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NCT ID: NCT02435433 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein

REACH-2
Start date: July 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrollment [MEE] Cohort). Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.

NCT ID: NCT02432703 Completed - Phobic Disorders Clinical Trials

A Safety and Efficacy Study of JNJ-42165279 in Participants With Social Anxiety Disorder

Start date: June 11, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of treatment in participants with Social Anxiety Disorder (SAD).

NCT ID: NCT02432547 Completed - Clinical trials for Diabetic Retinopathy

Laser Therapy Combined With Intravitreal Aflibercept vs Intravitreal Aflibercept Monotherapy (LADAMO)

LADAMO
Start date: June 15, 2017
Phase: Phase 4
Study type: Interventional

This will be a 24 month phase IV, randomised, prospective, multicentre, clinical trial of laser therapy to areas of peripheral retinal ischaemia combined with intravitreal aflibercept versus intravitreal aflibercept monotherapy. Both arms will have 2mg intravitreal aflibercept according to a treat and extend protocol. The specific aim of the study is to test whether laser therapy of peripheral retinal ischaemia reduces the overall number of intravitreal aflibercept injections required to control DMO over a 24 month period.

NCT ID: NCT02431858 Completed - Nerve Block Clinical Trials

Catheter Over Needle vs Catheter Through Needle

Start date: May 2015
Phase: Phase 4
Study type: Interventional

To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.

NCT ID: NCT02431650 Completed - Malaria Clinical Trials

Effectiveness of OZ439 as a Gametocytocidal and Transmission Blocking Agent

OZGAM
Start date: April 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-centre, controlled, open label study using P. falciparum-induced blood stage malaria (IBSM) infection to assess the effectiveness of OZ439 as a gametocytocidal agent, as well as its treatment effects on gametocyte infectivity and development in vector mosquitoes. Previous clinical studies including one IBSM study have shown that in addition to effectively clearing replicating, asexual (pathogenic) life cycle stages of malaria, a single dose of piperaquine (480 mg) results in the production of gametocytes, as determined by gametocyte-specific transcript (pfs25) qPCR. The propensity of piperaquine to induce gametocytaemia will be employed in this study to assess the efficacy of OZ439 as a gametocytocidal and transmission blocking agent. Experimental mosquito feeding via both direct feeding on participants and artificial (indirect) membrane mosquito feeding will be performed. The study will be conducted in up to 3 cohorts where participants will be randomised into an experimental or a control group (n=2 per group) when peak gametocytemia occurs (approximately 15 days after administration of piperaquine).

NCT ID: NCT02431637 Completed - Malaria Clinical Trials

Experimental Falciparum Transmission to Anopheles

EFITA
Start date: April 2015
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label study using P. falciparum-induced blood stage malaria (IBSM) infection to assess the infectivity of sexual life cycle stages of the malaria parasite (gametocytes) to mosquito vectors. Previous clinical studies have shown that treatment of participants with the antimalarial drug piperaquine, in addition to effectively clearing asexual (pathogenic) stages of the malaria life cycle, induces the production of gametocytes in the blood. The propensity of piperaquine to induce gametocytemia will be employed in this study to assess gametocyte infectivity to Anopheles mosquitoes. For this purpose, experimental mosquito feeding directly on participants and artificial membrane mosquito feeding will be performed. The study will be conducted in 3 cohorts (n=2 per cohort). Subsequent cohorts will not commence until at least after day 28 of the previous cohort and review by Safety Review Team. This interval will also allow cohorting of experimental infection of mosquitoes to optimise logistics and enable iterative improvements in the system if applicable.

NCT ID: NCT02431312 Completed - Hepatitis B Clinical Trials

Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects

Start date: January 12, 2015
Phase: Phase 1
Study type: Interventional

This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and Hepatitis B core antigen [HBcAg]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.

NCT ID: NCT02429791 Completed - HIV Infections Clinical Trials

Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)

Start date: April 14, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

NCT ID: NCT02426125 Completed - Clinical trials for Urothelial Carcinoma

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer

RANGE
Start date: July 13, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.

NCT ID: NCT02425891 Completed - Clinical trials for Triple Negative Breast Cancer

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

Start date: June 23, 2015
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.