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NCT ID: NCT06446427 Not yet recruiting - Risk Reduction Clinical Trials

The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Rescue services in mountainous regions are frequently called to missions at altitudes >3000 m. Under the difficult conditions of acute exposure to altitude, the crews then have to undertake demanding medical and rescue measures. Previous studies in non-medical personnel, such as astronauts, aircraft pilots, and military helicopter pilots have found that the lack of oxygen associated with acute exposure to altitude may impair cognitive functions. No data exists on the effect this may have on the performance of medical staff in terms of patient examination, communication, decision-making, planning, and overall patient care. This study aims to close this knowledge gap. The investigators of this study aim to make rescue missions to high altitude safer for both the patients and the rescuers. To assess the effect of high altitude on patient care, the investigators recruit highly trained medical specialists who will perform patient care in simulated scenarios both at high altitude and at low altitude. These scenarios will be recorded and the performance of the medical specialists judged by independent reviewers. The medical specialists will also perform in simulated scenarios at high altitude two more times: once with supplementary oxygen, and once after spending a night at high altitude. the investigators do this to evaluate whether supplementary oxygen improves their performance, and whether symptoms of acute mountain sickness (which usually develop after spending the first night at high altitude) decreases their performance further.

NCT ID: NCT06443216 Not yet recruiting - Healthy Clinical Trials

Sleep Modulation to Treat Depression

Start date: June 2024
Phase: N/A
Study type: Interventional

Current first-line treatments for major depression (antidepressants and psychotherapy) show a long latency to response, and less than half of all patients experience full remission with optimized treatment, indicating the need for new developments. The aim of this study is to extend and further develop a longstanding line of research of using sleep neurophysiology as a 'window to the brain' and treatment development in major depression. Particularly, this project is designed to test the feasibility, efficacy and mechanisms of action of a new sleep-based treatment technology.

NCT ID: NCT06435858 Not yet recruiting - Clinical trials for Autosomal Dominant Polycystic Kidney Disease

Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease

SIDIA
Start date: September 1, 2024
Phase: Phase 4
Study type: Interventional

This study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the SGLT2 inhibitor Empagliflozin. Patients will be randomized into two groups and take Empagliflozin or a Placebo for 2 weeks with a wash-out period of 2 weeks. The primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. Secondary outcomes include diuresis, safety and tolerability.

NCT ID: NCT06431971 Not yet recruiting - Parkinson Disease Clinical Trials

Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This study is double-blinded placebo controlled to estimate the short-term efficacy of Talineuren. The investigational Medicinal Product (IMP) is administrated 18 times intravenously as an add-on therapy to the standard of care Parkinson medication. Talineuren is a liposomal formulation containing GM1 (monosialotetrahexosylganglioside) as the pharmacological active substance. The results of this pilot study are essential for the sample size calculation of a subsequent larger phase II/III trial.

NCT ID: NCT06430736 Not yet recruiting - Lymphoma Clinical Trials

PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab)

PRONTO
Start date: June 2024
Phase: Phase 2
Study type: Interventional

Despite the consequent use of Tocilizumab together with conventional antipyretics at early/first signs of emerging CRS, CRS (and eventually the subsequent development of ICANS) remain a major concern for patients. This study aims to identify safety and efficacy of prophylactic Tocilizumab treatment. In particular, to explore whether prophylactic Tocilizumab treatment can decrease the incidence and severity of CRS (and subsequent eventual neurotoxicity) following CAR-T-treatment.

NCT ID: NCT06426576 Not yet recruiting - Surgery Clinical Trials

Load Limits After Orthopaedic Surgery: Biofeedback vs. Conventional Method (AppPWB)

Start date: March 2025
Phase: N/A
Study type: Interventional

The aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method.

NCT ID: NCT06422884 Not yet recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

Start date: September 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in these patient populations.

NCT ID: NCT06420596 Not yet recruiting - Low Back Pain Clinical Trials

The Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT)

Start date: May 2024
Phase: N/A
Study type: Interventional

The aim of this single-center, observational randomised controlled trial is to evaluate the effectiveness of using Akina Cloud, a remote app-assisted physiotherapy, in managing non-specific low back pain among patients.

NCT ID: NCT06419699 Not yet recruiting - Muscle Weakness Clinical Trials

CPAx: Responsiveness and Minimal Clinically Important Difference

Start date: May 2024
Phase:
Study type: Observational

Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients.

NCT ID: NCT06409117 Not yet recruiting - Clinical trials for Coronary Artery Disease

3rd Generation Resorbable Magnesium Scaffolds vs Biodegradable Polymer Stents in NSTE/ACS

Start date: October 1, 2024
Phase: Phase 4
Study type: Interventional

This is a multicentre, prospective, randomized controlled trial that will investigate the role and performance of the 3rd generation resorbable magnesium scaffolds "DREAMS 3G" labeled under the name "Freesolve" vs contemporary biodegradable polymer scaffolds in non ST-segment elevation acute coronary syndromes. Patients fulfilling the eligibility criteria will be enrolled and undergo PCI with either Freesolve or Orsiro platforms for the culprit lesion only. They will be followed-up for 12 months (1, 6 and 12 months). The primary endopoint will be Target Lesion Failure as defined by ARC definitions.