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NCT ID: NCT06368388 Recruiting - Sepsis Clinical Trials

Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force

PHAGEFORCE
Start date: June 1, 2021
Phase:
Study type: Observational [Patient Registry]

PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration.

NCT ID: NCT06367894 Recruiting - Kidney Stone Clinical Trials

Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care

Start date: December 12, 2023
Phase:
Study type: Observational

Nearly 10% of the Belgian population suffer from kidney stone disease. Recent reviews reported that kidney stones represent an underestimated risk factor for further kidney function deterioration. Preventive measures are recommended in lithiases patients to prevent the formation of new stones. The individual effects of different medicated prosthetic interventions have been documented in clinical trials. However, there is little data on the effectiveness of combining these different preventive measures in routine clinical practice (real-world context). Patients with kidney stone disease require a complete metabolic assessment. The three main factors contributing to the stone's formation are the patient's metabolism, diet and lifestyle. Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hyperuricuria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes at minimum the 24h urine test, a blood test and spot urine test. Dietary habits and lifestyle are assessed by means of a questionnaire. The CHU Brugmann Hospital has a specialized multidisciplinary clinic for renal lithiases and mineral metabolism. Preventive personalized and interdisciplinary care in CHU Brugmann consists of a full metabolic work-up allowing the identification of lithogenic risk factors by nephrologists, dietary assessment by specialized dieticians and specific treatment protocol associated with regular follow-up. The aim of this study is to evaluate, in the context of a retrospective single-center cohort study, the effect of preventive personalized and interdisciplinary care on the evolution of all urinary lithogenic risk factors and the recurrence of kidney stones (rate of renal colics, emergency room admissions, and urological interventions).

NCT ID: NCT06365853 Not yet recruiting - Clinical trials for Recurrent Ovarian Cancer

A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer [PSOC] or platinum-resistant ovarian cancer [PROC]) with high folate receptor alpha (FRα) expression.

NCT ID: NCT06365788 Recruiting - Clinical trials for Triple Negative Breast Neoplasms

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

ABBICAR
Start date: April 8, 2024
Phase: Phase 2
Study type: Interventional

This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.

NCT ID: NCT06363279 Recruiting - Stroke Clinical Trials

Validation of the French ATI Scale and Predisposition to Use Technological Tools in Rehabilitation.

Start date: April 4, 2024
Phase: N/A
Study type: Interventional

Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. It consists of 9 items and was developed to assess a person's tendency to actively engage in technological interaction, or the ease with which a person uses technological tools. Currently, the questionnaire has been translated into French by our research team according to good practice recommendations (Guillemin, Bombardier and Beaton, 1993; Tsang et al., 2017), but this French version has not yet been validated. To validate the translation of a questionnaire, it is necessary to have it completed by a large number of subjects from the population of interest. In neurorehabilitation, measuring this affinity will make it possible to better identify patients who are more likely to adhere to tele-rehabilitation and thus direct them towards this type of treatment as a complement to conventional rehabilitation. The second objective is to determine the extent to which the general population is prepared to use technological tools as part of their rehabilitation. The aim is to gain a better understanding of the profile of people who could potentially benefit from tele-rehabilitation. Accessibility to the technologies, their expectations and barriers will also be explored as part of this study.

NCT ID: NCT06362525 Recruiting - Quality of Life Clinical Trials

Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room

Start date: October 9, 2023
Phase:
Study type: Observational

This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care. Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display. Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated.

NCT ID: NCT06360913 Recruiting - Rare Diseases Clinical Trials

Blood Spot and Urine Metabolomic Screening Applied to Rare Diseases

BUSARD
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The primary goal of this study is to establish a biobank of dried blood spots and urines from a large control cohort and collect several cohorts as large as possible of patients affected or suspected of being affected by rare diseases (mainly hereditary metabolic diseases) or by autism spectrum disorders. A metabolomic database using a high-resolution mass spectrometer (i.e. the "Device") will be generated and specific biomarkers for the diseases will be confirmed or uncovered. The ultimate goal is to facilitate and improve the diagnosis and screening of the patients affected by these disorders, but also to improve the knowledge about the biochemical mechanisms involved over the course of the selected pathologies. High-resolution mass spectrometry allows the measurement of thousands of metabolites in a single analysis. The current biochemical tests used for the diagnosis of hereditary metabolic diseases are only using a combination of maximum a few dozens of biomarkers in one analysis. Objectives Unravel new biomarkers for diagnosis (+/- explore the altered pathways…) Uncover and/or validate newborn screening biomarkers through retrospective analysis of preserved newborn DBS from confirmed patients (useful for first or second tier biochemical NBS testing!) Validation of LC-MS qTOF for metabolomics screening as first line diagnostic test (thousands of metabolites) using diagnostic algorithms (modified z-scores) & continuous optimization by adding new cases and new controls in the database Generation of a biobank of urines and DBS from rare diseases (IEMs) & from a large reference population useful for other research applications

NCT ID: NCT06357754 Recruiting - Multiple Myeloma Clinical Trials

Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy

Start date: October 6, 2023
Phase:
Study type: Observational

The purpose of this transgene assay testing service is to evaluate the tumor samples for transgene levels in patients who received a Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying secondary malignancy.

NCT ID: NCT06355869 Completed - Clinical trials for Spastic Cerebral Palsy

Repeatability of Gait Deviations in Children With Cerebral Palsy

Start date: August 17, 2021
Phase:
Study type: Observational

Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill.

NCT ID: NCT06355167 Completed - Clinical trials for Cardiovascular Diseases

Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress

Bacoxy_I
Start date: March 15, 2022
Phase: N/A
Study type: Interventional

Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress.