linjc16/ctgov huggingface dataset:
Post-Marketing Surveillance Study of OTEZLA

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica Planned registration period 2 years Planned surveillance period for 4 years from 6 months after launch

Official Title
-----------------
OTEZLA® Tablets Drug Use-Results Survey

Conditions
-----------------
Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey. Psoriasis vulgaris that is with an inadequate response to topical therapies Psoriasis arthropathica Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with PsV and PsA treated with OTEZLA Tablets<br>Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse events | Up to approximately 12 months | 
| General Improvement Rating | General Improvement Rating will be assessed by physician's observation | Approximately 1 year from administration | 
| General health assessment on VAS | Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment. | Approximately 1 year from administration | 
| Changes in physician general assessment | PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner | Approximately 1 year from administration | 
| Percentage of patients with Dermatology Life Quality Index (DLQI) | The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire | Approximately 1 year from administration | 
| Change from baseline activity for arthritis | Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method | Approximately 1 year from administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis vulgaris, Psoriasis arthropathica, Serious infections, Gastrointestinal Disorders, Serious Hypersensitivity, Weight Decrease, Vasculitis, Malignancies, Depression and Suicidal Ideation
A Prospective Virtual Study of Patient Reported Behaviors and Health Outcomes in Individuals With COVID-19

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to identify and describe patient behaviors and clinical outcomes among patients who have tested positive for mild to moderate COVID-19.

Detailed Description
-----------------
This virtual observational cohort study will describe patient behaviors and clinical outcomes of subjects who tested positive for COVID-19. Among those with positive tests, predictors of time to recovery, post-COVID function and outcomes will be identified. Individuals who test negative and positive for SARS-CoV-2 will be enrolled in the study.

Official Title
-----------------
Assessing Behavioral, Functional, and Clinical Patient-Reported Outcomes (PROs) in Subjects Diagnosed With COVID-19

Conditions
-----------------
SARS-CoV-2 Acute Respiratory Disease

Intervention / Treatment
-----------------
* Other: SARS-CoV-2 Positive
* Other: SARS-CoV-2 Negative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18 years Individuals with a valid diagnostic COVID-19 test result Exclusion Criteria: - Unable or unwilling to provide informed consent

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

| Intervention/Treatment |
| --- |
|Other: SARS-CoV-2 Positive|Participants who have tested positive for SARS-CoV-2, both with and without symptoms|
|Other: SARS-CoV-2 Negative|Participants who have tested negative for SARS-CoV-2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify and describe patient behaviors and clinical outcomes among patients who have tested positive for COVID-19 |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe recovery in patients with test-confirmed COVID-19 infection including time to recovery and functional improvement |  | Up to 12 months | 
| To develop prediction tools for time to recovery, function and outcomes in patients with COVID-19 identified by home testing |  | Up to 12 months | 
| To describe users and the utilization of COVID-19 home testing over time by geography, demographics, and comorbidity |  | Up to 12 months | 
| To describe the feasibility of COVID-19 home testing |  | Up to 12 months |
The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure

Study Overview
=================
Brief Summary
-----------------
The evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.

Official Title
-----------------
The Effects of Dark Chocolate on Blood Pressure in Mildly Hypertensive Individuals

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Dietary Supplement: Dark chocolate
* Other: Dietary counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 25-65 years resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg BMI 25.0- 29.9 Exclusion Criteria: smoking regular medication for hypertension, cardiovascular disease, diabetes or asthma

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dark chocolate, dietary counselling<br>Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks. | Dietary Supplement: Dark chocolate<br>* Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.<br>|
| Active Comparator: Dietary counselling<br>Usual snacks are limited. | Dietary Supplement: Dark chocolate<br>* Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.<br>Other: Dietary counselling<br>* Usual snacks are limited.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systolic and diastolic blood pressure | Usual daily snack is replaced by 50 g dark chocolate for a period of 8 weeks. During the control period, the same usual snack is limited in the diet, but without the replacement with the dark chocolate. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure |  | 8 weeks | 
| Blood lipids, inflammation markers, plasma levels of cocoa polyphenols |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, cocoa, dark chocolate, blood pressure monitoring, ambulatory, flavanols
A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Detailed Description
-----------------
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.

Official Title
-----------------
A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: CT-P47
* Biological: EU-approved RoActemra,


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth Exclusion Criteria: A medical history and/or condition that is considered significant Clinically significant allergic reactions, hypersensitivity History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis Active or latent Tuberculosis History of malignancy Previous exposure to tocilizumab or any drug that targets IL-6

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P47<br>162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: CT-P47<br>* 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)<br>|
| Active Comparator: EU-approved RoActemra<br>162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: EU-approved RoActemra,<br>* 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective | To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf) | up to Day 43 | 
| Primary objective | To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) | up to Day 43 | 
| Primary objective | To demonstrate PK similarity in terms of Maximum serum concentration (Cmax) | up to Day 43 |
Inflammation: Correlates and Prognosis in Framingham

Study Overview
=================
Brief Summary
-----------------
To determine the relation between cardiovascular disease risk factors and systemic markers of vascular inflammation in the Framingham Study cohort.

Detailed Description
-----------------
BACKGROUND: Recent epidemiologic evidence suggests that inflammation plays a major role in the development of coronary artery disease. High sensitivity C-reactive protein assays have been shown to be independent risk factors for the development of atherosclerosis. Measurements of C-reactive protein also adds to the predictive value of lipid levels in determining the risk of cardiovascular disease. Levels of inflammatory markers may also correlate with response to commonly used lipid lowering agents. The exact role of inflammation in coronary artery disease is not clear; however, it has been suggested that inflammation may be a marker of subclinical cardiovascular disease, or may indicate the presence of vulnerable plaque. In addition to being a possible causative agent in the development of atherogenesis, it has been postulated that inflammatory markers may reflect events that predict the development of myocardial events. The fact that agents such as aspirin and pravastatin, which are known to have anti-inflammatory effects, are effective agents in the prevention of atherosclerosis suggests the possibility that prevention of inflammation may play an important role in reduction of risk for cardiovascular disease. DESIGN NARRATIVE: The study assessed inflammatory markers in 3,765 men and women of the Framingham Study. The markers included inflammatory (C-reactive protein, fibrinogen, soluble intercellular adhesion molecule-1, endothelin-1, monocyte chemotactic protein-1, tumor necrosis factor-alpha) and oxidative stress markers (8-epi-PGF 2alpha, thromboxane B2). The relation between CVD risk factors and systemic markers of vascular inflammation was determined. The relations between inflammatory markers, endothelial dysfunction, and subclinical disease were analyzed. Markers of inflammation were related to prevalent and incident cardiovascular disease events adjusting for standard risk factors. The central hypothesis was that inflammatory markers were independent risk factors for cardiovascular disease events with endothelial dysfunction operating in the causal pathway. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Coronary Disease, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
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 |
| --- | --- | --- |
A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of the Egalet® controlled release formulation to an immediate release Carvedilol tablet.

Official Title
-----------------
A Phase II, Multi-center, Multiple-dose, Double-blind, Randomized, Crossover Study Comparing the Pharmacodynamic Effects of a Once-daily Controlled-Release Carvedilol (CRC; Egalet® Formulation) and an Immediate-Release Carvedilol (IRC) Formulation in Patients With Primary Hypertension

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

Intervention / Treatment
-----------------
* Drug: Carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of mild or moderate primary hypertension Be able to tolerate a 2 week washout phase followed by a 2 week Placebo run- in phase Be minimum 18 years of age Exclusion Criteria: Be intolerant to alfa- or beta-blockers Have secondary causes of hypertension Be taking more than two antihypertensive medications

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Egalet carvedilol | Drug: Carvedilol<br>* 50 mg<br>|
| Active Comparator: 2<br>Coreg | Drug: Carvedilol<br>* 50 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to 3 weeks treatment in systolic blood pressure at the end of five minutes of sub-maximal exercise |  | 15w | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Heart Rate from baseline to 3 weeks treatment measured at the end of five minutes of sub-maximal exercise |  | 15w | 
| Safety |  | 15w |
Postural Balance and Stability Among Patients With Cervical and Back Pain

Study Overview
=================
Brief Summary
-----------------
High percentage of chronic back pain is due to spinal stenosis. The clinical picture is of 'neurogenic claudication' which effects postural balance and stability. If conservative treatment fail to improve symptoms, an invasive treatment which includes spinal decompression can be done. The research is an observational prospective one, pre and post operational intervention. The aim is to examine whether an operational intervention improves quality of life, pain, postural balance an stability among patients. It's important to clarify, that although there is operational intervention, the research is observational. The decision weather to operate or not, is not a part of the research. The investigators assume that since there is a population that independently going through an operation, the investigators can observe this population and evaluate different aspects of the operation outcomes.

Official Title
-----------------
Postural Balance and Stability Among Patients With Cervical and Back Pain

Conditions
-----------------
Spinal Stenosis, Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from back or neck pain Patients that are candidates for operational intervention Exclusion Criteria: Pregnant women Patients who had a spinal operation in the past.

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 |
| --- | --- |
| Intervational<br>Patients with back or neck pain who are a candidates for operational intervention. | |
| Control<br>Men or women who haven't seek for spine surgery consultation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic postural balance tests |  | 6 months | 
| Static postural balance tests |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and quality of life questionnaires |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal stenosis, Spinal decompression, Postural balance, Neurogenic claudication
Deep-Learning for Automatic Polyp Detection During Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine whether a combination of colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma detection rate compared to standard colonoscopy.

Official Title
-----------------
Deep-Learning for Automatic Polyp Detection During Colonoscopy

Conditions
-----------------
Screening Colonoscopy

Intervention / Treatment
-----------------
* Device: Computer Algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for routine colonoscopy for screening and/or surveillance purposes. Ability to provide written, informed consent and understand the responsibilities of trial participation Exclusion Criteria: People with diminished cognitive capacity. The subject is pregnant or planning a pregnancy during the study period. Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed) Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation) Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation). Patients with inflammatory bowel disease Patients with any polypoid/ulcerated lesion > 20mm concerning for invasive cancer on endoscopy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening Colonoscopy<br>Patients undergoing standard screening or surveillance colonoscopy will be included | Device: Computer Algorithm<br>* This device is a computer algorithm that runs in the background during routine screening or surveillance colonoscopy that is designed to aid in the detection of polyps<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate | the proportion of colonoscopic examinations performed that detect one or more polyp | 1 Day |
Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

Study Overview
=================
Brief Summary
-----------------
To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

Official Title
-----------------
A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ≥18 years or older for screening mammography Able and willing to comply with study procedures, and have signed and dated the informed consent form The subject is surgically sterile or postmenopausal Exclusion Criteria: Pregnant or trying to become pregnant Has signs or symptoms of breast cancer Has been previously included in this study Has breast implants Has a history of breast cancer and is in active treatment Has breasts too large to be adequately positioned for the DBT examination

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammography, mammogram, breast, Abnormal and normal breast tissue