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https://www.readbyqxmd.com/read/29684832/effect-of-non-nutritive-sucking-and-sucrose-alone-and-in-combination-for-repeated-procedural-pain-in-preterm-infants-a-randomized-controlled-trial
#1
Haixia Gao, Mei Li, Honglian Gao, Guihua Xu, Fang Li, Jing Zhou, Yunsu Zou, Honghua Jiang
BACKGROUND: Sucrose combined with non-nutritive sucking provided better pain relief than sucrose or non-nutritive sucking alone in a single painful procedure. However, whether the combination of non-nutritive sucking with sucrose could obtain a significant difference in analgesic effect of the repeated procedural pain than any single intervention has not been established. OBJECTIVE: To compare the effect of non-nutritive sucking and sucrose alone and in combination of repeated procedural pain in preterm infants...
April 7, 2018: International Journal of Nursing Studies
https://www.readbyqxmd.com/read/29684633/efficacy-of-a-carrageenan-gel-against-transmission-of-cervical-hpv-catch-interim-analysis-of-a-randomized-double-blind-placebo-controlled-phase-2b-trial
#2
Sindy Magnan, Joseph E Tota, Mariam El-Zein, Ann N Burchell, John T Schiller, Alex Ferenczy, Pierre-Paul Tellier, François Coutlée, Eduardo L Franco
OBJECTIVE: We evaluated the efficacy of a carrageenan-based lubricant gel in reducing the risk of genital human papillomavirus (HPV) infections in women. METHODS: We conducted a planned interim analysis of a randomized, double-blind, placebo-controlled, phase 2B trial. Women aged 18 years and older were randomly assigned (1:1) to a carrageenan-based or a placebo gel to be self-applied every other day for the first month and prior to and following each intercourse during follow-up...
April 20, 2018: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/29684433/oxygen-titration-after-resuscitation-from-out-of-hospital-cardiac-arrest-a-multi-centre-randomised-controlled-pilot-study-the-exact-pilot-trial
#3
Janet E Bray, Cindy Hein, Karen Smith, Michael Stephenson, Hugh Grantham, Judith Finn, Dion Stub, Peter Cameron
INTRODUCTION: Recent studies suggest the administration of 100% oxygen to hyperoxic levels following return-of-spontaneous-circulation (ROSC) post-cardiac arrest may be harmful. However, the feasibility and safety of oxygen titration in the prehospital setting is unknown. We conducted a multi-centre, phase-2 study testing whether prehospital titration of oxygen results in an equivalent number of patients arriving at hospital with oxygen saturations SpO2 ≥ 94%. METHODS: We enrolled unconscious adults with: sustained ROSC; initial shockable rhythm; an advanced airway; and an SpO2 ≥ 95%...
April 20, 2018: Resuscitation
https://www.readbyqxmd.com/read/29684049/clinical-factors-associated-with-early-progression-and-grade-3-4-toxicity-in-patients-with-advanced-non-small-cell-lung-cancers-treated-with-nivolumab
#4
Coraline Dumenil, Marie-Ange Massiani, Jennifer Dumoulin, Violaine Giraud, Sylvie Labrune, Thierry Chinet, Etienne Giroux Leprieur
INTRODUCTION: The prognosis of advanced non-small-cell lung cancer (NSCLC) has been improved by development of immune checkpoint inhibitors (ICIs) such as nivolumab for second-line treatment. As phase III trials include only selected patients, we here investigated the clinical factors associated with efficacy and safety of nivolumab in 'real life' patients with advanced NSCLC. METHODS: Clinical and histological characteristics, therapies and survival data of all consecutive patients with advanced NSCLC included prospectively and treated by nivolumab in two French academic hospitals between February 2015 and December 2016 were examined...
2018: PloS One
https://www.readbyqxmd.com/read/29683943/pentoxifylline-added-to-steroid-window-treatment-phase-modified-apoptotic-gene-expression-in-pediatric-patients-with-acute-lymphoblastic-leukemia
#5
Jesus Meza-Arroyo, Alejandro Bravo-Cuellar, Luis Felipe Jave-Suárez, Georgina Hernández-Flores, Pablo Ortiz-Lazareno, Adriana Aguilar-Lemarroy, Marlin Padilla-Corona, Fernando Sanchez-Zubieta, Oscar Gonzalez-Ramella
Pentoxifylline is a xanthine that possesses antitumor properties and that can induce higher apoptosis in the leukemic cells of pediatric patients with acute lymphoblastic leukemia (ALL) during treatment with prednisone. We conducted a phase 1 pilot, controlled, randomized trial to evaluate the gene expression modified by pentoxifylline during the steroid window of induction to remission phase in patients newly diagnosed with ALL. Experimental and control treatments induced broad changes in the gene expression profile...
April 20, 2018: Journal of Pediatric Hematology/oncology
https://www.readbyqxmd.com/read/29683855/a-week-48-randomized-phase-3-trial-of-darunavir-cobicistat-emtricitabine-tenofovir-alafenamide-in-treatment-na%C3%A3-ve-hiv-1-patients
#6
Joseph J Eron, Chloe Orkin, Joel Gallant, Jean-Michel Molina, Eugenia Negredo, Andrea Antinori, Anthony Mills, Jacques Reynes, Erika Van Landuyt, Erkki Lathouwers, Veerle Hufkens, John Jezorwski, Simon Vanveggel, Magda Opsomer
OBJECTIVES: To investigate efficacy and safety of a single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg vs. darunavir/cobicistat plus emtricitabine/tenofovir disoproxyl fumarate (TDF) (control) in antiretroviral-treatment-naïve, HIV-1-infected adults. DESIGN: Phase-3, randomized, active-controlled, double-blind, international, multicenter, noninferiority study (NCT02431247). METHODS: Seven hundred and twenty-five participants were randomized (1 : 1) to D/C/F/TAF (362) or control (363)...
April 19, 2018: AIDS
https://www.readbyqxmd.com/read/29683790/multicenter-phase-ib-trial-of-carboxyamidotriazole-orotate-and-temozolomide-for-recurrent-and-newly-diagnosed-glioblastoma-and-other-anaplastic-gliomas
#7
Antonio Omuro, Kathryn Beal, Katharine McNeill, Robert J Young, Alissa Thomas, Xuling Lin, Robert Terziev, Thomas J Kaley, Lisa M DeAngelis, Mariza Daras, Igor T Gavrilovic, Ingo Mellinghoff, Eli L Diamond, Andrew McKeown, Malbora Manne, Andrew Caterfino, Krishna Patel, Linda Bavisotto, Greg Gorman, Michael Lamson, Philip Gutin, Viviane Tabar, Debyani Chakravarty, Timothy A Chan, Cameron W Brennan, Elizabeth Garrett-Mayer, Rashida A Karmali, Elena Pentsova
Purpose Carboxyamidotriazole orotate (CTO) is a novel oral inhibitor of non-voltage-dependent calcium channels with modulatory effects in multiple cell-signaling pathways and synergistic effects with temozolomide (TMZ) in glioblastoma (GBM) models. We conducted a phase IB study combining CTO with two standard TMZ schedules in GBM. Methods In cohort 1, patients with recurrent anaplastic gliomas or GBM received escalating doses of CTO (219 to 812.5 mg/m2 once daily or 600 mg fixed once-daily dose) combined with TMZ (150 mg/m2 5 days during each 28-day cycle)...
April 23, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29683474/antidepressants-for-the-treatment-of-depression-in-people-with-cancer
#8
REVIEW
Giovanni Ostuzzi, Faith Matcham, Sarah Dauchy, Corrado Barbui, Matthew Hotopf
BACKGROUND: Major depression and other depressive conditions are common in people with cancer. These conditions are not easily detectable in clinical practice, due to the overlap between medical and psychiatric symptoms, as described by diagnostic manuals such as the Diagnostic and Statistical Manual of Mental Disorders (DSM) and International Classification of Diseases (ICD). Moreover, it is particularly challenging to distinguish between pathological and normal reactions to such a severe illness...
April 23, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29682899/generalization-and-representativeness-of-phase-iii-immune-checkpoint-blockade-trials-in-non-small-cell-lung-cancer
#9
Shin Hye Yoo, Bhumsuk Keam, Miso Kim, Tae Min Kim, Dong-Wan Kim, Dae Seog Heo
BACKGROUND: Strict eligibility criteria for patient enrollment in phase III trials raise questions regarding generalization to ineligible patients. We evaluated whether pivotal phase III trials of immune checkpoint blockades (ICBs) represent the overall population of non-small cell lung cancer (NSCLC) patients. METHODS: We reviewed the inclusion and exclusion criteria of three phase III trials (CheckMate057, CheckMate017, and KEYNOTE-010). Stage IIIB or IV NSCLC patients diagnosed from 2011 to 2013 at Seoul National University Hospital (cohort 1) were reviewed...
April 22, 2018: Thoracic Cancer
https://www.readbyqxmd.com/read/29682483/discovering-a-reliable-heat-shock-factor-1-inhibitor-to-treat-human-cancers-potential-opportunity-for-phytochemists
#10
Murugesan Velayutham, Arturo J Cardounel, Zhenguo Liu, Govindasamy Ilangovan
Heat-shock factor-1 (HSF-1) is an important transcription factor that regulates pathogenesis of many human diseases through its extensive transcriptional regulation. Especially, it shows pleiotropic effects in human cancer, and hence it has recently received increased attention of cancer researchers. After myriad investigations on HSF-1, the field has advanced to the phase where there is consensus that finding a potent and selective pharmacological inhibitor for this transcription factor will be a major break-through in the treatment of various human cancers...
2018: Frontiers in Oncology
https://www.readbyqxmd.com/read/29682332/gender-and-outcomes-in-non-small-cell-lung-cancer-an-old-prognostic-variable-comes-back-for-targeted-therapy-and-immunotherapy
#11
Joseph A Pinto, Carlos S Vallejos, Luis E Raez, Luis A Mas, Rossana Ruiz, Junior S Torres-Roman, Zaida Morante, Jhajaira M Araujo, Henry L Gómez, Alfredo Aguilar, Denisse Bretel, Claudio J Flores, Christian Rolfo
Background: There are well-known differences in gender outcome in non-small cell lung cancer (NSCLC) and other cancers. In this work, we evaluated several randomised clinical trials to explore the gender influence in the outcome of patients with NSCLC treated with targeted therapy and immunotherapy. Methods: We performed a series of meta-analysis to compare the gender outcome in the routine setting for overall survival and progression-free survival (PFS) in phase III randomised clinical trials comparing EGFR inhibitors versus chemotherapy (OPTIMAL, LUX-lung 3, LUX-lung 6, EURTAC, ENSURE and WTJOG); ALK inhibitors versus chemotherapy (ASCEND 4, ASCEND 5, PROFILE 1014 and NCT009323893) and anti-PD1 checkpoint inhibitors versus chemotherapy (CheckMate 017, CheckMate 026, CheckMate 057, KEYNOTE 010 and KEYNOTE 024)...
2018: ESMO Open
https://www.readbyqxmd.com/read/29681718/therapeutic-efficacy-of-endometrial-scratching-in-repeated-controlled-ovarian-stimulation-cos-failure-cycles
#12
Leena Wadhwa, Mona Mishra
Objective: The objective of the study was (1) "to evaluate the therapeutic efficacy of endometrial scratching in repeated controlled ovarian stimulation (COS) failure cycles." And (2) "to compare differences in pregnancy outcome by endometrial scratching in early (D2-D4) and late follicular phases (D7-D9) of the same stimulation cycle." Materials and Methods: Women attending infertility clinic in a tertiary care center and who have two or more repeated COS failure cycles and planned for COS with intrauterine insemination (IUI) were included in the study which is a prospective parallel, interventional, single-blinded, randomized control study, in 1:1 allocation ratio...
January 2018: Journal of Human Reproductive Sciences
https://www.readbyqxmd.com/read/29681462/the-onclarity-human-papillomavirus-trial-design-methods-and-baseline-results
#13
Mark H Stoler, Thomas C Wright, Valentin Parvu, Laurence Vaughan, Karen Yanson, Karen Eckert, Tobi Karchmer, Salma Kodsi, Charles K Cooper
OBJECTIVES: The baseline phase of the Onclarity trial was conducted to determine the screening performance of the Onclarity human papillomavirus (HPV) assay for detecting cervical cancer and precancer (≥CIN2) during triage of women ≥21 years with ASC-US cytology, as an adjunct test in women ≥30 years with normal cytology and for primary screening (HPV alone) in women ≥25 years. METHODS: 33,858 women ≥21 years were enrolled during routine clinic visits...
April 19, 2018: Gynecologic Oncology
https://www.readbyqxmd.com/read/29681434/a-placebo-controlled-phase-ii-study-of-ruxolitinib-in-combination-with-pemetrexed-and-cisplatin-for-first-line-treatment-of-patients-with-advanced-nonsquamous-non-small-cell-lung-cancer-and-systemic-inflammation
#14
Giuseppe Giaccone, Rachel E Sanborn, Saiama N Waqar, Alex Martinez-Marti, Santiago Ponce, Huiling Zhen, Gerard Kennealey, Susan Erickson-Viitanen, Eric Schaefer
BACKGROUND: Dysregulation of the Janus kinase (JAK)/signal transducers and activators of transcription pathway contributes to abnormal inflammatory responses and poor prognosis in non-small-cell lung cancer (NSCLC). We evaluated the JAK1/JAK2 inhibitor ruxolitinib plus pemetrexed/cisplatin first-line in patients with stage IIIB/IV or recurrent nonsquamous NSCLC with systemic inflammation (modified Glasgow prognostic score [mGPS] 1/2). PATIENTS AND METHODS: Part 1 was an open-label, safety run-in, in which we assessed ruxolitinib (15 mg twice daily [b...
March 23, 2018: Clinical Lung Cancer
https://www.readbyqxmd.com/read/29680419/a-randomised-controlled-trial-of-bright-light-therapy-and-morning-activity-for-adolescents-and-young-adults-with-delayed-sleep-wake-phase-disorder
#15
C Richardson, N Cain, K Bartel, G Micic, B Maddock, M Gradisar
A randomised controlled trial evaluated bright light therapy and morning activity for the treatment of Delayed Sleep-Wake Phase Disorder (DSWPD) in young people. 60 adolescents and young adults (range = 13-24 years, mean = 15.9 ± 2.2 y, 63% f) diagnosed with DSWPD were randomised to receive three weeks of post-awakening Green Bright Light Therapy (∼507 nm) and Sedentary Activity (sitting, watching TV), Green Bright Light Therapy and Morning Activity (standing, playing motion-sensing videogame), Red Light Therapy (∼643 nm) and Sedentary Activity or Red Light Therapy and Morning Activity...
May 2018: Sleep Medicine
https://www.readbyqxmd.com/read/29680321/preoperative-radiotherapy-and-local-excision-of-rectal-cancer-long-term-results-of-a-randomised-study
#16
Przemysław Wawok, Wojciech Polkowski, Piotr Richter, Marek Szczepkowski, Janusz Olędzki, Ryszard Wierzbicki, Tomasz Gach, Andrzej Rutkowski, Adam Dziki, Leszek Kołodziejski, Rafał Sopyło, Lucyna Pietrzak, Jacek Kryński, Katarzyna Wiśniowska, Mateusz Spałek, Konrad Pawlewicz, Marcin Polkowski, Teresa Kowalska, Krzysztof Paprota, Małgorzata Jankiewicz, Andrzej Radkowski, Justyna Chalubińska-Fendler, Wojciech Michalski, Krzysztof Bujko
BACKGROUND AND PURPOSE: It is uncertain whether local control is acceptable after preoperative radiotherapy and local excision (LE). An optimal preoperative dose/fractionation schedule has not yet been established. MATERIAL AND METHODS: In a phase III study, patients with cT1-2N0M0 or borderline cT2/T3N0M0 < 4 cm rectal adenocarcinomas were randomised to receive either 5 × 5 Gy plus 1 × 4 Gy boost or chemoradiation: 50.4 Gy in 28 fractions plus 3 × 1...
April 18, 2018: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29680317/a-double-blind-placebo-controlled-phase-ii-randomised-cross-over-trial-investigating-the-use-of-duloxetine-for-the-treatment-of-chemotherapy-induced-peripheral-neuropathy
#17
Eva Battaglini, Susanna B Park, Elizabeth H Barnes, David Goldstein
BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) is a significant side effect of cancer treatment, potentially leading to early cessation of chemotherapy, enduring symptoms and long-lasting disability. Evidence from preclinical and clinical studies suggests that duloxetine, a serotonin-noradrenaline reuptake inhibitor, may be effective in the symptomatic treatment of CIPN. This double blind, placebo controlled, phase II randomised cross-over trial aims to determine whether treatment with duloxetine results in a reduction in chronic neuropathic symptoms experienced as a result of neurotoxic chemotherapy treatment...
April 19, 2018: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/29680193/phase-ii-study-of-paclitaxel-and-dasatinib-in-metastatic-breast-cancer
#18
Patrick G Morris, Selene Rota, Karen Cadoo, Stephen Zamora, Sujata Patil, Gabriella D'Andrea, Theresa Gilewski, Jacqueline Bromberg, Chau Dang, Maura Dickler, Shanu Modi, Andrew D Seidman, Nancy Sklarin, Larry Norton, Clifford A Hudis, Monica N Fornier
BACKGROUND: Overexpression and activation of tyrosine kinase Src has been linked to breast carcinogenesis and bone metastases. We showed the feasibility of combining the SRC inhibitor dasatinib with weekly paclitaxel in patients with metastatic breast cancer (MBC) and herein report the subsequent phase II trial. PATIENTS AND METHODS: Patients had received ≤ 2 chemotherapy regimens for measurable, HER2-negative MBC. Patients received paclitaxel and dasatinib (120 mg daily) and were assessed according to Response Evaluation Criteria in Solid Tumors for overall response rate (ORR), the primary end point...
March 15, 2018: Clinical Breast Cancer
https://www.readbyqxmd.com/read/29679691/newly-developed-endoscopic-detachable-snare-ligation-therapy-for-colonic-diverticular-hemorrhage-a-multicenter-phase-ii-trial-with-videos
#19
Daisuke Akutsu, Toshiaki Narasaka, Katsumasa Kobayashi, Kenji Matsuda, Mariko Wakayama, Yoshinori Hiroshima, Shinji Endo, Takashi Mamiya, Takahisa Watahiki, Kazuto Ikezawa, Hiroyasu Ishida, Mitsuaki Hirose, Yuji Mizokami, Ichinosuke Hyodo
BACKGROUND AND AIMS: We previously reported preliminary safety results for a new method, endoscopic detachable snare ligation (EDSL), for diverticular hemorrhage. This method does not need endoscope removal to attach a ligation device after detection of the bleeding site. The aim of the present study was to evaluate the efficacy and safety of EDSL in a larger patient population. METHODS: This prospective study was conducted in 12 institutions. Patients suspected of having diverticular hemorrhage without serious systemic disease were enrolled...
April 18, 2018: Gastrointestinal Endoscopy
https://www.readbyqxmd.com/read/29678987/protocol-for-a-phase-iii-non-inferiority-randomised-comparison-of-a-new-fibrinogen-concentrate-versus-cryoprecipitate-for-treating-acquired-hypofibrinogenaemia-in-bleeding-cardiac-surgical-patients-the-fibres-trial
#20
Keyvan Karkouti, Jeannie Callum, Vivek Rao, Nancy Heddle, Michael E Farkouh, Mark A Crowther, Damon C Scales
INTRODUCTION: Coagulopathic bleeding is a serious complication of cardiac surgery to which an important contributor is acquired hypofibrinogenaemia (plasma fibrinogen <1.5-2.0 g/L). The standard intervention for acquired hypofibrinogenaemia is cryoprecipitate, but purified fibrinogen concentrates are also available. There is little comparative data between the two therapies and randomised trials are needed. METHODS AND ANALYSIS: FIBrinogen REplenishment in Surgery (FIBRES) is a multicentre, randomised (1:1), active-control, single-blinded, phase III trial in adult cardiac surgical patients experiencing clinically significant bleeding related to acquired hypofibrinogenaemia...
April 20, 2018: BMJ Open
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