linjc16/ctgov huggingface dataset:
Feasibility Study of MicroKine Dx System in Critically-ill Pediatric Patients.

Study Overview
=================
Brief Summary
-----------------
This study will enroll approximately 25 pediatric patients to assess the performance and real-world feasibility of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients.

Detailed Description
-----------------
This study will enroll approximately 25 pediatric patients to assess the predictive performance of multi-biomarker based prognostic and predictive algorithms to aid in the clinical management of pediatric critically-ill patients. All enrolled patients will undergo a series of blood collection procedures during their admission to the pediatric intensive care unit. The levels of inflammatory cytokines, chemokines, and effectors will be assessed and used in multi-biomarker based prognostic and predictive algorithms to determine patients at risk of in-hospital mortality.

Official Title
-----------------
An Observational Phase 0 Study to Assess the Performance and Real-world Feasibility of Implementing the MicroKine Dx Biomarker-based Risk Stratification of Critically-ill Pediatric Patients

Conditions
-----------------
Multiple Organ Failure

Intervention / Treatment
-----------------
* Diagnostic Test: MicroKine Dx system


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Age 38 weeks gestation to 21 years of age Admitted to the PICU within the prior 24 hours Indwelling catheters for obtaining blood Meet ≥2 age-adapted SIRS criteria Key Exclusion Criteria: Anticipated pediatric intensive care unit admission <24 hours Primary immunodeficiency Limited resuscitation, no escalation of treatment, do not resuscitate, or other limitations to care Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 38 Weeks
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic inflammatory response syndrome<br>Systemic inflammatory response syndrome in patients in the pediatric intensive care unit. | Diagnostic Test: MicroKine Dx system<br>* Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 28-day in hospital mortality | 28-day |
Ability to Drive of Early Stage Alzheimer Disease

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are: To evaluate the driving capacities in a population of elderly subjects with early stage Alzheimer Disease (AD) in a real-life situation. Define a typology of the main errors made in this population. Propose adaptive measures or technological aids that would make it possible for these patients to maintain their ability to drive a car while limiting risk.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Other: Assessment of drive abilities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The following subjects will be included and classified as  patients  : Age > 70 years With established diagnosis of Alzheimer's disease as defined by DSM IV With MMSE score ≥ 24 (early-stage Alzheimer's disease) Holder of a valid driving license With regular driving activity (drives at least once per week) Informed consent provided. The following subjects will be included and classified as  controls  : Age > 70 years, Absence of cognitive impaired that interferes with their daily life at initial evaluation, Holder of a valid driving license, With regular driving activity (drives at least once per week), Informed consent provided. Exclusion Criteria: Dementia syndrome(s) other than Alzheimer's disease, MMSE score < 24 Informed consent not provide

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Assessment of drive abilities|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease

Study Overview
=================
Brief Summary
-----------------
Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD).

Official Title
-----------------
Expanded Access Protocol for Emergency Use of REGN3470-3471-3479 for the Treatment of Ebola Virus Disease

Conditions
-----------------
Ebola Virus Disease

Intervention / Treatment
-----------------
* Biological: REGN3470-3471-3479


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Males or females in an Ebola endemic region with documented positive polymerase chain reaction (PCR) for Ebola virus infection who are symptomatic Ability to provide informed consent personally or by a legal representative if the patient is unable to do so, based on local laws and regulations REGN-EB3 can be administered to pregnant women infected with Zaire ebolavirus, as defined in the protocol Children of any age will be eligible for enrollment, as defined in the protocol Neonates born to an infected mother who has not yet cleared the Ebola virus are eligible for enrollment, as defined in the protocol Key Exclusion Criteria: Negative EBOV diagnostic test result A patient who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol Any serious medical condition that, in the opinion of the site investigator, would place the patient at an unreasonable increased risk through participation in this study, including any past or concurrent conditions Eligible for an ongoing randomized clinical trial with REGN-EB3 NOTE: Other protocol defined inclusion / exclusion criteria apply
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: REGN3470-3471-3479|nan|

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
-----------------
Positive Ebola Virus (EBOV) diagnostic test, symptomatic
Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate the appropriate condition of developing cultivated corneal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated corneal epithelial stem cell in the patients.

Detailed Description
-----------------
Ocular surface damage caused by severe ocular surface diseases, particularly thermal and chemical burn or Stevens-Johnson syndrome result in corneal epithelial defect, corneal vascularization, corneal conjunctivalization and loss of transparency. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications.

Official Title
-----------------
Efficacy of Cultivated Corneal Epithelial Stem Cell for Ocular Surface Reconstruction

Conditions
-----------------
Severe Ocular Surface Damage, Limbal Deficiency

Intervention / Treatment
-----------------
* Procedure: Cultivated limbal transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral/Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology result Exclusion Criteria: Age under 18 Active ocular infection, Severe dry eye, Uncontrolled glaucoma Immunocompromised host Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cultivated limbal transplantation<br> | Procedure: Cultivated limbal transplantation<br>* Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface status (signs of limbal deficiency and immunopathological markers) |  | Three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular surface damage, Limbal deficiency, Cultivated corneal epithelial stem cell transplantation
The Role of Genetic Factors in the Development of Epilepsy in the Kazakh Population

Study Overview
=================
Brief Summary
-----------------
This is a GWAS study that aims to identify possible candidate genes associate to epilepsy by exploring single nucleotide polymorphism (SNP) in a group of epilepsy, in the Kazakh population. The investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find SNP significantly associate with epilepsy

Detailed Description
-----------------
A genome-wide association study (GWAS) is an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies

Official Title
-----------------
Preventive and Personalized Medicine (2021-2023)

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Genetic: DNA analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with seizures, confirmed by EEG and no morphological damage to the brain, confirmed by MRI of the brain; The age of the patients is from 0 to 5 years; Persons of Kazakh nationality, whose paternal and maternal grandparents are Kazakhs; Children are parents or legal guardians who have given written informed consent. Exclusion Criteria: Children over 5 years old; Children whose parents, according to the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; Children with seizures with brain damage that cause epilepsy; Children of a non-Kazakh ethnic group.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 5 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group:<br>Patients with epilepsy | Genetic: DNA analysis<br>* GWAS<br>|
| Control group<br>Patients without epilepsy | Genetic: DNA analysis<br>* GWAS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of SNPs associated with epilepsy | Using GWAS to identify candidate genes associate with epilepsy | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GWAS
Anesthetic Requirement and Stress Hormone Response During Surgery in Spinal Cord-injured Patients

Study Overview
=================
Brief Summary
-----------------
Spinal cord injury (SCI) reduces anesthetic requirements and stress hormonal responses. Anesthetic requirements and stress hormone response are compared in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil.

Detailed Description
-----------------
Nitrous oxide (N2O) is often used for anesthetic adjuvant, but may be associated with side effects and toxicities. Remifentanil shares characteristics with N2O, including anesthetic-reducing and antinociceptive effects and a rapid recovery. Anesthetic requirements and stress hormone response in SCI patients undergoing anesthesia with sevoflurane supplemented with clinically equivalent doses of either N2O or remifentanil. Forty-five SCI patients scheduled to undergo pressor sore surgery below the level of the injury are randomly allocated to receive either sevoflurane alone (control, n=15), or combined with 67% N2O (n=15) or target-controlled infusions of 1.37 ng/mL remifentanil (n=15). Sevoflurane concentration is titrated to maintain a Bispectral Index (BIS) value of 40-50. Measurements include end-tidal sevoflurane concentrations, mean arterial blood pressure (MAP), heart rate (HR), and plasma catecholamine and cortisol concentrations.

Official Title
-----------------
Chonnam National University Hospital IRB

Conditions
-----------------
Complete Spinal Cord Injury, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status II, with chronic, clinically complete cord injuries scheduled for a surgery for pressure sore below the level of the neurologic lesion under general anesthesia. Exclusion Criteria: Cardiovascular, pulmonary, or metabolic diseases. Patients who took medications that would influence autonomic or cardiovascular responses to the surgery

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 Years

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
-----------------
spinal cord injury, stress hormone, surgery, bispectral index value, volatile anesthetic
Action Medical Research

Study Overview
=================
Brief Summary
-----------------
Learning disability affects 3% of the population. Severe types of learning disability are more likely to have an underlying genetic cause but diagnosis is difficult because many different genetic abnormalities may be involved. Obtaining a diagnosis is important so that patients can be managed appropriately and their families can be given accurate information. We aim to use new types of genetic testing which will make it possible to screen for several different genetic abnormalities which cause learning disability at the same time, so improving the accuracy and speed of diagnosis in the group of patients with severe learning disability. We will focus particularly on patients where seizures and behavioural problems are also present.This will enable more patients to be diagnosed accurately, reduce the number of hospital appointments needed and ultimately be more cost- effective.

Official Title
-----------------
Using New Genetic Technology to Diagnose Neurodevelopmental Disorders

Conditions
-----------------
Learning Disabilities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with severe learning disability associated with either seizures, movement or behaviour problems who had previously undergone routine investigation but where no cause had been identified for their problems Exclusion Criteria: Individuals with SLD where the cause is already known Individuals where informed consent cannot be obtained for participation
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Microarray / NGS test<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic abnormality identified by microarray or Next Generation Sequencing | Abnormalities identified upon results of testing, the normal timeframe for this is up to 6 months after collecting blood sample. | up to 6 months following consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness vs normal care | This analysis will be performed for all participants following close of recruitment & follow up, and will be completed by the time the study ends. | By the end of the study (December 2014) |
Application of hybridAPC in the Treatment of Barrett

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of the new technique of HybridAPC in the treatment of Barrett.

Detailed Description
-----------------
After thermal ablation of Barrett's esophagus, stricture formation is reported in 5 to over 10% of patients. Submucosal fluid injection prior to ablation may lower the risk of stricture formation. The new technique of HybridAPC which combines submucosal injection with APC is considered to reduce the complication.

Official Title
-----------------
Application of hybridAPC in the Treatment of Barrett: a Multicenter, Prospective Study

Conditions
-----------------
Barrett's Esophagus

Intervention / Treatment
-----------------
* Device: HybridAPC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age is from 18 to 70. Patients who were diagnosed with Barrett's esophagus. Informed consent. Exclusion Criteria: Patient with severe cardiopulmonary dysfunction is unable to tolerated by endoscopy. Severe bleeding tendency. Poor compliance. Patient is very ill and life expectancy is less than 2 years. Esophageal varices or venous aneurysms, and no effective prevention or treatment for bleeding. Severe esophageal stenosis. Pregnancy. Lesion is located in esophageal diverticulum or spread their diverticulum.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: HybridAPC<br>The patient with Barrett's esophagus is treatment by HybridAPC. | Device: HybridAPC<br>* HybridAPC is a device which combines submucosal fluid injection with APC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radical rate | Radical rate was defined as it that after 3 months of treatment, the primary lesion area returning to normal is reconfirmed by pathological diagnosis. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence | Recurrence was defined as it that after 3 months of treatment, Barrett's esophagus is reconfirmed by pathological diagnosis in the primary lesion again. | 3 months | 
| adverse event | Adverse event was defined as any device treatment-related adverse event such as bleeding and perforation | 1 year | 
| operation time | Operation time was defined as the time from the beginning of submucosal injection to the final end of ablation. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barrett Esophagus, argon plasma coagulation, submucosal injection
Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study

Study Overview
=================
Brief Summary
-----------------
12-week, open-label study of topiramate in hospitalized patients with alcoholism

Official Title
-----------------
Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: Topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized due to alcohol-related problems DSM-IV-TR alcohol dependence >/= 35 drinks/week (male) or >/= 28 drinks/week (female) for >/= 1 week during four weeks prior to the admission AUDIT score >/= 8 Mild or no alcohol withdrawal Body mass index > 18 kg/m2 No pregnancy and no plan for pregnancy (female) Intention to decrease or stop drinking Exclusion Criteria: Severe psychiatric and cognitive disorders Other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment Taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram Moderate to high risk of suicide Medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures Unstable medical conditions Plan to receive a formal treatment for alcoholism from other treatment settings Under legal process Pregnancy and nursing woman Abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Topiramate<br>1 group | Drug: Topiramate<br>* Topiramate 50-300 mg/day Orally Twice per day<br>* Other names: Topamax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition | Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol drink/day | Alcohol drink/day assessed by the use of Timeline Followback (TLFB) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol dependence, Alcoholism, Topiramate