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NCT ID: NCT03191799 Not yet recruiting - Hemophilia A Clinical Trials

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

STASEY
Start date: July 27, 2017
Phase: Phase 3
Study type: Interventional

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

NCT ID: NCT03114657 Recruiting - Alzheimer's Disease Clinical Trials

A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

CREAD 2
Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

NCT ID: NCT03049527 Completed - Clinical trials for Chronic Kidney Disease

CKDu in Sugarcane Workers in Guatemala

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The objective of this research project is to investigate specific behaviors and exposures related to sugarcane work and their association with non-communicable diseases, specifically Chronic Kidney Disease of Unknown Origin (CKDu) among sugarcane workers in Guatemala. Over the course of the 6-month sugarcane harvest the investigators will assess risk factors for declining kidney function, and also changes in biomarkers of kidney function pre and post work shift of field and factory workers and their possible relationships with dehydration and heat stress. The investigators will also evaluate the effectiveness of an intervention aimed at increasing hydration and reducing heat stress. Finally the investigators will measure biomarkers of exposure and environmental samples for heavy metals, agrochemicals, and infectious disease (Leptospira).

NCT ID: NCT03037970 Recruiting - Clinical trials for Diabetic Foot Ulcers

Evaluation of ABSOLVE in Diabetic Foot Ulcers

ABSOLVE
Start date: January 30, 2017
Phase: Phase 2
Study type: Interventional

ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).

NCT ID: NCT03027297 Active, not recruiting - HIV-1 Infections Clinical Trials

TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to continue the provision of darunavir/ low-dose ritonavir (DRV/rtv) to adult and pediatric patients who previously received DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial TMC114-TiDP29-C232 who continue to benefit from the use of DRV/rtv, in countries where DRV is not commercially available for the subject, is not reimbursed, or cannot be accessed through another source (e.g., access program, governmental program).

NCT ID: NCT03001219 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

Start date: December 22, 2016
Phase: Phase 2
Study type: Interventional

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.

NCT ID: NCT02944682 Not yet recruiting - Clinical trials for Infant, Low Birth Weight

Household Air Pollution and Health: A Multi-country LPG Intervention Trial

Start date: September 2017
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial of liquefied petroleum gas (LPG) stove and fuel distribution in 3,200 households in four countries (India, Guatemala, Peru, and Rwanda). Following a common protocol, each intervention site will recruit 800 pregnant women (aged 18-34 years, <20 weeks gestation), and will randomly assign half their households to receive LPG stoves and a 30-month supply of LPG. Controls will receive the same cookstoves and LPG supply at the end of the study. The mother will be followed along with her child until the child is 2 years old. The researchers estimate that 25% of households will have a second, non-pregnant older adult woman (aged 35-64 years) who will also be enrolled at baseline and followed during the 30-month follow-up period. To optimize intervention use, the researchers will implement behavior change strategies informed by previous experiences and formative research in Year 1. This study will assess cookstove use, conduct repeated personal exposure assessments of household air pollution, and collect dried blood spots and urinary samples for biomarker analysis and biospecimen storage. The primary outcomes are low birthweight, pneumonia incidence, and linear growth in the child, and blood pressure in the older adult woman. Secondary outcomes include preterm birth and gross motor development in the child, maternal blood pressure during pregnancy, and endothelial function, respiratory impairment, carcinogenic metabolites, and quality of life in the older adult woman.

NCT ID: NCT02856984 Recruiting - Clinical trials for Zika Virus Disease (Disorder)

Zika in Infants and Pregnancy (ZIP)

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

The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of pregnant women during the first trimester of pregnancy and follow them through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.

NCT ID: NCT02826603 Recruiting - Plaque Psoriasis Clinical Trials

Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

CLARITY
Start date: June 2016
Phase: Phase 3
Study type: Interventional

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

NCT ID: NCT02812914 Recruiting - Premature Birth Clinical Trials

NACER II: Reducing Prenatal Exposures to Household Air Pollution in Rural Guatemala Through a Gas Stove/Behavior Intervention to Improve Neonatal Health

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

Greater efforts are needed to bring affordable, clean stoves and adaptive behavioral strategies to the millions of households worldwide that continue to burn solid cooking fuels using inefficient stoves. Two of the leading causes of infant mortality, preterm birth and pneumonia, are associated with high exposures to household air pollution during pregnancy and early infancy. The proposed study will assess the feasibility and acceptability of an introduced liquid petroleum gas stove, complemented by two alternative approaches to delivering tailored behavioral change interventions, among pregnant women and their neonates.