linjc16/ctgov huggingface dataset:
Pilot Study to Evaluate the Knowledge and Understanding on Surgery for Patients With Hysterectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the level of knowledge of surgery for women who underwent hysterectomy

Conditions
-----------------
Gynecologic Cancer, Myoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who underwent hysterectomy at National Cancer Center, Korea Age > 20 years Exclusion Criteria: The patients who refuse to participate or give consent to the procedure

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

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

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 |
| --- | --- | --- |
| Knowledge of hysterectomy | The questionnaire of hysterectomy knowledge will be conducted by professional experts content validity review. | No more than 5 years after hysterectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision conflict with hysterectomy | Decision Conflict Scale(DCS) will be used for decision of conflict with hysterectomy. | No more than 5 years after hysterectomy |
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.

Detailed Description
-----------------
This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Official Title
-----------------
Regulatory Post Marketing Surveillance of Prezista 400mg Tablet

Conditions
-----------------
Acquired Immune Deficiency Syndrome

Intervention / Treatment
-----------------
* Drug: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are prescribed with darunavir for treatment of Acquired Immune Deficiency Syndrome (AIDS) Exclusion Criteria: Known hypersensitivity to Prezista Prezista coadministered with medicinal products that are highly dependent on CYP3A for clearance

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 |
| --- | --- |
| Darunavir<br>Patients having Acquired Immune Deficiency Syndrome (AIDS) will be taking darunavir as per recommended doses. | Drug: No intervention<br>* This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily.<br>* Other names: Prezista;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | Up to 30 days from end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with viral load |  | Screening, Week 12, Week 24 | 
| Number of patients with CD4 T-cell count |  | Screening, Week 12, Week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIDS, Acquired Immune Deficiency Syndrome, TMC114, Darunavir, Prezista
Fetal Neurobehavior in Poly-drug Dependent Women

Study Overview
=================
Brief Summary
-----------------
This project examines fetal neurobehavior and maternal physiology in poly-drug dependent women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior and vagal tone in the post-partum period.

Detailed Description
-----------------
Little is known about the link between maternal physiology, fetal neurobehavior and neonatal abstinence syndrome in multiply drug-dependent women. Previous research by this group of investigators has found that the severity of neonatal abstinence syndrome in methadone exposed infants is related to maternal vagal tone changes in response to methadone during pregnancy. While previous research has focused on drug abstinent, methadone maintained women, most drug dependent pregnant women are poly-substance abusers who also use prescription psychiatric medications, alcohol and nicotine. This protocol seeks to further our understanding of the effects of multiple drugs on the fetus, including the co-variate effects of maternal psychological status. Infant neurobehavior and vagal tone will also be evaluated. This research will extend our knowledge of fetal neurobehavioral development and neonatal abstinence syndrome in a realistic population of poly-drug dependent women, potentially altering the way in which these women are evaluated and their infants monitored and treated for neonatal abstinence syndrome.

Official Title
-----------------
Methadone, Buprenorphine and Fetal Neurobehavior

Conditions
-----------------
Poly Drug Exposed Pregnancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-41 Single intrauterine fetus Free of significant maternal or fetal significant health complications Exclusion Criteria: Development of significant maternal or fetal health complications Significant maternal psychopathology that would preclude informed consent Unwilling or unable to receive methadone at prescribed times

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 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 |
| --- | --- |
| Observational<br>Poly drug dependent women | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fetal heart rate |  | 120 minutes | 
| fetal movement |  | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal abstinence syndrome |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance abuse, fetal development, vagal tone
Efficacy and Safety of AMN107 in Patients With GastroIntestinal Stromal Tumors (GIST) Who Have Failed Both Imatinib and Sunitinib

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of nilotinib in gastrointestinal stromal tumors patients who failed imatinib and sunitinib therapy.

Official Title
-----------------
A Multi-center Phase II Study to Evaluate the Efficacy and Safety of AMN107 (Nilotinib) in Patients With Gastrointestinal Stromal Tumors Who Have Progressed on or Are Intolerant to Both Imatinib and Sunitinib

Conditions
-----------------
Gastrointestinal Stromal Tumors

Intervention / Treatment
-----------------
* Drug: AMN107


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented disease progression during imatinib and sunitinib therapy OR intolerance to imatinib and/or sunitinib At least one measurable site of disease on CT/MRI scan PS≤2 Normal organ, electrolyte, and bone marrow function Exclusion Criteria: Previous treatment with nilotinib or any other drug in this class or other targeted therapy Treatment with any cytotoxic and/or investigational drug ≤ 4 weeks prior to study entry Impaired cardiac function Use of coumarin derivatives (i.e. warfarin) Women who are pregnant or lactating Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nilotinib<br> | Drug: AMN107<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate (DCR) in all patients with either sunitinib-resistant GIST or in patients with GIST who are intolerant of sunitinib |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCR in patients with sunitinib-resistant GIST, Progression free survival (PFS), overall survival (OS), Objective response rate (ORR) |  | 24 weeks | 
| Safety |  | 24 weeks | 
| PK profile |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nilotinib, AMN107, Sunitinib, Sunitinib malate, Imatinib, Imatinib mesylate, Tyrosine
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery and Intraperitoneal Chemohyperthermia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the treatment of a cancerous disease of the peritoneum with complete cytoreductive surgery with intraperitoneal chemohyperthermia using oxaliplatin plus irinotecan. This is a Phase II study with 100 patients. Origins of the tumors: these include colon, rectum, appendix, peritoneum, and endocrine tumors.

Official Title
-----------------
Treatment of a Cancerous Disease of the Peritoneum With Complete Cytoreductive Surgery With Intraperitoneal Chemohyperthermia Using Oxaliplatin Plus Irinotecan

Conditions
-----------------
Colon Tumors, Rectum Tumors, Appendix Tumors, Peritoneum Tumors, Endocrine Tumors

Intervention / Treatment
-----------------
* Drug: Oxaliplatin and irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peritoneal seedings coming from colon, rectum, pseudomyxoma (appendix), peritoneum (mesothelioma and serous tumors), or endocrine tumors. No extra-abdominal metastases Good general status (American Society of Anesthesiologists Physical Status score [ASA] 1 or 2) Signed consent Exclusion Criteria: Tumor seedings coming from other origins Huge peritoneal carcinomatosis (peritoneal score > 25, except for pseudomyxomas) Peritoneal carcinomatosis progressing rapidly Presence of extra-abdominal metastases Patients presenting contraindications to the use of oxaliplatin or irinotecan

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin and irinotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study mortality-morbidity |  |  |
Health Outcomes of Teens Participating in Summer Employment Immersion Programs

Study Overview
=================
Brief Summary
-----------------
This study is a collaboration between investigators and two community partners: a youth employment program and an urban farm. The community partners hire 300+ adolescents for summer jobs at various organizations. Approximately 120 adolescents will be employed with the urban farm site. As one component of their program evaluation plan, investigators will evaluate change in BMI of participants. The investigators hypothesize that there will be a reduction in BMI of those participants working at the urban farm site.

Detailed Description
-----------------
The investigators will measure height/weight/BMI of all participants located at the urban farm site. Investigators will also collect demographic data as well as other social data (example: food security).

Official Title
-----------------
Health Outcomes of Teens Participating in Summer Employment Immersion Programs

Conditions
-----------------
Pediatric Obesity, Prediabetic State

Intervention / Treatment
-----------------
* Behavioral: Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: employed by summer work program at urban farm Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This study has a single arm. All participants in a summer employment program at an urban farm in Indianapolis, IN are invited to participate. | Behavioral: Measurement<br>* The intervention consists of diabetes prevention education sessions focusing on increasing physical activity and decreasing the intake of sugared drinks while increasing intake of fruits and vegetables. The 2-hr sessions occur weekly for 6 weeks. Height and weight is measured for each consenting participant at baseline and after 6 weeks. Participants are also asked to complete a short questionnaire to collect demographic and knowledge data. Outcome measures include: BMI, knowledge of physical activity and dietary habits conducive to diabetes prevention, and feelings of food insecurity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | 6 weeks |
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.

Study Overview
=================
Brief Summary
-----------------
This study will use Continuous Glucose Monitoring to assess differences in glycemic profiles between vildagliptin and glimepiride.

Official Title
-----------------
Pilot Study to Assess the Difference in Glycemic Profiles Between Vildagliptin and Glimepiride Using Continuous Glucose Monitoring Device

Conditions
-----------------
Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Vildagliptin
* Drug: Glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes patients on stable metformin 18-70 years old Willing to perform at least 4 capillary blood glucose tests per day Exclusion Criteria: Type 2 diabetes patients on any other antidiabetic treatment Patients listed in other trials Patients with significant diabetic organ disease or complications. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: Vildagliptin<br> <br> |
| Active Comparator: Glimepiride<br> | Drug: Glimepiride<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycemic profiles between vildagliptin and glimepiride |  | Baseline and treatment Day 5, 24hr continuous glucose measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Fluctuation before and during treatment |  | Baseline and treatment Day 5, 24hr continuous measurements | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type II Diabetes Mellitus, Vildagliptin, Glimepiride, Continuous glucose monitoring
Cytokine Levels in Conversion Disorder

Study Overview
=================
Brief Summary
-----------------
The aim of this study is whether the proinflammatory cytokine levels in patients with conversion disorder is increased or not changed in the acute phase and subacute - chronic periode, compared with controls.

Official Title
-----------------
Proinflammatory Cytokine Levels in Patients With Conversion Disorder

Conditions
-----------------
Conversion Disorder

Intervention / Treatment
-----------------
* Other: conversion disorder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Alzheimer's Disease Exclusion Criteria: Autoimmune disease Neurological disease Any organic disorder that could possibly affect proinflammatory cytokines Pregnancy Any drug usage within 2 weeks Any active or passive immunization within 6 months Any other DSM-IV axis I psychiatric disorder Mental retardation Developmental disorder of childhood

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Conversion disorder<br> | Other: conversion disorder<br>* Proinflammatory cytokine levels in conversion disorder<br>|
| Healthy control<br> | Other: conversion disorder<br>* Proinflammatory cytokine levels in conversion disorder<br>|

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
-----------------
conversion, cytokine, inflammation
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the efficacy and safety of 2 concentrations of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.

Official Title
-----------------
A Multicenter, Double-Masked, Parallel-Group, Vehicle-Controlled Study to Assess the Efficacy and Safety of RX-10045 Nanomicellar Ophthalmic Solution for Treatment of Ocular Inflammation and Pain in Subjects Undergoing Cataract Surgery

Conditions
-----------------
Inflammation, Pain, Cataract

Intervention / Treatment
-----------------
* Drug: RX-10045


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag. Exclusion Criteria: Any additional surgical procedures at the time of the cataract surgery Refractive surgery in the study eye within the past 2 years History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye Intraocular pressure of > 21 mm Hg in either eye Proliferative or severe nonproliferative diabetic retinopathy in either eye Neovascular/wet age-related macular degeneration in either eye

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RX-10045 0.05% nanomicellar solution<br>topical eye drops | Drug: RX-10045<br>* topical therapy<br>|
| Experimental: RX-10045 0.1% nanomicellar solution<br>topical eye drops | Drug: RX-10045<br>* topical therapy<br>|
| Placebo Comparator: Vehicle<br>topical eye drops | Drug: RX-10045<br>* topical therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Clearing of Anterior Inflammation | score of zero for the Standardization of Uveitis Nomenclature scale | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Reporting no Ocular Pain |  | Day 3 |
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

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

Intervention / Treatment
-----------------
* Other: Lubricant Eye Drop
* Other: Refresh Liquigel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye NaFl Corneal staining sum score ≥ 3 in either eye Current use of a lubricant eye gel or ointment at least once per week (over the previous month) Exclusion Criteria: No contact lenses wear throughout the study period Must not have had punctal plugs inserted within 30 days preceding enrollment

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 115958D<br>Lubricant Eye Drop | Other: Lubricant Eye Drop<br>* 1 drop in each eye, four times a day for 42 days<br>|
| Active Comparator: Refresh Liquigel<br>Lubricant Eye Drop | Other: Refresh Liquigel<br>* 1 drop in each eye, four times a day for 42 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Staining |  | Day 42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, artificial tears, corneal staining