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NCT ID: NCT03194646 Not yet recruiting - Leiomyoma Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids

Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The study is performed to assess the efficacy and safety of Vilaprisan in subjects with uterine fibroids compared to standard of care

NCT ID: NCT03194308 Not yet recruiting - HIV Prevention Clinical Trials

Safer Conception for Women

Start date: June 2017
Phase: N/A
Study type: Observational

Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.

NCT ID: NCT03187964 Not yet recruiting - HIV/AIDS Clinical Trials

Xpert Ultra and Xpert HIV-VL in People Living With HIV

Start date: July 15, 2017
Phase: N/A
Study type: Observational

TB is the biggest killer of South Africans. HIV-positive people are at higher risk of getting TB and get much sicker than HIV-negative people when they have TB. However, if TB can be quickly and correctly diagnosed, a treatment plan can be put in place to cure the disease earlier. TB is increasingly diagnosed using the GeneXpert platform, which can be used for a variety of tests (not just TB). HIV viral load monitoring is required at least annually in patients on ART to detect failure of virologic suppression, however, most HIV VL testing is done in a central lab. If a patient has virologic failure, they are more likely to get TB). We wish to see if Xpert Ultra (a new but hitherto unevaluated TB test) done at the clinic results in faster patient TB diagnosis and treatment initiation compared to sending specimens away to a central laboratory. Xpert Ultra, which is a more sensitive next generation version of the World Health Organization improved Xpert MTB/RIF test, is expected to result in the largest incremental improvement in sensitivity in patients who have paucibacillary disease (~100 CFU/ml) who are thus likely to be missed by Xpert MTB/RIF but not Xpert Ultra. In a different patient group (PLHIV returning for their HIV treatment monitoring), we wish to see if POC Xpert HIV-1 viral load (Xpert VL) monitoring results in faster patient viral load quantification compared to sending patient specimens to a centralised laboratory. Both POC tests will use the same testing hardware. This polyvalent utility of the GeneXpert system is hitherto uninvestigated in our setting. We will approach newly diagnosed HIV positive patients coming into the clinic for the first time ART and ask them to be a part of this study. If they agree, we will randomly assign patients to Ultra TB testing done at the clinic or the normal off-site laboratory TB testing. We will record how long it takes for patients to get diagnosed for TB and how long it takes for patients to start their TB drugs. We will approach a different group of HIV positive patients (on ART) returning to the clinic for annual ART follow-up visits and ask them to be a part of this study. If they agree, we will randomly select patients for Xpert VL testing done at the clinic or the normal off-site laboratory TB testing. We will record how long it takes for patients to get their viral load monitored, how long it takes for patients to get their ART regimen adjusted, or receive adherence counselling, or received HIV drug susceptibility testing, if the patient's viral loads are found to be higher than anticipated and considered by the clinical to indicate a lack of viral suppression. This project will confirm if Ultra TB testing performs well in PLHIV irrespective of symptoms, and may produce evidence that supports universal TB testing in this important and vulnerable patient group. We will also assess whether POC placement of Ultra and Xpert VL has benefits (e.g., more patients diagnosed for TB or VL monitored during the same day visit).

NCT ID: NCT03176238 Active, not recruiting - Clinical trials for Post Menopausal Breast Cancer

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Start date: March 29, 2013
Phase: Phase 3
Study type: Interventional

The present international, multi-center, open-label, single-arm study aims at collecting clinical safety, tolerability and efficacy data with the use of everolimus combined with exemestane in the Novartis Oncology Emerging Growth Market (EGM) countries for the treatment of post-menopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitor (NSAI) therapy.

NCT ID: NCT03174184 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB

Start date: September 1, 2017
Phase: Phase 2
Study type: Interventional

The overall goal of this exploratory proof-of-concept study is to determine whether, in participants with pulmonary tuberculosis caused by M. tuberculosis (MTB) with or without rifampin resistance-conferring rpoB-gene mutations, the combination of meropenem and amoxicillin/clavulanate with rifampin has greater early bactericidal activity (EBA) than the combination of meropenem and amoxicillin/clavulanate without rifampin.

NCT ID: NCT03168945 Recruiting - Tuberculosis Clinical Trials

Xpert Active Case-finding Trial 2: Community-based Active Case-finding for Tuberculosis in South Africa

Start date: November 2016
Phase: N/A
Study type: Interventional

TB kills most people with HIV in Africa. TB is out of control. Radically different approaches to deal with the disease is therefor needed. It is known that intensified case finding works in high HIV prevalence environments. However, the poor performance of conventional diagnostics makes the strategy costly and unpalatable for policy makers. If it can be shown that a package of new diagnostic technologies significantly enhances ease and speed of diagnosis, and time to treatment initiation when using intensified case finding, this will usher the way for further studies and policy adjustments to tackle TB. Thus, the work, if found to be useful, could have major policy implications The purpose of this study will be to determine the diagnostic yield, impact and feasibility of community-based intensified TB case finding using symptom screening, point-of-care TB testing (Xpert Omni), point-of-care HIV testing and CD4 count (Alere PIMA), if HIV-infected, together with a clinic-based diagnostic package (sputum smear microscopy, MGIT sputum culture, and digital chest radiograph). Additionally, the study will assess the infectiousness of previously undiagnosed TB cases in the community using cough aerosol sampling technology (CASS) and will determine the genomic, transcriptomic and lipidomic profile of TB isolates from patients undergoing CASS sampling. The cost-effectiveness of using a novel TB diagnostic platform (Xpert Omni) for intensified case finding compared to conventional methods will also be evaluated. ~6000 people will be screened to enrol 600 participants with suspected TB. It is expected that using the GeneXpert® Omni POC mobile clinic of 2- to 3-person team of healthcare workers in an inexpensive panel van will substantially reduce the time to treatment initiation, and the proportion of individuals initiating and completing TB treatment. Investigators will also review and follow up Household contacts of active TB participants. As part of the study investigators will also contribute data and specimens to the RePORT consortium (Regional Prospective Observational Research for Tuberculosis), that aims to create a multinational bank with the primary objective of providing specimens and data to RePORT consortia biomarker researchers and their collaborators over the next decade to achieve a better understanding of the prognosis of TB disease; and the pathogenesis of progression from TB exposure to disease.

NCT ID: NCT03164616 Recruiting - Clinical trials for Non Small Cell Lung Cancer NSCLC

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

Start date: June 1, 2017
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

NCT ID: NCT03162965 Recruiting - Clinical trials for Human Immunodeficiency Virus

Innovations in HIV Testing

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.

NCT ID: NCT03162107 Recruiting - Clinical trials for Patient Non-compliance

Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa

Start date: December 2016
Phase: N/A
Study type: Observational

The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.

NCT ID: NCT03158285 Not yet recruiting - Clinical trials for Arthritis, Psoriatic

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Start date: July 7, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.