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NCT ID: NCT05901220 Completed - No Condition Clinical Trials

Joint School-Health Project of the Neapolitan Child

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05882942 Recruiting - No Condition Clinical Trials

Matcha Green Tea Effects at Rest and During Moderate-intensity Exercise in Females

Start date: March 3, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04854642 Completed - no Condition Clinical Trials

A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers

Start date: October 20, 2020
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT04803396 Completed - no Condition Clinical Trials

Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A

Start date: November 15, 2018
Phase: Phase 1
Study type: Interventional

Primary objective: •To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy adultmale 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 toselect a narrower range of dose and dosing regimen to be subsequently studied in patients aftersingle 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

NCT ID: NCT04802967 Completed - No Condition Clinical Trials

A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT04455295 Active, not recruiting - Clinical trials for Electroencephalography

Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation

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

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.

NCT ID: NCT04227405 Terminated - No Condition Clinical Trials

TOGETHER: A Couple's Model to Enhance Relationships and Economic Stability

Start date: July 12, 2016
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03225638 Not yet recruiting - No Condition Clinical Trials

Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03134482 Recruiting - No Condition Clinical Trials

Comparison of Clinical Outcomes Between IVM and Minimal Stimulation IVF in Patients With PCOS

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03044301 Completed - No Condition Clinical Trials

Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®)

Start date: March 2015
Phase: N/A
Study type: Interventional

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.