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Risk Reduction clinical trials

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NCT ID: NCT01948661 Active, not recruiting - Risk Reduction Clinical Trials

Anthocyanin Extract and Phospholipid Curcumin in Colorectal Adenoma

MIRACOL
Start date: March 2014
Phase: N/A
Study type: Interventional

Colonic adenomatous polyps are pre cancer lesions and are used as intermediate markers for testing agents with potential cancer prevention. Meriva© is a bioavailable form of curcumin, a polyphenolic compound obtained from turmeric (Curcuma longa L.) endowed with anti-inflammatory, antioxidant and antitumor effects. In vivo data indicate that curcumin formulated with phosphatidylcholine furnishes higher blood levels of parent agent than natural curcumin. Mirtoselect©, an anthocyanin mixture from bilberry containing isolated cyanidin-3-glucoside (C3G), the most abundant anthocyanin in diet, prevents intestinal adenoma formation in the Apc(Min) mouse model. The investigators hypothesize that the combination of both agents will decrease the expression of proteins involved in colon tumorigenesis relative to placebo. The change of biomarker expression between pre-treatment biopsy and post-treatment endoscopic resection in the target adenoma and the normal rectal mucosa will be the response measures. The primary response measure is the change of immunohistochemical (IHC) expression of β-catenin in adenomatous tissue and normal rectal mucosa. Secondary response measures are the changes of IHC Nuclear Factor-Kβ (NFKβ), cell proliferation by Ki-67 Labeling Index and apoptosis by P53 in adenomatous and adjacent normal mucosa. The study design is a phase II, randomized, double blind, placebo controlled, window of opportunity trial of the combination of Mirtoselect 1 gr/day+Meriva 1 gr/day or placebo. Subjects with histological confirmation of colorectal adenomatous polyps >1 cm not suitable to immediate complete removal will be enrolled in a 4-week intervention trial before endoscopic polypectomy. The demonstration of a biological activity of the two agent combination may provide the rationale for a phase III trial aimed at reducing the risk of colon cancer in high risk subjects.

NCT ID: NCT01713868 Completed - Risk Reduction Clinical Trials

Social Media And Risk-reduction Training for Infant Care Practices (SMART)

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

The goal of this proposal is to address serious and ongoing challenges related to adherence to public health recommendations known to reduce the risk of SIDS. Adherence has reached a plateau at an unacceptably low level both in the overall US population and especially in Black infants leading to a halt in the decline in infant mortality and a widening in the racial disparity in infant mortality. The current proposal is a collaborative effort that will capitalize on the extensive experience of the investigators in studying barriers to adherence to safe sleep practices to develop two complementary, culturally competent, intervention strategies and to test the effectiveness of each strategy as well as both strategies in combination. Innovative aspects of the Social Media and Risk-reduction Training of Infant Care Practices (SMART) study include its: 1) unique collaboration of leaders in the field; 2) leveraging of the currently operational infant care practices study infrastructure and hospitals; 3) use of two complementary interventions with the potential for synergistic impact; 4) use of social marketing strategies;5) use of mobile technology (mHealth) to deliver messages; and 6) collaboration with community resources and expertise. The SMART study will have four arms in which 16 hospitals are randomly assigned to one of the following study groups: 1) Safe Sleep Nursery Education and Breastfeeding mHealth messaging; 2) Breastfeeding Nursery Education and Safe Sleep mHealth messaging; 3) Safe Sleep Nursery Education and Safe Sleep mHealth messaging; 4) Breastfeeding Nursery Education and Breastfeeding mHealth messaging. A total of 1600 mothers will be recruited (100/hospital), with 400 in each study group. The primary aim is to assess the effectiveness of the interventions aimed at promoting safe sleep practices compared with the breastfeeding control interventions. The secondary aim is to assess potential mediating factors that may explain the intervention effects on infant care practices and that may inform areas for future improved intervention approaches. With the successful completion of the SMART study, effectiveness data will have been provided for two interventions to improve adherence to safe sleep practices that are practical to disseminate nationally in multiple diverse settings.

NCT ID: NCT01666496 Completed - HIV Clinical Trials

An Interactive Game for HIV Prevention in Early Adolescents

Start date: January 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate, through a randomized clinical trial, the efficacy of an interactive video game the investigators are developing at reducing risk behaviors in at-risk teens.

NCT ID: NCT01416545 Completed - Risk Reduction Clinical Trials

Children Education and Cardiovascular Risk Reduction in Their Parents

CETICARP
Start date: January 2010
Phase: N/A
Study type: Interventional

This study aims to evaluate if a multidisciplinary educational program in primary cardiovascular prevention for children could improve the Framingham Score index of their parents after one year.

NCT ID: NCT01376895 Completed - Risk Reduction Clinical Trials

Project Power: An HIV Risk Reduction Intervention for Black Men Who Have Sex With Men and Women (BMSM/W)

Power
Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to develop and test a program to help Black men who have sex with men and women reduce their chances of getting or giving HIV infection to their sex partners. The program is designed to be delivered via the internet so that it would be available to more men. Men who agree to participate in the study will be assigned by chance to receive the POWER intervention or a similar program that is focused on general health called POWER-HEALTH. They will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. Participants will receive a small compensation for their time and effort.

NCT ID: NCT01204619 Completed - Risk Reduction Clinical Trials

Trial on Education And Clinical Outcomes for Home PD Patients (TEACH)

TEACH
Start date: December 2010
Phase: N/A
Study type: Interventional

Since the emergence of home peritoneal dialysis as an alternative to in-center hemodialysis for chronic renal replacement therapy in the late 1970s, the percentage of dialysis patients on PD has continued to decrease each year. There have been a growing concern and research on patient and technique survival of peritoneal dialysis versus hemodialysis to find influential factors for better clinical outcomes. Meanwhile, technique failure rates were significantly higher in small centers treating less than twenty five PD patients. And there was a result for better technique survival after the second year, among the patients trained at the BREC(Baxter Renal Education Center). Better technique survival in large centers can be assumed with not only their more experience with patient management but also their educational infrastructure compared to small-sized centers. Throughout our experiences in the last 30 years, we have recognized that a major element of PD program is patient training, however few data are available in terms of the relationship between PD training and treatment outcome and mostly are retrospective and non-randomized. Moreover, the technique survival and patient survival were analyzed with no significant difference. From the insight, we decided to study prospectively to evaluate the efficacy of well-structured education program in terms of various patient outcomes in incident patients on PD.

NCT ID: NCT00797654 Completed - Risk Reduction Clinical Trials

HIV Prevention and Trauma Treatment in Men Who Have Sex With Men and Who Have a History of Sexual Abuse

Start date: August 2008
Phase: N/A
Study type: Interventional

This study will develop a therapy for men who have sex with men who also have a history of childhood sexual abuse to reduce behaviors that put them at a high risk of HIV infection.

NCT ID: NCT00128687 Completed - Clinical trials for Cardiovascular Diseases

Improving Coronary Prevention in a County Health System

Start date: April 2003
Phase: N/A
Study type: Interventional

To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program , a case management approach, can be effectively used to manage the risk of coronary artery disease.