linjc16/ctgov huggingface dataset:
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
A study is conducted to determine the effectiveness of prism spectacles in improving visual acuity with age related macular degeneration patients and to assess the improvement in quality of life in patients by using prism spectacles.

Detailed Description
-----------------
A random sampling technique will be used to allocate patient in interventional and non-interventional group. The diagnosed patients of age-related macular degeneration are assessed for prism spectacles for near vision and prism glasses will be dispensed to the patients. Each subject will be interviewed to fill the Proforma after taking the informed consent. The results of this study will show the effectiveness of prism glasses in patients with age related macular degeneration in their daily routine near work as compared to conventional glasses.

Official Title
-----------------
Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Device: prism spectacle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having age >50 years with age related macular degeneration. Patients of both genders (male and female). Participants who will be willing to give informed consent for participation in the study. Exclusion Criteria: Presence of all ocular disease and systemic ocular pathologies able to impair visual function. Presence of disorders causing choroidal neovascularization other than age related macular degeneration. Patients with mental illness, dementia, and severe physical limitations

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

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

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

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: interventional<br>prism spectacles prescribed | Device: prism spectacle<br>* a prism is dispensed in prescription glasses<br>|
| Active Comparator: non interventional<br>presbyopia glasses prescribed | Device: prism spectacle<br>* a prism is dispensed in prescription glasses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Near and Distance visual acuity are measured in log Mar units. | Four week | 
| Visual Functional Quality of life (VFQOL) | VFQOL is measured by a validated tool VFQOL-25. | Four weeks |
Phase 3 Study of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients

Study Overview
=================
Brief Summary
-----------------
A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW-330SR2 and Pelubiprofen in Chronic Back Pain Patients.

Conditions
-----------------
Chronic Back Pain

Intervention / Treatment
-----------------
* Drug: DW-330SR2
* Drug: Pelubiprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 12 weeks by the time the trial started , and low back pain that requires analgesia administration. Class 1 or 2 back pain patients along Quebec Task Force Classification Patients with pain at least 40mm test results at visit2 The voluntary or legal guardian 's written consent to participate in this clinical trial subjects Exclusion Criteria: Severe gastrointestinal disease, heart disease, high blood pressure patients Patients with secondary causes are obvious Within 24 weeks patient who has back surgery before clinical trial participation Within 4 weeks patient who experienced psychotropic drugs, a narcotic analgesic dosage that may affect the pain sensation Within 4 weeks patient who treated steroid drug by oral or injection Within 2 weeks patient who treated MAO inhibition drugs Patients with severe respiratory depression status

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DW-330SR2<br>DW-330SR(Pelubiprofen) 45mg twice a day | Drug: DW-330SR2<br> <br> |
| Active Comparator: Pelubiprofen<br>Active Comparator(Pelubiprofen) 30mg three times a day | Drug: Pelubiprofen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of 100 mm Pain VAS |  | 28 days |
7T MRI to Evaluate Cartilage Defects in the Knee

Study Overview
=================
Brief Summary
-----------------
The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.

Detailed Description
-----------------
The investigators hypothesize that 7T MRI will be   80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of  1-2 hours for a single 7T MRI scan.

Official Title
-----------------
Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy

Conditions
-----------------
Cartilage Injury, Knee Injuries, Arthropathy of Knee, Cartilage Damage, Knee Pain Swelling

Intervention / Treatment
-----------------
* Diagnostic Test: 7 Tesla Magnetic Resonance Imaging Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Knee Symptomatology Scheduled Arthroscopic Treatment of Knee Adult (equal or greater than 18 years of age) Exclusion Criteria: Active infections Less than 18 years of age Pregnant

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 |
| --- | --- |
| 7T MRI Group<br>Patient group that receives 7 Tesla Magnetic Resonance Imaging | Diagnostic Test: 7 Tesla Magnetic Resonance Imaging Test<br>* MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) | Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee is a validated instrument utilized to grade structural abnormalities found in MRI. Only the cartilage sub-score of the full WORMS will be scored in the study. Cartilage will be scored on a range from 0-6 for 6 different regional subdivisions for a minimum score of 0 and maximum score of 36. A lower score is considered a better outcome, with a score of 0 equating to normal thickness and signal of cartilage. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
7T Magnetic Resonance Imaging, Clinical, Cartilaginous Lesion
CARE - Quality Improvement in Cardiovascular Secondary Prevention in Primary Care, Through Delegation of Consultations to the Nurse.

Study Overview
=================
Brief Summary
-----------------
Quality Improvement in Primary Care: delegation of check-ups to nurses in general practice

Official Title
-----------------
CARE - Quality Development in Cardiovascular Disease in General Practice

Conditions
-----------------
Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in secondary prevention of cardiopathy (ischaemic heart disease, claudication intermittence, thrombotic apoplexy cerebri, diabetes) who are not followed in an outpatient department. Exclusion Criteria: Patients who suffer from diabetic nephropathy will be excluded According to the general practitioners appraisal, patients who suffer from severe co morbidity can be excluded as well.

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>Patients in secondary prevention of cardiovascular disease in primary care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cholesterol, HDL -cholesterol, LDL-Cholesterol, Blood pressure, Exercise, Waist-circumference, BMI, Smoking status, fasting plasma-glucose, medication taken |  | As needed, min. baseline and after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of visits pr. patients, drop-out |  | Annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality development project, primary care nurses, cardiovascular disease, secondary prevention, follow-up
The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps

Study Overview
=================
Brief Summary
-----------------
When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp will be resected for the biopsy.

Detailed Description
-----------------
When discovering a polyp, the endoscopist uses water to wash it.Then, the endoscopist starts with i-scan 1 (OE mode 1) to observe the polyp closely .Nextly, the endoscopist give a real-time optical diagnosis with the blind of the history of patient. Considering the other polyps, the endoscopist gives a surveillance interval predictions according to the guide made by USMSTF.The confidence of the real-time optical diagnosis is divided into high confidence and low confidence.After the observation, the small and diminutive polyp will be resected and have the blinded pathology.

Official Title
-----------------
The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps :A Prospective Study

Conditions
-----------------
Colorectal Sessile Serrated Adenomas/Polyps

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The high risk for colorectal cancer screening score Patients with colorectal polyps reviewing Exclusion Criteria: 1.Inflammatory bowel disease 2. Polyposis syndrome 3. A history of colorectal cancer or surgical resection 4. Poor bowel preparation5.Not signing the informed consent 6.Severe cardiopulmonary function failure lesions, severe hypertension, cerebrovascular disease, mental disorder and coma, pregnancy, lactation can't taking the colonoscopy.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| optical enhancment endoscopy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-time diagnosis accuracy of optical enhancement in colorectal sessile serrated adenomas/polyps |  | 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-time diagnosis accuracy of optical enhancement in colorectal adenomas and hyperplastic polyps |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Sessile Serrated Adenomas/Polyps optical enhancement endoscopy
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians

Study Overview
=================
Brief Summary
-----------------
Musculoskeletal disorders and stress of employees remain a major problem in many occupations. The aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus usual care ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.

Official Title
-----------------
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians

Conditions
-----------------
Musculoskeletal Disorders, Stress

Intervention / Treatment
-----------------
* Behavioral: Biopsychosocial
* Behavioral: Reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laboratory technician Pain intensity >= 3 (scale of 0-10) Pain duration >= 3 months Pain frequency >= 3 days per week Exclusion Criteria: life threatening disease pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsychosocial<br>Biopsychosocial intervention with Individually tailored physical exercises and stress management | Behavioral: Biopsychosocial<br> <br> |
| Active Comparator: Reference<br>Reference group receiving usual care in terms of standard workplace ergonomics and physical exercises | Behavioral: Reference<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | The change in pain intensity during the last week (average value of back, neck, shoulder, elbow and hand) from baseline to 10 week follow-up between the individually tailored biopsychosocial group and reference group. 2-way analysis of variance with repeated measures will be used, with time, group and time x group as fixed factors and subject as random factor. Analyses will be controlled for pain intensity at baseline. | change from baseline to week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress | Cohens perceived stress scale | change from baseline to week 10 |
Inflammatory Markers and Adverse Outcomes in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
Longitudinal cohort of patients with chronic kidney disease followed in 3 kidney centers in Ontario. The goal is to determine whether and how rates of renal disease progression are affected by inflammatory markers, FGF23 levels, and genetic polymorphisms

Detailed Description
-----------------
This longitudinal cohort study will follow 2500 prevalent Chronic Kidney Disease (CKD)patients under the care of a nephrologist at 3 Southern Ontario Nephrology centres and all affiliated satellite centres with an estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min to determine the rate of their renal disease progression over a 36 months. All CKD patients older than 18 years of age may be included in this study. This study will analyze, with 6 month serial measurements, conventional biochemical, hormonal and metabolic parameters in addition to the demographics, clinical status, medications and blood and urine samples of these patients. This study will assess the influence of inflammation on FGF23 and genetic polymorphisms that may reflect the processes involved with disease progression.

Official Title
-----------------
CAN-AIM to PREVENT: CANadian Study, Assessing Inflammatory Markers to PRedict EVents in Nephrology sTudy

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to a nephrologist for evaluation of CKD or those currently seen by a nephrologist, with eGFR less than 60 ml/min Patients that are erythropoietin treatment naive Transplant patients with failing grafts requiring nephrologists follow-up Patients currently not receiving RRT consenting to be in the study Adults 18 years of age and older Exclusion Criteria: Functioning Organ transplant Life expectancy less than 12 months Patients currently receiving RRT or who will likely initiate RRT within 6 months Patients unable or contraindicated to receive EPREX® as erythropoietin replacement therapy for the correction of anemia related to CKD

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 |
| --- | --- | --- |
| Renal function at study censure | Estimated glomerular filtration rate after 3 years of follow-up in the study | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dialysis-dependent renal failure | Development of dialysis-dependent renal failure during observation period | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD progression, Inflammation, FGF23, Genetic biomarkers
Learning Small Bowel Capsule Endoscopy

Study Overview
=================
Brief Summary
-----------------
This project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity >90%

Official Title
-----------------
Learning Small Bowel Capsule Endoscopy

Conditions
-----------------
Endoscopy, Education, Simulation, Small Bowel Disease, Small Bowel Capsule Endoscopy

Intervention / Treatment
-----------------
* Other: Simulation training in small bowel capsule endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical Doctors in medical gastroenterology or surgery Exclusion Criteria: Prior experience with evaluation of small bowel capsule endoscopy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical doctors<br>Medical doctors with no prior experience in the evaluation of small bowel capsule endoscopy. | Other: Simulation training in small bowel capsule endoscopy<br>* Training in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic sensitivity >90% | Percentage of total number of correct diagnostic evaluated cases | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostics | Percentage of correct diagnostic description | 1.5 year | 
| Clinical consequence | Percentage of correct clinical consequence | 1.5 year | 
| Total time | Total time use for all evaluated cases. | 1.5 year |
Bleeding Risk Assessment System for Antithrombotic Therapy of ACS

Study Overview
=================
Brief Summary
-----------------
Antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (ACS), which result in lower risk of mortality and ischemic events. But, accompanied side effect of bleeding always causing worsens outcomes. Tools to evaluate risk/benefit ratio is useful in daily practice. The in-used scores, such as CRUSADE, are derived from retrospective studies, without all types of ACS and without long-term prediction. This project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in Beijing through the observational registry of ACS. With the database, establish a bleeding risk assessment system that can be used for all ACS patients and can predict the full course of antithrombotic treatment.

Official Title
-----------------
Development and Validation of a Full Course Bleeding Risk Assessment System for Antithrombotic Therapy of Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age18-85 years old Diagnosed ACS Signed informed consent form Exclusion Criteria: Any active bleeding Not tolerate to anti-thrombotic drugs A planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment Patients who died of non-bleeding causes within 24 hours after admission Noncardiac coexisting conditions that could limit life expectancy to less than 1 year Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| The number of event of bleeding | The number of event of bleeding (BARC 2 to 5) within 30 days after enrollment | 30 days | 
| The number of event of bleeding | The number of event of bleeding (BARC 2 to 5) within 1 year after enrollment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of event of bleeding | The number of event of bleeding (BARC 1 to 5) within 30 days and 1year after enrollment | 30 days and 1 year | 
| number of event of major adverse cardiovascular or cerebrovascular events | number of event of major adverse cardiovascular or cerebrovascular events within 30 days and 1year after enrollment | 30 days and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, antithrombosis