linjc16/ctgov huggingface dataset:
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.

Official Title
-----------------
Post Marketing Surveillance in Japan on Drug Use of JARDIANCE® Tablets in Elderly Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Jardiance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with JARDIANCE® Tablets before the enrolment and start taking JARDIANCE® Tablets within 3 months after launch in Japan Exclusion criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Jardiance<br> | Drug: Jardiance<br>* Empagliflozin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Adverse Drug Reactions (ADRs) | Percentage of patients with drug related Adverse events | From first drug administration until 7 days after last drug adminstration, up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c at the Last Observation During the Observation Period | Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period | Baseline and last observation on treatment, up to week 52 | 
| Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period | Change from baseline in Fasting plasma glucose at the last observation during the observation period. | Baseline and last observation on treatment, up to week 52 |
Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay

Study Overview
=================
Brief Summary
-----------------
Purpose: to build a library of normal tear lacritin values by collecting tears from normal adult human subjects and to develop a non-invasive clinical assay for lacritin. Such an assay will provide more sensitive indicators of eye disease for clinicians and determine if a particular therapy, such as recombinant lacritin drops, is of benefit.

Official Title
-----------------
Normal Lacritin Levels in Human Tears- Development of a New Clinical Assay

Conditions
-----------------
Tear Protein Lacritin in Human Tears

Intervention / Treatment
-----------------
* Procedure: Tear Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Military health care beneficiary between the ages of 21-55. Male or female, of any race, and at least 21 years old and not older than 55 years old at the time of tear collection. Appropriately aged individuals who report that their eyes are normal and who have no active eye illness as determined by principal investigator or sub-investigator. Ability and willingness to understand and provide informed consent to participate in this study. Exclusion Criteria: Irritated eye reflected by patient statements or finding of red eye. Individuals with any infections or inflammatory ocular condition (e.g. have pink eye or uveitis). Individuals diagnosed with dry eye or other ocular surface condition, including but not restricted to neurotrophic keratitis, anterior basement membrane dystrophy, and recurrent corneal erosions. Individuals who are on any topical eye medications. Anyone who reports previous reaction or the possibility of an allergic reaction to 0.5% proparacaine.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tear Collection|The tear sample will be collected from the left eye of each subject. Subjects wearing contact lenses will be instructed to remove their lenses and wait at least 5 minutes before proceeding with the tear collection procedure. The patient will then be instructed to sit with eyes gently closed for two minutes after instilling one (1) drop of 0.5% proparacaine on the cornea and conjunctiva. Tear collection was accomplished by using a polyester fiber rod wick. This wick will be placed in contact with the tear fluid at the lower cul-de-sac for a minimum time to obtain fluid without irritating the subject's eye approx. for 3 to 5 minutes.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lacritin levels in human tears |  | 2 minutes after instilling anesthetic eyedrop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lacritin
Early Detection of Vaping-related Vascular Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how vaping affects blood vessels, in particular if early damage occurs in the lung vessels.

Official Title
-----------------
Early Detection of Vaping-related Vascular Diseases

Conditions
-----------------
Vaping, Blood Vessel Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vapers Group: Current electronic cigarette (EC) Puff Bar users defined as using EC either daily or occasionally in the past 30 days for at least 6 months, and with 5% nicotine concentration pods. Adults aged 18-40 years Healthy Group: Healthy never smokers, never vapers Adults aged 18-40 years Exclusion Criteria: Current or past smoking of tobacco cigarette (TC) or other tobacco/nicotine products (e.g., smokeless tobacco, Hookah) or marijuana will be excluded from the study. Subjects with self-reported history of chronic health problems including asthma, chronic obstructive pulmonary disease (COPD), morbid obesity (BMI>40 kg/m2), hypertension or diabetes Pregnant or breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteer Group<br>Participants who have never smoked or vaped | |
| High Frequency Vaping Group<br>Participants who vape >20 days per month. | |
| Low-Frequency Vaping Group<br>Participants who vape < 20 days per month | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway blood flow reactivity (QAW) | QAW will be measured via soluble gas uptake method | Up to 1 week | 
| Pulmonary vascular resistance (PVR) | PVR will be measured via echocardiography | Up to 4 weeks | 
| Flow-mediated vasodilation (FMD) | FMD will be measured by blood pressure cuff deflation using ultrasound | Up to 4 weeks |
Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?

Study Overview
=================
Brief Summary
-----------------
The study aims to show a difference of observation and data integration between novice and expert during anaesthetic induction, in a population of nurse anesthetists.

Official Title
-----------------
Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?

Conditions
-----------------
Nurse's Role

Intervention / Treatment
-----------------
* Behavioral: Eye-tracking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Groupe novice : nurse anesthetist students, in 1st or 2nd years at Besançon nursing school OR nurse anesthetists with less than 1 year experience at Besançon University Hospital Group expert : full-time employed nurse anesthetists, with at least 5 years experience at Besançon University Hospital Correct vision with or without correction

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novice<br> | Behavioral: Eye-tracking<br>* Visualisation of 4 photographic scenarios (surgical situations), questionnaire, eye-tracking<br>|
| Experimental: Expert<br> | Behavioral: Eye-tracking<br>* Visualisation of 4 photographic scenarios (surgical situations), questionnaire, eye-tracking<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of eye-fixations on each Region Of Interest (ROI) | Measured with the eye-tracker | Day 1 | 
| Duration of eye-fixation on each ROI | Measured with the eye-tracker | Day 1 |
Cytokine Adsorption in Sepsis and Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney injury in patients with severe sepsis/septic shock

Detailed Description
-----------------
Patient with proved severe sepsis/septic shock, treated in accordance to actual sepsis guidelines, who develope akute kidney injury (RIFLE I) or kidney failure (RIFLE F), were randomized in two groups. One group is treated with CVVHD/ local citrat anticoagulation (standart clinical practice). The other group ist treated with an additional cytokine adsorber ( 300ml CytoSorb device, 3804606CE01) CytoSorb therapy is performed for 24h, then the adsorber is changed into a new device. Cytosorb therapy is stopped, when Interleukin 6 leves drop below 1000 pg/ml in patient serum.

Official Title
-----------------
Cytokine Adsorption in Sepsis and Acute Kidney Injury

Conditions
-----------------
Renal Insufficiency or Renal Failure &or End-stage Renal Disease

Intervention / Treatment
-----------------
* Device: CytoSorb 300 ml device (3804606CE01)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe sepsis or septic shock according to ESICM guidelines not older than 24 h Exclusion Criteria: preexisting renal disease KDIGO stadium 4 and 5

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention<br>Standart CVVHD plus CytoSorb 300 ml device (3804606CE01) | Device: CytoSorb 300 ml device (3804606CE01)<br>* additional cytokine adsorber<br>|
| No Intervention: control<br>Standart CVVHD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RIFLE stadium L or E after acute kidney injury related to sepsis |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 3 months | 
| length of renal replacement therapy |  | 3 months | 
| SOFA score |  | 3 months | 
| cumulative dose of vasopressor support |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, acute kidney injury , CytoSorb
HoloSIM: Mixed Reality Medical Student Training in Complex Crisis Scenarios

Study Overview
=================
Brief Summary
-----------------
In this study, Investigators will test a mixed reality software platform to improve and help for teaching and assessment of anesthesia crisis management among medical students.

Official Title
-----------------
HoloSIM: The Way Forward in Complex Crisis Training

Conditions
-----------------
Educational Problems, Simulation of Physical Illness

Intervention / Treatment
-----------------
* Device: HoloSIM Software via Hololens 2
* Other: Training by Mannequin Based Simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: University of Toronto Medical student volunteers Exclusion Criteria: Unwilling to enter the study Deficit of vision or hearing incompatible with Microsoft Hololens 2 use
Sexes Eligible for Study
-----------------
All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training by Mixed Reality Simulation<br> | Device: HoloSIM Software via Hololens 2<br>* Medical students will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2<br>|
| Active Comparator: Training by Mannequin Based Simulation<br> | Other: Training by Mannequin Based Simulation<br>* Medical students will train a via traditional mannequin based medical crisis scenario<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaphylaxis Checklist of Core Decision Making Steps | Expert consensus based checklists of critical scenario actions on a mannequin based crisis scenario. Student scenario performance graded from 0 to 45, with higher scores representing a better performance. | one week post exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability Score | Likert scale (5 point) based assessment of software usability. Higher scores on a scale of 1 to 5 represent a better software system usability. | Immediately after exposure | 
| Learning Satisfaction Score | Likert scale (5 point) based assessment of learning satisfaction. Higher scores on a scale of 1 to 5 represent a greater degree of learning satisfaction. | Immediately after exposure | 
| Time required to complete critical crisis related tasks | Measured time until critical scenario management events occur | one week post exposure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mixed Reality
A Study Evaluating Botulinum Toxin Type A in Subjects With Postherpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
4-month study including a 30-day baseline phase

Conditions
-----------------
Postherpetic Neuralgia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postherpetic neuralgia for more than 3 months after the healing of a herpes zoster skin rash. Exclusion Criteria: Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum Toxin Type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various Quality of Life questionnaires |  |  | 
| Reduction in area of pain/allodynia |  |  |
Firefly ANKLE Sprain Study

Study Overview
=================
Brief Summary
-----------------
The device to be tested (fireflyTM) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. The device is also indicated for the treatment of oedema. In this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.

Official Title
-----------------
Firefly ANKLE Sprain Study

Conditions
-----------------
Grade I/II Ankle Sprain

Intervention / Treatment
-----------------
* Device: firefly
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and over Referred to physiotherapy for treatment of ankle sprain Clinical diagnosed ankle sprain with evidence of swelling Able to understand the Subject Information Sheet and willing to sign the written Informed Consent Form. Able and willing to follow the protocol requirements Exclusion Criteria: Has an ankle sprain grade 3 Evidence of fracture Has a pacemaker Chronic Obesity (BMI Index >40kg/m2). Pregnancy. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted Not able to fit firefly device

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: firefly<br>participants treated with firefly device | Device: firefly<br> <br> |
| Other: Control<br>Standard of care | Other: Standard of care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oedema lower leg |  | 1 week | 
| FAAM ankle function measure |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle proprioception - as assessed by the time that the participant can stand on one leg for with their eyes closed, this will be recorded and repeated three times, the average will be taken |  | 1 week | 
| VAS Pain score |  | 1 week | 
| Adverse event rate |  | 1 week |
JC-Virus (JCV) Antibody Program

Study Overview
=================
Brief Summary
-----------------
The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.

Detailed Description
-----------------
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

Official Title
-----------------
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1

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

Intervention / Treatment
-----------------
* Drug: Tysabri® (natalizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab). Key Exclusion Criteria: Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsing Multiple Sclerosis<br>Participants receiving or considering treatment with Tysabri® (natalizumab). | Drug: Tysabri® (natalizumab)<br>* Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program<br>* Other names: BG0002;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of serum anti-JC virus (JCV) antibody | Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated. | Day 1 | 
| Number of participants with a false negative test | Confirm the false negative rate for serum anti-JCV antibody [assay]. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in JCV antibody status over time |  | Every 6 months for 2 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JCV, Sample Collection, PML