Psychiatric genomics research during the COVID-19 pandemic: A survey of Psychiatric Genomics Consortium researchers코로나19 팬데믹 기간 동안의 정신의학 유전체 연구: 정신의학 유전체학 컨소시엄 연구원을 대상으로 한 설문조사Article Published on 2021-01-012022-09-11 Journal: American journal of medical genetics. Part B, Neur [Category] 유전자 메커니즘, [키워드] academic medicine concern conducted COVID-19 COVID-19 pandemic faculty female funding genders Genomics individual investigator investigators organization organizations pandemic PGC progression promotion promotion. provided Quantitative reported representing Research researcher researchers responses Result trainee women [DOI] 10.1002/ajmg.b.32838 PMC 바로가기 [Article Type] Article
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial비활성화된 SARS-CoV-2 백신 BBIBP-CorV의 안전성 및 면역원성: 무작위, 이중 맹검, 위약 대조, 1/2상 시험Clinical Trial Published on 2021-01-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] Fulltext, SARS, 임상, 진단, [키워드] 95% CI accelerated acute respiratory syndrome Adverse reaction age antibody assigned BBIBP-CorV Beijing Block randomisation center China city Cohort concealed Control coronavirus COVID-19 pandemic creation District dose double-blind drug effort eight enrolled Fever geometric mean titre greater group Group allocation groups healthy humans Humoral response IgM/IgG inactivated Infectious diseases investigators Major Mild moderate neutralising antibody response neutralising antibody titre New Older outcome assessors participant Participants Placebo placebo-controlled plan post vaccination prevention Primary outcome Program randomised Randomly receive recipient recipients Registered reported Safe Safety SARS-CoV-2 SARS-CoV-2 vaccine Science secondary outcome separated Serious Adverse Event severity Shangqiu significantly stratified technology tested the placebo group the vaccine Tolerability Trial Vaccine vaccine candidate vaccine candidates [DOI] 10.1016/S1473-3099(20)30831-8 PMC 바로가기 [Article Type] Clinical Trial
Advantages of visualisations to evaluate and communicate adverse event information in randomised controlled trials무작위 대조 시험에서 이상 반응 정보를 평가하고 전달하기 위한 시각화의 장점Research Published on 2020-12-222022-09-10 Journal: Trials [Category] 임상, 치료제, [키워드] adverse event adverse events Adverse reactions AEs Analysis article asymmetry collected communication comparison complex construction Controlled trial controlled trials COVID-19 Data analysis effective evaluate event extreme Frequency GDNF Graphics Guidance harms implementation in some information investigator investigators lack less offer outcome Parkinson disease Parkinson’s disease Placebo-controlled trials point estimate point estimates profile Prominent provided randomised controlled trial Randomised controlled trials RCTs Remdesivir Reporting risk shown Stata statistical supplementary material Support treatment effect treatment effects Trial trials Visual Visualisation volcano plot Volume [DOI] 10.1186/s13063-020-04903-0 PMC 바로가기 [Article Type] Research
The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial코로나바이러스(COVID-19) 환자의 임상 증상에 대한 프로폴리스 보충제의 효과: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Randomized Controlled Trial Published on 2020-12-032022-08-13 Journal: Trials [Category] MERS, SARS, 임상, [키워드] 1:1 age All participants anticipated Arm baseline Blinding block size calculated categories Cellulose changes in clinical clinical symptom Clinical symptoms Clinicians color concealed control group coronavirus coronavirus disease COVID-19 Date dissemination double-blind element eligible hospital Intervention intervention group investigator investigators Iran labelling microcrystalline microcrystalline cellulose name number objective odor outcome Parallel Arm participant Participants Patient patients PCR test performed pharmaceutical phase Placebo placebo-controlled clinical trial Propolis protocol Protocol study provided randomised controlled trial randomization randomization list randomization sequence Randomized Randomly receive recruited Registered registration number Reyhan Sample size sealed sensitivity sequence severity Sex shape stratified Study protocol supplementary material Tablet Taste total sample size Trial Trial registration Version Warfarin website weight [DOI] 10.1186/s13063-020-04934-7 PMC 바로가기 [Article Type] Randomized Controlled Trial
Exclusion of enrolled participants in randomised controlled trials: what to do with ineligible participants?Randomized Controlled Trial Published on 2020-12-022022-10-04 Journal: BMJ Open [Category] Fulltext, MERS, SARS, 임상, [키워드] Analysis assumed board Clinical practice creating criteria education & training (see medical education & training) Effect Efficacy eligibility criteria enrolled exclusion include Including Inclusion ineligible intention-to-treat Interpretation intervention effect investigator investigators Lung disease Lung function Measurement error monitoring objective opposite paediatric thoracic medicine participant Participants primary analysis randomisation randomised randomised controlled randomised controlled trial reached reported risk Safety Sample size sensitivity analysis Statistical analysis plan Statistical power statistics & research methods steering committee subsequent Treatment Trial Variation with HIV Zimbabwe [DOI] 10.1136/bmjopen-2020-039546 PMC 바로가기 [Article Type] Randomized Controlled Trial
Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trialCOVID-19(IVERCOR-COVID19) 환자의 입원을 방지하기 위한 Ivermectin: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약Randomized Controlled Trial Published on 2020-11-242022-08-13 Journal: Trials [Category] SARS, 임상, 치료기술, [키워드] 1:1 acute infectious disease addition adherence administration Admission adverse event adverse events age allergy analyzed Anthropometric data antiviral drug antiviral drugs Arm ARMS assessment barrier basal blinded Breastfeeding breastfeeding women Cardiology Care care providers carried cause Chain Reaction childbearing age Chloroquine cirrhosis component components Concomitant Concomitant medication Confirmed connection contraceptive method contraceptives Control control group control groups coordination Corriente COVID-19 COVID-19 patient population criteria current Day death demographic demographic data Diagnosis diagnosis of COVID-19 dialysis discharged dissemination dose double-blind drug Efficacy Efficacy and safety elapsed element EOS Equal example exclusion criteria Final final visit first dose Follow-up greater heart rate Hospitalization hospitalizations Hydroxychloroquine incidence include Inclusion inclusion criteria inclusion/exclusion criteria Informed consent Intervention Invasive mechanical ventilation investigator investigators Ivermectin Ivermectin safety Laboratory less liver Liver cirrhosis Liver disease mal-absorptive syndrome medical history medication menstrual menstrual cycles Mortality negative Negative PCR number objective outcome outcome assessor outcome assessors over oxygen oxygen saturation parallel group participant Participants Participation Patient patients with COVID-19 PCR PCR swab Placebo placebo-controlled study polymerase chain polymerase chain reaction Polymerase chain reaction test postmenopausal pregnant Presence Prevent Primary outcome protocol Public public health randomization Randomized Randomized controlled trial randomly permuted blocks receive recommendation recorded recruitment reducing renal replacement therapy replacement therapy reproductive required Research Sample size SARS-CoV2 secondary severe liver disease single-center standard treatment standard treatment alone Study protocol supplementary material surgical Swab table Tablet temperature the patient Total Treatment Trial Trial registration use of hydroxychloroquine Version Viral viral pathology Vital vital signs vital status web system website weight woman women [DOI] 10.1186/s13063-020-04813-1 PMC 바로가기 [Article Type] Randomized Controlled Trial
Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019코로나바이러스 2019에 렘데시비르를 사용한 간 장애Multicenter Study Published on 2020-11-012022-09-11 Journal: Clinical gastroenterology and hepatology : the off [Category] Coronavirus, SARS, 비임상, [키워드] Adverse drug reaction adverse event adverse events Aminotransferase antiviral activity available data Bilirubin breath broad spectrum Cell culture cell cultures clinical development clinical trials Cohort studies cohort study compassionate-use coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patients disorder double-blind drug drug reaction Drug-induced liver injury elevated EMA European Medicines Agency FDA food healthy volunteer healthy volunteers hepatic hepatic enzyme hepatic enzymes hepatotoxicity hospital human coronavirus increase Infection Intravenous remdesivir investigator investigators Liver injury mouse model Mouse models nucleotide Patient patients hospitalized patients with COVID-19 Placebo placebo recipient placebo recipients placebo-controlled clinical trial proportion raised Randomized recipient Remdesivir reported respiratory safety profile Severe acute respiratory syndrome Severe Acute Respiratory Syndrome-associated Coronavirus 2 severe coronavirus disease severe COVID-19 treated Treatment [DOI] 10.1016/j.cgh.2020.07.050 PMC 바로가기 [Article Type] Multicenter Study
Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic코로나19 팬데믹 상황에서 임상시험에 대한 통계적 평가Article Published on 2020-11-012022-09-11 Journal: Therapeutic innovation & regulatory science [Category] 임상, [키워드] Accuracy assist can be used clinical clinical evaluation Clinical practice Clinical studies clinical study clinical trial clinical trials Compliance COVID-19 COVID-19 pandemic determine deviation dose eligibility criteria FDA Good Clinical Practice Guidance include investigator investigators IRBs not limited patient population protocol Regulatory reliability reproducibility Reproducibility probability risk shift Shift in patient population. statistical Treatment Trial trial participants [DOI] 10.1007/s43441-020-00182-8 PMC 바로가기 [Article Type] Article
Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial)증상이 있는 SARS-CoV-2 감염(COVID-19)이 있는 고령자의 가정 치료: 여러 가지 실험적 치료의 효능과 내약성을 평가하기 위한 MAMS(Multi-Arm Multi-Stage) 무작위 시험에 대한 연구 프로토콜의 구조화된 요약 65세 이상 외래 환자의 입원 또는 사망 위험 감소(COVERAGE 시험)Letter Published on 2020-10-132022-08-13 Journal: Trials [Category] MERS, SARS, 임상, [키워드] 6-mercaptopurine Abnormalities ACEi added age amodiaquine Analysis antrafenine approved ARB ARBs Arm azathioprine Blinding Bordeaux Caregivers Chloroquine chronic hepatitis Chronic kidney disease citalopram clinical Colitis Combination comparator complex conducted Control control arm COVID-19 COVID-19 pandemic criteria CYP3A4 cytochrome P450 Dasatinib death Dementia dialysis dissemination Domperidone drug Duchy Efficacy element enrolled enrolment Enterocolitis escitalopram EudraCT Evidence exclusion criteria experimental arm experimental drug Experimental drugs Favipiravir feasibility Final final analysis first symptom first symptoms floctafenine France French futility galactose GFR glafenine Glucose Glucose-6-phosphate glucose-6-phosphate dehydrogenase glucose-6-phosphate dehydrogenase deficiency Grand duchy halofantrine Health Insurance heart rate hepatic Hepatic porphyria home hospital hospitalisation Hydroxychloroquine hydroxyzine hypersensitivity Hyperuricemia Ileus Imatinib immunological incidence Inclusion increase in inducer inhibitor Interim analyses interim analysis intervals investigator investigators Isoenzyme Kidney disease Lactase Lactose liver failure Long Long QT syndrome Luxembourg malabsorption mefloquine mercaptopurine metabolism multi multi-arm nasopharyngeal Nasopharyngeal swab New Nilotinib not blinded number nursing home nursing homes objective Older Open-label open-label trial other treatment other treatments outcome Outpatient P450 Paris participant Patient performed phase Piperaquine Positive test Prevent primary care Primary outcome proportion protocol pyrazinamide QTc interval randomisation randomised Randomized Randomly receive recruited Region Registered regulatory authority repaglinide replaced REPLACED BY reported Repurposed drug residence Safety Monitoring Board Sample size SARS-CoV-2 SARS-COV-2 infection scale Stage Standard statistician statisticians status stratified Study protocol submitted symptomatic SARS-CoV-2 infection Tablet telmisartan tested theophylline Toxicity Trace element trace elements treated Treatment treatment arm Trial Trial registration Version virus Virus Disease Vitamin vitamins Warfarin [DOI] 10.1186/s13063-020-04619-1 PMC 바로가기 [Article Type] Letter
Safety and immunogenicity of two heterologous HIV vaccine regimens in healthy, HIV-uninfected adults (TRAVERSE): a randomised, parallel-group, placebo-controlled, double-blind, phase 1/2a studyHIV에 감염되지 않은 건강한 성인을 대상으로 한 두 가지 이종 HIV 백신 요법의 안전성 및 면역원성(TRAVERSE): 무작위 배정, 병렬 그룹, 위약 대조, 이중 맹검, 1/2a상 연구Articles Published on 2020-09-302022-09-06 Journal: The Lancet. HIV [Category] Communicable Disease, [키워드] 95% CI Ad26 Adenovirus Administered advancement adverse event adverse events aligned All participant All participants Analysis Antigen antigens applied assigned binding antibodies binding antibody blood sample breadth CD4+ T-cell clade collected computer-generated Defense Deltoid muscle Department diagnosed dose double-blind Efficacy elicit Eligible participants ELISpot responses enrolled finding first vaccination foundation funding group groups healthy Heterologous HIV HIV infection HIV vaccine HIV-1 infection HIV-uninfected IFNγ ELISPOT response IFNγ ELISPOT responses IgG immune response immune responses Immunity immunogenicity injection Intramuscular injection investigator investigators Jackson janssen Laboratory Local magnitude median medical history Medicine Melinda Gate Melinda Gates Military Medicine mononuclear cell mononuclear cells opinion Other parallel-group participant PBMC PBMCs per protocol per-protocol Peripheral blood Peripheral blood mononuclear cells Physical examination Placebo placebo group placebo-controlled placebos prevention randomisation randomised Randomly randomly permuted block randomly permuted blocks regimen regimens Registered repeated risk Safe Safety second vaccination Sponsor stratified subgroups systemic reactogenicity T-cell Response tested tetravalent the placebo group titre titres Tolerability treatment allocation Trial trivalent USA vaccination vaccination schedule Vaccinations Vaccine vaccine group vectored vaccine vital sign was done with HIV [DOI] 10.1016/S2352-3018(20)30229-0 PMC 바로가기 [Article Type] Articles