Read by QxMD icon Read

Contemporary Clinical Trials

Denise M Hynes, Michael Fischer, Linda A Schiffer, Rani Gallardo, Ifeanyi Beverly Chukwudozie, Anna Porter, Michael Berbaum, Jennifer Earheart, Marian L Fitzgibbon
INTRODUCTION: Using a quasi-experimental design, we implemented the Patient-Centered Medical Home for Kidney Disease (PCMH-KD), a comprehensive, multidisciplinary care team to improve quality of life and healthcare coordination for adult chronic hemodialysis (CHD) patients. This paper highlights our experience in the first two years of the study.We focus on the process dimensions of Reach, Adoption, and Implementation within the context of the RE-AIM framework. MATERIALS AND METHODS: We established a new PCMH-KD model at two outpatient dialysis centers...
October 18, 2016: Contemporary Clinical Trials
Maria I Ventura, Deborah E Barnes, Jessica M Ross, Kimberly E Lanni, Karen A Sigvardt, Elizabeth A Disbrow
Parkinson's disease (PD) is a progressive neurodegenerative disease associated with deficits in motor, cognitive, and emotion/quality of life (QOL) domains, yet most pharmacologic and behavioral interventions focus only on motor function. Our goal was to perform a pilot study of Dance for Parkinson's-a community-based program that is growing in popularity-in order to compare effect sizes across multiple outcomes and to inform selection of primary and secondary outcomes for a larger trial. Study participants were people with PD who self-enrolled in either Dance for Parkinson's classes (intervention group, N=8) or PD support groups (control group, N=7)...
October 17, 2016: Contemporary Clinical Trials
Angelo Alonzo, Scott Aaronson, Marom Bikson, Mustafa Husain, Sarah Lisanby, Donel Martin, Shawn M McClintock, William M McDonald, John O'Reardon, Zeinab Esmailpoor, Colleen Loo
Transcranial Direct Current Stimulation (tDCS) is a new, non-invasive neuromodulation approach for treating depression that has shown promising efficacy. The aim of this trial was to conduct the first international, multicentre randomised controlled trial of tDCS as a treatment for unipolar and bipolar depression. The study recruited 120 participants across 6 sites in the USA and Australia. Participants received active or sham tDCS (2.5mA, 20 sessions of 30min duration over 4weeks), followed by a 4-week open label active treatment phase and a 4-week taper phase...
October 15, 2016: Contemporary Clinical Trials
Ryan D McDonald, Babak Tofighi, Eugene Laska, Keith Goldfeld, Wanda Bonilla, Mara Flannery, Nadina Santana-Correa, Christopher W Johnson, Neil Leibowitz, John Rotrosen, Marc N Gourevitch, Joshua D Lee
No abstract text is available yet for this article.
October 13, 2016: Contemporary Clinical Trials
Robert P Schwartz, Sharon M Kelly, Shannon G Mitchell, Laura Dunlap, Gary A Zarkin, Anjalee Sharma, Kevin E O'Grady, Jerome H Jaffe
No abstract text is available yet for this article.
October 8, 2016: Contemporary Clinical Trials
Nooshin Razani, Michael A Kohn, Nancy M Wells, Doug Thompson, Hanna Hamilton Flores, George W Rutherford
BACKGROUND: Contact with nature improves human health; stress reduction is a mediating pathway. Stay Healthy in Nature Everyday (SHINE) is a stress reduction and health promotion intervention for low-income families at an urban Federally Qualified Health Center. We plan to evaluate two service-delivery models for SHINE and present here the intervention design and evaluation protocol. METHODS: Behavioral change theory and environmental education literature informed the intervention...
September 29, 2016: Contemporary Clinical Trials
Edward V Nunes, Joshua D Lee, Dominic Sisti, Andrea Segal, Arthur Caplan, Marc Fishman, Genie Bailey, Gregory Brigham, Patricia Novo, Sarah Farkas, John Rotrosen
We examine ethical challenges encountered in the design of an effectiveness trial (CTN-0051; X:BOT), comparing sublingual buprenorphine-naloxone (BUP-NX), an established treatment for opioid dependence, to the newer extended-release injectable naltrexone (XR-NTX). Ethical issues surrounded: 1) known poor effectiveness of one possible, commonly used treatment as usual control condition-detoxification followed by counseling without medication; 2) the role of patients' preferences for treatments, given that treatments were clinically approved and available to the population; 3) differences between the optimal "usual treatment" clinical settings for different treatments making it challenging to design a fair comparison; 4) vested interest groups favoring different treatments exerting potential influence on the design process; 5) potentially vulnerable populations of substance users and prisoners; 6) potential therapeutic misconception in the implementation of safety procedures; and 7) high cost of a large trial limiting questions that could be addressed...
September 28, 2016: Contemporary Clinical Trials
Ruth Schübel, Mirja E Graf, Johanna Nattenmüller, Diana Nabers, Disorn Sookthai, Laura F Gruner, Theron Johnson, Christopher L Schlett, Oyunbileg von Stackelberg, Romy Kirsten, Nina Habermann, Mario Kratz, Hans-Ulrich Kauczor, Cornelia M Ulrich, Rudolf Kaaks, Tilman Kühn
Mechanistic studies suggest benefits of intermittent calorie restriction (ICR) in chronic disease prevention that may exceed those of continuous calorie restriction (CCR), even at equal net calorie intake. Despite promising results from first trials, it remains largely unknown whether ICR-induced metabolic alterations reported from experimental studies can also be observed in humans, and whether ICR diets are practicable and effective in real life situations. Thus, we initiated the HELENA Trial to test the effects of ICR (eu-caloric diet on five days and very low energy intake on two days per week) on metabolic parameters and body composition over one year...
September 28, 2016: Contemporary Clinical Trials
Amanda Darekar, Martin Carlsson, Sheila Quinn, Fady Ntanios, Erin Mangan, Daniel Arumi, David Scholfield
The ability to set realistic expectations of treatment response in patients with overactive bladder (OAB) can have an impact on patient engagement and adherence to study medication. In order to help set treatment expectations for OAB, a Physician Predictive Tool has been developed based on predictive modelling. Models have been developed utilizing data from eight Phase 3 and 4 fesoterodine clinical trials and these models enable the prediction of individual treatment response in subjects with OAB, based on various baseline characteristics...
September 27, 2016: Contemporary Clinical Trials
Li-Tzy Wu, Jennifer McNeely, Geetha A Subramaniam, Gaurav Sharma, Paul VanVeldhuisen, Robert P Schwartz
No abstract text is available yet for this article.
September 22, 2016: Contemporary Clinical Trials
Caroline Hurley, Frances Shiely, Jessica Power, Mike Clarke, Joseph A Eustace, Evelyn Flanagan, Patricia M Kearney
INTRODUCTION: In November 2016, the Integrated Addendum to ICH-GCP E6 (R2) will advise trial sponsors to develop a risk-based approach to clinical trial monitoring. This new process is commonly known as risk based monitoring (RBM). To date, a variety of tools have been developed to guide RBM. However, a gold standard approach does not exist. This review aims to identify and examine RBM tools. METHODS: Review of published and grey literature using a detailed search-strategy and cross-checking of reference lists...
September 15, 2016: Contemporary Clinical Trials
David B Bekelman, Larry A Allen, Jamie Peterson, Brack Hattler, Edward P Havranek, Diane L Fairclough, Connor F McBryde, Paula M Meek
While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status...
September 12, 2016: Contemporary Clinical Trials
Xuezhou Mao, Ying Kuen Cheung
This paper addresses dose finding in clinical trials where individuals exhibit biologic characteristics that alter the toxicity risks of the individuals. In these situations, instead of determining a dose that works for every patient, the trial aims to identify a dosing algorithm that prescribes dose according to the patient's biomarker or pharmacokinetic expression. Specifically, we aim to dose patients around a pre-specified level of area under the curve of irinotecan concentration using the patients' baseline phenotypes that predict drug clearance...
August 31, 2016: Contemporary Clinical Trials
Anna Kline, Megan Chesin, Miriam Latorre, Rachael Miller, Lauren St Hill, Anton Shcherbakov, Arlene King, Barbara Stanley, Marc D Weiner, Alejandro Interian
BACKGROUND: Although suicide ranks 10th as a cause of death in the United States, and 1st among active military personnel, there are surprisingly few evidence-based therapies addressing suicidality, and development of new treatments is limited. This paper describes a clinical trial testing a novel therapy for reducing suicide risk in military veterans. The intervention, Mindfulness-Based Cognitive Therapy for Preventing Suicide Behavior (MBCT-S), is a 10-week group intervention adapted from an existing treatment for depression (Mindfulness-Based Cognitive Therapy - MBCT)...
September 2016: Contemporary Clinical Trials
Susan M Breitenstein, Michael Schoeny, Heather Risser, Tricia Johnson
INTRODUCTION: Up to 20% of children demonstrate behavior problems that interfere with relationship development and academic achievement. Parent participation in behavioral parent training programs has been shown to decrease child problem behaviors and promote positive parent-child relationships. However, attendance and parent involvement in face-to-face parent training remain low. Testing the implementation, efficacy, and cost of alternative delivery models is needed to (a) increase the reach and sustainability of parent training interventions and (b) address the barriers to parent participation and implementation of such programs, specifically in primary health care settings...
September 2016: Contemporary Clinical Trials
Michael B Saddekni, Kenneth G Saag, Tanja Dudenbostel, Suzanne Oparil, David A Calhoun, Sebastian E Sattui, Daniel I Feig, Paul Muntner, David T Redden, Phillip J Foster, Elizabeth J Rahn, Stephanie R Biggers, Peng Li, Angelo L Gaffo
BACKGROUND: The association between hyperuricemia and hypertension is controversial. Animal models, epidemiological data, and small clinical trials have favored a causative role for hyperuricemia in hypertension but more studies are necessary to elucidate putative mechanisms, population susceptibility, and potential for urate-lowering therapies (ULT) to decrease blood pressure (BP). PURPOSE: To describe the background and design of the Serum Urate Reduction to Prevent Hypertension (SURPHER) study...
September 2016: Contemporary Clinical Trials
Mark B Powers, Brooke Y Kauffman, Anne L Kleinsasser, Eunjung Lee-Furman, Jasper A J Smits, Michael J Zvolensky, David Rosenfield
Posttraumatic stress disorder (PTSD) is related to an increased risk of smoking cessation failure. In fact, the quit rate in smokers with PTSD (23.2%) is one of the lowest of all mental disorders. Features of PTSD that contribute to smokers' progression to nicotine dependence and cessation relapse include negative affect, fear, increased arousal, irritability, anger, distress intolerance, and anxiety sensitivity. Anxiety sensitivity is higher in people with PTSD than in any other anxiety disorder except for panic disorder...
September 2016: Contemporary Clinical Trials
Christina S Lee, Suzanne M Colby, Molly Magill, Joanna Almeida, Tonya Tavares, Damaris J Rohsenow
BACKGROUND: The NIH Strategic Plan prioritizes health disparities research for socially disadvantaged Hispanics, to reduce the disproportionate burden of alcohol-related negative consequences compared to other racial/ethnic groups. Cultural adaptation of evidence-based treatments, such as motivational interviewing (MI), can improve access and response to alcohol treatment. However, the lack of rigorous clinical trials designed to test the efficacy and theoretical underpinnings of cultural adaptation has made proof of concept difficult...
September 2016: Contemporary Clinical Trials
Lisa Jahns, James N Roemmich
In this manuscript, we present the protocol for a study that applies incentive sensitization theory to improve vegetable intake in overweight and obese adults. This 8-week, randomized, controlled, community-based feeding study with an 8-week follow-up seeks to use repeated exposure to amounts of vegetables recommended by federal guidance to increase the primary outcome of the relative reinforcing value of vegetables compared to a snack food. A community-based design is used to give participants autonomy in choosing their method of exposure...
September 2016: Contemporary Clinical Trials
Mallory G Cases, Andrew D Frugé, Jennifer F De Los Santos, Julie L Locher, Alan B Cantor, Kerry P Smith, Tony A Glover, Harvey J Cohen, Michael Daniel, Casey D Morrow, Douglas R Moellering, Wendy Demark-Wahnefried
BACKGROUND: Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these domains. METHODS: This report describes the methods and recruitment experiences from two randomized controlled feasibility trials that employ a waitlist-controlled design...
September 2016: Contemporary Clinical Trials
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"