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NCT ID: NCT01819181 Completed - Clinical trials for Symptomatic Aortic Stenosis

Women's INternational Transcatheter Aortic Valve Implantation Registry

WINTAVI
Start date: March 2013
Phase:
Study type: Observational [Patient Registry]

The study will evaluate all female patients with severe aortic stenosis undergoing transcatheter valve implantation with commercially available valves and delivery systems.

NCT ID: NCT01818856 Completed - HIV Infection Clinical Trials

Pharmacokinetic Interactions Between Telaprevir and Un-boosted Atazanavir

Start date: December 2012
Phase: Phase 1
Study type: Interventional

Hypothesis: the Telaprevir(TVR) plasma levels (750 mg q8h or 1125 mg/12h )will not be affected when co-administered with un-boosted Atazanavir (ATV) 200 mg q12h plus two analogues (NRTIs) in HCV/HIV-co-infected patients.

NCT ID: NCT01818752 Completed - Multiple Myeloma Clinical Trials

Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma

CLARION
Start date: July 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

NCT ID: NCT01818596 Completed - HIV Infections Clinical Trials

Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

Start date: March 27, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

NCT ID: NCT01818544 Completed - Bronchiectasis Clinical Trials

Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis

Start date: April 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to assess the safety and tolerability of 28 day oral administration of BAY85-8501 versus placebo in subjects with non-CF Bronchiectasis (BE). The secondary objectives are to examine the effect of BAY85-8501 on pulmonary function, biomarkers of inflammation and tissue damage, and the impact on overall health and perceived well-being and to evaluate the pharmacokinetics of BAY85-8501.

NCT ID: NCT01818492 Completed - Clinical trials for Primary Haemophagocytic Lymphohistiocytosis

Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis

Start date: July 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the current standard of care. Administration will be on top of a glucocorticosteroid, which is usually part of the current recommended treatment.

NCT ID: NCT01818115 Completed - Clinical trials for Primary Open Angle Glaucoma

Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.

Hydrus II
Start date: January 2011
Phase: N/A
Study type: Interventional

The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

NCT ID: NCT01817218 Completed - Chronic Ulcer Clinical Trials

Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers

PRP-2012
Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all the assistance levels, and they have big repercussion referring to individual, social and labour levels, supposing a big consumption of human and material resources.The cure with autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the cicatrization time comparing to conventional methods in hospital levels, which becomes interesting contrasting its efficacy in primary care. AIM:Evaluate the practicability, security and potential of the autologous PRP in the treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP classification). DESIGN:A pilot study will be executed, which will consist in a randomized clinical test, multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers will be studied, who will be between the age of 40-80 years old, and who will be attached to five health centers. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area decreasing", "CIVIQ index", "% one cure per week" .

NCT ID: NCT01816724 Completed - Nocturia Clinical Trials

Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia

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

The objective of this study is to validate the spanish (from Spain) version of the "Nocturia Quality of Life Questionnaire and assess their psychometric properties, using the spanish translation provided by the copyright holder. Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by Intraclass Correlation Coefficient), Convergent Validity (assessed using other already validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be evaluated.

NCT ID: NCT01816594 Completed - Clinical trials for HER2-positive Newly Diagnosed, Primary Breast Cancer

NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer

NeoPHOEBE
Start date: September 3, 2013
Phase: Phase 2
Study type: Interventional

This randomized, parallel cohort, two stage, double-blind, placebo-controlled study evaluated the oral PI3K inhibitor BKM120 in combination with trastuzumab and paclitaxel in HER2-positive, PIK3CA wild-type and PIK3CA mutant primary breast cancer prior to surgery (neo-adjuvant setting).