linjc16/ctgov huggingface dataset:
A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes

Study Overview
=================
Brief Summary
-----------------
This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.

Official Title
-----------------
A Single-blind, Single-treatment Study to Evaluate the Effects of Vildagliptin on Response to an Intravenous Glucose Load in Pre-diabetic Subjects With Impaired Fasting Glucose

Conditions
-----------------
Pre-diabetes

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI in the range 22-45 and with a stable weight for the last 6 months Blood glucose criteria must be met Written informed consent Exclusion Criteria: Pregnancy or lactation Previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents Type 1 diabetes Evidence of cardiovascular complications as defined by the protocol Evidence of diabetic complications as defined by the protocol

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in acute insulin response to an iv glucose load at 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glucose disappearance rate at 6 weeks |  |  | 
| Change from baseline in glucose disappearance rate at 8 weeks |  |  | 
| Change from baseline in insulin sensitivity at 6 weeks |  |  | 
| Change from baseline in insulin sensitivity at 8 weeks |  |  | 
| Change from baseline in acute insulin response to an iv glucose load at 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vildaglptin, Pre-diabetes
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate

Study Overview
=================
Brief Summary
-----------------
This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.

Official Title
-----------------
Comparison of Basal (Fasting) Glycemic Control in Type 1 Diabetic Patients With CSII Achieved by the Circadian Slide Ruler Scale or Flat Basal Rate

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

Intervention / Treatment
-----------------
* Device: Accu-Chek Spirit Insulin Pump
* Device: Accu-Chek Spirit Insulin Pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients >= 18 years of age Type 1 diabetes Diabetic for >2 years, and treated with CSII for >= 3 months HbA1c <=8.5% Exclusion Criteria: Excessive fibrosis or lipo-hypertrophy at injection or infusion sites Unstable chronic disease other than type 1 diabetes Severe hypoglycemic event within last week prior to study start Severe diabetic ketoacidosis within last month prior to study start

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Accu-Chek Spirit Insulin Pump<br>* One basal rate<br>|
| Experimental: B<br> | Device: Accu-Chek Spirit Insulin Pump<br>* Multiple basal rates<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot trial to establish endpoints such as time within target range of a composite fasting day |  | Study duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, MAGE, HbA1c, body weight change |  | Study duration |
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.

Official Title
-----------------
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: CLP
* Drug: Spironolactone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure with New York Heart Association (NYHA) Classification II or III Chronic kidney disease Cardiac ejection fraction <40% On heart failure therapy including an ACEI or ARB, and a BB Willing to understand and comply with study procedures and provide written informed consent. Exclusion Criteria: Hospitalization within 4 weeks of baseline visit History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures Current or anticipated dialysis during study In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe Drug or alcohol 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLP with spironolactone<br> | Drug: CLP<br>* Oral administration<br>Drug: Spironolactone<br>* oral administration<br>|
| Experimental: CLP without spironolactone<br> | Drug: CLP<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fecal Sodium Content | Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average) | baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fecal Weight | Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average) | baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32) |
WINCATI Software Tool for Survey Research

Study Overview
=================
Brief Summary
-----------------
To design Computer Aided Telephone Interviewing (CATI) software tools for survey research.

Detailed Description
-----------------
BACKGROUND: CATI (Computer Aided Telephone Interviewing) became a primary means of obtaining quality epidemiological data. Its use steadily increased and in 1995 it was a major technology in use by almost every NIH Institute. Although CATI had been used for many years, its implementation had not kept up with technological developments in computers. Available CATI software products were deficient in features, inflexible, difficult to learn to use and had copious problems. Modern computer technology had the potential to satisfy the growing need for an improved product. This product had applications in over 3000 U.S. companies engaged in public opinion and market research. DESIGN NARRATIVE: In Phase I the investigators identified approaches that could be used to develop this software; justified and chose an approach; created requirements and designed specifications for the tool; developed a prototype; and produced a detailed project plan for implementation. In Phase II, the investigators completed and improved the prototype software and tested it in several areas

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
A Pharmaceopidemiological Study in Patients Who Use Symbicort SMART

Study Overview
=================
Brief Summary
-----------------
To investigate how common it is that patients using Symibort SMART take high average daily doses that are not considered appropriate by their physician (overuse) or are hospitalised due to their asthma at least partly due to underuse.

Official Title
-----------------
A Pharmaceopidemiological Study in Patients Who Use Symbicort Turbuhaler as Maintenance and Reliever Therapy (Symbicort SMART) Capturing Over Use and Under Use Via the General Practice Research Database

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma diagnosis, patient registered with the prescribing physician for at least one year before the qualifying prescription of Symbicort, prescription of Symbicort SMART after UK launch of the concept Exclusion Criteria: None
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
-----------------
pharmaceopidemiological, Symbicort SMART, GPRD
The Utility of Cell-free DNA Methylation Markers for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The subjects of this study were patients with liver cancer diagnosed by physicians according to AASLD clinical criteria or pathological biopsy. Those who plan to receive systemic drug treatment for liver cancer in National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yervoy. Weak and uncooperative patients were excluded from blood tests, which were performed with full informed consent for relevant tumor markers (AFP ,PIVKA-II and methylation analysis). The data are then counted and compared.

Official Title
-----------------
The Utility of Cell-free DNA Methylation Markers for the Response Prediction of Systemic Treatment for Hepatocellular Carcinoma

Conditions
-----------------
Cell-free Methylation Markers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with liver cancer by AASLD clinical criteria or pathological slides Patients planning to receive systemic drug therapy for liver cancer at National Taiwan University Hospital include Nexavar, Lenvatinib, Avastin, Tecentriq, Strivarga, Cabometyx, Cyramza, Nivolunab, Pembrolizumab, and Yevoy. Over 20 years old. In the case of informed consent, willing to sign the consent form of the subjects. Exclusion Criteria: Patients who are weak and unable to cooperate with blood test. Kidney dysfunction, serum creatinine greater than 1.5 x UNL (normal value) and no hemodialysis treatment, who are judged to be unwell for computed tomography or MRI contrast agent injection.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Evaluate efficacy | Correlation of methylation profiling results and tumor treatment response. | 3 month after treatment |
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip articulating surfaces in cementless total hip arthroplasty.

Detailed Description
-----------------
This evaluation is being conducted to investigate the extent of metal ion release and its incorporation into the surrounding tissue resulting from metal on metal articulating surfaces in cementless total hip arthroplasty. The amount of metallic ions released post operatively will be assessed by the concentration of Cobalt, Chromium and Molybdenum present in urine and analysed by I.C.P.M.S. (Inductive Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to the hip function and range of motion measured pre-operatively and post-operatively. Secondary performance of the metal-on-metal articulation will be determined by radiographic evaluation and incidence of complications / revision rates.

Official Title
-----------------
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Avascular Necrosis, Traumatic Arthritis, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Procedure: Metal on Metal cementless hip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects selected for this Evaluation will be grouped by initial diagnosis into one of the following diagnostic groups: Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis. Rheumatoid arthritis. Selection of subjects for this Evaluation should include the following considerations: Patients under 70 years of age. Willing to return for follow-up evaluations. No bias to sex. Exclusion Criteria:

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metal on Metal cementless hip<br>Metal on Metal cementless hip arthroplasty | Procedure: Metal on Metal cementless hip<br>* Metal on Metal hip arthroplasty<br>* Other names: metal on metal hip arthroplasty;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of Cobalt, Chromium and Molybdenum ions in urine |  | various follow-up visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| harris Hip Score, oxford hip, WOMAC and SF-12 |  | various follow-up visits |
The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy

Study Overview
=================
Brief Summary
-----------------
CTC levels collected pre-surgery will be correlated with pathological samples.

Detailed Description
-----------------
Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore & describe the pattern of CTC detection in all patients

Official Title
-----------------
The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen. Age 18 or older Signed informed consent Patients who are incapable of providing informed consent are excluded from participating in this study.

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 |
| --- | --- |
| Cohort 1<br>Patients with early stage NSCLC undergoing stereotactic radiotherapy | Radiation: Radiotherapy<br> <br> |
| Cohort 2<br>Patients with locally advanced NSCLC undergoing standard chemoradiotherapy | Radiation: Radiotherapy<br> <br> |
| Cohort 3<br>Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone | Radiation: Radiotherapy<br> <br> |
| Cohort 4<br>Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir. | Radiation: Radiotherapy<br> <br> |
| Cohort 5<br>Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy | Radiation: Radiotherapy<br> <br> |
| Cohort 6<br>(Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy) | Radiation: Radiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating tumor cells will be detected by imaging for green fluorescent protein (GFP) which measures cells which high levels of telomerase activity after adenovirus transduction. CTCs are measured in units of number of GFP-positive cells /mL. |  | 24 months |
Evaluation of Revascularization of Failed Endodontically Treated Mature Permanent Teeth

Study Overview
=================
Brief Summary
-----------------
Retraetment of failed previous endodontic treated mature permenant teeth with revascularization versus retreatment by conventional endodontic treatment

Official Title
-----------------
Evaluation of Revascularization of Failed Endodontically Treated Mature Permanent Teeth

Conditions
-----------------
Revascularization

Intervention / Treatment
-----------------
* Other: Revascualrization
* Other: Conventional endodontic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pescence of failed endodontic treated mature permenant tooth Healthy patients Age of 10 years to 18 years Exclusion criteria: Medically compromised patients Mentally compromised patients

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revasularization<br> | Other: Revascualrization<br>* Regain pulp vascularity for mature permenant teeth<br>|
| Active Comparator: Conventional endodontic treatment<br> | Other: Conventional endodontic treatment<br>* Root canal treatment of permenant mature teeth with mechanical preparation and cleaning followed by canal obturation by inert material ( gutta percha)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Number of participants with pain, mobility and/or fistulous tract (+/-) | 1 year | 
| Radiographic success | Absence of periapical radiolucency | 1 year |