All-cause Mortality;Post-Procedure Hemodynamic Changes
Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator
Blood Pressure in mmHg
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
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).
Renal plasma flow
AUC0-24h,sema,day10, area under the semaglutide plasma concentration time curve from 0 to 24 hours after the 10th dosing
Phenotypic analysis of immune and nervous cell populations;Expression profil;Histological analysis
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
Proportion of patients with sustained remission
Number [N (%)] of subjects with drug-related adverse events
The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.
Change in pruritus (US);Bile acid reduction (EU and rest of world)
Muscle Rigidity
diagnostic accuracy of duplex ultrasound
Change in 2-Item Warmth Perception Measure (feet) from t1 to t3
Number of participants with Adverse Events
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
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.
Overall Subject Satisfaction the Day of Treatment After Daylight Session;Overall Subject Satisfaction at Week 12 Post-treatment
Comparison of percentage of responders by arm
Rate of completed drug sensitivity testing
Time to full enteral feeds (hours)
Quality of life - physical function
Change in nutrition adequacy in the ICU
Change in plasma oxalate
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)
Infective Endocarditis
RV function
Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen
Change in glycated hemoglobin (HbA1c) (%)
Incidence of dose limiting toxicities (DLTs)
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
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
Change From Baseline in Pre-dose FEV1
DQoL
The difference of prevalences after six months;The difference of prevalences after six months;The difference of prevalences after six months
Change in Endtidal CO2;Change in Nijmegen-Score;Change in Buteyko CP
Biomarker assessment
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
Event-free survival
Patients' adherence and persistence to carfilzomib therapy
Annual Height Velocity
Time to Improvement of Influenza Symptoms
Change in Neck disability index compared to baseline;Change in Neck disability index compared to baseline
Tip Placement efficiency measured by chest radiograph
Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24
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)
Ocular Surface Disease Index (OSDI©) questionnaire;Tear film stability
Occurrence of AAD
Effect on weight loss
Investigator Global Assessment;Percentage of total body surface area affected;Absence of related adverse events (ADR)
Disease-free interval
Change in VAS-F parameter
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
The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16
UDVA (Uncorrected Distance Visual Acuity)
Urinary leakage measured by pad test in grams
Number of retrieved oocytes after ovarian stimulation therapy;Clinical pregnancy rate
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Proportion of Participants Who Achieved American College of Rheumatology-20 (ACR20) Response
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score
Cumulative number of Gd-enhancing T1 lesions in brain MRI
Hamilton Depression Rating Scale;Hamilton Depression Rating Scale;Hamilton Depression Rating Scale
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
Rate of BV-free woman
Mean Change From Baseline in QTc Interval;Percentage of Participants With Maximum Change From Baseline in Electrocardiogram (ECG) Morphology
Measure the number of patients who had an increase of =20 points on the Total Improvement Score (TIS)
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
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
Combined endpoint of all-cause mortality and intervention for heart failure decompensation
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
Freedom from MACCE
Tinnitus Functional Index;Tinnitus Handicap Inventory
toxic death or relevant grade 4 toxicity;toxic death or relevant grade 4 toxicity;toxic death or relevant grade 4 toxicity
Number of participants with SAEs;Number of participants with AESIs
Overall Survival
Response, defined as patients alive and able to sit upright independently for at least 30 seconds
Change from baseline in daily average pain intensity in index bone metastasis cancer pain site
Transition rate
Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42
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
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
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
Time to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke
Ongoing Pregnancy Rate at the End of the Study;Ongoing Pregnancy Rate at the End of the Study
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
HbA1c (glycosylated haemoglobin)
All cause mortality at 3 years;All cause mortality at 3 years;All cause mortality at 3 years
Number of Participants Classified as Treatment Responders Within 12 Weeks
Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant.
Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).;Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).
left ventricular mass
NULL
Survival
NULL
Incisional hernia or burst abdomen within 12 months
Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time
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
NULL
bacteriologic response in the Bacteriologic per Protocol population
Overall Survival (OS);Progression-Free Survival (PFS)
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)
Rate of clinical remission;Rate of clinical remission;Rate of clinical remission
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
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.
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
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
Change from baseline to End-of-Study in 6-minute walk distance.
BV/TV and trab. Sp. measured by 3D pQCT device
incremental area under the triglyceride curve (iAUC-TG)
homogeneity of regional ventilation delay
Effectiveness and tolerance of/to the different therapies;Possible hospitalisation rate
serum sodium concentration
Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram),  physical examination, and safety laboratory variables.
Hoogland score to evaluate the inhibition of ovulation
Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
Proportion of Subjects Relapsed;Proportion of Subjects Relapsed
Extent of anesthesia;Efficacy of anesthesia
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Cumulative Percentage of Participants by Heavy Drinking Rate;Cumulative Percentage of Participants by Heavy Drinking Rate
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)
late lumen loss
Change in Number of Urinary Urge Incontinence Episodes;Change in Number of Urinary Urge Incontinence Episodes
Time to progression, the interval between the date of randomization and date of disease progression (death without progression is a competing risk)
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
Number of Participants Who Discontinued Before 6 Months of Treatment;Number of Participants Who Discontinued Before 6 Months of Treatment
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).
Pregnancy rate;Pregnancy rate
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
Percentage of Participants In Remission at Week 52;Percentage of Participants In Remission at Week 52;Percentage of Participants In Remission at Week 52
All-cause mortality and non-fatal heart failure events
overall survival
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)
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)
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)
Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ): Combined subscales Conduct Problem and Oppositional Behavior
Number of Participants Considered Responders as Assessed During the Maintenance Period;Number of Participants Considered Responders as Assessed During the Maintenance Period
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
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
Concentration time curve of bezlotoxumab;Adverse events (AEs);Discontinuing medication
Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review;Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
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
Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16
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.
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
Body weight after 52 weeks of treatment
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12);Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).;Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
Weight (kg);Quality of Life
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
Major Molecular Response (MMR) Rate at 12 Months;Major Molecular Response (MMR) Rate at 12 Months
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.
hypopituitarism of any degree
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
Ocular phenotype
Gastric emptying time, gastroesophageal reflux
Coronary and non-coronary cardiac findings by CCTA
Rate of clinical remission
Adverse effects at 2 months after treatment;Remission rate at 2 months after treatment
Changes in satiety scale, total and acylated ghrelin concentrations.
Serum lactate clearance
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
Dose Limiting Toxicities
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
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
Overall remission rate (partial and complete remission)
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
Change in cancer related fatigue
DINAMO TM: Change from baseline in HbA1c (%);DINAMO TM Mono: occurrence of treatment failure up to or at Week 26
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.
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
safety and tolerability of this diagnostic agent
NULL
Overall Survival as of 19 October 2015;Overall Survival as of 19 October 2015
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
Intubating Condition;Intubating Condition;Intubating Condition
Overall Survival;Overall Survival
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
Disease-free survival;Disease-free survival
body weight
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Rate of clinical remission at final/withdrawal visit;Rate of clinical remission at final/withdrawal visit;Rate of clinical remission at final/withdrawal visit
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
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
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
Bone turnover assessed by bone turnover parameters;Bone turnover assessed by bone turnover parameters;Bone turnover assessed by bone turnover parameters
DL DLT
Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival.
Radiological progression free survival (rPFS)
Ocular phenotype
The primary endpoint of the study is the time from randomisation to first documented AF/AFL recurrence
difference in cognitive function before and after physical stress
progression free survival
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.
Percentage of Participants With Clinically Significant Hypoglycemia
Ten meter walking test;Ten meter walking test
Mean Change in Hemoglobin Between Baseline and the Evaluation Period;Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
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®
Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels;Percentage Of Participants Who Achieved Transfusion Avoidance (TA)
NULL
24-h Area under the Curve at steady state (AUCt,ss)
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
Overall survival (OS)
High-sensitivity C-reactive protein (hs-CRP) as measure of systemic low-grade inflammation (cardiovascular risk)
rate of disease recurrence;rate of disease recurrence;rate of disease recurrence
Overall survival
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
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks;Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
Comparison of infection rate (wound, urinary tract, other), use of antibiotic treatment and length of hospital stay
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)
Sum of plasma areas under the curve of coffee phenolics
Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing
Occurrence of systemic or cutaneous malignancy
late toxicity
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)
NULL
To determine the safety and tolerability of repeated doses of NOX-A12 alone and in combination with filgrastim in healthy subjects.
Number of Participants With Treatment-emergent Adverse Events;Number of Participants With Treatment-emergent Adverse Events
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).
Hospital Anxiety and Depression Scale (HADS) anxiety score
Amputation-free survival
Performance of head-neck-coordination after surgery of the dorsal cervical spine
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
Improvement in the Psoriasis Area and Severity Index(PASI 75)from baseline at Week 12
The pain subscale score on the Western Ontario and McMasters Universities OA Index (WOMAC) taken at Day 28 compared to baseline
Incidence of Dose Limiting Toxicities
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
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
Overall Survival (OS);Overall Survival (OS);Overall Survival (OS)
Quality of Life Seattle Angina Questionnaire (SAQ);Major cardiovascular events
Occurrence of postoperative nausea and vomiting (PONV).
Retention of declarative memories after 0.75 Hz stimulation during SWS, vs after sham stimulation during SWS
Global Impression of Perceived Difficulties (GIPD) scale at baseline, Week 8 and Week 24
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)
Total number of dendritic cells in bronchoalveolar lavage fluid
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
Absence of major adverse events
To measure the plasma concentrations of POL7080
Median progression-free survival in routine clinical practice
Control rate
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.
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part
serial dexamethasone/CRH tests
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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
number of cumulus-oocyte-complexes
Major cardiovascular event
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
Progression-free survival within 2 years.
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.
Rate of major adverse cardiac events (MACE) within 30 days Copeptin vs. Control arm.
Number and indication of pre-hospital TXA applications during the investigation period
1. Quality of life <br>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)<br>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<br><br>2. Problem behavior: <br>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)<br>b) Observation of behavior (see above): appearance of problem behavior or other negative reactions<br><br>Assessment points: <br>6 weeks before start of the intervention (T0) <br>beginning of the intervention (T1)<br>directly after the intervention (T2)<br>follow-up  6 weeks after the end of the intervention (T3)
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.
Bleeding occurence or occurence of a thromboembolic event during the observation period of 9 month
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.<br>- 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.
Effectiveness of bexarotene monotherapy in various defined CTCL subtypes
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)
Leads the Matrixstimulation to a significant pain reduction compared to Baseline? Rating carried out in accordance of the Numeric Rating Scale (NRS)
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.
Concordance between current resistance analysis (evaluated by ultra deep sequencing from proviral DNA) and prior resistance pattern (historical test results)
Do the participants of the test group achieve better results (which means grades) than the control group or are there no differences?
Pulmonary embolism post operative during hospitalisation; diagnosis through clinic or ct-scan
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
Number of injections of study drug during the first year of treatment<br><br>Mean change from baseline in BCVA at month 12 (visit 13)<br>Visual acuity measured by ETDRS-charts
Incidence of drug-related hospital admissions
Knowledge about changes in well-being during an alcohol detoxification therapy by taking dietary-supportive supplement (Eusano formulation).<br>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.
incident daytime napping; incident sleep disturbances; trigger of acute myocardial infarction / of stroke
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)
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.
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.
Isoflavon plasma concentrations (LC-MS/MS), weekly
4 to 6 weeks prior surgery and 3 months after surgery the following endpoints will be evaluated:<br>Size of patellofemoral cartialge contact area will be determined using MRI at 0,10,20,30° of flexion.
progression-free survival rate at 6 months
Teamwork, measured by a questionnaire before and after the training (i.e. questionnaire on teamwork by Kauffeld)
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<br>inspecting the bladder under white light first, followed by blue light. Diagnostic performance is confirmed by biopsy.
Maxima of flow and pressure: Comparison between manual and machine ventilation
Analysis of innate immune cells and inflammatory mediators after Alemtuzumab therapy <br>(primary endpoint: macrophage populations, macrophage polarizations with immunohistochemistry and flow cytomerty,
10m Walking Test six months after end of the training period
To assess the effect of 3% Polidocanol on pruritus induced by Mucuna pruriens (cowhage) by itch intensity (VAS) within 30 minutes after Mucuna application
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)
mRS Shift
Tolerable expiratory flow limitation, rated by the volunteer directly after the experiment.
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.
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.
Diagnostic performance of QFR in comparison to iFR;QFR- iFR diagnostic grey zone calculation.
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
time till achiving walking ability (FAC 3): <br>daily measurement before start of study therapy until discharge<br><br>mobility (FSS-ICU):<br>before start of study therapy, directly after last study therapy unit and 3 weeks after the last examination
Prediction of progression-free interval and overall survival after initialization of antiangiogenic therapy based on baseline values and relative changes of CT perfusion parameters
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.
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
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)
The difference in event-free survival time will be compared between both arms
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.
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. <br>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.
Change in the Frequency of Annualised Days of Vaginal Bleeding
Progression-free survival (PFS) as assessed by Investigator
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.
Progression free survival
Treatment-related discontinuation of study treatment (Proportion of Patients)
Cure Rate at End of Therapy;Cure Rate at End of Therapy;Cure Rate at End of Therapy
AEs, laboratory parameters, vital signs.;Percentage of patients with laboratory confirmed clinical influenza
Rate of moderate and severe AECOPD (any cause)-analysis (87% CI);Rate of moderate and severe AECOPD (any cause) -Analysis (95% CI)
Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
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.
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<br>- lipid lowering potency of fluvastatin and simvastatin<br>- 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.<br>
Change from Baseline Cerebrovascular Reactivity (CVR) at 4 weeks of Monotherapy
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)
Percentage of Participants With Complete Cytogenetic Response (CCyR) at Year 1
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
Time to First Protocol-Defined Relapse in the Double-Blind Period
Main Objective: Safety Run-In Phase (Part 1):<br>• To evaluate the safety and tolerability of INCB039110 in combination with docetaxel and select their doses for further evaluation.<br>Randomized Phase (Part 2):<br>• 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.<br>;Secondary Objective: •To evaluate and compare the efficacy of the 2 treatment groups with respect to PFS.<br>•To evaluate and compare the efficacy of the 2 treatment groups with respect to overall tumor response and duration of response.<br>•To evaluate and compare disease control of INCB039110 in combination with docetaxel versus INCB039110 alone.<br>•To evaluate and compare the safety and tolerability of INCB039110 in combination with docetaxel versus docetaxel alone.<br>;Primary end point(s): Safety run-in Phase (Part 1):<br>- Safety and tolerability of the treatment regimens through assessment of AEs and changes in safety assessments including laboratory parameters.<br>- 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.<br><br>Randomized Phase (Part 2)<br>- 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.  <br>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.<br><br>
Absolute change in HbA1C from baseline to Month 6.
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)
<br>                1. Change in breast appearance at 24 months following start of radiotherapy (breast) measured by digital photograph<br>                2. Rectal bleeding at 24 months following start of radiotherapy (prostate) measured by patient-reported outcome toxicity questionnaires<br>                3. Dyspnea/breathlessness at 12 months following start of radiotherapy (lung) measured by patient-reported outcome toxicity questionnaires<br>
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.
Further tooth loss is measured at 5, 8, 10 and 15 years
Antibody concentrations against pneumococcal serotypes 1 month post-booster;Antibody concentrations against pneumococcal serotypes 1 month post-booster
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12;Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Freedom From Treatment Failure (FFTF) .
Percentage of Participants Achieving a Hemoglobin Response (HR) in Part 2
Long-term potentiation (LTP)-like plasticity measured with transcranial magnetic stimulation (TMS)
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
MRD negativity after induction Treatment (comparison of arms IA and IB);Progression Free Survival (PFS) after second randomization (arms IIA and IIB)
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.<br>
<br>                1. 17-item Hamilton Depression Rating Scale (HDRS-17)<br>                2. Montgomery-Asberg Depression Rating Scale (MADRS)<br>                3. Beck Depression Inventory (BDI)<br><br>                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.<br>
24-h Holter reporting
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
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 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)
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.<br>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.
Main Objective: Progression-free survival rate after 3 months (PFSR3), assessed by applying RECIST 1.1;Secondary Objective: ·Progression-free survival (PFS)<br>·Objective response rate (ORR) (i.e. CR or PR)<br>·Disease control rate (DCR) (i.e. CR, PR or SD)<br>·Overall survival (OS)<br>·Assessment of adverse events according to CTCAE 4.03<br>·Study therapy discontinuation rate due to cardiac toxicity <br>(i.e. due to LVEF reduction by more than 20% or LVEF <45%)<br>;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
Blood concentrations of small and large molecular weight uremic solutes
Peri-operative incidence of delirium, examined the whole time during the hospital stay of the patient.
Progression free survival;Progression free survival;Progression free survival
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)
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)
Main Objective: To investigate the ability of the ocrelizumab regimen in<br>combination with standard of care treatment (SOC) to induce a<br>complete or partial renal response, as assessed by renal function,<br>urinary sediment and proteinuria in patients with ISN/RPS or<br>WHO class III or IV lupus nephritis.;Secondary Objective: • To assess the safety and tolerability of ocrelizumab.<br>• To evaluate the PK, immunogenicity and PD parameters of ocrelizumab in this patient population.<br>• To evaluate corticosteroid sparing in patients receiving ocrelizumab.<br>• To evaluate the effect of ocrelizumab on extra-renal disease manifestations<br>• 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).<br><br>
Percentage of Participants Achieving Response;Percentage of Participants Achieving Response
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
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<br>· Assessment of global tolerability of three concentrations of chloramine-T-containing ointments (Muxan) by the investigator <br>· Characterisation of safety and tolerability of the investigational products considering Adverse Events in the study population<br>· 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)<br>· Assessment of prevention of progression to a classical lesion<br>· Time from treatment initiation to cessation of pain and other typical symptoms <br>· Occurrence of crusting<br>· Number of secondary infections<br>;Primary end point(s): Assessment of local tolerability (subjective symptoms, descriptive evaluation)
1. Agitation as measured with the Cohen-Mansfield Agitation inventory (CMAI)<br>2. Depression as measured with the Dementia Mood Assessment Scale (DMAS)<br>3. Apathy as measured with the Apathy Evaluation Scale (AES)<br>All primary outcomes are measured at baseline and at 12 months.
Pancreatic beta-cell function, insulin independency or change in insulin dose, metabolic control: most parameters at every 6 months.
Difference in progression-free survival (PFS) of patients treated with CS-1008 and paclitaxel/carboplatin versus placebo and paclitaxel/carboplatin
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:<br>- Investigate the safety and tolerability of flupirtine administered in combination with opioids; <br>- Investigate the efficacy of flupirtine using various secondary measures of efficacy. <br>;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
Systolic and diastolic heart function
Progression Free Survival (PFS);Overall Survival (OS)
Progression Free Survival (PFS)
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.]
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. <br/ ><br> <br/ ><br>Timepoint: Nil
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Incidence of atopic dermatitis during the treatment phase between the 4th and 31st life week under the prophylaxis with verum or placebo.
OTR of the combination of lapatinib and pemetrexed;OTR of the combination of lapatinib and pemetrexed;OTR of the combination of lapatinib and pemetrexed
Efficacy of lenabasum compared to placebo for the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis score.
Main Objective: PHASE I:<br>Primary:<br>•To identify the RPTD (recommended phase II dose) of RAD001 in combination with DHAP (Ever-DHAP)<br><br>PHASE II:<br>Primary: <br>•To demonstrate the efficacy of Ever-DHAP as induction therapy<br>;Secondary Objective: PHASE I:<br><br>Secondary:<br>•To assess toxicity and efficacy of Ever-DHAP <br><br>PHASE II:<br>Secondary:<br>•To compare efficacy and feasibility of Ever-DHAP and Placebo-DHAP<br>;Primary end point(s): PHASE I:<br>Primary:<br>•The rate of patients experiencing DLTs during 2 cycles of the combination therapy<br>PHASE II:<br>Primary efficacy endpoint:<br>•CR rate after induction therapy (CT-based only)<br>;Timepoint(s) of evaluation of this end point: Phase I:<br>During therapy<br><br>Phase II:<br>After 2 cycles of therapy
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). <br>Clinical treatment success is defined as follows:<br>- SIRS score < 8<br>- and score value for activity parameters exudate / pus = 0<br>- and no need for further treatment of study diagnosis;Timepoint(s) of evaluation of this end point: Day 7 and Day 14
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
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
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.
Annual Rate of Decline in Forced Vital Capacity (FVC)
Exercise capacity