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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 randomised controlled trial comparing FECal Microbiota Transplantation after BUDesonide or placebo induction in patients with ulcerative colitis; the FECBUD trial

To study the effect size of FMT after a 3 weeks course of budesonide as induction therapy in patients with active ulcerative colitis despite previous therapy. The purpose of the pre-treatment is to reduce active inflammation prior to donor feces…

A multicenter, randomized, open-label, active-controlled, dose-range finding study to assess the pharmacodynamic parameters, safety and tolerability of MAA868 and its effect on thrombogenesis biomarkers compared to apixaban in patients with atrial fibrillation

The primary objective of this study is to evaluate the proportion of patients achieving FXI inhibition * 80% at trough (Day 91) after monthly dosing at 3 dose levels of MAA868.

A randomised, double-blind, parallel group, equivalence, multicentre phase III trial to compare the efficacy, safety and pharmacokinetics of HD201 to
Herceptin® in patients with HER2+ early breast cancer.

The primary objective of this study is to show equivalence of the total pathological complete response rate (tpCR) in patients treated withHD201 plus chemotherapy to that in patients treated with Herceptin® plus chemotherapy. tpCR will be assessed…

A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX

1.3. Study Design Rationale The ATLAS-INH trial (ALN-AT3SC-003) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with haemophilia A or B with inhibitory…

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.

CALM-2 - Controlling and Lowering Blood Pressure with the MobiusHD*

To determine the safety of the MobiusHD System and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ambulatory blood pressure in subjects with resistant hypertension. The hypothesis is that mean systolic 24-hour ambulatory blood…

Training immune functions through pharmacotherapeutic conditioning in
juvenile idiopathic arthritis

This study*s objective is to reduce MTX related side effects with pharmacotherapeutic conditioning, by using variable reinforcement principles in patients with JIA. Pharmacotherapeutic conditioning enables to alternate standard MTX dosing with lower…

Removal of indwelling urinary catheter after vaginal prolapse surgery; removal on first night versus first morning after surgery.

Primary objective: Does removal of an IUC late at night on the day of vaginal prolapse surgery lead to a decrease in clinical UTIs in the first six weeks after surgery compared to removal on the morning of the first day after surgery?Secondary…

Study protocol for a randomised clinical trial comparing TREPP versus Lichtenstein*s technique in Inguinal hernia patients

To asses the hypothesis that chronic postoperative inguinal pain occurs less in patients treated with the TREPP technique

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.

Optimal blood pressure control through improved adherence to antihypertensive medication after shared decision making in people with type 2 diabetes (T2DM)

To improve BP control and health related quality of life by offering a nurse-led patient-centred supportive intervention to people with T2DM who are objectively non-adherent to their antihypertensive medication and/or life style behaviour…

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.

Protein intake in patients with colorectal or lung cancer during first line treatment with chemo(radio)- or immunotherapy when receiving a low volume, energy dense and high protein oral nutritional supplement: a randomized, controlled study

The primary study objective is to assess protein intake at the end of the first treatment cycle in patients with CRC or NSCLC undergoing first line treatment with chemo-, concurrent chemoradio- or immunotherapy who are receiving two servings of test…