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Contemporary Clinical Trials

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https://www.readbyqxmd.com/read/29129704/wearable-activity-monitors-in-oncology-trials-current-use-of-an-emerging-technology
#1
REVIEW
Gillian Gresham, Jennifer Schrack, Louise M Gresham, Arvind M Shinde, Andrew E Hendifar, Richard Tuli, B J Rimel, Robert Figlin, Curtis L Meinert, Steven Piantadosi
BACKGROUND: Physical activity is an important outcome in oncology trials. Physical activity is commonly assessed using self-reported questionnaires, which are limited by recall and response biases. Recent advancements in wearable technology have provided oncologists with new opportunities to obtain real-time, objective physical activity data. The purpose of this review was to describe current uses of wearable activity monitors in oncology trials. METHODS: We searched Pubmed, Embase, and the Cochrane Central Register of Controlled Trials for oncology trials involving wearable activity monitors published between 2005 and 2016...
November 9, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29128651/design-and-rationale-of-the-medical-students-learning-weight-management-counseling-skills-msweight-group-randomized-controlled-trial
#2
Judith K Ockene, Karen M Ashe, Rashelle B Hayes, Linda C Churchill, Sybil L Crawford, Alan C Geller, Denise Jolicoeur, Barbara C Olendzki, Maria Theresa Basco, Jyothi A Pendharkar, Kristi J Ferguson, Thomas P Guck, Katherine L Margo, Catherine A Okuliar, Monica A Shaw, Taraneh Soleymani, Diane D Stadler, Sarita S Warrier, Lori Pbert
Physicians have an important role addressing the obesity epidemic. Lack of adequate teaching to provide weight management counseling (WMC) is cited as a reason for limited treatment. National guidelines have not been translated into an evidence-supported, competency-based curriculum in medical schools. Weight Management Counseling in Medical Schools: A Randomized Controlled Trial (MSWeight) is designed to determine if a multi-modal theoretically-guided WMC educational intervention improves observed counseling skills and secondarily improve perceived skills and self-efficacy among medical students compared to traditional education (TE)...
November 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29128650/parent-and-child-care-provider-partnerships-protocol-for-the-healthy-me-healthy-we-hmhw-cluster-randomized-control-trial
#3
Heidi Hennink-Kaminski, Amber E Vaughn, Derek Hales, Reneé H Moore, Courtney T Luecking, Dianne S Ward
BACKGROUND: Formation of diet and physical activity habits begins during early childhood. However, many preschool-aged children in the United States do not achieve recommendations for a nutritious diet or active lifestyle. Two important spheres of influence, home and child care, could ensure that children receive consistent health messages. Innovative approaches that engage both parents and child care providers in a substantial way are needed. Social marketing, a promising approach for health promotion targeting children, uses principles that recognize the need to engage multiple stakeholders and to emphasize benefits and overcome barriers associated with behavior change...
November 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29128649/design-of-a-randomized-controlled-trial-examining-the-efficacy-and-biological-mechanisms-of-web-prolonged-exposure-and-present-centered-therapy-for-ptsd-among-active-duty-military-personnel-and-veterans
#4
Carmen P McLean, Sheila A M Rauch, Edna B Foa, Rebecca K Sripada, Hallie S Tannahill, Jim Mintz, Jeffrey Yarvis, Stacey Young-McCaughan, Katherine A Dondanville, Brittany N Hall-Clark, Brooke A Fina, Terence M Keane, Alan L Peterson
Improved accessibility of effective and efficient evidence-based treatments (EBTs) for military personnel suffering with posttraumatic stress disorder (PTSD) is an urgent need to meet the growing demand for timely care. In addition, a better understanding of the mechanism of action of behavioral therapy can inform the delivery of care to meet accessibility demands. Effective EBTs for PTSD are available, but logistical and stigma-related barriers to accessing behavioral healthcare can deter military personnel from receiving these treatments...
November 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29128648/a-hypertension-emergency-department-intervention-aimed-at-decreasing-disparities-design-of-a-randomized-clinical-trial
#5
Heather M Prendergast, Marina Del Rios, Renee Petzel-Gimbar, Daniel Garside, Sara Heinert, Sandra Escobar-Schulz, Pavitra Kotini-Shah, Michael Brown, Jinsong Chen, Joseph Colla, Marian Fitzgibbon, Ramon A Durazo-Arvizu, Martha Daviglus
Effective interventions to identify and treat uncontrolled hypertension (HTN), particularly in underrepresented populations that use the emergency department (ED) for primary care, are critically needed. Uncontrolled HTN contributes significantly to cardiovascular morbidity and mortality and is more frequently encountered among patients presenting to the ED as compared to the primary care setting. EDs serve as the point of entry into the health care system for high-risk patient populations, including minority and low-income patients...
November 8, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29113956/rationale-and-design-of-the-home-trial-a-pragmatic-randomized-controlled-trial-of-home-based-human-papillomavirus-hpv-self-sampling-for-increasing-cervical-cancer-screening-uptake-and-effectiveness-in-a-u-s-healthcare-system
#6
Rachel L Winer, Jasmin A Tiro, Diana L Miglioretti, Chris Thayer, Tara Beatty, John Lin, Hongyuan Gao, Kilian Kimbel, Diana S M Buist
Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥3...
November 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29113955/treatment-of-fatigue-with-methylphenidate-modafinil-and-amantadine-in-multiple-sclerosis-triumphant-ms-study-design-for-a-pragmatic-randomized-double-blind-crossover-clinical-trial
#7
Bardia Nourbakhsh, Nisha Revirajan, Emmanuelle Waubant
BACKGROUND: Fatigue is the most common symptom of multiple sclerosis (MS). Amantadine, modafinil and amphetamine-like stimulants are commonly used in clinical practice for treatment of fatigue; however, the evidence supporting their effectiveness is sparse and conflicting. OBJECTIVE: To describe the design of a trial study funded by Patient-Centered Outcome Research Institute (PCORI) that will compare the efficacy of commonly used fatigue medications in patients with MS...
November 4, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29108869/the-cadmus-trial-multi-parametric-ultrasound-targeted-biopsies-compared-to-multi-parametric-mri-targeted-biopsies-in-the-diagnosis-of-clinically-significant-prostate-cancer
#8
Alistair Grey, Rebecca Scott, Susan Charman, Jan van der Meulen, Peter Frinking, Peter Acher, Sidath Liyanage, Sanjeev Madaan, Gabriel Constantinescu, Bina Shah, Chris Brew Graves, Alex Freeman, Charles Jameson, Navin Ramachandran, Mark Emberton, Manit Arya, Hashim U Ahmed
OBJECTIVE: To compare the proportion of clinically significant prostate cancers (PCa) found in lesions detected by multiparametric MRI (mpMRI) with that found in lesions detected by multiparametric ultrasound (mpUSS), in men at risk. PATIENTS AND METHODS: CADMUS (Cancer Detection by Multiparametric Ultrasound of the prostate) is a prospective, multi-centre paired cohort diagnostic utility study with built-in randomisation of order of biopsies. The trial is registered ISRCTN38541912...
November 3, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29104118/clinical-trial-conduct-in-special-populations-and-developing-regions-an-overview-of-the-dove-study-in-pediatric-patients-with-sickle-cell-disease
#9
Stephen G Reams, Linda Messana, Patricia B Brown, Kevin Nanry, Alexandria E Gunnell
Clinical trials conducted in unique patient populations or individuals with rare diseases are typically hampered by limitations in availability of qualified patients, requiring sponsors to broaden their global outreach to achieve enrollment. Engaging clinical study centers in developing regions may offer access to a substantially larger patient pool. However, they provide a unique set of challenges based on local cultures and requirements. The DOVE study (Determining effects Of platelet inhibition on Vaso-occlusive Events) was a clinical trial of prasugrel hydrochloride (prasugrel) in pediatric patients (aged 2 to <18years) with sickle cell anemia...
November 2, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29101042/magnitude-and-pattern-of-placebo-response-in-clinical-trials-of-antiepileptic-medications-data-from-the-food-and-drug-administration-1996-2016
#10
Arif Khan, Kaysee Fahl Mar, Joshua Schilling, Walter A Brown
This study aimed to replicate and extend the findings of previous investigations looking at treatment responses in antiepileptic clinical trials over time and to examine the effects of subject age and duration of treatment. To address the potential biases of published literature, we examined the reported data from 14 investigational antiepileptic drugs (AEDs) (34 trials, 59 treatment arms, 10,783 patients) reviewed and approved by the US FDA (1996-2016). For each treatment arm, we recorded drug and placebo response (percent reduction in seizure frequency), calculated effect sizes, and examined these measures over time...
October 31, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29097299/the-study-of-neurocognitive-outcomes-radiological-and-retinal-effects-of-aspirin-in-sleep-apnoea-rationale-and-methodology-of-the-snore-asa-study
#11
Stephanie Alison Ward, Elsdon Storey, Robyn L Woods, Garun S Hamilton, Ryo Kawasaki, Andrew L Janke, Matthew T Naughton, Fergal J O'Donoghue, Rory Wolfe, Tien Y Wong, Christopher M Reid, Walter P Abhayaratna, Nigel Stocks, Ruth Trevaks, Sharyn Fitzgerald, Lauren A B Hodgson, Liubov Robman, Barbara Workman, John J McNeil
PURPOSE: Sleep disordered breathing (SDB) is highly prevalent in older adults. Increasing evidence links SDB to the risk of dementia, mediated via a number of pathways, some of which may be attenuated by low-dose aspirin. This study will evaluate, in a healthy older cohort, the prospective relationship between SDB and cognitive function, changes in retinal and cerebral microvasculature, and determine whether low-dose aspirin ameliorates the effects of SDB on these outcomes over 3years...
October 30, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29097298/study-design-and-methods-for-the-activity-and-technology-activate-trial
#12
Brigid M Lynch, Nga H Nguyen, Marina M Reeves, Melissa M Moore, Dori E Rosenberg, Michael J Wheeler, Terry Boyle, Jeff K Vallance, Christine M Friedenreich, Dallas R English
BACKGROUND: Physical activity is positively associated with survival and quality of life among breast cancer survivors. Despite these benefits, the majority of breast cancer survivors are insufficiently active. The potential health benefits of reducing sedentary behaviour (sitting time) in this population have not been extensively investigated. The ACTIVATE Trial will evaluate the efficacy of an intervention that combines wearable technology (the Garmin Vivofit2®) with traditional behavioural change approaches to increase physical activity and reduce sedentary behaviour performed by breast cancer survivors...
October 30, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29081351/integrating-biological-treatment-mechanisms-into-randomized-clinical-trials-design-of-progress-prolonged-exposure-and-sertraline-trial
#13
Sheila A M Rauch, Naomi M Simon, H Myra Kim, Ron Acierno, Anthony P King, Sonya B Norman, Margaret R Venners, Katherine Porter, K Luan Phan, Peter W Tuerk, Carolyn Allard, Israel Liberzon, Barbara O Rothbaum, Brian Martis, Murray B Stein, Charles W Hoge
Increased emphasis on mechanisms of treatment effectiveness, biomarker predictors, and objective indicators of treatment response has sparked interest in integrated, translational treatment outcomes trials. The PROlonGed ExpoSure and Sertraline Trial (PROGrESS) is one such randomized controlled trial (RCT) focused on a key question in clinical management of posttraumatic stress disorder (PTSD) - the comparative and combined effectiveness of medication and psychotherapy. PROGrESS employs a state of the art trial design to examine psychotherapy and medication effects across three conditions: 1) Prolonged Exposure (PE) plus pill placebo, 2) Sertraline (SERT) plus Enhanced Medication Management (EMM), and 3) Combined treatment (PE/SERT)...
October 29, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29107036/evaluation-of-an-integrated-treatment-for-active-duty-service-members-with-comorbid-posttraumatic-stress-disorder-and-major-depressive-disorder-study-protocol-for-a-randomized-controlled-trial
#14
Kristen H Walter, Lisa H Glassman, W Michael Hunt, Nicholas P Otis, Cynthia J Thomsen
Posttraumatic stress disorder (PTSD) commonly co-occurs with major depressive disorder (MDD) in both civilian and military/veteran populations. Existing, evidence-based PTSD treatments, such as cognitive processing therapy (CPT), often reduce symptoms of both PTSD and depression; however, findings related to the influence of comorbid MDD on PTSD treatment outcomes are mixed, and few studies use samples of individuals with both conditions. Behavioral activation (BA), an approach that relies on behavioral principles, is an effective treatment for depression...
October 26, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29079392/promoting-healthy-home-environments-and-lifestyles-in-families-with-preschool-children-homestyles-a-randomized-controlled-trial
#15
Carol Byrd-Bredbenner, Jennifer Martin-Biggers, Gayle Alleman Povis, John Worobey, Nobuko Hongu, Virginia Quick
The purpose of the HomeStyles randomized controlled trial was to determine the effect of participation in the HomeStyles intervention vs an attention control condition on the weight-related aspects of the home environment and lifestyle behavioral practices of families with preschool children. Parents of preschool children (n=489) were systematically randomized to experimental or attention control group after completing the baseline survey. Baseline and post surveys comprehensively assessed study outcomes using a socio-ecological approach incorporating valid, reliable intrapersonal (e...
October 24, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29079391/strategies-for-supporting-intervention-fidelity-in-the-rehabilitation-therapy-in-older-acute-heart-failure-patients-rehab-hf-trial
#16
Amy M Pastva, Pamela W Duncan, Gordon R Reeves, M Benjamin Nelson, David J Whellan, Christopher M O'Connor, Joel D Eggebeen, Leigh Ann Hewston, Karen M Taylor, Robert J Mentz, Paul B Rosenberg, Dalane W Kitzman
INTRODUCTION: Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older adults. Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial is a multi-site clinical trial to determine if physical rehabilitation intervention in older patients with ADHF improves physical function and reduces rehospitalizations. The REHAB-HF intervention aims to improve functional performance utilizing reproducible and progressive exercises that are individually tailored to the patient's physiological and physical capabilities...
October 24, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29066293/the-mental-activity-and-exercise-max-trial-effects-on-physical-function-and-quality-of-life-among-older-adults-with-cognitive-complaints
#17
Laura E Middleton, Maria I Ventura, Wendy Santos-Modesitt, Gina Poelke, Kristine Yaffe, Deborah E Barnes
BACKGROUND: Older adults with cognitive complaints are vulnerable to dementia, physical impairments, and poor quality of life. Exercise and mental activity may improve physical function and health-related quality of life (HRQOL) but combinations have not been investigated systematically. The Mental Activity and eXercise (MAX) trial found that mental activity plus exercise over 12weeks improved cognitive function (primary outcome) in sedentary older adults with cognitive complaints. OBJECTIVE: To investigate the effects of combinations of two mental activity and exercise programs on physical function and HRQOL (secondary outcomes)...
October 21, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29051047/ostomy-telehealth-for-cancer-survivors-design-of-the-ostomy-self-management-training-osmt-randomized-trial
#18
Virginia Sun, Elizabeth Ercolano, Ruth McCorkle, Maria Grant, Christopher S Wendel, Nancy J Tallman, Frank Passero, Sabreen Raza, Zuleyha Cidav, Michael Holcomb, Ronald S Weinstein, Mark C Hornbrook, Robert S Krouse
PURPOSE: An ostomy adversely affects health-related quality of life (HRQOL) in a diverse population of cancer survivors and their caregivers. Hit-or-miss ostomy care, nurse counseling, and community referral have been the primary modes of self-management education and support in the peri-operative setting. Few evidence-based, systematic ostomy self-management programs are available to ensure optimal post-operative care. This paper describes the study design of a telehealth-based Ostomy Self-management Training (OSMT) program for cancer survivors and their caregivers...
October 16, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29038069/study-protocol-and-rationale-for-a-randomized-double-blinded-crossover-trial-of-phentermine-topiramate-er-versus-placebo-to-treat-binge-eating-disorder-and-bulimia-nervosa
#19
Shebani Sethi Dalai, Sarah Adler, Thomas Najarian, Debra Lynn Safer
INTRODUCTION: Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss...
October 14, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29031492/comprehensive-vs-assisted-management-of-mood-and-pain-symptoms-cammps-trial-study-design-and-sample-characteristics
#20
Kurt Kroenke, Erica Evans, Sharon Weitlauf, Stephanie McCalley, Brian Porter, Tabeel Williams, Fitsum Baye, Spencer G Lourens, Marianne S Matthias, Matthew J Bair
BACKGROUND: Pain is the most common presenting somatic symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. They frequently co-occur, are under-treated, and result in substantial disability and reduced health-related quality of life. OBJECTIVES: The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs...
October 12, 2017: Contemporary Clinical Trials
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