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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/28735110/blinded-sample-size-recalculation-in-clinical-trials-incorporating-historical-data
#1
Katharina Hees, Meinhard Kieser
Recruiting sufficient patients within an acceptable time horizon is an issue for most clinical trials and is especially challenging in the field of rare diseases. It is therefore an attractive option to include historical data from previous (pilot) trials in the current study thus reducing the recruitment burden. In clinical trials with binary endpoint, the required sample size does not only depend on the type I error rate, the power, and the treatment group difference but additionally on the overall event rate...
July 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28735109/design-and-rationale-for-a-real-world-observational-cohort-of-patients-with-nonalcoholic-fatty-liver-disease-the-target-nash-study
#2
A Sidney Barritt, Norman Gitlin, Samuel Klein, Anna S Lok, Rohit Loomba, Laura Malahias, Margaret Powell, Miriam B Vos, L Michael Weiss, Kenneth Cusi, Brent A Neuschwander-Tetri, Arun Sanyal
Nonalcoholic fatty liver disease (NAFLD) is highly prevalent and can lead to cirrhosis, hepatocellular carcinoma, and end-stage liver disease. NAFLD comprises the spectrum from simple steatosis (nonalcoholic fatty liver, NAFL), to steatosis with inflammation (nonalcoholic steatohepatitis, NASH). Current primary therapy recommended for NAFLD is weight loss induced by lifestyle modification. The difficulty in achieving this has led to robust pharmacological therapy development. While new drugs may show efficacy in selected phase II/III clinical trial populations, their real-world effectiveness is unknown...
July 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28732758/effects-of-narrator-empathy-in-a-computer-delivered-brief-intervention-for-alcohol-use
#3
Jennifer D Ellis, Emily R Grekin, Jessica R Beatty, Lucy McGoron, Benjamin V LaLiberte, Damaris E Pop, Anthony P Kostecki, Steven J Ondersma
Computer-delivered, brief interventions (CDBIs) have been an increasingly popular way to treat alcohol use disorders; however, very few studies have examined which characteristics of CDBIs maximize intervention effectiveness. The literature has consistently demonstrated that therapist empathy is associated with reduced substance use in in-person therapy; however, it is unclear whether this principle applies to CDBIs. Therefore, the study aimed to examine whether the presence of an empathic narrator increased intentions to reduce heavy drinking in a CDBI...
July 18, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28732757/multimodal-exercise-training-in-multiple-sclerosis-a-randomized-controlled-trial-in-persons-with-substantial-mobility-disability
#4
Brian M Sandroff, Rachel E Bollaert, Lara A Pilutti, Melissa L Peterson, Tracy Baynard, Bo Fernhall, Edward McAuley, Robert W Motl
BACKGROUND: Mobility disability is a common, debilitating feature of multiple sclerosis (MS). Exercise training has been identified as an approach to improve MS-related mobility disability. However, exercise randomized controlled trials (RCTs) on mobility in MS have generally not selectively targeted those with the onset of irreversible mobility disability. OBJECTIVES: The current multi-site RCT compared the efficacy of 6-months of supervised, multimodal exercise training with an active control condition for improving mobility, gait, physical fitness, and cognitive outcomes in persons with substantial MS-related mobility disability...
July 18, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28716496/corrigendum-to-surrogacy-of-progression-free-survival-for-overall-survival-in-metastatic-breast-cancer-studies-meta-analyses-of-published-studies-contemp-clin-trials-53-2017-20-28
#5
Madan G Kundu, Suddhasatta Acharyya
No abstract text is available yet for this article.
July 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28713032/psychosocial-rehabilitation-after-war-trauma-with-adaptive-disclosure-design-and-rationale-of-a-comparative-efficacy-trial
#6
Julie D Yeterian, Danielle S Berke, Brett T Litz
BACKGROUND: Posttraumatic stress disorder (PTSD) from warzone exposure is associated with chronic and disabling social and occupational problems. However, functional impairment is rarely assessed or targeted directly in PTSD treatments, which instead focus on symptom reduction. Trauma-related contributors to diminished functioning, including guilt, shame, and anger resulting from morally compromising or loss-based war experiences, are also underemphasized. The goal of this clinical trial is to fill a substantial gap in the treatment of military-related PTSD by testing a modified Adaptive Disclosure (AD) therapy for war-related PTSD stemming from moral injury and traumatic loss focused on improving psychosocial functioning AD...
July 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28712767/corrigendum-to-the-starting-treatment-for-ethanol-in-primary-care-trials-step-trials-protocol-for-three-parallel-multi-site-stepped-care-effectiveness-studies-for-unhealthy-alcohol-use-in-hiv-positive-patients-contemp-clin-trials-52-2017-80-90
#7
E Jennifer Edelman, Stephen A Maisto, Nathan B Hansen, Christopher J Cutter, James Dziura, Lynn E Fiellin, Patrick G O'Connor, Roger Bedimo, Cynthia Gibert, Vincent C Marconi, David Rimland, Maria C Rodriguez-Barradas, Michael S Simberkoff, Amy C Justice, Kendall J Bryant, David A Fiellin
No abstract text is available yet for this article.
July 13, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28710053/stimulation-of-the-ovaries-in-women-with-breast-cancer-undergoing-fertility-preservation-alternative-versus-standard-stimulation-protocols-the-study-protocol-of-the-stim-trial
#8
T Dahhan, E M E Balkenende, C C M Beerendonk, K Fleischer, D Stoop, A M E Bos, C B Lambalk, R Schats, R J T van Golde, J Schipper, L A Louwe, A E P Cantineau, J M J Smeenk, J P de Bruin, N Reddy, Y Kopeika, F van der Veen, M van Wely, S C Linn, M Goddijn
BACKGROUND: Chemotherapy for breast cancer may have a negative impact on reproductive function due to gonadotoxicity. Fertility preservation via banking of oocytes or embryos after ovarian stimulation with FSH can increase the likelihood of a future live birth. It has been hypothesized that elevated serum estrogen levels during ovarian stimulation may induce breast tumour growth. This has led to the use of alternative stimulation protocols with addition of tamoxifen or letrozole. The effectiveness of these stimulation protocols in terms of oocyte yield is unknown...
July 11, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28710052/rationale-and-design-of-feeding-america-s-bravest-mediterranean-diet-based-intervention-to-change-firefighters-eating-habits-and-improve-cardiovascular-risk-profiles
#9
Mercedes Sotos-Prieto, Sean B Cash, Costas Christophi, Sara Folta, Steven Moffatt, Carolyn Muegge, Maria Korre, Dariush Mozaffarian, Stefanos N Kales
Among US firefighters, cardiovascular disease is the leading cause of on-duty death. Poor diet contributes to this burden, but effective strategies to encourage healthy eating in the fire service are not established. "Feeding America's Bravest" motivates firefighters and their families to modify their food culture and reduce cardiometabolic risk profiles by adopting Mediterranean diet principles. Feeding America's Bravest is a cluster-randomized, controlled trial within the 44 stations of the Indianapolis Fire Department, including about 1000 firefighters...
July 11, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28700892/healthy-eating-and-active-living-after-gestational-diabetes-mellitus-heald-gdm-rationale-design-and-proposed-evaluation-of-a-randomized-controlled-trial
#10
Steven T Johnson, Ana B Mladenovic, Nonsikelelo Mathe, Margie H Davenport, Sonia Butalia, Weiyu Qiu, Jeffrey A Johnson
BACKGROUND: Gestational diabetes mellitus (GDM) is a common complication in pregnancy and a significant risk factor for type 2 diabetes (T2D). Most women who have had GDM are not engaging in health behaviours known to reduce their risk for developing future T2D. The objective of this study is to evaluate the effectiveness of a lifestyle modification program targeting healthy eating and active living behaviours after a GDM pregnancy. METHOD: This trial will randomize 100 women to either a lifestyle modification program or a control condition...
July 9, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28694204/the-mind-body-wellness-in-supportive-housing-mi-wish-study-design-and-rationale-of-a-cluster-randomized-controlled-trial-of-tai-chi-in-senior-housing
#11
Peter M Wayne, Margaret M Gagnon, Eric A Macklin, Thomas G Travison, Bradley Manor, Margie Lachman, Cindy P Thomas, Lewis A Lipsitz
Supporting the health of growing numbers of frail older adults living in subsidized housing requires interventions that can combat frailty, improve residents' functional abilities, and reduce their health care costs. Tai Chi is an increasingly popular multimodal mind-body exercise that incorporates physical, cognitive, social, and meditative components in the same activity and offers a promising intervention for ameliorating many of the conditions that lead to poor health and excessive health care utilization...
July 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28689852/development-of-an-integrated-cognitive-behavioral-therapy-for-anxiety-and-opioid-use-disorder-study-protocol-and-methods
#12
R Kathryn McHugh, Victoria R Votaw, David H Barlow, Garrett M Fitzmaurice, Shelly F Greenfield, Roger D Weiss
Opioid use disorder is a highly disabling psychiatric disorder, and is associated with both significant functional disruption and risk for negative health outcomes such as infectious disease and fatal overdose. Even among those who receive evidence-based pharmacotherapy for opioid use disorder, many drop out of treatment or relapse, highlighting the importance of novel treatment strategies for this population. Over 60% of those with opioid use disorder also meet diagnostic criteria for an anxiety disorder; however, efficacious treatments for this common co-occurrence have not be established...
July 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28689056/patient-navigation-for-lung-cancer-screening-in-an-urban-safety-net-system-protocol-for-a-pragmatic-randomized-clinical-trial
#13
David E Gerber, Heidi A Hamann, Noel O Santini, Suhny Abbara, Hsienchang Chiu, Molly McGuire, Lisa Quirk, Hong Zhu, Simon J Craddock Lee
The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population...
July 5, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28687349/program-for-lung-cancer-screening-and-tobacco-cessation-study-protocol-of-a-sequential-multiple-assignment-randomized-trial
#14
Steven S Fu, Alexander J Rothman, David M Vock, Bruce Lindgren, Daniel Almirall, Abbie Begnaud, Anne Melzer, Kelsey Schertz, Susan Glaeser, Patrick Hammett, Anne M Joseph
No abstract text is available yet for this article.
July 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28687348/design-and-approach-of-the-living-organ-video-educated-donors-loved-program-to-promote-living-kidney-donation-in-african-americans
#15
John C Sieverdes, Matthew Price, Kenneth J Ruggiero, Prabhakar K Baliga, Kenneth D Chavin, Brenda Brunner-Jackson, Sachin Patel, Frank A Treiber
PURPOSE: To describe the rationale, methodology, design, and interventional approach of a mobile health education program designed for African Americans with end stage renal disease (ESRD) to increase knowledge and self-efficacy to approach others about their need for a living donor kidney transplant (LDKT). METHODS: The Living Organ Video Educated Donors (LOVED) program is a theory-guided iterative designed, mixed methods study incorporating three phases: 1) a formative evaluation using focus groups to develop program content and approach; 2) a 2-month proof of concept trial (n=27) to primarily investigate acceptability, tolerability and investigate increases of LDKT knowledge and self-efficacy; and 3) a 6-month, 2-arm, 60-person feasibility randomized control trial (RCT) to primarily investigate increases in LDKT knowledge and self-efficacy, and secondarily, to increases the number of living donor inquiries, medical evaluations, and LDKTs...
July 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28687347/hestat-study-protocol-for-a-phase-ii-iii-randomized-placebo-controlled-single-blind-study-to-evaluate-the-new-hemostatic-agent-tt-173-in-total-knee-arthroplasty
#16
Aránzazu Gonzalez-Osuna, Sebastián Videla, Esther Cánovas, Gerard Urrútia, Santiago Rojas, Ramón López, Jesús Murat, Xavier Aguilera
BACKGROUND: Several hemostatic treatments intended to reduce the bleeding associated to total knee arthroplasty have been investigated with varying degrees of success. TT-173 is a new topical agent based on recombinant tissue factor that activates the extrinsic pathway of coagulation. This trial aim is to evaluate the efficacy and safety of TT-173 in total knee arthroplasty. METHODS/DESIGN: This is a phase II/III, sequential, simple blind, randomized, multicenter, placebo controlled and parallel clinical trial that will recruit 189 evaluable patients...
July 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28684357/promotora-assisted-depression-and-self-care-management-among-predominantly-latinos-with-concurrent-chronic-illness-safety-net-care-system-clinical-trial-results
#17
Kathleen Ell, María P Aranda, Shinyi Wu, Hyunsung Oh, Pey-Jiuan Lee, Jeffrey Guterman
The study evaluated depression and self-care management among patients with diabetes and/or heart disease in a 12-month randomized trial conducted in Los Angeles County Department of Health Services (LAC-DHS) community clinics. We compared LAC-DHS clinic usual care (UC) versus A-Helping-Hand (AHH) intervention in which bilingual promotoras, hired and supervised by the research project, provided 6 weekly psychoeducational sessions followed by boosters. Of 1957 screened, 348 depressed patients (PHQ-9 score≥10) were enrolled, randomized to AHH (n=178) or UC (n=170) after baseline interview assessing mental health, treatment receipt, co-morbid illness, self-care management, and environmental stressors...
July 3, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28600161/a-problem-solving-intervention-for-cardiovascular-disease-risk-reduction-in-veterans-protocol-for-a-randomized-controlled-trial
#18
Jason A Nieuwsma, Laura O Wray, Corrine I Voils, Jennifer M Gierisch, Margaret Dundon, Cynthia J Coffman, George L Jackson, Rhonda Merwin, Christina Vair, Karen Juntilla, Courtney White-Clark, Amy S Jeffreys, Amy Harris, Michael Owings, Johnpatrick Marr, David Edelman
BACKGROUND: Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. METHODS: Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS)...
June 23, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28648969/a-randomized-controlled-trial-of-a-smoking-cessation-self-help-intervention-for-dual-users-of-tobacco-cigarettes-and-e-cigarettes-intervention-development-and-research-design
#19
Lauren R Meltzer, Vani N Simmons, Steven K Sutton, David J Drobes, Gwendolyn P Quinn, Cathy D Meade, Marina Unrod, Karen O Brandon, Paul T Harrell, Thomas Eissenberg, Christopher R Bullen, Thomas H Brandon
Electronic Nicotine Delivery Systems, also called electronic cigarettes or e-cigarettes, have been available for over a decade and use has been increasing dramatically. The primary reported reasons for use are to aid smoking cessation or reduction, yet a significant proportion appear to be long-term users of both products ("dual users"). Dual users may be motivated to quit smoking and might benefit from a behavioral intervention for smoking cessation. This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT)...
June 22, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28600160/family-based-obesity-prevention-for-infants-design-of-the-mothers-others-randomized-trial
#20
Heather M Wasser, Amanda L Thompson, Chirayath M Suchindran, Eric A Hodges, Barbara D Goldman, Eliana M Perrin, Myles S Faith, Cynthia M Bulik, M Jane Heinig, Margaret E Bentley
OBJECTIVE: Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the first two years of life. DESIGN, PARTICIPANTS, AND METHODS: The design is a two-group randomized controlled trial among 468 AA pregnant women in central North Carolina...
June 21, 2017: Contemporary Clinical Trials
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