Phase 2 – Page 4 – Communicable Diseases Research

Fostamatinib for the treatment of warm antibody autoimmune hemolytic anemia: Phase 2, multicenter, open-label study

Clinical Trial

Published on 2022-06-012022-10-05
Journal: American journal of hematology [Category] 임상,

Early Th2 inflammation in the upper respiratory mucosa as a predictor of severe COVID-19 and modulation by early treatment with inhaled corticosteroids: a mechanistic analysis

중증 COVID-19의 예측인자로서 상부 호흡기 점막의 초기 Th2 염증 및 흡입 코르티코스테로이드 조기 치료에 의한 조절: 기계론적 분석

Clinical Trial

Published on 2022-06-012022-09-11
Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 바이오마커, 신약개발, 임상, 치료법, 치료제,

[키워드] 1:1 adaptive airway Analysis Anti-viral antipyretics assigned AstraZeneca Biomarker Blood blood sample Blood samples Budesonide CCL17 chemokine clinical benefit clinical symptom clinical trial clinically Cohort collected Concentration Corticosteroid Course COVID-19 COVID-19 disease COVID-19 disease course Data collection decrease deteriorate dose early treatment Efficacy elevated enzyme eosinophil epithelial epithelial lining Evolution experimental analysis healthy controls healthy individuals IL-33 immunoassay individual Inflammation Inflammatory Inflammatory mediators Inflammatory response Inhaled inhaled budesonide inhaled corticosteroid initial interferon interferon response interleukin Intervention investigated Ligand marker mechanism Meso Scale Discovery modulated modulation mucosa mucosal nasal Nasal sample nasal samples Necrosis negative control nose Observational data open label outcomes over Oxford parallel group participant Patient patients with SARS-CoV-2 Phase 2 Primary outcome Proteins randomisation randomised Randomly receive recruited reducing Registered respiratory tract SARS-COV-2 infection severe COVID-19 severe COVID-19 disease shown systemic inflammation T-cell Response Th2 the SARS-CoV-2 Treatment Trial tumour necrosis factor tumour necrosis factor-α twice a day University of Oxford upper respiratory usual care usual care group was collected were assessed were used Whole blood with COVID-19
[DOI] 10.1016/S2213-2600(22)00002-9 PMC 바로가기 [Article Type] Clinical Trial

Effectiveness of home-based cardiac telerehabilitation as an alternative to Phase 2 cardiac rehabilitation of coronary heart disease: a systematic review and meta-analysis

관상 동맥 심장 질환의 2상 심장 재활의 대안으로 재택 심장 원격 재활의 효과: 체계적인 검토 및 메타 분석

Meta-Analysis

Published on 2022-05-252022-09-11
Journal: European journal of preventive cardiology [Category] 임상,

[키워드] 95% CI 95% confidence interval alternative cardiac Cardiac rehabilitation CENTRAL CHD CINAHL controlled trials Coronary Coronary heart disease COVID-19 pandemic Depression depression score depression scores Effect effective Effectiveness feasible functional functional capacity heart disease Home-based Hospitalization inception increase in life medication Mental Meta-analysis Mobile Mobile application Odds ratio Participation Patient Phase 2 physical physical activity physiological PsycINFO Quality of life Randomized controlled trial RCT RCTs rehabilitation Risk factors searched smoking Suspension systematic review telerehabilitation usual care Web-based
[DOI] 10.1093/eurjpc/zwab106 PMC 바로가기 [Article Type] Meta-Analysis

INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

새로 진단된 제1형 당뇨병을 가진 소아, 청소년 및 성인을 대상으로 한 임상시험 의약품 평가를 위한 INNODIA 마스터 프로토콜

Article

Published on 2022-05-182022-09-11
Journal: Trials [Category] COVID19(2023년), SARS, 바이오마커,

[키워드] adaptive adolescents and adult backbone baseline benefit Beta-cell function Biomarker Biomarkers C-peptide children Clinical data clinical sample clinical samples clinical trials Combination combination therapies comparable control group Decline demonstrated determine diabete diabetes diagnosed dosage Efficacy Efficacy and safety Endpoint evaluate greater identification identify IMPROVE include individual investigational medicinal product lack Master protocol mechanistic data natural history participant phase Phase 2 phase 2 clinical trials phase 2 studies Phase 2 study phase 3 study Prevent prevention product provide response robust sample size calculation Stratification subsequent trials Type 1 diabetes Variation
[DOI] 10.1186/s13063-022-06259-z PMC 바로가기 [Article Type] Article

Immunogenicity and Safety of a 3-Dose Regimen of a SARS-CoV-2 Inactivated Vaccine in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

성인을 위한 SARS-CoV-2 비활성화 백신의 3회 용량 요법의 면역원성 및 안전성: 무작위, 이중 맹검, 위약 대조 2상 시험

Clinical Trial

Published on 2022-05-162022-09-12
Journal: The Journal of Infectious Diseases [Category] COVID19(2023년), MERS, SARS, 임상, 진단,

[키워드] 3-dose regimen acute respiratory syndrome Adults Adverse AEs antibody Antibody Response Control coronavirus dose doses double-blind Effective vaccines elicited event geometric mean titer GMT GMTs immune response immunogenicity Immunoglobulin inactivated Inactivated vaccine Injection-site pain intensity Neutralizing Neutralizing antibodies Older pandemic percentage Phase 2 Placebo placebo-controlled trial predominant pseudovirus Randomized receive Receptor binding domain robust Safety safety profile SARS-CoV-2 SARS-CoV-2 inactivated vaccine second dose separated serious AE tested the vaccine vaccination Vaccine virus were recorded
[DOI] 10.1093/infdis/jiab627 PMC 바로가기 [Article Type] Clinical Trial

Repair of acute respiratory distress syndrome by stromal cell administration (REALIST): a structured study protocol for an open-label dose-escalation phase 1 trial followed by a randomised, triple-blind, allocation concealed, placebo-controlled phase 2 trial

간질 세포 투여에 의한 급성 호흡 곤란 증후군의 회복(REALIST): 공개 라벨 용량 증량 1상 시험에 이어 무작위, 삼중 맹검, 할당 은폐, 위약 대조 2상 시험을 위한 구조화된 연구 프로토콜

Article

Published on 2022-05-132022-09-11
Journal: Trials [Category] COVID19(2023년), SARS, 임상,

[키워드] 1:1 acute respiratory distress acute respiratory distress syndrome administration allocation ARDS benefit blind causes Cell cells clinical clinical trial Cohort cohort of patient cohorts of patients concealed CONSORT COVID-19 distress dose dose-escalation early stage early stages Efficacy EudraCT Good immunomodulatory incidence include Mesenchymal stem cells Mesenchymal stromal cell Mesenchymal stromal cells moderate to severe MSC MSCs multicentre NHS number Open-label outcome outlined oxygenation index patients patients with moderate Phase 1 phase 1 trial Phase 2 phase 2 trial Placebo placebo-controlled placebo-controlled trial Practice produced protocol randomised rationale receive recruited recruitment repair reported Reporting respiratory distress Respiratory distress syndrome Serious Adverse Events severe ARDS Standard stromal cell stromal cells Study protocol syndrome therapy Trial triple-blind umbilical Umbilical cord
[DOI] 10.1186/s13063-022-06220-0 PMC 바로가기 [Article Type] Article

Development, implementation and evaluation of the online Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program: The protocol for a pilot trial

Article

Published on 2022-05-122022-10-05
Journal: PLoS ONE [Category] 임상,

Re: Chen Dong, Sung-Lang Chen, and Wen-Wei Sung’s Letter to the Editor re: Karin Welén, Ebba Rosendal, Magnus Gisslén, et al. A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data. Eur Urol. 2022;81:285-93

Re: Chen Dong, Sung-Lang Chen, Wen-Wei Sung이 편집자에게 보낸 편지 re: Karin Welén, Ebba Rosendal, Magnus Gisslén, et al. COVID-19 결과에 대한 항안드로겐 요법의 효과에 대한 2상 시험: 역학 및 시험관 데이터에 의해 뒷받침되는 이익의 증거 없음. 에르 우롤. 2022;81:285-93

Comment

Published on 2022-05-012022-09-11
Journal: European urology [Category] Coronavirus, 임상,

[키워드] antiandrogen COVID-19 Effect evidence of Magnus Phase 2
[DOI] 10.1016/j.eururo.2022.02.001 PMC 바로가기 [Article Type] Comment

Re: Karin Welén, Ebba Rosendal, Magnus Gisslén, et al. A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome: No Evidence of Benefit, Supported by Epidemiology and In Vitro Data. Eur Urol. 2022;81:285-293

재: Karin Welén, Ebba Rosendal, Magnus Gisslén, et al. COVID-19 결과에 대한 항안드로겐 요법의 효과에 대한 2상 시험: 역학 및 시험관 데이터에 의해 뒷받침되는 이익의 증거 없음. 에르 우롤. 2022;81:285-293

Comment

Published on 2022-05-012022-09-11
Journal: European urology [Category] 임상,

[키워드] antiandrogen COVID-19 Effect evidence of Magnus Phase 2
[DOI] 10.1016/j.eururo.2022.01.048 PMC 바로가기 [Article Type] Comment

Immune response to SARS-CoV-2 after a booster of mRNA-1273: an open-label phase 2 trial

mRNA-1273 부스터 후 SARS-CoV-2에 대한 면역 반응: 공개 표지 2상 시험

Clinical Trial

Published on 2022-05-012022-09-11
Journal: Nature Medicine [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, 치료기술,

[키워드] 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Adverse reactions anti-Spike IgG antibody Antibody titer Antibody titers B.1.617.2 booster booster dose booster injection Booster vaccine Breakthrough infection caused Cell coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 criterion delta variant disease dose Effectiveness elicited ELISA evaluated exploratory follow-up period Frequency immunized immunogenicity individual Infection injection Local memory B memory B cell Meso Scale Discovery mRNA mRNA-1273 MSD NAb NAb titers neutralizing antibody non-inferiority non-randomized Open-label participant Phase 2 phase 2 trial Phase 3 primary immunogenicity raised reported respiratory Safe SARS-CoV-2 second dose Serious Adverse Event Serious Adverse Events severe acute respiratory syndrome Coronavirus significantly higher statistically systemic adverse reaction systemic adverse reactions titers vaccination Vaccine variants wild-type SARS-CoV-2
[DOI] 10.1038/s41591-022-01739-w PMC 바로가기 [Article Type] Clinical Trial