linjc16/ctgov huggingface dataset:
Observational Study on Patients With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
The study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis B.

Official Title
-----------------
A Retrospective-prospective Observational Study to Evaluate the Effect of Anti-viral Treatment on the Long-term Outcome in Patients With Chronic Hepatitis B (SEARCH-B Study)

Conditions
-----------------
Chronic Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged over 30 (inclusive) years of old Patients has a history of diagnosis of chronic hepatitis B (ie. HBsAg positive for more than 6 months) For patients with HBsAg positive, patients should be undergoing anti-viral treatment For patients with HBsAg negative, a documented evidence of previous anti-viral treatment should be provided. Life expectancy is more than 1 year Good treatment compliance. Exclusion Criteria: Patients has a history of diagnosis of hepatocellular carcinoma Patients with Child Pugh C Coinfected with HCV, HDV and HIV Suffering from other serious disease Taking part in other clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Cumulative rates of hepatocellular carcinoma |  | Year 5 |
Evaluation of EndoRefix Endovascular Delivery System and Staple

Study Overview
=================
Brief Summary
-----------------
This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.

Official Title
-----------------
Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures

Conditions
-----------------
AAA Graft Implant for Primary Aneurysm Treatment, AAA Graft Repair to Extend Life of Implant

Intervention / Treatment
-----------------
* Device: EndoRefix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female >21 years of age Undergoing endovascular stent grafting for AAA repair Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak. Exclusion Criteria: Pregnant Religious, cultural or other objection to the receipt of blood, or blood products. Unwilling to comply with follow-up schedule Unwillingness, or inability to provide informed consent to both trila and procedure Ruptured Aneurysm Area where staple is to be placed has significant loose thrombus associated with it Acute or chronic aortic dissection or mycotoc aneurysm Allergy to device materials Allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine. Clinically and morbidly obese such that imaging would be severely adversely affected. Uncorrectable bleeding abnormality Inflammatory aneurysm Connective tissue disease (e.g., Marfans syndrome, Ehlers Danlos syndrome) Patients with PTFE grafts Patients with investigational grafts (i.e., those grafts that are not FDA approved)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endorefix<br>Evaluation of EndoRefix Endovascular Delivery System and Staple | Device: EndoRefix<br> <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
-----------------
Abdominal Aortic Aneurysm
Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

Study Overview
=================
Brief Summary
-----------------
Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum

Detailed Description
-----------------
The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12 15cm from anus and low resection as 6 8cm.

Official Title
-----------------
High Resection vs. Low Resection of Rectum in Laparoscopic Total Colectomy for Slow Transit Constipation

Conditions
-----------------
Slow Transit, Constipation

Intervention / Treatment
-----------------
* Procedure: Laparoscopic total colectomy + low resection of rectum
* Procedure: Laparoscopic total colectomy + High resection of rectum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as constipation according to Rome IV criteria Diagnosed as slow transit constipation With more than 2 years' drug treatment or with outlet obstruction or with surgical history Exclusion Criteria: Colon cancer History of colon, rectum, anus surgery With severe cardio, renal, neural disease Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 15 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High resection<br>Laparoscopic total colectomy + High resection of rectum | Procedure: Laparoscopic total colectomy + High resection of rectum<br>* Laparoscopic total colectomy + High resection of rectum<br>|
| Experimental: Low resection<br>Laparoscopic total colectomy + Low resection of rectum | Procedure: Laparoscopic total colectomy + low resection of rectum<br>* Laparoscopic total colectomy + low resection of rectum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year recurrence rate of constipation | 1-year recurrence rate of constipation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year rate of diarrhea | 1-year rate of diarrhea | 1 year | 
| perioperative complications | perioperative complications | 1 year |
Diabetes-Specific Nutritional Formulas Versus Oatmeal

Study Overview
=================
Brief Summary
-----------------
Diabetes-specific nutritional formulas (DSNFs) are frequently used as part of medical nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and enhance weight reduction. The mechanism through which DSNFs improve postprandial (PP) plasma glucose is not yet known. The aim of this study is to compare the effects of 2 DSNFs versus oatmeal on PP plasma glucose, serum insulin and serum active glucagon-like peptide-1 (GLP-1), serum free fatty acids (FFA) and serum triglycerides (TG).

Official Title
-----------------
Effect of Diabetes-specific Formulas on Glucose Metabolism and GLP-1 Secretion in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Oatmeal breakfast
* Dietary Supplement: Glucerna formula
* Dietary Supplement: Ultra Glucose Control formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes treated with oral diabetes medications Exclusion Criteria: Type 1 diabetes

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?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oatmeal breakfast<br>consuming 200 kcal of plain cooked oatmeal for breakfast | Dietary Supplement: Oatmeal breakfast<br> <br> Dietary Supplement: Glucerna formula<br> <br> Dietary Supplement: Ultra Glucose Control formula<br> <br> |
| Active Comparator: Glucerna formula<br>consuming 200 kcal of Glucerna shake for breakfast | Dietary Supplement: Oatmeal breakfast<br> <br> Dietary Supplement: Glucerna formula<br> <br> Dietary Supplement: Ultra Glucose Control formula<br> <br> |
| Active Comparator: Ultra Glucose Control formula<br>consuming 200 kcal of Ultra Glucose Control shake for breakfast | Dietary Supplement: Oatmeal breakfast<br> <br> Dietary Supplement: Glucerna formula<br> <br> Dietary Supplement: Ultra Glucose Control formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose area under the curve 0-240 minutes |  | 240 minutes |
Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother

Study Overview
=================
Brief Summary
-----------------
This is a single-centre, open, parallel-group study with three age groups; no study medication or intervention will be provided. This is a longitudinal follow-up of physiological parameters.

Detailed Description
-----------------
The subjects will be investigated as outpatients. For each subject, 4 individual dates with a duration of approximately 30 minutes each are scheduled - at the end of the first trimenon, at the end of the second trimenon, 4 weeks prior to the calculated date of birth, and 6 weeks after the effective date of birth.

Official Title
-----------------
An Open Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother (Hormonal and Age Related Changes of the Aortal Elasticity)

Conditions
-----------------
Pregnancy Trimester, First, Pregnancy Trimester, Second, Pregnancy Trimester, Third

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women without major concomitant disease Willing and able to provide informed consent Age (three age groups): 20 to 22 years 30 to 32 years 40 to 42 years Exclusion Criteria: Non pregnant women Men No informed consent Age not included in inclusion criteria Major concomitant disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>20 to 22 years | |
| 2<br>30 to 32 years | |
| 3<br>40 to 42 years | |

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
-----------------
G08.520.769.550.408, G08.520.769.550.490, G08.520.769.550.520
Frequency of Metabolic Syndrome in Down Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the frequency of metabolic syndrome in Down syndrome patients because the prevalence of diabetes mellitus and obesity is higher in individuals with Down syndrome than in the general population.

Official Title
-----------------
Prevalence of Metabolic Syndrome in Down Syndrome Patients

Conditions
-----------------
Metabolic Syndrome X, Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Down syndrome Exclusion Criteria: History of congenital cardiac defects requiring open-heart surgery History of gastroenterologic anomalies requiring bowel resection and/or ongoing medical intervention History of leukemia or other cancer History of hypothyroidism requiring thyroid hormone replacement

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 24 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 |
| --- | --- |
| Case<br>Patients with clinical and cytogenetics diagnosis of Down syndrome, between 7 - 24 years old. | |
| Control<br>Siblings of the same gender of the case, between 7-24 years old. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the frequency of the metabolic syndrome among Down syndrome patients. Metabolic syndrome was defined by Adult Treatment Panel III criteria modified by Halley-Castillo. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the insulin resistance and insulin sensitivity using the HOMA and QUICKY methods. |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down syndrome, Metabolic syndrome X, Insulin resistance
Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the shape and dimension of dental arches from a lingual perspective, and determine shape and size used for lingual Orthodontics.

Detailed Description
-----------------
The study sample comprised 70 Caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys. Maxillary and mandibular dental casts were digitized (3D) and the images were analyzed by Delcam Power SHAPET 2010 software. Landmarks on the lingual surface of teeth were selected to determine the shape and size of dental arches.

Official Title
-----------------
Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.

Conditions
-----------------
Dental Arch Relationship Anomaly

Intervention / Treatment
-----------------
* Other: general group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:criterion was that individuals should be at least 15 years of age all permanent teeth in occlusion - Exclusion Criteria:with no odontogenic abnormalities -

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 21 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 |
| --- | --- |
| general group<br>Comprised 70 caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys. | Other: general group<br>* The sample comprised maxillary and mandibular dental casts of 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years, all of which had natural normal occlusion with at least four of the six keys to normal occlusion. 14 The first item of the first key was considered essential for sample selection(Angle Class I molar relationship). Another inclusion criterion was that individuals should be at least 15 years of age with no odontogenic abnormalities and all permanent teeth in occlusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistic study | describe arch form similar a mushroom arch | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthodontics, Dental arch, Orthodontic appliance design.
Internet Diabetes Self-Management Workshop

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine of the effectiveness of an Internet based Diabetes Self-Management workshop for people with type II diabetes. Half of the people who complete the workshop will be invited to continue their education by participating in a email discussion group. Thus, we will be able to learn both the efficacy of the original program as well as its efficacy when reinforced by the discussion group. Diabetes is a disease that must be managed day by day by the individual with the disease. Although we know a great deal about the self-management of type II diabetes, most self-management is less than optimal. In addition, most people with diabetes do not have an opportunity to participate in formal diabetes education. This study will determine if an Internet delivered educational workshop will help people with diabetes manage their disease. Thus we will be measuring changes in behaviors, changes in symptoms and changes in HbA1c, blood pressure, cholesterol, and weight. If successful the workshop will serve as a prototype for Internet diabetes education.

Official Title
-----------------
Internet Diabetes Self-Management Evaluation

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: Internet Diabetes Self-Management Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria::- Diabetes type 2 Have internet access and email address Live in the United States 18 years of age or older Exclusion Criteria:- Previous participation in similar online or community-based self-management program Active treatment for cancer Pregnant

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: on-line self management intervention<br> | Behavioral: Internet Diabetes Self-Management Program<br> <br> |
| No Intervention: usual care control group<br> | |
| Experimental: on-line self management intervention with email reinforcement<br> | Behavioral: Internet Diabetes Self-Management Program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Measure: Health-related quality of life |  | 6 and 12 months | 
| Outcome Measure: Health behaviors |  | 6 and 12 months | 
| Health care utilization |  | 6 and 12 months |
MK0782 + Low-Dose Aspirin 7-Day Erosion Endoscopy Study (0782-001)

Study Overview
=================
Brief Summary
-----------------
This study will determine how if MK0782 is safe and tolerable and to determine how often and the severity of stomach and small intestine ulcers develop following administration of MK0782 plus enteric coated aspirin, rofecoxib 25mg plus enteric coated aspirin, naproxen 500 mg puls enteric coated asprin vs placebo. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Stomach Ulcer, Duodenal Ulcer

Intervention / Treatment
-----------------
* Drug: MK0782


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or non pregnant female 18 years of age or older (age at consent) Able to abstain from alcohol, tobacco, spicy foods, limit coffee Able to avoid strenuous activity Able to read and fill out a study diary Exclusion Criteria: You have participated in an investigational drug study within 4 weeks of entering this study Your weight is not within a specific range for the study You have a history of GI problems like a gastric ulcer You have had gastric or intestinal surgery You have had abdominal or chest surgery You are currently abusing drugs or alcohol or have a history of abuse You have a history of psychiatric disorders You are a smoker or have smoked during the last year

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0782|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Long-term Effect of Lanthanum Carbonate on Bone

Study Overview
=================
Brief Summary
-----------------
Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.

Official Title
-----------------
A Long-term, Observational Study to Monitor Mortality, Bone-related Adverse Events and the Safety of Subjects Who Were Recruited Into Study SPD405-309

Conditions
-----------------
Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: Lanthanum carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient who had exposure to lanthanum carbonate in SPD405-309
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>Patients being treated for hyperphosphatemia with any marketed product | Drug: Lanthanum carbonate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Study-emergent Bone-related Adverse Events (AEs) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Study-emergent Deaths |  | 5 years |