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NCT ID: NCT03655002 Active, not recruiting - Clinical trials for Recurrent Hepatocellular Carcinoma

IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer

Start date: February 21, 2019
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of IRX-2 when given together with cyclophosphamide and nivolumab in treating patients with liver cancer that has come back or spread to other parts of the body and does not response to treatment. Biological therapies, such as IRX-2, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving IRX-2, cyclophosphamide, and nivolumab may work better than the IRX?2 regimen alone in treating patients with hepatocellular carcinoma.

NCT ID: NCT03654807 Active, not recruiting - Frailty Clinical Trials

The Effect of Walking on Frailty

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effect of walking intensity on both frailty category (i.e., frail, pre-frail, and nonfrail) and frailty score as a continuous outcome on the SHARE-FI (frailty instrument). As well as test the effect of walking intensity on mobility, physical function, balance, and total Physical Activity.

NCT ID: NCT03654768 Active, not recruiting - Clinical trials for Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia

Start date: October 24, 2018
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well ruxolitinib phosphate, and bosutnib, dasatinib, imatinib or nilotinib, work in treating patients with chronic myeloid leukemia. Chronic myeloid leukemia cells produce a protein called BCR-ABL. The BCR-ABL protein helps chronic myeloid leukemia cells to grow and divide. Tyrosine kinase inhibitors, such as bosutinib, dasatinib, and nilotinib, stop the BCR-ABL protein from working, which helps to reduce the amount of chronic myeloid leukemia cells in the body. Ruxolitinib is a different type of drug that helps to stop the body from making substances called growth factors. Chronic myeloid leukemia cells need growth factors to grow and divide. The addition of ruxolitinib to the tyrosine kinase inhibitor may or may not help reduce the amount of chronic myeloid leukemia cells in the body.

NCT ID: NCT03654690 Active, not recruiting - HIV Infections Clinical Trials

eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men

eTest
Start date: January 23, 2019
Phase: N/A
Study type: Interventional

The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented "hook-up" mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral ("eTEST" condition), (2) "standard" HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic ("control" condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.

NCT ID: NCT03654638 Active, not recruiting - Clinical trials for Prostate Adenocarcinoma

Soy Bread Diet in Improving Immune Function in Participants With Prostate Cancer

Start date: August 15, 2018
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effects of a soy bread versus a wheat bread in improving immune function in participants who are beginning a course of androgen deprivation therapy for prostate cancer. Components found in soy foods may influence the immune system in a way that may be beneficial for prostate cancer prevention and survivorship.

NCT ID: NCT03654547 Active, not recruiting - Clinical trials for Advanced Solid Tumors

Safety of TT-00420 (Tinengotinib) Monotherapy in Patients With Advanced Solid Tumors and Triple Negative Breast Cancer

Start date: January 8, 2019
Phase: Phase 1
Study type: Interventional

This is a first-in-human, phase I clinical research study with TT-00420, an investigational, oral, multi-target, dual mechanism kinase inhibitor targeting both mitosis and tumor micro-environment, for the treatment of triple negative breast cancer (TNBC) and other advanced solid tumors. The study consists of a dose escalation part followed by a MTD expansion part.

NCT ID: NCT03654053 Active, not recruiting - Cirrhosis Clinical Trials

Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis

SACRED
Start date: October 2, 2020
Phase: Phase 3
Study type: Interventional

This phase III, randomized, double-blind, placebo-controlled, multi-center study seeks to test whether simvastatin, a statin usually used to lower cholesterol to prevent heart problems and strokes, can lower the risk of hepatic decompensation (developing symptoms of cirrhosis) in U.S. Veterans who have compensated cirrhosis (the liver is scarred and damaged but there are no symptoms). The study will also explore how changes or differences in genes effect the safety and effectiveness of using statins and how the use of statins affects quality of life.

NCT ID: NCT03653663 Active, not recruiting - Clinical trials for Statin Adverse Reaction

NIRS to Diagnose SAMS

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

This proposal seeks to determine whether near infrared spectroscopy (NIRS) can differentiate between patients with confirmed SAMS and those with non-specific muscle complaints. NIRS is a non-invasive technique of assessing skeletal muscle tissue oxygenation and mitochondrial function. Mitochondrial dysfunction is a possible cause of SAMS, but NIRS has never been evaluated as a diagnostic tool for SAMS. Investigators will enroll 40 patients with a history of SAMS in an 8 wk randomized, double-blind crossover trial of simvastatin 20 mg/d and placebo separated by a 4 wk washout phase. Tissue oxygenation will be measured using NIRS during a short handgrip exercise protocol before and after each treatment period. Investigators will query patients about muscle complaints weekly during both phases of the study with a validated survey to assess muscle pain. Investigators will classify patients as testing positive for SAMS if they report pain on simvastatin and not placebo. Investigators hypothesize that these patients, vs. patients experiencing pain on both treatments, placebo, or neither treatment, will be distinguished by reduced tissue oxygenation during simvastatin treatment relative to placebo, demonstrating efficacy of NIRS as a clinical tool that can be eventually used for the diagnosis and ultimately treatment of SAMS.

NCT ID: NCT03653507 Active, not recruiting - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

GLOW
Start date: November 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.

NCT ID: NCT03653247 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease

Start date: March 6, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, multicenter, Phase 1/2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003.