Brest Cedex 2, France
A Real-world Study to Evaluate the Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in France (RePhlect)
Phase
N/ASpan
170 weeksSponsor
Bristol-Myers SquibbArras
Recruiting
Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
Phase
N/ASpan
162 weeksSponsor
UNICANCERArras
Recruiting
Ventilator Settings for Bronchoscopy During Mechanical Ventilation: a Randomized Controlled Study
Introduction : Fiberoptic bronchoscopy (FOB) during mechanical ventilation (MV) is a challenging procedure as it considerably reduces the endotracheal tube internal diameter, increasing respiratory resistances, which may compromise the delivering of the ventilatory assistance. According to respiratory physiology principles applied to MV, the reduction of inspiratory flow and tidal volume are likely to reduce airway pressure during the inspiratory phase when respiratory resistances increase. Based on this assumption, we propose new ventilator settings aimed at reducing airway pressure during FOB. This study represents the first investigation to test special ventilator settings in order to facilitate FOB during MV. Methods and analysis : This is a single-center randomized controlled trial, in which intubated patients undergoing a FOB will be assigned (1/1) either to receive the new ventilatory strategy or to stay on the ventilator settings previously selected by the attending physician. The intervention group will be applied the specific ventilator settings (inspiratory flow <25 L/min, tidal volume = 5 mL/Kg, inspiratory time = 1 sec, respiratory frequency <20c/min, positive end expiratory pressure(PEEP) = 5 cmH2O). The primary endpoint will be the reduction of the occurrence of a serious adverse event - inability to deliver the ventilatory support, significant arterial desaturation, or hemodynamics instability - during FOB prompting the interruption of the procedure. The sample size was estimated at a minimum of 46 patients to demonstrate a 50% reduction in the occurrence of such a serious adverse event with a power of 90% and an alpha risk of 0.05 (paired Student t-test). An adjudication committee evaluates images (scope and monitor) to validate primary endpoint. This is done blinding randomization group. Results of this trial should lead to propose a new ventilatory strategy for critically ill patients needing a FOB procedure under MV.
Phase
N/ASpan
108 weeksSponsor
Centre Hospitalier ArrasArras
Recruiting
Rapid Sequence Intubation and Hemodynamic Disorders in the Operating Room: a Prospective Multicenter Observational Study
Phase
N/ASpan
79 weeksSponsor
Nantes University HospitalArras
Recruiting
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
Phase
3Span
106 weeksSponsor
Poitiers University HospitalArras
Recruiting
DESTINY Breast Respond HER2-low Europe
This non-interventional study will investigate the effectiveness withT-DXd, the demographic and clinical characteristics of the patients, treatment patterns, tolerability, management of adverse drug reactions (ADRs), and patient experience of T-DXd in patients with HER2-low unresectable and/or metastatic breast cancer. Patients will be treated according to the proposed indication statement in the Summary of Product Characteristics (SmPC). No drug product will be administered as part of this study. Data on conventional chemotherapy (i.e., including but not limited to capecitabine, eribulin, gemcitabine, paclitaxel and nab-paclitaxel) will also be collected in a disease registry part of the study.
Phase
N/ASpan
254 weeksSponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyArras
Recruiting
Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
Phase
N/ASpan
181 weeksSponsor
University Hospital, LilleArras
Recruiting
Healthy Volunteers
Anger and Psychotrauma: Data From Military and Civilians
Phase
N/ASpan
210 weeksSponsor
Direction Centrale du Service de Santé des ArméesArras
Recruiting
Impact of Metformin on Leptin Transport in Cerebrospinal Fluid of Obese Patients
We hypothesize that the alteration of leptin transport into the CSF of obese patients could be modulated by drugs such as metformin which is widely used worldwide to treat diabetes. This study is monocentric, prospective, one-arm type and interventional. The main objective isto evaluate the impact of metformin on the transport of leptin into the CSF of obese patients. We propose to show a variation of CSF leptin / serum leptin before and after metformin treatment and study its association with changes in hypothalamic metabolic activity, cognitive and appetite-related behaviors and ratio of other metabolic signals. This would support the hypothesis of modulation of resistance to peripheral leptin by metformin and thus uncover a new indication for metformin treatment towards the management of obesity. For this purpose, volunteers will be subjected to blood sampling via venipuncture, CSF collection via lumbar puncture, MRI assessments and questionnaires (cognitive tests, food survey and feeding behavior) before and after a 3-month metformin treatment.
Phase
2Span
222 weeksSponsor
Lille Catholic UniversityArras
Recruiting
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc (GRADE)
The objective of the study is to evaluate the analgesic efficacy of GABAPENTIN versus Placebo in 72h for hospitalised patients suffering from acute lumbosacral radiculalgia due to disc herniation. After signing the consent form, patient's clinical data will be collected and the patient will be allocated to one treatment arm by the randomisation process (ratio 1:1 and stratified on the strong opioid intake). Two treatment arms are possible : - Experimental group: GABAPENTINE per os - DAY1:300 mg - DAY 2: 600 mg - DAY3 : 900 mg - Control group: placebo (same dosage per day as GABAPENTINE).
Phase
4Span
161 weeksSponsor
Lille Catholic UniversityArras
Recruiting