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Contemporary Clinical Trials

Yan Xue, Xianghong Qin, Liya Zhou, Sanren Lin, Ling Wang, Haitang Hu, Jielai Xia
AIM AND BACKGROUND: Proton pump inhibitors (PPIs) are the main drugs for the treatment of reflux esophagitis. Phase II clinical trials showed that, compared with Esomeprazole, the new PPI Ilaparazole is great in terms of efficacy for reflux symptoms relief and curling for esophagitis. The aim of this study was to confirm suitable dose of Ilaparazole in the treatment of reflux esophagitis. METHODS: This study used a randomized, double-blind, parallel positive drug control, multi-center design...
March 11, 2018: Contemporary Clinical Trials
Scott A Mosley, J Kevin Hicks, Diane G Portman, Kristine A Donovan, Priya Gopalan, Jessica Schmit, Jason Starr, Natalie Silver, Yan Gong, Taimour Langaee, Mike Clare-Salzler, Petr Starostik, Young D Chang, Sahana Rajasekhara, Joshua E Smith, Heloisa P Soares, Thomas J George, Howard L McLeod, Larisa H Cavallari
INTRODUCTION: Pain is one of the most burdensome symptoms associated with cancer and its treatment, and opioids are the cornerstone of pain management. Opioid therapy is empirically selected, and patients often require adjustments in therapy to effectively alleviate pain or ameliorate adverse drug effects that interfere with quality of life. There are data suggesting CYP2D6 genotype may contribute to inter-patient variability in response to opioids through its effects on opioid metabolism...
March 10, 2018: Contemporary Clinical Trials
R Modi, K R Amico, A Knudson, A O Westfall, J Keruly, H M Crane, E B Quinlivan, C Golin, J Willig, A Zinski, R Moore, S Napravnik, L Bryan, M S Saag, M J Mugavero
In the first year after HIV diagnosis, patients are simultaneously processing with their diagnosis, typically with an emotional component, while also developing a routine of regular medical care visits and antiretroviral therapy (ART) adherence. Maintaining "HIV adherence" and integrating it into one's daily life is required to sustain viral load suppression (VS) over time. The HIV care continuum or "treatment cascade," an epidemiological snapshot of the national epidemic in the United States (US), indicates that a minority of persons living with HIV (PLWH) have achieved VS...
March 8, 2018: Contemporary Clinical Trials
Olivia I Okereke, Charles F Reynolds, David Mischoulon, Grace Chang, Nancy R Cook, Trisha Copeland, Georgina Friedenberg, Julie E Buring, JoAnn E Manson
RATIONALE: Depression is a leading cause of disease burden and disability for older adults; thus, prevention is a priority. Biologic and observational data support potential mental health benefits of vitamin D and omega-3 fatty acids; however, it is unclear whether these supplements can prevent late-life depression. DESIGN: We describe the novel methodology of a large-scale prevention study: VITAL-DEP (VITamin D and OmegA-3 TriaL-Depression Endpoint Prevention), an ancillary to the VITAL trial...
March 8, 2018: Contemporary Clinical Trials
Kurt Barnhart, Linda Giudice, Steve Young, Tracey Thomas, Michael P Diamond, James Segars, Wahid A Youssef, Stephen Krawetz, Nanette Santoro, Esther Eisenberg, Heping Zhang
OBJECTIVE: Endometriosis is a chronic, estrogen dependent condition that affects 5-10% of reproductive aged women and is associated with pelvic pain and infertility. As the approach to therapy shifts from surgical ablation to pharmacological control, a non-surgical mode of diagnosis would be desirable. The ENDOmarker study was designed by the NICHD Reproductive Medicine Network (RMN) to obtain well characterized and phenotyped bio specimens in a standardized fashion from women with and without endometriosis...
March 7, 2018: Contemporary Clinical Trials
Lynn DeBar, Lindsay Benes, Allison Bonifay, Richard A Deyo, Charles R Elder, Francis J Keefe, Michael C Leo, Carmit McMullen, Meghan Mayhew, Ashli Owen-Smith, David H Smith, Connie M Trinacty, William M Vollmer
BACKGROUND: Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care...
March 6, 2018: Contemporary Clinical Trials
Danielle E Ramo, Manpreet Kaur, Ella S Corpuz, Derek D Satre, Kevin Delucchi, Sandra A Brown, Judith J Prochaska
INTRODUCTION: Tobacco and alcohol often are used simultaneously by young adults, and their co-use is associated with greater health consequences than from single use. Social media platforms offer low cost and highly accessible channels to reach and engage young people in substance use interventions. The current trial seeks to compare the Facebook Tobacco Status Project (TSP) smoking cessation intervention to an intervention targeting both tobacco use and heavy episodic drinking (TSP + ALC) among young adults who use both substances...
March 3, 2018: Contemporary Clinical Trials
Lisa G Rosas, Nan Lv, Kristen M J Azar, Lan Xiao, Steven P Hooker, Megan A Lewis, Patricia Zavella, Elizabeth M Venditti, Jun Ma
Latino men bear a disproportionate burden of obesity, diabetes, and cardiovascular disease. However, limited behavioral lifestyle intervention research has focused on Latino men. This trial compares two approaches to weight loss for overweight and obese Latino men: 1) HOMBRE is a culturally adapted intervention that provides individual choice of either self-directed online videos, coach-facilitated in-person groups, and coach-facilitated online groups; and 2) a minimal intensity intervention that uses online videos with a coach available, if solicited by the participant...
March 2, 2018: Contemporary Clinical Trials
Kan Li, Sammy Yuan, William Wang, ShuyanSabrina Wan, Paulette Ceesay, Joseph F Heyse, Shahrul Mt-Isa, Sheng Luo
Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle...
March 2, 2018: Contemporary Clinical Trials
Linda K Ko, Eileen Rillamas-Sun, Sonia Bishop, Oralia Cisneros, Sarah Holte, Beti Thompson
BACKGROUND: Hispanic children are disproportionally overweight and obese compared to their non-Hispanic white counterparts in the US. Community-wide, multi-level interventions have been successful to promote healthier nutrition, increased physical activity (PA), and weight loss. Using community-based participatory approach (CBPR) that engages community members in rural Hispanic communities is a promising way to promote behavior change, and ultimately weight loss among Hispanic children...
February 28, 2018: Contemporary Clinical Trials
Dianne S Ward, Amber E Vaughn, Derek Hales, Anthony J Viera, Ziya Gizlice, Lori A Bateman, Anna H Grummon, Gabriela Arandia, Laura A Linnan
BACKGROUND: Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. METHODS: Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff...
February 28, 2018: Contemporary Clinical Trials
Amanda L Gentry, Susan M Sereika, Frances E Casillo, Mary E Crisafio, Patrick T Donahue, George A Grove, Anna L Marsland, Jennifer C Watt, Catherine M Bender
The Exercise Program in Cancer and Cognition (EPICC) Study is a randomized controlled trial designed to test the effects of moderate-intensity aerobic exercise on cognitive function in postmenopausal women with early-stage breast cancer during the first six months of aromatase inhibitor therapy. It is estimated that up to 75% of survivors of breast cancer experience cognitive impairment related to disease and treatment. At present, there are no known interventions to improve or manage cognitive function for women with breast cancer...
February 28, 2018: Contemporary Clinical Trials
Thomas Bengtsson, Jonas Román, Tore Persson
A planned change from Bricanyl® (terbutaline) Turbuhaler® M2 to M3 device required a pharmacodynamic study to evaluate therapeutic equivalence of the two devices. Because of the flat dose-response curve for this type of agent over this dose range when assessing bronchodilation, a bronchoprotection study was considered more feasible. In this double-blind, double-dummy, multicentre, single-dose, two-factor, crossover study, patients with stable mild-to-moderate asthma were randomised to 0.5 or 1.5 mg terbutaline via Turbuhaler® M2 or Turbuhaler® M3 followed by a methacholine challenge test...
February 21, 2018: Contemporary Clinical Trials
Joshua N Sampson, Allan Hildesheim, Rolando Herrero, Paula Gonzalez, Aimee Kreimer, Mitchell H Gail
Cervical cancer is a leading cause of cancer mortality in women worldwide. Human papillomavirus (HPV) types 16 and 18 cause about 70% of all cervical cancers. Clinical trials have demonstrated that three doses of either commercially available HPV vaccine, Cervarix or Gardasil, prevent most new HPV 16/18 infections and associated precancerous lesions. Based on evidence of immunological non-inferiority, 2-dose regimens have been licensed for adolescents in the United States, European Union, and elsewhere. However, if a single dose were effective, vaccine costs would be reduced substantially and the logistics of vaccination would be greatly simplified, enabling vaccination programs in developing countries...
February 20, 2018: Contemporary Clinical Trials
Michael J Grayling, James M S Wason, Adrian P Mander
Multi-arm multi-stage trial designs can bring notable gains in efficiency to the drug development process. However, for normally distributed endpoints, the determination of a design typically depends on the assumption that the patient variance in response is known. In practice, this will not usually be the case. To allow for unknown variance, previous research explored the performance of t-test statistics, coupled with a quantile substitution procedure for modifying the stopping boundaries, at controlling the familywise error-rate to the nominal level...
February 20, 2018: Contemporary Clinical Trials
Lauren A Burt, Sharon Gaudet, Michelle Kan, Marianne S Rose, Emma O Billington, Steven K Boyd, David A Hanley
The optimum dose of vitamin D and corresponding serum 25-hydroxyvitamin D (25OHD) concentration for bone health is still debated and some health practitioners are recommending doses well above the Canada/USA recommended Dietary Reference Intake (DRI). We designed a three-year randomized double-blind clinical trial investigating whether there are dose-dependent effects of vitamin D supplementation above the Dietary Reference Intake (DRI) on bone health. The primary aims of this study are to assess, whether supplementation of vitamin D3 increases 1) volumetric bone mineral density measured by high-resolution peripheral quantitative computed tomography (HR-pQCT); 2) bone strength assessed by finite element analysis, and 3) areal bone mineral density by dual X-ray absorptiometry (DXA)...
February 19, 2018: Contemporary Clinical Trials
Taghrid Asfar, Alberto J Caban-Martinez, Laura A McClure, Estefania C Ruano-Herreria, Danielle Sierra, G Gilford Clark, Daniel Samano, Noella A Dietz, Kenneth D Ward, Kristopher L Arheart, David J Lee
Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers...
February 14, 2018: Contemporary Clinical Trials
Anna M Gorczyca, Richard A Washburn, Lauren Ptomey, Matthew S Mayo, Debra K Sullivan, Cheryl A Gibson, Robert Lee, Sarah Stolte, Joseph E Donnelly
Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are unlikely to be trained to provide effective weight management. Remote delivery using group phone conferences (GP) or individual phone calls (IP), by staff associated with rural clinics eliminates the need for travel to attend on-site meetings...
February 14, 2018: Contemporary Clinical Trials
Teletia Taylor, Chiranjeev Dash, Kepher Makambi, Xiaoyang Ma, Vanessa Sheppard, Lucile L Adams-Campbell
PURPOSE: African-American women have a higher incidence and mortality from breast cancer compared to most other racial/ethnic groups. African-American women are also more likely to be metabolically unhealthy than White women. Several studies have suggested that metabolic syndrome affects health-related quality of life (HRQoL). Despite numerous exercise studies reporting improvements in metabolic syndrome, no study to date has examined the effect of exercise on HRQoL in metabolically unhealthy African-American women...
February 8, 2018: Contemporary Clinical Trials
Sue-Jane Wang, Hua Peng, Hsien-Ming James Hung
A planned adaptation to sample size in an ongoing trial aims at providing an opportunity to modify design assumptions made at the trial planning stage. Reassessment of sample size in an ongoing trial may be performed in a non-comparative or a comparative fashion, either with or without use of external data that surface. We review the completed new drug applications (NDAs) and biologic license applications (BLAs) submitted since 2000 to cardio-renal, neurology and psychiatry drug products divisions of Center for Drug Evaluation and Research, U...
February 7, 2018: Contemporary Clinical Trials
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