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Clinical trial recruitment

Paul P Walker, Pasquale P Pompilio, Paolo Zanaboni, Trine S Bergmo, Kaiu Prikk, Andrei Malinovschi, Josep M Montserrat, Jo Middlemass, Silvana Šonc, Giulia Munaro, Dorjan Marušič, Ruth Sepper, Roberto Rosso, A Niroshan Siriwardena, Christer Janson, Ramon Farre, Peter M A Calverley, Raffaele L Dellaca'
RATIONALE: Early detection of COPD exacerbations using tele-monitoring of physiological variables might reduce the frequency of hospitalisation. OBJECTIVES: To evaluate the efficacy of home monitoring of lung mechanics by the forced oscillation technique (FOT) and cardiac parameters in older COPD patients with co-morbidities. METHODS: This multicentre, randomized clinical trial recruited 312 GOLD grade II-IV COPD patients (median age 71 years [IQR:66-76], 49...
March 20, 2018: American Journal of Respiratory and Critical Care Medicine
Marco Esposito, Rubén Davó, Carlos Marti-Pages, Ada Ferrer-Fuertes, Carlo Barausse, Roberto Pistilli, Daniela Rita Ippolito, Pietro Felice
PURPOSE: To compare the clinical outcome of immediately loaded cross-arch maxillary prostheses supported by zygomatic implants vs conventional implants placed in augmented bone. MATERIALS AND METHODS: A total of 71 edentulous patients with severely atrophic maxillas, who did not have sufficient bone volume to place dental implants or when it was possible to place only two implants in the front area (minimal diameter 3.5 mm and length of 8 mm) and less than 4.0 mm of bone height subantrally, were randomised according to a parallel group design...
2018: European Journal of Oral Implantology
Chao-Liang Tang, Juan Li, Zhe-Tao Zhang, Bo Zhao, Shu-Dong Wang, Hua-Ming Zhang, Si Shi, Yang Zhang, Zhong-Yuan Xia
Dexmedetomidine has sedative, anxiolytic, analgesic, anti-sympathetic, and anti-shivering effects. Dexmedetomidine might be effective in combination with sevoflurane for anesthesia, but prospective randomized controlled clinical trials with which to verify this hypothesis are lacking. In total, 120 patients who underwent embolization of an intracranial aneurysm were recruited from Anhui Provincial Hospital and Renmin Hospital of Wuhan University of China and randomly allocated to two groups. After intraoperative administration of 2% to 3% sevoflurane inhalation, one group of patients received pump-controlled intravenous injection of 1...
February 2018: Neural Regeneration Research
Maritta Välimäki, Kaisa Mishina, Johanna K Kaakinen, Suvi K Holm, Jukka Vahlo, Markus Kirjonen, Virve Pekurinen, Olli Tenovuo, Jyrki Korkeila, Heikki Hämäläinen, Jaana Sarajuuri, Pekka Rantanen, Tage Orenius, Aki Koponen
BACKGROUND: Traumatic brain injury (TBI) is a major health problem that often requires intensive and long-term rehabilitation. OBJECTIVE: The aim of this study was to determine whether rehabilitative digital gaming facilitates cognitive functioning and general well-being in people with TBI. METHODS: A total of 90 Finnish-speaking adults with TBI (18-65 years) were recruited from an outpatient neuroscience clinic. The participants were randomly allocated to one of the three groups: a rehabilitation gaming group (n=29, intervention), an entertainment gaming group (n=29, active control), or a passive control group (n=32)...
March 19, 2018: Journal of Medical Internet Research
Jing Tian, Jiangping Xue, Xiaojuan Hu, Qinghua Han, Yanbo Zhang
BACKGROUND: Due to a lack of an appropriate disease-specific patient-reported outcome (PRO) instrument for chronic heart failure including its social support and treatment aspects in China, this study was performed to develop a patient-reported outcome measure (PROM) for patients with chronic heart failure and evaluate its reliability, validity, and feasibility. METHODS: According to the standard PROM guidelines established by the Food and Drug Administration, an item pool was formed by reviewing a large amount of relevant literature and interviewing patients with chronic heart failure about their main symptoms...
March 20, 2018: Health and Quality of Life Outcomes
Jo Frost, Fiona Robinson, Judi Hibberd
PURPOSE OF REVIEW: Dysphagia in adults arises from a range of causes including acquired neurological disorders and some cancers. Previous research has suggested that treatment using neuromuscular electrical stimulation (NMES) when used in conjunction with conventional therapy is effective. This review describes the recent literature and a small prospective case series carried out in the United Kingdom. This study contributed to support National Institute of Clinical Excellence (NICE) guidance for clinicians who wish to include NMES in a rehabilitation programme for dysphagic patients, specifically with reference to safety and the impact on swallowing function of this intervention...
March 16, 2018: Current Opinion in Otolaryngology & Head and Neck Surgery
Natasha A Lannin, Louise Ada, Coralie English, Julie Ratcliffe, Maria Crotty
Rationale Although clinical practice guidelines recommend that management of moderate to severe spasticity include the use of botulinum toxin-A in conjunction with therapy, there is currently no evidence to support the addition of therapy. Aims To determine the effect and cost-benefit of adding evidence-based movement training to botulinum toxin-A. Sample size estimate A total of 136 participants will be recruited in order to be able to detect a between-group difference of seven points on the Goal Attainment Scale T-score with 80% power at a two-tailed significance level of 0...
January 1, 2018: International Journal of Stroke: Official Journal of the International Stroke Society
Steffen Moritz, Karla Spirandelli, Insa Happach, Despina Lion, Fabrice Berna
OBJECTIVES: There is mixed evidence regarding whether patients with obsessive-compulsive disorder (OCD) display substantial neurocognitive deficits. Several studies implicate poor motivation, comorbid disorders, or distraction due to obsessive thoughts as potential causes of secondary malperformance. The present study examined the impact of stereotype threat (i.e., confrontation with a negative stereotype may impair performance) on neuropsychological functioning in individuals with OCD...
March 19, 2018: Journal of the International Neuropsychological Society: JINS
Viktor Fleming, Xiaoying Hu, Rebekka Weber, Vasyl Nagibin, Christopher Groth, Peter Altevogt, Jochen Utikal, Viktor Umansky
The immune system has many sophisticated mechanisms to balance an extensive immune response. Distinct immunosuppressive cells could protect from excessive tissue damage and autoimmune disorders. Tumor cells take an advantage of those immunosuppressive mechanisms and establish a strongly immunosuppressive tumor microenvironment (TME), which inhibits antitumor immune responses, supporting the disease progression. Myeloid-derived suppressor cells (MDSC) play a crucial role in this immunosuppressive TME. Those cells represent a heterogeneous population of immature myeloid cells with a strong immunosuppressive potential...
2018: Frontiers in Immunology
Kana R Jat, Dinesh K Walia, Anju Khairwa
BACKGROUND: Cystic fibrosis is an autosomal recessive multisystem disorder with an approximate prevalence of 1 in 3500 live births. Allergic bronchopulmonary aspergillosis is a lung disease caused by aspergillus-induced hypersensitivity with a prevalence of 2% to 15% in people with cystic fibrosis. The mainstay of treatment includes corticosteroids and itraconazole. The treatment with corticosteroids for prolonged periods of time, or repeatedly for exacerbations of allergic bronchopulmonary aspergillosis, may lead to many adverse effects...
March 18, 2018: Cochrane Database of Systematic Reviews
Titilola Falasinnu, Yashaar Chaichian, Michelle B Bass, Julia F Simard
PURPOSE OF REVIEW: This review evaluated gender and race/ethnic representation in randomized controlled trials (RCTs) of patients with systemic lupus erythematosus (SLE). RECENT FINDINGS: Whites comprise 33% of prevalent SLE cases and comprised 51% of RCT enrollees. Blacks encompass 43% of prevalent SLE cases, but only represented 14% of RCT enrollees. Hispanics comprise 16% of prevalent SLE cases and 21% of RCT enrollees, while Asians comprise 13% of prevalent SLE cases and 10% of RCT enrollees...
March 17, 2018: Current Rheumatology Reports
Sarang Kim, Mitchell McMaster, Susan Torres, Kay L Cox, Nicola Lautenschlager, George W Rebok, Dimity Pond, Catherine D'Este, Ian McRae, Nicolas Cherbuin, Kaarin J Anstey
INTRODUCTION: It has been estimated that a 10%-25% reduction in seven key risk factors could potentially prevent 1.1-3.0 million Alzheimer's disease cases globally. In addition, as dementia is preceded by more subtle cognitive deficits which have substantial social and economic impact, effective preventative interventions would likely have more extensive benefits. The current study evaluates in primary care a multidomain risk-reduction intervention targeting adults with high risk of developing dementia...
March 17, 2018: BMJ Open
Andrew S Kern-Goldberger, Amanda J Hessels, Lisa Saiman, Lynne M Quittell
BACKGROUND: Recruiting both pediatric and adult participants for clinical trials in CF is currently of paramount importance as numerous new therapies are being developed. However, recruitment is challenging as parents of children with CF and adults with CF cite safety concerns as a principal barrier to enrollment. In conjunction with the CF Foundation (CFF) Data Safety Monitoring Board (DSMB), a pilot brochure was developed to inform patients and parents of the multiple levels of safety monitoring; the CFF simultaneously created an infographic representing the safety monitoring process...
March 14, 2018: Journal of Cystic Fibrosis: Official Journal of the European Cystic Fibrosis Society
Antonio Cano-Vindel, Roger Muñoz-Navarro, Leonardo Adrián Medrano, Paloma Ruiz-Rodríguez, César González-Blanch, María Dolores Gómez-Castillo, Antonio Capafons, Fernando Chacón, Francisco Santolaya
BACKGROUND: The Patient Health Questionnaire-4 (PHQ-4) is an ultra-brief self-report consisting of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2). The aim of the present study is to determine the psychometric properties of a computerized version of the PHQ-4 used to detect emotional disorders (anxiety and depression) in the primary care setting. METHOD: A total of 1052 patients with suspected anxiety, depression, or somatic symptoms were recruited from 28 primary care centres participating in the PsicAP trial and completed the full version of the computerized PHQ...
February 16, 2018: Journal of Affective Disorders
Deborah A Hall, Alberto R Ramos, Jeffrey Marc Gelfand, Aleksander Videnovic, Michael Benatar, Carolyn Cahill, Benzi M Kluger, Myla Goldman
OBJECTIVE: To study and provide an update on the state of clinical research in neurology in the United States. METHODS: US American Academy of Neurology members and chairs of departments of neurology were surveyed regarding clinical research in 2016. NIH data on the neuroscience pipeline and extramural grant funding were also collected. RESULTS: The response rate was 32% (n = 254) for nonchair researchers and 58% (n = 67) for department chairs...
March 16, 2018: Neurology
Bastiaan Van Grootven, Lynn McNicoll, Daniel A Mendelson, Susan M Friedman, Katleen Fagard, Koen Milisen, Johan Flamaing, Mieke Deschodt
OBJECTIVE: To find consensus on appropriate and feasible structure, process and outcome indicators for the evaluation of in-hospital geriatric co-management programmes. DESIGN: An international two-round Delphi study based on a systematic literature review (searching databases, reference lists, prospective citations and trial registers). SETTING: Western Europe and the USA. PARTICIPANTS: Thirty-three people with at least 2 years of clinical experience in geriatric co-management were recruited...
March 16, 2018: BMJ Open
Emma Wallin, Fredrika Norlund, Erik Martin Gustaf Olsson, Gunilla Burell, Claes Held, Tommy Carlsson
BACKGROUND: Knowledge about user experiences may lead to insights about how to improve treatment activity in Internet-based cognitive behavioral therapy (iCBT) to reduce symptoms of depression and anxiety among people with a somatic disease. There is a need for studies conducted alongside randomized trials, to explore treatment activity and user experiences related to such interventions, especially among people with older age who are recruited in routine care. OBJECTIVE: The aim of the study was to explore treatment activity, user satisfaction, and usability experiences among patients allocated to treatment in the U-CARE Heart study, a randomized clinical trial of an iCBT intervention for treatment of depression and anxiety following a recent myocardial infarction...
March 16, 2018: Journal of Medical Internet Research
Francisco I Salgado García, Karen J Derefinko, Zoran Bursac, Sarah Hand, Robert C Klesges
Smoking cessation programs are efficacious and have been validated to assist the 10% to 30% of smokers who are ready to quit in the next 30 days. While the majority of smokers want to quit smoking in the future, only 69% are planning to quit within the next year. Planning a Change Easily (PACE) is a nation-wide, telephone-based comparative effectiveness, randomized controlled trial for smokers not ready to quit (SNRTQ). This project, as well as its intervention components, outcomes, and hypotheses are discussed...
March 13, 2018: Contemporary Clinical Trials
Haotian Lin, Li Zhang, Duoru Lin, Wan Chen, Yi Zhu, Chuan Chen, Kevin C Chan, Yizhi Liu, Weirong Chen
BACKGROUND: Visual function and brain function decline concurrently with aging. Notably, cataract patients often present with accelerated age-related decreases in brain function, but the underlying mechanisms are still unclear. Optical structures of the anterior segment of the eyes, such as the lens and cornea, can be readily reconstructed to improve refraction and vision quality. However, the effects of visual restoration on human brain function and structure remain largely unexplored...
March 7, 2018: EBioMedicine
David Chi-Leung Lam, Hoi-Hin Kwok, Wai-Cho Yu, Fanny Wai-San Ko, Cheuk-Yin Tam, Arthur Chun-Wing Lau, Daniel Yee-Tak Fong, Mary Sau-Man Ip
BACKGROUND: Club cell protein-16 (CC16) expression has been associated with smoking-related lung function decline. The study hypothesis was that CC16 expression in both serum and bronchial epithelium is associated with lung function decline in smokers, and exposure to cigarette smoke will lead to reduction in CC16 expression in bronchial epithelial cells. METHODS: In a cohort of community-based male Chinese subjects recruited for lung function test in 2000, we reassessed their lung function ten years later and measured serum levels of CC16...
March 16, 2018: BMC Pulmonary Medicine
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