linjc16/ctgov huggingface dataset:
Safety and Efficacy of Relestat Ophthalmic Solution 0.05% for Allergic Conjunctivitis in Korea

Study Overview
=================
Brief Summary
-----------------
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Relestat Ophthalmic Solution 0.05% in patients with allergic conjunctivitis who are treated with Relestat as standard of care in clinical practice.

Conditions
-----------------
Conjunctivitis, Allergic

Intervention / Treatment
-----------------
* Drug: Relestat Ophthalmic Solution 0.05%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Allergic Conjunctivitis treated with Relestat Ophthalmic Solution in clinical practice. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relestat Ophthalmic Solution 0.05%<br>Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice. | Drug: Relestat Ophthalmic Solution 0.05%<br>* Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Reporting Adverse Events | An adverse event is 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. | Up to 10 Months | 
| Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale | Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement. | Baseline, 2 Weeks |
Changing Chat: Diaper Tips to Improve Language Development

Study Overview
=================
Brief Summary
-----------------
This randomized trial has two sets of diapers-- a normal one and one that has tips for how to talk to and engage your toddler. The investigators are hoping that the intervention improves language development.

Official Title
-----------------
Changing Chat: Diaper Tips to Improve Language Development

Conditions
-----------------
Healthy Infants

Intervention / Treatment
-----------------
* Device: Changing chat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16-18 months of age developmentally normal English speaking Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Months
Maximum Age: 18 Months

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Changing chat<br>Diapers will have tips on them | Device: Changing chat<br>* Diapers with tips<br>|
| Active Comparator: Control<br>Normal diapers | Device: Changing chat<br>* Diapers with tips<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Language development as measured by the Mcarthur Bates CDI |  | 6 months after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
language development, parental interaction
Evaluation of the Control Level of Asthmatic Patients With Seasonal Increase of Respiratory Symptoms (High and/or Low)

Study Overview
=================
Brief Summary
-----------------
To evaluate the level of control of Asthma (GINA : controlled, partially controlled, not controlled) of asthmatic patients consulting their general practitioner for a seasonal increase of respiratory symptoms (high and / or low) whether an inhaled corticotherapy is taken or not.

Official Title
-----------------
Evaluation of the Control Level (GINA) of Asthmatic Patients Consulting Their General Practitioner for a Seasonal Increase of Respiratory Symptoms (High and / or Low), Whether an Inhaled Corticotherapy is Taken or Not

Conditions
-----------------
Asthma, Respiratory Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatic adults consulting for a seasonal increase of respiratory symptoms (high/low) and treated with PRN fast acting bronchodilator alone or associated with inhaled IGCS, excluding all other treatments for asthma.

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the control level of Asthma of asthmatic patients consulting their GP for a seasonal increase of respiratory symptoms (high/low) with an inhaled corticotherapy or not. |  | One shot (patients will only have one visit to attend - this visit will take place between May 09 and September 09) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma seasonal respiratory symptoms, Asthmatic patients with increase of respiratory symptoms
Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)

Study Overview
=================
Brief Summary
-----------------
Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Iodixanol 320 mg I/Ml


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate >75 beats per minute (bpm) will be included. Exclusion Criteria: Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iodixanol 320 mg I/Ml|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean heart rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality |  |  | 
| Diagnostic quality |  |  | 
| Overall diagnostic information |  |  | 
| Frequency and intensity of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDCT, Coronary Artery, Heart Rate, Image Quality, Diagnostic Quality
Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects

Study Overview
=================
Brief Summary
-----------------
Background: The percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. This study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability. Methods: The authors compared the work capability and employment of 35 patients with traumatic cranial bone defects after head trauma treated in the Neurosurgery Department of Assiut University Hospitals, Egypt from January 2013 to January 2018 before and after cranioplasty.

Detailed Description
-----------------
Cranioplasty is surgical repair of a cranial bone defect, important to cover defects following skull trauma for restoration of function, cosmoses and protective effects. Cranioplasty is the surgical procedure in which the autologous skull, synthetic materials (titanium, methyl methacrylate, polyetheretherketone implants, hydroxyapatite, and bioceramics are used to repair the skull defect

Official Title
-----------------
Does Cranioplasty Reduce Disability in Cases With Post Traumatic Skull Bone Defects

Conditions
-----------------
Cranioplasty, Disability Physical, Trauma

Intervention / Treatment
-----------------
* Procedure: Cranioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients with traumatic skull bone defects Exclusion Criteria: • Patients were not working before trauma

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 66 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 |
| --- | --- |
| Other: polymethyl methacrylate Cranioplasty<br>The Cranioplastic kit used (Teknimed, Biomaterials Innovation, Gentafix 1 ®, France) a biocompatible material that is composed of powder and liquid form of polymethyl methacrylate. | Procedure: Cranioplasty<br>* Bone grafts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with complications | the number of patients with complications after cranioplasty as a method of skull repair. | 6 months up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cranial defect, skull bone defects
Improving Health Services for Veterans With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Schizophrenia exacts a high toll on the lives of patients and their families and constitutes a major health care cost. VISN 5 has placed special emphasis on improving care for veterans with severe mental disorders, an effort recently recognized by the VA as a Program of Excellence in the Care of Seriously Mentally Ill Veterans.

Detailed Description
-----------------
Background: Schizophrenia exacts a high toll on the lives of patients and their families and constitutes a major health care cost. VISN 5 has placed special emphasis on improving care for veterans with severe mental disorders, an effort recently recognized by the VA as a Program of Excellence in the Care of Seriously Mentally Ill Veterans. Objectives: This study is implementing a set of promising QOC methods for assessing QOC for schizophrenia in routine settings, using the evidence-based treatment recommendations developed under the AHCPR/NIMH-sponsored Schizophrenia Patient Outcomes Research Team (PORT). Methods: A random sample of 350 persons with a schizophrenia spectrum disorder is being drawn from the VISN 5 sites. Patients must have more than one outpatient contact during the preceding six months. Each subject will participate in two one-hour interviews, one at baseline and another six months later. An informant, psychiatrist, therapist, etc. will also be interviewed to help validate participant response. Status: Project work is ongoing.

Official Title
-----------------
Improving Health Services for Veterans With Schizophrenia

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be adults currently in treatment for an Axis I schizophrenia spectrum disorder (DSM295) at VA. Exclusion Criteria:

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 |
| --- | --- |
| Group 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Investigation of Genetic Risk of Cardiovascular Disease in Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease is a complex multifactorial and polygenic disorder that is thought to result from an interaction between a person's genetic make up and various environmental factors. Although many studies have revealed that several genetic variants increase the risk of cardiovascular disease, the results of these studies remain controversial. The purpose of this study is to identify polymorphisms that confer susceptibility to cardiovascular disease and to clarify the adequacy of reported susceptibility gene polymorphisms. To complete this purpose, we will prospectively study over 5,000 local residents in whom relationship between these polymorphisms and occurrence of cardiovascular disease over 5 years.

Official Title
-----------------
Investigation of Genetic Risk of Cardiovascular Disease in Prospective Cohort Study, the Kitanagoya Genome (KING) Study for the Local Residents of Kitanagoya, Japan

Conditions
-----------------
Healthy, Coronary Disease, Myocardial Infarction, Cerebral Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects who undergo community-based annual health check in Kitanagoya city

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
12-Month Stability of Diurnal IOP Control on Cosopt

Study Overview
=================
Brief Summary
-----------------
To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Detailed Description
-----------------
Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)-it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.

Official Title
-----------------
12-Month Stability of Diurnal IOP Control on Cosopt

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Cosopt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral open-angle glaucoma Exclusion Criteria: contraindications to Cosopt pathology affecting tonometry

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 |
| --- | --- |
| Active Comparator: Cosopt<br>Cosopt twice daily in both eyes | Drug: Cosopt<br>* Cosopt twice daily in both eyes<br>* Other names: Dorzolamide/timolol fixed combination;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal Intraocular Pressure Control | Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, diurnal, intraocular pressure
Select Embryos by Time-lapse System for Single Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to establish a hierarchical embryo selection process by using the time-lapse imaging (TLI), combining the embryo cleavage patterns and timing parameters.

Detailed Description
-----------------
The embryos of patients undergoing in vitro fertilization (IVF) treatment is cultured to blastocyst stage and observed by TLI. The association of embryo cleavage patterns/timing parameters and good-quality blastocyst rates are evaluated by logistic regression and to establish a hierarchical embryo selection. The value of the selection process is assess by single embryo transfer (SET) on Day 3.

Official Title
-----------------
Study Embryos of IVF by Time-lapse System

Conditions
-----------------
Embryo

Intervention / Treatment
-----------------
* Other: time-lapse imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing assistant reproduction treatment Exclusion Criteria: Oocyte donation cycles
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: time-lapse imaging|Embryos are observed using time-lapse imaging (Primo Vision®). It is an incubator with a compact, sealed, and digitally inverted camera unit which can automatically acquire images.The system can record the actual developmental stage of the embryos, all the recorded images can be saved to be analyzed later using a special software program.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| good-quality blastocyst rate |  | 6 days post insemination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cleavage pattern, timing parameter, time-lapse
Kidney Dysfunction in Children and Young Adults Who Have Received Methotrexate for Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment. PURPOSE: This research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.

Detailed Description
-----------------
OBJECTIVES: Examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate. OUTLINE: Medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.

Official Title
-----------------
Renal Dysfunction With Low to Intermediate Dose Methotrexate in Acute Lymphoblastic Leukemia Treatment

Conditions
-----------------
Leukemia, Renal Toxicity

Intervention / Treatment
-----------------
* Drug: methotrexate
* Other: medical chart review
* Procedure: assessment of therapy complications


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute lymphoblastic leukemia Receiving low- to intermediate-dose methotrexate or received treatment (chemotherapy and/or radiation) at Vanderbilt Children's Hospital PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: methotrexate|nan|
|Other: medical chart review|nan|
|Procedure: assessment of therapy complications|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal toxicity, childhood acute lymphoblastic leukemia, adult acute lymphoblastic leukemia