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Safety Issues clinical trials

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NCT ID: NCT05655000 Recruiting - Safety Issues Clinical Trials

Neonatal Thymus Transplantation in Humans

SUPERTHYM
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to demonstrate the safety of the neonatal thymus transplant in an adult patient. The main questions it aims to answer are: - Is the neonatal thymus transplant a safe procedure? - What is the adverse event profile of the neonatal thymus transplant? This is a single-subject study; thus, there will not be comparison groups. The participant will receive multidisciplinary supportive care before, during, and after the procedure.

NCT ID: NCT05648799 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics, Safety and Efficacy Study of GP30341 (GEROPHARM, Russia) in Healthy Volunteers and Outpatients With COVID-19

Start date: March 17, 2022
Phase: N/A
Study type: Interventional

Pharmacokinetics, safety and efficacy study of GP30341, 200 mg capsules (GEROPHARM LLC, Russia) in healthy volunteers and patients with novel coronavirus infection 2019 (COVID-19) with a high risk of adverse outcome

NCT ID: NCT05633147 Completed - Pharmacokinetics Clinical Trials

Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam

Start date: November 27, 2022
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label, fixed design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein P (PgP), leads to an effect on the systemic exposure to linaprazan glurate and linaprazan and whether there is an effect on the pharmacokinetics of clarithromycin after a single dose of linaprazan glurate. Part II is designed to evaluate the effect of repeated doses of linaprazan glurate on the pharmacokinetics (PK) of a sensitive substrate of CYP3A (midazolam).

NCT ID: NCT05608889 Recruiting - Health Behavior Clinical Trials

Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being

Start date: November 9, 2022
Phase: N/A
Study type: Interventional

Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals. The primary outcomes relate to behaviors promoted by the program: being mindful/reduced stress/improved mood; healthier eating; more physical activity; greater restorative sleep; improved work-life balance and greater positive feelings about the organization.

NCT ID: NCT05585762 Completed - Aging Clinical Trials

Buck Institute Ketone Ester RCT

BIKE
Start date: November 28, 2022
Phase: N/A
Study type: Interventional

This study is to investigate the tolerability and safety of a ketone promoting ingredient, called a ketone ester (KE), in healthy older adults. This randomized, double-blind, placebo-controlled trial aims to characterize the tolerability and safety of daily consumption of the KE in healthy older adults (over 65 years old) over 12 weeks. Study participants will complete Beverage Tolerability Questionaires (BTQ) to rate any side side effects throughout the study. Safety will also be assessed by collection of blood and urine samples, vital signs, body weight, and monitoring of adverse events (AEs). The study will also collect pilot data to explore possible effects of KE on physical function, cognitive function and quality of life. The findings of this study will be used to facilitate future mechanistic studies of KE in aging.

NCT ID: NCT05585463 Completed - Safety Issues Clinical Trials

Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)

ACUSAFE2021
Start date: September 1, 2019
Phase:
Study type: Observational

This study aims to demonstrate the safety of intracutaneous needles in pediatric cancer patients. For this, a two-year retrospective study will be carried out to determine the incidence of adverse effects related to acupuncture and the use of intracutaneous needles in the patient in active treatment and survivor.

NCT ID: NCT05583006 Recruiting - Clinical trials for Patient Satisfaction

Tenofovir Alafenamide Switch Therapy in Chronic Hepatitis B

Start date: November 6, 2023
Phase:
Study type: Observational

Chronic hepatitis B (CHB) patients may be unsatisfied to entecavir (ETV) therapy due to the inconvenience in drug taking, i.e., fasting for more than 2 hours and/or dose adjustment according to estimated glomerular filtration rate (eGFR). However, tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with CHB, and is convenient in drug taking, i.e., once daily regardless food taking and renal function.Therefore,TAF can be a good option in CHB patients who are unsatisfied to ETV therapy. The aim of this prospective cohort study is to assess the improvement on satisfaction (including drug adherence) of TAF switch therapy in CHB patients who are unsatisfied to ETV therapy. In addition, with expected adherence improvement in TAF switch therapy, the efficacy of TAF switch therapy may be improved, and the efficacy benefits can be evaluated by the changes of some novel biomarkers, such as HBV core-related antigen (HBcrAg). The investigators therefore aim to conduct a prospective cohort study of TAF switch therapy for CHB patients who are unsatisfied to ETV therapy.

NCT ID: NCT05580172 Recruiting - Safety Issues Clinical Trials

Phase 1 Study of Oral RH324 in Advanced Non-Small Cell Lung Cancer

Start date: June 1, 2022
Phase: Phase 1
Study type: Interventional

Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer

NCT ID: NCT05575700 Recruiting - Postoperative Pain Clinical Trials

Safety of Ibuprofen After Major Orthopaedic Surgeries

PERISAFE
Start date: April 17, 2023
Phase: Phase 4
Study type: Interventional

Safety of an eight-day treatment with ibuprofen after primary hip and knee arthroplasties.

NCT ID: NCT05573854 Completed - Safety Issues Clinical Trials

Residual Gastric Volume After the Ingestion of Supplements Containing Carbohydrates and Whey Protein

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Oral supplements (OS) containing carbohydrates are being used 2h before anesthesia. The addition of a nitrogen source would improve these drinks designed for the abbreviation of preoperative fasting. The gastric emptying of an oral supplement containing whey protein in addition to carbohydrates was investigated. This is a randomized crossover study including six healthy young volunteers who were submitted to abdominal MRI in 3 phases: 1) after a overnight fast, 2) after drank 200 mL of an OS containing whey protein and carbohydrates (no lipids), and 3) 3h after ingestion of the mentioned OS. The gastric residual volume (GRV) will be evaluate by MRI. The overall findings would allow us to conclude whether the GRV, assessed by MRI, in healthy young volunteers after three hours of the ingestion of 200 ml of an oral supplement containing carbohydrates associated with whey proteins is similar to the GRV found after an overnight fast. This pilot study will add important information to allow future randomized trials including an arm with patients undergoing elective surgical procedures with a 3h fasting after the ingestion of an OS containing whey protein and carbohydrates.