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https://www.readbyqxmd.com/read/28921778/alcohol-e-help-study-protocol-for-a-web-based-self-help-program-to-reduce-alcohol-use-in-adults-with-drinking-patterns-considered-harmful-hazardous-or-suggestive-of-dependence-in-middle-income-countries
#1
Michael P Schaub, Marcela Tiburcio, Nora Martinez, Atul Ambekar, Yatan Pal Singh Balhara, Andreas Wenger, André Luiz Monezi Andrade, Dzianis Padruchny, Sergey Osipchik, Elise Gehring, Vladimir Poznyak, Dag Rekve, Maria Lucia Oliveira Souza-Formigoni
BACKGROUND AND AIMS: Given the scarcity of alcohol prevention and alcohol use disorder treatments in many low and middle-income countries, the World Health Organization launched an e-health portal on alcohol and health that includes a Web-based self-help program. This paper presents the protocol for a multicenter randomised controlled trial (RCT) to test the efficacy of the Internet-based self-help intervention to reduce alcohol use. DESIGN: Two-arm RCT with follow-up 6 months after randomisation...
September 17, 2017: Addiction
https://www.readbyqxmd.com/read/28919766/cognitive-behavioral-therapy-for-somatic-symptom-disorders-in-later-life-a-prospective-comparative-explorative-pilot-study-in-two-clinical-populations
#2
Michelle Jh Verdurmen, Arjan C Videler, Astrid M Kamperman, David Khasho, Christina M van der Feltz-Cornelis
BACKGROUND: Elderly patients with somatic symptom disorder (SSD) put a great burden on the health care delivery system. Cognitive behavioral therapy (CBT) is effective in adults with SSD. However, no studies have been conducted yet into CBT for SSD in later life. OBJECTIVES: We explored the feasibility of CBT for SSD in the elderly. METHODS: This is a prospective pilot study comparing two outpatient specialty mental health settings for adults (<60 years; n=13) and for elderly patients (≥60 years; n=9) with SSD...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28916304/rationale-and-design-of-the-arrest-trial-investigating-mesenchymal-stem-cells-in-the-treatment-of-small-aaa
#3
S Keisin Wang, Linden A Green, Ashley R Gutwein, Natalie A Drucker, Raghu L Motaganahalli, Andres Fajardo, Clifford C Babbey, Michael P Murphy
BACKGROUND: Abdominal aortic aneurysms (AAA) are a major source of morbidity and mortality despite continuing advances in surgical technique and care. Although the inciting factors for AAA development continue to be elusive, accumulating evidence suggests a significant peri-aortic inflammatory response leading to degradation and dilation of the aortic wall. Previous human trials have demonstrated safety and efficacy of mesenchymal stem cells (MSCs) in the treatment of inflammation-related pathologies such as rheumatoid arthritis, graft vs host disease, and transplant rejection...
September 12, 2017: Annals of Vascular Surgery
https://www.readbyqxmd.com/read/28915904/tiga-cub-manualised-psychoanalytic-child-psychotherapy-versus-treatment-as-usual-for-children-aged-5-11-years-with-treatment-resistant-conduct-disorders-and-their-primary-carers-study-protocol-for-a-randomised-controlled-feasibility-trial
#4
Elizabeth Edginton, Rebecca Walwyn, Kayleigh Burton, Robert Cicero, Liz Graham, Sadie Reed, Sandy Tubeuf, Maureen Twiddy, Alex Wright-Hughes, Lynda Ellis, Dot Evans, Tom Hughes, Nick Midgley, Paul Wallis, David Cottrell
BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD...
September 15, 2017: Trials
https://www.readbyqxmd.com/read/28915861/informed-decision-making-with-and-for-people-with-dementia-efficacy-of-the-prodecide-education-program-for-legal-representatives-protocol-of-a-randomized-controlled-trial-prodecide-rct
#5
Julia Lühnen, Burkhard Haastert, Ingrid Mühlhauser, Tanja Richter
BACKGROUND: In Germany, the guardianship system provides adults who are no longer able to handle their own affairs a court-appointed legal representative, for support without restriction of legal capacity. Although these representatives only rarely are qualified in healthcare, they nevertheless play decisive roles in the decision-making processes for people with dementia. Previously, we developed an education program (PRODECIDE) to address this shortcoming and tested it for feasibility...
September 15, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28915826/acupuncture-lowering-blood-pressure-for-secondary-prevention-of-stroke-a-study-protocol-for-a-multicenter-randomized-controlled-trial
#6
Yu-Zheng Du, Xin-Xin Gao, Cheng-Ting Wang, Hai-Zhen Zheng, Yun Lei, Meng-Han Wu, Xue-Min Shi, Hai-Peng Ban, Wen-Long Gu, Xiang-Gang Meng, Mao-Ti Wei, Chun-Xiao Hu
BACKGROUND: Stroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke. METHODS: This is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group...
September 15, 2017: Trials
https://www.readbyqxmd.com/read/28899412/the-effect-of-information-about-the-benefits-and-harms-of-mammography-on-women-s-decision-making-study-protocol-for-a-randomized-controlled-trial
#7
Misericòrdia Carles, Montserrat Martínez-Alonso, Anna Pons, Maria José Pérez-Lacasta, Lilisbeth Perestelo-Pérez, Maria Sala, Carmen Vidal, Montse Garcia, Ana Toledo-Chávarri, Núria Codern, Maria Feijoo-Cid, Anabel Romero, Roger Pla, Jorge Soler-González, Xavier Castells, Montserrat Rué
BACKGROUND: The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening...
September 12, 2017: Trials
https://www.readbyqxmd.com/read/28884937/a-japanese-population-based-meta-analysis-of-vonoprazan-versus-ppi-for-helicobacter-pylori-eradication-therapy-is-superiority-an-illusion
#8
REVIEW
Shou Quan Dong, Tikka Prabhjot Singh, Xin Wei, Huang Yao, Hong Ling Wang
BACKGROUND: Vonoprazan (VPZ) is a novel acid suppressant that has been used in Helicobacter pylori (H. pylori) eradication therapies in recent years. However, the efficacy and safety of VPZ vs proton-pump inhibitor (PPI) in H. pylori eradication therapies remain controversial. OBJECTIVE: To perform a meta-analysis in order to assess the efficacy and safety of VPZ vs PPI for H. pylori eradication. MATERIALS AND METHODS: The PubMed, EMBASE, and Cochrane Library databases were searched up to July 10, 2017, for relevant randomized controlled trials (RCTs) and nonrandomized clinical studies (NRCTs)...
September 8, 2017: Helicobacter
https://www.readbyqxmd.com/read/28882167/implementation-and-results-of-an-integrated-data-quality-assurance-protocol-in-a-randomized-controlled-trial-in-uttar-pradesh-india
#9
Jonathon D Gass, Anamika Misra, Mahendra Nath Singh Yadav, Fatima Sana, Chetna Singh, Anup Mankar, Brandon J Neal, Jennifer Fisher-Bowman, Jenny Maisonneuve, Megan Marx Delaney, Krishan Kumar, Vinay Pratap Singh, Narender Sharma, Atul Gawande, Katherine Semrau, Lisa R Hirschhorn
BACKGROUND: There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes...
September 7, 2017: Trials
https://www.readbyqxmd.com/read/28877949/feasibility-randomised-multicentre-double-blind-double-dummy-controlled-trial-of-anakinra-an-interleukin-1-receptor-antagonist-versus-intramuscular-methylprednisolone-for-acute-gout-attacks-in-patients-with-chronic-kidney-disease-asgard-protocol-study
#10
Gowrie Balasubramaniam, Trisha Parker, David Turner, Mike Parker, Jonathan Scales, Patrick Harnett, Michael Harrison, Khalid Ahmed, Sweta Bhagat, Thiraupathy Marianayagam, Costantino Pitzalis, Christian Mallen, Edward Roddy, Mike Almond, Bhaskar Dasgupta
INTRODUCTION: Acute gout occurs in people with chronic kidney disease, who are commonly older people with comorbidities such as hypertension, heart disease and diabetes. Potentially harmful treatments are administered to these vulnerable patients due to a lack of clear evidence. Newly available treatment that targets a key inflammatory pathway in acute gout attacks provides an opportunity to undertake the first-ever trial specifically looking treating people with kidney disease. This paper describes the protocol for a feasibility randomised controlled trial (RCT) comparing anakinra, a novel interleukin-1 antagonist versus steroids in people with chronic kidney disease (ASGARD)...
September 5, 2017: BMJ Open
https://www.readbyqxmd.com/read/28877737/erratum-to-a-manual-based-vocational-rehabilitation-program-for-patients-with-an-acquired-brain-injury-study-protocol-of-a-pragmatic-randomized-controlled-trial-rct
#11
Louise K Hoeffding, Maria Haahr Nielsen, Morten A Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K Kjær, Kristoffer Sølvsten Burgdorf, Kirsten Jensen Quas, Trine Schow
No abstract text is available yet for this article.
September 6, 2017: Trials
https://www.readbyqxmd.com/read/28870059/publication-trends-of-study-protocols-in-rehabilitation
#12
Tiago S Jesus, Heather L Colquhoun
BACKGROUND: Growing evidence points for the need to publish study protocols in the health field. AIM: To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. DESIGN: Observational study using publication data and its indexation in PubMed. SETTING: Not applicable. POPULATION: Not applicable...
September 4, 2017: European Journal of Physical and Rehabilitation Medicine
https://www.readbyqxmd.com/read/28868042/cognitive-behavioral-therapy-vs-eye-movement-desensitization-and-reprocessing-for-treating-panic-disorder-a-randomized-controlled-trial
#13
Ferdinand Horst, Brenda Den Oudsten, Wobbe Zijlstra, Ad de Jongh, Jill Lobbestael, Jolanda De Vries
Objective: Cognitive Behavioral Therapy (CBT) is an effective intervention for patients with panic disorder (PD). From a theoretical perspective, Eye Movement Desensitization and Reprocessing (EMDR) therapy could also be useful in the treatment of PD because: (1) panic attacks can be experienced as life threatening; (2) panic memories specific to PD resemble traumatic memories as seen in posttraumatic stress disorder (PTSD); and (3) PD often develops following a distressing life event. The primary objective of this Randomized Controlled Trial (RCT), was to compare EMDR therapy with CBT for PD and determine whether EMDR is not worse than CBT in reducing panic symptoms and improving Quality Of Life (QOL)...
2017: Frontiers in Psychology
https://www.readbyqxmd.com/read/28860107/project-stronger-together-protocol-to-test-a-dyadic-intervention-to-improve-engagement-in-hiv-care-among-sero-discordant-male-couples-in-three-us-cities
#14
Rob Stephenson, Nicolas A Suarez, Robert Garofalo, Marco A Hidalgo, Samuel Hoehnle, Jennie Thai, Matthew J Mimiaga, Emily Brown, Anna Bratcher, Taylor Wimbly, Patrick Sullivan
BACKGROUND: An estimated one- to-two-thirds of new human immunodeficiency virus (HIV) infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this fact, there remains a lack of prevention interventions that focus on male sero-discordant dyads. Interventions that provide male couples with skills to manage HIV risk, and to support each other towards active engagement in HIV prevention and care, are urgently needed. OBJECTIVE: The objective of this paper is to describe the protocol for an innovative dyadic intervention (Stronger Together) that combines couples' HIV testing and dyadic adherence counseling to improve treatment adherence and engagement in care among HIV sero-discordant male couples in the United States...
August 31, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28854590/double-blind-randomized-controlled-trial-of-letrozole-versus-clomiphene-citrate-in-subfertile-women-with-polycystic-ovarian-syndrome
#15
S A Amer, J Smith, A Mahran, P Fox, A Fakis
STUDY QUESTION: Would letrozole as a primary ovulation induction agent generate better pregnancy rates than clomiphene citrate (CC) in subfertile women with anovulatory polycystic ovarian syndrome (PCOS)? SUMMARY ANSWER: Participants receiving letrozole as a primary treatment achieved a significantly (P = 0.022) higher clinical pregnancy rate per patient (61.2%) compared to CC (43.0%). WHAT IS KNOWN ALREADY: According to a recent Cochrane systematic review (2014), letrozole appears to improve live-birth (LB) and pregnancy rates in anovulatory women with PCOS, compared to CC...
August 1, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28851276/effects-of-horticultural-therapy-on-elderly-health-protocol-of-a-randomized-controlled-trial
#16
Hui Yu Chan, Roger Chun-Man Ho, Rathi Mahendran, Kheng Siang Ng, Wilson Wai-San Tam, Iris Rawtaer, Chay Hoon Tan, Anis Larbi, Lei Feng, Angelia Sia, Maxel Kian-Wee Ng, Goh Lee Gan, Ee Heok Kua
BACKGROUND: Due to a rapidly ageing population in the world, it is increasingly pertinent to promote successful ageing strategies which are cost-effective, easily accessible, and more likely to be acceptable to the elderly. Past research associates exposure to natural environments and horticultural therapy (HT) with positive psychological, social and physical health benefits. This Randomized Controlled Trial (RCT) is designed to evaluate the efficacy of HT in promoting Asian elderly' mental health, cognitive functioning and physical health...
August 29, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/28838886/smartphone-enabled-health-coaching-intervention-imove-to-promote-long-term-maintenance-of-physical-activity-in-breast-cancer-survivors-protocol-for-a-feasibility-pilot-randomized-controlled-trial
#17
Paul Ritvo, Maya Obadia, Daniel Santa Mina, Shabbir Alibhai, Catherine Sabiston, Paul Oh, Kristin Campbell, David McCready, Leslie Auger, Jennifer Michelle Jones
BACKGROUND: Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors...
August 24, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28836375/a-brief-motivational-interviewing-as-an-adjunct-to-periodontal-therapy-a-potential-tool-to-reduce-relapse-in-oral-hygiene-behaviours-a-three-year-study
#18
J Stenman, J L Wennström, K H Abrahamsson
OBJECTIVES: To evaluate (ii) whether inclusion of a single motivational interviewing (MI) session, as an adjunct to periodontal therapy, might be beneficial for preventing relapse in oral hygiene behaviours among patients treated for chronic periodontitis and (ii) whether individual and clinical characteristics can be of predictive value for retention of sufficient oral hygiene behaviours. MATERIAL & METHODS: This 3-year follow-up of a previously reported randomized controlled trial (RCT) study of 6-month duration included 26 patients...
August 24, 2017: International Journal of Dental Hygiene
https://www.readbyqxmd.com/read/28830570/identifying-additional-studies-for-a-systematic-review-of-retention-strategies-in-randomised-controlled-trials-making-contact-with-trials-units-and-trial-methodologists
#19
Valerie Brueton, Jayne F Tierney, Sally Stenning, Greta Rait
BACKGROUND: Search strategies for systematic reviews aim to identify all evidence relevant to the research question posed. Reports of methodological research can be difficult to find leading to biased results in systematic reviews of research methodology. Evidence suggests that contact with investigators can help to identify unpublished research. To identify additional eligible randomised controlled trials (RCTs) for a Cochrane systematic review of strategies to improve retention in RCTs, we conducted a survey of UK clinical trials units (CTUs) and made contact with RCT methodologists...
August 22, 2017: Systematic Reviews
https://www.readbyqxmd.com/read/28827270/study-protocol-for-a-randomised-controlled-trial-of-meniscal-surgery-compared-with-exercise-and-patient-education-for-treatment-of-meniscal-tears-in-young-adults
#20
Søren Thorgaard Skou, Martin Lind, Per Hölmich, Hans Peter Jensen, Carsten Jensen, Muhammad Afzal, Uffe Jørgensen, Jonas Bloch Thorlund
INTRODUCTION: Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears...
August 21, 2017: BMJ Open
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