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Exploring biological measures to facilitate the discovery and development of new treatments for social and cognitive deficits in Alzheimer*s disease, schizophrenia, and major depression: replication and generalisability of the Psychiatric Ratings using Intermediate Stratified Markers (PRISM)1 study

The overall goal of the PRISM programme of research is to develop a quantitative, transdiagnostic, neurobiological approach to the understanding of neuropsychiatric disorders in order to accelerate the discovery and development of better treatments…

A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286 in Subjects with Metastatic Uveal Melanoma

Primary:• To determine the safety and tolerability of FHD-286 when administered as an oral monotherapy in subjects with metastatic uveal melanoma (UM)• To identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of FHD-…

An N-of-1 double-blind randomized phase 1 trial of the safety and feasibility of (intermittent) hypoxia therapy in Parkinson*s disease

To explore the safety and feasibility of continuous and intermittent hypoxia therapy in PD and the differences of symptom modification of different hypoxia protocols. Secondary outcomes include exploring the responsiveness of subjective and…

Metabolomics in Dravet syndrome

Primary Objectives: 1. To assess the metabolic profile of patients with Dravet syndrome and identify metabolic variations that contribute to the pathophysiology of seizures and developmental delaySecondary Objectives:2. To assess the association…

A feasibility study on applying Virtual Reality EMDR as an add-on to regular trauma focused treatment in veterans with posttraumatic stress disorder

Feasibility is assessed after every VR-EMDR session and after treatment completion. PTSD symptoms, quality of life and self-empowerment are assessed before and after treatment.

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 (…

Vector Flow Imaging in healthy vessels

Primary objective:To evaluate the performance of bST and echoPIV in quantifying spatiotemporal blood flow velocity profiles in the CA and SFA of healthy volunteers in comparison to 4D flow MRI.Secondary objective:- To determine the correlation of…

A single-centre, exploratory study to characterise the skin barrier and microbiome of patients with cutaneous T-cell lymphoma (CTCL)

• To investigate the microbiome composition of the nares, non-lesional skin and patches, plaques and tumours in lesional skin of CTCL patients, including all stages of the disease• Correlate microbiome (including S. aureus presence) and disease…

Preoperative prediction of postoperative physical function, at 6 weeks, in patients with total knee arthroplasty based on physical fitness and patient characteristics; a prospective cohort study

Primary Objective: To investigate if a risk model can be made, based on physical fitness and patient characteristics, to predict the recovery of physical function 6 weeks after total knee arthroplasty.Secondary Objective(s): To explore if this model…

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, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a)
Levels Among Patients With Documented History of Atherosclerotic Cardiovascular
Disease (ASCVD)

Primary:-To identify subjects with documented history of myocardial infarction (MI) and/or percutaneous coronary intervention (PCI) and lipoprotein(a) (Lp[a]) levels >=90 mg/dL or Lp(a) >=200 nmol/LSecondary:-Evaluate the distribution…

Estimation of Energy Expenditure and Physical Activity Classification with Wearables

Primary Objective: The primary objective of this study is to develop and validate an energy expenditure estimation and physical activity classification algorithm based on wearable sensors. To do so the relevant signals contributing to the…

A Phase I, two parallel arms, open label, randomized, two period, two-way cross-over study to assess the steady-state pharmacokinetics of a 40 mg PHA-022121 XR tablet administered once daily with the steady-state pharmacokinetics of two 10 mg PHA-022121 IR capsules administered twice daily (Arm 1) and to assess the steady-state pharmacokinetics of 40 mg PHA-022121 XR tablet administered twice daily with the steady-state pharmacokinetics of four 10 mg PHA- 022121 IR capsules administered twice da

In this study we will investigate how quickly and to what extent a formulation of the study compound PHA-022121 is absorbed, transported, and eliminated from the body. There are two compositions of the study compound: one with an extended release…

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…

Bovine Osteopontin for Elderly Immune Support

Assess the percentage of responders to hepatitis B vaccination (i.e. attaining anti-hepatitis B antibody titres beyond 10 IU/L) in healthy elderly receiving a daily dose of OPN-10, compared to a placebo product.Secondary objectives:• Compare the…

A randomized, participant and investigator blinded, sponsor open-label, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in heart failure participants with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF)

To evaluate the safety and tolerability of XXB750 in adult participants with chronic stable HFrEF/HFmrEF.

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 Phase 1 Study to Assess the Mass Balance, Excretion, and Pharmacokinetics of [14C]-GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Healthy Participants

In this study we will investigate how quickly and to what extent GBT021601 is absorbed, transported, and eliminated from the body. For this study, GBT021601 is radioactively labelled with carbon-14 (14C). In this way, GBT021601 can be traced in…