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Contemporary Clinical Trials Communications
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Volume 78, Issue 3
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1. Publisher's Note
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2. Comparison of linear periodized and non-periodized combined training in health markers and physical fitness of adults with obesity: Clinical trial protocol
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Anne Ribeiro Streb, Robert Passos da Silva, Larissa dos Santos Leonel, Willen Remon Tozetto, ... Giovani Firpo Del Duca.
3. Impact of financial reimbursement on retention rates in military clinical trial research: A natural experiment within a multi-site randomized effectiveness trial with active duty service members
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Tác giả
Laura A. Novak, Bradley E. Belsher, Michael C. Freed, Phoebe K. McCutchan, ... Charles C. Engel.
4. Bridging the childhood epilepsy treatment gap in northern Nigeria (BRIDGE): Rationale and design of pre-clinical trial studies
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Tác giả
Muktar H. Aliyu, Aminu T. Abdullahi, Zubairu Iliyasu, Auwal S. Salihu, ... Jo Wilmshurst.
5. The efficacy and safety of probiotics intervention in attenuating cardiac remodeling following myocardial infraction: Literature review and study protocol for a randomized, double-blinded, placebo controlled trial
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Tác giả
Jalal Moludi, Mohammad Alizadeh, Mina Davari, Ali Golmohammadi, Vahid Maleki.
6. Culturally-tailored text-messaging intervention for smoking cessation in rural American Indian communities: Rationale, design, and methods
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Tác giả
Michael F. Orr, Ekaterina Burduli, Katherine A. Hirchak, Jo Ann Walsh Dotson, ... Sterling M. McPherson.
7. Sample size calculation for small sample single-arm trials for time-to-event data: Logrank test with normal approximation or test statistic based on exact chi-square distribution?
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Tác giả
Milind A. Phadnis.
8. Design and methods for the Ranger Resilience and Improved Performance on Phospholipid bound Omega-3's (RRIPP-3 study)
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Tác giả
Bernadette P. Marriott, Travis H. Turner, Joseph R. Hibbeln, Marcie Pregulman, ... Jacqueline S. Ross.
9. Do Social Cognitive Theory constructs explain response heterogeneity with a physical activity behavioral intervention in multiple sclerosis?
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Tác giả
Stephanie L. Silveira, Robert W. Motl.
10. A randomized controlled trial of exercise to prevent muscle mass and functional loss in elderly hemodialysis patients: Rationale, study design, and baseline sample
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Tác giả
Khin N. Chan, Yu Chen, Yiming Lit, Payam Massaband, ... Jonathan N. Myers.
11. Building community-clinical linkages to increase older adult physical activity: The PT-REFER trial protocol and participant baseline characteristics
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Tác giả
Miruna Petrescu-Prahova, Marlana Kohn, Brian Leroux, Lesley Steinman, ... Jeffrey R. Harris.
12. Preventing disability in older adults with mild cognitive impairment: A Strategy Training intervention study
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Tác giả
Juleen Rodakowski, Katlyn W. Golias, Charles F. Reynolds, Meryl A. Butters, ... Elizabeth R. Skidmore.
13. Comparing internal and external validation in the discovery of qualitative treatment-subgroup effects using two small clinical trials
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Tác giả
Maren K. Olsen, Karen M. Stechuchak, Karen E. Steinhauser.
14. Design of a randomized superiority trial of a brief couple treatment for PTSD
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Tác giả
Leslie A. Morland, Alexandra Macdonald, Kathleen M. Grubbs, Margaret-Anne Mackintosh, ... Shirley Glynn.
15. A phase 2 trial of N-Acetylcysteine in Biliary atresia after Kasai portoenterostomy
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Tác giả
Mary Elizabeth M. Tessier, Benjamin L. Shneider, Mary L. Brandt, Dana N. Cerminara, Sanjiv Harpavat.
16. Barriers to recruitment of children with cerebral palsy in a trial of home-based training
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Tác giả
L.W.M.E. Beckers, E.A.A. Rameckers, R.J.E.M. Smeets, J.J.W. van der Burg, ... Y.J.M. Janssen-Potten.
17. Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study
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Tác giả
Valerie Goldman, Amy Dushkin, Deborah J. Wexler, Yuchiao Chang, ... Linda M. Delahanty.
18. Feasibility and preliminary efficacy of Ai Chi aquatic exercise training in Hong Kong's older adults with risk of falling: Design and methodology of a randomized controlled trial
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Tác giả
Thomson W.L. Wong.
19. Impact of antiviral AV2 in the topical treatment of HPV-associated lesions of the cervix: Results of a phase III randomized placebo-controlled trial
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Tác giả
Alex Baleka Mutombo, Rahma Tozin, Hollande Kanyiki, Jean-Pierre Van Geertruyden, Yves Jacquemyn.
20. Trends in clinical trial investigator workforce and turnover: An analysis of the U.S. FDA 1572 BMIS database
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Tác giả
Christopher B. Fordyce, Matthew T. Roe, Christine Pierre, Terri Hinkley, ... James D. Topping.
21. Measurement of soft tissue drug concentrations in morbidly obese and non-obese patients – A prospective, parallel group, open-labeled, controlled, phase IV, single center clinical trial
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Tác giả
P. Simon, D. Petroff, C. Dorn, L. Ehmann, ... H. Wrigge.
22. Adaptive Signature Design- review of the biomarker guided adaptive phase –III controlled design
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Tác giả
Arinjita Bhattacharyya, Shesh N. Rai.
23. An investigation into the effects of acupuncture on radial pressure pulse waves in patients with low back pain: A protocol for a quasi-experimental study
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Tác giả
Hui-Ping Ng, Chin-Ming Huang, Wen-Chao Ho, Yu-Chen Lee.
24. Antidepressant discontinuation in treatment resistant depression
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Tác giả
Ziad A. Ali, Sharon Nuss, Rif S. El-Mallakh.
25. Evaluating the effects of design parameters on the performances of phase I trial designs
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Tác giả
Yaqian Zhu, Wei-Ting Hwang, Yimei Li.
26. Testing a variable-length Cognitive Processing Therapy intervention for posttraumatic stress disorder in active duty military: Design and methodology of a clinical trial
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Tác giả
Jennifer Schuster Wachen, Katherine A. Dondanville, Stacey Young-McCaughan, Jim Mintz, ... Patricia A. Resick.
27. Dose-response effects of high-intensity interval neuromuscular exercise training on weight loss, performance, health and quality of life in inactive obese adults: Study rationale, design and methods of the DoIT trial
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Tác giả
Alexios Batrakoulis, Ioannis G. Fatouros, Athanasios Chatzinikolaou, Dimitrios Draganidis, ... Athanasios Z. Jamurtas.
28. Participant recruitment into a community-based diabetes prevention trial in India: Learnings from the Kerala Diabetes Prevention Program
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Tác giả
Thirunavukkarasu Sathish, Zahra Aziz, Pilvikki Absetz, Kavumpurathu Raman Thankappan, ... Brian Oldenburg.
29. Incorporating an exercise rehabilitation programme for people with intermittent claudication into an established cardiac rehabilitation service: A protocol for a pilot study
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Tác giả
Edward Caldow, Andrew Findlow, Malcolm Granat, Mariyana Schoultz.
30. Investigating the safety and efficacy of nabilone for the treatment of agitation in patients with moderate-to-severe Alzheimer's disease: Study protocol for a cross-over randomized controlled trial
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Tác giả
Myuri T. Ruthirakuhan, Nathan Herrmann, Damien Gallagher, Ana C. Andreazza, ... Krista L. Lanctôt.
31. Behavioral economics implementation: Regret lottery improves mHealth patient study adherence
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Tác giả
S. Ali Husain, Keith M. Diaz, Joseph E. Schwartz, Faith E. Parsons, ... Ian M. Kronish.
32. Rationale and design of a pilot study to evaluate the acceptability and effectiveness of a revised protein sparing modified fast (rPSMF) for severe obesity in a pediatric tertiary care weight management clinic
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Tác giả
I.U. Eneli, R.P. Watowicz, J. Xu, A. Tindall, ... K.J. Pratt.
33. A pilot randomized trial of five financial incentive strategies to increase study enrollment and retention rates
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Tác giả
Dustin C. Krutsinger, Kuldeep N. Yadav, Elizabeth Cooney, Steven Brooks, ... Katherine R. Courtright.
34. Towards detecting cocaine use using smartwatches in the NIDA clinical trials network: Design, rationale, and methodology
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Tác giả
August F. Holtyn, Eugene Bosworth, Lisa A. Marsch, Bethany McLeman, ... Udi E. Ghitza.
35. Examining conscious motor processing and the effect of single-task, dual-task and analogy training on walking during rehabilitation by older adults at risk of falling in Hong Kong: Design and methodology of a randomized controlled trial
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Tác giả
Thomson W.L. Wong.
36. Orodispersible minitablets of enalapril for use in children with heart failure (LENA): Rationale and protocol for a multicentre pharmacokinetic bridging study and follow-up safety study
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Tác giả
Milica Bajcetic, Saskia N. de Wildt, Michiel Dalinghaus, Jörg Breitkreutz, ... Stephanie Läer.
37. Effects of biomarker diagnostic accuracy on biomarker-guided phase 2 trials
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Tác giả
Jay JH. Park, Ofir Harari, Louis Dron, Edward J. Mills, Kristian Thorlund.
38. Comparison of an ordinal endpoint to time-to-event, longitudinal, and binary endpoints for use in evaluating treatments for severe influenza requiring hospitalization
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Tác giả
Ross L. Peterson, David M. Vock, Abdel Babiker, John H. Powers, ... James D. Neaton.
39. Efficacy and safety of cytokines versus first-line sunitinib and second-line axitinib for patients with metastatic renal cell carcinoma (ESCAPE study): A study protocol for phase III randomized sequential open-label study
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Tác giả
Yoshifumi Kadono, Hiroyuki Konaka, Kouji Izumi, Satoshi Anai, ... Atsushiu Mizokami.
40. Patient preferences for using mobile technologies in clinical trials
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Tác giả
Brian Perry, Cindy Geoghegan, Li Lin, F. Hunter McGuire, ... Amy Corneli.
41. Protocol for evaluating a workplace intervention within the framework of consultations for suffering at work in French-speaking Switzerland
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Tác giả
Z. Mediouni, C. Barlet-Ghaleb, M. Zenoni, M. Rinaldo, ... P. Krief.
42. Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II: Design and methods of a randomized controlled trial among older veterans with chronic health conditions
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Tác giả
Gina M. McCaskill, Olivio J. Clay, Robert W. Motl, Karlene K. Ball.
43. Reporting of master protocols towards a standardized approach: A systematic review
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Tác giả
Ellie G. Siden, Jay JH. Park, Michael J. Zoratti, Louis Dron, ... Edward J. Mills.
44. The impact of central IRB's on informed consent readability and trial adherence in SPRINT
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Tác giả
Leonardo Tamariz, Mitscher Gajardo, Carolyn H. Still, Lisa H. Gren, ... Gabriel Contreras.
45. An alternative trial-level measure for evaluating failure-time surrogate endpoints based on prediction error
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Tác giả
Shaima Belhechmi, Stefan Michiels, Xavier Paoletti, Federico Rotolo.
46. Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease
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Tác giả
J. Nikles, J.D. O'Sullivan, G.K. Mitchell, S.S. Smith, ... A. Ritchie
47. Sensitivity of methods for analyzing continuous outcome from stratified cluster randomized trials – an empirical comparison study
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Tác giả
Sayem Borhan, Rizwana Mallick, Mershen Pillay, Harsha Kathard, Lehana Thabane.
48. Design for a cohort-randomized trial of an acceptance and commitment therapy-enhanced weight management and fitness program for Navy personnel
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Tác giả
Niloofar Afari, Jessica Gundy Cuneo, Matthew Herbert, Isabel Miller, ... Gordon Wisbach.
49. Recruitment challenges in stroke neurorecovery clinical trials
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Tác giả
Isadora Santos Ferreira, Camila Bonin Pinto, Faddi Ghassan Saleh Velez, Douglas Teixeira Leffa, ... Felipe Fregni.
50. Developing a model to predict accrual to cancer clinical trials: Data from an NCI designated cancer center
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Tác giả
Praveena Iruku, Martin Goros, Jonathan Gelfond, Jenny Chang, ... Virginia G. Kaklamani.
51. Ultrafiltration-profiled hemodialysis to reduce dialysis-related cardiovascular stress: Study protocol for a randomized controlled trial
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Tác giả
Matthew J. Tugman, Julia H. Narendra, Quefeng Li, Yueting Wang, ... Jennifer E. Flythe.
52. The use of text messaging for improving adherence to anti-diabetic regimen and glycaemic control in low-resource settings of South Africa: A study protocol for a randomised controlled trial
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Tác giả
Eyitayo Omolara Owolabi, Daniel Ter Goon.
53. Improving the promise of embedded pragmatic trials: Surmountable barriers encountered in an evaluation of home-based HPV self-sampling to increase cervical cancer screening in overdue women
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Tác giả
D.S.M. Buist, J.A. Tiro, C. Thayer, T. Beatty, ... R.L. Winer.
54. Picture This! Bringing joy into Focus and Developing Healthy Habits of Mind: Rationale, design, and implementation of a randomized control trial for young adults
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Tác giả
Laura G. McKee, Sara B. Algoe, Alyssa L. Faro, Jessica L. O'Leary, Catherine W. O'Neal.
55. Effect of Hemocare Syrup and Hemocare XT Tablets on Hemoglobin levels in iron deficiency anemia among women of reproductive age: A randomized, placebo controlled, open label trial
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Tác giả
Thangavel Mahalingam Vijayakumar, Ananthathandavan Priyadharshini, Sivaguru Paramesh Ahalya, Karunanidhi Santhana Lakshmi, ... Srivatsan Rama.
56. Knowledge and use of recruitment support tools among study coordinators at an academic medical center: The Novel Approaches to Recruitment Planning Study
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Tác giả
Ebony Scott, Bryan McComb, Howard Trachtman, Lois Mannon, ... Aisha Langford.
57. Evaluation of the Music Engagement Program for people with Alzheimer's disease and dementia: Study protocol for a pilot trial
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Tác giả
Amelia Gulliver, Georgia Pike, Michelle Banfield, Alyssa R. Morse, ... Susan West.
58. Rationale and design of a feasibility and acceptability RCT of romantic partner and support figure attendance during bariatric surgery visits
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Tác giả
Megan Ferriby, Keeley Pratt, Lorraine Wallace, Brian C. Focht, ... Bradley Needleman.
59. Efficacy of smoking cessation with varenicline plus counselling for e-cigarettes users (VAREVAPE): A protocol for a randomized controlled trial
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Tác giả
Pasquale Caponnetto, Marilena Maglia, Riccardo Polosa.
60. IodiNe Subtraction mapping in the diagnosis of Pulmonary chronIc thRomboEmbolic disease (INSPIRE): Rationale and methodology of a cross-sectional observational diagnostic study
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Tác giả
Yousef Shahin, Christopher Johns, Kavitasagary Karunasaagarar, David G. Kiely, Andy J. Swift.
61. Resources to assist in the transition to a single IRB model for multisite clinical trials
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Tác giả
Cynthia Hahn, Petra Kaufmann, Soo Bang, Sara Calvert.
62. Leveraging system sciences methods in clinical trial evaluation: An example concerning African American women diagnosed with breast cancer via the Patient Navigation in Medically Underserved Areas study
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Tác giả
Yamilé Molina, Aditya Khanna, Karriem S. Watson, Dana Villines, ... Elizabeth A. Calhoun.
63. A descriptive research: Exclusion from submitted clinical data package in the review process of new drug approval due to GCP violation in Japan
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Tác giả
Ryuta Asada, Kenichi Yoshimura, Kayo Hattori, Yujiro Nonaka, ... Shinobu Shimizu.
64. Design of the patient navigator to Reduce Readmissions (PArTNER) study: A pragmatic clinical effectiveness trial
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Tác giả
Valentin Prieto-Centurion, Sanjib Basu, Nina Bracken, Elizabeth Calhoun, ... Jerry A. Krishnan.
65. Non invAsive VentIlation for early General wArd respiraTory failurE NAVIGATE
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Tác giả
Luca Cabrini;.....
Nội dung
Pages 126-132
66. Multi pronged intervention to increase secondary student participation in school lunch Design and rationale
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Tác giả
Stephanie Machado;.....
Nội dung
Pages 133-139
67. A brief intervention to increase uptake and adherence of an online program for depression and anxiety
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Tác giả
Philip J. Batterham;.....
Nội dung
Pages 107-115
68. Intervention Comparative Effectiveness for Adult Cognitive Training ICE ACT Trial Rationale design and baseline characteristics
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Tác giả
Jong Sung Yoon;.....
Nội dung
Pages 76-87
69. Rationale and study design of the MyHEART study A young adult hypertension self management randomized controlled trial
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Tác giả
Heather M. Johnson;....
Nội dung
Pages 88-100
70. The Healthy Pregnancies Project Study protocol and baseline characteristics
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Tác giả
Christi A. Patten;....
Nội dung
Pages 116-125
71. An addiction based mobile health weight loss intervention protocol of a randomized controlled trial
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Tác giả
Alaina P. Vidmar; Sarah J. Salvy.
Nội dung
Pages 11-19