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DIAN-TU-001 A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multicenter Study of Potential Disease Modifying Therapies in Individuals at Risk for and with Dominantly Inherited Alzheimer*s Disease

To assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer*s disease-causing mutation by determining if treatment with the study drug slows the rate of progression…

A Phase 1 Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB078 Administered Intrathecally to Adults with C9ORF72-Associated Amyotrophic Lateral Sclerosis

Primary objective: To study the safety and tolerability of BIIB078 in adults with C9ORF72-ALS.Secondary objective: To study the pharmacokinetics (PK) profile of BIIB078.

A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY,
PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY,
AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED
WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

This study will evaluate the safety, efficacy, and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in patients with moderate to severe ulcerative colitis (UC).

The Perioperative ADministration of Dexamethasone and Infection trial

We plan to conduct a large, pragmatic, multicentre, randomised non-inferiority trial to determine whether the use of intraoperative dexamethasone, a widely used antiemetic in perioperative medicine, is associated with an unacceptable increased risk…

SaphenoUs Nerve block Reduces length of Stay after Epiphysiodesis of the knee - a triple blind randomised superiority trial

Objective: The primary outcome objective of this trial will be length of stay in the hospital after surgery. We further will analyze intra- and postoperative opioid consumption, NRS pain scores, time in the post anesthetic care unit, time to walk (…

Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque* Injection 320 mgI/mL) on Renal Function in Adults with Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)

Primary Objective:* To demonstrate the safety of intravenous (i.v.) iodinated iso-osmolar iodixanol (Visipaque* Injection 320 mgI/mL) usage in contrast-enhanced computed tomography (CECT) for CKD stage III/IV patients by evaluating the incidence of…

A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS-986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Postive Gastric or Gastroesophageal Junction Adenocarcinoma

Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…

CE marking for the Q-whet micro current wound stimulator

Objective:The objective of the study is to test the hypothesis that the QWHET micro current wound stimulation device has minimal side effects. The study will be designed as a double blind, prospective study.The results will be used to obtain a CE…

Deferoxamine in Aneurysmal Subarachnoid Hemorrhage trial

This study investigates the safety and tolerability of deferoxamine use in patients with aneurysma subarachnoid hemorrhage.

Efficacy of ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial
(Ketamine Trial Amsterdam, KETA)

The aim of this study is to find a directly applicable intervention for acutely suicidal patients, so that the risk of these patients committing suicide is substantially lowered, leading to fewer actual suicides. To this end we propose a randomized…

Efficacy and safety of bumetanide oral liquid formulation in children aged from 2 to less than 7 years old with Autism Spectrum Disorder.
A 6-month randomised, double-blind, placebo controlled multicentre parallel group study to evaluate efficacy and safety of bumetanide 0.5mg twice a day followed by an open label active 6-month treatment period with bumetanide (0.5mg twice a day) and a 6 weeks discontinuation period after treatment stop.

The primary objective is to demonstrate the superiority of bumetanide (0.5mg BID) oral liquid formulation compared to placebo in the improvement of ASD core symptoms after 6 months of treatment in ASD children aged from 2 to less than 7 years old.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO)

Primary Objective:* To evaluate the effect of every-other-week subcutaneous (SC) administration of XmAb5871 on the time to IgG4-related disease (IgG4-RD) disease flare following an initial course of corticosteroid therapy in subjects with active…

A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)

To assess the safety and reactogenicity of HB-101.To assess the immunogenicity of HB-101.

A phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with early, oligoarticular psoriatic arthritis despite initial stable treatment with either non-steroidal anti-inflammatory drugs (NSAIDs) and/or <=1 conventional synthetic disease-modifying antirheumatic drugs (DMARD).

Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active
Ulcerative Colitis

The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely…

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled
Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24
Weeks to Participants with Heart Failure with Reduced Ejection Fraction

• To evaluate the efficacy of JTT-251 in participants with heart failure with reduced ejection fraction (HFrEF)• To evaluate the safety and tolerability of JTT-251 following administration for 24 weeks in participants with HFrEF• To evaluate the…

A randomized, double-blind, placebo-controlled, multi-centre, sequential design, phase IIa study to evaluate safety and tolerability of epicardial injections of AZD8601 during coronary artery bypass grafting surgery.

Primary Objective; To investigate safety and tolerability of AZD8601 following epicardial injection in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery with moderately impaired systolic function. In addition, exploratory objectives…