linjc16/ctgov huggingface dataset:
Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.

Official Title
-----------------
Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Procedure: tourniquet
* Procedure: no tourniquet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis og osteoarthritis of the knee patients must be 18 years or older patients must understand and speak danish must be able to give signed consent Exclusion Criteria: severe medical illness documented osteoporosis rheumatoid arthritis prior surgery in the knee neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: with tourniquet<br> | Procedure: tourniquet<br>* a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment<br>|
| Placebo Comparator: without tourniquet<br> | Procedure: no tourniquet<br>* a tourniquet around the thigh is not used during insertion of the TKA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| migration of the prosthesis in millimeters assessed vith RSA. | does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis? | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain. | Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion | 2 years | 
| Patient satisfaction (VAS-scale) | Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion | 2 years | 
| Knee range of motion (degrees) | Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TKA, RSA, Tourniquet, Arthroplasty, Knee
How Respiratory Pathogens Panel Results Affect Patients' Plan of Care

Study Overview
=================
Brief Summary
-----------------
Reviewing providers' current standard operating procedure on Respiratory Pathogen testing

Detailed Description
-----------------
The general design of this study is collecting data and reviewing Principal Investigators' Standard Operating Procedures on Respiratory Pathogen testing and changes made to their specific SOP.

Official Title
-----------------
Medical Provider Assessment On Healthcare Decisions Post-Testing of Respiratory Pathogens (RP Panel) Along With Risk Reducing, and Preventative Strategies

Conditions
-----------------
Respiratory Disease

Intervention / Treatment
-----------------
* Other: respiratory pathogen panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a Medical Practitioner Medical Doctor (MD) Doctor of Osteopathic (DO) Physician Assistant (PA) Advanced Practice Registered Nurse (APRN) Nurse Practioner (NP) Must have a current standard operating procedure that includes obtaining/reviewing medical history. Exclusion Criteria: Government-funded insurance data cannot be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: respiratory pathogen panel|lab testing for respiratory pathogens|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Structures and Processes | Plan of Care Changes due to Respiratory Pathogen testing. Provider based observational survey system on the health and well-being of patients and populations | 36 months |
Living Donation and Kidney Transplantation Information

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to increase awareness and knowledge regarding the risks and benefits of kidney transplantation and living donation amongst patients seeking kidney transplantation and their family and friends in Buffalo, New York.

Detailed Description
-----------------
This prospective randomized parallel controlled trial of kidney transplant candidates receiving and educational intervention and standard of care education versus standard of care education only to improve informed decision making about kidney offers.

Official Title
-----------------
Living Donation and Kidney Transplantation Information Made Easy (KIDNEYTIME) With Animated Video Education

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Other: Educational Video Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be 18 years or older, understand and read English (or have a support person that helps them) have acceptable vision to watch videos be able to give consent Exclusion Criteria: incarcerated involved in the former modeling phase of animation development.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Video<br>Participants were exposed to 2 educational videos in addition to standard of care education. | Other: Educational Video Intervention<br>* Educational videos<br>|
| No Intervention: Standard of Care<br>Participants received standard of care education. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge | Assessed by knowledge survey pre and post exposure. | Baseline and immediately post exposure | 
| Change in attitude about kidney offers | Assessed by attitude survey pre and post exposure. | Baseline and immediately post exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective decisional self-efficacy | Assessed by self-efficacy survey pre and post exposure. | Baseline and immediately post exposure | 
| Participation and decision making | Number of questions and value statements in regards to organ offers. | 1 day (During standard of care education at time of clinic visit) |
Obesity's Impact on the Effect of Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether there is a correlation between hip arthroplasty patients' preoperative weight and the patients quality of life and the clinical effect one year postoperatively.

Official Title
-----------------
Obesity's Impact on the Clinical Efficacy and Quality of Life 1 Year After Primary Total Hip Arthroplasty

Conditions
-----------------
Hip Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients recommended for primary total . Exclusion Criteria: Rheumatoid arthritis.

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 |
| --- | --- |
| Hip Osteoarthritis<br> | Procedure: Hip arthroplasty<br>* The purpose of hip arthroplasties is to reduce pain and increase mobility.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | A patient reported outcome (PRO). The questionnaire is a tool for measuring health status. The form is used to measure the patient's view of his own health by scoring standardized responses to standardized questions. The schedule consists of 36 questions representing eight health concepts. | Measured 1 week before surgery and 12 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOOS | Hip - specific patient-reported outcome that measures the patient's own assessment of hip problems and related problems. The schedule consists of 42 questions representing 5 strands. | Measured 1 week before surgery and 12 months postoperatively | 
| Body composition | Dual energy X-ray absorptiometry (DEXA) can measure total body bone mineral density and obtain accurate measurements of body tissue composition (muscle mass and fat mass). By measuring the body's muscle mass, fat mass and bone mineral density, one can estimate total body fat percentage. | Measured 1 week before surgery and 12 months postoperatively | 
| Bone mineral density (BMD). | Measured by DXA scan. | Measured 1 week before surgery and 12 months postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, obesity, quality of life
Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the prevalence of anemia and iron deficiency in pregnancy through a multi-center, prospective follow-up study . To explore the influence factors of anemia and iron deficiency in pregnancy; to explore the influence of anemia and iron deficiency in pregnancy on maternal and fetal outcomes.

Detailed Description
-----------------
To understand the epidemiological characteristics of anemia and iron deficiency in pregnancy and describe the epidemiological situation of anemia and iron deficiency. To explore the influence factors of anemia and iron deficiency in pregnancy. To explore the influence of anemia and iron deficiency during pregnancy on the pregnancy outcome of mothers and infants.

Official Title
-----------------
Epidemiological Study on Anemia and Iron Deficiency in Pregnancy in Medical Institutions in Some Areas of China

Conditions
-----------------
Prevalence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular prenatal check-ups were conducted in the hospitals participating in the study, and pregnant women who planned to give birth in hospital were established a maternity health manual 18 years and older Patients have to agree to participate by signing a consent Exclusion Criteria: have severe chronic diseases with Pre-pregnancy Suffer from severe mental illness

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb | Proportion of patients with Hb<110g/L | Completed by observation，an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF | Proportion of patients with SF<20μg/L | Completed by observation，an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency, Anemia during pregnancy
A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

Study Overview
=================
Brief Summary
-----------------
The study is to understand whether distribution of two different supplies of nicotine patches through a telephone quitline has an effect on quit rates. The two different supplies are four vs. eight (in two separate four-week mailings) weeks of nicotine patches. The hypothesis is that eight weeks will be slightly more efficacious but four weeks will be more cost-effective.

Official Title
-----------------
A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: Nicotine Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All callers to the Colorado QuitLine who report currently smoking 16-20 cigarettes who enroll in QuitLine services who do not require physician approval to obtain nicotine replacement therapy who are willing to receive the nicotine patch Exclusion Criteria: Contraindications to receiving the nicotine patch through the QuitLine without physician approval include: history of hearth disease (heart attack, chest pain, or coronary artery disease), high blood pressure, pregnancy, skin conditions such as difficult to manage psoriasis or eczema, or history of a local reaction to the nicotine patch those who do not complete the call in English

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Patch (4 weeks)<br>participants receive one 4-weeks supply of nicotine patches | Drug: Nicotine Patch<br>* nicoderm patches are distributed in two different supplies through a telephone quitline<br>* Other names: Nicoderm Committed Quit patches;|
| Experimental: Nicotine Patch (8 weeks)<br>participants receive up to 8 weeks of nicotine patches in up to two 4-week supplies | Drug: Nicotine Patch<br>* nicoderm patches are distributed in two different supplies through a telephone quitline<br>* Other names: Nicoderm Committed Quit patches;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day smoking abstinence |  | 7 days | 
| 6-month smoking abstinence |  | 6 months | 
| cost-effectiveness | cost per quit of each study arm will be calculated based on the total costs of the intervention from actual utilization data (nicotine patch costs + counseling call costs) and quit rates | 6 months |
Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fed conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

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

Intervention / Treatment
-----------------
* Drug: Ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Ramipril or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ramipril|10 mg capsule|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, two-period, 7 day washout |
CtDNA After Chemotherapy in Elderly Patients With Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
This study will monitor CtDNA After Chemotherapy in Elderly Patients With AL

Detailed Description
-----------------
This study will use droplet digital PCR (ddPCR) method to quantify peripheral blood plasma mutant allele frequency (MAF) in elderly acute leukemia patients after chemotherapy to evaluate the clinical value of CtDNA .

Official Title
-----------------
Monitoring Circulating Tumor DNA After Chemotherapy in Elderly Patients With Acute Leukemia

Conditions
-----------------
Acute Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Male not pregnant female patients >=60 years old Diagnosis of acute leukemia Exclusion Criteria: Pregnancy HIV positive patients >=100 years old

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| cumulative incidence of relapse(CIR) | cumulative incidence of relapse | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | overall survival | through study completion, an average of 2 years |
The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

Study Overview
=================
Brief Summary
-----------------
To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.

Detailed Description
-----------------
Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation. Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib. Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Official Title
-----------------
The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

Conditions
-----------------
Non-Small-Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NSCLC based on histopathologic examination Adenocarcinoma and/or nonadenocarcinoma based on histology examination Clinical stadium stage IIIB and IV Age 16-70 years old Received gefitinib as therapy At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015 Exclusion Criteria: Missing data of any variables of the treatment outcomes in the medical record

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| PFS (Progression Free Survival) | Progression Free Survival (PFS) as defined by RECIST 1.1 or attending physician's clinical judgement of clinical progression state | through study completion, in average of 1 year | 
| Overall Survival (OS) | Overall Survival (OS) as defined by the date of death certificate given by the attending physician or by other government officials | through study completion, in average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenocarcinoma, non-adenocarcinoma
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.

Study Overview
=================
Brief Summary
-----------------
Demonstrate that the use of benchmarking improves quality of patient care, in particular the control of diabetes, lipids and blood pressure, by determining the percentage of patients in the benchmarking group achieving pre-set targets for HbA1c 14,18, LDL-cholesterol16,18 and Systolic Blood Pressure17,18 versus control group (non-benchmarking group) after 12 months of follow-up.

Official Title
-----------------
OPtimal Type 2 dIabetes Management Including Benchmarking and Standard trEatment.

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed Consent Patients suffering from diabetes type II, insulin dependent or not insulin dependent. Exclusion Criteria: Type I diabetes Pregnancy diabetes Hospitalisation, as this is a primary care study Patients who are member of the Belgian Diabetes Convention

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 |
| --- | --- |
| 1<br>Control group | |
| 2<br>Benchmarking group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, LDL-cholesterol, Systolic Blood Pressure |  | Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemia, Triglycerides, Total and HDL-Cholesterol, Diastolic Blood Pressure, Waist circumference, Smoking habits, Microalbuminuria, Body Mass Index, Physical activity (Rating scale and step counter), Degree of ophthalmic control and dietary advice |  | Visit 1Visit 2 (after approximately 4 months after visit 1)Visit 3 (after approximately 8 months after visit 1)Visit 4 (after approximately 12 months after visit 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Benchmarking, quality of patient care, Diabetic Population