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NCT ID: NCT05933577 Recruiting - Melanoma Clinical Trials

A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Start date: July 19, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.

NCT ID: NCT05933239 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients

MAGMA
Start date: March 30, 2023
Phase: Phase 2
Study type: Interventional

Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with non-small cell lung cancer (NSCLC) planned for surgical resection.

NCT ID: NCT05933057 Recruiting - Clinical trials for Duchenne Muscular Dystrophy

Efficacy, Safety and Tolerability of Givinostat in Non-ambulant Patients With Duchenne Muscular Dystrophy

ULYSSES
Start date: February 19, 2024
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, and tolerability of givinostat in non-ambulant male paediatric (aged 9 to <18 years) patients with DMD. 138 patients will be randomised 2:1 to givinostat or placebo and will be treated for 18 months. - Planned screening duration: approximately 4 weeks (±14 days) - Planned treatment duration: 18 months (approximately 72 weeks) - Planned follow-up duration: 4 weeks (±7 days) (for patients not participating in the long-term safety study) - Total duration of study participation: up to 83 weeks (ie, 20-21 months)

NCT ID: NCT05930236 Recruiting - Clinical trials for Chronic Low-back Pain

Ultrasound-guided LMBB by Caudal-cranial Approach: Radiographic Comparison of a New Ultrasound-guided Method

BLEPAC
Start date: April 21, 2023
Phase: N/A
Study type: Interventional

The current standard technique is radiography requiring three uni- or bilateral punctures (transverse-axial plane). The ultrasound technique is also described mainly in this plan but a new "caudal-cranial" ultrasound-guided technique was described by Chang et al in 2018 in which the major axis is used to conduct the needle to the desired area. The investigators would like to confirm that this new technique in a single puncture is also possible under ultrasound.

NCT ID: NCT05929443 Recruiting - Clinical trials for Benzodiazepines Deprescribing

Benzodiazepines Deprescribing in Nursing Homes: Intervention Feasibility

END-IT NH
Start date: June 22, 2023
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to evaluate the feasibility of a complex intervention towards benzodiazepines and Z-drugs deprescribing in older adults living in the Belgian nursing home setting. The main questions it aims to answer are: - Is the intervention we developped feasible - To what extent will the intervention be implemented in nursing homes - To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants Participants will benefit from a complex intervention implemented at the level of the nursing home, encompassing process and goals setting, healthcare providers education, environmental adaptations, audit and feedback on benzodiazepines use, use of educational leaflet with residents and relatives, and multidisciplinary work. Researchers will compare this intervention to usual care, to see if the intervention is feasible, and to gather first data on intervention effectiveness in benzodiazepines deprescriping.

NCT ID: NCT05929417 Recruiting - Clinical trials for Benzodiazepine Deprescribing

Benzodiazepines Deprescribing in the Community Setting: Intervention Feasibility

END-IT CS
Start date: May 23, 2023
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to evaluate the feasibility of an intervention, led by the pharmacist, aiming at benzodiazepines and z-drugs deprescribing in older adults living in the Belgian community setting. The main questions it aims to answer are: - To what extent will Belgian community pharmacists adhere to the intervention? - To what extent will patients and general practitioners take up the intervention to deprescribe benzodiazepines and z-drugs? - To what extent is the design of the recruitment and data collection process feasible and acceptable for all participants? Participants will receive an educational brochure from their pharmacist. Their pharmacist will also propose to send a new standardized form to their general practitioner to enhance collaboration about a potential benzodiazepine deprescribing. Researchers will compare this intervention to usual care to see if the intervention is feasible and to gather first data on intervention effectiveness in benzodiazepine deprescribing.

NCT ID: NCT05928442 Recruiting - Endometriosis Clinical Trials

Interest of Salivary Signature of Endometriosis in the Heathcare Pathway of Adolescent

ADOmiARN
Start date: June 13, 2023
Phase:
Study type: Observational

ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium. The main objective is to confirm the interest of the in vitro diagnostic medical device (EndoTest®) in adolescents with suspected endometriosis. The study population is made up of females aged 10 to 19 years with formally diagnosed endometriosis or suspected endometriosis. The patients concerned by the study are managed without any change in the care pathway, no any change in the therapeutic indications, no any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the national guidelines. In this study, the management and follow-up of patients : - Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits, - Are not modified in comparison with the usual follow-up, except for the performance of : - Collection of saliva - Completion of a self-questionnaire on symptom and quality-of-life.

NCT ID: NCT05928390 Recruiting - Clinical trials for Post-Bariatric Hypoglycemia

Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

PASIPHY
Start date: January 4, 2024
Phase: Phase 2
Study type: Interventional

The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods - 19 weeks for the Core Phase. It is composed of: - a Screening period: a maximum of 3 weeks - a Run-in period (no treatment): 4 weeks - a Blinded Treatment Phase: 12 weeks - 36 weeks Extension Phase = an open-label Treatment period - 4 weeks for the safety follow-up period (without any treatment).

NCT ID: NCT05926063 Recruiting - Clinical trials for Neutropenia, Febrile

Stopping Antibiotics After 3 Days for the Treatment of High-risk FEbrile Neutropenia

SAFE
Start date: February 26, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare a short course of antibiotics in patients in whom no bacterial infection is found with the current "golden standard": long-term antibiotic treatment in adult hematology patients who develop neutropenic fever. The main question it aims to answer is: whether the short-term treatment is equally safe for patients, hence the name 'SAFE study'. Participants will be randomly assigned (randomized) to one of two treatment options once they develop neutropenic fever: short-term or long-term antibiotic treatment. An additional blood sample, urine sample and stool sample will be collected. Researchers will compare the short-term and the long-term antibiotic treatment groups to see if the short treatment is equally safe as the long-term treatment group.

NCT ID: NCT05926037 Recruiting - Clinical trials for ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION

Evaluation of 3D Simulation and Planning of Left Atrial Appendage Occlusion Based on 3D Echocardiography

USIM-LAAO
Start date: September 26, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to compare a semi-automatic 3D echocardiography-based left atrial appendix occlusion procedure planning with FEops, with other imaging modalities for evaluating the left atrial appendage dimensions and device prediction (sizing, deformation) pre-left atrial appendix occlusion , including the current "gold standard", CT- based FEops HEARTguideTM left atrial appendix occlusion procedure planning. A number of pre-specified endpoints are defined for analyzing this new approach.