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NCT ID: NCT03403439 Not yet recruiting - Healthy Clinical Trials

This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood

Start date: February 2, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of this trial is to investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the 4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral administration in healthy male subjects.

NCT ID: NCT03403348 Not yet recruiting - Healthy Clinical Trials

A First-In-Human Study of Orally Administered JNJ-64417184 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses, and the Antiviral Activity of Multiple Doses in a Respiratory Syncytial Virus (RSV) Challenge Study in Healthy Participants

Start date: January 29, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of single and multiple oral doses of JNJ-64417184 administered to healthy participants and the antiviral effect of multiple oral doses of JNJ-64417184 compared to placebo in participants infected through inoculation with respiratory syncytial virus (RSV)-A Memphis 37b (Part 4).

NCT ID: NCT03402555 Not yet recruiting - Healthy Clinical Trials

Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software

Start date: January 2018
Phase: N/A
Study type: Observational

To observe the stool patterns of healthy infants/toddlers by collecting a panel of stool images for the development of a software

NCT ID: NCT03400995 Not yet recruiting - Healthy Clinical Trials

A Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of AK0529

Start date: February 2018
Phase: Phase 1
Study type: Interventional

This phase I study is to assess the mass balance recovery after a single oral dose of [14C]-AK0529 in healthy male subjects.

NCT ID: NCT03398473 Not yet recruiting - Healthy Clinical Trials

A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects

Start date: January 25, 2018
Phase: Phase 1
Study type: Interventional

This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.

NCT ID: NCT03398447 Not yet recruiting - Healthy Clinical Trials

High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

Start date: March 2018
Phase: N/A
Study type: Interventional

The aim of this study is to show Endocuff Vision could improve insertion because during loop withdrawal the cuff tends to stabilize the position of the tip, preventing its backward movement and speeding loop removal. Similarly, during inspection the main goal is to evaluate the proximal sides of folds and flexures. The process is made easier and quicker by the device. Third, during polypectomy, Endocuff Vision helps to stabilize the position and the scope tip.

NCT ID: NCT03395119 Not yet recruiting - Healthy Clinical Trials

Efficacy of Fish Oil or Olive Oil Supplementation on the Health Effects of Ozone Exposure in Healthy Young Subjects

OMEGOZ
Start date: January 2018
Phase: Phase 1
Study type: Interventional

Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollution. One of the common air pollutants, ozone, has been shown to induce oxidative stress and inflammation in the cardiovascular and respiratory systems. This proposed study is to examine the efficacy of fish oil and olive oil in modulating cardiovascular and pulmonary functions after ozone exposure. The objective is to understand the mechanistic basis for the health effects of ozone relative to those air pollutants. Treatment groups will include forty healthy young adults who will be given dietary supplementation of fish oil or olive oil. A control group will consist of 20 healthy volunteers who will receive no supplements. After 4 weeks, subjects will be exposed to clean air for 2 hours on the first day, then ozone for 2 hours on the second day. Cardiac rhythm, pulmonary function, vascular responses, endothelial function, and markers of coagulation and airway inflammation pre- and post- ozone exposure will be measured. This study is designed to build on the previous nutritional supplement interventional studies (UNC IRB # 07-0190 and UNC IRB # 11-1807), in order to understand the mechanism of action of particulate pollutants in comparison to that of ozone, a known oxidant air contaminant. Participants: A total of sixty healthy 18-35 year-old male and female subjects will be involved in the study. Procedures (methods): Forty healthy young adults will receive dietary supplementation consisting of fish oil or olive oil for 4 weeks. The control group includes 20 healthy volunteers who will receive no supplements in the study. After 4 weeks of supplementation or control regiment, each subject will be exposed to clean air for 2 hours on the first day, then ozone for 2 hours on the second day.

NCT ID: NCT03394963 Not yet recruiting - Healthy Clinical Trials

Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index

Start date: June 1, 2018
Phase: N/A
Study type: Observational

Among several factors contributing to the occurrence of undernutrition, micronutrient deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important factors that need to be addressed to tackle the burden in low- and middle-income countries. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines as well as monitor the adherence of the population with the guidelines. The aim of this study is to generate evidence that will help the development and validation of food-based dietary guidelines and a healthy eating index for Ethiopia. The method to develop Ethiopian food-based dietary guidelines is adapted from the 2015 Dutch food-based dietary guidelines and the Dutch healthy diet index development and validation process, and the 1998 FAO/WHO preparation and use of food-based dietary guidelines. A multidisciplinary technical working will be established to develop FBDGs. The working group will identify key messages for the guidelines that can address priority diet-related public health problems in Ethiopia based on the evidence that will be generated by the PhD student from Wageningen University and Research. The evidence generation will begin by identifying top ten diet-related diseases that lead to high morbidity and mortality in 2016. The nutrition situation (nutritional status, dietary pattern, and nutrient gaps) analysis will be conducted to define the objectives of FBDGs. A systematic review will be conducted by formulating research questions to address the objectives of the FBDGs. The FBDGs will be translated for a specific population subgroup using linear mathematical programming and validated for cultural appropriateness, acceptability, consumer understanding and practicality of the messages. Focus group discussions and key informant interviews will be conducted to validate the FBDGs. The most recent Ethiopian national food consumption survey data collected in 2011 will be used to develop a healthy eating index (HEI). The selection of a healthy eating component of HEI will be done based on the FBDGs. Validation of a healthy eating index will be conducted by comparing the HEI score based on 24-hour recall with the HEI score based on food frequency questionnaire for population characteristics and association with micronutrient intake with or without adjusting for energy and anthropometric measurement. Developing short food frequency questionnaire (FFQ) that can be scored with the index for dietary counseling and public health practice as well as dietary gap assessment for policy recommendation will be part of the study. Validation of FFQ will be conducted by collecting primary data among women of reproductive age in 500 households in rural and urban areas of Ethiopia. The data will be analyzed using the latest version of STATA, SPSS, and NVIVO software. Correlations and other appropriate advanced statistical technique will be applied as needed to answer the objectives of the study. Ethical approval will be received from the medical ethical committee of Wageningen University and Research and scientific and ethical review office of Ethiopian Public Health Institute. This Ph.D. research is supported by the Food Systems for Healthier Diets flagship of the CGIAR- Agriculture for Nutrition and Health Programme coordinated by International Food Policy Research Institute. Food and Agriculture Organization (FAO) and Ethiopian Public Health Institute are collaborators of this project to develop the FBDGs.

NCT ID: NCT03393208 Not yet recruiting - Healthy Clinical Trials

Glucophage Immediate Release (GIR) China Bioequivalence Study

Start date: January 8, 2018
Phase: Phase 1
Study type: Interventional

The study will assess the bioequivalence between single doses of glucophage immediate release (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.

NCT ID: NCT03385590 Not yet recruiting - Healthy Clinical Trials

Feasibility and Acceptability of a Soy-fiber-maize Complementary Food in Malawi.

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this intervention study is to assess the feasibility and acceptability of soy-fiber-maize versus soy-maize complementary foods on bowel movement frequency, transit time, growth, gastrointestinal symptoms, microbiota composition and activity.