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https://www.readbyqxmd.com/read/29326183/transvaginal-natural-orifice-transluminal-endoscopic-surgery-vnotes-adnexectomy-for-benign-pathology-compared-with-laparoscopic-excision-notable-a-protocol-for-a-randomised-controlled-trial
#1
Jan Filip Baekelandt, Peter A De Mulder, Ilse Le Roy, Chantal Mathieu, Annouschka Laenen, Paul Enzlin, Steven Weyers, Ben W J Mol, Jan J A Bosteels
INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) uses natural orifices to access the cavities of the human body to perform surgical interventions. NOTES limits the magnitude of surgical trauma and potentially reduces postoperative pain. Our group published a protocol on a randomised study comparing transvaginal NOTES (vNOTES) versus laparoscopy for hysterectomy (HALON). We simultaneously designed a similar randomised controlled trial (RCT) comparing vNOTES with laparoscopy for adnexectomy...
January 10, 2018: BMJ Open
https://www.readbyqxmd.com/read/29326094/a-shared-decision-making-tool-to-prevent-substance-abuse-protocol-for-a-randomized-controlled-trial
#2
Ju Long, Juntao Michael Yuan, Ron Kim Johnson
BACKGROUND: Substance use disorder (SUD) affects over 20 million adults and costs over $700 billion annually in the United States. It is one the greatest health care challenges we face. OBJECTIVE: This research project seeks to enhance the standard practice of Screening, Brief Intervention, and Referral to Treatment (SBIRT) through a mobile solution easily incorporated into primary care that will promote shared decision making and increase referral and adherence to specialty care through continued follow-up care...
January 11, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/29325517/a-cluster-randomised-controlled-trial-evaluating-the-effectiveness-and-cost-effectiveness-of-the-daily-mile-on-childhood-obesity-and-wellbeing-the-birmingham-daily-mile-protocol
#3
Katie Breheny, Peymane Adab, Sandra Passmore, James Martin, Emma Lancashire, Karla Hemming, Emma Frew
BACKGROUND: Childhood obesity prevention is a public health priority. Children spend a large proportion of their waking time in school; therefore this is an appropriate setting to implement obesity prevention initiatives. Anecdotal reports suggest that implementing The Daily Mile in schools has had positive effects on childhood obesity, academic attainment and wellbeing. This trial aims to measure the effectiveness of The Daily Mile for improving health and wellbeing. METHODS: This protocol describes a cluster randomised controlled trial (RCT) in 40 primary schools located in Birmingham, UK...
January 11, 2018: BMC Public Health
https://www.readbyqxmd.com/read/29317417/patients-and-therapists-experiences-with-a-new-treatment-programme-for-eating-disorders-that-combines-physical-exercise-and-dietary-therapy-the-ped-t-trial-a-qualitative-study-protocol
#4
Gunn Pettersen, Jan H Rosenvinge, Maria Bakland, Rolf Wynn, Therese Fostervold Mathisen, Jorunn Sundgot-Borgen
INTRODUCTION: Women with bulimia nervosa and binge eating disorder often suffer for many years before they seek professional help. Evidence-based treatments like cognitive-behavioural therapy (CBT) might be poorly accessible, and about 50% of those who receive CBT respond to it. Such outcome may reflect the heterogeneous nature of eating disorders, and addressing this heterogeneity calls for expanding the portfolio of treatment options. In particular, it is important to explore such options' acceptability, tolerability and affordability expressed through experiences with the treatment...
January 8, 2018: BMJ Open
https://www.readbyqxmd.com/read/29316962/hopon-hyperbaric-oxygen-for-the-prevention-of-osteoradionecrosis-a-randomised-controlled-trial-of-hyperbaric-oxygen-to-prevent-osteoradionecrosis-of-the-irradiated-mandible-study-protocol-for-a-randomised-controlled-trial
#5
Richard Shaw, Christopher Butterworth, Binyam Tesfaye, Matthew Bickerstaff, Susanna Dodd, Gary Smerdon, Seema Chauhan, Peter Brennan, Keith Webster, James McCaul, Peter Nixon, Anastasios Kanatas, Paul Silcocks
BACKGROUND: Osteoradionecrosis of the mandible is the most common serious complication of radiotherapy for head and neck malignancy. For decades, hyperbaric oxygen has been employed in efforts to prevent those cases of osteoradionecrosis that are precipitated by dental extractions or implant placement. The evidence for using hyperbaric oxygen remains poor and current clinical practice varies greatly. We describe a protocol for a clinical trial to assess the benefit of hyperbaric oxygen in the prevention of osteoradionecrosis during surgery on the irradiated mandible...
January 10, 2018: Trials
https://www.readbyqxmd.com/read/29314655/randomised-controlled-trial-of-standard-closure-of-stoma-site-versus-biologic-mesh-reinforcement-study-protocol-of-the-rocss-trial
#6
(no author information available yet)
BACKGROUND: Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound dehiscence and incisional hernias. Hernia formation at closed stoma sites occurs in up to 30% of patients. Use of biological meshes in these situations may provide a safe method of reducing these complications, especially long-term incisional hernias. METHOD: The Reinforcement of Closure of Stoma Site (ROCSS) study is a phase III multicentre randomised controlled trial (RCT), with an internal feasibility study...
January 3, 2018: Colorectal Disease: the Official Journal of the Association of Coloproctology of Great Britain and Ireland
https://www.readbyqxmd.com/read/29310679/enhancing-recruitment-using-teleconference-and-commitment-contract-erutecc-study-protocol-for-a-randomised-stepped-wedge-cluster-trial-within-the-effects-trial
#7
Erik Lundström, Eva Isaksson, Per Wester, Ann-Charlotte Laska, Per Näsman
BACKGROUND: Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals...
January 8, 2018: Trials
https://www.readbyqxmd.com/read/29310605/a-randomized-controlled-trial-of-a-skills-training-for-oncologists-and-a-communication-aid-for-patients-to-stimulate-shared-decision-making-about-palliative-systemic-treatment-choice-study-protocol
#8
I Henselmans, E M A Smets, J C J M de Haes, M G W Dijkgraaf, F Y de Vos, H W M van Laarhoven
BACKGROUND: Systemic treatment for advanced cancer offers uncertain and sometimes little benefit while the burden can be high. Hence, treatment decisions require Shared Decision Making (SDM). The CHOICE trial examines the separate and combined effect of oncologist training and a patient communication aid on SDM in consultations about palliative systemic treatment. METHODS: A RCT design with four parallel arms will be adopted. Patients with metastatic or irresectable cancer with a median life expectancy <12 months who meet with a medical oncologist to discuss the start or continuation of palliative systemic treatment are eligible...
January 8, 2018: BMC Cancer
https://www.readbyqxmd.com/read/29306063/many-rcts-may-not-be-justified-a-cross-sectional-analysis-of-the-ethics-and-science-of-randomized-clinical-trials
#9
Julie De Meulemeester, Mark Fedyk, Lucas Jurkovic, Michael Reaume, Dar Dowlatshahi, Grant Stotts, Michel Shamy
OBJECTIVE: We have proposed that three scientific criteria are important to the ethical justification of RCTs: (1) they should be designed around a clear hypothesis; (2) uncertainty should exist around that hypothesis; (3) that uncertainty should be as established through a systematic review. We hypothesized that the majority of a sample of recently-published RCTs would not explicitly incorporate these criteria, therefore rendering them potentially unjustified on scientific grounds. STUDY DESIGN AND SETTING: Cross-sectional analysis of all RCTs published in the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA) in 2015...
January 3, 2018: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29300975/new-application-of-dydrogesterone-as-a-part-of-a-progestin-primed-ovarian-stimulation-protocol-for-ivf-a-randomized-controlled-trial-including-516-first-ivf-icsi-cycles
#10
Sha Yu, Hui Long, Hannah Ya-Ning Chang, Yali Liu, Hongyuan Gao, Jing Zhu, Xinxin Quan, Qifeng Lyu, Yanping Kuang, Ai Ai
STUDY QUESTION: Can dydrogesterone (DYG) be used as an alternative progestin in a progesterone primed ovarian stimulation (PPOS) protocol? SUMMARY ANSWER: DYG can be used as an appropriate alternative progestin in a PPOS protocol. WHAT IS KNOWN ALREADY: PPOS is a new ovarian stimulation regimen based on a freeze-all strategy that uses progestin as an alternative to a GnRH analog for suppressing a premature LH surge during the follicular phase...
December 29, 2017: Human Reproduction
https://www.readbyqxmd.com/read/29295809/feasibility-and-preliminary-effectiveness-of-the-homework-intervention-strategy-ehis-program-to-enhance-male-condom-use-research-protocol
#11
Marta Glowacka, Lucy Yardley, Nicole Stone, Cynthia A Graham
BACKGROUND: Although condoms are effective in reducing the risk of sexually transmitted infections (STIs) and unintended pregnancy, they are still often not used consistently and correctly. Negative impact on sensation and pleasure, ruining the mood, causing problems with maintaining erection, and condom slippage or breakage are some of the reasons given by men explaining why they do not want to use condoms. Although many interventions promoting condom use exist, some of them delivered online are complex and time- and resource-intensive...
January 2, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/29282259/exercise-response-in-parkinson-s-disease-insights-from-a-cross-sectional-comparison-with-sedentary-controls-and-a-per-protocol-analysis-of-a-randomised-controlled-trial
#12
Foteini Mavrommati, Johnny Collett, Marloes Franssen, Andy Meaney, Claire Sexton, Andrea Dennis-West, Jill F Betts, Hooshang Izadi, Marko Bogdanovic, Martin Tims, Andrew Farmer, Helen Dawes
OBJECTIVES: To investigate the acute and adaptation cardiovascular and metabolic training responses in people with Parkinson's disease (pwP). DESIGN: (1) A cross-sectional study of exercise response of pwP compared with sedentary controls and (2) an interventional study of exercise training in pwP. SETTING: Community leisure facilities. PARTICIPANTS: pwP (n=83) and sedentary controls (n=55). INTERVENTIONS: Study 1 included participants from a two-arm-parallel single-blind phase II randomised controlled trial (RCT), that undertook a baseline maximal incremental exercise test and study 2 included those randomised to the exercise group in the RCT, who completed a 6-month weekly exercise programme (n=37)...
December 26, 2017: BMJ Open
https://www.readbyqxmd.com/read/29282092/reporting-quality-of-randomized-controlled-trials-in-patients-with-hiv-on-antiretroviral-therapy-a-systematic-review
#13
REVIEW
Kaori Nagai, Akiko M Saito, Toshiki I Saito, Noriyo Kaneko
BACKGROUND: To allow for correct evaluation of clinical trial results, readers require comprehensive, clear, and highly transparent information on the methodology used and the results obtained. This study aimed to evaluate the quality of reporting in articles on randomized controlled trials (RCTs) of antiretroviral therapy (ART) in the field of HIV/AIDS. METHODS: We searched for original articles on RCTs of ART developed in the field of HIV/AIDS in PubMed database by 5 April 2016...
December 28, 2017: Trials
https://www.readbyqxmd.com/read/29276166/accelerated-titration-of-oxytocin-in-nulliparous-women-with-labour-dystocia-results-of-the-action-pilot-randomized-controlled-trial
#14
Jessica Dy, Jenna Rainey, Mark C Walker, William Fraser, Graeme N Smith, Ruth Rennicks White, Patti Waddell, Ghayath Janoudi, Daniel J Corsi, Shu Qin Wei
OBJECTIVE: The primary objective was to determine the feasibility of a large RCT assessing the effectiveness of an accelerated oxytocin titration (AOT) protocol compared with a standard gradual oxytocin titration (GOT) in reducing the risk of CS in nulliparous women diagnosed with dystocia in the first stage of labour. The secondary objective was to obtain preliminary data on the safety and efficacy of the foregoing AOT protocol. METHODS: This was a multicentre, double-masked, parallel-group pilot RCT...
December 21, 2017: Journal of Obstetrics and Gynaecology Canada: JOGC, Journal D'obstétrique et Gynécologie du Canada: JOGC
https://www.readbyqxmd.com/read/29273079/united-kingdom-frozen-shoulder-trial-uk-frost-multi-centre-randomised-12-month-parallel-group-superiority-study-to-compare-the-clinical-and-cost-effectiveness-of-early-structured-physiotherapy-versus-manipulation-under-anaesthesia-versus-arthroscopic-capsular
#15
Stephen Brealey, Alison L Armstrong, Andrew Brooksbank, Andrew Jonathan Carr, Charalambos P Charalambous, Cushla Cooper, Belen Corbacho, Joseph Dias, Iona Donnelly, Lorna Goodchild, Catherine Hewitt, Ada Keding, Lucksy Kottam, Sarah E Lamb, Catriona McDaid, Matthew Northgraves, Gerry Richardson, Sara Rodgers, Sarwat Shah, Emma Sharp, Sally Spencer, David Torgerson, Francine Toye, Amar Rangan
BACKGROUND: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy...
December 22, 2017: Trials
https://www.readbyqxmd.com/read/29273044/a-randomized-controlled-trial-of-exercise-during-pregnancy-on-maternal-and-neonatal-outcomes-results-from-the-pamela-study
#16
Shana Ginar da Silva, Pedro Curi Hallal, Marlos Rodrigues Domingues, Andréa Dâmaso Bertoldi, Mariângela Freitas da Silveira, Diego Bassani, Inácio Crochemore Mohnsam da Silva, Bruna Gonçalves Cordeiro da Silva, Carolina de Vargas Nunes Coll, Kelly Evenson
BACKGROUND: Women are encouraged to be physically active during pregnancy. Despite available evidence supporting antenatal physical activity to bring health benefits for both the mother and child, the most effective way to prevent some maternal and fetal outcomes is still unclear. The purpose of this study was to evaluate the efficacy of an exercise intervention to prevent negative maternal and newborn health outcomes. METHODS: A randomized controlled trial (RCT) nested into the 2015 Pelotas (Brazil) Birth Cohort Study was carried-out with 639 healthy pregnant women, 213 in the intervention group (IG) and 426 in the control (CG) group...
December 22, 2017: International Journal of Behavioral Nutrition and Physical Activity
https://www.readbyqxmd.com/read/29260419/comparative-effectiveness-of-preoperative-paravertebral-block-for-post-mastectomy-reconstruction-a-systematic-review-of-the-literature
#17
Anaeze C Offodile, Mario A Aycart, Jodi B Segal
INTRODUCTION: Paravertebral block (PVB) has emerged as a viable strategy for improving postoperative outcomes in breast surgery; however, it is unclear whether these benefits extend to recipients of post-mastectomy reconstruction (PMR). METHODS: A systematic search of the PubMed, EMBASE, Web of Science and Cochrane Library electronic databases was conducted for all studies matching the a priori inclusion criteria (inception to 1 March 2017). Independent assessment by two reviewers, in stages, of the title/abstract and full text was performed...
December 19, 2017: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/29258631/attention-bias-modification-augments-cognitive-behavioral-group-therapy-for-social-anxiety-disorder-a-randomized-controlled-trial
#18
Amit Lazarov, Sofi Marom, Naomi Yahalom, Daniel S Pine, Haggai Hermesh, Yair Bar-Haim
BACKGROUND: Cognitive-behavioral group therapy (CBGT) is a first-line treatment for social anxiety disorder (SAD). However, since many patients remain symptomatic post-treatment, there is a need for augmenting procedures. This randomized controlled trial (RCT) examined the potential augmentation effect of attention bias modification (ABM) for CBGT. METHODS: Fifty patients with SAD from three therapy groups were randomized to receive an 18-week standard CBGT with either ABM designed to shift attention away from threat (CBGT + ABM), or a placebo protocol not designed to modify threat-related attention (CBGT + placebo)...
December 20, 2017: Psychological Medicine
https://www.readbyqxmd.com/read/29246188/antibiotic-treatment-in-patients-with-chronic-low-back-pain-and-modic-changes-the-aim-study-study-protocol-for-a-randomised-controlled-trial
#19
Kjersti Storheim, Ansgar Espeland, Lars Grøvle, Jan Sture Skouen, Jörg Aßmus, Audny Anke, Anne Froholdt, Linda M Pedersen, Anne Julsrud Haugen, Terese Fors, Elina Schistad, Olav Lutro, Gunn Hege Marchand, Thomas Kadar, Nils Vetti, Sigrun Randen, Øystein Petter Nygaard, Jens Ivar Brox, Margreth Grotle, John-Anker Zwart
BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers...
December 15, 2017: Trials
https://www.readbyqxmd.com/read/29237427/clinical-applications-and-effectiveness-of-guided-implant-surgery-a-critical-review-based-on-randomized-controlled-trials
#20
Marco Colombo, Carlo Mangano, Eitan Mijiritsky, Mischa Krebs, Uli Hauschild, Thomas Fortin
BACKGROUND: Nowadays implant placement protocols are widespread among clinicians all over the world. However, available literature, only partially analyses what can be potential benefits for the clinicians and patients, often focusing just on specific aspects, such as accuracy. The purpose of this review is to compare computer guided implant placement with conventional treatment protocols. METHODS: A search strategy according to the P-I-C-O format was developed and executed using an electronic MEDLINE plus manual search from 2000 up to December 2016...
December 13, 2017: BMC Oral Health
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