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NCT ID: NCT05520827 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How Different Doses of BI 1584862 Are Tolerated and How BI 1584862 is Taken up in the Body With or Without Food

Start date: September 29, 2022
Phase: Phase 1
Study type: Interventional

Single Rising Dose (SRD) part: The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses. Food Effect (FE) part: The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.

NCT ID: NCT05520580 Completed - Post Operative Pain Clinical Trials

Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of the mother's active pushing during cesarean delivery.

NCT ID: NCT05517746 Completed - Endometriosis Clinical Trials

Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants

Start date: December 18, 2019
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus. The study treatment, BAY2395840, is being developed to help block certain proteins from causing inflammation and pain in people with endometriosis. But, this is the first time that researchers will study BAY2395840 in humans. In this study, the researchers will learn how safe BAY2395840 is for the participants to take. They will also learn what happens to BAY2395840 in the body. The study will include about 56 healthy adult men. All of the participants will take increasing doses of BAY2395840, or a placebo. A placebo looks like a treatment but does not have any medicine in it. Some of the participants will take their study treatment 1 time under diet 1 conditions. The other participants will take their study treatment 7 times with diet 1 or diet 2. The participants will take BAY2395840 or the placebo as tablets or as a liquid by mouth. The participants will stay at the study site for up to 11 days . After that, they will visit the study site 1 more time. Each participant will be in the study for up to about 14 weeks. During the study, the doctors will collect blood and urine samples and check the participants' overall health and heart health. The participants will answer questions about how they are feeling, what medications they are taking, and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05516316 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Clinical Trial Comparing the Pharmacological Effects of EP395 With Placebo in Healthy Adults

Start date: October 11, 2022
Phase: Phase 1
Study type: Interventional

This study aims to assess the effect of EP395 against an induced inflammation of the lung. In addition, further data about the safety and tolerability of EP395 will be collected. To investigate the efficacy of EP395 at the end of the treatment with EP395 or placebo (dummy), all participants will inhale a lipopolysaccharide (a molecule composed of sugar and fat) that artificially induces an acute inflammation of the airways. It is assumed that participants who received EP395 will show less inflammation of the airways than participants who received placebo.

NCT ID: NCT05515510 Completed - Oral Health Clinical Trials

Acceptance and Efficacy of a Digital Application Among Parents to Control Early Childhood Caries

FU-APP
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Few educational oral health applications, directed to the preschool children under the age of six years are available world-wide. The overall aim of this study is to evaluate the acceptance and efficacy of a digital application in improving evidence based oral hygiene knowledge among parents of young children to control Early Childhood Caries (ECC). This study is split into two parts, the first one is aimed to understand the acceptance, usability and parental perception about a digital application being used to promote the evidence based oral hygiene knowledge among parents of young children to control ECC. In a second phase (randomised clinical trial) the additional effect and acceptance of the digital application, and efficacy in improving parental knowledge, behaviour and self-reported practices/attitudes related to the oral health preventive measures will be presented.

NCT ID: NCT05515432 Completed - Healthy Volunteers Clinical Trials

A Study to Learn How the Study Treatment BAY3283142 Taken as Single Dose by Mouth Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Reduced Kidney Function Compared to Participants With Normal Kidney Function of Similar Age, Gender, and Weight

Start date: August 11, 2022
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD). The kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. High blood pressure makes it more likely that the CKD gets worse. The study treatment BAY3283142 is under development for treating CKD. It activates a protein called soluble guanylate cyclase (sGC) that generates cGMP - a molecule that relaxes blood vessels and is thought to have beneficial effects in CKD. The participants do not benefit from this study. However, the study will provide information on how to use BAY3283142 in subsequent studies in people with CKD. In previous studies, BAY3283142 was studied in participants with normal kidney function. As kidneys play a role in removal of drugs from the body, the degree of kidney function could influence the amount of BAY3283142 in the blood. Higher amounts may occur in people with reduced kidney function. Therefore, the main purpose of this study is to learn how the study treatment BAY3283142 moves into, through, and out of the body in participants with mild to severe reduction of kidney function compared to matched participants with normal kidney function. To answer this, the researchers will compare: - the (average) total level of BAY3283142 in the blood (also called AUC). - the (average) highest level of BAY3283142 in the blood (also called cmax) between the different groups. Participants will be in one of four groups based on how much their kidney function is reduced (mild, moderate, severe, end stage kidney disease) or in the control group. All participants will take a single dose of BAY3283142 as tablet by mouth. Each participant will be in the study for approximately 4 weeks including an in-house stay of 6 days (with 5 overnight stays). In addition, a screening visit to the study site before the in-house stay is planned. During the study, the study team will: - check vital signs - do physical examinations - take blood and urine samples - examine heart health using an electrocardiogram (ECG) - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05507450 Completed - Dengue Virus Clinical Trials

Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)

Start date: September 7, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.

NCT ID: NCT05507437 Completed - Clinical trials for Acute Kidney Injury Due to Sepsis

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury

Start date: November 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

NCT ID: NCT05505240 Completed - Clinical trials for Resting Energy Expenditure

Influence of Ambient Temperature on Resting Energy Expenditure of Healthy Adults

Start date: November 21, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the influence of four different ambient temperatures (18, 22, 28, 38°C) on the resting energy expenditure of healthy adults by respiratory gas analysis. It is assumed that the resting energy expenditure is higher at 18°C and 38°C than at the temperatures in between.

NCT ID: NCT05503199 Completed - Clinical trials for Aortic Valve Stenosis

Comparison of Strategies for Vascular Access Closure After Transcatheter Aortic Valve Implantation

ACCESS-TAVI
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The ACCESS-TAVI trial is an investigator-initiated, prospective, randomized, multicenter, open-label clinical trial. The objective of the trial is to compare two different vascular closure device strategies for large bore vascular access following transfemoral transcatheter aortic valve implantation with regard to safety and efficacy.