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Clinical trial recruitment

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https://www.readbyqxmd.com/read/27923043/clonal-evolutionary-analysis-during-her2-blockade-in-her2-positive-inflammatory-breast-cancer-a-phase-ii-open-label-clinical-trial-of-afatinib-vinorelbine
#1
Gerald Goh, Ramona Schmid, Kelly Guiver, Wichit Arpornwirat, Imjai Chitapanarux, Vinod Ganju, Seock-Ah Im, Sung-Bae Kim, Arunee Dechaphunkul, Jedzada Maneechavakajorn, Neil Spector, Thomas Yau, Mehdi Afrit, Slim Ben Ahmed, Stephen R Johnston, Neil Gibson, Martina Uttenreuther-Fischer, Javier Herrero, Charles Swanton
BACKGROUND: Inflammatory breast cancer (IBC) is a rare, aggressive form of breast cancer associated with HER2 amplification, with high risk of metastasis and an estimated median survival of 2.9 y. We performed an open-label, single-arm phase II clinical trial (ClinicalTrials.gov NCT01325428) to investigate the efficacy and safety of afatinib, an irreversible ErbB family inhibitor, alone and in combination with vinorelbine in patients with HER2-positive IBC. This trial included prospectively planned exome analysis before and after afatinib monotherapy...
December 2016: PLoS Medicine
https://www.readbyqxmd.com/read/27922448/the-second-randomised-evaluation-of-the-effectiveness-cost-effectiveness-and-acceptability-of-computerised-therapy-reeact-2-trial-does-the-provision-of-telephone-support-enhance-the-effectiveness-of-computer-delivered-cognitive-behaviour-therapy-a-randomised
#2
Sally Brabyn, Ricardo Araya, Michael Barkham, Peter Bower, Cindy Cooper, Ana Duarte, David Kessler, Sarah Knowles, Karina Lovell, Elizabeth Littlewood, Richard Mattock, Stephen Palmer, Jodi Pervin, David Richards, Debbie Tallon, David White, Simon Walker, Gillian Worthy, Simon Gilbody
BACKGROUND: Computerised cognitive behaviour therapy (cCBT) is an efficient form of therapy potentially improving access to psychological care. Indirect evidence suggests that the uptake and effectiveness of cCBT can be increased if facilitated by telephone, but this is not routinely offered in the NHS. OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of telephone-facilitated free-to-use cCBT [e.g. MoodGYM (National Institute for Mental Health Research, Australian National University, Canberra, ACT, Australia)] with minimally supported cCBT...
November 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27922028/a-randomized-double-blind-placebo-controlled-trial-to-examine-the-effectiveness-of-lubiprostone-on-constipation-symptoms-and-colon-transit-time-in-diabetic-patients
#3
Jennifer Christie, Sagar Shroff, Nikrad Shahnavaz, Latoya A Carter, Melanie S Harrison, Karan A Dietz-Lindo, John Hanfelt, Shanthi Srinivasan
OBJECTIVES: Constipation is the most common GI symptom in patients with diabetes mellitus (DM). Importantly, patients with constipation have lower health-related quality of life than those without constipation. Effective therapies for constipation are limited and there is a paucity of data evaluating the treatment of constipation in diabetics. METHODS: Diabetic patients with chronic idiopathic constipation (CIC) as defined by Rome III criteria were recruited from outpatient clinics at a tertiary-care center and a Veterans Administration Hospital...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27921223/psychometric-properties-of-the-chinese-version-of-the-reproductive-concerns-after-cancer-scale-rcac-for-young-female-cancer-survivors
#4
Ting-Ting Qiao, Wei Zheng, Wei Xing, Li-Xia Zhang, Wei Zhang, Yan-Ping Shi, Xiao-Juan Chen
PURPOSE: This study aimed to translate, culturally adapt, and test the psychometric properties of the Reproductive Concerns After Cancer scale (RCAC) in young Chinese female cancer survivors. METHODS: The Chinese version of the RCAC was developed using the standard Functional Assessment of Chronic Illness Therapy (FACIT) translation methodology, and then 800 young Chinese female cancer survivors were recruited to complete the scale. The validation of the RCAC is as follows: (1) content validity was evaluated by a group of experts; (2) factor structure was assessed using confirmatory factor analysis and factorial invariance analysis; (3) convergent validity was determined by correlations with the Patient Health Questionnaire 9 (PHQ-9) and Functional Assessment of Cancer Therapy-General (FACT-G) scale; (4) internal consistency reliability was assessed using Cronbach's α coefficient; and (5) test-retest reliability was assessed using intra-class correlations...
December 5, 2016: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/27921093/evaluation-of-a-novel-semi-automated-ultrasound-system-for-the-detection-of-synovitis-a-prospective-study-involving-45-patients-with-rheumatoid-arthritis
#5
M Witt, J Frielinghausen, R Mueller, F Mueller, F Proft, H Schulze-Koops, M Grunke, D-A Clevert
Background: Arthrosonography has proven to be more sensitive and reliable for the detection of synovitis than clinical examination, but a comprehensive examination of small joints is time-consuming. The automated breast volume scanner (ABVS) has been developed to allow automatic and reproducible series of consecutive B-mode pictures of the female breast. Objectives: To analyze the comparability of ABVS and conventional manual ultrasonography (mUS) for the detection of synovitis in hands and feet of patients with rheumatoid arthritis (RA)...
November 2016: Ultrasound International Open
https://www.readbyqxmd.com/read/27920468/immune-checkpoint-therapy-for-pancreatic-cancer
#6
REVIEW
Henrik Johansson, Roland Andersson, Monika Bauden, Sarah Hammes, Stefan Holdenrieder, Daniel Ansari
Novel treatment modalities are necessary for pancreatic cancer. Immunotherapy with immune checkpoint inhibition has shown effect in other solid tumors, and could have a place in pancreatic cancer treatment. Most available clinical studies on immune checkpoint inhibitors for pancreatic cancer are not yet completed and are still recruiting patients. Among the completed trials, there have been findings of a preliminary nature such as delayed disease progression and enhanced overall survival after treatment with immune checkpoint inhibitors in mono- or combination therapy...
November 21, 2016: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/27920416/re-evaluating-the-inhibition-of-stress-erosions-revise-a-protocol-for-pilot-randomized-controlled-trial
#7
Waleed Alhazzani, Gordon Guyatt, John C Marshall, Richard Hall, John Muscedere, Francois Lauzier, Lehana Thabane, Mohammed Alshahrani, Shane W English, Yaseen M Arabi, Adam M Deane, Tim Karachi, Bram Rochwerg, Simon Finfer, Nick Daneman, Nicole Zytaruk, Diane Heel-Ansdell, Deborah Cook, On Behalf Of
INTRODUCTION: Clinicians routinely administer stress ulcer prophylaxis to mechanically ventilated patients in the intensive care unit (ICU), most commonly prescribing proton pump inhibitors (PPIs). However, the incidence of gastrointestinal (GI) bleeding from stress ulceration is low and recent observational studies suggest these agents may increase infections. Therefore, a large randomized clinical trial (RCT) is needed to inform modern practice. The aim of this multicenter pilot trial is to determine the feasibility of performing a large RCT to investigate the efficacy and safety of withholding intravenous pantoprazole...
November 2016: Annals of Saudi Medicine
https://www.readbyqxmd.com/read/27919864/taxonomy-for-the-rehabilitation-of-knee-conditions-trak-a-digital-intervention-to-support-the-self-care-components-of-anterior-cruciate-ligament-rehabilitation-protocol-of-a-feasibility-study
#8
Emma Dunphy, Fiona L Hamilton, Kate Button
BACKGROUND: Rupture of the anterior cruciate ligament (ACL) is common, especially in the active population. In defining the problem of ACL rehabilitation, this study draws from the knowledge that improved self-care, strength, and fitness are associated with better outcomes. Traditional rehabilitation involves regular physiotherapy, but it is not clear what the optimal way for delivering rehabilitation is, and it varies widely across the world. Evidence for treatments are discussed in the literature, however standard length of rehabilitation and frequency of appointments are unknown...
December 5, 2016: JMIR Research Protocols
https://www.readbyqxmd.com/read/27919393/business-analysis-for-a-sustainable-multi-stakeholder-ecosystem-for-leveraging-the-electronic-health-records-for-clinical-research-ehr4cr-platform-in-europe
#9
Danielle Dupont, Ariel Beresniak, Mats Sundgren, Andreas Schmidt, John Ainsworth, Pascal Coorevits, Dipak Kalra, Marc Dewispelaere, Georges De Moor
INTRODUCTION: The Electronic Health Records for Clinical Research (EHR4CR) technological platform has been developed to enable the trustworthy reuse of hospital electronic health records data for clinical research. The EHR4CR platform can enhance and speed up clinical research scenarios: protocol feasibility assessment, patient identification for recruitment in clinical trials, and clinical data exchange, including for reporting serious adverse events. Our objective was to seed a multi-stakeholder ecosystem to enable the scalable exploitation of the EHR4CR platform in Europe, and to assess its economic sustainability...
January 2017: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/27919251/a-randomised-controlled-trial-of-sensory-awareness-training-and-additional-motor-practice-for-learning-scalpel-skills-in-podiatry-students
#10
Ryan S Causby, Michelle N McDonnell, Lloyd Reed, Susan L Hillier
BACKGROUND: The process of using a scalpel, like all other motor activities, is dependent upon the successful integration of afferent (sensory), cognitive and efferent (motor) processes. During learning of these skills, even if motor practice is carefully monitored there is still an inherent risk involved. It is also possible that this strategy could reinforce high levels of anxiety experienced by the student and affect student self-efficacy, causing detrimental effects on motor learning...
December 5, 2016: BMC Medical Education
https://www.readbyqxmd.com/read/27919234/blended-cbt-versus-face-to-face-cbt-a-randomised-non-inferiority-trial
#11
Kim Mathiasen, Tonny E Andersen, Heleen Riper, Annet A M Kleiboer, Kirsten K Roessler
BACKGROUND: Internet based cognitive behavioural therapy (iCBT) has been demonstrated to be cost- and clinically effective. There is a need, however, for increased therapist contact for some patient groups. Combining iCBT with traditional face-to-face (ftf) consultations in a blended format (B-CBT) may produce a new treatment format with multiple benefits from both traditional CBT and iCBT such as individual adaptation, lower costs than traditional therapy, wide geographical and temporal availability, and possibly lower threshold to implementation...
December 5, 2016: BMC Psychiatry
https://www.readbyqxmd.com/read/27918976/randomized-controlled-trial-of-a-family-oriented-self-management-program-to-improve-self-efficacy-glycemic-control-and-quality-of-life-among-thai-individuals-with-type-2-diabetes
#12
Nutchanath Wichit, George Mnatzaganian, Mary Courtney, Paula Schulz, Maree Johnson
AIMS: We evaluated a theoretically-derived family-oriented intervention aimed to improve self-efficacy, self-management, glycemic control and quality of life in individuals living with Type 2 diabetes in Thailand. METHODS: In a single-blinded randomized controlled trial, 140 volunteer individuals with Type 2 diabetes, recruited from a diabetes clinic in rural Thailand, were randomly allocated to intervention and control arms. Those in the intervention arm received routine care plus a family-oriented program that included education classes, group discussions, a home visit, and a telephone follow-up while the control arm only received routine care...
November 19, 2016: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/27918931/effectiveness-of-an-educational-intervention-the-encourage-autonomous-self-enrichment-program-in-patients-with-chronic-kidney-disease-a-randomized-controlled-trial
#13
Hiroko Joboshi, Michiyo Oka
BACKGROUND: Self-management is an important step toward preventing and impeding the progression of chronic kidney disease. However, patients with chronic kidney disease may have few or no subjective symptoms and therefore might consider self-management to be unnecessary. Effective support and encouragement of self-management in patients with chronic kidney disease is therefore required. OBJECTIVES: This study tested the effectiveness of the Encourage Autonomous Self-Enrichment patient education program, which supports patient autonomy and intrinsic motivations with the aim of improving self-efficacy and sustaining self-management, on perceived self-efficacy, self-management behaviors, and physiological endpoints (blood pressure and renal function parameters) in patients with chronic kidney disease...
November 22, 2016: International Journal of Nursing Studies
https://www.readbyqxmd.com/read/27918382/conventional-versus-prolonged-infusion-of-meropenem-in-neonates-with-gram-negative-late-onset-sepsis-a-randomized-controlled-trial
#14
Abd Elazeez Shabaan, Islam Nour, Heba Elsayed Eldegla, Nehad Nasef, Basma Shouman, Hesham Abdel-Hady
BACKGROUND: Gram-negative bacteria are associated with significant morbidity and mortality in preterm and term newborns. Meropenem has widespread efficacy and often allows for monotherapy in this group. Prolonged infusion instead of infusion over 30 minutes has been suggested to result in higher microbiologic efficacy. OBJECTIVE: To compare the clinical and microbiologic efficacy and safety of prolonged infusions versus conventional dosing of meropenem in neonates with Gram negative late onset sepsis (GN-LOS)...
November 30, 2016: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/27918189/mentalization-based-therapy-for-parents-in-entrenched-conflict-a-random-allocation-feasibility-study
#15
Leezah Hertzmann, Mary Target, David Hewison, Polly Casey, Pasco Fearon, Dana Lassri
To explore the effectiveness of a mentalization-based therapeutic intervention specifically developed for parents in entrenched conflict over their children. To the best of our knowledge, this is the first randomized controlled intervention study in the United Kingdom to work with both parents postseparation, and the first to focus on mentalization in this situation. Using a mixed-methods study design, 30 parents were randomly allocated to either mentalization-based therapy for parental conflict-Parenting Together, or the Parents' Group, a psycho-educational intervention for separated parents based on elements of the Separated Parents Information Program-part of the U...
December 2016: Psychotherapy
https://www.readbyqxmd.com/read/27917150/nurse-led-intervention-to-improve-knowledge-of-medications-in-survivors-of-stroke-or-transient-ischemic-attack-a-cluster-randomized-controlled-trial
#16
Muideen T Olaiya, Dominique A Cadilhac, Joosup Kim, David Ung, Mark R Nelson, Velandai K Srikanth, Christopher F Bladin, Richard P Gerraty, Sharyn M Fitzgerald, Thanh G Phan, Judith Frayne, Amanda G Thrift
INTRODUCTION: Limited evidence exists on effective interventions to improve knowledge of preventive medications in patients with chronic diseases, such as stroke. We investigated the effectiveness of a nurse-led intervention, where a component was to improve knowledge of prevention medications, in patients with stroke or transient ischemic attack (TIA). METHODS: Prospective sub-study of the Shared Team Approach between Nurses and Doctors for Improved Risk Factor Management, a randomized controlled trial of risk factor management...
2016: Frontiers in Neurology
https://www.readbyqxmd.com/read/27916514/dipeptidyl-peptidase-4-inhibitors-and-protection-against-stroke-a-systematic-review-and-meta-analysis
#17
REVIEW
F Barkas, M Elisaf, V Tsimihodimos, H Milionis
BACKGROUND: Type 2 diabetes mellitus (T2DM) is associated with an increased risk of stroke and an unfavourable outcome following stroke. Apart from pioglitazone, glucose-lowering modalities have not been shown to protect against stroke. Nevertheless, there is evidence from experimental studies of potential neuroprotective effects with dipeptidyl peptidase (DPP)-4 inhibitors, especially if treatment starts before stroke. OBJECTIVE: To perform a meta-analysis of available evidence regarding the risk of stroke in individuals taking DPP-4 inhibitors...
December 1, 2016: Diabetes & Metabolism
https://www.readbyqxmd.com/read/27916234/phantom-motor-execution-facilitated-by-machine-learning-and-augmented-reality-as-treatment-for-phantom-limb-pain-a-single-group-clinical-trial-in-patients-with-chronic-intractable-phantom-limb-pain
#18
Max Ortiz-Catalan, Rannveig A Guðmundsdóttir, Morten B Kristoffersen, Alejandra Zepeda-Echavarria, Kerstin Caine-Winterberger, Katarzyna Kulbacka-Ortiz, Cathrine Widehammar, Karin Eriksson, Anita Stockselius, Christina Ragnö, Zdenka Pihlar, Helena Burger, Liselotte Hermansson
BACKGROUND: Phantom limb pain is a debilitating condition for which no effective treatment has been found. We hypothesised that re-engagement of central and peripheral circuitry involved in motor execution could reduce phantom limb pain via competitive plasticity and reversal of cortical reorganisation. METHODS: Patients with upper limb amputation and known chronic intractable phantom limb pain were recruited at three clinics in Sweden and one in Slovenia. Patients received 12 sessions of phantom motor execution using machine learning, augmented and virtual reality, and serious gaming...
December 1, 2016: Lancet
https://www.readbyqxmd.com/read/27914656/chronic-oral-study-of-myosin-activation-to-increase-contractility-in-heart-failure-cosmic-hf-a-phase-2-pharmacokinetic-randomised-placebo-controlled-trial
#19
John R Teerlink, G Michael Felker, John J V McMurray, Scott D Solomon, Kirkwood F Adams, John G F Cleland, Justin A Ezekowitz, Assen Goudev, Peter Macdonald, Marco Metra, Veselin Mitrovic, Piotr Ponikowski, Pranas Serpytis, Jindrich Spinar, János Tomcsányi, Hans J Vandekerckhove, Adriaan A Voors, Maria Laura Monsalvo, James Johnston, Fady I Malik, Narimon Honarpour
BACKGROUND: Impaired contractility is a feature of heart failure with reduced ejection fraction. We assessed the pharmacokinetics and effects on cardiac function and structure of the cardiac myosin activator, omecamtiv mecarbil. METHODS: In this randomised, double-blind study, done at 87 sites in 13 countries, we recruited patients with stable, symptomatic chronic heart failure and left ventricular ejection fraction 40% or lower. Patients were randomly assigned equally, via an interactive web response system, to receive 25 mg oral omecamtiv mecarbil twice daily (fixed-dose group), 25 mg twice daily titrated to 50 mg twice daily guided by pharmacokinetics (pharmacokinetic-titration group), or placebo for 20 weeks...
November 30, 2016: Lancet
https://www.readbyqxmd.com/read/27914133/lobeglitazone-a-novel-thiazolidinedione-improves-non-alcoholic-fatty-liver-disease-in-type-2-diabetes-its-efficacy-and-predictive-factors-related-to-responsiveness
#20
Yong Ho Lee, Jae Hyeon Kim, So Ra Kim, Heung Yong Jin, Eun Jung Rhee, Young Min Cho, Byung Wan Lee
Despite the rapidly increasing prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes (T2D), few treatment modalities are currently available. We investigated the hepatic effects of the novel thiazolidinedione (TZDs), lobeglitazone (Duvie) in T2D patients with NAFLD. We recruited drug-naïve or metformin-treated T2D patients with NAFLD to conduct a multicenter, prospective, open-label, exploratory clinical trial. Transient liver elastography (Fibroscan®; Echosens, Paris, France) with controlled attenuation parameter (CAP) was used to non-invasively quantify hepatic fat contents...
January 2017: Journal of Korean Medical Science
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