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Contemporary Clinical Trials Communications

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https://www.readbyqxmd.com/read/29075673/healthy-lifestyle-intervention-for-african-american-uterine-cancer-survivors-study-protocol
#1
Jessica Lynn Stewart, Gina B Besenyi, Lovoria B Williams, Victoria Burt, Judith C Anglin, Sharad A Ghamande, Steven Scott Coughlin
BACKGROUND: Cancer of the uterine corpus is the most common gynecologic malignancy and the fourth most common cancer in U.S. women. There is a racial disparity in the survival from endometrial cancer and this may be addressed by culturally-tailored lifestyle interventions to help African American (AA) endometrial cancer survivors lose weight or maintain a healthy weight. OBJECTIVE: The overall purpose of this pilot study is to develop and evaluate a culturally-tailored lifestyle intervention to help AA uterine cancer survivors reduce their risk of cancer recurrence and improve their quality of life through healthy eating, physical activity, and weight management...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29124236/implementation-recruitment-and-baseline-characteristics-a-randomized-trial-of-combined-treatments-for-smoking-cessation-and-weight-control
#2
Terry Bush, Jennifer Lovejoy, Harold Javitz, Stacey Mahuna, Alula Jimenez Torres, Ken Wassum, Brooke Magnusson, Cody Benedict, Bonnie Spring
Background: Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. Methods: This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29062975/a-placebo-controlled-bayesian-dose-finding-design-based-on-continuous-reassessment-method-with-application-to-stroke-research
#3
Chunyan Cai, Mohammad H Rahbar, Md Monir Hossain, Ying Yuan, Nicole R Gonzales
Traditional dose-finding designs do not require assignment of patients to a control group. Motivated by SHRINC (Safety of Pioglitazone for hematoma resolution in intracerebral hemorrhage), we developed a placebo-controlled dose-finding study to identify the maximum tolerated dose for pioglitazone in stroke patients with spontaneous intracerebral hemorrhage. We designed an extension of the continuous reassessment method that allowed to incorporate information from the control group (i.e., the standard of care), and utilized it to determine the maximum tolerated dose in the SHRINC trial...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28798964/design-of-phase-ii-non-inferiority-trials
#4
Sin-Ho Jung
With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial...
September 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29082335/atrial-fibrillation-trial-to-evaluate-real-world-procedures-for-their-utility-in-helping-to-lower-stroke-events-after-pulse-study-protocol-for-a-randomized-controlled-trial
#5
Tsung-Ta Hsieh, Meng Lee, Wen-Yi Huang, Sung-Chun Tang, Sheng-Feng Sung, Kuo-Husan Chang, Jiann-Der Lee, Tsong-Hai Lee, Yung-Sung Huang, Jiann-Shing Jeng, Chang-Min Chung, Yi-Ling Wu, Bruce Ovbiagele
BACKGROUND: Enhancing detection of undiagnosed atrial fibrillation (AF) in hospitalized patients with a recent ischemic stroke is important because of the treatment implications; especially since presence of paroxysmal AF may not be picked up in a single 12-lead electrocardiogram (ECG) test. While several trials have shown improved detection of AF with prolonged ECG monitoring, this strategy is associated with relatively high cost, labor intensity, and patient inconvenience, thereby making it challenging to routinely implement in all hospitals...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29082334/development-and-pilot-testing-of-a-cognitive-behavioral-coping-skills-group-intervention-for-patients-with-chronic-hepatitis-c
#6
Donna M Evon, Carol E Golin, Rachel Ruffin, Michael W Fried
Psychosocial interventions for patients with chronic hepatitis C viral (HCV) infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV) undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1) formative work leading to intervention development; (2) preliminary study protocol; and (3) pilot feasibility testing of the intervention and study design...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29057368/intervention-development-for-the-indicated-prevention-of-depression-in-later-life-the-dil-protocol-in-goa-india
#7
Amit Dias, Fredric Azariah, Public Health, Alex Cohen, Stewart Anderson, Jennifer Morse, Pim Cuijpers, Miriam Sequeira, M A Psychology, Vithoba Gaude, Salvino Soares, Vikram Patel, Charles F Reynolds
Because depression is a major source of the global burden of illness- related disability, developing effective strategies for reducing its incidence is an important public health priority, especially in low-income countries, where resources for treating depression are scarce. We describe in this report an intervention development project, funded by the US National Institute of Mental Health, to address "indicated" prevention of depression in older adults attending rural and urban primary care clinics in Goa, India...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28944304/wearable-technology-to-reduce-sedentary-behavior-and-cvd-risk-in-older-adults-design-of-a-randomized-controlled-trial
#8
Lisa M Krehbiel, Andrew S Layne, Bhanuprasad Sandesara, Todd M Manini, Stephen D Anton, Thomas W Buford
Persons aged over 65 years account for over the vast majority of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Structured physical activity (i.e. exercise) is a well-documented method of decreasing CVD risk, but recent large-scale trials suggest that exercise alone is insufficient to reduce CVD events in high-risk populations of older adults. Thus adjuvant strategies appear necessary to reduce CVD risk...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28944303/resveratrol-and-exercise-to-treat-functional-limitations-in-late-life-design-of-a-randomized-controlled-trial
#9
Andrew S Layne, Lisa M Krehbiel, Robert T Mankowski, Stephen D Anton, Christiaan Leeuwenburgh, Marco Pahor, Bhanuprasad Sandesara, Samuel S Wu, Thomas W Buford
Skeletal muscle mitochondrial function declines with age and is a key factor in the maintenance of physical function among older adults. Research studies from animals and humans have consistently demonstrated that exercise improves skeletal muscle mitochondrial function in early and middle adulthood. However, mitochondrial adaptations to both acute and chronic exercise are attenuated in late life. Thus, there is an important need to identify adjuvant therapies capable of augmenting mitochondrial adaptations to exercise (e...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28752133/comparison-of-recruitment-and-retention-among-demographic-subgroups-in-a-large-diverse-population-study-of-diet
#10
Gwen L Alexander, Sujata Dixit-Joshi, Lawrence H Kushi, Laura A Coleman, Maria E Sundaram, Heather A Clancy, Michelle Groesbeck, Nancy A Potischman, Sharon I Kirkpatrick, Thea P Zimmerman, Stephanie M George, Amy F Subar, Frances E Thompson
OBJECTIVE: We examined the feasibility of conducting a longitudinal study of diet among diverse populations by comparing rates of response throughout recruitment and retention phases by demographic and other characteristics. METHODS: Using quota sampling, participants were recruited from 3 geographically and demographically diverse integrated health systems in the United States. Overall, 12,860 adults, ages 20-70, were invited to participate via mail. Participation first required accessing the study's website and later meeting eligibility criteria via telephone interview...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28736754/age-related-macular-degeneration-in-a-randomized-controlled-trial-of-low-dose-aspirin-rationale-and-study-design-of-the-aspree-amd-study
#11
Liubov Robman, Robyn Guymer, Robyn Woods, Stephanie Ward, Rory Wolfe, James Phung, Lauren Hodgson, Galina Makeyeva, Khin Zaw Aung, Tom Gilbert, Jessica Lockery, Y-Anh Le-Pham, Suzanne Orchard, Elsdon Storey, Walter Abhayaratna, Daniel Reid, Michael E Ernst, Mark Nelson, Christopher Reid, John McNeil
PURPOSE: Although aspirin therapy is used widely in older adults for prevention of cardiovascular disease, its impact on the incidence, progression and severity of age-related macular degeneration (AMD) is uncertain. The effect of low-dose aspirin on the course of AMD will be evaluated in this clinical trial. DESIGN: A sub-study of the 'ASPirin in Reducing Events in the Elderly' (ASPREE) trial, ASPREE-AMD is a 5-year follow-up double-blind, placebo-controlled, randomized trial of the effect of 100 mg daily aspirin on the course of AMD in 5000 subjects aged 70 years or older, with normal cognitive function and without cardiovascular disease at baseline...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28670629/statistical-analysis-plan-for-stage-1-embarc-establishing-moderators-and-biosignatures-of-antidepressant-response-for-clinical-care-study
#12
Eva Petkova, R Todd Ogden, Thaddeus Tarpey, Adam Ciarleglio, Bei Jiang, Zhe Su, Thomas Carmody, Philip Adams, Helena C Kraemer, Bruce D Grannemann, Maria A Oquendo, Ramin Parsey, Myrna Weissman, Patrick J McGrath, Maurizio Fava, Madhukar H Trivedi
Antidepressant medications are commonly used to treat depression, but only about 30% of patients reach remission with any single first-step antidepressant. If the first-step treatment fails, response and remission rates at subsequent steps are even more limited. The literature on biomarkers for treatment response is largely based on secondary analyses of studies designed to answer primary questions of efficacy, rather than on a planned systematic evaluation of biomarkers for treatment decision. The lack of evidence-based knowledge to guide treatment decisions for patients with depression has lead to the recognition that specially designed studies with the primary objective being to discover biosignatures for optimizing treatment decisions are necessary...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28649668/metabolic-costs-of-daily-activity-in-older-adults-chores-xl-study-design-and-methods
#13
Duane B Corbett, Amal A Wanigatunga, Vincenzo Valiani, Eileen M Handberg, Thomas W Buford, Babette Brumback, Ramon Casanova, Christopher M Janelle, Todd M Manini
BACKGROUND: For over 20 years, normative data has guided the prescription of physical activity. This data has since been applied to research and used to plan interventions. While this data seemingly provides accurate estimates of the metabolic cost of daily activities in young adults, the accuracy of use among older adults is less clear. As such, a thorough evaluation of the metabolic cost of daily activities in community dwelling adults across the lifespan is needed. METHODS: The Metabolic Costs of Daily Activity in Older Adults Study is a cross-sectional study designed to compare the metabolic cost of daily activities in 250 community dwelling adults across the lifespan...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28626811/the-enrich-study-to-evaluate-the-effectiveness-of-a-combination-intervention-package-to-improve-isoniazid-preventive-therapy-initiation-adherence-and-completion-among-people-living-with-hiv-in-ethiopia-rationale-and-design-of-a-mixed-methods-cluster-randomized
#14
Andrea A Howard, Yael Hirsch-Moverman, Suzue Saito, Tsigereda Gadisa, Amrita Daftary, Zenebe Melaku
BACKGROUND: Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. OBJECTIVE: The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. DESIGN: Ten health centers were randomized to receive the CIP or standard of care...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28508087/the-vitamin-d-for-enhancing-the-immune-system-in-cystic-fibrosis-disc-trial-rationale-and-design-of-a-multi-center-double-blind-placebo-controlled-trial-of-high-dose-bolus-administration-of-vitamin-d3-during-acute-pulmonary-exacerbation-of-cystic-fibrosis
#15
Vin Tangpricha, Ellen M Smith, Jose Binongo, Suzanne E Judd, Thomas R Ziegler, Seth Walker, Rabindra Tirouvanziam, Susu M Zughaier, Moon Jeong Lee, Supavit Chesdachai, Wendy A Hermes, James F Chmiel, Amit Gaggar, Ruth E Grossmann, Patricia M Joseph, Jessica A Alvarez
Vitamin D deficiency is highly prevalent in children and adults with cystic fibrosis (CF). Recent studies have found an association between vitamin D status and risk of pulmonary exacerbations in children and adults with CF. The ongoing Vitamin D for enhancing the Immune System in Cystic fibrosis (DISC) study is a multi-center, double-blind, randomized, placebo-controlled trial that will test the hypothesis of whether high dose vitamin D given as a single oral bolus of 250,000 IU to adults with CF during a pulmonary exacerbation followed by a maintenance dose of vitamin D will improve time to next pulmonary exacerbation and re-hospitalization, improve survival and lung function compared to placebo and reduce the rates of pulmonary exacerbation,...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28685168/recruitment-challenges-and-enrollment-observations-from-a-community-based-intervention-mothers-in-motion-for-low-income-overweight-and-obese-women
#16
Mei-Wei Chang, Susan Nitzke, Roger Brown, M Jean Brancheau Egan, Christopher M Bendekgey, Diana Buist
BACKGROUND: Mothers In Motion (MIM), a randomized controlled trial, aimed to help young, low-income overweight and obese mothers prevent weight gain by promoting stress management, healthy eating, and physical activity. This paper describes MIM recruitment challenges and reports demographic characteristics affecting enrollment. METHODS: Participants who were African American or Non-Hispanic White were recruited from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in Michigan...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28424796/external-data-required-timely-response-by-the-trial-steering-data-monitoring-committee-for-the-naloxone-investigation-n-alive-pilot-trial
#17
Sheila M Bird, John Strang, Deborah Ashby, John Podmore, J Roy Robertson, Sarah Welch, Angela M Meade, Mahesh K B Parmar
The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics Committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-Data Monitoring Committee (TS-DMC) on N-ALIVE's own interim data, together with those on naloxone-on-release (NOR) from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28424795/an-open-label-cluster-randomised-trial-to-evaluate-the-effectiveness-of-a-counselling-intervention-on-linkage-to-care-among-hiv-infected-patients-in-uganda-study-design
#18
Eugene Ruzagira, Kathy Baisley, Anatoli Kamali, Heiner Grosskurth
INTRODUCTION: Home-based HIV counselling & testing (HBHCT) is highly acceptable and has the potential to increase HIV testing uptake in sub-Saharan Africa. However, data are lacking on strategies that can effectively link HIV-positive individuals identified through HBHCT to care. This trial was designed to assess the effectiveness of two brief home-based counselling sessions on linkage to care, provided subsequent to referral for care among HIV-positive patients identified through HBHCT in a rural community in Masaka district, Uganda...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28424794/study-design-and-baseline-results-of-an-open-label-cluster-randomized-community-intervention-trial-to-assess-the-effectiveness-of-a-modified-mass-deworming-program-in-reducing-hookworm-infection-in-a-tribal-population-in-southern-india
#19
Rajiv Sarkar, Anuradha Rose, Venkata R Mohan, Sitara S R Ajjampur, Vasanthakumar Veluswamy, Rajan Srinivasan, Jayaprakash Muliyil, Vedantam Rajshekhar, Kuryan George, Vinohar Balraj, Nicholas C Grassly, Roy M Anderson, Simon J Brooker, Gagandeep Kang
INTRODUCTION: Hookworm infection is a leading cause of iron deficiency anemia and malnutrition in resource-poor settings. Periodic mass deworming with anthelminthic drugs remains the cornerstone of hookworm control efforts worldwide. Reinfection following treatment occurs, reflecting the human host's inability to acquire immunity following exposure to an untreated reservoir of infection. This cluster randomized trial will evaluate the effectiveness of a modified, population-based, mass deworming strategy in reducing hookworm infection in an endemic southern Indian population...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28378019/a-successful-approach-to-minimizing-attrition-in-racial-ethnic-minority-low-income-populations
#20
Glenn Flores, Alberto Portillo, Hua Lin, Candy Walker, Marco Fierro, Monica Henry, Kenneth Massey
BACKGROUND: Recruiting and retaining minority participants in clinical trials continue to be major challenges. Although multiple studies document lower minority trial enrollment, much less is known about effective minority retention strategies. Our objectives were to evaluate an innovative approach to high RCT retention of minority children, and identify child/caregiver characteristics predicting attrition. METHODS: The Kids' HELP trial examined the effects of Parent Mentors on insuring uninsured minority children...
March 2017: Contemporary Clinical Trials Communications
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