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Clinical Drug studies

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https://www.readbyqxmd.com/read/29050397/the-antimyotonic-effect-of-lamotrigine-in-non-dystrophic-myotonias-a-double-blind-randomized-study
#1
Grete Andersen, Gitte Hedermann, Nanna Witting, Morten Duno, Henning Andersen, John Vissing
Mexiletine is the only drug with proven effect for treatment of non-dystrophic myotonia, but mexiletine is expensive, has limited availability and several side effects. There is therefore a need to identify other pharmacological compounds that can alleviate myotonia in non-dystrophic myotonias. Like mexiletine, lamotrigine is a sodium channel blocker, but unlike mexiletine, lamotrigine is available, inexpensive, and well tolerated. We investigated the potential of using lamotrigine for treatment of myotonia in patients with non-dystrophic myotonias...
September 1, 2017: Brain: a Journal of Neurology
https://www.readbyqxmd.com/read/29050316/pharmacokinetics-and-drug-drug-interaction-between-enalapril-enalaprilat-and-felodipine-extended-release-er-in-healthy-subjects
#2
Dai Li, Sumei Xu, Yulu Wang, Dan Li, Xiaomin Li, Jing Pan, Pingsheng Xu
Since angiotensin-converting enzyme (ACE) inhibitors and calcium antagonists have complimentary mechanisms of action, enalapril, an ACE inhibitor, is used in combination with felodipine, a vascular selective dihydropyridine calcium antagonist, for the treatment of hypertension. The present study was designed to investigate the possible drug-drug interaction between these two agents in Chinese healthy subjects. A randomized, open-label, multiple-dose, 3-treatment, 3-period, 6-sequence cross-over study enrolling 12 healthy subjects (six male and six female subjects) was performed...
September 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29050241/combination-treatment-with-rucaparib-rubraca-and-mdm2-inhibitors-nutlin-3-and-rg7388-has-synergistic-and-dose-reduction-potential-in-ovarian-cancer
#3
Maryam Zanjirband, Nicola Curtin, Richard J Edmondson, John Lunec
Ovarian cancer is the seventh most common cancer worldwide for females and the most lethal of all gynecological malignancies. The treatment of ovarian cancer remains a challenge in spite of advances in debulking surgery and changes in both chemotherapy schedules and routes of administration. Cancer treatment has recently been improving with the introduction of targeted therapies to achieve greater specificity and less cytotoxicity. Both PARP inhibitors and MDM2-p53 binding antagonists are targeted therapeutic agents entered into clinical trials...
September 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29050204/irreversible-growth-plate-fusions-in-children-with-medulloblastoma-treated-with-a-targeted-hedgehog-pathway-inhibitor
#4
Giles W Robinson, Sue C Kaste, Wassim Chemaitilly, Daniel C Bowers, Stephen Laughton, Amy Smith, Nicholas G Gottardo, Sonia Partap, Anne Bendel, Karen D Wright, Brent A Orr, William C Warner, Arzu Onar-Thomas, Amar Gajjar
The permanent defects in bone growth observed in preclinical studies of hedgehog (Hh) pathway inhibitors were not substantiated in early phase clinical studies of vismodegib in children. Consequently, vismodegib advanced into pediatric trials for malignancies suspected of being driven by aberrant activation of the Hh pathway. In one multicenter phase II trial, vismodegib was added to the therapy regimen for newly diagnosed Hh pathway activated medulloblastoma. Herein, we report on 3 children (2 on trial and one off trial) treated with vismodegib who developed widespread growth plate fusions that persist long after cessation of therapy...
September 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29050116/-correlation-study-of-blood-drug-concentration-and-nephrotoxicity-on-high-dose-methotrexate-therapy-in-suggestion-of-diagnosis-and-treatment-of-childhood-acute-lymphoblastic-leukemia-in-the-4th-revised-edition
#5
D H Cheng, H Lu, X Q Zou
Objective: To explore the influence of the 4th revised treatment recommendations in childhood acute lymphoblastic leukemia (ALL) on high dose methotrexate(HD-MTX)-induced nephrotoxicity and MTX blood concentrations. Method: The clinical data from 330 ALL children who received 1 242 courses of HD-MTX therapies from September 2012 to November 2016 was collected. The courses were divided into two groups based on the chemotherapies: original scheme group was treated with the 3rd revised regimen, and new scheme group was treated with the 4th revised regimen...
October 2, 2017: Zhonghua Er Ke za Zhi. Chinese Journal of Pediatrics
https://www.readbyqxmd.com/read/29049872/optimal-dosing-and-delivery-of-pth-and-its-analogues-for-osteoporosis-and-hypoparathyroidism-translating-the-pharmacology
#6
REVIEW
D Tay, S Cremers, J P Bilezikian
In primary hyperparathyroidism (PHPT), bone loss results from the resorptive effects of excess parathyroid hormone (PTH). Under physiological conditions, PTH has actions that are more targeted to homeostasis and to bone accrual. The predominant action of PTH, either catabolic, anabolic, or homeostatic, can be understood in molecular and pharmacokinetic terms. When administered intermittently, PTH increases bone mass, but when present continuously and in excess (e.g., PHPT), bone loss ensues. This dual effect of PTH depends not only on the dosing regimen, continuous or intermittent, but also on how the PTH molecule interacts with various states of its receptor (PTH/PTHrP receptor) influencing downstream signaling pathways differentially...
October 19, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29049615/current-trends-in-management-of-submental-liposis-a-pooled-analysis-and-survey
#7
Sagar Patel, Russell Kridel
Importance: Since its approval by the US Food and Drug Administration for treatment of moderate to severe submental liposis in April 2015, deoxycholic acid (Kybella) has received significant media attention as a novel aesthetic treatment. Four phase 3 clinical trials have published data demonstrating the safety and efficacy of the drug compared with placebo; however, no study has juxtaposed the product with submental liposuction. Objective: To evaluate the efficacy of injectable deoxycholic acid in the treatment of isolated submental liposis...
October 19, 2017: JAMA Facial Plastic Surgery
https://www.readbyqxmd.com/read/29049540/feasibility-process-and-outcomes-of-cardiovascular-clinical-trial-data-sharing-a-reproduction-analysis-of-the-smart-af-trial
#8
Hawkins C Gay, Abigail S Baldridge, Mark D Huffman
Importance: Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise. Objective: To evaluate the feasibility, process, and outcomes of a reproduction analysis of the THERMOCOOL SMARTTOUCH Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (SMART-AF) trial using shared clinical trial data. Design, Setting, and Participants: A reproduction analysis of the SMART-AF trial was performed using the data sets, data dictionary, case report file, and statistical analysis plan from the original trial accessed through the Yale Open Data Access Project using the SAS Clinical Trials Data Transparency platform...
October 18, 2017: JAMA Cardiology
https://www.readbyqxmd.com/read/29049482/a-test-of-the-transdiagnostic-dopamine-hypothesis-of-psychosis-using-positron-emission-tomographic-imaging-in-bipolar-affective-disorder-and-schizophrenia
#9
Sameer Jauhar, Matthew M Nour, Mattia Veronese, Maria Rogdaki, Ilaria Bonoldi, Matilda Azis, Federico Turkheimer, Philip McGuire, Allan H Young, Oliver D Howes
Importance: The dopamine hypothesis suggests that dopamine abnormalities underlie psychosis, irrespective of diagnosis, implicating dopamine dysregulation in bipolar affective disorder and schizophrenia, in line with the research domain criteria approach. However, this hypothesis has not been directly examined in individuals diagnosed with bipolar disorder with psychosis. Objectives: To test whether dopamine synthesis capacity is elevated in bipolar disorder with psychosis and how this compares with schizophrenia and matched controls and to examine whether dopamine synthesis capacity is associated with psychotic symptom severity, irrespective of diagnostic class...
October 11, 2017: JAMA Psychiatry
https://www.readbyqxmd.com/read/29049402/upward-trends-of-acquired-drug-resistances-in-ethiopian-hiv-1c-isolates-a-decade-longitudinal-study
#10
Andargachew Mulu, Melanie Maier, Uwe Gerd Liebert
BACKGROUND: The emergence, accumulation and spread of HIV-1 drug resistance strains in Africa could compromise the effectiveness of HIV treatment programs. This study was aimed at determining the incidence of virological failure and acquired drug resistance mutations overtime and identifying the most common mutational pathways of resistance in a well characterized HIV-1C infected Ethiopian cohort. METHODS: A total of 320 patients (220 ART naïve and 100 on first lines ART) were included and followed...
2017: PloS One
https://www.readbyqxmd.com/read/29049253/clinical-efficacy-analysis-of-ahmed-glaucoma-valve-implantation-in-neovascular-glaucoma-and-influencing-factors-a-strobe-compliant-article
#11
Ye He, Ying Tian, Weitao Song, Ting Su, Haibo Jiang, Xiaobo Xia
This study aimed to evaluate the efficacy of Ahmed glaucoma valve (AGV) implantation in treating neovascular glaucoma (NVG) and to analyze the factors influencing the surgical success rate.This is a retrospective review of 40 eyes of 40 NVG patients who underwent AGV implantation at Xiangya Hospital of Central South University, China, between January 2014 and December 2016. Pre- and postoperative intraocular pressure (IOP), visual acuity, surgical success rate, medications, and complications were observed. Surgical success criteria were defined as IOP ≤21 and >6 mm Hg with or without additional medications...
October 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29049213/clinical-characteristics-and-prognostic-risk-factors-of-healthcare-associated-pneumonia-in-a-korean-tertiary-teaching-hospital
#12
June H Ahn, Kwan H Lee, Jin H Chung, Kyeong-Cheol Shin, Choong K Lee, Hyun Jung Kim, Eun Young Choi
The 2016 American Thoracic Society and Infectious Diseases Society of America (ATS/IDSA) guidelines removed the concept of healthcare-associated pneumonia (HCAP). We examined whether the 2016 ATS/IDSA guidelines are applicable in Korea.We conducted a retrospective, observational study of pneumonia patients who were hospitalized at a tertiary teaching hospital from March 2012 to February 2014. Identified pathogens that were not susceptible to β-lactams, macrolides, and fluoroquinolones were defined as community-acquired pneumonia drug-resistant pathogens (CAP-DRPs)...
October 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29049193/efficacy-and-safety-of-immunomodulatory-drugs-in-patients-with-anterior-uveitis-a-systematic-literature-review
#13
Alejandro Gómez-Gómez, Estíbaliz Loza, Maria Piedad Rosario, Gerard Espinosa, José M García Ruiz de Morales, Jose M Herreras, Santiago Muñoz-Fernández, Miguel Cordero-Coma
BACKGROUND: To assess the efficacy and safety of immunomodulatory drugs in patients with noninfectious anterior uveitis (AU). METHODS: Systematic review of studies were retrieved from Medline (1961 to March 2016), Embase (1961 to March 2016), and Cochrane Library (up to March 2016), and a complementary hand search was also performed. The selection criteria were as follows: (population) noninfectious AU patients, adults; (intervention) immunomodulatory drugs (any dose, regimen, route of administration, duration of treatment); (outcome) control of inflammation, steroid-sparing effect, AU flares, adverse events, and so on; (study design) systematic literature reviews, randomized controlled trials, and observational studies...
October 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29049178/evaluation-of-smoking-cessation-intervention-in-patients-with-chronic-diseases-in-smoking-cessation-clinics
#14
Changxi Zhou, Lei Wu, Qinghui Liu, Huaijie An, Bin Jiang, Fan Zuo, Li Zhang, Yao He
This study aimed to evaluate the effects of psychological intervention and psychological plus drug intervention on smoking cessation among male smokers with single chronic diseases.A total of 509 male smokers were divided into psychological group (n = 290) and psychological plus drugs (n = 219) groups according to their will. The physicians provided free individual counseling and follow-up interviews with brief counseling for all the subjects. In addition to mental intervention, patients in psychological plus drug group also received bupropion hydrochloride or varenicline tartrate to quit smoking...
October 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29049120/a-contemporary-medicolegal-analysis-of-outpatient-medication-management-in-chronic-pain
#15
Christopher R Abrecht, Ethan Y Brovman, Penny Greenberg, Ellen Song, James P Rathmell, Richard D Urman
BACKGROUND: Opioids are frequently used in chronic pain management but are associated with significant morbidity and mortality in some patient populations. An important avenue for identifying complications-including serious or rare complications-is the study of closed malpractice claims. The present study is intended to complement the existing closed claims literature by drawing on claims from a more recent timeframe through a partnership with a large malpractice carrier, the Controlled Risk Insurance Company (CRICO)...
November 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/29049110/evidence-for-the-efficacy-of-systemic-opioid-sparing-analgesics-in-pediatric-surgical-populations-a-systematic-review
#16
Alyssa Zhu, Hubert A Benzon, T Anthony Anderson
While a large number of studies has examined the efficacy of opioid-sparing analgesics in adult surgical populations, fewer studies are available to guide postoperative pain treatment in pediatric patients. We systematically reviewed available publications on the use of systemic nonopioid agents for postoperative analgesia in pediatric surgical populations. A comprehensive literature search identified meta-analyses and randomized controlled trials (RCTs) assessing the effects of systemic, nonopioid agents on postoperative narcotic requirements or pain scores in pediatric surgical populations...
November 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/29049078/hearts-and-minds-real-life-cardiotoxicity-with-clozapine-in-psychosis
#17
George Joy, Eromona Whiskey, Mark Bolstridge, Alejandro Porras-Segovia, Theresa A McDonagh, Carla M Plymen, Sukhi S Shergill
BACKGROUND: Schizophrenia has a 1% prevalence in the population; 30% of these patients are treatment refractory. Clozapine is the only drug licensed to treat treatment refractory psychosis, but concerns about potential adverse effects result in only a proportion of eligible patients being treated. Although a well-documented neutropenia risk is mitigated by routine blood testing, cardiac toxicity is a commonly cited reason to discontinue clozapine treatment. However, there is little data on the real-life cardiac outcomes in those receiving clozapine treatment...
October 19, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/29049014/transcriptomic-guided-drug-repositioning-supported-by-a-new-bioinformatics-search-tool-genexpharma
#18
Beste Turanli, Gizem Gulfidan, Kazim Yalcin Arga
Drug repositioning is an innovative approach to identify new therapeutic indications for existing drugs. Drug repositioning offers the promise of reducing drug development timeframes and costs, and because it involves drugs that are already in the clinic, it might remedy some of the drug safety challenges traditionally associated with drug candidates that are not yet available in the clinic. The gene-by-drug interactions are an important dimension of optimal drug repositioning and development strategies. While gene-by-drug interactions have been curated and presented in various databases, novel bioinformatics tools and approaches are timely, and required with a specific focus to support drug positioning...
October 2017: Omics: a Journal of Integrative Biology
https://www.readbyqxmd.com/read/29048983/representation-of-women-and-minorities-in-clinical-trials-for-new-molecular-entities-and-original-therapeutic-biologics-approved-by-fda-cder-from-2013-to-2015
#19
Alice Chen, Hilary Wright, Hawi Itana, Merina Elahi, Ayomide Igun, Guoxing Soon, Anne R Pariser, Emmanuel O Fadiran
BACKGROUND: The U.S. Food and Drug Administration (FDA) has made efforts to encourage adequate assessment of women, racial/ethnic minorities, and geriatric participants in clinical trials through regulations and guidance documents. This study surveyed the demographics of clinical trial participants and the presence of efficacy and safety analyses by sex for new drugs approved between 2013 and 2015 by the FDA Center for Drug Evaluation and Research. METHODS: New drug marketing applications submitted to FDA were surveyed for demographic data (sex, race, ethnicity, and age) and the presence of sex-based analyses for efficacy and safety...
October 19, 2017: Journal of Women's Health
https://www.readbyqxmd.com/read/29048935/chimeric-antigen-receptor-t-cell-therapy-for-solid-tumors-require-new-clinical-regimens
#20
Jinjing Xu, Kang Tian, Haixu Zhang, Liantao Li, Hongyan Liu, Jingjie Liu, Qing Zhang, Junnian Zheng
Chimeric antigen receptor modified T cell (CAR-T) therapy has achieved encouraging breakthroughs in the treatment of hematological malignancies. Nevertheless, this success has not yet been extrapolated to solid tumors. This review focuses on new clinical regimens that could improve the therapeutic efficacy of CAR-T in solid tumors. Areas covered: Herein, the authors reviewed recent clinical trials using CAR-T therapies for the treatment of solid tumors. Specifically, this review covered the following areas: (1) the current status of CAR-T cells in the treatment of solid tumors; (2) the major factors constraining the efficacy of CAR-T cells in solid tumors; and (3) opinions regarding the future of CAR-T as a treatment for solid tumors...
October 19, 2017: Expert Review of Anticancer Therapy
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