linjc16/ctgov huggingface dataset:
Plaque Stability and Metabolomics in Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
At present, the investigators don't know the relationship between plaque stability and the metabonomics changes. In the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. Statistic analysis were carried out to analyze the correlation between plaque stability and metabonomics changes among these study patients.

Official Title
-----------------
The Relationship Between Plaque Stability Evaluated by IVUS and Metabolomics in Stable Coronary Heart Disease Patients

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: This is an observational study, we don't have any interventions.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by IVUS will be recruited. Exclusion Criteria: renal insufficiency with serum creatinine > 20 mg/L; regnant/lactating women, or the women receive hormone replacement therapy in premenopausal or postmenopausal; patients have a history of abusing alcohol or other drugs in the past two years, active hepatitis, cirrhosis; endocrine abnormalities without therapy (diabetic ketoacidosis, thyroid disease, etc.); The body's inflammatory disease, rheumatoid arthritis, osteoarthritis, ulcerative bowel disease, systemic lupus erythematosus (sle), etc.), myositis/myopathy, cancer; Dilated cardiomyopathy, valvular heart disease, persistent atrial fibrillation; patients recently injured;（8）Other researchers don't agree to join this study.

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: This is an observational study, we don't have any interventions.|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque stability | The investigators will use the intravascular ultrasound to assess the coronary plaque stability of the patients with coronary heart disease. | 07/01/2021-07/31/2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabonomics | Serum or plasma will be collected by the investigators and high-throughput sequencing will be used to assess the metabonomics of patients with coronary heart disease. | 07/01/2021-07/31/2024 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plaque stability, metabonomics
Magnetic Resonance Elastography of Cardiac Transplant Rejection

Study Overview
=================
Brief Summary
-----------------
Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Detailed Description
-----------------
Patient will undergo MRE beginning 4-8 weeks post transplant, then with each scheduled cardiac biopsy through 7-8 months post transplant. Results of the MRE will be compared against results of the cardiac biopsy to determine if the non-invasive MRE can predict cardiac transplant rejection.

Official Title
-----------------
Magnetic Resonance Elastography of Cardiac Transplant Rejection

Conditions
-----------------
Acute Graft Rejection

Intervention / Treatment
-----------------
* Device: Magnetic Resonance Elastography driver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have undergone cardiac transplantation at the Ohio State University Ross Heart Hospital. Patients must be able to lie flat on their back in the scanner for up to 60 minutes Patient must be able to hold their breath for up to 15 seconds at a time. Exclusion Criteria: Patients who are claustrophobic Patients who are pregnant, due to potential risks to the fetus. Patients with any unapproved, non-MRI safe metal/devices in their bodies.

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 |
| --- | --- |
| Experimental: Arm 1<br>Patients who have received a cardiac transplant at The Ohio State University Ross Heart Hospital will undergo Magnetic Resonance Elastography (MRE) (using a Magnetic Resonance Elastography driver) within 24-48 hours of standard of care biopsy. Results of both will be compared to determine if MRE can successfully predict cardiac transplant rejection. | Device: Magnetic Resonance Elastography driver<br>* A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ.<br>* Other names: Siemens MRE Driver;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Stiffness With Magnetic Resonance Elastography (MRE) | MRE scans will be performed within 24-48 hours of standard of care cardiac biopsies for patients who have undergone cardiac transplant at The Ohio State University Ross Heart Hospital. Stiffness results from the MRE will be compared to histopathology from the cardiac biopsy to determine if the completely non-invasive MRE can successfully predict transplant rejection. | 24-48 hours |
Prevalence of Wildtype Amyloid After TAVR

Study Overview
=================
Brief Summary
-----------------
Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary amyloidosis is a different type of disease which requires different treatment.

Detailed Description
-----------------
This research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but it is a condition that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.

Official Title
-----------------
Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics

Conditions
-----------------
Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients that underwent a TAVR procedure at the Malcolm Randall VA Medical Center. Implant of current generation TAVR (i.e. Sapien S3, Evolut R, or Evolut Pro). Willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after valve deployment. Willingness to have blood drawn Willingness to complete SF12 quality of life KCCQ Exclusion Criteria: --Patient that do not qualify for a TAVR procedure as normal clinical care

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Measurement tool is the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 1 to 2 years post TAVR |
Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
A growing body of work done over the past few decades has established that adipose tissue as an active endocrine organ which secretes a wide range of metabolic and immunological factors collectively called adipokines (1). Importantly, these secreted factors enter into the circulation and have paracrine and autocrine actions, which profoundly impact systemic metabolism (e.g., insulin sensitivity). Additionally, in animals, loss of ovarian hormone production via ovariectomy (similar to menopause in humans) leads to increases in both in adipose tissue mass and in adipose tissue inflammation (2) making this tissue less healthy than that from premenopausal animals. To date, no studies have investigated the effect of menopause on abdominal fat in overweight individuals. Knowing if adipose tissue-specific changes occur with menopause may potentially lead to recommendations or therapeutics to improve women's health post menopause.

Detailed Description
-----------------
Subjects will just have to agree to having a small amount of adipose tissue being removed during the bariatric surgery. The investigators will also collect a blood sample at that time. There will be no other visits for the subject.

Official Title
-----------------
Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery

Conditions
-----------------
Obesity, Morbid, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Procedure: bariatric surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are premenopausal or who are postmenopausal and have been for at least one year. Males will be recruited to age match female subjects. All subject are already scheduled to have bariatric surgery at the University of Missouri-Columbia Department of Surgery. Exclusion Criteria: Women who are perimenopausal. Women who are on Hormone Replacement Therapy.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: bariatric surgery|We are recruiting only those going through bariatric surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNFa | TNFa | measured in the one sample collected at surgery | 
| Il-6 | Il-6 | measured in the one sample collected at surgery | 
| macrophage | macrophage | measured in the one sample collected at surgery |
A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

Detailed Description
-----------------
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ,aged 30-80 years Clinical diagnosis of early stage idiopathic Parkinson's disease Experiencing two of the three following signs; bradykinesia, rigidity, and tremor Not currently taking any antiparkinson medication Exclusion Criteria: A history of alcohol or drug abuse in the past year A diagnosis psychiatric illness Patients who currently are taking MAO inhibitors within 30 days of entering the study Patients who are hypersensitive to selegiline, MAO-B inhibitors, or tricyclic antidepressants Additional inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the need for symptomatic treatment with dopaminergic agents, defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator |  |  | 
| Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual change rates for Unified Parkinsons Disease Rating Scalescore |  |  | 
| Changes in UPDRS score after 4 weeks and after withdrawal of study treatment |  |  | 
| Percentage of patients needing symptomatic treatment within 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early stage idiopathic Parkinson's disease
Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the ability of clinical scores (P-SAP, OSA50, DES-OSA, STOP-Bang with former algorithm, and STOP-Bang with new algorithm).

Detailed Description
-----------------
Severe OSA (Obstructive Sleep Apnea) patients are at higher risk of postoperative complications. STOP-Bang has been proposed to detect OSA patients. It has been validated. New algorithm of STOP-Bang was proposed by the end of 2016. This aim of this study was to evaluate the ability of this new algorithm to detect severe OSA patients (patients with more than 30 events per hour). The new algorithm was also compared in this same ability with three others clinical score (P-SAP, OSA50 and DES-OSA).

Official Title
-----------------
Comparison of the New Algorithm of STOP-Bang in the Detection of Severe OSA Patients

Conditions
-----------------
Apnea, Sleep

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in the preoperative anesthesia visit between 01/08/2016 and 31/12/2017 Exclusion Criteria: Patient's refusal

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>All patients included in the study. First: clinical scores were collected in all patients. Second: all patients underwent a polysomnography in order to compare this results with these of the clinical scores. | Diagnostic Test: Polysomnography<br>* To compare the ability of the clinical scores, all patients included in this study underwent a polysomnography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of results of clinical scores and results of polysomnography. | Comparison of the two results to determine the sensitivity and specificity of each clinical scores in comparison with polysmnography (the gold standard). | 1 night |
Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX

Study Overview
=================
Brief Summary
-----------------
This registration is for clinical use of the FENIX, a Humanitarian Use Device (HUD) for fecal incontinence. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).

Detailed Description
-----------------
The FENIX is surgically placed. This surgery could be an outpatient procedure or at most an overnight stay in the hospital. The design of the device allows it to be effective immediately. The device is similar to the LINX device used for esophageal reflux. It is a circular set of magnets which surrounds the ano-rectal support. The size of the device is determined at the time of surgery so that the ano-rectum is closed. When the patient strains at stool, this pressure separates the magnets and allows passage of stool. The magnets are held together by an independent malleable titanium wire. Once straining at stool stops, the magnets are able to re-connect or close the rectum. We will monitor patients for postoperative complications related to surgery.

Official Title
-----------------
Clinical Use of a Magnetic Anal Sphincter Augmentation Device, Trade Name FENIX. A Humanitarian Use Device ( HUD), Which Has Recently Received a Humanitarian Device Exemption (HDE) From the Food and Drug Administration ( FDA)

Conditions
-----------------
Fecal Incontinence

Intervention / Treatment
-----------------
* Device: magnetic anal sphincter augmentation for fecal incontinence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-pregnant female patients 18 years of age or older with fecal incontinence failed conservative therapy ( pelvic floor physical therapy, medications) and failed trial of interstim. Exclusion Criteria: patients less than 18 years of age, pregnant previous radiation to pelvis, chronic diarrhea or inflammatory bowel disease.

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

| Intervention/Treatment |
| --- |
|Device: magnetic anal sphincter augmentation for fecal incontinence|Surgical placement of HUD called FENIX for female patients that have failed conservative therapy and less invasive therapies or who are not candidates for such therapies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Relationship Between Triceps Skinfold and Overall Survival of Pancreas, Bile Duct, Gallbladder Cancer

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.

Detailed Description
-----------------
Cachexia is frequently seen in pancreatic cancer(70-80%) and associated with reduced survival, reduced treatment tolerance and reduction in QoL. In recent studies, low-normal BMI have worse outcome (overall mortality) in cardiovascular, malignant, chronic disease (So called obesity paradox) BMI is simple method but hard to define body composition because BMI is based on only weight and height. Skinfold thickness is strongly associated with body fatness than BMI. In this study, the ivestigators aim to demonstration of relationship between triceps skinfold thickness and overall survival of pancreatic cancer, cholangiocarcinoma and GB cancer.

Official Title
-----------------
The Relationship Between Triceps Skinfold and Overall Survival of Pancreatic Cancer, Cholangiocarcinoma and Gallbladder Cancer.

Conditions
-----------------
Pancreas Cancer, Cholangiocarcinoma, Gallbladder Cancer

Intervention / Treatment
-----------------
* Other: Measurement of triceps skinfold thickness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed pancreatic, bile duct or gallbladder cancer patients, undergoing therapeutic management (including surgery, chemotherapy or palliative care). Age above 18 years old Exclusion Criteria: Other malignant disease Underlying intestinal disease that cause absorprtion disorder Underlying psychiatric disorder such as eating disorder (bulimia, anorexia)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer patients<br>Newly diagnosed pancreatic, bile duct or GB cancer patients at samsung medical center. | Other: Measurement of triceps skinfold thickness<br>* By using skin thickness caliper, measure triceps skinfold thickness on the half of forearm (Rt side). In every 3 weeks, triceps skinfold thickness will be measured.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The duration between diagnosis and death | through study completion, an average of 2 year |