linjc16/ctgov huggingface dataset:
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.

Detailed Description
-----------------
The objective of this study is to determine how effective a plug made out of human bone (called CR-Plug) will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).

Official Title
-----------------
Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR Plug) for Repair of Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure

Conditions
-----------------
Knee Injury

Intervention / Treatment
-----------------
* Other: CR Plug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are male or female at least 18 years of age and up to 55 years of age Must be skeletally mature Have a grade III or IV lesion in femoral condyle Exclusion Criteria: Skeletally immature Osteoarthritic knees, osteonecrotic knees, osteophyte formation Use of any investigational therapy within thirty (30) days prior to the first visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CR Plug BackFill<br>Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site | Other: CR Plug<br>* CR Plug will be placed in the harvest site<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI to Evaluate Success of Outcome. | The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively. The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cartilage injury, OATS, Knee injury, allograft, autograft
Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.

Official Title
-----------------
A Randomised, Placebo-controlled Single-blind, Single-centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD4818
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Body Mass Index (BMI) between 18.0-27.0 kg/m2 No clinically relevant abnormal findings Exclusion Criteria: Acute illness which requires medical intervention Definite or suspected personal history of adverse drug reactions or drug hypersensitivity. Clinical relevant disease or disorder (past or present) A history of respiratory disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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: 1<br>AZD4818 | Drug: AZD4818<br>* Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry |  | During the study | 
| Lab assessment |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Japan, Japanese, inhalation
Optical Clearing of the Skin in Conjunction With Laser Treatments

Study Overview
=================
Brief Summary
-----------------
The research hypothesis is that topical application of a mixture of pre-polymers of polypropylene glycol and polyethylene glycol (an optical clearing agent) will reduce skin light scattering, increasing the amount of light reaching the target for diagnostic as well as therapeutic purposes.

Detailed Description
-----------------
The researchers expect that application of the optical clearing agent for treatment of benign vascular lesions, tattoos, nevus of Ota, hypertrichosis, scars, acne and sebaceous hyperplasia will result in decreased reflectance of the predominant color from the surface of skin (decreased red light scattering in case of benign vascular lesions, etc) as compared to the control group. greater Optical Coherence Tomography a non-invasive light based imaging method imaging depth as compared to the control group. greater improvement in the treatment outcome (decrease in the erythema index following laser treatment of vascular lesions as compared to the laser alone group; improved lightening of the tattoo or nevus of Ota as compared to the laser treatment alone group; significant decrease in hair re-growth as compared to laser treatment alone in patients seeking hair removal; greater improvement of scars, acne and sebaceous hyperplasia).

Official Title
-----------------
Optical Clearing of the Skin in Conjunction With Laser Treatments

Conditions
-----------------
Tattoos, Port Wine Stain, Nevus of Ota, Scars, Acne, Hypertrichosis, Sebaceous Gland Diseases

Intervention / Treatment
-----------------
* Device: Optical Clearing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18 years and older Lesion diagnoses in an area measuring 3 cm2 or more on any body site Apparent good health Exclusion Criteria: Pregnant women History of cutaneous photosensitivity History of photodermatoses

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical Clearing<br>Optical Clearing | Device: Optical Clearing<br>* Optical Clearing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measure is to evaluate the optical clearing effects of the combination mixture of pre-polymers of polypropylene glycol and polyethylene glycol. |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sebaceous hyperplasia
Doppler Flow Measurements in Patients With Misoprostol Treatment for Arrested Pregnancy

Study Overview
=================
Brief Summary
-----------------
Testing the whether Doppler studies after cytotec treatment can predict success of treatment.

Detailed Description
-----------------
All women who are treated with Cytotec for a missed abortion at 1st trimester will have a follow up ultrasound exam. Doppler measurements will be performed but will be hidden from the clinicians. After the conclusion of treatment, data on Doppler would be vevealed in order to see if positive Doppler after Cytotec is predictive of failure of treatment or the need in several doses of cytotec.

Official Title
-----------------
Testing the Connection Between the Existence of Endometrial Flows With Doppler Examination if the Treatment Cytotec Success in Women With Miss Abortion

Conditions
-----------------
Missed Abortion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with miss abortion who choose treatment with cytotec Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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
-----------------
Missed abortion, early pregnancy loss.
Tin Filter Calcium Scoring

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.

Official Title
-----------------
Ultra Low-dose Coronary Artery Calcium Scoring Using Tin Filtration With Dual-source CT

Conditions
-----------------
Radiation Dose Reduction

Intervention / Treatment
-----------------
* Device: Tin Filter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be between 19-90 years of age. Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring. Subject must provide written informed consent prior to any study-related procedures being performed. Subject must be willing to comply with all clinical study procedures. Exclusion Criteria: Subject is a pregnant or nursing female. Exclude the possibility of pregnancy: By testing (urine BHCG) within 24 hours before scan, or By surgical sterilization, or Post menopausal, with minimum one (1) year history without menses. Subject has an acute psychiatric disorder or is cognitively impaired. Subject is using or is dependent on substances of abuse. Subject is unwilling to comply with the requirements of the protocol. Subject is in acute unstable condition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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: Reduction of radiation dose and diagnostic accuracy<br>Reduction of radiation dose during coronary artery calcium scoring with the use of a tin filter system. | Device: Tin Filter<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in radiation dose using the new tin-filter system |  | 2 years | 
| Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tin Filter, Coronary Artery Calcium Scoring, Radiation dose reduction
Accuracy of Non-Invasive Blood Pressure Measurement in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.

Detailed Description
-----------------
This study is a single-center blinded study that will enroll approximately 150 adult subjects. Trained auscultators will perform the standard auscultation BP measurements. They will be blinded to each other's measurements and from the ViSi measurements. The study population will be randomized into two groups based on the side of the blood pressure measurement: the left arm group (LAG) and the right arm group (RAG). The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification in order to ensure that the study subjects meet the required arm circumference and blood pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.

Official Title
-----------------
Clinical Evaluation of the Sotera VisiTM System for Measurement of Systolic and Diastolic Blood Pressures in Adults

Conditions
-----------------
Hypertension, Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is greater than 12 years of age at the time of screening. Subject's upper arm circumference is between 20cm and 55cm. Subject is willing to undergo the Informed Consent process prior to enrollment in the study. Subject is willing and able to participate for up to 60 minutes. Exclusion Criteria: Subject is participating in another clinical study that may interfere with the results of this study. Subject is unable to have a blood pressure measurement taken from either arm for any reason. Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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
-----------------
Hypertension, Hypotension, Blood pressure
Multicenter Study of Tetanus Patients in Fujian Province of China

Study Overview
=================
Brief Summary
-----------------
Background: Tetanus is a life-threatening disease in developing countries, and accompanied by a high mortality rate. China is the world's largest developing country, and Fujian Province is a typical coastal province in China with a relatively developed economy. Therefore, the purpose of this study was to investigate the epidemiology, incidence and management of tetanus in Fujian Province and to understand the current treatment and prognosis of tetanus patients in China. Methods: This was a retrospective multicenter observational study of patients who presented with a clinical diagnosis of tetanus at 5 general hospitals in Fujian. Data was analyzed using computer software system.

Official Title
-----------------
Multicenter Study of Tetanus Patients in Fujian Province of China

Conditions
-----------------
Tetanus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus. Exclusion Criteria: None.
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 |
| --- | --- | --- |
| Outcomes of the tetanus patients | The survival data of tetanus patients. | 2008-01-01 2018-10-31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hospitalization time. | The total length of hospitalization and the length of stay in the ICU. | 2008-01-01 2018-10-31 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neonatal tetanus, tetanus immunization program, drug-induced, tetanus antitoxin, critical care medicine, artificial airway
Delivery of Yamani-15/5 Chemical Solution for PAD

Study Overview
=================
Brief Summary
-----------------
This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5 (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower extremities in patients with severe peripheral arterial disease (PAD) who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).

Official Title
-----------------
In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Drug: Yamani-15/5 chemical solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Subject has severe calcific PAD who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation). Exclusion: Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer. Patients with chronic kidney disease stage V (unless on dialysis). Patients with liver cirrhosis. Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months. Patients with history of stroke in the last 3 months. Patients with unstable angina or history of myocardial infarction in the last 3 months. Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock. Women who are pregnant or nursing.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Infusion of Yamani-15/5 chemical solution. | Drug: Yamani-15/5 chemical solution<br>* A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Percent of arterial lumen patency measured by angiography and compared to baseline. | Change from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by the number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0. | Number of participants with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0. | Compared to baseline |
NETTUNIT - Italy-Tunisia Cross-border Environmental network_1

Study Overview
=================
Brief Summary
-----------------
Retrospective, case-crossover study aiming to use environmental pollutant data for assessing the associated risk of visiting the emergency room (ER) for respiratory or cardiovascular problems in the territory of the Caltanissetta Provincial Health Authority (Italy). All the ER visits for respiratory and/or cardiovascular disorders in the hospital of Gela (Italy) and Niscemi (Italy) from 2010 to 2019 will be considered.

Official Title
-----------------
NETTUNIT - Italy-Tunisia Cross-border Environmental network_1

Conditions
-----------------
Respiratory Disease, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All emergency room visits for respiratory or cardiovascular problems at the hospital of Gela (Italy) and Niscemi (Italy), from 2010 to 2019. Exclusion Criteria: Emergency room visits for other diseases.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
| Occurrence of emergency room visit for respiratory diseases (binary outcome) | Dates of emergency room visits (case days) for respiratory diseases will be retrieved and linked to air pollution data. For each case day, the binary outcome will be equal to 1. For the two control days (7 days before/after the case day), the binary outcome will be equal to 0. | From year 2010 to year 2019 | 
| Occurrence of emergency room visit for cardiovascular diseases (binary outcome) | Dates of emergency room visits (case days) for cardiovascular diseases will be retrieved and linked to air pollution data. For each case day, the binary outcome will be equal to 1. For the two control days (7 days before/after the case day), the binary outcome will be equal to 0. | From year 2010 to year 2019 |