing or recent evidence of a thrombotic disease, fibrinolysis
or disseminated intravascular coagulation (DIC)
",NULL,Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose,"Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-8/ Dose);Study Parts 1 and 3: Mean Residence Time (MRT);Study Parts 1 and 3: Clearance (CL);Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax);Incremental Recovery (IR) at 30 Minutes Over Time;Change in Incremental Recovery (IR) at 30 Minutes Over Time;Study Parts 1 and 3: Half Life (T 1/2);Study Parts 1 and 3: Volume of Distribution at Steady State (Vss);Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326;Bleeding Episodes Treated With 1, 2 or =3 Infusions of BAX326 by Bleeding Site and Cause;Hemostatic Efficacy at Resolution of All Bleeding Episodes (BEs) Treated With BAX326 by Bleeding Site and Cause;Total Weight-adjusted Dose Per Bleeding Episode (BEs) of All BEs Treated With BAX326 by Bleeding Site and Cause;Consumption of BAX326 Per Event Per Participant;Consumption of BAX326 Per Participant: Median Number of Infusions Per Month;Consumption of BAX326 Per Participant: Median Weight-adjusted Consumption Per Month;Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX);Occurrence of Total Binding Antibodies of Indeterminate Specificity (Within Assay Variability);Occurrence of Treatment Related Total Binding Antibodies;Number of Participants Who Experienced Severe Allergic Reactions (e.g. Anaphylaxis);Number of Participants Who Experienced Thrombotic Events;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Clinical Chemistry;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Hematology;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Vital Signs;Number of Participants With Clinically Significant Changes in Laboratory Parameters: Thrombogenic Markers;Number of Adverse Events (AEs) After BAX326 Treatment;Number of Participants With Adverse Events (AEs) After BAX326 Treatment;EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Total Index Scores;EuroQoL (Quality of Life)-5 Dimensions Visual Analogue Scale (EQ-5D VAS) Scores;General Pain Assessment Through a Visual Analog Scale (VAS);Short Form (36) Health Survey (SF-36): HRQoL 'Physical Component Score' (PCS);SF-36: HRQoL 'Mental Health' (MH);SF-36: HRQoL Physical Functioning' (PF);SF-36: HRQoL Role-Physical (RP);SF-36: HRQoL Role-Emotional;SF-36: HRQoL Bodily Pain;SF-36: HRQoL Mental Health;SF-36: HRQoL Vitality;SF-36: HRQoL Social Functioning;SF-36: HRQoL General Health;Pediatric Quality of Life Questionnaire (PedsQL) Physical Health Summary Score (Ages 12-16);Pediatric Quality of Life Questionnaire (PedsQL) Psychosocial Health Summary Score (Ages 12-16);Pediatric Quality of Life Questionnaire (PedsQL) Total Score (Ages 12-16);Health-Related Quality of Life (HRQoL) Disease-specific: Haem-A-QoL;Health-Related Quality of Life (HRQoL) Disease-specific: Haemo-QoL - Participants On-Demand (Ages 12-16);Health Resource Use - Number of Hospitalizations;Health Resource Use - Total Days of Hospital Stay;Health Resource Use - Emergency Room Visits;Health Resource Use - Unscheduled Doctor's Office Visits;Health Resource Use - Days Lost From Work or School",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-07-29,2010-08-02,2010-08-02,86,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2010,2019-05-20,TRUE,FALSE,TRUE
18256,NCT00142259,NA,NCT00142259,NCT: 2005-09-01 ICTRP: 2005-09-01 DRKS: NA,1,1,NA,1,NA,NA,How is dystonia diagnosed?,1,1,no details on stimulation,4,1,no AM,4,1,no AM,NCT: NA 40 ICTRP: 40 DRKS: NA,40,1,1,2,1,NA,Double,Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1056/nejmoa063618,2006-11-09,2005-09-02,NA,2002-10-31,2009-08-31,Interventional,Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia,"Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie",Unknown status,Phase 4,40,NA,German Parkinson Study Group (GPS),relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline,relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline,Grant: 01 GI 0201 / 01 GI 0401;15,Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia,"Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 4,2005-09-01,2002-10-20,40,"Active, not recruiting",German Parkinson Study Group (GPS),Medtronic;Competence Network on Parkinson's Disease,austria;germany;austria;germany,Device: Deep brain stimulation of the internal globus pallidus,"
Inclusion Criteria:
- diagnosis of idiopathic multifocal, segmental or generalised dystonia
- duration of disease > 5 years
- age between 14 and 75 years
- relevant disability in activities of daily living despite optimal drug treatment
- informed consent signed by the patient
- For adolescents between 14 and 18 years: an additional informed consent signed by a
legal guardian is necessary
Exclusion Criteria:
- Mattis-Score < 120
- BDI > 25
- previous stereotactic brain surgery
- severe brain atrophy
- increased bleeding risk
- immunosuppression and increased risk of infection
- relevant cerebrovascular disease
- psychiatric disorders, which might interfere with the cooperation in the study
- other contraindications for surgery
",NULL,relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline,relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-10-31,2005-09-01,2005-09-01,40,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,2006-12-05,TRUE,FALSE,FALSE
16486,NCT00420212,NA,NA,NCT: 2007-01-08 ICTRP: NA DRKS: NA,1,1,NA,2,1,a,"criteria more specific in paper: ""disease activity as evidenced by at least one clinically documented relapse within 12 months before randomization or a brain magnetic resonance imaging
(MRI) scan, obtained within 6 weeks before randomization, that showed at least one gadoliniumenhancing lesion.""",2,1,NA,5,1,NA,5,1,NA,NCT: Actual 1234 ICTRP: NA DRKS: NA,1234,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1056/nejmoa1114287,2012-09-20,2007-01-11,NA,2007-01-31,2011-02-28,Interventional,Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis,"A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis",Completed,Phase 3,1234,Actual,Biogen,Proportion of Subjects Relapsed,Number of New or Newly Enlarging T2 Hyperintense Lesions;Number of Gadolinium-enhancing T1-weighted Lesions;Number of Subjects With Gadolinium (Gd)-Enhancing Lesions;Annualized Relapse Rate;Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS),109MS301,Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis,"A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis",;;;,;;;,Interventional,,Phase 3,2007-01-08,2007-01-20,1234,Completed,Biogen,NULL,"united states;australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;virgin islands (u.s.);australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;united states;virgin islands (u.s.);belarus;bulgaria;kazakhstan;russian federation;sweden;turkey;united states;australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;virgin islands (u.s.);australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;united states;virgin islands (u.s.);belarus;bulgaria;kazakhstan;russian federation;sweden;turkey;united states;australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;virgin islands (u.s.);australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;united states;virgin islands (u.s.);belarus;bulgaria;kazakhstan;russian federation;sweden;turkey;united states;australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;virgin islands (u.s.);australia;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;greece;guatemala;india;israel;italy;macedonia, the former yugoslav republic of;mexico;moldova, republic of;netherlands;new zealand;poland;romania;serbia;slovakia;south africa;switzerland;ukraine;united kingdom;united states;virgin islands (u.s.);belarus;bulgaria;kazakhstan;russian federation;sweden;turkey",Drug: BG00012;Drug: Placebo;Drug: BG00012;Drug: Placebo;Drug: BG00012;Drug: Placebo;Drug: BG00012;Drug: Placebo,"
Key Inclusion Criteria:
- Unless otherwise specified, to be eligible to participate in this study, candidates
must meet the following eligibility criteria at the time of the randomization:
- Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have relapsing-remitting disease course.
Key Exclusion Criteria:
- Unless otherwise specified, candidates will be excluded from study entry if any of the
following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,
gastrointestinal disease.
- Pregnant or nursing women.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
;
Key Inclusion Criteria:
- Unless otherwise specified, to be eligible to participate in this study, candidates
must meet the following eligibility criteria at the time of the randomization:
- Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have relapsing-remitting disease course.
Key Exclusion Criteria:
- Unless otherwise specified, candidates will be excluded from study entry if any of the
following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,
gastrointestinal disease.
- Pregnant or nursing women.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
;
Key Inclusion Criteria:
- Unless otherwise specified, to be eligible to participate in this study, candidates
must meet the following eligibility criteria at the time of the randomization:
- Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have relapsing-remitting disease course.
Key Exclusion Criteria:
- Unless otherwise specified, candidates will be excluded from study entry if any of the
following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,
gastrointestinal disease.
- Pregnant or nursing women.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
;
Key Inclusion Criteria:
- Unless otherwise specified, to be eligible to participate in this study, candidates
must meet the following eligibility criteria at the time of the randomization:
- Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have relapsing-remitting disease course.
Key Exclusion Criteria:
- Unless otherwise specified, candidates will be excluded from study entry if any of the
following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary,
gastrointestinal disease.
- Pregnant or nursing women.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
",NULL,Proportion of Subjects Relapsed;Proportion of Subjects Relapsed,Number of New or Newly Enlarging T2 Hyperintense Lesions;Number of Gadolinium-enhancing T1-weighted Lesions;Number of Subjects With Gadolinium (Gd)-Enhancing Lesions;Annualized Relapse Rate;Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-01-31,2007-01-08,2007-01-08,1234,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,2015-01-13,TRUE,FALSE,TRUE
18188,NCT00151112,NA,NCT00151112,NCT: 2005-09-07 ICTRP: 2005-09-07 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",4,NA,no measure,NCT: Actual 100 ICTRP: 100 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,Outcome missing,kein Artikel,NA,NA,2005-09-08,NA,2005-09-30,2008-08-31,Interventional,Comparison of Two Different Procedures for Plexus Anesthesia,Comparison of Two Different Procedures for Plexus Anesthesia: Standard Position Versus Combination of Lateral Position and 20° Trendelenburg Position,Completed,N/A,100,Actual,University Hospital Muenster,Extent of anesthesia;Efficacy of anesthesia,Rate of failure,01-Anast-05,Comparison of Two Different Procedures for Plexus Anesthesia,Comparison of Two Different Procedures for Plexus Anesthesia: Standard Position Versus Combination of Lateral Position and 20° Trendelenburg Position,,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention",N/A,2005-09-07,2005-09-20,100,Completed,University Hospital Muenster,NULL,germany,Procedure: Positioning and plexus anesthesia,
Inclusion Criteria:
- Single shot axillary block
Exclusion Criteria:
- Lateral position not possible
,NULL,Extent of anesthesia;Efficacy of anesthesia,Rate of failure,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-09-30,2005-09-07,2005-09-07,100,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2005,2008-09-10,TRUE,FALSE,FALSE
18846,NCT00050934,NA,NCT00050934,NCT: 2002-12-30 ICTRP: 2002-12-30 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no AM,5,NA,NA,NCT: Actual 132 ICTRP: 132 DRKS: NA,NA,1,1,NA,NA,Information on blinding only in title,NA,NA,NA,1,"""as therapy"" deemed sufficient as outcome",kein Artikel,NA,NA,2003-01-01,NA,2002-06-30,2004-06-30,Interventional,Pediatric Epilepsy Study,"A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.",Completed,Phase 3,132,Actual,Novartis,change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline),"% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).",CTRI476E 2340,Pediatric Epilepsy Study,"A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.",,,Interventional,"Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment",Phase 3,2002-12-30,2002-06-20,132,Completed,Novartis Pharmaceuticals,NULL,united states;brazil;germany;mexico;united states;brazil;germany;mexico,Drug: oxcarbazepine,"
INCLUSION CRITERIA: To enter this study, patients must:
- Have a diagnosis of partial seizures
- Be willing to be hospitalized
- Weigh a minimum of 6.6 pounds
- Be taking a stable dose of one to two concomitant anti-epileptic medications
- Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or
progressive neurological disease
- Have normal laboratory results
EXCLUSION CRITERIA: To enter this study, a patient must not have or be:
- Seizures caused by metabolic disturbance, toxic exposure, or active infection
- A primary diagnosis of generalized epilepsy (exception - secondarily generalized
seizures)
- A history of status epilepticus within 30 days
- Seizures not related to epilepsy
- Frequent use of additional anti-epileptic medications to treat increases in seizures
(for example: rectal diazepam)
- Taking felbamate within 6 months
- Serum sodium levels <135 mEq/L
- Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder
requiring treatment/therapy
- A history of chronic infection (e.g., hepatitis or HIV)
- Significant electrocardiogram (ECG) abnormalities
- A nursing mother taking anti-convulsant drugs
- Previously demonstrated sensitivity/allergic reaction to Trileptal or related
compounds
- Used experimental medication within 30 days of entering this study
",NULL,change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline),"% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-06-30,2002-12-30,2002-12-30,132,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,2011-11-22,TRUE,FALSE,FALSE
18029,NCT00171873,NA,NCT00171873,NCT: 2005-09-13 ICTRP: 2005-09-13 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,"intervals given, no time frame",4,1,no measure (definition of progression),5,0,Follow-up after 6 instead of 3 months,NCT: Actual 85 ICTRP: 85 DRKS: NA,85,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Double,worse,1,NA,ganzer Artikel,https://doi.org/10.1200/jco.2009.22.8510,2009-08-24,2005-09-15,NA,2001-09-30,2013-12-31,Interventional,Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut,Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut,Completed,Phase 3,85,Actual,Philipps University Marburg Medical Center,Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI),Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals;Biochemical Response at 3 Month Intervals;Symptom Control at 3 Month Intervals;Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study;Survival,CSMS995ADE05,Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut,Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut,,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2005-09-13,2001-09-20,85,Completed,Carmen Schade-Brittinger,NULL,germany,Drug: Octreotide LAR (Long-acting release);Drug: Placebo,"
Inclusion Criteria:
- Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable
or metastasized well-differentiated neuroendocrine tumor of the midgut
- curative surgery impossible
- two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic
Resonance Imaging (MRI)
- Age = 18
- Karnofsky-index > 60
- written informed consent
- proliferation index for Ki67
Exclusion Criteria:
- hypersensitivity to octreotide
- poorly differentiated or small cell neuroendocrine tumors
- primary tumor outside of the midgut
- prior treatment with somatostatin-analogue > 4 weeks
- prior treatment with alpha-interferon, chemotherapy, or chemoembolisation
- participation in any other clinical trial
- pregnancy or lactation
- no secondary malignancy in anamnesis; with the exception of patients without any
manifestation of the secondary malignancy (without relapse) after curative therapy
within the last five years
- severe decompensated organ malfunction (heart-, liver- insufficiency)
Other protocol-defined exclusion criteria may apply.
",NULL,Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI),Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals;Biochemical Response at 3 Month Intervals;Symptom Control at 3 Month Intervals;Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study;Survival,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-09-30,2005-09-13,2005-09-13,85,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2020-03-16,TRUE,FALSE,FALSE
15957,NCT00501631,NA,NCT00501631,NCT: 2007-07-12 ICTRP: 2007-07-12 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,no treatment duration,5,NA,NA,5,NA,NA,NCT: Actual 300 ICTRP: 300 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-07-16,NA,2007-07-31,2011-03-31,Interventional,ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence,Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence,Completed,Phase 3,300,Actual,"Alkermes, Inc.",Cumulative Percentage of Participants by Heavy Drinking Rate,Longer-term Safety of VIVITROL,ALK21-014,ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence,Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence,;;;,;;;,Interventional,,Phase 3,2007-07-12,2007-07-20,300,Completed,"Alkermes, Inc.",NULL,austria;germany;austria;germany;austria;germany;austria;germany,Drug: VIVITROL 380 mg;Drug: Placebo for VIVITROL 380 mg;Drug: VIVITROL 380 mg;Drug: Placebo for VIVITROL 380 mg;Drug: VIVITROL 380 mg;Drug: Placebo for VIVITROL 380 mg;Drug: VIVITROL 380 mg;Drug: Placebo for VIVITROL 380 mg,"
Primary Inclusion Criteria:
- Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
- Expected to complete inpatient treatment for alcohol dependence within 24 hours of
randomization
- Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to
first dose
- Negative urine toxicological screen for opioids on the day of randomization
- Women of childbearing potential must agree to use an approved method of contraception
for the study duration
Primary Exclusion Criteria:
- Pregnancy or lactation
- Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of
normal and/or esophageal variceal disease
- Current dependence (within the past year) to benzodiazepines, opioids or cocaine by
DSM-IV criteria
- Use of any opioids and/or methadone within 14 days prior to the screening visit, or
subjects likely to require opioid therapy during the study period
- Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
PLG
- Parole, probation, or pending legal proceedings having the potential for incarceration
during the study period
;
Primary Inclusion Criteria:
- Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
- Expected to complete inpatient treatment for alcohol dependence within 24 hours of
randomization
- Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to
first dose
- Negative urine toxicological screen for opioids on the day of randomization
- Women of childbearing potential must agree to use an approved method of contraception
for the study duration
Primary Exclusion Criteria:
- Pregnancy or lactation
- Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of
normal and/or esophageal variceal disease
- Current dependence (within the past year) to benzodiazepines, opioids or cocaine by
DSM-IV criteria
- Use of any opioids and/or methadone within 14 days prior to the screening visit, or
subjects likely to require opioid therapy during the study period
- Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
PLG
- Parole, probation, or pending legal proceedings having the potential for incarceration
during the study period
;
Primary Inclusion Criteria:
- Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
- Expected to complete inpatient treatment for alcohol dependence within 24 hours of
randomization
- Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to
first dose
- Negative urine toxicological screen for opioids on the day of randomization
- Women of childbearing potential must agree to use an approved method of contraception
for the study duration
Primary Exclusion Criteria:
- Pregnancy or lactation
- Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of
normal and/or esophageal variceal disease
- Current dependence (within the past year) to benzodiazepines, opioids or cocaine by
DSM-IV criteria
- Use of any opioids and/or methadone within 14 days prior to the screening visit, or
subjects likely to require opioid therapy during the study period
- Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
PLG
- Parole, probation, or pending legal proceedings having the potential for incarceration
during the study period
;
Primary Inclusion Criteria:
- Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
- Expected to complete inpatient treatment for alcohol dependence within 24 hours of
randomization
- Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to
first dose
- Negative urine toxicological screen for opioids on the day of randomization
- Women of childbearing potential must agree to use an approved method of contraception
for the study duration
Primary Exclusion Criteria:
- Pregnancy or lactation
- Evidence of hepatic failure including: ascites, bilirubin >10% above upper limit of
normal and/or esophageal variceal disease
- Current dependence (within the past year) to benzodiazepines, opioids or cocaine by
DSM-IV criteria
- Use of any opioids and/or methadone within 14 days prior to the screening visit, or
subjects likely to require opioid therapy during the study period
- Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
- Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or
PLG
- Parole, probation, or pending legal proceedings having the potential for incarceration
during the study period
",NULL,Cumulative Percentage of Participants by Heavy Drinking Rate;Cumulative Percentage of Participants by Heavy Drinking Rate,Longer-term Safety of VIVITROL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-07-31,2007-07-12,2007-07-12,300,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,2011-09-20,TRUE,FALSE,TRUE
12164,NCT01151072,NA,NCT01151072,NCT: 2010-06-24 ICTRP: 2010-06-24 DRKS: NA,1,NA,NA,2,NA,NA,Trial on healthy subjects,1,NA,No dosage (probably dependent on individual),5,NA,NA,5,NA,NA,NCT: Actual 20 ICTRP: 20 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2010-06-25,NA,2010-06-30,2010-10-31,Interventional,A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects,A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects,Completed,Phase 1,20,Actual,Novo Nordisk A/S,Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration),Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration);Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration);Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration);Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration),2009-017217-30;U1111-1113-6783;NN1250-1992,A Trial Comparing the Effect of NN1250 After Different Routes of Injection in Healthy Subjects,A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties of NN1250 After Different Routes of Administration in Healthy Subjects,;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1,2010-06-24,2010-06-20,20,Completed,Novo Nordisk A/S,NULL,germany;germany;germany;germany;germany,Drug: insulin degludec;Drug: insulin degludec;Drug: insulin degludec;Drug: insulin degludec,"
Inclusion Criteria:
- Considered generally healthy upon completion of medical history, physical examination,
vital signs and ECG (electrocardiogram), as judged by the Investigator
- Body mass index 18.0-27.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
;
Inclusion Criteria:
- Considered generally healthy upon completion of medical history, physical examination,
vital signs and ECG (electrocardiogram), as judged by the Investigator
- Body mass index 18.0-27.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
;
Inclusion Criteria:
- Considered generally healthy upon completion of medical history, physical examination,
vital signs and ECG (electrocardiogram), as judged by the Investigator
- Body mass index 18.0-27.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
;
Inclusion Criteria:
- Considered generally healthy upon completion of medical history, physical examination,
vital signs and ECG (electrocardiogram), as judged by the Investigator
- Body mass index 18.0-27.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
",NULL,Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration);Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration);Area under the serum Insulin Degludec concentration-time curve (only for subcutaneous administration),Area under the serum Insulin Degludec concentration-time curve (only for intramuscular administration);Area under the serum Insulin Degludec concentration-time curve (only for intravenous administration);Maximum observed serum Insulin Degludec concentration after single-dose (only for subcutaneous and intramuscular administration);Back-extrapolated initial serum Insulin Degludec concentration after single-dose (only for intravenous administration),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-06-30,2010-06-24,2010-06-24,20,Interventional,FALSE,FALSE,TRUE,NA,FALSE,TRUE,FALSE,FALSE,NA,FALSE,2010,2017-01-19,TRUE,FALSE,FALSE
16120,NCT00473772,NA,NCT00473772,NCT: 2007-05-14 ICTRP: 2007-05-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no metric",2,NA,"no AM, no metric, no measure",NCT: Actual 643 ICTRP: 643 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,No outcome,kein Artikel,NA,NA,2007-05-15,NA,2007-07-31,2011-01-31,Interventional,DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease,Paclitaxel-Eluting PTCA-Balloon in Combination With the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease,Completed,Phase 1/Phase 2,643,Actual,"University Hospital, Saarland",late lumen loss,MACE;MACE;MACE;Binary restenosis rate,BBM-VS-54,DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease,Paclitaxel-Eluting PTCA-Balloon in Combination With the CoroflexTM Blue Stent vs the Sirolimus Coated CypherTM Stent in the Treatment of Advanced Coronary Artery Disease,;,;,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment",Phase 1/Phase 2,2007-05-14,2007-07-20,643,Completed,"University Hospital, Saarland","B.Braun Vascular Systems, Berlin, Germany",belgium;czech republic;france;germany;netherlands;spain;sweden;united kingdom;belgium;czech republic;france;germany;netherlands;spain;sweden;united kingdom,Device: DEBlue stent vs. Cypher stent,"
Inclusion Criteria:
- Patients with stable or unstable angina or documented ischemia due to a significant
lesion in a native coronary artery
- Patients eligible for coronary revascularization by means of PCI
- Intention to treat one lesion with one stent
- Patients suitable for coronary revascularization of any sort (balloon angioplasty,
device-assisted balloon-angioplasty, or coronary artery bypass grafting)
- Patients must be = 18 years of age
- Women of childbearing potential may not be pregnant nor have the desire to becoming
pregnant during the first year following the study procedure. Hence, patients will be
advised to use an adequate birth control method up to and including 9 months
follow-up
- Patients who are mentally and linguistically able to understand the aim of the study
and to show sufficient compliance in following the study protocol
- Patients must agree to undergo the 9 months angiographic follow-up
- Patients must agree to undergo the 1 and 3 year clinical follow-up
- Patient is able to verbally acknowledge an understanding of the associated risks,
benefits, and treatment alternatives to therapeutic options of this trial, e.g.
balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter in
combination with the Coroflex BlueTM stent or the Sirolimus-eluting CypherTM stent.
The patients, by providing informed consent, agree to these risks and benefits as
stated in the patient informed consent document.
- Significant stenoses in native coronary arteries with nominal stent diameters between
= 2.5 mm and = 3.5 mm and < 24 mm in length
Exclusion Criteria:
- Unprotected left main
- In stent restenosis
- Indication for more than one lesion to treat, even as staged procedure
- Intended bifurcational stenting
- Patients requiring chronic anticoagulation
- SVG and AG
- Acute MI (STEMI, NSTEMI)
- Cardiogenic shock
- Chronic total occlusions
- Pregnancy
- Patients with stand alone balloon angioplasty, or stent deployment 6 months prior to
enrolment into this study
",NULL,late lumen loss,MACE;MACE;MACE;Binary restenosis rate,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-07-31,2007-05-14,2007-05-14,643,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2007,2014-05-05,TRUE,FALSE,FALSE
27202,NCT00168454,DRKS00004022,DRKS00004022,NCT: NA ICTRP: 2012-07-03 DRKS: 2012-07-03,1,1,NA,1,1,a,NA,2,1,NA,5,1,NA,5,0,Additional scales: KHQ and SF-36. MCC (that is outcome 3) not assessed. Different time frames for number of micturitions.,NCT: NA ICTRP: 313 DRKS: [---]* 313,313,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Double,worse,0,No outcome and intervention,ganzer Artikel,https://doi.org/10.1016/j.eururo.2012.03.005,2012-03-05,2005-09-15,NA,2005-07-31,2008-06-30,Interventional,A Research Study for Patients With Overactive Bladder,NA,Completed,Phase 2,313,Actual,Allergan,Change in Number of Urinary Urge Incontinence Episodes,Change in Number of Micturitions;Change in Number of Nocturia Episodes;Maximum Cystometric Capacity (MCC) by Urodynamic Measurements;Incontinence Quality of Life Instrument (I-QOL),191622-077,A Research Study for Patients With Overactive Bladder,,;;;,;;;,Interventional,,Phase 2,2005-09-12,2005-07-20,313,Completed,Allergan,NULL,united states;belgium;canada;germany;poland;united kingdom;belgium;canada;germany;poland;united kingdom;united states;united states;belgium;canada;germany;poland;united kingdom;belgium;canada;germany;poland;united kingdom;united states;united states;belgium;canada;germany;poland;united kingdom;belgium;canada;germany;poland;united kingdom;united states;united states;belgium;canada;germany;poland;united kingdom;belgium;canada;germany;poland;united kingdom;united states,Biological: botulinum toxin Type A;Drug: Placebo;Biological: botulinum toxin Type A;Drug: Placebo;Biological: botulinum toxin Type A;Drug: Placebo;Biological: botulinum toxin Type A;Drug: Placebo,
Inclusion Criteria:
- Must be between 18-85 years old
- Must have been diagnosed by his/her doctor with overactive bladder at least 6 months
ago
- Must weigh at least 50 kg (110 lbs)
- Must be willing and able to record information regarding bladder function into a diary
(provided)
- Must be willing and able to complete the entire course of the study
Exclusion Criteria:
- Cannot currently be catheterizing as a way to control incontinence
- Must not have used botulinum toxin type A or any other botulinum toxin previously for
any condition
;
Inclusion Criteria:
- Must be between 18-85 years old
- Must have been diagnosed by his/her doctor with overactive bladder at least 6 months
ago
- Must weigh at least 50 kg (110 lbs)
- Must be willing and able to record information regarding bladder function into a diary
(provided)
- Must be willing and able to complete the entire course of the study
Exclusion Criteria:
- Cannot currently be catheterizing as a way to control incontinence
- Must not have used botulinum toxin type A or any other botulinum toxin previously for
any condition
;
Inclusion Criteria:
- Must be between 18-85 years old
- Must have been diagnosed by his/her doctor with overactive bladder at least 6 months
ago
- Must weigh at least 50 kg (110 lbs)
- Must be willing and able to record information regarding bladder function into a diary
(provided)
- Must be willing and able to complete the entire course of the study
Exclusion Criteria:
- Cannot currently be catheterizing as a way to control incontinence
- Must not have used botulinum toxin type A or any other botulinum toxin previously for
any condition
;
Inclusion Criteria:
- Must be between 18-85 years old
- Must have been diagnosed by his/her doctor with overactive bladder at least 6 months
ago
- Must weigh at least 50 kg (110 lbs)
- Must be willing and able to record information regarding bladder function into a diary
(provided)
- Must be willing and able to complete the entire course of the study
Exclusion Criteria:
- Cannot currently be catheterizing as a way to control incontinence
- Must not have used botulinum toxin type A or any other botulinum toxin previously for
any condition
,NULL,Change in Number of Urinary Urge Incontinence Episodes;Change in Number of Urinary Urge Incontinence Episodes,Change in Number of Micturitions;Change in Number of Nocturia Episodes;Maximum Cystometric Capacity (MCC) by Urodynamic Measurements;Incontinence Quality of Life Instrument (I-QOL),NCT00168454; 191622-077,2012-07-03,no,Overactive Bladder; Urinary Incontinence; Other specified disorders of bladder; Unspecified urinary incontinence,Arm 1 Biological: botulinum toxin Type A; Arm 2 Drug: Placebo,Interventional,Randomized controlled trial,Blinded,Placebo,Parallel,II,"- Change in Number of Urinary Urge Incontinence Episodes; time frame: Baseline, Week 2, Week 6, Week 12; Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate.
","- Change in Number of Micturitions; time frame: Baseline, Week 2, Week 6, Week 12; Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet.
- Change in Number of Nocturia Episodes; time frame: Baseline, Week 12; Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep.
- Maximum Cystometric Capacity (MCC) by Urodynamic Measurements; time frame: Baseline, Week 12; Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters
- Incontinence Quality of Life Instrument (I-QOL); time frame: Baseline, Week 2, Week 6, Week 12; Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented.
",United States; Belgium; Canada; Germany; Poland; United Kingdom,[---]* Berlin,2005-07-31,NA,313,2008-06-01,- Must be between 18-85 years old
- Must have been diagnosed by his/her doctor with overactive bladder at least 6 months
ago
- Must weigh at least 50 kg (110 lbs)
- Must be willing and able to record information regarding bladder function into a
diary (provided)
- Must be willing and able to complete the entire course of the study
,- Cannot currently be catheterizing as a way to control incontinence
- Must not have used botulinum toxin type A or any other botulinum toxin previously for
any condition
,A Research Study for Patients With Overactive Bladder,"Recruiting complete, follow-up complete",Allergan; Allergan; Allergan,[---]*; [---]*; [---]*,Arm 1 Biological: botulinum toxin Type A; Arm 2 Drug: Placebo,2005-07-31,2005-09-12,2005-09-12,313,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2005,2013-10-11,TRUE,TRUE,TRUE
17537,NCT00256776,NA,NCT00256776,NCT: 2005-11-21 ICTRP: 2005-11-21 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,Details taken from study description section,3,NA,"no AM, no measure",4,NA,no measure,NCT: Actual 269 ICTRP: 269 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,Review,https://doi.org/10.1002/hon.2706,NA,2005-11-22,NA,2005-07-31,2015-12-31,Interventional,MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation,A Randomized Controlled Study of Velcade (Bortezomib) Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation,Terminated,Phase 3,269,Actual,European Group for Blood and Marrow Transplantation,"Time to progression, the interval between the date of randomization and date of disease progression (death without progression is a competing risk)","Overall survival (interval between date of randomization and death from any cause;Response rate (proportion of subjects who achieve complete, partial, or minimal response)",EBMT-CLWP: 42206611;EudraCT: 2005-001628-35,MMVAR - Velcade: Study of Velcade for the Treatment of Myeloma Patients After Autologous Transplantation,A Randomized Controlled Study of Velcade (Bortezomib) Plus Thalidomide Plus Dexamethasone Compared to Thalidomide Plus Dexamethasone for the Treatment of Myeloma Patients Progressing or Relapsing After Autologous Transplantation,,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 3,2005-11-21,2005-07-20,269,"Active, not recruiting",European Group for Blood and Marrow Transplantation,"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.;Celgene Corporation",austria;belgium;czech republic;france;germany;hungary;israel;italy;switzerland;united kingdom;austria;belgium;czech republic;france;germany;hungary;israel;italy;switzerland;united kingdom,Drug: Velcade (Bortezomib);Drug: Thalidomide;Drug: Dexamethasone,"
Inclusion Criteria:
- Male or female =18 years-of-age
- Multiple myeloma with evaluable disease
- Relapsing or having a progressive disease
- Karnofsky performance status > 50 %
- Life expectancy of at least 3 months
- Female of child-bearing potential must have a method of birth control and a negative
serum or urine beta--human chorionic gonadotropin (ß-HCG) pregnancy test at screening
and all through the study
- Male must use contraception
- Voluntary written informed consent
Exclusion Criteria:
- Non-secretory multiple myeloma
- Platelet count < 40,000 X 10^9/L
- Absolute neutrophil count <1.0 X 10^9/L
- Creatinine clearance <30 mL/minute
- Peripheral neuropathy >= Grade 2
- Seropositive for HIV, or active hepatitis A, B or C infection
- Pregnant or breastfeeding female
- Patient has hypersensitivity to bortezomib, boron or mannitol
- Other investigational drugs
- Serious medical or psychiatric illness
- Previous or concurrent malignancies at other sites
- Poorly controlled hypertension, uncontrolled or severe cardiovascular disease or
uncontrolled diabetes mellitus
",NULL,"Time to progression, the interval between the date of randomization and date of disease progression (death without progression is a competing risk)","Overall survival (interval between date of randomization and death from any cause;Response rate (proportion of subjects who achieve complete, partial, or minimal response)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-07-31,2005-11-21,2005-11-21,269,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2005,2020-12-21,TRUE,FALSE,FALSE
18045,NCT00171067,NA,NCT00171067,NCT: 2005-09-10 ICTRP: 2005-09-10 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,4,1,"no AM; Can UACR be regarded the same as ""albumin exretion""?",3,0,"Registration: no AM, no measure (definition of blood test); Paper: Endpoint 2 of 3 not assessed. Unclear to the rater whether the other endpoints were assessed.",NCT: Actual 134 ICTRP: 134 DRKS: NA,NA,1,1,2,1,NA,Double,Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1097/hjh.0b013e32830508aa,2008-03-20,2005-09-15,NA,2004-07-31,2007-05-31,Interventional,VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria,A Study to Evaluate the Effectiveness of Valsartan 320 mg in Combination With Lisinopril 20 mg Versus Monotherapy With Lisinopril 40 mg or Valsartan 320 mg in Hypertensive Patients With Microalbuminuria on the Reduction of Urinary Albumin Creatinine Ratio,Completed,Phase 3,134,Actual,Novartis,Change from baseline in urinary albumin excretion after 30 weeks,Change from baseline in blood test for kidney function after 30 weeks;Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg;Change from baseline in circulating marker of inflammation after 30 weeks,CVAL489ADE20,VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria,A Study to Evaluate the Effectiveness of Valsartan 320 mg in Combination With Lisinopril 20 mg Versus Monotherapy With Lisinopril 40 mg or Valsartan 320 mg in Hypertensive Patients With Microalbuminuria on the Reduction of Urinary Albumin Creatinine Ratio,;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double. ,Phase 3,2005-09-10,2004-07-20,134,Completed,Novartis,NULL,germany;switzerland;germany;switzerland;germany;switzerland;germany;switzerland;germany;switzerland;germany;switzerland;germany;switzerland;germany;switzerland;germany;switzerland;germany;switzerland,Drug: valsartan;Drug: lisinopril;Drug: valsartan;Drug: lisinopril;Drug: valsartan;Drug: lisinopril;Drug: valsartan;Drug: lisinopril,"
Inclusion Criteria:
- Patients with mild to moderate hypertension with a mean sitting diastolic blood
pressure (MSDBP) > 85 and < 110 mmHg for non-treated patients. Previously treated
patients with MSDBP < 110 mmHg. Treated is defined as having taken medication until <
2 days prior to Visit 1
- Positive urine spot test with Micral dipstick (detection of urinary albumin
concentration of at least 50 mg/l) at Visit 1 (day -21).
- Confirmation of MAU of at least 2 out of 3 measurements determined in the first
morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day
-7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) > 2.5
mg/mmol and < 25.0 mg/mmol and for female patients as UACR > 3.5 mg/mmol and < 35.0
mg/mmol at both visits.
Exclusion Criteria:
- Evidence of renal impairment as determined by any one of the following:
- serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault
formula [Cockroft and Gault, 1976] and/or
- serum creatinine > 1.25 x ULN at Visit 1,
- a history of dialysis, or
- a history of nephrotic syndrome.
- Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
- Any medical condition which might significantly alter the urinary excretion of albumin
Other protocol-defined exclusion criteria may apply.
;
Inclusion Criteria:
- Patients with mild to moderate hypertension with a mean sitting diastolic blood
pressure (MSDBP) > 85 and < 110 mmHg for non-treated patients. Previously treated
patients with MSDBP < 110 mmHg. Treated is defined as having taken medication until <
2 days prior to Visit 1
- Positive urine spot test with Micral dipstick (detection of urinary albumin
concentration of at least 50 mg/l) at Visit 1 (day -21).
- Confirmation of MAU of at least 2 out of 3 measurements determined in the first
morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day
-7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) > 2.5
mg/mmol and < 25.0 mg/mmol and for female patients as UACR > 3.5 mg/mmol and < 35.0
mg/mmol at both visits.
Exclusion Criteria:
- Evidence of renal impairment as determined by any one of the following:
- serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault
formula [Cockroft and Gault, 1976] and/or
- serum creatinine > 1.25 x ULN at Visit 1,
- a history of dialysis, or
- a history of nephrotic syndrome.
- Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
- Any medical condition which might significantly alter the urinary excretion of albumin
Other protocol-defined exclusion criteria may apply.
;
Inclusion Criteria:
- Patients with mild to moderate hypertension with a mean sitting diastolic blood
pressure (MSDBP) > 85 and < 110 mmHg for non-treated patients. Previously treated
patients with MSDBP < 110 mmHg. Treated is defined as having taken medication until <
2 days prior to Visit 1
- Positive urine spot test with Micral dipstick (detection of urinary albumin
concentration of at least 50 mg/l) at Visit 1 (day -21).
- Confirmation of MAU of at least 2 out of 3 measurements determined in the first
morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day
-7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) > 2.5
mg/mmol and < 25.0 mg/mmol and for female patients as UACR > 3.5 mg/mmol and < 35.0
mg/mmol at both visits.
Exclusion Criteria:
- Evidence of renal impairment as determined by any one of the following:
- serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault
formula [Cockroft and Gault, 1976] and/or
- serum creatinine > 1.25 x ULN at Visit 1,
- a history of dialysis, or
- a history of nephrotic syndrome.
- Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
- Any medical condition which might significantly alter the urinary excretion of albumin
Other protocol-defined exclusion criteria may apply.
;
Inclusion Criteria:
- Patients with mild to moderate hypertension with a mean sitting diastolic blood
pressure (MSDBP) > 85 and < 110 mmHg for non-treated patients. Previously treated
patients with MSDBP < 110 mmHg. Treated is defined as having taken medication until <
2 days prior to Visit 1
- Positive urine spot test with Micral dipstick (detection of urinary albumin
concentration of at least 50 mg/l) at Visit 1 (day -21).
- Confirmation of MAU of at least 2 out of 3 measurements determined in the first
morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day
-7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) > 2.5
mg/mmol and < 25.0 mg/mmol and for female patients as UACR > 3.5 mg/mmol and < 35.0
mg/mmol at both visits.
Exclusion Criteria:
- Evidence of renal impairment as determined by any one of the following:
- serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault
formula [Cockroft and Gault, 1976] and/or
- serum creatinine > 1.25 x ULN at Visit 1,
- a history of dialysis, or
- a history of nephrotic syndrome.
- Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
- Any medical condition which might significantly alter the urinary excretion of albumin
Other protocol-defined exclusion criteria may apply.
",NULL,Change from baseline in urinary albumin excretion after 30 weeks;Change from baseline in urinary albumin excretion after 30 weeks;Change from baseline in urinary albumin excretion after 30 weeks,Change from baseline in blood test for kidney function after 30 weeks;Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg;Change from baseline in circulating marker of inflammation after 30 weeks,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-07-31,2005-09-10,2005-09-10,134,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2004,2017-05-15,TRUE,FALSE,FALSE
16095,NCT00478569,NA,NCT00478569,NCT: 2007-05-23 ICTRP: 2007-05-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,Observational trial,5,NA,NA,4,NA,no AM,NCT: Actual 1179 ICTRP: 1179 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-05-25,NA,2007-04-30,2013-03-31,Observational,Adherence to PTH(1-84) Treatment (FP-002-IM),Adherence to PTH(1-84) Treatment in Europe. A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings,Completed,NA,1179,Actual,Takeda,Number of Participants Who Discontinued Before 6 Months of Treatment,"Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment;Duration of Treatment;Treatment Compliance by Visit",FP-002-IM,Adherence to PTH(1-84) Treatment (FP-002-IM),Adherence to PTH(1-84) Treatment in Europe. A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings,;;;,;;;,Observational,,N/A,2007-05-23,2007-04-20,1179,Completed,Takeda,NULL,denmark;germany;denmark;germany;denmark;germany;denmark;germany,Drug: Parathyroid Hormone (PTH) (1-84);Drug: Parathyroid Hormone (PTH) (1-84);Drug: Parathyroid Hormone (PTH) (1-84);Drug: Parathyroid Hormone (PTH) (1-84),
Inclusion Criteria:
- According to the current Summary of Product Characteristics (SmPC)
- PTH(1-84) treatment initiated within one month preceding enrolment
- The patient's written informed consent to direct access and data processing must be
obtained.
Exclusion Criteria:
- According to the current SmPC
- The patient cannot participate in a clinical trial with PTH (all other trials
allowed).
;
Inclusion Criteria:
- According to the current Summary of Product Characteristics (SmPC)
- PTH(1-84) treatment initiated within one month preceding enrolment
- The patient's written informed consent to direct access and data processing must be
obtained.
Exclusion Criteria:
- According to the current SmPC
- The patient cannot participate in a clinical trial with PTH (all other trials
allowed).
;
Inclusion Criteria:
- According to the current Summary of Product Characteristics (SmPC)
- PTH(1-84) treatment initiated within one month preceding enrolment
- The patient's written informed consent to direct access and data processing must be
obtained.
Exclusion Criteria:
- According to the current SmPC
- The patient cannot participate in a clinical trial with PTH (all other trials
allowed).
;
Inclusion Criteria:
- According to the current Summary of Product Characteristics (SmPC)
- PTH(1-84) treatment initiated within one month preceding enrolment
- The patient's written informed consent to direct access and data processing must be
obtained.
Exclusion Criteria:
- According to the current SmPC
- The patient cannot participate in a clinical trial with PTH (all other trials
allowed).
,NULL,Number of Participants Who Discontinued Before 6 Months of Treatment;Number of Participants Who Discontinued Before 6 Months of Treatment,"Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment;Duration of Treatment;Treatment Compliance by Visit",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-04-30,2007-05-23,2007-05-23,1179,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2007,2014-04-29,TRUE,FALSE,FALSE
7741,NCT01908322,NA,NCT01908322,NCT: 2013-07-23 ICTRP: 2013-07-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,Observational trial. Dosage at discretion of investigator.,5,NA,NA,4,NA,no AM,NCT: Actual 19 ICTRP: 19 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,"Outcome unclear (""for treatment"" in title, meaning ""distribution to treatment groups"")",kein Artikel,NA,NA,2013-07-25,NA,2013-08-31,2015-09-30,Observational,Investigating Patient Characteristics of Intermediate Stage Hepatocellular Carcinoma Patients Treated With Nexavar and Their Distribution to Different Treatment Groups as Well as Determining Effectiveness and Safety,SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma,Completed,NA,19,Actual,Bayer,"Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.;Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).","Safety variables will be summarized using descriptive statistics based on adverse events collection.;Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.;Further possible prognostic factors will be evaluated.;Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.;Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.;Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.;Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.;Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).",16628,Investigating Patient Characteristics of Intermediate Stage Hepatocellular Carcinoma Patients Treated With Nexavar and Their Distribution to Different Treatment Groups as Well as Determining Effectiveness and Safety,SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma,,,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2013-07-23,2013-08-20,19,Completed,Bayer,NULL,germany,"Drug: Sorafenib (Nexavar, BAY43-9006)","
Inclusion Criteria:
- Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma
(BCLC-B) for whom the decision has been taken by the investigator to prescribe
Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients
with large/multifocal HCC who do not have cancer related symptoms, macrovascular
invasion or extrahepatic spread).
Exclusion Criteria:
- Prior targeted therapy for hepatocellular carcinoma.
",NULL,"Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.;Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).","Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.;Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.;Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.;Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.;Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).;Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.;Further possible prognostic factors will be evaluated.;Safety variables will be summarized using descriptive statistics based on adverse events collection.",NCT01908322; 16628,2014-03-26,no,"Carcinoma, Hepatocellular; Malignant neoplasm: Liver cell carcinoma","Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)",Non-interventional,NA,NA,NA,NA,N/A,"- Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.; time frame: up to 54 months
- Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).; time frame: up to 54 months
","- Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.; time frame: up to 54 months
- Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.; time frame: up to 54 months
- Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.; time frame: up to 54 months
- Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.; time frame: up to 54 months
- Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).; time frame: up to 54 months
- Tumor status at different visits will be evaluated according to radiological or clinical evaluation. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.; time frame: up to 54 months
- Further possible prognostic factors will be evaluated.; time frame: up to 54 months
- Safety variables will be summarized using descriptive statistics based on adverse events collection.; time frame: up to 54 months
",Germany,[---]* Many Locations; University Medical Center Freiburg im Breisgau,2013-08-31,NA,500,NA,"- Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma
(BCLC-B) for whom the decision has been taken by the investigator to prescribe
Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients
with large/multifocal HCC who do not have cancer related symptoms, macrovascular
invasion or extrahepatic spread).
",- Prior targeted therapy for hepatocellular carcinoma.
,SORINT - SORafenib for Treatment of Patients With INTermediate Stage Hepatocellular Carcinoma,Recruiting ongoing,Bayer; Bayer; [---]*,[---]*; [---]*; clinical-trials-contact@bayerhealthcare.com,"Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)",2013-08-31,2013-07-23,2013-07-23,19,Observational,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2013,2015-11-10,TRUE,TRUE,FALSE
6487,NCT02165917,NA,NCT02165917,NCT: 2014-04-15 ICTRP: 2014-04-15 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,Excision incorrectly registered as placebo (should be active comparator). No dosage of GnRH-analogue (probably at discretion of physician),5,NA,NA,3,NA,"no AM, no metric",NCT: Anticipated 60 ICTRP: 60 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,Outcome missing,kein Artikel,NA,NA,2014-06-18,NA,2015-05-31,2017-05-31,Interventional,Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier,"Randomised, Controlled Clinical Study With Patients With Endometriosis and the Desire to Have Children - Comparison Between Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesionbarrier",Unknown status,Phase 4,60,Anticipated,Pius-Hospital Oldenburg,Pregnancy rate,Endometriosis-associated pain;Endometriosis-associated pain,PHDW-003;PHDW-003,Study to Compare Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesion Barrier,"Randomised, Controlled Clinical Study With Patients With Endometriosis and the Desire to Have Children - Comparison Between Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesionbarrier",;gyn-sekretariat@pius-hospital.de;gyn-sekretariat@pius-hospital.de;;gyn-sekretariat@pius-hospital.de;gyn-sekretariat@pius-hospital.de,;gyn-sekretariat@pius-hospital.de;gyn-sekretariat@pius-hospital.de;;gyn-sekretariat@pius-hospital.de;gyn-sekretariat@pius-hospital.de,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment",Phase 4,2014-04-15,2015-05-20,60,Recruiting,Pius-Hospital Oldenburg,NULL,germany;germany,Procedure: Excision plus hyaluronic acid gel;Procedure: Excision only;Procedure: Excision plus hyaluronic acid gel;Procedure: Excision only,"
Inclusion Criteria:
- Women over 18 years with endometriosis-associated pain, like dysmenorrhea,
dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only
one criterion needs to be fulfilled for study inclusion);
- Participants are in good general health except for endometriosis related problems;
- Except for endometriosis, no existence of an obvious diseases which could cause
chronic pain or which could cause abdominal pain;
- The participant must have a desire to have children;
- Participants must be able to give their consent and must understand the risks
associated with a participation in the study;
- There must be a signed and dated informed consent which was accepted by the local
ethic committee
Exclusion Criteria:
- Existent pregnancy including ectopic pregnancy;
- Identification of other causes for the discomfort;
- Chronic diseases, except endometriosis, which require continuous pain therapy;
- Previous application of GnRH analogues 6 month prior to study;
- Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation;
- Planned additional general surgical procedures during the operation for removal of
the endometriotic lesions;
- Absence of endometriosis at laparoscopy;
- Partial resection of the bowel or urinary bladder for removal of endometriosis
;
Inclusion Criteria:
- Women over 18 years with endometriosis-associated pain, like dysmenorrhea,
dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only
one criterion needs to be fulfilled for study inclusion);
- Participants are in good general health except for endometriosis related problems;
- Except for endometriosis, no existence of an obvious diseases which could cause
chronic pain or which could cause abdominal pain;
- The participant must have a desire to have children;
- Participants must be able to give their consent and must understand the risks
associated with a participation in the study;
- There must be a signed and dated informed consent which was accepted by the local
ethic committee
Exclusion Criteria:
- Existent pregnancy including ectopic pregnancy;
- Identification of other causes for the discomfort;
- Chronic diseases, except endometriosis, which require continuous pain therapy;
- Previous application of GnRH analogues 6 month prior to study;
- Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation;
- Planned additional general surgical procedures during the operation for removal of
the endometriotic lesions;
- Absence of endometriosis at laparoscopy;
- Partial resection of the bowel or urinary bladder for removal of endometriosis
",NULL,Pregnancy rate;Pregnancy rate,Endometriosis-associated pain;Endometriosis-associated pain;Endometriosis-associated pain;Endometriosis-associated pain,NCT02165917; PHDW-003,2016-03-22,yes,Endometriosis; Endometriosis,Arm 1 Device: Excision plus Hyalobarrier; Arm 2 Procedure: Excision only,Interventional,Randomized controlled trial,Blinded,Active control (effective treament of control group),Parallel,N/A,- Pregnancy rate; time frame: One year after completion of endometriosis treatment (excision followed by 3 month of GnRH-analogues)
,- Endometriosis-associated pain; time frame: The day before laparoscopy is performed; Outcome measure is measured by visual analogue scale
- Endometriosis-associated pain; time frame: One year after completion of endometriosis treatment; Outcome measure is measured by visual analogue scale
,Germany,[---]* Oldenburg,2014-08-31,NA,60,NA,"- Women over 18 years with endometriosis-associated pain, like dysmenorrhea,
dyspareunia, lower abdominal pain, low-back pain, rectal pain, defecation pain (only
one criterion needs to be fulfilled for study inclusion);
- Participants are in good general health except for endometriosis related problems;
- Except for endometriosis, no existence of an obvious diseases which could cause
chronic pain or which could cause abdominal pain;
- The participant must have a desire to have children;
- Participants must be able to give their consent and must understand the risks
associated with a participation in the study;
- There must be a signed and dated informed consent which was accepted by the local
ethic committee
","- Existent pregnancy including ectopic pregnancy;
- Identification of other causes for the discomfort;
- Chronic diseases, except endometriosis, which require continuous pain therapy;
- Previous application of GnRH analogues 6 month prior to study;
- Concurrent use of systemic corticosteroids, antineoplastic agents and/or radiation;
- Planned additional general surgical procedures during the operation for removal of
the endometriotic lesions;
- Absence of endometriosis at laparoscopy;
- Partial resection of the bowel or urinary bladder for removal of endometriosis
","Randomised, Controlled Clinical Study With Patients With Endometriosis and the Desire to Have Children - Comparison Between Peritoneal Ablation by Excision Only and Excision With the Use of an Adhesionbarrier",Recruiting planned,"Pius-Hospital Oldenburg; Pius-Hospital Oldenburg, Department of Gynecology, Obstetrics and Gynecological Oncology; [---]*",[---]*; [---]*; gyn-sekretariat@pius-hospital.de,Arm 1 Device: Excision plus Hyalobarrier; Arm 2 Procedure: Excision only,2015-05-31,2014-04-15,2014-04-15,60,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2015,2015-11-02,TRUE,TRUE,FALSE
17589,NCT00249795,NA,NCT00249795,NCT: 2005-11-04 ICTRP: 2005-11-04 DRKS: NA,1,1,NA,2,1,r,Reference to criteria from ACTIVE A but unclear where to find those. Paper: Only some criteria could be checked.,2,1,NA,3,1,"no AM, no measure",3,1,"no AM, no measure",NCT: Actual 9016 ICTRP: 9016 DRKS: NA,9016,1,1,2,0,NA,"Triple (Participant, Investigator, Outcomes Assessor)",Double,worse,1,NA,ganzer Artikel,https://doi.org/10.1056/nejmoa1008816,2011-03-10,2005-11-07,NA,2003-06-30,2009-08-31,Interventional,Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I),"A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation",Completed,Phase 3,9016,Actual,Sanofi,"First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication;First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication",First Hospitalisation for Other Cardiovascular (CV) Cause;First Occurrence of Stroke;Death From Any Cause;First Occurrence of Any Heart Failure (HF) Episode;First Hospitalisation for Heart Failure (HF),Clopidogrel (SR25990);EFC4912 I,Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I),"A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation",;;;,;;;,Interventional,,Phase 3,2005-11-04,2003-06-20,9016,Completed,Sanofi,Bristol-Myers Squibb,united states;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;united states;israel;russian federation;turkey;united states;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;united states;israel;russian federation;turkey;united states;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;united states;israel;russian federation;turkey;united states;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;argentina;australia;austria;belgium;brazil;canada;chile;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;malaysia;mexico;netherlands;norway;poland;portugal;singapore;south africa;spain;sweden;switzerland;taiwan;united kingdom;united states;israel;russian federation;turkey,Drug: Irbesartan;Drug: placebo;Drug: Irbesartan;Drug: placebo;Drug: Irbesartan;Drug: placebo;Drug: Irbesartan;Drug: placebo,"
Inclusion Criteria:
Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:
- have a systolic blood pressure of at least 110 mmHg
- not already receiving an angiotensin receptor blocking agent, unless they are willing
and able to be changed to another antihypertensive agent
- no previous intolerance to angiotensin receptor blocking agents
- no proven indication for angiotensin receptor blocking agents, unless an Angiotensin
Converting Enzyme (ACE) inhibitor can be substituted
Exclusion Criteria:
Patients will be excluded from ACTIVE study if any of the following are present:
- requirement for clopidogrel (such as recent coronary stent procedure)
- requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
- prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel
- documented peptic ulcer disease within the previous 6 months
- prior intracerebral hemorrhage
- significant thrombocytopenia (platelet count <50 x 10(9)/L)
- psychosocial reason making study participation impractical
- geographic reason making study participation impractical
- ongoing alcohol abuse
- mitral stenosis
- pregnant or nursing woman or woman of child bearing potential and not on effective
birth control for at least one month prior to start of study or not willing to
continue on birth control for duration of study
- severe comorbid condition such that the patient is not expected to survive 6 months
- patient currently receiving an investigational pharmacologic agent
- requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor
nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE
A
;
Inclusion Criteria:
Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:
- have a systolic blood pressure of at least 110 mmHg
- not already receiving an angiotensin receptor blocking agent, unless they are willing
and able to be changed to another antihypertensive agent
- no previous intolerance to angiotensin receptor blocking agents
- no proven indication for angiotensin receptor blocking agents, unless an Angiotensin
Converting Enzyme (ACE) inhibitor can be substituted
Exclusion Criteria:
Patients will be excluded from ACTIVE study if any of the following are present:
- requirement for clopidogrel (such as recent coronary stent procedure)
- requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
- prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel
- documented peptic ulcer disease within the previous 6 months
- prior intracerebral hemorrhage
- significant thrombocytopenia (platelet count <50 x 10(9)/L)
- psychosocial reason making study participation impractical
- geographic reason making study participation impractical
- ongoing alcohol abuse
- mitral stenosis
- pregnant or nursing woman or woman of child bearing potential and not on effective
birth control for at least one month prior to start of study or not willing to
continue on birth control for duration of study
- severe comorbid condition such that the patient is not expected to survive 6 months
- patient currently receiving an investigational pharmacologic agent
- requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor
nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE
A
;
Inclusion Criteria:
Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:
- have a systolic blood pressure of at least 110 mmHg
- not already receiving an angiotensin receptor blocking agent, unless they are willing
and able to be changed to another antihypertensive agent
- no previous intolerance to angiotensin receptor blocking agents
- no proven indication for angiotensin receptor blocking agents, unless an Angiotensin
Converting Enzyme (ACE) inhibitor can be substituted
Exclusion Criteria:
Patients will be excluded from ACTIVE study if any of the following are present:
- requirement for clopidogrel (such as recent coronary stent procedure)
- requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
- prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel
- documented peptic ulcer disease within the previous 6 months
- prior intracerebral hemorrhage
- significant thrombocytopenia (platelet count <50 x 10(9)/L)
- psychosocial reason making study participation impractical
- geographic reason making study participation impractical
- ongoing alcohol abuse
- mitral stenosis
- pregnant or nursing woman or woman of child bearing potential and not on effective
birth control for at least one month prior to start of study or not willing to
continue on birth control for duration of study
- severe comorbid condition such that the patient is not expected to survive 6 months
- patient currently receiving an investigational pharmacologic agent
- requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor
nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE
A
;
Inclusion Criteria:
Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:
- have a systolic blood pressure of at least 110 mmHg
- not already receiving an angiotensin receptor blocking agent, unless they are willing
and able to be changed to another antihypertensive agent
- no previous intolerance to angiotensin receptor blocking agents
- no proven indication for angiotensin receptor blocking agents, unless an Angiotensin
Converting Enzyme (ACE) inhibitor can be substituted
Exclusion Criteria:
Patients will be excluded from ACTIVE study if any of the following are present:
- requirement for clopidogrel (such as recent coronary stent procedure)
- requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
- prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel
- documented peptic ulcer disease within the previous 6 months
- prior intracerebral hemorrhage
- significant thrombocytopenia (platelet count <50 x 10(9)/L)
- psychosocial reason making study participation impractical
- geographic reason making study participation impractical
- ongoing alcohol abuse
- mitral stenosis
- pregnant or nursing woman or woman of child bearing potential and not on effective
birth control for at least one month prior to start of study or not willing to
continue on birth control for duration of study
- severe comorbid condition such that the patient is not expected to survive 6 months
- patient currently receiving an investigational pharmacologic agent
- requirement for chronic (> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor
nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE
A
",NULL,"First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication;First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication;First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication;First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication",First Occurrence of Stroke;Death From Any Cause;First Occurrence of Any Heart Failure (HF) Episode;First Hospitalisation for Heart Failure (HF);First Hospitalisation for Other Cardiovascular (CV) Cause,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-06-30,2005-11-04,2005-11-04,9016,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2010-09-29,TRUE,FALSE,FALSE
10194,NCT01458574,NA,NCT01458574,NCT: 2011-10-21 ICTRP: 2011-10-21 DRKS: NA,1,1,NA,0,NA,NA,"Reference to criteria from two other trials, but unclear where to find those.",2,1,NA,3,1,NA,3,1,NA,NCT: Actual 593 ICTRP: 593 DRKS: NA,593,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1056/nejmoa1606910,2017-05-04,2011-10-25,NA,2012-07-20,2016-05-27,Interventional,"A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis","A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis",Completed,Phase 3,593,Actual,Pfizer,Percentage of Participants In Remission at Week 52,"Percentage of Participants With Mucosal Healing at Week 52;Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline;Percentage of Participants in Remission at Week 24;Percentage of Participants in Sustained Remission;Percentage of Participants With Mucosal Healing at Week 24;Percentage of Participants With Sustained Mucosal Healing;Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline;Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline;Percentage of Participants With Clinical Response at Week 24 and 52;Percentage of Participants With Sustained Clinical Response;Percentage of Participants in Clinical Remission at Week 24 and 52;Percentage of Participants in Sustained Clinical Remission;Percentage of Participants in Deep Remission at Week 24 and 52;Percentage of Participants in Sustained Deep Remission;Percentage of Participants in Symptomatic Remission at Week 24 and 52;Percentage of Participants in Sustained Symptomatic Remission;Percentage of Participants in Endoscopic Remission at Week 24 and 52;Percentage of Participants in Sustained Endoscopic Remission;Total Mayo Score at Baseline, Week 24 and 52;Change From Baseline in Total Mayo Score at Week 24 and 52;Percentage of Participants in Remission, Among Participants With Remission at Baseline;Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline;Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline;Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline;Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline",2011-004580-79;OCTAVESUSTAIN;A3921096,"A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis","A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2011-10-21,2012-07-20,593,Completed,Pfizer,NULL,"united states;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;united states;united states;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;united states;united states;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;united states;united states;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;united states;united states;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;australia;austria;belgium;brazil;canada;colombia;croatia;czech republic;denmark;estonia;france;germany;hungary;israel;italy;japan;korea, republic of;latvia;netherlands;new zealand;poland;romania;russian federation;serbia;slovakia;south africa;spain;taiwan;ukraine;united kingdom;united states","Drug: Placebo;Drug: CP690,550;Drug: CP-690,550;Drug: Placebo;Drug: CP690,550;Drug: CP-690,550;Drug: Placebo;Drug: CP690,550;Drug: CP-690,550;Drug: Placebo;Drug: CP690,550;Drug: CP-690,550","
Inclusion Criteria:
- Subjects who met study entry criteria and completed 8-week induction treatment from
Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study
enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
Exclusion Criteria:
- Subjects who had major protocol violation (as determined by the Sponsor) in Study
A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely
to require surgery for UC during the study period.
;
Inclusion Criteria:
- Subjects who met study entry criteria and completed 8-week induction treatment from
Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study
enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
Exclusion Criteria:
- Subjects who had major protocol violation (as determined by the Sponsor) in Study
A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely
to require surgery for UC during the study period.
;
Inclusion Criteria:
- Subjects who met study entry criteria and completed 8-week induction treatment from
Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study
enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
Exclusion Criteria:
- Subjects who had major protocol violation (as determined by the Sponsor) in Study
A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely
to require surgery for UC during the study period.
;
Inclusion Criteria:
- Subjects who met study entry criteria and completed 8-week induction treatment from
Study A3921094 or A3921095
- Subjects who achieved clinical response in Study A3921094 or A3921095
- Women of childbearing potential must test negative for pregnancy prior to study
enrollment
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures
- Evidence of a personally signed and dated informed consent document(s) indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.
Exclusion Criteria:
- Subjects who had major protocol violation (as determined by the Sponsor) in Study
A3921094 or A3921095
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease
- Subjects who have had surgery for UC or in the opinion of the investigator, are likely
to require surgery for UC during the study period.
",NULL,Percentage of Participants In Remission at Week 52;Percentage of Participants In Remission at Week 52;Percentage of Participants In Remission at Week 52,"Percentage of Participants With Mucosal Healing at Week 52;Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline;Percentage of Participants in Remission at Week 24;Percentage of Participants in Sustained Remission;Percentage of Participants With Mucosal Healing at Week 24;Percentage of Participants With Sustained Mucosal Healing;Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline;Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline;Percentage of Participants With Clinical Response at Week 24 and 52;Percentage of Participants With Sustained Clinical Response;Percentage of Participants in Clinical Remission at Week 24 and 52;Percentage of Participants in Sustained Clinical Remission;Percentage of Participants in Deep Remission at Week 24 and 52;Percentage of Participants in Sustained Deep Remission;Percentage of Participants in Symptomatic Remission at Week 24 and 52;Percentage of Participants in Sustained Symptomatic Remission;Percentage of Participants in Endoscopic Remission at Week 24 and 52;Percentage of Participants in Sustained Endoscopic Remission;Total Mayo Score at Baseline, Week 24 and 52;Change From Baseline in Total Mayo Score at Week 24 and 52;Percentage of Participants in Remission, Among Participants With Remission at Baseline;Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline;Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline;Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline;Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-07-20,2011-10-21,2011-10-21,593,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,2017-04-07,TRUE,FALSE,TRUE
9795,NCT01522898,NA,NCT01522898,NCT: 2012-01-25 ICTRP: 2012-01-25 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 145 ICTRP: 590 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,kein Artikel,https://doi.org/10.1007/s10840-018-0429-9,NA,2012-02-01,NA,2013-03-31,2020-08-31,Interventional,Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF),Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation,Completed,N/A,145,Actual,University of Adelaide,All-cause mortality and non-fatal heart failure events,All-cause mortality;Cardiovascular mortality;Non-Fatal Heart Failure Events;6-minute walking distance;Quality of Life questionnaires;Unplanned Hospitalization;Ventricular arrhythmias requiring device therapy,RAH-HREC-Protocol-#111234,Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF),Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation,,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2012-01-25,2013-03-20,145,Completed,University of Adelaide,Medtronic;Abbott Medical Devices;Boston Scientific Corporation,australia;germany;malaysia;new zealand;united kingdom;australia;germany;malaysia;new zealand;united kingdom,Procedure: AV nodal ablation;Drug: Medical Ventricular Rate Control,"
Inclusion Criteria:
- Age = 18 years old
- Persistent (= 1 month) or permanent atrial fibrillation. Persistent AF will be where
obtaining and maintaining sinus rhythm is deemed either not worthwhile, or to be
ineffective in the long term, or where both the patient and physician accept the
presence of AF, where rhythm control intervention is, by definition no longer pursued.
Permanent AF is defined as atrial fibrillation where sinus rhythm cannot be restored.
- NYHA class II , III or ambulatory class IV heart failure
- Left Ventricular Ejection Fraction (LVEF) = 35% by objective criteria such as
echocardiography, or cardiac MRI
- QRS duration on 12-lead ECG = 120ms
- Able and willing to comply with all pre-, post- and follow-up testing and
requirements.
Exclusion Criteria:
- age < 18 years
- pregnancy
- previous AV nodal ablation
- Second or third degree AV block
- Inability to provide informed consent
- life expectancy less than 24 months due to co-morbid illness other than heart failure
erg cancer, end-stage renal disease, liver failure
- Paroxysmal Atrial Fibrillation that self terminates within 7 days
",NULL,All-cause mortality and non-fatal heart failure events,All-cause mortality;Cardiovascular mortality;Non-Fatal Heart Failure Events;6-minute walking distance;Quality of Life questionnaires;Unplanned Hospitalization;Ventricular arrhythmias requiring device therapy,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-03-31,2012-01-25,2012-01-25,145,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2013,2020-11-11,TRUE,FALSE,FALSE
18166,NCT00153530,NA,NCT00153530,NCT: 2005-09-08 ICTRP: 2005-09-08 DRKS: NA,1,1,NA,2,1,NA,NA,2,0,"Details on intervention from study description; MTX was given identical to protocol, but additionally ifosfamide, mentioned as protocol amendment in paper.",5,1,NA,4,1,no measure,NCT: Anticipated 604 ICTRP: 604 DRKS: NA,551,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,ganzer Artikel,https://doi.org/10.1016/s1470-2045(10)70229-1,2010-10-21,2005-09-12,NA,2000-05-31,2009-05-31,Interventional,Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL),Phase IV Study on the Role of Whole Brain Irradiation in Primary CNS Lymphoma (PCNSL) After High-dose Methotrexate,Completed,Phase 4,604,Anticipated,"Charite University, Berlin, Germany",overall survival,progression-free survival,G-PCNSL-SG1,Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL),Phase IV Study on the Role of Whole Brain Irradiation in Primary CNS Lymphoma (PCNSL) After High-dose Methotrexate,,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 4,2005-09-08,2000-05-20,604,Completed,"Charite University, Berlin, Germany",University Hospital Tuebingen,germany,Drug: methotrexate;Radiation: radiotherapy,"
Inclusion Criteria:
- Histologically or cytologically/immunocytologically confirmed primary non-Hodgkin's
lymphoma of the CNS. A central reference pathological report will be made on
inclusion into the study (Prof. Dr. Pietsch, Reference Center for Brain Tumors of the
German Society for Neuropathology and Neuroanatomy, Institute of Neuropathology of
the Bonn University Hospital). Histological diagnosis is usually performed by
preferential stereotactic biopsy of suspicious lesions in the brain or spinal cord.
The diagnosis from cerebrospinal fluid (CSF) requires the detection of malignant
lymphocytes according to cytological and immunocytological criteria. There should be
no more than 2 weeks between establishing the diagnosis and inclusion in the study.
The availability of the reference pathological report is not absolutely necessary for
inclusion in the study and beginning therapy.
- Aged > 18 years
- Life expectancy of at least 2 months
- Adequate bone marrow reserve with a peripheral granulocyte count of > 1,500/µl and
thrombocyte count of > 100,000/µl; bilirubin in the normal range; GOT of < three
times the upper normal limit and adequate renal function with a creatinine clearance
of > 50 ml/min and serum creatinine in the normal range.
- Written informed consent
- In women of child-bearing age, pregnancy is excluded, effective contraception is
necessary, and women should not be breast feeding.
Exclusion Criteria:
- Manifestation of lymphoma outside of the CNS
- Severe diseases in other organs which would make performing intensive chemotherapy
impossible; Karnofsky index > 50% due to previous diseases other than PCNSL.
Karnofsky > 30 will be accepted only due to the PCNSL.
- Active infection
- HIV positivity
- Previous treatment of PCNSL other than with corticosteroids, antiepileptics or
diuretics
- Previous radiotherapy of the brain
- Concomitant or previous malignant diseases in the last 5 years except for an
adequately treated basal cell carcinoma or cervical carcinoma in situ
- Immunosuppression, concomitant immunosuppressive therapy, or organ transplantation
- Ongoing chemotherapy for another disease
",NULL,overall survival,progression-free survival,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-05-31,2005-09-08,2005-09-08,604,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2000,2009-12-23,TRUE,FALSE,FALSE
15152,NCT00640549,NA,NCT00640549,NCT: 2008-03-14 ICTRP: 2008-03-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,Aggregation Method missing,4,NA,Aggregation Method missing,NCT: Actual 41 ICTRP: 41 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2008-03-21,NA,2003-03-31,2004-10-31,Interventional,Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus,"Impact of Atorvastatin on the Distribution, Composition, and Metabolism of LDL and HDL Subfractions: A Double-Blind Placebo-Controlled Phase IV Study With Patients Suffering From Combined Hyperlipidemia and Diabetes. Atorvastatin and LDL Profile in NIDDM (ALPIN Study)",Terminated,Phase 4,41,Actual,Pfizer,Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1);Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1),"Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1);Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1);Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1);Changes in size of LDL subfractions compared with screening (visit 1)",A2581040,Atorvastatin and LDL Profile in Non-Insulin Dependent Diabetes Mellitus,"Impact of Atorvastatin on the Distribution, Composition, and Metabolism of LDL and HDL Subfractions: A Double-Blind Placebo-Controlled Phase IV Study With Patients Suffering From Combined Hyperlipidemia and Diabetes. Atorvastatin and LDL Profile in NIDDM (ALPIN Study)",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",Phase 4,2008-03-14,2003-03-20,41,Terminated,Pfizer,NULL,germany,Drug: Atorvastatin;Drug: Placebo,"
Inclusion Criteria:
- Male and female subjects with a diagnosis of type 2 diabetes mellitus who either have
never had a major adverse cardiac event (MACE) diagnosed before or who had a MACE
diagnosed at least 6 months ago, but who, according to the judgement of the treating
general practitioner, do not receive any hyperlipidemic therapy. Major adverse
cardiac events (MACE) include myocardial infarction, coronary angioplasty, coronary
artery bypass graft or other revascularization procedures.
At Screening:
Visit 1 (week -4):
1. Male patients aged >35 and =75 years and postmenopausal female patients =75 years
with a diagnosis of type 2 diabetes mellitus
2. Patients have been euthyroid for at least six months
3. Written informed consent obtained
At Visit 2 (week 0):
4. LDL cholesterol =130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)
5. Triglycerides <150 mg/dl (1.69 mmol/l ) and <600 mg/dl (11.3 mmol/l)
6. Sum of LDL-5 and LDL-6 cholesterol =25 mg/dl (0.65 mmol/l)
7. Follicle stimulating Hormone (FSH) >30 U/l in female patients aged <60 years or FSH
>20 U/l in female patients aged =60 years
Exclusion Criteria:
- HbA1c > 8.0
- Creatine kinase (CK) >5 times the upper limit of normal
- Patients having taken lipid lowering medication within 8 weeks of the screening visit
",NULL,Changes in concentration of HDL subfractions 2a and 2b compared with screening (visit 1);Changes in concentration of LDL subfractions LDL-5 and LDL-6 compared with screening (visit 1),"Changes in concentration of apolipoprotein B in VLDL, IDL, LDL-1 through LDL-6 and apolipoprotein A I in HDL subfractions 2a, 2b, and HDL-3 compared with screening (visit 1);Changes in Cholesterol ester transfer protein (CETP), lipoprotein and hepatic lipase activity compared with screening (visit 1);Changes in concentration of triglycerides, LDL, and HDL compared with screening (visit 1);Changes in size of LDL subfractions compared with screening (visit 1)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-03-31,2008-03-14,2008-03-14,41,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2008-03-28,TRUE,FALSE,FALSE
13246,NCT00975000,NA,NA,NCT: 2009-09-10 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no AM,NCT: Actual 114 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,"Outcome just given as ""efficacy""",kein Artikel,NA,NA,2009-09-11,NA,2009-12-03,2013-04-16,Interventional,Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism",Completed,Phase 3,114,Actual,Amgen,Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP),Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck;Change From Baseline to the EAP in Mean Serum Phosphorus;Change From Baseline to Week 52 in eGFR;Change From Baseline to the EAP in Corrected Total Calcium;Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH);Change From Baseline to the EAP in Urine Phosphorus;Percentage of Participants With a Parathyroidectomy;Time to Parathyroidectomy,20062007,Treatment of Autonomous Hyperparathyroidism in Post Renal Transplant Recipients,"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2009-09-10,2009-12-03,114,Completed,Amgen,NULL,united states;australia;austria;belgium;canada;france;germany;italy;poland;spain;switzerland;australia;austria;belgium;canada;france;germany;italy;poland;spain;switzerland;united states,Drug: Cinacalcet;Drug: Placebo,"
Inclusion Criteria:
- Received a kidney transplant = 9 weeks at time of Screening and = 24 months before
first dose
- May be the first kidney transplant or a repeat kidney transplant.
- Subjects with a functional, stable kidney transplant, defined as MDRD estimated
glomerular filtration rate (eGFR) = 30 mL/min/1.73 m² (chromic kidney disease stage 3
or better) at Screening.
- Men or women = 18 years at the start of Screening (ie, time of informed consent).
- Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2
values in Screening period.
- iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen
1 or Screen 2).
Exclusion Criteria:
- Received cinacalcet therapy post-transplant for more than 14 days cumulatively
post-transplant. If cinacalcet therapy was received for a total of 14 days or less
post-transplant, there must be a 4-week washout before subject is eligible for
screening (Note: This does not exclude pre-transplant use of cinacalcet).
- Anticipated parathyroidectomy within 6 to12 months after Randomization.
- Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.
- Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites
or analogues) or use within 30 days prior to Screening.
- Ongoing use of calcium supplements or use within 30 days prior to Screening.
- Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30
days prior to Screening.
- Ongoing use of a thiazide diuretic.
- Subjects with a history of seizures who had a seizure within the 3 months prior to
Randomization, which required adjustments to the seizure medication.
- Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it
is an institutional protocol-driven biopsy.
",NULL,Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP),Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck;Change From Baseline to the EAP in Mean Serum Phosphorus;Change From Baseline to Week 52 in eGFR;Change From Baseline to the EAP in Corrected Total Calcium;Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH);Change From Baseline to the EAP in Urine Phosphorus;Percentage of Participants With a Parathyroidectomy;Time to Parathyroidectomy,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-12-03,2009-09-10,2009-09-10,114,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2009,2018-09-20,TRUE,FALSE,TRUE
7471,NCT01964378,NA,NA,NCT: 2013-10-07 ICTRP: NA DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 200 ICTRP: NA DRKS: NA,126,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Double,worse,1,NA,ganzer Artikel,https://doi.org/10.1002/ejp.1331,2018-10-26,2013-10-17,NA,2013-10-29,2015-10-16,Interventional,CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer,"Efficacy, Safety, and Tolerability of Oral Cebranopadol Versus Morphine Sulfate PR in Subjects With Chronic Moderate to Severe Pain Related to Cancer.",Terminated,Phase 3,200,Actual,Grünenthal GmbH,Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set);Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set),Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period,2012-001316-35;U1111-1143-1808;KF6005/07,CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer,"Efficacy, Safety, and Tolerability of Oral Cebranopadol Versus Morphine Sulfate PR in Subjects With Chronic Moderate to Severe Pain Related to Cancer.",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2013-10-07,2013-10-29,200,Terminated,Grünenthal GmbH,NULL,austria;belgium;bulgaria;chile;croatia;denmark;germany;hungary;poland;romania;serbia;slovakia;spain;united kingdom;austria;belgium;bulgaria;chile;croatia;denmark;germany;hungary;poland;romania;serbia;slovakia;spain;united kingdom;france;netherlands;peru;sweden,Drug: Cebranopadol;Drug: Morphine Prolonged Release,"
Inclusion Criteria:
1. Signed informed consent.
2. Negative pregnancy test before first dose.
3. Female and male participants willing to use acceptable and highly effective methods of
birth control.
4. The following criteria must be fulfilled by participants:
1. Require daily analgesia for their pain,
2. Diagnosed with active cancer,
3. Receiving daily opioid treatment at doses not higher than 90 mg oral morphine or
its equivalent (World Health Organization Step II and Step III analgesics) for an
appropriate length of time,
4. Participants must be dissatisfied with their current pain treatment,
5. Participants must be suffering from cancer-related but not cancer therapy-related
chronic pain for a period of 4 weeks or more prior to enrollment.
5. Eastern Cooperation Oncology Group (ECOG) score 2 or below.
6. Average pain intensity over the last 24 hours of 5 or more calculated from the pain
assessments recorded during the last 3 days prior to randomization.
7. Compliance with the use of the electronic diary defined as at least 3 out of 4 of the
24 hour Numerical Rating Scale entries available during the last 4 days prior to and
including the day of allocation to treatment.
Exclusion Criteria:
1. Evidence of ongoing alcohol and or drug abuse and/or a history of alcohol and/or drug
abuse within the last 2 years.
2. A clinically significant disease other than cancer which in the investigator's opinion
may affect efficacy or safety assessments e.g., significant unstable cardiac,
vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious disease,
psychiatric (resulting in disorientation, memory impairment or inability to report
accurately) or metabolic disorders.
3. Any gastrointestinal disorder that could affect the absorption and/or elimination of
Investigational Medicinal Product.
4. Any planned major surgery during the trial.
5. Known to or suspected of not being able to comply with the trial protocol and the use
of Investigational Medicinal Product.
6. History of seizure disorder and/or epilepsy or any condition associated with a
significant risk of seizure or epilepsy.
7. Known history and/or presence of cerebral tumor or cerebral metastases.
8. Moderate to severe hepatic impairment corresponding to Child-Pugh classification B and
C. Impaired hepatic cellular integrity indicated by aspartate transaminase or alanine
transaminase greater than 3 times the upper limit of normal at the Enrollment Visit.
9. Inadequate baseline bone marrow reserve with a white blood cell count below 2000/µL, a
platelet count 100 000/µL or less, and a hemoglobin level below 8 g/dL at the
Enrollment Visit.
10. Impaired renal function. Creatinine clearance less than 60 mL per minute(as per
amendment 45 mL per minute) at the Enrollment Visit (calculated from the
Cockcroft-Gault formula).
11. Forbidden concomitant medications
12. Uncontrolled hypertension
13. Clinically relevant history of hypersensitivity, allergy or contraindications to
opioid medication or any of the excipients of morphine sulfate (Prolonged Released or
Immediate Release), or cebranopadol film-coated tablets.
14. Chronic hepatitis B or C, or human immunodeficiency virus (HIV) known by history, or
presence of active hepatitis B or C within the 3 months before the Enrollment Visit.
15. History of torsade de pointes and/or presence of risk factors for torsade de pointes
(e.g., heart failure, hypokalemia, or bradycardia).
16. Marked prolongation of corrected QT interval (Fridericia) (greater than 450
milliseconds) at the Enrollment Visit.
17. Employees of the sponsor, investigator, or trial site or family members of the
employees, sponsor, or investigator.
18. Concurrent participation in another trial or planning to be enrolled in another
clinical trial (i.e., administration of experimental treatment in another clinical
trial) during the course of this trial.
19. Previous participation in this or other trials with cebranopadol with the following
exceptions:
- Participants who failed enrollment in this trial only because of exclusion
criterion 10, and who may now be eligible can be re-enrolled.
- Participants who failed enrollment due to technical failure of equipment (e.g.,
ECG machine and e-diary device).
20. Participant has received an experimental drug or used an experimental medical device
within 30 days before the planned start of treatment.
21. Currently not receiving opioid treatment for cancer-related pain at the enrollment
visit (i.e., opioid naïve).
",NULL,Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set);Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set),Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-10-29,2013-10-07,2013-10-07,200,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,2020-02-13,TRUE,FALSE,TRUE
14961,NCT00676429,NA,NA,NCT: 2008-05-09 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,No AM,4,NA,No AM,NCT: Actual 51 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,No outcome,kein Artikel,NA,NA,2008-05-13,NA,2006-07-31,2008-06-30,Interventional,Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders,"Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders in Children and Adolescents - a Placebo Controlled, Randomized, Double Blind Clinical Trial",Completed,Phase 2,51,Actual,University Hospital Freiburg,Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ): Combined subscales Conduct Problem and Oppositional Behavior,"Assessment of the safety and tolerability by adverse event documentation.;Assessment of the efficacy by the Clinical Global Impressions-Severity of Illness scale (CGI-S) and the Global Impressions-Improvement scale (CGI-I).;Correlation between dosage, efficacy and adverse events.;Ziprasidone serum levels;Correlation between serum level, efficacy and adverse events",EudraCT: 2006-002207-13;NRA1280023,Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders,"Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders in Children and Adolescents - a Placebo Controlled, Randomized, Double Blind Clinical Trial",;;,;;,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2,2008-05-09,2006-07-20,51,Completed,University Hospital Freiburg,Pfizer,germany,Drug: Ziprasidone Hydrochloride;Drug: Placebo,"
Inclusion Criteria:
- The subject and the authorized legal representative must understand the nature of the
study and be able to comply with protocol requirements. The representative must sign
an Informed Consent Document and the subject must provide Written Assent.
- The subject (male or female) must be between 7-17 (inclusive) years of age at
screening.
- The subject must have a primary diagnosis of Conduct Disorder [CD] (312.8),
Oppositional Defiant Disorder [ODD] (313.81) or Disruptive Behavior Disorder not
otherwise specified [DBD-NOS] (312.9) as defined by DSM-IV criteria and confirmed by
the Kiddie-SADS-PL.
- At the screening visit (Visit 1), subjects must have a score of 21 or more on the sum
of the scales for conduct problems and for oppositional behaviour in the NCBRF-TIQ.
- In the investigator's opinion, the subject must be likely to benefit from the
therapy.
- The subject is willing and able to discontinue any medications that are prohibited in
this study (see Concomitant Medications table, Section 3.5.1). Any such medications
must be discontinued at least 5 half-lives prior to the administration of
double-blinded study medication.
- Patients who are receiving prohibited medications are to be considered for the
protocol only If discontinuation of the medication does not compromise the welfare of
the patient and/or alternative medication that is allowed by the protocol is
available and appropriate for the patient. Psychotropic medications should be tapered
down per accepted medical practice and the specific package insert instead of being
abruptly discontinued.
- Females of childbearing potential may be included provided that they are not
pregnant, not nursing, and are practicing effective contraception and meet all of the
following criteria:
- Are instructed and agree to avoid pregnancy during the study.
- Have a negative pregnancy test (ß-HCG) at screening and Visit 2.
- Use one of the following birth control methods:
- an oral contraceptive agent, an intrauterine device (ILTD), an implantable
contraceptive (e.g. Norplant), transdermal hormonal contraceptive (e.g.
Ortho-Evra), or an injectable contraceptive (e.g. Depo-Provera) for at
least one month prior to entering the study and will continue its use
throughout the study; or
- a barrier method of contraception, e.g., condom and / or diaphragm with
spermicide while participating in the study.
- abstinence for at least 3 months before the start of the study and
intention to abstain from sexual activity during the study period.
- Subjects must have an IQ > 55 best tested with the HAWIK-III, alternatively with the
CFT-20 or K-ABC.
",NULL,Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ): Combined subscales Conduct Problem and Oppositional Behavior,"Assessment of the safety and tolerability by adverse event documentation.;Assessment of the efficacy by the Clinical Global Impressions-Severity of Illness scale (CGI-S) and the Global Impressions-Improvement scale (CGI-I).;Correlation between dosage, efficacy and adverse events.;Ziprasidone serum levels;Correlation between serum level, efficacy and adverse events",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-07-31,2008-05-09,2008-05-09,51,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2006,2008-11-17,TRUE,FALSE,TRUE
14859,NCT00693017,NA,NA,NCT: 2008-06-03 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,Explicitly mentioned that no AM could be conducted,NCT: Actual 10 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2008-06-06,NA,2008-06-30,NA,Interventional,Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy,"A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy",Terminated,Phase 3,10,Actual,Eisai Inc.,Number of Participants Considered Responders as Assessed During the Maintenance Period,Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures,2007-003556-10;E2090-E044-317,Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy,"A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy",;;;,;;;,Interventional,,Phase 3,2008-06-03,2008-06-20,10,Terminated,Eisai Limited,NULL,australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine;australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine;australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine;australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine;australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine;australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine;australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine;australia;croatia;czech republic;estonia;finland;germany;hungary;lithuania;poland;romania;russian federation;serbia;ukraine,Drug: Zonisamide;Drug: Placebo;Drug: Zonisamide;Drug: Placebo;Drug: Zonisamide;Drug: Placebo;Drug: Zonisamide;Drug: Placebo,"
Inclusion Criteria:
1. Subject is male or female and aged 12-65 years.
2. Subject has at least eight days with at least one myoclonic seizure over the two
months Baseline Period. Myoclonic seizures must occur in the context of IGE and may be
accompanied by other primary generalized seizures, provided these are also consistent
with a diagnosis of Idiopathic Generalized Epilepsy (IGE).
3. Subject (or parent/caregiver, for subjects below the age of consent) is willing to
sign an informed consent form. Subjects below the age of consent in their country,
must where appropriate be willing to give informed (written or verbal) assent.
Subjects from the age specified in local regulations will be required to sign an
appropriate informed consent form.
4. Subject is taking a stable regimen of one or two other AEDs for at least two weeks
prior to Visit 1 (start of the Baseline Period).
5. Subject has a clinical diagnosis of any type of idiopathic generalised epilepsy (IGE)
which has myoclonic seizures (and which may be accompanied by other generalised
seizure types), according to the International League Against Epilepsy (ILAE)
Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies
and Epileptic Syndromes (1989). Diagnosis should have been established by clinical
history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging
(CT/MRI) of the brain consistent with idiopathic generalised epilepsy. A CT/MRI scan
should have been performed within five years of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
6. EEG should have been performed within one year of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
7. Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant
or lactating, or are post-menopausal.
8. Female subjects of childbearing potential = 18 years must abide by one of the
following medically acceptable contraceptive measures: oral contraception pill,
contraceptive injections, implants or patches, intrauterine device in place for at
least three months or vasectomised partner or abstinence throughout the study.
Subjects <18 years and of childbearing potential must be either abstinent or willing
to use one of the medically appropriate forms of contraception for the duration of the
study.
Exclusion Criteria:
1. Subject has progressive or focal neurological disease (as determined by preexisting
brain imaging such as CT or MRI performed maximally five years before the screening
visit), or clinically significant organic disease.
2. Subject has a history of, or results of clinical investigations (including EEG data)
that are suggestive of, partial seizures as defined by the ILAE, including generalised
tonic clonic seizures which are suspected to be secondarily generalised.
3. Subjects with cryptogenic or symptomatic generalised epilepsy.
4. Subjects with psychogenic seizures.
5. Subject has a history of convulsive status epilepticus within a year of screening
while complying with AEDs.
6. Subject has a history of renal calculi or renal insufficiency (above the upper normal
limits of creatinine).
7. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or
C.
8. Subject has a predisposing condition that might interfere with absorption,
distribution, or excretion of zonisamide.
9. Subject has a history of sensitivity to sulfonamide drugs or to zonisamide or any of
its excipients.
10. Subject has a recent history of excessive alcohol use or drug abuse.
11. Subject has a history of suicide attempt in the five years before the screening visit.
12. Subject has abnormal screening laboratory values that are clinically significant.
13. Subject has a history of demonstrated non-compliance with treatment, or the subject or
parent/caregiver can be reasonably expected not to be compliant with study procedures
or to complete the study.
14. Subject has participated in a study of an investigational drug or device within 30
days prior to screening.
15. Subject has received previous treatment with zonisamide.
16. Subject is treated with ketogenic diet or vagus nerve stimulator.
17. Subject has a history of necessary treatment with rescue benzodiazepines which is
foreseen to continue during the study. Rescue benzodiazepines will not be allowed in
this study (stable dosing with a benzodiazepine as (one of the) baseline
anti-epileptic drug(s) is allowed).
18. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate and
drugs with anticholinergic activity.
19. Current psychosis or moderate to severe depression, or use of anti-psychotic drugs,
MAOIs, tricyclic antidepressants, benzodiazepine or barbiturate treatment for
disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days
before the screening visit.
20. Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
21. Subject is unable to swallow capsules.
22. Subject is not in general good health as determined by medical history, physical exam
and screening laboratory results.
;
Inclusion Criteria:
1. Subject is male or female and aged 12-65 years.
2. Subject has at least eight days with at least one myoclonic seizure over the two
months Baseline Period. Myoclonic seizures must occur in the context of IGE and may be
accompanied by other primary generalized seizures, provided these are also consistent
with a diagnosis of Idiopathic Generalized Epilepsy (IGE).
3. Subject (or parent/caregiver, for subjects below the age of consent) is willing to
sign an informed consent form. Subjects below the age of consent in their country,
must where appropriate be willing to give informed (written or verbal) assent.
Subjects from the age specified in local regulations will be required to sign an
appropriate informed consent form.
4. Subject is taking a stable regimen of one or two other AEDs for at least two weeks
prior to Visit 1 (start of the Baseline Period).
5. Subject has a clinical diagnosis of any type of idiopathic generalised epilepsy (IGE)
which has myoclonic seizures (and which may be accompanied by other generalised
seizure types), according to the International League Against Epilepsy (ILAE)
Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies
and Epileptic Syndromes (1989). Diagnosis should have been established by clinical
history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging
(CT/MRI) of the brain consistent with idiopathic generalised epilepsy. A CT/MRI scan
should have been performed within five years of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
6. EEG should have been performed within one year of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
7. Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant
or lactating, or are post-menopausal.
8. Female subjects of childbearing potential = 18 years must abide by one of the
following medically acceptable contraceptive measures: oral contraception pill,
contraceptive injections, implants or patches, intrauterine device in place for at
least three months or vasectomised partner or abstinence throughout the study.
Subjects <18 years and of childbearing potential must be either abstinent or willing
to use one of the medically appropriate forms of contraception for the duration of the
study.
Exclusion Criteria:
1. Subject has progressive or focal neurological disease (as determined by preexisting
brain imaging such as CT or MRI performed maximally five years before the screening
visit), or clinically significant organic disease.
2. Subject has a history of, or results of clinical investigations (including EEG data)
that are suggestive of, partial seizures as defined by the ILAE, including generalised
tonic clonic seizures which are suspected to be secondarily generalised.
3. Subjects with cryptogenic or symptomatic generalised epilepsy.
4. Subjects with psychogenic seizures.
5. Subject has a history of convulsive status epilepticus within a year of screening
while complying with AEDs.
6. Subject has a history of renal calculi or renal insufficiency (above the upper normal
limits of creatinine).
7. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or
C.
8. Subject has a predisposing condition that might interfere with absorption,
distribution, or excretion of zonisamide.
9. Subject has a history of sensitivity to sulfonamide drugs or to zonisamide or any of
its excipients.
10. Subject has a recent history of excessive alcohol use or drug abuse.
11. Subject has a history of suicide attempt in the five years before the screening visit.
12. Subject has abnormal screening laboratory values that are clinically significant.
13. Subject has a history of demonstrated non-compliance with treatment, or the subject or
parent/caregiver can be reasonably expected not to be compliant with study procedures
or to complete the study.
14. Subject has participated in a study of an investigational drug or device within 30
days prior to screening.
15. Subject has received previous treatment with zonisamide.
16. Subject is treated with ketogenic diet or vagus nerve stimulator.
17. Subject has a history of necessary treatment with rescue benzodiazepines which is
foreseen to continue during the study. Rescue benzodiazepines will not be allowed in
this study (stable dosing with a benzodiazepine as (one of the) baseline
anti-epileptic drug(s) is allowed).
18. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate and
drugs with anticholinergic activity.
19. Current psychosis or moderate to severe depression, or use of anti-psychotic drugs,
MAOIs, tricyclic antidepressants, benzodiazepine or barbiturate treatment for
disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days
before the screening visit.
20. Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
21. Subject is unable to swallow capsules.
22. Subject is not in general good health as determined by medical history, physical exam
and screening laboratory results.
;
Inclusion Criteria:
1. Subject is male or female and aged 12-65 years.
2. Subject has at least eight days with at least one myoclonic seizure over the two
months Baseline Period. Myoclonic seizures must occur in the context of IGE and may be
accompanied by other primary generalized seizures, provided these are also consistent
with a diagnosis of Idiopathic Generalized Epilepsy (IGE).
3. Subject (or parent/caregiver, for subjects below the age of consent) is willing to
sign an informed consent form. Subjects below the age of consent in their country,
must where appropriate be willing to give informed (written or verbal) assent.
Subjects from the age specified in local regulations will be required to sign an
appropriate informed consent form.
4. Subject is taking a stable regimen of one or two other AEDs for at least two weeks
prior to Visit 1 (start of the Baseline Period).
5. Subject has a clinical diagnosis of any type of idiopathic generalised epilepsy (IGE)
which has myoclonic seizures (and which may be accompanied by other generalised
seizure types), according to the International League Against Epilepsy (ILAE)
Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies
and Epileptic Syndromes (1989). Diagnosis should have been established by clinical
history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging
(CT/MRI) of the brain consistent with idiopathic generalised epilepsy. A CT/MRI scan
should have been performed within five years of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
6. EEG should have been performed within one year of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
7. Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant
or lactating, or are post-menopausal.
8. Female subjects of childbearing potential = 18 years must abide by one of the
following medically acceptable contraceptive measures: oral contraception pill,
contraceptive injections, implants or patches, intrauterine device in place for at
least three months or vasectomised partner or abstinence throughout the study.
Subjects <18 years and of childbearing potential must be either abstinent or willing
to use one of the medically appropriate forms of contraception for the duration of the
study.
Exclusion Criteria:
1. Subject has progressive or focal neurological disease (as determined by preexisting
brain imaging such as CT or MRI performed maximally five years before the screening
visit), or clinically significant organic disease.
2. Subject has a history of, or results of clinical investigations (including EEG data)
that are suggestive of, partial seizures as defined by the ILAE, including generalised
tonic clonic seizures which are suspected to be secondarily generalised.
3. Subjects with cryptogenic or symptomatic generalised epilepsy.
4. Subjects with psychogenic seizures.
5. Subject has a history of convulsive status epilepticus within a year of screening
while complying with AEDs.
6. Subject has a history of renal calculi or renal insufficiency (above the upper normal
limits of creatinine).
7. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or
C.
8. Subject has a predisposing condition that might interfere with absorption,
distribution, or excretion of zonisamide.
9. Subject has a history of sensitivity to sulfonamide drugs or to zonisamide or any of
its excipients.
10. Subject has a recent history of excessive alcohol use or drug abuse.
11. Subject has a history of suicide attempt in the five years before the screening visit.
12. Subject has abnormal screening laboratory values that are clinically significant.
13. Subject has a history of demonstrated non-compliance with treatment, or the subject or
parent/caregiver can be reasonably expected not to be compliant with study procedures
or to complete the study.
14. Subject has participated in a study of an investigational drug or device within 30
days prior to screening.
15. Subject has received previous treatment with zonisamide.
16. Subject is treated with ketogenic diet or vagus nerve stimulator.
17. Subject has a history of necessary treatment with rescue benzodiazepines which is
foreseen to continue during the study. Rescue benzodiazepines will not be allowed in
this study (stable dosing with a benzodiazepine as (one of the) baseline
anti-epileptic drug(s) is allowed).
18. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate and
drugs with anticholinergic activity.
19. Current psychosis or moderate to severe depression, or use of anti-psychotic drugs,
MAOIs, tricyclic antidepressants, benzodiazepine or barbiturate treatment for
disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days
before the screening visit.
20. Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
21. Subject is unable to swallow capsules.
22. Subject is not in general good health as determined by medical history, physical exam
and screening laboratory results.
;
Inclusion Criteria:
1. Subject is male or female and aged 12-65 years.
2. Subject has at least eight days with at least one myoclonic seizure over the two
months Baseline Period. Myoclonic seizures must occur in the context of IGE and may be
accompanied by other primary generalized seizures, provided these are also consistent
with a diagnosis of Idiopathic Generalized Epilepsy (IGE).
3. Subject (or parent/caregiver, for subjects below the age of consent) is willing to
sign an informed consent form. Subjects below the age of consent in their country,
must where appropriate be willing to give informed (written or verbal) assent.
Subjects from the age specified in local regulations will be required to sign an
appropriate informed consent form.
4. Subject is taking a stable regimen of one or two other AEDs for at least two weeks
prior to Visit 1 (start of the Baseline Period).
5. Subject has a clinical diagnosis of any type of idiopathic generalised epilepsy (IGE)
which has myoclonic seizures (and which may be accompanied by other generalised
seizure types), according to the International League Against Epilepsy (ILAE)
Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies
and Epileptic Syndromes (1989). Diagnosis should have been established by clinical
history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging
(CT/MRI) of the brain consistent with idiopathic generalised epilepsy. A CT/MRI scan
should have been performed within five years of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
6. EEG should have been performed within one year of the screening visit or, if not
available from this period, should be performed in the Baseline Period.
7. Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant
or lactating, or are post-menopausal.
8. Female subjects of childbearing potential = 18 years must abide by one of the
following medically acceptable contraceptive measures: oral contraception pill,
contraceptive injections, implants or patches, intrauterine device in place for at
least three months or vasectomised partner or abstinence throughout the study.
Subjects <18 years and of childbearing potential must be either abstinent or willing
to use one of the medically appropriate forms of contraception for the duration of the
study.
Exclusion Criteria:
1. Subject has progressive or focal neurological disease (as determined by preexisting
brain imaging such as CT or MRI performed maximally five years before the screening
visit), or clinically significant organic disease.
2. Subject has a history of, or results of clinical investigations (including EEG data)
that are suggestive of, partial seizures as defined by the ILAE, including generalised
tonic clonic seizures which are suspected to be secondarily generalised.
3. Subjects with cryptogenic or symptomatic generalised epilepsy.
4. Subjects with psychogenic seizures.
5. Subject has a history of convulsive status epilepticus within a year of screening
while complying with AEDs.
6. Subject has a history of renal calculi or renal insufficiency (above the upper normal
limits of creatinine).
7. Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or
C.
8. Subject has a predisposing condition that might interfere with absorption,
distribution, or excretion of zonisamide.
9. Subject has a history of sensitivity to sulfonamide drugs or to zonisamide or any of
its excipients.
10. Subject has a recent history of excessive alcohol use or drug abuse.
11. Subject has a history of suicide attempt in the five years before the screening visit.
12. Subject has abnormal screening laboratory values that are clinically significant.
13. Subject has a history of demonstrated non-compliance with treatment, or the subject or
parent/caregiver can be reasonably expected not to be compliant with study procedures
or to complete the study.
14. Subject has participated in a study of an investigational drug or device within 30
days prior to screening.
15. Subject has received previous treatment with zonisamide.
16. Subject is treated with ketogenic diet or vagus nerve stimulator.
17. Subject has a history of necessary treatment with rescue benzodiazepines which is
foreseen to continue during the study. Rescue benzodiazepines will not be allowed in
this study (stable dosing with a benzodiazepine as (one of the) baseline
anti-epileptic drug(s) is allowed).
18. Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate and
drugs with anticholinergic activity.
19. Current psychosis or moderate to severe depression, or use of anti-psychotic drugs,
MAOIs, tricyclic antidepressants, benzodiazepine or barbiturate treatment for
disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days
before the screening visit.
20. Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
21. Subject is unable to swallow capsules.
22. Subject is not in general good health as determined by medical history, physical exam
and screening laboratory results.
",NULL,Number of Participants Considered Responders as Assessed During the Maintenance Period;Number of Participants Considered Responders as Assessed During the Maintenance Period,Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-06-30,2008-06-03,2008-06-03,10,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2008,2015-12-21,TRUE,FALSE,TRUE
18608,NCT00006251,NA,NCT00006251,NCT: 2000-09-11 ICTRP: 2000-09-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no AM,NA,NA,NA,NCT: Actual 21 ICTRP: 21 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2004-06-09,NA,2000-05-31,NA,Interventional,"Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer","Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil",Completed,Phase 1/Phase 2,21,Actual,Fred Hutchinson Cancer Research Center,Risk of graft rejection defined as the absence of detectable peripheral blood donor T cells with the addition of fludarabine phosphate;Incidence of acute grade II/IV GVHD;Incidence of chronic GVHD,"Incidence of myelosuppression (ANC < 500/ul for > 2 days, platelets < 20,000/ul for > 2 days) after initial PBSC infusion;Response of malignancy to DLI;Incidence of aplasia after DLI;Dose of CD3+ cells required to convert mixed to full lymphoid chimeras;Incidence of non-relapse mortality",NCI-2013-01634;1533.00;P01CA078902;P30CA015704;1533.00,"Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic Cancer","Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil",,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1/Phase 2,2000-09-11,2000-05-20,21,Completed,Fred Hutchinson Cancer Research Center,National Cancer Institute (NCI),united states;italy;united states;germany,Radiation: total-body irradiation;Drug: fludarabine phosphate;Drug: cyclosporine;Drug: mycophenolate mofetil;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Biological: donor lymphocytes;Procedure: peripheral blood stem cell transplantation;Other: laboratory biomarker analysis,"
Inclusion Criteria:
- Patients aged > 49 years and < 75 years with non-Hodgkin lymphoma (NHL), chronic
lymphocytic leukemia (CLL) and multiple myeloma who are not eligible for a curative
autologous transplantation or who have failed prior autologous transplantation;
patients with NHL and CLL must have failed prior therapy with an alkylating agent
and/or fludarabine, or be at high risk of relapse; patients with multiple myeloma must
have stage II or III disease and received prior chemotherapy
- Patients < 50 years of age with NHL, CLL or multiple myeloma at high risk of regimen
related toxicity through prior autologous transplant or through pre-existing medical
conditions
- Patients < 75 years of age with other malignant diseases treatable by allogeneic bone
marrow transplant (BMT) whom through pre-existing chronic disease affecting kidneys,
liver, lungs, and heart are considered to be at high risk for regimen related toxicity
using standard high dose regimens; the following diseases are the likely candidates:
- Myelodysplastic syndromes
- Myeloproliferative syndromes
- Acute Leukemia with < 10% blasts
- Amyloidosis
- Hodgkin's disease
- Renal cell carcinoma
- Patients with other malignancies declining standard allografts may be approved for
transplant following presentation and approval by the Fred Hutchinson Cancer Research
Center (FHCRC) chimerism group
- DONOR:
- Human leukocyte antigen (HLA) genotypically or phenotypically identical related
donor
- Donor must consent to granulocyte colony-stimulating factor (G-CSF)
administration and leukopheresis
- Donor must have adequate veins for leukopheresis or agree to placement of central
venous catheter (femoral, subclavian)
- Age < 75 years
Exclusion Criteria:
- Eligible for a high-priority curative autologous transplant
- Patients with rapidly progressive aggressive NHL unless in minimal disease state
- Active central nervous system (CNS) involvement with disease
- Fertile men or women unwilling to use contraceptive techniques during and for 12
months following treatment
- Females who are pregnant
- Patients who are human immunodeficiency virus (HIV) positive
- Cardiac ejection fraction < 40%
- Severe defects in pulmonary function testing (defects are currently categorized as
mild, moderate and severe) as defined by the pulmonary consultant, or receiving
supplementary continuous oxygen
- Total bilirubin > 2 x the upper limit of normal
- Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic
transaminase (SGOT) 4 x the upper limit of normal
- Karnofsky score < 50
- Patients with poorly controlled hypertension
- Patients with renal failure are eligible, however patients with renal compromise
(serum creatinine greater than 2.0) will likely have further compromise in renal
function and may require hemodialysis (which may be permanent) due to the need to
maintain adequate serum cyclosporine levels
- DONOR:
- Identical twin
- Age less than 12 years
- Pregnancy
- Infection with HIV
- Inability to achieve adequate venous access
- Known allergy to G-CSF
- Current serious systemic illness
",NULL,Risk of graft rejection defined as the absence of detectable peripheral blood donor T cells with the addition of fludarabine phosphate;Incidence of acute grade II/IV GVHD;Incidence of chronic GVHD,"Incidence of myelosuppression (ANC < 500/ul for > 2 days, platelets < 20,000/ul for > 2 days) after initial PBSC infusion;Response of malignancy to DLI;Incidence of aplasia after DLI;Dose of CD3+ cells required to convert mixed to full lymphoid chimeras;Incidence of non-relapse mortality",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-05-31,2000-09-11,2000-09-11,21,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2000,2020-01-17,TRUE,FALSE,FALSE
9439,NCT01587898,NA,NCT01587898,NCT: 2012-04-19 ICTRP: 2012-04-19 DRKS: NA,1,1,NA,2,1,r,Criteria more specific in register,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 72 ICTRP: 72 DRKS: NA,73,1,1,NA,NA,NA,"Double (Participant, Investigator)","""blinded""",no_info,1,NA,ganzer Artikel,https://doi.org/10.1681/asn.2014111139,2014-11-25,2012-04-30,NA,2012-05-17,2013-05-07,Interventional,4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis,"A Four-week Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Recombinant Human Erythropoietin and Are Not Undergoing Dialysis",Completed,Phase 2,72,Actual,GlaxoSmithKline,Modeled Hgb Change From Baseline Over 4 Weeks of Treatment,"Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6;Model-Adjusted Maximum Hgb Changes Over 4 Weeks;Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb;Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb;Number of Participants Who Reached Hgb Stopping Criteria;Change From Baseline in Hepcidin at Week 2 and Week 4;Change From Baseline in Ferritin at Week 2 and Week 4;Change From Baseline in Transferrin at Week 2 and Week 4;Change From Baseline in Transferrin Saturation at Week 2 and Week 4;Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4;Change From Baseline in Total Iron at Week 2 and Week 4;Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4;Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks;Change From Baseline in Erythropoietin at Week 2 and Week 4;Change From Baseline in Red Blood Cells Count Over 4 Weeks;Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4;Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6;Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Participants Discontinuing the Study Treatment Due to AEs;Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6;Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6;Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6;Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6;Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6;Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6;Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6;Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6;Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6;Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6;Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6;Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6;Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6;Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6;Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6;Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6;Change From Baseline in ECG Parameters at Week 2, 4 and 6;Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites;Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites",116581,4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis,"A Four-week Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Recombinant Human Erythropoietin and Are Not Undergoing Dialysis",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2012-04-19,2012-05-17,72,Completed,GlaxoSmithKline,PPD,united states;canada;germany;canada;germany;united states;united states;canada;germany;canada;germany;united states;united states;canada;germany;canada;germany;united states;united states;canada;germany;canada;germany;united states;united states;canada;germany;canada;germany;united states,Drug: GSK1278863;Other: Placebo;Drug: GSK1278863;Other: Placebo;Drug: GSK1278863;Other: Placebo;Drug: GSK1278863;Other: Placebo,"
Inclusion Criteria:
1. Age and weight: >/= 18 years of age and >/= 45 kg.
2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or
peritoneal dialysis) or dialysis planned during the time the subject would be enrolled
in the study.
3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their
biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),
peginesatide or their biosimilars..
4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal
Disease (MDRD).
5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.
6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).
7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.
8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.
9. TSAT within the reference range.
10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if
required, that will be maintained throughout the study. NOTE: IV iron replacement
therapy is not allowed the two weeks prior to Screening through the end of the study
(Week 6).
11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at
Screening Visit, based on Central Reader's interpretation.
12. Females: Eligible to participate if she is of childbearing potential, and must agree
to use approved contraception methods from Screening until completion of the Follow-up
Visit OR of non-childbearing potential defined as pre-menopausal females with a
documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of
spontaneous amenorrhea [in questionable cases a blood sample with simultaneous
follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].
Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will
be required to use one of the approved contraception methods if they wish to continue
their HRT during the study. Otherwise they must discontinue HRT to allow confirmation
of post-menopausal status prior to study enrollment. For most types of HRT, at least 2
weeks will elapse between the cessation of therapy and the blood draw; this interval
depends on the type and dosage of HRT. Following confirmation of their post-menopausal
status, they can resume use of HRT during the study without use of a contraceptive
method.
13. Males: Must agree to use approved contraceptive methods from the time of Screening
until completion of the Follow-up Visit.
Exclusion Criteria:
1. Dialysis: Planning to initiate dialysis during the study or who have a high potential
for initiating dialysis during study participation.
2. Renal transplant: Renal transplant anticipated or scheduled within the study time
period or subjects with a functioning renal transplant.
3. Total CPK: >5x the upper limit of the reference range.
4. HIV: Positive HIV antibody.
5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.
6. History of stroke or TIAs.
7. Heart failure: Class III/IV heart failure, as defined by the New York Heart
Association (NYHA) functional classification system.
8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or
lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.
9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as
deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset
or worsening limb ischemia requiring intervention), or other thrombosis related
condition) within the prior 6 months.
10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than
normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,
significant heart failure or lung disease requiring supplemental oxygen, or those with
connective tissue diseases).
11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis
(e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac
disease).
12. Hematological disease: Any hematological disease including those affecting platelets,
the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.
sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,
hemolytic anemia) or any other cause of anemia other than renal disease.
13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the
exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening
of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit
of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that
in the opinion of the investigator would preclude the subject from participation in
the study.
14. Major surgery: Within the prior 12 weeks or planned during the study.
15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for
blood transfusion during the study.
16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer
disease or active GI bleeding within the prior 12 weeks.
17. Acute infection: Clinical evidence of acute infection or history of infection
requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening
through Day 1 (randomization).
18. Malignancy: History of malignancy within 5 years of Screening or are receiving
treatment for cancer or those with a strong family history of cancer (e.g., familial
cancer disorders), with the exception of squamous cell or basal cell carcinoma of the
skin that has been definitively treated.
19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the
Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.
20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12
months, or macular edema requiring treatment.
21. Severe reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product.
22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary
supplements that are prohibited from Screening until the Follow-up Visit.
23. Androgens: New androgen therapy or changes to pr;
Inclusion Criteria:
1. Age and weight: >/= 18 years of age and >/= 45 kg.
2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or
peritoneal dialysis) or dialysis planned during the time the subject would be enrolled
in the study.
3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their
biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),
peginesatide or their biosimilars..
4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal
Disease (MDRD).
5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.
6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).
7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.
8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.
9. TSAT within the reference range.
10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if
required, that will be maintained throughout the study. NOTE: IV iron replacement
therapy is not allowed the two weeks prior to Screening through the end of the study
(Week 6).
11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at
Screening Visit, based on Central Reader's interpretation.
12. Females: Eligible to participate if she is of childbearing potential, and must agree
to use approved contraception methods from Screening until completion of the Follow-up
Visit OR of non-childbearing potential defined as pre-menopausal females with a
documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of
spontaneous amenorrhea [in questionable cases a blood sample with simultaneous
follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].
Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will
be required to use one of the approved contraception methods if they wish to continue
their HRT during the study. Otherwise they must discontinue HRT to allow confirmation
of post-menopausal status prior to study enrollment. For most types of HRT, at least 2
weeks will elapse between the cessation of therapy and the blood draw; this interval
depends on the type and dosage of HRT. Following confirmation of their post-menopausal
status, they can resume use of HRT during the study without use of a contraceptive
method.
13. Males: Must agree to use approved contraceptive methods from the time of Screening
until completion of the Follow-up Visit.
Exclusion Criteria:
1. Dialysis: Planning to initiate dialysis during the study or who have a high potential
for initiating dialysis during study participation.
2. Renal transplant: Renal transplant anticipated or scheduled within the study time
period or subjects with a functioning renal transplant.
3. Total CPK: >5x the upper limit of the reference range.
4. HIV: Positive HIV antibody.
5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.
6. History of stroke or TIAs.
7. Heart failure: Class III/IV heart failure, as defined by the New York Heart
Association (NYHA) functional classification system.
8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or
lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.
9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as
deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset
or worsening limb ischemia requiring intervention), or other thrombosis related
condition) within the prior 6 months.
10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than
normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,
significant heart failure or lung disease requiring supplemental oxygen, or those with
connective tissue diseases).
11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis
(e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac
disease).
12. Hematological disease: Any hematological disease including those affecting platelets,
the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.
sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,
hemolytic anemia) or any other cause of anemia other than renal disease.
13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the
exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening
of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit
of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that
in the opinion of the investigator would preclude the subject from participation in
the study.
14. Major surgery: Within the prior 12 weeks or planned during the study.
15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for
blood transfusion during the study.
16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer
disease or active GI bleeding within the prior 12 weeks.
17. Acute infection: Clinical evidence of acute infection or history of infection
requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening
through Day 1 (randomization).
18. Malignancy: History of malignancy within 5 years of Screening or are receiving
treatment for cancer or those with a strong family history of cancer (e.g., familial
cancer disorders), with the exception of squamous cell or basal cell carcinoma of the
skin that has been definitively treated.
19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the
Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.
20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12
months, or macular edema requiring treatment.
21. Severe reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product.
22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary
supplements that are prohibited from Screening until the Follow-up Visit.
23. Androgens: New androgen therapy or changes to pr;
Inclusion Criteria:
1. Age and weight: >/= 18 years of age and >/= 45 kg.
2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or
peritoneal dialysis) or dialysis planned during the time the subject would be enrolled
in the study.
3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their
biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),
peginesatide or their biosimilars..
4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal
Disease (MDRD).
5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.
6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).
7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.
8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.
9. TSAT within the reference range.
10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if
required, that will be maintained throughout the study. NOTE: IV iron replacement
therapy is not allowed the two weeks prior to Screening through the end of the study
(Week 6).
11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at
Screening Visit, based on Central Reader's interpretation.
12. Females: Eligible to participate if she is of childbearing potential, and must agree
to use approved contraception methods from Screening until completion of the Follow-up
Visit OR of non-childbearing potential defined as pre-menopausal females with a
documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of
spontaneous amenorrhea [in questionable cases a blood sample with simultaneous
follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].
Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will
be required to use one of the approved contraception methods if they wish to continue
their HRT during the study. Otherwise they must discontinue HRT to allow confirmation
of post-menopausal status prior to study enrollment. For most types of HRT, at least 2
weeks will elapse between the cessation of therapy and the blood draw; this interval
depends on the type and dosage of HRT. Following confirmation of their post-menopausal
status, they can resume use of HRT during the study without use of a contraceptive
method.
13. Males: Must agree to use approved contraceptive methods from the time of Screening
until completion of the Follow-up Visit.
Exclusion Criteria:
1. Dialysis: Planning to initiate dialysis during the study or who have a high potential
for initiating dialysis during study participation.
2. Renal transplant: Renal transplant anticipated or scheduled within the study time
period or subjects with a functioning renal transplant.
3. Total CPK: >5x the upper limit of the reference range.
4. HIV: Positive HIV antibody.
5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.
6. History of stroke or TIAs.
7. Heart failure: Class III/IV heart failure, as defined by the New York Heart
Association (NYHA) functional classification system.
8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or
lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.
9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as
deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset
or worsening limb ischemia requiring intervention), or other thrombosis related
condition) within the prior 6 months.
10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than
normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,
significant heart failure or lung disease requiring supplemental oxygen, or those with
connective tissue diseases).
11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis
(e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac
disease).
12. Hematological disease: Any hematological disease including those affecting platelets,
the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.
sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,
hemolytic anemia) or any other cause of anemia other than renal disease.
13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the
exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening
of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit
of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that
in the opinion of the investigator would preclude the subject from participation in
the study.
14. Major surgery: Within the prior 12 weeks or planned during the study.
15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for
blood transfusion during the study.
16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer
disease or active GI bleeding within the prior 12 weeks.
17. Acute infection: Clinical evidence of acute infection or history of infection
requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening
through Day 1 (randomization).
18. Malignancy: History of malignancy within 5 years of Screening or are receiving
treatment for cancer or those with a strong family history of cancer (e.g., familial
cancer disorders), with the exception of squamous cell or basal cell carcinoma of the
skin that has been definitively treated.
19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the
Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.
20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12
months, or macular edema requiring treatment.
21. Severe reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product.
22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary
supplements that are prohibited from Screening until the Follow-up Visit.
23. Androgens: New androgen therapy or changes to pr;
Inclusion Criteria:
1. Age and weight: >/= 18 years of age and >/= 45 kg.
2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or
peritoneal dialysis) or dialysis planned during the time the subject would be enrolled
in the study.
3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their
biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta),
peginesatide or their biosimilars..
4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal
Disease (MDRD).
5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.
6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).
7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.
8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.
9. TSAT within the reference range.
10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if
required, that will be maintained throughout the study. NOTE: IV iron replacement
therapy is not allowed the two weeks prior to Screening through the end of the study
(Week 6).
11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at
Screening Visit, based on Central Reader's interpretation.
12. Females: Eligible to participate if she is of childbearing potential, and must agree
to use approved contraception methods from Screening until completion of the Follow-up
Visit OR of non-childbearing potential defined as pre-menopausal females with a
documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of
spontaneous amenorrhea [in questionable cases a blood sample with simultaneous
follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory].
Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will
be required to use one of the approved contraception methods if they wish to continue
their HRT during the study. Otherwise they must discontinue HRT to allow confirmation
of post-menopausal status prior to study enrollment. For most types of HRT, at least 2
weeks will elapse between the cessation of therapy and the blood draw; this interval
depends on the type and dosage of HRT. Following confirmation of their post-menopausal
status, they can resume use of HRT during the study without use of a contraceptive
method.
13. Males: Must agree to use approved contraceptive methods from the time of Screening
until completion of the Follow-up Visit.
Exclusion Criteria:
1. Dialysis: Planning to initiate dialysis during the study or who have a high potential
for initiating dialysis during study participation.
2. Renal transplant: Renal transplant anticipated or scheduled within the study time
period or subjects with a functioning renal transplant.
3. Total CPK: >5x the upper limit of the reference range.
4. HIV: Positive HIV antibody.
5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.
6. History of stroke or TIAs.
7. Heart failure: Class III/IV heart failure, as defined by the New York Heart
Association (NYHA) functional classification system.
8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or
lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.
9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as
deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset
or worsening limb ischemia requiring intervention), or other thrombosis related
condition) within the prior 6 months.
10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than
normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g.,
significant heart failure or lung disease requiring supplemental oxygen, or those with
connective tissue diseases).
11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis
(e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac
disease).
12. Hematological disease: Any hematological disease including those affecting platelets,
the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g.
sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma,
hemolytic anemia) or any other cause of anemia other than renal disease.
13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the
exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening
of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit
of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that
in the opinion of the investigator would preclude the subject from participation in
the study.
14. Major surgery: Within the prior 12 weeks or planned during the study.
15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for
blood transfusion during the study.
16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer
disease or active GI bleeding within the prior 12 weeks.
17. Acute infection: Clinical evidence of acute infection or history of infection
requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening
through Day 1 (randomization).
18. Malignancy: History of malignancy within 5 years of Screening or are receiving
treatment for cancer or those with a strong family history of cancer (e.g., familial
cancer disorders), with the exception of squamous cell or basal cell carcinoma of the
skin that has been definitively treated.
19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the
Investigator, including subjects with parathyroid hormone (PTH) values =600 pg/mL.
20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12
months, or macular edema requiring treatment.
21. Severe reactions: History of severe allergic or anaphylactic reactions or
hypersensitivity to excipients in the investigational product.
22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary
supplements that are prohibited from Screening until the Follow-up Visit.
23. Androgens: New androgen therapy or changes to pr",NULL,Modeled Hgb Change From Baseline Over 4 Weeks of Treatment;Modeled Hgb Change From Baseline Over 4 Weeks of Treatment;Modeled Hgb Change From Baseline Over 4 Weeks of Treatment,"Model-Adjusted Maximum Hgb Changes Over 4 Weeks;Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb;Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb;Number of Participants Who Reached Hgb Stopping Criteria;Change From Baseline in Hepcidin at Week 2 and Week 4;Change From Baseline in Ferritin at Week 2 and Week 4;Change From Baseline in Transferrin at Week 2 and Week 4;Change From Baseline in Transferrin Saturation at Week 2 and Week 4;Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4;Change From Baseline in Total Iron at Week 2 and Week 4;Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4;Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks;Change From Baseline in Erythropoietin at Week 2 and Week 4;Change From Baseline in Red Blood Cells Count Over 4 Weeks;Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4;Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Participants Discontinuing the Study Treatment Due to AEs;Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6;Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6;Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6;Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6;Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6;Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6;Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6;Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6;Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6;Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6;Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6;Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6;Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6;Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6;Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6;Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6;Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6;Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6;Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6;Change From Baseline in ECG Parameters at Week 2, 4 and 6;Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites;Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-05-17,2012-04-19,2012-04-19,72,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,2017-10-09,TRUE,FALSE,FALSE
18965,NCT03182907,NA,NCT03182907,NCT: 2017-06-08 ICTRP: 2017-06-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Anticipated 192 ICTRP: 192 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-06-09,NA,2018-03-27,2022-05-09,Interventional,Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001),"A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK-6072, Human Monoclonal Antibody to C. Difficile Toxin B) in Children Aged 1 to <18 Years Receiving Antibacterial Drug Treatment for C. Difficile Infection (MODIFY III)",Recruiting,Phase 3,192,Anticipated,Merck Sharp & Dohme Corp.,Concentration time curve of bezlotoxumab;Adverse events (AEs);Discontinuing medication,Clostridium difficile infection (CDI) recurrence;Sustained clinical response;CDI recurrence and sustained clinical response;Infusion-related reactions;Positive antibodies to bezlotoxumab,2017-000070-11;6072-001,Bezlotoxumab (MK-6072) Versus Placebo in Children With Clostridium Difficile Infection (CDI) (MK-6072-001),"A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Infusion of Bezlotoxumab (MK-6072, Human Monoclonal Antibody to C. Difficile Toxin B) in Children Aged 1 to <18 Years Receiving Antibacterial Drug Treatment for C. Difficile Infection (MODIFY III)",;Trialsites@merck.com,;Trialsites@merck.com,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 3,2017-06-08,2018-03-27,192,Recruiting,Merck Sharp & Dohme Corp.,NULL,united states;argentina;brazil;colombia;czechia;germany;hungary;malaysia;mexico;norway;poland;portugal;romania;south africa;spain;sweden;united kingdom;argentina;brazil;colombia;czechia;germany;hungary;malaysia;mexico;norway;poland;portugal;romania;south africa;spain;sweden;united kingdom;united states,Biological: Bezlotoxumab;Drug: Placebo,"
Inclusion Criteria:
- At screening has suspected or confirmed CDI, and is receiving or is planning to
receive a 10- to 21-day course of antibacterial drug treatment for CDI
- At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects
the presence of C. difficile toxin in stool, and is still receiving antibacterial drug
treatment for CDI.
- Female is not pregnant, and not breastfeeding; but if of childbearing potential agrees
to follow contraceptive guidance during the treatment period and for at least 12 weeks
after the last dose of study treatment
- Participant and/or parent or caregiver must be able to read, understand, and complete
the daily diary
Exclusion Criteria:
- Has an uncontrolled chronic diarrheal illness
- Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its
excipients
- At randomization, their planned course of antibacterial drug treatment for CDI is
longer than 21 days
- At screening has received any listed prohibited prior and concomitant treatments and
procedures
- Has previously participated in this study, has previously received bezlotoxumab, has
received an experimental monoclonal antibody against C. difficile toxin B, or has
received a vaccine directed against C. difficile or its toxins.
- Has received an investigational study agent within the previous 30 days, or is
currently participating in or scheduled to participate in any other clinical study
with an investigational agent during the 12-week study period
",NULL,Concentration time curve of bezlotoxumab;Adverse events (AEs);Discontinuing medication,Positive antibodies to bezlotoxumab;Infusion-related reactions;CDI recurrence and sustained clinical response;Sustained clinical response;Clostridium difficile infection (CDI) recurrence,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-03-27,2017-06-08,2017-06-08,192,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-12-30,TRUE,FALSE,TRUE
16548,NCT00412061,NA,NA,NCT: 2006-12-13 ICTRP: NA DRKS: NA,1,1,NA,1,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 429 ICTRP: NA DRKS: NA,429,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,0,no outcome,ganzer Artikel,https://doi.org/10.1016/s0140-6736(11)61742-x,2011-11-25,2006-12-15,NA,2006-12-31,2013-06-30,Interventional,Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor,"A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo",Completed,Phase 3,429,Actual,Novartis,Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review,"Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST);Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level;Overall Survival Using Kaplan-Meier Methodology;Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase);Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase);Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)",2006-004507-18;CRAD001C2325,Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor,"A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo",;;;,;;;,Interventional,,Phase 3,2006-12-13,2006-12-20,429,Completed,Novartis Pharmaceuticals,NULL,united states;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;united states;united states;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;united states;united states;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;united states;united states;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;australia;belgium;canada;czech republic;finland;france;germany;greece;italy;netherlands;slovakia;spain;sweden;united kingdom;united states,Drug: Octreotide;Drug: Placebo;Drug: Everolimus;Drug: Octreotide;Drug: Placebo;Drug: Everolimus;Drug: Octreotide;Drug: Placebo;Drug: Everolimus;Drug: Octreotide;Drug: Placebo;Drug: Everolimus,"
Inclusion criteria:
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic
resonance imaging (MRI).
Exclusion criteria:
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic
metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus,
temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
- Chronic treatment with corticosteroids or other immunosuppressive agent.
- Other primary cancer within 3 years.
Other protocol-defined inclusion/exclusion criteria applied
;
Inclusion criteria:
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic
resonance imaging (MRI).
Exclusion criteria:
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic
metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus,
temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
- Chronic treatment with corticosteroids or other immunosuppressive agent.
- Other primary cancer within 3 years.
Other protocol-defined inclusion/exclusion criteria applied
;
Inclusion criteria:
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic
resonance imaging (MRI).
Exclusion criteria:
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic
metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus,
temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
- Chronic treatment with corticosteroids or other immunosuppressive agent.
- Other primary cancer within 3 years.
Other protocol-defined inclusion/exclusion criteria applied
;
Inclusion criteria:
- Advanced (unresectable or metastatic) carcinoid tumor
- Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Documented progression of disease within 12 months prior to randomization.
- Measurable disease determined by triphasic computer tomography (CT) scan or magnetic
resonance imaging (MRI).
Exclusion criteria:
- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
- Hepatic artery embolization within the last 6 months or cryoablation of hepatic
metastasis within 2 months of enrollment.
- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus,
temsirolimus, everolimus)
- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
- Severe or uncontrolled medical conditions
- Chronic treatment with corticosteroids or other immunosuppressive agent.
- Other primary cancer within 3 years.
Other protocol-defined inclusion/exclusion criteria applied
",NULL,Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review;Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review,"Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST);Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level;Overall Survival Using Kaplan-Meier Methodology;Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase);Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase);Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-12-31,2006-12-13,2006-12-13,429,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2006,2014-11-11,TRUE,FALSE,TRUE
11495,NCT01257425,NA,NA,NCT: 2010-12-08 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 109 ICTRP: NA DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2010-12-09,NA,2010-12-31,2012-05-31,Interventional,Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg,"A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer",Completed,Phase 2,109,Actual,Ipsen,Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).,Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d);Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d);Maximum Concentration of Serum Testosterone [Cmax] - Raw Data;Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data;Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL;Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL,2010-019632-12;A-94-52014-178,Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg,"A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2010-12-08,2010-12-20,109,Completed,Ipsen,NULL,germany,Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg),"
Inclusion Criteria:
- Histologically or cytologically proven prostate cancer, locally advanced or
metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and
the patient scheduled to receive androgen deprivation therapy
- Serum testosterone levels = 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured
by any laboratory or on site within the previous 6 months or at study start
- Karnofsky performance index > 70
- Expected survival = 9 months
Exclusion Criteria:
- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone
(GnRH) agonists or antagonists within the last 12 months preceding the study or
concomitant treatment with one or more of these substance(s)
- Any current use or within 6 months prior to treatment start of medications which are
known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole,
aminoglutethimide, oestrogens and progesterone
- Patient at risk of spinal cord compression or ureter obstruction
- Prior hypophysectomy or adrenalectomy
",NULL,Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).,Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d);Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d);Maximum Concentration of Serum Testosterone [Cmax] - Raw Data;Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data;Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL;Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL,2010-019632-12; NCT01257425; A-94-52014-178; 2010-019632-12,2012-10-17,no,Prostate Cancer; Malignant neoplasm of prostate,Arm 1 Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg),Interventional,Randomized controlled trial,Open (masking not used),Other,Parallel,II,"- Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).; time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose; Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
","- Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d); time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose; Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
- Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d); time frame: 85, 87, 113, 141 and 169 days post-dose; Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
- Maximum Concentration of Serum Testosterone [Cmax] - Raw Data; time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose; Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
- Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data; time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose; Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
- Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL; time frame: 12 weeks; tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.
- Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL; time frame: 12 weeks; tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.
",Germany,[---]* Bad Bergzabern; [---]* Bad Ems; [---]* Bamberg; [---]* Berlin; [---]* Braunschweig; [---]* Cham; [---]* Chemnitz; [---]* Dessau; [---]* Freiburg; [---]* Gelsenkirchen; [---]* Herzberg; [---]* Lutherstadt Eisleben; [---]* Marburg; [---]* Markkleeberg; [---]* Miltenberg; [---]* Mülheim; [---]* München; [---]* Neunkirchen; [---]* Neunkirchen; [---]* Reutlingen,2010-12-31,NA,102,2012-05-01,"- Histologically or cytologically proven prostate cancer, locally advanced or
metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and
the patient scheduled to receive androgen deprivation therapy
- Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l)
measured by any laboratory or on site within the previous 6 months or at study start
- Karnofsky performance index > 70
- Expected survival ≥ 9 months
","- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone
(GnRH) agonists or antagonists within the last 12 months preceding the study or
concomitant treatment with one or more of these substance(s)
- Any current use or within 6 months prior to treatment start of medications which are
known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole,
aminoglutethimide, oestrogens and progesterone
- Patient at risk of spinal cord compression or ureter obstruction
- Prior hypophysectomy or adrenalectomy
","A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer","Recruiting complete, follow-up complete",Ipsen; Ipsen; Ipsen,[---]*; [---]*; [---]*,Arm 1 Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg),2010-12-31,2010-12-08,2010-12-08,109,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2010,2019-01-24,TRUE,TRUE,TRUE
10300,NCT01442376,NA,EUCTR2010-022872-30,NCT: 2011-09-21 ICTRP: 2010-12-22 DRKS: NA,1,1,NA,2,1,r,Criteria more specific in register,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 502 ICTRP: 492 DRKS: NA,502,1,1,2,1,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Called ""Double-blind"" but may be quadruple blind based on described details",ok,1,NA,ganzer Artikel,https://doi.org/10.1016/s1470-2045(15)00520-3,NA,2011-09-28,NA,2011-09-30,2012-11-30,Interventional,Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients,"A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC",Completed,Phase 3,502,Actual,Helsinn Healthcare SA,Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1,Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1,PALO-10-20,Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients,"A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC",NULL,NULL,Interventional,,Phase 3,2011-09-21,2011-09-20,502,Completed,Helsinn Healthcare SA,NULL,united states;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;united states;united states;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;united states;united states;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;united states;united states;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;argentina;austria;bulgaria;chile;czech republic;estonia;france;germany;hungary;peru;poland;romania;russian federation;serbia;ukraine;united states,Drug: Palonosetron;Drug: Palonosetron;Drug: Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Palonosetron;Drug: Palonosetron;Drug: Palonosetron;Drug: Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Palonosetron;Drug: Palonosetron;Drug: Palonosetron;Drug: Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Palonosetron;Drug: Palonosetron;Drug: Palonosetron;Drug: Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Ondansetron;Drug: Placebo to Palonosetron,"
Inclusion Criteria:
- Written informed consent signed by parent(s)/legal guardians of the pediatric patient
in compliance with the local laws and regulations. In addition signed children's
assent form according to local requirements
- Male or female in- or out-patients from neonates (full term) to <17 years at the time
of randomization
- Patient weight at least 3.2 kg
- Histologically, and/or cytologically (or imaging in the case of brain tumors)
confirmed malignant disease
- Naïve or non-naïve to chemotherapy
- Scheduled and eligible to receive at least one of the moderately or highly emetogenic
chemotherapeutic agents on Study Day 1
- For patients aged = 10 years to <17 years: ECOG PS = 2
- For patients with known hepatic impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known renal impairment: in the Investigator's opinion the impairment
should not jeopardize patient's safety during the study
- For patients with known history or predisposition to cardiac abnormalities: in the
Investigator's opinion the history/predisposition should not jeopardize patient's
safety during the study
- For patients with known clinically relevant abnormal laboratory values: in the
Investigator's opinion the abnormality should not jeopardize the patient's safety
during the study
- Fertile patients (male or female) must use reliable contraceptive measures
- Female patients who have attained menarche must have a negative pregnancy test at the
screening visit (Visit 1) and at study treatment visit (Visit 2)
Exclusion Criteria:
- Lactating or pregnant female patient
- Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy
of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry
(screening)
- Scheduled to receive concomitant total body irradiation, radiotherapy of the upper
abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after
study drug administration
- Known history of allergy to any component or other contraindications to any 5-HT3
receptor antagonists
- Active infection
- Uncontrolled medical condition
- Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the
ECG assessments at screening. For this purpose, assessment will rely on the automatic
interpretation by the ECG machine
- Patient suffering from ongoing vomiting from any organic etiology (including patients
with history of gastric outlet obstruction or intestinal obstruction due to adhesions
or volvulus) or patients with hydrocephalus
- Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the
administration of the study drug
- Patient who received any drug with potential anti-emetic effect within 24 hours prior
to administration of study treatment, including but not limited to:
- NK1- receptor antagonists (e.g. aprepitant)
- 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
- Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,
chlorpromazine, thiethylperazine);
- Butyrophenones (e.g., droperidol, haloperidol);
- Benzamides (e.g., metoclopramide, alizapride);
- Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for
respiratory disorders and topical steroids for skin disease with doses of = 10 mg of
prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy
regimen or to reduce intracranial pressure are allowed. According to the
guidelines1,2, patients will receive also dexamethasone as a co-medication in
accordance with standard clinical practice and if deemed appropriate by the
Investigator.
- Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;
Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;
- Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
- Herbal preparations containing ephedra or ginger.
- Patient aged = 6 years who received any investigational drug (defined as a medication
with no marketing authorization granted for any age group and any indication) within
90 days prior to Day 1, or patient aged > 6 years who received any investigational
drug within 30 days prior to Day 1 or is expected to receive investigational drugs
prior to study completion
- Patient who participated in any previous trial with palonosetron
;
Inclusion Criteria:
- Written informed consent signed by parent(s)/legal guardians of the pediatric patient
in compliance with the local laws and regulations. In addition signed children's
assent form according to local requirements
- Male or female in- or out-patients from neonates (full term) to <17 years at the time
of randomization
- Patient weight at least 3.2 kg
- Histologically, and/or cytologically (or imaging in the case of brain tumors)
confirmed malignant disease
- Naïve or non-naïve to chemotherapy
- Scheduled and eligible to receive at least one of the moderately or highly emetogenic
chemotherapeutic agents on Study Day 1
- For patients aged = 10 years to <17 years: ECOG PS = 2
- For patients with known hepatic impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known renal impairment: in the Investigator's opinion the impairment
should not jeopardize patient's safety during the study
- For patients with known history or predisposition to cardiac abnormalities: in the
Investigator's opinion the history/predisposition should not jeopardize patient's
safety during the study
- For patients with known clinically relevant abnormal laboratory values: in the
Investigator's opinion the abnormality should not jeopardize the patient's safety
during the study
- Fertile patients (male or female) must use reliable contraceptive measures
- Female patients who have attained menarche must have a negative pregnancy test at the
screening visit (Visit 1) and at study treatment visit (Visit 2)
Exclusion Criteria:
- Lactating or pregnant female patient
- Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy
of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry
(screening)
- Scheduled to receive concomitant total body irradiation, radiotherapy of the upper
abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after
study drug administration
- Known history of allergy to any component or other contraindications to any 5-HT3
receptor antagonists
- Active infection
- Uncontrolled medical condition
- Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the
ECG assessments at screening. For this purpose, assessment will rely on the automatic
interpretation by the ECG machine
- Patient suffering from ongoing vomiting from any organic etiology (including patients
with history of gastric outlet obstruction or intestinal obstruction due to adhesions
or volvulus) or patients with hydrocephalus
- Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the
administration of the study drug
- Patient who received any drug with potential anti-emetic effect within 24 hours prior
to administration of study treatment, including but not limited to:
- NK1- receptor antagonists (e.g. aprepitant)
- 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
- Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,
chlorpromazine, thiethylperazine);
- Butyrophenones (e.g., droperidol, haloperidol);
- Benzamides (e.g., metoclopramide, alizapride);
- Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for
respiratory disorders and topical steroids for skin disease with doses of = 10 mg of
prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy
regimen or to reduce intracranial pressure are allowed. According to the
guidelines1,2, patients will receive also dexamethasone as a co-medication in
accordance with standard clinical practice and if deemed appropriate by the
Investigator.
- Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;
Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;
- Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
- Herbal preparations containing ephedra or ginger.
- Patient aged = 6 years who received any investigational drug (defined as a medication
with no marketing authorization granted for any age group and any indication) within
90 days prior to Day 1, or patient aged > 6 years who received any investigational
drug within 30 days prior to Day 1 or is expected to receive investigational drugs
prior to study completion
- Patient who participated in any previous trial with palonosetron
;
Inclusion Criteria:
- Written informed consent signed by parent(s)/legal guardians of the pediatric patient
in compliance with the local laws and regulations. In addition signed children's
assent form according to local requirements
- Male or female in- or out-patients from neonates (full term) to <17 years at the time
of randomization
- Patient weight at least 3.2 kg
- Histologically, and/or cytologically (or imaging in the case of brain tumors)
confirmed malignant disease
- Naïve or non-naïve to chemotherapy
- Scheduled and eligible to receive at least one of the moderately or highly emetogenic
chemotherapeutic agents on Study Day 1
- For patients aged = 10 years to <17 years: ECOG PS = 2
- For patients with known hepatic impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known renal impairment: in the Investigator's opinion the impairment
should not jeopardize patient's safety during the study
- For patients with known history or predisposition to cardiac abnormalities: in the
Investigator's opinion the history/predisposition should not jeopardize patient's
safety during the study
- For patients with known clinically relevant abnormal laboratory values: in the
Investigator's opinion the abnormality should not jeopardize the patient's safety
during the study
- Fertile patients (male or female) must use reliable contraceptive measures
- Female patients who have attained menarche must have a negative pregnancy test at the
screening visit (Visit 1) and at study treatment visit (Visit 2)
Exclusion Criteria:
- Lactating or pregnant female patient
- Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy
of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry
(screening)
- Scheduled to receive concomitant total body irradiation, radiotherapy of the upper
abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after
study drug administration
- Known history of allergy to any component or other contraindications to any 5-HT3
receptor antagonists
- Active infection
- Uncontrolled medical condition
- Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the
ECG assessments at screening. For this purpose, assessment will rely on the automatic
interpretation by the ECG machine
- Patient suffering from ongoing vomiting from any organic etiology (including patients
with history of gastric outlet obstruction or intestinal obstruction due to adhesions
or volvulus) or patients with hydrocephalus
- Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the
administration of the study drug
- Patient who received any drug with potential anti-emetic effect within 24 hours prior
to administration of study treatment, including but not limited to:
- NK1- receptor antagonists (e.g. aprepitant)
- 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
- Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,
chlorpromazine, thiethylperazine);
- Butyrophenones (e.g., droperidol, haloperidol);
- Benzamides (e.g., metoclopramide, alizapride);
- Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for
respiratory disorders and topical steroids for skin disease with doses of = 10 mg of
prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy
regimen or to reduce intracranial pressure are allowed. According to the
guidelines1,2, patients will receive also dexamethasone as a co-medication in
accordance with standard clinical practice and if deemed appropriate by the
Investigator.
- Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;
Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;
- Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
- Herbal preparations containing ephedra or ginger.
- Patient aged = 6 years who received any investigational drug (defined as a medication
with no marketing authorization granted for any age group and any indication) within
90 days prior to Day 1, or patient aged > 6 years who received any investigational
drug within 30 days prior to Day 1 or is expected to receive investigational drugs
prior to study completion
- Patient who participated in any previous trial with palonosetron
;
Inclusion Criteria:
- Written informed consent signed by parent(s)/legal guardians of the pediatric patient
in compliance with the local laws and regulations. In addition signed children's
assent form according to local requirements
- Male or female in- or out-patients from neonates (full term) to <17 years at the time
of randomization
- Patient weight at least 3.2 kg
- Histologically, and/or cytologically (or imaging in the case of brain tumors)
confirmed malignant disease
- Naïve or non-naïve to chemotherapy
- Scheduled and eligible to receive at least one of the moderately or highly emetogenic
chemotherapeutic agents on Study Day 1
- For patients aged = 10 years to <17 years: ECOG PS = 2
- For patients with known hepatic impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known renal impairment: in the Investigator's opinion the impairment
should not jeopardize patient's safety during the study
- For patients with known history or predisposition to cardiac abnormalities: in the
Investigator's opinion the history/predisposition should not jeopardize patient's
safety during the study
- For patients with known clinically relevant abnormal laboratory values: in the
Investigator's opinion the abnormality should not jeopardize the patient's safety
during the study
- Fertile patients (male or female) must use reliable contraceptive measures
- Female patients who have attained menarche must have a negative pregnancy test at the
screening visit (Visit 1) and at study treatment visit (Visit 2)
Exclusion Criteria:
- Lactating or pregnant female patient
- Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy
of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry
(screening)
- Scheduled to receive concomitant total body irradiation, radiotherapy of the upper
abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after
study drug administration
- Known history of allergy to any component or other contraindications to any 5-HT3
receptor antagonists
- Active infection
- Uncontrolled medical condition
- Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the
ECG assessments at screening. For this purpose, assessment will rely on the automatic
interpretation by the ECG machine
- Patient suffering from ongoing vomiting from any organic etiology (including patients
with history of gastric outlet obstruction or intestinal obstruction due to adhesions
or volvulus) or patients with hydrocephalus
- Patient who experienced any vomiting, retching, or nausea within 24 hours prior to the
administration of the study drug
- Patient who received any drug with potential anti-emetic effect within 24 hours prior
to administration of study treatment, including but not limited to:
- NK1- receptor antagonists (e.g. aprepitant)
- 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
- Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,
chlorpromazine, thiethylperazine);
- Butyrophenones (e.g., droperidol, haloperidol);
- Benzamides (e.g., metoclopramide, alizapride);
- Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for
respiratory disorders and topical steroids for skin disease with doses of = 10 mg of
prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy
regimen or to reduce intracranial pressure are allowed. According to the
guidelines1,2, patients will receive also dexamethasone as a co-medication in
accordance with standard clinical practice and if deemed appropriate by the
Investigator.
- Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;
Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;
- Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
- Herbal preparations containing ephedra or ginger.
- Patient aged = 6 years who received any investigational drug (defined as a medication
with no marketing authorization granted for any age group and any indication) within
90 days prior to Day 1, or patient aged > 6 years who received any investigational
drug within 30 days prior to Day 1 or is expected to receive investigational drugs
prior to study completion
- Patient who participated in any previous trial with palonosetron
",NULL,Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1;Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1,Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1,2010-022872-30; NCT01442376; PALO-10-20,2012-05-10,no,Chemotherapy-Induced Nausea and Vomiting; Nausea and vomiting,Arm 1 Drug: Palonosetron; Arm 2 Drug: Palonosetron; Arm 3 Drug: Ondansetron; Arm 4 Drug: Placebo to Ondansetron; Arm 5 Drug: Placebo to Ondansetron; Arm 6 Drug: Placebo to Palonosetron,Interventional,Randomized controlled trial,Blinded,Active control (effective treament of control group),Parallel,III,"- Change in proportion of patients with Complete Response (CR) defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 during first cycle; time frame: 0 to 24 hours after T0; Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy
","- Proportion of patients with CR in delayed and overall phases.; time frame: from >24 to 120 hours (delayed phase) after T0; 0 to 120 hours (overall period) after T0; 0 to 24 hours after T0 (acute phase); For each period during first cycle: Proportion of patients without vomiting, without emetic episodes, without antiemetic rescue medication and without nausea (patients aged ≥ 6 years)
",United States; Argentina; Austria; Bulgaria; Chile; Czech Republic; Estonia; France; Germany; Hungary; Peru; Poland; Romania; Russian Federation; Serbia; Ukraine,[---]* Cologne; [---]* Freiburg,2011-09-30,NA,492,2012-11-01,"- Written informed consent signed by parent(s)/legal guardians of the pediatric patient
in compliance with the local laws and regulations. In addition signed children's
assent form according to local requirements
- Male or female in- or out-patients from neonates (full term) to <17 years at the time
of randomization
- Patient weight at least 3.2 kg
- Histologically, and/or cytologically (or imaging in the case of brain tumors)
confirmed malignant disease
- Naïve or non-naïve to chemotherapy
- Scheduled and eligible to receive at least one of the moderately or highly emetogenic
chemotherapeutic agents on Study Day 1
- For patients aged ≥ 10 years to <17 years: ECOG PS ≤ 2
- For patients with known hepatic impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known renal impairment: in the Investigator's opinion the
impairment should not jeopardize patient's safety during the study
- For patients with known history or predisposition to cardiac abnormalities: in the
Investigator's opinion the history/predisposition should not jeopardize patient's
safety during the study
- For patients with known clinically relevant abnormal laboratory values: in the
Investigator's opinion the abnormality should not jeopardize the patient's safety
during the study
- Fertile patients (male or female) must use reliable contraceptive measures
- Female patients who have attained menarche must have a negative pregnancy test at the
screening visit (Visit 1) and at study treatment visit (Visit 2)
","- Lactating or pregnant female patient
- Patient has received total body irradiation, upper abdomen radiotherapy, radiotherapy
of the cranium, craniospinal regions or the pelvis within 1 week prior to study entry
(screening)
- Scheduled to receive concomitant total body irradiation, radiotherapy of the upper
abdomen, lower thorax region, or cranium/craniospinal regions up to 24 hours after
study drug administration
- Known history of allergy to any component or other contraindications to any 5-HT3
receptor antagonists
- Active infection
- Uncontrolled medical condition
- Marked baseline prolongation of QTc interval [QTcB or QTcF > 460 msec] in any of the
ECG assessments at screening. For this purpose, assessment will rely on the automatic
interpretation by the ECG machine
- Patient suffering from ongoing vomiting from any organic etiology (including patients
with history of gastric outlet obstruction or intestinal obstruction due to adhesions
or volvulus) or patients with hydrocephalus
- Patient who experienced any vomiting, retching, or nausea within 24 hours prior to
the administration of the study drug
- Patient who received any drug with potential anti-emetic effect within 24 hours prior
to administration of study treatment, including but not limited to:
- NK1- receptor antagonists (e.g. aprepitant)
- 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
- Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine,
chlorpromazine, thiethylperazine);
- Butyrophenones (e.g., droperidol, haloperidol);
- Benzamides (e.g., metoclopramide, alizapride);
- Corticosteroids (e.g., prednisone, methylprednisolone; except inhaled steroids for
respiratory disorders and topical steroids for skin disease with doses of ≤ 10 mg of
prednisone daily or its equivalent); Corticosteroids foreseen in the chemotherapy
regimen or to reduce intracranial pressure are allowed. According to the
guidelines1,2, patients will receive also dexamethasone as a co-medication in
accordance with standard clinical practice and if deemed appropriate by the
Investigator.
- Dimenhydrinate; Hydroxyzine; Domperidone; Lorazepam; Cyclizine; Cannabinoids;
Scopolamine; Trimethobenzamide HCl; Meclizine hydrochloride; Pseudoephedrine HCl;
- Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
- Herbal preparations containing ephedra or ginger.
- Patient aged ≤ 6 years who received any investigational drug (defined as a medication
with no marketing authorization granted for any age group and any indication) within
90 days prior to Day 1, or patient aged > 6 years who received any investigational
drug within 30 days prior to Day 1 or is expected to receive investigational drugs
prior to study completion
- Patient who participated in any previous trial with palonosetron
","A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Different Doses of Palonosetron Compared to Ondansetron in the Prevention of CINV in Pediatric Patients Undergoing Single and Repeated Cycles of MEC or HEC","Recruiting complete, follow-up complete",Helsinn Healthcare SA,NA,Arm 1 Drug: Palonosetron; Arm 2 Drug: Palonosetron; Arm 3 Drug: Ondansetron; Arm 4 Drug: Placebo to Ondansetron; Arm 5 Drug: Placebo to Ondansetron; Arm 6 Drug: Placebo to Palonosetron,2011-09-30,2011-09-21,2011-09-21,502,Interventional,FALSE,FALSE,TRUE,FALSE,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,2011,2014-08-04,TRUE,TRUE,TRUE
14878,NCT00689728,NA,NCT00689728,NCT: 2008-06-02 ICTRP: 2008-06-02 DRKS: NA,1,1,NA,1,1,a,Criteria more specific in article,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 100 ICTRP: 100 DRKS: NA,100,1,1,2,0,NA,"Triple (Participant, Care Provider, Investigator)",Double,worse,0,no outcome,ganzer Artikel,https://doi.org/10.1136/annrheumdis-2012-202775,NA,2008-06-04,NA,2008-06-30,2010-05-31,Interventional,A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy,A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFα Inhibitor Therapy,Completed,Phase 2,100,Actual,Eli Lilly and Company,Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16,"Number of Participants Experiencing An Adverse Event;Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16;Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16;Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16;Change From Baseline in Tender Joint Count at Week 16;Change From Baseline in Swollen Joint Count at Week 16;Change From Baseline in Participant's Assessment of Joint Pain at Week 16;Change From Baseline in Participant's Assessment of Disease Activity at Week 16;Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16;Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16;Percent Change From Baseline in C-reactive Protein (CRP) at Week 16;Change From Baseline in Disease Activity Score (DAS28) at Week 16;Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16;Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16;Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16;Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes;Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16;Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state;Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)",H9B-MC-BCDG;11351,A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFa Inhibitor Therapy,A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy,,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 2,2008-06-02,2008-06-20,100,Completed,Eli Lilly and Company,NULL,united states;argentina;austria;belgium;brazil;canada;germany;mexico;poland;puerto rico;argentina;austria;belgium;brazil;canada;germany;mexico;poland;puerto rico;united states;france,Biological: LY2127399;Drug: Placebo,"
Inclusion Criteria:
- Have given written informed consent approval
- Women must not be at risk to become pregnant during study participation
- Diagnosis of Rheumatoid Arthritis
- Active Rheumatoid Arthritis
- Current, regular use of Methotrexate, at a stable dose
- Have been on at least 1 biologic tumor necrosis factor-alpha (TNFa) inhibitor therapy
and either failed or were intolerant to treatment
- Other criteria to be reviewed by study doctor
Exclusion Criteria:
- Use of excluded medications (reviewed by study doctor)
- Have medical findings which, in the opinion of the study doctor, put patient at an
unacceptable risk for participation in the study
- Have had recent or ongoing infection which, in the opinion of the study doctor put
patient at an unacceptable risk for participation
- Evidence of tuberculosis
- Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as
juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or
psoriatic arthritis.
- Other criteria to be reviewed by study doctor
",NULL,Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16,"Number of Participants Experiencing An Adverse Event;Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16;Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16;Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16;Change From Baseline in Tender Joint Count at Week 16;Change From Baseline in Swollen Joint Count at Week 16;Change From Baseline in Participant's Assessment of Joint Pain at Week 16;Change From Baseline in Participant's Assessment of Disease Activity at Week 16;Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16;Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16;Percent Change From Baseline in C-reactive Protein (CRP) at Week 16;Change From Baseline in Disease Activity Score (DAS28) at Week 16;Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16;Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16;Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16;Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes;Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16;Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state;Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-06-30,2008-06-02,2008-06-02,100,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2008,2018-11-10,TRUE,FALSE,TRUE
27296,NCT00791141,DRKS00003939,DRKS00003939,NCT: NA ICTRP: 2012-05-09 DRKS: 2012-05-09,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 80 DRKS: [---]* 80,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2008-11-14,NA,2008-08-31,2013-09-30,Interventional,Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer,"Multicenter, Open-label Phase II Trial on Post-surgery Chemoradiation in Combination With Cetuximab in Squamous Cell Carcinoma of the Head and Neck With High Risk of Locoregional Recurrence.",Completed,Phase 2,80,Actual,"Heinrich-Heine University, Duesseldorf",Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate.,Incidence of Loco-regional relapse;Disease-free survival;Progression-free survival;Overall survival;The rate of patients with secondary primary neoplasm;The incidence of late toxicity,ACCRA-HN,Adjuvant Cetuximab and Chemoradiation in Head and Neck Cancer,"Multicenter, Open-label Phase II Trial on Post-surgery Chemoradiation in Combination With Cetuximab in Squamous Cell Carcinoma of the Head and Neck With High Risk of Locoregional Recurrence.",,,Interventional,"Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 2,2008-11-13,2008-08-20,80,Completed,"Heinrich-Heine University, Duesseldorf",NULL,germany,Drug: Cetuximab,"
Inclusion Criteria:
- Signed written informed consent;
- Males or females between 18 and 70 years of age;
- Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx
and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks
(maximum) ago;
- To be categorized as high risk patients have to fulfil at least one of the following
criteria:
- R0 - resection <5 mm margin
- R1 - resection
- Extracapsular nodal extension;
- no previous chemotherapy, radiotherapy;
- Performance status ECOG: 0 - 1;
- Contraception in male and female patients if of childbearing potential, willingness
to use effective contraceptive method for the study duration and 2 months
post-dosing;
- Adequate renal, liver and hematological functions (within maximum 9 weeks until
surgery):
- Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 100 x
10^9/L, hemoglobin > 10.0 g/dL
- Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, ?-GT < 3 x ULN
- Adequate renal function: creatinine clearance > =60 ml/min
- No distant metastases;
Exclusion Criteria:
- Nasopharyngeal carcinoma;
- R2 resection;
- Invalid informed consent;
- Performance Status > 1;
- Previous chemotherapy or radiotherapy for carcinoma of the head and neck;
- Prior exposure to EGFR pathway targeting therapy;
- Other serious illness or medical conditions:
- Unstable cardiac disease despite treatment, congestive heart failure NYHA grade
3 and 4;
- Clinically significantly abnormal electrocardiogram (ECG) or left ventricular
ejection fraction (LVEF) below the institutional range of the normal
- Significant neurologic or psychiatric disorders including dementia or seizures;
- Active uncontrolled infection;
- Active disseminated intravascular coagulation;
- Other serious underlying medical conditions which could impair the ability of
the patient to participate in the study;
- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria
(NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical
impairment due to tumor mass;
- Having participated in another therapeutic clinical trial or any investigational
agent in the preceding 30 days;
- Known allergic/hypersensitivity reaction to any of the components of the treatment;
- Pregnancy (absence confirmed by serum/urine ß-HCG) or breast-feeding;
- Known drug abuse;
- Other previous malignancy within 5 years, with exception of a history of a previous
basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;
- Legal incapacity or limited legal capacity;
- Sensitivity and incompatibility against 5-Fluorouracil
- Sensitivity and incompatibility against platinum-compounds
- Known incompatibilities >grade 3 towards cetuximab
- expected incompliance of patient (e.g. in case of severe alcohol addiction)
- Dental evaluation: Pre treatment dental care before start of radiochemotherapy
(approximately 8 to 10 days lapse-time is needed for complete recovery before
initiation of radiation therapy).
",NULL,Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate.,Incidence of Loco-regional relapse;Disease-free survival;Progression-free survival;Overall survival;The rate of patients with secondary primary neoplasm;The incidence of late toxicity,NCT00791141; ACCRA-HN,2012-05-09,yes,Head and Neck Cancer; Malignant neoplasm of hypopharynx; Malignant neoplasm of oropharynx; Malignant neoplasm of larynx,Arm 1 Drug: Cetuximab,Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),II,- Rate of patients experiencing grade 3/4 acute toxicities not considering grade 3/4 skin tox. outside the radiation portals combined with 2-years disease-free survival rate.; time frame: any toxicities occurring within 90 days post radiation start
,- Incidence of Loco-regional relapse; time frame: assessment after patient has completed follow-up
- Disease-free survival; time frame: time from start of surgery to the first evidence of loco-regional or distant tumor relapse or death
- Progression-free survival; time frame: from start of surgery to the first observation of disease progression or death
- Overall survival; time frame: censored at the time of last documented efficacy
- The rate of patients with secondary primary neoplasm; time frame: assessment after patient has completed follow-up
- The incidence of late toxicity; time frame: beyond 90 days after start of radiation therapy
,Germany,[---]* Munich; [---]* Freiburg; [---]* Heidelberg; [---]* Tuebingen; [---]* Ulm; [---]* Essen; [---]* Mainz; [---]* Lübeck; [---]* Jena; [---]* Berlin,2008-08-31,NA,80,NA,"- Signed written informed consent;
- Males or females between 18 and 70 years of age;
- Surgically resected squamous cell carcinomas of the hypopharynx, oropharynx, larynx
and oral cavity with high risk of locoregional recurrence not more than 6-9 weeks
(maximum) ago;
- To be categorized as high risk patients have to fulfil at least one of the following
criteria:
- R0 - resection <5 mm margin
- R1 - resection
- Extracapsular nodal extension;
- no previous chemotherapy, radiotherapy;
- Performance status ECOG: 0 - 1;
- Contraception in male and female patients if of childbearing potential, willingness
to use effective contraceptive method for the study duration and 2 months
post-dosing;
- Adequate renal, liver and hematological functions (within maximum 9 weeks until
surgery):
- Adequate bone marrow function: neutrophils > 1.5 x 10^9/L, platelets > 100 x
10^9/L, hemoglobin > 10.0 g/dL
- Adequate liver function: Bilirubin < 2.0 mg/dL, AST, ALT, AP, γ-GT < 3 x ULN
- Adequate renal function: creatinine clearance > =60 ml/min
- No distant metastases;
","- Nasopharyngeal carcinoma;
- R2 resection;
- Invalid informed consent;
- Performance Status > 1;
- Previous chemotherapy or radiotherapy for carcinoma of the head and neck;
- Prior exposure to EGFR pathway targeting therapy;
- Other serious illness or medical conditions:
- Unstable cardiac disease despite treatment, congestive heart failure NYHA grade
3 and 4;
- Clinically significantly abnormal electrocardiogram (ECG) or left ventricular
ejection fraction (LVEF) below the institutional range of the normal
- Significant neurologic or psychiatric disorders including dementia or seizures;
- Active uncontrolled infection;
- Active disseminated intravascular coagulation;
- Other serious underlying medical conditions which could impair the ability of
the patient to participate in the study;
- Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria
(NCI-CTC v3.0) grade 2 or ototoxicity grade 2, except if due to trauma or mechanical
impairment due to tumor mass;
- Having participated in another therapeutic clinical trial or any investigational
agent in the preceding 30 days;
- Known allergic/hypersensitivity reaction to any of the components of the treatment;
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding;
- Known drug abuse;
- Other previous malignancy within 5 years, with exception of a history of a previous
basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;
- Legal incapacity or limited legal capacity;
- Sensitivity and incompatibility against 5-Fluorouracil
- Sensitivity and incompatibility against platinum-compounds
- Known incompatibilities >grade 3 towards cetuximab
- expected incompliance of patient (e.g. in case of severe alcohol addiction)
- Dental evaluation: Pre treatment dental care before start of radiochemotherapy
(approximately 8 to 10 days lapse-time is needed for complete recovery before
initiation of radiation therapy).
","Multicenter, Open-label Phase II Trial on Post-surgery Chemoradiation in Combination With Cetuximab in Squamous Cell Carcinoma of the Head and Neck With High Risk of Locoregional Recurrence.","Recruiting complete, follow-up continuing","Heinrich-Heine University, Duesseldorf; Department of Radiotherapy and Radiological Oncology; Department of Radiotherapy and Radiological Oncology",[---]*; [---]*; [---]*,Arm 1 Drug: Cetuximab,2008-08-31,2008-11-13,2008-11-13,80,Interventional,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2008,2014-01-22,TRUE,TRUE,FALSE
13302,NCT00962364,NA,NCT00962364,NCT: 2009-08-19 ICTRP: 2009-08-19 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,4,NA,"Evaluation of safety interpreted as ""adverse events"". No AM.",NA,NA,NA,NCT: Anticipated 1500 ICTRP: 1500 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2009-08-20,NA,2001-10-31,2021-12-31,Observational,Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease,Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease,"Active, not recruiting",NA,1500,Anticipated,Johann Wolfgang Goethe University Hospital,Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease,,201-01-BMC-Reg,Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease,Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease,,,Observational,,,2009-08-19,2001-10-20,1500,"Active, not recruiting",Johann Wolfgang Goethe University Hospital,NULL,germany,Biological: autologous bone marrow-derived cells,"
Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart
failure due to
- acute myocardial infarction or
- ischemic cardiomyopathy with or without previous myocardial infarction or
- dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease,
history of myocarditis (no active myocardial infection present)
Exclusion Criteria:
- none, all patients meeting the inclusion criteria will be eligible.
",NULL,Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-10-31,2009-08-19,2009-08-19,1500,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2001,2020-02-25,TRUE,FALSE,FALSE
16756,NCT00384605,NA,NCT00384605,NCT: 2006-10-03 ICTRP: 2006-10-03 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no metric",3,NA,"no AM, no metric",NCT: Actual 1000 ICTRP: 1000 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-10-06,NA,2006-10-31,2008-12-31,Interventional,An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED),"A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension",Terminated,Phase 3,1000,Actual,Merck Sharp & Dohme Corp.,Body weight after 52 weeks of treatment,"Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment",2006_513;0364-037,An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED),"A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",Phase 3,2006-10-03,2006-10-20,1000,Terminated,Merck Sharp & Dohme Corp.,NULL,united states;australia;austria;czech republic;denmark;finland;france;germany;new zealand;sweden,Drug: taranabant;Drug: placebo,"
Inclusion Criteria:
- Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2
and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with
obesity-related comorbidities). Obesity-related comorbidities associated with a BMI
of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
- Stable weight (+/-3 kg) for at least 3 months prior to study start
Exclusion Criteria:
- History of diabetes mellitis, major psychiatric disorder, significant cardiovascular
disease, stroke, TIA, neurological disorder, non-febrile seizures
- Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg
",NULL,Body weight after 52 weeks of treatment,"Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-10-31,2006-10-03,2006-10-03,1000,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2006,2015-03-12,TRUE,FALSE,FALSE
10058,NCT01479868,NA,NCT01479868,NCT: 2011-10-18 ICTRP: 2011-10-18 DRKS: NA,1,1,NA,2,1,ra,"No contradictions, but some criteria more specific in register (required liver biopsy is not mentioned in paper) and some more specific in paper (HIV-1 coinfection with cutpoint >= 6 months)",2,1,NA,5,1,NA,5,1,NA,NCT: Actual 109 ICTRP: 109 DRKS: NA,106,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://academic.oup.com/cid/article/59/11/1579/1746507?login=true,NA,2011-11-28,NA,2011-10-31,2013-08-31,Interventional,"A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1","A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNα-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1)",Completed,Phase 3,109,Actual,Janssen R&D Ireland,Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12),Percentage of Participants With On-treatment Failure;Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24);Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable;Percentage of Participants With Viral Breakthrough;Percentage of Participants With Viral Relapse;Percentage of Participants With Normalized Alanine Aminotransferase Levels;Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure;Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load;Mean Change From Baseline in CD4+ Cell Count;Change From Baseline in CD4+ Cell Count in Percentage;Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs),TMC435-TiDP16-C212;CR018334,"A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1","A Phase III Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of TMC435 Plus PegIFNa-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Subjects Who Are Co-infected With Human Immunodeficiency Virus Type 1 (HIV-1)",;;;,;;;,Interventional,,Phase 3,2011-10-18,2011-10-20,109,Completed,Janssen R&D Ireland,NULL,united states;canada;france;germany;portugal;puerto rico;spain;united kingdom;canada;france;germany;portugal;puerto rico;spain;united kingdom;united states;united states;canada;france;germany;portugal;puerto rico;spain;united kingdom;canada;france;germany;portugal;puerto rico;spain;united kingdom;united states;united states;canada;france;germany;portugal;puerto rico;spain;united kingdom;canada;france;germany;portugal;puerto rico;spain;united kingdom;united states;united states;canada;france;germany;portugal;puerto rico;spain;united kingdom;canada;france;germany;portugal;puerto rico;spain;united kingdom;united states,Drug: TMC435;Drug: Pegylated interferon alpha-2a;Drug: Ribavirin;Drug: TMC435;Drug: Pegylated interferon alpha-2a;Drug: Ribavirin;Drug: TMC435;Drug: Pegylated interferon alpha-2a;Drug: Ribavirin;Drug: TMC435;Drug: Pegylated interferon alpha-2a;Drug: Ribavirin,"
Inclusion Criteria:
- A liver biopsy required within 3 years prior to screening unless the patient has a
contraindication for a liver biopsy
- Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within
2 years prior screening must have an ultrasound taken within 2 months prior to the
screening visit or during screening with no findings suspicious for hepatocellular
carcinoma (HCC)
- Genotype-1 hepatitis C virus (HCV) infection
- Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
- Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months
prior to screening
Exclusion Criteria:
- Patient showing evidence of hepatic decompensation (ie, history or current evidence of
ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less
than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international
normalized ratio [INR] more than 1.5)
- Any liver disease of non-HCV etiology
- Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
- An acute HIV-1 infection; or HIV-2 infection
- Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening
;
Inclusion Criteria:
- A liver biopsy required within 3 years prior to screening unless the patient has a
contraindication for a liver biopsy
- Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within
2 years prior screening must have an ultrasound taken within 2 months prior to the
screening visit or during screening with no findings suspicious for hepatocellular
carcinoma (HCC)
- Genotype-1 hepatitis C virus (HCV) infection
- Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
- Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months
prior to screening
Exclusion Criteria:
- Patient showing evidence of hepatic decompensation (ie, history or current evidence of
ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less
than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international
normalized ratio [INR] more than 1.5)
- Any liver disease of non-HCV etiology
- Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
- An acute HIV-1 infection; or HIV-2 infection
- Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening
;
Inclusion Criteria:
- A liver biopsy required within 3 years prior to screening unless the patient has a
contraindication for a liver biopsy
- Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within
2 years prior screening must have an ultrasound taken within 2 months prior to the
screening visit or during screening with no findings suspicious for hepatocellular
carcinoma (HCC)
- Genotype-1 hepatitis C virus (HCV) infection
- Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
- Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months
prior to screening
Exclusion Criteria:
- Patient showing evidence of hepatic decompensation (ie, history or current evidence of
ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less
than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international
normalized ratio [INR] more than 1.5)
- Any liver disease of non-HCV etiology
- Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
- An acute HIV-1 infection; or HIV-2 infection
- Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening
;
Inclusion Criteria:
- A liver biopsy required within 3 years prior to screening unless the patient has a
contraindication for a liver biopsy
- Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within
2 years prior screening must have an ultrasound taken within 2 months prior to the
screening visit or during screening with no findings suspicious for hepatocellular
carcinoma (HCC)
- Genotype-1 hepatitis C virus (HCV) infection
- Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
- Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months
prior to screening
Exclusion Criteria:
- Patient showing evidence of hepatic decompensation (ie, history or current evidence of
ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less
than 3.3 gm per dL, prolonged prothrombin time [PT] expressed as international
normalized ratio [INR] more than 1.5)
- Any liver disease of non-HCV etiology
- Co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive)
- An acute HIV-1 infection; or HIV-2 infection
- Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening
",NULL,Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12);Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12),Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24);Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable;Percentage of Participants With On-treatment Failure;Percentage of Participants With Viral Breakthrough;Percentage of Participants With Viral Relapse;Percentage of Participants With Normalized Alanine Aminotransferase Levels;Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure;Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load;Mean Change From Baseline in CD4+ Cell Count;Change From Baseline in CD4+ Cell Count in Percentage;Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-10-31,2011-10-18,2011-10-18,109,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2011,2014-10-28,TRUE,FALSE,FALSE
17298,NCT00296504,NA,NCT00296504,NCT: 2006-02-24 ICTRP: 2006-02-24 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 753 ICTRP: 753 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-02-27,NA,2001-11-30,2010-10-31,Interventional,A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects,An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects,Completed,Phase 3,753,Actual,ViiV Healthcare,"Number of Participants With Any Adverse Event (AE): Interim Analysis;Number of Participants With Any Adverse Event (AE): Final Analysis;Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216;Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432;Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216;Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168;Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432;Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216;Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168;Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432","Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed);Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed);Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed);Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis;Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis;Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216;Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168;Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432;Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline;Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions;Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions",APV30005,A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects,An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects,;;;,;;;,Interventional,,Phase 3,2006-02-24,2001-11-20,753,Completed,ViiV Healthcare,GlaxoSmithKline,united states;brazil;chile;france;italy;portugal;spain;united kingdom;brazil;chile;france;italy;portugal;spain;united kingdom;united states;argentina;australia;austria;belgium;canada;costa rica;germany;hungary;israel;latvia;panama;poland;puerto rico;south africa;switzerland;united states;brazil;chile;france;italy;portugal;spain;united kingdom;brazil;chile;france;italy;portugal;spain;united kingdom;united states;argentina;australia;austria;belgium;canada;costa rica;germany;hungary;israel;latvia;panama;poland;puerto rico;south africa;switzerland;united states;brazil;chile;france;italy;portugal;spain;united kingdom;brazil;chile;france;italy;portugal;spain;united kingdom;united states;argentina;australia;austria;belgium;canada;costa rica;germany;hungary;israel;latvia;panama;poland;puerto rico;south africa;switzerland;united states;brazil;chile;france;italy;portugal;spain;united kingdom;brazil;chile;france;italy;portugal;spain;united kingdom;united states;argentina;australia;austria;belgium;canada;costa rica;germany;hungary;israel;latvia;panama;poland;puerto rico;south africa;switzerland,Drug: fosamprenavir (GW433908);Drug: ritonavir;Drug: fosamprenavir (GW433908);Drug: ritonavir;Drug: fosamprenavir (GW433908);Drug: ritonavir;Drug: fosamprenavir (GW433908);Drug: ritonavir,"
Inclusion Criteria:
- Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age
according to local requirements).
- Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or
PRO30017 or have participated in APV30001 or other studies as deemed appropriate by
the project team.
Exclusion Criteria:
- Permanent discontinuation of GW433908 in a previous study due to intolerance.
- An active CDC Class C Event.
- Any condition which, in the opinion of the investigator, would preclude a subject from
participation.
;
Inclusion Criteria:
- Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age
according to local requirements).
- Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or
PRO30017 or have participated in APV30001 or other studies as deemed appropriate by
the project team.
Exclusion Criteria:
- Permanent discontinuation of GW433908 in a previous study due to intolerance.
- An active CDC Class C Event.
- Any condition which, in the opinion of the investigator, would preclude a subject from
participation.
;
Inclusion Criteria:
- Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age
according to local requirements).
- Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or
PRO30017 or have participated in APV30001 or other studies as deemed appropriate by
the project team.
Exclusion Criteria:
- Permanent discontinuation of GW433908 in a previous study due to intolerance.
- An active CDC Class C Event.
- Any condition which, in the opinion of the investigator, would preclude a subject from
participation.
;
Inclusion Criteria:
- Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age
according to local requirements).
- Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or
PRO30017 or have participated in APV30001 or other studies as deemed appropriate by
the project team.
Exclusion Criteria:
- Permanent discontinuation of GW433908 in a previous study due to intolerance.
- An active CDC Class C Event.
- Any condition which, in the opinion of the investigator, would preclude a subject from
participation.
",NULL,"Number of Participants With Any Adverse Event (AE): Interim Analysis;Number of Participants With Any Adverse Event (AE): Final Analysis;Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216;Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432;Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216;Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168;Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432;Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216;Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168;Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432;Number of Participants With Any Adverse Event (AE): Interim Analysis;Number of Participants With Any Adverse Event (AE): Final Analysis;Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216;Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432;Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216;Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168;Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432;Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216;Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168;Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432","Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed);Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed);Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed);Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis;Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis;Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216;Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168;Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432;Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline;Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions;Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-11-30,2006-02-24,2006-02-24,753,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2013-04-11,TRUE,FALSE,FALSE
5266,NCT02443324,NA,NCT02443324,NCT: 2015-05-11 ICTRP: 2015-05-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosages,5,NA,NA,4,NA,"definitions of ""response"", ""stable disease"" etc. missing",NCT: Actual 155 ICTRP: 155 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,Abstract,10.1200/JCO.2017.35.6_suppl.349,NA,2015-05-13,NA,2015-07-29,2021-05-31,Interventional,"A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer","An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus Pembrolizumab in Patients With Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer","Active, not recruiting",Phase 1,155,Actual,Eli Lilly and Company,Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs),Proportion of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)];Proportion of Participants who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)];Duration of Response (DoR);Time to First Response (TTR);Progression Free Survival (PFS);Overall Survival (OS);Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab,I4T-MC-JVDF;2015-001473-40;KEYNOTE -098;15787,"A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer","An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus Pembrolizumab in Patients With Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer",,,Interventional,Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1,2015-05-11,2015-07-29,155,"Active, not recruiting",Eli Lilly and Company,Merck Sharp & Dohme Corp.,united states;france;germany;japan;spain;united kingdom;france;germany;japan;spain;united kingdom;united states,Drug: Ramucirumab;Drug: Pembrolizumab,"
Inclusion Criteria:
- Metastatic disease or locally advanced, unresectable disease.
- Has histopathologically confirmed gastric or GEJ adenocarcinoma with documented
disease progression after 0-2 prior lines of systemic therapy
- Has histopathologically confirmed nonsquamous or squamous NSCLC with documented
disease progression after 0-3 prior lines of systemic therapy
- Has histopathologically confirmed transitional cell carcinoma of the urothelium
(bladder, urethra, or renal pelvis) with documented disease progression after 1-3
prior lines of systemic therapy
- Has histologically confirmed biliary tract adenocarcinoma with documented
progression after 1-2 prior lines of systemic therapy
- Availability of tumor tissue for biomarker analysis from a newly obtained core or
excisional biopsy or willing to undergo a tumor biopsy. For first line NSCLC
participants only, PD-L1 expression should be 1% or higher.
- Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Has adequate organ function.
- Have an anticipated life expectancy of =3 months.
Exclusion Criteria:
- Have known brain metastases.
- Has received =3 lines of prior systemic therapy for gastric or GEJ adenocarcinoma and
BTC or =4 lines for NSCLC or urothelial cancer.
- Has active autoimmune disease.
- Known human immunodeficiency virus (HIV) infection.
- Known active hepatitis B or hepatitis C infection.
- Has received any previous systemic therapy targeting vascular endothelial growth
factor (VEGF) or VEGF receptor, or programmed death (PD) 1 or PD-ligand 1/2 signaling
pathways.
- Have received a live vaccine within 30 days prior to enrollment. Seasonal flu vaccines
that do not contain live virus are permitted.
- Have had a serious or non-healing wound, ulcer, or bone fracture within 28 days prior
to enrollment.
- Have an elective or a planned major surgery during the course of the trial or has
undergone major surgery within 28 days prior to enrollment.
",NULL,Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs),Proportion of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)];Proportion of Participants who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)];Duration of Response (DoR);Time to First Response (TTR);Progression Free Survival (PFS);Overall Survival (OS);Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-07-29,2015-05-11,2015-05-11,155,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2020-10-16,TRUE,FALSE,FALSE
16315,NCT00441727,NA,NA,NCT: 2007-02-27 ICTRP: NA DRKS: NA,1,1,NA,1,1,a,"Criteria more specific in paper (e.g. additional ""Cardiovascular exclusion criteria were unstable hypertension"")",2,1,NA,5,1,NA,5,1,NA,NCT: Actual 2426 ICTRP: NA DRKS: NA,2426,1,1,2,1,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Quadruple,ok,1,NA,ganzer Artikel,https://doi.org/10.1136/hrt.2010.217547,NA,2007-03-01,NA,2007-02-28,2008-08-31,Interventional,Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA),"A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)",Completed,Phase 3,2426,Actual,AstraZeneca,Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).,Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.;Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.;Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.;Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.;Number of Participants With Gastric and/or Duodenal Erosions.,EudraCT No. 2006-005073-22;D961FC00003,Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA),"A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)",;;;;;;;,;;;;;;;,Interventional,,Phase 3,2007-02-27,2007-02-20,2426,Completed,AstraZeneca,NULL,"united states;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;united states;hungary;united states;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;united states;hungary;united states;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;united states;hungary;united states;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;argentina;australia;bulgaria;canada;czech republic;finland;germany;indonesia;korea, republic of;mexico;norway;philippines;poland;portugal;romania;russian federation;slovakia;south africa;thailand;united states;hungary",Drug: Esomeprazole 40 mg;Drug: Esomeprazole 20 mg;Drug: Placebo;Drug: Esomeprazole 40 mg;Drug: Esomeprazole 20 mg;Drug: Placebo;Drug: Esomeprazole 40 mg;Drug: Esomeprazole 20 mg;Drug: Placebo;Drug: Esomeprazole 40 mg;Drug: Esomeprazole 20 mg;Drug: Placebo,"
Inclusion Criteria:
- Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the
following (a-e):
- Aged =65 years.
- Aged =18 years and with a documented history of uncomplicated peptic ulcer(s).
- Aged =60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior
to randomization).
- Aged =60 years and with stable coronary artery disease.
- Aged =60 years and with complaints of upper gastrointestinal (GI) symptoms that, as
judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the
finding of =5 gastric and/or duodenal erosions at the baseline endoscopy.
Exclusion Criteria:
- Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
- Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
- History of peptic ulcer complications such as clinically significant bleeding and/or
perforation.
;
Inclusion Criteria:
- Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the
following (a-e):
- Aged =65 years.
- Aged =18 years and with a documented history of uncomplicated peptic ulcer(s).
- Aged =60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior
to randomization).
- Aged =60 years and with stable coronary artery disease.
- Aged =60 years and with complaints of upper gastrointestinal (GI) symptoms that, as
judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the
finding of =5 gastric and/or duodenal erosions at the baseline endoscopy.
Exclusion Criteria:
- Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
- Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
- History of peptic ulcer complications such as clinically significant bleeding and/or
perforation.
;
Inclusion Criteria:
- Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the
following (a-e):
- Aged =65 years.
- Aged =18 years and with a documented history of uncomplicated peptic ulcer(s).
- Aged =60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior
to randomization).
- Aged =60 years and with stable coronary artery disease.
- Aged =60 years and with complaints of upper gastrointestinal (GI) symptoms that, as
judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the
finding of =5 gastric and/or duodenal erosions at the baseline endoscopy.
Exclusion Criteria:
- Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
- Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
- History of peptic ulcer complications such as clinically significant bleeding and/or
perforation.
;
Inclusion Criteria:
- Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the
following (a-e):
- Aged =65 years.
- Aged =18 years and with a documented history of uncomplicated peptic ulcer(s).
- Aged =60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior
to randomization).
- Aged =60 years and with stable coronary artery disease.
- Aged =60 years and with complaints of upper gastrointestinal (GI) symptoms that, as
judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the
finding of =5 gastric and/or duodenal erosions at the baseline endoscopy.
Exclusion Criteria:
- Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
- Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
- History of peptic ulcer complications such as clinically significant bleeding and/or
perforation.
",NULL,Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).;Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).,Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.;Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.;Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.;Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.;Number of Participants With Gastric and/or Duodenal Erosions.,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-02-28,2007-02-27,2007-02-27,2426,Interventional,FALSE,FALSE,TRUE,NA,FALSE,TRUE,FALSE,FALSE,NA,FALSE,2007,2012-07-12,TRUE,FALSE,TRUE
15095,NCT00654719,NA,NCT00654719,NCT: 2008-04-03 ICTRP: 2008-04-03 DRKS: NA,1,1,NA,2,0,NA,"Cutpoint for inclusion changed from >= 3 to ""with stable HF New
York Heart Association (NYHA) functional class II–IV"".",2,1,NA,3,1,"no AM, no metric",3,1,"no AM, no metric",NCT: Actual 29 ICTRP: 29 DRKS: NA,29,1,1,2,1,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)","Called ""Double-blind"" but may be quadruple blind based on described details",ok,1,NA,ganzer Artikel,https://doi.org/10.1007/s13539-010-0008-0,NA,2008-04-09,NA,2001-04-30,2002-02-28,Interventional,Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia,The Influence of Enteral Nutrition on Functional Status and Inflammatory Activation in Patients With Congestive Heart Failure and Cardiac Cachexia.,Completed,Phase 2,29,Actual,National Heart and Lung Institute,Weight (kg);Quality of Life,"Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA);Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA);Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6;Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein;Left ventricular ejection fraction as assessed by echocardiography;Exercise testing using spiroergometry",372/2000,Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia,The Influence of Enteral Nutrition on Functional Status and Inflammatory Activation in Patients With Congestive Heart Failure and Cardiac Cachexia.,NULL,NULL,Interventional,"Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2,2008-04-03,2001-04-20,29,Completed,National Heart and Lung Institute,Nutricia Research Fundation,germany;poland;germany;poland,Dietary Supplement: NutriDrink;Dietary Supplement: Placebo,"
Inclusion Criteria:
- Signing of informed consent,
- Patient with either gender with actual signs or symptoms of congestive heart failure
of any origin with NYHA class no less then III,
- Presence of cardiac cachexia as defined above,
- Duration of symptoms of congestive heart failure of at least 6 months,
- Ejection fraction assessed by echocardiography =30%,
- Nutritional support will be offered solely to patients with their pharmacological
treatment firmly established for at least 30 days.
Exclusion Criteria:
- Acute decompensation with clinically evident pulmonary or abdominal congestion,
- Any situation (apart from congestive heart failure) that may affect absorption of
nutrients from the gut,
- Presence of active gastritis or ulcer,
- Presence of cancer,
- Presence of thyreotoxicosis,
- Type I diabetes mellitus,
- Pancreatic insufficiency,
- Treatment with ß-blockers,
- Clinically relevant liver disease with significantly elevated enzymes (ALAT or AspAT
or ALP 4 times above normal according to local norms),
- Body mass index > 25,
- unstable angina pectoris or other acute coronary syndromes within last three months,
- Participation in any other studies,
- Signs of uncooperative attitude,
- Known HIV virus infection,
",NULL,Weight (kg);Quality of Life,"Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA);Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA);Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6;Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein;Left ventricular ejection fraction as assessed by echocardiography;Exercise testing using spiroergometry",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-04-30,2008-04-03,2008-04-03,29,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2008-04-03,TRUE,FALSE,FALSE
16925,NCT00356096,NA,NCT00356096,NCT: 2006-07-24 ICTRP: 2006-07-24 DRKS: NA,1,1,NA,2,1,NA,Exclusion criteria more specific in register. Inlcusion identical,2,1,Information from title,4,1,no AM,3,1,"no AM, no metric",NCT: Actual 404 ICTRP: 404 DRKS: NA,404,1,1,2,1,Information on blinding only in title,Double-blind,Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1016/j.sleep.2010.08.005,NA,2006-07-25,NA,2006-07-31,NA,Interventional,Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances,"A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances",Completed,Phase 4,404,Actual,Boehringer Ingelheim,"The primary endpoint is the change from baseline after 12 weeks of treatment in: IRLS total score, IRLS item 10 score and BDI-II total score","The following endpoints will be analysed: CGI-I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate",248.604,Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances,"A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances",,,Interventional,"Intervention Model: Parallel Assignment, Primary Purpose: Treatment",Phase 4,2006-07-24,2006-07-20,404,Completed,Boehringer Ingelheim,NULL,"finland;france;germany;ireland;italy;korea, republic of;spain;sweden;united kingdom;finland;france;germany;ireland;italy;korea, republic of;spain;sweden;united kingdom",Drug: pramipexole,"
Inclusion Criteria:
1. Written informed consent consistent with ICH-GCP and local IRB/IEC requirements
obtained prior to any study procedures being performed and the ability and
willingness to comply with study treatment regimen and to attend study assessments.
2. Male or female out-patients aged 18-80 years.
3. Diagnosis of idiopathic RLS according to the clinical RLS criteria of the IRLSSG
[P03-03355]. All four criteria must be present to fulfil the diagnosis
of RLS:
An urge to move the legs, usually accompanied or caused by uncomfortable and
unpleasant sensations in the legs. (Sometimes the urge to move is present without the
uncomfortable sensations and sometimes the arms or other body parts are involved in
addition to the legs) The urge to move or unpleasant sensations begin or worsen
during periods of rest or inactivity such as lying or sitting The urge to move or
unpleasant sensations are partially or totally relieved by movement, such as walking
or stretching, at least as long as the activity continues The urge to move or
unpleasant sensations are worse in the evening or night than during the day or only
occur in the evening or night. (When symptoms are very severe, the worsening at night
may not be noticeable but must have been previously present).
4. RLS symptoms present at least 2 to 3 days per week during the last 3 months prior to
baseline (Visit 2).
5. In addition all of the following must be demonstrated at Visit 2 (baseline):
IRLS total score >15 A score of >=2 for item 10 of the IRLS rating scale
Exclusion Criteria:
1. Women of child-bearing potential who do not use an adequate method of contraception
2. Any women of child-bearing potential not having negative pregnancy test at screening
3. Breastfeeding women
4. Concomitant or previous pharmacologic therapy for RLS
5. All treatment less than 14 days before baseline or concomitant treatment with
medication or dietary supplements, which could significantly influence RLS symptoms
6. Withdrawal symptoms of any medication must not be present at baseline
7. Previous pramipexole non-responders in other indications than RLS.
8. Hypersensitivity to pramipexole or any other component of the investigational product
9. Diagnosis of diabetes mellitus requiring insulin
10. Any of the following laboratory results at screening: clinically significant
abnormalities at the investigatos discretion; Hb below lower limit of normal
11. Clinically significant renal disease at screening
12. Clinically significant hepatic disease at screening
13. Serum ferritin <10 ng/mL at screening.
14. History of/or malignant melanoma.
15. History of/or clinically significant vision abnormalities
16. History of/or any other sleep disorder
17. History of/or major depressive disorder or any psychotic disorder, mental disorders
or any present Axis I psychiatric disorder according to DSM IV requiring any medical
therapy, or BDI-II total score >28
18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute
suicidal tendency according to the investigators opinion
19. History of/or alcohol abuse or drug addiction within the last 2 years before
screening
20. Patients on a shift-work-schedule or otherwise unable to follow a regular sleep-wake
cycle
21. Participation in an investigational drug study within one month prior to the start of
this study
22. Patients with any clinically significant conditions that in the opinion of the
investigator
",NULL,"The primary endpoint is the change from baseline after 12 weeks of treatment in: IRLS total score, IRLS item 10 score and BDI-II total score","The following endpoints will be analysed: CGI-I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-07-31,2006-07-24,2006-07-24,404,Interventional,FALSE,FALSE,TRUE,NA,FALSE,TRUE,FALSE,FALSE,NA,FALSE,2006,2012-05-18,TRUE,FALSE,TRUE
26384,NCT01650805,DRKS00005165,DRKS00005165,NCT: NA ICTRP: 2013-08-06 DRKS: 2013-08-06,1,1,NA,2,1,r,Criteria more specific in register,2,1,NA,5,1,NA,5,1,NA,NCT: NA ICTRP: 528 DRKS: [---]* 528,307,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,ganzer Artikel,https://doi.org/10.1016/s1470-2045(16)00080-2,NA,2012-07-26,NA,2012-06-30,2013-10-31,Interventional,Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC),"A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase",Terminated,Phase 3,307,Actual,Ariad Pharmaceuticals,Major Molecular Response (MMR) Rate at 12 Months,MMR Rate;<10% BCR-ABL^IS Rate;Complete Cytogenetic Response (CCyR) Rate;Progression-free Survival;Overall Survival,AP24534-12-301,Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC),"A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase",NULL,NULL,Interventional,,Phase 3,2012-07-18,2012-06-20,307,Terminated,Ariad Pharmaceuticals,NULL,"united states;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;united states;united states;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;united states;united states;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;united states;united states;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;australia;austria;belgium;canada;czech republic;finland;france;germany;hong kong;italy;korea, republic of;netherlands;new zealand;poland;portugal;puerto rico;singapore;slovakia;spain;sweden;switzerland;taiwan;united kingdom;united states",Drug: ponatinib;Drug: imatinib (Gleevec/ Glivec);Drug: ponatinib;Drug: imatinib (Gleevec/ Glivec);Drug: ponatinib;Drug: imatinib (Gleevec/ Glivec);Drug: ponatinib;Drug: imatinib (Gleevec/ Glivec),"
Inclusion Criteria:
1. CP CML within 6 months of diagnosis
- CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus
promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) =100
× 10^9/L platelets (=100,000/mm^3); (v) No evidence of extramedullary disease
except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML
2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22)
Philadelphia chromosome
- (a)Variant translocations are only allowed provided they are assessable for
cytogenetic response utilizing conventional cytogenetic techniques; (b)
Conventional chromosome banding must be performed; AND (c) A minimum of 20
metaphases must be assessable at entry
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
4. Adequate hepatic function as defined by the following criteria:
(a) Total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert's
syndrome; (b) Alanine aminotransferase (ALT) =2.5 × ULN; AND (c) Aspartate
aminotransferase (AST) =2.5 × ULN
5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
6. Adequate pancreatic function as defined by serum lipase and amylase =1.5 × ULN
Exclusion Criteria:
1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or
radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically
including, but not restricted to:
1. Myocardial infarction, within 6 months prior to randomization
2. Unstable angina within 6 months prior to randomization
3. Congestive heart failure within 6 months prior to randomization
4. History of clinically significant (as determined by the treating physician)
atrial arrhythmia or any ventricular arrhythmia
5. Any history of ventricular arrhythmia
6. Cerebrovascular accident or transient ischemic attack within 6 months prior to
randomization
7. Any history of peripheral arterial occlusive disease requiring revascularization
8. Any history of venous thromboembolism including deep venous thrombosis or
pulmonary embolism
11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg).
Patients with hypertension should be under treatment on study entry to effect blood
pressure control
12. Taking medications that are known to be associated with Torsades de Pointes
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is
considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not required in the
absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary malignancy within 3
years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug
;
Inclusion Criteria:
1. CP CML within 6 months of diagnosis
- CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus
promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) =100
× 10^9/L platelets (=100,000/mm^3); (v) No evidence of extramedullary disease
except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML
2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22)
Philadelphia chromosome
- (a)Variant translocations are only allowed provided they are assessable for
cytogenetic response utilizing conventional cytogenetic techniques; (b)
Conventional chromosome banding must be performed; AND (c) A minimum of 20
metaphases must be assessable at entry
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
4. Adequate hepatic function as defined by the following criteria:
(a) Total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert's
syndrome; (b) Alanine aminotransferase (ALT) =2.5 × ULN; AND (c) Aspartate
aminotransferase (AST) =2.5 × ULN
5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
6. Adequate pancreatic function as defined by serum lipase and amylase =1.5 × ULN
Exclusion Criteria:
1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or
radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically
including, but not restricted to:
1. Myocardial infarction, within 6 months prior to randomization
2. Unstable angina within 6 months prior to randomization
3. Congestive heart failure within 6 months prior to randomization
4. History of clinically significant (as determined by the treating physician)
atrial arrhythmia or any ventricular arrhythmia
5. Any history of ventricular arrhythmia
6. Cerebrovascular accident or transient ischemic attack within 6 months prior to
randomization
7. Any history of peripheral arterial occlusive disease requiring revascularization
8. Any history of venous thromboembolism including deep venous thrombosis or
pulmonary embolism
11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg).
Patients with hypertension should be under treatment on study entry to effect blood
pressure control
12. Taking medications that are known to be associated with Torsades de Pointes
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is
considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not required in the
absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary malignancy within 3
years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug
;
Inclusion Criteria:
1. CP CML within 6 months of diagnosis
- CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus
promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) =100
× 10^9/L platelets (=100,000/mm^3); (v) No evidence of extramedullary disease
except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML
2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22)
Philadelphia chromosome
- (a)Variant translocations are only allowed provided they are assessable for
cytogenetic response utilizing conventional cytogenetic techniques; (b)
Conventional chromosome banding must be performed; AND (c) A minimum of 20
metaphases must be assessable at entry
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
4. Adequate hepatic function as defined by the following criteria:
(a) Total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert's
syndrome; (b) Alanine aminotransferase (ALT) =2.5 × ULN; AND (c) Aspartate
aminotransferase (AST) =2.5 × ULN
5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
6. Adequate pancreatic function as defined by serum lipase and amylase =1.5 × ULN
Exclusion Criteria:
1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or
radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically
including, but not restricted to:
1. Myocardial infarction, within 6 months prior to randomization
2. Unstable angina within 6 months prior to randomization
3. Congestive heart failure within 6 months prior to randomization
4. History of clinically significant (as determined by the treating physician)
atrial arrhythmia or any ventricular arrhythmia
5. Any history of ventricular arrhythmia
6. Cerebrovascular accident or transient ischemic attack within 6 months prior to
randomization
7. Any history of peripheral arterial occlusive disease requiring revascularization
8. Any history of venous thromboembolism including deep venous thrombosis or
pulmonary embolism
11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg).
Patients with hypertension should be under treatment on study entry to effect blood
pressure control
12. Taking medications that are known to be associated with Torsades de Pointes
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is
considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not required in the
absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary malignancy within 3
years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug
;
Inclusion Criteria:
1. CP CML within 6 months of diagnosis
- CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus
promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv) =100
× 10^9/L platelets (=100,000/mm^3); (v) No evidence of extramedullary disease
except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or BP-CML
2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22)
Philadelphia chromosome
- (a)Variant translocations are only allowed provided they are assessable for
cytogenetic response utilizing conventional cytogenetic techniques; (b)
Conventional chromosome banding must be performed; AND (c) A minimum of 20
metaphases must be assessable at entry
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
4. Adequate hepatic function as defined by the following criteria:
(a) Total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert's
syndrome; (b) Alanine aminotransferase (ALT) =2.5 × ULN; AND (c) Aspartate
aminotransferase (AST) =2.5 × ULN
5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
6. Adequate pancreatic function as defined by serum lipase and amylase =1.5 × ULN
Exclusion Criteria:
1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or
radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically
including, but not restricted to:
1. Myocardial infarction, within 6 months prior to randomization
2. Unstable angina within 6 months prior to randomization
3. Congestive heart failure within 6 months prior to randomization
4. History of clinically significant (as determined by the treating physician)
atrial arrhythmia or any ventricular arrhythmia
5. Any history of ventricular arrhythmia
6. Cerebrovascular accident or transient ischemic attack within 6 months prior to
randomization
7. Any history of peripheral arterial occlusive disease requiring revascularization
8. Any history of venous thromboembolism including deep venous thrombosis or
pulmonary embolism
11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg).
Patients with hypertension should be under treatment on study entry to effect blood
pressure control
12. Taking medications that are known to be associated with Torsades de Pointes
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is
considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not required in the
absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary malignancy within 3
years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug
",NULL,Major Molecular Response (MMR) Rate at 12 Months;Major Molecular Response (MMR) Rate at 12 Months,MMR Rate;<10% BCR-ABL^IS Rate;Complete Cytogenetic Response (CCyR) Rate;Progression-free Survival;Overall Survival,NCT01650805; AP24534-12-301,2013-08-06,no,Chronic Myeloid Leukemia; Chronic myeloid leukaemia,Arm 1 Drug: ponatinib; Arm 2 Drug: imatinib (Gleevec/ Glivec),Interventional,Randomized controlled trial,Open (masking not used),Active control,Parallel,III,- Major Molecular response (MMR) rate; time frame: 12 months after first dose; To compare the efficacy of ponatinib with imatinib as measured by major molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
,"- MMR rate; time frame: 5 years after first dose; To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years
- <10% BCR-ABL^IS rate; time frame: 3 months after first dose; To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib
- Complete cytogenetic response (CCyR) rate; time frame: 12 months after first dose; To compare, according to treatment with ponatinib versus imatinib, the CCyR rate at 12 months
- Progression-free survival; time frame: Up to 8 years after the last patient's first dose; To compare, according to treatment with ponatinib versus imatinib, progression-free survival
- Overall survival; time frame: Up to 8 years after the last patient's first dose; To compare, according to treatment with ponatinib versus imatinib, overall survival
","United States; Australia; Austria; Belgium; Canada; Czech Republic; Finland; France; Germany; Hong Kong; Italy; Korea, Republic of; Netherlands; New Zealand; Poland; Portugal; Puerto Rico; Singapore; Slovakia; Spain",[---]* Aachen; [---]* Berlin; [---]* Dresden; [---]* Freiburg; [---]* Hamburg; [---]* Jena; [---]* Koln; [---]* Mannheim; [---]* Munchen,2012-06-30,NA,528,NA,"1. CP CML within 6 months of diagnosis
- CP-CML will be defined by (i) <15% blasts in bone marrow; (ii) <30% blasts plus
promyelocytes in bone marrow; (iii) <20% basophils in peripheral blood; (iv)
≥100 × 10^9/L platelets (≥100,000/mm^3); (v) No evidence of extramedullary
disease except hepatosplenomegaly; AND (vi) No prior diagnosis of AP-CML or
BP-CML
2. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence of the t(9;22)
Philadelphia chromosome
- (a)Variant translocations are only allowed provided they are assessable for
cytogenetic response utilizing conventional cytogenetic techniques; (b)
Conventional chromosome banding must be performed; AND (c) A minimum of 20
metaphases must be assessable at entry
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
4. Adequate hepatic function as defined by the following criteria:
(a) Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless due to Gilbert's
syndrome; (b) Alanine aminotransferase (ALT) ≤2.5 × ULN; AND (c) Aspartate
aminotransferase (AST) ≤2.5 × ULN
5. Adequate renal function as defined as defined by serum creatinine <1.5 x ULN
6. Adequate pancreatic function as defined by serum lipase and amylase ≤1.5 × ULN
","1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental therapy, or
radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Clinically significant, uncontrolled, or active cardiovascular disease, specifically
including, but not restricted to:
1. Myocardial infarction, within 6 months prior to randomization
2. Unstable angina within 6 months prior to randomization
3. Congestive heart failure within 6 months prior to randomization
4. History of clinically significant (as determined by the treating physician)
atrial arrhythmia or any ventricular arrhythmia
5. Any history of ventricular arrhythmia
6. Cerebrovascular accident or transient ischemic attack within 6 months prior to
randomization
7. Any history of peripheral arterial occlusive disease requiring revascularization
8. Any history of venous thromboembolism including deep venous thrombosis or
pulmonary embolism
11. Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg).
Patients with hypertension should be under treatment on study entry to effect blood
pressure control
12. Taking medications that are known to be associated with Torsades de Pointes
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics is
considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not required in the
absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary malignancy within 3
years prior to entry (except for non-melanoma skin cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would compromise
patient safety or interfere with the evaluation of the drug
","A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase",Recruiting stopped after recruiting started ,Ariad Pharmaceuticals,NA,Arm 1 Drug: ponatinib; Arm 2 Drug: imatinib (Gleevec/ Glivec),2012-06-30,2012-07-18,2012-07-18,307,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2012,2014-11-05,TRUE,TRUE,TRUE
16489,NCT00420121,NA,NCT00420121,NCT: 2007-01-08 ICTRP: 2007-01-08 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,4,NA,no AM,NA,NA,NA,NCT: Anticipated 300 ICTRP: 300 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,Outcome and purpose of this observational study missing,kein Artikel,NA,NA,2007-01-09,NA,2007-01-31,2019-12-31,Observational,European Society of Cutaneous Lupus Erythematosus (EUSCLE),European Society of Cutaneous Lupus Erythematosus,Unknown status,NA,300,Anticipated,European Society of Cutaneous Lupus Erythematosus e.V.,Activity and Damage of Skin Lesions in Patients with Cutaneous Lupus Erythematosus measured by the RCLASI Activity and Damage Score.,,2742-2,European Society of Cutaneous Lupus Erythematosus (EUSCLE),European Society of Cutaneous Lupus Erythematosus,;;;;,;;;;,Observational,,N/A,2007-01-08,2007-01-20,300,Enrolling by invitation,European Society of Cutaneous Lupus Erythematosus e.V.,NULL,germany;germany;germany;germany;germany,Procedure: laboratory analysis;Procedure: laboratory analysis;Procedure: laboratory analysis;Procedure: laboratory analysis,
Inclusion Criteria:
- systemic or cutaneous lupus erythematosus confirmed by histological analysis
- written informed consent available prior to any study-procedures
Exclusion Criteria:
- patients with conditions that are contrary to the above mentioned criteria
;
Inclusion Criteria:
- systemic or cutaneous lupus erythematosus confirmed by histological analysis
- written informed consent available prior to any study-procedures
Exclusion Criteria:
- patients with conditions that are contrary to the above mentioned criteria
;
Inclusion Criteria:
- systemic or cutaneous lupus erythematosus confirmed by histological analysis
- written informed consent available prior to any study-procedures
Exclusion Criteria:
- patients with conditions that are contrary to the above mentioned criteria
;
Inclusion Criteria:
- systemic or cutaneous lupus erythematosus confirmed by histological analysis
- written informed consent available prior to any study-procedures
Exclusion Criteria:
- patients with conditions that are contrary to the above mentioned criteria
,NULL,Activity and Damage of Skin Lesions in Patients with Cutaneous Lupus Erythematosus measured by the RCLASI Activity and Damage Score.;Activity and Damage of Skin Lesions in Patients with Cutaneous Lupus Erythematosus measured by the RCLASI Activity and Damage Score.;Activity and Damage of Skin Lesions in Patients with Cutaneous Lupus Erythematosus measured by the RCLASI Activity and Damage Score.,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-01-31,2007-01-08,2007-01-08,300,Observational,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,2017-02-07,TRUE,FALSE,FALSE
13301,NCT00962559,NA,NCT00962559,NCT: 2009-08-19 ICTRP: 2009-08-19 DRKS: NA,1,1,NA,2,1,a,Inclusion criteria more specific in paper,NA,NA,NA,2,1,"no AM, no metric, no measure",NA,NA,NA,NCT: Anticipated 26 ICTRP: 26 DRKS: NA,26,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1007/s11102-011-0357-5,NA,2009-08-20,NA,2008-02-29,2010-02-28,Observational,Hypopituitarism After Aneurismal Subarachnoid Hemorrhage,Endocrine and Neuropsychological Changes After Aneurismal Subarachnoid Hemorrhage.,Completed,NA,26,Anticipated,Universitätsmedizin Mannheim,hypopituitarism of any degree,,aSAH and Hypopituitarism 0815,Hypopituitarism After Aneurismal Subarachnoid Hemorrhage,Endocrine and Neuropsychological Changes After Aneurismal Subarachnoid Hemorrhage.,NULL,NULL,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2009-08-19,2008-02-20,26,Completed,Universitätsmedizin Mannheim,NULL,germany,NULL,"
Inclusion Criteria:
- aSAH grade I-IV Hunt und Hess
- bleeding CCT Fisher grade 3-4
- therapy within 48h after aSAH
- preoperative angiography as well as control angiography
- Glasgow Outcome Scale 4 to 5 after therapy
Exclusion Criteria:
- known intra-, peri- or suprasellar neoplasia
- preexisting hypopituitarism of any degree
- previous hormonal substitution
- previous radiation
- for the neuropsychological examination: difficulties with German language
",NULL,hypopituitarism of any degree,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-02-29,2009-08-19,2009-08-19,26,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2008,2010-02-16,TRUE,FALSE,FALSE
18161,NCT00153998,NA,NCT00153998,NCT: 2005-09-08 ICTRP: 2005-09-08 DRKS: NA,1,1,NA,2,1,r,Criteria more specific in register,2,1,NA,3,1,"no AM, no time frame",4,1,no time frame,NCT: Actual 135 ICTRP: 135 DRKS: NA,114,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/s1470-2045(09)70330-4,NA,2005-09-12,NA,2004-11-30,NA,Interventional,Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM),"Open, Randomized, Multicenter, Randomized Phase II Trial Comparing the Combination of Cetuximab With Oxaliplatin/5-FU/FA Versus the Combination of Cetuximab With Irinotecan/5-FU/FA as Neoadjuvant Treatment in Patients With Non-Resectable Colorectal Liver Metastases",Completed,Phase 2,135,Actual,Technische Universität Dresden,"Tumor response, defined as partial and complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) - criteria in the intention-to-treat [ITT-] population",Rate of R0 liver resection (ITT- population);Progression free survival (ITT- population);Disease free survival after resection (ITT- population);Overall survival (ITT- population);Safety (all patients that received any study drug);Molecular predictive markers for response and toxicity,CELIM,Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM),"Open, Randomized, Multicenter, Randomized Phase II Trial Comparing the Combination of Cetuximab With Oxaliplatin/5-FU/FA Versus the Combination of Cetuximab With Irinotecan/5-FU/FA as Neoadjuvant Treatment in Patients With Non-Resectable Colorectal Liver Metastases",;,;,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 2,2005-09-08,2004-11-20,135,Completed,Technische Universität Dresden,NULL,austria;germany;austria;germany,Drug: Cetuximab;Procedure: Liver resection;Drug: Cetuximab and FOLFIRI;Drug: Cetuximab and FOLFOX,"
Inclusion Criteria:
- Patients with non-resectable, histologically confirmed, synchronous or metachronous
colorectal liver metastases. Patients with non-resectable metastases are defined as;
patients with five or more liver metastases; and/or patients with liver metastases
that are technically non-resectable (local surgeon in cooperation with local
radiologist will define non-resectability on the basis of remaining functional liver
tissue, infiltration of all liver veins, infiltration of both liver arteries, both
portal branches or both bile ducts).
- Patients with simultaneous liver metastases are eligible, if the primary tumor has
been resected at least 1 month prior to chemotherapy.
- Karnofsky Performance Status = 80
- Informed consent
- Adequate bone marrow function, liver and renal function (neutrophils > 1.5 x 10^9/l;
thrombocytes > 100 x 10^9/l; hemoglobin > 8.0 g/l; bilirubin = 1.5 x upper limit of
normal [ULN] and not increasing more than 25% within the last 4 weeks; ALAT and ASAT
< 5 x UNL; serum creatinine = 1.5 x UNL)
- Age = 18 years
Exclusion Criteria:
- Any evidence of extrahepatic metastases, lymph node metastases and primary tumor
recurrence
- Prior chemotherapy (except adjuvant chemotherapy with an interval of = 6 months)
- Previous exposure to EGFR (epidermal growth factor receptor)-targeting therapy
- Radiotherapy or major abdominal or thoracic surgery (excluding diagnostic biopsy or
port implantation) = 4 weeks before study entry
- Concurrent systemic immune therapy, chemotherapy, or hormone therapy
- Investigational agents or participation in clinical trials within 30 days before
start of the treatment in study
- Clinically relevant coronary disease or myocardial infarction within 12 months before
study entry
- Peripheral neuropathy > CTC grade I
- Inflammatory bowel disease
- Previous malignancy (except colorectal cancer, history of basal cell carcinoma of
skin or pre-invasive carcinoma of the cervix with adequate treatment)
- History of severe psychiatric illness
- Drug or alcohol abuse
- Breast feeding or pregnant women, no effective contraception if risk of conception
exists (male and female patients)
",NULL,"Tumor response, defined as partial and complete response according to RECIST (Response Evaluation Criteria in Solid Tumors) - criteria in the intention-to-treat [ITT-] population",Rate of R0 liver resection (ITT- population);Progression free survival (ITT- population);Disease free survival after resection (ITT- population);Overall survival (ITT- population);Safety (all patients that received any study drug);Molecular predictive markers for response and toxicity,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-11-30,2005-09-08,2005-09-08,135,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2004,2009-02-26,TRUE,FALSE,FALSE
6770,NCT02108392,NA,NCT02108392,NCT: 2014-04-01 ICTRP: 2014-04-01 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure",2,NA,"no AM, no measure, no type of outcome (insufficient for checking)",NCT: Anticipated 100 ICTRP: 100 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2014-04-09,NA,2014-01-31,2018-12-31,Observational,Characterization of Pseudoxanthoma Elasticum,Characterization of Patients With Pseudoxanthoma Elasticum,Unknown status,NA,100,Anticipated,"University Hospital, Bonn",Ocular phenotype,Biomarkers in PXE,pending,Characterization of Pseudoxanthoma Elasticum,Characterization of Patients With Pseudoxanthoma Elasticum,,,Observational,,,2014-04-01,2014-01-20,100,Unknown status,"University Hospital, Bonn",NULL,germany,NULL,
Inclusion Criteria:
- Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing
,NULL,Ocular phenotype,Biomarkers in PXE,NCT02108392; pending,2015-05-08,yes,Pseudoxanthoma Elasticum; Other specified congenital malformations of skin,,Non-interventional,NA,NA,NA,NA,N/A,- Ocular phenotype; time frame: patients will be followed longitudinally with an expected 1-year average interval between visits; Patients are investigated using a multimodal imaging approach and visual function testing.
,- Biomarkers in PXE; time frame: 1 day (first visit); Potential systemic biomarkers are investigated by collecting blood samples of PXE patients
,Germany,[---]* Bonn,2014-01-31,NA,100,NA,Inclusion Criteria:
- Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing
,NA,Characterization of Patients With Pseudoxanthoma Elasticum,Recruiting ongoing,"University Hospital, Bonn; Department of Ophthalmology, University of Bonn; [---]*",[---]*; [---]*; martin.gliem@ukb.uni-bonn.de,,2014-01-31,2014-04-01,2014-04-01,100,Observational,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2014,2018-06-18,TRUE,TRUE,FALSE
16126,NCT00472550,NA,NCT00472550,NCT: 2007-05-10 ICTRP: 2007-05-10 DRKS: NA,1,1,NA,2,1,r,Criteria more specific in register,2,1,NA,4,1,no AM,4,1,no AM,NCT: Actual 16 ICTRP: 16 DRKS: NA,16,1,1,2,1,NA,Double,Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1080/00365520802105110,NA,2007-05-11,NA,2006-01-31,2006-11-30,Interventional,Esomeprazole and Gastric Emptying of Beer,"Effects of Esomeprazole on Gastric Emptying of Alcoholic Beverages, Blood Alcohol Concentrations, Gastroesophageal Reflux and Release of Some Gastrointestinal Hormones in Healthy Volunteers",Completed,Phase 4,16,Actual,Heidelberg University,"Gastric emptying time, gastroesophageal reflux","blood ethanol concentration, CCK-levels, gastrin-levels, dyspeptic symptoms",Mannheim-Eso-001,Esomeprazole and Gastric Emptying of Beer,"Effects of Esomeprazole on Gastric Emptying of Alcoholic Beverages, Blood Alcohol Concentrations, Gastroesophageal Reflux and Release of Some Gastrointestinal Hormones in Healthy Volunteers",,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 4,2007-05-10,2006-01-20,16,Completed,Heidelberg University,NULL,germany,Drug: esomeprazole 20 mg,"
Inclusion Criteria:
- Male, non-smoking volunteers without regular medication or regular alcohol
consumption will be included.
- Before inclusion blood will be drawn and the following blood count, liver, pancreas,
kidney, thyroid and coagulation parameters will be examined:
- Creatinine (0.5 – 1.3 mg/dl),
- Alc. Phosphatase (38 - 126 U/l),
- GGT (0 - 85 U/l),
- ALAT (0 - 50 U/l),
- ASAT (0 - 37 U/l),
- LDH (0 - 248 U/l),
- Cholinesterase (>7000 U/l),
- Amylase (25 - 130 U/l),
- Lipase (114 - 300 U/l),
- Leucocytes (3,5 – 11.0 10E9/L),
- Erythrocytes (4.0 – 5.9 10E12/L),
- Hb (12.0 – 17.5 g/dl),
- Ht (33 – 50%),
- Platelets (145 – 440 10E9/L),
- CrP (< 10 mg/l),
- TSH (0.4 - 5.0 mE/l),
- fT4 (6 - 23 pmol/l),
- INR (0.75 – 1.30),
- PTT (15.0 – 33.0 sec.)
The results have to be within the physiological range (as given in parenthesis).
Moreover, volunteers have mentally to be able to understand the explanations concerning
the study and follow to the instructions of the investigator.
Exclusion Criteria:
- Any acute or chronic disease,
- Heartburn more than once weekly,
- Alcohol consumption of more than 50 g ethanol-equivalent per week,
- Smoking,
- Known hypersensitivity against esomeprazole,
- Benzimidazole or other ingredients of the medication,
- Fructose-intolerance,
- Glucose-galactose-malabsorption or saccharase-isomaltase-deficiency.
",NULL,"Gastric emptying time, gastroesophageal reflux","blood ethanol concentration, CCK-levels, gastrin-levels, dyspeptic symptoms",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-01-31,2007-05-10,2007-05-10,16,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2006,2007-05-10,TRUE,FALSE,FALSE
10290,NCT01443637,NA,NCT01443637,NCT: 2011-09-28 ICTRP: 2011-09-28 DRKS: NA,1,1,NA,2,1,NA,NA,NA,NA,NA,2,1,"No AM, no metric, no measure; Outcome is time to death from all causes in paper (outcomes given in register were also assessed)",NA,NA,NA,NCT: Anticipated 50000 ICTRP: 50000 DRKS: NA,27125,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1161/ATVBAHA.114.304351,NA,2011-09-30,NA,2003-06-30,2026-01-31,Observational,COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM),COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry,Enrolling by invitation,NA,50000,Anticipated,Weill Medical College of Cornell University,Coronary and non-coronary cardiac findings by CCTA,,1310014468,COroNary CT Angiography Evaluation For Clinical Outcomes: An InteRnational Multicenter Registry (CONFIRM),COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry,,,Observational,,,2011-09-28,2003-06-20,50000,Enrolling by invitation,Weill Medical College of Cornell University,NULL,"united states;austria;canada;germany;italy;korea, republic of;switzerland;austria;canada;germany;italy;korea, republic of;switzerland;united states",NULL,
All consecutive patients at cluster sites meeting all inclusion criteria undergoing CCTA of
64-detector rows or greater will be included within the CONFIRM registry.
Inclusion Criteria:
1. Age > 18 years
2. Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of
standard of care
3. Interpretable CCTA
4. Prospective data collection for CAD risk factors.
Exclusion Criteria:
No explicit patient exclusion criteria are defined.
,NULL,Coronary and non-coronary cardiac findings by CCTA,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-06-30,2011-09-28,2011-09-28,50000,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2003,2020-12-01,TRUE,FALSE,FALSE
8547,NCT01745770,NA,NCT01745770,NCT: 2012-12-05 ICTRP: 2012-12-05 DRKS: NA,1,1,NA,2,1,a,Criteria more specific in article,2,1,NA,4,1,no measure,4,1,No AM,NCT: Actual 306 ICTRP: 306 DRKS: NA,306,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Double,worse,1,NA,ganzer Artikel,https://doi.org/10.1177%2F2050640617703842,NA,2012-12-10,NA,2013-01-31,2015-06-30,Interventional,TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC),"Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis",Completed,Phase 3,306,Actual,Dr. Falk Pharma GmbH,Rate of clinical remission,Number of stools per week;Number of bloody stools per week;Time to first resolution of clinical symptoms,SAT-25/UCA,TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC),"Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis",NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 3,2012-12-05,2013-01-20,306,Completed,Dr. Falk Pharma GmbH,NULL,germany,Drug: Mesalazine - TID 1000 mg;Drug: Mesalazine - TID 2x 500 mg,"
Inclusion Criteria:
- Signed informed consent
- Men or women aged 18 to 75 years
- Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by
endoscopy and histology
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,
diverticular disease associated colitis, microscopic colitis (i.e., collagenous
colitis and lymphocytic colitis)
- Toxic megacolon
- Screening stool positive for germs causing bowel disease
- Malabsorption syndromes
- Celiac disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
may cause diarrhoea or gastrointestinal bleeding
",NULL,Rate of clinical remission,Number of stools per week;Number of bloody stools per week;Time to first resolution of clinical symptoms,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-01-31,2012-12-05,2012-12-05,306,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,2016-05-30,TRUE,FALSE,TRUE
17398,NCT00278213,NA,NCT00278213,NCT: 2006-01-16 ICTRP: 2006-01-16 DRKS: NA,1,NA,NA,1,NA,NA,Definition/measurement of leukemia missing,1,NA,no dosages,3,NA,"Missing AM (1), definition of remission",5,NA,NA,NCT: Anticipated 17 ICTRP: 17 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2006-01-18,NA,2002-09-30,2009-12-31,Interventional,Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia,Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia,Completed,Phase 2,17,Anticipated,German CLL Study Group,Adverse effects at 2 months after treatment;Remission rate at 2 months after treatment,Overall survival at 2 months after treatment;Progression-free survival at 2 months after treatment;Remission quality at 2 months after treatment,EU-20562;T-PLL1,Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia,Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia,,,Interventional,Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2006-01-16,2002-09-20,17,Completed,German CLL Study Group,NULL,austria;germany;austria;germany,Biological: alemtuzumab;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: mitoxantrone hydrochloride,"
DISEASE CHARACTERISTICS:
- Diagnosis of T-cell chronic lymphocytic leukemia (T-CLL) or T-cell prolymphocytic
leukemia (T-PLL)
- Previously untreated disease OR patient may have received up to 2 therapies
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 6 months
- No severe organ dysfunction
- No other concurrent or previous neoplasm
- No autoimmune hemolytic anemia or thrombocytopenia
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab
",NULL,Adverse effects at 2 months after treatment;Remission rate at 2 months after treatment,Overall survival at 2 months after treatment;Progression-free survival at 2 months after treatment;Remission quality at 2 months after treatment,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-09-30,2006-01-16,2006-01-16,17,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,2018-05-09,TRUE,FALSE,FALSE
13486,NCT00929812,NA,NA,NCT: 2009-06-29 ICTRP: NA DRKS: NA,1,1,NA,2,1,r,Criteria more specific in register,2,1,NA,4,1,No AM,4,1,No AM,NCT: Actual 38 ICTRP: NA DRKS: NA,37,1,1,2,0,NA,"Triple (Participant, Care Provider, Investigator)",Double,worse,1,NA,ganzer Artikel,https://doi.org/10.1210/jc.2013-1635,NA,2009-06-30,NA,2006-06-30,2009-12-31,Interventional,Glucagon Modulation of Ghrelin Secretion,The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion,Unknown status,Phase 3,38,Actual,"Charite University, Berlin, Germany","Changes in satiety scale, total and acylated ghrelin concentrations.","Changes in glucose, insulin and NEFA concentrations.",EudoraCT 2005-003714-15;Prüfplancode 01082005;BfArM 61-3910-4031020;EK EA4/108/05;GluGhr-study 01082005,Glucagon Modulation of Ghrelin Secretion,The Mechanisms Underlying the Glucagon-Induced Suppression of Ghrelin Secretion,,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science",Phase 3,2009-06-29,2006-06-20,38,"Active, not recruiting","Charite University, Berlin, Germany",NULL,germany,Drug: Glucagon hydrochloride (GlucaGen®);Drug: NaCl 0.9%,"
Inclusion Criteria:
- Subjects > 18 and < 60 years old.
- Patients with diabetes type 1 should fulfill the following criteria:
- ICT Insulin therapy was necessary within the first 3 months after diagnosis;
- HbA1c-Wert < 7%.
Exclusion Criteria:
- Diabetes type 1 or 2 (for the healthy group).
- Biochemical evidence of impaired hepatic or renal function.
- History of cardiovascular disease.
- Uncontrolled hypertension.
- Current inflammatory, malignant or psychiatric disease.
- Pregnancy
",NULL,"Changes in satiety scale, total and acylated ghrelin concentrations.","Changes in glucose, insulin and NEFA concentrations.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-06-30,2009-06-29,2009-06-29,38,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2006,2009-06-29,TRUE,FALSE,FALSE
13050,NCT01004198,NA,NCT01004198,NCT: 2009-10-28 ICTRP: 2009-10-28 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,No AM,4,NA,no AM,NCT: Actual 51 ICTRP: 51 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2009-10-29,NA,2009-12-31,2010-06-30,Interventional,Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients,"A Multi-center, Randomized, Double-blind, Controlled Dose-finding Study to Evaluate the Safety and Efficacy of MP4OX Treatment Plus Standard of Care in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock",Completed,Phase 2,51,Actual,Sangart,Serum lactate clearance,All-cause mortality;Ventilator-free days;ICU-free days;Hospital-free days;Sepsis-related Organ Failure Assessment (SOFA) score;Modified Denver score;Composite endpoint of Time to Complete Organ Failure Resolution (CTCOFR),TRA-204,Phase IIa Study of MP4OX in Traumatic Hemorrhagic Shock Patients,"A Multi-center, Randomized, Double-blind, Controlled Dose-finding Study to Evaluate the Safety and Efficacy of MP4OX Treatment Plus Standard of Care in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2,2009-10-28,2009-12-20,51,Completed,Sangart,NULL,france;germany;south africa;united kingdom;france;germany;south africa;united kingdom,Drug: MP4OX;Drug: MP4OX;Drug: Ringers Lactate solution,"
Inclusion Criteria:
- Adult male or female (surgically sterile or post-menopausal or confirmed not to be
pregnant)
- Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to
hemorrhagic shock (blood lactate level = 5 mmol/L; equivalent to = 45 mg/dL)
- Informed consent obtained before any study-related activities
Exclusion Criteria:
- Not expected to survive 24 hours after randomization
- Evidence of severe traumatic brain injury as defined by any one of the following:
Known non-survivable head injury or open brain injury; Glasgow Coma Score (GCS) = 3,
4 or 5, or known AIS = 5 if GCS > 5; Immediate open intracranial operation; Abnormal
physical exam indicative of severe CNS or spinal injury
- Significant ongoing uncontrolled hemorrhage where control of bleeding is not expected
within 2 hours of randomization
- Cardiac arrest prior to dosing
- Estimated time from injury to dosing > 4 hours
- Estimated time from hospital admission to randomization > 2 hours
- Known or suspected pregnancy (confirmed by urine test)
- Previous participation in this study
- Professional or ancillary personnel involved with this study
- Receipt of any investigational drug(s) within 30 days prior to study
",NULL,Serum lactate clearance,All-cause mortality;Ventilator-free days;ICU-free days;Hospital-free days;Sepsis-related Organ Failure Assessment (SOFA) score;Modified Denver score;Composite endpoint of Time to Complete Organ Failure Resolution (CTCOFR),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-12-31,2009-10-28,2009-10-28,51,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2009,2013-08-15,TRUE,FALSE,FALSE
12903,NCT01029652,NA,NA,NCT: 2009-12-09 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 230 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2009-12-10,NA,2009-12-31,2010-10-31,Interventional,Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study,"A 12 Weeks Randomized, Controlled Core Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective, Including a 12-week Double-blind Extension Study and an Open-label 48 Week Extension Study",Completed,Phase 3,230,Actual,Novartis,"Time to First New Flare;Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS);Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall);Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)","Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS);Time to Complete Resolution of Pain;Percentage of Participants With Complete Resolution of Pain;Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks;Mean Number of New Gout Flares Per Patient;SF36 Physical Function Score at Week 12;Time to First New Flare;Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study;Time to First Intake of Rescue Medication After the Last Post Baseline Flare.;Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension;Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale);Amount of Rescue Medication Taken;Percentage of Participants Who Took Rescue Medication;High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall;Physician's Global Assessment of Response to Treatment;Patient's Global Assessment of Response to Treatment;Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint;Physician's Assessment of Range of Motion of the Most Affected Joint;Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale);Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall);Flare Rate Per Year;High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab;Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab;Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab;Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale);Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab;Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab;Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab;Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab",2009-015018-23;CACZ885H2356E1;CACZ885H2356E2;CACZ885H2356,Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study,"A 12 Weeks Randomized, Controlled Core Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective, Including a 12-week Double-blind Extension Study and an Open-label 48 Week Extension Study",;;;,;;;,Interventional,,Phase 3,2009-12-09,2009-12-20,230,Completed,Novartis Pharmaceuticals,NULL,australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;turkey;australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;turkey;australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;turkey;australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;australia;belgium;canada;colombia;estonia;germany;guatemala;latvia;lithuania;mexico;norway;poland;russian federation;singapore;sweden;switzerland;ukraine;turkey,Drug: Canakinumab 150 mg;Drug: Triamcinolone acetonide 40 mg;Drug: Placebo to canakinumab;Drug: Placebo to triamcinolone acetonide;Drug: Canakinumab 150 mg;Drug: Triamcinolone acetonide 40 mg;Drug: Placebo to canakinumab;Drug: Placebo to triamcinolone acetonide;Drug: Canakinumab 150 mg;Drug: Triamcinolone acetonide 40 mg;Drug: Placebo to canakinumab;Drug: Placebo to triamcinolone acetonide;Drug: Canakinumab 150 mg;Drug: Triamcinolone acetonide 40 mg;Drug: Placebo to canakinumab;Drug: Placebo to triamcinolone acetonide,"
Core Study:
Inclusion criteria:
- Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the
classification of acute arthritis of primary gout
- Onset of current acute gout flare within 5 days prior to study entry
- Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)
- History of = 3 gout flares within the 12 months prior to study entry
- Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory
drugs (NSAIDs) and/or colchicine
Exclusion criteria:
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis
- Presence of severe renal function impairment
- Use of specified pain relief medications or biologics ( corticosteroids, narcotics,
paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis
factor inhibitor) within specified periods prior to study entry
- Live vaccinations within 3 months prior to randomization
- Requirement for administration of antibiotics against latent tuberculosis (TB)
- Refractory heart failure (Stage D)
- Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
- Any active or recurrent bacterial, fungal, or viral infection
Extension Study 1:
Inclusion Completion of the Core study. A patient was defined as completing the core study
if they completed the study up to and including visit 7.
Exclusion
- Continuation in this extension study was considered inappropriate by the treating
physician.
Extension Study 2:
Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as
completing the first extension study if they completed the study up to and including Visit
10).
Exclusion
-Continuation in this extension study was considered inappropriate by the treating
physician
Other protocol-defined inclusion-exclusion criteria applied to the core and extension
studies.
;
Core Study:
Inclusion criteria:
- Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the
classification of acute arthritis of primary gout
- Onset of current acute gout flare within 5 days prior to study entry
- Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)
- History of = 3 gout flares within the 12 months prior to study entry
- Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory
drugs (NSAIDs) and/or colchicine
Exclusion criteria:
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis
- Presence of severe renal function impairment
- Use of specified pain relief medications or biologics ( corticosteroids, narcotics,
paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis
factor inhibitor) within specified periods prior to study entry
- Live vaccinations within 3 months prior to randomization
- Requirement for administration of antibiotics against latent tuberculosis (TB)
- Refractory heart failure (Stage D)
- Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
- Any active or recurrent bacterial, fungal, or viral infection
Extension Study 1:
Inclusion Completion of the Core study. A patient was defined as completing the core study
if they completed the study up to and including visit 7.
Exclusion
- Continuation in this extension study was considered inappropriate by the treating
physician.
Extension Study 2:
Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as
completing the first extension study if they completed the study up to and including Visit
10).
Exclusion
-Continuation in this extension study was considered inappropriate by the treating
physician
Other protocol-defined inclusion-exclusion criteria applied to the core and extension
studies.
;
Core Study:
Inclusion criteria:
- Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the
classification of acute arthritis of primary gout
- Onset of current acute gout flare within 5 days prior to study entry
- Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)
- History of = 3 gout flares within the 12 months prior to study entry
- Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory
drugs (NSAIDs) and/or colchicine
Exclusion criteria:
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis
- Presence of severe renal function impairment
- Use of specified pain relief medications or biologics ( corticosteroids, narcotics,
paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis
factor inhibitor) within specified periods prior to study entry
- Live vaccinations within 3 months prior to randomization
- Requirement for administration of antibiotics against latent tuberculosis (TB)
- Refractory heart failure (Stage D)
- Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
- Any active or recurrent bacterial, fungal, or viral infection
Extension Study 1:
Inclusion Completion of the Core study. A patient was defined as completing the core study
if they completed the study up to and including visit 7.
Exclusion
- Continuation in this extension study was considered inappropriate by the treating
physician.
Extension Study 2:
Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as
completing the first extension study if they completed the study up to and including Visit
10).
Exclusion
-Continuation in this extension study was considered inappropriate by the treating
physician
Other protocol-defined inclusion-exclusion criteria applied to the core and extension
studies.
;
Core Study:
Inclusion criteria:
- Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the
classification of acute arthritis of primary gout
- Onset of current acute gout flare within 5 days prior to study entry
- Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)
- History of = 3 gout flares within the 12 months prior to study entry
- Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory
drugs (NSAIDs) and/or colchicine
Exclusion criteria:
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
acute inflammatory arthritis
- Presence of severe renal function impairment
- Use of specified pain relief medications or biologics ( corticosteroids, narcotics,
paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis
factor inhibitor) within specified periods prior to study entry
- Live vaccinations within 3 months prior to randomization
- Requirement for administration of antibiotics against latent tuberculosis (TB)
- Refractory heart failure (Stage D)
- Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
- Any active or recurrent bacterial, fungal, or viral infection
Extension Study 1:
Inclusion Completion of the Core study. A patient was defined as completing the core study
if they completed the study up to and including visit 7.
Exclusion
- Continuation in this extension study was considered inappropriate by the treating
physician.
Extension Study 2:
Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as
completing the first extension study if they completed the study up to and including Visit
10).
Exclusion
-Continuation in this extension study was considered inappropriate by the treating
physician
Other protocol-defined inclusion-exclusion criteria applied to the core and extension
studies.
",NULL,"Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall);Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall);Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS);Time to First New Flare;Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall);Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall);Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS);Time to First New Flare","Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale);Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab;Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab;Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab;Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab;Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab;Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab;High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab;Flare Rate Per Year;Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall);Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale);Physician's Assessment of Range of Motion of the Most Affected Joint;Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint;Patient's Global Assessment of Response to Treatment;Physician's Global Assessment of Response to Treatment;High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall;Percentage of Participants Who Took Rescue Medication;Amount of Rescue Medication Taken;Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale);Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension;Time to First Intake of Rescue Medication After the Last Post Baseline Flare.;Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study;Time to First New Flare;SF36 Physical Function Score at Week 12;Mean Number of New Gout Flares Per Patient;Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks;Percentage of Participants With Complete Resolution of Pain;Time to Complete Resolution of Pain;Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-12-31,2009-12-09,2009-12-09,230,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2009,2013-12-24,TRUE,FALSE,TRUE
9505,NCT01576666,NA,NCT01576666,NCT: 2012-04-10 ICTRP: 2012-04-10 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosages (dose escalation study),4,NA,no AM,5,NA,NA,NCT: Actual 120 ICTRP: 120 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2012-04-12,NA,2012-07-31,2015-04-30,Interventional,"Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors","A Phase Ib, Multi-center, Open Label, Dose Escalation Study of Oral LDE225 in Combination With BKM 120 in Patients With Advanced Solid Tumors",Completed,Phase 1,120,Actual,Novartis,Dose Limiting Toxicities,Number of Patients with Adverse Events and Serious Adverse Events;Objective response rate (ORR);Early progression rate (EPR);Plasma pharmacokinetics (PK) parameters,2011-005016-28;CLDE225X2114,"Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors","A Phase Ib, Multi-center, Open Label, Dose Escalation Study of Oral LDE225 in Combination With BKM 120 in Patients With Advanced Solid Tumors",,,Interventional,"Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label",Phase 1,2012-04-10,2012-07-20,120,Completed,Novartis Pharmaceuticals,NULL,united states;australia;belgium;canada;germany;italy;spain;united kingdom;australia;belgium;canada;germany;italy;spain;united kingdom;united states,Drug: LDE225;Drug: BKM120,"
Inclusion Criteria:
1. Male or female adult patients (> 18 years)
2. Patients with histologically/cytologically confirmed diagnosis of the following
advanced tumors that have progressed despite standard therapy or that have no
available established treatments: metastatic breast cancer, pancreatic
adenocarcinoma, metastatic CRC or recurrent GBM will be included.
3. Provision of an archival tumor sample to a Novartis designated laboratory for
molecular profiling. The tumor material submitted for these analyses may have been
obtained at any time during the course of the patient's disease.
4. Measurable disease as assessed by RECIST 1.1 for non-GBM tumors and by RANO criteria
for GBM.
5. ECOG (WHO) performance status 0-2
6. Adequate bone marrow and organ function
7. Patient is able to swallow and retain oral medication
8. Negative serum pregnancy test; non-lactating or post-menopausal women.
Exclusion Criteria:
1.Use of other investigational drugs within 30 days of enrollment or 5 half-lives of
enrollment, whichever is longer. 2.History of hypersensitivity to LDE225, BKM120 or to
drugs of similar chemical classes.
3.Patient has received previous treatment with PI3K inhibitors and/or smoothened
inhibitors.
4.Patients with recurrent GBM who have received radiotherapy within 3 months of initiating
study treatment.
5.Patients with primary CNS tumor (except recurrent GBM), uncontrolled or symptomatic CNS
metastasis. However, patients with controlled, asymptomatic or with resected CNS
metastases with no radiological evidence of disease or with stable brain metastasis with
no progression may be are eligible.
6.Patients who have neuromuscular disorders or are on concomitant treatment with drugs
that are recognized to cause rhabdomyolysis, such as HMG CoA inhibitors (statins),
clofibrate and gemfibrozil. If it is essential that the patient remains on a statin to
control hyperlipidemia, only Pravastatin may be used with extra caution.
7.Patients who require the use of warfarin (substrate of CYP2C9) cannot be enrolled as
LDE225 and BKM120 are competitive inhibitors of CYP2C9 based on in-vitro data.
8.Patient is currently being treated with drugs known to be strong inhibitors or inducers
of CYP3A4/5, which cannot be discontinued or switched to a different medication 7 days
prior to starting study treatment and for the duration of the study.
9.Patient has a score =12 on the PHQ-9 questionnaire. A normal evaluation by a
psychiatrist or psychologist can overrule this exclusion).
10.Patients who select responses of 1, 2 or 3 to question number 9 on the PHQ-9
questionnaire regarding potential for suicidal thoughts or ideation (independent of the
total score of the PHQ-9), (a normal evaluation by a psychiatrist or psychologist can
overrule this exclusion).
11.Patient has a GAD-7 mood scale score = 15, (a normal evaluation by a psychiatrist or
psychologist can overrule this exclusion) 12.Patient has a documented medical history of
or active major depression episode, bipolar disorder (I or II), obsessive compulsive
disorder, schizophrenia, a history of suicidal attempts or ideation, or homicidal ideation
(e.g. risk of doing harm to self or others) 13. Patient has =CTCAE grade 3 anxiety
14.Current medical history of the following:
- Use of a pacemaker
- History of or presence of clinically significant ventricular or atrial
tachyarrhythmia
- Clinically significant resting bradycardia (< 45 beats per minute)
- History of clinically documented myocardial infarction
- History of unstable angina pectoris
- History of known structural abnormalities (i.e. cardiomyopathy) 15.Clinically
significant cardio-vascular disease 16.Clinically significant abnormal ECG 17.Left
Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated Acquisition
(MUGA) scan or echocardiogram (ECHO) 18.Patient is currently receiving treatment with
QT prolonging medication known to have a risk to induce Torsades de Pointes, and the
treatment cannot be discontinued or switched to a different medication 7 days prior
to starting the study and for the duration of the study 19.Patients who are not
willing to apply highly effective contraception as defined by the protocol during the
study and through the duration of the study. Note: Hormonal contraception methods
(e.g. oral, injected, implanted) are not allowed as it cannot be ruled out that the
study drug decreases the effectiveness of hormonal contraception 20.Sexually active
males who are unwilling to use a condom during intercourse while taking drug and for
6 months after stopping investigational medications and agree not father a child in
this period.
21.Patients is currently receiving increasing or chronic treatment with
corticosteroids ((= the anti-inflammatory potency of 4mg dexamethasone) or another
immunosuppressive agent.
22.Patient has been treated with any hematopoietic colony-stimulating growth factors
(e.g., G-CSF, GM-CSF) = 2 weeks prior to starting study drug. Erythropoietin or
darbepoetin therapy, if initiated before enrollment, may be continued 23.Patient who
has received chemotherapy, targeted therapy or immunotherapy = 3 weeks (6 weeks for
nitrosourea, mitomycin-C or monoclonal antibodies; 1 week for hormonal anti-cancer
therapy) prior to starting study drug or who have not recovered to grade 1 or better
from related side effects of such therapy (exceptions include alopecia, bone marrow
and organ functions) 24.Patient has impairment of gastrointestinal (GI) function or
GI disease that may significantly alter the absorption of LDE225 and BKM120 (e.g.,
ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome,
or small bowel resection) 25.Patient has a known history of HIV infection (testing
not mandatory)
AMENDMENT 1 CHANGES:
Inclusion Criteria:
3. Provision of an archival tumor sample to a Novartis designated laboratory for molecular
profiling. It is accepted that it may not be possible to obtain all samples prior to
commencing study treatment. It is also accepted that it may not be possible to obtain a
sample (e.g. if sufficient sample does not exist), and in this situation inclusion of the
patient should be discussed with Novartis (as this may not make a patient ineligible).
Exclusion Criteria:
5. Patients with primary CNS tumor (except recurrent GBM), uncontrolled or symptomatic CNS
metastasis. However, patients with controlled, asymptomatic or with resected CNS
metastases with no radiological evidence of disease or with stab",NULL,Dose Limiting Toxicities,Number of Patients with Adverse Events and Serious Adverse Events;Objective response rate (ORR);Early progression rate (EPR);Plasma pharmacokinetics (PK) parameters,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-07-31,2012-04-10,2012-04-10,120,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,2020-12-16,TRUE,FALSE,FALSE
17644,NCT00240214,NA,NCT00240214,NCT: 2005-10-13 ICTRP: 2005-10-13 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,0,NA,no info,NA,NA,NA,NCT: Actual 500 ICTRP: 500 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2005-10-17,NA,2001-04-30,2008-02-29,Observational,Study Evaluating Rapamune in Patients After Kidney Transplantation,An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime,Terminated,NA,500,Actual,Wyeth is now a wholly owned subsidiary of Pfizer,NA,NA,0468E-100875,Study Evaluating Rapamune in Patients After Kidney Transplantation,An Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime,;,;,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2005-10-13,2001-04-20,500,Terminated,Wyeth is now a wholly owned subsidiary of Pfizer,NULL,germany,Drug: sirolimus,
Inclusion Criteria:
- Patients having received a renal allograft from a cadaveric or living donor with low
or moderate risk of developing acute rejection episodes.
Exclusion Criteria:
- Contraindications according to Summary of the Product Characteristics (SmPC).
,NULL,NULL,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-04-30,2005-10-13,2005-10-13,500,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2008-03-13,TRUE,FALSE,FALSE
11716,NCT01223352,NA,NCT01223352,NCT: 2010-10-12 ICTRP: 2010-10-12 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 64 ICTRP: 64 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Abstract,https://doi.org/10.1016/j.clinthera.2015.05.423,NA,2010-10-19,NA,2011-03-08,2013-08-19,Interventional,Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension,"An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension",Completed,Phase 3,64,Actual,Actelion,Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan,,AC-052-373,Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension,"An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension",;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2010-10-12,2011-03-08,64,Completed,Actelion,NULL,united states;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;united states;czech republic;united states;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;united states;czech republic;united states;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;united states;czech republic;united states;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;united states;czech republic;united states;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;australia;belarus;china;czechia;france;germany;hungary;india;israel;italy;mexico;netherlands;poland;russian federation;serbia;south africa;spain;ukraine;united states;czech republic,Drug: bosentan;Drug: bosentan;Drug: bosentan;Drug: bosentan,"
Inclusion Criteria:
1. PAH diagnosis confirmed with right heart catheterization (RHC):
- Idiopathic or heritable PAH, or
- Associated PAH persisting after complete repair of a congenital heart defect (PAH
has to be persistent for at least 6 months after surgery) or
- PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary
shunts (after global amendment dated 09 May 2012)
2. World Health Organization functional Class (WHO FC) I, II or III
3. Male or female = 3 months and < 12 years of age (maximum age at randomization is 11.5
years)
4. Body weight = 3.5 kg
5. Peripheral oxygen saturation (SpO2) = 88% (at rest, on room air)
6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase
type-5 inhibitor) if present, has to be stable for at least 3 months prior to
screening. During the study, all background treatments should remain stable
7. Signed informed consent by the parents or legal representatives
Exclusion Criteria:
1. PAH etiologies other than listed above
2. Non-stable disease status
3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled
iloprost
4. Systolic blood pressure < 80% of the lower limit of normal range
5. Aspartate aminotransferase and/or alanine aminotransferase values > 1.5 times the
upper limit of normal range.
6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
dispersible Tracleer tablet
9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life
prior to randomization, whichever is the longest:
- Glibenclamide (glyburide)
- Cyclosporin A
- Sirolimus
- Tacrolimus
- Fluconazole
- Rifampicin (rifampin)
- Ritonavir
- Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and
moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole,
diltiazem, itraconazole)
- Endothelin receptor antagonists (ERAs) other than bosentan
10. Treatment with another investigational drug within 1 month prior to randomization or
planned treatment
;
Inclusion Criteria:
1. PAH diagnosis confirmed with right heart catheterization (RHC):
- Idiopathic or heritable PAH, or
- Associated PAH persisting after complete repair of a congenital heart defect (PAH
has to be persistent for at least 6 months after surgery) or
- PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary
shunts (after global amendment dated 09 May 2012)
2. World Health Organization functional Class (WHO FC) I, II or III
3. Male or female = 3 months and < 12 years of age (maximum age at randomization is 11.5
years)
4. Body weight = 3.5 kg
5. Peripheral oxygen saturation (SpO2) = 88% (at rest, on room air)
6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase
type-5 inhibitor) if present, has to be stable for at least 3 months prior to
screening. During the study, all background treatments should remain stable
7. Signed informed consent by the parents or legal representatives
Exclusion Criteria:
1. PAH etiologies other than listed above
2. Non-stable disease status
3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled
iloprost
4. Systolic blood pressure < 80% of the lower limit of normal range
5. Aspartate aminotransferase and/or alanine aminotransferase values > 1.5 times the
upper limit of normal range.
6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
dispersible Tracleer tablet
9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life
prior to randomization, whichever is the longest:
- Glibenclamide (glyburide)
- Cyclosporin A
- Sirolimus
- Tacrolimus
- Fluconazole
- Rifampicin (rifampin)
- Ritonavir
- Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and
moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole,
diltiazem, itraconazole)
- Endothelin receptor antagonists (ERAs) other than bosentan
10. Treatment with another investigational drug within 1 month prior to randomization or
planned treatment
;
Inclusion Criteria:
1. PAH diagnosis confirmed with right heart catheterization (RHC):
- Idiopathic or heritable PAH, or
- Associated PAH persisting after complete repair of a congenital heart defect (PAH
has to be persistent for at least 6 months after surgery) or
- PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary
shunts (after global amendment dated 09 May 2012)
2. World Health Organization functional Class (WHO FC) I, II or III
3. Male or female = 3 months and < 12 years of age (maximum age at randomization is 11.5
years)
4. Body weight = 3.5 kg
5. Peripheral oxygen saturation (SpO2) = 88% (at rest, on room air)
6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase
type-5 inhibitor) if present, has to be stable for at least 3 months prior to
screening. During the study, all background treatments should remain stable
7. Signed informed consent by the parents or legal representatives
Exclusion Criteria:
1. PAH etiologies other than listed above
2. Non-stable disease status
3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled
iloprost
4. Systolic blood pressure < 80% of the lower limit of normal range
5. Aspartate aminotransferase and/or alanine aminotransferase values > 1.5 times the
upper limit of normal range.
6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
dispersible Tracleer tablet
9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life
prior to randomization, whichever is the longest:
- Glibenclamide (glyburide)
- Cyclosporin A
- Sirolimus
- Tacrolimus
- Fluconazole
- Rifampicin (rifampin)
- Ritonavir
- Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and
moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole,
diltiazem, itraconazole)
- Endothelin receptor antagonists (ERAs) other than bosentan
10. Treatment with another investigational drug within 1 month prior to randomization or
planned treatment
;
Inclusion Criteria:
1. PAH diagnosis confirmed with right heart catheterization (RHC):
- Idiopathic or heritable PAH, or
- Associated PAH persisting after complete repair of a congenital heart defect (PAH
has to be persistent for at least 6 months after surgery) or
- PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary
shunts (after global amendment dated 09 May 2012)
2. World Health Organization functional Class (WHO FC) I, II or III
3. Male or female = 3 months and < 12 years of age (maximum age at randomization is 11.5
years)
4. Body weight = 3.5 kg
5. Peripheral oxygen saturation (SpO2) = 88% (at rest, on room air)
6. Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase
type-5 inhibitor) if present, has to be stable for at least 3 months prior to
screening. During the study, all background treatments should remain stable
7. Signed informed consent by the parents or legal representatives
Exclusion Criteria:
1. PAH etiologies other than listed above
2. Non-stable disease status
3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled
iloprost
4. Systolic blood pressure < 80% of the lower limit of normal range
5. Aspartate aminotransferase and/or alanine aminotransferase values > 1.5 times the
upper limit of normal range.
6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
dispersible Tracleer tablet
9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life
prior to randomization, whichever is the longest:
- Glibenclamide (glyburide)
- Cyclosporin A
- Sirolimus
- Tacrolimus
- Fluconazole
- Rifampicin (rifampin)
- Ritonavir
- Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and
moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole,
diltiazem, itraconazole)
- Endothelin receptor antagonists (ERAs) other than bosentan
10. Treatment with another investigational drug within 1 month prior to randomization or
planned treatment
",NULL,Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan;Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan;Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-03-08,2010-10-12,2010-10-12,64,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2011,2017-11-07,TRUE,FALSE,TRUE
10103,NCT01473602,NA,NCT01473602,NCT: 2011-11-14 ICTRP: 2011-11-14 DRKS: NA,1,1,NA,1,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 39 ICTRP: 39 DRKS: NA,NA,1,1,2,0,NA,"Triple (Participant, Care Provider, Investigator)",Double,worse,0,no indication,ganzer Artikel,10.1007/s11999-015-4669-z,NA,2011-11-17,NA,2012-01-31,2013-11-30,Interventional,Second Study of the Effect of Teriparatide on Hip Fracture Healing,Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing,Completed,Phase 3,39,Actual,Eli Lilly and Company,Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture,Percentage of Participants With Radiographic Evidence of Healing;Percentage of Participants With Pain Control During Ambulation;Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit;Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing;Percentage of Participants With Functional Evidence of Healing;Percentage of Participants Able to Ambulate;Percentage of Participants Who Regained Their Prefracture Ambulatory Status;Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain;Mean Change From Baseline to 6 Months in Gait Speed;Time to Revision Surgery;Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores;Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC);Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score,B3D-MC-GHDQ;14125,Second Study of the Effect of Teriparatide on Hip Fracture Healing,Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing,;;;,;;;,Interventional,,Phase 3,2011-11-14,2012-01-20,39,Completed,Eli Lilly and Company,NULL,"united states;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;united states;argentina;austria;brazil;canada;italy;united states;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;united states;argentina;austria;brazil;canada;italy;united states;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;united states;argentina;austria;brazil;canada;italy;united states;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;belgium;croatia;france;germany;greece;hungary;india;korea, republic of;netherlands;poland;romania;switzerland;turkey;united states;argentina;austria;brazil;canada;italy",Drug: Teriparatide;Drug: Placebo;Dietary Supplement: Calcium supplementation;Dietary Supplement: Vitamin D supplementation;Drug: Teriparatide;Drug: Placebo;Dietary Supplement: Calcium supplementation;Dietary Supplement: Vitamin D supplementation;Drug: Teriparatide;Drug: Placebo;Dietary Supplement: Calcium supplementation;Dietary Supplement: Vitamin D supplementation;Drug: Teriparatide;Drug: Placebo;Dietary Supplement: Calcium supplementation;Dietary Supplement: Vitamin D supplementation,"
Inclusion Criteria:
- Community dwelling men and postmenopausal women who were ambulatory before sustaining
a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
- Other than femoral neck fracture, be free of incapacitating conditions and have a life
expectancy of at least 2 years
- Have received or are eligible for treatment with internal fixation (sliding hip screw
or multiple cancellous screws) for the femoral neck fracture (the surgical procedure
itself is not performed as part of this study)
- Have given written informed consent (participant or proxy) after being informed of the
risks, medications, and study procedures
Exclusion Criteria:
- Increased baseline risk of osteosarcoma
- History of unresolved skeletal diseases affecting bone metabolism other than primary
osteoporosis
- Abnormally elevated serum calcium at screening
- Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
- Severe vitamin D deficiency at screening
- Active liver disease or jaundice
- Significantly impaired renal function
- Abnormal thyroid function not corrected by therapy
- History of malignant neoplasm in the 5 years prior to screening
- History of bone marrow or solid organ transplantation
- History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to
screening
- Previous treatment with the following bone active drugs is allowed but must be
discontinued at screening: oral bisphosphonates, selective estrogen receptor
modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable),
progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and
active vitamin D3 analogs. Androgen or other anabolic steroid use must be
discontinued, except for use of physiologic replacement testosterone
- Previous treatment with the following bone active drugs is exclusionary, if the stated
treatment durations have been met: strontium ranelate for any duration, intravenous
bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months
preceding screening
- Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation
in any other clinical trial studying PTH, teriparatide, or other PTH analogs
- Local or systemic treatment with bone morphogenic proteins or any other growth factor
- Previous fracture(s) or bone surgery in the currently fractured hip
- Soft-tissue infection at the operation site
- Treatment with bone grafting or osteotomies
- Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated
implants, or with noninvasive interventions
- Associated major injuries of a lower extremity including fractures of the foot, ankle,
tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the ankle, knee,
or hip
;
Inclusion Criteria:
- Community dwelling men and postmenopausal women who were ambulatory before sustaining
a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
- Other than femoral neck fracture, be free of incapacitating conditions and have a life
expectancy of at least 2 years
- Have received or are eligible for treatment with internal fixation (sliding hip screw
or multiple cancellous screws) for the femoral neck fracture (the surgical procedure
itself is not performed as part of this study)
- Have given written informed consent (participant or proxy) after being informed of the
risks, medications, and study procedures
Exclusion Criteria:
- Increased baseline risk of osteosarcoma
- History of unresolved skeletal diseases affecting bone metabolism other than primary
osteoporosis
- Abnormally elevated serum calcium at screening
- Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
- Severe vitamin D deficiency at screening
- Active liver disease or jaundice
- Significantly impaired renal function
- Abnormal thyroid function not corrected by therapy
- History of malignant neoplasm in the 5 years prior to screening
- History of bone marrow or solid organ transplantation
- History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to
screening
- Previous treatment with the following bone active drugs is allowed but must be
discontinued at screening: oral bisphosphonates, selective estrogen receptor
modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable),
progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and
active vitamin D3 analogs. Androgen or other anabolic steroid use must be
discontinued, except for use of physiologic replacement testosterone
- Previous treatment with the following bone active drugs is exclusionary, if the stated
treatment durations have been met: strontium ranelate for any duration, intravenous
bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months
preceding screening
- Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation
in any other clinical trial studying PTH, teriparatide, or other PTH analogs
- Local or systemic treatment with bone morphogenic proteins or any other growth factor
- Previous fracture(s) or bone surgery in the currently fractured hip
- Soft-tissue infection at the operation site
- Treatment with bone grafting or osteotomies
- Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated
implants, or with noninvasive interventions
- Associated major injuries of a lower extremity including fractures of the foot, ankle,
tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the ankle, knee,
or hip
;
Inclusion Criteria:
- Community dwelling men and postmenopausal women who were ambulatory before sustaining
a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
- Other than femoral neck fracture, be free of incapacitating conditions and have a life
expectancy of at least 2 years
- Have received or are eligible for treatment with internal fixation (sliding hip screw
or multiple cancellous screws) for the femoral neck fracture (the surgical procedure
itself is not performed as part of this study)
- Have given written informed consent (participant or proxy) after being informed of the
risks, medications, and study procedures
Exclusion Criteria:
- Increased baseline risk of osteosarcoma
- History of unresolved skeletal diseases affecting bone metabolism other than primary
osteoporosis
- Abnormally elevated serum calcium at screening
- Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
- Severe vitamin D deficiency at screening
- Active liver disease or jaundice
- Significantly impaired renal function
- Abnormal thyroid function not corrected by therapy
- History of malignant neoplasm in the 5 years prior to screening
- History of bone marrow or solid organ transplantation
- History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to
screening
- Previous treatment with the following bone active drugs is allowed but must be
discontinued at screening: oral bisphosphonates, selective estrogen receptor
modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable),
progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and
active vitamin D3 analogs. Androgen or other anabolic steroid use must be
discontinued, except for use of physiologic replacement testosterone
- Previous treatment with the following bone active drugs is exclusionary, if the stated
treatment durations have been met: strontium ranelate for any duration, intravenous
bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months
preceding screening
- Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation
in any other clinical trial studying PTH, teriparatide, or other PTH analogs
- Local or systemic treatment with bone morphogenic proteins or any other growth factor
- Previous fracture(s) or bone surgery in the currently fractured hip
- Soft-tissue infection at the operation site
- Treatment with bone grafting or osteotomies
- Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated
implants, or with noninvasive interventions
- Associated major injuries of a lower extremity including fractures of the foot, ankle,
tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the ankle, knee,
or hip
;
Inclusion Criteria:
- Community dwelling men and postmenopausal women who were ambulatory before sustaining
a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
- Other than femoral neck fracture, be free of incapacitating conditions and have a life
expectancy of at least 2 years
- Have received or are eligible for treatment with internal fixation (sliding hip screw
or multiple cancellous screws) for the femoral neck fracture (the surgical procedure
itself is not performed as part of this study)
- Have given written informed consent (participant or proxy) after being informed of the
risks, medications, and study procedures
Exclusion Criteria:
- Increased baseline risk of osteosarcoma
- History of unresolved skeletal diseases affecting bone metabolism other than primary
osteoporosis
- Abnormally elevated serum calcium at screening
- Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
- Severe vitamin D deficiency at screening
- Active liver disease or jaundice
- Significantly impaired renal function
- Abnormal thyroid function not corrected by therapy
- History of malignant neoplasm in the 5 years prior to screening
- History of bone marrow or solid organ transplantation
- History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to
screening
- Previous treatment with the following bone active drugs is allowed but must be
discontinued at screening: oral bisphosphonates, selective estrogen receptor
modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable),
progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and
active vitamin D3 analogs. Androgen or other anabolic steroid use must be
discontinued, except for use of physiologic replacement testosterone
- Previous treatment with the following bone active drugs is exclusionary, if the stated
treatment durations have been met: strontium ranelate for any duration, intravenous
bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months
preceding screening
- Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation
in any other clinical trial studying PTH, teriparatide, or other PTH analogs
- Local or systemic treatment with bone morphogenic proteins or any other growth factor
- Previous fracture(s) or bone surgery in the currently fractured hip
- Soft-tissue infection at the operation site
- Treatment with bone grafting or osteotomies
- Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated
implants, or with noninvasive interventions
- Associated major injuries of a lower extremity including fractures of the foot, ankle,
tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the ankle, knee,
or hip
",NULL,Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture;Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture,Percentage of Participants With Radiographic Evidence of Healing;Percentage of Participants With Pain Control During Ambulation;Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit;Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing;Percentage of Participants With Functional Evidence of Healing;Percentage of Participants Able to Ambulate;Percentage of Participants Who Regained Their Prefracture Ambulatory Status;Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain;Mean Change From Baseline to 6 Months in Gait Speed;Time to Revision Surgery;Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores;Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC);Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score,NCT01473602; 14125; B3D-MC-GHDQ,2012-09-28,no,Femur Neck Fracture; Fracture of neck of femur,Arm 1 Drug: Teriparatide; Arm 2 Drug: Placebo; Arm 3 Dietary Supplement: Calcium supplementation; Arm 4 Dietary Supplement: Vitamin D supplementation,Interventional,Randomized controlled trial,Blinded,Placebo,Parallel,III,"- Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture; time frame: 12 months; Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.
","- Percentage of Participants With Radiographic Evidence of Healing; time frame: Randomization up to 12 months; The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.
Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100.
- Percentage of Participants With Pain Control During Ambulation; time frame: Up to 12 months; The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100.
- Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit; time frame: Up to 12 months; The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100.
- Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing; time frame: Up to 12 months; The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.
- Percentage of Participants With Functional Evidence of Healing; time frame: Up to 12 Months; Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.
Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100.
- Percentage of Participants Able to Ambulate; time frame: Up to 12 months; Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100.
- Percentage of Participants Who Regained Their Prefracture Ambulatory Status; time frame: Up to 12 months; Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100.
- Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain; time frame: Baseline, 6 Months; The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type.
- Mean Change From Baseline to 6 Months in Gait Speed; time frame: Baseline, 6 Months; The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type
- Time to Revision Surgery; time frame: Baseline to Revision Surgery (up to 14.14 Months); Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.
- Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores; time frame: Baseline, 6 Months; SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
- Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC); time frame: Baseline, up to 6 Months; WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
- Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score; time frame: Baseline, 6 Months; The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.
","United States; Belgium; Canada; Croatia; France; Germany; Greece; Hungary; India; Korea, Republic of; Netherlands; Poland; Romania; Switzerland; Turkey",[---]* Berlin; [---]* Dresden; [---]* Freiburg; [---]* Göttingen; [---]* Hamburg; [---]* Köln; [---]* Leipzig; [---]* Marburg; [---]* Regensburg,2012-01-31,NA,1220,2013-11-01,"- Community dwelling men and postmenopausal women who were ambulatory before sustaining
a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
- Other than femoral neck fracture, be free of incapacitating conditions and have a
life expectancy of at least 2 years
- Have received or are eligible for treatment with internal fixation (sliding hip screw
or multiple cancellous screws) for the femoral neck fracture (the surgical procedure
itself is not performed as part of this study)
- Have given written informed consent (participant or proxy) after being informed of
the risks, medications, and study procedures
","- Increased baseline risk of osteosarcoma
- History of unresolved skeletal diseases affecting bone metabolism other than primary
osteoporosis
- Abnormally elevated serum calcium at screening
- Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
- Severe vitamin D deficiency at screening
- Active liver disease or jaundice
- Significantly impaired renal function
- Abnormal thyroid function not corrected by therapy
- History of malignant neoplasm in the 5 years prior to screening
- History of bone marrow or solid organ transplantation
- History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to
screening
- Previous treatment with the following bone active drugs is allowed but must be
discontinued at screening: oral bisphosphonates, selective estrogen receptor
modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable),
progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and
active vitamin D3 analogs. Androgen or other anabolic steroid use must be
discontinued, except for use of physiologic replacement testosterone
- Previous treatment with the following bone active drugs is exclusionary, if the
stated treatment durations have been met: strontium ranelate for any duration,
intravenous bisphosphonates in the 12 months preceding screening, and/or denosumab in
the 6 months preceding screening
- Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation
in any other clinical trial studying PTH, teriparatide, or other PTH analogs
- Local or systemic treatment with bone morphogenic proteins or any other growth factor
- Previous fracture(s) or bone surgery in the currently fractured hip
- Soft-tissue infection at the operation site
- Treatment with bone grafting or osteotomies
- Treatment with augmentation using any type of degradable cement,
hydroxyapatite-coated implants, or with noninvasive interventions
- Associated major injuries of a lower extremity including fractures of the foot,
ankle, tibia, fibula, knee, femur, femoral head, or pelvis; dislocations of the
ankle, knee, or hip
",Second Study of the Effect of Teriparatide on Femoral Neck Fracture Healing,"Recruiting complete, follow-up complete",Eli Lilly and Company; Eli Lilly and Company; Eli Lilly and Company,[---]*; [---]*; [---]*,Arm 1 Drug: Teriparatide; Arm 2 Drug: Placebo; Arm 3 Dietary Supplement: Calcium supplementation; Arm 4 Dietary Supplement: Vitamin D supplementation,2012-01-31,2011-11-14,2011-11-14,39,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2012,2015-04-10,TRUE,TRUE,TRUE
17417,NCT00274963,NA,NCT00274963,NCT: 2006-01-10 ICTRP: 2006-01-10 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,3,NA,"no time frame, no measure",3,NA,"no time frame, no measure",NCT: Anticipated 60 ICTRP: 60 DRKS: NA,NA,1,0,NA,NA,no info,NA,NA,NA,0,no indication,Review,https://doi.org/10.1053/j.seminhematol.2011.03.004,NA,2006-01-11,NA,2004-10-31,2009-10-31,Interventional,Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia,Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM),Completed,Phase 2,60,Anticipated,German CLL Study Group,Overall remission rate (partial and complete remission),Time to progression;Safety and tolerability;Overall survival,EU-20551;RIBOSEPHARM-GCLLSK-CLL2K;CLL2K,Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia,Treatment of Relapsed / Refractory Chronic Lymphocytic Leukemia (CLL) WITH Bendamustine / Mitoxantrone (BM),,,Interventional,Allocation: Non-Randomized. Primary purpose: Treatment. ,Phase 2,2006-01-10,2004-10-20,60,Completed,German CLL Study Group,NULL,germany,Drug: bendamustine hydrochloride;Drug: mitoxantrone hydrochloride,
DISEASE CHARACTERISTICS:
- Cytologically and immunophenotypically confirmed diagnosis of B-cell chronic
lymphocytic leukemia (CLL)
- Relapsed or refractory disease
PATIENT CHARACTERISTICS:
- No known hypersensitivity to any of the study medications
- No uncontrolled infection
- No impaired organ function
PRIOR CONCURRENT THERAPY:
- Not specified
,NULL,Overall remission rate (partial and complete remission),Time to progression;Safety and tolerability;Overall survival,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-10-31,2006-01-10,2006-01-10,60,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2004,2018-05-09,TRUE,FALSE,FALSE
11660,NCT01231347,NA,NCT01231347,NCT: 2010-10-14 ICTRP: 2010-10-14 DRKS: NA,1,1,NA,1,1,NA,NA,2,1,NA,5,1,NA,4,1,no measure,NCT: Actual 800 ICTRP: 800 DRKS: NA,800,1,1,2,0,NA,"Triple (Participant, Care Provider, Investigator)",Double,worse,1,NA,ganzer Artikel,https://doi.org/10.1093/annonc/mdv027,NA,2010-11-01,NA,2011-04-30,2012-12-31,Interventional,QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas",Terminated,Phase 3,800,Actual,"NantCell, Inc.",To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas,Progression free survival;Objective response rate;Time to disease progression;Disease control rate;Number of subjects with adverse events,20060540;GAMMA;QUILT-2.014;20060540,QUILT-2.014: Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas,"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination With Gemcitabine as First Line Therapy for Metastatic Adenocarcinoma of the Pancreas",,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment",Phase 3,2010-10-14,2011-04-20,800,Terminated,"NantCell, Inc.",Takeda,"united states;australia;austria;belgium;brazil;bulgaria;canada;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;japan;korea, republic of;lithuania;netherlands;poland;portugal;romania;russian federation;serbia;slovakia;slovenia;spain;sweden;switzerland;taiwan;united kingdom;australia;austria;belgium;brazil;bulgaria;canada;czech republic;denmark;finland;france;germany;greece;hong kong;hungary;italy;japan;korea, republic of;lithuania;netherlands;poland;portugal;romania;russian federation;serbia;slovakia;slovenia;spain;sweden;switzerland;taiwan;united kingdom;united states",Drug: AMG 479;Drug: Placebo;Drug: AMG 479;Drug: gemcitabine,"
Inclusion Criteria:
- Untreated metastatic adenocarcinoma of the pancreas
- Adequate hematologic, renal and liver function
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria:
- Prior chemotherapy or radiotherapy for pancreatic cancer
- Central nervous system metastases
- External biliary drain
",NULL,To determine if AMG 479 in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic adenocarcinoma of the pancreas,Progression free survival;Objective response rate;Time to disease progression;Disease control rate;Number of subjects with adverse events,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-04-30,2010-10-14,2010-10-14,800,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2011,2016-10-26,TRUE,FALSE,TRUE
9103,NCT01645150,NA,NCT01645150,NCT: 2012-06-11 ICTRP: 2012-06-11 DRKS: NA,1,1,NA,1,1,NA,NA,1,1,NA,4,0,no AM; Identified as secondary endpoint in paper,4,1,no AM,NCT: Actual 20 ICTRP: 20 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1007/s00520-017-3788-3,NA,2012-07-20,NA,2012-05-31,2015-12-31,Interventional,Reduction of Cancer Related Fatigue in Patients During TKI Therapy,Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy,Completed,N/A,20,Actual,German Cancer Research Center,Change in cancer related fatigue,"Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.;Change in endurance capacity;Change in body composition;Change in quality of life;Change in depression;Time of the first tumor progression under TKI therapy;Time of reduction or replacement of TKI therapy",S-154/2012,Reduction of Cancer Related Fatigue in Patients During TKI Therapy,Pilot Study on the Effects of Strength Training on Cancer Related Fatigue in Cancer Patients During Tyrosine Kinase Inhibitor Therapy,;;;;,;;;;,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",N/A,2012-06-11,2012-05-20,20,Completed,German Cancer Research Center,NULL,germany,Behavioral: Progressive strength training,"
Inclusion Criteria:
- Male and female cancer patients
- Prior to tyrosine kinase inhibitor therapy (any substance, any line)
- Age: at least 18 yrs
- Body mass index (BMI): at least 18 kg/m2
- ECOG performance status: at most 2
- Must be able to meet the requirements of the study protocol
Exclusion Criteria:
- Acute infectious diseases
- No ambulatory ability
- Severe neurological disorders
- Severe cardiovascular diseases
- Severe pulmonary insufficiency
- Severe renal insufficiency
- Other current tumor diseases
- Conditions rendering compliance impossible
- Participation in regular strength training
",NULL,Change in cancer related fatigue,"Change in muscle strength of the knee extensor, hip flexor and forearm flexor muscles.;Change in endurance capacity;Change in body composition;Change in quality of life;Change in depression;Time of the first tumor progression under TKI therapy;Time of reduction or replacement of TKI therapy",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-05-31,2012-06-11,2012-06-11,20,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2012,2016-03-21,TRUE,FALSE,FALSE
19043,NCT03429543,NA,NCT03429543,NCT: 2018-02-06 ICTRP: 2018-02-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no AM,5,NA,NA,NCT: Anticipated 138 ICTRP: 138 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-02-12,NA,2018-03-20,2022-01-31,Interventional,Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM,"A Double-blind, Randomised, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Empagliflozin and Linagliptin Over 26 Weeks, With a Double-blind Active Treatment Safety Extension Period up to 52 Weeks, in Children and Adolescents With Type 2 Diabetes Mellitus",Recruiting,Phase 3,186,Anticipated,Boehringer Ingelheim,DINAMO TM: Change from baseline in HbA1c (%);DINAMO TM Mono: occurrence of treatment failure up to or at Week 26,DINAMO TM: Change from baseline in fasting plasma glucose (mg/dl);DINAMO TM: Change from baseline in body weight (kg);DINAMO TM: Change from baseline in systolic blood pressure (SBP);DINAMO TM: Change from baseline in diastolic blood pressure (DBP);DINAMO TM: Proportion of patients who achieve HbA1c < 6.5%;DINAMO TM: Proportion of patients who achieve HbA1c < 7.0%;DINAMO TM Mono: Time to treatment failure;DINAMO TM Mono: Change in HbA1c (%) from baseline;DINAMO TM Mono: Change in FPG (mg/dL) from baseline;DINAMO TM Mono: Change in body weight (kg) from baseline;DINAMO TM Mono: Change in SBP (mmHg) from baseline;DINAMO TM Mono: Change in DBP (mmHg) from baseline;DINAMO TM Mono: Proportion of patients who achieve HbA1c < 6.5%;DINAMO TM Mono :Proportion of patients who achieve HbA1c < 7.0%,2016-000669-21;1218-0091,Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM,"A Double-blind, Randomised, Placebo-controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Empagliflozin and Linagliptin Over 26 Weeks, With a Double-blind Active Treatment Safety Extension Period up to 52 Weeks, in Children and Adolescents With Type 2 Diabetes Mellitus",clintriage.rdg@boehringer-ingelheim.com,clintriage.rdg@boehringer-ingelheim.com,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2018-02-06,2018-03-20,186,Recruiting,Boehringer Ingelheim,NULL,"united states;argentina;brazil;canada;china;colombia;germany;israel;korea, republic of;mexico;netherlands;portugal;puerto rico;russian federation;thailand;united kingdom;argentina;brazil;canada;china;colombia;germany;israel;korea, republic of;mexico;netherlands;portugal;puerto rico;russian federation;thailand;united kingdom;united states",Drug: Linagliptin;Drug: Empagliflozin;Drug: Placebo,"
Inclusion Criteria:
- Patients aged 10 to 17 years (inclusive) at the time of randomisation (Visit 2)
- Male and female patients
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective
methods of birth control per ICH M3 (R2) that result in a low failure rate of less
than 1% per year when used consistently and correctly. A list of contraception methods
meeting these criteria is provided in the patient's legal representative information
sheet.
- Signed and dated written informed consent provided by the patient's parent(s) (or
legal guardian) and patient's assent in accordance with ICH-GCP and local legislation
prior to admission to the trial (informed assent will be sought according to the
patient's age, level of maturity, competence and capacity)
- Documented diagnosis of T2DM for at least 12 weeks at Visit 1A
- Insufficient glycaemic control as measured by the central laboratory at Visit 1A:
- DINAMO TM: HbA1c = 6.5% and = 10.5%
- DINAMO TM Mono: HbA1c = 6.5% and = 9.0%
- DINAMO TM: Patients treated with
- diet and exercise plus metformin at a stable dose for 8 weeks prior to Visit 2
AND/OR
- diet and exercise plus stable basal or MDI insulin therapy,, defined as a weekly
average variation of the basal insulin dose = 0.1 IU/kg over 8 weeks prior to
Visit 2. Patients treated with diet and exercise only and not tolerating
metformin (defined as patients who were on metformin treatment for at least 1
week and had to discontinue metformin due to metformin-related side effects as
assessed by the investigator) are also eligible in this trial.
- DINAMOTM Mono: Drug-naïve patients or patients not on active treatment (including a
metformin washout for at least 12 weeks prior to Visit 2)
- BMI = 85th percentile for age and sex according to WHO references at Visit 1B
- Non-fasting serum C-peptide levels = 0.6 ng/ml as measured by the central laboratory
at Visit 1A
- Compliance with trial medication intake must be between 75% and 125% during the
open-label placebo run-in period
- Further inclusion criteria apply
Exclusion Criteria:
- Any history of acute metabolic decompensation such as diabetic ketoacidosis within 8
weeks prior to Visit 1A and up to randomisation (mild to moderate polyuria at the time
of randomisation is acceptable)
- Diagnosis of monogenic diabetes (e.g. MODY)
- History of pancreatitis
- Diagnosis of metabolic bone disease
- Gastrointestinal disorders that might interfere with study drug absorption according
to investigator assessment
- Secondary obesity as part of a syndrome (e.g. Prader-Willi syndrome)
- Any antidiabetic medication (with the exception of metformin and/or insulin background
therapy) within 8 weeks prior to Visit 1A and until Visit 2
- Treatment with weight reduction medications (including anti-obesity drugs) within 3
months prior to Visit 1A and until Visit 2
- History of weight-loss surgery or current aggressive diet regimen (according to
investigator assessment) at Visit 1A and until Visit 2
- Treatment with systemic corticosteroids for > 1 week within 4 weeks prior to Visit 1A
and up to Visit 2 Inhaled or topical use of corticosteroids (e.g. for asthma/chronic
obstructive pulmonary disease) is acceptable.
- Change in dose of thyroid hormones within 6 weeks prior to Visit 1A or planned change
or initiation of such therapy before Visit 2
- Known hypersensitivity or allergy to the investigational products or their excipients
- Impaired renal function defined as estimated Glomerular Filtration Rate (eGFR) < 60
ml/min/1.73m² (according to Zappitelli formula) as measured by the central laboratory
at Visit 1A
- Indication of liver disease defined by serum level of either alanine transaminase
(ALT), aspartate transaminase (AST) or alkaline phosphatase above 3 fold upper limit
of normal (ULN) at Visit 1A as measured by the central laboratory at Visit 1A
- History of belonephobia (needle phobia)
- Any documented active or suspected malignancy or history of malignancy within 5 years
prior to Visit 1A, except appropriately treated basal cell carcinoma of the skin or in
situ carcinoma of uterine cervix
- Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g.
malaria, babesiosis, haemolytic anaemia)
- Any other acute or chronic medical or psychiatric condition or laboratory abnormality
that, based on investigator's judgement, would jeopardize patient safety during trial
participation or would affect the study outcome
- Medical contraindications to metformin according to the local label (for patient on
metformin background therapy)
- Patient not able or cannot be supported by his/her parent(s) or legal guardian to
understand and comply with study requirements based on investigator's judgement
- Previous randomisation in this trial
- Currently enrolled in another investigational device or drug trial, or less than 30
days since ending another investigational device or drug trial(s), or receiving other
investigational treatment(s)
- Chronic alcohol or drug abuse within 3 months prior to Visit 1A or any condition that,
in the investigator's opinion, makes them an unreliable trial patient or unlikely to
complete the trial
- Female patients who are pregnant, nursing, or who plan to become pregnant in the trial
",NULL,DINAMO TM: Change from baseline in HbA1c (%);DINAMO TM Mono: occurrence of treatment failure up to or at Week 26,DINAMO TM: Change from baseline in fasting plasma glucose (mg/dl);DINAMO TM: Change from baseline in body weight (kg);DINAMO TM: Change from baseline in systolic blood pressure (SBP);DINAMO TM: Change from baseline in diastolic blood pressure (DBP);DINAMO TM: Proportion of patients who achieve HbA1c < 6.5%;DINAMO TM: Proportion of patients who achieve HbA1c < 7.0%;DINAMO TM Mono: Time to treatment failure;DINAMO TM Mono: Change in HbA1c (%) from baseline;DINAMO TM Mono: Change in FPG (mg/dL) from baseline;DINAMO TM Mono: Change in body weight (kg) from baseline;DINAMO TM Mono: Change in SBP (mmHg) from baseline;DINAMO TM Mono: Change in DBP (mmHg) from baseline;DINAMO TM Mono: Proportion of patients who achieve HbA1c < 6.5%;DINAMO TM Mono :Proportion of patients who achieve HbA1c < 7.0%,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-03-20,2018-02-06,2018-02-06,186,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-12-15,TRUE,FALSE,FALSE
13001,NCT01012921,NA,NCT01012921,NCT: 2009-11-11 ICTRP: 2009-11-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,2,NA,"no AM, no measure, no type of outcome",NA,NA,NA,NCT: Actual 117 ICTRP: 117 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Review,https://www.dtscience.com/wp-content/uploads/2020/01/Trends-in-clinical-trials-on-bone-regeneration-in-dentistry—towards-an-innovative-development-in-dental-implant-treatment.pdf,NA,2009-11-13,NA,2009-09-30,2015-12-31,Interventional,Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants,Straumann® MembraGel Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants,Completed,N/A,117,Actual,Institut Straumann AG,The Bone Fill Was Assessed at 6 Months After Regenerative Therapy.,,CR 07/07,Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants,Straumann® MembraGel Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants,,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",N/A,2009-11-11,2009-09-20,117,Completed,Institut Straumann AG,NULL,belgium;germany;hungary;italy;spain;sweden;switzerland;belgium;germany;hungary;italy;spain;sweden;switzerland,Device: barrier membrane;Device: MembraGel;Other: Bio-Gide® membrane,"
Inclusion Criteria:
- Subjects must have voluntarily signed the informed consent form before any study
related action
- Males and females must be at least 18 years of age and not more than 80 year old.
- Have at least one missing tooth in the posterior mandible or maxilla in quadrant 1,
2, 3, 4 (FDI positions 4-7), requiring one or more dental implants.
- Partially edentulous patients and patients in need of a fixed dental prosthesis
- The tooth at the implant site(s) must have been extracted or lost at least 6 weeks
before the date of implantation.
- Bone defect(s) must be present with a vertical dimension greater than or equal to 3
mm at the foreseen GBR site measured after dental implant placement.
- Full mouth bleeding on Probing (FMBoP) and full mouth plaque score (FMPI) are both
lower or equal than 25%
- Patients must be committed to the study.
Exclusion Criteria:
- Presence of conditions requiring chronic routine prophylactic use of antibiotics
(e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular
anomalies, prosthetic joint replacements)
- Major systemic diseases
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonate intravenously
- Current pregnancy or breastfeeding women
- Physical or mental handicaps that would interfere with the ability to perform
adequate oral hygiene
- Alcoholism or chronically drug abuse
- Immunocompromised patients
- Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew
tobacco
- Conditions or circumstances, in the opinion of the investigator, which would prevent
completion of study participation or interfere with analysis of study results, such
as history of non-compliance, or unreliability.
Local exclusion criteria
- Local inflammation, including untreated periodontitis
- Regenerative treatment necessary adjacent to the planned study site of interest
- Mucosal diseases or oral lesions
- History of local irradiation therapy
- Severe bruxing or clenching habits
- Persistent intraoral infection
- Patients with inadequate oral hygiene or unmotivated for adequate home care
- Previous GBR or GTR treatment at the implant site
- Lack of primary stability of the dental implant at site of interest. In this instance
the patient must be withdrawn and the patient treated accordingly (exclusion criteria
at surgery)
",NULL,non-inferiority of Straumann® MembraGel compared to a standard collagen membrane (Bio-Gide®)used for GBR in defects around Straumann implants. The bone fill will be assessed at baseline compared to 6 months after regenerative therapy.,• Change of crestal bone level;• Soft tissue parameters,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-09-30,2009-11-11,2009-11-11,117,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2009,2017-05-29,TRUE,FALSE,FALSE
15026,NCT00665730,NA,NCT00665730,NCT: 2008-04-23 ICTRP: 2008-04-23 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,4,NA,no measure (how are adhesions assessed?),4,NA,no measure (how are adhesions assessed?),NCT: Actual 5 ICTRP: 5 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no indication (type of surgery),kein Artikel,NA,NA,2008-04-24,NA,2007-07-31,2008-06-30,Interventional,Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions,Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery),Terminated,N/A,5,Actual,Sanofi,Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision,"Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.;Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.",SSPRAY00406,Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions,Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery),,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention",N/A,2008-04-23,2007-07-20,5,Terminated,"Genzyme, a Sanofi Company",NULL,czech republic;denmark;france;germany;united kingdom;czech republic;denmark;france;germany;united kingdom,Device: Sepraspray,
Inclusion Criteria:
- Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with
diverting ileostomy.
Exclusion Criteria:
- Patients who are pregnant.
- Patients with ongoing abdominal abscess.
- Patients with ongoing bacterial peritonitis.
,NULL,Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision,"Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.;Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-07-31,2008-04-23,2008-04-23,5,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2007,2015-05-07,TRUE,FALSE,FALSE
16831,NCT00372177,NA,NCT00372177,NCT: 2006-09-05 ICTRP: 2006-09-05 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,1,NA,Only type of outcome mentioned,0,NA,"unclear to this assessor what is meant by ""equal results"" and what variables are of interest here",NCT: Actual 5 ICTRP: 5 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-09-06,NA,2007-07-31,2008-05-31,Interventional,The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis,The Use of Anti-CD4 mAb-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis (an Open Proof of Concept Study),Completed,Phase 1/Phase 2,5,Actual,Biotectid GmbH,safety and tolerability of this diagnostic agent,endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results,EP 1645;Biotectid POC EP 1645,The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis,The Use of Anti-CD4 mAb-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis (an Open Proof of Concept Study),,,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic",Phase 1/Phase 2,2006-09-05,2007-07-20,5,Completed,Biotectid GmbH,Technische Universität Dresden;University of Leipzig,germany,Radiation: Fab-fragment of Anti-human CD4,"
Inclusion Criteria:
- Male and female subjects above 50 years of age
- Suffering from joint pain which is due to active rheumatoid arthritis
- Obvious signs of inflammation in at least one joint (e.g. swelling, erythema, or
local elevated temperature)
- Otherwise healthy
- Informed consent
Exclusion Criteria:
- Patients 80 years and older
- Clinically significant disease of the cardiovascular system, respiratory system,
hepato-biliary system or central nervous system (CNS)
- Excretory hepatic or renal insufficiency
- Regular intake of any drug, except for hormone replacement therapy in females
- Previous administration of xenogenous proteins
- History of anaphylactic reaction to any drug administered by a parenteral pathway
- Previous participation in a radiopharmaceutical drug trial (unless the effective dose
acquired by participation in the current trial will remain below 10 mSv)
- Participation in any clinical drug trial within 3 months prior to enrolment
- Women of child-bearing potential (child-bearing potential to be ruled out by one of
the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy,
or bilateral tubal ligation)
- Long term medication with strong antiphlogistic agents/pain killers such as
methotrexate, corticoids, or immunosuppressants prior to enrolment
",NULL,safety and tolerability of this diagnostic agent,endpoint for the proof of concept will be the number of patients needed to obtain a series of equal results,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-07-31,2006-09-05,2006-09-05,5,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,NA,TRUE,2007,2008-05-26,TRUE,FALSE,FALSE
18870,NCT00044915,NA,NCT00044915,NCT: 2002-09-06 ICTRP: 2002-09-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,0,NA,no info,NA,NA,NA,NCT: Actual 782 ICTRP: 782 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2002-09-09,NA,2000-12-31,2004-09-30,Interventional,Repinotan in Patients With Acute Ischemic Stroke,"A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke",Completed,Phase 2,782,Actual,Bayer,NA,NA,100282,Repinotan in Patients With Acute Ischemic Stroke,"A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",Phase 2,2002-09-06,2000-12-20,782,Completed,Bayer,NULL,united states;australia;austria;belgium;canada;finland;france;germany;hungary;israel;italy;netherlands;spain;sweden;united kingdom;united states;australia;austria;belgium;canada;finland;france;germany;hungary;israel;italy;netherlands;spain;sweden;united kingdom,Drug: Repinotan HCl (BAYX3702);Drug: Placebo,"
Inclusion Criteria:
- Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum),
of suspected thromboembolic origin.
- Males or females aged 18 years or over.
- National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor
deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least
one of the following: Visual field deficit, neglect, or aphasia. If a patient
receives t-PA, NIH-SS must be performed prior to receiving the study drug but after
infusion of t-PA is initiated.
- Signed informed consent from patient or legally authorized representative
Exclusion Criteria:
- CT scan evidence of:
- Clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA
territory or evidence of significant mass effect with shift of midline or major areas
of sulcal effacement associated with loss of cortical definition (grey-white
distinction). Minor early CT changes are common in MCA strokes and patients with
early or subtle changes are eligible.
- A primary intra-cerebral haemorrhage or any finding not consistent with an acute
ischemic stroke as the cause of presenting symptoms.
- Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure
sensory deficit, ataxia/clumsy hand syndromes)
- Neurological (other than the presenting stroke) or psychiatric conditions that may
affect the patient's functional status and/or that may interfere with the patient's
assessment
- Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2
regardless of cause)
- Generalized seizures having developed since the onset of stroke symptoms
- Systolic blood pressure > 210 or < 110 mmHg (confirmed by up to three readings prior
to randomization)
- Diastolic blood pressure > 110 or < 60 mmHg (confirmed by up to three readings prior
to randomization)
- Myocardial infarction within 3 months, unstable angina within 3-5 days prior to
starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe
conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch
Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure
- History of myocarditis, cardiomyopathy or aortic stenosis
- Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of
QTc prolongation or QTc interval > 450 msec males and 470 msec females on baseline
ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine,
procainamide, amiodarone, sotalol)
- Any patients that require initiation of new digoxin therapy are excluded. Patients
already on digoxin therapy (for at least 1 month stable dose) at time of enrollment
will be allowed in the study.
- Electrolyte imbalance at baseline. Should the results not be available before
starting the study drug infusion, the patients will be allowed in the study providing
that the corrective therapy of any abnormal electrolyte results is implemented
immediately upon availability of the laboratory report.
- Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting,
anorexia nervosa, bulimia nervosa) will also be excluded at baseline.
- Participation in a research protocol for investigation of a pharmaceutical agent or
innovative invasive procedure (including intra-arterial t-PA) within the past 30 days
- Previously in the BRAIN-Study or treated with repinotan
- Life expectancy of less than 6 months due to comorbid conditions
- Any other known clinically significant medical disorder (e.g., cardiovascular,
gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic
disturbances, respiratory, immunological, hematological or bleeding disorder, cancer,
AIDS)
",NULL,NULL,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-12-31,2002-09-06,2002-09-06,782,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2000,2009-06-09,TRUE,FALSE,FALSE
8951,NCT01675427,NA,NCT01675427,NCT: 2012-08-24 ICTRP: 2012-08-24 DRKS: NA,0,1,"Does not seem to be interventional, will not rate Int-Q",1,1,NA,NA,NA,NA,NA,5,1,NA,5,1,NA,NCT: Actual 4766 ICTRP: 4766 DRKS: NA,3003,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1186/s40064-016-3663-6,NA,2012-08-30,NA,2011-08-31,2013-10-31,Interventional,A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C,"An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C",Completed,Phase 4,4766,Actual,Hoffmann-La Roche,Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced,"Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced;Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive;Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced;Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive;Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced;Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive;BMI by IL28B Genotype rs12979860: Treatment-Experienced;BMI by IL28B Genotype rs8099917: Treatment-Naive;BMI by IL28B Genotype rs8099917: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced;Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced;Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive;Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced;Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype;Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype;Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype;Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype;Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype;Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype",MV25600,A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C,"An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C",;;;,;;;,Interventional,,Phase 4,2012-08-24,2011-08-20,4766,Completed,Hoffmann-La Roche,NULL,"united states;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;venezuela;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;united states;venezuela;united states;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;venezuela;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;united states;venezuela;united states;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;venezuela;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;united states;venezuela;united states;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;venezuela;argentina;belgium;chile;egypt;estonia;france;germany;greece;italy;kuwait;latvia;lebanon;lithuania;macedonia, the former yugoslav republic of;mexico;oman;pakistan;peru;portugal;qatar;romania;serbia;slovakia;sweden;switzerland;syrian arab republic;taiwan;turkey;united arab emirates;united states;venezuela",Other: Interleukin 28B testing;Other: Interleukin 28B testing;Other: Interleukin 28B testing;Other: Interleukin 28B testing,
Inclusion Criteria:
- Adult (according to local legislation) male or female patient
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who received prior interferon-based
therapy for CHC for whom data on treatment received and treatment outcome is
available; information on fibrosis stage prior to previous treatment is also required
Exclusion Criteria:
- Co-infection with hepatitis B
- History or evidence of decompensated liver disease
- History of major organ transplantation with an existing functional graft (including
liver transplantation)
- End stage renal disease
;
Inclusion Criteria:
- Adult (according to local legislation) male or female patient
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who received prior interferon-based
therapy for CHC for whom data on treatment received and treatment outcome is
available; information on fibrosis stage prior to previous treatment is also required
Exclusion Criteria:
- Co-infection with hepatitis B
- History or evidence of decompensated liver disease
- History of major organ transplantation with an existing functional graft (including
liver transplantation)
- End stage renal disease
;
Inclusion Criteria:
- Adult (according to local legislation) male or female patient
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who received prior interferon-based
therapy for CHC for whom data on treatment received and treatment outcome is
available; information on fibrosis stage prior to previous treatment is also required
Exclusion Criteria:
- Co-infection with hepatitis B
- History or evidence of decompensated liver disease
- History of major organ transplantation with an existing functional graft (including
liver transplantation)
- End stage renal disease
;
Inclusion Criteria:
- Adult (according to local legislation) male or female patient
- Chronic hepatitis C (CHC)
- Patients naïve to CHC treatment or patients who received prior interferon-based
therapy for CHC for whom data on treatment received and treatment outcome is
available; information on fibrosis stage prior to previous treatment is also required
Exclusion Criteria:
- Co-infection with hepatitis B
- History or evidence of decompensated liver disease
- History of major organ transplantation with an existing functional graft (including
liver transplantation)
- End stage renal disease
,NULL,Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced;Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced,"Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced;Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive;Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced;Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive;Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced;Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive;BMI by IL28B Genotype rs12979860: Treatment-Experienced;BMI by IL28B Genotype rs8099917: Treatment-Naive;BMI by IL28B Genotype rs8099917: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced;Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive;Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced;Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive;Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive;Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced;Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive;Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced;Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive;Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced;Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3]);Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total]);Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype;Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype;Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype;Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype;Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype;Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype;Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-08-31,2012-08-24,2012-08-24,4766,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2011,2015-08-12,TRUE,FALSE,FALSE
8287,NCT01798485,DRKS00006317,DRKS00006317,NCT: 2013-02-04 ICTRP: 2014-12-15 DRKS: 2014-12-15,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 696 ICTRP: 850 DRKS: [---]* 850,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,Abstract,10.1200/jco.2014.32.15_suppl.tps8118,NA,2013-02-25,NA,2013-04-30,2015-12-31,Interventional,A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC,"A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma",Terminated,Phase 3,696,Actual,Synta Pharmaceuticals Corp.,Overall Survival as of 19 October 2015,Progression-free Survival (PFS) as of 19 October 2015;Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Objective Response Rate (ORR) as of 19 October 2015;Disease Control Rate (DCR) as of 19 October 2015;Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015;Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015;Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015;Participants With Treatment-Emergent Adverse Events as of 23 December 2015;Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey;Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test,2012-004349-34;9090-14,A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC,"A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma",NULL,NULL,Interventional,,Phase 3,2013-02-04,2013-04-20,696,Terminated,Synta Pharmaceuticals Corp.,NULL,united states;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;united states;united states;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;united states;united states;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;united states;united states;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;austria;belgium;bosnia and herzegovina;canada;croatia;czech republic;france;germany;hungary;italy;netherlands;poland;romania;russian federation;serbia;slovenia;spain;ukraine;united kingdom;united states,Drug: Docetaxel;Drug: Ganetespib;Drug: Docetaxel;Drug: Ganetespib;Drug: Docetaxel;Drug: Ganetespib;Drug: Docetaxel;Drug: Ganetespib,"
Inclusion Criteria:
- Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
- Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- Documented disease progression during or following most first line therapy for
advanced disease
- Adequate hematologic, hepatic, renal function
Exclusion Criteria:
- Epidermal growth factor receptor (EGFR) mutations
- Anaplastic lymphoma kinase (ALK) translocations
- Predominantly squamous, adenosquamous or unclear histologic type
- Active or untreated central nervous system (CNS) metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or
squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- Uncontrolled intercurrent illness
;
Inclusion Criteria:
- Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
- Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- Documented disease progression during or following most first line therapy for
advanced disease
- Adequate hematologic, hepatic, renal function
Exclusion Criteria:
- Epidermal growth factor receptor (EGFR) mutations
- Anaplastic lymphoma kinase (ALK) translocations
- Predominantly squamous, adenosquamous or unclear histologic type
- Active or untreated central nervous system (CNS) metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or
squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- Uncontrolled intercurrent illness
;
Inclusion Criteria:
- Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
- Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- Documented disease progression during or following most first line therapy for
advanced disease
- Adequate hematologic, hepatic, renal function
Exclusion Criteria:
- Epidermal growth factor receptor (EGFR) mutations
- Anaplastic lymphoma kinase (ALK) translocations
- Predominantly squamous, adenosquamous or unclear histologic type
- Active or untreated central nervous system (CNS) metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or
squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- Uncontrolled intercurrent illness
;
Inclusion Criteria:
- Advanced Stage IIIB or IV non-small-cell lung cancer (NSCLC)
- Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- Documented disease progression during or following most first line therapy for
advanced disease
- Adequate hematologic, hepatic, renal function
Exclusion Criteria:
- Epidermal growth factor receptor (EGFR) mutations
- Anaplastic lymphoma kinase (ALK) translocations
- Predominantly squamous, adenosquamous or unclear histologic type
- Active or untreated central nervous system (CNS) metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or
squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- Uncontrolled intercurrent illness
",NULL,Overall Survival as of 19 October 2015;Overall Survival as of 19 October 2015,Progression-free Survival (PFS) as of 19 October 2015;Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Objective Response Rate (ORR) as of 19 October 2015;Disease Control Rate (DCR) as of 19 October 2015;Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015;Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015;Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015;Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015;Participants With Treatment-Emergent Adverse Events as of 23 December 2015;Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey;Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test,2012-004349-34 ; NCT01798485; 9090-14,2014-12-15,no,Non-Small-Cell Lung Adenocarcinoma; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic; Malignant neoplasm of bronchus and lung,Arm 1 Drug: Arm A: single agent docetaxel; Arm 2 Drug: Arm B: Combination of ganetespib and docetaxel,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,III,- Overall survival; time frame: 36 months
,- Progression-free survival; time frame: 36 months
- Objective Response Rate; time frame: 36 months
- Disease control rate; time frame: 36 months
- Duration of response; time frame: 36 months
- Symptom improvement; time frame: 36 months; Symptom improvement will be evaluated based on patient responses to quality of life questionnaires.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability; time frame: 36 months
- Exploratory biomarker analyses; time frame: 36 months; Exploratory biomarker analyses will assess correlation between biomarkers and clinical outcome.
- Emergence of metastatic lesions; time frame: 36 months
,United States; Austria; Belgium; Bosnia and Herzegovina; Canada; Croatia; Czech Republic; France; Germany; Hungary; Netherlands; Poland; Romania; Russian Federation; Serbia; Slovenia; Spain; Ukraine; United Kingdom,[---]* Bad Nauheim; [---]* Cologne; [---]* Gauting; [---]* Grosshansdorf; [---]* Leubeck; [---]* Mainz; [---]* Mannheim; [---]* Offenbach,2013-03-31,NA,850,NA,"- Advanced Stage IIIB or IV NSCLC
- Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1
- Prior therapy defined as 1 prior systemic therapy for advanced disease
- Documented disease progression during or following most first line therapy for
advanced disease
- Adequate hematologic, hepatic, renal function
","- EGFR mutations
- ALK translocations
- Predominantly squamous, adenosquamous or unclear histologic type
- Active or untreated CNS metastases
- Active malignancies other than NSCLC within the last 5 years with the exception of
adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or
squamous cell carcinoma of the skin
- Serious cardiac illness or medical conditions
- Pregnant or lactating women
- Uncontrolled intercurrent illness
","A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma",Recruiting ongoing,Synta Pharmaceuticals Corp.; [---]*; [---]*,[---]*; 9090-14_StudyInfo@SyntaPharma.com; 9090-14_StudyInfo@SyntaPharma.com,Arm 1 Drug: Arm A: single agent docetaxel; Arm 2 Drug: Arm B: Combination of ganetespib and docetaxel,2013-04-30,2013-02-04,2013-02-04,696,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2013,2016-05-26,TRUE,TRUE,TRUE
11206,NCT01299610,NA,NCT01299610,NCT: 2011-02-17 ICTRP: 2011-02-17 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 25 ICTRP: 25 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2011-02-18,NA,2010-12-01,2011-04-14,Interventional,A Study to Test the Effect of 2 Different Doses of Topical GW870086X on Atopic Dermatitis Also Including a Postive Control and a Placebo,"A Randomised, Double-blind, Placebo-controlled Study of Topical GW870086X Formulation in Subjects With Moderate or Severe Atopic Dermatitis",Completed,Phase 2,25,Actual,GlaxoSmithKline,Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22,"Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14;Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22;Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI);Number of Participants With Abnormal Electrocardiogram (ECG) of PCI;Number of Participants With Abnormal Vital Signs (Systolic and Diastolic Blood Pressure and Pulse Rate) of PCI;Pharmacokinetic Parameters: Maximum Observed Concentration (Cmax) of GW870086X;Pharmacokinetic Parameter: Time of Occurrence of Cmax (Tmax) of GW870086;Pharmacokintics Parameter: Area Under Curve (AUC) of GW870086;Pharmacodynamics Endpoint: Skin Thickness and Other Markers of Atopic Dermatitis",113434,A Study to Test the Effect of 2 Different Doses of Topical GW870086X on Atopic Dermatitis Also Including a Postive Control and a Placebo,"A Randomised, Double-blind, Placebo-controlled Study of Topical GW870086X Formulation in Subjects With Moderate or Severe Atopic Dermatitis",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2011-02-17,2010-12-01,25,Completed,GlaxoSmithKline,NULL,germany;germany;germany;germany;germany,Drug: GW870086 2.0%;Drug: GW870086 0.2%;Drug: FP 0.05%;Drug: Placebo;Drug: GW870086 2.0%;Drug: GW870086 0.2%;Drug: FP 0.05%;Drug: Placebo;Drug: GW870086 2.0%;Drug: GW870086 0.2%;Drug: FP 0.05%;Drug: Placebo;Drug: GW870086 2.0%;Drug: GW870086 0.2%;Drug: FP 0.05%;Drug: Placebo,"
Inclusion Criteria:
- Subjects with a diagnosis of atopic dermatitis who are otherwise healthy.
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal
ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy
(HRT) and whose menopausal status is in doubt will be required to use one of the
protocol contraception methods if they wish to continue their HRT during the study.
- Male subjects with female partners of child-bearing potential must agree to use one of
the protocol contraception methods.
- BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
- Subjects must have body surface area (BSA) disease involvement of >5% as assessed by
the rule of nines method.
- Patients must be willing to refrain from current active therapy for at least 10 days
prior to dosing,
- Capable of giving written informed consent.
- Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- AST and ALT < 2xULN; alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria:
- The subject presents with any systemic disorder, active skin disease or subjects who
present with scars, moles, tattoos, body piercings, sunburn in the test area which
could interfere with the assessment of lesions at screening.
- The subject has atopic dermatitis restricted to the face, the feet or the hands only.
- The subject has a current complication of atopic dermatitis for which treatment with
anti-infectives are indicated.
- History of recent (< 6 months) active or presence of current superficial skin
infections of viral aetiology
- The subject has been diagnosed as having contact dermatitis in area of target lesions,
seborrheic dermatitis and/or occupational eczema at predilection sites of atopic
dermatitis.
- The subject has had topical or transdermal treatments on or near the intended site of
application within 14 days prior to first application of study medication.
- The subject has had systemic treatment for atopic dermatitis within 28 days of the
first dose of study medication.
- Foreseeable intensive UV exposure during the study. Subjects must not be exposed to
direct sunlight or skin tanning devices for the duration of the study.
- The subject has used topical treatment with tar or any corticosteroid within 14 days
of the first dose of study medication except topical 1% hydrocortisone which may be
used twice daily in patients with severe disease who require step-down therapy during
the wash-out period until 3 days prior to study start, after which the hydrocortisone
must be discontinued.
- The subject has used topical treatment with buproprion within 14 days of the first
dose of study medication.
- History of cutaneous photodisorder.
- History of allergy to steroids or components of test medications.
- History or presence of skin (other than atopic dermatitis), hepatic or renal disease
or any other condition known to interfere with absorption, distribution, metabolism or
excretion of drugs.
- Subjects with a history of diaphoresis/excessive sweating not restricted to palms or
face.
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary
abnormalities.
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5
half-lives (whichever is longer) prior to the first dose of study medication, unless
in the opinion of the Investigator and GSK Medical Monitor the medication will not
interfere with the study procedures or compromise subject safety.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.
;
Inclusion Criteria:
- Subjects with a diagnosis of atopic dermatitis who are otherwise healthy.
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal
ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy
(HRT) and whose menopausal status is in doubt will be required to use one of the
protocol contraception methods if they wish to continue their HRT during the study.
- Male subjects with female partners of child-bearing potential must agree to use one of
the protocol contraception methods.
- BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
- Subjects must have body surface area (BSA) disease involvement of >5% as assessed by
the rule of nines method.
- Patients must be willing to refrain from current active therapy for at least 10 days
prior to dosing,
- Capable of giving written informed consent.
- Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- AST and ALT < 2xULN; alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria:
- The subject presents with any systemic disorder, active skin disease or subjects who
present with scars, moles, tattoos, body piercings, sunburn in the test area which
could interfere with the assessment of lesions at screening.
- The subject has atopic dermatitis restricted to the face, the feet or the hands only.
- The subject has a current complication of atopic dermatitis for which treatment with
anti-infectives are indicated.
- History of recent (< 6 months) active or presence of current superficial skin
infections of viral aetiology
- The subject has been diagnosed as having contact dermatitis in area of target lesions,
seborrheic dermatitis and/or occupational eczema at predilection sites of atopic
dermatitis.
- The subject has had topical or transdermal treatments on or near the intended site of
application within 14 days prior to first application of study medication.
- The subject has had systemic treatment for atopic dermatitis within 28 days of the
first dose of study medication.
- Foreseeable intensive UV exposure during the study. Subjects must not be exposed to
direct sunlight or skin tanning devices for the duration of the study.
- The subject has used topical treatment with tar or any corticosteroid within 14 days
of the first dose of study medication except topical 1% hydrocortisone which may be
used twice daily in patients with severe disease who require step-down therapy during
the wash-out period until 3 days prior to study start, after which the hydrocortisone
must be discontinued.
- The subject has used topical treatment with buproprion within 14 days of the first
dose of study medication.
- History of cutaneous photodisorder.
- History of allergy to steroids or components of test medications.
- History or presence of skin (other than atopic dermatitis), hepatic or renal disease
or any other condition known to interfere with absorption, distribution, metabolism or
excretion of drugs.
- Subjects with a history of diaphoresis/excessive sweating not restricted to palms or
face.
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary
abnormalities.
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5
half-lives (whichever is longer) prior to the first dose of study medication, unless
in the opinion of the Investigator and GSK Medical Monitor the medication will not
interfere with the study procedures or compromise subject safety.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.
;
Inclusion Criteria:
- Subjects with a diagnosis of atopic dermatitis who are otherwise healthy.
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal
ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy
(HRT) and whose menopausal status is in doubt will be required to use one of the
protocol contraception methods if they wish to continue their HRT during the study.
- Male subjects with female partners of child-bearing potential must agree to use one of
the protocol contraception methods.
- BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
- Subjects must have body surface area (BSA) disease involvement of >5% as assessed by
the rule of nines method.
- Patients must be willing to refrain from current active therapy for at least 10 days
prior to dosing,
- Capable of giving written informed consent.
- Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- AST and ALT < 2xULN; alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria:
- The subject presents with any systemic disorder, active skin disease or subjects who
present with scars, moles, tattoos, body piercings, sunburn in the test area which
could interfere with the assessment of lesions at screening.
- The subject has atopic dermatitis restricted to the face, the feet or the hands only.
- The subject has a current complication of atopic dermatitis for which treatment with
anti-infectives are indicated.
- History of recent (< 6 months) active or presence of current superficial skin
infections of viral aetiology
- The subject has been diagnosed as having contact dermatitis in area of target lesions,
seborrheic dermatitis and/or occupational eczema at predilection sites of atopic
dermatitis.
- The subject has had topical or transdermal treatments on or near the intended site of
application within 14 days prior to first application of study medication.
- The subject has had systemic treatment for atopic dermatitis within 28 days of the
first dose of study medication.
- Foreseeable intensive UV exposure during the study. Subjects must not be exposed to
direct sunlight or skin tanning devices for the duration of the study.
- The subject has used topical treatment with tar or any corticosteroid within 14 days
of the first dose of study medication except topical 1% hydrocortisone which may be
used twice daily in patients with severe disease who require step-down therapy during
the wash-out period until 3 days prior to study start, after which the hydrocortisone
must be discontinued.
- The subject has used topical treatment with buproprion within 14 days of the first
dose of study medication.
- History of cutaneous photodisorder.
- History of allergy to steroids or components of test medications.
- History or presence of skin (other than atopic dermatitis), hepatic or renal disease
or any other condition known to interfere with absorption, distribution, metabolism or
excretion of drugs.
- Subjects with a history of diaphoresis/excessive sweating not restricted to palms or
face.
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary
abnormalities.
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5
half-lives (whichever is longer) prior to the first dose of study medication, unless
in the opinion of the Investigator and GSK Medical Monitor the medication will not
interfere with the study procedures or compromise subject safety.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.
;
Inclusion Criteria:
- Subjects with a diagnosis of atopic dermatitis who are otherwise healthy.
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal
ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy
(HRT) and whose menopausal status is in doubt will be required to use one of the
protocol contraception methods if they wish to continue their HRT during the study.
- Male subjects with female partners of child-bearing potential must agree to use one of
the protocol contraception methods.
- BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
- Subjects must have body surface area (BSA) disease involvement of >5% as assessed by
the rule of nines method.
- Patients must be willing to refrain from current active therapy for at least 10 days
prior to dosing,
- Capable of giving written informed consent.
- Single QTc, QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- AST and ALT < 2xULN; alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin
>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Exclusion Criteria:
- The subject presents with any systemic disorder, active skin disease or subjects who
present with scars, moles, tattoos, body piercings, sunburn in the test area which
could interfere with the assessment of lesions at screening.
- The subject has atopic dermatitis restricted to the face, the feet or the hands only.
- The subject has a current complication of atopic dermatitis for which treatment with
anti-infectives are indicated.
- History of recent (< 6 months) active or presence of current superficial skin
infections of viral aetiology
- The subject has been diagnosed as having contact dermatitis in area of target lesions,
seborrheic dermatitis and/or occupational eczema at predilection sites of atopic
dermatitis.
- The subject has had topical or transdermal treatments on or near the intended site of
application within 14 days prior to first application of study medication.
- The subject has had systemic treatment for atopic dermatitis within 28 days of the
first dose of study medication.
- Foreseeable intensive UV exposure during the study. Subjects must not be exposed to
direct sunlight or skin tanning devices for the duration of the study.
- The subject has used topical treatment with tar or any corticosteroid within 14 days
of the first dose of study medication except topical 1% hydrocortisone which may be
used twice daily in patients with severe disease who require step-down therapy during
the wash-out period until 3 days prior to study start, after which the hydrocortisone
must be discontinued.
- The subject has used topical treatment with buproprion within 14 days of the first
dose of study medication.
- History of cutaneous photodisorder.
- History of allergy to steroids or components of test medications.
- History or presence of skin (other than atopic dermatitis), hepatic or renal disease
or any other condition known to interfere with absorption, distribution, metabolism or
excretion of drugs.
- Subjects with a history of diaphoresis/excessive sweating not restricted to palms or
face.
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary
abnormalities.
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5
half-lives (whichever is longer) prior to the first dose of study medication, unless
in the opinion of the Investigator and GSK Medical Monitor the medication will not
interfere with the study procedures or compromise subject safety.
- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or
pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior
to the first dose of study medication.
",NULL,Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22;Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22;Change From Baseline Three Item Severity (TIS) Scores Between GW870086 (0.2% and 2%) Versus Placebo at Day 22,"Change From Baseline TIS Scores Between GW870086X (0.2% and 2%) Versus Placebo on Days 2, 3, 7 and 14;Number of Investigators Global Assessment (IGA) Responders on Days 2, 3, 7, 14 and 22;Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs);Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Importance (PCI);Number of Participants With Abnormal Electrocardiogram (ECG) of PCI;Number of Participants With Abnormal Vital Signs (Systolic and Diastolic Blood Pressure and Pulse Rate) of PCI;Pharmacokinetic Parameters: Maximum Observed Concentration (Cmax) of GW870086X;Pharmacokinetic Parameter: Time of Occurrence of Cmax (Tmax) of GW870086;Pharmacokintics Parameter: Area Under Curve (AUC) of GW870086;Pharmacodynamics Endpoint: Skin Thickness and Other Markers of Atopic Dermatitis",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-12-01,2011-02-17,2011-02-17,25,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2010,2017-10-17,TRUE,FALSE,FALSE
7310,NCT01996358,NA,NCT01996358,NCT: 2013-11-22 ICTRP: 2013-11-22 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Anticipated 150 ICTRP: 150 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Review,https://doi.org/10.1111/anae.13903,NA,2013-11-27,NA,2015-08-31,NA,Interventional,Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy,Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study,Suspended,N/A,150,Anticipated,Dr. Horst Schmidt Klinik GmbH,Intubating Condition,Postoperative Myalgia,HSK004,Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy,Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study,;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). ,N/A,2013-11-22,2015-08-20,150,Suspended,Dr. Horst Schmidt Klinik GmbH,NULL,germany;germany;germany;germany;germany,"Drug: Succinylcholine;Drug: Rocuronium 0,3;Drug: Rocuronium 0,6;Drug: Succinylcholine;Drug: Rocuronium 0,3;Drug: Rocuronium 0,6;Drug: Succinylcholine;Drug: Rocuronium 0,3;Drug: Rocuronium 0,6;Drug: Succinylcholine;Drug: Rocuronium 0,3;Drug: Rocuronium 0,6",
Inclusion Criteria:
- age > 18 yr
- scheduled for elective rigid bronchoscopy
Exclusion Criteria:
- known neuromuscular disease
- significant hepatic or renal dysfunction
- family history of malignant hyperthermia
- known allergy to one of the drugs used in this protocol
- pregnancy or breastfeeding
;
Inclusion Criteria:
- age > 18 yr
- scheduled for elective rigid bronchoscopy
Exclusion Criteria:
- known neuromuscular disease
- significant hepatic or renal dysfunction
- family history of malignant hyperthermia
- known allergy to one of the drugs used in this protocol
- pregnancy or breastfeeding
;
Inclusion Criteria:
- age > 18 yr
- scheduled for elective rigid bronchoscopy
Exclusion Criteria:
- known neuromuscular disease
- significant hepatic or renal dysfunction
- family history of malignant hyperthermia
- known allergy to one of the drugs used in this protocol
- pregnancy or breastfeeding
;
Inclusion Criteria:
- age > 18 yr
- scheduled for elective rigid bronchoscopy
Exclusion Criteria:
- known neuromuscular disease
- significant hepatic or renal dysfunction
- family history of malignant hyperthermia
- known allergy to one of the drugs used in this protocol
- pregnancy or breastfeeding
,NULL,Intubating Condition;Intubating Condition;Intubating Condition,Postoperative Myalgia,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-08-31,2013-11-22,2013-11-22,150,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2017-04-03,TRUE,FALSE,FALSE
15166,NCT00638690,NA,NCT00638690,NCT: 2008-03-13 ICTRP: 2008-03-13 DRKS: NA,1,1,NA,1,1,a,Definition of progression missing; Criteria more specific in article,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 1195 ICTRP: 1195 DRKS: NA,1195,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Double,worse,0,no outcome,ganzer Artikel,https://doi.org/10.1056/nejmoa1014618,NA,2008-03-19,NA,2008-05-31,2012-10-31,Interventional,Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy",Completed,Phase 3,1195,Actual,"Cougar Biotechnology, Inc.",Overall Survival,Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria;Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%;Radiographic Progression-free Survival,COU-AA-301;CR016924,Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy",;;;,;;;,Interventional,,Phase 3,2008-03-13,2008-05-20,1195,Completed,"Cougar Biotechnology, Inc.",NULL,united states;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;united states;italy;poland;united states;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;united states;italy;poland;united states;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;united states;italy;poland;united states;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;australia;austria;belgium;canada;france;germany;hungary;ireland;netherlands;spain;united kingdom;united states;italy;poland,Drug: Placebo;Drug: Abiraterone acetate;Drug: Prednisone/prednisolone;Drug: Placebo;Drug: Abiraterone acetate;Drug: Prednisone/prednisolone;Drug: Placebo;Drug: Abiraterone acetate;Drug: Prednisone/prednisolone;Drug: Placebo;Drug: Abiraterone acetate;Drug: Prednisone/prednisolone,"
Inclusion Criteria:
- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior
cytotoxic chemotherapies
- At least one chemotherapy must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
- Medical or surgical castration with testosterone < 50 ng/dL
- Adequate bone marrow, hepatic and renal function
- Potassium >= 3.5 mmol/L
- Able to swallow the study drug whole as a tablet
- Informed Consent
Exclusion Criteria:
- More than two prior cytotoxic chemotherapy regimens
- Prior Ketoconazole for prostate cancer
- Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting
the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
- Not willing to use contraception
;
Inclusion Criteria:
- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior
cytotoxic chemotherapies
- At least one chemotherapy must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
- Medical or surgical castration with testosterone < 50 ng/dL
- Adequate bone marrow, hepatic and renal function
- Potassium >= 3.5 mmol/L
- Able to swallow the study drug whole as a tablet
- Informed Consent
Exclusion Criteria:
- More than two prior cytotoxic chemotherapy regimens
- Prior Ketoconazole for prostate cancer
- Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting
the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
- Not willing to use contraception
;
Inclusion Criteria:
- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior
cytotoxic chemotherapies
- At least one chemotherapy must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
- Medical or surgical castration with testosterone < 50 ng/dL
- Adequate bone marrow, hepatic and renal function
- Potassium >= 3.5 mmol/L
- Able to swallow the study drug whole as a tablet
- Informed Consent
Exclusion Criteria:
- More than two prior cytotoxic chemotherapy regimens
- Prior Ketoconazole for prostate cancer
- Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting
the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
- Not willing to use contraception
;
Inclusion Criteria:
- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior
cytotoxic chemotherapies
- At least one chemotherapy must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
- Medical or surgical castration with testosterone < 50 ng/dL
- Adequate bone marrow, hepatic and renal function
- Potassium >= 3.5 mmol/L
- Able to swallow the study drug whole as a tablet
- Informed Consent
Exclusion Criteria:
- More than two prior cytotoxic chemotherapy regimens
- Prior Ketoconazole for prostate cancer
- Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting
the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
- Not willing to use contraception
",NULL,Overall Survival;Overall Survival,Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria;Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%;Radiographic Progression-free Survival,NCT00638690; CR016924; COU-AA-301,2013-11-05,no,Prostatic Neoplasms; Malignant neoplasm of prostate,Arm 1 Drug: Placebo; Arm 2 Drug: Abiraterone acetate; Arm 3 Drug: Prednisone/prednisolone,Interventional,Randomized controlled trial,Blinded,Placebo,Parallel,III,- Overall Survival; time frame: Up to 60 months; Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
,"- Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria; time frame: Up to 12 months; The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart.
- Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%; time frame: Up to 12 months; A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline.
- Radiographic Progression-free Survival; time frame: Up to 11 months; Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion.
",United States; Australia; Austria; Belgium; Canada; France; Germany; Hungary; Ireland; Netherlands; Spain; United Kingdom,[---]* Aachen; [---]* Berlin; [---]* Dresden; [---]* Hamburg; [---]* Homburg/Saar,2008-05-31,NA,1195,2012-10-01,"- Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior
cytotoxic chemotherapies
- At least one chemotherapy must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) Performance Status <= 2
- Medical or surgical castration with testosterone < 50 ng/dL
- Adequate bone marrow, hepatic and renal function
- Potassium >= 3.5 mmol/L
- Able to swallow the study drug whole as a tablet
- Informed Consent
",- More than two prior cytotoxic chemotherapy regimens
- Prior Ketoconazole for prostate cancer
- Prior abiraterone acetate or other CYP17 inhibitor or investigational agents
targeting the androgen receptor for prostate cancer
- Uncontrolled hypertension
- Active or symptomatic viral hepatitis or chronic liver disease
- History of pituitary or adrenal dysfunction
- Clinically significant heart disease
- Other malignancy
- Known brain metastasis
- GI disorder affecting absorption
- Not willing to use contraception
,"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy","Recruiting complete, follow-up complete","Cougar Biotechnology, Inc.; Cougar Biotechnology, Inc.; Cougar Biotechnology, Inc.",[---]*; [---]*; [---]*,Arm 1 Drug: Placebo; Arm 2 Drug: Abiraterone acetate; Arm 3 Drug: Prednisone/prednisolone,2008-05-31,2008-03-13,2008-03-13,1195,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2008,2014-04-10,TRUE,TRUE,TRUE
9986,NCT01489111,NA,NCT01489111,NCT: 2011-11-23 ICTRP: 2011-11-23 DRKS: NA,1,1,NA,1,1,a,Criteria more specific in article,1,1,NA,4,1,no AM,5,1,NA,NCT: Actual 49 ICTRP: 49 DRKS: NA,49,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://dx.doi.org/10.1111%2Fhae.13980,NA,2011-12-09,NA,2012-08-03,2018-12-10,Interventional,Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.,Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A,Completed,Phase 3,36,Actual,Novo Nordisk A/S,"Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None",Average Consumption of N8-GP During Surgery;Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6;Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14;Average Consumption of N8-GP During the Post-operative Period Days 1-6;Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL);Estimated Blood Loss During Surgery;Number of Transfusions During the Post-operative Period Days 1-6;Length of Stay in the Hospital;Number of Days in Intensive Care;Adverse Events Reported During the Trial Period;Serious Adverse Events Reported During the Trial Period,U1111-1119-7326;2011-001144-30;132215;NN7088-3860,Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.,Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A,,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2011-11-23,2012-08-03,36,Completed,Novo Nordisk A/S,NULL,"united states;australia;brazil;bulgaria;croatia;denmark;france;germany;hungary;israel;italy;japan;malaysia;netherlands;norway;spain;sweden;switzerland;taiwan;turkey;united kingdom;australia;brazil;bulgaria;croatia;denmark;france;germany;hungary;israel;italy;japan;malaysia;netherlands;norway;spain;sweden;switzerland;taiwan;turkey;united kingdom;united states;korea, republic of;puerto rico",Drug: turoctocog alfa pegol,"
Inclusion Criteria:
- Informed consent obtained before any trial-related activities. (Trial-related
activities are any procedure that would not have been performed during normal
management of the subject.)
- Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4
(NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
- Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and
wound status for at least 3 days
- The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a
bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes
and otherwise capable of following the trial procedures
Exclusion Criteria:
- Known or suspected hypersensitivity to trial product including allergy to hamster
protein or related products
- Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4
(NN7088-3861) trial after administration of trial product, except interruption due to
inclusion in this pathfinderTM 3 trial (NN7088-3860)
- The receipt of any investigational medicinal product (except N8-GP) within 30 days
prior to enrolment into the trial. (For Brazil, only: Participation in a previous
clinical trial within one year prior to screening for this trial (Visit 1), unless
there is a direct benefit to the research subject, at the Investigator's discretion)
- FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
- Previous arterial thrombotic events (e.g. myocardial infarction and intracranial
thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by
available medical records)
- Immune modulating or chemotherapeutic medication
- Any disease (liver, kidney, inflammatory and mental disorders included) or condition
which, according to the Investigator's judgement, could imply a potential hazard to
the patient, interfere with trial participation or trial outcome
- Unwillingness, language or other barriers precluding adequate understanding and/or
cooperation
",NULL,"Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None",Average Consumption of N8-GP During Surgery;Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6;Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14;Average Consumption of N8-GP During the Post-operative Period Days 1-6;Incidence Rate of Inhibitors Against Factor VIII (FVIII) (=0.6 BU/mL);Estimated Blood Loss During Surgery;Number of Transfusions During the Post-operative Period Days 1-6;Length of Stay in the Hospital;Number of Days in Intensive Care;Adverse Events Reported During the Trial Period;Serious Adverse Events Reported During the Trial Period,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-08-03,2011-11-23,2011-11-23,36,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,2020-07-27,TRUE,FALSE,TRUE
14422,NCT00766155,NA,EUCTR2006-006532-21,NCT: 2008-10-02 ICTRP: 2008-04-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,2,NA,"no AM, no time frame, no measure",3,NA,"no time frame, no AM",NCT: Actual 1094 ICTRP: 1090 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,NA,Abstract,10.1200/jco.2014.32.15_suppl.3501,NA,2008-10-03,NA,2008-08-31,NA,Interventional,Chemotherapy and Radiation Therapy Before Surgery Followed by Capecitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced Rectal Cancer,Preoperative Chemoradiotherapy and Postoperative Chemotherapy With Capecitabine and Oxaplatin vs.Capecitabine Alone in Locally Advanced Rectal Cancer (PETACC-6),Completed,Phase 3,1094,Actual,European Organisation for Research and Treatment of Cancer - EORTC,Disease-free survival,"Overall survival within at least the first 5 years after treatment;Loco-regional failure, defined as local or regional recurrence, inoperable disease, or R1 or R2 resection;Distant failure (i.e., distant metastasis);Pathological down-stage (ypT0, 2N0) rate;Pathological complete remission (ypT0N0) rate;Tumor regression grade;Histopathological R0 resection rate;Sphincter preservation rate;Preoperative complication rate;Toxicity according to CTCAE v.3.0 weekly during treatment, at 4-8 weeks after surgery, at therapy completion, and every 6 months for 5 years after therapy completion",EU-20880;PETACC-6;ROCHE-EORTC-40054;2006-006532-21;EORTC-40054-22062;EU-20880;PETACC-6;ROCHE-EORTC-40054;2006-006532-21;EORTC-40054-22062,Chemotherapy and Radiation Therapy Before Surgery Followed by Capecitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced Rectal Cancer,Preoperative Chemoradiotherapy and Postoperative Chemotherapy With Capecitabine and Oxaplatin vs.Capecitabine Alone in Locally Advanced Rectal Cancer (PETACC-6),;;;,;;;,Interventional,"Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment",Phase 3,2008-10-02,2008-08-20,1094,Completed,European Organisation for Research and Treatment of Cancer - EORTC,NULL,germany;germany,Drug: capecitabine;Drug: oxaliplatin;Drug: capecitabine;Drug: oxaliplatin,"
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- Tumor = 12 cm from the anal verge
- Stage T3-4 or any node-positive disease
- No evidence of metastatic disease (confirmed by negative CT scan of the chest and
abdomen)
- Resectable disease or expected to become resectable after preoperative chemoradiation
- May only be randomized once in this trial
PATIENT CHARACTERISTICS:
- WHO/ECOG performance status 0-2
- Hemoglobin = 10.0 g/dL (transfusion allowed to achieve or maintain levels)
- ANC = 1,500/mm^3
- Platelet count = 100,000/mm^3
- ALT and AST = 2.5 times upper level of normal (ULN)
- Alkaline phosphatase = 2.5 times ULN
- Total bilirubin = 1.5 times ULN
- Creatinine clearance > 50 mL/min
- Creatinine = 1.5 times ULN
- Able to swallow tablets
- No prior or concurrent malignancies within the past 5 years except for adequately
treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the
skin
- No clinically significant (i.e., active) cardiac disease, including any of the
following:
- Congestive heart failure
- Symptomatic coronary artery disease
- Cardiac arrhythmia
- No myocardial infarction within the past 12 months
- No known significant impairment of intestinal resorption (e.g., chronic diarrhea,
inflammatory bowel disease)
- No pre-existing conditions that would preclude chemoradiotherapy or radiotherapy
(i.e., fistulas, severe ulcerative colitis [particularly patients currently taking
sulfasalazine], Crohn's disease, or prior adhesions)
- No peripheral neuropathy = grade 2 by CTCAE v3.0
- No serious uncontrolled intercurrent infections or other serious uncontrolled
concomitant disease
- No history of uncontrolled seizures, central nervous system disorders or psychiatric
disability that, in the opinion of the principal investigator, is clinically
significant and would preclude giving informed consent or interfere with compliance
with oral drug administration
- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior cytotoxic chemotherapy or radiation therapy for rectal cancer
- No prior radiation therapy to the pelvis
- No prior or concurrent investigational drug, agent, or procedure
- More than 4 weeks since prior participation in the active or follow-up period of
another investigational protocol
- No known allergy or any other adverse reaction to any of the study drugs or to any
related compound
- No known dihydropyrimidine dehydrogenase deficiency
- No organ allograft requiring immunosuppressive therapy
- No concurrent sorivudine or chemically related analogues (e.g., brivudine)
;
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- Tumor = 12 cm from the anal verge
- Stage T3-4 or any node-positive disease
- No evidence of metastatic disease (confirmed by negative CT scan of the chest and
abdomen)
- Resectable disease or expected to become resectable after preoperative chemoradiation
- May only be randomized once in this trial
PATIENT CHARACTERISTICS:
- WHO/ECOG performance status 0-2
- Hemoglobin = 10.0 g/dL (transfusion allowed to achieve or maintain levels)
- ANC = 1,500/mm^3
- Platelet count = 100,000/mm^3
- ALT and AST = 2.5 times upper level of normal (ULN)
- Alkaline phosphatase = 2.5 times ULN
- Total bilirubin = 1.5 times ULN
- Creatinine clearance > 50 mL/min
- Creatinine = 1.5 times ULN
- Able to swallow tablets
- No prior or concurrent malignancies within the past 5 years except for adequately
treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the
skin
- No clinically significant (i.e., active) cardiac disease, including any of the
following:
- Congestive heart failure
- Symptomatic coronary artery disease
- Cardiac arrhythmia
- No myocardial infarction within the past 12 months
- No known significant impairment of intestinal resorption (e.g., chronic diarrhea,
inflammatory bowel disease)
- No pre-existing conditions that would preclude chemoradiotherapy or radiotherapy
(i.e., fistulas, severe ulcerative colitis [particularly patients currently taking
sulfasalazine], Crohn's disease, or prior adhesions)
- No peripheral neuropathy = grade 2 by CTCAE v3.0
- No serious uncontrolled intercurrent infections or other serious uncontrolled
concomitant disease
- No history of uncontrolled seizures, central nervous system disorders or psychiatric
disability that, in the opinion of the principal investigator, is clinically
significant and would preclude giving informed consent or interfere with compliance
with oral drug administration
- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- No prior cytotoxic chemotherapy or radiation therapy for rectal cancer
- No prior radiation therapy to the pelvis
- No prior or concurrent investigational drug, agent, or procedure
- More than 4 weeks since prior participation in the active or follow-up period of
another investigational protocol
- No known allergy or any other adverse reaction to any of the study drugs or to any
related compound
- No known dihydropyrimidine dehydrogenase deficiency
- No organ allograft requiring immunosuppressive therapy
- No concurrent sorivudine or chemically related analogues (e.g., brivudine)
",NULL,Disease-free survival;Disease-free survival,"Overall survival within at least the first 5 years after treatment;Loco-regional failure, defined as local or regional recurrence, inoperable disease, or R1 or R2 resection;Distant failure (i.e., distant metastasis);Pathological down-stage (ypT0, 2N0) rate;Pathological complete remission (ypT0N0) rate;Tumor regression grade;Histopathological R0 resection rate;Sphincter preservation rate;Preoperative complication rate;Toxicity according to CTCAE v.3.0 weekly during treatment, at 4-8 weeks after surgery, at therapy completion, and every 6 months for 5 years after therapy completion;Overall survival within at least the first 5 years after treatment;Loco-regional failure, defined as local or regional recurrence, inoperable disease, or R1 or R2 resection;Distant failure (i.e., distant metastasis);Pathological down-stage (ypT0, 2N0) rate;Pathological complete remission (ypT0N0) rate;Tumor regression grade;Histopathological R0 resection rate;Sphincter preservation rate;Preoperative complication rate;Toxicity according to CTCAE v.3.0 weekly during treatment, at 4-8 weeks after surgery, at therapy completion, and every 6 months for 5 years after therapy completion",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-08-31,2008-10-02,2008-10-02,1094,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2008,2016-10-11,TRUE,FALSE,TRUE
8494,NCT01759329,NA,NCT01759329,NCT: 2012-12-21 ICTRP: 2012-12-21 DRKS: NA,1,1,NA,2,1,NA,NA,1,1,NA,3,1,"no AM, no metric",NA,NA,NA,NCT: Actual 118 ICTRP: 118 DRKS: NA,118 randomized,1,1,2,0,NA,"Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)",Triple blinding,worse,0,"no outcome (outcome is weight according to register and ""health effects"" according to title)",ganzer Artikel,https://doi.org/10.1007/s00394-014-0763-3,NA,2013-01-03,NA,2011-01-31,2011-12-31,Interventional,Health Effects of Coffee Consumption,Health Effects of Coffee Consumption,Completed,N/A,118,Actual,West German Center of Diabetes and Health,body weight,,DüsselKaffee,Health Effects of Coffee Consumption,Health Effects of Coffee Consumption,,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care",N/A,2012-12-21,2011-01-20,118,Completed,West German Center of Diabetes and Health,Tchibo GmbH,germany,Dietary Supplement: test coffee;Dietary Supplement: control coffee,
Inclusion Criteria:
- age 18-69 years
- BMI =27 kg/m2
- coffee consumption of =3 cups per day
Exclusion Criteria:
- new diagnosed type 2 diabetes during the last 6 months
- severe diseases with hospital stay during the last 3 months
- change of body weight of more than 2 kg per week during the last 4 weeks
- smoking cessation during the last 3 months or planned during the study
- acute infects
- chronical diseases with except of type 2 diabetes mellitus
- regular pharmacological therapy with except of oral antidiabetic medication or
contraception
- lack of contraception in women
- breastfeeding
- physical activity of more than 1 hour per day
,NULL,body weight,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-01-31,2012-12-21,2012-12-21,118,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2011,2012-12-28,TRUE,FALSE,FALSE
7738,NCT01908829,NA,NCT01908829,NCT: 2013-07-24 ICTRP: 2013-07-24 DRKS: NA,1,1,NA,2,NA,NA,NA,2,NA,"Dosages are given, but unable to control trial design due to rather complex sequence of dosages and arms",4,1,no AM,4,1,no AM,NCT: Actual 2174 ICTRP: 2174 DRKS: NA,2174,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1016/j.eururo.2016.02.030,NA,2013-07-26,NA,2013-07-10,2014-11-25,Interventional,A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin),"A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms",Completed,Phase 3,2174,Actual,Astellas Pharma Inc,Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours,"Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours;Change From Baseline in Mean Number of Micturitions Per 24 Hours;Number of Incontinence Episodes Reported During the 3-Day Diary;Change From Baseline in Mean Volume Voided (MVV) Per Micturition;Change From Baseline to EoT in Corrected Micturition Frequency (CMF);Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours;Number of UI Episodes Reported During the 3-Day Diary;Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours;Change From Baseline in Mean Number of Pads Per 24 Hours;Number of Pads Used During the 3-Day Diary;Change From Baseline in Mean Number of Nocturia Episodes;Number of Nocturia Episodes Reported Over 3-Day Diary;Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression;Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score;Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score;Change From Baseline in OAB-q HRQL Subscale Score: Coping;Change From Baseline in OAB-q HRQL Subscale Score: Concern;Change From Baseline in OAB-q HRQL Subscale Score: Sleep;Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction;Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score;Change From Baseline in Patient Perception Bladder Control (PPBC) Score;Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC);Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours;Percentage of Participants With Zero Incontinence Episodes Postbaseline;Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline;Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score;Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score;Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC;Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC;Number of Participants With Adverse Events (AEs);Change From Baseline in Post Void Residual (PVR) Volume",2012-005401-41;905-EC-012,A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin),"A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2013-07-24,2013-07-10,2174,Completed,Astellas Pharma Europe Ltd.,NULL,united states;armenia;australia;austria;belgium;canada;czechia;denmark;finland;france;georgia;germany;greece;hungary;ireland;israel;italy;lebanon;netherlands;norway;poland;portugal;romania;russian federation;slovakia;slovenia;spain;sweden;switzerland;turkey;united kingdom;armenia;australia;austria;belgium;canada;czechia;denmark;finland;france;georgia;germany;greece;hungary;ireland;israel;italy;lebanon;netherlands;norway;poland;portugal;romania;russian federation;slovakia;slovenia;spain;sweden;switzerland;turkey;united kingdom;united states;algeria;czech republic;egypt;jordan;kazakhstan;taiwan;ukraine,Drug: mirabegron 25 mg;Drug: mirabegron 50 mg;Drug: solifenacin 5 mg;Drug: solifenacin 10 mg;Drug: mirabegron 25 mg matching placebo;Drug: mirabegron 50 mg matching placebo;Drug: solifenacin 5 mg matching placebo;Drug: solifenacin 10 mg matching placebo,"
Inclusion Criteria:
- Main Inclusion at Screening:
1. Subject has symptoms of OAB (urinary frequency and urgency with urgency
incontinence) for >= 3 months prior to the screening visit
2. Subject is willing and able to complete the micturition diary and questionnaires
correctly, including collection and measurement of urine output for 3 days prior
to each visit;
3. Subject has symptoms of wet OAB (urinary frequency and urgency with
incontinence or mixed incontinence with predominant urgency incontinence), and
reports an average of at least 2 incontinence episodes per day.
- Main Inclusion at Run-in (Visit 2):
1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with
or without incontinence per 24-hour period during the 3-day micturition diary
period.
2. Subject experiences on average at least 2 incontinence episodes per 24-hour
period during the 3-day micturition diary period.
3. Subject experiences on average at least 8 micturitions (excluding incontinence
episodes) per 24-hour period during the 3-day micturition diary period.
- Main Inclusion at Randomization (Visit 3):
1. Subject experiences at least 1 incontinence episode during the 3-day micturition
diary period and wishes to increase their treatment for OAB symptoms.
Exclusion Criteria:
- Main Exclusion at Screening:
1. Subject in the opinion of the investigator has clinically significant Bladder
Outlet Obstruction (BOO).
2. Subject has significant Post-void residual (PVR) volume (PVR > 150 ml).
3. Subject has significant stress incontinence or mixed stress/urgency incontinence
where stress is the predominant factor as determined by the investigator
4. Subject has an indwelling catheter or practices intermittent self
catheterization.
5. Subject has evidence of a UTI.
6. Subject has chronic inflammation such as interstitial cystitis, bladder stones,
previous pelvic radiation therapy, or previous or current malignant disease of
the pelvic organs
7. Subject has moderate to severe hepatic impairment
8. Subject has severe renal impairment or End Stage Renal disease
9. Subject has a clinically significant abnormal Electrocardiogram (ECG)
10. Subject has a concurrent malignancy or history of cancer (except noninvasive skin
cancer) within the last 5 years prior to screening.
11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at
risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
12. Subject has received intravesical treatment in the past 12 months with e.g.,
botulinum toxin, resiniferatoxin, capsaicin.
13. Subject has severe uncontrolled hypertension, which is defined as a sitting
average systolic blood pressure = 180 mmHg and/or average diastolic blood
pressure = 110 mmHg.
- Main Exclusion at Randomization (visit 3):
1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence
episodes are recorded in the 3 day diary administered for 3 days prior to Visit
3).
2. Subject does not desire an increase in study medication.
3. Subject has an average total daily urine volume > 3000ml as recorded in the
micturition diary.
4. Subject has severe uncontrolled hypertension, which is defined as a sitting
average systolic blood pressure = 180 mmHg and/or average diastolic blood
pressure = 110 mmHg.
5. Subject has a clinically significant abnormal ECG
",NULL,Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours,"Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours;Change From Baseline in Mean Number of Micturitions Per 24 Hours;Number of Incontinence Episodes Reported During the 3-Day Diary;Change From Baseline in Mean Volume Voided (MVV) Per Micturition;Change From Baseline to EoT in Corrected Micturition Frequency (CMF);Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours;Number of UI Episodes Reported During the 3-Day Diary;Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours;Change From Baseline in Mean Number of Pads Per 24 Hours;Number of Pads Used During the 3-Day Diary;Change From Baseline in Mean Number of Nocturia Episodes;Number of Nocturia Episodes Reported Over 3-Day Diary;Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort;Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression;Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score;Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score;Change From Baseline in OAB-q HRQL Subscale Score: Coping;Change From Baseline in OAB-q HRQL Subscale Score: Concern;Change From Baseline in OAB-q HRQL Subscale Score: Sleep;Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction;Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score;Change From Baseline in Patient Perception Bladder Control (PPBC) Score;Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC);Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours;Percentage of Participants With Zero Incontinence Episodes Postbaseline;Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline;Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score;Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score;Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC;Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC;Number of Participants With Adverse Events (AEs);Change From Baseline in Post Void Residual (PVR) Volume",NCT01908829; 905-EC-012; 2012-005401-41,2015-04-20,no,Urinary Bladder Overactive; Urinary Bladder Diseases; Urologic Diseases; Other specified disorders of bladder,Arm 1 Drug: Mirabegron; Arm 2 Drug: Solifenacin succinate low dose; Arm 3 Drug: Solifenacin succinate high dose,Interventional,Randomized controlled trial,Blinded,Active control (effective treament of control group),Parallel,III,- Change from Baseline in mean number of incontinence episodes per 24 hours; time frame: Baseline to end of treatment (12 weeks)
,- Change from baseline in mean number of micturitions per 24 hours; time frame: Baseline to end of treatment (12 weeks)
- Number of incontinence episodes reported over 3-day diary; time frame: End of treatment (12 weeks)
- Change from baseline in mean volume voided per micturition; time frame: Baseline to end of treatment (12 weeks)
- Change from baseline in mean number of urgency incontinence episodes per 24 hours; time frame: Baseline to end of treatment (12 weeks)
- Number of urgency incontinence episodes reported over 3-day diary; time frame: End of treatment (12 weeks)
- Change from baseline in mean number of urgency episodes (grade 3 or 4) per 24 hours; time frame: Baseline to end of treatment (12 weeks)
- Change from baseline in mean number of pads per 24 hours; time frame: Baseline to end of treatment (12 weeks)
- Number of pads reported over 3-day diary; time frame: End of treatment (12 weeks)
- Change from baseline in mean number of nocturia Episodes reported in 3-day diary; time frame: Baseline to end of treatment (12 weeks)
- Number of nocturia episodes reported over 3-day diary; time frame: End of treatment (12 weeks)
- Proportion of subjects with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours; time frame: Baseline to end of treatment (12 weeks)
- Proportion of subjects with zero incontinence episodes per 24 hrs at End of Treatment; time frame: End of treatment (12 weeks)
- Proportion of subjects with a mean of less than 8 micturitions per 24 hours at End of Treatment; time frame: End of treatment (12 weeks)
- Change from baseline in total Euroqol European Quality of Life-5 Dimensions (EQ-5D) score (and subscale scores); time frame: Baseline to end of treatment (12 weeks)
- Change from baseline in total OAB-q score (and subscale scores); time frame: Baseline to end of treatment (12 weeks)
- Proportion of responders with at least a 10-point improvement from Baseline in OAB-q subscales; time frame: Baseline to end of treatment (12 weeks)
- Change from baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) score; time frame: Baseline to end of treatment (12 weeks)
- Change from baseline in Patient Perception Bladder Control (PPBC) score; time frame: Baseline to end of treatment (12 weeks)
- Proportion of subjects with at least a 1-point improvement from baseline in PPBC; time frame: End of treatment (12 weeks)
- Proportion of subjects with major (at least 2-point) improvement from baseline in PPBC; time frame: End of treatment (12 weeks)
- Patient and Clinician Global Impression of Change Scales (PGIC and CGIC); time frame: End of treatment (12 weeks)
,Armenia; Australia; Austria; Belgium; Canada; Czech Republic; Denmark; Finland; France; Georgia; Germany; Greece; Hungary; Ireland; Israel; Italy; Lebanon; Netherlands; Norway; Poland,[---]* Bad Ems; [---]* Berlin; [---]* Hagenow; [---]* Halle (Saale); [---]* Hamburg; [---]* Henningsdorf; [---]* Hettstedt; [---]* Koblenz; [---]* Lutherstadt Eisleben; [---]* Reutlingen; [---]* Sangerhausen,2013-07-31,NA,2172,2014-11-01,"- Main Inclusion at Screening:
1. Subject has symptoms of OAB (urinary frequency and urgency with urgency
incontinence) for >= 3 months prior to the screening visit
2. Subject is willing and able to complete the micturition diary and questionnaires
correctly, including collection and measurement of urine output for 3 days prior
to each visit;
3. Subject has symptoms of ""wet"" OAB (urinary frequency and urgency with
incontinence or mixed incontinence with predominant urgency incontinence), and
reports an average of at least 2 incontinence episodes per day.
- Main Inclusion at Run-in (Visit 2):
1. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with
or without incontinence per 24-hour period during the 3-day micturition diary
period.
2. Subject experiences on average at least 2 incontinence episodes per 24-hour
period during the 3-day micturition diary period.
3. Subject experiences on average at least 8 micturitions (excluding incontinence
episodes) per 24-hour period during the 3-day micturition diary period.
- Main Inclusion at Randomization (Visit 3):
1. Subject experiences at least 1 incontinence episode during the 3-day micturition
diary period and wishes to increase their treatment for OAB symptoms.
","- Main Exclusion at Screening:
1. Subject in the opinion of the investigator has clinically significant Bladder
Outlet Obstruction (BOO).
2. Subject has significant Post-void residual (PVR) volume (PVR > 150 ml).
3. Subject has significant stress incontinence or mixed stress/urgency incontinence
where stress is the predominant factor as determined by the investigator
4. Subject has an indwelling catheter or practices intermittent self
catheterization.
5. Subject has evidence of a UTI.
6. Subject has chronic inflammation such as interstitial cystitis, bladder stones,
previous pelvic radiation therapy, or previous or current malignant disease of
the pelvic organs
7. Subject has moderate to severe hepatic impairment
8. Subject has severe renal impairment or End Stage Renal disease
9. Subject has a clinically significant abnormal Electrocardiogram (ECG)
10. Subject has a concurrent malignancy or history of cancer (except noninvasive
skin cancer) within the last 5 years prior to screening.
11. Subject has a QTcF interval > 450 ms for males or > 470 ms for females or is at
risk of QT prolongation (e.g., family history of long QT syndrome,
hypokalaemia).
12. Subject has received intravesical treatment in the past 12 months with e.g.,
botulinum toxin, resiniferatoxin, capsaicin.
13. Subject has severe uncontrolled hypertension, which is defined as a sitting
average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood
pressure ≥ 110 mmHg.
- Main Exclusion at Randomization (visit 3):
1. Subject has achieved 100% continence from Visit 2 to Visit 3 (no incontinence
episodes are recorded in the 3 day diary administered for 3 days prior to Visit
3).
2. Subject does not desire an increase in study medication.
3. Subject has an average total daily urine volume > 3000ml as recorded in the
micturition diary.
4. Subject has severe uncontrolled hypertension, which is defined as a sitting
average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood
pressure ≥ 110 mmHg.
5. Subject has a clinically significant abnormal ECG
","A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms","Recruiting complete, follow-up complete",Astellas Pharma Europe Ltd.; Astellas Pharma Europe Ltd.; Astellas Pharma Europe Ltd.,[---]*; [---]*; [---]*,Arm 1 Drug: Mirabegron; Arm 2 Drug: Solifenacin succinate low dose; Arm 3 Drug: Solifenacin succinate high dose,2013-07-10,2013-07-24,2013-07-24,2174,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2013,2018-07-18,TRUE,TRUE,FALSE
4789,NCT02550418,NA,NCT02550418,NCT: 2015-09-14 ICTRP: 2015-09-14 DRKS: NA,1,1,NA,2,1,a,Criteria more specific in article,1,1,NA,5,1,NA,4,1,no measure,NCT: Actual 60 ICTRP: 60 DRKS: NA,61,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1177%2F2050640620962632,NA,2015-09-15,NA,2015-10-31,2017-03-31,Interventional,Budesonide 9 mg Capsules in Active UC,"Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis",Completed,Phase 2,60,Actual,Dr. Falk Pharma GmbH,Rate of clinical remission at final/withdrawal visit,Rate of endoscopic remission/improvement at final/withdrawal visit;Number of stools / bloody stools per week,BUX-3/UCA,Budesonide 9 mg Capsules in Active UC,"Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis",;;;;,;;;;,Interventional,Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2015-09-14,2015-10-20,60,Completed,Dr. Falk Pharma GmbH,NULL,germany;germany;germany;germany;germany,Drug: Budesonide;Drug: Budesonide;Drug: Budesonide;Drug: Budesonide,"
Inclusion Criteria:
- Signed informed consent,
- Men or women aged 18 to 75 years,
- Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by
endoscopy and histology,
- Established disease,
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis,
microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete
microscopic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
toxin in stool culture at screening),
- Malabsorption syndromes,
- Celiac disease,
- Bleeding hemorrhoids,
- Active peptic ulcer disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
may cause diarrhea or gastrointestinal bleeding,
- Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma,
cataract, or infection if careful medical monitoring is not ensured,
- Any severe infectious disease (e.g., tuberculosis, AIDS),
- Severe co-morbidity substantially reducing life expectancy,
- History of colorectal cancer,
- History of cancer (other than colorectal) in the last 5 years, except for basal cell
carcinoma
;
Inclusion Criteria:
- Signed informed consent,
- Men or women aged 18 to 75 years,
- Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by
endoscopy and histology,
- Established disease,
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis,
microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete
microscopic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
toxin in stool culture at screening),
- Malabsorption syndromes,
- Celiac disease,
- Bleeding hemorrhoids,
- Active peptic ulcer disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
may cause diarrhea or gastrointestinal bleeding,
- Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma,
cataract, or infection if careful medical monitoring is not ensured,
- Any severe infectious disease (e.g., tuberculosis, AIDS),
- Severe co-morbidity substantially reducing life expectancy,
- History of colorectal cancer,
- History of cancer (other than colorectal) in the last 5 years, except for basal cell
carcinoma
;
Inclusion Criteria:
- Signed informed consent,
- Men or women aged 18 to 75 years,
- Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by
endoscopy and histology,
- Established disease,
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis,
microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete
microscopic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
toxin in stool culture at screening),
- Malabsorption syndromes,
- Celiac disease,
- Bleeding hemorrhoids,
- Active peptic ulcer disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
may cause diarrhea or gastrointestinal bleeding,
- Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma,
cataract, or infection if careful medical monitoring is not ensured,
- Any severe infectious disease (e.g., tuberculosis, AIDS),
- Severe co-morbidity substantially reducing life expectancy,
- History of colorectal cancer,
- History of cancer (other than colorectal) in the last 5 years, except for basal cell
carcinoma
;
Inclusion Criteria:
- Signed informed consent,
- Men or women aged 18 to 75 years,
- Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by
endoscopy and histology,
- Established disease,
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis,
microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete
microscopic colitis), diverticular disease associated colitis,
- Toxic megacolon or fulminant colitis,
- Colon resection,
- Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
toxin in stool culture at screening),
- Malabsorption syndromes,
- Celiac disease,
- Bleeding hemorrhoids,
- Active peptic ulcer disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
may cause diarrhea or gastrointestinal bleeding,
- Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma,
cataract, or infection if careful medical monitoring is not ensured,
- Any severe infectious disease (e.g., tuberculosis, AIDS),
- Severe co-morbidity substantially reducing life expectancy,
- History of colorectal cancer,
- History of cancer (other than colorectal) in the last 5 years, except for basal cell
carcinoma
",NULL,Rate of clinical remission at final/withdrawal visit;Rate of clinical remission at final/withdrawal visit;Rate of clinical remission at final/withdrawal visit,Rate of endoscopic remission/improvement at final/withdrawal visit;Number of stools / bloody stools per week,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-10-31,2015-09-14,2015-09-14,60,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2017-07-25,TRUE,FALSE,TRUE
15272,NCT00621244,NA,NA,NCT: 2008-02-12 ICTRP: NA DRKS: NA,0,NA,registered as single group assignment but has three arms,1,NA,NA,NA,1,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 175 ICTRP: NA DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Review,https://dx.doi.org/10.2147%2FOTT.S87962,NA,2008-02-22,NA,2003-03-01,2009-12-03,Interventional,A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies,"A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies",Completed,Phase 1/Phase 2,175,Actual,Novartis,Number of Participants DLT in Arm 1 in Dose Escalation Phase;Number of Participants DLT in Arm 2 in Dose Escalation Phase,"Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML);Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase;Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD);Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS);Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2;Half Life of Panobinostat After the First Dose in Arms 1 and 2;Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15;Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15;Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X;Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y;Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week);Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)",2005-003670-26;CLBH589B2102,A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies,"A Phase IA/II, Two-arm, Multi-center, Open-label, Dose-escalation Study of LBH589 Administered Orally Via Different Dosing Schedules in Adult Patients With Advanced Hematological Malignancies",;;;;,;;;;,Interventional,Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1/Phase 2,2008-02-12,2003-03-01,175,Completed,Novartis Pharmaceuticals,NULL,united states;australia;germany;australia;germany;united states;united states;australia;germany;australia;germany;united states;united states;australia;germany;australia;germany;united states;united states;australia;germany;australia;germany;united states;united states;australia;germany;australia;germany;united states,Drug: LBH589;Drug: LBH589;Drug: LBH589;Drug: LBH589,"
Inclusion criteria:
- Adult patients (=18 years old) with advanced hematological malignancies who relapsed
after or are refractory to standard therapy, or for which no standard therapy existed;
or, were considered inappropriate candidates for standard therapy
- World Health Organization (WHO) performance status = 2
- Patients who met protocol-specified hematologic and non-hematologic laboratory values
- Patients with adequate liver and renal function
Exclusion criteria:
- Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
- Peripheral neuropathy = CTCAE grade 2
- Unresolved diarrhea = CTCAE grade 2
- Concurrent severe and/or uncontrolled medical conditions which could compromise
participation in the study, including impaired heart function or clinically
significant heart disease, and impaired gastrointestinal function or disease that
significantly altered aborption of LBH589
- Female patients who were pregnant or breast feeding
- Patients who were unwilling to use an effective method of birth control
- Patients who took medications specified by the protocol as prohibited for
administration in combination with LBH589
- Patients with another primary malignancy that required active intervention or were
clinically significant
;
Inclusion criteria:
- Adult patients (=18 years old) with advanced hematological malignancies who relapsed
after or are refractory to standard therapy, or for which no standard therapy existed;
or, were considered inappropriate candidates for standard therapy
- World Health Organization (WHO) performance status = 2
- Patients who met protocol-specified hematologic and non-hematologic laboratory values
- Patients with adequate liver and renal function
Exclusion criteria:
- Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
- Peripheral neuropathy = CTCAE grade 2
- Unresolved diarrhea = CTCAE grade 2
- Concurrent severe and/or uncontrolled medical conditions which could compromise
participation in the study, including impaired heart function or clinically
significant heart disease, and impaired gastrointestinal function or disease that
significantly altered aborption of LBH589
- Female patients who were pregnant or breast feeding
- Patients who were unwilling to use an effective method of birth control
- Patients who took medications specified by the protocol as prohibited for
administration in combination with LBH589
- Patients with another primary malignancy that required active intervention or were
clinically significant
;
Inclusion criteria:
- Adult patients (=18 years old) with advanced hematological malignancies who relapsed
after or are refractory to standard therapy, or for which no standard therapy existed;
or, were considered inappropriate candidates for standard therapy
- World Health Organization (WHO) performance status = 2
- Patients who met protocol-specified hematologic and non-hematologic laboratory values
- Patients with adequate liver and renal function
Exclusion criteria:
- Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
- Peripheral neuropathy = CTCAE grade 2
- Unresolved diarrhea = CTCAE grade 2
- Concurrent severe and/or uncontrolled medical conditions which could compromise
participation in the study, including impaired heart function or clinically
significant heart disease, and impaired gastrointestinal function or disease that
significantly altered aborption of LBH589
- Female patients who were pregnant or breast feeding
- Patients who were unwilling to use an effective method of birth control
- Patients who took medications specified by the protocol as prohibited for
administration in combination with LBH589
- Patients with another primary malignancy that required active intervention or were
clinically significant
;
Inclusion criteria:
- Adult patients (=18 years old) with advanced hematological malignancies who relapsed
after or are refractory to standard therapy, or for which no standard therapy existed;
or, were considered inappropriate candidates for standard therapy
- World Health Organization (WHO) performance status = 2
- Patients who met protocol-specified hematologic and non-hematologic laboratory values
- Patients with adequate liver and renal function
Exclusion criteria:
- Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
- Peripheral neuropathy = CTCAE grade 2
- Unresolved diarrhea = CTCAE grade 2
- Concurrent severe and/or uncontrolled medical conditions which could compromise
participation in the study, including impaired heart function or clinically
significant heart disease, and impaired gastrointestinal function or disease that
significantly altered aborption of LBH589
- Female patients who were pregnant or breast feeding
- Patients who were unwilling to use an effective method of birth control
- Patients who took medications specified by the protocol as prohibited for
administration in combination with LBH589
- Patients with another primary malignancy that required active intervention or were
clinically significant
",NULL,Number of Participants DLT in Arm 1 in Dose Escalation Phase;Number of Participants DLT in Arm 2 in Dose Escalation Phase;Number of Participants DLT in Arm 1 in Dose Escalation Phase;Number of Participants DLT in Arm 2 in Dose Escalation Phase;Number of Participants DLT in Arm 1 in Dose Escalation Phase;Number of Participants DLT in Arm 2 in Dose Escalation Phase,"Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML);Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase;Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD);Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS);Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2;Half Life of Panobinostat After the First Dose in Arms 1 and 2;Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15;Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15;Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y;Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X;Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y;Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week);Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-03-01,2008-02-12,2008-02-12,175,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,2017-07-17,TRUE,FALSE,TRUE
26037,NCT00010270,DRKS00005511,DRKS00005511,NCT: NA ICTRP: 2014-02-11 DRKS: 2014-02-11,1,NA,NA,2,NA,NA,NA,1,NA,info from description,5,NA,info from description,1,NA,some additional outcomes given in description without details,NCT: NA ICTRP: 50 DRKS: [---]* 50,NA,1,0,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2003-01-27,NA,2001-04-30,NA,Interventional,"LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer","A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma",Unknown status,Phase 1,50,Anticipated,National Cancer Institute (NCI),NA,NA,UFMC-431;UFMC-IND-7697;UFMC-NSC-691236;NCI-431;EU-20120;CDR0000068462,"LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer","A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma",,,Interventional,Primary Purpose: Treatment,Phase 1,2001-02-02,2001-04-20,50,"Active, not recruiting",University Hospital Freiburg,National Cancer Institute (NCI),germany,Biological: LMB-9 immunotoxin,"
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced adenocarcinoma of the colon,
rectum, pancreas, esophagus, or stomach that is refractory to standard treatment
- Overexpression of the Lewis-Y antigen
- Measurable or evaluable disease
- No CNS metastasis
- Metastatic liver disease from primary tumor allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Absolute granulocyte count greater than 1,200/mm^3
Hepatic:
- Bilirubin normal
- SGOT and SGPT no greater than 1.5 times upper limit of normal
- Hepatitis B or C antigen negative
- No liver disease (e.g., alcohol liver disease)
- Albumin at least 3.0 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL
- Creatinine clearance at least 60 mL/min
- Proteinuria no greater than 1 g/24 hours (grade II toxicity-like)
Cardiovascular:
- No prior coronary artery disease
- No New York Heart Association class II, III, or IV congestive heart failure
- No arrhythmia requiring treatment
Pulmonary:
- FEV_1 and FVC greater than 65% predicted
Other:
- No other concurrent malignancy
- No active peptic ulcer disease
- No known allergy to omeprazole
- No known seizure disorder
- No concurrent medical or psychiatric condition that would preclude study
participation
- No contraindication to pressor therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
",NULL,NULL,NULL,NCT00010270; CDR0000068462; UFMC-431; UFMC-IND-7697; UFMC-NSC-691236,2014-02-11,yes,Colorectal Cancer; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Malignant neoplasm of rectum,Arm 1 Biological: LMB-9 immunotoxin,Interventional,NA,NA,NA,NA,I,NA,NA,Germany,[---]* Freiburg,2001-04-30,NA,50,NA,"DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced adenocarcinoma of the colon,
rectum, pancreas, esophagus, or stomach that is refractory to standard treatment
- Overexpression of the Lewis-Y antigen
- Measurable or evaluable disease
- No CNS metastasis
- Metastatic liver disease from primary tumor allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Absolute granulocyte count greater than 1,200/mm^3
Hepatic:
- Bilirubin normal
- SGOT and SGPT no greater than 1.5 times upper limit of normal
- Hepatitis B or C antigen negative
- No liver disease (e.g., alcohol liver disease)
- Albumin at least 3.0 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL
- Creatinine clearance at least 60 mL/min
- Proteinuria no greater than 1 g/24 hours (grade II toxicity-like)
Cardiovascular:
- No prior coronary artery disease
- No New York Heart Association class II, III, or IV congestive heart failure
- No arrhythmia requiring treatment
Pulmonary:
- FEV_1 and FVC greater than 65% predicted
Other:
- No other concurrent malignancy
- No active peptic ulcer disease
- No known allergy to omeprazole
- No known seizure disorder
- No concurrent medical or psychiatric condition that would preclude study
participation
- No contraindication to pressor therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
",NA,"A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma","Recruiting complete, follow-up continuing",University Hospital Freiburg; Kreiskrankenhaus Emmendingen; Kreiskrankenhaus Emmendingen,[---]*; [---]*; [---]*,Arm 1 Biological: LMB-9 immunotoxin,2001-04-30,2001-02-02,2001-02-02,50,Interventional,FALSE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,TRUE,TRUE,TRUE,2001,2013-12-18,TRUE,TRUE,FALSE
17028,NCT00334685,NA,NCT00334685,NCT: 2006-06-07 ICTRP: 2006-06-07 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA 354 ICTRP: 354 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2006-06-08,NA,2006-08-22,2007-10-11,Interventional,"[S,S]-Reboxetine Add-On Trial","[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.",Terminated,Phase 2,136,Actual,Pfizer,The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated,The mean endpoint (week 10) sleep interference score change from baseline;Analysis of the Medical Outcomes Study Sleep Scale;Analysis of the Patient Global Impression of Change;Analysis of the Neuropathic Pain Symptom Inventory,A6061021,"[S,S]-Reboxetine Add-On Trial","[S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin.",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2006-06-07,2006-08-22,136,Terminated,Pfizer,NULL,united states;austria;canada;czechia;germany;italy;latvia;netherlands;norway;poland;russian federation;spain;sweden;switzerland;ukraine;united kingdom;austria;canada;czechia;germany;italy;latvia;netherlands;norway;poland;russian federation;spain;sweden;switzerland;ukraine;united kingdom;united states;czech republic,"Drug: [S,S]-Reboxetine + Pregabalin;Drug: Pregabalin","
Inclusion Criteria:
- Patients must have pain present for more than 3 months after the healing of shingles
skin rash
- Patients at screening must have a score >/=40 mm on the pain visual analogue scale
Exclusion Criteria:
- Patients with significant renal and hepatic impairment
- Patients with other severe pain, that may impair the self-assessment of the pain due
to shingles
- Patients with clinically abnormal electrocardiogram
",NULL,The numerical pain intensity rating scale is used to assess pain and a change from baseline in pain score for week 10 will be calculated,The mean endpoint (week 10) sleep interference score change from baseline;Analysis of the Medical Outcomes Study Sleep Scale;Analysis of the Patient Global Impression of Change;Analysis of the Neuropathic Pain Symptom Inventory,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-08-22,2006-06-07,2006-06-07,136,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2006,2019-12-12,TRUE,FALSE,TRUE
5466,NCT02397473,NA,NCT02397473,NCT: 2015-03-19 ICTRP: 2015-03-19 DRKS: NA,1,1,NA,2,0,NA,"Inclusion criteria differ a bit, for example register ""with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1 month"" vs. In article ""required to have had a cluster headache period that had lasted at least 6 weeks""",2,1,NA,5,1,NA,5,1,NA,NCT: Actual 109 ICTRP: 109 DRKS: NA,106,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,0,no outcome,ganzer Artikel,https://doi.org/10.1056/nejmoa1813440,NA,2015-03-25,NA,2015-05-22,2018-06-04,Interventional,A Study Of Galcanezumab In Participants With Episodic Cluster Headache,"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache",Completed,Phase 3,109,Actual,Eli Lilly and Company,Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks,Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks;Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks;Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I);Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I);Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks;Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks;Pharmacokinetics (PK): Serum Concentration of Galcanezumab;Pharmacokinetics (PK): Serum Concentration of Galcanezumab;Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab;Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS);Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS),I5Q-MC-CGAL;2015-000149-22;15780,A Study Of Galcanezumab In Participants With Episodic Cluster Headache,"A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2015-03-19,2015-05-22,109,Completed,Eli Lilly and Company,NULL,united states;belgium;canada;denmark;finland;france;germany;greece;italy;netherlands;spain;united kingdom;belgium;canada;denmark;finland;france;germany;greece;italy;netherlands;spain;united kingdom;united states,Drug: Galcanezumab;Drug: Placebo,"
Inclusion Criteria:
- Have a diagnosis of cluster headache as defined by International Headache Society
(IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with
a history of episodic cluster headache with at least two cluster periods lasting from
7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1
month.
- Participants are able to distinguish cluster headache attacks from other headaches.
Exclusion Criteria:
- Current enrollment in or discontinuation within the last 30 days from, a clinical
trial involving any investigational drug or device.
- Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
- Are taking indomethacin and/or are suspected of having another distinct trigeminal
autonomic cephalalgia.
- A history of migraine variants that could implicate or could be confused with
ischemia.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
proteins.
- A history or presence of other medical illness that indicates a medical problem that
would preclude study participation.
- Evidence of significant active or unstable psychiatric disease, in the opinion of the
investigator.
- Women who are pregnant or nursing.
",NULL,Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks,Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks;Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks;Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I);Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I);Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks;Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks;Pharmacokinetics (PK): Serum Concentration of Galcanezumab;Pharmacokinetics (PK): Serum Concentration of Galcanezumab;Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab;Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS);Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-05-22,2015-03-19,2015-03-19,109,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,2019-08-26,TRUE,FALSE,TRUE
17035,NCT00334139,NA,NCT00334139,NCT: 2006-06-02 ICTRP: 2006-06-02 DRKS: NA,1,1,NA,1,1,a,criteria more specific in article,1,1,NA,2,1,"no AM, no metric, no measure",4,1,no AM,NCT: Actual 411 ICTRP: 411 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.jbo.2012.07.002,NA,2006-06-06,NA,2006-05-31,2009-07-31,Interventional,Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer,"A Prospective, Single-arm Multicenter Study to Evaluate Effect of Intravenous Zoledronic Acid on Bone Metabolism Given Over 4 Months in Patients With Prostate Cancer or Breast Cancer and Bone Metastasis",Completed,Phase 4,411,Actual,Novartis,Bone turnover assessed by bone turnover parameters,Pain;Change in prostate specific antigen;Quality of Life;Correlation between pain and bone turnover;Correlation between bone complications and bone turnover,CZOL446EDE28,Effect of Zoledronic Acid on Bone Metabolism in Patients With Bone Metastasis and Prostate or Breast Cancer,"A Prospective, Single-arm Multicenter Study to Evaluate Effect of Intravenous Zoledronic Acid on Bone Metabolism Given Over 4 Months in Patients With Prostate Cancer or Breast Cancer and Bone Metastasis",;;;;,;;;;,Interventional,Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 4,2006-06-02,2006-05-20,411,Completed,Novartis Pharmaceuticals,NULL,germany;germany;germany;germany;germany,Drug: Zoledronic Acid;Drug: Zoledronic Acid;Drug: Zoledronic Acid;Drug: Zoledronic Acid,"
Inclusion criteria:
- Prostate cancer with at least one cancer-related bone lesion with or without hormonal
treatment.
- Breast cancer with at least one cancer-related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential and
Performance status ECOG 0-2
- Normal liver and kidney function
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have
elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or
bone.
Exclusion criteria:
- Prior treatment with bisphosphonates within 6 months before study start, and during
treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other
bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <
8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)
- Current/active dental problems including
- infection of the teeth or jawbone
- dental or fixture trauma
- current or previous osteonecrosis of the jaw
- exposed bone in the mouth
- slow healing after dental procedures
- recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
- Patients with clinically symptomatic brain metastases. Severe physical or
psychological concomitant diseases expected to impair compliance with the provisions
of the study protocol or impair the assessment of drug of patient safety
- Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant
pathologic findings in ECG
- History of diseases with influence on bone metabolism such as Paget´s disease and
primary hyperparathyroidism and with need of treatment for osteoporosis (defined
according to DVO, T-Score =2.5).
- Previous radiation therapy to bone (including therapeutic radioisotopes such as
strontium 89) within 1 month
Additional protocol-defined inclusion/exclusion criteria may apply
;
Inclusion criteria:
- Prostate cancer with at least one cancer-related bone lesion with or without hormonal
treatment.
- Breast cancer with at least one cancer-related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential and
Performance status ECOG 0-2
- Normal liver and kidney function
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have
elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or
bone.
Exclusion criteria:
- Prior treatment with bisphosphonates within 6 months before study start, and during
treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other
bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <
8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)
- Current/active dental problems including
- infection of the teeth or jawbone
- dental or fixture trauma
- current or previous osteonecrosis of the jaw
- exposed bone in the mouth
- slow healing after dental procedures
- recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
- Patients with clinically symptomatic brain metastases. Severe physical or
psychological concomitant diseases expected to impair compliance with the provisions
of the study protocol or impair the assessment of drug of patient safety
- Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant
pathologic findings in ECG
- History of diseases with influence on bone metabolism such as Paget´s disease and
primary hyperparathyroidism and with need of treatment for osteoporosis (defined
according to DVO, T-Score =2.5).
- Previous radiation therapy to bone (including therapeutic radioisotopes such as
strontium 89) within 1 month
Additional protocol-defined inclusion/exclusion criteria may apply
;
Inclusion criteria:
- Prostate cancer with at least one cancer-related bone lesion with or without hormonal
treatment.
- Breast cancer with at least one cancer-related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential and
Performance status ECOG 0-2
- Normal liver and kidney function
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have
elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or
bone.
Exclusion criteria:
- Prior treatment with bisphosphonates within 6 months before study start, and during
treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other
bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <
8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)
- Current/active dental problems including
- infection of the teeth or jawbone
- dental or fixture trauma
- current or previous osteonecrosis of the jaw
- exposed bone in the mouth
- slow healing after dental procedures
- recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
- Patients with clinically symptomatic brain metastases. Severe physical or
psychological concomitant diseases expected to impair compliance with the provisions
of the study protocol or impair the assessment of drug of patient safety
- Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant
pathologic findings in ECG
- History of diseases with influence on bone metabolism such as Paget´s disease and
primary hyperparathyroidism and with need of treatment for osteoporosis (defined
according to DVO, T-Score =2.5).
- Previous radiation therapy to bone (including therapeutic radioisotopes such as
strontium 89) within 1 month
Additional protocol-defined inclusion/exclusion criteria may apply
;
Inclusion criteria:
- Prostate cancer with at least one cancer-related bone lesion with or without hormonal
treatment.
- Breast cancer with at least one cancer-related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential and
Performance status ECOG 0-2
- Normal liver and kidney function
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have
elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or
bone.
Exclusion criteria:
- Prior treatment with bisphosphonates within 6 months before study start, and during
treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other
bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <
8.0 mg/dl (2.00 mmol/L) or =12.0mg/dl (3.00 mmol/L)
- Current/active dental problems including
- infection of the teeth or jawbone
- dental or fixture trauma
- current or previous osteonecrosis of the jaw
- exposed bone in the mouth
- slow healing after dental procedures
- recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
- Patients with clinically symptomatic brain metastases. Severe physical or
psychological concomitant diseases expected to impair compliance with the provisions
of the study protocol or impair the assessment of drug of patient safety
- Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant
pathologic findings in ECG
- History of diseases with influence on bone metabolism such as Paget´s disease and
primary hyperparathyroidism and with need of treatment for osteoporosis (defined
according to DVO, T-Score =2.5).
- Previous radiation therapy to bone (including therapeutic radioisotopes such as
strontium 89) within 1 month
Additional protocol-defined inclusion/exclusion criteria may apply
",NULL,Bone turnover assessed by bone turnover parameters;Bone turnover assessed by bone turnover parameters;Bone turnover assessed by bone turnover parameters,Pain;Change in prostate specific antigen;Quality of Life;Correlation between pain and bone turnover;Correlation between bone complications and bone turnover,NCT00334139; CZOL446EDE28,2012-11-21,no,Prostate Cancer; Breast Cancer; Bone Metastasis; Malignant neoplasm of prostate; Malignant neoplasm of breast,Arm 1 Drug: Zoledronic Acid,Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),IV,- Bone turnover assessed by bone turnover parameters; time frame: every 30 days
,- Pain; time frame: every 30 days
- Change in prostate specific antigen; time frame: every 30 days
- Quality of Life; time frame: every 30 days
- Correlation between pain and bone turnover; time frame: at end of study
- Correlation between bone complications and bone turnover; time frame: end of study
,Germany,[---]* Ulm,2006-06-30,NA,411,NA,"Inclusion criteria:
- Prostate cancer with at least one cancer-related bone lesion with or without hormonal
treatment.
- Breast cancer with at least one cancer-related bone lesion
- Negative pregnancy test at screening in case of child-bearing potential and
Performance status ECOG 0-2
- Normal liver and kidney function
- Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have
elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or
bone.
"," Exclusion criteria:
- Prior treatment with bisphosphonates within 6 months before study start, and during
treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other
bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration <
8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L)
- Current/active dental problems including
- infection of the teeth or jawbone
- dental or fixture trauma
- current or previous osteonecrosis of the jaw
- exposed bone in the mouth
- slow healing after dental procedures
- recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants)
- Patients with clinically symptomatic brain metastases. Severe physical or
psychological concomitant diseases expected to impair compliance with the provisions
of the study protocol or impair the assessment of drug of patient safety
- Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant
pathologic findings in ECG
- History of diseases with influence on bone metabolism such as Paget´s disease and
primary hyperparathyroidism and with need of treatment for osteoporosis (defined
according to DVO, T-Score ≤2.5).
- Previous radiation therapy to bone (including therapeutic radioisotopes such as
strontium 89) within 1 month
Additional protocol-defined inclusion/exclusion criteria may apply
","A Prospective, Single-arm Multicenter Study to Evaluate Effect of Intravenous Zoledronic Acid on Bone Metabolism Given Over 4 Months in Patients With Prostate Cancer or Breast Cancer and Bone Metastasis","Recruiting complete, follow-up complete",Novartis Pharmaceuticals; Novartis Pharmeceuticals; Novartis Pharmeceuticals,[---]*; [---]*; [---]*,Arm 1 Drug: Zoledronic Acid,2006-05-31,2006-06-02,2006-06-02,411,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2006,2017-02-03,TRUE,TRUE,TRUE
18787,NCT00032162,NA,NCT00032162,NCT: 2002-03-08 ICTRP: 2002-03-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,NA,NA,NA,NCT: Actual 63 ICTRP: 63 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2003-01-27,NA,2001-08-31,NA,Interventional,Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer,"Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors",Completed,Phase 1/Phase 2,63,Actual,AGO Study Group,DL DLT,,AGOSG-AGO-GYN-2;EU-20147;CDR0000069262,Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer,"Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors",,,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 1/Phase 2,2002-03-08,2001-08-20,63,Completed,AGO Study Group,NULL,germany,Drug: carboplatin;Drug: pegylated liposomal doxorubicin hydrochloride,"
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed
tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or
cervical cancer
- No ovarian epithelial cancer
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2 OR
- Karnofsky 70-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 10.0 g/dL
Hepatic:
- Bilirubin no greater than 1.25 times upper limit of normal
Renal:
- Glomerular filtration rate at least 60 mL/min
Cardiovascular:
- No atrial or ventricular arrhythmias
- No congestive heart failure even if stabilized on medication
- No New York Heart Association class III or IV heart disease
- No myocardial infarction within the past 6 months
Other:
- No pre-existing sensory or motor neuropathy grade 2 or greater
- No active infection
- No other serious medical condition that would preclude study
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- No more than 1 prior chemotherapy regimen for the malignancy
- No other concurrent chemotherapy
Endocrine therapy:
- Prior hormonal therapy within the past 10 days allowed
- No concurrent hormonal therapy
Radiotherapy:
- At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow
Surgery:
- Not specified
Other:
- At least 30 days since prior experimental agents
- No other concurrent therapies that would preclude study
- No concurrent participation in another study
",NULL,DL DLT,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-08-31,2002-03-08,2002-03-08,63,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2012-05-29,TRUE,FALSE,FALSE
8038,NCT01849874,NA,NCT01849874,NCT: 2013-05-06 ICTRP: 2013-05-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no measure,5,NA,NA,NCT: Anticipated 360 ICTRP: 360 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,Studienprotokoll,10.1200/jco.2014.32.15_suppl.tps5618,NA,2013-05-09,NA,2013-06-28,2021-06-30,Interventional,"A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer","The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum","Active, not recruiting",Phase 3,360,Anticipated,Pfizer,Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival.,"Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of overall survival, objective response rate, duration of response and disease control rate.;Characterize the safety profile of the study drug vs. physician's choice of selected chemotherapies in terms of adverse events and clinical laboratory tests.;Assess the effect on global health status of study drug vs. physician's choice of selected chemotherapies in terms of quality-of-life questionnaires.;Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters.",C4211003;2013-000277-72;ARRAY-162-311,"A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer","The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2013-05-06,2013-06-28,360,"Active, not recruiting",Pfizer,NULL,united states;australia;austria;belgium;canada;china;czechia;denmark;finland;france;germany;hungary;ireland;italy;netherlands;norway;poland;spain;sweden;united kingdom;australia;austria;belgium;canada;china;czechia;denmark;finland;france;germany;hungary;ireland;italy;netherlands;norway;poland;spain;sweden;united kingdom;united states;czech republic;luxembourg,"Drug: MEK162, MEK inhibitor; oral;Drug: Physician's choice chemotherapy","
Key Inclusion Criteria:
- Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum
(invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma),
confirmed histologically and verified by central pathology review.
- Recurrent or persistent measurable disease that has progressed (defined as
radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone
is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy,
surgery) and is not amenable to potentially curative intent surgery, as determined by
the patient's treating physician.
- Must have received at least 1 prior platinum-based chemotherapy regimen but have
received no more than 3 lines of prior chemotherapy regimens, with no limit to the
number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant
and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological
therapy (e.g. bevacizumab) administered as a single agent is considered a prior
systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not
considered its own regimen but should be included with the regimen that it follows.
- Available archival tumor sample (excisional or core biopsy) for confirmation of LGS
carcinoma diagnosis. If adequate archival tumor sample is not available, willingness
to consent to tissue biopsy.
- Suitable for treatment with at least one of the physician's choice chemotherapy
options (liposomal doxorubicin, paclitaxel or topotecan) as determined by the
Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Additional criteria exist.
Key Exclusion Criteria:
- History or current evidence of retinal vein occlusion (RVO) or current risk factors
for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity
or hypercoagulability syndromes).
- Prior therapy with a MEK or BRAF inhibitor.
- History of Gilbert's syndrome.
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Uncontrolled or symptomatic brain metastases that are not stable or require steroids,
are potentially life-threatening or have required radiation within 28 days prior to
first dose of study treatment.
- Concomitant malignancies or previous malignancies with less than a 5-year disease-free
interval at the time of first dose of study treatment; patients with adequately
resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix
or ductal carcinoma in situ may be enrolled irrespective of the time of diagnosis.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B
and/or active hepatitis C.
- Prior randomization into this clinical study.
- Additional criteria exist.
",NULL,Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival.,"Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters.;Assess the effect on global health status of study drug vs. physician's choice of selected chemotherapies in terms of quality-of-life questionnaires.;Characterize the safety profile of the study drug vs. physician's choice of selected chemotherapies in terms of adverse events and clinical laboratory tests.;Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of overall survival, objective response rate, duration of response and disease control rate.",2013-000277-72; NCT01849874; ARRAY-162-311,2015-01-30,no,Low-grade Serous Ovarian Cancer; Low-grade Serous Fallopian Tube Cancer; Low-grade Serous Peritoneal Cancer; Malignant neoplasm of ovary; Malignant neoplasm: Fallopian tube,"Arm 1 Drug: MEK162, MEK inhibitor; oral; Arm 2 Drug: Physician's choice chemotherapy",Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,III,- Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival.; time frame: 3 years
,"- Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of overall survival, objective response rate, duration of response and disease control rate.; time frame: 6 years
- Characterize the safety profile of the study drug vs. physician's choice of selected chemotherapies in terms of adverse events and clinical laboratory tests.; time frame: 3 years
- Assess the effect on global health status of study drug vs. physician's choice of selected chemotherapies in terms of quality-of-life questionnaires.; time frame: 3 years
- Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters.; time frame: 3 years
",United States; Australia; Austria; Belgium; Canada; Czech Republic; Denmark; Finland; France; Germany; Hungary; Ireland; Italy; Luxembourg; Netherlands; Norway; Poland; Spain; Sweden; United Kingdom,[---]* Aachen; [---]* Berlin; [---]* Bonn; [---]* Dresden; [---]* Erlangen; [---]* Essen; [---]* Essen; [---]* Frankfurt; [---]* Freiburg; [---]* Gottingen; [---]* Greifswald; [---]* Hannover; [---]* Heidelberg; [---]* Jena; [---]* Kassel; [---]* Kiel; [---]* Lubeck; [---]* Marburg; [---]* Munich; [---]* Tubingen,2013-06-30,NA,360,NA,"- Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum
(invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma),
confirmed histologically and verified by central pathology review.
- Recurrent or persistent measurable disease that has progressed (defined as
radiological and/or clinical progression; an increase in cancer antigen [CA]-125
alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal
therapy, surgery) and is not amenable to potentially curative intent surgery, as
determined by the patient's treating physician.
- Must have received at least 1 prior platinum-based chemotherapy regimen but have
received no more than 3 lines of prior chemotherapy regimens, with no limit to the
number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant
and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological
therapy (e.g. bevacizumab) administered as a single agent is considered a prior
systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not
considered its own regimen but should be included with the regimen that it follows.
- Available archival tumor sample (excisional or core biopsy) for confirmation of LGS
carcinoma diagnosis. If adequate archival tumor sample is not available, willingness
to consent to tissue biopsy.
- Suitable for treatment with at least one of the physician's choice chemotherapy
options (liposomal doxorubicin, paclitaxel or topotecan) as determined by the
Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Additional criteria exist.
Key ","- History or current evidence of retinal vein occlusion (RVO) or current risk factors
for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of
hyperviscosity or hypercoagulability syndromes).
- Prior therapy with a MEK or BRAF inhibitor.
- History of Gilbert's syndrome.
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Uncontrolled or symptomatic brain metastases that are not stable or require steroids,
are potentially life-threatening or have required radiation within 28 days prior to
first dose of study treatment.
- Concomitant malignancies or previous malignancies with less than a 5-year
disease-free interval at the time of first dose of study treatment; patients with
adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ
of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of
diagnosis.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis
B and/or active hepatitis C.
- Prior randomization into this clinical study.
- Additional criteria exist.
","A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer","Recruiting complete, follow-up continuing",Array BioPharma; 303-381-6604; 303-381-6604,[---]*; [---]*; [---]*,"Arm 1 Drug: MEK162, MEK inhibitor; oral; Arm 2 Drug: Physician's choice chemotherapy",2013-06-28,2013-05-06,2013-05-06,360,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2013,2020-11-10,TRUE,TRUE,TRUE
19435,NCT03732820,NA,NCT03732820,NCT: 2018-09-28 ICTRP: 2018-09-28 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Anticipated 720 ICTRP: 720 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Studienprotokoll,10.1200/JCO.2019.37.7_suppl.TPS340,NA,2018-11-07,NA,2018-10-31,2022-08-17,Interventional,Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer,"A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)","Active, not recruiting",Phase 3,720,Anticipated,AstraZeneca,Radiological progression free survival (rPFS),"Change in Mean Cell Volume (fL);Time to first subsequent anticancer therapy or death (TFST);Time to pain progression (TTPP);Overall survival (OS);Time to opiate use;Time to a Symptomatic Skeletal-Related Event (SSRE);Circulating Tumour Cells (CTC) conversion;Time to second progression or death (PFS2);Brief Pain Inventory-Short Form (BPI-SF);Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P);Homologous Recombination Repair (HRR) gene status;Maximum plasma concentration at steady state [Cmax,ss];Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss];Minimum plasma concentration at steady state [Cmin,ss];Partial area under the concentration-time curve in 0-8 h [AUC0-8]);Maximum plasma concentration at steady state [Cmax,ss];Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss];Minimum plasma concentration at steady state [Cmin,ss];Partial area under the concentration-time curve [AUC0-8]);Number of adverse events;Vital signs-blood pressure;Vital signs-pulse rate;Vital signs-body temperature;ECG;Change in Albumin (g/L);Change in Alkaline phosphatase (U/L);Change in Aspartate aminotransferase (U/L);Change in Amylase (U/L);Change in Alanine aminotransferase (U/L);Change in Total bilirubin (μmol/L);Change in Direct bilirubin;Change in Calcium (mmol/L);Change in Chloride (mmol/L);Change in Creatinine (μmol/L);Change in Gamma glutamyltransferase (U/L);Change in Fasting gucose (mmol/L);Change in Lactate dehydrogenase (U/L);Change in Magnesium (mmol/L);Change in Potassium (mmol/L);Change in Phosphorus ((mmol/L);Change in Sodium (mmol/L);Change in Carbon dioxide (mEq/L );Change in Total protein (g/L);Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L);Change in absolute neutrophil count (/L);Change in absolute lymphocyte count (/L);Change in haemoglobin (g/L);Change in platelet count with differential (/L);Change in total white blood cell count with differential(/L);Change in red blood cell count (/l);Change in Haematocrit (%);Urinalysis:change in blood;Urinalysis: Change in protein;Urinalysis: change in glucose",2018-002011-10;D081SC00001,Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer,"A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)",;,;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2018-09-28,2018-10-31,720,"Active, not recruiting",AstraZeneca,Merck Sharp & Dohme Corp.,"united states;australia;belgium;brazil;canada;chile;china;czechia;france;germany;italy;japan;korea, republic of;netherlands;slovakia;spain;turkey;united kingdom;australia;belgium;brazil;canada;chile;china;czechia;france;germany;italy;japan;korea, republic of;netherlands;slovakia;spain;turkey;united kingdom;united states",Drug: olaparib;Drug: abiraterone acetate,"
Inclusion Criteria:
1. Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent form and in the study
protocol.
2. Provision of signed and dated, written informed consent form prior to any mandatory
study specific procedures, sampling, and analyses.
3. For inclusion in i) the optional exploratory genetic research and ii) the optional
biomarker research, patients must fulfill the following criteria:
- Provision of informed consent for genetic research prior to collection of sample.
- Provision of informed consent for biomarker research prior to collection of
sample.
If a patient declines to participate in the optional exploratory genetic research or
the optional biomarker research, there will be no penalty or loss of benefit to the
patient. The patient will not be excluded from other aspects of the study.
4. Patients must be =18 years of age (or =19 years of age in South Korea) at the time of
signing the informed consent form. For patients enrolled in Japan who are <20 years of
age, written informed consent should be obtained from the patient and from his legally
acceptable representative.
5. Histologically or cytologically confirmed prostate adenocarcinoma.
6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone
scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan.
7. First-line metastatic castration-resistant prostate cancer (mCRPC).
8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral
orchiectomy, with serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0
nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving
androgen deprivation therapy (ADT) at study entry should continue to do so throughout
the study.
9. Candidate for abiraterone therapy with documented evidence of progressive disease.
10. Patients must have normal organ and bone marrow function measured within 28 days prior
to administration of study treatment.
11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no
deterioration over the previous 2 weeks.
12. The participant has, in the opinion of the investigator, a life expectancy of at least
6 months.
13. Prior to randomisation, sites must confirm availability of either an archival formalin
fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the
screening window, which meets the minimum pathology and sample requirements in order
to enable homologous recombination repair (HRR) status subgroup analysis of the
primary endpoint radiographic progression-free survival (rPFS). If there is not
written confirmation of the availability of tumour tissue prior to randomisation, the
patient is not eligible for the study.
14. Male patients must use a condom during treatment and for 3 months after the last dose
of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a
woman of childbearing potential. Female partners of male patients should also use a
highly effective form of contraception if they are of childbearing potential.
Exclusion Criteria:
1. Has a known additional malignancy that has had progression or has required active
treatment in the last 5 years.
2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with
features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).
3. Clinically significant cardiovascular disease Association Class II-IV heart failure or
cardiac ejection fraction measurement of <50% during screening as assessed by
echocardiography or multigated acquisition scan.
4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.
5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery
stenosis).
6. Uncontrolled hypertension (systolic blood pressure (BP) =160 millimeters of mercury
(mmHg) or diastolic blood pressure (BP) =95 millimeters of mercury (mmHg)).
7. History of uncontrolled pituitary or adrenal dysfunction.
8. Active infection or other medical condition that would make prednisone/prednisolone
use contraindicated.
9. Any chronic medical condition requiring a systemic dose of corticosteroid >10
milligrams (mg) prednisone/prednisolone per day.
10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease or active, uncontrolled infection.
11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade
>2) caused by previous cancer therapy, excluding alopecia.
12. Patients with brain metastases. A scan to confirm the absence of brain metastases is
not required.
13. Patients with spinal cord compression are excluded unless they are considered to have
received definitive treatment for this and have evidence of clinically stable disease
for 4 weeks.
14. Patients who are unevaluable for both bone and soft tissue progression
15. Patients who are unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study
medication.
16. Immunocompromised patients
17. Patients with known active hepatitis infection (ie, hepatitis B or C).
18. Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)]
polymerase (PARP) inhibitor, including olaparib.
19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative
reasons) within 3 weeks prior to study treatment. Patients who receive palliative
radiotherapy need to stop radiotherapy 1 week before randomisation.
20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17a-hydroxylase/C17,20-lyase)
inhibitor (eg, abiraterone, orteronel).
21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole,
telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or
cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate
CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil).
The required washout period prior to starting study treatment is 2 weeks.
22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital,
enzalutamide, phenytoin, rifampicin, rifabutin, rifap",NULL,Radiological progression free survival (rPFS),"Time to first subsequent anticancer therapy or death (TFST);Time to pain progression (TTPP);Overall survival (OS);Time to opiate use;Time to a Symptomatic Skeletal-Related Event (SSRE);Circulating Tumour Cells (CTC) conversion;Time to second progression or death (PFS2);Brief Pain Inventory-Short Form (BPI-SF);Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P);Homologous Recombination Repair (HRR) gene status;Maximum plasma concentration at steady state [Cmax,ss];Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss];Minimum plasma concentration at steady state [Cmin,ss];Partial area under the concentration-time curve in 0-8 h [AUC0-8]);Maximum plasma concentration at steady state [Cmax,ss];Time to maximum plasma concentration at steady state (Cmax,ss) [tmax,ss];Minimum plasma concentration at steady state [Cmin,ss];Partial area under the concentration-time curve [AUC0-8]);Number of adverse events;Vital signs-blood pressure;Vital signs-pulse rate;Vital signs-body temperature;ECG;Change in Albumin (g/L);Change in Alkaline phosphatase (U/L);Change in Aspartate aminotransferase (U/L);Change in Amylase (U/L);Change in Alanine aminotransferase (U/L);Change in Total bilirubin (µmol/L);Change in Direct bilirubin;Change in Calcium (mmol/L);Change in Chloride (mmol/L);Change in Creatinine (µmol/L);Change in Gamma glutamyltransferase (U/L);Change in Fasting gucose (mmol/L);Change in Lactate dehydrogenase (U/L);Change in Magnesium (mmol/L);Change in Potassium (mmol/L);Change in Phosphorus ((mmol/L);Change in Sodium (mmol/L);Change in Carbon dioxide (mEq/L );Change in Total protein (g/L);Change in Urea or blood urea nitrogen, depending on the local practice (mmol/L);Change in absolute neutrophil count (/L);Change in absolute lymphocyte count (/L);Change in haemoglobin (g/L);Change in platelet count with differential (/L);Change in total white blood cell count with differential(/L);Change in red blood cell count (/l);Change in Haematocrit (%);Change in Mean Cell Volume (fL);Urinalysis:change in blood;Urinalysis: Change in protein;Urinalysis: change in glucose",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-10-31,2018-09-28,2018-09-28,720,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-07-24,TRUE,FALSE,TRUE
24805,NCT02108392,DRKS00007215,DRKS00007215,NCT: NA ICTRP: 2015-05-08 DRKS: 2015-05-08,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no metric",2,NA,"no AM, no measure, no type of outcome (insufficient for checking)",NCT: NA ICTRP: 100 DRKS: [---]* 100,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2014-04-09,NA,2014-01-31,2018-12-31,Observational,Characterization of Pseudoxanthoma Elasticum,Characterization of Patients With Pseudoxanthoma Elasticum,Unknown status,NA,100,Anticipated,"University Hospital, Bonn",Ocular phenotype,Biomarkers in PXE,pending,Characterization of Pseudoxanthoma Elasticum,Characterization of Patients With Pseudoxanthoma Elasticum,,,Observational,,,2014-04-01,2014-01-20,100,Unknown status,"University Hospital, Bonn",NULL,germany,NULL,
Inclusion Criteria:
- Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing
,NULL,Ocular phenotype,Biomarkers in PXE,NCT02108392; pending,2015-05-08,yes,Pseudoxanthoma Elasticum; Other specified congenital malformations of skin,,Non-interventional,NA,NA,NA,NA,N/A,- Ocular phenotype; time frame: patients will be followed longitudinally with an expected 1-year average interval between visits; Patients are investigated using a multimodal imaging approach and visual function testing.
,- Biomarkers in PXE; time frame: 1 day (first visit); Potential systemic biomarkers are investigated by collecting blood samples of PXE patients
,Germany,[---]* Bonn,2014-01-31,NA,100,NA,Inclusion Criteria:
- Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing
,NA,Characterization of Patients With Pseudoxanthoma Elasticum,Recruiting ongoing,"University Hospital, Bonn; Department of Ophthalmology, University of Bonn; [---]*",[---]*; [---]*; martin.gliem@ukb.uni-bonn.de,,2014-01-31,2014-04-01,2014-04-01,100,Observational,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2014,2018-06-18,TRUE,TRUE,FALSE
17520,NCT00259428,NA,NCT00259428,NCT: 2005-11-25 ICTRP: 2005-11-25 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,4,1,no time frame,5,1,NA,NCT: Actual 615 ICTRP: 615 DRKS: NA,615,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1056/nejmoa054686,NA,2005-11-29,NA,2001-11-30,2003-08-31,Interventional,EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS),EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS),Completed,Phase 3,615,Actual,Sanofi,The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence,"- AF/AFL related symptoms collected at the time of ECG/TTEM recording,;- mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM);- time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.",SR33589B;EFC3153,EURopean Trial In Atrial Fibrillation(AF) or Flutter (AFL) Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS),EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS),,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",Phase 3,2005-11-25,2001-11-20,615,Completed,Sanofi,NULL,belgium;czech republic;denmark;finland;france;germany;hungary;italy;netherlands;poland;spain;united kingdom;belgium;czech republic;denmark;finland;france;germany;hungary;italy;netherlands;poland;spain;united kingdom,Drug: Dronedarone (SR33589);Drug: placebo,"
Inclusion Criteria:
- Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at
the time of randomization and with at least one ECG-documented AF/AFL episode in the
last 3 months.
Exclusion Criteria:
- MAIN CRITERIA (non-exhaustive list, see protocol for details):
Women of childbearing potential without adequate birth control, Pregnant women,
Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which
increase the risk of severe antiarrhythmic drug side effects, Severe associated
conditions.
",NULL,The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence,"- AF/AFL related symptoms collected at the time of ECG/TTEM recording,;- mean ventricular rate during AF/AFL at first recorded AF/AFL recurrence (12-lead ECG or TTEM);- time from presumed study drug near steady state defined as D5 midnight to first documented AF/AFL recurrence as indicated by ECG/TTEM recording.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-11-30,2005-11-25,2005-11-25,615,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2010-02-08,TRUE,FALSE,FALSE
10236,NCT01452893,NA,NCT01452893,NCT: 2011-09-29 ICTRP: 2011-09-29 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 40 ICTRP: 40 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Review,https://dx.doi.org/10.6065%2Fapem.2015.20.4.179,NA,2011-10-17,NA,2011-03-31,2013-12-31,Observational,Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I,Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I,Completed,NA,40,Actual,University of Wuerzburg,difference in cognitive function before and after physical stress,differences in counterregulatory hormonal response to physical stress,CANDI-1,Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I,Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I,;,;,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2011-09-29,2011-03-20,40,Completed,University of Wuerzburg,NULL,germany,Procedure: Spiroergometry,"
Inclusion Criteria:
- Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control
with normal adrenal function and normal glucose regulation
- Age = 18 years
- Ability to comply with the study protocol
- Capability to perform spiroergometry
Exclusion Criteria:
- Any contraindication for performing spiroergometry according to the guidelines of the
German Cardiac Society:
- acute myocardial infarction
- instable angina pectoris
- symptomatic arrhythmia
- severe and symptomatic stenosis of the aortic valve
- decompensated heart failure
- acute pulmonary embolism
- Acute myocarditis
- Acute pericarditis
- Acute aortic dissection
- main coronary artery disease
- valvulopathies
- electrolyte disturbance
- arterial hypertension (systolic blood pressure > 200 mm Hg, diastolic BP > 110
mm Hg)
- Tachyarrhythmia or Bradyarrhythmia
- Hypertrophic cardiomyopathy and other forms of obstructive heart disease
- second or third degree atrioventricular block
- Fever
- Diabetes mellitus Type 2
- Diseases or medication influencing the endogenous levels of plasma catecholamines(e.
g. pheochromocytoma, paraganglioma, antidepressants, levodopa)
- Glucocorticoid-pharmacotherapy
",NULL,difference in cognitive function before and after physical stress,differences in counterregulatory hormonal response to physical stress,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-03-31,2011-09-29,2011-09-29,40,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2011,2014-01-03,TRUE,FALSE,FALSE
10801,NCT01362361,NA,NCT01362361,NCT: 2011-05-25 ICTRP: 2011-05-25 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no measure,NA,NA,NA,NCT: Actual 54 ICTRP: 54 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,Studienprotokoll,10.1200/jco.2012.30.15_suppl.tps3636,NA,2011-05-30,NA,2011-06-30,2016-12-31,Interventional,"TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)","TRICC-C: A Multicenter, Randomized, Phase II Trial: BIBF 1120 vs. Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)",Completed,Phase 2,54,Actual,Martin-Luther-Universität Halle-Wittenberg,progression free survival,,2010-023050-37;TRICC-C (AIO-KRK-0111),"TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)","TRICC-C: A Multicenter, Randomized, Phase II Trial: BIBF 1120 vs. Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)",NULL,NULL,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2011-05-25,2011-06-20,54,Completed,Martin-Luther-Universität Halle-Wittenberg,GALMED GmbH,germany,Drug: mFOLFOX6 + BIBF 1120;Drug: mFOLFOX6+placebo,"
Inclusion Criteria:
1. Histologically proven colorectal adenocarcinoma
2. Intended treatment with mFOLFOX6 after one prior palliative chemotherapy for
metastatic CRC
3. Age > 18 years
4. Metastatic disease not suitable for curative-intent surgery
5. Measurable (> 1 cm) and evaluable disease (according to RECIST 1.1 criteria)
6. Prior bevacizumab, cetuximab or panitumumab are allowed.
7. Previous adjuvant oxaliplatin-containing therapy is allowed, if the end of adjuvant
chemotherapy is >12 months prior to inclusion into the trial
8. ECOG performance status 0 or 1 (see appendix 10.4)
9. Adequate hepatic function
10. Adequate Renal function
11. Adequate bone marrow function
12. Other lab parameters: proteinuria < CTCAE grade 2, Prothrombin time and/or partial
thromboplastin time < 50 % deviation from normal limits
13. Life expectancy at least 3 months
14. Signed and dated written informed consent prior to admission to the study in
accordance with ICH-GCP guidelines and to the local legislation
Exclusion Criteria:
1. Known hypersensitivity to the trial drugs or their excipients.
2. Treatment with any investigational drug within 28 days of trial onset.
3. Prior treatment with more than one line of palliative standard chemotherapy for
colorectal cancer, prior treatment with a tyrosine kinase inhibitor, prior palliative
treatment with an oxaliplatin-containing regime.
4. History of other malignancies in the last 5 years, in particular those which could
affect compliance with the protocol or interpretation of results. Patients with
adequately treated basal or squamous cell skin cancer are generally eligible.
5. Serious concomitant disease, especially those that would limit compliance with trial
requirements or which are considered relevant for the evaluation of the efficacy or
safety of the trial drug, such as neurologic, psychiatric, infectious disease or
active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may
increase the risk associated with trial participation or trial drug administration,
and in the judgment of the investigator would make the patient inappropriate for entry
into the trial.
6. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or
planned surgical procedures during the trial period. Portimplantation prior to therapy
is allowed.
7. Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina,
history of infarction within past 9 months, congestive heart failure > NYHA II) (see
appendix 10.3).
8. History of severe haemorrhagic or thrombotic events in the past 12 months (excluding
central venous catheter thrombosis and peripheral deep vein thrombosis). Known
inherited predisposition to bleeds or to thrombosis.
9. Patient with brain metastases that are symptomatic and/or require therapy.
10. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed
for maintenance of an indwelling intravenous device) or antiplatelet therapy (except
for chronic low-dose therapy with acetylsalicylic acid = 325mg per day)
11. History of major thrombotic or clinically relevant major bleeding event in the past 6
months
12. Current peripheral neuropathy = CTCAE grade 2 except due to trauma
13. Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial,
antifungal) therapy
14. Gastrointestinal disorders or abnormalities that would interfere with absorption of
the study drug
15. Active alcohol or drug abuse.
16. Women and men who are sexually active and unwilling to use a medically acceptable
method of contraception
17. Pregnancy or breast-feeding
18. Leptomeningeal disease
19. Radiographic evidence of cavitary or necrotic tumours
20. Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of
major blood vessels
21. Severe chemotherapy-associated toxicity during or after adjuvant or palliative
first-line chemotherapy like 5-FU-associated cardiac toxicity (coronary spasm) or
persistent oxaliplatin-associated peripheral neuropathy (= CTCAE grade 2) with
paresthesia associated with pain or functional impairment (after adjuvant
oxaliplatin-containing chemotherapy).
",NULL,progression free survival,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-06-30,2011-05-25,2011-05-25,54,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2011,2019-09-18,TRUE,FALSE,TRUE
8697,NCT01720342,NA,NCT01720342,NCT: 2012-10-22 ICTRP: 2012-10-22 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,4,NA,no AM,NA,NA,NA,NCT: Actual 225 ICTRP: 225 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no indication,kein Artikel,NA,NA,2012-11-02,NA,2013-02-28,2018-04-30,Observational,Enable® Aortic Sutureless Bioprosthesis Evaluation,Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study,Completed,NA,225,Actual,Medtronic Cardiovascular,"Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.",,EASE Enable,Enable® Aortic Sutureless Bioprosthesis Evaluation,Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study,,,Observational,,,2012-10-22,2013-02-20,225,Completed,Medtronic Bakken Research Center,NULL,france;germany;italy;netherlands;spain;switzerland;united kingdom;france;germany;italy;netherlands;spain;switzerland;united kingdom,Procedure: Aortic Valve Replacement surgery,"
Inclusion Criteria:
- Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the
two.
- Patient requires replacement of his/her native aortic valve with a bioprosthesis with
or without concomitant procedures.
- Patient is above the minimum age as required by local regulations to be participating
in a clinical study.
- Patient is willing to return to the implant site for follow-up visits.
- Patient has been adequately informed of this clinical study and is willing to sign the
patient Data Release Form.
Exclusion Criteria:
- Patient requires replacement of two or more valves.
- Patient who underwent previous aortic valve replacement (AVR).
- Patient with native bicuspid aortic valve.
- Patient with active endocarditis or other systemic infection.
- Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or
ascending aorta geometry as seen via preoperative imaging.
",NULL,"Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.",NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-02-28,2012-10-22,2012-10-22,225,Observational,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,2019-04-29,TRUE,FALSE,FALSE
6661,NCT02132637,NA,NCT02132637,NCT: 2014-05-05 ICTRP: 2014-05-05 DRKS: NA,1,1,NA,2,1,r,criteria more specific in register,1,1,NA,5,1,NA,5,1,NA,NCT: Actual 68 ICTRP: 68 DRKS: NA,68,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1089/dia.2016.0414,NA,2014-05-07,NA,2014-05-31,2015-07-31,Interventional,A Study to Compare the Effect of a Double Dose of Two Long-acting Insulin Therapies in Participants With Type 2 Diabetes,"A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients With Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study",Completed,Phase 3,68,Actual,Eli Lilly and Company,Percentage of Participants With Clinically Significant Hypoglycemia,Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose;Percentage of Participants With Hypoglycemia;Nadir Glucose;Time to the Nadir Glucose;Duration of Glucose ≤70 mg/dL;Fasting Blood Glucose;Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC);Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion;Beta Cell Function,I2R-MC-BIDD;2012-005174-56;14288,A Study to Compare the Effect of a Double Dose of Two Long-acting Insulin Therapies in Participants With Type 2 Diabetes,"A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients With Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study",,,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2014-05-05,2014-05-20,68,Completed,Eli Lilly and Company,NULL,united states;germany;united states,Drug: Insulin Peglispro;Drug: Insulin Glargine,"
Inclusion Criteria:
- Have type 2 diabetes mellitus (T2DM), based on the World Health Organization (WHO)
classification, for =1 year.
- Use any type of basal insulin (except degludec), including once-or twice-daily human
insulin neutral protamine Hagedom (NPH), insulin detemir, or insulin glargine.
- Have hemoglobin A1c (HbA1c) levels =9.0% according to local laboratory testing at
screening.
- Have body mass index (BMI) =40.0 kilograms/square meter (kg/m^2).
- Have been treated with stable doses of insulin for at least 30 days before screening
with:
- Basal insulin with daily doses ±30% of mean during the last 4 weeks.
- Doses of a basal insulin must be between 0.3 unit/kg/day and 1 unit/kg/day.
- If on metformin, thiazolidinediones (TZDs), sodium glucose co-transporter 2 (SGLT-2)
inhibitors, or dipeptidyl peptidase (DPP4) inhibitors, must be on stable doses for the
last 30 days.
Exclusion Criteria:
- Are using prandial, self-mixed, or premixed insulin. Participants using prandial
insulin may be switched to everyday (qd) glargine if investigator judges that the
participant will still meet fasting glucose requirements for randomization.
- Are using insulin pump therapy.
- Have excessive insulin resistance: Defined as >1.0 unit/kg/day as baseline treatment.
- If being treated with sulfonylureas (SUs) before screening, then must have SUs washed
out between screening and randomization.
- Use any of these concomitant medications: morphine, codeine, antidiuretics,
glucagon-like peptide-1 (GLP-1) receptor agonists (for example, exenatide, exenatide
once weekly, lixisenatide or liraglutide), or pramlintide, used concurrently or within
90 days before screening.
- Have hypoglycemia unawareness, defined as confirmed by laboratory test results or by
historical episodes of hypoglycemia <54 mg/dL (3.0 mmol/L) without symptoms.
- Have fasting hypertriglyceridemia >400 mg/dL (>4.5 mmol/L) at screening, as determined
by the local laboratory.
- Have had any episode of severe hypoglycemia (defined by requiring assistance due to
neurologically disabling hypoglycemia) within 6 months before entry into the study.
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose
control in the past 6 months.
- Have had a previous clinically significant episode of ketoacidosis as determined by
the investigator (ketone bodies at fasting and without acidosis is acceptable) in the
past 6 months.
- Have history of renal transplantation, are currently receiving renal dialysis, or have
estimated Glomerular Filtration Rate (eGFR) <60 milliliters/minute.
- Have obvious clinical signs or symptoms of liver disease (excluding nonalcoholic fatty
liver disease), acute or chronic hepatitis, nonalcoholic steatohepatitis, or elevated
liver enzyme measurements.
- Have active or untreated malignancy, have been in remission from clinically
significant malignancy (other than basal cell or squamous cell skin cancer) for less
than 5 years, or are at increased risk for developing cancer or a recurrence of cancer
in the opinion of the investigator.
",NULL,Percentage of Participants With Clinically Significant Hypoglycemia,Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose;Percentage of Participants With Hypoglycemia;Nadir Glucose;Time to the Nadir Glucose;Duration of Glucose =70 mg/dL;Fasting Blood Glucose;Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC);Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion;Beta Cell Function,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-05-31,2014-05-05,2014-05-05,68,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2014,2019-09-06,TRUE,FALSE,TRUE
12191,NCT01147185,NA,NCT01147185,NCT: 2010-05-07 ICTRP: 2010-05-07 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,4,0,"no AM; not reported, also 6-month-follow-up not reported (mentioned as limitation in the article)",5,0,no AM; not reported due to data sparsity (metioned as limitation in paper),NCT: Actual 21 ICTRP: 21 DRKS: NA,21,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1089/neu.2016.4643,NA,2010-06-22,NA,2010-02-28,2016-06-30,Interventional,Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial,Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial,Completed,N/A,21,Actual,University of Zurich,Ten meter walking test,Walking Index for Spinal Cord Injury (WISCI);Spasticity;Perceived exertion;Spinal Cord Independence Measure;Spinal cord injury classification;Patients' Global Impression of Change Scale,EMSCI-DR;EMSCI-DR,Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial,Effectiveness of Automated Locomotor Training in Patients With Acute Incomplete Spinal Cord Injury: A Multicenter Trial,;,;,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment",N/A,2010-05-07,2010-02-20,21,Completed,University of Zurich,NULL,germany;spain;switzerland;germany;spain;switzerland;germany;spain;switzerland;germany;spain;switzerland,Device: Locomotor training using a robotic device;Device: Locomotor training using a robotic device;Device: Locomotor training using a robotic device;Device: Locomotor training using a robotic device,"
Inclusion Criteria:
- patients with spinal cord injury (SCI) categorized according to the standard
classification of the American Spinal Injury Association as ASIA B or C within the
first two weeks after trauma
- traumatic etiology of SCI
- limited walking ability (Walking Index for Spinal Cord Injury =5)
- able to start training or rehab within 60 days after trauma
- motor level between cervical 4 and thoracic 12
- signed informed consent
Exclusion Criteria:
- exclusion criteria of the Lokomat:(bodyweight > 130kg, body height > 200cm, leg
length diff > 2cm, osteoporosis, instable fracture of lower extremity, restricted
range of motion, decubitus ulcer of lower extremity)
- concomitant injury limiting walking ability (e.g. lower extremity fractures, instable
spine fractures, Joint instability preventing weight-bearing, severe soft tissue
lesion)
- pre-existing medical conditions interfering with unrestricted walking (e.g. total
joint replacement, pain, osteoarthritis, polyneuropathy, cardiopulmonary disease)
- age older than 65 years or younger than 18 years
- conus medullaris or cauda equina syndrome
- traumatic brain injury
- passive range of motion of the hips, knees and ankles not sufficient to allow normal
kinematics consistent with upright gait
- patient participates in other rehabilitation or pharmacological study
;
Inclusion Criteria:
- patients with spinal cord injury (SCI) categorized according to the standard
classification of the American Spinal Injury Association as ASIA B or C within the
first two weeks after trauma
- traumatic etiology of SCI
- limited walking ability (Walking Index for Spinal Cord Injury =5)
- able to start training or rehab within 60 days after trauma
- motor level between cervical 4 and thoracic 12
- signed informed consent
Exclusion Criteria:
- exclusion criteria of the Lokomat:(bodyweight > 130kg, body height > 200cm, leg
length diff > 2cm, osteoporosis, instable fracture of lower extremity, restricted
range of motion, decubitus ulcer of lower extremity)
- concomitant injury limiting walking ability (e.g. lower extremity fractures, instable
spine fractures, Joint instability preventing weight-bearing, severe soft tissue
lesion)
- pre-existing medical conditions interfering with unrestricted walking (e.g. total
joint replacement, pain, osteoarthritis, polyneuropathy, cardiopulmonary disease)
- age older than 65 years or younger than 18 years
- conus medullaris or cauda equina syndrome
- traumatic brain injury
- passive range of motion of the hips, knees and ankles not sufficient to allow normal
kinematics consistent with upright gait
- patient participates in other rehabilitation or pharmacological study
",NULL,Ten meter walking test;Ten meter walking test,Patients' Global Impression of Change Scale;Spinal cord injury classification;Spinal Cord Independence Measure;Perceived exertion;Spasticity;Walking Index for Spinal Cord Injury (WISCI);Patients' Global Impression of Change Scale;Spinal cord injury classification;Spinal Cord Independence Measure;Perceived exertion;Spasticity;Walking Index for Spinal Cord Injury (WISCI),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-02-28,2010-05-07,2010-05-07,21,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2010,2016-06-28,TRUE,FALSE,FALSE
15403,NCT00597584,NA,NA,NCT: 2008-01-10 ICTRP: NA DRKS: NA,1,1,NA,1,1,NA,NA,2,1,NA,5,1,no AM,5,1,NA,NCT: Actual 823 ICTRP: NA DRKS: NA,823,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1056/nejmoa1203165,NA,2008-01-18,NA,2007-10-31,2010-01-31,Interventional,Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis,"AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin",Completed,Phase 3,823,Actual,Affymax,Mean Change in Hemoglobin Between Baseline and the Evaluation Period,Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods;Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL),2007-004153-28;AFX01-14,Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis,"AFX01-14: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Maintenance Treatment of Anemia in Hemodialysis Patients Previously Treated With Epoetin",;;;,;;;,Interventional,,Phase 3,2008-01-10,2007-10-20,823,Completed,Affymax,Takeda,united states;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;united states;united states;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;united states;united states;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;united states;united states;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;bulgaria;france;germany;italy;poland;romania;spain;united kingdom;united states,Drug: peginesatide;Drug: Epoetin alfa or Epoetin beta;Drug: peginesatide;Drug: Epoetin alfa or Epoetin beta;Drug: peginesatide;Drug: Epoetin alfa or Epoetin beta;Drug: peginesatide;Drug: Epoetin alfa or Epoetin beta,
Inclusion Criteria
1. Participants with chronic renal failure on hemodialysis for = 3 months prior to
randomization.
2. On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum
of 8 weeks prior to randomization.
3. Four consecutive hemoglobin values with a mean = 10.0 and = 12.0 g/dL during the
Screening Period.
Exclusion Criteria
1. Females who are pregnant or breast-feeding.
2. Known intolerance to any erythropoiesis stimulating agent or pegylated molecule or to
all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause of anemia other than renal disease
5. Poorly controlled hypertension.
6. Evidence of active malignancy within one year prior to randomization.
7. Temporary (untunneled) dialysis access catheter.
8. A scheduled kidney transplant.
9. A scheduled surgery that may be expected to lead to significant blood loss.
;
Inclusion Criteria
1. Participants with chronic renal failure on hemodialysis for = 3 months prior to
randomization.
2. On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum
of 8 weeks prior to randomization.
3. Four consecutive hemoglobin values with a mean = 10.0 and = 12.0 g/dL during the
Screening Period.
Exclusion Criteria
1. Females who are pregnant or breast-feeding.
2. Known intolerance to any erythropoiesis stimulating agent or pegylated molecule or to
all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause of anemia other than renal disease
5. Poorly controlled hypertension.
6. Evidence of active malignancy within one year prior to randomization.
7. Temporary (untunneled) dialysis access catheter.
8. A scheduled kidney transplant.
9. A scheduled surgery that may be expected to lead to significant blood loss.
;
Inclusion Criteria
1. Participants with chronic renal failure on hemodialysis for = 3 months prior to
randomization.
2. On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum
of 8 weeks prior to randomization.
3. Four consecutive hemoglobin values with a mean = 10.0 and = 12.0 g/dL during the
Screening Period.
Exclusion Criteria
1. Females who are pregnant or breast-feeding.
2. Known intolerance to any erythropoiesis stimulating agent or pegylated molecule or to
all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause of anemia other than renal disease
5. Poorly controlled hypertension.
6. Evidence of active malignancy within one year prior to randomization.
7. Temporary (untunneled) dialysis access catheter.
8. A scheduled kidney transplant.
9. A scheduled surgery that may be expected to lead to significant blood loss.
;
Inclusion Criteria
1. Participants with chronic renal failure on hemodialysis for = 3 months prior to
randomization.
2. On IV epoetin alfa or beta maintenance therapy continuously prescribed for a minimum
of 8 weeks prior to randomization.
3. Four consecutive hemoglobin values with a mean = 10.0 and = 12.0 g/dL during the
Screening Period.
Exclusion Criteria
1. Females who are pregnant or breast-feeding.
2. Known intolerance to any erythropoiesis stimulating agent or pegylated molecule or to
all parenteral iron supplementation products.
3. Known bleeding or coagulation disorder.
4. Known hematologic disease or cause of anemia other than renal disease
5. Poorly controlled hypertension.
6. Evidence of active malignancy within one year prior to randomization.
7. Temporary (untunneled) dialysis access catheter.
8. A scheduled kidney transplant.
9. A scheduled surgery that may be expected to lead to significant blood loss.
,NULL,Mean Change in Hemoglobin Between Baseline and the Evaluation Period;Mean Change in Hemoglobin Between Baseline and the Evaluation Period,Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods;Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-10-31,2008-01-10,2008-01-10,823,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2007,2013-03-06,TRUE,FALSE,TRUE
25359,NCT02021409,DRKS00006416,DRKS00006416,NCT: NA ICTRP: 2014-11-03 DRKS: 2014-11-03,1,1,NA,2,0,NA,Mean Hb lower value 9 in article instead of 10,1,1,NA,4,1,no AM,5,1,NA,NCT: NA ICTRP: 120 DRKS: [---]* 120,124,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.2215/CJN.02510218,NA,2013-12-27,NA,2014-01-28,2015-11-23,Interventional,Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934,"A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific",Completed,Phase 2,126,Actual,Bayer,Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period,Maintenance in hemoglobin target range (10.0 to 12.0 g/dL);Change in hemoglobin level;Number of patients with hemoglobin levels outside the target range;Dose level in the evaluation period;Duration of exposure on each dose level;Number of subjects requiring titration of dose;Number of participants with serious adverse events as a measure of safety and tolerability,2013-001192-21;15261,Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment Versus BAY85-3934,"A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2013-12-20,2014-01-28,126,Completed,Bayer,NULL,"australia;bulgaria;france;germany;hungary;israel;italy;japan;korea, republic of;poland;romania;spain;turkey;united kingdom;australia;bulgaria;france;germany;hungary;israel;italy;japan;korea, republic of;poland;romania;spain;turkey;united kingdom",Drug: BAY85-3934;Biological: Darbepoetin alfa,"
Inclusion Criteria:
- Male or female subjects = 18 years of age with anemia of chronic kidney disease (CKD)
at screening
- Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of
Diet in Renal Disease or the formula according to Matsuo, et al.)
- Not on dialysis and not expected to begin dialysis during the treatment period of the
study (at least 16 weeks from randomization)
- Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a
weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8
weeks prior to randomization
- At least one kidney
- Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL
- Men who agree to use adequate contraception when sexually active or women without
childbearing potential
Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal
bleeding
- Active hemolysis or diagnosis of hemolytic syndrome
- History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure
red-cell aplasia (PRCA)
- History of hemosiderosis or hemochromatosis
- Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)
- Aplastic anemia
- Chronic lymphoproliferative diseases
- Proliferative choroidal or retinal disease, such as neovascular age-related macular
degeneration or proliferative diabetic retinopathy that is likely to require invasive
treatment (intraocular injections or laser photocoagulation) during the study
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus
erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
remission
- Known hypersensitivity to the study drugs (active substances or excipients of the
preparations)
- Uncontrolled and symptomatic hyperparathyroidism
- Uncontrolled active infection
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell
carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively
treated > 3 years prior to randomization
- Any allograft (including renal allograft) in place and on immunosuppressive therapy or
a scheduled kidney transplant within the next 16 weeks (being on a waiting list does
not exclude the subject)
",NULL,Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period,Maintenance in hemoglobin target range (10.0 to 12.0 g/dL);Change in hemoglobin level;Number of patients with hemoglobin levels outside the target range;Dose level in the evaluation period;Duration of exposure on each dose level;Number of subjects requiring titration of dose;Number of participants with serious adverse events as a measure of safety and tolerability,2013-001192-21; NCT02021409; 15261; 2013-001192-21,2014-11-03,no,"Anemia; Renal Insufficiency, Chronic; Anaemia, unspecified; Chronic kidney disease",Arm 1 Drug: BAY85-3934; Arm 2 Biological: Darbepoetin alfa,Interventional,Randomized controlled trial,Open (masking not used),Active control,Parallel,II,- Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period; time frame: Baseline and week 12 to 16
,- Maintenance in hemoglobin target range (10.0 to 12.0 g/dL); time frame: Up to 16 weeks
- Change in hemoglobin level; time frame: Baseline up to 16 weeks
- Number of patients with hemoglobin levels outside the target range; time frame: Week 12 to 16
- Dose level in the evaluation period; time frame: Week 12 to 16
- Duration of exposure on each dose level; time frame: Up to 16 weeks
- Number of subjects requiring titration of dose; time frame: Up to 16 weeks
- Number of participants with serious adverse events as a measure of safety and tolerability; time frame: Up to 16 weeks
,"Australia; Bulgaria; France; Germany; Hungary; Italy; Japan; Korea, Republic of; Poland; Romania; Spain; United Kingdom",[---]* Bonn; [---]* Düsseldorf; [---]* Halle (Saale); [---]* Berlin; [---]* Wuppertal,2014-01-31,NA,120,NA,"- Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD)
at screening
- Estimated glomerular filtration rate (eGFR) of < 60 mL/min/1.73 m2 (Modification of
Diet in Renal Disease or the formula according to Matsuo, et al.)
- Not on dialysis and not expected to begin dialysis during the treatment period of the
study (at least 16 weeks from randomization)
- Treated with darbepoetin via intravenous (IV) or subcutaneous (SC) route with a
weekly, bi-weekly, or monthly dose, having had no more than one dose change within 8
weeks prior to randomization
- At least one kidney
- Mean screening hemoglobin (Hb) concentration of 10.0 to 12.0 g/dL
- Men who agree to use adequate contraception when sexually active or women without
childbearing potential
","- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal
bleeding
- Active hemolysis or diagnosis of hemolytic syndrome
- History of myelodysplastic syndrome, multiple myeloma, marrow fibrosis, or pure
red-cell aplasia (PRCA)
- History of hemosiderosis or hemochromatosis
- Hereditary hemoglobinopathies (such as sickle cell disease and thalassemia major)
- Aplastic anemia
- Chronic lymphoproliferative diseases
- Proliferative choroidal or retinal disease, such as neovascular age-related macular
degeneration or proliferative diabetic retinopathy that is likely to require invasive
treatment (intraocular injections or laser photocoagulation) during the study
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus
erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
remission
- Known hypersensitivity to the study drugs (active substances or excipients of the
preparations)
- Uncontrolled and symptomatic hyperparathyroidism
- Uncontrolled active infection
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell
carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively
treated > 3 years prior to randomization
- Any allograft (including renal allograft) in place and on immunosuppressive therapy
or a scheduled kidney transplant within the next 16 weeks (being on a waiting list
does not exclude the subject)
","A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific",Recruiting ongoing,Bayer; Bayer; [---]*,[---]*; [---]*; clinical-trials-contact@bayerhealthcare.com,Arm 1 Drug: BAY85-3934; Arm 2 Biological: Darbepoetin alfa,2014-01-28,2013-12-20,2013-12-20,126,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2014,2019-09-17,TRUE,TRUE,TRUE
8253,NCT01806298,NA,NA,NCT: 2013-03-05 ICTRP: NA DRKS: NA,1,1,NA,2,0,NA,"BMI cutoff 40 in article, 35 in register",1,1,NA,5,1,NA,5,1,NA,NCT: Actual 78 ICTRP: NA DRKS: NA,78,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1007/s40618-017-0818-4,NA,2013-03-07,NA,2013-06-30,2016-03-31,Interventional,An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD),"Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)",Completed,Phase 4,78,Actual,"Merck KGaA, Darmstadt, Germany",Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®,Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs);Insulin-like Growth Factor-I (IGF-I) Levels;Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels;Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS);Treatment Adherence Rate as Documented Using EasypodTM Connect,2012-004263-47;EMR 200104-011,An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD),"Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)",;;;;,;;;;,Interventional,Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 4,2013-03-05,2013-06-20,78,Completed,Merck KGaA,NULL,australia;germany;sweden;united kingdom;australia;germany;sweden;united kingdom;czech republic;australia;germany;sweden;united kingdom;australia;germany;sweden;united kingdom;czech republic;australia;germany;sweden;united kingdom;australia;germany;sweden;united kingdom;czech republic;australia;germany;sweden;united kingdom;australia;germany;sweden;united kingdom;czech republic;australia;germany;sweden;united kingdom;australia;germany;sweden;united kingdom;czech republic,Drug: Saizen® solution for injection (referred as Saizen®);Drug: Saizen® solution for injection (referred as Saizen®);Drug: Saizen® solution for injection (referred as Saizen®);Drug: Saizen® solution for injection (referred as Saizen®),"
Inclusion Criteria:
- Male and female subjects, 18-65 years of age, inclusive, at the time of signature of
informed consent
- Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation
test as described in the GH Research Society's 2007 guidelines for the diagnosis and
treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by
confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1
level below the reference range of the laboratory where testing is performed.
Stimulation test as described in the 2007 GH Research Society guidelines and
applicable to all subjects who underwent or will undergo a stimulation test:
- Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3
nanogram per milliliter (ng/mL);
- GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass
index (BMI):
- BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less
than 11 ng/mL microgram per liter [mcg/L]).
- BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).
- BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).
Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for
determining eligibility in this trial. Stimulation tests remain under the Investigator's or
the subject's physician's responsibility, including the selection of the GH assay. Saizen®
label: in Europe, only one single test is required; in Australia, 2 stimulation tests
showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen
based on the approved label for Saizen® in the countries where the trial is being
implemented, as well as in respect of the most current international guidelines for AGHD.
There is no limit in time prior to the Screening visit for the stimulation test(s), as long
as documentation is available and the stimulation tests comply with the GH Research Society
2007 guidelines, and as such, there is no need to repeat the test for subjects having
stopped their GH therapy prior to the Screening visit. No stimulation test is required for
subjects with 3 or more pituitary hormone deficiencies
- GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to
Screening visit. Whereas any prior use of GH is permitted, providing an adequate
wash-out period is respected to secure the interpretation of the biomarkers, the
reason for stopping the GH therapy should neither be safety- nor efficacy-related, and
documentation should be present in the source information
- Negative BAbs from the Screening visit sample
- Body mass index (BMI, Weight in kilograms / Height in square meters) measured at
Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)
- Negative serum pregnancy test at the Screening for women of childbearing potential and
subject is not lactating
- Understanding and willingness of the subject to comply with the procedures of the
study
- Informed Consent form signed prior to the performance of any trial-related activities
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the Saizen® excipients
- Evidence of growing intracranial tumor including pituitary tumor, or affecting the
optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior
to and the 12 months after the Screening visit
- Presence of active malignancy, neoplasia or any evidence of progression or recurrence
of an underlying tumor. In case of a history of neoplasia or any pre-existing
malignancy, the tumor must be inactive and anti-tumor therapy completed prior to
starting trial on active Saizen® therapy.
- Proliferative or pre-proliferative diabetic retinopathy
- Evidence of chronic underlying disease within 6 months prior to the Screening visit or
concomitant medication that would interfere with subject compliance, the evaluation of
trial results, or compromise the safety of the subject
- Severe hepatic or renal failure that could compromise the interpretation of IGF-1,
that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *
upper limit of the normal range; Glomerular filtration rate (GFR) less than 30
milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory
according to the Modification of Diet in Renal Disease (MDRD) equation
- History of anti-GH antibodies
- History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic
Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene
defect
- Absence of effective contraception in place at the Screening visit in women of
childbearing potential. Acceptable forms of effective contraception include:
established use of oral (greater than 2 months), injected, or implanted hormonal
methods of contraception, intrauterine devices (IUD), or barrier methods of
contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/suppository
- Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)
standard diabetes symptoms and a random glucose greater than or equal to 200 milligram
per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma
glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater
than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);
or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent
- Concomitant or prior participation in an interventional trial within 30 days prior to
the Screening visit
- Known alcohol or drug addiction/dependency
- Has a legal incapacity or limited legal capacity
- Has received anabolic steroids (except for gonadal steroid replacement therapy) or
systemic corticosteroids (except for replacement doses) within 3 months prior to the
Screening visit
- Has received substitutive therapy with glucocorticosteroids, thyroid replacement,
vasopressin, or sex hormones for less than 3 months or substitutive therapy has not
been stable (that is, dose was not generally constant or medical condition was not
controlled) for 3 months prior to Screening
;
Inclusion Criteria:
- Male and female subjects, 18-65 years of age, inclusive, at the time of signature of
informed consent
- Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation
test as described in the GH Research Society's 2007 guidelines for the diagnosis and
treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by
confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1
level below the reference range of the laboratory where testing is performed.
Stimulation test as described in the 2007 GH Research Society guidelines and
applicable to all subjects who underwent or will undergo a stimulation test:
- Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3
nanogram per milliliter (ng/mL);
- GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass
index (BMI):
- BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less
than 11 ng/mL microgram per liter [mcg/L]).
- BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).
- BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).
Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for
determining eligibility in this trial. Stimulation tests remain under the Investigator's or
the subject's physician's responsibility, including the selection of the GH assay. Saizen®
label: in Europe, only one single test is required; in Australia, 2 stimulation tests
showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen
based on the approved label for Saizen® in the countries where the trial is being
implemented, as well as in respect of the most current international guidelines for AGHD.
There is no limit in time prior to the Screening visit for the stimulation test(s), as long
as documentation is available and the stimulation tests comply with the GH Research Society
2007 guidelines, and as such, there is no need to repeat the test for subjects having
stopped their GH therapy prior to the Screening visit. No stimulation test is required for
subjects with 3 or more pituitary hormone deficiencies
- GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to
Screening visit. Whereas any prior use of GH is permitted, providing an adequate
wash-out period is respected to secure the interpretation of the biomarkers, the
reason for stopping the GH therapy should neither be safety- nor efficacy-related, and
documentation should be present in the source information
- Negative BAbs from the Screening visit sample
- Body mass index (BMI, Weight in kilograms / Height in square meters) measured at
Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)
- Negative serum pregnancy test at the Screening for women of childbearing potential and
subject is not lactating
- Understanding and willingness of the subject to comply with the procedures of the
study
- Informed Consent form signed prior to the performance of any trial-related activities
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the Saizen® excipients
- Evidence of growing intracranial tumor including pituitary tumor, or affecting the
optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior
to and the 12 months after the Screening visit
- Presence of active malignancy, neoplasia or any evidence of progression or recurrence
of an underlying tumor. In case of a history of neoplasia or any pre-existing
malignancy, the tumor must be inactive and anti-tumor therapy completed prior to
starting trial on active Saizen® therapy.
- Proliferative or pre-proliferative diabetic retinopathy
- Evidence of chronic underlying disease within 6 months prior to the Screening visit or
concomitant medication that would interfere with subject compliance, the evaluation of
trial results, or compromise the safety of the subject
- Severe hepatic or renal failure that could compromise the interpretation of IGF-1,
that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *
upper limit of the normal range; Glomerular filtration rate (GFR) less than 30
milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory
according to the Modification of Diet in Renal Disease (MDRD) equation
- History of anti-GH antibodies
- History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic
Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene
defect
- Absence of effective contraception in place at the Screening visit in women of
childbearing potential. Acceptable forms of effective contraception include:
established use of oral (greater than 2 months), injected, or implanted hormonal
methods of contraception, intrauterine devices (IUD), or barrier methods of
contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/suppository
- Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)
standard diabetes symptoms and a random glucose greater than or equal to 200 milligram
per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma
glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater
than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);
or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent
- Concomitant or prior participation in an interventional trial within 30 days prior to
the Screening visit
- Known alcohol or drug addiction/dependency
- Has a legal incapacity or limited legal capacity
- Has received anabolic steroids (except for gonadal steroid replacement therapy) or
systemic corticosteroids (except for replacement doses) within 3 months prior to the
Screening visit
- Has received substitutive therapy with glucocorticosteroids, thyroid replacement,
vasopressin, or sex hormones for less than 3 months or substitutive therapy has not
been stable (that is, dose was not generally constant or medical condition was not
controlled) for 3 months prior to Screening
;
Inclusion Criteria:
- Male and female subjects, 18-65 years of age, inclusive, at the time of signature of
informed consent
- Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation
test as described in the GH Research Society's 2007 guidelines for the diagnosis and
treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by
confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1
level below the reference range of the laboratory where testing is performed.
Stimulation test as described in the 2007 GH Research Society guidelines and
applicable to all subjects who underwent or will undergo a stimulation test:
- Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3
nanogram per milliliter (ng/mL);
- GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass
index (BMI):
- BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less
than 11 ng/mL microgram per liter [mcg/L]).
- BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).
- BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).
Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for
determining eligibility in this trial. Stimulation tests remain under the Investigator's or
the subject's physician's responsibility, including the selection of the GH assay. Saizen®
label: in Europe, only one single test is required; in Australia, 2 stimulation tests
showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen
based on the approved label for Saizen® in the countries where the trial is being
implemented, as well as in respect of the most current international guidelines for AGHD.
There is no limit in time prior to the Screening visit for the stimulation test(s), as long
as documentation is available and the stimulation tests comply with the GH Research Society
2007 guidelines, and as such, there is no need to repeat the test for subjects having
stopped their GH therapy prior to the Screening visit. No stimulation test is required for
subjects with 3 or more pituitary hormone deficiencies
- GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to
Screening visit. Whereas any prior use of GH is permitted, providing an adequate
wash-out period is respected to secure the interpretation of the biomarkers, the
reason for stopping the GH therapy should neither be safety- nor efficacy-related, and
documentation should be present in the source information
- Negative BAbs from the Screening visit sample
- Body mass index (BMI, Weight in kilograms / Height in square meters) measured at
Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)
- Negative serum pregnancy test at the Screening for women of childbearing potential and
subject is not lactating
- Understanding and willingness of the subject to comply with the procedures of the
study
- Informed Consent form signed prior to the performance of any trial-related activities
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the Saizen® excipients
- Evidence of growing intracranial tumor including pituitary tumor, or affecting the
optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior
to and the 12 months after the Screening visit
- Presence of active malignancy, neoplasia or any evidence of progression or recurrence
of an underlying tumor. In case of a history of neoplasia or any pre-existing
malignancy, the tumor must be inactive and anti-tumor therapy completed prior to
starting trial on active Saizen® therapy.
- Proliferative or pre-proliferative diabetic retinopathy
- Evidence of chronic underlying disease within 6 months prior to the Screening visit or
concomitant medication that would interfere with subject compliance, the evaluation of
trial results, or compromise the safety of the subject
- Severe hepatic or renal failure that could compromise the interpretation of IGF-1,
that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *
upper limit of the normal range; Glomerular filtration rate (GFR) less than 30
milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory
according to the Modification of Diet in Renal Disease (MDRD) equation
- History of anti-GH antibodies
- History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic
Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene
defect
- Absence of effective contraception in place at the Screening visit in women of
childbearing potential. Acceptable forms of effective contraception include:
established use of oral (greater than 2 months), injected, or implanted hormonal
methods of contraception, intrauterine devices (IUD), or barrier methods of
contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/suppository
- Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)
standard diabetes symptoms and a random glucose greater than or equal to 200 milligram
per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma
glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater
than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);
or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent
- Concomitant or prior participation in an interventional trial within 30 days prior to
the Screening visit
- Known alcohol or drug addiction/dependency
- Has a legal incapacity or limited legal capacity
- Has received anabolic steroids (except for gonadal steroid replacement therapy) or
systemic corticosteroids (except for replacement doses) within 3 months prior to the
Screening visit
- Has received substitutive therapy with glucocorticosteroids, thyroid replacement,
vasopressin, or sex hormones for less than 3 months or substitutive therapy has not
been stable (that is, dose was not generally constant or medical condition was not
controlled) for 3 months prior to Screening
;
Inclusion Criteria:
- Male and female subjects, 18-65 years of age, inclusive, at the time of signature of
informed consent
- Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation
test as described in the GH Research Society's 2007 guidelines for the diagnosis and
treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by
confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1
level below the reference range of the laboratory where testing is performed.
Stimulation test as described in the 2007 GH Research Society guidelines and
applicable to all subjects who underwent or will undergo a stimulation test:
- Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3
nanogram per milliliter (ng/mL);
- GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass
index (BMI):
- BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less
than 11 ng/mL microgram per liter [mcg/L]).
- BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).
- BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).
Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for
determining eligibility in this trial. Stimulation tests remain under the Investigator's or
the subject's physician's responsibility, including the selection of the GH assay. Saizen®
label: in Europe, only one single test is required; in Australia, 2 stimulation tests
showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen
based on the approved label for Saizen® in the countries where the trial is being
implemented, as well as in respect of the most current international guidelines for AGHD.
There is no limit in time prior to the Screening visit for the stimulation test(s), as long
as documentation is available and the stimulation tests comply with the GH Research Society
2007 guidelines, and as such, there is no need to repeat the test for subjects having
stopped their GH therapy prior to the Screening visit. No stimulation test is required for
subjects with 3 or more pituitary hormone deficiencies
- GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to
Screening visit. Whereas any prior use of GH is permitted, providing an adequate
wash-out period is respected to secure the interpretation of the biomarkers, the
reason for stopping the GH therapy should neither be safety- nor efficacy-related, and
documentation should be present in the source information
- Negative BAbs from the Screening visit sample
- Body mass index (BMI, Weight in kilograms / Height in square meters) measured at
Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)
- Negative serum pregnancy test at the Screening for women of childbearing potential and
subject is not lactating
- Understanding and willingness of the subject to comply with the procedures of the
study
- Informed Consent form signed prior to the performance of any trial-related activities
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the Saizen® excipients
- Evidence of growing intracranial tumor including pituitary tumor, or affecting the
optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior
to and the 12 months after the Screening visit
- Presence of active malignancy, neoplasia or any evidence of progression or recurrence
of an underlying tumor. In case of a history of neoplasia or any pre-existing
malignancy, the tumor must be inactive and anti-tumor therapy completed prior to
starting trial on active Saizen® therapy.
- Proliferative or pre-proliferative diabetic retinopathy
- Evidence of chronic underlying disease within 6 months prior to the Screening visit or
concomitant medication that would interfere with subject compliance, the evaluation of
trial results, or compromise the safety of the subject
- Severe hepatic or renal failure that could compromise the interpretation of IGF-1,
that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *
upper limit of the normal range; Glomerular filtration rate (GFR) less than 30
milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory
according to the Modification of Diet in Renal Disease (MDRD) equation
- History of anti-GH antibodies
- History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic
Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene
defect
- Absence of effective contraception in place at the Screening visit in women of
childbearing potential. Acceptable forms of effective contraception include:
established use of oral (greater than 2 months), injected, or implanted hormonal
methods of contraception, intrauterine devices (IUD), or barrier methods of
contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/suppository
- Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)
standard diabetes symptoms and a random glucose greater than or equal to 200 milligram
per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma
glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater
than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);
or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent
- Concomitant or prior participation in an interventional trial within 30 days prior to
the Screening visit
- Known alcohol or drug addiction/dependency
- Has a legal incapacity or limited legal capacity
- Has received anabolic steroids (except for gonadal steroid replacement therapy) or
systemic corticosteroids (except for replacement doses) within 3 months prior to the
Screening visit
- Has received substitutive therapy with glucocorticosteroids, thyroid replacement,
vasopressin, or sex hormones for less than 3 months or substitutive therapy has not
been stable (that is, dose was not generally constant or medical condition was not
controlled) for 3 months prior to Screening
",NULL,Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®;Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®;Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®,Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs);Insulin-like Growth Factor-I (IGF-I) Levels;Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels;Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS);Treatment Adherence Rate as Documented Using EasypodTM Connect,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-06-30,2013-03-05,2013-03-05,78,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,2017-10-25,TRUE,FALSE,TRUE
35016,NCT02946463,NA,EUCTR2016-002025-11,NCT: NA ICTRP: 2016-10-07 DRKS: NA,1,1,NA,2,1,NA,NA,2,0,"extension period for therapy 5 years in register, 2 years in article",5,1,NA,4,1,no AM,NCT: NA ICTRP: 214 DRKS: NA,246,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,ganzer Artikel,https://doi.org/10.1182/blood-2018-09-876136,NA,2016-10-27,NA,2016-12-20,2023-01-31,Interventional,ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH),"A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","Active, not recruiting",Phase 3,246,Actual,Alexion Pharmaceuticals,Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels;Percentage Of Participants Who Achieved Transfusion Avoidance (TA),Percentage Of Participants With Breakthrough Hemolysis (BTH);Percent Change From Baseline In Lactate Dehydrogenase (LDH) Levels;Change From Baseline In Quality Of Life As Assessed By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue;Percentage Of Participants With Stabilized Hemoglobin Levels,2016-002025-11;ALXN1210-PNH-301,ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH),"A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)",NULL,NULL,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2016-10-25,2016-12-20,246,"Active, not recruiting",Alexion Pharmaceuticals,NULL,"united states;argentina;australia;austria;belgium;brazil;canada;czechia;estonia;france;germany;italy;japan;korea, republic of;malaysia;mexico;poland;russian federation;singapore;spain;sweden;taiwan;thailand;turkey;united kingdom;argentina;australia;austria;belgium;brazil;canada;czechia;estonia;france;germany;italy;japan;korea, republic of;malaysia;mexico;poland;russian federation;singapore;spain;sweden;taiwan;thailand;turkey;united kingdom;united states;colombia",Biological: Ravulizumab;Biological: Eculizumab,"
Inclusion Criteria:
1. Male or female =18 years of age.
2. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.
3. Presence of 1 or more of the following PNH-related signs or symptoms within 3 months
of screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea),
anemia (hemoglobin <10 gram/deciliter), history of a major adverse vascular event
(including thrombosis), dysphagia, or erectile dysfunction; or history of packed red
blood cells (pRBC) transfusion due to PNH.
4. Lactate dehydrogenase (LDH) level =1.5 times the upper limit of normal at screening.
5. Documented meningococcal vaccination not more than 3 years prior to, or at the time
of, initiating study treatment.
6. Female participants of childbearing potential must use highly effective contraception
starting at screening and continuing until at least 8 months after the last dose of
ravulizumab.
7. Willing and able to give written informed consent and comply with study visit
schedule.
Exclusion Criteria:
1. Treatment with a complement inhibitor at any time.
2. History of bone marrow transplantation.
3. Body weight <40 kg.
4. Females who are pregnant, breastfeeding, or who have a positive pregnancy test at
screening or Day 1.
5. Participation in another interventional clinical study or use of any experimental
therapy within 30 days before initiation of study drug on Day 1 in this study or
within 5 half-lives of that investigational product, whichever is greater.
6. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease
that, in the opinion of the investigator or sponsor, would preclude participation.
7. Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal
bleed, severe congestive heart failure, anticipated need for major surgery within 6
months of randomization, coexisting chronic anemia unrelated to PNH).
",NULL,Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels;Percentage Of Participants Who Achieved Transfusion Avoidance (TA),Percentage Of Participants With Breakthrough Hemolysis (BTH);Percent Change From Baseline In Lactate Dehydrogenase (LDH) Levels;Change From Baseline In Quality Of Life As Assessed By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue;Percentage Of Participants With Stabilized Hemoglobin Levels,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-12-20,2016-10-25,2016-10-25,246,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,2020-05-13,TRUE,FALSE,TRUE
18788,NCT00030784,NA,NCT00030784,NCT: 2002-02-14 ICTRP: 2002-02-14 DRKS: NA,0,NA,insufficient,2,1,NA,NA,1,1,NA,5,1,info from description,NA,NA,NA,NCT: Actual 28 ICTRP: 28 DRKS: NA,28,1,0,NA,NA,no info,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.ejca.2006.04.011,NA,2003-01-27,NA,2001-11-30,NA,Interventional,Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma,"Phase I Study To Determine The Safety Of Caelyx (Doxorubin HCI, Pegylated Liposomal) In Combination With Ifosfamide In Previously Untreated Adult Patients With Advanced And/Or Metastatic Soft Tissues Sarcomas",Completed,Phase 1,28,Actual,European Organisation for Research and Treatment of Cancer - EORTC,NA,NA,EORTC-62002;EORTC-62002,Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma,"Phase I Study To Determine The Safety Of Caelyx (Doxorubin HCI, Pegylated Liposomal) In Combination With Ifosfamide In Previously Untreated Adult Patients With Advanced And/Or Metastatic Soft Tissues Sarcomas",,,Interventional,Primary Purpose: Treatment,Phase 1,2002-02-14,2001-11-20,28,Completed,European Organisation for Research and Treatment of Cancer - EORTC,NULL,denmark;germany;denmark;germany,Drug: ifosfamide;Drug: pegylated liposomal doxorubicin hydrochloride,"
DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma
- Advanced and/or metastatic disease
- Must be of any of the following types:
- Malignant fibrous histiocytoma
- Liposarcoma (excluding lipomas and well-differentiated liposarcomas)
- Rhabdomyosarcoma
- Synovial sarcoma
- Malignant paraganglioma
- Fibrosarcoma
- Leiomyosarcoma
- Angiosarcoma
- Neurogenic sarcoma
- Sarcoma not otherwise specified
- Paraffin blocks and slides must be available
- Measurable disease
- Osseous lesions and pleural effusions are not considered measurable disease
- Evidence of progressive disease within the past 6 weeks
- The following conditions are excluded:
- Gastrointestinal stromal tumors
- Malignant mesothelioma
- Chondrosarcoma
- Neuroblastoma
- Osteosarcoma
- Ewing's sarcoma
- Embryonal rhabdomyosarcoma
- No symptomatic or known CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.75 mg/dL
- Albumin at least 2.5 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL
- Creatinine clearance at least 65 mL/min
Cardiovascular:
- Ejection fraction at least 50% by echocardiogram or isotopic methods
- No history of cardiovascular disease
Other:
- No other prior or concurrent primary malignancies except adequately treated carcinoma
in situ of the cervix or basal cell carcinoma
- No other severe medical illness
- No psychosis
- No psychological, familial, sociological, or geographical condition that would
preclude study participation
- Not pregnant
- Fertile patients must use effective contraception (barrier method for men) during and
for 6 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for advanced disease
- No other concurrent systemic chemotherapy for malignancy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to sole indicator lesion
- Concurrent radiotherapy allowed except to sole indicator lesion
Surgery:
- Not specified
Other:
- No other concurrent investigational drugs
",NULL,NULL,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-11-30,2002-02-14,2002-02-14,28,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,2012-09-20,TRUE,FALSE,FALSE
5812,NCT02320045,NA,NCT02320045,NCT: 2014-11-26 ICTRP: 2014-11-26 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 38 ICTRP: 38 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2014-12-19,NA,2014-11-30,2015-07-31,Interventional,Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects,A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function,Completed,Phase 1,38,Actual,Intarcia Therapeutics,"24-h Area under the Curve at steady state (AUCt,ss)",Rate of adverse events;Severity of adverse events;Safety laboratory parameters;Vital signs;Electrocardiogram;Physical exam,ITCA 650 CLP-109,Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects,A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function,NULL,NULL,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 1,2014-11-26,2014-11-20,38,Completed,Intarcia Therapeutics,NULL,united states;germany;united states,Drug: ITCA 650 (Exenatide in osmotic mini pump),"
Inclusion Criteria:
- Body mass index between 22 and 40 kg/m²
- Subjects meeting pre-defined estimated glomerular filtration rate criteria and
creatinine clearance rate
- Normal (=90 mL/min/1.73 m2)
- Mild (60-89 mL/min/1.73 m2)
- Moderate (45-59 mL/min/1.73 m2)
- Moderate (>30-44 mL/min/1.73 m2)
Exclusion Criteria:
- History of acute metabolic complications
- Uncontrolled Hypertension
- History of Hypersensitivity to Exenatide
- Cardiovascular Disease
- History of Acute or chronic pancreatitis
- Personal or family history of Multiple endocrine neoplasia type 2
- History of Medullary thyroid cancer
- Severe renal failure, End stage renal disease or dialysis
",NULL,"24-h Area under the Curve at steady state (AUCt,ss)",Rate of adverse events;Severity of adverse events;Safety laboratory parameters;Vital signs;Electrocardiogram;Physical exam,NCT02320045; ITCA 650 CLP-109,2015-08-12,no,Renal Insufficiency; Unspecified kidney failure,Arm 1 Drug: ITCA 650 (Exenatide in osmotic mini pump),Interventional,Non-randomized controlled trial,Open (masking not used),NA,Parallel,I,"- 24-h Area under the Curve at steady state (AUCt,ss); time frame: Approximately 67 Days
",- Rate of adverse events; time frame: Approximately 67 Days
- Severity of adverse events; time frame: Approximately 67 Days
- Safety laboratory parameters; time frame: Approximately 67 Days
- Vital signs; time frame: Approximately 67 Days
- Electrocardiogram; time frame: Approximately 67 Days
- Physical exam; time frame: Approximately 67 Days
,United States; Germany,[---]* Kiel; [---]* Mannheim; [---]* Moenchengladbach,2014-11-30,NA,40,NA,- Body mass index between 22 and 40 kg/m²
- Subjects meeting pre-defined estimated glomerular filtration rate criteria and
creatinine clearance rate
- Normal (≥90 mL/min/1.73 m2)
- Mild (60-89 mL/min/1.73 m2)
- Moderate (45-59 mL/min/1.73 m2)
- Moderate (>30-44 mL/min/1.73 m2)
,"- History of acute metabolic complications
- Uncontrolled Hypertension
- History of Hypersensitivity to Exenatide
- Cardiovascular Disease
- History of Acute or chronic pancreatitis
- Personal or family history of Multiple endocrine neoplasia type 2
- History of Medullary thyroid cancer
- Severe renal failure, End stage renal disease or dialysis
",A Phase 1 Study to Evaluate the Pharmacokinetics of ITCA 650 in Subjects With Mild and Moderate Renal Impairment Compared to the Pharmacokinetics of Subjects With Normal Renal Function,Recruiting ongoing,Intarcia Therapeutics; [---]*; [---]*,[---]*; clinicaltrials@intarcia.com; clinicaltrials@intarcia.com,Arm 1 Drug: ITCA 650 (Exenatide in osmotic mini pump),2014-11-30,2014-11-26,2014-11-26,38,Interventional,FALSE,FALSE,TRUE,FALSE,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,2014,2016-06-02,TRUE,TRUE,FALSE
15505,NCT00567346,NA,NA,NCT: 2007-12-03 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,3,NA,"no AM, no measure",NCT: Actual 605 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-12-04,NA,2006-12-31,2008-03-31,Interventional,Efficacy and Safety of Grass Pollen Sublingual Immunotherapy,"A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis",Completed,Phase 2/Phase 3,605,Actual,Artu Biologicals,Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS),"Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.",2006-001548-30;AB0602,Efficacy and Safety of Grass Pollen Sublingual Immunotherapy,"A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2/Phase 3,2007-12-03,2006-12-20,605,Completed,Artu Biologicals,NULL,bulgaria;czech republic;germany;hungary;lithuania;netherlands;slovakia;bulgaria;czech republic;germany;hungary;lithuania;netherlands;slovakia,Drug: Oralgen;Drug: grass pollen extract,"
Inclusion Criteria:
- male or female aged 18-50
- patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen
seasons
- Positive skin prick test and IgE value of at least Class 2+
- RTSS of greater or equal to 14 during pollen season prior tot the start of the study
- Patients must be in general good health
- Patients with normal spirometry
- Informed consent given and willing to comply with the protocol
- Female patients are eligible if they use an accepted contraceptive method
- Negative urine pregnancy test if female
Exclusion Criteria:
- Pregnancy, breast feeding
- Asthma requiring treatment other than beta-2 inhaled agonists
- patients who have taken oral steroids within 12 weeks before screening visit
- patients who have received desensitisation treatment for grass pollen
- treatment by immunotherapy with any other allergen within the previous 5 years
- patients who have suffered a lower respiratory tract infection within 4 weeks or an
upper respiratory tract infection within 2 weeks of the screening visit
- patients at risk of non-compliance
- participation in any other clinical study within the previous 3 months
- patients with a past or current disease, which may affect participation in or outcome
of this study.
- patients treated with beta-blockers or under continuous corticotherapy
- allergic sensitivity to epithelial allergens the patients is exposed to
- positive skin prick test for environmental allergens and suffering from serious
allergic symptoms due to exposure to these allergens during study period
- intention to subject the patient to surgery of the nasal cavity during current study
- Usual contraindications of immunotherapy
- a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to
tree pollen or weed pollen adjacent to the start of, and potentially overlapping the
grass pollen season
",NULL,Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS),"Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-12-31,2007-12-03,2007-12-03,605,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2006,2010-05-04,TRUE,FALSE,TRUE
14001,NCT00839163,NA,NA,NCT: 2009-02-06 ICTRP: NA DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",4,NA,no measure,NCT: Actual 613 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no indication,kein Artikel,NA,NA,2009-02-09,NA,2004-03-31,2005-10-31,Interventional,Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT),"ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.",Completed,Phase 2,613,Actual,Bayer,Response to treatment as determined by a Complete Compression Ultra sound (CCUS),Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period;Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug;Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan;Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS);Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT),2004-001083-43;ODIXa-DVT;11223,Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT),"ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2,2009-02-06,2004-03-20,613,Completed,Bayer,NULL,australia;austria;belgium;brazil;canada;colombia;czech republic;germany;hungary;israel;italy;netherlands;new zealand;peru;poland;south africa;spain;sweden;switzerland;australia;austria;belgium;brazil;canada;colombia;czech republic;germany;hungary;israel;italy;netherlands;new zealand;peru;poland;south africa;spain;sweden;switzerland,"Drug: Xarelto (Rivaroxaban, BAY59-7939);Drug: Xarelto (Rivaroxaban, BAY59-7939);Drug: Xarelto (Rivaroxaban, BAY59-7939);Drug: Xarelto (Rivaroxaban, BAY59-7939);Drug: Enoxaparin/Vitamin K-Antagonist",
Inclusion Criteria:
- Patients with acute symptomatic proximal deep vein thrombosis
Exclusion Criteria:
- Contraindication to comparator drugs
- Symptomatic Pulmonary embolism
- Conditions with increased bleeding risk
- Unstable patients with reduced life expectancy
- Severe renal impairment
- Impaired liver function
- Strong CYP 3A4 inhibitors
- Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with
anticoagulants or fibrinolytics
- NSAIDs with half-life > 17 hours
,NULL,Response to treatment as determined by a Complete Compression Ultra sound (CCUS),Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan;Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS);Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT);Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period;Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-03-31,2009-02-06,2009-02-06,613,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2004,2014-10-27,TRUE,FALSE,FALSE
17000,NCT00342316,NA,NCT00342316,NCT: 2006-06-20 ICTRP: 2006-06-20 DRKS: NA,1,NA,NA,1,NA,NA,NA,1,NA,NA,5,NA,NA,4,NA,no AM,NCT: Actual 360 ICTRP: 360 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,Abstract,https://doi.org/10.1182/blood.V130.Suppl_1.4557.4557,NA,2006-06-21,NA,2003-12-18,2018-07-20,Interventional,Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia,Prospective Controlled Clinical Study of Allogeneic Stem Cell Transplantation With Reduced Conditioning (RICT) Versus Best Standard of Care in Acute Myeloid Leukemia (AML)in First Complete Remission (CR),Completed,N/A,340,Actual,Vastra Gotaland Region,Overall survival (OS),Disease-free survival;Quality of Life for pts in the RICT and Control Groups.;Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts;Acute and Chronic Graft-versus-Host Disease (GvHD),TRALG1/02,Reduced Intensity Conditioning Transplantation Versus Standard of Care in Acute Myeloid Leukemia,Prospective Controlled Clinical Study of Allogeneic Stem Cell Transplantation With Reduced Conditioning (RICT) Versus Best Standard of Care in Acute Myeloid Leukemia (AML)in First Complete Remission (CR),,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2006-06-20,2003-12-18,340,Completed,Vastra Gotaland Region,The Canadian Blood and Marrow Transplant Group;Australasian Leukaemia and Lymphoma Group,australia;canada;estonia;finland;germany;greece;new zealand;norway;sweden;australia;canada;estonia;finland;germany;greece;new zealand;norway;sweden;israel,Procedure: Reduced Intensity Conditioning Stem Cell Transplantation,
Inclusion Criteria:
- Newly diagnosed patients with de novo or secondary AML
- Intermediate or poor risk
- In first complete remission
- Age 51-70 years
- Fit for the procedure
- Fit for further consolidation chemotherapy
Exclusion Criteria:
- Planned for a full-dose allogeneic transplant
,NULL,Overall survival (OS),Disease-free survival;Quality of Life for pts in the RICT and Control Groups.;Non-relapse mortality (NRM). Numbers and causes of death in non-relapsed pts;Acute and Chronic Graft-versus-Host Disease (GvHD),NCT00342316; TRALG1/02,2014-11-24,yes,Acute Myeloid Leukemia; Acute myeloblastic leukaemia [AML],Arm 1 Procedure: Reduced Intensity Conditioning Stem Cell Transplantation,Interventional,Randomized controlled trial,Open (masking not used),Control group receives no treatment,Parallel,III,"- Overall survival at 3 years after inclusion; time frame: From inclusion until death from any cause or after 36 months, whichever comes first
","- Time to relapse from inclusion up to 3 years; time frame: Time between inclusion and date of relapse or after 36 months, whichever comes first.
- Quality of life at baseline, 12 and 24 months post inclusion; time frame: From inclusion (baseline) until relapse or death from any cause or at 12 and 24 months, whichever comes first.
- In RICT patients only: Safety and feasibility of the procedure from inclusion to 3 years; time frame: Non-relapse mortality (NRM) and overall survival at two occasions up to 36 months after inclusion.
- In RICT patients: Incidence & severity of acute and chronic GvHD from transplantation to three years after inclusion; time frame: From transplantation until end of study, up to 36 months after inclusion.
- In RICT patients: Rate of complete or partial chimerism from transplant to 3 months; time frame: At Day +100 post Tx
",Australia; Canada; Estonia; Finland; Germany; Greece; New Zealand; Norway; Sweden,[---]* Freiburg,2003-12-31,NA,352,NA,- Newly diagnosed patients with de novo or secondary AML
- Intermediate or poor risk
- In first complete remission
- Age 51-70 years
- Fit for the procedure
- Fit for further consolidation chemotherapy
,- Planned for a full-dose allogeneic transplant
,Prospective Controlled Clinical Study of Allogeneic Stem Cell Transplantation With Reduced Conditioning (RICT) Versus Best Standard of Care in Acute Myeloid Leukemia (AML)in First Complete Remission (CR),"Recruiting complete, follow-up continuing",Vastra Gotaland Region; Göteborg University; Göteborg University,[---]*; [---]*; [---]*,Arm 1 Procedure: Reduced Intensity Conditioning Stem Cell Transplantation,2003-12-18,2006-06-20,2006-06-20,340,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,2003,2020-01-23,TRUE,TRUE,FALSE
12000,NCT01179789,NA,NCT01179789,NCT: 2010-08-05 ICTRP: 2010-08-05 DRKS: NA,1,1,NA,2,1,r,criteria more specific in register,2,1,NA,3,1,"no metric, no AM",3,1,"no metric, no AM",NCT: Anticipated 48 ICTRP: 48 DRKS: NA,138,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.clnu.2015.06.010,NA,2010-08-11,NA,2009-10-31,2011-06-30,Interventional,New E-Service for a Dietary Approach to the Elderly,"Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. German Part of a Multicentric European Study",Completed,Early Phase 1,48,Anticipated,"Charite University, Berlin, Germany",High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk),Inflammageing status as measure of ageing-associated inflammatory processes;Oxidative stress;Gut micobiota;Quality of life (QoL);Physical performance status;Compliance,EA1/079/09,New E-Service for a Dietary Approach to the Elderly,"Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. German Part of a Multicentric European Study",NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention",Phase 0,2010-08-05,2009-10-20,48,Completed,"Charite University, Berlin, Germany",NULL,germany,Behavioral: Optimal Diet;Dietary Supplement: VSL#3®;Dietary Supplement: AISA-5203-L;Dietary Supplement: Argan oil,"
Inclusion Criteria:
- Age: from 65 to 85 years
- Body Mass Index: 22-30 kg/m2
- ECOG Performance status: WHO performance score 0 to 2
- Absence of known diseases and/or abnormalities of haematological parameters
(haematological, inflammatory, metabolic, hepatic and renal diseases)
- The subjects must be able to comply with management of nutraceutical products and
with scheduled follow-up
- The subjects must be able to use the computer and to access to the web, by themselves
or with the help of a caregiver
Exclusion Criteria:
- History of significant neurologic or psychiatric disorders including dementia,
seizures, bipolar disorder
- Geriatric anorexia [less than 2 full meals per day and /or less than one serving of
dairy products (milk, cheese, yogurt) per day or two or more servings of legumes or
eggs per week or one serving of meat, fish or poultry every day]
- Weight loss > 5% in the last month
- Previous antibiotic treatment within 4 months
- Active infection requiring per OS or IV antibiotics, including active tuberculosis,
known and declared HIV, HCV
- Constipation and/or abdominal pain/discomfort that require dietary supplements or
medical therapy
- Gastric disease that requires medical therapy (e.g. gastric secretion inhibitory
drugs)
- Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis,
diverticulosis, diverticulitis)
- Diabetes mellitus
- Dislipidemia and/or any metabolic disease that requires medical or dietetic treatment
- Myocardial infarction within 6 months prior to study entry, congestive heart disease,
uncontrolled cardiac insufficiency, and any current grade 3 or 4 cardio-vascular
disorder despite treatment
- Current history of neoplasm except for curatively treated non melanoma skin cancer or
in situ carcinoma of the cervix and except for other cancer curatively treated and
with no evidence of disease for at least 5 years
- Other sever underlying medical conditions, which could impair the ability of the
patient to participate in the study
- Chronic anti-inflammatory therapy with FANS or previous therapy within 20 days from
the beginning of the study. The occasional use of anti-inflammatory therapy is not an
exclusion criteria, but the use is not allowed within 3 days before the analysis and
for more than 8 days/2 months during the study
- Previous (within 15 days) or concomitant treatment that modifies intestinal
absorption (e.g. metformin, acarbose in diabetic treatment…)
- Probiotics, prebiotics or symbiotics (yogurt or another functional foods) intake in
the last 3 weeks
- Use of food supplements or functional foods such as probiotics, prebiotics,
symbiotics, vitamins and minerals different than whose established in this study, is
not allowed during the study period or previously within 1 week (except for vitamin
D, calcium, vitamin B12)
- Total parenteral nutrition within 4 months
- History of allergy to one of the excipients present in the products under evaluation
- Concomitant or within 4 week period administration of any experimental drug, food
supplements or nutraceuticals under investigation
- Subjects clearly intending to withdraw from the study if not randomised in a given
arm, or subjects who cannot be regularly followed up for psychological, social,
familial or geographic reasons
- Subjects with expected non-compliance to protocol guidelines
",NULL,High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk),Inflammageing status as measure of ageing-associated inflammatory processes;Oxidative stress;Gut micobiota;Quality of life (QoL);Physical performance status;Compliance,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-10-31,2010-08-05,2010-08-05,48,Interventional,TRUE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2009,2011-10-27,TRUE,FALSE,FALSE
12646,NCT01073358,NA,NCT01073358,NCT: 2010-02-22 ICTRP: 2010-02-22 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no measure,NA,NA,NA,NCT: Anticipated 166 ICTRP: 166 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,Poster,10.1007/s00104-015-0133-6,NA,2010-02-23,NA,2010-03-09,2021-12-31,Interventional,Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy,Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial,Enrolling by invitation,N/A,166,Anticipated,Heidelberg University,rate of disease recurrence,,NNR-5,Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy,Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial,;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). ",N/A,2010-02-22,2010-03-09,166,Enrolling by invitation,Heidelberg University,NULL,germany;germany;germany;germany;germany,Procedure: Routine hilar lymphadenectomy;Procedure: Routine hilar lymphadenectomy;Procedure: Routine hilar lymphadenectomy;Procedure: Routine hilar lymphadenectomy,"
Inclusion Criteria:
- Patients scheduled for curative (R0) resection
- No evidence of extrahepatic disease
- No history of previous hepatic lymphadenectomy
- Age equal or greater than 18 years
- Written Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer or curatively resected non-melanoma
skin cancer
- Other primary solid tumour curatively treated with no known active disease
present and no treatment administered for = 5 years prior to randomisation
;
Inclusion Criteria:
- Patients scheduled for curative (R0) resection
- No evidence of extrahepatic disease
- No history of previous hepatic lymphadenectomy
- Age equal or greater than 18 years
- Written Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer or curatively resected non-melanoma
skin cancer
- Other primary solid tumour curatively treated with no known active disease
present and no treatment administered for = 5 years prior to randomisation
;
Inclusion Criteria:
- Patients scheduled for curative (R0) resection
- No evidence of extrahepatic disease
- No history of previous hepatic lymphadenectomy
- Age equal or greater than 18 years
- Written Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer or curatively resected non-melanoma
skin cancer
- Other primary solid tumour curatively treated with no known active disease
present and no treatment administered for = 5 years prior to randomisation
;
Inclusion Criteria:
- Patients scheduled for curative (R0) resection
- No evidence of extrahepatic disease
- No history of previous hepatic lymphadenectomy
- Age equal or greater than 18 years
- Written Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer or curatively resected non-melanoma
skin cancer
- Other primary solid tumour curatively treated with no known active disease
present and no treatment administered for = 5 years prior to randomisation
",NULL,rate of disease recurrence;rate of disease recurrence;rate of disease recurrence,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-03-09,2010-02-22,2010-02-22,166,Interventional,TRUE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2010,2017-10-26,TRUE,FALSE,FALSE
10740,NCT01374399,NA,NCT01374399,NCT: 2011-04-18 ICTRP: 2011-04-18 DRKS: NA,1,NA,NA,1,NA,NA,NA,1,NA,wrong description of relaxation intervention,5,NA,NA,4,NA,no AM,NCT: Anticipated 256 ICTRP: 256 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Studienprotokoll,https://doi.org/10.1186/s12885-015-1631-0,NA,2011-06-16,NA,2011-02-28,2019-07-31,Interventional,Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA),"Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation",Completed,N/A,267,Actual,German Cancer Research Center,Overall survival,"Fatigue;Quality of Life;Hemoglobin, Leukocytes, Thrombocytes;Side-effects (Infections, GvHD, Depression, Distress);Adherence to exercise protocol;Muscular strength;cardiorespiratory fitness;IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin;median survival, non-relapse mortality",DJCLS R 10/42pf,Physical Exercise Therapy vs Relaxation in Allogeneic Stem Cell Transplantation (PETRA),"Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation",;;,;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). ,N/A,2011-04-18,2011-02-20,267,Completed,German Cancer Research Center,"National Center for Tumor Diseases, Heidelberg;University Hospital Heidelberg;Central Institute of Mental Health, Mannheim",germany,Behavioral: exercise and relaxation,
Inclusion Criteria:
- Medical indication: allogeneic stem cell transplantation
Exclusion Criteria:
- Orthopeadic limitations that hamper the exercise intervention
- Osseous degenerations that have an improved fracture risk
,NULL,Overall survival,"Fatigue;Quality of Life;Hemoglobin, Leukocytes, Thrombocytes;Side-effects (Infections, GvHD, Depression, Distress);Adherence to exercise protocol;Muscular strength;cardiorespiratory fitness;IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin;median survival, non-relapse mortality",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-02-28,2011-04-18,2011-04-18,267,Interventional,TRUE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,FALSE,NA,TRUE,2011,2019-12-20,TRUE,FALSE,FALSE
15191,NCT00634192,NA,NCT00634192,NCT: 2008-03-04 ICTRP: 2008-03-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,NA,NCT: Anticipated 50 ICTRP: 50 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2008-03-12,NA,2008-02-29,2009-08-31,Interventional,Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin,"A Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) Subjects",Completed,Phase 3,50,Anticipated,Novartis,To evaluate the serum pharmacokinetics (PK) of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebuliser Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects,"Serum PK of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 1 x 300mg/d tobramycin nebulized solution (= TNS) inhaled with the PARI eFlow rapid in cystic fibrosis subjects.;Compare serum PK of inhaled tobramycin (trough-/peak-level)of both dosing regimens in CF-subjects with a FEV1≥80% vs. CF-Subjects with a FEV1<80%.;Change of MIC of P. aeruginosa during a continuous treatment with 1 x 300 mg/d and 2 x 300 mg/d TNS.;Assess safety of a continuous daily dosing regimen with 1 x 300 mg/d and 2 x 300 mg/d TNS over 8 weeks, compared to historic safety data of the 4 week on/off dosing regimen with 2 x 300 mg/d.",CTBM100DDE01,Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin,"A Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) Subjects",;;;;,;;;;,Interventional,Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2008-03-04,2008-02-20,50,Completed,Novartis,NULL,germany;germany;germany;germany;germany,Drug: tobramycin;Drug: tobramycin;Drug: tobramycin;Drug: tobramycin;Drug: tobramycin;Drug: tobramycin;Drug: tobramycin;Drug: tobramycin,"
Inclusion Criteria:
- Male and female subjects aged =6 years at the time of screening, with an Informed
Consent Form signed by patient and if appropriate by parent/legal guardians, prior to
any study-related procedure.
- Confirmed diagnosis of CF by the presence of one or more clinical features of CF in
addition to a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L;
or identification of well-characterized disease-causing mutations in each CFTR gene;
or an abnormal nasal transepithelial potential difference characteristic of CF.
- P aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage
[BAL]) at the screening visit and within 6 months prior to screening.
Exclusion Criteria:
- History of sputum (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2
years prior to screening and/or sputum culture yielding B cepacia at screening.
- FEV1 <25% of normal predicted values for age, sex, and height based on Knudson
criteria at screening.
- Hemoptysis of more than 60 cc at any time within 30 days prior to study drug
administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- GFR<60ml/min/1.73m2 calculated with the Formula by Schwartz, BUN 40 mg/dl or more, or
an abnormal urinalysis defined as 2+ or greater proteinuria.
- History of tinnitus or pathologic audiometry
- diagnosis of Allergic bronchopulmonary aspergillosis (ABPA) at screening
- Initiation of treatment with macrolide antibiotics within 28 days prior to study drug
administration (subjects may be taking macrolide antibiotics at the time of
enrollment, but they must have initiated treatment at least 28 days prior to study
drug administration).
- Use of loop diuretics within 7 days prior to study drug administration.
Other protocol-defined inclusion/exclusion criteria may apply
;
Inclusion Criteria:
- Male and female subjects aged =6 years at the time of screening, with an Informed
Consent Form signed by patient and if appropriate by parent/legal guardians, prior to
any study-related procedure.
- Confirmed diagnosis of CF by the presence of one or more clinical features of CF in
addition to a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L;
or identification of well-characterized disease-causing mutations in each CFTR gene;
or an abnormal nasal transepithelial potential difference characteristic of CF.
- P aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage
[BAL]) at the screening visit and within 6 months prior to screening.
Exclusion Criteria:
- History of sputum (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2
years prior to screening and/or sputum culture yielding B cepacia at screening.
- FEV1 <25% of normal predicted values for age, sex, and height based on Knudson
criteria at screening.
- Hemoptysis of more than 60 cc at any time within 30 days prior to study drug
administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- GFR<60ml/min/1.73m2 calculated with the Formula by Schwartz, BUN 40 mg/dl or more, or
an abnormal urinalysis defined as 2+ or greater proteinuria.
- History of tinnitus or pathologic audiometry
- diagnosis of Allergic bronchopulmonary aspergillosis (ABPA) at screening
- Initiation of treatment with macrolide antibiotics within 28 days prior to study drug
administration (subjects may be taking macrolide antibiotics at the time of
enrollment, but they must have initiated treatment at least 28 days prior to study
drug administration).
- Use of loop diuretics within 7 days prior to study drug administration.
Other protocol-defined inclusion/exclusion criteria may apply
;
Inclusion Criteria:
- Male and female subjects aged =6 years at the time of screening, with an Informed
Consent Form signed by patient and if appropriate by parent/legal guardians, prior to
any study-related procedure.
- Confirmed diagnosis of CF by the presence of one or more clinical features of CF in
addition to a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L;
or identification of well-characterized disease-causing mutations in each CFTR gene;
or an abnormal nasal transepithelial potential difference characteristic of CF.
- P aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage
[BAL]) at the screening visit and within 6 months prior to screening.
Exclusion Criteria:
- History of sputum (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2
years prior to screening and/or sputum culture yielding B cepacia at screening.
- FEV1 <25% of normal predicted values for age, sex, and height based on Knudson
criteria at screening.
- Hemoptysis of more than 60 cc at any time within 30 days prior to study drug
administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- GFR<60ml/min/1.73m2 calculated with the Formula by Schwartz, BUN 40 mg/dl or more, or
an abnormal urinalysis defined as 2+ or greater proteinuria.
- History of tinnitus or pathologic audiometry
- diagnosis of Allergic bronchopulmonary aspergillosis (ABPA) at screening
- Initiation of treatment with macrolide antibiotics within 28 days prior to study drug
administration (subjects may be taking macrolide antibiotics at the time of
enrollment, but they must have initiated treatment at least 28 days prior to study
drug administration).
- Use of loop diuretics within 7 days prior to study drug administration.
Other protocol-defined inclusion/exclusion criteria may apply
;
Inclusion Criteria:
- Male and female subjects aged =6 years at the time of screening, with an Informed
Consent Form signed by patient and if appropriate by parent/legal guardians, prior to
any study-related procedure.
- Confirmed diagnosis of CF by the presence of one or more clinical features of CF in
addition to a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L;
or identification of well-characterized disease-causing mutations in each CFTR gene;
or an abnormal nasal transepithelial potential difference characteristic of CF.
- P aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage
[BAL]) at the screening visit and within 6 months prior to screening.
Exclusion Criteria:
- History of sputum (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2
years prior to screening and/or sputum culture yielding B cepacia at screening.
- FEV1 <25% of normal predicted values for age, sex, and height based on Knudson
criteria at screening.
- Hemoptysis of more than 60 cc at any time within 30 days prior to study drug
administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- GFR<60ml/min/1.73m2 calculated with the Formula by Schwartz, BUN 40 mg/dl or more, or
an abnormal urinalysis defined as 2+ or greater proteinuria.
- History of tinnitus or pathologic audiometry
- diagnosis of Allergic bronchopulmonary aspergillosis (ABPA) at screening
- Initiation of treatment with macrolide antibiotics within 28 days prior to study drug
administration (subjects may be taking macrolide antibiotics at the time of
enrollment, but they must have initiated treatment at least 28 days prior to study
drug administration).
- Use of loop diuretics within 7 days prior to study drug administration.
Other protocol-defined inclusion/exclusion criteria may apply
",NULL,To evaluate the serum pharmacokinetics (PK) of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebuliser Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects;To evaluate the serum pharmacokinetics (PK) of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebuliser Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects;To evaluate the serum pharmacokinetics (PK) of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebuliser Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects,"Serum PK of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 1 x 300mg/d tobramycin nebulized solution (= TNS) inhaled with the PARI eFlow rapid in cystic fibrosis subjects.;Compare serum PK of inhaled tobramycin (trough-/peak-level)of both dosing regimens in CF-subjects with a FEV1=80% vs. CF-Subjects with a FEV1<80%.;Change of MIC of P. aeruginosa during a continuous treatment with 1 x 300 mg/d and 2 x 300 mg/d TNS.;Assess safety of a continuous daily dosing regimen with 1 x 300 mg/d and 2 x 300 mg/d TNS over 8 weeks, compared to historic safety data of the 4 week on/off dosing regimen with 2 x 300 mg/d.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-02-29,2008-03-04,2008-03-04,50,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2008,2017-02-22,TRUE,FALSE,TRUE
10977,NCT01335464,NA,CTRI/2011/12/002248,NCT: 2011-04-13 ICTRP: 2011-12-16 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,5,NA,NA,4,NA,no AM,NCT: Actual 515 ICTRP: 485 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2011-04-14,NA,2011-04-30,2013-10-31,Interventional,Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients,"A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)",Completed,Phase 3,515,Actual,Boehringer Ingelheim,Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks,"Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks;Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation;Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks;Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks;Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks;Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks;Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold;Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold;FVC Responders Using 10% Threshold at 52 Weeks;Proportion of FVC Responders Using 5% Threshold at 52 Weeks;Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs);Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs);Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs);Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs);Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs);Risk of an Acute IPF Exacerbation Over 52 Weeks;Time to Death Over 52 Weeks;Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated);Time to On-treatment Death;Time to Death or Lung Transplant Over 52 Weeks;Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.;Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks;Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks",2010-024251-87;1199.32,Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients,"A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)",;;;,;;;,Interventional,,Phase 3,2011-04-13,2011-04-20,515,Completed,Boehringer Ingelheim,NULL,united states;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;united states;argentina;brazil;united states;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;united states;argentina;brazil;united states;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;united states;argentina;brazil;united states;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;australia;belgium;china;czech republic;france;germany;india;ireland;israel;italy;japan;united kingdom;united states;argentina;brazil,Drug: placebo;Drug: BIBF 1120;Drug: placebo;Drug: BIBF 1120;Drug: placebo;Drug: BIBF 1120;Drug: placebo;Drug: BIBF 1120,"
Inclusion criteria:
1. Age >= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European
Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic
Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if
available surgical lung biopsy pattern, as assessed by central reviewers, are
consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal;
5. FVC>= 50% predicted of normal
Exclusion criteria:
1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit
of Normal (ULN)
2. Bilirubin > 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation
list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic
anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event
within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or
ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including
stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and
partial thromboplastin time (PTT) by > 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit
1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of
visit 1;
;
Inclusion criteria:
1. Age >= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European
Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic
Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if
available surgical lung biopsy pattern, as assessed by central reviewers, are
consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal;
5. FVC>= 50% predicted of normal
Exclusion criteria:
1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit
of Normal (ULN)
2. Bilirubin > 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation
list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic
anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event
within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or
ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including
stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and
partial thromboplastin time (PTT) by > 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit
1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of
visit 1;
;
Inclusion criteria:
1. Age >= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European
Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic
Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if
available surgical lung biopsy pattern, as assessed by central reviewers, are
consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal;
5. FVC>= 50% predicted of normal
Exclusion criteria:
1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit
of Normal (ULN)
2. Bilirubin > 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation
list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic
anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event
within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or
ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including
stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and
partial thromboplastin time (PTT) by > 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit
1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of
visit 1;
;
Inclusion criteria:
1. Age >= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European
Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic
Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if
available surgical lung biopsy pattern, as assessed by central reviewers, are
consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal;
5. FVC>= 50% predicted of normal
Exclusion criteria:
1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit
of Normal (ULN)
2. Bilirubin > 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation
list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic
anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event
within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or
ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including
stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and
partial thromboplastin time (PTT) by > 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit
1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of
visit 1;
",NULL,Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks;Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks,"Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks;Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation;Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks;Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks;Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks;Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks;Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold;Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold;FVC Responders Using 10% Threshold at 52 Weeks;Proportion of FVC Responders Using 5% Threshold at 52 Weeks;Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs);Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs);Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs);Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs);Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs);Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs);Risk of an Acute IPF Exacerbation Over 52 Weeks;Time to Death Over 52 Weeks;Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated);Time to On-treatment Death;Time to Death or Lung Transplant Over 52 Weeks;Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.;Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks;Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-04-30,2011-04-13,2011-04-13,515,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2011,2016-06-24,TRUE,FALSE,TRUE
17993,NCT00176124,NA,NA,NCT: 2005-09-11 ICTRP: NA DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,4,NA,no measure,5,NA,NA,NCT: Actual 1089 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2005-09-15,NA,2001-04-30,2005-09-30,Interventional,Leukocyte Depletion of Autologous Whole Blood,Leukocyte Depletion of Autologous Whole Blood: Impact on Perioperative Infection Rate and Length of Hospital Stay for Hip Arthroplasty Patients,Completed,Phase 4,1089,Actual,Heidelberg University,"Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay",Blood loss and transfusion rate,ISRCTN 99578441;UniKlinMa-TF-2001-1,Leukocyte Depletion of Autologous Whole Blood,Leukocyte Depletion of Autologous Whole Blood: Impact on Perioperative Infection Rate and Length of Hospital Stay for Hip Arthroplasty Patients,,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 4,2005-09-11,2001-04-20,1089,Completed,Heidelberg University,Philipps University Marburg Medical Center,germany,Procedure: leukocyte depletion of whole blood;Other: Leukocyte filtration/Depletion,"
Inclusion Criteria:
- • ASA I-III,
- Age 18-85 years,
- Body weight 50-125 kg
- If female, with either a history of an accepted method of anticonception for at
least 3 month prior and 1 month following the termination of the study or
climacteric or with a negative betA- HCG-Test in urine or serum.
- Preoperative blood donation of at least 2 units (450mL whole blood)
- Preoperative hemoglobin level > 10 mg/dL
- Able and willing to sign informed consent
Exclusion Criteria:
- Subjects with a contraindication for preoperative blood donation (PAD) (in 12, PP
36-43).
- systemic infection
- acute bacterial or viral diseases
- anemia (Hb > 11g/dL)
- myocardial infarction within the past 6 month,
- instable angina pectoris
- vascular stenosis (i.e. of the coronary or internal carotid arteries)
- hemodynamic relevant valvular stenosis
- heart failure > NYHA II
- history of strokes or TIA
- steroid therapy,
- immune deficiency,
- hematological or endocrinological disease,
- coagulopathy,
- history of organ transplantation,
- simultaneous participation in a second study
- pregnancy
- membership at Jehovah's Witnesses
- intended use of a cell saver
",NULL,"Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay",Blood loss and transfusion rate,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-04-30,2005-09-11,2005-09-11,1089,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2001,2008-06-09,TRUE,FALSE,FALSE
14867,NCT00690898,NA,NA,NCT: 2008-06-03 ICTRP: NA DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 108 ICTRP: NA DRKS: NA,90,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://academic.oup.com/jcem/article/99/4/1282/2537335,NA,2008-06-05,NA,2008-05-31,2012-02-29,Interventional,Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma,"Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma",Completed,Phase 3,108,Actual,Ipsen,Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5),"Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).;Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels;Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.;Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline;Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline",2007-000155-34;2-79-52030-207,Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma,"Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma",,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2008-06-03,2008-05-20,108,Completed,Ipsen,NULL,belgium;czechia;finland;france;germany;italy;netherlands;turkey;united kingdom;belgium;czechia;finland;france;germany;italy;netherlands;turkey;united kingdom;czech republic;spain;sweden,Drug: Lanreotide autogel 120 mg,"
Inclusion Criteria:
- The patient has given written informed consent prior to any study related procedures
- The patient is male or female and is aged between 18 and 75 years, inclusive,
- Diagnosis of acromegaly defined by i) GH nadir > 1 ng/mL as assessed by an oral
glucose tolerance test for non diabetic patients (central laboratory results) or a
mean GH level > 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic
patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the
age- and sex-matched normal range for diabetic and non diabetic patients (central
laboratory results),
- The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm
based on Magnetic Resonance Imaging (MRI) central reading,
- The patient has no visual field defect identified at the visual evaluation, performed
by Goldman Visual Fields Analyser and Automated visual field static perimeter, except
visual field abnormality at the time of screening and that is in the investigator's
Clinical judgement:
- Not related to the pituitary adenoma
- Clinically stable condition not presumed to change during the study period
- Not modifying the ability to evaluate visual field changes related to the
macroadenoma
Exclusion Criteria:
- The patient has a history of hypersensitivity to Lanreotide or drugs with a similar
chemical structure,
- The patient has received any unlicensed drug within the 30 days prior to the screening
visit or is scheduled to receive an unlicensed drug during the course of the study,
- The patient is likely to require treatment during the study with somatostatin
analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor
antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the
study protocol,
- The patient is a female at risk of pregnancy during the study and is not using
acceptable contraceptive methods. Females of childbearing potential must provide a
negative pregnancy test at start of study and must be using oral, double barrier
(condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide;
or male condom and diaphragm with spermicide), injectable contraception or an intra
uterine device. Non childbearing potential is defined as post-menopause for at least 1
year, surgical sterilisation or hysterectomy at least three months before the start of
the study,
- The patient is pregnant or lactating,
- The patient has a history of, or known current, problems with alcohol abuse,
- The patient has any mental condition rendering the patient unable to understand the
nature, scope and possible consequences of the study, and/or evidence of an
uncooperative attitude.
- The patient has abnormal baseline findings, any other medical condition(s) or
laboratory findings that, in the opinion of the Investigator, might jeopardize the
patient's safety or decrease the chance of obtaining satisfactory data needed to
achieve the objective(s) of the study,
- The patient has undergone pituitary surgery or pituitary radiotherapy prior to study
entry,
- The patient has previously been treated with a somatostatin analogue,
- The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant)
prior to study entry,
- The patient is expected to require pituitary surgery (adenomectomy) or to receive
radiotherapy during the study period,
- Patients with suspected associated prolactinoma: prolactin level > 100 ng/mL (central
laboratory results),
- Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe
renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2),
- Patient known by Investigator, to have congenital or acquired optic nerve disease or
any visual abnormality with risk of worsening during the course of the study (e.g
glaucoma), influencing ability to evaluate Visual Field changes related to the
macroadenoma.
",NULL,Percentage of Patients With Relevant Reduction in Pituitary Tumour Volume (as Measured by MRI) From Baseline Volume (Visit 1) to Week 48 (After 12 Injections at Visit 5),"Number of Patients With at Least a 20% Reduction in Tumour Volume From Baseline Volume (Visit 1) to Week 12 (Visit 3) and Week 24 (Visit 4).;Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of IGF-1 Levels;Percent Variation From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Serum GH Levels.;Change From Baseline to Visit 3, 4 and 5 (Week 12, 24, and 48) of Prolactin Levels;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Arthralgia) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Excessive Perspiration) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Fatigue) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Headache) From Baseline;Percentage of Patients With Improved, Unchanged or Worsened Clinical Signs of Acromegaly (Soft Tissue Swelling) From Baseline;Changes in the Global Acromegaly Quality of Life Assessment (AcroQoL) From Baseline",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-05-31,2008-06-03,2008-06-03,108,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2008,2019-01-10,TRUE,FALSE,TRUE
9794,NCT01523028,NA,NCT01523028,NCT: 2012-01-27 ICTRP: 2012-01-27 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no measure (which phenolics),4,NA,no AM,NCT: Actual 14 ICTRP: 14 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2012-02-01,NA,2011-09-30,2012-12-31,Interventional,Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans,NA,Completed,N/A,14,Actual,Nestlé,Sum of plasma areas under the curve of coffee phenolics,"Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids;Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose",11.12.NRC,Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans,,NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science",N/A,2012-01-27,2011-09-20,14,Completed,Nestlé,NULL,germany,Other: Soluble Coffee,
Inclusion Criteria:
- Healthy men and women
- Aged 20-44 years
- Caucasian origin
- Body mass index (BMI) 19-25 kg/m2
- Used to drinking coffee (similar to study coffee) on a daily basis
- Being able to tolerate a 48-hour coffee abstinence
- Normal oral glucose tolerance test
- Having signed the informed consent form
Exclusion Criteria:
- Taking medication or dietary supplements
- Smoking
- Performing a competitive sport
- Having metabolic disorders
- Long gut transit time (>24 h)
- Blood donor
- Irregularity in menstrual cycle (for women)
- Pregnancy (for women)
- Subject who cannot be expected to comply with the study procedures.
- Currently participating or having participated in another clinical trial during the
last 4 weeks prior to the beginning of this study.
,NULL,Sum of plasma areas under the curve of coffee phenolics,"Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids;Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-09-30,2012-01-27,2012-01-27,14,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2011,2013-06-04,TRUE,FALSE,FALSE
12915,NCT01028079,NA,NCT01028079,NCT: 2009-12-08 ICTRP: 2009-12-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no AM,NCT: Actual 338 ICTRP: 338 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2009-12-09,NA,2005-11-30,2006-12-31,Interventional,"Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain","Placebo and Active Controlled, Double Dummy Phase III Study to Prove Efficacy of Aspirin (1000 mg Solid Dose) in Treatment of Acute Low Back Pain.",Completed,Phase 3,338,Actual,Bayer,Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing,"Total pain relief 6, 72, 96 and 120 hours after first dosing;Pain intensity relief over initial 6 hours;Pain intensity difference after 48, 72, 96 and 120 hours after first dosing;Overall efficacy after 48, 72, 96 and 120 hours after first dosing;Total dose used over 5 days;Time till use of rescue medication;Safety - assessment of adverse events",11818,"Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain","Placebo and Active Controlled, Double Dummy Phase III Study to Prove Efficacy of Aspirin (1000 mg Solid Dose) in Treatment of Acute Low Back Pain.",,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 3,2009-12-08,2005-11-20,338,Completed,Bayer,NULL,germany;united kingdom;germany;united kingdom,"Drug: Acetylsalicylic Acid (Aspirin, BAYE4465);Drug: Ibuprofen;Drug: Placebo","
Inclusion Criteria:
- Ambulatory male or female, 18 to 70 years of age
- Body mass index ranging in-between 18 and 30 kg/m²
- Normal blood pressure
- Patients suffering from low back pain
- Low back pain, localized below the costal margin and above the inferior gluteal
folds, either as acute low back pain, or as chronic or intermittent low back pain
Exclusion Criteria:
- Hypersensitivity to acetylsalicylic, salicylates, or other Non Steroidal
Anti-inflammatory drugs
- Serious physical illness especially uncontrolled disorders of kidney, liver, lung,
heart or brain function, neurological disorders or severe chronic or terminal disease
- Pregnancy or lactation period
- Abuse of alcohol or addictive substances
",NULL,Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing,"Total pain relief 6, 72, 96 and 120 hours after first dosing;Pain intensity relief over initial 6 hours;Pain intensity difference after 48, 72, 96 and 120 hours after first dosing;Overall efficacy after 48, 72, 96 and 120 hours after first dosing;Total dose used over 5 days;Time till use of rescue medication;Safety - assessment of adverse events",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-11-30,2009-12-08,2009-12-08,338,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2005,2009-12-08,TRUE,FALSE,FALSE
16111,NCT00475605,NA,NCT00475605,NCT: 2007-05-17 ICTRP: 2007-05-17 DRKS: NA,1,1,NA,2,1,NA,NA,NA,NA,NA,1,NA,"unclear, time frame given",NA,NA,NA,NCT: Actual 8071 ICTRP: 8071 DRKS: NA,7954,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.jaad.2020.03.075,NA,2007-05-21,NA,2005-05-25,2019-01-31,Observational,A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis,APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis,Terminated,NA,8071,Actual,LEO Pharma,Occurrence of systemic or cutaneous malignancy,,FG506-06-37;03-0-161;EUPAS;LP0156-1294;F506-CL-5801,A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis,APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis,,,Observational,,,2007-05-17,2005-05-25,8071,Terminated,LEO Pharma,NULL,united states;austria;canada;france;germany;ireland;netherlands;poland;united kingdom;austria;canada;france;germany;ireland;netherlands;poland;united kingdom;united states,NULL,
Inclusion Criteria:
- Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age
and were treated for at least 6 weeks for the treatment of Atopic dermatitis may
enroll into the study.
,NULL,Occurrence of systemic or cutaneous malignancy,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-05-25,2007-05-17,2007-05-17,8071,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2005,2019-12-16,TRUE,FALSE,FALSE
25525,NCT01973179,DRKS00005540,DRKS00005540,NCT: NA ICTRP: 2014-08-22 DRKS: 2014-08-22,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure",3,NA,"no AM, no measure",NCT: NA ICTRP: 50 DRKS: [---]* 50,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2013-10-31,NA,2015-07-31,2023-08-31,Observational,Re-irradiation of Recurrent Head and Neck Cancer,Observational Study to Re-irradiation for Recurrent Head and Neck Cancer,Recruiting,NA,50,Anticipated,Technische Universität Dresden,late toxicity,acute toxicity;local recurrence free survival;overall survival;quality of life,STR-ReKo-2013,Re-irradiation of Recurrent Head and Neck Cancer,Observational Study to Re-irradiation for Recurrent Head and Neck Cancer,Mechthild.Krause@uniklinikum-dresden.de;Mechthild.Krause@uniklinikum-dresden.de;,Mechthild.Krause@uniklinikum-dresden.de;Mechthild.Krause@uniklinikum-dresden.de;,Observational,,,2013-10-25,2015-07-20,50,Recruiting,Technische Universität Dresden,NULL,germany,Radiation: Radiation therapy,"
Inclusion Criteria:
- tumor is located in a previously irradiated area with at least 50 Gy or there is an
overlap of radiation fields with resulting total doses greater than 90 Gy to expect
- tumor size and localization allow high dose re-irradiation (individual decision)
- exclusion of distant metastases
- Time interval between pre-irradiation and re- irradiation at least 1 year for local
recurrence; at least 6 months for secondary tumor disease
- age = 18 years
- previous radiotherapy treatment plans available
- pre-treatment imaging (pre re-irradiation) available
- good general condition (ECOG 0-1)
- dental treatment performed, if necessary
- in case of surgery before re-irradiation: resection status is R-1 or R-2
- clinical suspicion of residual tumor by very scarce surgical margins (<1 mm)
- pathological secured extracapsular extension (ECE)
- indications by an interdisciplinary tumor board
- patient able to understand the intention and procedures of the trial, written informed
consent
Exclusion Criteria:
- no description of the R- status after resection of the tumour
- pregnancy
- no written informed consent
- distant metastases
- interval between first and second irradiation < 6 months at secondary tumor or <1 year
when local recurrence of previously irradiated tumor
- simultaneous participation in another intervention study , if further treatment must
be carried out
",NULL,late toxicity,acute toxicity;local recurrence free survival;overall survival;quality of life,NCT01973179; STR-ReKo-2013,2014-08-22,yes,Head-and-neck Squamous Cell Carcinoma,Arm 1 Radiation: Radiation therapy,Non-interventional,NA,NA,NA,NA,N/A,- late toxicity; time frame: 24 months after therapy; measured from the first day of treatment
,- acute toxicity; time frame: 3 months after treatment; measured from the first day of treatment
- local recurrence free survival; time frame: 24 months after therapy; measured from the first day of treatment
- overall survival; time frame: 24 months after therapy; measured from the first day of treatment
- quality of life; time frame: 24 months after therapy; measured from the first day of treatment
,Germany,[---]* Dresden,2014-04-30,NA,50,NA,"- histologically confirmed head and neck squamous cell carcinoma
- tumor is located in a previously irradiated area with at least 50 Gy or there is an
overlap of radiation fields with resulting total doses greater than 90 Gy to expect
- tumor size and localization allow high dose re-irradiation (individual decision)
- exclusion of distant metastases
- Time interval between pre-irradiation and re- irradiation at least 1 year for local
recurrence; at least 6 months for secondary tumor disease
- age ≥ 18 years
- previous radiotherapy treatment plans available
- pre-treatment imaging (pre re-irradiation) available
- good general condition (ECOG 0-1)
- dental treatment performed, if necessary
- in case of surgery before re-irradiation: resection status is R-1 or R-2
- patient able to understand the intention and procedures of the trial, written
informed consent
","- no description of the R- status after resection of the tumour
- implanted metal in the radiation field
- pregnancy
- no written informed consent
- lack of histological confirmation
- no squamous cell carcinoma
- distant metastases
- interval between first and second irradiation < 6 months at secondary tumor or <1
year when local recurrence of previously irradiated tumor
- no previous dental treatment
- simultaneous participation in another intervention study , if further treatment must
be carried out
",Observational Study to Re-irradiation for Recurrent Head and Neck Cancer,Recruiting planned,"Technische Universität Dresden; Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden; [---]*",[---]*; [---]*; Mechthild.Krause@uniklinikum-dresden.de,Arm 1 Radiation: Radiation therapy,2015-07-31,2013-10-25,2013-10-25,50,Observational,FALSE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,TRUE,TRUE,TRUE,2015,2019-02-15,TRUE,TRUE,FALSE
17664,NCT00235976,NA,NCT00235976,NCT: 2005-10-07 ICTRP: 2005-10-07 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,3,NA,"no AM, no measure",4,NA,no AM,NCT: NA 200 ICTRP: 200 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2005-10-12,NA,2005-05-31,2006-03-31,Interventional,The Efficacy and Safety of Gantacurium Chloride for Injection in Tracheal Intubation in Healthy Adult Patients Undergoing Surgery Under General Anesthesia,"A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate the Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery With General Anesthesia",Completed,Phase 1/Phase 2,200,NA,Avera Pharmaceuticals,"The primary endpoint in this study is the graded intubation scores at 60 seconds after administration of single rapid i.v. bolus doses of study treatments (gantacurium chloride for injection, succinylcholine, or placebo)",Graded intubation scores at 120 seconds after administration of single rapid i.v. bolus doses of study treatments for those patients in whom the first intubation attempt at 60 seconds failed;Blood pressure (BP) and heart rate (HR) measurements beginning with a propofol/opioid induction-intubation sequence and ending 10 minutes after the initial intubation attempt;12-lead electrocardiograph (ECG) measurements;Number and frequency of adverse events (AEs);Clinical laboratory data;Vital sign measurements,MR/EUM202,The Efficacy and Safety of Gantacurium Chloride for Injection in Tracheal Intubation in Healthy Adult Patients Undergoing Surgery Under General Anesthesia,"A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate the Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery With General Anesthesia",;,;,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 1/Phase 2,2005-10-07,2005-05-20,200,Completed,Avera Pharmaceuticals,NULL,germany,Drug: Gantacurium Chloride for Injection (AV430A),"
Inclusion Criteria:
- Males or females between 18 and 65 years of age scheduled for low- or moderate-risk
surgical procedure requiring tracheal intubation
- Female patients must not be of child-bearing potential. Females must meet one of the
following criteria:
- Be postmenopausal;
- Have undergone prior tubal ligation or hysterectomy; or
- Be scheduled for hysterectomy as the surgical procedure for this study.
- American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2
- Weight within 30% of ideal body weight
- Able to read and to comprehend information about the study design and procedure;
willingness to participate in this study as evidenced by a signed and dated written
Informed Consent form
- In good physical and mental health as determined by the procedures/evaluations
(completed within 14 days prior to the Induction Phase [scheduled surgical
procedure])
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following
criteria are met:
- Evidence of clinically significant cardiovascular, neuromuscular, neurological,
psychiatric, renal, hepatic or pulmonary disease (including asthma), or impairment of
function (as judged by the investigator)
- Personal or family history of unusual sensitivity to NMBs or other agents used in
surgical anesthesia
- Anatomical characteristics recognized as being associated with difficult intubation
conditions, even in the presence of complete jaw and vocal cord relaxation
- History or evidence of vocal cord polyps and/or paralysis
- History or evidence of narrow angle glaucoma
- Personal or family history of malignant hyperthermia
- History of major thermal injury that required hospitalization
- Presence of genetically determined disorders of plasma cholinesterase, as determined
by medical history
- History or current evidence of abuse of any drug substance, licit or illicit
(including alcohol)
- Exposure to any of the following agents within 48 hours prior to the Induction Phase
of the study, or, if expected to be administered within the first 15 minutes after
administration of study treatment: antibiotics (except penicillins, cephalosporins,
and tetracyclines), i.v. lidocaine (except i.v. lidocaine administered in conjunction
with propofol to reduce local irritation), quinidine, trimetaphan, or dexamethasone.
- Exposure to any of the following agents within 7 days prior to the Induction Phase of
the study: tricyclic antidepressants, phenothiazines, anticonvulsants, antihistamines
(H1 - or H2 - receptor antagonists), antihypertensives, antiarrhythmics (including
procainamide), beta blockers (including propranolol, calcium channel blockers),
diuretics (including furosemide, thiazides, mannitol, and acetazolamide), potent
narcotics (including, but not limited to, oxycodone, methadone, morphine,
buprenorphine, hydromorphone), and magnesium or lithium salts. Note: weak opioids
including, but not limited to, propoxyphene, tramadol, hydrocodone, codeine,
meperidine, and tilidine are not reasons for exclusion provided no changes in daily
dosage have occurred within 3 days prior to the Induction Phase of the study.
- Exposure to monoamine oxidase inhibitors within 14 days prior to the Induction Phase
of the study.
- Exposure to anticholinesterase or cholinomimetic agents within 30 days prior to the
Induction Phase
- Previous entry into this or any other study of gantacurium chloride for injection, or
participation in any other investigational drug, biologic, or medical device study
within 30 days prior to the Induction Phase
- Pregnant (positive pregnancy test during Screening) or breastfeeding/donating breast
milk
- Any other condition that, in the opinion of the investigator, would jeopardize the
safety or rights of a subject participating in the trial or would render the subject
unable to comply with the protocol
",NULL,"The primary endpoint in this study is the graded intubation scores at 60 seconds after administration of single rapid i.v. bolus doses of study treatments (gantacurium chloride for injection, succinylcholine, or placebo)",Graded intubation scores at 120 seconds after administration of single rapid i.v. bolus doses of study treatments for those patients in whom the first intubation attempt at 60 seconds failed;Blood pressure (BP) and heart rate (HR) measurements beginning with a propofol/opioid induction-intubation sequence and ending 10 minutes after the initial intubation attempt;12-lead electrocardiograph (ECG) measurements;Number and frequency of adverse events (AEs);Clinical laboratory data;Vital sign measurements,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-05-31,2005-10-07,2005-10-07,200,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2005,2006-07-20,TRUE,FALSE,TRUE
18793,NCT00027781,NA,NCT00027781,NCT: 2001-12-07 ICTRP: 2001-12-07 DRKS: NA,0,NA,NA,2,NA,NA,NA,1,NA,NA,0,NA,"unclear what the primary outcome is, details only given in description",NA,NA,NA,NCT: Actual 37 ICTRP: 37 DRKS: NA,NA,1,NA,NA,NA,info from title,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2003-01-27,NA,2001-08-31,NA,Interventional,MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy,Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer,Completed,Phase 2,37,Actual,European Organisation for Research and Treatment of Cancer - EORTC,NA,NA,EORTC-16006-30005;MAC-07;EORTC-16006-30005,MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy,Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer,,,Interventional,Primary Purpose: Treatment,Phase 2,2001-12-07,2001-08-20,37,Completed,European Organisation for Research and Treatment of Cancer - EORTC,NULL,belgium;france;germany;israel;spain;switzerland;belgium;france;germany;israel;spain;switzerland,Drug: sabarubicin,"
DISEASE CHARACTERISTICS:
- Histologically confirmed hormone-refractory adenocarcinoma of the prostate
- Disease progression while on prior luteinizing hormone-releasing hormone (LHRH)
analogues or after orchiectomy and antiandrogens, given concurrently or consecutively
- Disease progression is defined as PSA progression documented by increases in PSA
recorded at 2 consecutive measurements over a prior reference value
- Interval of at least 1 week between the reference value and the first of these
two PSA increases
- Continued elevation of PSA for at least 6 weeks after discontinuation of
antiandrogens
- Last PSA value at least 5 ng/mL (Hybritech equivalent)
- Must have serum testosterone less than 50 ng/mL and must continue on LHRH agonist
therapy if no prior surgical castration
- No symptomatic brain or leptomeningeal metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 1.7 mg/dL
- No uncontrolled hypercalcemia
Cardiovascular:
- No history of severe heart disease
- No myocardial infarction within the past 6 months
- No cardiac insufficiency
- Normal cardiac function by MUGA scan and 12-lead EKG
Other:
- No other prior or concurrent malignancy except basal cell or squamous cell skin
cancer
- No uncontrolled systemic nonmalignant disease or infection
- No psychological, familial, or geographical conditions that would preclude compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No prior hormonal therapy except estramustine
- No concurrent estramustine
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy (e.g., for painful bone metastases)
Surgery:
- See Disease Characteristics
Other:
- No other concurrent experimental drugs or investigational therapy
",NULL,NULL,NULL,NCT00027781; EORTC-16006-30005; EORTC-16006-30005; MAC-07,2015-11-12,yes,Prostate Cancer; Malignant neoplasm of prostate,Arm 1 Drug: sabarubicin,Interventional,NA,NA,NA,NA,II,NA,NA,Belgium; France; Germany; Israel; Spain; Switzerland,[---]* Hamburg,2001-08-31,NA,37,NA,"DISEASE CHARACTERISTICS:
- Histologically confirmed hormone-refractory adenocarcinoma of the prostate
- Disease progression while on prior luteinizing hormone-releasing hormone (LHRH)
analogues or after orchiectomy and antiandrogens, given concurrently or consecutively
- Disease progression is defined as PSA progression documented by increases in PSA
recorded at 2 consecutive measurements over a prior reference value
- Interval of at least 1 week between the reference value and the first of these
two PSA increases
- Continued elevation of PSA for at least 6 weeks after discontinuation of
antiandrogens
- Last PSA value at least 5 ng/mL (Hybritech equivalent)
- Must have serum testosterone less than 50 ng/mL and must continue on LHRH agonist
therapy if no prior surgical castration
- No symptomatic brain or leptomeningeal metastatic disease
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- ALT/AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 1.7 mg/dL
- No uncontrolled hypercalcemia
Cardiovascular:
- No history of severe heart disease
- No myocardial infarction within the past 6 months
- No cardiac insufficiency
- Normal cardiac function by MUGA scan and 12-lead EKG
Other:
- No other prior or concurrent malignancy except basal cell or squamous cell skin
cancer
- No uncontrolled systemic nonmalignant disease or infection
- No psychological, familial, or geographical conditions that would preclude compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No prior hormonal therapy except estramustine
- No concurrent estramustine
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy (e.g., for painful bone metastases)
Surgery:
- See Disease Characteristics
Other:
- No other concurrent experimental drugs or investigational therapy
",NA,Open Label Phase II Study of MEN-10755 Administered Every 3 Weeks in Patients With Progressive Hormone Refractory Prostate Cancer,"Recruiting complete, follow-up complete",European Organisation for Research and Treatment of Cancer - EORTC; Universitätsklinikum Hamburg-Eppendorf; Universitätsklinikum Hamburg-Eppendorf,[---]*; [---]*; [---]*,Arm 1 Drug: sabarubicin,2001-08-31,2001-12-07,2001-12-07,37,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,2001,2012-07-23,TRUE,TRUE,FALSE
11906,NCT01194934,NA,NCT01194934,NCT: 2010-09-02 ICTRP: 2010-09-02 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",3,NA,"no AM, no measure",NCT: Actual 12 ICTRP: 12 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2010-09-03,NA,2010-08-31,2011-01-31,Interventional,NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers,"A Single Center, Open-label, Repeated Dose, Phase I Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics and the Effect on Mobilization of Hematopoietic Stem Cells of NOX-A12 Alone and in Combination With Filgrastim",Completed,Phase 1,12,Actual,NOXXON Pharma AG,To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.,"To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.;To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.",2010-020937-14;SNOXA12C101,NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers,"A Single Center, Open-label, Repeated Dose, Phase I Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics and the Effect on Mobilization of Hematopoietic Stem Cells of NOX-A12 Alone and in Combination With Filgrastim",,,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 1,2010-09-02,2010-08-20,12,Completed,NOXXON Pharma AG,NULL,germany,Drug: NOX-A12;Drug: NOX-A12;Drug: Filgrastim;Drug: NOX-A12 in combination with Filgrastim,"
Inclusion Criteria:
1. Informed consent signed by the subject.
2. Healthy male and female subjects aged 18 to 55 years of any ethnic origin.
3. Physically and mentally healthy subjects as confirmed by an interview, medical
history, clinical examination, laboratory tests and ECG. Values out of reference
range have to be assessed as not clinically significant (NCS) or clinically
significant (CS) by the investigator. Individuals presenting deviating values
assessed as not clinically significant may be included.
4. Male subjects willing to use contraceptive methods from the time of dosing until 3
months after study drug administration (such as condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository), females must
be of non-childbearing potential. Non-childbearing potential is defined as follows:
Female subjects must be surgically sterile or post-menopausal (defined as at least
two years post cessation of menses and follicular stimulating hormone = 35 mIU/mL and
serum estradiol =25 pg/mL), non-lactating and have a negative pregnancy test.
5. Body mass index between 19 and 29 kg/m2 (extremes included).
6. Body weight between 50 and 100 kg (extremes included).
7. Calculated creatinine clearance = 90 mL/min according to the Cockcroft-Gault-formula.
8. Normal lung function (FVC and FEV1 at least 80% of predicted values) at screening.
9. O2 saturation between 96% and 100% (extremes included) at screening.
10. The subject is co-operative and available for the entire study.
Exclusion Criteria:
1. Evidence in the subject's medical history or in the medical examination of any
clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,
hematological or other significant acute or chronic abnormalities which might
influence either the safety of the subject or the absorption, distribution,
metabolism or excretion of the active agent under investigation.
2. History of general malignant diseases.
3. History of renal calculus.
4. Hypersensitivity to drugs, atopic eczema, allergic bronchial asthma or any clinically
significant allergic disease (excluding non-active hayfever).
5. Hypersensitivity to the active substances or to any of its excipients.
6. Subjects having already received G-CSF in the past.
7. Intake of vitamin A derivates or retinoids within 30 days prior to the start of study
drug administration.
8. Subjects who have a significant history of sensitivity to natural sunlight or
artificial light such as ultraviolet (UV) light from sunbeds.
9. History of thrombosis or increased bleeding risk.
10. Laboratory test results outside the reference values as laid down by the study
center, which may be an evidence of disease. Positive result of HIV1/2, HCV antibody
or HBs antigen testing.
11. Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the
investigator, increases the risk of participating in the study, such as QTcB interval
>450 msec (females) and >430 msec (males), 2nd or 3rd degree atrioventricular block,
complete left bundle branch block, complete right bundle branch block or
Wolff-Parkinson-White Syndrome, defined as PR<110 msec, confirmed by a repeated ECG.
12. Subjects who have had a clinically significant illness within 8 weeks prior to the
start of study drug administration as determined by the investigator.
13. History of relevant heart disorders or evidence of hyper- or hypotension (supine
blood pressure systolic >140 mmHg or <95 mmHg or diastolic >90 mmHg or <65 mmHg at
screening).
14. Bradycardia or bradyarrhythmia (heart rate after 3 minutes supine rest <45/min at
screening).
15. Tachycardia or Tachyarrhythmia (heart rate after 3 minutes supine rest >90/min at
screening).
16. Chronic infection or acute infection or fever within the last 8 weeks prior to the
start of study drug administration as determined by the investigator.
17. Subjects who have received any prescribed systemic or topical medication within 14
days prior to dose administration as stated by the subject at screening, unless the
medication will not interfere with the study procedures or compromise safety as
assessed by an investigator in consultation with the sponsor.
18. Subjects who have received any medications (including St John's Wort) known to
chronically alter drug absorption or elimination processes within 30 days prior to
study drug administration as stated by the subject at screening, unless the
medication will not interfere with the study procedures or compromise safety as
assessed by an investigator in consultation with the sponsor.
19. Single use of any medication (including OTC) that are not expressively permitted
within two weeks prior to scheduled admission to the study (self-medication or
prescription) as stated by the subject at screening, unless the medication will not
interfere with the study procedures or compromise safety as assessed by an
investigator in consultation with the sponsor.
20. Abuse of alcohol (equivalent to more than 18 units per week, where 1 unit is
equivalent to one beer (about 330 ml) or one wine (about 150 ml) or one drink (about
40 ml)), caffeine (equivalent to more than 750 mg per day) or tobacco (equivalent to
more than 10 cigarettes a day).
21. Alcohol breath test positive at screening.
22. Drug addiction, positive drug screening in urine.
23. Participation in another clinical investigation or being in the restriction period
after a clinical investigation.
24. Blood donation of more than 100 ml or a comparable blood loss within three months
prior to study drug administration.
25. Subjects who are known or suspected (i) not to comply with the study directives, (ii)
not to be reliable or trustworthy, (iii) not to be capable of understanding and
evaluating the information given to them as part of the formal information policy
(informed consent), in particular regarding the risks and discomfort to which they
would agree to be exposed to, or (iv) to be in such a precarious financial situation
that they no longer weigh up the possible risks of their participation and the
unpleasantness they may be involved in.
26. Subjects with inadequate venous access.
27. Subjects who, in the opinion of the investigator, should not participate in the
study.
28. Subjects with an abnormal splenic size.
",NULL,To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.,"To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.;To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.",2010-020937-14; NCT01194934; 4036438,2011-06-08,no,LLT 10053943 (Hämatopoietische Stammzellmobilisierung/ Hematopoietic stem cell mobilization); LLT 10029547 (Non-Hodgkin's Lymphom / Non-Hodgkin's Lymphoma); LLT 10028233 (Multiples Myelom ohne erwähnte Remession / Multiple myeloma without mention of remission); Hodgkin's disease,"Arm 1 2.0 mg/kg NOX-A12 IV every day for 5 days; Arm 2 4.0 mg/kg NOX-A12 IV every day for 5 days; Arm 3 5 µg/kg filgrastim SC every day for 5 days
; Arm 4 Safe and efficacious dose of NOX-A12 IV in combination with filgrastim SC for 5 days. Based on PD data, a simultaneous or sequential dosing will be chosen. ",Interventional,Non-randomized controlled trial,Open (masking not used),Active control,Other,I,To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.,"To determine the pharmacokinetics of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
To quantify the mobilization of HSCs in peripheral blood after repeated doses of NOX-A12 alone, of filgrastim alone and after the combination of NOX-A12 with filgrastim.
",Germany,,2010-08-30,Actual,24,2011-01-10,"•Healthy male or female subjects aged 18-55 years of any ethnic origin.
•Body weight between 50 and 100 kg (extremes included).
•Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory parameters.
•Females of non-childbearing potential, defined as surgically sterile or post-menopausal.
•Males willing to use 2 means of contraceptive methods for at least 3 months after test substance administration.
•Normal lung function (FVC and FEV1 at least 80% of predicted values) at screening.
•Written consent to participate in the study.
","•Intake of vitamin A derivates or retinoids within 30 days prior to the start of drug administration.
•History of thrombosis.
•Chronic infection or acute infection or fever within the last 8 weeks prior to the start of drug administration.
•Subjects with a splenomegaly.
•Participation in another clinical study within three months prior to the start of drug administration.
•Blood donation (>100 ml) or a comparable blood loss within three months prior to the start of drug administration.
•Subjects who, in the investigator's opinion, may not be capable of following the study schedule for any reason.
•Subjects having already received G-CSF in the past.
","A single center, open-label, repeated dose, Phase I study in healthy subjects to assess the safety, tolerability, pharmacokinetics and the effect on mobilization of hematopoietic stem cells of NOX-A12 alone and in combination with filgrastim.","Recruiting complete, follow-up complete",NOXXON Pharma AG; NOXXON Pharma AG; Charité Research Organisation GmbH,[---]*; ffliegert@noxxon.com; andreas.hueser@charite-research.org,"Arm 1 2.0 mg/kg NOX-A12 IV every day for 5 days; Arm 2 4.0 mg/kg NOX-A12 IV every day for 5 days; Arm 3 5 µg/kg filgrastim SC every day for 5 days
; Arm 4 Safe and efficacious dose of NOX-A12 IV in combination with filgrastim SC for 5 days. Based on PD data, a simultaneous or sequential dosing will be chosen. ",2010-08-31,2010-09-02,2010-09-02,12,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2010,2014-06-25,TRUE,TRUE,FALSE
16730,NCT00388505,NA,NCT00388505,NCT: 2006-10-16 ICTRP: 2006-10-16 DRKS: NA,1,1,NA,1,1,r,definition of fibrosis; criteria more specific in register,2,1,NA,5,1,NA,5,0,not reported,NCT: Actual 517 ICTRP: 517 DRKS: NA,517,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.4187/respcare.02264,NA,2006-10-17,NA,2006-02-28,2009-03-31,Interventional,Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis,"A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects",Completed,Phase 3,517,Actual,Novartis,Number of Participants With Treatment-emergent Adverse Events,Serum Tobramycin Concentrations;Percentage of Participants With a Decrease From Baseline in Auditory Acuity;Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1);Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication;Change From Baseline in Pseudomonas Aeruginosa Sputum Density;Change From Baseline in Tobramycin Minimum Inhibitory Concentration;Antipseudomonal Antibiotic Usage During the Study;Hospitalization Due to Respiratory Events During the Study,CTBM100C2302,Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis,"A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects",;;;,;;;,Interventional,,Phase 3,2006-10-16,2006-02-20,517,Completed,Novartis Pharmaceuticals,NULL,united states;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;united states;united states;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;united states;united states;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;united states;united states;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;australia;canada;chile;colombia;france;germany;hungary;israel;italy;mexico;netherlands;spain;united kingdom;united states,Drug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for Inhalation;Drug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for Inhalation;Drug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for Inhalation;Drug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for Inhalation,"
Inclusion Criteria:
- Confirmed diagnosis of cystic fibrosis
- Male and female patients at least 6 years of age at the time of screening.
- Forced expiratory volume in one second (FEV1) at screening must be at least 25% and
less than or equal to 75% of normal predicted values for age, sex, and height based on
Knudson criteria.
- Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat
cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to
screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- Able to comply with all protocol requirements.
- Clinically stable in the opinion of the investigator.
- Use of an effective means of contraception in females of childbearing potential.
- Provide written informed consent, Health Authority Portability and Accountability Act
(HIPAA) authorization (where applicable), and assent (as appropriate) prior to the
performance of any study-related procedure.
Exclusion Criteria:
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding
Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to
screening and/or sputum culture yielding B cepacia at screening.
- Coughing up more than 60 cc of blood from the respiratory tract at any time within 30
days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Females who are pregnant (positive pregnancy test), lactating, or are planning to
become pregnant during the study.
- History of hearing loss or chronic ringing in the ears deemed clinically significant
by the investigator.
- Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study
drug administration.
- Use of loop diuretics within 7 days prior to study drug administration.
- Use of any investigational treatment within 28 days prior to study drug
administration.
- Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or
inhaled corticosteroids within 28 days prior to study drug administration (patients
may be taking these therapies at the time of enrollment, but they must have initiated
treatment more than 28 days prior to study drug administration).
Other protocol-defined inclusion/exclusion criteria may apply
;
Inclusion Criteria:
- Confirmed diagnosis of cystic fibrosis
- Male and female patients at least 6 years of age at the time of screening.
- Forced expiratory volume in one second (FEV1) at screening must be at least 25% and
less than or equal to 75% of normal predicted values for age, sex, and height based on
Knudson criteria.
- Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat
cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to
screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- Able to comply with all protocol requirements.
- Clinically stable in the opinion of the investigator.
- Use of an effective means of contraception in females of childbearing potential.
- Provide written informed consent, Health Authority Portability and Accountability Act
(HIPAA) authorization (where applicable), and assent (as appropriate) prior to the
performance of any study-related procedure.
Exclusion Criteria:
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding
Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to
screening and/or sputum culture yielding B cepacia at screening.
- Coughing up more than 60 cc of blood from the respiratory tract at any time within 30
days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Females who are pregnant (positive pregnancy test), lactating, or are planning to
become pregnant during the study.
- History of hearing loss or chronic ringing in the ears deemed clinically significant
by the investigator.
- Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study
drug administration.
- Use of loop diuretics within 7 days prior to study drug administration.
- Use of any investigational treatment within 28 days prior to study drug
administration.
- Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or
inhaled corticosteroids within 28 days prior to study drug administration (patients
may be taking these therapies at the time of enrollment, but they must have initiated
treatment more than 28 days prior to study drug administration).
Other protocol-defined inclusion/exclusion criteria may apply
;
Inclusion Criteria:
- Confirmed diagnosis of cystic fibrosis
- Male and female patients at least 6 years of age at the time of screening.
- Forced expiratory volume in one second (FEV1) at screening must be at least 25% and
less than or equal to 75% of normal predicted values for age, sex, and height based on
Knudson criteria.
- Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat
cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to
screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- Able to comply with all protocol requirements.
- Clinically stable in the opinion of the investigator.
- Use of an effective means of contraception in females of childbearing potential.
- Provide written informed consent, Health Authority Portability and Accountability Act
(HIPAA) authorization (where applicable), and assent (as appropriate) prior to the
performance of any study-related procedure.
Exclusion Criteria:
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding
Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to
screening and/or sputum culture yielding B cepacia at screening.
- Coughing up more than 60 cc of blood from the respiratory tract at any time within 30
days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Females who are pregnant (positive pregnancy test), lactating, or are planning to
become pregnant during the study.
- History of hearing loss or chronic ringing in the ears deemed clinically significant
by the investigator.
- Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study
drug administration.
- Use of loop diuretics within 7 days prior to study drug administration.
- Use of any investigational treatment within 28 days prior to study drug
administration.
- Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or
inhaled corticosteroids within 28 days prior to study drug administration (patients
may be taking these therapies at the time of enrollment, but they must have initiated
treatment more than 28 days prior to study drug administration).
Other protocol-defined inclusion/exclusion criteria may apply
;
Inclusion Criteria:
- Confirmed diagnosis of cystic fibrosis
- Male and female patients at least 6 years of age at the time of screening.
- Forced expiratory volume in one second (FEV1) at screening must be at least 25% and
less than or equal to 75% of normal predicted values for age, sex, and height based on
Knudson criteria.
- Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat
cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to
screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- Able to comply with all protocol requirements.
- Clinically stable in the opinion of the investigator.
- Use of an effective means of contraception in females of childbearing potential.
- Provide written informed consent, Health Authority Portability and Accountability Act
(HIPAA) authorization (where applicable), and assent (as appropriate) prior to the
performance of any study-related procedure.
Exclusion Criteria:
- History of sputum culture or deep-throat cough swab (or BAL) culture yielding
Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to
screening and/or sputum culture yielding B cepacia at screening.
- Coughing up more than 60 cc of blood from the respiratory tract at any time within 30
days prior to study drug administration.
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Females who are pregnant (positive pregnancy test), lactating, or are planning to
become pregnant during the study.
- History of hearing loss or chronic ringing in the ears deemed clinically significant
by the investigator.
- Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study
drug administration.
- Use of loop diuretics within 7 days prior to study drug administration.
- Use of any investigational treatment within 28 days prior to study drug
administration.
- Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or
inhaled corticosteroids within 28 days prior to study drug administration (patients
may be taking these therapies at the time of enrollment, but they must have initiated
treatment more than 28 days prior to study drug administration).
Other protocol-defined inclusion/exclusion criteria may apply
",NULL,Number of Participants With Treatment-emergent Adverse Events;Number of Participants With Treatment-emergent Adverse Events,Serum Tobramycin Concentrations;Percentage of Participants With a Decrease From Baseline in Auditory Acuity;Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1);Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication;Change From Baseline in Pseudomonas Aeruginosa Sputum Density;Change From Baseline in Tobramycin Minimum Inhibitory Concentration;Antipseudomonal Antibiotic Usage During the Study;Hospitalization Due to Respiratory Events During the Study,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-02-28,2006-10-16,2006-10-16,517,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2006,2012-06-19,TRUE,FALSE,TRUE
12699,NCT01064791,NA,NA,NCT: 2010-02-02 ICTRP: NA DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",4,NA,no AM,NCT: Actual 298 ICTRP: NA DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2010-02-08,NA,2009-12-31,2012-08-31,Interventional,"Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients","A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients",Completed,Phase 2,298,Actual,Novartis,"Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).","Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine);Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).;Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).;Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).",2009-015456-14;CAEB071A2214,"Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients","A Partially Blinded, Prospective, Randomized Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral Sotrastaurin Plus Standard or Reduced Exposure Tacrolimus vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients",;,;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 2,2010-02-02,2009-12-20,298,Completed,Novartis Pharmaceuticals,NULL,"united states;argentina;australia;belgium;brazil;canada;colombia;denmark;germany;hungary;korea, republic of;netherlands;portugal;sweden;united kingdom;argentina;australia;belgium;brazil;canada;colombia;denmark;germany;hungary;korea, republic of;netherlands;portugal;sweden;united kingdom;united states",Drug: sotrastaurin (Dose 1) + tacrolimus + standard of care medications;Drug: sotrastaurin (Dose 2) + tacrolimus + standard of care medications;Drug: sotrastaurin (Dose 3) + tacrolimus + standard of care medications;Drug: mycophenolic acid + tacrolimus + standard of care medications,"
Inclusion criteria:
- Recipients of a first or second kidney transplant from a deceased, living unrelated or
non-human leukocyte antigen (HLA) identical living related donor.
- Recipients of a kidney with a cold ischemia time < 30 hours.
- Recipients of a kidney from a donor 10 - 65 years old.
Exclusion criteria:
- Multi-organ transplant recipients.
- Recipients of an organ from an non-heart beating donor.
- Patients receiving a second kidney allograft if the first allograft was
- Functional for less than three years
- Patients who are treated with drugs that are strong inducers or inhibitors of
cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment.
Other protocol-defined inclusion/exclusion criteria may apply
",NULL,"Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).","Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine);Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up).;Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category).;Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination).",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-12-31,2010-02-02,2010-02-02,298,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2009,2020-12-15,TRUE,FALSE,TRUE
17110,NCT00325221,NA,NCT00325221,NCT: 2006-05-11 ICTRP: 2006-05-11 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 148 ICTRP: 148 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-05-12,NA,2006-08-31,2012-10-31,Interventional,Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM),"QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring",Completed,N/A,148,Actual,Biotronik SE & Co. KG,Hospital Anxiety and Depression Scale (HADS) anxiety score,Patient mobility;Frequency of contacts between patient and physician;Patient's perception of ICD therapy;HADS depression score;Quality of life (SF-12);Prevalence of Type D personality among ICD patients,HS033,Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM),"QUANTUM - Quality-of-Life, Anxiety and Depression in ICD Patients Using Home Monitoring",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",N/A,2006-05-11,2006-08-20,148,Completed,Biotronik SE & Co. KG,NULL,austria;germany;switzerland;austria;germany;switzerland,Device: HM on;Device: HM Off,"
Inclusion Criteria:
- Indication for ICD implantation either as primary or secondary prevention
- Patient informed consent
Exclusion Criteria:
- ICD replacement indication
- Indication for cardiac resynchronisation therapy
- Inability to fully understand psychosomatic questionnaires, especially cognitive
impairment or German language deficits
- Co-morbidities with a resulting life expectancy of less than one year
- Psychosomatic disease (requiring psychiatric therapy)
- Age <18 years
- Patients who are already enrolled in another study
",NULL,Hospital Anxiety and Depression Scale (HADS) anxiety score,HADS depression score;Quality of life (SF-12);Prevalence of Type D personality among ICD patients;Frequency of contacts between patient and physician;Patient's perception of ICD therapy;Patient mobility,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-08-31,2006-05-11,2006-05-11,148,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2006,2013-01-30,TRUE,FALSE,FALSE
15500,NCT00567801,NA,NCT00567801,NCT: 2007-12-04 ICTRP: 2007-12-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,5,NA,NA,2,NA,"no AM, no metric, no measure",NCT: Anticipated 250 ICTRP: 250 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-12-05,NA,2002-09-30,2010-09-30,Interventional,CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb,"Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)",Terminated,Phase 3,250,Anticipated,University Hospital Freiburg,Amputation-free survival,"Neurological status (motor function, sensor function) of ischemic limb;Systemic complications in both therapy groups;Tolerance of reperfusion solution;Lethality",S 991228,CRAIL - Controlled Reperfusion of the Acutely Ischemic Limb,"Prospektive, Randomisierte Multicenter-Studie Zur Optimierung Der Therapie Der Akuten Ischämie Der Unteren Extremitäten Durch Die Kontrollierte Extremitätenreperfusion (Prospective, Randomized Multicenter - Study for Optimization of Therapy of the Acute Ischemic Limb by Controlled Reperfusion)",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 3,2007-12-04,2002-09-20,250,Terminated,University Hospital Freiburg,"Dr. Köhler Chemie (Alsbach-Hähnlein, Germany);HP-Medica (Augsburg, Germany);GEA (Frederiksberg, Denmark);Kardialagut (München, Germany)",austria;germany;austria;germany,Procedure: conventional embolectomy/thrombectomy;Procedure: embolectomy/thrombectomy with controlled reperfusion,"
Inclusion Criteria:
- Patients aged 18 years or older
- Patients with arterial occlusion of one or both lower limbs with acute decompensated
ischemia (Rutherford IIA to III)
- Informed consent of the patient
Exclusion Criteria:
- Previous attempt of recanalisation (e.g. lysis therapy)
- Known A. poplitea aneurysm of the affected extremity
- Severe heart failure NYHA IV
- Known atrial thrombus
- Terminal renal insufficiency (creatinine >10mg/dl or current dialysis therapy,
previous transplantation of kidney)
- Hypersensitivity to allopurinol
- Hypersensitivity to one component part of the reperfusion solution
- Participation in a clinical trial during the study or 30 days before
- Pregnancy or lactation
- Patient incapable of contracting or not able to understand the character, meaning and
consequences of the clinical trial
- Abuse to drugs or alcohol
",NULL,Amputation-free survival,"Neurological status (motor function, sensor function) of ischemic limb;Systemic complications in both therapy groups;Tolerance of reperfusion solution;Lethality",NCT00567801; UKF001013,2010-10-15,yes,Embolism and thrombosis of arteries of lower extremities,Arm 1 Conventional embolectomy/thrombectomy with uncontrolled reperfusion; Arm 2 Embolectomy/thrombectomy with controlled reperfusion,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,III,survival free of amputation (after 4 weeks),"1. neurological status (motor function, sensation) of the affected limb after 4 weeks
2. frequency of systemic complications in both groups
3. tolerance of the reperfusion solution
4. mortality after 6 and 12 months",Germany; Austria,,2002-09-30,Actual,250,2009-01-13,- patients > 18 years of age
- arterial occlusion in one or both of the lower extremities concurrent with acute ischemia causing decompensation ( Rutherford Stage IIA-III),"- patients who have undergone a recent, or current attempt to revascularize (for example: lysis therapy)
- patients with a known A. poplitea aneurysma in the limb concerned
- patients with severe heart failure (NYHA IV)
- patients with terminal kidney failure (creatinine > 10mg/dl) or undergoing dialysis, kidney transplant
- allopurinol intolerance
- allergy to any of the components in the reperfusion solution
- current participation in a clinical trial (or within the last 30 days)
- pregnant patients, or those currently breastfeeding
- other conditions or circumstances likely to lead to poor treatment adherence (i.e., drug dependency, no fixed abode)",CRAIL-study: Prospektive randomized multicenter study for optimization of therapy of the acute ischemic limb by controlled reperfusion.,Recruiting stopped after recruiting started ,Universitätsklinikum Freiburg; Universitäts-Herzzentrum Freiburg-Bad Krozingen Klinik für Herz- und Gefäßchirurgie; Universitaets-Herzzentrum Freiburg - Bad Krozingen Klinik für Herz- und Gefaesschirurgie,[---]*; friedhelm.beyersdorf@universitaets-herzzentrum.de; friedhelm.beyersdorf@universitaets-herzzentrum.de,Arm 1 Conventional embolectomy/thrombectomy with uncontrolled reperfusion; Arm 2 Embolectomy/thrombectomy with controlled reperfusion,2002-09-30,2007-12-04,2007-12-04,250,Interventional,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2002,2008-07-25,TRUE,TRUE,FALSE
7346,NCT01988259,NA,NCT01988259,NCT: 2013-11-13 ICTRP: 2013-11-13 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,"no AM, no metric",NA,NA,NA,NCT: Anticipated 100 ICTRP: 100 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2013-11-20,NA,2013-09-30,NA,Interventional,Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine,Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis,Unknown status,N/A,100,Anticipated,Schoen Klinik Hamburg Eilbek,Performance of head-neck-coordination after surgery of the dorsal cervical spine,,MISDCS,Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine,Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis,;rkothe@Schoen-Kliniken.de;rkothe@Schoen-Kliniken.de,;rkothe@Schoen-Kliniken.de;rkothe@Schoen-Kliniken.de,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",N/A,2013-11-13,2013-09-20,100,Recruiting,Schoen Klinik Hamburg Eilbek,Jacek Cholewicki PhD;MSU Center for Orthopedic Research,germany,Procedure: Bilateral approach for Laminoplasty;Procedure: Unilateral approach for laminoplasty;Procedure: Subperiosteal approach for foraminotomy;Procedure: Transmuscular approach for foraminotomy,
Inclusion Criteria:
- radicular or myelopathic compression syndrome in the cervical spine
Exclusion Criteria:
- neurological diseases with influence on the neuromuscular function
- previous surgery on the cervical spine
,NULL,Performance of head-neck-coordination after surgery of the dorsal cervical spine,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-09-30,2013-11-13,2013-11-13,100,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2013,2015-05-21,TRUE,FALSE,FALSE
12140,NCT01154881,NA,NCT01154881,NCT: 2010-06-30 ICTRP: 2010-06-30 DRKS: NA,1,1,NA,1,1,a,criteria more specific in article,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 49 ICTRP: 49 DRKS: NA,49,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1111/j.1463-1326.2012.01638.x,NA,2010-07-01,NA,2010-06-30,2010-11-30,Interventional,A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes,A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State in Subjects With Type 2 Diabetes,Completed,Phase 1,49,Actual,Novo Nordisk A/S,Area under the glucose infusion rate curve from 0-24 hours at steady state,Area under the insulin degludec concentration-time curve from 0-24 hours at steady state,U1111-1114-9099;2009-017281-23;NN1250-1987,A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes,A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State in Subjects With Type 2 Diabetes,;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 1,2010-06-30,2010-06-20,49,Completed,Novo Nordisk A/S,NULL,germany;germany;germany;germany;germany,Drug: insulin degludec;Drug: insulin degludec;Drug: insulin degludec;Drug: insulin degludec,
Inclusion Criteria:
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m2
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
;
Inclusion Criteria:
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m2
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
;
Inclusion Criteria:
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m2
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
;
Inclusion Criteria:
- Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index (BMI) below or equal to 35.0 kg/m2
Exclusion Criteria:
- Subject who has donated any blood or plasma in the past month or more than 500 mL
within 3 months prior to screening
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent
per day)
- Not able or willing to refrain from smoking and use of nicotine gum or transdermal
nicotine patches during the inpatient period
,NULL,Area under the glucose infusion rate curve from 0-24 hours at steady state;Area under the glucose infusion rate curve from 0-24 hours at steady state;Area under the glucose infusion rate curve from 0-24 hours at steady state,Area under the insulin degludec concentration-time curve from 0-24 hours at steady state,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-06-30,2010-06-30,2010-06-30,49,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2010,2017-01-19,TRUE,FALSE,FALSE
13060,NCT01001468,NA,NCT01001468,NCT: 2009-10-20 ICTRP: 2009-10-20 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Actual 185 ICTRP: 185 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2009-10-26,NA,2009-12-31,2011-07-31,Interventional,Study to Assess VB-201 in Patients With Psoriasis,"A Randomized, Double-Blind, 12-Week, Dose-Ranging Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis",Completed,Phase 2,185,Actual,Vascular Biogenics Ltd. operating as VBL Therapeutics,Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12,Change in PGA (Physician Global Assessment) scores from baseline to Week 12;Change in Patient Psoriasis Global Assessment scores from baseline to Week 12;Change in affected Body Surface Area (BSA) from baseline to Week 12;Measurement of improvement in the PASI (50) from baseline at Week 12,VB-201-006,Study to Assess VB-201 in Patients With Psoriasis,"A Randomized, Double-Blind, 12-Week, Dose-Ranging Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis",NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2,2009-10-20,2009-12-20,185,Completed,Vascular Biogenics Ltd. operating as VBL Therapeutics,NULL,united states;germany;israel;united states;germany;israel,Drug: VB-201;Drug: VB-201;Other: Placebo,"
Inclusion Criteria:
- Male or female Patients, =18 to =75 years of age, who have a diagnosis of chronic
plaque psoriasis for at least 6 months
- Non-anorexic subjects with a BMI =20
- Psoriasis Area and Severity Index (PASI) score of =12
- Plaque psoriasis covering =10% of body surface area (BSA)
- Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point
Physician Global Assessment (PGA) scale
Exclusion Criteria:
- The subject presents with the predominant type of psoriasis as guttate,
erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis
- The subject has not undergone wash-out periods of sufficient duration for the
following treatments at Baseline: Topical psoriasis treatments; Systemic, oral or
injected, psoriasis treatments; Phototherapy
- The subject anticipates getting enough ultra-violet light during the study to cause
psoriasis to improve
- The subject has a known allergy or sensitivity to the study treatment(s) or to any of
the excipients contained in the study drug formulation
- History of cancer, the exception is skin cancer
- Has a clinically significant systemic infection within 30 days of Day 0, or a history
or presence of recurrent or chronic infection
- Evidence of tuberculosis as indicated by a positive tuberculin skin test or a
quantiferon test in subjects known to have a + PPD and a negative chest x-ray at
screening
- History of clinically significant hypoglycemia
- Subjects with currently active peptic ulcer / gastroesophageal reflux disease
",NULL,Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12,Change in PGA (Physician Global Assessment) scores from baseline to Week 12;Change in Patient Psoriasis Global Assessment scores from baseline to Week 12;Change in affected Body Surface Area (BSA) from baseline to Week 12;Measurement of improvement in the PASI (50) from baseline at Week 12,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-12-31,2009-10-20,2009-10-20,185,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2009,2011-11-15,TRUE,FALSE,TRUE
16281,NCT00447486,NA,NCT00447486,NCT: 2007-03-12 ICTRP: 2007-03-12 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,info from title,4,NA,no AM,3,NA,"no AM, no metric",NCT: Actual 308 ICTRP: 308 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,Review,https://doi.org/10.1016/j.bone.2011.10.008,NA,2007-03-14,NA,2007-04-30,NA,Interventional,A Study of GW842166 in Adults With Osteoarthritis Pain,"A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee",Completed,Phase 2,308,Actual,GlaxoSmithKline,The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline,"WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments",CBA109389,A Study of GW842166 in Adults With Osteoarthritis Pain,"A Multicentre, Randomised, Double-Blind, Placebo and Naproxen (500mg) BID Controlled, Phase II Proof of Concept, Parallel Group Study to Assess the Efficacy and Safety of Oral GW842166 at Two Dose Levels Administered for 4 Weeks in Adults With Osteoarthritis of the Knee",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 2,2007-03-12,2007-04-20,308,Completed,GlaxoSmithKline,NULL,denmark;germany;spain;sweden;denmark;germany;spain;sweden,Drug: GW842166,"
Inclusion Criteria:
- male or female outpatient, >= 40 years of age
- meets ACR clinical and radiographic criteria for classification of idiopathic
(primary) osteoarthritis of the knee with symptom duration for at least 3 months
- meets ARA functional status requirements
- meets WOMAC pain subscale score requirements
- has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days
in each of the 4 weeks preceding screen
Exclusion Criteria:
- any pre-specified clinical/biological/ECG abnormality
- any pre-specified drug sensitivity
- history of peptic ulceration or GI bleeding
- use of protocol-specified medications
- secondary cause of knee OA
- lower extremity surgery within 6 months of screening
- use of analgesics other than allowed per protocol
- use of corticosteroids or hyaluronan outside of allowed window prior to screening
",NULL,The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline,"WOMAC pain subscale, stiffness, physical function scores and patient and physician global assessments",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-04-30,2007-03-12,2007-03-12,308,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,2009-05-15,TRUE,FALSE,TRUE
8490,NCT01760525,NA,NCT01760525,NCT: 2013-01-02 ICTRP: 2013-01-02 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,dosing scheme from description,5,NA,NA,5,NA,NA,NCT: Actual 51 ICTRP: 51 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2013-01-04,NA,2013-03-20,2020-07-24,Interventional,A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors,"A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced Solid Tumors",Completed,Phase 1,51,Actual,Novartis,Incidence of Dose Limiting Toxicities,"Pharmacokinetic profile of CGM097;Tumor response per RECIST;Pharmacodynamic effect of CGM097;Changes in laboratory values, vital signs or cardiac functionality, dose reduction, dose interruption and dose intensity, incidence and severity of adverse events.",2012-000940-87;CCGM097X2101,A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors,"A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced Solid Tumors",,,Interventional,Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1,2013-01-02,2013-03-20,51,Completed,Novartis Pharmaceuticals,NULL,united states;france;germany;singapore;switzerland;france;germany;singapore;switzerland;united states,Drug: CGM097,"
Inclusion Criteria:
- Patient has advanced solid malignancy that has progressed despite standard therapy, or
for which no effective standard therapy exists
- Tumor of the patient is p53wt
- Evaluable disease as determined by RECIST 1.1
- WHO performance status 0-2
Exclusion criteria:
- Prior treatment with CGM097 or other p53/HDM2-interaction inhibitor
- Patient with symptomatic or growing CNS metastatic lesions
- Concurrent other malignancy
- Clinically significant cardiac disease as defined in the protocol
- Diagnosis of acute or chronic pancreatitis
- Concomitant therapy that precludes enrollment, as defined in the protocol
- Women of child-bearing potential, unless they are using highly effective methods of
contraception during dosing and for 2 weeks after study drug discontinuation
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply.
",NULL,Incidence of Dose Limiting Toxicities,"Pharmacokinetic profile of CGM097;Tumor response per RECIST;Pharmacodynamic effect of CGM097;Changes in laboratory values, vital signs or cardiac functionality, dose reduction, dose interruption and dose intensity, incidence and severity of adverse events.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-03-20,2013-01-02,2013-01-02,51,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,2020-11-02,TRUE,FALSE,FALSE
13428,NCT00939042,NA,NCT00939042,NCT: 2009-07-13 ICTRP: 2009-07-13 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,2,NA,NA,2,NA,NA,NCT: Actual 40 ICTRP: 40 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2009-07-14,NA,2009-01-31,2014-01-31,Interventional,Alster Stem Cells - Intramyocardial Stem Therapy,Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells,Terminated,N/A,40,Actual,Asklepios proresearch,Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).,"Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.;Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.",2008-004625-42;1777,Alster Stem Cells - Intramyocardial Stem Therapy,Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells,,,Interventional,Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2009-07-13,2009-01-20,40,Terminated,Asklepios proresearch,NULL,germany,Procedure: Percutaneous Coronary Intervention;Procedure: BMNC therapy,
Inclusion Criteria:
- LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
- conventional therapy according to the ESC guidelines for heart failure
- BMI > 20 and < 35
Exclusion Criteria:
- PCI elder then 21 days
- relevant valvular disease
- history of stroke/multivessel disease/thromboembolic event etc.
- DM Type I
- pregancy
,NULL,Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).,"Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.;Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-01-31,2009-07-13,2009-07-13,40,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2009,2018-04-05,TRUE,FALSE,TRUE
5978,NCT02284009,NA,NCT02284009,NCT: 2014-09-18 ICTRP: 2014-09-18 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,5,1,"No intermediate time frames reported, only the last one",NCT: Actual 67 ICTRP: 67 DRKS: NA,67,1,1,2,1,NA,"Double (Participant, Investigator)",Double,ok,0,no outcome,ganzer Artikel,https://doi.org/10.1210/clinem/dgaa149,NA,2014-11-05,NA,2014-10-10,2017-10-18,Interventional,Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus,Study 110933: Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus,Completed,Phase 2,67,Actual,GlaxoSmithKline,Mean Change From Baseline in Time Normalized Stimulated (From Mixed Meal Tolerance Test [MMTT]) 2-hour Plasma C-peptide Area Under the Curve (AUC) at Week 52,"Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64;Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64;Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64;Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64;Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64;Change From Baseline in Percent HbA1c at Week 52;Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64);Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64;Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52;Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52;Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Change From Baseline in Body Weight (Kilograms) at Week 52;Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64);Population Estimates of Pharmacokinetic (PK) Parameters: Apparent Clearance [CL/F];Population Estimates of PK Parameters: Apparent Volume of Distribution [V/F];Population Estimates of PK Parameters: First-order Absorption Rate Constant [Ka]",110933,Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus,Study 110933: Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus,,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2014-09-18,2014-10-10,67,Completed,GlaxoSmithKline,NULL,france;germany;italy;spain;united kingdom;france;germany;italy;spain;united kingdom,Biological: Albiglutide weekly injection;Biological: Placebo weekly injection;Biological: Insulin,"
Inclusion Criteria:
- Male or female, aged 18 to 30 years, inclusive, with a diagnosis of T1DM with an
interval of 28-56 days between the initial diagnosis and the first dose of study drug.
Documentation of the diagnosis of T1DM (and not just insulin deficiency), including
the date of diagnosis, must be obtained from the diagnosing physician.
- Currently requires insulin for T1DM treatment, or has required insulin therapy for
T1DM (for >=7 days) between the date of diagnosis and the first dose of study drug.
Note: subjects currently taking twice daily commercially available pre-mixed insulin
will not be eligible.
- Positive for at least one of the following autoantibodies typically associated with
T1DM: antibody to glutamic acid decarboxylase (anti-GAD) antibody to protein tyrosine
phosphatase-like protein (anti-IA-2) or an insulin autoantibody (IAA). Please note: A
subject who is positive for IAA and negative for the other autoantibodies will not be
eligible if the subject has been using insulin for a total of >=7days.
- Evidence of residual functioning pancreatic beta-cells as measured by a peak
stimulated C-peptide level > 0.20 nanomoles/litres (nmol/L) during the Screening MMTT
when plasma glucose level is >3.9 mmol/L (70 mg/dL) and <=11.1 mmol/L (200 mg/dL).
Note: the Screening MMTT should not be performed within one week of resolution of a
DKA event.
- Body mass index <=32.0 kilogram/square meters (kg/m^2).
- Female subjects of childbearing potential (i.e., not surgically sterile and/or not
postmenopausal) must be practicing adequate contraception (i.e., meeting one of the
criteria defined below) from at least 14 days prior to the first dose of randomised
study medication until the 12-week post-treatment Follow-up visit : Abstinence from
penile-vaginal intercourse, when this is the female's preferred and usual lifestyle;
Oral Contraceptive, either combined or progestogen alone ; Injectable progestogen;
Implants of etonogestrel or levonorgestrel; Estrogenic vaginal ring; Percutaneous
contraceptive patches; Intrauterine device or intrauterine system that has a failure
rate of less than 1% per year when used consistently and correctly as stated in the
product label; Male partner sterilization prior to the female subject's entry into the
study, and this male is the sole partner for that subject. The information on the male
sterility can come from the site personnel's review of subject's medical records;
medical examination of the subject and/or semen analysis; or interview with the
subject on his medical history.; Male condom combined with a female diaphragm, either
with or without a vaginal spermicide
- Able and willing to provide written informed consent and to comply with all study
procedures.
Exclusion Criteria:
- Severe gastroparesis i.e., requiring therapy within 6 months prior to Screening
- History of acute or chronic pancreatitis, or considered clinically at significant risk
of developing pancreatitis, during the course of the study (e.g. due to symptomatic
gallstones, excess alcohol use).
- History of significant gastrointestinal surgery that in the opinion of the
investigator is likely to significantly affect upper gastrointestinal or pancreatic
function (e.g. gastric bypass and banding, antrectomy, Roux-en-Y bypass, gastric
vagotomy, small bowel resection, or surgeries thought to significantly affect upper
gastrointestinal function)
- Personal history or family history of thyroid medullary carcinoma or multiple
endocrine neoplasia type 2 (MEN2)
- History of cancer that has not been in full remission for at least 3 years before
Screening. (A history of squamous cell or basal cell carcinoma of the skin, or treated
cervical intraepithelial neoplasia I or cervical intraepithelial neoplasia II is
allowed)
- Fasting triglyceride level >750 milligram/decilitre (mg/dL) at Screening. Subjects may
be re-tested once during screening, and if the value no longer meets the exclusion
criterion, the subject can be randomly assigned to treatment
- Estimated Glomerular Filtration Rate (eGFR) <=30 mL/min/1.73 m^2 (calculated using the
Modification of Diet in Renal Disease (MDRD) formula
- Haemoglobinopathy that may affect proper interpretation of HbA1c
- Alanine aminotransferase (ALT) >2.5 × upper limit of normal (ULN) and bilirubin >1.5 ×
ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and
direct bilirubin <35%)
- Unstable liver disease (as defined by the presence of ascites, encephalopathy,
coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice),
cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or
asymptomatic gallstones). [Chronic stable hepatitis B and C are acceptable if subject
otherwise meets entry criteria and are not on active antiviral treatment (e.g.,
presence of hepatitis B surface antigen or positive hepatitis C test result within 3
months of screening)]
- Any clinically significant co-morbidity or abnormality (including psychiatric
disorder, any other autoimmune endocrinopathy e.g., primary autoimmune hypothyroidism,
hyperadrenalism, coeliac disease etc) that in the opinion of the Investigator, may
pose additional risk in administering study medication or trial participation
- Female subject is pregnant (confirmed by laboratory testing) or lactating
- Known allergy to any GLP-1 analogue, insulin, or excipients of albiglutide
- Treatment with any oral anti-diabetic medication within the prior 30 days or 5 half
lives of that medication, whichever is longer.
- Use of immunosuppressants, intravenous immunoglobulin, oral or systemically injected
glucocorticoids within the 3 months before randomisation or high likelihood of a
requirement for prolonged treatment (>1 week) in the year following randomisation.
However, short courses of oral steroids (single dose or multiple doses for up to 7
days) may be permitted provided these cases are discussed with the medical monitor.
Inhaled, intra-articular, and small quantities of non-potent topical corticosteroids
are allowed
- Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is
longer, before Screening, a history of receipt of an investigational anti-diabetic
drug within the 3 months before randomisation, or receipt of albiglutide in previous
studies.
",NULL,Mean Change From Baseline in Time Normalized Stimulated (From Mixed Meal Tolerance Test [MMTT]) 2-hour Plasma C-peptide Area Under the Curve (AUC) at Week 52,"Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64;Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64;Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64;Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64;Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64;Change From Baseline in Percent HbA1c at Week 52;Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64);Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64;Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52;Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52;Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52;Change From Baseline in Body Weight (Kilograms) at Week 52;Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64);Population Estimates of Pharmacokinetic (PK) Parameters: Apparent Clearance [CL/F];Population Estimates of PK Parameters: Apparent Volume of Distribution [V/F];Population Estimates of PK Parameters: First-order Absorption Rate Constant [Ka]",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-10-10,2014-09-18,2014-09-18,67,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2014,2020-06-12,TRUE,FALSE,TRUE
11151,NCT01308580,DRKS00006520,DRKS00006520,NCT: 2011-03-03 ICTRP: 2015-03-11 DRKS: 2015-03-11,1,1,NA,2,1,NA,NA,2,1,NA,5,1,NA,5,1,NA,NCT: Actual 1200 ICTRP: 1200 DRKS: [---]* 1200,1200,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1200/jco.2016.72.1076,NA,2011-03-04,NA,2011-04-30,2015-08-31,Interventional,Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer,"Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen",Completed,Phase 3,1200,Actual,Sanofi,Overall Survival (OS),Progression Free Survival (PFS);Time to Tumor Progression;Percentage of Participants With Overall Objective Tumor Response;Time to PSA Progression;Percentage of Participants With PSA Response;Time to Pain Progression;Percentage of Participants With Pain Response;Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL);Change From Baseline in FACT-P:Total Score as a Measure of HRQoL;Percentage of Participants With FACT-P Total Score Response;Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales;Time to Definitive Deterioration of ECOG PS Score From Baseline;Time to Definitive Weight Loss by 5% and 10% From Baseline;Time to First Definitive Consumption of Narcotic Medication;Percentage of Participants With Treatment-emergent Adverse Events (TEAEs);Plasma Clearance (CL) for Cabazitaxel;Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel,2010-022163-35;EFC11785,Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer,"Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen",;;;;,;;;;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2011-03-03,2011-04-20,1200,Completed,Sanofi,NULL,"united states;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;united states;united states;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;united states;united states;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;united states;united states;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;united states;united states;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;argentina;australia;belgium;brazil;canada;chile;france;germany;hungary;korea, republic of;netherlands;peru;poland;romania;russian federation;south africa;spain;taiwan;tunisia;turkey;united kingdom;united states",Drug: Cabazitaxel (XRP6258);Drug: Prednisone (or Prednisolone);Drug: Cabazitaxel (XRP6258);Drug: Prednisone (or Prednisolone);Drug: Cabazitaxel (XRP6258);Drug: Prednisone (or Prednisolone);Drug: Cabazitaxel (XRP6258);Drug: Prednisone (or Prednisolone),"
Inclusion criteria :
I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was
resistant to hormone therapy and previously treated with a docetaxel-containing regimen.
I 02. Participant must had either measurable or non-measurable disease. I 03. Received
prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH)
agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with
estramustine, or other hormonal agents.
I 04. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG)
performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all
self-care, and up and about more than 50% of waking hours).
I 06. Age =18 years (or country's legal age of majority if the legal age was > 18 years).
Exclusion criteria:
E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or
radiotherapy to =30% of bone marrow. In case of prior isotope therapy 12 weeks must had
elapsed prior to first study drug administration.
E 03. Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.
E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which
chemotherapy had been completed = 5 years ago and from which the participant had been
disease-free for = 5 years.
E 06. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.
E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or
medical conditions. E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or
hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction
within last 6 months was also not allowed.
E 10. Any severe acute or chronic medical condition which could impair the ability of the
participant to participate to the study or to comply with the study procedures or interfere
with interpretation of study results.
E 11. Absence of signed and dated Institutional Review Board (IRB)-approved participant
informed consent form prior to enrollment into the study.
E 12. Participants with reproductive potential who did not agree to use accepted and
effective method of contraception during the study treatment period. The definition of
effective method of contraception was based on the Investigator's judgment. Participant's
Partners of childbearing potential (unless surgically sterile, post menopausal or for
another reason had no chance of becoming pregnant) not protected by highly effective
contraceptive method of birth control as defined for contraception in the Informed Consent
Form and /or in a local protocol addendum.
E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ
and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E
16. Symptomatic peripheral neuropathy grade > 2 (NCI CTCAE v.4.03).
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
;
Inclusion criteria :
I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was
resistant to hormone therapy and previously treated with a docetaxel-containing regimen.
I 02. Participant must had either measurable or non-measurable disease. I 03. Received
prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH)
agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with
estramustine, or other hormonal agents.
I 04. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG)
performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all
self-care, and up and about more than 50% of waking hours).
I 06. Age =18 years (or country's legal age of majority if the legal age was > 18 years).
Exclusion criteria:
E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or
radiotherapy to =30% of bone marrow. In case of prior isotope therapy 12 weeks must had
elapsed prior to first study drug administration.
E 03. Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.
E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which
chemotherapy had been completed = 5 years ago and from which the participant had been
disease-free for = 5 years.
E 06. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.
E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or
medical conditions. E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or
hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction
within last 6 months was also not allowed.
E 10. Any severe acute or chronic medical condition which could impair the ability of the
participant to participate to the study or to comply with the study procedures or interfere
with interpretation of study results.
E 11. Absence of signed and dated Institutional Review Board (IRB)-approved participant
informed consent form prior to enrollment into the study.
E 12. Participants with reproductive potential who did not agree to use accepted and
effective method of contraception during the study treatment period. The definition of
effective method of contraception was based on the Investigator's judgment. Participant's
Partners of childbearing potential (unless surgically sterile, post menopausal or for
another reason had no chance of becoming pregnant) not protected by highly effective
contraceptive method of birth control as defined for contraception in the Informed Consent
Form and /or in a local protocol addendum.
E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ
and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E
16. Symptomatic peripheral neuropathy grade > 2 (NCI CTCAE v.4.03).
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
;
Inclusion criteria :
I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was
resistant to hormone therapy and previously treated with a docetaxel-containing regimen.
I 02. Participant must had either measurable or non-measurable disease. I 03. Received
prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH)
agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with
estramustine, or other hormonal agents.
I 04. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG)
performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all
self-care, and up and about more than 50% of waking hours).
I 06. Age =18 years (or country's legal age of majority if the legal age was > 18 years).
Exclusion criteria:
E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or
radiotherapy to =30% of bone marrow. In case of prior isotope therapy 12 weeks must had
elapsed prior to first study drug administration.
E 03. Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.
E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which
chemotherapy had been completed = 5 years ago and from which the participant had been
disease-free for = 5 years.
E 06. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.
E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or
medical conditions. E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or
hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction
within last 6 months was also not allowed.
E 10. Any severe acute or chronic medical condition which could impair the ability of the
participant to participate to the study or to comply with the study procedures or interfere
with interpretation of study results.
E 11. Absence of signed and dated Institutional Review Board (IRB)-approved participant
informed consent form prior to enrollment into the study.
E 12. Participants with reproductive potential who did not agree to use accepted and
effective method of contraception during the study treatment period. The definition of
effective method of contraception was based on the Investigator's judgment. Participant's
Partners of childbearing potential (unless surgically sterile, post menopausal or for
another reason had no chance of becoming pregnant) not protected by highly effective
contraceptive method of birth control as defined for contraception in the Informed Consent
Form and /or in a local protocol addendum.
E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ
and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E
16. Symptomatic peripheral neuropathy grade > 2 (NCI CTCAE v.4.03).
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
;
Inclusion criteria :
I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that was
resistant to hormone therapy and previously treated with a docetaxel-containing regimen.
I 02. Participant must had either measurable or non-measurable disease. I 03. Received
prior castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH)
agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with
estramustine, or other hormonal agents.
I 04. Life expectancy > 6 months. I 05. Eastern Cooperative Oncology Group (ECOG)
performance status (PS) 0 - 2 (i.e, participant must be ambulatory, capable of all
self-care, and up and about more than 50% of waking hours).
I 06. Age =18 years (or country's legal age of majority if the legal age was > 18 years).
Exclusion criteria:
E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or
radiotherapy to =30% of bone marrow. In case of prior isotope therapy 12 weeks must had
elapsed prior to first study drug administration.
E 03. Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.
E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer were allowed, as well as any other cancer for which
chemotherapy had been completed = 5 years ago and from which the participant had been
disease-free for = 5 years.
E 06. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.
E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or
medical conditions. E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or
hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction
within last 6 months was also not allowed.
E 10. Any severe acute or chronic medical condition which could impair the ability of the
participant to participate to the study or to comply with the study procedures or interfere
with interpretation of study results.
E 11. Absence of signed and dated Institutional Review Board (IRB)-approved participant
informed consent form prior to enrollment into the study.
E 12. Participants with reproductive potential who did not agree to use accepted and
effective method of contraception during the study treatment period. The definition of
effective method of contraception was based on the Investigator's judgment. Participant's
Partners of childbearing potential (unless surgically sterile, post menopausal or for
another reason had no chance of becoming pregnant) not protected by highly effective
contraceptive method of birth control as defined for contraception in the Informed Consent
Form and /or in a local protocol addendum.
E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ
and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment. E
16. Symptomatic peripheral neuropathy grade > 2 (NCI CTCAE v.4.03).
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
",NULL,Overall Survival (OS);Overall Survival (OS);Overall Survival (OS),Plasma Steady State Volume of Distribution (Vss) for Cabazitaxel;Plasma Clearance (CL) for Cabazitaxel;Percentage of Participants With Treatment-emergent Adverse Events (TEAEs);Time to First Definitive Consumption of Narcotic Medication;Time to Definitive Weight Loss by 5% and 10% From Baseline;Time to Definitive Deterioration of ECOG PS Score From Baseline;Time to Definitive Deterioration of Score by 10% From Baseline on FACT-P Sub-Scales;Percentage of Participants With FACT-P Total Score Response;Change From Baseline in FACT-P:Total Score as a Measure of HRQoL;Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of Health Related Quality of Life (HRQoL);Percentage of Participants With Pain Response;Time to Pain Progression;Percentage of Participants With PSA Response;Time to PSA Progression;Percentage of Participants With Overall Objective Tumor Response;Time to Tumor Progression;Progression Free Survival (PFS),2010-022163-35; NCT01308580; EFC11785; 2010-022163-35,2015-03-11,no,Prostate Cancer; Malignant neoplasm of prostate,Arm 1 Drug: Cabazitaxel (XRP6258); Arm 2 Drug: Prednisone,Interventional,Randomized controlled trial,Open (masking not used),NA,Parallel,III,- Overall survival; time frame: up to 6 years
,- Progression Free Survival (PFS); time frame: up to 6 years
,"United States; Argentina; Australia; Belgium; Brazil; Canada; Chile; France; Germany; Hungary; Korea, Republic of; Netherlands; Peru; Poland; Romania; Russian Federation; South Africa; Spain; Taiwan, Province of China; Tunisia",[---]* Aachen; [---]* Dresden; [---]* Düsseldorf; [---]* Erlangen; [---]* Hamburg; [---]* Hamburg; [---]* Homburg; [---]* München; [---]* Nürtingen; [---]* Tübingen; [---]* Wuppertal,2011-04-30,NA,1200,2015-08-01,"Inclusion criteria :
I 01. Diagnosis of histologically or cytologically proven prostate adenocarcinoma, that is
resistant to hormone therapy and previously treated with a docetaxel-containing regimen.
I 02. Patient must have either measurable or non-measurable disease. I 03. Received prior
castration by orchiectomy and/or Luteinizing Hormone-Releasing Hormone (LH-RH) agonist
with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or
other hormonal agents.
I 04. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2 (ie, patient
must be ambulatory, capable of all self-care, and up and about more than 50% of waking
hours).
I 05. Age ≥18 years (or country's legal age of majority if the legal age is > 18 years).
Exclusion criteria:
E 01. Previous treatment with mitoxantrone or cabazitaxel. E 02. Prior isotope therapy or
radiotherapy to ≥30% of bone marrow. In case of prior isotope therapy 12 weeks must have
elapsed prior to first study drug administration.
E 03. Adverse events (excluding alopecia and those listed in the specific exclusion
criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v4.03) at the time of randomization.
E 04. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks
prior to enrollment in the study.
E 05. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial
(pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which
chemotherapy has been completed ≥ 5 years ago and from which the patient has been
disease-free for ≥ 5 years.
E 06. Participation in another clinical trial and any concurrent treatment with any
investigational drug within 30 days prior to randomization.
E 07. Known brain or leptomeningeal involvement. E 08. Other concurrent serious illness or
medical conditions E 09. Uncontrolled cardiac arrhythmias, angina pectoris, and/or
hypertension. History of congestive heart failure (NYHA III or IV) or myocardial
infarction within last 6 months is also not allowed.
E 10. Any severe acute or chronic medical condition which could impair the ability of the
patient to participate to the study or to comply with the study procedures or interfere
with interpretation of study results.
E 11. Absence of signed and dated Institutional Review Board (IRB)-approved patient
informed consent form prior to enrollment into the study.
E 12. Patients with reproductive potential who do not agree to use accepted and effective
method of contraception during the study treatment period. The definition of ""effective
method of contraception"" will be based on the Investigator's judgment. Patients' Partners
of childbearing potential (unless surgically sterile, post menopausal or for another
reason have no chance of becoming pregnant) not protected by highly effective
contraceptive method of birth control as defined for contraception in the Informed Consent
Form and /or in a local protocol addendum.
E 13. History of hypersensitivity to docetaxel, or polysorbate 80. E 14. Inadequate organ
and bone marrow function. E 15. Contraindications to the use of corticosteroid treatment.
E 16. Symptomatic peripheral neuropathy grade > 2 (National Cancer Institute Common
Terminology Criteria [NCI CTCAE] v.4.03).
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
",NA,"Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen","Recruiting complete, follow-up complete",Sanofi; Sanofi; Sanofi,[---]*; [---]*; [---]*,Arm 1 Drug: Cabazitaxel (XRP6258); Arm 2 Drug: Prednisone,2011-04-30,2011-03-03,2011-03-03,1200,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2011,2017-03-16,TRUE,TRUE,TRUE
8492,NCT01760083,NA,NCT01760083,NCT: 2013-01-01 ICTRP: 2013-01-01 DRKS: NA,1,1,NA,2,0,NA,CTO location 12 missing in article,2,1,NA,4,1,no AM,4,1,no AM,NCT: Actual 450 ICTRP: 450 DRKS: NA,448,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1093/eurheartj/ehy220,NA,2013-01-03,NA,2013-01-31,2018-11-30,Interventional,A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions,A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions,Completed,N/A,450,Actual,Euro CTO Club,Quality of Life Seattle Angina Questionnaire (SAQ);Major cardiovascular events,Safety and efficacy endpoints;Procedural complications;Protocol adherence;Per protocol analysis,2011-005905-64,A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions,A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions,,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,N/A,2013-01-01,2013-01-20,450,Completed,Euro CTO Club,"NHS Research and Development;Biosensors International;Asahi Intecc Co., Ltd.",france;germany;italy;latvia;spain;united kingdom;france;germany;italy;latvia;spain;united kingdom,Device: Biolimus-eluting stent implantation,"
Inclusion Criteria:
- = 18 years of age with written informed consent
- CTO in native coronary artery
- a) Stable angina, or b) myocardial ischaemia in a territory supplied by CTO, and c)
viability in akinetic myocardium (<50% transmural late enhancement on MRI or normal
resting perfusion scan)
- CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)
- target artery =2.5mm
Exclusion Criteria:
- AMI or NSTE-ACS within 1 month
- Significant untreated coronary stenosis in a territory other than CTO
- Patients with MVD and significant non-CTO stenoses where it is deemed unsafe to treat
the non-CTO lesion first (e.g. Significant proximal LAD lesion with chronically
occluded RCA)
- Patient unsuitable for 12 month dual anti-platelet therapy
- Any exclusion criteria for PCI or DES
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year
following index procedure
",NULL,Quality of Life Seattle Angina Questionnaire (SAQ);Major cardiovascular events,Safety and efficacy endpoints;Procedural complications;Protocol adherence;Per protocol analysis,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-01-31,2013-01-01,2013-01-01,450,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,2019-06-29,TRUE,FALSE,FALSE
7910,NCT01875120,NA,NCT01875120,NCT: 2013-06-07 ICTRP: 2013-06-07 DRKS: NA,1,1,NA,1,1,NA,NA,NA,NA,NA,3,1,"no AM, no measure",NA,NA,NA,NCT: Actual 160 ICTRP: 160 DRKS: NA,135,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1097/eja.0000000000000979,NA,2013-06-11,NA,2012-10-31,2013-10-31,Observational,Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV,Prospective Observational Study to Evaluate Somatic Symptom Load and Anxiety Sensitivity as Risk Factors for Postoperative Nausea and Vomiting (PONV),Completed,NA,160,Actual,Johannes Gutenberg University Mainz,Occurrence of postoperative nausea and vomiting (PONV).,,837.327.12 (8428-F),Study to Evaluate Anxiety Sensitivity and Somatic Symptoms as Risk Factors for PONV,Prospective Observational Study to Evaluate Somatic Symptom Load and Anxiety Sensitivity as Risk Factors for Postoperative Nausea and Vomiting (PONV),NULL,NULL,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2013-06-07,2012-10-20,160,Completed,Johannes Gutenberg University Mainz,NULL,germany,NULL,
Inclusion Criteria:
- female patients 18-75 years
- non-smokers
- must be able to give written informed consent
- planned surgical intervention requiring hospitalisation
- not included in another clinical trial
Exclusion Criteria:
- emergency intervention
- total intravenous anesthesia (TIVA) with propofol
- disability to give written informed consent
- physical or psychic disorders requiring permanent psycho-social care
- no German language skills
,NULL,Occurrence of postoperative nausea and vomiting (PONV).,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-10-31,2013-06-07,2013-06-07,160,Observational,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2012,2013-11-08,TRUE,FALSE,FALSE
8134,NCT01832740,NA,NCT01832740,NCT: 2013-03-08 ICTRP: 2013-03-08 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",3,NA,"no AM, no metric",NCT: Anticipated 22 ICTRP: 22 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2013-04-16,NA,2013-01-31,2015-01-31,Interventional,"Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Younger, Healthy Subjects","Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Younger, Healthy Subjects",Completed,N/A,22,Anticipated,"Charite University, Berlin, Germany","Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS",1. Amount of Slow wave Sleep;2. sleep spindels;3. EEG-correlates;4. further memory systems,Nighttime sleep-tSOS-Young,"Effects of Brain Stimulation During Nocturnal Sleep on Memory Consolidation in Younger, Healthy Subjects","Impact of Transcranial Slow Oscillating Stimulation on Memory Consolidation During Nocturnal Slow Wave Sleep in Younger, Healthy Subjects",,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment",N/A,2013-03-08,2013-01-20,22,Completed,"Charite University, Berlin, Germany",NULL,germany,Device: brain stimulation;Device: SHAM,"
Inclusion Criteria:
- healthy Subjects
- unobtrusive, neuropsychological screening
- age: 18-35 years
- right handed
Exclusion Criteria:
- untreated severe internal or psychiatric diseases
- epilepsy
- other severe neurological diseases eg., previous major stroke, brain tumour
- contraindications to MRI
",NULL,"Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS",1. Amount of Slow wave Sleep;2. sleep spindels;3. EEG-correlates;4. further memory systems,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-01-31,2013-03-08,2013-03-08,22,Interventional,TRUE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2013,2016-03-15,TRUE,FALSE,FALSE
17907,NCT00191516,NA,NCT00191516,NCT: 2005-09-12 ICTRP: 2005-09-12 DRKS: NA,1,1,NA,1,0,NA,"In register children 6-12, in article 6-17y",2,1,"info from description; target dose correct, but could be adjusted within a range according to article",4,1,no AM,4,0,no AM; PAERS not reported,NCT: NA 257 ICTRP: 257 DRKS: NA,213,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1007/s12402-010-0022-2,NA,2005-09-19,NA,2004-10-31,2006-02-28,Interventional,An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder,"An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany",Completed,Phase 3,257,NA,Eli Lilly and Company,"Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24",Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.;O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment,B4Z-SB-LYDD;9496,An Open-Label Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder,"An Open-Label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children With Attention-Deficit/Hyperactivity Disorder in Germany",,,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 3,2005-09-12,2004-10-20,257,Completed,Eli Lilly and Company,NULL,germany,Drug: Atomoxetine,
Inclusion Criteria:
- Male or female outpatients who are at least 6 years of age and who will not have
reached their 12th birthday
- Diagnosis of ADHD
- Normal intelligence
Exclusion Criteria:
- Weigh less than 20 kg or more than 60 kg at study entry
- Other relevant psychiatric diagnoses
- Are at serious suicidal risk as determined by the investigator
- Have a history of severe allergies
- Alcohol or drug abuse within the past 3 months
,NULL,"Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24",Pediatric Adverse Events Rating Scale (PAERS) during 8 and 24 weeks of treatment.;O'Brien Sleep Questionnaire during 8 and 24 weeks of treatment,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-10-31,2005-09-12,2005-09-12,257,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2004,2007-01-24,TRUE,FALSE,FALSE
11984,NCT01182428,NA,NCT01182428,NCT: 2010-07-13 ICTRP: 2010-07-13 DRKS: NA,1,1,NA,2,0,"NA; Typo? Target lesion <28mm in article, but >28mm in register",NA,1,1,NA,5,1,NA,5,1,NA,NCT: Actual 455 ICTRP: 455 DRKS: NA,455,1,1,1,0,"NA; single-blind (participant) in register, some personnel blinded in article and no info on blinding of participants",Single (Participant),None,worse,1,NA,ganzer Artikel,https://doi.org/10.1371/journal.pone.0182632,NA,2010-08-16,NA,2008-09-30,2011-07-31,Interventional,XIENCE V: SPIRIT WOMEN Sub-study,A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions,Completed,Phase 4,455,Actual,Abbott Medical Devices,"Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;In-stent Late Loss (LL) (Main Secondary Endpoint)","Aneurysm;Adjudicated Revascularization (TLR/TVR/All Revascularizations);Clinical Device Success;Clinical Procedure Success;Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable, Possible);Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).;Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.;Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.;Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;In-segment Late Loss (LL);In-stent Angiographic Binary Restenosis Rates;In-segment Angiographic Binary Restenosis Rates;In-stent Percent Diameter Stenosis;In-segment Percent Diameter Stenosis;Adjudicated Revascularization (TLR/TVR/All Revascularizations);Adjudicated Revascularization (TLR/TVR/All Revascularizations);Thrombus;Persisting Dissection",07-377 sub-study,XIENCE V: SPIRIT WOMEN Sub-study,A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions,;;;;;;;,;;;;;;;,Interventional,,Phase 4,2010-07-13,2008-09-20,455,Completed,Abbott Vascular,NULL,argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland;argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland;argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland;argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland;argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland;argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland;argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland;argentina;austria;belgium;brazil;denmark;france;germany;hungary;italy;latvia;netherlands;norway;poland;spain;switzerland,Device: XIENCE V®/ XIENCE PRIME™;Device: CYPHER SELECT;Device: XIENCE V®/ XIENCE PRIME™;Device: CYPHER SELECT;Device: XIENCE V®/ XIENCE PRIME™;Device: CYPHER SELECT;Device: XIENCE V®/ XIENCE PRIME™;Device: CYPHER SELECT,"
General Inclusion Criteria:
- Patient must be female.
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment
alternatives and she or her legally authorized representative provides written
informed consent prior to any study related procedure, as approved by the appropriate
Medical Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,
silent ischemia, positive functional study or a reversible change in the
electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patients of childbearing potential must have had a negative pregnancy test within 7
days before treatment, and must not be nursing at the time of treatment.
Angiographic Inclusion Criteria:
- Patients' artery morphology and disease is suitable to be optimally treated with a
maximum of 4 planned study stents.
- Target lesions must be de novo lesions (no prior stent implant, no prior
brachytherapy).
- Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.
The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
- Target lesion greater than or equal to 28 mm in length by visual estimate.
General Exclusion Criteria:
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known
history of substance abuse (alcohol, cocaine, heroin etc.) that may cause
non-compliance with the clinical investigation plan, confound the data interpretation
or is associated with a limited life expectancy (i.e., less than one year).
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or
bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,
tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
adequately pre-medicated.
- Participation in another device or drug study or has completed the follow-up phase of
another study within the last 30 days.
- Patient who is judged to have a lesion that prevents complete inflation of an
angioplasty balloon.
- Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug
Eluting Stent (DES) within the target vessel(s)
;
General Inclusion Criteria:
- Patient must be female.
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment
alternatives and she or her legally authorized representative provides written
informed consent prior to any study related procedure, as approved by the appropriate
Medical Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,
silent ischemia, positive functional study or a reversible change in the
electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patients of childbearing potential must have had a negative pregnancy test within 7
days before treatment, and must not be nursing at the time of treatment.
Angiographic Inclusion Criteria:
- Patients' artery morphology and disease is suitable to be optimally treated with a
maximum of 4 planned study stents.
- Target lesions must be de novo lesions (no prior stent implant, no prior
brachytherapy).
- Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.
The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
- Target lesion greater than or equal to 28 mm in length by visual estimate.
General Exclusion Criteria:
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known
history of substance abuse (alcohol, cocaine, heroin etc.) that may cause
non-compliance with the clinical investigation plan, confound the data interpretation
or is associated with a limited life expectancy (i.e., less than one year).
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or
bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,
tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
adequately pre-medicated.
- Participation in another device or drug study or has completed the follow-up phase of
another study within the last 30 days.
- Patient who is judged to have a lesion that prevents complete inflation of an
angioplasty balloon.
- Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug
Eluting Stent (DES) within the target vessel(s)
;
General Inclusion Criteria:
- Patient must be female.
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment
alternatives and she or her legally authorized representative provides written
informed consent prior to any study related procedure, as approved by the appropriate
Medical Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,
silent ischemia, positive functional study or a reversible change in the
electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patients of childbearing potential must have had a negative pregnancy test within 7
days before treatment, and must not be nursing at the time of treatment.
Angiographic Inclusion Criteria:
- Patients' artery morphology and disease is suitable to be optimally treated with a
maximum of 4 planned study stents.
- Target lesions must be de novo lesions (no prior stent implant, no prior
brachytherapy).
- Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.
The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
- Target lesion greater than or equal to 28 mm in length by visual estimate.
General Exclusion Criteria:
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known
history of substance abuse (alcohol, cocaine, heroin etc.) that may cause
non-compliance with the clinical investigation plan, confound the data interpretation
or is associated with a limited life expectancy (i.e., less than one year).
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or
bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,
tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
adequately pre-medicated.
- Participation in another device or drug study or has completed the follow-up phase of
another study within the last 30 days.
- Patient who is judged to have a lesion that prevents complete inflation of an
angioplasty balloon.
- Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug
Eluting Stent (DES) within the target vessel(s)
;
General Inclusion Criteria:
- Patient must be female.
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment
alternatives and she or her legally authorized representative provides written
informed consent prior to any study related procedure, as approved by the appropriate
Medical Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina,
silent ischemia, positive functional study or a reversible change in the
electrocardiogram (ECG) consistent with ischemia).
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG)
surgery.
- Patient must agree to undergo all protocol-required follow-up examinations.
- Patients of childbearing potential must have had a negative pregnancy test within 7
days before treatment, and must not be nursing at the time of treatment.
Angiographic Inclusion Criteria:
- Patients' artery morphology and disease is suitable to be optimally treated with a
maximum of 4 planned study stents.
- Target lesions must be de novo lesions (no prior stent implant, no prior
brachytherapy).
- Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate.
The diameter range will be expanded to 2.25 mm when the 2.25 mm stent is available.
- Target lesion greater than or equal to 28 mm in length by visual estimate.
General Exclusion Criteria:
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known
history of substance abuse (alcohol, cocaine, heroin etc.) that may cause
non-compliance with the clinical investigation plan, confound the data interpretation
or is associated with a limited life expectancy (i.e., less than one year).
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or
bivalirudin, both clopidogrel and ticlopidine, everolimus, cobalt, chromium, nickel,
tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be
adequately pre-medicated.
- Participation in another device or drug study or has completed the follow-up phase of
another study within the last 30 days.
- Patient who is judged to have a lesion that prevents complete inflation of an
angioplasty balloon.
- Patient has had a previous stent implant, either Bare Metal Stent (BMS) or Drug
Eluting Stent (DES) within the target vessel(s)
",NULL,"Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;In-stent Late Loss (LL) (Main Secondary Endpoint);Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;In-stent Late Loss (LL) (Main Secondary Endpoint)","Clinical Device Success;Clinical Procedure Success;Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable);Adjudicated Stent Thrombosis (Definite, Probable, Possible);Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and Clinically Indicated Target Lesion Revascularization (CI-TLR).;Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.;Adjudicated Composite Rate of Cardiac Death, MI Attributed to the Target Vessel and CI-TLR.;Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;Adjudicated Composite Rate of All Death, All MI and Target Vessel Revascularization (TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Composite Rate of All Death, All MI and All Revascularization (TLR/TVR/Non TVR).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;Adjudicated Cardiac Death, Non-Cardiovascular Death, Vascular Death, Q-wave MI and Non Q-wave MI (Peri-Procedural, Unrelated to PCI).;In-segment Late Loss (LL);In-stent Angiographic Binary Restenosis Rates;In-segment Angiographic Binary Restenosis Rates;In-stent Percent Diameter Stenosis;In-segment Percent Diameter Stenosis;Adjudicated Revascularization (TLR/TVR/All Revascularizations);Adjudicated Revascularization (TLR/TVR/All Revascularizations);Adjudicated Revascularization (TLR/TVR/All Revascularizations);Aneurysm;Thrombus;Persisting Dissection",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-09-30,2010-07-13,2010-07-13,455,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2008,2012-07-23,TRUE,FALSE,FALSE
14566,NCT00740896,NA,NCT00740896,NCT: 2008-08-22 ICTRP: 2008-08-22 DRKS: NA,1,1,NA,2,0,NA,age range 20-50 in article instead of >18,2,1,NA,3,0,"no AM, time frame seems incorrect",4,0,time frame seems incorrect,NCT: Actual 16 ICTRP: 16 DRKS: NA,16,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,10.1183/09031936.00090109,NA,2008-08-25,NA,2008-06-30,2008-12-31,Interventional,Acute Effects of Smoking on Airway Dendritic Cells,Acute Effects of Smoking on Airway Dendritic Cells,Completed,N/A,16,Actual,University of Rostock,Total number of dendritic cells in bronchoalveolar lavage fluid,Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid,LO-2222,Acute Effects of Smoking on Airway Dendritic Cells,Acute Effects of Smoking on Airway Dendritic Cells,,,Interventional,"Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science",N/A,2008-08-22,2008-06-20,16,Completed,University of Rostock,German Research Foundation,germany,Behavioral: Smoking;Behavioral: Smoking,
Inclusion Criteria:
- Active smoking (at least 10 cigarettes per day)
- Age > 18 years
Exclusion Criteria:
- Any chronic diseases
- Any regular medication
- Any signs or symptoms of an acute infection
,NULL,Total number of dendritic cells in bronchoalveolar lavage fluid,Surface molecule expression on dendritic cells in bronchoalveolar lavage fluid,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-06-30,2008-08-22,2008-08-22,16,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2008,2009-04-07,TRUE,FALSE,FALSE
16171,NCT00464321,NA,NCT00464321,NCT: 2007-04-20 ICTRP: 2007-04-20 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",2,NA,"no AM, no metric, no measure",NCT: Actual 16 ICTRP: 16 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-04-23,NA,2007-05-31,2010-02-28,Interventional,Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS,"A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)",Completed,Phase 1,16,Actual,Sanofi,To determine Safety and tolerability of single dose infusions of GC1008 in patients with treatment resistant idiopathic FSGS and nephrotic range proteinuria;Pharmacokinetics of GC1008 following a single dose infusion,To investigate Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy.,GC1008FSGS00505,Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS,"A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)",,,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 1,2007-04-20,2007-05-20,16,Completed,"Genzyme, a Sanofi Company",NULL,united states;germany;italy;united kingdom;united states;germany;italy;united kingdom,Biological: GC1008;Biological: GC1008;Biological: GC1008;Biological: GC1008,"
Inclusion Criteria:
- GFR=25ml/min/1.73m2 calculated by the MDRD equation
- Urinary total protein: creatinine ratios >200mg/mmol derived from the average of 2
first morning voids taken during screening period
- Biopsy confirmed as idiopathic FSGS by a central reviewer
- Treatment resistance. NOTE:Patients to have received minimum 6 week course of
steroids or immunosuppressant
- If receiving treatment with an ACEi and/or ARB dose to be stable for a minimum of 4
weeks prior to randomization
- Influenza vaccine (according to season)
- Negative screening per American Cancer Society (ACS) 2003 guidelines, as
appropriate to patient demographics and clinical status
Exclusion Criteria:
- Secondary FSGS
- steroid resistant patients who are unable to reduce their steroid dose to <10mg/day
of prednisolone or equivalent 4 weeks prior to study dosing day
- Positive serology for serious infections (including but not limited to infection with
Hep B or C, HIV)
- Concomitant illnesses:Diabetes Type I; Cardiac or Hepatic disease, HIV; Cancer,
precancerous state (eg familial adenomatous polyposis; Any condition requiring
treatment with other immunosuppressant drugs within 4 weeks prior to dosing day or
during the course of the study
- Pre-existing oral-pharyngeal disease (dental carries and other minor dental disease
are acceptable)
- Haemoglobin level of <9.0g/dL prior to dosing
- Treatment with coumadin, anti-vitamin K analogues or low molecular weight heparins.
Patients must have stopped treatment a minimum of four weeks prior to receiving study
medication.
- Patients requiring ongoing treatment with non-steroidal anti-inflammatory drugs
(NSAIDs). Patients must have stopped treatment a minimum of four weeks prior to
receiving study medication.
- Patients who have had surgery/fracture within 3 months prior to dosing day
- History of cancer unresolved within 5 years prior to screening or a known
precancerous state; or any form of skin cancer either current or past history
- Women who are pregnant, lactating or who plan to become pregnant within 4 months of
infusion
- Women of childbearing potential unless taking medically acceptable contraceptive
- Men with female partners of childbearing potential unless they are taking medically
acceptable contraceptive precautions
- Use of any investigation drug administered as part of a clinical trial within 4 weeks
prior to commencing screening
- Other clinically significant, uncontrolled medical condition that in the
investigator's opinion may interfere with the assessment or follow-up
- Active ethanol or drug abuse, excluding tobacco use
- Electrocardiogram (ECG) abnormalities considered to be clinically significant at
screening
- Unable to comply with the requirements of the study
- Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or use
of anticoagulation therapy (including anti-platelet agents). Patients with a history
of deep venous thrombosis may participate if successfully treated, completely
resolved, and no treatment has been given for >4 months.
",NULL,To determine Safety and tolerability of single dose infusions of GC1008 in patients with treatment resistant idiopathic FSGS and nephrotic range proteinuria;Pharmacokinetics of GC1008 following a single dose infusion,To investigate Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy.,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-05-31,2007-04-20,2007-04-20,16,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,2014-03-17,TRUE,FALSE,FALSE
5122,NCT02477111,NA,NCT02477111,NCT: 2015-05-30 ICTRP: 2015-05-30 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,4,NA,no AM,4,NA,no AM,NCT: Anticipated 150 ICTRP: 150 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2015-06-22,NA,2015-03-31,2020-04-30,Observational,European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms,"A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms",Unknown status,NA,150,Anticipated,Cordis Corporation,Absence of major adverse events,Occurence of major adverse events;Technical success defined as successful insertion and deployment of the device in the intended location .;Successful aneurysm repair defined as absence of Type I or III endoleak and absence of aneurysm enlargement confirmed on imaging.;Absence of stent graft migration (> 10 mm);Absence of stent graft fracture;Absence of aneurysm sac rupture;Amount of time it takes to complete the procedure;Amount of time fluoroscopy is used during the procedure;Amount of contrast volume used during the procedure,P13-4601,European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms,"A Multicenter, Open Label, Prospective, Post Approval Study of the INCRAFT® Abdominal Aortic Aneurysm (AAA) Stent Graft System in Subjects With Abdominal Aortic Aneurysms",;,;,Observational,,,2015-05-30,2015-03-20,150,Unknown status,Cordis Corporation,NULL,germany,Device: Endovascular abdominal aortic aneurysm repair,"
Inclusion Criteria:
1. Male or Female age 18 years or older
2. Femoral access vessels should be adequate to fit the selected delivery system
3. Proximal neck length = 10mm
4. Aortic neck diameters = 17mm and = 31mm
5. Aortic neck suitable for suprarenal fixation
6. Infrarenal and suprarenal neck angulation = 60°
7. Iliac fixation length = 15mm
8. Iliac diameters = 7mm and = 22mm
9. Minimum overall AAA treatment length (proximal landing location to distal landing
location) = 128mm
10. Morphology suitable for aneurysm repair
11. Provide written informed consent and as applicable written confidentiality
authorization prior to initiation of study procedures
12. Subject is willing to comply with the specified follow-up evaluation schedule
Exclusion Criteria:
1. Subject has one of the following:
1. Aneurysm sac rupture or leaking abdominal aortic aneurysm
2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm
2. Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate
(PET), or polytetrafluoroethylene (PTFE)
3. Known contraindication to undergoing angiography or anticoagulation
4. Existing AAA surgical graft and/or a AAA stent-graft system
5. Women of child bearing potential whom are pregnant, lactating, or planning to become
pregnant during the course of the trial
",NULL,Absence of major adverse events,Occurence of major adverse events;Technical success defined as successful insertion and deployment of the device in the intended location .;Successful aneurysm repair defined as absence of Type I or III endoleak and absence of aneurysm enlargement confirmed on imaging.;Absence of stent graft migration (> 10 mm);Absence of stent graft fracture;Absence of aneurysm sac rupture;Amount of time it takes to complete the procedure;Amount of time fluoroscopy is used during the procedure;Amount of contrast volume used during the procedure,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-03-31,2015-05-30,2015-05-30,150,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2015,2018-01-25,TRUE,FALSE,FALSE
25073,NCT02110459,DRKS00006452,DRKS00006452,NCT: NA ICTRP: 2015-02-17 DRKS: 2015-02-17,1,NA,NA,2,NA,NA,NA,1,NA,no dosage,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 40 DRKS: [---]* 40,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2014-04-10,NA,2013-04-30,2015-07-31,Interventional,Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment,"An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of POL7080 Administered as Single Intravenous Infusion to Subjects With Renal Impairment",Completed,Phase 1,48,Actual,Polyphor Ltd.,To measure the plasma concentrations of POL7080,Adverse events;Laboratory abnormalities,POL7080-005,Pharmacokinetics and Safety of POL7080 in Patients With Renal Impairment,"An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of POL7080 Administered as Single Intravenous Infusion to Subjects With Renal Impairment",,,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science",Phase 1,2014-04-08,2013-04-20,48,Completed,Polyphor Ltd.,NULL,germany,Drug: POL7080,"
Inclusion Criteria:
1. Subjects who signed informed consent.
2. Male subjects =18 and =79 years of age; female subjects =18 and =79 years of age of
non-childbearing potential
3. Weight within a BMI range of 19.0-35.0 kg/m2.
4. CLCr according to Cockcroft Gault equation of:
- 50-80 mL/min (mild renal impairment)
- 30- <50 mL/min (moderate renal impairment)
- <30 mL/min (severe renal impairment)
- subjects receiving dialysis for =3 months before dosing (ESRD)
- >80 mL/min (normal renal function)
Exclusion Criteria:
1. Unwilling or unable to give informed consent.
2. As a result of the medical screening process, the study physician considers the
subject unfit for the study.
3. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or
equivalent per day).
4. Subjects who smoke more than 10 cigarettes a day.
5. Subjects who consume more than 28 units (males) or more than 21 units (females) of
alcohol per week.
6. Any history of hypersensitivity to the IMP.
7. For subjects with renal impairment: No clinically significant change in disease
status within at least 1 month prior to study entry, as determined by the
investigator.
8. The subject had donated a unit of blood (450 mL) within the 3 months before dosing,
or intends to donate in the month after the last scheduled visit.
9. Participation in another clinical study with an investigational drug or device within
the last month.
10. Subjects with clinically significant telemetric ECG abnormalities on Day -1
11. Significant allergies requiring intranasal or systemic corticosteroids during any
time of the year or history of any anaphylactic reaction.
12. Positive test for human immunodeficiency virus (HIV) antibodies.
13. Acute Hepatitis B or C infection.
14. The subject has tested positive for drugs of abuse at screening.
15. Subjects who have received any prescribed systemic or topical medication within 4
weeks prior to dosing (excluded are those drugs the renally impaired subject is
currently taking for treatment of the renal or concomitant disease).
16. Immunocompromised patients (patients after solid organ or bone marrow transplant;
patients receiving immunosuppressive treatment).
17. Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients
with cystic fibrosis).
18. Subjects with significant liver function abnormalities
19. Subjects with acute myocardial infection or unstable angina pectoris
",NULL,To measure the plasma concentrations of POL7080,Adverse events;Laboratory abnormalities,NCT02110459; POL7080-005,2015-02-17,no,Renal Impairment; Chronic kidney disease,Arm 1 Drug: POL7080,Interventional,Non-randomized controlled trial,Open (masking not used),NA,Parallel,I,"- To measure the plasma concentrations of POL7080; time frame: at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion
","- Adverse events; time frame: Daily assessment up to 7 days from informed consent; Number of adverse events reported by the patients or observed by the investigator will be recorded. Onset, end date, severity, causal relationship, outcome and measures taken will be summarized. Discontinuations and serious adverse events will be listed and narrative summaries will be provided.
- Laboratory abnormalities; time frame: Screening, Day -1, Day 2, Day 3, and Day 7; The number and severity of blood chemistry and hematology findings will be summarized descriptively and compared to baseline.
",Germany,[---]* Kiel,2013-02-27,NA,40,NA,- 1. Subjects who signed informed consent.
- 2. Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of
age of non-childbearing potential
- 3. Weight within a BMI range of 19.0-35.0 kg/m2.
- 4. CLCr according to Cockcroft Gault equation of:
- 50-80 mL/min (mild renal impairment)
- 30- <50 mL/min (moderate renal impairment)
- <30 mL/min (severe renal impairment)
- subjects receiving dialysis for ≥3 months before dosing (ESRD)
,"- 1. Unwilling or unable to give informed consent.
- 2. As a result of the medical screening process, the study physician considers the
subject unfit for the study.
- 3. Demonstrating excess in xanthine consumption (more than 5 cups of coffee or
equivalent per day).
- 4. Subjects who smoke more than 10 cigarettes a day.
- 5. Subjects who consume more than 28 units (males) or more than 21 units (females) of
alcohol per week.
- 6. Any history of hypersensitivity to the IMP.
- 7. For subjects with renal impairment: No clinically significant change in disease
status within at least 1 month prior to study entry, as determined by the
investigator.
- 8. The subject had donated a unit of blood (450 mL) within the 3 months before
dosing, or intends to donate in the month after the last scheduled visit.
- 9. Participation in another clinical study with an investigational drug or device
within the last month.
- 10. Subjects with clinically significant telemetric ECG abnormalities on Day -1
- 11. Significant allergies requiring intranasal or systemic corticosteroids during any
time of the year or history of any anaphylactic reaction.
- 12. Positive test for human immunodeficiency virus (HIV) antibodies.
- 13. Acute Hepatitis B or C infection.
- 14. The subject has tested positive for drugs of abuse at screening.
- 15. Subjects who have received any prescribed systemic or topical medication within 4
weeks prior to dosing (excluded are those drugs the renally impaired subject is
currently taking for treatment of the renal or concomitant disease).
- 16. Immunocompromised patients (patients after solid organ or bone marrow transplant;
patients receiving immunosuppressive treatment).
- 17. Subjects with known or suspected Pseudomonas infection or colonization (e.g.
patients with cystic fibrosis).
","An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of POL7080 Administered as Single Intravenous Infusion to Subjects With Renal Impairment",Recruiting ongoing,Polyphor Ltd.; CRS Clinical Research Services Kiel GmbH; [---]*,[---]*; [---]*; Klaus.Dembowsky@polyphor.com,Arm 1 Drug: POL7080,2013-04-30,2014-04-08,2014-04-08,48,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2013,2016-06-16,TRUE,TRUE,FALSE
8397,NCT01777958,NA,NCT01777958,NCT: 2013-01-25 ICTRP: 2013-01-25 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,5,NA,NA,3,NA,"no AM, no metric",NCT: Actual 135 ICTRP: 135 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2013-01-29,NA,2013-06-14,2020-11-25,Observational,HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy,"Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)",Completed,NA,135,Actual,Hoffmann-La Roche,Median progression-free survival in routine clinical practice,Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration;Clinical/demographic patients characteristics at initiation of treatment;Safety: Incidence of adverse events;Patient reported outcome: Quality of life (FACT B questionnaire),ML28750,HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy,"Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)",,,Observational,,,2013-01-25,2013-06-14,135,Completed,Hoffmann-La Roche,NULL,germany,NULL,"
Inclusion Criteria:
- Female adult patients, >/= 18 years of age
- HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)
relapsing after completed adjuvant Herceptin therapy
- Indication for first-line treatment with Perjeta in combination with Herceptin and
chemotherapy according to the Summary of Product Characteristics
- Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a
potentially curable setting); additional upfront neoadjuvant Herceptin therapy is
allowed
- No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally
recurrent, inoperable) HER2-positive breast cancer
Exclusion Criteria:
- Pregnant or breastfeeding women
- Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the
Summary of Product Characteristics
- No Herceptin treatment for early breast cancer in the adjuvant setting
",NULL,Median progression-free survival in routine clinical practice,Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration;Clinical/demographic patients characteristics at initiation of treatment;Safety: Incidence of adverse events;Patient reported outcome: Quality of life (FACT B questionnaire),NCT01777958; ML28750,2014-04-25,no,Breast Cancer; Malignant neoplasm of breast,,Non-interventional,NA,NA,NA,NA,N/A,- Median progression-free survival in routine clinical practice; time frame: approximately 7.5 years
,- Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration; time frame: approximately 7.5 years
- Clinical/demographic patients characteristics at initiation of treatment; time frame: approximately 7.5 years
- Safety: Incidence of adverse events; time frame: approximately 7.5 years
- Patient reported outcome: Quality of life (FACT B questionnaire); time frame: approximately 7.5 years
,Germany,[---]* Frankfurt,2013-06-30,NA,478,NA,"- Female adult patients, >/= 18 years of age
- HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)
relapsing after completed adjuvant Herceptin therapy
- Indication for first-line treatment with Perjeta in combination with Herceptin and
chemotherapy according to the Summary of Product Characteristics
- Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a
potentially curable setting); additional upfront neoadjuvant Herceptin therapy is
allowed
- No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally
recurrent, inoperable) HER2-positive breast cancer
","- Pregnant or breastfeeding women
- Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the
Summary of Product Characteristics
- No Herceptin treatment for early breast cancer in the adjuvant setting
","Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)",Recruiting ongoing,Hoffmann-La Roche; Hoffmann-La Roche; [---]*,[---]*; [---]*; global.rochegenentechtrials@roche.com,,2013-06-14,2013-01-25,2013-01-25,135,Observational,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2013,2020-12-10,TRUE,TRUE,FALSE
10053,NCT01480323,NA,NCT01480323,NCT: 2011-11-23 ICTRP: 2011-11-23 DRKS: NA,1,1,NA,2,1,NA,NA,2,NA,"NA; some differences in injection days, each difference = 1 day",5,1,NA,5,1,NA,NCT: Actual 15 ICTRP: 15 DRKS: NA,15,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,10.1007/s00262-016-1944-0,NA,2011-11-28,NA,2012-02-29,2015-06-30,Interventional,A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2,A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2 in Pretreated Patients With Stage IV Melanoma,Completed,Phase 2,15,Actual,University Hospital Tuebingen,Control rate,Tolerability;Overall survival;Best Overall Response Rate;Overall response rate;Overall Response Rate;Best Overall Response Rate;Response rate of injected metastases only;Rate of patients with substantial increase of anti-melanoma T-cells in peripheral blood during treatment;Changes in T-cell subsets during treatment;Changes in subsets of tumor-infiltrating lymphocytes during treatment,5027000,A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2,A Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Intratumoral Interleukin-2 in Pretreated Patients With Stage IV Melanoma,,,Interventional,"Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 2,2011-11-23,2012-02-20,15,Completed,University Hospital Tuebingen,NULL,germany,Drug: Interleukin-2;Drug: Ipilimumab,"
Inclusion Criteria:
- Willing and able to give written informed consent;
- Histological diagnosis of malignant melanoma;
- Stage IV melanoma;
- At least one injectable lesions > 5 mm (longest diameter) or at least 5 injectable
lesions < 5 mm.
- Measurable disease. Note: lesions, which are designated for direct IL -2 injections,
must not be considered in the evaluation of measurability;
- Men and women, at least 18 years of age;
- Patient must have demonstrated 1 of the following in response to at least 1 cycle of
1 or more systemic regimens:
1. relapse following an objective response (PR/CR);
2. failed to demonstrate an objective response (PR/CR); or
3. inability to tolerate treatment due to unacceptable toxicity
- At least 4 weeks since treatment (chemotherapy, biochemotherapy, surgery, radiation,
immunotherapy, etc.) for melanoma and recovered from any clinically significant
toxicity experienced during treatment;
- Life expectancy =3 months;
- ECOG performance status of 0 or 1;
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before
the start of ipilimumab;
- No known active or chronic infection with HIV, Hepatitis B, or Hepatitis C
- Required values for initial laboratory tests:
- Men of fathering potential must be using an adequate method of contraception to avoid
conception throughout the study and for up to 26 weeks after the last dose of
investigational product in such a manner that the risk of pregnancy is minimized
Exclusion Criteria:
- Any other prior malignancy from which the patient has been disease-free for less than
5 years, with the exception of adequately treated and cured basal or squamous cell
skin cancer, superficial bladder cancer or carcinoma in situ of the cervix;
- Ocular melanoma; mucosal melanoma
- Either untreated or symptomatic central nervous system (CNS) metastases (patients
with brain metastases who are identified at screening may be rescreened after the
lesion(s) have been appropriately treated);
- Autoimmune disease: Patients with a history of inflammatory bowel disease are
excluded from this study, as are patients with a history of symptomatic autoimmune
disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma],
systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's
Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g.,
Guillain-Barre Syndrome). Patients with vitiligo may be included.
- Any underlying medical or psychiatric condition, which in the opinion of the
investigator will make the administration of ipilimumab hazardous or obscure the
interpretation of AEs, such as a condition associated with frequent diarrhea.
- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up
to 1 month before or after any dose of ipilimumab).
- A history of prior systemic treatment with ipilimumab, CD137 agonist, CTLA 4
inhibitor, CTLA-4 agonist or IL-2 in stage IV melanoma.
- Concomitant or less than 4 weeks off therapy with any of the following: interferon;
other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive
agents; other investigation therapies; chronic use of systemic corticosteroids.
- Women of childbearing potential (WOCBP), defined in Section 5.3, who:
1. are unwilling or unable to use an acceptable method of contraception to avoid
pregnancy for their entire study period and for at least 26 weeks after
cessation of study drug, or
2. have a positive pregnancy test at baseline, or
3. are pregnant or breastfeeding.
- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (e.g., infectious) illness.
",NULL,Control rate,Tolerability;Overall survival;Best Overall Response Rate;Overall response rate;Overall Response Rate;Best Overall Response Rate;Response rate of injected metastases only;Rate of patients with substantial increase of anti-melanoma T-cells in peripheral blood during treatment;Changes in T-cell subsets during treatment;Changes in subsets of tumor-infiltrating lymphocytes during treatment,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-02-29,2011-11-23,2011-11-23,15,Interventional,TRUE,FALSE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2012,2015-07-17,TRUE,FALSE,FALSE
13192,NCT00982358,NA,NCT00982358,NCT: 2009-09-22 ICTRP: 2009-09-22 DRKS: NA,1,1,NA,2,1,NA,NA,1,1,no dosage,4,1,no AM,1,1,"no AM, no metric, no measure, no time frame",NCT: NA 121 ICTRP: 121 DRKS: NA,109,1,1,2,1,NA,Double,Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1016/j.diabres.2010.04.018,NA,2009-09-23,NA,2004-07-31,2007-03-31,Interventional,Anti-Inflammatory Actions of Valsartan in Patients With Type 2 Diabetes Mellitus,"A 16-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Anti-inflammatory Actions of 320 mg Diovan in Patients With Type 2 Diabetes With and Without Coronary Artery Disease",Completed,Phase 4,121,NA,"Charite University, Berlin, Germany",The primary objective of the study was to evaluate the anti-inflammatory effect of VAL by analyzing the reduction of the inflammatory markers interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα) in serum after 16 weeks of treatment.,"To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.;To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma;To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue;To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.;To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD",Ek#2140;CVAL489A2423,Anti-Inflammatory Actions of Valsartan in Patients With Type 2 Diabetes Mellitus,"A 16-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Anti-inflammatory Actions of 320 mg Diovan in Patients With Type 2 Diabetes With and Without Coronary Artery Disease",NULL,NULL,Interventional,"Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment",Phase 4,2009-09-22,2004-07-20,121,Completed,"Charite University, Berlin, Germany",University of Ulm,germany,Drug: Valsartan;Other: Placebo,"
Inclusion Criteria:
- Male or female patients between 30 and 80 years old, inclusive
- Controlled type 2 Diabetes Mellitus on stable treatment at least during the 4 weeks
prior to visit 1
- Treated or untreated stage 1 (according to JNC VII Guidelines) or grade 1 (according
to ESH/ESC 2003 Guidelines) hypertensive patients
- For one stratum: angiographically proven CAD
- Signed informed consent prior to any study procedure
Exclusion Criteria:
- Hypertension classified as stage 2 (or grade 2) or higher
- Normotensive patients, i.e. patients who do not have a history of high blood
pressure, and who are not receiving any antihypertensive medication
- Treatment with more than 2 antihypertensive medications
- Current treatment with ARBs
- Glycated hemoglobin (HbA1c) >8.5% at Visit 1
- Current treatment with glitazones
- Myocardial infarction less than 3 months prior to Visit 1
- Total cholesterol >7.8 mmol/l
- Past diagnosis of any systemic inflammatory disease
- Known or suspected contraindications, including history of allergy to angiotensin
receptor blockers
- History of hypertensive encephalopathy or cerebrovascular accident less than 1 year
prior to Visit 1
- Known Keith-Wagener grade III or IV hypertensive retinopathy
- History of heart failure
- Second or third degree heart block without a pacemaker
- Concomitant unstable angina pectoris
- Concurrent potential life threatening arrhythmia or symptomatic arrhythmia
- Clinically significant valvular heart disease
- Evidence of hepatic disease as determined by any one of the following: ALT or AST
values > 2 x ULN at Visit 1, a history hepatic encephalopathy, a history of
esophageal varices, or a history of portocaval shunt
- Evidence of renal impairment as determined by any one of the following: serum
creatinine >1.25 x ULN at visit 1, a history of dialysis, or a history of nephritic
syndrome
- Sodium value <132 mmol/L at Visit 1
- Serum potassium values <3.5 mmol/L or >5.5 mmol/L at visit 1
- Any surgical or medical condition which might alter the absorption, distribution,
metabolism, excretion of any drug
- Female patients who are not either post-menopausal for one year of surgically
sterile, and who are not using effective contraceptive methods such as barrier method
with spermicidal or an intra-uterine device. Oral contraceptive use or dermal
implants as the only means of contraception are disallowed
- Pregnant or lactating females
- Any surgical or medical condition which, at the discretion of the investigator, place
the patient at higher risk from his/her participation in the study, or are likely to
prevent the patients from complying with the requirements of the study or completing
the trial period
- History of malignancy including leukemia and lymphoma within 5 years prior to Visit 1
- History of any severe, life threatening disease within the past five years
- Any previous history of a systemic autoimmune disease
- History of drug or alcohol abuse within the last two years
- Participation in any investigational drug trial within one month prior to visit 1
",NULL,The primary objective of the study was to evaluate the anti-inflammatory effect of VAL by analyzing the reduction of the inflammatory markers interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFa) in serum after 16 weeks of treatment.,"To explore the effect of 160/320 mg valsartan on parameters of insulin sensitivity.;To explore the effect of 160/320 mg valsartan on additional inflammatory markers in plasma;To explore the effect of 160/320 mg valsartan on inflammatory gene expression from monocytes and fat tissue;To explore the effect of 160/320 mg valsartan on metabolic gene expression in fat tissue.;To explore the effect of 160/320 mg valsartan on coronary perfusion, in the group of patients with angiographically documented CAD",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-07-31,2009-09-22,2009-09-22,121,Interventional,FALSE,TRUE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2004,2009-09-22,TRUE,FALSE,FALSE
19303,NCT03465878,NA,NCT03465878,NCT: 2018-03-09 ICTRP: 2018-03-09 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,NA,3,NA,NA,NCT: Anticipated 45 ICTRP: 45 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-03-14,NA,2018-03-26,2019-11-14,Interventional,A Study of LY900014 in Participants With Type 1 Diabetes Mellitus,"A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus",Completed,Phase 1,56,Actual,Eli Lilly and Company,Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part,Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part,I8B-MC-ITSA;2017-003220-78;16695,A Study of LY900014 in Participants With Type 1 Diabetes Mellitus,"A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus",,,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator). ",Phase 1,2018-03-09,2018-03-26,56,Completed,Eli Lilly and Company,NULL,canada;germany;canada;germany,Drug: LY900014;Drug: Insulin Lispro,"
Inclusion Criteria:
- Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at
least 1 year
- Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)
Exclusion Criteria:
- Receiving any oral or injectable medication intended for the treatment of diabetes
mellitus other than insulins in the 12 months prior to screening
- More than one episode of severe hypoglycaemia in the last 6 months
- Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or
gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease,
uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
- Have obvious clinical signs or symptoms of liver disease
- Have a history of renal impairment
",NULL,Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part,Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-03-26,2018-03-09,2018-03-09,56,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,2020-06-05,TRUE,FALSE,TRUE
13349,NCT00953108,NA,NCT00953108,NCT: 2009-08-05 ICTRP: 2009-08-05 DRKS: NA,1,1,NA,2,1,r,criteria more specific in the register,2,1,NA,3,1,"No AM, no metric; (additional primary endpoint in article)",NA,NA,NA,NCT: Actual 60 ICTRP: 60 DRKS: NA,60,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.psyneuen.2013.10.008,NA,2009-08-06,NA,2009-09-30,2012-02-29,Interventional,"Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients",Impact of Quetiapine Prolong and Escitalopram on the Hypothalamic-pituitary-adrenocortical (HPA)-Axis Activity in Depressed Patients,Completed,Phase 3,60,Actual,Ludwig-Maximilians - University of Munich,serial dexamethasone/CRH tests,,QUE/09,"Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients",Impact of Quetiapine Prolong and Escitalopram on the Hypothalamic-pituitary-adrenocortical (HPA)-Axis Activity in Depressed Patients,NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 3,2009-08-05,2009-09-20,60,Completed,Ludwig-Maximilians - University of Munich,NULL,germany,Drug: quetiapine;Drug: escitalopram,"
Inclusion criteria:
For inclusion in the study patients must fulfil all of the following criteria:
1. Inpatients (the admission to hospital occurs independently from study participation)
2. Provision of written informed consent
3. A diagnosis of major depression by Diagnostic and Statistical Manual of Mental
Disorders- Fourth Edition (DSM-IV) (unipolar depression: 296.2, 296.3)
4. Female and male patients aged 18 to 65 years
5. Female patients of childbearing potential must have a negative serum human chorionic
gonadotropin (hCG) pregnancy test at enrolment and e willing to use a reliable method
of birth control (i.e. barrier method, oral contraceptive, implant, dermal
contraception, long-term injectable contraceptive, intrauterine device, or tubal
litigation) during the study.
6. Able to understand and comply with the requirements of the study as judged by the
investigator.
7. A sum score of at least 18 on the 21-item version of the Hamilton Depression Rating
Scale (21-HAMD)
Exclusion criteria:
Any of the following is regarded as a criterion for exclusion from the study:
1. Pregnancy or lactation
2. Any DSM-IV Axis I disorder not defined in the inclusion criteria
3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
a danger to self or others
4. Known intolerance or lack of response to quetiapine fumarate and/or escitalopram, as
judged by the investigator
5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding
enrolment including but not limited to: ketoconazole, itraconazole, fluconazole,
erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir,
fluvoxamine and saquinavir
6. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding
enrolment including but not limited to: phenytoin, carbamazepine, barbiturates,
rifampin, St. John's Wort, and glucocorticoids
7. Use of monoamine oxidase inhibitors (MAOIs) or other serotonergic drugs (e.g.
triptans) in the 14 days preceding enrolment
8. Use of oral anticoagulants in the 14 days preceding enrolment
9. History of bleeding disorders.
10. Use of drugs which are mainly metabolized by cytochrome P450 2D6 having a low
therapeutic index (e.g. flecainide, propafenone, metoprolol) in the 14 days preceding
enrolment
11. Administration of a depot antipsychotic injection within one dosing interval (for the
depot) before randomisation
12. Substance or alcohol dependence at enrolment (except dependence in full remission,
and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
13. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV
criteria within 4 weeks prior to enrolment
14. Medical conditions that would affect absorption, distribution, metabolism, or
excretion of study treatment
15. Unstable or inadequately treated medical illness (e.g. congestive heart failure,
angina pectoris, hypertension) as judged by the investigator
16. Involvement in the planning and conduct of the study
17. Previous enrolment or randomisation of treatment in the present study.
18. Participation in another drug trial within 4 weeks prior enrolment into this study or
longer in accordance with local requirements
19. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%.
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- Not under physician care for DM
- Physician responsible for patient's DM care has not indicated that patient's DM
is controlled.
- Physician responsible for patient's DM care has not approved patient's
participation in the study
- Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the
4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period
should not be less than 8 Weeks.
- Taking insulin whose daily dose on one occasion in the past 4 weeks has been
more than 10% above or below their mean dose in the preceding 4 weeks Note: If a
diabetic patient meets one of these criteria, the patient is to be excluded even
if the treating physician believes that the patient is stable and can
participate in the study.
20. An absolute neutrophil count (ANC) of 1.5 x 109 per liter
21. Abnormal laboratory parameters of clinical relevance before enrolment
22. Abnormal blood pressure, abnormal electrocardiogram, and/or abnormal
electroencephalogram with clinical relevance before enrolment
23. Psychotropic drugs within 3 days before and throughout the study with the exception
of zopiclon (up to 7.5 mg per day) in case of sleep difficulties and lorazepam (up to
2 mg per day) in case of inner tension and anxiety
",NULL,serial dexamethasone/CRH tests,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-09-30,2009-08-05,2009-08-05,60,Interventional,TRUE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2009,2013-02-11,TRUE,FALSE,TRUE
18812,NCT00006477,NA,NCT00006477,NCT: 2000-11-06 ICTRP: 2000-11-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,0,NA,NA,0,NA,NA,NCT: Actual 26 ICTRP: 26 DRKS: NA,NA,1,0,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2003-01-27,NA,2000-09-30,NA,Interventional,Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors,"Phase I Clinical Trial of Recombinant Viscumin (rVISCUMIN, rMISTLETOE LECTIN, rML) Administered Twice Weekly by the Subcutanous Route in Patients With Solid Tumors After Failure of Standard Therapy",Completed,Phase 1,26,Actual,European Organisation for Research and Treatment of Cancer - EORTC,NA,NA,EORTC-13001;EORTC-13001,Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors,"Phase I Clinical Trial of Recombinant Viscumin (rVISCUMIN, rMISTLETOE LECTIN, rML) Administered Twice Weekly by the Subcutanous Route in Patients With Solid Tumors After Failure of Standard Therapy",,,Interventional,Primary Purpose: Treatment,Phase 1,2000-11-06,2000-09-20,26,Completed,European Organisation for Research and Treatment of Cancer - EORTC,NULL,germany;norway;germany;norway,Dietary Supplement: mistletoe extract,"
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven progressive advanced solid tumor that is not
amenable to standard therapy (i.e., resistant to standard therapy or for which no
standard therapy exists)
- No clinically symptomatic CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT less than 2 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase less than 2 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine less than 1.4 mg/dL
Cardiovascular:
- No ECG abnormalities of clinical relevance
Other:
- No severe or unstable systemic disease or infection
- No circumstances (e.g., alcoholism or substance abuse) that would preclude study
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunostimulating substances (e.g., biologic response
modifiers or colony-stimulating factors)
- No concurrent immunostimulating substances (e.g., biologic response modifiers or
colony-stimulating factors (except in life-threatening situations))
Chemotherapy:
- At least 4 weeks since prior chemotherapy
Endocrine therapy:
- At least 4 weeks since prior systemic steroids
- At least 4 weeks since prior hormonal therapy
- No concurrent systemic steroids
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- No prior mistletoe preparations
- At least 4 weeks since prior investigational treatment
- No other concurrent anticancer agents
- No other concurrent investigational therapy
",NULL,NULL,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-09-30,2000-11-06,2000-11-06,26,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2000,2012-07-17,TRUE,FALSE,FALSE
15013,NCT00667602,NA,EUCTR2007-004754-82,NCT: 2008-04-24 ICTRP: 2007-10-12 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,0,NA,NA,NCT: Actual 662 ICTRP: 600 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2008-04-28,NA,2008-03-31,2010-10-31,Interventional,Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers,"A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers",Completed,Phase 3,662,Actual,Novartis,Percentages of Subjects With Serum Bactericidal Titer ≥ 1:8 Against N.Meningitidis Serogroup C,"Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:4 Against N.Meningitidis Serogroup C;Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, Y;Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y;Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C;Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y;Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y;Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine);Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine);Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 and Titer ≥ 1:4 Against N. Meningitidis Serogroup C;Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer ≥ 1:8 ,and Titer ≥ 1:4 Against N. Meningitidis Serogroups A, W, Y;Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C;Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y;Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C;Percentages of Subjects With Rabbit Serum Bactericidal ≥ 1:8, ≥ 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y;Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C;Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y;Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination",2007-004754-82;V59P22,Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers,"A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers",;;;,;;;,Interventional,,Phase 3,2008-04-24,2008-03-20,662,Completed,Novartis Vaccines,NULL,germany;australia;germany;australia;germany;australia;germany;australia,Biological: MenACWY-CRM197 (two doses);Biological: MenC;Biological: PCV7;Biological: DTPa-IPV-HepB-Hib;Biological: MenACWY-CRM197 (one dose);Biological: MenACWY-CRM197 (two doses);Biological: MenC;Biological: PCV7;Biological: DTPa-IPV-HepB-Hib;Biological: MenACWY-CRM197 (one dose);Biological: MenACWY-CRM197 (two doses);Biological: MenC;Biological: PCV7;Biological: DTPa-IPV-HepB-Hib;Biological: MenACWY-CRM197 (one dose);Biological: MenACWY-CRM197 (two doses);Biological: MenC;Biological: PCV7;Biological: DTPa-IPV-HepB-Hib;Biological: MenACWY-CRM197 (one dose),"
Inclusion Criteria:
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and
previously received three doses of both Prevenar and Infanrix-hexa vaccines at least
30 days before study entry
Exclusion Criteria:
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis, C.
diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- who have had household contact with and/or intimate exposure to an individual with
laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib,
C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
;
Inclusion Criteria:
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and
previously received three doses of both Prevenar and Infanrix-hexa vaccines at least
30 days before study entry
Exclusion Criteria:
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis, C.
diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- who have had household contact with and/or intimate exposure to an individual with
laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib,
C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
;
Inclusion Criteria:
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and
previously received three doses of both Prevenar and Infanrix-hexa vaccines at least
30 days before study entry
Exclusion Criteria:
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis, C.
diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- who have had household contact with and/or intimate exposure to an individual with
laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib,
C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
;
Inclusion Criteria:
- infants 6 to 8 months old inclusive, who were born after full term pregnancy and
previously received three doses of both Prevenar and Infanrix-hexa vaccines at least
30 days before study entry
Exclusion Criteria:
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis, C.
diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
- who have had household contact with and/or intimate exposure to an individual with
laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib,
C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
- Subjects with any serious, acute or chronic progressive disease
",NULL,Percentages of Subjects With Serum Bactericidal Titer = 1:8 Against N.Meningitidis Serogroup C;Percentages of Subjects With Serum Bactericidal Titer = 1:8 Against N.Meningitidis Serogroup C,"Percentages of Subjects With Human Serum Bactericidal Titer = 1:4 Against N.Meningitidis Serogroup C;Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 and Titer = 1:4 Against N. Meningitidis Serogroups A, C, W, Y;Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 and Titer = 1:4 Against N. Meningitidis Serogroups A, W, Y;Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C;Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y;Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y;Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine);Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine);Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 and Titer = 1:4 Against N. Meningitidis Serogroup C;Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 ,and Titer = 1:4 Against N. Meningitidis Serogroups A, W, Y;Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C;Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y;Percentages of Subjects With Rabbit Serum Bactericidal = 1:8, = 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C;Percentages of Subjects With Rabbit Serum Bactericidal = 1:8, = 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y;Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C;Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y;Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-03-31,2008-04-24,2008-04-24,662,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2008,2013-09-03,TRUE,FALSE,TRUE
11829,NCT01206803,NA,NCT01206803,NCT: 2010-09-21 ICTRP: 2010-09-21 DRKS: NA,1,1,NA,1,1,a,NA,NA,NA,NA,4,1,no AM,NA,NA,NA,NCT: Actual 294 ICTRP: 294 DRKS: NA,294,1,NA,NA,NA,NA,NA,NA,NA,0,no indication,ganzer Artikel,https://doi.org/10.1016/j.rbmo.2017.02.012,NA,2010-09-22,NA,2010-09-30,2014-01-31,Observational,Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients,"Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol",Completed,NA,294,Actual,University Hospital Schleswig-Holstein,number of cumulus-oocyte-complexes,,GR 3422/3-1,Ovarian Response Prediction in In Vitro Fertilization (IVF) Patients,"Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol",NULL,NULL,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2010-09-21,2010-09-20,294,Completed,University of Schleswig-Holstein,NULL,germany;norway;germany;norway;austria,Drug: Ovarian stimulation in a GnRH-antagonist protocol,"
Inclusion Criteria:
Female patients for who the treating physician decides that treatment with long acting FSH
150µg in a GnRH-antagonist protocol is indicated.
Exclusion Criteria:
Contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation,
undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) Use of hormonal
preparations within one month prior to inclusion
",NULL,number of cumulus-oocyte-complexes,NULL,NCT01206803; GR 3422/3-1,2012-11-23,yes,"Infertility, Subfertility; Female infertility",Arm 1 Drug: Ovarian stimulation in a GnRH-antagonist protocol,Non-interventional,NA,NA,NA,NA,N/A,- number of cumulus-oocyte-complexes; time frame: at the time of oocyte retrieval; the number of 'oocytes' obtained by transvaginal retrieval after ovarian stimulation
,NA,Germany; Norway,[---]* Kiel; [---]* Luebeck; [---]* Münster; [---]* Würzburg,2010-09-30,NA,240,2014-01-01,Female patients for who the treating physician decides that treatment with long acting FSH
150µg in a GnRH-antagonist protocol is indicated.
,"Contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation,
undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) Use of hormonal
preparations within one month prior to inclusion
","Polymorphisms of FSH Receptor, LH Receptor, LH and Ovarian Response to FSH in Controlled Ovarian Stimulation Using a GnRH Antagonist Protocol","Recruiting complete, follow-up complete",University of Schleswig-Holstein,NA,Arm 1 Drug: Ovarian stimulation in a GnRH-antagonist protocol,2010-09-30,2010-09-21,2010-09-21,294,Observational,FALSE,FALSE,TRUE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,TRUE,2010,2016-01-04,TRUE,TRUE,FALSE
10420,NCT01422057,NA,NCT01422057,NCT: 2011-08-09 ICTRP: 2011-08-09 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure",4,NA,no measure,NCT: Anticipated 500 ICTRP: 500 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2011-08-23,NA,2010-01-31,2016-01-31,Observational,Risk Prediction in Type II Diabetics With Ischemic Heart Disease,Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function,Unknown status,NA,500,Anticipated,Thebiosignals.com,Major cardiovascular event,Cardiovascular mortality;sudden cardiac death;Total mortality,402/2009BO2-2,Risk Prediction in Type II Diabetics With Ischemic Heart Disease,Risk Prediction in Type II Diabetics With Ischemic Heart Disease by Cardiac Autonomic Function,christine.zuern@med.uni-tuebingen.de;christine.zuern@med.uni-tuebingen.de,christine.zuern@med.uni-tuebingen.de;christine.zuern@med.uni-tuebingen.de,Observational,"Observational Model: Cohort, Time Perspective: Prospective",N/A,2011-08-09,2010-01-20,500,Recruiting,Thebiosignals.com,NULL,germany,NULL,
Inclusion Criteria:
- type-2 diabetes
- coronary artery disease
Exclusion Criteria:
- age >80 years
- acute coronary syndrome
- life expectancy <1 year
- unable to give informed consent
,NULL,Major cardiovascular event,Total mortality;sudden cardiac death;Cardiovascular mortality,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-01-31,2011-08-09,2011-08-09,500,Observational,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2010,2014-02-05,TRUE,FALSE,FALSE
26182,NA,DRKS00005313,DRKS00005313,NCT: NA ICTRP: 2013-11-21 DRKS: 2013-11-21,1,NA,NA,1,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no time frame",2,NA,"no AM, no time frame, no measure",NCT: NA ICTRP: 21 DRKS: Tatsächlich 21,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2771-01/13,Systemic versus local inflammation: Analysis of tonsillar T-cell function as a surrogate marker of the immune status in sepsis versus chronic tonsillitis,Systemic versus local inflammation: Analysis of tonsillar T-cell function as a surrogate marker of the immune status in sepsis versus chronic tonsillitis - HTTS ,orlando.guntinas@med.uni-jena.de,orlando.guntinas@med.uni-jena.de,Observational,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Other. Assignment: Parallel. Study design purpose: Basic research/physiological study;,N/A,2013-11-21,2013-09-16,21,Other,"Integriertes Forschungs- und Behandlungszentrum Sepsis und SepsisfolgenKlinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde",NULL,germany,"Intervention 1: Patient with sepsis, tissue sampling of palatine tonsils Intervention 2: Patients with chronic tonsillitis, tissue sampling of palatine tonsils Intervention 3: Patients with tonsil hyperplasia, tissue sampling of palatine tonsils",Inclusion criteria: Group 1 (sepsis patients): adult patients who are asked two weeks after the diagnosis of severe sepsis and / or septic shock and written consent to provide a piece of their tonsils
Group 2 (chronic tonsillitis): adult patients with 3 or more episodes of recurrent acute tonsillitis per year that are scheduled for routine tonsillectomy
Group 3 (tonsil hyperplasia): adult patients without acute or chronic tonsillitis in history that are scheduled for routine tonsillectomy due to rhonchopathy or obstructive sleep apnea syndrome,"Exclusion criteria: Group 1 (sepsis patients): neuromuscular diseases, alcohol abuse, steroid therapy for asthma, COPD and patients likely to die within less than 24 hours, patients after tonsillectomy
Group 2 and 3 (chronic tonsillitis and tonsil hyperplasia): sepsis, immunodeficiency, severe chronic diseases in the medical history","Difference in the T cell response of patients with sepsis, chronic tonsillitis and tonsil hyperplasia regarding activation, proliferation and apoptosis and thereby investigate the existence of T cell specific parameters to systemic and local inflammation","Investigation of the use of the tonsils, as the only available secondary lymphoid organ, for the determination of the immune status of patients with sepsis",,2013-11-21,yes,"Sepsis, unspecified; Chronic tonsillitis; Hypertrophy of tonsils","Arm 1 Patient with sepsis, tissue sampling of palatine tonsils; Arm 2 Patients with chronic tonsillitis, tissue sampling of palatine tonsils; Arm 3 Patients with tonsil hyperplasia, tissue sampling of palatine tonsils",Non-interventional,Non-randomized controlled trial,Open (masking not used),Other,Parallel,N/A,"Difference in the T cell response of patients with sepsis, chronic tonsillitis and tonsil hyperplasia regarding activation, proliferation and apoptosis and thereby investigate the existence of T cell specific parameters to systemic and local inflammation","Investigation of the use of the tonsils, as the only available secondary lymphoid organ, for the determination of the immune status of patients with sepsis",Germany,Medical Center Jena,2013-09-16,Actual,21,2014-01-15,Group 1 (sepsis patients): adult patients who are asked two weeks after the diagnosis of severe sepsis and / or septic shock and written consent to provide a piece of their tonsils
Group 2 (chronic tonsillitis): adult patients with 3 or more episodes of recurrent acute tonsillitis per year that are scheduled for routine tonsillectomy
Group 3 (tonsil hyperplasia): adult patients without acute or chronic tonsillitis in history that are scheduled for routine tonsillectomy due to rhonchopathy or obstructive sleep apnea syndrome
,"Group 1 (sepsis patients): neuromuscular diseases, alcohol abuse, steroid therapy for asthma, COPD and patients likely to die within less than 24 hours, patients after tonsillectomy
Group 2 and 3 (chronic tonsillitis and tonsil hyperplasia): sepsis, immunodeficiency, severe chronic diseases in the medical history
",Systemic versus local inflammation: Analysis of tonsillar T-cell function as a surrogate marker of the immune status in sepsis versus chronic tonsillitis,Recruiting stopped after recruiting started ,"Integriertes Forschungs- und Behandlungszentrum Sepsis und SepsisfolgenKlinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde; Integriertes Forschungs- und Behandlungszentrum Sepsis und SepsisfolgenKlinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde; Integriertes Forschungs- und BehandlungszentrumSepsis und SepsisfolgenKlinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde",orlando.guntinas@med.uni-jena.de; orlando.guntinas@med.uni-jena.de; orlando.guntinas@med.uni-jena.de,"Arm 1 Patient with sepsis, tissue sampling of palatine tonsils; Arm 2 Patients with chronic tonsillitis, tissue sampling of palatine tonsils; Arm 3 Patients with tonsil hyperplasia, tissue sampling of palatine tonsils",2013-09-16,NA,2013-11-21,21,Observational,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2013,NA,FALSE,TRUE,FALSE
24576,NA,DRKS00008173,DRKS00008173,NCT: NA ICTRP: 2015-07-29 DRKS: 2015-07-29,1,NA,NA,1,NA,NA,NA,NA,NA,NA,4,NA,no measure,5,NA,NA,NCT: NA ICTRP: 100 DRKS: Tatsächlich 100,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,U1111-1171-6041;2013-628N-MA,Optimized Response Assessment of Gastrointestinal Stromal Tumors Using Dual-Energy CT: A Prospective Multicenter-Multinational Trail in Patients Undergoing Targeted Therapy with a tyrosine-kinase-inhibitor,Optimized Response Assessment of Gastrointestinal Stromal Tumors Using Dual-Energy CT: A Prospective Multicenter-Multinational Trail in Patients Undergoing Targeted Therapy with a tyrosine-kinase-inhibitor ,mathias.meyer@medma.uni-heidelberg.de,silke.bittorf@umm.de,Interventional,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Treatment;,N/A,2015-07-29,2014-01-01,100,Complete: follow-up continuing,Universitätsklinikum Mannheim,NULL,germany;italy;united kingdom;japan,"Intervention 1: Patients with Gastrointestinal Stromal Tumors undergoing tyrosine kinase inhibitor treatment will be assessed regarding progression-free survival and overall survival within 2 years using the standard response criteria, in particular Response Evaluation Criteria In Solid Tumors, the WHO criteria for response, the tumor lesion volume as well as tumor density (according to Choi). Intervention 2: Patients with Gastrointestinal Stromal Tumors undergoing tyrosine kinase inhibitor treatment will be assessed regarding progression-free survival and overall survival within 2 years using the response criteria, in particular tumor lesion iodine uptake normalised to the aorta and tumor lesion iodine uptake normalised to the portal vein.",Inclusion criteria: All patients being diagnosed with Gastrointestinal Stromal Tumors and undergoing systemic target treatment will be included.,Exclusion criteria: Patients younger than 18 years or with contraindication to a contrast-enhanced CT scan.,Progression-free survival within 2 years.,Overall survival within 4 years.,U1111-1171-6041,2015-07-29,yes,Malignant neoplasm of stomach; Malignant neoplasm of small intestine; Malignant neoplasm of colon,"Arm 1 Patients with Gastrointestinal Stromal Tumors undergoing tyrosine kinase inhibitor treatment will be assessed regarding progression-free survival and overall survival within 2 years using the standard response criteria, in particular Response Evaluation Criteria In Solid Tumors, the WHO criteria for response, the tumor lesion volume as well as tumor density (according to Choi).; Arm 2 Patients with Gastrointestinal Stromal Tumors undergoing tyrosine kinase inhibitor treatment will be assessed regarding progression-free survival and overall survival within 2 years using the response criteria, in particular tumor lesion iodine uptake normalised to the aorta and tumor lesion iodine uptake normalised to the portal vein.",Interventional,Non-randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,N/A,Progression-free survival within 2 years.,Overall survival within 4 years.,Germany; Italy; United Kingdom; Japan,University Medical Center Mannheim; University Medical Center Mailand; University Medical Center Tohoku ; University Medical Center London,2014-01-01,Actual,100,NA,All patients being diagnosed with Gastrointestinal Stromal Tumors and undergoing systemic target treatment will be included.,Patients younger than 18 years or with contraindication to a contrast-enhanced CT scan. ,Optimized Response Assessment of Gastrointestinal Stromal Tumors Using Dual-Energy CT: A Prospective Multicenter-Multinational Trail in Patients Undergoing Targeted Therapy with a tyrosine-kinase-inhibitor,"Recruiting complete, follow-up continuing",Universitätsklinikum Mannheim; Universitätsklinikum Mannheim; Universitätsklinikum Mannheim,[---]*; mathias.meyer@medma.uni-heidelberg.de; silke.bittorf@umm.de,"Arm 1 Patients with Gastrointestinal Stromal Tumors undergoing tyrosine kinase inhibitor treatment will be assessed regarding progression-free survival and overall survival within 2 years using the standard response criteria, in particular Response Evaluation Criteria In Solid Tumors, the WHO criteria for response, the tumor lesion volume as well as tumor density (according to Choi).; Arm 2 Patients with Gastrointestinal Stromal Tumors undergoing tyrosine kinase inhibitor treatment will be assessed regarding progression-free survival and overall survival within 2 years using the response criteria, in particular tumor lesion iodine uptake normalised to the aorta and tumor lesion iodine uptake normalised to the portal vein.",2014-01-01,NA,2015-07-29,100,Interventional,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2014,NA,FALSE,TRUE,FALSE
22220,NA,DRKS00012801,DRKS00012801,NCT: NA ICTRP: 2017-09-04 DRKS: 2017-09-04,1,NA,NA,1,NA,NA,criteria for Stenose,2,NA,NA,3,NA,"no AM, no measure",4,NA,no AM,NCT: NA ICTRP: 110 DRKS: Tatsächlich 110,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,35/17,"Comparison of imaging techniques (MDCT, 3D-TEE, fusion) to support procedures for Transcatheter Aortic Valve Replacement (TAVR)","Comparison of imaging techniques (MDCT, 3D-TEE, fusion) to support procedures for Transcatheter Aortic Valve Replacement (TAVR) ",saskia.meissler@med.ovgu.de,saskia.meissler@med.ovgu.de,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Diagnostic;,N/A,2017-09-04,2017-08-07,110,Recruiting,Klinik für Kardiologie und Angiologie der Uniklinik Magdeburg,NULL,germany,Intervention 1: Intraindividual comparison of 3D transesophageal echocardiography measurements and MSCT (multidetector computed tomography) measurements for the selection of the appropriate valve prosthesis before transvascular transcatheter aortic valve replacement (TAVR),Inclusion criteria: Severe aortic stenosis and positive heartteam vote for TAVR,"Exclusion criteria: <18 years; operational coronary heart disease; acute myocardial infarction; TIA, PRIND, Apoplex in the last 6 months, no patient consent",Non-inferiority of the annulus diameter measurement in the 3D TEE ultrasound vs MSCT (Multidetector computed tomography). The measurement of the diameter using 3D TEE and CT is performed before intervention.,"Exploratory data analysis of the following parameters:
- Height of the coronary arteries, sinus of valsalva diameter, sinutubular junction diameter,
(the measurement of these parameters using CT and TEE are performed before intervention).
- angulation angle (the angle is measured by using CT before intervention and by fusion periinterventionally).",,2017-09-04,yes,Aortic (valve) stenosis,Arm 1 Intraindividual comparison of 3D transesophageal echocardiography measurements and MSCT (multidetector computed tomography) measurements for the selection of the appropriate valve prosthesis before transvascular transcatheter aortic valve replacement (TAVR),Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,Non-inferiority of the annulus diameter measurement in the 3D TEE ultrasound vs MSCT (Multidetector computed tomography). The measurement of the diameter using 3D TEE and CT is performed before intervention.,"Exploratory data analysis of the following parameters:
- Height of the coronary arteries, sinus of valsalva diameter, sinutubular junction diameter,
(the measurement of these parameters using CT and TEE are performed before intervention).
- angulation angle (the angle is measured by using CT before intervention and by fusion periinterventionally).",Germany,University Medical Center Magdeburg,2017-08-07,Actual,110,NA,Severe aortic stenosis and positive heartteam vote for TAVR
,"<18 years; operational coronary heart disease; acute myocardial infarction; TIA, PRIND, Apoplex in the last 6 months, no patient consent","Comparison of imaging techniques (MDCT, 3D-TEE, fusion) to support procedures for Transcatheter Aortic Valve Replacement (TAVR)",Recruiting ongoing,Klinik für Kardiologie und Angiologie der Uniklinik Magdeburg; Uniklinik Magdeburg; Klinik für Kardiologie und Angiologie der Uniklinik Magdeburg,[---]*; saskia.meissler@med.ovgu.de; saskia.meissler@med.ovgu.de,Arm 1 Intraindividual comparison of 3D transesophageal echocardiography measurements and MSCT (multidetector computed tomography) measurements for the selection of the appropriate valve prosthesis before transvascular transcatheter aortic valve replacement (TAVR),2017-08-07,NA,2017-09-04,110,Interventional,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2017,NA,FALSE,TRUE,FALSE
28129,NA,DRKS00000276,DRKS00000276,NCT: NA ICTRP: 2010-11-17 DRKS: 2010-11-17,1,1,NA,1,1,a,criteria more specific in paper,2,1,NA,5,1,NA,4,1,no measure,NCT: NA ICTRP: 892 DRKS: Tatsächlich 892,902,1,NA,NA,NA,"Observer blinded, registered as open",NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1371/journal.pone.0202133,2018-03-13,2011-12-23,NA,2011-04-30,2013-06-30,Interventional,Effect of the Biomarker Copeptin in Managing Patients With Suspected Acute Coronary Syndrome (ACS),The Effect of Integrating the Biomarker Copeptin Into the Process of Managing Patients With Suspected ACS,Completed,N/A,902,Actual,"Charite University, Berlin, Germany",Rate of major adverse cardiac events (MACE) within 30 days Copeptin vs. Control arm.,Proportion of patients in whom coronary angiography (CA) is performed Copeptin vs. Control arm.;Rate of ALL major adverse cardiac events (MACE);Patient satisfaction regarding management within the ED/CPU;Length of hospital stay,DRKS00000276;U1111-1118-1665;Charite-BiC-8,Effect of the Biomarker Copeptin in Managing Patients With Suspected Acute Coronary Syndrome (ACS),The Effect of Integrating the Biomarker Copeptin Into the Process of Managing Patients With Suspected ACS,,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic",N/A,2011-10-25,2011-04-20,902,Completed,"Charite University, Berlin, Germany","Kerckhoff-Klinik Bad Nauheim;Heidelberg University;Universitätsklinikum Hamburg-Eppendorf;Wilhelminenspital Vienna;University Hospital, Basel, Switzerland",austria;germany;switzerland;austria;germany;switzerland,Behavioral: Discharge home,"
Inclusion Criteria:
- Typical chest pain (with or without ECG-changes, but no ST-elevation)suggestive of
unstable angina or non-ST-elevated myocardial infarction (NSTEMI)
- Troponin negative at admission according to the current clinical practice Patient
willing and able to give written informed consent
Exclusion Criteria:
- Patients with ST-elevation myocardial infarction (STEMI)
- Continuing chest pain or recurrent episodes of chest pain under therapy
- High-risk patients with suspected ACS who need to be hospitalized for reasons
independent of their initial troponin result
- Patients who need to be hospitalized for other medical reasons
- Patients in need of urgent life-saving interventions
- Patients under 18 years of age
- Patients with a life expectancy < 6 months
- Patients with any condition that leads the treating physician to not consider the
patient eligible for the trial
",NULL,Rate of major adverse cardiac events (MACE) within 30 days Copeptin vs. Control arm.,Proportion of patients in whom coronary angiography (CA) is performed Copeptin vs. Control arm.;Rate of ALL major adverse cardiac events (MACE);Patient satisfaction regarding management within the ED/CPU;Length of hospital stay,U1111-1118-1665; NCT01498731,2010-11-17,yes,Angina pectoris; Ischaemic heart diseases,"Arm 1 Experimental Arm:
Patients who test negative for Copeptin at admission will be considered low-risk and will be discharged home without further interventions.
To secure the patients safety they will be transferred into our co-operating network of resident cardiologists using the software ""Praxis-connect"" i.e. these patients will be discharged with an electronically booked appointment to see a cardiologist preferably the next day (but latest within the next three days). In case of any findings suggestive of acute coronary syndrome or worsening of the patient's condition, the patient will immediately be re-admitted to our Emergency Room.
Patients who test positive for Copeptin will be treated as by standard practise.; Arm 2 Control Arm:
Patients will be managed as by standard practice abiding current guidelines for the management of patients with suspected ACS. ",Interventional,Randomized controlled trial,Open (masking not used),Other,Parallel,N/A,"Safety effectivity endpoint: Proportion of MACE (all- cause death or survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III)) within 30 days Copeptin vs. Control arm (non-inferiority).","Efficiency endpoint of proportion of patients in whom coronary angiography is performed copeptin vs. control arm.
Proportion of patients requiring PCI due to their findings in cardiac catheterization copeptin vs. control arm. (Assessment of Copeptin as a rule-in marker)
Further secondary endpoints evaluate efficacy, safety, cost effectiveness and patient satisfaction of the new process including length of stay in the hospital.
All-cause death, survived sudden cardiac arrest, myocardial infarction, re-hospitalisation for acute coronary syndrome, acute unplanned PCI, coronary artery bypass grafting (CABG) and documented life-threatening arrhythmias (VF, VT, AV-block III) at 30 and 90 days.",Germany; Austria; Switzerland,University Medical Center Berlin; University Medical Center Heidelberg; Medical Center Bad Nauheim; University Medical Center Hamburg; Medical Center Wien; University Medical Center Basel,2011-04-13,Actual,892,2013-06-24,"Admission to the Emergency Department with symptoms consistent with ACS:
- Typical chest pain (with or without ECG-changes, but no ST-elevation) suggestive of unstable angina or non-ST-elevated myocardial infarction (NSTEMI)
- Troponin negative at admission according to the current clinical practice
Patient willing and able to give written informed consent
",Patients with ST-elevation myocardial infarction (STEMI)
Continuing chest pain or recurrent episodes of chest pain under therapy
High-risk patients with suspected ACS who need to be hospitalized for reasons independent of their initial troponin result
Patients who need to be hospitalized for other medical reasons
Patients in need of urgent life-saving interventions
Patients under 18 years of age
Patients with a life expectancy < 6 months
Patients with any condition that leads the treating physician to not consider the patient eligible for the trial
,Biomarkers in Cardiology (BIC) -8: The effect of integrating the biomarker Copeptin into the process of managing patients with suspected ACS ,"Recruiting complete, follow-up complete","Charité Berlin, Arbeitsbereich Notfallmedizin CVK und CCM; Charité - Universitätsmedizin Berlin
Campus Virchow Klinkum
Med. Klinik m.S. Kardiologie
Internistische Notaufnahme; Charité - Universitätsmedizin Berlin
Campus Virchow Klinikum
Med. Klinik m.S. Kardiologie
Internistische Notaufnahme",martin.moeckel@charite.de; julia.searle@charite.de; julia.searle@charite.de,"Arm 1 Experimental Arm:
Patients who test negative for Copeptin at admission will be considered low-risk and will be discharged home without further interventions.
To secure the patients safety they will be transferred into our co-operating network of resident cardiologists using the software ""Praxis-connect"" i.e. these patients will be discharged with an electronically booked appointment to see a cardiologist preferably the next day (but latest within the next three days). In case of any findings suggestive of acute coronary syndrome or worsening of the patient's condition, the patient will immediately be re-admitted to our Emergency Room.
Patients who test positive for Copeptin will be treated as by standard practise.; Arm 2 Control Arm:
Patients will be managed as by standard practice abiding current guidelines for the management of patients with suspected ACS. ",2011-04-13,2011-10-25,2010-11-17,892,Interventional,TRUE,TRUE,FALSE,TRUE,FALSE,TRUE,TRUE,TRUE,TRUE,TRUE,2011,NA,TRUE,TRUE,FALSE
25316,NA,DRKS00006737,DRKS00006737,NCT: NA ICTRP: 2014-11-14 DRKS: 2014-11-14,1,NA,NA,0,NA,NA,Missing: Patients assigned to that specific emergency unit,NA,NA,NA,2,NA,"no time frame (duration of ""Untersuchungszeitraum"")",0,NA,unclear to this assesor how missed indications can be recorded,NCT: NA ICTRP: 3746 DRKS: Tatsächlich 3746,NA,1,NA,NA,NA,NA,NA,NA,NA,0,Outcome missing,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NULL,Tranexamic acid for pre-hospital lifethreatening bleeding: a retrospective analysis in an urban EMS,Tranexamic acid for pre-hospital lifethreatening bleeding: a retrospective analysis in an urban EMS ,Gaier_G@kreiskliniken-reutlingen.de,Gaier_G@kreiskliniken-reutlingen.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Treatment;,N/A,2014-11-14,2014-09-01,3746,Complete: follow-up complete,Klinikum am Steinenberg Reutlingen,NULL,germany,"Intervention 1: Application of TXA for given indications such as severe trauma, severe gynecological bleeding, GI bleeding, TE rebleeding.
We analyze emergency medical protocols for appropriate applications.
To get indicators for other potential indications, we match possible indications with clinical laboratory data and medical reports.",Inclusion criteria: none,Exclusion criteria: none,Number and indication of pre-hospital TXA applications during the investigation period,"Possible, respectively missed indications for pre-hospital TXA application",,2014-11-14,yes,relevant pre-hospital bleeding ,"Arm 1 Application of TXA for given indications such as severe trauma, severe gynecological bleeding, GI bleeding, TE rebleeding.
We analyze emergency medical protocols for appropriate applications.
To get indicators for other potential indications, we match possible indications with clinical laboratory data and medical reports.",Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,Number and indication of pre-hospital TXA applications during the investigation period,"Possible, respectively missed indications for pre-hospital TXA application",Germany,other Reutlingen,2014-09-01,Actual,3746,2014-11-01,none,none,Tranexamic acid for pre-hospital lifethreatening bleeding: a retrospective analysis in an urban EMS,"Recruiting complete, follow-up complete",Klinikum am Steinenberg Reutlingen; Klinikum am Steinenberg Reutlingen; Klinikum am Steinenberg Reutlingen,[---]*; Gaier_G@kreiskliniken-reutlingen.de; Gaier_G@kreiskliniken-reutlingen.de,"Arm 1 Application of TXA for given indications such as severe trauma, severe gynecological bleeding, GI bleeding, TE rebleeding.
We analyze emergency medical protocols for appropriate applications.
To get indicators for other potential indications, we match possible indications with clinical laboratory data and medical reports.",2014-09-01,NA,2014-11-14,3746,Observational,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2014,NA,FALSE,TRUE,FALSE
21649,NA,DRKS00013793,DRKS00013793,NCT: NA ICTRP: 2018-03-01 DRKS: 2018-03-01,1,NA,NA,1,NA,NA,NA,2,NA,NA,4,NA,no AM,3,NA,"no AM, no details about measure",NCT: NA ICTRP: 130 DRKS: Tatsächlich 130,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Studienprotokoll,https://doi.org/10.1186/s12877-018-1000-3,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,ISRCTN59052178;FSV 18/06,Individualized music for people with dementia - Improvement of quality of life and social participation for people with dementia in institutional care,Individualized music for people with dementia - Improvement of quality of life and social participation for people with dementia in institutional care ,gabriele.wilz@uni-jena.de,lisette.weise@uni-jena.de,Interventional,Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Control group receives no treatment. Assignment: Parallel. Study design purpose: Supportive care;,II,2018-03-01,2018-02-21,130,Complete: follow-up complete,Friedrich-Schiller-Universität Jena,NULL,germany,"Intervention 1: Over a period of 6 weeks, the intervention group participants will listen to their individualized music playlist through headphones every other day for 20 minutes in the presence of employees of the nursing home or project staff. Observation of behavior will be conducted by the project staff every other week before, during and after the music intervention. Intervention 2: The control group receives standard care. The observation of behavior will be conducted with the same frequency and duration as in the intervention group.","Inclusion criteria: Care-dependent people with a dignosed dementia, living in a nursing home",Exclusion criteria: hearing problems,"1. Quality of life
a) external assessment by the nursing staff at all four assessment points: mood, sleep quality, social participation (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), depressive symptoms (assessed with the Cornell Scale for Depression in Dementia, CSDD)
b) Observation of behavior will be conducted three times during the intervention period using an adapted rating scale: emotional and motor changes (facial expression, body movement, other (positive) reactions), activation regarding social participation
2. Problem behavior:
a) external assessment by the nursing staff at all four assessment points: resistance to care (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), problem behavior/behavioral syndromes (assessed with the Cohen-Mansfield Agitation Inventory (CMAI) and the Nurses Observation Scale for Geriatric Patients (NOSGER II)
b) Observation of behavior (see above): appearance of problem behavior or other negative reactions
Assessment points:
6 weeks before start of the intervention (T0)
beginning of the intervention (T1)
directly after the intervention (T2)
follow-up 6 weeks after the end of the intervention (T3)","At the second assessment point, the nursing staff will evaluate the acceptance and applicability of the intervention using a self-developed questionnaire",ISRCTN59052178,2018-03-01,yes,Dementia in Alzheimer disease; Vascular dementia; Dementia in other diseases classified elsewhere; Unspecified dementia,"Arm 1 Over a period of 6 weeks, the intervention group participants will listen to their individualized music playlist through headphones every other day for 20 minutes in the presence of employees of the nursing home or project staff. Observation of behavior will be conducted by the project staff every other week before, during and after the music intervention.
; Arm 2 The control group receives standard care. The observation of behavior will be conducted with the same frequency and duration as in the intervention group.
",Interventional,Randomized controlled trial,Open (masking not used),Control group receives no treatment,Parallel,II,"1. Quality of life
a) external assessment by the nursing staff at all four assessment points: mood, sleep quality, social participation (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), depressive symptoms (assessed with the Cornell Scale for Depression in Dementia, CSDD)
b) Observation of behavior will be conducted three times during the intervention period using an adapted rating scale: emotional and motor changes (facial expression, body movement, other (positive) reactions), activation regarding social participation
2. Problem behavior:
a) external assessment by the nursing staff at all four assessment points: resistance to care (assessed with a visual analogue scale, based on Wilz & Soellner, 2015), problem behavior/behavioral syndromes (assessed with the Cohen-Mansfield Agitation Inventory (CMAI) and the Nurses Observation Scale for Geriatric Patients (NOSGER II)
b) Observation of behavior (see above): appearance of problem behavior or other negative reactions
Assessment points:
6 weeks before start of the intervention (T0)
beginning of the intervention (T1)
directly after the intervention (T2)
follow-up 6 weeks after the end of the intervention (T3)
","At the second assessment point, the nursing staff will evaluate the acceptance and applicability of the intervention using a self-developed questionnaire",Germany,other Weimar; other Erfurt; other Weimar; other Erfurt,2018-02-21,Actual,130,2020-06-02,"Care-dependent people with a dignosed dementia, living in a nursing home",hearing problems,Individualized music for people with dementia - Improvement of quality of life and social participation for people with dementia in institutional care,"Recruiting complete, follow-up complete",Friedrich-Schiller-Universität Jena; Friedrich-Schiller-Universität Jena; Friedrich-Schille-Universität Jena; Friedrich-Schiller-Universität Jena,[---]*; gabriele.wilz@uni-jena.de; lisette.weise@uni-jena.de; elisabeth.jakob@uni-jena.de,"Arm 1 Over a period of 6 weeks, the intervention group participants will listen to their individualized music playlist through headphones every other day for 20 minutes in the presence of employees of the nursing home or project staff. Observation of behavior will be conducted by the project staff every other week before, during and after the music intervention.
; Arm 2 The control group receives standard care. The observation of behavior will be conducted with the same frequency and duration as in the intervention group.
",2018-02-21,NA,2018-03-01,130,Interventional,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2018,NA,FALSE,TRUE,FALSE
21624,NA,DRKS00013568,DRKS00013568,NCT: NA ICTRP: 2018-03-07 DRKS: 2018-03-07,1,1,NA,1,1,NA,NA,NA,NA,NA,3,1,"no AM, no measure",0,NA,"insufficient, too broad",NCT: NA ICTRP: 200 DRKS: Tatsächlich 200,74,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome (too unspecific),ganzer Artikel,10.1097/RLI.0000000000000590,2019-02-06,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,EA1/056/16,Development and validation of ultrasound elastography of the aorta for assessment of the central cardiovascular system,Development and validation of ultrasound elastography of the aorta for assessment of the central cardiovascular system - USEAo ,thomas.elgeti@charite.de,lars-arne.schaafs@charite.de,Observational,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Other. Assignment: Other. Study design purpose: Basic research/physiological study;,N/A,2018-03-07,2018-01-01,200,Recruiting,"Klinik und Hochschulambulanz für Radiologie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin",NULL,germany,Intervention 1: Patients with diagnosed arterial hypertension. Patients undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta. Intervention 2: Healthy volunteers. Volunteers undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta.,Inclusion criteria: History of arterial hypertension or healthy volunteers,"Exclusion criteria: pregnancy, acute myocardial infarction or stroke within 14 days before the examination",The primary outcome is the successful measurement of regional aortic stiffness in healthy volunteers and patients with the help of ultrasound elastograpyh. This is a feasibility study with the purpose of introducing a new diagnostic parameter.,Derivation of diagnostic parameters. Comparison of derived parameters with established methods.,,2018-03-07,yes,"Hypertensive diseases; Diseases of arteries, arterioles and capillaries",Arm 1 Patients with diagnosed arterial hypertension. Patients undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta.; Arm 2 Healthy volunteers. Volunteers undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta.,Non-interventional,Non-randomized controlled trial,Open (masking not used),Other,Other,N/A,The primary outcome is the successful measurement of regional aortic stiffness in healthy volunteers and patients with the help of ultrasound elastograpyh. This is a feasibility study with the purpose of introducing a new diagnostic parameter.,Derivation of diagnostic parameters. Comparison of derived parameters with established methods.,Germany,Medical Center Berlin,2018-01-01,Actual,200,NA,History of arterial hypertension or healthy volunteers,"pregnancy, acute myocardial infarction or stroke within 14 days before the examination",Development and validation of ultrasound elastography of the aorta for assessment of the central cardiovascular system,Recruiting ongoing,"Klinik und Hochschulambulanz für Radiologie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin; Klinik und Hochschulambulanz für Radiologie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin; Klinik und Hochschulambulanz für Radiologie, Campus Benjamin Franklin, Charité-Universitätsmedizin Berlin",thomas.elgeti@charite.de; thomas.elgeti@charite.de; lars-arne.schaafs@charite.de,Arm 1 Patients with diagnosed arterial hypertension. Patients undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta.; Arm 2 Healthy volunteers. Volunteers undergo measurements of pulse wave velocity and peripheral blood pressure as well as ultrasound elastography of the aorta.,2018-01-01,NA,2018-03-07,200,Observational,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2018,NA,FALSE,TRUE,FALSE
25187,NA,DRKS00006256,DRKS00006256,NCT: NA ICTRP: 2015-01-09 DRKS: 2015-01-09,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure",4,NA,no AM,NCT: NA ICTRP: 960 DRKS: Tatsächlich 960,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,Studienprotokoll,https://doi.org/10.1186/s12875-016-0447-6,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,U1111-1164-7207;318/13,Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction,Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction - IDrug ,kkastenm@uni-bonn.de,kkastenm@uni-bonn.de,Observational,Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject). Control: Other. Assignment: Parallel. Study design purpose: Prevention;,N/A,2015-01-09,2014-09-29,960,Recruiting,Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM),NULL,germany,"Intervention 1: The following parameters will be included in the individualized pharmacotherapeutical risk information:
- genetical analysis (CYP2C9, CYP2C19, VCORC1)
- drug- drug interaction test
- liver values and other lab values
There will be no given direction to change the drug therapy. The doctor can act as he thinks is best for the patient. Every 3 month (3 times ) there will be consultations with the patient, where the patients will be ask about their general health. The patients will be ask the following questions, just to list a few:
- number of sick certifcates
- number of specialist's referral
- number of admissions to a hosital
- accidents (traffic, in the house, at work,....)
- operations
- invasive examination (e.g. catheter)
- allergic reactions
- headache
- nausea
-......... Intervention 2: Patients that get the standardized risk information will get informed in detail about their liver values and other values, that were measured in the lab. Also they will get detailed information again about the meaning of oral anticoagulation. The treatment will be according to current medical standards including additional standardized information on risk factors for adverse drug effects. Every 3 month ( 3 times altogteher) the patients are ask for their health status. the following paramters are being documented:
- number of sick certifcates
- number of specialist's referral
- number of admissions to a hosital
- accidents (traffic, in the house, at work,....)
- severe adverse drug reactions
- Number of hospital admissions due to adverse drug effects
- Number of specialist consultations due to problems in drug therapy
- Number of medication changes during obsevation period
- etc. ....","Inclusion criteria: multimorbidity, therapy with oral anticoagulation, minimum of one additional medication over a longer period of time, can give written consent to take part in the study","Exclusion criteria: is not able to give consent ot take part in that study, is not able to understand and/or fill in the questionaire SF-36 and other forms",Bleeding occurence or occurence of a thromboembolic event during the observation period of 9 month,"morbidity: serious adverse drug reaction during the observation period of 9 month. Number of hospitailzation due to serious adverse drug reaction. Number of specialist's referral due do problems with the medication. Number of change in medication during the observation period of 9 month.
mortality: number of death during the observation period of 9 month.
Effectiveness: qualtiy of life (SF-36; 3,6, and 9 month after start of the study). Cost of medication and of potantil additional doctor’s visit. cost-benefit analysis (that takes mobidity and mortality into account)",U1111-1164-7207,2015-01-09,yes,"coagulation problems,
Bleeding events,
thromboembolic events; [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]; [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]; [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]; [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]","Arm 1 The following parameters will be included in the individualized pharmacotherapeutical risk information:
- genetical analysis (CYP2C9, CYP2C19, VCORC1)
- drug- drug interaction test
- liver values and other lab values
There will be no given direction to change the drug therapy. The doctor can act as he thinks is best for the patient. Every 3 month (3 times ) there will be consultations with the patient, where the patients will be ask about their general health. The patients will be ask the following questions, just to list a few:
- number of sick certifcates
- number of specialist's referral
- number of admissions to a hosital
- accidents (traffic, in the house, at work,....)
- operations
- invasive examination (e.g. catheter)
- allergic reactions
- headache
- nausea
-.........
; Arm 2 Patients that get the standardized risk information will get informed in detail about their liver values and other values, that were measured in the lab. Also they will get detailed information again about the meaning of oral anticoagulation. The treatment will be according to current medical standards including additional standardized information on risk factors for adverse drug effects. Every 3 month ( 3 times altogteher) the patients are ask for their health status. the following paramters are being documented:
- number of sick certifcates
- number of specialist's referral
- number of admissions to a hosital
- accidents (traffic, in the house, at work,....)
- severe adverse drug reactions
- Number of hospital admissions due to adverse drug effects
- Number of specialist consultations due to problems in drug therapy
- Number of medication changes during obsevation period
- etc. ....
",Non-interventional,Randomized controlled trial,Blinded,Other,Parallel,N/A,Bleeding occurence or occurence of a thromboembolic event during the observation period of 9 month,"morbidity: serious adverse drug reaction during the observation period of 9 month. Number of hospitailzation due to serious adverse drug reaction. Number of specialist's referral due do problems with the medication. Number of change in medication during the observation period of 9 month.
mortality: number of death during the observation period of 9 month.
Effectiveness: qualtiy of life (SF-36; 3,6, and 9 month after start of the study). Cost of medication and of potantil additional doctor’s visit. cost-benefit analysis (that takes mobidity and mortality into account)
",Germany,Doctor's Practice Rhein-Sieg Kreis,2014-09-29,Actual,960,NA,"multimorbidity, therapy with oral anticoagulation, minimum of one additional medication over a longer period of time, can give written consent to take part in the study ","is not able to give consent ot take part in that study, is not able to understand and/or fill in the questionaire SF-36 and other forms",Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction,Recruiting ongoing,"Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM); Universitätsklinikum Bonn, Institut für Hausarztmedizin; Universitätsklinikum Bonn, Institut für Hausarztmedizin",Julia.Stingl@bfarm.de; kkastenm@uni-bonn.de; kkastenm@uni-bonn.de,"Arm 1 The following parameters will be included in the individualized pharmacotherapeutical risk information:
- genetical analysis (CYP2C9, CYP2C19, VCORC1)
- drug- drug interaction test
- liver values and other lab values
There will be no given direction to change the drug therapy. The doctor can act as he thinks is best for the patient. Every 3 month (3 times ) there will be consultations with the patient, where the patients will be ask about their general health. The patients will be ask the following questions, just to list a few:
- number of sick certifcates
- number of specialist's referral
- number of admissions to a hosital
- accidents (traffic, in the house, at work,....)
- operations
- invasive examination (e.g. catheter)
- allergic reactions
- headache
- nausea
-.........
; Arm 2 Patients that get the standardized risk information will get informed in detail about their liver values and other values, that were measured in the lab. Also they will get detailed information again about the meaning of oral anticoagulation. The treatment will be according to current medical standards including additional standardized information on risk factors for adverse drug effects. Every 3 month ( 3 times altogteher) the patients are ask for their health status. the following paramters are being documented:
- number of sick certifcates
- number of specialist's referral
- number of admissions to a hosital
- accidents (traffic, in the house, at work,....)
- severe adverse drug reactions
- Number of hospital admissions due to adverse drug effects
- Number of specialist consultations due to problems in drug therapy
- Number of medication changes during obsevation period
- etc. ....
",2014-09-29,NA,2015-01-09,960,Observational,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,2014,NA,FALSE,TRUE,FALSE
22868,NA,DRKS00011712,DRKS00011712,NCT: NA ICTRP: 2017-02-06 DRKS: 2017-02-06,1,1,NA,1,1,NA,NA,NA,NA,NA,4,0,"no AM; Minimal differences between cutpoints in published paper and in register: Acromionslope >=25,7°; Acromionindex >=0,73 vs. acromion slope 25.0° or more, AI 0,75 or more.",1,1,"no AM, no metric, no time frame, no measure",NCT: NA ICTRP: 60 DRKS: Tatsächlich 60,50,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.jor.2020.03.035,2020-02-07,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,3460-2017,Calcifying tendinitis - evaluation of the prevalence of a coincidental outletimpingement analyzing radiological and intraoperative criteria,Calcifying tendinitis - evaluation of the prevalence of a coincidental outletimpingement analyzing radiological and intraoperative criteria ,lucia.braun-munzinger@krh.eu,lucia.braun-munzinger@krh.eu,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Diagnostic;,N/A,2017-02-06,2017-02-02,60,Complete: follow-up complete,"Klinik für Orthopädie, Unfallchirurgie und Sportmedizin - Klinikum Agnes Karll Laatzen - Klinikum Region Hannover",NULL,germany,"Intervention 1: This prospective descriptive observational study evaluates the prevalence of simultaneous outletimpingement in patients with calcifying tendinitis, considering either the pre- and postoperative x-rays and also standardized intraoperative views from the shoulder arthroscopy of the next 60 patients with calcifying tendinitis which proved refractory to conservative treatment and who will be treated with shoulder arthroscopy in our clinic according to our standard treatment. The intraoperative subacromial views will be taken before and after the (as performed as a standard procedure in our clinic in these patients) arthroscopic subacromial decompression.
For an evaluation of the outcome of our patients, they will get to fill out the established constant score-patient-questionnaire for self-evaluation; 3-6 months after the operation, we will do a telephone interview using the same questionnaire. In addition, we will evaulate the radiologic extent of removal of the calcification when intraoperative x-ray is used. We use intraoperative x-ray as a standard procedure during operations for calcifying tendinitis to be able to remove as much of the calcification as possible and to be able to definitely find and open all the calcifications.
50 of the patients that we planned for the study had complete data sets.
During the study, we decided to add a second follow-up after a longer period of 1-2 years to increase the validity of the clinical outcome.",Inclusion criteria: - patients with calcifying tendinitis which has proven refractory to conservative treatment and who are treated with shoulder arthroscopy in our clinic
- minimum age 18 years
- no maximum age,Exclusion criteria: - lack of consentability
- lack of consent for participation
- incomplete or nonevaluable data
- preoperative spontaneous resorption of the calcification
- relevant additional intraoperative pathologies
- reoperation,"Evaluation of the prevalence of a conincident outletimpingement in patients with calcifying tendinitis: - classification of the x-rays according to Bigliani, acromial index, acromial slope (Bigliani/Kitay) and lateral acromion angle -> definition of an outletimpingement as follows: Type II or III of the Bigliani classification; acromial slope >= 25,7%; acromial index >= 0,73; lateral acromial angle <= 83°. As we have to expect also suboptimal radiographs, e.g. for projection errors in limited recording condition (the patients participating in the study are not supposed to have extra x-rays done if an x-ray comes out as suboptimal), one fulfilled criteria of those mentioned above is sufficient for the definition of a radiological outletimpingement.
- qualitative Rating of the intraoperative arthroscopic views of the subacromial space (view from lateral; evaluation of alignment of the acromial caudal surface compared with a shaver which is inserted from dorsally after cut of the coracoacromial Ligament): a parallel alignment means no impingement; a non-parallel alignment or nudging of the shaver to the caudal surface of the acromion is defined asl intraoperativ outletimpingement.",radiological proof of a change in the calcification in the postoperative x-ray,,2017-02-06,yes,Calcific tendinitis of shoulder; Impingement syndrome of shoulder,"Arm 1 This prospective descriptive observational study evaluates the prevalence of simultaneous outletimpingement in patients with calcifying tendinitis, considering either the pre- and postoperative x-rays and also standardized intraoperative views from the shoulder arthroscopy of the next 60 patients with calcifying tendinitis which proved refractory to conservative treatment and who will be treated with shoulder arthroscopy in our clinic according to our standard treatment. The intraoperative subacromial views will be taken before and after the (as performed as a standard procedure in our clinic in these patients) arthroscopic subacromial decompression.
For an evaluation of the outcome of our patients, they will get to fill out the established constant score-patient-questionnaire for self-evaluation; 3-6 months after the operation, we will do a telephone interview using the same questionnaire. In addition, we will evaulate the radiologic extent of removal of the calcification when intraoperative x-ray is used. We use intraoperative x-ray as a standard procedure during operations for calcifying tendinitis to be able to remove as much of the calcification as possible and to be able to definitely find and open all the calcifications.
50 of the patients that we planned for the study had complete data sets.
During the study, we decided to add a second follow-up after a longer period of 1-2 years to increase the validity of the clinical outcome.",Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Evaluation of the prevalence of a conincident outletimpingement in patients with calcifying tendinitis: - classification of the x-rays according to Bigliani, acromial index, acromial slope (Bigliani/Kitay) and lateral acromion angle -> definition of an outletimpingement as follows: Type II or III of the Bigliani classification; acromial slope >= 25,7%; acromial index >= 0,73; lateral acromial angle <= 83°. As we have to expect also suboptimal radiographs, e.g. for projection errors in limited recording condition (the patients participating in the study are not supposed to have extra x-rays done if an x-ray comes out as suboptimal), one fulfilled criteria of those mentioned above is sufficient for the definition of a radiological outletimpingement.
- qualitative Rating of the intraoperative arthroscopic views of the subacromial space (view from lateral; evaluation of alignment of the acromial caudal surface compared with a shaver which is inserted from dorsally after cut of the coracoacromial Ligament): a parallel alignment means no impingement; a non-parallel alignment or nudging of the shaver to the caudal surface of the acromion is defined asl intraoperativ outletimpingement.",radiological proof of a change in the calcification in the postoperative x-ray,Germany,Medical Center Laatzen,2017-02-02,Actual,60,2019-05-16,- patients with calcifying tendinitis which has proven refractory to conservative treatment and who are treated with shoulder arthroscopy in our clinic
- minimum age 18 years
- no maximum age,- lack of consentability
- lack of consent for participation
- incomplete or nonevaluable data
- preoperative spontaneous resorption of the calcification
- relevant additional intraoperative pathologies
- reoperation,Calcifying tendinitis - evaluation of the prevalence of a coincidental outletimpingement analyzing radiological and intraoperative criteria,"Recruiting complete, follow-up complete","Klinik für Orthopädie, Unfallchirurgie und Sportmedizin - Klinikum Agnes Karll Laatzen - Klinikum Region Hannover; Klinik für Orthopädie, Unfallchirurgie und Sportmedizin - Klinikum Agnes Karll Laatzen - Klinikum Region Hannover; Klinik für Orthopädie, Unfallchirurgie und Sportmedizin - Klinikum Agnes Karll Laatzen - Klinikum Region Hannover",lucia.braun-munzinger@krh.eu; lucia.braun-munzinger@krh.eu; lucia.braun-munzinger@krh.eu,"Arm 1 This prospective descriptive observational study evaluates the prevalence of simultaneous outletimpingement in patients with calcifying tendinitis, considering either the pre- and postoperative x-rays and also standardized intraoperative views from the shoulder arthroscopy of the next 60 patients with calcifying tendinitis which proved refractory to conservative treatment and who will be treated with shoulder arthroscopy in our clinic according to our standard treatment. The intraoperative subacromial views will be taken before and after the (as performed as a standard procedure in our clinic in these patients) arthroscopic subacromial decompression.
For an evaluation of the outcome of our patients, they will get to fill out the established constant score-patient-questionnaire for self-evaluation; 3-6 months after the operation, we will do a telephone interview using the same questionnaire. In addition, we will evaulate the radiologic extent of removal of the calcification when intraoperative x-ray is used. We use intraoperative x-ray as a standard procedure during operations for calcifying tendinitis to be able to remove as much of the calcification as possible and to be able to definitely find and open all the calcifications.
50 of the patients that we planned for the study had complete data sets.
During the study, we decided to add a second follow-up after a longer period of 1-2 years to increase the validity of the clinical outcome.",2017-02-02,NA,2017-02-06,60,Observational,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2017,NA,FALSE,TRUE,FALSE
26806,NA,DRKS00003693,DRKS00003693,NCT: NA ICTRP: 2012-12-05 DRKS: 2012-12-05,1,NA,NA,2,NA,NA,NA,2,NA,NA,1,NA,"no AM, no metric, no time frame, no measure",NA,NA,NA,NCT: NA ICTRP: 200 DRKS: Tatsächlich 200,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,07/2004,ADO CTCL-3 (Tarado): Multicentric therapy protocol for bexarotene (Targretin ®) monotherapy in pretreated CTCL stage =Ib with clear assignment to a EORTC-Diagnosis,ADO CTCL-3 (Tarado): Multicentric therapy protocol for bexarotene (Targretin ®) monotherapy in pretreated CTCL stage =Ib with clear assignment to a EORTC-Diagnosis - Tarado ,MWeichenthal@dermatology.uni-kiel.de,MWeichenthal@dermatology.uni-kiel.de,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Treatment;,IV,2012-12-05,2004-07-01,200,Recruiting,Universitätsklinikum Schleswig-Holstein Campus Kiel,NULL,germany;switzerland,Intervention 1: 150-300mg / m bexarotene daily per os for at least 24 weeks,"Inclusion criteria: 1. Histopathologically documented CTCL stage = Ib and grading by EORTC (Appendix K)
Staging, EORTC classification
2. Pretreatment with PUVA if a continuation of the PUVA is no longer possible or with inadequate response
3. Karnofsky performance status> 60%
4. Age = 18 years
5. Adequate organ function (blood count, liver, kidney, cardiac function, electrolytes, lipids)
6. Neg. Pregnancy test, efficient contraception in male and female patients (bexarotene could lead to decreased efficacy of hormonal contraceptives)
7. No other active malignancy
8. No topical chemotherapy, photopheresis or interferon treatment to 28 days prior to study entry
9. No topical treatment (steroids, tar-bath), superficial radiotherapy, treatment with other retinoids or beta-carotene two weeks ago baseline *
10. No serious systemic disease or infection at study entry
11. No participation in another study in the last 14 days prior to study entry
12. No pre-treatment with Targretin
13. Lack of psychological, familial, sociological or geographical obstacles that hinder the study protocol or the follow-up control
14. No contraindications to treatment with bexarotene (known hypersensitivity to retinoids, hypervitaminosis A, status after pancreatitis, alcohol abuse, drugs that can be toxic to the pancreas or increase lipid levels, uncontrolled diabetes mellitus, uncontrolled (thyroid disorder)
15. A signed consent of the patient
*Continuous topical steroid applications before and during treatment withTargretin","Exclusion criteria: 1. Mucosal or ocular melanoma melanoma
2. Intransitmetastasen
3. Other adjuvant therapy (systemic therapy with an immunomodulator of a previous operation is allowed, provided that the last dose at least 30 days earlier; prior radiotherapy before lymphadenectomy is allowed)
4. Autoimmune disorders (vitiligo außgenommen)
5. Immunodeficiency
6. Other malignancies (excluding carcinoma in situ of the cervix or remission over 5 years)
7. Uncontrolled bleeding",Effectiveness of bexarotene monotherapy in various defined CTCL subtypes,NULL,,2012-12-05,yes,TCELLLYMPHOMA; Peripheral and cutaneous T-cell lymphomas,Arm 1 150-300mg / m bexarotene daily per os for at least 24 weeks,Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),IV,Effectiveness of bexarotene monotherapy in various defined CTCL subtypes,n/a,Germany; Switzerland,University Medical Center Freiburg im Breisgau,2004-07-01,Actual,200,NA,"1. Histopathologically documented CTCL stage ≥ Ib and grading by EORTC (Appendix K)
Staging, EORTC classification
2. Pretreatment with PUVA if a continuation of the PUVA is no longer possible or with inadequate response
3. Karnofsky performance status> 60%
4. Age ≥ 18 years
5. Adequate organ function (blood count, liver, kidney, cardiac function, electrolytes, lipids)
6. Neg. Pregnancy test, efficient contraception in male and female patients (bexarotene could lead to decreased efficacy of hormonal contraceptives)
7. No other active malignancy
8. No topical chemotherapy, photopheresis or interferon treatment to 28 days prior to study entry
9. No topical treatment (steroids, tar-bath), superficial radiotherapy, treatment with other retinoids or beta-carotene two weeks ago baseline *
10. No serious systemic disease or infection at study entry
11. No participation in another study in the last 14 days prior to study entry
12. No pre-treatment with Targretin
13. Lack of psychological, familial, sociological or geographical obstacles that hinder the study protocol or the follow-up control
14. No contraindications to treatment with bexarotene (known hypersensitivity to retinoids, hypervitaminosis A, status after pancreatitis, alcohol abuse, drugs that can be toxic to the pancreas or increase lipid levels, uncontrolled diabetes mellitus, uncontrolled (thyroid disorder)
15. A signed consent of the patient
*Continuous topical steroid applications before and during treatment withTargretin","1. Mucosal or ocular melanoma melanoma
2. Intransitmetastasen
3. Other adjuvant therapy (systemic therapy with an immunomodulator of a previous operation is allowed, provided that the last dose at least 30 days earlier; prior radiotherapy before lymphadenectomy is allowed)
4. Autoimmune disorders (vitiligo außgenommen)
5. Immunodeficiency
6. Other malignancies (excluding carcinoma in situ of the cervix or remission over 5 years)
7. Uncontrolled bleeding",ADO CTCL-3 (Tarado): Multicentric therapy protocol for bexarotene (Targretin ®) monotherapy in pretreated CTCL stage ≥Ib with clear assignment to a EORTC-Diagnosis,Recruiting ongoing,"Universitätsklinikum Schleswig-Holstein Campus Kiel; Klinik für Dermatologie, Venerologie und Allergologie
Christian-Albrechts-Universität zu Kiel; Klinik für Dermatologie, Venerologie und Allergologie
Christian-Albrechts-Universität zu Kiel",[---]*; MWeichenthal@dermatology.uni-kiel.de; MWeichenthal@dermatology.uni-kiel.de,Arm 1 150-300mg / m bexarotene daily per os for at least 24 weeks,2004-07-01,NA,2012-12-05,200,Interventional,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2004,NA,FALSE,TRUE,FALSE
28531,NA,DRKS00000177,DRKS00000177,NCT: NA ICTRP: 2009-08-28 DRKS: 2009-08-28,1,NA,NA,1,NA,NA,NA,2,NA,Dosage not necessary,3,NA,"No time frame, no measure",1,NA,"No AM, no time frame, no metric, no measure",NCT: NA ICTRP: 25 DRKS: Tatsächlich 25,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,U1111-1111-6900;55/09,Clinical performance of a new temporary crown and bridge material,Clinical performance of a new temporary crown and bridge material ,Bernd.Wöstmann@dentist.med.uni-giessen.de,Bernd.Wöstmann@dentist.med.uni-giessen.de,Interventional,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Historical. Assignment: Other. Study design purpose: Other;,N/A,2009-08-28,2009-08-26,25,Complete: follow-up complete,3M ESPE AG,NULL,germany,"Intervention 1: Temporary restoration made of Protemp 4 Intervention 2: Temporary restoration made of Luxatemp® Automix Plus
Reference data, retrospective comparison","Inclusion criteria: The study will include patients who
are receiving a fixed partial denture or telescopic crowns, are at least 18 years old, have given informed consent","Exclusion criteria: Patients who
have a known allergy to constituents of the materials used, are addicted to medication, alcohol and/ or drugs, are suffering from infectious diseases (hepatitis, HIV, tuberculosis), are suffering from malignant tumors, are undergoing or have undergone radiotherapy, are pregnant or breast feeding, are not giving informed consent, are applying for renewal of a telescopic denture, that is already present",Comparison of the number of failures of the temporary restoration being made of Protemp 4 with the number of failures of temporary restorations being made of Luxatemp® Automix Plus (Reference data),"Colour stability, soft tissue reaction, clinical handling, accuracy of fit, outer shape, plaque accumulation, adhesion to the tooth stump and patients' opinion of the temporary restorations being made of Protemp 4 in comparison to the data of the temporary restorations being made of Luxatemp® Automix Plus (Reference data)",U1111-1111-6900,2009-08-28,no,"Abnormalities of size and form of teeth; Other dental caries; Dental caries, unspecified; Excessive attrition of teeth; Abrasion of teeth","Arm 1 Temporary restoration made of Protemp 4; Arm 2 Temporary restoration made of Luxatemp® Automix Plus
Reference data, retrospective comparison",Interventional,Non-randomized controlled trial,Open (masking not used),Historical,Other,N/A,Comparison of the number of failures of the temporary restoration being made of Protemp 4 with the number of failures of temporary restorations being made of Luxatemp® Automix Plus (Reference data),"Colour stability, soft tissue reaction, clinical handling, accuracy of fit, outer shape, plaque accumulation, adhesion to the tooth stump and patients' opinion of the temporary restorations being made of Protemp 4 in comparison to the data of the temporary restorations being made of Luxatemp® Automix Plus (Reference data)",Germany,,2009-08-26,Actual,25,2010-03-08,"The study will include patients who
are receiving a fixed partial denture or telescopic crowns, are at least 18 years old, have given informed consent","Patients who
have a known allergy to constituents of the materials used, are addicted to medication, alcohol and/ or drugs, are suffering from infectious diseases (hepatitis, HIV, tuberculosis), are suffering from malignant tumors, are undergoing or have undergone radiotherapy, are pregnant or breast feeding, are not giving informed consent, are applying for renewal of a telescopic denture, that is already present",Clinical performance of a new temporary crown and bridge material,"Recruiting complete, follow-up complete","3M ESPE AG; Poliklinik für zahnärztliche Prothetik am Zentrum für Zahn-, Mund und Kieferheilkunde der Uniklinik Gießen; Poliklinik für zahnärztliche Prothetik am Zentrum für Zahn-, Mund- und Kieferheilkunde der Uniklinik Gießen",info3mespe@mmm.com; Bernd.Wöstmann@dentist.med.uni-giessen.de; Bernd.Wöstmann@dentist.med.uni-giessen.de,"Arm 1 Temporary restoration made of Protemp 4; Arm 2 Temporary restoration made of Luxatemp® Automix Plus
Reference data, retrospective comparison",2009-08-26,NA,2009-08-28,25,Interventional,TRUE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,TRUE,2009,NA,FALSE,TRUE,FALSE
23542,NA,DRKS00009614,DRKS00009614,NCT: NA ICTRP: 2016-06-27 DRKS: 2016-06-27,1,1,NA,1,1,NA,NA,2,1,NA,3,1,Scale and aggregation missing. Details from description,4,0,Aggregation Method missing; Article: One day difference in follow-up length,NCT: NA ICTRP: 20 DRKS: Tatsächlich 20,20,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,ganzer Artikel,https://doi.org/10.1002/ejp.1089,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,270/13,Long and short term effects of Matrixstimulation in cancer pain.,Long and short term effects of Matrixstimulation in cancer pain. ,muecke@uni-bonn.de,muecke@uni-bonn.de,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Treatment;,N/A,2016-06-27,2014-01-03,20,Complete: follow-up complete,Universitätsklinikum Bonn,NULL,germany,"Intervention 1: Patient with cancer pain, Matrixstimulation, 4 Hz, 5 Minutes, Stimulation twice a day (morning and evening) on three consecutive days (day 1-3).","Inclusion criteria: Inclusion criteria was a minimum age of 18 years and a written consent after a detailed explanation of the investigation,
Cancer pain","Exclusion criteria: Exclusion criteria were contraindications to the use of electrical stimulation such as the presence of cardiac pacemakers or other implanted electronic devices, severe
cardiac arrhythmia, osteosyntheses, malignant tumors, neurological diseases, peripheral vascular diseases, pregnancy, breastfeeding women, haemophilia, skin or soft tissue disease or chronic pain syndromes such as migraine or back pain. Previous experience with electrical stimulation methods was also an exclusion criteria inorder to avoid an expectation bia",Leads the Matrixstimulation to a significant pain reduction compared to Baseline? Rating carried out in accordance of the Numeric Rating Scale (NRS),"Reduction of on demand medication during follow-up (day 4-7). On demand opioid drug use will be converted into an oral morphine equivalent (OME) for ease of comparison (Baseline, Therapy, Follow-up).",,2016-06-27,yes,"Cancer pain (pancreas, lung cancer ...); Chronic intractable pain","Arm 1 Patient with cancer pain, Matrixstimulation, 4 Hz, 5 Minutes, Stimulation twice a day (morning and evening) on three consecutive days (day 1-3).",Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,Leads the Matrixstimulation to a significant pain reduction compared to Baseline? Rating carried out in accordance of the Numeric Rating Scale (NRS),"Reduction of on demand medication during follow-up (day 4-7). On demand opioid drug use will be converted into an oral morphine equivalent (OME) for ease of comparison (Baseline, Therapy, Follow-up).",Germany,University Medical Center Bonn,2014-01-03,Actual,20,2015-05-31,"Inclusion criteria was a minimum age of 18 years and a written consent after a detailed explanation of the investigation,
Cancer pain","Exclusion criteria were contraindications to the use of electrical stimulation such as the presence of cardiac pacemakers or other implanted electronic devices, severe
cardiac arrhythmia, osteosyntheses, malignant tumors, neurological diseases, peripheral vascular diseases, pregnancy, breastfeeding women, haemophilia, skin or soft tissue disease or chronic pain syndromes such as migraine or back pain. Previous experience with electrical stimulation methods was also an exclusion criteria inorder to avoid an expectation bia",Long and short term effects of Matrixstimulation in cancer pain.,"Recruiting complete, follow-up complete",Universitätsklinikum Bonn; Klinik und Poliklinik für PalliativmedizinUniversitätsklinikum Bonn; Klinik und Poliklinik für PalliativmedizinUniversitätsklinikum Bonn,[---]*; muecke@uni-bonn.de; muecke@uni-bonn.de,"Arm 1 Patient with cancer pain, Matrixstimulation, 4 Hz, 5 Minutes, Stimulation twice a day (morning and evening) on three consecutive days (day 1-3).",2014-01-03,NA,2016-06-27,20,Interventional,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2014,NA,FALSE,TRUE,FALSE
23773,NA,DRKS00010233,DRKS00010233,NCT: NA ICTRP: 2016-04-11 DRKS: 2016-04-11,1,NA,NA,1,NA,NA,NA,NA,NA,NA,3,NA,No measure and no aggregation method,4,NA,no AM,NCT: NA ICTRP: 100 DRKS: Tatsächlich 100,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,451/15s,Multi-Centre Trial to Evaluate the Clinical Performance of the Lifetech/Medtronic Ceraflex-ASD-Occluder for Transcatheter Closure of Secundum Atrial Septal Defects,Multi-Centre Trial to Evaluate the Clinical Performance of the Lifetech/Medtronic Ceraflex-ASD-Occluder for Transcatheter Closure of Secundum Atrial Septal Defects - Ceraflex-ASD-Occluder ,ewert@dhm.mhn.de,eicken@dhm.mhn.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Other;,N/A,2016-04-11,2016-04-26,100,Complete: follow-up complete,Deutsches Herzzentrum München,NULL,germany,Intervention 1: Monitoring of patients with scheduled transcatheter closure of Secundum Atrial Septal Defects (ASD II) with Ceraflex-ASD-Occluder,"Inclusion criteria: Able to fluently speak and understand German language, existent ostium secundum atrial septal defect (ASD II), presence of a hemodynamically significant ASD II (right ventricular volume overload determined by transthoracic echo (TTE)), defect hole(s) to be covered by an available Ceraflex ASD device, sufficient margin to place the device, Informed Consent prior to treatment and willing to return for the post-treatment evaluation at the implanting institution after 6 month","Exclusion criteria: presence of multiple defects which cannot adequately covered by implantation of one device, current participation in another ongoing clinical device or drug trial, recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF), active bacterial and/or viral infection, evidence of intra-cardiac thrombi on echocardiography, any existent disorder that, in opinion of the investigator, might interfere with the conduct of the trial","Early performance success, defined as the rate of a successful placement of the device and successful closure of the defect without major complication until the day of discharge.","Late performance success defined as: successful closure of the defect without major complication (surgical reintervention, device embolization, moderate or large residual shunt, new AV block II or III° ) 6 month after the procedure",,2016-04-11,yes,Atrial septal defect,Arm 1 Monitoring of patients with scheduled transcatheter closure of Secundum Atrial Septal Defects (ASD II) with Ceraflex-ASD-Occluder,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Early performance success, defined as the rate of a successful placement of the device and successful closure of the defect without major complication until the day of discharge. ","Late performance success defined as: successful closure of the defect without major complication (surgical reintervention, device embolization, moderate or large residual shunt, new AV block II or III° ) 6 month after the procedure ",Germany,other München; Medical Center Leipzig; University Medical Center Freiburg-Bad Krozingen ,2016-04-26,Actual,100,2019-12-19,"Able to fluently speak and understand German language, existent ostium secundum atrial septal defect (ASD II), presence of a hemodynamically significant ASD II (right ventricular volume overload determined by transthoracic echo (TTE)), defect hole(s) to be covered by an available Ceraflex ASD device, sufficient margin to place the device, Informed Consent prior to treatment and willing to return for the post-treatment evaluation at the implanting institution after 6 month
","presence of multiple defects which cannot adequately covered by implantation of one device, current participation in another ongoing clinical device or drug trial, recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF), active bacterial and/or viral infection, evidence of intra-cardiac thrombi on echocardiography, any existent disorder that, in opinion of the investigator, might interfere with the conduct of the trial
",Multi-Centre Trial to Evaluate the Clinical Performance of the Lifetech/Medtronic Ceraflex-ASD-Occluder for Transcatheter Closure of Secundum Atrial Septal Defects,"Recruiting complete, follow-up complete","Deutsches Herzzentrum München; Deutsches Herzzentrum München Klinik für Kinderkardiologie und angeborene Herzfehler; Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler",[---]*; ewert@dhm.mhn.de; eicken@dhm.mhn.de,Arm 1 Monitoring of patients with scheduled transcatheter closure of Secundum Atrial Septal Defects (ASD II) with Ceraflex-ASD-Occluder,2016-04-26,NA,2016-04-11,100,Observational,FALSE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2016,NA,FALSE,TRUE,FALSE
22486,NA,DRKS00012396,DRKS00012396,NCT: NA ICTRP: 2017-06-09 DRKS: 2017-06-09,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure (calculation of ""Konkordanz"")",3,NA,"no AM, no measure",NCT: NA ICTRP: 250 DRKS: Tatsächlich 250,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,PV5477,„Limited Options with Extended Resistance to antiretroviral therapy: A National Survey of Triple Class Resistance”,„Limited Options with Extended Resistance to antiretroviral therapy: A National Survey of Triple Class Resistance” - LOWER ,hoffmann@ich-hamburg.de,hoffmann@ich-hamburg.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Diagnostic;,,2017-06-09,2017-04-03,250,Complete: follow-up complete,ICH Study Center,NULL,germany,Intervention 1: Single arm. Interventions: Questionnaires for patients and treating physicians. Collection of 10 mL EDTA blood (during routine checks) for resistance analysis,"Inclusion criteria: Documented HIV-infection, age of at least 18 years, documented triple-class-resistance (NRTIs, NNRTIs, PIs or INSTIs), documented by at least one resistance test), written informed consent","Exclusion criteria: No documented triple-class resistance, medical illness that does not allow safe blood draw, age under 18 years, cognitive impairment leading to inability to fill out the questionnaires and/or to give informed assent or consent.",Concordance between current resistance analysis (evaluated by ultra deep sequencing from proviral DNA) and prior resistance pattern (historical test results),"Current antiretroviral therapy, remaining options. Virological and immunological situation. Physical and mental health of the patients. Adherence and treatment satisfaction with current antiretroviral therapy (evaluated by questionnaires)",,2017-06-09,yes,Unspecified human immunodeficiency virus [HIV] disease,Arm 1 Single arm. Interventions: Questionnaires for patients and treating physicians. Collection of 10 mL EDTA blood (during routine checks) for resistance analysis,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),NA,Concordance between current resistance analysis (evaluated by ultra deep sequencing from proviral DNA) and prior resistance pattern (historical test results),"Current antiretroviral therapy, remaining options. Virological and immunological situation. Physical and mental health of the patients. Adherence and treatment satisfaction with current antiretroviral therapy (evaluated by questionnaires)",Germany,"Doctor's Practice Aachen, Berlin, Frankfurt, Hamburg, Hannover, Mannheim, München, Köln, Stuttgart; University Medical Center Kiel, Essen, Bonn",2017-04-03,Actual,250,2017-11-24,"Documented HIV-infection, age of at least 18 years, documented triple-class-resistance (NRTIs, NNRTIs, PIs or INSTIs), documented by at least one resistance test), written informed consent","No documented triple-class resistance, medical illness that does not allow safe blood draw, age under 18 years, cognitive impairment leading to inability to fill out the questionnaires and/or to give informed assent or consent. ",„Limited Options with Extended Resistance to antiretroviral therapy: A National Survey of Triple Class Resistance” ,"Recruiting complete, follow-up complete","ICH Study Center; Infektionsmedizinisches Centrum Hamburg, ICH Study Center; Infektionsmedizinisches Centrum Hamburg, ICH Study Center",hoffmann@ich-hamburg.de; hoffmann@ich-hamburg.de; hoffmann@ich-hamburg.de,Arm 1 Single arm. Interventions: Questionnaires for patients and treating physicians. Collection of 10 mL EDTA blood (during routine checks) for resistance analysis,2017-04-03,NA,2017-06-09,250,Observational,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2017,NA,FALSE,TRUE,FALSE
21934,NA,DRKS00012672,DRKS00012672,NCT: NA ICTRP: 2017-12-04 DRKS: 2017-12-04,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,"Assuming ""significant difference"" refers to difference in mean grades",NA,NA,NA,NCT: NA ICTRP: 139 DRKS: Tatsächlich 139,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-216-f-S,"Comparison of an e-learning-based grading system and a paper-based, dichotomous test sheet with the regard to the performance of students in the orthodontic curricular courses.","Comparison of an e-learning-based grading system and a paper-based, dichotomous test sheet with the regard to the performance of students in the orthodontic curricular courses. ",stammt@uni-muenster.de,m_bial02@uni-muenster.de,Interventional,Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Other. Assignment: Parallel. Study design purpose: Other;,N/A,2017-12-04,2017-04-28,139,Complete: follow-up continuing,"Poliklinik für Kieferorthopädie, Universitätsklinikum Münster",NULL,germany,Intervention 1: Test group: participants get grades in the courses of orthodontics- via the e-larning based portal Itunes U Intervention 2: Control group: participants receive the dichotomous test sheet and additionally grades in secret,Inclusion criteria: Students attending one of the orthodontic courses of the WWU in the summer semester 2017,Exclusion criteria: Students who did not pass one of those courses in the first attempt and therefore repeat it.,Do the participants of the test group achieve better results (which means grades) than the control group or are there no differences?,NULL,,2017-12-04,yes,performance of students,Arm 1 Test group: participants get grades in the courses of orthodontics- via the e-larning based portal Itunes U; Arm 2 Control group: participants receive the dichotomous test sheet and additionally grades in secret,Interventional,Randomized controlled trial,Open (masking not used),Other,Parallel,N/A,Do the participants of the test group achieve better results (which means grades) than the control group or are there no differences?,NA,Germany,University Medical Center Münster,2017-04-28,Actual,139,NA,Students attending one of the orthodontic courses of the WWU in the summer semester 2017,Students who did not pass one of those courses in the first attempt and therefore repeat it.,"Comparison of an e-learning-based grading system and a paper-based, dichotomous test sheet with the regard to the performance of students in the orthodontic curricular courses. ","Recruiting complete, follow-up continuing","Poliklinik für Kieferorthopädie, Universitätsklinikum Münster; Poliklinik für Kieferorthopädie, Universitätsklinikum Münster; Poliklinik für Kieferorthopädie, Universitätsklinikum Münster",stammt@uni-muenster.de; stammt@uni-muenster.de; m_bial02@uni-muenster.de,Arm 1 Test group: participants get grades in the courses of orthodontics- via the e-larning based portal Itunes U; Arm 2 Control group: participants receive the dichotomous test sheet and additionally grades in secret,2017-04-28,NA,2017-12-04,139,Interventional,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2017,NA,FALSE,TRUE,FALSE
20882,NA,DRKS00015507,DRKS00015507,NCT: NA ICTRP: 2018-10-09 DRKS: 2018-10-09,1,1,NA,1,1,a,Criteria more specific in paper,NA,NA,NA,4,1,no AM,NA,NA,NA,NCT: NA ICTRP: 22000 DRKS: Tatsächlich 22000,24273,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/j.amsu.2020.06.034,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,FF 117/2016,Graduated compression stockings – Are they effective in reducing postoperative symptomatic and fatal pulmonary embolism?A propensity matched analysis in 24273 patients,"Graduated compression stockings – Are they effective in reducing postoperative symptomatic and fatal pulmonary embolism?A propensity matched analysis in 24273 patients - MTPS-Trial, GCS-Trial ",e.hanisch@asklepios.com,e.hanisch@asklepios.com,Observational,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Control group receives no treatment. Assignment: Other. Study design purpose: Prevention;,N/A,2018-10-09,2006-01-01,22000,Complete: follow-up complete,Asklepios Klinik Langen,NULL,germany,Intervention 1: use of gcs (graduated compression stockings) Intervention 2: no use of gcs,Inclusion criteria: Intervention or surgery during hospitalisation,Exclusion criteria: Age under 18; no intervention or no surgery during hospitalisation,Pulmonary embolism post operative during hospitalisation; diagnosis through clinic or ct-scan,NULL,,2018-10-09,yes,Pulmonary embolism,Arm 1 use of gcs (graduated compression stockings); Arm 2 no use of gcs,Non-interventional,Non-randomized controlled trial,Open (masking not used),Control group receives no treatment,Other,N/A,Pulmonary embolism post operative during hospitalisation; diagnosis through clinic or ct-scan,NA,Germany,Medical Center Langen,2006-01-01,Actual,22000,2016-03-31,Intervention or surgery during hospitalisation,Age under 18; no intervention or no surgery during hospitalisation,Graduated compression stockings – Are they effective in reducing postoperative symptomatic and fatal pulmonary embolism?
A propensity matched analysis in 24273 patients,"Recruiting complete, follow-up complete",Asklepios Klinik Langen; Asklepios Klinik Langen; Asklepios Klinik Langen,e.hanisch@asklepios.com; e.hanisch@asklepios.com; e.hanisch@asklepios.com,Arm 1 use of gcs (graduated compression stockings); Arm 2 no use of gcs,2006-01-01,NA,2018-10-09,22000,Observational,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2006,NA,FALSE,TRUE,FALSE
20746,NA,DRKS00009250,DRKS00009250,NCT: NA ICTRP: 2018-11-13 DRKS: 2018-11-13,1,NA,NA,1,NA,NA,"The given criteria on gender and age obviously don't apply (but were mandatory, it seems) here, because the trial refers to hospitals. Unclear if there were any criteria for selecting hospitals.",1,NA,NA,4,NA,no time frame,NA,NA,NA,NCT: NA ICTRP: 30 DRKS: Tatsächlich 30,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No intervention in title,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,4536-08/15,Quality Improvement in Infection Control and Sepsis Management in Model Regions,Quality Improvement in Infection Control and Sepsis Management in Model Regions - ICOSMOS ,hendrik.rueddel@med.uni-jena.de,hendrik.rueddel@med.uni-jena.de,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Health care system;,N/A,2018-11-13,2015-10-01,30,Complete: follow-up complete,Bundesministerium für Bildung und Forschung Dienstsitz Berlin,NULL,germany,"Intervention 1: Risk-adjusted analysis of standardized data from hospital reimbursement claims (§21-Datatset according to the German Law of Hospital Reimbursement (Krankenhausentgeltgesetz)) of patients with sepsis, severe sepsis and septic shock of participating hospitals. The quality reports for analyses are created every three months for all participating hospitals allowing individual case analyses, analyses according to departments, and anonymous benchmarking with all other participating hospitals and the German average.","Inclusion criteria: Hospitals with intensive care unit (participants of the trial are hospitals, not patients!)",Exclusion criteria: Hospitals without intensive care units,"standardized mortality ratio (i.e. ratio of actual to expected mortality) of patients with sepsis, severe sepsis and septic shock for each participating hospital, analysed every 3 months by §21-dataset",same as primary end point but in relation to German average,,2018-11-13,yes,Septic shock; Systemic Inflammatory Response Syndrome of infectious origin with organ failure,"Arm 1 Risk-adjusted analysis of standardized data from hospital reimbursement claims (§21-Datatset according to the German Law of Hospital Reimbursement (Krankenhausentgeltgesetz)) of patients with sepsis, severe sepsis and septic shock of participating hospitals. The quality reports for analyses are created every three months for all participating hospitals allowing individual case analyses, analyses according to departments, and anonymous benchmarking with all other participating hospitals and the German average.",Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"standardized mortality ratio (i.e. ratio of actual to expected mortality) of patients with sepsis, severe sepsis and septic shock for each participating hospital, analysed every 3 months by §21-dataset",same as primary end point but in relation to German average,Germany,,2015-10-01,Actual,30,2018-06-30,"Hospitals with intensive care unit (participants of the trial are hospitals, not patients!)",Hospitals without intensive care units,Quality Improvement in Infection Control and Sepsis Management in Model Regions,"Recruiting complete, follow-up complete",Bundesministerium für Bildung und Forschung Dienstsitz Berlin; Klinik für Anästhesiologie und IntensivtherapieUniversitätsklinikum Jena; Klinik für Anästhesiologie und IntensivtherapieUniversitätsklinikum Jena,[---]*; hendrik.rueddel@med.uni-jena.de; hendrik.rueddel@med.uni-jena.de,"Arm 1 Risk-adjusted analysis of standardized data from hospital reimbursement claims (§21-Datatset according to the German Law of Hospital Reimbursement (Krankenhausentgeltgesetz)) of patients with sepsis, severe sepsis and septic shock of participating hospitals. The quality reports for analyses are created every three months for all participating hospitals allowing individual case analyses, analyses according to departments, and anonymous benchmarking with all other participating hospitals and the German average.",2015-10-01,NA,2018-11-13,30,Interventional,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,2015,NA,FALSE,TRUE,FALSE
26201,NA,DRKS00005443,DRKS00005443,NCT: NA ICTRP: 2013-11-12 DRKS: 2013-11-12,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,5,NA,NA,NCT: NA ICTRP: 110 DRKS: Tatsächlich 110,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-001006-24;EUCTR2012-001006-24-DE;2013-06-19,Ranibizumab and Vitrectomy in the Therapy of Diabetic Macular Edema,Ranibizumab and Vitrectomy in the Therapy of Diabetic Macular Edema - RAVIT-DME ,a.schueler@retina.to,k.graumann@pharmakologie-bremen.de,Interventional,Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Treatment;,IV,2013-11-12,2014-04-07,110,Other,Augenklinik Universitätsallee,NULL,germany,"Intervention 1: initial vitrectomy with ILM-peeling with intraoperative andministration of Ranibizumab 0,5 mg intravitreally. After vitrectomy, 2 further injections of 0,5 mg Ranibizumab every 4 weeks will be performed, according to the label of Ranibizumab (Lucentis ®). After the first 3 obligatory treatments with Ranibizumab, examination will be performed every 4 weeks. Further injections will be given, according to the label of Ranibizumab (Lucentis ®), if indicated. Intervention 2: Three initial injections of 0,5 mg Ranibizumab every 4 weeks will be performed, according to the label of Ranibizumab (Lucentis ®). After the first 3 obligatory treatments with Ranibizumab, examination will be performed every 4 weeks. Further injections will be given, according to the label of Ranibizumab (Lucentis ®), if indicated","Inclusion criteria: Patients aged 18 years and older
- - - Diabetes mellitus type 2 (insulin-dependent diabetes mellitus (IDDM) and noninsulin-dependent diabetes mellitus (NIDDM))
- - - Clinical significant diabetic macular edema (diffuse or focal)
- - - Visual acuity (decimal) reduced by diabetic macular edema to = 0,3 and = 0,05 (LogMar = 1,3 and = 0,5) stated by EDTRS charts.
- - - Signed informed consent","Exclusion criteria: The investigator is clinically not convinced about vitrectomy being indicated or the possible side effects outweigh the possible positive effects of vitrectomy
- - - Diabetes mellitus type 1
- - - Visual acuity of the study eye (decimal) > 0,3 (LogMar 1,3)
- - - Central retinal thickness stated by SD-OCT 10 % or if it can be expected that the patient’s diabetes cannot be controlled adequately during the trial
- - - Uncontrolled arterial Hypertension defined as a systolic value of > 180 mmHg and/or a diastolic value of > 110 mmHg
- - - Systemic therapy with steroids or anticoagulative therapy with coumarin derivatives or heparin (Aspirin or Clopidogrel is allowed)
- - - History of allergy to fluorescein or ranibizumab
- - - Women who are pregnant or planning a pregnancy
- - - Women who are breast feeding
- - - Inability to comply with study or follow-up procedures",Number of injections of study drug during the first year of treatment
Mean change from baseline in BCVA at month 12 (visit 13)
Visual acuity measured by ETDRS-charts,Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 (visit 13) compared with baseline
- - - Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline (visual acuity measured by ETDRS-charts)
- - - Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 (at month 2)
- - - Drop out rates
- - - Rate of non-responders
- - - Retinal lesions
- - - Changes in retinal thickness from baseline at month 4 and 12 (visit 13) via Optical Coherence Tomography (OCT)
- - - AEs
- - - Quality of Life at visit 1 (before treatment) and visit 13 (month 12); questionnaire VFQ25.,2012-001006-24; EUCTR2012-001006-24-DE,2013-11-12,yes,[generalization E14.3: Unspecified diabetes mellitus; With ophthalmic complications]; Other specified retinal disorders,"Arm 1 initial vitrectomy with ILM-peeling with intraoperative andministration of Ranibizumab 0,5 mg intravitreally. After vitrectomy, 2 further injections of 0,5 mg Ranibizumab every 4 weeks will be performed, according to the label of Ranibizumab (Lucentis ®). After the first 3 obligatory treatments with Ranibizumab, examination will be performed every 4 weeks. Further injections will be given, according to the label of Ranibizumab (Lucentis ®), if indicated.; Arm 2 Three initial injections of 0,5 mg Ranibizumab every 4 weeks will be performed, according to the label of Ranibizumab (Lucentis ®). After the first 3 obligatory treatments with Ranibizumab, examination will be performed every 4 weeks. Further injections will be given, according to the label of Ranibizumab (Lucentis ®), if indicated",Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,IV,Number of injections of study drug during the first year of treatment
Mean change from baseline in BCVA at month 12 (visit 13)
Visual acuity measured by ETDRS-charts,Proportion of patients with a vision acuity loss of fewer than 15 letters at month 12 (visit 13) compared with baseline
- - - Proportion of patients with a vision acuity loss of more than 15 letters at month 12 (visit 13) compared with baseline (visual acuity measured by ETDRS-charts)
- - - Proportion of patients with a treatment-free interval of at least 3 months duration at any time point following visit 3 (at month 2)
- - - Drop out rates
- - - Rate of non-responders
- - - Retinal lesions
- - - Changes in retinal thickness from baseline at month 4 and 12 (visit 13) via Optical Coherence Tomography (OCT)
- - - AEs
- - - Quality of Life at visit 1 (before treatment) and visit 13 (month 12); questionnaire VFQ25.
,Germany,Medical Center Bremen; Medical Center Berlin; Medical Center Dessau; Medical Center Münster; Medical Center Gelsenkirchen; University Medical Center Göttingen; Medical Center Bremen; Medical Center Berlin ,2014-04-07,Actual,110,2016-08-01,"Patients aged 18 years and older
- - - Diabetes mellitus type 2 (insulin-dependent diabetes mellitus (IDDM) and noninsulin-dependent diabetes mellitus (NIDDM))
- - - Clinical significant diabetic macular edema (diffuse or focal)
- - - Visual acuity (decimal) reduced by diabetic macular edema to ≤ 0,3 and ≥ 0,05 (LogMar ≤ 1,3 and ≥ 0,5) stated by EDTRS charts.
- - - Signed informed consent
","The investigator is clinically not convinced about vitrectomy being indicated or the possible side effects outweigh the possible positive effects of vitrectomy
- - - Diabetes mellitus type 1
- - - Visual acuity of the study eye (decimal) > 0,3 (LogMar < 0,5)
- - - Visual acuity of the study eye (decimal) < 0,05 (LogMar > 1,3)
- - - Central retinal thickness stated by SD-OCT < 250 µm
- - - Any clouding of optical media influencing the evaluation of the retina
- - - Previous focal laser coagulation of the macula in the study eye within 3 months prior to baseline
- - - Previous treatment of diabetic macular edema involving intravitreal steroids or VEGF blockers within 3 months prior to baseline
- - - Previous vitrectomy in the study eye
- - - Previous cataract surgery in the study eye within 3 months prior to baseline
- - - Pseudophakia with opening of the posterior capsule by surgery or YAG laser capsulotomy within 3 months prior to baseline
- - - History of glaucoma (including or excluding local or systemic therapy) in either eye
- - - Uveitis or extraocular inflammation in either eye
- - - Pseudoexfoliative syndrome
- - - Known ocular ischemia syndrome in either eye (occlusion of extraocular arteries, influencing the vascularisation of the study eye)
- - - Retinal venous occlusion in the study eye
- - - History of retinal detachment (including or excluding any therapy) in either eye
- - - Tractive retinal detachment due to diabetic epiretinal proliferation in the study eye
- - - Intravitreal hemorrhage interfering with the assessment of the posterior pole in the study eye prior to baseline
- - - Active malignancies (history of successful treated malignancies is not an exclusion criterion)
- - - History of cerebral vascular accident or myocardial infarction within 12 months prior to baseline
- - - Diabetes mellitus with HbA1c > 10 % or if it can be expected that the patient’s diabetes cannot be controlled adequately during the trial
- - - Uncontrolled arterial Hypertension defined as a systolic value of > 180 mmHg and/or a diastolic value of > 110 mmHg
- - - Systemic therapy with steroids or anticoagulative therapy with coumarin derivatives or heparin (Aspirin or Clopidogrel is allowed)
- - - History of allergy to fluorescein or ranibizumab
- - - Women who are pregnant or planning a pregnancy
- - - Women who are breast feeding
- - - Inability to comply with study or follow-up procedures
",Ranibizumab and Vitrectomy in the Therapy of Diabetic Macular Edema,Recruiting stopped after recruiting started ,Augenklinik Universitätsallee; Augenklinik Universitätsallee; Institut für Pharmakologie,a.schueler@retina.to; a.schueler@retina.to; k.graumann@pharmakologie-bremen.de,"Arm 1 initial vitrectomy with ILM-peeling with intraoperative andministration of Ranibizumab 0,5 mg intravitreally. After vitrectomy, 2 further injections of 0,5 mg Ranibizumab every 4 weeks will be performed, according to the label of Ranibizumab (Lucentis ®). After the first 3 obligatory treatments with Ranibizumab, examination will be performed every 4 weeks. Further injections will be given, according to the label of Ranibizumab (Lucentis ®), if indicated.; Arm 2 Three initial injections of 0,5 mg Ranibizumab every 4 weeks will be performed, according to the label of Ranibizumab (Lucentis ®). After the first 3 obligatory treatments with Ranibizumab, examination will be performed every 4 weeks. Further injections will be given, according to the label of Ranibizumab (Lucentis ®), if indicated",2014-04-07,NA,2013-11-12,110,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,2014,NA,FALSE,TRUE,TRUE
21221,NA,DRKS00013924,DRKS00013924,NCT: NA ICTRP: 2018-06-29 DRKS: 2018-06-29,1,NA,NA,2,NA,NA,NA,1,NA,"""stimulierte Spontanmeldungen von Unerwünschten Arzneitmittelwirkungen"" meaning ""simuliert""?",3,NA,"No time frame, no definition of ""arzneimittelbedingt""",1,NA,"no AM, no metric, no time frame, no measure",NCT: NA ICTRP: 52500 DRKS: Tatsächlich 47400,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,01NVF16021;351_17 B,KiDSafe - Improving medication safety for children and adolescents: implementation and evaluation of a new form of care,KiDSafe - Improving medication safety for children and adolescents: implementation and evaluation of a new form of care - KiDSafe ,antje.neubert@uk-erlangen.de,ki-kidsafe@uk-erlangen.de,Interventional,Allocation: Randomized controlled trial;. Masking: Blinded (assessor). Control: Other. Assignment: Other. Study design purpose: Other;,N/A,2018-06-29,2018-07-01,47400,Recruiting,"Konsortialführung: Universitätsklinikum Erlangen, Kinder- und Jugendklinik",NULL,germany,"Intervention 1: Intervention phase: Use of a digital paediatric drug information system,
participation to regular paediatric-pharmacological quality circles,
stimulated spontaneous reporting of adverse drug reactions and medication errors in outpatient paediatricians, psychiatrists and general practitioners Intervention 2: Control phase","Inclusion criteria: non-elective admitted patients, who are less than 18 years of age at the time of admission",Exclusion criteria: oncological patients who are hospitalized with suspected ADR/ME and who have been hospitalized in the previous 4 weeks for oncological
treatment,Incidence of drug-related hospital admissions,Prescribing and reporting behavior of outpatient doctors,01NVF16021,2018-06-29,yes,Quality assurance procedure to increase the safety of drug therapy for children and adolescents,"Arm 1 Intervention phase: Use of a digital paediatric drug information system,
participation to regular paediatric-pharmacological quality circles,
stimulated spontaneous reporting of adverse drug reactions and medication errors in outpatient paediatricians, psychiatrists and general practitioners
; Arm 2 Control phase ",Interventional,Randomized controlled trial,Blinded,Other,Other,N/A,Incidence of drug-related hospital admissions,Prescribing and reporting behavior of outpatient doctors
,Germany,University Medical Center Erlangen; University Medical Center Aachen; University Medical Center Mainz; University Medical Center Leipzig; University Medical Center Minden; Medical Center Sankt Augustin; University Medical Center Wuppertal; Medical Center Coburg; Medical Center Landshut; Medical Center Chemnitz; Medical Center Krefeld; University Medical Center Rostock,2018-07-01,Actual,47400,NA,"non-elective admitted patients, who are less than 18 years of age at the time of admission",oncological patients who are hospitalized with suspected ADR/ME and who have been hospitalized in the previous 4 weeks for oncological
treatment,KiDSafe - Improving medication safety for children and adolescents: implementation and evaluation of a new form of care,Recruiting ongoing,"Konsortialführung: Universitätsklinikum Erlangen, Kinder- und Jugendklinik; Universitätsklinikum Erlangen, Kinder- und Jugendklinik; Universitätsklinikum Erlangen, Kinder- und Jugendklinik",ki-kidsafe@uk-erlangen.de; antje.neubert@uk-erlangen.de; ki-kidsafe@uk-erlangen.de,"Arm 1 Intervention phase: Use of a digital paediatric drug information system,
participation to regular paediatric-pharmacological quality circles,
stimulated spontaneous reporting of adverse drug reactions and medication errors in outpatient paediatricians, psychiatrists and general practitioners
; Arm 2 Control phase ",2018-07-01,NA,2018-06-29,47400,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,2018,NA,FALSE,TRUE,FALSE
25385,NA,DRKS00006976,DRKS00006976,NCT: NA ICTRP: 2014-10-28 DRKS: 2014-10-28,1,NA,NA,2,NA,NA,NA,NA,NA,NA,2,NA,"No AM, no time frame, no metric",NA,NA,NA,NCT: NA ICTRP: 60 DRKS: Tatsächlich 60,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,014/1203,Data collection RELIEF -Data collection with a herbal combination product as a dietary-supportive measure for alcohol detoxification,Data collection RELIEF -Data collection with a herbal combination product as a dietary-supportive measure for alcohol detoxification - RELIEF ,schmidt@eusano.com,goekcen.alco@dr-schauerte.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Other;,N/A,2014-10-28,2015-01-08,60,Complete: follow-up complete,Eusano GmbH & Co. KG,NULL,germany,Intervention 1: Intake of Eusano formulation 3 capsules per day,"Inclusion criteria: • Male and female patients over 18 years (no upper age limit), who are participating in an alcohol detoxification therapy and taking the dietary-supportive supplement (Eusano formulation)
• Pure alcohol dependence
• No known contraindications
• Written informed consent of the patient to the prospective collection, distribution, analysis of the data and for publication of the results.",Exclusion criteria: • Patients under 18 years
• Polytoxicomania
• Allergies to the various herbal ingredients of EUSANO formulation (food intolerance)
• Pregnancy,"Knowledge about changes in well-being during an alcohol detoxification therapy by taking dietary-supportive supplement (Eusano formulation).
The results will be obtained by using a questionnaire (Bf-SR '), which will be filled out by the patient only 5 times during the detoxification therapy.",Not applicable,,2014-10-28,no,Mental and behavioural disorders due to use of alcohol; Dependence syndrome,Arm 1 Intake of Eusano formulation 3 capsules per day,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Knowledge about changes in well-being during an alcohol detoxification therapy by taking dietary-supportive supplement (Eusano formulation).
The results will be obtained by using a questionnaire (Bf-SR '), which will be filled out by the patient only 5 times during the detoxification therapy.
",Not applicable,Germany,Medical Center Haar,2015-01-08,Actual,60,2015-07-23,"• Male and female patients over 18 years (no upper age limit), who are participating in an alcohol detoxification therapy and taking the dietary-supportive supplement (Eusano formulation)
• Pure alcohol dependence
• No known contraindications
• Written informed consent of the patient to the prospective collection, distribution, analysis of the data and for publication of the results. ",• Patients under 18 years
• Polytoxicomania
• Allergies to the various herbal ingredients of EUSANO formulation (food intolerance)
• Pregnancy,Data collection RELIEF -
Data collection with a herbal combination product as a dietary-supportive measure for alcohol detoxification,"Recruiting complete, follow-up complete",Eusano GmbH & Co. KG; Eusano GmbH & Co. KG; Institut Dr. Schauerte,schmidt@eusano.com; schmidt@eusano.com; goekcen.alco@dr-schauerte.de,Arm 1 Intake of Eusano formulation 3 capsules per day,2015-01-08,NA,2014-10-28,60,Observational,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2015,NA,FALSE,TRUE,FALSE
21247,NA,DRKS00013559,DRKS00013559,NCT: NA ICTRP: 2018-06-21 DRKS: 2018-06-21,1,NA,NA,1,NA,NA,Diagnoses according to which criteria?,NA,NA,NA,4,NA,no measure (definition of sleep duration or time of day),3,NA,"no time frame, no metric",NCT: NA ICTRP: 328 DRKS: Geplant 328,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,17-7889-BO,"Acute CoROnary Syndrome, Stroke and Sleep","Acute CoROnary Syndrome, Stroke and Sleep - ACROSSS ",andreas.stang@uk-essen.de,acrosss@uk-essen.de,Observational,Allocation: Other;. Masking: Open (masking not used). Control: Other. Assignment: Other. Study design purpose: Basic research/physiological study;,N/A,2018-06-21,2018-07-01,328,Pending,"Zentrum für Klinische EpidemiologieInstitut für Medizinische Informatik, Epidemiologie und Biometrie",NULL,germany,"Intervention 1: The ACROSSS Study includes patients who have sufferred from a myocardial infarction, a stroke or a transient ischemic attack. The aim of the study is to answer two questions: First, to investigate whether the acute event has an impact on the patients´ sleep like worse sleep quality or taking a nap more often. Second, to investigate which factors might have triggered the acute event, e.g. a nap taken shortly before or the intake of certain drugs.
The following investigations will be carried out:
T1: First contact with the participants who have left the intensive care unit
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks before the index event
- case-crossover questionnaire
- questionnaire on comorbidities and confounders
- questionnaire on functional restrictions
- sleep apnea measurement (using the device Apnea Link)
T2: 3 months after the index event
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks
- questionnaire on functional restrictions
- drug history
- measurement of sleep behaviour and daytime activity (using the device SOMNOwatch)
- assessment of vital status via questionnaire (further myocardial infarction / stroke / TIA / death)
T3: 1 year after the index event
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks
- questionnaire on functional restrictions
- drug history
- measurement of sleep behaviour and daytime activity (using the device SOMNOwatch)
- assessment of vital status via questionnaire (further myocardial infarction / stroke / TIA / death)
T4: about 5 years after the index event
- assessment of vital status including research on cause of death","Inclusion criteria: Inclusion criteria for patients with myocardial infarction:
first event (STEMI or NSTEMI), percutanous coronary intervention; no valvular defect
Inclusion criteria for patients with stroke:
first stroke ever;
all transient ischemic attacks (not only first events)","Exclusion criteria: no ability of giving consent;
aphasia, dementia, confusion of the patient;
for incidence study only: place of residences out of Essen and surrounding area",incident daytime napping; incident sleep disturbances; trigger of acute myocardial infarction / of stroke,Mortality,,2018-06-21,yes,Acute myocardial infarction; Cerebral infarction,"Arm 1 The ACROSSS Study includes patients who have sufferred from a myocardial infarction, a stroke or a transient ischemic attack. The aim of the study is to answer two questions: First, to investigate whether the acute event has an impact on the patients´ sleep like worse sleep quality or taking a nap more often. Second, to investigate which factors might have triggered the acute event, e.g. a nap taken shortly before or the intake of certain drugs.
The following investigations will be carried out:
T1: First contact with the participants who have left the intensive care unit
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks before the index event
- case-crossover questionnaire
- questionnaire on comorbidities and confounders
- questionnaire on functional restrictions
- sleep apnea measurement (using the device Apnea Link)
T2: 3 months after the index event
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks
- questionnaire on functional restrictions
- drug history
- measurement of sleep behaviour and daytime activity (using the device SOMNOwatch)
- assessment of vital status via questionnaire (further myocardial infarction / stroke / TIA / death)
T3: 1 year after the index event
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks
- questionnaire on functional restrictions
- drug history
- measurement of sleep behaviour and daytime activity (using the device SOMNOwatch)
- assessment of vital status via questionnaire (further myocardial infarction / stroke / TIA / death)
T4: about 5 years after the index event
- assessment of vital status including research on cause of death",Non-interventional,Other,Open (masking not used),Other,Other,N/A,incident daytime napping; incident sleep disturbances; trigger of acute myocardial infarction / of stroke,Mortality,Germany,University Medical Center Essen; Medical Center Elisabethkrankenhaus Essen,2018-07-01,Planned,328,NA,"Inclusion criteria for patients with myocardial infarction:
first event (STEMI or NSTEMI), percutanous coronary intervention; no valvular defect
Inclusion criteria for patients with stroke:
first stroke ever;
all transient ischemic attacks (not only first events)","no ability of giving consent;
aphasia, dementia, confusion of the patient;
for incidence study only: place of residences out of Essen and surrounding area","Acute CoROnary Syndrome, Stroke and Sleep",Recruiting planned,"Zentrum für Klinische EpidemiologieInstitut für Medizinische Informatik, Epidemiologie und Biometrie; Zentrum für Klinische Epidemiologie c/o Institut für Medizinische Informatik, Epidemiologie und Biometrie; Institut für Medizinische Informatik, Biometrie und Epidemiologie",andreas.stang@uk-essen.de; andreas.stang@uk-essen.de; acrosss@uk-essen.de,"Arm 1 The ACROSSS Study includes patients who have sufferred from a myocardial infarction, a stroke or a transient ischemic attack. The aim of the study is to answer two questions: First, to investigate whether the acute event has an impact on the patients´ sleep like worse sleep quality or taking a nap more often. Second, to investigate which factors might have triggered the acute event, e.g. a nap taken shortly before or the intake of certain drugs.
The following investigations will be carried out:
T1: First contact with the participants who have left the intensive care unit
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks before the index event
- case-crossover questionnaire
- questionnaire on comorbidities and confounders
- questionnaire on functional restrictions
- sleep apnea measurement (using the device Apnea Link)
T2: 3 months after the index event
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks
- questionnaire on functional restrictions
- drug history
- measurement of sleep behaviour and daytime activity (using the device SOMNOwatch)
- assessment of vital status via questionnaire (further myocardial infarction / stroke / TIA / death)
T3: 1 year after the index event
- questionnaires on sleep characteristics and sleep behaviour in the last 4 weeks
- questionnaire on functional restrictions
- drug history
- measurement of sleep behaviour and daytime activity (using the device SOMNOwatch)
- assessment of vital status via questionnaire (further myocardial infarction / stroke / TIA / death)
T4: about 5 years after the index event
- assessment of vital status including research on cause of death",2018-07-01,NA,2018-06-21,328,Observational,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2018,NA,FALSE,TRUE,FALSE
22686,NA,DRKS00011432,DRKS00011432,NCT: NA ICTRP: 2017-03-31 DRKS: 2017-03-31,1,NA,NA,2,NA,NA,NA,1,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 840 DRKS: [---]* 840,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-08-02,NA,2016-09-16,2022-01-27,Interventional,Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426),"A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)","Active, not recruiting",Phase 3,861,Actual,Merck Sharp & Dohme Corp.,Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Overall Survival (OS),Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Number of Participants Who Experienced an Adverse Event (AE);Number of Participants Who Discontinued Study Drug Due to an AE;Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants;Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants;Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants;Overall Survival (OS) Rate at Month 12 in All Participants;Overall Survival (OS) Rate at Month 18 in All Participants;Overall Survival (OS) Rate at Month 24 in All Participants;Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score;Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score,2016-000588-17;163460;MK-3475-426;KEYNOTE-426;3475-426,Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy in Participants With Renal Cell Carcinoma (MK-3475-426/KEYNOTE-426),"A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2016-07-29,2016-09-16,861,"Active, not recruiting",Merck Sharp & Dohme Corp.,NULL,"brazil;canada;czech republic;czechia;france;germany;hungary;ireland;japan;korea, republic of;poland;russian federation;spain;taiwan;ukraine;united kingdom;united states",Biological: Pembrolizumab;Drug: Axitinib;Drug: Sunitinib,"
Inclusion Criteria:
- Has histologically confirmed diagnosis of RCC with clear cell component with or
without sarcomatoid features.
- Has locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per
American Joint Committee on Cancer) or has recurrent disease.
- Has measurable disease per RECIST 1.1 as assessed by the investigator/site
radiologist.
- Has received no prior systemic therapy for advanced RCC.
- Has provided archival tumor tissue sample or newly obtained core or excisional biopsy
of a tumor lesion not previously irradiated.
- Has Karnofsky performance status (KPS) = 70% as assessed within 10 days prior to
randomization.
- If receiving bone resorptive therapy (including but not limited to bisphosphonate or
RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.
- Demonstrates adequate organ function.
- Female participants of childbearing potential must be willing to use an adequate
method of contraception for the course of the study through 120 days after the last
dose of study drug.
- Male participants of childbearing potential must agree to use an adequate method of
contraception, starting with the first dose of study drug through 120 days after the
last dose of study drug.
Exclusion Criteria:
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to randomization.
- Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior
to randomization, or has not recovered (i.e., = Grade 1 or at baseline) from AEs due
to prior treatment.
- Has had prior treatment with any anti-programmed cell death (anti-PD-1), or programmed
cell death ligand 1 (PD-L1), or PD-L2 agent or an antibody targeting any other
immune-regulatory receptors or mechanisms.
- Has received prior systemic anti-cancer therapy for RCC with vascular endothelial
growth factor (VEGF)/VEGF receptors (VEGFR) or mechanistic target of rapamycin (mTOR)
targeting agents.
- Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema,
hypotension, bronchospasm, angioedema or anaphylaxis) to axitinib or sunitinib.
- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy
exceeding physiologic corticosteroid dose or any other form of immunosuppressive
therapy within 7 days prior to randomization, except in the case of central nervous
system (CNS) metastases.
- Has an active autoimmune disease requiring systemic treatment with in the past 2 years
OR a documented history of clinically severe autoimmune disease. Note: Participants
with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy,
hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone
replacement, are not excluded.
- Has a known additional malignancy that has progressed or has required active treatment
in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma
of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in
situ are acceptable if they have undergone potentially curative therapy.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B or Hepatitis C infection.
- Has received a live virus vaccine within 30 days of randomization.
- Has a clinically significant gastrointestinal (GI) abnormality including:
- Malabsorption, total gastric resection
- Or any condition that might affect the absorption of orally taken medication
- Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3
months without evidence of resolution documented by endoscopy or colonoscopy
- Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease,
ulcerative colitis or other GI condition associated with increased risk of perforation
- Has QT interval corrected for heart rate (QTc) =480 msec.
- Has a history of any of the following cardiovascular conditions within 12 months of
randomization:
- Myocardial infarction
- Unstable angina pectoris
- Cardiac angioplasty or stenting
- Coronary/peripheral artery bypass graft
- Class III or IV congestive heart failure per New York Heart Association
- Cerebrovascular accident or transient ischemic attack
- Has a history of deep vein thrombosis or pulmonary embolism within 6 months of
screening.
- Has poorly controlled hypertension defined as systolic blood pressure (SBP) =150 mm Hg
and/or diastolic blood pressure (DBP) =90 mm Hg.
- Has evidence of inadequate wound healing.
- Has active bleeding disorder or other history of significant bleeding episodes within
30 days of randomization.
- Has hemoptysis within 6 weeks prior to randomization.
- Has current use (within 7 days of randomization) or anticipated need for treatment
with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors.
- Has current use (within 7 days of randomization) or anticipated need for treatment
with drugs that are known strong CYP3A4/5 inducers, including but not limited to
carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or
drugs that are known with proarrhythmic potential.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.
- Has had a prior solid organ transplant.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study drug.
",NULL,Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Overall Survival (OS),Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review;Number of Participants Who Experienced an Adverse Event (AE);Number of Participants Who Discontinued Study Drug Due to an AE;Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants;Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants;Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants;Overall Survival (OS) Rate at Month 12 in All Participants;Overall Survival (OS) Rate at Month 18 in All Participants;Overall Survival (OS) Rate at Month 24 in All Participants;Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score;Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score,2016-000588-17; NCT02853331; 3475-426; 2016-000588-17,2017-03-31,no,"Renal Cell Carcinoma; Malignant neoplasm of kidney, except renal pelvis",Arm 1 Biological: Pembrolizumab; Arm 2 Drug: Axitinib; Arm 3 Drug: Sunitinib,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,III,- Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review; time frame: Up to approximately 2 years
- Overall Survival (OS); time frame: Up to approximately 39 months
,- Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Independent Central Imaging Review; time frame: Up to approximately 2 years
- Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by Blinded Independent Central Imaging Review; time frame: Up to approximately 2 years
- Number of Participants Who Experience an Adverse Event (AE); time frame: Up to approximately 39 months
- Number of Participants Who Discontinue Study Drug Due to an AE; time frame: Up to approximately 39 months
,"France; Germany; Hungary; Japan; Korea, Republic of; Russian Federation; Spain; Taiwan, Province of China; United States",[---]* Haar,2016-09-30,NA,840,NA,"- Has histologically confirmed diagnosis of RCC with clear cell component with or
without sarcomatoid features.
- Has locally advanced/metastatic disease (i.e., Stage IV RCC per American Joint
Committee on Cancer) or has recurrent disease.
- Has measurable disease per RECIST 1.1 as assessed by the investigator/site
radiologist.
- Has received no prior systemic therapy for advanced RCC.
- Has provided archival tumor tissue sample or newly obtained core or excisional biopsy
of a tumor lesion not previously irradiated.
- Has Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to
randomization.
- If receiving bone resorptive therapy (including but not limited to bisphosphonate or
RANK-L inhibitor) must have been on stable doses for 4 weeks prior to randomization.
- Demonstrates adequate organ function.
- Female participants of childbearing potential must be willing to use an adequate
method of contraception for the course of the study through 120 days after the last
dose of study drug.
- Male participants of childbearing potential must agree to use an adequate method of
contraception, starting with the first dose of study drug through 120 days after the
last dose of study drug.
","- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to randomization.
- Has had major surgery within 4 weeks prior to randomization or radiation therapy
within 2 weeks prior to randomization, or who has not recovered (i.e., ≤ Grade 1 or
at baseline) from AEs due to prior treatment.
- Has had prior treatment with any anti-programmed cell death (anti-PD-1), or
programmed cell death ligand 1 (PD-L1), or PD-L2 agent or an antibody targeting any
other immune-regulatory receptors or mechanisms.
- Has received prior therapy with vascular endothelial growth factor (VEGF)/VEGF
receptors (VEGFR) or mechanistic target of rapamycin (mTOR) targeting agents.
- Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema,
hypotension, bronchospasm, angioedema or anaphylaxis) to axitinib or sunitinib.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to randomization, except
in the case of central nervous system (CNS) metastases.
- Has an active autoimmune disease requiring systemic treatment with in the past 3
months or a documented history of clinically severe autoimmune disease, or a syndrome
that requires systemic or immunosuppressive agents. Note: Participants with vitiligo,
diabetes Type I, resolved childhood asthma/atopy, hypothyroidism stable on hormone
replacement, or Sjøgren's syndrome are not excluded.
- Has a known additional malignancy that has progressed or has required active
treatment in the last 3 years. Note: Participants with basal cell carcinoma of the
skin, squamous cell carcinoma of the skin that has undergone potentially curative
therapy or carcinoma in situ are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B or Hepatitis C infection.
- Has received a live virus vaccine within 30 days of randomization.
- Has a clinically significant gastrointestinal (GI) abnormality including:
- Inability to take oral medication
- Requirement for intravenous alimentation
- Prior surgical procedures affecting absorption including total gastric resection
- Treatment for active peptic ulcer within the past 6 months
- Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3
months without evidence of resolution documented by endoscopy or colonoscopy
- Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease,
ulcerative colitis or other GI condition associated with increased risk of
perforation, or history of GI perforation
- Malabsorption syndromes
- Inflammatory bowel disease
- Has QT interval corrected for heart rate (QTc) ≥480 msec.
- Has a history of any of the following cardiovascular conditions within 12 months of
screening:
- Myocardial infarction
- Unstable angina pectoris
- Cardiac angioplasty or stenting
- Coronary/peripheral artery bypass graft
- Class III or IV congestive heart failure per New York Heart Association
- Cerebrovascular accident or transient ischemic attack
- Has a history of deep vein thrombosis or pulmonary embolism within 6 months of
screening.
- Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm
Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg.
- Has evidence of inadequate wound healing.
- Has active bleeding disorder or other history of significant bleeding episodes within
30 days of randomization.
- Has hemoptysis within 6 weeks prior to randomization.
- Has current use or anticipated need for treatment with drugs or foods that are known
strong cytochrome P450 (CYP3A4/5) inhibitors.
- Has current use or anticipated need for treatment with drugs that are known strong
CYP3A4/5 inducers, including but not limited to carbamazepine,
phenobarbital,phenytoin, rifabutin, rifampin, and St. John's wort.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.
- Has had a prior solid organ transplant.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study drug.
- Is, at the time of signing informed consent, a known regular user (including
""recreational use"") of any illicit drugs or had a recent history (within the last
year) of drug or alcohol abuse.
","A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)",Recruiting ongoing,Merck Sharp & Dohme Corp.; Merck Sharp & Dohme Corp.; [---]*,[---]*; [---]*; [---]*,Arm 1 Biological: Pembrolizumab; Arm 2 Drug: Axitinib; Arm 3 Drug: Sunitinib,2016-09-16,2016-07-29,2016-07-29,861,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2016,NA,TRUE,TRUE,TRUE
28772,NA,DRKS00000025,DRKS00000025,NCT: NA ICTRP: 2008-09-05 DRKS: 2008-09-05,1,NA,NA,2,NA,NA,NA,NA,NA,NA,1,NA,Only type of outcome mentioned,NA,NA,NA,NCT: NA ICTRP: 70 DRKS: Tatsächlich 70,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-09-10,NA,2003-09-30,2008-09-30,Interventional,Deflazacort in Dysferlinopathies,"Deflazacort in Dysferlinopathies (LGMD2B/MM) - a Double Blind, Placebo-controlled Clinical Study",Completed,Phase 2/Phase 3,25,Actual,Ludwig-Maximilians - University of Munich,"Muscle strength according to Medical Research Council Scales (MRC) and quantitative strength measurement evaluated by hand-held dynamometry (Citec, Groningen, The Netherlands)in the same muscle groups.","Quantitative strength measurement (QSM, M3diagnos, Fa. Schnell, Germany), Neuromuscular Symptoms Score (NSS), timed function tests, Clinical Global Impressions (CGI) of change and quality of life assessment(SF-36 scale).",274/02,Deflazacort in Dysferlinopathies,"Deflazacort in Dysferlinopathies (LGMD2B/MM) - a Double Blind, Placebo-controlled Clinical Study",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2/Phase 3,2007-09-06,2003-09-20,25,Completed,Ludwig-Maximilians - University of Munich,NULL,germany,Drug: deflazacort;Drug: placebo,"
Inclusion Criteria:
- Clinically, histologically, immunohistochemically and genetically defined muscular
dystrophy with dysferlin-deficiency (LGMD2B/MM).
- Patients should fulfill clinical, morphological, immunohistochemical and immunoblot
criteria of LGMD 2B and definite mutation in dysferlin gene.
- There is no limitation on age for study inclusion.
Exclusion Criteria:
- Patients confined to bed or wheelchair.
- Patients with other neurologic or internistic diseases and patients with former or
current steroid treatment will not be included.
- Exclusion criteria during the trial are withdrawal of informed consent or lack of
compliance.
",NULL,"Muscle strength according to Medical Research Council Scales (MRC) and quantitative strength measurement evaluated by hand-held dynamometry (Citec, Groningen, The Netherlands)in the same muscle groups.","Quantitative strength measurement (QSM, M3diagnos, Fa. Schnell, Germany), Neuromuscular Symptoms Score (NSS), timed function tests, Clinical Global Impressions (CGI) of change and quality of life assessment(SF-36 scale).",UKF000562,2008-09-05,yes,"serious community-acquired pneumonia; Pneumonia, organism unspecified",Arm 1 Klacid® therapy,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,The use of Klacid® will be documented in a high number of patients under conditions simulating practical use. Rare adverse effects shall be traced or previously known good tolerability of the drug shall be confirmed. An additional goal is to collect further data on efficacy and also the rapid onset of action.,NA,Germany,,2003-01-07,Actual,70,2005-09-14,"- One of these three signs: fever, purulent sputum, typical auscultation findings
- An infiltration in X-ray
- Start of anti-infective therapy with Klacid within 24 hours after admission
- The diagnosis is: community acquired",- Pretreatment with Klacid
- Transfer from another hospital,Klacid – postmarketing observational study in patients with serious community-acquired pneumonia,"Recruiting complete, follow-up complete",ABBOTT GmbH & Co. KG; Institut für Umweltmedizin und Krankenshaushygiene
Universitätsklinik Freiburg; Institut für Umweltmedizin und Krankenshaushygiene
Universitätsklinik Freiburg,[---]*; Franz.Daschner@uniklinik-freiburg.de; Franz.Daschner@uniklinik-freiburg.de,Arm 1 Klacid® therapy,2003-09-30,2007-09-06,2007-09-06,25,Interventional,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2003,NA,TRUE,TRUE,FALSE
26988,NA,DRKS00004434,DRKS00004434,NCT: NA ICTRP: 2012-10-04 DRKS: 2012-10-04,1,1,NA,1,1,a,criteria more specific in article,NA,NA,NA,3,1,"no AM, no measure",1,1,"no AM, no metric, no measure, no time frame",NCT: NA ICTRP: 20 DRKS: Tatsächlich 20,10,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,ganzer Artikel,https://doi.org/10.1016/j.jcrc.2016.11.001,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,15/04/2012,Computerised automatic lung CT region-of interest analysis and segmentation / Auto-ROI study,Computerised automatic lung CT region-of interest analysis and segmentation / Auto-ROI study ,omoerer@med.uni-goettingen.de,omoerer@med.uni-goettingen.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Diagnostic;,N/A,2012-10-04,2012-05-28,20,Recruiting,"ZARI , UMG Göttingen",NULL,germany,Intervention 1: only one arm since study is an observational study.
All patients with ARDS and a lung CT scan can be recruited into the study. Automatic and manual lung CT analyses are performed and results compared.,Inclusion criteria: ARDS (acute)
Consent to study given
Lung CT scan performed before study recruitment,"Exclusion criteria: lack of consent
preexisting severe lung disease (COPD, asthma)
gravidity","Accuracy of analysis: a comparison between manually analysed data and automotically generated data is being made. Apart from lung density, lung aereation, amount of overdistended lung tissue, amount of atelectatic lung areas and others are being compared.",Speed of analysis,,2012-10-04,yes,ARDS; Adult respiratory distress syndrome,Arm 1 only one arm since study is an observational study.
All patients with ARDS and a lung CT scan can be recruited into the study. Automatic and manual lung CT analyses are performed and results compared.,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Accuracy of analysis: a comparison between manually analysed data and automotically generated data is being made. Apart from lung density, lung aereation, amount of overdistended lung tissue, amount of atelectatic lung areas and others are being compared.",Speed of analysis,Germany,University Medical Center Göttingen,2012-05-28,Actual,20,NA,ARDS (acute)
Consent to study given
Lung CT scan performed before study recruitment,"lack of consent
preexisting severe lung disease (COPD, asthma)
gravidity",Computerised automatic lung CT region-of interest analysis and segmentation / Auto-ROI study ,Recruiting ongoing,"ZARI , UMG Göttingen; ZARI , UMG Göttingen; ZARI , UMG Göttingen",omoerer@med.uni-goettingen.de; omoerer@med.uni-goettingen.de; omoerer@med.uni-goettingen.de,Arm 1 only one arm since study is an observational study.
All patients with ARDS and a lung CT scan can be recruited into the study. Automatic and manual lung CT analyses are performed and results compared.,2012-05-28,NA,2012-10-04,20,Observational,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2012,NA,FALSE,TRUE,FALSE
27575,NA,DRKS00003395,DRKS00003395,NCT: NA ICTRP: 2012-01-17 DRKS: 2012-01-17,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,1,NA,"no AM, no metric, no time frame, no measure",NCT: NA ICTRP: 12 DRKS: Tatsächlich 12,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,U1111-1126-3904;DRKS00003493;F-2011-006,Impact of dietary fat intake on bioavailability and lipoprotein-associated transport of isoflavones in postmenopausal women,Impact of dietary fat intake on bioavailability and lipoprotein-associated transport of isoflavones in postmenopausal women ,achim.bub@mri.bund.de,anita.kriebel@mri.bund.de,Interventional,"Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject, investigator/therapist, caregiver). Control: Placebo|Active control. Assignment: Crossover. Study design purpose: Basic research/physiological study;",N/A,2012-01-17,2012-01-16,12,Recruiting,Max Rubner-Institut,NULL,germany,"Intervention 1: controlled diet according to 20% energy fom fat of consumed food, as well as isoflavones following placebo Intervention 2: controlled diet according to 40% energy fom fat of consumed food, as well as isoflavones following placebo",Inclusion criteria: postmenopausal women under the age of 75 years; mean BMI of 25 kg/m2; non-smoker; study participants who gave written consent,"Exclusion criteria: hormone replacement therapy; history of breast cancer; serious health problems related to nutrient absorption, digestion, metabolism or excretion; women taking nutritional supplements or on medication during the past 3 months, which may interact with study parameters; participants who are supposed to be not complient;","Isoflavon plasma concentrations (LC-MS/MS), weekly",isoflavone metabolites in body fluids,U1111-1126-3904; DRKS00003493,2012-01-17,yes,"healthy volunteers; Menopausal and perimenopausal disorder, unspecified","Arm 1 controlled diet according to 20% energy fom fat of consumed food, as well as isoflavones following placebo; Arm 2 controlled diet according to 40% energy fom fat of consumed food, as well as isoflavones following placebo",Interventional,Randomized controlled trial,Blinded,Placebo|Active control,Crossover,N/A,"Isoflavon plasma concentrations (LC-MS/MS), weekly",isoflavone metabolites in body fluids,Germany,,2012-01-16,Actual,12,NA,postmenopausal women under the age of 75 years; mean BMI of 25 kg/m2; non-smoker; study participants who gave written consent ,"hormone replacement therapy; history of breast cancer; serious health problems related to nutrient absorption, digestion, metabolism or excretion; women taking nutritional supplements or on medication during the past 3 months, which may interact with study parameters; participants who are supposed to be not complient; ",Impact of dietary fat intake on bioavailability and lipoprotein-associated transport of isoflavones in postmenopausal women,Recruiting ongoing,Max Rubner-Institut; Max Rubner-Institut; Max Rubner-Institut,achim.bub@mri.bund.de; achim.bub@mri.bund.de; anita.kriebel@mri.bund.de,"Arm 1 controlled diet according to 20% energy fom fat of consumed food, as well as isoflavones following placebo; Arm 2 controlled diet according to 40% energy fom fat of consumed food, as well as isoflavones following placebo",2012-01-16,NA,2012-01-17,12,Interventional,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2012,NA,FALSE,TRUE,FALSE
23026,NA,DRKS00011408,DRKS00011408,NCT: NA ICTRP: 2016-12-14 DRKS: 2016-12-14,0,NA,"Does not seem to be interventional, will not rate Int-Q",2,NA,NA,NA,NA,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 60 DRKS: Geplant 60,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,443/16,Loaded Knee MRI of the patellofemoral joint in patients with patella instability using prospective motion correction,Loaded Knee MRI of the patellofemoral joint in patients with patella instability using prospective motion correction - PatInstab ,kaywan.izadpanah@uniklnik-freiburg.de,kaywan.izadpanah@uniklnik-freiburg.de,Interventional,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Prognosis;,N/A,2016-12-14,2017-02-01,60,Pending,Klinik für Orthopädie und Unfallchirurgie Uniklinik Freiburg,NULL,germany,"Intervention 1: In Patients, undergoing operative stabilization of the Patella before and after operative treatment a dynamic MRI of the knee joint, determining patellorfemoral kinematics will be carried out. Intervention 2: Healthy people with a dynamic MRI of the knee joint, determining patellorfemoral kinematics will be carried out.",Inclusion criteria: Patients age >18 and < 55 years
Patients suffering from persistent subjective or objective patellofemoral instability after Patellaluxation
Patients undergoing operative Treatment for patella stabilization,"Exclusion criteria: Knee arthrosis Grade 2 (Kellgren and Lawrence system)
Chronic drug abuse
Patients carrying, artifical heart waves, heart pacemaker, other ferromagnetic implants","4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:
Size of patellofemoral cartialge contact area will be determined using MRI at 0,10,20,30° of flexion.","4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:
•Influence of patellar stabilization on patellofemoral kinematics, determined using MRI at 0,10,20,30° of flexion
•Measure of cartilage compression,determined using MRI at 0,10,20,30° of flexion
•Measure of cartialge relaxation times,determined using MRI at 0,10,20,30° of flexion",,2016-12-14,no,Recurrent dislocation of patella; Recurrent subluxation of patella,"Arm 1 In Patients, undergoing operative stabilization of the Patella before and after operative treatment a dynamic MRI of the knee joint, determining patellorfemoral kinematics will be carried out. ; Arm 2 Healthy people with a dynamic MRI of the knee joint, determining patellorfemoral kinematics will be carried out. ",Interventional,Non-randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,N/A,"4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:
Size of patellofemoral cartialge contact area will be determined using MRI at 0,10,20,30° of flexion.","4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:
•Influence of patellar stabilization on patellofemoral kinematics, determined using MRI at 0,10,20,30° of flexion
•Measure of cartilage compression,determined using MRI at 0,10,20,30° of flexion
•Measure of cartialge relaxation times,determined using MRI at 0,10,20,30° of flexion
",Germany,Medical Center Freiburg im Breisgau,2017-02-01,Planned,60,NA,Patients age >18 and < 55 years
Patients suffering from persistent subjective or objective patellofemoral instability after Patellaluxation
Patients undergoing operative Treatment for patella stabilization
,"
Knee arthrosis Grade 2 (Kellgren and Lawrence system)
Chronic drug abuse
Patients carrying, artifical heart waves, heart pacemaker, other ferromagnetic implants ",Loaded Knee MRI of the patellofemoral joint in patients with patella instability using prospective motion correction,Recruiting planned,Klinik für Orthopädie und Unfallchirurgie Uniklinik Freiburg; Klinik für Orthopädie und Unfallchirurgie Uniklinik Freiburg; Klinik für Orthopädie und Unfallchirurgie Uniklinik Freiburg,kaywan.izadpanah@uniklnik-freiburg.de; kaywan.izadpanah@uniklnik-freiburg.de; kaywan.izadpanah@uniklnik-freiburg.de,"Arm 1 In Patients, undergoing operative stabilization of the Patella before and after operative treatment a dynamic MRI of the knee joint, determining patellorfemoral kinematics will be carried out. ; Arm 2 Healthy people with a dynamic MRI of the knee joint, determining patellorfemoral kinematics will be carried out. ",2017-02-01,NA,2016-12-14,60,Interventional,FALSE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2017,NA,FALSE,TRUE,FALSE
26778,NA,DRKS00004010,DRKS00004010,NCT: NA ICTRP: 2012-12-19 DRKS: 2012-12-19,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no measure,4,NA,no measure,NCT: NA ICTRP: 75 DRKS: [---]* 75,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,Review,10.1200/jco.2015.33.15_suppl.4033,NA,2012-01-04,NA,2011-11-30,2017-12-14,Interventional,FLO +/- Pazopanib as First-line Treatment in Advanced Gastric Cancer,"Pazopanib With 5-Fluorouracil, Leucovorin and Oxaliplatin (FLO) as 1st-line Treatment in Advanced Gastric Cancer; a Randomized Phase-II-study of the Arbeitsgemeinschaft Internistische Onkologie",Completed,Phase 2,75,Actual,"Charite University, Berlin, Germany",progression-free survival rate at 6 months,progression-free survival rate at 9 and 12 months;median progression-free survival;response rate;duration of response;toxicity;tolerability;overall survival;time to treatment failure;evaluation of the predictive and prognostic relevance of biomarkers,2010-024379-15;PaFLO,FLO +/- Pazopanib as First-line Treatment in Advanced Gastric Cancer,"Pazopanib With 5-Fluorouracil, Leucovorin and Oxaliplatin (FLO) as 1st-line Treatment in Advanced Gastric Cancer; a Randomized Phase-II-study of the Arbeitsgemeinschaft Internistische Onkologie",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2011-12-22,2011-11-20,75,Completed,"Charite University, Berlin, Germany",NULL,germany,"Drug: Pazopanib;Drug: 5-FU, Oxaliplatin, Leukovorin (FLO)","
Inclusion Criteria:
- Subjects must provide written informed consent prior to performance of study-specific
procedures or assessments, and must be willing to comply with treatment and follow up.
- Age = 18 years.
- Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal
junction with either metastatic or locally advanced disease, incurable by operation.
- Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2
- At least one unidimensional, measurable tumor parameter (according to RECIST 1.1)
- No preceding cytotoxic therapy (neoadjuvant or adjuvant treatment allowed if finished
> 6 months before inclusion)
- Adequate organ system function.
- Men and women must perform an adequate contraception.
- Female subjects who are lactating should discontinue nursing prior to the first dose
of study drug and should refrain from nursing throughout the treatment period and for
14 days following the last dose of study drug.
Exclusion Criteria:
- Prior malignancy, except for curatively treated basal cell carcinoma of the skin and
in situ carcinoma of the cervix.
- Overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive.
- Known hypersensitivity against 5-FU, leukovorin, oxaliplatin or other platinum
compounds or pazopanib.
- History or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis.
- Clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding or the absorption of investigational product
- Presence of uncontrolled infection.
- Corrected QT interval (QTc) > 480 ms using Bazett's formula.
- History of any one or more of the following cardiovascular conditions within the past
6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina,
coronary artery bypass graft surgery, symptomatic peripheral vascular disease, NYHA
III or IV congestive heart failure.
- Poorly controlled hypertension.
- History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding diathesis.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
- Hemoptysis in excess of 2.5 ml within 8 weeks of first dose of study drug.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that
could interfere with subject's safety, provision of informed consent, or compliance to
study procedures.
- Unable or unwilling to discontinue use of prohibited medications for at least 14 days
or five half-lives of a drug (whichever is longer) prior to the first dose of study
drug and for the duration of the study.
- Treatment with any of the following anti-cancer therapies: radiation therapy, surgery
or tumor embolization within 14 days prior to the first dose of pazopanib OR
chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal
therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the
first dose of pazopanib. A neoadjuvant or adjuvant chemotherapy must be finished at
least 6 month before study entry.
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is
progressing in severity, except alopecia.
- Grade 3 or 4 diarrhea.
- Peripheral polyneuropathy > NCI Grade.
- Pregnant or lactating women.
- Men or women who are planning a pregnancy within the next six months.
- Participation in another clinical trial with investigational agents within the last 30
days prior to study start.
- The patient is a colleague or employed by the study investigator or by an involved
institution including the sponsor of the study.
- Patient is detained in a psychiatric unit or imprisoned.
",NULL,progression-free survival rate at 6 months,progression-free survival rate at 9 and 12 months;median progression-free survival;response rate;duration of response;toxicity;tolerability;overall survival;time to treatment failure;evaluation of the predictive and prognostic relevance of biomarkers,2010-024379-15; NCT01503372; PaFLO; 2010-024379-15,2012-12-19,yes,Advanced Gastric Cancer; Malignant neoplasm of stomach,"Arm 1 Drug: Pazopanib; Arm 2 Drug: 5-FU, Oxaliplatin, Leukovorin (FLO)",Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,II,- progression-free survival rate at 6 months; time frame: 6 months after study entry
,- progression-free survival rate at 9 and 12 months; time frame: 9 and 12 months after study entry
- median progression-free survival; time frame: 48 months
- response rate; time frame: 48 months
- duration of response; time frame: 48 months
- toxicity; time frame: 48 months; number of patients with Adverse Events according to CTC-criteria
- tolerability; time frame: 48 months; number of patients having adverse events and require interruptions and dose reductions of chemotherapy
- overall survival; time frame: 48 months
- time to treatment failure; time frame: 48 months
- evaluation of the predictive and prognostic relevance of biomarkers; time frame: 48 months; collection of plasma samples at designated time points during treatment and measuring of angiogenic factors correlating with response rate and outcome
,Germany,[---]* Berlin,2011-11-30,NA,75,NA,"- Subjects must provide written informed consent prior to performance of study-specific
procedures or assessments, and must be willing to comply with treatment and follow
up.
- Age ≥ 18 years.
- Histologically confirmed adenocarcinoma of the stomach or the gastroesophageal
junction with either metastatic or locally advanced disease, incurable by operation.
- Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2
- At least one unidimensional, measurable tumor parameter (according to RECIST 1.1)
- No preceding cytotoxic therapy (neoadjuvant or adjuvant treatment allowed if finished
> 6 months before inclusion)
- Adequate organ system function.
- Men and women must perform an adequate contraception.
- Female subjects who are lactating should discontinue nursing prior to the first dose
of study drug and should refrain from nursing throughout the treatment period and for
14 days following the last dose of study drug.
","- Prior malignancy, except for curatively treated basal cell carcinoma of the skin and
in situ carcinoma of the cervix.
- Overexpression of HER-2, defined as IHC 3+ or IHC 2+ and FISH positive.
- Known hypersensitivity against 5-FU, leukovorin, oxaliplatin or other platinum
compounds or pazopanib.
- History or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis.
- Clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding or the absorption of investigational product
- Presence of uncontrolled infection.
- Corrected QT interval (QTc) > 480 ms using Bazett's formula.
- History of any one or more of the following cardiovascular conditions within the past
6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina,
coronary artery bypass graft surgery, symptomatic peripheral vascular disease, NYHA
III or IV congestive heart failure.
- Poorly controlled hypertension.
- History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6
months.
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer.
- Evidence of active bleeding or bleeding diathesis.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels.
- Hemoptysis in excess of 2.5 ml within 8 weeks of first dose of study drug.
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with subject's safety, provision of informed consent, or
compliance to study procedures.
- Unable or unwilling to discontinue use of prohibited medications for at least 14 days
or five half-lives of a drug (whichever is longer) prior to the first dose of study
drug and for the duration of the study.
- Treatment with any of the following anti-cancer therapies: radiation therapy, surgery
or tumor embolization within 14 days prior to the first dose of pazopanib OR
chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal
therapy within 14 days or five half-lives of a drug (whichever is longer) prior to
the first dose of pazopanib. A neoadjuvant or adjuvant chemotherapy must be finished
at least 6 month before study entry.
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is
progressing in severity, except alopecia.
- Grade 3 or 4 diarrhea.
- Peripheral polyneuropathy > NCI Grade.
- Pregnant or lactating women.
- Men or women who are planning a pregnancy within the next six months.
- Participation in another clinical trial with investigational agents within the last
30 days prior to study start.
- The patient is a colleague or employed by the study investigator or by an involved
institution including the sponsor of the study.
- Patient is detained in a psychiatric unit or imprisoned.
","Pazopanib With 5-Fluorouracil, Leucovorin and Oxaliplatin (FLO) as 1st-line Treatment in Advanced Gastric Cancer; a Randomized Phase-II-study of the Arbeitsgemeinschaft Internistische Onkologie",Recruiting ongoing,"Charite University, Berlin, Germany; Charite University medicine; [---]*",[---]*; [---]*; magenkarzinom@charite.de,"Arm 1 Drug: Pazopanib; Arm 2 Drug: 5-FU, Oxaliplatin, Leukovorin (FLO)",2011-11-30,2011-12-22,2011-12-22,75,Interventional,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2011,NA,TRUE,TRUE,TRUE
22293,NA,DRKS00011625,DRKS00011625,NCT: NA ICTRP: 2017-08-09 DRKS: 2017-08-09,1,NA,NA,2,NA,NA,NA,NA,NA,NA,2,NA,"no AM, no time frame, no measure",3,NA,"no AM, no time frame",NCT: NA ICTRP: 260 DRKS: Tatsächlich 260,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,96/17,Optimizing Teamwork by training Teamcoaches in Multi-Team-Systems of Rehabilitation Medicine,Optimizing Teamwork by training Teamcoaches in Multi-Team-Systems of Rehabilitation Medicine - TOp- Team ,mirjam.koerner@mps.uni-freiburg.de,mirjam.koerner@mps.uni-freiburg.de,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Prevention;,N/A,2017-08-09,2018-01-01,260,Complete: follow-up complete,Deutsche Rentenversicherung Bund (DRV- Bund),NULL,germany,"Intervention 1: Based on a review of the literature and a manual that was developed in a former study, a training will be developed that enables teamleaders of rehabilitation clinics to act as team coaches in their teams. All participating teamleaders wil receive training, which will be evaluated by a questionnaire and interviews. They will apply the trained coaching tools in their teams. Members of the teams will be observed and questioned (by interviews and questionnaires) regarding teamwork parameters in order to measure the coachings' effects and mechanisms of change.","Inclusion criteria: German-speaking, age between 18 and 65, member of the rehabilitation team","Exclusion criteria: not German-speaking, not member of the rehabilitation team, age <18 years","Teamwork, measured by a questionnaire before and after the training (i.e. questionnaire on teamwork by Kauffeld)","mechanisms of change of the training, measured by qualitative interviews with the trainers, the team and the team members. Analyzed by qualitative content analysis.",,2017-08-09,yes,Staff health,"Arm 1 Based on a review of the literature and a manual that was developed in a former study, a training will be developed that enables teamleaders of rehabilitation clinics to act as team coaches in their teams. All participating teamleaders wil receive training, which will be evaluated by a questionnaire and interviews. They will apply the trained coaching tools in their teams. Members of the teams will be observed and questioned (by interviews and questionnaires) regarding teamwork parameters in order to measure the coachings' effects and mechanisms of change.",Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Teamwork, measured by a questionnaire before and after the training (i.e. questionnaire on teamwork by Kauffeld)","mechanisms of change of the training, measured by qualitative interviews with the trainers, the team and the team members. Analyzed by qualitative content analysis.",Germany,Medical Center Freiburg im Breisgau,2018-01-01,Actual,260,2019-06-30,"German-speaking, age between 18 and 65, member of the rehabilitation team","not German-speaking, not member of the rehabilitation team, age <18 years",Optimizing Teamwork by training Teamcoaches in Multi-Team-Systems of Rehabilitation Medicine,"Recruiting complete, follow-up complete","Deutsche Rentenversicherung Bund (DRV- Bund); Albert- Ludwigs- Universität Freiburg, Medizinische Psychologie und Medizinische Soziologie; Albert- Ludwigs- Universität Freiburg, Medizinische Psychologie und Medizinische Soziologie",[---]*; mirjam.koerner@mps.uni-freiburg.de; mirjam.koerner@mps.uni-freiburg.de,"Arm 1 Based on a review of the literature and a manual that was developed in a former study, a training will be developed that enables teamleaders of rehabilitation clinics to act as team coaches in their teams. All participating teamleaders wil receive training, which will be evaluated by a questionnaire and interviews. They will apply the trained coaching tools in their teams. Members of the teams will be observed and questioned (by interviews and questionnaires) regarding teamwork parameters in order to measure the coachings' effects and mechanisms of change.",2018-01-01,NA,2017-08-09,260,Interventional,FALSE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,TRUE,TRUE,2018,NA,FALSE,TRUE,FALSE
27684,NA,DRKS00003324,DRKS00003324,NCT: NA ICTRP: 2011-11-11 DRKS: 2011-11-11,0,NA,Trial seems to be observational instead of interventional,1,NA,NA,NA,2,NA,NA,4,NA,"no measure (""Efficiency"")",5,NA,NA,NCT: NA ICTRP: 220 DRKS: Tatsächlich 220,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-001819-30;4037502;5038/11,Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy(Hypericin PDD),Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy(Hypericin PDD) ,Sano2011@sanochemia.at,Sano2011@sanochemia.at,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Active control. Assignment: Single (group). Study design purpose: Diagnostic;,IIb,2011-11-11,2011-11-16,220,Complete: follow-up complete,Sanochemia Pharmazeutika AG,NULL,germany;austria,"Intervention 1: PVP-Hypericin instillation (225µg Hypericin) for 30+5 minutes, subsequently cystoscopy with white light followed by cystoscopy with blue light",Inclusion criteria: 1. Patients who have given their signed declaration of consent and data
protection declaration
2. Males and females aged = 18 years
3. Patients scheduled for transurethral resection of the bladder of a suspected bladder
cancer based on recent findings in cystoscpy that have to be diagnosed at the respective study site prior to Visit 1
4. Patients including multiple baldder tumours or suspicious lesions
5. Patients with initial and/or recurrent bladder cancer
6. Patients with adequate renal and hepatic function according to the
investigator
7. No known anaesthetic risks (risk of narcosis ASA 1-3)
8. All women of child-bearing potential must have a negative serum or
urine pregnancy test at screening and must use hormonal contraception
or intrauterine device (IUD) during the treatment and for at least one
month thereafter.,"Exclusion criteria: 1. Intravesical BCG (Bacillus Calmette-Guérin) instillation = 6 months
2. Intravesical Mitomycin instillation = 3 months
3. Patients at high risk of suffering extensive bladder inflammation
4. Recent bladder surgery (resection) = 3 months
5. Patients with symptoms and signs of urinary tract infection, e.g.
moderate or severe leukocyturia, dysuria, alguria, urgency, frequency,
polyuria, offensive urine, cloudy urine, significant bacteriuria (= 100000
CFU/mL), positive urine culture, asymptomatic bacteriuria, suprapubic
tenderness, pain or pressure, flank or back pain, fever = 38°C,
costovertebral angle tenderness
6. Macroscopic hematuria
7. Bladder stones
8. Bladder capacity = 50 mL
9. Administration of any other photosensitiser < 6 months
10. Oral intake of any drug or substance containing Hypericum extract,
Hypericin, Pseudohypericin or parts of Hypericum plants (capsules,
tablets, powder, drops, teas, etc.) within 14 days prior to PDD, during the study and until
Visit 4 for patients included in the PK subgroup
11. All anticoagulation therapy except low dose heparin and aspirin
12. Known allergy to Hypericin, polyvinylpyrrolidone (PVP, povidone) or
any similar compounds
13. Pregnant or breast-feeding women
14. Participation in other clinical studies with investigational drugs
either concurrently or within the last 30 days
15. Previous participation in this clinical study
16. Conditions associated with a risk of poor protocol compliance
17. Patients with mental health problems
18. Patients who have difficulties in understanding the language in
which the patient information is given
19. Legal incapacity and/or other circumstances rendering the patient
unable to understand the nature, scope and possible impact of the study
20. Patients in custody by juridical or official order
21. Staff of the study centre, staff of the sponsor or CRO, the
investigator him-/herself or close relatives of the investigator","To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by
inspecting the bladder under white light first, followed by blue light. Diagnostic performance is confirmed by biopsy.",• Diagnostic performance regarding flat and papillary tumours
• False-positive rate
• To evaluate systemic absorption and pharmacokinetics (PK) of
Hypericin after a single intravesical instillation of PVP-Hypericin in a
sub-group of patients (N=15-20)
• To assess the safety of PVP-Hypericin (data collection of adverse events),2011-001819-30; 4037502,2011-11-11,no,Malignant neoplasm of bladder; [---]*,"Arm 1 PVP-Hypericin instillation (225µg Hypericin) for 30+5 minutes, subsequently cystoscopy with white light followed by cystoscopy with blue light",Interventional,Single arm study,Open (masking not used),Active control,Single (group),IIb,"To collect preliminary data on the diagnostic performance of Hypericin-guided cystoscopy regarding the detection of non-muscle invasive bladder cancer . Standard, white light cystoscopy will be compared with Hypericin assisted cystoscopy (PVP-Hypericin instillation; white light followed by blue light (Hypericin PDD)) using a within-patient design by
inspecting the bladder under white light first, followed by blue light. Diagnostic performance is confirmed by biopsy.",• Diagnostic performance regarding flat and papillary tumours
• False-positive rate
• To evaluate systemic absorption and pharmacokinetics (PK) of
Hypericin after a single intravesical instillation of PVP-Hypericin in a
sub-group of patients (N=15-20)
• To assess the safety of PVP-Hypericin (data collection of adverse events),Germany; Austria,,2011-11-16,Actual,220,2014-07-19,1. Patients who have given their signed declaration of consent and data
protection declaration
2. Males and females aged ≥ 18 years
3. Patients scheduled for transurethral resection of the bladder of a suspected bladder
cancer based on recent findings in cystoscpy that have to be diagnosed at the respective study site prior to Visit 1
4. Patients including multiple baldder tumours or suspicious lesions
5. Patients with initial and/or recurrent bladder cancer
6. Patients with adequate renal and hepatic function according to the
investigator
7. No known anaesthetic risks (risk of narcosis ASA 1-3)
8. All women of child-bearing potential must have a negative serum or
urine pregnancy test at screening and must use hormonal contraception
or intrauterine device (IUD) during the treatment and for at least one
month thereafter.,"1. Intravesical BCG (Bacillus Calmette-Guérin) instillation ≤ 6 months
2. Intravesical Mitomycin instillation ≤ 3 months
3. Patients at high risk of suffering extensive bladder inflammation
4. Recent bladder surgery (resection) ≤ 3 months
5. Patients with symptoms and signs of urinary tract infection, e.g.
moderate or severe leukocyturia, dysuria, alguria, urgency, frequency,
polyuria, offensive urine, cloudy urine, significant bacteriuria (≥ 100000
CFU/mL), positive urine culture, asymptomatic bacteriuria, suprapubic
tenderness, pain or pressure, flank or back pain, fever ≥ 38°C,
costovertebral angle tenderness
6. Macroscopic hematuria
7. Bladder stones
8. Bladder capacity ≤ 50 mL
9. Administration of any other photosensitiser < 6 months
10. Oral intake of any drug or substance containing Hypericum extract,
Hypericin, Pseudohypericin or parts of Hypericum plants (capsules,
tablets, powder, drops, teas, etc.) within 14 days prior to PDD, during the study and until
Visit 4 for patients included in the PK subgroup
11. All anticoagulation therapy except low dose heparin and aspirin
12. Known allergy to Hypericin, polyvinylpyrrolidone (PVP, povidone) or
any similar compounds
13. Pregnant or breast-feeding women
14. Participation in other clinical studies with investigational drugs
either concurrently or within the last 30 days
15. Previous participation in this clinical study
16. Conditions associated with a risk of poor protocol compliance
17. Patients with mental health problems
18. Patients who have difficulties in understanding the language in
which the patient information is given
19. Legal incapacity and/or other circumstances rendering the patient
unable to understand the nature, scope and possible impact of the study
20. Patients in custody by juridical or official order
21. Staff of the study centre, staff of the sponsor or CRO, the
investigator him-/herself or close relatives of the investigator",Detection of non-muscle invasive bladder cancer using PVP-Hypericin (Vidon®) fluorescence cystoscopy
(Hypericin PDD),"Recruiting complete, follow-up complete","Sanochemia Pharmazeutika AG; Sanochemia Pharmazeutika AG; Urologische Klinik und Poliklinik, Klinikum rechts der Isar der Technischen Universität München; Sanochemia Pharmazeutika AG",Sano2011@sanochemia.at; Sano2011@sanochemia.at; michael.straub@lrz.tum.de; Sano2011@sanochemia.at,"Arm 1 PVP-Hypericin instillation (225µg Hypericin) for 30+5 minutes, subsequently cystoscopy with white light followed by cystoscopy with blue light",2011-11-16,NA,2011-11-11,220,Interventional,FALSE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,TRUE,TRUE,2011,NA,FALSE,TRUE,FALSE
27273,NA,DRKS00003973,DRKS00003973,NCT: NA ICTRP: 2012-05-16 DRKS: 2012-05-16,1,NA,NA,1,NA,NA,NA,1,NA,NA,3,NA,"no metric, no time frame",NA,NA,NA,NCT: NA ICTRP: 60 DRKS: Tatsächlich 60,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,U1111-1130-7818;140/12,"Analysis of pressure and flow characteristics in children using either machine-guided, pressure controlled mask ventilation or manual mask ventilation","Analysis of pressure and flow characteristics in children using either machine-guided, pressure controlled mask ventilation or manual mask ventilation - DFP ",ulrich.goebel@uniklinik-freiburg.de,ulrich.goebel@uniklinik-freiburg.de,Interventional,"Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject, assessor). Control: Active control. Assignment: Crossover. Study design purpose: Prevention;",N/A,2012-05-16,2012-07-03,60,Complete: follow-up complete,Anästhesiologische Universitätsklinik,NULL,germany,Intervention 1: just manual mask ventilation Intervention 2: mask ventilation via anesthesia machine,Inclusion criteria: every Patient with age below 12 years requiring general anesthesia,"Exclusion criteria: GERD, non-conpliance",Maxima of flow and pressure: Comparison between manual and machine ventilation,NULL,U1111-1130-7818,2012-05-16,yes,ventilation during induction of anesthesia,Arm 1 just manual mask ventilation; Arm 2 mask ventilation via anesthesia machine,Interventional,Randomized controlled trial,Blinded,Active control,Crossover,N/A,Maxima of flow and pressure: Comparison between manual and machine ventilation
,NA,Germany,University Medical Center Freiburg im Breisgau,2012-07-03,Actual,60,2013-08-01,every Patient with age below 12 years requiring general anesthesia ,"GERD, non-conpliance
","Analysis of pressure and flow characteristics in children using either machine-guided, pressure controlled mask ventilation or manual mask ventilation
","Recruiting complete, follow-up complete",Anästhesiologische Universitätsklinik; Anästhesiologische Universitätsklinik; Anästhesiologische Universitätsklinik,ulrich.goebel@uniklinik-freiburg.de; ulrich.goebel@uniklinik-freiburg.de; ulrich.goebel@uniklinik-freiburg.de,Arm 1 just manual mask ventilation; Arm 2 mask ventilation via anesthesia machine,2012-07-03,NA,2012-05-16,60,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,2012,NA,FALSE,TRUE,FALSE
22805,NA,DRKS00011205,DRKS00011205,NCT: NA ICTRP: 2017-02-21 DRKS: 2017-02-21,1,NA,NA,1,NA,NA,NA,NA,NA,NA,2,NA,"no time frame, no metric, no AM",1,NA,"no AM, no metric, no measure, no time frame",NCT: NA ICTRP: 20 DRKS: Tatsächlich 20,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no indication,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,16-458,Cellular immunity after alemtuzumab,Cellular immunity after alemtuzumab - ZINA ,helmar.lehmann@uk-koeln.de,helmar.lehmann@uk-koeln.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Treatment;,N/A,2017-02-21,2017-02-27,20,Recruiting,Universitätsklinikum Köln,NULL,germany,Intervention 1: We will include 20 multiple sclerosis patients that are planned for alemtuzumab therapy in our study.
For one year we will analyze monthly additional lab parameters during the mandatory blood drawls.,Inclusion criteria: Multiple Sclerosis patients starting therapy with alemtuzumab,Exclusion criteria: revocation of consent and underage patients,"Analysis of innate immune cells and inflammatory mediators after Alemtuzumab therapy
(primary endpoint: macrophage populations, macrophage polarizations with immunohistochemistry and flow cytomerty,",secondary endpoint: inflammatory parameters and mediators in the blood),,2017-02-21,yes,Multiple sclerosis,Arm 1 We will include 20 multiple sclerosis patients that are planned for alemtuzumab therapy in our study.
For one year we will analyze monthly additional lab parameters during the mandatory blood drawls.
,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Analysis of innate immune cells and inflammatory mediators after Alemtuzumab therapy
(primary endpoint: macrophage populations, macrophage polarizations with immunohistochemistry and flow cytomerty,
",secondary endpoint: inflammatory parameters and mediators in the blood)
,Germany,University Medical Center Köln,2017-02-27,Actual,20,NA,Multiple Sclerosis patients starting therapy with alemtuzumab
,revocation of consent and underage patients,Cellular immunity after alemtuzumab,Recruiting ongoing,Universitätsklinikum Köln; Universitätsklinikum Köln; Universitätsklinikum Köln,[---]*; helmar.lehmann@uk-koeln.de; helmar.lehmann@uk-koeln.de,Arm 1 We will include 20 multiple sclerosis patients that are planned for alemtuzumab therapy in our study.
For one year we will analyze monthly additional lab parameters during the mandatory blood drawls.
,2017-02-27,NA,2017-02-21,20,Observational,TRUE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,2017,NA,FALSE,TRUE,FALSE
24568,NA,DRKS00008980,DRKS00008980,NCT: NA ICTRP: 2015-07-30 DRKS: 2015-07-30,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",3,NA,"no AM, no measure",NCT: NA ICTRP: 60 DRKS: Geplant 60,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,4433-04/15,Mobility improved after stroke when a robotic device was used in comparison to physical therapy - The MOST Study,Mobility improved after stroke when a robotic device was used in comparison to physical therapy - The MOST Study - MOST Study ,farsin.hamzei@moritz-klinik.de,farsin.hamzei@moritz-klinik.de,Interventional,Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Active control. Assignment: Parallel. Study design purpose: Treatment;,III,2015-07-30,2015-10-01,60,Pending,Moritz KLinik Bad Klosterlausnitz,NULL,germany,"Intervention 1: Inervention group (IG) with Eksoskeltt (Ekso Bionics): 45 minutes daily training from monday to friday for three weeks Intervention 2: Control group (CG): 45 minutes daily training from monday to friday for three weeks in conventional physiotherapy programm which includes fasclitation, trunc controll training, at least 20min walking with personal and/or devices aid (with the exception of Ekso)",Inclusion criteria: - First ever stroke within last 3 months
- Stroke patients who are not able to walk alone,"Exclusion criteria: - Body weight above 120kg
- Orthopedic problems and spasticity which make it impossible to walk with EB
- cardio-pulmonary not tenable
- patients with aphasia, who don’t understand instructions
- patients with neglect",10m Walking Test six months after end of the training period,"At time point six months post training period
- TAP (Testbatterie für Aufmerksamkeit, test battery for attention)
- Berg Balance Test (BBT)
- Activity of Daily living (ADL) and Instrumental activity of daily living (IADL)
- Functional gait category (FAC)
- 6min walking test (6mintest)
At the end of the training period
- amount of total steps during the training period",,2015-07-30,yes,Cerebral infarction due to thrombosis of cerebral arteries; Cerebral infarction due to embolism of cerebral arteries,"Arm 1 Inervention group (IG) with Eksoskeltt (Ekso Bionics): 45 minutes daily training from monday to friday for three weeks ; Arm 2 Control group (CG): 45 minutes daily training from monday to friday for three weeks in conventional physiotherapy programm which includes fasclitation, trunc controll training, at least 20min walking with personal and/or devices aid (with the exception of Ekso) ",Interventional,Randomized controlled trial,Open (masking not used),Active control,Parallel,III,10m Walking Test six months after end of the training period
,"At time point six months post training period
- TAP (Testbatterie für Aufmerksamkeit, test battery for attention)
- Berg Balance Test (BBT)
- Activity of Daily living (ADL) and Instrumental activity of daily living (IADL)
- Functional gait category (FAC)
- 6min walking test (6mintest)
At the end of the training period
- amount of total steps during the training period",Germany,Medical Center Bad Klosterlausnitz,2015-10-01,Planned,60,NA,- First ever stroke within last 3 months
- Stroke patients who are not able to walk alone
,"- Body weight above 120kg
- Orthopedic problems and spasticity which make it impossible to walk with EB
- cardio-pulmonary not tenable
- patients with aphasia, who don’t understand instructions
- patients with neglect
",Mobility improved after stroke when a robotic device was used in comparison to physical therapy - The MOST Study,Recruiting planned,Moritz KLinik Bad Klosterlausnitz; Moritz KLinik Bad Klosterlausnitz; Moritz KLinik Bad Klosterlausnitz,farsin.hamzei@moritz-klinik.de; farsin.hamzei@moritz-klinik.de; farsin.hamzei@moritz-klinik.de,"Arm 1 Inervention group (IG) with Eksoskeltt (Ekso Bionics): 45 minutes daily training from monday to friday for three weeks ; Arm 2 Control group (CG): 45 minutes daily training from monday to friday for three weeks in conventional physiotherapy programm which includes fasclitation, trunc controll training, at least 20min walking with personal and/or devices aid (with the exception of Ekso) ",2015-10-01,NA,2015-07-30,60,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2015,NA,FALSE,TRUE,FALSE
27036,NA,DRKS00004279,DRKS00004279,NCT: NA ICTRP: 2012-09-03 DRKS: 2012-09-03,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 40 DRKS: Tatsächlich 40,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,U1111-1134-0703;EA4/063/12,"Randomized, placebo-controlled, double-blind trial to study the effects of polidocanol on experimental pruritus","Randomized, placebo-controlled, double-blind trial to study the effects of polidocanol on experimental pruritus ",martin.metz@charite.de,hesna.goezluekaya@charite.de,Interventional,"Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject, investigator/therapist). Control: Placebo. Assignment: Crossover. Study design purpose: Basic research/physiological study;",N/A,2012-09-03,2012-09-03,40,Complete: follow-up complete,Klinik für Dermatologie und AllergologieCharité - Universitätsmedizin Berlin,NULL,germany,"Intervention 1: topical 3% polidocanol solution, one time application to the skin as spray, about 1ml in total; histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds Intervention 2: placebo, one time application to the skin as spray, about 1ml in total; histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds",Inclusion criteria: Healthy individuals,"Exclusion criteria: Pregnancy, breast feeding, skin diseases, diseases of the peripheral nervous system, intake of antihistamines, NSAIDs, local anesthetics or mast cell stabilizers within 5 days prior to testing, intake of antideppressants within 14 days prior to testing, intake of steroids (topical or systemic) within 7 days prior to testing.",To assess the effect of 3% Polidocanol on pruritus induced by Mucuna pruriens (cowhage) by itch intensity (VAS) within 30 minutes after Mucuna application,"- To assess the effect of 3% Polidocanol on pruritus induced by histamine (by VAS for 30 minutes)
- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by Mucuna pruriens (cowhage). Wheal development will be assessed by measuring wheal diameter (mean of the largest diameter and the perpendicular diameter) and volumetry of the wheal using digital volumetric measurements 15 and 30 minutes after provocation. Flare will be measured in extent by measuring flare diameter (mean of the largest diameter and the perpendicular diameter) and in intensity using a mexameter 15 and 30 minutes after provocation.
- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by histamine as described above",U1111-1134-0703,2012-09-03,yes,Pruritus,"Arm 1 topical 3% polidocanol solution, one time application to the skin as spray, about 1ml in total; histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds; Arm 2 placebo, one time application to the skin as spray, about 1ml in total; histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds",Interventional,Randomized controlled trial,Blinded,Placebo,Crossover,N/A,To assess the effect of 3% Polidocanol on pruritus induced by Mucuna pruriens (cowhage) by itch intensity (VAS) within 30 minutes after Mucuna application,"- To assess the effect of 3% Polidocanol on pruritus induced by histamine (by VAS for 30 minutes)
- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by Mucuna pruriens (cowhage). Wheal development will be assessed by measuring wheal diameter (mean of the largest diameter and the perpendicular diameter) and volumetry of the wheal using digital volumetric measurements 15 and 30 minutes after provocation. Flare will be measured in extent by measuring flare diameter (mean of the largest diameter and the perpendicular diameter) and in intensity using a mexameter 15 and 30 minutes after provocation.
- To assess the effect of 3% Polidocanol on wheal development, flare development, and change in blood flow induced by histamine as described above
",Germany,University Medical Center Berlin,2012-09-03,Actual,40,2012-11-17,Healthy individuals,"Pregnancy, breast feeding, skin diseases, diseases of the peripheral nervous system, intake of antihistamines, NSAIDs, local anesthetics or mast cell stabilizers within 5 days prior to testing, intake of antideppressants within 14 days prior to testing, intake of steroids (topical or systemic) within 7 days prior to testing.","Randomized, placebo-controlled, double-blind trial to study the effects of polidocanol on experimental pruritus","Recruiting complete, follow-up complete",Klinik für Dermatologie und Allergologie
Charité - Universitätsmedizin Berlin; Klinik für Dermatologie und Allergologie
Charité - Universitätsmedizin Berlin; Klinik für Dermatologie und Allergologie
Charité - Universitätsmedizin Berlin,martin.metz@charite.de; martin.metz@charite.de; hesna.goezluekaya@charite.de,"Arm 1 topical 3% polidocanol solution, one time application to the skin as spray, about 1ml in total; histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds; Arm 2 placebo, one time application to the skin as spray, about 1ml in total; histamine prick (10mg/ml), 40 cowhage spicules rubbed on the skin for 40 seconds",2012-09-03,NA,2012-09-03,40,Interventional,TRUE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2012,NA,FALSE,TRUE,FALSE
23381,NA,DRKS00010878,DRKS00010878,NCT: NA ICTRP: 2016-08-08 DRKS: 2016-08-08,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure (how are differences calculated?)",NA,NA,NA,NCT: NA ICTRP: 30 DRKS: Tatsächlich 30,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,D467/16,Speech intelligibility in CI patients using NR3 and SpatialNR,Speech intelligibility in CI patients using NR3 and SpatialNR - Noise cancalation methods in CI patients ,audio@uksh.de,audio@uksh.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Treatment;,N/A,2016-08-08,2016-08-17,30,Complete: follow-up complete,Universitätsklinikum Schleswig-Holstein Campus Kiel,NULL,germany,Intervention 1: Study participants receive successively the possibility to use current noise suppression NR2 and compare this to NR3 SpatialNR. There is no comparison with other Groups of noise Suppression algorithms.
An intra-individual comparison will be performed.,"Inclusion criteria: Postlingual onset of profound sensorineural hearing loss , no congenital hearing loss ; Hearing loss in opposite ear least PTA = 50 dB
• Freedom or CI500 series implant (Cochlear)
• use the speech processor CP910 with a minimum of 6 months experience
• speech understanding in quiet ( Freiburger words at 70 dB SPL ) in the implanted ear of at least 50 % and understanding in Oldenburg sentence test in quiet at 70 dB at least 80%
• Preferably unilateral CI patients ; in bilateral CI patients fitting should be bilateral.
• language skills : German mother tongue",Exclusion criteria: Unrealistic expectations
• limitations that are inherent in clinical study
• Unwillingness or inability of / the candidate concerning the experimental requirements
• Additional disadvantages which would limit the participation in the audiological tests,Examination of differences in speech comprehension after 2-3 weeks adaptation(speech understanding in quiet by Freiburger words; speech understanding in noise by Oldenburger sentences),subjective rating together with speech intelligibility (using questionnaire HisQui19),,2016-08-08,yes,cochlear implant; Presence of otological and audiological implants,Arm 1 Study participants receive successively the possibility to use current noise suppression NR2 and compare this to NR3 SpatialNR. There is no comparison with other Groups of noise Suppression algorithms.
An intra-individual comparison will be performed.,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,Examination of differences in speech comprehension after 2-3 weeks adaptation(speech understanding in quiet by Freiburger words; speech understanding in noise by Oldenburger sentences),subjective rating together with speech intelligibility (using questionnaire HisQui19),Germany,Medical Center Kiel,2016-08-17,Actual,30,2017-08-04,"Postlingual onset of profound sensorineural hearing loss , no congenital hearing loss ; Hearing loss in opposite ear least PTA ≥ 50 dB
• Freedom or CI500 series implant (Cochlear)
• use the speech processor CP910 with a minimum of 6 months experience
• speech understanding in quiet ( Freiburger words at 70 dB SPL ) in the implanted ear of at least 50 % and understanding in Oldenburg sentence test in quiet at 70 dB at least 80%
• Preferably unilateral CI patients ; in bilateral CI patients fitting should be bilateral.
• language skills : German mother tongue", Unrealistic expectations
• limitations that are inherent in clinical study
• Unwillingness or inability of / the candidate concerning the experimental requirements
• Additional disadvantages which would limit the participation in the audiological tests,Speech intelligibility in CI patients using NR3 and SpatialNR,"Recruiting complete, follow-up complete",Universitätsklinikum Schleswig-Holstein Campus Kiel; Universitätsklinikum Schleswig-Holstein Campus Kiel; Universitätsklinikum Schleswig-Holstein Campus Kiel,[---]*; audio@uksh.de; audio@uksh.de,Arm 1 Study participants receive successively the possibility to use current noise suppression NR2 and compare this to NR3 SpatialNR. There is no comparison with other Groups of noise Suppression algorithms.
An intra-individual comparison will be performed.,2016-08-17,NA,2016-08-08,30,Observational,FALSE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,2016,NA,FALSE,TRUE,FALSE
35929,NA,DRKS00005792,NA,NCT: NA ICTRP: NA DRKS: 2014-05-06,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: NA DRKS: Tatsächlich 600,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,Studienprotokoll,https://doi.org/10.1111/ijs.12527,NA,2014-05-12,NA,2014-03-31,2017-02-01,Interventional,Thrombectomy in Patients Ineligible for iv tPA,Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment,Terminated,N/A,4,Actual,University Hospital Heidelberg,mRS Shift,Neurological outcome;Health Status;Infarct volume;Successful Recanalization,DRKS00005792;UH-Heidelberg-THRILL,Thrombectomy in Patients Ineligible for iv tPA,Comparison of Thrombectomy and Standard Care for Ischemic Stroke in Patients Ineligibility for Tissue Plasminogen Activator Treatment,,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). ,N/A,2014-04-30,2014-03-20,4,Terminated,University Hospital Heidelberg,"University Hospital, Aachen;University Hospital Augsburg;Vivantes Krankenhaus Berlin Neukölln;Ruhr University of Bochum;Klinikum Dortmund Wirbelsäulenchirurgie;University of Erlangen-Nürnberg Medical School;Alfried Krupp Krankenhaus;University Hospital, Essen;University Hospital Freiburg;University Medical Center Goettingen;Universitätsklinikum Hamburg-Eppendorf;Universitätsklinik für Neurologie, Innsbruck;Universitätsklinikum Köln;The Wagner-Jauregg Provincial Neuropsychiatric Clinic;Klinikum der Universitaet Muenchen;Klinikum rechst der Isar Technische Universitaet Muenchen;KLINIKUM VEST Recklinghausen;Wuerzburg University Hospital;Asklepios Kliniken Hamburg GmbH",austria;germany;austria;germany,Device: Thrombectomy;Other: Best medical care,"
Inclusion Criteria:
- Patient is ineligible for treatment with IV tPA according to licensing criteria (e.g.
anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).
- Randomization within 7 hours after stroke onset.
- Endovascular treatment is expected to be finished within 8 hours after symptom onset
by judgment of the interventional Neuroradiologist in charge.
- Patient must demonstrate clinical signs and symptoms attributable to target area of
occlusion consistent with the diagnosis of ischemic stroke, including impairment of
the following: language, motor function, sensation, cognition, gaze, and/or vision for
at least 30 minutes without relevant improvement.
- Female and male patient between 18-80 years of age
- NIHSS Score of >7 and <25
- Patient signed informed consent (IC) form by patient, legal representative, or by an
independent physician who is familiar with this types of illness if the other options
are not possible.
- A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the
thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or
the intracranial segment of the distal internal carotid artery (ICA).
- Prior to new focal neurological deficit, mRS score was =1.
Exclusion Criteria:
- Patient is eligible for and receives IV tPA according to licensing criteria
- Patient with an international normalized ratio (INR) of >3
- Patient is an active participant in another drug or device treatment trial for any
disease state, or patient is expected to start participation in another drug or device
treatment trial while enrolled in this protocol, unless approved by Sponsor.
- Patient has pre-existing neurological or psychiatric disease that could impede the
study results or would confound the neurological or functional evaluations.
- Patient has carotid dissection, high grade stenosis = 70% proximal to occlusion that
requires stenting, or excessive tortuosity to gain access to occlusion, as determined
by MRA/ CTA of neck and head.
- Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection
or aneurysm, no arterial transfemoral access)
- Patient has history of contraindication for contrast medium.
- Patient is known to have infective endocarditis
- CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on
unenhanced CT and cerebral blood volume (CBV) drop on CBV maps on Computed Tomography
Perfusion (CTP), or, alternatively as per institutional standard, restricted diffusion
on Diffusion weighted imaging (DWI) with an Alberta Stroke Program Early CT score
(ASPECTs) of 6 or less
- Female of childbearing potential who is known to be pregnant and/or lactating or who
has a positive pregnancy test on admission.
- Patients anticipated life expectancy is less than 6 Months.
",NULL,mRS Shift,Neurological outcome;Health Status;Infarct volume;Successful Recanalization,,2014-05-06,yes,Cerebral infarction,Arm 1 best medical care; Arm 2 endovascular thrombectomy using a stent-retriever and best medical care,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,N/A,Degree of disability after stroke assessed by modified Rankin Scale (mRS) outcome at 90 days poststroke,Good neurological outcome with 90-day mRS≤2 or 90-day NIHSS score improvement ≥10 from baseline
Excellent neurological outcomes with 90-day mRS≤1
Infarct volume at 30 (-/+ 6) hours (CT or MRI).
Difference of infarct volume from infarct volume as predicted by pretreatment imaging
Functional health status and quality of life 90 (±14) days after stroke (EQ-5D)
For the endovascular treatment group successful recanalization will be defined as TICI 2b or 3.,Germany; Austria,University Medical Center Aachen; Medical Center Bochum; Medical Center Berlin; University Medical Center Dortmund; University Medical Center Erlangen; University Medical Center Essen; Medical Center Essen; University Medical Center Freiburg im Breisgau; University Medical Center Göttingen; Medical Center Hamburg; University Medical Center Hamburg; University Medical Center Heidelberg; University Medical Center Köln; Medical Center Linz; University Medical Center München; University Medical Center München; Medical Center Recklinghausen; University Medical Center Würzburg; Medical Center Augsburg,2014-04-20,Actual,600,2015-05-05,"Moderate to severe stroke (NIHSS>7 and <26)
Ineligibility for iv tPA and no prior iv tPA therapy
Premorbid mRS 0-1
Life expectancy > 6 Months
Treatment can be accomplished within 8 hours after stroke onset
Informed consent by the patient, legal guardian, or independent physician
Imaging criteria:
Occlusion of the M1 segment of the middle cerebral artery (MCA), and/or the intracranial segment of the distal internal carotid artery (ICA), determined by MRA or CTA
CT and CBV map on CTP or DWI with an ASPECT score of 7-10","Patient is eligible for and receives IV tPA according to licensing criteria
Patient with an INR of >3
Patient is an active participant in another drug or device treatment trial for any disease state,
or patient is expected to start participation in another drug or device treatment trial while
enrolled in this protocol, unless approved by Sponsor.
Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
Patient has history of contraindication for contrast medium.
Patient is known to have infective endocarditis
CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on
unenhanced CT and CBV drop on CBV maps on CTP, or, alternatively as per institutional
standard, restricted diffusion on DWI with an ASPECT score of 6 or less
Female of childbearing potential who is known to be pregnant and/or lactating or who has a
positive pregnancy test on admission.
Patients anticipated life expectancy is less than 6 Months.",Thrombectomy in patients ineligible for iv tPA,Recruiting stopped after recruiting started ,UniversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie; UniversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie; UniversitätsKlinikum HeidelbergNeurologische KlinikAbteilung Neuroradiologie,thrill@med.uni-heidelberg.de; thrill@med.uni-heidelberg.de; thrill@med.uni-heidelberg.de,Arm 1 best medical care; Arm 2 endovascular thrombectomy using a stent-retriever and best medical care,2014-03-31,2014-04-30,2014-04-30,4,Interventional,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2014,NA,TRUE,TRUE,FALSE
21052,NA,DRKS00015296,DRKS00015296,NCT: NA ICTRP: 2018-08-20 DRKS: 2018-08-20,1,NA,NA,1,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 30 DRKS: Geplant 30,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,319/17,"Expiratory flow limitation via 'Flow-Limiter': A feasability study wth spontaneously breathing, lung healthy volunteers","Expiratory flow limitation via 'Flow-Limiter': A feasability study wth spontaneously breathing, lung healthy volunteers - Flow Limiter with volunteers ",johannes.schmidt@uniklinik-freiburg.de,johannes.schmidt@uniklinik-freiburg.de,Interventional,Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject). Control: Other. Assignment: Crossover. Study design purpose: Basic research/physiological study;,N/A,2018-08-20,2018-08-27,30,Pending,Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg,NULL,germany,"Intervention 1: Cross over design. After baseline measurement of the expiratory flow, the flow will be limited in two steps (ca. 30% and ca. 60%; 3 min. each; randomised sequence). Intervention 2: see Arm 1",Inclusion criteria: lung healthy,"Exclusion criteria: known cardiocirculatory diseases, known lung diseases, pregnancy, active implants","Tolerable expiratory flow limitation, rated by the volunteer directly after the experiment.","Expiratory peak flow, measured by pneumotachography as mean for the duration of the experiment. Regional ventilation, measured by electrical impedance tomography as a mean for the duration of the experiment. Subjective perception, rated by the volunteer as forced choice (better/worse), directly after the experiment.",,2018-08-20,yes,Modulation of the expiration during spontanous breathing comparable to pursed lip breathing; lung healthy volunteers,"Arm 1 Cross over design. After baseline measurement of the expiratory flow, the flow will be limited in two steps (ca. 30% and ca. 60%; 3 min. each; randomised sequence). ; Arm 2 see Arm 1",Interventional,Randomized controlled trial,Blinded,Other,Crossover,N/A,"Tolerable expiratory flow limitation, rated by the volunteer directly after the experiment. ","Expiratory peak flow, measured by pneumotachography as mean for the duration of the experiment. Regional ventilation, measured by electrical impedance tomography as a mean for the duration of the experiment. Subjective perception, rated by the volunteer as forced choice (better/worse), directly after the experiment.",Germany,University Medical Center Freiburg im Breisgau,2018-08-27,Planned,30,NA,lung healthy,"known cardiocirculatory diseases, known lung diseases, pregnancy, active implants","Expiratory flow limitation via 'Flow-Limiter': A feasability study wth spontaneously breathing, lung healthy volunteers",Recruiting planned,Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg; Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg; Klinik für Anästhesiologie und Intensivmedizin Universitätsklinikum Freiburg,johannes.schmidt@uniklinik-freiburg.de; johannes.schmidt@uniklinik-freiburg.de; johannes.schmidt@uniklinik-freiburg.de,"Arm 1 Cross over design. After baseline measurement of the expiratory flow, the flow will be limited in two steps (ca. 30% and ca. 60%; 3 min. each; randomised sequence). ; Arm 2 see Arm 1",2018-08-27,NA,2018-08-20,30,Interventional,FALSE,TRUE,NA,TRUE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,2018,NA,FALSE,TRUE,FALSE
24463,NA,DRKS00009264,DRKS00009264,NCT: NA ICTRP: 2015-09-01 DRKS: 2015-09-01,1,1,NA,1,1,NA,NA,NA,NA,NA,5,1,NA,3,1,"no AM, no measure (morbidity)",NCT: NA ICTRP: 141 DRKS: Tatsächlich 141,126,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1038/srep32286,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,558/14,Stereotactic biopsy vs. surgical resection in patient with diffuse low grade gliomas. Influence of inital management strategies on surival. A retrospective study.,Stereotactic biopsy vs. surgical resection in patient with diffuse low grade gliomas. Influence of inital management strategies on surival. A retrospective study. ,peter.reinacher@uniklinik-freiburg.de,peter.reinacher@uniklinik-freiburg.de,Observational,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Other;,N/A,2015-09-01,2015-02-01,141,Complete: follow-up complete,Universitätsklinikum Freiburg,NULL,germany,Intervention 1: Assessment of Overall Survival (OS) of all adult patients with a first histological diagnosis of diffuse low grade gliomas (DLGG) who were treated by either stereotactic biopsy or resection at the University Medical Center Freiburg between 2004 and 2012.,Inclusion criteria: All patients 18 years or older with a first histological diagnosis of a supratentorial DLGG (WHO°II) from either a stereotactic biopsy or a neurosurgical resection between 2004 and 2012 in the Department of Neurosurgery or the Department of Stereotactic and Functional Neurosurgery of the University Medical Center Freiburg.,Exclusion criteria: Patients with evidence for a gemistocytic histology.,"Overall survival (OS) from the date of the first histological diagnosis until death or November 30, 2014 or lost to follow-up, whatever is earlier.",Operative morbidity and mortality,,2015-09-01,yes,Benign neoplasm of brain and other parts of central nervous system; Malignant neoplasm of brain,Arm 1 Assessment of Overall Survival (OS) of all adult patients with a first histological diagnosis of diffuse low grade gliomas (DLGG) who were treated by either stereotactic biopsy or resection at the University Medical Center Freiburg between 2004 and 2012.,Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Overall survival (OS) from the date of the first histological diagnosis until death or November 30, 2014 or lost to follow-up, whatever is earlier.",Operative morbidity and mortality,Germany,University Medical Center Freiburg im Breisgau,2015-02-01,Actual,141,2015-03-31,All patients 18 years or older with a first histological diagnosis of a supratentorial DLGG (WHO°II) from either a stereotactic biopsy or a neurosurgical resection between 2004 and 2012 in the Department of Neurosurgery or the Department of Stereotactic and Functional Neurosurgery of the University Medical Center Freiburg.,Patients with evidence for a gemistocytic histology.,Stereotactic biopsy vs. surgical resection in patient with diffuse low grade gliomas. Influence of inital management strategies on surival. A retrospective study.,"Recruiting complete, follow-up complete",Universitätsklinikum Freiburg; Universitätsklinikum Freiburg - Abteilung Stereotaktische und Funktionelle Neurochirurgie; Universitätsklinikum Freiburg,[---]*; peter.reinacher@uniklinik-freiburg.de; peter.reinacher@uniklinik-freiburg.de,Arm 1 Assessment of Overall Survival (OS) of all adult patients with a first histological diagnosis of diffuse low grade gliomas (DLGG) who were treated by either stereotactic biopsy or resection at the University Medical Center Freiburg between 2004 and 2012.,2015-02-01,NA,2015-09-01,141,Observational,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2015,NA,FALSE,TRUE,FALSE
21245,NA,DRKS00014636,DRKS00014636,NCT: NA ICTRP: 2018-06-22 DRKS: 2018-06-22,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no metric",2,NA,"no AM, no metric, no measure",NCT: NA ICTRP: 180 DRKS: Tatsächlich 180,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,262/17,"Stress, Trauma, And Recovery: an obsesrvational case-control-study to examine the association between cognition, lifetime stressors and biomarkers of Alzheimer´s disease","Stress, Trauma, And Recovery: an obsesrvational case-control-study to examine the association between cognition, lifetime stressors and biomarkers of Alzheimer´s disease - STAR ",christine.arnim@uni-ulm.de,hellen.apel@uni-ulm.de,Observational,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Other. Assignment: Parallel. Study design purpose: Prevention;,N/A,2018-06-22,2018-01-05,180,Recruiting,Universitätsklinikum UlmNeurologie,NULL,germany,"Intervention 1: The lifetime stress burden should be studied in individuals with subjective cognitive impairment, mild cognitive impairment, and mild to moderate Alzheimer's dementia. The study will cover various types of stress across lifespan, including occupational stress (Fragebogen zu Intensität und Tätigkeitsspielraum, FIT), stress-associated personality traits (EPQR-K, neuroticism), incriminating life events (Life Events Checklist (LEC), as well as neglect and abuse experiences childhood (Childhood Trauma Questionnaire; CTQ). Cognition at the time of completing the questionnaires is recorded using the Clinical Dementia Rating Scale (CDR), Shulman´s clock drawing test and Consortium to Establish a Registry for Alzheimer's Disease (CERAD). In addition, routine clinical data such as CSF-derived dementia markers are also used in the study. Furthermore, mental, social and physical activities carried out over the lifespan are recorded and their connection to cognition are analyzed Intervention 2: The relatives of the participants are recruited as a cognitively healthy control group. The control group completes the same questionnaires as the patient group. To rule out cognitive deficits, participants are asked if they have noticed subjective cognitive deficits and the Shulman's clock drawing test is completed. In addition, medical conditions that could influence cognition are requested.","Inclusion criteria: Degree of dementia: CDR memory value 9; subjective cognitive impairment, MCI, mild to moderate Alzheimer's disease (ICD
10, NINCDS/ ADRDA criteria)","Exclusion criteria: CDR memory value = 2 or MMSE = 9; severe Alzheimer's disease, frontotemporal dementia, levy body dementia, dementia in Parkinson's disease, other rare forms of dementia (corticobasal degeneration, Korsakoff's disease, Creutzfeldt-Jakob disease, PCA), severe psychiatric illness or previous illness (drug or alcohol abuse / - looking for the last 5 years, acute suicidality), brain tumor, cerebral hemorrhage, stroke, traumatic brain injury, acute inflammatory diseases of the CNS, hydrocephalus","The study will cover various types of stress across lifespan, including occupational stress (Fragebogen zu Intensität und Tätigkeitsspielraum, FIT), stress-associated personality traits (EPQR-K, neuroticism), incriminating life events (Life Events Checklist (LEC), as well as neglect and abuse experiences childhood (Childhood Trauma Questionnaire; CTQ). Cognition at the time of completing the questionnaires is recorded using the Clinical Dementia Rating Scale (CDR), Shulman´s clock drawing test and Consortium to Establish a Registry for Alzheimer's Disease (CERAD). In addition, routine clinical data such as CSF-derived dementia markers are also used in the study.","Furthermore, mental, social and physical activities carried out over the lifespan are recorded and their connection to cognition analyzed",,2018-06-22,yes,Dementia in Alzheimer disease; Mild cognitive disorder,"Arm 1 The lifetime stress burden should be studied in individuals with subjective cognitive impairment, mild cognitive impairment, and mild to moderate Alzheimer's dementia. The study will cover various types of stress across lifespan, including occupational stress (Fragebogen zu Intensität und Tätigkeitsspielraum, FIT), stress-associated personality traits (EPQR-K, neuroticism), incriminating life events (Life Events Checklist (LEC), as well as neglect and abuse experiences childhood (Childhood Trauma Questionnaire; CTQ). Cognition at the time of completing the questionnaires is recorded using the Clinical Dementia Rating Scale (CDR), Shulman´s clock drawing test and Consortium to Establish a Registry for Alzheimer's Disease (CERAD). In addition, routine clinical data such as CSF-derived dementia markers are also used in the study. Furthermore, mental, social and physical activities carried out over the lifespan are recorded and their connection to cognition are analyzed; Arm 2 The relatives of the participants are recruited as a cognitively healthy control group. The control group completes the same questionnaires as the patient group. To rule out cognitive deficits, participants are asked if they have noticed subjective cognitive deficits and the Shulman's clock drawing test is completed. In addition, medical conditions that could influence cognition are requested.",Non-interventional,Non-randomized controlled trial,Open (masking not used),Other,Parallel,N/A,"The study will cover various types of stress across lifespan, including occupational stress (Fragebogen zu Intensität und Tätigkeitsspielraum, FIT), stress-associated personality traits (EPQR-K, neuroticism), incriminating life events (Life Events Checklist (LEC), as well as neglect and abuse experiences childhood (Childhood Trauma Questionnaire; CTQ). Cognition at the time of completing the questionnaires is recorded using the Clinical Dementia Rating Scale (CDR), Shulman´s clock drawing test and Consortium to Establish a Registry for Alzheimer's Disease (CERAD). In addition, routine clinical data such as CSF-derived dementia markers are also used in the study.","Furthermore, mental, social and physical activities carried out over the lifespan are recorded and their connection to cognition analyzed",Germany,University Medical Center Ulm,2018-01-05,Actual,180,NA,"Degree of dementia: CDR memory value <2 or MMSE> 9; subjective cognitive impairment, MCI, mild to moderate Alzheimer's disease (ICD
10, NINCDS/ ADRDA criteria)","CDR memory value ≥ 2 or MMSE ≤ 9; severe Alzheimer's disease, frontotemporal dementia, levy body dementia, dementia in Parkinson's disease, other rare forms of dementia (corticobasal degeneration, Korsakoff's disease, Creutzfeldt-Jakob disease, PCA), severe psychiatric illness or previous illness (drug or alcohol abuse / - looking for the last 5 years, acute suicidality), brain tumor, cerebral hemorrhage, stroke, traumatic brain injury, acute inflammatory diseases of the CNS, hydrocephalus","Stress, Trauma, And Recovery: an obsesrvational case-control-study to examine the association between cognition, lifetime stressors and biomarkers of Alzheimer´s disease",Recruiting ongoing,Universitätsklinikum UlmNeurologie; Universitätsklinikum Ulm Neurologie; Universitätsklinikum Ulm Neurologie,[---]*; christine.arnim@uni-ulm.de; hellen.apel@uni-ulm.de,"Arm 1 The lifetime stress burden should be studied in individuals with subjective cognitive impairment, mild cognitive impairment, and mild to moderate Alzheimer's dementia. The study will cover various types of stress across lifespan, including occupational stress (Fragebogen zu Intensität und Tätigkeitsspielraum, FIT), stress-associated personality traits (EPQR-K, neuroticism), incriminating life events (Life Events Checklist (LEC), as well as neglect and abuse experiences childhood (Childhood Trauma Questionnaire; CTQ). Cognition at the time of completing the questionnaires is recorded using the Clinical Dementia Rating Scale (CDR), Shulman´s clock drawing test and Consortium to Establish a Registry for Alzheimer's Disease (CERAD). In addition, routine clinical data such as CSF-derived dementia markers are also used in the study. Furthermore, mental, social and physical activities carried out over the lifespan are recorded and their connection to cognition are analyzed; Arm 2 The relatives of the participants are recruited as a cognitively healthy control group. The control group completes the same questionnaires as the patient group. To rule out cognitive deficits, participants are asked if they have noticed subjective cognitive deficits and the Shulman's clock drawing test is completed. In addition, medical conditions that could influence cognition are requested.",2018-01-05,NA,2018-06-22,180,Observational,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2018,NA,FALSE,TRUE,FALSE
22369,NA,DRKS00012757,DRKS00012757,NCT: NA ICTRP: 2017-07-18 DRKS: 2017-07-18,1,NA,NA,2,NA,NA,NA,NA,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 280 DRKS: Tatsächlich 280,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-02-05,NA,2017-07-18,2018-10-01,Observational,Diagnostic Agreement of iFR and QFR.,DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.,Unknown status,NA,250,Anticipated,Contilia Clinical Research Institute,Diagnostic performance of QFR in comparison to iFR;QFR- iFR diagnostic grey zone calculation.,Diagnostic performance of QFR in comparison to FFR;QFR- FFR diagnostic grey zone calculation.;Diagnostic performance of iFR in comparison to FFR;iFR- FFR diagnostic grey zone calculation.;effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.;Effect of lesion location on QFR-iFR-FFR disagreement.;Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.,U1111-1199-4364,Diagnostic Agreement of iFR and QFR.,DETErmining the funCTional Significance of Intermediate Stenoses in isCHEMIc heArt Disease (DETECT ISCHEMIA): Diagnostic Agreement of iFR and QFR.,;c.jensen@contilia.de;c.jensen@contilia.de,;c.jensen@contilia.de;c.jensen@contilia.de,Observational,,,2018-01-27,2017-07-18,250,Unknown status,Contilia Clinical Research Institute,NULL,germany,Diagnostic Test: QFR and iFR,"
Inclusion Criteria:
- Age > 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest
pain, abnormal stress testing, abnormal noninvasive testing)
- Patients witch semi recent (>3 days) acute coronary syndromes can be included but only
for the non-culprit vessels and outside of primary intervention during acute
myocardial infarction.
- Willing to participate and able to understand, read and sign the informed consent
document before the planned procedure
- Eligible for coronary angiography and/or percutaneous coronary intervention
- Coronary artery disease with at least 1 or more visually assessed de novo coronary
stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches
by coronary angiogram.
Exclusion criteria:
- Contraindication to adenosine administration
- Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
",NULL,Diagnostic performance of QFR in comparison to iFR;QFR- iFR diagnostic grey zone calculation.,Diagnostic performance of QFR in comparison to FFR;QFR- FFR diagnostic grey zone calculation.;Diagnostic performance of iFR in comparison to FFR;iFR- FFR diagnostic grey zone calculation.;effect of 3D QCA characteristics on QFR-iFR-FFR disagreement.;Effect of lesion location on QFR-iFR-FFR disagreement.;Effect of p20-DAC2 score in proximal and mid-LAD stenosis on QFR-iFR-FFR disagreement.,U1111-1199-4364,2017-07-18,yes,"Chronic ischaemic heart disease, unspecified","Arm 1 Detect Ischemia is an single center, prospective observational study. All patients with clinical indication for invasive coronary angiography and intermediate coronary artery stenosis will be evaluated by fractional flow reserve (FFR), instantaneous wave-free ratio and quantitative flow Ratio measuerments. ",Non-interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,Sensitivity and specificity of quantitative flow Ratio (QFR) according to instantaneous wave-free Ratio (iFR): Proportion of patients with positive/negative QFR and positive/negative iFR resp. (true positives/negatives)
Diagnostic performance of QFR in comparison to iFR reported as positive and negative likelihood ratio
Diagnostic grey zone calculation. QFR limits for achieving 95% sensitivity and specificity in comparison to iFR
,"Comparison of quantitative flow Ratio (QFR) and instantaneous wave-free Ratio (iFR) with fractional flow Ratio (FFR)
- Sensitivity and specificity of QFR according to FFR: Proportion of patients with positive/negative QFR and positive/negative FFR resp. (true positives/negatives)
- Diagnostic performance of QFR in comparison to FFR reported as positive and negative likelihood ratio
- Diagnostic grey zone calculation. QFR limits for achieving 95% sensitivity and specificity in comparison to FFR
- Sensitivity and specificity of iFR according to FFR: Proportion of patients with positive/negative iFR and positive/negative FFR resp. (true positives/negatives)
- Diagnostic performance of iFR in comparison to FFR reported as positive and negative likelihood ratio
- Diagnostic grey zone calculation. iFR limits for achieving 95% sensitivity and specificity in comparison to FFR
• Cost analysis
- Cost savings of removing secondary investigations by using QFR
- Cost savings of removing the need for Adenosine by using iFR.
- Evaluation of costs by excess/reduced need for stenting when iFR and FFR disagree
• Lesion characteristics
- Influence of 3D QCA characteristics (minimum luminal area (MLA), percentage area stenosis, lesion length, minimum luminal diameter (MLD) and percentage diameter stenosis) in the prediction of iFR -FFR disagreement.
- Influence of lesion location in the prediction of iFR -FFR disagreement.
- Influence of p20-DAC2 score in proximal and mid-LAD stenosis in the prediction of iFR -FFR disagreement.
",Germany,Medical Center Essen,2017-07-24,Actual,280,NA,"•Age > 18 and < 90 years of age with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
•Patients witch semi recent ( >3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
•Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
•Eligible for coronary angiography and/or percutaneous coronary intervention
•Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.
",• Contraindication to adenosine administration
• Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
,DETErmining the funCTional significance of Intermediate Stenoses in isCHEMIc heArt disease: Diagnostic agreement of iFR and QFR.,Recruiting ongoing,Elisabeth Krankenhaus EssenKlinik für Kardiologie und Angiologie; Elisabeth Krankenhaus EssenKlinik für Kardiologie und Angiologie; Elisabeth Krankenhaus EssenKlinik für Kardiologie und Angiologie,[---]*; c.jensen@contilia.de; c.jensen@contilia.de,"Arm 1 Detect Ischemia is an single center, prospective observational study. All patients with clinical indication for invasive coronary angiography and intermediate coronary artery stenosis will be evaluated by fractional flow reserve (FFR), instantaneous wave-free ratio and quantitative flow Ratio measuerments. ",2017-07-24,2018-01-27,2017-07-18,280,Observational,FALSE,TRUE,FALSE,TRUE,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,2017,NA,TRUE,TRUE,FALSE
25636,NA,DRKS00006293,DRKS00006293,NCT: NA ICTRP: 2014-07-03 DRKS: 2014-07-03,1,NA,NA,1,NA,NA,NA,1,NA,NA,5,NA,NA,4,NA,no AM,NCT: NA ICTRP: 52 DRKS: Tatsächlich 52,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,U1111-1158-9113;2014-148-f-S,Comparison of wound treatment and wound healing with a hyaluronic acid-containing matrix vs. hydrofibre and skin transplant healing rates for defect coverage after resection of skin tumors,Comparison of wound treatment and wound healing with a hyaluronic acid-containing matrix vs. hydrofibre and skin transplant healing rates for defect coverage after resection of skin tumors ,pl-chir@fachklinik-hornheide.de,pl-chir@fachklinik-hornheide.de,Interventional,Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Treatment;,N/A,2014-07-03,2014-07-14,52,Other,"ATG-Med, AT Technologies GmbH",NULL,germany,Intervention 1: After tumor excision wound treatment with Hyalomatrix (Anika Therapeutics S.r.l) followed by autologous skin graft Intervention 2: After tumor excision open wound treatment with Aqaucel (Convatec) followed by autologous skin graft,Inclusion criteria: Skin Tumor in need of excision and skin transplantation,"Exclusion criteria: Persons aged under 18, Wound infection before surgery, missing informed consent","Skin transplant take rate 1 week after grafting, as well as after 6-12 months. Scar evaluation with POSAS scar scale and high resolution skin ultrasound examination",Pain during wound dressing after tumor excision with visual analog pain scale (VAS)
scar quaulity (POSAS scar scale) 6-12 months after skin grafting,U1111-1158-9113,2014-07-03,no,Malignant melanoma of skin; Other malignant neoplasms of skin,Arm 1 After tumor excision wound treatment with Hyalomatrix (Anika Therapeutics S.r.l) followed by autologous skin graft; Arm 2 After tumor excision open wound treatment with Aqaucel (Convatec) followed by autologous skin graft,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,N/A,"Skin transplant take rate 1 week after grafting, as well as after 6-12 months. Scar evaluation with POSAS scar scale and high resolution skin ultrasound examination",Pain during wound dressing after tumor excision with visual analog pain scale (VAS)
scar quaulity (POSAS scar scale) 6-12 months after skin grafting,Germany,Medical Center Münster,2014-07-14,Actual,52,2016-04-30,Skin Tumor in need of excision and skin transplantation,"Persons aged under 18, Wound infection before surgery, missing informed consent",Comparison of wound treatment and wound healing with a hyaluronic acid-containing matrix vs. hydrofibre and skin transplant healing rates for defect coverage after resection of skin tumors,Recruiting stopped after recruiting started ,"ATG-Med, AT Technologies GmbH; Fachklinik HornheideAbteilung für Plastische und Ästhetische Chirurgie, Handchirurgie; Fachklinik HornheideAbteilung für Plastische und Ästhetische Chirurgie, Handchirurgie",tolga.halici@atg.eu.com; pl-chir@fachklinik-hornheide.de; pl-chir@fachklinik-hornheide.de,Arm 1 After tumor excision wound treatment with Hyalomatrix (Anika Therapeutics S.r.l) followed by autologous skin graft; Arm 2 After tumor excision open wound treatment with Aqaucel (Convatec) followed by autologous skin graft,2014-07-14,NA,2014-07-03,52,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2014,NA,FALSE,TRUE,FALSE
23781,NA,DRKS00010269,DRKS00010269,NCT: NA ICTRP: 2016-04-06 DRKS: 2016-04-06,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 108 DRKS: Tatsächlich 108,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,Studienprotokoll,https://doi.org/10.1186/s13063-016-1687-4,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,EK-BR 104/15-1,Fitnesstraining in patientes with intenisve care unit acquired muscle weakness: a randomized controlled trail,Fitnesstraining in patientes with intenisve care unit acquired muscle weakness: a randomized controlled trail - FITon ICU ,jan.mehrholz@klinik-bavaria.de,simone.thomas@klinik-bavaria.de,Interventional,"Allocation: Randomized controlled trial;. Masking: Blinded (assessor, data analyst). Control: Active control (effective treament of control group). Assignment: Parallel. Study design purpose: Treatment;",II,2016-04-06,2016-04-15,108,Recruiting,Klinik Bavaria Kreischa,NULL,germany,"Intervention 1: mobility program: monitored balancetraining in sitting and standing, walking on spot or in patients room, training sit to stand for a maximum of 30 min, 3-5 times/week, 2 weeks additionally to standard therapy Intervention 2: endurance training with a bedside-ergometer for a maximum of 30 min., 3-5 times/week, 2 weeks additionally to standard therapy","Inclusion criteria: chronic critically ill;
ICUAW (MRC<48); diagnoses of CIP,CIM or both; RASS -1, 1, 0, 1; patiet can perform all tests, allowed to sit in bed, mechanic ventilation, confirmed interesst of patient or guardian","Exclusion criteria: other illness of lower extremity; other neurological or psychiatric desease; no independent walking or sit to stand before; cardiorespiratory instability at T0; need for vasopressive support, severe illness of lumbar, thoracic or cervical spine, severe open wounds (abdomial, legs, pelvis), PAD >2, amputations upper limb, transfer to an other rehabilitation or intensiv care unit in the first 3 Weeks after adission; palliative care; dialyses more than 3 times/week, BMI: >35kg/m2","time till achiving walking ability (FAC 3):
daily measurement before start of study therapy until discharge
mobility (FSS-ICU):
before start of study therapy, directly after last study therapy unit and 3 weeks after the last examination","strength (MRC, grip strength), fitness (PFIT-s), ADL (Barthel-Index) directly before study therapy, directly after last study therapy unit and 3 weeks after the last examination
time till achiving indipendent sit to stand from a normal chair: daily measurement before start of study therapy until discharge",,2016-04-06,yes,[generalization G72.8: Other specified myopathies]; [generalization G62.8: Other specified polyneuropathies]; Muscle weakness (intenisve care unit acquired) ,"Arm 1 mobility program: monitored balancetraining in sitting and standing, walking on spot or in patients room, training sit to stand for a maximum of 30 min, 3-5 times/week, 2 weeks additionally to standard therapy; Arm 2 endurance training with a bedside-ergometer for a maximum of 30 min., 3-5 times/week, 2 weeks additionally to standard therapy",Interventional,Randomized controlled trial,Blinded,Active control (effective treament of control group),Parallel,II,"time till achiving walking ability (FAC 3):
daily measurement before start of study therapy until discharge
mobility (FSS-ICU):
before start of study therapy, directly after last study therapy unit and 3 weeks after the last examination","strength (MRC, grip strength), fitness (PFIT-s), ADL (Barthel-Index) directly before study therapy, directly after last study therapy unit and 3 weeks after the last examination
time till achiving indipendent sit to stand from a normal chair: daily measurement before start of study therapy until discharge",Germany,Medical Center Kreischa,2016-04-15,Actual,108,NA,"chronic critically ill;
ICUAW (MRC<48); diagnoses of CIP,CIM or both; RASS -1, 1, 0, 1; patiet can perform all tests, allowed to sit in bed, mechanic ventilation, confirmed interesst of patient or guardian","other illness of lower extremity; other neurological or psychiatric desease; no independent walking or sit to stand before; cardiorespiratory instability at T0; need for vasopressive support, severe illness of lumbar, thoracic or cervical spine, severe open wounds (abdomial, legs, pelvis), PAD >2, amputations upper limb, transfer to an other rehabilitation or intensiv care unit in the first 3 Weeks after adission; palliative care; dialyses more than 3 times/week, BMI: >35kg/m2",Fitnesstraining in patientes with intenisve care unit acquired muscle weakness: a randomized controlled trail,Recruiting ongoing,Klinik Bavaria Kreischa; Erste Private Europäische Medizinische Akademie für Rehabilitation; Erste Private Europäische Medizinische Akademie für Rehabilitation,[---]*; jan.mehrholz@klinik-bavaria.de; simone.thomas@klinik-bavaria.de,"Arm 1 mobility program: monitored balancetraining in sitting and standing, walking on spot or in patients room, training sit to stand for a maximum of 30 min, 3-5 times/week, 2 weeks additionally to standard therapy; Arm 2 endurance training with a bedside-ergometer for a maximum of 30 min., 3-5 times/week, 2 weeks additionally to standard therapy",2016-04-15,NA,2016-04-06,108,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2016,NA,FALSE,TRUE,FALSE
24912,NA,DRKS00006375,DRKS00006375,NCT: NA ICTRP: 2015-04-09 DRKS: 2015-04-09,1,NA,NA,2,NA,NA,NA,NA,NA,NA,4,NA,no measure,4,NA,no measure (unclear if the CT parameters are pre-defined),NCT: NA ICTRP: 80 DRKS: [---]* 80,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2014-03-13,NA,2012-04-30,2018-07-31,Observational,Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma,Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma,Completed,NA,60,Actual,Ludwig-Maximilians - University of Munich,Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters,Correlation of CT perfusion parameters at baseline as well as their relative changes after start of antiangiogenic therapy with response status according to RECIST 1.1,CTP NK 2012,Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma,Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma,;;;,;;;,Observational,,,2013-11-28,2012-04-20,60,Completed,Ludwig-Maximilians - University of Munich,NULL,germany,Other: Perfusion-CT,"
Inclusion Criteria:
- patients with metastasized renal cell carcinoma treated at the Department of Urology
(University of Munich - Grosshadern Campus)
1. with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib
(Nexavar®) as first-line therapy
2. with Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as
second-line therapy after failed first-line therapy, who are off therapy for at
least 2 weeks
- no contraindications against contrast-enhanced CT
- obtained informed consent to participate in the study
Exclusion Criteria:
Patients who have:
- not given informed consent
- known iodine allergy
- high grade renal insuffiency (eGFR < 30ml/min) not on dialysis
- overt hyperthyreoidism
- singular metastases <1cm in diameter
- an increase of their baseline creatine levels of >20% between CT examinations
",NULL,Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters,Correlation of CT perfusion parameters at baseline as well as their relative changes after start of antiangiogenic therapy with response status according to RECIST 1.1,NCT02086734; CTP NK 2012,2015-04-09,yes,"Metastatic Renal Cancer; Malignant neoplasm of kidney, except renal pelvis",Arm 1 Other: Perfusion-CT,Non-interventional,NA,NA,NA,NA,N/A,- Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters; time frame: up to 3 years
,- Correlation of CT perfusion parameters at baseline as well as their relative changes after start of antiangiogenic therapy with response status according to RECIST 1.1; time frame: up to 3 years
,Germany,[---]* München,2012-01-31,NA,80,NA,"Patients with metastasized renal cell carcinoma treated at the Department of Urology
(University of Munich - Grosshadern Campus)
1) with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as
first-line therapy
2.) with Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as
second-line therapy after failed first-line therapy, who are off therapy for at least 2
weeks
and who have given informed consent to participate in the study
",Patients who have:
- not given informed consent
- known iodine allergy
- high grade renal insuffiency (eGFR < 30ml/min) not on dialysis
- overt hyperthyreoidism
- singular metastases <1cm in diameter
- an increase of their baseline creatine levels of >20% between CT examinations
,Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma,Recruiting ongoing,Ludwig-Maximilians - University of Munich; Urologische Klinik und Poliklinik der Universität München; [---]*,[---]*; [---]*; [---]*,Arm 1 Other: Perfusion-CT,2012-04-30,2013-11-28,2013-11-28,60,Observational,FALSE,TRUE,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,TRUE,2012,NA,TRUE,TRUE,FALSE
27477,NA,DRKS00003622,DRKS00003622,NCT: NA ICTRP: 2012-03-15 DRKS: 2012-03-15,0,NA,Seems to be a crossover instead of a single-arm design,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no time frame",3,NA,"no AM, no time frame",NCT: NA ICTRP: 96 DRKS: Tatsächlich 96,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,578/2011BO2,Health Risks of Indoor Cold Environment,Health Risks of Indoor Cold Environment - ICE ,ulrich.lindemann@rbk.de,ulrich.lindemann@rbk.de,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Basic research/physiological study;,N/A,2012-03-15,2012-09-18,96,Complete: follow-up complete,Robert-Bosch-Krankenhaus,NULL,germany,"Intervention 1: Assessment of physical performance (power, gait analysis, sit-to-stand transfer, grip strength, leg extension strength, balance) exposed to 15°C and 25°C in randomized order. Assessment of quality of life, cognition, depression, nutritional status, and thermal well-being by questionnaires. Assessment of physical activity by body-worn sensors and questionnaire. Assessment of muscle mass (thigh) by MRI. Blood samples (inflammatory markers) are taken at normal room temperature.",Inclusion criteria: self-reported weakness of the legs,"Exclusion criteria: (1) cognitive impairment indicating a possible dementia, (2) the presence of uncontrolled cardiac illness, (3) functional relevant disease (e.g. neurological and/or orthopedic), which significantly influences walking performance or leg extension, and (4) terminal illness","Primary endpoint is muscle power assessed by the Nottingham Power Rig at 15°C and 25°C and the correlation between the change of power, related to different environmental temperature, and muscle mass assessed by MRI.","Secondary endpoint are cognition, assessed by the Trail Making Test, walking performance in single-task and dual-task condition (counting backwards in steps of 3), assessed on a GAITRite mat,and the sit-to-stand performance, classified by the time needed, during exposure to 15°C and 25°C environment, each.",,2012-03-15,yes,healthy older women,"Arm 1 Assessment of physical performance (power, gait analysis, sit-to-stand transfer, grip strength, leg extension strength, balance) exposed to 15°C and 25°C in randomized order. Assessment of quality of life, cognition, depression, nutritional status, and thermal well-being by questionnaires. Assessment of physical activity by body-worn sensors and questionnaire. Assessment of muscle mass (thigh) by MRI. Blood samples (inflammatory markers) are taken at normal room temperature.",Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Primary endpoint is muscle power assessed by the Nottingham Power Rig at 15°C and 25°C and the correlation between the change of power, related to different environmental temperature, and muscle mass assessed by MRI.","Secondary endpoint are cognition, assessed by the Trail Making Test, walking performance in single-task and dual-task condition (counting backwards in steps of 3), assessed on a GAITRite mat,and the sit-to-stand performance, classified by the time needed, during exposure to 15°C and 25°C environment, each.",Germany,Medical Center Stuttgart,2012-09-18,Actual,96,2013-12-31,self-reported weakness of the legs,"(1) cognitive impairment indicating a possible dementia, (2) the presence of uncontrolled cardiac illness, (3) functional relevant disease (e.g. neurological and/or orthopedic), which significantly influences walking performance or leg extension, and (4) terminal illness",Health Risks of Indoor Cold Environment,"Recruiting complete, follow-up complete",Robert-Bosch-Krankenhaus; Robert-Bosch-Krankenhaus; Robert-Bosch-Krankenhaus,clemens.becker@rbk.de; ulrich.lindemann@rbk.de; ulrich.lindemann@rbk.de,"Arm 1 Assessment of physical performance (power, gait analysis, sit-to-stand transfer, grip strength, leg extension strength, balance) exposed to 15°C and 25°C in randomized order. Assessment of quality of life, cognition, depression, nutritional status, and thermal well-being by questionnaires. Assessment of physical activity by body-worn sensors and questionnaire. Assessment of muscle mass (thigh) by MRI. Blood samples (inflammatory markers) are taken at normal room temperature.",2012-09-18,NA,2012-03-15,96,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2012,NA,FALSE,TRUE,FALSE
25095,NA,DRKS00007737,DRKS00007737,NCT: NA ICTRP: 2015-02-11 DRKS: 2015-02-11,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,NA,NCT: NA ICTRP: 107 DRKS: [---]* 107,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2014-07-30,NA,2019-10-16,2023-12-31,Interventional,Pazopanib vs. Pazopanib Plus Gemcitabine,"Pazopanib vs. Pazopanib Plus Gemcitabine in Patients With Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble -",Recruiting,Phase 2,107,Anticipated,North Eastern German Society of Gynaecological Oncology,Progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder,Objective response rate (RECIST v1.1 criteria);Objective response rate (RECIST v1.1 criteria);Objective response rate (RECIST v1.1 criteria);Safety - side effects;Quality of life (EORTC QLQ-C30);Translational research program,2012-003810-15;NOGGO U1,Pazopanib vs. Pazopanib Plus Gemcitabine,"Pazopanib vs. Pazopanib Plus Gemcitabine in Patients With Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble -",;mustea@ukbonn.de,;mustea@ukbonn.de,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2014-05-05,2019-10-16,107,Recruiting,North Eastern German Society of Gynaecological Oncology,Novartis Pharmaceuticals;medac GmbH,germany,Drug: Pazopanib plus Gemcitabine;Drug: Pazopanib,"
Inclusion Criteria:
1. Subjects must provide informed consent prior to performance of study-specific
procedures or assessments, and must be willing to comply with treatment and follow-up.
Procedures conducted as part of the subject's routine clinical management (e.g., blood
count, imaging study) and obtained prior to signing of informed consent may be
utilized for screening or baseline purposes provided these procedures are conducted as
specified in the protocol
2. Histologically or cytological confirmed uterine leiomyosarcoma or uterine
carcinosarcoma including any subtypes
3. Patients with a contraindication for doxorubicin OR patients must have received prior
chemotherapies
4. For patients with prior anthracycline therapy normal cardiac function with LVEF at
least 50% must be assessed by quantitative echocardiogram or MUGA scan
5. Prior Gemcitabine containing chemotherapy is permitted provided that at least 8 weeks
have elapsed since the last dose of therapy
6. ECOG performance status 0-1
7. At least 18 years old
8. Measurable disease according to RECIST v 1.1 criteria (in case of tumour debulking -
staging CT-scan after surgery)
9. Able to swallow and retain oral medication
10. Adequate organ system function as defined in Table 1
Table 1: Definitions for Adequate Organ Function System Laboratory Values Hematologic
Absolute neutrophil count (ANC) > = 1.5 X 109/L Hemoglobin1 > = 9 g/dL (5.6 mmol/L)
Platelets > = 100 X 109/L Prothrombin time (PT) or international normalized ratio (INR)4 <=
1.2 X upper limit of normal (ULN) Partial thromboplastin time (PTT) <=1.2 X ULN Hepatic2
Total bilirubin <= 1.5 X ULN AST and ALT <= 2.5 X ULN Renal Serum creatinine <= 1.5 mg/dL
(133 µmol/L)
Or, if greater than 1.5 mg/dL:
Calculated creatinine clearance > = 50 mL/min
Urine Protein to Creatinine Ratio (UPC)3 < 1
1. Subjects may not have had a transfusion within 7 days prior to screening assessment.
2. Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permitted
3. If UPC > = 1, then a 24-hour urine protein must be assessed. Subjects must have a
24-hour urine protein value <1g to be eligible.
4. Subjects receiving anticoagulant therapy are eligible if their INR is stable and
within the recommended range for the desired level of anticoagulation
11. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant),
including any female who has had:
- A hysterectomy
- A bilateral oophorectomy (ovariectomy)
- A bilateral tubal ligation
- Is post-menopausal Subjects not using hormone replacement therapy (HRT) must have
experienced total cessation of menses for = 1 year and be greater than 45 years in
age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40
mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
Subjects using HRT must have experienced total cessation of menses for >= 1 year and be
greater than 45 years of age OR have had documented evidence of menopause based on FSH and
estradiol concentrations prior to initiation of HRT
OR
Negative serum pregnancy test of women of childbearing potential performed within 1 week
prior to the first dose of study treatment, preferably as close to the first dose as
possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when
used consistently and in accordance with the product label and the instructions of the
physicians are as followed for 14 days before exposure to investigational product, through
the dosing period and for at least 21 days after the last dose of investigational product:
- Complete abstinence from sexual intercourse
- Oral contraceptive, either combined or progestogen alone
- Injectable progestogen
- Implants of levonorgestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate
of less than 1% per year
- Male partner sterilization (vasectomy with documentation of azoospermia) prior to the
female subject's entry into the study, and this male is the sole partner for that
subject
- Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps)
with a vaginal spermicidal agent (foam/gel/film/cream/suppository) Female subjects who
are lactating should discontinue nursing prior to the first dose of study drug and
should refrain from nursing throughout the treatment period and for 14 days following
the last dose of study drug.
Exclusion Criteria:
1. Prior malignancy
• Note: Subjects who have had another malignancy and have been disease-free for 5
years, or subjects with a history of completely resected non-melanomatous skin
carcinoma or successfully treated in situ carcinoma are eligible.
2. Patient has received prior treatment with any anti-angiogenic agent including
bevacizumab and tyrosine kinase inhibitors
3. Active malignancy or any malignancy in the last 5 years prior to first dose of study
drug other than LMS and CS
4. History or clinical evidence of central nervous system (CNS) or leptomeningeal
metastases, except for individuals who have previously-treated CNS metastases, are
asymptomatic, and have had no requirement for steroids or anti-seizure medication for
6 months prior to first dose of study drug. Screening with CNS imaging studies
(computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if
clinically indicated or if the subject has a history of CNS metastases
5. Clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease
- Known intraluminal metastatic lesion/s with risk of bleeding
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other
gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days prior to beginning study treatment
- Grade 3/4 diarrhea
6. Corrected QT interval (QTc) > 450 Milliseconds using Barzett's formula
7. History of any one or more of the following cardiovascular conditions within the past
6 months:
- Cardiac angioplasty or stenting
- Myocardial infarct",NULL,Progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder,Translational research program;Quality of life (EORTC QLQ-C30);Safety - side effects;Objective response rate (RECIST v1.1 criteria);Objective response rate (RECIST v1.1 criteria);Objective response rate (RECIST v1.1 criteria),NCT02203760; PazoDoble,2015-02-11,yes,Relapsed or Metastatic Uterine Leiomyosarcomas or Carcinosarcomas; Malignant neoplasm of other connective and soft tissue,Arm 1 Drug: Pazopanib plus Gemcitabine; Arm 2 Drug: Pazopanib,Interventional,Randomized controlled trial,Open (masking not used),Active control (effective treament of control group),Parallel,II,- progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder; time frame: 6 months
,- Objective response rate (RECIST v1.1 criteria); time frame: one year; Time to progression (TTP) of a patient being defined as the time in months from start of the first therapy cycle until PD is observed
- Objective response rate (RECIST v1.1 criteria); time frame: one year; Overall survival (OS) calculated from the day of study enrolment until the day of death
- Objective response rate (RECIST v1.1 criteria); time frame: one year; Progression-free survival (PFS) calculated from the day of study enrolment until the day of progression/death
- Safety; time frame: one year; Toxicity and tolerability
- Quality of life (EORTC QLQ-C30); time frame: one year; Quality of life (EORTC QLQ-C30)
- Translational research program; time frame: one year; Translational research within a tumour bank
,Germany,[---]* Berlin; [---]* Berlin; [---]* Chemnitz; [---]* Dresden; [---]* Essen; [---]* Freiburg; [---]* Greifswald; [---]* Hannover; [---]* Kiel; [---]* Lübeck; [---]* Marburg; [---]* Tübingen; [---]* Ulm,2013-09-30,NA,107,NA,"1. Subjects must provide informed consent prior to performance of study-specific
procedures or assessments, and must be willing to comply with treatment and
follow-up. Procedures conducted as part of the subject's routine clinical management
(e.g., blood count, imaging study) and obtained prior to signing of informed consent
may be utilized for screening or baseline purposes provided these procedures are
conducted as specified in the protocol
2. Histologically or cytological confirmed uterine leiomyosarcoma or uterine
carcinosarcoma including any subtypes
3. Patient must have received one or two prior chemotherapies
4. For patients with prior anthracycline therapy normal cardiac function with LVEF at
least 50% must be assessed by quantitative echocardiogram or MUGA scan
5. Prior Gemcitabine containing chemotherapy is permitted provided that at least 8 weeks
have elapsed since the last dose of therapy
6. ECOG performance status 0-1
7. At least 18 years old
8. Measurable disease according to RECIST v 1.1 criteria (in case of tumour debulking -
staging CT-scan after surgery)
9. Able to swallow and retain oral medication
10. Adequate organ system function as defined in Table 1
Table 1: Definitions for Adequate Organ Function System Laboratory Values Hematologic
Absolute neutrophil count (ANC) > = 1.5 X 109/L Hemoglobin1 > = 9 g/dL (5.6 mmol/L)
Platelets > = 100 X 109/L Prothrombin time (PT) or international normalized ratio
(INR)4 <= 1.2 X upper limit of normal (ULN) Partial thromboplastin time (PTT) <=1.2
X ULN Hepatic2 Total bilirubin <= 1.5 X ULN AST and ALT <= 2.5 X ULN Renal Serum
creatinine <= 1.5 mg/dL (133 µmol/L)
Or, if greater than 1.5 mg/dL:
Calculated creatinine clearance > = 50 mL/min
Urine Protein to Creatinine Ratio (UPC)3 < 1
1. Subjects may not have had a transfusion within 7 days prior to screening assessment.
2. Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN are not permitted
3. If UPC > = 1, then a 24-hour urine protein must be assessed. Subjects must have a
24-hour urine protein value <1g to be eligible.
4. Subjects receiving anticoagulant therapy are eligible if their INR is stable and
within the recommended range for the desired level of anticoagulation
11. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant),
including any female who has had:
- A hysterectomy
- A bilateral oophorectomy (ovariectomy)
- A bilateral tubal ligation
- Is post-menopausal Subjects not using hormone replacement therapy (HRT) must have
experienced total cessation of menses for ≥ 1 year and be greater than 45 years in
age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40
mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
Subjects using HRT must have experienced total cessation of menses for >= 1 year and be
greater than 45 years of age OR have had documented evidence of menopause based on FSH and
estradiol concentrations prior to initiation of HRT
OR
Negative serum pregnancy test of women of childbearing potential performed within 1 week
prior to the first dose of study treatment, preferably as close to the first dose as
possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when
used consistently and in accordance with the product label and the instructions of the
physicians are as followed for 14 days before exposure to investigational product, through
the dosing period and for at least 21 days after the last dose of investigational product:
- Complete abstinence from sexual intercourse
- Oral contraceptive, either combined or progestogen alone
- Injectable progestogen
- Implants of levonorgestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate
of less than 1% per year
- Male partner sterilization (vasectomy with documentation of azoospermia) prior to the
female subject's entry into the study, and this male is the sole partner for that
subject
- Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps)
with a vaginal spermicidal agent (foam/gel/film/cream/suppository) Female subjects
who are lactating should discontinue nursing prior to the first dose of study drug
and should refrain from nursing throughout the treatment period and for 14 days
following the last dose of study drug.
","1. Prior malignancy
• Note: Subjects who have had another malignancy and have been disease-free for 5
years, or subjects with a history of completely resected non-melanomatous skin
carcinoma or successfully treated in situ carcinoma are eligible.
2. Patient has received prior treatment with any anti-angiogenic agent including
bevacizumab and tyrosine kinase inhibitors
3. Active malignancy or any malignancy in the last 5 years prior to first dose of study
drug other than LMS and CS
4. History or clinical evidence of central nervous system (CNS) or leptomeningeal
metastases, except for individuals who have previously-treated CNS metastases, are
asymptomatic, and have had no requirement for steroids or anti-seizure medication for
6 months prior to first dose of study drug. Screening with CNS imaging studies
(computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if
clinically indicated or if the subject has a history of CNS metastases
5. Clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding including, but not limited to:
- Active peptic ulcer disease
- Known intraluminal metastatic lesion/s with risk of bleeding
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other
gastrointestinal conditions with increased risk of perforation
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days prior to beginning study treatment
- Grade 3/4 diarrhea
6. Corrected QT interval (QTc) > 450 Milliseconds using Barzett's formula
7. History of any one or more of the following cardiovascular conditions within the past
6 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery bypass graft surgery
- Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure, as defined by the New York Heart
Association (NYHA)
- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140
mmHg or diastolic blood pressure (DBP) of ≥ 90 mmHg].
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior
to study entry. BP must be re-assessed on two occasions that are separated by a
minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP
values from each BP assessment must be <140/90 mmHg in order for a subject to be
eligible for the study (refer to study protocol for details on BP control and
re-assessment prior to study enrollment)
8. History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6
months.
• Note: Subjects with recent DVT who have been treated with therapeutic
anti-coagulating agents for at least 6 weeks are eligible
9. Major surgery or trauma within 28 days prior to study enrolment or any non- healing
wound, fracture or ulcer (procedures such as catheter placement not considered to be
major)
10. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to Pazopanib or Gemcitabine
11. Evidence of active bleeding or bleeding diathesis
12. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
13. Hemoptysis in excess of 2.5 mL(or one half teaspoon) within 8 weeks prior to the
first dose of study drug
14. Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with subject's safety, provision of informed consent, or
compliance to study procedures
15. Unable or unwilling to discontinue use of prohibited medications listed in the study
protocol for at least 14 days or five half-lives of a drug (whichever is longer)
prior to the first dose of study drug and for the duration of the study
16. Treatment with any of the following anti-cancer therapies
- Radiation therapy, surgery or tumour embolization within 14 days prior to the
first dose of study drug
- Chemotherapy, immunotherapy, biologic therapy, investigational therapy or
hormonal therapy within 14 days or five half-lives of a drug (whichever is
longer) prior to the first dose of study drug
17. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is
progressing in severity, except alopecia
18. Pregnancy (for women of childbearing potential to be confirmed by negative serum
pregnancy test) or lactation period
Women of childbearing potential:
missing contraception (Pearl-Index <1, e.g. hormonal contraception including the
combined oral contraceptive pill, the transdermal patch, and the contraceptive
vaginal ring, intrauterine devices or sterilization) for 14 days before exposure to
investigational product, during study treatment and for at least 21 days after the
last dose of investigational product.
19. Medical or psychological conditions that would not permit the subject to complete the
study or sign informed consent
20. Legal incapacity or limited legal capacity
21. Participation in another clinical study with experimental therapy within 30 days
prior to study enrolment
","Pazopanib vs. Pazopanib Plus Gemcitabine in Patients With Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble -",Recruiting ongoing,University Medicine Greifswald; Universitätsmedizin Greifswald; [---]*,[---]*; [---]*; alexander.mustea@uni-greifswald.de,Arm 1 Drug: Pazopanib plus Gemcitabine; Arm 2 Drug: Pazopanib,2019-10-16,2014-05-05,2014-05-05,107,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,TRUE,TRUE,2019,NA,TRUE,TRUE,TRUE
22488,NA,DRKS00012473,DRKS00012473,NCT: NA ICTRP: 2017-06-08 DRKS: 2017-06-08,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,no AM,5,NA,NA,NCT: NA ICTRP: 30 DRKS: Tatsächlich 30,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no intervention,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,143/17,psychosomatic conditions in patients of a psychosomatic consultation in the workplace - pilot study,psychosomatic conditions in patients of a psychosomatic consultation in the workplace - pilot study ,elisabeth.balint@uniklinik-ulm.de,elisabeth.balint@uniklinik-ulm.de,Interventional,Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Treatment;,N/A,2017-06-08,2017-06-19,30,Complete: follow-up complete,"Klinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinik Ulm",NULL,germany,"Intervention 1: We recruite thirty consecutive patients consulting our PCIW. During the first or second session, the therapist informes the patient about the study. If the patient gives written informed consent, he is handed out a questionnaire which he should fill in within a week. The questionnaire containes the Work-Ability-Index Kurzform (WAI), Patient-Health-Questionnaire (PHQ), SF-12 (Short Form health questionnaire), Maslach-Burnout-Inventory (MBI-GS-D), and the Irritation Scale (IS). Diagnoses, medication, smoking status and BMI are obtained and documented by the therapist. To measure HRV, the patient receives a stingray and a one channel ECG device (eMotion Faros 180°, Mega Electronic) and he is shown how to use it. He is handed out the salivettes for measurement of cortisol in the saliva and is again shown how to use it. ECG measurement should start in the evening around 18 o'clock. Saliva is taken on the following day at 0, 15, 30, 45, 60 min., 6 and 8 hours after awakening and at bed time. At this day in the evening, the stingray is taken off.
If indicated, the patient receives a short time therapy. It contains the following topics: identification of problematic schemes, focussing on one of them and working on alternative strategies; identification of ressources and strengthening of them; strenghthening of self efficacy by promoting sports and relaxation training. The second measurement (after the intervention) is done only in patients who received at least four sessions and is analogous to the first. Three months after intervention the patient is sent the same questionnaire again and he is contacted by telephone to remember to fill in the questionnaire.",Inclusion criteria: staff of an institution for disabled persons that consults our psychosomatic consultation in the workplace that we established with this institution,Exclusion criteria: none,"Primary outcome are the circadian variation measures of heart rate variability i.e. the rhythm adjusted mean (MESOR), Amplitude (Day-Night Difference) and Acrophase (Phase-Shift of amplitude) of RMSSD (root mean sum of squares of successive differences)",Secondary outcome are total cortisol output i.e. AUCi,,2017-06-08,yes,psychosomatic complaints,"Arm 1 We recruite thirty consecutive patients consulting our PCIW. During the first or second session, the therapist informes the patient about the study. If the patient gives written informed consent, he is handed out a questionnaire which he should fill in within a week. The questionnaire containes the Work-Ability-Index Kurzform (WAI), Patient-Health-Questionnaire (PHQ), SF-12 (Short Form health questionnaire), Maslach-Burnout-Inventory (MBI-GS-D), and the Irritation Scale (IS). Diagnoses, medication, smoking status and BMI are obtained and documented by the therapist. To measure HRV, the patient receives a stingray and a one channel ECG device (eMotion Faros 180°, Mega Electronic) and he is shown how to use it. He is handed out the salivettes for measurement of cortisol in the saliva and is again shown how to use it. ECG measurement should start in the evening around 18 o'clock. Saliva is taken on the following day at 0, 15, 30, 45, 60 min., 6 and 8 hours after awakening and at bed time. At this day in the evening, the stingray is taken off.
If indicated, the patient receives a short time therapy. It contains the following topics: identification of problematic schemes, focussing on one of them and working on alternative strategies; identification of ressources and strengthening of them; strenghthening of self efficacy by promoting sports and relaxation training. The second measurement (after the intervention) is done only in patients who received at least four sessions and is analogous to the first. Three months after intervention the patient is sent the same questionnaire again and he is contacted by telephone to remember to fill in the questionnaire. ",Interventional,Single arm study,Open (masking not used),Uncontrolled/Single arm,Single (group),N/A,"Primary outcome are the circadian variation measures of heart rate variability i.e. the rhythm adjusted mean (MESOR), Amplitude (Day-Night Difference) and Acrophase (Phase-Shift of amplitude) of RMSSD (root mean sum of squares of successive differences)",Secondary outcome are total cortisol output i.e. AUCi,Germany,other Ursberg,2017-06-19,Actual,30,2020-04-15,staff of an institution for disabled persons that consults our psychosomatic consultation in the workplace that we established with this institution,none,psychosomatic conditions in patients of a psychosomatic consultation in the workplace - pilot study,"Recruiting complete, follow-up complete","Klinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinik Ulm; Klinik für Psychosomatische Medizin und PsychotherapieUniversitätsklinik Ulm; Klinik für Psychosomatische Medizin und PsychotherapieUniversitätsklinik Ulm",med.psychosomatik[at]uni-ulm.de ; elisabeth.balint@uniklinik-ulm.de; elisabeth.balint@uniklinik-ulm.de,"Arm 1 We recruite thirty consecutive patients consulting our PCIW. During the first or second session, the therapist informes the patient about the study. If the patient gives written informed consent, he is handed out a questionnaire which he should fill in within a week. The questionnaire containes the Work-Ability-Index Kurzform (WAI), Patient-Health-Questionnaire (PHQ), SF-12 (Short Form health questionnaire), Maslach-Burnout-Inventory (MBI-GS-D), and the Irritation Scale (IS). Diagnoses, medication, smoking status and BMI are obtained and documented by the therapist. To measure HRV, the patient receives a stingray and a one channel ECG device (eMotion Faros 180°, Mega Electronic) and he is shown how to use it. He is handed out the salivettes for measurement of cortisol in the saliva and is again shown how to use it. ECG measurement should start in the evening around 18 o'clock. Saliva is taken on the following day at 0, 15, 30, 45, 60 min., 6 and 8 hours after awakening and at bed time. At this day in the evening, the stingray is taken off.
If indicated, the patient receives a short time therapy. It contains the following topics: identification of problematic schemes, focussing on one of them and working on alternative strategies; identification of ressources and strengthening of them; strenghthening of self efficacy by promoting sports and relaxation training. The second measurement (after the intervention) is done only in patients who received at least four sessions and is analogous to the first. Three months after intervention the patient is sent the same questionnaire again and he is contacted by telephone to remember to fill in the questionnaire. ",2017-06-19,NA,2017-06-08,30,Interventional,FALSE,FALSE,NA,TRUE,TRUE,TRUE,FALSE,TRUE,TRUE,TRUE,2017,NA,FALSE,TRUE,FALSE
26866,NA,DRKS00002426,DRKS00002426,NCT: NA ICTRP: 2012-11-19 DRKS: 2012-11-19,1,1,NA,1,1,r,NA,2,1,NA,4,1,no measure,4,0,"no measure; best response reported only at end of study, not at all timepoints that are mentioned in register",NCT: NA ICTRP: 154 DRKS: [---]* 154,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1111/ejh.13281,NA,2006-12-27,NA,2006-10-31,2013-05-31,Interventional,Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma,Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75,Completed,Phase 3,154,Actual,Janssen-Cilag G.m.b.H,The difference in event-free survival time will be compared between both arms,"Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly",26866138MMY3013;CR006127,Consolidation Therapy With Bortezomib in Elderly Patients With Multiple Myeloma,Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75,,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 3,2006-12-22,2006-10-20,154,Completed,Janssen-Cilag G.m.b.H,NULL,germany,Drug: Bortezomib,"
Inclusion Criteria:
- Patients who have had pretreatment with single or tandem high dose melphalan therapy
and autologous stem cell transplantation as first line therapy
- at least stable disease after stem cell transplantation
- adequate hematological, hepatic and renal lab parameters
- karnofsky status of 70 or more
Exclusion Criteria:
- non-secretory multiple myeloma
- previous treatment with bortezomib
- allogenic stem cell transplantation
- other co-existing malignancy beside basaliome
- peripheral neuropathy
- epilepsia
- other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious
etc.)
- history of allergic reactions to bortezomib or mannitol
- expected life expectancy of less than 3 months
",NULL,The difference in event-free survival time will be compared between both arms,"Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly",NCT00416208; CR006127; 26866138MMY3013,2012-11-19,no,Multiple Myeloma; Multiple myeloma,Arm 1 Drug: Bortezomib,Interventional,Randomized controlled trial,Open (masking not used),Control group receives no treatment,Parallel,III,"- The difference in event-free survival time will be compared between both arms; time frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up
","- Best response to chemotherapy, response rate to chemotherapy , duration of response, toxicities and quality of life; timepoints for assessments will be at end of study, at 1,5 + 4 + 8 +12 + 18 + 24 + 30 months and thereafter 6 monthly; time frame: Every 35 days during treatment phase, after 4, 8, 12, 18, 24 months during follow-up
",Germany,[---]* Bamberg; [---]* Berg; [---]* Berlin; [---]* Bremen; [---]* Dortmund; [---]* Dresden; [---]* Duisburg; [---]* Erlangen; [---]* Eschweiler; [---]* Frankfurt / Main; [---]* Freiburg; [---]* Goch; [---]* Greifswald; [---]* Göttingen; [---]* Halle; [---]* Hamburg; [---]* Hamm; [---]* Jena; [---]* Karlsruhe; [---]* Kempten,2006-10-31,NA,154,2013-05-01,"- Patients who have had pretreatment with single or tandem high dose melphalan therapy
and autologous stem cell transplantation as first line therapy
- at least stable disease after stem cell transplantation
- adequate hematological, hepatic and renal lab parameters
- karnofsky status of 70 or more
","- non-secretory multiple myeloma
- previous treatment with bortezomib
- allogenic stem cell transplantation
- other co-existing malignancy beside basaliome
- peripheral neuropathy
- epilepsia
- other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious
etc.)
- history of allergic reactions to bortezomib or mannitol
- expected life expectancy of less than 3 months
",Consolidation Therapy With Bortezomib in Patients With Multiple Myeloma Aged 61 to 75,"Recruiting complete, follow-up complete",Janssen-Cilag G.m.b.H; Janssen-Cilag G.m.b.HJanssen-Cilag G.m.b.H Clinical Trial; Janssen-Cilag G.m.b.HJanssen-Cilag G.m.b.H Clinical Trial,[---]*; [---]*; [---]*,Arm 1 Drug: Bortezomib,2006-10-31,2006-12-22,2006-12-22,154,Interventional,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2006,NA,TRUE,TRUE,TRUE
24160,NA,DRKS00009741,DRKS00009741,NCT: NA ICTRP: 2015-12-04 DRKS: 2015-12-04,1,1,NA,2,1,NA,NA,2,0,"NA; Different intervention, but this is the paper linked as ""publication"" in the registry",4,0,no AM,4,1,no AM,NCT: NA ICTRP: 125 DRKS: Tatsächlich 125,166,1,NA,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1371/journal.pone.0105670,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,EK137062007,"Predictors, consequences and changeability of psychoneuroendrocrinologically stress response in social phobia","Predictors, consequences and changeability of psychoneuroendrocrinologically stress response in social phobia ",juergen.hoyer@tu-dresden.de,juergen.hoyer@tu-dresden.de,Interventional,Allocation: Randomized controlled trial;. Masking: Open (masking not used). Control: Control group receives no treatment|Other. Assignment: Parallel. Study design purpose: Basic research/physiological study;,N/A,2015-12-04,2009-10-02,125,Complete: follow-up complete,Technische Universität DredenInstitut für Klinische Psychologie und Psychotherapie,NULL,germany,"Intervention 1: Treatment group: Patients with Social Phobia who got 25 sessions cognitive therapy à 50 minutes according to the manual of Stangier, Clark and Ehlers (2006) between the first and the second measuring time. At three measuring time (before therapy, after, therapy, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. Intervention 2: Waitlist control group: Patients with Social Phobia who got no intervention between the first and the second measuring time. At three measuring time (before wait time, after wait time, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. Intervention 3: Health controls: Healthy participants who got no intervention between the first and the second measuring time. At three measuring times (pre, after 4-6 month, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated.",Inclusion criteria: Diagnosis of social phobia according to the DSM-IV as primary diagnosis as well as a sum score > 30 in the Liebowith social anxiety scale (LSAS),"Exclusion criteria: Psychotic Disorder (acute or lifetime); Self-endangerment; current substance disorder; current personality disorder except avoidant, compulsive or dependent personality disorder; organically caused mental disorder; serious physical illness; current psychotherapeutic or psychopharmacological treatment","Reduction in the Liebowitz Social Anxiety Scale (LSAS; German version: Stangier & Heidenreich, 2005) between baseline and post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.","Blood or plasma cortisol during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) at baseline and at the post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.",,2015-12-04,yes,Social phobias,"Arm 1 Treatment group: Patients with Social Phobia who got 25 sessions cognitive therapy à 50 minutes according to the manual of Stangier, Clark and Ehlers (2006) between the first and the second measuring time. At three measuring time (before therapy, after, therapy, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. ; Arm 2 Waitlist control group: Patients with Social Phobia who got no intervention between the first and the second measuring time. At three measuring time (before wait time, after wait time, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. ; Arm 3 Health controls: Healthy participants who got no intervention between the first and the second measuring time. At three measuring times (pre, after 4-6 month, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. ",Interventional,Randomized controlled trial,Open (masking not used),Control group receives no treatment|Other,Parallel,N/A,"Reduction in the Liebowitz Social Anxiety Scale (LSAS; German version: Stangier & Heidenreich, 2005) between baseline and post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.","Blood or plasma cortisol during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) at baseline and at the post-measuring time (after 25 sessions cognitive therapy or a wait time of 4-6 month) respectively the 6-month-follow-up.",Germany,Doctor's Practice Dresden,2009-10-02,Actual,125,2013-02-05,Diagnosis of social phobia according to the DSM-IV as primary diagnosis as well as a sum score > 30 in the Liebowith social anxiety scale (LSAS),"Psychotic Disorder (acute or lifetime); Self-endangerment; current substance disorder; current personality disorder except avoidant, compulsive or dependent personality disorder; organically caused mental disorder; serious physical illness; current psychotherapeutic or psychopharmacological treatment
","Predictors, consequences and changeability of psychoneuroendrocrinologically stress response in social phobia","Recruiting complete, follow-up complete",Technische Universität DredenInstitut für Klinische Psychologie und Psychotherapie; TU Dresden; TU Dresden,juergen.hoyer@tu-dresden.de; juergen.hoyer@tu-dresden.de; juergen.hoyer@tu-dresden.de,"Arm 1 Treatment group: Patients with Social Phobia who got 25 sessions cognitive therapy à 50 minutes according to the manual of Stangier, Clark and Ehlers (2006) between the first and the second measuring time. At three measuring time (before therapy, after, therapy, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. ; Arm 2 Waitlist control group: Patients with Social Phobia who got no intervention between the first and the second measuring time. At three measuring time (before wait time, after wait time, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. ; Arm 3 Health controls: Healthy participants who got no intervention between the first and the second measuring time. At three measuring times (pre, after 4-6 month, 6-month-follow-up), the subjective and psychoneuroendrocrinologically stress response during the Trier Social Stress Test (Kirschbaum, Pirke, & Hellhammer, 1993) was investigated. ",2009-10-02,NA,2015-12-04,125,Interventional,FALSE,TRUE,NA,FALSE,FALSE,FALSE,FALSE,TRUE,TRUE,TRUE,2009,NA,FALSE,TRUE,FALSE
20576,NA,DRKS00015097,DRKS00015097,NCT: NA ICTRP: 2019-01-15 DRKS: 2019-01-15,1,NA,NA,2,NA,NA,NA,NA,NA,NA,2,NA,NA,2,NA,NA,NCT: NA ICTRP: 90000 DRKS: Tatsächlich 90000,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,18-545,Prevention of Familial Risk of Colorectal Carcinoma,Prevention of Familial Risk of Colorectal Carcinoma - FARKOR ,mansmann@ibe.med.uni-muenchen.de,FARKOR@KVB.de,Observational,Allocation: Non-randomized controlled trial;. Masking: Open (masking not used). Control: Control group receives no treatment. Assignment: Parallel. Study design purpose: Screening;,IV,2019-01-15,2018-10-01,90000,Recruiting,Kassenärztliche Vereinigung Bayerns,NULL,germany,"Intervention 1: Members of statutory health insurance between 25 and 50 years living in Bavaria are invited to participate in the study.
Based on a short questionnaire on their family history of colorectal cancer (CRC), which is a simplified version of the Amsterdam and Bethesda criteria, participants are classified as potential risk carrier or as risk free.
Participants with a family history of CRC can decide to undergo an iFOBT (fecal immunochemical test), a screening colonoscopy, or deferring further actions to a later point in life.
Participants in arm 1 are study participants with a family history of CRC who decide for one of the proposed screening measures. Intervention 2: Participants between 25 and 50 years living in Bavaria without family history of CRC Intervention 3: In arm 3, the incidence of CRC in members of statutory health insurance companies between 25 and 50 years of age living in Bavaria who do not participate in the study will be monitored through health administrative databases.","Inclusion criteria: 25 -> 50 year-old persons of both genders, with and without family history of CRC, who gave their written consent to participate in the project","Exclusion criteria: Individuals for whom adequate CRC related screening measures already exist are excluded from the study. In particular, patients with an increased risk of CRC due to a known disease (family history of adenomatous polyposis, chronic inflammatory bowel diseases (ulcerative colitis, Chron's disease)) or with a previous diagnosis of CRC will be excluded, as well as patients over 50 years of age for whom CRC screening already exists.",The incidence of adenoma and of CRC in study participants who undergo one of the proposed screening options will be measured in the context of this screening option.
The incidence of adenoma and of CRC in study participants who do not participate in any screening measures and in those who do not participate in the program will be estimated based on administrative health records during the project period. The statistical analysis will take the difference in detection probabilities of adenoma and of CRC in the different groups in account.,- participation rate
- number of complications arising in the screening colonoscopies in the program
- positive predictive value of iFOBT (immunological fecal occult blood test): frequency of true and false positive findings,,2019-01-15,yes,"Malignant neoplasm of colon; Malignant neoplasm of rectosigmoid junction; Malignant neoplasm of rectum; Benign neoplasm of colon, rectum, anus and anal canal","Arm 1 Members of statutory health insurance between 25 and 50 years living in Bavaria are invited to participate in the study.
Based on a short questionnaire on their family history of colorectal cancer (CRC), which is a simplified version of the Amsterdam and Bethesda criteria, participants are classified as potential risk carrier or as risk free.
Participants with a family history of CRC can decide to undergo an iFOBT (fecal immunochemical test), a screening colonoscopy, or deferring further actions to a later point in life.
Participants in arm 1 are study participants with a family history of CRC who decide for one of the proposed screening measures. ; Arm 2 Participants between 25 and 50 years living in Bavaria without family history of CRC; Arm 3 In arm 3, the incidence of CRC in members of statutory health insurance companies between 25 and 50 years of age living in Bavaria who do not participate in the study will be monitored through health administrative databases. ",Non-interventional,Non-randomized controlled trial,Open (masking not used),Control group receives no treatment,Parallel,IV,The incidence of adenoma and of CRC in study participants who undergo one of the proposed screening options will be measured in the context of this screening option.
The incidence of adenoma and of CRC in study participants who do not participate in any screening measures and in those who do not participate in the program will be estimated based on administrative health records during the project period. The statistical analysis will take the difference in detection probabilities of adenoma and of CRC in the different groups in account.
,- participation rate
- number of complications arising in the screening colonoscopies in the program
- positive predictive value of iFOBT (immunological fecal occult blood test): frequency of true and false positive findings,Germany,Doctor's Practice Bayern; Doctor's Practice Bayern,2018-10-01,Actual,90000,NA,"25 -> 50 year-old persons of both genders, with and without family history of CRC, who gave their written consent to participate in the project","Individuals for whom adequate CRC related screening measures already exist are excluded from the study. In particular, patients with an increased risk of CRC due to a known disease (family history of adenomatous polyposis, chronic inflammatory bowel diseases (ulcerative colitis, Chron's disease)) or with a previous diagnosis of CRC will be excluded, as well as patients over 50 years of age for whom CRC screening already exists.
",Prevention of Familial Risk of Colorectal Carcinoma
,Recruiting ongoing,Kassenärztliche Vereinigung Bayerns; Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie; Kassenärztliche Vereinigung Bayerns (KVB) FARKOR Koordinationsstelle,FARKOR@KVB.de; mansmann@ibe.med.uni-muenchen.de; FARKOR@KVB.de,"Arm 1 Members of statutory health insurance between 25 and 50 years living in Bavaria are invited to participate in the study.
Based on a short questionnaire on their family history of colorectal cancer (CRC), which is a simplified version of the Amsterdam and Bethesda criteria, participants are classified as potential risk carrier or as risk free.
Participants with a family history of CRC can decide to undergo an iFOBT (fecal immunochemical test), a screening colonoscopy, or deferring further actions to a later point in life.
Participants in arm 1 are study participants with a family history of CRC who decide for one of the proposed screening measures. ; Arm 2 Participants between 25 and 50 years living in Bavaria without family history of CRC; Arm 3 In arm 3, the incidence of CRC in members of statutory health insurance companies between 25 and 50 years of age living in Bavaria who do not participate in the study will be monitored through health administrative databases. ",2018-10-01,NA,2019-01-15,90000,Observational,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,FALSE,2018,NA,FALSE,TRUE,FALSE
30227,NA,NA,EUCTR2005-004893-26,NCT: NA ICTRP: 2006-02-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,NA,NA,NA,NCT: NA ICTRP: 30 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-01-19,NA,2006-01-31,2023-07-03,Interventional,Faslodex in McCune Albright Syndrome,"An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome","Active, not recruiting",Phase 2,30,Actual,AstraZeneca,Change in the Frequency of Annualised Days of Vaginal Bleeding,Percentage of Participants With Baseline Vaginal Bleeding Who Experienced ≥50% Reduction in the Number of Vaginal Bleeding Days;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6 Month Trial Period.;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding .;Change in Bone Age Advancement Over the First 6 Month Trial Period.;Change in Bone Age Advancement Over the Second 6 Month Trial Period.;Change in Bone Age Advancement Over the Whole 12 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the First 6 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Second 6 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Whole 12 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the First 6 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the Second 6 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the Whole 12 Month Trial Period.;Change in Uterine Volume From Baseline to Month 12 by Ultrasound.;Change in Uterine Volume From Baseline to Month 6 by Ultrasound.;Change in Uterine Volume From Month 6 to Month 12 by Ultrasound.;Change in Ovarian Volume From Baseline to Month 12 by Ultrasound.;Change in Ovarian Volume From Baseline to Month 6 by Ultrasound.;Change in Ovarian Volume From Month 6 to Month 12 by Ultrasound.;Hormone Assays: Serum Oestradiol.;Hormone Assays: Luteinizing Hormone (LH).;Hormone Assays: Follicle-stimulating Hormone (FSH).;Hormone Assays: Testosterone.;PK: Mean Clearance.;PK: Mean Volume of Distribution (V1/F);PK: Mean Volume of Distribution (V2/F) .;Change in Breast Tanner Stage From Baseline to Month 12.;Change in Pubic Tanner Stage From Baseline to Month 12.;Change in Predicted Adult Height (PAH) From Baseline to Month 12.;Percentage of Patients With Gsα Mutation.,EUDRACT Number: 2005-004893-29;D6992C00044,Faslodex in McCune Albright Syndrome,"An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome",,,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2006-01-17,2006-01-31,30,"Active, not recruiting",AstraZeneca,NULL,united states;france;germany;italy;russian federation;united kingdom;france;germany;italy;russian federation;united kingdom;united states;spain,Drug: Fulvestrant,
Inclusion Criteria:
- Females less than or equal to 10 years of age (prior to 11th birthday)
- Diagnosis of McCune-Albright syndrome (MAS)
- Progressive precocious puberty (PPP) associated with MAS
Exclusion Criteria:
- Received any prior treatment for PPP associated with MAS with fulvestrant
- Abnormal platelet count or liver function tests
- Bleeding disorders
- Long term anticoagulation therapy
- Known hypersensitivity to any component of the study drug
,NULL,Change in the Frequency of Annualised Days of Vaginal Bleeding,Hormone Assays: Luteinizing Hormone (LH).;Hormone Assays: Follicle-stimulating Hormone (FSH).;Hormone Assays: Testosterone.;PK: Mean Clearance.;PK: Mean Volume of Distribution (V1/F);PK: Mean Volume of Distribution (V2/F) .;Change in Breast Tanner Stage From Baseline to Month 12.;Change in Pubic Tanner Stage From Baseline to Month 12.;Change in Predicted Adult Height (PAH) From Baseline to Month 12.;Percentage of Patients With Gsa Mutation.;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced =50% Reduction in the Number of Vaginal Bleeding Days;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding Over a 6 Month Trial Period.;Percentage of Participants With Baseline Vaginal Bleeding Who Experienced Cessation of Vaginal Bleeding .;Change in Bone Age Advancement Over the First 6 Month Trial Period.;Change in Bone Age Advancement Over the Second 6 Month Trial Period.;Change in Bone Age Advancement Over the Whole 12 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the First 6 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Second 6 Month Trial Period.;Change in Growth Velocity (Annualised Growth Velocity i.e. cm/y) Over the Whole 12 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the First 6 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the Second 6 Month Trial Period.;Change in Growth Velocity (Z-Score) Over the Whole 12 Month Trial Period.;Change in Uterine Volume From Baseline to Month 12 by Ultrasound.;Change in Uterine Volume From Baseline to Month 6 by Ultrasound.;Change in Uterine Volume From Month 6 to Month 12 by Ultrasound.;Change in Ovarian Volume From Baseline to Month 12 by Ultrasound.;Change in Ovarian Volume From Baseline to Month 6 by Ultrasound.;Change in Ovarian Volume From Month 6 to Month 12 by Ultrasound.;Hormone Assays: Serum Oestradiol.,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-01-31,2006-01-17,2006-01-17,30,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2006,NA,TRUE,FALSE,TRUE
35317,NA,NA,EUCTR2017-000419-17,NCT: NA ICTRP: 2017-10-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,3 points but no time frame or intervals,2,NA,"""Progression free survival"", no AM, no time frame, no measure",4,NA,no AM,NCT: NA ICTRP: 496 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-10-28,NA,2017-06-21,2026-02-28,Interventional,"Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer","A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer",Recruiting,Phase 3,496,Anticipated,"Alliance Foundation Trials, LLC.",Progression-free survival (PFS) as assessed by Investigator,Overall Survival (OS);3 and 5 year survival probabilities;Objective Response Rate (OR: CR or PRR);Duration of Response (DOR);Clinical Benefit Rate (CBR: CR or PR or SD ≥ 24 weeks;Safety: Type incidence and severity (as graded by NCI CTCAE v 4.0);Patient Reported Outcomes,AFT-38,"Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer","A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy After Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer",;patina@alliancefoundationtrials.org;,;patina@alliancefoundationtrials.org;,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2016-10-26,2017-06-21,496,Recruiting,"Alliance Foundation Trials, LLC.","Pfizer;German Breast Group;Fondazione Michelangelo;PrECOG, LLC.;Breast Cancer Trials, Australia and New Zealand;Syneos Health;SOLTI Breast Cancer Research Group;UNICANCER",united states;australia;france;germany;italy;new zealand;spain;australia;france;germany;italy;new zealand;spain;united states,Drug: palbociclib;Drug: trastuzumab;Drug: pertuzumab;Drug: letrozole;Drug: Anastrozole;Drug: Exemestane;Drug: Fulvestrant,"
Inclusion Criteria (Preliminary Screening)
1. Signed Preliminary Screening Informed Consent Form obtained prior to any study
specific assessments and procedures
2. Age =18 years (or per national guidelines)
3. Patients must have histologically confirmed invasive breast cancer that is metastatic
or not amenable for resection or radiation therapy with curative intent. Histological
documentation of metastatic/recurrent breast cancer is not required if there is
unequivocal evidence for recurrence of the breast cancer.
4. Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+
and/or PR+), metastatic breast cancer. ER, PR and HER2 measurements should be
performed according to institutional guidelines, in a CLIA-approved setting in the US
or certified laboratories for Non-US regions. Cut-off values for positive/negative
staining should be in accordance with current ASCO/CAP (American Society of Clinical
Oncology/College of American Pathologists) guidelines.
5. Patients must agree to provide a representative formalin-fixed paraffin-embedded
(FFPE) tumor tissue block (preferred) from primary breast or metastatic site
(archival) OR at least 15 freshly cut unstained slides from such a block, along with a
pathology report documenting HER2 positivity and hormone receptor positivity.
6. Patients should be willing to provide a representative tumor specimen obtained from
recently biopsied metastatic disease if clinically feasible. This is recommended but
optional tissue.
Inclusion Criteria (Randomization Screening)
7. Signed Main Informed Consent Form obtained prior to any study specific assessments and
procedures
8. Age = 18 years (or per national guidelines)
9. ECOG performance status 0-1
10. Patients must be able and willing to swallow and retain oral medication without a
condition that would interfere with enteric absorption.
11. Serum or urine pregnancy test must be negative within 7 days of randomization in women
of childbearing potential. Pregnancy testing does not need to be pursued in patients
who are judged as postmenopausal before randomization, as determined by local
practice, or who have undergone bilateral oophorectomy, total hysterectomy, or
bilateral tubal ligation. Women of childbearing potential and male patients randomized
into the study must use adequate contraception for the duration of protocol treatment
which is 6 months after the last treatment with palbociclib if they are in Arm A and
for 7 months after last treatment with trastuzumab if in either Arm A or Arm B
Adequate contraception is defined as one highly effective form (i.e. abstinence,
(fe)male sterilization OR two effective forms (e.g. non-hormonal IUD and condom /
occlusive cap with spermicidal foam / gel / film / cream / suppository).
12. Resolution of all acute toxic effects of prior induction anti-HER2-based chemotherapy
regimen to NCI CTCAE version 4.0 Grade =1 (except alopecia or other toxicities not
considered a safety risk for the patient at investigator's discretion) 12 weeks
between last dose of chemotherapy-anti-HER2therapy and randomization are allowed.
Endocrine therapy could start before study randomization.
13. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures
Prior Treatment Specifics
14. Patients may or may not have received neo/adjuvant therapy, but must have a
disease-free interval from completion of anti-HER2 therapy to metastatic diagnosis =6
months.
15. Patients must have received an acceptable, standard, chemotherapy containing anti-HER2
based induction therapy for the treatment of metastatic breast cancer prior to study
enrollment. For this study, chemotherapy is limited to a taxane or vinorelbine (only
for trastuzumab-based regimen). Eligible patients are expected to have completed 6
cycles of chemotherapy containing anti-HER2-therapy treatment. A minimum of 4 cycles
of treatment is acceptable for patients experiencing significant toxicity associated
with treatment as long as they are without evidence of disease progression (i.e. CR,
PR or SD). The maximum number of cycles is 8. Patients can randomize immediately
following completion of their induction therapy, or for those who have already
completed induction, a gap of 12 weeks between their last infusion/dose of induction
therapy and the C1D1 visit is permitted. Patients are eligible provided they are
without evidence of disease progression by local assessment (i.e. CR, PR or SD).
16. Patients with a history or presence of asymptomatic CNS metastases are eligible,
provided they meet all of the following criteria:
- Disease outside the CNS is present.
- No evidence of interim progression between the completion of induction therapy
and the screening radiographic study
- No history of intracranial hemorrhage or spinal cord hemorrhage
- Not requiring anti-convulsants for symptomatic control
- Minimum of 3 weeks between completion of CNS radiotherapy and Cycle 1 Day 1 and
recovery from significant (Grade = 3) acute toxicity with no ongoing requirement
for corticosteroid
Baseline Body Function Specifics
17. Absolute neutrophil count = 1,000/mm3
18. Platelets = 100,000/mm3
19. Hemoglobin = 10g/dL
20. Total serum bilirubin = ULN; or total bilirubin = 3.0 × ULN with direct bilirubin
within normal range in patients with documented Gilbert's Syndrome.
21. Aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) =
3 × institutional ULN (=5 x ULN if liver metastases are present).
22. Serum creatinine below the upper limit of normal (ULN) of the institutional normal
range or creatinine clearance = 60 mL/min/1.73 m2 for patients with serum creatinine
levels above institutional ULN.
23. Left ventricular ejection fraction (LVEF) = 50% at baseline as determined by either
ECHO or MUGA
Exclusion Criteria (Randomization)
1. Concurrent therapy with other Investigational Products.
2. Prior therapy with any CDK 4/6 inhibitor.
3. History of allergic reactions attributed to compounds of chemical or biologic
composition similar to palbociclib.
4. Patients receiving any medications or substances that are strong inhibitors or
inducers of CYP3A isoenzymes within 7 days of randomization (see Section 8.6.3 for
list of strong inhibitors or inducers of CYP3A isoe",NULL,Progression-free survival (PFS) as assessed by Investigator,Overall Survival (OS);3 and 5 year survival probabilities;Objective Response Rate (OR: CR or PRR);Duration of Response (DOR);Clinical Benefit Rate (CBR: CR or PR or SD = 24 weeks;Safety: Type incidence and severity (as graded by NCI CTCAE v 4.0);Patient Reported Outcomes,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-06-21,2016-10-26,2016-10-26,496,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,NA,TRUE,FALSE,TRUE
23811,NA,NA,RBR-3dccf6,NCT: NA ICTRP: 2016-03-30 DRKS: NA,1,1,NA,2,1,NA,NA,2,1,NA,3,1,"no total follow up time, no cutpoint for remission",4,1,No total follow up time,NCT: NA ICTRP: 333 DRKS: NA,297,1,1,2,1,NA,Double,Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1001/jamapsychiatry.2019.1189,2019-06-05,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NULL,A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Avoiding in Adult Participants With Treatment-resistantDepression,A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistantDepression ,nortonsayeg@uol.com.br,vrighi@its.jnj.com,Interventional,"Clinical study, parallel, 2-arm, double-blind, randomized controlled, phase 3, prospective",3,2016-03-30,2015-07-09,NA,Recruiting,Clinica Dr. Norton Sayeg Ltda. EPP,Janssen-Cilag Farmacêutica Ltda.,belgium;brazil;canada;czech republic;france;germany;hungary;italy;mexico;poland;spain;turkey;united states,"Esketamine group; 167 participantes: Open-label induction phase: Direct entry participants start at a dose of 56 mg on Day 1. From Day 4 to 15, dose may be adjusted per protocol at investigator’s discretion based on efficacy and/or tolerability; Optimization Phase: Direct-entry and transferred-entry participants will and self-administer intranasal esketamine (same dose) for first 4 weeks, then individualized to either once weekly or once every other week based on depressive symptoms. Maintenance Phase: All participants assigned to esketamine will self-administer intranasal esketamine once weekly or once every other week based on depressive symptoms. Placebo Optimization Phase; 166 participants: Transferred-entry participant will self-administer intranasal placebo at weekly treatment sessions for the first 4 weeks of this phase, then individualized to either once weekly or once every other week based on depressive symptoms. Maintenance Phase: Direct-entry and transferred-entry participants assigned to placebo will self-administer matching intranasal placebo once weekly or once based on depressive symptoms;Drug;D27.505.954.427.700.122","Inclusion criteria: Inclusion Criteria: At the time of signing the informed consent form (ICF), participant must be a man or woman 18 (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18) to 64 years of age, inclusive - At the start of the screening/prospective observational phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single-episode MDD, the duration must be greater than or equal to [>=] 2 years) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the Mini- International Neuropsychiatric Interview (MINI) - At the start of the screening/prospective observational phase, participant must have an Inventory of Depressive Symptomatology-Clinician rated ( IDS-C30) total score of greater than or equal to (>=) 34 - At the start of the screening/prospective observational phase, participants must have had nonresponse to >=2 but less than or equal to (<=) 5 oral antidepressant treatments taken at adequate dosage and for adequate duration, as assessed using the Massachusetts General Hospital – Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and documented by medical history and pharmacy/prescription records, for the current episode of depression - The participant’s current major depressive episode and treatment response to antidepressant treatments used in the current depressive episode (retrospectively assessed) must be deemed valid for participation in a clinical study based on a Site-Independent Qualification Assessment For Transferred-Entry Participants - The participant must have completed the double-blind induction phase in ESKETINTRD3001 or ESKETINTRD3002 and must have demonstrated response at the end of that phase (>=50% reduction in the MADRS total score from baseline [Day 1 pre-randomization] at the end of the 4-week double-blind induction phase)","Exclusion criteria: Exclusion Criteria: - Participants who have previously demonstrated nonresponse of depressive symptoms to esketamine or ketamine in the current major depressive episode, to all 4 of the oral antidepressant treatment options available for the double-blind induction phase (ie, duloxetine, escitalopram, sertraline, and venlafaxine extended release [XR]) in the current major depressive episode (based on MGH-ATRQ), or an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral ECT – Participant currently has an implant for vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression - Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders (confirmed by the MINI), comorbid obsessive compulsive disorder, intellectual disability (only DSM-5 diagnostic code 319), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder - Participant has homicidal ideation/intent, per the investigator’s clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening/prospective observational phase, per the investigator’s clinical judgment or based on the Columbia Suicide Severity Rating Scale (CSSRS) - Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria","Time to relapse in Participants with stable remission who were randomized in the maintenance phase - Relapse is defined as any of the following: (1) MADRS total score ? 22 for 2 consecutive assessments separated by 5 to 15 days (inclusive); or (2) Hospitalization for worsening depression, for a suicide attempt or for suicide prevention. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. ","Time to relapse in Participants with Stable Response (but not in stable remission) who were randomized in the maintenance phase - Time between participant randomization into the maintenance phase and the first documentation of a relapse event;Change From Baseline in MADRS total score at end of the Maintenance Phase in participants who were randomized in this phase - The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts.Change From Baseline in Subject-reported Depressive Symptoms Using the Patient Health Questionnaire-9 (PHQ-9) Total Score at End of the Maintenance Phase in participants who were randomized in this phase - The PHQ-9 is a 9-item scale used to assess depressive symptoms. Change From Baseline in Clinical Global Impression – Severity (CGI-S) Score at End of Maintenance Phase in participants who were randomized in this phase - The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating. The CGI-S permits a global evaluation of the participant’s condition at a given time. Change From Baseline in Subject-reported Generalized Anxiety Disorder (GAD-7) Score at End of Maintenance Phase in participants who were randomized in this phase - The GAD-7 is a brief and validated measure of overall anxiety. Item responses are summed to yield a total score with range of 0 to 21, where higher scores indicate more anxiety. Change From Baseline in Subject-reported Healthrelated Quality of Life and Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ- 5D-5L) at End of Maintenance Phase in participants who were randomized in this phase - The EQ-5D-5L is a standardized instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It consists of the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems (Level 1 indicating no problem, and Level 5 indicating extreme problems). The participant selects an answer for each of the 5 dimensions considering the response that best matches his or her health today.” The descriptive system can be represented as a health state. The EQ-VAS records the respondent’s own assessment of his or her overall health status at the time of completion, on a scale of 0 to 100.; Change From Baseline in Sheehan Disability Scale (SDS) Total Score at End of Maintenance Phase in participants who were randomized in this phase - The SDS is a subject-reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. ",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-07-09,NA,2016-03-30,333,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2015,NA,FALSE,FALSE,FALSE
33083,NA,NA,EUCTR2011-002145-35,NCT: NA ICTRP: 2012-07-24 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,2,NA,"No time frame, no measure (definition of progression)",3,NA,"no time frame, no measure",NCT: NA ICTRP: 146 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2012-08-29,NA,NA,NA,Interventional,TS Stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV,TS Stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV,Withdrawn,Phase 2,0,Actual,Aktion Bronchialkarzinom e.V.,Progression free survival,Overall survival;Quality of life;Response rate;Molecular investigations,2011-002145-35;ABC-2011-NSCLC-03,TS Stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV,TS Stratified Chemotherapy and VEGF Inhibition in Non-Squamous Non-Small Cell Lung Cancer - Stage IV,;;;;,;;;;,Interventional,"Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 2,2012-08-23,2012-08-20,0,Withdrawn,Aktion Bronchialkarzinom e.V.,Roche Pharma AG;Eli Lilly and Company,germany,Drug: Pemetrexed;Drug: Cisplatin;Drug: Bevacizumab,"
Inclusion Criteria:
- Histological confirmed Non-Small-Cell lung cancer
- Tumor stage IV (UICC 7th Version)
- The following histological tumor types are eligible:
- Adenocarcinoma (including adenocarcinomas with bronchioloalveolar
differentiation)
- Large Cell carcinoma without neuroendocrine differentiation
- Mixed Cell Carcinoma without small cell fraction and without predominant
squamous cell fraction
- undifferentiated non-small-cell-carcinoma
- No previous chemotherapy for stage IV NSCLC
- Adjuvant or neoadjuvant chemotherapy for NSCLC must be completed at least one year
prior to study enrolment (from end of chemotherapy)
- No previous treatment with Pemetrexed or Bevacizumab
- Patients with prior radiation therapy may be eligible for this study if they meet the
following guidelines:
- Previous radiation therapy is allowed to <25% of the bone marrow (Cristy and
Eckerman 1987), but should have been limited and must not have included whole
pelvis radiation.
- Patients must have recovered from the toxic effects of the treatment prior to
study enrollment (except for alopecia).
- Prior thoracic radiotherapy must be completed 30 days before study enrollment.
- Lesions that have been radiated cannot be included as sites of measurable
disease unless clear tumor progression has been documented in these lesions
since the end of radiation therapy.
- Palliative extrathoracic radiotherapy to preexisting lesions may continue on
study; however, these lesions may not be included as sites of measurable
disease.
- At least 4 weeks since last major surgery
- Age = 18 and = 70 years
- ECOG = 1
- Adequate hematological laboratory parameters:
- Hemoglobin =9 g/dl
- Neutrophils = 1.500 µl
- WBC =3.000 µl
- Platelets =100.000 µl
- Adequate hepatic laboratory parameters:
- Total Bilirubin = 1,5 x ULN
- Alkaline phosphatase = 3 x ULN
- AST(GOT) < 2,5 ULN in patients without liver metastasis < 5 x ULN in patients
with liver metastasis ULN = (upper limit of normal)
- ALT(GPT) < 2,5 ULN in patients without liver metastasis < 5 x ULN in
patients with liver metastasis ULN = (upper limit of normal)
- Adequate renal laboratory parameters:
- Creatinine Clearance > 50 ml/min
- Urine dipstick for proteinuria < 2+ Patients discovered to have = 2+ proteinuria
on dipstick urinalysis at baseline should undergo a 24-hour urine collection and
must demonstrate <1 g of protein in 24 hours
- Normal cardiac function defined by New York Heart Association - NYHA Class I and
Class II
- Electrocardiogram without significant signs of cardiac arrhythmias
- Provision of informed consent according to local regulatory requirements prior to any
protocol specific treatment.
- Measurable lesion according to RECIST 1.1
- Negative pregnancy test for women of childbearing potential unless they are
postmenopausal at baseline. (Postmenopausal women must have been amenorrheic at least
for 12 months to be considered of non childbearing potential)
- Women of child bearing potential to be willing to use an acceptable method to avoid
pregnancy at least one month before study start. Examples: oral contraceptives (sole
application of oral contraceptives is not sufficient), diaphragm pessary,
intrauterine device (spiral), condom plus diaphragm pessary plus spermicide.
Exclusion Criteria:
- Histological confirmed predominant squamous cell carcinoma
- Presence of activating EGFR mutations in exons 18-21
- Pregnancy or lactation period
- Have known central nervous system (CNS) disease, other than stable, treated brain
metastasis. Stable, treated brain metastasis is defined as metastasis having no
evidence of progression or hemorrhage after treatment and no ongoing requirement for
dexamethasone, as ascertained by clinical examination and post-treatment brain
imaging (CT scan or magnetic resonance imaging [MRI]). Patients should be off
corticosteroids for 1 week (7 days) at the time of the post-treatment brain CT/MRI.
Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may
include whole brain radiotherapy, (stereotactic) radiosurgery (Gamma Knife, linear
particle accelerator, or equivalent), or a combination as deemed appropriate by the
treating physician, and must have been completed > 8 days prior to Day 1 of Cycle 1.
Patients with signs of a fresh bleeding into one or more cerebral metastases or with
CNS metastases treated by neurosurgical resection or brain biopsy performed within 8
weeks prior to Day 1 of Cycle 1 will be excluded.
- Evidence of tumor invading or abutting major blood vessels
- Presence of a tracheobronchial fistula
- History of abdominal fistula or fistulisation of urogenital tract, gastrointestinal
perforation or intra-abdominal abscess, inflammatory bowel disease, or diverticulitis
within 6 months prior to study start
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of a CIS of the cervix, non-melanomatous skin cancer, stable chronic
lymphatic leukaemia, non-muscle invasive bladder cancer or surgically treated or
irradiated prostate cancer with no signs of recurrence for one year. Patients with
other malignancies curatively treated and free of disease for at least 5 years will
be discussed with the Principal Investigator (LKP) before inclusion.
- Treatment with an investigational new drug, currently or within the last 28 days,
and/or participation in another clinical trial, currently or during the last 12
weeks, and/or previous participation in this study.
- History or presence of a mental disease or condition such as to interfere with the
patient's ability to understand the requirements of the study and the intake of study
medication according to study protocol.
- Patients with any clinically significant disease that in the opinion of the
investigator is likely to put the patient at risk or to interfere with the evaluation
of the patient's safety and of the study outcome. This includes, but is not limited
to:
- Immed",NULL,Progression free survival,Overall survival;Quality of life;Response rate;Molecular investigations,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-08-23,2012-08-23,0,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,NA,NA,TRUE,FALSE,TRUE
32816,NA,NA,EUCTR2010-022854-18,NCT: NA ICTRP: 2011-01-25 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,5,NA,NA,3,NA,"no AM, no metric",NCT: NA ICTRP: 20 DRKS: NA,NA,1,0,NA,NA,"neither open nor blinded according to register, but open-label according to title",NA,NA,NA,1,NA,kein Artikel,NA,NA,2012-11-12,NA,2011-11-30,2015-09-30,Interventional,Study of Frontline Dasatinib Plus Chemotherapy in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL),Open Label Phase II Study to Evaluate the Safety of Standard Induction and Consolidation Therapy in Combination With Dasatinib in Newly Diagnosed Adult Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL),Completed,Phase 2,19,Actual,Johann Wolfgang Goethe University Hospital,Treatment-related discontinuation of study treatment (Proportion of Patients),Molecular complete remission rate (CR);Hematologic complete remission rate;Grade III and IV txicity by Common Terminology Criteria for Adverse Events Version 3,2010-022854-18;GMALL-PH-01,Study of Frontline Dasatinib Plus Chemotherapy in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL),Open Label Phase II Study to Evaluate the Safety of Standard Induction and Consolidation Therapy in Combination With Dasatinib in Newly Diagnosed Adult Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PH+ALL),,,Interventional,"Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment",Phase 2,2012-02-03,2011-11-20,19,Completed,Johann Wolfgang Goethe University Hospitals,NULL,germany,Drug: Dasatinib,"
Inclusion Criteria:
- Confirmed new diagnosis of Philadelphia chromosome or BCR-ABL positive acute
lymphoblastic leukemia
- Male or female patients aged 18-55 years
- Not previously treated except for prephase (corticosteroids, cyclophosphamide, single
dose VCR will be permitted) therapy during establishment of the diagnosis
- Signed written inform consent, willingness and ability to comply with all study
procedures
- Molecular detection of BCR-ABL transcripts
- Willingness of women of child-bearing potential (WOCBP) and male subjects whose
sexual partners are WOCBP, to use an effective form of contraception (pearl index <
1%), such as complete sexual abstinence, combined oral contraceptive, hormone IUCD,
vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot
contraceptive injection in combination with a second method of contraception like a
condom or a cervical cap / diaphragm with spermicide or surgical sterilisation
(vasectomy) in male patients or male partners during the study and at least 6 months
thereafter. WOCBP are defined as sexually mature women who have not undergone a
hysterectomy or surgical sterilization or who have not been naturally postmenopausal
for at least 12 consecutive months (i.e., who has had menses any time in the
preceding 12 consecutive months).
- Negative pregnancy test for women of child-bearing potential.
Exclusion Criteria:
- Patients with ECOG status > 2
- Patients with QTcF > 470 ms
- Cardiac insufficiency NYHA grade III/IV, LEVF < 50%, myocardial infarction within the
past 6 months prior to study
- Active secondary malignancy requiring treatment
- Patients with active, uncontrolled bacterial, viral or fungal infection
- Known infection with HIV, Hepatitis B (except post vaccinal profile) or C
- Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional
upper limit of normal and total bilirubin > 2 fold the institutional upper limit
unless considered to be due to organ involvement by the leukemia
- Concurrent severe diseases which exclude the administration of therapy
- Expected non-compliance or inability to understand informed consent
- Female patients who are pregnant or breast feeding
- Treatment with other investigational antileukemic agents after informed consent.
",NULL,Treatment-related discontinuation of study treatment (Proportion of Patients),Molecular complete remission rate (CR);Hematologic complete remission rate;Grade III and IV txicity by Common Terminology Criteria for Adverse Events Version 3,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-11-30,2012-02-03,2012-02-03,19,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,TRUE,TRUE,NA,TRUE,2011,NA,TRUE,FALSE,TRUE
30783,NA,NA,EUCTR2006-004291-12,NCT: NA ICTRP: 2007-01-22 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,2,NA,"no AM, no time frame, no measure",2,NA,"no AM, no time frame, no measure",NCT: NA ICTRP: 664 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-05-03,NA,2006-10-04,2009-12-11,Interventional,PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD),A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD),Completed,Phase 3,535,Actual,Optimer Pharmaceuticals LLC,Cure Rate at End of Therapy,Recurrence;Global Cure,101.1.C.004;5119-019,PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD),A Double-Blind Study to Compare the Safety and Efficacy of PAR-101 to Vancomycin in Subjects With Clostridium Difficile-Associated Diarrhea (CDAD),;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2007-05-01,2006-10-04,535,Completed,Optimer Pharmaceuticals LLC,NULL,united states;belgium;canada;france;germany;italy;spain;sweden;united kingdom;belgium;canada;france;germany;italy;spain;sweden;united kingdom;united states;united states;belgium;canada;france;germany;italy;spain;sweden;united kingdom;belgium;canada;france;germany;italy;spain;sweden;united kingdom;united states;united states;belgium;canada;france;germany;italy;spain;sweden;united kingdom;belgium;canada;france;germany;italy;spain;sweden;united kingdom;united states;united states;belgium;canada;france;germany;italy;spain;sweden;united kingdom;belgium;canada;france;germany;italy;spain;sweden;united kingdom;united states;united states;belgium;canada;france;germany;italy;spain;sweden;united kingdom;belgium;canada;france;germany;italy;spain;sweden;united kingdom;united states,Drug: PAR-101/OPT-80;Drug: Vancomycin;Drug: PAR-101/OPT-80;Drug: Vancomycin;Drug: PAR-101/OPT-80;Drug: Vancomycin;Drug: PAR-101/OPT-80;Drug: Vancomycin,
Inclusion Criteria:
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Exclusion Criteria:
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
;
Inclusion Criteria:
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Exclusion Criteria:
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
;
Inclusion Criteria:
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Exclusion Criteria:
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
;
Inclusion Criteria:
- Males/females with CDAD
- Females must use adequate contraception
- Signed informed consent
Exclusion Criteria:
- Life-threatening CDAD
- Toxic megacolon
- Pregnant
- Concurrent use of diarrheal agents
- Participation in other trials
,NULL,Cure Rate at End of Therapy;Cure Rate at End of Therapy;Cure Rate at End of Therapy,Recurrence;Global Cure,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-10-04,2007-05-01,2007-05-01,535,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2006,NA,TRUE,FALSE,TRUE
30696,NA,NA,EUCTR2006-003284-31,NCT: NA ICTRP: 2006-10-24 DRKS: NA,0,NA,"Title indicates open study, but design section has ""open = no"". Also two intervention regimes but neither parallel nor crossover.",0,NA,NA,"""Seasonal prophylaxis of influenza in immunocompromised subjects"" as goal of trial, but no such inclusion criteria specified",2,NA,NA,2,NA,"no AM, no time frame, no measure",NA,NA,NA,NCT: NA ICTRP: 50 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-12-18,NA,2006-12-31,2007-05-31,Interventional,A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.,An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.,Completed,Phase 4,52,Actual,Hoffmann-La Roche,"AEs, laboratory parameters, vital signs.;Percentage of patients with laboratory confirmed clinical influenza",Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.,NV20236,A Study of Tamiflu (Oseltamivir) for Seasonal Prophylaxis of Influenza in Children.,An Open-label Multi-center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children.,,,Interventional,Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). ,Phase 4,2006-12-15,2006-12-20,52,Completed,Hoffmann-La Roche,NULL,united states;canada;denmark;canada;denmark;united states;germany,Drug: oseltamivir [Tamiflu],"
Inclusion Criteria:
- males or females, 1-12 years of age;
- candidate for seasonal prophylaxis;
- negative rapid diagnostic test for influenza at baseline.
Exclusion Criteria:
- symptoms suggestive of influenza-like illness;
- positive rapid diagnostic test for influenza;
- antiviral treatment for influenza in 2 weeks prior to randomization.
",NULL,"AEs, laboratory parameters, vital signs.;Percentage of patients with laboratory confirmed clinical influenza",Percentage of subjects with asymptomatic influenza; percentage with an influenza-like illness.,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-12-31,2006-12-15,2006-12-15,52,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2006,NA,TRUE,FALSE,TRUE
35354,NA,NA,EUCTR2017-000880-34,NCT: NA ICTRP: 2017-07-31 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no time frame, no measure",3,NA,"no time frame, no measure",NCT: NA ICTRP: 600 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-09-13,NA,2017-11-27,2020-03-26,Interventional,A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.,"An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients",Completed,Phase 2,606,Actual,GlaxoSmithKline,Rate of moderate and severe AECOPD (any cause)-analysis (87% CI);Rate of moderate and severe AECOPD (any cause) -Analysis (95% CI),"Number of subjects reporting each solicited local adverse event (AE).;Number of subjects reporting each solicited general AE.;Number of subjects reporting any unsolicited adverse event (AE).;Number of subjects reporting any potential immune-mediated diseases (pIMDs).;Number of subjects with serious adverse events (SAEs).;Rate of moderate and severe AECOPD in vaccinated and control subjects;Rate of all AECOPD cases in vaccinated and control subjects;Rate of all AECOPD cases, classified by severity.;Time to first moderate or severe AECOPD.;Time to first AECOPD of any severity.;Time to first AECOPD classified by severity.;Number of days with moderate and severe AECOPDs.;Number of days with AECOPDs of any severity.;Number of days with AECOPDs classified by severity.;Rate of Non-Typeable Haemophilus influenzae (NTHi)-associated and/ or Moraxella catarrhalis (Mcat)-associated moderate and severe AECOPD.;Rate of NTHi-associated and/ or Mcat-associated any severity AECOPD.;Rate of NTHi-associated and/ or Mcat-associated AECOPD cases, classified by severity.;Time to first moderate and severe NTHi-associated and/ or Mcat-associated AECOPD.;Time to first NTHi-associated and/or Mcat-associated AECOPD of any severity.;Time to first NTHi-associated and/or Mcat-associated AECOPD, classified by severity.;Number of days with moderate and severe NTHi-associated and Mcat-associated AECOPD.;Number of days with NTHi-associated and/or Mcat-associated AECOPDs of any severity.;Number of days with NTHi-associated and/or Mcat-associated AECOPD, classified by severity.;Anti-PD, anti-PE, anti-PilA and anti-UspA2 total Immunoglobulin G (IgG) antibody concentrations as measured by the Ezyme-Linked Immunosorbent Assay (ELISA,) in all subjects.;Frequency of specific cluster of differentiation (CD)4+ T-cells immune response for NTHi-specific and Mcat- specific measured by flow cytometry intracellular cytokine staining (ICS) in a sub-cohort of subjects.",2017-000880-34;207489,A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.,"An Observer-blind Study to Evaluate the Efficacy, Safety, Reactogenicity and Immunogenicity of the GSK Biologicals' Investigational Vaccine GSK3277511A When Administered to COPD Patients",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 2,2017-09-05,2017-11-27,606,Completed,GlaxoSmithKline,NULL,united states;belgium;canada;france;germany;italy;spain;united kingdom;belgium;canada;france;germany;italy;spain;united kingdom;united states,Biological: NTHi Mcat investigational vaccine (GSK3277511A);Biological: Placebo,"
Inclusion Criteria:
- Subjects who, in the opinion of the investigator, can and will comply with the
requirements of the protocol.
- Written informed consent obtained from the subject prior to performing any study
specific procedure.
- A male or female between, and including, 40 and 80 years of age at the time of the
first vaccination.
- Confirmed diagnosis of COPD with forced expiratory volume in 1 second (FEV1) over
forced vital capacity (FVC) ratio (FEV1/FVC) < 0.7, AND FEV1 < 80% predicted (GOLD 2,
3 and 4).
- Current or former smoker with a cigarette smoking history of = 10 pack-years.
- Stable COPD patient* with documented history** of at least 1 moderate or severe AECOPD
within the 12 months before Screening.
- Patient for whom the last episode of AECOPD is resolved for at least 30 days at
the time of first vaccination.
- A documented history of a COPD exacerbation is a medical record of worsening
COPD symptoms that required systemic/oral corticosteroids and/or antibiotics
(for a moderate exacerbation) or hospitalization (for a severe
exacerbation). Prior use of antibiotics alone does not qualify as an
exacerbation history unless the use was associated with treatment of
worsening symptoms of COPD, such as increased dyspnea, sputum volume, or
sputum purulence. Subject verbal reports are not acceptable.
- Capable of complying with the daily electronic Diary Card completion throughout the
study period, according to investigator's judgement at Visit 1.
- Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, current bilateral tubal
ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if the
subject:
has practiced adequate contraception for 30 days prior to vaccination, and has a negative
pregnancy test on the day of vaccination, and has agreed to continue adequate contraception
during the entire treatment period and for 2 months after completion of the vaccination
series.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine
during the period starting 30 days before the first dose of study vaccine (Day -29 to
Day 1), or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make
intramuscular injection unsafe.
- Administration of immunoglobulins or any blood products within the 3 months preceding
the first dose of study vaccine or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol
in the period starting 30 days before the first dose and ending 30 days after the last
dose of vaccine, with the exception of any influenza or pneumococcal vaccine which may
be administered =15 days preceding or following any study vaccine dose.
- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational vaccine/product.
- Chronic administration of immunosuppressants or other immune-modifying drugs during
the period starting six months prior to the first vaccine dose (e.g. methotrexate).
- Administration of systemic corticosteroids within the 30 days before first
vaccination.
Subjects who received systemic corticosteroids within this period may be enrolled at a
later date if enrolment is still open.
Inhaled and topical steroids are allowed.
• Administration of systemic antibiotics within the 30 days before first vaccination.
Subjects who received systemic antibiotics within this period may be enrolled at a later
date if enrolment is still open.
- Chronic use of antibiotics for prevention of AECOPD (e.g. azithromycin).
- Acute disease and/or fever at the time of first vaccination. Fever is defined as
temperature =37.5°C. The preferred location for measuring temperature in this study
will be the oral cavity or the axilla.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection)
without fever may be enrolled at the discretion of the investigator.
- Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen
therapy >3L/min (Oxygen use =3L/min flow is not exclusionary).
- Planned lung transplantation.
- Lung resection: Subjects with planned lung volume reduction surgery during the study
or within the 12 months prior to first vaccination.
- Diagnosis of a-1 antitrypsin deficiency as the underlying cause of COPD.
- Diagnosed with a respiratory disorder other than COPD at time of enrolment (such as
sarcoidosis, active tuberculosis, clinically significant bronchiectasis, clinically
significant lung fibrosis, clinically significant pulmonary embolism, clinically
significant pneumothorax, current diagnosis of asthma in the opinion of the
investigator), or chest X-ray/ CT scan revealing evidence of clinically significant
abnormalities not believed to be due to the presence of COPD. Subjects with allergic
rhinitis do not need to be excluded and may be enrolled at the discretion of the
investigator.
- History of immune-mediated disease other than COPD. If the subject has any condition
on the non-exhaustive list of potential immune-mediated diseases defined in the
protocol, they must be excluded unless the aetiology is clearly documented to be
non-immune mediated.
- Previous vaccination with any vaccine containing NTHi and/ or Mcat antigens.
- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccines and/ or the bronchodilator used for spirometry assessment during the
study.
- Contraindication for spirometry testing.
- Unstable or life threatening cardiac disease: subjects with any of the following at
Screening (Visit 1) would be excluded:
Myocardial infarction or unstable angina in the last 6 months. Unstable or life threatening
cardiac arrhythmia requiring intervention in the last 3 months NYHA Class IV Heart failure
- Malignancies within the previous 5 years or lymphoproli",NULL,Rate of moderate and severe AECOPD (any cause)-analysis (87% CI);Rate of moderate and severe AECOPD (any cause) -Analysis (95% CI),"Number of subjects reporting each solicited local adverse event (AE).;Number of subjects reporting each solicited general AE.;Number of subjects reporting any unsolicited adverse event (AE).;Number of subjects reporting any potential immune-mediated diseases (pIMDs).;Number of subjects with serious adverse events (SAEs).;Rate of moderate and severe AECOPD in vaccinated and control subjects;Rate of all AECOPD cases in vaccinated and control subjects;Rate of all AECOPD cases, classified by severity.;Time to first moderate or severe AECOPD.;Time to first AECOPD of any severity.;Time to first AECOPD classified by severity.;Number of days with moderate and severe AECOPDs.;Number of days with AECOPDs of any severity.;Number of days with AECOPDs classified by severity.;Rate of Non-Typeable Haemophilus influenzae (NTHi)-associated and/ or Moraxella catarrhalis (Mcat)-associated moderate and severe AECOPD.;Rate of NTHi-associated and/ or Mcat-associated any severity AECOPD.;Rate of NTHi-associated and/ or Mcat-associated AECOPD cases, classified by severity.;Time to first moderate and severe NTHi-associated and/ or Mcat-associated AECOPD.;Time to first NTHi-associated and/or Mcat-associated AECOPD of any severity.;Time to first NTHi-associated and/or Mcat-associated AECOPD, classified by severity.;Number of days with moderate and severe NTHi-associated and Mcat-associated AECOPD.;Number of days with NTHi-associated and/or Mcat-associated AECOPDs of any severity.;Number of days with NTHi-associated and/or Mcat-associated AECOPD, classified by severity.;Anti-PD, anti-PE, anti-PilA and anti-UspA2 total Immunoglobulin G (IgG) antibody concentrations as measured by the Ezyme-Linked Immunosorbent Assay (ELISA,) in all subjects.;Frequency of specific cluster of differentiation (CD)4+ T-cells immune response for NTHi-specific and Mcat- specific measured by flow cytometry intracellular cytokine staining (ICS) in a sub-cohort of subjects.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-11-27,2017-09-05,2017-09-05,606,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,NA,TRUE,FALSE,TRUE
33734,NA,NA,EUCTR2013-001193-14,NCT: NA ICTRP: 2013-09-06 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,no time interval between the 5 doses,3,NA,"no metric, no AM",3,NA,"no AM, no measure",NCT: NA ICTRP: 120 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2013-12-27,NA,2014-02-10,2015-09-23,Interventional,15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific),"A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific",Completed,Phase 2,121,Actual,Bayer,Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period,Change in local laboratory hemoglobin level from baseline;Speed of change in hemoglobin level per unit time;Duration of treatment exposure;Number of participants with serious adverse events as a measure of safety and tolerability;Pharmacodynamics characterized by erythropoietin concentration;Pharmacodynamics characterized by reticulocyte count,2013-001193-14;15141,15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific),"A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease Not Currently Treated With Erythropoiesis-stimulating Agent in Europe and Asia Pacific",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 2,2013-12-20,2014-02-10,121,Completed,Bayer,NULL,"australia;bulgaria;france;germany;hungary;israel;italy;japan;korea, republic of;poland;romania;spain;turkey;united kingdom;australia;bulgaria;france;germany;hungary;israel;italy;japan;korea, republic of;poland;romania;spain;turkey;united kingdom;united states",Drug: BAY85-3934;Drug: Placebo,"
Inclusion Criteria:
- Women without childbearing potential
- Male or female subjects = 18 years of age with anemia of chronic kidney disease (CKD)
at screening
- Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in
Renal Disease [MDRD] or the formula according to Matsuo, et al)
- Not on dialysis and not expected to begin dialysis during the treatment period of the
study (at least 16 weeks from randomization)
- Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before
randomization
- Mean screening Hb concentration
- Body weight of 45 kg to 125 kg, inclusive, at screening
Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal
bleeding
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus
erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
remission
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell
carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively
treated > 3 years prior to randomization
- Subjects treated with any ESA within the 8 weeks before randomization
- Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial
infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary
embolism) within the last 6 months from initial screening visit
- Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial flutter,
prolonged QT > 500 msec, third degree atrioventricular [AV] block)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT] or aspartate
aminotransferase [AST] > 3 x the upper limit of normal [ULN], total bilirubin > 2
mg/dL, or Child-Pugh B and C) or active hepatitis, in the investigator's opinion
",NULL,Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period,Change in local laboratory hemoglobin level from baseline;Speed of change in hemoglobin level per unit time;Duration of treatment exposure;Number of participants with serious adverse events as a measure of safety and tolerability;Pharmacodynamics characterized by erythropoietin concentration;Pharmacodynamics characterized by reticulocyte count,2013-001193-14; NCT02021370; 15141; 2013-001193-14,2015-02-17,no,"Anemia; Renal Insufficiency, Chronic; Chronic kidney disease; Other specified anaemias",Arm 1 Drug: BAY85-3934; Arm 2 Drug: Placebo,Interventional,Randomized controlled trial,Blinded,Placebo,Parallel,II,- Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period; time frame: Baseline and week 12 to 16
,- Change in local laboratory hemoglobin level from baseline; time frame: Baseline up to 12 weeks
- Speed of change in hemoglobin level per unit time; time frame: Up to 16 weeks
- Duration of treatment exposure; time frame: Up to 16 weeks
- Number of participants with serious adverse events as a measure of safety and tolerability; time frame: Up to 16 weeks
- Pharmacodynamics characterized by erythropoietin concentration; time frame: Several time points up to 16 weeks
- Pharmacodynamics characterized by reticulocyte count; time frame: Several time points up to 16 weeks
,"Australia; Bulgaria; France; Germany; Hungary; Italy; Japan; Korea, Republic of; Poland; Romania; Spain; United Kingdom",[---]* Pirmasens; [---]* Bonn; [---]* Düsseldorf; [---]* Berlin; [---]* Wuppertal,2014-02-27,NA,120,NA,"- Men who agree to use adequate contraception when sexually active or women without
childbearing potential
- Male or female subjects ≥ 18 years of age with anemia of chronic kidney disease (CKD)
at screening
- Estimated glomerular filtration rate of < 60 mL/min/1.73 m2 (Modification of Diet in
Renal Disease [MDRD] or the formula according to Matsuo, et al)
- Not on dialysis and not expected to begin dialysis during the treatment period of the
study (at least 16 weeks from randomization)
- Not treated with any erythropoiesis-stimulating agent (ESA) within 8 weeks before
randomization
- Mean screening Hb concentration < 10.0 g/dL
- Body weight of 45 kg to 125 kg, inclusive, at screening
","- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal
bleeding
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus
erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in
remission
- Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell
carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any cancer curatively
treated > 3 years prior to randomization
- Subjects treated with any ESA within the 8 weeks before randomization
- Red blood cell (RBC) containing transfusion within the 8 weeks before randomization
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial
infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary
embolism) within the last 6 months from initial screening visit
- Severe rhythm or conduction disorders (e.g., HR < 50 or > 110 bpm, atrial
fibrillation or flutter, prolonged QT > 500 msec, second or third degree
atrioventricular [AV] block)
- New York Heart Association Class III or IV congestive heart failure
- Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate
aminotransferase [AST], or gamma glutamyl transferase [GGT] > 3 x the upper limit of
normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B and C) or active hepatitis,
in the investigator's opinion
","A Randomized, Placebo-controlled, Double-blind, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of 5 Fixed Doses of BAY85-3934 Administered Orally in the Correction of Anemia in Erythropoiesis-stimulating Agent naïve, Pre Dialysis Subjects With Chronic Kidney Disease in Europe and Asia Pacific",Recruiting ongoing,Bayer; Bayer; [---]*,[---]*; [---]*; clinical-trials-contact@bayerhealthcare.com,Arm 1 Drug: BAY85-3934; Arm 2 Drug: Placebo,2014-02-10,2013-12-20,2013-12-20,121,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2014,NA,TRUE,TRUE,TRUE
28526,NA,NA,ISRCTN75334801,NCT: NA ICTRP: 2009-09-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM (prognostic relevance?),3,NA,"no AM, no time frame",NCT: NA ICTRP: 35 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NCT-2009-11-02-1031,In vivo response monitoring of treatment with the epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab in metastatic colorectal cancer,In vivo response monitoring of treatment with the epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab in metastatic colorectal cancer: a single centre phase II study ,,,Interventional,Prospective open-label single-arm single-centre early exploratory prognostic study (Treatment),NULL,2009-09-04,2010-01-01,35,Completed,University of Heidelberg (Germany),NULL,germany,"Treatment as well as routine and trial specific examinations will be conducted according to the following register:
Baseline: study registration followed by, for imaging analysis, fluorine-18 fluordeoxyglucose positron emission tomography (18F-FDG PET-CT) scan and contrast-enhanced ultrasound
Day 1: treatment with cetuximab 400 mg/m^2 body surface area (bsa) will be started
Day 8: treatment will be continued with cetuximab 250 mg/m^2 bsa
Day 14 (end of treatment): imaging analysis with 18F-FDG PET-CT and a contrast-enhanced ultrasound examination
Day 56: evaluation of clinical response with a routine CT-scan
Between day 14 and day 56, patients will be treated according to the Folfiri-cetuximab regimen as an active and approved first-line regimen for metastatic colorectal carcinoma.","Inclusion criteria: 1. Histologically confirmed metastatic colorectal cancer
2. KRAS-wildtype status of the tumour
3. No history of therapy with an EGFR targeting agent
4. No history of previous chemotherapy for advanced disease
5. Measurable tumour lesion with a diameter no smaller than 1.0 cm detected by computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound
6. For contrast-enhanced ultrasound: metastases no smaller than 2.0 cm detected by ultrasound
7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 or Karnofsky performance scale minimum 60%
8. Life expectancy greater than 12 weeks
9. Age greater than or equal to 18 years, either sex
10. Adequate haematologic, renal and hepatic function
11. Ability of the patient to understand the character and individual consequences of this clinical trial
12. Written informed consent (must be available before enrolment in the trial)
13. For women and men with childbearing potential adequate double barrier contraception, for women: negative pregnancy test
14. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures","Exclusion criteria: 1. Any contraindications for chemotherapy according to the Folfiri regimen
2. Non-curatively treated malignancy within the last 5 years
3. Uncontrolled or insulin-depending diabetes mellitus
4. Evidence of central nervous system (CNS) metastases
5. Uncontrolled infection
6. Significant cardiac disease (unstable angina pectoris or cardia symptoms according to New York Heart Association [NYHA] classification III or IV)
7. Active serious illness which renders the patient unsuitable for study entrance or multiple blood sampling
8. Pregnancy and lactation
9. History of hypersensitivity to cetuximab or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
10. Participation in other clinical trials or observation period of competing trials, respectively
11. No patient will be allowed to enrol in this trial more than once","To evaluate the prognostic relevance of relative changes in SUV (delta-SUV; as measured in 18F-FDG PET-CT at day 14 versus baseline) for early clinical response (as defined by Response Evaluation Criteria In Solid Tumours [RECIST], measured at day 56) during short-term single agent treatment with the EGFR-mAB cetuximab.","1. To investigate duration of PFS as well as the influence of changes in individual SUV and of early clinical response on PFS
2. To investigate duration of overall survival (OS)
3. The assessment of antivascular/antiangiogenic effects of cetuximab by contrast-enhanced ultrasound
This clinical trial will include an accompanying research component involving collection of biological samples for pseudonymised analyses. These will comprise sequential serum protein marker assessments (e.g., multiplex cytokine immune monitoring) as well as baseline analysis of tumour proteins and tumour genes, (e.g., PTEN expression, mutations in EGFR dependent downstream kinases like PI-3-kinase, BRAF and EGFR gene expression as measured by fluorescence-in-situ hybridisation). Patients may participate in this study even if they choose not to participate in this component.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-01-01,NA,2009-09-04,35,Interventional,TRUE,TRUE,NA,NA,TRUE,TRUE,FALSE,TRUE,NA,TRUE,2010,NA,TRUE,FALSE,FALSE
30434,NA,NA,EUCTR2006-000754-40,NCT: NA ICTRP: 2006-07-12 DRKS: NA,0,NA,"Not sure how crossover works. 3 interventions. Marked as controlled, but all interventions marked as test.",2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no time frame",2,NA,"no AM, no time frame, no measure",NCT: NA ICTRP: 15 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,TUD-CLOPIS-009,Interaktion von Statinen mit Clopidogrel als Sekundärprophylaxe bei der akuten zerebralen Ischämie - CLOPISTAT - CLOPISTAT,Interaktion von Statinen mit Clopidogrel als Sekundärprophylaxe bei der akuten zerebralen Ischämie - CLOPISTAT - CLOPISTAT ,,,Interventional,"Controlled: yesRandomised: yesOpen: noSingle blind: noDouble blind: yesParallel group: noCross over: yesOther: noIf controlled, specify comparator, Other Medicinial Product: yesPlacebo: noOther: no",NULL,2006-07-12,2007-02-28,15,Not Recruiting,Dresden University of Technology,NULL,germany,
Trade Name: Plavix
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Clopidogrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Locol
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fluvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Zocor
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Simvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
,"Inclusion criteria:
- Age 40 – 80 years
- TIA or first ischemic stroke
- NIHSS < 5
- Serumcholesterol > 5 mmol/l, Serum-LDL-C > 3 mmol/l
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
- Pre- treatment with ASS or other anticoagulant medication within the last 6 weeks
- Pre-treatment with lipid-lowering agents within the last 6 weeks
- Thrombolysis in acute stroke
- Previous stroke
- Malignant systemic disease
- Dementia
- Bathel-Index > 1
- Known liver damage or persistent ellevation of liver enzymes
- Known or current abuse of drugs, medications or alcohol
- Subjects unlikely to comply with the requirements of the protocol
- Pregnancy or lactation
- Women with child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they meet the following definition of post-menopausal: 12 month of natural (spontaneous) amenorrhea or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using a highly effective method of birth control (defined as those which result in a low failure rate, i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner
- Participation in another clinical trial within the last 4 weeks
","Main Objective: The main objective of the study is to demonstrate that fluvastatin 80 mg extended release (ER) has no effect on the inhibition of platelet aggregation by clopidogrel, where as atorvastatin reduces the anticoagulant effect of clopidogrel. The primary parameter will be ADP stimulated platelet aggregation.;Secondary Objective: - safety of the medication used in the trial
- lipid lowering potency of fluvastatin and simvastatin
- active metabolite of clopidogrel;Primary end point(s): Platelet aggregation after the treatment with the combination of clopidogrel / simvastatin and the combination of clopidogrel / fluvastatin.
",NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-02-28,NA,2006-07-12,15,Interventional,TRUE,TRUE,NA,NA,TRUE,TRUE,FALSE,TRUE,NA,TRUE,2007,NA,FALSE,FALSE,TRUE
35097,NA,NA,EUCTR2016-002920-10,NCT: NA ICTRP: 2016-08-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM (or no metric),NCT: NA ICTRP: 105 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-03-17,NA,2018-02-22,2021-12-31,Interventional,Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function,EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases,Recruiting,Phase 3,105,Anticipated,Ludwig-Maximilians - University of Munich,Change from Baseline Cerebrovascular Reactivity (CVR) at 4 weeks of Monotherapy,Change from Baseline Mean Systolic Blood Pressure (SBP) at the last week of each treatment phase;Change from Baseline Blood Pressure Variability (BPv) at the last week of each treatment phase,TRE-1486--0105-I,Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function,EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases,;;;;;anna.kopczak@med.uni-muenchen.de,;;;;;anna.kopczak@med.uni-muenchen.de,Interventional,Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). ,Phase 3,2017-03-08,2018-02-22,105,Recruiting,Ludwig-Maximilians - University of Munich,University of Edinburgh;Maastricht University Medical Center;UMC Utrecht;University of Oxford,germany;netherlands;united kingdom;germany;netherlands;united kingdom,Drug: Amlodipine;Drug: Losartan;Drug: Atenolol,"
Inclusion Criteria:
Patients may be enrolled in the trial if all of the following criteria have been met:
- Symptomatic SVD defined as
- History of clinical lacunar stroke in the last 5 years with a corresponding small
subcortical infarct visible on MRI scan or CT scan* compatible with the clinical
syndrome.
*On MRI, recent infarct is defined as a diffusion-weighted imaging (DWI) lesion
on the acute MRI scan. On CT, recent infarct is defined as a novel infarct on CT
within 3 weeks after the event that was not visible on the admission CT. Patients
admitted to the hospital with an obvious lacunar syndrome and an admission CT/CT
perfusion compatible with a lacunar infarct but without an MRI in the (sub)acute
stage and no repeat CT performed in the context of clinical care can be recruited
for TREAT-SVDs. After providing informed consent they will be invited for the
screening visit including a 3T MRI. The 3T MRI will be used to verify the
presence of a new lesion, relative to the admission CT, compatible with a lacunar
infarct and compatible with the lacunar syndrome. If such a lesion is present the
patient will undergo the further TREAT-SVDs workup. If no such lesion is observed
the patient will be excluded from the study and considered as a screening
failure.
- or cognitive impairment defined as visiting a memory clinic with cognitive
complaints, objective cognitive impairment*, and capacity to consent, and with
confluent deep white matter hyperintensities (WMH) on MRI (defined on the Fazekas
scale as deep WMH score = 2)
*concluded by the treating physician based on a validated cognitive measurement
tool (for example but not limited to MoCA or CAMCOG)
- or a diagnosis of CADASIL established by molecular genetic testing of the NOTCH3
gene (presence of an archetypical, cysteine-affecting mutation) or the presence
of granular osmiophilic material in ultrastructural, electron microscopy analysis
of skin biopsy
- Indication for antihypertensive treatment (as defined by meeting one of the
following):
- Hypertension defined as SBP = 140 mmHg or diastolic BP (DBP) = 90 mmHg without
antihypertensive treatment or use of an antihypertensive drug for previously
diagnosed hypertension
- Prior history of stroke or transient ischaemic attack (TIA)
- Age 18 years or older
- Written informed consent
Exclusion Criteria:
Patients will be excluded from the trial for any of the following reasons:
- Inclusion criteria are not met
- Unwillingness or inability to give written consent
- Pregnant or breastfeeding women, women of childbearing age not taking contraception.
Acceptable contraception in women of childbearing age is a highly effective contraceptive
measure as defined by the Clinical Trials Facilitation Group and includes combined
(oestrogen and progesterone containing) or progesterone-only contraception associated with
inhibition of ovulation, or intrauterine device, or bilateral tubal occlusion.
- Contraindications to MRI (pacemaker, aneurysm clip, cochlear implant etc.)
- Other major neurological or psychiatric conditions affecting the brain and interfering
with the trial design (e.g. multiple sclerosis)
- In case of clinical lacunar stroke syndrome other causes of stroke such as
- = 50% luminal stenosis (NASCET) in large arteries supplying the area of ischaemia
- major-risk cardioembolic source of embolism (permanent or paroxysmal atrial
fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac
valve, atrial myxoma or other cardiac tumours, mitral stenosis, recent (< 4
weeks) myocardial infarction, left ventricular ejection fraction less than 30%,
valvular vegetations, or infective endocarditis)
- other specific causes of stroke identified (e.g. arteritis, dissection,
migraine/vasospasm, drug misuse)
- Other stroke risk factor requiring immediate intervention that would preclude
involvement in the trial
- Renal impairment (eGFR < 35ml/min)
- Life expectancy < 2 years
- Use of > 2 antihypertensive drugs at maximum dose or equivalent (one drug at the
maximum dose and two drugs at half of the maximum dose) for an appropriate BP control
- Contraindications to the applied antihypertensive drugs as known
- Severe aortic stenosis
- Bilateral renal artery stenosis
- Severe arterial circulatory disorders
- Atrioventricular block II° or III° or sick sinus syndrome
- Heart failure (NYHA III or IV)
- Bradycardia, resting heart rate < 50/min
- Bronchospastic diseases such as severe bronchial asthma
- Severe hepatic dysfunction such as liver cirrhosis
- Use of monoamine oxidase (MAO)-A-blockers
- Use of simvastatin > 20mg/d
- Metabolic acidosis
- Disturbed electrolyte homeostasis such as hypercalcaemia, hypokalaemia, and
hyponatraemia
- Symptomatic hyperuricaemia (gout)
",NULL,Change from Baseline Cerebrovascular Reactivity (CVR) at 4 weeks of Monotherapy,Change from Baseline Mean Systolic Blood Pressure (SBP) at the last week of each treatment phase;Change from Baseline Blood Pressure Variability (BPv) at the last week of each treatment phase,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-02-22,2017-03-08,2017-03-08,105,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,NA,TRUE,FALSE,TRUE
35042,NA,NA,EUCTR2016-002368-15,NCT: NA ICTRP: 2016-08-22 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,"no AM, no measure",5,NA,NA,5,NA,NA,NCT: NA ICTRP: 45 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-01-19,NA,2016-12-31,2017-12-31,Interventional,"A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis","A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis",Completed,Phase 2,49,Actual,UCB Pharma,Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28;Mean plasma concentration of bimekizumab at Week 16;Number of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab;Incidence of adverse events (AEs),Number of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16;Number of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16;Number of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16;Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16,2016-002368-15;PS0016,"A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis","A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2017-01-17,2016-12-20,49,Completed,UCB Biopharma S.P.R.L.,Parexel,"united states;australia;canada;moldova, republic of;australia;canada;moldova, republic of;united states;germany",Drug: Bimekizumab;Other: Placebo,"
Inclusion Criteria:
- Male or female at least 18 years of age and less than or equal to 70
- Chronic plaque psoriasis for at least 6 months prior to Screening
- Psoriasis Area and Severity Index (PASI) >=12 and body surface area (BSA) >=10% and
Investigator's Global Assessment (IGA) score >=3 on a 5-point scale
- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
potential, must be willing to use a highly effective method of contraception up till
20 weeks after last administration of study drug, and have a negative pregnancy test
at Visit 1 (Screening) and immediately prior to first dose
- Male subjects with a partner of childbearing potential must be willing to use a condom
when sexually active, up till 20 weeks after the last administration of study
medication (anticipated 5 half-lives)
Exclusion Criteria:
- Subjects previously participating in a bimekizumab study
- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced
psoriasis
- History of chronic or recurrent infections, or a serious or life-threatening infection
within the 6 months prior to the Baseline Visit (including herpes zoster)
- High risk of infection in the Investigator's opinion
- Current sign or symptom that may indicate an active infection
- Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus
(HIV) infection
- Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- Subjects with concurrent malignancy or history of malignancy during the past 5 years
(except for specific malignant condition as defined in the protocol)
- Primary immunosuppressive conditions
- TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or
current or history of NTMB infection
- Laboratory abnormalities, as defined in the study protocol
- Any condition which, in the Investigator's judgement, would make the subject
unsuitable for inclusion in the study
- Exposure to more than 1 biological response modifier (limited to anti-TNF or
IL-12/-23) or any biologic response modifier during the three months prior to the
Baseline Visit
- Subjects have received previous treatment with any anti-IL-17 therapy for the
treatment of psoriasis or psoriatic arthritis
- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic
arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic
lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative
colitis are allowed as long as they have no active symptomatic disease at Screening or
Baseline
- Subjects taking psoriatic arthritis medications other than nonsteroidal
anti-inflammatory drugs (NSAIDs) or analgesics
",NULL,Change from Baseline in Psoriasis Area and Severity Index (PASI) at Week 28;Mean plasma concentration of bimekizumab at Week 16;Number of participants reporting positive Anti-Drug-Antibodies (ADA) titre prior to and following study treatment with bimekizumab;Incidence of adverse events (AEs),Number of subjects achieving a 75% or higher improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16;Number of subjects achieving a 90% or higher improvement in PASI (Psoriasis Area and Severity Index) score at Week 16;Number of subjects achieving a 100% improvement from Baseline in PASI (Psoriasis Area and Severity Index) score at Week 16;Percentage of subjects with IGA (Investigator´s Global Assessment) response at Week 16,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-12-31,2017-01-17,2017-01-17,49,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2016,NA,TRUE,FALSE,TRUE
31316,NA,NA,EUCTR2007-003780-50,NCT: NA ICTRP: 2008-01-07 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no measure,NCT: NA ICTRP: 502 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,Outcome missing,kein Artikel,NA,NA,2007-12-17,NA,2008-02-05,2015-05-27,Interventional,Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML,"A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA",Completed,Phase 3,502,Actual,Pfizer,Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1,Percentage of Participants With Major Molecular Response (MMR) at Year 1;Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks;Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks;Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks;Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks,B1871008;2007-003780-50;3160A4-3000,Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML,"A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2007-12-13,2008-02-05,502,Completed,Pfizer,Wyeth is now a wholly owned subsidiary of Pfizer,"united states;argentina;belgium;brazil;canada;chile;china;colombia;france;germany;hong kong;hungary;india;italy;japan;korea, republic of;latvia;lithuania;mexico;poland;russian federation;singapore;south africa;spain;taiwan;thailand;turkey;ukraine;united kingdom;argentina;belgium;brazil;canada;chile;china;colombia;france;germany;hong kong;hungary;india;italy;japan;korea, republic of;latvia;lithuania;mexico;poland;russian federation;singapore;south africa;spain;taiwan;thailand;turkey;ukraine;united kingdom;united states;croatia;puerto rico;slovenia",Drug: Bosutinib;Drug: imatinib,
Inclusion Criteria:
- Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.
- Diagnosis of CML chronic phase confirmed.
- Adequate hepatic and renal function.
- Able to take oral tablets.
Exclusion Criteria:
- Exclusions include Philadelphia negative CML.
- Prior anti-leukemia treatment.
- Prior stem cell transplant.
,NULL,Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1,Percentage of Participants With Major Molecular Response (MMR) at Year 1;Kaplan-Meier Estimate of Probability of Retaining CCyR at 192 Weeks;Kaplan-Meier Estimate of Probability of Retaining Complete Hematologic Response (CHR) at 192 Weeks;Kaplan-Meier Estimate of Probability of Retaining Derived MMR at 144 Weeks;Cumulative Incidence of On-Treatment Transformation to Accelerated Phase (AP) or Blast Phase (BP) at 192 Weeks,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-02-05,2007-12-13,2007-12-13,502,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2008,NA,TRUE,FALSE,TRUE
31072,NA,NA,EUCTR2007-000828-40,NCT: NA ICTRP: 2007-12-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,3,NA,"no metric, no AM",NCT: NA ICTRP: 170 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2008-05-07,NA,2008-06-30,2010-12-31,Interventional,Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study,"A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis",Completed,Phase 3,194,Actual,UCB Pharma,Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24,28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24;Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24;Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits;Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits;Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits;American College of Rheumatology 20% (ACR20) Response at Week 24;American College of Rheumatology 50% (ACR50) Response at Week 24;American College of Rheumatology 70% (ACR70) Response at Week 24;Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24;Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24;Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24;Change From Baseline in Fatigue Assessment Scale at Week 24,2007-000828-40;C87076,Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study,"A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis",;;;,;;;,Interventional,,Phase 3,2008-05-05,2008-06-20,194,Completed,UCB Pharma,NULL,austria;france;germany;italy;poland;austria;france;germany;italy;poland;austria;france;germany;italy;poland;austria;france;germany;italy;poland;austria;france;germany;italy;poland;austria;france;germany;italy;poland;austria;france;germany;italy;poland;austria;france;germany;italy;poland,Biological: Certolizumab pegol;Biological: Placebo;Biological: Certolizumab pegol;Biological: Placebo;Biological: Certolizumab pegol;Biological: Placebo;Biological: Certolizumab pegol;Biological: Placebo,"
Inclusion Criteria:
- Patients with established diagnosis of low to moderate adult rheumatoid arthritis,
currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six
months and not longer than 10 years
Exclusion Criteria:
- All the concomitant diseases or pathological conditions that could interfere and
impact the assessment of the study treatment, or with the safety of the patient
- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trial
- Patients must not have received any previous biological therapy for rheumatoid
arthritis (RA)
;
Inclusion Criteria:
- Patients with established diagnosis of low to moderate adult rheumatoid arthritis,
currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six
months and not longer than 10 years
Exclusion Criteria:
- All the concomitant diseases or pathological conditions that could interfere and
impact the assessment of the study treatment, or with the safety of the patient
- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trial
- Patients must not have received any previous biological therapy for rheumatoid
arthritis (RA)
;
Inclusion Criteria:
- Patients with established diagnosis of low to moderate adult rheumatoid arthritis,
currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six
months and not longer than 10 years
Exclusion Criteria:
- All the concomitant diseases or pathological conditions that could interfere and
impact the assessment of the study treatment, or with the safety of the patient
- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trial
- Patients must not have received any previous biological therapy for rheumatoid
arthritis (RA)
;
Inclusion Criteria:
- Patients with established diagnosis of low to moderate adult rheumatoid arthritis,
currently on Disease Modifying AntiRheumatic Drugs (DMARDs) therapy for at least six
months and not longer than 10 years
Exclusion Criteria:
- All the concomitant diseases or pathological conditions that could interfere and
impact the assessment of the study treatment, or with the safety of the patient
- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trial
- Patients must not have received any previous biological therapy for rheumatoid
arthritis (RA)
",NULL,Clinical Disease Activity Index (CDAI) Remission (=2.8) at Both Week 20 and Week 24;Clinical Disease Activity Index (CDAI) Remission (=2.8) at Both Week 20 and Week 24,28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24;Simplified Disease Activity Index (SDAI) Remission (=3.3) at Both Week 20 and Week 24;Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits;Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits;Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits;American College of Rheumatology 20% (ACR20) Response at Week 24;American College of Rheumatology 50% (ACR50) Response at Week 24;American College of Rheumatology 70% (ACR70) Response at Week 24;Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24;Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24;Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24;Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24;Change From Baseline in Fatigue Assessment Scale at Week 24,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-06-30,2008-05-05,2008-05-05,194,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2008,NA,TRUE,FALSE,TRUE
33914,NA,NA,EUCTR2013-003752-21,NCT: NA ICTRP: 2013-10-15 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,2,NA,"no AM, no measure, no time frame",3,NA,"no AM, no time frame (""selected time points"")",NCT: NA ICTRP: 70 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2014-01-07,NA,2014-02-20,2022-03-25,Interventional,Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD),"A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)","Active, not recruiting",Phase 3,83,Actual,Hoffmann-La Roche,Time to First Protocol-Defined Relapse (TFR) in the Double-Blind Period,Change From Baseline at Week 24 in the Visual Analogue Scale (VAS) Score for Pain;Change From Baseline at Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score;Relapse-Free Rate During the DB Period;Annualized Relapse Rate (ARR) During the DB Period;Change From Baseline in Modified Rankin Scale (mRS) Scores at 24 Week Intervals During the DB Period;Change From Baseline in Zarit Burden Interview (ZBI) Scores at 24 Week Intervals During the DB Period;Change From Baseline in Expanded Disability Status Scale (EDSS) Scores at 24 Week Intervals During the DB Period;Change From Baseline in Visual Acuity (Snellen Chart) at 24 Week Intervals During the DB Period;Change From Baseline in Short Form Generic Health Survey (SF-36) Mental Component Summary Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Physical Component Summary Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Bodily Pain Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 General Health Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Mental Health Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Physical Functioning Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Role-Emotional Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Role-Physical Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Social Role Functioning Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in SF-36 Vitality Domain Scores at 24 Week Intervals During the DB Period;Change From Baseline in EuroQoL-5 Dimensions (EQ-5D) Index Scores at 24 Week Intervals During the DB Period;Serum Satralizumab Concentration During the DB Period;Serum Soluble IL-6 Receptor (sIL-6R) Concentration During the DB Period;Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration During the DB Period;Serum Interleukin-6 (IL-6) Concentration During the DB Period;Number of Participants With at Least One Adverse Event in the DB Period;Number of Participants With at Least One Serious Adverse Event in the DB Period;Number of Participants With Non-Serious Adverse Events of Special Interest in the DB Period;Number of Participants With Selected Adverse Events in the DB Period;Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia-Suicide Severity Rating Scale in the DB Period;Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time;Percentage of Blood Plasmablast Over Time;Percentage of Participants With Anti-Drug Antibodies to Satralizumab in the DB Period,2013-003752-21;SA-307JG;BN40898,Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD),"A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2014-01-06,2014-02-20,83,"Active, not recruiting",Hoffmann-La Roche,Chugai Pharmaceutical,united states;france;germany;hungary;italy;japan;poland;spain;taiwan;ukraine;united kingdom;france;germany;hungary;italy;japan;poland;spain;taiwan;ukraine;united kingdom;united states,Drug: Satralizumab;Drug: Placebo;Drug: Baseline Treatment,"
Inclusion Criteria:
1. Patients must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum
disorder (NMOSD), defined as the following:
1. NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following
3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three
supportive criteria: Contiguous spinal cord lesion identified on a magnetic
resonance imaging (MRI) scan extending over 3 vertebral segments; Brain MRI not
meeting diagnostic criteria for multiple sclerosis (MS); NMO-IgG seropositive
status)
2. NMOSD as defined by either of the following Wingerchuk 2007 criteria with
anti-AQP4 antibody (Ab) seropositive status at screening (i. Idiopathic single or
recurrent events of longitudinally extensive myelitis [=3 vertebral segment
spinal cord MRI lesion]; ii. Optic neuritis: recurrent or simultaneous
bilateral); For patients aged 12 to 17 years, a minimum of 4 patients should be
positive for anti-AQP4Ab status at screening
2. Clinical evidence of at least 2 documented relapses (including first attack) in the
last 2 years prior to screening, at least one of which has occurred in the 12 months
prior to screening
3. EDSS score from 0 to 6.5 inclusive at screening
4. Age 12 to 74 years, inclusive at the time of informed consent
5. One of the following baseline treatments must be at stable dose as a monotherapy for 8
weeks prior to baseline: Azathioprine; Mycophenolate mofetil; Oral corticosteroids.
For participants aged 12 to 17 years, either of the following baseline treatments for
relapse prevention can be allowed: Azathioprine + oral corticosteroids; Mycophenolate
mofetil + oral corticosteroids
6. Ability and willingness to provide written informed consent and to comply with the
requirements of the protocol
For adolescents who may be enrolled after the end of the double-blind period, the inclusion
criterion 2 is as follows (other criteria are same): Clinical evidence of at least 2
documented relapses (including first attack) prior to screening.
Exclusion Criteria:
Exclusion criteria related to previous or concomitant therapy:
1. Any previous treatment with IL-6 inhibitory therapy (e.g. tocilizumab), alemtuzumab,
total body irradiation or bone marrow transplantation at any time
2. Any previous treatment with anti-CD20, eculizumab, belimumab, interferon, natalizumab,
glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months
prior to baseline
3. Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior
to baseline
4. Treatment with any investigational agent within 3 months prior to baseline
Exclusions for general safety:
5. Pregnancy or lactation
6. For patients of reproductive potential, a positive result from a serum pregnancy test
at screening, or not willing to use reliable means of contraception (physical barrier
[patient or partner] in conjunction with a spermicidal product, contraceptive pill,
patch, injectables, intrauterine device or intrauterine system) during the treatment
period and for at least 3 months after the last dose of study drug
7. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
8. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy
(PML)
9. Evidence of serious uncontrolled concomitant diseases that may preclude patient
participation, such as: other nervous system disease, cardiovascular disease,
hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine
disease, renal/urologic disease, digestive system disease, congenital or acquired
severe immunodeficiency
10. Known active infection (excluding fungal infections of nail beds or caries dentium)
within 4 weeks prior to baseline
11. Evidence of chronic active hepatitis B or C
12. History of drug or alcohol abuse within 1 year prior to baseline
13. History of diverticulitis that, in the Investigator's opinion, may lead to increased
risk of complications such as lower gastrointestinal perforation
14. Evidence of active tuberculosis (TB; excluding patients receiving chemoprophylaxis for
latent TB infection)
15. Evidence of active interstitial lung disease
16. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline
17. History of malignancy within the last 5 years, including solid tumors, hematologic
malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of
the skin, or in situ carcinoma of the cervix uteri that have been completely excised
and cured)
18. History of severe allergic reaction to a biologic agent (e.g. shock, anaphylactic
reactions)
19. Active suicidal ideation within 6 months prior to screening, or history of suicide
attempt within 3 years prior to screening
20. Following laboratory abnormalities at screening*.
1. White blood cells (WBC) <3.0 x10^3/microliter (µL)
2. Absolute neutrophil count (ANC) <2.0 x10^3/µL
3. Absolute lymphocyte count <0.5 x10^3/µL
4. Platelet count <10 x 10^4/µL
5. Aspartate aminotransferase (AST) or alanine aminotranferase (ALT) >1.5 times the
upper limit of normal (ULN) * If retest is conducted, the last value of retest
before randomization must meet study criteria.
For adolescents who may be enrolled after the end of the double-blind period, the
annotation in the exclusion criterion 20 is as follows (other criteria are same): * If
retest is conducted, the last value of retest before baseline must meet study criteria
",NULL,Time to First Protocol-Defined Relapse in the Double-Blind Period,Change from Baseline to Week 24 in the Visual Analogue Scale (VAS) Score for Pain;Change from Baseline to Week 24 in the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score;Change from Baseline Over Time in the Short Form Generic Health Survey (SF-36) Bodily Pain Domain Score;Change from Baseline Over Time in the SF-36 General Health Domain Score;Change from Baseline Over Time in the SF-36 Mental Health Domain Score;Change from Baseline Over Time in the SF-36 Physical Functioning Domain Score;Change from Baseline Over Time in the SF-36 Role-Emotional Domain Score;Change from Baseline Over Time in the SF-36 Role-Physical Domain Score;Change from Baseline Over Time in the SF-36 Social Role Functioning Domain Score;Change from Baseline Over Time in the SF-36 Vitality Domain Score;Change from Baseline Over Time in the SF-36 Mental Component Summary Score;Change from Baseline Over Time in the SF-36 Physical Component Summary Score;Change from Baseline Over Time in the EuroQoL-5 Dimensions (EQ-5D) Index Score;Percentage of Participants Who Are Relapse-Free Over Time;Annualized Relapse Rate;Change from Baseline Over Time in Modified Rankin Scale (mRS) Score;Change from Baseline Over Time in Zarit Burden Interview (ZBI) Score;Change from Baseline Over Time in Expanded Disability Status Scale (EDSS) Score;Change from Baseline Over Time in Visual Acuity (Snellen Chart);Number of Participants with at Least One Adverse Event by Severity;Number of Participants with at Least One Serious Adverse Event by Severity;Number of Participants with Non-Serious Adverse Events of Special Interest by Severity;Number of Participants with Selected Adverse Events by Severity;Number of Participants by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores;Serum Satralizumab Concentration Over Time;Serum Interleukin-6 (IL-6) Concentration Over Time;Serum Soluble IL-6 Receptor (sIL-6R) Concentration Over Time;Serum High Sensitivity C-Reactive Protein (hsCRP) Concentration Over Time;Blood Anti-Aquaporin-4 (AQP4) Antibody Concentration Over Time;Blood Plasmablast Concentration Over Time;Number of Participants with Anti-Drug Antibodies to Satralizumab,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-02-20,2014-01-06,2014-01-06,83,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2014,NA,TRUE,FALSE,TRUE
33981,NA,NA,EUCTR2013-004812-24,NCT: NA ICTRP: 2014-08-26 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,"""Progression free survival""",NCT: NA ICTRP: 172 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,No outcome,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,INCB39110-203;2013-004812-24-IE,A Phase 2 Study of INCB039110 in combination with docetaxel in advanced Non–Small Cell Lung Cancer,"A Randomized, Phase 2 Study of INCB039110 or Placebo in Combination With Docetaxel in Subjects With Previously Treated Stage IIIb, IV, or Recurrent Non–Small Cell Lung Cancer - INCB39110 with docetaxel in NSCLC ",RegAffairs@incyte.com,RegAffairs@incyte.com,Interventional,"Controlled: yesRandomised: yesOpen: noSingle blind: noDouble blind: yesParallel group: yesCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: noPlacebo: yesOther: noNumber of treatment arms in the trial: 2",Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no,2014-09-05,2014-12-12,172,Not Recruiting,Incyte Corporation,NULL,"france;united states;hungary;hong kong;european union;canada;spain;ireland;australia;germany;united kingdom;korea, republic of",
Product Code: INCB039110
Pharmaceutical Form: Tablet
Current Sponsor code: INCB039110
Other descriptive name: INCB039110
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
,"Inclusion criteria:
- Male or female, 18 years or older.
- Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV or recurrent.
- mGPS of 1 or 2 as defined below:
- mGPS of 1: C-reactive protein (CRP) > 10 mg/L and albumin = 35 g/L
- mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L.
- Radiographically measurable or evaluable disease.
- Measurable lesions may be in the field of prior radiation; however, there must be at least a 4-week period between the last radiation treatment and demonstration of interval progression of the lesion compared with the baseline scan documenting disease status for the lesion to be considered measurable.
- Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease (not including neoadjuvant and/or adjuvant therapy except as noted below).
- Prior systemic regimens must include a platinum based therapy. Investigational agents used in combination with standard platinum therapies are allowed.
- Tumors with driver mutations (EGFR mutation positive or ALK fusion oncogene positive) are allowed provided they also had prior treatment with a tyrosine kinase inhibitor (TKI).
- Maintenance therapy after first-line chemotherapy is allowed provided that the maintenance therapy did not include docetaxel or other taxane.
- Subjects who completed a platinum-containing regimen as adjuvant, neoadjuvant, or part of a course of chemoradiation therapy within the 6 months before screening are allowed.
- Prior treatment of advanced or metastatic disease with immune targeted therapy is allowed.
= 3 weeks or 5 half-lives (whichever is longer) have elapsed from the completion of previous systemic therapy regimen (including maintenance therapy or immunotherapy) prior to the initiation of therapy and subjects must have recovered or be at a new stable baseline from any related toxicities prior to dosing.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
","Exclusion criteria:
1. Received prior treatment with a taxane.
2. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
3. Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
a. No evidence of new or enlarging CNS metastasis or new neurological symptoms
attributable to CNS metastases.
b. Asymptomatic and off all corticosteroids and anticonvulsants for at least 1 month prior to study entry.
4. Peripheral neuropathy = Grade 3.
5. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy.
6. Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit. If the subject has any of the following, they are excluded:
a. ANC < 1.5 × 109/L.
b. Platelet count < 100 × 109/L.
c. Hemoglobin < 9 g/L (transfusion are permitted to achieve baseline hemoglobin level.)
d. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2.5 × the upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
e. Alkaline phosphatase (ALP) > 2.5 × ULN.
f. Subjects with ALT or AST elevation > ULN and ALP > ULN.
g. Total bilirubin > ULN.
h. Creatinine clearance < 50 mL/min measured or calculated by Cockroft-Gault equation or GFR < 50 mL/min/1.73 m2 as calculated using modification of diet in renal disease (MDRD).
7. Significant, concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
8. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization).
9. Concurrent therapy with a potent CYP3A4 inducer or inhibitor. Subjects may enter screening when therapy with the potent inhibitor or inducer is completed and may begin study treatment after 1 week or 5 half-lives, whichever is longer.
10. Subjects who participated in any other study in which receipt of an investigational study drug occurred within 28 days before first dose of study treatment.
11. Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
12. Known HIV infection, or HBV or HCV viremia or at risk for HBV reactivation. HBV DNA and HCV RNA must be undetectable. At risk for HBV reactivation is defined as HBSAg positive or anti-HBc antibody positive.
13. Pregnant or actively breastfeeding women.
14. Unwilling to be transfused with blood components.
15. Known hypersensitivity to any of the active substances or any of their excipients, including a JAK inhibitor or docetaxel.
","Main Objective: Safety Run-In Phase (Part 1):
• To evaluate the safety and tolerability of INCB039110 in combination with docetaxel and select their doses for further evaluation.
Randomized Phase (Part 2):
• To evaluate and compare the OS of subjects with previously treated advanced or metastatic NSCLC when treated with INCB039110 in combination with docetaxel versus docetaxel alone.
;Secondary Objective: •To evaluate and compare the efficacy of the 2 treatment groups with respect to PFS.
•To evaluate and compare the efficacy of the 2 treatment groups with respect to overall tumor response and duration of response.
•To evaluate and compare disease control of INCB039110 in combination with docetaxel versus INCB039110 alone.
•To evaluate and compare the safety and tolerability of INCB039110 in combination with docetaxel versus docetaxel alone.
;Primary end point(s): Safety run-in Phase (Part 1):
- Safety and tolerability of the treatment regimens through assessment of AEs and changes in safety assessments including laboratory parameters.
- Determination of a MTD (MTD is defined as the highest dose level tested that is considered tolerated on the basis of fewer than 3 DLTs in a cohort of up to 9 subjects) of INCB039110 in combination with docetaxel.
Randomized Phase (Part 2)
- Overall survival determined from the date of randomization until death due to any cause.;Timepoint(s) of evaluation of this end point: The primary endpoint is OS, defined as number of days from randomization to death.
Once a total of 69 events has been observed, which is expected after an enrollment period of 12 months, and 5 months of follow-up after the last subject is randomized.
","Secondary end point(s): •Progression-free survival defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause, if sooner.
•Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment.
•Safety and tolerability through assessment of AEs and changes in safety assessments and laboratory parameters.
•Disease control as measured by the percentage of patients whose best response was not progressive disease (PD) (ie, complete response [CR], partial response [PR], or stable disease [SD] per RECIST v1.1). Stable disease will be included if it occurs at least 6 weeks after randomization.
;Timepoint(s) of evaluation of this end point: Secondary efficacy analysis will be conducted for the intent-to-treat population.
Progression-free survival will be determined from the randomization date until the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death due to any cause if earlier.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-12-12,NA,2014-09-05,172,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2014,NA,FALSE,FALSE,TRUE
29667,NA,NA,EUCTR2004-004881-34,NCT: NA ICTRP: 2005-02-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,3 points but no time frame or intervals. Does clinicaltrialsregister.eu offter that info?,4,NA,no AM,NA,NA,NA,NCT: NA ICTRP: 264 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2005-11-22,NA,2005-03-31,2006-06-30,Interventional,Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20 mg) Multicenter Study of Long-Term Glycemic Control With Rimonabant in Treatment-naïve Patients With Type 2 Diabetes",Completed,Phase 3,281,Actual,Sanofi,Absolute change in HbA1C from baseline to Month 6.,"Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).",EFC5825,Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients,"A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20 mg) Multicenter Study of Long-Term Glycemic Control With Rimonabant in Treatment-naïve Patients With Type 2 Diabetes",,,Interventional,"Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",Phase 3,2005-11-21,2005-03-20,281,Completed,Sanofi,NULL,united states;argentina;chile;germany;hungary;netherlands;poland;united states;argentina;chile;germany;hungary;netherlands;poland,Drug: Rimonabant (SR141716),"
Inclusion Criteria:
- Male or female patients aged greater than or equal to 18 years.
- Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months but no
longer than 3 years.
- Type 2 diabetes not previously treated by a pharmacological agent.
Note:
- a) insulin use is accepted if it is not within 6 months prior to screening visit and
only for the following reasons:
- prior use for management of gestational diabetes,
- short-term (less than or equal to 1 month) use to maintain glycemic control for
hospitalization, medical procedures, or intervention.
- b) use of an oral antidiabetic agent is accepted if it is not within 6 months prior
to screening visit and only if it was prescribed for no more than 4 months.
- HbA1C greater than or equal to 7% and less than or equal to 10%.
- Having signed the informed consent form.
Exclusion Criteria:
General:
- Weight loss > 5 kg within 3 months prior to screening visit.
- Pregnancy or lactation.
- Absence of medically approved contraceptive methods for females of childbearing
potential.
- Marijuana or hashish users.
- Administration of other investigational drugs within 30 days prior to screening
visit.
- Previous participation in a rimonabant study.
- Presence or history of allergic reaction or intolerance to multiple drugs.
- Presence of any other condition (e.g., geographic, social) that the Investigator
feels that would restrict or limit the patient's participation for the duration of
the study.
Related to endocrine and metabolic disorders:
- Presence of any clinically significant endocrine disease according to the
Investigator.
Note: euthyroid patients on replacement therapy will be included if the dosage of
thyroxine is stable for at least 3 months prior to screening visit.
- Fasting C-peptide < 1.0 ng/mL.
Related to other disorders:
- Presence of any severe medical or psychological condition that in the opinion of the
Investigator would compromise the patient's safety or successful participation in the
study.
- Presence or history of cancer within the past five years with the exception of
adequately treated localized basal cell skin cancer or in situ uterine cervical
cancer.
Related to laboratory findings:
- Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
- Abnormal TSH level (TSH > ULN or < LLN).
- Hemoglobin < 11 g/dL and/or neutrophils < 1,500/mm3 and/or platelets < 100,000/mm3.
- Positive urine pregnancy test.
- Positive urine test for marijuana or hashish metabolites.
Related to previous or concomitant medications:
- Oral antidiabetic agent except if it is not within 6 months prior to screening visit
and only if it was prescribed for no more than 4 months.
- Insulin except if it is not within 6 months prior to screening visit and only for
management of gestational diabetes or short-term use to maintain glycemic control for
hospitalization, medical procedures, or intervention.
- Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
",NULL,Absolute change in HbA1C from baseline to Month 6.,"Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-03-31,2005-11-21,2005-11-21,281,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2005,NA,TRUE,FALSE,TRUE
35125,NA,NA,EUCTR2016-003352-67,NCT: NA ICTRP: 2017-01-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no measure",5,NA,NA,NCT: NA ICTRP: 86 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-08-10,NA,2018-02-22,2021-09-30,Interventional,Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors,A Phase 1/2 Single-arm Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan in Children With Refractory or Recurrent Solid Tumors,Recruiting,Phase 1/Phase 2,111,Anticipated,Eisai Inc.,Phase 1: Maximum Tolerated Dose (MTD) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Pediatric Participants With Relapsed/Refractory Solid Tumors (excluding CNS);Phase 1: Recommended Phase 2 Dose (RP2D) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Pediatric Participants With Relapsed/Refractory Solid Tumors (excluding CNS);Phase 2: Objective Response Rate (ORR),"Phase 1 and Phase 2: Number of Participants With any Treatment-emergent (TE) Serious Adverse Event (SAE);Phase 1 and Phase 2: Number of Participants With any TEAE;Phase 1, Cmax: Maximum Observed Plasma Concentration of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 1, AUC: Area Under the Plasma Concentration-time Curve of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 2, CL: Model Predicted Apparent Total Body Clearance of Eribulin;Phase 2, Vd: Model Predicted Apparent Total Body Volume of Distribution of Eribulin;Phase 2: Progression-free survival (PFS);Phase 2: The Clinical Benefit Rate (CBR)",2016-003352-67;E7389-G000-213,Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors,A Phase 1/2 Single-arm Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan in Children With Refractory or Recurrent Solid Tumors,esi_oncmedinfo@eisai.com,esi_oncmedinfo@eisai.com,Interventional,Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1/Phase 2,2017-08-08,2018-02-22,111,Recruiting,Eisai Inc.,NULL,france;germany;greece;italy;spain;united kingdom;france;germany;greece;italy;spain;united kingdom,Drug: Eribulin mesilate;Drug: Irinotecan hydrochloride,"
Participants must be
- >=12 months to less than or equal to (<=) 25 years old at the time of consent [no more
than 25 percent (%) of participants between the ages of 18 and 25 years will be
enrolled in this study].
- >6 months and <12 months at the time of consent (Phase 1 and Schedule A only)
participants will be enrolled one dose level behind the dose level at which the >=12
months to <18 years old group are enrolled.
Inclusion Criteria:
- Phase 1: Participants must be diagnosed with histologically confirmed solid tumors
(excluding CNS tumors), which is relapsed or refractory, and for which there are no
currently available therapies.
- Phase 2: Participants must be diagnosed with histologically confirmed RMS, NRSTS or
EWS which is relapsed or refractory having received at least 1 prior therapy,
including primary treatment.
- Phase 1: Participants must have either measurable or evaluable disease as per RECIST
1.1.
- Phase 2: Participants must have measurable disease as per RECIST 1.1.
- Participant's current disease state must be one for which there is no known curative
therapy.
- Participant's performance score must be >=50% Karnofsky (for participants >16 years of
age) or Lansky (for participants <=16 years of age).Participants who are unable to
walk because of paralysis and/or previous surgeries, but who are in a wheelchair, will
be considered ambulatory for the purpose of assessing the performance score.
- Participants must have fully recovered from the acute toxic effects of all prior
anticancer treatments prior to study drug administration:
- Must not have received myelosuppressive chemotherapy within 21 days prior to
study drug administration (42 days if prior nitrosourea).
- Must not have received a long-acting growth factor (eg, Neulasta) within 14 days
or a short-acting growth factor within 7 days.
- Must not have received an antineoplastic targeted therapy within 14 days.
- Must not have received immunotherapy, eg, tumor vaccines, within 42 days.
- Must not have received monoclonal antibodies within at least 3 half-lives of the
antibody after its last dose.
- Must not have received radiotherapy (XRT) within 14 days prior to study drug
administration (small field) or 42 days for craniospinal XRT, or if >=50%
radiation of pelvis.
- At least 84 days must have elapsed after stem cell infusion prior to study drug
administration
- No evidence of active graft-versus-host disease (GVHD) and at least 100 days must
have elapsed after allogeneic bone marrow transplant or stem cell infusion prior
to study drug administration
- Participants must have adequate bone marrow function, defined as:
- Peripheral absolute neutrophil count (ANC) >=1.0*10^9/liter (L).
- Platelet count >=100*10^9/L (not receiving platelet transfusions within a 7-day
period prior to study drug administration).
- Hemoglobin (Hb) at least 8.0 grams per deciliter (g/dL) at baseline (blood
transfusions are allowed during the screening period to correct Hb values less
than 8.0 g/dL).
- Participants must have adequate renal function, defined as:
- A serum creatinine based on age/gender, derived from the Schwartz formula for
estimating glomerular filtration rate (GFR), per protocol-specified criteria.
- Serum creatinine clearance or GFR >=50 milliliters/minute/1.73 m^2, based on a 12
or 24 hours (h) urine creatinine collection.
- Participants must have adequate liver function, defined as:
- Bilirubin (sum of conjugated + unconjugated) <=1.5 times the upper limit of
normal (ULN) for age.
- Alkaline phosphatase, alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) <=3*ULN (in the case of liver metastases <=5*ULN), unless
there are bone metastases, in which case liver-specific alkaline phosphatase must
be separated from the total and used to assess the liver function instead of the
total alkaline phosphatase.
- Serum albumin >=2 g/dL.
- All participants and/or their parents or guardians must sign a written informed
consent.
- Participants must be willing to comply with all aspects of the protocol.
Exclusion Criteria:
- Females who are breastfeeding or pregnant at Screening or Baseline. A separate
baseline assessment is required if a negative screening pregnancy test was obtained
more than 72 h before the first dose of study drug.
- Females of childbearing potential who:
- Do not agree to use a highly effective method of contraception for the entire
study period and for 6 months after study drug discontinuation, ie:
- Total abstinence (if it is their preferred and usual lifestyle)
- An intrauterine device (IUD) or intrauterine system (IUS)
- A contraceptive implant
- An oral contraceptive OR
- Do not have a vasectomized partner with confirmed azoospermia.
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and
their female partners do not meet the criteria above (ie, not of childbearing
potential or practicing highly effective contraception throughout the study period or
for 3 months after study drug discontinuation). No sperm donation is allowed during
the study period or for 3 months after study drug discontinuation.
- Concomitant Medications:
- Participants receiving corticosteroids who have not been on a stable dose for at
least 7 days prior to study drug administration.
- Participants who are currently receiving other anticancer agents.
- Participants who are receiving cyclosporine, tacrolimus or other agents to
prevent GVHD post bone marrow transplant.
- Participants who are receiving strong cytochrome P450 3A4 (CYP3A4) inhibitors and
inducers including traditional herbal medicinal products (eg St. John's Wort).
- Phase 1: Received prior therapy with eribulin mesilate within 6 months prior to study
drug administration.
- Phase 2: Received prior therapies with eribulin mesilate or irinotecan hydrochloride
(for prior irinotecan hydrochloride, participants can be included if there was no
tumor progression during irinotecan therapy).
- Any other malignancy that required trea",NULL,Phase 1: Maximum Tolerated Dose (MTD) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Pediatric Participants With Relapsed/Refractory Solid Tumors (excluding CNS);Phase 1: Recommended Phase 2 Dose (RP2D) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Pediatric Participants With Relapsed/Refractory Solid Tumors (excluding CNS);Phase 2: Objective Response Rate (ORR),"Phase 1 and Phase 2: Number of Participants With any Treatment-emergent (TE) Serious Adverse Event (SAE);Phase 1 and Phase 2: Number of Participants With any TEAE;Phase 1, Cmax: Maximum Observed Plasma Concentration of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 1, AUC: Area Under the Plasma Concentration-time Curve of Eribulin, Irinotecan and its Active Metabolite SN-38;Phase 2, CL: Model Predicted Apparent Total Body Clearance of Eribulin;Phase 2, Vd: Model Predicted Apparent Total Body Volume of Distribution of Eribulin;Phase 2: Progression-free survival (PFS);Phase 2: The Clinical Benefit Rate (CBR)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-02-22,2017-08-08,2017-08-08,111,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,NA,TRUE,FALSE,TRUE
25927,NA,NA,ISRCTN98496463,NCT: NA ICTRP: 2014-03-19 DRKS: NA,1,NA,NA,1,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure",4,NA,no AM,NCT: NA ICTRP: 4439 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,"Given outcomes not in line with title. According to title validation of models, but outcomes refer only to collected variables.",kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,601826,Validating predictive models and biomarkers of radiotherapy toxicity to reduce side effects and improve quality of life in cancer survivors,Validating predictive models and biomarkers of radiotherapy toxicity to reduce side effects and improve quality of life in cancer survivors: a prospective observational cohort study ,catharine.west@manchester.ac.uk,,Observational,Prospective observational cohort study (Quality of life),Not Applicable,2014-03-19,2014-04-01,4439,Completed,University of Manchester (UK),NULL,belgium;france;germany;italy;netherlands;spain;united kingdom;united states of america,
A pre-treatment blood sample will be collected from every patient at a single time point for downstream analyses. This sample comprises:
Sample A: a whole blood EDTA sample for DNA extraction
and either
Sample B: a whole blood PAXgene sample for RNA extraction
or
Sample C: a whole blood Lithium Heparin sample for the apoptosis assay.
Toxicity will be assessed and documented using REQUITE toxicity questionnaires based on the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and EORTC Quality of Life. At some sites additional questionnaires will also be used: Multiple Fatigue Inventory (MFI) and the General Practice Assessment
Questionnaire (GPAQ). Questionnaires will be completed at the following time points:
1. Baseline assessed prior to radiotherapy (all)
2. End of radiotherapy (breast and prostate); or first follow-up visit following implantation for prostate brachytherapy patients
3. 3 months from start of radiotherapy (lung)
4. 6 months from start of radiotherapy (lung)
5. 12 months from start of radiotherapy (all)
6. 24 months from start of radiotherapy (all)
The follow-up period can be extended beyond 24 months. Further follow-up will be permissible and encouraged where possible as part of routine clinical care.
,"Inclusion criteria:
1. Patients suitable for adjuvant radiotherapy* for cancer of the breast (invasive or in situ) including breast patients receiving neo-adjuvant chemotherapy
2. Patients suitable for radical radiotherapy or brachytherapy for prostate cancer; including post-prostatectomy patients
3. Patients suitable for radical radiotherapy, sequential or concurrent chemoradiotherapy or stereotactic body radiation therapy for lung cancer
4. No other malignancy prior to treatment for the specified tumour types except basal cell or squamous cell carcinoma of the skin
5. No evidence of distant metastases
6. Patients able to provide a venous blood sample
7. Willingness and ability to comply with scheduled visits, treatment plans and available for follow-up within country of origin
8. Greater than 18 years of age; no upper age limit
9. The capacity to understand the patient information sheet and the ability to provide written informed consent
*Breast patients receiving chemotherapy should have completed their course of chemotherapy (anthracyclines) at least one month prior to radiotherapy commencing.
",Exclusion criteria:
1. Patients with metastatic disease
2. Prior irradiation at the same site
3. Planned use of protons
4. Breast patients receiving concomitant chemo-radiation
5. Male breast cancer patients
6. Mastectomy patients
7. Bilateral breast cancer
8. Small cell lung cancer
9. Mental disability or patient otherwise unable to give informed consent and/or complete patient questionnaires
10. Limited life expectancy due to co-morbidity
11. Pregnant patients
12. Partial breast irradiation
13. Patients with breast implants if not removed during surgery
14. Patients with known HIV infection/infectious hepatitis
,
1. Change in breast appearance at 24 months following start of radiotherapy (breast) measured by digital photograph
2. Rectal bleeding at 24 months following start of radiotherapy (prostate) measured by patient-reported outcome toxicity questionnaires
3. Dyspnea/breathlessness at 12 months following start of radiotherapy (lung) measured by patient-reported outcome toxicity questionnaires
,"
1. Other toxicity endpoints including but not limited to: fibrosis, induration and vascular changes (breast); rectal incontinence, urinary toxicity and erectile dysfunction (prostate); dysphagia and oesophagitis (lung)
2. Quality of life
3. Maximum grade of toxicity during follow-up period
Toxicity will be assessed and documented using REQUITE toxicity questionnaires based on the CTCAE v4.0 and EORTC Quality of Life at the following time points.
1. Baseline assessed prior to radiotherapy (all)
2. End of radiotherapy (breast and prostate); or first follow-up visit following implantation for prostate brachytherapy patients
3. 3 months from start of radiotherapy (lung)
4. 6 months from start of radiotherapy (lung)
5. 12 months from start of radiotherapy (all)
6. 24 months from start of radiotherapy (all)
",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-04-01,NA,2014-03-19,4439,Observational,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,TRUE,NA,TRUE,2014,NA,FALSE,FALSE,FALSE
22324,NA,NA,ISRCTN36008820,NCT: NA ICTRP: 2017-08-02 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,3,NA,"no AM, no measure (definition of prediction model)",4,NA,no AM,NCT: NA ICTRP: 300 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,CU_001_300,Cardiovascular remodeling in small-for-gestational-age fetuses,Fetal programming: Evaluation of cardiovascular remodeling in late-onset small-for-gestational-age fetuses and prediction of adverse birth and intermediate-term cardiovascular outcome ,silvia.lobmaier@tum.de,,Observational,Prospective longitudinal observational study (Diagnostic),,2017-08-02,2016-09-01,300,Recruiting,Else Kröner-Fresenius Foundation (Else Kröner-Fresenius-Stiftung),NULL,germany,"This study is a prospective longitudinal observational study that includes participants consecutively. All cases are seen at the high risk SGA outpatient ward. The source population is recruited from the population under treatment with term fetuses (Gestational age =32 weeks at inclusion and born after 37 weeks gestation) suspected of growth restriction defined as an estimated fetal weight or fetal abdominal circumference, measured below the 10th population or customized percentile or a change of abdominal circumference <5mm in 2 weeks (=reduced growth velocity according to Green Top Guidelines).
Diagnostic tools
During pregnancy: Pregnancies complicated with suspected growth restriction are followed each two to three weeks until delivery in a routinue fashion including fetal biometry, advanced ultrasound investigation (including fetal functional echocardiography: Aortic intima media thickness, aortic distensibility, right/Left sphericity index, right/Left cardiac output, tricuspid annular plane systolic excursion (TAPSE), right E/A ratio, tight E´,left myocardial performance index, including IRT measurement, strain/strain rate), feto-maternal Doppler, measurement of amniotic fluid and placenta, and registration of fetal heart rate with fetal ECG (AN 24 MONICA device) and simultaneously with conventional computerised CTG for 40 minutes.
Obstetric ultrasound examinations are performed using Voluson E8 or Samsung HS 70A whereas functional echocardiographic parameter are measured using Samsung HS 70 A. All functional echocardiographic parameters are calculated off-line within four weeks after evaluation according to a standardised protocol based on a trace method with the assistance of commercially available software (TOMTEC ImageArena software). AGA group will be scanned to get 15 controls for each gestational week from 32 to 41 weeks of gestation.
During birth: Participants receive the standard evaluation during labour as do other pregnancies complicated by FGR. ",Inclusion criteria: 1. Pregnant women aged 18 and older
2. Fetuses with a gestational age = 32 weeks
3. Suspected of growth restriction defined as an estimated fetal weight or fetal abdominal circumference measured below the 10th population or customized percentile or a change of abdominal circumference <5mm in 2 weeks measured by ultrasound ,Exclusion criteria: 1. Born <37 weeks gestational age
2. Known chromosomal and/or structural anomaly
3. Multiple gestation
4. Mothers with cardiac heart disease
5. Mothers’ severe systemic disease
6. Antihypertensive medication
7. Antenatal intra-uterine infection
,"Prediction of mean blood pressure (BP) (in mmHg) at one year of age is measured using the average acceleration capacity (bpm), tricuspid annular plane systolic excursion (mm), right sphericity index, Strain-rate, aortic distensibility, isovolumetric relaxation time (ms)) during pregnancy.","1. Adverse birth outcomes are measured using
1.1. Mortality defined as intra-uterine death or death before hospital discharge
1.2. Acidosis defined as arterial cord blood pH<7.15
1.3. Apgar at 5 minutes <7
1.4. Admission to NICU
1.5. Operative delivery for fetal distress (fetal scalp blood analysis pH < 7.20 or abnormal fetal heart rate tracing
2. Abnormal child growth pattern are measured using patient records (as defined below the 10th percentile of normal population) during first year of life
3. Abnormal metabolic profile (umbilical cord blood) at birth in comparision to the control group
4. Abnormal cardiovascular outcomes are measured using aortic intima media thickness >75th centile and/or BP > 95th centile at birth and at 12 months of age
5. Prediction of mean blood pressure (BP) at one year of age (mm Hg) using the following measurements: metabolic profile, fetal functional echocardiographic parameters others than the ones used for primary outcome
6. Correlation of mean blood pressure (BP) at one year of age (mm Hg) and autonomic nervous system [average acceleration and deceleration capacity (bpm)] and antenatal/ fetal functional echocardiographic parameters
7. Correlation of antepartal cardiac function parameters and those at 1 year of life
",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-09-01,NA,2017-08-02,300,Observational,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2016,NA,FALSE,FALSE,FALSE
28850,NA,NA,ISRCTN97265367,NCT: NA ICTRP: 2008-04-04 DRKS: NA,1,1,NA,2,1,r,Criteria more specific in register,2,1,NA,4,1,Aggregation Method missing,4,0,Aggregation Method missing; Article: Not reported.,NCT: NA ICTRP: 400 DRKS: NA,150,1,0,NA,NA,NA,NA,NA,NA,0,No outcome,ganzer Artikel,https://doi.org/10.1016/j.jpor.2020.01.005,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,DFG WA 831/2-1 to 2-6,Randomised multicentre study of prosthetic treatment options for shortened dental arch,Randomised multicentre study of prosthetic treatment options for shortened dental arch ,Michael.Walter@uniklinikum-dresden.de,,Interventional,Multi-centre randomised controlled clinical trial (Treatment),Not Specified,2008-04-04,2000-10-01,400,Completed,German Research Foundation (Deutsche Forschungsgemeinschaft),"Deutsche Gesellschaft für Prothetische Zahnmedizin und Biomaterialien e.V. (DGPRo);Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde (DGZMK);Cendres+Métaux SA",germany,"Control group (Therapy A): The molar replacement by removable partial dentures, carried out using fixed crowns and bridges as anchor for removable dentures
Intervention group (Therapy B): Restorations according to the SDA concept, with only fixed restorations or no restoration at all. The maximum extension reached up to the second premolar, and no molars were replaced. All restorations were made according to a standardized procedure (SOP) given by the study protocol.
Standard gold alloys and dental ceramics were used for fixed restorations, base metal alloys for the removable denture frameworks.","Inclusion criteria: 1. Patients over 35 years of age, who requested prosthetic treatment with a minimum dentition of both canines and one premolar per side preserved in at least one jaw (Kennedy class I). A dentition including all anterior teeth up to the second premolar on both sides in one jaw was defined as maximum
2. Rejection of implant treatment by the patient
3. Patients with general health according to American Society of Anesthesiologists (ASA) classification group one ore two
4. All abutment teeth must be free of periodontal disease (pocket depth less or equal 4 mm, tooth mobility <= grade 2, mean plaque index <= grade 2, bleeding on probing at all teeth <=25 %) and caries
5. Caries free adjacent teeth
6. Sufficient treatment of the opposite jaw, extending the dentition depending on the randomized treatment option up to the second premolar or the first molar",Exclusion criteria: 1. Patients with alcohol or drug addiction
2. Mentally disordered patients
3. Patients with TMJ disorders
4. Dysgnathic patients with Angle class II or III
5. Patients who have received or need orthodontical treatment
6. Patients who have been already sufficiently treated
7. Patients who do not accept a removable deture
8. Patients who demand the replacement of all molars
9. Patients with general health American Society of Anesthesiologists (ASA) classification group four,"Further tooth loss is measured at 5, 8, 10 and 15 years","The following will be assessed at baseline (4-8 weeks after insertion), 6 month, then annually from Year 1 to 5, and further at 8, 10 and 15 years:
1. Clinical:
1.1. Crown/root caries
1.2. Abrasion (Index 0-4)
1.3. Interdental spacing in the anterior region (Index 0-3)
1.4. Sensibility (+/-)
1.5. Periodontitis/Gingivitis: Plaque-index (index 0-3), probing depth (6 point measurement in mm), attachment loss (6 point measurement in mm), bleeding on probing (BOP)(+/-), tooth mobility (index 0-3), mucosa lesions (California Dental Association [CDA] Criteria)
2. Clinical dysfunction index: Muscle pain via palpation (m. masseter pars profunda et superficialis, m. temporalis pars posterior et anterior, m. pterygoideus medialis et lateralis)
3. Range of movement (mm): maximal opening
4. TMJ function: Description of pain on movement/path of movement, palpation/auscultation
5. Technical (according to the CDA criteria): Treatment performance, preparation form, marginal fit, occlusion static/dynamic in µm, proximal contacts (shape/ strength)
6. Technical performance (according to the CDA criteria): Evaluation of used materials, prosthesis and bridge design, saddle extension, possibility of dental hygiene
Subjective:
9. Oral health related quality of life (OHIP-Questionnaire): Measure of self reported dysfunction, discomfort and disability attributed to oral conditions
10. Dworkin Index Axis II (questionnaire): Assessment of psychological distress and psychosocial dysfunction including questions regarding:
10.1. Graded chronic pain severity
10.2. Depression
10.3. Vegetative symptoms and somatization subscales of the SCL-90-R developed by Derogatis and others
10.4. Jaw disability checklist
The CDA Criteria are used according to the Guidelines for the Assessment of Clinical Quality and Professional Performance of the California Dental Association: http://www.cda.org/library/cda_member/policy/quality/quality.html",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-10-01,NA,2008-04-04,400,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2000,NA,FALSE,FALSE,FALSE
30415,NA,NA,EUCTR2006-000560-93,NCT: NA ICTRP: 2006-05-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,one dosage missing,4,NA,no AM,NA,NA,NA,NCT: NA ICTRP: 120 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2006-06-05,NA,2006-08-31,2006-12-31,Interventional,Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.,Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23,Completed,Phase 3,120,NA,GlaxoSmithKline,Antibody concentrations against pneumococcal serotypes 1 month post-booster,Immunogenicity pre and post-booster and safety (follow up of SAEs),106623;106623,Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.,Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23,;,;,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention",Phase 3,2006-06-02,2006-08-20,120,Completed,GlaxoSmithKline,NULL,germany;germany,Biological: Pneumococcal vaccine;Biological: Pneumococcal vaccine,"
Inclusion:
- healthy children between 11-14 months old who received primary vaccination with
Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.
Exclusion:
- children having received or planning to receive any investigational products,
vaccines not foreseen in the protocol and immune modifying drugs;
- children having received any additional pneumococcal vaccine than in the primary
study;
- children with any disease that affect the immune system and history of seizures
and/or allergic disease.
;
Inclusion:
- healthy children between 11-14 months old who received primary vaccination with
Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.
Exclusion:
- children having received or planning to receive any investigational products,
vaccines not foreseen in the protocol and immune modifying drugs;
- children having received any additional pneumococcal vaccine than in the primary
study;
- children with any disease that affect the immune system and history of seizures
and/or allergic disease.
",NULL,Antibody concentrations against pneumococcal serotypes 1 month post-booster;Antibody concentrations against pneumococcal serotypes 1 month post-booster,Immunogenicity pre and post-booster and safety (follow up of SAEs);Immunogenicity pre and post-booster and safety (follow up of SAEs),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-08-31,2006-06-02,2006-06-02,120,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2006,NA,TRUE,FALSE,TRUE
29622,NA,NA,EUCTR2004-004450-96,NCT: NA ICTRP: 2004-12-21 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no time frame,NCT: NA ICTRP: 180 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,No outcome,kein Artikel,NA,NA,2005-02-16,NA,2005-02-28,2008-03-31,Interventional,Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia,A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d,Completed,Phase 2,150,Actual,Bristol-Myers Squibb,Number of Participants With Major Cytogenetic Response (MCyR) at Week 12,"MCyR at Any Time Prior to Crossover;Duration of MCyR at 12 Months and 18 Months;Duration of MCyR at 24 Months;Time to MCyR Prior to Crossover;Complete Hematologic Response (CHR) at Any Time Prior to Crossover;Duration of Complete Hematologic Response (CHR);Time to CHR Prior to Crossover;Major Molecular Response (MMR);CHR After Crossover;Cytogenetic Response After Crossover;Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover;Health-Related Quality of Life Prior to Crossover;Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib",CA180-017,Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia,A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d,;;;,;;;,Interventional,,Phase 2,2005-02-15,2005-02-20,150,Completed,Bristol-Myers Squibb,NULL,"united states;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;united states;united states;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;united states;united states;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;united states;united states;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;argentina;australia;austria;belgium;brazil;canada;china;denmark;estonia;finland;france;germany;hungary;ireland;israel;italy;korea, republic of;norway;peru;philippines;poland;puerto rico;russian federation;singapore;south africa;spain;sweden;switzerland;taiwan;thailand;united kingdom;united states",Drug: Dasatinib;Drug: Imatinib;Drug: Dasatinib;Drug: Imatinib;Drug: Dasatinib;Drug: Imatinib;Drug: Dasatinib;Drug: Imatinib,"
Inclusion Criteria:
- Men and women, 18 years of age or older.
- Subjects with Chronic Phase Ph+ CML.
- Subjects have not been treated with imatinib at a dose >600 mg/day.
- Subjects developed resistance to disease while receiving an imatinib dose 400-600
mg/day.
- Able to tolerate imatinib at the highest dose the subject had received in the past.
- Demonstrate adequate renal and hepatic function.
- Women of childbearing potential must have a negative serum or urine pregnancy test,
must be using an adequate method of contraception.
Exclusion Criteria:
- Women who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period for a least 1 month before and at least 3 months after the
completion of the study.
- Women using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Men whose sexual partners are women who are of childbearing potential, and who are
unwilling or unable to use an acceptable method to avoid pregnancy of his partner for
the entire study period as outlined above.
- Prior treatment with imatinib at a dose >600 mg/day.
- Subjects who have previously identified specific BCR-ABL mutations.
- Previous diagnosis of accelerated phase or blast crisis CML.
- Intolerance to imatinib at any dose.
- Subjects who are eligible and willing to undergo transplantation during the screening
period.
- Serious uncontrolled medical disorder or active infection.
- Uncontrolled or significant cardiovascular disease.
- Uncontrolled hypertension.
- Dementia or altered mental status.
- Evidence of organ dysfunction.
- Use of imatinib within 7 days.
- Use of interferon or cytarabine within 14 days.
- Use of a targeted small molecule anticancer agent within 14 days.
- Subjects taking certain medications that are accepted to have a risk of causing
Torsades de Pointes.
- Subjects taking medications that irreversibly inhibit platelet function or
anticoagulants.
- Prior therapy with BMS-354825.
;
Inclusion Criteria:
- Men and women, 18 years of age or older.
- Subjects with Chronic Phase Ph+ CML.
- Subjects have not been treated with imatinib at a dose >600 mg/day.
- Subjects developed resistance to disease while receiving an imatinib dose 400-600
mg/day.
- Able to tolerate imatinib at the highest dose the subject had received in the past.
- Demonstrate adequate renal and hepatic function.
- Women of childbearing potential must have a negative serum or urine pregnancy test,
must be using an adequate method of contraception.
Exclusion Criteria:
- Women who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period for a least 1 month before and at least 3 months after the
completion of the study.
- Women using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Men whose sexual partners are women who are of childbearing potential, and who are
unwilling or unable to use an acceptable method to avoid pregnancy of his partner for
the entire study period as outlined above.
- Prior treatment with imatinib at a dose >600 mg/day.
- Subjects who have previously identified specific BCR-ABL mutations.
- Previous diagnosis of accelerated phase or blast crisis CML.
- Intolerance to imatinib at any dose.
- Subjects who are eligible and willing to undergo transplantation during the screening
period.
- Serious uncontrolled medical disorder or active infection.
- Uncontrolled or significant cardiovascular disease.
- Uncontrolled hypertension.
- Dementia or altered mental status.
- Evidence of organ dysfunction.
- Use of imatinib within 7 days.
- Use of interferon or cytarabine within 14 days.
- Use of a targeted small molecule anticancer agent within 14 days.
- Subjects taking certain medications that are accepted to have a risk of causing
Torsades de Pointes.
- Subjects taking medications that irreversibly inhibit platelet function or
anticoagulants.
- Prior therapy with BMS-354825.
;
Inclusion Criteria:
- Men and women, 18 years of age or older.
- Subjects with Chronic Phase Ph+ CML.
- Subjects have not been treated with imatinib at a dose >600 mg/day.
- Subjects developed resistance to disease while receiving an imatinib dose 400-600
mg/day.
- Able to tolerate imatinib at the highest dose the subject had received in the past.
- Demonstrate adequate renal and hepatic function.
- Women of childbearing potential must have a negative serum or urine pregnancy test,
must be using an adequate method of contraception.
Exclusion Criteria:
- Women who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period for a least 1 month before and at least 3 months after the
completion of the study.
- Women using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Men whose sexual partners are women who are of childbearing potential, and who are
unwilling or unable to use an acceptable method to avoid pregnancy of his partner for
the entire study period as outlined above.
- Prior treatment with imatinib at a dose >600 mg/day.
- Subjects who have previously identified specific BCR-ABL mutations.
- Previous diagnosis of accelerated phase or blast crisis CML.
- Intolerance to imatinib at any dose.
- Subjects who are eligible and willing to undergo transplantation during the screening
period.
- Serious uncontrolled medical disorder or active infection.
- Uncontrolled or significant cardiovascular disease.
- Uncontrolled hypertension.
- Dementia or altered mental status.
- Evidence of organ dysfunction.
- Use of imatinib within 7 days.
- Use of interferon or cytarabine within 14 days.
- Use of a targeted small molecule anticancer agent within 14 days.
- Subjects taking certain medications that are accepted to have a risk of causing
Torsades de Pointes.
- Subjects taking medications that irreversibly inhibit platelet function or
anticoagulants.
- Prior therapy with BMS-354825.
;
Inclusion Criteria:
- Men and women, 18 years of age or older.
- Subjects with Chronic Phase Ph+ CML.
- Subjects have not been treated with imatinib at a dose >600 mg/day.
- Subjects developed resistance to disease while receiving an imatinib dose 400-600
mg/day.
- Able to tolerate imatinib at the highest dose the subject had received in the past.
- Demonstrate adequate renal and hepatic function.
- Women of childbearing potential must have a negative serum or urine pregnancy test,
must be using an adequate method of contraception.
Exclusion Criteria:
- Women who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period for a least 1 month before and at least 3 months after the
completion of the study.
- Women using a prohibited contraceptive method.
- Women who are pregnant or breastfeeding.
- Men whose sexual partners are women who are of childbearing potential, and who are
unwilling or unable to use an acceptable method to avoid pregnancy of his partner for
the entire study period as outlined above.
- Prior treatment with imatinib at a dose >600 mg/day.
- Subjects who have previously identified specific BCR-ABL mutations.
- Previous diagnosis of accelerated phase or blast crisis CML.
- Intolerance to imatinib at any dose.
- Subjects who are eligible and willing to undergo transplantation during the screening
period.
- Serious uncontrolled medical disorder or active infection.
- Uncontrolled or significant cardiovascular disease.
- Uncontrolled hypertension.
- Dementia or altered mental status.
- Evidence of organ dysfunction.
- Use of imatinib within 7 days.
- Use of interferon or cytarabine within 14 days.
- Use of a targeted small molecule anticancer agent within 14 days.
- Subjects taking certain medications that are accepted to have a risk of causing
Torsades de Pointes.
- Subjects taking medications that irreversibly inhibit platelet function or
anticoagulants.
- Prior therapy with BMS-354825.
",NULL,Number of Participants With Major Cytogenetic Response (MCyR) at Week 12;Number of Participants With Major Cytogenetic Response (MCyR) at Week 12,"MCyR at Any Time Prior to Crossover;Duration of MCyR at 12 Months and 18 Months;Duration of MCyR at 24 Months;Time to MCyR Prior to Crossover;Complete Hematologic Response (CHR) at Any Time Prior to Crossover;Duration of Complete Hematologic Response (CHR);Time to CHR Prior to Crossover;Major Molecular Response (MMR);CHR After Crossover;Cytogenetic Response After Crossover;Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover;Health-Related Quality of Life Prior to Crossover;Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2005-02-28,2005-02-15,2005-02-15,150,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2005,NA,TRUE,FALSE,TRUE
29329,NA,NA,ISRCTN63474366,NCT: NA ICTRP: 2003-10-29 DRKS: NA,1,1,NA,2,1,r,Criteria more specific in register,1,1,NA,2,1,"no AM, no time frame, no measure",NA,NA,NA,NCT: NA ICTRP: 1250 DRKS: NA,1502,1,0,NA,NA,NA,NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1016/s0140-6736(14)61469-0,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,N/A,HD13 for early stage Hodgkin's disease: quality assurance protocol for reduction of toxicity in the first-line treatment of early stage Hodgkin's Disease (HD),HD13 for early stage Hodgkin's disease: quality assurance protocol for reduction of toxicity in the first-line treatment of early stage Hodgkin's Disease (HD) ,dhsg@biometrie.uni-koeln.de,,Interventional,Randomised controlled trial (Treatment),Not Applicable,2003-10-29,2003-01-01,1250,Completed,German Hodgkin's Lymphoma Study Group (Germany),NULL,germany,"Arm A: 2 x Doxorubicin, Bleomycin, Vinblastine, Dacarbazine (ABVD) and 30 Gy Involved Field Radiotherapy (IF-RT)
Arm B: 2 x Doxorubicin, Bleomycin, Vinblastine (ABV) and 30 Gy IF-RT
Arm C: 2 x Doxorubicin, Vinblastine, Dacarbazine (AVD) and 30 Gy IF-RT
Arm D: 2 x Doxorubicin, Vinblastine (AV) and 30 Gy IF-RT","Inclusion criteria: 1. Histologically confirmed Hodgkin's disease
2. Stages IA (not lympocyte predominant HD), IB, IIA, and IIB without the following risk factors:
2.1. Massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter
2.2. Extranodal involvement
2.3. High Erythrocyte Sedimentation Rate (ESR) (greater than or equal to 50 mm; greater than or equal to 30 mm with B symptoms)
2.4. Three or more involved lymph node areas
3. No prior therapy for Hodgkin's disease
4. Aged 18 - 75 years
5. No major organ dysfunction
6. Life expectancy more than three months
7. Written informed consent","Exclusion criteria: 1. Incomplete staging
2. Major organ dysfunction (Chronic Obstructive Pulmonary Disease [COPD] with respiratory insufficiency, symptomatic Coronary Heart Disease [CHD], cardiomyopathy or heart failure [ejection fraction less than 50%], severe hypertension, non-treatable infections, white blood count less than 3000/mm^3 or platelets less than 100,000/mm^3, creatinine clearance less than 60 ml/min, bilirubin more than 2 mg/dl, Glutamic-Oxaloacetic Transaminase [GOT]/aspartate aminotransferase [AST] more than 100 U/l, Glutamic-Pyruvic Transaminase [GPT]/alanine aminotransferase [ALT] more than 100 U/l, Human Immunodeficiency Virus [HIV]-infection)
3. Composite lymphoma
4. Prior chemotherapy or radiotherapy
5. Any history of another malignancy in the last five years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1)
6. Pregnancy or breastfeeding
7. World Health Organization (WHO) performance status more than two
8. Long term use of corticosteroids (e.g. for arthritis) or antineoplastic substances (e.g. methotrexate)
9. Expected non compliance
10. Current therapy for epilepsy
11. Intolerabilities against study drugs
12. Inability to give truly informed consent",Freedom From Treatment Failure (FFTF) .,Not provided at time of registration,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2003-01-01,NA,2003-10-29,1250,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2003,NA,FALSE,FALSE,FALSE
35581,NA,NA,EUCTR2017-003823-31,NCT: NA ICTRP: 2018-05-21 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 76 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-06-07,NA,2018-08-09,2020-10-09,Interventional,A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency",Completed,Phase 3,80,Actual,"Agios Pharmaceuticals, Inc.",Percentage of Participants Achieving a Hemoglobin Response (HR) in Part 2,"Change from Baseline in Hb Concentration at Weeks 16, 20 and 24 in Part 2;Maximum Change from Baseline in Hb Concentration;Time to Achieve an Increase in Hb Concentration of 1.5 g/dL or More;Change from Baseline in Bilirubin at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Lactic Acid Dehydrogenase (LDH) at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Haptoglobin at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Reticulocyte Percentages at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Pyruvate Kinase Deficiency Diary (PKDD) Score;Change from Baseline in Pyruvate Kinase Deficiency Impact Assessment (PKDIA) Score;Percentage of Participants Experiencing an Adverse Event;Percentage of Participants Experiencing an Adverse Event of Special Interest (AESI);Change from Baseline in Bone Mineral Density Z-Score at Week 24 in Part 2;Change from Baseline in Bone Mineral Density T-Score at Week 24 in Part 2;Area Under the Curve From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] for AG-348 at Week 12;Maximum Plasma Concentration (Cmax) for AG-348;Time to Cmax (Tmax) for AG-348;Time to Last Measurable Concentration (Tlast) for AG-348",AG348-C-006,A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD),"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 3,2018-05-24,2018-08-09,80,Completed,"Agios Pharmaceuticals, Inc.",NULL,"united states;brazil;canada;czechia;denmark;france;germany;italy;japan;korea, republic of;netherlands;portugal;spain;switzerland;thailand;turkey;united kingdom;brazil;canada;czechia;denmark;france;germany;italy;japan;korea, republic of;netherlands;portugal;spain;switzerland;thailand;turkey;united kingdom;united states;poland",Drug: AG-348;Drug: Placebo,"
Inclusion Criteria:
- Informed consent;
- Male or female, aged 18 years or older;
- Documented clinical laboratory confirmation of pyruvate kinase deficiency (PKD),
defined as documented presence of at least 2 mutant alleles in the PKLR gene, of which
at least 1 is a missense mutation;
- Hb concentration less than or equal to 10.0 g/dL regardless of gender (average of at
least 2 Hb measurements [separated by a minimum of 7 days] during the Screening
Period)
- Considered not regularly transfused, defined as having had no more than 4 transfusion
episodes in the 12-month period up to the first day of study treatment and no
transfusions in the 3 months prior to the first day of study treatment;
- Received at least 0.8 mg oral folic acid daily for at least 21 days prior to the first
dose of study treatment, to be continued daily during study participation.
- Adequate organ function;
- Women of reproductive potential, have a negative serum pregnancy test;
- For women of reproductive potential as well as men with partners who are women of
reproductive potential, be abstinent as part of their usual lifestyle, or agree to use
2 forms of contraception, 1 of which must be considered highly effective, from the
time of giving informed consent, during the study, and for 28 days following the last
dose of study treatment for women and 90 days for men following the last dose of study
treatment;
- Willing to comply with all study procedures for the duration of the study;
Exclusion Criteria:
- Homozygous for the R479H mutation or have 2 non-missense mutations, without the
presence of another missense mutation, in the PKLR gene;
- Significant medical condition that confers an unacceptable risk to participating in
the study, and/or that could confound the interpretation of the study data;
- Splenectomy scheduled during the study treatment period or have undergone splenectomy
within 12 months prior to signing informed consent;
- Currently enrolled in another therapeutic clinical trial involving ongoing therapy
with any investigational or marketed product or placebo. Prior and subsequent
participation in the PK Deficiency Natural History Study (NHS) (NCT02053480) or PK
Deficiency Registry is permitted however, concurrent participation is not;
participants enrolling in this current study will be expected to temporarily suspend
participation in the NHS or Registry;
- Exposure to any investigational drug, device, or procedure within 3 months prior to
the first dose of study treatment;
- Prior treatment with a pyruvate kinase activator;
- Prior bone marrow or stem cell transplant;
- Currently pregnant or breastfeeding;
- History of major surgery within 6 months of signing informed consent;
- Currently receiving medications that are strong inhibitors of cytochrome P450
(CYP)3A4, strong inducers of CYP3A4, strong inhibitors of P-glycoprotein (P-gp), or
digoxin (a P-gp sensitive substrate medication) that have not been stopped for a
duration of at least 5 days or a timeframe equivalent to 5 half-lives (whichever is
longer) prior to the first dose of study treatment;
- Currently receiving hematopoietic stimulating agents that have not been stopped for a
duration of at least 28 days prior to the first dose of study treatment;
- History of allergy to sulfonamides if characterized by acute hemolytic anemia, drug
induced liver injury, anaphylaxis, rash of erythema multiforme type or Stevens-Johnson
syndrome, cholestatic hepatitis, or other serious clinical manifestations;
- History of allergy to AG-348 or its excipients;
- Currently receiving anabolic steroids, including testosterone preparations, within 28
days prior to treatment.
",NULL,Percentage of Participants Achieving a Hemoglobin Response (HR) in Part 2,"Change from Baseline in Hb Concentration at Weeks 16, 20 and 24 in Part 2;Maximum Change from Baseline in Hb Concentration;Time to Achieve an Increase in Hb Concentration of 1.5 g/dL or More;Change from Baseline in Bilirubin at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Lactic Acid Dehydrogenase (LDH) at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Haptoglobin at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Reticulocyte Percentages at Weeks 16, 20 and 24 in Part 2;Change from Baseline in Pyruvate Kinase Deficiency Diary (PKDD) Score;Change from Baseline in Pyruvate Kinase Deficiency Impact Assessment (PKDIA) Score;Percentage of Participants Experiencing an Adverse Event;Percentage of Participants Experiencing an Adverse Event of Special Interest (AESI);Change from Baseline in Bone Mineral Density Z-Score at Week 24 in Part 2;Change from Baseline in Bone Mineral Density T-Score at Week 24 in Part 2;Area Under the Curve From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] for AG-348 at Week 12;Maximum Plasma Concentration (Cmax) for AG-348;Time to Cmax (Tmax) for AG-348;Time to Last Measurable Concentration (Tlast) for AG-348",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-08-09,2018-05-24,2018-05-24,80,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,NA,TRUE,FALSE,TRUE
35269,NA,NA,EUCTR2016-005022-10,NCT: NA ICTRP: 2017-11-09 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,"time frame unclear, no measure",3,NA,"time frame unclear, no measure",NCT: NA ICTRP: 28 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no intervention,kein Artikel,NA,NA,2018-04-20,NA,2019-03-22,2022-01-31,Interventional,Synaptic Plasticity and Cognitive Function in RASopathies,Improvement of Synaptic Plasticity and Cognitive Function in RAS Pathway Disorders,Recruiting,Phase 2,14,Anticipated,Technische Universität München,Long-term potentiation (LTP)-like plasticity measured with transcranial magnetic stimulation (TMS),Difference between the neuropsychological testing of attention (Test of attentional performance) after placebo and after medication (LTG and LOV);Differences in short interval cortical inhibition (SICI) after placebo and after medication (LTG and LOV),2016-005022-10;SYN-1748-MAL-0030-I,Synaptic Plasticity and Cognitive Function in RASopathies,Improvement of Synaptic Plasticity and Cognitive Function in RAS Pathway Disorders,volker.mall@kbo.de;volker.mall@kbo.de,volker.mall@kbo.de;volker.mall@kbo.de,Interventional,"Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). ",Phase 2,2018-04-11,2019-03-22,14,Recruiting,Technische Universität München,NULL,germany,Drug: Lovastatin;Drug: Lamotrigine,"
Inclusion Criteria:
- Group 1: NS, Group 2: NF1 (both genetically assured)
- Age >18 years
- Signed informed consent.
- Persons who are capable to give their consent and understand the aim and rationale of
the study. In case of doubts, an independent medical practitioner will evaluate the
capacity to consent.
- Male participants and female participants who are not capable of bearing children or
who use a method of contraception that is medically approved by the health authority
of the respective country.
Exclusion Criteria:
- Epilepsy
- Medication with known CNS effects
- Severe mental retardation
- Side effects during previous medication with and contraindications to LTG and/or LOV
and/or TMS
- Psychiatric diseases
- Previous history of allergic reactions with LTG and LOV medications
- Potentially unreliable patients
- Patients who are not suitable for the study in the opinion of the investigator
- Pregnancy (incl. positive urine pregnancy test)
- Persons who are incapable of giving consent or do not understand the aim or rationale
of the study.
",NULL,Long-term potentiation (LTP)-like plasticity measured with transcranial magnetic stimulation (TMS),Difference between the neuropsychological testing of attention (Test of attentional performance) after placebo and after medication (LTG and LOV);Differences in short interval cortical inhibition (SICI) after placebo and after medication (LTG and LOV),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2019-03-22,2018-04-11,2018-04-11,14,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2019,NA,TRUE,FALSE,TRUE
34832,NA,NA,EUCTR2015-005309-35,NCT: NA ICTRP: 2016-06-09 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no time frame (in register), no measure",4,NA,no time frame (in register),NCT: NA ICTRP: 1880 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-04-19,NA,2017-07-04,2021-11-30,Interventional,"Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ), in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1, 2 or 3.","A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis",Recruiting,Phase 3,1880,Anticipated,R-Pharm,"Adverse events (AEs); Serious AEs (SAEs) and AEs of Special Interest (AESIs);Adjusted incidence rates (IR) and event rates (ER);Clinically significant laboratory abnormalities;Changes in clinical laboratory parameters, vital sign measurements, and physical examination findings;Occurrence of any major adverse cardiac event (MACE);Incidence and/or titer of antibodies","American College of Rheumatology 20% (ACR20), ACR50, and ACR70 response;American College of Rheumatology 20% (ACR20), ACR50, and ACR70 response;Simplified Disease Activity Index (SDAI) ≤3.3 (remission);Proportion of subjects with Disease Activity Score 28-joint count (DAS28) low disease activity;Changes in DAS28 (CRP);Changes in Health Assessment Questionnaire-Disability Index (HAQ-DI);Improvement in HAQ-DI;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in SDAI and Clinical Disease Activity Index (CDAI);Responses for European League Against Rheumatism (EULAR) based on DAS28 (CRP);Changes in components of American College of Rheumatology (ACR) Criteria;Impact of ADAs to OKZ on subject safety and efficacy;Impact of ADAs to OKZ on subject safety and efficacy",2015-005309-35;CL04041024,"Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ), in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1, 2 or 3.","A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis",,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2017-02-07,2017-07-04,1880,Recruiting,R-Pharm,"Quintiles, Inc.;OCT Clinical Trials;Mene Research","united states;argentina;brazil;bulgaria;colombia;czechia;estonia;germany;hungary;korea, republic of;latvia;lithuania;mexico;poland;romania;russian federation;taiwan;united kingdom;argentina;brazil;bulgaria;colombia;czechia;estonia;germany;hungary;korea, republic of;latvia;lithuania;mexico;poland;romania;russian federation;taiwan;united kingdom;united states",Drug: Olokizumab 64 mg SC q4w;Drug: Olokizumab 64 mg SC q2w;Drug: Methotrexate,"
Inclusion Criteria:
Subjects may be enrolled in the study only if they meet all of the following criteria:
1. Subject must be willing and able to sign informed consent
2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3
core studies (CL04041022, CL04041023, or CL04041025).
3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or
=10 mg/week if there is documented intolerance to higher doses) during the core study
and plan to maintain the same dose and route of administration for additional 12 weeks
4. Subjects must be willing to take folic acid or equivalent throughout the study.
Exclusion Criteria:
1. Subject with any medically important condition in the core study (e.g., clinically
significant laboratory values, frequent AEs or SAEs, infection SAEs, and/or other
concurrent severe and/or uncontrolled medical condition) which would make this subject
unsuitable for inclusion in the open-label extension (OLE) study in the Investigator's
judgement.
2. Subject has evidence of active tuberculosis (TB)
3. Subject has planned surgery during the first 12 weeks of the OLE
4. Female subjects who are pregnant or who are planning to become pregnant during the
study or within 6 months of the last dose of study drug
5. Female subjects of childbearing who are not willing to use a highly effective method
of contraception during the study OR Male subjects with partners of childbearing
potential not willing to use a highly effective method of contraception during the
study.
6. Subject is unwilling or unable to follow the procedures outlined in the protocol
7. Other medical or psychiatric conditions, or lab abnormalities that may increase the
potential risk associated with study participation and administration of
investigational medicinal products (IMPs), or that may affect study results
interpretation and, as per Investigator's judgement, make the subject ineligible
The following restrictions may affect a subject's ability to participate in this study:
- Availability to attend visits according to the protocol within the allowed window
period
- Ability to perform self-administration of study drug and availability of caregiver to
administer study drug
- Concomitant medication restrictions as described in the Informed Consent Form and
protocol (water and concomitant medications are permitted) for at least 9 hours prior
to all study visits 8. Subject with a positive or repeated indeterminate
interferon-gamma release assay (IGRA) result at Week 22 of the core study
- Subjects may be enrolled in the OLE study if they fulfill all 3 of the following
criteria prior to the first dose of study treatment:
1. Active TB is ruled out by a certified TB specialist or pulmonologist who is
familiar with diagnosing and treating TB (as acceptable per local practice);
2. The subject starts prophylaxis for LTBI according to country-specific/Centers for
Disease Control and Prevention (CDC) guidelines (see Appendix 4 [Section 13.4])
(treatment with isoniazid for 6 months is not an appropriate
The Investigator (or designee) should review these restrictions with the subject during the
Screening Period to determine any potential challenges in the subject's ability to comply
with the protocol. Subjects not able to comply with the above mentioned restrictions should
not be enrolled into the study.
",NULL,"Adverse events (AEs); Serious AEs (SAEs) and AEs of Special Interest (AESIs);Adjusted incidence rates (IR) and event rates (ER);Clinically significant laboratory abnormalities;Changes in clinical laboratory parameters, vital sign measurements, and physical examination findings;Occurrence of any major adverse cardiac event (MACE);Incidence and/or titer of antibodies","American College of Rheumatology 20% (ACR20), ACR50, and ACR70 response;American College of Rheumatology 20% (ACR20), ACR50, and ACR70 response;Simplified Disease Activity Index (SDAI) =3.3 (remission);Proportion of subjects with Disease Activity Score 28-joint count (DAS28) low disease activity;Changes in DAS28 (CRP);Changes in Health Assessment Questionnaire-Disability Index (HAQ-DI);Improvement in HAQ-DI;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in patient-reported outcome scores;Changes in SDAI and Clinical Disease Activity Index (CDAI);Responses for European League Against Rheumatism (EULAR) based on DAS28 (CRP);Changes in components of American College of Rheumatology (ACR) Criteria;Impact of ADAs to OKZ on subject safety and efficacy;Impact of ADAs to OKZ on subject safety and efficacy",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-07-04,2017-02-07,2017-02-07,1880,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2017,NA,TRUE,FALSE,TRUE
35641,NA,NA,EUCTR2017-004768-37,NCT: NA ICTRP: 2018-05-28 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 662 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-08-06,NA,2018-10-18,2025-12-31,Interventional,Trial on the Effect of Isatuximab to Lenaliodomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7),A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma,"Active, not recruiting",Phase 3,662,Actual,University of Heidelberg Medical Center,MRD negativity after induction Treatment (comparison of arms IA and IB);Progression Free Survival (PFS) after second randomization (arms IIA and IIB),"to compare the four treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding Progression free survival (PFS);to compare all 4 treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding overall survival (OS) from time of 1.randomization;Overall survival from second randomization;Complete Response (CR) rates after induction therapy;Complete Response (CR) after high dose therapy;Complete Response (CR) during/after maintenance therapy;MRD negativity after high dose therapy;MRD negativity during and after maintenance therapy;Best response to treatment during the trial;PFS 2 (PFS after next line of therapy) from 2. randomization;Toxicity during induction and maintenance with respect to adverse events of CTC grade >3 (and specific adverse events of CTC grade > 2 as defined in the protocol and serious adverse events;Quality of Life Assessment;Pharmakokinetic analyses of Isatuximab in induction treatment of patients in Arm IB (selected sites only);Pharmakokinetic analyses of Isatuximab in maintenance treatment of patients in Arm IIB (selected sites only)",GMMG HD7,Trial on the Effect of Isatuximab to Lenaliodomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7),A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma,,,Interventional,Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 3,2018-07-24,2018-10-18,662,"Active, not recruiting",University of Heidelberg Medical Center,NULL,germany,Drug: Lenalidomide;Drug: Bortezomib;Drug: Dexamethasone;Drug: Isatuximab,"
Inclusion Criteria:
1. Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy
(diagnostic criteria (IMWG updated criteria (2014)1) see appendix IA. For some
patients systemic therapy may be required though these diagnostic criteria are not
fulfilled. In this case the GMMG study office has to be consulted prior to inclusion.)
2. Patient is eligible for high dose therapy and autologous stem cell transplantation.
3. Measurable disease, defined as any quantifiable monoclonal protein value, defined by
at least one of the following three measurements:2
- Serum M-protein = 10g/l (for IgA = 5g/l)
- Urine light-chain (M-protein) of = 200 mg/24 hours
- Serum FLC assay: involved FLC level = 10 mg/dl provided sFLC ratio is abnormal
4. Age 18 - 70 years inclusive
5. WHO performance status 0-2
6. Negative pregnancy test at inclusion (females of childbearing potential)
7. All patients must agree on the requirements regarding the lenalidomide pregnancy
prevention plan described in section 6. For all men and females of childbearing
potential: patients must be willing and capable to use adequate contraception during
the complete therapy.
8. All patients must
- agree to abstain from donating blood while taking lenalidomide and for 28 days
following discontinuation of lenalidomide therapy
- agree not to share study drug lenalidomide with another person and to return all
unused study drug to the investigator or pharmacist
9. Ability of patient to understand character and individual consequences of the clinical
trial
10. Provide written informed consent (must be available before enrolment in the trial)
Exclusion Criteria
1. Patient has known hypersensitivity (or contraindication) to dexamethasone, sucrose
histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any
of the components of study therapy that are not amenable to premedication with
steroids or H2 blockers that would prohibit further treatment with these agents.
2. Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
3. Plasma cell leukemia
4. Previous chemotherapy or radiotherapy during the past 5 years except local
radiotherapy in case of local myeloma progression. (Note: patients may have received a
cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy.)
Previous therapy due to smouldering myeloma may be acceptable. In this case the GMMG
study office has to be consulted prior to inclusion
5. Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction < 40%
6. Significant hepatic dysfunction (ASAT and/or ALAT = 3 times normal level and/or serum
bilirubin = 1.5 times normal level if not due to hereditary abnormalities as Gilbert's
disease), unless related to myeloma.
7. Patients with active or history of hepatitis B or C
8. HIV positivity
9. Patients with active, uncontrolled infections
10. Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min)
11. Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as
defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version
5.0)
12. Patients with a history of active malignancy during the past 5 years with the
exception of following malignancies after curative therapy: basal cell carcinoma of
the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ
malignancy
13. Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
14. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
15. Platelet count < 75 x 109/l
16. Haemoglobin < 8.0 g/dl, unless related to myeloma
17. Absolute neutrophil count (ANC) < 1.0 x 109/l (the use of colony stimulating factors
within 14 days before the test is not allowed)
18. Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l)
19. Unable or unwilling to undergo thromboprophylaxis
20. Pregnancy and lactation
21. Participation in other clinical trials. This does not include long-term follow-up
periods without active drug treatment of previous studies during the last 6 months.
22. Prisoners or subjects who are legally institutionalized, or those unwilling or unable
to comply with scheduled visits, drug administration plan, laboratory tests, other
study procedures, and study restrictions.
No patients will be allowed to enrol in this trial more than once.
-
",NULL,MRD negativity after induction Treatment (comparison of arms IA and IB);Progression Free Survival (PFS) after second randomization (arms IIA and IIB),"to compare the four treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding Progression free survival (PFS);to compare all 4 treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding overall survival (OS) from time of 1.randomization;Overall survival from second randomization;Complete Response (CR) rates after induction therapy;Complete Response (CR) after high dose therapy;Complete Response (CR) during/after maintenance therapy;MRD negativity after high dose therapy;MRD negativity during and after maintenance therapy;Best response to treatment during the trial;PFS 2 (PFS after next line of therapy) from 2. randomization;Toxicity during induction and maintenance with respect to adverse events of CTC grade >3 (and specific adverse events of CTC grade > 2 as defined in the protocol and serious adverse events;Quality of Life Assessment;Pharmakokinetic analyses of Isatuximab in induction treatment of patients in Arm IB (selected sites only);Pharmakokinetic analyses of Isatuximab in maintenance treatment of patients in Arm IIB (selected sites only)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-10-18,2018-07-24,2018-07-24,662,Interventional,FALSE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2018,NA,TRUE,FALSE,TRUE
30608,NA,NA,EUCTR2006-002221-23,NCT: NA ICTRP: 2006-10-25 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no measure,NA,NA,NA,NCT: NA ICTRP: 135 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,CT 4002 ,"An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients","An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients ",,,Interventional,"Controlled: yesRandomised: yesOpen: yesSingle blind: noDouble blind: noParallel group: yesCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: yesPlacebo: noOther: no",NULL,2007-01-19,2007-03-05,135,Not Recruiting,MediGene AG,NULL,france;germany,
Product Name: EndoTAG-1 (lipid complexed paclitaxel)
Product Code: MDG 09.101
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Paclitaxel
Current Sponsor code: MDG 09.100
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6.40-
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Paclitaxel
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
,"Inclusion criteria:
1. Histologically proven triple-receptor-negative metastatic or relapsed breast cancer
2. Minimum interval after the end of any previous taxane-containing chemotherapy regimen.
3. At least one tumor lesion measurable according to RECIST criteria
4. Gender: female
5. Age greater or equal to 18 years old
6. Negative pregnancy test (females of childbearing potential)
7. Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment
8. ECOG performance status 0, 1 or 2
9. Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
1. More than 1 previous chemotherapeutic treatment for metastatic
or relapsed disease.
2. Major surgery < 4 weeks prior to enrollment
3. Immunotherapy <2 weeks prior to enrollment
4. Severe pulmonary obstructive or restrictive disease
5. Uncontrolled inflammatory disease (autoimmune or infectious)
6. Clinically significant cardiac disease (NYHA stadium > 2)
7. Laboratory tests (hematology, chemistry) outside specified limits:
WBC < or equal 3 x 10 EXP 9/L
ANC < or equal 1.5 x 10 EXP 9/L
Platelets < or equal 100 x 10 EXP 9/L
Hb < or equal 9.0 g/dl (< or equal 5.6 mmol/l)
PTT/INR > 1.5 x ULN
AST or ALT > 2.5 x ULN
Alkaline Phosphatase > 2 x ULN
Total Bilirubin > 1.5 x ULN
8. Pregnancy or nursing status
9. Known positive HIV testing
10. Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations
11. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
12. Known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study)
13. History of active or significant neurological disorder and/or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
14. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
",Main Objective: Primary objective is to assess the efficacy of EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) as a rescue therapy for patients with triple receptor negative relapsed or metastatic breast cancer.;Secondary Objective: Secondary objective is to assess the safety and tolerability of EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in this patient population.;Primary end point(s): Primary efficacy endpoint is: 4-month progression free survival (PFS) rate calculated by the rate of patients in the modified intention-to-treat population (mITT) who show no progression of disease and are alive 16 weeks after first infusion of study drug.
,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-03-05,NA,2007-01-19,135,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,NA,FALSE,FALSE,TRUE
28918,NA,NA,ISRCTN03693000,NCT: NA ICTRP: 2007-09-27 DRKS: NA,1,0,"Registration mentions ""partial cross-over"" design, but this is not reported or did not take place",2,0,r,"NA; Age 18-65 (with exceptions for older patients) in register, 19-72 in article. ""Participants with mild depressive symptoms on antidepressant treatment can be included if there is a history of moderate or severe symptoms during the current depressive episode"" only mentioned in register",2,0,NA; maximum dose of Nortriptyline differs,5,0,NA; First primary outcome not reported,4,0,no AM; not reported,NCT: NA ICTRP: 1000 DRKS: NA,811,1,0,NA,NA,NA,NA,NA,NA,0,no outcome,ganzer Artikel,https://doi.org/10.1176/appi.ajp.2009.09070932,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-001723-38;EC Contract Ref.: LSHB-CT-2003-503428; EudraCT No.: 2004-001723-38,GENome-based therapeutic drugs for DEPression,GENome-based therapeutic drugs for DEPression ,,,Interventional,This is a randomised multi-centre partial cross-over trial designed to establish the genetic determinants of therapeutic response to two antidepressants with different mechanisms of action. (Screening),Not Applicable,2007-09-27,2004-01-01,1000,Completed,European Commission (Belgium),NULL,belgium;croatia;denmark;germany;italy;poland;slovenia;united kingdom,"
Participants without contraindications to study medications will be randomised to receive either escitalopram or nortriptyline orally for 12 weeks. In case of non-response or adverse reaction, the treatment is terminated and, unless contraindicated, the other medication is offered for another 12 weeks. The crossover can occur at week 12 or earlier if clinically indicated with no washout period between the two treatments. Participants with a history of adverse effect, non-response or contraindication to one of the study medications are included and non-randomly allocated to the other medication. All participants will be followed up weekly for 12 weeks with an additional follow-up at week 26 from the start of the last course of medication.
1. Escitalopram initiated at 10 mg daily and titrated to a target dose of 20 mg daily within the first two weeks if tolerated; it can be further increased to a maximum dose of 30 mg daily if clinically indicated
2. Nortriptyline initiated at 50 mg daily and titrated to a target dose of 100 mg daily within the first two weeks if tolerated; further increase to a maximum dose of 200 mg daily is possible if clinically indicated
Participants without contraindications to study medications will be randomised to receive either escitalopram or nortriptyline for 12 weeks. In case of non-response or adverse reaction, the treatment is terminated and, unless contraindicated, the other medication is offered for another 12 weeks. Participants with a history of adverse effect, non-response or contraindication to one of the study medications are included and non-randomly allocated to the other medication.
","Inclusion criteria:
1. A diagnosis of major depressive episode of at least moderate severity, as defined by the International Classification of Diseases, version 10 (ICD-10) or the Diagnostic and Statistical Manual of mental disorders - fourth edition (DSM-IV) and established in the Schedules for Clinical Assessment in Neuropsychiatry interview (SCAN version 2.1, World Health Organisation [WHO], 1999)
2. White European parentage
3. Aged 18 to 65 years
4. Participants with mild depressive symptoms on antidepressant treatment can be included if there is a history of moderate or severe symptoms during the current depressive episode
5. Individuals aged over 65 can be included if they are medically fit and not taking regular medication other than antidepressants
",Exclusion criteria:
1. Family history of bipolar affective disorder or schizophrenia in first-degree relatives
2. A personal history of hypomanic or manic episode
3. Schizophrenia
4. Mood incongruent psychotic symptoms
5. Primary substance misuse
6. Primary organic brain disease
7. Current treatment with an antipsychotic or a mood stabiliser
8. Pregnancy or lactation
9. Medical contraindications or a history of lack of efficacy or adverse reaction to both study medications
10. Previous adverse reactions or non-response to either escitalopram or citalopram are considered as contraindications to escitalopram
,"
1. 17-item Hamilton Depression Rating Scale (HDRS-17)
2. Montgomery-Asberg Depression Rating Scale (MADRS)
3. Beck Depression Inventory (BDI)
All primary hypotheses related to outcome and adverse reactions of medication will be based on the 8-week face-to-face assessment, controlling for the baseline values. These three measures will be integrated using Item Response Modelling.
","
1. Global Assessment Scale (GAS)
2. UKU side effects rating scale
3. Antidepressant side effect scale
4. Client Service Receipt Inventory (CSRI)
5. Temperament and Character Inventory - Revised (TCI-R)
6. Brief Life Events Questionnaire (BLEQ)
7. Sexual Functioning Questionnaire (SFQ)
Secondary analyses will include analysis of baseline data, and data up to week 12 and up to week 26. As there are many measures in this study and many time points, it is not possible to prestate all the secondary analyses that will be performed.
",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-01-01,NA,2007-09-27,1000,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2004,NA,FALSE,FALSE,FALSE
31516,NA,NA,EUCTR2007-007197-31,NCT: NA ICTRP: 2008-03-03 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,3,NA,"No time frame, AM",NA,NA,NA,NCT: NA ICTRP: 30 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2008-06-17,NA,2008-08-31,2009-09-30,Interventional,Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables,Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.,Completed,Phase 2,32,Actual,"Orion Corporation, Orion Pharma",24-h Holter reporting,,3001088,Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables,Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables and Cerebrovascular Reactivity in Patients With Recent Stroke or TIA.,;,;,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 2,2008-06-12,2008-08-20,32,Completed,"Orion Corporation, Orion Pharma",NULL,finland;germany;hungary;sweden;finland;germany;hungary;sweden,Drug: Levosimendan;Drug: Placebo,"
Inclusion Criteria:
- Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1
to 9 months before the screening visit.
Exclusion Criteria:
- Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection
- Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve
disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute
coronary event or angioplasty or any other major surgery within 1 month, any major
surgery during the planned study period
- History of life-threatening ventricular arrhythmia within 3 months.
- History of Torsades de Pointes (TdP) or family history of long QT-syndrome
- Heart rate (HR) < 50 or > 100 bpm.
- Systolic blood pressure (SBP) < 100 mmHg or > 180 mmHg, or diastolic blood pressure
(DBP) > 100 mmHg.
- Ventricular tachycardia.
- Episode of atrial fibrillation or atrial flutter lasting > 60 seconds.
- Second or third degree atrioventricular (AV) block.
- Potassium (K) < 3.7 mmol/l or > 5.5 mmol/l.
- Creatinine > 170 µmol/l or on dialysis.
- Blood haemoglobin <10 g/dl; clinically significant hepatic impairment.
",NULL,24-h Holter reporting,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-08-31,2008-06-12,2008-06-12,32,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2008,NA,TRUE,FALSE,TRUE
33492,NA,NA,EUCTR2012-002866-11,NCT: NA ICTRP: 2012-11-02 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 833 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2012-09-21,NA,2013-01-31,2015-11-30,Interventional,Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease,"Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease",Completed,Phase 3,891,Actual,TauRx Therapeutics Ltd,Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23);Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11);Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes,Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC);Change from Baseline on Mini-Mental Status Examination (MMSE);Change in expected decline of whole brain volume as measured by brain MRI,TRx-237-015,Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease,"Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 15-Month Trial of TRx0237 in Subjects With Mild to Moderate Alzheimer's Disease",NULL,NULL,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2012-09-14,2013-01-20,891,Completed,TauRx Therapeutics Ltd,NULL,"united states;australia;bulgaria;canada;croatia;germany;italy;korea, republic of;malaysia;poland;romania;russian federation;singapore;spain;taiwan;united kingdom;australia;bulgaria;canada;croatia;germany;italy;korea, republic of;malaysia;poland;romania;russian federation;singapore;spain;taiwan;united kingdom;united states",Drug: TRx0237 150 mg/day;Drug: TRx0237 250 mg/day;Drug: Placebo,"
Inclusion Criteria:
- Diagnosis of all cause dementia and probable Alzheimer's disease
- Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score
of 14-26 (inclusive)
- Age < 90 years
- Modified Hachinski ischemic score of = 4
- Females, if of child-bearing potential, must practice true abstinence or be competent
to use adequate contraception and agree to maintain this throughout the study
- Subject, and/or, in the case of reduced decision-making capacity, legally acceptable
representative(s) consistent with national law is/are able to read, understand, and
provide written informed consent
- Has one (or more) identified adult caregiver who is willing to provide written
informed consent for his/her own participation; is able to read, understand, and speak
the designated language at the study site; either lives with the subject or sees the
subject for =2 hours/day =3 days/week; agrees to accompany the subject to each study
visit; and is able to verify daily compliance with study drug
- If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of
Screening, the subject must have been taking such medication(s) for =3 months. The
dosage regimen must have remained stable for =6 weeks and it must be planned to remain
stable throughout participation in the study.
- Able to comply with the study procedures
Exclusion Criteria:
- Significant central nervous system (CNS) disorder other than Alzheimer's disease
- Significant focal or vascular intracranial pathology seen on brain MRI scan
- Clinical evidence or history of stroke, transient ischemic attack, significant head
injury or other unexplained or recurrent loss of consciousness =15 minutes
- Epilepsy
- Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar
disorder, or substance (including alcohol) related disorders
- Metal implants in the head (except dental), pacemaker, cochlear implants, or any other
non-removable items that are contraindications to MRI
- Resides in hospital or moderate to high dependency continuous care facility
- History of swallowing difficulties
- Pregnant or breastfeeding
- Glucose-6-phosphate dehydrogenase deficiency
- History of significant hematological abnormality or current acute or chronic
clinically significant abnormality
- Abnormal serum chemistry laboratory value at Screening deemed to be clinically
relevant by the investigator
- Clinically significant cardiovascular disease or abnormal assessments
- Preexisting or current signs or symptoms of respiratory failure
- Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine
disease (not adequately treated) and/or other unstable or major disease other than
Alzheimer's disease
- Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell
or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted
in complete freedom from disease for at least 2 years
- Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar
organic dyes, or any of the excipients
- Treatment currently or within 3 months before Baseline with any of the following
medications:
- Tacrine
- Clozapine, olanzapine (and there is no intent to initiate therapy during the
course of the study)
- Carbamazepine, primidone
- Drugs with a warning or precaution in the labeling about methemoglobinemia at
approved doses
- Current or prior participation in a clinical trial as follows:
- Clinical trial of a product for cognition within 3 months of Screening (unless
confirmed to have been randomized to placebo)
- A clinical trial of a drug, biologic, therapeutic device, or medical food in
which the last dose/administration was received within 28 days prior to Baseline
",NULL,Change from Baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23);Change from Baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11);Number of study participants who tolerate oral doses of TRx0237 as determined by safety parameter changes,Change from Baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC);Change from Baseline on Mini-Mental Status Examination (MMSE);Change in expected decline of whole brain volume as measured by brain MRI,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-01-31,2012-09-14,2012-09-14,891,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,NA,TRUE,FALSE,TRUE
30830,NA,NA,EUCTR2006-004774-27,NCT: NA ICTRP: 2006-11-23 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 3000 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-03-05,NA,2007-03-31,2009-07-31,Interventional,Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis),"An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications",Completed,Phase 3,3002,Actual,GlaxoSmithKline,Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47,Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77;Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77;Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77;Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77;Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77;Number of Any Adjudicated Bleeding Events at Days 47 and 77,ART108053,Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis),"An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). ",Phase 3,2007-03-02,2007-03-20,3002,Completed,GlaxoSmithKline,NULL,bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;united kingdom;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;united kingdom;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;united kingdom;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;united kingdom;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;bulgaria;czech republic;estonia;france;germany;greece;hungary;israel;italy;latvia;netherlands;poland;russian federation;slovakia;spain;switzerland;ukraine;united kingdom,Drug: Fondaparinux 2.5mg or placebo;Drug: Fondaparinux 2.5mg or placebo;Drug: Fondaparinux 2.5mg or placebo;Drug: Fondaparinux 2.5mg or placebo,"
Inclusion criteria:
- Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long
diagnosed by compression ultrasound.
Exclusion criteria:
- Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
- deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism
within last 6 months, treatment for cancer during last 6 months,
- anticoagulant medication for more than 48 hours prior to inclusion,
- need for oral non-steroidal anti-inflammatory drugs during the study, significant
bleeding event during past month,
- major surgery within last 3 months, low platelet count (below 100×109/L),
- kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing
potential not using reliable contraceptive method
;
Inclusion criteria:
- Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long
diagnosed by compression ultrasound.
Exclusion criteria:
- Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
- deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism
within last 6 months, treatment for cancer during last 6 months,
- anticoagulant medication for more than 48 hours prior to inclusion,
- need for oral non-steroidal anti-inflammatory drugs during the study, significant
bleeding event during past month,
- major surgery within last 3 months, low platelet count (below 100×109/L),
- kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing
potential not using reliable contraceptive method
;
Inclusion criteria:
- Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long
diagnosed by compression ultrasound.
Exclusion criteria:
- Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
- deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism
within last 6 months, treatment for cancer during last 6 months,
- anticoagulant medication for more than 48 hours prior to inclusion,
- need for oral non-steroidal anti-inflammatory drugs during the study, significant
bleeding event during past month,
- major surgery within last 3 months, low platelet count (below 100×109/L),
- kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing
potential not using reliable contraceptive method
;
Inclusion criteria:
- Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long
diagnosed by compression ultrasound.
Exclusion criteria:
- Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
- deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism
within last 6 months, treatment for cancer during last 6 months,
- anticoagulant medication for more than 48 hours prior to inclusion,
- need for oral non-steroidal anti-inflammatory drugs during the study, significant
bleeding event during past month,
- major surgery within last 3 months, low platelet count (below 100×109/L),
- kidney disease (Calculated creatinine clearance < 30 mL/min), woman of child-bearing
potential not using reliable contraceptive method
",NULL,Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47;Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47;Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47,Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77;Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77;Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77;Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77;Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77;Number of Any Adjudicated Bleeding Events at Days 47 and 77,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-03-31,2007-03-02,2007-03-02,3002,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,NA,TRUE,FALSE,TRUE
9077,NA,NA,NCT01651273,NCT: 2012-07-13 ICTRP: 2012-07-13 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: Actual 97 ICTRP: 97 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2012-07-27,NA,2012-11-30,2013-06-30,Interventional,A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia,"A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy",Terminated,Phase 1,97,Actual,Bristol-Myers Squibb,"Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy;Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy;Number and percent of subjects with potentially clinically significant changes in ECG parameter;Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)",Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data;Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data,2012-001946-17;CV201-008,A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia,"A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment",Phase 1,2012-07-13,2012-11-20,97,Terminated,Bristol-Myers Squibb,NULL,canada;germany;canada;germany,Drug: BMS-852927;Drug: BMS-852927;Drug: BMS-852927;Drug: Placebo,"
Inclusion Criteria:
- Men and women, aged =18 to =75
- Body mass index (BMI) = 40 kg/m2
- Primary hypercholesterolemia on a stable daily dose of a statin for = 6 weeks
- Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L)
Exclusion Criteria:
- Any significant acute medical illness, significant cardiovascular history
- Current or history of hepatic or hepatobiliary disease
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG or clinical laboratory determinations beyond
what is consistent with the target population
",NULL,"Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy;Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy;Number and percent of subjects with potentially clinically significant changes in ECG parameter;Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)",Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data;Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-11-30,2012-07-13,2012-07-13,97,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2012,NA,TRUE,FALSE,FALSE
29207,NA,NA,ISRCTN55261332,NCT: NA ICTRP: 2005-10-10 DRKS: NA,1,1,NA,2,1,NA,NA,1,1,no dosages,3,0,"no AM, time frame unclear; Primary outcome changed, reasons are given in the article",3,1,"no AM, no time frame",NCT: NA ICTRP: 231 DRKS: NA,330,1,0,NA,NA,no info,NA,NA,NA,0,no outcome,ganzer Artikel,https://doi.org/10.1016/s0140-6736(09)61828-6,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2004-001981-41;BALANCE 1,Bipolar Affective disorder: Lithium/ANti-Convulsant Evaluation, ,john.geddes@psych.ox.ac.uk,,Interventional,Randomised controlled trial (Treatment),NULL,2005-10-10,2002-07-01,231,Completed,University of Oxford (UK),NULL,france;germany;ireland;italy;united kingdom;united states of america,1. Lithium monotherapy
2. Valproate semisodium monotherapy
3. Lithium plus valproate semisodium combination therapy,"Inclusion criteria: For entry to the run-in phase:
1. Previous episode of mania (clinical diagnosis, guided by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] criteria) that merited treatment (whether or not treatment was provided)
2. Agreement between investigator and patient to commence/continue treatment to
prevent relapse
3. It is considered clinically reasonable to try combination treatment with lithium and valproate semisodium
For randomisation:
1. Uncertainty about which trial treatment would be best for the participant
2. Lithium plasma level 0.4 to 1.0 mmol/litre on stable dose of lithium
3. If valproate semisodium dose is less than 750 mg a day, the participant must have a valproic acid serum level of at least 50 µg/ml
4. The participant can tolerate the combination of lithium and valproate semisodium
5. Adherence during the run-in phase is judged satisfactory by the investigator","Exclusion criteria: 1. Maintenance treatment is considered unnecessary
2. A particular maintenance treatment is definitely indicated or contraindicated, or the
patient is unwilling to take one or other of the study treatments
3. A medical disorder or condition coexists which contraindicates either of the investigational drugs, e.g., pregnancy
4. The patient is not normally resident in the UK or is of no fixed abode","1. Hospital admission: the primary outcome will be the time to hospital admission during the scheduled randomised treatment period. Admission is a useful indicator of a severe relapse of illness because, since bed provision is now minimal, the clinical threshold for admission is high. Admission to hospital is a useful pragmatic outcome: the majority of patients and clinicians view admission as a negative event that an effective maintenance treatment would be expected to prevent. In certain sites, because some mental health services use intensive alternatives to hospital treatment, the primary outcome will need to be a comparable administrative event such as new attendance at a day patient facility or active home treatment. The appropriate primary outcome will be established with each site before the trial starts and, for the purposes of the trial, a proxy must be 7 days per week treatment at day hospital or 7 days per week home treatment or 24 hour admission to flats and hostel accommodation under regular staff supervision.
2. Concurrent use of adjunctive medication: although there is general agreement that admission to hospital is a clinically meaningful and measurable outcome, it is a somewhat insensitive measure of the less severe mood fluctuations that cause considerable disability in bipolar disorder. Furthermore, manic episodes are more likely than depressive episodes to result in hospital admission. The use of adjunctive antidepressant and antipsychotic medication and of mood stabilizers other than lithium and valproate semisodium will provide a measure of the occurrence of mood episodes that are not severe enough to lead to admission.","1. Global Assessment of Functioning Scale (GAF): the GAF is a brief scale of overall functioning of demonstrated reliability and validity that is used in routine clinical practice and in recent trials in bipolar disorder. The GAF will be used to provide an overall estimate of functioning during the previous year.
2. Deliberate self-harm: deliberate self-harm of suicidal intent (including suicide) is a common outcome in bipolar disorder and of obvious clinical importance. There is observational evidence that lithium therapy reduces the incidence of suicide and it is important to measure this outcome, although it is unlikely that BALANCE will have sufficient power to detect a treatment effect reliably.
3. Quality of life: the EuroQol (EQ-5D) will be used to assess quality of life. This questionnaire has been used successfully in two contemporary trials in psychiatry - the ongoing NHS R&D CUtLASS trial of atypical antipsychotics and the recent MRC-funded trial of cognitive behaviour therapy in bipolar disorder.
4. Adverse events: patients have identified adverse events and side-effects as being one of the main negative aspects of long term medication. Valproate semisodium is a newly licensed drug in the UK and it is essential to record the occurrence of all adverse events.
5. Withdrawal from study treatment: withdrawal from allocated treatment is a useful and pragmatic, although non-specific, measure of the overall acceptability and efficacy of a drug
6. Adherence to study medication: adherence to maintenance treatment is frequently overlooked in maintenance trials in bipolar disorder but is essential for interpreting the trial results",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-07-01,NA,2005-10-10,231,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,TRUE,NA,TRUE,2002,NA,FALSE,FALSE,FALSE
35693,NA,NA,EUCTR2018-001124-20,NCT: NA ICTRP: 2018-06-07 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no AM,NCT: NA ICTRP: 60 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,GISG-17,"Efficacy of Olaratumab and Re-Treatment with Doxorubicin in anthracycline pretreated, advanced soft tissue sarcoma patients.","Efficacy of Olaratumab and Rechallenge with Doxorubicin in anthracycline pretreated, advanced soft tissue sarcoma patients.An exploratory phase-II study- The OlaReDo Phase II Trial - OlaReDo ",eickhoff.regina@ikf-khnw.de,eickhoff.regina@ikf-khnw.de,Interventional,"Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
",Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no,2018-06-07,2018-08-14,60,Not Recruiting,IKF Klinische Krebsforschung GmbH am Krankenhaus Nordwest,NULL,germany,
Trade Name: Lartruvo®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Olaratumab
CAS Number: 1024603-93-7
Other descriptive name: OLARATUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: CARDIOXANE®
Product Name: Dexrazoxan
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: DEXRAZOXANE
CAS Number: 24584-09-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Product Name: Doxorubicinhydrochlorid
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOXORUBICIN HYDROCHLORIDE
Other descriptive name: Doxorubicin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
,"Inclusion criteria:
1.Patients must have histologically confirmed soft tissue sarcoma (STS)
Note: Evidence of disease progression at study entry is required.
2.Treated in any order (neoadjuvant, adjuvant or for metastatic disease) with an anthracycline containing chemotherapy
(The participant may have had any number of prior systemic cytotoxic therapies for advanced/metastatic disease. All previous anticancer treatments must be completed = 3 weeks (21 days) prior to first dose of study drug.)
3.No progression on prior therapy with anthracyclines or within three months after stopping this therapy
4.Signed written informed consent
5.Men and women aged = 18 years
6.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7.Locally advanced (unresectable) or metastatic disease
8.Presence of measurable or non-measurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1, Eisenhauer et al., 2009)
9.Adequate haematologic, organ, and coagulation within 2 weeks (14 days) prior to enrollment:
•Absolute neutrophil count (ANC) = 1,500/mm3; G-CSF is not permitted within 2 weeks (14 days) prior to enrollment
•Platelet count = 100,000/mm3
•Creatinine clearance = 45 mL/min (calculated by using the Cockcroft-Gault formula (refer to study protocol Appendix 4)
•Total bilirubin = upper limit of normal (ULN). In patients with Gilbert’s Syndrome, total bilirubin should be < 3 mg/dL
•AST/ALT = 3.0 x upper limit of normal (ULN); in case of liver involvement, AST/ALT = 5.0 x are acceptable
•Haemoglobin = 9 g/dl. If haemoglobin <9 g/dl, blood transfusion is permitted. If haemoglobin cannot be enhanced to = 9 g/dl, patient cannot be included into the study
•International Normalized Ration (INR) = 1.5 or prothrombin time (PT) = 1.5 x ULN
•Partial thromboplastin time (PTT or aPTT) = 1.5 x ULN if not on anticoagulant therapy. For patients receiving anticoagulants, coagulation parameters within the intended or expected range for their therapeutic use are allowed.
•If routine urinalysis =2+ proteinuria, patient must have =1000 mg protein on a 24-hour urine, or urine protein/creatinine ratio =1 on spot urine
10.Left ventricular ejection fraction (LVEF) =50% assessed within 28 days prior to enrollment
11.Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment (refer to study protocol Appendix 3)
12.Females of child-bearing potential and males and must agree to use highly effective contraceptive precautions during the trial and up to 6 months following the last dose of study drug (refer to study protocol Appendix 3)
13.The participant has, in the opinion of the investigator, a life expectancy of at least 3 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
","Exclusion criteria:
1.Diagnosis of GIST or Kaposi sarcoma
2.Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis
3.Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation
4.The participant has symptomatic congestive heart failure (CHF), or severe cardiac arrhythmia
5.The participant has unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of enrollment
6.The participant has a QTcB interval calculated using Bazett's formula interval of >450 milliseconds (msec) for males and >470 msec for females on screening electrocardiogram (ECG)
7.Females who are pregnant or breastfeeding
8.Known allergy to any of the treatment components including a history of allergic reactions attributed to compounds of chemical or biological composition similar to olaratumab, dexrazoxane or doxorubicin
9.The participant has a known active fungal, bacterial, or viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required)
10.Known history of active bleeding (defined as within 14 days of first dose of study drug) or pathological condition that carries a high risk of bleeding (for example, tumor involving major vessels or known esophageal varices)
11.History of another primary cancer, with the exception of
i) curatively treated non-melanomatous skin cancer or ii) curatively treated cervical carcinoma in situ or iii) other primary nonhaematologic malignancies or solid tumor treated with curative intent, no known active disease and no treatment administered during the last 3 years prior to enrollment
12.Electively planned or required major surgery during the course of the clinical trial
13.Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
14.On-treatment participation in another clinical study in the period 30 days prior to start of study treatment and during the study
15.Legal incapacity or limited legal capacity.
16.Any condition that requires concomitant vaccination with yellow fever vaccine
","Main Objective: Progression-free survival rate after 3 months (PFSR3), assessed by applying RECIST 1.1;Secondary Objective: ·Progression-free survival (PFS)
·Objective response rate (ORR) (i.e. CR or PR)
·Disease control rate (DCR) (i.e. CR, PR or SD)
·Overall survival (OS)
·Assessment of adverse events according to CTCAE 4.03
·Study therapy discontinuation rate due to cardiac toxicity
(i.e. due to LVEF reduction by more than 20% or LVEF <45%)
;Primary end point(s): Progression-free survival rate after 3 months (PFSR3);Timepoint(s) of evaluation of this end point: 3 months from the first dosing date of any study medication ","Secondary end point(s): Safety parameters:
·Olaratumab plus doxorubicin treatment and dosage used
·Treatment duration (number of cycles)
·General description of grade 3/4 adverse events
·Reason for discontinuation of treatment
·Discontinuation rate due to cardiac toxicity
(i.e. due to LVEF reduction by more than 20% or LVEF <45%)
Efficacy parameters:
•PFS:
PFS is defined as the time from the first dosing date of any study medication to the date of the first objectively documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who did not progress or die will be censored on the date of their last tumor assessment. Subjects who did not have any on study tumor assessments and did not die will be censored on the first dosing date of study medication. Subjects who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy.
•ORR: Objective Response Rate (ORR) defined as the number and percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy or death date, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination.
•DCR: Disease Control Rate (DCR) defined as the number and percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD), recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy or death date, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the DCR determination.
•OS: OS is defined as the time from date of the first dosing date of any study medication to the date of death (due to any cause). Subjects who are alive will be censored at the last known alive dates.
;Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated at the end of study",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2018-08-14,NA,2018-06-07,60,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2018,NA,FALSE,FALSE,TRUE
31025,NA,NA,EUCTR2007-000128-42,NCT: NA ICTRP: 2008-06-02 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,no dosage,4,NA,no AM,NA,NA,NA,NCT: NA ICTRP: 456 DRKS: NA,NA,1,0,NA,NA,"unclear who is blinded, because trial is registered as non-open",NA,NA,NA,0,no intervention,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,HIT-HGG-2007," International cooperative Phase II trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children = 3 years and adolescents < 18 years. - HIT-HGG-2007"," International cooperative Phase II trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children = 3 years and adolescents < 18 years. - HIT-HGG-2007 ",christof.kramm@med.uni-goettingen.de,christof.kramm@med.uni-goettingen.de,Interventional,"
Controlled: yes
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: historical control group: patients from HIT-GBM-C and –D
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: historical control group: patients from HIT-GBM-C and –D
", Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no,2008-06-02,2009-03-19,456,Not Recruiting,Martin-Luther-University Halle-Wittenberg,NULL,austria;germany,"
Trade Name: Temodal
Product Name: Temozolomide
Pharmaceutical Form: Capsule, hard
","Inclusion criteria:
•Newly diagnosed, previously untreated high grade glioma with central neuropathological review including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic mixed glioma/anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV)
•Newly diagnosed, previously untreated diffuse intrinsic pontine glioma of all tumour grades or without histology when confirmed by central neuroradiological review
•Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuropathological review and neuroradiological review
•Patient aged 3 years and older but under 18 years at time of diagnosis
•Written informed consent of the patient and/or the patient’s parents or legal guardian according to national laws
Are the trial subjects under 18? yes
Number of subjects for this age range: 456
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
•Pre-treatment differing from study protocol
•Known hypersensitivity or contraindication to study drugs and/or dacarbazine
•Prior chemotherapy or radiotherapy which prevents adequate performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary malignant glioma after a previous malignant brain tumour, e.g. medulloblastoma, supratentorial PNET. If previous treatment does not prevent the adequate performance of the outlined treatment protocol patients with secondary malignant glioma will be eligible for the present trial.
•Other (simultaneous) malignancies
•Pregnancy and / or lactation
•Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)
•Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
•Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism)
•Severe concomitant diseases (e.g. immune deficiency syndrome)
•Known HIV positivity
•Country-specifically very young patients may be excluded to comply with national laws or formal insurance requirements
","Main Objective: Is treatment with temozolomide efficacious? Treatment is considered to be efficacious if the probability for no event within the first 6 months after diagnosis” is not markedly inferior in comparison with the corresponding 6-months EFS-rates of the historical control group which was defined from patients of cohorts HIT-GBM-C and –D. That means that the probability for no event within the first 6 months after diagnosis” is not = 46% for patients with a pontine tumour and not = 53% for patients with a non-pontine tumour. (6-months EFS-rates of historical control group from HIT-GBM-C+D were: 51% for patients with a pontine tumour, 58% for patients with a non-pontine tumour).;
Secondary Objective: 1.Do the overall survival (OS) and event-free survival (EFS) of patients of the HIT-HGG-2008 trial differ from the OS / EFS of patients of the historical control groups (HIT-GBM-C and -D)?
2. Does the HIT-HGG-2008 treatment lead to different toxicity rates in comparison to the historical control group (HIT-GBM-C and -D)?
3. Has the methylation of the O6-MGMT gene promoter within the primary tumour an influence on the EFS?
4. Do the clinical parameters (tumour location (ICDO classification), tumour grading and centrally reviewed histology, extent of tumour resection, genetic syndromes, secondary malignancies, age at diagnosis, gender, and relapse treatment within HIT-HGG-2008) have an influence on EFS or OS?
5. Is there an association between these clinical parameters and the affiliation to one of the two patient groups HIT-HGG-2008 and HIT-GBM-C/-D?
;
Primary end point(s): Event-status 6 months after diagnosis: event / no event (i.e. by magnetic resonance imaging). An event” is defined as
•progression/relapse of disease
•diagnosis of a secondary malignancy
•death of any cause.
We assume that each patient will be observed at least 6 months after diagnosis.
",NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-03-19,NA,2008-06-02,456,Interventional,FALSE,TRUE,NA,NA,TRUE,TRUE,FALSE,TRUE,NA,TRUE,2009,NA,FALSE,FALSE,TRUE
31015,NA,NA,EUCTR2007-000010-36,NCT: NA ICTRP: 2007-08-03 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 48 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,M/34273/25;M/34273/25,"A multiple dose, double-blind, double-dummy, 3 period cross-over, placebo controlled clinical trial to assess the efficacy and safety of once daily inhaled aclidinium bromide 200 µg given either in the morning or in the evening in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD).","A multiple dose, double-blind, double-dummy, 3 period cross-over, placebo controlled clinical trial to assess the efficacy and safety of once daily inhaled aclidinium bromide 200 µg given either in the morning or in the evening in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD). ",;,;,Interventional,"Controlled: yesRandomised: yesOpen: noSingle blind: Double blind: yesParallel group: noCross over: yesOther: yesOther trial design description: Double-DummyIf controlled, specify comparator, Other Medicinial Product: noPlacebo: yesOther: no",NULL,2007-08-03,2007-10-18,48,Not Recruiting,"Laboratorios Almirall, S.A.",NULL,united kingdom;germany;united kingdom;germany,
Product Name: Aclidinium Bromide
Product Code: LAS34273
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Aclidinium Bromide
CAS Number: 320345-99-1
Current Sponsor code: LAS34273
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use
;
Product Name: Aclidinium Bromide
Product Code: LAS34273
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Aclidinium Bromide
CAS Number: 320345-99-1
Current Sponsor code: LAS34273
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use
,"Inclusion criteria:
For inclusion and randomisation in the trial, patients must meet each of the following criteria:
1. Males and non-pregnant, non-lactating females aged = 40. Women of childbearing potential are allowed to enter the trial ONLY if they use one medically approved (i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at the screening visit.
2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction.
3. Patients with a post salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value (i.e., 30% = 100xobserved post-salbutamol FEV1/ predicted FEV1 <80%)
4. Post-salbutamol FEV1/FVC < 70% at screening visit (i.e,. 100xpost-salbutamol FEV1/FVC < 70%).
5. Current, or ex-cigarette smokers with a smoking history of at least 10 pack-years.
Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ¸ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-years history). Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.
6. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;Inclusion criteria:
For inclusion and randomisation in the trial, patients must meet each of the following criteria:
1. Males and non-pregnant, non-lactating females aged = 40. Women of childbearing potential are allowed to enter the trial ONLY if they use one medically approved (i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year post-menopausal or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at the screening visit.
2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines: (http://www.goldcopd.com) and stable airway obstruction.
3. Patients with a post salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value (i.e., 30% = 100xobserved post-salbutamol FEV1/ predicted FEV1 <80%)
4. Post-salbutamol FEV1/FVC < 70% at screening visit (i.e,. 100xpost-salbutamol FEV1/FVC < 70%).
5. Current, or ex-cigarette smokers with a smoking history of at least 10 pack-years.
Pack-years are calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person has smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ¸ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-years history). Patients smoking other tobacco types will not be allowed, unless they meet the cigarette criterion as well.
6. Patients who are eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained to them.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
Patients randomised into the trial must not present any of the following conditions:
1. History or current diagnosis of asthma, allergic rhinitis or atopy.
2. Eosinophil count = 600 cells/mm3.
3. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks prior to the screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening period will be discontinued from the trial prior to randomisation.
4. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
5. Use of long-term oxygen therapy (= 15 hours/day).
6. Clinically significant respiratory conditions defined as:
· Known active tuberculosis.
· History of interstitial lung or pulmonary thromboembolic disease.
· Pulmonary resection during the past 12 months.
· History of life-threatening COPD.
· History of any bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
· Patients who in the investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial. Patients on a stable pulmonary rehabilitation program prior to entry and anticipated to be stable throughout the study can be enrolled.
· Lung cancer
7. Clinically significant cardiovascular conditions defined as:
·Myocardial infarction during the last 6 months.
·Unstable arrhythmia which has required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months.
· Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
8. Patients for whom the use of anticholinergic drugs is contraindicated: those with a known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
9. Patients with any other serious or uncontrolled physical or mental dysfunction which at the discretion of the investigator could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period.
10. QTc [calculated according to Bazett’s formula (QTc=QT/RR1/2) above 470 milliseconds in any of the ECGs performed at screening visit or at visit 1 (Day -1).
11. Patients who can not perform repeatable spirometry attempts at the screening visit.
12. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
13. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
14. Clinically relevant abnormalities laboratory, ECG parameters (other than QTc), or physical examination results at the screening evaluation that in the investigator’s opinion, preclude study participation.
15. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication (see section 10.3.2).
16. Patients with a history of drug and/or alcohol ab;Exclusion criteria:
Patients randomised into the trial must not present any of the following conditions:
1. History or current diagnosis of asthma, allergic rhinitis or atopy.
2. Eosinophil count = 600 cells/mm3.
3. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks prior to the screening visit. Patients who develop a respiratory tract infection or exacerbation during the screening period will be discontinued from the trial prior to randomisation.
4. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
5. Use of long-term oxygen therapy (= 15 hours/day).
6. Clinically significant respiratory conditions defined as:
· Known active tuberculosis.
· History of interstitial lung or pulmonary thromboembolic disease.
· Pulmonary resection during the past 12 months.
· History of life-threatening COPD.
· History of any bronchiectasis secondary to respiratory diseases others than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc).
· Patients who in the investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial. Patients on a stable pulmonary rehabilitation program prior to entry and anticipated to be stable throughout the study can be enrolled.
· Lung cancer
7. Clinically significant cardiovascular conditions defined as:
·Myocardial infarction during the last 6 months.
·Unstable arrhythmia which has required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months.
· Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association.
8. Patients for whom the use of anticholinergic drugs is contraindicated: those with a known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
9. Patients with any other serious or uncontrolled physical or mental dysfunction which at the discretion of the investigator could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period.
10. QTc [calculated according to Bazett’s formula (QTc=QT/RR1/2) above 470 milliseconds in any of the ECGs performed at screening visit or at visit 1 (Day -1).
11. Patients who can not perform repeatable spirometry attempts at the screening visit.
12. History of untoward reactions to inhaled anticholinergics, sympathomimetic amines or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
13. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
14. Clinically relevant abnormalities laboratory, ECG parameters (other than QTc), or physical examination results at the screening evaluation that in the investigator’s opinion, preclude study participation.
15. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication (see section 10.3.2).
16. Patients with a history of drug and/or alcohol ab","Main Objective: To assess whether the time of dosing (a.m. or p.m.) at steady state influences the bronchodilator response of aclidinium bromide compared to placebo in patients with moderate to severe COPD.;Secondary Objective: To further evaluate the safety and tolerability of multiple doses of aclidinium bromide in moderate to severe COPD patients.;Primary end point(s): Efficacy variables:
Primary efficacy variable:
• Change from baseline in the trough FEV1 after 6 days of treatment.
Secondary efficacy variables:
• Change from baseline in the trough FVC after 6 days of treatment.
• Change from baseline in the trough IC after 6 days of treatment.
• Change from baseline in the FEV1 and FVC at all time-points after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen.
• Change from baseline in the IC at all time-points after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen.
• Change from baseline in the peak FEV1 and FVC after 7 days of treatment.
• Change from baseline in normalised FEV1 and FVC AUC0-24 after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen.
• Change from baseline in normalised FEV1 and FVC AUC0-12 after 7 days of treatment.
• Change from baseline in normalised FEV1 and FVC AUC12-24 after 7 days of treatment in the a.m. regimen and after 6 days of treatment in the p.m. regimen.
• Use of as needed” daily rescue medication (number of salbutamol puffs, as recorded by the patient during the treatment period).
Safety variables:
• Adverse Events (AEs).
• Serious Adverse Events (SAEs).
• 12-lead ECG parameters.
• Blood pressure parameters.
• Laboratory parameters (standard haematology, biochemistry and urinalysis).
• Physical examination.
Other variables:
• Use of concomitant medication.
• Number (%) of withdrawals and reasons for withdrawal.;Main Objective: To assess whether the time of dosing (a.m. or p.m.) at steady state influences the bronchodilator response of aclidinium bromide compared to placebo in patients with moderate to severe COPD.;Secondary Objective: To further evaluate the safety and tolerability of multiple doses of aclidinium bromide in moderate to severe COPD patients.;Primary end point(s): Efficacy variables:
Primary efficacy variable:
• Change from baseline in the trough FEV1 after 6 days of treatment.
Secondary efficacy variables:
• Change from baseline in the trough FVC after 6 days of treatment.
• Change from baseline in the trough IC after 6 days of treatment.
• Change from baseline in the FEV1 and FVC at all time-points after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen.
• Change from baseline in the IC at all time-points after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen.
• Change from baseline in the peak FEV1 and FVC after 7 days of treatment.
• Change from baseline in normalised FEV1 and FVC AUC0-24 after 7 days of treatment in the a.m. regimen and after 6-7 days of treatment in the p.m. regimen.
• Change from baseline in normalised FEV1 and FVC AUC0-12 after 7 days of treatment.
• Change from baseline in normalised FEV1 and FVC AUC12-24 after 7 days of treatment in the a.m. regimen and after 6 days of treatment in the p.m. regimen.
• Use of as needed” daily rescue medication (number of salbutamol puffs, as recorded by the patient during the treatment period).
Safety variables:
• Adverse Events (AEs).
• Serious Adverse Events (SAEs).
• 12-lead ECG parameters.
• Blood pressure parameters.
• Laboratory parameters (standard haematology, biochemistry and urinalysis).
• Physical examination.
Other variables:
• Use of concomitant medication.
• Number (%) of withdrawals and reasons for withdrawal.",NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-10-18,NA,2007-08-03,48,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,NA,FALSE,FALSE,TRUE
29162,NA,NA,ISRCTN45403612,NCT: NA ICTRP: 2006-02-02 DRKS: NA,1,NA,NA,1,NA,NA,NA,1,NA,NA,2,NA,"no AM, no metric, no time frame",1,NA,"no AM, no time frame, no metric, no measure",NCT: NA ICTRP: 10 DRKS: NA,NA,1,0,NA,NA,no info,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,GAMBRO 99/03,Kinetics of solute removal with on-line hemodiafiltration: influence of duration and frequency of treatment, ,,,Interventional,Four-period crossover (Treatment),NULL,2006-02-02,2000-01-01,10,Completed,Gambro Dialysatoren GmbH (Germany),NULL,germany,"Modification of treatment mode, frequency, drawing and analysis of blood samples",Inclusion criteria: 1. Stable patients with renal end stage disease being on hemodialysis for at least six months
2. Residual urine volume less than 200 ml per day
3. Ages betweeen 18 and 75 years
4. Body dry weight between 60 and 80 kg
5. Written consent
6. Well functioning vascular access,"Exclusion criteria: 1. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
2. Miscellaneous acute or chronic infections
3. Known coagulation disturbances
4. Known incompliance with respect to fluid restriction",Blood concentrations of small and large molecular weight uremic solutes,Modelling of solute kinetics,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2000-01-01,NA,2006-02-02,10,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2000,NA,FALSE,FALSE,FALSE
28802,NA,NA,ISRCTN66123742,NCT: NA ICTRP: 2008-07-31 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,Not clear to this assessor what the post-OP directives are. Also two interventions are registered but refer to the same arm and are conducted in sequence. No description of control arm.,3,NA,"no AM, no measure",4,NA,no AM,NCT: NA ICTRP: 40 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,N/A,Haemodynamic protocols in traumatology,"The feasability, the implementation and the influence on patient outcome of an intra-operative goal-directed haemodynamic protocol and post-operative directives in comparision to conventional treatment in cemented and uncemented hemiarthroplasty of femoral neck fractures: a pilot study ",claudia.spies@charite.de,,Interventional,Prospective randomised double-blinded two-arm single-centre trial (Treatment),Not Applicable,2008-07-31,2008-06-15,40,Completed,Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany),NULL,germany,1. Targeted-volume application guided by oesophageal Doppler; only during the primary operation
2. Post-operative directives versus conventional volume application; only during the time the patient is in the intensive care unit (ICU)/intermediate care unit (IMCU) to finish post-operative directives (POD) 0 on the first post-operative day one at 8 am.
The follow-up will be up hospital discharge or up to the 30th post-operative day. The patient will be contacted 90 days after the operation.,"Inclusion criteria: 1. Aged greater than or equal to 60 years, either sex
2. Written informed consent of the patient
3. Anamnestically two or more years post-menopausal or surgically sterile
4. Patients with dislocated femoral neck fracture which is not older than 24 hours and will be operated within the next 24 hours","Exclusion criteria: 1. Aged less than 60 years
2. No written consent from patient
3. Inability to communicate safely in German
4. Unwillingness to allow storage and sharing of anonymised disease data in the context of the clinical study
5. Simultaneous participation of the patient in another study or having been in a study which was terminated less than one month ago and not planned within the next three months
6. Accommodation in an institution due to an official or judicial order
7. Members of staff of the Charité
8. Advanced disease of the oesophagus of nasopharyngeal cavity
9. Operations in the area of the oesophagus or nasopharynx within the last two months
10. Liver disease (Child B or C cirrhosis, End-Stage Liver Disease [MELD] score greater than 10)
11. Condition after acute or chronic pancreatitis
12. History of bleeding tendency
13. Von Willebrands disease
14. Neurological or psychiatric disease
15. Chronic heart failure New York Heart Association (NYHA) class IV
16. American Society of Anaesthesiologists (ASA) classification greater than III
17. Renal failure (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
18. Existence of a pulmonary oedema in the preoperative chest x-ray
19. Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions
20. History of intracranial haemorrhage within one year","Peri-operative incidence of delirium, examined the whole time during the hospital stay of the patient.","1. Frequency of alcohol and drug abuse in patients undergoing femoral neck repair, examined directly after inclusion of the patient in the study
2. Peri-operative incidence of pulmonary, renal and cardiovascular dysfunction and of protocol violations, examined the whole time during the hospital stay of the patient
3. Post-operative incidence of infections, examined the whole time during the hospital stay of the patient
4. Quality of life (measured using the EuroQoL instrument), examined after inclusion in the study and 90 days after the operation",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-06-15,NA,2008-07-31,40,Interventional,TRUE,TRUE,NA,NA,FALSE,FALSE,FALSE,TRUE,NA,TRUE,2008,NA,FALSE,FALSE,FALSE
33004,NA,NA,EUCTR2011-001112-53,NCT: NA ICTRP: 2011-11-21 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 2000 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,NA,NA,kein Artikel,NA,NA,2011-12-16,NA,2012-01-31,2016-12-31,Interventional,TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer,"A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers",Terminated,Phase 3,1015,Actual,Amgen,Progression free survival,Incidence of anti-AMG 386 antibody formation;Correlation of serum biomarkers with measures of response;Patient reported ovarian cancer-specific symptoms and health related quality of life;Patient reported status as measured by the EuroQOL (EQ-5D);AMG 386 exposure-response relationships for PFS and OS;Pharmacokinetics of AMG 386 (Cmax and Cmin);Overall survival (OS);Incidence of adverse events and significant laboratory abnormalities,TRINOVA-3 20101129/ENGOT-ov2;20101129,TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer,"A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers",;;;;,;;;;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). ",Phase 3,2011-09-29,2012-01-20,1015,Terminated,Amgen,NULL,"united states;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;united states;united states;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;united states;united states;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;united states;united states;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;united states;united states;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;austria;belgium;canada;denmark;germany;greece;hong kong;italy;japan;korea, republic of;netherlands;russian federation;spain;united states",Drug: AMG 386;Drug: Paclitaxel;Drug: AMG 386 Placebo;Drug: Carboplatin;Drug: AMG 386;Drug: Paclitaxel;Drug: AMG 386 Placebo;Drug: Carboplatin;Drug: AMG 386;Drug: Paclitaxel;Drug: AMG 386 Placebo;Drug: Carboplatin;Drug: AMG 386;Drug: Paclitaxel;Drug: AMG 386 Placebo;Drug: Carboplatin,"
Inclusion Criteria:
- Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian,
primary peritoneal or fallopian tube cancer with an indication for first-line
treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma,
mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma,
mucinous or neuroendocrine histology are excluded
- Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian,
primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
- Subjects with FIGO Stage IIIC or IV disease must either:
- Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within
12 weeks prior to randomization or
- Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG
386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube
cancer
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer
- Previous abdominal and/or pelvic external beam radiotherapy
- History of central nervous metastasis
- History of arterial or venous thromboembolism within 12 months prior to randomization
- Clinically significant cardiovascular disease within 12 months prior to randomization
;
Inclusion Criteria:
- Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian,
primary peritoneal or fallopian tube cancer with an indication for first-line
treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma,
mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma,
mucinous or neuroendocrine histology are excluded
- Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian,
primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
- Subjects with FIGO Stage IIIC or IV disease must either:
- Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within
12 weeks prior to randomization or
- Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG
386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube
cancer
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer
- Previous abdominal and/or pelvic external beam radiotherapy
- History of central nervous metastasis
- History of arterial or venous thromboembolism within 12 months prior to randomization
- Clinically significant cardiovascular disease within 12 months prior to randomization
;
Inclusion Criteria:
- Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian,
primary peritoneal or fallopian tube cancer with an indication for first-line
treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma,
mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma,
mucinous or neuroendocrine histology are excluded
- Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian,
primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
- Subjects with FIGO Stage IIIC or IV disease must either:
- Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within
12 weeks prior to randomization or
- Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG
386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube
cancer
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer
- Previous abdominal and/or pelvic external beam radiotherapy
- History of central nervous metastasis
- History of arterial or venous thromboembolism within 12 months prior to randomization
- Clinically significant cardiovascular disease within 12 months prior to randomization
;
Inclusion Criteria:
- Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian,
primary peritoneal or fallopian tube cancer with an indication for first-line
treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma,
mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma,
mucinous or neuroendocrine histology are excluded
- Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian,
primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
- Subjects with FIGO Stage IIIC or IV disease must either:
- Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within
12 weeks prior to randomization or
- Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG
386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube
cancer
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
Exclusion Criteria:
- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer
- Previous abdominal and/or pelvic external beam radiotherapy
- History of central nervous metastasis
- History of arterial or venous thromboembolism within 12 months prior to randomization
- Clinically significant cardiovascular disease within 12 months prior to randomization
",NULL,Progression free survival;Progression free survival;Progression free survival,Overall survival (OS);Incidence of adverse events and significant laboratory abnormalities;Pharmacokinetics of AMG 386 (Cmax and Cmin);Incidence of anti-AMG 386 antibody formation;Patient reported ovarian cancer-specific symptoms and health related quality of life;Patient reported status as measured by the EuroQOL (EQ-5D);AMG 386 exposure-response relationships for PFS and OS;Correlation of serum biomarkers with measures of response,NCT01493505; 20101129; TRINOVA-3 20101129/ENGOT-ov2,2013-05-07,no,Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer; Malignant neoplasm of ovary; Malignant neoplasm: Fallopian tube,Arm 1 Drug: AMG 386; Arm 2 Drug: Paclitaxel; Arm 3 Drug: AMG 386 Placebo; Arm 4 Drug: Carboplatin,Interventional,Randomized controlled trial,Blinded,Placebo|Active control,Parallel,III,- Progression free survival; time frame: 3 years
,"- Overall survival (OS); time frame: 5 years
- Incidence of adverse events and significant laboratory abnormalities; time frame: 4 years
- Pharmacokinetics of AMG 386 (Cmax and Cmin); time frame: 1 year; pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
- Incidence of anti-AMG 386 antibody formation; time frame: 4 years; pre-dose weeks 1, 10, 19
- Patient reported ovarian cancer-specific symptoms and health related quality of life; time frame: 4 years
- Patient reported status as measured by the EuroQOL (EQ-5D); time frame: 4 years
- AMG 386 exposure-response relationships for PFS and OS; time frame: 4 years
- Correlation of serum biomarkers with measures of response; time frame: 4 years
","United States; Austria; Belgium; Canada; Denmark; Germany; Greece; Hong Kong; Italy; Japan; Korea, Republic of; Netherlands; Russian Federation; Spain",[---]* Berlin; [---]* Dresden; [---]* Düsseldorf; [---]* Düsseldorf; [---]* Erlangen; [---]* Essen; [---]* Essen; [---]* Frankfurt am Main; [---]* Frankfurt am Main; [---]* Freiburg; [---]* Hamburg; [---]* Hannover; [---]* Hannover; [---]* Kiel; [---]* Konstanz; [---]* Leipzig; [---]* Ludwigsburg; [---]* München; [---]* München; [---]* München,2012-01-31,NA,2000,NA,"- Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian,
primary peritoneal or fallopian tube cancer with an indication for first-line
treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma,
mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma,
mucinous or neuroendocrine histology are excluded
- Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian,
primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
- Subjects with FIGO Stage IIIC or IV disease must either:
- Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer
within 12 weeks prior to randomization or
- Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG
386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian
tube cancer
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal and hepatic function
","- Prior use of any anticancer therapy or experimental therapy for epithelial ovarian,
primary peritoneal or fallopian tube cancer
- Previous abdominal and/or pelvic external beam radiotherapy
- History of central nervous metastasis
- History of arterial or venous thromboembolism within 12 months prior to randomization
- Clinically significant cardiovascular disease within 12 months prior to randomization
","A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers","Recruiting complete, follow-up continuing",Amgen; Amgen; Amgen,[---]*; [---]*; [---]*,Arm 1 Drug: AMG 386; Arm 2 Drug: Paclitaxel; Arm 3 Drug: AMG 386 Placebo; Arm 4 Drug: Carboplatin,2012-01-31,2011-09-29,2011-09-29,1015,Interventional,FALSE,FALSE,TRUE,FALSE,TRUE,TRUE,FALSE,FALSE,FALSE,FALSE,2012,NA,TRUE,TRUE,TRUE
33759,NA,NA,EUCTR2013-001517-32,NCT: NA ICTRP: 2013-07-04 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 350 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,K-877-201;2013-001517-32-SE,To find a safe and effective dose of K-877 for targeted patients,A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels ,ysenko@kowa.co.uk,ysenko@kowa.co.uk,Interventional,"Controlled: yesRandomised: yesOpen: noSingle blind: noDouble blind: yesParallel group: yesCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: noPlacebo: yesOther: noNumber of treatment arms in the trial: 7",NULL,2013-07-26,2014-01-13,350,Not Recruiting,Kowa Research Europe,NULL,hungary;czech republic;poland;denmark;russian federation;netherlands;germany;united kingdom;sweden,
Product Code: K-877
Pharmaceutical Form: Film-coated tablet
CAS Number: 848259-27-8
Current Sponsor code: K-877
Other descriptive name: K-877
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: K-877
Pharmaceutical Form: Film-coated tablet
CAS Number: 848259-27-8
Current Sponsor code: K-877
Other descriptive name: K-877
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: K-877
Pharmaceutical Form: Film-coated tablet
CAS Number: 848259-27-8
Current Sponsor code: K-877
Other descriptive name: K-877
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
,"Inclusion criteria:
Patients who meet the following criteria at screening will be eligible to participate in the study:
1. Able to understand and comply with study procedures and give written informed consent
2. Aged>=18 years
3. Have no clinically significant abnormal findings on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory profiles of both blood and urine that would impair participation or safety in the trial or clinically relevant abnormal findings that in the opinion of the investigator could interfere with the objectives of the study or the safety of the patient
4. After treatment with stable statin therapy for at least 12 weeks prior to screening, have a screening LDL-C of no more than 10 mg/dL (0.259 mmol/L) above the NCEP ATP III target (see Note 2 below):
? - LDL-C<70 mg/dL (1.81 mmol/L) or <100 mg/dL (2.59 mmol/L) for patients with coronary heart disease (CHD) or CHD equivalent
? - LDL-C<130 mg/dL (3.36 mmol/L) for patients with multiple risk factors
? - LDL-C<160 mg/dL (4.14 mmol/L) for patients with 0-1 risk factor
Note 1: Any statin approved by the regulatory authority in the respective country is allowed, with the exception of pravastatin, lovastatin, and fluvastatin
Note 2: If LDL-C is greater than 10 mg/dL (0.259 mmol/L) above target, patients are only eligible for the study if they are on the maximum allowable statin dose as per approved SPC in the respective country or on the maximum dose tolerated by the respective patient.
5. Fasting TG value at screening is>=175 mg/dL (1.97 mmol/L) and<=500 mg/dL (5.65 mmol/L) Note: If the patient fails to meet this criterion at Screening Visit (SV) 1, a fasting re-test of TG will be allowed at a second SV
6. HDL-C value at screening is<=50 mg/dL (1.30 mmol/L) for men and<=55 mg/dL (1.43 mmol/L)for women
7. Women may be enrolled if all 3 of the following criteria are met:
? They are not pregnant
? They are not breastfeeding and
? They do not plan on becoming pregnant during the study
8. Women of childbearing potential must have a negative urine pregnancy test at screening. Women are not considered to be of childbearing potential if they meet 1 of the following criteria as documented by the investigator:
? - They have had a hysterectomy or tubal ligation at minimum 1 cycle prior to signing the Informed Consent Form
? - They are post-menopausal, defined as >=1 year since their last menstrual period for women >= 55 years of age or >=1 year since their last menstrual period and have a follicle-stimulating hormone (FSH) level in menopausal range (defined as > 40 miU/mL) for women < 55 years of age
9. Women of childbearing potential must agree to use an effective method of contraception from screening to the end of the study. Effective methods of contraception are those contraceptive methods with a Pearl index of <1 used consistently and correctly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives or intrauterine devices)
10. Male study participants will be required to use condoms with a spermicide during sexual intercourse from screening to the end of the study, even if their sexual partner is or may be pregnant
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 373
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 373
","Exclusion criteria:
Patients will be excluded from participation in the study if any of the following criteria apply:
1. Patients who require other lipid lowering treatments in addition to study drug (K-877) and statin
2. Patients with body mass index =40 kg/m2
3. Patients with homozygous familial hypercholesterolaemia (heterozygous is permitted) or familial hypoalphalipoproteinaemia
4. Patients with type 1 diabetes mellitus
5. Patients with poorly controlled type 2 diabetes mellitus (haemoglobin A1c >10%)
6. Patients who are receiving insulin or insulin analogue treatment except for stable basal insulin therapy with a single insulin
7. Patients with moderate or severe renal impairment (ie, estimated glomerular filtration rate <50 mL/min/1.73m2) at screening
8. Patients with serious liver dysfunction; liver function test values >3 × upper limit of normal (ULN) of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at screening
9. Patients with a creatine kinase level >3 × ULN at screening
10. Patients with hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormalities), gall bladder disease or pancreatitis
11. Patients with a history of drug or alcohol abuse; allowed amounts of alcohol are an average of 20 g for women and 30 g for men per day as consumed in the course of a week
12. Patients who have a hypersensitivity/intolerance to peroxisome proliferator-activated receptor a agonists or statins, or for whom statins are contraindicated as per approved statin SPC
13. Patients who had myocardial infarction, artery angioplasty, bypass graft surgery or severe/unstable angina pectoris within 3 months prior to screening
14. Patients who had symptomatic cerebrovascular disease including cerebrovascular haemorrhage, ischaemia (including transient ischaemic attack), or carotid endarterectomy within 3 months of screening
15. Patients with symptomatic heart failure (New York Heart Association class III or IV)
16. Patients who have uncontrolled hypertension (seated systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg); Note: An average of 3 readings within an adequate time interval during the study visit may be used to determine blood pressure level
17. Patients who have used lipid modifying treatment other than statins within the 28 days prior to screening
18. Patients with a history of chronic active hepatitis B or hepatitis C or known to be infected with human immunodeficiency virus (HIV) 1 or HIV 2
19. Patients with known muscular or neuromuscular disease
20. Patients with known active or history (<10 years from previous event) of neoplastic disease (excluding basal cell cancer) or patients who may need to take antineoplastic treatment during the study period
21. Patients with uncontrolled hypothyroidism or hyperthyroidism
Note: controlled thyroid disease (normal serum thyroid stimulating hormone [TSH] and stable therapy for at least 3 months) is permitted
22. Patients who have participated in any other clinical studies within 3 months of screening
23. Patients who have experienced a loss of more than 400 mL of blood during the 3 months prior to screening, eg, as a blood donor
24. Patients with a clinically relevant abnormal history, physical examination findings, 12 lead ECG, or laboratory values at screening that in the opinion of the investigator could interfere with the objectives of the study or the safety of the patient
25. Patients with a high p","Main Objective: To assess the dose response of the following parameters:
•% change in non high density lipoprotein cholesterol (non HDL C) from baseline to Week 12
•% change in TG from baseline to Week 12
To assess the safety and tolerability of K 877 in patients with residual cardiovascular risk despite statin controlled LDL C concentration as particularly evaluated by:
•Change and % change in serum creatinine from baseline to Week 12
•Change and % change in homocysteine from baseline to Week 12
;Secondary Objective: To assess the response of the following parameters:
•% change in HDL-C, total cholesterol (TC), and apolipoprotein (Apo) B from baseline to Wk 12
•% change in Apo A1 and Apo A2 from baseline to Week 12
•% change in LDL-C, small LDL particles (small and dense LDL), very low density lipoprotein (VLDL-C) (calculated as TC - LDL-C - HDL-C), Apo B48, Apo B100, Apo C2, Apo C3, adiponectin, fibroblast growth factor 21 (FGF21), high sensitivity C reactive protein (hsCRP), lecithin cholesterol acyltransferase (LCAT), cholesteryl ester transfer protein (CETP) mass and activity, proprotein convertase subtilisin/kexin type 9 (PCSK9) mass, HDL function (reverse cholesterol transport, HDL driven endothelial production of nitric oxide, Ion mobility analysis, HDL sub fractions (including pre beta HDL) and lipid and lipoprotein ratios TC/HDL C, non HDL C/HDL C, Apo B/Apo A1, LDL C/Apo B, and Apo C3/Apo C2, from baseline to Wk 12
To measure PK parameters in a subset of patients per dose group;Primary end point(s): The primary efficacy endpoints of the study include the following:
• % change in non HDL C from baseline to Week 12
• % change in TG from baseline to Week 12
For the primary endpoints, non HDL C and TG, the primary analysis will be carried out using an analysis of covariance (ANCOVA) model with percent change from baseline to Week 12, baseline non HDL C, and baseline TG values as covariates, respectively. The superiority of K 877 groups compared to placebo will be assessed by Dunnett’s test, which will be performed separately for once daily (QD) and twice daily (BID) groups. As a secondary analysis, the dose response relationship in K 877 QD group and BID group will be separately assessed with a contrast method with the ANCOVA model. In addition, the difference between all groups will be assessed with the ANCOVA model. The primary efficacy analysis will be performed on the ITT and Per Protocol Populations.
The primary efficacy analysis will use the MMRM model for missing data imputation. Sensitivity analysis with LOCF method will be performed. Other possible solutions for the missing data imputation will also be explored, such as repeated measurements at Week 4, Week 8, and Week 12 with compound symmetry covariance structure and repeated measurements at Week 8 and Week 12 with compound symmetry covariance structure.
;Timepoint(s) of evaluation of this end point: 12 weeks","Timepoint(s) of evaluation of this end point: 12 weeks;Secondary end point(s): The secondary efficacy endpoints include the following:
• % change in HDL C, TC, and Apo B from baseline to Week 12
• % change in Apo A1 and Apo A2 from baseline to Week 12
• % change in LDL C, small LDL particles (small and dense LDL), VLDL C (calculated as TC - LDL-C - HDL-C), Apo B48, Apo C2, Apo C3, adiponectin, FGF21, hsCRP, LCAT, CETP mass and activity, PCSK9 mass, HDL function (reverse cholesterol transport, HDL driven endothelial production of nitric oxide, Ion mobility analysis, 2 D gel analysis for HDL sub fractions including pre beta HDL, Calculation: TC/HDL C, non HDL C/HDL C, Apo B/Apo A1, LDL C/Apo B, Apo B100, and Apo C3/C2 from baseline to Week 12
The secondary efficacy endpoints will be analysed using the same statistical method used for the primary analysis; however, Dunnett’s test will not be used to evaluate the superiority of the K 877 groups to the placebo group.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2014-01-13,NA,2013-07-26,350,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2014,NA,FALSE,FALSE,TRUE
26560,NA,NA,ISRCTN09576376,NCT: NA ICTRP: 2013-04-30 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,5,NA,only collected over 6 instead of 24 months,4,NA,no time frame,NCT: NA ICTRP: 46000 DRKS: NA,NA,1,0,NA,NA,NA,NA,NA,NA,0,no intervention,Studienprotokoll,https://doi.org/10.1186/1748-5908-9-27,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,N/A,Dental care REsistance prevention and Antibiotic prescribing Modification ? the DREAM trial,Dental care REsistance prevention and Antibiotic prescribing Modification ? A cluster-randomised controlled trial in German dental primary care ,christin.loeffler@med.uni-rostock.de,,Interventional,Two-arm single-centered cluster-randomized controlled trial (Prevention),Not Applicable,2013-04-30,2012-09-01,46000,Completed,Medical University of Rostock (Universitätsmedizin Rostock) (Germany),NULL,germany,"
The intervention involves elements of local consensus formation, antibiotic prescription feedback, and communication training. Training of the intervention group will be organized within small group sessions.
Control: Care as usual
","Inclusion criteria:
1. Primary care dentists and their male and female patient population of all ages in Mecklenburg-Western Pomerania (Germany).
2. Patients aged 18 years or older seen by their dentists for an odontogenic infection or abscess, and who have not been treated for such a condition in the previous six months, are eligible for being recruited into the subgroup (swabs).
",Exclusion criteria:
To investigate antibiotic prescribing the DREAM trial includes the entire patient population of participating dental practices.
Exclusion criteria for patients in the subgroup include:
1. Younger than 18 years
2. Not being able to give informed consent (e.g. in case of dementia)
3. Consulting the dentist during the emergency service
4. Suffering from immunosuppression or malignoma
5. Having a disease-related life expectancy of less than 12 months
,"Dentists? overall antibiotic prescription rate. Data is collected over a six-month baseline period (T0), at T1 (month 10 to 15), and T2 (month 19 to 24)",
Secondary outcomes for the subgroup:
1. Severity of illness
2. Pain (VAS)
3. Duration of treatment
4. Re-consultation rate
5. Use of medical services
6. Adverse effects related to antibiotic treatment
,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-09-01,NA,2013-04-30,46000,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,TRUE,NA,TRUE,2012,NA,FALSE,FALSE,FALSE
30523,NA,NA,EUCTR2006-001433-17,NCT: NA ICTRP: 2006-05-15 DRKS: NA,0,NA,Parallel and double blind according to title but registered as non-parallel and open,2,NA,NA,NA,2,NA,NA,5,NA,NA,NA,NA,NA,NCT: NA ICTRP: 120 DRKS: NA,NA,1,0,NA,NA,"contradictory information, see Des-Q",NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2006-11-01,NA,2007-05-31,2013-09-30,Interventional,HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab,"A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy",Completed,Phase 2,116,Actual,GlaxoSmithKline,Number of Participants With Objective Response (OR);Number of Participants Classified as Responders and Non-responders for Objective Response (OR),"Duration of Response;Progression-Free Survival;Time to Next Follicular Lymphoma (FL) Therapy;Overall Survival;Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24;Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12;Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood;Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24);Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14;Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2;Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.);Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7);AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7);t1/2 After the Eighth Infusion (Visit 9, Week 7);CL After the Eighth Infusion (Visit 9, Week 7);Vss After the Eighth Infusion (Visit 9, Week 7)",Hx-CD20-405;111772;111772,HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab,"A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy",;;;,;;;,Interventional,,Phase 2,2006-10-31,2007-05-20,116,Completed,GlaxoSmithKline,NULL,united kingdom;czech republic;denmark;france;germany;italy;netherlands;poland;spain;sweden;united states;united kingdom;czech republic;denmark;france;germany;italy;netherlands;poland;spain;sweden;united states;united kingdom;czech republic;denmark;france;germany;italy;netherlands;poland;spain;sweden;united states;united kingdom;czech republic;denmark;france;germany;italy;netherlands;poland;spain;sweden;united states,Drug: Ofatumumab;Drug: Ofatumumab;Drug: Ofatumumab;Drug: Ofatumumab;Drug: Ofatumumab;Drug: Ofatumumab;Drug: Ofatumumab;Drug: Ofatumumab,"
Inclusion Criteria
- Patient with follicular lymphoma grade 1 - 2
- Refractory to rituximab given as monotherapy or in combination with any chemotherapy
or to rituximab given as maintenance treatment following R-chemo, defined as:
- failure to achieve at least PR to rituximab given as monotherapy or in combination
with any chemotherapy; or,
- disease progression while on rituximab (either given as monotherapy or in combination
with any chemotherapy or during rituximab maintenance treatment following R-chemo);
or,
- disease progression in responders within 6 months of the last dose of rituximab
(either given as monotherapy or in combination with any chemotherapy or after
rituximab maintenance treatment schedule following R-chemo)
- Tumor verified to be CD20+ positive from excisional lymph node biopsy
- CT scan in screening phase (based on local evaluation) showing:
- 2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or
- 1 clearly demarcated lesion with a largest diameter = 2,0 cm
- ECOG Performance Status of 0, 1, or 2
- Age = 18 years
- Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out
Exclusion Criteria
- Previous autologous stem cell transplantation within 6 months
- Previous allogeneic stem cell transplantation
- More than 1 previous radio immunotherapy regimen
- Received radio immunotherapy within 3 months
- Received any Anti-cancer treatment within 4 weeks
- Received monoclonal antibodies, other than rituximab within 3 months
- Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
- Life expectancy less than 6 months
;
Inclusion Criteria
- Patient with follicular lymphoma grade 1 - 2
- Refractory to rituximab given as monotherapy or in combination with any chemotherapy
or to rituximab given as maintenance treatment following R-chemo, defined as:
- failure to achieve at least PR to rituximab given as monotherapy or in combination
with any chemotherapy; or,
- disease progression while on rituximab (either given as monotherapy or in combination
with any chemotherapy or during rituximab maintenance treatment following R-chemo);
or,
- disease progression in responders within 6 months of the last dose of rituximab
(either given as monotherapy or in combination with any chemotherapy or after
rituximab maintenance treatment schedule following R-chemo)
- Tumor verified to be CD20+ positive from excisional lymph node biopsy
- CT scan in screening phase (based on local evaluation) showing:
- 2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or
- 1 clearly demarcated lesion with a largest diameter = 2,0 cm
- ECOG Performance Status of 0, 1, or 2
- Age = 18 years
- Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out
Exclusion Criteria
- Previous autologous stem cell transplantation within 6 months
- Previous allogeneic stem cell transplantation
- More than 1 previous radio immunotherapy regimen
- Received radio immunotherapy within 3 months
- Received any Anti-cancer treatment within 4 weeks
- Received monoclonal antibodies, other than rituximab within 3 months
- Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
- Life expectancy less than 6 months
;
Inclusion Criteria
- Patient with follicular lymphoma grade 1 - 2
- Refractory to rituximab given as monotherapy or in combination with any chemotherapy
or to rituximab given as maintenance treatment following R-chemo, defined as:
- failure to achieve at least PR to rituximab given as monotherapy or in combination
with any chemotherapy; or,
- disease progression while on rituximab (either given as monotherapy or in combination
with any chemotherapy or during rituximab maintenance treatment following R-chemo);
or,
- disease progression in responders within 6 months of the last dose of rituximab
(either given as monotherapy or in combination with any chemotherapy or after
rituximab maintenance treatment schedule following R-chemo)
- Tumor verified to be CD20+ positive from excisional lymph node biopsy
- CT scan in screening phase (based on local evaluation) showing:
- 2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or
- 1 clearly demarcated lesion with a largest diameter = 2,0 cm
- ECOG Performance Status of 0, 1, or 2
- Age = 18 years
- Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out
Exclusion Criteria
- Previous autologous stem cell transplantation within 6 months
- Previous allogeneic stem cell transplantation
- More than 1 previous radio immunotherapy regimen
- Received radio immunotherapy within 3 months
- Received any Anti-cancer treatment within 4 weeks
- Received monoclonal antibodies, other than rituximab within 3 months
- Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
- Life expectancy less than 6 months
;
Inclusion Criteria
- Patient with follicular lymphoma grade 1 - 2
- Refractory to rituximab given as monotherapy or in combination with any chemotherapy
or to rituximab given as maintenance treatment following R-chemo, defined as:
- failure to achieve at least PR to rituximab given as monotherapy or in combination
with any chemotherapy; or,
- disease progression while on rituximab (either given as monotherapy or in combination
with any chemotherapy or during rituximab maintenance treatment following R-chemo);
or,
- disease progression in responders within 6 months of the last dose of rituximab
(either given as monotherapy or in combination with any chemotherapy or after
rituximab maintenance treatment schedule following R-chemo)
- Tumor verified to be CD20+ positive from excisional lymph node biopsy
- CT scan in screening phase (based on local evaluation) showing:
- 2 or more clearly demarcated lesions with a largest diameter = 1.5 cm, or
- 1 clearly demarcated lesion with a largest diameter = 2,0 cm
- ECOG Performance Status of 0, 1, or 2
- Age = 18 years
- Following receipt of verbal and written information about the study, the patient must
provide signed informed consent before any study related activity is carried out
Exclusion Criteria
- Previous autologous stem cell transplantation within 6 months
- Previous allogeneic stem cell transplantation
- More than 1 previous radio immunotherapy regimen
- Received radio immunotherapy within 3 months
- Received any Anti-cancer treatment within 4 weeks
- Received monoclonal antibodies, other than rituximab within 3 months
- Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
- Life expectancy less than 6 months
",NULL,Number of Participants With Objective Response (OR);Number of Participants Classified as Responders and Non-responders for Objective Response (OR);Number of Participants With Objective Response (OR);Number of Participants Classified as Responders and Non-responders for Objective Response (OR),"Duration of Response;Progression-Free Survival;Time to Next Follicular Lymphoma (FL) Therapy;Overall Survival;Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24;Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12;Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood;Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24);Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14;Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2;Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.);Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7);AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7);t1/2 After the Eighth Infusion (Visit 9, Week 7);CL After the Eighth Infusion (Visit 9, Week 7);Vss After the Eighth Infusion (Visit 9, Week 7)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-05-31,2006-10-31,2006-10-31,116,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,NA,TRUE,FALSE,TRUE
30886,NA,NA,EUCTR2006-005357-29,NCT: NA ICTRP: 2007-08-16 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no time frame",1,NA,info on secondary endpoints only in objectives section,NCT: NA ICTRP: 369 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,WA20500;2006-005357-29-GB,"A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG","A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG ",,,Interventional,"Controlled: yesRandomised: yesOpen: noSingle blind: noDouble blind: yesParallel group: yesCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: noPlacebo: yesOther: no",NULL,2007-10-01,2008-01-31,369,Not Recruiting,F. Hoffmann-La Roche Ltd,NULL,portugal;hungary;united kingdom;germany;netherlands;bulgaria;france;spain;sweden,
Product Name: ocrelizumab
Product Code: RO 496-4913
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ocrelizumab
Current Sponsor code: RO 496-4913
Other descriptive name: RhuMAb 2H7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use
,"Inclusion criteria:
Patients must meet the following criteria to be eligible for study entry. Documentation of each specific criterion must be present in the patient’s chart notes:
1. Age 16 years or above at the time of the screening, unless the inclusion of minors is prohibited by the local regulations.
2. Ability and willingness to provide written informed consent (or to obtain consent from a parent guardian where applicable) and to comply with the schedule of protocol requirements.
3. Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening.
4. Active lupus nephritis defined as follows: Biopsy proven (within 6 months prior to randomization) WHO or ISN Class III or IV LN (excluding III (C), IV-S (C) and IV-G (C),
Patients are permitted to have co-existing Class V (see Table 1). Whenever possible, biopsies should be graded and reported following ISN/RPS classification scheme. AND The presence of: Urinary protein to Urinary creatinine ratio = 1. The proteinuria must not have improved by = 50% in the preceding 6 months. The urine sample used to define this ratio is the 24 hour screening sample which is measured by the central laboratory. If collection and analysis of a 24 hour urine sample is not possible prior to randomization then a timed urine collection (at least 12 hours) should be obtained.
Determination of eligibility based on a first-void morning 'spot' urine sample is acceptable if collection and analysis of a timed urine sample is not possible prior to randomization.
5. For patients of reproductive potential (males and females), a reliable means of contraception must be used for the duration of the study (e.g. hormonal contraceptive, intrauterine device, physical barrier) according to local guidelines and the treating physician’s recommendations. The relevant section of the product label for CYC, MMF or AZA (as appropriate) should be followed.
6. Female patients of childbearing potential must have a negative serum pregnancy test from the screening visit prior to enrollment at Day 1.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
1. Currently active retinitis, poorly controlled seizure disorder,
acute confusional state, myelitis, stroke or stroke syndrome,
cerebellar ataxia or dementia.
2. Severe renal impairment as defined by calculated (Cockcroft-Gault) GFR < 25 mL/min, or the presence of oliguria or renal biopsy results indicating chronic
irreversible renal scarring.
3. Lack of peripheral venous access.
4. Pregnancy or breast feeding mothers.
5. History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin.
6. Known severe chronic pulmonary disease.
7. Evidence of significant uncontrolled concomitant diseases in
any organ system not related to SLE (e.g. renal thrombosis,
atherosclerotic cardiovascular disease, diabetes mellitus,
accelerated hypertension, poorly controlled COPD or asthma
etc), which, in the investigator’s opinion, would preclude
patient participation.
8. Concomitant condition (e.g. asthma, Crohn’s disease, etc)
which has required treatment with systemic corticosteroid
(excluding topical or inhaled steroids) at any time in the
52 weeks prior to screening.
9. Known HIV or chronic active Hepatitis B or chronic active
Hepatitis C infection.
10. Known active, clinically significant infection of any kind (with the exception of fungal infection of nail beds or oral thrush) or any major
episode of infection requiring hospitalization or treatment
with intravenous anti-infectives in the 14 days prior to Day 1. Patients may be enrolled in the presence of recent minor infections not requiring treatment with anti-infectives (e.g. viral upper respiratory tract infection, viral gastroenteritis), if in the investigator´s opinion, the infection has resolved prior to Day 1 and is unlikely to persent additional risk to the subject.
11. History of serious recurrent or chronic infection. A chest
radiograph will be performed during screening, if not
performed in the 12 weeks prior to screening, to assess
infection. If there is any evidence of pulmonary infection a
chest radiograph should be performed.
12. History of cancer, including solid tumors, hematological
malignancies and carcinoma in situ (except basal cell
carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured).
13. History of alcohol or drug abuse in the 52 weeks prior to
screening.
14. Major surgery in the 4 weeks prior to screening, excluding
diagnostic surgery.
15. Previous treatment with CAMPATH-1H.
16. Previous treatment with a BAFF directed treatment
(e.g. anti-BLyS) in the 12 months prior to screening.
17. Previous treatment with a B-cell targeted therapy (e.g. anti-CD20, anti-CD22) other than one directed at BAFF.
18. Treatment with any investigational agent in the 28 days prior
to screening or within five half-lives of the investigational
drug (whichever is longer).
19. Receipt of any live vaccines in the 6 weeks prior to Day 1.
20. Intolerance or contraindication to oral or i.v. corticosteroids.
21. Treatment with more than 1 g CYC (cumulative dose) in the
6 months prior to screening period.
22. Receipt of more than 3 g i.v. pulse methylprednisolone (cumulative
dose) within the 12 weeks prior to screening.
23. Receipt of prednisone doses > 20 mg/day ( or equivalent including parenteral corticosteroids, except for pulse steroids as defined in exclusion criteria #22) for longer than 14 days within a 12 weeks period prior to screening. During the 14 days prior to scr","Main Objective: To investigate the ability of the ocrelizumab regimen in
combination with standard of care treatment (SOC) to induce a
complete or partial renal response, as assessed by renal function,
urinary sediment and proteinuria in patients with ISN/RPS or
WHO class III or IV lupus nephritis.;Secondary Objective: • To assess the safety and tolerability of ocrelizumab.
• To evaluate the PK, immunogenicity and PD parameters of ocrelizumab in this patient population.
• To evaluate corticosteroid sparing in patients receiving ocrelizumab.
• To evaluate the effect of ocrelizumab on extra-renal disease manifestations
• To evaluate the impact of ocrelizumab on symptoms and patient functioning using the SF-36, Facit Fatigue and modified Brief Pain Inventory (mBPI-SF).;Primary end point(s): The comparison of the two experimental arms (ocrelizumab 400 mg versus ocrelizumab 1000 mg) will be explored within this study).
",NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-01-31,NA,2007-10-01,369,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2008,NA,FALSE,FALSE,TRUE
32817,NA,NA,EUCTR2010-022939-11,NCT: NA ICTRP: 2011-02-09 DRKS: NA,0,NA,no info,1,NA,NA,NA,2,NA,NA,4,NA,no time frame,1,NA,"no AM, no time frame, no measure, no metric",NCT: NA ICTRP: 115 DRKS: NA,NA,1,0,NA,NA,no info,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2010-11-08,NA,2011-02-28,2014-01-31,Interventional,Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL),"Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma",Completed,Phase 2,115,Actual,Pharmacyclics LLC.,Percentage of Participants Achieving Response,Number of Participants With Treatment Emergent Adverse Events (AEs);PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765;Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score,PCI-32765;PCYC-1104-CA,Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL),"Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma",;;;,;;;,Interventional,,Phase 2,2010-10-18,2011-02-20,115,Completed,Pharmacyclics LLC.,Janssen Pharmaceuticals,united states;germany;poland;united kingdom;germany;poland;united kingdom;united states;austria;united states;germany;poland;united kingdom;germany;poland;united kingdom;united states;austria;united states;germany;poland;united kingdom;germany;poland;united kingdom;united states;austria;united states;germany;poland;united kingdom;germany;poland;united kingdom;united states;austria,Drug: PCI-32765;Drug: PCI-32765;Drug: PCI-32765;Drug: PCI-32765,"
Inclusion Criteria:
- Men and women = 18 years of age
- ECOG performance status of = 2
- Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1
or t(11;14), and measurable disease on cross sectional imaging that is = 2 cm in the
longest diameter and measurable in 2 perpendicular dimensions
- Documented failure to achieve at least partial response (PR) with, or documented
disease progression disease after, the most recent treatment regimen
- At least 1, but no more than 5, prior treatment regimens for MCL (Note: Subjects
having received =2 cycles of prior treatment with bortezomib, either as a single agent
or as part of a combination therapy regimen, will be considered to be
bortezomib-exposed.)
- Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty
- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (in accordance
with national and local subject privacy regulations)
Major exclusion criteria:
- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer
antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation
therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
- Any life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue
risk
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart
Association Functional Classification
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel or ulcerative colitis, symptomatic
inflammatory bowel disease, or partial or complete bowel obstruction
- Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is
documented bone marrow involvement
2. Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion support
unless there is documented bone marrow involvement
3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) = 3.0
x upper limit of normal (ULN)
4. Creatinine > 2.0 x ULN
;
Inclusion Criteria:
- Men and women = 18 years of age
- ECOG performance status of = 2
- Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1
or t(11;14), and measurable disease on cross sectional imaging that is = 2 cm in the
longest diameter and measurable in 2 perpendicular dimensions
- Documented failure to achieve at least partial response (PR) with, or documented
disease progression disease after, the most recent treatment regimen
- At least 1, but no more than 5, prior treatment regimens for MCL (Note: Subjects
having received =2 cycles of prior treatment with bortezomib, either as a single agent
or as part of a combination therapy regimen, will be considered to be
bortezomib-exposed.)
- Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty
- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (in accordance
with national and local subject privacy regulations)
Major exclusion criteria:
- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer
antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation
therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
- Any life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue
risk
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart
Association Functional Classification
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel or ulcerative colitis, symptomatic
inflammatory bowel disease, or partial or complete bowel obstruction
- Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is
documented bone marrow involvement
2. Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion support
unless there is documented bone marrow involvement
3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) = 3.0
x upper limit of normal (ULN)
4. Creatinine > 2.0 x ULN
;
Inclusion Criteria:
- Men and women = 18 years of age
- ECOG performance status of = 2
- Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1
or t(11;14), and measurable disease on cross sectional imaging that is = 2 cm in the
longest diameter and measurable in 2 perpendicular dimensions
- Documented failure to achieve at least partial response (PR) with, or documented
disease progression disease after, the most recent treatment regimen
- At least 1, but no more than 5, prior treatment regimens for MCL (Note: Subjects
having received =2 cycles of prior treatment with bortezomib, either as a single agent
or as part of a combination therapy regimen, will be considered to be
bortezomib-exposed.)
- Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty
- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (in accordance
with national and local subject privacy regulations)
Major exclusion criteria:
- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer
antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation
therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
- Any life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue
risk
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart
Association Functional Classification
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel or ulcerative colitis, symptomatic
inflammatory bowel disease, or partial or complete bowel obstruction
- Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is
documented bone marrow involvement
2. Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion support
unless there is documented bone marrow involvement
3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) = 3.0
x upper limit of normal (ULN)
4. Creatinine > 2.0 x ULN
;
Inclusion Criteria:
- Men and women = 18 years of age
- ECOG performance status of = 2
- Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1
or t(11;14), and measurable disease on cross sectional imaging that is = 2 cm in the
longest diameter and measurable in 2 perpendicular dimensions
- Documented failure to achieve at least partial response (PR) with, or documented
disease progression disease after, the most recent treatment regimen
- At least 1, but no more than 5, prior treatment regimens for MCL (Note: Subjects
having received =2 cycles of prior treatment with bortezomib, either as a single agent
or as part of a combination therapy regimen, will be considered to be
bortezomib-exposed.)
- Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules without difficulty
- Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information (in accordance
with national and local subject privacy regulations)
Major exclusion criteria:
- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic anticancer
antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation
therapy within 3 weeks, or major surgery within 2 weeks of first dose of study drug
- Any life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue
risk
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart
Association Functional Classification
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel or ulcerative colitis, symptomatic
inflammatory bowel disease, or partial or complete bowel obstruction
- Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is
documented bone marrow involvement
2. Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion support
unless there is documented bone marrow involvement
3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) = 3.0
x upper limit of normal (ULN)
4. Creatinine > 2.0 x ULN
",NULL,Percentage of Participants Achieving Response;Percentage of Participants Achieving Response,Number of Participants With Treatment Emergent Adverse Events (AEs);PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765;Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-02-28,2010-10-18,2010-10-18,115,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2011,NA,TRUE,FALSE,TRUE
30453,NA,NA,EUCTR2006-000870-63,NCT: NA ICTRP: 2007-01-11 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,0,NA,secondary endpoints are mentioned in the secondary objectives but no details given,NCT: NA ICTRP: 524 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2007-02-16,NA,2007-03-31,2010-12-31,Interventional,A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).,"A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.",Completed,Phase 4,551,Actual,Hoffmann-La Roche,Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment,"Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72;Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment;Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment;Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment;Percentage of Participants With Normal Alanine Aminotransferase (ALT);Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment;Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment;Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment;Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment;Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment;Quantitative HBV-DNA 24 Weeks Following End of Treatment",WV19432,A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).,"A Randomized, Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B.",;;;,;;;,Interventional,,Phase 4,2007-02-15,2007-03-20,551,Completed,Hoffmann-La Roche,NULL,"united states;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;united states;united states;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;united states;united states;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;united states;united states;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;australia;brazil;china;france;germany;hong kong;korea, republic of;new zealand;russian federation;singapore;taiwan;thailand;united states",Drug: peginterferon alfa-2a [Pegasys];Drug: peginterferon alfa-2a [Pegasys];Drug: peginterferon alfa-2a [Pegasys];Drug: peginterferon alfa-2a [Pegasys],"
Inclusion Criteria:
- adult patients, >=18 years of age;
- positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA
>500,000 copies/mL, and anti-HBs negative;
- liver disease consistent with Chronic Hepatitis B.
Exclusion Criteria:
- antiviral therapy for CHB within previous 6 months;
- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus
(HDV) or Human immuno deficiency virus (HIV);
- evidence of decompensated liver disease;
- medical condition associated with chronic liver disease.
;
Inclusion Criteria:
- adult patients, >=18 years of age;
- positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA
>500,000 copies/mL, and anti-HBs negative;
- liver disease consistent with Chronic Hepatitis B.
Exclusion Criteria:
- antiviral therapy for CHB within previous 6 months;
- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus
(HDV) or Human immuno deficiency virus (HIV);
- evidence of decompensated liver disease;
- medical condition associated with chronic liver disease.
;
Inclusion Criteria:
- adult patients, >=18 years of age;
- positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA
>500,000 copies/mL, and anti-HBs negative;
- liver disease consistent with Chronic Hepatitis B.
Exclusion Criteria:
- antiviral therapy for CHB within previous 6 months;
- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus
(HDV) or Human immuno deficiency virus (HIV);
- evidence of decompensated liver disease;
- medical condition associated with chronic liver disease.
;
Inclusion Criteria:
- adult patients, >=18 years of age;
- positive Hepatitis B surface antigen (HBsAg) for >6 months, positive HBeAg, HBV DNA
>500,000 copies/mL, and anti-HBs negative;
- liver disease consistent with Chronic Hepatitis B.
Exclusion Criteria:
- antiviral therapy for CHB within previous 6 months;
- co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus
(HDV) or Human immuno deficiency virus (HIV);
- evidence of decompensated liver disease;
- medical condition associated with chronic liver disease.
",NULL,Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment;Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment,"Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72;Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment;Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment;Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment;Percentage of Participants With Normal Alanine Aminotransferase (ALT);Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment;Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment;Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment;Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment;Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment;Quantitative HBV-DNA 24 Weeks Following End of Treatment",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-03-31,2007-02-15,2007-02-15,551,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,NA,TRUE,FALSE,TRUE
31804,NA,NA,EUCTR2008-004422-16,NCT: NA ICTRP: 2008-12-17 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,1,NA,NA,NA,NA,NA,NCT: NA ICTRP: 96 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,EA08-3-998,Investigation of local tolerability and efficacy of Muxan - a new topical treatment containing chloramine-T in 3 concentrations in comparison to Zovirax® in patients with Herpes simplex type 1 - Local tolerability and efficacy of Muxan (chloramine-T containing ointment),Investigation of local tolerability and efficacy of Muxan - a new topical treatment containing chloramine-T in 3 concentrations in comparison to Zovirax® in patients with Herpes simplex type 1 - Local tolerability and efficacy of Muxan (chloramine-T containing ointment) ,,,Interventional,"Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: monocentre, four-arms, multiple treatment
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
",Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no,2008-12-17,2009-01-28,96,Not Recruiting,Engelhard Arzneimittel GmbH & Co. KG,NULL,germany,"
Product Name: Muxan 0,5%
Pharmaceutical Form: Ointment
INN or Proposed INN: Tosylchloramide sodium
CAS Number: 127-65-1
Other descriptive name: Chloramine-T
Concentration unit: % (W/W) percent weight/weight
Concentration number: 0,5-
Product Name: Muxan 1%
Pharmaceutical Form: Ointment
INN or Proposed INN: Tosylchloramide sodium
CAS Number: 127-65-1
Other descriptive name: Chloramine-T
Concentration unit: % (W/W) percent weight/weight
Concentration number: 1-
Product Name: Muxan 2%
Pharmaceutical Form: Ointment
INN or Proposed INN: Tosylchloramide sodium
CAS Number: 127-65-1
Other descriptive name: Chloramine-T
Concentration unit: % (W/W) percent weight/weight
Concentration number: 2-
Trade Name: Zovirax® Lippenherpescreme
Pharmaceutical Form: Cream
INN or Proposed INN: Aciclovir
CAS Number: 59277-89-3
Other descriptive name: Acycloguanosine
Concentration unit: % (W/W) percent weight/weight
Concentration number: 5-
","Inclusion criteria:
· Male or female patients with at least 18 years of age
· Recurrent HSV-1 episodes, at least 2 episodes of typical lesions in the last year
· Acute HSV-1 episode
· Healthy immune response
· History of at least 50% of herpes labialis episodes producing classical” lesion
· Female subject must be using a medically acceptable form of birth control during the study. Acceptable birth control measures are abstinence, oral contraceptive pills or patch, injectable contraception, barrier contraceptives (condom, diaphragm with spermicide), IUD, surgical (hysterectomy, tubal ligation), vasectomized partner, or natural post menopausal inability to conceive.
· Be able to communicate with the investigator and compliant
· The patient must give written informed consent, after having been informed about benefits and potential risks of the trial, as well details of the insurance taken out to cover the subjects participating in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
· Multiple simultaneous lesions
· Area of herpes labialis involves greater than 1,5 cm in diameter
· Lesions that had already formed a crust
· Cytotoxic, immunosuppressive or immunomodifying drugs within 3 month
· Use of an anti-viral medication in the preceding 30 days
· Any evidence of active malignancy, within 3 month prior to enrollment (subjects who have completed therapy and are considered unlikely to relapse or who have had surgery and do not have any evidence of disease, are eligible for the study)
· Female patients who are pregnant and/or nursing or planning a pregnancy
· Females of childbearing potential, with positive urine pregnancy test at time of screening
· Congenital, acquired or corticosteroid-induced immunodeficiency
· History of allergic or adverse response to acyclovir, or any related anti-viral drug, or the cream base
· History of intolerance or hypersensitivity to chloramine-T, or other ointment components
· Current significant skin disease within the affected area
· Use of topical medications in the affected area within 72 hours prior to study enrolment
· History of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV
· No participation in another clinical drug research study 1 month before inclusion, during the study and at least 1 month after the study end
· Allergy for any drug or idiosyncrasy (excludes a pollen allergy without current symptoms)
· Having exanthem, pigment abnormality, other skin symptoms such as wounds and/or an excessive sunburn in the affected area
· Abnormal skin conditions that occur in the area ordinarily affected by cold sores which might affect the normal course of cold sores (e.g. eczema, psoriasis, albinism, or chronic vesiculobullous disorders)
· History of clinically significant itching, erythema and/or rash by any locally applied treatment
· Unreliability or unability to understand or follow the protocol directions or to comprehend or satisfactorily use the measurement scales as determined by investigator or designee at screening
","Main Objective: · Assessment of local tolerability of three concentrations of chloramine-T-containing ointments (Muxan);Secondary Objective: · Assessment of global tolerability of three concentrations of chloramine-T-containing ointments (Muxan) by the patient
· Assessment of global tolerability of three concentrations of chloramine-T-containing ointments (Muxan) by the investigator
· Characterisation of safety and tolerability of the investigational products considering Adverse Events in the study population
· Assessment of the effectiveness of chloramine-T ointment compared to Zovirax® cream using a combined symptom score of values for complaints (every study day), at all visits of treatment (healing rate, descriptive evaluation)
· Assessment of prevention of progression to a classical lesion
· Time from treatment initiation to cessation of pain and other typical symptoms
· Occurrence of crusting
· Number of secondary infections
;Primary end point(s): Assessment of local tolerability (subjective symptoms, descriptive evaluation)",NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-01-28,NA,2008-12-17,96,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2009,NA,FALSE,FALSE,TRUE
28275,NA,NA,ISRCTN43578978,NCT: NA ICTRP: 2010-06-10 DRKS: NA,1,1,NA,1,1,NA,NA,2,1,NA,4,1,no AM,4,1,no AM,NCT: NA ICTRP: 400 DRKS: NA,304,1,0,NA,NA,NA,NA,NA,NA,0,no outcome,ganzer Artikel,https://doi.org/10.1016/j.jamda.2013.05.017,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,LT 44-076,Improving the treatment of neuropsychiatric symptoms in nursing home residents suffering from dementia,Evaluation of a combined guideline implementation protocol for neuropsychiatric symptoms in nursing home residents suffering from dementia ,michael.rapp@charite.de,,Interventional,Cluster randomised controlled trial (Treatment),NULL,2010-06-10,2008-11-01,400,Completed,Federal Office of Administration (Bundesverwaltungsamt [BVA]) (Germany),NULL,germany,"18 care centres in Berlin will be randomised to the intervention or control conditions:
1. Intervention centres:
1.1. 20 hours of training for nursing staff on causes, symptomatology and treatment of neuropsychiatric symptoms in dementia
1.2. 4 hours of training for primary care psychiatrists on causes and medical treatment of neuropsychiatric symptoms in dementia
1.3. 15 minute individual occupational therapy sessions twice a week
1.4. Provision of and training in standardized assessments of neuropsychiatric symptoms in dementia (nursing staff)
2. Control centres: treatment as usual
The total duration of the intervention and follow up will be 9 months",Inclusion criteria: Both male and female dementia patients aged 60 or older who live in a nursing home,"Exclusion criteria: 1. Inability to give informed consent and absence of a caregiver holding power of attorney
2. Any of the following conditions as defined by ICD-10 criteria
2.1. Presence of substance abuse (F 10)
2.2. Schizophrenia and associated conditions (F20)
2.3. Bipolar disorder (F30,31)",1. Agitation as measured with the Cohen-Mansfield Agitation inventory (CMAI)
2. Depression as measured with the Dementia Mood Assessment Scale (DMAS)
3. Apathy as measured with the Apathy Evaluation Scale (AES)
All primary outcomes are measured at baseline and at 12 months.,"1. Psychotropic medication in defined daily dosages
2. Number of hospital admissions
3. Caregiver burden as measured with the Perceived Stress Scale (PSS)
4. Mortality
All secondary outcomes are measured at baseline, months 3, 6, and 12, and mortality dates are ascertained retrospectively.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2008-11-01,NA,2010-06-10,400,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2008,NA,FALSE,FALSE,FALSE
29200,NA,NA,ISRCTN50665418,NCT: NA ICTRP: 2005-10-21 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,"no AM, no time frame",3,NA,"no AM, no measure",NCT: NA ICTRP: 41 DRKS: NA,NA,1,1,NA,NA,info from title,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,601/PO,"Randomised, double-blind, placebo-controlled, multi-centre, parallel group study to investigate the safety and tolerability as well as the immunological and clinical effects of multiple subcutaneous doses of DiaPep277 in latent autoimmune diabetes in adults (LADA) patients", ,,,Interventional,Randomised controlled trial (Treatment),NULL,2005-10-21,2001-04-17,41,Completed,DeveloGen AutoImmune GmbH (Germany),NULL,germany,"Treatment with subcutaneous injections of DiaPep277 or placebo in three different treatment groups with different schedules for a period of approximately 18-20 months. Follow up until 2 years after the first administration of study drug.
Group A: Administration of 1 mg DiaPep277 or placebo at the start of the study and 1 month, 6 months, 12 months and 18 months later. In total five administrations.
Group B: Administration of 1 mg DiaPep277 or placebo at the start of the study and 2 weeks, 4 weeks, 6 weeks and 8 weeks later. Further administrations in intervals of approximately 3 months. In total 10 administrations.
Group C: Administration of 0.2 mg DiaPep277 or placebo at the start of the study and 2 weeks, 4 weeks, 6 weeks and 8 weeks later. This course is repeated 6 months, 12 months and 18 months after the first administration. In total 20 administrations.","Inclusion criteria: 1. Patients with a diagnosis of diabetes mellitus according to World Health Organisation (WHO) classification for more than 2 months and less than 5 years before enrolment
2. Diabetes controlled by diet, oral antidiabetics or insulin therapy
3. Positive for glutamic acid decarboxylase (GAD) autoantibodies
4. Male caucasian patients, aged 30 to 50 years, or female caucasian patients, aged 30 to 50 years, who are not pregnant and use safe contraceptive methods","Exclusion criteria: 1. Patients with secondary diabetes mellitus
2. Any previous insulin treatment before the first injection of study drug
3. History of intolerance or contraindications to oral hypoglycaemic medications
4. Clinical evidence of any severe diabetes-related complication
5. Allergy to investigational drug
6. History of severe allergy or asthma
7. Known immune deficiency from any disease, or a condition associated with an immune deficiency
8. Use of immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication which, in the opinion of the investigator, might interfere with the study","Pancreatic beta-cell function, insulin independency or change in insulin dose, metabolic control: most parameters at every 6 months.","Immune response (every 6 months), clinical safety and tolerability at each visit.",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-04-17,NA,2005-10-21,41,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2001,NA,FALSE,FALSE,FALSE
31383,NA,NA,EUCTR2007-004574-11,NCT: NA ICTRP: 2007-12-07 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no measure (of progression),4,NA,no measure (of response),NCT: NA ICTRP: 120 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,0,no outcome,kein Artikel,NA,NA,2009-10-08,NA,2009-06-30,2011-12-31,Interventional,CS-1008 With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer (NSCLC),"Randomised, Double-Blinded, Placebo Controlled, Phase 2 Study of CS-1008 in Combination With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer",Completed,Phase 2,109,Actual,"Daiichi Sankyo, Inc.",Difference in progression-free survival (PFS) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin,Difference in overall survival of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin;Difference in objective response rate (ORR) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin;Difference in duration of response of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin,CS1008-A-E202,CS-1008 With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer (NSCLC),"Randomised, Double-Blinded, Placebo Controlled, Phase 2 Study of CS-1008 in Combination With Carboplatin/Paclitaxel in Chemotherapy naïve Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer",NULL,NULL,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment",Phase 2,2009-10-07,2009-06-20,109,Completed,Daiichi Sankyo Inc.,NULL,germany,Drug: CS-1008;Drug: Placebo;Drug: Paclitaxel;Drug: Carboplatin,"
Inclusion Criteria:
- At least 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Measurable disease as defined by RECIST criteria
- Adequate organ and bone marrow function as evidenced by:
- Hemoglobin >= 9 g/dL;
- ANC >= 1.5 x 109/L;
- Platelet count >= 100 x 109/L;
- Serum creatinine < 1.5 mg/dL or creatinine clearance > 60 mL/min;
- AST, ALT, and alkaline phosphatase <= 2.5 x upper limit of normal (ULN) if
without liver metastasis and <= 5.0 x ULN if liver metastasis;
- Total bilirubin <= 2.0 x ULN.
- Men and women of childbearing potential must be willing to consent to using effective
double barrier contraception (eg, hormonal contraceptives, bilateral tubal ligation,
barrier with spermicidal, intrauterine device) while on treatment and for 3 months
thereafter.
- All female subjects of childbearing potential must have a negative pregnancy test
(serum or urine) result <= 72 hours before initiating study treatment.
- Subjects must be fully informed about their illness and the investigational nature of
the study protocol (including foreseeable risks and possible side effects) and must
sign and date an IEC approved ICF before performance of any study specific procedures
or tests.
Exclusion Criteria:
- Anticipation of need for a major surgical procedure or radiotherapy (RT) during the
study.
- Prior treatment with chemotherapy for their disease.
- History of any of the following conditions within 6 months before study enrolment:
myocardial infarction; New York Heart Association (NYHA) class II or higher
severe/unstable angina pectoris; coronary/peripheral artery bypass graft; NYHA class
III or IV congestive heart failure; cerebrovascular accident or transient ischemic
attack, pulmonary embolism, or other clinically significant thromboembolic event;
clinically significant pulmonary disease (eg, severe chronic obstructive pulmonary
disease or asthma); clinically significant pulmonary edema or anasarca.. See Section
17.2 for NYHA Classification.
- Clinically significant pleural or pericardial effusions.
- Grade 2 or higher current peripheral neuropathy (See Section 17.3; NCI CTCAE, Version
3.0).
- Clinically active brain metastasis (ie, untreated, still requiring therapy with
steroids or RT, or with progression within 4 weeks after completion of RT); an
uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis.
- History of malignancy other than NSCLC, unless there is the expectation that the
malignancy has been cured, and tumor specific treatment for the malignancy has not
been administered within the previous 5 years.
- Clinically significant active infection that requires antibiotic therapy or Human
Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy.
- Previous treatment with chemotherapy, CS 1008, other agonistic DR 5 or DR 4
antibodies, or with TRAIL.
- Pregnant or breast feeding.
- Known history of hypersensitivity reactions to any of the components of CS 1008,
carboplatin, or paclitaxel formulations.
- Serious intercurrent medical or psychiatric illnesses or any other conditions that in
the opinion of the Investigator would impair the ability to give informed consent or
unacceptably reduce protocol compliance or safety of the study treatment.
",NULL,Difference in progression-free survival (PFS) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin,Difference in overall survival of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin;Difference in objective response rate (ORR) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin;Difference in duration of response of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-06-30,2009-10-07,2009-10-07,109,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2009,NA,TRUE,FALSE,TRUE
33014,NA,NA,EUCTR2011-001202-99,NCT: NA ICTRP: 2011-05-16 DRKS: NA,1,NA,NA,1,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 300 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,CNSB015CP01,"A study to investigate whether the administration of flupirtine in combination with opioids is safe, tolerable and efficacious when administered to cancer patients who are suffering from pain that shows neuropathic characteristics","A Phase IIb/III, Double-Blind, Placebo-Controlled, Randomized Study Investigating the Safety, Tolerability and Efficacy of Flupirtine as Adjunct to Opioids When Administered to Cancer Subjects Who Are Experiencing Pain With Neuropathic Features ",curtis.head@relevarepharma.com,curtis.head@relevarepharma.com,Interventional,"Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
",Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no,2011-05-16,2011-10-18,300,Not Recruiting,"Relevare Pharmaceuticals, Ltd.",NULL,germany,"
Trade Name: Katadolon 100mg, Hartkapsel
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FLUPIRTINE MALEATE
CAS Number: 75507-68-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
","Inclusion criteria:
1. Presence of a solid neoplasm and between the ages of 18 and 65 years, inclusive
2. Able to understand written and verbal communication in the primary language of the country in which the study is being undertaken
3. Life expectancy a minimum of 3 months with Karnofsky score =50 at the Screening Visit (Day -7)
4. History of daily pain attributable to cancer and requiring treatment with strong opioids for at least 3 months duration
5. Pain with neuropathic characteristics that include one or more of the following: throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, splitting, tiring-exhausting, sickening, fearful, punishing-cruel, electric-shock, cold-freezing, piercing, caused by light touch, itching, tingling or ‘pins and needles’, or numbness.
6. Pain inadequately relieved despite active management including strong opioids
7. Currently taking morphine, oxycodone, hydromorphone, buprenorphine, or transdermal fentanyl for daily, non-breakthrough pain management (i.e., maintenance opioid treatment) with no changes in dose in the 2 weeks preceding the Screening Visit (Day -7)
8. Completion of a daily diary in which the 24-hour AP score has been entered for at least 5 of the last 7 days preceding Day 1
9. Average of non-missing 24-hour AP scores over the last 7 days before the day of randomization is 4 or greater
10. If on gabapentin, pregabalin or selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants, no changes in dose in the 2 weeks preceding the Screening Visit (Day -7)
11. Willing to maintain existing analgesic medications, including maintenance opioid treatment, at same dose(s) and schedule for a minimum of 6 weeks following the Screening Visit (Day -7)
12. Able to take oral medication
13. If female subject of childbearing potential, a negative serum beta human chorionic gonadotropin (hCG) pregnancy test, performed at the Screening Visit (Day -7). Must be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following study drug exposure.
14. Willing and able to comply with protocol requirements for the duration of study participation
15. Contractual capability and signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
","Exclusion criteria:
1. Medical condition or illness other than solid neoplasm that would, in the opinion of the Investigator, preclude study participation or interfere with the assessment of pain
2. Abnormal liver or kidney function as defined by alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase in excess of 3 times the upper limit of normal, or chronic kidney disease worse than stage II (glomerular filtration rate <60 mL/min as calculated by Cockroft-Gault formula [(140-age) x (weight in kilograms) x (0.85 if female) / (72 x serum creatinine in mg/dl)])
3. Significant pain with neuropathic features which cannot be attributed to underlying malignancy
4. Proven hypersensitivity to flupirtine or one of the other ingredients
5. Cholestasis, pre-existing liver disease, or at risk of hepatic encephalopathy
6. Use of paracetamol-containing medications or carbamazepine
7. History of radiotherapy or a nerve block or other anesthetic procedure to the presumed site of nerve damage within 4 weeks preceding the Screening Visit (Day -7). Such procedures after the Screening Visit will necessitate withdrawal from the study.
8. If receiving a bisphosphonate medication, change in dose or frequency within 3 months preceding the Screening Visit (Day -7)
9. If receiving a hormonal contraceptive, change in dose or frequency within 3 months preceding the Screening Visit (Day -7)
10. Systemic radioisotope therapy within 1 month preceding the Screening Visit (Day-7)
11. Significant history of illicit drug or alcohol abuse
12. Current or previous (within 30 days of first study dosing) treatment with another investigational drug or participation in another clinical study
13. Change in chemotherapy regimen anticipated within 6 weeks following the Screening Visit
14. Pregnant or lactating females. Serum pregnancy test must be performed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start;
15. Known hepatitis B or C or HIV infection
16. Not suitable for study participation in the Investigator’s judgment
17. Previous participation in this study
18. Patient is a relative of, or staff directly reporting to the Investigator
19. Patient is an employee of the sponsor
20. Subject is committed under official or judicial order
21. Patient with a known diagnosis of myasthenia gravis
22. Patient with a known diagnosis of tinitus
23. Patients with metastatic liver disease (accompanied by change in LFTs to >2x ULN)
",Main Objective: The primary objective of this study is to explore the overall analgesic efficacy of flupirtine administered in combination with opioids for a period of 5 weeks.;Secondary Objective: Secondary objectives of this study are to:
- Investigate the safety and tolerability of flupirtine administered in combination with opioids;
- Investigate the efficacy of flupirtine using various secondary measures of efficacy.
;Primary end point(s): Change in the 11-point Likert scale for average daily pain from the baseline mean pain score (the mean of non-missing daily diary entries for average pain during the 7 days before randomization) to the final mean pain score (the mean of last 7 daily diary entries for average pain during the Treatment Period);Timepoint(s) of evaluation of this end point: Day 36 visit,"Secondary end point(s): - Percentage of subjects achieving at least 30% improvement from baseline based on the primary efficacy endpoint;
- Physician and Subject Global Assessment of study drug;
- Change in the 11-point Likert scale from the baseline mean pain score to the mean pain score during each week of the Treatment Period;
- Percentage of subjects achieving pre-specified pain reduction thresholds (e.g., 20% to 100%); and
- Opioid consumption, BPI (short-form), average pain the past 24 hours, least pain in past 24 hours, and worst pain in past 24 hours.
;Timepoint(s) of evaluation of this end point: Day 36 visit",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2011-10-18,NA,2011-05-16,300,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2011,NA,FALSE,FALSE,TRUE
23158,NA,NA,NCT03021213,NCT: NA ICTRP: 2016-10-27 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,2,NA,"no AM, no metric, no measure",3,NA,"no AM, no metric",NCT: NA ICTRP: 0 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2017-01-13,NA,2017-01-31,2017-06-30,Observational,Treating Heart Failure With Enhanced External Counterpulsation (EECP),"Treating Heart Failure With Enhanced External Counterpulsation (EECP): Prospective, Multi-centric Observational Cohort Study",Withdrawn,NA,0,Actual,"Charite University, Berlin, Germany",Systolic and diastolic heart function,Ergometric power increase;Subjective health Status - Mental Health Composite Score;Subjective health Status - Physical Health Composite Score;Organ complications,EECP,Treating Heart Failure With Enhanced External Counterpulsation (EECP),"Treating Heart Failure With Enhanced External Counterpulsation (EECP): Prospective, Multi-centric Observational Cohort Study",,,Observational,,,2016-10-27,2017-01-20,0,Withdrawn,"Charite University, Berlin, Germany",NULL,germany,NULL,"
Inclusion Criteria:
- Patients with heart failure (NYHA II-IV)
1. with optimal medical therapy
2. caused by ischemic or non-ischemic cardiomyopathy
- EECP-Therapy and Treatment in the Cardio Centrum Berlin or Charité - University
Medicine Berlin
- Aged 18 to 100 years
- Offered patient information and written informed consent
Exclusion Criteria:
- Participation in another interventional trial
- Acute coronary syndrome < 4 weeks prior to enrollment
- Operation < 4 weeks prior to enrollment
- Stroke < 4 weeks prior to enrollment
- Clinically significant disease with hospitalization
- Aortic valvular heart disease = moderate
- Aortic aneurysm
- clinically relevant severe cardiopulmonal diseases
- Resting RR > 160/90mmHg
- Thrombose, Thrombophlebitis < 8 weeks prior to enrollment
- Peripheral artery occlusive disease = Stadium II
- Acute Heart failure
- Pathological bleeding tendency
- Arrhythmias, which interfere with Triggering of the EECP
- Other diseases, that inhibit EECP-Treatment (e.g. Spinal disc herniation)
- Accommodation in an institution due to an official or judicial order
- Women: pregnancy or lactation
",NULL,Systolic and diastolic heart function,Ergometric power increase;Subjective health Status - Mental Health Composite Score;Subjective health Status - Physical Health Composite Score;Organ complications,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-01-31,2016-10-27,2016-10-27,0,Observational,TRUE,TRUE,TRUE,NA,TRUE,TRUE,TRUE,TRUE,NA,TRUE,2017,NA,TRUE,FALSE,FALSE
34497,NA,NA,EUCTR2015-000905-38,NCT: NA ICTRP: 2015-10-28 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no time frame,5,NA,NA,NCT: NA ICTRP: 426 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2015-05-07,NA,2015-05-31,2019-04-25,Interventional,"Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)","A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma",Completed,Phase 3,430,Actual,Pharmacyclics LLC.,Progression Free Survival (PFS);Overall Survival (OS),Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.;Overall Response Rate;Clinical Benefit Response;Carbohydrate Antigen 19-9 (CA19-9) Response;Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).;Rate of Venous Thromboembolic Events (VTE),PCYC-1137-CA,"Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)","A Randomized, Multicenter, Double-blind, Placebo-controlled, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2015-05-04,2015-05-20,430,Completed,Pharmacyclics LLC.,NULL,"united states;belgium;france;germany;italy;korea, republic of;spain;united kingdom;belgium;france;germany;italy;korea, republic of;spain;united kingdom;united states",Drug: Ibrutinib;Drug: Gemcitabine;Drug: Nab-paclitaxel,"
Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
2. Stage IV disease diagnosed within 6 weeks of randomization
3. Adequate hematologic function:
- Absolute neutrophil count (ANC) =1.5 x 109/L
- Platelet count =100 x 109/L
- Hemoglobin =9 g/dL
4. Adequate hepatic and renal function defined as:
- AST and/or ALT =5.0 x upper limit of normal (ULN) if liver metastases, or =3 x
ULN without liver metastases
- Alkaline phosphatase <3.0 x ULN or =5.0 x ULN if liver or bone metastases present
- Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of
non-hepatic origin, such as hemolysis)
- Estimated Creatinine Clearance =30 mL/min
5. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
6. KPS =70.
7. Eastern Cooperative Oncology Group (ECOG) 0-1
Exclusion Criteria:
1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or
cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.
2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in
case of clinical suspicion of central nervous system involvement).
4. Major surgery within 4 weeks of first dose of study drug.
5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
",NULL,Progression Free Survival (PFS);Overall Survival (OS),Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine.;Overall Response Rate;Clinical Benefit Response;Carbohydrate Antigen 19-9 (CA19-9) Response;Patient-reported Outcome (PRO) by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).;Rate of Venous Thromboembolic Events (VTE),NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-05-31,2015-05-04,2015-05-04,430,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,NA,TRUE,FALSE,TRUE
34796,NA,NA,EUCTR2015-004699-31,NCT: NA ICTRP: 2016-02-03 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,2,NA,"no AM, no time frame, no metric",NCT: NA ICTRP: 364 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2016-03-17,NA,2016-05-19,2021-12-31,Interventional,A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer,"Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer","Active, not recruiting",Phase 2,306,Actual,Eli Lilly and Company,Progression Free Survival (PFS),"Overall Survival (OS);Proportion of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR);Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR);Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab;PK: Plasma Concentration of Merestinib;Number of Participants with Treatment-Emergent Anti-Ramucirumab Antibodies;Change from Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep);Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)",I3O-MC-JSBF;2015-004699-31;16329,A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer,"Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 2,2016-03-14,2016-05-19,306,"Active, not recruiting",Eli Lilly and Company,NULL,"united states;argentina;australia;austria;belgium;czechia;denmark;france;germany;hungary;japan;korea, republic of;mexico;russian federation;spain;sweden;taiwan;turkey;united kingdom;argentina;australia;austria;belgium;czechia;denmark;france;germany;hungary;japan;korea, republic of;mexico;russian federation;spain;sweden;taiwan;turkey;united kingdom;united states;czech republic;italy",Drug: Ramucirumab;Drug: Merestinib;Drug: Cisplatin;Drug: Gemcitabine;Drug: Placebo Oral;Drug: Placebo IV,"
Inclusion Criteria:
- Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Have a histologically or cytologically confirmed diagnosis of non-resectable,
recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic
cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
- Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
- Have adequate biliary drainage.
- Have adequate organ function.
- Males and females are sterile, postmenopausal, or compliant with a highly effective
contraceptive method.
- Female participants of childbearing potential must have a negative serum pregnancy
test within 7 days prior to first dose.
- Are willing to provide blood/serum/plasma and tumor tissue samples for research
purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for
participation in this study, unless restricted per local regulations.
Exclusion Criteria:
- Previous systemic therapy for locally advanced or metastatic disease is not allowed.
- Have a history of or have current hepatic encephalopathy of any grade, or ascites of
Grade >1, or cirrhosis with Child-Pugh Stage B or higher.
- Have ongoing or recent (=6 months) hepatorenal syndrome.
- Have had a major surgical procedure or significant traumatic injury including
nonhealing wound, peptic ulcer, or bone fracture =28 days prior to randomization.
- Anticipate having a major surgical procedure during the course of the study.
- Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord
compression.
- Within 6 months prior to randomization, have had any arterial thrombotic event,
including myocardial infarction, unstable angina, cerebrovascular accident, or
transient ischemic attack.
- Have an uncontrolled arterial hypertension with systolic blood pressure =150 or
diastolic blood pressure =90 millimeters of mercury (mm Hg) despite standard medical
management.
- Have a previous malignancy within 5 years of study entry or a concurrent malignancy.
- Have a history of gastrointestinal perforation and/or fistulae within 6 months prior
to randomization.
- Have a known allergy or hypersensitivity reaction to any of the treatment components.
- Have a history of uncontrolled hereditary or acquired thrombotic disorder.
- Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases
or secondary effects of cancer that induce a high medical risk and/or make assessment
of survival uncertain.
- Have mixed hepatocellular biliary tract cancer histology.
- Have a corrected QT interval >470 milliseconds as calculated be the Fredericia
equation.
",NULL,Progression Free Survival (PFS),"Overall Survival (OS);Proportion of Participants with a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR);Proportion of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR);Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab;PK: Plasma Concentration of Merestinib;Number of Participants with Treatment-Emergent Anti-Ramucirumab Antibodies;Change from Baseline in Functional Assessment of Cancer Therapy Hepatobiliary Questionnaire (FACT-Hep);Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2016-05-19,2016-03-14,2016-03-14,306,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2016,NA,TRUE,FALSE,TRUE
26698,NA,NA,ACTRN12613000119796,NCT: NA ICTRP: 2013-01-31 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,5,NA,NA,NCT: NA ICTRP: 632 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,nil,Neoadjuvant chemotherapy with nab-paclitaxel in women with HER2-negative high-risk breast cancer,"Phase III, open-label, randomised trial of nab-paclitaxel versus paclitaxel in patients with HER2-negative, not metastatic unilateral breast cancer who are at risk of disease recurrence to assess treatment response ",NULL,NULL,Interventional,Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;,Phase 3,2013-01-31,2013-08-01,632,"Active, not recruiting",Fondazione Michelangelo,Breast Cancer Research Centre of Western Australia (BCRC-WA),australia;italy;poland;germany;russian federation;austria;singapore,"Subjects will receive 4 cycles of Abraxane (Investigational Product) (125mg/m2) intravenously over 30 min given week 1, 2 and 3 followed by 1 week rest or the comparator. This will be followed by 4 cycles of anthracycline-containing chemotherapy (AC/EC or FEC - based on clinician decision). AC Doxorubicin 60mg/m2, Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks; EC Epirubicin 90mg/m2, Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks; FEC Fluorouracil 600mg/m2 Epirubicin 90mg/m2 Cyclophosphamide 600mg/m2 intravenously over 30 min given once every 3 weeks","Inclusion criteria: Patients with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. ECOG status 0 or 1.
Clinical stage should be either
- T2, T3, T4 disease, triple negative
- T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumour grade (G II-III).
Paraffin-embedded tumour block should be available for central confirmation of eligiblity criteria.
Written consent","Exclusion criteria: - contralateral breast cancer or presence of metastatic disease (exception: contralateral in situ ductal cancer)
- surgical axillary staging prior to study entry (exception: FNA of 1 axillary node is permitted, and, but not recommended, a pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes)
- pregnant and lactating women.
- women with childbearing potential unless appropriate contraception as described in protocol
- treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy for current diagnosed breast cancer.
- previous investigational product within 4 weeks of randomisation
- patients on therapy with a strong CYP3A4 ihibitor, and on therapy with warferin
- previous or concomitant malignancy of other type that could affect compliance.
- pre-existing motor or sensory neuropathy of Grade >1 for any reason
- patients with hypersensitivity due to drugs containing polyoxyethylene castor oil, or hardened castor oil.
- other serious illness or medical condition (examples included in the protocol)
- patients with a history of uncontrolled seizures, contral nervous system disorders or psychaitric disability judged to be clinically significant
- serious uncontrolled infections or poorly controlled diabetes mellitus
- Abonrmal laboratory values at baseline: ANC <1.5 x 109/L; platelet count < 100 x 109/L; Hb < 10g/dL; serum total bilirubin > 1.5xULN (except documented Gilbert's syndrome); ALT > 1.25 x ULN; serum creatinine > 1.5x ULN
- Baseline LVEF < 50% by echocardiography or MUGA scan
- ",The primary endpoint is to compare the rate of pathological Complete response (pCR) at surgery between abraxane and paclitaxel containing regimens.[At the time of surgery the absence of invasive disease in breast and nodes will be measured by histopathological examination. Surgery will occur between 3 to 5 weeks following last cycle of chemotherapy.],"to conduct molecular and clinical analyses to assess the presence of predictive markers of benefit [ Tumour tissue blocks at diagnosis and at surgery are mandatory. bloods/serum and plasma at baseline and after the chemotherapy treatment is optional. Further tissue samples at other time points are optional and defined in the protocol];Evaluation of the tolerability of the treatment regimens in the different study arms will be measured by using the Common Terminology Criteria for Adverse Events (CTCAE) verison 4.0[Duration of study up to 28 days after treatment (if surgery not performed) or surgery];Overall Survival in the study arms of abraxane vs paclitaxel[Overall Survival is defined as the time from randomisation to the date of death. Patients alive at the end of the study (10 years) will be considered at their last contact.];to compare Event Free Survival (Distant, Local, Regional) in the study arms of abraxane vs paclitaxel[ diagnosis of breast cancer progression during treatment or recurrence after surgery will be assessed by the investigator and confirmed by clinical, laboratory, radiological and/or histological findings. The protocol defines what is considered acceptable to confirm the event free survivals listed above. After surgery patients will be follwed up for 10 years after surgery. ];clinical Overall Response (cOR) after the first 4 cycles of abraxane vs paclitaxel, and after the entire pre-operative chemotherapy (before surgery) in the study arms of abraxane vs paclitaxel[after 4 cycles and before surgery by palpation of the breast and axilla.]",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2013-08-01,NA,2013-01-31,632,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2013,NA,FALSE,FALSE,FALSE
28159,NA,NA,CTRI/2010/091/001182,NCT: NA ICTRP: 2010-10-13 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no time frame,3,NA,"no time frame, no measure",NCT: NA ICTRP: 947 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,IMCL CP11-0805,Non Squamous Non-Small Cell Lung Cancer treatment with the Inhibitor of Epidermal growth factor receptor,"A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-CisplatinChemotherapy Plus IMC-11F8 Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Nonsquamous Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC)Acronym INSPIRE ",Nilam.Gawande@ppdi.com,Nilam.Gawande@ppdi.com,Interventional,"Randomized, Parallel Group, Multiple Arm Trial Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label",Phase 3,2010-10-13,2009-11-11,947,Not Applicable,ImClone LLC ImClone,PAREXEL INTERNATIONAL CLINICAL RESARCH PVT LTD,india;australia;austria;belgium;brazil;canada;croatia;france;germany;greece;hungary;italy;poland;portugal;romania;russian federation;serbia ;slovakia;south africa;spain;united kingdom;united states of america,"Intervention1: Necitumumab IMC-11F8 (16mg/ml), intravenous infusion:: Patients will receive IMC-11F8 (2 x 800 mg per three week cycle) until there is documentation of Progression of Disease, unacceptable toxicity, or withdrawal of consent, or until other withdrawal criteria are met.
Intervention2: Pemetrexed (500mg):: intravenous infusion 500mg/m² per cycle for 6 three-week cycles
Intervention3: Cisplatin ((0.5mg/ml):: intravenous infusion 75 mg/m² per cycle for 6 three-week cycles
Control Intervention1: Nil: Nil
","Inclusion criteria: ? Histologically- or cytologically-confirmed nonsquamous (adenocarcinoma/large cell or other) NSCLC
? Advanced (Stage IIIB or Stage IV) disease at the time of study entry
? Measurable or nonmeasurable (ie, evaluable) disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0
? Tumor tissue available for analysis of EGFR gene copy number and EGFR mutation status (minimum of eight slides, formalin-fixed, paraffin-embedded tissue).
","Exclusion criteria: ? Squamous cell NSCLC.
? Prior therapy with monoclonal antibodies, signal transduction inhibitors, or any
therapies targeting the EGFR, VEGF, or VEGFR
? Previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy ≥ 1 year prior to randomization are eligible)
? Major surgery or any investigational therapy in the 4 weeks prior to randomization
? Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
? Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants
",The primary outcome is the overall survival (OS) in patients with nonsquamous Stage IIIb or IV NSCLC treated with IMC-11F8 plus pemetrexed-cisplatin chemotherapy (Arm A) versus pemetrexed-cisplatin chemotherapy alone (Arm B) in the first-line metastatic setting.
Timepoint: Nil,To evaluate progression-free survival (PFS) in each arm.Timepoint: Nil,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-11-11,NA,2010-10-13,947,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2009,NA,FALSE,FALSE,FALSE
29355,NA,NA,NCT00021554,NCT: NA ICTRP: 2001-07-21 DRKS: NA,1,1,NA,2,1,NA,NA,1,1,NA,0,NA,NA,0,NA,NA,NCT: NA ICTRP: 525 DRKS: NA,NA,1,NA,NA,NA,"Sample size could not be determined from article, because in the article samples form two trials were combined.",NA,NA,NA,1,NA,ganzer Artikel,https://doi.org/10.1111/j.1468-1293.2010.00845.x,NA,2001-08-31,NA,NA,NA,Interventional,T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs,"A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Regimen Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)",Completed,Phase 3,525,NA,NIH AIDS Clinical Trials Information Service,NA,NA,T20-302;295D,T-20 in HIV Patients With Prior Drug Treatment and/or Resistance to Each of the Three Classes of Anti-HIV Drugs,"A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Regimen Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)",NULL,NULL,Interventional,"Intervention Model: Parallel Assignment, Primary Purpose: Treatment",Phase 3,2001-07-21,2001-07-20,525,Completed,Hoffmann-La Roche,Trimeris,australia;belgium;germany;italy;netherlands;spain;sweden;switzerland;united kingdom;australia;belgium;germany;italy;netherlands;spain;sweden;switzerland;united kingdom,Drug: Enfuvirtide,"
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV infected.
- Are at least 16 years of age.
- Have an HIV-1 RNA of at least 5,000 copies/ml.
- Have received anti-HIV drugs for at least 3 months and/or have written records of
resistance to at least 1 member of each of the 3 classes of anti-HIV drugs
(nucleoside reverse transcriptase inhibitors [NRTIs], nonnucleoside reverse
transcriptase inhibitors [NNRTIs], and protease inhibitors [PIs]). Resistance to
NNRTIs may not be required in certain cases.
",NULL,NULL,NULL,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2001-07-21,2001-07-21,525,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,NA,NA,TRUE,FALSE,FALSE
28190,NA,NA,ISRCTN60475069,NCT: NA ICTRP: 2010-09-15 DRKS: NA,1,1,NA,1,1,NA,NA,2,1,NA,4,1,no measure,4,0,"no AM; SCORAD was assessed according to article, but not reported",NCT: NA ICTRP: 632 DRKS: NA,606,1,1,NA,NA,NA,Double,No info,no_info,1,NA,ganzer Artikel,https://www.jacionline.org/article/S0091-6749(12)00266-7/fulltext,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,N/A,Prophylaxis of atopic and allergic manifestations and activation or modulation of the immune system by Pro-Symbioflor® treatment in newborns / small children from atopically pre-disposed parents.,"Prophylaxis by Pro-Symbioflor® of atopic and allergic manifestations and activation or modulation of the immune system in newborns / small children from atopically pre-disposed parents. Prospective, randomized, placebo-controlled, double-blind parallel group trial in 632 healthy newborns aged 4 weeks with increased risk for atopic dermatitis with repeated application of Pro-Symbioflor® t.i.d or placebo between 2 and 7 months of age and an observation period until the age of 3 years. ",marina.birr@charite.de,,Interventional,Prospective randomised placebo controlled double blind parallel group trial (Prevention),NULL,2010-09-15,2002-05-28,632,Completed,SymbioPharm GmbH (Germany),NULL,germany,"1. Intervention group:
Pro-Symbioflor® (verum): Bacterial lysate manufactured from 1,5 ? 4,5 x 10E+07 Enterococcus faecalis (DSM 16440) and 1,5 ? 4,5 x 10E+07 Escherichia coli (DSM 17252). 3x5 drops per day for 2 weeks then increased to 3x10 drops per day between 2 and 7 months of age.
2. Control group:
Pro-Symbioflor® (placebo): Culture medium without bacteria. 3x5 drops daily, for 2 weeks increased to 3x10 drops daily between 2 and 7 months of age.
The total duration of follow up will be 3 years.","Inclusion criteria: 1. Healthy male and female newborns aged 4 weeks
2. Regularly developed newborns - body weight: = 2500 g; gestational age > 37+0 weeks
3. No relevant illnesses since the birth (except transient Hyperbilirubinemia)
4. Positive atopic anamnesis with at least one parent (atopic dermatitis, bronchial asthma, allergic rhino-conjunctivitis)
5. Written informed consent by the parents as the legal representatives","Exclusion criteria: 1. Diseases that require immunosuppressive therapy (systemic administration of steroids or cyclosporine A)
2. Transfer to an intensive care unit after birth
3. Known immune disturbances or defects (Lymphopenia, Thrombopenia)
4. Concomitant medication or treatment (except for prophylaxis)
5. Inadequate ability or willingness of the parents to communicate or to cooperate
6. Family anamnesis of a congenital deficiency in immune defence",Incidence of atopic dermatitis during the treatment phase between the 4th and 31st life week under the prophylaxis with verum or placebo.,1. Incidence of atopic dermatitis after treatment and until end of 3 years
2. Time until the first manifestation of an AD
3. Severity of AD at manifestation of an eczema: SCORing Atopic Dermatitis (SCORAD) Score
4. Frequency and time until the appearance as well as severity of allergic/atopic manifestations in the gastrointestinal tract
5. Frequency and until the appearance as well as severity of an allergic/atopic manifestation in the airways
6. Frequency of a sensitization against food allergens
7. Induction / enhancement of a Th1-immune response
8. Toll-like-receptors
9. Safety pharmacological Investigations before and at the end of the treatment as well as the observation period
10. Adverse events,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2002-05-28,NA,2010-09-15,632,Interventional,FALSE,FALSE,NA,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2002,NA,FALSE,FALSE,FALSE
31204,NA,NA,EUCTR2007-002472-34,NCT: NA ICTRP: 2007-06-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,NA,NA,NA,NCT: NA ICTRP: 54 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-09-12,NA,2007-09-20,2009-05-27,Interventional,A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase,"A Single-arm, Two-stage Phase II Study of Lapatinib and Pemetrexed in the Second Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer",Completed,Phase 1,18,Actual,GlaxoSmithKline,OTR of the combination of lapatinib and pemetrexed,"anti-tumour activity of lapatinib in terms of overall response rate;anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival",EGF109462,A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase,"A Single-arm, Two-stage Phase II Study of Lapatinib and Pemetrexed in the Second Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer",;;;;,;;;;,Interventional,Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 1,2007-09-11,2007-09-20,18,Completed,GlaxoSmithKline,NULL,germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom;germany;italy;poland;united kingdom,Drug: Lapatinib;Drug: Pemetrexed;Drug: Lapatinib;Drug: Pemetrexed;Drug: Lapatinib;Drug: Pemetrexed;Drug: Lapatinib;Drug: Pemetrexed,"
INCLUSION CRITERIA:
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of 12 weeks;
- Have adequate organ function baseline laboratory values for inclusion;
EXCLUSION CRITERIA:
- History of other malignancy. Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis except for individuals who have previously treated CNS
metastases, are asymptomatic, and have had no requirement for steroids or antiseizure
medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy,
biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU
prodrug.
;
INCLUSION CRITERIA:
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of 12 weeks;
- Have adequate organ function baseline laboratory values for inclusion;
EXCLUSION CRITERIA:
- History of other malignancy. Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis except for individuals who have previously treated CNS
metastases, are asymptomatic, and have had no requirement for steroids or antiseizure
medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy,
biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU
prodrug.
;
INCLUSION CRITERIA:
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of 12 weeks;
- Have adequate organ function baseline laboratory values for inclusion;
EXCLUSION CRITERIA:
- History of other malignancy. Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis except for individuals who have previously treated CNS
metastases, are asymptomatic, and have had no requirement for steroids or antiseizure
medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy,
biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU
prodrug.
;
INCLUSION CRITERIA:
- Signed informed consent;
- Patients must be 18 years old;
- Subjects must have stage IIIB or IV NSCLC .
- Recurrent or persistent NSCLC following one previous line of cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
- Life expectancy of 12 weeks;
- Have adequate organ function baseline laboratory values for inclusion;
EXCLUSION CRITERIA:
- History of other malignancy. Subjects who have been disease-free for 5 years, or
subjects with a history of completely resected non-melanoma skin cancer or
successfully treated in situ carcinoma are eligible;
- Known history of or clinical evidence of central nervous system (CNS) metastases or
leptomeningeal carcinomatosis except for individuals who have previously treated CNS
metastases, are asymptomatic, and have had no requirement for steroids or antiseizure
medication for = 3 months prior to study enrollment.
- Peripheral neuropathy of grade 3 or higher;
- Concurrent cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy,
biologic therapy, hormonal therapy, and tumor embolization).
- Prior exposure to pemetrexed or an EGFR inhibitor in combination with 5-FU or a 5FU
prodrug.
",NULL,OTR of the combination of lapatinib and pemetrexed;OTR of the combination of lapatinib and pemetrexed;OTR of the combination of lapatinib and pemetrexed,"anti-tumour activity of lapatinib in terms of overall response rate;anti-tumour activity of lapatinib in terms of duration of response, time to response, time to progression, overall survival",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2007-09-20,2007-09-11,2007-09-11,18,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2007,NA,TRUE,FALSE,TRUE
35313,NA,NA,EUCTR2017-000372-29,NCT: NA ICTRP: 2018-01-07 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,NA,4,NA,NA,NCT: NA ICTRP: 354 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2018-01-16,NA,2017-12-18,2022-05-31,Interventional,Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis","Active, not recruiting",Phase 3,365,Actual,Corbus Pharmaceuticals Inc.,Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.,Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.;Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.;Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.,JBT101-SSc-002,Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis",;,;,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). ",Phase 3,2018-01-05,2017-12-18,365,"Active, not recruiting",Corbus Pharmaceuticals Inc.,NULL,"united states;australia;canada;germany;israel;japan;korea, republic of;netherlands;poland;spain;switzerland;united kingdom;australia;canada;germany;israel;japan;korea, republic of;netherlands;poland;spain;switzerland;united kingdom;united states",Drug: Lenabasum 5 mg;Drug: Lenabasum 20 mg;Other: Placebo oral capsule,"
Key Inclusion Criteria:
1. = 18 years of age at the time Informed Consent is signed.
2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
3. Disease duration = 6 years from the first non-Raynaud's symptom.
4. No new or increased doses of immunosuppressive medications within 8 weeks prior to
Screening.
Key Exclusion Criteria:
1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
2. Any of the following values for laboratory tests at Screening:
1. A positive pregnancy test in women of childbearing potential;
2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;
3. Neutrophils < 1.0 ×10^9/L;
4. Platelets < 75 ×10^9/L;
5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal
Disease (MDRD) Study equation;
6. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of
normal.
3. Any medical condition or concurrent medical therapies at Screening or Visit 1,
including a history of non-compliance with medical treatments, that may put the
subject at greater safety risk, influence response to study product, or interfere with
study assessments.
",NULL,Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.,Efficacy of lenabasum compared to placebo for the change from baseline in modified Rodnan skin score.;Efficacy of lenabasum compared to placebo for the change from baseline in Health Assessment Questionnaire - Disability Index.;Efficacy of lenabasum compared to placebo for the change from baseline in forced vital capacity.,2017-000372-29; NCT03398837,2018-05-30,no,Diffuse systemic sclerosis (10012977); Dermatopolymyositis; Spinal muscular atrophy and related syndromes,Arm 1 • Cohort 1: Lenabasum 5 mg twice per day (BID) (n = 118).
; Arm 2 • Cohort 2: Lenabasum 20 mg BID (n = 118).
; Arm 3 • Cohort 3: Placebo BID (n = 118).,Interventional,Randomized controlled trial,Blinded,Placebo|Active control (effective treament of control group),Parallel,III,To evaluate the efficacy of lenabasum compared to placebo in the treatment of diffuse cutaneous
systemic sclerosis (SSc) by assessing change from baseline in the modified Rodnan skin score
(mRSS) at Week 52. ,1. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing
the change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
score at Week 52
2. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing
the American College of Rheumatology (ACR) Provisional Combined Response Index in
diffuse cutaneous Systemic Sclerosis (CRISS) score at Week 52.
3. To evaluate the efficacy of lenabasum compared to placebo in the treatment of SSc by assessing
the change from baseline in the forced vital capacity (FVC) % predicted at Week 52.
,"Australia; Canada; France; Germany; Israel; Italy; Japan; Korea, Republic of; Netherlands; Poland; Spain; Switzerland; United Kingdom; United States",University Medical Center Erlangen; University Medical Center Köln; University Medical Center Berlin; University Medical Center Ulm; University Medical Center Heidelberg; Medical Center Bad Nauheim; University Medical Center Freiburg im Breisgau,2018-08-08,Actual,354,2020-09-23,"Key inclusion criteria at Screening:
1. ≥ 18 years of age at the time Informed Consent is signed.
2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
3. Disease duration ≤ 6 years from the first non-Raynaud’s symptom. If disease duration is > 3
years and ≤ 6 years, then mRSS ≥ 15.
","1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, such as:
a. On an organ transplantation list or has received an organ transplant.
b. Renal crisis within 1 year.
c. Lung disease requiring constant oxygen treatment.
d. Pulmonary hypertension requiring constant oxygen treatment.
e. Malabsorption or gastrointestinal dysmotility requiring total parenteral nutrition.
2. Any of the following values for laboratory tests at Screening:
a) A positive pregnancy test in women of childbearing potential.
b) Hemoglobin < 9 g/dL for males and < 8 g/dL for females.
c) Neutrophils < 1.0 ×109/L.
d) Platelets < 75 ×109/L.
e) Creatinine clearance in blood < 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation. Creatinine clearance may be assessed in a 24 hour urine collection to confirm eligibility (creatinine clearance ≥ 50 ml/min) if screening blood test is < 50 mL/min.
f) Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of normal.
3. New or increase in doses of any non-corticosteroid immunosuppressive medication within 8 weeks before Screening.
4. Oral prednisone > 10 mg per day or equivalent within 28 days before Visit 1.
5. A positive test for anti-centromere antibody at Screening.
6. Significant diseases or conditions other than SSc or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments. ","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial
to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis",Recruiting stopped after recruiting started ,"Corbus Pharmaceuticals; Universitätsklinikum ErlangenMedizinische Klinik 3; Universitätsklinikum Erlangen, Med. Klinik 3",[---]*; Joerg.Distler@uk-erlangen.de; Joerg.Distler@uk-erlangen.de,Arm 1 • Cohort 1: Lenabasum 5 mg twice per day (BID) (n = 118).
; Arm 2 • Cohort 2: Lenabasum 20 mg BID (n = 118).
; Arm 3 • Cohort 3: Placebo BID (n = 118).,2017-12-18,2018-01-05,2018-01-05,365,Interventional,FALSE,FALSE,FALSE,TRUE,FALSE,TRUE,FALSE,FALSE,TRUE,TRUE,2017,NA,TRUE,TRUE,TRUE
32692,NA,NA,EUCTR2010-021086-73,NCT: NA ICTRP: 2011-12-14 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,3,NA,NA,1,NA,NA,NCT: NA ICTRP: 73 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,Uni-Koeln-1443,HD-R3i - A study to improve the treatment of relapsed or refractory Hodgkin Lymphoma Patients using additional RAD001 (everolimus) to DHAP-chemotherapy,"HD-R3i - A prospective, randomized, placebo-controlled, international, multicenter phase I/II trial of RAD001 (everolimus) in combination with DHAP as induction therapy in patients with relapsed or refractory Hodgkin Lymphoma - HD-R3i ",ghsg@uk-koeln.de,ghsg@uk-koeln.de,Interventional,"Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
",Human pharmacology (Phase I): yesTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no,2011-12-14,2012-05-11,73,Not Recruiting,University of Cologne,NULL,germany,"
Trade Name: Afinitor 2,5mg
Product Name: everolimus
Pharmaceutical Form: Tablet
INN or Proposed INN: everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Trade Name: dexamethasone
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Dexamethasone
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cytarabine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Trade Name: Afinitor 5,0mg
Product Name: everolimus
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
","Inclusion criteria:
•Histologically confirmed early or late first relapsed classical HL (CR or CRu ? 3 months following the end of any polychemotherapy regimen +/- radiotherapy); patients with refractory HL (CR or CRu = 3 months following the end of first line treatment); patients with multiple relapse (any salvage therapy, no prior HDCT or SCT); pathology report based on original tumor tissue/lymph node is acceptable for meeting inclusion criteria, but tumor tissue (slides/block) must be available to be sent for central pathology to confirm diagnosis.
•Age at entry: 18-60 years.
•WHO activity index = 2
•Life expectancy of > 3 months with treatment.
•Absolute Neutrophil Count (ANC) = 1.0 x 109/L, platelets = 100 x 109/L, except for HL-related reduced values (e.g. in case of splenomegaly)
•Total bilirubin = 2 x ULN (if >2 x ULN direct bilirubin is required and should be =1.5 x ULN)
•Serum creatinine = 2 x ULN
•Normal organ function (except HL-related)
•Patient has given his/her written informed consent to participate in the trial
•Patient agrees to his personal data and tissue material, with due regard for data protection, being used for the study.
•Women of childbearing potential must have had a negative serum pregnancy test.
•Patients capable of swallowing intact study medication tablets and following directions regarding taking study drug, or have a daily caregiver who will be responsible for administering study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 73
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
•Liver disease as indicated by ASAT = 3 x ULN (= 5 x ULN if liver involvement is present)
•Patients who have a history of another primary malignancy = 3 years, with the exception of non-melanoma skin cancer, completely resected melanoma TNMpT1 and carcinoma in situ of uterine cervix.
•Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable.
•Patients unwilling to or unable to comply with the protocol.
•Patients who are using other investigational agents or who had received investigational drugs = 4 weeks prior to study drug start.
•Patients who had myelosuppressive chemotherapy or biologic therapy < 2 weeks to study inclusion.
•Patients who have previously received systemic mTOR inhibitor (sirolimus, temsirolimus, everolimus, etc).
•Patients with evidence of current central nervous system (CNS) involvement.
•Patients receiving chronic systemic immunosuppressive agents. Inhaled and topical steroids are acceptable. Patients may be receiving stable (not increased within the last month) chronic doses of corticosteroids with a maximum dose of 20 mg of prednisone or 10 mg of dexamethasone per day, if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica or adrenal insufficiency or asthma.
•Patients with active, bleeding diathesis.
•Patients with known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to any protocol medication.
•Patients receiving ongoing radiation therapy
•Patients with a psychiatric, addictive or any disorder which compromises their ability to give truly informed consent for participation in this study.
•Non-compliance: Refusal of blood products during treatment, epilepsy, drug dependency, change of residence to abroad, prior cerebral injury or similar circumstances that appear to make protocol treatment or long-term follow-up impossible
•Antiepileptic treatment
•poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN
•Patients with a known history of HIV seropositivity, chronic active hepatitis
•Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator
•Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
–unstable angina pectoris, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction = 6 months prior to first study drug, serious uncontrolled cardiac arrhythmia, cerebrovascular accidents = 6 months before study drug start
–severely impaired lung function as defined by spirometry (FEV1) and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
–any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study
–nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities whose thyroid function cannot be maintained in the normal range by medication
",Main Objective: PHASE I:
Primary:
•To identify the RPTD (recommended phase II dose) of RAD001 in combination with DHAP (Ever-DHAP)
PHASE II:
Primary:
•To demonstrate the efficacy of Ever-DHAP as induction therapy
;Secondary Objective: PHASE I:
Secondary:
•To assess toxicity and efficacy of Ever-DHAP
PHASE II:
Secondary:
•To compare efficacy and feasibility of Ever-DHAP and Placebo-DHAP
;Primary end point(s): PHASE I:
Primary:
•The rate of patients experiencing DLTs during 2 cycles of the combination therapy
PHASE II:
Primary efficacy endpoint:
•CR rate after induction therapy (CT-based only)
;Timepoint(s) of evaluation of this end point: Phase I:
During therapy
Phase II:
After 2 cycles of therapy,"Secondary end point(s): PHASE I:
Secondary:
•Adverse events during combination therapy
•Tumor related results of therapy or death
•Treatment administration (dose reductions of chemotherapy, duration of treatment)
•Time to recovery after end of treatment
•Stem cell mobilization
PHASE II:
Secondary efficacy endpoints:
•CT-based tumor status after induction therapy
•PET/CT-based tumor status after induction therapy
•Progression free survival (PFS)
•Overall Survival (OS)
;Timepoint(s) of evaluation of this end point: Phase I:
During and directly after therapy
Phase II:
Restaging after therapy and follow-up of two years",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2012-05-11,NA,2011-12-14,73,Interventional,TRUE,TRUE,NA,NA,TRUE,TRUE,FALSE,TRUE,NA,TRUE,2012,NA,FALSE,FALSE,TRUE
34430,NA,NA,EUCTR2014-005519-18,NCT: NA ICTRP: 2015-10-28 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,5,NA,NA,4,NA,no measure (success?),NCT: NA ICTRP: 400 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,15-02/GentaBet-S,Clinical study to compare two ointments with the active substance gentamicin and betamethason and one ointment without active substance for patients with bacterial infected eczema,"Double-blind, randomised clinical study comparing efficacy and safety of Gentamicin 0.1%_Betamethasone 0.05% Ointment (Test) vs. Diprogenta(R) Ointment (Reference) vs. Vehicle in patients with bacterial infected eczema ",anje.schmidt@dermapharm.de,anje.schmidt@dermapharm.de,Interventional,"Controlled: yesRandomised: yesOpen: noSingle blind: noDouble blind: yesParallel group: yesCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: yesPlacebo: yesOther: noNumber of treatment arms in the trial: 3",Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no,2015-10-28,2015-12-14,400,Not Recruiting,Dermapharm AG,NULL,germany,
Product Name: Gentamicin 0.1%_Betamethasone 0.05% Ointment
Pharmaceutical Form: Ointment
CAS Number: 5593-20-4
Other descriptive name: BETAMETHASONE DIPROPIONATE
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.05-
INN or Proposed INN: GENTAMICIN SULFATE
CAS Number: 1405-41-0
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Ointment
Route of administration of the placebo: Cutaneous use
Trade Name: Diprogenta Ointment
Product Name: Diprogenta Ointment
Pharmaceutical Form: Ointment
CAS Number: 5593-20-4
Other descriptive name: BETAMETHASONE DIPROPIONATE
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0.64-
INN or Proposed INN: GENTAMICIN SULFATE
CAS Number: 1405-41-0
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1.67-
,"Inclusion criteria:
1) Women and men = 18 years of age
2) Written consent to study participation after patient information by the investigator
3) Diagnosis of bacterial infected eczema based on clinical symptoms in a treatment area between 5 and 25 cm2
4) At least moderately severe clinical picture, i.e. patients must have a SIRS score = 8. The SIRS (Skin Infection Rating Scale) score is defined as the sum score of the 7 clinical parameters exudate/pus, crusting, erythema, tissue warmth, tissue oedema, itching and pain (each symptom assessed on a scale ranging from 0 (= absent) to 6 (= severe)).
5) Presence of the clinical parameter exudate/pus” (i.e. score = 1)
6) For women of childbearing potential : Application of an efficient contraceptive method (according to CPMP/ICH/286/95) during the whole study
7) For women of childbearing potential: Pregnancy test with negative result prior to study start
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
","Exclusion criteria:
1) Presence of a bacterial skin infection which, due to general criteria like severity or depth of the infection, cannot be treated adequately with topical antibiotics alone
2) Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster), dermatomycosis, lues or tuberculosis of the skin, inoculation reactions, rosacea or rosacea-like dermatitis
3) Necessity of application of the study medication in the area around the eyes
4) Necessity of application of the study medication in the area around the ears
5) Necessity of application of the study medication near mucous membranes
6) Systemic therapy with antibiotics within the last 4 weeks before study inclusion
7) Systemic therapy with immunosuppressants or corticoids or medication with neuromuscular blocking effect within the last 2 weeks before study inclusion
8) Local treatment in the test area within the last week before study inclusion
9) Known intolerance or hypersensitivity against gentamicin or other aminoglycosids, betamethasone or other glucocorticoids, or any of the other ingredients in the study medications
10) Advanced renal insufficiency
11) Concomitant diseases like e.g. Myasthenia gravis, Parkinson or other neuromuscular disorders
12) Other severe acute or chronic concomitant disease with severe impairment of the general condition
13) Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
14) Necessity for a concomitant medication with neuromuscular blocking effect, e.g. benzodiazepines, or other central or peripheral muscle relaxants
15) Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
16) Reasonable doubt concerning the co-operation of the patient
17) Participation in another clinical study within the last 30 days prior to inclusion in this study
18) Participation in this study at an earlier date
19) Women with existing or intended pregnancy or during lactation
",Main Objective: Assessment of efficacy and safety of a new ointment with gentamicin 0.1% and betamethasone dipropionate 0.05% in comparison with the approved preparation Diprogenta® Ointment and the underlying vehicle in patients with bacterial infected eczema.;Secondary Objective: See also E5 (endpoints);Primary end point(s): The primary endpoint of the study is the clinical success rate at the end of treatment (Day 7 or Day 14).
Clinical treatment success is defined as follows:
- SIRS score < 8
- and score value for activity parameters exudate / pus = 0
- and no need for further treatment of study diagnosis;Timepoint(s) of evaluation of this end point: Day 7 and Day 14,"Secondary end point(s): 1) Change of the SIRS score between visits, and between EOT and final examination
2) Number (percentage) of patients with bacteriological success at main examination (EOT)
3) Evaluation of therapeutic success at EOT by the investigator and by the patient
4) Evaluation of overall therapeutic success by the investigator at the final examination visit
5) Number (percentage) of patients with clinical relapse / re-infection at the final examination visit
;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2015-12-14,NA,2015-10-28,400,Interventional,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2015,NA,FALSE,FALSE,TRUE
27690,NA,NA,CTRI/2011/11/002115,NCT: NA ICTRP: 2011-11-09 DRKS: NA,1,1,NA,1,1,r,Missing exact cutpoints for disease scores,2,1,NA,4,1,no measure,4,1,no AM,NCT: NA ICTRP: 1053 DRKS: NA,741,1,1,2,1,NA,"""Double"", but should be triple according to details (Participant, Investigator, Outcome Assessor and Date-entry Operator)",Double,ok,1,NA,ganzer Artikel,https://doi.org/10.1002/art.39856,NA,2010-12-17,NA,2010-12-31,2015-05-31,Interventional,Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus,"A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease",Completed,Phase 3,793,Actual,UCB Pharma,The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index,The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index;The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index;The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index;Change From Baseline in Daily Corticosteroid Dose at Week 24;Change From Baseline in Daily Corticosteroid Dose at Week 48,2010-018563-41;SL0009,Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus,"A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease",,,Interventional,"Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). ",Phase 3,2010-12-14,2010-12-20,793,Completed,UCB Pharma,NULL,"united states;australia;belgium;brazil;bulgaria;czechia;estonia;france;germany;india;israel;italy;korea, republic of;lithuania;mexico;puerto rico;romania;russian federation;spain;taiwan;united kingdom;australia;belgium;brazil;bulgaria;czechia;estonia;france;germany;india;israel;italy;korea, republic of;lithuania;mexico;puerto rico;romania;russian federation;spain;taiwan;united kingdom;united states;czech republic",Drug: Epratuzumab;Drug: Epratuzumab;Drug: Placebo,"
Inclusion Criteria:
- Positive antinuclear antibodies (ANA) at Screening (Visit 1)
- Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College
of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
- Active moderate to severe SLE activity as demonstrated by the British Isles Lupus
Assessment Group Index (BILAG)
- Active moderate to severe SLE disease as demonstrated by SLEDAI total score.
- On stable SLE treatment regimen, including mandatory corticosteroids and
immunosuppressants or antimalarials
Exclusion Criteria:
- Subjects who are breastfeeding, pregnant, or plan to become pregnant
- Subjects with active, severe SLE disease activity which involves the renal system
- Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric
element scoring BILAG level A disease.
- Subjects with the evidence of an immunosuppressive state
- Subjects who, in the opinion of the investigator, are at a particularly high risk of
significant infection
- History of malignant cancer, except the following treated cancers: cervical carcinoma
in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
- Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit
1).
- Subjects with history of infections, including but not limited to concurrent acute or
chronic viral hepatitis B or C
- Subjects with substance abuse or dependence or other relevant concurrent medical
condition
- Subjects with history of thromboembolic events within 1 year of screening Visit.
- Subjects with significant hematologic abnormalities
- Subject has received treatment with other anti- B cell antibodies within 12 months
prior to screening (visit 1)
- Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs
(NSAIDs) within 12 weeks prior to screening (Visit 1)
- Subject has previously participated in this study or has previously received
epratuzumab treatment.
",NULL,The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index,The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index;The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index;The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index;Change From Baseline in Daily Corticosteroid Dose at Week 24;Change From Baseline in Daily Corticosteroid Dose at Week 48,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-12-31,2010-12-14,2010-12-14,793,Interventional,FALSE,FALSE,TRUE,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2010,NA,TRUE,FALSE,TRUE
30031,NA,NA,EUCTR2005-003137-40,NCT: NA ICTRP: 2005-11-10 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,4,NA,no AM,4,NA,no AM,NCT: NA ICTRP: 824 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2007-02-16,NA,2006-02-28,2007-09-30,Interventional,A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome,"A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome",Completed,Phase 3,1429,Actual,Pierre Fabre Medicament,To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion,establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).;comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria,F02207GE302,A Multicentre Trial to Determine the Efficacy and Safety of Milnacipran in the Treatment of Fibromyalgia Syndrome,"A European Phase III, Multicentre, Double-blind, Randomised, Placebo-controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia Syndrome",,,Interventional,"Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment",Phase 3,2007-02-15,2006-02-20,1429,Completed,Pierre Fabre Medicament,NULL,czech republic;denmark;finland;france;germany;italy;norway;poland;portugal;romania;spain;sweden;united kingdom;czech republic;denmark;finland;france;germany;italy;norway;poland;portugal;romania;spain;sweden;united kingdom,Drug: milnacipran;Drug: Placebo,
Inclusion Criteria:
- patient with a diagnosis of fibromyalgia according to the 1990 American College of
Rheumatology (ACR) criteria
Exclusion Criteria:
- psychiatric illness
- depression of generalised anxiety disorder
- suicidal risk
- substance abuse
- active cardiac disease
- pulmonary dysfunction
- liver disease
- renal impairment
- autoimmune disease
- chronic inflammatory rheumatoid disease
- current systemic infection
- epileptic
- active cancer
- sleep apnea
- active peptic ulcer
- inflammatory bowel disease
- unstable endocrine disease
- for men : prostatic enlargement of genito-urinary disorders
- for women : pregnancy or breast feeding
,NULL,To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion,comparison of efficacy of treatment with milnacipran to placebo on additional secondary criteria;establishment of safety profile of treatment of milnacipran in patients with fibromyalgia syndrome (FMS).,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2006-02-28,2007-02-15,2007-02-15,1429,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2006,NA,TRUE,FALSE,TRUE
35258,NA,NA,EUCTR2016-004825-17,NCT: NA ICTRP: 2017-11-09 DRKS: NA,1,NA,NA,2,NA,NA,NA,1,NA,NA,4,NA,NA,2,NA,NA,NCT: NA ICTRP: 25 DRKS: NA,NA,1,1,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,preTopic17,A Proof of concept study to investigate the effect of the antiviral medication Telbivudine in patients with inflammatory heart muscle disease caused by the Parvovirus,A Proof-of-concept study to investigate the Efficacy of Telbivudine Over Placebo in patients with Parvovirus-associated Inflammatory Cardiomyopathy - preTopic ,ahmed.elsanhoury@charite.de,ahmed.elsanhoury@charite.de,Interventional,"Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
",Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): yesTherapeutic confirmatory - (Phase III): noTherapeutic use (Phase IV): no,2017-11-09,2017-12-06,25,Not Recruiting,Charité Universitätsmedizin Berlin,NULL,germany,
Trade Name: Sebivo
Product Name: Sebivo
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
,"Inclusion criteria:
•Age 18–75 years
•Men and women
•Symptomatic heart failure in NYHA II/III stage
•LVEF = 50% (during the previous 3 months despite at least 6 weeks of heart failure treatment)
•Active B19 (mRNA positive) in endomyocardial
•Symptomatic heart failure therapy at stable doses for = 6 weeks
•Patients being capable of understanding the nature, importance, and scope of the clinical trial and being able to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
","Exclusion criteria:
•Recent cardiac surgery in = 6 weeks
•Major adverse cardiac events (MACE) = 6 weeks (e.g. ICD shock, myocardial infarction, stroke, revascularization)
•Cardiovascular procedure or hospitalization planned in the future
•Coronary artery disease (CAD) with need for revascularization
•Heart failure secondary to significant uncorrected primary valvular disease
•Co-morbidities associated with reduced life expectancy <1 year
•Inability to participate in exercise training (e.g. COPD GOLD III-IV, claudication =2b, other functional or mental limitations, significant cardiac ischemia, arrhythmias)
•Presence of persistent atrial fibrillation
•EMB examination showing active (mRNA positive) adeno or enterovirus (Coxsackievirus B3)
•Positive pregnancy test in female study participants
•Patients who take any of the prohibited concomitant medications: Immunosuppressant agents (e.g.: Corticosteroids, Cyclosporine), Interferon, anti-viral agents (e.g.: Valganciclovir, Lamivudine), and long-acting nitrates (e.g.: Isosorbide di/trinitrate).
•Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel.
•Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
•Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
•Patients who are dependent on sponsor, investigator or study site
","Main Objective: The main trial objective is to explore the efficacy of Telbivudine as a treatment for Parvovirus-induced inflammatory cardiomyopathy. It is expected that Telbivudine improves symptoms and cardiac functions. Further molecular studies within the trial will test the mechanism of action, whether it is B19 replication inhibition or whether there exist different/other mechanisms. Based on the results of the PreTOPIC study, Telbivudine will be classified as promising or not promising for further investigations in future large scale clinical trials.;Secondary Objective: The secondary trial objective is to demonstrate the safety of Telbivudine as a treatment for Parvovirus-induced inflammatory cardiomyopathy. Safety is considered as a secondary objective in the trial, since Telbivudine will be investigated at the same dose and regimen used for the approved indication, which has been shown to be safe.;Primary end point(s): The primary end point is the improvement of the patient's quality of life (QoL). QoL change will be assessed via the Minnesota Living with Heart Failure Questionnaire (MLWHFQ).;Timepoint(s) of evaluation of this end point: MLWHFQ: At baseline visit (day zero) and after 12 weeks of treatment.","Secondary end point(s): •Left ventricular ejection fraction
•Left ventricular end diastolic diameter
•Left ventricular global longitudinal systolic strain and systolic strain rate
•The 6-minute walk test
•New York Heart Association classification
•Reduction in the number of angina/chest discomfort episodes
•Parvovirus B19 replication; mRNA/DNA loads
•Myocardial inflammatory status (CD3+ cells)
•Skeletal muscle inflammatory status (CD3+ cells)
Safety endpoints:
Registration of exercise related adverse events and laboratory changes (Blood examination including (sodium, potassium, creatinine, haemoglobin, white and red blood cell counts, thrombocytes count, Nt-proBNP, creatine kinase MM and MB, Cardiac Troponin T, AST, ALT).
;Timepoint(s) of evaluation of this end point: •LVEF: at baseline (D0±1), week 12
•LVEDD: at baseline (D0±1) and week 12
•6MWT: at baseline (D0±1) and week 12
•NYHA classification: at baseline (D0±1) and at weeks 4,8, 12
•Number of angina/chest discomfort episodes: at baseline (D0±1) and weeks 4,8, 12
•Biopsy; B19 RNA/cDNA; CD3+ lymphocytes: at week 12
• Skeletal muscle biopsy: at baseline (D0±1) and at week 12
Safety endpoints (hematological and clinical laboratory analysis): Before the start of treatment (D0-X)±1) and at baseline (D0±1), week 4,8, 12",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2017-12-06,NA,2017-11-09,25,Interventional,FALSE,TRUE,NA,NA,TRUE,TRUE,FALSE,TRUE,NA,TRUE,2017,NA,FALSE,FALSE,TRUE
32256,NA,NA,EUCTR2009-013788-21,NCT: NA ICTRP: 2010-03-01 DRKS: NA,1,NA,NA,2,NA,NA,NA,2,NA,NA,2,NA,NA,4,NA,survival but no time frame,NCT: NA ICTRP: 300 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,2010-07-27,NA,2010-06-25,2016-09-26,Interventional,Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF),"A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis",Completed,Phase 2,198,Actual,Boehringer Ingelheim,Annual Rate of Decline in Forced Vital Capacity (FVC),"Overall Survival;Progression-Free Survival;Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease;Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation;Incidence of Patients With at Least One Acute IPF Exacerbation Over Time;Time to First Acute IPF Exacerbation;Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs",2009-013788-21;1199.35,Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF),"A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis",,,Interventional,Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). ,Phase 2,2010-07-06,2010-06-25,198,Completed,Boehringer Ingelheim,NULL,argentina;australia;belgium;brazil;bulgaria;canada;chile;china;czechia;france;germany;greece;hungary;ireland;italy;mexico;netherlands;portugal;russian federation;spain;united kingdom;argentina;australia;belgium;brazil;bulgaria;canada;chile;china;czechia;france;germany;greece;hungary;ireland;italy;mexico;netherlands;portugal;russian federation;spain;united kingdom;czech republic;el salvador,Drug: BIBF 1120;Drug: BIBF 1120;Drug: BIBF 1120;Drug: BIBF 1120,"
Inclusion criteria:
1. Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic
Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue
trial medication.
2. Written informed consent signed prior to entry into the study, in accordance with
International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local
law
3. Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent
trial)
Exclusion criteria:
1. Any disease that may put the patient at risk when participating in this trial.
Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may
qualify for participation even though exclusion criteria may have been met during the
course of participation in 1199.30, if the investigator's benefit-risk assessment
remains favourable.
2. Participation in another experimental clinical trial (except 1199.30) in the last 8
weeks.
3. Women who are breast feeding or of child bearing potential not using a highly
effective method of birth control for at least one month prior to inclusion and at
least 10 weeks after end of active therapy.
Highly effective methods of birth control are defined as those which result in a low
failure rate (i.e. less than 1 % per year) when used consistently and correctly, such
as implants, injectables, combined oral contraceptives, some Intra Uterine Devices
(IUDs), sexual abstinence or vasectomized partner. Female patients will be considered
of childbearing potential unless surgically sterilized by hysterectomy or bilateral
tubal ligation, or post-menopausal for at least two years.
4. Sexually active males not committing to using condoms during the course of the study
and at least 10 weeks after the end of active therapy (except if their partner is not
of childbearing potential).
5. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin,
hirudin etc).
6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel
etc) therapy.
7. Known or suspected active alcohol or drug abuse.
8. Patient not compliant in previous trial, with trial medication or trial visits.
",NULL,Annual Rate of Decline in Forced Vital Capacity (FVC),"Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs;Time to First Acute IPF Exacerbation;Incidence of Patients With at Least One Acute IPF Exacerbation Over Time;Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation;Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease;Progression-Free Survival;Overall Survival",NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2010-06-25,2010-07-06,2010-07-06,198,Interventional,FALSE,FALSE,FALSE,NA,FALSE,FALSE,FALSE,FALSE,NA,FALSE,2010,NA,TRUE,FALSE,TRUE
28686,NA,NA,ISRCTN96212539,NCT: NA ICTRP: 2009-02-27 DRKS: NA,1,NA,NA,2,NA,NA,NA,NA,NA,NA,1,NA,NA,NA,NA,NA,NCT: NA ICTRP: 100 DRKS: NA,NA,1,NA,NA,NA,NA,NA,NA,NA,1,NA,kein Artikel,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,01-09,Cardiopulmonary exercise testing and stress echocardiography as screening methods to detect pulmonary hypertension in patients with connective tissue diseases (CTD),Cardiopulmonary exercise testing and stress echocardiography as screening methods to detect pulmonary hypertension in patients with connective tissue diseases (CTD): an observational study ,,,Observational,Observational cross-sectional study (Diagnostic),NULL,2009-02-27,2009-06-01,100,Completed,Actelion (Germany),NULL,germany,"Patients affected by different forms of CDT will be included in the study. All patients will undergo CPET as well as stress echocardiography to detect secondary PH. Based on general disease characteristics and CPET results a diagnostic value will be assessed to provide a prospective measure for the early detection of PH in CDT. Second, it will attempted to assess a severity classification based on CPET and stress echocardiography.","Inclusion criteria: 1. Adults >=18 years, both males and females
2. Patients with all forms of CTD",Exclusion criteria: 1. Contraindications for CPET according to current guidelines
2. Congestive heart failure
3. Coronary heart disease
4. Myocardial infarction within the last 6 months
5. Pulomonary diseases other than CTD
6. Primary myopathy,Exercise capacity,No secondary outcome measures,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,NA,2009-06-01,NA,2009-02-27,100,Observational,FALSE,FALSE,NA,NA,TRUE,TRUE,FALSE,FALSE,NA,FALSE,2009,NA,FALSE,FALSE,FALSE