linjc16/ctgov huggingface dataset:
The Influence of Radiotherapy on Cognitive Function

Study Overview
=================
Brief Summary
-----------------
The cognitive function of 150 patients that undergone any Radiotherapy treatment to the brain will be assessed at 3 time points before and after the treatment.

Detailed Description
-----------------
The basic cognitive function and QOL of 150 oncologic patients that undergone Radiotherapy or Radiosurgery treatment to the brain due to primary tumor, metastases or increased risk of brain metastases, will be assessed at 3 time points: before the treatment, immediately after the treatment, and on the next follow up visit. The assessment tools that will be used are Neurotrax standard cognitive computerized tests and 2 short questionnaires.Patients that will receive a one-day treatment will be tested on 2 time points only- before the treatment and on FU.The research will reveal the positive and the negative influences of the Radiotherapy, along with the assessment of norms for the cognitive function and quality of life of oncologic patients being treated by RT.Eligibility criteria:oncologic patients of both genders, with primary brain tumors, metastases or with increased risk of brain metastases, that are referred to conformal/palliative or preventive Radiotherapy treatment or to Stereotactic Radiosurgery, who are able to follow instructions in Hebrew.The participants will be 20-80 years old.Main comparisons will be performed between the cognitive tests results on 3 time points mentioned. The study will continue until the needed number of participants will be achieved.

Official Title
-----------------
The Influence of the Radiotherapy or Stereotactic Radiosurgery on the Cognitive Function of the Patients With the Neurotrax Assessment System and a Cognitive Questionnaire.

Conditions
-----------------
Radiotherapy, Brain Neoplasms, Quality of Life

Intervention / Treatment
-----------------
* Procedure: Brain Radiotherapy/Stereotactic Radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-80 years old oncologic patients, of both genders, that are referred to Brain Radiotherapy or Stereotactic Radiosurgery due to primary brain tumor/ brain metastases or increased risk for brain metastases. Are able to follow instructions in Hebrew. Exclusion Criteria: Non-Hebrew speakers can not participate.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Brain Radiotherapy/Stereotactic Radiosurgery|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
-----------------
Psychology
Nursing-Home Residents Given Bread Fortified With Vitamin D3

Study Overview
=================
Brief Summary
-----------------
Background. For older adults, serum 25-hydroxyvitamin D (25(OH)D) higher than 75 nmol/L lowers fracture risk and attainment of this 25(OH)D target may require 125 mcg (5000 IU)/d of vitamin D3. Objective: We wanted to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D3.

Detailed Description
-----------------
Methods: In a single-arm design, 45 nursing-home residents consumed one bun/d that had been fortified with 125 mcg (5,000 IU) of vitamin D3 and 320 mg elemental calcium.

Official Title
-----------------
Long-Term Effects of Giving Nursing-Home Residents Bread Fortified With 125 Micrograms (5000 IU) Vitamin D3 Per Daily Serving

Conditions
-----------------
Vitamin D Deficiency, Low Bone Density

Intervention / Treatment
-----------------
* Dietary Supplement: Bread fortified with vitamin D3 and calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy seniors in an institution in Romania Exclusion Criteria: Known hypercalcemic or hypercalciuric disease

Ages Eligible for Study
-----------------
Minimum Age: 58 Years
Maximum Age: 89 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: Bread fortified with vitamin D3 and calcium<br> | Dietary Supplement: Bread fortified with vitamin D3 and calcium<br>* Bread fortified with vitamin D3 (5000 IU per bun) and calcium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25-hydroxyvitamin D response |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on serum calcium |  | 12 months | 
| Effects on urine calcium |  | 12 months | 
| Change in spine and hip bone mineral density, baseline vs final |  | 12 months | 
| Change in parathyroid hormone, baseline vs final |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dietary fortification, Vitamin D3, Osteomalacia, bread, bone mineral density, geriatrics, cholecalciferol, calcidiol, osteoporosis, dual-energy photon absorptiometry, bread fortification
Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

Study Overview
=================
Brief Summary
-----------------
This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. The gDNA will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.

Official Title
-----------------
Validation of DNA Methylation Biomarkers for Oral Cancer Detection-Follow up Study

Conditions
-----------------
Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with age over 20. Subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous lesion, and oral cancer) or subjects who have involved in the previous study (NCT01945697). Subjects agrees to sign the informed consent form. Exclusion Criteria: Pregnant woman. Subject disagrees to sign the informed consent form.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normal oral mucosa<br> | |
| oral precancerous lesion or oral cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA methylation |  | 2 years |
Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to ascertain factors shaping medical students' pre-residency intention to provide abortion through an in-depth qualitative investigation into the context and experiences that shape intention to provide.

Official Title
-----------------
Beliefs and Practice Intentions of Future Ob/Gyn Residents Regarding Reproductive Healthcare

Conditions
-----------------
Focus: Pre-residency Intention to Provide Abortion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current 4th-year medical student US accredited medical school has applied to, but not yet been accepted into, obstetrics and gynecology residency programs Exclusion Criteria: age less than 18 years former student reapplying to residency (e.g., not current 4th-year student) has not yet applied to residency has already been accepted to residency

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical Students<br>Fourth-year students in accredited US medical schools who have applied to, but not yet been matched with, residency programs in obstetrics and gynecology. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors affecting pre-residency intention to provide abortion | Factors will be identified by systematically coding qualitative data using a combination of deductive and inductive analytical strategies. | Up to 15 months. Each participant will be interviewed once, between January and March 2013 or between September 2013 through March 2014. |
Regulatory Nebilet PMS

Study Overview
=================
Brief Summary
-----------------
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information

Detailed Description
-----------------
An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information Nebivolol will be administered to Hypertension or Chronic heart failure (CHF) patients as described the prescribing information of Nebivolol by physician's decision.

Official Title
-----------------
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Nebilet Administered in Korean Patients According to the Prescribing Information

Conditions
-----------------
Hypertension, Heart Failure

Intervention / Treatment
-----------------
* Drug: Nebivolol


Participation Criteria
=================
Eligibility Criteria
-----------------
All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation: Subjects with indication in the prescribing information Subjects administrated Nebivolol by physician's decision Subjects with no contraindication according to the prescribing information
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients administrated Nebivolol<br>There is only one group. This group includes patients administrated Nebivolol | Drug: Nebivolol<br>* patients administrated Nebivolol according to the prescribing information<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events after Nebivolol administration |  | 3months, 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Occurrence of unexpected or serious adverse event after Nebivolol administration and effectiveness of Nebivolol |  | 3 months, 6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, PMS (post-marketing surveillance)
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis

Study Overview
=================
Brief Summary
-----------------
To compare once daily versus 8 hour dosing of gentamicin for the treatment of chorioamnionitis.

Official Title
-----------------
Comparison of Once Daily Versus 8 Hour Dosing of Gentamicin for the Treatment of Intrapartum Chorioamnionitis

Conditions
-----------------
Chorioamnionitis

Intervention / Treatment
-----------------
* Drug: gentamicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - clinical diagnosis of chorioamnionitis Exclusion Criteria: - maternal renal disease, intrauterine fetal death, allergy to gentamicin

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Once daily Gentamicin<br> | Drug: gentamicin<br>* Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours). Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours).<br>|
| Active Comparator: Every eight hour Gentamicin<br> | Drug: gentamicin<br>* Daily gentamicin (5 mg/kg intravenously, then placebo doses IV after 8 and 16 hours). Eight hour gentamicin (2 mg/kg intravenously, then 1.5 mg/kg IV after 8 and 16 hours).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Afebrile at 24 hours and no endometritis |  | 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal outcomes |  | Time of delivery to time of discharge |
Tolerance of Healthy Term Infants Fed Infant Formulas

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Official Title
-----------------
Tolerance of Healthy Term Infants Fed Infant Formulas

Conditions
-----------------
Infant, Newborn

Intervention / Treatment
-----------------
* Other: milk protein formulas, varying carbohydrate/protein sources


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age Exclusion Criteria: medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth

Ages Eligible for Study
-----------------
Maximum Age: 8 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Experimental milk protein based infant formula with varying carbohydrate and protein source | Other: milk protein formulas, varying carbohydrate/protein sources<br>* ad lib for 0-8 days of age until 28 days of age<br>|
| Experimental: 2<br>Experimental milk protein based infant formula with varying carbohydrate and protein source | Other: milk protein formulas, varying carbohydrate/protein sources<br>* ad lib for 0-8 days of age until 28 days of age<br>|
| Experimental: 3<br>Experimental milk protein based infant formula with varying carbohydrate and protein source | Other: milk protein formulas, varying carbohydrate/protein sources<br>* ad lib for 0-8 days of age until 28 days of age<br>|
| Experimental: 4<br>Experimental milk protein based infant formula with varying carbohydrate and protein source | Other: milk protein formulas, varying carbohydrate/protein sources<br>* ad lib for 0-8 days of age until 28 days of age<br>|
| Experimental: 5<br>Experimental milk protein based infant formula with varying carbohydrate and protein source | Other: milk protein formulas, varying carbohydrate/protein sources<br>* ad lib for 0-8 days of age until 28 days of age<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance |  | 0-8 days of age until 28 days of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI and intake parameters |  | 0-8 to 28 days of age |
Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).

Official Title
-----------------
Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: 1. Optive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 and over Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit. Complaint of dry eyes OSDI score > 23 Exclusion Criteria: Use of RGP or PMMA contact lenses Poorly fitting contact lenses Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study Concurrent use of topical medications other than study medications Use of systemic medications with ocular drying sequelae: Antihistamines Decongestants Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1.<br> | Drug: 1. Optive<br>* Optive 15ml- (in the eye) Instill one drop twice daily in each eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 8 months |
Assessment of Orality Disorders in Children With Food Allergies

Study Overview
=================
Brief Summary
-----------------
Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders. The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.

Official Title
-----------------
Assessment of Orality Disorders in Children With Food Allergies

Conditions
-----------------
Food Allergy in Children, 6 Years Old Maximum

Intervention / Treatment
-----------------
* Other: completion of questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every child aged between 6 month and 6 years, with one or several food allergy and under the care of allergy unity of University Hospital of Angers obtention of informed consent Exclusion Criteria: Child with allergy other than food poor understanding of french

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one arm<br>oral disorder | Other: completion of questionnaire<br>* parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of orality disorder in children with food allergy |  | Enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Link between orality disorder and number of excluded food, time from excluded regimen, age of the beginning of diet diversification, breastfeeding and duration,status of the child in the family and demographic data. | All data will be collected by a questionnaire established by Angers Hospital | Enrollment | 
| Link between food allergies and orality disorder | data will be collected by a questionnaire | Enrollment | 
| Prevalence of dysphagia criteria |  | Enrollment |