linjc16/ctgov huggingface dataset:
Buspirone Plus Omeprazole for Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
This study is a double-blinded Randomised clinical trial aim to compare buspirone plus omeprazole with placebo plus omeprazole.

Official Title
-----------------
Buspirone Plus Omeprazole for Functional Dyspepsia: A Randomised Placebo Clinical Trial

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Buspirone
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being over 18-year-old, Rome III criteria for FD normal upper endoscopy within five years negative Urease test for H-pylori acceptance informed concept form. Exclusion Criteria: denied to get these medications taking other drugs for FD patients with the organic gastrointestinal disorder

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buspirone plus Omeprazole<br> | Drug: Buspirone<br>* Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.<br>* Other names: Omeprazole;|
| Placebo Comparator: Placebo plus Omeprazole<br> | Drug: Placebo Oral Tablet<br>* Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.<br>* Other names: omeprazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 70 patients With functional dyspepsia symptoms, Change From Baseline by asking about symptoms at 4 Weeks after using buspirone or placebo | Global symptom measured through a checklist of dyspepsia symptoms at first visit and four weeks after | 4 weeks taking buspirone plus omeprasole or taking placebo plus omeprasloe | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional Dyspepsia
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Official Title
-----------------
A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Clinical Trial of Sitagliptin 100 mg and Sitagliptin 200 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet and Exercise

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate
* Drug: sitagliptin phosphate
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has Type 2 Diabetes Patient is between the ages of 30-65 years Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%). Exclusion Criteria: Patient has Type 1 Diabetes Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months Patient has taken insulin within the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sitagliptin 100 mg | Drug: sitagliptin phosphate<br>* sitagliptin 100 mg tablets q.d. (once daily) for 7 days.<br>* Other names: MK0431;|
| Experimental: 2<br>sitagliptin 200 mg | Drug: sitagliptin phosphate<br>* sitagliptin 200 mg tablets q.d. (once daily) for 7 days.<br>* Other names: MK0431;|
| Placebo Comparator: 3<br>Placebo | Drug: Comparator: Placebo<br>* sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Weighted Mean Glucose (WMG) | The 24-hour WMG was calculated as the area under the 24-hour glucose curve (AUC(0-24 hr)) divided by 24 using linear trapezoidal method. | Day 7 of Treatment Period I. Due to a carry-over effect that was observed between treatment periods, efficacy results are presented from Treatment Period I only. |
Automated Fastener Device Versus Manually Tied Knot in MiAVR

Study Overview
=================
Brief Summary
-----------------
The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT). Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158. The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.

Official Title
-----------------
Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Device: Cor Knot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years Elective patient Isolated aortic valve replacement with stented prosthesis Minimally-invasive approach (right anterior minithoracotomy) Exclusion Criteria: Associated procedure Aortic valve replacement with sutureless or rapid valve deployment prosthesis Active endocarditis Prior cardiac surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Sutures with hand-tied knots<br>Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots | |
| Sutures with automated fastener device (Cor-Knot)<br>Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot) | Device: Cor Knot<br>* Heart valve replacement with or without the use of automated fastener device Cor Knot<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac surgery times | Aortic cross-clamping and cardiopulmonary bypass times | peroperative data | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbimortality | Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation | Perioperative (30 days) and 24 months follow up |
Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes

Study Overview
=================
Brief Summary
-----------------
the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area.

Official Title
-----------------
Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes

Conditions
-----------------
Environmental Exposure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication Exclusion Criteria: smokers during 10 last years

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| high incidence crohn's disease area<br>subjects living in high incidence crohn's disease area coming in dentist for dental extraction linked to medical indication | |
| low incidence crohn's disease area<br>subjects living in low incidence crohn's disease area coming in dentist for dental extractionlinked to medical indication | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of aluminum rate using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas. |  | Baseline: one session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of environmental exposomes using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas. |  | Baseline: one session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental exposome
Orofacial Evaluation in Women With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis (RA) can affect any synovial joint. Unlike the hand, ever so valued in the physical examination of patients with RA, the joints in the area of the jaw and neck may also be affected in this disease and have their involvement usually underdiagnosed. There are few studies evaluating the incidence of orofacial alteration in the examination as well as the correlation between bite force (BF) and clinical and functional parameters in these patients. The aim of our study was to chacacterize the orofacial alterations in RA patients, correlate the results of the orofacial evaluation with clinical and disease activity parameters, and correlate the bite force with the hand strenght.

Official Title
-----------------
Orofacial Evaluation in Women With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RA group: rheumatoid arthritis (American College of Rheumatology) Control group: healthy Exclusion Criteria: edentate be total, have been subjected to surgical procedure in the last six months in the region of the hands or oral maxillo facial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| rheumatoid arthritis group<br>75 patients with rheumatoid arthritis | |
| control group<br>75 healthy women | |

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
-----------------
rheumatoid arthritis, bite force, grip strenght, oral health, quality of life
Prognostic Impact of PMI in Stable CAD Undergoing PCI

Study Overview
=================
Brief Summary
-----------------
This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.

Official Title
-----------------
The Prognostic Impact of Periprocedural Myocardial Injury in Stable Coronary Artery Disease Patients Undergoing Elective Percutaneous Coronary Intervention

Conditions
-----------------
Periprocedural Myocardial Injury, Coronary Artery Disease, Percutaneous Coronary Intervention

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: underwent elective coronary stenting patients permit informed consents Exclusion Criteria: acute STEMI NYHA class III-IV heart failure moderate-to-severe valvular disease missing post-PCI troponin results active infection, respiratory failure liver dysfunction (liver enzyme >3xURL or bilirubin >2xURL), malignancy and systemic connective tissue disease unable to get a informed consents

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PMI<br> | |
| non-PMI<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac events | cardiac death, target vessel revascularization, target lesion revascularization, non-fatal myocardial infarction, heart failure, angina pectoris | 12 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of inflammatory factors | Serum level of inflammatory factors including TNFα, IL-6 and so on. | 1 day after PCI |
S9304A Study of Protein Expression in Tumor Tissue Samples From Patients With Stage II or Stage III Rectal Cancer Enrolled in Clinical Trial SWOG-9304

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at protein expression in tumor tissue samples from patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.

Detailed Description
-----------------
OBJECTIVES: Determine expression levels of thioredoxin-1 (Trx-1), thioredoxin-interacting protein (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α) in paraffin-embedded resected tumor tissue samples from patients with stage II or III rectal cancer enrolled in clinical trial SWOG-9304. Determine if there is a correlation between Trx-1 and TXNIP expression and HIF-1α expression. Correlate expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence. Determine interactions for patient age, performance status, and type of therapy received on clinical trial SWOG-9304. OUTLINE: This is a multicenter study. Paraffin-embedded resected tumor tissue samples are analyzed for protein expression levels (thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha) by tissue microarray and immunostaining.

Official Title
-----------------
Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the rectum Stage II or III disease No metastases Enrolled on clinical trial SWOG-9304 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha |  | upon testing of specimens | 
| Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence |  | upon provision of expression to Statistical Center | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
A Phase III Study of Entecavir vs Lamivudine in Chronic Hepatitis B Subjects With Incomplete Response to Lamivudine

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the safety and effectiveness of switching to entecavir compared to continued lamivudine in patients with chronic hepatitis B.

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

Intervention / Treatment
-----------------
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of HBeAg-positive chronic hepatitis B infection; Incomplete response to current lamivudine therapy; HBeAg-positive; Absence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV); Absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.

Official Title
-----------------
A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Drug: Darifenacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with overactive bladder who completed a previous darifenacin short-term trial. Patients capable of independent toileting and able of independently completing the patient diary. Exclusion Criteria: Patients in whom the use of anticholinergic drugs was contraindicated Evidence of severe liver disease Patients with other clinically significant urinary or gynecological conditions Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin 7,5 mg tablets, Darifenacin 15 mg tablets administered once daily<br>* Other names: Enablex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term efficacy on the symptoms of overactive bladder |  |  | 
| King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24), |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment