Saverdun, France

Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease

Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis

A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Complicated Urinary Tract Infection

Diagnosis, Treatment, and Outcome Assessment of Septic Cardiomyopathy Using an Integrated Mathematical Model

This multicenter, prospective observational study will enrol adult patients treated for sepsis or septic shock in the intensive care unit (ICU). Eligible patients will be identified based on predefined inclusion and exclusion criteria and enrolled in the study after obtaining informed consent. The primary transthoracic echocardiography will be performed within 48 hours of enrollment to gather detailed echocardiographic data, while key hemodynamic measurements will be recorded simultaneously. A second transthoracic echocardiography will be conducted within 10 days of the initial evaluation. This follow-up assessment will occur during continued ICU care after discontinuation of vasopressor therapy or during hospitalization in the general ward, depending on the patient's clinical progression. The echocardiographic and hemodynamic parameters from both the initial and follow-up evaluations will be input into a mathematical formula designed to integrate these data into a single cardiovascular estimate. This integrated model will then be used to assess its ability to predict patient outcomes. Following hospital discharge, patients will be followed for up to one year. During this period, a long-term follow-up assessment will be conducted, during which patients will complete the SF-36 quality of life questionnaire. This follow-up will assess patients' overall health, functional status, frequency of healthcare visits, and need for nursing care. These data will provide insights into the long-term impact of sepsis and septic cardiomyopathy on survivors beyond the acute phase of their illness. This study will evaluate whether the use of an integrated model that combines clinical parameters with echocardiographic measurements can improve the accuracy of diagnosing septic cardiomyopathy and provide valuable predictions of clinical outcomes. Additionally, the study will assess the course of septic cardiomyopathy and its impact on one-year follow-up outcomes, including patient quality of life. A broadly applicable diagnostic approach could allow for timely treatment adjustments, reduce the burden of sepsis-related complications, and improve overall patient outcomes.

Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.

Inclusion and exclusion criteria Inclusion criteria Patients treated with CartiONE for knee cartilage lesion more than 6 months prior to inclusion in this study. The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index knee surgery report, and posttreatment observations and re-intervention reports, if applicable. Exclusion criterion Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation. Statistics This is a retrospective, open label, non-randomized, single arm trial. Since different questionnaires for effectiveness and for quality of life (e.g., KOOS, EQ-5D,...) may have been used, the total score of the questionnaires ranging from the minimum total score (i.e. 0 or 1) to the maximum total score will be transformed into the range from 0 respective 1 to 100. Now they can be combined across patients and effectiveness questionnaires or across patients and quality of life questionnaires. Details will be provided in the Statistical Analysis Plan. There are two co-primary endpoints: Primary endpoint safety: Adverse events with particular focus on Treatment failure rate and on other AESIs Primary endpoint effectiveness: MOCART sub-score 1 "Volume fill of cartilage defect" Efficacy/Effectiveness: Key secondary endpoints: Non-inferiority in MOCART/MOCART 2.0 total scores when measured at two different visits, i.e., at the reference visit and later. Non-inferiority in mean "Radiologist's overall knee status assessment" when measured on a scale from 0 (extremely bad) to 100 (extremely good) at two different visits, i.e., at the reference visit and later. Other secondary endpoints: Improvement in other effectiveness questionnaire total scores Improvement in quality-of-life total scores Improvement in other questionnaires when applicable Exploratory endpoint: "Radiologist's overall knee status assessment" on a scale from 0 (extremely bad) to 100 (extremely good) of the two readers.

Impact of Knee Extension Brace on Quadriceps EMG During ASLR

The study will be conducted on a group of healthy individuals aged 18 - 35 years. After an interview confirming that the subject does not have exclusion criteria and written consent to participate in the study, anthropometric measurements will be taken of height and weight using a scale and tape measure. The subjects will be informed in detail about the procedure and the form of the measurements, the way in which they are to be taken, and will be familiarised with the the measuring instruments and their principles of operation. Then, in accordance with the study protocol, specific measurements will be taken of the rectus femoris, medial vastus and lateral vastus muscles using surface EMG of a non-invasive nature. Study participants will undergo the following measurements: 1. Measurement of the MVC (maximum voluntary contraction) of the quadriceps of the thigh, in a sitting position with the lower leg flexed to 90 degrees. 2. Measurement of muscle activity during elevation of the straightened lower limb in a supine position without an orthosis. 3. Measurement of muscle activity during straight leg raise in supine position with knee brace. Ad.a. Measurement of quadriceps excitability of the dominant lower limb using surface EMG in a seated position with the trunk stabilised and the lower leg flexed to 90 degrees, stabilised in the distal part (without taking the foot) against a stationary object so as to execute maximal volitional isometric quadriceps muscle tension. Upper limbs crossed over the chest. Ad.b. Measurement of right quadriceps excitability using surface EMG in supine position without orthosis. The subject raises the test limb by touching the anterior surface of the tibia to a pole set at 20 cm at the command 'raise leg', then lowers the limb at the command 'lower leg'. During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times. Ad.c. Measurement of quadriceps excitability of the dominant lower limb using surface EMG in supine position with knee extension brace on. Measurement performed in three variants: 1. The test subject raises the test limb by touching the front surface of the tibia to a pole set at a height of 20 cm on the command 'raise leg', then lowers the limb on the command 'lower leg'. During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times. 2. The test subject is asked to apply maximum tension to the quadriceps (thigh muscle) (command 'press the knee against the ground, bring the toes together, straighten the foot and flex the quadriceps maximally"), then maintaining the tension he/she raises the limb touching the front surface of the tibia to the pole placed at the height of 20 cm on the command "raise the leg", then lowers the limb on the command "lower the leg". During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times. 3. Before the test, the test subject is verbally instructed to 'Try, despite the orthosis holding you upright, to bend the knee and raise the leg so that the quadriceps do not tense'. Then, on the command 'raise leg', the test subject raises the limb by touching the front surface of the tibia to a pole set at 20 cm, on the command 'lower leg' he lowers the limb. During the task there is a 1 second moment of keeping the leg straight as the tibia touches the pole. This activity is repeated three times. The time for the full test is approximately 15-20 minutes per participant. Statistical analysis will be performed using Statistica and/or JASP software. The study will be carried out with a minimum of 20 adults aged 18 - 35 years. The exact number of participants in the study, will be determined after performing an a-priori sample size estimation after collecting data from the first 10 people examined. Eligibility of subjects will include a subject and physical examination by a physiotherapist. Inclusion criteria: age between 18-35 years, no contraindications to physical exercise, ability to perform the required commands without pain or discomfort, full range of motion of the knee joint. Exclusion criteria: those with a history of knee and/or hip surgery, damage to ligamentous structures of the knee joint in the past treated conservatively or meniscus treated conservatively, muscle and tendon injury of the knee joint area in the past 3 months.

Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines