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Filter by: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.
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.