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NCT ID: NCT03700658 Recruiting - Contraception Clinical Trials

A Study to Evaluate Injection Pain and Local Tolerability Following Subcutaneous Administration of TV46046

Start date: January 15, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the local tolerability associated with the subcutaneous administration of TV-46046, and inform next steps of the TV-46046 development program.

NCT ID: NCT03616106 Active, not recruiting - Clinical trials for Health Communication

Information Visualizations to Facilitate HIV-related Patient-provider Communication (Info Viz: HIV)

Start date: October 9, 2018
Phase: N/A
Study type: Interventional

To complete the study aims, a mixed methods study that includes a single group pretest-posttest study design will be used to pilot test the infographic intervention. In-depth interviews will be completed with a selection of participants to explore participant perceptions of HIV-related communication using infographics. Data will be collected from participants through baseline (at enrollment) and follow up assessments (at 3-, 6-, and 9-month follow up visits). Follow up interviews will be conducted with the providers involved in the intervention to ascertain their perspectives on the clinical utility of infographics.

NCT ID: NCT03606993 Recruiting - Clinical trials for Iron Deficiency Anemia

Iron Fish for Dominican Republic (DR) Infants

Start date: August 13, 2018
Phase: N/A
Study type: Interventional

This study evaluates the feasibility of cooking with an iron ingot, Lucky Iron Fish™ (LIF), and evaluate the natural history of hemoglobins and iron status among infants of families using this iron ingot in a population with a high prevalence of iron-deficiency anemia. Participants are mother-infant dyads, and are randomized to one of two arms: Lucky Iron Fish™or enhanced standard of care.

NCT ID: NCT03568682 Recruiting - HIV Clinical Trials

Improving Antiretroviral Therapy Adherence Through Urban Gardening and Nutritional Counseling in the Dominican Republic

Start date: May 22, 2018
Phase: N/A
Study type: Interventional

This pilot study proposes to develop, implement, and evaluate the feasibility, acceptability and preliminary effectiveness of a culturally appropriate, multi-component intervention combining peer nutrition counseling with sustainable urban gardening among people with HIV in the Dominican Republic. The overall hypothesis is that this combined intervention will improve adherence to antiretroviral therapy (ART) and virologic suppression among food insecure HIV+ individuals with suboptimal adherence.

NCT ID: NCT03547908 Recruiting - Clinical trials for HIV-1/HBV Co-Infection

Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

Start date: May 30, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.

NCT ID: NCT03423979 Active, not recruiting - Clinical trials for Benign Prostatic Hyperplasia

Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Start date: December 19, 2017
Phase: Phase 2
Study type: Interventional

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

NCT ID: NCT03337906 Completed - HIV Infections Clinical Trials

An Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

Start date: July 11, 2008
Phase: N/A
Study type: Observational

An observational study of long-term outcomes of HIV-1 infection in persons who become infected after enrollment in HIV-1 vaccine trials

NCT ID: NCT03279120 Recruiting - Contraceptive Usage Clinical Trials

Safety, PK, and PD Study of IVRs Releasing TFV and LNG

Start date: September 28, 2017
Phase: Phase 1
Study type: Interventional

This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, during and after 90 days of continuous or interrupted IVR use.

NCT ID: NCT03239496 Completed - Poliomyelitis Clinical Trials

A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV

Start date: October 23, 2017
Phase: Phase 3
Study type: Interventional

The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.

NCT ID: NCT03230539 Recruiting - Contraception Clinical Trials

A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA)

Start date: May 1, 2017
Phase: Phase 1
Study type: Interventional

The UPA doses to be tested in this new IUS, 5, 20 or 40 μg per day, are not expected to suppress ovulation, however they should prevent endometrial growth resulting in endometrial atrophy, minimal bleeding, or even amenorrhea. It is anticipated that with low UPA doses, women will continue to ovulate and secrete progesterone (P) during the secretory phase of the menstrual cycle. As a result, PRM associated endometrial changes (PAECs) that have been described in previous UPA studies when ovulation was suppressed and associated with amenorrhea should not occur and endometria should retain normalcy. These expectations are based on our findings from a previous study in which the UPA doses tested were insufficient to block ovulation and participants maintained P secretion with normal endometria (protocol 349). Further evidence regarding the benefit of using low doses of UPA in a copper IUS stems from a small rhesus macaque proof of principle study that included an UPA-IUS delivering 40 or 60 μg/d of UPA, and fixed doses of E2 and cyclic P delivered via implants over 3 cycles.24 Indices of endometrial proliferation were significantly reduced in 3 out of 5 animals in that study; the endometria were atrophied with some glandular cysts, and typical PAECs were limited. Glands were generally small and tubular, however, in some animals they were large and dilated; resembling cysts with minimal evidence of proliferative activity.24 No bleeding was observed in the treated monkeys during progesterone withdrawal over the 3 cycles.