linjc16/ctgov huggingface dataset:
Prospective, Post Market Surveillance Q3-registry (POLARIS)

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System

Official Title
-----------------
Prospective, Non-randomized Post Market Surveillance Registry to Document the Clinical Performance in Routine Clinical Practice of the POLARIS Peripheral Vascular Self Expanding Stent System.

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: POLARIS Peripheral Vascular Self Expanding Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Single target de novo superficial femoral artery lesion (angiographic evidence of >50% Stenosis or occlusion) by visual estimate Rutherford category II-IV At least one patent outflow artery to the ankle. Patient signed the informed consent Exclusion Criteria: Patient with acute or subacute Thrombus Patients with hyperkoagulopathy Patients with Stenosis or occlusion where lesion crossing with guide wire is not possible Pregnancy or positive pregnancy test Previous enrolment in this Trial or other industrial Trials Patient´s inability to fully cooperate with the registry protocol Patient with cancer Treatment (life expectancy less than 2 years) Patients with renal failure

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: POLARIS Peripheral Vascular Self Expanding Stent System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from target lesion revascularization | Clinically driven | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis/ reocclusion | Defined as peak systolic velocity tatio (PSVR) > 2.4 | at 12 months | 
| Target limb amputation at the index leg (major and minor separately) |  | at 12 months | 
| All-cause death |  | at 12 months | 
| Change in resting ankle brachial index (ABI) |  | From baseline to 12 and 24 months | 
| Change in Rutherford Classification |  | From baseline to 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Superficial femoral artery, Self Expanding Stent System
Safety of the Automatic Respiration Transfer System- Timer

Study Overview
=================
Brief Summary
-----------------
The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to have their ventilator placed on a timer which at a specific time in the future stops the ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes during the use of the timer with the regular ventilator. In addition, we will evaluate whether the timer stops the ventilator and switches to CPAP at the designated time.

Official Title
-----------------
Safety of the Automatic Respiration Transfer System- Timer

Conditions
-----------------
Intensive Care Patients on a Ventilator

Intervention / Treatment
-----------------
* Device: Automatic Respiration Transfer System- Timer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ventilated patients with informed consent Exclusion Criteria: Non- ventilated patients

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Automatic Respiration Transfer System- Timer|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the Automatic Respiration Transfer System- Timer | Number of Adverse Events | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilation, timer
Laparoscopic Approach for Emergency Colon Resection

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.

Detailed Description
-----------------
Laparoscopic technique in elective colorectal surgery has been shown to be advantageous for patients compared to open technique. However, the feasibility and potential benefits of laparoscopic colorectal surgery in emergency setting has not been evaluated sufficiently. The aim of this study is to compare laparoscopic and open technique in emergency colon resections. Primary outcome is the immediate recovery after operation and secondary outcome is long-term overall and cancer-specific survival.

Official Title
-----------------
Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial

Conditions
-----------------
Laparoscopic Surgery, Colorectal Cancer, Colorectal Disorders, Emergencies, Complication of Surgical Procedure, Long-term Effects of Cancer Treatment

Intervention / Treatment
-----------------
* Procedure: Laparoscopic operation
* Procedure: Open operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients in need of emergency colon resection Exclusion Criteria: age < 18 year trauma patients reoperations acute pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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
Interventional Model Description: This is a prospective randomized controlled multicenter trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic operation<br>Laparoscopic emergency colon resection | Procedure: Laparoscopic operation<br>* Operation<br>|
| Active Comparator: Open operation<br>Open emergency colon resection | Procedure: Open operation<br>* Operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative morbidity | Postoperative morbidity evaluated by Clavien-Dindo classification | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infections | Surgical site infections, superficial and deep | 30 days | 
| Long-term Survival | Long-term overall and cancer-specific survival | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery, Emergency surgery, Colorectal
Correlation Between Quantitative Analysis of Coronary MRA and FFR

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate whether quantitative analysis of coronary MR angiogram would improve the detection of functionally-significant coronary artery stenosis.

Detailed Description
-----------------
Coronary MR angiography is performed with a 3.0-T imager with 32-channel coils. Qunatitative analysis of coronary MR angiogram is evaluated on the basis of the signal intensity (SI) profile along the vessel. Quantitative analysis of coronary MR angiogram (QCMRA) is calculated as [1 - (SImin/SIref)] x 100, where SImin is minimal SI and SIref is corresponding reference SI. Diagnostic performance of quantitative analysis of coronary MR angiogram for predicting functional significant coronary stenosis was evaluated by using fractional flow reserve (FFR) as the reference standard.

Official Title
-----------------
Quantitative Analysis of 3T Whole Heart Coronary Magnetic Resonance Angiogram Improves Detection of Functionally Significant Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease, Magnetic Resonance Angiography, Fractional Flow Reserve

Intervention / Treatment
-----------------
* Diagnostic Test: Coronary MR angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years 1 or more coronary stenoses in the major coronary artery with a vessel diameter ≥ 2mm on coronary MR angiogram Patient who were planned to undergo invasive coronary angiography and fractional flow reserve Exclusion Criteria: clinically unstable patient a history of coronary revascularization infiltrative cardiomyopathy, hypertropic cardiomyopathy, myocarditis contraindication to use of adenosine complete occlusion of target lesion

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 |
| --- |
|Diagnostic Test: Coronary MR angiography|Quantitative analysis of coronary MR angiogram|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of functionally significant coronary stenosis | fractional flow reserve < 0.8 | within 1 month |
Important Data on COVID-19 Profile in Africa

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.

Detailed Description
-----------------
In this study ,the participants will be enrolled sequentially in the COVID-19 care referral centers. The infected hospitalized patient will be identified by the physicians in hospital. After the patient has given his/her informed consent the permission will be sought from him to approach his household contacts. The household contacts will be screened, and included in the study. Patients hospitalized and positive for COVID-19 by PCR and their household contacts of all ages and gender (40% minimum of female), will be enrolled upon receipt of written informed consent.

Official Title
-----------------
Important Data on COVID-19 Profile in Africa

Conditions
-----------------
Africa, Coronavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Molecular (PCR) confirmed COVID-19 patients hospitalized in referral centers, Household contacts of hospitalized COVID-19 patient, Provided signed informed consent. Exclusion Criteria: Pregnancy
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Index cases<br>Patients infected by SARS-Cov2 Polymerase Chain Reaction (PCR) and hospitalized in a referral center for COVID-19 . | |
| Households cases<br>Household contacts of SARS-Cov2 hospitalized COVID-19 patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and biological parameters of COVID-19 | Infection and disease progression - Pattern of virus transmission | 14 days | 
| SARS-CoV-2 transmissibility | proportion of household contact who will become positive for SARS-COV2 using PCR | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronavirus infection, SARS-CoV, COVID-19, Transmission, Africa
Efficacy and Safety of Sublingual Immunotherapy (SLIT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of specific sublingual immunotherapy (SLIT) with allergen extracts in patients suffering from seasonal allergic rhinitis .

Official Title
-----------------
A Multicenter Randomized DBPC Trial to Evaluate Efficacy and Safety of Sublingual Immunotherapy (SLIT) With Allergen Extracts From Pollen in Patients With Seasonal Allergic Rhinitis

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Biological: sublingual immunotherapy with allergen extract
* Biological: sublingual immunotherapy with placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive history of allergen specific seasonal allergic rhinitis Positive screening skin prick test (wheal diameter > 3 mm) Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication Signed and dated patient´s Informed Consent, Exclusion Criteria: Previous immunotherapy within the last 3 years, Simultaneous participation in other clinical trials, Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), Auto-immune disorders, Severe chronic inflammatory diseases, Malignancy, Alcohol abuse, Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sublingual application of allergen extract<br> | Biological: sublingual immunotherapy with allergen extract<br>* sublingual application<br>|
| Placebo Comparator: sublingual application of placebo<br> | Biological: sublingual immunotherapy with placebo<br>* sublingual application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom and medication score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the treatment |  | 1 year | 
| Documentation of adverse events |  | 1 year | 
| Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) |  | 1 year | 
| Clinical global improvement |  | 1 year |
Patient Outcomes in Simulation Education (POISE) Intravenous (IV) and Lumbar Puncture (LP) Multi-institution Protocol

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the clinical efficacy of multimedia audiovisual training to hands on practice till perfect training for pediatric and emergency medicine residents' procedural skills. This initial study will explore the success rates on infant lumbar puncture and child intravenous access skills in post-graduate year one pediatric residents.

Official Title
-----------------
Patient Outcomes in Simulation Education (POISE) Intravenous (IV) and Lumbar Puncture (LP) Multi-institution Protocol

Conditions
-----------------
Infant Lumbar Puncture

Intervention / Treatment
-----------------
* Other: Simulation-based mastery learning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric interns at POISE network hospitals
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LP mastery learning group<br> | Other: Simulation-based mastery learning<br>* Hands-on coached deliberate practice on a simulator. Training until mastery achieved.<br>|
| Active Comparator: IV mastery learning group<br> | Other: Simulation-based mastery learning<br>* Hands-on coached deliberate practice on a simulator. Training until mastery achieved.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical success with lumbar puncture (LP) procedures | Online performance form | Up to one year | 
| Rate of clinical success with intravenous (IV) procedures | Online performance form | Up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simulation education, intravenous line
Pharmacogenomics and Effective Treatment With Clopidogrel

Study Overview
=================
Brief Summary
-----------------
The aim of this biospecimen repository is to evaluate an individual's genotype, identify the variances, and understand how they relate to treatment with clopidogrel.

Detailed Description
-----------------
The objective of this project is to distinguish genetic profiles that will assist a practitioner in determining the right dose or alternate medication for the patient. In partnership with the genetics team of the Avera Institute for Human Genetics and physicians with the Avera Heart Hospital of South Dakota and North Central Heart Institute, the research team will perform genetic analysis to identify genetic variances.

Official Title
-----------------
Can Pharmacogenomic Testing Improve Response and Avoid Adverse Effects With Clopidogrel Therapy? A Biospecimen Bank for Genetic and Genomic Investigation of Clopidogrel.

Conditions
-----------------
Pharmacogenomics and Cardiovascular Events

Intervention / Treatment
-----------------
* Genetic: Pharmacogenomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently taking or prescribed Clopidogrel or under consideration Acute/interventionPatients of the Avera Heart Hospital Cardiology clinic patients with the Avera Heart Hospital and North Central Heart Institute Exclusion Criteria: Unable to provide 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clopidogrel<br>Patients taking or prescribed clopidogrel or under consideration Utilizing pharmacogenomics to determine the most effective treatment | Genetic: Pharmacogenomics<br>* Utilizing pharmacogenomics to determine the most effective treatment<br>* Other names: Plavix;|

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
-----------------
Pharmacogenomics, Pharmacogenetics, Clopidogrel, Plavix
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males

Study Overview
=================
Brief Summary
-----------------
The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.

Official Title
-----------------
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration

Conditions
-----------------
Hypogonadism, Male

Intervention / Treatment
-----------------
* Drug: GnRH antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males Exclusion Criteria: use of anabolic steroids, use of narcotics,

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Testosterone<br>A Gonadotropin releasing hormone agonist (GnRH-agonist) is administered to lower the testosterone to castration levels. After four weeks testosterone undecanoate is administered to increase the testosterone to normal levels. | Drug: GnRH antagonist<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein biomarkers | Finding new protein biomarkers related to testosterone response | 48 months |