linjc16/ctgov huggingface dataset:
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR

Official Title
-----------------
Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-induced Asthma

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

Intervention / Treatment
-----------------
* Drug: Levocetirizine dihydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female subjects ≥ 12 years 2 year history of seasonal allergic rhinitis documented hypersensitivity to local seasonal allergens (grass pollen) documented pollen-induced asthma without acute ongoing exacerbation of asthma or allergic rhinitis no continuous ongoing treatment for rhinitis or asthma Exclusion Criteria: non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity symptomatic rhinitis or asthma due to tree pollens currently treated by specific grass pollen immunotherapy suffering from non-allergic asthma chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids contraindication for salbutamol use

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Levocetirizine dihydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pollen-induced symptomatology of asthma; symptoms of rhinitis and asthma over the first 4 season weeks and during the entire observation period following the actual onset of the grass pollen season |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levocetirizine dihydrochloride, Xyzal tablets
Laser Based Focal Ablation of Low Grade Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.

Official Title
-----------------
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer

Conditions
-----------------
Low Grade Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Laser-based thermotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, 45 years of age or older Diagnosis of prostate adenocarcinoma Clinical stage T1c or T2a Gleason score of 7 or less A minimum of 12 biopsy cores sampled during diagnostic biopsy Three or fewer biopsy cores with prostate cancer No single biopsy core with greater than 50% of tumor involvement A radiographically visible prostate lesion on MRI with concordance to biopsy sextant A documented Karnofsky performance status of at least 70 Estimated survival of 20 years or greater, as determined by treating physician Ability to give informed consent Exclusion Criteria: Previous surgery, radiation, or androgen deprivation therapy for prostate cancer Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI History of previous pelvic radiation Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A) History of other primary non-skin malignancy within previous three years

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procedure/surgery<br> | Procedure: Laser-based thermotherapy<br>* MRI-guided transperineal placement of a laser probe into the prostate<br>* Other names: Visualase, Inc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events |  | Within 6 months of the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, cancer, ablation, laser-induced, focal therapy
Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)

Study Overview
=================
Brief Summary
-----------------
In this research study, the investigators are testing a new type of breast camera, called Molecular Breast Imaging, to see if it can find tumors in the subject's breast.

Detailed Description
-----------------
Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study. The investigators plan to recruit 200 patients who are scheduled to undergo a breast biopsy for a breast lesion considered suggestive or highly suggestive of DCIS as determined by a radiologist specializing in breast imaging. Each patient will have a suspicious area of calcification on mammography of extent < 3 cm, or a non-focal area of abnormality on ultrasound or MRI that is scheduled for evaluation by biopsy. Each patient will undergo an MBI study immediately prior to biopsy. The study coordinator will approach these patients and inform them of the research project. If they are interested in participating, informed consent will be obtained and the patient will be scheduled for the MBI study prior to the breast biopsy.

Official Title
-----------------
Evaluation of Molecular Breast Imaging in Patients With a High Likelihood of Ductal Carcinoma in Situ

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with a breast lesion suspicious for DCIS who are scheduled for a stereotactic breast biopsy. Lesion must be considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5). Women between 25 and 90 years of age. Exclusion Criteria: Unable to understand or sign a consent form. Pregnant or lactating. Physically unable to sit upright and still for 30-40 minutes.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected breast cancer<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
-----------------
MBI, Molecular Breast Imaging, Breast Cancer, DCIS, Breast, Calcifications, Microcalcifications
Bicarbonate in Patients With Out-of-hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.

Official Title
-----------------
Pilot Study of Bicarbonate Injection for Improving Outcome in Patients With Out-of-hospital Cardiac Arrest, Double-blind Randomized Control Trial

Conditions
-----------------
Cardiac Arrest, Metabolic Acidosis

Intervention / Treatment
-----------------
* Drug: Sodium bicarbonate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at 10 minutes of cardiopulmonary resuscitation Exclusion Criteria: age <18 trauma patient Do Not Resuscitate state

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 (Sodium bicarbonate)<br>Sodium bicarbonate 50cc (50mEq) intravenous injection over 2 min | Drug: Sodium bicarbonate<br>* Administer Sodium bicarbonate 50 mEq IV over 2 minutes<br>* Other names: Bivon;|
| Placebo Comparator: 2 (Normal saline)<br>Normal saline 50cc intravenous injection over 2 min | Drug: Normal saline<br>* Placebo<br>* Other names: 0.9% sodium chloride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return of Spontaneous Circulation (ROSC) | Percentage of Participants with Return of Spontaneous Circulation (ROSC) | checked during CPR, duration of ROSC >20 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sodium Bicarbonate
Pulmonary Artery Involvement in Takayasu's Arteritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the clinical manifestations, imaging features, and prognosis-related factors of pulmonary artery (PA) involvement in Takayasu's arteritis (TA), and to explore the early clinical features of PA involvement in TA patients.

Detailed Description
-----------------
Takayasu's arteritis patients with pulmonary artery involvement were enrolled into this study. The demographic information of the patients (age, sex, course of disease), symptoms at their admissions (cough, hemoptysis, dyspnea, palpitations, fever), laboratory examinations (blood lab routines, erythrocyte sedimentation rate, C-reactive protein), and imaging examinations (vascular ultrasonography, computed tomographic angiography, echocardiography, chest CT, CTPA, pulmonary perfusion imaging, pulmonary angiography, PET/CT) were collected by reviewing the cases. The prognostic information was collected by telephone follow-up. The follow-up end point was December 2015.

Official Title
-----------------
Pulmonary Artery Involvement in Takayasu's Arteritis: a Retrospective Study in China

Conditions
-----------------
Takayasu Arteritis, Pulmonary Artery Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Meet the diagnostic criteria of TA as defined by the American College of Rheumatology (ACR). 2.PA involvement: meet at least one of three items: (1) at least one of computed tomographic pulmonary angiography (CTPA), pulmonary perfusion imaging, or pulmonary arteriography suggests thickening of vessel wall, stenosis, aneurysm, or occlusion; (2) 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) suggests high intake of local radioactive material in pulmonary artery wall; (3) pulmonary artery systolic blood pressure is higher than 50 mmHg assessed by transthoracic echocardiography (defined as PAH), without left ventricular disease. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 67 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 |
| --- | --- | --- |
| Pulmonary Artery Systolic Blood Pressure | Pulmonary artery systolic blood pressure(PASP) assessed by transthoracic echocardiography when admission. PASP>50mmHg is defined as pulmonary hypertension. | 1day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Takayasu Arteritis, Pulmonary artery hypertension
β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the association between the use of β blockers and mortality among hospital survivors of acute myocardial infarction without heart failure.

Official Title
-----------------
β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute myocardial infarction patients only aged 18 to 100 years Exclusion Criteria: other final diagnosis besides acute myocardial infarction died in-hospital patients with missing mortality data aged > 100 patients with previous acute myocardial infarction or angina patients who have received coronary interventions before patients with heart failure patients with β blocker prior use patients contraindicated for β blocker use patients with use of a loop diuretic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 cause mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 6 months | 
| All cause mortality |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, mortality, evidence-based care, Myocardial Ischaemia National Audit Project, β blockers
Using a Voice Output Communication Aid to Facilitate Language Development in Young Children With ASD

Study Overview
=================
Brief Summary
-----------------
It was proposed that in order to teach these children to use a Voice Output Communication Aid (VOCA), it should be introduced through a play-based situation using parents as the primary interventionist.

Detailed Description
-----------------
The research will test the effectiveness of using the communication board to improve the frequency of communication and social engagement for these children, and the level or sophistication of that engagement. The study will test the effectiveness of using the communication board in a variety of settings and a variety of practitioners. The study will have sites in and near Jonesboro, Arkansas.

Official Title
-----------------
Using a Voice Output Communication Aid to Facilitate Language Development in Young Children With Autism Disorders

Conditions
-----------------
Autistic Disorder

Intervention / Treatment
-----------------
* Behavioral: communication training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Criteria for inclusion included a diagnosis of autism and agreement of the parents to participate and use the VOCA at home. Exclusion Criteria: Not diagnosed with Autism Spectrum disorder

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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: communication training<br>Participants were instructed in the use of a voices output communication aid. | Behavioral: communication training<br>* Participants were instructed in the use of a voices output communication aid.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Communication | Surveys of number of words Text data from VOCA Formal assessment instruments | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Review of text output from the VOCA | The VOCA records data on usage by day and time. We analyze the text data from the VOCA. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism spectrum Disorders, Voice Output Communication
The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's Disease

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Explore The Efficacy And Safety Of The NR2B NMDA Antagonist CP-101,606 In Patients With Idiopathic Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: NR2B NMDA Antagonist CP-101,606 (traxoprodil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30- 80-year-old PD patients (UK Parkinson's Disease Brain Bank criteria) with a Hoehn & Yahr stage score of 2-5 in the off state. Exclusion Criteria: Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NR2B NMDA Antagonist CP-101,606 (traxoprodil)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyskinesia Rating Scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fingertapping |  |  |
Corneal Collagen Cross-linking for Progressive Keratoconus

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Detailed Description
-----------------
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Official Title
-----------------
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus

Conditions
-----------------
Progressive Keratoconus

Intervention / Treatment
-----------------
* Drug: riboflavin ophthalmic solution
* Device: UVA Irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of keratoconus Documented progression over previous 24 months Decreased BSCVA Must complete all study visits Exclusion Criteria: Prior corneal surgery or Intacs History of delayed wound healing

Ages Eligible for Study
-----------------
Minimum Age: 14 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: Corneal Collagen Cross-linking (CXL) Treatment Group<br>riboflavin ophthalmic solution and UVA irradiation | Drug: riboflavin ophthalmic solution<br>* riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)<br>Device: UVA Irradiation<br>* UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes<br>* Other names: UV-X Illumination System;|
| Sham Comparator: Control Group<br>riboflavin ophthalmic solution without UVA irradiation. | Drug: riboflavin ophthalmic solution<br>* riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Maximum Keratometry (Kmax) | The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam. | baseline,12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
keratoconus, cross-linking, riboflavin, UVA light, cornea