linjc16/ctgov huggingface dataset:
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy

Study Overview
=================
Brief Summary
-----------------
The primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for SLITone ULTRA house dust mite mix in adult subjects with moderate to severe HDM allergic rhinitis.

Official Title
-----------------
A Dose Response Evaluation of SLITone Ultra HDM Mix Immunotherapy - The SUMMIT Trial

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

Intervention / Treatment
-----------------
* Biological: SLITone ULTRA HDM immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 or older Moderate to severe persistent HDM allergic rhinitis with or without asthma Moderate to severe HDM allergic rhinitis symptoms during a baseline period Positive skin prick test response (wheal diameter ≥ 3 mm) Positive specific IgE ≥ IgE Class 2, ≥ 0.70 kU/l) Exclusion Criteria: Previous treatment with immunotherapy with House dust mite immunotherapy Ongoing treatment with any allergen specific immunotherapy product Reduced lung function Clinical history of uncontrolled asthma Inflammatory conditions in the oral cavity with severe symptoms History of anaphylaxis with cardiorespiratory symptoms History of recurrent generalised urticaria A history of drug induced facial angioedema or hereditary angiooedema Any clinically relevant chronic disease (≥3 months duration) Systemic disease affecting the immune system Immunosuppressive treatment Currently treated with tricyclic antidepressants; catecholamine-Methyltransferase inhibitors and mono amine oxidase inhibitors

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 |
| --- | --- |
| Active Comparator: SLITone ULTRA low dose<br>SLITone ULTRA HDM immunotherapy | Biological: SLITone ULTRA HDM immunotherapy<br> <br> |
| Active Comparator: SLITone ULTRA medium dose<br>SLITone ULTRA HDM immunotherapy | Biological: SLITone ULTRA HDM immunotherapy<br> <br> |
| Active Comparator: SLITone ULTRA high dose<br>SLITone ULTRA HDM immunotherapy | Biological: SLITone ULTRA HDM immunotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in IgE-blocking factor after 6 months of treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment related adverse events |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
House Dust Mite, allergy, rhinitis, asthma
EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure

Study Overview
=================
Brief Summary
-----------------
Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful.

Official Title
-----------------
EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure

Conditions
-----------------
Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old, Hospitalized in surgical or neurosurgical intensive care units Patients under mechanical ventilation for more than 48 hours, Meeting the criteria for severability (spontaneous ventilation test), Free subject, without tutorship or curatorship or subordination, Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party, No objection given by the patient and / or relative after clear and fair information about the study. Exclusion Criteria: Tracheostomized patients, Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection, Pregnant and / or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of re-intubations after extubation |  | 7 days |
A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.

Official Title
-----------------
An Open-Label, Multi-Center, Prospective, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery for Hypertrophic Scars in Healthy Adults

Conditions
-----------------
Hypertrophic Scar

Intervention / Treatment
-----------------
* Drug: RXI-109


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 21-55 years of age General good health Previous surgery or injury resulting in a hypertrophic scar Exclusion Criteria: Scars on the face or front of neck may not be included in the trial Use of tobacco or nicotine-containing products Pregnant or lactating

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RXI-109<br>RXI-109 dosed at the site of the revised hypertrophic scar | Drug: RXI-109<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing the recurrence of hypertrophic scar after scar revision surgery | To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of RXI-109 | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertrophic scar, Cicatrix, Scar prevention, Scar revision
ClearPath DS-120 Clinical Study Protocol

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to measure lens fluorescence in normal subjects at various chronological ages that could serves as a guide to clinicians in determining changes in eye health. A measure of lens fluorescence can be used by clinicians as an indication of degenerative changes occurring in the lens of the eye.

Official Title
-----------------
Freedom Meditech ClearPath DS-120 Clinical Study Protocol FM2-002-CTP

Conditions
-----------------
Ophthalmic, Healthy Eyes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons between the ages of twenty-one (21) and seventy (70). Best efforts shall be made to include as many patients as possible between the ages of thirty-five (35) and sixty (60). Subject must be able to read or understand and give informed consent. Pass the medical health history and comprehensive ophthalmic examination (which is determined by the investigator if the test subject has a normal ophthalmic examination and is in overall good health). Ophthalmic examination includes a clinical evaluation of the subject's eyes and a complete manifest refraction producing a best aided visual acuity of <20/40. Exclusion Criteria: Subject has had the crystalline lens removed from the study eye or has had the crystalline lens removed and replaced with an intraocular lens (IOL) implant in the left eye. Subject has been clinically diagnosed with cataracts in the study eye. Subject has had a fluorescence angiogram within the last six months. Subject has undergone a treatment using photodynamic drugs within the last year. Subject has Type I or II diabetes or is not deemed healthy from Demographic and Health Questionnaire or the comprehensive eye exam. Subject was fit with contact lens within the last 30 days. Subject has ocular surface (dry eye) disease. Subject is unable to cooperate with or understand clinical instructions. Subject is unable to complete test sequence

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 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 |
| --- | --- |
| Normal Healthy<br>Normal, healthy males and females between the ages of 21 and 70 with healthy eyes as determined by a standard ophthalmic examination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens fluorescence | evaluate the ability of the ClearPath DS-120 instrument to measure the fluorescence and scattering responses of the human crystalline lens in a normal subject population with healthy eyes (as determined by standard comprehensive ophthalmic examination). | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ophthalmic, healthy eye, fluorescence, lens
Retrospective Analysis of De-identified Deceased HCC Patients

Study Overview
=================
Brief Summary
-----------------
De-identified deceased HCC patients who were not surgical candidates were evaluated for their clinical baseline characteristics associated with their survival. Baselines included tumor markers, blood counts and liver function tests and CAT-scan based tumor size and numbers and presence of portal vein thrombosis.

Official Title
-----------------
HCC Observation Study

Conditions
-----------------
Survival

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-proven HCC Exclusion Criteria: none

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 |
| --- | --- | --- |
| Survival | Overall survival | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCC, AFP, MTD, survival, NLR, PLR, Tumor Aggressiveness
Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal, consecutive case-series, multi-center study with mixed prospective and retrospective data collection. Data will be collected from eligible adults with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) treated with dacomitinib as first-line therapy from the date of advanced NSCLC diagnosis to the date of death, lost to follow-up, withdrawal of consent or end of study, whichever occurs first.

Official Title
-----------------
ARIA: Real-world Utilization and Outcomes With Dacomitinib First-line Treatment for EGFR Mutation-positive Advanced Non-small Cell Lung Cancer Among Asian Patients - A Multi-center Chart Review

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: Dacomitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (aged ≥18 years) with histology-confirmed advanced NSCLC (TNM stage IIIB-IV); Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment; Initiating dacomitinib as first-line treatment after confirmation of EGFR-mutation status (ie, no prior treatment with other EGFR TKI or systemic therapy); Exclusion Criteria: Enrolled in any interventional clinical study or trial (however, patients enrolled in non-interventional, real world study may still be included).

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 |
| --- | --- |
| Cohort 1<br> | Drug: Dacomitinib<br>* This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who initiated dacomitinib at 45mg, 30mg and 15mg dose respectively |  | Uo to 3 years | 
| Proportion of patients that experience dose modification |  | Up to 3 years | 
| Proportion of patients that experience dose interruption |  | Up to 3 years | 
| Proportion of patients that experience dose discontinuation |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real world progression-free survival |  | Up to 3 years | 
| Overall response rate |  | Up to 3 years |
Salbutamol Tolerance Onset

Study Overview
=================
Brief Summary
-----------------
Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.

Official Title
-----------------
Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: salbutamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female 18 to 65 years of age non smoker beta agonist naive for at least 14 days baseline FEV1 at least 70% predicted no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1 Exclusion Criteria: poorly controlled asthma pregnant or lactating women

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: salbutamol<br> | Drug: salbutamol<br>* 200mcg twice daily for a total of 7 doses<br>|
| Placebo Comparator: placebo<br>200mcg twice daily for a total of 7 doses | Drug: Placebo<br>* 200mcg twice a day for a total of 7 doses (3.5 days).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway responsiveness as a measure of salbutamol bronchoprotection | Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance. | ten minutes post 200mcg salbutamol on day 1 | 
| Airway responsiveness as a measure of salbutamol bronchoprotection | Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance. | ten minutes post 200mcg salbutamol on day 3 | 
| Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance. | Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance. | ten minutes post 200mcg salbutamol on day 5 | 
| Airway responsiveness as a measure of salbutamol bronchoprotection | Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance. | ten minutes post 200mcg salbutamol on day 7 |
Is Self-action Observation More Effective Than Observing Another Person's Action?

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the possible effects of self-action observation and observation of another person's action on upper extremity functionality, cognitive functions and reaction times.

Official Title
-----------------
Is Self-action Observation More Effective Than Observing Another Person's Action During Upper Extremity Functions?

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Other: Action Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old willingness Exclusion Criteria: any kind of neurological or musculoskeletal problems sight problems pain in the upper limb

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Action Observation (s-AO Group)<br>Participants will watch their own actions during an upper extremity functionality test. | Other: Action Observation<br>* Participants will watch an upper extremity functionality test.<br>|
| Experimental: Action Observation (AO Group)<br>Participants will watch another person's actions during an upper extremity functionality test. | Other: Action Observation<br>* Participants will watch an upper extremity functionality test.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in upper extremity functionality | Jebsen-Taylor Hand Function Test will be used | The outcome will be assessed at baseline and immediately after the intervention. |
Continuing Medical Education to Improve Knowledge of Viral Hepatitis B-C in Primary Healthcare Workers

Study Overview
=================
Brief Summary
-----------------
The purpose of study is identifying the effectiveness of 'continuing medical education' (CME) to primary healthcare worker to improve knowledge about viral hepatitis B-C

Official Title
-----------------
Continuing Medical Education (CME) Intervention to Improve Knowledge About Viral Hepatitis B-C: A Randomized Controlled Trial Pilot at Primary-level Hospitals in Ho Chi Minh City

Conditions
-----------------
Viral Hepatitis

Intervention / Treatment
-----------------
* Behavioral: Continuing medical education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently working at Outpatient department, Primary-level hospitals Having Practicing Certificate Not attending any long-term education Accepting ICF Exclusion Criteria: Not attending the full number of lessons Not answering the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 24 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Received CME<br> | Behavioral: Continuing medical education<br>* Education section about knowledge of transmissions, severity of viral hepatitis B-C and update treatment strategy of the HBV-HCV<br>|
| No Intervention: Not received CME<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Test Scores on Knowledge about Hepatitis B-C from Baseline to 6 months | Participants have exams pre- and post-6-months-course, which is multiple choice questions. The test score is average number of correct answers. The pre- and post-6-months exams use the same structure and questions. A change in test score is the difference between test score of the post-6-months-exam and test score of the pre-course-exam. | 6 months |
Airway Inflammation in Swimmers

Study Overview
=================
Brief Summary
-----------------
Studies have shown that the prevalence of respiratory symptoms, airway hyperresponsiveness (AHR) and asthma is high and increasing in elite athletes. The inflammation seen in the airways of elite athletes might differ from the inflammation seen in the airways of ordinary asthmatics and it might represent a different kind of asthma. The primary purposes are To investigate the type of airway inflammation in young swimmers. To investigate the acute changes in airway inflammation after a short training session.

Official Title
-----------------
Airway Inflammation in Swimmers: Development and Risk Factors

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Swimmer Exclusion Criteria: Current smoker or more than 3 pack-years

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 16 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Airway inflammation, Sport