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NCT ID: NCT05238116 Recruiting - Refractory IPA Clinical Trials

Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)

Start date: June 14, 2022
Phase: Phase 3
Study type: Interventional

To assess the safety and efficacy of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory IPA

NCT ID: NCT05234190 Recruiting - Liver Diseases Clinical Trials

Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients

LIBERATE
Start date: January 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of liver transplant rejection following immunosuppression withdrawal. QEL-001 is a product made from a patients own cells, which are genetically modified and designed to help the transplant recipient's body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.

NCT ID: NCT05234034 Recruiting - Physical Activity Clinical Trials

Intensity of Physical Activity Level During Daily Living: Unravelling Its Relationship With Chronic Musculoskeletal Disorders and Evaluating Underlying Facilitators and Barriers, An Exploratory Survey Study

MSK-SUR
Start date: February 15, 2022
Phase:
Study type: Observational

chronic musculoskeletal disorders (CMDs) are a hugh burden to healthcare wordwide. Physical activity can improve outcomes related with CMDs, however dose response relationships are poorly understood. Therefore, to date it has not been possible to formulate general recommendations on optimal therapeutic quantity of physical activity. Furthermore, a complexity of possible facilitators and barriers has been stated to limit effective improvement of physical activity in therapy and currently applied low to moderate exercise intensities in rehabilitation could be below the required level to achieve optimal therapy outcomes. The primary objective of this study is to get insight on the impact of the intensity of the physical activity level on pain and disability in persons with CMDs. Second, the underlying facilitators and barriers to perform physical activity (at different intensities) during daily living will be evaluated. Third, the impact of the intensity of the physical activity level on the motivation to perform a rehabilitation program will be evaluated.

NCT ID: NCT05234008 Recruiting - Clinical trials for Chronic Low-back Pain

Technology Supported High Intensity Training at Home for Persons With Chronic Low Back Pain

HIT-HOME
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

1. Background 1.1 Introduction Chronic low back pain (CLBP) is the most disabling musculoskeletal disorder worldwide4. Exercise therapy can improve CLBP, but effect sizes remain modest. Recently, our research group has shown that high intensity training (HIT) is a feasible and effective therapy modality to significantly improve physical fitness and reduce functional disability in comparison to moderate intensity training in persons with moderately disabling CLBP9. However, persons with CLBP often do not continue exercising after discharge, which can lead to a decline of (long term) treatment effects. A technology supported home program, that guides the substantial effort that is necessary for further improvement, may enhance (the retention of) training effects. 1.2 Objective, research questions, and hypotheses Primary objective: To evaluate the feasibility of a technology supported HIT program performed at home in persons with CLBP. Secondary objective: To assess the clinical effectiveness of a technology supported HIT program performed at home in persons with CLBP. Research questions and hypotheses: Research question (RQ)1 - To which extent is it feasible to perform HIT at home in persons with CLBP? Hypothesis (HP)1 - A high intensity training program performed at home by persons with CLBP is feasible, conceptualized by retained or improved participant motivation, high therapy adherence, and absence of adverse events. RQ2 - To which extent is it feasible to use Physitrack as a supportive technology application during HIT at home in persons with CLBP? HP2 - It is feasible to use Physitrack to support persons with CLBP that perform a HIT program at home (i.e. provide information concerning the exercise program and provide feedback), conceptualized by an evaluation of the Physitrack application on the usability score of 'above average'. RQ3 - To which extent is a technology supported HIT program an effective therapy modality to treat persons with CLBP? HP3: A technology supported HIT program is an effective therapy modality to treat persons with CLBP, conceptualized by a significant increase in physical fitness, and decrease in pain intensity and functional disability.

NCT ID: NCT05233137 Recruiting - COPD Exacerbation Clinical Trials

Enhancing Muscle Function After Exacerbations of COPD to Limit Its Impact on Physical Activity Decline

Start date: February 8, 2022
Phase: N/A
Study type: Interventional

Patients with COPD lose muscle strength during acute exacerbations of COPD (AECOPD) which interferes improving the recovery of physical activity (PA) after an AECOPD. Resistance training can reverse this process. An exercise training program with the focus on resistance training is essential in minimizing the long-term effects of AECOPD as it may help to accelerate the gain in PA in the weeks after an acute event. Therefore, it is important that such programs are embedded at the right moment (i.e. immediately after an AECOPD) and in a setting accessible to the patient (i.e. primary care). The efficacy and effectiveness of implementing such training programs will be assessed in the present study.

NCT ID: NCT05230745 Recruiting - Clinical trials for Heart Failure, Left Sided

ContraBandâ„¢: FIH Safety & Feasibility Study (RM-20-01)

Start date: October 7, 2021
Phase: N/A
Study type: Interventional

The ContraBandâ„¢ device is intended for treatment of heart failure patients who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy. ContraBandâ„¢ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries, causing a local reduction in the internal diameters of these arteries, and resulting in an elevation in systolic right ventricular pressure. This may result in repositioning the interventricular septum to a more normal anatomical position, and supporting it with a "counter-pressure" during systole of the left ventricle. This study is a first-in-human, early feasibility, multi center, prospective, interventional, open-label, single-arm study.

NCT ID: NCT05230368 Recruiting - Clinical trials for HIV-1-infection, Subtype b

Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load

SYNACTHIV
Start date: December 14, 2022
Phase: Phase 1
Study type: Interventional

The ANRS 171 SYNACTHIV trial is an international multicenter pilot open label phase I trial. This trial will evaluate new procedures in LRA administration in 3 successive cohorts. In case of grade 3 to grade 5 adverse events, the inclusions and treatments will be (but not in a definitive manner) discontinued until the DSMB will conclude that the event was unrelated. Enrolment in cohort 2 then in cohort 3 will start only if no clinical grade 3 to grade 5 adverse event related to the LRAs occurs in the previous cohort.

NCT ID: NCT05227287 Recruiting - Clinical trials for Autosomal Dominant Hypocalcemia

ADH1 and ADH2 Disease Monitoring Study (DMS)

CLARIFY
Start date: January 20, 2022
Phase:
Study type: Observational

A global, multi-center, Disease Monitoring Study (DMS) in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1) or Autosomal Dominant Hypocalcemia Type 2 (ADH2) designed to characterize ADH1 and ADH2 disease presentation and progression through retrospective (past) and longitudinal prospective (over time into the future) data collection.

NCT ID: NCT05226182 Recruiting - Type 2 Diabetes Clinical Trials

Visualisation of a Digital Care Pathway.

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

As part of the EFRO (Europees Fonds Regionale Ontwikkeling) 1302 project "Digital Care Support in Practice with Limburg as a Stepping Stone for Flanders", this study aims to evaluate the concept and added value of visualising a personal digital care pathway for patients with type 2 diabetes. Firstly, this chronological visualisation of data strives to improve patient experience and empowerment by offering educational articles and personal medical data relevant to their care path in one place. This way, patients will have more insight in the pathogenesis, treatments, complications and goals, allowing the patients to optimize their selfcare and become confident in dealing with their chronic condition. From time to time, patients will also be asked to complete questionnaires concerning their experiences (PREM) to aid healthcare professionals in personalizing treatment goals. Secondly, the healthcare providers and caregivers surrounding the patient will also have access to the same data, allowing for a more personal approach as well as means to communicate with other members of the care team.

NCT ID: NCT05220709 Recruiting - Children, Only Clinical Trials

Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study)

Start date: April 5, 2022
Phase: N/A
Study type: Interventional

The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.