title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in Patients with Psoriasis.

lead_sponsor: Wyeth Pharmaceuticals France


title: A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

source: euctr

lead_sponsor: F. Hoffmann-La Roche Ltd

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized Phase 3 Study of Pemetrexed in Combination with Cisplatin Versus Cisplatin Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

acronym: Spinnaker

lead_sponsor: Eli Lilly and Company limited


title: A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

acronym: Atacicept frequent MRI study in RMS

lead_sponsor: Merck Serono International S.A.


title: Effect of γ-Secretase Inhibition on the Progression of Alzheimer’s Disease:  LY450139 versus Placebo

lead_sponsor: Eli Lilly and Company


title: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated with Valproate or Lithium and in Need of Further Clinical Improvement.

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomized, Double-Blind, Placebo-Controlled Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety, and Additional Health Outcomes

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Global Medical Affairs


title: A multicenter, randomized, open label,  active-comparator  controlled study to assess the efficacy, safety and tolerability of taspoglutide (RO5073031) compared to exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin,  thiazolidinedione or a combination of both

lead_sponsor: F. Hoffmann-La Roche Ltd.


title: A twelve-month, multicenter, double-masked study of Travoprost / Brinzolamide fixed combination QD AM and Travoprost / Brinzolamide fixed combination QD PM versus COSOPT BID in patients with open-angle glaucoma or ocular hypertension

acronym: Travoprost / Brinzolamide Fixed Combination Once-Daily vs. COSOPT

lead_sponsor: Alcon Research, Ltd.


title: GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe). Workpackage 10: Antibiotic Trial One

acronym: GRACE AT ONE

lead_sponsor: University of Southampton

lead_sponsor_type: academique


title: A randomized, double-blind, parallel group, placebo controlled, multi-center study of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg and tamsulosin hydrochloride OCAS 0.4 mg monotherapy, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component

acronym: Neptune

lead_sponsor: Astellas Pharma Europe B.V.


title: TachoSil versus current practice in dura sealing techniques for the prevention of postoperative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised, controlled, multicentre, parallel group efficacy and safety trial.

acronym: TASALL -TachoSil Against Liquor Leak

lead_sponsor: Nycomed Danmark ApS

status: Ongoing

status_simplified: Ongoing


title: A Randomized Open-Label Phase III Trial of MK-3475 versus Platinum based Chemotherapy in 1L Subjects with PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

acronym: MK-3475 versus SOC in 1L Subjects with PD-L1 Strong Metastatic NSCLC

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma

lead_sponsor: Genmab A/S


title:
A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Crohn’s Disease (CD) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.
 Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date: 06-Dec-2006).

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy

lead_sponsor: GlaxoSmithKline Research & Development Ltd.


title: A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis

lead_sponsor: AOP Orphan Pharmaceuticals AG


title: An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients with Anaemia Associated with Chronic Kidney Disease.

acronym: Dynepo long-term safety study

lead_sponsor: Shire


title: Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release to 10 mg Donepezil Immediate Release in Patients with Moderate to Severe Alzheimer’s Disease

lead_sponsor: Eisai Ltd


title: A randomized, double blind, double dummy, placebo controlled study to evaluate the efficacy and safety of solifenacin succinate (5 and 10mg once daily) against placebo and oxybutynin hydrochloride (5 mg three times daily) in the treatment of subjects with neurogenic detrusor overactivity.

acronym: SONIC


title: A phase II, multicentre, randomised, assessor.blinded, active-comparator, parallel-group dose finding trial to evaluate AS900672-Enriched versus follitropin alfa (GONAL-f) in oligo-anovulatory infertile women undergoing ovulation induction (OI)

acronym: AS900672-Enriched Phase II in OI

lead_sponsor: Merck Serono SA International


title: A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole versus other Atypical Antipsychotics in the Treatment of Schizophrenic Patients with Metabolic Syndrome


title: Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole in Eradication of Helicobacter pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given x 7 days

lead_sponsor: Axcan Pharma Inc.


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECEIPIENTS OF ORTHOTOPIC LIVER TRANSPLANTS

lead_sponsor: ViroPharma Incorporated


title: A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel-group Study to Assess the Time to Response to Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy.

lead_sponsor: Shire Pharmaceutical Development Ltd.

status_simplified: Unknown


title: A Randomized, Open-Label, Parallel-Arm, Noninferiority Comparison of the Effects of Two Doses of LY2189265 and Insulin Glargine on Glycemic Control in Patients with Type 2 Diabetes on Stable Doses of Metformin and Glimepiride (AWARD-2: Assessment of Weekly AdministRation of LY2189265 in Diabetes-2)

acronym: GBDB

lead_sponsor: Eli Lilly & Company - Indianapolis


title: Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without BSI-201 (SAR240550) (a PARP1 Inhibitor) in Patients with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC)

lead_sponsor: BiPar Sciences, Inc.


title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

lead_sponsor: Shire Human Genetic Therapies, Inc.


title:
A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy.
 Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 06-Dec-2006) and Administrative Letter 01.


title: An open-label, randomized, multicenter, parallel group study to demonstrate correction of anemia using once monthly subcutaneous injections of RO0503821 in patients with chronic kidney disease who are not on dialysis

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Phase 3, Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Hip Replacement Surgery


title: Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy

acronym: HMGD(a)

lead_sponsor: Eli Lilly and Company Limited


title:
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
 Revised Protocol Number: 01, Incorporates amendment(s) 02

lead_sponsor: Bristol-Meyers Squibb International Corporation


title:
FondaparinUx Trial with UFH during Revascularization in Acute Coronary Syndromes (FUTURA)
 A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with UA/NSTEMI initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)

acronym: OASIS 8 (FUTURA)

lead_sponsor: GlaxoSmithKline R & D


title: D1532C00016: A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Docetaxel, Compared with Docetaxel Alone, in 2nd Line Patients with KRAS Mutation Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

lead_sponsor: AstraZeneca AB


title: An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial

acronym: RESTORE EXTENSION

lead_sponsor: Novartis Pharma Services AG


title: Safety and Efficacy of Exenatide Once Weekly versus Liraglutide in subjects with type 2 diabetes and inadequate glycemic control treated with lifestyle modification and oral antidiabetic medications

acronym: GWDE

lead_sponsor: Eli Lilly and Company


title: A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development


title: A Phase II, randomized, parallel group safety, efficacy, and pharmacokinetics study of BI 10773 (1mg, 5mg, 10mg, 25mg, and 50mg) administered orally once daily over 12 weeks compared double blind to placebo with an additional open-label sitagliptin arm in type 2 diabetic patients with insufficient glycemic control despite metformin therapy

lead_sponsor: Boehringer Ingelheim France


title: International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukemia

acronym: INTERFANT 06

lead_sponsor: Dutch Childhood Oncology Group


title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients with Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

lead_sponsor: Turning Point Therapeutics, Inc.


title: A Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Retention Rate, Efficacy, Safety, and Tolerability of Carisbamate, Topiramate and Levetiracetam as Adjunctive Therapy in Subjects with Partial Onset Seizures

acronym: CaReS (Carisbamate Retention Study)

lead_sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC


title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-α antagonist therapy

acronym: Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-α antagonist

lead_sponsor: Genmab A/S


title: A randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed-dose study evaluating the efficacy and safety of three dosages of Lu AA21004, in acute treatment of Major Depressive Disorder.

acronym: Not applicable

lead_sponsor: H. Lundbeck A/S


title: EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2 093) AS THERAPY FOR PATIENTS WITH POST-HERPETIC NEURALGIA: A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIAL

lead_sponsor: BIAL - Portela & Ca, S.A.


title: A Phase IV multicentre, randomised, double-blind, placebo controlled, trial to evaluate the safety and efficacy of Raptiva ® in the treatment of subjects with moderate to severe plaque psoriasis involving hands and/or feet, with or without pustules.

acronym: TRUST study: Raptiva ® in hands & foot psoriasis

lead_sponsor: Merck Serono International SA


title: Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas.  A phase 3 study comparing an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g (LEO 80190 ointment) with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone, all applied once daily in the treatment of psoriasis vulgaris on the face and on the intertriginous areas, followed by a 52-week safety study in patients with psoriasis vulgaris on the face and on the intertriginous areas.

lead_sponsor: LEO Pharma A/S


title: A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures

lead_sponsor: SCHWARZ BIOSCIENCES, Inc.


title: Evaluation of the anti-arrhythmic effects of 3 oral dosages of S 44121 versus placebo in patients with chronic heart failure and left ventricular systolic dysfunction at risk for ventricular arrhythmia. A 12-week, randomized, double-blind, parallel-group, placebo controlled, international multicentre study.

lead_sponsor: Institut de Recherches Internationales Servier


title: A  Kaletra ONCE daily Randomised Trial of the pharmacokinetics, safety and efficacy of twice-daily versus once-daily lopinavir/ritonavir tablets dosed by weight as part of combination antiretroviral therapy in HIV-1 infected children (PENTA 18)

acronym: KONCERT

lead_sponsor: Paediatric European Network for Treatment of AIDS (PENTA) Foundation


title: A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Celltrion, Inc.

status: Prematurely Ended


title: A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP 2)/Calcium Phosphate Matrix (CPM) in Closed Diaphyseal Tibial Fractures

lead_sponsor: Wyeth Pharmaceuticals Inc.


title: A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura

lead_sponsor: Amgen Inc.


title: A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent (ARTS – AVODART after Radical Therapy for prostate cancer Study)

acronym: ARTS

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A Phase II study of Tarceva® in Combination with Avastin® versus chemotherapy plus Avastin® in 1st line advanced NSCLC patients

lead_sponsor: F. Hoffmann-La Roche


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS® methylphenidate (54 and 72 mg/day) in Adults with Attention Deficit/Hyperactivity Disorder.

acronym: Lamda 2

lead_sponsor: Janssen-Cilag International N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium


title: A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 in patients with Major Depressive Disorder


title: A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis.

acronym: MYCYC

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: A double blind, randomized, placebo controlled, parallel group dose range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

lead_sponsor: GW Pharma Ltd.


title: An Open-Label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory, CD22- Positive, Follicular B-Cell Non Hodgkin’s Lymphoma

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc


title: Randomized Trial to Evaluate the Efficacy and Safety of Cinacalcet Treatment in Combination with Low Dose Vitamin D for the Treatment of Subjects with Secondary Hyperparathyroidism (SHPT) Recently Initiating Hemodialysis

lead_sponsor: Amgen Inc


title: 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

lead_sponsor: Infinity Pharmaceuticals, Inc.


title: PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes

acronym: SAVOR

lead_sponsor: AstraZeneca AB


title: Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Investigate the MRI Efficacy and the Safety of Six Months' Administration of Firategrast (150 – 1200mg twice daily) in Subjects with Relapsing-Remitting Multiple Sclerosis

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Phase III Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy


title: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

acronym: TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for NSCLC With EGFR Exon 20 Inser

lead_sponsor: Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals is a wholly owned subsidiary of Takeda Pharmaceutical


title: A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease.

acronym: The Vermeer study

lead_sponsor: Solvay pharmaceuticals


title: A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents. (ADHD-LIFE Study)

acronym: (ADHD-LIFE Study)

lead_sponsor: Eli Lilly and Company


title: An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly  vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis

lead_sponsor: F. Hoffmann-La Roche Ltd


title: Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


title: Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A randomized, double-masked, multicenter, laser-controlled Phase III study assessing the efficacy and safety of ranibizumab (intravitreal injections) as adjunctive and mono-therapy in patients with visual impairment due to diabetic macular edema

acronym: RESTORE

lead_sponsor: Novartis Pharma Services AG


title: A randomized, double-blind, placebo-controlled, Phase III trial of 2 regimens of telaprevir (with and without delayed start) combined with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) in subjects with chronic genotype 1 hepatitis C infection who failed prior pegylated interferon plus ribavirin treatment.

acronym: REALIZE

lead_sponsor: Tibotec BVBA


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

lead_sponsor: Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK


title: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure

acronym: ASCEND-HF

lead_sponsor: Janssen-Cilag International NV,Turnhoutseweg 30, 2340  Beerse, Belgium


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CROHN’S DISEASE

lead_sponsor: Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ


title: A Clinical Safety and Efficacy Comparison of NEVANAC® 0.1% to Vehicle  Following Cataract Surgery in Diabetic Retinopathy Patients

acronym: Macular Edema Incidence/Severity Reduction with NEVANAC®

lead_sponsor: ALCON RESEARCH, LTD.


title: A phase IV prospective, multicentre, randomized, open-label trial to assess the efficacy and safety of GONAL f® at a dose based on subject baseline characteristics determined according to the CONSORT calculator compared with a standard dose of GONAL f® 150 IU per day for ovarian stimulation in women undergoing assisted reproductive technology (ART)

acronym: CONSORT RCT in ART

lead_sponsor: Merck Serono International S.A.


title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy

acronym: LVIK

lead_sponsor: Eli Lilly and Company Limited


title: A 52-week randomised, controlled, open label, multicentre, multinational treat-to-target trial comparing the efficacy and safety of SIBA and insulin glargine, both injected once daily in combination with oral anti-diabetic drugs (OAD), in subjects with type 2 diabetes mellitus currently treated with OAD(s) and qualifying for more intensified treatment

lead_sponsor: Novo Nordisk A/S


title: An eight-week, multinational, multicenter, double-blind, active- and placebo-controlled clinical trial evaluating the efficacy and tolerability of three fixed doses of SSR125543 (20 mg daily, 50 mg daily and 100 mg daily) in outpatients with major depressive disorder.

acronym: AGATE

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: A Randomized, Open-Label, Multicenter, Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

lead_sponsor: Janssen-Cilag International N.V.


title:
A MULTICENTER, OPEN-LABEL, LONG-TERM SAFETY STUDY OF AR101 CHARACTERIZED ORAL DESENSITIZATION IMMUNOTHERAPY IN SUBJECTS WHO PARTICIPATED IN A PRIOR AR101 STUDY

 Étude multicentrique, en ouvert et à long terme portant sur la sécurité d’emploi de l’AR101, une immunothérapie de désensibilisation spécifique par voie orale, chez des patients ayant participé à une étude antérieure sur l’AR101

acronym:
Long-term Safety Study of AR101 CODIT™

 Étude de sécurité à long terme sur l’AR101 CODIT™

lead_sponsor: Aimmune Therapeutics, Inc.


title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

 Essai d’extension en ouvert visant à évaluer la sécurité d’emploi à long terme du ZX008 (chlorhydrate de fenfluramine) en solution buvable en tant que traitement adjuvant des crises convulsives chez des patients atteints de troubles convulsifs rares tels que des encéphalopathies épileptiques, y compris du syndrome de Dravet et du syndrome de Lennox-Gastaut

lead_sponsor: Zogenix International Limited


title:
A phase III, randomized, controlled, open-label, multicenter, global study of capmatinib versus SoC docetaxel chemotherapy in previously treated patients with EGFR wt, ALK negative, locally advanced or metastatic (stage IIIB/IIIC or IV) NSCLC harboring MET exon 14 skipping mutation (METΔex14)

 Etude internationale de phase III, multicentrique, randomisée, en ouvert, évaluant capmatinib versus docétaxel chez des patients atteints de cancer bronchique non à petites cellules, localement avancé ou métastatique, avec mutations responsables d’un saut de l’exon 14 de MET (METΔex14) et préalablement traités

lead_sponsor: Novartis Pharma AG


title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

lead_sponsor: Rigel Pharmaceuticals, Inc.


title: Randomized, double blind, placebo controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of lung function, mucus plugging and other lung imaging parameters in patients with asthma

acronym: VESTIGE

lead_sponsor: Sanofi-Aventis Groupe


title: Use of Duloxetine or Pregabalin in Monotherapy versus Combination Therapy of Both Drugs in Patients with Painful Diabetic Neuropathy “The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study”

acronym: HMGQ

lead_sponsor: Eli Lilly and Company


title: Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Phase 3b, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients with Prostate Cancer

lead_sponsor: Ferring Pharmaceuticals A/S


title: A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma

lead_sponsor: AstraZeneca AB


title: Single agent phase II study of Forodesine (BCX1777) in the treatment of cutaneous T-Cell Lymphoma

acronym: forodesine in CTCL

lead_sponsor: BioCryst Pharmaceuticals, Inc.


title: A Phase III, randomized, double-blind trial of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects

acronym: ECHO Simplified Pill Regimen In Naive patients with TMC278

lead_sponsor: Tibotec Pharmaceuticals Limited


title: A confirmatory, placebo-controlled, randomised, double-blind, single-dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone – naloxone ratio with an improved bowel function and a comparable analgesic efficacy compared to hydromorphone alone

acronym: Optimisation of Hydromorphone - Naloxone Ratio for the treatment of pain

lead_sponsor: Mundipharma Research GmbH & Co. KG


title: A PHASE 2, RANDOMIZED, DOUBLE-MASKED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INTRAVITREOUS INJECTIONS OF E10030 (ANTI-PDGF PEGYLATED APTAMER) GIVEN IN COMBINATION WITH LUCENTIS® IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

acronym: REGRESS

lead_sponsor: OPHTHOTECH CORPORATION


title: Efficacy of once weekly exenatide long acting release and once daily insulin glargine in patients with Type 2 diabetes treated with metformin alone or in combination with sulphonylurea.

acronym: GWBR(a)


title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients with Septic Shock

acronym: PROWESS-SHOCK


title: A Phase II, Dose-Escalation to rash Trial of Erlotinib (Tarceva®) plus Gemcitabine in Patients With Metastatic Pancreatic Cancer.

acronym: RACHEL

lead_sponsor: F. Hoffmann-La Roche


title: A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients with Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck

lead_sponsor: Amgen Inc


title: An open-label extension study following a double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures.

lead_sponsor: Eisai Ltd


title: Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP MULTI-CENTER COMPARATIVE FLEXIBLE-DOSE STUDY OF PREGABALIN VERSUS LEVETIRACETAM AS ADJUNCTIVE THERAPY TO REDUCE SEIZURE FREQUENCY IN SUBJECTS WITH PARTIAL SEIZURES (A0081157).

lead_sponsor: Pfizer Inc,East 42nd street,New york, NY10017, USA


title: A RANDOMIZED PLACEBO-CONTROLLED TRIAL OF THE EFFICACY AND TOLERABILITY OF FLEXIBLY DOSED PREGABALIN IN THE TREATMENT OF CANCER-INDUCED BONE PAIN.

lead_sponsor: Pfizer


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26 Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy, Safety, and Tolerability of JNJ 28431754 (Canagliflozin) Compared with Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

acronym: The CANTATA-MP Trial

lead_sponsor: Janssen-Cilag International NV


title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis


title: Superiority of insulin glargine Lantus vs. NPH: “Treat to Normoglycemia concept”. Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled.

acronym: LANCELOT

lead_sponsor: SANOFI-AVENTIS GROUPE


title: A 12-week, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of prucalopride in subjects with chronic non-cancer pain suffering from opioid induced constipation

lead_sponsor: Movetis NV


title: A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

acronym: Pembrolizumab plus axitinib vs. sunitinib monotherapy in advanced/metastatic renal cell carcinoma

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects ≥ 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation

lead_sponsor: Agios Pharmaceuticals, Inc.


title:
A phase III, multicenter, randomized, open-label trial toevaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE)

 Étude de phase III, multicentrique, randomisée, ouverte, évaluant l'efficacité et la tolérance du ribociclib associé à l'endocrinothérapie en tant que traitement adjuvant chez des patients atteints d'un cancer du sein précoce positif aux récepteurs hormonaux, HER2 négatif (New Adjuvant TriAl with Ribociclib [LEE011] : NATALEE).

lead_sponsor: Novartis Pharma AG


title: Phase IIIb randomized trial comparing irradiation plus long term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG. Pegasus

lead_sponsor: European Organisation for Research and Treatment of Cancer (EORTC)


title:
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in Children and Adolescents with Newly Diagnosed Type
 1 Diabetes (T1D)

 Étude clinique internationale de phase III, randomisée, en double insu, contrôlée contre placebo, évaluant l’efficacité et la tolérance du téplizumab (PRV-031), un anticorps monoclonal anti-CD3 humanisé, ne se liant pas au récepteur Fc, chez des enfants et des adolescents présentant un diabète de type 1 (DT1) nouvellement diagnostiqué

acronym: PROTECT

lead_sponsor: Provention Bio, Inc.


title:
A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

 Etude de phase 3 randomisée d’une durée de 52 semaines, en double aveugle, contrôlée par placebo évaluant la sécurité d'emploi et l'efficacité de la relamoreline chez des patients atteints de gastroparésie diabétique

acronym:
Diabetic Gastroparesis Study 4

 Étude 4 évaluant la gastroparésie diabétique

lead_sponsor: Allergan Ltd.


title: A PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO)

lead_sponsor: Alexion Pharmaceuticals, Inc.


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY  10017


title:
LUCY - Lynparza Breast Cancer Real World Utility, Clinical Effectiveness and Safety Study
 A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations

 LUCY – Utilité du Lynparza en situation réelle dans le traitement du cancer du sein, Étude sur l'efficacité et la tolérance cliniques.
 Étude multicentrique de phase IIIb, à un seul groupe, menée en ouvert, évaluant l'olaparib administré en monothérapie dans le traitement de patients présentant un cancer du sein HER2- avec mutations germinales BRCA1/2

acronym:
LUCY

 LUCY

lead_sponsor: AstraZeneca AB


title: A Phase 3 multicenter, randomized, double-blind, placebo-controlled, clinical study to assess the efficacy and safety of linzagolix in subjects with moderate to severe endometriosis-associated pain.

acronym: Edelweiss 3

lead_sponsor: ObsEva S.A.


title: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix (GnRH Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

lead_sponsor: Ferring Pharmaceuticals A/S


title: Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy

acronym: REDUCE-RISKincd-PIBD-TRIAL

lead_sponsor: PIBDNet


title: A multi-center, open-label, uncontrolled, single-arm, extension study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease

lead_sponsor: Idorsia Pharmaceuticals Ltd


title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (FASLODEX) with or without PD-0332991 (PALBOCICLIB) ± Goserelin in Women with Hormone Receptor-Positive, Her2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy

lead_sponsor: Pfizer Inc 235 East 42nd Street, New York, NY10017


title:
A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal  Cancer: Phase 3 Preceded by Dose-Finding in Phase 1

 Étude de phase III randomisée, menée en double aveugle, contrôlée contre placebo évaluant FPA144 et le FOLFOX-6 modifié chez des patients atteints d'un cancer gastrique ou gastro-œsophagien avancé n'ayant reçu aucun traitement antérieur : phase III précédée d'une recherche de dose en phase I

acronym: FIGHT

lead_sponsor: Five Prime Therapeutics, Inc.


title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

lead_sponsor: Genmab A/S


title:
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer

 Étude de phase 3, randomisée, en ouvert et contrôlée, évaluant le cabozantinib (XL184) en association avec l’atézolizumab vs un deuxième traitement hormonal novateur (THN) chez des patients atteints d’un cancer de la prostate métastatique et résistant à la castration

lead_sponsor: Exelixis, Inc.


title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy

lead_sponsor: Sierra Oncology, Inc.


title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer – (KEYNOTE-355)

acronym: A Phase III Study of Chemotherapy ± Pembrolizumab in 1L Triple Negative Breast Cancer

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD- 1/L1 and VEGF-Targeted Therapies

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc


title:
A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors

 Etude de phase III, multicentrique, randomisée, en ouvert, évaluant ABL001 par voie orale versus bosutinib chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC-PC) précédemment traités par au moins 2 inhibiteurs de tyrosine kinase

lead_sponsor: Novartis Pharma AG


title: Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)

lead_sponsor: Sanofi-Aventis Recherche & Developpement


title: A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma

acronym: SUNNIFORECAST

lead_sponsor: Goethe University Frankfurt


title:
A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects from 5 to < 18 Years of Age with Overactive Bladder

 Etude de phase 3, multicentrique, randomisée, en groupe parallèle, en double aveugle, contrôlée contre placebo visant à évaluer l’efficacité, la tolérance et la pharmacocinétique d’un traitement séquentiel par Mirabégron chez des enfants âgés de 5 à 18 ans présentant une vessie hyperactive

acronym:
Dolphin Study

 Etude Dolphin

lead_sponsor: Astellas Pharma Global Development Inc.


title: A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease

lead_sponsor: Amicus Therapeutics, Inc.


title:
A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib Hydrochloride to Sorafenib in Subjects With Refractory Advanced Renal Cell Carcinoma

 Étude de phase 3, multicentrique, ouverte, randomisée comparant le tivozanib au soréfanib chez des patients présentant un cancer du rein métastatique réfractaire

lead_sponsor: AVEO PHARMACEUTICALS, INC.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab forStage IIIB or IV Non-Small Cell Lung Cancer

lead_sponsor: GlaxoSmithKline Research & Development Ltd.


title: Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

acronym: Phase 3 Study of Pembrolizumab with/without Epacadostat in second line Urothelial Carcinoma

lead_sponsor: Incyte Corporation


title:
A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

 Étude de phase IIb en ouvert évaluant l’efficacité et la sécurité d’emploi de l’ABX464 en tant que traitement d’entretien chez des patients atteints de rectocolite hémorragique modérée à sévère.

lead_sponsor: ABIVAX


title:
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy

 Étude de phase 2, randomisée, en double aveugle, contrôlée contre placebo, évaluant la sécurité et l’efficacité de l’Avacopan (CCX168) chez des patients atteints de glomérulopathie à C3

lead_sponsor: ChemoCentryx, Inc.


title:
Corticosteroids or clobazam for ESES syndrome: a European, multicenter,
 randomized, controlled clinical trial

acronym: RESCUE ESES: Randomized European trial of Steroids vs Clobazam Usage

lead_sponsor: University Medical Center Utrecht


title:
A Randomized, Double blind, Active Control Study of the Safety and Efficacy of PRX-102 compared to Agalsidase Beta on Renal Function in Patients with Fabry Disease Previously Treated With Agalsidase
  Beta

 Étude randomisée, en double aveugle, contre comparateur actif, de la sécurité et l’efficacité de PRX-102 par rapport à l’agalsidase bêta sur la fonction rénale chez des patients atteints de la maladie de Fabry précédemment traités par agalsidase bêta

lead_sponsor: Protalix Ltd.


title: A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab versus Single Agent Chemotherapy per Physician’s Choice for Metastatic Triple Negative Breast Cancer (mTNBC) – (KEYNOTE-119)

acronym: A Study of Single Agent Pembrolizumab vs Single Agent Chemotherapy for mTNBC

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc


title:
An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10

 Etude exploratoire de maintenance évaluant l’effet du BI 655064 chez des patients atteints de néphropathie lupique et ayant présenté une réponse significative soit à la fin de l’étude 1293.10 soit après un traitement d’induction en dehors de l’étude 1293.10

lead_sponsor: Boehringer Ingelheim France


title:
A PHASE 3, MULTICENTER, OPEN-LABEL 52-WEEK EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF ORAL ATOGEPANT FOR THE PREVENTION OF MIGRAINE IN PARTICIPANTS WITH CHRONIC OR EPISODIC MIGRAINE

 Étude d’extension de phase III multicentrique, menée en ouvert, d’une durée de 52 semaines visant à évaluer l’innocuité et la tolérance à long terme de l’atogépant par voie orale pour la prévention de la migraine chez des patients présentant des migraines chroniques ou épisodiques

lead_sponsor: Allergan Limited


title:
A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle-Invasive Bladder Cancer Patients  (POTOMAC)

 Etude ouverte, randomisée, multicentrique, de phase III évaluant l’association de durvalumab avec le Bacille de Calmette-Guerin (BCG) versus le BCG seul chez des patients non préalablement traités par BCG ayant une tumeur vésicale de haut risque n’infiltrant pas le muscle (POTOMAC)

acronym: POTOMAC

lead_sponsor: AstraZeneca AB


title:
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

 Etude internationale de phase III, en double aveugle, multicentrique, contrôlée versus placebo évaluant le durvalumab en traitement néoadjuvant/adjuvant chez des patients atteints d’un cancer du poumon non à petites cellules de stade II et III résécable (AEGEAN)

acronym: AEGEAN


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

lead_sponsor: Principia Biopharma, Inc.


title: Impact of Aggressive Empiric Antibiotic Therapy and Duration of Therapy on the Emergence of Antimicrobial Resistance During the Treatment of Hospitalized Subjects With Pneumonia Requiring Mechanical Ventilation

summary: The primary objective of this study is to demonstrate a low rate of emergence of antibiotic resistance in P. aeruginosa and Acinetobacter spp during the treatment of hospitalized patients with pneumonia requiring mechanical ventilation treated with PD optimized meropenem administered as a prolonged infusion in combination with a parenteral aminoglycoside plus tobramycin by inhalation (Group 1) compared to therapy with meropenem alone (Group 2 - control arm).

status: Terminated

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

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ReferenceCitation: Nord CE, Lindmark A, Persson I. Susceptibility of Anaerobic Bacteria to SM 7338. 28th ICAAC, Los Angeles, October 1988. Abstract 596.

ReferenceCitation: Okuda T, Fukasawa M, Tanio T, et al. SM 7338, A New Carbapenem Antibacterial: In Vitro and In Vivo Antibacterial Activities. 27th ICAAC, New York, October 1987. Abstract 757.

ReferenceCitation: Quinn JP, Studemeister AE, DiVincenzo CA, Lerner SA. Resistance to imipenem in Pseudomonas aeruginosa: clinical experience and biochemical mechanisms. Rev Infect Dis. 1988 Jul-Aug;10(4):892-8. Review.

ReferenceCitation: Sanford Guide to Antimicrobial Therapy. Thirty-third Edition, 2003. Gilbert DN, Moellering RC, Sande MA.

ReferenceCitation: Scheld WM, Mandell GL. Nosocomial pneumonia: pathogenesis and recent advances in diagnosis and therapy. Rev Infect Dis. 1991 Jul-Aug;13 Suppl 9:S743-51. Review.

ReferenceCitation: Slaney L, Chubb H, Mohammed Z, et al. In Vitro Activity of SM 7338 Against Neisseria gonorrhoeae (Gc), Haemophilus ducreyi (Hd) and Haemophilus influenzae. 28th ICAAC, Los Angeles, October 1988. Abstract 604.

ReferenceCitation: Strasbaugh LJ. Nosocomial repiratory infections. In: Mandell GL, Bennett JE, Dolin R, editors. Principles and practice of infectious disease. Philadelphia: Churchill Livingstone, 2000: 3021-3026.

ReferenceCitation: Sumita Y, Fukasawa M, Okunda T. SM 7338, A New Carbapenem Antibacterial: Affinities for PBP's and Morphological Changes. 27th ICAAC, New York, October 1987. Abstract 756.

ReferenceCitation: Sumita Y, Inoue M, Mitsuhashi S. In Vitro Antibacterial Activity of SM 7338. 28th ICAAC, Los Angeles, October 1988. Abstract 600.

ReferenceCitation: Sunagawa M, Matsumura H, Inoue T, et al. SM 7338, A New Carbapenem Antibacterial: Structure-Activity Relations and Physiochemical Properties. 27th ICAAC, New York, October 1987. Abstract 752.

ReferenceCitation: TALKE H, SCHUBERT GE. [ENZYMATIC UREA DETERMINATION IN THE BLOOD AND SERUM IN THE WARBURG OPTICAL TEST]. Klin Wochenschr. 1965 Feb 1;43:174-5. German.

ReferenceCitation: Torres A, Aznar R, Gatell JM, Jiménez P, González J, Ferrer A, Celis R, Rodriguez-Roisin R. Incidence, risk, and prognosis factors of nosocomial pneumonia in mechanically ventilated patients. Am Rev Respir Dis. 1990 Sep;142(3):523-8.

ReferenceCitation: Torres A, Bauer TT, León-Gil C, Castillo F, Alvarez-Lerma F, Martínez-Pellús A, Leal-Noval SR, Nadal P, Palomar M, Blanquer J, Ros F. Treatment of severe nosocomial pneumonia: a prospective randomised comparison of intravenous ciprofloxacin with imipenem/cilastatin. Thorax. 2000 Dec;55(12):1033-9.

ReferenceCitation: Trouillet JL, Chastre J, Vuagnat A, Joly-Guillou ML, Combaux D, Dombret MC, Gibert C. Ventilator-associated pneumonia caused by potentially drug-resistant bacteria. Am J Respir Crit Care Med. 1998 Feb;157(2):531-9.

ReferenceCitation: Vetter N. The Use of Meropenem ('Merrem'/'Meronen') in the Therapy of Hospital-acquired Lower Respiratory Infections: a Review of Clinical Experience. 18th International Congress of Chemotherapy, Stockholm, Sweden, 27 June-2 July, 1993. Abstract 70.

ReferenceCitation: Wise R, Andrews JM, Ashby JP. The Bactericidal Activity of the Carbapenem, SM 7338, Alone and in Combination. 28th ICAAC, Los Angeles, October 1988. Abstract 605.

ReferenceCitation: World Health Organization. Draft Global Strategy for the Containment of Antimicrobial Resistance. Available on the Internet at http://www.who.int/emc/amr.htm

ReferenceType: derived

ReferenceCitation: Drusano GL, Corrado ML, Girardi G, Ellis-Grosse EJ, Wunderink RG, Donnelly H, Leeper KV, Brown M, Malek T, Hite RD, Ferrari M, Djureinovic D, Kollef MH, Mayfield L, Doyle A, Chastre J, Combes A, Walsh TJ, Dorizas K, Alnuaimat H, Morgan BE, Rello J, Mazo CA, Jones RN, Flamm RK, Woosley L, Ambrose PG, Bhavnani S, Rubino CM, Bulik CC, Louie A, Vicchiarelli M, Berman C. Dilution Factor of Quantitative Bacterial Cultures Obtained by Bronchoalveolar Lavage in Patients with Ventilator-Associated Bacterial Pneumonia. Antimicrob Agents Chemother. 2017 Dec 21;62(1). pii: e01323-17. doi: 10.1128/AAC.01323-17. Print 2018 Jan. Erratum in: Antimicrob Agents Chemother. 2018 Mar 27;62(4):.

name: Institute for Therapeutic Innovation, Department of Medicine, University of Florida, College of Medicine, Research and Academic Center, Lake Nona, Florida, USA

family: Drusano

full_name: George L. Drusano

given: George L.

sequence: first

name: Consultant in Infectious Diseases, Perkasie, Pennsylvania, USA

family: Corrado

full_name: Michael L. Corrado

given: Michael L.

sequence: additional

name: INC Research, New Hope, Pennsylvania, USA

family: Girardi

full_name: Gino Girardi

given: Gino

name: Zavante Therapeutics, Inc., San Diego, California, USA

family: Ellis-Grosse

full_name: Evelyn J. Ellis-Grosse

given: Evelyn J.

name: Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA

family: Wunderink

full_name: Richard G. Wunderink

given: Richard G.

family: Donnelly

full_name: Helen Donnelly

given: Helen

name: Emory University School of Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, Atlanta, Georgia, USA

family: Leeper

full_name: Kenneth V. Leeper

given: Kenneth V.

family: Brown

full_name: Mona Brown

given: Mona

family: Malek

full_name: Tasnova Malek

given: Tasnova

name: Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA

family: Hite

full_name: Robert Duncan Hite

given: Robert Duncan

family: Ferrari

full_name: Michelle Ferrari

given: Michelle

family: Djureinovic

name: Washington University School of Medicine, Division of Pulmonary and Critical Care Medicine, St. Louis, Missouri, USA

name: Intensive Care Unit and Intermediate Care Unit, University of Paris 6, Pierre-et-Marie Curie, Hôpital Pitié-Salpêtrière, Paris, France

name: Weill Cornell Medical Center of Cornell University, New York, New York, USA

name: University of Florida School of Medicine, and MICU, Shands Teaching Hospital, Gainesville, Florida, USA

name: Critical Care Department, CIBERES, Universitat Autonoma de Barcelona, Barcelona, Spain

name: Jones Microbiology Institute, North Liberty, Iowa, USA

name: Institute for Clinical Pharmacodynamics, Schenectady, New York, USA

location_facility: Weill Cornell Medical Center of Cornell University

location_facility: Washington University in St. Louis School of Medicine

location_facility: Cleveland Clinic Lerner College of Medicine

location_facility: Institut de Cardiologie, Groupe Hospitalier Pitie-Salpetriere

location_facility: UFL Department of Medicine: Pulmonary, Critical Care and Sleep Medicine


title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation

summary: This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.

ReferenceType: result

ReferenceCitation: Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, Garcia-Valdecasas JC, McAlister V, Mirza DF; rFVIIa OLT Study Group. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl. 2005 Aug;11(8):973-9.

ReferenceCitation: Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33.

lead_sponsor: Novo Nordisk A/S

location_country:
Sweden
France
Australia
Spain
Germany
United Kingdom
Canada

intervention_type: Drug


title: International Retrospective Study of Pipeline Embolization Device

acronym: IntrePED

summary:
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed to observe and capture information from numerous hospitals.

Data collection will be initiated starting March 2012 and continue until approximately April 2017.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Park MS, Kilburg C, Taussky P, Albuquerque FC, Kallmes DF, Levy EI, Jabbour P, Szikora I, Boccardi E, Hanel RA, Bonafé A, McDougall CG. Pipeline Embolization Device with or without Adjunctive Coil Embolization: Analysis of Complications from the IntrePED Registry. AJNR Am J Neuroradiol. 2016 Jun;37(6):1127-31. doi: 10.3174/ajnr.A4678. Epub 2016 Jan 14.

family: Park

full_name: M.S. Park

family: Kilburg

full_name: C. Kilburg

given: C.

family: Taussky

full_name: P. Taussky

given: P.

family: Albuquerque

full_name: F.C. Albuquerque

family: Kallmes

full_name: D.F. Kallmes

family: Levy

full_name: E.I. Levy

family: Jabbour

full_name: P. Jabbour

family: Szikora

full_name: I. Szikora

given: I.

family: Boccardi

full_name: E. Boccardi

given: E.

family: Hanel

full_name: R.A. Hanel

family: Bonafé

full_name: A. Bonafé

given: A.

family: McDougall

full_name: C.G. McDougall

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Neuroradiology

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: American Society of Neuroradiology (ASNR)

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Italy
United States
France
Hungary
Argentina
Canada

location_facility: University of Buffalo Neurosurgery, Buffalo General Hospital

location_facility: Fort Sanders Regional Medical Center, Neurovascular Research


title: A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

summary: The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

study_start_date_type: Actual

ReferenceCitation: Camilleri M, Hale M, Morlion B, Tack J, Webster L, Wild J. Naldemedine Improves Patient-Reported Outcomes of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain in the COMPOSE Phase 3 Studies. J Pain Res. 2021 Jul 16;14:2179-2189. doi: 10.2147/JPR.S282738. eCollection 2021.

family: Camilleri

full_name: Michael Camilleri

given: Michael

family: Hale

full_name: Martin Hale

given: Martin

family: Morlion

full_name: Bart Morlion

given: Bart

family: Tack

full_name: Jan Tack

given: Jan

family: Webster

full_name: Lynn Webster

given: Lynn

family: Wild

full_name: James Wild

given: James

currency_apc_doaj: USD

journal_name: Journal of Pain Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via OAI-PMH doi match)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Webster LR, Hale ME, Yamada T, Wild JE. A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy. J Pain Res. 2020 Mar 24;13:605-612. doi: 10.2147/JPR.S237833. eCollection 2020.

full_name: Lynn R Webster

given: Lynn R

full_name: Martin E Hale

given: Martin E

family: Yamada

full_name: Tadaaki Yamada

given: Tadaaki

full_name: James E Wild

given: James E

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Wild J, Webster L, Yamada T, Hale M. Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients ≥ 65 Years of Age. Drugs Aging. 2020 Apr;37(4):271-279. doi: 10.1007/s40266-020-00753-2.

location_country:
Italy
Austria
United States
South Africa
Sweden
Germany
France
Czechia
Poland
Israel
Hungary
Australia
Spain
Denmark
Canada
United Kingdom


title: Natural History Study of Children With Metachromatic Leukodystrophy

summary: The purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (MLD).

time_perspective: Prospective

lead_sponsor: Shire

location_country:
United States
Brazil
Germany
France
Japan
Belgium
Argentina
Turkey
Denmark
Canada

location_facility: The Jikei University School Of Medicine - Institute Of Dna Medicine

location_facility: Universitair Ziekenhuis Antwerpen (UZA) (University Hospital Antwerpen)

location_facility: Faculty Of Medicine, Osaka University Graduate School Of Medicine

location_facility: Univesitatsklinikum Tubingen Klinik fur Kinder und Jugendmedizin

location_facility: Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi

location_facility: Hospital de Cllnicas de Porto Alegre (HCPA) / UFRGS

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago


ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
Czechia
Slovakia
Hungary
Spain
United States
Canada

ipd_sharing: Yes

type: EudraCT Number

type: Other Identifier

title: A Phase II Study of Pazopanib GW786034, NSC# 737754 in Children, Adolescents and Young Adults With Refractory Solid Tumors

summary: The study design was an open-label Phase II pediatric clinical study. The purpose of Study X2203 was to identify any efficacy signal in subjects with the disease subtypes under study, when treated with pazopanib monotherapy. Furthermore, it was to define the toxicities of pazopanib in children, as well as examine biological markers, e.g. cytokines and angiogenic factors, that could help further characterize any response of pazopanib in children. Pazopanib was administered as monotherapy in tablet and powder suspension formulations at daily doses of 450 mg/m2/dose or 225 mg/m2/dose, respectively. The first 6 enrolled subjects receiving oral suspension formulation were assessed for tolerability and extended PK sampling; and, only if pazopanib was tolerated, subsequent subjects were enrolled at the same starting dose with the suspension. Dose escalation was not permitted. For the tablet, a dosing nomogram was used based on the subject's BSA. Dose reduction was dependent upon the toxicity of pazopanib and disease status of the infants, toddlers, children, adolescents, and young adults. Subjects could be as young as 1 year-old infants to screen for enrollment. Subjects were assessed for initial response after 8 weeks of treatment prior to Cycle 3. A cycle was defined as 28 days of pazopanib treatment with no rest period between cycles. Treatment was administered continuously once daily. Treatment was to be discontinued if there was evidence of disease progression, unacceptable treatment-related toxicity, pregnancy. Histological classification was an important diagnostic inclusion in these subjects with a wide variety of refractory solid tumors, i.e. 7 different tumor types and each being a cohort.


title: A Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Evaluating the Immunogenicity of FE 999049 in Repeated Cycles of Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

summary: This trial investigates the immunogenicity of FE 999049 in repeated cycles.

design_allocation: Non-Randomized

ReferenceCitation: Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13.

family: Havelock

full_name: Jon Havelock

given: Jon

family: Aaris Henningsen

full_name: Anna-Karina Aaris Henningsen

given: Anna-Karina

family: Mannaerts

full_name: Bernadette Mannaerts

given: Bernadette

family: Arce

full_name: Joan-Carles Arce

given: Joan-Carles

journal_name: Journal of Assisted Reproduction and Genetics

oa_host_type: publisher

evidence: open (via crossref license)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18.

name: School of Medicine University of Glasgow Glasgow UK

family: Nelson

full_name: Scott M. Nelson

given: Scott M.

name: Biometrics – Global Clinical R&D Ferring Pharmaceuticals Copenhagen Denmark

family: Larsson

full_name: Per Larsson

given: Per

name: Reproductive Health – Global Clinical R&D Ferring Pharmaceuticals Copenhagen Denmark

full_name: Bernadette M. J. L. Mannaerts

given: Bernadette M. J. L.

name: Fertility Clinic, Rigshospitalet Copenhagen University Hospital Copenhagen Denmark

family: Nyboe Andersen

full_name: Anders Nyboe Andersen

given: Anders

name: Emeritus Professor University of Utrecht Utrecht The Netherlands

family: Fauser

full_name: Bart C. J. M. Fauser

given: Bart C. J. M.

bso_classification: Biology (fond.)

journal_name: Clinical Endocrinology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

lead_sponsor: Ferring Pharmaceuticals

location_country:
Italy
Brazil
France
Czechia
Poland
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: Pacific Centre for Reproductive Medicine

location_facility: Rigshospitalet Fertilitetsklinikken (there may be other sites in this country)

location_facility: Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country)

location_facility: Fertilitat and PUC-RS (there may be other sites in this country)

location_facility: UZ Brussel (there may be other sites in this country)

location_facility: The nOvum Clinic (there may be other sites in this country)

location_facility: IVI Sevilla (there may be other sites in this country)

location_facility: IVF & Reproductive Genetics Center (there may be other sites in this country)

location_facility: IVF CUBE SE (there may be other sites in this country)

location_facility: Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country)

location_facility: Centro Natalità San Raffaele (there may be other sites in this country)


title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

summary: This trial investigates the effects of FE 999049 compared to GONAL-F.

ReferenceCitation: Arce JC, Larsson P, García-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.

family: García-Velasco

full_name: Juan Antonio García-Velasco

given: Juan Antonio

journal_name: Reproductive BioMedicine Online

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta

ReferenceCitation: Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2021 Sep 23. pii: S1472-6483(21)00473-9. doi: 10.1016/j.rbmo.2021.09.014. [Epub ahead of print]

family: Ishihara

full_name: Osamu Ishihara

given: Osamu

title: Comparison of ovarian response to follitropin delta in Japanese and Caucasian IVF/ICSI patients

ReferenceCitation: Nyboe Andersen A, Nelson SM, Fauser BC, García-Velasco JA, Klein BM, Arce JC; ESTHER-1 study group. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-396.e4. doi: 10.1016/j.fertnstert.2016.10.033. Epub 2016 Nov 29.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_institution: The University of Glasgow - Enlighten: Publications


title: Phase II Randomized Double Blind Placebo Controlled Trial of Combination of Pimasertib With SAR245409 or of Pimasertib With SAR245409 Placebo in Subjects With Previously Treated Unresectable Low Grade Ovarian Cancer

summary: This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.

lead_sponsor: EMD Serono

location_country:
United States
France
Poland
Belgium
Australia
Spain
Canada


title: OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib

acronym: OPTIMIS

summary: This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

lead_sponsor: Bayer

location_country:
Greece
Russian Federation
Denmark
Taiwan
India
Spain
Pakistan
France
Japan
Poland
Slovakia
Thailand
Indonesia
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Vietnam
Singapore
Hungary
China
Austria
Brazil
Mexico
Czechia
Israel
Egypt
Kazakhstan
Turkey

intervention_type: Procedure


title: A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

summary: This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety of patients is an objective throughout all parts of the study.

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15. Review.

family: Navada

full_name: Shyamala C. Navada

given: Shyamala C.

family: Silverman

full_name: Lewis R. Silverman

given: Lewis R.

journal_name: Expert Review of Anticancer Therapy

ReferenceCitation: Chaurasia, P. et al. Rigosertib in Combination with Azacitidine Modulates Epigenetic Pathways and can Overcome Clinical Resistance to Hypomethylating Agents in Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S121, April 2017; MDS 2017.

ReferenceCitation: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

ReferenceCitation: Navada S, Garcia-Manero G. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study. Blood Dec 2016, 128 (22) 3167; ASH 2016.

ReferenceCitation: Navada, S. et al. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S30, April 2017; MDS 2017.

ReferenceCitation: Navada SC, Garcia-Manero G, OdchimarReissig R, Pemmaraju N, Alvarado Y, Ohanian MN, John RB, Demakos EP, Zbyszewski PS, Maniar M, Woodman RC, Fruchtman SM, Silverman LR. Rigosertib in combination with azacitidine in patients with myelodysplastic syndromes or acute myeloid leukemia: Results of a phase 1 study. Leuk Res. 2020 Jul;94:106369. doi: 10.1016/j.leukres.2020.106369. Epub 2020 May 12.

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

family: OdchimarReissig

full_name: Rosalie OdchimarReissig

given: Rosalie

family: Pemmaraju

full_name: Naveen Pemmaraju

given: Naveen

family: Alvarado

full_name: Yesid Alvarado

given: Yesid

family: Ohanian

full_name: Maro N. Ohanian

given: Maro N.

family: John

full_name: Rosmy B. John

given: Rosmy B.

family: Demakos

full_name: Erin P. Demakos

given: Erin P.

family: Zbyszewski

full_name: Patrick S. Zbyszewski

given: Patrick S.

family: Maniar

full_name: Manoj Maniar

given: Manoj

family: Woodman

full_name: Richard C. Woodman

given: Richard C.

family: Fruchtman

full_name: Steven M. Fruchtman

given: Steven M.

journal_name: Leukemia Research

lead_sponsor: Onconova Therapeutics, Inc.

location_country:
United States
France

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: White Plains Hospital Center for Cancer Care

location_facility: Carolina Blood and Cancer Care Associates

location_facility: Desert Hematology Oncology Medical Group, Inc.


title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis

acronym: RESILIENT

summary: This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).

ReferenceCitation: Hanna MG, Badrising UA, Benveniste O, Lloyd TE, Needham M, Chinoy H, Aoki M, Machado PM, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Katsuno M, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Auberson LZ, Wu M, de Vera A, Papanicolaou DA, Amato AA; RESILIENT Study Group. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet Neurol. 2019 Sep;18(9):834-844. doi: 10.1016/S1474-4422(19)30200-5.

family: Hanna

full_name: Michael G Hanna

given: Michael G

family: Badrising

full_name: Umesh A Badrising

given: Umesh A

family: Benveniste

full_name: Olivier Benveniste

given: Olivier

family: Lloyd

full_name: Thomas E Lloyd

given: Thomas E

family: Needham

full_name: Merrilee Needham

given: Merrilee

family: Chinoy

full_name: Hector Chinoy

given: Hector

family: Aoki

full_name: Masashi Aoki

given: Masashi

family: Machado

full_name: Pedro M Machado

given: Pedro M

family: Liang

full_name: Christina Liang

given: Christina

family: Reardon

full_name: Katrina A Reardon

given: Katrina A

family: de Visser

full_name: Marianne de Visser

given: Marianne

family: Ascherman

full_name: Dana P Ascherman

given: Dana P

family: Barohn

full_name: Richard J Barohn

given: Richard J

family: Dimachkie

full_name: Mazen M Dimachkie

given: Mazen M

family: Miller

full_name: James A L Miller

given: James A L

family: Kissel

full_name: John T Kissel

given: John T

family: Oskarsson

full_name: Björn Oskarsson

given: Björn

family: Joyce

full_name: Nanette C Joyce

given: Nanette C

family: Van den Bergh

full_name: Peter Van den Bergh

given: Peter

family: Baets

full_name: Jonathan Baets

given: Jonathan

family: De Bleecker

full_name: Jan L De Bleecker

given: Jan L

family: Karam

full_name: Chafic Karam

given: Chafic

family: David

full_name: William S David

given: William S

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_institution: The University of Manchester - Research Explorer

location_country:
Italy
Switzerland
Netherlands
France
Japan
Belgium
Australia
Denmark
United States
United Kingdom


location_country:
Italy
Brazil
India
Mexico
Netherlands
Germany
France
Malaysia
Greece
Hungary
Belgium
Argentina
Spain
Turkey
United States
Colombia

location_facility: Oregon Health and Science University SOM230B2411

location_facility: University of Alabama at Birmingham The Kirklin Clinic

title: A Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's Disease

summary: The main purpose of this prospective, multicenter, open-label phase II study, was to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing's disease.


ReferenceCitation: DelBello MP, Tocco M, Pikalov A, Deng L, Goldman R. Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression. J Child Adolesc Psychopharmacol. 2021 Sep;31(7):494-503. doi: 10.1089/cap.2021.0040. Epub 2021 Jul 29.

name: Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.

family: DelBello

full_name: Melissa P. DelBello

given: Melissa P.

name: Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts, USA.

family: Tocco

full_name: Michael Tocco

given: Michael

name: Sunovion Pharmaceuticals, Inc., Fort Lee, New Jersey, USA.

family: Pikalov

full_name: Andrei Pikalov

given: Andrei

family: Deng

full_name: Ling Deng

given: Ling

family: Goldman

full_name: Robert Goldman

given: Robert

journal_name: Journal of Child and Adolescent Psychopharmacology

evidence: open (via page says license)

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

lead_sponsor: Sunovion

location_country:
Mexico
Philippines
France
Bulgaria
Malaysia
Poland
Romania
Hungary
Puerto Rico
Russian Federation
Spain
United States
Korea, Republic of
Colombia
Ukraine

location_facility: Sverdiovsk Regional Clinical Psychiatric Hospital

location_facility: Alexian Brothers Health and Wellness Center

location_facility: Regional Clinical Mental Hospital of Saint Sofiya

location_facility: Centro de Investigacion Clinica Psiquiatrica

location_facility: Instituto de Informacion de Investigacion en Salud Mental

location_facility: Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI

location_facility: University of South Florida Rothman Center of Neuropychiatry

location_facility: Family Psychiatry of The Woodlands, P.A.

location_facility: State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital"

location_facility: FSBSI "Scientific Research Institute of Mental Health"

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: CI Lviv Regional Clinical Psychiatric Hospital

location_facility: University of California San Francisco Medical Center

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: Medical Research Group of Central Florida

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

location_facility: University Hospitals Case Medical Center

location_facility: West Visayas State University Medical Center

location_facility: CI Kherson Regional Psychiatric Hospital of Kherson RC

location_facility: State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod"

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

location_facility: GUZ Lipetsk Regional psychoneurological Hospital #1

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

location_facility: Closed corporation "Scientific Center of Personalized Psychiatry"

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

location_facility: TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions

location_facility: Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: SHI "City Psychoneurological dispensary #7 (with Hospital)"

location_facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept.

location_facility: SI Institute of Children and Adolescents Healthcare of NAMSU

location_facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

location_facility: Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

location_facility: The Ohio State University Nisonger Center

title: A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

summary: This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326


publications_result: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

ReferenceCitation: Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.

family: Navada

full_name: Shyamala C. Navada

given: Shyamala C.

family: Silverman

full_name: Lewis R. Silverman

given: Lewis R.

title: The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes

location_country:
Germany
United States
France

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Anschutz Cancer Pavilion University of Colorado

location_facility: Washington Cancer Institute at Medstar Washington Hospital Center

location_facility: Greenbaum Cancer Center University of Maryland

location_facility: Hôpital Saint-Louis, Service d'Hématologie

title: A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System

summary: The study will enroll low risk MDS patients who need red blood cell transfusions and who are refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study is to determine whether oral rigosertib treatment results in hematological improvements according to the 2006 International Working Group criteria in these patients. The study will also record any side effects that may occur during the study.