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NCT ID: NCT05051553 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Bioavailability of Fedratinib When Administered in Different Ways to Healthy Adult Participants

Start date: September 21, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.

NCT ID: NCT05050682 Completed - Healthy Clinical Trials

Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants

Start date: October 7, 2021
Phase: Phase 1
Study type: Interventional

This open-label, single dose study in approximately 5 healthy male and female (of non childbearing potential only) participants has been designed to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of PF 07304814 administered at a dose of 500 mg [14C] PF-07304814 containing approximately 420 nCi [14C] PF-07304814 as a constant-rate, continuous IV infusion over 24 hours

NCT ID: NCT05050578 Completed - Refractive Errors Clinical Trials

Clinical Assessment of Two Reusable Silicone Hydrogel Contact Lenses

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.

NCT ID: NCT05050448 Completed - Knee Osteoarthritis Clinical Trials

Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

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

The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.

NCT ID: NCT05050318 Completed - Healthy Volunteers Clinical Trials

Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

Start date: September 8, 2021
Phase: Phase 4
Study type: Interventional

This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.

NCT ID: NCT05050188 Completed - Erosive Esophagitis Clinical Trials

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008

Start date: June 24, 2021
Phase: Phase 1
Study type: Interventional

This will be a Phase I, randomized, double-blind, positive- and placebo-controlled study to evaluate the safety, tolerability, and PK/PD of multiple oral doses of H008 in healthy adult subjects. Two dose levels of H008 at 20 mg and 40 mg will be studied in two sequential cohorts. Each cohort will be enrolled with 12 subjects (8 on H008, 2 on placebo and 2 on positive control drug). Subjects are only allowed to participate in one of the two cohorts. Both the investigational product and placebo will be given in a double blinded manner, while the positive control drug will be given in an open-label manner.Dose escalation to the next cohort will be permitted only when safety data until follow-up and PK data until 48 hours post-last dose, from all subjects in previous cohorts are reviewed, and the investigational product is deemed well tolerated. The study will consist of a screening period, a baseline period, a 7-day repeated-dose period and a safety follow-up period.

NCT ID: NCT05049733 Completed - Cannabis Clinical Trials

The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A

Start date: March 7, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the pharmacokinetics and pharmacodynamics of a hemp-derived oral product containing cannabidiol (CBD) and cannabidiolic acid (CBD-A) at a 1:1 ratio.

NCT ID: NCT05049590 Completed - Acute Kidney Injury Clinical Trials

Acute Normovolemic Hemodilution in Complex Cardiac Surgery

ANH
Start date: February 28, 2022
Phase: Phase 3
Study type: Interventional

Postoperative bleeding in cardiac surgery is a frequent complication, and cardiac surgery utilizes 15-20% of the national blood supply. Packed red blood cells (pRBCs) are associated with worse short and long term outcomes. For each unit transfused, there is an additive risk of mortality (death) and cardiac adverse events. Despite current guidelines and numerous approaches to bleeding reduction, >50% of the patients undergoing cardiac surgery receive transfusions. Acute normovolemic hemodilution (ANH), a blood conservation technique that removes whole blood from a patient immediately prior to surgery, could be a valuable method to reduce transfusion in complex cardiac surgery. At the University of California, Los Angeles (UCLA), ANH is routinely utilized in patients who refuse allogenic blood transfusions such as Jehovah's Witnesses. ANH has been shown to be safe with minimal risk to patients. ANH has been studied in simple cardiac surgery, such as coronary artery bypass grafting, however it has not been studied in complex cardiac surgery, such as aortic surgery and adult congenital heart disease. ANH has been demonstrated to reduce pRBC transfusion in lower risk cardiac surgery without any significant complications. Complex heart surgery utilizes more blood products. This study could identify the benefits of ANH in a higher risk surgical group.

NCT ID: NCT05049343 Completed - Healthy Volunteer Clinical Trials

Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants

Start date: September 21, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.

NCT ID: NCT05049291 Completed - Dementia Clinical Trials

Pilot Study of an Advance Care Planning Intervention Among Persons With Dementia

Start date: November 10, 2022
Phase: N/A
Study type: Interventional

Advance care planning allows people to have their wishes taken into account even in the advanced stages of the persons' condition and at the end of life when the person may be unable to communicate. However, a recent review found an absence of high-quality guidelines for advanced care planning in dementia care. Since few evidence-based resources exist, the investigators propose a study to generate, refine, and pilot test an education information sheet designed to promote advanced care planning among families of persons with dementia.