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NCT ID: NCT02285179 Completed - Breast Cancer Clinical Trials

Clinical Trial to Evaluate the Safety and Effectiveness of GDC-0032 When Given Alongside Tamoxifen

Poseidon
Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is designed as a phase 1 dose escalation study followed by a randomised phase II study. The study will be performed in three different centres: Addenbrooke & Cambridge university (Cambridge, UK), Netherlands Cancer Institute Amsterdam), and Vall d'Hebron Hospital (Barcelona, Spain). Three to six patients will be followed for one completed cycle of therapy (28 days) and subsequent enrolment of new cohorts will be based on the safety assessment in that first cycle and the documentation of dose limiting toxicities. To determine the safety and efficacy of tamoxifen in combination with the isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alone.

NCT ID: NCT02285062 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma

ROBUST
Start date: February 17, 2015
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

NCT ID: NCT02284984 Completed - Clinical trials for Lupus Erythematosus, Systemic

Synergetic B-cell Immodulation in SLE

SYNBIoSe
Start date: March 2014
Phase: Phase 2
Study type: Interventional

The present study investigates the potential of a new therapeutic approach in lupus nephritis combining rituximab (anti-CD20) and belimumab (anti-BAFF). The main goal of the study is to assess the reduction (and seroconversion) of pathogenic autoantibodies, to evaluate clinical improvement and assess the safety and feasibility of long-term B-cell depletion.

NCT ID: NCT02284568 Completed - Clinical trials for Primary Progressive Multiple Sclerosis

A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo

ARPEGGIO
Start date: January 12, 2015
Phase: Phase 2
Study type: Interventional

This Phase 2 study is intended to serve as a proof of concept for potential treatment with laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod in this population.

NCT ID: NCT02284282 Completed - Clinical trials for Spinal Bupivacaine/Morphine in Laparoscopic Surgery

Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Salmon
Start date: August 2014
Phase: N/A
Study type: Interventional

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

NCT ID: NCT02283762 Completed - Clinical trials for Scleroderma, Systemic

Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

Start date: January 15, 2015
Phase: Phase 2
Study type: Interventional

To investigate if Riociguat is effective in the treatment of systemic sclerosis

NCT ID: NCT02283268 Completed - Clinical trials for Von Willebrand Disease

Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery

Start date: April 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von Willebrand disease (VWD).

NCT ID: NCT02282709 Completed - Chronic Hepatitis C Clinical Trials

Effect of ASV and DCV Therapy on the Quality of Immune Status in Chronic HCV Patients

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

Rationale: Chronic HCV infection is characterised by a weak HCV specific CD8+ T cell response, due to continuous pressure of high viral load. Treatment of chronic HCV patients with ASV and DCV will result in a significant drop in HCV viral load. At present, no information is available on the immunological effects of treatment with ASV and DCV, nor on the early effects of viral load reduction caused by a compound that is thought not to possess direct immunomodulatory effects. This information will be crucial for a better understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound or relapses during, at the end of treatment or during the follow up period. Objective: To evaluate in detail the functionality of immune cells in blood in chronic HCV patients before, during and after treatment with ASV and DCV, in an IFN-free regimen. Study design: This is an investigator-initiated single center open label study with one arm of 12 patients. Study population: Adult chronic HCV patients with genotype 1b, who are previous non-responders to the treatment. Intervention (if applicable): All patients will be treated with twice daily a 200 mg oASV and once daily a 60 mg DCV for 24 weeks. Main study parameters/endpoints: 1. Phenotype and function of blood leukocytes during treatment; frequency of HCV-specific T cells, NK cells and monocytes 2. Gene expression levels of leukocyte populations before, during and after treatment 3. Gene expression levels of the type I IFN signaling pathway on whole blood samples 4. Serum cytokines levels using multiplex platforms

NCT ID: NCT02282033 Completed - Bradycardia Clinical Trials

Safety and Performance Study of the Moderato System

Start date: March 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.

NCT ID: NCT02281487 Completed - Clinical trials for Abdominal Hysterectomy (& Wertheim)

Hysterectomy for Benign Gynaecological Conditions With or Without Tubectomy

HYSTUB
Start date: July 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a tubectomy during hysterectomy for benign gynaecological conditions does not result into a premature menopause.