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Randomized control trials

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https://www.readbyqxmd.com/read/28922786/relapse-free-survival-as-a-surrogate-for-overall-survival-in-the-evaluation-of-stage-ii-iii-melanoma-adjuvant-therapy
#1
Stefan Suciu, Alexander M M Eggermont, Paul Lorigan, John M Kirkwood, Svetomir N Markovic, Claus Garbe, David Cameron, Srividya Kotapati, Tai-Tsang Chen, Keith Wheatley, Natalie Ives, Gaetan de Schaetzen, Achmad Efendi, Marc Buyse
Background: We assessed whether relapse-free survival (RFS; time until recurrence/death) is a valid surrogate for overall survival (OS) among resected stage II-III melanoma patients through a meta-analysis of randomized controlled trials. Methods: Individual patient data (IPD) on RFS and OS were collected from 5826 patients enrolled in 11 randomized adjuvant trials comparing interferon (IFN) to observation. In addition, IPD from two studies comparing IFN and vaccination in 989 patients were included...
January 1, 2018: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28922784/low-fat-dietary-pattern-and-pancreatic-cancer-risk-in-the-women-s-health-initiative-dietary-modification-randomized-controlled-trial
#2
Li Jiao, Liang Chen, Donna L White, Lesley Tinker, Rowan T Chlebowski, Linda V Van Horn, Peter Richardson, Dorothy Lane, Haleh Sangi-Haghpeykar, Hashem B El-Serag
Background: Observational studies suggest that diet may influence pancreatic cancer risk. We investigated the effect of a low-fat dietary intervention on pancreatic cancer incidence. Methods: The Women's Health Initiative Dietary Modification (WHI-DM) trial is a randomized controlled trial conducted in 48 835 postmenopausal women age 50 to 79 years in the United States between 1993 and 1998. Women were randomly assigned to the intervention group (n = 19 541), with the goal of reducing total fat intake and increasing intake of vegetables, fruits, and grains, or to the usual diet comparison group (n = 29 294)...
January 1, 2018: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28922781/toxicity-of-extended-adjuvant-therapy-with-aromatase-inhibitors-in-early-breast-cancer-a-systematic-review-and-meta-analysis
#3
Hadar Goldvaser, Tristan A Barnes, Boštjan Šeruga, David W Cescon, Alberto Ocaña, Domen Ribnikar, Eitan Amir
Background: A number of randomized controlled trials (RCTs) have reported improvement in breast cancer outcomes from extending treatment with aromatase inhibitors (AIs) beyond the initial five years after diagnosis. However, the toxicity profile of extended AIs is uncertain. Methods: We identified RCTs that compared extended AIs to placebo or no treatment using MEDLINE and a review of abstracts from key conferences between 2013 and 2016. Odds ratios (ORs), 95% confidence intervals (CIs), absolute risks, and the number needed to harm (NNH) were computed for prespecified safety and tolerability outcomes including cardiovascular events, bone fractures, second cancers (excluding new breast cancer), treatment discontinuation for adverse events, and death without recurrence...
January 1, 2018: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/28922651/evaluating-the-effect-of-smoking-cessation-treatment-on-a-complex-dynamical-system
#4
Korkut Bekiroglu, Michael A Russell, Constantino M Lagoa, Stephanie T Lanza, Megan E Piper
OBJECTIVE: To understand the dynamic relations among tobacco withdrawal symptoms to inform the development of effective smoking cessation treatments. Dynamical system models from control engineering are introduced and utilized to evaluate complex treatment effects. We demonstrate how dynamical models can be used to examine how distinct withdrawal-related processes are related over time and how treatment influences these relations. METHOD: Intensive longitudinal data from a randomized placebo-controlled smoking cessation trial (N=1504) are used to estimate a dynamical model of withdrawal-related processes including momentary craving, negative affect, quitting self-efficacy, and cessation fatigue for each of six treatment conditions (nicotine patch, nicotine lozenge, bupropion, patch + lozenge, bupropion + lozenge, and placebo)...
August 25, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28922591/baseline-characteristics-and-early-response-at-week-1-predict-treatment-outcome-in-adolescents-with-bipolar-manic-or-mixed-episode-treated-with-olanzapine-results-from-a-3-week-randomized-placebo-controlled-trial
#5
Le Xiao, Stephen J Ganocy, Robert L Findling, Kiki Chang, Melissa P DelBello, John M Kane, Mauricio Tohen, Yu-Tao Xiang, Christoph U Correll
BACKGROUND: Early predictors of response and remission in pediatric mania are lacking, requiring further study. METHODS: This was a post hoc analysis of a 3-week, randomized, placebo-controlled trial of olanzapine conducted between November 2002 and May 2005 in 161 adolescents aged 13-17 years who were diagnosed with a DSM-IV acute manic or mixed episode of bipolar I disorder. Data from the olanzapine arm were analyzed to investigate the predictive power of early response or early nonresponse (≥25% or < 25% reduction in Young Mania Rating Scale [YMRS] score, respectively) at week 1 for ultimate response or nonresponse (≥ 50% or < 50% reduction in YMRS score, respectively) and for remission (YMRS total score ≤ 12 [standard definition] or ≤ 8 [stringent definition]) at week 3...
September 5, 2017: Journal of Clinical Psychiatry
https://www.readbyqxmd.com/read/28922519/a-cost-minimisation-analysis-of-olive-oil-versus-hyperoxygenated-fatty-acid-treatment-for-the-prevention-of-pressure-ulcers-in-primary-health-care-a-randomised-controlled-trial
#6
Inmaculada Lupiañez-Pérez, Juan Carlos Morilla-Herrera, Shakira Kaknani-Uttumchanchandani, Yolanda Lupiañez-Perez, Magdalena Cuevas-Fernandez-Gallego, Francisco Martin-Santos, Jorge Caro-Bautista, Jose Miguel Morales-Asencio
Pressure ulcers represent a major current health problem and cause an important economic impact on the health care system. Most studies on the prevention of pressure ulcers have been carried out in hospital contexts, with respect to the use of hyperoxygenated fatty acids, and to date no studies have specifically examined the use of olive oil-based treatments. AIM: To evaluate the cost of using extra virgin olive oil, rather than hyperoxygenated fatty acids, in the prevention of pressure ulcers among persons with impaired mobility and receiving home care...
September 18, 2017: Wound Repair and Regeneration
https://www.readbyqxmd.com/read/28922507/randomized-controlled-trial-evaluating-the-temporal-effects-of-high-intensity-exercise-on-learning-short-term-and-long-term-memory-and-prospective-memory
#7
Emily Frith, Eveleen Sng, Paul D Loprinzi
To examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Short-term memory included a 20-min delay assessment, with long-term memory including a 24-hour follow-up assessment...
September 18, 2017: European Journal of Neuroscience
https://www.readbyqxmd.com/read/28922338/does-the-%C3%AE-receptor-antagonist-esmolol-have-analgesic-effects-a-randomised-placebo-controlled-cross-over-study-on-healthy-volunteers-undergoing-the-cold-pressor-test
#8
Fredrik Ander, Anders Magnuson, Alex de Leon, Rebecca Ahlstrand
BACKGROUND: Esmolol may attenuate the sympathetic response to pain and reduce postoperative opioid consumption. It is not clear whether esmolol has an analgesic effect per se. OBJECTIVES: The aim of this study was to evaluate the analgesic effect of esmolol in the absence of anaesthetics and opioids. We tested the hypothesis that esmolol would reduce the maximum pain intensity perceived during the cold pressor test (CPT) by 2 points on a 0 to 10 numeric pain rating scale (NRS) compared to placebo...
September 15, 2017: European Journal of Anaesthesiology
https://www.readbyqxmd.com/read/28922311/motor-imagery-training-after-stroke-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#9
Zaqueline Fernandes Guerra, Alessandra L G Lucchetti, Giancarlo Lucchetti
BACKGROUND AND PURPOSE: A number of studies have suggested that imagery training (motor imagery [MI]) has value for improving motor function in persons with neurologic conditions. We performed a systematic review and meta-analysis to assess the available literature related to efficacy of MI in the recovery of individuals after stroke. METHODS: We searched the following databases: PubMed, Web of Knowledge, Scopus, Cochrane, and PEDro. Two reviewers independently selected clinical trials that investigated the effect of MI on outcomes commonly investigated in studies of stroke recovery...
October 2017: Journal of Neurologic Physical Therapy: JNPT
https://www.readbyqxmd.com/read/28922301/hypothermic-liver-perfusion
#10
Andrea Schlegel, Xavier Muller, Philipp Dutkowski
PURPOSE OF REVIEW: The review describes recent developments in hypothermic machine liver perfusion with a special focus on underlying protective mechanisms, and the role of this perfusion technique in high-risk donor-recipient combinations. RECENT FINDINGS: To maximize the number of transplantable donor livers, several centres are exploring new machine preservation techniques. In this context, hypothermic machine perfusion has been recently introduced into the clinical setting of human liver transplantation, and the effect of endischemic cold liver perfusion on posttransplant complications is currently under investigation in two multicentre, randomized controlled trials...
September 15, 2017: Current Opinion in Organ Transplantation
https://www.readbyqxmd.com/read/28922291/population-based-models-of-planning-for-palliative-care-in-older-people
#11
David C Currow, Jane Phillips, Meera Agar
PURPOSE OF REVIEW: Health service planning requires demographic, clinical, and health systems data and is unique to each health system. Planning for palliative care in older people must include patients and their carers. This review explores literature from the last 24 months. RECENT FINDINGS: The proportion of people living in skilled nursing facilities is increasing and many residents require quality palliative care. Simultaneously, the complexity of care for older people is also increasing...
September 16, 2017: Current Opinion in Supportive and Palliative Care
https://www.readbyqxmd.com/read/28922268/early-exercise-in-critically-ill-youth-and-children-a-preliminary-evaluation-the-weecycle-pilot-trial
#12
Karen Choong, Saif Awladthani, Adeeb Khawaji, Heather Clark, Asm Borhan, Ji Cheng, Sam Laskey, Charmaine Neu, Aimee Sarti, Lehana Thabane, Brian W Timmons, Katina Zheng, Samah Al-Harbi
OBJECTIVES: To determine the feasibility of conducting a full trial evaluating the efficacy of early mobilization using in-bed cycling as an adjunct to physiotherapy, on functional outcomes in critically ill children. DESIGN: Single center, pilot, randomized controlled trial. SETTING: Twelve-bed tertiary care, medical-surgical PICU at McMaster Children's Hospital, Hamilton, ON, Canada. PATIENTS: Children 3-17 years old who were limited to bed-rest with an expected PICU stay of at least 48 hours...
September 15, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28922255/systematic-review-and-meta-analysis-fecal-microbiota-transplantation-for-treatment-of-active-ulcerative-colitis
#13
Neeraj Narula, Zain Kassam, Yuhong Yuan, Jean-Frederic Colombel, Cyriel Ponsioen, Walter Reinisch, Paul Moayyedi
BACKGROUND: Changes in the colonic microbiota may play a role in the pathogenesis of ulcerative colitis (UC) and restoration of healthy gut microbiota may ameliorate disease. A systematic review and meta-analysis was conducted to assess fecal microbiota transplantation (FMT) as a treatment for active UC. METHODS: A literature search was conducted to identify high-quality studies of FMT as a treatment for patients with UC. The primary outcome was combined clinical remission and endoscopic remission or response...
August 23, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28922230/optimal-dose-of-perineural-dexamethasone-to-prolong-analgesia-after-brachial-plexus-blockade-a-systematic-review-and-meta-analysis
#14
Kyle Robert Kirkham, Alain Jacot-Guillarmod, Eric Albrecht
BACKGROUND: Perineural dexamethasone has gained popularity in regional anesthesia to prolong analgesia duration. However, uncertainty remains regarding the optimal perineural dose. Clarification of this characteristic is of significant importance as the administration of dexamethasone may lead to dose-dependent complications. The objective of this meta-analysis was to define the optimal perineural dexamethasone dose to prolong analgesia after brachial plexus blockade for adult patients undergoing upper limb surgery...
September 14, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28922207/sweet-sixteen-the-prospective-clinical-trials-of-john-l-cameron-md-the-clinician-scientist-from-alternate-allocation-to-randomized-controlled-trials
#15
Charles J Yeo
: The era of randomized controlled trials was ushered in by the British epidemiologist-statistician Austin Bradford Hill, with his work on the use of streptomycin in patients with tuberculosis. John L. Cameron, can be linked to 16 prospective clinical trials over his career thus far, starting with alternate-allocation trials and transitioning to prospective, randomized, placebo-controlled trials. These trials studied various topics in surgery-from pancreatitis to surgical site infections, to drain trials, a trial in Crohn disease and multiple trials in pancreatic surgery and cancer...
September 15, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28922193/update-on-second-trimester-medical-abortion
#16
Klaira Lerma, Kate A Shaw
PURPOSE OF REVIEW: To review recent literature on second trimester abortion with medical methods. RECENT FINDINGS: Across studies published in the recent past, it is apparent that women prefer shorter procedures and procedure times. Several randomized controlled trials have confirmed adding mifepristone to the second trimester medication abortion regimen results in shorter abortion intervals from first misoprostol administration to complete fetal expulsion. A study of simultaneous administration of mifepristone and misoprostol yielded shorter mean 'total' abortion times, presenting several logistical advantages...
September 15, 2017: Current Opinion in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/28922160/memantine-for-alzheimer-s-disease-an%C3%A2-updated-systematic-review-and%C3%A2-meta-analysis
#17
Taro Kishi, Shinji Matsunaga, Kazuto Oya, Ikuo Nomura, Toshikazu Ikuta, Nakao Iwata
BACKGROUND: The clinical benefit of memantine for Alzheimer's disease (AD) remains inconclusive. OBJECTIVE: We performed an updated systematic review and meta-analysis of the efficacy/safety of memantine in AD. METHODS: We included randomized trials of memantine for AD patients. Cognitive function scores (CF), behavioral disturbances scores (BD), and all-cause discontinuation were used as primary measures. Effect size based on a random-effects model was evaluated in the meta-analyses...
September 11, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28922159/can-musical-or-painting-interventions-improve-chronic-pain-mood-quality-of-life-and-cognition-in-patients-with-mild-alzheimer-s-disease-evidence-from-a-randomized-controlled-trial
#18
Elodie Pongan, Barbara Tillmann, Yohana Leveque, Béatrice Trombert, Jean Claude Getenet, Nicolas Auguste, Virginie Dauphinot, Hanane El Haouari, Malou Navez, Jean-Michel Dorey, Pierre Krolak-Salmon, Bernard Laurent, Isabelle Rouch
BACKGROUND: Among non-pharmacological therapies, musical intervention is often used for patients with Alzheimer's disease (AD) and patients presenting with chronic pain. However, their efficacy is still under debate. OBJECTIVE: Our aim was to determine the efficacy of choral singing versus painting sessions on chronic pain, mood, quality of life, and cognition in AD patients. METHODS: In this multicenter randomized controlled trial, 59 mild AD patients were randomized to a 12-week singing (SG; n = 31) or painting group (PG; n = 28)...
September 8, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28922158/tailored-and-adaptive-computerized-cognitive-training-in-older-adults-at-risk-for-dementia-a-randomized-controlled-trial
#19
Alex Bahar-Fuchs, Shannon Webb, Lauren Bartsch, Linda Clare, George Rebok, Nicolas Cherbuin, Kaarin J Anstey
BACKGROUND: Computerized Cognitive Training (CCT) has been shown to improve cognitive function in older adults with mild cognitive impairment (MCI) or mood-related neuropsychiatric symptoms (MrNPS), but many questions remain unresolved. OBJECTIVE: To evaluate the extent to which CCT benefits older adults with both MCI and MrNPS, and its effects on meta-cognitive and non-cognitive outcomes, as well as establish whether adapting difficulty levels and tailoring to individuals' profile is superior to generic training...
September 11, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28922099/the-effects-of-probiotic-supplementation-on-gene-expression-related-to-inflammation-insulin-and-lipids-in-patients-with-multiple-sclerosis-a-randomized-double-blind-placebo-controlled-trial
#20
Omid Reza Tamtaji, Ebrahim Kouchaki, Mahmoud Salami, Esmat Aghadavod, Elmira Akbari, Maryam Tajabadi-Ebrahimi, Zatollah Asemi
BACKGROUND: Limited data are available assessing the effects of probiotic supplementation on gene expression related to inflammation, insulin, and lipids in patients with multiple sclerosis (MS). OBJECTIVES: The current study was conducted to assess the effects of probiotic supplementation on gene expression related to inflammation, insulin, and lipids in patients with MS. METHODS: This randomized, double-blind, placebo-controlled clinical trial was performed among 40 patients with MS...
September 18, 2017: Journal of the American College of Nutrition
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