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Randomised control trials

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https://www.readbyqxmd.com/read/28550627/association-between-antithrombotic-drug-use-before-chronic-subdural-haematoma-and-outcome-after-drainage-a-systematic-review-and-meta-analysis
#1
Michael T C Poon, Rustam Al-Shahi Salman
In view of their age and vascular co-morbidities, people are often taking an antithrombotic drug when diagnosed with chronic subdural haematoma (CSDH). It is unclear whether antithrombotic use at CSDH diagnosis, or resumption afterwards, is associated with recurrent CSDH or vaso-occlusive events. We systematically reviewed the literature for studies reporting CSDH recurrence or vaso-occlusive events after drainage of CSDH associated with antithrombotic drug use. We searched Medline 1946-2016 and Embase 1974-2016 inclusive for cohort studies reporting the risk of CSDH recurrence or vaso-occlusive events after CSDH associated with antithrombotic (anticoagulant or antiplatelet) drug use...
May 26, 2017: Neurosurgical Review
https://www.readbyqxmd.com/read/28550592/certolizumab-pegol-for-treating-rheumatoid-arthritis-following-inadequate-response-to-a-tnf-%C3%AE-inhibitor-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#2
REVIEW
Iñigo Bermejo, Matt Stevenson, Rachel Archer, John W Stevens, Edward Goka, Mark Clowes, David L Scott, Adam Young
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (UCB Pharma) of certolizumab pegol (CZP; Cimzia(®)) to submit evidence of its clinical and cost effectiveness for the treatment of rheumatoid arthritis (RA) following inadequate response to a tumour necrosis factor-α inhibitor (TNFi). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
May 26, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28550461/a-systematic-review-of-the-literature-on-cystodistension-in-bladder-pain-syndrome
#3
Louise E Olson, James E Dyer, Ahsanul Haq, Jeremy Ockrim, Tamsin J Greenwell
INTRODUCTION AND HYPOTHESIS: There is significant variability in technique for cystodistension and an international discrepancy in the role in its treatment of bladder pain syndrome (BPS). The authors evaluate the evidence base for the use of cystodistension for BPS with particular reference to patient-related outcomes. METHODS: In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement, a prospective search and evaluation protocol was prepared and registered with the PROSPERO database (ID CRD42017053710)...
May 26, 2017: International Urogynecology Journal
https://www.readbyqxmd.com/read/28550457/treatment-of-juvenile-dermatomyositis-an-update
#4
REVIEW
Charalampia Papadopoulou, Lucy R Wedderburn
The idiopathic inflammatory myopathies of childhood consist of a heterogeneous group of autoimmune diseases characterised by proximal muscle weakness and pathognomonic skin rashes. The overall prognosis of juvenile myositis has improved significantly over recent years, but the long-term outcome differs substantially from patient to patient, suggestive of distinct clinical phenotypes with variable responses to treatment. High doses of corticosteroids remain the cornerstone of therapy along with other immunosuppressant therapies depending on disease severity and response...
May 26, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28550071/tubular-discectomy-versus-conventional-microdiscectomy-for-the-treatment-of-lumbar-disc-herniation-long-term-results-of-a-randomised-controlled-trial
#5
Gijsbert M Overdevest, Wilco C Peul, Ronald Brand, Bart W Koes, Ronald Hma Bartels, Wee F Tan, Mark P Arts
BACKGROUND: The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up...
May 26, 2017: Journal of Neurology, Neurosurgery, and Psychiatry
https://www.readbyqxmd.com/read/28550023/the-super-study-protocol-for-a-randomised-controlled-trial-comparing-follicle-stimulating-hormone-and-clomiphene-citrate-for-ovarian-stimulation-in-intrauterine-insemination
#6
N A Danhof, M van Wely, Cam Koks, J Gianotten, J P de Bruin, B J Cohlen, D P van der Ham, N F Klijn, Mha van Hooff, Fjm Broekmans, K Fleischer, Cah Janssen, J M Rijn van Weert, J van Disseldorp, M Twisk, M Traas, Mfg Verberg, M J Pelinck, J Visser, Dam Perquin, DES Boks, H R Verhoeve, C F van Heteren, Bwj Mol, S Repping, F van der Veen, M H Mochtar
OBJECTIVE: To study the effectiveness of four cycles of intrauterine insemination (IUI) with ovarian stimulation (OS) by follicle-stimulating hormone (FSH) or by clomiphene citrate (CC), and adherence to strict cancellation criteria. SETTING: Randomised controlled trial among 22 secondary and tertiary fertility clinics in the Netherlands. PARTICIPANTS: 732 women from couples diagnosed with unexplained or mild male subfertility and an unfavourable prognosis according to the model of Hunault of natural conception...
May 25, 2017: BMJ Open
https://www.readbyqxmd.com/read/28550021/effects-of-continuous-positive-airway-pressure-on-neurocognitive-architecture-and-function-in-patients-with-obstructive-sleep-apnoea-study-protocol-for-a-multicentre-randomised-controlled-trial
#7
Huajun Xu, Hui Wang, Jian Guan, Hongliang Yi, Yingjun Qian, Jianyin Zou, Yunyan Xia, Yiqun Fu, Xinyi Li, Xiao Jiao, Hengye Huang, Pin Dong, Ziwei Yu, Jun Yang, Mingliang Xiang, Jiping Li, Yanqing Chen, Peihua Wang, Yizhou Sun, Yuehua Li, Xiaojian Zheng, Wei Jia, Shankai Yin
OBJECTIVES: Many clinical studies have indicated that obstructive sleep apnoea (OSA), the most common chronic sleep disorder, may affect neurocognitive function, and that treatment for continuous positive airway pressure (CPAP) has some neurocognitive protective effects against the adverse effects of OSA. However, the effects of CPAP treatment on neurocognitive architecture and function remain unclear. Therefore, this multicentre trial was designed to investigate whether and when neurocognitive architecture and function in patients with OSA can be improved by CPAP treatment and to explore the role of gut microbiota in improving neurocognitive function during treatment...
May 25, 2017: BMJ Open
https://www.readbyqxmd.com/read/28549476/comparing-motivational-self-regulatory-and-habitual-processes-in-a-computer-tailored-physical-activity-intervention-in-hospital-employees-protocol-for-the-paths-randomised-controlled-trial
#8
Dominika Kwasnicka, Corneel Vandelanotte, Amanda Rebar, Benjamin Gardner, Camille Short, Mitch Duncan, Dawn Crook, Martin S Hagger
BACKGROUND: Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals' physical activity participation and quality of life, and to reduce work-related stress and absenteeism...
May 26, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28549455/inter-act-prevention-of-pregnancy-complications-through-an-e-health-driven-interpregnancy-lifestyle-intervention-study-protocol-of-a-multicentre-randomised-controlled-trial
#9
Annick Bogaerts, Lieveke Ameye, Margriet Bijlholt, Kelly Amuli, Dorine Heynickx, Roland Devlieger
BACKGROUND: Excessive maternal pre-pregnancy and gestational weight gain are related to pregnancy- and birth outcomes. The interpregnancy time window offers a unique opportunity to intervene in order to acquire a healthy lifestyle before the start of a new pregnancy. METHODS: INTER-ACT is an e-health driven multicentre randomised controlled intervention trial targeting women at high risk of pregnancy- and birth related complications. Eligible women are recruited for the study at day 2 or 3 postpartum...
May 26, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28549445/fibrinogen-early-in-severe-trauma-study-feisty-study-protocol-for-a-randomised-controlled-trial
#10
James Winearls, Martin Wullschleger, Elizabeth Wake, Catherine Hurn, Jeremy Furyk, Glenn Ryan, Melita Trout, James Walsham, Anthony Holley, Jeremy Cohen, Megan Shuttleworth, Wayne Dyer, Gerben Keijzers, John F Fraser, Jeffrey Presneill, Don Campbell
BACKGROUND: Haemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several international trauma guidelines using either fibrinogen concentrate (FC) or cryoprecipitate (Cryo). There is limited evidence to support one product over the other with widespread geographic and institutional variation in practice. This pilot trial is the first randomised controlled trial comparing FC to Cryo in traumatic haemorrhage...
May 26, 2017: Trials
https://www.readbyqxmd.com/read/28549427/developing-an-australian-first-recovery-model-for-parents-in-victorian-mental-health-and-family-services-a-study-protocol-for-a-randomised-controlled-trial
#11
Darryl Maybery, Melinda Goodyear, Andrea Reupert, Jade Sheen, Warren Cann, Kim Dalziel, Phillip Tchernagovski, Brendan O'Hanlon, Henry von Doussa
BACKGROUND: A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This randomised controlled trial aims to (i) evaluate the effectiveness of an intervention model of recovery for parents (Let's Talk about Children) in three different mental health service sectors and (ii) examine the economic value of a larger roll out (longer term) of the parent recovery model...
May 26, 2017: BMC Psychiatry
https://www.readbyqxmd.com/read/28548301/night-to-night-variability-of-obstructive-sleep-apnea
#12
Anna S Stöberl, Esther I Schwarz, Sarah R Haile, Christopher D Turnbull, Valentina A Rossi, John R Stradling, Malcolm Kohler
One night of a sleep study is the standard for diagnosis and exclusion of obstructive sleep apnea. Single testing requires high sensitivity of the test method and a stable disease of interest to warrant a low rate of false-negative tests. Obstructive sleep apnea is diagnosed and graded by conventional thresholds of apneas and hypopneas per hour of sleep, and treatment is usually initiated in the presence of symptoms. The aim of this study was to assess night-to-night variability of obstructive sleep apnea to reassess the current practice...
May 26, 2017: Journal of Sleep Research
https://www.readbyqxmd.com/read/28548204/endovascular-treatment-for-ruptured-abdominal-aortic-aneurysm
#13
REVIEW
Stephen Badger, Rachel Forster, Paul H Blair, Peter Ellis, Frank Kee, Denis W Harkin
BACKGROUND: An abdominal aortic aneurysm (AAA) (pathological enlargement of the aorta) is a condition that can occur as a person ages. It is most commonly seen in men older than 65 years of age. Progressive aneurysm enlargement can lead to rupture and massive internal bleeding, which is fatal unless timely repair can be achieved. Despite improvements in perioperative care, mortality remains high (approximately 50%) after conventional open surgical repair. Endovascular aneurysm repair (EVAR), a minimally invasive technique, has been shown to reduce early morbidity and mortality as compared to conventional open surgery for planned AAA repair...
May 26, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28546803/effect-of-tribulus-terrestris-ginger-saffron-and-cinnamomum-on-menopausal-symptoms-a-randomised-placebo-controlled-clinical-trial
#14
Simin Taavoni, Neda Nazem Ekbatani, Hamid Haghani
Menopausal symptoms experienced by women vary widely, and while many women transition through menopause with manageable symptoms, others experience severe symptoms, which may impair their quality of life. The purpose of this study was to determine the effect of Tribulus terrestris, ginger, saffron, and Cinnamomum on menopausal symptoms. A randomised, triple-blind, controlled trial design was used for this study. The participants were 80 postmenopausal women aged 50-60 years. A demographic data form and the Menopause Rating Scale were used to collect data...
March 2017: Przeglad Menopauzalny, Menopause Review
https://www.readbyqxmd.com/read/28546268/home-based-maintenance-tele-rehabilitation-reduces-the-risk-for-acute-exacerbations-of-copd-hospitalisations-and-emergency-department-visits
#15
Maroula Vasilopoulou, Andriana I Papaioannou, Georgios Kaltsakas, Zafeiris Louvaris, Nikolaos Chynkiamis, Stavroula Spetsioti, Eleni Kortianou, Sofia Antiopi Genimata, Anastasios Palamidas, Konstantinos Kostikas, Nikolaos G Koulouris, Ioannis Vogiatzis
Pulmonary rehabilitation (PR) remains grossly underutilised by suitable patients worldwide. We investigated whether home-based maintenance tele-rehabilitation will be as effective as hospital-based maintenance rehabilitation and superior to usual care in reducing the risk for acute chronic obstructive pulmonary disease (COPD) exacerbations, hospitalisations and emergency department (ED) visits.Following completion of an initial 2-month PR programme this prospective, randomised controlled trial (between December 2013 and July 2015) compared 12 months of home-based maintenance tele-rehabilitation (n=47) with 12 months of hospital-based, outpatient, maintenance rehabilitation (n=50) and also to 12 months of usual care treatment (n=50) without initial PR...
May 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/28546260/randomised-controlled-trial-of-prolonged-treatment-in-the-remission-phase-of-anca-associated-vasculitis
#16
Alexandre Karras, Christian Pagnoux, Marion Haubitz, Kirsten de Groot, Xavier Puechal, Jan Willem Cohen Tervaert, Mårten Segelmark, Loic Guillevin, David Jayne
OBJECTIVES: A prospective randomised trial to compare two different durations of maintenance immunosuppressive therapy for the prevention of relapse in anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV). METHODS: Patients with AAV were recruited 18-24 months after diagnosis if they were in stable remission after cyclophosphamide/prednisolone-based induction followed by azathioprine/prednisolone maintenance therapy. They were randomised (1:1) to receive continued azathioprine/prednisolone to 48 months from diagnosis (continuation group) or to withdraw azathioprine/prednisolone by 24 months (withdrawal group)...
May 25, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28546236/therapeutic-effect-of-anti-il-5-on-eosinophilic-myocarditis-with-large-pericardial-effusion
#17
Tengyao Song, David Micheal Jones, Yamen Homsi
Eosinophilic myocarditis (EM) is a rare myocardial disease that results from various eosinophilic diseases, such as idiopathic hypereosinophilic syndrome, helminth infection, medications and vasculitis. Patients with EM may present with different severities, ranging from mild symptoms to a life-threatening condition. Diagnosis of EM is a challenge and requires an extensive workup, including endomyocardial biopsy. Treatment options are limited because EM is rare and there is a lack of randomised controlled trials...
May 24, 2017: BMJ Case Reports
https://www.readbyqxmd.com/read/28546097/10-years-of-denosumab-treatment-in-postmenopausal-women-with-osteoporosis-results-from-the-phase-3-randomised-freedom-trial-and-open-label-extension
#18
Henry G Bone, Rachel B Wagman, Maria L Brandi, Jacques P Brown, Roland Chapurlat, Steven R Cummings, Edward Czerwiński, Astrid Fahrleitner-Pammer, David L Kendler, Kurt Lippuner, Jean-Yves Reginster, Christian Roux, Jorge Malouf, Michelle N Bradley, Nadia S Daizadeh, Andrea Wang, Paula Dakin, Nicola Pannacciulli, David W Dempster, Socrates Papapoulos
BACKGROUND: Long-term safety and efficacy of osteoporosis treatment are important because of the chronic nature of the disease. We aimed to assess the long-term safety and efficacy of denosumab, which is widely used for the treatment of postmenopausal women with osteoporosis. METHODS: In the multicentre, randomised, double-blind, placebo-controlled, phase 3 FREEDOM trial, postmenopausal women aged 60-90 years with osteoporosis were enrolled in 214 centres in North America, Europe, Latin America, and Australasia and were randomly assigned (1:1) to receive 60 mg subcutaneous denosumab or placebo every 6 months for 3 years...
May 22, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/28546090/safety-and-tolerability-of-long-acting-cabotegravir-injections-in-hiv-uninfected-men-eclair-a-multicentre-double-blind-randomised-placebo-controlled-phase-2a-trial
#19
Martin Markowitz, Ian Frank, Robert M Grant, Kenneth H Mayer, Richard Elion, Deborah Goldstein, Chester Fisher, Magdalena E Sobieszczyk, Joel E Gallant, Hong Van Tieu, Winkler Weinberg, David A Margolis, Krischan J Hudson, Britt S Stancil, Susan L Ford, Parul Patel, Elizabeth Gould, Alex R Rinehart, Kimberly Y Smith, William R Spreen
BACKGROUND: Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when administered by injection that prevented simian-HIV infection upon repeat intrarectal challenge in male macaques. We aimed to assess the safety, tolerability, and pharmacokinetics of long-acting cabotegravir injections in healthy men not at high risk of HIV-1 infection. METHODS: We did this multicentre, double-blind, randomised, placebo-controlled, phase 2a trial at ten sites in the USA...
May 22, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28545978/benralizumab-for-patients-with-mild-to-moderate-persistent-asthma-bise-a-randomised-double-blind-placebo-controlled-phase-3-trial
#20
Gary T Ferguson, J Mark FitzGerald, Eugene R Bleecker, Michel Laviolette, David Bernstein, Craig LaForce, Lyndon Mansfield, Peter Barker, Yanping Wu, Maria Jison, Mitchell Goldman
BACKGROUND: Benralizumab is a humanised, anti-interleukin 5 receptor α monoclonal antibody that directly and rapidly depletes eosinophils, reduces asthma exacerbations, and improves lung function for patients with severe eosinophilic asthma. The objective of this trial was to assess the safety and efficacy of benralizumab for patients with mild to moderate, persistent asthma. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients aged 18-75 years, weighing at least 40 kg, and with a postbronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of at least 12% at screening, from 52 clinical research centres in six countries...
May 22, 2017: Lancet Respiratory Medicine
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