linjc16/ctgov huggingface dataset:
How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?

Study Overview
=================
Brief Summary
-----------------
A previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our ICU. That has been related to lack of compliance to hand hygiene among health care providers in ou ICU.

Detailed Description
-----------------
A single-center cohort study performed in the department of Anesthesia and Intensive Care in our Hospital. All endotracheal isolates realised in the period of study are collected from the Department of Microbiology of our Hospital.

Official Title
-----------------
How COVID-19 Virus Outbreak Affects Antimicrobial Resistance in a Low-middle-income Country's ICU?

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Behavioral: Enhanced hygiene measures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring mechanical ventilation for more than 24 hours Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before pandemic is declared<br>Positive endotracheal aspirates addressed from January 1st 2019 to January 1st 2020 | |
| After pandemic is declared<br>Positive endotracheal aspirates addressed from February1st 2020 to February 1st 2021 | Behavioral: Enhanced hygiene measures<br>* Wether or not hygiene measures dictated by the pandemic of severe acute respiratory syndrome coronavirus 19 , reduce multi drug resistant pathogens isolated in endotracheal aspirates.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDR pathogens in endotracheal aspirates | Incidence of MDR bacteria in endotracheal aspirates | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microorganisms in endotracheal aspirates | Incidence of microorganisms in endotracheal aspirates | 1 year |
Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in China

Study Overview
=================
Brief Summary
-----------------
Anti-NMDA receptor encephalitis is the most common curable non-infectious autoimmune encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to establish a database of anti-NMDA receptor encephalitis in Chinese population. The multi-center, prospective clinical trial of anti-NMDA receptor encephalitis in China's , combined with Beijing Xuanwu hospital, Beijing Tiantan Hospital, Beijing Children's Hospital and other hospitals around the country, by screening the NMDA receptor antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of anti-NMDA receptor encephalitis.

Conditions
-----------------
Anti-NMDA Receptor Enphalitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 6 months. Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours; At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities; Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear. Signed informed consent Exclusion Criteria: Infants less than 6 months; The metabolic encephalopathy; Infectious encephalitis with clear pathogen clinically, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on; Non-infectious encephalitis with clear diagnosis clinically, including: multiple sclerosis, neuromyelitis optic, acute disseminated encephalomyelitis and so on.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anti-NMDA receptor encephalitis<br> | |
| other autoimmune encephlitis<br> | |
| other encephalopathy<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 30 days |
Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.

Study Overview
=================
Brief Summary
-----------------
Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several degenerative diseases, including retinopathies and glaucoma, however no previous safety study involving humans has been conducted. The objective of this study is to evaluate effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence tomography, and retinal ganglion cells function.

Official Title
-----------------
Intravitreal Autologous Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Advanced Glaucoma. Phase I: Safety Study.

Conditions
-----------------
Retinal Degeneration, Primary Open-angle Glaucoma

Intervention / Treatment
-----------------
* Procedure: Intravitreal transplantation of mesenchymal stem cell
* Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Advanced Bilateral Open-Angle Glaucoma; Best corrected visual acuity less than 0,1 in the better eye; Social and cognitive ability to participate. Exclusion Criteria: Severe systemic morbidities; Other ocular blind conditions associated; Impossibility in performing any of the proposed examinations.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC transplantion<br>One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eyes, through an unique intravitreal injections, under anesthesia. | Procedure: Intravitreal transplantation of mesenchymal stem cell<br> <br> Biological: Culture and isolation of autologous bone-marrow mesenchymal stem cells<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR) | Retinal detachment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Visual Acuity |  | 6 months | 
| Changes in Visual Field |  | 6 months | 
| Changes in Optical Coherence Tomography Parameters Related to Glaucoma |  | 6 months | 
| Changes in Retinal Ganglion Cells Function by ERG |  | 6 months |
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.

Official Title
-----------------
A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

Conditions
-----------------
Memory Loss

Intervention / Treatment
-----------------
* Drug: Donepezil Hydrochloride
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Memory complaint Mini Mental Status Exam (MMSE) score 24-28 inclusive General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made Generally healthy and ambulatory Sufficiently fluent in English Exclusion Criteria: Diagnosis of probable or possible AD Neurological disorders History of malignant cancers Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Donepezil Hydrochloride<br>* Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Subjects will receive matching placebo tablets.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of cognitive and global function in subjects with MCI. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral, global and cognitive outcomes; Neuroimaging |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive impairment, Memory Loss
A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Study Overview
=================
Brief Summary
-----------------
This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety and Tolerability, of ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

Conditions
-----------------
Diarrhea Predominant Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: ASP7147
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent Men or women aged 18-75 years Patient has IBS with diarrhea (IBS-D) Ability to communicate with the investigator Exclusion Criteria: IBS with constipation (IBS-C) or mixed IBS (IBS-M) Other significant disease or condition that may interfere with trial completion Untreated lactose intolerance History of alcohol or drug abuse in past two years Participation in other clinical trials within prior month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP7147<br>ASP7147, 300 mg, tablet, twice per day for 4 weeks oral | Drug: ASP7147<br>* 300 mg, tablet, twice per day for 4 weeks oral<br>|
| Placebo Comparator: Placebo<br>oral | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain | 10-point pain scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency | Bristol Stool Scale (7-point scale) | 4 weeks | 
| Stool frequency | Number of bowel movements per day | 4 weeks |
A Structured Qi-gong Program for Hospitalized Older Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effects on a number of health outcomes and the feasibility of a structured program of qi-gong, a form of tai-chi which has been previously tested in older populations, in older hospitalized patients. In particular, this pilot study aims to assess changes in quality of life and depressive symptoms after 4 weeks of treatment, with the hypothesis that this intervention will have a positive impact on these two domains, compared to usual care. Adherence will be also monitored in the intervention arm.

Official Title
-----------------
Feasibility and Impact on Quality of Life and Depressive Symptoms of a Structured Qi-gong Program for Hospitalized Older Adults. A Pilot Study.

Conditions
-----------------
Quality of Life, Behavioral Symptoms, Patient Compliance

Intervention / Treatment
-----------------
* Other: qi-gong


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >=50 years old Preserved ability to move inside the house (also using walking aids or chair) Estimation of at least one month of hospitalization (convalescence or rehabilitation) Ability and willing to sign informed consent Exclusion Criteria: Moderate to severe cognitive impairment (SPMSQ >= 4)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: qi-gong<br> | Other: qi-gong<br>* Physical activity similar to tai-chi<br>|
| No Intervention: Usual care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms |  | 4 weeks | 
| Adherence |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity, aging, inpatients, quality of life, depression
Visual Function and Ocular Pigmentation in Albinism

Study Overview
=================
Brief Summary
-----------------
To study the relationship between visual function and ocular (iris, retina/choroidal) pigmentation in patients with albinism and other hypomelanotic disorders. To identify the carrier state in relatives of patients with ocular albinism.

Detailed Description
-----------------
Visual function and ocular pigmentation are being studied in patients with albinism and other disorders associated with hypopigmentation. The degree of ocular pigmentation is assessed clinically by estimating the melanin content of the iris, retinal pigment epithelium, and choroid. Visual function is measured in the conventional manner to study central vision, and electrophysiological methods to detect a misrouting of the visual pathways. The purpose of this study is to document the visual deficit and the pigmentary changes of patients with albinism, to observe their natural course, and to determine whether misrouting of the visual pathways is present and is correlated with pigmentation.

Official Title
-----------------
Visual Function and Ocular Pigmentation in Albinism

Conditions
-----------------
Albinism, Albinism, Ocular, Albinism, Oculocutaneous

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients have been recruited into the study by referral from an ophthalmologist or pediatrician. Entrance into the study was dependent upon clinical evidence of decreased or absent pigmentation in skin, hair, and/or eyes. The definition was purposefully broad to include the broad range of phenotype variations and clinical heterogeneity. The purpose of the study id to be able to document iris and retina/choroidal pigmentation and correlated these finding with visual function.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Albinism, Ocular Albinism, Oculocutaneous Albinism, Tyrosinase Negative, Tyrosinase Positive
A Study of RO4917838 (Bitopertin) in Patients With Persistent, Predominant Negative Symptoms of Schizophrenia (WN25309)

Study Overview
=================
Brief Summary
-----------------
This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

Official Title
-----------------
A Phase III, Multi-center, Randomized, 24 Week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-blind Treatment Period.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: bitopertin [RO4917838]
* Drug: bitopertin [RO4917838]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, aged 18 years and above Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype Predominant negative symptoms With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics) Exclusion Criteria: Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder) Body Mass Index (BMI) of <17 or >40 kg/m2 Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS) A severity score of 3 or greater on the Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: bitopertin [RO4917838]<br>* Oral dose level 1, once a day for 52 weeks<br>|
| Experimental: 2<br> | Drug: bitopertin [RO4917838]<br>* Oral dose level 2, once a day for 52 weeks<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* Oral doses, once a day for 52 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (PANSS negative symptoms factor score) |  | Week 24 | 
| Safety (incidence of adverse events) |  | Week 24 |
Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany

Study Overview
=================
Brief Summary
-----------------
In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.

Official Title
-----------------
Analytical Performance Evaluation of Blood Glucose Monitoring Systems

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: 4 blood glucose monitoring systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Male or female subjects with type 1 or type 2 diabetes or healthy subjects For BG adjustment people with type 1 diabetes Exclusion Criteria: Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness Legal incompetence or limited legal competence Age < 18 years Dependency from the sponsor or the clinical investigator Mental incapacity or language barriers precluding adequate compliance with the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 4 blood glucose monitoring systems|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in accuracy between blood glucose monitoring systems across the overall tested glucose range by comparing the mean absolute value of relative (percent) difference (MARD) between the meter value and the reference value |  | For each subject, the experimental phase has an expected duration of up to 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood glucose monitoring systems, ISO 15197, system accuracy