linjc16/ctgov huggingface dataset:
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with cataract surgery.

Conditions
-----------------
Cataract Extraction, Pain, Inflammation

Intervention / Treatment
-----------------
* Drug: ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cataract surgery Exclusion Criteria: Uncontrolled ocular disease in cataract surgery eye

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ketorolac<br>* Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day. Placebo<br>|
| Placebo Comparator: 2<br> | Drug: ketorolac<br>* Ophthalmic drops, BID pre- and post-operation, and 6 doses on surgery day. Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Post Operative Inflammation | Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = >50 cells) | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Pain | Measured on a scale of 0-4 (0 = none, 4 = intolerable) | Day 1 | 
| Mean Pupil Area | Pupil area post-irrigation and aspiration | Day 0 |
Bone Health in Facioscapulohumeral Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional single visit study to determine bone health in individuals with FSHD.

Detailed Description
-----------------
Bone health will be assessed using 1) a DEXA scan to measure bone mineral density and lean body mass, and 2) blood tests of biomarkers of bone resorption and formation. These procedures will be correlated to measures of muscle strength testing and timed function tests to determine fracture risk in FSHD individuals considering age, gender, muscle strength and FSHD allele size.

Official Title
-----------------
Bone Health in Facioscapulohumeral Muscular Dystrophy: A Cross-sectional Study

Conditions
-----------------
Facioscapulohumeral Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic diagnosis of FSHD including chromosome 4 deletion and haplotype Age > 18 years Ability to provide written informed consent for participation in the study Ability to participate in the DEXA scan Exclusion Criteria: Unwillingness or inability to comply with the requirements of this protocol (in the opinion of the PI) including, but not limited to, the presence of any condition (physical, mental or social) that precludes the participant from comfortably and safely obtaining a DEXA scan, phlebotomy, or neurological examination

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 |
| --- | --- | --- |
| Bone Mineral Density in FSHD | To determine if bone mineral density is reduced in individuals with FSHD compared to normative data of individuals of the same age and gender without FSHD.The Bone Mineral Density Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population | Single visit |
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.

Official Title
-----------------
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

Conditions
-----------------
Adolescent Idiopathic Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Adolescent Idiopathic Scoliosis Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing Skeletally immature (Risser Sign 0, 1, 2, or 3) In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months Age between 10 and 15 Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion Candidate for surgical implantation of spinal instrumentation Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol Must sign informed consent to permit the use of personal health data Exclusion Criteria: Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant Patients who require an MRI following implantation Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage) Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature History of previous surgical treatment for AIS

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 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 |
| --- | --- | --- |
| Change in major scoliotic curve magnitude | Measured in degrees | Change from baseline to 36 months postoperative | 
| Number and Types of Adverse Events |  | Operative through 36 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic evaluation coronal balance compared to baseline |  | Change from baseline to 36 months postoperative | 
| Radiographic evaluation sagittal balance compared to baseline |  | Change from baseline to 36 months postoperative | 
| Percent of patients indicated for surgical spine fusion |  | Change from baseline to 36 months postoperative | 
| Quality of life assessment via SRS-30 questionnaire |  | Change from baseline to 36 months postoperative | 
| Comparison of Rib Hump prominence |  | Change from baseline to 36 months postoperative | 
| Expected vs. Actual Device Lengthening |  | All postoperative visits where lengthening is conducted |
Pharmacokinetic Study of Indinavir Drug Levels When Boosted With Ritonavir in Thailand

Study Overview
=================
Brief Summary
-----------------
This study looks at the ways indinavir drug levels, when boosted with ritonavir, may vary from patient to patient. The study population are HIV+ Thai individuals.

Detailed Description
-----------------
This study will assess the inter-individual variability of indinavir drug levels, boosted with ritonavir, in Thai patients. Data will be collected in patients participating in the randomized study, Monitoring Highly Active Antiretroviral Therapy (HAART) in HIV-infected patients in Thailand (PHPT-3) (HSC 10668). The first 20 patents in PHPT-3 will have steady-state pharmacokinetic sparse sampling performed at pre-dose, and 1, 2.5, 4 and 12 hours after drug intake 1 and 2 months after initiating IDV/r 400/100 mg, twice daily. IDV/r plasma concentrations will be determined by high performance liquid chromatography. This spare PK data will be pooled with indinavir concentration data collected within an intensive pharmacokinetic studies of IDV/r [Cressey TR, et al 2005, JAC, 55, p1041-44]. Population means and variances of indinavir and ritonavir pharmacokinetic parameters were estimated using non-linear mixed effects regression models (NONMEM Version VI). The validity of the final model was evaluated using a visual predictive check (VPC) and bootstrap re-sampling techniques.

Official Title
-----------------
A Pharmacokinetic Study to Assess the Inter-patient Variability of Indinavir Drug Levels When Boosted With Ritonavir in Thai Patients on Highly Active Antiretroviral Therapy

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: Ritonavir-boosted indinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects enrolled in the parent study, Monitoring HAART Therapy in HIV-Infected Patients in Thailand (PHPT-3) and agreeing to additional blood sampling and tests. Exclusion Criteria: Current active substance or alcohol abuse Active opportunistic infection Chronic malabsorption or diarrhea Other clinically significant disease Certain lab values (e.g. hemoglobin < 8.0 mg/dL)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ritonavir-boosted indinavir|nan|

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
-----------------
indinavir, HIV, ritonavir, pharmacokinetics, Thailand
The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation

Study Overview
=================
Brief Summary
-----------------
【Background& Purpose】In order to early detect the problems a child might have during his/her development, an effective screening tool is of great needs. The [Taipei City Child Development Screening checklist] is often used to serve this process. This text version is mainly distributed to the parents to fill out during their child regular check-ups to the hospitals and clinics. The drawbacks of this checklist is that it lacks of active participation of the target population, and the text version limits its usage to people who are not familiar with Chinese characteristics, such as those new inhabitant. These lead to low screening rates therefore causing delayed early intervention. 【Purpose】The purpose of this study was to design and develop the multi-media graphic version of the [Taipei City Child Development Screening checklist] based on its original text version.【Method】The developed muti-media system will be checked for is validity. Thirty parents/legal guardians of children in each target age groups will be recruited randomly for the clinical reliability evaluation.

Official Title
-----------------
The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation

Conditions
-----------------
Child Development Checklist

Intervention / Treatment
-----------------
* Other: text-based or multimedia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For parents/primary caregivers whose children are between 3 months and 7 years old can participate. Exclusion Criteria: Any visual impairment.

Ages Eligible for Study
-----------------
Minimum Age: 20 Months
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| text-based or multimedia<br>Subject fills in a questionnaire regarding whether the child meets developmental milestones for his/her developmental age, both the text-based and the multimedia version. A total score will be calculated and compared. | Other: text-based or multimedia<br>* subjects fills in a questionnaire regarding whether the child meets the developmental milestones for his/her developmental age.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 13 developmental milestones questionnaire | there will be 13 developmental milestones in each age range. The guardian of each subject check yes/no depends on whether his/her child reaches the milestone | baseline |
Tissue Composition of Newborn Infants of Obese and Lean Mothers

Study Overview
=================
Brief Summary
-----------------
0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

Detailed Description
-----------------
Obese pregnant women (BMI > 30) are randomized to exercise, diet or control (1:1:1) in order to reduce weight gain during pregnancy. Shortly after birth, tissue composition will be measured (DEXA)in 200 infants (65 from each group). The amount of fat tissue is subsequently analyzed between the groups and compared to results from another 65 infants of lean mothers

Official Title
-----------------
Is it Possible to Reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention During Pregnancy ?

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

Intervention / Treatment
-----------------
* Behavioral: diet
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy term neonates Informed and written consent from both parents - Exclusion Criteria: Sick or preterm infants No consent -

Ages Eligible for Study
-----------------
Maximum Age: 3 Days

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet<br>Calorie restriction to reduce weight gain | Behavioral: diet<br>* calorie restriction to reduce weight gain<br>|
| Experimental: Exercise<br>Exercise to reduce weight gain | Behavioral: Exercise<br>* Exercise to reduce weight gain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of fat tissue |  | at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth weight |  | at birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, lifestyle, pregnancy, newborn infant
Effect of Covid-19 Epidemic on Primary PCI in Patients With STEMI

Study Overview
=================
Brief Summary
-----------------
The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic,which provide effective suggestions and strategies for emergency and severe treatment.

Detailed Description
-----------------
The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. The patients' prognosis is poor because the epidemic situation runs on medical resources, delays the diagnosis and treatment of other diseases such as cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more damage to the patients. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic. In this study, STEMI patients who experienced emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular opening time,and the major cardiovascular adverse events, which provide effective suggestions and strategies for emergency and severe treatment.

Official Title
-----------------
Effect of Covid-19 Epidemic on Primary PCI and Prognosis in Patients With Acute STEMI

Conditions
-----------------
STEMI

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continuous inclusion of patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention. Exclusion Criteria: Febrile patients, patients with severe infection, ST segment elevation myocardial infarction during hospitalization, Patients who could not cooperate with each other.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| before COVID-19<br>Patients with myocardial infarction from January 24, 2019 to June 24, 2019 | |
| after COVID-19<br>Patients with myocardial infarction from January 24, 2020 to June 24, 2020 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (major adverse cardiovascular events) | cardiovascular death, re-infarction, malignant arrhythmia,heart failure, revascularization, and stroke | 1 year | 
| all-cause death | death caused by all reason | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
covid-19, STEMI, primary PCI
Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Official Title
-----------------
Protocol for Drug Use Investigation of Follistim Injection

Conditions
-----------------
Anovulation

Intervention / Treatment
-----------------
* Drug: Follitropin beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent IVF Exclusion Criteria: Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus Pregnant or possible pregnant women, or lactating women Patients with undiagnosed atypical vaginal bleeding Patients with a history of hypersensitivity to any of the ingredients of this product Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction | Drug: Follitropin beta<br>* For subcutaneous or intramuscular injection, the usual dosage is 50 IU of follitropin beta (recombinant) once daily for 7 days. The dosage should be adjusted subsequently while monitoring the development of follicles (dose increase by 25 IU every 7 days if the response of the ovaries is poor) and, after confirming presence of follicles of 18 mm or larger in mean diameter by the ultrasonic tomography, ovulation is induced by the administration of a human chorionic gonadotropin preparation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of ovulation |  | 3 months, from initiation of treatment to confirmation of pregnancy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcome |  | 3 months, from initiation of treatment to confirmation of pregnancy. |
Dexmedetomidine for Sedation During Radiological Interventional Procedures

Study Overview
=================
Brief Summary
-----------------
Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.

Official Title
-----------------
Evaluation of Role of Dexmedetomidine as a Sole Agent in Sedation of Cancer Patients Undergoing Radiological Interventional Procedures

Conditions
-----------------
Procedural Sedation

Intervention / Treatment
-----------------
* Drug: Dexmeditomedine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18-65 years old ASA physical status of I-II Expected procedure lasting at least 30 minutes Exclusion Criteria: Unstable cardiac status (life-threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction and third-degree heart block. An alpha2-agonist or antagonist within 14 days before the scheduled procedure. patients received an IV opioid within 1 h, or an oral or IM opioid within 4 h of the start of study drug administration. Patients who are allergic to Dexmedetomidine or alpha 2-agonists.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmeditomedine<br>Dexmedetomidine will be initiated at 0.6 mcg/kg/hr and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr. | Drug: Dexmeditomedine<br> <br> * Other names: Dexmedetomidine at 0.6 mcg/kg/hr then 0.2 to 1 mcg/kg/hr.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of sedation | It will be measured and recorded by using the Ramsay sedation score. | 1 hour | 
| verbal analogue scale | assessment of pain using VAS score | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | assessment of patient satisfaction by 4 point scale | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomedine, sedation, interventional radiology