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Controlled clinical trial

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https://www.readbyqxmd.com/read/28927211/a-pivotal-randomized-clinical-trial-evaluating-the-safety-and-effectiveness-of-a-novel-hydrogel-dural-sealant-as-an-adjunct-to-dural-repair
#1
Michael J Strong, G Alexander West, Henry Woo, Daniel E Couture, John A Wilson, Lorenzo F Munoz, Charles L Rosen, Jeremy D Greenlee, Harry R van Loveren, Mark Iantosca, Clinton J Baird, Mark Smith, Matt McGirt, Jonathan Parish, Anthony L Asher
BACKGROUND: A watertight dural repair is critical to minimizing the risk of postoperative complications secondary to cerebrospinal fluid (CSF) leaks. OBJECTIVE: To evaluate the safety and efficacy of a novel hydrogel, Adherus Dural Sealant, when compared with control, DuraSeal Dural Sealant System, as an adjunct to standard methods of dural repair. METHODS: In this 17-center, prospective, randomized clinical trial designed as a noninferiority, single-blinded study, 124 patients received Adherus Dural Sealant (test sealant) and 126 received DuraSeal (control)...
April 1, 2017: Operative Neurosurgery (Hagerstown, Md.)
https://www.readbyqxmd.com/read/28927084/thalidomide-and-lenalidomide-for-recurrent-ovarian-cancer-a-systematic-review-of-the-literature
#2
Clemens B Tempfer, Beate Schultheis, Ziad Hilal, Askin Dogan, Günther A Rezniczek
The present review aimed to assess the safety and efficacy of thalidomide and lenalidomide, two immunomodulatory drugs with anti-angiogenic properties, in women with recurrent ovarian, fallopian tube, and primary peritoneal cancer. A systematic review of the literature was conducted whereby Medline and the Cochrane Central Register of Controlled Trials were searched using terms associated with thalidomide, lenalidomide, and recurrent ovarian, fallopian tube and primary peritoneal cancer. Published English language case reports, trials and studies that described the safety and efficacy of thalidomide or lenalidomide alone, or in combination with other drugs were reviewed...
September 2017: Oncology Letters
https://www.readbyqxmd.com/read/28926793/early-symptomatic-improvement-affects-treatment-outcome-in-a-study-of-major-depressive-disorder
#3
Steven D Targum
Early symptomatic improvement immediately following randomization can affect signal detection in clinical trials. The impact of early improvement of the Montgomery-Asberg depression rating scale (MADRS) on eventual treatment outcome was examined in a 6-week, double-blind, placebo-controlled trial of a putative antidepressant (CX157) versus placebo in depressed subjects with major depressive disorder (MDD) who had had an inadequate response to ongoing antidepressant treatment (NCT00739908). MADRS score changes within one week after randomization directly affected treatment outcome at the study endpoint (week 6)...
September 8, 2017: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/28926573/self-monitoring-of-blood-pressure-in-hypertension-a-systematic-review-and-individual-patient-data-meta-analysis
#4
Katherine L Tucker, James P Sheppard, Richard Stevens, Hayden B Bosworth, Alfred Bove, Emma P Bray, Kenneth Earle, Johnson George, Marshall Godwin, Beverly B Green, Paul Hebert, F D Richard Hobbs, Ilkka Kantola, Sally M Kerry, Alfonso Leiva, David J Magid, Jonathan Mant, Karen L Margolis, Brian McKinstry, Mary Ann McLaughlin, Stefano Omboni, Olugbenga Ogedegbe, Gianfranco Parati, Nashat Qamar, Bahman P Tabaei, Juha Varis, Willem J Verberk, Bonnie J Wakefield, Richard J McManus
BACKGROUND: Self-monitoring of blood pressure (BP) appears to reduce BP in hypertension but important questions remain regarding effective implementation and which groups may benefit most. This individual patient data (IPD) meta-analysis was performed to better understand the effectiveness of BP self-monitoring to lower BP and control hypertension. METHODS AND FINDINGS: Medline, Embase, and the Cochrane Library were searched for randomised trials comparing self-monitoring to no self-monitoring in hypertensive patients (June 2016)...
September 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28926440/epidural-labor-analgesia-fentanyl-dose-and-breastfeeding-success-a-randomized-clinical-trial
#5
Amy I Lee, Robert J McCarthy, Paloma Toledo, Mary Jane Jones, Nancy White, Cynthia A Wong
BACKGROUND: Breastfeeding is an important public health concern. High cumulative doses of epidural fentanyl administered for labor analgesia have been reported to be associated with early termination of breastfeeding. We tested the hypothesis that breastfeeding success is adversely influenced by the cumulative epidural fentanyl dose administered for labor analgesia. METHODS: The study was a randomized, double-blind, controlled trial of parous women at greater than 38 weeks gestation who planned to breastfeed, had successfully breastfed a prior infant, and who received neuraxial labor analgesia...
October 2017: Anesthesiology
https://www.readbyqxmd.com/read/28926423/a-noninterventional-multicenter-prospective-phase-iv-study-of-trabectedin-in-patients-with-advanced-soft-tissue-sarcoma
#6
Angela Buonadonna, Charlotte Benson, Jose Casanova, Bernd Kasper, Antonio López Pousa, Filomena Mazzeo, Thomas Brodowicz, Nicolas Penel
This prospective, noninterventional study is the first phase IV trial designed to evaluate trabectedin in patients with advanced soft tissue sarcoma in real-life clinical practice across Europe. To be included in the study, patients must have received more than or equal to one cycle of trabectedin and be currently on treatment. The primary endpoint was progression-free survival as defined by investigators. The secondary endpoints included objective response rate, disease control rate, time to progression and the growth modulation index (GMI), overall survival, and an assessment of the cancer-related symptoms and safety...
September 18, 2017: Anti-cancer Drugs
https://www.readbyqxmd.com/read/28926399/natural-killer-cells-in-hiv-1-infection-and-therapy
#7
Joanna Mikulak, Ferdinando Oriolo, Elisa Zaghi, Clara Di Vito, Domenico Mavilio
: Natural killer (NK) cells are important effectors of innate immunity playing a key role in the eradication and clearance of viral infections. Over the recent years, several studies have shown that HIV-1 pathologically changes NK cell homeostasis and hampers their antiviral effector functions. Moreover, high levels of chronic HIV-1 viremia markedly impair those NK cell regulatory features that normally regulate the cross-talks between innate and adaptive immune responses. These pathogenic events take place early in the infection and are associated with a pathologic redistribution of NK cell subsets that includes the expansion of anergic CD56 NK cells with an aberrant repertoire of activating and inhibitory receptors...
September 18, 2017: AIDS
https://www.readbyqxmd.com/read/28926323/-analysis-of-the-cochrane-review-anti-vascular-endothelial-growth-factor-for-prevention-of-postoperative-vitreous-cavity-hemorrhage-after-vitrectomy-for-proliferative-diabetic-retinopathy-cochrane-database-syst-rev-2015-8-cd008214
#8
David Cordeiro Sousa, Inês Leal, João Costa, António Vaz-Carneiro
Postoperative vitreous hemorrhage is a complication following vitrectomy for proliferative diabetic retinopathy, delaying visual recovery and making fundus examination and disease follow-up more difficult. Anti-vascular endothelial growth factor drugs such as bevacizumab, when injected in the vitreous cavity, reduce vascular proliferation and their use has been proposed to reduce the incidence of postoperative vitreous hemorrhage. The authors of this Cochrane systematic review evaluated all randomized controlled trials on the pre- or intraoperative use of anti-vascular endothelial growth factor to reduce postoperative vitreous hemorrhage occurrence after vitrectomy in patients with proliferative diabetic retinopathy...
August 31, 2017: Acta Médica Portuguesa
https://www.readbyqxmd.com/read/28926307/predictive-utility-of-personality-disorder-in-depression-comparison-of-outcomes-and-taxonomic-approach
#9
Giles Newton-Howes, Roger Mulder, Pete M Ellis, Joseph M Boden, Peter Joyce
There is debate around the best model for diagnosing personality disorder, both in terms of its relationship to the empirical data and clinical utility. Four randomized controlled trials examining various treatments for depression were analyzed at an individual patient level. Three different approaches to the diagnosis of personality disorder were analyzed in these patients. A total of 578 depressed patients were included in the analysis. Personality disorder, however measured, was of little predictive utility in the short term but added significantly to predictive modelling of medium-term outcomes, accounting for more than twice as much of the variance in social functioning outcome as depression psychopathology...
September 19, 2017: Journal of Personality Disorders
https://www.readbyqxmd.com/read/28926296/randomised-controlled-trial-of-urokinase-versus-placebo-for-non-draining-malignant-pleural-effusion
#10
Eleanor K Mishra, Amelia O Clive, Genevieve H Wills, Helen E Davies, Andrew E Stanton, Mohamed Al-Aloul, Alan Hart-Thomas, Justin Pepperell, Matthew Evison, Tarek Saba, Richard Neil Harrison, Anur Guhan, Matthew E Callister, Ramamurthy Sathyamurthy, Sunita Rehal, John P Corcoran, Robert Hallifax, Ioannis Psallidas, Nicky Russell, Rachel Shaw, Melissa Dobson, John M Wrightson, Alex West, Y C Gary Lee, Andrew J Nunn, Robert F Miller, Nick A Maskell, Najib M Rahman
RATIONALE: Patients with malignant pleural effusion (MPE) experience breathlessness, which is treated by drainage and pleurodesis. Incomplete drainage results in residual dyspnea and pleurodesis failure. Intrapleural fibrinolytics lyse septations within pleural fluid, improving drainage. OBJECTIVES: To assess the effects of intrapleural urokinase on dyspnea and pleurodesis success in patients with non-draining malignant effusion. METHODS: Prospective double blind randomised trial; patients with non-draining effusion were randomly allocated 1:1 to intrapleural urokinase (100,000 IU three doses 12 hourly) or matched placebo...
September 19, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28926295/efficacy-and-safety-assessment-of-acute-sports-related-traumatic-soft-tissue-injuries-using-a-new-ibuprofen-medicated-plaster-results-from-a-randomized-controlled-clinical-trial
#11
Hans-Georg Predel, Mark P Connolly, Aomesh Bhatt, Bruno Giannetti
OBJECTIVE: To investigate the efficacy and safety of a recently developed ibuprofen medicated plaster in the treatment of acute sports impact injuries/contusions. METHODS: In this double-blind, multi-center, placebo-controlled, parallel group, phase 3 study (EudraCT Number: 2012-003257-2) patients (n=132; ages 18 to 60 years) diagnosed with acute sports-related traumatic blunt soft tissue injury/contusion to the upper or lower limbs were randomized to receive either ibuprofen 200 mg plaster (n=64) or placebo plaster (n=68)...
September 19, 2017: Physician and Sportsmedicine
https://www.readbyqxmd.com/read/28926288/effect-of-inpatient-palliative-care-during-hematopoietic-stem-cell-transplant-on-psychological-distress-6-months-after-transplant-results-of-a-randomized-clinical-trial
#12
Areej El-Jawahri, Lara Traeger, Joseph A Greer, Harry VanDusen, Sarah R Fishman, Thomas W LeBlanc, William F Pirl, Vicki A Jackson, Jason Telles, Alison Rhodes, Zhigang Li, Thomas R Spitzer, Steven McAfee, Yi-Bin A Chen, Jennifer S Temel
Purpose Inpatient palliative care integrated with transplant care improves patients' quality of life (QOL) and symptom burden during hematopoietic stem-cell transplant (HCT). We assessed patients' mood, post-traumatic stress disorder (PTSD) symptoms, and QOL 6 months post-transplant. Methods We randomly assigned 160 patients with hematologic malignancies who underwent autologous or allogeneic HCT to inpatient palliative care integrated with transplant care (n = 81) or transplant care alone (n = 79). At baseline and 6 months post-transplant, we assessed mood, PTSD symptoms, and QOL with the Hospital Anxiety and Depression Scale and Patient Health Questionnaire, PTSD checklist, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant...
September 19, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28926159/randomized-controlled-feasibility-trial-of-intranasal-ketamine-compared-to-intranasal-fentanyl-for-analgesia-in-children-with-suspected-extremity-fractures
#13
Stacy L Reynolds, Kathleen K Bryant, Jonathan R Studnek, Melanie Hogg, Connell Dunn, Megan A Templin, Charity G Moore, James R Young, Katherine Rivera Walker, Michael S Runyon
OBJECTIVE: We compared the tolerability and efficacy of intranasal sub-dissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger non-inferiority trial that could investigate the potential opioid sparing effects of intranasal ketamine. METHODS: This randomized controlled trial compared intranasal ketamine 1 mg/kg to intranasal fentanyl 1.5 μg/kg in children 4-17 years old with acute pain from suspected, isolated extremity fractures presenting to an urban level II pediatric trauma center from December 2015 to November 2016...
September 19, 2017: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
https://www.readbyqxmd.com/read/28925876/the-antitumor-potential-of-marine-natural-products-a-mechanistic-investigation
#14
Liping Hu, Jie Ying, Miaomiao Zhang, Xiaoyan Qiu, Yu Lu
Compounds obtained from natural resources have been the important candidates for the discovery and development of drugs. Over the past few decades, marine resources gradually attracted the attention of the majority of researchers, and a number of compounds with various structures or activities have been obtained from sponge, alga, fungus, mollusks and some others. Because of the living conditions in the ocean are higher pressures, more variable temperatures, lower oxygen and lower light than that in the terrestrial environment, marine resources have a lot of organisms that are not available or rare on land...
September 18, 2017: Anti-cancer Agents in Medicinal Chemistry
https://www.readbyqxmd.com/read/28925467/effects-of-rosuvastatin-on-pentraxin-3-level-and-platelet-aggregation-rate-in-elderly-patients-with-acute-myocardial-infarction-undergoing-elective-interventional-therapy-a-double-blind-controlled-study
#15
Y-H Li, L-H Wang, Q Li, D-W Yu, Y-S Gai, S-X Cai, F Tian, H-Y Zhou
OBJECTIVE: To investigate clinical effects of rosuvastatin on blood lipid levels, hemorheological profiles, vascular endothelial function, pentraxin 3 (PTX-3) level, the number of granule membrane glycoprotein (GMP-140) molecules and platelet aggregation rate in elderly patients with acute myocardial infarction (AMI) undergoing elective percutaneous coronary intervention (PCI). PATIENTS AND METHODS: Total of 120 elderly patients admitted with AMI undergoing elective PCI from July 2014 to January 2016 were selected...
August 2017: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/28925169/-systematic-review-on-safety-of-salvianolate-injection
#16
Zhi-Wei Chen, Yan-Ming Xie, Xing Liao, Gui-Qian Wang
To systematically evaluate the safety of salvianolate injection in clinical medication. A systematic literature search was performed in the databases of Cochrane Library, Medline, Embase, the Web of Science, Clinical Trials, CNKI, VIP, WanFang Data and CBM. Literature screening was done according to inclusion and exclusion criteria, and quality was assessed according to internationally recognized quality evaluation criteria. Then the data were reviewed for analysis. 148 papers were included, consisting of 122 randomized controlled trials(RCTs), 10 non-randomized controlled trials(NRCTs), 4 case series studies, and 12 case reports...
October 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28925168/-meta-analysis-of-supplemented-zhenwu-decoction-for-treating-congestive-heart-failure
#17
Yuan-Ping Wang, Jie Xiong, Xia Yan, Xiao-Hui Li, Zi-Qing Luo
The paper was to systematically evaluate the clinical efficacy of supplemented Zhenwu decoction for treating congestive heart-failure. Three foreign language databases including the Cochrane Library, PubMed, EMbase and four Chinese databases including CBM, CNKI, VIP and Wanfang Database were retrieved from their establishment to July 2016 for all randomized control trials(RCTs) on supplemented Zhenwu decoction in treatment of congestive heart-failure. The references in the included RCTs were also traced. Literature selection and information extraction was completed and screened by two independent reviewers, and Meta-analysis was performed by using RevMan 5...
October 2016: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/28925009/efficacy-of-patients-preferred-exercise-modalities-in-chronic-obstructive-pulmonary-disease-a-parallel-group-randomized-clinical-trial
#18
Meng Wu, Lu-Qian Zhou, Shi Li, Su Zhao, Hui-Jun Fan, Jie-Min Sun, Xiao-Nan Li, Jian Luo, An-Qi Wang, Jian-Ping Wu, Xiaoying Li, Jin-Nong Zhang
INTRODUCTION: Physical exercise effectively improves health-related quality of life in patients with chronic obstructive pulmonary disease (COPD). However, application of this medical intervention is problematic, due to poor adherence to the exercise program or unawareness of the significance of this intervention. OBJECTIVE: To determine whether COPD patients who adopted personal-preferred exercise modalities (PPEMs) for daily training would demonstrate sustained benefits due to improved adherence...
September 19, 2017: Clinical Respiratory Journal
https://www.readbyqxmd.com/read/28924972/targeting-nociceptive-trp-channels-to-treat-chronic-pain-current-state-of-the-field
#19
REVIEW
Magdalene M Moran, Arpad Szallasi
Control of chronic pain is frequently inadequate and/or associated with intolerable adverse effects, prompting a frantic search for new therapeutics and new therapeutic targets. Nearly two decades of preclinical and clinical research supports the involvement of Transient Receptor Potential (TRP) channels in temperature perception, nociception and sensitization. Although there has been considerable excitement around the therapeutic potential of this channel family since the cloning and identification of TRPV1 as the capsaicin receptor more than 20 years ago, only modulators of a few channels have been tested clinically...
September 19, 2017: British Journal of Pharmacology
https://www.readbyqxmd.com/read/28924870/efficacy-of-a-novel-sigma-1-receptor-antagonist-for-oxaliplatin-induced-neuropathy-a-randomized-double-blind-placebo-controlled-phase-iia-clinical-trial
#20
Jordi Bruna, Sebastián Videla, Andreas A Argyriou, Roser Velasco, Jesús Villoria, Cristina Santos, Cristina Nadal, Guido Cavaletti, Paola Alberti, Chiara Briani, Haralabos P Kalofonos, Diego Cortinovis, Mariano Sust, Anna Vaqué, Thomas Klein, Carlos Plata-Salamán
This trial assessed the efficacy of MR309 (a novel selective sigma-1 receptor ligand previously developed as E-52862) in ameliorating oxaliplatin-induced peripheral neuropathy (oxaipn). A discontinuous regimen of MR309 (400 mg/day, 5 days per cycle) was tested in patients with colorectal cancer receiving FOLFOX in a phase II, randomized, double-blind, placebo-controlled, multicenter clinical trial. Outcome measures included changes in 24-week quantitative measures of thermal sensitivity and total neuropathy score...
September 18, 2017: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
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