linjc16/ctgov huggingface dataset:
EYESHOT (EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian Coronary Care Units)

Study Overview
=================
Brief Summary
-----------------
This register will evaluate the use of different antithrombotic therapies, combinations of different drugs routinely used during any stage of hospital admission, with their timing, dosage and mode of administration, in patients with a diagnosis of Acute Coronary Syndrome in the Italian Coronary Care Unit during a study period of three weeks

Official Title
-----------------
EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian CCUs Registry

Conditions
-----------------
Acute Coronary Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: All consecutive patients discharged with a diagnosis of Acute Coronary Syndrome ( Non ST elevation or ST Elevation) undergoing myocardial revascularization or conservative treatment , admitted to the Coronary Care Unit during the observation period established. Age ≥ 18 years Signed informed consent Exclusion criteria: Patients enrolled in clinical trials of intervention Diagnosis of Acute Coronary Syndrome caused by confounding comorbidities (eg . Trauma or surgery after non- cardiac ) Patients already enrolled in eyeshot from another center.

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 |
| --- | --- | --- |
| Antithrombotic drugs in patient undergoing percutaneous transluminal coronary angiography, coronary artery bypass graft or no coronary revascularization |  | Participants will be followed for the duration of hospital stay, an expected average period of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital ischemic and hemorrhagic events |  | Participants will be followed for the duration of hospital stay, an expected average period of 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute coronary syndromes, Intensive Care Unit
Assessment of Myocardial Viability Using Multidetector Computed Tomography

Study Overview
=================
Brief Summary
-----------------
To perform a comprehensive evaluation of multidetector CT myocardial enhancement patterns in patients with an acute ST elevation MI. In particular we plan to assess the relationship between regions with early hypoperfusion and/or late hyperenhancement, and myocardial viability.

Detailed Description
-----------------
20 patients admitted to ICCU with ST elevation MI, and treated with primary angioplasty on admission, will undergo between day 2 and 7 post-MI the following exams: a) multidetector CT: regular scan plus late scan at 10 minutes, to evaluate coronary arteries, regional function and myocardial enhancement, b) echocardiography with echo-contrast to evaluate function and size of abnormally contracting region and remodeling, c) nuclear studies: rest early and late Thallium SPECT, to evaluate perfusion and viability. At 3 months a second echo will be performed to assess recovery of abnormal segments. The perfusion defects on MSCT will be compared with the other modalities and at 3 months will be used to evaluate recovery of myocardial function i.e. viability. Parameters that will be evaluated include opacity of hypoenhanced segments, ratio of normal to abnormal segments, change in opacity between early and late scans, size and transmurality of hypoenhanced segments, and their relation to regional contraction.

Official Title
-----------------
Non-Invasive Assessment of Myocardial Viability Using Multidetector Computed Tomography Post Acute Myocardial Infarction

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute ST elevation myocardial infarction after primary angioplasty Exclusion Criteria: iodine allergy renal failure old MI arrhythmia inability to perform 20 second breath-hold

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of viability from myocardial enhancement patterns |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDCT, viability
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)

Study Overview
=================
Brief Summary
-----------------
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.

Official Title
-----------------
A Multicenter Study to Assess the Safety and Effectiveness of the Genio Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Adults Subjects

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Genio™ system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) limitations Likely suffer from moderate to severe OSA based on history and physical Has either not tolerated, has failed or refused positive airway pressure (PAP) treatments Willing and capable of providing informed consent Exclusion Criteria: Inadequately treated sleep disorders other than OSA Significant co-morbidities that contraindicates surgery or general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 75 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: Genio Therapy<br>The Genio™ system is an implantable neurostimulation system comprised of one implanted device | Device: Genio™ system<br>* The Genio™ device is a permanent implant. It is implanted in the chin area and delivers stimulation to both hypoglossal nerve branches (i.e., the left and right branches). The implant does not include a battery or an embedded software and is externally powered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device-related SAEs | Incidence of device-related SAEs recorded during the study for a period of 12 months post-surgery. | 12 months | 
| Change in Apnea Hypopnea Index (AHI4%) | percentage of responders at 12 months based on AHI4 | 12 months | 
| Change in Oxyhemoglobin Desaturation Index (ODI4%) | percentage of responders at 12 months based on ODI4 | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypoglossal nerve stimulation
Management of Cervical Intraepithelial Neoplasia Grade 2

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare two management options for CIN 2. This randomized clinical trial performed between 2003 and 2006. A series of 90 Brazilian women diagnosed as CIN2 were randomized into two groups: 1) 45 whose lesion was excised and,2) 45 women subjected to follow-up at 3-month intervals for 12 months.

Detailed Description
-----------------
Pap smear and colposcopy were performed at every follow-up visit and all lesions were completely visible at colposcopy. The researchers purpose was to make some comments about the over treatment and the misclassification of CIN 2.

Official Title
-----------------
Management of Cervical Intraepithelial Neoplasia Grade 2

Conditions
-----------------
Cervical Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Procedure: Excision of the lesion
* Other: Follow-up for spontaneous regression of the lesion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological CIN2 diagnosis Exclusion Criteria: Previous CIN treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 61 Years

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

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

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 |
| --- | --- |
| Active Comparator: excision of the lesion<br> | Procedure: Excision of the lesion<br>* Surgery with Large Loop Excision of Transformation Zone (LLETZ)<br>* Other names: LEETZ;|
| No Intervention: espontaneous regression<br> | Other: Follow-up for spontaneous regression of the lesion<br>* Follow-up at last 12 months<br>* Other names: conservative managment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 43 women in the follow-up group, 44.1% experienced spontaneous regression, 20.9% had partial regression, 23.2% progressed to CIN3, and 11.6% showed persistence. 44 women whose lesion was excised, the regression rate was 90.9% |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CIN2, management
Cervix Hypoxia FAZA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look for low levels of oxygen (hypoxia) in your cervix cancer using a special x-ray test called a positron emission tomography (PET)scan. Hypoxia may have an effect on how cervix cancer grows and responds to treatments like radiotherapy and chemotherapy. Doctors at Princess Margaret Hospital have measured hypoxia in over 300 patients. The use of PET scans to measure hypoxia may be better and simpler than the methods used previously.

Official Title
-----------------
A Feasibility Study of Hypoxia Imaging in Patients With Cervix Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Conditions
-----------------
Cervix Cancer

Intervention / Treatment
-----------------
* Procedure: 18F-Fluoroazomycin Arabinoside (18F-FAZA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix TNM (7th edition) cT1-4, N0-1, M0-1 Intention to treat using radiotherapy with or without concurrent cisplatin chemotherapy according to the current treatment policies of the PMH Gynecology Group No cytotoxic anti-cancer therapy for cervix cancer prior to study entry A negative urine or serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age Ability to provide written informed consent to participate in the study Exclusion Criteria: Prior complete or partial hysterectomy Carcinoma of the cervical stump Inability to lie supine for more than 30 minutes Patients taking the drug disulfuram (Antabuse)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET FAZA imaging<br>PET FAZA imaging of tumor hypoxia in patients with cervix cancer | Procedure: 18F-Fluoroazomycin Arabinoside (18F-FAZA)<br>* A PET scan is an imaging test that uses special radioactive dyes to measure different aspects of how your cancer acts. In this study, a dye called 18F-Fluoroazomycin Arabinoside (18F-FAZA) will be used to measure hypoxia levels in tumours. Health Canada has not approved FAZA for general use, but has approved it for use in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients treated with the PET tracer FAZA to image primary tumor hypoxia in patients with cervix cancer prior to treatment with radiotherapy and concurrent cisplatin chemotherapy |  | 2 years |
Permission to Collect Blood Over Time for Research

Study Overview
=================
Brief Summary
-----------------
To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.

Official Title
-----------------
Predicting DVT Risk in GI Cancer Patients Using Plasma Biomarkers

Conditions
-----------------
Anal Cancer, Pancreatic Cancer, Gastrointestinal Neoplasms, Colon Rectal Cancer Adenocarcinoma, Esophageal Cancer, Gall Bladder Cancer, Gastric (Stomach) Cancer, Gastrooesophageal Cancer, Gastrointestinal Stromal Tumor (GIST), Hepatobiliary Neoplasm, Liver Carcinoma, Gallbladder Carcinoma, Bile Duct Carcinoma, Carcinoma of the Large Intestine

Intervention / Treatment
-----------------
* Procedure: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, >= 18 years old. There are no ethnic restrictions. Active cancers of the GI tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed TNM staging by the American Joint Committee on Cancer; stage III disease if diagnosed within 2 months and all stage IV disease Ability to understand and the willingness to sign a written informed consent document. Existing staging CT imaging study Exclusion Criteria: Life expectancy < 6 months History of deep vein thrombosis (DVT) or pulmonary embolism (PE) Known pregnancy or positive urine pregnancy test in pre-menopausal women On anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors) No CT imaging studies, or contraindications to undergoing CT imaging Existing or anticipated need for a tunneled central venous catheter Clinic visitation to Stanford Cancer center for secondary consultation purposes only Inability to give informed consent

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

| Intervention/Treatment |
| --- |
|Procedure: Observation|Standard of Care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify Biomarkers |  | 3 years |
Pulmonary Vein Isolation Outcomes With Fish Oils

Study Overview
=================
Brief Summary
-----------------
Fish oil therapy may decrease the incidence of cardiac arrhythmias. This study will test whether pre-treatment with fish oils before catheter ablation of atrial fibrillation decreases the early post operative occurrence of atrial fibrillation.

Official Title
-----------------
Pulmonary Vein Isolation Outcomes With Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid (DHA)

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Lovaza (Fish Oils)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paroxysmal Atrial fibrillation (PAF). Persistent atrial fibrillation. Persistent AF is not self-limited. Exclusion Criteria: Previous pulmonary vein isolation ablation procedure Contraindication for anticoagulation Permanent AF Severe valvular pathology Concurrent use of antiarrhythmic medications Inability to give consent Pregnancy

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lovaza (Fish Oils)|Double blinded placebo controlled|

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
-----------------
Atrial Fibrillation, Persistent, Paroxysmal, Pulmonary Vein isolation, Omega three fatty acids, Fish Oils
Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovascular Accident (CVA)

Study Overview
=================
Brief Summary
-----------------
Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography. In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our Good medical practice before the publication of prospective and randomised clinical studies.

Official Title
-----------------
Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.

Conditions
-----------------
Permeable Foramen Ovale, Cerebrovascular Accident

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: less than 55 years old occlusion of FOP after cryptogenic CVA Exclusion Criteria: characterized thromboembolic event patients who have a surgery after transitory ischemic accident

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FOP<br>Patients who already have an occlusion of POF secondary to a cryptogenic CVA and younger than 55 years old and without characterized thromboembolic events. | Other: Data collection<br>* Collection of characteristics of interauricular septum, characteristics of the CVA, and headache history. Collection of anamnesis data, surgical past history, especially at the moment of the implement of prothesis, collection of dtat of transthoracic echography, transcranial echodoppler, holter ECG, cerebral MRI.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.

Official Title
-----------------
An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Procedure: Alcohol Wipes vs. No Alcohol Wipes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female 18 years of age or older Diagnosis of RRMS Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously Exclusion Criteria: Unable to perform subcutaneous self-injection Pregnant, or trying to become pregnant, or breast feeding during the study

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection | Procedure: Alcohol Wipes vs. No Alcohol Wipes<br> <br> * Other names: Copaxone;|
| Experimental: 2<br>injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection | Procedure: Alcohol Wipes vs. No Alcohol Wipes<br> <br> * Other names: Copaxone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection |  | four weeks of Period 1 and the four weeks of Period 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection |  | four weeks of Period 1 and the four weeks of Period 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Copaxone