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NCT ID: NCT02055937 Terminated - Breast Cancer Clinical Trials

Immediate Implant Breast Reconstruction

ISIS
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to study the impact of the immediate implant breast reconstruction for patients with mastectomy and postoperative chest wall radiotherapy

NCT ID: NCT02055924 Terminated - B-cell Lymphoma Clinical Trials

Bruton's Tyrosine Kinase (BTK) Inhibition in B-cell Lymphomas

BIBLOS
Start date: May 26, 2014
Phase: Phase 1
Study type: Interventional

This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients with B-cell malignancies. This dose escalation will be followed by an exploratory expansion phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C). During Part 1 Dose Escalation, the "3+3" design will be applied. Three doses of ibrutinib (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation Committee. Dose escalation will begin at dose level 1 = 420 mg. The dose escalation will be performed for two types of associations in five separate groups : - Group A : ibrutinib D1-D21+ R-DHAP - Group B : ibrutinib D1-D21 R-DHAOx - Group Abis : ibrutinib D5-D18+ R-DHAP - Group Bbis : ibrutinib D5-D18 R-DHAOx This dose escalation will be followed by an exploratory expansion phase in the group Bbis plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C. Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion of each patient.

NCT ID: NCT02055846 Terminated - Clinical trials for Androgen-independent Prostate Cancer

Analysis of the Mechanisms of Actions of Heat Shock Protein (Hsp27) Responsible of the Androgen-independent Evolution in Prostate Cancer

Start date: March 2012
Phase: N/A
Study type: Interventional

Prostate cancer (PC) represents one of the most common cancers in industrialized countries. Patients with localized disease may be treated with surgery or radiation, while androgen ablation is used as first-line therapy in patients with metastatic disease. While most patients initially respond well to this hormonal therapy, they most ultimately become unresponsive and recur within 2 years as androgen-independent prostate cancer (AIPC). Recently, docetaxel-based regimens have demonstrated improved survival in men with AIPC in two different, large, phase III studies. However, the median overall survival was prolonged for only 2 or 3 months. Androgen independent (AI) progression involves variable combinations of clonal selection, adaptive up-regulation of anti-apoptotic genes, ligand-independent androgen receptor (AR) activation, alternative growth factor pathways, and immune system escape. Additional therapeutic strategies targeting molecular mechanisms mediating resistance, combined with immunotherapy must be developed. One strategy to improve therapies in advanced PC involves targeting genes that are activated by androgen withdrawal, either to delay or prevent the emergence of the resistant AI phenotype. Recently, a scientist,identified Heat Shock Protein (Hsp27) as a highly over-expressed gene in AIPC. Hsp27 knockdown using antisens oligonucleotides (ASO) and small interfering RNA (siRNA) increased apoptotic rates and enhanced hormone- and chemo-therapy in PC. She developed and patented a 2nd generation ASO targeting Hsp27 that has been licensed (investigational drug called OGX-427) and clinical trials phase I/II is currently in process in PC. Despite OGX-427 efficiency, the functional role of stress induced Hsp27 in castration or chemotherapy-induced apoptosis remains undefined. The purpose of this study is to elucidate the pathways leading to Hsp27 action in androgen-independent prostate cancer in order to 1/ Increase the pharmacological safety of OGX-427 and 2/find new specific therapeutic targets and treatment strategy for androgen-independent prostate cancer .

NCT ID: NCT02055781 Terminated - Clinical trials for Primary Myelofibrosis

Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia

PAC326
Start date: February 2014
Phase: Phase 3
Study type: Interventional

Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.

NCT ID: NCT02054884 Terminated - Clinical trials for Merkel Cell Carcinoma

F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma

Start date: October 25, 2013
Phase: Phase 2
Study type: Interventional

There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have been conducted to establish standard of care. Despite a sizable number of objective responses induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival has never been demonstrated. This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are not amenable to surgery. A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A), and 45 patients will receive paclitaxel monotherapy (Arm B).

NCT ID: NCT02048189 Terminated - Clinical trials for Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy

Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes

TRICIDIA
Start date: March 8, 2012
Phase: Phase 4
Study type: Interventional

This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®. In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.

NCT ID: NCT02048033 Terminated - Clinical trials for the Management of Weight Regain After Gastric Bypass by Endoscopic Suturing

Assessment of the Overstich Technique for the Management of Weight Regain After Gastric Bypass.

Start date: January 3, 2014
Phase: N/A
Study type: Interventional

Prospective multicenters randomized study to compare the efficiency and the socioeconomic impact of the endoscopic management (Overstitch technique) of weight regain after gastric bypass surgery to non invasive treatment

NCT ID: NCT02044939 Terminated - Clinical trials for Stage 4 Pulmonary Sarcoidosis

Pulmonary Rehabilitation in Patients With Sarcoidosis

Start date: July 10, 2012
Phase: N/A
Study type: Interventional

The primary objective of the study is to assess the improvement of daily activity in subjects with Stage IV Pulmonary Sarcoidosis one year after the conduct of a pulmonary rehabilitation program. The secondary objectives are the following: - assess the improvement of daily activity at several times : 2, 6 and 12 months after the beginning of a pulmonary rehabilitation program - assess the improvement of exercise capacity by tests used in medical practice - assess the correlation between daily activity and exercise capacity - assess the improvement of dyspnea - assess the improvement of quality of life and psychological state

NCT ID: NCT02044822 Terminated - Clinical trials for B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion

Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

Start date: August 6, 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

NCT ID: NCT02042573 Terminated - Depression Clinical Trials

Preliminary Study to Investigate the Effect of rTMS and SSRI Antidepressants on Leukocyte Expression of the C-FOS and DUSP1 Genes in Patients Treated for Depression

TMSFOS
Start date: November 25, 2013
Phase: Phase 4
Study type: Interventional

Low frequency rTMS (repetitive Transcranial Magnetic Stimulation) for the treatment of patients with depression, is responsible for a decrease in the expression of the C-FOS and DUSP1 genes in peripheral blood leukocytes. The decrease in C-FOS expression could be explained by the inhibiting effect of low-frequency rTMS (in contrast, high-frequency rTMS causes activation of the cerebral cortex) [Rossi, 2009]. This genetic effect could correlate with the antidepressant effect [Hausmann, 2000]. According to this hypothesis, the genetic effect related to medical antidepressant treatments deserves to be studied because we could observe: - either a decrease in the expression of the C-FOS and DUSP1 genes related to the antidepressant effect of the medical antidepressant treatment, - or an increase in the expression of the C-FOS and DUSP1 genes related to cerebral activation due to the medical antidepressant treatment. In summary, we wish to determine the validity of this hypothesis by comparing the genetic effect of rTMS with that of medical antidepressants to know if: - this genetic effect is specific to rTMS or common rTMS and medical antidepressants - this effect correlates with the clinical improvement induced by rTMS and by medical antidepressants - this early modification in the C-FOS and DUSP1 genes may be predictor of the therapeutic response to rTMS and antidepressants (early decrease in gene expression) - the absence of any decrease or increase in C-FOS and /or DUSP1 expression is a predictor of therapeutic resistance to rTMS and/or medical antidepressants.