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TOLERANCE: a 3 arm randomized study on healTh-related quality Of Life of EldeRly pAtients with advaNced soft tissue sarComa undergoing doxorubicin every three weeks or doxorubicin weekly or cyclophosphamide plus predniso(lo)ne treatment

Main objectiveThe primary objective of this study is to assess whether a higher HRQoL, in terms of impact of the disease and its treatment on physical and role functioning, is achieved with metronomic schedules of doxorubicin or cyclophosphamide…

The effect of Virtual Reality on pulmonary recovery and mobility in patients with blunt chest trauma.

Primary Objective:To investigate the effect of respiratory and physical exercises in VR on pulmonary recovery compared to the standard of care of patients suffering from blunt chest trauma.Secondary Objective(s):- To investigate if VRx can improve…

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold
Agglutinin Disease (CAD)

Primary objective:- To demonstrate the efficacy of twice-weekly s.c. 1080-mg infusions of pegcetacoplan compared with that of placebo in patients with CAD.Secondary objectives:- To demonstrate the effect of pegcetacoplan on the number of PRBC…

A phase 3 study of PTC923 in subjects with phenylketonuria

Primary:• To evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria (PKU) as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (ie, the average of each respective…

A Phase 3, observer-blind, randomized, placebo controlled study to evaluate the non inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults >=60 years of age.

Primary objective:To demonstrate the non-inferiority (NI) of the humoral immune response in healthy participants 50-59 YOA compared to OA (>=60 YOA) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.To demonstrate…

A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

Primary• To evaluate the effect of CK-3773274 on exercise capacity (VO2) in patients with symptomatic oHCMSecondary• To evaluate the effect of CK-3773274 on patient health status• To evaluate the effect of CK-3773274 on New York Heart Association (…

A PHASE 3, OPEN-LABEL EXTENSION OF COURAGE-ALS (CY 5031)

To assess the long-term safety and tolerability of reldesemtiv in patients with ALS

A multicenter, international, randomized, active comparator-controlled, double-blind, doubledummy, parallel-group, 2-arm, Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor Asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke

This study has been transitioned to CTIS with ID 2023-503794-38-00 check the CTIS register for the current data. - To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic…

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

This study has been transitioned to CTIS with ID 2022-503012-16-00 check the CTIS register for the current data. To evaluate intraoperative efficacy of PROTHROMPLEX TOTAL in comparison with standard of care (SOC) 4F-PCC, for reversal of…

Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C (NPC): A Phase III, randomized, placebo-controlled, double-blind, crossover study

This study has been transitioned to CTIS with ID 2023-510278-14-00 check the CTIS register for the current data. Primary Objective:In all jurisdictions except the United States (US), the primary objective is to evaluate the efficacy of N-Acetyl-L-…

A Phase 3, Randomized, Double-Blind Trial of Two Formulations of Setmelanotide (Daily and Weekly) with a Crossover to Open-Label Once Weekly Setmelanotide in Patients with Specific Gene Defects in the Melanocortin-4 Receptor Pathway Who Are Currently on a Stable Dose of the Once Daily Formulation

Primary: To compare the pharmacokinetics (PK) of the once daily (QD) and once weekly (QW) formulations of setmelanotideSecondary Objectives:To assess the safety of the QW formulation of setmelanotide with up to 6 months (26 weeks) of drug…

A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19

To determine whether convalescent plasma collected from donors who have recovered from COVID-19 and who have a very high titre of anti-SARS-CoV-2 antibodies reduce the risk of hospitalization or death due to COVID-19 in patients with early symptoms…

The effect of virtual reality on anxiety and pain in anterior cruciate ligament reconstruction: a prospective randomized controlled trial

The aim of this study is to determine whether VR used in the pre- and postoperative period after elective orthopedic surgery will decrease pain scores.

Evaluation of adhesions formation using conventional third generation endometrial ablation with and without postoperative application of an intrauterine adhesion barrier film

Evaluate the formation of adhesions after third-generation endometrial ablation, with and without the intrauterine adhesion barrier

A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line mPDAC.This study aims to explore whether blockade of Transforming…