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adaptive clinical trials

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https://www.readbyqxmd.com/read/28213595/qualitative-study-of-the-breather-trial-short-cycle-antiretroviral-therapy-is-it-acceptable-to-young-people-living-with-hiv
#1
Sarah Bernays, Sara Paparini, Janet Seeley, Stella Namukwaya Kihika, Diana Gibb, Tim Rhodes
OBJECTIVES: A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8-24) living with HIV with viral load <50 c/mL to examine adaptation, acceptability and experience of SCT to inform intervention development. SETTING: Paediatric HIV clinics in the UK (2), Ireland (1), the USA (1) and Uganda (1)...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28208174/feasibility-assessment-of-patient-reporting-of-symptomatic-adverse-events-in-multicenter-cancer-clinical-trials
#2
Ethan Basch, Amylou C Dueck, Lauren J Rogak, Lori M Minasian, William Kevin Kelly, Ann M O'Mara, Andrea M Denicoff, Drew Seisler, Pamela J Atherton, Electra Paskett, Lisa Carey, Maura Dickler, Rebecca S Heist, Andrew Himelstein, Hope S Rugo, William M Sikov, Mark A Socinski, Alan P Venook, Douglas J Weckstein, Diana E Lake, David D Biggs, Rachel A Freedman, Charles Kuzma, Jeffrey J Kirshner, Deborah Schrag
Importance: In cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reported by investigators rather than by patients. There is increasing interest to collect symptomatic AE data via patient-reported outcome (PRO) questionnaires, but it is unclear whether it is feasible to implement this approach in multicenter trials. Objective: To examine whether patients are willing and able to report their symptomatic AEs in multicenter trials. Design, Setting, and Participants: A total of 361 consecutive patients enrolled in any 1 of 9 US multicenter cancer treatment trials were invited to self-report 13 common symptomatic AEs using a PRO adaptation of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) via tablet computers at 5 successive clinic visits...
February 16, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28206799/military-service-member-and-veteran-reintegration-a-critical-review-and-adapted-ecological-model
#3
Christine A Elnitsky, Cara L Blevins, Michael P Fisher, Kathryn Magruder
Returning military service members and veterans (MSMVs) experience a wide range of stress-related disorders in addition to social and occupational difficulties when reintegrating to the community. Facilitating reintegration of MSMVs following deployment is a societal priority. With an objective of identifying challenges and facilitators for reintegration of MSMVs of the current war era, we critically review and identify gaps in the literature. We searched 8 electronic databases and identified 1,764 articles...
2017: American Journal of Orthopsychiatry
https://www.readbyqxmd.com/read/28206673/the-immune-system-as-a-new-possible-cell-target-for-afp-464-in-a-spontaneous-mammary-cancer-mouse-model
#4
Mariana A Callero, Cristina E Rodriguez, Aldana Sólimo, Elisa Bal de Kier Joffé, Andrea I Loaiza Perez
Aminoflavone (AFP 464, NSC 710464), an antitumor agent which recently entered phase II clinical trials, acts against estrogen-positive breast cancer (ER +). AFP 464, which has a unique mechanism of action by activating aryl hydrocarbon receptor (AhR) signaling pathway, decreased tumor size and growth rate in the estrogen dependent, Tamoxifen-sensitive spontaneous M05 mouse model. Considering that AhR has recently emerged as a physiological regulator of the innate and adaptive immune responses, we investigated whether AFP 464 modulates the immune response in our mouse model...
February 16, 2017: Journal of Cellular Biochemistry
https://www.readbyqxmd.com/read/28202911/what-rheumatologists-need-to-know-about-crispr-cas9
#5
REVIEW
Gary J Gibson, Maozhou Yang
CRISPR/Cas9 genome editing technology has taken the research world by storm since its use in eukaryotes was first proposed in 2012. Publications describing advances in technology and new applications have continued at an unrelenting pace since that time. In this Review, we discuss the application of CRISPR/Cas9 for creating gene mutations - the application that initiated the current avalanche of interest - and new developments that have largely answered initial concerns about its specificity and ability to introduce new gene sequences...
February 9, 2017: Nature Reviews. Rheumatology
https://www.readbyqxmd.com/read/28202786/dopamine-modulates-adaptive-prediction-error-coding-in-the-human-midbrain-and-striatum
#6
Kelly M J Diederen, Hisham Ziauddeen, Martin D Vestergaard, Tom Spencer, Wolfram Schultz, Paul C Fletcher
Learning to optimally predict rewards requires agents to account for fluctuations in reward value. Recent work suggests that individuals can efficiently learn about variable rewards through adaptation of the learning rate, and coding of prediction errors relative to reward variability. Such adaptive coding has been linked to midbrain dopamine neurons in nonhuman primates, and evidence in support for a similar role of the dopaminergic system in humans is emerging from fMRI data. Here, we sought to investigate the effect of dopaminergic perturbations on adaptive prediction error coding in humans, using a between-subject, placebo-controlled pharmacological fMRI study with a dopaminergic agonist (bromocriptine) and antagonist (sulpiride)...
February 15, 2017: Journal of Neuroscience: the Official Journal of the Society for Neuroscience
https://www.readbyqxmd.com/read/28202353/the-potential-clinical-promise-of-multimodality-metronomic-chemotherapy-revealed-by-preclinical-studies-of-metastatic-disease
#7
Robert S Kerbel, Yuval Shaked
We present a rationale for further clinical development and assessment of metronomic chemotherapy on the basis of unexpected results obtained in translational mouse models of cancer involving treatment of advanced metastatic disease. Historically, mouse cancer therapy models have been dominated by treating established primary tumors or early stage low volume microscopic disease. Treatment of primary tumors is also almost always the case when using genetically engineered mouse models (GEMMS) of cancer or patient-derived xenografts (PDXs)...
February 12, 2017: Cancer Letters
https://www.readbyqxmd.com/read/28197718/adaptation-of-the-osteoarthritis-specific-quality-of-life-scale-the-oaqol-for-use-in-germany-hungary-italy-spain-and-turkey
#8
Jeanette Wilburn, Stephen P McKenna, Şehim Kutlay, Tamas Bender, Jürgen Braun, Concepcion Castillo-Gallego, Marta Favero, Pal Geher, Uta Kiltz, Emilio Martin-Mola, Roberta Ramonda, Matthew Rouse, Alan Tennant, Ayşe A Küçükdeveci
The Osteoarthritis Quality of Life scale (OAQoL) is specific to individuals with osteoarthritis. The present study describes the adaptation of the OAQoL for use in the following five European languages: German, Hungarian, Italian, Spanish and Turkish. The study involved three stages in each language; translation, cognitive debriefing (face and content validity) and validation. The validation stage assessed internal consistency (Cronbach's alpha), reproducibility (test-retest reliability using Spearman's rank correlations), convergent and divergent validity (correlations with the Health Assessment Questionnaire, The Western Ontario and McMaster Universities Index of osteoarthritis and Nottingham Health Profile) and known group validity...
February 15, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28197205/from-pathogenesis-clinical-manifestation-and-diagnosis-to-treatment-an-overview-on-autoimmune-pancreatitis
#9
REVIEW
Ou Cai, Shiyun Tan
Autoimmune pancreatitis (AIP) is a special type of chronic pancreatitis which is autoimmune mediated. The international consensus diagnostic criteria (ICDC) 2011 proposed two types of AIP: type I is associated with histological pattern of lymphoplasmacytic sclerosing pancreatitis (LPSP), characterized by serum IgG4 elevation, whereas type 2 is named idiopathic duct-centric pancreatitis (IDCP), with granulocytic epithelial lesion (GEL) and immunoglobulin G4 (IgG4) negative. The pathogenic mechanism is unclear now; based on genetic factors, disease specific or related antigens, innate and adaptive immunity may be involved...
2017: Gastroenterology Research and Practice
https://www.readbyqxmd.com/read/28193189/assessment-of-dha-on-reducing-early-preterm-birth-the-adore-randomized-controlled-trial-protocol
#10
Susan E Carlson, Byron J Gajewski, Christina J Valentine, Lynette K Rogers, Carl P Weiner, Emily A DeFranco, Catalin S Buhimschi
BACKGROUND: Preterm birth contributes to 0.5 million deliveries in the United States (one of eight pregnancies) and poses a huge burden on public health with costs in the billions. Of particular concern is that the rate of earliest preterm birth (<34 weeks) (ePTB), which has decreased little since 1990 and has the greatest impact on the overall infant mortality, resulting in the greatest cost to society. Docosahexaenoic acid (DHA) supplementation provides a potential high yield, low risk strategy to reduce early preterm delivery in the US by up to 75%...
February 13, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28193170/generating-evidence-on-a-risk-based-monitoring-approach-in-the-academic-setting-lessons-learned
#11
Belinda von Niederhäusern, Annette Orleth, Sabine Schädelin, Nawal Rawi, Martin Velkopolszky, Claudia Becherer, Pascal Benkert, Priya Satalkar, Matthias Briel, Christiane Pauli-Magnus
BACKGROUND: In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution. METHODS: We selected all studies monitored by the Clinical Trial Unit (CTU) according to Risk ADApted MONitoring (ADAMON) at the University Hospital Basel, Switzerland, between 01...
February 14, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28193121/minimal-clinically-important-differences-for-american-orthopaedic-foot-ankle-society-score-in-hallux-valgus-surgery
#12
Hiok Yang Chan, Jerry Yongqiang Chen, Suraya Zainul-Abidin, Hao Ying, Kevin Koo, Inderjeet Singh Rikhraj
BACKGROUND: The American Orthopaedic Foot & Ankle Society (AOFAS) score is one of the most common and adapted outcome scales in hallux valgus surgery. However, AOFAS is predominantly physician based and not patient based. Although it may be straightforward to derive statistical significance, it may not equate to the true subjective benefit of the patient's experience. There is a paucity of literature defining MCID for AOFAS in hallux valgus surgery although it could have a great impact on the accuracy of analyzing surgical outcomes...
February 1, 2017: Foot & Ankle International
https://www.readbyqxmd.com/read/28187284/clonal-heterogeneity-and-tumor-evolution-past-present-and-the-future
#13
REVIEW
Nicholas McGranahan, Charles Swanton
Intratumor heterogeneity, which fosters tumor evolution, is a key challenge in cancer medicine. Here, we review data and technologies that have revealed intra-tumor heterogeneity across cancer types and the dynamics, constraints, and contingencies inherent to tumor evolution. We emphasize the importance of macro-evolutionary leaps, often involving large-scale chromosomal alterations, in driving tumor evolution and metastasis and consider the role of the tumor microenvironment in engendering heterogeneity and drug resistance...
February 9, 2017: Cell
https://www.readbyqxmd.com/read/28183213/the-ottawa-panel-clinical-practice-guidelines-for-the-management-of-knee-osteoarthritis-part-two-strengthening-exercise-programs
#14
Lucie Brosseau, Jade Taki, Brigit Desjardins, Odette Thevenot, Marlene Fransen, George A Wells, Aline Mizusaki Imoto, Karine Toupin-April, Marie Westby, Inmaculada C Álvarez Gallardo, Wendy Gifford, Lucie Laferrière, Prinon Rahman, Laurianne Loew, Gino De Angelis, Sabrina Cavallo, Shirin Mehdi Shallwani, Ala' Aburub, Kim L Bennell, Martin Van der Esch, Milena Simic, Sara McConnell, Alison Harmer, Glen P Kenny, Gail Paterson, Jean-Philippe Regnaux, Marie-Martine Lefevre-Colau, Linda McLean
OBJECTIVE: To identify effective strengthening exercise programs and provide rehabilitation teams and patients with updated, high-quality recommendations concerning traditional land-based exercises for knee osteoarthritis. METHODS: A systematic search and adapted selection criteria included comparative controlled trials with strengthening exercise programs for patients with knee osteoarthritis. A panel of experts reached consensus on the recommendations using a Delphi survey...
February 1, 2017: Clinical Rehabilitation
https://www.readbyqxmd.com/read/28183194/the-ottawa-panel-clinical-practice-guidelines-for-the-management-of-knee-osteoarthritis-part-three-aerobic-exercise-programs
#15
Lucie Brosseau, Jade Taki, Brigit Desjardins, Odette Thevenot, Marlene Fransen, George A Wells, Aline Mizusaki Imoto, Karine Toupin-April, Marie Westby, Inmaculada C Álvarez Gallardo, Wendy Gifford, Lucie Laferrière, Prinon Rahman, Laurianne Loew, Gino De Angelis, Sabrina Cavallo, Shirin Mehdi Shallwani, Ala' Aburub, Kim L Bennell, Martin Van der Esch, Milena Simic, Sara McConnell, Alison Harmer, Glen P Kenny, Gail Paterson, Jean-Philippe Regnaux, Marie-Martine Lefevre-Colau, Linda McLean
OBJECTIVES: To identify effective aerobic exercise programs and provide clinicians and patients with updated, high-quality recommendations concerning traditional land-based exercises for knee osteoarthritis. METHODS: A systematic search and adapted selection criteria included comparative controlled trials with strengthening exercise programs for patients with knee osteoarthritis. A panel of experts reached consensus on the recommendations using a Delphi survey. A hierarchical alphabetical grading system (A, B, C+, C, D, D+, or D-) was used, based on statistical significance ( P < 0...
February 1, 2017: Clinical Rehabilitation
https://www.readbyqxmd.com/read/28183188/the-ottawa-panel-clinical-practice-guidelines-for-the-management-of-knee-osteoarthritis-part-one-introduction-and-mind-body-exercise-programs
#16
Lucie Brosseau, Jade Taki, Brigit Desjardins, Odette Thevenot, Marlene Fransen, George A Wells, Aline Mizusaki Imoto, Karine Toupin-April, Marie Westby, Inmaculada C Álvarez Gallardo, Wendy Gifford, Lucie Laferrière, Prinon Rahman, Laurianne Loew, Gino De Angelis, Sabrina Cavallo, Shirin Mehdi Shallwani, Ala' Aburub, Kim L Bennell, Martin Van der Esch, Milena Simic, Sara McConnell, Alison Harmer, Glen P Kenny, Gail Paterson, Jean-Philippe Regnaux, Marie-Martine Lefevre-Colau, Linda McLean
OBJECTIVE: To identify effective mind-body exercise programs and provide clinicians and patients with updated, high-quality recommendations concerning non-traditional land-based exercises for knee osteoarthritis. METHODS: A systematic search and adapted selection criteria included comparative controlled trials with mind-body exercise programs for patients with knee osteoarthritis. A panel of experts reached consensus on the recommendations using a Delphi survey...
January 1, 2017: Clinical Rehabilitation
https://www.readbyqxmd.com/read/28178876/designing-fecal-microbiota-transplant-trials-that-account-for-differences-in-donor-stool-efficacy
#17
Scott W Olesen, Thomas Gurry, Eric J Alm
Fecal microbiota transplantation is a highly effective intervention for patients suffering from recurrent Clostridium difficile, a common hospital-acquired infection. Fecal microbiota transplantation's success as a therapy for C. difficile has inspired interest in performing clinical trials that experiment with fecal microbiota transplantation as a therapy for other conditions like inflammatory bowel disease, obesity, diabetes, and Parkinson's disease. Results from clinical trials that use fecal microbiota transplantation to treat inflammatory bowel disease suggest that, for at least one condition beyond C...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28178849/adaptive-designs-from-a-data-safety-monitoring-board-perspective-some-controversies-and-some-case-studies
#18
Bruce W Turnbull
This article describes vignettes concerning interactions with Data Safety Monitoring Boards during the design and monitoring of some clinical trials with an adaptive design. Most reflect personal experiences by the author.
February 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/28173784/a-protocol-for-a-new-methodological-model-for-work-related-shoulder-complex-injuries-from-diagnosis-to-rehabilitation
#19
Igor Setuain, Miriam Gonzalez-Izal, Ainara Paularena, Jose Luis Luque, Lars L Andersen, Mikel Izquierdo
BACKGROUND: Work-related injuries of the shoulder complex represent a challenge for clinicians because of the large variety of clinical entities involved and the broad anatomic structures that can be affected. Furthermore, commonly performed orthopedic tests have demonstrated limited accuracy for diagnosing the injury despite considerable research efforts. The aim of this study protocol is therefore to describe a comprehensive approach integrating both a clinical- and functional status-based pathology and an adapted rehabilitation prescription...
February 7, 2017: BMC Musculoskeletal Disorders
https://www.readbyqxmd.com/read/28173775/evaluation-and-implementation-of-highly-challenging-balance-training-in-clinical-practice-for-people-with-parkinson-s-disease-protocol-for-the-hibalance-effectiveness-implementation-trial
#20
Breiffni Leavy, Lydia Kwak, Maria Hagströmer, Erika Franzén
BACKGROUND: If people with progressive neurological diseases are to avail of evidence-based rehabilitation, programs found effective in randomized controlled trials (RCT's) must firstly be adapted and tested in clinical effectiveness studies as a means of strengthening their evidence base. This paper describes the protocol for an effectiveness-implementation trial that will assess the clinical effectiveness of a highly challenging balance training program (the HiBalance program) for people with mild-moderate Parkinson's disease (PD) while simultaneously collecting data concerning the way in which the program is implemented...
February 7, 2017: BMC Neurology
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