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Efficacy of repetitive transcranial magnetic stimulation in patients with medication-resistant bipolar depression. A multicenter, randomized, double-blind, sham-controlled study

Objective: We want to determine the effectiveness of rTMS in patients with bipolar depression who did not respond to two or more adequately dosed medication trials, using an adequately powered pragmatic RCT. We hypothesize that active rTMS, compared…

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 in Adults Hospitalized with COVID-19

To evaluate the safety and tolerability of single ascending doses of ABBV-47D11 in subjects hospitalized with COVID-19.

Improving Care of Pregnant Women in the Netherlands by early identification of Perinatal & Maternal Risks Pregnancy Risk Flagging System Phase 2: satisfaction

To assess patient satisfaction of antenatal care perceived by (vulnerable) pregnant women and explore the user experience by (vulnerable) pregnant women and HCPs (healthcare professionals working in antenatal care) while using the app for real time…

Pilot validation study of IMU and markerless method for head and trunk kinematics

The primary objective of this research was to validate head and trunk kinematics calculated from IMU and markerless motion tracking systems against a gold-standard marker-based optical motion capture system (Vicon).

Self-management as a first-line treatment prior to GP consultation for men with lower urinary tract symptoms

To assess the effectiveness and cost-effectiveness of providing an online personalized self-management program as a first-lineintervention to men with lower urinary tract symptoms (LUTS) compared to care as usual (CAU).

The effect of (chemo- or bio)radiation on functional capacity, fatigue and quality of life in patients with head and neck cancer: a trial within cohorts, the VITAL study.

Primary Objective: - To determine and compare physical performance in patients with HNC with and without an exercise intervention.Secondary Objective(s): - To determine and compare muscle strength in patients with HNC with and without an exercise…

Elektrical Direct Stimulation of Peripheral Nerves to enhance Regeneration - Safety & Feasibility

The primary objective of the present study is to explore the safety and feasibility of electrical stimulation in patients with diverse kinds of nerve lesions. The secondary objective is to make a reasonable estimation of clinical effect size, which…

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)

Sub-study APhase 1b:To assess the DLT rate and estimate the MTD of sasanlimab in combination with encorafenib and binimetinib to determine the RP2D for the combination. Phase 2:To assess the durable ORR of sasanlimab in combination with encorafenib…

Evolving to an integrated smart self-assessment *Fatigability in Outcomes to monitor Resilience Targets in Older persons* (FORTO) measurement & monitoring platform.

This study aims to evaluate the predictive ability of the muscle fatiguability test to predict recovery in older adults admitted to the department of geriatric medicine. Recovery is defined as length of stay, daily functioning after 3 and 6 months…

A multi-center, pivotal, non-randomized, prospective, open-label study to evaluate the safety and performance of the Hy2Care Injectable Hydrogel for the repair of cartilage defects in the knee.

Primary objectives:Safety:To demonstrate the safety of the investigational device in 10 subjects at 3 months post-surgery.Safety cohort data will be pooled with the performance cohort data, to measure the performance and safety of the…

A multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema

The primary objective of this study is to evaluate the efficacy of SC administration of CSL312 as prophylaxis to prevent HAE attacks in subjects with HAE.The secondary objectives of the study are:1. To characterize the clinical efficacy of SC CSL312…

An open label, single arm study to evaluate single and multiple dose pharmacokinetics, safety and tolerability, and to explore clinical outcomes of treatment with intravenous |(IV) zanamivir in neonates and infants under 6 months of age with confirmed complicated influenza infection

PrimaryTo characterise the single and multiple dose to steady state pharmacokinetics of IV zanamivirin hospitalised neonates and infants under 6 months of age with influenza infection.SecondaryTo evaluate the safety and tolerability of IV zanamivir…

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Orally Administered Dapansutrile Capsules for the Treatment of Moderate COVID-19 Symptoms and Evidence of Early Cytokine Release Syndrome

The primary objective is to assess the clinical efficacy of dapansutrile versus placebo in subjects presenting with moderate COVID-19 respiratory symptoms and evidence of early cytokine release syndrome.Secondary objectives are to assess:* Complete…

The effectiveness of spaced versus massed alcohol avoidance training in inpatient alcohol use disorder treatment: A multisite randomized trial

Although the optimum length of alcohol avoidance training has been studied, little is known about the impact of the distribution of these sessions over time. As a result no guidelines or recommendations exist on whether AAT sessions should be spaced…

A two-center, randomized, double-blind, placebo-controlled, phase Ib study to assess the safety, tolerability and immunogenicity of two ascending doses of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects

• To investigate the safety and tolerability of two ascending dose levels and two different dosing intervals of the candidate vaccine MVA-MERS-S_DF-1 in healthy study subjects.• To investigate safety and tolerability of three intramuscular dose…

Response and Toxicity Prediction by Microbiome analysis in locally advanced NSCLC treated with IO (durvalumab) after Chemoradiotherapy (sequential and concurrent)

The predictive value of the microbiome (throat swabs and stool samples) to identify patients who will relapse during durvalumab treatment after CRT (False negative Rate) at 6 months. Exploratory endpoints include the effects of antibiotic therapy…

The temporal cellular landscape of the adaptive immune system in patients with acute stroke

1. To either confirm or refute the hypothesis that a subset of brain regulatory T cells exists in humans and expands after stroke.2. To identify immunological biomarkers that can be used in stroke clinical trials targeting the adaptive immune system…

A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)
NOTE: Official Title should have no more than 240 characters

Primary Objectives:- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in all randomized patients based on PFS (per RECIST 1.1 as assessed by BICR)- To assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in…

TORBO: Research in Twente on Recurrences after Pelvic Organ Prolapse Surgery

Objective: This protocol describes a framework that will be used to create different studies. The general primary and secondary objectives of this protocol are stated below:Primary objective: Investigate the effect of surgery on the position and…

Shoulder instability Trial comparing Arthroscopic stabilization Benefits compared with Latarjet procedure Evaluation (STABLE)

Prior to large trial, we will conduct a pilot trial comparing compare arthroscopic capsuloligamentous repair vs. coracoid transfer (Latarjet procedure) on recurrent dislocation rates and functional outcomes over a 24-month period.Primary questionsWe…