linjc16/ctgov huggingface dataset:
SDOCT-GMPE Software

Study Overview
=================
Brief Summary
-----------------
The investigators prospectively evaluate the new glaucoma premium edition (GMPE) software for spectral domain optical coherence tomography (SDOCT) and if this software is superior to the conventional one that is currently used for SDOCT.

Detailed Description
-----------------
The new GMPE software can now identify the ocular structures without input from the operator thus reducing operator induced errors. It also measures the thickness of the entire optic nerve head so as to allow for another anatomic area of the eye to be measured for assessment of glaucoma. In addition, it permits collection of retinal nerve fiber layer thickness data in three concentric circles instead of just one in order to account for different sizes of optic nerves. Subjects who are receiving routine SDOCT (CPT 92133) will be recruited from the Duke Eye Center and its associated satellite clinics. Following informed consent, subjects undergo additional imaging using the SDOCT-GMPE software at the Duke Eye Center and its associated satellite clinics. The imaging results may be used in clinical care for the subjects.

Official Title
-----------------
A Prospective Evaluation of the Novel Glaucoma Premium Edition Software for Spectral Domain Optical Coherence Tomography

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: SDOCT-GMPE software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: capable and willing to provide consent history of clinically-diagnosed glaucoma at least 18 years of age Exclusion Criteria: unable or unwilling to give consent under 18 years of age

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glaucoma arm<br>Consecutive patients with glaucoma will undergo non-invasive OCT imaging | Device: SDOCT-GMPE software<br>* Noninvasive imaging of the optic nerve in patients with existing glaucoma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW) | Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW). | imaging approximately 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OCT, glaucoma, spectral domain optical coherence tomography
Prospective Study of Undiagnosed Celiac Disease

Study Overview
=================
Brief Summary
-----------------
Direct benefits to the participants, who are diagnosed with celiac disease may be substantial and could include lessening or prevention of GI symptoms, correction of biochemical abnormalities and reduction in risk for malignancies or bone disease which are most common in untreated celiac disease. However, the precise benefit is unknown and the motivation for this proposed study. If these individuals have a positive celiac serology test at the present time there is a high likelihood that they may have celiac disease.

Official Title
-----------------
Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Other: Dietary instruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 60 years old Male and female Retrospective testing for celiac disease was done on previously stored serum. Contacting specific individuals for inclusion into study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary instruction on Gluten Free Diet<br> | Other: Dietary instruction<br>* Subjects subsequently diagnosed with celiac disease will have gluten-free diet instructions given by registered dietitian experienced in the gluten-free diet. Subjects will have follow-up in 3 months time from initial instruction to verify compliance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis | To understanding the impact of undiagnosed celiac disease and the potential benefits, detection and treatment may have a substantial impact on the health of these subjects and the large numbers of Americans with undiagnosed celiac disease. The outcome measures we will be looking at are Quality of Life, GI Symptoms including diarrhea, constipation, abdominal pain, Tissue Transglutaminase level improvement after 12 weeks on a gluten free diet, bone density, understanding of a gluten free diet. | one year |
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether the extract of the green tea is effective on obese women.

Detailed Description
-----------------
We conducted the pilot study in 2005. The initial findings showed the extract of green tea is benefit on obese women. The potential benefit include appetite lowing, lipid markers decreasing and regulating balance of obese related hormone peptides. So we designed this trial.

Official Title
-----------------
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

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

Intervention / Treatment
-----------------
* Drug: the extract of green tea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 16-60 years old female BMI>27㎞/m2 Signed informed consent Exclusion Criteria: Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder. Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker. Allergy and Immunology disease. High aminotransferases ( Alanine, Aspartate >80 IU/L) or high serum Creatinine (>2.5 mg/dL) Pregnant or lactating women. Childbirth within 6 months. Stroke or otherwise unable to exercise Management for weight control within 3 months. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: the extract of green tea|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Percent) reduction of body mass index and body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride |  |  | 
| leptin, adiponectin and ghrelin comparisons and analysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, green tea
Estimation of Preoperative Gastric Volume Using Ultrasound

Study Overview
=================
Brief Summary
-----------------
Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. The investigator examined the relationship between sonographic antral area and endoscopically suctioned gastric volumes infants.

Official Title
-----------------
Ultrasound Assessment of Gastric Volume in Infants Undergoing General Anesthesia: Validation Study

Conditions
-----------------
Fasting

Intervention / Treatment
-----------------
* Diagnostic Test: GUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants undergoing general anesthesia with endotracheal intubation were included in this study Exclusion Criteria: a recent (≤1 month) history of oesophageal or gastric surgery, gastrostomy or ileostomy, diaphragmatic hernia, emergent surgery, or a prolonged duration (>5 min) between completion of US assessment and suctioning of gastric contents

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GUS_infants<br>Infants patient undergoing general anesthesia for abdominal surgery | Diagnostic Test: GUS<br>* gastric volume estimation using gastric ultrasound was performed immediately after anesthetic induction, and after aspirating the residual gastric contents using nasogastric tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric antral cross sectional area | ultrasound assessment of gastric antral cross sectional area | immediate after anesthetic induction within 1 minutes. |
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss

Study Overview
=================
Brief Summary
-----------------
To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.

Official Title
-----------------
Double-Blind Placebo-Controlled Trial Of The Safety, Toleration and Efficacy Of Lasofoxifene 0.25 Mg/D and Raloxifene 60Mg/D For The Prevention Of Bone Loss In Postmenopausal Women

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: lasofoxifene
* Drug: raloxifene
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings Exclusion Criteria: Presence of metabolic bone disease, fractures, blood clots, or recent cancer. Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.

Ages Eligible for Study
-----------------
Minimum Age: 48 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasofoxifene 0.25 mg<br>lasofoxifene 0.25 mg/day | Drug: lasofoxifene<br>* lasofoxifene 0.25mg<br>|
| Active Comparator: raloxifene<br>raloxifene 60 mg/day | Drug: raloxifene<br>* raloxifene 60 mg/day<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 0 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spine BMD after 2 years | Lumbar Spine Bome Mineral Density | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year | Direct low density lipoprotein cholesterol (LDL-C) at 24 months, vaginal pH at 24 months, vaginal epithelial parabasal cells at 12 months, and total hip BMD at 24 months. | Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months |
Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to retrospectively evaluate associations between EGFR and AKT DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC patients treated with EGFR-TKIs.

Detailed Description
-----------------
DNA will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and SNPs genotyping will be done.

Official Title
-----------------
Relationship of Polymorphisms and Mutations of Epidermal Growth Factor Receptor and Tyrosine Kinase Inhibitors Responsiveness in Non-small-cell Lung Cancer Patients

Conditions
-----------------
NON-SMALL-CELL LUNG CANCER

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Availability of tumor tissue or blood samples. Diagnosis of NSCLC At least one treatment with EGFR-TKIs inhibitors Exclusion Criteria: Other than NSCLC primary diagnosis No treatment with EGFR-TKIs inhibitors No archival tissue available

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 |
| --- | --- | --- |
| to evaluate the presence of EGFR- and AKT-DNA polymorphisms. |  | At the end of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to correlate the biological characteristics with clinical characteristics and survival data of patients. |  | At the end of enrollment |
Hypnotherapeutic Olfactory Conditioning for Posttraumatic Stress Disorder (PTSD)

Study Overview
=================
Brief Summary
-----------------
Chronic combat-related posttraumatic stress disorder can be difficult to treat. The investigators believe that hypnosis, with a stress on the sensation of scent which often plays a role in the traumatic memories, can offer help for victims of this disorder who continue to suffer after receiving other treatments.

Detailed Description
-----------------
Our study examines the effect of hypnosis upon 36 individuals who suffer from posttraumatic stress disorder incurred in battles or training. The hypnotherapy stresses elements of odor, both in conditioning the subject to relate certain pleasant odors with security and calm, and in gradually reexposing the patient to the olfactory aspects of the traumatic memories. All subjects are taken form the Israel Defense Forces Mental Health Clinic, treated with 6 one-and-a-half-hour hypnotherapy sessions, and evaluated at baseline, end of treatment, after 6 months, and after 12 months, on a battery of clinical scales.

Official Title
-----------------
Hypnotherapeutic Olfactory Conditioning for Chronic Combat-Related Posttraumatic Stress Disorder

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Hypnotherapeutic Olfactory Conditioning (HOC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of chronic combat-related PTSD according to DSM-IV criteria (APA, 1994), as determined by semi-structured psychiatric interview conducted by a psychiatrist with over ten years of experience treating PTSD Flashbacks and/or panic attacks with olfactory components Prior attempt at treatment with unsatisfactory results Competence and agreement to sign an informed consent. Exclusion Criteria: Evidence of psychosis Severe traumatic brain injury Post-concussion syndrome Uncontrolled substance abuse.

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Hypnotherapeutic Olfactory Conditioning (HOC)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Event Scale |  | Baseline, 6 weeks, 6 months, one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | Baseline, 6 weeks, 6 months, one year | 
| Dissociative Experience Scale |  | Baseline, 6 weeks, 6 months, one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypnotherapy, Hypnosis, PTSD
Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

Study Overview
=================
Brief Summary
-----------------
Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients

Official Title
-----------------
Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: Nexavar (Sorafenib, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Advanced histological or cytological documentation of cancer life-expectancy of at least 12 weeks able to swallow pills ECOG status of 0,1 or 2 adequate bone marrow liver and renal function Exclusion Criteria: > NYHA Class 2 CHF Serious myocardial dysfunction, or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed) History of organ allograft uncontrolled hypertension renal dialysis Bleeding event/hemorrhage within 4 weeks of study treatment major surgery within 4 weeks of study treatment Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Nexavar (Sorafenib, BAY43-9006)<br>* Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Sorafenib, Cyclophosphamide, Doxorubicin
China Senile Valvular Heart Disease Cohort Study

Study Overview
=================
Brief Summary
-----------------
Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.

Official Title
-----------------
Multicenter Prospective Cohort Study of Senile Hospitalized Patients With Valvular Heart Disease

Conditions
-----------------
Heart Valve Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients over 60 years old meet one of the following conditions. moderate or above valvular heart disease as defined by echocardiography: aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, mitral stenosis, moderate or above, or valve area ≤2.0cm2, mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, pulmonic stenosis, moderate or above, or maximal jet velocity >4m/sec, pulmonic regurgitation, moderate or above, or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation), or diagnosis of endocarditis as assessed by Duke criteria. Exclusion Criteria: Patients cannot be followed up for any reasons. Patients in critical condition may be die in the near future. Patients have been enrolled in this study.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| all cause mortality |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Valve Diseases, Cardiovascular Diseases, Heart Disease, Valvular Heart Diseases