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NCT ID: NCT03423979 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, feasibility study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 15 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 performance 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 Active, not recruiting - 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.

NCT ID: NCT03229421 Enrolling by invitation - Clinical trials for Zika Virus Symptoms and the Associated Exanthema

Dermatologic Manifestations of Zika Virus

Start date: July 6, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.

NCT ID: NCT03199235 Active, not recruiting - Anemia Clinical Trials

Iron Fish in Dominican Republic (DR) Children

Start date: February 20, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to assess the acceptability, feasibility, and barriers to Lucky Iron Fish™ (LIF) utilization among families with young children in a Latin American community with a high prevalence of iron deficiency and iron-deficiency anemia.

NCT ID: NCT03154125 Recruiting - Contraception Clinical Trials

Sayana® Press Extension Study

Start date: September 22, 2017
Phase: Phase 3
Study type: Interventional

This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.

NCT ID: NCT03107611 Completed - Atopic Dermatitis Clinical Trials

Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

Start date: February 29, 2016
Phase: Phase 3
Study type: Interventional

To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis. To establish superiority of each active treatment over the placebo.

NCT ID: NCT03021499 Recruiting - Lupus Nephritis Clinical Trials

Aurinia Renal Response in Active Lupus With Voclosporin

Start date: May 17, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.