linjc16/ctgov huggingface dataset:
Eye Rubbing and Keratoconus in Montpellier CHU

Study Overview
=================
Brief Summary
-----------------
Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction habits

Official Title
-----------------
Assessment of the Lived Experience of the Disease of the Patients Followed at the CHU of Gui de Chauliac for a Keratoconus and Their Habit of Eye Rubbing

Conditions
-----------------
Keratoconus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Having a keratonus at least in one eyes Exclusion criteria: - Refus to participate
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 |
| --- | --- | --- |
| Assess whether eye rubbing is a risk factor for keratoconus | Assess whether eye rubbing is a risk factor for keratoconus | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the habits of the population with a keratoconus | Evaluate the habits of the population with a keratoconus by a questionnaire completed by the patient | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primitive corneal ectasia, Ophthalmology, Eyes rubbing, Keratoconus
Patterns of Injury and Mortality in Free-fall Trauma Patients

Study Overview
=================
Brief Summary
-----------------
In this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a Taiwan level one trauma center.

Detailed Description
-----------------
Falls from height is the leading cause of accidental deaths. The mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area…etc. Most victims presented to emergency department with major trauma, so initial evaluation and timely management are crucial for the survival. The knowledge of unique pattern of injuries helps clinicians to facilitate the diagnosis. In this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a Taiwan level one trauma center.

Official Title
-----------------
Patterns of Injury and Mortality in Free-fall Trauma Patients

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with free-fall trauma Exclusion Criteria: adult patients with free-fall trauma, not relating with traffic accidents

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|only retrospective reviews for medical records|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patterns of injury and causes of mortality | patterns of injury and causes of mortality in free-fall patients | one month |
Treatment for Patients With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study the efficacy and safety of AMG 073 in patients with kidney failure who are being treated with hemodialysis or peritoneal dialysis and who also have secondary hyperparathyroidism (HPT).

Official Title
-----------------
A Study to Compare the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) When Two Different Vitamin D Regimens Are Used in Subjects With Secondary Hyperparathyroidism of End-Stage Renal Disease (ESRD)

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: AMG 073


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Completed one of the qualifying studies (i.e., patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) - Must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study Exclusion Criteria: - Pregnant or nursing females - Experienced a myocardial infarction within 3 months before day 1 - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AMG 073|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine PTH and Ca x P control when cinacalcet is administered in the setting of flexible dosing of vitamin D sterols. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine safety and tolerability of cinacalcet. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sensipar®, Secondary HPT, Mimpara®, Cinacalcet, calcimimetic, End-Stage Renal Disease (ESRD)
Visual Perception Exploration Using Eye-tracking Technology in High-fidelity Medical Simulation

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to compare the visual interests between residents in high-fidelity simulation practice

Detailed Description
-----------------
Eighteen first year residents were asked to take part in a nine-minute scenario based on an ACLS bradycardia algorithm in which a high-fidelity mannequin required external pacing. The scenario was considered a success if the material was correctly set by the participant to obtain electrical and mechanical pacing in nine minutes. All participants were wearing Tobii Glasses® which is a mobile eye-tracking system that automatically aggregates gaze data. Infrared markers were placed in the simulation room to create Area of Interest (AOI), from which results were obtained. Three AOI were created: the vital signs monitor, the defibrillator/pacing unit and the head of the patient. Eye-tracking data were analyzed using the Tobii Studio® program.

Official Title
-----------------
Visual Perception Exploration Using Eye-tracking Technology in High-fidelity Medical Simulation

Conditions
-----------------
Simulation Training, Perception, Eye Movements, Task Performance and Analysis

Intervention / Treatment
-----------------
* Behavioral: Simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-year residents from various specialties in their first three weeks of training Exclusion Criteria: Underwent a previous residency Attending physicians in another country
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 |
| --- | --- |
| Success at the simulation<br>Participant could correctly set the pacing unit to obtain electrical and mechanical pacing of the mannequin in nine minutes. | Behavioral: Simulation<br>* A 9-minute scenario based on an ACLS bradycardia algorithm in which a high-fidelity mannequin requires external pacing<br>|
| Failed the simulation<br>Participant could not correctly set the pacing unit to obtain electrical and mechanical pacing of the mannequin in nine minutes. | Behavioral: Simulation<br>* A 9-minute scenario based on an ACLS bradycardia algorithm in which a high-fidelity mannequin requires external pacing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first fixation, Total visit time | Using eye-tracking technology, gaze date can be aggregate onto Areas of interest where data can be extrapolated. | During the scenario | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye-tracking, Visual Perception, High Fidelity Simulation Training
An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.01%
* Drug: travatan 0.004%
* Drug: timolol 0.5%
* Drug: hypromellose 0.3%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular hypertension or glaucoma that requires treatment with medication Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes Exclusion Criteria: History of LASIK, LASEK, RK, and/or PRK in the study eye(s) History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bimatoprost 0.01% and hypromellose 0.3%<br>Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks. | Drug: bimatoprost 0.01%<br>* Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.<br>* Other names: Lumigan®;Drug: hypromellose 0.3%<br>* Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.<br>* Other names: GenTeal®;|
| Active Comparator: travatan 0.004% and timolol 0.5%<br>Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks. | Drug: travatan 0.004%<br>* Travatan 0.004% administered to both eyes once daily for 12 weeks.<br>* Other names: Travatan Z®;Drug: timolol 0.5%<br>* Timolol 0.5% administered to both eyes once daily for 12 weeks.<br>* Other names: Timolol GFS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM | IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements. | Week 12 at 8 AM, 12 PM, and 4 PM |
Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients

Study Overview
=================
Brief Summary
-----------------
This observational (non-interventional) post-authorization safety study (PASS) will investigate the application of Venofundin 6% and of Tetraspan 6% in children with special regard to drug safety.

Official Title
-----------------
Infusion of Venofundin 6% or Tetraspan 6% in Paediatric Patients Aged up to 12 Years

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤12 years Risk of anaesthesia: American Society of Anaesthesiologists (ASA) risk score: I - III infusion of Venofundin 6% or of Tetraspan 6% elective intervention Exclusion Criteria: contraindications according to SmPC

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- |
| HES 130 / 0.42<br>paediatric patients aged up to 12 years requiring non-emergency volume replacement therapy with HES 130/0.42 | Drug: HES 130 / 0.42 (Venofundin 6%, Tetraspan 6%)<br>* solution for intravenous infusion applied according to SmPC<br>* Other names: Venofundin 6%, Tetraspan 6%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adverse events |  | peri-operative |
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to identify persons with rapid-onset dystonia-parkinsonism (RDP) or mutations of the RDP gene, document prevalence of the disease, and map its natural history.

Detailed Description
-----------------
Rapid-onset dystonia-parkinsonism (RDP) is a rare, movement disorder with variable characteristics ranging from sudden onset (hours to days) of severe dystonic spasms to gradual onset of writer's cramp. RDP has elements of both dystonia and Parkinson's disease-two neurological diseases with motor and neuropsychological symptoms that hinder the quality of life. An internal trigger associated with extreme physiological stress has been reported prior to abrupt symptom onset of RDP. This study, which is a continuation of an earlier study begun by Dr. Allison Brashear, aims to more clearly identify the characteristics associated with RDP and to explore whether mutations in the RDP gene are associated with atypical dystonias, Parkinson's disease, and other movement disorders. The study involves in-person or remote (telemedicine) neurological assessments and blood samples for genetic analysis.

Official Title
-----------------
Clinical, Genetic, and Cellular Consequences of Mutations in the NA,K-ATPase ATP1A3

Conditions
-----------------
Dystonia, Parkinsonism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical presentation consistent with ATP1A3 disease (RDP, AHC) or confirmed diagnosis of RDP or AHC Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ATP1A3 Mutation<br>Those with RDP, AHC, unaffected carriers of ATP1A3 mutations, and non-carrying family members | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDP Severity | History of symptom onset and duration will be obtained and current degree of severity assessed. | Visit 1 (baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of neuropsychiatric disease | Psychiatric interview and cognitive assessment will be performed to examine presence or absence of symptoms. | Will be assessed at Visits 1 (baseline) and 2 (24 months), approximately 2 years apart | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dystonia, parkinsonism, rapid-onset dystonia-parkinsonism, RDP, Alternating Hemiplegia of Childhood, AHC
Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis

Study Overview
=================
Brief Summary
-----------------
we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis.

Detailed Description
-----------------
Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is widely used for the treatment of peripheral vascular occlusive disorders. In addition, PTX has shown its ability to attenuate nephrotic syndrome secondary to membranous glomerulonephritis and lupus nephritis, and to reduce subnephrotic proteinuria due to early and advanced diabetic nephropathy. However, data with respect to its effect on non-nephrotic primary glomerular diseases are lacking. Moreover, while the anti-proteinuric effect of PTX has been largely attributed to down-regulation of TNF-a, it remains unknown whether other mediators, especially MCP-1, are also affected by PTX. Because our previous works have shown that PTX attenuates proteinuria and suppresses renal MCP-1 mRNA expression in experimental glomerulonephritis in rats, we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis. This study was thereby conducted to investigate the potential anti-proteinuric and anti-MCP-1 effects of PTX in subnephrotic patients with primary glomerular diseases.

Official Title
-----------------
Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis

Conditions
-----------------
Primary Glomerulonephritis

Intervention / Treatment
-----------------
* Drug: pentoxifylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glomerular diseases with subnephrotic proteinuria Exclusion Criteria: DM, hepatitis, systemic immunologic renal diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pentoxifylline|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory mediators |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glomerulonephritis
Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

Study Overview
=================
Brief Summary
-----------------
Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.

Official Title
-----------------
Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .

Conditions
-----------------
Acute Gastroenteritis

Intervention / Treatment
-----------------
* Drug: Gelatin Tannate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children < 5 years old diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days inform consent sign Exclusion Criteria: regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission underlying gastrointestinal tract disorder presenting with diarrhea breastfeeding >50% malnutrition (weight/high <3pc)

Ages Eligible for Study
-----------------
Maximum Age: 5 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gelatin Tannate<br>Gelatin Tannate: 4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years. | Drug: Gelatin Tannate<br> <br> |
| Placebo Comparator: Placebo<br>Placebo consists of an identical formulation, except active substance. | Drug: Placebo<br>* Placebo consists of an identical formulation, except active substance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea | time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of intravenous rehydration due to diarrhea |  | 7 days | 
| Need of hospitalization in outpatients |  | 7 days | 
| Vomiting |  | How many times for 7days | 
| Weight gain |  | 7 days | 
| Diarrhea recurrence |  | 7 days | 
| Frequency of watery stools |  | 7 days | 
| Adverse effects |  | 7 days | 
| Severity of diarrhea due to modified Vesikari score |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diarrhea, gelatin tannate, acute gastroenteritis