linjc16/ctgov huggingface dataset:
An Evaluation of the FreeStyle Flash Glucose Monitoring System

Study Overview
=================
Brief Summary
-----------------
The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system in children will be evaluated by questionnaires, pictures of the insertion site and comparison of the glucose results with capillary blood glucose determinations.

Official Title
-----------------
An Evaluation of the Usability, Skin Reactions and Accuracy of the FreeStyle Libre Flash Glucose Monitoring System

Conditions
-----------------
Flash Glucose Monitoring, Skin Reactions

Intervention / Treatment
-----------------
* Device: FreeStyle Libre Flash Glucose Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetes mellitus being followed in the Pediatric Diabetes Unit of the Jessa Ziekenhuis Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FreeStyle Libre Flash Glucose Monitoring|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the FreeStyle glucose monitoring systeem | The usability will be evaluated by a short questionnaire. | 0.5 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin reactions to the sensor : e.g. allergic reaction, red mark, blister | The skin reactions will be evaluated by a questionnaire and a picture will be taken when skin reactions are present. | 0.5 year follow-up | 
| Accuracy of the FreeStyle Libre glucose monitoring system |  | 0.5 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flash glucose monitoring, skin reactions, usability, accuracy
Microbes and Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The investigators will study people who are obese and will be treated by bariatric surgery. The investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract.

Official Title
-----------------
Effects of Bariatric Surgery on the Gastro-intestinal Microflora

Conditions
-----------------
Obesity, Diabetes, Periodontal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-65 Will undergo bariatric surgery for treatment of obesity in Syracuse NY Willingness to participate Exclusion Criteria: Any previous gastrointestinal surgery Use of antibiotics in the previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| Changes in microflora after bariatric surgery | Specific differences were measured in oral and intestinal bacteria immediately after surgery. | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Diabetes, Periodontal disease
Evaluation of Biological Response to SARS-COV2 (COVID-19) in Patients With Pre-existing Neurological Disease or Newly Neurological Symptoms (BIO-COCO-NEUROSCIENCES)

Study Overview
=================
Brief Summary
-----------------
Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.

Official Title
-----------------
Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19

Conditions
-----------------
Covid19, Neurologic Manifestations, Psychiatric Manifestations

Intervention / Treatment
-----------------
* Other: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Age over 18 yo Patient having presented or presenting a Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period And patient with: a neurological or psychiatric manifestation de novo during or after the Covid-19 infection and/or either a chronic neurological or psychiatric pathology

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Covid-19 infection<br>Covid-19 infection defined by a positive PCR or a typical chest scanner of Covid-19 infection or a positive serology or a typical clinical picture in a pandemic period | Other: blood sample<br>* blood sample for serum (serology, biomarkers) and DNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients | dosage of seric markers (anti-SARS-CoV2 IgG) or genetic markers (genetic variants) observed during COVID 19 infection in patients | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum neurofilaments | Neurodegenerative markers (e.g., neurofilaments) associated with a neurological or psychiatric manifestation of Covid-19 infection | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, neurological disease, Multiple Sclerosis, psychiatric disease, biology,, biocollection,, biomarkers,, DNA,, Parkinson's Disease
Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries

Study Overview
=================
Brief Summary
-----------------
Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total occlusions in native femoropopliteal arteries.

Official Title
-----------------
Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries

Conditions
-----------------
Chronic Total Occlusion

Intervention / Treatment
-----------------
* Device: OffRoad Re-entry Catheter System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Claudication or critical limb ischemia (Rutherford Category 2-5) Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed) lesion in native femoropopliteal artery Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm Minimum reference vessel diameter is 4 mm Exclusion Criteria: Contraindication to an endovascular procedure Previous stent placement in the target vessel Prior surgery of the superficial femoral artery (SFA) in the target limb to treat atherosclerotic disease Platelet count <150,000 mm3 or >600,000 mm3 Renal insufficiency with a serum creatinine >2.3 mg/dl History of major amputation (ankle level or above) in the same limb as the target lesion Current participation in another drug or device clinical 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OffRoad Re-entry catheter<br>Participants treated with OffRoad Re-entry Catheter System | Device: OffRoad Re-entry Catheter System<br>* Facilitate the placement and positioning of guidewires within the peripheral vasculature.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Rate of Major Adverse Events | Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above). Events are based on data adjudicated by a Clinical Event Committee. | 30 days | 
| Effectiveness (On the Day of Procedure) | Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO) | Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body |
Measurement of Cut-off Perfusion Index Value in Infraclavicular Blocks

Study Overview
=================
Brief Summary
-----------------
To investigate the value of the cut-off perfusion index showing that the block is successful in infraclavicular blocks performed under ultrasound guidance.

Detailed Description
-----------------
In upper extremity procedures, ultrasound (US) guided infraclavicular block is a frequently used approach. Today, the frequency of studies on the perfusion index (PI), which can be used as a criterion in the evaluation of block success, is increasing. The aim of this study is to evaluate the success and effectiveness of infraclavicular approach block with perfusion index using ROC (Receiver Operating Characteristic) curves.

Official Title
-----------------
To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance.

Conditions
-----------------
Upper Extremity Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 PATIENTS PATIENTS BETWEEN 18-65 YEARS PATIENTS WITH INFRACLAVICULAR BLOCK Exclusion Criteria: ASA3-4 PATIENTS PATIENTS UNDER THE AGE OF 18, PATIENTS OVER 65 PATIENTS WHO DO NOT WANT TO BE INCLUDED IN THE STUDY PATIENTS WITH CONTRAINDICATION TO INFRACLAVICULAR BLOCK PATIENTS WITHOUT COOPERATION PATIENTS WITH DIABETES MELLITUS THOSE WHO HAVE PERIPHERAL ARTERY DISEASE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance | To measure perfusion index values in patients aged 18-65 years who underwent upper extremity surgery | Perfusion index, pulse and blood pressure will be measured 5-10-20 minutes after the block is made. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infraclavicular block, perfusion index
Study of Participants With Crohn's Disease and Ulcerative Colitis in Eastern Europe, Middle East, and North Africa (P08166)

Study Overview
=================
Brief Summary
-----------------
This study is being done to assess the clinical course and treatment options for Crohn's Disease (CD) and ulcerative colitis (UC) in the populations of Eastern Europe, Middle East, and North Africa.

Official Title
-----------------
Cross-sectional Study of Inflammatory Bowel Disease Severity and Treatment Patterns in Eastern Europe, Middle East, and North Africa. (P08166)

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: No intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Crohn's disease or ulcerative colitis.

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 |
| --- | --- |
| CD and UC participants<br>All participants with CD or UC visiting their physician over a period of one year, newly and already diagnosed, regardless of treatment pattern. | Other: No intervention.<br>* There is no study intervention. Participants will be treated locally per site standards.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with Crohn's Disease (CD) or ulcerative colitis (UC) who visit the participating sites. |  | 1 Year | 
| The number of participants with different degrees of CD and UC severity. |  | 1 Year | 
| Use rates of classes of drug therapy. |  | 1 Year | 
| Number and types of surgical interventions. |  | 1 Year | 
| Outcomes of surgical intervention. |  | 1 Year |
NicVAX/Placebo as an Aid for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

Official Title
-----------------
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation

Conditions
-----------------
Smoking Cessation, Smoking, Tobacco Cessation

Intervention / Treatment
-----------------
* Biological: NicVAX vaccine
* Biological: Placebo vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking. Smokers who are in good general health. Exclusion Criteria: Prior exposure to NicVAX or any other nicotine vaccine. Use of systemic steroids. Cancer or cancer treatment in last 5 years. HIV infection. History of drug or alcohol abuse or dependence within 12 months. Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease. Inability to fulfill all visits for approximately 52 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Placebo Comparator: Placebo vaccine<br> | Biological: Placebo vaccine<br>* Placebo vaccine given 6 times over 6 months<br>|
| Experimental: NicVAX vaccine<br> | Biological: NicVAX vaccine<br>* NicVAX vaccine given 6 times over 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate NicVAX as an aid to smoking cessation for long term abstinence. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate abstinence rates at multiple intervals |  | multiple time points | 
| Evaluate safety and immunogenicity |  | mulitple time points | 
| Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence. |  | multiple time points | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, NicVAX, smoking vaccine, smoking abstinence, smoking, tobacco cessation
Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction

Study Overview
=================
Brief Summary
-----------------
Currently there are few therapeutic options for the treatment of lid retraction secondary to thyroid orbitopathy (TO) during the active stages of the disease. BoTox injection is capable of creating a ptosis, that in the setting of TO can return the upper lid to a more physiologic position, thus improving cosmesis, corneal lubrication and potentially quiescent stage lid position. This investigation aims to examine the properties of this relationship.

Conditions
-----------------
Graves Ophthalmopathy

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Drug: Saline injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Active stage thyroid orbitopathy, as determined by symptom onset of under 6 months. Upper eyelid retraction of 1mm or greater. Complaining of either significant ocular symptoms (despite appropriate use of ocular lubricants), or bothered by the cosmetic deformity associated with the eyelid retraction. Exclusion Criteria: Less than 18 years of age Age over 65 years Pregnant or nursing Known peripheral neuropathy or neuromuscular junction disorder Demonstrated allergy to BoTox Current infection over the injection site Are currently taking any of the following medications: aminoglycosides, penicillamine, quinine, and calcium channel blockers. Previous or concurrent prednisone therapy Undergone previous upper eyelid surgery Severe vision threatening TO

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BoTox Treatment<br>Subjects receive BoTox injection to levator complex | Drug: Botulinum Toxin Type A<br>* 2-12 units in weekly 2u doses to effect<br>* Other names: BoTox;|
| Placebo Comparator: Saline injection<br>Saline injection to levator complex | Drug: Saline injection<br>* Injection of 0.4cc 0.9% normal saline<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in upper lid retraction (in mm) |  | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective improvement in lid retraction related dry eye symptoms | ocular surface disease index score | 4 months | 
| Subjective improvement in lid retraction related cosmesis | Graves Orbitopathy quality of life score | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eyelid retraction, Botulinum Toxins
The Natural History of Parkinson's Disease-associated Spinal Disorders

Study Overview
=================
Brief Summary
-----------------
This is a prospective single-institution longitudinal study to access quality of life and serial imaging and biodynamic testing to assess spinal disorders associated with Parkinson's disease patients.

Detailed Description
-----------------
This is a prospective single-institution longitudinal study to access quality of life with PROMIS testing, ODI, NDI, VAS and short form 36 health physical component score. The study will also include serial radiographic assessments and biodynamic force plate and hand dynamometer testing. This study will follow for five years post-consent.

Official Title
-----------------
The Natural History of Parkinson's Disease-associated Spinal Disorders

Conditions
-----------------
Parkinson Disease, Idiopathic Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75 Exclusion Criteria: Prior spinal fusion Diagnosis of ankylosing spondylitis, diffuse idiopathic spinal hyperostosis (DISH), or other systemic condition that affects spinal function Inability to consent Current incarceration Presence of other medical condition or neurologic condition that would hinder ability to perform biodynamic testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of spine disorders in idiopathic Parkinson's disease | Natural history of spine disorders in idiopathic Parkinson's disease | Consent to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical impact of Parkinson's related spinal disorders | Clinical impact of Parkinson's related spinal disorders assessed by radiographic imaging and biodynamic testing | Consent to five years | 
| Factors associated with the development and progression of Parkinson's related spinal disorders | Factors associated with the development and progression of Parkinson's related spinal disorders by assessing patients reported outcomes | consent to five years | 
| Parameters for optimal management | Parameters for optimal management will be assessed by imaging and patient's medical records | consent to five years |