Seq Labeling Tasks
Collection
PICO stands for the framework is used in evidence-based medicine to frame and answer a clinical question.
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Title : Psychosocial behaviour management programme for home - dwelling people with dementia : A cluster - randomized controlled trial . Little is known about the effectiveness of a psychosocial behaviour management programme on home - dwelling people with dementia . We developed a Behaviour Analytics & Support Enhancement ( BASE ) programme for care managers and professional caregivers of home care services in Japan . We investigated the effects of BASE on challenging behaviour of home - dwelling people with dementia . METHODS : A cluster - randomized controlled trial was conducted with home care providers from 3 different districts in Tokyo . Each provider recruited persons with dementia aged 65 years or older to receive home care in the BASE programme in August 2016 . An online monitoring and assessment system was introduced to the intervention group for repeated measures of challenging behaviour with a total score of the Neuropsychiatric Inventory . Care professionals in both the intervention and control groups evaluated challenging behaviour of persons with dementia at baseline ( September 2016 ) and follow - up ( February 2017 ) .
|
{
"P": [
"home - dwelling people with dementia",
"persons with dementia aged 65 years or older to receive home care in the BASE programme in August 2016"
],
"I": [
"Psychosocial behaviour management programme"
],
"C": [],
"O": [
"An online monitoring",
"assessment system",
"challenging behaviour",
"a total score of the Neuropsychiatric Inventory"
]
}
|
Title : Rationale and design for the study of rivaroxaban to reduce thrombotic events , hospitalization and death in outpatients with COVID - 19 : The PREVENT - HD study . METHODS : PREVENT - HD is a double - blind , placebo - controlled , pragmatic , event - driven phase 3 trial to evaluate the efficacy and safety of rivaroxaban in symptomatic outpatients with laboratory - confirmed COVID - 19 at risk for thrombotic events , hospitalization , and death . Several challenges posed by the pandemic have necessitated innovative approaches to clinical trial design , start - up , and conduct . Participants are randomized in a 1 : 1 ratio , stratified by time from COVID - 19 confirmation , to either rivaroxaban 10 mg once daily or placebo for 35 days . The primary efficacy end point is a composite of symptomatic venous thromboembolism , myocardial infarction , ischemic stroke , acute limb ischemia , non - central nervous system systemic embolization , all - cause hospitalization , and all - cause mortality . The primary safety end point is fatal and critical site bleeding according to the International Society on Thrombosis and Haemostasis definition . Enrollment began in August 2020 and is expected to enroll approximately 4 , 000 participants to yield the required number of end point events .
|
{
"P": [
"outpatients with COVID - 19",
"symptomatic outpatients with laboratory - confirmed COVID - 19 at risk for thrombotic events , hospitalization , and death"
],
"I": [
"rivaroxaban"
],
"C": [
"placebo"
],
"O": [
"a composite of symptomatic venous thromboembolism",
"myocardial infarction",
"ischemic stroke",
"acute limb ischemia",
"non - central nervous system systemic embolization",
"all - cause hospitalization",
"all - cause mortality",
"fatal",
"critical site bleeding",
"the International Society on Thrombosis and Haemostasis definition"
]
}
|
Title : Long - Lasting Neuropsychological Effects of a Computerized Cognitive Training in Patients Affected by Early Stage Alzheimer ' s Disease : Are They Stable Over Time ? . METHODS : Eighty AD patients were randomized in two groups and underwent a computerized cognitive training , or a control intervention .
|
{
"P": [
"Patients Affected by Early Stage Alzheimer ' s Disease",
"Eighty AD patients"
],
"I": [
"a Computerized Cognitive Training",
"a computerized cognitive training"
],
"C": [],
"O": []
}
|
Title : Risperidone in the treatment of psychosis of Alzheimer disease : results from a prospective clinical trial . METHODS : The authors conducted a randomized , eight - week , double - blind , placebo - controlled , multicenter trial involving nursing home residents diagnosed with AD and psychosis . Four hundred seventy - three patients were randomly assigned to placebo ( N = 238 ) or 1 . 0 to 1 . 5 mg risperidone per day ( N = 235 ) . Coprimary efficacy end points were : changes in scores on the Behavioral pathology in Alzheimer ' s Disease ( BEHAVE - AD ) Psychosis subscale and Clinical Global Impression of Change ( CGI - C ) . Protocol - specified subgroup analyses were performed by demographics and dementia severity .
|
{
"P": [
"nursing home residents diagnosed with AD and psychosis",
"Four hundred seventy - three patients"
],
"I": [
"Risperidone",
"1 . 0 to 1 . 5 mg risperidone"
],
"C": [
"placebo"
],
"O": [
"the Behavioral pathology in Alzheimer ' s Disease ( BEHAVE - AD ) Psychosis subscale",
"Clinical Global Impression of Change ( CGI - C )"
]
}
|
Title : Key lessons learned from short - term treatment trials of cholinesterase inhibitors for amnestic MCI . METHODS : The study was a 24 - week placebo - controlled trial designed to evaluate the efficacy and safety of donepezil HCl ( donepezil ) in the treatment of cognitive impairment in subjects with MCI . Primary outcome measures were the NYU Paragraphs Test and the ADCS Clinicians Global - Impression of Change in the intent - to - treat last - observation - carried - forward group .
|
{
"P": [
"subjects with MCI"
],
"I": [
"cholinesterase inhibitors",
"donepezil HCl ( donepezil )"
],
"C": [],
"O": [
"the NYU Paragraphs Test",
"the ADCS Clinicians Global - Impression of Change"
]
}
|
Title : A randomized , double - blind , placebo - controlled , 16 - week study of the H3 receptor antagonist , GSK239512 as a monotherapy in subjects with mild - to - moderate Alzheimer ' s disease . METHODS : In this 16 - week , double - blind , randomized , parallel group study , 196 currently untreated subjects with mild - tomoderate AD ( Mini Mental State Examination [ MMSE ] 16 - 24 ) received GSK239512 ( n=97 ) ; or placebo ( n=99 ) administered orally each morning . After a two - week placebo run - in period GSK239512 was up - titrated over 4 weeks in a flexible manner ( 10-20-40 - 80 microgram [ g ] ) followed by a 12 - week Maintenance Phase . Co - primary efficacy endpoints were change from baseline in Episodic Memory and Executive Function / Working Memory composite scores from the CogState neuropsychological test battery ( NTB ) at Week 16 .
|
{
"P": [
"subjects with mild - to - moderate Alzheimer ' s disease",
"196 currently untreated subjects with mild - tomoderate AD ( Mini Mental State Examination [ MMSE ] 16 - 24 )"
],
"I": [
"the H3 receptor antagonist",
"GSK239512"
],
"C": [
"placebo"
],
"O": [
"Episodic Memory",
"Executive Function",
"Working Memory composite scores",
"the CogState neuropsychological test battery ( NTB )"
]
}
|
Title : Evaluating the effects of Intravenous Immunoglobulin ( IVIg ) on the management of severe COVID - 19 cases : A randomized controlled trial . METHODS : In this randomized controlled trial , 84 patients were included : 52 in the IVIg group and 32 in the control group . The intervention group received IVIg at a dose of 400 mg / kg , IV , daily for three days . Both groups received hydroxychloroquine , lopinavir / ritonavir and supportive care . The demographic data , mortality rate , the need for mechanical ventilation , length of stay in hospital and in Intensive Care Unit ( ICU ) , and imaging findings were recorded and compared in terms of the mentioned factors .
|
{
"P": [
"84 patients"
],
"I": [
"Intravenous Immunoglobulin ( IVIg )",
"the IVIg",
"IVIg",
"hydroxychloroquine",
"lopinavir",
"ritonavir",
"supportive care"
],
"C": [],
"O": [
"The demographic data",
"mortality rate",
"the need for mechanical ventilation",
"length of stay in hospital",
"in Intensive Care Unit ( ICU )",
"imaging findings"
]
}
|
Title : Response of patients with Alzheimer disease to rivastigmine treatment is predicted by the rate of disease progression . METHODS : A 26 - week , open - label extension study following a 26 - week , double - blind , randomized , placebo - controlled trial . Outpatient research centers at 22 sites in the United States . We studied 187 of 235 patients originally randomized to receive placebo treatment in the double - blind phase of the trial who continued with open - label ( rivastigmine ) extension therapy . Placebo treatment for 26 weeks followed by rivastigmine treatment , 2 to 12 mg / d , for 26 weeks . Alzheimer ' s Disease Assessment Scale - cognitive subscale ( ADAS - Cog ) , Progressive Deterioration Scale , Mini - Mental State Examination , and Global Deterioration Scale scores .
|
{
"P": [
"patients with Alzheimer disease",
"187 of 235 patients"
],
"I": [
"rivastigmine treatment",
"rivastigmine"
],
"C": [
"placebo treatment",
"Placebo treatment"
],
"O": [
"Alzheimer ' s Disease Assessment Scale - cognitive subscale ( ADAS - Cog )",
"Progressive Deterioration Scale",
"Mini - Mental State Examination",
"Global Deterioration Scale scores"
]
}
|
Title : Clinical effects of Abeta immunization ( AN1792 ) in patients with AD in an interrupted trial . METHODS : This randomized , multicenter , placebo - controlled , double - blind trial of IM AN1792 225 microg plus the adjuvant QS - 21 50 microg ( 300 patients ) and saline ( 72 patients ) included patients aged 50 to 85 years with probable AD , Mini - Mental State Examination ( MMSE ) 15 to 26 . Injections were planned for months 0 , 1 , 3 , 6 , 9 , and 12 . Safety and tolerability were evaluated , and pilot efficacy ( AD Assessment Scale - Cognitive Subscale [ ADAS - Cog ] , MRI , neuropsychological test battery [ NTB ] , CSF tau , and Abeta42 ) was assessed in anti - AN1792 antibody responder patients ( immunoglobulin G titer > or = 1 : 2 , 200 ) .
|
{
"P": [
"patients with AD",
"patients aged 50 to 85 years with probable AD , Mini - Mental State Examination ( MMSE ) 15 to 26"
],
"I": [
"Abeta immunization ( AN1792 )",
"IM AN1792",
"the adjuvant QS - 21"
],
"C": [
"saline"
],
"O": [
"pilot efficacy",
"AD Assessment Scale - Cognitive Subscale [ ADAS - Cog ]",
"MRI",
"neuropsychological test battery [ NTB ]",
"CSF tau",
"Abeta42"
]
}
|
Title : A phase III randomized trial of gantenerumab in prodromal Alzheimer ' s disease . METHODS : In this randomized , double - blind , placebo - controlled phase III study , we investigated gantenerumab over 2 years . Patients were randomized to gantenerumab 105 mg or 225 mg or placebo every 4 weeks by subcutaneous injection . The primary endpoint was the change from baseline to week 104 in Clinical Dementia Rating Sum of Boxes ( CDR - SB ) score . We evaluated treatment effects on cerebrospinal fluid biomarkers ( all patients ) and amyloid positron emission tomography ( substudy ) . A futility analysis was performed once 50 % of patients completed 2 years of treatment . Safety was assessed in patients who received at least one dose .
|
{
"P": [],
"I": [
"gantenerumab"
],
"C": [
"placebo"
],
"O": [
"Clinical Dementia Rating Sum of Boxes ( CDR - SB ) score",
"cerebrospinal fluid biomarkers",
"amyloid positron emission tomography"
]
}
|
Title : The impact of sofosbuvir / daclatasvir or ribavirin in patients with severe COVID - 19 . METHODS : Patients with a positive nasopharyngeal swab for SARS - CoV - 2 on RT - PCR or bilateral multi - lobar ground - glass opacity on their chest CT and signs of severe COVID - 19 were included . Subjects were divided into two arms with one arm receiving ribavirin and the other receiving sofosbuvir / daclatasvir . All participants also received the recommended national standard treatment which , at that time , was lopinavir / ritonavir and single - dose hydroxychloroquine . The primary endpoint was time from starting the medication until discharge from hospital with secondary endpoints of duration of ICU stay and mortality .
|
{
"P": [
"patients with severe COVID - 19",
"Patients with a positive nasopharyngeal swab for SARS - CoV - 2 on RT - PCR or bilateral multi - lobar ground - glass opacity on their chest CT and signs of severe COVID - 19"
],
"I": [
"sofosbuvir",
"daclatasvir",
"ribavirin",
"the recommended national standard treatment",
"lopinavir",
"ritonavir",
"single - dose hydroxychloroquine"
],
"C": [],
"O": [
"time from starting the medication until discharge from hospital",
"duration of ICU stay",
"mortality"
]
}
|
Title : Rivastigmine transdermal patch and physical exercises for Alzheimer ' s disease : a randomized clinical trial . METHODS : A randomized , controlled , single - blinded trial was conducted in 40 patients with mild to moderate stages of AD . All patients were daily treated with rivastigmine transdermal patch at a stable dose of 4 . 6 mg and randomized into two groups : physical exercises or control . The exercise program consisted of aerobic , flexibility , strength and balance movements , twice a week for 6 months . Main outcomes were Quality of Life in Alzheimer ' s disease scale ( QOL ) , Activities of Daily Living Questionnaire ( ADL ) , Mini - Mental State Examination ( MMSE ) and " Time Up and Go Test " .
|
{
"P": [
"40 patients with mild to moderate stages of AD"
],
"I": [
"Rivastigmine transdermal patch",
"physical exercises",
"rivastigmine transdermal patch",
"The exercise program",
"aerobic",
"flexibility",
"strength",
"balance movements"
],
"C": [],
"O": [
"Quality of Life in Alzheimer ' s disease scale ( QOL )",
"Activities of Daily Living Questionnaire ( ADL )",
"Mini - Mental State Examination ( MMSE )",
"\" Time Up and Go Test \""
]
}
|
Title : Effects of Physical Activity in Nursing Home Residents with Dementia : A Randomized Controlled Trial . METHODS : Eighty - seven nursing home residents with dementia were randomly assigned to 3 physical activity interventions : activities of daily living ( ADL ) training , multicomponent exercise training , or combined multicomponent exercise and ADL training . Outcomes were measured at baseline , and after 3 and 6 months .
|
{
"P": [
"Nursing Home Residents with Dementia",
"Eighty - seven nursing home residents with dementia"
],
"I": [
"Physical Activity",
"3 physical activity interventions",
"activities of daily living ( ADL ) training",
"multicomponent exercise training",
"combined multicomponent exercise",
"ADL training"
],
"C": [],
"O": []
}
|
Title : Assessing the efficacy and safety of hydroxychloroquine as outpatient treatment of COVID - 19 : a randomized controlled trial . METHODS : This randomized controlled trial was conducted in Alberta during the first wave of the COVID - 19 pandemic without direct contact with participants . Community - dwelling individuals with confirmed SARS - CoV - 2 infection ( by reverse transcription polymerase chain reaction [ RT - PCR ] viral ribonucleic acid test ) within the previous 4 days , and symptom onset within the previous 12 days , were randomly assigned to oral hydroxychloroquine or matching placebo for 5 days . Enrolment began Apr . 15 , 2020 . The primary outcome was the composite of hospitalization , invasive mechanical ventilation or death within 30 days . Secondary outcomes included symptom duration and disposition at 30 days . Safety outcomes , such as serious adverse events and mortality , were also ascertained . Outcomes were determined by telephone follow - up and administrative data .
|
{
"P": [
"Community - dwelling individuals with confirmed SARS - CoV - 2 infection ( by reverse transcription polymerase chain reaction [ RT - PCR ] viral ribonucleic acid test ) within the previous 4 days , and symptom onset within the previous 12 days"
],
"I": [
"hydroxychloroquine",
"oral hydroxychloroquine"
],
"C": [
"matching placebo"
],
"O": [
"the composite of hospitalization",
"invasive mechanical ventilation",
"death",
"symptom duration",
"disposition",
"Safety outcomes",
"serious adverse events",
"mortality"
]
}
|
Title : Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID - 19 and elevated D - dimer concentration ( ACTION ) : an open - label , multicentre , randomised , controlled trial . METHODS : We did a pragmatic , open - label ( with blinded adjudication ) , multicentre , randomised , controlled trial , at 31 sites in Brazil . Patients ( aged ?18 years ) hospitalised with COVID - 19 and elevated D - dimer concentration , and who had COVID - 19 symptoms for up to 14 days before randomisation , were randomly assigned ( 1 : 1 ) to receive either therapeutic or prophylactic anticoagulation . Therapeutic anticoagulation was in - hospital oral rivaroxaban ( 20 mg or 15 mg daily ) for stable patients , or initial subcutaneous enoxaparin ( 1 mg / kg twice per day ) or intravenous unfractionated heparin ( to achieve a 03 - 07 IU / mL anti - Xa concentration ) for clinically unstable patients , followed by rivaroxaban to day 30 . Prophylactic anticoagulation was standard in - hospital enoxaparin or unfractionated heparin . The primary efficacy outcome was a hierarchical analysis of time to death , duration of hospitalisation , or duration of supplemental oxygen to day 30 , analysed with the win ratio method ( a ratio > 1 reflects a better outcome in the therapeutic anticoagulation group ) in the intention - to - treat population . The primary safety outcome was major or clinically relevant non - major bleeding through 30 days . This study is registered with ClinicalTrials . gov ( NCT04394377 ) and is completed .
|
{
"P": [
"patients admitted to hospital with COVID - 19 and elevated D - dimer concentration",
"Patients ( aged ?18 years ) hospitalised with COVID - 19 and elevated D - dimer concentration , and who had COVID - 19 symptoms for up to 14 days before randomisation"
],
"I": [
"Therapeutic",
"therapeutic",
"Therapeutic anticoagulation",
"in - hospital oral rivaroxaban",
"initial subcutaneous enoxaparin",
"intravenous unfractionated heparin",
"rivaroxaban"
],
"C": [
"prophylactic anticoagulation",
"Prophylactic anticoagulation",
"standard in - hospital enoxaparin",
"unfractionated heparin"
],
"O": [
"time to death",
"duration of hospitalisation",
"duration of supplemental oxygen",
"major",
"clinically relevant non - major bleeding"
]
}
|
Title : Spine Surgery under general anesthesia may not increase the risk of Alzheimer ' s disease . METHODS : We searched the Clinical Data Repository of the University of Virginia for patients receiving spine surgery from January 1 , 1992 to March 1 , 2004 . Patients with newly - diagnosed AD after the surgery but before March 1 , 2009 ( a minimal 5 - year follow - up time after the surgery ) were identified .
|
{
"P": [
"patients receiving spine surgery from January 1 , 1992 to March 1 , 2004",
"Patients with newly - diagnosed AD after the surgery but before March 1 , 2009 ( a minimal 5 - year follow - up time after the surgery )"
],
"I": [
"Spine Surgery",
"general anesthesia"
],
"C": [],
"O": []
}
|
Title : Traditional Chinese medicine shenhuang granule in patients with severe / critical COVID - 19 : A randomized controlled multicenter trial . METHODS : This was an open - label , multicenter , randomized , controlled clinical trial . At 4 medical centers , a total of 111 severe / critical patients were randomly assigned to receive Shenhuang Granule ( SHG group ) twice a day for 14 days , in addition to standard care , or to receive standard care alone ( Control group ) . The maximal follow up time was 75 days . The clinical endpoint was clinical improvement and mortality .
|
{
"P": [
"patients with severe / critical COVID - 19",
"a total of 111 severe / critical patients"
],
"I": [
"Traditional Chinese medicine shenhuang granule",
"Shenhuang Granule",
"SHG",
"standard care"
],
"C": [
"standard care alone"
],
"O": []
}
|
Title : Efficacy of galantamine in probable vascular dementia and Alzheimer ' s disease combined with cerebrovascular disease : a randomised trial . METHODS : Eligible patients were randomly assigned galantamine 24 mg / day ( n=396 ) or placebo ( n=196 ) in a multicentre , double - blind , 6 - month trial . Primary endpoints were cognition ( Alzheimer ' s disease assessment scale , cognitive subscale [ ADAS - cog ] ) and global functioning ( clinician ' s interview - based impression of change plus caregiver input [ CIBIC - plus ] ) . Secondary endpoints included assessments of activities of daily living and behavioural symptoms . Patients were monitored for adverse events . Analyses were on the basis of observed case or last observation carried forward .
|
{
"P": [],
"I": [
"galantamine"
],
"C": [
"placebo"
],
"O": [
"cognition",
"Alzheimer ' s disease assessment scale",
"cognitive subscale [ ADAS - cog ]",
"global functioning",
"clinician ' s interview - based impression of change",
"caregiver input [ CIBIC - plus ]",
"activities of daily living",
"behavioural symptoms",
"adverse events"
]
}
|
Title : Changes in Brain Volume with Bapineuzumab in Mild to Moderate Alzheimer ' s Disease . METHODS : Bapineuzumab dosages included 0 . 5 mg / kg in carriers and 0 . 5 or 1 . 0 mg / kg in noncarriers , every 13 weeks for 78 weeks . Volumetric outcomes included annualized brain , ventricular , and mean hippocampal boundary shift integrals ( BBSI ; VBSI ; HBSI ) up to Week 71 . Treatment differences were estimated using mixed models for repeated measures .
|
{
"P": [],
"I": [
"Bapineuzumab"
],
"C": [],
"O": [
"annualized brain",
"ventricular",
"mean hippocampal boundary shift integrals",
"BBSI",
"VBSI",
"HBSI"
]
}
|
Title : Repurposed Antiviral Drugs for Covid - 19 - Interim WHO Solidarity Trial Results . METHODS : We randomly assigned inpatients with Covid - 19 equally between one of the trial drug regimens that was locally available and open control ( up to five options , four active and the local standard of care ) . The intention - to - treat primary analyses examined in - hospital mortality in the four pairwise comparisons of each trial drug and its control ( drug available but patient assigned to the same care without that drug ) . Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry .
|
{
"P": [
"inpatients with Covid - 19"
],
"I": [
"four active"
],
"C": [
"the local standard of care"
],
"O": [
"in - hospital mortality",
"Rate ratios for death"
]
}
|
Title : Magnesium treatment on methylation changes of transmembrane serine protease 2 ( TMPRSS2 ) . METHODS : This study is nested within the Personalized Prevention of Colorectal Cancer Trial , a double - blind 2 O 2 factorial randomized controlled trial , which enrolled 250 participants from Vanderbilt University Medical Center .
|
{
"P": [
"250 participants from Vanderbilt University Medical Center"
],
"I": [
"Magnesium treatment"
],
"C": [],
"O": []
}
|
Title : Nutritional treatment of aged individuals with Alzheimer disease living at home with their spouses : study protocol for a randomized controlled trial . METHODS : AD patients and their spouses ( aged > 65 years ) living at home ( n = 202 , 102 AD patients ) were recruited using central AD registers in Finland . The couples were randomized into intervention and control groups . A trained nutritionist visited intervention couples 4 - 8 times at their homes and the couples received tailored nutritional care . When necessary , the couples were given protein and nutrient - enriched complementary drinks . All intervention couples were advised to take vitamin D 20 ?g / day . The intervention lasted for one year . The couples of the control group received a written guide on nutrition of older people . Participants in the intervention group were assessed every three months . The primary outcome measure is weight change . Secondary measures are the intake of energy , protein , and other nutrients , nutritional status , cognition , caregiver ' s burden , depression , health related quality of life and grip strength .
|
{
"P": [
"aged individuals with Alzheimer disease living at home with their spouses",
"AD patients and their spouses ( aged > 65 years ) living at home ( n = 202 , 102 AD patients )"
],
"I": [
"Nutritional treatment",
"tailored nutritional care",
"vitamin D"
],
"C": [
"a written guide"
],
"O": [
"weight change",
"the intake of energy",
"protein",
"other nutrients",
"nutritional status",
"cognition",
"caregiver ' s burden",
"depression",
"health related quality of life",
"grip strength"
]
}
|
Title : Ivermectin to prevent hospitalizations in patients with COVID - 19 ( IVERCOR - COVID19 ) a randomized , double - blind , placebo - controlled trial . METHODS : A randomized , double - blind , placebo - controlled study was conducted in non - hospitalized individuals with COVID - 19 in Corrientes , Argentina . Patients with SARS - CoV - 2 positive nasal swabs were contacted within 48 h by telephone to invite them to participate . The trial randomized 501 patients between August 19 th 2020 and February 22 nd 2021 . Patients were randomized to ivermectin ( N = 250 ) or placebo ( N = 251 ) arms in a staggered dose , according to the patient ' s weight , for 2 days . The efficacy of ivermectin to prevent hospitalizations was evaluated as primary outcome . We evaluated secondary outcomes in relationship to safety and other efficacy end points .
|
{
"P": [
"patients with COVID - 19",
"non - hospitalized individuals with COVID - 19 in Corrientes , Argentina",
"Patients with SARS - CoV - 2 positive nasal swabs",
"501 patients between August 19 th 2020 and February 22 nd 2021"
],
"I": [
"Ivermectin",
"ivermectin"
],
"C": [
"placebo"
],
"O": [
"hospitalizations",
"safety"
]
}
|
Title : Efficacy of Brazilian green propolis ( EPP - AF ) as an adjunct treatment for hospitalized COVID - 19 patients : A randomized , controlled clinical trial . METHODS : In a randomized , controlled , open - label , single - center trial , hospitalized adult COVID - 19 patients were treated with a standardized green propolis extract ( EPP - AF? ) as an adjunct therapy . Patients were allocated to receive standard care plus an oral dose of 400 mg or 800 mg / day of green propolis for seven days , or standard care alone . Standard care included all necessary interventions , as determined by the attending physician . The primary end point was the time to clinical improvement , defined as the length of hospital stay or oxygen therapy dependency duration . Secondary outcomes included acute kidney injury and need for intensive care or vasoactive drugs . Patients were followed for 28 days after admission .
|
{
"P": [
"hospitalized COVID - 19 patients",
"hospitalized adult COVID - 19 patients"
],
"I": [
"Brazilian green propolis",
"EPP - AF",
"a standardized green propolis extract",
"EPP - AF?",
"standard care",
"an oral dose of 400 mg",
"800 mg / day of green propolis",
"Standard care"
],
"C": [
"standard care alone"
],
"O": [
"the time to clinical improvement",
"the length of hospital stay",
"oxygen therapy dependency duration",
"acute kidney injury",
"need for intensive care",
"vasoactive drugs"
]
}
|
Title : Effects of a non - focal plasticity protocol on apathy in moderate Alzheimer ' s disease : a randomized , double - blind , sham - controlled trial . METHODS : Forty patients were randomized to receive either active or sham - tDCS over the left dorsolateral prefrontal cortex ( DLPFC ) . Patients received six sessions of intervention during 2 weeks and were evaluated at baseline , at week 1 and 2 , and after 1 week without intervention . Clinical raters , patients , and caregivers were blinded . The primary outcome was apathy . Global cognition and neuropsychiatric symptoms were examined as secondary outcomes .
|
{
"P": [
"Forty patients"
],
"I": [
"a non - focal plasticity protocol",
"active"
],
"C": [
"sham - tDCS"
],
"O": [
"apathy",
"Global cognition",
"neuropsychiatric symptoms"
]
}
|
Title : Effects of a 2 - Week 5000 IU versus 1000 IU Vitamin D3 Supplementation on Recovery of Symptoms in Patients with Mild to Moderate Covid - 19 : A Randomized Clinical Trial . METHODS : A total of 69 reverse transcriptase polymerase chain reaction ( RT - PCR ) SARS - CoV - 2 positive adults who were hospitalized for mild to moderate COVID - 19 disease were allocated to receive once daily for 2 weeks either 5000 IU oral vitamin D3 ( n = 36 , 21 males ; 15 females ) or 1000 IU oral vitamin D3 ( standard control ) ( n = 33 , 13 males ; 20 females ) . Anthropometrics were measured and blood samples were taken pre - and post - supplementation . Fasting blood glucose , lipids , serum 25 ( OH ) D , and inflammatory markers were measured . COVID - 19 symptoms were noted on admission and monitored until full recovery .
|
{
"P": [
"Patients with Mild to Moderate Covid - 19",
"A total of 69 reverse transcriptase polymerase chain reaction ( RT - PCR ) SARS - CoV - 2 positive adults who were hospitalized for mild to moderate COVID - 19 disease"
],
"I": [
"a 2 - Week 5000 IU",
"once daily for 2 weeks either 5000 IU oral vitamin D3"
],
"C": [
"1000 IU Vitamin D3 Supplementation",
"1000 IU oral vitamin D3"
],
"O": [
"Anthropometrics",
"Fasting blood glucose",
"lipids",
"serum 25 ( OH ) D",
"inflammatory markers",
"COVID - 19 symptoms"
]
}
|
Title : What about tocilizumab ? A retrospective study from a NYC Hospital during the COVID - 19 outbreak . METHODS : In this retrospective analysis of patients with COVID - 19 admitted between March 2 and April 14 , 2020 to a large academic medical center in New York City , we describe outcomes associated with tocilizumab 400 mg ( without methylprednisolone ) compared to a propensity - matched control . The primary endpoints were change in a 7 - point ordinal scale of oxygenation and ventilator free survival , both at days 14 and 28 . Secondary endpoints include incidence of bacterial superinfections and gastrointestinal perforation . Primary outcomes were evaluated using t - test .
|
{
"P": [
"patients with COVID - 19 admitted between March 2 and April 14 , 2020 to a large academic medical center in New York City"
],
"I": [
"tocilizumab",
"without methylprednisolone"
],
"C": [
"a propensity - matched"
],
"O": [
"a 7 - point ordinal scale of oxygenation",
"ventilator free survival",
"incidence of bacterial superinfections",
"gastrointestinal perforation"
]
}
|
Title : Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID - 19 : The TOGETHER Randomized Clinical Trial . METHODS : This randomized clinical trial was conducted in Brazil . Recently symptomatic adults diagnosed with respiratory symptoms from SARS - CoV - 2 infection were enrolled between June 2 and September 30 , 2020 . The planned sample size was 1476 patients , with interim analyses planned after 500 patients were enrolled . The trial was stopped after the interim analysis for futility with a sample size of 685 patients . Statistical analysis was performed in December 2020 . Patients were randomly assigned to hydroxychloroquine ( 800 mg loading dose , then 400 mg daily for 9 days ) , lopinavir - ritonavir ( loading dose of 800 mg and 200 mg , respectively , every 12 hours followed by 400 mg and 100 mg , respectively , every 12 hours for the next 9 days ) , or placebo . The primary outcomes were COVID - 19 - associated hospitalization and death assessed at 90 days after randomization . COVID - 19 - associated hospitalization was analyzed with a Cox proportional hazards model . The trial included the following secondary outcomes : all - cause hospitalization , viral clearance , symptom resolution , and adverse events .
|
{
"P": [
"Patients With COVID - 19",
"Recently symptomatic adults diagnosed with respiratory symptoms from SARS - CoV - 2 infection"
],
"I": [
"Early Treatment With Hydroxychloroquine",
"Lopinavir",
"Ritonavir",
"hydroxychloroquine",
"lopinavir",
"ritonavir"
],
"C": [
"placebo"
],
"O": [
"COVID - 19 - associated hospitalization",
"death",
"all - cause hospitalization",
"viral clearance",
"symptom resolution",
"adverse events"
]
}
|
Title : Citalopram for the Treatment of Agitation in Alzheimer Dementia : Genetic Influences . METHODS : We utilized data from the Citalopram for Agitation in Alzheimer ' s Disease ( CitAD ) database . CitAD was a 9 - week randomized , double - blind , placebo - controlled multicenter clinical trial showing significant improvement in agitation and caregiver distress in patients treated with citalopram . Proportional odds logistic regression and mixed effects models were used to examine the above - mentioned outcome measures .
|
{
"P": [],
"I": [
"Citalopram",
"the Citalopram",
"citalopram"
],
"C": [],
"O": []
}
|
Title : Efficacy and safety of Levamisole treatment in clinical presentations of non - hospitalized patients with COVID - 19 : a double - blind , randomized , controlled trial . METHODS : This prospective , double - blind , randomized controlled clinical trial was performed in adult patients with mild to moderate COVID - 19 ( room - air oxygen saturation > 94 % ) from late April 2020 to mid - August 2020 . Patients were randomly assigned to receive a 3 - day course of Levamisole or placebo in combination with routine standard of care .
|
{
"P": [
"non - hospitalized patients with COVID - 19",
"adult patients with mild to moderate COVID - 19 ( room - air oxygen saturation > 94 % ) from late April 2020 to mid - August 2020"
],
"I": [
"Levamisole treatment",
"a 3 - day course of Levamisole",
"routine standard of care"
],
"C": [
"placebo"
],
"O": []
}
|
Title : Methylprednisolone in adults hospitalized with COVID - 19 pneumonia : An open - label randomized trial ( GLUCOCOVID ) . METHODS : The study was a multicentric open - label trial of COVID - 19 patients who were aged ? 18 years , receiving oxygen without mechanical ventilation , and with evidence of systemic inflammatory response who were assigned to standard of care ( SOC ) or SOC plus intravenous MP ( 40 mg bid for 3 days followed by 20 mg bid for 3 days ) . The primary outcome was a composite of death , admission to the intensive care unit , or requirement for noninvasive ventilation . Both intention - to - treat ( ITT ) and per protocol ( PP ) analyses were performed .
|
{
"P": [
"adults hospitalized with COVID - 19 pneumonia",
"COVID - 19 patients who were aged ? 18 years , receiving oxygen without mechanical ventilation , and with evidence of systemic inflammatory response"
],
"I": [
"Methylprednisolone",
"SOC",
"intravenous MP"
],
"C": [
"standard of care ( SOC )"
],
"O": [
"a composite of death",
"admission to the intensive care unit",
"requirement for noninvasive ventilation"
]
}
|
Title : Safety and tolerability of immune globulin intravenous ( human ) , 10 % solution in Japanese subjects with mild to moderate Alzheimer ' s disease . METHODS : Among the 16 subjects , 12 subjects were assigned to the IGIV group and 4 subjects to the placebo group . Subjects received a total of six infusions of either IGIV at a dose of 0 . 2 or 0 . 4 g / kg , or placebo every 2 weeks .
|
{
"P": [
"Japanese subjects with mild to moderate Alzheimer ' s disease",
"the 16 subjects"
],
"I": [
"immune globulin intravenous ( human )",
"the IGIV",
"IGIV"
],
"C": [
"the placebo",
"placebo"
],
"O": []
}
|
Title : Donepezil therapy in clinical practice : a randomized crossover study . METHODS : Two - center , randomized , placebo - controlled , double - masked crossover study . Memory disorders units at Massachusetts General and Brigham and Women ' s hospitals , Boston . Sixty individuals ( 30 men and 30 women ; mean + / - SD age , 75 . 0 + / - 9 . 5 years ) with probable Alzheimer disease and scores of 20 or less on the information - memory - concentration subscale of the Blessed Dementia Scale . Placebo wash - in , followed in randomized sequence by ( 1 ) donepezil hydrochloride therapy , 5 mg / d , for 6 weeks , followed by placebo washout for 6 weeks and ( 2 ) placebo treatment for 6 weeks . Change in Alzheimer ' s Disease Assessment Scale cognitive subscale scores from the beginning to the end of the two 6 - week treatment periods .
|
{
"P": [
"Sixty individuals ( 30 men and 30 women ; mean + / - SD age , 75 . 0 + / - 9 . 5 years ) with probable Alzheimer disease and scores of 20 or less on the information - memory - concentration subscale of the Blessed Dementia Scale"
],
"I": [
"Donepezil therapy",
"donepezil hydrochloride therapy"
],
"C": [
"placebo treatment"
],
"O": [
"Alzheimer ' s Disease Assessment Scale cognitive subscale scores"
]
}
|
Title : [ Observation of therapeutic effect on coronavirus disease 2019 with insomnia in treatment with baduanjin and auricular point sticking therapy ] . METHODS : A total of 90 patients with COVID - 19 accompanied with insomnia were randomly divided into an observation group ( 45 cases , 3 cases dropped off ) and a control group ( 45 cases ) . In the observation group , baduanjin , a traditional Chinese fitness activity , was practiced everyday . Besides , auricular point sticking therapy was exerted at ear - shenmen ( TF 4 ) , subcortex ( AT 4 ) , heart ( CO 15 ) , occiput ( AT 3 ) , etc . These auricular points were pressed and kneaded three times a day , 30 s at each point each time , consecutively for 12 days . In the control group , estazolam tablets were prescribed for oral administration , 1 mg , once daily , consecutively for 12 days . Before and after treatment , the score of Pittsburgh sleep quality index ( PSQI ) , the score of self - rating anxiety scale ( SAS ) , the score of self - rating depression scale ( SDS ) and the score of symptoms in traditional Chinese medicine ( TCM ) were observed in the two groups and the clinical therapeutic effect was evaluated .
|
{
"P": [
"A total of 90 patients with COVID - 19 accompanied with insomnia"
],
"I": [
"baduanjin",
"auricular point sticking therapy",
"a traditional Chinese fitness activity"
],
"C": [
"estazolam"
],
"O": [
"the score of Pittsburgh sleep quality index ( PSQI )",
"the score of self - rating anxiety scale ( SAS )",
"the score of self - rating depression scale ( SDS )",
"the score of symptoms in traditional Chinese medicine ( TCM )"
]
}
|
Title : A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in Coronavirus Disease 2019 Patients With Regular Intravenous Immunoglobulin Therapy . METHODS : An open - label , multicenter , comparative , randomized study was conducted on COVID - 19 patients with moderate pneumonia . One hundred eligible patients were randomized in 1 : 1 ratio either to receive IVIG + standard of care ( SOC ) or SOC .
|
{
"P": [
"Coronavirus Disease 2019 Patients",
"COVID - 19 patients with moderate pneumonia",
"One hundred eligible patients"
],
"I": [
"Regular Intravenous Immunoglobulin Therapy",
"IVIG",
"standard of care ( SOC )"
],
"C": [
"SOC"
],
"O": []
}
|
Title : Tolerability and efficacy of memantine add - on therapy to rivastigmine transdermal patches in mild to moderate Alzheimer ' s disease : a multicenter , randomized , open - label , parallel - group study . METHODS : In this multicenter , randomized , open - label study , patients entered an 8 - week run - in period ( a 5 cm 2 rivastigmine patch for 4 weeks , then a 10 cm ( 2 ) patch for 4 weeks ) followed by 16 weeks of memantine plus rivastigmine patch or rivastigmine patch monotherapy . The primary outcome measure was the retention rate at the end of the trial .
|
{
"P": [],
"I": [
"memantine add - on therapy",
"rivastigmine transdermal patches",
"16 weeks of memantine",
"rivastigmine patch",
"rivastigmine patch monotherapy"
],
"C": [],
"O": [
"the retention rate"
]
}
|
Title : Tocilizumab in Hospitalized Patients with Severe Covid - 19 Pneumonia . METHODS : In this phase 3 trial , we randomly assigned patients who were hospitalized with severe Covid - 19 pneumonia in a 2 : 1 ratio receive a single intravenous infusion of tocilizumab ( at a dose of 8 mg per kilogram of body weight ) or placebo . Approximately one quarter of the participants received a second dose of tocilizumab or placebo 8 to 24 hours after the first dose . The primary outcome was clinical status at day 28 on an ordinal scale ranging from 1 ( discharged or ready for discharge ) to 7 ( death ) in the modified intention - to - treat population , which included all the patients who had received at least one dose of tocilizumab or placebo .
|
{
"P": [
"Hospitalized Patients with Severe Covid - 19 Pneumonia",
"patients who were hospitalized with severe Covid - 19 pneumonia"
],
"I": [
"Tocilizumab",
"a single intravenous infusion of tocilizumab",
"a second dose of tocilizumab",
"one dose of tocilizumab"
],
"C": [
"placebo"
],
"O": [
"clinical status",
"an ordinal scale"
]
}
|
Title : Relationship between pharmacodynamic activity and cognitive effects of eptastigmine in patients with Alzheimer ' s disease . Eptastigmine Study Group . METHODS : This was a double - blind , randomized , placebo - controlled , unbalanced parallel - group study . One - hundred and three patients ( 83 in the eptastigmine group and 20 in the placebo group ) were recruited by 10 centers . Patients received 20 mg eptastigmine or placebo for 4 weeks with twice - a - day or three - times - a - day regimens , depending on body weight ( < or = 65 kg or > 65 kg , respectively ) . Patient performance on the Logical Memory Test , Semantic Word Fluency Test , Trail Making Test , Index of Independence in Activities of Daily Living , Instrumental Activities of Daily Living Scales ( IADL ) , and the Physician and Caregiver Clinical Global Impression of Change ( CGIC ) was assessed at baseline and at the end of treatment .
|
{
"P": [
"patients with Alzheimer ' s disease",
"One - hundred and three patients"
],
"I": [
"eptastigmine",
"the eptastigmine",
"20 mg eptastigmine"
],
"C": [
"the placebo",
"placebo"
],
"O": [
"the Logical Memory Test",
"Semantic Word Fluency Test",
"Trail Making Test",
"Index of Independence in Activities of Daily Living",
"Instrumental Activities of Daily Living Scales ( IADL )",
"the Physician and Caregiver Clinical Global Impression of Change ( CGIC )"
]
}
|
Title : Effects of Folic Acid and Vitamin B12 Supplementation on Cognitive Impairment and Inflammation in Patients with Alzheimer ' s Disease : A Randomized , Single - Blinded , Placebo - Controlled Trial . METHODS : This was a randomized , single - blind , placebo - controlled trial . Patients ( n=120 ) diagnosed clinically as probable AD and in stable condition from Tianjin Key Laboratory of Cerebrovascular and Neurodegenerative Diseases . Individuals were randomly divided into the intervention group ( n=60 , folic acid 1 . 2 mg / d + vitamin B12 50 ?g / d ) and the placebo group ( n=60 ) . Cognitive performance , blood folate , vitamin B12 , one carbon cycle metabolite , and inflammatory cytokine levels were measured at baseline and after 6 months . The data were analyzed using linear mixed models for repeated measures .
|
{
"P": [
"Patients with Alzheimer ' s Disease",
"Patients ( n=120 ) diagnosed clinically as probable AD and in stable condition from Tianjin Key Laboratory of Cerebrovascular and Neurodegenerative Diseases"
],
"I": [
"Folic Acid",
"Vitamin B12 Supplementation",
"folic acid",
"vitamin B12"
],
"C": [
"the placebo"
],
"O": [
"Cognitive performance",
"blood folate",
"vitamin B12",
"one carbon cycle metabolite",
"inflammatory cytokine levels"
]
}
|
Title : Taste - masked and affordable donepezil hydrochloride orally disintegrating tablet as promising solution for non - compliance in Alzheimer ' s disease patients . METHODS : The ODT was manufactured using simple wet - granulation method . Crospovidone XL - 10 was used as superdisintegrant and optimization was done by comparing the effect of three grades of lactose monohydrate compound as filler : Starlac , Flowlac and Tablettose .
|
{
"P": [
"Alzheimer ' s disease patients"
],
"I": [
"Taste - masked and affordable donepezil hydrochloride",
"The ODT",
"three grades of lactose monohydrate compound",
"Starlac",
"Flowlac",
"Tablettose"
],
"C": [],
"O": []
}
|
Title : Respiratory rehabilitation in elderly patients with COVID - 19 : A randomized controlled study . METHODS : This paper reported the findings of an observational , prospective , quasi - experimental study , which totally recruited 72 participants , of which 36 patients underwent respiratory rehabilitation and the rest without any rehabilitation intervention . The following outcomes were measured : pulmonary function tests including plethysmography and diffusing lung capacity for carbon monoxide ( DLCO ) , functional tests ( 6 - min walk distance test ) , Quality of life ( QoL ) assessments ( SF - 36 scores ) , activities of daily living ( Functional Independence Measure , FIM scores ) , and mental status tests ( SAS anxiety and SDS depression scores ) .
|
{
"P": [
"elderly patients with COVID - 19",
"72 participants"
],
"I": [
"Respiratory rehabilitation",
"respiratory rehabilitation"
],
"C": [
"any rehabilitation intervention"
],
"O": [
"pulmonary function tests",
"plethysmography",
"diffusing lung capacity for carbon monoxide ( DLCO )",
"functional tests",
"6 - min walk distance test",
"Quality of life ( QoL ) assessments",
"SF - 36 scores",
"activities of daily living",
"Functional Independence Measure",
"FIM scores",
"mental status tests",
"SAS anxiety",
"SDS depression scores"
]
}
|
Title : Safety and efficacy of methylphenidate for apathy in Alzheimer ' s disease : a randomized , placebo - controlled trial . METHODS : Six - week , randomized , double - blind , placebo - controlled multicenter trial enrolling Alzheimer ' s disease participants ( NINCDS - ADRDA criteria ) with apathy assigned to methylphenidate 20 mg daily or placebo , conducted from June 2010 to December 2011 . Primary outcomes were change in Apathy Evaluation Scale ( AES ) score and modified Alzheimer ' s Disease Cooperative Study - Clinical Global Impression of Change ( ADCS - CGI - C ) . Secondary outcomes included change in Neuropsychiatric Inventory ( NPI ) apathy score , Mini - Mental State Examination ( MMSE ) score , and safety .
|
{
"P": [
"Alzheimer ' s disease participants ( NINCDS - ADRDA criteria ) with apathy"
],
"I": [
"methylphenidate"
],
"C": [
"placebo"
],
"O": [
"Apathy Evaluation Scale ( AES ) score",
"modified Alzheimer ' s Disease Cooperative Study - Clinical Global Impression of Change ( ADCS - CGI - C )",
"Neuropsychiatric Inventory ( NPI ) apathy score",
"Mini - Mental State Examination ( MMSE ) score",
"safety"
]
}
|
Title : Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID - 19 : A Randomized Clinical Trial . METHODS : Double - blind , randomized trial conducted at a single site in Cali , Colombia . Potential study participants were identified by simple random sampling from the state ' s health department electronic database of patients with symptomatic , laboratory - confirmed COVID - 19 during the study period . A total of 476 adult patients with mild disease and symptoms for 7 days or fewer ( at home or hospitalized ) were enrolled between July 15 and November 30 , 2020 , and followed up through December 21 , 2020 . Patients were randomized to receive ivermectin , 300 ?g / kg of body weight per day for 5 days ( n = 200 ) or placebo ( n = 200 ) . Primary outcome was time to resolution of symptoms within a 21 - day follow - up period . Solicited adverse events and serious adverse events were also collected .
|
{
"P": [
"Adults With Mild COVID - 19",
"A total of 476 adult patients with mild disease and symptoms for 7 days or fewer ( at home or hospitalized )"
],
"I": [
"Ivermectin",
"ivermectin"
],
"C": [
"placebo"
],
"O": [
"time to resolution of symptoms",
"Solicited adverse events",
"serious adverse events"
]
}
|
Title : A web - based psychoeducational program for informal caregivers of patients with Alzheimer ' s disease : a pilot randomized controlled trial . METHODS : We recruited and randomized offline 49 informal caregivers of a PWAD in a day care center in Paris , France . They either received the Web - based intervention and usual care for 3 months ( experimental group , n=25 ) or only usual care ( control group , n=24 ) . Caregivers ' perceived stress ( PSS - 14 , primary outcome ) , self - efficacy , burden , perceived health status , and depression ( secondary outcomes ) were measured during 3 face - to - face on - site visits : at baseline , at the end of the program ( month 3 ) , and after follow - up ( month 6 ) . Additionally , semistructured interviews were conducted with experimental group caregivers at month 6 and examined with thematic analysis .
|
{
"P": [
"informal caregivers of patients with Alzheimer ' s disease",
"49 informal caregivers of a PWAD in a day care center in Paris , France"
],
"I": [
"A web - based psychoeducational program",
"the Web - based intervention"
],
"C": [
"usual care",
"only usual care"
],
"O": [
"Caregivers ' perceived stress",
"PSS - 14",
"self - efficacy",
"burden",
"perceived health status",
"depression"
]
}
|
Title : Cognitive effects of treating obstructive sleep apnea in Alzheimer ' s disease : a randomized controlled study . METHODS : Randomized double - blind placebo - controlled trial . Participants were randomized to therapeutic CPAP for 6 weeks or placebo CPAP for 3 weeks followed by therapeutic CPAP for 3 weeks . General clinical research center . Fifty - two men and women with mild to moderate AD and OSA . CPAP . A complete neuropsychological test battery was administered before treatment and at 3 and at 6 weeks .
|
{
"P": [
"Fifty - two men and women with mild to moderate AD and OSA"
],
"I": [
"treating obstructive sleep apnea",
"therapeutic CPAP",
"CPAP"
],
"C": [
"placebo CPAP"
],
"O": [
"A complete neuropsychological test battery"
]
}
|
Title : Effect of Helmet Noninvasive Ventilation vs High - Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID - 19 and Moderate to Severe Hypoxemic Respiratory Failure : The HENIVOT Randomized Clinical Trial . METHODS : Multicenter randomized clinical trial in 4 intensive care units ( ICUs ) in Italy between October and December 2020 , end of follow - up February 11 , 2021 , including 109 patients with COVID - 19 and moderate to severe hypoxemic respiratory failure ( ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ?200 ) . Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation ( positive end - expiratory pressure , 10 - 12 cm H2O ; pressure support , 10 - 12 cm H2O ) for at least 48 hours eventually followed by high - flow nasal oxygen ( n = 54 ) or high - flow oxygen alone ( 60 L / min ) ( n = 55 ) . The primary outcome was the number of days free of respiratory support within 28 days after enrollment . Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment , the number of days free of invasive mechanical ventilation at day 28 , the number of days free of invasive mechanical ventilation at day 60 , in - ICU mortality , in - hospital mortality , 28 - day mortality , 60 - day mortality , ICU length of stay , and hospital length of stay .
|
{
"P": [
"Patients With COVID - 19 and Moderate to Severe Hypoxemic Respiratory Failure",
"109 patients with COVID - 19 and moderate to severe hypoxemic respiratory failure ( ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ?200 )"
],
"I": [
"Helmet Noninvasive Ventilation",
"High - Flow Nasal Oxygen",
"continuous treatment with helmet noninvasive ventilation",
"high - flow nasal oxygen",
"high - flow oxygen alone"
],
"C": [],
"O": [
"the number of days free of respiratory support",
"the proportion of patients who required endotracheal intubation",
"the number of days free of invasive mechanical ventilation",
"in - ICU mortality",
"in - hospital mortality",
"28 - day mortality",
"60 - day mortality",
"ICU length of stay",
"hospital length of stay"
]
}
|
Title : Efficacy and Safety of Citalopram Compared to Atypical Antipsychotics on Agitation in Nursing Home Residents With Alzheimer Dementia . METHODS : Longitudinal , 6 - month study . Nursing home ( NH ) . 75 NH residents with AD and agitation , randomized to citalopram ( n = 25 ) , quetiapine ( n = 25 ) , or olanzapine ( n = 25 ) . Changes in Neuropsychiatric Inventory ( NPI ) agitation subscale score and the modified Alzheimer Disease Cooperative Study - Clinical Global Impression of Change ( mADCS - CGIC ) were used to assess treatment efficacy . Participants were surveilled for adverse health outcomes .
|
{
"P": [
"Nursing Home Residents With Alzheimer Dementia",
"75 NH residents with AD and agitation"
],
"I": [
"Citalopram",
"citalopram",
"quetiapine",
"olanzapine"
],
"C": [
"Atypical Antipsychotics"
],
"O": [
"Neuropsychiatric Inventory ( NPI ) agitation subscale score",
"the modified Alzheimer Disease Cooperative Study - Clinical Global Impression of Change ( mADCS - CGIC )",
"adverse health outcomes"
]
}
|
Title : Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment ( PROTECT ) of Hydroxychloroquine , Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID - 19 infection who have no comorbidities like diabetes mellitus : A structured summary of a study protocol for a randomized controlled trial . METHODS : An adaptive design , set within a comprehensive cohort study , to permit flexibility in this fast - changing clinical and public health scenario . The randomized study will be a multicenter , multiarm , multistage , randomized controlled trial with a parallel design . An observation only cohort will emerge from those not consenting to randomization . Eligible will be newly diagnosed patients , either hospitalized or in self - isolation , without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension . Participants of any gender or age group having tested positive for COVID - 19 on Real - Time qRT - PCR ( Quantitative Reverse Transcription PCR ) will be invited to take part in study at twelve centers across eight cities in Pakistan . Those pregnant or lactating , severely dyspneic or with respiratory distress , already undergoing treatment , and with serious comorbidities like liver or kidney failure will be excluded . METHODS : Participants will be randomized , maintaining concealment of allocation sequence , using a computer - generated random number list of variable block size into multiple intervention groups in the allocation ratio of 1 : 1 for all groups . This is an open label study , neither physician nor participants will be blinded . This is an adaptive design and parameters for formal sample size calculation in a new disease of a previously unknown virus are not available . Thus , the final sample size will be subjected to periodic reviews at each stage of adaptive design and subsequent advice of National Data Safety & Management Board ( NDSMB ) notified by Drug Regulatory Authority of Pakistan . Protocol Version 1 . 7 dated July 5 , 2020 . By July 03 , 2020 , the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan . Recruitment started on April 20 , 2020 . The recruitment is expected to continue for at least three months subject to review by the National Data Safety and Management Board ( NDSMB ) notified by Drug Regulatory Authority of Pakistan .
|
{
"P": [
"newly diagnosed patients with COVID - 19 infection who have no comorbidities like diabetes mellitus",
"newly diagnosed patients , either hospitalized or in self - isolation , without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension"
],
"I": [
"Hydroxychloroquine",
"Oseltamivir",
"Azithromycin"
],
"C": [],
"O": []
}
|
Title : Randomized , placebo - controlled trial of the effects of donepezil on neuronal markers and hippocampal volumes in Alzheimer ' s disease . METHODS : In this randomized , double - blind , placebo - controlled pilot study , 67 patients with mild to moderate Alzheimer ' s disease received 24 weeks of treatment with donepezil ( 5 mg / day for the first 28 days and 10 mg / day thereafter ) or placebo . Patients were reevaluated at 6 - week intervals to measure change from baseline in several outcome measures , including right , left , and total hippocampal volumes , measured with magnetic resonance imaging ; brain concentrations of N - acetylaspartate , measured with proton magnetic resonance spectroscopy ; and cognition , assessed with the Alzheimer ' s Disease Assessment Scale cognitive subscale .
|
{
"P": [
"67 patients with mild to moderate Alzheimer ' s disease"
],
"I": [
"donepezil"
],
"C": [
"placebo"
],
"O": [
"right",
"left",
"total hippocampal volumes",
"magnetic resonance imaging",
"brain concentrations of N - acetylaspartate",
"proton magnetic resonance spectroscopy",
"cognition",
"the Alzheimer ' s Disease Assessment Scale cognitive subscale"
]
}
|
Title : Cost - effectiveness of donepezil and memantine in moderate to severe Alzheimer ' s disease ( the DOMINO - AD trial ) . METHODS : Cost - effectiveness analysis was based on a 52 - week , multicentre , double - blind , placebo - controlled , factorial clinical trial . A total of 295 community - dwelling patients with moderate / severe Alzheimer ' s disease , already treated with donepezil , were randomised to : ( i ) continue donepezil ; ( ii ) discontinue donepezil ; ( iii ) discontinue donepezil and start memantine ; or ( iv ) continue donepezil and start memantine .
|
{
"P": [
"A total of 295 community - dwelling patients with moderate / severe Alzheimer ' s disease"
],
"I": [
"donepezil",
"memantine"
],
"C": [],
"O": []
}
|
Title : Long - term safety and tolerability of atabecestat ( JNJ - 54861911 ) , an oral BACE1 inhibitor , in early Alzheimer ' s disease spectrum patients : a randomized , double - blind , placebo - controlled study and a two - period extension study . METHODS : In the placebo - controlled double - blind parent ALZ2002 study , participants aged 50 to 85 years were randomized ( 1:1:1 ) to placebo or atabecestat 10 or 50 mg once daily ( later reduced to 5 and 25 mg ) for 6 months . Participants entered ALZ2004 , a 12 - month treatment extension with placebo or atabecestat 10 or 25 mg , followed by an open - label phase . Safety , changes in CSF biomarker levels , brain volume , and effects on cognitive performance were assessed .
|
{
"P": [
"early Alzheimer ' s disease spectrum patients",
"participants aged 50 to 85 years"
],
"I": [
"atabecestat ( JNJ - 54861911 )",
"an oral BACE1 inhibitor",
"atabecestat"
],
"C": [
"placebo"
],
"O": [
"Safety",
"CSF biomarker levels",
"brain volume",
"cognitive performance"
]
}
|
Title : Metal - protein attenuation with iodochlorhydroxyquin ( clioquinol ) targeting Abeta amyloid deposition and toxicity in Alzheimer disease : a pilot phase 2 clinical trial . METHODS : A pilot phase 2 clinical trial in patients with moderately severe Alzheimer disease .
|
{
"P": [
"patients with moderately severe Alzheimer disease"
],
"I": [
"iodochlorhydroxyquin ( clioquinol )"
],
"C": [],
"O": []
}
|
Title : Randomised , controlled , open label , multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission , morbidity and mortality in adult patients with COVID - 19 . METHODS : A randomised , controlled , phase II , open label , multicentre trial . 200 subjects with severe COVID - 19 and at least two risk factors for mortality will be included . Baseline clinical data and blood samples will be collected before randomisation and repeated daily for 7 days , at days 14 and 30 . Subjects will be randomised with a computer - based system to HBO , maximum five times during the first 7 days plus best practice treatment or only best practice treatment . The primary endpoint , ICU admission , is defined by criteria for selection for ICU . We will evaluate if HBO mitigates the inflammatory reaction in COVID - 19 using molecular analyses . All parameters are recorded in an electronic case report form . An independent Data Safety Monitoring Board will review the safety parameters .
|
{
"P": [
"adult patients with COVID - 19",
"200 subjects with severe COVID - 19 and at least two risk factors for mortality"
],
"I": [
"hyperbaric oxygen",
"HBO",
"best practice treatment"
],
"C": [
"only best practice treatment"
],
"O": [
"ICU admission",
"criteria for selection for ICU",
"the inflammatory reaction in COVID - 19",
"the safety parameters"
]
}
|
Title : Effect of Hydroxychloroquine in Hospitalized Patients with Covid - 19 . METHODS : In this randomized , controlled , open - label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid - 19 , we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care . The primary outcome was 28 - day mortality .
|
{
"P": [
"Hospitalized Patients with Covid - 19",
"patients hospitalized with Covid - 19"
],
"I": [
"Hydroxychloroquine",
"hydroxychloroquine"
],
"C": [
"usual care"
],
"O": [
"28 - day mortality"
]
}
|
Title : Febuxostat therapy in outpatients with suspected COVID - 19 : A clinical trial . METHODS : We conducted a clinical trial involving adult outpatients with the moderate respiratory illness following COVID - 19 infection . Patients were randomly assigned to receive either FBX or HCQ for 5 days . The measured variables were needs to hospitalisation , clinical and laboratory data including fever , cough , breathing rate , C - Reactive Protein level , lymphocytes count at onset of admission and was well as at 5 days of treatments . In addition , CT findings were evaluated on admission and 14 days after initiation of treatment .
|
{
"P": [
"outpatients with suspected COVID - 19",
"adult outpatients with the moderate respiratory illness following COVID - 19 infection"
],
"I": [
"Febuxostat therapy",
"FBX",
"HCQ"
],
"C": [],
"O": [
"needs to hospitalisation",
"clinical",
"laboratory data",
"fever",
"cough",
"breathing rate",
"C - Reactive Protein level",
"lymphocytes count",
"CT findings"
]
}
|
Title : Dexamethasone vs methylprednisolone high dose for Covid - 19 pneumonia . METHODS : Ambispective cohort study with survival analysis of 216 patients diagnosed with severe Covid - 19 pneumonia confirmed by polymerase chain reaction for SARS - CoV2 by Berlin protocol , who were hospitalized in a high - complexity clinic in Medelln , Colombia . The patients should also have supplementary oxygen and radiological confirmation of Pneumonia by chest tomography . Sample size was not calculated since the total population that met the inclusion criteria was evaluated . 111 patients were treated with the institutional protocol with intravenous dexamethasone 6 mg QD for seven to 10 days if they required oxygen . Since September 15 , 2020 , the hospitalization protocol of the clinic was modified by the Infectious Diseases and Pulmonology service , recommending a high dose of methylprednisolone of 250 to 500 mg every day for three days with a subsequent change to oral prednisone 50 mg every day for 14 days . The protocol was not applied in the intensive care unit , where dexamethasone continued to be administered . The clinical outcome and differences in laboratory results of the patients who received dexamethasone vs . the prospective cohort that received methylprednisolone from September 15 to October 31 , 2020 , were evaluated . Follow - up was carried out by outpatient consultation one month after discharge or by telephone , inquiring about readmission or living - dead status .
|
{
"P": [
"216 patients diagnosed with severe Covid - 19 pneumonia confirmed by polymerase chain reaction for SARS - CoV2 by Berlin protocol , who were hospitalized in a high - complexity clinic in Medelln , Colombia"
],
"I": [
"Dexamethasone",
"methylprednisolone",
"intravenous dexamethasone",
"a high dose of methylprednisolone",
"dexamethasone"
],
"C": [],
"O": [
"The clinical outcome",
"laboratory results",
"readmission",
"living - dead status"
]
}
|
Title : A two - arm , randomized , controlled , multi - centric , open - label phase - 2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID - 19 OBJECTTIVE : Efficacy and safety of Itolizumab , an immunomodulatory mAb , in treating moderate - to - severe acute respiratory distress syndrome ( ARDS ) due to cytokine release in COVID - 19 patients was evaluated in a multi - centric , open - label , two - arm , controlled , randomized , phase - 2 study . METHODS : Patients were randomized ( 2 : 1 ) to Arm - A ( best supportive care [ BSC ] + Itolizumab ) and Arm - B ( BSC ) . Primary outcome of interest was reduction in mortality 30 - days after enrollment .
|
{
"P": [
"moderate to severe ARDS patients due to COVID - 19"
],
"I": [
"Itolizumab",
"best supportive care [ BSC ]"
],
"C": [
"BSC"
],
"O": [
"mortality"
]
}
|
Title : A 1 - year controlled trial of acetyl - l - carnitine in early - onset AD . METHODS : A 1 - year , multicenter , double - blind , placebo - controlled , randomized trial was conducted . Subjects were 45 to 65 years old , with a diagnosis of probable AD according to National Institute of Neurological Communicative Disorders - Alzheimer ' s Disease and Related Disorders Association criteria and had a Mini - Mental State Examination ( MMSE ) score between 12 and 26 . They were treated with ALCAR ( 1 g tid ) or placebo . Primary outcome measures were the Alzheimer ' s Disease Assessment Scale - Cognitive Component and the Clinical Dementia Rating Scale . Secondary measures included the ADAS Non - Cognitive Subscale , the MMSE , an Activities of Daily Living Scale ( ADL ) , and a Clinician - Based Impression of Change ( CIBIC ) .
|
{
"P": [
"45 to 65 years old , with a diagnosis of probable AD according to National Institute of Neurological Communicative Disorders - Alzheimer ' s Disease and Related Disorders Association criteria and had a Mini - Mental State Examination ( MMSE ) score between 12 and 26"
],
"I": [
"acetyl - l - carnitine",
"ALCAR"
],
"C": [
"placebo"
],
"O": [
"the Alzheimer ' s Disease Assessment Scale - Cognitive Component",
"the Clinical Dementia Rating Scale",
"the ADAS Non - Cognitive Subscale",
"the MMSE",
"an Activities of Daily Living Scale ( ADL )",
"a Clinician - Based Impression of Change ( CIBIC )"
]
}
|
Title : Lopinavir - ritonavir in patients admitted to hospital with COVID - 19 ( RECOVERY ) : a randomised , controlled , open - label , platform trial . METHODS : In this randomised , controlled , open - label , platform trial , a range of possible treatments was compared with usual care in patients admitted to hospital with COVID - 19 . The trial is underway at 176 hospitals in the UK . Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus lopinavir - ritonavir ( 400 mg and 100 mg , respectively ) by mouth for 10 days or until discharge ( or one of the other RECOVERY treatment groups : hydroxychloroquine , dexamethasone , or azithromycin ) using web - based simple ( unstratified ) randomisation with allocation concealment . Randomisation to usual care was twice that of any of the active treatment groups ( eg , 2 : 1 in favour of usual care if the patient was eligible for only one active group , 2:1:1 if the patient was eligible for two active groups ) . The primary outcome was 28 - day all - cause mortality . Analyses were done on an intention - to - treat basis in all randomly assigned participants . The trial is registered with ISRCTN , 50189673 , and ClinicalTrials . gov , NCT04381936 .
|
{
"P": [
"patients admitted to hospital with COVID - 19"
],
"I": [
"Lopinavir",
"ritonavir",
"usual standard of care",
"lopinavir",
"hydroxychloroquine",
"dexamethasone",
"azithromycin"
],
"C": [
"usual care",
"usual standard of care alone"
],
"O": [
"28 - day all - cause mortality"
]
}
|
Title : R - and S - citalopram concentrations have differential effects on neuropsychiatric scores in elders with dementia and agitation . METHODS : Citalopram enantiomer exposures ( AUC ( 0 , 24 h ) ) derived from an established population pharmacokinetic analysis were utilized to explore the relationship between ( R ) - and ( S ) - citalopram area under the curve ( AUC ( 0 , 24 ) ) and Mini - Mental State Examination ( MMSE ) , Neurobehavioural Rating Scale - Agitation Subscale ( NBRS - A ) , modified Alzheimer ' s Disease Cooperative Study - Clinical Global Impression of Change ( mADCS - CGIC ) and Neuropsychiatric Inventory Agitation subscale ( NPIA ) scores . Time dependent changes in these scores ( disease progression ) were accounted for prior to exploring the exposure effect relationship for each enantiomer . These relationships were evaluated using a non - linear - mixed effects modelling approach as implemented in nonmem v7 . 3 .
|
{
"P": [
"elders with dementia and agitation"
],
"I": [
"R -",
"S - citalopram",
"Citalopram",
"( R ) -",
"( S ) - citalopram"
],
"C": [],
"O": [
"Mini - Mental State Examination ( MMSE )",
"Neurobehavioural Rating Scale - Agitation Subscale ( NBRS - A )",
"modified Alzheimer ' s Disease Cooperative Study - Clinical Global Impression of Change ( mADCS - CGIC )",
"Neuropsychiatric Inventory Agitation subscale ( NPIA ) scores"
]
}
|
Title : A Phase II study targeting amyloid - beta with 3 APS in mild - to - moderate Alzheimer disease . METHODS : We assessed the safety , tolerability , and pharmacokinetic / pharmacodynamic effect of 3 APS in a randomized , double - blind , placebo - controlled Phase II study in which 58 subjects with mild - to - moderate AD were randomly assigned to receive placebo or 3 APS 50 , 100 , or 150 mg BID for 3 months . At the end of the double - blind phase , 42 of these subjects entered an open - label phase in which they received 3 APS 150 mg BID for 17 months . Assessments included plasma and CSF 3 APS concentrations , CSF levels of Abeta ( Abeta ( 40 ) and Abeta ( 42 ) ) , and total tau , as well as cognitive ( Alzheimer ' s Disease Assessment Scale - cognitive subscale , Mini - Mental State Examination ) and clinical ( Clinical Dementia Rating scale - Sum of Boxes ) measures .
|
{
"P": [
"58 subjects with mild - to - moderate AD"
],
"I": [
"3 APS"
],
"C": [
"placebo"
],
"O": [
"plasma",
"CSF 3 APS concentrations",
"CSF levels of Abeta ( Abeta ( 40 ) and Abeta ( 42 ) )",
"total tau",
"cognitive",
"Alzheimer ' s Disease Assessment Scale - cognitive subscale",
"Mini - Mental State Examination",
"clinical",
"Clinical Dementia Rating scale - Sum of Boxes"
]
}
|
Title : Ruxolitinib in treatment of severe coronavirus disease 2019 ( COVID - 19 ) : A multicenter , single - blind , randomized controlled trial . METHODS : We conducted a prospective , multicenter , single - blind , randomized controlled phase II trial involving patients with severe coronavirus disease 2019 .
|
{
"P": [
"patients with severe coronavirus disease 2019"
],
"I": [
"Ruxolitinib"
],
"C": [],
"O": []
}
|
Title : Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID - 19 - associated cytokine storm syndrome : results of the CHIC study . METHODS : From 1 April 2020 , patients with COVID - 19 - associated CSS , defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations ( C - reactive protein > 100 mg / L ; ferritin > 900 g / L ; D - dimer > 1500 g / L ) , received high - dose intravenous methylprednisolone for 5 consecutive days ( 250 mg on day 1 followed by 80 mg on days 2 - 5 ) . If the respiratory condition had not improved sufficiently ( in 43 % ) , the interleukin - 6 receptor blocker tocilizumab ( 8 mg / kg body weight , single infusion ) was added on or after day 2 . Control patients with COVID - 19 - associated CSS ( same definition ) were retrospectively sampled from the pool of patients ( n=350 ) admitted between 7 March and 31 March , and matched one to one to treated patients on sex and age . The primary outcome was ?2 stages of improvement on a 7 - item WHO - endorsed scale for trials in patients with severe influenza pneumonia , or discharge from the hospital . Secondary outcomes were hospital mortality and mechanical ventilation .
|
{
"P": [
"patients with COVID - 19 - associated cytokine storm syndrome",
"patients with COVID - 19 - associated CSS , defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations ( C - reactive protein > 100 mg / L ; ferritin > 900 g / L ; D - dimer > 1500 g / L )",
"patients with severe influenza pneumonia"
],
"I": [
"glucocorticoids",
"tocilizumab",
"high - dose intravenous methylprednisolone",
"the interleukin - 6 receptor blocker tocilizumab"
],
"C": [
"supportive care only"
],
"O": [
"a 7 - item WHO - endorsed scale",
"discharge from the hospital",
"hospital mortality",
"mechanical ventilation"
]
}
|
Title : Effect of anakinra versus usual care in adults in hospital with COVID - 19 and mild - to - moderate pneumonia ( CORIMUNO - ANA - 1 ) : a randomised controlled trial . METHODS : In this multicentre , open - label , Bayesian randomised clinical trial ( CORIMUNO - ANA - 1 ) , nested within the CORIMUNO - 19 cohort , we recruited patients from 16 University hospitals in France with mild - to - moderate COVID - 19 pneumonia , severe acute respiratory syndrome coronavirus 2 infection confirmed by real - time RT - PCR , requiring at least 3 L / min of oxygen by mask or nasal cannula but without ventilation assistance , a score of 5 on the WHO Clinical Progression Scale ( WHO - CPS ) , and a C - reactive protein serum concentration of more than 25 mg / L not requiring admission to the intensive care unit at admission to hospital . Eligible patients were randomly assigned ( 1 : 1 ) using a web - based secure centralised system , stratified by centre and blocked with varying block sizes ( randomly of size two or four ) , to either usual care plus anakinra ( 200 mg twice a day on days 1 - 3 , 100 mg twice on day 4 , 100 mg once on day 5 ) or usual care alone . Usual care was provided at the discretion of the site clinicians . The two coprimary outcomes were the proportion of patients who had died or needed non - invasive or mechanical ventilation by day 4 ( ie , a score of > 5 on the WHO - CPS ) and survival without need for mechanical or non - invasive ventilation ( including high - flow oxygen ) at day 14 . All analyses were done on an intention - to - treat basis . The trial is registered with ClinicalTrials . gov , NCT04341584 , and is now closed to accrual .
|
{
"P": [
"adults in hospital with COVID - 19 and mild - to - moderate pneumonia",
"patients from 16 University hospitals in France with mild - to - moderate COVID - 19 pneumonia , severe acute respiratory syndrome coronavirus 2 infection confirmed by real - time RT - PCR , requiring at least 3 L / min of oxygen by mask or nasal cannula but without ventilation assistance , a score of 5 on the WHO Clinical Progression Scale ( WHO - CPS ) , and a C - reactive protein serum concentration of more than 25 mg / L not requiring admission to the intensive care unit at admission to hospital"
],
"I": [
"anakinra",
"usual care"
],
"C": [
"usual care",
"usual care alone",
"Usual care"
],
"O": [
"the proportion of patients who had died",
"needed non - invasive",
"mechanical ventilation",
"survival without need for mechanical",
"non - invasive ventilation"
]
}
|
Title : Homemade valved holding chambers for children with airway hyperresponsiveness : A randomized crossover trial . METHODS : In a randomized , two - period , two - sequence crossover trial , we recruited 20 children , aged 6 - 15 years , who had a greater than 12 % increase in FEV1 after inhaled salbutamol . They were randomized into Group A and B . Group A used our VHC on the first day and Aerochamber on the second day . Group B used the same VHCs but in alternate sequence . Spirometries were performed before and after 400 g of salbutamol , MDI was administered via those VHCs .
|
{
"P": [
"children with airway hyperresponsiveness",
"20 children , aged 6 - 15 years , who had a greater than 12 % increase in FEV1 after inhaled salbutamol"
],
"I": [
"Homemade valved holding chambers",
"our VHC",
"Aerochamber",
"the same VHCs",
"those VHCs"
],
"C": [],
"O": [
"Spirometries"
]
}
|
Title : Poor Safety and Tolerability Hamper Reaching a Potentially Therapeutic Dose in the Use of Thalidomide for Alzheimer ' s Disease : Results from a Double - Blind , Placebo - Controlled Trial . METHODS : This was a 24 - week , randomized , double - blind , placebo - controlled , parallel group study with escalating dose regimen of thalidomide with a target dose of 400 mg daily in patients with mild to moderate AD . The primary outcome measures were tolerability and cognitive performance assessed by a battery of tests .
|
{
"P": [
"patients with mild to moderate AD"
],
"I": [
"Thalidomide",
"thalidomide"
],
"C": [],
"O": [
"tolerability",
"cognitive performance"
]
}
|
Title : [ Correlation analysis on changes between cognitive ability and brain fMRI after acupoint thread embedding in Alzheimer ' s disease patients ] . METHODS : Twenty - six patients with mild to moderate AD were assigned to the tested group and the control group in pairing , 13 in each group . ATE was performed in patients of the tested group at Shenmen ( HT7 ) , Fenglong ( ST40 ) , Taixi ( KI3 ) and Zusanli ( ST36 ) acupoints , once every month for 6 times in total ; but for patients of the control group only sham operation was done at the same acupoints . The correlation between cognitive ability and fMRI were assessed by comparing the scores of Mini - Mental State Examination ( MMSE ) and Alzhemer ' s Disease Assessment Scale - Cognitive section ( ADAS - Cog ) , monitored at two time points , namely , in one week before starting treatment and 1 week after terminating 6 - month treatment . Furthermore , fMRI was detected to obtain the data of the cerebral blood oxygen content before treatment and 6 months after completing the 6 - month therapeutic course . Correlation analysis was conducted on the obtained data using software SPM .
|
{
"P": [
"Alzheimer ' s disease patients",
"Twenty - six patients with mild to moderate AD"
],
"I": [
"acupoint thread embedding",
"ATE"
],
"C": [],
"O": [
"cognitive ability",
"fMRI",
"the scores of Mini - Mental State Examination ( MMSE )",
"Alzhemer ' s Disease Assessment Scale - Cognitive section ( ADAS - Cog )",
"the cerebral blood oxygen content"
]
}
|
Title : Peginterferon lambda for the treatment of outpatients with COVID - 19 : a phase 2 , placebo - controlled randomised trial . METHODS : In this double - blind , placebo - controlled trial , outpatients with laboratory - confirmed COVID - 19 were randomly assigned to a single subcutaneous injection of peginterferon lambda 180 ?g or placebo within 7 days of symptom onset or first positive swab if asymptomatic . Participants were randomly assigned ( 1 : 1 ) using a computer - generated randomisation list created with a randomisation schedule in blocks of four . At the time of administration , study nurses received a sealed opaque envelope with the treatment allocation number . The primary endpoint was the proportion of patients who were negative for severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) RNA on day 7 after the injection , analysed by a ?2 test following an intention - to - treat principle . Prespecified analysis of the primary endpoint , adjusted for baseline viral load , using bivariate logistic regression was done . The trial is now complete . This trial is registered with ClinicalTrials . gov , NCT04354259 .
|
{
"P": [
"outpatients with COVID - 19",
"outpatients with laboratory - confirmed COVID - 19"
],
"I": [
"Peginterferon lambda",
"peginterferon lambda"
],
"C": [
"placebo"
],
"O": [
"the proportion of patients who were negative for severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) RNA",
"viral load"
]
}
|
Title : Intravenous methylprednisolone pulse as a treatment for hospitalised severe COVID - 19 patients : results from a randomised controlled clinical trial . METHODS : We conducted a single - blind , randomised controlled clinical trial involving severe hospitalised patients with confirmed COVID - 19 at the early pulmonary phase of the illness in Iran . The patients were randomly allocated in a 1 : 1 ratio by the block randomisation method to receive standard care with methylprednisolone pulse ( intravenous injection , 250 mgday - 1 for 3 days ) or standard care alone . The study end - point was the time of clinical improvement or death , whichever came first . Primary and safety analysis was done in the intention - to - treat ( ITT ) population .
|
{
"P": [
"hospitalised severe COVID - 19 patients",
"severe hospitalised patients with confirmed COVID - 19 at the early pulmonary phase of the illness in Iran"
],
"I": [
"Intravenous methylprednisolone pulse",
"standard care",
"methylprednisolone pulse"
],
"C": [
"standard care alone"
],
"O": [
"the time of clinical improvement",
"death"
]
}
|
Title : Azithromycin in patients admitted to hospital with COVID - 19 ( RECOVERY ) : a randomised , controlled , open - label , platform trial . METHODS : In this randomised , controlled , open - label , adaptive platform trial ( Randomised Evaluation of COVID - 19 Therapy [ RECOVERY ] ) , several possible treatments were compared with usual care in patients admitted to hospital with COVID - 19 in the UK . The trial is underway at 176 hospitals in the UK . Eligible and consenting patients were randomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once per day by mouth or intravenously for 10 days or until discharge ( or allocation to one of the other RECOVERY treatment groups ) . Patients were assigned via web - based simple ( unstratified ) randomisation with allocation concealment and were twice as likely to be randomly assigned to usual care than to any of the active treatment groups . Participants and local study staff were not masked to the allocated treatment , but all others involved in the trial were masked to the outcome data during the trial . The primary outcome was 28 - day all - cause mortality , assessed in the intention - to - treat population . The trial is registered with ISRCTN , 50189673 , and ClinicalTrials . gov , NCT04381936 .
|
{
"P": [
"patients admitted to hospital with COVID - 19",
"patients admitted to hospital with COVID - 19 in the UK"
],
"I": [
"Azithromycin",
"usual standard of care",
"azithromycin"
],
"C": [
"usual standard of care alone"
],
"O": [
"28 - day all - cause mortality"
]
}
|
Title : The effects on cognitive functions of a movement - based intervention in patients with Alzheimer ' s type dementia : a pilot study . METHODS : The sample consisted of 27 patients fulfilling the AD ICD - 10 diagnostic criteria . The patient sample was randomly divided into two groups : The Exercise Group received 6 weeks movement training and comprised 15 participants with a mean age of 70 . 5 years ( SD : 8 ) . Control Group participated in a standard care group , which served as a control intervention , and consisted of 12 patients with an average age of 75 . 7 years ( SD : 6 . 90 ) . Cognitive functions were assessed using six computerised tests from the CANTAB , pre and post training . Data were analysed using t - tests . The false discovery rate ( FDR ) for multiple comparisons as well as Cohen ' s d effect size was used to assess the significant effects .
|
{
"P": [
"patients with Alzheimer ' s type dementia",
"27 patients fulfilling the AD ICD - 10 diagnostic criteria"
],
"I": [
"a movement - based intervention",
"The Exercise",
"6 weeks movement training"
],
"C": [
"a standard care"
],
"O": [
"Cognitive functions",
"six computerised tests from the CANTAB"
]
}
|
Title : Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID - 19 in Brazil ( COALITION II ) : a randomised clinical trial . METHODS : We did an open - label , randomised clinical trial at 57 centres in Brazil . We enrolled patients admitted to hospital with suspected or confirmed COVID - 19 and at least one additional severity criteria as follows : use of oxygen supplementation of more than 4 L / min flow ; use of high - flow nasal cannula ; use of non - invasive mechanical ventilation ; or use of invasive mechanical ventilation . Patients were randomly assigned ( 1 : 1 ) to azithromycin ( 500 mg via oral , nasogastric , or intravenous administration once daily for 10 days ) plus standard of care or to standard of care without macrolides . All patients received hydroxychloroquine ( 400 mg twice daily for 10 days ) because that was part of standard of care treatment in Brazil for patients with severe COVID - 19 . The primary outcome , assessed by an independent adjudication committee masked to treatment allocation , was clinical status at day 15 after randomisation , assessed by a six - point ordinal scale , with levels ranging from 1 to 6 and higher scores indicating a worse condition ( with odds ratio [ OR ] greater than 100 favouring the control group ) . The primary outcome was assessed in all patients in the intention - to - treat ( ITT ) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation ( ie , modified ITT [ mITT ] population ) . Safety was assessed in all patients according to which treatment they received , regardless of original group assignment . This trial was registered at ClinicalTrials . gov , NCT04321278 .
|
{
"P": [
"patients admitted to the hospital with severe COVID - 19 in Brazil",
"patients admitted to hospital with suspected or confirmed COVID - 19"
],
"I": [
"Azithromycin",
"standard of care",
"azithromycin",
"hydroxychloroquine"
],
"C": [
"standard of care alone",
"standard of care",
"macrolides"
],
"O": [
"clinical status",
"a six - point ordinal scale"
]
}
|
Title : Add - on prolonged - release melatonin for cognitive function and sleep in mild to moderate Alzheimer ' s disease : a 6 - month , randomized , placebo - controlled , multicenter trial . METHODS : The effects of add - on prolonged - release melatonin ( PRM ) ( 2 mg ) to standard therapy on cognitive functioning and sleep were investigated in 80 patients ( men [ 50 . 7 % ] , women [ 49 . 3 % ] , average age 75 . 3 years [ range , 52 - 85 years ] ) diagnosed with mild to moderate AD , with and without insomnia comorbidity , and receiving standard therapy ( acetylcholinesterase inhibitors with or without memantine ) . In this randomized , double - blind , parallel - group study , patients were treated for 2 weeks with placebo and then randomized ( 1 : 1 ) to receive 2 mg of PRM or placebo nightly for 24 weeks , followed by 2 weeks placebo . The AD Assessment Scale - Cognition ( ADAS - Cog ) , Instrumental Activities of Daily Living ( IADL ) , Mini - Mental State Examination ( MMSE ) , sleep , as assessed by the Pittsburgh Sleep Quality Index ( PSQI ) and a daily sleep diary , and safety parameters were measured .
|
{
"P": [
"80 patients ( men [ 50 . 7 % ] , women [ 49 . 3 % ] , average age 75 . 3 years [ range , 52 - 85 years ] ) diagnosed with mild to moderate AD , with and without insomnia comorbidity , and receiving standard therapy ( acetylcholinesterase inhibitors with or without memantine )"
],
"I": [
"Add - on prolonged - release melatonin",
"add - on prolonged - release melatonin ( PRM )",
"2 mg of PRM"
],
"C": [
"standard therapy",
"placebo",
"2 weeks placebo"
],
"O": [
"The AD Assessment Scale - Cognition ( ADAS - Cog )",
"Instrumental Activities of Daily Living ( IADL )",
"Mini - Mental State Examination ( MMSE )",
"sleep",
"the Pittsburgh Sleep Quality Index ( PSQI )",
"a daily sleep diary",
"safety parameters"
]
}
|
Title : Antiaggressive effect of cyproterone versus haloperidol in Alzheimer ' s disease : a randomized double - blind pilot study . METHODS : The subjects were 27 elderly patients referred to the University Hospital of Guadalajara Psychogeriatric Clinic diagnosed with AD and associated aggressive behavior ( mean Staff Observation Aggression Scale [ SOAS ] score > or=2 ) . Each patient underwent a 15 - day washout for psychotropics and then was randomly assigned to receive stable doses of either cyproterone ( 100 mg / day ) or haloperidol ( 2 mg / day ) for 90 days . The primary outcome measure was the SOAS score . This trial was conducted between October 27 , 1993 , and March 24 , 1998 .
|
{
"P": [
"27 elderly patients referred to the University Hospital of Guadalajara Psychogeriatric Clinic diagnosed with AD and associated aggressive behavior ( mean Staff Observation Aggression Scale [ SOAS ] score > or=2 )"
],
"I": [
"cyproterone",
"haloperidol"
],
"C": [],
"O": [
"the SOAS score"
]
}
|
Title : Nature and Dimensions of Systemic Hyperinflammation and its Attenuation by Convalescent Plasma in Severe COVID - 19 . METHODS : First , to characterize key cytokines and their dynamics in this hyperinflammatory condition , we assessed abundance and correlative expression of a panel of 48 cytokines in patients progressing to ARDS as compared to patients with mild disease . Then , in an ongoing randomized controlled trial of convalescent plasma therapy ( CPT ) , we analyzed rapid effects of CPT on the systemic cytokine dynamics as a correlate for the level of hypoxia experienced by the patients .
|
{
"P": [
"patients progressing to ARDS as compared to patients with mild disease"
],
"I": [
"Convalescent Plasma",
"convalescent plasma therapy ( CPT )",
"CPT"
],
"C": [],
"O": [
"systemic cytokine dynamics",
"the level of hypoxia experienced by the patients"
]
}
|
Title : Effect of statins on Alzheimer ' s disease biomarkers in cerebrospinal fluid . METHODS : We measured levels of cerebrospinal fluid ( CSF ) AD biomarkers following 14 weeks of treatment with simvastatin ( a CNS permeant statin ; n=10 ) at 40 mg / day or pravastatin ( a CNS impermeant statin ; n=13 ) at 80 mg / day in hypercholesterolemic subjects without dementia .
|
{
"P": [
"hypercholesterolemic subjects without dementia"
],
"I": [
"statins",
"simvastatin",
"a CNS permeant statin",
"pravastatin",
"a CNS impermeant statin"
],
"C": [],
"O": [
"levels of cerebrospinal fluid ( CSF ) AD biomarkers"
]
}
|
Title : Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID - 19 : A Randomized Clinical Trial . METHODS : Randomized , open - label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) infection and moderate COVID - 19 pneumonia ( pulmonary infiltrates and room - air oxygen saturation > 94 % ) enrolled from March 15 through April 18 , 2020 , at 105 hospitals in the United States , Europe , and Asia . The date of final follow - up was May 20 , 2020 . Patients were randomized in a 1:1:1 ratio to receive a 10 - day course of remdesivir ( n = 197 ) , a 5 - day course of remdesivir ( n = 199 ) , or standard care ( n = 200 ) . Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg / d . The primary end point was clinical status on day 11 on a 7 - point ordinal scale ranging from death ( category 1 ) to discharged ( category 7 ) . Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios . An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group .
|
{
"P": [
"Patients With Moderate COVID - 19",
"hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 ( SARS - CoV - 2 ) infection and moderate COVID - 19 pneumonia ( pulmonary infiltrates and room - air oxygen saturation > 94 % ) enrolled from March 15 through April 18 , 2020 , at 105 hospitals in the United States , Europe , and Asia"
],
"I": [
"Remdesivir",
"a 10 - day course of remdesivir",
"a 5 - day course of remdesivir",
"remdesivir treatment",
"the remdesivir"
],
"C": [
"Standard Care",
"standard care",
"the standard care"
],
"O": [
"clinical status",
"a 7 - point ordinal scale"
]
}
|
Title : The value of subtraction MRI in detection of amyloid - related imaging abnormalities with oedema or effusion in Alzheimer ' s patients : An interobserver study . METHODS : We included 75 AD patients receiving bapineuzumab treatment , including 29 ARIA - E cases . Five neuroradiologists rated their brain MRI - scans with and without subtraction images . The accuracy of evaluating the presence of ARIA - E , intraclass correlation coefficient ( ICC ) and specific agreement was calculated .
|
{
"P": [
"75 AD patients receiving bapineuzumab treatment , including 29 ARIA - E cases"
],
"I": [
"subtraction MRI",
"with",
"without subtraction images"
],
"C": [],
"O": [
"The accuracy of evaluating the presence of ARIA - E",
"intraclass correlation coefficient ( ICC )",
"specific agreement"
]
}
|
Title : Donepezil treatment of patients with MCI : a 48 - week randomized , placebo - controlled trial . METHODS : In this multicenter , randomized , placebo - controlled trial , subjects with MCI entered a 3 - week placebo run - in period followed by 48 weeks of double - blind donepezil ( 5 mg / day for 6 weeks , then 10 mg / day for 42 weeks ) or placebo treatment . Primary efficacy variables included change from baseline in the modified Alzheimer Disease Assessment Scale - cognitive subscale ( ADAS - Cog ) and Clinical Dementia Rating Scale - sum of boxes ( CDR - SB ) after 48 weeks of treatment ( modified intention - to - treat analysis ) . Secondary efficacy measures evaluated cognition , behavior , and function .
|
{
"P": [
"patients with MCI",
"subjects with MCI"
],
"I": [
"Donepezil treatment",
"48 weeks of double - blind donepezil"
],
"C": [
"placebo treatment"
],
"O": [
"the modified Alzheimer Disease Assessment Scale - cognitive subscale ( ADAS - Cog )",
"Clinical Dementia Rating Scale - sum of boxes ( CDR - SB )",
"cognition",
"behavior",
"function"
]
}
|
Title : Effect of Hydrocortisone on 21 - Day Mortality or Respiratory Support Among Critically Ill Patients With COVID - 19 : A Randomized Clinical Trial . METHODS : Multicenter randomized double - blind sequential trial conducted in France , with interim analyses planned every 50 patients . Patients admitted to the intensive care unit ( ICU ) for COVID - 19 - related acute respiratory failure were enrolled from March 7 to June 1 , 2020 , with last follow - up on June 29 , 2020 . The study intended to enroll 290 patients but was stopped early following the recommendation of the data and safety monitoring board . Patients were randomized to receive low - dose hydrocortisone ( n = 76 ) or placebo ( n = 73 ) . The primary outcome , treatment failure on day 21 , was defined as death or persistent dependency on mechanical ventilation or high - flow oxygen therapy . Prespecified secondary outcomes included the need for tracheal intubation ( among patients not intubated at baseline ) ; cumulative incidences ( until day 21 ) of prone position sessions , extracorporeal membrane oxygenation , and inhaled nitric oxide ; Pao2 : Fio2 ratio measured daily from day 1 to day 7 , then on days 14 and 21 ; and the proportion of patients with secondary infections during their ICU stay .
|
{
"P": [
"Critically Ill Patients With COVID - 19",
"Patients admitted to the intensive care unit ( ICU ) for COVID - 19 - related acute respiratory failure"
],
"I": [
"Hydrocortisone",
"low - dose hydrocortisone"
],
"C": [
"placebo"
],
"O": [
"treatment failure",
"death",
"persistent dependency on mechanical ventilation",
"high - flow oxygen therapy",
"the need for tracheal intubation",
"cumulative incidences ( until day 21 ) of prone position sessions",
"extracorporeal membrane oxygenation",
"inhaled nitric oxide",
"Pao2 : Fio2 ratio",
"the proportion of patients with secondary infections"
]
}
|
Title : Dexamethasone in Hospitalized Patients with Covid - 19 . METHODS : In this controlled , open - label trial comparing a range of possible treatments in patients who were hospitalized with Covid - 19 , we randomly assigned patients to receive oral or intravenous dexamethasone ( at a dose of 6 mg once daily ) for up to 10 days or to receive usual care alone . The primary outcome was 28 - day mortality . Here , we report the final results of this assessment .
|
{
"P": [
"Hospitalized Patients with Covid - 19",
"patients who were hospitalized with Covid - 19"
],
"I": [
"Dexamethasone",
"oral",
"intravenous dexamethasone"
],
"C": [
"usual care alone"
],
"O": [
"28 - day mortality"
]
}
|
Title : Effectiveness of donepezil in reducing clinical worsening in patients with mild - to - moderate alzheimer ' s disease . METHODS : Data from 906 patients ( 388 receiving placebo ; 518 receiving donepezil ) with mild - to - moderate AD [ Mini - Mental State Examination ( MMSE ) score 10 - 27 ] were pooled from 3 randomized , double - blind placebo - controlled studies . Clinical worsening was defined as decline in ( 1 ) cognition ( MMSE ) , ( 2 ) cognition and global ratings ( Clinician ' s Interview - Based Impression of Change plus Caregiver Input / Gottfries - Brne - Steen scale ) or ( 3 ) cognition , global ratings and function ( various functional measures ) .
|
{
"P": [
"patients with mild - to - moderate alzheimer ' s disease",
"906 patients ( 388 receiving placebo ; 518 receiving donepezil ) with mild - to - moderate AD [ Mini - Mental State Examination ( MMSE ) score 10 - 27 ]"
],
"I": [
"donepezil"
],
"C": [],
"O": [
"cognition",
"MMSE",
"global ratings",
"Clinician ' s Interview - Based Impression of Change plus Caregiver Input",
"Gottfries - Brne - Steen scale",
"function",
"various functional measures"
]
}
|
Title : Effect of tacrine on language , praxis , and noncognitive behavioral problems in Alzheimer disease . METHODS : An exploratory analysis using last observation carried forward . The study population included a placebo group ( n = 181 ) and all patients randomized to treatment within 160 mg / d of tacrine hydrochloride ( n = 234 ) , regardless of highest dose achieved or duration of tacrine therapy . Male and female subjects , at least 50 years of age , with mild to moderate AD and detectable baseline deficits in discrete cognitive and noncognitive parameters . Change from baseline to last observation carried forward in discrete subscale scores of the Alzheimer ' s Disease Assessment Scale ( ADAS ) : cognitive ( memory , language , praxis ) and noncognitive ( mood , behavior ) . Improvement was defined as a decrease of at least 1 point from baseline ; stabilization was defined as no change or a decrease from baseline .
|
{
"P": [
"Male and female subjects , at least 50 years of age , with mild to moderate AD and detectable baseline deficits in discrete cognitive and noncognitive parameters"
],
"I": [
"tacrine",
"160 mg / d of tacrine hydrochloride",
"tacrine therapy"
],
"C": [
"a placebo"
],
"O": [
"discrete subscale scores of the Alzheimer ' s Disease Assessment Scale ( ADAS )",
"cognitive",
"memory",
"language",
"praxis",
"noncognitive",
"mood",
"behavior"
]
}
|
Title : Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease : a randomized controlled trial . METHODS : A multicenter , randomized , double - blind , placebo - controlled trial enrolling patients with mild AD was conducted at 133 trial sites in the United States between February 21 , 2005 , and April 30 , 2008 . Concomitant treatment with cholinesterase inhibitors or memantine was permitted . Tarenflurbil , 800 mg , or placebo , administered twice a day . Co - primary efficacy end points were the change from baseline to month 18 in total score on the subscale of the Alzheimer Disease Assessment Scale - Cognitive Subscale ( ADAS - Cog , 80 - point version ) and Alzheimer Disease Cooperative Studies - activities of daily living ( ADCS - ADL ) scale . Additional prespecified slope analyses explored the possibility of disease modification .
|
{
"P": [
"patients with mild Alzheimer disease",
"patients with mild AD"
],
"I": [
"tarenflurbil",
"Tarenflurbil"
],
"C": [
"placebo"
],
"O": [
"the subscale of the Alzheimer Disease Assessment Scale - Cognitive Subscale ( ADAS - Cog , 80 - point version )",
"Alzheimer Disease Cooperative Studies - activities of daily living ( ADCS - ADL ) scale"
]
}
|
Title : [ A pilot study of hydroxychloroquine in treatment of patients with moderate COVID - 19 ] . METHODS : We prospectively enrolled 30 treatment - nave patients with confirmed COVID - 19 after informed consent at Shanghai Public Health Clinical Center . The patients were randomized 1?1 to HCQ group and the control group . Patients in HCQ group were given HCQ 400 mg per day for 5 days plus conventional treatments , while those in the control group were given conventional treatment only . The primary endpoint was negative conversion rate of SARS - CoV - 2 nucleic acid in respiratory pharyngeal swab on days 7 after randomization . This study has been approved by the Ethics Committee of Shanghai Public Health Clinical Center and registered online ( NCT04261517 ) .
|
{
"P": [
"patients with moderate COVID - 19",
"30 treatment - nave patients with confirmed COVID - 19 after informed consent at Shanghai Public Health Clinical Center"
],
"I": [
"hydroxychloroquine",
"HCQ",
"conventional treatments"
],
"C": [
"conventional treatment only"
],
"O": [
"negative conversion rate of SARS - CoV - 2 nucleic acid in respiratory pharyngeal swab"
]
}
|
Title : Evaluation of Ivermectin as a Potential Treatment for Mild to Moderate COVID - 19 : A Double - Blind Randomized Placebo Controlled Trial in Eastern India . METHODS : A double blind , parallel , randomised , placebo - controlled trial conducted among adult COVID - 19 patients with mild to moderate disease severity on admission in a COVID dedicated tertiary healthcare of eastern India . Enrolment was done between 1 st August and 31 st October 2020 . On day 1 and 2 post enrolment , patients in the intervention arm received ivermectin 12 mg while the patients in the non - interventional arm received placebo tablets .
|
{
"P": [
"adult COVID - 19 patients with mild to moderate disease severity on admission in a COVID dedicated tertiary healthcare of eastern India"
],
"I": [
"Ivermectin",
"ivermectin"
],
"C": [
"placebo"
],
"O": []
}
|
Title : Double - blind , Randomized , Placebo - controlled Trial With N - acetylcysteine for Treatment of Severe Acute Respiratory Syndrome Caused by Coronavirus Disease 2019 ( COVID - 19 ) . METHODS : This was a double - blind , randomized , placebo - controlled , single - center trial conducted at the Emergency Department of Hospital das Clnicas , So Paulo , Brazil , to determine whether NAC in high doses can avoid respiratory failure in patients with COVID - 19 . We enrolled 135 patients with severe COVID - 19 ( confirmed or suspected ) , with an oxyhemoglobin saturation < 94 % or respiratory rate > 24 breaths / minute . Patients were randomized to receive NAC 21 g ( ~ 300 mg / kg ) for 20 hours or dextrose 5 % . The primary endpoint was the need for mechanical ventilation . Secondary endpoints were time of mechanical ventilation , admission to the intensive care unit ( ICU ) , time in ICU , and mortality .
|
{
"P": [
"patients with COVID - 19",
"135 patients with severe COVID - 19 ( confirmed or suspected ) , with an oxyhemoglobin saturation < 94 % or respiratory rate > 24 breaths / minute"
],
"I": [
"N - acetylcysteine",
"NAC"
],
"C": [
"dextrose"
],
"O": [
"the need for mechanical ventilation",
"time of mechanical ventilation",
"admission to the intensive care unit ( ICU )",
"time in ICU",
"mortality"
]
}
|
Title : Early use of nitazoxanide in mild COVID - 19 disease : randomised , placebo - controlled trial . METHODS : In a multicentre , randomised , double - blind , placebo - controlled trial , adult patients presenting up to 3 days after onset of coronavirus disease 2019 ( COVID - 19 ) symptoms ( dry cough , fever and / or fatigue ) were enrolled . After confirmation of SARS - CoV - 2 infection using reverse transcriptase PCR on a nasopharyngeal swab , patients were randomised 1 : 1 to receive either nitazoxanide ( 500 mg ) or placebo , three times daily , for 5 days . The primary outcome was complete resolution of symptoms . Secondary outcomes were viral load , laboratory tests , serum biomarkers of inflammation and hospitalisation rate . Adverse events were also assessed .
|
{
"P": [
"adult patients presenting up to 3 days after onset of coronavirus disease 2019 ( COVID - 19 ) symptoms ( dry cough , fever and / or fatigue )"
],
"I": [
"nitazoxanide"
],
"C": [
"placebo"
],
"O": [
"complete resolution of symptoms",
"viral load",
"laboratory tests",
"serum biomarkers of inflammation",
"hospitalisation rate",
"Adverse events"
]
}
|
Title : Auxora versus standard of care for the treatment of severe or critical COVID - 19 pneumonia : results from a randomized controlled trial . METHODS : A randomized , controlled , open - label study of Auxora was conducted in adults with severe or critical COVID - 19 pneumonia . Patients were randomized 2 : 1 to receive three doses of once - daily Auxora versus standard of care ( SOC ) alone . The primary objective was to assess the safety and tolerability of Auxora . Following FDA guidance , study enrollment was halted early to allow for transition to a randomized , blinded , placebo - controlled study .
|
{
"P": [
"adults with severe or critical COVID - 19 pneumonia"
],
"I": [
"Auxora",
"three doses of once - daily Auxora"
],
"C": [
"standard of care",
"standard of care ( SOC ) alone"
],
"O": [
"the safety",
"tolerability"
]
}
|
Title : A randomized , crossover trial of high - carbohydrate foods in nursing home residents with Alzheimer ' s disease : associations among intervention response , body mass index , and behavioral and cognitive function . METHODS : Thirty - four nursing home residents with probable AD who ate independently participated in a randomized , crossover , nonblinded study of two nutrition interventions . The intervention described here included replacing 12 nonconsecutive " traditional " dinners with meals high in carbohydrate but comparable to traditional dinners in protein . Measures included weighed food intake , body weight , cognitive function ( as assessed using the Severe Impairment Battery and Global Deterioration Scale ) , behavioral disturbances ( as assessed using the Neuropsychiatric Inventory - Nursing Home Version ) , and behavioral function ( as assessed using the London Psychogeriatric Rating Scale ) .
|
{
"P": [
"nursing home residents with Alzheimer ' s disease",
"Thirty - four nursing home residents with probable AD who ate independently"
],
"I": [
"high - carbohydrate foods",
"meals high in carbohydrate"
],
"C": [
"traditional dinners"
],
"O": [
"weighed food intake",
"body weight",
"cognitive function",
"the Severe Impairment Battery",
"Global Deterioration Scale",
"behavioral disturbances",
"the Neuropsychiatric Inventory - Nursing Home Version",
"behavioral function",
"the London Psychogeriatric Rating Scale"
]
}
|
Title : Early Use of Corticosteroid May Prolong SARS - CoV - 2 Shedding in Non - Intensive Care Unit Patients with COVID - 19 Pneumonia : A Multicenter , Single - Blind , Randomized Control Trial . METHODS : This was a prospective , multicenter , single - blind , randomized control trial . Adult patients with COVID - 19 pneumonia who were admitted to the general ward were randomly assigned to either receive methylprednisolone or not for 7 days . The primary end point was the incidence of clinical deterioration 14 days after randomization .
|
{
"P": [
"Non - Intensive Care Unit Patients with COVID - 19 Pneumonia",
"Adult patients with COVID - 19 pneumonia who were admitted to the general ward"
],
"I": [
"Corticosteroid",
"methylprednisolone"
],
"C": [
"not"
],
"O": [
"the incidence of clinical deterioration"
]
}
|
Title : Heat - processed ginseng enhances the cognitive function in patients with moderately severe Alzheimer ' s disease . METHODS : Forty patients with AD were randomized into one of three different dose groups or the control group as follows : 1 . 5 g / day ( n = 10 ) , 3 g / day ( n = 10 ) , and 4 . 5 g / day ( n = 10 ) groups , or control ( n = 10 ) . The Alzheimer ' s Disease Assessment Scale ( ADAS ) and Mini - Mental State Examination ( MMSE ) were used to assess cognitive function for 24 weeks .
|
{
"P": [
"patients with moderately severe Alzheimer ' s disease",
"Forty patients with AD"
],
"I": [
"Heat - processed ginseng"
],
"C": [],
"O": [
"The Alzheimer ' s Disease Assessment Scale ( ADAS )",
"Mini - Mental State Examination ( MMSE )"
]
}
|
Title : Hydroxychloroquine in mild - to - moderate coronavirus disease 2019 : a placebo - controlled double blind trial . METHODS : We conducted a multicentre randomized double - blind placebo - controlled trial evaluating hydroxychloroquine in COVID - 19 patients with at least one of the following risk factors for worsening : need for supplemental oxygen , age ?75 years , age between 60 and 74 years and presence of at least one co - morbidity . Severely ill patients requiring oxygen therapy > 3 L / min or intensive care were excluded . Eligible patients were randomized in a 1 : 1 ratio to receive either 800 mg hydroxychloroquine on day 0 followed by 400 mg per day for 8 days or a placebo . The primary end point was a composite of death or start of invasive mechanical ventilation within 14 days following randomization . Secondary end points included mortality and clinical evolution at days 14 and 28 , and viral shedding at days 5 and 10 .
|
{
"P": [
"COVID - 19 patients with at least one of the following risk factors for worsening : need for supplemental oxygen , age ?75 years , age between 60 and 74 years and presence of at least one co - morbidity"
],
"I": [
"Hydroxychloroquine",
"hydroxychloroquine",
"800 mg hydroxychloroquine"
],
"C": [
"a placebo"
],
"O": [
"a composite of death",
"start of invasive mechanical ventilation",
"mortality",
"clinical evolution",
"viral shedding"
]
}
|
Title : Nano - curcumin therapy , a promising method in modulating inflammatory cytokines in COVID - 19 patients . METHODS : Forty COVID - 19 patients and 40 healthy controls were recruited and evaluated for inflammatory cytokine expression and secretion . Subsequently , COVID - 19 patients were divided into two groups : 20 patients receiving Nano - curcumin and 20 patients as the placebo group . The mRNA expression and cytokine secretion levels of IL - 1? , IL - 6 , TNF - ? and IL - 18 were assessed by Real - time PCR and ELISA , respectively .
|
{
"P": [
"COVID - 19 patients",
"Forty COVID - 19 patients and 40 healthy controls"
],
"I": [
"Nano - curcumin therapy",
"Nano - curcumin"
],
"C": [
"the placebo"
],
"O": [
"The mRNA expression",
"cytokine secretion levels of IL - 1?",
"IL - 6",
"TNF - ?",
"IL - 18",
"Real - time PCR",
"ELISA"
]
}
|
Title : A Cluster - Randomized Trial of Hydroxychloroquine for Prevention of Covid - 19 . METHODS : We conducted an open - label , cluster - randomized trial involving asymptomatic contacts of patients with polymerase - chain - reaction ( PCR ) - confirmed Covid - 19 in Catalonia , Spain . We randomly assigned clusters of contacts to the hydroxychloroquine group ( which received the drug at a dose of 800 mg once , followed by 400 mg daily for 6 days ) or to the usual - care group ( which received no specific therapy ) . The primary outcome was PCR - confirmed , symptomatic Covid - 19 within 14 days . The secondary outcome was SARS - CoV - 2 infection , defined by symptoms compatible with Covid - 19 or a positive PCR test regardless of symptoms . Adverse events were assessed for up to 28 days .
|
{
"P": [
"asymptomatic contacts of patients with polymerase - chain - reaction ( PCR ) - confirmed Covid - 19 in Catalonia , Spain"
],
"I": [
"Hydroxychloroquine",
"the hydroxychloroquine"
],
"C": [
"the usual - care"
],
"O": [
"PCR - confirmed , symptomatic Covid - 19",
"SARS - CoV - 2 infection",
"symptoms compatible with Covid - 19",
"a positive PCR test regardless of symptoms",
"Adverse events"
]
}
|
Title : Tocilizumab combined with favipiravir in the treatment of COVID - 19 : A multicenter trial in a small sample size . METHODS : This was a multicenter trial in adults with COVID - 19 . Patients were randomly assigned ( 3:1:1 ) to a 14 - day combination of favipiravir combined with tocilizumab ( combination group ) , favipiravir , and tocilizumab . The primary outcome was the cumulative lung lesion remission rate ( lung CT examination indicated absorption of lung inflammation ) .
|
{
"P": [
"adults with COVID - 19"
],
"I": [
"Tocilizumab",
"favipiravir",
"a 14 - day combination of favipiravir",
"tocilizumab"
],
"C": [],
"O": [
"the cumulative lung lesion remission rate",
"lung CT examination indicated absorption of lung inflammation"
]
}
|
Title : Efficacy of two siddha polyherbal decoctions , Nilavembu Kudineer and Kaba Sura Kudineer , along with standard allopathy treatment in the management of mild to moderate symptomatic COVID - 19 patients - a double - blind , placebo - controlled , clinical trial . METHODS : The study was a double - blind , placebo - controlled comparative clinical trial , with the primary objective of determining the efficacy of KSK and NVK . Patients ( n=125 ) diagnosed with mild to moderate COVID - 19 symptoms were enrolled in the study over a period of 4 months ( Aug 2020 - Dec 2020 ) . Participants were randomized into 3 arms ; placebo - decaffeinated tea in Arm I , NVK in Arm II , and KSK in Arm III . Each arm received 60 ml of the respective treatment twice a day , post morning and evening meals , along with standard allopathy treatment for a maximum of 10 days . The main outcome measures of the study were the reduction in SARS - CoV - 2 viral load , hospital stay , and time taken by the patients to become asymptomatic from symptomatic . Efficacy assessments included clinical symptoms ( fever , cough , and breathlessness ) each day and real - time reverse transcription - polymerase chain reaction ( RT - PCR ) , liver function test ( LFT ) , renal function test ( RFT ) , and electrolytes and electrocardiogram ( ECG ) at baseline ( day 0 ) and days 3 , 6 , and 10 . Post - treatment , participants were followed up for 30 days via phone for adverse effects if any . Effects of drugs on inflammatory markers ( IL6 ) at the end of treatment were also recorded . Adverse events ( AE ) were monitored throughout the study .
|
{
"P": [
"mild to moderate symptomatic COVID - 19 patients",
"Patients ( n=125 ) diagnosed with mild to moderate COVID - 19 symptoms"
],
"I": [
"two siddha polyherbal decoctions",
"Nilavembu Kudineer",
"Kaba Sura Kudineer",
"standard allopathy treatment",
"KSK",
"NVK"
],
"C": [
"placebo",
"decaffeinated tea"
],
"O": [
"SARS - CoV - 2 viral load",
"hospital stay",
"time taken by the patients to become asymptomatic from symptomatic",
"clinical symptoms",
"fever",
"cough",
"breathlessness",
"real - time reverse transcription - polymerase chain reaction ( RT - PCR )",
"liver function test ( LFT )",
"renal function test ( RFT )",
"electrolytes and electrocardiogram ( ECG )",
"inflammatory markers",
"IL6",
"Adverse events ( AE )"
]
}
|
Title : Health and nutrition promotion program for patients with dementia ( NutriAlz ) : cluster randomized trial . METHODS : Cluster randomized multi - centre study with one - year follow - up . 11 Alzheimer outpatients and day care centres ( Barcelona , Spain ) . Nine hundred and forty six home - living Alzheimer patients with identified caregiver were consecutively recruited ( intervention group : 6 centres , 448 patients vs control group : 5 centres , 498 patients ) . The intervention was a teaching and training intervention on health and nutrition program , NutriAlz , directed both to physician and main caregiver , as well as persons affected by Alzheimer ' s disease or other dementias , including a standardised protocol for feeding and nutrition . The main outcome measure was the reduction in the loss of autonomy ( Activities of daily living ( ADL / IADL ) scales ) assessed at 6 and 12 months . Secondary outcomes measures were Improvement in nutritional status ( Mini Nutritional Assessment ( MNA ) , BMI , and weight changes ) , and caregiver burden ( Zarit scale ) .
|
{
"P": [
"patients with dementia",
"Nine hundred and forty six home - living Alzheimer patients with identified caregiver"
],
"I": [
"Health and nutrition promotion program",
"a teaching and training intervention on health and nutrition program"
],
"C": [],
"O": [
"the loss of autonomy",
"Activities of daily living ( ADL / IADL ) scales",
"nutritional status",
"Mini Nutritional Assessment ( MNA )",
"BMI",
"weight changes",
"caregiver burden",
"Zarit scale"
]
}
|
Title : Clinical , Biochemical and Molecular Evaluations of Ivermectin Mucoadhesive Nanosuspension Nasal Spray in Reducing Upper Respiratory Symptoms of Mild COVID - 19 . METHODS : This clinical trial included 114 patients diagnosed as mild COVID - 19 . Patients were divided randomly into two age and sex - matched groups ; group A comprising 57 patients received ivermectin nanosuspension nasal spray twice daily plus the Egyptian protocol of treatment for mild COVID - 19 and group B comprising 57 patients received the Egyptian protocol for mild COVID - 19 only . Evaluation of the patients was performed depending on improvement of presenting manifestations , negativity of two consecutive pharyngeal swabs for the COVID - 19 nucleic acid via rRT - PCR and assessments of hematological and biochemical parameters in the form of complete blood counts , C - reactive protein , serum ferritin and d - dimer which were performed at presentation and 7 days later .
|
{
"P": [
"114 patients diagnosed as mild COVID - 19"
],
"I": [
"Ivermectin Mucoadhesive Nanosuspension Nasal Spray",
"ivermectin nanosuspension nasal spray",
"the Egyptian protocol of treatment for mild COVID - 19"
],
"C": [
"the Egyptian protocol for mild COVID - 19 only"
],
"O": [
"improvement of presenting manifestations",
"negativity of two consecutive pharyngeal swabs for the COVID - 19 nucleic acid",
"rRT - PCR",
"hematological",
"biochemical parameters in the form of complete blood counts",
"C - reactive protein",
"serum ferritin",
"d - dimer"
]
}
|
Title : Safety and efficacy of Favipiravir in moderate to severe SARS - CoV - 2 pneumonia . METHODS : We did a multicenter randomized open - labeled clinical trial on moderate to severe cases infections of SARS - CoV - 2 . Patients with typical ground glass appearance on chest computerized tomography scan ( CT scan ) and oxygen saturation ( SpO2 ) of less than 93 % were enrolled . They were randomly allocated into Favipiravir ( 1 . 6 gr loading , 1 . 8 gr daily ) and Lopinavir / Ritonavir ( 800 / 200 mg daily ) treatment regimens in addition to standard care . In - hospital mortality , ICU admission , intubation , time to clinical recovery , changes in daily SpO2 after 5 min discontinuation of supplemental oxygen , and length of hospital stay were quantified and compared in the two groups .
|
{
"P": [
"Patients with typical ground glass appearance on chest computerized tomography scan ( CT scan ) and oxygen saturation ( SpO2 ) of less than 93 %"
],
"I": [
"Favipiravir",
"Lopinavir",
"Ritonavir",
"standard care"
],
"C": [],
"O": [
"In - hospital mortality",
"ICU admission",
"intubation",
"time to clinical recovery",
"daily SpO2",
"length of hospital stay"
]
}
|
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