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NCT ID: NCT05554237 Completed - Healthy Clinical Trials

A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People.

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

The purpose of this clinical trial is to learn about the pharmacokinetics, safety and tolerability of various single- and multiple-doses of CTB+AVP in healthy adult participants. CTB+AVP is a study medicine that is being developed to treat people with complicated urinary tract infections. This study is seeking healthy adult male and female participants, 18-60 years of age, with a body weight > 50 kg and a BMI of 17.5 to 30.5 kg/m2. Participants in Part-1 of the study will receive increasing single doses of CTB and/or AVP. Participants in Part-2 will receive increasing multiple doses of CTB+AVP three times a day for 7 days. The study team will monitor how each participant is doing with the study treatments via close monitoring in an in-patient setting. Experiences of people receiving CTB+AVP will be compared to those of people who do not. This will help determine if CTB+AVP is safe and well-tolerated at each dose of the study medicine. Participants will take part in this study for a maximum of 12 weeks for Part-1 (up to 4 weeks for screening, up to 3 weeks of taking study medicine and up to 5 weeks for safety follow-up visit) and for a maximum of 10 weeks for Part-2 (up to 4 weeks for screening, up to 1 week of taking study medicine and up to 5 weeks for safety follow-up visit). During the duration of the study, blood samples for study medicine levels, and various measures for monitoring safety such as blood samples for clinical laboratory measurements, electrocardiograms and vital sign measurements will be taken.

NCT ID: NCT05552196 Completed - Healthy Clinical Trials

A Study of Ponesimod in Healthy Adult Participants

Start date: October 18, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of steady-state carbamazepine (CBZ; a strong pregnane X receptor [PXR] agonist) on the pharmacokinetics (PK) of ponesimod following a gradual up-titration regimen in healthy adult participants.

NCT ID: NCT05544786 Completed - Clinical trials for Biological Availability

Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants.

Start date: September 28, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to estimate the relative bioavailability (rBA) of nirmatrelvir/ritonavir oral powder in 3 different food vehicles relative to the Paxlovid® tablets under fasted condition in healthy adult participants, and to estimate the effect of food on the rBA of the nirmatrelvir/ritonavir oral powder formulation. The study will also assess the safety, tolerability, and palatability of nirmatrelvir/ritonavir oral powder in healthy adult participants.

NCT ID: NCT05543096 Completed - Clinical trials for Coronary Artery Disease

PMCF Study for Cardiology Access Procedures

Start date: May 23, 2022
Phase:
Study type: Observational

This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the procedure and to provide a reasonable enrolment period for the required data to be collected. The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 200 patients who underwent an endovascular intervention within standard-of-care (SOC) where at least 1 of the products (named above) from Cordis US Corp were used.

NCT ID: NCT05542732 Completed - Hypoxia Clinical Trials

Accuracy of CardioWatch 287-2 During Profound Hypoxia

ACW2
Start date: June 4, 2022
Phase: N/A
Study type: Interventional

In an individual's SpO2 range from 100 to 73 %, this study calibrates and evaluates the accuracy of SpO2 measurement by CW2 in comparison to reference pulse oximeter (Nellcor PM10) or CO-oximetry, Pulse rate (PR) and respiratory rate (RR) were calibrated based on the same Nellcor equipment and the frequency of end-tidal CO2 respectively.

NCT ID: NCT05538312 Completed - Healthy Clinical Trials

A Study to Understand the Effect of Itraconazole on the Levels of a Study Medicine Called ARV-471 in Healthy Adults

Start date: February 23, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to understand if a strong CYP3A4 inhibitor (itraconazole) affects how ARV-471 is processed and eliminated in healthy adults. All participants in this study will receive one dose of ARV-471 alone by mouth in Period 1. In Period 2, everyone will receive itraconazole by mouth once a day for multiple days. Participants will also receive one dose of ARV-471 by mouth. The levels of ARV-471 in Period 1 will be compared to the levels of ARV-471 in Period 2 to determine if the CYP3A4 inhibitor affects how ARV-471 is processed differently in healthy adults.

NCT ID: NCT05537649 Completed - Clinical trials for Postprandial Glycemic Responses

Glycemic Responses of an Innovative Oat Porridge

GREAT
Start date: June 23, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate whether enzymatic modification of starch in a food product using amylomaltase induces a lower glycemic response in healthy subjects compared to its unmodified counterpart.

NCT ID: NCT05537168 Completed - Clinical trials for Cardiopulmonary Bypass

Bayesian Networks in Pediatric Cardiac Surgery

Start date: September 17, 2022
Phase:
Study type: Observational

Pediatric cardiac surgery with cardiopulmonary bypass is associated with significant morbidity and mortality. Also score systems for risk factors, such as Risk Adjustment for Congenital Heart surgery (RACHS 1) score or the ARISTOTLE score, have been developed, outcome prediction remains difficult. New mathematical methods using deep neural networks associated with Bayesian statistical methods have been developed to give a better understanding of the complex interaction between different risk factors, to identify risk factors and group them in related families. This method has been successfully used to predict mortality in dialysis patient as well as to better describe complex psychiatric syndromes. The primary hypothesis of this study is that the use of these tools will give a better understanding on the factors affecting outcome after pediatric cardiac surgery. A network analysis using Gaussian Graphical Models, Mixed Graphical models and Bayesian networks will be used to identify single or groups of risk factors for morbidity and mortality after pediatric cardiac surgery under cardiopulmonary bypass.

NCT ID: NCT05536778 Completed - Clinical trials for Strength and Endurance

Shoulder Endurance Assessment in Upper Limb Athletes

Start date: October 15, 2022
Phase:
Study type: Observational

The objective of this study is to explore the relationship between two different "fatigue tests" (Xco Endurance Test and Shoulder Endurance Test) and strength/endurance of shoulder rotators muscles, measured with an isokinetic device. The tests will be organized during two different sessions, in a randomized order. One session will be dedicated to isokinetic evaluation. The other one will include the performance of the two functional tests.

NCT ID: NCT05535075 Completed - Vancomycin Clinical Trials

Model-informed Precision Dosing of Vancomycin in Adults

Start date: November 12, 2021
Phase: Phase 4
Study type: Interventional

The overall objective of this project is to investigate the utility of model-informed precision dosing (MIPD) of vancomycin in non-critically ill adults. This evaluation includes a comparison with the more standard approach on clinical and patient-oriented measures.