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NCT ID: NCT02610452 Completed - Palliative Care Clinical Trials

Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study

OUPS
Start date: March 31, 2016
Phase: N/A
Study type: Interventional

The main objective of this study was to assess changes in the quality of life of patients in a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS) before and one hour after the passage of a clown therapist .

NCT ID: NCT02610296 Completed - Clinical trials for Delayed Graft Function

QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant

ReGIFT
Start date: March 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).

NCT ID: NCT02610140 Completed - Mesothelioma Clinical Trials

Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)

Start date: December 3, 2015
Phase: Phase 2
Study type: Interventional

The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM). 210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine. Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required. Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.

NCT ID: NCT02609191 Completed - Osteodensitometry Clinical Trials

Assessment of Body Composition Via Dual-energy X-ray Absorptiometry Bone Densitometry

STRATOS
Start date: June 2016
Phase: N/A
Study type: Interventional

The main objective of this study is to validate the measurement characteristics of a new bone densitometer, the Stratos DR: - Via cross calibration to the results of body composition (BC) measurement results to those of a reference device (the "Discover A" by Hologic) in terms of body fat percentage, lean mass percentage of total body mass and for different subregions (left and right arms, left and right sides, lumbar and thoracic spine, pelvis, left and right legs, head, android area, gynecoid area, visceral region). - And by the evaluation of the reproducibility of the BC measurement results in terms of fat mass and lean mass.

NCT ID: NCT02608346 Completed - Clinical trials for Women With BRCA1 Germline Deleterious Mutation

Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)

Start date: November 2014
Phase: N/A
Study type: Interventional

BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth will be included. These patients will be followed up during 30 months (2,5 years) with mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation detection and circulating tumor cells detection (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy).

NCT ID: NCT02608333 Completed - Clinical trials for Autism Spectrum Disorder

Efficiency of Early Intervention for Autism Spectrum Disorder

IDEA
Start date: September 9, 2015
Phase: N/A
Study type: Interventional

Intervention for autism spectrum disorder (ASD) in European French-speaking countries is often heterogeneous and poorly evaluated. Six French-speaking early intervention units for children with ASD following the Early Start Denver Model (ESDM) have been created since 2011 with the common aim to evaluate effectiveness and cost-efficiency of the ESDM applied to the European French-speaking public health system. In those units, Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery. The first aim of the investigators study is to evaluate the effectiveness of ESDM intervention 12 hours per week during 2 years on the global development of children with ASD compared to the interventions commonly available in the community.

NCT ID: NCT02608255 Completed - Clinical trials for Acute Coronary Syndrome

A Prospective Pilot Study to Evaluate a New Marker of Ischemia in Chest Pain Triage

Start date: January 2016
Phase: N/A
Study type: Interventional

A Single-center prospective pilot study enrolling chest pain patients. CD 26 measurement will be performed and compared to troponin µs for early triage of these patients. This novel biomarker of myocardial ischemia (CD26) will be measured at the time of first medical contact (T0) and after 30 min simultaneously o troponin Ic. All patients aged over 18 years with chest pain which may be related to acute coronary syndrome requiring pre hospital medical contact through the Emergency Medical Service.

NCT ID: NCT02608203 Completed - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumors

[68 Ga]-DOTANOC PET/CT in GEP-NETs

GEP-NOC
Start date: May 26, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Somatostatin receptors are overexpressed in GEP-NETs and can be visualized in vivo by radiolabeled somatostatin-analogs. During the last decades, conventional scintigraphy using 111In-DTPA-Octreotide (often named somatostatin receptor scintigraphy or SRS) was considered as the gold standard nuclear imaging technique in the evaluation of GEP-NETs. However, SRS may be suboptimal in this clinical setting because of the low intrinsic resolution of the technique and its selectivity for SST2 only. Its overall sensitivity is estimated to 60-70% (per lesion analysis), even when using the most recent SPECT-CT cameras. MRI have also a higher sensitivity than CT and SRS for the detection of liver metastases from GEP-NETs. In recent years, positron emission tomography (PET) imaging, a high resolution and sensitive technology, has gained an increasing role in oncology. It has also been evaluated in GEP-NETs with somatostatin agonists (SSTa) radiolabelled with Gallium-68 [68Ga], a positron emitter with very promising results. Its diagnostic sensitivity is clearly superior to SRS and many European centers have already replaced SRS by [68Ga]-PET-SSTa. Currently, three different [68Ga]-coupled peptides can be used in trials: DOTA-TOC, DOTA-TATE and DOTA-NOC with excellent affinities for SST2 (IC50: 2.5; 0.2 and 1.9 nM, respectively). Sensitivities of DOTA-TOC and DOTA-TATE PET/CT are quite similar. [68Ga]-DOTANOC which also binds to SST5 was recently found to detect significantly more lesions than the SST2-specific radiotracer [68Ga]-DOTATATE in patients with GEP-NETs but this requires further evaluation. It is therefore important to determine the interest of [68Ga]-DOTANOC combined with the standard diagnosis strategy in GEP-NETs and evaluate medicoeconomic impact of adding [68Ga]-DOTANOC in the work-up of patients. The investigators hypothesis is that [68Ga]-DOTANOC will modify the management in at least 20% of patients in a more adapted way according to the 2012 ENETS guidelines in comparison to the decision based on the standard imaging work up (multiphasic WB CT, liver MRI and SRS). 110 patients will be included prospectively in 5 different French experienced centers (Marseille, Bordeaux, Toulouse, Paris, Clermond-Ferrand).

NCT ID: NCT02608112 Completed - Clinical trials for Rheumatoid Arthritis

Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Start date: December 31, 2015
Phase:
Study type: Observational

This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).

NCT ID: NCT02607956 Completed - HIV-1 Infection Clinical Trials

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Start date: November 11, 2015
Phase: Phase 3
Study type: Interventional

This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.