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NCT ID: NCT02340182 Completed - Healthy Clinical Trials

The Role of the Microbiota in the Systemic Immune Response

MISSION-1
Start date: March 2013
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the role of the gut microbiota in the systemic priming of immune effector cells. Twelve healthy male volunteers, 18-35 years of age, will be treated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days, in order to deplete the gut microbiota. Blood and faeces will be sampled before, 24 hours and 6 weeks after the 7-day period of antibiotics. Main study endpoints include laboratory parameters for inflammatory responses, functional assays (ex vivo stimulation assay) and gut microbiota composition.

NCT ID: NCT02339779 Active, not recruiting - Breast Cancer Clinical Trials

Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy

BREAST
Start date: October 2015
Phase: N/A
Study type: Interventional

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.

NCT ID: NCT02339610 Completed - Clinical trials for Non-inflammatory Degenerative Joint Disease

Evaluation of Post-Operative Recovery in ATTUNE® Total Knee Arthroplasty

Start date: January 1, 2015
Phase:
Study type: Observational

This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).

NCT ID: NCT02339402 Recruiting - Hereditary Disease Clinical Trials

Non Invasive Prenatal Testing (NIPT) of Single-gene Disorders

Start date: June 2014
Phase: N/A
Study type: Observational

Developing a new non-invasive prenatal test for single gene disorders from cell free fetal DNA, retrieved from the mothers blood.

NCT ID: NCT02338154 Completed - Aortic Stenosis Clinical Trials

EDWARDS INTUITY Valve System FOUNDATION Study

FOUNDATION
Start date: July 2012
Phase:
Study type: Observational

The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population. The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

NCT ID: NCT02337907 Completed - Alzheimer Disease Clinical Trials

BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Start date: January 21, 2015
Phase: Phase 2
Study type: Interventional

The study is designed to compare the effects of BI 409306 compared to placebo in patients with cognitive impairment due to Alzheimer's Disease

NCT ID: NCT02337699 Terminated - Clinical trials for Post Surgical Groin Pain

Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain

GASPA
Start date: January 2015
Phase:
Study type: Observational

25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.

NCT ID: NCT02337244 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Zimmer POLAR Persona - TKA (EMEA Study)

Start date: November 18, 2013
Phase:
Study type: Observational

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona knee implants used in primary total knee arthroplasty. The assessment will include: 1. Implant survivorship based on removal of a study device. 2. Safety based on incidence and frequency of adverse events. 3. Clinical performance measured by overall pain and function, quality of life data, radiographic parameters and survivorship.

NCT ID: NCT02336451 Completed - Clinical trials for ALK-positive Non-small Cell Lung Cancer

A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

Ascend-7
Start date: April 1, 2015
Phase: Phase 2
Study type: Interventional

This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.

NCT ID: NCT02336425 Terminated - Asthma Clinical Trials

Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

Start date: September 2015
Phase: Phase 2
Study type: Interventional

This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).