linjc16/ctgov huggingface dataset:
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia

Study Overview
=================
Brief Summary
-----------------
Small Incision Lenticule Extraction (SMILE) was introduced in 2011 using the VISUMAX femtosecond laser (Carl Zeiss Meditec, Jena, Germany). It is designed for correction of myopia and myopic astigmatism. It involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. This enables rapid visual recovery with very little discomfort to the patient. This observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 D. It is to gather long-term results and refractive stability detect rare complications or side-effects evaluate the efficacy in a large number of patients

Official Title
-----------------
Clinical Results of Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia

Conditions
-----------------
Myopia, High Myopia

Intervention / Treatment
-----------------
* Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults myopia more than -7.75 D refractive stability more than 1 year Exclusion Criteria: corneal irregular astigmatism ectatic conditions

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>SMILE - Correction of eyes with myopia of more than -7.75 D | Other: Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)<br>* Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser<br>* Other names: RelaxSmile;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Distance Refraction | Subjective Refraction | 1 year | 
| Distance Visual Acuity | Visual Acuity sine and cum correctione | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tectonic stability as assessed by Pentacam | Corneal tectonic stability post surgery as assesed by Scheimpflug-Tomography | 1 year | 
| Epithelial thickness map in Optical coherence tomography | Change of Thickness of epithelium pre and post surgery | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Refractive Surgery, Small Incision Lenticule Extraction, SMILE
Diabetes Treatment With Glucobay in Combination With Sulfonylurea

Study Overview
=================
Brief Summary
-----------------
In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of sulfonylurea under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing sulfonylurea therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The Post Marketing Survelliance study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.

Official Title
-----------------
Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Sulfonylurea Under Daily Life Treatment Conditions

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Acarbose (Precose/Glucobay, BAYG5421)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patient with type 2 diabetes with one of the following treatment ongoing : 1) Sulfonylurea 2) Sulfonylurea + OHA. In such patients, if investigator feels that addition of acarbose would be benficial for the patients Exclusion Criteria: According to local product information

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Group 1<br> | Drug: Acarbose (Precose/Glucobay, BAYG5421)<br>* Oral Glucobay 25 titrated to Glucobay 50 upto three times a day with meals or as per investigators descretion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection on body weight |  | 16 weeks | 
| Data collection on blood glucose |  | 16 weeks | 
| Data collection on Hba1c |  | 16 weeks | 
| Data collection on pre treatment concomitant diseases |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables will be summarized using descriptive statistics based on adverse events collection |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Type-2, Acarbose, Drug Therapy, Combination
Correlation Between Cognitive Functions and MRI in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is a correlation between cognitive functions and volume of specific brain area measured in MRI of multiple sclerosis patients.

Detailed Description
-----------------
Recent literature suggests that multiple sclerosis is accompanied by significant deficits in cognitive performance. The origin of these cognitive deficits is not known, since the severity of cognitive deficits was not found to be correlated with disease parameters such as duration, lesion load or disease intensity as measured on standard scales (e.g. EDSS). The research hypothesis we plan to test is that the individual intensity of cognitive deficits is correlated with degeneration of specific neuronal structures related to cognitive performance, such as the hippocampus and prefrontal cortex. To test this hypothesis, we plan to perform volumetric measurements of such regions on MRI scans obtained from MS patients during the course of their clinical evaluation, and attempt to correlate those with the results of neuropsychological tests performed by the same subjects around the time of MRI scanning.

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Multiple Sclerosis Age 18-65 Exclusion Criteria: Another brain disease Stroke Brain trauma Neurosurgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
-----------------
Memory, Multiple sclerosis, Cognitive deficits, MRI, Hippocampus, Prefrontal cortex
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)

Study Overview
=================
Brief Summary
-----------------
Study to demonstrate that administration of Venticute increases survival of patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygenation impairment.

Official Title
-----------------
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents Leading to Intubation, Ventilation, and Severe Oxygenation Impairment: A Randomized, Multinational, Multicenter, Parallel Group, Double Blind, Control Group Study

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: Venticute


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: Patient has been intubated due to one of the following primary pulmonary insults: aspiration of gastric contents or pneumonia Main exclusion criteria: Principal source of infection or sepsis is outside the lung Severe pre-existing lung disease Cancer metastatic to the lung or any end stage malignancy History of lung, liver, pancreas, small bowel, or bone marrow/stem cell transplantation Patient is morbidly obese Patient has a diagnosis of acute necrotizing pancreatitis Additional criteria may apply and examination by an investigator is required to determine eligibility.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Drug: Venticute|Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival on day 28 |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How long the lung and the patient (overall) are recovering |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aspiration of gastric contents
Biomarkers of Acute Kidney Injury in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) is the most common complication in patients after cardiac surgery. An usual estimation of risk for AKI is estimation of serum creatinine, which is unreliable indicator of AKI risk. Because of that, today different biomarkers are investigated to predict incidence for development AKI after cardiac surgery. This investigation will try to find potentially risk patients for developing AKI after cardiac surgery by using conventional markers (creatinine, glomerular filtration rate) in perioperative period comparing with two different biomarkers neutrophil gelatinase-associated lipocalin (NGAL) and growth differentiation factor 15 (GDF-15) which are proven markers in patients with increased risk for AKI development.

Official Title
-----------------
Biomarkers in Estimation for Risk of Acute Kidney Injury in Cardiac Surgery

Conditions
-----------------
Acute Kidney Injury (Nontraumatic)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for cardiac surgery (CABG, valve replacement/repair, combined) older than 18 years Exclusion Criteria: previous known renal disease patients on chronic dialysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consecutive values of neutrophil gelatinase-associated lipocalin (NGAL) | By the changing of NGAL values in consecutive measuring, predict which patients are in increased risk for development of AKI | One year | 
| Consecutive values of growth differentiation factor 15 (GDF-15) | By the changing of GDF-15 values in consecutive measuring, predict which patients are in increased risk for development of AKI | One year | 
| Consecutive values of glomerular filtration rate (GFR) | By the changing of GFR values in consecutive measuring, predict which patients are in increased risk for development of AKI | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute kidney injury, Cardiac surgery, NGAL, GDF-15
HCU: Can VHVs Trained in ICCM Improve Care for Children

Study Overview
=================
Brief Summary
-----------------
This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children. In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?

Official Title
-----------------
Healthy Child Uganda: Can Village Health Volunteers Trained in Integrated Community Case Management of Childhood Illness Improve Access to Care for Africa's Most Vulnerable Children?

Conditions
-----------------
Diarrhoea, Pneumonia, Malaria

Intervention / Treatment
-----------------
* Other: Training of VHVs in iCCM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women living in intervention and comparison villages Mother to at least one child under 59 months old Exclusion Criteria: -No living child
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training of VHVs in iCCM<br>In these villages VHVs will be provided with iCCM training and equipped to support iCCM in their villages | Other: Training of VHVs in iCCM<br>* Village Health Volunteers will be trained in Integrated Community Case Management (iCCM) of childhood illness<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia |  | pre- (Dec 2010) post- (Dec 2012) intervention (2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antimalarials, Antibiotics, ORS Zn, Village Health Volunteers, Integrated Community Case Management
Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis

Study Overview
=================
Brief Summary
-----------------
Vocal cord paralysis is a common cause of congenital stridor and airway obstruction. In this study we plan to identify the genetic locus of the genes in two extended families who suffer of the disease.

Detailed Description
-----------------
In a number of families suffering of familial vocal cord paralysis it has previously been shown that the disease is inherited autosomal dominant. In one of the families the gene coding for the disease was located on chromosome 6q16. We will be analyzing 2 extended families with familial vocal cord paralysis to define their genetic defect leading to the disease. All family members will undergo a laryngoscopy to determine the extent of paralysis. For all family members we will isolate DNA and determine their microsatellite polymorphism on chromosome 6q16. If the results are negative we will continue the study and perform a whole genome scan to localize the gene(s) involved.

Official Title
-----------------
Whole Genome Scan of Extended Families With Familial Vocal Cord Paralysis

Conditions
-----------------
Vocal Cord Paralysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: members of families suffering of familial vocal cord paralysis Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 10 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
-----------------
familial vocal cord paralysis, genetic screening
The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19

Study Overview
=================
Brief Summary
-----------------
During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine. The restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us. A knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the burn-out of doctors struck by the health crisis.

Official Title
-----------------
The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19

Conditions
-----------------
COVID-19 Pandemic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged over 18; Entering the neurosurgery care sector requiring support between 03/16/2020 and 06/15/2020; Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion Criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospective analysis of the management of neurosurgical pathologies in a health crisis situation of the Covid-19 pandemic |  | The files analysed retrospectily from March 16, 2020 to June 15, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 Pandemic, Coronavirus, Sars-cov-2
Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan

Study Overview
=================
Brief Summary
-----------------
The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.

Detailed Description
-----------------
Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.

Official Title
-----------------
Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan and Potential Impact on ICD Implant Rates for Primary Prevention of Sudden Cardiac Death (SAVE-ICD)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Diagnostic Test: two-dimensional echocardiogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart failure left ventricular systolic dysfunction carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death undergoing therapy with Sacubitril/Valsartan according to current Guidelines Exclusion Criteria: age <18 years

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: two-dimensional echocardiogram|two-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in left ventricular ejection fraction | Difference between the ejection fraction observed at baseline and that observed at 6 months of follow-up | at enrollment and at 6 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in left ventricle volumes | Difference between the left ventricle volumes measured at baseline and those measured at 6 months of follow-up | at enrollment and at 6 months of follow-up |