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NCT ID: NCT01918397 Completed - Clinical trials for Tuberculosis, Multidrug-Resistant

Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB

Opti-Q
Start date: January 2015
Phase: Phase 2
Study type: Interventional

Multi-drug-resistant tuberculosis (MDR-TB) affects nearly 600,000 persons each year around the world. This type of tuberculosis is very difficult to treat, and many patients die from it. Drugs of the fluoroquinolone class are very important for treating MDR-TB, but the best dose of one of the most effective fluoroquinolones, levofloxacin, is not known. This application proposes a study to determine the best dose of levofloxacin to use in treating MDR-TB. 120 patients will receive their usual treatment, plus levofloxacin at one of four doses. The study will be performed in Peru and in South Africa, where MDR-TB is common.

NCT ID: NCT01903733 Completed - Clinical trials for Chronic Myeloid Leukemia

Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

Start date: August 28, 2013
Phase: N/A
Study type: Interventional

The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.

NCT ID: NCT01903031 Completed - HIV-1 Infection Clinical Trials

Evaluating Pharmacokinetic Interactions With Vaginal Ring Contraceptives and ART

Start date: December 30, 2014
Phase: Phase 2
Study type: Interventional

This study was done to look at a method of hormonal birth control, called the NuvaRing, and specific anti-HIV medications, called antiretrovirals (ARVs). Some studies of women who use a hormonal birth control method (specifically oral pills, patches, and injections) and take ARVs have shown that ARVs interact with the hormones released by the birth control medication. These interactions may cause the birth control to be less effective at preventing pregnancy. There is also concern that hormonal birth control can increase HIV spreading to others, but more studies are needed to determine if this is true. The investigators did not know whether the NuvaRing and ARVs interact when they are used together, so this study looked to see if certain ARVs (efavirenz and atazanavir/ritonavir) interact with the two hormones released by NuvaRing. This will help us to determine if NuvaRing is safe and effective for women with HIV infection who are taking ARVs. The study also included HIV-infected women who were not on ARVs but used the NuvaRing to show us what the hormone levels are like in a similar group of women not on ARVs. Vaginal rings are also currently being studied to deliver anti-HIV medications that may prevent HIV acquisition, and to provide birth control over a longer period of time (more than 1 month). Since vaginal rings will become more commonly used to administer medications, the investigators wanted to better understand the potential for drug interactions with drugs given vaginally. This study will also help us understand the potential for drug interactions between ARVs given orally, and other drugs given through vaginal rings, like the NuvaRing. Additionally, this study will help us understand how hormones released from a vaginal ring affect the amount of HIV virus in the genital tract, the bacterial make-up (microbiome) of the female genital tract, and the immune system within the genital tract, all of which may affect the chances of spreading HIV.

NCT ID: NCT01890473 Completed - Clinical trials for Rheumatoid Arthritis

Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

Start date: July 2013
Phase: Phase 1
Study type: Interventional

The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

NCT ID: NCT01887912 Terminated - Clinical trials for Clostridium Difficile Infection

Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Start date: July 30, 2013
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: - To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: - To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. - To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: - To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: - To describe the safety profile of all participants who received at least 1 injection.

NCT ID: NCT01887600 Completed - Clinical trials for Anemia in Chronic Kidney Disease in Non-dialysis Patients

Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis

ALPS
Start date: September 3, 2013
Phase: Phase 3
Study type: Interventional

This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study was to see if Roxadustat is both effective and safe as a treatment for anemia in patients with chronic kidney disease.

NCT ID: NCT01881659 Active, not recruiting - Cervical Cancer Clinical Trials

Cervical Cancer Screening With Human Papillomavirus Testing

ESTAMPA
Start date: May 2013
Phase:
Study type: Observational

HPV testing for primary cervical cancer screening of women over 30 years of age is likely to become the standard of care in the near future in many areas of the world. Its high sensitivity can significantly improve the effectiveness of screening programs and its prolonged negative predictive value can allow extension of screening intervals. However, a single HPV test has low positive predictive value and can lead to unnecessary workup and over-treatment and generate unnecessary distress. This multi-centric study will screen 50,000 women with HPV testing and compare several triage approaches that can follow HPV testing in order to make an HPV-based screening programme efficient, affordable and sustainable.

NCT ID: NCT01875393 Completed - Prostate Cancer Clinical Trials

Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

PCM304
Start date: May 2013
Phase: Phase 3
Study type: Interventional

The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.

NCT ID: NCT01875003 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Start date: August 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.

NCT ID: NCT01872689 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: October 13, 2013
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.