linjc16/ctgov huggingface dataset:
Peri-operative Risk Factors for Postoperative Pressure Ulcer in Surgical Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to overall evaluate and validate preoperative and intra-operative risk factors for postoperative pressure ulcers in critically ill postoperative patients.

Conditions
-----------------
Postoperative Pressure Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in ICU with a greater than 48 hours Underwent a surgical procedures, Absence of pressure ulcer present at admission to the ICU and developed a stage II or higher pressure ulcer, deep tissue injury, or unstageable ulcer, as defined by the pressure ulcer staging guidelines of the National Pressure Ulcer Advisory Panel. Exclusion Criteria: Patients will be excluded from the study if they had been diagnosed with pressure ulcer before the surgery Pediatric patients

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 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 |
| --- | --- |
| pressure ulcer group<br>Patient who developing pressure ulcer categorized as stage more than II after surgery | |
| Control group<br>Patients has identical values on the matching factors such as age, sex and surgical procedures of control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| independent preoperative risk factors | Postoperative new-onset pressure ulcers were identified from nursing documentation in the patient's electrical medical record within 1 month after surgery | up to1 month after surgery |
Glycemic Control Of Carvedilol Versus Metoprolol In Patients With Type II Diabetes Mellitus And Hypertension

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of two different antihypertensive medications in the drug class of beta-blockers on control of glucose in Type II diabetic patients with high blood pressure.

Official Title
-----------------
A Randomized, Double-Blind, Multicenter Study Comparing the Glycemic Control Characteristics of Carvedilol and Metoprolol in Hypertensive Patients With Type II Diabetes Mellitus.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: carvedilol
* Drug: metoprolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients at screening must be insulin producing Type II diabetics (C peptide positive). Must have a history of mild to moderate hypertension (140-179 systolic; 90-1-9 diastolic). Must be on stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments. Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone). Must be on a stable antidiabetic regimen (drug treated or diet alone). Exclusion criteria: Patients using beta-blocker therapy.

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carvedilol|nan|
|Drug: metoprolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 5 months |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure at 3 and 5 months. Body weight at 3 and 5 months. Lab values (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months. |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, hypertension, beta-blockers
Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.

Official Title
-----------------
Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary

Conditions
-----------------
Diabetes Mellitus, Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has Type 1 or Type 2 diabetes mellitus Subject is 18 to 70 years old Subject has chronic, active symptoms of gastroparesis for at least the past three months Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule Subject can speak and read English Subject is able to give his/her informed consent Exclusion Criteria: 1. Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit -

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br>Adult subjects with diabetes mellitus and a diagnosis of gastroparesis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative, Content Analysis of Cognitive Debriefing Data | The cognitive debriefing data will be content analyzed for patient understanding of the concepts in the questionnaire and interpretation of the items' content. | 90-minute interview | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Debriefing
Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
Esophageal cancer is a highly aggressive malignancy with a poor overall outcome. Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases. No standard postoperative adjuvant chemotherapy has ever been established.

Official Title
-----------------
Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: paclitaxel; cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to give informed consent histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins node-positive and pathologic stage M0 . Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patients were enrolled 4 to 10 weeks after surgery. Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits. Exclusion Criteria: prior chemotherapy or concurrent radiation therapy before esophagectomy R1 or R2 resection clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination

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: single arm paclitaxel and cisplatin<br> | Drug: paclitaxel; cisplatin<br>* The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.<br>* Other names: Paclitaxel Injection, Beijing Union Pharmaceutical Factory;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year overall survival |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 year disease-free survival |  | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal cancer, adjuvant chemotherapy, esophageal surgery, paclitaxel, cisplatin
Patient Recall After Orthopedic Trauma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether receiving education after trauma surgeries affects three things: 1) knowledge about injury and treatment (recall), 2) how well patients follow treatment recommendations, and 3) how satisfied patients are with their care. To do so, some participants in this study will receive education, and some will not.

Official Title
-----------------
Validating a Teach-back Protocol to Improve Recall in Orthopedic Trauma Patients

Conditions
-----------------
Education After Trauma

Intervention / Treatment
-----------------
* Behavioral: Educational Teach Back


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Isolated open or closed fracture of the pelvis and/or lower extremity treated surgically Exclusion Criteria: Patient receiving orthopedic care or follow-up at another institution Non-English speaking Incarcerated (or likely impending incarceration) Currently enrolled in a study that does not permit co-enrollment Traumatic brain injury, dementia, or other cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postoperative teach-back educational program<br>Patients will receive teach-back education while they fill out questionnaires. | Behavioral: Educational Teach Back<br>* Patients will receive teach-back education while they fill out questionnaires.<br>|
| No Intervention: Control<br>Patients will not receive any teach-back education while filling out questionnaires. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of correct answers to the recall-assessing items on the follow-up questionnaire. |  | Up to 45 minutes | 
| Adherence rate to postoperative weightbearing instructions as measured by patient report. |  | Up to 180 days post op | 
| Adherence rate to DVT prophylaxis instructions as measured by patient report. |  | Up to 180 days post op | 
| Mean satisfaction as measured by follow-up questionnaire. | Satisfaction will be measured on a Likert scale from 1-5 with 1 being very dissatisfied and 5 being very satisfied with care | Up to 180 days post op |
A Study to Determine if Mesh Placement During Bladder Surgery Can Reduce the Chances of Developing a Hernia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.

Official Title
-----------------
A Prospective, Randomized Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia

Conditions
-----------------
Radical Cystectomy

Intervention / Treatment
-----------------
* Procedure: Surgery Radical Cystectomy
* Procedure: Ultrapro mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing RC and IC formation in an elective setting,for cancer. Exclusion Criteria: Expected survival < 12 months Salvage RC Distant metastatic disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery (Usual approach group)<br>standard surgery | Procedure: Surgery Radical Cystectomy<br>* All surgeries will be performed in an open or laparoscopic fashion.<br>|
| Experimental: Surgery + Mesh Placement<br>prophylactic mesh at the time of standard surgery | Procedure: Surgery Radical Cystectomy<br>* All surgeries will be performed in an open or laparoscopic fashion.<br>Procedure: Ultrapro mesh<br>* Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with incidence of radiographic Parastomal Hernia |  | within 2 years of RC and IC. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mesh Placement, Radical Cystectomy, 16-1285
Predictors of Poor Outcomes in 1038 Sigma Knees

Study Overview
=================
Brief Summary
-----------------
The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.

Detailed Description
-----------------
It is known that surgical outcomes are good in the majority following a Sigma knee at 5 years. 3% have persistent pain. Is it possible to predict these patients? Is it possible to make a determination as to which of the 3 outcome measures ((1) American Knee Society Score; (2) SF12 Oxford 12 and (3) Complications) is most appropriate to use and when is the most appropriate time to use it

Official Title
-----------------
Predictors of Poor Outcomes in 1038 Sigma Knees

Conditions
-----------------
Total Knee Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing total knee replacement in Fife
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 |
| --- | --- | --- |
| Predictors of poor outcomes using 3 measures | A prospective database was set up in October 1998. Patient details were collected preoperatively, intra operatively and immediately post operatively. Patients are then followed up in a dedicated knee clinic at 6 months, 18 months, 3 years and 5 years. Data such as SF12 and the American Knee Society Score was done at each visit | 10 years |
The Comparative Study About the Effect of Vertebral Body Decompression Procedure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design

Official Title
-----------------
The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study

Conditions
-----------------
Osteoporotic Vertebral Compression Fracture

Intervention / Treatment
-----------------
* Procedure: Decompression
* Procedure: Conservative Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoporotic vertebral compression fracture Exclusion Criteria: malignancy or inflammatory disease severe pain in other joints coagulopathy an inappropriate person considered by investigator

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: Decompression<br>bone marrow decompression at fractured vertebral body | Procedure: Decompression<br>* vertebral body decompression in compression fracture<br>|
| Active Comparator: Conservative Treatment<br>Conservative Treatment for compression fracture | Procedure: Conservative Treatment<br>* Conservative Treatment in vertebral compression fracture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | Pain status | until 3 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | Health status | until 3 months after procedure | 
| EQ5D-5L | Quality of Life | until 3 months after procedure | 
| Leed Dyspepsia Questionnaire | Abdominal discomfort d/t medication and injection | until 3 months after procedure | 
| Radiographic outcome | Compression rate | until 3 months after procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vertebroplasty, Core decompression, Osteoporosis
Growth Curves in Cockayne Syndrome Type 1 and Type 2

Study Overview
=================
Brief Summary
-----------------
Despite the natural progression of Cockayne's syndrome, affected patients also present with variable neurological and gastrointestinal damage (gastroesophageal reflux, recurrent vomiting, swallowing disorders, etc.) with varying repercussions on their growth. Acute intercurrent events such as seizures, constipation, infections can also interact with their metabolism, food intake and influence their growth. The nutritional deficit potentially involved in this growth retardation can be responsible for many manifestations such as anemia, bone fractures, fatigue, coagulation disorders responsible in total for the reduction in quality and life expectancy. Faced with growth retardation in patients with Cockayne syndrome, medical management is difficult to establish. Is this delay part of the natural course of the pathology?

Official Title
-----------------
Development of Growth Curves in Cockayne Syndrome Type 1 and Type 2

Conditions
-----------------
Cockayne Syndrome, Type I and II

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Minor patient Cockayne syndrome with molecular confirmation, treated between 01/01/1985 and 01/03/2020 Collection of at least one growth data (height, weight, head circumference) for a given age Clinic compatible with type 1 or 2 Cockayne syndrome Holder of parental authority not opposing, after information, the reuse of their child's medical data for the purposes of this scientific research. Exclusion criteria: Refusal to participate in the study. Lack of molecular confirmation of Cockayne syndrome Lack of growth data for a given age. Clinic not compatible with type 1 or 2 Cockayne syndrome. Exclusion of type 3 Cockayne syndromes, trichothiodystrophy and xeroderma-pigmentosum.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- | --- |
| Development of growth curves in Cockayne syndrome type 1 and type 2 from existing medical data |  | Files analysed retrospectively from January 01, 1985 to March 01, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cockayne Syndrome, Cockayne Syndrome, Type I and II, Growth curves