linjc16/ctgov huggingface dataset:
The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine whether the extract of green tea is effective on type 2 diabetes and hyperlipidemia.

Detailed Description
-----------------
Percent change Homa insulin resistance, cholesterol and triglycerol.

Official Title
-----------------
Taipei City Hospital, Taipei, Taiwan

Conditions
-----------------
Type 2 Diabetes, Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Green tea extract
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20--69 years old Type 2 diabetes for > one year TG >= 150 mg/dl or LDL >= 100 mg/dl Exclusion Criteria: GPT > 80 mg/dl Creatinine > 1.8 mg/dl Pregnancy AMI Stroke Operational or any not suitable patients diagnosis physician in charge

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| Placebo Comparator: B formula<br>placebo | Dietary Supplement: Placebo<br>* 500 mg . one capsule of placebo, 3 times per day<br>|
| Experimental: A formula<br>Green tea extract | Dietary Supplement: Green tea extract<br>* 500 mg . one capsule of green tea extract, 3 times per day<br>* Other names: EGCG: Green tea extract;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of HOMA insulin resistance and TG |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change of HbA1C and Cholesterol |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
green tea, EGCG, type 2 diabetes, hyperlipidemia
Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of laparoscopic cholecystectomy.

Detailed Description
-----------------
Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 30 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.

Official Title
-----------------
Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy

Conditions
-----------------
Evaluation Studies

Intervention / Treatment
-----------------
* Procedure: Laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults male and female age of or above 18 years Symptomatic chronic calculous cholecystitis Ultrasound confirmed Gall bladder stones Exclusion Criteria: Complicated chronic calculous cholecystitis Malignant Gall bladder

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 |
| --- | --- |
| Scoring factors<br> | Procedure: Laparoscopic cholecystectomy<br>* Surgical removal of Gall bladder using laparoscopy<br>|
| Difficulty criteria<br> | Procedure: Laparoscopic cholecystectomy<br>* Surgical removal of Gall bladder using laparoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy | Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy | 6 monthes |
Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics

Study Overview
=================
Brief Summary
-----------------
This study compares synthetic mammography to full-field digital mammography in image interpretation and performance metrics. Digital breast tomosynthesis (DBT) has previously been found to be superior in performance to standard digital mammography in both screening and diagnostic settings for the early detection and improved diagnosis of breast cancers. DBT in combination with full-field digital mammography (FFDM) reduces recall rates and increases cancer detection rates relative to FFDM alone. Synthetic mammography is a 2-dimensional reconstructed image, using the dataset derived from the DBT acquisition, without requiring additional radiation dose. Collecting information from patients' medical records may help doctors analyze the characteristics, utility, and impact of synthetic mammography to compared to FFDM.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To analyze the characteristics, utility, and impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM). OUTLINE: Patients' medical records and past imaging examinations are reviewed.

Official Title
-----------------
Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Other: Electronic Health Record Review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18 or older Consecutive cases in breast imaging center Exclusion Criteria: Cases demonstrate administrative or technical errors (e.g. missing views, labeling inconsistent with report, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Observational (medical records)<br>Patients' medical records and past imaging examinations are reviewed. | Other: Electronic Health Record Review<br>* Review of medical records and past imaging examinations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM |  | through study completion, an average of 1 year |
Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the diagnostic yield with endoscopic mucosal resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase staining. Additionally, the proportion of patients who would have required subsequent full thickness surgical biopsy with each technique will be compared. Biopsy results will be compared with clinical data including history, Bristol stool scale, anorectal manometry results and SITZ markers studies. Finally, the estimated costs that would have been incurred with each method will be evaluated.

Official Title
-----------------
Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial

Conditions
-----------------
Chronic Constipation, Hirschsprung's Disease

Intervention / Treatment
-----------------
* Procedure: Endoscopic Mucosal Resection (EMR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients offered a rectal suction biopsy Exclusion Criteria: any contraindication to general anesthesia or conscious sedation contraindication to endoscopy untreated or unmanageable coaguloapathy thrombocytopenia (<50) inability to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic Mucosal Resection (EMR)|EMR is a common procedure in gastroenterology. The technique involves placing a band around a piece of mucosa in the GI tract. The band and the tissue are then removed using a cautery snare. The technique can be used to obtain tissue for diagnostic purposes or to remove lesions for therapeutic purposes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The major goal of this study is to test the hypothesis that EMR will result in a higher proportion of diagnostic specimens than RSB in patients sent for rectal suction biopsy. |  | April 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome variables include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain. |  | April 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hirschsprung's disease, Constipation, Endoscopy, digestive system, Diagnosis, Colonoscopy
Prospective Evaluation of Treatment for Clubfoot

Study Overview
=================
Brief Summary
-----------------
Specific aim: To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions

Detailed Description
-----------------
PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol for the collection of relevant clinical and functional outcome measures on our patients with a diagnosis of clubfoot.

Official Title
-----------------
Prospective Evaluation of Treatment for Clubfoot

Conditions
-----------------
Clubfoot Deformity

Intervention / Treatment
-----------------
* Procedure: Surgical
* Procedure: Non-Surgical
* Procedure: Non-surgical + surgical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of clubfoot deformity Spanish speaking patients will be eligible to participate in the study. Exclusion Criteria: All patients without a diagnosis of clubfoot

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Surgical<br>Corrective Surgery only | Procedure: Surgical<br>* Surgery only<br>|
| Non-Surgical<br>Correction with casting, braces, Physical therapy, other non-surgical methods | Procedure: Non-Surgical<br>* non-surgical methods such as, casting, bracing, physical therapy, and other.<br>|
| Non-surgical + surgical<br>Correction with casting, braces, Physical therapy, other non-surgical methods subsequently followed by Corrective Surgery | Procedure: Non-surgical + surgical<br>* Combination of non-surgical methods subsequently followed by surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of correction at initial brace wear | Dimeglio scoring system will be used (score range from 0-20) | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clubfoot, deformity, correction, management, gait
I-Gel in Out-of-hospital Cardiac Arrest in Norway

Study Overview
=================
Brief Summary
-----------------
The main objective of this trial is to compare the effectiveness of a newer supraglottic airway method (the i-Gel), compared to current airway management practice in out-of-hospital cardiac arrests treated by Norwegian ambulance services.

Official Title
-----------------
I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial

Conditions
-----------------
Out of Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Device: I-Gel
* Device: LTS, ETI or current airway management practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-of-hospital cardiac arrest patients requiring and receiving advanced airway management on ambulance missions. Advanced airway management is defined as the attempted insertion of an airway adjunct (I-Gel, laryngeal tube or ETI) or the administration of ventilatory assistance/support (including bag-mask ventilation (BMV) or other ventilatory support. Adult patients (> 18 years). Exclusion Criteria: Non-adult patients / minors (< 18 years). Traumatic cardiac arrest.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I-Gel<br>I-Gel supraglottic airway device | Device: I-Gel<br>* I-Gel supraglottic airway device<br>|
| Active Comparator: LTS, ETI or other airway practice<br>Laryngeal tube, endotracheal tube or other current airway management practice | Device: LTS, ETI or current airway management practice<br>* Laryngeal tube, endotracheal tube, bag-mask-ventilation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilation success | ventilation success defined as successful insertion of device with visible chest movement with each ventilation, audible air passage on auscultation, and ETCO2 confirmation (if available) of tube placement | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival to hospital discharge / 30-day survival |  | up to 30 days | 
| levels of ETCO2 related to the presence and quality of bystander CPR |  | up to 24 hours | 
| cerebral function assessed by Glascow Outcome Score at discharge from hospital |  | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | 
| insertion related complications |  | up to 24 hours |
Long Term Safety Of GW685698X Via Nasal Biopsy

Study Overview
=================
Brief Summary
-----------------
Long term safety (52 weeks) of GW685698X on the nasal mucosa via nasal biopsy with an active control group (Nasonex®) and a healthy volunteers control group in subjects 18 years old with perennial allergic rhinitis . Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial allergic rhinitis is triggered by house dust mites, animal dander, etc., possibly causing symptoms year-round including nasal congestion, rhinorrhea and/or nasal itching.

Detailed Description
-----------------
A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via Nasal Biopsy in Subjects >18 Years of Age with Perennial Allergic Rhinitis (PAR)

Official Title
-----------------
A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD Via Nasal Biopsy in Subjects 18 Years of Age With Perennial Allergic Rhinitis (PAR)

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: GW685698X
* Drug: mometasone furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen. Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control. Exclusion criteria: Patients who require certain medications for their allergy. Patients with serious medical problems.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: GW685698X<br> <br> Drug: mometasone furoate<br> <br> * Other names: GW685698X;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative and qualitative differences in the morphology and cytology of the nasal mucosa after 1 year of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No Secondary Outcome Measures |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perennial allergic rhinitis, nasal biopsy, GW685698X
A Retrospective Review of Infections Usually Observed in Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The study will identify patients with infections commonly observed in transplant recipients, describe the epidemiology of their infection, study the risk factors associated with various infections and examine strategies of early diagnosis and prevention of infection

Detailed Description
-----------------
The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, previous medical surgical conditions, microbiology and virology culture results, laboratory and radiographical data, antimicrobial usage of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, pathology and histology results, summaries of admissions, discharges, operations, death, medications, clinical outcome gender, height, weight, ethnicity, date of transplant, type of transplant, primary diagnosis, and past medical history. Also required are medical summaries of admissions, discharges, operations, and deaths

Official Title
-----------------
A Retrospective Review of Infections Usually Observed in Transplant Recipients

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who receive medical care at UPMC Patients who developed infections usually observed in transplant recipients Exclusion: Patients who do not receive medical care in UPMC Oakland campus
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
-----------------
Infection, transplant recipients
A Multiple Ascending Dose Study of R1530 in Patients With Advanced Solid Tumors.

Study Overview
=================
Brief Summary
-----------------
This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Official Title
-----------------
An Open-label, Multiple Ascending Dose Study to Determine the Maximum Tolerated Dose of R1530 in Patients With Advanced Solid Tumors.

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: RG1530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; cancer not amenable to curative treatment (ie advanced and/or metastatic); measurable or evaluable disease; adequate cardiac, hepatic and renal function. Exclusion Criteria: patients with known CNS metastases; serious cardiovascular illness or other medical conditions; prior chemotherapy, radiotherapy or immunotherapy within 28 days of start of treatment , or hormone therapy within 14 days of start of treatment; inability to swallow oral medications, or impaired gastrointestinal absorption.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RG1530<br>* Administered po at escalating doses (10 cohorts)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs, laboratory parameters |  | Throughout study | 
| Plasma levels of R1530 |  | Throughout study | 
| Tumor assessments |  | Every 2 cycles of treatment |