The Investigational Clinical Center: a clinical-supportive and patient-centered trial unit model. Ten years of experience through normal and pandemic times of a large pediatric trial center in ItalyInvestigational Clinical Center: 임상 지원 및 환자 중심 시험 단위 모델. 이탈리아의 대규모 소아 임상 센터에서 정상 및 유행성 시기에 걸친 10년의 경험Letter to the Editor Published on 2021-07-132022-09-10 Journal: Italian Journal of Pediatrics [Category] SARS, 임상, [키워드] activities affected best center children clinical Clinical management Clinical research clinical trial Clinical trial unit clinical trials clinician Complete complexity Compliance conducted COVID-19 pandemic Efficacy and safety engage enrolled evaluated Evidence-based medicine feature Good Good Clinical Practice helping ICC implementation include investigator investigators Italy legal guardian majority management Metrics off-label offer overcome pandemic parent parents Patient pediatric Pediatric clinical research pediatrics pharmacological Practice principal investigator Principal Investigators rare diseases recruitment reported Research Research staff Rome supplementary material Support Treatment Trial Trial implementation Trial management unit [DOI] 10.1186/s13052-021-01099-0 PMC 바로가기 [Article Type] Letter to the Editor
Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trialCOVID-19가 있는 중환자 중환자실 환자의 임상 상태, 사망률, 산화 스트레스 및 염증 지표에 대한 커큐민-피페인 보충제의 효과: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-07-062022-09-10 Journal: Trials [Category] SARS, 임상, [키워드] 1:1 addition Administered All participants allocation sequence ALT anticipated Anticoagulant assigned AST baseline Blinding Blood oxygen saturation C-reactive protein Capsule clinical clinical status Clinical symptoms clinical trial clinical trials CLOCK collected color conducted congenital disorders control group coronavirus COVID-19 creatinine Critically ill CRP Curcumin definitive diagnosis Diseases disorders dissemination double-blind drug Effect Efficacy element eligible patient enteral feeding erythrocyte sedimentation erythrocyte sedimentation rate ESR exclusion criteria Factors female Fever File Hepatic insufficiency hospital ICU ICU patient ICU Patients immune include inclusion criteria independent Inflammatory marker intensive care intensive care unit Intervention intervention group investigators Iran kidney function marker kidney function markers labeling LDH liver male maltodextrin marker matching placebo Medical Sciences Mortality mortality rate normalization number Nurses objective odor outcome oxidative stress oxygen Pancreatitis parameter parenteral nutrition participant Participants Patient PCR test performed physician Physicians piperine Placebo placebo group placebo-controlled Primary outcome protocol provided random randomised randomised controlled trial Randomized Randomized controlled trial Randomly receive recruited Registered registration date registration number registry renal respiratory rate Sample size sealed secondary outcome Secondary outcomes sedimentation rate sensitivity sequence Seven Sex shape status Stratification stratified block randomization study participant Study participants Study protocol supplementary material Support Tablet Taste temperature the placebo group title Trial Trial registration turmeric underlying disease underlying diseases university ventilator Version Warfarin website weight [DOI] 10.1186/s13063-021-05372-9 PMC 바로가기 [Article Type] Letter
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial비활성화된 SARS-CoV-2 백신, BBV152의 안전성 및 면역원성: 이중 맹검, 무작위, 다기관, 2상 시험 및 이중 맹검, 무작위 1상 시험의 3개월 추적 조사의 중간 결과Clinical Trial Published on 2021-07-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] Fulltext, SARS, 임상, 진단, [키워드] 1:1 95% CI Abstract addition Administered Antigen assigned baseline Bharat block blood draw cell-mediated immune response clinical trial collected defined dose double-blind Efficacy elevated elicited enrolled evaluate first dose Follow-up geometric mean GMT healthy high neutralising antibody Hindi hospital humoral inactivated India intramuscular dose investigators Local material microneutralisation test MNT multicentre neutralisation test neutralising antibody titre nine outcomes participant phase 1 trial Phase 2 study phase 2 trial Phase 3 positive Primary outcome PRNT proportion randomisation randomised Randomly reactogenicity receive Registered remained reported response Safety SARS-CoV-2 SARS-CoV-2 nucleic acid SARS-CoV-2 vaccine screened second dose second vaccination secondary outcome selected Serious Adverse Event seroconversion rate serology test significant difference significantly higher Sponsor T-cell Response Th1 phenotype the vaccine titre Toll-like receptor translation treatment group Trial Vaccine was done were assessed were excluded wild-type [DOI] 10.1016/S1473-3099(21)00070-0 PMC 바로가기 [Article Type] Clinical Trial
BCG-induced non-specific effects on heterologous infectious disease in Ugandan neonates: an investigator-blind randomised controlled trial우간다 신생아의 이종 감염성 질환에 대한 BCG- 유도 비특이적 영향 : 조사관 맹인 무작위 대조 시험Articles Published on 2021-07-012022-09-06 Journal: The Lancet. Infectious Diseases [Category] Communicable Disease, [키워드] 1:1 Abstract addition age all-cause mortality Alter analysed analyses assigned BCG BCG vaccination benefit Birth blind block size block sizes blood sample Blood samples change clinically clinician Comparisons computer-generated Concentration Consent contributed Controlled Controlled trial Cord blood discharged Effect Effects eligible enrolled Entebbe Families finding Follow-up for inclusion funding geometric geometric mean geometric mean ratios gestational age group hazard ratio healthy hepcidin Heterologous hospital IFNγ IL-10 IL-1β IL-6 IL1B IL6 immunological incidence increase in Infant Infants infections Infectious disease inhibited Innate immunity international standard investigated investigators life Luganda material medical intervention modified intention-to-treat mononuclear cell morbidity morbidity and mortality mother Neonatal neonatal period no significant difference non-specific number outcome parent parents participant Peripheral blood Peripheral blood mononuclear cells primary clinical outcome promoter promoter region PROTECT randomisation randomised randomised controlled trial Randomly receive recruited reduce reductions reductions in Registered required saturation Standard Standard dose stratified by sex TNF Transferrin translation Trial Tuberculosis Uganda vaccination Wellcome Trust were excluded with HIV withdrawn [DOI] 10.1016/S1473-3099(20)30653-8 PMC 바로가기 [Article Type] Articles
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial60세 이상의 건강한 성인을 대상으로 한 불활성화 SARS-CoV-2 백신(CoronaVac)의 안전성, 내약성 및 면역원성: 무작위, 이중 맹검, 위약 대조, 1/2상 임상 시험Randomized Controlled Trial Published on 2021-06-012022-09-11 Journal: The Lancet. Infectious Diseases [Category] MERS, SARS, 임상, 진단, 치료기술, [키워드] Adults Adverse reaction Adverse reactions age All participants Aluminium aluminium hydroxide antibody Antibody Response Antibody titre assigned baseline Beijing block Block randomisation China Chinese clinical trial CoronaVac COVID-19 COVID-19 vaccine Cutoff defined detectable development dose dose-escalation double-blind eight Endpoint enrolled groups healthy hydroxide immunogenicity inactivated injection injection site pain intervention group Intramuscular injection investigators Laboratory live SARS-CoV-2 Mild moderate morbidity morbidity and mortality Neutralising Antibodies neutralising antibody neutralising antibody titres occurred Older Older adults participant Participants Phase 1 Phase 2 phase 3 trial Placebo placebo group placebo-controlled positive primary immunogenicity Program random assignment randomised Randomly receive Registered reported research and development Safe Safety safety population SARS-CoV-2 SARS-CoV-2 vaccine Science second dose Serious Adverse Events Seroconversion seroconversion rate seronegative seropositive Seven severity technology the disease the placebo group titre Tolerability treatment allocation trial protocol vaccination Vaccine virus [DOI] 10.1016/S1473-3099(20)30987-7 PMC 바로가기 [Article Type] Randomized Controlled Trial
The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomizationUPMC OPTIMISE-C19(COVID-19에 대한 평가를 통한 단일 클론 항체의 치료 및 영향 최적화) 시험: 반응 적응형 무작위 배정이 포함된 개방형, 실용적, 비교 효과 플랫폼 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-05-252022-09-01 Journal: Trials [Category] SARS, 변종, 임상, 진단, [키워드] adaptive Administered administration aggregate authorization bamlanivimab Bayesian blinded Blinding calculated captures Casirivimab collected Comorbidities comparator composite endpoint Course COVID-19 criteria dependent on determine determined by dissemination distribution Dosing drug Effectiveness effort element eligibility criteria Emergency emergency department Emergency Departments etesevimab EUA evaluate evaluated FDA Final Follow-up food futility Government high risk hospital Hospitalization Hospitalized Identifier Imdevimab Impact include increase in inferiority infusion Intervention investigator investigators mAbs manuscript medical record Mild mild to moderate Mild to moderate COVID-19 Moderate COVID-19 monoclonal antibodies monoclonal antibody monotherapy number obese objective Open-label outcome outcome assessor outcome assessors oxygen pandemic participant Patient physician Platform trial Pragmatic pragmatic trial Primary outcome protocol provide random random allocation randomised randomised controlled trial randomization reached receive recorded recruitment routine clinical care Sample Sample size SARS-CoV-2 variant SARS-CoV-2 variants severe COVID-19 statistical statistical inference status Study protocol submission supplementary material supply sustained Symptoms System the patient the United State therapeutic Treatment treatment of COVID-19 Trial Trial registration United States US Food and Drug Administration Version Volume website [DOI] 10.1186/s13063-021-05316-3 PMC 바로가기 [Article Type] Letter
Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial입원 중인 COVID-19 환자의 회복기 혈장 사용의 안전성과 효능을 평가하기 위한 무작위 임상 시험(PERUCONPLASMA): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-05-172022-09-01 Journal: Trials [Category] SARS, 임상, 진단, 치료기술, [키워드] 1:1 ABO blood type Acute coronary syndrome administration Adverse reaction Adverse reactions aliquot Aliquots All participants allocation anaphylaxis antibody Antigen assessment Bilirubin Blinding block blocks blood gas blood gas analysis blood type C-reactive protein calculated Capacity carried case report form clinical clinical trial clinical trials Coagulation Coma completion confidence level congestive heart failure contraindication control group convalescent plasma coronary syndrome COVID-19 COVID-19 disease COVID-19 pneumonia creatinine Critical Critical disease CRP current D-dimer decrease defined detect Diagnosis dialysis disease Disseminated intravascular coagulation dissemination Donor donors drop Duration Dynamics eCRF Efficacy electronic case report form element eligible enrolled enrolment etiology evaluate evaluated events Evolution exclusion criteria expected experimental group exploratory failure following gas analysis hemodynamic instability hemorrhage hospital hospital discharge Hospitalization Hospitalized hospitalized patient hospitalized patients Hypothesis Hypoxemia ICU IIb in-hospital mortality Inclusion Infarction Inflammatory information Informed consent intensive care intensive care unit Intervention intracranial hemorrhage intravascular coagulation Invasive mechanical ventilation investigator investigators jaundice Laboratory laboratory confirmation Laboratory test Lactate lactate dehydrogenase Length less Local lymphocyte male marker Mechanical mechanical ventilation mmHg molecular Mortality multi-organ failure Myocardial infarction Neutralizing antibodies number objective occur Older open open label outcome oxygen Oxygen requirement oxygen saturation PaO participant Patient performed plasma Platelets Pneumonia power power of 80% previous diagnosis Probability protocol Public Hospital public hospitals quantification randomization Randomized Randomized controlled trial rationale receive reduce reducing reduction Registered resolution of symptom respiratory respiratory rate routine clinical practice Safe Safety Sample size SARS-COV-2 infection score Secondary objectives serious adverse reaction Serious adverse reactions serologic serum serum creatinine severe COVID-19 Severe COVID-19 pneumonia severe disease SOFA specific type standard treatment standard treatment alone statistical analysis Study protocol Stupor subject supplementary material Total total bilirubin transfusion treatment arm Trial uncontrolled vasopressors Ventilation website with COVID-19 [DOI] 10.1186/s13063-021-05189-6 PMC 바로가기 [Article Type] Letter
Associations of D-Dimer on Admission and Clinical Features of COVID-19 Patients: A Systematic Review, Meta-Analysis, and Meta-RegressionCOVID-19 환자의 입원 및 임상 특징에 대한 D-Dimer의 협회: 체계적인 검토, 메타 분석 및 메타 회귀Meta-Analysis Published on 2021-05-072022-08-31 Journal: Frontiers in Immunology [Category] SARS, 바이오마커, [키워드] (COronaVIrus Disease 2019) 95% CI age age and gender aggregate effect Alanine alanine aminotransferase ALT aspartate Aspartate aminotransferase association AST Bilirubin Biomarker Biomarkers Blood urea nitrogen Case series clinical clinical variable Comorbidity complications confounding factors coronavirus disease Coronavirus disease 2019 correlated country COVID-19 creatine creatine kinase D-dimer D-dimer level D-dimer levels dimer dynamic Dyspnea elevated fibrinogenolysis fibrinolysis finding Gender Glucose groups identify independent individual influence interquartile range investigators landscape limitation mean difference median median and interquartile range Meta-analysis meta-regression Mild Mortality nitrogen panoramic view parameter Patient performed plasma progression Publication bia publication bias raw data respiratory rate review risk stratification severity shown SpO2 Standard deviation Support systemically Systolic blood pressure therapy thrombolytic therapy urea variable [DOI] 10.3389/fimmu.2021.691249 PMC 바로가기 [Article Type] Meta-Analysis
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial비활성화된 SARS-CoV-2 백신 BBV152의 안전성 및 면역원성: 이중 맹검, 무작위, 1상 시험Clinical Trial Published on 2021-05-012022-09-11 Journal: The Lancet. Infectious Diseases [Category] Fulltext, SARS, 임상, 진단, 치료기술, [키워드] 95% CI Administered adverse event Adverse reactions alum assigned baseline Bharat block Block randomisation CD4 CD8 Cell-mediated responses control group control vaccine COVID-19 doses double-blind Effect Efficacy eligible ELISPOT enrolled evaluated event fatigue Fever first dose groups headache healthy hospital immune responses immunogenicity inactivated India individual injection site pain intramuscular dose investigator investigators Local Mild mitigate moderate multicentre nausea neutralisation nine nucleic acid outcome participant Participants Phase 1 phase 1 trial Phase 2 platform Pneumonitis positive Primary outcomes randomisation randomised Randomly receive Registered reported response Safety SARS-CoV-2 nucleic acid SARS-CoV-2 vaccine screened secondary secondary outcome selected Serious Adverse Event Serious Adverse Events Seroconversion seroconversion rates serology test serology tests Seven staining study duration subset systemic adverse reaction systemic adverse reactions systemic reactogenicity T-cell Response T-cell responses the vaccine tolerable Toll-like receptor treatment group Trial trials vaccination Vaccine Viral vomiting was done were excluded wild-type virus [DOI] 10.1016/S1473-3099(20)30942-7 PMC 바로가기 [Article Type] Clinical Trial
The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial이론 기반 메시지가 COVID-19 백신 접종 의도에 미치는 영향: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-04-292022-09-10 Journal: Trials [Category] MERS, 임상, [키워드] 1:1 allocation approach automatically blinded Blinding comparator Contact contact with COVID-19 COVID-19 illness COVID-19 vaccination COVID-19 vaccine creating dissemination element ethnic group exposure to Follow-up Gender hypothesised illness beliefs Image individual individually randomised information initiate Intention Intervention investigator investigators messaging minute Necessity-Concerns Framework number objective online survey software outcome oversampling pandemic participant Participants performed post-intervention proportion Prospective protocol randomised randomised controlled trial receive reported Sample size secondary Secondary outcomes Side effect Side effects status Study protocol supplementary material treatment beliefs Trial Trial registration two group two groups Two-arm uptake vaccination vaccination against COVID-19 vaccination intention Vaccine vaccine for COVID-19 Vaccine hesitancy variable website [DOI] 10.1186/s13063-021-05277-7 PMC 바로가기 [Article Type] Letter