linjc16/ctgov huggingface dataset:
Heated Circuit on Sore Throat

Study Overview
=================
Brief Summary
-----------------
This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing endotracheal intubation for general anesthesia.

Official Title
-----------------
Heated Breathing Circuit on Postoperative Sore Throat After Endobronchial Tube Insertion

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Device: Heated circuit on
* Device: Heated circuit off


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Patients scheduled for general anesthesia with endotracheal intubation Exclusion Criteria: Difficult airway Mallampatti scores greater than 2 Recent sore throat Cervical spine disease Recent upper respiratory infection Recent analgesics History of head and neck surgery Friable teeth Multiple intubation attempts

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Device: Heated circuit off<br>* Heated circuit will be turned off.<br>|
| Experimental: Heat<br> | Device: Heated circuit on<br>* Heated circuit will be turned on.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative sore throat for postoperative 24 hour |  | At 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative sore throat |  | At 2, 4, and 24 hour | 
| Number of participants with postoperative hoarseness |  | At 2, 4, and 24 hour | 
| Wound pain scores | Visual analogue scales will be used (10: most imaginable pain, 0: no pain). | At 2, 4, and 24 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharyngitis, intubation, heat
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.

Conditions
-----------------
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic

Intervention / Treatment
-----------------
* Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution
* Drug: olopatadine hydrochloride 0.1% ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of seasonal allergic conjunctivitis Exclusion Criteria: Ocular infection or history of ocular herpes infection History of retinal detachment or diabetic retinopathy Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines Ocular surgery within 8 weeks

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: 1<br>olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution | Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution<br>* One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.<br>|
| Active Comparator: 2<br>olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution | Drug: olopatadine hydrochloride 0.1% ophthalmic solution<br>* One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.<br>* Other names: Patanol®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching |  | Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperemia |  | Day 21 | 
| Chemosis |  | Day 21 | 
| Ocular mucous discharge |  | Day 21 |
INVSENSOR00011 Clinical Performance Study

Study Overview
=================
Brief Summary
-----------------
This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Official Title
-----------------
INVSENSOR00011 Clinical Performance Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: INVSENSOR00011


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old Physical status of ASA I or II Must be able to read and communicate in English Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement Passed health assessment screening Exclusion Criteria: Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study Inability to tolerate sitting still or minimal movement for at least 30 minutes Nursing female volunteers Excluded at the Principal Investigator's discretion Refusal to take pregnancy test (for female subjects) Positive pregnancy tests for female subjects of child bearing potential. Refusal to shave hair off areas where sensors will be applied (male subjects)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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: INVSENSOR00011 Test group<br>The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. | Device: INVSENSOR00011<br>* INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of INVSENSOR00011's Posture Change Detection | Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection) | Approximately 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Rate Detection | When INVSENSOR00011 respiratory rate (RR) readings are available, it will be compared against reference respiratory rate by computing mean and standard deviation of the differences. | Approximately 20 minutes |
Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor

Study Overview
=================
Brief Summary
-----------------
Foot disorders have been recognized as being linked to chronic low back pain

Detailed Description
-----------------
Foot disorders have been recognized as being linked to chronic low back pain (CLBP), To improve knowledge of the relationship between the limitation of the movement range of hallux (HROML) is important about it can affect the back biomechanical . The aim of this research is to investigate if the HROML may appear as a risk factor of CLBP HROML affect the foot position, and consecuently may induce to alter as compensatory mechanism the normal biomechanical of the leg, hip and back.

Official Title
-----------------
Foot Posture Index Pronated, Hallux Limitus Connection and Chronic Low Back Pain Gait Parametrers With Optogait Sensor

Conditions
-----------------
Hallux Limitus, Movement, Abnormal, Back Pain Lower Back Chronic

Intervention / Treatment
-----------------
* Diagnostic Test: Case control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males and females between 18 to 65 years old Hallux limitus in one or two feet - Exclusion Criteria: serious illness, current participation in another research study pregnancy previus foot or back surgery -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Low back pain<br>Patients with low back pain | Diagnostic Test: Case control<br>* Is a case-control research<br>|
| No low back pain<br>No low back pain patients | Diagnostic Test: Case control<br>* Is a case-control research<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hallux dorsal movement range degrees | Goniometer to examinate the range of hallux dorsal movement | A day, the inclusion day in the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain | questionnary oswestry disability index | a day, the inclusion day in the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
foot, hallux, limitus, back
Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Detailed Description
-----------------
The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Official Title
-----------------
Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence

Conditions
-----------------
Stress Incontinence, Female

Intervention / Treatment
-----------------
* Device: laser therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Light or moderate stress incontinence mixed urine incontinence with predominance of the stress component written informed consent Exclusion Criteria: Pregnancy patients treated radiotherapy in the small basin connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome) patient with or after malignant disease of the uterus, ovaries, vagina and vulva former surgery due to stress incontinence (except for the patients who had a TVT insert with removal of the TVT) Descensus genitalis> POPQ Stage 1 former surgery due to a genital lowering with vaginal netting

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

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

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: laser therapy<br>Erbium-laser therapy will be applied | Device: laser therapy<br>* Transvaginal erbium-laser treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life will be access via ICIQ-SF questionaire | 6 month |
Safety Study of the Rapid System for Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
This is a safety study of the Rapid System for acute ischemic stroke.

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Device: Rapid System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 to <85 years old Pre stroke modified Rankin Scale (mRS) of ≤2 A signed informed consent by patient or a legally acceptable representative Exclusion Criteria: Pre-stroke life expectancy of less than 6 months Current participation in another investigational drug or device study Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Stroke patients<br> | Device: Rapid System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with Adverse Device Effects (ADEs) Percentage of participants with Adverse Device Effects (ADEs)Percentage |  | 12 patients |
Compuflo® vs Conventional Training With an Epidural Simulator

Study Overview
=================
Brief Summary
-----------------
Epidural block is one of the most difficult skills that can be mastered by trainees probably due to the difficulty of recognizing the ligamentum flavum (LF) during the loss of resistance technique (LORT).The CompuFlo® Instrument can measure the pressure of human tissues in real-time at the orifice of a needle and it has been successfully used in clinical practice to identify the epidural space.The aim of this study was to evaluate whether Compuflo® may help trainees to identify the ligamentum flavum using a realistic Epidural Simulator

Detailed Description
-----------------
The investigators enrolled 60 trainees who have never performed an epidural block. After having had a standardized learning module on epidural anatomy and technique, each trainee practiced the epidural and the Compuflo®-assisted LORT on the simulator for a maximum of 5 attemps. Trainees were asked to stop the needle entrance whenever they felt a sensation of an increase of resistance due to the penetration of the needle in the LF. The correct position of the needle was verified by an expert instructor. The number of attempts was noted. The power analysis required a sample size of 60 observations to set 80% test power and a 95% significance. Unpaired T-test was used to evaluate the differences in the number of epidural attempts. A logistic regression model was used to correlate the success at the first attempt ratio and the technique used.

Official Title
-----------------
Compuflo® Assisted Training vs Conventional Training for the Identification of the Ligamentum Flavum With an Epidural Simulator

Conditions
-----------------
Epidural Simulator

Intervention / Treatment
-----------------
* Device: Compuflo assited procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First year trainees in anesthesia who never have performed an epidural block Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 26 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Compuflo assited procedure|number of needle entry required to identify the ligamentum flavum|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epidural attempts | number of attempts to correctly identify the epidural space | 10 minutes |
Tolerability and Safety of An Infant Formula

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.

Official Title
-----------------
A Multicenter, Single-blind, Randomized, Phase II Study of the Tolerability and Safety of NPS-202 in Infants With Clinically Diagnosed Cow's Milk Allergy

Conditions
-----------------
Milk Hypersensitivity

Intervention / Treatment
-----------------
* Other: Nutramigen Lipil (Infant formula)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinically diagnosed CMA </= 12 weeks at time of study entry full-term infant must be willing to use provided formula as sole source of nutrition other than CMA, infant must be otherwise healthy Exclusion Criteria: underlying or confounding gastrointestinal abnormalities infants born from an addictive situation, HIV positive if parent/guardian is considered likely to be non-compliant with the protocol requirements

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Weeks

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extensively hydrolyzed infant formula<br>New extensively hydrolyzed formula, NPS-202 | Other: Nutramigen Lipil (Infant formula)<br> <br> * Other names: Extensively hydrolyed infant formula (Nutramigen Lipil);|
| Active Comparator: Infant formula - Extensively hydrolyzed Nutramigen Lipil<br>Currently marketed extensively hydrolyzed formula (Nutramigen Lipil) | Other: Nutramigen Lipil (Infant formula)<br> <br> * Other names: Extensively hydrolyed infant formula (Nutramigen Lipil);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant reactivity to an extensively hydrolyzed infant formula |  | 29 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant formula, cow's milk allergy
Bioequivalence Study On Pediatric Appropriate Formulation

Study Overview
=================
Brief Summary
-----------------
To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.

Detailed Description
-----------------
Determination of Bioequivalence

Official Title
-----------------
An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A Pediatric Appropriate Formulation To A 10 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Lipitor
* Drug: Atorvastatin pediatric formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects Mass Index (BMI) of approximately 18 to 30 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption A positive urine drug screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reference<br>Commercial 10 mg Lipitor formulation tablet | Drug: Lipitor<br>* A single dose of 10 mg Lipitor tablet<br>* Other names: Atorvastatin;|
| Other: Test<br>Atorvastatin pediatric formulation | Drug: Atorvastatin pediatric formulation<br>* A single dose of 10 mg atorvastatin pediatric formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data. |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin. |  | 5 months | 

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