Browsing by Subject "Randomized controlled trial"

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    Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth
    (2013-11-22) Hodges, James S; Michalowicz, Bryan S; hodge003@umn.edu; Hodges, James S.
    The OPT Study was a multi-center randomized, single-blind (examiners) controlled clinical trial testing whether mechanical periodontal therapy (scaling and planing) in pregnant women at risk for premature birth reduced the extent or severity of premature birth. OPT found that periodontal therapy does not reduce the number or timing of premature births. Data include birth outcomes (including gestational age, birthweight, presence of congenital anomalies, and 1 and 5 minute APGAR scores), baseline characteristics (including previous pregnancy outcomes), periodontal therapy and essential dental care delivered as part of the study, maternal conditions during pregnancy, and the following items for three visits between the end of the first trimester and delivery: clinical periodontal measurements (pocket depth, attachment loss, and bleeding on probing at 6 sites per tooth; site-specific data and several common person-level summaries), medications, dental plaque levels of 8 bacterial species, levels of serum antibodies for the same 8 bacterial species, and serum levels of 8 inflammatory markers or mediators. The OPT Study's Manual of Procedures (Version 1) is available as part of this package. Version changes during the course of the study were rare and affected very few data items (mostly the data describing study periodontal therapy). The OPT Study team published the main paper in 2006 in the New England Journal of Medicine and has published 8 secondary papers.
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    A Longitudinal Analysis of the Effects of the NYU Caregiver Intervention-Adult Child on Subjective Health
    (2020-11-10) Albers, Elizabeth, A
    Objective: The present study examined whether the NYU Caregiver Intervention for Adult Children (NYUCI-AC) influenced the subjective health of adult child family caregivers of persons with dementia. Methods: A randomized controlled trial, conducted between 2006 and 2012, compared outcomes among a psychosocial intervention group to usual care controls. One hundred and seven adult child caregivers of persons with dementia were included in the sample (n=54 assigned to the intervention group; n=53 assigned to the usual care control group). Participants were assessed up to eight times; every four months in the first year, then every six months afterwards. The current study focused on the effects of the NYUCI-AC on changes in self-rated health over the study period. Results: Growth curve models found that self-rated health among intervention group and control group caregivers did not differ over the study period. No effect of the intervention on self-rated health emerged over time after controlling for baseline differences in gender and satisfaction with social support. Conclusions: The NYUCI-AC is a multicomponent psychosocial intervention that provides counseling and support to adult child caregivers and did not alter subjective health over time.
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    Modeling Of The Interaction Between Colon And Colonoscope During A Colonoscopy
    (2018-05) He, Xuehuan
    One of the main complications in completing a colonoscopy is that the colonoscope causes patient pain during the procedure. To reduce patient pain, small-caliber (SC) colonoscopes have been developed. To evaluate the efficacy of SC colonoscopes in reducing patient pain with that of traditional standard colonoscope (SDC), several randomized control trials (RCTs) were conducted and showed varying results, with some showed benefits whereas others did not. Among these RCTs, patient characteristics, including gender, age, and region were varied and further assumed to be responsible for the varied results. However, the influence of patient characteristics on the efficacy of SC colonoscopes in terms of reducing patient pain is still unclear due to many unavoidable disturbing factors in RCTs, including endoscopists’ skills, bowel preparation methods, and other new beneficial features of colonoscopes (passive bending and high force transmission shaft). Therefore, to explore the influence of gender, age, and region of patients on the efficacy of SC colonoscopes in terms of reducing patient pain, a numerical model could overcome the limitations of RCTs and provide such insight is developed in our work. As a first step, the structural differences of the human colon with respect to gender, age, and region were analyzed and summarized, which further functions as the basis of the development of colon models and their boundary conditions. As a result, three normalized colon segments were selected and modelled, including rectosigmoid junction (RCJ), rectum-splenic flexure (RSF), and transverse-hepatic flexure (THF) models. The colonoscope was modelled as a thin and flexible cylinder with a hemisphere tip. Three different diameters were applied to colonoscope models, including 9.2mm for ultrathin colonoscope (UTC), 11.3mm for pediatric colonoscope (PDC), and 12.8mm for standard colonoscope (SDC). UTC and PDC were classified as SC colonoscopes. In the stage of insertion simulation, a comparison between implicit and explicit finite element solution method was conducted, and then an explicit solver ANSYS-LSDYNA was selected to simulate the insertion process of colonoscopes in colon models. An uni-axial tension test was carried out to provide the experimental data of a porcine colon, and then an optimization procedure with the use of ANSYS and Optislang programs was performed to provide the necessary parameters of the constitutive material model of the colonic tissue. By comparing colon deformation during the insertion simulation, patient pain induced by colonoscopes were further predicted. The model developed in this research serves as a starting point in understanding the efficacy of SC colonoscopes in reducing patient pain considering the effects of patient characteristics, including gender, age, and region. This model may also provide scientific guidelines for the selection of patient specified colonoscope