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NCT ID: NCT06247735 Recruiting - Clinical trials for Primary Biliary Cholangitis

Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

Start date: January 26, 2024
Phase: Phase 2
Study type: Interventional

Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

NCT ID: NCT06247696 Recruiting - Sleep Disturbance Clinical Trials

Sweet Scents to Sweet Dreams

SSS
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of herbal pillows on sleep and quality of life in a healthy population using actigraphy, validated questionnaires and daily diary logs. The goal of this study is to improve sleep and quality of life using herbal and Ayurveda/holistic-based botanical pillows.

NCT ID: NCT06247644 Completed - Healthy Volunteers Clinical Trials

BD Evolve™ On-body Injector's Adherence Performance - Wear Study

Start date: February 14, 2024
Phase: N/A
Study type: Interventional

An On-body Injector is a small device, which is adhered to the skin with a sticky patch. The injector is intended to deliver a small volume of medicine from a reservoir inside the device into the skin via a small catheter. The drug delivery happens after a period of time, as programmed into the device, and afterwards the device can be removed. The purpose of this study is to evaluate how well the BD Evolve™ On-body Injector adhesive pad sticks to the skin and how the adhesive keeps the device in position when worn on the arm during normal daily activities for 28 hours. As this study only evaluates the performance of the adhesive pad of the OBI, no injection will be performed, and the device will not be filled with any fluid. The injection capability will be disabled.

NCT ID: NCT06247553 Recruiting - Stroke Clinical Trials

To Develop a Walking Exercise Program for Non-ambulatory Stroke Survivors

Start date: February 2, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a gait (walking) training program in non-ambulatory (unable to walk) chronic stroke survivors. The main question it aims to answer is: • Will gait training improve the cardiovascular system in non-ambulatory chronic stroke survivors better than a sitting leg cycling exercise? Participants will walk on a treadmill with a partial body-weight support system and the gait training device. Researchers will compare with a leg-cycling exercise to see if there are significant differences in resting heart rate, systolic blood pressure (SBP), and A1c levels in the blood.

NCT ID: NCT06247540 Withdrawn - Richter Syndrome Clinical Trials

Venetoclax, Rituximab and Nivolumab in Combination for the Treatment of Richter's Transformation Arising From Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Start date: March 29, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well venetoclax, rituximab and nivolumab works in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with Richter's transformation. Richter's transformation can be described as the development of an aggressive lymphoma in the setting of underlying CLL/SLL that has a very poor prognosis with conventional therapies and represents a significant unmet medical need. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as rituximab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving venetoclax, rituximab and nivolumab together may work better than the conventional intensive immunochemotherapy to improve disease control in patients with Richter's transformation arising from CLL/SLL.

NCT ID: NCT06247514 Enrolling by invitation - Clinical trials for Disordered Eating Behaviors

The BEET Diabetes Feasibility Trial

Start date: January 5, 2024
Phase: N/A
Study type: Interventional

Disordered eating behaviors (DEBs, e.g., binge eating or restrictive eating) can significantly impact type 2 diabetes (T2D) self-management and engagement in treatment for diabetes. Managing DEBs is a treatment component in diabetes self-management; however, it is not often the primary focus, and trained behavioral health providers are inconsistently involved in comprehensive diabetes management. This study plans to pilot two behavior change programs for disordered eating in T2D and gather information on factors that predict successful adoption and implementation in real-world clinical settings.

NCT ID: NCT06247488 Completed - Abuse Potential Clinical Trials

Evaluation of Abuse Potential of HORIZANT Taken Alone and With Oxycodone in Healthy, Nondependent Recreational Opioid Users

Start date: January 31, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.

NCT ID: NCT06247462 Completed - Acute Kidney Injury Clinical Trials

Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat

Start date: June 1, 2023
Phase: Phase 1
Study type: Interventional

The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.

NCT ID: NCT06247345 Recruiting - Alzheimer Disease Clinical Trials

A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01

Start date: January 30, 2024
Phase: Phase 1
Study type: Interventional

This is a Phase Ia/Ib, two-part, randomized, placebo-controlled, double-blinded, first in human(FIH) study to evaluate the safety, tolerability, PK, and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI due to AD and mild AD in Part 2. The study includes 2 parts: Part 1 (single ascending dose [SAD] and Part 2 (multiple ascending dose [MAD]).

NCT ID: NCT06247267 Recruiting - Hypogonadism Clinical Trials

The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population

Start date: March 1, 2019
Phase:
Study type: Observational

It has been known that both estrogen and testosterone are the major sex steroids regulating bone metabolism and other physiological changes in both male and female, respectively. In postmenopausal women, osteoporosis is a major concern secondary to the lack of estrogen. These patients also experience a number of physiological changes that affect their life permanently to include hot flashes, irritability, difficulty concentrating, depression and mental confusion. In hypogonadal men, testosterone deficiency could lead to higher prevalence of depression, osteoporosis, fracture and frailty. Given the new military policy starting to support treatment for gender identity dysphoria military personnel, the number of transgender patients in our Endocrinology clinic has been slowly increasing over the past several months. These patients will require either testosterone replacement therapy or estrogen therapy to achieve their desired sexual characteristics. However, as mentioned above, the lack of estrogen or testosterone in female and male, respectively, could cause several issue in their body composition, cognitive function and quality of life. We designed this prospective case-control study to include patients with hypogonadism and the transgendered populations to learn about the long-term effects of these hormonal replacement therapies on bone density, fractures, memory/cognitive function and quality of life. This is a repetitive measures study taken at baseline, 6-months, and 12-months for three groups consisting of at least 75 subjects. The study will involve 3 arms, i.e. Group 1 primary/secondary untreated hypogonadism, Group 2 male-to female (MTF), and Group 3 female-to-male (FTM) participants that are planning to start hormone replacement therapy as per standard clinical guidelines.