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NCT ID: NCT03052517 Terminated - Asthma Clinical Trials

Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

Start date: March 21, 2017
Phase: Phase 3
Study type: Interventional

This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma. The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients: 1. Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and 2. New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039. By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

NCT ID: NCT02868827 Terminated - Critical Illness Clinical Trials

Cholecalciferol Supplementation in Critically Ill Patients With Severe Vitamin D Deficiency.

Start date: August 27, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the research study is to determine whether a single high dose of vitamin D is helpful in reducing critical illness related complications in intensive care patients who are having sever vitamin D deficiency. Vitamin D deficiency is quite common in critically ill patients ranging from 81.5% to 99%. A number of scientific studies have documented a strong correlation between low levels of vit.D and increased rate of adverse outcomes including infection, acute kidney injury and mortality in ICU patients. A recent randomized controlled trial (RCT) has demonstrated a 50% reduction in hospital mortality in severe vit.D deficient patients following a single high dose of cholecalciferol (Vitamin D3). However, the role of Vit.D supplementation to boost up host immune system and eventually reduction of mortality has yet to be determined by large randomized controlled trials in humans. Hence the study aims to run a randomized controlled trial (RCT) in order to study the role of Vitamin D in critically ill patients.

NCT ID: NCT02616328 Terminated - Clinical trials for Rheumatoid Arthritis

A Study of the Efficacy and Safety of Tocilizumab for Confirmed Rheumatoid Arthritis (RA) Participants in Clinical Practice

Start date: January 26, 2017
Phase:
Study type: Observational

This is a single-arm, open-label, non-randomized, multicenter trial to evaluate the efficacy and safety of using tocilizumab for confirmed rheumatoid arthritis participants in clinical practice.

NCT ID: NCT02611310 Terminated - Clinical trials for Metastatic Breast Cancer

A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)

Start date: January 19, 2017
Phase:
Study type: Observational

This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment. These participants will be prospectively followed for at least 5 years after study enrollment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.

NCT ID: NCT02595814 Terminated - Acute Heart Failure Clinical Trials

Global Non-interventional Heart Failure Disease Registry

REPORT-HF
Start date: July 23, 2014
Phase:
Study type: Observational [Patient Registry]

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.

NCT ID: NCT02443545 Terminated - Sickle Cell Disease Clinical Trials

Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias

Start date: May 21, 2015
Phase: Phase 4
Study type: Interventional

This is a long-term follow-up to an earlier study, LA38-0411. Its purpose is to gather more information about the safety and efficacy of deferiprone in patients with sickle cell disease or other anemias who suffer from iron overload caused by regular blood transfusions.

NCT ID: NCT02273856 Terminated - Clinical trials for Chronic Lymphocytic Leukaemia (CLL)

Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL)

NADIR
Start date: January 2015
Phase: N/A
Study type: Observational

The purpose of this study is to document the pharmacological treatment strategies used in treatment naïve and previously treated relapsed/refractory iNHL/CLL patients in the Middle East and North African (MENA) region. This study will also record encountered tumor subtype and stage and the instituted pharmacological treatments, as well as assess the clinical outcomes of treatments.

NCT ID: NCT02176122 Terminated - Clinical trials for Bloodstream Infections

RCT Meropenem vs Piperacillin-Tazobactam for Definitive Treatment of BSI's Due to Ceftriaxone Non-susceptible Escherichia Coli and Klebsiella Spp.

MERINO
Start date: February 2014
Phase: Phase 4
Study type: Interventional

No randomized controlled trials (RCTs) have yet been performed comparing different treatment options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen an exponentially increasing rate of carbapenem resistance worldwide, including Australia and New Zealand. The investigators urgently need data from well-designed RCTs to guide clinicians in the treatment of antibiotic resistant Gram-negative infections. The investigators face a situation where a commonly used antibiotic for these infections (meropenem) may be driving carbapenem resistance. For this reason, the investigators are seeking to compare a carbapenem-sparing regimen with a carbapenem for the treatment of these infections. Formal evaluation of safety and efficacy of generic antibiotics in the treatment of infection is of immense clinical and public health importance, and no formal trial has yet been conducted to address these issues. The international collaboration between teams of clinician researchers, some of whom are leaders in their field, makes it highly likely that the outcomes of this trial will have a significant impact on clinical practice. The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen) is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or Klebsiella species.

NCT ID: NCT02138825 Terminated - Clinical trials for Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary

Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)

RISE-IIP
Start date: June 4, 2014
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).

NCT ID: NCT02086487 Terminated - Clinical trials for Myeloid Leukemia, Chronic

Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy

NISRI
Start date: March 2013
Phase: Phase 4
Study type: Interventional

whether Nilotinib at the two sequential dosage forms will induce quicker and deeper response in those patients, and if FISH on PB (Peripheral blood) would be an effective way to monitor response compared to conventional cytogenetics on bone marrow (BM) sample