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NCT ID: NCT05495854 Recruiting - Clinical trials for Helicobacter Pylori Infection

New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool

Start date: February 3, 2023
Phase: N/A
Study type: Interventional

In France, every year 1 million people are explored for Helicobacter pylori infection and 200,000 receive eradication treatment. Faced with the high prevalence of Hp resistance to antibiotics, the Haute Autorité de Santé (HAS) has recommended since 2017 a treatment strategy guided by the results of bacteriological tests (culture and antibiogram and / or PCR) carried out from gastric biopsies. Guided therapy is more effective, cheaper, and better tolerated than empiric therapy (it includes fewer antibiotics). But the guided treatment is not used despite the recommendations because of the invasive nature of the endoscopy, the difficulty of culture and the non-reimbursement of the PCR. A new non-invasive test by real-time PCR performed on the stools of patients makes it possible to detect the Hp infection and its sensitivity to clarithromycin and therefore to guide the treatment with excellent performance as we have been able to demonstrate during a study including 1200 patients (Pichon et al J Clin Microbiol 2020). These characteristics allow this test to be used in primary care but has to be evaluated.

NCT ID: NCT05495607 Completed - Sepsis Clinical Trials

Continous Renal Replacement Therapy With the CARPEDIEM® in a French National Cohort of 25 Neonates and Small Infants

Start date: December 1, 2018
Phase:
Study type: Observational

Historically, CKRT and hemodialysis were performed in small infants and newborns with devices developed for adults with high rates of complications and mortality. We aim to retrospectively report the first multicenter French experience of CARPEDIEM® use and evaluate the efficacy, feasibility, outcomes, and technical considerations of this new device in a population of neonates and small infant. Compared to adult's device continuous renal replacement therapy with an adapted machine allowed successful blood purification without severe complications even in low birth weight neonates.

NCT ID: NCT05495529 Completed - Neoplasm Metastasis Clinical Trials

Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors

Start date: January 1, 2013
Phase:
Study type: Observational

This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk. Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated. The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process. Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.

NCT ID: NCT05495295 Recruiting - Clinical trials for Advanced Solid Tumor

First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours

PhAST
Start date: July 18, 2022
Phase: Phase 1
Study type: Interventional

The PhAST Trial is an adaptive first-in-human clinical trial of the acetylglucosaminyltransferase V inhibitor PhOx430 in patients with advanced solid tumours conceived and designed with the contribution of the Gianni Bonadonna Foundation, a non-profit academic research institution aimed at promoting therapeutic innovation in oncology.. The trial includes two parts, a dose escalation phase which will enroll patients with non-selected tumour types, followed by a cohort expansion phase in selected tumour types.

NCT ID: NCT05494970 Completed - ORL Cancer Clinical Trials

Accompaniment of Patients by Dental Assistants in the Evaluation of Oral Hygiene During and After Radiotherapy Treatment.

RadioT HBD
Start date: October 13, 2022
Phase:
Study type: Observational

Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy. The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment. Each patient will be followed during 3 months post-radiotherapy (follow-up for up to 12 months post-inclusion).

NCT ID: NCT05494606 Recruiting - Ulcerative Colitis Clinical Trials

An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

PROFUNDUS
Start date: August 15, 2022
Phase:
Study type: Observational

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

NCT ID: NCT05494346 Recruiting - Allergic Rhinitis Clinical Trials

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction

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

The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

NCT ID: NCT05493605 Recruiting - Wilson's Disease Clinical Trials

Cardiac Involvement in Wilson's Disease

WIL-HEART
Start date: March 2, 2023
Phase: N/A
Study type: Interventional

Heart damage by copper accumulation has been reported in Wilson's Disease. However, the disease epidemiology is still poorly understood. A number of studies on pediatric populations have not shown any significant cardiac involvement apart from early dysautonomia. This could suggest that the clinical manifestations related to the copper accumulation in the heart appears with the duration of the disease. Case-control studies on adult populations have highlighted various electrocardiographic (ECG) abnormalities more frequent in patients with Wilson's Disease than in healthy volunteers, but all these studies involved small number of patients (maximum 60). The hypothesis is that there is cardiac involvement in Wilson's Disease, requiring screening, follow-up and appropriate support.

NCT ID: NCT05493293 Terminated - Focal Onset Seizure Clinical Trials

Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

Start date: November 9, 2022
Phase: Phase 2
Study type: Interventional

This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.

NCT ID: NCT05493176 Completed - Weightlessness Clinical Trials

A 5-day Dry Immersion Study on 20 Healthy Male Volunteers

VIVALDI2
Start date: August 23, 2022
Phase: N/A
Study type: Interventional

Dry immersion (DI) is a ground-based model of prolonged conditions of simulated microgravity. Dry immersion involves immersing the subject in water covered with an elastic waterproof fabric. As a result, the immersed subject, who is freely suspended in the water mass, remains dry. Within a relatively short duration, the model can faithfully reproduce most physiological effects of actual microgravity, including centralization of body fluids, support unloading, and hypokinesia. The main objective of the present study is to investigate the physiological effects of 5 days of dry immersion in 20 healthy male subjects, and to obtain DI-in-Men Reference Dataset. A set of measurements will assess the changes in the cardiovascular, neuro-ophthalmological, hematological, metabolic, sensorimotor, immune, muscle and bone systems.