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Filter by:Unhealthy lifestyle habits during the childhood could negatively impact the health status actual and during the later stages of life. The School represents the major Institution to implement actions aim at promoting healthy lifestyles habits. The Joint School-Health Project of the Neapolitan Child aimed at assessing the impact of a health education programme to improve lifestyle habits during the childood. To evalute the effects of this educational programme, the dietary habits, the sleep hours, the hours spent in sedentary behaviors (tv, smartphone) and the hours of physical activity will be evaluate at the baseline and at the end of the programme.
Intake of the green tea catechin epigallocatechin (EGCG) increased fat oxidation during walking. It is also known to reduce blood pressure and improve body composition. This research will expand the insight on the effects by Matcha green tea supplementation and address the effects on heart rate variability, substrate oxidation at rest, and cardiovascular responses at rest in addition to metabolic and physiologic responses for a 1-hr walk in healthy females.
Primary objective: - to investigate the effect of food on the bioavailability of DF 2156Y after single dose administration of 400 mg of ladarixin to healthy male and female volunteers under fed and fasting conditions. Secondary objectives: - to investigate the effect of gender on the bioavailability of DF 2156Y and its metabolites (DF 2108Y and DF 2227Y) after single dose administration of 400 mg of ladarixin to healthy male and female volunteers - to evaluate safety and tolerability of a single dose administration of ladarixin 400 mg to healthy male and female volunteers.
Primary objective: •To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adult male and female volunteers. Secondary Objectives: - To determine the pharmacokinetics parameters of DF2755A - To establish a dose concentration-response relationship over a wide range of doses in order to select a narrower range of dose and dosing regimen to be subsequently studied in patients after single administration - To evaluate the effect of ascending single doses on the pharmacodynamics parameters - To compare metabolites pathway in Human with the one observed in animals Please note that the study has been closed after Part A (single ascending doses), so all the objectives were revised accordingly.
Part A The primary objective of this study is to determine the single dose pharmacokinetics (PK) of ketoprofen lysine salt combined with gabapentin (KLS-GABA [80 mg-34 mg]) compared to KLS alone (80 mg) in healthy male subjects. The secondary objective of this study is: • To determine the safety and tolerability of a single oral dose of KLS-GABA (80 mg-34 mg) compared to KLS alone (80 mg) in healthy male subjects. Part B The primary objective of this study is to determine the pharmacodynamic (PD) effects of KLS-GABA in the Intradermal (ID) capsaicin model in healthy male subjects. The secondary objectives of this study are: - To further investigate the safety, tolerability, and PK of single oral doses of KLS-GABA and KLS alone. - To investigate the possible relationship between plasma levels of drug and efficacy in pain reduction.
This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.
The current study sought to evaluate an intervention to promote healthy couple relationships and economic stability and mobility for low-income couples living in Northern Virginia (VA) and Montgomery and Prince George's Counties (MD). The approach proposed integrated two components:(1) a 20-hour evidence-informed couple group workshop called TOGETHER that integrates relationship and financial education, followed by an optional three-hour booster session three months after TOGETHER workshop and (2) case management (assessment of participant needs, development of Individual and Couple Development Plan(ICDP), referrals for social and mental health services, and referrals and coordination with job and career enhancement services, linking and coordination of all services as needed). The 20-hour workshop was offered in 8 sessions facilitated by couple and financial experts. The effectiveness of the program was evaluated through a randomized control trial in which couples were randomly assigned to a control group (n=147) or an intervention group (n=145). The control group received no intervention but a three-hour financial workshop after the last assessment was completed whereas the intervention couples participated in the 20-hour interventions and received case management. An independent local evaluator(AVAR, Consulting) participated in the design, implementation, and most of the data analysis. Participants had to be at least 18 years-old, living together for at least a year, and had no severe domestic violence issues, or untreated substance abuse or severe psychiatric disorders. If both partners were retired, couples were excluded from participation. Couples participated in an intake and enrollment meeting and were randomly assigned by a computer generated system to either the intervention or control group. Couples in both groups completed three sets of self-report measures: (1)Pre-test in first workshop session or at intake for control couples, (2)post-test in the last workshop session, or 8 weeks after the pre-test for control couples, and (3)follow-up six months after the post-test. After the six-month follow-up assessment, participation in the program was concluded. The study was largely funded by a Healthy Marriage and Responsible Fatherhood grant awarded by the Administration of Children and Families.
The aim of this study is to evaluate the intramuscular nominal thigh injection performance and the low threshold strength thigh injection (by evaluating 2 low threshold : upper limit and lower limit). All participants will receive an intramuscular nominal thigh injection, and half of the participants will receive an intramuscular low threshold (upper limit) strength thigh injection, while the other half will receive an intramuscular low threshold (lower limit) strength thigh injection.
Polycystic ovarian syndrome (PCOS) is most common endocrinologic disease in women of reproductive age with incidence of 6.6 ~ 8%. About fifty percent of the patients with PCOS manifest subfertility and significant proportion of these woman need assisted reproductive technology (ART). These patients are very sensitive to gonadotropins during conventional in vitro fertilization (IVF) and the risk of ovarian hyperstimulation syndrome (OHSS) is high. In vitro maturation (IVM) is an emerging alternative option to conventional IVF for minimizing the risk of OHSS in patients with PCOS. Until now, several studies has been reported the favorable outcomes of oocyte maturation rate, fertilization rate, clinical pregnancy rate, and live birth rate during IVM procedure. However, these results were from retrospective or observational study and there was no suitable randomized controlled trial (RCT). Therefore, this prospective RCT is aimed to compare and analyze the clinical outcomes between IVM and minimal stimulation IVF in women with PCOS, assessing if IVM is recommendable clinical practice or not.
The aim of this study is to evaluate the performance of the ZENEO needle free device in subcutaneous functioning limits (low performance limit and high performance limit) and for intramuscular injections.