linjc16/ctgov huggingface dataset:
A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China

Study Overview
=================
Brief Summary
-----------------
Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. So, the investigators designed the study for the following purposes: 1, to aware the incidence of infantile hemangioma and understand the related risk factorsin China; 2, to understand the clinical characteristics of infantile hemangioma and the risk factors for complications; 3, to investigate the level of knowledge, treatment options in infant hemangioma in Chinese doctors; 3, to improve the awareness of infantile hemangioma in parents and provide more advice for pregnancy counseling and eugenics.

Official Title
-----------------
A Prospective Study on the Incidence and Related Risk Factors of Infantile Hemangioma in China

Conditions
-----------------
Infantile Hemangioma, Capillary Hemangioma, Capillary Hemangiomas, Hemangioma, Capillary Infantile, Strawberry Hemangioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese The infants within 12 months of age Exclusion Criteria: Those whoes guardian does not want his data to be collected in this study

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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 |
| --- | --- |
| Infant hemangioma(IH)<br>Infant hemangioma(IH) is the most common benign vascular tumor of infancy with the estimated incidence varies 1% to 12%.However, in China, the incidence of infant hemangioma and related epidemiological data remains unclear. So, We designed the study to collect data about both epidemiology related risk ractors of infantile hemangioma in China. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of infantile hemangioma in China | Data collected by questionnaire of infantile hemangioma, filled by the investigators | about 1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemangioma
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris

Official Title
-----------------
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: CTLA4Ig / Abatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration. vulgaris total body surfae area involvement of at least 10% Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate. Exclusion Criteria: Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study. Functional class (V (ACR) RA or amyloidosis) Active vasculitis (except for subcutaneous rheumatoid nodules). Subjects with a history of asthma, angioedema or anaphylaxis. Subjects with evidence of active or latent bacterial or viral invedtions. Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma). body weight > 100 kg (or 220 lbs.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CTLA4Ig / Abatacept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index. |  |  |
The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the insulin-like growth factor (IGF) axis involvement in the immune tumor microenvironment in ovarian cancer.

Official Title
-----------------
The IGF Axis Involvement in Immune Tumor Microenvironment in Ovarian Cancer and Its Clinical Significance

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Other: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women diagnosed with epithelium ovarian cancer who have undergone surgery Exclusion Criteria: Pregnant women

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovarian cancer patients<br>Biopsy will be taken from ovarian cancer patients and sent to laboratory for analysis | Other: Biopsy<br>* Biopsy taken during surgical procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Involvement of IGF Axis in Ovarian Cancer | Ovarian cancer specimens taken during surgical procedures will be evaluated and analyzed by flow cytometry assays to determine the involvement of the IGF axis in the immune tumor microenvironment in ovarian cancer | Two years |
Prevalence and Reversibility of Lung Hyperinflation in Asthma

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.

Detailed Description
-----------------
The other objectives are : the evaluation of the hyperinflation defined by an increase of the residual volume (RV), the observation of the relationship between the hyperinflation and the asthma characteristics, the study of the improvement of the functional parameters after a reversibility test the evaluation of the correlation between hyperinflation parameters evolution, chest tightness and dyspnea

Official Title
-----------------
Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of uncontrolled persistent asthma (ACT </= 19) or with an MRC score of dyspnea >/= 1 Patient requiring a check-up including a pulmonary function test by plethysmography with a reversibility test Exclusion Criteria: Patient participating to an other clinical trial or having participated to a clinical trial with medicine in the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Distal Airways, Hyperinflation, Reversibility
Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers

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

Intervention / Treatment
-----------------
* Drug: Test formulation
* Drug: Reference formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease Exclusion Criteria: History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease; Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests; Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication; Use of any substance that could induce or inhibit drug metabolism enzymes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test and reference formulations<br>Test formulation and reference formulation given orally 14 days apart in a fasted state | Drug: Test formulation<br>* A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg<br>Drug: Reference formulation<br>* A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | Cmax, Area Under Curve(0 to the last sampling time) | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | Tmax, Area Under Curve(0 to infinity), T_1/2 | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics
Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.

Official Title
-----------------
An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Subjects With Schizophrenia or Schizoaffective Disorder

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

Intervention / Treatment
-----------------
* Drug: NSA-789
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Men or women of non childbearing potential (WONCBP) aged 18 to 50 years, inclusive. Currently under the care of a physician for psychiatric illness. Clinical diagnosis of schizophrenia or schizo affective disorder in the opinion of the study psychiatrist based on review of all available clinical data. Exclusion: Any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NSA-789<br>Active study drug | Drug: NSA-789<br> <br> |
| Placebo Comparator: Placebo<br>Inactive study drug | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability as measured through the reporting of adverse events; Pharmacokinetic as measured by the concentrations of NSA-789 in blood; Pharmacodynamics as measured by the results of psychiatric ratings and neurologic evaluations. |  | 6 months |
Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
A Study to determine if a high-fat meal has an effect on the pharmacokinetics of bosutinib.

Official Title
-----------------
An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Bosutinib Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Bosutinib
* Drug: Bosutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men, age 18-50; Healthy women of nonchildbearing potential, age 18-50. Exclusion Criteria:

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bosutinib fasting | Drug: Bosutinib<br>* Bosutinib fasting<br>|
| Experimental: 2<br>Bosutinib fed | Drug: Bosutinib<br>* Bosutinib fed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (plasma concentrations) |  | 4 weeks |
Esophageal Motility Disorders in Patients With Non-cardiac Chest Pain at Assiut University Hospital

Study Overview
=================
Brief Summary
-----------------
to determine the prevalence and distribution of esophageal motility disorders in NCCP patients who presented after a negative cardiac evaluation and underwent esophageal manometry, esophageal pH monitoring

Detailed Description
-----------------
Non-cardiac chest pain (NCCP) is defined as recurrent anginalike pain without evidence of cardiac disease [1]. NCCP is a common disorder and accounts for 14-33% of patient visits to gastroenterologists [2]. These patients frequently undergo testing for reflux and esophageal motility as gastroesophageal reflux disease (GERD) is seen in 50-60% and esophageal motility disorders in 15-18% of the patients [3,4]. Nutcracker esophagus was thought to be the classic manometric finding in NCCP [5] but other studies have reported ineffective esophageal motility (IEM) as the most common motility disorder in NCCP [6,7]. Furthermore, up to one-third of patients do not have any GERD or motility disorders and are labeled as functional chest pain [8]. Suggested causes in these patients include esophageal hypersensitivity [9], abnormal cerebral pain processing and psychological comorbidity [10]. The clinical predictors of abnormal esophageal function tests in NCCP have not been identified. Identifying these factors would lead to limited use of testing in those with risk factors and faster institution of pain modulator therapy in patients who are most likely to have functional chest pain.

Official Title
-----------------
Esophageal Motility Disorders in Patients With Non-cardiac Chest Pain at Assiut University Hospital

Conditions
-----------------
Esophageal Motility Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: upper endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years Patients presented with non-cardiac chest pain Exclusion Criteria: 1- age below 18. 2- cardiac chest pain patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: upper endoscopy|detect esphageal motility disorder by upper endoscopy and esophageal manometry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esophageal motility disorders in patients with non-cardiac chest pain at Assiut University hospital | Determine esophageal motility disorder in patient with non cardiac chest pain using ECG ,cardiac enzymes and echocardiography , esophageal manometry and upper endoscopy | one year |
Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis

Study Overview
=================
Brief Summary
-----------------
The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass grafting.

Detailed Description
-----------------
Using contemporary statistical method the cardiac index values obtained via uncalibrated pulse contour analysis with Pro AQT system will be compared with traditional transpulmonary thermodilution technique (Pulsion, Germany).

Official Title
-----------------
Evaluation of Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis During Off-pump Coronary Artery Bypass Grafting

Conditions
-----------------
Cardiac Index

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective off-pump coronary artery bypass grafting Exclusion Criteria: age < 18 and > 80 years, preoperative ejection fraction < 0.35, severe cardiac valve dysfunction or peripheral vascular disease, constant atrial fibrillation, simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.), transfer to cardiopulmonary bypass.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Validity of cardiac index measurement | Accuracy and precision of cardiac index measurement using uncalibrated pulse contour analysis in comparison with transpulmonary thermodilution | Up to 24 hrs post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac index, coronary artery bypass, uncalibrated pulse contour analysis, hemodynamic monitoring
Diagnostic Possibilities in Ophthalmological Diseases Using Swept Source Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
In this pilot study we want to investigate morphological features acquired by the novel image modality and gain information regarding disease pathomechanism, development and future possible influence on disease management for patients affected by those diseases.

Official Title
-----------------
Diagnostic Possibilities in Ophthalmological Diseases Using Swept Source Optical Coherence Tomography

Conditions
-----------------
Retinal Disease, Diabetic Retinopathy, Macular Degeneration

Intervention / Treatment
-----------------
* Diagnostic Test: SS-OCT system Plex Elite 9000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 5 and 110 years Ability to follow instructions during imaging procedure Written Informed consent Exclusion Criteria: Dementia Inability to follow instructions during imaging procedure Patients who do not give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 110 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: SS-OCT system Plex Elite 9000|We will use a commercially available SS-OCT system (Plex Elite 9000; Carl Zeiss Meditec).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphological changes using Swept Source Optical Coherence Tomography | Morphological changes in retinal diseases provided by Swept Source Optical | through study completion, an average of 1 year |