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Gadolinium Tissue Distribution in a Large-Animal Model after a Single Dose of Gadolinium-based Contrast Agents.

Radiology 2021 Sep 21:210553. Epub 2021 Sep 21.

From the Diagnostic Imaging Research Unit, Clinic for Diagnostic Imaging, Department of Clinical Diagnostics and Services (H.R.), Clinic for Zoo Animals, Exotic Pets and Wildlife (L.F.M.), and Musculoskeletal Research Unit, Department of Molecular Mechanisms of Disease (A.K.), Vetsuisse Faculty, University of Zurich, Winterthurerstrasse 258c, 8057 Zurich, Switzerland; Clinic for Neuroradiology, University Hospital Bonn, Bonn, Germany (H.R., A.R.); Institute of Inorganic and Analytical Chemistry, University of Münster, Münster, Germany (P.B., C.D., S.F., M.S., U.K.); Clinical Neuroimaging, German Center for Neurodegenerative Diseases, Bonn, Germany (A.R.); and Institute of Neuropathology, University Hospital Münster, Münster, Germany (A.X., A.J.).

Background There is an ongoing scientific debate about the degree and clinical importance of gadolinium deposition in the brain and other organs after administration of gadolinium-based contrast agents (GBCAs). While most published data focus on gadolinium deposition in the brain, other organs are rarely investigated. Purpose To compare gadolinium tissue concentrations in various organs 10 weeks after one injection (comparable to a clinically applied dose) of linear and macrocyclic GBCAs in a large-animal model. Read More

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September 2021

Lesion-level heterogeneity of radiologic progression in patients treated with pembrolizumab.

Ann Oncol 2021 Sep 17. Epub 2021 Sep 17.

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA. Electronic address:

Background: Disease progression is often considered a binary state reflecting presence or absence of response. However, meaningful heterogeneity between metastatic sites of a given patient may exist and may impact therapeutic outcomes. To characterize the heterogeneity of progression with immunotherapy, we evaluated lesion-level dynamics of pembrolizumab-treated patients across three tumor types. Read More

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September 2021

Potential role of biochemical placentation markers - pregnancy associated plasma protein-A and human chorionic gonadotropin for early gestational diabetes screening - a pilot study.

Ginekol Pol 2021 Sep 20. Epub 2021 Sep 20.

Department of Internal Medicine, Medical University -Sofia, Sofia, Bulgaria;Clinic of Endocrinology, University Hospital, Sofia, Bulgaria.

Objectives: Gestational diabetes mellitus (GDM) is one of the most common pregnancy complications. The universal screening for GDM is usually performed between 24-28 weeks' gestation. This often delays the diagnosis and could increase the risk of adverse pregnancy outcomes. Read More

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September 2021

Masticatory Ability for a Single Implant Mandibular Overdenture Retained by Two Different Attachments: A Randomized Controlled Trial.

Int J Dent 2021 8;2021:1632848. Epub 2021 Sep 8.

Department of Prosthodontics, Faculty of Dentistry, Cairo University, Giza, Egypt.

Objective: The aim of this randomized clinical trial was to compare the masticatory ability subjectively between ball and Cendres+Métaux Locator (CM-LOC) attachment for a single implant retained mandibular overdenture throughout a 24-month follow-up period.

Materials And Methods: Eighty completely edentulous patients were recruited. All patients received new complete dentures, and masticatory ability was recorded using a questionnaire (baseline record). Read More

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September 2021

A multicentre double-blind, double-dummy, randomised study of recombinant human thrombopoietin versus eltrombopag in the treatment of immune thrombocytopenia in Chinese adult patients.

Br J Haematol 2021 Sep 16. Epub 2021 Sep 16.

Institute of Haematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.

We performed a double-blind, double-dummy controlled study to compare the efficacy between recombinant human thrombopoietin (rhTPO) and eltrombopag in rapidly increasing the platelet counts in Chinese patients with immune thrombocytopenia (ITP). A total of 96 patients diagnosed with ITP for ≥6 months who had baseline platelet counts of <30 × 10 /l were randomly assigned (1:1 ratio) to receive eltrombopag 25 mg/day or rhTPO 300 u/kg for 2 weeks. Compared with the eltrombopag group, a significantly higher proportion of patients in the rhTPO group achieved platelet counts of ≥50 × 10 /l [75·00% (36/48) vs. Read More

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September 2021

Time course of efficacy of atogepant for the preventive treatment of migraine: Results from the randomized, double-blind ADVANCE trial.

Cephalalgia 2021 Sep 14:3331024211042385. Epub 2021 Sep 14.

Neuroscience Development, AbbVie, Madison, NJ, USA.

Background: Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist for the preventive treatment of migraine.

Methods: In the double-blind, phase 3 ADVANCE trial, participants with 4-14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo once daily for 12 weeks. We evaluated the time course of efficacy of atogepant for the preventive treatment of migraine. Read More

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September 2021

A multi-disciplinary approach to weight management of school-age girls: a study protocol.

Pediatr Endocrinol Diabetes Metab 2021 ;27(2):76-81

Department of Community Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.

Introduction: There is lack of data about the combination of multiple approaches to control being overweight and obesity in adolescents. This study aimed to evaluate the effect of a combination program including smart-phone nutrition education, physical activity, and cognitive behavioral therapy (CBT) programs in the management of obesity and overweight among elementary school girls in comparison with a traditional education method.

Material And Methods: The primary outcome of this study is the assessment of changes in anthropometric data after 10 weeks. Read More

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September 2021

Perinatal factors influence on the neurocognitive development of children born small for gestational age (SGA) during the first 2 years of life.

Endocrinol Diabetes Nutr 2021 Sep 9. Epub 2021 Sep 9.

Unidad de Endocrinología Pediátrica, Hospital Universitario Infantil Miguel Servet, Zaragoza, España.

Background And Objective: Children born small for gestational age (SGA) show higher risk of neurodevelopmental and cognitive abnormalities. The objective of this study is to determine in children born SGA the neurodevelopment during the first 2 years of life and to establish the influence of anthropometric data, gestational age, multiple gestation and perinatal factors.

Patients And Method: Observational, prospective, descriptive and analytical study of the neurocognitive assessment performed, with Brunet-Lézine test, on SGA children (n=91) from 3 to 24 months of age, comparing with own controls. Read More

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September 2021

Timing of referral to peripheral nerve specialists in patients with postoperative C5 palsy.

J Clin Neurosci 2021 Oct 23;92:169-174. Epub 2021 Aug 23.

Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, NY 11030, USA. Electronic address:

The objective of this study was to examine the association between electrophysiology data post-C5-palsy and referral to peripheral nerve surgeons (PNS) using a 15-year cohort of patients who underwent posterior cervical decompression. Endpoints included the associations of postoperative treatments employed with functional recovery and abnormal electrophysiology data. Of 77 included patients (median 64 yr; 68% male), 48% completely recovered. Read More

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October 2021

Pyruvate-Driven Oxidative Phosphorylation is Downregulated in Sepsis-Induced Cardiomyopathy: A Study Of Mitochondrial Proteome.

Shock 2021 Sep 9. Epub 2021 Sep 9.

Translational Research Program, Department of Anesthesiology & Center for Shock, Trauma and Anesthesiology Research, Baltimore, MD, USA The Department of Physiology and Center for Biomedical Engineering and Technology, University of Maryland School of Medicine, Baltimore, MD, USA Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, USA.

Background: Sepsis-induced cardiomyopathy (SIC) is a major contributing factor for morbidity and mortality in sepsis. Accumulative evidence has suggested that cardiac mitochondrial oxidative phosphorylation is attenuated in sepsis, but the underlying molecular mechanisms remain incompletely understood.

Methods: Adult male mice of 9-12 weeks old were subjected to sham or cecal ligation and puncture procedure. Read More

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September 2021

A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence.

Int Urogynecol J 2021 Sep 9. Epub 2021 Sep 9.

Department of Obstetrics and Gynecology, Division of Urogynecology and Reconstructive Pelvic Surgery, University of North Carolina Medical Center, Chapel Hill, NC, USA.

Introduction And Hypothesis: To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4 weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts.

Methods: This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4 weeks in a 1:1 allocation ratio. Read More

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September 2021

Flash glucose monitoring and automated bolus calculation in type 1 diabetes treated with multiple daily insulin injections: a 26 week randomised, controlled, multicentre trial.

Diabetologia 2021 Sep 8. Epub 2021 Sep 8.

Steno Diabetes Center Copenhagen, Gentofte, Denmark.

Aims/hypothesis: We aimed to compare the effects of intermittently scanned continuous glucose monitoring (isCGM) and carbohydrate counting with automated bolus calculation (ABC) with usual care.

Methods: In a randomised, controlled, open-label trial carried out at five diabetes clinics in the Capital Region of Denmark, 170 adults with type 1 diabetes for ≥1 year, multiple daily insulin injections and HbA > 53 mmol/mol (7.0%) were randomly assigned 1:1:1:1 with centrally prepared envelopes to usual care (n = 42), ABC (n = 41), isCGM (n = 48) or ABC+isCGM (n = 39). Read More

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September 2021

The choice of operation timing of laparoscopic cholecystectomy (LC) after percutaneous transhepatic gallbladder drainage (PTGBD) for acute cholecystitis: a retrospective clinical analysis.

Ann Palliat Med 2021 Aug;10(8):9096-9104

Department of Hepatobiliary and Pancreatic Surgery, Tianjin Nankai Hospital, Tianjin, China.

Background: This study aimed to evaluate the timing of laparoscopic cholecystectomy (LC) after percutaneous transhepatic gallbladder drainage (PTGBD).

Methods: Patients with acute moderate to severe cholecystitis treated by LC after PTGBD in the Department of Hepatobiliary and Pancreatic Surgery, Nankai Hospital (N-362) between January 2017 and August 2019were retrospectively enrolled into this study. According to the interval times from PTGBD to LC, the patients were divided into six groups, including group A (105 cases, within 1 week), group B (62 cases, 1-2 weeks), group C (34 cases, 3-4 weeks), group D (54 cases, 5-8 weeks), group E (24 cases, 9-12 weeks), and group F (83 cases, over 12 weeks). Read More

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Association between timing and duration of breech presentation during pregnancy and developmental dysplasia of the hip: A case-control study.

J Child Health Care 2021 Sep 2:13674935211042198. Epub 2021 Sep 2.

Department of Health Technology and Services Research, 3230University of Twente, Enschede, The Netherlands.

This case-control study investigated the association between timing and duration of breech presentation in pregnancy and developmental dysplasia of the hip (DDH). Children with DDH aged 3 years or younger ( = 191) were compared with healthy controls ( = 209). Data on outcome, exposure and, covariates were collected using a parents' self-report online questionnaire. Read More

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September 2021

Prospective Study Testing a Simplified Paclitaxel Premedication Regimen in Patients with Early Breast Cancer.

Oncologist 2021 Sep 2. Epub 2021 Sep 2.

Dana-Farber Cancer Institute, Boston, MA, USA.

Background: In early trials, hypersensitivity reactions (HSRs) to paclitaxel were common, thus prompting the administration of antihistamines and corticosteroids before every paclitaxel dose. We tested the safety of omitting corticosteroids after cycle 2 during the paclitaxel portion of the dose-dense (DD) doxorubicin-cyclophosphamide (AC)-paclitaxel regimen.

Patients And Methods: In this prospective, single-arm study, patients who completed 4 cycles of DD-AC for stage I-III breast cancer received paclitaxel 175 mg/m2 every two weeks for 4 cycles. Read More

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September 2021

High Sustained Virologic Response Rates of Glecaprevir/Pibrentasvir in Patients With Dosing Interruption or Suboptimal Adherence.

Am J Gastroenterol 2021 09;116(9):1896-1904

NYU Langone Health, New York, New York, USA.

Introduction: Pangenotypic, all-oral direct-acting antivirals, such as glecaprevir/pibrentasvir (G/P), are recommended for treatment of hepatitis C virus (HCV) infection. Concerns exist about the impact on efficacy in patients with suboptimal adherence, particularly with shorter treatment durations. These post hoc analyses evaluated adherence (based on pill count) in patients prescribed 8- or 12-week G/P, the impact of nonadherence on sustained virologic response at post-treatment week 12 (SVR12), factors associated with nonadherence, and efficacy in patients interrupting G/P treatment. Read More

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September 2021

Effect of an oculomotor rehabilitation program for subacute brain injury patients with ophthalmoplegia: a case-control study.

Disabil Rehabil 2021 Aug 31:1-7. Epub 2021 Aug 31.

Rehabilitation Medicine, School of Medicine, Showa University, Shinagawa, Japan.

Purpose: Examining the effects of an oculomotor rehabilitation program in subacute brain injury patients presenting with external ophthalmoplegia.

Methods: This case-control study included 33 patients with subacute brain injury accompanied by external ophthalmoplegia (15 cases, 18 controls) from a hospital rehabilitation ward. Participants underwent comprehensive rehabilitation for 8 weeks. Read More

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Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder.

Hosp Pract (1995) 2021 Sep 3:1-8. Epub 2021 Sep 3.

Pear Therapeutics, Inc, Boston, MA, USA.

Purpose: To evaluate real-world prescription digital therapeutic (PDT) use and associated clinical outcomes among patients with opioid use disorder (OUD).

Patients And Methods: A real-world observational evaluation of patients who filled either a 12- or 24-week (refill) prescription for the reSET-O® PDT. The PDT content consists of 67 interactive lessons unlocked in sequence during use as well as the chance to earn rewards for progress and/or negative urine screens. Read More

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September 2021

Pain Catastrophizing and Kinesiophobia Affect Return to Sport in Patients Undergoing Hip Arthroscopy for the Treatment of Femoroacetabular Impingement.

Arthrosc Sports Med Rehabil 2021 Aug 27;3(4):e1087-e1095. Epub 2021 May 27.

Section of Young Adult Hip Surgery, Division of Sports Medicine, Department of Orthopedic Surgery, Hip Preservation Center, Rush University Medical Center, Chicago, Illinois, U.S.A.

Purpose: To assess whether pain catastrophizing and kinesiophobia affect return to sport (RTS) or clinically significant outcome (CSO) achievement in patients undergoing hip arthroscopy for the treatment of femoroacetabular impingement (FAI).

Methods: Patients undergoing primary hip arthroscopy at a single institution between January 2017 and March 2017 were prospectively enrolled. Patients received the Tampa Scale of Kinesiophobia-11 (TSK-11) and Pain Catastrophizing Scale (PCS) questionnaires preoperatively, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. Read More

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IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study.

EClinicalMedicine 2021 Sep 13;39:101088. Epub 2021 Aug 13.

Innovent Biologics, Suzhou, China.

Background: IBI362 (LY3305677) is a novel weekly-dose glucagon-like peptide-1 and glucagon receptor dual agonist being developed for the treatment of obesity and type 2 diabetes. The aim of this randomised, placebo-controlled, multiple ascending dose phase 1b study was to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI362 in Chinese adults with overweight or obesity.

Methods: This study enrolled adults with overweight (body mass index [BMI]≥24 kg/m) accompanied by hyperphagia and/or at least one comorbidity or obesity (BMI≥28 kg/m) from six study centres in China. Read More

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September 2021

Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma.

J Immunother Cancer 2021 Aug;9(8)

Department of Surgery, University of Virginia, Charlottesville, Virginia, USA

Background: We performed a clinical trial to evaluate safety and immunogenicity of a novel long peptide vaccine administered in combinations of incomplete Freund's adjuvant (IFA) and agonists for TLR3 (polyICLC) and TLR7/8 (resiquimod). We hypothesized that T cell responses to minimal epitope peptides (MEPs) within the long peptides would be enhanced compared with prior vaccines with MEP themselves and that T cell responses would be enhanced with TLR agonists, compared with IFA alone.

Methods: Participants with resected stage IIB-IV melanoma were vaccinated with seven long melanoma peptides (LPV7) from tyrosinase, gp100, MAGE-A1, MAGE-A10, and NY-ESO-1, each containing a known MEP for CD8 T cells, plus a tetanus helper peptide (Tet) restricted by Class II MHC. Read More

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Symptom control after different duration of triptorelin treatment following conservative surgery for deep infiltrating endometriosis: Post-hoc analysis of a multicentre, prospective, real-world study.

Medicine (Baltimore) 2021 Jul;100(30):e26753

Gynaecology Department, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.

Abstract: Triptorelin has been used after surgery in deep infiltrating endometriosis. This post-hoc analysis aimed to evaluate symptom control between patients receiving 1-3 triptorelin injections and those receiving 4-6 injections within 24 months of conservative surgery for deep infiltrating endometriosis, in the real-world.Included patients were divided into two groups (received up to 3 months injections in group A, 4-6 injections in group B) based on the numbers of triptorelin (Diphereline, 3. Read More

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Lipid profile of patients treated with evolocumab in Spanish hospital nephrology units (RETOSS NEFRO).

Nefrologia 2021 Aug 10. Epub 2021 Aug 10.

Servicio de Nefrología, Hospital Clínico Universitario, INCLIVA, Universidad de Valencia, Valencia, España.

Background And Objective: To describe the clinical characteristics, the reasons for initiating therapy and the effects of treatment in the initial phase of evolocumab availability in the Nephrology Units of Spain.

Material And Methods: Retrospective, observational and multicentric study that included patients initiating treatment with evolocumab (from February 2016 to August 2018), in 15 Nephrology Units in Spain. The demographic and clinical characteristics of the patients, the lipid lowering treatment and the evolution of the lipid profiles between 24 weeks pre-initiation and 12±4 weeks post-initiation of evolocumab were reviewed. Read More

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Feasibility and Preliminary Effects of the BESMILE-HF Program on Chronic Heart Failure Patients: A Pilot Randomized Controlled Trial.

Front Cardiovasc Med 2021 27;8:715207. Epub 2021 Jul 27.

Health Systems and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.

The Eight-Silken-Movements wIth Self-Efficacy building for Heart Failure (BESMILE-HF) program is a contextually adapted cardiac rehabilitation program. It uses a traditional Chinese exercise, , to solve the unmet demand of exercise-based cardiac rehabilitation programs due to their scarcity and unaffordability in China. This pilot study assesses BESMILE-HF's feasibility and preliminary effects. Read More

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Engagement patterns with a digital therapeutic for substance use disorders: Correlations with abstinence outcomes.

J Subst Abuse Treat 2021 Jul 30:108585. Epub 2021 Jul 30.

Pear Therapeutics, Boston, MA, United States of America.

Introduction: Patient engagement may play a key role in the success or failure of treatments for substance use disorder (SUD). This exploratory analysis of data from a large, multisite effectiveness trial (NCT01104805) sought to determine how patient engagement with a digital therapeutic for SUD delivered at clinics was associated with abstinence outcomes.

Methods: The study evaluated engagement for 206 participants enrolled in a treatment program for SUDs related to cocaine, alcohol, cannabis, or other stimulants who were randomized to receive treatment as usual (TAU) or reduced TAU plus the digital Therapeutic Education System (TES) for 12 weeks. Read More

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Impact of Prolonged Duration of Symptoms on Mental Health in Anterior Cervical Disectomy and Fusion Patients.

J Am Acad Orthop Surg 2021 Jul 30. Epub 2021 Jul 30.

From the Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL.

Introduction: Prolonged duration of symptoms is associated with worse pain and disability in patients undergoing anterior cervical discectomy and fusion (ACDF). Our study aims to determine the effect of symptom duration on severity of depression among ACDF patients.

Methods: We retrospectively reviewed a prospective surgical database from 2006 to 2019 for primary, single, or multilevel ACDF. Read More

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Phase II trial of proton therapy versus photon IMRT for GBM: secondary analysis comparison of progression-free survival between RANO versus clinical assessment.

Neurooncol Adv 2021 Jan-Dec;3(1):vdab073. Epub 2021 Jun 1.

Department of Radiation Oncology, MD Anderson Cancer Center, Houston, Texas, USA.

Background: This secondary image analysis of a randomized trial of proton radiotherapy (PT) versus photon intensity-modulated radiotherapy (IMRT) compares tumor progression based on clinical radiological assessment versus Response Assessment in Neuro-Oncology (RANO).

Methods: Eligible patients were enrolled in the randomized trial and had MR imaging at baseline and follow-up beyond 12 weeks from completion of radiotherapy. "Clinical progression" was based on a clinical radiology report of progression and/or change in treatment for progression. Read More

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Immunogenicity of varicella zoster vaccine in pediatric liver transplantation.

Pediatr Int 2021 Jul 29. Epub 2021 Jul 29.

Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

Background: Pediatric liver transplant (LT) candidates often miss complete VZV vaccination before LT. We aimed to evaluate the immunogenicity of two doses of VZV vaccines in pediatric LT candidates younger than 2 years and its persistence of immunogenicity after LT.

Methods: Patients aged 9-24 months were enrolled before LT. Read More

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Analysis of the prescription process of PCSK9 inhibitors in the cardiology departments of Spanish hospitals and optimization proposal. The IKIGAI study.

Clin Investig Arterioscler 2021 Jul 25. Epub 2021 Jul 25.

Servicio de Cardiología, Hospital Universitario de Bellvitge, Barcelona, España.

Aims: To ascertain the formalities and procedures required for the prescription of PCSK9 inhibitors in the cardiology departments of Spanish hospitals, making proposals for improvement to optimize the prescription process.

Methods: A first phase of collecting information about the variables and administrative procedures required for the prescription of PCK9 inhibitors and the elaboration of a specific questionnaire and a second phase of collecting data with an online self-administered questionnaire.

Results: A total of 88 hospitals participated in the study (mean number of beds 625; mean number of cardiologists 18 ± 10; 78% university hospitals). Read More

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Effect of Bevacizumab in Combination With Standard Oxaliplatin-Based Regimens in Patients With Metastatic Colorectal Cancer: A Randomized Clinical Trial.

JAMA Netw Open 2021 Jul 1;4(7):e2118475. Epub 2021 Jul 1.

Experimental Pharmacology Unit, Istituto Nazionale Tumori-IRCCS, Fondazione G. Pascale, Napoli, Italy.

Importance: Although bevacizumab is a standard of care in combination treatments for metastatic colorectal cancer (mCRC), its clinical benefit has been limited.

Objective: To determine whether sequential scheduling of bevacizumab administration in combination with chemotherapy improves treatment efficacy in patients with mCRC, in keeping with the tumor vascular normalization hypothesis.

Design, Setting, And Participants: This open-label, randomized clinical phase 3 trial was conducted from May 8, 2012, to December 9, 2015, at 3 Italian centers. Read More

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