11,748 results match your criteria multicentre prospective


Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study.

Diabetes Ther 2021 Sep 25. Epub 2021 Sep 25.

Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.

Introduction: Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evaluated the use of OW semaglutide in a real-world patient population with type 2 diabetes (T2D) in the UK.

Methods: In this prospective, observational study, adults (≥ 18 years) with ≥ 1 documented glycated haemoglobin (HbA) value ≤ 12 weeks before semaglutide initiation were enrolled. Read More

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September 2021

BESPOKE study protocol: a multicentre, prospective observational study to evaluate the impact of circulating tumour DNA guided therapy on patients with colorectal cancer.

BMJ Open 2021 Sep 24;11(9):e047831. Epub 2021 Sep 24.

Natera Inc, San Carlos, California, USA

Introduction: Colorectal cancer (CRC) is a highly prevalent disease, wherein, ~30%-40% of patients with CRC relapse postresection. In some patients with CRC, adjuvant chemotherapy can help delay recurrence or be curative. However, current biomarkers show limited clinical utility in determining if/when chemotherapy should be administered, to provide benefit. Read More

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September 2021

Contribution of lung ultrasound in diagnosis of community-acquired pneumonia in the emergency department: a prospective multicentre study.

BMJ Open 2021 Sep 24;11(9):e046849. Epub 2021 Sep 24.

Emergency Department, Centre Hospitalier Universitaire de Nantes, Nantes, France

Lung ultrasound (LUS) can help clinicians make a timely diagnosis of community-acquired pneumonia (CAP).

Objectives: To assess if LUS can improve diagnosis and antibiotic initiation in emergency department (ED) patients with suspected CAP.

Design: A prospective observational study. Read More

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September 2021

A prospective open-label, multicentre study evaluating a non-cross-linked hyaluronic acid based soft-tissue filler in the correction of lateral canthal and perioral lines.

J Cosmet Dermatol 2021 Sep 24. Epub 2021 Sep 24.

Department for Hand, Plastic and Aesthetic Surgery, Ludwig - Maximilian University Munich, Munich, Germany.

Objective: The aim of this investigation was to assess the effectiveness of a non-cross-linked hyaluronic acid based soft-tissue filler in the correction of lateral canthal lines and periorbital lines.

Material And Methods: A total of 59 female Caucasian patients with a mean age of 52.6 ± 9. Read More

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September 2021

Is patient participation in multidisciplinary tumour conferences associated with their information needs? A multicentre prospective observational study.

BMJ Open 2021 Sep 23;11(9):e049199. Epub 2021 Sep 23.

Center for Health Communication and Health Services Research, Department for Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.

Objectives: To determine the association between participation of patients with breast cancer and patients with gynaecological cancer in their own multidisciplinary tumour conference (MTC) and their information needs with regard to their disease and treatment options.

Methods: This is a prospective observational study that took place at six breast cancer and gynaecological cancer centres in North Rhine-Westphalia, Germany. Patient inclusion criteria included a minimum age of 18 years and at least one diagnosis of breast cancer or gynaecological cancer. Read More

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September 2021

A prospective population-based multicentre study on the impact of maternal body mass index on adverse pregnancy outcomes: Focus on normal weight.

PLoS One 2021 23;16(9):e0257722. Epub 2021 Sep 23.

Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.

Background: Maternal body mass index (BMI) below or above the reference interval (18.5-24.9 kg/m2) is associated with adverse pregnancy outcomes. Read More

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September 2021

Variability in estimated glomerular filtration rate and patients' outcomes in a real-world heart failure population.

ESC Heart Fail 2021 Sep 23. Epub 2021 Sep 23.

Department of Nephrology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.

Aims: The prognostic significance of renal function variability has not been fully elucidated in heart failure (HF). This multicentre, prospective cohort study aimed to evaluate the usefulness of visit-to-visit variability in estimated glomerular filtration rate (eGFR) for predicting patients' outcomes in a real-world HF population.

Methods: A total of 564 patients who had survived HF hospitalization were randomly assigned with a 2:1 ratio to derivation and validation cohorts, and they were then followed after discharge. Read More

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September 2021

Implementation of an adapted Sepsis Risk Calculator algorithm to reduce antibiotic usage in the management of early onset neonatal sepsis: a multicentre initiative in Wales, UK.

Arch Dis Child Fetal Neonatal Ed 2021 Sep 22. Epub 2021 Sep 22.

Department of Neonatal Medicine, Singleton Hospital, Swansea, UK

Objective: Assess the impact of introducing a consensus guideline incorporating an adapted Sepsis Risk Calculator (SRC) algorithm, in the management of early onset neonatal sepsis (EONS), on antibiotic usage and patient safety.

Design: Multicentre prospective study SETTING: Ten perinatal hospitals in Wales, UK.

Patients: All live births ≥34 weeks' gestation over a 12-month period (April 2019-March 2020) compared with infants in the preceding 15-month period (January 2018-March 2019) as a baseline. Read More

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September 2021

Outcomes of early repeat sweat testing in infants with cystic fibrosis transmembrane conductance regulator-related metabolic syndrome (CRMS)/CF screen-positive, inconclusive diagnosis (CFSPID).

Pediatr Pulmonol 2021 Sep 22. Epub 2021 Sep 22.

Cystic Fibrosis Regional Support Center, Department of Pediatrics, University of Brescia, ASST Spedali Civili Brescia, Brescia, Italy.

Background: Reaching early and definitive diagnosis in infants with cystic fibrosis (CF) transmembrane conductance regulator-related metabolic syndrome (CRMS)/CF screen-positive, inconclusive diagnosis (CFSPID) is a priority of all CF newborn screening programs. Currently, sweat testing is the gold standard for CF diagnosis or exclusion. We assessed outcomes in a cohort of Italian CRMS/CFSPID infants who underwent repeat sweat testing in the first year of life. Read More

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September 2021

Treatment abandonment: A report from the collaborative African network for childhood cancer care and research-CANCaRe Africa.

Pediatr Blood Cancer 2021 Sep 21:e29367. Epub 2021 Sep 21.

Queen Elizabeth Central Hospital (QECH), College of Medicine, Blantyre, Malawi.

Background: 'Treatmentabandonment' is a common and preventable cause of childhood cancer treatment failure in low- and middle-income countries (LMIC). Risk factors and effective interventions in LMIC are reported. Poverty and costs of treatment are perceived as overriding causes in sub-Saharan Africa. Read More

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September 2021

Adjuvant Chemotherapy in the Treatment of Intraductal Papillary Mucinous Neoplasms of the Pancreas: Systematic Review and Meta-Analysis.

World J Surg 2021 Sep 20. Epub 2021 Sep 20.

Pancreatic and Transplant Surgery, HPB and Transplant Unit, Department of Hepatobiliary, Freeman Hospital, Newcastle upon Tyne, UK.

Background: The present systematic review aimed to compare survival outcomes of invasive intraductal papillary mucinous neoplasms (IIPMNs) treated with adjuvant chemotherapy versus surgery alone and to identify pathologic features that may predict survival benefit from adjuvant chemotherapy.

Method: A systematic search of MEDLINE, PubMed, Scopus, and EMBASE was performed using the PRISMA framework. Studies comparing adjuvant chemotherapy and surgery alone for patients with IIPMNs were included. Read More

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September 2021

Prospective, double-blind diagnostic multicentre study of confocal laser endomicroscopy for wheat sensitivity in patients with irritable bowel syndrome.

Gut 2021 Sep 20. Epub 2021 Sep 20.

Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Campus Benjamin Franklin, Department for Internal Medicine (Gastroenterology, Infectious Diseases, Rheumatology, Berlin, Germany.

Objective: A considerable proportion of patients with irritable bowel syndrome (IBS) may be wheat-sensitive and respond to a gluten-free diet (GFD) although they do not have coeliac disease. However, a diagnostic test for wheat sensitivity (WS) is missing. Our study evaluated the diagnostic accuracy (sensitivity and specificity) of confocal laser endomicroscopy (CLE) for the identification of WS as primary outcome. Read More

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September 2021

Immunological assessment of SARS-CoV-2 infection in pregnancy from diagnosis to delivery: A multicentre prospective study.

PLoS One 2021 20;16(9):e0253090. Epub 2021 Sep 20.

UCD School of Medicine, National Maternity Hospital, Dublin, Ireland.

Background: Background Population-based data on SARS-CoV-2 infection in pregnancy and assessment of passive immunity to the neonate, is lacking. We profiled the maternal and fetal response using a combination of viral RNA from naso-pharyngeal swabs and serological assessment of antibodies against SARS-CoV-2.

Methods: This multicentre prospective observational study was conducted between March 24th and August 31st 2020. Read More

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September 2021

Blinded study: prospectively defined high-frequency oscillations predict seizure outcome in individual patients.

Brain Commun 2021 2;3(3):fcab209. Epub 2021 Sep 2.

Klinik für Neurochirurgie, UniversitätsSpital Zürich, Universität Zürich, Zürich, Switzerland.

Interictal high-frequency oscillations are discussed as biomarkers for epileptogenic brain tissue that should be resected in epilepsy surgery to achieve seizure freedom. The prospective classification of tissue sampled by individual electrode contacts remains a challenge. We have developed an automated, prospective definition of clinically relevant high-frequency oscillations in intracranial EEG from Montreal and tested it in recordings from Zurich. Read More

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September 2021

Functional and Oncological Outcomes After Open Versus Robot-assisted Laparoscopic Radical Prostatectomy for Localised Prostate Cancer: 8-Year Follow-up.

Eur Urol 2021 Sep 15. Epub 2021 Sep 15.

Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Surgery, Sahlgrenska University Hospital-Västra Götaland/Östra, Gothenburg, Sweden.

Background: Radical prostatectomy reduces mortality among patients with localised prostate cancer. Evidence on whether different surgical techniques can affect mortality rates is lacking.

Objective: To evaluate functional and oncological outcomes 8 yr after robot-assisted laparoscopic prostatectomy (RALP) and open retropubic radical prostatectomy (RRP). Read More

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September 2021

Design of a multifaceted strategy based on automated text messaging in patients with recent heart failure admission.

ESC Heart Fail 2021 Sep 18. Epub 2021 Sep 18.

HCor Research Institute, R. Des. Eliseu Guilherme, 147 - Paraíso, São Paulo, 04004-030, Brazil.

Aims: To evaluate a telemonitoring strategy based on automated text messaging and telephone support after heart failure (HF) hospitalization.

Methods And Results: The MESSAGE-HF study is a prospective multicentre, randomized, nationwide trial enrolling patients from 30 clinics in all regions of Brazil. HF patients with reduced left ventricular ejection fraction (<40%) and access to mobile phones are eligible after an acute decompensated HF hospitalization. Read More

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September 2021

Surveillance of indeterminate pulmonary nodules detected with CT in a Swedish population-based study (SCAPIS): psychosocial consequences and impact on health-related quality of life-a multicentre prospective cross-sectional study.

BMJ Open 2021 Sep 17;11(9):e048721. Epub 2021 Sep 17.

Department of Medical Imaging and Physiology, Skåne University Hospital, Malmö, Sweden

Objectives: To investigate whether surveillance of pulmonary nodules detected with low-dose CT (LDCT) impacted health-related quality of life and psychosocial consequences in the Swedish population-based study, Swedish CArdioPulmonary bioImage Study (SCAPIS).

Design: A prospective cross-sectional study.

Settings And Participants: This multicentre (five sites) observational study, which included a cohort from SCAPIS, consisted of 632 participants with indeterminate pulmonary nodules detected with LDCT. Read More

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September 2021

Comparing lung ultrasound: extensive versus short in COVID-19 (CLUES): a multicentre, observational study at the emergency department.

BMJ Open 2021 09 16;11(9):e048795. Epub 2021 Sep 16.

Department of Internal Medicine, Radboudumc, Nijmegen, The Netherlands.

Background: Bedside lung ultrasound (LUS) is an affordable diagnostic tool that could contribute to identifying COVID-19 pneumonia. Different LUS protocols are currently used at the emergency department (ED) and there is a need to know their diagnostic accuracy.

Design: A multicentre, prospective, observational study, to compare the diagnostic accuracy of three commonly used LUS protocols in identifying COVID-19 pneumonia at the ED. Read More

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September 2021

Health Related Quality of Life Over Time After Revascularisation in Patients With Chronic Limb Threatening Ischaemia.

Eur J Vasc Endovasc Surg 2021 Sep 13. Epub 2021 Sep 13.

Department of Vascular Surgery, Asahikawa Medical University, Asahikawa, Japan.

Objective: Chronic limb threatening ischaemia (CLTI) decreases life expectancy and impairs health related quality of life (HR-QOL). Revascularisation is needed to relieve ischaemia and salvage limbs. Although a major goal of CLTI treatment is maintaining QOL, little information is available about changes of HR-QOL over time after revascularisation. Read More

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September 2021

Two Weeks of Low Molecular Weight Heparin for Isolated Symptomatic Distal Vein Thrombosis (TWISTER study).

Thromb Res 2021 Sep 11;207:33-39. Epub 2021 Sep 11.

Department of Clinical Haematology, Monash Medical Centre, Melbourne, Australia; The Alfred Hospital, Melbourne, Australia; Australian Centre for Blood Diseases, Melbourne, Australia.

Background: Treatment of low-risk patients with isolated symptomatic distal deep vein thrombi (IDDVT) is uncertain.

Objective: assess whether two weeks of therapeutic anticoagulation is efficacious/safe for IDDVT.

Primary Outcome: symptomatic three-month venous thromboembolism (VTE) incidence in the two-week anticoagulation group. Read More

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September 2021

Satisfaction and continuation with LNG-IUS 12: findings from the real-world kyleena satisfaction study.

Eur J Contracept Reprod Health Care 2021 Sep 16:1-11. Epub 2021 Sep 16.

ZEG - Berlin Center for Epidemiology and Health Research GmbH, Berlin, Germany.

Purpose: The Kyleena Satisfaction Study (KYSS) aimed to assess satisfaction and continuation with levonorgestrel-releasing intrauterine system (LNG-IUS) 12 (Kyleena) in routine clinical practice and to evaluate factors that influence satisfaction.

Materials And Methods: This prospective, observational, multicentre, single-arm cohort study, with 1-year follow-up, was conducted in Belgium, Canada, Germany, Mexico, Norway, Sweden, Spain and the United States from 2017 to 2018. During routine counselling, women who independently selected to use LNG-IUS 12 were invited to participate in the study. Read More

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September 2021

Biopsy for advanced hepatocellular carcinoma: results of a multicentre UK audit.

Br J Cancer 2021 Sep 15. Epub 2021 Sep 15.

Department of Oncology, Royal Free London NHS Foundation Trust, London, UK.

Background: Advanced hepatocellular carcinoma (HCC) is commonly diagnosed using non-invasive radiological criteria (NIRC) defined by the European Association for the Study of the Liver or the American Association for the Study of Liver Diseases. In 2017, The National Institute for Clinical Excellence mandated histological confirmation of disease to authorise the use of sorafenib in the UK.

Methods: This was a prospective multicentre audit in which patients suitable for sorafenib were identified at multidisciplinary meetings. Read More

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September 2021

DIAGNOSTIC ACCURACY OF FEC-PET/CT, FDG-PET/CT AND DIFFUSION-WEIGHTED MRI IN DETECTION OF NODAL METASTASES IN SURGICALLY TREATED ENDOMETRIAL AND CERVICAL CARCINOMA.

Clin Cancer Res 2021 Sep 15. Epub 2021 Sep 15.

Imperial College London.

Purpose: Pre-operative nodal staging is important for planning treatment in cervical cancer (CC) and endometrial cancer (EC) but remains challenging. We compare nodal staging accuracy of F-ethyl-choline-(FEC)-PET/CT, F-Fluoro-deoxy-glucose-(FDG)-PET/CT and diffusion-weighted-MRI (DW-MRI) with conventional morphological MRI.

Experimental Design: A prospective, multicentre observational study of diagnostic accuracy for nodal metastases was undertaken in 5 gyne-oncology centres. Read More

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September 2021

Clinical evaluation of enhanced recovery after surgery protocol for anterior cervical decompression and fusion (ACDF): study protocol for a multicentre randomised controlled trial.

BMJ Open 2021 Sep 15;11(9):e047654. Epub 2021 Sep 15.

Department of Neurosurgery, Fujian Medical University Union Hospital PingTan Branch, Fuzhou, Fujian, China.

Introduction: To improve the efficacy of anterior cervical decompression and fusion (ACDF) and reduce postoperative complications in degenerative cervical myelopathy, our team established a set of perioperative care of enhanced recovery guidelines of ACDF based on the concept of enhanced recovery after surgery. In addition, a prospective, multicentre, randomised clinical trial was designed.

Methods And Analysis: A total of 260 patients aged 18-65 years will be included. Read More

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September 2021

The association of prothrombin complex concentrates with postoperative outcomes in cardiac surgery: an observational substudy of the FIBRES randomized controlled trial.

Can J Anaesth 2021 Sep 14. Epub 2021 Sep 14.

Department of Anesthesia and Pain Management, Toronto General Hospital - University Health Network, Sinai Health System, Women's College Hospital,, University of Toronto, 200 Elizabeth Street, 3EN-464, Toronto, ON, M5G 2C4, Canada.

Purpose: The mainstay of therapy for coagulation factor deficiency in cardiac surgical patients is frozen plasma (FP); however, prothrombin complex concentrates (PCCs) may offer logistical and safety advantages. As there is limited comparative evidence, we conducted this study to explore the association of comparable PCC or FP doses with transfusion and outcomes.

Methods: This was a post hoc analysis of a multicentre randomized trial comparing fibrinogen concentrate with cryoprecipitate (FIBRES trial) in bleeding cardiac surgical patients. Read More

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September 2021

COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study.

BMJ Open 2021 09 14;11(9):e049376. Epub 2021 Sep 14.

Department of Obstetrics and Gynaecologyhe, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

Introduction: There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic. Read More

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September 2021

Comparison of NICE Guideline CG149 and the Sepsis Risk Calculator for the Management of Early-Onset Sepsis on the Postnatal Ward.

Neonatology 2021 Sep 9:1-7. Epub 2021 Sep 9.

Imperial College London, London, United Kingdom.

Introduction: The NICE guideline CG149 has increased the number of well infants receiving antibiotics for suspected early-onset sepsis (EOS). The Kaiser Permanente sepsis risk calculator (SRC) has safely and dramatically reduced investigations and antibiotics for suspected EOS in the USA. This study evaluates the current management of suspected EOS against the NICE guideline CG149 and the SRC. Read More

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September 2021

Impact of Polypharmacy on Health-Related Quality of Life in Dialysis Patients.

Am J Nephrol 2021 Sep 10:1-10. Epub 2021 Sep 10.

Department of Nephrology, Amsterdam UMC, Research Institute Amsterdam Cardiovascular Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Introduction: Dialysis patients are often prescribed a large number of medications to improve metabolic control and manage coexisting comorbidities. However, some studies suggest that a large number of medications could also detrimentally affect patients' health-related quality of life (HRQoL). Therefore, this study aims to provide insight in the association between the number of types of medications and HRQoL in dialysis patients. Read More

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September 2021

SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial.

BMJ Open 2021 Sep 13;11(9):e052494. Epub 2021 Sep 13.

Department for Health Evidence, Radboud University Medical Center, Nijmegen, Gelderland, The Netherlands.

Introduction: Lung cancer and its treatment cause a wide range of symptoms impacting the patients' health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. Read More

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September 2021

Determinants of losses in the latent tuberculosis infection cascade of care in Brazil.

BMJ Glob Health 2021 Sep;6(9)

Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, AM, Brazil

Introduction: Factors associated with losses in the latent tuberculosis infection (LTBI) cascade of care in contacts of patients with tuberculosis (TB) were investigated in a multicentre prospective cohort from highly endemic regions in Brazil.

Methods: Close contacts of 1187 patients with culture-confirmed pulmonary TB were prospectively studied between 2015 and 2019, with follow-up of 6-24 months. Data on TB screening by clinical investigation, radiographic examination and interferon-gamma release assay (IGRA) were collected. Read More

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September 2021