Chasing LDL cholesterol to the bottom — PCSK9 in perspective Reviews Published on 2022-06-152022-10-05 Journal: The Pan African Medical Journal [Category] 유전자 메커니즘, [키워드] alleviate Atherosclerosis atherosclerotic cardiovascular disease cardiovascular risk combating Concentration contribute events Health Improved Intervention investigators LDL LDL cholesterol LDL-C Low-density lipoprotein Measures notable outcome PCSK9 Perspective Prevent recent reflect therapeutic therapy [DOI] 10.1038/s44161-022-00085-x [Article Type] Reviews
Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial6~17세 어린이 대상 ChAdOx1 nCoV-19(AZD1222) 백신의 안전성 및 면역원성: 2상 단일 맹검, 무작위, 대조 시험인 COV006의 예비 보고서Clinical Trial Published on 2022-06-112022-09-11 Journal: Lancet (London, England) [Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료법, [키워드] 95% CI administration Adults adverse event adverse events age All participants anti-SARS-CoV-2 IgG antibody Antibody titre antibody titres arbitrary unit assigned AstraZeneca AZD1222 baseline capsular Cellular responses ChAdOx1 ChAdOx1 nCoV-19 children chronic respiratory conditions Concentration Controlled trial COVID-19 COVID-19 vaccine COVID-19 vaccines Cutoff Department dose doses Efficacy enrolled Fever first dose first vaccination four group four groups geometric geometric mean geometric mean ratios Geometric means group half-maximal inhibitory concentration Humoral response humoral responses immune response immune responses immunogenic immunogenicity in some intramuscular dose introduced investigators ISRCTN Laboratory laboratory-confirmed Laboratory-confirmed COVID-19 Local nucleocapsid protein Pain and tenderness participant Participants peaked Phase 2 phase 3 study preliminary report Primary outcome prime and boost raised randomised Randomly receive receiving recruitment Registered remained reported resolved respiratory response Safety safety population SARS-CoV-2 second dose second vaccination secondary outcome Serious Adverse Event Serious Adverse Events seronegative seronegative participant seronegative participants seropositive serostatus single-blind stratified study drug study groups tenderness Tolerability treatment allocation Trial vaccination Vaccine Viral viral particle were recorded [DOI] 10.1016/S0140-6736(22)00770-X PMC 바로가기 [Article Type] Clinical Trial
Efficacy and safety of intramuscular administration of tixagevimab–cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trialClinical Trial Published on 2022-06-072022-10-05 Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 임상, 진단, 치료법, 치료제, [키워드] 1:1 95% CI administration Adverse age Antigen assigned AstraZeneca block sizes blocked clinical clinical evaluation clinically collected conducted Course COVID-19 COVID-19 vaccination death dose double-blind Efficacy enrolled enrolment Europe evaluate event Fever finding for inclusion funding individual intramuscular intramuscular injections investigators involved Japan laboratory-confirmed SARS-CoV-2 infection Latin America less Mild moderate Moderate COVID-19 monoclonal antibody combination non-hospitalised occurred Older outcomes participant Phase 3 Placebo placebo-controlled study placebo-controlled trial prevent disease progression primary endpoint progression provided randomisation randomised Randomly receive Registered required respiratory tract risk reduction RT-PCR scale severe COVID-19 severity specimen Sponsor statistically stratified study drug Symptom symptom onset the disease the placebo group treating Treatment treatment group USA WHO [DOI] 10.1016/S2213-2600(22)00180-1 [Article Type] Clinical Trial
Long-term cardio-vascular risk assessment in chronic kidney disease and kidney transplanted patients following SARS-COV-2 disease: protocol for multi-center observational match controlled trial만성 신장 질환 및 SARS-COV-2 질환에 따른 신장 이식 환자의 장기 심혈관 위험 평가: 다기관 관찰 일치 대조 시험 프로토콜Article Published on 2022-05-062022-09-11 Journal: BMC Nephrology [Category] COVID19(2023년), SARS, 임상, [키워드] Acute kidney injury acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 affecting angiotensin Angiotensin-converting enzyme association binding Biomarkers blood vessels Cardiac complications Cardio-vascular risk cardiovascular cardiovascular disease caused chronic Chronic kidney disease CKD clinical evaluation control group Controlled trial coronavirus coronavirus disease COVID-19 COVID-19 disease CVD database de novo death determine dialysis disease echocardiographic parameters Endothelial cell endothelial cells Endothelial dysfunction enrolment epithelial cells expected expressed focus heart higher risk implication incidence investigator investigators kidney Kidney disease kidney transplant lung mechanism multi-organ failure outcomes pandemic Patient patients pericyte pericytes podocyte produced protocol proximal pulse Pulse wave pulse wave velocity Registered renal risk risk factor SARS-CoV-2 SARS-COV-2 infection Sepsis severe acute respiratory syndrome Coronavirus severe disease Shock the disease therapeutic options Trial worse prognosis [DOI] 10.1186/s12882-022-02809-4 PMC 바로가기 [Article Type] Article
Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study건강한 성인에서 AS03 보조제 SARS-CoV-2 재조합 단백질 백신(CoV2 preS dTM)의 안전성 및 면역원성: 2상, 무작위, 용량 찾기, 다기관 연구의 중간 결과Clinical Trial Published on 2022-05-012022-09-11 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] 95% CI abstinence adjuvants Adults adverse event adverse events Adverse reaction Adverse reactions age All participant All participants antibody Antibody titre Antigen AS03 assessments assigned authority baseline booster vaccination candidate vaccine Chemotherapy childbearing potential clinical development Clinical research clinical trial Cohort Contraception COVID-19 vaccine D614G variant development dose effective Endpoint enrolled evaluated expected fixed Frequency geometric mean geometric mean titre GMT GMT ratio GMTs groups healthy High dose High-dose high-dose group Immunocompromised immunogenicity increase in increased risk injection injection site Injections intensity interim results investigator investigators involved Laboratory lactating low dose low-dose medical condition Medical conditions medium medium dose Mild mild to moderate moderate multicentre Neutralising Antibodies neutralising antibody neutralising antibody titre neutralising antibody titres occurred Older Older adults Organ transplant outcome outcome assessor outcome assessors parallel-group participant Participants Phase 2 Phase 3 positive prefusion pregnant primary immunogenicity progression proportion Protein protocol provided pseudovirus neutralisation assay randomised Randomly reactogenicity receive Registered reported Research research and development responses robust Safety safety analysis safety endpoints safety profile Sanofi Pasteur SARS-CoV-2 second dose second vaccination selected Serious Adverse Event Serious Adverse Events serodiagnostic Seven severe COVID-19 Stratification study period supported systemic test result titre titres Treatment treatment group treatment groups Trial USA vaccination Vaccine was done were excluded were measured yes or no [DOI] 10.1016/S1473-3099(21)00764-7 PMC 바로가기 [Article Type] Clinical Trial
Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in IndiaClinical Trial Published on 2022-04-022022-10-05 Journal: Lancet (London, England) [Category] COVID19(2023년), SARS, 임상, [키워드] 1:1 95% CI Administered adverse event Analysis assessment assigned baseline Biotechnology clinical clinical trial comorbid conditions conducted COVID-19 criteria Cutoff death Department DNA dose double-blind Efficacy efficacy analysis eligible enrolled Government of India Gujarat identify immunogenic India individual injection interim analysis investigators multicentre Occurrence Older outcome assessor participant per-protocol population Phase 3 phase 3 trial Placebo placebo group placebo-controlled placebo-controlled study Primary outcome randomisation randomised Randomly receive Registered registry reported Safe safety population SARS-CoV-2 SARS-CoV-2 vaccine screened symptomatic the placebo group Tolerability Treatment treatment group Trial Vaccine was done was used [DOI] 10.1016/S0140-6736(22)00151-9 PMC 바로가기 [Article Type] Clinical Trial
Research monitoring practices in critical care research: a survey of current state and attitudes중환자 연구에서의 연구 모니터링 관행: 현황 및 태도 조사Article Published on 2022-03-212022-09-11 Journal: BMC Medical Research Methodology [Category] 임상, [키워드] adopted aims approach assessment clinical Clinical research clinical trial coronavirus disease COVID-19 Critical care develop ENhance Gain Good Good Clinical Practice Guidance hospitals impacted indicated International investigators involved lack methodology monitoring New ordination performed Practice principal Principal Investigators reducing reported Research risk Risk assessment Risk-based monitoring. statistical statistician statisticians Support was used [DOI] 10.1186/s12874-022-01551-7 PMC 바로가기 [Article Type] Article
Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial중국 성인을 대상으로 한 SARS-CoV-2 ARCoV mRNA 백신의 안전성 및 면역원성: 무작위 배정, 이중 맹검, 위약 대조, 1상 시험Clinical Trial Published on 2022-03-012022-09-11 Journal: The Lancet. Microbe [Category] MERS, SARS, 임상, 진단, 치료기술, [키워드] abnormal change abnormal changes Academy administration adverse event adverse events Adverse reaction Adverse reactions All participant All participants analyses Analysis Anti-RBD IgG anti-SARS-CoV-2 Antibody titre assigned baseline block Block randomisation caused cellular immune responses China Chinese clinical testing conducted convalescent patient Convalescent patients COVID-19 pandemic development domain dose dose-escalation doses double-blind effective vaccine Effective vaccines eligible participant ELISA ELISPOT ENCODE enrolled enzyme enzyme-linked immunospot expected exploratory Fever first vaccination FIVE foundation grade 3 group groups highest hospital humoral humoral immune responses Humoral response humoral responses IFN-γ IL-2 immune immune response immune responses immunogenicity incidence individual Intramuscular injection investigators Laboratory laboratory analyses Laboratory test Laboratory tests live SARS-CoV-2 lowest majority Medical Science Medical Sciences Mild moderate mRNA vaccine natural neutralisation assays Neutralising Antibodies neutralising antibody observation outcome participant Participants peaked Phase 1 phase 1 trial Placebo placebo group placebo-controlled Primary outcome pseudovirus randomised Randomly RBD RBD IgG RBD-specific IgG receive Registered reported research and development resolved Safe Safety safety analyses safety profile SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2-specific T-cell response SARS-CoV-2-specific T-cell responses Science screened second dose second vaccination secondary outcome Serious Adverse Event Serious Adverse Events Seven significantly Specific Specific T-cell response Spike protein Support systemic adverse event T-cell Response T-cell responses the placebo group the SARS-CoV-2 titre titres Tolerability treatment allocation Trial vaccination Vaccine vaccine dose vaccine doses were assessed were given with COVID-19 Zhejiang [DOI] 10.1016/S2666-5247(21)00280-9 PMC 바로가기 [Article Type] Clinical Trial
The collaborative outcomes study on health and functioning during infection times in adults (COH-FIT-Adults): Design and methods of an international online survey targeting physical and mental health effects of the COVID-19 pandemic성인의 감염 시간 동안 건강 및 기능에 대한 공동 결과 연구(COH-FIT-Adults): COVID-19 대유행의 신체적, 정신적 건강 영향을 대상으로 하는 국제 온라인 설문 조사의 설계 및 방법Article Published on 2022-02-152022-09-11 Journal: Journal of affective disorders [Category] COVID19(2023년), SARS, 치료기술, 치료제, [키워드] adolescents Adults among others Anxiety associations children COH-FIT collected COVID COVID-19 COVID-19 pandemic cross-sectional survey Depression disorders Effect functioning group Health Health care health care workers identify IMPROVE include infected with COVID-19 Infection International Intervention investigator investigators Mental Mental Disorders mental health outcome pandemic Pandemics Participants participated physical Physical health post-traumatic preponderance psychiatry quarantine representative Resilience Result risk secondary secondary outcome Secondary outcomes seeking starting Substance use survey target time Treatment Violence Well-being [DOI] 10.1016/j.jad.2021.07.048 PMC 바로가기 [Article Type] Article
Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trialCovid-19 (회복)로 병원에 입원 한 환자의 Casirivimab 및 Imdevimab : 무작위, 통제, 오픈 라벨, 플랫폼 시험Randomized Controlled Trial Published on 2022-02-122022-08-13 Journal: Lancet (London, England) [Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료기술, 치료제, [키워드] (Medical Research Council 1:1 28-day mortality 95% CI Administered Adverse reaction Adverse reactions All participants all randomly assigned patients all-cause mortality Analysis antibody assigned baseline baseline antibody status bleeding Cardiac arrhythmia Casirivimab cause-specific mortality clinically suspected Combination death detectable died dose Efficacy Efficacy and safety eligible Eligible participants enrolled evaluate finding funding hospital host cells humoral immune response Imdevimab Innovation Intention intention to treat intravenous infusion investigator investigators ISRCTN laboratory-confirmed SARS-CoV-2 infection Local major bleeding events Medical Research Council monoclonal antibody monoclonal antibody combination Mortality mounted non-competing monoclonal antibodies non-competing monoclonal antibody Open-label outcome p value participant Patient Platform trial Primary outcome randomisation randomised randomised, controlled, open-label platform trial Randomly randomly assigned patient rate ratio Receptor binding domain recovery reduced Registered reported Safety SARS-COV-2 infection SARS-CoV-2 spike glycoprotein SARS-CoV-2 vaccine Serious adverse reactions seronegative seronegative patient seronegative patients seropositive seropositive and seronegative patients Seven significantly single intravenous infusion spike glycoprotein Standard of care the SARS-CoV-2 thrombosis Treatment Trial UK hospital usual care usual care alone Viral viral entry with COVID-19 [DOI] 10.1016/S0140-6736(22)00163-5 PMC 바로가기 [Article Type] Randomized Controlled Trial