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Randomized clinical trials

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https://www.readbyqxmd.com/read/29786957/statistical-approaches-to-adjusting-weights-for-dependent-arms-in-network-meta-analysis
#1
Yu-Xuan Su, Yu-Kang Tu
Network meta-analysis compares multiple treatments in terms of their efficacy and harm by including evidence from randomized controlled trials. Most clinical trials use parallel design, where patients are randomly allocated to different treatments and receive only one treatment. However, some trials use within person designs such as split-body, split-mouth and cross-over designs, where each patient may receive more than one treatment. Data from treatment arms within these trials are no longer independent, so the correlations between dependent arms need to be accounted for within the statistical analyses...
May 22, 2018: Research Synthesis Methods
https://www.readbyqxmd.com/read/29786830/blue-light-filtering-intraocular-lenses-iols-for-protecting-macular-health
#2
REVIEW
Laura E Downie, Ljoudmila Busija, Peter R Keller
BACKGROUND: An intraocular lens (IOL) is a synthetic lens that is surgically implanted within the eye following removal of the crystalline lens, during cataract surgery. While all modern IOLs attenuate the transmission of ultra-violet (UV) light, some IOLs, called blue-blocking or blue-light filtering IOLs, also reduce short-wavelength visible light transmission. The rationale for blue-light filtering IOLs derives primarily from cell culture and animal studies, which suggest that short-wavelength visible light can induce retinal photoxicity...
May 22, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29786535/evaluating-the-importance-of-sham-controlled-trials-in-the-investigation-of-medical-devices-in-interventional-cardiology
#3
Robert A Byrne, Davide Capodanno, Felix Mahfoud, Jean Fajadet, Stephan Windecker, Peter Jüni, Andreas Baumbach, William Wijns, Michael Haude
Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomized clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants...
May 22, 2018: EuroIntervention
https://www.readbyqxmd.com/read/29786513/randomized-clinical-trials-and-personalized-medicine-a-commentary-on-deaton-and-cartwright
#4
Nicholas J Schork
No abstract text is available yet for this article.
April 24, 2018: Social Science & Medicine
https://www.readbyqxmd.com/read/29786165/comparative-study-of-1-year-clinical-and-radiological-outcomes-using-robot-assisted-pedicle-screw-fixation-and-freehand-technique-in-posterior-lumbar-interbody-fusion-a-prospective-randomized-controlled-trial
#5
Ho-Joong Kim, Kyoung-Tak Kang, Heoung-Jae Chun, Ji Sup Hwang, Bong-Soon Chang, Choon-Ki Lee, Jin S Yeom
BACKGROUND: The purpose of this study was to compare the clinical outcome of surgery using robot-assisted posterior interbody fusion with that using freehand posterior interbody fusion in patients with degenerative spinal disease. METHODS: 78 participants with degenerative spinal disease were randomly allocated (1:1) to the minimally invasive (MIS), posterior lumbar interbody fusion (Robot-PLIF) or conventional, freehand, open-approach, posterior lumbar interbody fusion (Freehand-PLIF)...
May 22, 2018: International Journal of Medical Robotics + Computer Assisted Surgery: MRCAS
https://www.readbyqxmd.com/read/29786159/gestational-dyslipidaemia-and-adverse-birthweight-outcomes-a-systematic-review-and-meta-analysis
#6
REVIEW
J Wang, D Moore, A Subramanian, K K Cheng, K A Toulis, X Qiu, P Saravanan, M J Price, K Nirantharakumar
BACKGROUND: Low and high birthweight is known to increase the risk of acute and longer-term adverse outcomes, such as stillbirth, infant mortality, obesity, type 2 diabetes and cardiovascular diseases. Gestational dyslipidaemia is associated with a numbers of adverse birth outcomes, but evidence regarding birthweight is still inconsistent to reliably inform clinical practice and treatment recommendations. OBJECTIVE: The aim of this study was to explore the relationship between maternal gestational dyslipidaemia and neonatal health outcomes, namely, birthweight, metabolic factors and inflammatory parameters...
May 21, 2018: Obesity Reviews: An Official Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/29786144/self-initiated-use-of-topical-cannabidiol-oil-for-epidermolysis-bullosa
#7
Malcolm P Chelliah, Zachary Zinn, Phoung Khuu, Joyce M C Teng
Epidermolysis bullosa is a rare blistering skin disorder that is challenging to manage because skin fragility and repeated wound healing cause itching, pain, limited mobility, and recurrent infections. Cannabidiol, an active cannabinoid found in cannabis, is postulated to have antiinflammatory and analgesic effects. We report 3 cases of self-initiated topical cannabidiol use in patients with epidermolysis bullosa in an observational study. One patient was weaned completely off oral opioid analgesics. All 3 reported faster wound healing, less blistering, and amelioration of pain with cannabidiol use...
May 22, 2018: Pediatric Dermatology
https://www.readbyqxmd.com/read/29786128/long-term-oncologic-outcomes-of-laparoscopic-sentinel-node-navigation-surgery-in-early-gastric-cancer-a-single-center-single-arm-phase-ii-trial
#8
Do Joong Park, Young Suk Park, Sang Yong Son, Ju-Hee Lee, Hye Seung Lee, Young Soo Park, Kyoung Ho Lee, Young Hoon Kim, Kyoung Un Park, Won Woo Lee, Soyeon Ahn, Sang-Hoon Ahn, Hyung-Ho Kim
BACKGROUND: Sentinel node navigation surgery (SNNS) in early gastric cancer (EGC) is technically feasible according to previous literature, however its long-term oncologic safety has not been reported. METHODS: A single-center, single-arm, phase II trial was conducted to determine the oncologic outcomes of laparoscopic sentinel node (SN) biopsy in clinical stage T1N0M0 gastric cancer patients. Cases with positive SNs on intraoperative pathologic examination underwent conventional gastrectomy with radical lymphadenectomy (SN-positive group), whereas those with negative SNs underwent laparoendoscopic-limited gastric resections without further lymph node dissections (SN-negative group)...
May 21, 2018: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/29786126/prophylactic-central-compartment-neck-dissection-in-papillary-thyroid-cancer-and-effect-on-locoregional-recurrence
#9
David T Hughes, Jennifer E Rosen, Douglas B Evans, Elizabeth Grubbs, Tracy S Wang, Carmen C Solórzano
BACKGROUND: Prophylactic central compartment neck dissection (pCCND) in addition to total thyroidectomy (TT) includes removal of central compartment lymph nodes in the absence of clinical involvement on preoperative and intraoperative evaluation. The data regarding the influence of pCCND on oncologic outcomes and surgical complication rates is mixed and, therefore, is the focus of this analysis. METHODS: A systematic review of the literature on total thyroidectomy with prophylactic central compartment neck dissection (TT + pCCND) from January 1990 to October 2017 identified 221 abstracts of which 17 met inclusion criteria and were reviewed (1 randomized-control trial, 13 retrospective cohort studies, and 3 meta-analyses)...
May 21, 2018: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/29785673/the-impact-of-transcranial-direct-current-stimulation-tdcs-on-bipolar-depression-mania-and-euthymia-a-systematic-review-of-preliminary-data
#10
Clément Dondé, Nicholas H Neufeld, Pierre A Geoffroy
The neurobiological basis of bipolar disorders (BD) has received increased attention and several brain regions and brain circuits have been correlated with clinical symptoms. These brain regions and circuits may represent targets for neuromodulation techniques such as transcranial Direct Current Stimulation (tDCS). We systematically reviewed the literature to explore the risks and benefits of tDCS in BD and examined all mood states. Following the PRISMA guidelines, a systematic literature search using several databases was performed from April 2002 to June 2017...
May 21, 2018: Psychiatric Quarterly
https://www.readbyqxmd.com/read/29785555/folic-acid-methylfolate-for-the-treatment-of-psychopathology-in-schizophrenia-a-systematic-review-and-meta-analysis
#11
Kenji Sakuma, Shinji Matsunaga, Ikuo Nomura, Makoto Okuya, Taro Kishi, Nakao Iwata
RATIONALE: This study aims to examine whether folate/folic acid/methylfolate/folinic acid supplemented to antipsychotics (FA + AP) is beneficial in schizophrenia treatment. OBJECTIVE: We conducted a comprehensive systematic review and meta-analysis of double-blind, placebo-controlled, randomized clinical trials (RCTs) of FA + AP for schizophrenia. METHODS: The primary outcome was an improvement in total symptoms. Other outcomes were psychopathology subscales (positive, negative, general, and depressive symptoms), discontinuation due to all-cause and adverse events, and individual adverse events...
May 22, 2018: Psychopharmacology
https://www.readbyqxmd.com/read/29785265/a-randomized-controlled-trial-of-the-safety-and-efficacy-of-a-topical-gentamicin-collagen-sponge-in-diabetic-patients-with-a-mild-foot-ulcer-infection
#12
Ilker Uçkay, Benjamin Kressmann, Sébastien Di Tommaso, Marina Portela, Heba Alwan, Hubert Vuagnat, Sophie Maître, Christophe Paoli, Benjamin A Lipsky
Objectives: The initial phase of infection of a foot ulcer in a person with diabetes is often categorized as mild. Clinicians usually treat these infections with antimicrobial therapy, often applied topically. Some experts, however, believe that mild diabetic foot ulcer infections will usually heal with local wound care alone, without antimicrobial therapy or dressings. Methods: To evaluate the potential benefit of treatment with a topical antibiotic, we performed a single-center, investigator-blinded pilot study, randomizing (1:1) adult patients with a mild diabetic foot ulcer infection to treatment with a gentamicin-collagen sponge with local care versus local care alone...
2018: SAGE Open Medicine
https://www.readbyqxmd.com/read/29785255/feasibility-of-high-intensity-training-in-asthma
#13
L L Toennesen, E D Soerensen, M Hostrup, C Porsbjerg, J Bangsbo, V Backer
Background: High-intensity interval training is an effective and popular training regime but its feasibility in untrained adults with asthma is insufficiently described. Objective: The randomized controlled trial 'EFFORT Asthma' explored the effects of behavioural interventions including high-intensity interval training on clinical outcomes in nonobese sedentary adults with asthma. In this article we present a sub analysis of data aiming to evaluate if patients' pre-intervention levels of asthma control, FEV1, airway inflammation and airway hyperresponsiveness (AHR) predicted their training response to the high-intensity interval training program, measured as increase in maximal oxygen consumption (VO2 max)...
2018: European Clinical Respiratory Journal
https://www.readbyqxmd.com/read/29785237/early-onset-of-clinical-improvement-with-ixekizumab-in-a-randomized-open-label-study-of-patients-with-moderate-to-severe-plaque-psoriasis
#14
Saakshi Khattri, Orin Goldblum, Kathleen Solotkin, Yasmin Amir, Michelle S Min, Terri Ridenour, Fan Emily Yang, Mark Lebwohl
Objective: The purpose of this study was to evaluate the speed of onset of clinical response to ixekizumab (IXE) and assess the progression of visible improvement in patients with moderate-to-severe plaque psoriasis. Design: This was an interventional, randomized, open-label, Phase IIIb clinical trial. Setting: This was a single center study at the Mount Sinai School of Medicine. Participants: Twelve patients were randomized at a ratio of 1:1 to receive 80mg of ixekizumab every two (IXE Q2W) or four (IXE Q4W) weeks following a starting dose of 160mg of ixekizumab...
May 2018: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/29785146/provider-use-of-a-participatory-decision-making-style-with-youth-and-caregivers-and-satisfaction-with-pediatric-asthma-visits
#15
Betsy Sleath, Delesha M Carpenter, Imelda Coyne, Scott A Davis, Claire Hayes Watson, Ceila E Loughlin, Nacire Garcia, Daniel S Reuland, Gail E Tudor
Background: We conducted a randomized controlled trial to test the effectiveness of an asthma question prompt list with video intervention to engage the youth during clinic visits. We examined whether the intervention was associated with 1) providers including youth and caregiver inputs more into asthma treatment regimens, 2) youth and caregivers rating providers as using more of a participatory decision-making style, and 3) youth and caregivers being more satisfied with visits. Methods: English- or Spanish-speaking youth aged 11-17 years with persistent asthma and their caregivers were recruited from four pediatric clinics and randomized to the intervention or usual care groups...
2018: Patient related Outcome Measures
https://www.readbyqxmd.com/read/29785141/validity-of-a-method-for-the-self-screening-of-cardiovascular-risk
#16
María Barroso, Silvia Pérez-Fernández, M Mar Vila, M Dolors Zomeño, Ruth Martí-Lluch, Ferran Cordon, Rafel Ramos, Roberto Elosua, Irene R Degano, Montse Fitó, Carmen Cabezas, Gemma Salvador, Conxa Castell, María Grau
Background: The validity of a cardiovascular risk self-screening method was assessed. The results obtained for self-measurement of blood pressure, a point-of-care system's assessment of lipid profile and glycated hemoglobin, and a self-administered questionnaire (sex, age, diabetes, tobacco consumption) were compared with the standard screening (gold standard) conducted by a health professional. Methods: Crossover clinical trial on a population-based sample from Girona (north-eastern Spain), aged 35-74, with no cardiovascular disease at recruitment...
2018: Clinical Epidemiology
https://www.readbyqxmd.com/read/29785114/convenient-food-made-of-extruded-adzuki-bean-attenuates-inflammation-and-improves-glycemic-control-in-patients-with-type-2-diabetes-a-randomized-controlled-trial
#17
Yanping Liu, Qiyan Wang, Shanshan Li, Yanfen Yue, Yuling Ma, Guixing Ren
Objective: Extrusion is a widely used food processing technology. The aim of this study was to investigate the effects of extruded adzuki bean convenient food (EABCF) on glycemic and inflammation control in type 2 diabetes mellitus (T2DM) patients. Patients and methods: In a randomized controlled trial, 120 T2DM patients were randomly assigned to a control diet group (the low glycemic index [LGI] group, assigned the traditional diabetic low glycemic index diet) or an intervention group (the EABCF group, assigned daily consumption of EABCF)...
2018: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/29785113/acupuncture-in-migraine-prophylaxis-in-czech-patients-an-open-label-randomized-controlled-trial
#18
Frantisek Musil, Jitka Pokladnikova, Zbysek Pavelek, Bo Wang, Xin Guan, Martin Valis
Background: Adjuvant acupuncture for the symptomatic treatment of migraine reduces the frequency of headaches and may be at least similarly effective to treatment with prophylactic drugs. Methods: This article describes an open-label randomized controlled clinical trial with two groups: the intervention group (n=42) and the waiting-list control group (n=44). This study occurred at the Czech-Chinese Center for Traditional Chinese Medicine at the University Hospital Hradec Kralove between October 2015 and April 2017...
2018: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/29785101/exacerbation-recovery-patterns-in-newly-diagnosed-or-maintenance-treatment-na%C3%A3-ve-patients-with-copd-secondary-analyses-of-ticari-1-trial-data
#19
David M Mannino, Emmanuelle M Clerisme-Beaty, Joanne Franceschina, Naitee Ting, Nancy K Leidy
Background: Little is known about the recovery patterns from acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in newly diagnosed or maintenance treatment-naïve patients with COPD. This study describes the course of AECOPD in these patients at the time of treatment for the symptoms of acute respiratory tract infection (RTI). Methods: This study was a secondary analysis of data from a 12-week, randomized clinical trial (TICARI 1) testing the efficacy and safety of once-daily tiotropium 18 µg maintenance therapy versus placebo in newly diagnosed or maintenance treatment-naïve COPD patients with acute RTI symptoms for ≤7 days...
2018: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/29785045/an-initial-study-on-the-effect-of-functional-electrical-stimulation-in-erectile-dysfunction-a-randomized-controlled-trial
#20
Cristiane Carboni, Alexandre Fornari, Karoline C Bragante, Marcio A Averbeck, Patrícia Vianna da Rosa, Rodrigo Della Mea Plentz
Erectile dysfunction (ED) affects approximately 150 million men worldwide. Functional electrical stimulation (FES) therapy has shown a high regenerative capacity for smooth muscle cells and, therefore, is being increasingly adopted. FES can be a beneficial treatment option when the cause of ED is related to degeneration of cavernous smooth muscle. To evaluate the impact of FES on erectile function in men with erectile dysfunction. Twenty-two patients with ED participated in this randomized clinical trial. Participants were randomly assigned to two groups: intervention (IG) or control (CG)...
May 22, 2018: International Journal of Impotence Research
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