linjc16/ctgov huggingface dataset:
Iron Supplementation of Lead-exposed Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and placebo given for 6 months in preventing the elevation of blood lead concentration in children 6-9 months of age.

Official Title
-----------------
Pilot Study to Determine the Efficacy of Iron Supplementation in Preventing the Elevation of Blood Lead Concentrations in Young Children

Conditions
-----------------
Lead Toxicity

Intervention / Treatment
-----------------
* Drug: Ferrous sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants included if gestational age >36 weeks, birth weight > 2500g, no chronic illness, blood lead concentration <10 mcg/dL, hemoglobin >9 g/dL, zinc protoporphyrin >90 mmol/mol heme Mothers included if 18 years or older Exclusion criteria: Hemoglobin >11.5 g/dL

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ferrous sulfate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of blood lead concentrations > 10 mcg/dL |  |  | 
| Mean hemoglobin concentration |  |  | 
| Mean zinc protoporphyrin concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometry |  |  | 
| Oxidative stress |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lead toxicity
In Home Hospital Care Program

Study Overview
=================
Brief Summary
-----------------
To assess the hypothesis that In Home Hospital Care (IHHC) is as safe and effective, less burdensome to families, and less expensive for care of common acute pediatric problems now managed with hospitalization.

Detailed Description
-----------------
A randomized trial compared health care systems with and without IHHC. Eligible children presented to the Emergency Department of our medical center, had common acute problems, and were considered for hospital admission. Physicians decided disposition from the emergency department. Note that subjects were not randomized directly to IHHC but to a system of care that either included IHHC or did not. To allow best use of scarce home nursing resources, we used a disproportionate selection favoring the system with IHHC. Quality measures included adverse events, parent anxiety and satisfaction with care, family disruption, and perceived child health.

Official Title
-----------------
In Home Hospital Care Program

Conditions
-----------------
Common Acute Problems

Intervention / Treatment
-----------------
* Procedure: pediatric nursing used in home to avoid hospitalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomized from acute care clients presenting in Emergency Department to IHHC Exclusion Criteria: Randomized from acute care clients presenting in Emergency Department to inpatient hospital care.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- |
|Procedure: pediatric nursing used in home to avoid hospitalization|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IHHC delivers a more valuable service at lower cost. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute home care
Safety and Efficacy of a Drug Delivery System in Glaucoma

Study Overview
=================
Brief Summary
-----------------
Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: High Dose Drug Device
* Drug: Low Dose Drug Device
* Drug: Placebo Device
* Drug: bimatoprost 0.03%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman 21 years of age or greater Open angle glaucoma or ocular hypertension Corrected visual acuity in each eye of 20/200 or better Exclusion Criteria: Previous glaucoma intraocular surgery or refractive surgery Planned contact lens use during the study Clinically significant ocular or systemic disease that might interfere with the study Use of chronic corticosteroids by any route

Ages Eligible for Study
-----------------
Minimum Age: 21 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: High Dose Drug Device/ bimatoprost 0.03%<br>drug device containing 65 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). | Drug: High Dose Drug Device<br>* device inserted for 4 days<br>Drug: bimatoprost 0.03%<br>* one drop in each eye on one day only<br>|
| Experimental: Low Dose Drug Device / bimatoprost 0.03%<br>drug device containing 45 micrograms of bimatoprost released over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). | Drug: Low Dose Drug Device<br>* device inserted for 4 days<br>Drug: bimatoprost 0.03%<br>* one drop in each eye on one day only<br>|
| Other: Placebo Device / bimatoprost 0.03%<br>placebo drug device worn over 4 days (first period) bimatoprost 0.03% ophthalmic solution for one day (second period). | Drug: Placebo Device<br>* device inserted for 4 days<br>Drug: bimatoprost 0.03%<br>* one drop in each eye on one day only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Intraocular Pressure at Day 1 |  | Baseline to Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Intraocular Pressure at Day 2 |  | Baseline to Day 2 | 
| Mean Change in Intraocular Pressure at Day 3 |  | Baseline to Day 3 | 
| Mean Change in Intraocular Pressure at Day 4 |  | Baseline to Day 4 | 
| Mean Change in Intraocular Pressure at Day 5 |  | Day 4 to Day 5 |
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 weeks.

Official Title
-----------------
A Phase 2b, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of AR882 Versus Placebo in Gout Patients

Conditions
-----------------
Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic

Intervention / Treatment
-----------------
* Drug: AR882 Dose 1
* Drug: AR882 Dose 2
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of gout sUA > 7 mg/dL Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m2 Exclusion Criteria: Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin History of cardiac abnormalities History of kidney stones

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Group 1<br>AR882 Dose 1 x 12 weeks | Drug: AR882 Dose 1<br>* Solid Oral Capsule<br>|
| Experimental: Group 2<br>AR882 Dose 1 x 2 weeks, then Dose 2 x 10 weeks | Drug: AR882 Dose 1<br>* Solid Oral Capsule<br>Drug: AR882 Dose 2<br>* Solid Oral Capsule<br>|
| Placebo Comparator: Group 3<br>AR882 matching placebo x 12 weeks | Drug: Placebo<br>* Matching Solid Oral Capsule Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing | Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level < 6 mg/dL following 6 weeks of dosing | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sUA levels < 5, < 4, and < 3 mg/dL | Comparison of the treatment groups for proportion of patients whose sUA levels are < 5, < 4, and < 3 mg/dL | 6 weeks | 
| Incidence of Adverse Events | Treatment Emergent Adverse Events and Serious Adverse Event incidence. | 14 weeks | 
| Maximum Observed Plasma Concentration (Cmax) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Cmax. | 12 weeks | 
| Time to observed Cmax (Tmax) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive Tmax. | 12 weeks | 
| Area under the plasma concentration-time curve (AUC) | Plasma samples will be collected to assess plasma concentrations at a series of timepoints to derive AUC. | 12 weeks |
Canthaxanthin Retinopathy: A Long-term Observation

Study Overview
=================
Brief Summary
-----------------
Canthaxanthine is a naturally occurring carotenoid that has been a popular over-the-counter oral artificial tanning agent in Europe, Canada, and Australia since 1979. It is also used at low dosage as a food-colouring agent and as a therapeutic agent for photosensitivity disorders such as erythropoietic protoporphyria. Canthaxanthin retinopathy was first described in 1982 by Cortin et al. In Germany the office of the federal board of health refused the permit for oral tanning agents containing canthaxanthine in 1985. At that time the long-term course of the disease was not known. 25 years later the investigators did these long-term follow-up examinations.

Conditions
-----------------
Canthaxanthin Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients using oral tanning agents for at least 2 months. patients of 18 years or older Exclusion Criteria: none.

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 |
| --- | --- | --- |
| all eye diseases | All patients will have the follow-up examination 2008 or 2009. The examination included at most visual acuity (distant and near vision), Amsler test, examination of anterior segment, posterior segment, 10-2 and 30-2 visual field, electrooculography, electroretinography, multifocal electroretinography, fundus photography, fluorescein angiography, and an examination for autofluorescence. | 2008 and 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Canthaxanthin retinopathy
The Significance of Vitamin D Storage in Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

Detailed Description
-----------------
vitamin d versus placebo will be given for 12 months. Biopsies will be taken at baseline and every 6 month for 2 years. Blood samples will be collected every 6th month. the study will thus give information on storage during vitamin d supplementation as well as use of vitamin d fat stores after stopping vitamin D supplementation

Official Title
-----------------
The Significance of Vitamin D Storage in Adipose Tissue

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: cholecalciferol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: hypercalcemia pregnancy women without safe contraception

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cholecalciferol<br>vitamin d (cholecalciferol) will be given as a capsule of 20.000 Iu twice a week | Drug: cholecalciferol<br>* as in arm description<br>* Other names: Dekristol;|
| Placebo Comparator: placebo<br>the placebo capsules are looking identical to the vitamin d capsules and contain medium chain triglycerides and arachis oil | Drug: placebo<br>* capsule looking identical to the cholecalciferol capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D in adipose tissue biopsies |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of decline of 25ohd in serum |  | 12 months |
Calprotectin I Serum as a Diagnostic Marker

Study Overview
=================
Brief Summary
-----------------
Lower respiratory tract infection is the most common cause of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Patients diagnosed with pneumonia in addition to an AECOPD experience more severe clinical and laboratory disease manifestations, increase in-hospital morbidity and worse outcome. Clinicians have sought for new biomarkers that together with clinical assessments can improve the diagnostic accuracy of pneumonia in patients with AECOPD.The aim of the present study is to compare the accuracy of calprotectin with procalcitonin (PCT), C-reactive protein (CRP) and white blood cell count (WBC).

Official Title
-----------------
Calprotectin I in Serum as a Diagnostic Marker of Pneumonia in Patients Hospitalised With Acute COPD Exacerbation

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically confirmed acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) COPD diagnosis previously confirmed by spirometry according to the GOLD criteria. Exclusion Criteria: known malignant disease bronchiectasis chronic bacterial colonisation of the airways treatment with an immunosuppressive drug or long-term treatment with antibiotics. not examined with a chest X-ray at admission

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 |
| --- | --- |
| np-AECOPD<br>Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) and pulmonary infiltrate on chest X -ray at admission | |
| p-AECOPD<br>Patients with evidence of acute exacerbation of chronic obstructive pulmonary disorder (AECOPD) without pulmonary infiltrate on chest X -ray at admission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calprotectin concentration in serum | ELISA-kit (MRP8/14 ELISA) | Change in serum concentration from baseline to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Sensitivity and Specificity, Clinical Deterioration
Study on Visual Performance of a Monofocal Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL). The objective is to compare best corrected distance visual acuity (CDVA) between 1-3-month and 12- month follow-up.

Official Title
-----------------
Multicentric Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL)

Conditions
-----------------
Cataract Senile

Intervention / Treatment
-----------------
* Device: Monofocal IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older; Patients with monolateral or bilateral (only one eye will be the study eye) monofocal IOL implantation after uncomplicated surgery in the period between May 2019 and November 2019, if the follow-up visit can be performed 10-18 months after surgery; No visual acuity limiting pathologies; Availability of 1-3-month postoperative data Availability, willingness and sufficient cognitive awareness to comply with examination procedures in case of a prospective 12-month visit; Written informed consent for participation in the study and data protection. Exclusion Criteria: Difficulty for cooperation (distance from their home, general health conditions) Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that would confound visual acuity measurements; Subjects with surgical complications or secondary interventions (except for Nd:YAG capsulotomy) related to the cataract surgery of the monofocal IOL eye(s) or any other interventions in the post-operative eye including but not limited to glaucoma surgery, retinal surgery; Visual field loss which has impact on visual acuity; Use of systemic or ocular medication that might affect vision; Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus; Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome); Concurrent participation in another device investigation.

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 |
| --- | --- |
| Monofocal IOL<br>Patients already implanted with a monofocal IOL | Device: Monofocal IOL<br>* Patients are already implanted with a monofocal lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected distance visual acuity (CDVA) | Comparison between 1-3-month and 12- month follow-up results. | 12 months |
Antibodies to Digoxin for Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
Subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy. Patients also will be followed using clinical and psychological tests

Detailed Description
-----------------
Twenty subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will included in the study. All will receive in an open study only one intravenously dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy. Patients also will be followed using clinical and psychological tests

Official Title
-----------------
Antibodies to Digoxin for Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Digibind (Fab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted patients suffering from Bipolar Disorder abillity to give informed concent Exclusion Criteria: Allergy to Digoxin Antibodies Renal and Liver function impairment Liver Cirrhosis Asthma Patients on Digoxin or Digitoxin Patients receiving Aldactone therapy Heart A-V Block Hypo or Hyperkalemia on admission Potential Suicidal Behaviour

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: digibind<br>Injection of digibind and psychological tests | Drug: Digibind (Fab)<br>* Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Digoxin Antibodies, Bipolar Disorder