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.
Gastrointestinal (GI) cancers account for the most common cancers. Despite recent advances in GI cancer treatments, the 5-year overall survival rate for these patients remain unacceptable, except for patients who are candidates for metastasis surgical resection. Strategies leading to a decrease of metastatic number and size will contribute to improve the probability to undergo a curative surgical procedure. Haploidentical Natural Killer (NK) cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of selected malignancies, since the failure to recognize the appropriate KIR ligand on a mismatched tumor cell can trigger NK cell elimination of that target cell. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Cetuximab, an IgG1 chimeric monoclonal antibody against colorectal cancers that expressed EGFR (epidermal growth factor receptor), improves overall survival and progression-free survival and preserves quality-of-life measures in patients with colorectal cancer in whom other treatments have failed. In an attempt to improve the outcome in GI cancers, we will conduct a phase I/II clinical trial assessing NK cell based immunotherapy. Patients with liver metastases related to a EGFR+ GI cancer, previously treated by a standard chemotherapy that did not achieve a complete response or a curative resection of residual metastases will be included in this phase I/II trial supported by the French National Institute of Cancer (INCA, PHRC 2005). This phase I/II study will involve 22 patients. The main objective of this study will be to demonstrate the safety of NK hepatic intraarterial infusion in association with cetuximab. Secondary objectives will include the assessment of the clinical efficacity of this strategy.
This Study evaluates the performance (sensitivity, specificity, positive and negative predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology, microscopy and fungal culture, in a test group of 52 patients including : - patients at high-risk according to the EORTC/MSG criteria (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of allogeneic HSCT, or inherited severe immunodeficiency), - patients with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions.
The prevalence of malnutrition in hospital is very high (30 percent) with major consequences in terms of morbidity and mortality, generating significant health care costs. The positive impact of its support is demonstrated. The HAS (French High Sanitary Authority) recommends a screening of all adult hospitalized in the first 48 hours, with no consensus regarding the organization of screening within care services. Various strategies have been implemented. Although this screening is part of the nursing role, old and recent studies show that it is not done systematically and nutritional disorders are largely under-diagnosed and therefore untreated. The investigators assume that an organization of screening for eating disorders, based on a caregiver dedicated to this activity, improves the indicator IPAQSS (Indicateurs Pour l'Amélioration de la Qualité et de la Sécurité des Soins) which is an indicator for the improvement of the quality and security of care) Screening indicator of nutritional disorders Level 3, compared to an organization "classic" involving the care teams in their entirety. This indicator reflects the care system performance. In this study, patients will have no intervention. Only the organization of the care staff will be adapted but with no changes on the care of patients?
This study take place in the palliative care units of Burgundy-Franche-Comté regions and at the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide). This involves conducting interviews with patients, carers to whom the request has been expressed and a relative chosen by the patient. This study aims to describe the request over time. This will be done through two series of interviews, one as soon as it is first expressed, then one week later.
Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML. The present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.
We recently described the ROX index, defined as the ratio of SpO2/FIO2 to respiratory rate that outperformed the diagnostic accuracy of the two variables separately. Patients who had a ROX index ≥4.88 after 12 hours of HFNC therapy were less likely to be intubated, even after adjusting for potential covariates. Like any other scoring system, an independent validation of the score in a different population is necessary. We therefore undertook a multicenter, prospective study to validate the ROX index's diagnostic accuracy for determining which patients will fail on HFNC and will need to be intubated.
The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single oral doses
The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome. Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease. Based on these data, the investigators retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.
Sleepwalking (also called somnambulism) is a disorder in which only SWS is disrupted. This NREM parasomnia is characterized by inappropriate motor behaviors, usually initiated during arousal from SWS, that induce psychological distress and alter quality of life, leading to fatigue, excessive daytime sleepiness, and objectively impaired vigilance in the morning. The pathophysiology of sleepwalking remains poorly understood. Sleepwalkers had difficulty maintaining stable, consolidated sleep and experienced more arousals and microarousals, specifically from SWS, leading to increased NREM instability, especially during the first sleep cycles. The brain is partially awake, resulting in behavioral manifestations, and partially in NREM sleep, resulting in no conscious awareness of actions. A Single Photonic Emission Computed Tomography (SPECT) study of one sleepwalking episode found increased activation in the posterior cingulate cortex and cerebellum, with deactivation in the frontoparietal associative cortices. Data from intracerebral EEGs during confusional arousals confirmed both local arousal of the motor and cingulate cortices and increased delta activity in the frontoparietal associative cortices. The investigators thus proposed a controlled study of SPECT imagery in 24 sleepwalkers (12 SPECT during a SW episode and 12 SPECT during slow wave sleep and 24 during wakefulness) and 12 controls (during slow wave sleep and wakefulness). SW episodes will be elicited by sleep deprivation condition associated with forced arousal (auditory stimulus). The comparative analyses of SPECT acquisitions between different states (wakefulness, slow wave sleep and SW) and populations (sleepwalkers versus controls) will provide new insights about the complex pathophysiology of SW episodes.