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A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

The primary objective is to demonstrate superiority in overall survival of amrubicin (40 mg/m2 administered as a 5-minute infusion once daily for 3 consecutive days starting on Day 1 of a 21-day course) compared with topotecan hydrochloride (…

The effectiveness of antidepressants and psychological interventions in treating conversion disorder, motor type: a randomized placebo controlled clinical trial.

To examnine the effectiveness of psychological interventions and psychopharmacological interventions compared to placebo-control.

A Phase III, randomised, parallel group, double-blind, double-dummy, active comparator -controlled, multi-center study to assess the efficacy and safety of PGL4001 (ulipristal) versus GnRH-agonist (leuprorelin 3.75mg) for pre-operative treatment of symptomatic uterine myomas.

Efficacy Objectives:- Primary objective of this study is to demonstrate non inferior efficacy of PGL4001 versus GnRH-agonist to reduce, prior to surgery, excessive uterine bleeding caused by uterine myomas.- Secondary objectives are to demonstrate…

A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function

Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

Concurrent ONce-daily VErsus twice-daily
RadioTherapy: A 2-arm randomised controlled trial of
concurrent chemo-radiotherapy comparing twice-daily
and once-daily radiotherapy schedules in patients with
limited stage small cell lung cancer (SCLC) and good
performance status.

To compare the primary endpoint (overall survival) between the two arms of the studySecondary endpoints are:Local progression-free survivalMetastases-free survivalCTCAE v3.0 toxicityChemotherapy dose intensityRadiotherapy dose intensity

Peripheral targeting of inhaled rhDNase for chronic obstructive asthma in childhood.

Primary Objective: To investigate the effect of treatment with nebulized rhDNase on pulmonary function in children with asthma and persistent obstructive pulmonary function.Secondary Objectives: To investigate the effect of treatment with nebulized…

Hypnotherapy for adolescents and adults with inflammatory bowel disease and symptoms compatible with irritable bowel syndrome

To study the effectiveness of gut-directed hypnotherapy in the treatment of IBS-like symptoms in patients with inflammatory bowel disease.

MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

The purpose of this study is to identify the first time-point the OMERACT RAMRIS score for the activity of synovitis is statistically significantly reduced compared to Baseline, in response to cerolizumab pegol (CZP) therapy. In addition, the early…

Renal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertension

The primary objective of this study is to determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.

A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element*) for the Treatment of up to two De Novo Coronary Artery Lesions

To determine the safety and effectiveness of the PROMUS Element* Everolimus-Eluting Coronary Stent System (Boston Scientific Corporation [BSC], Natick, MA) for the treatment of patients with up to 2 de novo atherosclerotic lesions

A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension

Primary objective• To demonstrate that either dose of ACT-064992 prolongs the time to the first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension.Secondary objectives• To demonstrate that either dose of ACT-…

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus.

The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…

Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial.

To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.

A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the…

A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.

Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.

Doxycycline versus minocycline in the treatment of rosacea: a randomized controlled trial.

To compare the efficacy of doxycycline 40 mg (Efracea) versus minocycline 100 mg treatment in adult patients with papulopustular rosacea.

A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis

The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors Following Failure of at Least Imatinib and Sunitinib

The primary objective of this study is to compare the progression free survival (PFS) following administration of IPI-504 plus best supportive care versus placebo plus best supportive care in patients with metastatic and/or unresectable…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures, Followed by an Open-Label Extension Study

Double-Blind Study CARISEPY3013:The primary objectives of this study are to compare the efficacy safety, and tolerability of carisbamate as adjunctive treatment of partial onset seizures, relative to placebo. The secondary objectives of this study…

A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A

The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.