linjc16/ctgov huggingface dataset:
Zinc and Biobehavioral Development in Early Childhood

Study Overview
=================
Brief Summary
-----------------
Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.

Official Title
-----------------
Zinc and Biobehavioral Development in Early Childhood

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Dietary Supplement: zinc
* Dietary Supplement: iron + copper


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born at term of non-low birth weight Free of major malformations, genetic abnormalities or health problems associated with developmental delays Planning to remain in study area for one year In good general health Exclusion Criteria: Low birth weight Non-term delivery Vision or hearing problems Anemia

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>iron + copper + zinc | Dietary Supplement: zinc<br>* 10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age<br>|
| Active Comparator: 2<br>iron + copper only | Dietary Supplement: iron + copper<br>* 10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive development(visual attention, executive processing, vigilance) |  | 6, 9, 12, and 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zinc, iron, child development, visual attention, Peru
NT-proBNP as a Tool for the Detection of Acute Pulmonary Artery Embolism (APE)

Study Overview
=================
Brief Summary
-----------------
In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were measured according to the standard hospital protocol. To definitively confirm or exclude APE, all patients underwent an angiographic CT-scan of the thorax.

Detailed Description
-----------------
In patients with suspected APE referred to the intensive care unit after major surgery, serum NT-proBNP, Troponin-I and D-dimers were measured according to the standard hospital protocol. Blood samples were obtained within one hour after the onset of clinical symptoms. Definitive confirmation or exclusion of APE was performed with an angiographic CT-scan of the thorax.

Official Title
-----------------
NT-proBNP: a Useful Tool for the Detection of Acute Pulmonary Artery Embolism in Post-surgical Patients

Conditions
-----------------
Pulmonary Embolism, Pulmonary Embolism Without Mention of Acute Cor Pulmonale

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients referred to the ICU with suspected APE 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 |
| --- | --- |
| Suspected APE<br>Post-surgical patients with clinically suspected acute pulmonary embolism | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute pulmonary embolism: CT-proof yes vs. no |  | 1 hour after onset of clinical symptoms | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Misadventures to Patients During Surgical and Medical Care, Pulmonary Embolism Without Acute Cor Pulmonale, Pulmonary Embolism Without Mention of Acute Cor Pulmonale
Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with Attention- Deficit/Hyperactivity Disorder

Official Title
-----------------
A Phase IIIb Open-Label Trial of Atomoxetine Hydrochloride to Evaluate Academic Outcome in Children Ages 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: atomoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients must have ADHD, be psychotropic medication naive and be outpatients who are at least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached their 11 birthday) so that all year testing will be completed before the child reaches age 12. Exclusion Criteria: -Patients with current or past history of Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder or serious suicidal risk are excluded

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 11 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: atomoxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to assess the correlation of change from baseline to one year in ADHD symptoms as measured by the Attention Deficit/Hyperactivity Disorder Rating Scale- IV- |  |  | 
| Parent Version: Investigator Administered and Scored, |  |  | 
| total score, with change from baseline in academic achievement of medication-naive patients treated with atomoxetine at one year as measured by the total |  |  | 
| of the composite scores of the broad reading, broad math, and broad language subtests of the Woodcock-Johnson Tests of Achievement (WJII) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the correlation of change from baseline to one year or at study discontinuation in ADHD symptoms as measured by the ADHDRS-IV-Parent:Inv with change from baseline with each of the academic achievement composite scores of the broad reading, broa |  |  |
Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study)

Study Overview
=================
Brief Summary
-----------------
The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications.

Official Title
-----------------
A Cross-sectional, Retrospective Screening and Case-control Study Examining the Frequency of, and Risk Factors Associated With, Impulse Control Disorders in Parkinson's Disease Patients Treated With MIRAPEX® (Pramipexole) and Other Anti-parkinson Agents (DOMINION Study)

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Observation Criteria: Male or female outpatients, aged 30 to 75 years of age, with idiopathic PD. Patients must be selected on the basis of a prospective recruitment plan documented at the site, with the objective of obtaining an unbiased representative sample. Patients must have been treated with anti-parkinson medication for a period of one year or greater and demonstrated a treatment response, in the opinion of the Investigator. Patients must be willing and able to comply with study procedures. Patients must be willing and able to give meaningful, written informed consent. This must be completed prior to beginning any study procedures, in accordance with GCP and local legislation. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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 |
| --- | --- |
| Parkinson's patients<br>Observational study to compare rates of impulse control disorders in patients taking different medications for Parkinson's Disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of current ImpulseControl Disorder(ICD) assessed via + res. of Modif.Massachusetts Gambling Screen,Modif.Minnesota Impulsive Disorder Interview for Sexuality,Modif.MIDI for Compulsive Buying,DSM-IV binge-eating research criteria questionnaire |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of a past (since onset of PD) ICD |  | 6 months | 
| Demographic and medical history measures |  | up to 14 days after Visit 1 | 
| Scores on psychiatric/neuropsychological instruments/tests |  | up to 14 days after Visit 1 |
Use of Closed-loop Anesthesia in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia

Official Title
-----------------
Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: remifentanil
* Drug: Propofol
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: class ASA I, II or III general anesthesia scheduled to last more than one hour intraoperative hemorrhage planned to be less than 15% of the blood volume Exclusion Criteria: Combined general and regional anesthesia, Patients with a pacemaker or scheduled for a cardiac or brain surgical procedure, History of a neurological or a psychiatric disorder, or central brain lesion, Patients receiving a psychotropic treatment or a a morphine agonist-antagonist, Allergy to latex, propofol, remifentanil, morphine, muscle relaxant, or to a component, Hypersensibility to remifentanil or to a derivate of fentanyl, Scheduled postoperative ventilation or sedation.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 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 |
| --- | --- |
| Experimental: 1<br>closed-loop administration of propofol and remifentanil using bispectral index as the controller | Drug: Propofol<br>* closed-loop administration using bispectral index as the controller<br>Drug: remifentanil<br>* closed-loop administration using bispectral index as the controller<br>|
| Active Comparator: 2<br>manual administration of propofol and remifentanil according to bispectral index values | Drug: Propofol<br>* manual administration according bispectral index values<br>Drug: Remifentanil<br>* manual administration according bispectral index values<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time during which the bispectral index is between 40 and 60 |  | anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| propofol and remifentanil doses |  | anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia
Diet and Stool Metabolites in Fecal Incontinence

Study Overview
=================
Brief Summary
-----------------
Fecal Incontinence (FI) is a debilitating and common condition with a prevalence ranging from 7-15% in community dwelling women. FI has an immense impact on quality of life and is associated with increased care giver burden, increased rates of institutionalization, and significant cost burden in older women. Traditionally believed to be primarily caused by child birth injury, recent studies show that the typical age of onset of FI is age 40 which is remote from child birth. Treatment options for FI are limited because the mechanism underlying FI in older women are poorly understood. The overriding goal of this project is to investigate the relationship between diet, stool metabolites and fecal incontinence.

Official Title
-----------------
Diet and Stool Metabolites in Women With Fecal Incontinence

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18, parous women with fecal incontinence (defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment), current negative colon cancer screening Exclusion Criteria: Current bloody diarrhea, current or past diagnosis of colorectal or anal malignancy, diagnosis of inflammatory bowel disease, recent antibiotic treatment, history of immune deficiency diseases, history of recent treatment with immune suppressant medications.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fecal incontinence<br>Women age >18 years old with a diagnosis of fecal incontinence | Other: No Intervention<br>* No intervention<br>|
| Controls<br>Women age >18 without a diangosis of fecal incontinence | Other: No Intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool butyrate levels |  | within 1 week of collection | 
| Pattern of dietary intake by indicator |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool levels of global metabolites |  | within 1 week of collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fecal incontinence, diet, nutrition, metabolites, stool, FI
Evaluation of Visual Acuity and Patient Satisfaction With AT LISA TRI 839MP Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the far, intermediate and near visual acuities with a trifocal IOL.

Detailed Description
-----------------
After bilateral cataract surgery, monocular and binocular uncorrected (UCVA) and best distance corrected visual acuity (BCVA) will be measured at far (4m), intermediate (80 cm) and near (40 cm) distance as well as the subjective refraction. A patient questionnaire will be used to assess the patient satisfaction and spectacle independence.

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: AT LISA tri 839MP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman, over 50 years of age Bilateral implantation of a trifocal intraocular lens Capsular bag implantation Exclusion Criteria: Existing ocular pathology Surgical complications Corneal astigmatism ≥ 1.0D

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Other: implantation of a trifocal IOL (AT LISA tri 839MP)<br> | Device: AT LISA tri 839MP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermediate visual acuity | Monocular and binocular uncorrected and best distance corrected | up to 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| near and far visual acuity | Monocular and binocular uncorrected and best distance corrected | 1 and 3 month postoperatively |
Effect of U-Health Service in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Provides mobile programs for occupational and speech therapy to patients with stroke.

Official Title
-----------------
U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Mobile program for occupational and speech therapy
* Other: Traditional rehabilitation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke confirmed by brain imaging study Impairment in upper extremity function or speech native speaker of Korean Exclusion Criteria: previous history of aphasia psychiatric or psychotic problem severe cognitive dysfunction severe hearing or visual loss cannot sit with devices
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 |
| --- | --- |
| Active Comparator: Traditional therapy<br>Traditional rehabilitation therapy | Other: Traditional rehabilitation therapy<br> <br> |
| Experimental: Mobile program<br>Mobile program for occupational and speech therapy | Other: Mobile program for occupational and speech therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer upper extremity scale | upper extremity function test | 4weeks | 
| short form K-FAST (Korean version of Frenchay Aphasia Screening) | speech function screening test | 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength | hand power measurement | 4weeks | 
| K-WAB(Korean version-the Western Aphasia Battery) | speech evaluation | 4weeks |
Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which drug makes lower migraine headache

Detailed Description
-----------------
There are different options to manage benign headache in emergency department.The investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve pain in emergency department.

Official Title
-----------------
Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: metoclopramide, injection,20mg, one time
* Drug: Sumatriptan, injection, 6 mg, one time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-60 years old and presented with acute headache similar to previous episodes, with or without phonophobia, photophobia, vomiting or nausea. Exclusion Criteria: fever or neck stiffness, altered mental state, pregnancy, recent trauma or seizure (within 24 hours), focal neurological abnormality on physical examination, allergy to metoclopramide, hypertension, cardiovascular diseases. Also if the patients had taken a triptan or ergot during the last 24 hours were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: sumatriptan<br>Patients who underwent 6 mg sumatriptan subcutaneous one time | Drug: Sumatriptan, injection, 6 mg, one time<br>* Sumatriptan, subcutaneous injection, 6 mg, one time<br>|
| Other: Metoclopramide<br>Patients who underwent 20 mg Metoclopramide intravenous one time | Drug: metoclopramide, injection,20mg, one time<br>* metoclopramide, intravenous injection,20mg, one time<br>* Other names: plasil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | determining pain in Metoclopramide versus sumatriptan groups | at one hour after prescription | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metoclopramide, Sumatriptan, migraine, headache