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Lifestyle Intervention for Overweight/Obese Pregnant Women with Polycystic Ovarian Syndrome: Lessons and Challenges.

Obes Facts 2021 Jul 26:1-10. Epub 2021 Jul 26.

Division of Endocrinology and Metabolism, Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.

Introduction And Objective: Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age, and overweight and obesity are highly prevalent in women with PCOS. This study aims to explore whether lifestyle intervention can improve gestational weight gain (GWG), glucolipid metabolism, and perinatal outcomes in overweight/obese pregnant women with PCOS.

Methods: This study is a randomized controlled trial that included overweight and obese pregnant women with PCOS who met the inclusion criteria of 8-12 gestational weeks. Read More

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Factors associated with obtaining employment among opioid use disorder patients enrolled in a therapeutic workplace intervention.

Drug Alcohol Depend 2021 Jul 21;226:108907. Epub 2021 Jul 21.

Johns Hopkins University School of Medicine, USA.

Background: Unemployment is a common problem among adults who have substance use disorder that often persists during treatment and recovery. We identified patient characteristics that were associated with obtaining employment among unemployed adults in opioid use disorder treatment.

Methods: This analysis used data from participants (N = 91) who were enrolled in a randomized controlled trial evaluating the effectiveness of a therapeutic workplace in promoting drug abstinence and employment. Read More

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Vitamin K and cardiovascular complications in CKD patients.

Kidney Int 2021 Jul 23. Epub 2021 Jul 23.

Division of Nephrology and Rheumatology, University Hospital, Rheinisch Westfälische Technische Hochschule (RWTH) Aachen, Germany. Electronic address:

Vitamin K, well known for its role in coagulation, encompasses two major subgroups: Vitamin K1 is exclusively synthesized by plants, whereas vitamin K2 mostly originates from bacterial synthesis. Vitamin K serves as a cofactor for the enzyme γ-glutamyl carboxylase, which carboxylates and thereby activates various vitamin K dependent proteins. Several vitamin K-dependent proteins are synthesized in bone but the role of vitamin K for bone health in CKD patients, in particular the prevention of osteoporosis is still not firmly established. Read More

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TVB-2640 (FASN inhibitor) for the treatment of nonalcoholic steatohepatitis: FASCINATE-1, a randomized, placebo-controlled Ph2a trial.

Gastroenterology 2021 Jul 20. Epub 2021 Jul 20.

Sagimet Biosciences Inc., San Mateo, CA USA.

Background And Aims: Increased de novo lipogenesis creates excess intrahepatic fat and lipotoxins, propagating liver damage in nonalcoholic steatohepatitis (NASH). TVB-2640, a fatty acid synthase (FASN) inhibitor, was designed to reduce excess liver fat and directly inhibit inflammatory and fibrogenic pathways. We assessed the safety and efficacy of TVB-2640 in NASH patients in the United States. Read More

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The FULL REVASC (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based Randomized Clinical Trial.

Am Heart J 2021 Jul 23. Epub 2021 Jul 23.

Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.

Background: Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI. Read More

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Insufficient evidence for Vitamin D use in COVID-19: A rapid systematic review.

Int J Clin Pract 2021 Jul 26:e14649. Epub 2021 Jul 26.

Discipline of Evidence-Based Health, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil.

Background: Vitamin D deficiency has been linked to increased severity of numerous viral infections.

Objective: To assess whether vitamin D supplementation is safe and effective for the treatment of COVID-19.

Methods: We searched MEDLINE, EMBASE, CENTRAL, LILACS, and LOVE for randomized controlled trials (RCT) published up to March 2nd evaluating the effects of vitamin D for the treatment of coronavirus disease (COVID-19). Read More

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Network meta-analysis of treatment strategies in patients with coronary artery disease and low left ventricular ejection fraction.

J Card Surg 2021 Jul 26. Epub 2021 Jul 26.

Department of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York City, New York, USA.

Objective: The optimal treatment strategy in patients with coronary artery disease (CAD) and low left ventricular ejection fraction (LVEF) remains controversial. Herein, we conducted a network meta-analysis comparing coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), and optimal medical therapy (OMT) in patients with CAD and low LVEF.

Methods: MEDLINE and EMBASE were searched through March, 2021 to identify randomized controlled trials (RCTs) and propensity-score matched (PSM) studies comparing CABG, PCI, and OMT. Read More

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The Medial Border of Laparoscopic D3 Lymphadenectomy for Right Colon Cancer: Results from an Exploratory Pilot Study.

Dis Colon Rectum 2021 Jul 21. Epub 2021 Jul 21.

Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Department of Gastrointestinal (Tumor) Surgery, Guangdong Province Hospital of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China Department of oncological surgery, the Second Affiliated Hospital of Fujian Medical University, Quanzhou, China Department of Colorectal, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China Gastric and Intestinal Department of the First Hospital of Jilin University, Changchun, China.

Background: Opinions vary on the medial border of D3 lymphadenectomy for right colon cancer. Most surgeons placed the medial border along the left side of superior mesenteric vein, but some considered the left side of superior mesenteric artery as the medial border.

Objectives: This study investigated the clinical outcomes of laparoscopic D3 lymphadenectomy for right colon cancer with the medial border along the left side of superior mesenteric artery. Read More

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Tolcapone in obsessive-compulsive disorder: a randomized double-blind placebo-controlled crossover trial.

Int Clin Psychopharmacol 2021 Jul 20. Epub 2021 Jul 20.

University of Chicago, Department of Psychiatry and Behavioral Neuroscience, Chicago, Illinois, USA Department of Psychiatry, University of Cambridge, Cambridge, UK Department of Psychiatry, Faculty of Medicine, University of Southampton; and Southern Health NHS Foundation Trust, Southampton, UK.

Objective: Despite the availability of evidence-based treatments for obsessive-compulsive disorder (OCD), not all patients experience sufficient benefit or are able to tolerate them. Tolcapone is a catechol-O-methyl-transferase (COMT) enzyme inhibitor that augments cortical dopaminergic transmission. Conduct a proof of concept study to examine whether a COMT inhibitor would reduce OCD symptoms to a greater extent than placebo. Read More

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Immunogenicity and safety of a recombinant fusion protein vaccine (V-01) against coronavirus disease 2019 in healthy adults: a randomized, double-blind, placebo-controlled, phase II trial.

Chin Med J (Engl) 2021 Jul 22. Epub 2021 Jul 22.

Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, Guangdong 510440, China Guangdong Provincial Center for Disease Control and Prevention, Guangzhou, Guangdong 511430, China Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, Hubei 430071, China National Institutes for Food and Drug Control, Beijing 100050, China Gaozhou Center for Disease Control and Prevention, Maoming, Guangdong 525000, China Livzon Bio Inc., Zhuhai, Guangdong 519045, China Key Laboratory of Infection and Immunity, Institute of Biophysics, Chinese Academy of Sciences, Beijing 100101, China Institute for Hepatology, National Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China.

Background: Innovative coronavirus disease 2019 (COVID-19) vaccines, with elevated global manufacturing capacity, enhanced safety and efficacy, simplified dosing regimens, and distribution that is less cold chain-dependent, are still global imperatives for tackling the ongoing pandemic. A previous phase I trial indicated that the recombinant COVID-19 vaccine (V-01), which contains a fusion protein (IFN-PADRE-RBD-Fc dimer) as its antigen, is safe and well tolerated, capable of inducing rapid and robust immune responses, and warranted further testing in additional clinical trials. Herein, we aimed to assess the immunogenicity and safety of V-01, providing rationales of appropriate dose regimen for further efficacy study. Read More

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Swabs Containing Tea Tree Oil and Chamomile Oil Versus Baby Shampoo in Patients With Seborrheic Blepharitis: A Double-Blind Randomized Clinical Trial.

Eye Contact Lens 2021 Jul 21. Epub 2021 Jul 21.

Department of Ophthalmology (B.M.), University of Health Sciences, Basaksehir Cam ve Sakura City Hospital, Istanbul, Turkey; Department of Ophthalmology (C.A.), Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey; Department of Ophthalmology (A.Y.-T., A.S.), Koc University Medical Faculty, Istanbul, Turkey; Department of Medical Microbiology (H.B.-T., E.T., Y.O.-B.), Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey; and Department of Dermatology (Z.K.), Cerrahpasa Medical Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey.

Purpose: The comparison of the efficacy of swabs containing tea tree oil and chamomile oil and baby shampoo (BS) in the treatment of seborrheic blepharitis was aimed.

Methods: This randomized, double-blind, parallel-group, active control, multicenter clinical trial included patients with seborrheic blepharitis using block randomization (BS, n=23; swabs, n=26). Patients were treated with BS or swabs for 8 weeks followed by 4 weeks of treatment withdrawal. Read More

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Mediterranean and Western diet effects on Alzheimer's disease biomarkers, cerebral perfusion, and cognition in mid-life: A randomized trial.

Alzheimers Dement 2021 Jul 26. Epub 2021 Jul 26.

Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

Introduction: Mid-life dietary patterns are associated with Alzheimer's disease (AD) risk, although few controlled trials have been conducted.

Methods: Eighty-seven participants (age range: 45 to 65) with normal cognition (NC, n = 56) or mild cognitive impairment (MCI, n = 31) received isocaloric diets high or low in saturated fat, glycemic index, and sodium (Western-like/West-diet vs. Mediterranean-like/Med-diet) for 4 weeks. Read More

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Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial.

JAMA Netw Open 2021 Jul 1;4(7):e2117763. Epub 2021 Jul 1.

Denver Public Health, Denver, Colorado.

Importance: The National HIV Strategic Plan for the US recommends HIV screening in emergency departments (EDs). The most effective approach to ED-based HIV screening remains unknown.

Objective: To compare strategies for HIV screening when integrated into usual ED practice. Read More

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Use of Telemedicine in Depression Care by Physicians: Scoping Review.

JMIR Form Res 2021 Jul 26;5(7):e29159. Epub 2021 Jul 26.

Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.

Background: Depression is a common disorder, and it creates burdens on people's mental and physical health as well as societal costs. Although traditional in-person consultations are the usual mode of caring for patients with depression, telemedicine may be well suited to psychiatric assessment and management. Telepsychiatry can be defined as the use of information and communication technologies such as videoconferencing and telephone calls for the care of psychopathologies. Read More

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Repositioning Chairs in the Diagnosis and Treatment of Benign Paroxysmal Positional Vertigo - A Systematic Review.

J Int Adv Otol 2021 Jul;17(4):353-360

Copenhagen Hearing and Balance Center, Department of Otorhinolaryngology Head and Neck Surgery and Audiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.

Multi-axial repositioning chairs such as the TRV chair and the Epley Omniax Rotator (EO) are newer alternatives in the treatment of complex and recurrent cases of the common peripheral vertigo disorder, benign paroxysmal positional vertigo (BPPV). The objective of this systematic review is to collect and synthesize current knowledge on the clinical characteristics of repositioning chairs for treatment of BPPV. A systematic search of the PubMed and EmBase databases was conducted and data regarding clinical characteristics were extracted from both retrospective and prospective studies, and a qualitative synthesis was made. Read More

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Dose Response in the Subthreshold Nanosecond Laser Trial in Early Stages of AMD: A LEAD Study Report.

Ophthalmic Surg Lasers Imaging Retina 2021 Jul 1;52(7):380-386. Epub 2021 Jul 1.

Background And Objective: To examine the association between treatment parameters and the progression to late age-related macular degeneration (AMD) in the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study, a randomized, controlled trial of a subthreshold nanosecond laser (SNL) for slowing disease progression in the early stages of AMD.

Patients And Methods: The association between treatment parameters early in the trial period for participants in the SNL arm of the LEAD study and time to develop late AMD during the 3-year trial duration was examined. Parameters included treatment energy at the baseline and 6-month visits and the number of laser spots visible on fundus autofluorescence (FAF) imaging taken at 6 and 12 months (taken as a proxy measure of early, adequate delivery of the laser treatment at the baseline and 6-month visits, respectively). Read More

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Effects of participation in a U.S. trial of newborn genomic sequencing on parents at risk for depression.

J Genet Couns 2021 Jul 26. Epub 2021 Jul 26.

Division of Genetics and Genomics, Boston Children's Hospital, Boston, Massachusetts, USA.

Much emphasis has been placed on participant's psychological safety within genomic research studies; however, few studies have addressed parental psychological health effects associated with their child's participation in genomic studies, particularly when parents meet the threshold for clinical concern for depression. We aimed to determine if parents' depressive symptoms were associated with their child's participation in a randomized-controlled trial of newborn exome sequencing. Parents completed the Edinburgh Postnatal Depression Scale (EPDS) at baseline, immediately post-disclosure, and 3 months post-disclosure. Read More

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Postoperative Adjuvant therapy versus Surgery Alone for Stage IIB-III Esophageal Squamous Cell Carcinoma: A Phase III Randomized Controlled Trial.

Oncologist 2021 Jul 26. Epub 2021 Jul 26.

Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Background: Retrospective studies have shown that adjuvant treatment improves survival of patients with stage IIB-III esophageal squamous cell carcinoma, but there is no evidence from prospective trials so far.

Methods: Patients with pathological stage IIB-III esophageal squamous cell carcinoma were randomly assigned to receive surgery alone (SA), postoperative radiotherapy (PORT), or postoperative concurrent chemoradiotherapy (POCRT). PORT patients received 54 Gy in 27 fractions; POCRT group received 50. Read More

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Evaluating Concordance of Bodies of Evidence From Randomized Controlled Trials, Dietary Intake and Biomarkers of Intake in Cohort Studies: A Meta-Epidemiological Study.

Adv Nutr 2021 Jul 26. Epub 2021 Jul 26.

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

We aimed to identify and compare empirical data to determine the concordance of diet-disease effect estimates of bodies of evidence (BoE) from randomized controlled trials (RCTs), dietary intake and biomarkers of dietary intake in cohort studies (CSs). The Cochrane Database of Systematic Reviews and MEDLINE were searched for systematic reviews (SRs) of RCTs, and SRs of CSs that investigated both dietary intake and biomarkers of intake published between 01.01. Read More

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Comparing an e-Health program vs home rehabilitation program in patients with non-specific low back pain: A study protocol randomized feasibility trial.

J Back Musculoskelet Rehabil 2021 Jul 13. Epub 2021 Jul 13.

Department of Nursing, Physical Therapy and Medicine, University of Almeria, Spain.

Background: There is little evidence on the reliability of the web application-based rehabilitation systems to treat chronic low back pain (CLBP).

Methods: This protocol describes a double-blind, randomized controlled feasibility trial of an e-Health intervention developed to support the self-management of people with CLBP in primary care physiotherapy. Three Hospitals with primary care for outpatients will be the units of randomisation, in each Hospital the participants will be randomized to one of two groups, a pragmatic control group receiving either the usual home program based on electrostimulation and McKenzie Therapy and e-Health intervention. Read More

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[Parathyroid hormone-related protein aggravates nonalcoholic fatty liver disease induced by methionine choline-deficient diet in mice].

Authors:
B Qin N Diao L Bai

Nan Fang Yi Ke Da Xue Xue Bao 2021 Jul;41(7):1037-1043

Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.

Objective: To study the effect of parathyroid hormone-related protein (PTHrP) on nonalcoholic fatty liver disease (NAFLD) induced by methionine choline-deficient diet (MCD) in mice.

Methods: Twelve male C57BL/6J mice were randomized into blank control group, vehicle group and PTHrP group (=4). The mice in vehicle group and PTHrP group received injections of a control adeno-associated virus (AAV) vector and an AVV vector carrying PTHrP (AAV-PTHrP) gene, respectively, followed one week later by MCD feeding for 3 weeks; the mice in the blank control were fed a normal diet for 4 weeks. Read More

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THRIVE intervention development: using participatory action research principles to guide a mHealth app-based intervention to improve oncology care.

J Hosp Manag Health Policy 2021 Mar 25;5. Epub 2021 Mar 25.

Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA, USA.

Background: Women with hormone receptor-positive, early-stage breast cancer who adhere to adjuvant endocrine therapy (AET) reduce the risk of cancer recurrence and mortality. AET, however, is associated with adverse symptoms that often result in poor adherence. We applied participatory action research (PAR) principles to conduct focus groups and interviews to refine and enhance a web-enabled app intervention that facilitates patient-provider communication about AET-related symptoms and other barriers to adherence. Read More

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A Phase 3 Study of Enarodustat in Anemic Patients with CKD not Requiring Dialysis: The SYMPHONY ND Study.

Kidney Int Rep 2021 Jul 12;6(7):1840-1849. Epub 2021 May 12.

Fukuoka Renal Clinic, Fukuoka, Japan.

Introduction: Enarodustat (JTZ-951) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that might be a new therapeutic approach for managing anemia in patients with chronic kidney disease (CKD). We evaluated the efficacy (noninferiority to darbepoetin alfa [DA]) and safety of enarodustat in Japanese anemic patients with CKD not requiring dialysis.

Methods: Erythropoiesis-stimulating agent (ESA)-naïve patients and ESA-treated patients were randomized at a 1:1 ratio to receive enarodustat orally once daily or DA subcutaneously every 2 or 4 weeks for 24 weeks, respectively. Read More

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A Randomized Trial of Roxadustat in Anemia of Kidney Failure: SIERRAS Study.

Kidney Int Rep 2021 Jul 17;6(7):1829-1839. Epub 2021 Apr 17.

FibroGen, Inc., San Francisco, California, USA.

Introduction: Erythropoiesis-stimulating agents, standard of care for anemia of end-stage kidney disease, are associated with cardiovascular events. We evaluated the efficacy and safety of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis.

Methods: SIERRAS was a phase 3, randomized, open-label, active-controlled study enrolled adults on dialysis for end-stage kidney disease receiving erythropoiesis-stimulating agents for anemia. Read More

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Phase 3 Study of Roxadustat to Treat Anemia in Non-Dialysis-Dependant CKD.

Kidney Int Rep 2021 Jul 17;6(7):1810-1828. Epub 2021 Apr 17.

Astellas Pharma Europe B.V., Leiden, The Netherlands.

Introduction: Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that has demonstrated safety and efficacy versus placebo in phase III trials in patients with anemia of chronic kidney disease (CKD) who were not on dialysis (NDD).

Methods: This was a phase III, active-controlled, multicenter, partially randomized, open-label study in Japanese patients with NDD CKD. Patients who had used recombinant human erythropoietin or darbepoetin alfa (DA) before conversion were randomized to roxadustat or DA (comparative arms). Read More

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A family nurse-led intervention for reducing health services' utilization in individuals with chronic diseases: The ADVICE pilot study.

Int J Nurs Sci 2021 Jul 12;8(3):264-270. Epub 2021 May 12.

ASL Rome 4, Rome, Italy.

Objectives: Intensive health services' utilization is common in older individuals affected by chronic diseases. This study assessed whether a structured family nurse-led educational intervention would be effective in reducing health services' use (readmissions and/or emergency service access) among older people affected by chronic conditions.

Methods: This is a non-randomized before-after pilot study. Read More

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Controversies' clarification regarding ribavirin efficacy in measles and coronaviruses: Comprehensive therapeutic approach strictly tailored to COVID-19 disease stages.

Authors:
George D Liatsos

World J Clin Cases 2021 Jul;9(19):5135-5178

Department of Internal Medicine, "Hippokration" General Hospital, Athens 11527, Attiki, Greece.

Background: Ribavirin is a broad-spectrum nucleoside antiviral drug with multimodal mechanisms of action, which supports its longevity and quality as a clinical resource. It has been widely administered for measles and coronavirus infections. Despite the large amount of data concerning the use of ribavirin alone or in combination for measles, severe acute respiratory syndrome, Middle East respiratory syndrome, and coronavirus disease 2019 (COVID-19) outbreaks, the conclusions of these studies have been contradictory. Read More

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Cross-Sectional Survey of Clinical Trials of Stem Cell Therapy for Heart Disease Registered at ClinicalTrials.gov.

Front Cardiovasc Med 2021 8;8:630231. Epub 2021 Jul 8.

Department of International Medical Center/Ward of General Practice, West China Hospital, Sichuan University, Chengdu, China.

It is important to register clinical trials before their implementation. There is a lack of study to evaluate registered clinical trials of stem cell therapy for heart diseases. Our study used the registration information at ClinicalTrials. Read More

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Radiation Therapy After Radical Prostatectomy: What Has Changed Over Time?

Front Surg 2021 9;8:691473. Epub 2021 Jul 9.

Division of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.

The role and timing of radiotherapy (RT) in prostate cancer (PCa) patients treated with radical prostatectomy (RP) remains controversial. While recent trials support the oncological safety of early salvage RT (SRT) compared to adjuvant RT (ART) in selected patients, previous randomized studies demonstrated that ART might improve recurrence-free survival in patients at high risk for local recurrence based on adverse pathology. Although ART might improve survival, this approach is characterized by a risk of overtreatment in up to 40% of cases. Read More

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Efficacy of Integrated Traditional Chinese and Western Medicine for Treating COVID-19: A Systematic Review and Meta-Analysis of RCTs.

Front Public Health 2021 8;9:622707. Epub 2021 Jul 8.

School of Second Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.

Integrated Chinese and Western medicine (integrated medicine) is routinely used in the treatment of coronavirus disease 2019 (COVID-19) in China. In this study, we undertook a systematic review and meta-analysis of published randomized controlled trials (RCTs) to evaluate the efficacy of integrated medicine therapy for patients with COVID-19. In this meta-analysis, we searched PubMed, Embase, Web of Science, SinoMed, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), and Wanfang databases from inception to April 12, 2021, to identify RCTs of integrated medicine in the treatment of COVID-19. Read More

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