Research Ethics – Page 6 – Communicable Diseases Research

Implementation of serological and molecular tools to inform COVID-19 patient management: protocol for the GENCOV prospective cohort study

COVID-19 환자 관리를 알리는 혈청학적 및 분자적 도구의 구현: GENCOV 전향적 코호트 연구를 위한 프로토콜

Article

Published on 2021-09-302022-09-11
Journal: BMJ Open [Category] SARS, 변종, 진단,

Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2

SARS-COV-2에 대한 강력한 항 바이러스 활성을 갖는 리보 뉴 클레오 사이드 유사체 인 EIDD-2801/MK-4482 (Molnupiravir)의 최초 인간 임상 시험의 가속화 된 인간 임상 시험.

Randomized Controlled Trial

Published on 2021-08-232022-08-13
Journal: Trials [Category] MERS, 임상, 치료제,

[키워드] accelerated Accelerated start-up acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 administration Antiviral antiviral activity antiviral agent approval causative agent Clinical data clinical trial Cohort cohorts collaboration Complete completion contract research organization coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 CRO daily dose described dose Dose escalation Dosing double-blind drug eight Escalation ethics committee fasted or fed state FDA FIH FIH study followed by food food-effect global pandemic healthy volunteer healthy volunteers initial initiated MAD MAD cohort MAD cohorts Medicine Medicines Medicines and Healthcare products Regulatory Agency MHRA molnupiravir multiple ascending dose Painter pharmacokinetic Phase 2 phase 2 dosing Phase 2 study phase 2/3 Phase I Placebo profile protocol Randomized REC receive receiving Regulatory Regulatory Authorities regulatory authority Research Ethics Research Ethics Committee respiratory Ribonucleoside analog SAD cohort Safe SARS-CoV-2 sequence Seven severe acute respiratory syndrome Coronavirus single ascending dose Sponsor subject submission supported timelines Tolerability United Kingdom US Food and Drug Administration were dosed working
[DOI] 10.1186/s13063-021-05538-5 PMC 바로가기 [Article Type] Randomized Controlled Trial

Early warning and rapid public health response to prevent COVID-19 outbreaks in long-term care facilities (LTCF) by monitoring SARS-CoV-2 RNA in LTCF site-specific sewage samples and assessment of antibodies response in this population: prospective study protocol

LTCF 현장별 하수 샘플에서 SARS-CoV-2 RNA를 모니터링하고 이 인구집단에서 항체 반응을 평가하여 장기 요양 시설(LTCF)에서 COVID-19 발생을 예방하기 위한 조기 경보 및 신속한 공중 보건 대응: 전향적 연구 프로토콜

Article

Published on 2021-08-202022-09-11
Journal: BMJ Open [Category] MERS, SARS, 변종, 진단, 치료기술,

[키워드] 24 hour 24 hours Abstract Analysis antibody Antibody assays Antibody Response Antibody testing approval Asymptomatic COVID-19 benefit board Care correlation COVID-19 COVID-19 case COVID-19 outbreak COVID-19 pandemic COVID-19 vaccination COVID-19 vaccines discomfort dissemination Early detection effective Efficacy Epidemiology Ethics followed by force Health health economics high morbidity and mortality immune response Immunity immunology implementation include Infection infection control information Laboratory Long-term care Longevity manuscript measure molecular MONITOR morbidity and mortality Neutralising Antibodies neutralising antibody notification outbreak Outbreak investigation pandemic participant Participants peer-reviewed performed presymptomatic Prevent Prospective Study protocol Public public health quantification Research Ethics risk robustness SARS-CoV-2 SARS-CoV-2 antibodies SARS-CoV-2 antibody SARS-CoV-2 RNA Scientific community Study participants Support Task Force the antibody response Transmission university Vaccine variant was obtained
[DOI] 10.1136/bmjopen-2021-052282 PMC 바로가기 [Article Type] Article

Payment of COVID-19 challenge trials: underpayment is a bigger worry than overpayment

Comment

Published on 2021-08-012023-07-05
Journal: Journal of medical ethics [Category] SARS,

[키워드] Research Ethics
[DOI] 10.1136/medethics-2020-106901 PMC 바로가기 [Article Type] Comment

Protocol for DexEnceph: a randomised controlled trial of dexamethasone therapy in adults with herpes simplex virus encephalitis

Dexenceph의 프로토콜 : 단순 포진 바이러스 뇌염을 가진 성인의 덱사메타손 요법의 무작위 대조 시험

Neurology

Published on 2021-07-212022-09-10
Journal: BMJ Open [Category] Fulltext, SARS, 임상, 치료기술, 치료제,

[키워드] 1:1 aciclovir Antiviral treatment approval ARMS Brain cerebrospinal fluid Clinical outcome clinical outcomes completion Consequences control arm Corticosteroid corticosteroid therapy determine Dexamethasone disease dissemination DNA Encephalitis Ethical approval Ethics ethics committee EudraCT Evidence facilitate functional herpes simplex herpes simplex virus Immunosuppression IMPROVE include index Inflammation memory multicentre neurological injury NEUROLOGY occur Open-label outcome outcomes Patient Pragmatic Primary outcome problem randomisation randomised randomised controlled trial rare disease receive recruited recruitment reducing registration numbers Research Ethics scale secondary Secondary outcomes standard treatment standard treatment alone survivor target temporal lobe therapy Trial verbal Viral viral replication Virology virus virus encephalitis worsening
[DOI] 10.1136/bmjopen-2020-041808 PMC 바로가기 [Article Type] Neurology

Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees

Research Article

Published on 2021-07-192022-10-28
Journal: BMC Medical Ethics [Category] COVID-19, Fulltext, SARS,

Flash glucose monitoring with the FreeStyle Libre 2 compared with self-monitoring of blood glucose in suboptimally controlled type 1 diabetes: the FLASH-UK randomised controlled trial protocol

프리 스타일 Libre 2를 이용한 플래시 포도당 모니터링은 아형 제 1 형 당뇨병에서 혈당의 자체 모니터링과 비교하여 : Flash-UK 무작위 대조 시험 프로토콜

Diabetes and Endocrinology

Published on 2021-07-142022-09-10
Journal: BMJ Open [Category] Fulltext, SARS, 임상,

[키워드] acceptability adjusted adverse event adverse events age All participants analysed Analysis approved baseline baseline value blinded blood glucose clinical trials collected conducted Control covariance COVID-19 pandemic diabete diabetes diabetes & endocrinology doses Efficacy analyses efficacy analysis eight Eligible participants Ethics ethics committee Factor Flash general diabetes Glucose glycaemic control Haemoglobin health economics Health Service include Informed consent insulin intention-to-treat principle Intervention Measures Metrics multicentre National Health Service Open-label Optimising outcome participant Participants performed Perspective potential benefit potential benefits primary care Primary outcome Prognostic factors protocol Psychosocial randomised randomised controlled trial Randomised controlled trials recruit registration number Research Ethics resource secondary Secondary outcomes self-monitoring Standard of care T1D Type 1 diabetes West
[DOI] 10.1136/bmjopen-2021-050713 PMC 바로가기 [Article Type] Diabetes and Endocrinology

PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

PEP-CoV 프로토콜: 초기 COVID-19에서 호흡기 악화 및 입원을 예방하기 위한 PEP 플루트 자가 관리 무작위 대조 시험

Article

Published on 2021-06-302022-09-11
Journal: BMJ Open [Category] SARS, 임상,

[키워드] activities activity assessment Chest chest tightness chronic pulmonary disease clinical trials cohort of patient collapse Contact control arm COPD cough Course COVID-19 COVID-19 symptoms daily living Deterioration disease Dyspnoea Effectiveness enrolment Ethical approval Ethics expiratory Expiratory Pressure Follow-up Health Healthcare systems high mortality rate hospital Hospital admission hospitalisation hypothesise individual Infectious diseases Intervention intervention group journal Local measure non-hospitalised Nurse offer pandemic participant Patient phlegm Pneumonia Prevent Preventive medicine Primary outcome Prognosis public health pulmonary disease randomised controlled trial Randomised trial receive recruit Registered registration number Research Ethics Research Ethics Committee respiratory medicine (see thoracic medicine) respiratory symptom respiratory symptoms Result Safe SARS-CoV-2 SARS-COV-2 infection secondary outcome self-care severe pulmonary disease shown sleep quality susceptibility symptom severity Symptoms Test Thoracic Treatment Trial usual care
[DOI] 10.1136/bmjopen-2021-050582 PMC 바로가기 [Article Type] Article

High anti-SARS-CoV-2 antibody seroprevalence in healthcare workers in an Irish university teaching hospital

아일랜드 대학 교육 병원의 의료 종사자에서 높은 항 SARS-CoV-2 항체 혈청 유병률

Original Article

Published on 2021-06-302022-09-10
Journal: Irish Journal of Medical Science [Category] COVID19(2023년), MERS, SARS, 진단, 치료기술, 치료법,

[키워드] age analysed anti-SARS-CoV-2 anti-SARS-CoV-2 antibody antibody Antibody test antibody test result approved Asymptomatic Care Chain Reaction collected consent form Contact correlated COVID-19 infection COVID-19 pandemic detect Elecsy ethics committee evaluated Germany healthcare worker Healthcare workers high risk highest hospital Infection information less molecular nucleocapsid protein participant Participation Patient patients phlebotomy polymerase chain polymerase chain reaction proportion provided questionnaire reactive real-time polymerase chain reaction Research Ethics Result risk Roche Diagnostics SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 infections SARS-CoV-2 RNA Seropositivity Seroprevalence serum sample serum samples staff Swab test result tested total antibodies total antibody Transmission Volunteer
[DOI] 10.1007/s11845-021-02690-4 PMC 바로가기 [Article Type] Original Article

Adherence with reporting of ethical standards in COVID-19 human studies: a rapid review

Research

Published on 2021-06-282022-10-28
Journal: BMC Medical Ethics [Category] COVID-19, Fulltext, MERS, SARS,

[키워드] Abstract adherence approval article articles Case series case sery Clinical practice Clinical research clinical trials Combination Committee Compliance conducted COVID-19 Declaration of Helsinki determine eligible ethical guideline ethical standard ethical standards Filter Good Clinical Practice ICMJE include Informed consent journal literature review majority observational studies observational study outcome pandemic participant Participants Patient and public involvement promote PROTECT random REC repeated Reporting Research Research Ethics Research Ethics Committee researcher Result supplementary material Support was performed were excluded while with COVID-19
[DOI] 10.1186/s12910-021-00649-9 PMC 바로가기 [Article Type] Research