linjc16/ctgov huggingface dataset:
Evolution® Biliary Stent System Clinical Study

Study Overview
=================
Brief Summary
-----------------
The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.

Official Title
-----------------
Palliation of Biliary Neoplasms With the Cook Evolution® Biliary Stent System

Conditions
-----------------
Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Biliary Tract, Stents

Intervention / Treatment
-----------------
* Device: Evolution® Biliary Stent - Uncovered


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is considered a candidate for stent placement based on institutional guidelines and product IFU. Exclusion Criteria: Patient is less than 18 years of age. Patient is unable or unwilling to provide written informed consent. Patient is unable or unwilling to comply with the follow-up schedule.

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 |
| --- | --- |
| Evolution® Biliary Stent - Uncovered<br> | Device: Evolution® Biliary Stent - Uncovered<br>* Commercially available device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from symptomatic recurrent biliary obstruction requiring reintervention |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success is defined as a stent successfully delivered and placed at its intended location at the end of the procedure. | Immediately following completion of the stent placement procedure | 
| Incidence of device-related adverse events |  | 6 months | 
| Ease of use | Ease of use will be evaluated on a five point scale ranging from very easy to very difficult. | Immediately following completion of the stent placement procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biliary Tract Neoplasms, Neoplasms, Gastrointestinal Diseases, Digestive System Diseases, Biliary Tract, Stents
Dexamethasone and Lower Extremity Block Duration

Study Overview
=================
Brief Summary
-----------------
Dexamethasone has shown to prolong upper extremity blocks. No one ha studied its effect on lower extremity blocks. The study would evaluate that point.

Conditions
-----------------
Analgesia Duration

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 foot surgery no contraindication to regional anesthesia Exclusion Criteria: opioid dependent chronic pain condition peripheral neuropathy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Plain bupivacaine | Drug: Bupivacaine<br>* Control<br>|
| Experimental: Experimental<br>Bupivacaine with Dexamethasone | Drug: Dexamethasone<br> <br> Drug: Bupivacaine<br>* Control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in the Duration of Block |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
popliteal block, analgesia duration
A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Study Overview
=================
Brief Summary
-----------------
Facilitated access to everolimus until it is commercially available and reimbursable by appropriate parties

Detailed Description
-----------------
This is a treatment protocol designed only to provide access to everolimus (RAD) for maintenance immunosuppression. The objectives are to facilitate the management of patients on maintenance immunosuppression therapy who are completing everolimus trials, To provide everolimus maintenance therapy through this access program and To collect and review safety data for up to 120 months or until the project has been discontinued whichever comes first. To collect and review safety data for up to 120 months or when Certican is commercially available in the given indication and reimbursed by appropriate payors or the project has been discontinued whichever comes first.

Official Title
-----------------
A Facilitated Access Program to Provide Everolimus (RAD) Maintenance for Patients Completing Therapy in RAD Trials in Solid Organ Transplantation

Conditions
-----------------
Organ Transplantation

Intervention / Treatment
-----------------
* Drug: everolimus (RAD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female recipients of solid organ transplants Subject is currently enrolled in an everolimus (RAD) trial sponsored by Novartis Currently on investigational drug everolimus (RAD) therapy Exclusion Criteria: Inability or unwillingness to comply with immunosuppressive regimen. Pregnancy. History of acute organ rejection within the last 3 months. Other protocol-defined inclusion/exclusion criteria may apply.

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 |
| --- |
|Drug: everolimus (RAD)|Everolimus|

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
-----------------
Kidney, heart, lung, liver, pancreas
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

Conditions
-----------------
Post-Menopausal Osteopenia

Intervention / Treatment
-----------------
* Drug: ibandronate [Bonviva/Boniva]
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-menopausal women, aged 55-75 years; diagnosed osteopenia. Exclusion Criteria: history of osteoporotic vertebral fracture; contraindication to ibandronate.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 150mg po monthly for 2 years<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* po monthly for 2 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trabecular BV/TV at distal radius of non-dominant arm |  | 12 arms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trabecular BV/TV at distal radius of non-dominant arm |  | 6 months and 2 years | 
| Bone density, trabecular BV/TV at distal tibia |  | 6 months, 1 and 2 years | 
| Serum CTX |  | Intervals throughout study | 
| Lumbar hip and wrist BMD |  | 1 and 2 years | 
| AEs and laboratory parameters |  | Throughout study |
Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to choose the preferred treatment modality for multiple, small hepatocellular carcinomas.

Detailed Description
-----------------
To compare the below things between PEIT group and TACE group Survival 5 year overall survival rate Disease free survival rate Recurrence a. recurrence rate

Official Title
-----------------
A Multicenter, Randomized, Controlled Trial of the Effective Therapy for Multiple, Small Hepatocellular Carcinomas: Comparing Transarterial Chemoembolization With Percutaneous Ethanol Injection Therapy.

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Transarterial chemoembolization
* Procedure: Percutaneous ethanol injection therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The evidences of HBV(+) &/or HCV(+) infection or liver cirrhosis Two to three tumor nodules with Child-Pugh classification A or single to three tumor nodules with Child-Pugh classification B The maximal, longest diameter of tumor mass measured by CT finding should be less than 2 cm. 1) Only for newly detected HCCs which were not treated before or 2) If treated before, it should be noted that there is no evidence of recurrence within the latest 6 months and, and also it should be remotely recurred more than 2cm apart from primary lesion. It should be compatible with the typical findings of HCCs radiologically(MD CT or dynamic MRI) Exclusion Criteria: In case of hepatic vein or portal vein invasion radiologically(CT or MRI)

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: chemotherapy<br>Transarterial chemoembolization (TACE) | Procedure: Transarterial chemoembolization<br>* lipiodol, adriamycin and/or mitomycin<br>* Other names: TACE;|
| Active Comparator: ethanol<br>Percutaneous ethanol injection therapy (PEIT) | Procedure: Percutaneous ethanol injection therapy<br>* 99% ethanol 2-4cc per one session, two to three sessions per single procedure for one week<br>* Other names: PEIT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival rate and recurrence rate |  | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, TACE, PEIT
A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.

Official Title
-----------------
A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History (within the past 24 months) of allergic conjunctivitis. Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug. Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1). Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Contraindications or hypersensitivity to the use of the study medication or its components. Inability or unwillingness to follow all study instructions and complete study visits as required. Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit. A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye). Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination. Other protocol-defined exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pataday<br>Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week | Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%<br>* Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week<br>* Other names: Pataday;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Patient Satisfaction | As assessed by the subject on a questionnaire | Day 7 |
Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.

Official Title
-----------------
Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection) (PREDICTIVE™ 303)

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

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months; BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Exclusion Criteria: Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors. Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months. Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator

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: insulin detemir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the change from baseline to end of treatment |  | after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneously reported adverse events during the trial |  |  | 
| Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am) |  |  | 
| FPG during the trial (central laboratory) at Visit 2 and Visit 3 |  |  | 
| Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3 |  |  | 
| Insulin detemir doses at Visit 2 and Visit 3 |  |  | 
| Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3 |  |  |
Inner and Middle Ear Effects of Hyperbaric Oxygen Thrapy

Study Overview
=================
Brief Summary
-----------------
Audiological evaluation performed to patients on hyperbaric oxygen therapy to see its effects on middle ear pressure

Detailed Description
-----------------
Thirty patients will be recruited from center pf hyperbaric oxygen therapy Every patient who received HBOT was submitted for Demographic data:age,gender,condition raquiring HBOT,use of analgesics,history of diabets ,cardiovascular or respiratory disease ,psychatric illness,smoking history facial/ENT problems and previous HBOT problems then tympanometry and basic pure tone audiometry including air and bone conduction is done following each of the first five treatment

Official Title
-----------------
Inner and Middle Ear Effects of Hyperbaric Oxygen Therapy

Conditions
-----------------
Otitic Barotrauma

Intervention / Treatment
-----------------
* Drug: Hyperbaric oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients above 18 years old already recieving hyperbaric oxygen therapy for treatment of other medical conditions required treatment by it as in diabetic foot Exclusion Criteria: patients who already had tympanostomy tubes

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- |
| HBO Group<br>Patients already recieving hyperbaric oxygen therapy for treatment of other medical conditions requiring it as in diabetic foot , cerebral infarctions | Drug: Hyperbaric oxygen<br>* Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing in middle ear pressure | Measuring middle ear pressure before exposure ro hyperbaric oxygen and following each of the first five treatments | Through completion of study after 2 years |
Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the correlation among magnetocardiography (MCG) patterns and various known cardiovascular risk factors.

Detailed Description
-----------------
It is well understood that diabetes mellitus (DM) causes various micro- and macrovascular complications. Among them, coronary heart diseases (CHDs) claim most mortality, and diabetes has been considered as CHD equivalent. Furthermore, the risk of CHD has been noticed to increase in the pre-diabetic stage, suggesting the development of CHD may start in a rather early stage of the disease. Thus, early detection of CHD in diabetic patients seems to be important. However, currently exam methods for CHD in diabetic patients seemed to have their limitations. Developed in the 1960s, magnetocardiography (MCG) is designed to detect the weak magnetic field generated by the electrical activity of the heart, and has been used widely in the study of fetal cardiac electrophysiology, arrhythmia and ischemic heart disease. However, the MCG pattern in diabetic patients is not fully understood. The aim of the study is to clarify the correlation among various cardiovascular risk factors and MCG pattern in diabetic patients. And, according to the results of the study, we'll evaluate the potentiality of MCG in early diagnosis of CHD in diabetic patients.

Official Title
-----------------
Research on the Correlation Among Magnetocardiography Patterns and Known Cardiovascular Risk Factors in Diabetic Patients

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clear consciousness Met the diagnostic criteria of DM published by the American Diabetes Association in 2009 Exclusion Criteria: not suitable for MCG exam (ex. with pacemaker implantation or indwelling metallic device)

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 |
| --- | --- |
| Diabetes mellitus<br>The Diabetic patient who receives follow-up at NTUH diabetics caring network | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The smooth index of corrected QT interval (SIQTC) measured by MCG |  | as the MCG exam is over | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Coronary heart disease, Magnetocardiography