linjc16/ctgov huggingface dataset:
Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.

Official Title
-----------------
Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: fluticasone propionate/salmeterol xinafoate combination


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006). Continuous medical and pharmacy eligibility for the 12 month Pre-Index year and the 12 month Index year (referred to as the 24 month Observation Period), and the 3 month Post-Index period (referred to as the Outcome Period). At least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9 code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an Anticholinergic medication, both occurring during the12 month pre-index period. At least 40 years old at index date. EXCLUSION CRITERIA any medical claim (ever) with a primary or secondary diagnosis of cystic fibrosis (ICD-9 code 277.0x).

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| COPD<br>Patients with a diagnosis code of COPD | Drug: fluticasone propionate/salmeterol xinafoate combination<br>* fluticasone propionate/salmeterol xinafoate combination<br>* Other names: Advair (TM);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Pharmacy Claims by Participants During the Post-Index Period | The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured. | One Year | 
| Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period | The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured. | One Year |
Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)

Study Overview
=================
Brief Summary
-----------------
A clinical study to collect additional data in order to characterize the reduction in PSA with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the ages of 40 to 60 years.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Multicenter Study To Examine the Effects of Finasteride 1 MG on Serum Prostate-Specific Antigen in Men With Androgenetic Alopecia

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Drug: MK0906, finasteride / Duration of Treatment : 48 Weeks
* Drug: Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Men 40 to 60 years of age, and in good general physical and mental health, with androgenetic alopecia Exclusion Criteria : History of previous bladder surgery, acute urinary retention, urethral strictures, repeated urethral catheterizations, repeated urinary tract infections, or active urinary tract infections History of treatment with finasteride (PROSCAR or PROPECIA) or hypersensitivity to any component of finasteride.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

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: MK0906, finasteride / Duration of Treatment : 48 Weeks|nan|
|Drug: Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug |  |  |
Seroquel in Bipolar Depression Versus Lithium

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

Official Title
-----------------
Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

Conditions
-----------------
Bipolar Disorder, Bipolar Depression, Depression

Intervention / Treatment
-----------------
* Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization. Exclusion Criteria: Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment, History of non-response to an adequate treatment Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk Pregnancy or lactation Clinically relevant disease or clinical finding

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MADRS total score response |  |  | 
| MADRS total score remission |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, bipolar depression, depression
Comparison of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube (DLT) Intubation

Study Overview
=================
Brief Summary
-----------------
Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor double-lumen tube intubation. In this study, we will investigate its role in double-lumen tube intubation by comparison with another videolarygoscope.

Detailed Description
-----------------
The investigators designed a randomised controlled study to compare of McGrath Series 5 and Airtraq videolaryngoscope for DLT intubation in intubation time and the first attempt success rate.

Official Title
-----------------
A Randomised Controlled Trial Comparing of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube Intubation in Patients With Low Airway Risk Index Score

Conditions
-----------------
Intubation;Difficult, Thoracic Disease, Intubation Complication

Intervention / Treatment
-----------------
* Device: McGrath Series 5
* Device: Airtraq


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Thoracic surgery required one lung ventilation Exclusion Criteria: ASA physical status >4 Emergent operation planned tracheotomy difficult intubation predicted by a simplified airway risk index score

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: McGrath Series 5<br>DLT intubation with McGrath Series 5 videolaryngoscope | Device: McGrath Series 5<br>* one kind of videolaryngoscopes, which are widely used in airway management.<br>|
| Active Comparator: Airtraq<br>DLT intubation with Airtraq videolaryngoscope | Device: Airtraq<br>* another kind of videolaryngoscopes, which are also widely used in airway management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | defined as time from inserting blade to mouth to withdrawal of blade, measured with a stopwatch | at intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of successful intubation at first attempt |  | at intubation | 
| total successful rate of DLT intubation |  | at intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
videolaryngoscope, double-lumen tube, intubation
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.

Official Title
-----------------
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

Conditions
-----------------
Dentin Sensitivity

Intervention / Treatment
-----------------
* Other: Mouthrinse (IQP-OLP-101)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one hypersensitive tooth in everyday life after PAV 1 in-office visit At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit At least one tooth with dentine hypersensitivity to air stimulation → VAS ≥ 40mm at study entry Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root For subjects entering the study at stage PAR-control: good healing of the periodontal surgery site, cause of pain must not be the result of the periodontal surgery Age ≥ 18 years and ≤ 75 years Willing and able to attend the on-study visits Willing and able to understand and to follow the study procedures and instructions Good oral hygiene throughout the study Written informed consent before participation in the study Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control) Exclusion Criteria: Hypersensitivity only due to sweets Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc lactate Professional desensitizing therapy during the previous 3 months; GLUMA (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months Chronic systemic anti-inflammatory and analgesic medications Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.) Teeth or supporting structures with any other painful pathology or defect Subject with poor health conditions Concurrent participation in another clinical trial Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Treatment Group<br> | Other: Mouthrinse (IQP-OLP-101)<br>* Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dentine hypersensitivity | Assessed by subjects using VAS | 28 days |
Study of Biomarkers of the Response to Biotine

Study Overview
=================
Brief Summary
-----------------
Biotine is proposed by neurologists to patients with a progressive form of Multiple sclerosis (MS) in the context of a nominative temporary authorization for use (TAU) as a disease-modifying treatment for their MS. A recent study showed that with this treatment, more patients experienced an improvement after one year in comparison with patients given a placebo. The objective of this study is to identify blood biomarkers to determine good responders as early as possible. In addition, the blood parameters studied will make it possible to better understand the mechanisms of action, that have a beneficial effect on multiple sclerosis. The management of patients will not be modified: same number of consultations (at the prescription, at 3 months, at 12 months), same clinical examination, and the same number of blood samples (at the prescription, at 3 months, and at 12 months).

Official Title
-----------------
Single-centre, Observational Study, Concerning Blood-lipid Biomarkers of the Response to Treatment With Biotine, Prescribed in the Context of a Nominative TAU (Temporary Authorized Use) in Patients With an Inactive Progressive Form of Multiple Sclerosis (MS).

Conditions
-----------------
Multiple Sclerosis, Biotine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 years old inactive progressive form of MS according to the Lublin classification and recorded in the Burgundy EDMUS database Patients with health insurance cover Patients who have provided written informed consent (OFSEP) Exclusion Criteria: Patients unable to understand the information sheet Patients with remittent or active progressive MS Patients with a change in the disease-modifying treatment within the previous 3 months Patients treated with corticosteroids in the month before inclusion Impossibility to provide patients with the necessary information Patients in custody Patients under guardianship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| validated disability scale (EDSS) |  | change from baseline validated disability scale at 3 and 12 months | 
| Walking test |  | change from baseline walking test at 3 and 12 months | 
| Evolution of blood lipid biomarkers |  | change from baseline evolution of biomarkers at 3 and 12 months |
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

Study Overview
=================
Brief Summary
-----------------
Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.

Official Title
-----------------
Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

Conditions
-----------------
Sore Throat

Intervention / Treatment
-----------------
* Drug: Lidocaine jelly application
* Drug: Normal saline application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III Patients scheduled for general anesthesia with endotracheal intubation Patients scheduled for surgery which duration is expected to less than 3 hr Exclusion Criteria: Difficult airway Rapid sequence induction Recent sore throat Recent upper respiratory infection Asthma Chronic obstructive pulmonary disease Chronic cough Pregnancy Allergy to lidocaine Friable teeth History of head and neck surgery Multiple intubation attempts Regional anesthetic agents Gastric tube Dexamethasone

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Normal saline will be applied to the endotracheal tube. | Drug: Normal saline application<br> <br> |
| Active Comparator: Lidocaine<br>Lidocaine jelly will be applied to the endotracheal tube. | Drug: Lidocaine jelly application<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with sore throat |  | At 24 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with sore throat |  | At 1, 6, and 12 hr | 
| Number of participants with hoarseness |  | At 1, 6, 12 and 24 hr | 
| Number of participants with throat numbness |  | At 1, 6, 12 and 24 hr | 
| Number of participants with nausea |  | At 1, 6, 12 and 24 hr | 
| Number of participants with vomiting |  | At 1, 6, 12 and 24 hr | 
| Number of participants with cough |  | At 1, 6, 12 and 24 hr | 
| Number of participants with dry mouth |  | At 1, 6, 12 and 24 hr | 
| Number of participants with additional pain medication |  | At 24 hr |
myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies

Study Overview
=================
Brief Summary
-----------------
The diagnosis of the different forms of inflammatory myopathies (polymyositis, dermatomyositis, inclusion-body myositis...) remains difficult which may lead to unappropriate patient care. Objective 1 : to develop and evaluate the diagnostic value of a dedicated DNA-array (myoARRAY) for adult-onset muscular diseases with focus on inflammatory myopathies. Objective 2 : to evaluate the diagnostic value of T cell repertoire (TcLand) analysis to distinguish different forms of inflammatory myopathies.

Official Title
-----------------
Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.

Conditions
-----------------
Polymyositis, Dermatomyositis

Intervention / Treatment
-----------------
* Other: transcriptome analysis
* Other: T cell repertoire analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication of muscle biopsy for diagnostic purpose written informed consent Exclusion Criteria: vasculitis coagulation disorder, impossibility to perform muscle biopsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: no arm<br>no arm | Other: transcriptome analysis<br>* transcriptome analysis from muscle biopsy<br>Other: T cell repertoire analysis<br>* blood T cell repertoire analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transcriptome |  | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myositis, cDNA arrays, Genes, T-Cell Receptor beta
A Study to Detect Progression of Mass Effect From Unilateral Brain Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.

Official Title
-----------------
Early Non-invasive Detection of Progression of Mass Effect From Unilateral Brain Lesions

Conditions
-----------------
Non-traumatic Hemispheric Brain Lesions

Intervention / Treatment
-----------------
* Device: Non-invasive bilateral monitoring of ICP waveform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation. Patients admitted the Neuroscience ICU for serial neurological monitoring. Patients whose care is not expected to include immediate surgical decompression. Exclusion Criteria: Patients under the age of 18. Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent.

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring<br>Imaging guided by monitoring results | Device: Non-invasive bilateral monitoring of ICP waveform<br>* Brain4care non-invasive bilateral monitoring of ICP waveform<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome | modified Rankin score | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging utilization | Number of imaging scans | within ICU admission |