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Clinical trial recruitment

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https://www.readbyqxmd.com/read/29351570/joint-adolescent-adult-early-phase-clinical-trials-to-improve-access-to-new-drugs-for-adolescents-with-cancer-proposals-from-the-multi-stakeholder-platform-accelerate
#1
N Gaspar, L V Marshall, D Binner, R Herold, R Rousseau, P Blanc, R Capdeville, J Carleer, C Copland, Y Kerloeguen, K Norga, L Pacaud, M-A Sevaux, C Spadoni, J Sterba, F Ligas, T Taube, M Uttenreuther-Fischer, S Chioato, M A O'Connell, B Geoerger, J-Y Blay, J C Soria, S Kaye, B Wulff, L Brugières, G Vassal, A D J Pearson
The impressive progress recently observed in adult cancers through the introduction of new drugs has not yet been translated to adolescents between 12 and 17 years of age. Currently adolescents are grouped with children, so their access to new, effective drugs already available for adults is delayed because paediatric drug development starts late relative to adult programmes. Moreover, specific early phase trials designed exclusively for adolescents in rare diseases recruit poorly, even if conducted internationally...
January 16, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29350771/recombinant-relaxin-protects-liver-transplants-from-ischemia-damage-via-hepatocyte-glucocorticoid-receptor-from-bench-to-bedside
#2
Shoichi Kageyama, Kojiro Nakamura, Takehiro Fujii, Bibo Ke, Rebecca A Sosa, Elaine F Reed, Nakul Datta, Ali Zarrinpar, Ronald W Busuttil, Jerzy W Kupiec-Weglinski
Hepatic ischemia-reperfusion injury (IRI) represents a major risk factor of early graft dysfunction and acute/chronic rejection as well as a key obstacle to expanding the donor pool in orthotopic liver transplantation (OLT). Although glucocorticoid receptor (GR) signaling may enhance cytoprotective programs, clinical use of glucocorticoid is limited due to adverse effects, while clinical relevance of GR-facilitated cytoprotection in OLT remains unknown. We aimed to evaluate the significance of hepatic GR in clinical OLT and verify the impact of recombinant human relaxin (rhRLX), which may function as GR agonist in tissue/disease-specific manner...
January 19, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29350324/evolving-landscape-of-clinical-trials-in-heart-failure-patient-populations-endpoint-selection-and-regions-of-enrollment
#3
REVIEW
Ayman Samman Tahhan, Muthiah Vaduganathan, Stephen J Greene, Maureen Okafor, Sonali Kumar, Javed Butler
PURPOSE OF REVIEW: Clinical trial design and execution are evolving as increasingly important considerations with respect to the success of heart failure trials. The current review highlights temporal trends in characteristics of heart failure clinical trials. RECENT FINDINGS: Recent trials in heart failure have required longer recruitment phases, displayed inefficient enrollment rates, increased use of composite and nonfatal endpoints, undergone rapid globalization, and gradually increased focus on heart failure with preserved ejection fraction...
January 19, 2018: Current Heart Failure Reports
https://www.readbyqxmd.com/read/29347991/the-benefits-and-tolerance-of-exercise-in-myasthenia-gravis-mgex-study-protocol-for-a-randomised-controlled-trial
#4
Simone Birnbaum, Jean-Yves Hogrel, Raphael Porcher, Pierre Portero, Bernard Clair, Bruno Eymard, Sophie Demeret, Guillaume Bassez, Marcela Gargiulo, Estelle Louët, Sonia Berrih-Aknin, Asmaa Jobic, Philippe Aegerter, Philippe Thoumie, Tarek Sharshar
BACKGROUND: Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG...
January 18, 2018: Trials
https://www.readbyqxmd.com/read/29346409/prediction-of-absolute-risk-of-acute-graft-versus-host-disease-following-hematopoietic-cell-transplantation
#5
Catherine Lee, Sebastien Haneuse, Hai-Lin Wang, Sherri Rose, Stephen R Spellman, Michael Verneris, Katharine C Hsu, Katharina Fleischhauer, Stephanie J Lee, Reza Abdi
Allogeneic hematopoietic cell transplantation (HCT) is the treatment of choice for a variety of hematologic malignancies and disorders. Unfortunately, acute graft-versus-host disease (GVHD) is a frequent complication of HCT. While substantial research has identified clinical, genetic and proteomic risk factors for acute GVHD, few studies have sought to develop risk prediction tools that quantify absolute risk. Such tools would be useful for: optimizing donor selection; guiding GVHD prophylaxis, post-transplant treatment and monitoring strategies; and, recruitment of patients into clinical trials...
2018: PloS One
https://www.readbyqxmd.com/read/29346320/c-phycocyanin-and-phycocyanobilin-as-remyelination-therapies-for-enhancing-recovery-in-multiple-sclerosis-and-ischemic-stroke-a-preclinical-perspective
#6
REVIEW
Giselle Pentón-Rol, Javier Marín-Prida, Viviana Falcón-Cama
Myelin loss has a crucial impact on behavior disabilities associated to Multiple Sclerosis (MS) and Ischemic Stroke (IS). Although several MS therapies are approved, none of them promote remyelination in patients, limiting their ability for chronic recovery. With no available therapeutic options, enhanced demyelination in stroke survivors is correlated with a poorer behavioral recovery. Here, we show the experimental findings of our group and others supporting the remyelinating effects of C-Phycocyanin (C-PC), the main biliprotein of Spirulina platensis and its linked tetrapyrrole Phycocyanobilin (PCB), in models of these illnesses...
January 18, 2018: Behavioral Sciences
https://www.readbyqxmd.com/read/29344041/impact-of-nutrition-education-in-improving-dietary-pattern-during-pregnancy-based-on-pender-s-health-promotion-model-a-randomized-clinical-trial
#7
Masoomeh Goodarzi-Khoigani, Mohammad Hossein Baghiani Moghadam, Azadeh Nadjarzadeh, Farahnaz Mardanian, Hossein Fallahzadeh, SeyedSaeed Mazloomy-Mahmoodabad
Background: Different types of nutrients in adequate amounts are required to meet the increased demands of the mother and the developing fetus. Therefore, we examined the impact of nutrition education on the number of food servings per day. Materials and Methods: Pregnant mothers were recruited to a prospective, randomized clinical trial from May to September, 2016. At 6-10 weeks of gestation, the participants were randomly divided into the intervention (n = 96) or the control group (n = 96), and were followed-up until the end of pregnancy...
January 2018: Iranian Journal of Nursing and Midwifery Research
https://www.readbyqxmd.com/read/29343927/yoga-into-cancer-care-a-review-of-the-evidence-based-research
#8
REVIEW
Ram P Agarwal, Adi Maroko-Afek
To cope with cancer and its treatment-related side effects and toxicities, people are increasingly using complementary and alternative medicine (CAM). Consequently, integrative oncology, which combines conventional therapies and evidence-based CAM practices, is an emerging discipline in cancer care. The use of yoga as a CAM is proving to be beneficial and increasingly gaining popularity. An electronic database search (PubMed), through December 15, 2016, revealed 138 relevant clinical trials (single-armed, nonrandomized, and randomized controlled trials) on the use of yoga in cancer patients...
January 2018: International Journal of Yoga
https://www.readbyqxmd.com/read/29343468/onabotulinum-toxin-a-injections-for-sleep-bruxism-a-double-blind-placebo-controlled-study
#9
William G Ondo, Jerald H Simmons, Muhammad H Shahid, Vera Hashem, Christine Hunter, Joseph Jankovic
OBJECTIVES: To test the safety and efficacy of onabotulinum toxin-A (BoNT-A) injections into the masseter and temporalis muscles in patients with symptomatic sleep bruxism. METHODS: Participants 18 to 85 years old with clinically diagnosed sleep bruxism confirmed by polysomnography were enrolled in this randomized, placebo-controlled, 1:1, parallel-design trial with open-label extension. Participants were injected with BoNT-A 200 units (60 into each masseter and 40 into each temporalis) or placebo and were evaluated at 4 to 8 weeks after the initial treatment visit...
January 17, 2018: Neurology
https://www.readbyqxmd.com/read/29343280/pregabalin-versus-placebo-in-targeting-pro-nociceptive-mechanisms-to-prevent-chronic-pain-after-whiplash-injury-in-at-risk-individuals-a-feasibility-study-for-a-randomised-controlled-trial
#10
J Nikles, G Keijzers, G Mitchell, S Schug, R Ware, S A McLean, L Connelly, S Gibson, S F Farrell, M Sterling
BACKGROUND: Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of central sensitization is associated with poor recovery. Pregabalin's effects on central sensitization indicate the potential to prevent or modulate these processes after whiplash injury and to improve health outcomes, but this has not been investigated...
January 17, 2018: Trials
https://www.readbyqxmd.com/read/29343167/a-cluster-randomised-feasibility-trial-of-clinically-assisted-hydration-in-cancer-patients-in-the-last-days-of-life
#11
Andrew N Davies, Melanie Waghorn, Katherine Webber, Sigurd Johnsen, Jeewaka Mendis, Julia Boyle
BACKGROUND: The provision of clinically assisted hydration at the end-of-life is one of the most contentious issues in medicine. AIM: The aim of this feasibility study was to answer the question 'can a definitive (adequately powered) study be done?' DESIGN: The study was a cluster randomised trial, with sites randomised on a one-to-one basis to intervention 'A' (regular mouth care and usual other care) or intervention 'B' (clinically assisted hydration, mouth care and usual other care)...
January 1, 2018: Palliative Medicine
https://www.readbyqxmd.com/read/29342269/a-silent-epidemic-the-prevalence-incidence-and-persistence-of-mycoplasma-genitalium-among-young-asymptomatic-high-risk-women-in-the-united-states
#12
Arlene C Seña, Jeannette Y Lee, Jane Schwebke, Susan S Philip, Harold C Wiesenfeld, Anne M Rompalo, Robert L Cook, Marcia M Hobbs
Background: Mycoplasma genitalium (MG) is a sexually transmitted infection (STI) that can result in pelvic inflammatory disease and adverse pregnancy outcomes. We analyzed data collected from a prospective study of asymptomatic bacterial vaginosis (BV) to determine the natural history of MG. Methods: Women aged 15-25 years, with ≥2 STI risk factors and asymptomatic BV were recruited from 10 sites throughout the United States. Vaginal swabs were collected at enrollment, and by home-based testing every 2 months over 12 months...
January 12, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29340092/first-line-dose-dense-chemotherapy-with-docetaxel-cisplatin-folinic-acid-and-5-fluorouracil-dcf-plus-panitumumab-in-patients-with-locally-advanced-or-metastatic-cancer-of-the-stomach-or-gastroesophageal-junction-final-results-and-biomarker-analysis-from-an
#13
Gianluca Tomasello, Nicola Valeri, Michele Ghidini, Elizabeth C Smyth, Wanda Liguigli, Laura Toppo, Rodolfo Mattioli, Alessandra Curti, Jens C Hahne, Federica M Negri, Stefano Panni, Margherita Ratti, Silvia Lazzarelli, Fabiana Gerevini, Chiara Colombi, Andrea Panni, Massimo Rovatti, Leonardo Treccani, Mario Martinotti, Rodolfo Passalacqua
Background: Survival for patients with advanced gastroesophageal cancer (AGC) using standard treatment regimens is poor. EGFR overexpression is common in AGC and associated with poor prognosis. We hypothesized that increasing the dose intensity of chemotherapy and adding panitumumab could improve efficacy. Methods: HER2 negative, PS 0-1 patients, received up to 4 cycles of panitumumab 6 mg/kg d 1, docetaxel 60 mg/m2 d 1, cisplatin 50 mg/m2 d 1, l-folinic acid 100 mg/m2 d 1-2, followed by 5-FU 400 mg/m2 bolus d 1-2, and then 600 mg/m2 as a 22 h c...
December 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29337024/moderators-of-treatment-outcomes-following-telehealth-self-management-and-education-in-adults-with-multiple-sclerosis-a-secondary-analysis-of-a-randomized-controlled-trial
#14
Dawn M Ehde, Anne Arewasikporn, Kevin N Alschuler, Abbey J Hughes, Aaron P Turner
OBJECTIVE: To examine moderators of treatment effects in a randomized controlled trial comparing a telehealth self-management intervention to a telehealth MS education intervention for fatigue, pain, and mood in adults with multiple sclerosis (MS). DESIGN: Secondary analysis of a single-blind randomized controlled trial. SETTING: community. PARTICIPANTS: Adults with MS and chronic fatigue, chronic pain, and/or moderate depressive symptoms (N=163) recruited from across the United States...
January 11, 2018: Archives of Physical Medicine and Rehabilitation
https://www.readbyqxmd.com/read/29335232/smartphone-app-using-mindfulness-meditation-for-women-with-chronic-pelvic-pain-memphis-protocol-for-a-randomized-feasibility-trial
#15
Elizabeth Ball, Sian Newton, Brennan C Kahan, Gordon Forbes, Neil Wright, Clara Cantalapiedra Calvete, Harry A L Gibson, Ewelina Rogozinska, Carol Rivas, Stephanie J C Taylor, Judy Birch, Julie Dodds
BACKGROUND: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative...
January 15, 2018: JMIR Research Protocols
https://www.readbyqxmd.com/read/29335018/danggwijagyaksan-for-climacteric-syndrome-in-peri-and-postmenopausal-women-with-a-blood-deficiency-dominant-pattern-study-protocol-for-a-randomized-double-blind-placebo-controlled-pilot-trial
#16
Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, Ojin Kwon, Joo-Hee Kim, Eun-Ji Park, Seon-Eun Baek, Jeong-Eun Yoo, Jun-Hwan Lee
BACKGROUND: This study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion...
January 15, 2018: Trials
https://www.readbyqxmd.com/read/29334992/the-efficacy-of-a-multimodal-physical-activity-intervention-with-supervised-exercises-health-coaching-and-an-activity-monitor-on-physical-activity-levels-of-patients-with-chronic-nonspecific-low-back-pain-physical-activity-for-back-pain-payback-trial-study
#17
Crystian B Oliveira, Márcia R Franco, Chris G Maher, Anne Tiedemann, Fernanda G Silva, Tatiana M Damato, Michael K Nicholas, Diego G D Christofaro, Rafael Z Pinto
BACKGROUND: Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time...
January 15, 2018: Trials
https://www.readbyqxmd.com/read/29334921/a-pilot-feasibility-randomised-controlled-trial-of-an-adjunct-brief-social-network-intervention-in-opiate-substitution-treatment-services
#18
Ed Day, Alex Copello, Jennifer L Seddon, Marilyn Christie, Deborah Bamber, Charlotte Powell, Carmel Bennett, Shabana Akhtar, Sanju George, Andrew Ball, Emma Frew, Ilias Goranitis, Nick Freemantle
BACKGROUND: Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST. METHODS: A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT) + TAU, or 3) Personal Goal Setting (PGS) + TAU...
January 15, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29333870/the-effects-of-aerobic-exercise-for-persons-with-migraine-and-co-existing-tension-type-headache-and-neck-pain-a-randomized-controlled-clinical-trial
#19
Lotte Skytte Krøll, Catharina Sjödahl Hammarlund, Mattias Linde, Gunvor Gard, Rigmor Højland Jensen
Aim To evaluate aerobic exercise in migraine and co-existing tension-type headache and neck pain. Methods Consecutively recruited persons with migraine and co-existing tension-type headache and neck pain were randomized into an exercise group or control group. Aerobic exercise consisted of bike/cross-trainer/brisk walking for 45 minutes, three times/week. Controls continued usual daily activities. Pain frequency, intensity, and duration; physical fitness, level of physical activity, well-being and ability to engage in daily activities were assessed at baseline, after treatment and at follow-up...
January 1, 2018: Cephalalgia: An International Journal of Headache
https://www.readbyqxmd.com/read/29332633/impact-of-psychological-factors-on-the-health-related-quality-of-life-of-patients-treated-for-pulmonary-arterial-hypertension
#20
Laurence Halimi, Grégory Marin, Nicolas Molinari, Anne-Sophie Gamez, Clément Boissin, Carey M Suehs, Isabelle Vachier, Arnaud Bourdin
OBJECTIVE: Pulmonary arterial hypertension (PAH) is a rare and life-threatening disease well-marked by under diagnosis, delayed diagnosis and atypical treatments. Few data are available on the quality of life (QoL) and psychosocial characteristics of patients with PAH. Our aim is to describe the impact of psychological factors on the health-related quality of life (HRQoL) of treated PAH patients in a cross-sectional study. METHODS: Consecutive patients presenting at our Competency Centre for PAH were recruited...
February 2018: Journal of Psychosomatic Research
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