linjc16/ctgov huggingface dataset:
Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease

Study Overview
=================
Brief Summary
-----------------
Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones. Methods: Fifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.

Detailed Description
-----------------
The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively. Urological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.

Official Title
-----------------
Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study

Conditions
-----------------
Biliary Stones

Intervention / Treatment
-----------------
* Procedure: percutaneous transhepatic choledochoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complete records Exclusion Criteria: lost follow up

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: percutaneous transhepatic choledochoscopy|percutaneous transhepatic choledochoscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptoms | success rate of biliary stone clearance or asymptomatic derbies | at least one year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasound | evidence of stone clearance | one month |
Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate new computer software on breast magnetic resonance imaging (MRI). The information from this study may help doctors and scientists develop better ways to find breast cancer, and may help future patents with cancer.

Official Title
-----------------
Newer Breast MRI Sequences for the Evaluation of Breast Cancer -FIESTA, Vibrant-DE and IDEAL: Feasibility Evaluation

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

Intervention / Treatment
-----------------
* Procedure: new software sequences, FIESTA and Vibrant-DE and IDEAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients over the age of 21 undergoing a diagnostic Breast MRI. Exclusion Criteria: Patients who would be normally excluded from undergoing an MRI examination Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field. Patients under the age of 21. Female patients who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

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: women undergoing routine breast MRI<br>Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients. | Procedure: new software sequences, FIESTA and Vibrant-DE and IDEAL<br>* Conventional images will be taken using the standard sequences consisting of T2-weighted imaging and T1-weighted imaging before and after contrast; these will be used for the diagnostic examination. FIESTA will be performed on 50 patients, while Vibrant-DE and IDEAL will be performed on the other 50 patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility of three new pulse sequences for breast MRI using newly developed software; FIESTA, Vibrant DE and IDEAL |  | conclusion of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantitatively and qualitatively assess performance of the three breast pulse sequences, and compare these results with the same parameters on standard breast MRI sequences. |  | conclusion of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vibrant-DE, IDEAL, MRI, Breast, 07-091
A Study to Test Lung Function After Radiation Therapy

Study Overview
=================
Brief Summary
-----------------
It is known that radiation damages lung tissue. New human studies at University of Iowa show that the radiation damage is not as expected. The purpose of this study is to document lung function using four-dimensional computed tomography (CT) and quantify changes three months after radiation therapy for malignant lung disease.

Official Title
-----------------
Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue

Conditions
-----------------
Lung Neoplasms, Neoplasm Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of small cell or non-small cell lung cancer or metastatic tumor to the lung being scheduled for localized radiation therapy (including radiosurgery) No prior or future planned surgery for the treatment of the lung cancer. Age ≥ 18 years Karnofsky 60% Not pregnant. Ability to understand and the willingness to sign a written informed consent document Ability and willingness to participate in breathing training and compliance wiht breathing apparatus so that radiation doses are optimally linked to 4D-CT images Ability to tolerate CT contrast Exclusion Criteria: No prior thoracic radiotherapy will be permitted Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women Severe COPD that requires chronic prednisone or multiple inhalers Underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis) Oxygen dependence at baseline Recent lung surgery or abdominal surgery (within 3 weeks) that would compromise respiratory pattern.

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 |
| --- | --- |
| Lung Radiation<br>Patients with tumors in the lung that require radiation therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry correlated to lung expansion maps |  | 3 months post radiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiation, Tomography, Spiral Computed, Four-Dimensional Computed Tomography, Respiratory Function Tests
Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects

Official Title
-----------------
A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Co-administration of DWC20155 and DWC20156
* Drug: DWJ1386 Tab.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI≥18.5 and ≤27.0 kg/m2 No clinically significant findings Age 19-55 years at screening Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test/Reference Drug<br>DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab. | Drug: Co-administration of DWC20155 and DWC20156<br> <br> Drug: DWJ1386 Tab.<br> <br> |
| Experimental: Reference/Test Drug<br>co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab. | Drug: Co-administration of DWC20155 and DWC20156<br> <br> Drug: DWJ1386 Tab.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | 0-24 hours | 
| Area under the plasma concentration versus time curve (AUC) |  | 0-24 hours |
Lifestyle Intervention in Obesity, Effect on Diabetes

Study Overview
=================
Brief Summary
-----------------
There are evidence from numerous studies on effect of lifestyle intervention in morbidly obese patients with type 2 diabetes. This study examines the effect of the Evje-model on type 2 diabetes. The Evje-model is a combined 12 months model, consisting of repeated stays in a specialist centre, telephone follow-up at home, home groups, self monitoring and close contact with the patients' local physician.

Detailed Description
-----------------
There will be done QOL-measures, blood- and urine analysis, weight, waist- and hip measurement, blood pressure and VO2-max measurement at baseline, after 6 months and after 12 months.

Official Title
-----------------
One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.

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

Intervention / Treatment
-----------------
* Behavioral: The Evje Model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with BMI > 35 with diagnosed type 2 diabetes Referred to Lifestyle Intervention from a public hospital Exclusion Criteria: Pregnancy Active major psychiatric disease(s) Active and serious eating disorder Drug- and/or alcohol dependency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: The Evje Model|nan|

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
-----------------
Obesity, Diabetes, Weight, Lifestyle, Follow up
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.

Official Title
-----------------
A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients

Conditions
-----------------
Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: JTT-130
* Drug: JTT-130 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have type 2 diabetes; Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2; Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable. Exclusion Criteria: Females who are pregnant or breast-feeding Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy; Acute coronary syndrome or uncontrolled hypertension; Does not meet medication restriction criteria, as described in the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 JTT-130<br> | Drug: JTT-130<br>* Tablets<br>|
| Experimental: Dose 2 JTT-130<br> | Drug: JTT-130<br>* Tablets<br>|
| Experimental: Dose 3 JTT-130<br> | Drug: JTT-130<br>* Tablets<br>|
| Placebo Comparator: Placebo<br> | Drug: JTT-130 Placebo<br>* Tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated hemoglobin (HbA1c) levels |  | End of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability data |  | End of Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes
Blood Test to Measure DNA Damage in Blood

Study Overview
=================
Brief Summary
-----------------
To check the radiosensitivity level in individual patients based on their DNA damage level.

Official Title
-----------------
Gamma-H2AX as a Molecular Predictor of Prostate Cancer Radiosensitivity

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate cancer diagnosis undergoing radiotherapy agree to participate in study Exclusion Criteria: not willing to participate not undergoing radiotherapy
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood test|nan|

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
-----------------
prostate cancer, gamma H2AX, radiosensitivity
Digital Sizing for Orthopaedic Hip Implants

Study Overview
=================
Brief Summary
-----------------
Hip implants come in different sizes. Currently, surgeons predict the implant size that will be needed using an analogue method whereby photos of the implant sizes are overlaid on the x-rays. In this study, we propose to use a digital, computerized method of templating which we expect will be more accurate than the overlay method.

Official Title
-----------------
Photo-manipulation of Digital Radiographs and Digitized Templates as a Method for Preoperative Sizing of Total Hip Arthroplasties

Conditions
-----------------
Hip Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients booked for primary total hip arthroplasty with non-cemented prosthesis. No previous surgery/fractures to acetabulum or femur or hip. No gross bony abnormality except for osteoarthritis and avascular necrosis. Exclusion Criteria: Cancer or tumor suspected, morbid obesity, revision, previous acetabular/femur/hip surgery, gross bony deformity, calibration bar not completely pictured on radiograph, unsuccessful surgery fracture/cancer/cemented prosthesis used.
Sexes Eligible for Study
-----------------
All

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip arthritis, implant sizing
Caries Management by Risk Assessment in Children

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the University of California, San Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.

Official Title
-----------------
Caries Management by Risk Assessment in Children

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Other: xylitol mints and fluoride varnish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be: Patients of record at the Tenderloin community and UCSF pediatric dental clinics 5-9 years old 3. Be able to give informed assent, consent and answer questionnaires in English, Spanish or Chinese by parents or guardian 4. Be unlikely to move from the area during the study period 5. Be willing to participate regardless of group assignment and comply with all study procedures Exclusion Criteria: Persons with: Prolonged antibiotic use in the past three months. Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 9 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Conventional pediatric dental care. | Other: xylitol mints and fluoride varnish<br>* Subjects in the intervention group will receive additional diet, oral hygiene handouts, more frequent professional fluoride application, and xylitol mints based on their caries risk levels.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| new decayed surfaces |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cariogenic bacteria levels |  | 6 month and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental caries, children, mutans streptococci, lactobacilli, cariogenic bacteria
Pilot to Assess DBE as a Rescue Technique for Failed PEJ

Study Overview
=================
Brief Summary
-----------------
Is DBE(double balloon enteroscopy)-assisted DPEJ(direct percutaneous endoscopic jejunostomy) a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

Detailed Description
-----------------
DBE-assisted DPEJ is a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

Official Title
-----------------
A Pilot Study to Assess the Feasibility of Double Balloon Enteroscopy as a Rescue Technique for Failed Direct Percutaneous Endoscopic Jejunostomy Tube Placement

Conditions
-----------------
Patients Who Have Failed Conventional DPEJ Placement

Intervention / Treatment
-----------------
* Procedure: DBE PEJ placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients: Patients who have failed conventional DPEJ tube placement will be offered participation in the study. DBE-assisted DPEJ will be performed on a subsequent day following failed DPEJ. Patients who do not wish to undergo an attempt at DBE-assisted DPEJ will follow-up with their primary caregiver for alternative means of feeding tube placement (e.g., surgical jejunostomy). Inclusion criteria: Age > 18 years old Appropriate indication for DPEJ tube placement and Nutrition consult approval Absence of bleeding disorder Platelet count > 50,000 and INR < 1.5 Ability to give informed consent

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 |
| --- | --- |
| PEJ placement<br>Patients who have failed conventional DPEJ placement and would otherwise require surgical intervention. | Procedure: DBE PEJ placement<br>* One time procedure with follow-up telephone call.<br>|

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

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