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The purpose of this clinical study is to validate the SpO2 accuracy of the Medline ReNewal pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the ReNewal sensors. It is required that the Accuracy Root Mean Square (ARMS) performance of the ReNewal pulse oximetry sensors will meet a specification of 3 or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.
This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-42165279 in healthy Japanese male participants after single and multiple oral dose administration.
This Thorough-QT (TQT) study in healthy volunteers will be conducted in two phases. Phase One will be used to identify a safe supratherapeutic dose to be used in the TQT study (Phase Two). Phase Two will be a 4-way crossover TQT study. Thirty-two subjects will receive all 4 of the following treatments in randomized sequence. 1. meropenem-vaborbactam 4 g (meropenem 2 g- vaborbactam 2 g) therapeutic dose infused intravenously over 3 hours 2. meropenem-vaborbactam supratherapeutic dose to be determined infused intravenously over 3 hours. 3. Placebo (normal saline) to match meropenem-vaborbactam volume infusion over 3 hours 4. Moxifloxacin 400 mg positive control (oral; open-label)
The objective of the study is to compare the bioavailability of a generic product of paracetamol (immediate-release) with that of a reference product when administered to healthy volunteers under fasting condition. The test product is Fortolin Tab 500mg manufactured by Fortune Pharmacal Co. Ltd., and the reference product is Panadol Caplet 500mg manufactured by GlaxoSmithKline (Dungarvan) Ltd. The plasma pharmacokinetic data of paracetamol obtained from two formulations will be used to evaluate the interchangeability of the products.
The trial aims to analyse changes in the microbiome of the lower airways after smoking cessation. Microbiome analyses (upper airway swabs, bronchoalveolar lavage, transbronchial brushing) are conducted in smokers before and 6 weeks after smoking cessation. Never smokers serve as a control group and undergo the same sampling procedures once.
To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension 200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg) of "Reckitt Benckiser Healthcare International Ltd, .", UK in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety
This study is designed to evaluate the impact of team-based goals and performance-based incentives for community-based health workers on health-promoting behaviors among women related to reproductive, maternal, newborn and child health and nutrition in Bihar, India. The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and implemented from 2012 to 2014. Health sub-centers in the catchment areas of five blocks (sub-districts) of the district of Bengusarai were randomly assigned to treatment or control arms (38 sub-centers were assigned to each). Data were collected in the Intervention and Control areas from mothers of infants 0-12 months at baseline and at 2.5-year follow-up, to assess the intervention's effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess outcome effects in this quasi experimental study. The TBGI intervention was implemented in areas where the BMGF-funded Ananya program (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact is of the [TBGI intervention + Ananya] versus [Ananya alone]. The Ananya program was developed and implemented via a partnership of BMGF and the Government of Bihar. The ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to improve maternal and neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014. Eight focal districts in western and central Bihar received Ananya, while 30 districts did not.
Background: Single heel-rise test (SHRT) is a method of assessing the strength and endurance of plantar-flexors manually. Single heel-rise test also known as calf rise test, is a method of assessing the strength of plantar-flexor. The test was first done to determine the integrity of calf muscle. There are few studies which has established the reliability and normative value of heel-rise test in adults. But till date, there is no documented evidence of normative value of heel-rise test in children. Aim: The study is focused to derive reliability, validity and normative value of unilateral heel-rise test in children of age group 8-12 years. Methods: The study will recruit healthy school-going children of 8-12 years age. Any pathology which can limit or interfere with the test outcome will be excluded. The samples will be collected by stratified sampling technique. Procedure of test will be demonstrated prior to the test. Heel raising and lowering will be performed until child feels fatigue. Test will be performed on both the lower extremities individually. Data analysis: Test will be assessed on both the heel individually. Two sessions will be conducted by the same rater on same individual for intra-rater reliability, and another rater will assess the test on same individual for establishing inter-rater reliability. Validity of the test will be assessed by dynamometer. Normative value of the test is determined by deriving the mean of test-values for each age group.