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Impactful clinical trials

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https://www.readbyqxmd.com/read/28549597/prolactin-receptor-targeting-in-breast-and-prostate-cancers-new-insights-into-an-old-challenge
#1
REVIEW
Vincent Goffin
In the era of precision medicine, the identification of new targets is a constant challenge to improve cancer therapy. Preclinical investigations, epidemiological studies and analyses of tissue specimens from patients strongly support the contribution of prolactin receptor (PRLR) signaling to breast and prostate tumorigenesis and cancer progression. Although a clear causative link with mutations of the genes encoding prolactin or its receptor is lacking, increased PRLR signaling in these cancers can be assessed by the overexpression of cognate proteins and is often confirmed by over-activation of downstream signaling effectors...
May 23, 2017: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28549592/economic-outcomes-of-pharmacist-physician-medication-therapy-management-for-polypharmacy-elderly-a-prospective-randomized-controlled-trial
#2
Hsiang-Wen Lin, Chih-Hsueh Lin, Chin-Kai Chang, Che-Yi Chou, I-Wen Yu, Cheng-Chieh Lin, Tsai-Chung Li, Chia-Ing Li, Yow-Wen Hsieh
BACKGROUND/PURPOSE: With an increasing geriatric population, the need for effective management of chronic conditions and medication use in the elderly is growing. Medication use in the elderly presents significant challenges due to changes in pharmacodynamic and pharmacokinetic profiles. We aimed to examine the impact of a collaborative physician-pharmacist medication therapy management (MTM) program for polypharmacy elderly patients. METHODS: Elderly patients with multiple chronic conditions on polypharmacy were enrolled in this prospective, randomized, and controlled study over 16 months of implementation...
May 23, 2017: Journal of the Formosan Medical Association, Taiwan Yi Zhi
https://www.readbyqxmd.com/read/28549309/switching-between-intravenous-and-subcutaneous-trastuzumab-safety-results-from-the-prefher-trial
#3
Joseph Gligorov, Giuseppe Curigliano, Volkmar Müller, Ann Knoop, Valerie Jenkins, Sunil Verma, Stuart Osborne, Sabine Lauer, Zuzana Machackova, Lesley Fallowfield, Xavier Pivot
AIM: To assess the safety and tolerability of switching between subcutaneous (SC) and intravenous (IV) trastuzumab in the PrefHer study (NCT01401166). PATIENTS AND METHODS: Patients with HER2-positive early breast cancer completed (neo)adjuvant chemotherapy and were randomised to receive four cycles of SC trastuzumab, via single-use injection device (SID; Cohort 1) or hand-held syringe (Cohort 2), followed by four cycles of IV, or vice versa (the crossover period presented here) as part of their 18 standard cycles of adjuvant trastuzumab treatment...
May 23, 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28547592/impact-of-interim-progression-during-the-surgery-to-radiotherapy-interval-and-its-predictors-in-glioblastoma-treated-with-temozolomide-based-radiochemotherapy
#4
Chan Woo Wee, Eunji Kim, Tae Min Kim, Chul-Kee Park, Jin Wook Kim, Seung Hong Choi, Roh-Eul Yoo, Soon-Tae Lee, Il Han Kim
This study was designed to investigate the impact of interim progression of disease (PD) during the surgery-to-radiotherapy interval (SRI) and its predictors in glioblastoma based on MRIs. A total of 222 patients were planned for radiotherapy (RT) and 166 of them were evaluable for the presence of interim PD by 2 separate MRIs. The size criteria from the updated Response Assessment in Neuro-Oncology criteria was adopted to determine interim PD. 32 (19.3%) patients experienced interim PD, and their median survival (MS) was shorter than patients without PD in univariate (11...
May 25, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28546815/role-of-statin-drugs-for-polycystic-ovary-syndrome
#5
REVIEW
Lisa Cassidy-Vu, Edwina Joe, Julienne K Kirk
Objective: To review the potential role and specific impact of statin drugs in women with PCOS. The evidence for this use of statins in PCOS is limited and still under further investigation. Materials and methods: A search was conducted using PubMed, DynaMed and PubMedHealth databases through October 16, 2016 using the terms polycystic ovary syndrome, PCOS, hydroxymethylglutaryl-CoA reductase inhibitors, hydroxymethylglutaryl-CoA, statin, atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin...
December 2016: Journal of Family & Reproductive Health
https://www.readbyqxmd.com/read/28546791/fecal-microbiota-transplantation-from-clostridium-difficile-to-inflammatory-bowel-disease
#6
Robert J Gianotti, Alan C Moss
Fecal microbiota transplantation (FMT) has evolved from a case report in the medical literature to the basis of major innovations in the treatment of Clostridium difficile infection (CDI) and, potentially, inflammatory bowel disease (IBD). In the clinical setting, FMT was noted to significantly lower the risk of recurrent CDI, likely by increasing microbial diversity and altering the metabolic environment in the intestinal tract of recipients. In parallel, advances in the ability to quantify and characterize microbial communities in fecal samples led to the association of IBD with a state of intestinal dysbiosis...
April 2017: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28546754/patient-perceived-health-related-quality-of-life-before-and-after-laparoscopic-aortobifemoral-bypass
#7
Syed Sh Kazmi, Anne H Krog, Simen T Berge, Jon O Sundhagen, Mehdi Sahba, Ragnhild S Falk
BACKGROUND: In patients operated with laparoscopic aortobifemoral bypass (LABFB) for atherosclerotic obstruction in aortoiliac segment, the main focus of the reports published during the last two decades has been morbidity and mortality. The primary objective of this study was to examine the health-related quality of life (HRQL) in these patients before and after LABFB. PATIENTS AND METHODS: Fifty consecutive patients (27 females) with Trans-Atlantic Inter-Society Consensus II, type D lesions were prospectively included...
2017: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/28546748/bronchiectasis-in-copd-patients-more-than-a-comorbidity
#8
Miguel Angel Martinez-Garcia, Marc Miravitlles
Computed tomography scan images have been used to identify different radiological COPD phenotypes based on the presence and severity of emphysema, bronchial wall thickening, and bronchiectasis. Bronchiectasis is defined as an abnormal dilation of the bronchi, usually as a result of chronic airway inflammation and/or infection. The prevalence of bronchiectasis in patients with COPD is high, especially in advanced stages. The identification of bronchiectasis in COPD has been defined as a different clinical COPD phenotype with greater symptomatic severity, more frequent chronic bronchial infection and exacerbations, and poor prognosis...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28546375/extracorporeal-membrane-oxygenation-for-severe-pediatric-respiratory-failure
#9
John C Lin
Extracorporeal membrane oxygenation (ECMO) was developed initially in the 1960s to support refractory respiratory failure in addition to the cardiac support inherent in a venoarterial bypass circuit. Early successes occurred predominantly in the neonatal population with subsequent randomized controlled trials and comprehensive reviews concluding therapeutic efficacy for ECMO in neonatal respiratory failure. In contrast, the evidence supporting ECMO for respiratory failure in children is less definitive. However, although pediatric randomized controlled trials have not been completed, sufficient evidence in support of ECMO as a beneficial therapy for pediatric respiratory failure exists...
June 2017: Respiratory Care
https://www.readbyqxmd.com/read/28545542/recognition-and-treatment-of-sleep-disordered-breathing-an-important-component-of-chronic-disease-management
#10
REVIEW
Peter C Farrell, Glenn Richards
Sleep-disordered breathing (SDB) is a highly prevalent condition, and is associated with many debilitating chronic diseases. The role of untreated obstructive sleep apnea (OSA) in arterial hypertension has been recognized in international guidelines. Treatment with continuous positive airway pressure (CPAP) is associated with clinically-relevant reductions in blood pressure. In heart failure (HF), SDB is associated with worse prognosis and increased mortality. Major HF guidelines recommend that patients should be treated for sleep apnea to improve their HF status...
May 25, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/28545535/electronic-audit-and-feedback-intervention-with-action-implementation-toolbox-to-improve-pain-management-in-intensive-care-protocol-for-a-laboratory-experiment-and-cluster-randomised-trial
#11
Wouter T Gude, Marie-José Roos-Blom, Sabine N van der Veer, Evert de Jonge, Niels Peek, Dave A Dongelmans, Nicolette F de Keizer
BACKGROUND: Audit and feedback is often used as a strategy to improve quality of care, however, its effects are variable and often marginal. In order to learn how to design and deliver effective feedback, we need to understand their mechanisms of action. This theory-informed study will investigate how electronic audit and feedback affects improvement intentions (i.e. information-intention gap), and whether an action implementation toolbox with suggested actions and materials helps translating those intentions into action (i...
May 25, 2017: Implementation Science: IS
https://www.readbyqxmd.com/read/28545508/open-label-versus-double-blind-placebo-treatment-in-irritable-bowel-syndrome-study-protocol-for-a-randomized-controlled-trial
#12
Sarah Ballou, Ted J Kaptchuk, William Hirsch, Judy Nee, Johanna Iturrino, Kathryn T Hall, John M Kelley, Vivian Cheng, Irving Kirsch, Eric Jacobson, Lisa Conboy, Anthony Lembo, Roger B Davis
BACKGROUND: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo...
May 25, 2017: Trials
https://www.readbyqxmd.com/read/28545493/three-approaches-to-glucose-monitoring-in-non-insulin-treated-diabetes-a-pragmatic-randomized-clinical-trial-protocol
#13
Laura A Young, John B Buse, Mark A Weaver, Maihan B Vu, April Reese, C Madeline Mitchell, Tamara Blakeney, Kimberlea Grimm, Jennifer Rees, Katrina E Donahue
BACKGROUND: For the nearly 75% of patients living with type 2 diabetes (T2DM) that do not use insulin, decisions regarding self-monitoring of blood glucose (SMBG) can be especially problematic. While in theory SMBG holds great promise for sparking favorable behavior change, it is a resource intensive activity without firmly established patient benefits. This study describes our study protocol to assess the impact of three different SMBG testing approaches on patient-centered outcomes in patients with non-insulin treated T2DM within a community-based, clinic setting...
May 25, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28545353/effect-of-magnesium-supplementation-on-plasma-c-reactive-protein-concentrations-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#14
Luis E Simental-Mendía, Amirhossein Sahebkar, Martha Rodríguez-Morán, Graciela Zambrano-Galván, Fernando Guerrero-Romero
BACKGROUND: Results of previous clinical trials evaluating the effect of magnesium supplementation on inflammatory markers are controversial. OBJECTIVE: A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to evaluating the effect of oral magnesium supplementation on plasma C-reactive protein (CRP) concentrations. METHOD: PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases were searched (from inception to August 09, 2016) to identify RCTs, evaluating the effect of magnesium on CRP levels...
May 25, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/28545312/strategies-to-improve-fertilisation-rates-with-assisted-conception-a-systematic-review
#15
Yadava Bapurao Jeve, Neelam Potdar, Jane A Blower, Tarek Gelbaya
Successful fertilisation is one of the key steps determining success of assisted conception. Various factors including sperm or oocyte pathology and environmental factors have a significant impact on fertilisation rates. This systematic review is aimed to evaluate the existing evidence about factors affecting fertilisation and strategies to improve fertilisation rates. A literature search was performed using Ovid MEDLINE ® (Jan 1950-April 2016), EMBASE (Jan 1950-April 2016), Ovid OLDMEDLINE ®, Pre-MEDLINE (Jan 1950-April 2016) and the Cochrane Library...
May 26, 2017: Human Fertility: Journal of the British Fertility Society
https://www.readbyqxmd.com/read/28544443/development-of-a-clinical-trials-version-of-the-impact-of-weight-on-quality-of-life-lite-questionnaire-iwqol-lite-clinical-trials-version-results-from-two-qualitative-studies
#16
R L Kolotkin, C M Ervin, H H Meincke, L Højbjerre, S E Fehnel
Existing measures of health-related quality of life and patient functioning in obesity, such as the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, lack the developmental rigour required by the Food and Drug Administration (FDA) to support product labelling. Two iterative qualitative studies informed development of a version of the IWQOL-Lite questionnaire optimized for use in obesity clinical trials: the IWQOL-Lite Clinical Trials Version. Study 1 included 42 patients with body mass index (BMI) ≥ 30 kg m(-2) (obesity); and Study 2 included 29 patients with type 2 diabetes and BMI ≥ 27 kg m(-2) (overweight)...
May 22, 2017: Clinical Obesity
https://www.readbyqxmd.com/read/28544391/the-experience-sampling-method-as-an-mhealth-tool-to-support-self-monitoring-self-insight-and-personalized-health-care-in-clinical-practice
#17
Jim van Os, Simone Verhagen, Anne Marsman, Frenk Peeters, Maarten Bak, Machteld Marcelis, Marjan Drukker, Ulrich Reininghaus, Nele Jacobs, Tineke Lataster, Claudia Simons, Richel Lousberg, Sinan Gülöksüz, Carsten Leue, Peter C Groot, Wolfgang Viechtbauer, Philippe Delespaul
BACKGROUND: The experience sampling method (ESM) builds an intensive time series of experiences and contexts in the flow of daily life, typically consisting of around 70 reports, collected at 8-10 random time points per day over a period of up to 10 days. METHODS: With the advent of widespread smartphone use, ESM can be used in routine clinical practice. Multiple examples of ESM data collections across different patient groups and settings are shown and discussed, varying from an ESM evaluation of a 6-week randomized trial of mindfulness, to a twin study on emotion dynamics in daily life...
May 23, 2017: Depression and Anxiety
https://www.readbyqxmd.com/read/28544279/controlled-clinical-trial-exploring-the-impact-of-a-brief-intervention-for-prevention-of-falls-in-an-emergency-department
#18
Kristie J Harper, Annette D Barton, Glenn Arendts, Deborah G Edwards, Antonio C Petta, Antonio Celenza
OBJECTIVE: To establish the effectiveness of a brief intervention to prevent falls in older patients presenting to the ED post-discharge. METHODS: The present study is a prospective single-centre, quasi-randomised controlled clinical trial of a brief targeted educational intervention to prevent falls. The intervention group received brief scripted education and were advised of their percentage probability of falling in the next 6 months. The key message was to reinforce the importance of falls prevention strategies and the seriousness of falls...
May 23, 2017: Emergency Medicine Australasia: EMA
https://www.readbyqxmd.com/read/28544202/breaking-up-sedentary-time-with-seated-upper-body-activity-can-regulate-metabolic-health-in-obese-high-risk-adults-a-randomised-crossover-trial
#19
Matthew McCarthy, Charlotte L Edwardson, Melanie J Davies, Joseph Henson, Alex Rowlands, James King, Danielle H Bodicoat, Kamlesh Khunti, Thomas Yates
AIMS: To investigate the impact of performing short bouts of seated upper body activity on postprandial blood glucose and insulin levels during prolonged sitting. MATERIALS AND METHODS: Participants undertook two 7 · 5 hour experimental conditions in a randomised order: 1) prolonged sitting only 2) sitting interspersed with 5 minutes of seated arm ergometry every 30 minutes. Blood samples were obtained while fasting and throughout the postprandial period following ingestion of two standardised meals...
May 23, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28543772/parp-inhibitor-rucaparib-induces-changes-in-nad-levels-in-cells-and-liver-tissues-as-assessed-by-mrs
#20
Gilberto S Almeida, Carlo M Bawn, Martin Galler, Ian Wilson, Huw D Thomas, Suzanne Kyle, Nicola J Curtin, David R Newell, Ross J Maxwell
Poly(adenosine diphosphate ribose) polymerases (PARPs) are multifunctional proteins which play a role in many cellular processes. Namely, PARP1 and PARP2 have been shown to be involved in DNA repair, and therefore are valid targets in cancer treatment with PARP inhibitors, such as rucaparib, currently in clinical trials. Proton magnetic resonance spectroscopy ((1) H-MRS) was used to study the impact of rucaparib in vitro and ex vivo in liver tissue from mice, via quantitative analysis of nicotinamide adenosine diphosphate (NAD(+) ) spectra, to assess the potential of MRS as a biomarker of the PARP inhibitor response...
May 22, 2017: NMR in Biomedicine
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