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Enriched trial design

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https://www.readbyqxmd.com/read/27899529/short-term-effects-of-trans-fatty-acids-from-ruminant-and-industrial-sources-on-surrogate-markers-of-cardiovascular-risk-in-healthy-men-and-women-a-randomized-controlled-double-blind-trial
#1
Thomas Radtke, Alexandra Schmid, Anja Trepp, Frieda Dähler, Michael Coslovsky, Prisca Eser, Matthias Wilhelm, Hugo Saner
OBJECTIVE: The aim of this study was to determine short-term effects of trans fatty acid (TFA) intake from ruminant and industrial sources on surrogate markers of cardiovascular risk in the context of a balanced diet with 30-36% of daily energy from fat. DESIGN: Prospective, randomized, double-blind, parallel-design study. METHODS: In this study, 142 healthy volunteers aged 45 to 69 years were randomly allocated to three different diets: either a diet enriched with 2% of daily energy intake from ruminant TFA (rTFA) or with industrial TFA (iTFA), or a diet without TFA (wTFA), for a duration of four weeks...
November 29, 2016: European Journal of Preventive Cardiology
https://www.readbyqxmd.com/read/27895297/power-of-an-adaptive-trial-design-for-endovascular-stroke-studies-simulations-using-ims-interventional-management-of-stroke-iii-data
#2
Maarten G Lansberg, Ninad S Bhat, Sharon D Yeatts, Yuko Y Palesch, Joseph P Broderick, Gregory W Albers, Tze L Lai, Philip W Lavori
BACKGROUND AND PURPOSE: Adaptive trial designs that allow enrichment of the study population through subgroup selection can increase the chance of a positive trial when there is a differential treatment effect among patient subgroups. The goal of this study is to illustrate the potential benefit of adaptive subgroup selection in endovascular stroke studies. METHODS: We simulated the performance of a trial design with adaptive subgroup selection and compared it with that of a traditional design...
December 2016: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/27893485/peripheral-neuropathic-pain-a-mechanism-related-organizing-principle-based-on-sensory-profiles
#3
Ralf Baron, Christoph Maier, Nadine Attal, Andreas Binder, Didier Bouhassira, Giorgio Cruccu, Nanna B Finnerup, Maija Haanpää, Per Hansson, Philipp Hüllemann, Troels S Jensen, Rainer Freynhagen, Jeffrey D Kennedy, Walter Magerl, Tina Mainka, Maren Reimer, Andrew S C Rice, Märta Segerdahl, Jordi Serra, Sören Sindrup, Claudia Sommer, Thomas Tölle, Jan Vollert, Rolf-Detlef Treede
Patients with neuropathic pain are heterogeneous in etiology, pathophysiology and clinical appearance. They exhibit a variety of pain-related sensory symptoms and signs (sensory profile). Different sensory profiles might indicate different classes of neurobiological mechanisms and hence subgroups with different sensory profiles might respond differently to treatment.The aim of the investigation was to identify subgroups in a large sample of neuropathic pain patients using hypothesis-free statistical methods on the database of three large multi-national research networks (German Research Network on Neuropathic Pain (DFNS), IMI-Europain, Neuropain)...
November 3, 2016: Pain
https://www.readbyqxmd.com/read/27862920/alternative-designs-for-clinical-trials-in-rare-diseases
#4
Lusine Abrahamyan, Brian M Feldman, George Tomlinson, Marie E Faughnan, Sindhu R Johnson, Ivan R Diamond, Samir Gupta
Evidence-based medicine requires strong scientific evidence upon which to base treatment. In rare diseases, study populations are often small, and thus this evidence is difficult to accrue. Investigators, though, should be creative and develop a flexible toolkit of methods to deal with the problems inherent in the study of rare disease. This narrative review presents alternative clinical trial designs for studying treatments of rare diseases, including cross-over and n-of-1 trials, randomized placebo-phase design, enriched enrollment, randomized withdrawal design, and classes of adaptive designs...
November 14, 2016: American Journal of Medical Genetics. Part C, Seminars in Medical Genetics
https://www.readbyqxmd.com/read/27861362/effects-of-target-controlled-infusion-of-high-dose-naloxone-on-pain-and-hyperalgesia-in-a-human-thermal-injury-model-a-study-protocol-a-randomized-double-blind-placebo-controlled-crossover-trial-with-an-enriched-design
#5
Anders D Springborg, Elisabeth K Jensen, Bradley K Taylor, Mads U Werner
Mu-opioid-receptor antagonists have been extensively studied in experimental research as pharmacological tools uncovering mechanisms of pain modulation by the endogenous opioid system. In rodents, administration of high doses of mu-opioid-receptor antagonists after the resolution of an inflammatory injury has demonstrated reinstatement of nociceptive hypersensitivity indicating unmasking of latent sensitization. In a recent human study, pain hypersensitivity assessed as secondary hyperalgesia area (SHA), was reinstated 7 days after a mild thermal injury, in 4 out of 12 subjects after a naloxone infusion...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27858251/methodological-issues-in-clinical-trials-of-polycystic-kidney-disease-a-focused-review
#6
REVIEW
Ioan-Andrei Iliuta, Abhijat Kitchlu, York Pei
The field of therapeutics in autosomal dominant polycystic kidney disease (ADPKD) has seen a significant expansion recently, as major clinical trials have provided promising evidence in favor of new disease-modifying drugs. Though these trials are encouraging, limitations are noticeable in the form of methodological issues that restrict the interpretation of results. In this review, we discuss the methodological pitfalls of high-profile clinical interventional trials for ADPKD which have been published since 2009...
November 17, 2016: Journal of Nephrology
https://www.readbyqxmd.com/read/27856273/hypermutation-in-pancreatic-cancer
#7
Jeremy L Humphris, Ann-Marie Patch, Katia Nones, Peter J Bailey, Amber L Johns, Skye McKay, David K Chang, David K Miller, Marina Pajic, Karin S Kassahn, Michael C J Quinn, Timothy J C Bruxner, Angelika N Christ, Ivon Harliwong, Senel Idrisoglu, Suzanne Manning, Craig Nourse, Ehsan Nourbakhsh, Andrew Stone, Peter J Wilson, Matthew Anderson, J Lynn Fink, Oliver Holmes, Stephen Kazakoff, Conrad Leonard, Felicity Newell, Nick Waddell, Scott Wood, Ronald S Mead, Qinying Xu, Jianmin Wu, Mark Pinese, Mark J Cowley, Marc D Jones, Adnan M Nagrial, Venessa T Chin, Lorraine A Chantrill, Amanda Mawson, Angela Chou, Christopher J Scarlett, Andreia V Pinho, Ilse Rooman, Marc Giry-Laterriere, Jaswinder S Samra, James G Kench, Neil D Merrett, Christopher W Toon, Krishna Epari, Nam Q Nguyen, Andrew Barbour, Nikolajs Zeps, Nigel B Jamieson, Colin J McKay, C Ross Carter, Euan J Dickson, Janet S Graham, Fraser Duthie, Karin Oien, Jane Hair, Jennifer P Morton, Owen J Sansom, Robert Grützmann, Ralph H Hruban, Anirban Maitra, Christine A Iacobuzio-Donahue, Richard D Schulick, Christopher L Wolfgang, Richard A Morgan, Rita T Lawlor, Borislav Rusev, Vincenzo Corbo, Roberto Salvia, Ivana Cataldo, Giampaolo Tortora, Margaret A Tempero, Oliver Hofmann, James R Eshleman, Christian Pilarsky, Aldo Scarpa, Elizabeth A Musgrove, Anthony J Gill, John V Pearson, Sean M Grimmond, Nicola Waddell, Andrew V Biankin
Pancreatic cancer is molecularly diverse, with few effective therapies. Increased mutation burden and defective DNA repair are associated with response to immune checkpoint inhibitors in several other cancer types. We interrogated 385 pancreatic cancer genomes to define hypermutation and its causes. Mutational signatures inferring defects in DNA repair were enriched in those with the highest mutation burdens. Mismatch repair deficiency was identified in 1% of tumors harboring different mechanisms of somatic inactivation of MLH1 and MSH2...
November 15, 2016: Gastroenterology
https://www.readbyqxmd.com/read/27852613/vitamin-c-enriched-gelatin-supplementation-before-intermittent-activity-augments-collagen-synthesis
#8
Gregory Shaw, Ann Lee-Barthel, Megan Lr Ross, Bing Wang, Keith Baar
BACKGROUND: Musculoskeletal injuries are the most common complaint in active populations. More than 50% of all injuries in sports can be classified as sprains, strains, ruptures, or breaks of musculoskeletal tissues. Nutritional and/or exercise interventions that increase collagen synthesis and strengthen these tissues could have an important effect on injury rates. OBJECTIVE: This study was designed to determine whether gelatin supplementation could increase collagen synthesis...
November 16, 2016: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/27775814/a-subgroup-cluster-based-bayesian-adaptive-design-for-precision-medicine
#9
Wentian Guo, Yuan Ji, Daniel V T Catenacci
In precision medicine, a patient is treated with targeted therapies that are predicted to be effective based on the patient's baseline characteristics such as biomarker profiles. Oftentimes, patient subgroups are unknown and must be learned through inference using observed data. We present SCUBA, a Subgroup ClUster-based Bayesian Adaptive design aiming to fulfill two simultaneous goals in a clinical trial, 1) to treatments enrich the allocation of each subgroup of patients to their precision and desirable treatments and 2) to report multiple subgroup-treatment pairs (STPs)...
October 24, 2016: Biometrics
https://www.readbyqxmd.com/read/27774059/music-upper-limb-therapy-integrated-an-enriched-collaborative-approach-for-stroke-rehabilitation
#10
Preeti Raghavan, Daniel Geller, Nina Guerrero, Viswanath Aluru, Joseph P Eimicke, Jeanne A Teresi, Gbenga Ogedegbe, Anna Palumbo, Alan Turry
: Stroke is a leading cause of disability worldwide. It leads to a sudden and overwhelming disruption in one's physical body, and alters the stroke survivors' sense of self. Long-term recovery requires that bodily perception, social participation and sense of self are restored; this is challenging to achieve, particularly with a single intervention. However, rhythmic synchronization of movement to external stimuli facilitates sensorimotor coupling for movement recovery, enhances emotional engagement and has positive effects on interpersonal relationships...
2016: Frontiers in Human Neuroscience
https://www.readbyqxmd.com/read/27734779/-new-drugs-available-more-quickly-for-the-right-patient
#11
W Kievit, F A C Berden, J P H Drenth
Pharmaceutical companies are under increasing scrutiny because of their strategy for gaining market access and reimbursement authorisation for novel drugs. The tool most often used is that of a randomised controlled trial (RCT) in a highly selected population that has a high chance of responding on the treatment but a low chance of developing side effects. This population differs to a large extent from real-life patients, who have diverging characteristics that can influence effectiveness and safety; these include co-morbidity, age and disease severity...
2016: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/27727431/fentanyl-for-neuropathic-pain-in-adults
#12
REVIEW
Sheena Derry, Cathy Stannard, Peter Cole, Philip J Wiffen, Roger Knaggs, Dominic Aldington, R Andrew Moore
BACKGROUND: Opioid drugs, including fentanyl, are commonly used to treat neuropathic pain, and are considered effective by some professionals. Most reviews have examined all opioids together. This review sought evidence specifically for fentanyl, at any dose, and by any route of administration. Other opioids are considered in separate reviews. OBJECTIVES: To assess the analgesic efficacy of fentanyl for chronic neuropathic pain in adults, and the adverse events associated with its use in clinical trials...
October 11, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27684492/pregabalin-for-pain-in-fibromyalgia-in-adults
#13
Sheena Derry, Malene Cording, Philip J Wiffen, Simon Law, Tudor Phillips, R Andrew Moore
BACKGROUND: This review updates part of an earlier Cochrane review on 'Pregabalin for acute and chronic pain in adults' (Moore 2009), and considers only fibromyalgia pain.Antiepileptic drugs have been used in pain management since the 1960s. Pregabalin is an antiepileptic drug also used in management of chronic pain conditions, including fibromyalgia. Pain response with pregabalin is associated with major benefits for other symptoms, and improved quality of life and function in people with chronic painful conditions...
September 29, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27669823/recruitment-of-older-adults-with-type-2-diabetes-into-a-community-based-exercise-and-nutrition-randomised-controlled-trial
#14
Eliza G Miller, Caryl A Nowson, David W Dunstan, Deborah A Kerr, Vicky Solah, David Menzies, Robin M Daly
BACKGROUND: Recruitment of participants into long-term community-based lifestyle intervention trials, particularly adults with a chronic disease, is often slow and challenging. Currently there is limited data on successful recruitment strategies suitable for older adults with type 2 diabetes into community-based exercise and nutrition programs, and no information on cost estimates associated with such recruitment. The aim of this report is to describe the recruitment strategies used and the success of each approach in recruiting older adults with type 2 diabetes into a 6-month community-based exercise and nutritional supplementation randomised controlled trial (RCT)...
September 26, 2016: Trials
https://www.readbyqxmd.com/read/27642057/effects-of-exchanging-carbohydrate-or-monounsaturated-fat-with-saturated-fat-on-inflammatory-and-thrombogenic-responses-in-subjects-with-abdominal-obesity-a-randomized-controlled-trial
#15
Kim-Tiu Teng, Lin Faun Chang, Shireene Ratna Vethakkan, Kalanithi Nesaretnam, Tom A B Sanders
BACKGROUND & AIMS: Modification of the amount and type of dietary fat has diverse effects on cardiovascular risk. METHODS: We recruited 54 abdominally obese subjects to participate in a prospective cross-over design, single-blind trial comparing isocaloric 2000 kcal MUFA or carbohydrate-enriched diet with SFA-enriched diet (control). The control diet consisted of 15E% protein, 53E% carbohydrate and 32E% fat (12E% SFA, 13E% MUFA). A total of ∼7E% of MUFA or refined carbohydrate was exchanged with SFA in the MUFA-rich and carbohydrate-rich diets respectively for 6-weeks...
September 8, 2016: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/27640874/optimal-sequential-enrichment-designs-for-phase-ii-clinical-trials
#16
Yong Zang, Ying Yuan
In the early phase development of molecularly targeted agents (MTAs), a commonly encountered situation is that the MTA is expected to be more effective for a certain biomarker subgroup, say marker-positive patients, but there is no adequate evidence to show that the MTA does not work for the other subgroup, that is, marker-negative patients. After establishing that marker-positive patients benefit from the treatment, it is often of great clinical interest to determine whether the treatment benefit extends to marker-negative patients...
September 19, 2016: Statistics in Medicine
https://www.readbyqxmd.com/read/27627703/camellia-oil-enriched-diet-attenuates-oxidative-stress-and-inflammatory-markers-in-hypercholesterolemic-subjects
#17
Akkarach Bumrungpert, Patcharanee Pavadhgul, Ruchaneekorn W Kalpravidh
Camellia oil is commonly used as an adjuvant in medicine. It is rich in monounsaturated fatty acids, vitamin E, and phytochemicals. The objective of this study was to examine effects of camellia oil consumption on oxidative stress, low-density lipoprotein-cholesterol (LDL-C) oxidation, and inflammatory markers in hypercholesterolemic subjects. The study design was a randomized, single-blind controlled trial. Women with hypercholesterolemia (n = 50) were randomly divided into two groups. The treatment group (n = 25) was provided camellia oil-enriched diets and the control group (n = 25) was provided diets cooked with soybean oil three meals (45 mL oil) a day for 8 weeks...
September 2016: Journal of Medicinal Food
https://www.readbyqxmd.com/read/27610616/granulocyte-colony-stimulating-factor-and-physiotherapy-after-stroke-results-of-a-feasibility-randomised-controlled-trial-stem-cell-trial-of-recovery-enhancement-after-stroke-3-stems-3-isrctn16714730
#18
Nikola Sprigg, Rebecca O'Connor, Lisa Woodhouse, Kailash Krishnan, Timothy J England, Louise A Connell, Marion F Walker, Philip M Bath
BACKGROUND: Granulocyte-colony stimulating factor (G-CSF) mobilises endogenous haematopoietic stem cells and enhances recovery in experimental stroke. Recovery may also be dependent on an enriched environment and physical activity. G-CSF may have the potential to enhance recovery when used in combination with physiotherapy, in patients with disability late after stroke. METHODS: A pilot 2 x 2 factorial randomised (1:1) placebo-controlled trial of G-CSF (double-blind), and/or a 6 week course of physiotherapy, in 60 participants with disability (mRS >1), at least 3 months after stroke...
2016: PloS One
https://www.readbyqxmd.com/read/27598622/sequential-multiple-assignment-randomization-trials-with-enrichment-design
#19
Ying Liu, Yuanjia Wang, Donglin Zeng
Sequential multiple assignment randomization trial (SMART) is a powerful design to study Dynamic Treatment Regimes (DTRs) and allows causal comparisons of DTRs. To handle practical challenges of SMART, we propose a SMART with Enrichment (SMARTER) design, which performs stage-wise enrichment for SMART. SMARTER can improve design efficiency, shorten the recruitment period, and partially reduce trial duration to make SMART more practical with limited time and resource. Specifically, at each subsequent stage of a SMART, we enrich the study sample with new patients who have received previous stages' treatments in a naturalistic fashion without randomization, and only randomize them among the current stage treatment options...
September 6, 2016: Biometrics
https://www.readbyqxmd.com/read/27581584/inflammaging-and-skeletal-muscle-can-protein-intake-make-a-difference
#20
Dimitrios Draganidis, Leonidas G Karagounis, Ioannis Athanailidis, Athanasios Chatzinikolaou, Athanasios Z Jamurtas, Ioannis G Fatouros
Inflammaging is the chronic low-grade inflammatory state present in the elderly, characterized by increased systemic concentrations of proinflammatory cytokines. It has been shown that inflammaging increases the risk of pathologic conditions and age-related diseases, and that it also has been associated with increased skeletal muscle wasting, strength loss, and functional impairments. Experimental evidence suggests that the increased concentrations of proinflammatory cytokines and primary tumor necrosis factor α observed in chronic inflammation lead to protein degradation through proteasome activation and reduced skeletal muscle protein synthesis (MPS) via protein kinase B/Akt downregulation...
October 2016: Journal of Nutrition
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