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NCT ID: NCT05817318 Recruiting - Clinical trials for Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation

Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation

REDE-AF
Start date: June 27, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether renal denervation can reduce arrhythmia burden in patients with recurrent, paroxysmal atrial fibrillation despite durable pulmonary vein isolation.

NCT ID: NCT05816382 Recruiting - Narcolepsy Type 1 Clinical Trials

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Start date: April 5, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916).

NCT ID: NCT05816174 Recruiting - Clinical trials for Chronic Post Operative Pain

Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

Start date: November 1, 2023
Phase:
Study type: Observational

Chronic postsurgical pain is defined as pain that develops or intensifies following a surgical procedure. After major surgery, around 20% of children and adolescents develop chronic postsurgical pain, and, as part of it, negative consequences on their quality of life. Emotion-related factors such as the variability of emotions, how emotions are regulated, and how well someone is able to differentiate between different emotions have in part been studied in other types of chronic pain. To date, no study examined emotion-related factors in the development and maintenance of chronic postsurgical pain. This observational study includes five assessment time points, one before and four after major surgery, with the goal to identify emotion-related factors that increase or decrease the risk for the development of chronic postsurgical pain.

NCT ID: NCT05811624 Recruiting - Clinical trials for Chronic Low-back Pain

Lifestyle Intervention in Overweight/Obese Chronic Low Back Pain (CLBP) Patients: an International Multi-center RCT

BO2WL
Start date: April 13, 2023
Phase: N/A
Study type: Interventional

Chronic low back pain (CLBP) is the most expensive cause of workrelated disability: it causes the highest number of years lived with disability. The most severe and debilitated CLBP patients often have comorbidities such as overweight and obesity. Despite the growing body of scientific literature pointing towards the close interaction between overweight/obesity and CLBP, few treatment programs for people with CLBP nowadays take overweight into account. Therefore this study will examine the added value of a behavioral weight reduction program (changes in diet, behavior and physical exercise) to current best evidence rehabilitation (pain neuroscience education plus cognition-targeted exercise therapy) for overweight or obese people with CLBP. An international, multicenter randomized controlled trial comparing a behavioral weight reduction program combined with pain neuroscience education and cognition-targeted exercise therapy versus pain neuroscience education and cognition-targeted exercise therapy alone, will be conducted. The primary outcome is pain and the primary endpoint was chosen at 12 months follow-up; secondary outcomes include health care use and daily functioning (see detailed description of outcomes for an overview of all secondary outcomes). If the promising results of the proof of concept study are corroborated, the new intervention will have a high socio-economic impact, including an annual health care cost reduction of €66 million in Switzerland, and €60 million in Flanders, and is expected to increase life expectancy in the long term.

NCT ID: NCT05811351 Recruiting - Geographic Atrophy Clinical Trials

A Study to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Start date: March 6, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate change in geographic atrophy (GA) lesion growth of eyes treated with JNJ-81201887 compared to sham control.

NCT ID: NCT05809271 Recruiting - Healthy Clinical Trials

Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose

Start date: November 17, 2023
Phase: Phase 1
Study type: Interventional

3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. The current study investigates differences in duration of acute effects and side effects after administration of a single dose of MDMA compared to a repeated administration.

NCT ID: NCT05807854 Recruiting - Rotator Cuff Tears Clinical Trials

RSA vs RCR for Massive RCTs

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Different treatment options are available for massive or irreparable rotator cuff tears. An arthroscopic or an open repair approach is possible in the majority of cases and functional outcomes are improved, particularly when a complete arthroscopic repair can be achieved. However, the healing rate of massive rotator cuff tears after repair may remain low and failure of healing is associated with progression of arthritis. An alternative to arthroscopic or open repair is reverse shoulder arthroplasty which decreases pain and improves function, active shoulder elevation and quality of life. The primary goal of this prospective multicentric randomized study is to determine if there is a difference of functional outcomes between rotator cuff repair (RCR) repair and reverse shoulder arthroplasty (RSA).

NCT ID: NCT05804903 Recruiting - Clinical trials for Transcatheter Aortic Valve Implantation

Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

EMPIRE-II
Start date: November 24, 2023
Phase: N/A
Study type: Interventional

The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months. And the primary performance endpoint is device success at 7 days. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 177 patients need to be enrolled in the study.

NCT ID: NCT05804188 Recruiting - Clinical trials for Intubation Complication

CRICKET: Critical Events in Anaesthetised Kids Undergoing Tracheal Intubation

CRICKET
Start date: January 8, 2024
Phase:
Study type: Observational [Patient Registry]

The investigators' overall objective is to assess the incidence of critical events related to tracheal intubation at all international study sites. Furthermore, the study will investigate the used intubation techniques and identify possible improvement measures to increase patient safety.

NCT ID: NCT05803616 Recruiting - Clinical trials for Lymphoproliferative Disorders

Liquid Biopsy to Enable Diagnostics and Monitoring for Immune-mediated Lymphoproliferative Disorders

LIMPID
Start date: May 23, 2022
Phase:
Study type: Observational

Immune-mediated lymphoproliferative disorders (ILD), as per World Health Organization (WHO HAEM 5) classification, are rare conditions associated with a poor outcome. Current management of ILD is focusing on prevention (e.g.) early detection of ILD with preemptive Epstein Barr virus (EBV) Deoxyribonucleic acid (DNA) levels monitoring, however, this approach is useless for the early detection of EBV-negative ILD. Therapeutic management consists of a reduction in immunosuppressive therapy (RIS), allowing mostly partial and transient responses. Rituximab, an anti-CD20 (cluster differentiation 20) antibody, provides roughly 20-25% of complete and durable responses, thus the majority of ILD patients will require immunochemotherapy, burden with significant toxicity in this challenging population. Implementation of liquid biopsy, also called circulating tumor DNA (ctDNA) in plasma or serum is an area of investigation that is becoming increasingly relevant for clinical practice, allowing for non-invasive monitoring of disease status. Early detection and monitoring of ILD using ctDNA may allow for preemptive therapy, improved risk-stratification and ultimately, lead to outcome improvement. This multicenter Swiss project will allow a better understanding of ILD mutational landscape and pathogenesis, which could lead to the development of new screening and monitoring approaches for patients suffering from ILD.