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NCT ID: NCT02859909 Completed - Clinical trials for Immune Thrombocytopenia

This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)

Start date: November 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in addition to further efficacy assessments, are to evaluate the safety of BT595.

NCT ID: NCT02853604 Terminated - Clinical trials for Advanced Cervical Cancer

Study of ADXS11-001 in Participants With High Risk Locally Advanced Cervical Cancer

AIM2CERV
Start date: December 15, 2015
Phase: Phase 3
Study type: Interventional

Locally advanced cervical cancer at higher risk for recurrence (HRLACC) following concurrent chemotherapy and radiation therapy. This is a group of participants with a significant unmet need. The estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and the prognosis is very grave for those who experience a recurrence. The purpose of the study was to compare the disease free survival (DFS) of ADXS11-001 to placebo administered following cisplatin-based combination chemotherapy and radiation (CCRT) with curative intent in participants with HRLACC.

NCT ID: NCT02851797 Completed - Clinical trials for Duchenne Muscular Dystrophy

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

Start date: June 6, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective The primary objective of the study was to establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects. Secondary Objectives The secondary objectives of this study were: - To assess the safety and tolerability of givinostat versus placebo administered chronically in DMD subjects - To evaluate the PK profile of givinostat administered chronically in DMD subjects - To evaluate the impact on quality of life (QoL) and activities of daily living of givinostat versus placebo administered chronically.

NCT ID: NCT02847598 Completed - Clinical trials for Systemic Lupus Erythematosus

Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

LILAC
Start date: October 20, 2016
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).

NCT ID: NCT02834884 Recruiting - All Tumor Types Clinical Trials

SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access

SPECTA
Start date: May 3, 2017
Phase:
Study type: Observational [Patient Registry]

SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.

NCT ID: NCT02833350 Completed - Clinical trials for Rheumatoid Arthritis

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

Start date: September 9, 2016
Phase: Phase 2
Study type: Interventional

This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of GDC-0853 in participants with moderate to severe active RA and an inadequate response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic (Cohort 2).

NCT ID: NCT02832219 Completed - Obesity Clinical Trials

Medium-term Effects of Molecular Hydrogen on Metabolic Fitness in Obesity

Start date: January 2016
Phase: Phase 3
Study type: Interventional

Molecular hydrogen (H2) effectively tackles obesity-related disorders in animal models yet no studies so far investigated the effectiveness of H2 for improving biomarkers of obesity in humans. In this double blind, placebo-controlled, crossover pilot trial, the investigators will evaluate the effects of H2 intervention on body composition, hormonal status, and mitochondrial function in middle age overweight women, with hydrogen administered orally for 4 weeks.

NCT ID: NCT02831959 Active, not recruiting - Clinical trials for Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC).

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-200M and supportive treatment compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT02831244 Completed - Clinical trials for Osteoarthritis of Multiple Joints of Ankle or Foot

Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe

Start date: August 10, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.

NCT ID: NCT02830854 Completed - Aging Clinical Trials

Molecular Hydrogen for Cognitive Function and Performance in Elderly

Start date: July 2016
Phase: Phase 3
Study type: Interventional

A variety of non-pharmacological interventions have been used in the management of Alzheimer's disease (AD) and similar cognitive disorders in elderly, yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. Although it is still unknown what triggers AD, recent studies have shown that AD is associated with brain energy depletion, oxidative stress, and mitochondrial dysfunction. Since supplemental molecular hydrogen (H2) supports cell energy production and acts as a highly bioavailable mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and perhaps prevention of AD and similar cognitive disorders in elderly. The overall hypothesis to be evaluated in this project is that administration of H2 will positively affect patient-reported outcomes and clinical biomarkers in men and women suffering from AD.