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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…

Hyperbaric Oxygen Therapy Induced Neuroplasticity in Post Stroke Patients Suffering Chronic Neurological Deficiencies

Effect of hyperbaric oxygen therapy (HBOT) on patients with chronic neurological deficiency due to stroke.

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica

Primary:-To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared…

Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity who have reached target dose during run-in period

Primary objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity who have reached target dose of…

A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 >=50%

The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet…

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…

PROphylactic Mesh to prevent Incisional hernias at the former Stoma Site: the PROMISS-trial

To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh placement compared to no mesh placement. Secondly the incidence of parastomal hernias will be recorded and complications caused by preventive mesh placement…

Safety and Efficacy of turoctocog alfa pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients with Severe Haemophilia A

Primary objective:To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.Secondary objectives:To…

PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS

Primary Objective:The primary objective of this study is to provide confirmatory data on the beneficial effect of 2.0 g/kg of Octagam 10% given every 4 weeks compared with placebo in subjects with active DM based on the percentage of responders at…

TArget-Site Concentrations of prophylactic cefazolin in foot and Ankle surgery

To analyze the difference in fT>MIC at the target site and infection rate for a single dose of 1 and 2g of cefazolin.

BioXmark liquid fiducial markers for image guided radiotherapy in bladder cancer, a safety and performance trial

This study will evaluate usability, safety and performance of a cystoscopic guided injection of a marker (BioXmark) at the tumor site in patients with bladder cancer on planning CT and CBCT during the irradiation period.

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection who Are at Risk of Developing Complications

The primary objective is to evaluate superiority of pimodivir (Pi) in combination with standard-of-care (SOC) treatment (tmt) compared toplacebo in combination with SOC treatment, with respect to the time to resolution of influenza-related symptoms.

Improving propulsion of the paretic leg in chronic stroke

The purpose of this study was to demonstrate that the PP can be improved in chronic stroke survivors using a newly developed, intensive training. The effect of the new training on the PP, walking velocity and mobility at home will be determined.…

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…

TAME Cardiac Arrest Trial. Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest: A Phase III Multi-Centre Randomised Controlled Trial

The primary objective of this study is to determine whether targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN).

A 24-week randomized, controlled, multicenter, open-label study to evaluate the effect of reminder notifications and motivational/adaptive messaging on treatment adherence of COPD
subjects receiving Ultibro® Breezhaler® treatment using the Concept2 inhaler for dose administration and tracking

This study will evaluate the effect of dose tracking in conjunction with reminder notificationsand motivational/adaptive messages over 24 weeks on treatment adherence behavior insubjects with COPD. The dose tracking is done by the Concept2 inhaler…

An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes

The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…

Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA)

To compare MIDP with ODP regarding radical resection rate) for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.

A multicenter, randomized, open label, efficacy assessor-blinded study of risankizumab compared to secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systematic therapy.

The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

A randomised, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroids in subjects with moderate-to-severe atopic dermatitis who are candidates for systemic therapy

Primary objective:To demonstrate that tralokinumab in combination with TCS is superior to placebo in combination with TCS in treating moderate-to-severe AD.Secondary objectives:To evaluate the efficacy of tralokinumab in combination with TCS on…