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NCT ID: NCT06093724 Recruiting - Transgenderism Clinical Trials

Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)

TRANSPELV
Start date: September 8, 2023
Phase: N/A
Study type: Interventional

The research consists of adding to the usual MtF transgender patient undergoing vaginoplasty care course, static and dynamic perineo-pelvic MRI before, and at 6 and 24 months. The aim is to assess perineo-pelvic static's evolution, based on the appearance of a rectocele.

NCT ID: NCT06093269 Recruiting - Clinical trials for Infection, Bacterial

Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL)

CEFAZODIAL
Start date: November 20, 2023
Phase: Phase 4
Study type: Interventional

In chronic hemodialysis patients, bacteremia is most commonly caused by dialysis catheter infections. It is estimated that the vast majority (52-84%) of these infections are due to Gram-positive cocci, particularly Staphylococcus aureus (21-43%). Penicillin M (oxacillin and cloxacillin in France) is the reference beta-lactam for the treatment of invasive methicillin-sensitive S. aureus (MSSA) infections, but has not shown a prognostic benefit in large retrospective cohorts comparing penicillin M and cefazolin, at the expense of more frequent adverse events. Dosage in the chronic hemodialysis population is unclear because it is based on old studies.

NCT ID: NCT06092879 Recruiting - Clinical trials for Chronic Myeloid Leukemia

Asciminib Prospective Non Interventional Study as 3rd Line Therapy or More to Treat Adult Patients With CML- CP in Real World Setting in France

ASSURE-3
Start date: March 6, 2024
Phase:
Study type: Observational

The purpose of this study is to enhance the knowledge on asciminib treatment in a broader and real-life population by collecting additional data to characterize the treatment patterns of patients treated with asciminib, with a primary objective represented by maintenance on treatment at 12 months.

NCT ID: NCT06091865 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma (DLBCL)

A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

OLYMPIA-3
Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B-cell lymphoma (DLBCL) that have not been treated before (called "previously untreated"), have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"). This study will be made up of Part 1a, Part 1b, and Part 2.The aim of Part 1a and Part 1b of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study. The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy, the current standard of care treatment approved for Non-Hodgkin's lymphoma (NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug when combined with chemotherapy - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) - The impact from the study drug on your quality of life and ability to complete routine daily activities

NCT ID: NCT06091306 Recruiting - Anorexia Nervosa Clinical Trials

Qualitative Evaluation of Change Processes in Multifamily Therapy for Adolescents With Anorexia Nervosa

QUALI-TMF-TCA
Start date: December 1, 2023
Phase:
Study type: Observational

Anorexia nervosa is a characterised disorder which forms part of the wider spectrum of eating disorders. It is a common pathology, particularly in adolescence, with a complex, severe prognosis in both somatic and psychiatric terms, and significant psychosocial consequences, particularly for family relationships. The treatment of anorexia requires a multidisciplinary team of specialists who can offer individual and family-based approaches. International recommendations highlight the encouraging results of family therapy in the treatment of anorexia nervosa in adolescence. Various types of family approach exist, including "Family Based Treatments", which are a specific but highly effective approach, particularly widespread in the United States. Multifamily therapy (MFT), which involves bringing several families together to address the problem of anorexia, has proved effective for several years now. Since January 2019, multifamily therapy has been offered to adolescents aged 12 to 18 who are being followed at the Maison de Solenn-Maison des Adolescents at Cochin hospital, for anorexia nervosa, as well as their families. Each group brings together 5 to 7 families and comprises 10 3-hour sessions, with 3 weeks between each session. 2 groups are offered per year. Multi-family therapy therefore involves 10 to 14 families per year. It complements the other approaches available in the department. To be able to describe the therapeutic processes at work in multifamily groups in order to be able to better describe our therapeutic device and envisage possible modifications. These processes would be broken down into four areas: MFT and its effects on the anorexic symptom, MFT and its effects on the family, MFT as group therapy and ways of improving the MFT system.

NCT ID: NCT06091020 Recruiting - Clinical trials for Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury

A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participants Aged 18 Years and Older With Chronic Nerve Pain After Shingles or Nerve Injury

PaiNT
Start date: November 22, 2023
Phase: Phase 2
Study type: Interventional

In this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with NT 201 or placebo. The purpose is to measure the decrease of nerve pain with NT 201 compared to placebo. Trial details include: - Trial duration: 22-23 weeks; - Treatment duration: 1 injection visit with a 20-week follow-up period; - Visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).

NCT ID: NCT06090539 Recruiting - Clinical trials for Relapsed/Refractory Non-Hodgkin Lymphoma

A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

Start date: December 29, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.

NCT ID: NCT06089850 Recruiting - Transplantation Clinical Trials

Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

HAPLOGREF
Start date: January 22, 2024
Phase: N/A
Study type: Interventional

Allogeneic hematopoietic stem cell transplantation (allo-HSC) is currently one of the only curative treatments for haematological malignancies with a poor prognosis, the realization of which presupposes the identification and availability of a compatible donor. In recent years, haploidentical transplants have been developed, a reliable alternative for patients who do not have 100% compatible donors. The development of haplo-identical transplants leads to an exponential increase in the use of intra-family donation. Intrafamilial donation of hematopoietic stem cells (HSC) has the advantages of lower financial cost and faster availability of the graft, thus avoiding the risk of relapse before the procedure. Nevertheless, intrafamilial donation raises clinical and ethical questions. Indeed, the psychological impact of intra-family donation on the donor cannot be overlooked. Thus, in the context of the development of haplo-identical transplants, measuring the impact of donation on donors (ascendants and descendants) will make it possible to assess the relevance of taking psychosocial aspects into consideration in the choice of donors, to assess the psychological impact of haplo-identical donation and to offer psychological support adapted to donors.

NCT ID: NCT06089759 Recruiting - Lipodystrophy Clinical Trials

Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment

Start date: August 30, 2023
Phase:
Study type: Observational

The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month after intervention.

NCT ID: NCT06088927 Recruiting - Clinical trials for Conduction System Pacing

Long-term Outcomes of Conduction System Pacing: a National Multicenter Observational Study - NORMAND'HIS / STIMU'HIS

STIMU'HIS
Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

This prospective multicenter registry will evaluate the long-term electrical, echocardiographic, and clinical outcomes of conduction system pacing (CSP). There is currently limited data in the literature regarding the long-term results and benefits of CSP. The long-term maintenance of conduction system (His bundle or Left Bundle Branch) capture and physiological ventricular activation is an essential prerequisite for the expected benefits of this technique. There is currently no prospective study evaluating the preservation of CSP during long-term follow-up. The design of the present study will allow reliable evaluation of CSP maintenance at 2 years follow-up. The prospective collection of electrical data (pacing thresholds, impedance, R wave sensing) during pacemaker follow-up visits will confirm thresholds stability over the long term. The incidence of atrial fibrillation episodes will also be precisely evaluated and will provide new information. Although pathophysiological studies have demonstrated less impairment of left atrial function with conduction system pacing, there is currently no data on the incidence of atrial fibrillation in patients implanted with a CSP pacemaker. Echocardiographic data will be prospectively collected in order to analyse the evolution of left ventricular ejection fraction (LVEF) after CSP. This systematic follow-up is rarely found in CSP studies, often retrospective, with significant missing echocardiographic data. The hypothesis is that patients benefiting from CSP will not develop the deleterious effects demonstrated with conventional right ventricular pacing, such as left ventricular dilation and LVEF impairment. Inter- and intraventricular asynchrony criteria will also be systematically evaluated during follow-up echocardiography.Finally, this prospective cohort will also systematically collect clinical follow-up data (hospitalizations for heart failure and NYHA stage).