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NCT ID: NCT01536873 Completed - HIV Infections Clinical Trials

Dolutegravir Expanded Access Study

DEAP
Start date: June 14, 2012
Phase: N/A
Study type: Interventional

ING114916 is an open-label, multi-center, expanded access (EAP) study

NCT ID: NCT01535391 Completed - Clinical trials for Chronic Myeloid Leukemia

Nilotinib in PH+, BCR-, ABL+ CML Patients

CML0811
Start date: January 2012
Phase: Phase 3
Study type: Interventional

This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally twice daily for 24 months and indefinitely if it is in the interest of the patient. The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice daily with dose increase to 400 mg twice daily in case of suboptimal response or failure (excluding patients who will fail for progression to ABP), in a population of patients with Ph-positive, BCR-ABL positive CML in early CP.

NCT ID: NCT01535261 Completed - Macular Edema Clinical Trials

Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

CRYSTAL
Start date: February 2012
Phase: Phase 3
Study type: Interventional

The present study will provide additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images will be analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring will be assessed in Year 2. The results of this open-label study will provide long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.

NCT ID: NCT01534962 Completed - Clinical trials for Persistent Atrial Fibrillation

Ranolazine in Atrial Fibrillation Following An ELectricaL CardiOversion

RAFFAELLO
Start date: January 2012
Phase: Phase 2
Study type: Interventional

Dose-ranging Phase II study testing the efficacy and safety of 3 doses of Ranolazine (low, intermediate and high, given BID) versus placebo in maintaining sinus rhythm after successful electrical cardioversion in patients with persistent atrial fibrillation (AFib). After successful cardioversion and subsequent randomisation, patients report trans-telephonic EGCs on a daily basis to a central core ECG facility. Maximum treatment duration is 112 days (16 weeks).

NCT ID: NCT01534754 Completed - Clinical trials for Diverticular Disease of the Colon

Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon

Start date: January 2009
Phase: Phase 4
Study type: Interventional

This is a multi-centre, randomised, double blind, double-dummy, parallel groups, placebo-controlled trial was conducted in a population of patients suffering from symptomatic uncomplicated diverticular disease in order to investigate which is the best treatment in preventing relapses of the disease. Patients were randomly divided in double-blind fashion in one of the following groups: Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month; Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 placebo, 2 tablets/day for 10 days/month; Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1 sachet/day for 10 days/month; Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month. The main objective was to assess the safety and the efficacy of mesalazine and/or Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular disease

NCT ID: NCT01533922 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients

Start date: March 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD

NCT ID: NCT01533740 Completed - Clinical trials for Metastatic Colorectal Cancer

Circulating Regulatory Lymphocytes and Outcome of Metastatic Colorectal Cancer Patients

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

Aim of the present study is to investigate whether baseline or early post-treatment (one month after treatment commencement) frequency of peripheral T regulatory lymphocytes (Tregs OR CD4+/CD25high/FOXP3+ T cells), known to suppress antitumor immune response, may influence long-term clinical outcome (i.e. radiological response, progression-free survival or overall survival) in metastatic colorectal cancer patients treated with a standard first-line chemotherapy including fluorouracil, irinotecan and bevacizumab

NCT ID: NCT01533090 Completed - Clinical trials for Inflammatory Bowel Disease

Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy

LowVolumePEG
Start date: April 2010
Phase: N/A
Study type: Interventional

The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

NCT ID: NCT01532310 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab (BENLYSTA®) Pregnancy Registry

Start date: July 16, 2012
Phase:
Study type: Observational [Patient Registry]

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

NCT ID: NCT01532284 Completed - Aneuploid Oocytes Clinical Trials

The Eshre Study Into The Evaluation of Oocyte Euploidy by Microarray Analysis

ESTEEM
Start date: February 2012
Phase: N/A
Study type: Interventional

A pragmatic, multicentre, randomized double-blind controlled trial with an intention-to-treat analysis, of the use of preimplantation genetic screening (PGS) for aneuploidy by means of microarray comparative genomic hybridization (CGH) for the chromosomal analysis of the polar bodies (PB) of oocytes collected after ovarian stimulation for in vitro fertilization (IVF), and with the intention to assess the genetic competence of oocytes of advanced biological age, and the effect of this technique on reproductive outcome.