There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.
This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study. Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4). It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT. The TARGIT C study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines. Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome. The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a pre-pathology stratum. It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.
The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion.
Multicentric epidemiological non-comparative study in France characterising evolution of anal Human papillomavirus (HPV) infection and related lesions and evaluating markers associated with the observed evolution. Estimated enrolment: 500 Principal Outcomes - Detection of high-grade cytological and histological anal lesions by high resolution anoscopy - Spontaneous regression of high-grade anal lesions - Detection of anal HPV infection Intervention (procedure): - Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits) - Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits) - High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits) Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA): - anal biopsy(ies) during HRA Only if high-grade lesion: - HRA biannually
The goal of this study is to assess the effect of a therapeutic education program in addition of a hydrotherapeutic cure on obese patients. The therapeutic education program at the thermal baths of Brides-les-Bains is composed of a dietary follow-up, a physical activities program, working group.
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric subjects with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306.
Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.
To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS).
The link between precarious situations and health conditions are more described in previous study. Precarious situations are more frequent and complex especially in rural areas. There are recognized like a risk factor of complications during pregnancy and delivery. It's necessary to describe antenatal cares for rural women in precarious situations to prevent those situations, to understand their difficulties in order to reduce inequalities and health spending. The aim of the PRUGNANCY study is to understand the difficulties of rural parturient women and the strategies developed to overcome them. Recognized earlier precarious situations and valorized General Practitioners and restore them to the follow-up or parturient women.
There is an increasing number of reports describing the existence of a proportion of prostate cancer patients who present with a reduced number of metastases (<5 lesions) at relapse. This oligometastatic status has also been recognized in other tumor types such as melanoma, soft tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these malignancies in that a more radical treatment such as surgical resection has been employed. Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease after biochemical treatment failure in prostate cancer. An aggressive treatment combining androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a treatment strategy may hypothetically succeed to prolong the failure-free interval between two consecutive ADT courses, or even cure selected patients with limited metastatic burden. In this study the investigators plan to assess biochemical or clinical relapse-free survival at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose conformal Radiation Therapy and LH-RH agonists.