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Recruiting

TMS-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants

Motor Learning

The general purpose of this research project is to analyze the specific role of motor imagery on motor learning, assessed through corticospinal excitability measurements and behavioral data collection. This project is based on four sequences. For Sequence 1, the main objective is to examine the effect of mental training on movement speed and accuracy in a manual motor sequence task, as well as the influence of sensory feedback in immediate post-test (i.e., execution of a similar, but not identical, manual motor sequence, other manual tasks) on performance in delayed post-test. The secondary objective will be to examine corticospinal changes (i.e., amplitude of motor evoked potentials) induced by mental training, by measuring the amplitude of motor evoked potentials before and after mental training. For Sequence 2, the main objective is to examine the impact of a motor disturbance induced by a robotic arm at different intervals during the motor imagery process. The secondary objective will be to examine the corticospinal changes (i.e. amplitude of evoked motor potentials) induced by mental training as a function of the applied perturbations, before and after perturbation. For Sequence 3, the main objective will be to examine the influence of neuroplasticity on the quality of mental training. More specifically, the investigators will study the links between brain plasticity and motor learning through mental training. The secondary objective will be to examine the corticospinal changes (i.e. amplitude of evoked motor potentials) induced by mental training at different levels of the neuromuscular system (cortical, cervicomedullar, peripheral) after a training period. For Sequence 4, the main objective will be to examine the effect of short-term arm-immobilization of on the retention of motor learning induced by mental training. The secondary objective will be to examine the corticospinal changes (i.e., amplitude of motor evoked potentials) induced by of short-term arm-immobilization, or by transcranial direct current stimulation (tDCS), on motor learning. The results of this fundamental research project will allow a better understanding of neurophysiological and behavioral mechanisms that underlie motor learning through motor imagery. The results will allow to efficiently consider inter-individual specificities and will thus open up to clinical research perspectives, towards the establishment of adapted motor rehabilitation protocols.

Начало: 08.04.2024 Край: 01.04.2029 Възраст: 18–60 г.

France Institut National de la Santé Et de la Recherche Médica NCT04784832

Recruiting Phase 1/2

An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency

Ornithine Transcarbamylase Deficiency Ornithine Transcarbamylase Deficiency Disease Ornithine Carbamoyltransferase Deficiency (Disorder) Urea Cycle Disorders, Inborn

Ornithine Transcarbamylase (OTC) deficiency, the most common urea cycle disorder, is an inherited metabolic disorder caused by a genetic defect in a liver enzyme responsible for detoxifying of ammonia. Individuals with OTC deficiency can develop elevated levels of ammonia in the blood, potentially resulting in severe consequences, including cumulative and irreversible neurological damage, coma, and death. The most severe form presents shortly after birth and occurs more commonly in boys than girls. This is a Phase 1/2/3, open-label, multicenter study evaluating the safety, efficacy, and dose of ECUR-506 in male babies with neonatal-onset OTC deficiency. The primary objective is to evaluate the safety, tolerability, and efficacy of up to three dose levels of ECUR-506 following intravenous (IV) administration of a single dose.

Начало: 08.04.2024 Край: 01.12.2027 Възраст: 24–7 г. Treatment

Australia, Spain, United Kingdom +1 iECURE, Inc. NCT06255782

Recruiting Phase 1

A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects

Healthy Volunteers

The purpose of Part 1 is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening. The purpose of Part 2 is to assess the safety, tolerability, PK and efficacy of SAD of SC administered FB1003 in adult subjects with osteoarthritis (OA) pain.

Начало: 07.04.2024 Край: 30.05.2026 Възраст: 18–75 г. Treatment

Australia 4B Technologies Limited NCT06343714

Recruiting Phase 4

Empagliflozin Treatment in Kidney Transplant Recipients

Kidney Transplant Chronic Kidney Disease

Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.

Начало: 05.04.2024 Край: 31.03.2030 Възраст: от 19 г.

United States VA Office of Research and Development NCT06013865

Recruiting

AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Aortic Aneurysm, Abdominal

To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

Начало: 05.04.2024 Край: 01.06.2031 Възраст: от 18 г. Treatment

France, Netherlands, New Zealand +2 Shape Memory Medical, Inc. NCT06029660

Recruiting Phase 1/2

Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne

Acne

The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to three dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of a Sentinel Cohort A paired with a Main Cohort, evaluating the safety and efficacy of the 2-administration regimen and a Sentinel Cohort B, evaluating the safety of the 3- administration regimen. The Sentinel Cohorts will assess the safety of the dose levels and regimens in a stepwise manner. If the participants consent to the LTE, they will be followed up for an additional 30 months after the last planned visit in the Core Study, to assess the long-term effects of the vaccine.

Начало: 05.04.2024 Край: 31.08.2028 Възраст: 18–45 г. Treatment

Australia, Canada, United States Sanofi Pasteur, a Sanofi Company NCT06316297

Recruiting

Transpulmonary Pressure - Guided Mechanical Ventilation in Morbidly Obese ARDS Patients: a Feasibility Study.

ARDS, Human Obesity, Morbid

The goal of this clinical trial is to test a personalized intervention aiming to optimize the mechanical ventilator settings in morbidly obese patients suffering from moderate to severe Acute Respiratory Distress Syndrome (ARDS). The intervention consists of personalized measurements and calculations of the different pressures inside the thorax. The main question to answer is: • Will the evaluated esophageal pressure-guided strategy lead to different mechanical ventilator settings than suggested by a strategy largely used in ARDS patients in France? A specific nasogastric probe permitting to measure esophageal pressure will monitor participants. Esophageal pressure will act as an indicator of the pleural pressure. Other respiratory signals displayed by the mechanical ventilators will also be acquired. Further, ventilator settings will be adjusted to the evaluated esophageal pressure-guided strategy, with possible benefit of this personalized approach.

Начало: 04.04.2024 Край: 04.07.2027 Възраст: от 18 г.

France Assistance Publique - Hôpitaux de Paris NCT06119516

Recruiting

Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

Hiv Tobacco Use

Cigarette smoking is now the leading killer of people with HIV (PWH) in the US, and most cessation strategies tried to date have failed to increase long-term quit rates. An "all or none" approach to smoking cessation in PWH offers little benefit to the large majority of PWH who are unable or unwilling to quit. In this proposal we argue that a harm reduction approach (i.e., cut down, get screened for lung cancer, control your blood pressure and cholesterol) has the potential to yield significant benefits in terms of the private and public health of PWH in the US.

Начало: 04.04.2024 Край: 01.03.2027 Възраст: 40–79 г.

United States Montefiore Medical Center NCT05642715

Recruiting

iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH

Pulmonary Hypertension

Children with pulmonary hypertension (PH) engage in less physical activity than their peers. This is a concern since adult data support exercise as a non-pharmacologic treatment for PH. Despite adult data, therapeutic exercise has not been widely adopted in pediatric PH. Investigators have previously demonstrated that children with PH have less skeletal muscle mass in association with worse exercise performance. Interventions to increase physical activity and skeletal muscle mass may improve exercise performance and quality of life in children with PH. This study will use wearable activity monitoring devices to promote physical activity in a 16-week pilot intervention in children and teenager with PH.

Начало: 03.04.2024 Край: 31.12.2026 Възраст: 8–18 г.

United States Children's Hospital of Philadelphia NCT05442671

Recruiting

Image Enhanced Endoscopy IBD

Inflammatory Bowel Diseases Dysplasia

Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.

Начало: 03.04.2024 Край: 01.03.2026 Възраст: 18–75 г. Diagnostic

Australia Royal Perth Hospital NCT06266104

Recruiting Phase 1

A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy

Non-Muscle-Invasive Bladder Cancer (NMIBC)

This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.

Начало: 03.04.2024 Край: 31.08.2028 Възраст: 18–75 г. Treatment

Australia Ractigen Therapeutics. NCT06351904

Recruiting Phase 3

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

Non Small Cell Lung Cancer

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Начало: 03.04.2024 Край: 23.10.2034 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +26 Merck Sharp & Dohme LLC NCT06312137

Recruiting Phase 2

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

Pulmonary Fibrosis Progressive Pulmonary Fibrosis Pulmonary Fibrosis Secondary to Systemic Sclerosis Pulmonary Fibrosis, Interstitial Lung Disease +6

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

Начало: 03.04.2024 Край: 01.06.2027 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +11 Avalyn Pharma Inc. NCT06329401

Recruiting

Biomarkers Research in Anxiety for Validation and Efficacy

Autism Autism Spectrum Disorder

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

Начало: 02.04.2024 Край: 01.08.2026 Възраст: 3–6 г.

United States Boston Children's Hospital NCT06221176

Recruiting

Cross Modal Correlation of EEG and MRI Functional Connectivity: An Investigative Study

MRI, Functional MRI

Cross modal correlation of EEG and MRI functional connectivity: An Investigative Study. Correlating EEG Analysis with Brain Network Connectivity in Functional MRI. The primary aim of this study is to correlate correlation of MRI and EEG.

Начало: 02.04.2024 Край: 31.01.2030 Възраст: от 18 г.

Israel Assaf-Harofeh Medical Center NCT07539506

Recruiting

Does Position Influence the Diagnosis of Detrusor Overactivity in a Neurological Population

Urodynamic Exam Neurologic Disorder

ICS (International Continence Society) recommendations published in 2017 recommend performing urodynamic examinations in the sitting or standing position. These recommendations are based on a review of the literature published in 2008, which has several limitations: heterogeneous populations, old and non-harmonized techniques, and very few neurological patients. It seems appropriate to focus on neurological patients and to examine the influence of position on the detection of detrusor overactivity in these patients. The point here is to reexamine the ICS recommendations, which are not designed for neurological patients. Indeed, many patients suffering from Multiple Sclerosis (MS) or Parkinson's disease are unable to sit or stand for the duration of the urodynamic examination. The investigators would like to assess whether exploring sphincter disorders in the supine position is still interpretable. This would enable us to define ICS good practice recommendations for a neurological population.

Начало: 02.04.2024 Край: 02.04.2027 Възраст: от 18 г.

France Assistance Publique - Hôpitaux de Paris NCT05949567

Recruiting

Comparative Evaluation of Preoperative Preparation Methods in Patients With Large Incisional Hernias

Incisional Hernia Repair Ventral Hernia Repair

Patients with large, complex, or giant incisional hernias often require advanced preoperative optimization to facilitate safe abdominal wall reconstruction and reduce postoperative complications. Several strategies are currently used in clinical practice, including botulinum toxin A injection, progressive preoperative pneumoperitoneum, and their combination. However, the optimal differentiated approach based on hernia characteristics and abdominal wall tissue deficiency remains unclear. This study aims to compare the effectiveness and safety of different preoperative preparation strategies in patients with large postoperative ventral hernias and loss of abdominal wall domain. Outcomes of patients receiving botulinum toxin A, progressive preoperative pneumoperitoneum, combined preparation, or no specific preparation will be analyzed. The study will evaluate operative feasibility, ability to achieve fascial closure, postoperative complications, recurrence, and overall treatment outcomes.

Начало: 01.04.2024 Край: 01.05.2028 Възраст: от 18 г.

Russia State Budget Public Health Institution Scientific Resea NCT07549113

Recruiting Phase 4

Dupilumab De-escalation in Pediatric Atopic Dermatitis

Atopic Dermatitis

This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD) control on dupilumab.

Начало: 01.04.2024 Край: 30.04.2027 Възраст: 1–17 г.

United States Johns Hopkins University NCT06116526

Recruiting Phase 1/2

A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection

Cystic Fibrosis Lung Respiratory Infections, Recurrent, Chronic Pseudomonas Aeruginosa

A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.

Начало: 01.04.2024 Край: 01.06.2026 Възраст: от 12 г. Treatment

Australia, United States Respirion Pharmaceuticals Pty Ltd NCT06016088

Recruiting Phase 1

Microelectrode Recordings From the Vagus Nerve in Awake Humans

Epilepsy

This Anchillary project uses a refined technique of ultrasound-guided microneurography of the human cervical vagus nerve, an approach developed by Professor Vaughan Macefield and used safely to-date in 44 prior study participants. The overall goal of this project is to build upon prior data obtained using this approach by undertaking a detailed neurophysiological investigation of the human vagus nerve and to identify the nerve fibers activated during vagal nerve stimulation (VNS) in participants with implanted VNS devices in response to different stimulation parameters. In addition to providing data in unprecedented detail into the physiology of the human vagus nerve, this project will investigate different stimulus intensities, durations and frequencies that differentially excite myelinated and unmyelinated nerve fibers. These results will inform the CSP and guide future development of novel neural interfaces for VNS for various clinical applications.

Начало: 01.04.2024 Край: 31.12.2026 Възраст: 18–40 г.

United States University of Minnesota NCT06016686

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