19,262 results match your criteria secondary endpoints


Revascularization decisions in patients with chronic coronary syndromes: Results of the second international survey on interventional strategy (ISIS-2).

Int J Cardiol 2021 May 7. Epub 2021 May 7.

Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy; Cardiovascular Research Center Aalst, OLV-Clinic Aalst, Aalst, Belgium.

Background: In chronic coronary syndromes, guidelines mandate invasive functional guidance of revascularization whenever non-invasive proof of ischemia is missing. ISIS-2 survey aimed to evaluate how the adoption of guideline recommendation on ischemia-guided revascularization has evolved over the last 5-7 years.

Methods: In ISIS-2 participants assessed five complete angiograms, presenting only intermediate stenoses without information on non-invasive pre-testing. Read More

View Article and Full-Text PDF

Long-term outcome of 177Lu-PSMA-617 radioligand therapy in heavily pre-treated metastatic castration-resistant prostate cancer patients.

PLoS One 2021 10;16(5):e0251375. Epub 2021 May 10.

Department of Nuclear Medicine, Thyroid Clinic, AIIMS, Ansari Nagar, New Delhi, India.

Objective: Investigators have extensively explored the short-term safety and efficacy data on 177Lu-PSMA-617 radioligand therapy (RLT) in mCRPC patients. However, scarce literature is reported on the long-term outcome of these patients. The current goal of this study is focused on the long-term outcome of mCRPC patients treated with 177Lu-PSMA-617 RLT. Read More

View Article and Full-Text PDF

Periprocedural Outcomes of Popliteal vs Upper Extremity Access in the Treatment of Superficial Femoral Artery Occlusive Disease.

J Endovasc Ther 2021 May 10:15266028211012402. Epub 2021 May 10.

Department of Surgery, Lenox Hill Hospital, Northwell Health, New York, NY, USA.

Purpose: Percutaneous lower extremity revascularization is being performed via upper extremity, pedal, or popliteal access with increasing frequency. This study aimed to compare periprocedural outcomes of popliteal (POA) and upper extremity (UEA) access for the treatment of isolated superficial femoral artery (SFA) occlusive disease.

Materials And Methods: A retrospective cohort study compared the outcomes of patients undergoing primary percutaneous intervention of SFA occlusive disease with POA or UEA using the Vascular Quality Initiative database from December 2010 to June 2019. Read More

View Article and Full-Text PDF

Impact of early (<7 days) pacemaker implantation after cardiac surgery on long-term pacemaker dependency.

Pacing Clin Electrophysiol 2021 May 9. Epub 2021 May 9.

Department of Cardiology, University Hospital Besançon, Boulevard Fleming, Besançon, 25000, France.

Objective: We aimed to investigate pacemaker dependency after at least 1 year in patients with early (<7 days) implantation, compared to those who received a pacemaker ≥7 days after surgery. Secondary endpoints were length of hospital stay and in-hospital complications.

Methods: Retrospective analysis of 108 consecutive patients who received a pacemaker after cardiac surgery between 06/2012 and 06/2018. Read More

View Article and Full-Text PDF

Efficacy and Safety of Orally Administered Acotiamide Extended-Release Tablets Among Functional Dyspepsia-Postprandial Distress Syndrome Patients: A Randomized, Double-Blind, Multicenter Study.

Cureus 2021 Apr 8;13(4):e14361. Epub 2021 Apr 8.

Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.

Background: Acotiamide, is the world's first-in-class, prokinetic drug and world's first approved treatment for postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). An extended-release (ER) formulation of this drug product, developed first-time in the world has been evaluated in phase 3, a comparative trial to explore the efficacy and safety in patients with FD-PDS.

Methods: In this study, 219 patients with FD-PDS aged 18-65 years were randomized (1:1) to receive either acotiamide ER 300 mg once daily or acotiamide 100 mg three times daily for four weeks. Read More

View Article and Full-Text PDF

A 30-Year Study of Impacts, Recovery, and Development of Critical Effect Sizes for Endocrine Disruption in White Sucker () Exposed to Bleached-Kraft Pulp Mill Effluent at Jackfish Bay, Ontario, Canada.

Front Endocrinol (Lausanne) 2021 22;12:664157. Epub 2021 Apr 22.

Biological Sciences, University of Calgary, Calgary, AB, Canada.

Jackfish Bay is an isolated bay on the north shore of Lake Superior, Canada that has received effluent from a large bleached-kraft pulp mill since the 1940s. Studies conducted in the late 1980s found evidence of reductions in sex steroid hormone levels in multiple fish species living in the Bay, and increased growth, condition and relative liver weights, with a reduction in internal fat storage, reduced gonadal sizes, delayed sexual maturation, and altered levels of circulating sex steroid hormones in white sucker (). These early studies provided some of the first pieces of evidence of endocrine disruption in wild animals. Read More

View Article and Full-Text PDF

Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Peg IFN Beta-1a (Pre-filled Pen) in Subjects With Relapsing-Remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM Study).

Front Neurol 2021 22;12:637615. Epub 2021 Apr 22.

Biogen Italia, Milan, Italy.

Subcutaneous (SC) interferons beta (IFN-beta) are effective therapies for the treatment of relapsing-remitting multiple sclerosis (RRMS). Factors such as dosing schedule, needle intolerance/fatigue, and side effects may impact patient satisfaction with treatment. Improvement of patient satisfaction may increase the adherence to treatment and the patient quality of life. Read More

View Article and Full-Text PDF

Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study.

Chin Med J (Engl) 2021 May 6. Epub 2021 May 6.

Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 10021, China Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 20003, China Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510060, China Department of Medical Oncology, 307 Hospital of Chinese People's Liberation Army, Beijing 100071, China Department of Lymphoma, Peking University Cancer Hospital & Institute, Beijing 100142, China Department of Hematology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China Department of Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer, Nanjing, Jiangsu 210009, China Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450052, China Department of Hematology, The First Affiliated Hospital of Zhejiang University College of Medicine, Hangzhou, Zhejiang 310003, China Department of Hematology, Peking University Third Hospital, Beijing 100191, China Department of Oncology, Jilin University First Affiliated Hospital, Changchun, Jilin 130021, China Department of Hematology, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, China Department of Hematology, Peking University Institute of Hematology, Peking University People's Hospital, Beijing 100044, China Department of Hematology, Guangdong General Hospital, Guangzhou, Guangdong 510062, China Department of Hematology and Research Laboratory of Hematology, West China Hospital of Sichuan University, Chengdu, Sichuan 610041, China Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang 150001, China Department of Hematology, Chinese PLA General Hospital, Beijing 100038, China Department of Hematology, Shanghai Ruijin Hospital, Shanghai 200020, China Department of Hematology, The Second Hospital of Lanzhou University, Lanzhou, Gansu 730030, China Department of Drug Metabolism and Pharmacokinetics, Teva Branded Pharmaceutical Products R&D Inc., West Chester, PA 19380, USA.

Background: Bendamustine was approved in China on May 26th, 2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma (NHL). The current study was the registration trial and the first reported evaluation of the efficacy, safety, and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.

Methods: This was a prospective, multicenter, open-label, single-arm, phase 3 study (NCT01596621; C18083/3076) with a 2-year follow-up period. Read More

View Article and Full-Text PDF

Atrial fibrillation increases the risk of recurrent ventricular tachyarrhythmias in implantable cardioverter defibrillator recipients.

Arch Cardiovasc Dis 2021 May 6. Epub 2021 May 6.

First Department of Medicine, University Medical Centre Mannheim (UMM), Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany.

Background: Data regarding recurrences of ventricular tachyarrhythmias in implantable cardioverter defibrillator (ICD) recipients according to atrial fibrillation is limited.

Objective: To assess the prognostic impact of atrial fibrillation on recurrences of ventricular tachyarrhythmias in implantable cardioverter defibrillator recipients.

Methods: A large retrospective registry was used, including all ICD recipients with episodes of ventricular tachycardia or fibrillation from 2002 to 2016. Read More

View Article and Full-Text PDF

Comparison between different types of exercise training in patients with type 2 diabetes mellitus: A systematic review and network metanalysis of randomized controlled trials.

Nutr Metab Cardiovasc Dis 2021 Mar 20. Epub 2021 Mar 20.

Diabetology, Careggi Hospital, Florence, Italy. Electronic address:

Aim: Aim of the present meta-analysis and network metanalysis (NMA) is the assessment of the effects of physical exercise on glucose control and cardiovascular risk factors in type 2 diabetes.

Data Synthesis: This metanalysis includes all available trials exploring the effects of different exercise modalities in type 2 diabetes, with a duration of ≥3 months. The standardized difference in means (SDM) with 95% Confidence Intervals were calculated. Read More

View Article and Full-Text PDF

Long-term safety of lumacaftor-ivacaftor in children aged 2-5 years with cystic fibrosis homozygous for the F508del-CFTR mutation: a multicentre, phase 3, open-label, extension study.

Lancet Respir Med 2021 May 6. Epub 2021 May 6.

Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Stanley Manne Children's Research Institute, Chicago, IL, USA; Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.

Background: A previous phase 3 study showed that lumacaftor-ivacaftor was generally safe and well tolerated over 24 weeks of treatment in children aged 2-5 years with cystic fibrosis homozygous for the F508del-CFTR mutation. In this study, we aimed to assess the long-term safety of lumacaftor-ivacaftor in a rollover study of children who participated in this previous phase 3 study.

Methods: In this multicentre, phase 3, open-label, extension study (study 116; VX16-809-116), we assessed safety of lumacaftor-ivacaftor in children included in a previous multicentre, phase 3, open-label study (study 115; VX15-809-115). Read More

View Article and Full-Text PDF

Delivering clinical trials at home: protocol, design and implementation of a direct-to-family paediatric lupus trial.

Lupus Sci Med 2021 May;8(1)

Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA

Introduction: Direct-to-family clinical trials efficiently provide data while reducing the participation burden for children and their families. Although these trials can offer significant advantages over traditional clinical trials, the process of designing and implementing direct-to-family studies is poorly defined, especially in children with rheumatic disease. This paper provides lessons learnt from the design and implementation of a self-controlled, direct-to-family pilot trial aimed to evaluate the effects of a medication management device on adherence to hydroxychloroquine in paediatric SLE. Read More

View Article and Full-Text PDF

Monitoring of patients with microdialysis following pancreaticoduodenectomy-the MINIMUM study: study protocol for a randomized controlled trial.

Trials 2021 May 7;22(1):329. Epub 2021 May 7.

Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway.

Background: Postoperative pancreatic fistula after pancreatoduodenectomy is a much-feared complication associated with substantial mortality and morbidity. The current standard for diagnosing postoperative pancreatic fistula, besides routine clinical examination, include radiological examinations, analysis of pancreatic drain amylase activity, and routine blood samples. Another promising method is by intraperitoneal microdialysis to monitor intraperitoneal metabolites measured at the pancreaticojejunostomy, thereby detecting what occurs locally, before chemical events can be reflected as measurable changes in systemic blood levels. Read More

View Article and Full-Text PDF

Checkpoint inhibition in combination with an immunoboost of external beam radiotherapy in solid tumors (CHEERS): study protocol for a phase 2, open-label, randomized controlled trial.

BMC Cancer 2021 May 7;21(1):514. Epub 2021 May 7.

Cancer Research Institute Ghent (CRIG), Ghent University, Ghent, Belgium.

Background: While the introduction of checkpoint inhibitors (CPIs) as standard of care treatment for various tumor types has led to considerable improvements in clinical outcome, the majority of patients still fail to respond. Preclinical data suggest that stereotactic body radiotherapy (SBRT) could work synergistically with CPIs by acting as an in situ cancer vaccine, thus potentially increasing response rates and prolonging disease control. Though SBRT administered concurrently with CPIs has been shown to be safe, evidence of its efficacy from large randomized trials is still lacking. Read More

View Article and Full-Text PDF

Phase 3 multicenter randomized trial of PSMA PET/CT prior to definitive radiation therapy for unfavorable intermediate-risk or high-risk prostate cancer [PSMA dRT]: study protocol.

BMC Cancer 2021 May 7;21(1):512. Epub 2021 May 7.

Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Hufelandstraße 55, 45131, Essen, Germany.

Background: Definitive radiation therapy (dRT) is an effective initial treatment of intermediate-risk (IR) and high-risk (HR) prostate cancer (PCa). PSMA PET/CT is superior to standard of care imaging (CT, MRI, bone scan) for detecting regional and distant metastatic PCa. PSMA PET/CT thus has the potential to guide patient selection and the planning for dRT and improve patient outcomes. Read More

View Article and Full-Text PDF

Thoracic radiotherapy and concurrent almonertinib for unresectable stage III EGFR-mutated non-small-cell lung cancer: a phase 2 study.

BMC Cancer 2021 May 7;21(1):511. Epub 2021 May 7.

Department of Thoracic Oncology, Key Laboratory of Clinical Cancer Pharmacology and Toxicology Research of Zhejiang Province, Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine, Hangzhou, 310002, People's Republic of China.

Background: Concurrent chemo-radiotherapy remains the standard treatment in unresectable stage III non-small-cell lung cancer (NSCLC) patients. Several studies have shown a potential value of concurrent epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) with thoracic radiotherapy in EGFR-mutated population, but a high risk of radiation pneumonitis raised a major concern. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI, with radiotherapy in locally advanced EGFR-mutated NSCLC patients. Read More

View Article and Full-Text PDF

The analgesic efficacy of forearm vfversus upper arm intravenous regional anesthesia (Bier's block): A randomized controlled non-inferiority trial.

J Clin Anesth 2021 May 5;73:110329. Epub 2021 May 5.

Department of Anaesthesiology and Pain Medicine, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, Diepenbeek, Belgium.

Study Objective: This study aimed to assess if a forearm (FA) intravenous regional anesthesia (IVRA) with a lower, less toxic, local anesthetic dosage is non-inferior to an upper arm (UA) IVRA in providing a surgical block in patients undergoing hand and wrist surgery.

Design: Observer-blinded, randomized non-inferiority study.

Setting: Operating room. Read More

View Article and Full-Text PDF

A phase 1b/2a, open-label, multiple ascending dose trial of domagrozumab in FKRP limb-girdle muscular dystrophy.

Muscle Nerve 2021 May 7. Epub 2021 May 7.

Center for Genetic Muscle Disorders, Kennedy Krieger Institute, Baltimore, MD.

Introduction: We report the results of a phase 1b/2a, open-label, multiple ascending dose trial of domagrozumab, a myostatin inhibitor, in patients with FKRP-associated limb-girdle muscular dystrophy.

Methods: Nineteen patients were enrolled and assigned to one of three dosing arms (5 mg/kg, 20mg/kg, or 40mg/kg every 4 weeks). Following 32 weeks of treatment, participants receiving the lowest dose were switched to the highest dose (40mg/kg) for an additional 32 weeks. Read More

View Article and Full-Text PDF

Diverse changes in microglia morphology and axonal pathology during the course of 1 year after mild traumatic brain injury in pigs.

Brain Pathol 2021 May 7:e12953. Epub 2021 May 7.

Center for Neurotrauma, Neurodegeneration & Restoration, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.

Over 2.8 million people experience mild traumatic brain injury (TBI) in the United States each year, which may lead to long-term neurological dysfunction. The mechanical forces that are caused by TBI propagate through the brain to produce diffuse axonal injury (DAI) and trigger secondary neuroinflammatory cascades. Read More

View Article and Full-Text PDF

A phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (SUBDUE-1, SUB-urothelial DUrvalumab injection-1 study): clinical trial protocol.

BJU Int 2021 May 6. Epub 2021 May 6.

University of Western Australia (UWA) Medical School, University of Western Australia, Perth, WA, Australia.

Objectives: This article presents the clinical trial protocol for a phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (NMIBC), the SUB-urothelial DUrvalumab injection-1 study (SUBDUE-1). The primary objectives of this study are to assess the safety of sub-urothelial injection of durvalumab using patient reported outcome measures and observed local or systemic adverse events. The secondary objectives are to examine the local immunological efficacy of sub-urothelial administration of durvalumab. Read More

View Article and Full-Text PDF

Model for End-Stage Liver Disease Score Predicts the Mortality of Patients with Coronary Heart Disease Who Underwent Percutaneous Coronary Intervention.

Cardiol Res Pract 2021 17;2021:6401092. Epub 2021 Apr 17.

Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.

Background: Coronary heart disease (CHD) is caused by the blockage or spasm of coronary arteries. Evidence shows that liver disease is related to CHD. However, the correlation between the Model for End-Stage Liver Disease (MELD) score and outcomes in patients after percutaneous coronary intervention (PCI) was unclear. Read More

View Article and Full-Text PDF

Beneficial Potential of for Stress-Sensitive Functional Dyspepsia via Modulation of Ghrelin: A Randomized Controlled Trial.

Front Pharmacol 2021 20;12:636752. Epub 2021 Apr 20.

Liver and Immunology Research Center, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.

Functional dyspepsia (FD) is a highly complex pathophysiologic disease, which shows low recovery and high relapse rates. Therefore, a growing number of clinicians and patients are looking for alternative herbal medicine. (BST) is an herbal prescription for treating a wide range of dyspepsia in traditional Korean medicine (TKM). Read More

View Article and Full-Text PDF

Infant formula containing bovine milk-derived oligosaccharides supports age-appropriate growth and improves stooling pattern.

Pediatr Res 2021 May 6. Epub 2021 May 6.

Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.

Background: Adding bovine milk-derived oligosaccharides (MOS) enhances the oligosaccharide profile of infant formula. This study aimed to evaluate the safety and efficacy of a MOS-supplemented infant formula.

Methods: In this double-blind randomized controlled trial, healthy infants 21-26 days old were either assigned to bovine milk-based, alpha-lactalbumin, and sn-2 palmitate enriched infant formula (control, n = 115) or the same formula with 7. Read More

View Article and Full-Text PDF

Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial.

Obstet Gynecol 2021 May 6. Epub 2021 May 6.

Department of Obstetrics, the Department of Biostatistics and Methodology, the Department of Neonatal Medicine, the Department of Reproductive Medicine, Angers University Hospital, and the MITOVASC Institute, CNRS 6015, INSERM U1083, Angers University, Angers, and CESP-INSERM, U1018, Team 7, Reproductive and Sexual Health, Paris-Sud University, Kremlin-Bicêtre, France.

Objective: To evaluate whether manual rotation of fetuses in occiput posterior positions at full dilation increases the rate of spontaneous vaginal delivery.

Methods: In an open, single-center, randomized controlled trial, patients with a term, singleton gestation, epidural analgesia, and ultrasonogram-confirmed occiput posterior position at the start of the second stage of labor were randomized to either manual rotation or expectant management. Our primary endpoint was the rate of spontaneous vaginal delivery. Read More

View Article and Full-Text PDF

Topical Imiquimod for the Treatment of High-Grade Squamous Intraepithelial Lesions of the Cervix: A Randomized Controlled Trial.

Obstet Gynecol 2021 May 6. Epub 2021 May 6.

Department of Prevention, the Department of Gynecological Oncology, the Department of Pathology, and the Research and Teaching Institute, Barretos Cancer Hospital, Barretos, São Paulo, Brazil; the Department of Gynecologic Oncology and Reproductive Medicine, the University of Texas MD Anderson Cancer Center, Houston, Texas; the Department of Obstetrics and Gynecology, Federal University of Health Sciences of Porto Alegre/Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Brazil; and the Teaching Superintendence, A.C. Camargo Cancer Center, São Paulo, Brazil.

Objective: To evaluate the histologic response rate of high-grade squamous intraepithelial lesions (HSIL) of the cervix after topical application of 5% imiquimod cream.

Methods: In this phase II trial, women with cervical HSIL (cervical intraepithelial neoplasia [CIN] 2-3) were randomly assigned to 250 mg of 5% imiquimod cream applied to the cervix weekly for 12 weeks, followed by loop electrosurgical excision procedure (LEEP) without preceding treatment. The sample size was calculated based on the HSIL regression rates previously reported by Grimm et al. Read More

View Article and Full-Text PDF

Outcomes of endovenous laser ablation with additional iliac vein stenting of non-thrombotic lesions in patients presenting with active venous ulcers.

J Vasc Surg Venous Lymphat Disord 2021 May 3. Epub 2021 May 3.

Department of Vascular Surgery, Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine; Vascular Center of Shanghai JiaoTong University, Shanghai 200011, China. Electronic address:

Objective: To evaluate the clinical outcomes of superficial and perforator ablation and the impact on wound healing by adding iliac vein stenting of non-thrombotic iliac vein lesions (NIVLs) in patients presenting with active venous ulcers.

Methods And Materials: A retrospective analysis was performed from January 2017 to December 2019, examining patients presenting with venous ulcers who were diagnosed with NIVLs. Patients with> 50% diameter reduction in the iliac vein based on computed tomography venogram underwent transfemoral venography for further confirmation. Read More

View Article and Full-Text PDF

Low dose radiation therapy for severe COVID-19 pneumonia: a randomized double-blind study.

Int J Radiat Oncol Biol Phys 2021 May 3. Epub 2021 May 3.

Clinic of Intensive Care Medicine, University Hospital Basel, Basel, Switzerland.

Purpose: The morbidity and mortality of patients requiring mechanical ventilation for coronavirus disease 2019 (COVID-19) pneumonia is considerable. We studied the use of whole-lung low dose radiation therapy (LDRT) in this patient cohort.

Methods And Materials: Patients admitted to the intensive care unit (ICU) and requiring mechanical ventilation for COVID-19 pneumonia were included in this randomized double-blind study. Read More

View Article and Full-Text PDF

Serum creatinine and cystatin C-based estimates of glomerular filtration rate are misleading in acute heart failure.

ESC Heart Fail 2021 May 6. Epub 2021 May 6.

Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.

Aims: We aimed to test whether the endogenous filtration markers serum creatinine or cystatin C and equation-based estimates of glomerular filtration rate (GFR) based on these markers appropriately reflect changes of measured GFR in patients with acute heart failure.

Methods: In this prospective cohort study of 50 hospitalized acute heart failure patients undergoing decongestive therapy, we applied an intravenous visible fluorescent injectate (VFI), consisting of a low molecular weight component to measure GFR and a high molecular weight component to correct for measured plasma volume. Thirty-eight patients had two sequential GFR measurements 48 h apart. Read More

View Article and Full-Text PDF

The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

Eur J Clin Invest 2021 May 6:e13570. Epub 2021 May 6.

Heart Team Vienna, Department of Cardio-Vascular Surgery, Clinic Floridsdorf and the Karl Landsteiner Institute for Cardio-Vascular Research, Vienna, Austria.

Background: This study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR).

Methods: 251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. Read More

View Article and Full-Text PDF

Randomised controlled trial of oxygen therapy and high-flow nasal therapy in African children with pneumonia.

Intensive Care Med 2021 May 5. Epub 2021 May 5.

Intensive Care National Audit and Research Centre, London, UK.

Purpose: The life-saving role of oxygen therapy in African children with severe pneumonia is not yet established.

Methods: The open-label fractional-factorial COAST trial randomised eligible Ugandan and Kenyan children aged > 28 days with severe pneumonia and severe hypoxaemia stratum (SpO < 80%) to high-flow nasal therapy (HFNT) or low-flow oxygen (LFO: standard care) and hypoxaemia stratum (SpO 80-91%) to HFNT or LFO (liberal strategies) or permissive hypoxaemia (ratio 1:1:2). Children with cyanotic heart disease, chronic lung disease or > 3 h receipt of oxygen were excluded. Read More

View Article and Full-Text PDF