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A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps (study 205687, SYNAPSE)

Primary:To evaluate the efficacy of 100mg mepolizumab compared to placebo.Secondary:The impact on actual nasal surgery. Further efficacy assessment. Quality of life.

An Open-label Trial Investigating the Association Between Nocturia Symptoms and Sleep During 12 Weeks of Treatment with desmopressin ODT for Nocturia due to Nocturnal Polyuria in Adults

Primary Objective* To assess the association between changes in the number of nocturnal voids and change in Nocturia Sleep Quality Scale (NSQS) total score in adult subjects with nocturia due to Nocturnal Polyuria (NP)Secondary Objectives* To assess…

Efficacy of rituximab in comparison to continued corticosteroid treatment in idiopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisone.

To evalute the efficacy of rituximab in comparison to continued corticosteroid treatment in ipatients with diopathic nephrotic syndrome unresponsive to 8 weeks of high dose prednisolone.

PROGRESSIVE ESOPHAGEAL DILATION FOR BENIGN STRICTURES: A RANDOMIZED CONTROLLED TRIAL

The main objective is to compare the efficacy and safety of esophageal dilation with the balloon the Savary bougie dilator according to the rule-of-3 to rule-of > 3 strategy during 6 months in patients with a severe benign esophageal…

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)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with advanced/…

Effects of Modafinil and Caffeine on vigilance in low, medium and high caffeine consumers during the circadian trough in healthy RNLAF aircrew: a randomized controlled trial

To investigate the effect of modafinil (200 mg) and caffeine (300 mg) on vigilance in low, medium and high caffeine consumers during the circadian trough in order to determine the best pharmacological agent to target fatigue.

A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:•LDL-C levels at Day 510•Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levels. The secondary objectives of this study…

A PHASE III/IV, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) TO INVESTIGATE LONG-TERM SAFETY AND EFFICACY IN PREVIOUSLY-TREATED PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (TAIL)

This study will evaluate the long-term safety and efficacy of atezolizumab in patients with locally advanced or metastatic NSCLC who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy…

The PACE NOW Trial: A Prospective, rAndomized Comparison of tEmporary transvenous pacing and leadless paciNg therapy in pOst-TAVI patients With conduction abnormalities

The primary objective of the study is to outline the advantages of LP implantation in TAVI patients who require temporary, and possibly permanent pacing compared to the Standard of Care using TV-TP therapy. We will study whether placement of a LP…

A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) or Placebo in Participants with Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with cisplatin-…

A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with Atherosclerotic cardiovascular disease (ASCVD) or ASCVD- risk equivalents and elevated low density lipoprotein cholesterol (LDL-C)

The primary objective of this study is to evaluate the effect of inclisiran treatment on:*LDL-C levels at Day 510*Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 540 levelsThe secondary objectives of this study are…

Venlafaxine for prevention of oxaliplatin-induced peripheral neuropathy - A randomised clinical trial

Given the significant number of patients with OIPN and the possible prophylactic properties of venlafaxine, this study is designed. This study will consist of a randomised placebo-controlled clinical trial to study the prophylactic effect of…

Utilizing Novel dipole density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)

The objective of the clinical study is to evaluate the incidence of device- and procedure-related safety, efficacy, and efficiency (6-and 12-month outcomes) when using the AcQMap as an imaging and mapping system for ablation of persistent atrial…

STATEC: A randomised trial of non-selective versus selective adjuvant therapy in high risk apparent stage I endometrial cancer

To determine the clinical effectiveness of adjuvant therapy given to all unstaged (no lymph node dissection) high risk stage 1 endometrial cancer, compared with only node positive (staged) cases as judged by fulllymph node dissection.

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study with an Open-Label Period to Evaluate the Efficacy and Safety of Fremanezumab for the Prophylactic Treatment of Migraine in Patients with Inadequate Response to Prior Preventive Treatments

The primary objective of the study is to demonstrate the efficacy of fremanezumab administered as monthly and quarterly subcutaneous (sc) injections to adult patients with migraine with inadequate response to 2 to 4 classes of prior preventive…

GRAVITAS-301: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus Host Disease

Primary objective: Compare the efficacy of itacitinib in combination with corticosteroids versus placebo in combination with corticosteroids in terms of overall response rate (ORR) at Day 28 in subjects with aGVHD.Secondary objectives:- Compare the…

INTense Exercise foR surVivAL among men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC): A Multicentre, Randomised, Controlled, Phase III Study

Primary Objective is to determine if high intensity aerobic and resistance training plus psychosocial support increases overall survival compared to psychosocial support alone in patients with metastatic castrate-resistant prostate cancer.

A SINGLE-ARM, MULTICENTER PHASE IIIB CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF PROPHYLACTIC EMICIZUMAB IN HEMOPHILIA A PATIENTS WITH INHIBITORS

The study will investigate the safety and efficacy of emicizumab in patients with hemophilia A with inhibitors against FVIII.

A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures

Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…

FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown Treatment

To demonstrate non-inferiority of oral fosfomycin-trometamol compared to oral ciprofloxacin as a step-down treatment for E.coli AF-UTI in women for the cumulative incidence of survival and clinical cure (resolution of symptoms) 6-10 days post-…