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NCT ID: NCT05740059 Recruiting - Cardiac Surgery Clinical Trials

Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery

RETSEACSII
Start date: March 14, 2023
Phase: N/A
Study type: Interventional

The goal of the clinical trial is to evaluate whether a restrictive transfusion strategy adjusted by SvO2 during the perioperative period of cardiac surgery may reduce the incidence of red blood cell transfusion. Adult patients operated on cardiac surgery will be randomly allocated into two groups, one receiving standard restrictive transfusion, the other receiving SvO2 adjusted restrictive transfusion.The proportion of patients transfused will be compared between the 2 groups.

NCT ID: NCT05739708 Recruiting - Asthma Clinical Trials

Psychological Characteristics of Patients With Severe Asthma

CATAPLASTHMA
Start date: February 15, 2023
Phase: N/A
Study type: Interventional

Like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. Approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. These patients are responsible for the majority of the overall asthma-related disease burden and also represent more than half of the total direct costs of asthma management. The scientific literature shows that personality traits, attachment type and psychological disorders will significantly influence disease coping strategies, disease experience, quality of life, adherence and therapeutic alliance. Although some data exist in asthma, there are currently no studies that have evaluated the overall psychological profile of asthma patients, and we have no data specifically on the population of severe asthmatics, who are the most difficult to manage. A better understanding of the overall psychological dimension of asthma patients will make it possible to offer therapeutic education programs that are more targeted according to the psychosocial skills of the patient and finally improve the overall management of the disease.

NCT ID: NCT05739565 Recruiting - Prostate Cancer Clinical Trials

Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients

ACTI-PAIR2
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

Despite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active. Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence. Increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care. Personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity. However, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity. This study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients: - 1-The realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers) - 2-Coaching by a peer (a patient with the same disease who has reached the WHO recommendations for physical activity), who will provide motivational follow-up - 3-Support by health professionals (attending physician) through the prescription of physical activity. The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.

NCT ID: NCT05739448 Completed - Senior Clinical Trials

Impact of an Intervention Combining Fortified Meals and Physical Activity in the Prevention of Undernutrition in Seniors

FORTIPHY
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

In the context of an aging population, preventing undernutrition and its associated risks in the elderly is a major challenge for the coming decade. Undernutrition, a recognized pathology of the elderly, has many negative impacts on the health and well-being of a person. It increases the risk of falls, fractures, pathological episodes and hospitalizations. It induces or aggravates a state of frailty and dependence, ultimately affecting the quality of life and life expectancy of the elderly. A decline in appetite and insufficient food intake are key factors in the risk of undernutrition. Contrary to popular belief, energy and protein requirements do not decrease with age and are sometimes higher for the elderly than for younger people. However, several studies have shown that caloric and protein intakes are lower than recommended for the elderly. This decrease in appetite is also accompanied by a decrease in micronutrient intake. Inadequate micronutrient intakes are associated with the onset or more rapid progression of age-related diseases. For example, inadequate intakes of lipophilic micronutrients (carotenoids, fat-soluble vitamins A, D and E, long-chain omega-3 polyunsaturated fatty acids) are associated with a more rapid onset or worsening of age-related macular degeneration (AMD). In order to prevent undernutrition, a major challenge is to allow elderly people with a poor appetite to cover their nutritional needs. Meal fortification, which consists of adding ingredients with high nutritional value to foods and beverages commonly consumed by the elderly, is a promising strategy. It allows for better adaptation to the preferences of the elderly, who are often reluctant to change their consumption habits. However, meal fortification remains largely unknown and underutilized. In parallel, several studies have shown that a high adherence to the Mediterranean diet, which is characterized by a high intake of these micronutrients, is associated with a 40% reduction in the risk of progression to AMD. Finally, there is a strong link between physical activity and nutrition to prevent muscle wasting in the elderly. Indeed, the results show that an intervention combining protein supplementation and physical exercise has a greater effect on muscle protein synthesis than protein supplementation alone. However, advancing age is frequently accompanied by a decrease in physical activity and an increase in sedentary lifestyle.

NCT ID: NCT05739383 Recruiting - Clinical trials for Primary Prevention of Atherosclerotic Cardiovascular Disease

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Start date: March 9, 2023
Phase: Phase 3
Study type: Interventional

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

NCT ID: NCT05739084 Recruiting - Clinical trials for Soft Tissue Sarcomas

Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS

RADIOSARC
Start date: November 23, 2022
Phase:
Study type: Observational

To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients

NCT ID: NCT05738668 Active, not recruiting - Clinical trials for Anti NMDA Receptor Encephalitis

Clinical-immunological Features of Anti-NMDAR Encephalitis

Bio-NMDAr
Start date: February 1, 2022
Phase:
Study type: Observational

Using a retrospective cohort of 501 patients with anti-NMDAR encephalitis to assess clinical and immunological prognostic biomarkers

NCT ID: NCT05738187 Not yet recruiting - Clinical trials for Recurrent Head and Neck Cancer

Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study

CRYORL
Start date: September 30, 2023
Phase: N/A
Study type: Interventional

In France, squamous cell carcinomas of the head and neck (SCCHN) are the 5th most common cancer. 60% of patients present with locally advanced tumors (stage III/IV), characterized by a poor prognosis (5-year survival not exceeding 60%). The standard treatment consists of either surgical removal followed by adjuvant radiochemotherapy or exclusive radiochemotherapy. In case of locoregional recurrence (about 40% of patients), salvage surgery can be proposed, allowing prolonged survival for less than one third of eligible patients. However, more than half of locoregional recurrences are unresectable. The standard treatment then consists of immunotherapy and/or chemotherapy for palliative purposes with a median survival of no more than 15 months. Stereotactic radiotherapy is another potentially curative option that allows a local control of 30-60% at 1 year, but at the cost of significant toxicity (up to 50% of grade 3-4 toxicities), thus limiting its indication. The issue of salvage treatment also applies to other rarer histological forms, including naso-sinus and salivary gland tumors, for which the probability of overall survival at 5 years does not exceed 65% due to locoregional evolution, despite advances in surgical techniques and the addition of radiotherapy. During the last two decades, minimally invasive interventional radiology techniques have been developed in the field of oncology. Among these techniques, cryotherapy is now commonly used for the treatment of several cancers. The multiplication of its indications is based on numerous clinical advantages (good post-operative analgesia, good toxicity profile, good tumor control). Cryotherapy could thus be a therapeutic alternative in head and neck cancers in recurrence situation in irradiated and unresectable territory, allowing to maintain a curative project in a higher proportion of patients and also to have a more favorable toxicity profile than re-irradiation.

NCT ID: NCT05737966 Completed - Clinical trials for First Episode Psychosis

Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist

CHECKLISTPEP
Start date: February 1, 2023
Phase:
Study type: Observational

Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care. The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP. A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions. Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.

NCT ID: NCT05737810 Completed - Type 2 Diabetes Clinical Trials

Attitudes and Unmet Needs Among Type 2 Diabetes Patients

Start date: March 27, 2023
Phase:
Study type: Observational

The main purpose of this study is to explore experiences and understand the unmet needs of people with Type 2 Diabetes (T2D) among those who are being managed with basal insulin and those who are insulin naïve in order to understand perspectives for a once weekly insulin option; including any potential barriers to being managed with insulin therapy overall. Study participants will be recruited to complete a 15-minute self-administered online survey.