Effectiveness of Community-Delivered Functional Power Training Program for Frail and Pre-frail Community-Dwelling Older Adults: a Randomized Controlled StudyRandomized Controlled Trial Published on 2021-03-192022-10-04 Journal: Prevention science : the official journal of the S [Category] MERS, SARS, 임상, [키워드] activities activity baseline battery Community conducted Controlled demonstrated Effectiveness equipment evaluated exercise exhibited feasible frailty functional greater implementation Intervention Local low handgrip strength multicenter Muscle strength no effect offered Older participant performance physical Physical function power Program Program implementation Randomized Randomized controlled trial reduce Registered reported Result Senior activity centers significantly Singapore stratified Successful aging supplementary material training Two-arm were assessed [DOI] 10.1007/s11121-021-01221-y PMC 바로가기 [Article Type] Randomized Controlled Trial
High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial (CARED-TRIAL)COVID-19 환자의 합병증을 예방하기 위한 고용량 비타민 D 대 위약: 무작위 대조 시험(CARED-TRIAL)을 위한 연구 프로토콜의 구조화된 요약Letter Published on 2021-02-012022-09-10 Journal: Trials [Category] MERS, 임상, [키워드] 1:1 24 hour 24 hours Admission age allergy ambient and vitamin D anticonvulsants assessment Asthma Blinding block Blood body mass body mass index breathing ambient air calcium cardiovascular cardiovascular disease carried charge childbearing childbearing age cholecalciferol chronic Chronic kidney disease clinical clinical complications clinical outcomes comparator Complete Complication computer-generated Contact COPD coronary artery bypass grafting country COVID-19 COVID-19 patient COVID-19 patients criteria current death diabete diabetes discharge discretion disease dissemination dose double-blind Effect element enrolled evaluate exclusion exclusion criteria failure first stage FIVE gel Gender grafting Haemodialysis High dose history hospital Hospital admission hospital discharge Hospitalization hypercalcemia hypertension IMPROVE include inclusion criteria Infection Informed consent initiated Intervention invasive invasive or non-invasive ventilation investigator investigator-initiated investigators Kidney disease Life expectancy liver malabsorption management matching placebo mechanical ventilation medication moderate multicentre Myocardial infarction Non-invasive non-invasive ventilation number objective occur Occurrence oral cholecalciferol oral intake Organ failure outcome oxygen oxygen saturation Oxygenation packaged pandemic PaO participant Patient patients performed Pharmacist pharmacological physiological effects Placebo placebo-controlled clinical trial Pneumonia Pragmatic Prevent Primary outcome protocol pulse oximetry random randomised randomised controlled trial randomization randomization ratio Randomized recorded recruited recruitment Registered reported Requirement researcher respiratory Respiratory outcome respiratory outcomes risk routine clinical practice RT-PCR Sample size sarcoidosis SARS-CoV-2 Sepsis sequence sequential design serum calcium Seven stages Standard status stratified study drug study medication Study protocol subject supplementary material total sample size Treatment Trial Trial registration Two-arm valve replacement variable Vitamin D Vitamin D supplementation was used website [DOI] 10.1186/s13063-021-05073-3 PMC 바로가기 [Article Type] Letter
A structured summary of a study protocol for a multi-center, randomized controlled trial (RCT) of COVID-19 prevention with Kampo medicines (Integrative Management in Japan for Epidemic Disease by prophylactic study: IMJEDI P1 study)Kampo 의약품을 사용한 COVID-19 예방에 대한 다기관, 무작위 대조 시험(RCT) 연구 프로토콜의 구조화된 요약(예방 연구에 의한 전염병에 대한 일본의 통합 관리: IMJEDI P1 연구)Letter Published on 2021-01-062022-08-31 Journal: Trials [Category] MERS, 임상, 치료제, [키워드] 1:1 administration age allergic Analysis appearance Arm ARMS assumed Asymptomatic balancing Blinding body temperature calculated capture cardiovascular disease Chain Reaction clinical clinical trials cloud condition Control control group cough COVID-19 diabetes disappearance dissemination doctor dosage dropout rate drug edema effective element Endpoint exclusion criteria failure Fever Final final analysis final analysis) Frequency group hands healthy history hospital Hospitalization hypertension hypokalaemia Hypothesis ICU Immunosuppressant immunosuppressants incidence of COVID-19 incidence rate incidence rates include inclusion criteria Infection infection rate Inflammation interim analysis interstitial pneumonia intervention group investigator Japan Japanese Kampo Kampo medicines liver dysfunction lung malaise management mechanical ventilation Medicine number numbness objective observation period oral administration oral administration) outcome package parallel-group participant Patient PCR PCR positive per day Period pharmaceutical Placebo placebo group Placebo tablets positive result power power of 80% pregnant Prevent Prophylactic prophylactic study protocol randomised Randomized Randomized controlled trial RCT receive recruited Registered Registration registry required Research respiratory respiratory diseases respiratory inflammation risk factor Risk factors Safety Sample size SARS-CoV-2 RNA secondary Secondary outcomes Shock Shortness of breath significantly skin rash sputum study drug study period Study protocol supplementary material Symptom Symptoms symptoms of COVID-19 Tablet Taking Taste the placebo group Trial Trial registration Two-arm university upper respiratory verification Viral viral infection Vital website [DOI] 10.1186/s13063-020-04939-2 PMC 바로가기 [Article Type] Letter
Prophylactic dressings in the prevention of pressure ulcer related to the use of personal protective equipment by health professionals facing the COVID-19 pandemic: A randomized clinical trialRandomized Controlled Trial Published on 2021-01-012022-10-05 Journal: Wound repair and regeneration : official publication of the Wound Healing [Category] SARS, 임상, [키워드] addition adopted adverse effect affecting average baseline Care Characteristics collected condition control group coronavirus COVID-19 dimension effective group Health Injury left ear no difference Personal protective equipment physical PPE Prevent professional professionals Psychological randomized clinical trial regions right ear significance level statistical Two-arm [DOI] 10.1111/wrr.12877 PMC 바로가기 [Article Type] Randomized Controlled Trial
Adaptive platform trials using multi-arm, multi-stage protocols: getting fast answers in pandemic settings다단계, 다단계 프로토콜을 사용하는 적응형 플랫폼 시험: 전염병 상황에서 빠른 답변 얻기Opinion Article Published on 2020-11-232022-09-11 Journal: F1000Research [Category] MERS, 임상, [키워드] accumulating acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adaptive Adaptive platform trial approach benefit Clinicians competing conduct conducted control arm coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 determine effective interventions efficient Epidemic FAME faster greater Health Health care Health care system health care systems help identify in-silico In-vitro inefficient Infection Interim analyses interim analysis International Intervention investigated IPD limitation majority MAMS Meta-analysis multi-arm multi-stage not used overcome pandemic Pandemics patients platform Platform trial potential therapeutic agent potential therapeutic agents Potential treatment promise provide Randomised clinical trials recruitment respiratory SARS-CoV-2 Sequencing severe acute respiratory syndrome Coronavirus significantly solution Standard-of-care subsequent therapeutic agents Treatment Trial trials Two-arm Vaccinations well [DOI] 10.12688/f1000research.26253.2 PMC 바로가기 [Article Type] Opinion Article
A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RCT) on the use of Kampo medicine, kakkonto with shosaikotokakikyosekko, in mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trialLetter Published on 2020-10-022022-10-29 Journal: Trials [Category] COVID-19, MERS, SARS, [키워드] 1:1 Ability to communicate acute respiratory syndrome addition administration age Analysis antipyretics Arm Blinding calculated clinical clinical trial Combination common cold-like symptom control group coronavirus cough COVID-19 COVID-19 patient criteria decrease defined Dementia difficulty dissemination effective Efficacy element exclusion criteria fatigue female Fever Follow-up group H1N1 influenza hospitals Hypothesis IMPROVE in both group include Inclusion Infection Inpatient Japan Japanese Kampo Kampo medicines lactating less malaise Medicine Mild-to-moderate number objective occurred outcome Outpatient parallel-group participant Patient patients positive Prevention for severe stage previous study protocol Psychiatric random Randomized Randomized controlled trial receive recruited registry required Research Sample size SARS-CoV-2 Severe infection Severity of disease Shortness of breath significance level significantly sputum Stage steroid Study protocol survival survival curve Symptom Symptom relief symptomatic temperature the Kaplan-Meier method the log-rank test the median the primary endpoint the SARS-CoV-2 to define treated Treatment Two-arm website [DOI] 10.1186/s13063-020-04746-9 PMC 바로가기 [Article Type] Letter
Potential Role of Acacia Senegal (Gum Arabic) as Immunomodulatory Agent among newly diagnosed COVID 19 Patients: A structured summary of a protocol for a randomised, controlled, clinical trialLetter Published on 2020-09-052022-10-29 Journal: Trials [Category] Coronavirus, SARS, [키워드] 1:1 Acacia addition agent Anti-inflammatory Arabic assigned assistant baseline baseline value blind change Clinical guidelines clinical trial computer-generated conducted Control COVID COVID 19 COVID 19 patient COVID-19 COVID-19 patients CRP Cytokines Date death diagnosed dissemination Efficacy element eligible patient Factor Gender group groups Gum Gum Arabic Hospital admission IL10 IL6 IL8 immunomodulation immunomodulatory independent Intervention Local mortality rate number objective outcome parallel-group participant Patient patients PCR Pectin phase Placebo placebo-controlled clinical trial Potential Prospective protocol provided random randomised randomised controlled trial randomization Randomized Randomly Real-time PCR receive Research response role Sample size secondary sequence seropositive Soba standard care state status TNFα Treatment Trial Tumor Two-arm university Version Viral load website [DOI] 10.1186/s13063-020-04707-2 PMC 바로가기 [Article Type] Letter
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
Impact of Shenfu injection on a composite of organ dysfunction development in critically ill patients with coronavirus disease 2019 (COVID-19): A structured summary of a study protocol for a randomized controlled trialLetter Published on 2020-08-242022-10-29 Journal: Trials [Category] COVID-19, MERS, [키워드] 1:1 28-day mortality 48 hours adopted allergic allergy allocation concealment alveolar baseline bleeding blinded Blinding block randomization both group breastfeeding women caused China Chinese clinical clinical trial conducted control group coronavirus disease COVID-19 criteria Critical Critically ill patient death defined determine Diagnosis dissemination distribution element enrolled enrolment event exacerbated expected HIV hospital hospital cost ICU immunosuppressive drug Impact incidence include increase in injection intensive care Length lung malignant tumor management guideline multicenter National Health Commission number objective Obstructive Open-label organ organ dysfunction Organ failure outcome parallel group participant Patient patient recruitment patients patients with COVID-19 Pneumonia pregnant primary endpoint protocol provided pulmonary interstitial fibrosis random randomised randomised controlled trial randomization Randomized Randomized controlled trial Randomly receive recruit recruited researchers Sample size SAS sealed secondary endpoint Sepsis Seven severe malnutrition severity Shenfu injection shown SOFA SOFA score statistical status study group Study protocol supportive therapy the patient Total treat Treatment Two-arm underlying disease usual care vasoactive drug Volume website [DOI] 10.1186/s13063-020-04677-5 PMC 바로가기 [Article Type] Letter
A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial보행식 COVID-19에서 아지트로마이신 대 일반 치료의 다기관 공개 라벨 2군 무작위 우월성 임상 시험: ATOMIC2 시험을 위한 연구 프로토콜Study Protocol Published on 2020-08-172022-08-13 Journal: Trials [Category] MERS, 임상, [키워드] 1:1 Adults age all-cause mortality Ambulatory care Analysis anti-bacterial Anti-inflammatory anti-inflammatory properties antibiotic antiviral properties antiviral property Azithromycin Bacterial infection Biomarkers Blood Care Clinical diagnosis clinical trial clinical utility clinically Coronavirus disease 2019 Coronavirus infections Course COVID-19 COVID-19 infection COVID-19 symptoms cytokine Cytokines death determine diagnosed disease early disease EudraCT Follow-up G-CSF GM-CSF hospital include initial Interleukins invasive Macrolide management mechanical ventilation MERS-CoV moderate moderate to severe Mortality multi nasal Non-invasive non-invasive mechanical ventilation ongoing trial Open-label Opened Other pandemic coronavirus participant pathway Patient PCR-confirmed PCR-confirmed diagnosis presenting pro-inflammatory cytokine pro-inflammatory cytokines progression proportion randomisation randomised reduce Respiratory failure risk Safe SAR-CoV-2 SARS-CoV secondary bacterial infection Secondary objective Secondary objectives severe disease severe pneumonia severe SARS severity severity of illness standard care Study protocol suppression Symptom Symptoms Therapeutic benefit therapy treat Trial Trial registration Two-arm usual care with COVID-19 [DOI] 10.1186/s13063-020-04593-8 PMC 바로가기 [Article Type] Study Protocol