linjc16/ctgov huggingface dataset:
Efficacy Study for Magnetic Induction to Treat Wrinkles

Study Overview
=================
Brief Summary
-----------------
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.

Official Title
-----------------
Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides

Conditions
-----------------
Wrinkles and Rhytides

Intervention / Treatment
-----------------
* Device: Biofusionary Bebe


Participation Criteria
=================
Eligibility Criteria
-----------------
The inclusion criteria for the study are: Male or female 21 to 65 years old, Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms & buttocks as determined by the study investigator, For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study, Apparently healthy, Informed consent signed by the subject. Exclusion Criteria: The exclusion criteria for the study are: History of skin hypersensitivity, Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in the treatment area, Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants, Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site, The current or recent use (within the past 12 months) of isotretinoin, Pregnancy, Infectious diseases (such as HIV) present, Are a tobacco smoker, Insulin dependent diabetic subjects, Oxygen dependent subjects, Subjects with severe chronic illness, scleroderma, or lupus, Subjects with open sores or scars in the treatment region, or Subjects with ischemia in the treatment region.

Ages Eligible for Study
-----------------
Minimum Age: 21 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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biofusionary Bebe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in cosmesis | Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in cosmesis | Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared. | 3 months |
Study to Test the Accuracy of a Prototype Handheld PT/INR Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.

Detailed Description
-----------------
This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.

Official Title
-----------------
Correlation of Feasibility Batches Using Warfarinised Blood

Conditions
-----------------
Blood Coagulation Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently taking coumadin (warfarin) Aged 18 years or older Able and willing to provide informed consent Can understand (read and write) English Exclusion Criteria: None

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 |
| --- | --- |
| Coumadin (warfarin)<br>Subjects are required to be currently receiving coumadin (warfarin) treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device | To determine the correlation of PT/INR values between an experimental and commercial device. | Fives days to collect data and up to two weeks to generate correlation graph |
Dexamethasone for Post Traumatic Headache

Study Overview
=================
Brief Summary
-----------------
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.

Official Title
-----------------
A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache

Conditions
-----------------
Post-Traumatic Headache

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Metoclopramide 10mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows: Traumatic injury to the head has occurred Headache has developed within 7 days of injury to the head Headache is not better accounted for by another diagnosis (eg, migraine or tension-type headache) The headache must be rated as moderate or severe in intensity at the time of initial evaluation. Exclusion Criteria: Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication allergies or contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone<br>Dexamethasone 10mg IV + metoclopramide 10mg IV | Drug: Dexamethasone<br>* Dexamethasone 10mg IV<br>Drug: Metoclopramide 10mg<br>* Metoclopramide 10mg IV<br>|
| Placebo Comparator: Placebo<br>Placebo IV + metoclopramide 10mg IV | Drug: Metoclopramide 10mg<br>* Metoclopramide 10mg IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate or Severe headache after Emergency Department discharge | Rating headache moderate or severe on a scale of severe, moderate, mild, or none | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained headache relief | Achieving a headache intensity of mild or none in the emergency department without use of rescue medication and maintaining that level for 48 hours without use of rescue medication. | 48 hours | 
| Post concussive symptom scale | The Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). On this validated instrument, patients rate 22 concussive symptoms on a 0 to 6 scale, with 6 signifying more severe pain | 48 hours and 7 days after emergency department discharge |
Effect of Folic Acid Treatment in Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
We seek to examine the effects of folic acid treatment on vascular function in patients with coronary artery disease. Our hypothesis is that folic acid treatment will improve vascular function

Detailed Description
-----------------
Common vascular disease states including diabetes and atherosclerosis are associated with endothelial dysfunction, characterised by reduced bioactivity of nitric oxide (NO). Folates are thought to improve endothelial function,but the mechanism by which this effect occurs is poorly understood. We propose to study the effects of folate supplementation on endothelial function in patients with coronary artery disease.

Official Title
-----------------
Effect of Folic Acid Treatment in Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of coronary artery disease Exclusion Criteria: Recent acute coronary event Renal and/or hepatic dysfunction Metallic implants

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Folic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in noninvasive measures of vascular function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in laboratory measures of vascular function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, Folic acid, Endothelial function
Computer Games to Prevent Mild Cognitive Impairment and Dementia

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to show that regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/) can prevent mild cognitive impairment (MCI) and dementia. The secondary aim of the study is to find correlations between the results of the games and the standard assessments for dementia and MCI screening such as the Rey Verbal Learning Test.

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Behavioral: Cognitive training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both gender Older than 50 years of age Exclusion Criteria: Subjects with history of head trauma, epilepsy or stroke. Diagnosis of schizophrenia Acute manic episode

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Training<br> | Behavioral: Cognitive training<br>* regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to Mild Cognitive Impairment (?CI) (Proportion of participants who develop MCI after 3 years) | Proportion of participants who develop MCI after 3 years | 3 years | 
| Conversion to dementia (Proportion of participants who develop dementia after 3 years) | Proportion of participants who develop dementia after 3 years | 3 years |
Influence of Co-Vid 19 Pandemic on Screening Mammography Single Institution

Study Overview
=================
Brief Summary
-----------------
To assess whether the COVID-19 pandemic delayed breast cancer diagnosis in Taiwan, an Asian country with a low COVID-19 incidence.

Detailed Description
-----------------
The institutional review board approved this retrospective study at a public academic medical center. The monthly volume of breast biopsies and breast cancers during the COVID-19 pandemic (between January 1 and July 31, 2020) was compared to the same period a year earlier (pre-COVID-19).

Official Title
-----------------
Influence of Co-Vid 19 Pandemic on Screening Mammography in a Single Institution

Conditions
-----------------
COVID-19, Breast Cancer

Intervention / Treatment
-----------------
* Other: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving breast exam 2019-2020 Exclusion Criteria: lost clinical follow-up

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 2019<br>Patients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed [4]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound. | |
| COVID-19 2020<br>Patients receiving biopsies with a BI-RADS assessment of 4 or 5 from mammographic or ultrasonographic exams or combinations of tests were analyzed [4]. We further categorized the biopsy data as ultrasound-guided or mammograph-guided biopsy based on procedure coding. Ultrasound-guided core needle biopsy (CNB) was performed for breast lesions visible on ultrasound. | Other: surgery<br>* Patients were divided into surgery and no disease.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breast cancer | Breast cancer or not | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Breast Cancer
Berodual® Respimat® Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Study Overview
=================
Brief Summary
-----------------
Tolerability, efficacy and handling of Berodual® Respimat® 20/50µg/dose solution for inhalation in patients with chronic obstructive airways disease in daily practice

Official Title
-----------------
Berodual® Respimat® 20/50µg/Dose Solution for Inhalation in Patients With Chronic Obstructive Airways Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Berodual® Respimat® solution for inhalation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women presenting with the symptoms of chronic obstructive airways disease were given Berodual® Respimat® 20/50µg/dose solution for inhalation only where this was considered necessary in medical terms Patients who have not been treated prior to the post-marketing surveillance study as well as patients who have been treated with Berodual® metered dose inhaler (MDI) or other respiratory medications prior to the Post-Marketing Surveillance Study could be included Exclusion Criteria: Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the Basic Product Information
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic obstructive airways disease patients<br> | Drug: Berodual® Respimat® solution for inhalation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in overall severity of clinical picture rated on 3-point scale |  | up to 12 weeks | 
| Change in breathlessness rated on a 4-point scale |  | up to 12 weeks | 
| Change in restriction of activity due to breathlessness rated on a 4-point scale |  | up to 12 weeks | 
| Change in number of awakening due to nocturnal breathlessness rated on 4-point scale |  | up to 12 weeks | 
| Global assessment of efficacy by the patients rated on 5-point scale |  | after 4, 8 and 12 weeks | 
| Global assessment of efficacy by the investigator rated on 5-point scale |  | after 4, 8 and 12 weeks | 
| Number of patients with adverse drug reactions |  | up to 12 weeks | 
| Assessment of tolerability on a 5-point scale |  | after 4, 8 and 12 weeks |
The Efficacy of Early Amniotomy for Induction of Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to investigate the efficacy of early amniotomy on reducing both the duration of labor and the frequency of dystocia in nulliparous women undergoing an induction of labor. This research project is a prospective, parallel clinical trial, in which subjects are randomized into one of two treatment groups: those who undergo early amniotomy and those who do not undergo early artificial rupture of the amniotic membranes.

Official Title
-----------------
The Efficacy of Early Amniotomy for Induction of Labor

Conditions
-----------------
Labor, Induced

Intervention / Treatment
-----------------
* Procedure: Amniotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age > 37 weeks (using established National Institute of Child Health and Human Development [NICHD] dating criteria) Nulliparous (i.e., first term pregnancy) Admitted to the hospital for induction of labor Singleton pregnancy Fetal head applied to the cervix The ability to understand the requirements of the study, as determined by the study nurse Exclusion Criteria: Premature rupture of amniotic membranes Cervical dilation > 4 cm Vaginal bleeding Major fetal abnormalities that are known at time of admission
Sexes Eligible for Study
-----------------
Female

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Amniotomy|nan|

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
-----------------
Induction of labor
Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method

Study Overview
=================
Brief Summary
-----------------
The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback). The patient will then be subjected to evaluation scales that allow to evaluate the subjective improvement of the state of well-being after treatment ENF (Electro Neuro Feedback) generates waveforms that change automatically when the impedance of the skin changes according to a compensation algorithm, i.e. according to Feedback (Feedback). T

Official Title
-----------------
Effects of Treatment With ENF (Electro Neuro Feedback) in the Reduction of Post-surgical Hematoma in Patients Undergoing Hip Replacement: Evaluation With Ultrasound Method

Conditions
-----------------
Post-surgical Hematoma, Hip Replacement , Surgery

Intervention / Treatment
-----------------
* Other: sessions with ENF (Electro Neuro Feedback).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gender: male and female Age: 35-85 years include Entry into the hospital rehabilitation program lasting at least 5 days following hip replacement surgery Absence in history of neurological or psychiatric disorders. Signature of the Informed Consent and consent to collaborate in all the procedures of the study Exclusion Criteria: Presence of severe neurological / psychiatric pathologies to sign the Informed Consense of serious cardiological pathologies that can compromise patient safety of Pace Maker or spinal cord stimulators or other subcutaneous electronic instruments of active tumors in the treatment area

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: sessions with ENF (Electro Neuro Feedback).|The study evaluates patients with clinical evidence of post-surgical hematoma / seroma after hip replacement surgery. These patients will undergo ultrasound evaluation in the 4th (+/- 2) day post surgery, in which triaxial parameters of the hematoma will be measured. This evaluation will then be repeated after 5 treatment sessions with ENF (Electro Neuro Feedback).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of post-surgical hematoma measured by ultrasound method with triaxial measurement after 5 treatment sessions with ENF |  | at the end of Cycle 5 ( every cycle during 5 days) |