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Efficacy and safety of Zolpidem in the treatment of insomnia disorder for one month: a meta-analysis of a randomized controlled trial.

Sleep Med 2021 Sep 20;87:250-256. Epub 2021 Sep 20.

Department of Psychiatry, Sleep Medicine Centre, First Affiliated Hospital of Jinan University, Guangzhou, Guangdong Province, 510632, PR China. Electronic address:

Subject: A meta-analysis of a randomized placebo-controlled trial was used to evaluate the effectiveness and safety of Zolpidem in the treatment of insomnia disorder for one month.

Method: Searched from PubMed, EMBASE, MEDLINE, PsycINFO, Cochrane Central Register of Controlled Trials and web of science from inception to May 13, 2021. In addition, we also searched ClinicalTrials. Read More

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September 2021

The mode of speciation during a recent radiation in open-ocean phytoplankton.

Curr Biol 2021 Oct 15. Epub 2021 Oct 15.

Department of Earth Sciences, University of Oxford, South Parks Road, Oxford OX1 3AN, UK.

Despite the enormous ecological importance of marine phytoplankton, surprisingly little is known about how new phytoplankton species originate and evolve in the open ocean, in the absence of apparent geographic barriers that typically act as isolation mechanisms in speciation. To investigate the mechanism of open-ocean speciation, we combined fossil and climatic records from the late Quaternary with genome-wide evolutionary genetic analyses of speciation in the ubiquitous and abundant pelagic coccolithophore genus Gephyrocapsa (including G. huxleyi, formerly known as Emiliania huxleyi). Read More

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October 2021

A correlative light electron microscopy approach reveals plasmodesmata ultrastructure at the graft interface.

Plant Physiol 2021 Oct 23. Epub 2021 Oct 23.

Univ. Bordeaux, CNRS, INSERM, Bordeaux Imaging Center, BIC, UMS 3420, US 4, F-33000 Bordeaux, France.

Despite recent progress in our understanding of graft union formation, we still know little about the cellular events underlying the grafting process. This is partially due to the difficulty of reliably targeting the graft interface in electron microscopy to study its ultrastructure and three-dimensional architecture. To overcome this technological bottleneck, we developed a correlative light electron microscopy (CLEM) approach to study the graft interface with high ultrastructural resolution. Read More

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October 2021

Management and outcomes of patients with left atrial appendage thrombus prior to percutaneous closure.

Heart 2021 Oct 22. Epub 2021 Oct 22.

Severance Cardiovascular Hospital, Yonsei, Korea (the Republic of).

Objective: Left atrial appendage (LAA) thrombus has heretofore been considered a contraindication to percutaneous LAA closure (LAAC). Data regarding its management are very limited. The aim of this study was to analyse the medical and invasive treatment of patients referred for LAAC in the presence of LAA thrombus. Read More

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October 2021

Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial.

BMJ Open 2021 Oct 22;11(10):e051392. Epub 2021 Oct 22.

Department of Physio- and Occupational Therapy, Lillebaelt Hospital - University Hospital of Southern Denmark, Vejle, Denmark.

Introduction: Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain, and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appears to improve multiple outcomes moderately in patients with hip OA. Read More

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October 2021

Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study.

Clin Lymphoma Myeloma Leuk 2021 Aug 28. Epub 2021 Aug 28.

Institute of Experimental Cancer Research, Comprehensive Cancer Center Ulm, University Hospital of Ulm, 89081 Ulm, Germany. Electronic address:

Introduction: This double-blind, parallel-group, active-controlled phase III trial (NCT02260804) assessed CT-P10 and rituximab safety and efficacy in patients with previously untreated low-tumor-burden follicular lymphoma (LTBFL), including after a single switch from rituximab to CT-P10.

Patients And Methods: LTBFL patients were randomized (1:1) to receive CT-P10 or rituximab (375 mg/m intravenously; day 1 of 4 7-day cycles). Patients achieving disease control entered a 2-year maintenance period. Read More

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A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer.

Gynecol Oncol 2021 Oct 19. Epub 2021 Oct 19.

Gynecologic Oncology Program, AdventHealth Cancer Institute, Orlando, FL 32804, USA. Electronic address:

Objective: Our objective was to assess safety and adverse events associated with intraperitoneal Olvi-Vec virotherapy in patients with platinum-resistant or refractory ovarian cancer (PRROC). Secondary objectives included objective response rate (ORR) per RECIST 1.1 and progression-free survival (PFS). Read More

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October 2021

Feasibility and Efficiency of the BEFORE (Better Exercise and Food, Better Recovery) Prehabilitation Program.

Nutrients 2021 Oct 2;13(10). Epub 2021 Oct 2.

Department of Surgery, Zuyderland Medical Center, Dr. H van der Hoffplein 1, 6162BG Sittard-Geleen, The Netherlands.

Prehabilitation has been postulated as an effective preventive intervention to reduce postoperative complications, particularly for elderly patients with a relatively high risk of complications. To date, it remains to be determined whether prehabilitation increases physical capacity and reduces postoperative complications. The aim of this study was to assess the feasibility of a 4-week multimodal prehabilitation program consisting of a personalized, supervised training program and nutritional intervention with daily fresh protein-rich food for colorectal cancer patients aged over 64 years prior to surgery. Read More

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October 2021

Serum Levels of Dihomo-Gamma (γ)-Linolenic Acid (DGLA) Are Inversely Associated with Linoleic Acid and Total Death in Elderly Patients with a Recent Myocardial Infarction.

Nutrients 2021 Sep 30;13(10). Epub 2021 Sep 30.

Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, 0315 Oslo, Norway.

Dihomo-gamma-linolenic acid (DGLA) is an -6 polyunsaturated fatty acid (PUFA) derived from linoleic acid (LA). The LA:DGLA ratio reflects conversion from LA to DGLA. Low levels of DGLA in serum have been related to poor outcome in myocardial infarction (MI) patients. Read More

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September 2021

Association of Body Weight Variability with Adverse Cardiovascular Outcomes in Patients with Pre-Dialysis Chronic Kidney Disease.

Nutrients 2021 Sep 26;13(10). Epub 2021 Sep 26.

Department of Internal Medicine, Chonnam National University Medical School and Chonnam National University Hospital, Gwangju 61469, Korea.

To investigate the association of body weight variability (BWV) with adverse cardiovascular (CV) outcomes in patient with pre-dialysis chronic kidney disease (CKD), a total of 1867 participants with pre-dialysis CKD from Korean Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) were analyzed. BWV was defined as the average absolute difference between successive values. The primary outcome was a composite of non-fatal CV events and all-cause mortality. Read More

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September 2021

Colchicine to Prevent Sympathetic Denervation after an Acute Myocardial Infarction: The COLD-MI Trial Protocol.

Medicina (Kaunas) 2021 Sep 30;57(10). Epub 2021 Sep 30.

Department of Cardiology, Montpellier University Hospital, 34295 Montpellier, France.

Inflammatory processes are deeply involved in ischemia-reperfusion injuries (IRI) and ventricular remodelling (VR) after a ST-segment elevation myocardial infarction (STEMI). They are associated with clinical adverse events (heart failure and cardiovascular death) adding damage to the myocardium after reperfusion. Moreover, acute myocardial infarction (AMI) induces a local sympathetic denervation leading to electrical instability and arrythmia. Read More

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September 2021

Effectiveness, Cost-Utility, and Safety of Neurofeedback Self-Regulating Training in Patients with Post-Traumatic Stress Disorder: A Randomized Controlled Trial.

Healthcare (Basel) 2021 Oct 11;9(10). Epub 2021 Oct 11.

Jangheung Integrative Medical Hospital, Wonkwang University, 121, Rohaseu-ro, Anyang-myeon, Jangheung-gun 59338, Jeollanam-do, Korea.

Post-traumatic stress disorder (PTSD) is characterized by neurophysiological and psycho-emotional problems after exposure to trauma. Several pharmacological and psychotherapy limitations, such as adverse events and low adherence, increase the need for alternative therapeutic options. Neurofeedback is widely used for PTSD management. Read More

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October 2021

Spinal Cord Signal Change on Magnetic Resonance Imaging May Predict Worse Clinical In- and Outpatient Outcomes in Patients with Spinal Cord Injury: A Prospective Multicenter Study in 459 Patients.

J Clin Med 2021 Oct 18;10(20). Epub 2021 Oct 18.

Division of Neurosurgery, Department of Surgery, University of Toronto, Toronto, ON M5T 2S8, Canada.

Prognostic factors for clinical outcome after spinal cord (SC) injury (SCI) are limited but important in patient management and education. There is a lack of evidence regarding magnetic resonance imaging (MRI) and clinical outcomes in SCI patients. Therefore, we aimed to investigate whether baseline MRI features predicted the clinical course of the disease. Read More

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October 2021

Real-World Incidence of Immune-Related Adverse Events Associated with Nivolumab Plus Ipilimumab in Patients with Advanced Renal Cell Carcinoma: A Retrospective Observational Study.

J Clin Med 2021 Oct 18;10(20). Epub 2021 Oct 18.

Department of Urology, Saitama Medical Center Saitama Medical University, Kawagoe 350-8550, Japan.

Real-world incidence of immune-related adverse events (irAEs) associated with nivolumab plus ipilimumab in patients with renal cell carcinoma (RCC) has been rarely demonstrated. The present study aims to report the safety outcomes of this combination therapy in the real-life population. We conducted a multi-institutional retrospective observational study that assessed the incidence and severity of irAEs associated with nivolumab plus ipilimumab in 41 Japanese patients with metastatic and/or locally advanced RCC. Read More

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October 2021

Coronary Artery Disease in Patients Older than 35 and Eligible for Cardiovascular Secondary Prevention: An Italian Retrospective Observational Analysis of Healthcare Administrative Databases.

J Clin Med 2021 Oct 14;10(20). Epub 2021 Oct 14.

Fondazione Ricerca e Salute (ReS)-Research and Health Foundation, Casalecchio di Reno, 40033 Bologna, Italy.

Background: This study describes patients with coronary artery disease (CAD) who are eligible for secondary prevention and assesses their healthcare consumption and costs from the perspective of the Italian National Health Service (INHS).

Methods: From the Fondazione Ricerca e Salute's database, which collects Italian healthcare administrative data, all patients aged ≥ 35, with ≥1 primary in-hospital CAD diagnosis and/or procedure on the coronary arteries, or with the specific disease exemption code, and who are suitable for long-term secondary prevention treatments, were identified in 2018 and analyzed. Demographics, comorbidities, one-year supplied drugs, hospitalizations, and costs were analyzed. Read More

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October 2021

Outcomes of Different Reperfusion Strategies of Multivessel Disease Undergoing Newer-Generation Drug-Eluting Stent Implantation in Patients with Non-ST-Elevation Myocardial Infarction and Chronic Kidney Disease.

J Clin Med 2021 Oct 9;10(20). Epub 2021 Oct 9.

Department of Cardiology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam 13496, Korea.

Because available data are limited, we compared the 2-year clinical outcomes among different reperfusion strategies (culprit-only percutaneous coronary intervention (C-PCI), multivessel PCI (M-PCI), complete revascularization (CR) and incomplete revascularization (IR)) of multivessel disease (MVD) undergoing newer-generation drug-eluting stent implantation in patients with non-ST-elevation myocardial infarction (NSTEMI) and chronic kidney disease (CKD). In this nonrandomized, multicenter, retrospective cohort study, a total of 1042 patients (C-PCI, = 470; M-PCI, = 572; CR, = 432; IR, = 140) were recruited from the Korea Acute Myocardial Infarction Registry (KAMIR) and evaluated. The primary outcome was the occurrence of major adverse cardiac events, defined as all-cause death, recurrent myocardial infarction and any repeat coronary revascularization. Read More

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October 2021

Clinical Significance of Carotid Intima-Media Complex and Carotid Plaque Assessment by Ultrasound for the Prediction of Adverse Cardiovascular Events in Primary and Secondary Care Patients.

J Clin Med 2021 Oct 9;10(20). Epub 2021 Oct 9.

Department of Cardiac and Vascular Diseases, Institute of Cardiology, Jagiellonian University Medical College, John Paul II Hospital, 31-202 Krakow, Poland.

Recently published recommendations from the American Society of Echocardiography on 'Carotid Arterial Plaque Assessment by Ultrasound for the Characterization of Atherosclerosis and Evaluation of Cardiovascular Risk' provoked discussion once more on the potential clinical applications of carotid intima-media complex thickness (CIMT) and carotid plaque assessment in the context of cardiovascular risk in both primary and secondary care patients. This review paper addresses key issues and milestones regarding indications, assessment, technical aspects, recommendations, and interpretations of CIMT and carotid plaque findings. We discuss lacks of evidence, limitations, and possible future directions. Read More

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October 2021

Pharmacology and Adverse Events of Emergency-Use Authorized Medication in Moderate to Severe COVID-19.

Pharmaceuticals (Basel) 2021 Sep 23;14(10). Epub 2021 Sep 23.

Department of Internal Medicine, Division of Allergy, Immunology and Rheumatology, Taichung Veterans General Hospital, Taichung 407219, Taiwan.

Some effective drugs have been approved or issued an Emergency Use Authorization for the treatment of COVID-19 in hospitalized patients, but post-market surveillance is warranted to monitor adverse events. We reviewed clinical trials and case reports in patients with moderate-to-severe COVID-19 infection who received remdesivir, baricitinib, tocilizumab, or sarilumab. The drug-specific pharmacokinetics, toxicity, and drug interactions are summarized in this study. Read More

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September 2021

Population Ecology and Genetic Diversity of the Invasive Alien Species in Lake Trasimeno (Italy).

Biology (Basel) 2021 Oct 18;10(10). Epub 2021 Oct 18.

Department of Chemistry, Biology and Biotechnology, University of Perugia, Via Elce di Sotto 8, 06123 Perugia, Italy.

The deliberate or accidental introduction of invasive alien species (IAS) causes negative ecological and economic impacts altering ecosystem processes, imperiling native species and causing damage to human endeavors. A monthly monitoring program was performed in Lake Trasimeno (Central Italy) from July 2018 to July 2019 in order to provide an upgrade of the population ecology of and to assess the genetic diversity by analyzing the relationships among mitochondrial DNA diversity. Our results confirmed that is well acclimatized in the lake, revealing a stable population structure favored by the resources and conditions typical of this ecosystem, which seem to be optimal for the maintenance of the species. Read More

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October 2021

The Evolution of Clinically Aggressive Triple-Negative Breast Cancer Shows a Large Mutational Diversity and Early Metastasis to Lymph Nodes.

Cancers (Basel) 2021 Oct 12;13(20). Epub 2021 Oct 12.

Laboratorio Nacional en Salud, Diagnóstico Molecular y Efecto Ambiental en Enfermedades Crónico-Degenerativas, Facultad de Estudios Superiores Iztacala, Tlalnepantla 54090, Mexico.

In triple-negative breast cancer (TNBC), only 30% of patients treated with neoadjuvant chemotherapy achieve a pathological complete response after treatment and more than 90% die due to metastasis formation. The diverse clinical responses and metastatic developments are attributed to extensive intrapatient genetic heterogeneity and tumor evolution acting on this neoplasm. In this work, we aimed to evaluate genomic alterations and tumor evolution in TNBC patients with aggressive disease. Read More

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October 2021

Long-term efficacy of T3 analogue Triac in children and adults with MCT8 deficiency: a real-life retrospective cohort study.

J Clin Endocrinol Metab 2021 Oct 22. Epub 2021 Oct 22.

Department of Pediatrics, Hematology and Oncology, Medical University of Gdańsk, Gdańsk, Poland.

Context: Patients with mutations in thyroid hormone transporter MCT8 have developmental delay and chronic thyrotoxicosis associated with being underweight and having cardiovascular dysfunction. Our previous trial showed improvement of key clinical and biochemical features during one year of treatment with the T3-analogue Triac. Long-term follow-up data are lacking. Read More

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October 2021

Effectiveness of knowledge brokering and recommendation dissemination for influencing healthcare resource allocation decisions: A cluster randomised controlled implementation trial.

PLoS Med 2021 Oct 22;18(10):e1003833. Epub 2021 Oct 22.

School of Primary and Allied Health Care, Monash University, Victoria, Australia.

Background: Implementing evidence into clinical practice is a key focus of healthcare improvements to reduce unwarranted variation. Dissemination of evidence-based recommendations and knowledge brokering have emerged as potential strategies to achieve evidence implementation by influencing resource allocation decisions. The aim of this study was to determine the effectiveness of these 2 research implementation strategies to facilitate evidence-informed healthcare management decisions for the provision of inpatient weekend allied health services. Read More

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October 2021

Combined effects of acupuncture and auricular acupressure for relieving cancer-related fatigue in patients during lung cancer chemotherapy: A protocol for systematic review and meta-analysis.

Authors:
Han Li Huan Liu

Medicine (Baltimore) 2021 Oct;100(42):e27502

Gynecology of Integrated Traditional Chinese and Western Medicine, Beijing Xicheng Guangwai Hospital, Beijing, China.

Background: Increasing attention has been paid to acupuncture and auricular acupressure as alternative strategies for cancer related fatigue (CRF) management. Therefore, we design this systematic review and meta-analysis to explore the efficacy and safety of acupuncture and auricular acupressure for relieving CRF in patients during lung cancer chemotherapy.

Methods: From the inception to August 2021, the Web of Science, EMBASE, PubMed, and Cochrane Library electronic databases were searched using the key phrases "acupuncture", "auricular acupressure", and "lung cancer" for all relevant trials. Read More

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October 2021

Design of a phase III efficacy, immunogenicity, and safety study of 9-valent human papillomavirus vaccine in prevention of oral persistent infection in men.

Contemp Clin Trials 2021 Oct 19:106592. Epub 2021 Oct 19.

Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA. Electronic address:

Background: Seven high-risk human papillomavirus (HPV) types (16/18/31/33/45/52/58) covered by the 9-valent HPV (9vHPV) vaccine cause >90% of HPV-related head and neck cancers (HNCs). An ongoing clinical trial (NCT04199689) was designed to evaluate 9vHPV vaccine efficacy against HPV oral persistent infection, a surrogate endpoint for HPV-related HNCs.

Methods: In this double-blind, placebo-controlled, international trial, men aged 20-45 years (N = 6000) are randomized 1:1 to receive 9vHPV vaccine or placebo on day 1, month 2, and month 6. Read More

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October 2021

Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment.

JAMA Netw Open 2021 Oct 1;4(10):e2130587. Epub 2021 Oct 1.

Department of Urology, Mayo Clinic, Jacksonville, Florida.

Importance: With a growing interest in the use of real-world evidence for regulatory decision-making, it is important to understand whether real-world data can be used to emulate the results of randomized clinical trials.

Objective: To use electronic health record and administrative claims data to emulate the ongoing PRONOUNCE trial (A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease).

Design, Setting, And Participants: This retrospective, propensity-matched cohort study included adult men with a diagnosis of prostate cancer and cardiovascular disease who initiated either degarelix or leuprolide between December 24, 2008, and June 30, 2019. Read More

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October 2021

Physiological and Pathological Roles of Aldose Reductase.

Metabolites 2021 Sep 27;11(10). Epub 2021 Sep 27.

Christina Lee Brown Envirome Institute, School of Medicine, University of Louisville, Louisville, KY 40202, USA.

Aldose reductase (AR) is an aldo-keto reductase that catalyzes the first step in the polyol pathway which converts glucose to sorbitol. Under normal glucose homeostasis the pathway represents a minor route of glucose metabolism that operates in parallel with glycolysis. However, during hyperglycemia the flux of glucose via the polyol pathway increases significantly, leading to excessive formation of sorbitol. Read More

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September 2021

Total Colectomy as a Part of Ultra-Radical Surgery for Ovarian Cancer-Short- and Long-Term Outcomes.

Curr Oncol 2021 Oct 18;28(5):4223-4233. Epub 2021 Oct 18.

2nd Department of Obstetrics and Gynecology, Centre of Postgraduate Medical Education, 01-809 Warsaw, Poland.

(1) Background: The aim of this study was to assess the outcomes for patients who underwent total colectomy (TC) as a part of surgery for ovarian cancer (OC). (2) Methods: We performed a retrospective analysis of 1636 OC patients. Residual disease (RD) was reported using Sugarbaker's completeness of cytoreduction score. Read More

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October 2021

Clinical Outcomes from Dose-Reduced Radiotherapy to the Prostate in Elderly Patients with Localized Prostate Cancer.

Curr Oncol 2021 Sep 26;28(5):3729-3737. Epub 2021 Sep 26.

Department of Oncology, University of Calgary, Calgary, AB T2N 4N2, Canada.

Radical treatment of localized prostate cancer in elderly patients may lead to unacceptable treatment-associated toxicities that adversely impact quality of life without improving survival outcomes. This study reports on a cohort of 54 elderly (>70 years) patients that received 4000-5000 cGy of palliative external beam radiotherapy (EBRT) as an alternative to androgen deprivation therapy (ADT). The primary outcome of interest was the period of ADT-free survival, and secondary outcomes included overall survival (OS) and metastases-free survival (MFS). Read More

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September 2021

Coronary Heart Disease (CHD) in Elderly Patients: Which Drug to Choose, Ticagrelor and Clopidogrel? A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

J Cardiovasc Dev Dis 2021 Sep 30;8(10). Epub 2021 Sep 30.

Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang 11800, Malaysia.

Background: A new generation P2Y12 receptor inhibitor (ticagrelor) is recommended in current therapeutic guidelines to treat patients with coronary heart disease (CHD). However, it is unknown if ticagrelor is more effective than clopidogrel in elderly patients. Therefore, a systematic review was done to assess the effectiveness and safety of ticagrelor and clopidogrel in older patients with CHD to determine the appropriate antiplatelet treatment plan. Read More

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September 2021

Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov.

Cancer Med 2021 Oct 22. Epub 2021 Oct 22.

Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, UK.

Background: Patient-reported adverse events (AEs) may be a useful adjunct to clinician-assessed AEs for assessing tolerability in early phase, dose-finding oncology trials (DFOTs). We reviewed DFOTs on ClinicalTrials.gov to describe trends in patient-reported outcome (PRO) use. Read More

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October 2021