linjc16/ctgov huggingface dataset:
Real World Efficiency of Trastuzumab in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands. RESEARCH QUESTIONS / OBJECTIVES Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given? Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands? To address the research questions (objectives), the following outcome measures will be determined: CLINICAL OUTCOME MEASURES Actual trastuzumab administration as opposed to planned trastuzumab administration Selection criteria for chemotherapy and trastuzumab in daily practice Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac Disease-free, breast cancer specific, and overall survival in relation to trastuzumab ECONOMIC OUTCOME MEASURES Volumes and costs of diagnostic tests and therapies including those for (distant) relapse Cost-effectiveness of trastuzumab in clinical trials versus in real world

Official Title
-----------------
Real-world Use and (Cost)-Effectiveness of Adjuvant Trastuzumab in Early Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals. Exclusion Criteria: Distant metastasis at the time of the primary diagnosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with HER2 positive tumors<br>Patients with HER2 positive tumors treated with trastuzumab or not treated with trastuzumab | Drug: Trastuzumab<br>* Treatment with trastuzumab in HER2 positive patients<br>* Other names: Herceptin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the use of trastuzumab in patients with human epidermal growth factor receptor 2 (HER2) positive tumor | Disease free survival | events, within an average of 5-year between diagnosis and last follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients treated with trastuzumab who develop (cardio)toxicity? | cardiotoxicity | temporary or definite stop trastuzumab, within an average of 5-year between diagnosis and last follow up |
Study Evaluating Effexor XR for Major Depression.

Study Overview
=================
Brief Summary
-----------------
Study Evaluating Effexor XR for Major Depression.

Official Title
-----------------
Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Effexor XR
* Drug: Milnacipran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with major depression based on DSM-IV-TR Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of depressed mood at the baseline. Exclusion Criteria: Patients with schizophrenia or any other psychotic disorder Patients with history or presence of bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Effexor XR|nan|
|Drug: Milnacipran|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of total score of HAM-D17 between baseline and final-on-therapy. |  |  | 
| Remission rate of HAM-D17 at the final-on-therapy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression
Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

Study Overview
=================
Brief Summary
-----------------
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.

Detailed Description
-----------------
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.

Official Title
-----------------
CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment

Conditions
-----------------
Esophageal Lesion

Intervention / Treatment
-----------------
* Diagnostic Test: PillCam ESO Capsule Endoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation Adults aged 18 years and older Patients able to give informed consent Exclusion Criteria: Patients under the age of 18 Patient unable to or unwilling to swallow the capsule endoscopes Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices Pregnant or lactating females Subjects with history of abdominal, pelvic, or bowel surgery within the past year

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>PillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure. | Diagnostic Test: PillCam ESO Capsule Endoscope<br>* Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA |  | 14 Days |
Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male volunteers.

Detailed Description
-----------------
The number of patient is twenty-four.Patients were randomly assigned either DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL 300mg, qd) after eating foods.

Official Title
-----------------
A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: High fat meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 55 years of healthy volunteers Exclusion Criteria: Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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: High fat meal<br> | Dietary Supplement: High fat meal<br>* offer high fat-meal in the morning before drug intake.<br>* Other names: DP-R202 : DP11002-3;|
| Experimental: DP-R202<br>under fed condition | Dietary Supplement: High fat meal<br>* offer high fat-meal in the morning before drug intake.<br>* Other names: DP-R202 : DP11002-3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Pharmacokinetics(Cmax, AUClast) |  | 24h |
A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

Official Title
-----------------
A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce Cardiovascular Risk in Coronary Heart Disease (CHD) Patients With a Recent Acute Coronary Syndrome (ACS) Event and Type 2 Diabetes Mellitus (T2D)

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

Intervention / Treatment
-----------------
* Drug: Aleglitazar
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18 years of age Type 2 diabetes mellitus Hospitalization for ACS event and randomization between hospital discharge and 8 weeks after the ACS index event (day of hospitalization) Exclusion Criteria: Estimated glomerular filtration rate <45 mL/min/1.73m2 Concomitant treatment with a thiazolidinedione and/or fibrate Triglycerides >400 mg/dL Anaemia Symptomatic congestive heart failure classified as New York Heart Association (NYHA) class II-IV (France and Germany: Symptomatic congestive heart failure classified as NYHA class I-IV)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aleglitazar<br> | Drug: Aleglitazar<br>* aleglitazar 150 micrograms po daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* placebo control po daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on cardiovascular death, non-fatal myocardial infarction and non-fatal stroke |  | Throughout study, approximately 4.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on other cardiovascular endpoints |  | Throughout study, approximately 4.5 years | 
| Glycemic control, lipoprotein profile, blood pressure, biomarkers of cardiovascular risk |  | Throughout study, months 1, 3, 6, 9, 12 and then every 6 months thereafter | 
| Tolerability and long-term safety profile |  | Throughout study, approximately 4.5 years |
Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication

Study Overview
=================
Brief Summary
-----------------
We will evaluate the long-term changes of gastric H+, K+-adenosine triphosphatase (H+, K+-ATPase) and Interleukin-1B mRNA expression according to Helicobacter pylori (H.pylori) infection and intestinal metaplasia and investigate the long-term effect of H. pylori eradication

Detailed Description
-----------------
H. pylori suppresses gastric acid secretion by repressing gastric acid pump, H+, K+-ATPase, and stimulating Interleukin-1B. In this study, we will evaluate the expression of H+, K+-ATPase and Interleukin-1B mRNA according to H. pylori infection and intestinal metaplasia in controls and patients with gastric cancer. In addition, we observe the changes of H+, K+-ATPase and Interleukin-1B mRNA expression over 5 years after H. pylori eradication.

Official Title
-----------------
Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication

Conditions
-----------------
Helicobacter Pylori Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report Exclusion Criteria: Subjects with previous eradication treatment for H. pylori Subjects with previous gastrectomy

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 |
| --- | --- |
| H. pylori negative group<br>Subjects who have not have H. pylori infection, and had not receive H. pylori eradication | |
| H. pylorieradicated group<br>Subjects who have had H. pylori infection currently and received successful H. pylori eradication according to appropriated indication | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-1B and H+,K+-ATPase mRNA expression | Gastric Interleukin-1B and H+,K+-ATPase mRNA expression in subjects with and without H. pylori infection at baseline, and changes of Interleukin-1B and H+,K+-ATPase mRNA expression with time in subjects without H. pylori infection and subjects who underwent H. pylori eradication successfully. Gastric Interleukin-1B and H+,K+-ATPase mRNA expression measured by reverse transcription polymerase chain reaction, using the gastric mucosa specimen obtained during esophagogastroduodenoscopy | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, Interleukin-1 beta, Gastric H+, K+- APTase
Automated Phonocardiography Analysis in Adults

Study Overview
=================
Brief Summary
-----------------
Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists. Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III). Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist. Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.

Official Title
-----------------
Phonokardiographie Bei Erwachsenen

Conditions
-----------------
Aortic Insufficiency, Aortic Stenosis, Mitral Insufficiency, Mitral Insufficiency and Aortic Stenosis, Tricuspid Regurgitation, Insufficiency, Pulmonary, Insufficiency, Tricuspid

Intervention / Treatment
-----------------
* Device: Automated Heart Murmur Detection AI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with a heart defect verified by echocardiography

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

| Intervention/Treatment |
| --- |
|Device: Automated Heart Murmur Detection AI|Automated AI algorithm-based analysis of digital heart sound recordings to detect pathological heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. Algorithm results for each recording included: AHA classification (I pathologic versus III innocent/no murmur), murmur timing, murmur grade, heart rate and S1/S2 identification.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for pathological heart murmur detection | Ability to detect a pathological heart murmur in digital heart sound recordings obtained from an elderly population with heart valve disease. | 2 months |
Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire

Study Overview
=================
Brief Summary
-----------------
In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold standard in France for colorectal cancer screening in populations at risk. However, it has a number of limitations. The quality of the bowel preparation is a critical step for the successful completion of this examination. The occurrence of interval cancers raises the problem of missed lesions. A literature review showed that there were differences between the endoscopy units on quality standards for bowel preparation. The rate of unprepared colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516 colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008. The establishment a predictive score for quality of bowel preparation based on a self-administered questionnaire completed by patients during the pre-colonoscopy consultation, would help identify patients at risk of poor preparation in order to optimize the prescribed preparation in this consultation.

Official Title
-----------------
Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or woman > 18 years old Patient agreeing to participate in the study Prescription of a bowel preparation respecting the marketing authorization. Exclusion Criteria: Major patient under guardianship, or protected person, Pregnant woman, Patient who doesn't understand French or can't read People not affiliated with a social security scheme or of such a scheme

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 |
| --- | --- |
| patients undergoing colonoscopy<br> | Other: Questionnaire<br>* Self administered questionnaire to evaluate the preparation quality of colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score performance | score performance to predict a poor bowel preparation (defined by a score of Boston inferior or equal to 7 and / or a segment equal to 1) | within 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability of questionnaire | Acceptability of the questionnaire evaluated by the rate of return of the questionnaires and the rate of well completed questionnaires | end of study | 
| Adenoma detection | adenoma detection rate compared to Boston score | within 6 month |
IL 6 Measurement Using a New Densitometric Bedside (POC) Test

Study Overview
=================
Brief Summary
-----------------
In a equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements were compared to test results obtained with conventional ELISA analysis

Detailed Description
-----------------
In an equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes) that allows IL-6 measurements at the bedside. We then compared the respective test results to those obtained with conventional ELISA analysis

Conditions
-----------------
Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-90 Written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |