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NCT ID: NCT04596540 Completed - Chronic Gout Clinical Trials

A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II

DISSOLVE II
Start date: November 30, 2020
Phase: Phase 3
Study type: Interventional

This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy were performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.

NCT ID: NCT04596475 Completed - Hepatitis C Clinical Trials

Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

Start date: May 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).

NCT ID: NCT04596319 Completed - Cystic Fibrosis Clinical Trials

Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis

SWARM-Pa
Start date: December 22, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection.

NCT ID: NCT04596293 Completed - Ulcerative Colitis Clinical Trials

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis

Start date: June 11, 2021
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.

NCT ID: NCT04596254 Completed - Healthy Diet Clinical Trials

Detection of Gut Metabolites in Mother's Milk Following Juice Intake

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.

NCT ID: NCT04596241 Completed - Fat Disorder Clinical Trials

Non-invasive Lipolysis and Improvement of Muscle Tone in Upper Arms

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of arms. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.

NCT ID: NCT04596228 Completed - Fat Disorder Clinical Trials

Non-invasive Lipolysis and Improvement of Muscle Tone in Inner Thighs

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the clinical efficacy and safety of the BTL-899 device for changes in subcutaneous fat tissue and muscle tissue of inner thighs. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device

NCT ID: NCT04596150 Completed - Breast Cancer Clinical Trials

Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer

Start date: December 29, 2020
Phase: Phase 2
Study type: Interventional

A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

NCT ID: NCT04596111 Completed - Water Sports Clinical Trials

Physiological Variables and Rowing Performance.

Start date: October 21, 2020
Phase:
Study type: Observational

The purpose of this study is to investigate the association between the changes in physiological variables based on fitness testing and the changes in rowing performance.

NCT ID: NCT04595838 Completed - Oral Mucositis Clinical Trials

A Trial Assessing Chemo Mouthpiece Device With Best Supportive Care for Symptoms of Chemotherapy-Induced Oral Mucositis

Start date: August 31, 2020
Phase: N/A
Study type: Interventional

This study will compare the use of the Chemo MouthpieceTM device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of Chemo MouthpieceTM in lessening symptoms associated with chemotherapy regimen known to place patients at risk for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom management. Subjects who are receiving standard chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. All subjects will complete daily diaries for the first 14 days of chemotherapy Cycles 1 and 2. Subjects who are assigned to the study device arm will use the device during their chemotherapy infusion in clinic and will continue to use the device at home ,at least twice daily, for the first six (6) days of chemotherapy Cycles 1 and 2. Prior to the first chemotherapy infusion in Cycle 3, all subjects in the study regardless of treatment assignment will have the option of using the Chemo MouthpieceTM for subsequent cycles.