linjc16/ctgov huggingface dataset:
A Study to Evaluate the Safety Profile of an e-Vapour Product

Study Overview
=================
Brief Summary
-----------------
Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes or electronic nicotine delivery devices/systems. These may look like conventional cigarettes but do not contain tobacco. The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours. This trial is to evaluate the safety of an e-vapour product.

Official Title
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A Randomised, Parallel Group, Multi-centre Study to Evaluate the Safety Profile of the ITG EVP G1 Product

Conditions
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Healthy Volunteers

Intervention / Treatment
-----------------
* Other: E-vapour product
* Other: Conventional cigarette


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) of 18-35kg/m2 Subjects must be established smokers Subjects must have smoked five to 30 cigarettes per day for at least one year Exclusion Criteria: Subjects who have used nicotine replacement therapy within 14 days of the screening Subjects who have donated blood within 12 months preceding study Subjects with relevant illness history Subjects positive for hepatitis or Human Immunodeficiency Virus (HIV) Subjects with history of drug or alcohol abuse Subjects with lung function test or vital signs considered unsuitable Subjects who are trying to stop smoking Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e-vapour product (EVP)<br>Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP). | Other: E-vapour product<br>* Smokers of conventional cigarettes who switch to use an e-vapour product.<br>|
| Active Comparator: Conventional cigarette (CC)<br>Subjects who continue smoking their usual conventional cigarette (CC) brand. | Other: Conventional cigarette<br>* Smokers of conventional cigarettes who continue smoking conventional cigarettes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Frequency of adverse events | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled Carbon Monoxide | Level of exhaled carbon monoxide at Week 12 | 12 weeks |
Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol

Study Overview
=================
Brief Summary
-----------------
The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).

Detailed Description
-----------------
In this study we will describe habits of medical staff in prescription of growth factors or antibiotic prophylaxis ratio of patients treated by growth factors in primary or secondary prophylaxis ratio of patients treated in primary prophylaxis who present a febrile neutropenia ratio of patients who need to be hospitalized and the duration of those hospitalizations. causes of lateness, of decreasing, and of stop of chemotherapy antibiotic and growth factors prophylaxis tolerance .

Official Title
-----------------
Hematologic Toxicity Observation of the TPF Medical Protocol. Description of the Impact of Febrile Neutropenia in Patients Who Receive the Chemotherapy of the TPF Medical Protocol in Head and Neck Cell Carcinoma

Conditions
-----------------
Squamous Cell Head and Neck Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with histologically proved head and neck squamous cell carcinoma age: more than 18 patients who are beginning a chemotherapy (docetaxel+cisplatin+ 5FU) patients must have been informed of automatic data processing concerning them. Exclusion Criteria: previous chemotherapy for the head and neck squamous cell carcinoma previous chemotherapy for an other cancer in the two years before intercurrent illness that could significantly interfere with chemotherapy such as HIV infection, infection or active febrile illness, a chronic intestinal disease

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 |
| --- | --- | --- |
| biologic blood counts | evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis.. | blood test before every chemotherapy up to 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
effect of febrile neutropenia resulting chemotherapy by TPF
Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

Study Overview
=================
Brief Summary
-----------------
The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.

Detailed Description
-----------------
Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.

Official Title
-----------------
Human Factors Validation Study of Artificial Intelligence Ultrasound Navigation Software for Cardiac Imaging

Conditions
-----------------
Cardiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities. Have the capacity to understand study risks and consent to be in the study Be available and willing to participate in the study Not be employed by the Sponsor or another medical device or pharmaceutical company Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of UltraSight AI guidance software | Demonstrate that the Product can be used by the intended users by a questionnaire that is filled by an observation moderator which will assess the ease of use and user satisfaction | 10 days |
Experimental and Clinical Studies of Retinal Stimulation

Study Overview
=================
Brief Summary
-----------------
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.

Detailed Description
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The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.

Official Title
-----------------
Experimental and Clinical Studies of Retinal Stimulation

Conditions
-----------------
Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Device: New visual processing unit (VPU) with asymmetric waveforms
* Device: New VPU with bipolar stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be implanted with an Argus II Retinal Prosthesis system. Have 5 or more electrodes that create a perception with stimulation. Must be willing and able to comply with the protocol testing requirements. Exclusion Criteria: Subjects participating in another investigatory drug or device study Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 89 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retinal stimulation<br>Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus. | Device: New visual processing unit (VPU) with asymmetric waveforms<br>* A VPU will apply asymmetric and symmetric stimulation pulses.<br>Device: New VPU with bipolar stimulation<br>* A VPU will apply bipolar stimulus pulses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in stimulus thresholds | Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude). | Baseline, 8 hours | 
| Change in shape perception | As measured by elongation ratio. The elongation ratio is the ratio of major axis length to minor axis length of an ellipse. Subjects will draw shapes on a touch screen and these shapes will be fit to an ellipse. | Baseline, 8 hours |
Oxytocin in Spectrum Autism Disorders

Study Overview
=================
Brief Summary
-----------------
Observe effects of oxytocin on individuals with autism spectrum disorder

Detailed Description
-----------------
To observe the effects of oxytocin on individuals with autism spectrum disorder according to gender, in facial recognition and eye tracking tests. The investigators will apply the nepsy and eye tracking tests before and 45 minutes after the puff with oxytocin or placebo at the dose of 0.4 IU / kg / dose maximum of 24 IU. The next week the volunteer will return and will do the same procedure because whoever took the placebo would take oxytocin and vice versa. Is a randomized, double-blind, placebo-controlled clinical trial.

Official Title
-----------------
Oxytocin in Individuals With Spectrum Autism Disorders

Conditions
-----------------
Autistic Disorder

Intervention / Treatment
-----------------
* Drug: Oxytocin
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Diagnosis of ASD by DSMV CARS> 30 age between 3 and 16 years stable (3 months with medication maintained or without medication) Exclusion Criteria:- pregnant women, infants and participation in another research project of pharmacological or behavioral intervention in progress Use of pituitary hormones, cortisol, androgens and estrogens. heart problems: recent AMI, heart failure. respiratory problems: pneumonia, respiratory failure, decompensated asthma, acute bronchitis.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 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: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxytocin spray<br>oxytocin nose spray dose 0,4IU/kg, once unique dose | Drug: Oxytocin<br>* Single dose oxytocin 45 minutes before the test<br>* Other names: syntocinon;|
| Placebo Comparator: placebo<br>saline nose spray, 0,9 %, once unique dose | Other: placebo<br>* saline solution 0,9% spray nasal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye tracking | Eye tracking program | on average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nepsy | face recognize | on average of 1 year |
The Role of Serum Leptin Levels in Multiple Sclerosis Disease Activity While on Interferon Beta 1a (Rebif) Treatment

Study Overview
=================
Brief Summary
-----------------
To determine a correlation between serum leptin levels, nitric oxide preceding a relapse and change in leptin and nitric oxide levels during exacerbation in relapsing remitting multiple sclerosis patients.

Detailed Description
-----------------
This is an observational pilot study in patients with definitive relapsing-remitting multiple sclerosis to determine whether there is a correlation in serum leptin levels and serum nitric oxide levels during a clinically observed increase in disease activity. Each subject will followed for 12 months while taking interferon beta-1a subcutaneous injections 3 times a week.

Official Title
-----------------
The Role of Leptin Levels in Multiple Sclerosis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of multiple sclerosis per update of McDonald criteria Initiating treatment with interferon beta 1a subcutaneous injection with minimal dosing of 22mcg. 18-60 years of age. Women who are not pregnant or breast feeding, and who do not intend to become pregnant. Stable dose of concomitant medications for 30 days prior to baseline. Efforts should be made to maintain steady doses of concomitant medications for the duration of the study. Exclusion Criteria: Treatment on other interferon preparations, glatiramer acetate, in last 30 days or 6 months on Natalizumab, mitoxantrone, cyclosporine or other immunomodulators as determined by the PI. Treatment with any other investigational treatments within the past year or treatment with any investigational treatments for multiple sclerosis within the last year. Any progressive form of MS. Known Hypersensitivity to interferon beta 1a. Inability to administer subcutaneous injections Inability to undergo laboratory evaluation. Seropositivity for HIV (by medical history) Diabetes Mellitus Tyle I or II (by medical history) Hepatitis B or C (by medical history) Uncontrolled psychiatric disorder. Any unstable illness that the investigator's opinion precludes participation in this study. Inability to maintain compliance with study protocol. Implanted devices or metal which would contraindicate MRI. Clinically significant abnormalities in CBC or CMP MMSE <25

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting leptin and nitric oxide testing |  | monthly, for 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS, Serum Leptin Levels during relapse, Multiple sclerosis, relapse
Effect of LPEC Compared With a Sham Procedure in the General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia

Official Title
-----------------
Effect of LPEC Compared With a Sham Procedure in the General Anesthesia

Conditions
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Intubation;Difficult

Intervention / Treatment
-----------------
* Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubation Exclusion Criteria: ENT neoplasia

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LPEC<br> | Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia<br>* Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition<br>|
| Sham Comparator: Sham procedure<br> | Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia<br>* Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cormack score | from 0 to 4 | During laryngoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation |  | During laryngoscopy |
Bandage Contact Lens Application for the Management of Corneal Abrasion

Study Overview
=================
Brief Summary
-----------------
The researchers are trying to understand if the application of a bandage contact lens results in better relief than usual treatment for a corneal abrasion.

Official Title
-----------------
Bandage Contact Lens Application for the Management of Corneal Abrasion in the Emergency Department

Conditions
-----------------
Corneal Abrasion

Intervention / Treatment
-----------------
* Device: Air Optix contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Superficial Corneal Abrasion Exclusion Criteria: Incarceration Pregnancy Inability to Provide Informed Consent Infectious keratitis Retained foreign bodies in the eye Active infection involving the orbit or periorbital region Patients who are not able to or who are deemed unlikely to follow-up with ophthalmology A history or recent contact lens wear A lack of trauma or an unclear history of trauma as the inciting cause of the abrasion Allergy to the antimicrobial solution (POLYTRIM) Women who are currently breastfeeding Chronic eye drop use A history of eye surgery other than cataract surgery (greater than 6 months prior to abrasion) Diabetes (Patients with even mild diabetic neuropathy can have decreased pain sensation and also delayed corneal epithelial healing) Any eye condition that may be deemed to interfere with the conduct of the protocol or outcome measurement.

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: Bandage Contact Lens (BCL) group<br>Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have a bandage contact lens soaked in antibiotic solution placed in the affected eye | Device: Air Optix contact lens<br>* Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage<br>|
| No Intervention: Usual Care Group<br>Subjects diagnosed with superficial corneal abrasion in the Emergency Department will have usual care provided in the Emergency Department | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score | Measured on scale of 0 being no pain, 5 being moderate pain and 10 being worst pain possible | Baseline, approx. 12-24 hours, approx. 36-48 hours, approx. 1 day, 3 days, and/or 5 days post-discharge |
Feasibility and Effects of an Enhanced Recovery vs Conventional Care After Emergency Colon Surgery for Patients With Left Colon Perforation.

Study Overview
=================
Brief Summary
-----------------
A study was designed with a prospective cohort of all patients undergoing urgent surgery for left colon perforation between March 2014 and June 2017 who were treated according to a specific ERAS programme (ERAS group/29 patients). This group was compared with a historic case-matched control group with conventional care (CC group/21 patients). The main endpoints were postoperative 30-day morbidity, length of postoperative hospital stay, rate of readmission within 30 days, and mortality. The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS) between 6-11 points.

Official Title
-----------------
Feasibility and Effects of an Enhanced Recovery vs Conventional Care After Emergency Colon Surgery for Patients With Left Colon Perforation.

Conditions
-----------------
Colon Perforation

Intervention / Treatment
-----------------
* Procedure: ERAS care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were patients over 18 years old with a low-moderate risk of mortality according to a Peritonitis Severity Score (PSS), between 6-11 points. Exclusion Criteria: The exclusion criteria were patients under 18 years old and patients with a high risk of mortality according to a PSS equal to or greater than 12 points.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERAS programme<br>Patients who have been treated under an ERAS programm | Procedure: ERAS care<br>* ERAS PROTOCOL<br>|
| conventional care<br>Patients who have been treated under an conventional care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of items completed of ERAS protocol | to analyze the applicability of a specific ERAS protocol in the management of patients with left colon perforation requiring emergency colon surgery, it will be analyzed the number of items completed of ERAS protocol (YES/NO) | 1-month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COLON PERFORATION SURGERY