linjc16/ctgov huggingface dataset:
Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

Study Overview
=================
Brief Summary
-----------------
CO2 insufflation instead of air for colonic distension in colonoscopy is considered to reduce pain after and during colonoscopy. There is limited data, that Co2 is similar effective in sedated patients. Furthermore it had not been investigated if patient's compliance for participating in cancer screening could be improved by using Co2. The aim of the study is to assess postoperative pain and satisfaction after colonoscopy by comparing C02 with air.

Official Title
-----------------
Randomized Controlled Trial Comparing Co2 vs. Air in Colonoscopy in Sedated Patients

Conditions
-----------------
Pain, Satisfaction

Intervention / Treatment
-----------------
* Other: Air insufflation use in colonoscopy
* Other: CO2 use in colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients, who are assigned to an outdoor ambulance for elective colonoscopy in sedation Between 18 and 90 years Exclusion Criteria: COPD Dementia

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2<br>Air insufflation in colonoscopy | Other: Air insufflation use in colonoscopy<br>* Air insufflation for colonic distension<br>|
| Other: 1<br>CO2 insufflation in colonoscopy | Other: CO2 use in colonoscopy<br>* Co2 insufflation for colonic distension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after Colonoscopy measured by 100mm visual analogue scale. |  | 15 and 30 minutes and 6 h and 12 h after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients satisfaction (VAS) and its benefit in regard to cancer screening (2 questions) |  | 30 minutes and 6 hours after colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CO2, pain, colonoscopy, cancer, screening
Experience in Predicting Decision Making for Receiving Treatment in Acute Coronary Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the predictability of cognitive representation, emotional responses, and hospitalization experience toward the decision to receive treatment of the acute coronary syndrome patients.

Official Title
-----------------
Cognitive Representation, Emotional Responses and Hospitalization Experience in Predicting Decision Making for Receiving Treatment Among Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute coronary syndrome Patients who had first experience or recurrent acute coronary syndrome Exclusion Criteria: Still have chest pain within 24 hours ago Cognition or communication disorder or having psychotic or neurologic symptoms

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 |
| --- | --- |
| Acute coronary syndrome<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
One Touch VerioIQ US Clinical Outcomes Study

Study Overview
=================
Brief Summary
-----------------
Evaluation of the clinical benefits of One Touch VerioIQ system

Detailed Description
-----------------
Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Official Title
-----------------
One Touch VerioIQ US Clinical Outcomes Study

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: One Touch VerioIQ Blood Glucose Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female at least 18 to 80 years old ADA guidelines for FPG and PPG appropriate A1C greater or equal to 8.0% and less than or equal to 10.5% lab A1C greater than or equal to 8.0% in the last 6-12mths Diagnosed with type 1 or 2 in at least last 1 year on stable dose of OADs for at least 3mths prior to screening willingness to test 7 BGM tests per day willing to remain on same therapy as baseline (MDI) for duration of study Exclusion Criteria: unlikely to be compliant to study procedures has or has currently used One Touch VerioIQ Is on fixed doses of insulin for MDI therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VerioIQ<br>Subjects replaced own Blood Glucose Monitoring system with VerioIQ. | Device: One Touch VerioIQ Blood Glucose Monitor<br>* BGM with pattern alert technology and with associated pattern guide<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C From Baseline to Week 24 | Change in A1C from baseline to week 24 | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C From Baseline to Week 12 | Change in A1C from baseline to week 12 | 12 weeks | 
| Change in FPG From Baseline to 24 Weeks and Over Time | Change in Fasting Plasma Glucose (FPG) from baseline to 24 weeks and over time | 24 weeks and over time | 
| Change in Proportion of Subjects With A1C Less Than or Equal to 7.0% at Week 24 |  | 24 weeks | 
| Change in 30 Day Mean Glucose Comparing First Month to Last Month After 24 Weeks |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood glucose monitor, Pattern management, Pattern guide, Education
A New Exogenous Marker for Diagnosis of Oxidative Stress During Laproscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes of oxidative stress. The investigators would like to assess the usefulness of this marker during positive pressure pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection (ischemia induced by intra-abdominal pressure and vascualr compromise).

Official Title
-----------------
A New Exogenous Marker for Diagnosis of Oxidative Stress During Laproscopic Surgery

Conditions
-----------------
Oxidative Stress, Laproscopy

Intervention / Treatment
-----------------
* Procedure: Taking blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy patients undergoing elective laproscopic cholecystectomy and patients undergoing operation for tumer of large intenstine. Exclusion Criteria: Patients suffering from Cardio Pulmonory and renal diseases

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 |
| --- | --- |
| Experimental: Experimental<br> | Procedure: Taking blood samples<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
-----------------
Oxidative Stress, Laproscopy
WatchPAT Compared to PSG at 8500'

Study Overview
=================
Brief Summary
-----------------
Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.

Detailed Description
-----------------
The efficacy of the WP200U will be evaluated by comparing it to the PSG manual scoring of sleep disordered breathing (SDB) parameter using the PSG manual scoring as a gold standard

Official Title
-----------------
Assessment of Sleep-related Respiratory Disorders at High Altitude With the WatchPAT200TMU Compared to PSG.

Conditions
-----------------
Sleep Disorder; Breathing-Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and females ≥ age 17yrs Subject is able to read understand and sign the informed consent form. Willing to sleep with the WP200U and PSG simultaneously in the sleep lab. Exclusion Criteria: Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study). Any condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient ability to complete the study.

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- | --- |
| Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG. |  | 8 months. |
Clinical Trial to Evaluate the Efficacy and Safety of YHP1701

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension

Conditions
-----------------
Hypertension and Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: YHP1701
* Drug: YHR1703
* Drug: YHR1704


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both man and woman who is over 19 years old Patient with dyslipidemia and hypertension Exclusion Criteria: sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg A history of cardiovascular disease Rhabdomyolysis, myopathy Hypertension or hypercholesterolemia due to secondary causes Uncontrolled diabetes Evidence of hepatic or renal disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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: YHP1701<br>PO, Once daily (QD), 8 weeks | Drug: YHP1701<br>* PO, Once daily (QD), 8 weeks<br>|
| Active Comparator: YHR1703<br>PO, Once daily (QD), 8 weeks | Drug: YHR1703<br>* PO, Once daily (QD), 8 weeks<br>|
| Active Comparator: YHR1704<br>PO, Once daily (QD), 8 weeks | Drug: YHR1704<br>* PO, Once daily (QD), 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of LDL-Cholesterol | LDL-Cholesterol | 0, 8 weeks | 
| Change of mean seated Systolic Blood Pressure | Blood Pressure | 0, 8 weeks |
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients

Study Overview
=================
Brief Summary
-----------------
Randomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus eluting Endeavor stent.

Official Title
-----------------
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Device: Endeavor
* Device: Cypher Select


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centers in Denmark can be included in the study. Exclusion Criteria: The patient will not participate The patient participates in other randomized stent studies Expected survival < 1 year Allergy to Aspirin, Clopidogrel or Ticlopidine Allergy to Sirolimus or ABT-578

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Zotarolimus eluting stent | Device: Endeavor<br>* Comparison of two different drug eluting coronary stents<br>* Other names: 1. Endeavor;|
| Active Comparator: 2<br>Sirolimus stent | Device: Cypher Select<br>* Comparison of two different drug eluting coronary stents<br>* Other names: 1. Cypher;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In a randomized study to compare the Endeavor and the Cypher Select coronary stents by assessing MACE (cardiac death, myocardial infarction, stent thrombosis and target vessel revascularization) after 9 months. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months. |  | 9 months |
Evaluate Safety, Efficacy and Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Detailed Description
-----------------
Patients will receive CT-P6 or Herceptin.

Official Title
-----------------
Double-blind Randomised Phase I/IIb Study

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

Intervention / Treatment
-----------------
* Drug: CT-P6
* Drug: Herceptin
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are females Have a Her 2 over-expression Have ECOG 0 or 1 Exclusion Criteria: Current clinical or radiographic evidence CNS metastases Current Known infection Pregnant or nursing mother

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-P6 & Paclitaxel<br>CT-P6 + Paclitaxel | Drug: CT-P6<br>* CT-P6: administered every 3 weeks<br>Drug: Paclitaxel<br>* Paclitaxel: administered every 3 weeks<br>|
| Active Comparator: Herceptin & Paclitaxel<br>Trastuzumab + Paclitaxel | Drug: Herceptin<br>* Herceptin: administered every 3 weeks<br>* Other names: Trastuzumab;Drug: Paclitaxel<br>* Paclitaxel: administered every 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter |  | months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK data, safety and efficacy |  | months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herceptin, Her 2-positive, metastatic breast cancer, CT-P6
Treatment of Adults With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
The objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study BPLG-005. In addition, further change in efficacy endpoints of BPLG-005 by prolonged treatment will be evaluated. Additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.

Official Title
-----------------
A Phase III, Open-label, Uncontrolled, Multicentre, Rollover Study to Assess Safety and Efficacy of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency

Conditions
-----------------
Pituitary Disorders, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: Growth hormone - LB03002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (male and female) who have completed the Visit 8 of preceding main study (BPLG-005) and are willing to continue their participation in an extension study If female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. A negative urine pregnancy test at Visit 0 is required for females of child-bearing potential Written informed consent of the patient Exclusion Criteria: Evidence of active malignancy or growth of a previously stable tumor Benign intracranial hypertension Clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease Non-compliance with medications, un-cooperativeness or drug abuse during the BPLG-005 study Patients who are not able to comply with the study protocol for any reason

Ages Eligible for Study
-----------------
Minimum Age: 23 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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LB03002 throughout<br>administered LB03002 for preceding 26 weeks | Drug: Growth hormone - LB03002<br> <br> |
| Experimental: Switched to LB03002<br>administered placebo for preceding 26 weeks | Drug: Growth hormone - LB03002<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events, antibody formation and local tolerability assessment after 1 year treatment from baseline of BPLG-005 |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth hormone Deficiency
Central Corneal Thickness in Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the central corneal thickness measurement in patients with exfoliation syndrome, exfoliative glaucoma, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma.

Detailed Description
-----------------
To compare the central corneal thickness measurement in patients with exfoliation, primary open-angle glaucoma, ocular hypertension and normal controls and to evaluate the value of corneal thickness in the diagnosis and management of glaucoma. Prospective study in progress. Randomly selected patients undergo a comprehensive ophthalmic exam which includes 2 separate pachymetry measurements in 2 different examinations at the same time of the day (10:00 am) with 3 different pachymeters. The values obtained are correlated with a number of other glaucoma parameters. A thinner cornea may represent a specific attribute and an additional risk factor for patients with exfoliation. Evaluation of corneal thickness is an important exam in the management of patients with exfoliation.

Official Title
-----------------
Central Corneal Thickness in Patients With Exfoliation Syndrome, Exfoliative Glaucoma, Exfoliative Glaucoma, Primary Open-angle Glaucoma and Ocular Hypertension

Conditions
-----------------
Exfoliation Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exfoliation material on pupil Intraocular pressure below 21 mm Hg without glaucomatous damage Intraocular pressure above 21 mm Hg without glaucomatous damage Raised intraocular pressure with glaucomatous damage Exclusion Criteria: Corneal disorders History of trauma Evidence of corneal abnormality that may influence IOP Contact lens use Corneal surgery

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 89 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 |
| --- | --- |
| primary open-angle glaucoma<br> | |
| ocular hypertension patients<br> | |
| normal controls<br> | |
| Exfoliation patients<br>patients with exfoliation syndrome or exfoliative glaucoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central corneal thickness |  | Morning measurement (10:00-11:00) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual field, scanning laser polarimetry |  | 10:00-11:00 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
corneal thickness, exfoliation