Hepatitis A Virus Infection in Cynomolgus Monkeys Confounds the Safety Evaluation of a Drug CandidateOriginal Article Published on 2024-03-192024-09-05 Journal: International Journal of Toxicology [Category] update2024, [키워드] cynomolgus monkey Drug development hepatic pathology hepatitis A virus hepatotoxicity non-human primate safety evaluation toxicology [DOI] 10.1177/10915818241237992 PMC 바로가기 [Article Type] Original Article
Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women Research Published on 2022-08-242022-10-05 Journal: Scientific Reports [Category] 변종, [키워드] administration healthy men and women safety evaluation [DOI] 10.1038/s41598-022-18272-y [Article Type] Research
Safety evaluation of the single-dose Ad26.COV2.S vaccine among healthcare workers in the Sisonke study in South Africa: A phase 3b implementation trial남아프리카의 Sisonke 연구에서 의료 종사자를 대상으로 한 단회 용량 Ad26.COV2.S 백신의 안전성 평가: 3b상 시행 시험Clinical Trial Published on 2022-06-212022-09-12 Journal: PLoS Medicine [Category] MERS, 임상, 진단, [키워드] 48 hour Ad26.COV2.S vaccine adverse event AEs African age body ache breakthrough infections categories clinical clinical trials collected COVID-19 COVID-19 infection death demonstrated Effectiveness eligible evaluated expected Fever Final first vaccination Frequency HCW HCWs headache healthcare healthcare worker hospitalisations Immune system disorder implementation Implementation study IMPROVE incidence rate increasing age Infection injection site pain janssen men morbidity MOST National nervous system disorder occurred Open-label Pan participant Participants Phase 3 trials reactogenicity reactogenicity event Registered registry reported SAE SAEs safety evaluation safety profile serious AE single-arm design South South Africa Support Symptoms syndrome System thrombosis Trial triggered vaccination Vaccine [DOI] 10.1371/journal.pmed.1004024 PMC 바로가기 [Article Type] Clinical Trial
Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)새로운 SARS-CoV-2 항바이러스제 시험을 위한 국제, 다군, 다단계 플랫폼 마스터 프로토콜의 설계 및 구현: COVID-19 입원 환자를 위한 치료제(TICO/ACTIV-3)Article Published on 2022-02-012022-09-11 Journal: Clinical Trials (London, England) [Category] 임상, 치료제, [키워드] adults hospitalized agent Antiviral Antiviral agents applicability approach approaches approval clinical trial collaboration Consent Forms COVID-19 Data collection drug effective therapy Efficacy enrolled Evidence evidence of expected facilitate feature FIVE food Food and Drug Administration forms harmonization hospitalized patient hospitalized patients implementation infection rate infection rates information initiated Inpatient Inpatients International matching placebo multi-arm multi-arm multi-stage Other outbreak overcome participant participated Patient Placebo platform platform trials. potential therapeutic agent potential therapeutic agents protocol provided Randomized Rapid recruitment Regulatory required robust safety evaluation Safety Monitoring Board safety profile Sample size SARS-CoV-2 Stage subsequent target population therapeutic agent Therapeutics Trial trials with COVID-19 [DOI] 10.1177/17407745211049829 PMC 바로가기 [Article Type] Article
Development of an Inactivated Vaccine against SARS CoV-2SARS COV-2에 대한 불활성 백신의 개발Article Published on 2021-11-022022-09-10 Journal: Vaccines [Category] 비임상, [키워드] Adenovirus Aluminium aluminium hydroxide animal models approved AstraZeneca BALB/c mice breath candidate candidate vaccine changed clinical development clinical trial Complete COVID-19 COVID-19 pandemic COVID-19 vaccine develop development Device distribution Efficacy elicited Emergency use ERUCoV-VAC ferrets hACE2 HCoV help human clinical trial human clinical trials hydroxide immunogenic immunogenicity inactivated Inactivated vaccine include Johnson & Johnson K18-hACE2 Medical devices Medicine mice Moderna mRNA name outbreak Pfizer-BioNTech Phase 3 phase 3 clinical trial progression Protective respiratory safety evaluation SARS CoV-2 SARS-CoV-2 SARS-CoV-2 vaccine Sinopharm Sinovac Spread strain strong immune response the vaccine the WHO transgenic mice TURKOVAC university upper respiratory tract upper respiratory tracts Vaccine vaccine candidate Vaccines Viral viral clearance rate Viral vector viral vectors was used [DOI] 10.3390/vaccines9111266 PMC 바로가기 [Article Type] Article
Bispecific repurposed medicines targeting the viral and immunological arms of COVID-19Covid-19의 바이러스 및 면역 학적 무기를 대상으로하는 이중 특이 적 용도의 의약품Article Published on 2021-06-242022-08-31 Journal: Scientific Reports [Category] 신약개발, 유전자 메커니즘, 치료제, [키워드] Anti-inflammatory Anti-viral approval Arm benefit candidate Candidates caspase caspase-1 clinical evaluation conserved coronavirus Coronavirus infection Coronavirus replication coronavirus strain coronavirus strains COVID-19 drug Drug discovery Enzyme mechanisms epidermal epidermal growth factor growth factor High-throughput screening Human immunological inhibitor M pro Medicine outbreak Outbreaks Papain-like protease protease Protecting Remdesivir reported required safety evaluation SARS-CoV-2 target targets Tarloxotinib therapeutic agents treat X-ray crystallography [DOI] 10.1038/s41598-021-92416-4 PMC 바로가기 [Article Type] Article
Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine: Preclinical Studies비활성화된 SARS-CoV-2 백신의 면역원성과 안전성: 전임상 연구Article Published on 2021-03-032022-09-10 Journal: Vaccines [Category] 비임상, [키워드] Antibody titers approved AstraZeneca booster booster dose breath candidate vaccine challenge clinical development clinical trial control group country effective Efficacy Emergency use experimental models guinea pigs hamster hamsters immunogenicity immunological profile inactivated increase in Infection Laboratory mice Moderna morbidity mRNA Neutralizing antibody titer neutralizing antibody titers pandemic performed Phase I PIGS post vaccination pre-clinical study Preclinical preclinical studies RATs Safety safety evaluation SARS-CoV-2 SARS-CoV-2 vaccine shedding Sinopharm subjects tested the vaccine tolerable Vaccine vaccine safety virus [DOI] 10.3390/vaccines9030214 PMC 바로가기 [Article Type] Article
Safety evaluation of the canine osteosarcoma vaccine, live Listeria vector개 골육종 백신, 살아있는 리스테리아 벡터의 안전성 평가Article Published on 2021-03-012022-09-11 Journal: Veterinary and comparative oncology [Category] Coronavirus, 비임상, [키워드] 24 hour 24 hours abscess administration Adverse adverse events AEs Analysis Bacterial breath Cancer cancer vaccines canine caution clinically conjunction diagnosed dogs event family Fever Health care Health care worker health care workers immune modulation immunogenic Immunotherapy Infection initial joint lethargy Listeria Listeria monocytogenes listeriosis listeriosis. lung lyophilized formulation Mild nausea necropsy observational study OSA osteosarcoma outcomes Patient patients treated positive receiving reported required safety evaluation self-limiting septic shown Standard-of-care Stifle joint survival the patient the vaccine therapeutic Thoracic Treatment vaccination Vaccinations Vaccine Vaccines were recorded zoonotic [DOI] 10.1111/vco.12642 PMC 바로가기 [Article Type] Article
Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial중증 신종 코로나바이러스 폐렴(COVID-19) 환자의 폐 기능 및 삶의 질을 위한 지압 요법 및 Liu Zi Jue Qigong: 무작위 대조 시험을 위한 연구 프로토콜Study Protocol Published on 2020-08-272022-08-13 Journal: Trials [Category] MERS, 임상, [키워드] 1:1 2019 novel coronavirus activities activity Acupressure Acupressure therapy addition Admission Adverse adverse events analyst assessor-blinded assessment assessments assigned Barthel Index both groups can be used Chinese Chinese Clinical Trial Registry clinical clinical scale clinical scales complementary Controlled trial COVID-19 Daily discharge Dyspnea effective therapy Efficacy evaluate event Evidence evidence of Hospitalization in both group include intervention group Liu Zi Jue Qigong Liu Zi Jue Qigong exercises Medical Research Council Modified Medical Research Council Dyspnea Scale Novel coronavirus parallel-design Patient Patient Health Questionnaire-9 Scale patients with COVID-19 performed Pneumonia poor prognosis Primary outcome Pulmonary function Qigong Qigong exercise Qigong exercises Quality of life Randomized controlled trial randomized trial Randomly receive recorded recruited registry rehabilitation respiratory Respiratory Symptoms Scale safety evaluation scale secondary outcome Secondary outcomes severe COVID-19 severe disease Study protocol supportive care symptomatic TCMR therapy therapy for COVID-19 Traditional Chinese medicine Traditional Chinese medicine rehabilitation Treatment Trial twice a day Two-arm Wuhan Wuhan, China [DOI] 10.1186/s13063-020-04693-5 PMC 바로가기 [Article Type] Study Protocol