linjc16/ctgov huggingface dataset:
Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the healthcare costs among patients with CML receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured population.

Official Title
-----------------
Costs and Outcome Among Patients With Chronic Myelogenous Leukemia (CML) Receiving Dasatinib or Nilotinib as First or Second Line Therapy in a Commercial and Medicare Population

Conditions
-----------------
Chronic Myeloid Leukemia (CML)

Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Age >18 years International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) code for CML (205.1x) At least 2 prescriptions for dasatinib or nilotinib from July 1, 2008 to June 31, 2013 Continuous eligibility for the 6 months pre- and post-index date (defined as the date of first fill for dasatinib or nilotinib) Exclusion Criteria: History of bone marrow or stem cell transplant as identified in the 6 month pre-period

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 |
| --- | --- |
| CML subjects receiving Dasatinib<br>CML receiving dasatinib as first or second line therapy will be conducted to assess healthcare costs | |
| CML subjects receiving Nilotinib<br>CML receiving nilotinib as first or second line therapy will be conducted to assess healthcare costs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare costs | Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy | Intent-to-treat (ITT) at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare costs by line of therapy |  | Intent-to-treat (ITT) at 6 months | 
| Resource utilization by line of therapy | Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions | Intent-to-treat (ITT) at 6 months |
A Safety and Efficacy Study of BOTOX® in Korean Adults With Chronic Migraine

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of BOTOX® treatment in Korean adults with chronic migraine.

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ethnically Korean with a diagnosis of chronic migraine Exclusion Criteria: Anticipated need for botulinum toxin treatment for any reason other than chronic migraine during the study Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin Type A<br>Botulinum toxin Type A injected across specific head and neck muscles on Day 0. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A injected across specific head and neck muscles on Day 0.<br>* Other names: onabotulinumtoxinA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Adverse Events | An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score | The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening. | Baseline, Day 28 | 
| Physician Global Assessment of Outcome on a 3-Point Scale | Physicians evaluated patient migraines as improved, no change, or worse compared to baseline. | Baseline, Day 28 |
RESTORE: Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization

Study Overview
=================
Brief Summary
-----------------
RESTORE is an observational, open-label, multi-center, prospective, study enrolling Raptiva® (efalizumab) treated patients with moderate to severe chronic plaque psoriasis. The overall duration of the study is approximately 4 years. Patients will be followed from the time of study enrolment to study/treatment termination; thus active follow-up period will vary across subjects. Raptiva® (efalizumab)treated patients with moderate to severe chronic plaque psoriasis and meeting the inclusion/exclusion criteria specified will be eligible for participation in this study. Objectives: To document and quantify the incidences of adverse events in this patient population To explore the association of psoriasis treatments with changes in patient outcomes, quality of life, and treatment compliance.

Official Title
-----------------
RESTORE (Raptiva® (Efalizumab) Evaluation of Safety and Treatment Optimization Registry) Observational, Open-label, Multi-centre, Phase IV Study of Subcutaneously Administered Raptiva® (Efalizumab) in the Treatment of Adult Patients With Moderate to Severe Chronic Plaque Psoriasis Who Are Candidates for Treatment With Raptiva®

Conditions
-----------------
Plaque Psoriasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 18 years old. Have a clinical diagnosis of moderate to severe chronic plaque psoriasis and be a candidate for treatment with Raptiva®. Are being treated or are initiating treatment with Raptiva® at time of study enrolment in accordance with the Canadian Product Monograph indication and recommendations. Be able to provide written informed consent. Agreement to participate in the study, and to disclose any medical events to the Investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study. Exclusion Criteria: Any contra-indication to Raptiva® according to the Canadian Product Monograph. Any simultaneous participation in another clinical evaluation trial for psoriasis

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All serious and unexpected AEs |  | During the course of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessed: static Physician's Global Assessment (sPGA). Patient assessed: Dermatology Life Quality Index (DLQI) |  | During the course of the study, there are no pre-defined scheduled visits | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate to severe plaque psoriasis
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis

Detailed Description
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Atopic Dermatitis.

Conditions
-----------------
Atopic Dermatitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD) Exclusion Criteria: - Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSXS topical product<br>DSXS Active treatment | Drug: DSXS<br>* Active treatment<br>* Other names: Active;|
| Placebo Comparator: Placebo topical product<br>Placebo treatment | Drug: Placebo<br>* Placebo treatment<br>* Other names: vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients in Each Treatment Group That Have Clinical Success | Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear [0] or almost clear [1]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in %BSA Affected at Day 28 ± 2 | The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2) | 28 days |
Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome

Study Overview
=================
Brief Summary
-----------------
Conflicting results have been reported concerning the association of pseudoexfoliation syndrome (PXF) and abdominal aortic aneurysms (AAA). Schumacher et al. reported an association between AAA and PXF, with no consideration of grade. However, a later study did not confirm the association between AAA and PXF. The present study aimed at comparing the relative prevalence of PXF in patients suffering from AAA and in age-matched hypertensive patients.

Official Title
-----------------
Abdominal Aortic Aneurysms Are Associated With Pseudoexfoliation Syndrome

Conditions
-----------------
Abdominal Aortic Aneurysms, Pseudoexfoliation Syndrome, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of abdominal aortic aneurism Systemic hypertension without abdominal aortic aneurism over 60 years old Exclusion Criteria: Unknown status for abdominal aortic aneurism

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| AAA group, control group<br>AAA group : with AAA Control group: without AAA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| standard ophthalmologic examination to group patients according to their pseudoexfoliation status |  | Day of standard ophthalmologic examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, abdominal aortic aneurysms, pseudoexfoliation syndrome
A Study of the Effects of an Employee Wellness Program

Study Overview
=================
Brief Summary
-----------------
Ochsner employees with a body mass index (BMI) greater than or equal to 30 will be enrolled in a fitness program consisting 90 days of a structured exercise program and dietary counseling. Measures of fitness including weight, BMI, cholesterol, HDL, blood pressure, and absenteeism rates will be measured at 0, 90 days, in one year.

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ochsner employees with a BMI greater than or equal to 30 Exclusion Criteria: Failure to pass initial physical exam

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
AZD8529 Multiple Ascending Dose Study in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses

Official Title
-----------------
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8529 When Given as Single and Multiple Ascending Oral Doses in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD8529
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects must be of non-child bearing potential. Exclusion Criteria: Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD8529<br>* oral<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential. |  | each visit, at least daily, during the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD8529 in plasma |  | Blood samples will be taken during the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I
Accuracy of Patient Specific Guide for TMJ Injection

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.

Detailed Description
-----------------
The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.

Official Title
-----------------
Evaluation of Patient Specific Guide Accuracy for TMJ Superior Joint Space Injection.

Conditions
-----------------
TMD

Intervention / Treatment
-----------------
* Procedure: TMJ injection using patient specific guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Patients who would not respond to conservative treatment as the first line of treatment. Exclusion Criteria: Lactating, pregnant or planning pregnancy women. Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: Patient specific guided injection<br>Patients treated with HA injection in TMJ using PSG and the accuracy evaluated using MSCT. | Procedure: TMJ injection using patient specific guide<br>* Prefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angle of deviation | The angle (°) between the planned and actual needle measured. | 1 month | 
| Vertical displacement of needle tip | The vertical displacement of the actual needle tip in comparison to the planned one (mm). | 1 month | 
| Overall needle tip dislocation | The distance between the planned and actual needle tips (mm). | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TMD, virtual planning, 3D printing
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control

Study Overview
=================
Brief Summary
-----------------
Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia progression.

Official Title
-----------------
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: low-dose atropine eye drops
* Device: orthokeratology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Best corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more. Exclusion Criteria: Children with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D. History of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity. History of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orthokeratology group<br> | Device: orthokeratology<br>* orthokeratology, ortho-K lenses<br>|
| Active Comparator: low-dose atropine group<br> | Drug: low-dose atropine eye drops<br>* low-dose atropine eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of myopia | The change of myopia (Ds) | 1 year | 
| Progression of axial length | The change of axial length (mm) | 1 year |
Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy

Study Overview
=================
Brief Summary
-----------------
a food collection will be performed in this study with type 1 diabetic patients trained to carbohydrate counting, to collect data on the meals consumed daily and their quantities for a period of 1 month.

Official Title
-----------------
Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy : GLUCAL2

Conditions
-----------------
Diabetes Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: type 1 diabetic patients Using carbohydrate counting and functional insulin therapy Patient with Social security or beneficiary Patient able to read and understand the procedure, and able to express consent for the study protocol Exclusion criteria: Patient abusing substances person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure -- Patient having a psychological conditions making him unable to follow and understand study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| number of meals | our primary outcome is to collect the description of 2000 meals from different patients correctly described. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Functional insulin therapy, carbohydrate counting