<br>        Inclusion Criteria:<br><br>          -  Patients with Severe Aortic Stenosos who underwent BAV<br><br>        Exclusion Criteria:<br><br>          -  insufficient echocardiographic parameters before BAV<br>
<br>        Inclusion Criteria:<br><br>          -  Parkinson's patients<br><br>          -  Diagnostis of OH<br><br>          -  able to perform an ambulatory physiotherapy at Aachen University Hospital.<br><br>        Exclusion Criteria:<br><br>          -  deep brain stimulation or Pacemaker<br><br>          -  severe psychiatric disease<br><br>          -  severe heart disease<br><br>          -  severe vascular encephalopathy<br><br>          -  dementia<br><br>          -  pregnant or lactating women<br><br>          -  extreme pain or immobility<br>
<br>        Inclusion Criteria:<br><br>          1. Age: = 18 years and = 85 of both genders.<br><br>          2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior<br>             Cerebral Artery territories<br><br>          3. Baseline NIHSS = 7 and = 18<br><br>          4. Ability to initiate treatment within 8- 24 hours from stroke onset.<br><br>        Exclusion Criteria:<br><br>          1. Intracranial hemorrhage or hemorrhagic transformation<br><br>          2. Massive stroke<br><br>          3. Acute ischemic stroke in the posterior circulation<br><br>          4. Minor stroke<br><br>          5. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke<br><br>          6. Previous stroke in the last 6 months or pre-existing disability<br><br>          7. Patients with bleeding propensity or any condition in the oral cavity that prevents<br>             implantation<br><br>          8. Known cerebral arteriovenous malformation, cerebral aneurysm.<br><br>          9. Clinical suspicion of septic embolus.<br><br>         10. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)<br><br>         11. Serious systemic infection.<br><br>         12. Women known to be pregnant or having a positive or indeterminate pregnancy test.<br><br>         13. Patients with other implanted neural stimulator/ electronic devices (pacemakers).<br><br>         14. Life expectancy < 1 year from causes other than stroke.<br>
<br>        Inclusion Criteria: - Male, aged 18-64 years (both inclusive) at the time of signing<br>        informed consent. - Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive). -<br>        Considered to be generally healthy based on the medical history, physical examination, and<br>        the results of vital signs, electrocardiogram and clinical laboratory tests performed<br>        during the screening visit, as judged by the investigator. Exclusion Criteria: - Glycated<br>        haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening. - Use of<br>        tobacco and nicotine products, defined as any of the below: a) Smoking more than 5<br>        cigarettes or the equivalent per day. b) Not willing to refrain from smoking and use of<br>        nicotine substitute products during the in-house period(s). - History* of major surgical<br>        procedures involving the stomach potentially affecting absorption of trial products (e.g.,<br>        subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Presence of<br>        clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders<br>        potentially affecting absorption of drugs or nutrients, as judged by the investigator. -<br>        Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or<br>        medullary thyroid carcinoma*. - History* or presence of pancreatitis (acute or chronic).<br>        *As declared by subject.<br>
<br>        Inclusion Criteria:<br><br>        Informed consent<br><br>        Exclusion Criteria:<br><br>        No signed informed consent No blood from patients with weak general state of health<br>
<br>        Inclusion Criteria:<br><br>          -  Body weight of >= 40kg at Baseline Visit for participants between >=12 and <18 years<br>             of age<br><br>          -  Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to<br>             Baseline<br><br>          -  Active moderate to severe AD defined by Eczema Area and Severity Index (EASI),<br>             Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus<br><br>          -  Candidate for systemic therapy or have recently required systemic therapy for AD<br><br>          -  Documented history (within 6 months prior to Baseline) of inadequate response to<br>             topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented<br>             systemic treatment for AD or for whom topical treatments are otherwise medically<br>             inadvisable due to side effects or safety risks<br><br>        Exclusion Criteria:<br><br>          -  Prior exposure to any Janus kinase (JAK) inhibitor<br><br>          -  Unable or unwilling to discontinue current AD treatments prior to the study<br><br>          -  Requirement of prohibited medications during the study<br><br>          -  Other active skin diseases or skin infections requiring systemic treatment or would<br>             interfere with appropriate assessment of atopic dermatitis lesions<br><br>          -  Female subject who is pregnant, breastfeeding, or considering pregnancy during the<br>             study<br>
<br>        Inclusion Criteria:<br><br>          1. Written informed consent obtained from the subject<br><br>          2. Understanding of study procedures and willingness to abide by all procedures during<br>             the course of the study.<br><br>          3. Age range: 18-70 years<br><br>          4. Diagnosis of moderate to advanced FECD with central guttae and clinical relevant<br>             corneal endothelial cell loss of <1,000 cells/mm2 and clinical indication of surgical<br>             intervention (descemetorhexis) with or without accompanying cataract operation<br><br>          5. Reduced visual acuity, defined as BCVA <20/30<br><br>          6. Woman of childbearing potential must be using a highly effective method of birth<br>             control.<br>
<br>        Inclusion Criteria:<br><br>          -  Written informed consent<br><br>          -  Idiopathic Parkinson's disease (according to the British Brain Bank criteria<br>             (Hughes, 1992) including genetic forms<br><br>        Exclusion Criteria:<br><br>          -  Cognitive impairment (Mini Mental State Exam < 20)<br><br>          -  Suicidality, Psychosis<br><br>          -  Other severe pathological chronic condition that might confound treatment effects or<br>             interpretation of the data<br><br>          -  Pregnancy<br>
<br>        Inclusion Criteria:<br><br>          -  Signed informed consent of the parents<br><br>          -  Age 12-18 years<br><br>        Exclusion Criteria:<br><br>          -  Infectious disease with body temperature above 38 °C<br><br>          -  Skin damages at the lower legs/feet<br><br>          -  Known intolerance/ anaphylaxis to mustard or ginger preparations<br><br>          -  Cardiac arrhythmia<br><br>          -  Pregnancy<br><br>          -  Insufficient knowledge of the German language<br><br>          -  BMI percentile < 10% (for control group)<br>
<br>        Inclusion Criteria:<br><br>          -  Age = 18 years<br><br>          -  BMI = 25 kg/m2 without or after bariatric surgery<br><br>        Exclusion Criteria:<br><br>          -  refusal for participation<br><br>          -  age <18 years<br><br>          -  BMI <25 kg/m2<br>
<br>        Summary of Inclusion Criteria<br><br>          -  Age - Subject is at least 12 years old.<br><br>          -  Informed Consent - Subject reads the appropriate Participant Information Sheet and<br>             signs the Informed Consent Form (section 12.0).<br><br>          -  Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.<br><br>          -  Language - Subject reads and understands local language<br><br>          -  SMBG status confirmed<br><br>          -  Subject agrees to complete all aspects of the study<br><br>        Summary of exclusion criteria<br><br>          -  Conflict of Interest<br><br>          -  Pregnancy - Subject is pregnant (as confirmed by Subject)<br><br>          -  User Performance Accuracy Testing - Technical Expertise<br>
<br>        Inclusion Criteria:<br><br>          1. Diagnosis of a hematological malignancy: patients with leukemia, myeloma or lymphoma<br>             (e.g. ALL, AML, CLL, T-PLL, MCL, MM) who are in need of treatment and are willing to<br>             donate sufficient tumor material for ex-vivo drug sensitivity testing.<br><br>          2. The treating physician needs to indicate treatment.<br><br>          3. Measurable disease burden according to criteria as mention in section 3.<br><br>          4. Treatment must be scheduled and the patient must be eligible for the planed treatment<br>             as judged by the treating physician.<br><br>          5. Availability of 5x10e7 cells from peripheral blood draws, bone marrow aspirations or<br>             lymph node biopsies.<br><br>          6. Patient's written informed consent present.<br><br>          7. Ability to understand the nature of the trial and the trial related procedures and to<br>             comply with them.<br><br>        Exclusion Criteria:<br><br>          1. Any condition, which precludes initiation of treatment (e.g. breast feeding,<br>             pregnancy, infections, etc.) as judged by the treating physician.<br><br>          2. Any coexisting medical or psychological condition that would preclude participation in<br>             the required study procedures, as judged by the treating physician.<br><br>          3. No systemic cancer treatment except for cytoreductive pretreatment within 1 week of<br>             enrollment.<br>
<br>        Inclusion Criteria:<br><br>          1. Infants < 366 days,<br><br>          2. Ileostomy / Jejunostomy,<br><br>          3. double loop enterostomies and split enterostomies (with mucous fistula)<br><br>          4. Signed written informed consent obtained by parents/legal guardians and willingness of<br>             parents/legal guardians to comply with treatment and follow-up procedures of their<br>             child<br><br>        Exclusion Criteria:<br><br>          1. resection of ileocecal valve,<br><br>          2. colostomy,<br><br>          3. small bowel atresia,<br><br>          4. multiple ostomies (more than just an enterostomy and a mucous fistula),<br><br>          5. chromosomal abnormalities (if known at the time of randomization),<br><br>          6. Hirschsprung's disease,<br><br>          7. participation in another drug-intervention study<br><br>          8. Intestinal perforation due to a hemodynamic heart defect<br>
<br>        Inclusion Criteria:<br><br>          -  18 years of age or older<br><br>          -  Angiographically-confirmed multi-vessel coronary artery disease lesions with >=70% in<br>             at least 2 major epicardial vessels in 2 or more coronary artery territories (left<br>             anterior descending (LAD), circumflex (CX) and right coronary artery (RCA)) OR lesions<br>             >=50% in the left main (LM)<br><br>          -  Patients who, in the opinion of the investigator, are amenable for coronary surgery<br>             through either median sternotomy or minimally-invasive approach.<br><br>          -  Patients who are willing and able to comply with all follow-up study visits.<br><br>        Exclusion Criteria:<br><br>          -  <18 years of age<br><br>          -  concomitant cardiac procedure with CABG (e.g. valve repair or replacement)<br><br>          -  Previous cardiac surgery, mediastinal irradiation, or significant trauma to the chest<br><br>          -  Contra-indications for MICS CABG, including: severe pectus excavatum; severe pulmonary<br>             disease; hemodynamically significant left subclavian stenosis; morbid obesity; severe<br>             left ventricular (LV) dysfunction; no adequate PDA or marginal branch target; absence<br>             of femoral pulse bilaterally.<br><br>          -  Contraindications for conventional CABG via sternotomy<br><br>          -  Concomitant life-threatening disease likely to limit life expectancy to <2 years<br><br>          -  Emergency CABG with hemodynamic compromise<br><br>          -  Inability to provide informed consent.<br>
<br>        Inclusion Criteria:<br><br>          -  Age = 18 years<br><br>          -  Patients undergoing cardiac surgery<br><br>          -  Mechanically ventilated within 48 hours of ICU admission<br><br>          -  Stay on ICU > 72 hours<br><br>        Exclusion Criteria:<br><br>          -  None<br>
<br>        Inclusion Criteria:<br><br>          1. Signed a informed consent form or an assent<br><br>          2. Aged 12 or older with body weight = 35kg<br><br>          3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known<br>             underlying enteric disorder associated with malabsorption (e.g., bariatric surgery,<br>             Crohn's disease, short bowel syndrome, or other malabsorption syndrome)<br><br>          4. Urinary oxalate = 40mg/24h (normalized for body surface area in children) at Screening<br>             in patients with eGFR >15 mL/min/1.73m2<br><br>          5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening<br><br>          6. In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening<br><br>          7. Patients on dialysis, must be stable for greater than 3 months<br><br>        Exclusion Criteria:<br><br>        1. Unable or unwilling to discontinue Vitamin C supplementation<br>
<br>        Inclusion Criteria:<br><br>          -  patients referred for echocardiographic assessment of suspected endocarditis<br><br>        Exclusion Criteria:<br><br>          -  Unwillingness to participate.<br>
<br>        Inclusion Criteria:<br><br>          -  Measurable disease based on RECIST v1.1.<br><br>          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.<br><br>          -  Adequate organ function per protocol-defined criteria.<br><br>          -  Documentation of results from testing of human papilloma virus (HPV) status for<br>             oropharyngeal cancer.<br><br>          -  Baseline archival tumor specimen available or willing to undergo a prestudy treatment<br>             tumor core or excisional biopsy of a tumor lesion not previously irradiated, to obtain<br>             the specimen.<br><br>        Exclusion Criteria:<br><br>          -  Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous<br>             histologies as primary tumors.<br><br>          -  Disease progression within 6 months of completion of curatively intended systemic<br>             treatment for locoregionally advanced HNSCC.<br><br>          -  Use of protocol-defined prior/concomitant therapy.<br><br>          -  Known additional malignancy that is progressing or has required active treatment<br>             within the past 3 years.<br><br>          -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.<br><br>          -  Active autoimmune disease that has required systemic treatment in past 2 years.<br><br>          -  Known history of human immunodeficiency virus (HIV) infection. HIV testing is not<br>             required unless mandated by local health authority.<br><br>          -  Known history of or is positive for active hepatitis B (defined as hepatitis B surface<br>             antigen [HBsAg] reactive) or hepatitis C (defined as HCV RNA [qualitative] is<br>             detected).<br>
<br>        Inclusion Criteria:<br><br>          -  Patients in the study will be required to meet the following criteria, as ascertained<br>             from each of the automated databases:<br><br>          -  To have at least 1 year of enrolment in the database (DUS1 and DUS2).<br><br>          -  To have not been prescribed aclidinium bromide as monotherapy or with concomitant use<br>             of formoterol during the 6 months before the date of first prescription of aclidinium<br>             bromide (index date) in DUS1<br><br>          -  To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of<br>             formoterol, or as aclidinium/formoterol during the 6 months before the date of first<br>             prescription of aclidinium bromide (index date) in DUS2<br><br>        The same inclusion criteria will be applied for each of the comparator drugs.<br><br>        Exclusion Criteria:<br><br>          -  No age restrictions or exclusion criteria will be applied. This will allow for the<br>             characterisation of all users of aclidinium bromide and comparator drugs irrespective<br>             of the indication for which these medications are used. Identification of potential<br>             off-label use of aclidinium bromide in the paediatric and adult populations is one of<br>             the specific objectives of this DUS.<br>
<br>        Inclusion Criteria:<br><br>          -  A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.<br><br>          -  Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose<br>             ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor<br>             antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1<br>             and the doses have been stable for at least 4 weeks prior to Visit 1.<br><br>          -  FEV1 of =85% for patients aged =18 years. FEV1 of =90% for patients aged 12 to <18<br>             years.<br><br>          -  Daytime asthma symptom score (0 to 6 scale) of =1 per day during 4 of the last 7 days<br>             of the placebo run- in period.<br><br>          -  Total daily SABA use =1 puff per day during 4 of the last 7 days of the placebo run-in<br>             period.<br><br>          -  Demonstrated reversible airway obstruction.<br><br>          -  Asthma control questionnaire (ACQ) score = 1.5.<br><br>        Exclusion Criteria:<br><br>          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30<br>             days, whichever is longer.<br><br>          -  A resting QTcF (Fridericia) =450 msec (male) or<br><br>             =460 msec (female).<br><br>          -  Pregnant or nursing (lactating) women.<br><br>          -  Serious co-morbidities.<br><br>          -  Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or<br>             >2 mg of pitavastatin.<br><br>        Other protocol-defined inclusion/exclusion criteria may apply.<br>
<br>        Inclusion Criteria:<br><br>        Visiting a Brazilian secondary school<br><br>        Exclusion Criteria:<br><br>        Not visiting a Brazilian secondary school<br>      ;<br>        Inclusion Criteria:<br><br>        Visiting a Brazilian secondary school<br><br>        Exclusion Criteria:<br><br>        Not visiting a Brazilian secondary school<br>      ;<br>        Inclusion Criteria:<br><br>        Visiting a Brazilian secondary school<br><br>        Exclusion Criteria:<br><br>        Not visiting a Brazilian secondary school<br>      ;<br>        Inclusion Criteria:<br><br>        Visiting a Brazilian secondary school<br><br>        Exclusion Criteria:<br><br>        Not visiting a Brazilian secondary school<br>
<br>        Inclusion Criteria:<br><br>          -  Written informed consent, regular intake of prescribed asthma medication according to<br>             the AWMF scheme level 1, native speaker of german<br><br>        Exclusion Criteria:<br><br>          -  Participation in another study, comorbidities (heart diseases, cancer still under<br>             treatment, psychiatric diseases)<br>
<br>        Inclusion Criteria:<br><br>          1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.<br><br>          2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary),<br>             fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated<br>             chondrosarcoma, angiosarcoma.<br><br>          3. Age: 41 - 65<br><br>          4. Normal bone marrow, hepatic, cardiac and renal function<br><br>          5. Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide<br><br>          6. Written informed consent<br><br>        Exclusion Criteria:<br><br>          1. Planned chemotherapy and/or follow-up not feasible<br><br>          2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs,<br>             included in the present protocol<br><br>          3. Previous chemotherapy treatment for the current tumor<br><br>          4. White blood count < 3.0 x 109/L, and platelets < 100 x 109/L<br><br>          5. Creatinine clearance < 70 ml/min<br><br>          6. Left ventricular ejection fraction < 55% or fractional shortening rate of the left<br>             ventricle <28%<br><br>          7. Serum transaminases and bilirubin > 2 times the normal values<br><br>          8. ECOG performance status > 2<br><br>          9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma<br>             and Ewing's family tumors.<br>
<br>        Inclusion Criteria:<br><br>          -  Aged 18 years or older.<br><br>          -  Patients with MM who have received at least one prior therapy.<br><br>          -  Indication for treatment as assessed by the treating physician.<br><br>          -  Decision for second- or subsequent-line treatment with the combination therapy<br>             carfilzomib/ lenalidomide/ dexamethasone or carfilzomib/ dexamethasone<br><br>          -  Signed written informed consent.<br><br>          -  Criteria according to the current Summary of Product Characteristics (SmPC) for<br>             Kyprolis® (Carfilzomib)<br><br>        Exclusion Criteria:<br><br>          -  Contraindications according to the current SmPC for Kyprolis® (Carfilzomib)<br>
<br>        Inclusion Criteria:<br><br>          -  female, male<br><br>          -  adults = 18 years<br><br>          -  medical indication for Power-PICC-Line catheter implantation because of chemotherapy<br>             or parenertal nutrition<br><br>          -  in- and outpatients<br><br>        Exclusion Criteria:<br><br>          -  children and adolescents < 18 years<br><br>          -  systemic or local infection of the interventional location<br><br>          -  known allergy to used material<br><br>          -  general contraindication of Power-PICC-Line catheter implantation<br><br>          -  nonexistent sinus rhythm (5)<br>
<br>        Inclusion Criteria:<br><br>          -  = 18 years of age<br><br>          -  Psoriasis vulgaris<br><br>          -  Lesions on trunk and/or extremities of at least mild severity<br><br>          -  Treatment with Enstilar® planned<br><br>          -  Signed informed consent to participate<br><br>        Exclusion Criteria:<br><br>          -  Enrolled in any interventional clinical trial<br><br>          -  Ongoing or recent treatment with any systemic psoriasis<br><br>          -  Ongoing or recent treatment with UV-therapy<br><br>          -  Ongoing or previous treatment with Enstilar®<br><br>          -  Psoriasis of scalp only<br><br>          -  Other forms of psoriasis, e.g. erythrodermic or pustular psoriasis<br><br>          -  More than 30% of surface area affected by psoriasis<br><br>          -  Any contraindications or known allergies to Enstilar® or its ingredients<br><br>          -  Incapacitated patients under institutionalized care<br>
<br>        Inclusion Criteria:<br><br>          -  Any gender and age above 18 years.<br><br>          -  Refractive lens exchange (RLE) or cataract surgery.<br><br>          -  Healthy corneas, not treated surgically.<br><br>          -  Patients willing to have surgery in both eyes in a short period of time (within 2<br>             weeks).<br><br>          -  Patients request to receive the IOL MINI WELL READY implant<br><br>        Exclusion Criteria:<br><br>          -  Previous corneal surgery (i.e. pterygium, refractive surgery).<br><br>          -  Eye diseases determining a probable postoperative visual acuity < 20/40.<br><br>          -  Pseudoexfoliation.<br><br>          -  Abnormal pupil size and position.<br><br>          -  Use of contact lens 30 days before the preoperative visit.<br><br>          -  Corneal warpage.<br><br>          -  Predicted postoperative corneal astigmatism higher than 1 D.<br>
<br>        Inclusion Criteria:<br><br>          -  Minimum age of 18 Years<br><br>          -  Voluntarily agreement to participate in this study<br><br>          -  filled in and signed Informed Consent<br><br>          -  release of medical records for regulatory or research purposes<br><br>          -  clinically organ-confined prostate cancer<br><br>          -  recommended and planned robot-assisted radical prostatectomy<br><br>        Exclusion Criteria:<br><br>          -  Participation in other interventional trials that could interfere with the present<br>             study<br><br>          -  International Prostate Symptom Score (IPPS) > 18<br><br>          -  History of radiation or chemotherapy<br><br>          -  History of transurethral prostate resection<br><br>          -  unable to provide informed consent<br><br>          -  unwillingness to storage and forwarding of pseudonymous data<br>
<br>        Inclusion Criteria:<br><br>          -  Women with a medical indication for an ovarian stimulation therapy for the purposes of<br>             an IVF or ICSI.<br><br>          -  First-time ovarian stimulating therapy for an IVF or ICSI.<br><br>          -  Ovarian stimulation therapy exclusively with Ovaleap®.<br><br>          -  GnRH antagonist protocol.<br><br>          -  Body-Mass-Index (BMI) < 30 kg/m2.<br><br>          -  Duration of menstrual cycle 24 - 35 days.<br><br>               -  Additional criteria apply, please contact the investigator for more information<br><br>        Exclusion Criteria:<br><br>          -  Combined application of IVF and ICSI<br><br>          -  Ovarian hyperstimulation with Ovaleap® with a consecutive social freezing.<br><br>          -  Polycystic ovary syndrome (PCOS).<br><br>          -  Endometriosis (AFS (American Fertility Society) grade 3 and 4).<br><br>          -  Uterine myoma (intramural > 4 cm, submucosal).<br><br>          -  Hydrosalpinx (on one side or both sides).<br>
<br>        Inclusion Criteria:<br><br>          -  Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa<br>             (HS) for at least 1 year (365 days) prior to the Baseline visit<br><br>          -  Participant must have at least 3 distinct anatomical regions involved with<br>             inflammatory (also termed 'active') HS lesions; plus<br><br>               -  either one axilla or one inguinal region (limited to the inguino-crural fold and<br>                  adjacent areas) that requires excisional surgery, and<br><br>               -  with at least one of the other affected HS regions (e.g., contralateral inguinal<br>                  region, buttocks, inframammary region) rated as Hurley Stage II or III<br><br>          -  Participant must have a total abscess and inflammatory nodule (AN) count of greater<br>             than or equal to 3 at the Baseline visit within the HS non-surgical sites<br><br>          -  The HS surgical site must contain at least one active HS lesion<br><br>          -  The HS surgical site must require excisional surgery and is large enough to require<br>             healing by secondary intention as assessed by the designated surgeon<br><br>        Exclusion Criteria:<br><br>          -  Participant has a draining fistula count of greater than 20 at the Baseline visit<br><br>          -  Participant requires surgery at any anatomical site other than an unilateral axilla or<br>             inguinal region site<br><br>          -  Participant requires surgical management prior to Week 13<br><br>          -  Participant requires, based on the designated surgeon's assessment, excisional surgery<br>             with primary closure as the method of closure being most beneficial for the<br>             participant<br>
<br>        Main Inclusion Criteria:<br><br>          -  For male or female with reproductive potential, use of reliable means of<br>             contraception;<br><br>          -  RRMS according to the 2010 revised McDonald criteria;<br><br>          -  Disease activity characterised by at least one documented relapse within the last 12<br>             months and /or at least one Gd-enhancing T1 lesion at selection or evidenced within<br>             the last 3 months;<br><br>          -  EDSS score < 6.0.<br><br>        Main Exclusion Criteria:<br><br>          -  Patients suffering from Secondary Progressive MS and Primary Progressive MS at<br>             screening;<br><br>          -  Pregnant and nursing women.<br>
<br>        Inclusion Criteria:<br><br>          -  Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection<br><br>          -  Documented as treatment naive or experienced with a prior regimen consisting of<br>             Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response<br><br>          -  Absence of cirrhosis<br><br>          -  Screening laboratory values within defined thresholds<br><br>          -  Must use specific contraceptive methods if female of childbearing potential or<br>             sexually active male<br><br>        Exclusion Criteria:<br><br>          -  Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)<br><br>          -  Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination<br>             with pegylated interferon (PegIFN) or IFN-free<br><br>          -  Current or prior history of clinical hepatic decompensation<br><br>          -  History of clinically significant illness or any other medical disorder including<br>             cardiovascular conditions that may interfere with individual's treatment, assessment<br>             or compliance with the protocol<br><br>          -  Pregnant or a nursing female<br>
<br>        Inclusion Criteria:<br><br>          -  signed informed consent<br><br>          -  age > 18<br><br>          -  confirmed diagnosis of infective endocarditis or valvular heart disease<br><br>          -  scheduled surgical Intervention with CPB use<br><br>        Exclusion Criteria:<br><br>          -  glucocorticoid dosage above Cushing threshold<br><br>          -  severe neutropenia (below 1000/mm3)<br><br>          -  immunosuppression or immunomodulatory therapy<br><br>          -  pregnancy<br>
<br>        Inclusion Criteria:<br><br>          -  Personally signed and dated informed consent document.<br><br>          -  Randomized and treated with subcutaneous investigational product in a tanezumab study<br>             and has completed the study or been withdrawn from the study.<br><br>          -  Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab<br>             study.<br><br>          -  Willing and able to comply with scheduled visits and other study procedures.<br><br>        Exclusion Criteria:<br><br>        - None.<br>
<br>        Inclusion Criteria:<br><br>        Idiopathic Parkinson's disease < 7 years duration<br><br>        Modified Hoehn and Yahr Scale Stages I through III<br><br>        Age greater than or equal to 30 years old<br><br>        Patients or their partners must use adequate contraceptive methods<br><br>        Patients who are willing and able to comply with scheduled visits, treatment plan,<br>        laboratory tests, and other study procedures and do not plan on traveling extensively<br>        during the study<br><br>        Exclusion Criteria:<br><br>        Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or<br>        degenerative diseases.<br><br>        Levodopa received for 1-year accumulated interval in the last two years.<br><br>        Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days<br>        prior to baseline.<br><br>        Unstable dose regimes of hypnotics, anxiolytics or antidepressants<br><br>        Dementia<br><br>        History of stereotaxic brain surgery, psychosis or active epilepsy within past year.<br><br>        Participation in clinical trial within the previous 30 days.<br><br>        Malignant melanoma or history of melanoma<br><br>        Significant medical or pshychiatric condition<br>
<br>        Inclusion Criteria:<br><br>          -  Male or female, age greater than or equal to 45 years at the time of signing informed<br>             consent<br><br>          -  Body mass index (BMI) greater than or equal to 27 kg/m^2<br><br>          -  Have established cardiovascular (CV) disease as evidenced by at least one of the<br>             following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic<br>             stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by<br>             intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or<br>             peripheral arterial revascularization procedure, or amputation due to atherosclerotic<br>             disease<br><br>        Exclusion Criteria:<br><br>          -  Any of the following: myocardial infarction, stroke, hospitalisation for unstable<br>             angina pectoris or transient ischaemic attack within the past 60 days prior to the day<br>             of screening<br><br>          -  HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central<br>             laboratory at screening<br><br>          -  History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)<br>
<br>        Inclusion Criteria:<br><br>          -  Type 2 diabetes<br><br>          -  OAD monotherapy<br><br>          -  OAD combination therapy<br><br>          -  Therapy with OAD and basal insulin<br><br>          -  Conventional insulin therapy with premixed insulin<br>
<br>        Inclusion criteria:<br><br>          -  Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)<br>             FEV1/FVC ratio <70%.<br><br>          -  Current or ex-smokers with a smoking history of at least 10 pack-years.<br><br>        Exclusion criteria:<br><br>          -  Diagnosis of other respiratory disorders (including asthma).<br><br>          -  Requirement for long term oxygen therapy.<br>      ;<br>        Inclusion criteria:<br><br>          -  Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)<br>             FEV1/FVC ratio <70%.<br><br>          -  Current or ex-smokers with a smoking history of at least 10 pack-years.<br><br>        Exclusion criteria:<br><br>          -  Diagnosis of other respiratory disorders (including asthma).<br><br>          -  Requirement for long term oxygen therapy.<br>      ;<br>        Inclusion criteria:<br><br>          -  Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)<br>             FEV1/FVC ratio <70%.<br><br>          -  Current or ex-smokers with a smoking history of at least 10 pack-years.<br><br>        Exclusion criteria:<br><br>          -  Diagnosis of other respiratory disorders (including asthma).<br><br>          -  Requirement for long term oxygen therapy.<br>      ;<br>        Inclusion criteria:<br><br>          -  Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator)<br>             FEV1/FVC ratio <70%.<br><br>          -  Current or ex-smokers with a smoking history of at least 10 pack-years.<br><br>        Exclusion criteria:<br><br>          -  Diagnosis of other respiratory disorders (including asthma).<br><br>          -  Requirement for long term oxygen therapy.<br>
<br>        Inclusion Criteria:<br><br>        A patient can be considered for eligibility to participate if he/she:<br><br>          -  Has been consistently treated for chronic, noncancer-related pain with any oral,<br>             transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to<br>             screening<br><br>          -  Is diagnosed with OBD<br><br>          -  Is capable of utilizing an electronic diary to report daily spontaneous bowel<br>             movements (SBMs)<br><br>          -  Is willing to continue opioid therapy and discontinue the use of laxatives, stool<br>             softeners, and other concomitant medications affecting gastrointestinal motility<br>             throughout the study<br><br>        Exclusion Criteria:<br><br>        A patient cannot be considered for eligibility to participate if he/she:<br><br>          -  Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical<br>             bowel obstructions, bowel disorders, and constipation not arising from opioid use, but<br>             instead attributable to dietary, neurologic, congenital, or endocrine disorders,<br>             scleroderma, and/or for the management of drug addiction<br>
<br>        Inclusion Criteria:<br><br>          -  Clinical diagnosis hypertension (BP higher than 139/89)<br><br>        Exclusion Criteria:<br><br>          -  Antihypertensive pretreatment<br><br>          -  Contraindications against spironolactone<br><br>          -  Being unable to understand or comply with study procedures<br>
<br>        DISEASE CHARACTERISTICS:<br><br>          -  Histologically confirmed renal cell carcinoma<br><br>               -  Advanced metastatic disease that requires treatment<br><br>          -  Measurable disease (single bone lesions not included)<br><br>          -  No brain metastasis<br><br>        PATIENT CHARACTERISTICS:<br><br>        Age<br><br>          -  18 to 81<br><br>        Performance status<br><br>          -  WHO 0-1<br><br>        Life expectancy<br><br>          -  More than 12 weeks<br><br>        Hematopoietic<br><br>          -  WBC greater than 3,000/mm^3<br><br>          -  Platelet count greater than 100,000/mm^3<br><br>          -  Hemoglobin greater than 10 g/dL<br><br>        Hepatic<br><br>          -  Not specified<br><br>        Renal<br><br>          -  Not specified<br><br>        Cardiovascular<br><br>          -  No myocardial infarction within the past 6 months<br><br>          -  No unstable angina pectoris<br><br>        Other<br><br>          -  Not pregnant or nursing<br><br>          -  Fertile patients must use effective contraception during and for at least 6 months<br>             after study participation<br><br>          -  No other concurrent disease or prior malignancy that would preclude study treatments<br>             or comparisons<br><br>          -  No concurrent active infection requiring antibiotics<br><br>        PRIOR CONCURRENT THERAPY:<br><br>        Biologic therapy<br><br>          -  No prior biologic therapy<br><br>        Chemotherapy<br><br>          -  No prior chemotherapy<br><br>        Endocrine therapy<br><br>          -  No prior endocrine therapy<br><br>          -  No concurrent corticosteroids<br><br>        Radiotherapy<br><br>          -  At least 4 weeks since prior radiotherapy<br><br>        Surgery<br><br>          -  Prior resection of the primary tumor recommended but not required<br><br>          -  No prior major organ allografts<br>
<br>        DISEASE CHARACTERISTICS:<br><br>          -  Diagnosis of primary craniopharyngioma by MRI and CT scan (initial diagnosis)<br><br>               -  Patients with only cystic sellar or parasellar malformation (e.g., Rathke pouch<br>                  cysts or suprasellar cysts) are allowed but will undergo observation only<br><br>        PATIENT CHARACTERISTICS:<br><br>        Performance status<br><br>          -  Not specified<br><br>        Life expectancy<br><br>          -  Not specified<br><br>        Hematopoietic<br><br>          -  Not specified<br><br>        Hepatic<br><br>          -  Not specified<br><br>        Renal<br><br>          -  Not specified<br><br>        PRIOR CONCURRENT THERAPY: Not specified<br>
<br>        Inclusion Criteria:<br><br>          1. Preoperative Inclusion criteria:<br><br>               -  Age equal or greater than 18 years<br><br>               -  Expected survival time more than 12 months<br><br>               -  Patients undergoing primary and emergency midline laparotomy (patients  with<br>                  prior laparoscopy (not colon resections) or minor abdominal operation (e.g.<br>                  appendectomy, cholecystectomy, hysterectomy, sectio) may be included into the<br>                  trial)<br><br>               -  Suspected septic abdominal focus (e.g. perforated stomach ulcer, perforated<br>                  diverticulitis)<br><br>               -  Informed consent<br><br>          2. Intraoperative inclusion criteria before closure:<br><br>               -  Successful source control<br><br>               -  Abdominal lavage<br><br>        Exclusion Criteria:<br><br>          1. Preoperative exclusion criteria:<br><br>               -  Participation in another intervention-trial with interference of intervention<br>                  and outcome of this study<br><br>          2. Intraoperative exclusion criteria before closure:<br><br>               -  Planned re-laparotomy<br>
<br>        Inclusion Criteria:<br><br>        Histologically or cytologically confirmed diagnosis of adenocarcinoma of the<br>        pancreas;cancer which is unresectable, locally advanced or metastatic.<br><br>        Must have evidence of disease (clinical or radiological). Male or female, 18 years or<br>        older. Patients may have received prior radiation treatment for management of local disease<br>        providing that disease progression has been documented.<br><br>        All toxicities have resolved, and the last fraction of radiation treatment was completed at<br>        least 4 weeks prior to randomization.<br><br>        Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or<br>        gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'<br>
<br>        Inclusion Criteria:<br><br>          -  Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS)<br>             pharyngitis/tonsillitis and a positive rapid antigen detection test or positive<br>             culture of the pharynx or tonsils for GABHS<br><br>        Exclusion Criteria:<br><br>          -  Patients were excluded if they had treatment with any systemic antibiotic within the<br>             previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known<br>             carriers of GABHS.<br>
<br>        Inclusion Criteria:<br><br>          -  Aged at least 18 years<br><br>          -  Documented evidence of NSCLC (Stage IIIB/ IV disease)<br><br>          -  Disease progression or recurrence after both a platinum-based chemotherapy regimen and<br>             at least 1 additional regimen for treatment of NSCLC<br><br>          -  World Health Organization (WHO) Performance Status of 0 or 1<br><br>          -  Estimated life expectancy more than 12 weeks<br><br>        Exclusion Criteria:<br><br>          -  Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4<br><br>          -  Brain metastases or spinal cord compression unless asymptomatic, treated and stable<br>             (not requiring steroids)<br><br>          -  Active or prior documented autoimmune disease within the past 2 years<br><br>          -  Evidence of severe or uncontrolled systemic disease, including active bleeding<br>             diatheses or active infections including hepatitis B, C and HIV<br><br>          -  Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2<br>             from previous anti-cancer therapy<br><br>          -  Known EGFR TK activating mutations or ALK rearrangements<br><br>          -  Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous<br>             immunotherapy agent, or any unresolved irAE >Grade 1<br><br>          -  Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative<br>             colitis)<br>
<br>        Inclusion criteria:<br><br>          -  cytological confirmation of AML;<br><br>          -  relapsed disease following first CR of 1 month(30days)to 24 months(730days). The time<br>             from first relapse to study entry (start of first course of induction chemotherapy)<br>             must be no longer than 30days;<br><br>          -  confirmation of FLT-3 activating mutation positive status after point of initial<br>             relapse;<br><br>          -  aged 18 years or older;<br><br>          -  written informed consent;<br><br>          -  ability to understand and comply with study restrictions;<br><br>          -  no comorbid conditions that would limit life expectancy to less than 3 months;<br><br>          -  ECOG Performance Score of 0, 1,or 2;<br><br>          -  women must be neither pregnant nor lactating, and either of non-childbearing<br>             potential or using adequate contraception with a negative pregnancy test at study<br>             entry<br><br>        Exclusion criteria:<br><br>          -  bilirubin > 2x ULN;<br><br>          -  ALT/AST > 3x ULN;<br><br>          -  serum creatinine > 1.5 mg/dL;<br><br>          -  resting ejection fraction of left ventricle l < 45%(applies only to patients<br>             scheduled to receive mitoxantrone, etoposide, and cytarabine [MEC];<br><br>          -  untreated or progressive infection;<br><br>          -  any physical or psychiatric cdtn that may compromise participation in the study;<br><br>          -  known CNS involvement with AML;<br><br>          -  any previous treatment with a FLT-3 inhibitor;<br><br>          -  requires current treatment for HIV with protease inhibitors;<br><br>          -  active GI ulceration or bleeding;<br><br>          -  use of an investigational drug that is not expected to be cleared by the start of<br>             CEP-701 treatment<br>
<br>        Main inclusion criteria:<br><br>          -  Systemic Sclerosis diffuse or limited<br><br>          -  Significant Interstitial Lung Disease on HRCTscan<br><br>          -  DLco < 80% predicted<br><br>          -  Dyspnea on exertion<br><br>          -  Walk not limited by musculoskeletal reasons<br><br>        Main exclusion criteria:<br><br>          -  Interstitial Lung Disease due to other conditions than SSc<br><br>          -  End stage restrictive or obstructive lung disease<br><br>          -  Severe cardiac or renal diseases<br><br>          -  Significant pulmonary arterial hypertension<br><br>          -  Smoker (> 5cig./day)<br><br>          -  Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids<br>             (within 4 weeks of randomization)<br>
<br>        Inclusion Criteria:<br><br>          -  type 2 diabetes<br><br>          -  dietary therapy<br><br>        Exclusion Criteria:<br><br>          -  lipid-lowering therapy<br><br>          -  anti-hyperglycemic drug therapy<br>
<br>        Inclusion Criteria:<br><br>          -  acute lung injury, need for optimization of ventilatory settings<br><br>        Exclusion Criteria:<br><br>          -  preexisting chronical lung disease, pneumothorax, pace maker, hemodynamical<br>             instability, increased intracranial pressure<br>
<br>        Inclusion Criteria:<br><br>          -  Acute exacerbation of chronic bronchitis from Anthonisen type I or II<br><br>          -  FEV1 of < 50 %<br><br>          -  Patient must be ensured in the statutory health insurance<br><br>          -  Further contraindications of the prescribed pharmaceutical products must be<br>             considered<br><br>        Exclusion Criteria:<br><br>          -  Patients who change from one cohort to the other<br>
<br>        SIADH of any origin<br>
<br>        Inclusion Criteria:<br><br>          -  Active Rheumatoid Arthritis (RA) for 6 months or more.<br><br>          -  Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.<br><br>          -  Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg,<br>             inclusive.<br><br>          -  Males, unless surgically sterile, must use 2 effective methods of birth control from<br>             Day 1 through follow-up.<br><br>        Exclusion Criteria:<br><br>          -  History or presence of any clinically significant disease or disorder which has not<br>             been stable over the previous 3 months.<br><br>          -  History of liver disease, bilirubin elevations, or Gilbert's Syndrome.<br><br>          -  Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica,<br>             giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).<br><br>          -  Current, chronic pain disorders including fibromyalgia and chronic regional pain<br>             syndromes or chronic fatigue syndromes.<br><br>          -  Intramuscular steroid injection or intraarticular steroid injection within 1 month of<br>             enrollment.<br>
<br>        Inclusion Criteria:<br><br>          -  Healthy female volunteers<br><br>          -  age 18 - 35 years (smoker not older than 30 years, inclusive)<br><br>          -  ovulatory pre-treatment cycle<br><br>        Exclusion Criteria:<br><br>          -  Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g.<br>             history of venous or arterial thromboembolic disease)<br><br>          -  Regular intake of medication other than Oral Contraception<br><br>          -  Clinically relevant findings (blood pressure, physical and gynecological examination,<br>             laboratory examination)<br>
<br>        Inclusion Criteria:<br><br>          -  diagnosis of idiopathic multifocal, segmental or generalised dystonia<br><br>          -  duration of disease > 5 years<br><br>          -  age between 14 and 75 years<br><br>          -  relevant disability in activities of daily living despite optimal drug treatment<br><br>          -  informed consent signed by the patient<br><br>          -  For adolescents between 14 and 18 years: an additional informed consent signed by a<br>             legal guardian is necessary<br><br>        Exclusion Criteria:<br><br>          -  Mattis-Score < 120<br><br>          -  BDI > 25<br><br>          -  previous stereotactic brain surgery<br><br>          -  severe brain atrophy<br><br>          -  increased bleeding risk<br><br>          -  immunosuppression and increased risk of infection<br><br>          -  relevant cerebrovascular disease<br><br>          -  psychiatric disorders, which might interfere with the cooperation in the study<br><br>          -  other contraindications for surgery<br>
<br>        Inclusion Criteria:<br><br>          -  Single shot axillary block<br><br>        Exclusion Criteria:<br><br>          -  Lateral position not possible<br>
<br>        INCLUSION CRITERIA: To enter this study, patients must:<br><br>          -  Have a diagnosis of partial seizures<br><br>          -  Be willing to be hospitalized<br><br>          -  Weigh a minimum of 6.6 pounds<br><br>          -  Be taking a stable dose of one to two concomitant anti-epileptic medications<br><br>          -  Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or<br>             progressive neurological disease<br><br>          -  Have normal laboratory results<br><br>        EXCLUSION CRITERIA:  To enter this study, a patient must not have or be:<br><br>          -  Seizures caused by metabolic disturbance, toxic exposure, or active infection<br><br>          -  A primary diagnosis of generalized epilepsy (exception - secondarily generalized<br>             seizures)<br><br>          -  A history of status epilepticus within 30 days<br><br>          -  Seizures not related to epilepsy<br><br>          -  Frequent use of additional anti-epileptic medications to treat increases in seizures<br>             (for example: rectal diazepam)<br><br>          -  Taking felbamate within 6 months<br><br>          -  Serum sodium levels <135 mEq/L<br><br>          -  Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder<br>             requiring treatment/therapy<br><br>          -  A history of chronic infection (e.g., hepatitis or HIV)<br><br>          -  Significant electrocardiogram (ECG) abnormalities<br><br>          -  A nursing mother taking anti-convulsant drugs<br><br>          -  Previously demonstrated sensitivity/allergic reaction to Trileptal or related<br>             compounds<br><br>          -  Used experimental medication within 30 days of entering this study<br>
<br>        Inclusion Criteria:<br><br>          -  Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable<br>             or metastasized well-differentiated neuroendocrine tumor of the midgut<br><br>          -  curative surgery impossible<br><br>          -  two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic<br>             Resonance Imaging (MRI)<br><br>          -  Age = 18<br><br>          -  Karnofsky-index > 60<br><br>          -  written informed consent<br><br>          -  proliferation index for Ki67<br><br>        Exclusion Criteria:<br><br>          -  hypersensitivity to octreotide<br><br>          -  poorly differentiated or small cell neuroendocrine tumors<br><br>          -  primary tumor outside of the midgut<br><br>          -  prior treatment with somatostatin-analogue > 4 weeks<br><br>          -  prior treatment with alpha-interferon, chemotherapy, or chemoembolisation<br><br>          -  participation in any other clinical trial<br><br>          -  pregnancy or lactation<br><br>          -  no secondary malignancy in anamnesis; with the exception of patients without any<br>             manifestation of the secondary malignancy (without relapse) after curative therapy<br>             within the last five years<br><br>          -  severe decompensated organ malfunction (heart-, liver- insufficiency)<br><br>        Other protocol-defined exclusion criteria may apply.<br>
<br>        Inclusion Criteria:<br><br>          -  Male or female =18 years-of-age<br><br>          -  Multiple myeloma with evaluable disease<br><br>          -  Relapsing or having a progressive disease<br><br>          -  Karnofsky performance status > 50 %<br><br>          -  Life expectancy of at least 3 months<br><br>          -  Female of child-bearing potential must have a method of birth control and a negative<br>             serum or urine beta--human chorionic gonadotropin (ß-HCG) pregnancy test at screening<br>             and all through the study<br><br>          -  Male must use contraception<br><br>          -  Voluntary written informed consent<br><br>        Exclusion Criteria:<br><br>          -  Non-secretory multiple myeloma<br><br>          -  Platelet count < 40,000 X 10^9/L<br><br>          -  Absolute neutrophil count <1.0 X 10^9/L<br><br>          -  Creatinine clearance <30 mL/minute<br><br>          -  Peripheral neuropathy >= Grade 2<br><br>          -  Seropositive for HIV, or active hepatitis A, B or C infection<br><br>          -  Pregnant or breastfeeding female<br><br>          -  Patient has hypersensitivity to bortezomib, boron or mannitol<br><br>          -  Other investigational drugs<br><br>          -  Serious medical or psychiatric illness<br><br>          -  Previous or concurrent malignancies at other sites<br><br>          -  Poorly controlled hypertension, uncontrolled or severe cardiovascular disease or<br>             uncontrolled diabetes mellitus<br>
<br>        Inclusion Criteria:<br><br>          -  Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma<br>             (BCLC-B) for whom the decision has been taken by the investigator to prescribe<br>             Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients<br>             with large/multifocal HCC who do not have cancer related symptoms, macrovascular<br>             invasion or extrahepatic spread).<br><br>        Exclusion Criteria:<br><br>        - Prior targeted therapy for hepatocellular carcinoma.<br>
<br>        Inclusion Criteria:<br><br>          -  Age = 18 years old<br><br>          -  Persistent (= 1 month) or permanent atrial fibrillation. Persistent AF will be where<br>             obtaining and maintaining sinus rhythm is deemed either not worthwhile, or to be<br>             ineffective in the long term, or where both the patient and physician accept the<br>             presence of AF, where rhythm control intervention is, by definition no longer pursued.<br>             Permanent AF is defined as atrial fibrillation where sinus rhythm cannot be restored.<br><br>          -  NYHA class II , III or ambulatory class IV heart failure<br><br>          -  Left Ventricular Ejection Fraction (LVEF) = 35% by objective criteria such as<br>             echocardiography, or cardiac MRI<br><br>          -  QRS duration on 12-lead ECG = 120ms<br><br>          -  Able and willing to comply with all pre-, post- and follow-up testing and<br>             requirements.<br><br>        Exclusion Criteria:<br><br>          -  age < 18 years<br><br>          -  pregnancy<br><br>          -  previous AV nodal ablation<br><br>          -  Second or third degree AV block<br><br>          -  Inability to provide informed consent<br><br>          -  life expectancy less than 24 months due to co-morbid illness other than heart failure<br>             erg cancer, end-stage renal disease, liver failure<br><br>          -  Paroxysmal Atrial Fibrillation that self terminates within 7 days<br>
<br>        Inclusion Criteria:<br><br>          -  Male and female subjects with a diagnosis of type 2 diabetes mellitus who either have<br>             never had a major adverse cardiac event (MACE) diagnosed before or who had a MACE<br>             diagnosed at least 6 months ago, but who, according to the judgement of the treating<br>             general practitioner, do not receive any hyperlipidemic therapy. Major adverse<br>             cardiac events (MACE) include myocardial infarction, coronary angioplasty, coronary<br>             artery bypass graft or other revascularization procedures.<br><br>        At Screening:<br><br>        Visit 1 (week -4):<br><br>          1. Male patients aged >35 and =75 years and postmenopausal female patients =75 years<br>             with a diagnosis of type 2 diabetes mellitus<br><br>          2. Patients have been euthyroid for at least six months<br><br>          3. Written informed consent obtained<br><br>             At Visit 2 (week 0):<br><br>          4. LDL cholesterol =130 mg/dl (3.3 mmol/l ) and <190 mg/dl (4.9 mmol/l)<br><br>          5. Triglycerides <150 mg/dl (1.69 mmol/l ) and <600 mg/dl (11.3 mmol/l)<br><br>          6. Sum of LDL-5 and LDL-6 cholesterol =25 mg/dl (0.65 mmol/l)<br><br>          7. Follicle stimulating Hormone (FSH) >30 U/l in female patients aged <60 years or FSH<br>             >20 U/l in female patients aged =60 years<br><br>        Exclusion Criteria:<br><br>          -  HbA1c > 8.0<br><br>          -  Creatine kinase (CK) >5 times the upper limit of normal<br><br>          -  Patients having taken lipid lowering medication within 8 weeks of the screening visit<br>
<br>        Inclusion Criteria:<br><br>          -  At screening has suspected or confirmed CDI, and is receiving or is planning to<br>             receive a 10- to 21-day course of antibacterial drug treatment for CDI<br><br>          -  At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects<br>             the presence of C. difficile toxin in stool, and is still receiving antibacterial drug<br>             treatment for CDI.<br><br>          -  Female is not pregnant, and not breastfeeding; but if of childbearing potential agrees<br>             to follow contraceptive guidance during the treatment period and for at least 12 weeks<br>             after the last dose of study treatment<br><br>          -  Participant and/or parent or caregiver must be able to read, understand, and complete<br>             the daily diary<br><br>        Exclusion Criteria:<br><br>          -  Has an uncontrolled chronic diarrheal illness<br><br>          -  Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its<br>             excipients<br><br>          -  At randomization, their planned course of antibacterial drug treatment for CDI is<br>             longer than 21 days<br><br>          -  At screening has received any listed prohibited prior and concomitant treatments and<br>             procedures<br><br>          -  Has previously participated in this study, has previously received bezlotoxumab, has<br>             received an experimental monoclonal antibody against C. difficile toxin B, or has<br>             received a vaccine directed against C. difficile or its toxins.<br><br>          -  Has received an investigational study agent within the previous 30 days, or is<br>             currently participating in or scheduled to participate in any other clinical study<br>             with an investigational agent during the 12-week study period<br>
<br>        Inclusion Criteria:<br><br>          -  Histologically or cytologically proven prostate cancer, locally advanced or<br>             metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and<br>             the patient scheduled to receive androgen deprivation therapy<br><br>          -  Serum testosterone levels = 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured<br>             by any laboratory or on site within the previous 6 months or at study start<br><br>          -  Karnofsky performance index > 70<br><br>          -  Expected survival = 9 months<br><br>        Exclusion Criteria:<br><br>          -  Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone<br>             (GnRH) agonists or antagonists within the last 12 months preceding the study or<br>             concomitant treatment with one or more of these substance(s)<br><br>          -  Any current use or within 6 months prior to treatment start of medications which are<br>             known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole,<br>             aminoglutethimide, oestrogens and progesterone<br><br>          -  Patient at risk of spinal cord compression or ureter obstruction<br><br>          -  Prior hypophysectomy or adrenalectomy<br>
<br>        Inclusion Criteria:<br><br>          -  Have given written informed consent approval<br><br>          -  Women must not be at risk to become pregnant during study participation<br><br>          -  Diagnosis of Rheumatoid Arthritis<br><br>          -  Active Rheumatoid Arthritis<br><br>          -  Current, regular use of Methotrexate, at a stable dose<br><br>          -  Have been on at least 1 biologic tumor necrosis factor-alpha (TNFa) inhibitor therapy<br>             and either failed or were intolerant to treatment<br><br>          -  Other criteria to be reviewed by study doctor<br><br>        Exclusion Criteria:<br><br>          -  Use of excluded medications (reviewed by study doctor)<br><br>          -  Have medical findings which, in the opinion of the study doctor, put patient at an<br>             unacceptable risk for participation in the study<br><br>          -  Have had recent or ongoing infection which, in the opinion of the study doctor put<br>             patient at an unacceptable risk for participation<br><br>          -  Evidence of tuberculosis<br><br>          -  Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as<br>             juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or<br>             psoriatic arthritis.<br><br>          -  Other criteria to be reviewed by study doctor<br>
<br>        Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart<br>        failure due to<br><br>          -  acute myocardial infarction or<br><br>          -  ischemic cardiomyopathy with or without previous myocardial infarction or<br><br>          -  dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease,<br>             history of myocarditis (no active myocardial infection present)<br><br>        Exclusion Criteria:<br><br>          -  none, all patients meeting the inclusion criteria will be eligible.<br>
<br>        Inclusion Criteria:<br><br>          -  Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2<br>             and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with<br>             obesity-related comorbidities).  Obesity-related comorbidities associated with a BMI<br>             of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea<br><br>          -  Stable weight (+/-3 kg) for at least 3 months prior to study start<br><br>        Exclusion Criteria:<br><br>          -  History of diabetes mellitis, major psychiatric disorder, significant cardiovascular<br>             disease, stroke, TIA, neurological disorder, non-febrile seizures<br><br>          -  Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg<br>
<br>        Inclusion Criteria:<br><br>          -  Signing of informed consent,<br><br>          -  Patient with either gender with actual signs or symptoms of congestive heart failure<br>             of any origin with NYHA class no less then III,<br><br>          -  Presence of cardiac cachexia as defined above,<br><br>          -  Duration of symptoms of congestive heart failure of at least 6 months,<br><br>          -  Ejection fraction assessed by echocardiography =30%,<br><br>          -  Nutritional support will be offered solely to patients with their pharmacological<br>             treatment firmly established for at least 30 days.<br><br>        Exclusion Criteria:<br><br>          -  Acute decompensation with clinically evident pulmonary or abdominal congestion,<br><br>          -  Any situation (apart from congestive heart failure) that may affect absorption of<br>             nutrients from the gut,<br><br>          -  Presence of active gastritis or ulcer,<br><br>          -  Presence of cancer,<br><br>          -  Presence of thyreotoxicosis,<br><br>          -  Type I diabetes mellitus,<br><br>          -  Pancreatic insufficiency,<br><br>          -  Treatment with ß-blockers,<br><br>          -  Clinically relevant liver disease with significantly elevated enzymes (ALAT or AspAT<br>             or ALP 4 times above normal according to local norms),<br><br>          -  Body mass index > 25,<br><br>          -  unstable angina pectoris or other acute coronary syndromes within last three months,<br><br>          -  Participation in any other studies,<br><br>          -  Signs of uncooperative attitude,<br><br>          -  Known HIV virus infection,<br>
<br>        Inclusion Criteria:<br><br>          -  systemic or cutaneous lupus erythematosus confirmed by histological analysis<br><br>          -  written informed consent available prior to any study-procedures<br><br>        Exclusion Criteria:<br><br>          -  patients with conditions that are contrary to the above mentioned criteria<br>      ;<br>        Inclusion Criteria:<br><br>          -  systemic or cutaneous lupus erythematosus confirmed by histological analysis<br><br>          -  written informed consent available prior to any study-procedures<br><br>        Exclusion Criteria:<br><br>          -  patients with conditions that are contrary to the above mentioned criteria<br>      ;<br>        Inclusion Criteria:<br><br>          -  systemic or cutaneous lupus erythematosus confirmed by histological analysis<br><br>          -  written informed consent available prior to any study-procedures<br><br>        Exclusion Criteria:<br><br>          -  patients with conditions that are contrary to the above mentioned criteria<br>      ;<br>        Inclusion Criteria:<br><br>          -  systemic or cutaneous lupus erythematosus confirmed by histological analysis<br><br>          -  written informed consent available prior to any study-procedures<br><br>        Exclusion Criteria:<br><br>          -  patients with conditions that are contrary to the above mentioned criteria<br>
<br>        Inclusion Criteria:<br><br>          -  aSAH grade I-IV Hunt und Hess<br><br>          -  bleeding CCT Fisher grade 3-4<br><br>          -  therapy within 48h after aSAH<br><br>          -  preoperative angiography as well as control angiography<br><br>          -  Glasgow Outcome Scale 4 to 5 after therapy<br><br>        Exclusion Criteria:<br><br>          -  known intra-, peri- or suprasellar neoplasia<br><br>          -  preexisting hypopituitarism of any degree<br><br>          -  previous hormonal substitution<br><br>          -  previous radiation<br><br>          -  for the neuropsychological examination: difficulties with German language<br>
<br>        Inclusion Criteria:<br><br>          -  Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing<br>
<br>        All consecutive patients at cluster sites meeting all inclusion criteria undergoing CCTA of<br>        64-detector rows or greater will be included within the CONFIRM registry.<br><br>        Inclusion Criteria:<br><br>          1. Age > 18 years<br><br>          2. Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of<br>             standard of care<br><br>          3. Interpretable CCTA<br><br>          4. Prospective data collection for CAD risk factors.<br><br>        Exclusion Criteria:<br><br>        No explicit patient exclusion criteria are defined.<br>
<br>        Inclusion Criteria:<br><br>          -  Signed informed consent<br><br>          -  Men or women aged 18 to 75 years<br><br>          -  Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by<br>             endoscopy and histology<br><br>        Exclusion Criteria:<br><br>          -  Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,<br>             diverticular disease associated colitis, microscopic colitis (i.e., collagenous<br>             colitis and lymphocytic colitis)<br><br>          -  Toxic megacolon<br><br>          -  Screening stool positive for germs causing bowel disease<br><br>          -  Malabsorption syndromes<br><br>          -  Celiac disease<br><br>          -  Other inflammatory or bleeding disorders of the colon and intestine, or diseases that<br>             may cause diarrhoea or gastrointestinal bleeding<br>
<br>        DISEASE CHARACTERISTICS:<br><br>          -  Diagnosis of T-cell chronic lymphocytic leukemia (T-CLL) or T-cell prolymphocytic<br>             leukemia (T-PLL)<br><br>          -  Previously untreated disease OR patient may have received up to 2 therapies<br><br>        PATIENT CHARACTERISTICS:<br><br>          -  ECOG performance status 0-2<br><br>          -  Life expectancy > 6 months<br><br>          -  No severe organ dysfunction<br><br>          -  No other concurrent or previous neoplasm<br><br>          -  No autoimmune hemolytic anemia or thrombocytopenia<br><br>        PRIOR CONCURRENT THERAPY:<br><br>          -  See Disease Characteristics<br><br>          -  No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab<br>
<br>        Inclusion Criteria:<br><br>          -  Subjects > 18 and < 60 years old.<br><br>          -  Patients with diabetes type 1 should fulfill the following criteria:<br><br>               -  ICT Insulin therapy was necessary within the first 3 months after diagnosis;<br><br>               -  HbA1c-Wert < 7%.<br><br>        Exclusion Criteria:<br><br>          -  Diabetes type 1 or 2 (for the healthy group).<br><br>          -  Biochemical evidence of impaired hepatic or renal function.<br><br>          -  History of cardiovascular disease.<br><br>          -  Uncontrolled hypertension.<br><br>          -  Current inflammatory, malignant or psychiatric disease.<br><br>          -  Pregnancy<br>
<br>        Inclusion Criteria:<br><br>          -  Adult male or female (surgically sterile or post-menopausal or confirmed not to be<br>             pregnant)<br><br>          -  Trauma injury (blunt and/or penetrating) resulting in lactic acidosis due to<br>             hemorrhagic shock  (blood lactate level  = 5 mmol/L; equivalent to = 45 mg/dL)<br><br>          -  Informed consent obtained before any study-related activities<br><br>        Exclusion Criteria:<br><br>          -  Not expected to survive 24 hours after randomization<br><br>          -  Evidence of severe traumatic brain injury as defined by any one of the following:<br>             Known non-survivable head injury or open brain injury; Glasgow Coma Score (GCS) = 3,<br>             4 or 5, or known AIS = 5 if GCS > 5; Immediate open intracranial operation; Abnormal<br>             physical exam indicative of severe CNS or spinal injury<br><br>          -  Significant ongoing uncontrolled hemorrhage where control of bleeding is not expected<br>             within 2 hours of randomization<br><br>          -  Cardiac arrest prior to dosing<br><br>          -  Estimated time from injury to dosing > 4 hours<br><br>          -  Estimated time from hospital admission to randomization > 2 hours<br><br>          -  Known or suspected pregnancy (confirmed by urine test)<br><br>          -  Previous participation in this study<br><br>          -  Professional or ancillary personnel involved with this study<br><br>          -  Receipt of any investigational drug(s) within 30 days prior to study<br>
<br>        Inclusion Criteria:<br><br>          -  Patients having received a renal allograft from a cadaveric or living donor with low<br>             or moderate risk of developing acute rejection episodes.<br><br>        Exclusion Criteria:<br><br>          -  Contraindications according to Summary of the Product Characteristics (SmPC).<br>
<br>        DISEASE CHARACTERISTICS:<br><br>          -  Cytologically and immunophenotypically confirmed diagnosis of B-cell chronic<br>             lymphocytic leukemia (CLL)<br><br>               -  Relapsed or refractory disease<br><br>        PATIENT CHARACTERISTICS:<br><br>          -  No known hypersensitivity to any of the study medications<br><br>          -  No uncontrolled infection<br><br>          -  No impaired organ function<br><br>        PRIOR CONCURRENT THERAPY:<br><br>          -  Not specified<br>
<br>        Inclusion Criteria:<br><br>          -  Untreated metastatic adenocarcinoma of the pancreas<br><br>          -  Adequate hematologic, renal and liver function<br><br>          -  Eastern Cooperative Oncology Group (ECOG) 0 or 1<br><br>        Exclusion Criteria:<br><br>          -  Prior chemotherapy or radiotherapy for pancreatic cancer<br><br>          -  Central nervous system metastases<br><br>          -  External biliary drain<br>
<br>        Inclusion Criteria:<br><br>          -  Male and female cancer patients<br><br>          -  Prior to tyrosine kinase inhibitor therapy (any substance, any line)<br><br>          -  Age: at least 18 yrs<br><br>          -  Body mass index (BMI): at least 18 kg/m2<br><br>          -  ECOG performance status: at most 2<br><br>          -  Must be able to meet the requirements of the study protocol<br><br>        Exclusion Criteria:<br><br>          -  Acute infectious diseases<br><br>          -  No ambulatory ability<br><br>          -  Severe neurological disorders<br><br>          -  Severe cardiovascular diseases<br><br>          -  Severe pulmonary insufficiency<br><br>          -  Severe renal insufficiency<br><br>          -  Other current tumor diseases<br><br>          -  Conditions rendering compliance impossible<br><br>          -  Participation in regular strength training<br>
<br>        Inclusion Criteria:<br><br>          -  Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with<br>             diverting ileostomy.<br><br>        Exclusion Criteria:<br><br>          -  Patients who are pregnant.<br><br>          -  Patients with ongoing abdominal abscess.<br><br>          -  Patients with ongoing bacterial peritonitis.<br>
<br>        Inclusion Criteria:<br><br>          -  Male and female subjects above 50 years of age<br><br>          -  Suffering from joint pain which is due to active rheumatoid arthritis<br><br>          -  Obvious signs of inflammation in at least one joint (e.g. swelling, erythema, or<br>             local elevated temperature)<br><br>          -  Otherwise healthy<br><br>          -  Informed consent<br><br>        Exclusion Criteria:<br><br>          -  Patients 80 years and older<br><br>          -  Clinically significant disease of the cardiovascular system, respiratory system,<br>             hepato-biliary system or central nervous system (CNS)<br><br>          -  Excretory hepatic or renal insufficiency<br><br>          -  Regular intake of any drug, except for hormone replacement therapy in females<br><br>          -  Previous administration of xenogenous proteins<br><br>          -  History of anaphylactic reaction to any drug administered by a parenteral pathway<br><br>          -  Previous participation in a radiopharmaceutical drug trial (unless the effective dose<br>             acquired by participation in the current trial will remain below 10 mSv)<br><br>          -  Participation in any clinical drug trial within 3 months prior to enrolment<br><br>          -  Women of child-bearing potential (child-bearing potential to be ruled out by one of<br>             the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy,<br>             or bilateral tubal ligation)<br><br>          -  Long term medication with strong antiphlogistic agents/pain killers such as<br>             methotrexate, corticoids, or immunosuppressants prior to enrolment<br>
<br>        Inclusion Criteria:<br><br>          -  age > 18 yr<br><br>          -  scheduled for elective rigid bronchoscopy<br><br>        Exclusion Criteria:<br><br>          -  known neuromuscular disease<br><br>          -  significant hepatic or renal dysfunction<br><br>          -  family history of malignant hyperthermia<br><br>          -  known allergy to one of the drugs used in this protocol<br><br>          -  pregnancy or breastfeeding<br>      ;<br>        Inclusion Criteria:<br><br>          -  age > 18 yr<br><br>          -  scheduled for elective rigid bronchoscopy<br><br>        Exclusion Criteria:<br><br>          -  known neuromuscular disease<br><br>          -  significant hepatic or renal dysfunction<br><br>          -  family history of malignant hyperthermia<br><br>          -  known allergy to one of the drugs used in this protocol<br><br>          -  pregnancy or breastfeeding<br>      ;<br>        Inclusion Criteria:<br><br>          -  age > 18 yr<br><br>          -  scheduled for elective rigid bronchoscopy<br><br>        Exclusion Criteria:<br><br>          -  known neuromuscular disease<br><br>          -  significant hepatic or renal dysfunction<br><br>          -  family history of malignant hyperthermia<br><br>          -  known allergy to one of the drugs used in this protocol<br><br>          -  pregnancy or breastfeeding<br>      ;<br>        Inclusion Criteria:<br><br>          -  age > 18 yr<br><br>          -  scheduled for elective rigid bronchoscopy<br><br>        Exclusion Criteria:<br><br>          -  known neuromuscular disease<br><br>          -  significant hepatic or renal dysfunction<br><br>          -  family history of malignant hyperthermia<br><br>          -  known allergy to one of the drugs used in this protocol<br><br>          -  pregnancy or breastfeeding<br>
<br>        Inclusion Criteria:<br><br>          -  age 18-69 years<br><br>          -  BMI =27 kg/m2<br><br>          -  coffee consumption of =3 cups per day<br><br>        Exclusion Criteria:<br><br>          -  new diagnosed type 2 diabetes during the last 6 months<br><br>          -  severe diseases with hospital stay during the last 3 months<br><br>          -  change of body weight of more than 2 kg per week during the last 4 weeks<br><br>          -  smoking cessation during the last 3 months or planned during the study<br><br>          -  acute infects<br><br>          -  chronical diseases with except of type 2 diabetes mellitus<br><br>          -  regular pharmacological therapy with except of oral antidiabetic medication or<br>             contraception<br><br>          -  lack of contraception in women<br><br>          -  breastfeeding<br><br>          -  physical activity of more than 1 hour per day<br>
<br>        Inclusion Criteria:<br><br>          -  Patients must have pain present for more than 3 months after the healing of shingles<br>             skin rash<br><br>          -  Patients at screening must have a score >/=40 mm on the pain visual analogue scale<br><br>        Exclusion Criteria:<br><br>          -  Patients with significant renal and hepatic impairment<br><br>          -  Patients with other severe pain, that may impair the self-assessment of the pain due<br>             to shingles<br><br>          -  Patients with clinically abnormal electrocardiogram<br>
<br>        Inclusion Criteria:<br><br>          -  Have a diagnosis of cluster headache as defined by International Headache Society<br>             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with<br>             a history of episodic cluster headache with at least two cluster periods lasting from<br>             7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1<br>             month.<br><br>          -  Participants are able to distinguish cluster headache attacks from other headaches.<br><br>        Exclusion Criteria:<br><br>          -  Current enrollment in or discontinuation within the last 30 days from, a clinical<br>             trial involving any investigational drug or device.<br><br>          -  Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)<br>             antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).<br><br>          -  Are taking indomethacin and/or are suspected of having another distinct trigeminal<br>             autonomic cephalalgia.<br><br>          -  A history of migraine variants that could implicate or could be confused with<br>             ischemia.<br><br>          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic<br>             proteins.<br><br>          -  A history or presence of other medical illness that indicates a medical problem that<br>             would preclude study participation.<br><br>          -  Evidence of significant active or unstable psychiatric disease, in the opinion of the<br>             investigator.<br><br>          -  Women who are pregnant or nursing.<br>
<br>        Inclusion Criteria:<br><br>          -  Diagnosis of Pseudoxanthoma elastcium based on histopathologic and/or genetic testing<br>
<br>        Inclusion Criteria:<br><br>          -  Patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at<br>             the time of randomization and with at least one ECG-documented AF/AFL episode in the<br>             last 3 months.<br><br>        Exclusion Criteria:<br><br>          -  MAIN CRITERIA (non-exhaustive list, see protocol for details):<br><br>        Women of childbearing potential without adequate birth control, Pregnant women,<br>        Breastfeeding women,  Congestive heart failure NYHA class III or IV, Conditions which<br>        increase the risk of severe antiarrhythmic  drug side effects, Severe associated<br>        conditions.<br>
<br>        Inclusion Criteria:<br><br>          -  Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control<br>             with normal adrenal function and normal glucose regulation<br><br>          -  Age = 18 years<br><br>          -  Ability to comply with the study protocol<br><br>          -  Capability to perform spiroergometry<br><br>        Exclusion Criteria:<br><br>          -  Any contraindication for performing spiroergometry according to the guidelines of the<br>             German Cardiac Society:<br><br>               -  acute myocardial infarction<br><br>               -  instable angina pectoris<br><br>               -  symptomatic arrhythmia<br><br>               -  severe and symptomatic stenosis of the aortic valve<br><br>               -  decompensated heart failure<br><br>               -  acute pulmonary embolism<br><br>               -  Acute myocarditis<br><br>               -  Acute pericarditis<br><br>               -  Acute aortic dissection<br><br>               -  main coronary artery disease<br><br>               -  valvulopathies<br><br>               -  electrolyte disturbance<br><br>               -  arterial hypertension (systolic blood pressure > 200 mm Hg, diastolic BP > 110<br>                  mm Hg)<br><br>               -  Tachyarrhythmia or Bradyarrhythmia<br><br>               -  Hypertrophic cardiomyopathy and other forms of obstructive heart disease<br><br>               -  second or third degree atrioventricular block<br><br>          -  Fever<br><br>          -  Diabetes mellitus Type 2<br><br>          -  Diseases or medication influencing the endogenous levels of plasma catecholamines(e.<br>             g. pheochromocytoma, paraganglioma, antidepressants, levodopa)<br><br>          -  Glucocorticoid-pharmacotherapy<br>
<br>        Inclusion Criteria:<br><br>          -  Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the<br>             two.<br><br>          -  Patient requires replacement of his/her native aortic valve with a bioprosthesis with<br>             or without concomitant procedures.<br><br>          -  Patient is above the minimum age as required by local regulations to be participating<br>             in a clinical study.<br><br>          -  Patient is willing to return to the implant site for follow-up visits.<br><br>          -  Patient has been adequately informed of this clinical study and is willing to sign the<br>             patient Data Release Form.<br><br>        Exclusion Criteria:<br><br>          -  Patient requires replacement of two or more valves.<br><br>          -  Patient who underwent previous aortic valve replacement (AVR).<br><br>          -  Patient with native bicuspid aortic valve.<br><br>          -  Patient with active endocarditis or other systemic infection.<br><br>          -  Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or<br>             ascending aorta geometry as seen via preoperative imaging.<br>
<br>        Inclusion Criteria:<br><br>          -  Body mass index between 22 and 40 kg/m²<br><br>          -  Subjects meeting pre-defined estimated glomerular filtration rate criteria and<br>             creatinine clearance rate<br><br>               -  Normal (=90 mL/min/1.73 m2)<br><br>               -  Mild (60-89 mL/min/1.73 m2)<br><br>               -  Moderate (45-59 mL/min/1.73 m2)<br><br>               -  Moderate (>30-44 mL/min/1.73 m2)<br><br>        Exclusion Criteria:<br><br>          -  History of acute metabolic complications<br><br>          -  Uncontrolled Hypertension<br><br>          -  History of Hypersensitivity to Exenatide<br><br>          -  Cardiovascular Disease<br><br>          -  History of Acute or chronic pancreatitis<br><br>          -  Personal or family history of Multiple endocrine neoplasia type 2<br><br>          -  History of Medullary thyroid cancer<br><br>          -  Severe renal failure, End stage renal disease or dialysis<br>
<br>        Inclusion Criteria:<br><br>        - Patients with acute symptomatic proximal deep vein thrombosis<br><br>        Exclusion Criteria:<br><br>          -  Contraindication to comparator drugs<br><br>          -  Symptomatic Pulmonary embolism<br><br>          -  Conditions with increased bleeding risk<br><br>          -  Unstable patients with reduced life expectancy<br><br>          -  Severe renal impairment<br><br>          -  Impaired liver function<br><br>          -  Strong CYP 3A4 inhibitors<br><br>          -  Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with<br>             anticoagulants or fibrinolytics<br><br>          -  NSAIDs with half-life > 17 hours<br>
<br>        Inclusion Criteria:<br><br>          -  Newly diagnosed patients with de novo or secondary AML<br><br>          -  Intermediate or poor risk<br><br>          -  In first complete remission<br><br>          -  Age 51-70 years<br><br>          -  Fit for the procedure<br><br>          -  Fit for further consolidation chemotherapy<br><br>        Exclusion Criteria:<br><br>          -  Planned for a full-dose allogeneic transplant<br>
<br>        Inclusion Criteria:<br><br>          -  Medical indication: allogeneic stem cell transplantation<br><br>        Exclusion Criteria:<br><br>          -  Orthopeadic limitations that hamper the exercise intervention<br><br>          -  Osseous degenerations that have an improved fracture risk<br>
<br>        Inclusion Criteria:<br><br>          -  • ASA I-III,<br><br>               -  Age 18-85 years,<br><br>               -  Body weight 50-125 kg<br><br>               -  If female, with either a history of an accepted method of anticonception for at<br>                  least 3 month prior and 1 month following the termination of the study or<br>                  climacteric or with a negative betA- HCG-Test in urine or serum.<br><br>               -  Preoperative blood donation of at least 2 units (450mL whole blood)<br><br>               -  Preoperative hemoglobin level > 10 mg/dL<br><br>               -  Able and willing to sign informed consent<br><br>        Exclusion Criteria:<br><br>          -  Subjects with a contraindication for preoperative blood donation (PAD) (in 12, PP<br>             36-43).<br><br>               -  systemic infection<br><br>               -  acute bacterial or viral diseases<br><br>               -  anemia  (Hb > 11g/dL)<br><br>               -  myocardial infarction within the past 6 month,<br><br>               -  instable angina pectoris<br><br>               -  vascular stenosis (i.e. of the coronary or internal carotid arteries)<br><br>               -  hemodynamic relevant valvular stenosis<br><br>               -  heart failure > NYHA II<br><br>               -  history of strokes or TIA<br><br>               -  steroid therapy,<br><br>               -  immune deficiency,<br><br>               -  hematological or endocrinological disease,<br><br>               -  coagulopathy,<br><br>               -  history of organ transplantation,<br><br>               -  simultaneous participation in a second study<br><br>               -  pregnancy<br><br>               -  membership at Jehovah's Witnesses<br><br>               -  intended use of a cell saver<br>
<br>        Inclusion Criteria:<br><br>          -  Healthy men and women<br><br>          -  Aged 20-44 years<br><br>          -  Caucasian origin<br><br>          -  Body mass index (BMI) 19-25 kg/m2<br><br>          -  Used to drinking coffee (similar to study coffee) on a daily basis<br><br>          -  Being able to tolerate a 48-hour coffee abstinence<br><br>          -  Normal oral glucose tolerance test<br><br>          -  Having signed the informed consent form<br><br>        Exclusion Criteria:<br><br>          -  Taking medication or dietary supplements<br><br>          -  Smoking<br><br>          -  Performing a competitive sport<br><br>          -  Having metabolic disorders<br><br>          -  Long gut transit time (>24 h)<br><br>          -  Blood donor<br><br>          -  Irregularity in menstrual cycle (for women)<br><br>          -  Pregnancy (for women)<br><br>          -  Subject who cannot be expected to comply with the study procedures.<br><br>          -  Currently participating or having participated in another clinical trial during the<br>             last 4 weeks prior to the beginning of this study.<br>
<br>        Inclusion Criteria:<br><br>          -  Ambulatory male or female, 18 to 70 years of age<br><br>          -  Body mass index ranging in-between 18 and 30 kg/m²<br><br>          -  Normal blood pressure<br><br>          -  Patients suffering from low back pain<br><br>          -  Low back pain, localized below the costal margin and above the inferior gluteal<br>             folds, either as acute low back pain, or as chronic or intermittent low back pain<br><br>        Exclusion Criteria:<br><br>          -  Hypersensitivity to acetylsalicylic, salicylates, or other Non Steroidal<br>             Anti-inflammatory drugs<br><br>          -  Serious physical illness especially uncontrolled disorders of kidney, liver, lung,<br>             heart or brain function, neurological disorders or severe chronic or terminal disease<br><br>          -  Pregnancy or lactation period<br><br>          -  Abuse of alcohol or addictive substances<br>
<br>        Inclusion Criteria:<br><br>          -  Subjects who first used Protopic® 0.03% or 0.1% before they were sixteen years of age<br>             and were treated for at least 6 weeks for the treatment of Atopic dermatitis may<br>             enroll into the study.<br>
<br>        Inclusion Criteria:<br><br>          -  tumor is located in a previously irradiated area with at least 50 Gy or there is an<br>             overlap of radiation fields with resulting total doses greater than 90 Gy to expect<br><br>          -  tumor size and localization allow high dose re-irradiation (individual decision)<br><br>          -  exclusion of distant metastases<br><br>          -  Time interval between pre-irradiation and re- irradiation at least 1 year for local<br>             recurrence; at least 6 months for secondary tumor disease<br><br>          -  age = 18 years<br><br>          -  previous radiotherapy treatment plans available<br><br>          -  pre-treatment imaging (pre re-irradiation) available<br><br>          -  good general condition (ECOG 0-1)<br><br>          -  dental treatment performed, if necessary<br><br>          -  in case of surgery before re-irradiation: resection status is R-1 or R-2<br><br>          -  clinical suspicion of residual tumor by very scarce surgical margins (<1 mm)<br><br>          -  pathological secured extracapsular extension (ECE)<br><br>          -  indications by an interdisciplinary tumor board<br><br>          -  patient able to understand the intention and procedures of the trial, written informed<br>             consent<br><br>        Exclusion Criteria:<br><br>          -  no description of the R- status after resection of the tumour<br><br>          -  pregnancy<br><br>          -  no written informed consent<br><br>          -  distant metastases<br><br>          -  interval between first and second irradiation < 6 months at secondary tumor or <1 year<br>             when local recurrence of previously irradiated tumor<br><br>          -  simultaneous participation in another intervention study , if further treatment must<br>             be carried out<br>
<br>        Inclusion criteria:<br><br>          -  Recipients of a first or second kidney transplant from a deceased, living unrelated or<br>             non-human leukocyte antigen (HLA) identical living related donor.<br><br>          -  Recipients of a kidney with a cold ischemia time < 30 hours.<br><br>          -  Recipients of a kidney from a donor 10 - 65 years old.<br><br>        Exclusion criteria:<br><br>          -  Multi-organ transplant recipients.<br><br>          -  Recipients of an organ from an non-heart beating donor.<br><br>          -  Patients receiving a second kidney allograft if the first allograft was<br><br>          -  Functional for less than three years<br><br>          -  Patients who are treated with drugs that are strong inducers or inhibitors of<br>             cytochrome P450 3A4 (CYP3A4) at screening and cannot discontinue this treatment.<br><br>        Other protocol-defined inclusion/exclusion criteria may apply<br>
<br>        Inclusion Criteria:<br><br>          -  Indication for ICD implantation either as primary or secondary prevention<br><br>          -  Patient informed consent<br><br>        Exclusion Criteria:<br><br>          -  ICD replacement indication<br><br>          -  Indication for cardiac resynchronisation therapy<br><br>          -  Inability to fully understand psychosomatic questionnaires, especially cognitive<br>             impairment or German language deficits<br><br>          -  Co-morbidities with a resulting life expectancy of less than one year<br><br>          -  Psychosomatic disease (requiring psychiatric therapy)<br><br>          -  Age <18 years<br><br>          -  Patients who are already enrolled in another study<br>
<br>        Inclusion Criteria:<br><br>          -  Patients aged 18 years or older<br><br>          -  Patients with arterial occlusion of one or both lower limbs with acute decompensated<br>             ischemia (Rutherford IIA to III)<br><br>          -  Informed consent of the patient<br><br>        Exclusion Criteria:<br><br>          -  Previous attempt of recanalisation (e.g. lysis therapy)<br><br>          -  Known A. poplitea aneurysm of the affected extremity<br><br>          -  Severe heart failure NYHA IV<br><br>          -  Known atrial thrombus<br><br>          -  Terminal renal insufficiency (creatinine >10mg/dl or current dialysis therapy,<br>             previous transplantation of kidney)<br><br>          -  Hypersensitivity to allopurinol<br><br>          -  Hypersensitivity to one component part of the reperfusion solution<br><br>          -  Participation in a clinical trial during the study or 30 days before<br><br>          -  Pregnancy or lactation<br><br>          -  Patient incapable of contracting or not able to understand the character, meaning and<br>             consequences of the clinical trial<br><br>          -  Abuse to drugs or alcohol<br>
<br>        Inclusion Criteria:<br><br>          -  radicular or myelopathic compression syndrome in the cervical spine<br><br>        Exclusion Criteria:<br><br>          -  neurological diseases with influence on the neuromuscular function<br><br>          -  previous surgery on the cervical spine<br>
<br>        Inclusion Criteria:<br><br>          -  Male or female Patients, =18 to =75 years of age, who have a diagnosis of chronic<br>             plaque psoriasis for at least 6 months<br><br>          -  Non-anorexic subjects with a BMI =20<br><br>          -  Psoriasis Area and Severity Index (PASI) score of =12<br><br>          -  Plaque psoriasis covering =10% of body surface area (BSA)<br><br>          -  Psoriasis severity at least moderate, scoring at least 3 on the 0 to 5 point<br>             Physician Global Assessment (PGA) scale<br><br>        Exclusion Criteria:<br><br>          -  The subject presents with the predominant type of psoriasis as guttate,<br>             erythrodermic, inverse, pustular or palmo-plantar or an unstable form of psoriasis<br><br>          -  The subject has not undergone wash-out periods of sufficient duration for the<br>             following treatments at Baseline: Topical psoriasis treatments; Systemic, oral or<br>             injected, psoriasis treatments; Phototherapy<br><br>          -  The subject anticipates getting enough ultra-violet light during the study to cause<br>             psoriasis to improve<br><br>          -  The subject has a known allergy or sensitivity to the study treatment(s) or to any of<br>             the excipients contained in the study drug formulation<br><br>          -  History of cancer, the exception is skin cancer<br><br>          -  Has a clinically significant systemic infection within 30 days of Day 0, or a history<br>             or presence of recurrent or chronic infection<br><br>          -  Evidence of tuberculosis as indicated by a positive tuberculin skin test or a<br>             quantiferon test in subjects known to have a + PPD and a negative chest x-ray at<br>             screening<br><br>          -  History of clinically significant hypoglycemia<br><br>          -  Subjects with currently active peptic ulcer / gastroesophageal reflux disease<br>
<br>        Inclusion Criteria:<br><br>          -  male or female outpatient, >= 40 years of age<br><br>          -  meets ACR clinical and radiographic criteria for classification of idiopathic<br>             (primary) osteoarthritis of the knee with symptom duration for at least 3 months<br><br>          -  meets ARA functional status requirements<br><br>          -  meets WOMAC pain subscale score requirements<br><br>          -  has taken analgesics for the treatment of their knee OA for at least 4 out of 7 days<br>             in each of the 4 weeks preceding screen<br><br>        Exclusion Criteria:<br><br>          -  any pre-specified clinical/biological/ECG abnormality<br><br>          -  any pre-specified drug sensitivity<br><br>          -  history of peptic ulceration or GI bleeding<br><br>          -  use of protocol-specified medications<br><br>          -  secondary cause of knee OA<br><br>          -  lower extremity surgery within 6 months of screening<br><br>          -  use of analgesics other than allowed per protocol<br><br>          -  use of corticosteroids or hyaluronan outside of allowed window prior to screening<br>
<br>        Inclusion Criteria:<br><br>          -  Patient has advanced solid malignancy that has progressed despite standard therapy, or<br>             for which no effective standard therapy exists<br><br>          -  Tumor of the patient is p53wt<br><br>          -  Evaluable disease as determined by RECIST 1.1<br><br>          -  WHO performance status 0-2<br><br>        Exclusion criteria:<br><br>          -  Prior treatment with CGM097 or other p53/HDM2-interaction inhibitor<br><br>          -  Patient with symptomatic or growing CNS metastatic lesions<br><br>          -  Concurrent other malignancy<br><br>          -  Clinically significant cardiac disease as defined in the protocol<br><br>          -  Diagnosis of acute or chronic pancreatitis<br><br>          -  Concomitant therapy that precludes enrollment, as defined in the protocol<br><br>          -  Women of child-bearing potential, unless they are using highly effective methods of<br>             contraception during dosing and for 2 weeks after study drug discontinuation<br><br>          -  Pregnant or nursing women<br><br>        Other protocol-defined inclusion/exclusion criteria may apply.<br>
<br>        Inclusion Criteria:<br><br>          -  LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI<br><br>          -  conventional therapy according to the ESC guidelines for heart failure<br><br>          -  BMI > 20 and < 35<br><br>        Exclusion Criteria:<br><br>          -  PCI elder then 21 days<br><br>          -  relevant valvular disease<br><br>          -  history of stroke/multivessel disease/thromboembolic event etc.<br><br>          -  DM Type I<br><br>          -  pregancy<br>
<br>        Inclusion Criteria:<br><br>          -  = 18 years of age with written informed consent<br><br>          -  CTO in native coronary artery<br><br>          -  a) Stable angina, or b) myocardial ischaemia in a territory supplied by CTO, and c)<br>             viability in akinetic myocardium (<50% transmural late enhancement on MRI or normal<br>             resting perfusion scan)<br><br>          -  CTO located in segments 1-3 (RCA), 6-7 (LAD), 11-12 (LCx)<br><br>          -  target artery =2.5mm<br><br>        Exclusion Criteria:<br><br>          -  AMI or NSTE-ACS within 1 month<br><br>          -  Significant untreated coronary stenosis in a territory other than CTO<br><br>          -  Patients with MVD and significant non-CTO stenoses where it is deemed unsafe to treat<br>             the non-CTO lesion first (e.g. Significant proximal LAD lesion with chronically<br>             occluded RCA)<br><br>          -  Patient unsuitable for 12 month dual anti-platelet therapy<br><br>          -  Any exclusion criteria for PCI or DES<br><br>          -  Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year<br>             following index procedure<br>
<br>        Inclusion Criteria:<br><br>          -  female patients 18-75 years<br><br>          -  non-smokers<br><br>          -  must be able to give written informed consent<br><br>          -  planned surgical intervention requiring hospitalisation<br><br>          -  not included in another clinical trial<br><br>        Exclusion Criteria:<br><br>          -  emergency intervention<br><br>          -  total intravenous anesthesia (TIVA) with propofol<br><br>          -  disability to give written informed consent<br><br>          -  physical or psychic disorders requiring permanent psycho-social care<br><br>          -  no German language skills<br>
<br>        Inclusion Criteria:<br><br>          -  healthy Subjects<br><br>          -  unobtrusive, neuropsychological screening<br><br>          -  age: 18-35 years<br><br>          -  right handed<br><br>        Exclusion Criteria:<br><br>          -  untreated severe internal or psychiatric diseases<br><br>          -  epilepsy<br><br>          -  other severe neurological diseases eg., previous major stroke, brain tumour<br><br>          -  contraindications to MRI<br>
<br>        Inclusion Criteria:<br><br>          -  Male or female outpatients who are at least 6 years of age and who will not have<br>             reached their 12th birthday<br><br>          -  Diagnosis of ADHD<br><br>          -  Normal intelligence<br><br>        Exclusion Criteria:<br><br>          -  Weigh less than 20 kg or more than 60 kg at study entry<br><br>          -  Other relevant psychiatric diagnoses<br><br>          -  Are at serious suicidal risk as determined by the investigator<br><br>          -  Have a history of severe allergies<br><br>          -  Alcohol or drug abuse within the past 3 months<br>
<br>        Inclusion Criteria:<br><br>          -  Active smoking (at least 10 cigarettes per day)<br><br>          -  Age > 18 years<br><br>        Exclusion Criteria:<br><br>          -  Any chronic diseases<br><br>          -  Any regular medication<br><br>          -  Any signs or symptoms of an acute infection<br>
<br>        Inclusion Criteria:<br><br>          1. Male or Female age 18 years or older<br><br>          2. Femoral access vessels should be adequate to fit the selected delivery system<br><br>          3. Proximal neck length = 10mm<br><br>          4. Aortic neck diameters = 17mm and = 31mm<br><br>          5. Aortic neck suitable for suprarenal fixation<br><br>          6. Infrarenal and suprarenal neck angulation = 60°<br><br>          7. Iliac fixation length = 15mm<br><br>          8. Iliac diameters = 7mm and = 22mm<br><br>          9. Minimum overall AAA treatment length (proximal landing location to distal landing<br>             location) = 128mm<br><br>         10. Morphology suitable for aneurysm repair<br><br>         11. Provide written informed consent and as applicable written confidentiality<br>             authorization prior to initiation of study procedures<br><br>         12. Subject is willing to comply with the specified follow-up evaluation schedule<br><br>        Exclusion Criteria:<br><br>          1. Subject has one of the following:<br><br>               1. Aneurysm sac rupture or leaking abdominal aortic aneurysm<br><br>               2. Mycotic, dissecting, or inflammatory abdominal aortic aneurysm<br><br>          2. Known allergy or intolerance to nickel titanium (nitinol), Polyethylene terephthalate<br>             (PET), or polytetrafluoroethylene (PTFE)<br><br>          3. Known contraindication to undergoing angiography or anticoagulation<br><br>          4. Existing AAA surgical graft and/or a AAA stent-graft system<br><br>          5. Women of child bearing potential whom are pregnant, lactating, or planning to become<br>             pregnant during the course of the trial<br>
<br>        Inclusion Criteria:<br><br>          -  Female adult patients, >/= 18 years of age<br><br>          -  HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)<br>             relapsing after completed adjuvant Herceptin therapy<br><br>          -  Indication for first-line treatment with Perjeta in combination with Herceptin and<br>             chemotherapy according to the Summary of Product Characteristics<br><br>          -  Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a<br>             potentially curable setting); additional upfront neoadjuvant Herceptin therapy is<br>             allowed<br><br>          -  No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally<br>             recurrent, inoperable) HER2-positive breast cancer<br><br>        Exclusion Criteria:<br><br>          -  Pregnant or breastfeeding women<br><br>          -  Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the<br>             Summary of Product Characteristics<br><br>          -  No Herceptin treatment for early breast cancer in the adjuvant setting<br>
<br>        Inclusion Criteria:<br><br>          -  Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at<br>             least 1 year<br><br>          -  Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)<br><br>        Exclusion Criteria:<br><br>          -  Receiving any oral or injectable medication intended for the treatment of diabetes<br>             mellitus other than insulins in the 12 months prior to screening<br><br>          -  More than one episode of severe hypoglycaemia in the last 6 months<br><br>          -  Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or<br>             gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease,<br>             uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency<br><br>          -  Have obvious clinical signs or symptoms of liver disease<br><br>          -  Have a history of renal impairment<br>
<br>        Inclusion Criteria:<br><br>        Female patients for who the treating physician decides that treatment with long acting FSH<br>        150µg in a GnRH-antagonist protocol is indicated.<br><br>        Exclusion Criteria:<br><br>        Contraindications for the use of gonadotropins (e.g., tumors, pregnancy/lactation,<br>        undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) Use of hormonal<br>        preparations within one month prior to inclusion<br>
<br>        Inclusion Criteria:<br><br>          -  type-2 diabetes<br><br>          -  coronary artery disease<br><br>        Exclusion Criteria:<br><br>          -  age >80 years<br><br>          -  acute coronary syndrome<br><br>          -  life expectancy <1 year<br><br>          -  unable to give informed consent<br>
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<br>Group 2 (chronic tonsillitis): adult patients with 3 or more episodes of recurrent acute tonsillitis per year that are scheduled for routine tonsillectomy<br>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
Inclusion criteria: All patients being diagnosed with Gastrointestinal Stromal Tumors and undergoing systemic target treatment will be included.
Inclusion criteria: Severe aortic stenosis and positive heartteam vote for TAVR
<br>        Inclusion Criteria:<br><br>          -  Typical chest pain (with or without ECG-changes, but no ST-elevation)suggestive of<br>             unstable angina or non-ST-elevated myocardial infarction (NSTEMI)<br><br>          -  Troponin negative at admission according to the current clinical practice Patient<br>             willing and able to give written informed consent<br><br>        Exclusion Criteria:<br><br>          -  Patients with ST-elevation myocardial infarction (STEMI)<br><br>          -  Continuing chest pain or recurrent episodes of chest pain under therapy<br><br>          -  High-risk patients with suspected ACS who need to be hospitalized for reasons<br>             independent of their initial troponin result<br><br>          -  Patients who need to be hospitalized for other medical reasons<br><br>          -  Patients in need of urgent life-saving interventions<br><br>          -  Patients under 18 years of age<br><br>          -  Patients with a life expectancy < 6 months<br><br>          -  Patients with any condition that leads the treating physician to not consider the<br>             patient eligible for the trial<br>
Inclusion criteria: none
Inclusion criteria: Care-dependent people with a dignosed dementia, living in a nursing home
Inclusion criteria: History of arterial hypertension or healthy volunteers
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
Inclusion criteria: - patients with calcifying tendinitis which has proven refractory to conservative treatment and who are treated with shoulder arthroscopy in our clinic<br>- minimum age 18 years<br>- no maximum age
Inclusion criteria: 1. Histopathologically documented CTCL stage = Ib and grading by EORTC (Appendix K)<br>Staging, EORTC classification<br>2. Pretreatment with PUVA if a continuation of the PUVA is no longer possible or with inadequate response<br>3. Karnofsky performance status> 60%<br>4. Age = 18 years<br>5. Adequate organ function (blood count, liver, kidney, cardiac function, electrolytes, lipids)<br>6. Neg. Pregnancy test, efficient contraception in male and female patients (bexarotene could lead to decreased efficacy of hormonal contraceptives)<br>7. No other active malignancy<br>8. No topical chemotherapy, photopheresis or interferon treatment to 28 days prior to study entry<br>9. No topical treatment (steroids, tar-bath), superficial radiotherapy, treatment with other retinoids or beta-carotene two weeks ago baseline *<br>10. No serious systemic disease or infection at study entry<br>11. No participation in another study in the last 14 days prior to study entry<br>12. No pre-treatment with Targretin<br>13. Lack of psychological, familial, sociological or geographical obstacles that hinder the study protocol or the follow-up control<br>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)<br>15. A signed consent of the patient<br>*Continuous topical steroid applications before and during treatment withTargretin
Inclusion criteria: The study will include patients who <br>are receiving a fixed partial denture or telescopic crowns, are at least 18 years old, have given informed consent
Inclusion criteria: Inclusion criteria was a minimum age of 18 years and a written consent after a detailed explanation of the investigation,<br>Cancer pain
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
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
Inclusion criteria: Students attending one of the orthodontic courses of the WWU in the summer semester 2017
Inclusion criteria: Intervention or surgery during hospitalisation
Inclusion criteria: Hospitals with intensive care unit (participants of the trial are hospitals, not patients!)
Inclusion criteria: Patients aged 18 years and older<br>- - - Diabetes mellitus type 2 (insulin-dependent diabetes mellitus (IDDM) and noninsulin-dependent diabetes mellitus (NIDDM))<br>- - - Clinical significant diabetic macular edema (diffuse or focal)<br>- - - Visual acuity (decimal) reduced by diabetic macular edema to = 0,3 and = 0,05 (LogMar = 1,3 and = 0,5) stated by EDTRS charts.<br>- - - Signed informed consent
Inclusion criteria: non-elective admitted patients, who are less than 18 years of age at the time of admission
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)<br>• Pure alcohol dependence<br>• No known contraindications<br>• Written informed consent of the patient to the prospective collection, distribution, analysis of the data and for publication of the results.
Inclusion criteria: Inclusion criteria for patients with myocardial infarction:<br>first event (STEMI or NSTEMI), percutanous coronary intervention; no valvular defect<br><br>Inclusion criteria for patients with stroke:<br>first stroke ever;<br>all transient ischemic attacks (not only first events)
<br>        Inclusion Criteria:<br><br>          -  Clinically, histologically, immunohistochemically and genetically defined muscular<br>             dystrophy with dysferlin-deficiency (LGMD2B/MM).<br><br>          -  Patients should fulfill clinical, morphological, immunohistochemical and immunoblot<br>             criteria of LGMD 2B and definite mutation in dysferlin gene.<br><br>          -  There is no limitation on age for study inclusion.<br><br>        Exclusion Criteria:<br><br>          -  Patients confined to bed or wheelchair.<br><br>          -  Patients with other neurologic or internistic diseases and patients with former or<br>             current steroid treatment will not be included.<br><br>          -  Exclusion criteria during the trial are withdrawal of informed consent or lack of<br>             compliance.<br>
Inclusion criteria: ARDS (acute)<br>Consent to  study given<br>Lung CT scan performed before study recruitment
Inclusion criteria: postmenopausal women under the age of 75 years; mean BMI of 25 kg/m2; non-smoker; study participants who gave written consent
Inclusion criteria: Patients age >18 and < 55 years<br>Patients suffering from persistent subjective or objective  patellofemoral instability after Patellaluxation <br>Patients undergoing operative Treatment for patella stabilization
Inclusion criteria: German-speaking, age between 18 and 65, member of the rehabilitation team
Inclusion criteria: 1. Patients who have given their signed declaration of consent and data<br>protection declaration<br>2. Males and females aged = 18 years<br>3. Patients scheduled for transurethral resection of the bladder of a suspected bladder<br>cancer based on recent findings in cystoscpy that have to be diagnosed at the respective study site prior to Visit 1<br>4. Patients including multiple baldder tumours or suspicious lesions<br>5. Patients with initial and/or recurrent bladder cancer<br>6. Patients with adequate renal and hepatic function according to the<br>investigator<br>7. No known anaesthetic risks (risk of narcosis ASA 1-3)<br>8. All women of child-bearing potential must have a negative serum or<br>urine pregnancy test at screening and must use hormonal contraception<br>or intrauterine device (IUD) during the treatment and for at least one<br>month thereafter.
Inclusion criteria: every Patient with age below 12 years requiring general anesthesia
Inclusion criteria: Multiple Sclerosis patients starting therapy with alemtuzumab
Inclusion criteria: - First ever stroke within last 3 months<br>- Stroke patients who are not able to walk alone
Inclusion criteria: Healthy individuals
Inclusion criteria: Postlingual onset of profound sensorineural hearing loss , no congenital hearing loss ; Hearing loss in opposite ear least PTA = 50 dB<br>• Freedom or CI500 series implant (Cochlear)<br>• use the speech processor CP910 with a minimum of 6 months experience <br>• 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%<br>• Preferably unilateral CI patients ; in bilateral CI patients fitting should be bilateral.<br>• language skills : German mother tongue
Inclusion criteria: lung healthy
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.
Inclusion criteria: Degree of dementia: CDR memory value   9; subjective cognitive impairment, MCI, mild to moderate Alzheimer's disease (ICD<br>10, NINCDS/ ADRDA criteria)
<br>        Inclusion Criteria:<br><br>          -  Age > 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest<br>             pain, abnormal stress testing, abnormal noninvasive testing)<br><br>          -  Patients witch semi recent (>3 days) acute coronary syndromes can be included but only<br>             for the non-culprit vessels and outside of primary intervention during acute<br>             myocardial infarction.<br><br>          -  Willing to participate and able to understand, read and sign the informed consent<br>             document before the planned procedure<br><br>          -  Eligible for coronary angiography and/or percutaneous coronary intervention<br><br>          -  Coronary artery disease with at least 1 or more visually assessed de novo coronary<br>             stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches<br>             by coronary angiogram.<br><br>        Exclusion criteria:<br><br>          -  Contraindication to adenosine administration<br><br>          -  Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel<br>
Inclusion criteria: Skin Tumor in need of excision and skin transplantation
Inclusion criteria: chronic critically ill;<br>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
<br>        Inclusion Criteria:<br><br>          -  patients with metastasized renal cell carcinoma treated at the Department of Urology<br>             (University of Munich - Grosshadern Campus)<br><br>               1. with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib<br>                  (Nexavar®) as first-line therapy<br><br>               2. with Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as<br>                  second-line therapy after failed first-line therapy, who are off therapy for at<br>                  least 2 weeks<br><br>          -  no contraindications against contrast-enhanced CT<br><br>          -  obtained informed consent to participate in the study<br><br>        Exclusion Criteria:<br><br>        Patients who have:<br><br>          -  not given informed consent<br><br>          -  known iodine allergy<br><br>          -  high grade renal insuffiency (eGFR < 30ml/min) not on dialysis<br><br>          -  overt hyperthyreoidism<br><br>          -  singular metastases <1cm in diameter<br><br>          -  an increase of their baseline creatine levels of >20% between CT examinations<br>
Inclusion criteria: self-reported weakness of the legs
Inclusion criteria: staff of an institution for disabled persons that consults our psychosomatic consultation in the workplace that we established with this institution
<br>        Inclusion Criteria:<br><br>          -  Patients who have had pretreatment with single or tandem high dose melphalan therapy<br>             and autologous stem cell transplantation as first line therapy<br><br>          -  at least stable disease after stem cell transplantation<br><br>          -  adequate hematological, hepatic and renal lab parameters<br><br>          -  karnofsky status of 70 or more<br><br>        Exclusion Criteria:<br><br>          -  non-secretory multiple myeloma<br><br>          -  previous treatment with bortezomib<br><br>          -  allogenic stem cell transplantation<br><br>          -  other co-existing malignancy beside basaliome<br><br>          -  peripheral neuropathy<br><br>          -  epilepsia<br><br>          -  other severe comorbidities (renal, hepatic, cardiovascular, metabolic, infectious<br>             etc.)<br><br>          -  history of allergic reactions to bortezomib or mannitol<br><br>          -  expected life expectancy of less than 3 months<br>
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)
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
<br>        Inclusion Criteria:<br><br>          -  Females less than or equal to 10 years of age (prior to 11th birthday)<br><br>          -  Diagnosis of McCune-Albright syndrome (MAS)<br><br>          -  Progressive precocious puberty (PPP) associated with MAS<br><br>        Exclusion Criteria:<br><br>          -  Received any prior treatment for PPP associated with MAS with fulvestrant<br><br>          -  Abnormal platelet count or liver function tests<br><br>          -  Bleeding disorders<br><br>          -  Long term anticoagulation therapy<br><br>          -  Known hypersensitivity to any component of the study drug<br>
<br>        Inclusion Criteria:<br><br>          -  Males/females with CDAD<br><br>          -  Females must use adequate contraception<br><br>          -  Signed informed consent<br><br>        Exclusion Criteria:<br><br>          -  Life-threatening CDAD<br><br>          -  Toxic megacolon<br><br>          -  Pregnant<br><br>          -  Concurrent use of diarrheal agents<br><br>          -  Participation in other trials<br>      ;<br>        Inclusion Criteria:<br><br>          -  Males/females with CDAD<br><br>          -  Females must use adequate contraception<br><br>          -  Signed informed consent<br><br>        Exclusion Criteria:<br><br>          -  Life-threatening CDAD<br><br>          -  Toxic megacolon<br><br>          -  Pregnant<br><br>          -  Concurrent use of diarrheal agents<br><br>          -  Participation in other trials<br>      ;<br>        Inclusion Criteria:<br><br>          -  Males/females with CDAD<br><br>          -  Females must use adequate contraception<br><br>          -  Signed informed consent<br><br>        Exclusion Criteria:<br><br>          -  Life-threatening CDAD<br><br>          -  Toxic megacolon<br><br>          -  Pregnant<br><br>          -  Concurrent use of diarrheal agents<br><br>          -  Participation in other trials<br>      ;<br>        Inclusion Criteria:<br><br>          -  Males/females with CDAD<br><br>          -  Females must use adequate contraception<br><br>          -  Signed informed consent<br><br>        Exclusion Criteria:<br><br>          -  Life-threatening CDAD<br><br>          -  Toxic megacolon<br><br>          -  Pregnant<br><br>          -  Concurrent use of diarrheal agents<br><br>          -  Participation in other trials<br>
<br>        Inclusion Criteria:<br><br>          -  males or females, 1-12 years of age;<br><br>          -  candidate for seasonal prophylaxis;<br><br>          -  negative rapid diagnostic test for influenza at baseline.<br><br>        Exclusion Criteria:<br><br>          -  symptoms suggestive of influenza-like illness;<br><br>          -  positive rapid diagnostic test for influenza;<br><br>          -  antiviral treatment for influenza in 2 weeks prior to randomization.<br>
Inclusion criteria: 1. Histologically confirmed metastatic colorectal cancer<br>2. KRAS-wildtype status of the tumour<br>3. No history of therapy with an EGFR targeting agent<br>4. No history of previous chemotherapy for advanced disease<br>5. Measurable tumour lesion with a diameter no smaller than 1.0 cm detected by computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound<br>6. For contrast-enhanced ultrasound: metastases no smaller than 2.0 cm detected by ultrasound<br>7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 or Karnofsky performance scale minimum 60%<br>8. Life expectancy greater than 12 weeks<br>9. Age greater than or equal to 18 years, either sex<br>10. Adequate haematologic, renal and hepatic function<br>11. Ability of the patient to understand the character and individual consequences of this clinical trial<br>12. Written informed consent (must be available before enrolment in the trial)<br>13. For women and men with childbearing potential adequate double barrier contraception, for women: negative pregnancy test<br>14. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Inclusion criteria: <br>- Age 40 – 80 years<br>- TIA or first ischemic stroke<br>- NIHSS < 5<br>- Serumcholesterol > 5 mmol/l, Serum-LDL-C > 3 mmol/l<br>- Written informed consent<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>
<br>        Inclusion Criteria:<br><br>          -  Cytogenetic diagnosis of chronic phase Ph+ CML diagnosed less than 6 months.<br><br>          -  Diagnosis of CML chronic phase confirmed.<br><br>          -  Adequate hepatic and renal function.<br><br>          -  Able to take oral tablets.<br><br>        Exclusion Criteria:<br><br>          -  Exclusions include Philadelphia negative CML.<br><br>          -  Prior anti-leukemia treatment.<br><br>          -  Prior stem cell transplant.<br>
Inclusion criteria: <br>                1. Patients suitable for adjuvant radiotherapy* for cancer of the breast (invasive or in situ) including breast patients receiving neo-adjuvant chemotherapy<br>                2. Patients suitable for radical radiotherapy or brachytherapy for prostate cancer; including post-prostatectomy patients<br>                3. Patients suitable for radical radiotherapy, sequential or concurrent chemoradiotherapy or stereotactic body radiation therapy for lung cancer<br>                4. No other malignancy prior to treatment for the specified tumour types except basal cell or squamous cell carcinoma of the skin<br>                5. No evidence of distant metastases<br>                6. Patients able to provide a venous blood sample<br>                7. Willingness and ability to comply with scheduled visits, treatment plans and available for follow-up within country of origin<br>                8. Greater than 18 years of age; no upper age limit<br>                9. The capacity to understand the patient information sheet and the ability to provide written informed consent<br><br>                *Breast patients receiving chemotherapy should have completed their course of chemotherapy (anthracyclines) at least one month prior to radiotherapy commencing.<br>
Inclusion criteria: 1. Pregnant women aged 18 and older<br>2. Fetuses with a gestational age = 32 weeks<br>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
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 <br>2. Rejection of implant treatment by the patient <br>3. Patients with general health according to American Society of Anesthesiologists (ASA) classification group one ore two <br>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 <br>5. Caries free adjacent teeth <br>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
<br>        Inclusion:<br><br>          -  healthy children between 11-14 months old who received primary vaccination with<br>             Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.<br><br>        Exclusion:<br><br>          -  children having received or planning to receive any investigational products,<br>             vaccines not foreseen in the protocol and immune modifying drugs;<br><br>          -  children having received any additional pneumococcal vaccine than in the primary<br>             study;<br><br>          -  children with any disease that affect the immune system and history of seizures<br>             and/or allergic disease.<br>      ;<br>        Inclusion:<br><br>          -  healthy children between 11-14 months old who received primary vaccination with<br>             Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.<br><br>        Exclusion:<br><br>          -  children having received or planning to receive any investigational products,<br>             vaccines not foreseen in the protocol and immune modifying drugs;<br><br>          -  children having received any additional pneumococcal vaccine than in the primary<br>             study;<br><br>          -  children with any disease that affect the immune system and history of seizures<br>             and/or allergic disease.<br>
Inclusion criteria: 1. Histologically confirmed Hodgkin's disease<br>2. Stages IA (not lympocyte predominant HD), IB, IIA, and IIB without the following risk factors:<br>2.1. Massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter<br>2.2. Extranodal involvement<br>2.3. High Erythrocyte Sedimentation Rate (ESR) (greater than or equal to 50 mm; greater than or equal to 30 mm with B symptoms)<br>2.4. Three or more involved lymph node areas<br>3. No prior therapy for Hodgkin's disease<br>4. Aged 18 - 75 years<br>5. No major organ dysfunction<br>6. Life expectancy more than three months<br>7. Written informed consent
<br>        Inclusion Criteria:<br><br>          -  Group 1: NS, Group 2: NF1 (both genetically assured)<br><br>          -  Age >18 years<br><br>          -  Signed informed consent.<br><br>          -  Persons who are capable to give their consent and understand the aim and rationale of<br>             the study. In case of doubts, an independent medical practitioner will evaluate the<br>             capacity to consent.<br><br>          -  Male participants and female participants who are not capable of bearing children or<br>             who use a method of contraception that is medically approved by the health authority<br>             of the respective country.<br><br>        Exclusion Criteria:<br><br>          -  Epilepsy<br><br>          -  Medication with known CNS effects<br><br>          -  Severe mental retardation<br><br>          -  Side effects during previous medication with and contraindications to LTG and/or LOV<br>             and/or TMS<br><br>          -  Psychiatric diseases<br><br>          -  Previous history of allergic reactions with LTG and LOV medications<br><br>          -  Potentially unreliable patients<br><br>          -  Patients who are not suitable for the study in the opinion of the investigator<br><br>          -  Pregnancy (incl. positive urine pregnancy test)<br><br>          -  Persons who are incapable of giving consent or do not understand the aim or rationale<br>             of the study.<br>
Inclusion criteria: <br>1. Histologically proven triple-receptor-negative metastatic or relapsed breast cancer <br><br>2. Minimum interval after the end of any previous taxane-containing chemotherapy regimen. <br><br>3.  At least one tumor lesion measurable according to RECIST criteria <br><br>4.  Gender: female<br><br>5.  Age greater or equal to 18 years old<br><br>6.  Negative pregnancy test (females of childbearing potential)<br><br>7.  Willingness to perform double-barrier-contraception during study and for 6    months post chemotherapy treatment<br><br>8.   ECOG performance status 0, 1 or 2<br><br>9. Signed informed consent<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>
Inclusion criteria: <br>                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)<br>                2. White European parentage<br>                3. Aged 18 to 65 years<br>                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<br>                5. Individuals aged over 65 can be included if they are medically fit and not taking regular medication other than antidepressants<br>
<br>        Inclusion Criteria:<br><br>          -  Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1<br>             to 9 months before the screening visit.<br><br>        Exclusion Criteria:<br><br>          -  Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection<br><br>          -  Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve<br>             disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute<br>             coronary event or angioplasty or any other major surgery within 1 month, any major<br>             surgery during the planned study period<br><br>          -  History of life-threatening ventricular arrhythmia within 3 months.<br><br>          -  History of Torsades de Pointes (TdP) or family history of long QT-syndrome<br><br>          -  Heart rate (HR) < 50 or > 100 bpm.<br><br>          -  Systolic blood pressure (SBP) < 100 mmHg or > 180 mmHg, or diastolic blood pressure<br>             (DBP) > 100 mmHg.<br><br>          -  Ventricular tachycardia.<br><br>          -  Episode of atrial fibrillation or atrial flutter lasting > 60 seconds.<br><br>          -  Second or third degree atrioventricular (AV) block.<br><br>          -  Potassium (K) < 3.7 mmol/l or > 5.5 mmol/l.<br><br>          -  Creatinine > 170 µmol/l or on dialysis.<br><br>          -  Blood haemoglobin <10 g/dl; clinically significant hepatic impairment.<br>
<br>        Inclusion Criteria:<br><br>          -  Men and women, aged =18 to =75<br><br>          -  Body mass index (BMI) = 40 kg/m2<br><br>          -  Primary hypercholesterolemia on a stable daily dose of a statin for = 6 weeks<br><br>          -  Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L)<br><br>        Exclusion Criteria:<br><br>          -  Any significant acute medical illness, significant cardiovascular history<br><br>          -  Current or history of hepatic or hepatobiliary disease<br><br>          -  Evidence of organ dysfunction or any clinically significant deviation from normal in<br>             physical examination, vital signs, ECG or clinical laboratory determinations beyond<br>             what is consistent with the target population<br>
Inclusion criteria: For entry to the run-in phase:<br>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)<br>2. Agreement between investigator and patient to commence/continue treatment to<br>prevent relapse<br>3. It is considered clinically reasonable to try combination treatment with lithium and valproate semisodium<br><br>For randomisation:<br>1. Uncertainty about which trial treatment would be best for the participant<br>2. Lithium plasma level 0.4 to 1.0 mmol/litre on stable dose of lithium<br>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<br>4. The participant can tolerate the combination of lithium and valproate semisodium<br>5. Adherence during the run-in phase is judged satisfactory by the investigator
Inclusion criteria: <br>                •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)<br><br>                •Newly diagnosed, previously untreated diffuse intrinsic pontine glioma of all tumour grades or without histology when confirmed by central neuroradiological review<br><br>                •Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuropathological review and neuroradiological review<br><br>                •Patient aged 3 years and older but under 18 years at time of diagnosis<br><br>                •Written informed consent of the patient and/or the patient’s parents or legal guardian according to national laws<br><br>                Are the trial subjects under 18? yes<br>                Number of subjects for this age range: 456<br>                F.1.2 Adults (18-64 years) no<br>                F.1.2.1 Number of subjects for this age range<br>                F.1.3 Elderly (>=65 years) no<br>                F.1.3.1 Number of subjects for this age range<br>
Inclusion criteria: 1. Stable patients with renal end stage disease being on hemodialysis for at least six months<br>2. Residual urine volume less than 200 ml per day<br>3. Ages betweeen 18 and 75 years<br>4. Body dry weight between 60 and 80 kg<br>5. Written consent<br>6. Well functioning vascular access
Inclusion criteria: 1. Aged greater than or equal to 60 years, either sex<br>2. Written informed consent of the patient<br>3. Anamnestically two or more years post-menopausal or surgically sterile<br>4. Patients with dislocated femoral neck fracture which is not older than 24 hours and will be operated within the next 24 hours
Inclusion criteria: <br>                1. Primary care dentists and their male and female patient population of all ages in Mecklenburg-Western Pomerania (Germany).<br>                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).<br>
Inclusion criteria: <br>· Male or female patients with at least 18 years of age<br>· Recurrent HSV-1 episodes, at least 2 episodes of typical lesions in the last year<br>· Acute HSV-1 episode <br>· Healthy immune response <br>· History of at least 50% of herpes labialis episodes producing classical” lesion<br>· 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.<br>· Be able to communicate with the investigator and compliant<br>· 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.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>
Inclusion criteria: Both male and female dementia patients aged 60 or older who live in a nursing home
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<br>2. Diabetes controlled by diet, oral antidiabetics or insulin therapy<br>3. Positive for glutamic acid decarboxylase (GAD) autoantibodies<br>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
<br>        Inclusion Criteria:<br><br>          -  Patients with heart failure (NYHA II-IV)<br><br>               1. with optimal medical therapy<br><br>               2. caused by ischemic or non-ischemic cardiomyopathy<br><br>          -  EECP-Therapy and Treatment in the Cardio Centrum Berlin or Charité - University<br>             Medicine Berlin<br><br>          -  Aged 18 to 100 years<br><br>          -  Offered patient information and written informed consent<br><br>        Exclusion Criteria:<br><br>          -  Participation in another interventional trial<br><br>          -  Acute coronary syndrome < 4 weeks prior to enrollment<br><br>          -  Operation < 4 weeks prior to enrollment<br><br>          -  Stroke < 4 weeks prior to enrollment<br><br>          -  Clinically significant disease with hospitalization<br><br>          -  Aortic valvular heart disease = moderate<br><br>          -  Aortic aneurysm<br><br>          -  clinically relevant severe cardiopulmonal diseases<br><br>          -  Resting RR > 160/90mmHg<br><br>          -  Thrombose, Thrombophlebitis < 8 weeks prior to enrollment<br><br>          -  Peripheral artery occlusive disease = Stadium II<br><br>          -  Acute Heart failure<br><br>          -  Pathological bleeding tendency<br><br>          -  Arrhythmias, which interfere with Triggering of the EECP<br><br>          -  Other diseases, that inhibit EECP-Treatment (e.g. Spinal disc herniation)<br><br>          -  Accommodation in an institution due to an official or judicial order<br><br>          -  Women: pregnancy or lactation<br>
<br>        Inclusion Criteria:<br><br>          1. Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.<br><br>          2. Stage IV disease diagnosed within 6 weeks of randomization<br><br>          3. Adequate hematologic function:<br><br>               -  Absolute neutrophil count (ANC) =1.5 x 109/L<br><br>               -  Platelet count =100 x 109/L<br><br>               -  Hemoglobin =9 g/dL<br><br>          4. Adequate hepatic and renal function defined as:<br><br>               -  AST and/or ALT =5.0 x upper limit of normal (ULN) if liver metastases, or =3 x<br>                  ULN without liver metastases<br><br>               -  Alkaline phosphatase <3.0 x ULN or =5.0 x ULN if liver or bone metastases present<br><br>               -  Bilirubin =1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of<br>                  non-hepatic origin, such as hemolysis)<br><br>               -  Estimated Creatinine Clearance =30 mL/min<br><br>          5. PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN<br><br>          6. KPS =70.<br><br>          7. Eastern Cooperative Oncology Group (ECOG) 0-1<br><br>        Exclusion Criteria:<br><br>          1. Prior therapies: BTK inhibitor, radiotherapy, radiotherapy in the adjuvant setting, or<br>             cytotoxic chemotherapy for primary disease of pancreatic adenocarcinoma.<br><br>          2. Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma<br><br>          3. Known brain or leptomeningeal disease (CT or MRI scan of the brain required only in<br>             case of clinical suspicion of central nervous system involvement).<br><br>          4. Major surgery within 4 weeks of first dose of study drug.<br><br>          5. History of stroke or intracranial hemorrhage within 6 months prior to enrollment.<br><br>          6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor.<br>
Inclusion criteria: Patients with HER-2 negative, invasive unilateral breast cancer with known hormone receptor status and tumour grade. ECOG status 0 or 1.<br>Clinical stage should be either<br>- T2, T3, T4 disease, triple negative<br>- T2, T3, T4 disease, ER or PgR positive and moderately differentiated or poorly differentiated tumour grade (G II-III).<br>Paraffin-embedded tumour block should be available for central confirmation of eligiblity criteria. <br>Written consent
Inclusion criteria: ? Histologically- or cytologically-confirmed nonsquamous (adenocarcinoma/large cell or other) NSCLC <br/ ><br>? Advanced (Stage IIIB or Stage IV) disease at the time of study entry <br/ ><br>? 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 <br/ ><br>? Tumor tissue available for analysis of EGFR gene copy number and EGFR mutation status (minimum of eight slides, formalin-fixed, paraffin-embedded tissue). <br/ ><br> <br/ ><br>
<br>        Inclusion Criteria<br><br>        Patients may be eligible for this study if they:<br><br>          -  Are HIV infected.<br><br>          -  Are at least 16 years of age.<br><br>          -  Have an HIV-1 RNA of at least 5,000 copies/ml.<br><br>          -  Have received anti-HIV drugs for at least 3 months and/or have written records of<br>             resistance to at least 1 member of each of the 3 classes of anti-HIV drugs<br>             (nucleoside reverse transcriptase inhibitors [NRTIs], nonnucleoside reverse<br>             transcriptase inhibitors [NNRTIs], and protease inhibitors [PIs]). Resistance to<br>             NNRTIs may not be required in certain cases.<br>
Inclusion criteria: 1. Healthy male and female newborns aged 4 weeks<br>2. Regularly developed newborns - body weight:  = 2500 g; gestational age  > 37+0 weeks<br>3. No relevant illnesses since the birth (except transient Hyperbilirubinemia)<br>4. Positive atopic anamnesis with at least one parent (atopic dermatitis, bronchial asthma, allergic rhino-conjunctivitis)<br>5. Written informed consent by the parents as the legal representatives
<br>        Key Inclusion Criteria:<br><br>          1. = 18 years of age at the time Informed Consent is signed.<br><br>          2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).<br><br>          3. Disease duration = 6 years from the first non-Raynaud's symptom.<br><br>          4. No new or increased doses of immunosuppressive medications within 8 weeks prior to<br>             Screening.<br><br>        Key Exclusion Criteria:<br><br>          1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.<br><br>          2. Any of the following values for laboratory tests at Screening:<br><br>               1. A positive pregnancy test in women of childbearing potential;<br><br>               2. Hemoglobin < 9 g/dL for males and < 8 g/dL for females;<br><br>               3. Neutrophils < 1.0 ×10^9/L;<br><br>               4. Platelets < 75 ×10^9/L;<br><br>               5. Creatinine clearance < 50 mL/min according to the Modification of Diet in Renal<br>                  Disease (MDRD) Study equation;<br><br>               6. Aspartate aminotransferase or alanine aminotransferase > 2.0 × upper limit of<br>                  normal.<br><br>          3. Any medical condition or concurrent medical therapies at Screening or Visit 1,<br>             including a history of non-compliance with medical treatments, that may put the<br>             subject at greater safety risk, influence response to study product, or interfere with<br>             study assessments.<br>
Inclusion criteria: <br>•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.<br>•Age at entry: 18-60 years.<br>•WHO activity index = 2<br>•Life expectancy of > 3 months with treatment.<br>•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)<br>•Total bilirubin = 2 x ULN (if >2 x ULN direct bilirubin is required and should be =1.5 x ULN)<br>•Serum creatinine = 2 x ULN<br>•Normal organ function (except HL-related)<br>•Patient has given his/her written informed consent to participate in the trial<br>•Patient agrees to his personal data and tissue material, with due regard for data protection, being used for the study. <br>•Women of childbearing potential must have had a negative serum pregnancy test.<br>•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.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 73<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>
Inclusion criteria: <br>1) Women and men = 18 years of age<br>2) Written consent to study participation after patient information by the investigator<br>3) Diagnosis of bacterial infected eczema based on clinical symptoms in a treatment area between 5 and 25 cm2<br>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)).<br>5) Presence of the clinical parameter exudate/pus” (i.e. score = 1)<br>6) For women of childbearing potential : Application of an efficient contraceptive method  (according to CPMP/ICH/286/95) during the whole study<br>7) For women of childbearing potential: Pregnancy test with negative result prior to study start<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 400<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range <br>
<br>        Inclusion Criteria:<br><br>          -  patient with a diagnosis of fibromyalgia according to the 1990 American College of<br>             Rheumatology (ACR) criteria<br><br>        Exclusion Criteria:<br><br>          -  psychiatric illness<br><br>          -  depression of generalised anxiety disorder<br><br>          -  suicidal risk<br><br>          -  substance abuse<br><br>          -  active cardiac disease<br><br>          -  pulmonary dysfunction<br><br>          -  liver disease<br><br>          -  renal impairment<br><br>          -  autoimmune disease<br><br>          -  chronic inflammatory rheumatoid disease<br><br>          -  current systemic infection<br><br>          -  epileptic<br><br>          -  active cancer<br><br>          -  sleep apnea<br><br>          -  active peptic ulcer<br><br>          -  inflammatory bowel disease<br><br>          -  unstable endocrine disease<br><br>          -  for men : prostatic enlargement of genito-urinary disorders<br><br>          -  for women : pregnancy or breast feeding<br>
Inclusion criteria: <br>•Age 18–75 years<br>•Men and women<br>•Symptomatic heart failure in NYHA II/III stage<br>•LVEF = 50% (during the previous 3 months despite at least 6 weeks of heart failure treatment)<br>•Active B19 (mRNA positive) in endomyocardial<br>•Symptomatic heart failure therapy at stable doses for = 6 weeks<br>•Patients being capable of understanding the nature, importance, and scope of the clinical trial and being able to give written informed consent<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 25<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 25<br>
Inclusion criteria: 1. Adults >=18 years, both males and females<br>2. Patients with all forms of CTD