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adaptive clinical trials

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https://www.readbyqxmd.com/read/29235161/management-of-actinic-keratosis-at-specific-body-sites-in-patients-at-high-risk-of-carcinoma-lesions-expert-consensus-from-the-akteam%C3%A2-of-expert-clinicians
#1
REVIEW
M A Richard, J M Amici, N Basset-Seguin, J P Claudel, B Cribier, B Dreno
BACKGROUND: Actinic keratoses (AK) arise on sun-exposed regions of the skin. If left untreated, AK may progress to invasive squamous cell carcinoma (SCC), although the rate of progression is low. A practical treatment algorithm for the treatment of AK in standard situations has been published by the AKTeam™ expert panel. However, management of particular situations of AK with increasing/higher carcinoma risk or AK progressing into carcinomas with increased aggressiveness due to their anatomical location (risky areas), or in patients with an increased risk of SCC requires further discussion...
December 13, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/29234826/mental-health-impact-of-social-capital-interventions-a-systematic-review
#2
Elaine C Flores, Daniela C Fuhr, Angela M Bayer, Andres G Lescano, Nicki Thorogood, Victoria Simms
PURPOSE: Mental disorders are a major contributor to the global burden of disease and disability, and can be extremely costly at both individual and community level. Social capital, (SC) defined as an individual's social relationships and participation in community networks, may lower the risk of mental disorders while increasing resilience capacity, adaptation and recovery. SC interventions may be a cost-effective way of preventing and ameliorating these conditions. However, the impact of these SC interventions on mental health still needs research...
December 12, 2017: Social Psychiatry and Psychiatric Epidemiology
https://www.readbyqxmd.com/read/29234504/the-effects-of-low-intensity-blood-flow-restricted-exercise-compared-with-conventional-resistance-training-on-the-clinical-outcomes-of-active-uk-military-personnel-following-a-3-week-in-patient-rehabilitation-programme-protocol-for-a-randomized-controlled-feasibility
#3
Peter Ladlow, Russell J Coppack, Shreshth Dharm-Datta, Dean Conway, Edward Sellon, Stephen D Patterson, Alexander N Bennett
Background: A challenge for rehabilitation practitioners lies in designing optimal exercise programmes that facilitate musculoskeletal (MSK) adaptations whilst simultaneously accommodating biological healing and the safe loading of an injured limb. A growing body of evidence supports the use of resistance training at a reduced load in combination with blood flow restriction (BFR) to enhance hypertrophic and strength responses in skeletal muscle. In-patient rehabilitation has a long tradition in the UK Military, however, the efficacy of low intensity (LI) BFR training has not been tested in this rehabilitation setting...
2017: Pilot and Feasibility Studies
https://www.readbyqxmd.com/read/29233085/an-oncology-clinical-trial-design-with-randomization-adaptive-to-both-short-and-long-term-responses
#4
Hao Liu, Xiao Lin, Xuelin Huang
In oncology clinical trials, both short-term response and long-term survival are important. We propose an urn-based adaptive randomization design to incorporate both of these two outcomes. While short-term response can update the randomization probability quickly to benefit the trial participants, long-term survival outcome can also change the randomization to favor the treatment arm with definitive therapeutic benefit. Using generalized Friedman's urn, we derive an explicit formula for the limiting distribution of the number of subjects assigned to each arm...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/29228950/indacaterol-glycopyrronium-is-cost-effective-compared-to-salmeterol-fluticasone-in-copd-flame-based-modelling-in-a-swedish-population
#5
Leif Bjermer, Job F M van Boven, Madlaina Costa-Scharplatz, Dorothy L Keininger, Florian S Gutzwiller, Karin Lisspers, Ronan Mahon, Petter Olsson, Nicolas Roche
BACKGROUND: This study assessed the cost-effectiveness of indacaterol/glycopyrronium (IND/GLY) versus salmeterol/fluticasone (SFC) in chronic obstructive pulmonary disease (COPD) patients with moderate to very severe airflow limitation and ≥1 exacerbation in the preceding year. METHODS: A previously published and validated patient-level simulation model was adapted using clinical data from the FLAME trial and real-world cost data from the ARCTIC study. Costs (total monetary costs comprising drug, maintenance, exacerbation, and pneumonia costs) and health outcomes (life-years (LYs), quality-adjusted life-years (QALYs)) were projected over various time horizons (1, 5, 10 years, and lifetime) from the Swedish payer's perspective and were discounted at 3% annually...
December 11, 2017: Respiratory Research
https://www.readbyqxmd.com/read/29228756/interim-pet-ct-may-predict-pfs-and-os-in-t-all-lbl-adult-patients
#6
Liang Wang, Jing-Hua Wang, Xi-Wen Bi, Xiao-Qin Chen, Yue Lu, Zhong-Jun Xia
T lymphoblastic leukemia/lymphoma (T-ALL/LBL) is highly aggressive. Although intensive chemotherapies such as ALL-type regimens are commonly used, about half adult patients eventually relapse and die of T-ALL/LBL. Overwhelming evidences have confirmed that interim PET can predict survival outcomes and guide subsequent treatments in Hodgkin lymphoma. However, whether interim PET-CT can predict survival outcomes or not in T-ALL/LBL patients remains unclear. 47 adult patients of T-ALL/LBL were retrospectively reviewed...
November 17, 2017: Oncotarget
https://www.readbyqxmd.com/read/29225818/practical-considerations-for-iron-therapy-in-the-management-of-anaemia-in-patients-with-chronic-kidney-disease
#7
REVIEW
Simon D Roger
Clinical practice guidelines provide both local and global recommendations for the use of iron therapy in the management of anaemia in patients with chronic kidney disease. However, physicians must interpret and adapt these guidelines to meet the specific needs of their individual patients. The recommendations must also be considered in the context of findings from more recently published clinical trials and observational studies.
December 2017: Clinical Kidney Journal
https://www.readbyqxmd.com/read/29222279/follicular-lymphoma-are-we-ready-for-a-risk-adapted-approach
#8
REVIEW
Brad S Kahl
Follicular lymphoma is the most common indolent non-Hodgkin lymphoma in the Western hemisphere. The natural history of FL appears to have been favorably impacted by the introduction of rituximab after randomized clinical trials demonstrated that the addition of rituximab to standard chemotherapy induction has improved the overall survival. Yet, the disease is biologically and clinically heterogeneous with wide variations in outcomes for individual patients. The ability to accurately risk-stratify patients and then tailor therapy to the individual is an area of ongoing research...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29221893/cardioprotective-effect-of-influenza-and-pneumococcal-vaccination-in-patients-with-cardiovascular-diseases
#9
REVIEW
Andrzej Ciszewski
Due to the wide interaction between the respiratory and the circulatory systems, influenza and pneumococcal vaccinations are recommended in the prevention and treatment of cardiovascular diseases. The review summarizes the results of recent studies and meta-analyses demonstrating that in this group of high-risk patients both vaccinations have potentially beneficial properties. However, in the era of Evidence Base Medicine, there is still a lack of randomized prospective clinical trials, especially those evaluating the effect of pneumococcal vaccination...
December 5, 2017: Vaccine
https://www.readbyqxmd.com/read/29221516/transculturalizing-diabetes-prevention-in-latin-america
#10
REVIEW
Ramfis Nieto-Martínez, Juan P González-Rivas, Pablo Aschner, Noël C Barengo, Jeffrey I Mechanick
BACKGROUND: Type 2 diabetes (T2D) imposes a heavy burden in developing countries, requiring effective primary prevention policies. Randomized clinical trials have identified successful strategies in T2D prevention. However, translating these results to real-life scenarios and adapting to ethnocultural differences is a major challenge. Transculturalization allows incorporating cultural factors to diabetes prevention strategies to optimize implementation of clinical trials results. The purpose of this paper is to review the transcultural adaptations developed for T2D prevention in Latin America (LA)...
May 2017: Annals of Global Health
https://www.readbyqxmd.com/read/29220823/patterns-of-progressive-atrophy-vary-with-age-in-alzheimer-s-disease-patients
#11
Cassidy M Fiford, Gerard R Ridgway, David M Cash, Marc Modat, Jennifer Nicholas, Emily N Manning, Ian B Malone, Geert Jan Biessels, Sebastien Ourselin, Owen T Carmichael, M Jorge Cardoso, Josephine Barnes
Age is not only the greatest risk factor for Alzheimer's disease (AD) but also a key modifier of disease presentation and progression. Here, we investigate how longitudinal atrophy patterns vary with age in mild cognitive impairment (MCI) and AD. Data comprised serial longitudinal 1.5-T magnetic resonance imaging scans from 153 AD, 339 MCI, and 191 control subjects. Voxel-wise maps of longitudinal volume change were obtained and aligned across subjects. Local volume change was then modeled in terms of diagnostic group and an interaction between group and age, adjusted for total intracranial volume, white-matter hyperintensity volume, and apolipoprotein E genotype...
November 14, 2017: Neurobiology of Aging
https://www.readbyqxmd.com/read/29220291/emerging-targeted-and-immune-based-therapies-in-sarcoma
#12
Seth M Pollack, Matthew Ingham, Matthew B Spraker, Gary K Schwartz
Soft tissue and bone sarcomas are malignancies of mesenchymal origin, and more than 50 subtypes are defined. For most sarcomas, locally advanced or unresectable disease is still treated with cytotoxic chemotherapy. Recently, our understanding of subtype-specific cancer biology has expanded, and it has revealed distinct molecular alterations responsible for tumor initiation and progression. These findings have motivated the development of targeted therapies that are being evaluated in subtype-specific or biomarker-driven clinical trials...
December 8, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29218271/magnetic-resonance-imaging-in-precision-radiation-therapy-for-lung-cancer
#13
REVIEW
Hannah Bainbridge, Ahmed Salem, Rob H N Tijssen, Michael Dubec, Andreas Wetscherek, Corinne Van Es, Jose Belderbos, Corinne Faivre-Finn, Fiona McDonald
Radiotherapy remains the cornerstone of curative treatment for inoperable locally advanced lung cancer, given concomitantly with platinum-based chemotherapy. With poor overall survival, research efforts continue to explore whether integration of advanced radiation techniques will assist safe treatment intensification with the potential for improving outcomes. One advance is the integration of magnetic resonance imaging (MRI) in the treatment pathway, providing anatomical and functional information with excellent soft tissue contrast without exposure of the patient to radiation...
December 2017: Translational Lung Cancer Research
https://www.readbyqxmd.com/read/29214573/post-approval-studies-for-rare-disease-treatments-and-orphan-drugs
#14
William C Maier, Ronald A Christensen, Patricia Anderson
Drug development involves a multi-stage process of drug discovery, animal studies and human clinical trials to assess the safety and efficacy of new medications. Rare disease drug development involves a much smaller number of affected patients, a predominance of pediatric patients and more complicated disease presentation. Post-approval studies are designed to address several limitations associated with the rare disease clinical trials.National and international regulatory agencies in the US and Europe have adopted similar approaches to requirements post-approval data for rare diseases and orphan drug indications...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29213213/-from-resistance-to-challenge-child-health-service-nurses-experiences-of-how-a-course-in-group-leadership-affected-their-management-of-parental-groups
#15
Åsa Lefèvre, Pia Lundqvist, Eva Drevenhorn, Inger Hallström
Background: All parents in Sweden are invited to child health service (CHS) parental groups, however only 49% of the families participate. The way the parental groups are managed has been shown to be of importance for how parents experience the support and CHS nurses describe feeling insecure when running the groups. Lack of facilitation, structure and leadership might jeopardise the potential benefit of such support groups. This study describes CHS nurses' experiences of how a course in group leadership affected the way they ran their parental groups...
2017: BMC Nursing
https://www.readbyqxmd.com/read/29211745/the-back-belief-questionnaire-is-efficient-to-assess-false-beliefs-and-related-fear-in-low-back-pain-populations-a-transcultural-adaptation-and-validation-study
#16
Arnaud Dupeyron, Charlotte Lanhers, Sophie Bastide, Sandrine Alonso, Matthias Toulotte, Claire Jourdan, Emmanuel Coudeyre
BACKGROUND: According to the fear avoidance model, beliefs and thoughts can modify the outcome of patient with low back pain. The Back Belief Questionnaire (BBQ)-a 14 items scale-assesses these consequences of low back pain. OBJECTIVE: To test the psychometric properties of the French version of the BBQ. METHODS: The BBQ was translated using the forward-backward translation process. Throughout three repeated evaluation time points (D1, D7 and D30), various aspects of validity were analysed: acceptability, quality of items, unidimentionality, internal consistency, temporal stability (between D1 and D7), responsiveness (between D7 and D30), and construct validity comparing it to other validated scales...
2017: PloS One
https://www.readbyqxmd.com/read/29209573/trial-watch-immunogenic-cell-death-induction-by-anticancer-chemotherapeutics
#17
REVIEW
Abhishek D Garg, Sanket More, Nicole Rufo, Odeta Mece, Maria Livia Sassano, Patrizia Agostinis, Laurence Zitvogel, Guido Kroemer, Lorenzo Galluzzi
The expression "immunogenic cell death" (ICD) refers to a functionally unique form of cell death that facilitates (instead of suppressing) a T cell-dependent immune response specific for dead cell-derived antigens. ICD critically relies on the activation of adaptive responses in dying cells, culminating with the exposure or secretion of immunostimulatory molecules commonly referred to as "damage-associated molecular patterns". Only a few agents can elicit bona fide ICD, including some clinically established chemotherapeutics such as doxorubicin, epirubicin, idarubicin, mitoxantrone, bleomycin, bortezomib, cyclophosphamide and oxaliplatin...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/29208938/oncolytic-virotherapy-as-an-immunotherapeutic-strategy-for-multiple-myeloma
#18
REVIEW
Daniel E Meyers, Satbir Thakur, Chandini M Thirukkumaran, Don G Morris
Multiple Myeloma (MM), a clonal malignancy of antibody-producing plasma cells, is the second most common hematologic malignancy and results in significant patient morbidity and mortality. The high degree of immune dysregulation in MM, including T cell imbalances and up-regulation of immunosuppressive checkpoint proteins and myeloid derived suppressor cells, allows this malignancy to escape from host immune control. Despite advances in the therapeutic landscape of MM over the last decade, including the introduction of immunomodulatory drugs, the prognosis for this disease is poor, with less than 50% of patients surviving 5 years...
December 5, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/29208017/a-multisession-evaluation-of-an-adaptive-competitive-arm-rehabilitation-game
#19
Maja Goršič, Imre Cikajlo, Nika Goljar, Domen Novak
BACKGROUND: People with neurological injuries such as stroke should exercise frequently and intensely to regain their motor abilities, but are generally hindered by lack of motivation. One way to increase motivation in rehabilitation is through competitive exercises, but such exercises have only been tested in single brief sessions and usually did not adapt difficulty to the patient's abilities. METHODS: We designed a competitive arm rehabilitation game for two players that dynamically adapts its difficulty to both players' abilities...
December 6, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/29207984/individualised-radial-extracorporeal-shock-wave-therapy-reswt-for-symptomatic-calcific-shoulder-tendinopathy-a-retrospective-clinical-study
#20
Nikolaos Malliaropoulos, Dawn Thompson, Maria Meke, Debasish Pyne, Dimosthenis Alaseirlis, Henry Atkinson, Vasileios Korakakis, Heinz Lohrer
BACKGROUND: A retrospective single centre cohort analysis was performed to evaluate an individualised radial extracorporeal shock wave therapy (rESWT) protocol for treatment of symptomatic calcific shoulder tendinopathy. METHODS: 67 patients (79 Shoulders) were identified with 76 shoulders included for analysis. rESWT treatment protocol was adapted according to individual response to treatment. Variables included number of sessions, shockwave impulses, pressure and frequency...
December 6, 2017: BMC Musculoskeletal Disorders
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