linjc16/ctgov huggingface dataset:
Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

Study Overview
=================
Brief Summary
-----------------
The purpose of studyis to compare the efficacy of phenytoin with levetiracetam for the management of children with status epilepticus.Study performa consists of demographic variables,exclusion criteria,history of epilepsy and efficacy achieved or not.

Detailed Description
-----------------
After getting informed consent 244 children with status epilepticus will be randomly classified into two groups.one group will receive levetireacetam and other group will be given phenytoin and their efficacy will be compared by observing them for breakthrough fits for next 48 hours.

Official Title
-----------------
Comparison of Efficacy of Phenytoin With Levetireacetam for the Management of Children With Status Epilepticus

Conditions
-----------------
Status Epilepticus

Intervention / Treatment
-----------------
* Drug: intravenous levetireacetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: childen of age less than 12 years either gender admitted in pediatric emergency with status epilepticus Exclusion Criteria: children already taking either of trial drug or failed treatment with either of trial drug.children with comorbid conditions

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 12 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous levetireacetam<br>Drug:Intravenous levetireacetam will be given at a loading dose of 20-30mg/kg then it will be added in maintainance dose of (5-30mg/kg/day) | Drug: intravenous levetireacetam<br>* phenytoin is considered as control drug in the study<br>|
| Experimental: intravenous phenytoin<br>Intravenous phenytoin will be given in loading dose of 20mg/kg then it will be added in maintainance dose i-e 5-8mg/kg/day | Drug: intravenous levetireacetam<br>* phenytoin is considered as control drug in the study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of efficacy of levetireacetam with phenytoin for the management of children with status epilepticus | the intervention will be considered efficacious if child will not have breakthrough fits for 48 hours | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
status epilepticus, children, phenytoin, levetireacetam
An Evaluation of the Safety of CSF-1 in Presbyopic Subjects

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, double-masked, vehicle-controlled study. The purpose of the study is to evaluate the safety of CSF-1 compared with vehicle in presbyopic subjects. Subjects will be treated for at least 6 weeks.

Official Title
-----------------
A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Safety of CSF-1 in Presbyopic Subjects

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Drug: CSF-1
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have presbyopia Exclusion Criteria: Have any contraindications to the study medications or diagnoses that would confound the study data

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 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: CSF-1<br>One drop bilaterally twice daily for approximately 6 weeks | Drug: CSF-1<br>* One drop bilaterally twice daily for approximately 6 weeks<br>|
| Placebo Comparator: Vehicle<br>One drop bilaterally twice daily for approximately 6 weeks | Drug: Vehicle<br>* One drop bilaterally twice daily for approximately 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment emergent adverse events. |  | Week 6 |
Dermacyd Infantile - Acceptability.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To prove the safety of the formulation in normal conditions of use.

Official Title
-----------------
Safety Dermatological Evaluation: Acceptability With Paediatric Follow up Dermacyd Infantile (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Integral skin test in the region Use the same category of cosmetics Willingness in following the study procedures and to be present in the clinic at the days and scheduled time. Exclusion criteria: Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs Allergic or atopic history to cosmetics products Cutaneous active disease (local or general) in the evaluated area Disease which can cause immunosuppressant, such as diabetes, HIV Endocrine pathology Intensive solar exposure until 15 days before evaluation Treatment four months before selection. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd infantile (Lactic Acid)<br>treatment duration 21 consecutive days | Drug: LACTIC ACID(ND)<br>* Dermacyd Infantile (LACTIC ACID)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction. |  | From the treatment start to the end of the study |
Japanese Catheter Ablation Registry

Study Overview
=================
Brief Summary
-----------------
Japanese Cather Ablation (J-AB) Registry is a voluntary nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The objectives of this registry are to observe and describe developments in the catheter ablation treatment of arrhythmia in Japan and to provide reliable information on the type of activity performed and the facilities available in Japanese arrhythmia units.

Detailed Description
-----------------
Japanese Cather Ablation (J-AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system. Detailed data collection including antiarrhythmic medication is also performed at every September. The acute success rate at discharge and the complications associated with ablation procedure will be collected in all cases. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

Official Title
-----------------
Japanese Catheter Ablation Registry

Conditions
-----------------
Catheter Ablation, Cardiac Arrhythmias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with catheter ablation in Japan Exclusion Criteria: Patients who refused to consent
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 |
| --- | --- | --- |
| Number of patients with recurrence of targeted arrhythmia |  | Through discharge from hospital, approximately up to 1 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of deaths | All-cause death, cardiovascular death, and procedure-related death | Through discharge from hospital, approximately up to 1 weeks | 
| Number of patients with treatment-related complications | Bleeding events, embolic events, other all complications. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheter Ablation, Cardiac Arrhythmias, Registry, Complication, REDCap
The Association of G9a Protein and the Outcome of Patients With Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
G9a protein was approved to be highly associated with recurrence of breast cancer, gastric cancer, hepatocellular cancer, prostate cancer and lung cancer. Therefore, the aim of this study was to clarify the association and G9a protein and cervical cancer by analyzing the immunohistochemical staining of G9a protein to the histopathologic specimen of cervical cancer and clinical data.

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases with cervical cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cervical cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine whether G9a protein is a risk factor of overall survival of patients with cervical cancer |  | From the date of primary treatment until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine whether G9a protein is a risk factor of progression-free survival of patients with cervical cancer |  | From the date of primary treatment until the date of first documented progression or last follow-up, whichever came first, assessed up to 100 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Outcome of cervical cancer
Sorbent Therapy of the Cutaneous Porphyrias

Study Overview
=================
Brief Summary
-----------------
The investigators demonstrated that cholestyramine is an effective binding agent in vitro for porphyrins. A few isolated case reports of treatment of individuals with a cutaneous porphyria suggest that cholestyramine and colestipol effectively remove porphyrins. Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).

Detailed Description
-----------------
Four adults with proven EPP volunteered as subjects for this study. First period: Subjects received 1 gm colestipol twice daily for  45 days, then 2 gm twice daily for  45 days. Labs included CBC; liver chemistries including cholesterol; serum iron, TIBC and ferritin; erythrocyte and plasma protoporphyrin concentrations; and completion of sun exposure questionnaire focused on cutaneous manifestations every 2-4 weeks. Second period: Subjects received colestipol tablets, 2 grams twice daily, completing the sun exposure questionnaire and protoporphyrin determinations  monthly for 5-6 months.

Official Title
-----------------
Sorbent Therapy of the Cutaneous Porphyrias

Conditions
-----------------
Erythropoietic Protoporphyria

Intervention / Treatment
-----------------
* Drug: Colestipol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult over age 21 healthy Exclusion Criteria: Intercurrent illness pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 60 Years

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

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

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: colestipol treatment<br>2 grams morning and bedtime for 180 days | Drug: Colestipol<br>* 2 grams morning and bedtime for 90 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance | Minutes of sun tolerance | At 60 days of treatment | 
| Protoporphyrin Concentration in Blood | erythrocyte protoporphyrin concentration, ug/dl plasma protoporphyrin concentration, ug/dl | Samples collected while on treatment (range 93-208 treatment days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sorbent, Resin, EPP, Cutaneous porphyria, Adult, over age 21, without intercurrent illness, not pregnant, willing to participate
Changes in Brain Tissue Pulsatility With Musical Stimuli

Study Overview
=================
Brief Summary
-----------------
Music Perception is well known to elicit emotions and neuronal activations. Changes in the cerebrovascular physiology have also been found in emotional tasks but only few studies have investigated markers of cerebrovascular physiology in a music task and no study has used the Ultrasound method of Tissue Pulsatility Imaging (TPI) in a music task. The use of TPI to measure reactivity of Brain Tissue Pulsatility Imaging (BTP) could further elucidate the cerebral basis of music perception.

Official Title
-----------------
Changes in Brain Tissue Pulsatility With Musical Stimuli

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more or equal 18 years-old and less or equal 45 years-old no known hearing problem Exclusion Criteria: professional musician history of neurologic, psychiatric or cadiologic disease treatment which could impact parameters of brain tissue pulsatility and peripheral nervous system opposition to use the data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amplitude of variations in brain tissue pulsatility | in micrometers | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | beat by minute | Baseline | 
| breathing rate | Frequency | Baseline | 
| skin conductance | in milliVolt | Baseline | 
| score of barcelona music reward questionnary (BMQR) | BMQR: Barcellona Music Reward Questionnaire for the evaluation of musical anhedonia; Only the total score of musical reward will be reported; for total score, minimum value is 20, maximum value is 100. Values under 40 represent low values in the overall score; values above 60 indicate high values in the overall score; High global score (>60) represents a better outcome; low global score (<40) represents a worse outcome, notably an impairment in music reward processing; The overall score is computed by adding raw scores of the items (except for items 2 and 5, which need to be reversed). | Baseline |
TRANSCRIBE (Transcriptomic Analysis of Left Ventricular Gene Expression)

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The investigators hypothesize that genetic variants will alter gene expression in response to ischemia during cardiopulmonary bypass. To test this, the investigators will be taking small pieces of heart tissue from patients undergoing heart surgery before and after this period of ischemia. This will be compared to blood gene expression in blood cells and analyzed with the patients' genetic profile. This might allow us to assess the amount of inflammation that occurs when patients are on the heart-lung machine as well as examine the effects genes have on this critical time period.

Official Title
-----------------
Whole Genome Expression of Left Ventricular Myocardium During Cardiac Surgery

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged greater than 20 years Undergoing aortic valve surgery with or without CABG surgery Receive and apical vent as part of the surgery Exclusion Criteria: Will not receive an apical left ventricular vent

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Differential gene expression |  | Immediate |
An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.

Conditions
-----------------
Spinocerebellar Degeneration

Intervention / Treatment
-----------------
* Drug: KPS-0373, High dose
* Drug: KPS-0373, Low dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese SCD patients with mild to moderate ataxia (Completion of the KPS1301 study) Exclusion Criteria: Less than 75% of compliance in KPS1301 study

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KPS-0373<br> | Drug: KPS-0373, High dose<br> <br> Drug: KPS-0373, Low dose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARA (Scale for the Assessment and Rating of Ataxia) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-8 (QOL) |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA), Cortical Cerebellar Atrophy (CCA)
Montessori-Based Activities for Elderly Persons With Dementia

Study Overview
=================
Brief Summary
-----------------
This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.

Detailed Description
-----------------
Studies have shown that Montessori-based activities, which focus on developing an individual's unique abilities, are effective in increasing engagement between nursing home residents with dementia and their caregivers. This study will determine whether the positive effects of Montessori-based programming can be replicated in adult day care, assisted living, and nursing homes. Results from this study will be used to create training materials to help staff in different settings implement the intervention within existing schedules, staffing, and programming routines. This study will be conducted in two phases. During Phase I, participants with mild dementia will be trained to become small group leaders for Montessori-based activities. In Phase II, newly-trained participants will use their skills to assist others. Assessments will be made throughout the study. Participants' engagement with the environment and caregiver burden and satisfaction will be assessed.

Official Title
-----------------
Programming for Dementia: Maximizing Abilities

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Behavioral: Montessori-based dementia programming


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of dementia Living in or attending programs at participating sites Exclusion Criteria: Medical conditions that would interfere with study participation

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Montessori-based dementia programming|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
-----------------
Aged, Nursing Homes, Assisted Living Facilities