linjc16/ctgov huggingface dataset:
Evaluating Effectiveness of Spices and Herbs to Increase Vegetable Intake Among Military

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate whether the addition of spices and herbs to the vegetables served to active-duty Service Members living on a large military base can increase vegetable intake as compared to typical vegetable offerings without spices and herbs. The two-phase study design that was successfully implemented by the University of Maryland School of Medicine research team in the most recent Baltimore high school spices and herbs vegetable intervention will be largely replicated, with key adaptations made to reflect the military base setting and specific needs of the active-duty military population that will be determined in a stakeholder engagement process.

Official Title
-----------------
Evaluating Effectiveness of Spices and Herbs to Increase Vegetable Intake Among Military

Conditions
-----------------
Dietary Intake

Intervention / Treatment
-----------------
* Other: Spiced
* Other: Plain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Junior Enlisted (E1-E4) Service Member assigned to Naval Support Activity Bethesda (NSAB) Live in barracks on NSAB Read and write English Exclusion Criteria: Anyone under 18 years of age Anyone not Active Duty in the U.S. military

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

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vegetables<br>Vegetables will be provided to volunteers as part of a heat and serve meal kit. | Other: Spiced<br>* Vegetables provided to volunteers will be spiced.<br>Other: Plain<br>* Vegetables provided to volunteers will be plain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vegetable consumption | Volunteers will provided with a heat and serve meal kit. Using the food photography mobile application (SmartIntake), volunteers will take a single photo of the meal kit after they have consumed a self-determined desired amount of food. The digital photo will be sent to Pennington Biomedical Research Center (PBRC) for analysis via the SmartIntake app. The team at PBRC will download the image and use a validated algorithm to estimate, in cups, the remaining vegetable component from the meal kit. | Volunteers will be provided with a series of heat and serve meal kits over approximately 2 month time period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Military, Vegetable intake, Food photography
Implantable Antenna Sensors for Continuous Glucose Monitoring

Study Overview
=================
Brief Summary
-----------------
The researchers' long-term goal is to develop a small implantable device that can continually monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect the antenna signals and those can be used to predict the patient's glucose levels.

Detailed Description
-----------------
Our goal is to develop a small size implantable device that can continually monitor glucose levels. The scientific objective of this application is to examine the efficacy of using implantable antennas to measure the glucose levels. The central hypothesis of this application is that the changes in the glucose levels in the medium surrounding the antenna will affect the antenna parameters such as input impedance and resonance frequency, and these changes can be used to predict the patient's glucose levels. We have formulated this hypothesis on the basis of our preliminary data, which will be detailed later, in the Preliminary Studies section. The rationale for the proposed research is that, once the correlation between the glucose levels and antenna parameters are determined, the design of a miniaturized long term glucose monitoring device will become a reality.

Official Title
-----------------
Implantable Antenna Sensors for Continuous Glucose Monitoring

Conditions
-----------------
Type 1 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult able to give a blood sample Exclusion Criteria: Adults with diabetes or other glycemic or hematologic disorders. Sick adults

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
antenna, continuous glucose monitoring, electromagnetic
Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia

Study Overview
=================
Brief Summary
-----------------
This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions. The goal of this study is to provide answers to the following four questions: What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)? Are the side effects with sublingual use tolerable for women? Is sublingual administration of misoprostol acceptable to women? Are women satisfied with counseling and services received in new centers offering medical abortion?

Official Title
-----------------
An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP

Conditions
-----------------
Induced Abortion

Intervention / Treatment
-----------------
* Drug: Mifepristone, misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women presenting for medical abortion who consent to participate Possibility of final gestational age of less than or equal to 63 days General good health Willing to provide contact information for purposes of follow-up Exclusion Criteria: Conditions which contraindicate the use of mifepristone or misoprostol Women presenting for medical abortion who do not consent to participate
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mifepristone, misoprostol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. |  | 2 weeks after mifepristone administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 48 hours | 
| Acceptability for women |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical abortion, mifepristone, misoprostol, Tunisia
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)

Study Overview
=================
Brief Summary
-----------------
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.

Official Title
-----------------
A 28-week Extension to a 24-week Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency

Conditions
-----------------
Diabetes Mellitus, Type 2, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete the core study and consent for extension Exclusion Criteria: Patient unable to comply with core study requirements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: 1<br>50mg qd vildagliptin | Drug: vildagliptin<br>* 50mg qd<br>|
| Active Comparator: 2<br>sitagliptin (25mg qd) | Drug: sitagliptin<br>* 25mg qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment emergent adverse events (including hypoglycemia events and other events of special interest) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reduction from baseline after 52 weeks of treatment |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Horton & Maizy Pilot Study for Resistant to Starch

Study Overview
=================
Brief Summary
-----------------
This is a pilot study and will be used to power an NIH grant application on the effect of resistant starch on weight gain in children.

Detailed Description
-----------------
Stool fatty acids and stool pH from the baseline and week 4 stool samples will be compared by paired-t test. The stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla.

Official Title
-----------------
The Effect of Resistant Starch on the Stool Microflora of Children: A Pilot Study

Conditions
-----------------
pH, Weight Gain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female between the ages of 5 and 15 years Exclusion Criteria: Gastrointestinal disease Medication such as antibiotics that have the potential for altering the gut bacterial flora. Allergic to milk or corn products.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 15 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 |
| --- | --- |
| Healthly children<br>Children will be given yogurt twice a day for four weeks. The dose for an adult is 8 ounces of yogurt twice a day. The dose will be scaled to the children based upon surface area dosing charts, but will not exceed a resistant starch load of 1 gram per year of age plus 10 grams10. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of resistant starch on weight gain in children | During the 4 weeks while still consuming the yogurt supplements, 3 daily stool samples will be collected in the same manner as the baseline stool collections. Stool fatty acids from the baseline and week 4 stool samples will be compared by paired-t test. The stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla. | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of resistant starch on weight gain in children | During the 4 weeks while still consuming the yogurt supplements, 3 daily stool samples will be collected in the same manner as the baseline stool collections. Stool pH from the baseline and week 4 stool samples will be compared by paired-t test. The stool microflora changes will be reported using descriptive statistics for the percent changes in the different bacterial phyla. | Four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stool fatty acid
Development of Web Application and Evaluation Its Impact on Healthy Lifestyle

Study Overview
=================
Brief Summary
-----------------
The study is planned for people who would like to reduce or maintain their weight and keep a healthy life style .After signing an informed consent, participants will be divided randomly into two groups :control group and an intervention group that will get the application (eBalance ). Participants will be followed for 12 weeks.

Detailed Description
-----------------
Primary objective: to develop a web application based on energy balance and evaluates its effectiveness in promoting healthy lifestyle habits versus a control group. Secondary objectives: To evaluate the frequency and convenient of usage of the internet intervention To test the impact of the intervention on nutrition knowledge, diet quality and physical activity To evaluate the effect of the intervention on weight management status

Official Title
-----------------
Development of Internet Web Application and Evaluation of Its Impact as a Tool in Promoting Healthy Lifestyle Indicators in Adults

Conditions
-----------------
Lifestyle

Intervention / Treatment
-----------------
* Other: ebalance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People aged more than 18 years Web and e-mail experience Interested in either reducing weight or maintaining a healthy lifestyle Exclusion Criteria: without any mail experience pregnancy involvement in other diet programs

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard care<br>standard care ,without the web application ebalance | Other: ebalance<br>* using the ebalance application for 14 weeks<br>|
| Active Comparator: ebalance<br>using the ebalance application for 14 weeks | Other: ebalance<br>* using the ebalance application for 14 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | measuring weight at baseline and end of 14 weeks | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of physical activity | at baseline and end of study | 14 weeks | 
| Nutrition knowledge | questionnaire at baseline and end of study | 14 weeks | 
| waist circumference | waist circumference will be measured at baseline and end of 14 weeks | 14 weeks | 
| height | height will be measured at baseline | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
web application, nutrition knowledge, physical activity
Early Detection of Arteriosclerosis

Study Overview
=================
Brief Summary
-----------------
Arteriosclerosis is a common chronic disease with well known risk factors like diabetes mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications like myocardial infarction, stroke or peripheral arterial occlusive disease. In addition to life-style factors there is also a genetic predisposition to develop complicated atherosclerosis. Objective: Improve individual risk prediction by clinical phenotyping and genotyping.

Detailed Description
-----------------
About 300 patients who are treated for various conditions at the department of general medicine at our hospital will be included prospectively in the study. This observational cohort will be followed for at least 10 years follow-up examinations. At baseline and during follow up visits detailed clinical phenotyping is planned (medical and family history,standardized clinical and physical examinations, lab, RX, ECG, stress-test or echocardiogram). The genotyping is performed by DNA-isolation from leucocytes collected at baseline.

Official Title
-----------------
Prospective Observational Cohort Study for Early Detection of Arteriosclerosis

Conditions
-----------------
Arteriosclerosis, Atherosclerosis, Myocardial Infarction, Stroke, Diabetes Mellitus, Peripheral Arterial Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older informed consent Exclusion Criteria: life-threatening disease life expectancy < 1 month uncapable to provide informed consent

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 |
| --- | --- |
| 1<br>no cardiovascular events | |
| 2<br>proven cardiovascular events | |
| 3<br>possible cardiovascular events | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events |  | 10 years at least | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease activity score |  | 2 / 5 / 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical examination, diagnostic techniques and procedures, diagnosis, immunologic tests, diagnostic tests, causality, genetic test, biomarker
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to see if giving the drug SCH66336 by mouth can improve the disease in patients with chronic or accelerated phase CML. The safety of this treatment will also be studied.

Detailed Description
-----------------
Objectives for this study are two-fold: To determine the efficacy of SCH66336 in patients with chronic phase and accelerated phase CML in relation to response rate, duration of response, and survival. To assess the toxicity of SCH66366 in these patients.

Official Title
-----------------
Phase II Study of SCH66336, A Farnesyltransferase Inhibitor in Chronic Myelogenous Leukemia (CML)

Conditions
-----------------
Myelogenous Leukemia, Chronic

Intervention / Treatment
-----------------
* Drug: SCH66336


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of Philadelphia chromosome (Ph) -positive CML in chronic or accelerated phase; Failure to respond to or intolerance to imatinib mesylate (Gleevec); Age >/= 16 years; Life expectancy of >/= 2 months; Performance status 2 or better (Zubrod); Adequate renal and hepatic functions (creatinine and bilirubin </= 2 mg/dl); Adequate cardiac function; Not candidates for or have refused allogeneic transplantation; Patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, HIV protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SCH66336|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
-----------------
Philadelphia chromosome positive CML, Myelogenous Leukemia, Chronic, Chronic Phase, Myelogenous Leukemia, Chronic, Accelerated Phase