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Impactful clinical trials

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https://www.readbyqxmd.com/read/28646344/does-biomarker-information-impact-breast-cancer-patients-preferences-and-physician-recommendation-for-adjuvant-chemotherapy
#1
Ann H Partridge, Karen Sepucha, Anne O'Neill, Kathy D Miller, Emily Baker, Chau T Dang, Donald W Northfelt, George W Sledge, Bryan P Schneider
PURPOSE: This study aimed to examine how biomarker information would impact patients' preferences and physicians' recommendations for adjuvant breast cancer therapy. METHODS: At the 18-month follow-up, participants in a large, double-blind randomized controlled trial of adjuvant chemotherapy with bevacizumab or placebo (E5103) were surveyed about their preferred treatment (either chemotherapy A alone or chemotherapy A+B) in two hypothetical scenarios: (1) without biomarker information; and (2) after learning that they tested positive for a "B-receptor" which modestly increased both the benefit and toxicity expected with chemotherapy A+B...
June 23, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28646022/nf1-hematopoietic-cells-accelerate-malignant-peripheral-nerve-sheath-tumor-development-without-altering-chemotherapy-response
#2
Rebecca D Dodd, Chang-Lung Lee, Tess Overton, Wesley Huang, William C Eward, Lixia Luo, Yan Ma, Davis R Ingram, Keila E Torres, Diana M Cardona, Alexander Lazar, David G Kirsch
Haploinsufficiency in the tumor suppressor NF1 contributes to the pathobiology of type 1 neurofibromatosis, but a related role has not been established in malignant peripheral nerve sheath tumors (MPNST) where NF1 mutations also occur. Patients with NF1-associated MPNST appear to have worse outcomes than patients with sporadic MPNST, but the mechanism underlying this correlation is not understood. To define the impact of stromal genetics on the biology of this malignancy, we developed unique mouse models that reflect the genetics of patient-associated MPNST...
June 23, 2017: Cancer Research
https://www.readbyqxmd.com/read/28645473/efficacy-and-safety-of-rivaroxaban-versus-warfarin-in-patients-taking-nondihydropyridine-calcium-channel-blockers-for-atrial-fibrillation-from-the-rocket-af-trial
#3
Jeffrey B Washam, Anne S Hellkamp, Yuliya Lokhnygina, Jonathan P Piccini, Scott D Berkowitz, Christopher C Nessel, Richard C Becker, Günter Breithardt, Keith A A Fox, Jonathan L Halperin, Graeme J Hankey, Kenneth W Mahaffey, Daniel E Singer, Manesh R Patel
Non-dihydropyridine calcium channel blockers (non-DHP CCBs) possess combined P-glycoprotein and moderate CYP3A4 inhibition, which may lead to increased exposure of medications that are substrates for these metabolic pathways, such as rivaroxaban. We evaluated the use and outcomes of non-DHP CCBs in patients with atrial fibrillation (AF) in Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF)...
May 29, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28645365/complexity-of-immune-responses-to-aav-transgene-products-example-of-factor-ix
#4
REVIEW
Roland W Herzog
After two decades of research, in vivo gene transfer with adeno-associated viral (AAV) vectors has now resulted in successful treatments and even cures for several human diseases. However, the potential for immune responses against the therapeutic gene products remains one of the concerns as this approach is broadened to more patients, diverse diseases, and target organs. Immune responses following gene transfer of coagulation factor IX (FIX) for the treatment of the bleeding disorder hemophilia B has been extensively investigated in multiple animal models...
May 29, 2017: Cellular Immunology
https://www.readbyqxmd.com/read/28645301/the-sternal-management-accelerated-recovery-trial-s-m-a-r-t-standard-restrictive-versus-an-intervention-of-modified-sternal-precautions-following-cardiac-surgery-via-median-sternotomy-study-protocol-for-a-randomised-controlled-trial
#5
Md Ali Katijjahbe, Linda Denehy, Catherine L Granger, Alistair Royse, Colin Royse, Rebecca Bates, Sarah Logie, Sandy Clarke, Doa El-Ansary
BACKGROUND: The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound...
June 23, 2017: Trials
https://www.readbyqxmd.com/read/28644979/intraoperative-fast-ripples-independently-predict-postsurgical-epilepsy-outcome-comparison-with-other-electrocorticographic-phenomena
#6
Shaun A Hussain, Gary W Mathern, Phoebe Hung, Julius Weng, Raman Sankar, Joyce Y Wu
In the surgical management of epilepsy, the resection of cortex exhibiting interictal fast ripples (250-500Hz) on electrocorticography has been linked to postoperative seizure-freedom. Although fast ripples appear to accurately identify the epileptogenic zone-the minimum tissue that must be removed at surgery to achieve seizure-freedom-it has not been established that fast ripples are a superior biomarker in comparison with multimodal presurgical neuroimaging and other electrocorticography abnormalities. Hence, in the prediction of postoperative seizure-freedom, we compared the value of fast ripples with other intraoperative electocorticography abnormalities including focal slowing, paroxysmal fast activity, intermittent spike discharges, continuous epileptiform discharges, focal attenuation, and intraoperative seizures, as well as complete resection of the lesion defined by MRI and other neuroimaging...
June 16, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28644958/translating-cancer-epigenomics-into-the-clinic-focus-on-lung-cancer
#7
REVIEW
Josep Mari-Alexandre, Angel Diaz-Lagares, Maria Villalba, Oscar Juan, Ana B Crujeiras, Alfonso Calvo, Juan Sandoval
Epigenetic deregulation is increasingly being recognized as a hallmark of cancer. Recent studies have identified many new epigenetic biomarkers, some of which are being introduced into clinical practice for diagnosis, molecular classification, prognosis or prediction of response to therapies. O-6-methylguanine-DNA methyltransferase gene is the most clinically advanced epigenetic biomarker as it predicts the response to temozolomide and carmustine in gliomas. Therefore, epigenomics may represent a novel and promising tool for precision medicine, and in particular, the detection of epigenomic biomarkers in liquid biopsies will be of great interest for monitoring diseases in patients...
June 2, 2017: Translational Research: the Journal of Laboratory and Clinical Medicine
https://www.readbyqxmd.com/read/28644303/prostate-cancer-immunotherapy-the-path-forward
#8
Ravi A Madan, James L Gulley
PURPOSE OF REVIEW: To provide an overview of current strategies being investigated in the development of immunotherapy in prostate cancer. RECENT FINDINGS: Development of immunotherapy in prostate cancer actually began in 2010 with FDA approval of sipuleucel-T. Given that immune checkpoint inhibitor trials have either been negative at the phase III level or underwhelming in smaller studies, it is likely that combination strategies will be required to further maximize the impact immune-based therapies on the clinical course of the disease...
July 20, 2017: Current Opinion in Supportive and Palliative Care
https://www.readbyqxmd.com/read/28644261/is-intravenous-thrombolysis-safe-and-effective-in-central-retinal-artery-occlusion-a-critically-appraised-topic
#9
Oana M Dumitrascu, Joanne F Shen, Madhavi Kurli, Maria I Aguilar, Lisa A Marks, Bart M Demaerschalk, Dean M Wingerchuk, Cumara B O'Carroll
BACKGROUND: Central retinal artery occlusion (CRAO) is a neurological and ophthalmologic emergency associated with poor visual recovery. There is a dilemma regarding the appropriate treatment, as formal guidelines are lacking. Despite being considered an ocular equivalent of cerebral infarction, the time window of intravenous (IV) thrombolysis administration for maximum efficacy and safety in CRAO remains uncertain. OBJECTIVE: To critically assess the current evidence regarding the safety and effectiveness of IV thrombolysis in the treatment of patients with CRAO...
July 2017: Neurologist
https://www.readbyqxmd.com/read/28644196/cebranopadol-a-novel-first-in-class-analgesic-drug-candidate-first-experience-in-patients-with-chronic-low-back-pain-in-a-randomized-clinical-trial
#10
Annette Christoph, Marie-Henriette Eerdekens, Maurits Kok, Gisela Volkers, Rainer Freynhagen
Chronic low back pain (LBP) is a common condition, usually with involvement of nociceptive and neuropathic pain components, high economic burden and impact on quality of life. Cebranopadol is a potent, first-in-class drug candidate with a novel mechanistic approach, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. We conducted the first Phase II, randomized, doubleblind, placebo- and active-controlled trial, evaluating the analgesic efficacy, safety, and tolerability of cebranopadol in patients with moderate to severe chronic LBP with and without neuropathic pain component...
June 21, 2017: Pain
https://www.readbyqxmd.com/read/28644144/meta-analysis-of-the-clinical-characteristics-and-prognostic-relevance-of-notch1-and-fbxw7-mutation-in-t-cell-acute-lymphoblastic-leukemia
#11
Rong-Bin Liu, Jian-Gui Guo, Tian-Ze Liu, Cheng-Cheng Guo, Xin-Xiang Fan, Xiao Zhang, Xiu-Yu Cai, Wei-Han Hu
The NOTCH1 signaling pathway is crucial for T-cell development, and NOTCH1 and/or FBXW7 mutations are frequently detected in T-cell acute lymphoblastic leukemia (T-ALL). We performed a systematic review and meta-analysis of 18 randomized controlled trials (RCTs) to assess the prognostic impact of mutations in the NOTCH1 pathway. After retrieving relevant articles from PubMed, EMBASE, and the Cochrane Library, we investigated overall survival (OS) and event-free survival (EFS) with hazard ratios (HRs) using fixed-effects or random-effects models and conducted subgroup analyses based on population and mutation status...
June 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/28644115/evaluation-of-the-effectiveness-and-cost-effectiveness-of-lightweight-fibreglass-heel-casts-in-the-management-of-ulcers-of-the-heel-in-diabetes-a-randomised-controlled-trial
#12
William Jeffcoate, Frances Game, Vivienne Turtle-Savage, Alison Musgrove, Patricia Price, Wei Tan, Lucy Bradshaw, Alan Montgomery, Deborah Fitzsimmons, Angela Farr, Thomas Winfield, Ceri Phillips
BACKGROUND: Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. OBJECTIVE: To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. DESIGN: A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups...
May 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28643620/adult-dogs-are-capable-of-regulating-calcium-balance-with-no-adverse-effects-on-health-when-fed-a-high-calcium-diet
#13
Jonathan Stockman, Phillip Watson, Matthew Gilham, David Allaway, Jujhar Atwal, Richard Haydock, Alison Colyer, Helen Renfrew, Penelope J Morris
Although the implications of long-term high Ca intakes have been well documented in growing dogs, the health consequences of Ca excess in adult dogs remain to be established. To evaluate the impact of feeding a diet containing 7·1 g/4184 kJ (1000 kcal) Ca for 40 weeks on Ca balance and health parameters in adult dogs, eighteen neutered adult Labrador Retrievers, (nine males and nine females) aged 2·5-7·4 years were randomised to one of two customised diets for 40 weeks. The diets were manufactured according to similar nutritional specifications, with the exception of Ca and P levels...
May 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/28643215/relationship-between-instantaneous-wave-free-ratio-and-fractional-flow-reserve-in-patients-receiving-hemodialysis
#14
Yuta Morioka, Hiroyuki Arashi, Hisao Otsuki, Junichi Yamaguchi, Nobuhisa Hagiwara
Instantaneous wave-free ratio (iFR) is a vasodilator-free index and is reported to have a good correlation with fractional flow reserve (FFR). Hemodialysis patients exhibit left ventricular hypertrophy, reduced arterial compliance, and impaired microcirculation. Such a coronary flow condition in these patients may influence the relationship between iFR and FFR. This study assessed the impact of hemodialysis on the relationship between iFR and FFR. The study enrolled 196 patients with 265 stenoses who underwent assessment via iFR, FFR assessment, and right heart catheterization...
June 22, 2017: Cardiovascular Intervention and Therapeutics
https://www.readbyqxmd.com/read/28642997/pd-1-and-cancer-molecular-mechanisms-and-polymorphisms
#15
REVIEW
Arash Salmaninejad, Vahid Khoramshahi, Alireza Azani, Ehsan Soltaninejad, Saeed Aslani, Mohammad Reza Zamani, Masoud Zal, Abolfazl Nesaei, Sayed Mostafa Hosseini
The programmed cell death protein 1 (PD-1) is expressed by activated T cells that act as an immunoregulatory molecule, and are responsible for the negative regulation of T cell activation and peripheral tolerance. The PD-1 gene also encodes an inhibitory cell surface receptor involved in the regulation of T cell functions during immune responses/tolerance. Beyond potent inhibitory effects on T cells, PD-1 also has a role in regulating B cell and monocyte responses. An overexpression of PD-1 has been reported to contribute to immune system avoidance in different cancers...
June 22, 2017: Immunogenetics
https://www.readbyqxmd.com/read/28642208/assessing-the-efficacy-of-imagery-enhanced-cognitive-behavioral-group-therapy-for-social-anxiety-disorder-study-protocol-for-a-randomized-controlled-trial
#16
Peter M McEvoy, Michelle L Moulds, Jessica R Grisham, Emily A Holmes, David A Moscovitch, Delia Hendrie, Lisa M Saulsman, Ottmar V Lipp, Robert T Kane, Ronald M Rapee, Matthew P Hyett, David M Erceg-Hurn
Cognitive behavior group therapy (CBGT) is effective for social anxiety disorder (SAD), but a substantial proportion of patients do not typically achieve normative functioning. Cognitive behavioral models of SAD emphasize negative self-imagery as an important maintaining factor, and evidence suggests that imagery is a powerful cognitive mode for facilitating affective change. This study will compare two group CBGT interventions, one that predominantly uses verbally-based strategies (VB-CBGT) and another that predominantly uses imagery-enhanced strategies (IE-CBGT), in terms of (a) efficacy, (b) mechanisms of change, and (c) cost-effectiveness...
June 19, 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28641999/effect-of-pharmacist-care-on-medication-adherence-and-cardiovascular-outcomes-among-patients-post-acute-coronary-syndrome-a%C3%A2-systematic-review
#17
REVIEW
Maguy Saffouh El Hajj, Myriam Jihad Jaam, Ahmed Awaisu
BACKGROUND: The impact of collaborative and multidisciplinary health care on the outcomes of care in patients with acute coronary syndromes (ACS) is well-established in the literature. However, there is lack of high quality evidence on the role of pharmacist care in this setting. OBJECTIVE: This systematic review aimed to evaluate the impact of pharmacist care on patient outcomes (readmission, mortality, emergency visits, and medication adherence) in patients with ACS at or post-discharge...
June 13, 2017: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/28641991/vitality-training-a-mindfulness-and-acceptance-based-intervention-for-chronic-pain
#18
Heidi A Zangi, Liv Haugli
Chronic non-malign pain has a substantial impact on all parts of an individual's life. Mindfulness- and acceptance- based interventions are increasingly offered to help people manage their pain and strengthening their health promoting resources. In this paper, we present a mindfulness- and acceptance-based intervention, the Vitality Training Programme (VTP), to mitigating pain and accompanying symptoms and increasing pain coping abilities. Based on a clinical case presentation, we discuss how the VTP can help individuals to live a better life with pain...
June 9, 2017: Patient Education and Counseling
https://www.readbyqxmd.com/read/28641842/long-term-clinical-outcomes-of-patients%C3%A2-treated-with-everolimus-eluting-bioresorbable-stents-in-routine-practice-2-year-results-of-the-isar-absorb-registry
#19
Jens Wiebe, Petra Hoppmann, Roisin Colleran, Sebastian Kufner, Michael Valeskini, Salvatore Cassese, Simon Schneider, Michael Joner, Heribert Schunkert, Karl-Ludwig Laugwitz, Adnan Kastrati, Robert A Byrne
OBJECTIVES: The aim of this study was to report clinical outcomes in patients treated in routine practice 2 years after everolimus-eluting bioresorbable stent (BRS) implantation. BACKGROUND: Long-term results in patients undergoing BRS implantation in routine clinical practice are sparse, and existing evidence from randomized trials considers mostly selected patients. METHODS: The ISAR-ABSORB registry enrolled consecutive patients undergoing BRS implantation in routine clinical practice at 2 high-volume centers in Germany...
June 26, 2017: JACC. Cardiovascular Interventions
https://www.readbyqxmd.com/read/28641749/congenital-diaphragmatic-hernia-the-role-of-multi-institutional-collaboration-and-patient-registries-in-supporting-best-practice
#20
Pamela A Lally, Erik D Skarsgard
Among congenital malformations, congenital diaphragmatic hernia (CDH) is distinguished by its relatively low occurrence rate, need for resource intensive, integrated multidisciplinary care, and widespread variation in practice and outcome. Although randomized controlled trials (RCTs) are considered the gold standard for generating evidence, they are poorly suited to the study of a condition like CDH due to challenges in illness severity adjustment, unpredictability in clinical course and the impact limitations of studying a single intervention at a time...
June 2017: Seminars in Pediatric Surgery
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