Brive La Gaillarde

This research aims to assess the safety and performance of Teknimed arthroplasty products, including the CEMFIX and GENTAFIX bone cement families and the CEMSTOP cement restrictor, which have been used for more than 20 years in joint replacement surgeries. The study focuses on real-life long-term data to confirm previous findings on these products safety and effectiveness in patients undergoing joint replacement due to osteoarthritis, osteonecrosis, trauma, or revision surgeries. The study is a global, multicenter, observational trial that collects both retrospective and prospective data from patients receiving primary or revision joint replacements involving Teknimed bone cements and cement restrictors. Different groups include patients undergoing knee, hip, or shoulder surgeries with various cement types. Patients receive treatment as part of their standard medical care, without additional interventions mandated by the study. Participants will be monitored according to local medical practices, with data collected on outcomes such as implant survival, infection rates, pain levels, patient satisfaction, function restoration, complications, and adverse events. The primary outcomes cover up to 15 years, focusing on device lifetime and postoperative infections, while secondary outcomes evaluate patient-reported and clinical measures over five years. This long-term follow-up aims to provide comprehensive safety and performance information for these arthroplasty products.

Researchers are studying prostate cancer patients undergoing radical prostatectomy to compare three surgical methods robot-assisted laparoscopy, conventional laparoscopy, and laparotomy. The study aims to evaluate the impact of these techniques on urinary and erectile functions, as well as their cost-effectiveness and long-term outcomes. This large, multicenter prospective observational study responds to previous concerns about the lack of high-quality evidence for robot-assisted surgery in prostate cancer treatment. Participants will undergo one of the three prostatectomy procedures robot-assisted laparoscopy, conventional laparoscopy, or laparotomy. Urinary and erectile functions will be assessed before and after surgery using standardized scores like the EPIC 50 and the International Index of Erectile Function IIEF-5. Outcomes including urinary incontinence, erectile dysfunction, and prostate-specific antigen PSA levels will be followed for up to five years. Cost-effectiveness will be evaluated at 12 months using the EQ5d-5L score. Throughout the study, participants will be evaluated at multiple time points, including 45 days and up to five years after surgery, to monitor urinary and erectile functions and other prostatectomy-related effects. Assessments involve questionnaires and clinical measurements. This comprehensive follow-up is designed to help determine the benefits and risks of each surgical approach, supporting informed decisions for patients and healthcare authorities. The study excludes patients without French health insurance or those unable to consent, focusing on adult males scheduled for prostatectomy.

Researchers are evaluating the use of Esmolol compared to Sufentanil during general anesthesia for outpatient laparoscopic cholecystectomy with orotracheal intubation. The study aims to see if Esmolol can provide an equivalent quality of recovery and pain control after surgery, potentially avoiding some side effects linked to morphine-based drugs like Sufentanil. Esmolol is a cardioselective beta-blocker that acts quickly and may offer benefits in outpatient settings. The study involves 120 adult patients scheduled for outpatient laparoscopic cholecystectomy. Participants are randomly assigned to receive either Esmolol 1 to 1.5 mgkg at induction or Sufentanil 0.1 to 0.3 mcgkg at induction during anesthesia. The trial includes three visits an inclusion visit for eligibility screening and consent, a surgery day visit with randomization and monitoring, and a follow-up telephone visit the day after surgery to assess recovery and painkiller use. During the study, researchers will collect data on vital signs, patient characteristics, and recovery quality using a 15-question questionnaire conducted over the phone after surgery. They will monitor patient comfort and pain control, as well as medication use at home. Participants vital signs and eligibility are carefully checked before surgery, and the study lasts about two days per participant with ongoing medical supervision and the option to withdraw at any time.

This research aims to better understand how pregnancy affects women with multiple sclerosis MS and related neurological conditions, including neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody-related disorders. The study focuses on important questions about the use of disease-modifying drugs during pregnancy, the effects on the mothers health and disability, the childs health, breastfeeding, and pain management during delivery. It is a national, prospective, observational study conducted within the French MS cohort called Observatoire Franais de la Sclrose en Plaque OFSEP. Women with MS or related disorders who are pregnant will be followed throughout their pregnancy and for one year after giving birth. Their children will also be monitored until they reach six years of age. There is no intervention or treatment given as part of this study instead, it collects detailed information on the course of MS during pregnancy and postpartum, including any use or discontinuation of disease-modifying drugs and other pregnancy-related factors. Participants will have regular follow-ups during pregnancy and postpartum to assess their health and any treatment-related side effects. Researchers will collect data on relapses, disability progression, breastfeeding, and use of pain relief during delivery. Children born to these women will be observed for up to six years to evaluate long-term outcomes. The main outcomes measured include the number of treatment-related adverse events during pregnancy and postpartum, helping to improve knowledge for neurologists and families regarding MS and pregnancy.

Out-of-hospital cardiac arrest is a serious health issue with survival rates below 10%. The main cause of death in intensive care units after such an event is post-cardiac arrest syndrome, which leads to shock or brain injury due to lack of oxygen. Brain injury may worsen if blood flow is not properly maintained in the first hours after the heart starts beating again. This research aims to compare two blood pressure targets to see if higher blood pressure after cardiac arrest improves brain function recovery. Participants will be randomly assigned to one of two groups. One group will receive treatment to keep their mean arterial pressure MAP at or above 90 mmHg for 24 hours using norepinephrine. The other group will have a standard target MAP of at least 65 mmHg for 24 hours with the same medication. After the initial 24 hours, both groups will aim for MAP of 65 mmHg until they leave the ICU. During the study, patients will be monitored for brain function and survival for up to 180 days. Researchers will evaluate neurological outcomes, survival rates at various points, quality of life, frailty, and kidney function. The study includes measurement of days without ICU stay, ventilator, or kidney therapy. Safety and long-term outcomes will be assessed to understand the effects of different blood pressure targets after cardiac arrest.

Researchers are evaluating the use of Interferon gamma to prevent secondary infections in patients with sustained immunosuppression acquired in the ICU. This phase 3 randomized trial aims to assess whether Interferon gamma reduces the number of secondary infection episodes at three months, lowers ICU mortality at day 90, shortens ICU and hospital stays, and promotes biological immune restoration by day 10. The study also examines cost-effectiveness and safety of Interferon gamma compared to a placebo. Participants will receive injections of Interferon gamma-1b or a placebo subcutaneously, preferably in the deltoid area or the front thigh. They will be given up to five injections between day 1 and day 9. The placebo consists of a saline solution with the same volume as the active drug. The treatment period lasts for up to nine days. During the trial, participants will be monitored daily until they leave the ICU, with follow-up visits at days 30, 60, and 90. Researchers will assess infection rates, causes of death, length of ICU and hospital stay, antibiotic and antifungal use, immune system recovery, healthcare costs, and any serious adverse reactions. The total participation duration extends to 90 days after treatment begins to evaluate outcomes and safety.

Researchers are evaluating whether giving amiodarone for 72 hours can reduce deaths and severe heart rhythm problems within 30 days in critically ill adults admitted after an out-of-hospital cardiac arrest with an initial shockable heart rhythm and a confirmed or suspected cardiac cause. This phase 3 trial is randomized and compares patients receiving amiodarone to those receiving no intervention. The study is sponsored by Versailles Hospital. Participants in the amiodarone group receive an initial 300 mg loading dose over 30 minutes, followed by a continuous infusion for 72 hours at 10 mgkg per day, not exceeding 900 mg per 24 hours. The control group does not receive amiodarone. Treatment starts shortly after admission to intensive care and screening. The study measures outcomes for up to 90 days, including heart-related events, mortality, ventilation duration, neurological status, vasopressor use, and hospital stay length. During the study, patients are closely monitored in intensive care with regular assessments of their heart condition and overall health. Researchers track serious ventricular arrhythmias and death rates over 30 days as the main outcome. Secondary outcomes include longer-term cardiac events, neurological outcomes, and side effects related to amiodarone within 5 days. The total follow-up lasts up to 90 days, during which participants responses to treatment and safety are carefully observed.

The Dataids cohort is a large, ongoing observational study following over 30,000 HIV-infected patients receiving care at more than 15 HIV centers across France. The study aims to monitor clinical practice, changes in the course of HIV infection and related co-infections or co-morbidities, and assess factors influencing the clinical, immunological, and virological outcomes of HIV. It also evaluates the effectiveness of antiretroviral therapy ART and outcomes related to hepatitis C virus HCV treatment. Patients enrolled in the cohort are followed during routine outpatient visits, regardless of their CD4 cell count, HIV viral load, or ART status. Data collected annually include demographic information, immunological and virological measures, serological tests for hepatitis B, hepatitis C, and syphilis, as well as laboratory, therapeutic, and clinical data. This long-term study has been enrolling patients since 2010 and continues to collect data prospectively. Participants provide data through their scheduled clinic visits, and researchers track outcomes such as the proportion of patients with undetectable HIV viral load, ART usage patterns, HCV treatment uptake and success, CD4 cell counts, and incidence of HIV-related events. The main outcome measured is the proportion of treated patients with HIV plasma viral load below 50 copiesmL, averaged over six months. The study extends through 2030, with ongoing annual monitoring and data collection as part of routine care.

Researchers are evaluating the impact on quality of life and economic outcomes of combining a scheduled consultation with a hospital clinical pharmacist and electronic patient-reported outcomes ePRO monitoring for patients undergoing oral cancer therapies. The study focuses on patients with metastatic or locally advanced cancer starting oral therapy, addressing issues like drug interactions, side effects, and the gap between patient and physician reporting of symptoms. Improving detection of drug interactions and monitoring toxicities aims to enhance patient care and treatment adherence. Participants are randomly assigned to either a group receiving proactive medication assessment with the hospital pharmacist plus follow-up using the THESS electronic monitoring system or to standard care without these interventions. The study involves scheduled consultations to detect potential drug interactions and inform patients about their treatments, alongside weekly symptom reporting via the THESS app. This approach integrates therapeutic follow-up and clinical information collection to better manage treatment toxicities. During the study, patients will be closely monitored for changes in quality of life, toxicity levels, treatment adherence, and patient satisfaction over up to 18 months. Assessments include patient-reported symptoms, medication adherence, prescription changes, and economic evaluations such as cost of care and budget impact analysis. Data collection occurs regularly at intervals up to 18 months, allowing researchers to measure time until a 5-point decrease in quality of life and other health outcomes, ensuring comprehensive monitoring throughout the study period.

Researchers are conducting a global, single-arm, non-controlled observational study to assess the long-term performance, safety, and usability of Teknimeds range of sports surgery products. These devices, including bioabsorbable interference screws, pins, non-absorbable sutures, and anchors, are commonly used in orthopedic surgeries such as knee ligament reconstructions, shoulder repairs, and foot surgeries. This study aims to collect real-world safety and efficacy data to better understand these products behavior over time. The study involves patients undergoing orthopedic surgeries using various Teknimed devices like EUROSCREW NG, ISOFIX, SUTURLINK, ALINKS, and bioresorbable pins. Patients include those having surgeries on knee anterior and posterior cruciate ligaments, ankle, shoulder, and foot. The study collects data both retrospectively from surgeries performed since January 2016 and prospectively from patients planned for surgery with these products. Treatments are delivered as part of standard orthopedic surgical procedures. Participants will be followed according to local medical care standards, with assessments including joint function evaluation for up to 4 years and adverse event monitoring for 5 years. Secondary measures include pain levels, pain medication use, patient satisfaction, quality of life, radiological outcomes, and device usability during surgery. Data collection occurs during routine follow-ups and includes retrospective and prospective clinical information, ensuring comprehensive long-term monitoring of these orthopedic devices.