Brive La Gaillarde

Researchers are evaluating the safety and performance of Teknimed's arthroplasty products, including CEMFIX e and GENTAFIX e bone cements and the CEMSTOP e cement restrictor, which have been used for over 20 years. These products are designed to help fix joint prostheses to bones during joint replacement surgeries, which commonly address conditions like osteoarthritis, osteonecrosis, and trauma. The study focuses on collecting real-life long-term safety and effectiveness data through a retrospective and prospective observational design. The study involves patients undergoing cemented joint arthroplasty procedures using Teknimed's bone cements and cement restrictor. It is a global, multicenter, single-arm, non-controlled study where participants will be followed according to local medical care standards. Both patients who have already had surgery with these products since January 2016 and those scheduled for such procedures are included. Participants will be monitored for up to 15 years, with primary outcomes including survival rate of the device and rates of superficial or deep postoperative infections. Data collection includes clinical follow-up visits and routine medical care assessments. The study aims to confirm the long-term safety and performance of Teknimed arthroplasty products in real-world use.

Minimally invasive surgery has greatly changed surgical practices since the 1980s, especially in urology where laparoscopy and robot-assisted surgery have advanced treatment of conditions like prostate cancer. In France and other countries, robotic surgery became widespread without strong studies confirming its benefits or guidelines on quality and access. This trial aims to carefully evaluate robot-assisted prostate removal compared to traditional laparoscopic and open surgery techniques to provide clear evidence for patients and healthcare decision-makers. Participants will undergo radical prostatectomy using one of three approaches: robot-assisted laparoscopy, conventional laparoscopy, or open surgery (laparotomy). Urinary and erectile functions will be assessed before and after surgery to compare outcomes across the three groups. This large prospective study is conducted at multiple centers to gather reliable data on the benefits and impacts of each surgical method. During the study, patients will be evaluated for urinary function using the EPIC 50 score 45 days after surgery. Researchers will also assess erectile and urinary functions before and after the prostatectomy. The study focuses on understanding how each surgical technique affects recovery and function, helping to inform patients and health authorities about the real advantages of robot-assisted surgery. Participants must be hospitalized for planned radical prostatectomy and will be monitored throughout their treatment and recovery.

Researchers are evaluating whether Esmolol, a cardioselective beta-blocker, can be an effective alternative to Sufentanil, a commonly used morphine-based painkiller, during general anesthesia for outpatient laparoscopic cholecystectomy with orotracheal intubation. This phase 4 study aims to compare these two drugs in terms of post-operative recovery quality and pain control, addressing concerns about morphine-related side effects such as nausea, vomiting, confusion, itching, and addiction. Esmolol's rapid clearance from the body may offer advantages in outpatient surgery settings. The study will enroll 120 patients over 18 months at two hospitals in France. Participants will be randomly assigned to receive either Esmolol or Sufentanil during their surgery. Both groups will undergo general anesthesia with orotracheal intubation. The study includes an inclusion visit during the anesthesia consultation, a surgery day visit for eligibility confirmation and randomization, and a follow-up telephone visit the day after surgery to assess recovery quality and painkiller use. Participants will be closely monitored through vital signs recorded during surgery and questionnaires assessing their quality of recovery two days after surgery. Data collected includes demographics, medical history, and clinical measures such as heart rate and blood pressure. The primary outcome is the difference in quality of recovery measured by a questionnaire two days post-operation. Safety and adherence are monitored throughout, and patients can withdraw at any time without affecting their medical care.

Researchers are investigating the interactions between pregnancy and multiple sclerosis (MS), including related disorders such as neuromyelitis optica (NMO) and myelin oligodendrocyte glycoprotein (MOG)-antibody related disorders. This national prospective study aims to better understand how pregnancy impacts MS and associated conditions, focusing on questions about disease-modifying drugs (DMDs), breastfeeding, locoregional analgesia, and the short- and long-term effects on both mother and child. The study is nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort and includes patients across various MS-related diagnoses without age limits. Participants will not receive any experimental treatment but will be observed throughout pregnancy and up to one year after delivery. Their children will be followed until six years of age. The study collects data on pregnancy-related factors, use or discontinuation of DMDs, breastfeeding practices, and analgesia methods during delivery. Neurologists and researchers will gather information on the course of MS and related disorders before, during, and after pregnancy. During the study, participants will be monitored for treatment-related adverse events during pregnancy and the postpartum period, with assessments continuing for up to two years. Data collected will include clinical evaluations and long-term follow-up of both mothers and children. This comprehensive observation aims to provide clearer answers about the safety and impact of therapies and pregnancy-related factors on MS and related neurological conditions over time.

Researchers are investigating the best target for mean arterial pressure (MAP) to improve brain function after out-of-hospital cardiac arrest, a critical condition with low survival rates. Brain injury after cardiac arrest is a major cause of death and disability, often worsened by low blood flow to the brain early after circulation returns. This study compares a standard MAP target of at least 65 mmHg with a higher target of at least 90 mmHg to see if raising MAP can improve neurological outcomes within 180 days after the event. Participants in the study will be randomly assigned to receive norepinephrine to maintain either a MAP of at least 65 mmHg or a MAP of at least 90 mmHg for the first 24 hours after inclusion. This intervention aims to ensure sufficient blood flow to the brain while avoiding potential risks from too high blood pressure. The study monitors the effects of these two MAP targets during the critical early period after cardiac arrest. During the study, patients will be closely monitored in intensive care with assessments focused on their neurological function 180 days after the cardiac arrest. Researchers will evaluate the proportion of patients who achieve good neurofunctional outcomes. The study includes careful follow-up and recording of clinical data to understand the impact of different MAP targets on survival and brain recovery after this serious event.

Researchers are evaluating the effect of Interferon-gamma, a standardized immunotherapy, on preventing secondary infections in patients with sustained immunosuppression acquired in the ICU. This phase 3 randomized trial aims to determine if Interferon-gamma reduces the incidence of secondary infection episodes at three months, lowers ICU mortality up to day 90, shortens ICU and hospital stays, promotes biological immune restoration by day 10, and is cost-effective compared to a placebo. Participants will receive either Interferon Gamma 1-b injections or placebo injections for up to 5 times between day 1 and day 9. The study medication is given under the same conditions for both groups. After treatment, participants are monitored daily until ICU discharge and then followed up at days 30, 60, and 90 to assess outcomes and safety. During the study, patients will undergo regular evaluations including daily monitoring in the ICU and follow-up visits after discharge. Researchers will track secondary infections, mortality, length of ICU and hospital stay, immune function restoration, and economic outcomes. The main outcome measure is the occurrence of secondary infection episodes by day 90. Safety and adherence are closely observed throughout the participation period.

Researchers are evaluating whether giving amiodarone for 72 hours can reduce the risk of death or severe dangerous heart rhythms in critically ill patients admitted after an out-of-hospital cardiac arrest with a shockable heart rhythm and a confirmed or suspected cardiac cause. This phase 3 study focuses on improving outcomes within 30 days after treatment starts, addressing a critical period following cardiac arrest where complications are common. Participants receive an initial 300 mg loading dose of amiodarone over 30 minutes in a glucose solution, followed by a continuous infusion for 72 hours at a dose of 10 mg/kg per day, not exceeding 900 mg in 24 hours. The treatment is given through a central venous catheter in the intensive care unit. The study compares this preventive approach to standard care to see if it lowers the chance of death or severe ventricular arrhythmias requiring urgent intervention. During the study, participants are closely monitored in the ICU with regular assessments to track heart rhythms and overall health status. Researchers measure the rate of mortality and severe ventricular arrhythmias within 30 days from the start of treatment. Safety and treatment effects are carefully observed during this critical period to determine if prophylactic amiodarone can improve patient outcomes after cardiac arrest.

Researchers are conducting the Dataids cohort, a long-term prospective study involving over 30,000 HIV-infected patients receiving care at more than 15 HIV centers across France. The study aims to monitor clinical practices, track changes in the course of HIV and related infections, and evaluate factors influencing the clinical, immunological, and virological progression of HIV. It also focuses on assessing antiretroviral therapy (ART) effectiveness and monitoring hepatitis C virus (HCV) treatment outcomes. Participants in the study include HIV-1 infected patients regardless of their CD4 cell count or ART status. Data collection occurs as part of routine outpatient clinic visits, with annual gathering of demographic, immunological, virological, serological, laboratory, therapeutic, and clinical information. The cohort has been ongoing since 2010, reflecting real-world clinical care and treatment patterns in France. Throughout the study, researchers track participants’ HIV plasma viral load to evaluate treatment success, specifically measuring the proportion of patients with viral loads below 50 copies/mL over an average of six months from enrollment. Data on co-infections such as hepatitis B and C, as well as syphilis, are also collected. This observational design allows ongoing surveillance of HIV infection trends and treatment effectiveness, supporting improved care quality for HIV patients in France.

Researchers are exploring how combining proactive medication assessment by clinical pharmacists with electronic monitoring of side effects affects the quality of life and economic outcomes for patients undergoing oral cancer therapy. Oral therapies, which make up 75% of cancer treatments, raise specific challenges such as drug interactions and side effects that can impact treatment effectiveness and patient well-being. These side effects are often underreported during physician visits, so using electronic patient reported outcomes (ePRO) may provide a better understanding and management of toxicities. The study involves a care pathway that includes scheduled consultations with hospital pharmacists to identify potential drug interactions and educate patients about their treatments to improve quality of life and adherence. Patients will also be followed up by nurses and receive weekly symptom notifications through the THESS application, where they report any side effects experienced over the past week. This approach aims to closely monitor and manage toxicities associated with oral cancer therapies. Participants will be involved in ongoing assessments including symptom reporting via the electronic system, consultations, and follow-ups to monitor side effects and drug interactions. Researchers will measure the time until a 5-point decrease in quality of life between groups, with follow-up lasting up to 18 months. The study also aims to estimate the economic impact of this combined care approach, ensuring continuous monitoring and support throughout the treatment period.

It is admitted that: * Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction, * Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes, * Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures, * Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis. Furthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined. This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use. Studied products include - but are not restricted to - the following TEKNIMED products: * EUROSCREW® NG * ISOFIX® * SUTUR'LINK® * A'LINK'S® * BIORESORBABLE PINS And following associated TEKNIMED instrumentation: * ACL Instrumentation * A'LINK'S® Instrumentation * STAINLESS STEEL PINS