linjc16/ctgov huggingface dataset:
Function of Inner Ear Such as Balance and Perception of Verticality in Children With Idiopathic Scoliosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate vestibular function in children with idiopathic scoliosis as a possible cause of etiopathogenesis of its diagnose.

Official Title
-----------------
Vestibular Function in Adolescents With Idiopathic Scoliosis

Conditions
-----------------
Idiopathic Scoliosis, Vestibular Abnormality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: idiopathic scoliosis Exclusion Criteria: operation of the spine neurological disease hearing problems

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 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 |
| --- | --- |
| Children with idiopathic scoliosis<br>Adolescent between 10-18y with diagnosing idiopathic scoliosis | |
| Healthy children<br>Healthy children between 10-18y without any orthopedics problems | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vestibular evoked myogenic potentials | To evaluate the results of vestibular evoked myogenic potentials we used the latency (ms) and the amplitude (μV) of the positive wave (P13) and the negative wave (N23) | up to 6 months | 
| Posturography | Posturography was measured in 6 different sensory conditions. The posturographic parameters of center of pressure were measured for this study. | up to 6 months | 
| Perception of subjective visual vertical | We measured perception of subjective visual vertical (SVV) in static and dynamic conditions. Each participant completed a total of six trials for static SVV and twelve trials for dynamic SVV, in six trials the optokinetic background rotated clockwise and in six trials counterclockwise. Norms for static conditions are ±2° and for dynamic conditions ±4° | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
idiopathic scoliosis, subjective visual vertical, vestibular evoked myogenic potentials, posturography
Utrecht Coronary Biobank (UCORBIO)

Study Overview
=================
Brief Summary
-----------------
UCORBIO enrolls patients who undergo coronary angiography (for any indication). The investigators draw blood at the moment of insertion of the procedural arterial catheter. At the moment of inclusion indication, procedural details, risk factor status, medication use and quality of life (RAND-36 and EuroQoL) is assessed. Patients are then followed-up for the occurrence of major adverse cardiovascular events for 5 years. During the follow-up period patients receive a questionnaire every year to check for hospital admissions. The questionnaires at two and five years of follow-up are enriched with quality of life questionnaires (RAND-36 and EuroQoL).

Official Title
-----------------
Utrecht Coronary Biobank (UCORBIO)

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

Intervention / Treatment
-----------------
* Other: Observational study, no intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary angiography Exclusion Criteria: Age < 18 years.

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

| Intervention/Treatment |
| --- |
|Other: Observational study, no intervention.|Observational study, no intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events [MACE] (Stroke, myocardial infarction, coronary revascularization, death) | Stroke, myocardial infarction, coronary revascularization, death. | 5 years |
Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)

Study Overview
=================
Brief Summary
-----------------
To describe the prevalence, incidence and current treatment and procedures patterns in a US pediatric population with PAH in MarketScan database during the period 2010-2013

Official Title
-----------------
Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US

Conditions
-----------------
Hypertension, Pulmonary

Intervention / Treatment
-----------------
* Drug: Assigned pulmonary hypertension medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All PAH patients who were in the MarketScan database and who were under age 18 at some time during the years 2010 through 2013 Exclusion Criteria: Not applicable

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Pediatric PAH patients<br>US pediatric population with PAH in MarketScan database during the period 2010-2013 | Drug: Assigned pulmonary hypertension medication<br>* As assigned by treating physician; may include following product classes: - Calcium channel blockers/antagonists - Prostanoids (prostaglandins, thromboxanes, prostacyclines) - Endothelin receptor antagonists - PDE-5 inhibitors - SGc stimulators<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of PAH (pulmonary arterial hypertension) |  | Retrospective analysis of three year period | 
| Prevalence rate of PAH |  | Retrospective analysis of three year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assigned drug treatment for PAH measured using the MarketScan database | Description of pulmonary hypertension-targeted drugs prescribed in the study population and changes during the study period | Retrospective analysis of three year period | 
| Diagnostic procedures performed among PAH patients measured using the MarketScan database |  | Retrospective analysis of three year period | 
| Prevalence of comorbidities among PAH patients |  | Retrospective analysis of three year period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Arterial Hypertension
Pharmacokinetic Study of ABT-126 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ABT-126
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects between 18 and 50 years of age If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration Exclusion Criteria: Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder Presence of any uncontrolled medical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose 1 BID | Drug: ABT-126<br>* Dose administered twice daily on Study Days 1-10<br>|
| Experimental: 2<br>Dose 2 BID | Drug: ABT-126<br>* Dose administered twice daily on Study Days 1-10<br>|
| Placebo Comparator: 3<br>Placebo BID | Drug: Placebo<br>* Dose administered twice daily on Study Days 1-10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination) |  | One day before dosing through day of last dose and up to 6 days after last dose | 
| ABT-126 levels in blood (plasma) |  | First dose through last dose and up to 192 hours after last dose |
Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Objective: The purpose of the present study is to assess if perioperative variation of Brain Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic evaluation will be compared to other tools of risk stratification in cardiac surgery as the EuroScore. All patients will be followed 3 years after the procedure. Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact on BNP secretion during the perioperative period.

Official Title
-----------------
Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery

Conditions
-----------------
Coronary Artery Disease, Valvular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who need cardiac surgery Age > 18 years Exclusion Criteria: Patient on mechanic ventilation before surgery Aortic dissection-Congenital disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| BNP levels; hospital and long-term morbidity and mortality |  | BNP levels prior to surgery and at postoperative day 1; Hospital and long-term morbidity and mortality (1, 2 and 3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroScoreCardiac markers; inflammation markers; echocardiography |  | EuroScoreCardiac markers at day 1, 2, 5; Inflammation markers at day 1, 2, 5; Echocardiography (day 5, and 1, 2 and 3 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain natriuretic peptide, EuroScore, Cardiac surgery, Cardiopulmonary bypass, Coronary artery disease, Valvular disease, Risk stratification in cardiac surgery
Extended Long-Term Safety Study of KW-6500

Study Overview
=================
Brief Summary
-----------------
This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.

Official Title
-----------------
Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)

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

Intervention / Treatment
-----------------
* Drug: KW-6500


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have given written informed consent Patients who have completed the 6500-004 study

Ages Eligible for Study
-----------------
Minimum Age: 20 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: KW-6500<br> | Drug: KW-6500<br>* Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks<br>* Other names: Apomorphine hydroshloride (USAN);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and related adverse events |  | From first administration of study drug through Study Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS part III, response ratio, and UPDRS part II score |  | From first administration of study drug through Study Week 52 |
Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);

Official Title
-----------------
A Prospective, Single-arm, Phase II Study of Camrelizumab Combined With Pyrotinib Maleate, Nab-paclitaxel and Tegafur Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer

Conditions
-----------------
HER2-positive Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre Exclusion Criteria: rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

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: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur<br>Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14 | Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur<br>* Camrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR (Objective control rate) | The rate of CR and PR, determined using RECIST v1.1 criteria | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCR (Disease control rate) | The rate of CR, PR plus SD | up to 12 months | 
| PFS (Progression-Free survival) | From the date Into this study (signed ICF) to tumor progression or death for any | up to 12 months | 
| OS(Overall survival) | Baseline until death from any cause | up to approximately 24 months |
Collecting and Storing Blood and Tumor Tissue Samples From Patients Undergoing Prostatectomy or Transurethral Resection of the Prostate

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to collect material for study's to assess mechanisms of tumor progression, mechanisms of resistance, isolation of stem cells and biologic markers in tissue, serum and peripheral blood mononuclear cells.

Official Title
-----------------
Assessment of Tumor Resistance and Stem Cells in Prostate Cancer

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Undergoing routine prostatectomy or transurethral resection of the prostate (TURP) PATIENT CHARACTERISTICS: 5.1.1 Patient is undergoing routine prostatectomy or TURP. 5.1.2 Patient is ≥ 18 years old. 5.1.3 Patient must give informed consent. PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

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

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 |
| --- | --- | --- |
| Collection and freezing of tumor samples |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer
Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.

Detailed Description
-----------------
Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL). Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hCG administration.

Official Title
-----------------
Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch

Conditions
-----------------
Complications Associated With Artificial Fertilization, Disorder of Endocrine Ovary

Intervention / Treatment
-----------------
* Drug: Cabergoline and Hydroxyethyl Starch
* Drug: Hydroxyethyl Starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to be at risk of OHSS were invited to participate in the study Exclusion Criteria: age > 40 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Hemoes<br> | |
| Experimental: Cabergoline<br>cabergoline | Drug: Cabergoline and Hydroxyethyl Starch<br>* 0.5mg<br>* Other names: Dostinex;Drug: Hydroxyethyl Starch<br>* 0.5 mg cabergoline administration 8 days<br>* Other names: Hemoes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of ovarian hyperstimulation syndrome |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVF, ovarian hyperstimulation syndrome, cabergoline, hydroxyethyl starch, prevention