linjc16/ctgov huggingface dataset:
SUMCO Metabolic Syndrome Project

Study Overview
=================
Brief Summary
-----------------
Physical activity is considered important in prevention and treatment of obesity and metabolic syndrome. Genotype of genes involved in metabolism is also known to be associated with the development of metabolic syndrome. However, scarce evidence exists regarding the influence of physical activity intensity and genotype on metabolic syndrome in people with obesity. The investigators examine physical activity using an uniaxial accelerometer, as well as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who were employees in silicon wafer manufacture and participated in a health checkup.

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy people and individuals with obesity and metabolic syndrome Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle modification<br> | Other: exercise training<br>* exercise class once a year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Components of metabolic syndrome |  | every year |
Safety of a New Type of Treatment Called Gene Transfer for the Treatment of Severe Hemophilia B

Study Overview
=================
Brief Summary
-----------------
In this study a modified virus called adeno-associated virus (AAV) will be used to transfer a normal gene for human clotting factor IX into patients with severe hemophilia B (AAV human Factor IX vector). Gene therapy is a very new medical technique being used in a number of clinical studies for diseases such as cancer and cystic fibrosis. At this time, the U.S. Food and Drug Administration has approved no gene transfer products for commercial use. To date, 8 subjects have received AAV vector in the muscle for a hemophilia B trial by intramuscular injection, and, to date, 6 subjects have been treated with AAV vector in the current hemophilia B liver trial. Eleven cystic fibrosis subjects have received AAV vector into their nasal sinuses or lungs to date. In this study, AAV human Factor IX vector will be injected into the liver using a catheter inserted into a large blood vessel (called the proper hepatic artery or the right hepatic artery).

Official Title
-----------------
A Phase I Safety Study in Subjects With Severe Hemophilia B (Factor IX Deficiency) Using Adeno-Associated Viral Vector to Deliver the Gene for Human Factor IX Into the Liver

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Genetic: Adeno-Associated Viral with Human Factor IX


Participation Criteria
=================
Eligibility Criteria
-----------------
Males with severe hemophilia B with Factor IX activity level < 1% of normal. Life expectancy of > 1 year. Age > 18 years old. Ability to give informed consent. Greater than twenty exposure days of treatment with Factor IX protein. No history or presence of an inhibitor to Factor IX protein. Subjects must be able to receive Factor IX protein on a home infusion protocol. Subjects must have a normal protime (PT). Hepatitis C infected subjects will be evaluated for liver fibrosis based on liver biopsy data graded on a scale of 0-4 (Poynard et. al., 1997). Subjects who are Hepatitis C antibody and RNA positive and have not had a liver biopsy within the last 36 months will be required to have one. Subjects must have low AAV titer.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Adeno-Associated Viral with Human Factor IX|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
-----------------
Hemophilia B, Factor IX, Gene Transfer, Adeno-Associated Virus (AAV)
Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The research and development of novel anti-tumor agents in oral cancer is slow, the investigation of repositioning use of currently available drugs in clinical, such as a selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential alternative strategy.

Detailed Description
-----------------
Celebrex (Celecoxib) is a form of non-steroidal anti-inflammatory drug that directly targets COX-2 enzyme to block the inflammatory signaling and has been approved to treat colon cancer. In our preliminary findings, Celecoxib significantly inhibited cell growth,proliferation, migration, invasion and epithelial-mesenchymal transition programs in oral squamous cell carcinoma cell (OSCC) lines. The Institutional Review Board in China Medical University Hospital (CMUH) has approved the combination treatment of concurrent radiotherapy (RT) and/or Cisplatin with or without Celecoxib in a phase II clinical trial for relapse-free primary OSCC patients.

Official Title
-----------------
Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer

Conditions
-----------------
Oral Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OSCC patients with T1,2/ N0 and without pathological risk features OSCC patients with T1,2/ N0,1 and pathological risk features OSCC patients with T4a/ N2,3 Exclusion Criteria: Pregnant women paitents Taiwanese aboriginal patients Not primary OSCC patients OSCC patients with dysfunction of liver and/or kidneys

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Celecoxib<br>Combination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib | Drug: Celecoxib<br>* 200 mg of Celecoxib daily for 6-month treatment after surgery within 1 - 6 months<br>* Other names: Celebrex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free recurrence | 3-year follow-up after 6-month treatment of Celecoxib | 3 year relapse-free recurrence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival | 3-year follow-up after 6-month treatment of Celecoxib | 3 year relapse-free survival | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Celecoxib, Relapse-free OSCC patient, Recurrence, Survival, Prognosis
Physiologic MR Imaging of Salivary Gland Tumors

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to use advanced Magnetic Resonance Imaging (MRI) techniques to help identify the difference between cancerous and non-cancerous salivary gland tumors for improving treatment strategies and to aid in the prediction of disease progression.

Detailed Description
-----------------
The goal of this proposed study is to investigate the potential utility of combined analysis of parameters (Ktrans, ti and ADC) in discriminating benign from malignant salivary glands tumors (SGTs). A total of 30 treatment naïve patients suspicious of SGT as observed on clinical evaluation and prior routine CT, MRI, Ultrasound, FNAC and/or PET will undergo 3T MRI. The MRI protocol will include acquisition of anatomical images with and without contrast agent injection, diffusion imaging and dynamic contrast enhanced-MRI.

Official Title
-----------------
Physiologic MR Imaging in Distinguishing Benign From Malignant Salivary Gland Tumors

Conditions
-----------------
Salivary Gland Tumor

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Possess a salivary gland lesion of 1cm3 size Have no prior history of treatment for salivary gland lesion Exclusion Criteria: Has any prior history of cancer other than SGT Has any MRI contra-indications Has a history of known renal disease. Has history of prior radiation to head and neck region Is pregnant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Salivary Gland Tumor<br> | Diagnostic Test: MRI<br>* You are being asked to complete one research MRI scan with and without contrast since your most recent clinical evaluation and/or prior imaging has shown the presence of a suspicious salivary gland tumor, prior to your scheduled upcoming surgery. MRI contrast agents act like a dye to make MRI pictures brighter and easier to read. During each MRI scan, you will have an intravenous line (IV line) placed. The IV line allows the contrast agent to be injected into your vein. If you have a history of renal disease you may be asked to complete a blood draw of approximately 2.5cc (½ teaspoon), for glomerular filtration rate (GFR) assessment for participation into the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differentiation and Progression Free | Differentiation of malignant from benign neoplasms and progression free survival at 6 month starting from end of chemo-radiation treatment | 6 Month after the end of treatment |
Ganglion Cell Thickness in Enuresis Nocturna

Study Overview
=================
Brief Summary
-----------------
The precise role of the intrinsic circadian regulatory mechanism behind the pathogenesis of enuresis is not fully understood, but in theory, circadian rhythm irregularity may be the primary pathogenic mechanism not only for urinary outflow mechanisms but also for nocturnal bladder function. The proximity between SCN centers that control AVP release, sleep/arousal, voiding, and baroreregulation may provide the basis for circadian rhythm disturbance in one or more of these biological functions. Ganglion cells containing melanopsin pigment in the retina transmit the information they receive from the outside world about the light-dark state to the SCN via the retinohypothalamic pathway. Peripapillary retinal nerve fiber layer (RNFL) thickness, optic nerve head and macula are examined most frequently for the diagnosis of glaucoma and the detection of progression with optical coherence tomography (OCT). If differences in ganglion cell thickness can be detected using OCT in these children, a new avenue in Enuresis Nocturna may be opened.

Official Title
-----------------
Is Ganglion Cell Thickness the Main Problem in Enuresis Nocturna?

Conditions
-----------------
Enuresis, Nocturnal, Ganglion, Circadian Rhythm Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be between the ages of 5-18 have enuresis Exclusion Criteria: have any eye conditions

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- | --- |
| Difference in ganglion cell thickness in enuretic children | Normal values in RNFL measurements on OCT 75 (lowest)-107.2 (highest) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enuresis, optical coherence tomography
Real World Evidence Clinical Utility Study of KidneyIntelX

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.

Official Title
-----------------
Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Diseases, Diabetic Kidney Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging. Exclusion Criteria: Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population. Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria. Patients with ESRD or on renal recovery treatments at time of enrollment. Patients who are pregnant at the time of enrollment. Patients who are currently hospitalized. Patients without minimum 6 month pre-baseline KidneyIntelX medical history. Patients who are currently on Enbrel.

Ages Eligible for Study
-----------------
Minimum Age: 23 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: KidneyIntelX|KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referrals | Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist. | 6 Months | 
| Statins and or ACEi/ARB | Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers. | 6 Months | 
| HbA1c | Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c. | 6 Months | 
| SGLT2/ GLP1 | Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists. | 6 Months |
Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Study Overview
=================
Brief Summary
-----------------
The investigators have created and validated a device that allows us to accurately measure how many calories a baby consumes every day. The purpose of this study is to compare how many calories a baby consumes with how many calories are provided in a population of newborn infants and children. This may help clinicians to better understand how to feed babies during times of critical illness.

Official Title
-----------------
Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates

Conditions
-----------------
Calorie Overload, Calorie Deficiency

Intervention / Treatment
-----------------
* Device: Monitoring of energy expenditure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit Assent of patient's intensive care attending physician Written parental informed consent. Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen <80%. Exclusion Criteria: Clinically significant tracheo-esophageal fistula Measured ETT leak >20% (i.e. difference between inspiratory and expiratory tidal volumes) Patient on high frequency oscillatory ventilation or high frequency jet ventilation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonates<br>Neonates 0-28 days | Device: Monitoring of energy expenditure<br>* Continuous monitoring of energy expenditure.<br>|
| Infant<br>29 days to 1 year | Device: Monitoring of energy expenditure<br>* Continuous monitoring of energy expenditure.<br>|
| Child<br>>1 year and <10 kg | Device: Monitoring of energy expenditure<br>* Continuous monitoring of energy expenditure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average caloric expenditure | Number of calories consumed | through study completion, an average of 3 days |
SGLT2 Inhibitors and Hemoglobin

Study Overview
=================
Brief Summary
-----------------
Study of the response to SGLT2 inhibitors in type 2 diabetic patients with relevance to the erythropoesis and indexes of cardiorenal function. The study enrolls type 2 diabetic patients in whom the introduction of a SGLT2 inhibitor is deemed necessary as part of their routine treatment during their visit to our outpatient diabetes unit. A whole blood, a serum and a urine sample is obtained before and one month after the initiation of treatment with a SGLT2 inhibitor.

Official Title
-----------------
Study of the Mechanisms Leading to Increased Hemoglobin Levels and of the Cardiorenal Response in Type 2 Diabetic Patients With Recent Initiation of SGLT2 Inhibitors.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: SGLT2 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes Hba1C>7% on their current treatment introduction of SGLT2 inhibitor as part of their routine care Exclusion Criteria: eGFR<60 ml/min

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGLT2 inhibitor|Patients receive an SGLT2 inhibitor as part of theirn routine care.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin |  | 0-1 months | 
| Erythropoetin |  | 0-1 months | 
| NT-proBNP |  | 0-1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SGLT2 inhibitors, hemoglobin, NTproBNP, ketones
PET/MRI Imaging of Glutamate Release in the Brain

Study Overview
=================
Brief Summary
-----------------
Based on PET (18-PSS232) and MRI, glutamate release after N-acetylcystein challenge will be monitored in human brains.

Detailed Description
-----------------
Diagnostic trial with quantification of glutamate release in PET/MR.

Official Title
-----------------
PET/MRI Imaging of Glutamate Release in the Brain of Healthy Controls

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

Intervention / Treatment
-----------------
* Drug: 18F-PSS232


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteer Exclusion Criteria: smoker drug addiction significant neurological or psychiatric conditions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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 |
| --- | --- |
| Other: 18F-PSS232<br>Subjects receive baseline PET with 18F-PSS232 and stimulation PET with 18F-PSS232 after medical challenge with N-acetylcystein | Drug: 18F-PSS232<br>* Diagnostic PET Tracer<br>* Other names: 18FABP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of Binding Potentials of 18F-PSS232 in different brain regions between Baseline PET and PET after medical challenge | for details, please see Innis: Journal of Cerebral Blood Flow & Metabolism (2007) 27, 1533-1539 | Baseline PET and PET after medical challenge will be scanned within 3 months |