linjc16/ctgov huggingface dataset:
Stress Echocardiography Study With Regadenoson

Study Overview
=================
Brief Summary
-----------------
Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography.

Official Title
-----------------
An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography

Conditions
-----------------
Heart Disease, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: regadenoson


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinically indicated dobutamine echocardiogram showing normal wall motion at rest and abnormal wall motion with stress Patients with a clinically indicated dipyridamole echocardiogram showing normal perfusion and wall motion at rest and abnormal perfusion with or without abnormal wall motion with stress Exclusion Criteria: Any condition precluding the safe administration of dobutamine, dipyridamole or SonoVue for echocardiography Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regadenoson alone<br> | Drug: regadenoson<br>* 400 ug, IV<br>|
| Experimental: Regadenoson with exercise<br> | Drug: regadenoson<br>* 400 ug, IV<br>|
| Experimental: Regadenoson with contrast agent<br> | Drug: regadenoson<br>* 400 ug, IV<br>|
| Experimental: Regadenoson with contrast agent (perfusion)<br> | Drug: regadenoson<br>* 400 ug, IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent. |  | Within 12 minutes after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications. |  | Up to day 29 after dosing |
Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer

Official Title
-----------------
Randomized Phase II Study of Pemetrexed Versus Gefitinib in Previously Treated Patients With Advanced Non-small Cell Lung Cancer

Conditions
-----------------
Previous Treated Metastatic Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: Pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients second line ECOG 0～2 Patients with normal liver function and renal function Exclusion Criteria: Patients with severe acute infection requiring antibiotic therapy Patients who have received treatment in other areas of cancer within 5 years During pregnancy and lactation patients

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: pemetrexed<br>pemetrexed | Drug: Pemetrexed<br>* compare PFS rate, safety to both drugs<br>* Other names: alimta;|
| Active Comparator: gefitinib<br>gefitinib | Drug: Gefitinib<br>* compare progression free survivla rate and safety to both drugs<br>* Other names: irressa;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 5years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pemetrexed, Gefitinib, iressa, alimta
Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures. Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU. An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination. The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.

Official Title
-----------------
Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

Conditions
-----------------
Thoracolumbar Spine

Intervention / Treatment
-----------------
* Other: radiography standard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged at least 18; who underwent Kyphoplasty between T11 and L5, Patients who had Kyphoplasty at a single level without associated surgery, Magerl type-A fracture. Non-tumoral and non-osteoporotic cause. Exclusion Criteria: Compression fracture outside the T11-L5 segment, or fracture other than Magerl type A. Osteoporotic vertebral fracture Association with other post-traumatic fractures. History of Balloon Kyphoplasty, or of thoracic or lumbar spine surgery except simple discectomy. Pregnant or breast-feeding women Patients not covered by national health insurance

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 |
| --- | --- |
| Patients<br> | Other: radiography standard<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Spinal kyphosis angle |  | Between the post-operative period (D1) and a minimum of one year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of pain (VAS) |  | At least 1 year after the kyphoplasty | 
| Number of new vertebral fractures |  | At least 1 year after the kyphoplasty | 
| Evaluation of quality of life (OSWESTRY and EIFEL) |  | At least 1 year after the kyphoplasty | 
| Evolution of the regional angle of vertebral kyphosis |  | At least 1 year after the kyphoplasty | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kyphoplasty, at a single level, (between T11 and L5), associated surgery
Loving-kindness Meditation for Posttraumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
A before and after study of veterans who took part in a 12-week loving-kindness meditation course as an adjunct to their usual care for posttraumatic stress disorder.

Official Title
-----------------
An Open Pilot Study of Loving-Kindness Meditation for PTSD

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: loving-kindness meditation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: posttraumatic stress disorder Exclusion Criteria: psychosis borderline personality disorder

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: loving-kindness meditation<br> | Behavioral: loving-kindness meditation<br>* A 12-week duration, 90 minute per session loving-kindness meditation course<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in PTSD symptoms | The PTSD symptom-scale interview was performed | baseline, post-intervention, 3-month follow-up | 
| change in depressive symptoms | The PROMIS measure for depression was administered | baseline, post-intervention, 3-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
posttraumatic stress, depression
Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles

Study Overview
=================
Brief Summary
-----------------
Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice.

Detailed Description
-----------------
Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.

Official Title
-----------------
A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: BAY98-7071_EE20/DRSP/L-5-MTHF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients ≥ 18 years old Requiring contraception Prescribed with Yaz Plus for the first time Exclusion Criteria: Contraindications for the use of Yaz Plus in accordance with the local product information

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Female patients ≥ 18 years old requiring contraception. | Drug: BAY98-7071_EE20/DRSP/L-5-MTHF<br>* Patients treated by Physicians under approved local prescriptions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent) |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in EVAPIL scale for assessment of tolerability of oral contraceptives. |  | Baseline to 12 months | 
| Number of participants with adverse events as a measure of safety and tolerability |  | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Personal Satisfaction
Daily Disposable Toric Comparative Trial in Europe

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: nelfilcon A contact lens
* Device: ocufilcon D contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters. Achieve 0.5 or better distance visual acuity in each eye at time of dispense. Achieve acceptable or optimal fit in each eye at time of dispense. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Habitual daily disposable contact lens wearer. Sleeps in contact lenses overnight. Currently enrolled in an ophthalmic clinical trial. Other protocol-defined exclusion criteria may apply.
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: nelfilcon A / ocufilcon D<br>Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. | Device: nelfilcon A contact lens<br>* Commercially marketed, toric, soft contact lens for daily disposable wear<br>Device: ocufilcon D contact lens<br>* Commercially marketed, toric, soft contact lens for daily disposable wear<br>|
| Other: ocufilcon D / nelfilcon A<br>Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. | Device: nelfilcon A contact lens<br>* Commercially marketed, toric, soft contact lens for daily disposable wear<br>Device: ocufilcon D contact lens<br>* Commercially marketed, toric, soft contact lens for daily disposable wear<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | Overall Comfort, as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall comfort is measured on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear |
Do Patients With Chronic Daily Headache Have Continuous Headache or Moments of Headache Relief?

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine if patients with chronic daily headache have continuous headache or moments of headache relief. The secondary objective of this study is to determine the period of time patients who have chronic daily headache that is not continuous are headache free.

Detailed Description
-----------------
This study is a retrospective chart review of all patients over the age of 18 who are seen by the co-investigator during one initial, or routine follow up visit, with the diagnosis of chronic migraine, chronic tension type headache, new daily persistent headache, or chronic post traumatic headache(per International Headache Classification II guidelines6). Patients with the above diagnosis during their routine care are asked five standard questions about their headaches by the co-investigator, and the responses are recorded in the patient's medical record (see question sheet attached). These questions pertain to the patients' health care, and are asked of most patients at the Jefferson Headache center with chronic headache routinely during office visits.

Official Title
-----------------
Do Patients With Chronic Daily Headache Have Continuous Headache or Moments of Headache Relief?

Conditions
-----------------
Chronic Daily Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Chronic Migraine, New Daily Persistent Headache, Chronic Tension type headache, or chronic post traumatic headache seen at the Jefferson Headache Center. Exclusion Criteria: Subjects under age 18.

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 |
| --- | --- |
| Participants with continuous headache<br> | |
| Participnts with non-continuous headache<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Daily Headache Who Have Continuous Headache | The number of subjects with Daily Headache who have continuous headache | Records were reviewed from April 2009 through June 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patient With Daily Headache Who Have Non-continuous Headache | Number of patient with Daily Headache who have non-continuous headache | Records were reviewed from April 2009 through June 2009 |
Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.

Detailed Description
-----------------
Sampling method: invitation to the physician's patients.

Official Title
-----------------
Observational Study Evaluating the LDL-C Lowering Effects of Ezetimibe With a Statin as Prescribed in Daily Routine Practice in an Indonesian Population

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

Intervention / Treatment
-----------------
* Drug: ezetimibe
* Drug: statin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Not previously treated<br>subjects with hypercholesterolemia, who had never been treated with any cholesterol-lowering agent, and received the combination of ezetimibe 10 mg and a statin as initiation therapy | Drug: ezetimibe<br>* 10 mg once daily<br>* Other names: SCH 58235;Drug: statin<br> <br> |
| Previously treated with statin<br>subjects with hypercholesterolemia, who were previously treated with a statin, and received ezetimibe 10 mg as add-on therapy | Drug: ezetimibe<br>* 10 mg once daily<br>* Other names: SCH 58235;Drug: statin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Adverse Events | Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.) | 4-6 weeks after the first visit | 
| Intensity of Adverse Events Reported | Intensity of adverse events reported after co-administration therapy | 4-6 weeks after the first visit | 
| Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy | Achievement of LDL-C target levels as determined by physician | 4-6 weeks after the first visit |
Procalcitonin in Pleural Pleuritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine pleural level of procalcitonin in differents situations of pleuritis.

Detailed Description
-----------------
Determine pleural level of procalcitonin in pleuritis. Two periods First period evaluation in vitro study/ Determine adequat technique included type of samples tubes for adequat analysis. Second periods : Patient with pleuritis . Empyema or not

Official Title
-----------------
Evaluation de la Mesure du Taux de la Procalcitonine Dans Les Liquides Pleuraux

Conditions
-----------------
Pleuritis, Pleural Empyema

Intervention / Treatment
-----------------
* Other: pleural level of procalcitonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pleuritis Hospitalisation Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| patients with pleuritis<br> | Other: pleural level of procalcitonin<br>* no intervention<br>|

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
-----------------
pleuritis, empyema, procalcitonin