linjc16/ctgov huggingface dataset:
Assessing Perceived Versus Actual Knowledge and Quality of Life in Pre-Dialysis Chronic Kidney Disease (CKD) Patients

Study Overview
=================
Brief Summary
-----------------
Aims: The investigators' primary objective is to assess both perceived and actual disease knowledge in local pre-dialysis Chronic Kidney Disease (CKD) patients. The investigators hypothesize that actual disease knowledge is poorer than perceived. As the secondary objectives, the investigators will also assess the HRQoL and examine the association between level of knowledge and HRQoL in pre-dialysis CKD patients. The investigators hypothesize that HRQoL of pre-dialysis CKD patients is poorer than that of the general population while pre-dialysis CKD patients with greater disease knowledge have a better HRQoL than those with poorer knowledge. Methodology: A survey was developed to assess both perceived and actual knowledge on five aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of CKD and its complications and renal replacement therapy (RRT) options. For the assessment of HRQoL, the following questionnaires will be used - Kidney Disease Quality of Life-Short Form (KDQOL-SF) version 1.3, EuroQoL 5 Dimensions (EQ-5D), Family Functioning Measure (FFM), and Oslo-3 Social Support Scale (OSS-3). All study questionnaires will be provided in 3 main languages - English, Chinese and Malay. A standardized data collection form was developed to retrospectively collect demographic and clinical information from the patients' electronic medical records and patient charts. Descriptive statistics will be used to report all results.

Official Title
-----------------
Assessing Perceived Versus Actual Knowledge and Quality of Life in Pre-Dialysis CKD Patients

Conditions
-----------------
Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients at least 21 years of age, able to read English, Chinese or Malay, have stage 3 to 5 CKD as identified from their medical records, but are not receiving dialysis. Exclusion Criteria: patients who do not consent, have already been started on dialysis, are cognitively impaired as assessed by the recruiter or unable to fill up questionnaires on their own.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Predialysis
Ultrasound Guided Radial Artery Catheterization

Study Overview
=================
Brief Summary
-----------------
Comparing an novel technique ( oblique view) during ultrasound guided radial artery catheterization versus Transverse and longitudinal views

Official Title
-----------------
Ultrasound Guided Radial Artery Cathetrization, A Novel Technique.

Conditions
-----------------
Arterial Catheterization, Peripheral

Intervention / Treatment
-----------------
* Procedure: radial artery Catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with clear indication to radial artery catheterization like hemodynamic instability or the need of frequent arterial samples Exclusion Criteria: refusal, Peripheral arterial diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oblique<br>Ultrasound guided radial artery catheterization using oblique view obtained by tilting the US probe 30-45 degrees over the course of the artery | Procedure: radial artery Catheterization<br>* Insertion of radial artery catheter for sampling and blood pressure measurement<br>|
| Active Comparator: Transverse group<br>Ultrasound guided radial artery catheterization using transverse view | Procedure: radial artery Catheterization<br>* Insertion of radial artery catheter for sampling and blood pressure measurement<br>|
| Active Comparator: Longitudinal group<br>Ultrasound guided radial artery catheterization using longitudinal view | Procedure: radial artery Catheterization<br>* Insertion of radial artery catheter for sampling and blood pressure measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of radial artery cathertrization |  | postoperate 72 hours |
Prospective Observational Study of Difficult Intravenous Access in the Operating Room

Study Overview
=================
Brief Summary
-----------------
This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.

Official Title
-----------------
Prospective Observational Study of Difficult Intravenous Access in the Operating Room

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

Intervention / Treatment
-----------------
* Other: Recording number of IV attempts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 0-18 years of age Having surgery at Nationwide Children's Hospital Exclusion Criteria: Pre-existing IV upon arrival to the operating room

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 |
| --- | --- |
| Difficult intravenous access<br>Recording number of IV attempts in the operating room prior to surgery start. | Other: Recording number of IV attempts<br>* Recording number of IV attempts in the operating room<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time it takes to insert an IV |  | between 1 to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated difficulty | Provider's prediction of how difficult it will be to start the IV on a Likert scale of 1-10, with 10 being the most difficult. | Baseline | 
| Actual difficulty | Provider's assessment of how difficult the actual IV insertion was on the same Likert scale. | between 1 to 30 minutes |
The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the biodistribution of a new agent 1-L-(2 deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate whether it can be used to image cancer, autoimmune disease, and inflammation

Official Title
-----------------
The Biodistribution of 1-L-(2 Deoxy-2,- 18 Fluoroarabinofuranosyl) Cytosine ([18F]L-FAC) in Healthy Subjects and Patients With Cancer, Autoimmune and Inflammatory Diseases

Conditions
-----------------
Autoimmune Diseases, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than 18 years of age women of childbearing potential will undergo a pregnancy test free of charge patients with hematological malignancies, solid tumors or autoimmune disorders

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with cancer<br>patients with hematological malignancies and solid tumors | |
| patients with autoimmune dosorders<br>patients with Rheumatoid arthritis, Crohns's disease, systemic lupus erythematosus. | |
| healthy subjects<br> | |

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
-----------------
imaging probe, cancer, inflammatory tissue, inflammatory diseases
Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain

Study Overview
=================
Brief Summary
-----------------
To investigate if the level of preoperative lower back pain has the effect on the acute postoperative pain after gynecological laparoscopy

Official Title
-----------------
Predicting Acute Postoperative Pain by the Preoperative Lower Back Pain in the Gynecological Laparoscopy

Conditions
-----------------
Benign Gynecological Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women scheduled for elective gynecological laparoscopy Exclusion Criteria: psychiatric disease eg. anxiety, depression, etc. diagnosed as cancer the use of vasoactive drug chronic pain except lower back pain

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
| the intensity of acute postoperative pain | The intensity of pain is assessed using the numeric rating scale (0=no pain; 10=the worst pain) | during 30 min in the recovery room |
Emergency/Compassionate Use - AMPLATZER Duct Occluder

Study Overview
=================
Brief Summary
-----------------
Emergency/compassionate use for the AMPLATZER Duct Occluder

Conditions
-----------------
Patent, Ductus, Arteriosus

Intervention / Treatment
-----------------
* Device: Device closure with the AMPLATZER Duct Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency/compassionate use for patients not meeting the inclusion crtieria for the AMPLATZER Duct Occluder clinical trial
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Device closure with the AMPLATZER Duct Occluder|Device closure with the AMPLATZER Duct Occluder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Steady State Study of Codeine Sulfate

Study Overview
=================
Brief Summary
-----------------
Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.

Official Title
-----------------
A Single Dose, 1-Period, 1-Treatment Study of Codeine Sulfate 15 mg Tablets Under Steady State Conditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Codeine Sulfate


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 codeine sulfate 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Codeine Sulfate|15 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 6 days |
Outcome of Steroid Therapy for Myocardial Inflammation in Scleroderma

Study Overview
=================
Brief Summary
-----------------
Primary myocardial involvement is common in scleroderma, effected to pericardium, vascular, conducting defect and especially myocardium. Cardiac MRI is widely used for assessment of cardiac involvement in scleroderma, both structural and functional pathology. Cardiac MRI has a diagnostic accuracy of 85% for the detection of myocardial inflammation. Nowadays, the treatment of myocardial inflammation in scleroderma is uncertain. The investigator's study aims to define the cardiac outcome after moderate dose steroid therapy in the patients who have myocardial inflammation detection by cardiac MRI.

Official Title
-----------------
Outcome of Myocardial Inflammation After Steroid Therapy in Thai Systemic Sclerosis Patients: an Open Label Study

Conditions
-----------------
Myocardial Inflammation

Intervention / Treatment
-----------------
* Drug: Prednisolone and taper


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • The adult scleroderma patients who were defined as having myocardial inflammation by cardiac MRI. Exclusion Criteria: Current infection that needs systemic antibiotic therapy Active viral hepatitis B or C Uncontrolled diabetes mellitus

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Moderate dose steroid therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone<br>The patient who has detected myocardial inflammation from cardiac MRI from baseline is given prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24. | Drug: Prednisolone and taper<br>* Prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24.<br>* Other names: Moderate steroid therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing of degree of myocarditis evaluated by cardiac MRI after treatment compare to baseline | Myocarditis is defined as inflammatory disease of the myocardium according to the cardiac MRI Lake Louise criteria at least 2 of the following criteria: Regional or global myocardial signal intensity increased in the T2-weighted images; Increased global myocardial early enhancement ratio between the myocardium and skeletal muscle in the gadolinium-enhanced T1-weighted images; and, At least 1 focal lesion with nonischemic regional distribution in the inversion-recovery-prepared, gadolinium-enhanced, T1-weighted images (delayed enhancement). Response to treatment is defined as any reducing of degree of myocarditis without any progression of myocardial fibrosis or scarring when compared to the cardiac MRI baseline | 24 weeks |
Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

Study Overview
=================
Brief Summary
-----------------
Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.

Official Title
-----------------
An 8 Week Extension to a Randomized, Double-blind, Parallel Group, Active-controlled, Multi-center, 14 Week Study to Evaluate the Effectiveness of a Valsartan Versus and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy

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

Intervention / Treatment
-----------------
* Drug: valsartan
* Drug: amlodipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria MSSBP> 140 mm Hg, and/or MSDBP> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study Exclusion criteria Premature discontinuation in the core study or failure to comply with the core study protocol Any patient that the investigator decides should not participate in the extension Other protocol-defined inclusion/exclusion criteria may apply

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

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

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: valsartan|nan|
|Drug: amlodipine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks |  |  | 
| Adverse events after 22 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension,, stage 1 hypertension,, stage 2 hypertension,, valsartan,, amlodipine,
Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate long-term outcome of treatment(percutaneous coronary intervention or coronary-artery bypass graft) in unprotected left main coronary artery stenosis in Korea.

Official Title
-----------------
Ten-Year Outcomes of Stents Versus Coronary-Artery Bypass Grafting for Left Main Coronary Artery Disease in Korea : Multicenter, Long-term, Observational Trial

Conditions
-----------------
Coronary Arteries

Intervention / Treatment
-----------------
* Procedure: percutaneous coronary intervention or coronary-artery bypass graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unprotected left main disease Exclusion Criteria : No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| unprotected left main<br>undergone percutaneous coronary intervention or coronary artery bypass graft | Procedure: percutaneous coronary intervention or coronary-artery bypass graft<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite event | all-cause death, myocardiac infarction, revascularization | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left main, unprotected, percutaneous coronary intervention, coronary-artery bypass graft
Safety Study of Ophthalmic Solution in Healthy, Normal Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of R89674 0.25% ophthalmic solution in healthy normal volunteers

Official Title
-----------------
A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of R89674 0.25% Ophthalmic Solution in Healthy, Normal Volunteers

Conditions
-----------------
Healthy Volunteers Eligible for Study; Drug Being Developed for Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: R89674 (generic name not yet established)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy normal volunteers age >=3 years with normal ocular health and a best-corrected logMAR score of 0.3 or better - Exclusion Criteria: intraocular surgery and/or ocular surgical intervention within last 3 months, refractive surgery within last 6 months, active ocular disorder other than refractive disorders, breastfeeding women, pregnant female < 18 years of age -

Ages Eligible for Study
-----------------
Minimum Age: 3 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: R89674 (generic name not yet established)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events; biomicroscopy and visual acuity at baseline and Days 7, 21, and 42; ophthalmoscopy and intraocular pressure at baseline and Day 42; physical examination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No additional endpoints |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers, safety, ocular, allergic conjunctivitis, ophthalmic