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Clinical trial recruitment

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https://www.readbyqxmd.com/read/28820000/novel-combination-strategies-for-enhancing-efficacy-of-immune-checkpoint-inhibitors-in-the-treatment-of-metastatic-solid-malignancies
#1
Michael J Flynn, James M G Larkin
Immune-checkpoint inhibitor (ICPI) drugs, which include antibodies against CTLA-4, PD-1 and PD-L1, have been shown to induce durable complete responses in a proportion of patients with particular efficacy demonstrated in both the first line and refractory setting in advanced NSCLC and melanoma. However, these drugs remain effective only in a minority of unselected patients. Areas covered: This review will focus on mechanisms of resistance to ICPI and underline the importance of identification of novel predictive markers of responsiveness...
August 18, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28819821/anti-pd-1-antibodies-as-a-therapeutic-strategy-in-classical-hodgkin-lymphoma
#2
REVIEW
Michael D Jain, John Kuruvilla
Classical Hodgkin lymphoma (cHL) is defined by malignant Reed-Sternberg (RS) cells that recruit non-malignant immune cells into a supportive tumour microenvironment. In cHL, this is driven, in part, by genomic alterations of the 9p24.1 locus encoding the immune checkpoint ligands PD-L1 and PD-L2. Therapeutic anti-PD-1 antibodies have been developed that competitively inhibit the interaction between PD-1 and its ligands. Clinical trials of anti-PD-1 antibodies in cHL demonstrate high overall response rates but relapses still occur and new clinical challenges exist for toxicity management and response assessment...
August 17, 2017: Drugs
https://www.readbyqxmd.com/read/28819803/if-at-first-you-don-t-succeed%C3%A2-%C3%A2-adoption-of-ipad-marking-for-high-stakes-assessments
#3
Terry Judd, Anna Ryan, Eleanor Flynn, Geoff McColl
Large-scale interview and simulation-based assessments such as objective structured clinical examinations (OSCEs) and multiple mini interviews (MMIs) are logistically complex to administer, generate large volumes of assessment data, and are strong candidates for the adoption of computer-based marking systems. Adoption of new technologies can be challenging, and technical failures, which are relatively commonplace, can delay and/or create resistance to ongoing implementation.This paper reports on the adoption process of an electronic marking system for OSCEs and MMIs following an unsuccessful initial trial...
August 17, 2017: Perspectives on Medical Education
https://www.readbyqxmd.com/read/28818518/seladelpar-mbx-8025-a-selective-ppar-%C3%AE-agonist-in-patients-with-primary-biliary-cholangitis-with-an-inadequate-response-to-ursodeoxycholic-acid-a-double-blind-randomised-placebo-controlled-phase-2-proof-of-concept-study
#4
David Jones, Pol F Boudes, Mark G Swain, Christopher L Bowlus, Michael R Galambos, Bruce R Bacon, Yvonne Doerffel, Norman Gitlin, Stuart C Gordon, Joseph A Odin, David Sheridan, Markus-Alexander Wörns, Virginia Clark, Linsey Corless, Heinz Hartmann, Mark E Jonas, Andreas E Kremer, George F Mells, Peter Buggisch, Bradley L Freilich, Cynthia Levy, John M Vierling, David E Bernstein, Marek Hartleb, Ewa Janczewska, Fedja Rochling, Hemant Shah, Mitchell L Shiffman, John H Smith, Yun-Jung Choi, Alexandra Steinberg, Monika Varga, Harinder Chera, Robert Martin, Charles A McWherter, Gideon M Hirschfield
BACKGROUND: Many patients with primary biliary cholangitis have an inadequate response to first-line therapy with ursodeoxycholic acid. Seladelpar is a potent, selective agonist for the peroxisome proliferator-activated receptor-delta (PPAR-δ), which is implicated in bile acid homoeostasis. This first-in-class study evaluated the anti-cholestatic effects and safety of seladelpar in patients with an inadequate response to ursodeoxycholic acid. METHODS: The study was a 12-week, double-blind, placebo-controlled, phase 2 trial of patients with alkaline phosphatase of at least 1·67 times the upper limit of normal (ULN) despite treatment with ursodeoxycholic acid...
August 14, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28818316/predicting-in-hospital-mortality-in-patients-with-acute-coronary-syndrome-in-china
#5
Yong Peng, Xin Du, Kris D Rogers, Yangfeng Wu, Runlin Gao, Anushka Patel
Currently available risk scores (RSs) were derived from populations with very few participants from China. We aimed to develop an RS based on data from patients with acute coronary syndrome in China and to compare its performance with the commonly promoted Global Registry of Acute Coronary Events (GRACE) RS. Clinical Pathways for Acute Coronary Syndromes-Phase 2 was a trial of a quality improvement intervention in China. Patients recruited from 75 hospitals from October 2007 to August 2010 were divided into training and validation sets based on immediate or delayed implementation...
July 19, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28816704/comparison-between-corticosteroid-and-lidocaine-injection-in-the-treatment-of-tennis-elbow-a-randomized-double-blinded-controlled-trial
#6
Lin-Fen Hsieh, Ying-Chen Kuo, Chia-Cheng Lee, Ya-Fang Liu, Yu-Chia Liu, Vincent Huang
OBJECTIVE: The aim of the study was to compare the effects of corticosteroid injection with lidocaine injection in treating tennis elbow. DESIGN: It is a prospective, double-blinded, randomized controlled trial. Patients with tennis elbow for more than 1 mo were recruited from a hospital-based rehabilitation outpatient clinic. A total of 70 patients were recruited, and 61 patients completed the study. Patients received an injection of either 10 mg (1 ml) of triamcinolone (corticosteroid group, n = 30) or 1 ml of 1% lidocaine (lidocaine group, n = 31)...
August 14, 2017: American Journal of Physical Medicine & Rehabilitation
https://www.readbyqxmd.com/read/28816293/-effects-of-bioactive-glass-on-reducing-the-hypersensitivity-after-full-crown-preparation
#7
H Li, Y H Liu, Z Q Luo
OBJECTIVE: To evaluate the efficacy of the 45S5 bioactive glass on the reduction of hypersensitivity of teeth prepared for full coverage crowns. METHODS: In the study, 31 prepared abutment teeth with vital pulp from 18 patients satisfied the inclusion criteria and exclusion criteria. The patients were informed consent and recruited into the study. This was a before and after self-control, single blind clinical trial. The severity of tooth hypersensitivity at baseline was evaluated, after application of the placebo, which was the powder of zinc oxide, and after application of the 45S5 bioactive glass on the same tooth...
August 18, 2017: Beijing da Xue Xue Bao. Yi Xue Ban, Journal of Peking University. Health Sciences
https://www.readbyqxmd.com/read/28816141/combined-radiation-therapy-and-immune-checkpoint-blockade-therapy-for-breast-cancer
#8
REVIEW
Zishuo I Hu, Alice Y Ho, Heather L McArthur
PURPOSE: Treatment with checkpoint inhibitors has shown durable responses in a number of solid tumors, including melanoma, lung, and renal cell carcinoma. However, most breast cancers are resistant to monotherapy with checkpoint inhibitors. Radiation therapy (RT) has been shown to have a number of immunostimulatory effects, including priming the immune system, recruiting immune cells to the tumor environment, and altering the immunosuppressive effects of the tumor microenvironment. RT therefore represents a promising adjuvant therapy to checkpoint blockade in breast cancer...
September 1, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28814837/simulating-clinical-trial-visits-yields-patient-insights-into-study-design-and-recruitment
#9
S Sam Lim, Alan J Kivitz, Doug McKinnell, M Edward Pierson, Faye S O'Brien
PURPOSE: We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention. PATIENTS AND METHODS: Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA...
2017: Patient Preference and Adherence
https://www.readbyqxmd.com/read/28814317/collaborative-care-for-panic-disorder-generalised-anxiety-disorder-and-social-phobia-in-general-practice-study-protocol-for-three-cluster-randomised-superiority-trials
#10
Nadja Kehler Curth, Ursula Ødum Brinck-Claussen, Annette Sofie Davidsen, Marianne Engelbrecht Lau, Merete Lundsteen, John Hagel Mikkelsen, Claudio Csillag, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov
BACKGROUND: People with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately...
August 16, 2017: Trials
https://www.readbyqxmd.com/read/28813696/effects-of-standardized-home-training-in-patients-with-cognitive-impairment-following-geriatric-rehabilitation-a-randomized-controlled-pilot-study
#11
Klaus Hauer, Phoebe Ullrich, Ilona Dutzi, Rainer Beurskens, Sylvia Kern, Jürgen Bauer, Michael Schwenk
BACKGROUND: Post-ward geriatric rehabilitation programs have hardly been developed and validated, which leaves a substantial gap in rehabilitative care in older adults and hinders full exploitation of maintained, but often unrecognized rehabilitation potentials. Geriatric rehabilitation patients with cognitive impairment represent a highly vulnerable population which is often affected by a lack of an ongoing support at the intersection between ward-based and post-ward rehabilitation. OBJECTIVE: To determine the effect of a standardized home-based training program in geriatric patients with cognitive impairment following ward-based rehabilitation...
August 17, 2017: Gerontology
https://www.readbyqxmd.com/read/28811716/development-and-validation-of-a-simple-and-multifaceted-instrument-gerd-test-for-the-clinical-evaluation-of-gastroesophageal-reflux-and-dyspeptic-symptoms
#12
Koji Nakada, Nobuyuki Matsuhashi, Katsuhiko Iwakiri, Atsushi Oshio, Takashi Joh, Kazuhide Higuchi, Ken Haruma
AIM: To evaluate the psychometric properties of a newly developed questionnaire, known as the gastroesophageal reflux and dyspepsia therapeutic efficacy and satisfaction test (GERD-TEST), in patients with GERD. METHODS: Japanese patients with predominant GERD symptoms recruited according to the Montreal definition were treated for 4 wk using a standard dose of proton pump inhibitor (PPI). The GERD-TEST and the Medical Outcome Study Short Form-8 Health Survey (SF-8) were administered at baseline and after 4 wk of treatment...
July 28, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28810853/acute-effects-of-reducing-sitting-time-in-adolescents-a-randomized-cross-over-study
#13
Anisse Penning, Anthony D Okely, Stewart G Trost, Jo Salmon, Dylan P Cliff, Marijka Batterham, Steven Howard, Anne-Maree Parrish
BACKGROUND: Levels of sitting among adolescents are high, especially during the school day. The acute cognitive and health consequences associated with prolonged sitting are poorly understood in adolescents. This randomized crossover design study examined the acute effects of a simulated school day with reduced sitting or usual sitting on adolescents' cognitive function and cardiometabolic biomarkers. METHODS: Eighteen healthy school aged adolescents were recruited from the community to the study (11 males; 7 females; mean age [SD] = 13...
August 15, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28809926/impact-of-fortified-versus-unfortified-lipid-based-supplements-on-morbidity-and-nutritional-status-a-randomised-double-blind-placebo-controlled-trial-in-ill-gambian-children
#14
Stefan A Unger, Saikou Drammeh, Jahid Hasan, Kabiru Ceesay, Edrisa Sinjanka, Sainey Beyai, Bakary Sonko, Bai Lamin Dondeh, Anthony J Fulford, Sophie E Moore, Andrew M Prentice
BACKGROUND: Multiple micronutrients (MMN) are commonly prescribed in pediatric primary healthcare in sub-Saharan Africa to improve nutritional status and appetite without evidence for their effectiveness or international clinical guidelines. Community-wide MMN supplementation has shown limited and heterogeneous impact on growth and morbidity. Short-term ready-to-use therapeutic foods in acutely sick children in a hospital setting also had limited efficacy regarding subsequent growth. The effectiveness of MMN in improving morbidity or growth in sick children presenting for primary care has not been assessed...
August 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28809383/increasing-symptoms-in-irritable-bowel-symptoms-with-ingestion-of-galacto-oligosaccharides-are-mitigated-by-%C3%AE-galactosidase-treatment
#15
C J Tuck, K M Taylor, P R Gibson, J S Barrett, J G Muir
OBJECTIVES: Galacto-oligosaccharides (GOS) are dietary FODMAPs (fermentable carbohydrates) associated with triggering gastrointestinal symptoms in patients with irritable bowel syndrome (IBS). This randomized, double-blind, placebo-controlled, cross-over trial aimed to assess whether oral α-galactosidase co-ingestion with foods high in GOS and low in other FODMAPs would reduce symptoms. METHODS: Patients meeting the Rome III criteria for IBS who were hydrogen-producers on breath testing were recruited...
August 15, 2017: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/28808192/classification-of-facial-wrinkles-among-chinese-women
#16
Jiechen Zhang, Wei Hou, Suying Feng, Xiangsheng Chen, Hongwei Wang
It is generally recognized that Caucasians and Asians have different skin aging features. The aim of this study was to develop a facial wrinkle grading scale for Chinese women. Standard photographs were taken of 242 Chinese women. Six sets of 0 to 9 wrinkle scales with reference photographs and descriptions were selected, including grading scales for resting and hyperkinetic crow's feet, frontalis lines, glabellar frown lines, and nasolabial folds. To identify the scale by objective quantitative measurement, skin surface measurements from the Visioscan(®) VC98 were used...
January 19, 2017: Journal of Biomedical Research
https://www.readbyqxmd.com/read/28807395/clinical-validation-of-pinopode-as-a-marker-of-endometrial-receptivity-a-randomized-controlled-trial
#17
Zhang Qiong, Hao Jie, Wang Yonggang, Xu Bin, Zhao Jing, Li Yanping
OBJECTIVE: To determine the clinical value of pinopodes in the human. DESIGN: Randomized controlled trial. SETTING: Academic fertility center. PATIENT(S): From December 2014 to December 2016, in a phase I trial, 363 patients were recruited in their first IVF cycles. In a phase II trial, 136 patients with at least two previous embryo implantation failures were recruited. INTERVENTION(S): In the phase I trial, in the midluteal phase, endometrial tissues were obtained for scanning electron microscopy, and their IVF treatment outcomes were followed up...
August 11, 2017: Fertility and Sterility
https://www.readbyqxmd.com/read/28806199/does-late-hip-dysplasia-occur-after-normal-ultrasound-screening-in-breech-babies
#18
Andrew R Morris, Joanna M C Thomas, Isabel C Reading, Nicholas M P Clarke
BACKGROUND: Recent literature has raised concern regarding the occurrence of late dysplasia after normal screening in breech babies. One paper states a late dysplasia incidence of 29%. This finding is in contrast with other published work, which suggests breech presentation is predictive of spontaneous stabilization of the unstable neonatal hip. We decided to identify the rate of late dysplasia after normal screening in our patient cohort and also to investigate the use of a prophylactic abduction diaper...
August 11, 2017: Journal of Pediatric Orthopedics
https://www.readbyqxmd.com/read/28806190/the-challenges-of-proprotein-convertase-subtilisin-kexin-9-inhibitors-for-lipid-guidelines-and-models-of-care
#19
Anthony S Wierzbicki
PURPOSE OF REVIEW: The article reviews the challenges facing cardiovascular disease (CVD) guidelines committees. RECENT FINDINGS: Clinical trials in high-risk populations have shown additional CVD event reduction with ezetimibe and proprotein convertase subtilisin-kexin-9 inhibitors. These trials recruit middle-aged secondary prevention populations, whereas increasingly the population at risk of CVD comprises the elderly in primary prevention. Some major guidelines have moved from a lipid-target to a risk-based approach...
August 12, 2017: Current Opinion in Lipidology
https://www.readbyqxmd.com/read/28804246/the-role-of-functional-social-and-mobility-dynamics-in-facilitating-older-african-americans-participation-in-clinical-research
#20
Eve T Shapiro, Jay T Schamel, Kimberly A Parker, Laura A Randall, Paula M Frew
PURPOSE: Older African Americans experience disproportionately higher incidence of morbidity and mortality related to chronic and infectious diseases, yet are significantly underrepresented in clinical research compared to other racial and ethnic groups. This study aimed to understand the extent to which social support, transportation access, and physical impediments function as barriers or facilitators to clinical trial recruitment of older African Americans. METHODS: Participants (N=221) were recruited from six African American churches in Atlanta and surveyed on various influences on clinical trial participation...
2017: Open Access Journal of Clinical Trials
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