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NCT ID: NCT06192693 Not yet recruiting - Type 2 Diabetes Clinical Trials

Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery

DRIFTER
Start date: January 2024
Phase: Phase 3
Study type: Interventional

Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly. BS improves diabetes (T2D) and even induces diabetes remission (DR) in 60% of patients. Thus, an expert consensus recommended extending BS to T2D with BMI≥30kg/m² with uncontrolled glycaemia, anticipating even more BS. Glycaemic control further deteriorates in the longer term in non DR (NDR) patients and relapse occurs in some DR patients, urging the need to add new therapy to control glycaemia and provide new recommendations in the future. Obesity and T2D are characterized by gut microbiota dysbiosis with low to very low microbial gene richness (MGR). About 75% of patients' candidates for BS are in the low MGR category. Whereas BS modifies microbiota composition and increases MGR 1-year post-BS, we demonstrated that only a few patients reach high MGR. Dysbiosis can be improved by several means; fibre enriched diet, prebiotics, probiotics also improve metabolic alterations and insulin resistance in mice. However, human studies observed rather divergent results: some studies display a beneficial effect in improving insulin-resistance but to a small extent while others do not display any significant effects at all. Therefore, other innovative strategies should be tested in humans. For example, Faecal microbiota transfer (FMT) ameliorates insulin sensitivity and MGR in metabolic syndrome patients, but was never tested in T2D nor post-BS. Whether adding such an innovative therapy to further modify gut microbiota post-BS can help improve glucose control should be tested. FMT showed health benefits in several diseases (clostridium difficile (CD) and Crohn's). Until recently, FMT was performed using invasive tool (endoscopy or colonoscopy) thus with potential secondary effects, or enema yet maybe less effective. Recent technologic developments enabled to generate oral capsulized FMT (filled with fecal material) performing as well as invasive FMT for CD with good tolerance. This strategy has never been tested in obesity or T2D, whereas in metabolic syndrome patients (before T2D occurrence) and less severe dysbiosis, a proof-of-concept study showed that endoscopic FMT may improve insulin sensitivity after 6 weeks. Yet these studies have included a small number of patients, non T2D and did not test oral FMT. We here hypothesize that an intervention improving dysbiosis after 1-year post-BS might help improve/maintain diabetes control in the long-term. We will examine the effects of FMT (from lean healthy donors) vs. placebo transfer in dietary-controlled non-DR patients after 1-year post-BS, on Hba1c reduction evaluated 6 months' post-intervention

NCT ID: NCT06191731 Recruiting - Clinical trials for Magnetic Resonance Imaging

Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations

GADODURABLE
Start date: April 12, 2024
Phase: N/A
Study type: Interventional

This is a single-center cohort study aimed to describe the urinary excretion kinetics of gadolinium contrast agents (Gd-CAs). Patients with a prescription for injected MRI are invited to participate in the study. If they agree, blood and urine samples are collected before Gd-CAs injection, and urine samples are collected between 0- and two-and-a-half-hours post-injection of Gd-CAs.

NCT ID: NCT06191601 Recruiting - Joint Infection Clinical Trials

Interest in Probabilistic Antibiotic Therapy With Broad-spectrum Beta-lactams in Orthopedic Surgery

Prob-ATB
Start date: July 17, 2023
Phase:
Study type: Observational

The management of Joint Infections (JIs) requires a medical-surgical team which includes rheumatologists, infectious disease specialists, orthopedists as well as microbiologists. This collaboration makes it possible to optimize patient care both from a functional point of view and from an infection point of view. The diagnosis of these infections is based on clinic, imaging and bacteriology (microbiological samples). Treatment is based on surgical treatment and appropriate antibiotic therapy, which will be charged only after the sample has been taken. For non-complex native septic arthritis, identification of the bacteria is expected before starting antibiotic therapy adapted to the germ. For patients requiring surgical treatment: patients with complex native joint infections (comorbidities, allergies, etc.) or joint infections on hardware, the identification of the incriminated germ(s) cannot be expected. Probabilistic antibiotic therapy is then started while awaiting the microbiological results. This antibiotic therapy generally lasts 48 hours, while the results of the antibiogram are known. If for (JIs) on native joints recent recommendations were published by the French society of rheumatology in 2020, it is not the same for (JIs) on hardware. As a result, no updated recommendations indicate the probabilistic antibiotic therapy to prescribe immediately post-operatively. Currently, the old recommendations are no longer applied regarding positive grams. Daptomycin is preferred over vancomycin. On the other hand, for gram-negative germs, broad-spectrum beta-lactams are always prescribed. The investigators are questioning the benefit of these prescriptions given the epidemiological context of joint infections and bacterial resistance phenomena. The investigators hypothesize that osteoarticular infections are mainly due to gram-positive bacteria. By affirming this hypothesis, investigators could avoid prescriptions for broad-spectrum beta-lactams. This would lead to a reduction in patient exposure to broad-spectrum antibiotics (fewer adverse effects, ecological and economic gain).

NCT ID: NCT06191341 Completed - Clinical trials for SARS CoV 2 Infection

Consequences in ICU of Vaccination Status of Covid-19 Patients

CIVIC
Start date: January 1, 2023
Phase:
Study type: Observational

It is a retrospective cohort study aiming to describe the characteristics, management and prognosis of vaccinated patients hospitalized in the intensive care unit (ICU), in comparison with non-vaccinated patients.

NCT ID: NCT06191263 Recruiting - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML

RIVER-81
Start date: January 5, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts. Part 1 aims to identify the doses of RVU120 and venetoclax that are considered to be safe and tolerated. Part 2 will assess the safety and efficacy of the doses selected. And Part 3 is a confirmatory cohort where patients will be treated at the same doses assessed in Part 2

NCT ID: NCT06191146 Recruiting - Dialysis Clinical Trials

Factors for Impairment of Renal Graft Function in Intensive Care

RENAGRAF
Start date: January 1, 2024
Phase:
Study type: Observational

hypothesis = hospitalization in the intensive care unit (ICU) has an impact on the outcome of the renal graft, due to the therapeutic and exploratory procedures performed. the aim is to identify risk factors for renal graft degradation in the ICU up to 2 years after hospitalization. Optimization of renal graft management in the ICU and management by nephrologists after the ICU

NCT ID: NCT06190899 Recruiting - Prostate Cancer Clinical Trials

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Start date: January 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.

NCT ID: NCT06190821 Recruiting - Hepatic Lesions Clinical Trials

Hydrodissection of the Hepatoduodenal Ligament

Duodenal
Start date: July 20, 2022
Phase:
Study type: Observational

Percutaneous treatment of liver lesions adjacent to the duodenum exposes the duodenum to the risk of thermal injury, limiting removal and oncologic outcome. In this study the investigators investigate the feasibility of hepato duodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum.

NCT ID: NCT06190756 Recruiting - Healthy Clinical Trials

Impact of Gravity on Cardiac Hemodynamics

ACUITY
Start date: November 22, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to define and compare pre-load dependance of the cardiac function according to the intracardiac hydrostatic gradient of pressure in healthy and diabetic populations. Participants will undergo 4 tilt angle and 4 lower body negative pressure intensities during which cardiovascular data will be assessed and a transthoracic echography will be performed.

NCT ID: NCT06190522 Completed - Clinical trials for Acute Kidney Failure

Diagnosis of Acute Obstructive Renal Failure by Clinical Ultrasound Performed by the Emergency Physician.

IRASMU
Start date: July 6, 2021
Phase:
Study type: Observational

Acute renal failure is frequently diagnosed in the emergency room during a biological assessment. Its discovery requires determining the cause, which may be either functional, or obstructive. The obstructive cause is responsible for 10% of acute renal failure. It is recommended to start the exploration of this pathology with an ultrasound in search of an obstructive cause. However, ultrasound from the radiologist is not always available. The realization of this ultrasound by the emergency physician would reduce the time to obtain the diagnosis and therefore the time of passage to the emergency room. No study has yet been carried out to validate the performance of this ultrasound by the emergency physician in the case of acute renal failure. This study would validate the diagnostic performance of this ultrasound technique in order to identify as quickly as possible patients with acute renal failure whose cause is obstructive.