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NCT ID: NCT05814523 Withdrawn - Clinical trials for Refractory Status Epilepticus

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

Start date: March 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.

NCT ID: NCT05814276 Completed - Dementia Clinical Trials

San Rocco Study: Implementation of the Non-pharmacological Therapies for People With Dementia Living in Nursing Home

Start date: February 11, 2022
Phase: N/A
Study type: Interventional

The goals of this clinical trial are 1) to estimate the number of professional caregivers and the time spent to carry out the non-pharmacological therapies for people with dementia and 2) to evaluate differences between professional caregivers trained and non-trained to non-pharmacological therapies for people with dementia in term of caregivers' burnout and well-being of people with dementia living in nursing home. The main questions it aims to answer are: - How long does it take professional caregivers to implement and carry out non-pharmacological therapies? - How many caregivers are needed to start and carry out non-pharmacological therapies? - Do the non-pharmacological therapies improve the quality of life of people with dementia? - Do the non-pharmacological therapies reduce behavioral and psychological symptoms of dementia? - Do the non-pharmacological therapies improve professional caregiver burnout, sense of competence and ethical climate in nursing home? - Do the non-pharmacological therapies reduce family caregivers' stress? Participants will attend ten sessions: - five theoretical meetings on dementia and non-pharmacological therapies; - five supervision meetings on the methodology for implementing non-pharmacological therapies based on discussions of cases. The investigators will compare the experimental group with an usual care control group to see if there are improvements in term of the quality of life of the resident perceived by the team, professional caregivers burnout, sense of competence of the carers and the ethical climate at the workplace.

NCT ID: NCT05813210 Not yet recruiting - Clinical trials for Myocardial Ischemia Demand

Myocardial Ischemia Detection With a Combined Cardiovascular Magnetic Resonance and Biomarker Protocol

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

Background: Early detection and treatment of coronary artery disease (CAD) can help curb the high incidence of cardiovascular disease, which is the leading cause of death worldwide. Today, we have sophisticated imaging techniques available to diagnose CAD, including cardiovascular magnetic resonance (CMR). CMR is able to detect relevant myocardial ischemia and guide treatment options. Therefore, it is recommended by the current guidelines for patients at intermediate risk. In clinical practice, we often encounter two main issues: first, because of their availability and increasing uncertainty in the population, imaging techniques are increasingly used, even in patients with a low pretest probability for the presence of CAD. Second, the diagnostic accuracy of the techniques is not perfect, and false-negative stress CMR perfusion studies are an important limitation of the method, especially in patients with advanced CAD and balanced ischemia. In addition, the standard method with pharmacologic testing carries an inherent risk. Aim: The aim of our project is to review the clinical pretest probability to reduce unnecessary imaging studies and to evaluate the improvement of diagnostic accuracy of CMR stress testing by adding exercise test and reviewing biomarkers, which could reduce the number of false-negative results, especially in patients with balanced ischemia, who usually suffer from severe CAD. Methodology: This is a prospective, randomized, two-arm, controlled, monocentric, national study performed in collaboration by two centers (Solothurner Spitäler AG and CRIB). Included are consecutive patients with suspected inducible myocardial ischemia who are examined by CMR at the Kantonsspital Olten and during the course also at the Bürgerspital Solothurn. Since all patients from the Kanton Solothurn are referred to us for CMR diagnosis, this represents an ideal referral pattern of unselected patients with a wide range of pretest probability for myocardial ischemia (interquartile range of pretest probability 20-60%). Patients able to exercise will randomized to either standard CMR stress protocol with regadenoson or to the combined CMR stress protocol, which includes additional exercise testing and measurement of hs-cTn, a biomarker for detecting myocardial damage. Patients with positive CMR results will be received to coronary angiogram. Potential Significance: This project has the potential to reduce the residual risk and thereby reduce cardiovascular mortality in patients with false-negative test result, especially those with balanced ischemia or inadequate response to vasodilatation drugs. In addition, the investigator will be able to make a statement about the additional use of biomarkers for the diagnosis of CAD in patients with stable condition. Thereby, the integrated use of biomarkers may improve the diagnostic accuracy and this might prevent unnecessary further strategies, which will reduce high-cost in health care systems. Furthermore, the investigator hopse for better patient selection in order to avoid unnecessary examinations in the future.

NCT ID: NCT05812313 Enrolling by invitation - Mental Health Issue Clinical Trials

Educators and Young People's Mental Health

Start date: January 26, 2023
Phase:
Study type: Observational

The aim of the present study is to assess the current state of mental health of educators and young persons at the education centre for health and care professions in St. Gallen (BZGS) by conducting screening instruments. Furthermore, the investigators aim to identify risk and protective factors for the mental health of vocational trainees in health and care professions. These results are both essential for further research and educational practice. Moreover, results may maximise the chances of creating in future meaningful intervention for young persons in this specific setting.

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: NCT05809531 Active, not recruiting - C3 Glomerulopathy Clinical Trials

An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

VALE
Start date: May 29, 2023
Phase: Phase 3
Study type: Interventional

This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

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.