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NCT ID: NCT06029660 Recruiting - Clinical trials for Aortic Aneurysm, Abdominal

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

Start date: April 5, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06028048 Recruiting - Cancer Survivors Clinical Trials

Enhancing Work Participation of Unemployed and Work-Disabled Cancer Survivors

PLACES
Start date: September 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effectiveness of the PLACES intervention on paid employment re-entry in unemployed and work-disabled cancer survivors, compared to CAU. Secondary Objectives are: - To evaluate the cost-effectiveness of the PLACES intervention aimed at unemployed or work-disabled cancer survivors. - To evaluate the effectiveness of the PLACES intervention on time until paid employment, type of employment, change in working hours, quality of life, quality of working life, work ability, and self-efficacy regarding RTW, in unemployed or work-disabled cancer survivors. - To evaluate the process of conducting the PLACES intervention in terms of recruitment, reach, dose delivered, dose received, fidelity and context. Participants in the intervention group will receive the PLACES intervention with a maximum duration of 1 year, and participants in the control group will receive CAU.

NCT ID: NCT06027008 Recruiting - Critically Ill Clinical Trials

Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults

ACACIA
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients. The main question[s] it aims to answer are: - Is MI-E feasible? - Is MI-E safe? Participants in the intervention group will receive: - MI-E - Airway secretions will be removed by endotracheal suctioning, as part of routine airway care. - Manual hyperinflation will only be used when necessary in an emergency situation. Patients in the control group will receive endotracheal suctioning and manual hyperinflation when clinically indicated. The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study protocol (feasibility). Secondary outcomes are the total number of serious adverse events in relation to MI-E (safety) and preliminary exploratory data on the need for airway care interventions and clinical outcomes including duration of invasive ventilation, length of stay in ICU and mortality (efficacy).

NCT ID: NCT06026189 Recruiting - Bladder Cancer Clinical Trials

Safely Reduce Cystoscopic Evaluations for Hematuria Patients

SeARCH
Start date: May 31, 2023
Phase: N/A
Study type: Interventional

The SeARCH-trial assess the clinical impact of a molecular urine test as a 'urine-first' strategy in the diagnostic workup of patients presenting with microscopic hematuria.

NCT ID: NCT06025578 Recruiting - Clinical trials for Progressive Pulmonary Fibrosis

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

NCT ID: NCT06023589 Recruiting - Asthma Clinical Trials

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

HORIZON
Start date: August 24, 2023
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

NCT ID: NCT06021093 Recruiting - AYA Cancer Patients Clinical Trials

HYPNAYA Feasibility Study

Start date: July 17, 2023
Phase:
Study type: Observational

Adolescents and young adults (AYAs) with a cancer diagnosis experience high levels of stress during and after treatment. Hypnotherapy as supportive treatment throughout regular cancer care may reduce symptoms of distress, and improve sleep and health-related quality of life in AYAs with cancer. The objective of this pilot study is to demonstrate feasibility of hypnotherapy as supportive treatment.

NCT ID: NCT06019429 Recruiting - Healthy Clinical Trials

Promoting Social-emotional Development and Self-esteem in Primary School Students

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

This is an effectiveness study into a program ("HiRO") for improving social-emotional development, self esteem and the perceived classroom peer context in primary school students (aged 4-13 years). To this end, schools are divided into three conditions based on the choice of the schools (non-randomized): 1) School As Usual, 2) HiRo without judo classes, and 3) HiRO with judo classes. In all participating schools, social-emotional skills, self-image, emotional problems, and classroom peer context are measured three times by means of questionnaires (both self-report and parent-report). In The Netherlands primary schools are obliged to offer students training in social-emotional development. Schools can decide to develop their own program or make use of existing programs delivered by third parties, such as HiRO. In this study HiRO is compared to school as usual, that is, any other program offered to promote social -emotional development than HiRO. The main questions to answer are: - What is the effect of HiRO on the development of prosocial behavior? - What is the effect of HiRO on the development of emotional problems (depression, anxiety)? - What is the effect of HiRO on self-esteem? - What is the effect of HiRO on perceived peer context? Researchers will compare HiRO with and without judo to "school as usual" testing the following hypotheses: HiRO will result in increased prosocial skills as compared to school as usual. HiRO will result in decreased emotional problems as compared to school as usual. HiRO will result in increased self-esteem as compared to school as usual. HiRO will result in improved perceived peer context as compared to school as usual.

NCT ID: NCT06018792 Recruiting - Sepsis Clinical Trials

Molecular Culture for the Diagnosis of Pediatric Sepsis

CHAMPIONS
Start date: March 10, 2024
Phase:
Study type: Observational

Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the symptoms are often unclear and can also occur in children who are not sick. To determine whether there is an infection, a little blood is currently taken for a blood test (the blood culture) to investigate whether there is a bacteria in the blood. However, it often takes at least 36 hours before the results of this blood culture are available. That is why antibiotics are usually started immediately to treat the possible infection. However, it often turns out that the blood culture is negative after 36 hours, which means that no bacteria have been found in the blood. Usually the antibiotics are then stopped because it turns out that there was no infection at all. There is currently no good test that can predict whether (newborn) children have an infection or not. That is why too many children are currently wrongly receiving antibiotics. These antibiotics can damage the healthy bacteria in the intestines. There are many billions of 'beneficial bacteria' in the intestine. These play an important role in the digestion of food and protect against external infections. Antibiotics aim to kill bacteria that cause inflammation or infection. Unfortunately, antibiotics also kill some of these beneficial bacteria. In addition, unnecessary use of antibiotics contributes to antibiotic resistance. The aim of this research is to investigate whether Molecular Culture, a PCR based test that can identify bacterial pathogens in bodily fluids within 4 hours, has greater accuracy than traditional culturing techniques for bacteria in blood. If proven, this could lead to faster identification or exclusion of sepsis in children.

NCT ID: NCT06016946 Recruiting - Friedreich Ataxia Clinical Trials

Friedreich Ataxia Global Clinical Consortium UNIFIED Natural History Study

UNIFAI
Start date: June 28, 2023
Phase:
Study type: Observational [Patient Registry]

This project is a global, multicenter, prospective, longitudinal, observational natural history study that can be used to understand the disease progression and support the development of safe and effective drugs and biological products for Friedreich ataxia.