linjc16/ctgov huggingface dataset:
Long-Term Safety of Symbicort in Asthmatic Children - SAPLING

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

Official Title
-----------------
A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol (Symbicort)
* Drug: budesonide (Pulmicort)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 6 and maximally 11 years of age Diagnosis of asthma Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start Exclusion Criteria: Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 11 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 |
| --- | --- |
| Experimental: 1<br>budesonide/formoterol | Drug: budesonide/formoterol (Symbicort)<br> <br> * Other names: Symbicort;|
| Active Comparator: 2<br>budesonide | Drug: budesonide (Pulmicort)<br> <br> * Other names: Pulmicort;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol |  | 4 assessments within 26 week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort |  | 4 assessments within 26 week treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, children, Symbicort, budesonide/formoterol, Pulmicort, budesonide
Elastography as Gouty Arthropathy Outcome (EGO)

Study Overview
=================
Brief Summary
-----------------
Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.

Detailed Description
-----------------
Pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.

Official Title
-----------------
Elastography as Gouty Arthropathy Outcome (EGO), a Pilot Study.

Conditions
-----------------
Gout

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are at least 18 years of age but younger than or equal to 99 years of age. Subjects with gouty arthritis as determined by the ACR 1977 classification criteria for gouty arthritis. Subjects with one palpable tophus detectable by one of the three clinical parameters described. - Exclusion Criteria: Subjects who are not eligible for urate lowering treatment or show a hypersensitivity to these drugs or class of compounds. Subjects with significant cardiovascular, neuropsychiatric, hematologic, hepatic, renal or endocrine dysfunction who in the opinion of the principal investigator are unfit for participation in a clinical trial. Subjects for which the clinical and laboratory assessment would provide undue discomfort and / or are contraindicated. -

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 |
| --- | --- | --- |
| Elastography as Gouty Arthropathy Outcome (EGO), a pilot study | Observational trial to measure gouty arthritis changes in subject taking urate lowering therapies | 1 year |
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.

Official Title
-----------------
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

Conditions
-----------------
Short Stature

Intervention / Treatment
-----------------
* Drug: Growth Hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ability to provide written informed consent Prepubertal males and females form 5- 11years old Bone age <11 years in males and <9 years in females Height SD score<-2.25SD in males and females IGF-1SD score <-1SD in both males and females Peak GH level after stimulation >10ng/ml Exclusion Criteria: History of prior chemotherapy and or radiation Active neoplasm Pediatric patients with closed epiphyses Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly Treatment with inhaled or systemic steroids BMI <5th percentile or >95th percentile Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This study was changed to a retrospective chart review. There was no prospective component.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth hormone, injections<br>Growth hormone injection 0.3mg/kg/week dailY | Drug: Growth Hormone<br>* Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months<br>* Other names: Nutropin AQ;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Outcome measurement | Growth velocity after treatment with appropriate growth hormone doses | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IGF-1, Short Stature, GH
Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Sickle Cell Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate patients with pulmonary hypertension and sickle cell disease who have had multiple echocardiograms. Previous studies have shown that an elevated tricuspid jet (TR) regurgitant velocity on echo in this population is a predictor of mortality. This initial data only examined an isolated TR jet velocity. It was presumed that the mortality was related to pulmonary hypertension. It is the aim of this study to retrospectively evaluate patients who have had multiple echocardiograms and to determine if patients who had either a normalization of their TR jet velocity on a subsequent echo or had no evidence of pulmonary hypertension on right heart catheterization had a similar mortality rate to those with persistently elevated TR jet velocity.

Official Title
-----------------
An Evaluation of Tricuspid Regurgitant Jet Velocity as an Independent Marker for Mortality in Patients With Sickle Cell Anemia: A Retrospective Data Review

Conditions
-----------------
Sickle Cell Anemia, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
To limit bias in this study all patients that with sickle cell anemia and pulmonary hypertension with the pre-specified data required will 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sickle cell and pulmonary hypertension<br> | Other: Data Collection<br>* Collection of data from existing medical records<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective review on patients who have had multiple echocardiograms to determine if patients with a normalization of TR Jet Velocity have changes in risk of death compared with those who do not have normalization of TR Jet Velocity. | Any subject's who meet criteria and have multiple echocardiograms may be included. | Up to 20 years |
Effective Use of Respiratory Patterns in the First Period of Labor in Control of Maternal Anxiety

Study Overview
=================
Brief Summary
-----------------
The effectiveness of breathing exercise on anxiety in women during the first period of labor.

Detailed Description
-----------------
The groups will be randomized into intervention groups, which will be held ventilatory patterns while the control group will receive routine care service. The measurements will be made during the admission, and every 2 hours until the final phase of dilation.

Official Title
-----------------
EFFECTIVE USE OF RESPIRATORY PATTERNS IN THE FIRST PERIOD OF LABOR IN CONTROL OF MATERNAL ANXIETY: A CLINICAL TRIAL

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: Respiratory pattern


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous First stage of labor Exclusion Criteria: Multiple gestation; Eclampsia; Pregnancy with a dead fetus; Use of analgesia; Pregnant women with clinical instability; Psychiatric disorders;

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: respiratory pattern<br>Deep and slow inspiration is used in the initial and active stages, at which time the contractions vary from uncomfortable to strong, lumbosacral pain and cervical dilation may occur between 3 and 8 cm in this case the mother is driven to inspire slowly and the level of inspiratory reserve volume followed by slow exhalation to functional residual capacity; Sigh with post-expiratory pause that corresponds to a small spontaneous exhalation to relax occurs in tidal volume; Expiratory delay that corresponds to a prolonged propelled with the lips during the lull and expiration in the expiration time that corresponds to a slow inspiration followed by two or three puffs with the short lips will be used propelled. | Other: Respiratory pattern<br> <br> |
| No Intervention: Control<br>Follows the service routine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | The anxiety of patients will be assessed using IDATE questionnaire | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, breathing exercise, labour
Vitamin D Level in Recurrent PV

Study Overview
=================
Brief Summary
-----------------
Serum Samples will be taken from patients with recurrent Pityriasis Versicolor for the evaluation of vitamin D level.

Official Title
-----------------
Serum Vitamin D Level Detection in Patients With Recurrent Pityriasis Versicolor

Conditions
-----------------
Recurrent Pityriasis Versicolor

Intervention / Treatment
-----------------
* Diagnostic Test: Human 25-Hydroxyvitamin D3 (HVD3) ELISA Kit (96 well)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with recurrent pityriasis versicolor (active now) and not taking treatment for it. Patients of both genders. Age ≥18 years old. Exclusion Criteria: - Patients with other cutaneous diseases. Patient's having dandruff (scaly scalp) even if not symptomatizing. Pregnant and lactating females, children, prisoners, cognitively impaired or mentally disabled subjects. Patients with autoimmune diseases. Patients with immunodeficiency diseases. Immunosuppressed patients e.g. HIV, diabetics, organ transplant, malignancy, patients taking immunosuppressive drugs e.g. chemotherapy, cortisone.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>recurrent pityriasis versicolor | Diagnostic Test: Human 25-Hydroxyvitamin D3 (HVD3) ELISA Kit (96 well)<br>* The serum will be tested by a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to assay the level of Human 25Dihydroxy vitamin D（25-OH-D).<br>|
| Controls<br>Healthy age and sex matched | Diagnostic Test: Human 25-Hydroxyvitamin D3 (HVD3) ELISA Kit (96 well)<br>* The serum will be tested by a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to assay the level of Human 25Dihydroxy vitamin D（25-OH-D).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25(OH) D3 level | The serum of patients and controls will be tested by a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to assay the level of Human 25Dihydroxy vitamin D（25-OH-D). | 6months-1 year |
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.

Study Overview
=================
Brief Summary
-----------------
This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.

Detailed Description
-----------------
This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be administered using a dose escalating scheme.

Official Title
-----------------
A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.

Conditions
-----------------
Glioma, Brain Neoplasm

Intervention / Treatment
-----------------
* Drug: 131I-TM-601


Participation Criteria
=================
Eligibility Criteria
-----------------
Patient must have given informed consent Patient must have histologically confirmed supratentorial malignant glioma Patients must have recovered from toxicity of prior therapy Patients must be eligble for resection of the recurrent tumor

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 131I-TM-601|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
-----------------
Brain neoplasm, Clinical trial, phase I/II
Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Study Overview
=================
Brief Summary
-----------------
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Conditions
-----------------
Aortic Valve Stenosis, Heart Valve Disease

Intervention / Treatment
-----------------
* Other: 4-dimensional volume-rendered computed tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implanted with a sutureless Perceval (Sorin Group) sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016 Provide written informed consent Exclusion Criteria: Contraindication for CT with intravenous contrast injection

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 4-dimensional volume-rendered computed tomography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced aortic valve leaflet motion |  | At CT performed once no less than 30 days and up to 10 years after aortic valve replacement |
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.

Official Title
-----------------
Single-Dose Fed In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Olmesartan Medoxomil Tablets 40 mg
* Drug: Benicar® Tablets 40 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olmesartan Medoxomil Tablets 40 mg | Drug: Olmesartan Medoxomil Tablets 40 mg<br>* 40mg, single dose fed<br>|
| Active Comparator: 2<br>Benicar® Tablets 40 mg | Drug: Benicar® Tablets 40 mg<br>* 40mg, single dose fed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 48 hours |
Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Due to various causes, such as brain impairment, environment changes, anxious,et al. patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In chinese traditional medicine, acupuncture can improve the quality of sleep in patients with sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients with heart operations.

Detailed Description
-----------------
60 patients are divided into three groups. control group: no any intervention; experiment group 1: acupuncture are used in patients before cardiac operation; experiment group 2: acupuncture are used through all the course in hospital. before operation, before discharge, one month after operation, two month after operation, the quality of sleep are evaluated. and comparisons will be made in three groups.

Official Title
-----------------
Study of Acupuncture of Traditional Chinese Medicine

Conditions
-----------------
Heart Valve Diseases, Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Other: electronic acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aging:18yr--65yr cardiopulmonary bypass NYHA ≤II and EF≥50% not illiterate person Exclusion Criteria: neurological disease,mentality disorder abuse of alcohol long history of smoking sleep disorder before admitting to hospital

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br> | Other: electronic acupuncture<br>* applying a stimula on neiguang and shenmen through electronic acupuncture<br>|
| Active Comparator: acupuncture preoperative<br>acupuncture before operation for one week | Other: electronic acupuncture<br>* applying a stimula on neiguang and shenmen through electronic acupuncture<br>|
| Active Comparator: acupuncture in hospital<br>acupuncture all the time in hospital | Other: electronic acupuncture<br>* applying a stimula on neiguang and shenmen through electronic acupuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| multiple monitoring for sleeping |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary bypass, sleep, acupuncture