linjc16/ctgov huggingface dataset:
Recurrence Risk Evaluation by 21-gene Detection

Study Overview
=================
Brief Summary
-----------------
Breast cancer patients with early breast cancer were enrolled according to the inclusion criteria. Baseline characteristics were recorded from medical record system. Recurrence score were obtained by 21-gene detection kits from different biological companies. Relationship between recurrence score and the prognosis was explored. Meanwhile, the investigators analyzed the consistency of the results obtained from various 21-gene test kits and immunohistochemistry detection.

Official Title
-----------------
Postoperative Recurrence Risk Evaluation of Hormone Receptor Positive, Her-2 Negative Breast Cancer by Using Different 21-gene Detection Kits (REBCK)

Conditions
-----------------
Relationship and Consistency Analysis

Intervention / Treatment
-----------------
* Diagnostic Test: recurrence risk evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer in stage I-III, tumor size>0.5cm lymph nodes negative hormone receptor positive （ER+/PR+,ER+/PR-,ER-/PR+） HER2 negative（IHC 0 or +， FISH negative） receive endocrine therapy only enough FFPE samples within 10 years（3 6 10μm ） patients with integrated medical records Exclusion Criteria: Tumor cells <5% Isolated RNA<500ng

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: recurrence risk evaluation|Recurrence score were obtained by 21-gene detection kits from different biological companies. The expression of ER, PR, and Her-2 were also detected by IHC.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation analysis | x2 value and P value of chi-square test | Janyary 1, 2019-December 31, 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consistency analysis | kappa value, P value of consistency analysis | Janyary 1, 2019-December 31, 2019 |
A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.

Official Title
-----------------
MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: MK0906, finasteride / Duration of Treatment: 48 weeks
* Drug: Comparator: placebo / Duration of Treatment: 48 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with benign prostatic hyperplasia Exclusion Criteria: Patients who are suspected to be suffering from prostatic cancer

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
Male

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

| Intervention/Treatment |
| --- |
|Drug: MK0906, finasteride / Duration of Treatment: 48 weeks|nan|
|Drug: Comparator: placebo / Duration of Treatment: 48 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the International Prostate Symptom Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in QOL - index |  |  | 
| Change from baseline in maximum urinary flow rate, % |  |  | 
| Change from baseline in Prostate volume |  |  |
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

Detailed Description
-----------------
A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.

Official Title
-----------------
A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion

Conditions
-----------------
Newly Diagnosed Supratentorial Malignant Glioma

Intervention / Treatment
-----------------
* Drug: Gliadel Wafer
* Drug: Temozolomide
* Procedure: Limited field radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MRI showing unilateral supratentorial cerebral tumor surgical tx within 4 weeks of baseline MRI KPS 60% or higher moderate to high grade malignant glioma Exclusion Criteria: prior cytoreductive surgery for moderate or high grade glioma prior CNS radiotherapy prior chemo for this glioma more than one focus of tumor or tumor crossing the midline per MRI life expectancy less than 12 months sensitivity to temozolomide, nitrosoureas, or Gliadel wafer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 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: Gliadel Wafer|nan|
|Drug: Temozolomide|nan|
|Procedure: Limited field radiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and efficacy of Gliadel 3.85% wafers |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma, Gliadel Wafer
Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
A prospective, randomized study will be performed. Patients are randomized using a 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). The primary outcomes variable will be occurrence of incisional SSI. Follow-up will be 30 days postoperatively.

Detailed Description
-----------------
A prospective, randomized study will be performed. Patients are randomized using a random number table into 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). In group 1 the wound will be covered with a Vitamin E embebbed gauze and plastic adhesive tape. In Group 2, , the wound will be covered with standard gauze and plastic adhesive tape. The primary outcomes variable will be occurrence of incisional SSI, defined by CDC criteria. Follow-up will be 30 days postoperatively.

Official Title
-----------------
Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery

Conditions
-----------------
Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Vitamin E
* Drug: Standard dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of colorectal neoplasms plan to undergo an elective operation with curative aims laparoscopic surgery Exclusion Criteria: Anastomotic leak Lost to 30-days follow-up
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Experimental: Vitamin E dressing<br>Patients will receive a Vitamin E-containing dressing over the wound | Drug: Vitamin E<br>* The applied dressing will be embebbed in Vitamin E<br>* Other names: Exerimental group;|
| Sham Comparator: Standard dressing<br>Patients will receive a standard dressing over the wound | Drug: Standard dressing<br>* The applied dressing is a normal one without adding any product to it.<br>* Other names: Control group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional surgical site infection | Patients present a wound with the CDC criteria for SSI | 30 days postoperatively |
Evaluation of Coaching Impact on Surgical Outcomes

Study Overview
=================
Brief Summary
-----------------
This two arms parallel cluster-randomized trial will evaluate the impact of a customized coaching program for surgeons on the occurrence of patient major adverse events. Trends in surgical outcomes before and after the intervention will be compared between surgeons randomly assigned to the coaching program against non-exposed surgeons.

Official Title
-----------------
Understanding the Influence of Human and Organizational Factors on Surgeon Performance to Enhance Patient Outcomes: Experimental Evaluation of a Customized Coaching Program

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Behavioral: Coaching program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults needing a surgery who are operated by one of the participating surgeons Exclusion Criteria: Age < 18 years old Absence of surgical procedure Palliative care Organ transplantation Refusal for personal data sharing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Surgeons randomly assigned to the intervention arm | Behavioral: Coaching program<br>* Charting system for outcomes feedback Profiling of individual surgeon Modules of improvement<br>|
| No Intervention: Control arm<br>Surgeons randomly assigned to the control arm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of major adverse event |  | During surgery or within 30 days after the operation | 
| Occurrence of death |  | During surgery or within 30 days after the operation | 
| Occurrence of unplanned stay in critical/intensive care unit |  | Within 30 days after the operation | 
| Occurrence of unplanned reoperation |  | Within 30 days after the operation | 
| Occurrence of intraoperative and postoperative complications |  | During surgery or within 30 days after the operation | 
| : Occurrence of avoidable hospital readmission for complication |  | Within 30 days after the operation | 
| Operative time |  | From skin incision to wound closure | 
| Length of stay |  | From hospital admission to discharge, within 30 days after operation | 
| Hospitalization costs |  | Within 30 days after the operation | 
| Surgeon well-being |  | Throughout the study, Through study completion, an average of 1 year |
Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi FinTerveys Study

Study Overview
=================
Brief Summary
-----------------
P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). The hypothesis of the study is that 1) combining genetic and metabolic risk with traditional risk factors adds value to the personal risk assessment of these diseases, 2) such risk information can be provided to individuals using a web based user portal in an easily understandable and useful format, and 3) receiving genetic and metabolomic risk information has an effect on the health of the study participants. The study is a continuation of FinHealth 2017 -study, which involved more than 7,000 Finns from around the country. The participants of FinHealth were invited to participate in P5.fi -study. The new research utilises information, samples, and measurements obtained in the FinHealth Study. Prospective clinical significance of selected genetic and metabolomic risk scores will be studied in 30.000 Finnish individuals. The study will analyze the genetic and metabolomic profile of the P5.fi participants and develop and test a protocol for returning them health related risk information. The impact of the intervention will by followed up by questionnaires and national health registers for five years.

Official Title
-----------------
Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi

Conditions
-----------------
Coronary Heart Disease, Type 2 Diabetes, Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Only participants of FinHealth 2017 -study are eligible for the study Exclusion Criteria: - Participants not part of FinHealth 2017 -study are not eligible
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary heart disease/Type 2 diabetes/Venous thromboembolism diagnosis | Disease diagnosis observed from the national hospitalization and death registries. | Measure is assessed after a year from the start of the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genetic risk score, metabolic risk score, health promotion, web-based, intervention
Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation

Study Overview
=================
Brief Summary
-----------------
This is a retrospective review of the COLTT program outcomes and factors that predict recovery of functional status after lung transplantation.

Detailed Description
-----------------
The Center of Life for Thoracic Transplant (COLTT) program is a daily (5 days per week) intensive rehabilitation program for patients who have undergone lung transplant. Patients are enrolled in COLTT as part of standard care after hospital discharge. This study is a retrospective review of seventy patients that measures the efficacy of the COLTT program and establishes predictors of patient success.This study will also measure the effect of functional outcomes on hospital readmission post COLTT discharge.

Official Title
-----------------
Factors Predicting Success in Lung Transplant Recipients Who Have Participated in the COLTT Program (Daily Intensive Post-hospitalization Rehabilitation): A Retrospective Review

Conditions
-----------------
Lung Transplant

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who completed the COLTT program from May, 2016 to July, 2017. Exclusion Criteria: Any COLTT patients who were not new lung transplant recipients.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Exercise|5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach program goals (days) | The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures) | Through study completion, an average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed (mph, % expected) | Gait speed (walking speed) is measured daily on a oval track | Through study completion, an average of 4 weeks | 
| Single leg stance performance (seconds, % expected) | The test result of a single leg stance test. Patients stand with hands on their hips, raise one leg off the ground and hold it for as long as possible. | Through study completion, an average of 4 weeks | 
| One-minute sit to stand performance (number, % expected) | The test result of a one-minute sit to stand test. Patients stand/sit from a chair as many times as they can in one minute. | Through study completion, an average of 4 weeks | 
| Six minute walk distance (feet, % expected) | The test result of a six-minute walk test, a field test of exercise capacity | Through study completion, an average of 4 weeks |
Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review patients with E. coli infections at UPMC from September 1, 2008 to August 31, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes and determine their clinical outcomes. The specific aims of this study are to: Review whether cephalosporin-resistant E. coli infections are hospital-acquired, healthcare-associated or community-associated. Determine the clinical outcome of the patients according to the antibiotics given.

Detailed Description
-----------------
De-identified data will be obtained by the honest broker for the requested time period. In addtion, the honest broker will work with the microbiology laboratory to collect the isolates associated with the de-identified data. All data and samples will be de-identified. De-identified data will be given to the nurse coordinator to complete the case report forms and enter the data into the password protected database and the de-identified isolates will be stored and analyzed on the 8th floor Scaife in Dr. Yohie Doi's laboratory.

Official Title
-----------------
Clinical and Microbiologic Characteristics of Cephalosporin-Resistant E. Coli-PITT Protocol

Conditions
-----------------
E Coli Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with E. coli infections at UPMC Exclusion Criteria: not meeting entry criteria

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

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 |
| --- | --- | --- |
| dead or alive | health status | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
E. Coli, isolates
A Study of 18F-AV-45 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will determine how florbetapir F 18 (18F-AV-45) radioactivity is distributed throughout the body.

Official Title
-----------------
Positron Emission Tomography Whole Body Biodistribution Using 18F-AV-45

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: florbetapir F 18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to lie still on the imaging table for periods up to 1 hour Exclusion Criteria: Radiation exposure for experimental purposes within the last year Claustrophobic or otherwise unable to tolerate the imaging procedure Medical condition or surgical history that would confound evaluation Current clinically significant cardiovascular disease Received an investigational medication within the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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 |
| --- | --- |
| Experimental: Healthy Volunteers<br>Healthy male or female subjects, between 18 and 85 years of age. | Drug: florbetapir F 18<br>* IV injection, 370MBq (10mCi), single dose<br>* Other names: florbetapir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Body Radiation Dosimetry | Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body. | 0-380 min after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging