linjc16/ctgov huggingface dataset:
Clinical Study of Anti-tumor Necrosis Factor Therapy in Patients With Takayasu Arteritis

Study Overview
=================
Brief Summary
-----------------
Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis. This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11

Detailed Description
-----------------
Clinical study of anti-tumor necrosis factor therapy in patients with Takayasu arteritis. This study is single arm (anti Tumor necrosis factor therapy only) clinical trial. Enrolled patients will be 11 patients with active takayasu's arteritis

Official Title
-----------------
Anti-tumor Necrosis Factor Therapy Effect on Takayasu Arteritis

Conditions
-----------------
Takayasu's Arteritis

Intervention / Treatment
-----------------
* Drug: remicade (anti tumor necrosis factor inhibitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active takayasu's arteritis Exclusion Criteria: active Tuberculosis Liver function abnormality heart failure ( New York Heart Association III - IV) patients were not consented

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>anti Tumor necrosis factor treatment group : treatment with remicade 5mg/kg as scheduled (0, 2, 6, 14, 22, 30, 38, 46, 54weeks). evaluation of response at 30weeks by PET CT, acute phase reactants, symptom No placebo group | Drug: remicade (anti tumor necrosis factor inhibitor)<br>* single arm:remicade treatment group<br>* Other names: remsima;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission induction at 30 weeks |  | 30 weeks |
Genioglossus Strength and OSAS

Study Overview
=================
Brief Summary
-----------------
Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive

Detailed Description
-----------------
To describe by statistical analysis the normal distribution domain of genioglossus muscle strength in each of the four clinical stages of Sleep Apnea; and, by regression analysis, to explore the possibility of an inverse relationship between decreasing genioglossus strength and progression of the clinical stages of OSAS. 1.3. To test the hypothesis that a subpopulation of subject exists within the clinical spectrum of OSAS, in whom decreasing strength of the genioglossus muscle may represent a common element in spite of differing possible pathophysiologic pathways leading to Obstructive Sleep Apnea in man. 1.4. The major hypothesis of this proposal is thus that Genioglossal Strength is inversely correlated with Obstructive Sleep Apnea Pathology.

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-40 years inclusive BMI 18-25 Non-smoking history and no current use for a minimum of 6 months No smokeless tobacco products (including e-cigarettes) for a minimum of 6 months No sleep snoring reported by subject and by bedroom companion Self-described as active/athletic (i.e. regular hikes, walks, jogging, running, active Sports, such as volleyball, soccer, etc.) Self-described as healthy, with no known disease or recent illness Self-completed Epworth Sleepiness Scale of <6 (Johns, MW, A new method for Measuring daytime sleepiness: the Epworth Sleepiness Scale; SLEEP 14:450-5, 1991). Physical Examination Mallampati Score of Class 1 (Nuckton, TJ, et al: Physical Examination: Mallampati Score as an Independent Predictor of OSAS; SLEEP 29: 903-908, 2006). Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| OSAS subjects<br>CPAP Referral OSAS | |
| Risk-Free subjects<br>paired normal control subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genioglossal Strength | quantitative measurement of tongue strength | single clinic visit |
Thrombospondin-1 and Pigmented Epithelium Derived Factor Levels in Patients With Diabetes Mellitus.

Study Overview
=================
Brief Summary
-----------------
You are being asked to be in a research study to determine blood levels and vitreous levels of compounds called thrombospondin 1 (TSP1) and pigment epithelium derived factor (PEDF). These compounds exists naturally in your body.

Detailed Description
-----------------
The hypothesis tested here is that diabetic patients that express the higher molecular weight pigment epithelium-derived factor (PEDF) isoform have lower thrombospondin-1 (TSP1) level and, as a result, are at a greater risk for the development of more severe diabetic retinopathy.

Official Title
-----------------
Modulation of Thrombospondin-1 and Pigment Epithelium Derived Factor Levels in Vitreous Fluid and Plasma of Patients With Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus

Intervention / Treatment
-----------------
* Biological: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Diabetes Mellitus Undergoing pars plana vitrectomy for any reason Exclusion Criteria: Use of any anti-VEGF (vascular endothelial growth factor ) medications

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Blood draw<br>Blood (approximately equal to 3 to 4 tablespoons) will be drawn at the Wills Eye Institute, 1 time. | Biological: Blood draw<br>* 3-4 tablespoons of blood will be drawn, one time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of thrombospondin (TSP1) and pigment epithelium derived factor (PEDF) in the vitreous and plasma | Your voluntary participation in this study may help determine how different TSP1 and PEDF levels correlate with diabetic eye disease. | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEDF, TSP1, Thrombospondin, pigment epithelium derived factor, Wills Eye Institute, Pars plana vitrectomy, Vitreous levels, Mid Atlantic Retina, Blood draw, Blood test
Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fed conditions.

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Bioequivalency Study of Exemestane 25 mg Tablets Under Fed Conditions

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: exemestane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to exemestane or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: exemestane|25 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 21 days |
Study of Arbaclofen for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in subjects with autism spectrum disorders

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects With Autism Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorders

Intervention / Treatment
-----------------
* Drug: Arbaclofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Autism Spectrum Disorders (ASD) Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening. Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics. If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening Exclusion Criteria: Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. Subjects who have taken another investigational drug within the last 30 days. Subjects who are not able to take oral medications

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 21 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | |
| Active Comparator: Arbaclofen<br> | Drug: Arbaclofen<br> <br> * Other names: STX209, R-baclofen;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist-Social Withdrawal Subscale |  | At 8 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASD, Autism, Asperger Syndrome
Vitamin D of Chinese Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess the vitamin D status and analyze risk factors for vitamin D inadequacy of Chinese children and adolescents aged 6-17y.

Detailed Description
-----------------
In this study, we analyzed the vitamin D status of Chinese children and adolescents aged 6-17y, and related risk factors (such as gender, region strata, ambient UVB level at area of residence, season, and outdoor time, etc.). Serum 25 hydroxyvitamin D [25(OH)D] was measured with a radioimmunoassay kit in 15 000 children and adolescent participants in Chinese national nutrition and health survey (CNNHS) 2010-2012. Age, gender, region type, ethnicity, outdoor time, vitamin D supplementation were recorded in unified design questionnaires. Season was recorded by the date of blood taken; location was divided into north and south by China's Qinling mountains and Huaihe river; and ambient ultraviolet B (UVB) radiation level was classified according to the corresponding dose of each participant living area from National Aeronautics and Space Administration data.

Official Title
-----------------
Vitamin D Nutritional Status and Its Related Factors for Chinese Children and Adolescents in 2010-2012

Conditions
-----------------
Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participanted in China national nutrition and health survey (CNNHS) 2010-2012; Aged 6-17 years; Had blood taken; Exclusion Criteria: No.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| 25 hydroxyvitamin D | To describe the vitamin D status,ng/mL. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data | age, gender, ethnicity | through study completion, an average of 1 year | 
| Environmental data | season,region type, latitude, ambient ultraviolet B radiation level | up to 25 weeks | 
| Outdoor time | outdoor activity time | through study completion, an average of 1 year | 
| Vitamin D supplementation | frequency of vitamin D supplements taking for each participant | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
25 hydroxyvitamin D, 6-17 years old, vitamin D deficiency
Blood Flow Change After Free Flap Surgery in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
We aim to evaluate the flow change of arterial anastomosis site during free flap surgery in diabetic patients.

Detailed Description
-----------------
Objective: flow change of arterial anastomosis site during free flap surgery in diabetic patients. Background: No research was published about flow change of arterial anastomosis site of the free flap during surgery. Plan: Using Duplex sonography, various parameters related flap perfusion will be evaluated before and after the administration of alprostadil.

Official Title
-----------------
Prospective Observational Study of the Changes of Blood Flow of Arterial Anastomosis-site of Free Flap in Diabetic Patients Who Undergoing Free Flap Transfer

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Drug: Alprostadil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Plan to receive free flap transfer under general anesthesia Age: >=18 and <80 years old History of diabetes mellitus Administration of alprostadil during surgery Volunteer, who are provided written informed consent prior to study participation Exclusion Criteria: Refuse the participation of study >= American society of anesthesiologist physical status IV Use of any vasopressor or inotropic for hemodynamic instability before participation of study Inappropriate subjects who are identified by researchers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alprostadil|Vasodilator for anastomosis-site of free flap|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow change | Peak velocity of anastomosis-site of free flap | before alprostadil administration, 30 mins after alprostadil administration |
Comparison of Laparoscopic Nissen Versus Thal Fundoplication in Children

Study Overview
=================
Brief Summary
-----------------
Laparoscopic fundoplication is increasingly performed in paediatric surgery. Many types of fundoplication are performed, each has advantages and disadvantages. The Nissen operation is the most frequently performed procedure in the U.K., however it can be associated with post-operative dysphagia. The relative benefits between Nissen and other fundoplication techniques in children are still uncertain. The aim of our study was to compare the long-term outcomes following laparoscopic Nissen fundoplication with laparoscopic Thal fundoplication in children.

Official Title
-----------------
Long-term Outcome of Laparoscopic Nissen Fundoplication Compared With Laparoscopic Thal Fundoplication in Children

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Procedure: laparoscopic Nissen/laparoscopic Thal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastro-oesophageal reflux unresponsive to medical treatment, or those who had serious complications (e.g. apnoea, aspiration pneumonia, oesophagitis) Exclusion Criteria: Patients who had previous anti-reflux surgery, previous open abdominal surgery, if parents declined to participate into study

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic Nissen/laparoscopic Thal|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of symptoms sufficiently severe to justify the need for additional revisional surgery (i.e. failure of the original surgery) |  |  | 
| Early death following surgery directly related to the fundoplication technique |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The resumption of symptoms bad enough to necessitate the re-introduction of anti-reflux medication (but not sufficiently bad to require revisional surgery) i.e. intention to treat |  |  | 
| Post-operative complications (e.g. post-operative dysphagia) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopy, fundoplication, Nissen, Thal, children, operative treatment of gastro-oesophageal reflux disease in children
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance.

Official Title
-----------------
A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Device: Middle Turbinate Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery. Subject is able to provide a signed informed consent form. Subject will agree to comply with all study-related procedures. Subject is not pregnant at this time by confirmation of one of the following: Subject is male Subject not of child bearing age Subject is surgically sterile Subject is not pregnant per negative hCG test Subject does not plan on becoming pregnant and is not breast feeding during the course of the study. Exclusion Criteria: Subject does not meet inclusion criteria. Presence of non-viable tissue at the implantation site. History of septal perforation. History of polyps. Presence of concha bullosa. Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea. Subject is participating in a clinical trial which could affect the healing of the middle turbinate. Subject has uncontrolled diabetes. Subject is a: smoker severe drug abuser severe alcohol abuser Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Middle Turbinate Implant<br>Subjects to receive Middle Turbinate Implant | Device: Middle Turbinate Implant<br>* Middle Turbinate Implant placement at time of surgery and follow ups.<br>* Other names: MTI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance of the MTI |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual tissue reaction to the Middle Turbinate Implant |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
turbinate, implant, sinus surgery, Turbinates