Secondary endpoints – Page 5 – Communicable Diseases Research

Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial

ARDS 및 COVID-19 환자에서 덱사메타손의 효과 – 전향적, 다기관, 공개 라벨, 병렬 그룹, 무작위 대조 시험(REMED 시험): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-03-012022-09-10
Journal: Trials [Category] SARS, 임상, 치료기술,

Effect of a genetically engineered interferon-alpha versus traditional interferon-alpha in the treatment of moderate-to-severe COVID-19: a randomised clinical trial

중등도에서 중증의 COVID-19 치료에서 유전적으로 조작된 인터페론-알파 대 전통적인 인터페론-알파의 효과: 무작위 임상 시험

Randomized Controlled Trial

Published on 2021-02-232022-08-09
Journal: Annals of Medicine [Category] 임상, 치료제,

[키워드] 1:1 95% CI acute respiratory syndrome acute respiratory syndrome coronavirus adaptive immune responses added Adverse adverse events Alpha antiviral agent Antiviral agents antiviral therapy ARMS assigned baseline antiviral agent baseline antiviral agents Clinical efficacy Clinical improvement clinical trial coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 death Effect effective therapy Effectiveness Endpoint event groups head immune responses interferon Interferon alpha interferon-alpha interferon-alpha group interferon-alpha nebulization Lopinavir Lopinavir–ritonavir lopinavir–ritonavir or umifenovir Middle East Middle East respiratory syndrome Coronavirus moderate-to-severe COVID-19 multicenter Negative conversion nucleic acid outbreak pandemic participant Patient patients hospitalized primary endpoint radiological improvement randomised Randomized recombinant super-compound interferon respiratory respiratory syndrome coronavirus Result Ritonavir rSIFN-co rSIFN-co group rSIFN-co nebulization rSIFN-co therapy SARS CoV-2 secondary Secondary endpoints severe acute respiratory syndrome Coronavirus shown traditional interferon-alpha Treatment Trial umifenovir virus nucleic acid
[DOI] 10.1080/07853890.2021.1890329 PMC 바로가기 [Article Type] Randomized Controlled Trial

Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial

COVID-19 대유행 중 ARDS 환자의 임상 결과에 대한 정맥내 리도카인의 영향(LidoCovid): 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-02-112022-09-10
Journal: Trials [Category] MERS, 임상,

[키워드] 1:1 24 hour 24 hours acute renal failure acute respiratory distress acute respiratory distress syndrome Admission adverse event adverse events age albumin All participant All participants Anti-inflammatory effects approved aPTT ARDS Atrial fibrillation Bacterial Berlin Beta Bicarbonate biological sample biological samples blinded Blinding blockers blood count bolus bronchospasm cardiac rhythm Cardiogenic shock Care care providers Child bearing clinical Clinical data Clinical outcome clinical study collected Commission comparator complete blood count Complication computer-generated Concentration conducted Consumption control group cough COVID-19 COVID-19 pneumonia Covid-19 subgroup CRP D-dimers delirium diagnostic Disease progression disorders dissemination distribution Distribution ratio dosage Effect element ethics committee evaluate the effect evaluated Evolution experimental group extubation ferritin fibrinogen FiO2 followed by following form France French Gas exchange HCG Hospitalized hypnotics ICU IL-6 Ileus Impact incidence include inclusion criteria Inflammation Inflammatory marker inflammatory markers intensive care intensive care unit interval intervention group intravenous Intubated investigator LDH Length lidocaine Local local anaesthetics Local anesthetics Lymphocytes moderate moderate to severe Modification molecular mechanisms of pharmacological action Mortality NaCl number objective Older opioids outcome Pandemia PaO2 PaO2/FiO2 ratio parallel group participant Patient patients with ARDS PCT Phase 3 Placebo placebo-controlled Platelets Pneumonia pneumopathy Pneumothorax Prevent Primary outcome protection Protective protocol QTc random randomisation randomised randomised controlled trial randomize Randomized Randomly receive Recovery time recruitment Registered Renal Dialysis renal failure report respiratory distress RT-PCR Sample size SARS-CoV2 infection secondary endpoint Secondary endpoints sedated Severe acute respiratory syndrome severe ARDS Shock Social Security Social security system sore throat status Stratification stroke Study protocol supplementary material surgical syndrome tetraplegia thromboembolic Thromboembolic event timepoint Toxicity Treatment Trial Trial registration triglycerides troponin two group two groups university vasopressors Ventilation ventilator ventilator-free day Ventilator-free days website women written Informed Consent
[DOI] 10.1186/s13063-021-05095-x PMC 바로가기 [Article Type] Letter

Evaluation of the safety and efficacy of using human menstrual blood‐derived mesenchymal stromal cells in treating severe and critically ill COVID‐19 patients: An exploratory clinical trial

중증 및 중환자 COVID-19 환자 치료에서 인간 월경혈유래 중간엽 기질 세포의 안전성 및 효능 평가: 탐색적 임상 시험

Clinical Trial

Published on 2021-01-272022-08-13
Journal: Clinical and Translational Medicine [Category] MERS, 임상,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adverse event adverse events AEs Allogeneic alternative method caused chest imaging clinical trial Concomitant medication concomitant medications control group coronavirus coronavirus disease Coronavirus disease 2019 coronavirus disease 2019 (COVID‐19) COVID‐19 COVID‐19 patients Critical Critically ill died Dyspnea effective Efficacy enrolled experimental group exploratory Frequency groups incidence lack menstrual Mesenchymal stromal cell Mesenchymal stromal cells Mortality MSC MSC therapy MSCs multicenter nonrandomized not differ open‐label Patient patients problems proliferation respiratory Safety safety and efficacy SARS‐CoV‐2 secondary endpoint Secondary endpoints severe acute respiratory syndrome Coronavirus severe and critical patients significantly significantly lower Spread stromal cell stromal cells therapy treat treated Treatment Trial was measured were assessed
[DOI] 10.1002/ctm2.297 PMC 바로가기 [Article Type] Clinical Trial

Hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting (LIBERTY): A structured summary of a study protocol for a randomised controlled trial

일차 진료 환경(LIBERTY)에서 Covid-19 감염 성인 환자 치료에 사용되는 하이드록시클로로퀸: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-01-112022-09-10
Journal: Trials [Category] MERS, 임상,

[키워드] 1:1 addition addressed administration Adult patients adverse event adverse events AEs age all-cause hospitalization Antibody Response Anxiety Anxiety Disorder ARMS association Biomarker blinded Blinding Blood BMI capture Care changes changes in Characteristics clinical trial concentrations concomitant medications conducted Contact Course COVID-19 COVID-19 infection COVID-19-related symptoms criteria death deleting Demographic variables diabetes Diabetes Mellitus disease dissemination double-blind Effect element enrolment enzyme EudraCT evaluate exclusion expected exploratory exploratory endpoint Exploratory endpoints female Formulation GAD-7 Generalized Generalized Anxiety Disorder Genetic variation HCQ Health care HLA haplotypes hospital Hospitalization hospitalizations Hydroxychloroquine Hypothesis identify include Inclusion independent individual Infection information intensive care unit lactation masking mental health Meta-analysis Mortality Nasopharyngeal swab nasopharyngeal swab sample Nasopharyngeal swab samples number number of deaths objective onset of symptom open care outcome Outpatient outpatients parallel-group participant Patient patient data PCR test PCR testing PCR-confirmed Placebo placebo-controlled post-hoc predict Pregnancy presenting primary care primary endpoint protocol public health public health care randomised randomised controlled trial randomization list Randomized Randomly receive recruitment reduce Registered Regulation repeated reported respiratory respiratory distress respiratory rate response risk room air SAEs Sample size SARS-CoV-2 SARS-CoV-2 PCR test SARS-CoV-2 viral shedding Satakunta secondary endpoint Secondary endpoints Secondary objectives serious AE serum Seven severe pneumonia severity specific treatment status study participant Study participants study population Study protocol subgroup analysis subject supplementary material Suspected Symptom Symptoms technology test result therapeutic potential Tolerability treated Treatment treatment allocation treatment arm Trial Trial registration twice a day type 1 or type 2 Uppsala variable Viral was performed website Well-being
[DOI] 10.1186/s13063-020-04989-6 PMC 바로가기 [Article Type] Letter

Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial

COVID-19(COVID-AT)로 인한 급성 호흡 곤란 증후군 환자에서 동종 간엽 기질 세포의 효능을 평가하기 위한 이중 맹검, 무작위, 대조 시험: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Letter

Published on 2021-01-062022-09-10
Journal: Trials [Category] MERS, 바이오마커, 임상, 치료제,

[키워드] 1:1 24 hours 7-point ordinal scale acute respiratory distress acute respiratory distress syndrome Administered administration Admission Adult patient Adult patients Adverse Adverse drug reactions AEs age All trial participants all-cause mortality allergy Allogeneic ARDS assessment assigned baseline Biomarker blinded Blinding C-reactive protein carcinoma carcinoma in situ carried cellular chain change childbearing potential Chloroquine Clinical practice clinical status clinical trial coagulation test coagulation tests conducted Control control arm Course COVID COVID-19 CRF criteria CT scan cumulative incidence current Cytokines D-dimer Day death described determined by Diagnosis disease dissemination double-blind drug Duration ECMO Efficacy Efficacy and safety element eligible End endpoints enrolment EudraCT evaluate evaluate the effect event exclusion criteria Extracorporeal extracorporeal membrane oxygenation failure ferritin fibrosis FiO2 form GRADE grade 3 greater Haemodialysis handling hemofiltration history hospital Hospitalization hydroxy ICU ICU admission IMPROVE include inclusion criteria Informed consent intravenous Intravenous administration intravenous dose intubation Invasive mechanical ventilation invasive ventilation investigational medicinal product involved laboratory confirmation laboratory-confirmed SARS-CoV-2 infection lactation LDH less Level Local Lopinavir Lopinavir/ritonavir lung disorder lymphocyte marker Mechanical mechanical ventilation Medicine Medicines Mesenchymal stromal cells moderate to severe Mortality MSC negative pregnancy test neoplasm neutrophil neutrophil counts Non-invasive number objective occur off-label opinion Ordinal Scale organ oropharyngeal swab oropharyngeal swabs Other outcome oxygen oxygen saturation Oxygen therapy PaO2 PaO2/FiO2 ratio parameters participant Patient PCR percentage Placebo polymerase chain reaction Pregnancy primary endpoint product Production profile progression protocol Pulmonary embolism pulmonary fibrosis Pulmonary function tests randomised randomised controlled trial randomization Randomized Randomly Rapid antigen tests reaction receive recruitment Registered Remdesivir report respiratory Respiratory distress syndrome Resuscitation Ritonavir SAEs Sample size SARS-COV-2 infection secondary Secondary endpoints Sequential Organ Failure Assessment Serious Adverse Events SOFA Spain specificity specimen Sponsor Standard of care status stromal cell stromal cells Study protocol subpopulations supplemental oxygen supplementary material syndrome the cell the disease the patient the primary endpoint the WHO time Tocilizumab Tolerability Treatment treatment arm treatment for COVID-19 treatment group Treatment protocol Trial trial participant Trial registration unit website women worldwide pandemic written consent
[DOI] 10.1186/s13063-020-04964-1 PMC 바로가기 [Article Type] Letter

Impact of COVID-19 Outbreak through Telemedicine Implementation on Data Reporting During Oncology Clinical Trials

Article

Published on 2021-01-012023-07-13
Journal: Cancer investigation [Category] SARS,

[키워드] COVID19 Oncology clinical trials primary endpoint Secondary endpoints Telemedicine
[DOI] 10.1080/07357907.2020.1858311

Remote continuous glucose monitoring during the COVID-19 pandemic in quarantined hospitalized patients in Denmark: A structured summary of a study protocol for a randomized controlled trial

덴마크의 격리된 입원 환자에서 COVID-19 전염병 동안 원격 연속 혈당 모니터링: 무작위 대조 시험을 위한 연구 프로토콜의 구조화된 요약

Randomized Controlled Trial

Published on 2020-11-252022-09-01
Journal: Trials [Category] SARS, 임상, 진단, 치료기술,

[키워드] 1:1 able to communicate addition Admission age Analysis association band-aid blinded blood glucose blood glucose monitoring calibrated Care CGM Clinical outcome clinically Confirmed COVID-19 infection Contact contagious disease contagious diseases contagious infection contagious infections Controlled trial COVID-19 COVID-19 infected patient COVID-19 infection COVID-19 pandemic Date defined detect diabete diabetes diabetes - diabetes management Diagnosis Diagnostic Criteria dissemination distribution element Endpoint enrolled exclusion criteria exploratory female Finger prick form Glucose glucose control glycaemic control group groups Healthcare provider Hospitalization Hospitalized hospitalized patient hypersensitivity Hypothesis Identifier Improved In-hospital Inclusion inclusion criteria increased risk infected patients Infection infections Informed consent management masking MONITOR mounted must Non-COVID-19 not need number objective open open label outcome parallel group participant Patient patients with diabete performed Pneumonia PPE primary endpoint protocol quarantine randomisation randomised randomised controlled trial randomization randomization list Randomized Randomized controlled trial Real-time PCR recorded reduce remote reported required risk Sample size SARS-COV-2 infection secondary Secondary endpoints service stratified Study protocol subject supplementary material the patient the primary endpoint transmitted Trial trial protocol Trial registration Type 1 diabetes type 2 diabetes variable website World Health Organization written Informed Consent
[DOI] 10.1186/s13063-020-04872-4 PMC 바로가기 [Article Type] Randomized Controlled Trial

COVID-19 in kidney transplant recipients: A multicenter experience in Istanbul

신장 이식 환자의 COVID-19: 이스탄불의 다기관 경험

Multicenter Study

Published on 2020-10-012022-09-11
Journal: Transplant infectious disease : an official journa [Category] MERS, SARS, 진단, 치료제,

[키워드] acute kidney Acute kidney injury Admission Adult all-cause mortality Analysis Antiviral Antiviral agents average Consensus COVID-19 cyclosporine cyclosporine A cytokine cytokine release Cytokine release syndrome cytokine-targeted therapy diagnosed with COVID-19 distress Dyspnea Fever FIVE Follow-up follow-up period Frequency Hospital stay Immunosuppression include induction Infection intensive care intensive care unit İstanbul kidney kidney transplant kidney transplant recipient kidney transplant recipients Kidney transplantation material mechanical ventilation moderate multicenter pandemic Patient patients patients died Pneumonia primary endpoint recipient reduced Regulation rejection respiratory distress Respiratory distress syndrome retrospective cohort study secondary endpoint Secondary endpoints severe pneumonia significantly higher supportive therapy Symptom syndrome targeted therapy the patient therapy Treatment Turkey
[DOI] 10.1111/tid.13371 PMC 바로가기 [Article Type] Multicenter Study

Time to adapt in the pandemic era: a prospective randomized non –inferiority study comparing time to intubate with and without the barrier box

대유행 시대에 적응할 시간: 장벽 상자가 있는 경우와 없는 경우 삽관하는 시간을 비교한 전향적 무작위 비열등성 연구

Research Article

Published on 2020-09-142022-08-09
Journal: BMC Anesthesiology [Category] 임상,

[키워드] 95% CI aerosol aerosol spread Aerosols Airway management in COVID patients airway management practices airway manipulation anesthesiologist anesthesiologists bag-mask ventilation Barrier box barrier boxe barrier boxes both groups clinically comparable confirmation COVID-19 disease defined determine Device disease elective surgeries end-tidal Endpoint enrolled full PPE’ full PPE’s glidescope group Hypothesis in both groups include Intubated intubation less limit loss of twitche loss of twitches lowest oxygen saturation Mean TTI modify Nerve stimulator non-inferiority controlled trial non-inferiority margin normal airway exam null hypothesis number of attempt oxygen oxygen saturation pandemic parameter Patient performed peripheral nerve peripheral nerve stimulator primary measured endpoint raise Randomized Randomly Registered rescue breaths Result secondary Secondary endpoints significant delay spread of COVID-19 study group t-test the mean the study group time time to intubate unpaired two-sample single-sided t-test Usage was used well-trained providers
[DOI] 10.1186/s12871-020-01149-w PMC 바로가기 [Article Type] Research Article