linjc16/ctgov huggingface dataset:
Evaluation of Pancreatic Pseudocyst Drainage With a Metal Stent

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the evaluation of the effectiveness of endoscopic Pancreatic Pseudocyst drainage using a metal stent.

Official Title
-----------------
Prospective Evaluation of the Clinical Utility of Pseudocyst Drainage With Metal Stent

Conditions
-----------------
Pancreatic Pseudocysts

Intervention / Treatment
-----------------
* Procedure: Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18 years or older Subject has pancreatic pseudocyst Subject has medical indication for drainage of the pancreatic pseudocyst Subject must be able to give informed consent Exclusion Criteria: Any contraindication to endoscopic pseudocyst drainage Subject is unable 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 |
| --- | --- |
| Pancreatic Pseudocysts<br>All adult patients who have a clinical indication to undergo an endoscopic drainage of a pancreatic pseudocyst. | Procedure: Endoscopy<br>* Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success of Endoscopic Ultrasound-guided Single-access Pseudocyst Drainage With a Fully Covered Self-expanding Metal Stent ; Anchored With a Double Pigtail Plastic Stent Inserted Through the Metal Stent Lumen | Technical success was evaluated by the ability to achieved pseudocyst drainage after endoscopically placing a Fully Covered Self-expanding Metal Stent in the pseudocyst . Technical failure was evaluated by the inability to fully drain the pancreas pseudocyst after endoscopically placing a Fully Covered Self-expanding Mental Stent in the pseudocyst. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Pancreatic Pseudocyst After Placement of Fully Covered Self-expanding Metal Stent (CSEMS). |  | 6 to 12 weeks after baseline | 
| Adverse Events |  | 1 year |
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study

Official Title
-----------------
Efficacy and Safety of Combination Therapy of Rosuvastatin and Fenofibrate Versus Rosuvastatin Monotherapy in Mixed Dyslipidemia Patients

Conditions
-----------------
Mixed Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Fenofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19   80 years old High risk patient to Coronary Heart Disease At Visit 1(Screening) Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl Exclusion Criteria: AST or ALT > 2X ULN Patients with uncontrolled hyperthyroidism (TSH>1.5X ULN) Patients with uncontrolled diabetes (HbA1c ≥ 9%) Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg) Patients with congestive heart failure(NYHA class III IV) or uncontrolled arrhythmia within 6 months Patients treated with any investigational drugs within 3 months at the time consents are obtained Not eligible to participate for the study at the discretion of investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Rosuvastatin 10 mg, Fenofibrate 160 mg | Drug: Rosuvastatin<br>* Rosuvastatin 10 mg, qd, po<br>* Other names: Crestor Tab.;Drug: Fenofibrate<br>* Fenofibrate 160mg, qd, po<br>* Other names: Lipidil supra Tab.;|
| Active Comparator: Comparator<br>Rosuvastatin 10 mg | Drug: Rosuvastatin<br>* Rosuvastatin 10 mg, qd, po<br>* Other names: Crestor Tab.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percent change of Non-HDL Cholesterol |  | from baseline at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change, percent change of Non-LDL-C |  | from baseline at week 4 | 
| The mean change of Non-LDL-C |  | from baseline at week 8 | 
| The mean percent change of LDL-C, HDL-C, VLDL-C, TG, TC, Apo-AI, Apo-B |  | from baseline at week 4, 8 | 
| The achievement rate of Non-HDL-C<130mg/dl |  | from baseline at week 4, 8 |
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.

Official Title
-----------------
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

Conditions
-----------------
ACC/AHA/NASPE Class 1, IIa or IIb Indications

Intervention / Treatment
-----------------
* Device: subcutaneous implantable defibrillator (S-ICD) system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Replacement of an existing implanted transvenous ICD system Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system Age is >= 18 years Appropriate pre-operative ECG as measured with a specially developed template Exclusion Criteria: Subjects unable or unwilling to provide informed consent Any condition which precludes the subject's ability to comply with the study requirements Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor. Patients with a serious medical condition and life expectancy of less than one year. Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR <= 29.

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: S-ICD System<br> | Device: subcutaneous implantable defibrillator (S-ICD) system<br>* implantable defibrillator system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion of Induced Ventricular Fibrillation | The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation. | Testing done during the implant procedure |
Effect of Passive Leg Raise for Pediatric Peripheral IV Placement

Study Overview
=================
Brief Summary
-----------------
The investigators wish to determine whether passive leg raise allows for easier peripheral vascular access in the pediatric population. The investigators hypothesize that pediatric anesthesiologists will have higher rates of successful intravenous catheterization in children where a passive leg raise is employed.

Official Title
-----------------
Effect of Passive Leg Raise for Pediatric Peripheral IV Placement

Conditions
-----------------
Intravenous Access

Intervention / Treatment
-----------------
* Procedure: Passive leg raise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric participants undergoing dental procedures under general anesthesia Exclusion Criteria: Children who already have adequate IV access

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 14 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: Passive leg raise<br>Participant's legs will be raised with a bolster prior to IV insertion. | Procedure: Passive leg raise<br>* A baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered.<br>|
| No Intervention: No leg raise<br>Participants will lie flat prior to IV insertion. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in peripheral vein diameter | Change between vein diameter at baseline and following group allocation. | at 5 minutes |
EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia Patients

Study Overview
=================
Brief Summary
-----------------
Continuous measurement of breathing patterns, heart rate, restlessness and cough in sleep using EarlySense ES 16 device. Predicting worsening in COPD patients' condition using the above parameters.

Detailed Description
-----------------
Study's participants are CHF, COPD and Pneumonia patients or patients who are otherwise hospitalized in internal medicine department. During the study the patients' breathing patterns, heart rate, restlessness and cough in sleep will be measured by the EarlySense ES 16 device, which is placed in the patients' bed. Patients' clinical status are followed. The patient's clinical condition is followed and analyzed in comparison to the EarlySense system output in order to determine the capability of the EarlySense system to predict COPD, CHF or Pneumonia deteriorations.

Official Title
-----------------
EarlySense Monitoring Device Evaluation on Patients in Med / Surg

Conditions
-----------------
COPD Patients

Intervention / Treatment
-----------------
* Device: Earlysense vital sign monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CHF, COPD and Pneumonia Patients or control group non respiratory patients 18 years old and up Able to perform spirometry test or connect to ECG, respiratory belt, SPO2 Willing to sign consent form Home close to Tel Aviv Exclusion Criteria: hospitalization within the passing year

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Earlysense vital sign monitor|The system is a contactless system that measures heart and respiratory rates and other parameters via a contactless sensor that is placed under the patient mattress|

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
-----------------
COPD, Respiration Rate, Monitoring
Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles

Study Overview
=================
Brief Summary
-----------------
GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: triptorelin acetate
* Drug: NaCl %0.9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI. Embryo transfer performed on day 3 Exclusion Criteria: Participation in another trial that was being conducted in our unit at the same time. Preimplantation genetic screening cycles. Day 5 embryo transfers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH agonist<br> | Drug: triptorelin acetate<br>* single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer<br>|
| Placebo Comparator: Saline<br> | Drug: NaCl %0.9<br>* 0.1 ml sterile saline sc injection 3 days after embryo transfer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy beyond 20th gestational week |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  |  | 
| Embryo implantation rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GnRH agonist, GnRH antagonist, IVF, ICSI, assisted reproduction, luteal phase
Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases

Study Overview
=================
Brief Summary
-----------------
Circulating tumour DNA (ctDNA) is a promising tool when monitoring the residual disease in colorectal cancer (CRC). Current staging procedures are insufficient to identify the patient cohort at high risk, who might benefit from additional adjuvant therapy. We will show that the assessment of ctDNA is a non-invasive approach and easily taken at different time points via simple blood draw to monitor residual disease from the colorectal cancer patients after primary surgery. Minimal residual disease could be used in the future for individualized treatment decisions after primary surgery.

Official Title
-----------------
Measuring Molecular Residual Disease in Colorectal Cancer After Primary Surgery and Resection of Metastases

Conditions
-----------------
Colorectal Cancer, Residual Disease

Intervention / Treatment
-----------------
* Diagnostic Test: blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned colorectal primary surgery Exclusion Criteria: unfit patients with dementia
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: CRC patients after primary surgery<br>sequential blood draw taken to monitor residual disease | Diagnostic Test: blood draw<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ctDNA level | residual disease measured by sequential blood draws | 3-6 months |
Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra

Study Overview
=================
Brief Summary
-----------------
Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent

Official Title
-----------------
A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One Trabecular Micro-bypass Stent and One Suprachoroidal Stent

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: Cataract surgery plus one iStent and one iStent Supra implanted


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae Exclusion Criteria: Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma

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
Interventional Model Description: iStent and iStent Supra
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G1 plus G3 with phaco<br>Cataract surgery via phacoemulsification followed by implantation of one iStent and one iStent Supra | Device: Cataract surgery plus one iStent and one iStent Supra implanted<br>* Cataract surgery via phacoemulsfication plus one iStent and one iStent supra<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 20% IOP reduction from baseline | IOP measured via Goldmann tonometry in mm Hg and compared to baseline IOP | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP less than or equal to 18 mm Hg | IOP measured via Goldmann tonometry in mm Hg | Month 12 |
Anti-Aggregative Therapy and Laser Iridectomy

Study Overview
=================
Brief Summary
-----------------
Our study investigates the effect of anti-aggregative treatment on success and complications of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow angles.Patients will undergo first laser treatment with the anti-aggregative treatment and will scheduled for next lase in the other eye after discontinuing the anti-aggregative treatment. The patients will be followed-up for 3 months.

Conditions
-----------------
Eyes With Narrow Angle

Intervention / Treatment
-----------------
* Drug: The cessation of anti-aggregative treatment for 10 days


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with narrow angle that need laser iridectomy and take anti- aggregative treatment over 20 years old patients who can stop their anti-aggregative treatment for 10 days Exclusion Criteria: under coumadin treatment post ocular surgeries

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: The cessation of anti-aggregative treatment for 10 days|nan|

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

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