linjc16/ctgov huggingface dataset:
Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The purpose of this study is to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.

Official Title
-----------------
Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: insulin glargine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | After 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety variables |  |  | 
| 8-point plasma glucose profile |  |  | 
| other glycemic variables |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes
IMRT/Pemetrexed/Cisplatin in Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of concomitant late course accelerated hyperfractionation radiochemotherapy with pemetrexed and cisplatin in patients with esophagus cancer

Official Title
-----------------
Phase I Study of Concurrent Selective Lymph Node Late Course Accelerated Hyper-fractionated Radiotherapy and Pemetrexed, Cisplatin for Locally Advanced Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent; 2.Acquired pathological diagnosis; 3.Life expectancy≥6 months; 4.Age:18-75 years, male or female; 5.General state of health: ECOG 0-1 grade; 6.Without any chemotherapy or radiotherapy; 7.Subjects meet the following criteria for the clinical laboratory:HG≥100g/L, WBC≥3.5X109 /L, neutrophilic leukocyte≥1.5X109,PLT100X109 /L。CR≤1.5 x N，TB≤2.5XN，AST and ALT≤2.5xN，AKP≤2.5XN. Exclusion Criteria: 1.Serious infection; 2.Uncontrollable diabetes; 3.Other serious diseases, such as myocardial infarction in 6 months; 4. Participated other clinical trials in 4 weeks or at present

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
IMRT,Pemetrexed,Cisplatin , Esophageal Cancer
ABC Program in Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Aims: We evaluate the efficacy of the Active Body Control (ABC) Program for weight reduction in patients with metabolic syndrome. Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized, clinical trial 60 patients will be treated according to the ABC program and 60 control patients will receive standard therapy.

Conditions
-----------------
Weight Reduction in Patients With Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome Exclusion Criteria: tumor cachexia

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 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 |
| --- | --- |
| case goup<br>Lifestyle counseling, ABC program | |
| control group<br>usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight reduction |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of metabolic syndrome |  | 12 month |
It is a Prospective Study Aiming to Identify Incidence and Prevalence of Cardiovascular Diseases, Changes in Physical Activity, Dietary Habits and Anxiety Depression Levels Through a Period of Time in the Naval Personnel (PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases)

Study Overview
=================
Brief Summary
-----------------
Prospective study. Starting from 2014 all newly appointed 1st year cadets in Naval Academies will be enrolled until the class of 2025. Physical examination, food frequency questionnaire, physical activity questionnaire, anxiety/depression questionnaire, medical history will be filled out at first interview. Specific blood tests will be performed. Every participant will be interviewed every three years and will complete the same questionnaires. Follow up period is determined ten years after last class enrollment

Official Title
-----------------
The PrOspeCtive HEllenic NAval PersoNnel StUdy in CardiovaScular Diseases (OCEANUS Study)

Conditions
-----------------
Cardiovascular Diseases, Risk Factor, Cardiovascular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Non signed consent form

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence / prevalence of CVD |  | 20 years |
Modified Atkins Diet and Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
This randomized control trial compared the influence of an Atkins diet to that of the ADA recommended diet on Type 2 diabetic obese patients during a one-year follow-up period

Official Title
-----------------
Influende of a Modified Atkins Diet on Glucose Metabolism and Weight Loss in Obese Type 2 Diabetic Patients - A Randomized Controlled Trial

Conditions
-----------------
Obese Type 2 Diabetic Patients

Intervention / Treatment
-----------------
* Other: modified Atkins diet
* Other: ADA recommended diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients age 35-75 years BMI 30-39.9kg/m HbA1C>7% Not receiving insulin Micro-albumin excretion<60 mg/day Exclusion Criteria: Serum creatinine level > 1.4 mg per deciliter Diastolic blood pressure > 100 mmHg or systolic blood pressure > 180mmHg Liver disease LDL cholesterol > 160 mg per deciliter despite lipid-lowering treatment Use of psychiatric medications Osteoporosis Cancer Food allergies, and Low carbohydrate diet in the past 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATK<br>modified Atkins diet | Other: modified Atkins diet<br>* subjects assigned to follow modified Atkins diet for 1 year<br>|
| Experimental: ADA<br>subjects assigned to follow ADA recommended diet for 1 year | Other: ADA recommended diet<br>* subjects assigned to follow ADA recommended diet for period of 1 year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss and glucose control |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile, kidney function |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, atkins, weight reduction, kidney function
Measuring Ability of Healthy Volunteers to Power a Bicycle-powered Oxygen Concentrator

Study Overview
=================
Brief Summary
-----------------
The investigators would like to test how well healthy human volunteers power a modified oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a bicycle instead of wall power so that it can be used in low resource countries where the power supply is unreliable.

Detailed Description
-----------------
The investigators would like to test how many healthy people can power the oxygen concentrator by pedaling the bike for at least 30 minutes. If the healthy volunteers can bike for at least 30 minutes, the investigators assume they are pedaling at or below their lactate threshold. The investigators have literature values which suggest bigger people should be able to output more work, and the investigators wish to use a sample of the population to verify that most of the people can power our system. The investigators have a good estimate of the power required by our system, and the investigators want to verify the average person can actually do what we calculated is necessary.

Official Title
-----------------
Measuring Ability of Healthy Volunteers to Power a Bicycle-powered Oxygen Concentrator

Conditions
-----------------
Physical Exertion

Intervention / Treatment
-----------------
* Other: Volunteer to pedal a bicycle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers will be included if they are between 18 and 45 years of age and if they do not have physical restrictions which would preclude them from riding a bike for 30 minutes. Exclusion Criteria: 1)anyone with known cardiovascular, pulmonary, or metabolic disease or 2)an age of greater than 45 or 3) one or more of the following symptoms: On medication for their heart Suffer from pains in their chest Ever feel faint of have spells of severe dizziness High blood pressure Currently on blood pressure medication Have a bone or joint problem such as arthritis that has been aggravated by exercise Unaccustomed to vigorous exercise Have experienced unusual heart beats such as skipped beats or palpitations Experience shortness or loss of breath while walking with others your own age Have been diagnosed with diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Volunteers<br>Healthy volunteers willing to pedal a bike for 30 minutes. | Other: Volunteer to pedal a bicycle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capable of pedaling the bike for 30 minutes |  | 30 minutes from the start time | 
| Average heart rate |  | Average for the 30 minute pedaling session | 
| volume of oxygen generated |  | 30 minutes |
LPHP-Philos-PHN Conservative Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the results regarding fracture healing and functional outcome after the treatment of proximal humeral fractures with the four different treatment methods after 12w./6months and 12 months based on radiological evaluation as well as the constant score and the neer score.

Detailed Description
-----------------
Evaluation of proximal humeral fractures using a new stable-angled implant.

Official Title
-----------------
Comparison of Standard Treatment Methods for Proximal Humerus Fractures

Conditions
-----------------
Proximal Humeral Fracture

Intervention / Treatment
-----------------
* Device: Locking proximal humerus plate
* Device: Proximal Humerus Internal Locking System
* Device: Proximal Humerus Nail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fractures of proximal humerus age over 18 years completed skeletal development fracture less than 5 days old Exclusion Criteria: open fractures pseudoarthrosis, pathological or refractures ipsilateral fractures of distal humerus or elbow polytraumatic conditions pregnancy subject with known history of diseases that influence the healing process alcohol, drug abuse

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Locking proximal humerus plate|nan|
|Device: Proximal Humerus Internal Locking System|nan|
|Device: Proximal Humerus Nail|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological comparison of the fracture healing |  |  | 
| Functional outcome based on constant and neer score after 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of occured complications |  |  | 
| Radiological evaluation of possible misallocation |  |  | 
| Subjective patient judgement of before and after treatment according to DASH-questionnaire |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nail System, Humerus, Fractures, Locking Plates
IMPACT Study (Improving Measurements of Persistence on ACtonel Treatment)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.

Official Title
-----------------
A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate.

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: risedronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory women, Caucasian, Oriental or Multiracial not previously diagnosed for osteoporosis. Exclusion Criteria: Females of black descent and for the US african american are excluded because of the very low incidence of postmenopausal osteoporosis and having used oral or parenteral glucocorticoids (>= 5 mg prednisone or equivalent per day) within 3 months of starting study drug or for more than one month within six months prior to study entry. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO. |  | collected at week 10 and 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to establish the profile of the unrecognized osteoporotic woman (PVD-, RF-) using a risk factor questionnaire for osteoporosis |  | During the study conduct | 
| to assess the decrease of type I collagen breakdown products(urinary NTX and serum CTX) |  | after 10 and 22 weeks of treatment | 
| To assess the change in BMD of both total hip and lumbar spine; |  | at week 52 compared to baseline | 
| osteoporosis-related genotyping. |  | During the study conduct |
Diclofenac Potassium With Lidocaine Cream in Reducing Pain During HSG

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG.

Official Title
-----------------
Randomized Clinical Trial of Oral Diclofenac Potassium With Cervical Lidocaine Cream in Reducing Pain During HSG

Conditions
-----------------
Pain Relief With HSG

Intervention / Treatment
-----------------
* Drug: diclofenac potassium + lidocaine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient came for HSG Exclusion Criteria: any patient has contraindication to HSG

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>oral diclofenac potassium plus lidocaine anesthetic cream placed into their cervix immediately before HSG | Drug: diclofenac potassium + lidocaine<br>* patients will have of oral diclofenac potassium 60 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before HSG<br>* Other names: combined therapy;|
| Placebo Comparator: Group B<br>oral placebo tablets plus placebo cream placed into their cervix immediately before HSG | Drug: placebo<br>* patients will have of oral placebo tablet 60 minutes before the procedure plus placebo cream placed into their cervix immediately before HSG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during hysterosalpigography by visual analog scale |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score after hysterosalpigography |  | 30 minutes | 
| side effects of medication |  | 30 minutes |
Chung-ju Metabolic Disease Cohort (CMC) Study

Study Overview
=================
Brief Summary
-----------------
This is an observational study on the prevalence and incidence of diabetes and osteoporosis in a rural area of Korea.

Detailed Description
-----------------
Diabetes, metabolic syndrome and dyslipidemia are common and rapidly increasing in Asia. Our group constructed a cohort in Chung-ju city, a rural area in Korea, to observe the prevalence of metabolic diseases and its risk factors since 2003. About 12,000 subjects participated in this cohort study till 2006. Now, we are planning to follow-up these subjects and provide health examinations from May, 2007 to Feb, 2011. The prevalence and incidence of metabolic diseases including diabetes, hypertension, metabolic syndrome, dislipidemia and osteoporosis will be observed.

Official Title
-----------------
Chung-ju Metabolic Disease Cohort (CMC) Study

Conditions
-----------------
Metabolic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 30 years of age living in Chung-ju city (who participated in 2003-2006 cohort study) Exclusion Criteria: age under 30 subjects with known diabetes

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Control<br>Chung-ju cohort populations aged over 30 year-old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of diabetes |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of metabolic syndrome, dyslipidemia and osteoporosis |  | 4 years | 
| Insulin sensitivity and resistance of Korean subjects |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, metabolic syndrome, dyslipidemia, osteoporosis