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NCT ID: NCT06149286 Recruiting - Clinical trials for Marginal Zone Lymphoma (MZL)

A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma

OLYMPIA-5
Start date: December 28, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how the combination of odronextamab and lenalidomide works compared to the combination of rituximab and lenalidomide, (the current standard-of-care treatment for FL and/or MZL). 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 in combination with lenalidomide - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the study 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: NCT06148610 Recruiting - Clinical trials for Hematologic Diseases

Evaluation of the Impact of the Use of NewSpringForMe on Transplanted Patients' Quality of Life and Support

NSFM
Start date: September 27, 2022
Phase:
Study type: Observational [Patient Registry]

Bone marrow transplantation is both a great treatment for patients with hematological diseases. It is also one of the only hopes of staying alive by "starting from scratch". It is a trying life experience, at all its stages. To support these patients and increase their success in healing and returning to a "normal life", quality of life is an ally of choice for the success of care. NewSpringForMe is an innovative tool designed for the benefit of transplant patients, through the deployment of unprecedented interdisciplinary support benefiting from the best digital technologies. This digital solution is aimed at all patients, adults and pediatrics, before, during and after bone marrow transplantation, in a long-term approach. NewSpringForMe results from the multidisciplinary collaboration of medical and paramedical experts in the field of hematology and transplantation, as well as in the field of psychology. With NewSpringForMe, each transplant patient has a personalized and scalable space accessible via a web platform, constantly offering, according to their needs and at their own pace, a range of recommendations, tools and exercises in psychology, nutrition / dietetics and physical activity, the three pillars of overall well-being. Perfectly integrated into the care pathway and the transplant protocol, from the announcement of the treatment to the long-term follow-up, several years after the intervention, NewSpringForMe complements the medical treatments provided by the medical profession: the communication of the assessments from the platform as well as patient data for caregivers allows adaptation of therapies and optimization of medical care. Thanks to the consideration of individual parameters and their evolution, and thanks to specific algorithms, each tool is adapted to the course of care and to the life of each patient, as well as to their personal health situation throughout their transplant journey. In order to demonstrate the benefits of using NewSpringForMe, the project plans to evaluate the platform and its impact on the quality of life in patients with hematological diseases. This evaluation will be done by the patients themselves and by the nursing staff. The evaluation will be carried out using a monocentric approach on a pilot cohort. The objective is to demonstrate that integrative health ensuring simultaneous care of body and mind increases the chances of success of the transplant while limiting post-transplant complications.

NCT ID: NCT06148090 Recruiting - Clinical trials for Adrenal Insufficiency

Screening for Adrenal Insufficiency During Dermocorticoid Reduction in Bullous Pemphigoid (BP)

PB-DEPIST
Start date: January 4, 2024
Phase: N/A
Study type: Interventional

The braking of the corticotropic axis is well established during the induction phase of superpotent topical corticosteroid therapy (clobetasol propionate) in bullous pemphigoid (BP). But the evolution of the corticotropic axis in the following months, especially during the tapering of topical steroids has never been studied. The objective of this study is to evaluate the prevalence of adrenal insufficiency during the topical corticosteroid therapy tapering in patients treated according to current recommendations. The secondary objectives of the study are : - to evaluate the presence of other clinico-biological signs of adrenal insufficiency (hypotension, hypoglycemia and/or hyponatremia) - to compare the characteristics of patients with adrenal insufficiency to those without in order to identify potential risk factors for adrenal insufficiency in BP.

NCT ID: NCT06147661 Recruiting - Breast Implants Clinical Trials

Primary Aesthetic Breast Augmentation: Comparative Study Between Breast Implants and Autograft of Adipose Tissue

AMEP
Start date: June 1, 2023
Phase:
Study type: Observational

The use of autograft of adipose tissue for aesthetic breast augmentation is increasing year after year. According to the latest meta-analysis of 2016, autograft of adipose tissue in augmentation mastoplasty seems to be a promising method with a satisfactory resorption volume and patient and surgeon satisfaction. However, this technique allows for small to moderate breast augmentation and is therefore not suitable for patients wanting a significant increase. Breast prostheses allow a significant increase. Numerous studies have shown an improvement in patient satisfaction and quality of life assessed using the BREAST-Q questionnaire. On the other hand, very few studies have objectively evaluated the satisfaction of patients who have benefited from an autograft of adipose tissue as part of aesthetic breast augmentation. No study has yet compared the satisfaction of patients who have benefited from breast implants or lipofilling. The aim of this study is to compare the satisfaction of patients who have benefited from breast augmentation by prosthesis or by lipofilling using a remote satisfaction interview.

NCT ID: NCT06147427 Recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

ALL Reconstruction Versus Modified Lemaire's LET in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years

ARAVET
Start date: January 16, 2024
Phase: N/A
Study type: Interventional

Anterior cruciate ligament (ACL) tears are associated with concomitant lesions of the anterolateral ligament (ALL), which increase rotatory instability of the knee. If untreated, ALL insufficiency can compromise the results of ACL reconstruction, with higher risk of iterative ACL tear or additional meniscal lesion. Several surgical techniques have been described to reconstruct the ALL. Indications are increasingly frequent and actually, consensus being young patients, patients practising pivot sports, significant rotational laxity on clinical examination with a positive pivot shift test, or in cases of iterative surgery. To date, the two most popular techniques are the Lemaire technique (use of a fascia lata strip) and LAL reconstruction plasty (use of part of an accessory hamstring tendon). The older Lemaire procedure, popularized in the 1980s has proved its efficiency in terms of biomechanics, safety and reproducibility. More recently, following a new, precise anatomical description, anterolateral ligament plasty (ALL) has been developed, which is intended to be more anatomical than Lemaire's technique, but whose clinical superiority has not yet been demonstrated. Both techniques are currently used in our department, with the choice of technique left to the surgeon's discretion. To date, no randomized prospective study has demonstrated the clinical superiority of one technique over the other with a long term follow up. The aim of this study was to compare graft survival of ALL reconstruction versus modified Lemaire LET in combination with ACL reconstruction with a minimum follow up of 2 years. Secondary aim was to compare functional outcomes between both groups.

NCT ID: NCT06146127 Recruiting - Liver Cancer Clinical Trials

Precision Medicine for Combined Hepatocellular-Cholangiocarcinoma

PREMED-CHC
Start date: January 15, 2001
Phase:
Study type: Observational

Our project is a large-scale characterisation of cHCC-CCA will allow us to determine which subsets harbor actionable gene alterations. We will also aim to improve diagnosis of this tumor type by the use of immunohistochemical biomarkers and the development of deep-learning based models able to help cHCC-CCA diagnosis. This will represent an important step towards precision medicine for the patients with this highly aggressive malignancy.

NCT ID: NCT06144840 Recruiting - Clinical trials for Erythropoietic Protoporphyria (EPP)

INcreased Sun Exposure Without Pain In Research Participants With EPP or XLP

INSPIRE
Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

NCT ID: NCT06144762 Recruiting - Pancreas Cancer Clinical Trials

Precision Imaging for Early Detection and Targeted Treatment Monitoring in Pancreatic Cancer

PANC-O-MICS
Start date: December 19, 2023
Phase: N/A
Study type: Interventional

Specifically, in this project, the objective will be developped a model to capture imaging-based tumor heterogeneity with multiscale radiomics approach by obtaining the mirror tumor image at in vivo MRI, ex vivo MRI at histology. This imaging model giving a perfect virtual histology tumor representation will be secondary implemented on routine in vivo clinical MRI for early cancer detection and treatment monitoring. Successful completion of this proposal will lead to a comprehensive non invasive characterisation of pancreatic cancer and will be a game changer in patient management.

NCT ID: NCT06144359 Recruiting - Concussion, Brain Clinical Trials

Diffusion Tensor Brain MRI in the Detection of Structural Abnormality of the White Substance in Concussion

COMMOTION
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Concussions in sports are a major public health problem because of their frequency, and are often underdiagnosed because of an unspecific clinical picture or sometimes masked by the concussion itself. Support data has been constantly evolving in recent years, including the last publication of the Berlin Consensus in 2016 specifying support in the field. However, to date, there is no tool to predict the severity of a concussion or to predict when it will return to play objectively and reliably. Brain MRI done after the head injury is most often normal. However, previous studies agree that there is a persistent electrophysiologic disturbance several weeks after the injury, and the specific pathophysiology of white matter changes after a head injury remains controversial. Diffusion tensor imaging (DTI), in addition to morphological sequences, is capable of assessing white matter microstructure and fibrous tract integrity or not. Several parameters, such as the seemingly normal white matter fractional anisotropy (FA) coefficient, the mean diffusivity and the radial diffusivity, may be altered in the aftermath of a concussion, indicating axonal damage not visible on conventional MRI sequences. Previous studies have evaluated these parameters with sometimes contradictory results: some have found an increase in AF in specific regions such as the cortico-spinal tract and the corpus callosum, others have found a decrease in AF. So far, assessment of a player's condition on and off the field after a head injury has been based on clinical criteria alone, sometimes far too subjective. The player may choose to mask their symptoms to allow them to return to the game faster, or feign more than they have. Once pathologies such as bone fractures or intracranial hematomas are ruled out by conventional imaging, there is no longer any tool for a more accurate diagnosis of possible microstructural alterations of brain tissue and for monitoring of the patient. The advent of new MRI techniques such as diffusion imaging, and particularly diffusion tensor imaging (DTI), is a promising tool to better understand white matter involvement in diffuse axonal lesions.

NCT ID: NCT06142383 Recruiting - Heart Failure Clinical Trials

A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure

Start date: December 12, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.