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NCT ID: NCT05374382 Not yet recruiting - ACL Injury Clinical Trials

A Prehab Strengthening Program Prior to ACL Surgery on Lower Limb Structure and Function

ACL-Strong
Start date: September 2022
Phase: N/A
Study type: Interventional

Atrophy and weakness are ubiquitous after a ACL rupture and associated with a worsened long-term recovery of individual capacities, despite surgery and rehabilitation. Preoperative rehabilitation (prehab) is believed to prepare patients for surgery and post-operative rehabilitation. However, prehab programs are highly variable, and do not always aim to develop/maintain neuromuscular parameters. The purpose of this study is to assess the effects of a lower limb strengthening training program during prehab prior to ACL Surgery on lower limb structure and function.

NCT ID: NCT05373524 Not yet recruiting - Hemodialysis Clinical Trials

Rheopheresis Mechanism in Hemodialysis Patients With PAD

VALLOIRE
Start date: June 2022
Phase: N/A
Study type: Interventional

Peripheral arterial disease (PAD) is common in chronic hemodialysis patients (HDC) with a prevalence of 30% according to the DOPPS study. The combination of PAD and chronic kidney disease (CKD) stage 5 is a risk factor for major amputation (24.5%) with a mortality rate of 55% at 2 years. Ischemia occurring during PAD is the result of impaired microcirculation, with insufficient blood flow to maintain tissue perfusion and viability. It is responsible for painful skin wounds whose healing is poor, with a significant risk of infection. In patients with chronic renal failure, it is linked to both: - local phenomena (atherosclerosis, calcification) - changes in blood viscosity (elevated hematocrit and inflammatory proteins, especially fibrinogen) - a neovascularization defect (uremic toxins, in particular indoxyl sulphate). If revascularization is not possible, amputation remains the only possible treatment to relieve pain and limit the risk of infection. Rheopheresis is an apheresis technique that allows the depletion of high molecular weight serum proteins. This would reduce blood viscosity and red blood cell (RBC) aggregation, thereby improving microvascular perfusion, with the aim of reducing pain, improving healing and limiting the risk of amputation. Several studies have investigated the efficacy of rheopheresis in PAD in HDC, but the level of evidence remains low.

NCT ID: NCT05373264 Not yet recruiting - ADPKD Clinical Trials

HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life

HYDRO-PROTECT
Start date: March 2024
Phase: Phase 3
Study type: Interventional

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function. Tolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.

NCT ID: NCT05373069 Not yet recruiting - Breast Cancer Clinical Trials

BENEFIT OF MECHANICAL ISCHEMIC PRECONDITIONING ON TOLERANCE OF ADIPOSE TISSUE TO ISCHEMIA REPERFUSION OF TYPE DIEP (DEEP INFERIOR EPIGASTRIC PERFORATOR) FREE FLAPS.

PRIMIDIEP
Start date: May 2022
Phase: N/A
Study type: Interventional

Breast cancer is the most common cancer amongst women in terms of frequency, with more than 50 000 newly diagnosed cases per year in France. The average 5-year survival rate for women with breast cancer is around 85%. Surgical treatment by total mastectomy concerns around 30% of cases. For patients who have been treated for breast cancer by total mastectomy, secondary breast reconstructions are often carried out via excess abdominal fat flaps of DIEP type. Postoperative partial fat necrosis is a common complication of breast reconstruction. This necrosis is qualified as pathological when it is palpable or when there are symptoms leading to pain, deformation, or leakage. Necrosis occurs in the first 6 months after surgery. Diagnosis is carried out by the detection of a nodule of fat necrosis measuring at least 5 mm on the ultrasound. Partial flat necrosis results from ischemia reperfusion (IR) to the fat tissues during reconstruction. IR leads to inflammatory lesions, edema, capillary occlusion that can lead to tissue necrosis. The deleterious impact of IR has been shown on the organs (liver, kidney) on muscular, cutaneous and adipose tissues in humans and animals. Ischaemic preconditioning is a procedure used in organ transplant surgery, allowing a better tolerance of the graft for ischemia reperfusion, without further complications. It is used in usual practice for kidney or liver transplants; short cycles of ischemia reperfusion are carried out on the organ pedicle before harvesting using cold ischemia (out of the donor's body) pre-transplant. Ischaemic preconditioning before reconstruction has been studied in animal models but not in human reconstruction surgery, although it seems to be beneficial. For patients undergoing total mastectomy after being diagnosed with breast cancer, we hypothesize that ischaemic preconditioning, usually used for organ transplants, could decrease adipose tissue lesions caused by ischemia reperfusion after breast reconstruction with DIEP (deep inferior epigastric perforator) flaps.

NCT ID: NCT05370690 Not yet recruiting - Uveitis Clinical Trials

Retrospective Comparison of the Efficacy of Methotrexate and Azathioprine as Background Treatment for Uveitis of Undetermined Origin: Single-centre Retrospective Study From 2005 to 2020

UMetAza
Start date: May 1, 2022
Phase:
Study type: Observational

Retrospective study at the Brest universitary hospital to evaluate the efficacy of methotrexate (MTX) and azathioprine (AZA) in background treatment of unidentified non anterior uveitis.

NCT ID: NCT05367726 Not yet recruiting - Clinical trials for Skin Graft Complications

The Contributions of the Multidisciplinary Management of Prosthesis Knee Infections in a Reference Center: A Retrospective Study About 52 Cases.Skin Coverage in a Reference Center: A Retrospective Study About 52 Cases

Start date: May 1, 2022
Phase:
Study type: Observational

Acute and chronic infection of knee joint prosthesis can have several outcomes, the most feared of which is trans-femoral amputation. In order to save the limb while maintaining function, the management of these infections involves several specialists. Orthopedic surgeons are on the front line for carrying out bacteriological samples as well as for changing the material when necessary. The infectiologists coordinate this care by supervising each of the interventions by an antibiotic therapy adapted to the germs and by ensuring the occurrence of adverse events related to the treatment. Plastic surgeons intervene when the skin cover of the knee is deemed to be precarious or when there is an identified loss of substance that could affect the prognosis of the prosthesis. The main objective of our study is to evaluate the success rate of skin coverage and functional recovery for patients cured of their infection. The secondary objective is the identification of risk factors for skin coverage in this population.

NCT ID: NCT05366127 Not yet recruiting - Bullous Pemphigoid Clinical Trials

Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid

IGA score
Start date: July 1, 2022
Phase:
Study type: Observational

The aim of the study is to validate a global and simple score : IGA (Investigator Global Assessment) score for the evaluation of the extent and severity of the disease in patients with bullous pemphigoid

NCT ID: NCT05363124 Not yet recruiting - Clinical trials for Pediatric Triage in a Pediatric Emergency Department

Evaluation of Mobile App to Assist in Pediatric Triage

PEWSAPP
Start date: September 2024
Phase: N/A
Study type: Interventional

Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool. In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs. In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual). Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in a pediatric emergency department using the mobile application Caducy® (i-Virtual)

NCT ID: NCT05362565 Not yet recruiting - Monogenic Obesity Clinical Trials

Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity

OBEGENE
Start date: October 1, 2022
Phase:
Study type: Observational

Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.

NCT ID: NCT05358405 Not yet recruiting - Weaning Clinical Trials

Prediction Of Pulmonary Edema With Müller Maneuver

PoEM
Start date: May 9, 2022
Phase: N/A
Study type: Interventional

The mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient. However, some patients fail this test and cannot be extubated. The main causes are pulmonary edema and diaphragmatic dysfunction. Predicting the risk of failure before carrying out the SBT makes it possible to anticipate a failure of the extubation and to adapt the therapies as well as possible. To assess the risk of pulmonary edema, cardiac preload, which corresponds to the end-diastolic filling volume of the ventricle, can be estimated using simple tests as the passive leg raising test before an SBT. However, this test requires tilting the patient's trunk and raising the lower limbs to 45°, and is not practical, especially in intensive care. The Müller maneuver, which allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube, is currently used in routine care for diaphragmatic assessment. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with a reserve of preload, i.e. in preload-dependent patients. This test would be an easy alternative to the passive leg raising test used in current practice. The objectif is to assess whether the presence of an independant prelaod state, as detected by the absence of increased cardiac output during the Müller maneuver, is associated with the occurence of pulmonary edema during weaning from mechanical ventilation. The study consist in the measurement of cardiac output before and after the passive leg raising test and the Müller maneuver, then measurement of cardiac output before and after an SBT. A transthoracic ultrasound and a blood sample with dosage of proteins and hemoglobin will be carried out initially and then at the end of the SBT as part of routine care. The investigators hypothesize: - The Müller maneuver induces a greater increase in cardiac output in patients in a state of preload dependancy than in patients in a state of preload independancy. - The absence of documented preload dependancy during a Müller maneuver is associated with the occurrence of pulmonary edema during an SBT. The investigators included patients : - > 18 years old, conscious patient, with health insurance, placed under mechanical ventilation for at least 24 hours ; - In whom it was decided to perform a passive leg raising test and an SBT. The investigators excluded pregnancy, patient with chest tube, particpation in another interventional study, tracheostomy, patient under legal protection.