linjc16/ctgov huggingface dataset:
Oxandrolone Multiligament Knee

Study Overview
=================
Brief Summary
-----------------
This study is about healing after a rmultiligament knee reconstruction procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks is effective in aiding in the healing process and restoring muscle mass.

Official Title
-----------------
Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial

Conditions
-----------------
Ligament Tear Knee

Intervention / Treatment
-----------------
* Drug: Oxandrolone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction Exclusion Criteria: Patients with prior ipsilateral knee surgery Untreated diabetes mellitus Pituitary tumor Rheumatoid Arthritis Uncontrolled hypertension Congestive Heart Failure Myocardial Infarction within the past 6 months End-stage renal disease Liver enzymes two times the normal value DVT within the past 6 months Disorder of the coagulation system Currently taking anticoagulation Prior or current use of anabolic steroids Chromosomal disorders Prostate cancer Breast cancer Hypercalcemia Patients with COPD not responsive to bronchodilators Patients with known liver disease Patients at risk for liver tumors Severe hyperlipidemia Patients taking medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors, acetaminophen (Tylenol, others), cholesterol lowering

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Oxandrolone | Drug: Oxandrolone<br>* oral oxandrolone for 12 weeks<br>|
| Placebo Comparator: Placebo Group<br>Placebo | Drug: Placebo<br>* oral placebo for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lean body mass | measured by bioelectrical impedance analysis | Change from baseline at 52 weeks | 
| body fat percentage | measured by bioelectrical impedance analysis | Change from baseline at 52 weeksf | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxandrolone, Testosterone, Anabolic Steroid
Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to obtain information on cerebral glucose metabolism measured with the 18F-FDG PET technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects ( patients with disease neurological or psychiatric) which will be evaluated with the same method to improve the specificity and diagnostic sensitivity of the FDG PET exam. The objective is to obtain a functional measure of brain glucose metabolism in every normal subject because this is a functional measure of brain activity. The subjects will represent different decades of age to have a wider range of comparison with patients.

Official Title
-----------------
Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.

Conditions
-----------------
Neuro-Degenerative Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: absence of neurological and psychiatric pathologies, negative pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Diagnostic accuracy|The aim is to obtain a regional measure of brain glucose metabolism in each normal subject because this is a functional measure of brain activity.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of glucose metabolism with 18 F FDG PET | Study of glucose metabolism with 18 F FDG PET in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for statistical analyzes for comparison with individual subjects (patients with neurological or psychiatric) which will be evaluated with the same method to improve the diagnostic sensitivity of the FDG PET exam. | 1 year |
Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to learn about heart function and high lung blood pressure in patients with heart failure. The main question[s] it aims to answer are whether we can improve the ability to predict patients who will have complications after they receive treatment including heart transplant and left ventricular assist devices.

Detailed Description
-----------------
Prospective cohort study of patients with heart failure with reduced ejection fraction that are referred for diagnostic right heart catheterization as part of their evaluation for candidacy for advanced heart failure therapies.

Official Title
-----------------
Hemodynamic Testing Strategies to Assess Pulmonary Hypertension and Right Ventricular Function in Heart Failure Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Diagnostic Test: Right Heart Catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 years or older Heart failure with reduced ejection fraction (<40%) referred for RHC at our centre for evaluation of candidacy for advanced HF therapies. Exclusion Criteria: Severe valvular or complex congenital heart disease Short-term mechanical circulatory support for progressive cardiogenic shock (e.g. extracorporeal membrane oxygenation) Acute coronary syndrome or revascularization occurred within 7 days prior to the RHC. Pregnant or breast-feeding Known hypersensitivity to sodium nitroprusside Advanced liver dysfunction Reduced capacity or inability to provide informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Right Heart Catheterization|Procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pulmonary artery pressure | Hemodynamic measurement | First study 1 day visit | 
| right ventricular end systolic elastance | Hemodynamic measurement | First study 1 day visit | 
| pulmonary arterial elastance | hemodynamic measurement | First study 1 day visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular failure after heart transplant | Clinical outcome | 1 year | 
| Right ventricular failure after left ventricular assist device | Clinical outcome | 1 year |
Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis

Study Overview
=================
Brief Summary
-----------------
Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.

Detailed Description
-----------------
The current guidelines for suspected choledocholithiasis are aimed to reduce the risk of patient receiving diagnostic ERCP and reduce the risk of post ERCP adverse events. In this process there is apparent increase in number of patients in the intermediate likelihood group requiring EUS or MRCP. This can increase the health care utilization and cost of care for intermediate likelihood patients. The field of artificial intelligence in clinical medicine is evolving rapidly. The use of artificial intelligence based machine learning model is not adequately studied for prediction of choledocholithiasis. Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.

Official Title
-----------------
Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis- A Prospective, Open Label, Diagnostic Study

Conditions
-----------------
Choledocholithiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Individual 18 years or older with a suspected choledocholithiasis satisfying either ASGE or ESGE risk stratification criteria of intermediate likelihood undergoing EUS or MRCP Exclusion Criteria: Patients having co-exiting disease of pancreato biliary system other than gall stones and choledocholithiasis which include chronic pancreatitis, biliary stricture, pancreatobiliary malignancy, portal biliopathy Patients having underlying chronic liver diseases Pregnancy and breast feeding Previous history of cholecystectomy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of machine learning algorithm to predict choledocholithiasis | develop machine learning algorithm to predict choledocholithiasis in patients with intermediate likelihood of choledocholithiasis | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Compare diagnostic accuracy of EUS or MRCP with machine learning algorithm | 1. Compare diagnostic accuracy of EUS or MRCP with machine learning algorithm | One year | 
| 2. To validate machine learning algorithm |  | One Year |
COVID Infection in Pediatric Surgical Patient

Study Overview
=================
Brief Summary
-----------------
Children infected with COVID-19 are mostly asymptomatic. There is a dearth of data on the epidemiology of COVID-19 in the pediatric population. This is a prospective observational clinical study of pediatric surgical patients. COVID-19 rapid antigen testing will be performed on pediatric patients.

Detailed Description
-----------------
Children infected with COVID-19 are mostly asymptomatic or mildly symptomatic. Children may spread COVID-19 to the elderly, vulnerable patients and medical staff. There is a dearth of data on the epidemiology of COVID-19 in the pediatric surgical population. Rapid antigen detection tests for the diagnosis of COVID-19 are reliable, simple, fast, and inexpensive. This is a prospective observational clinical study. The study population will include all consenting pediatric surgical patients, aged 2-17 years. Informed consent will be obtained from each patient and the legal guardian who agree to participate in the study. Nasopharyngeal swab specimens will be collected from anesthetized pediatric patients. COVID-19 rapid antigen testing will be performed according to the equipment manufacturer's instructions. Data collection will include COVID-19 test result, nasal swab complication, patient demographics, surgical history, medical history, regular medications, COVID-19 symptoms, and COVID-19 exposure information. COVID-19 symptoms that will be recorded are cough, wheeze, nasal congestion, breathing difficulty, new loss of taste or smell, fever, chills, rigors, body aches, sore throat, nausea, and fatigue. COVID-19 exposure will be considered as being within 6 feet of a person with diagnosed COVID-19 infection in the previous 14 days.

Official Title
-----------------
Prevalence of Asymptomatic COVID-19 Infection in Pediatric Surgical Patients

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: Rapid antigen test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical patients aged 2-17 years informed consent no COVID-19 diagnosis in previous 6 months no history of nasal bleeding no history of coagulopathy. Exclusion Criteria: patient refusal of testing difficulty in obtaining consent COVID-19 diagnosis in recent 6 month history of nasal bleeding history of coagulopathy.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Rapid antigen test|COVID-19 rapid antigen testing of nasal swab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antigen test positive result | COVID-19 antigen test positive | 1 day |
Swept Source OCT Imaging With the DREAM VG-OCT

Study Overview
=================
Brief Summary
-----------------
The Intalight Dream OCT is the first combo anterior plus posterior device to perform both OCT and OCT-A at depth of 16mm. This is especially useful in patient who are very nearsighted as it allows us to image all in one frame. The intention of this study is to see how the images differ on the same patients when compared to the Cirrus OCT and to test for the repeatability of the images on a single day.

Official Title
-----------------
Swept Source OCT Imaging With the DREAM VG-OCT

Conditions
-----------------
Eye Diseases, Myopia, Glaucoma

Intervention / Treatment
-----------------
* Device: DREAM OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 Myopes with a current or previously documented spherical equivalent refraction < -4D At least half of the subjects should have had at least one Cirrus OCT RNFL and macula performed as well as a Humphrey visual field performed in those with OCT abnormalities Exclusion Criteria: Unable to comply with study imaging unclear ocular media Participant has, in the opinion of the investigator, any physical or mental condition that would affect the participation in the study or may interfere with the study procedures, evaluations and outcome assessments.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DREAM OCT<br>All 50 patients will have both eyes (if able) imaged, 3 times, on the same day during their clinic visit. | Device: DREAM OCT<br>* Swept Source OCT (similar to Zeiss Plex Elite)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing difference in intraocular structures | Assessing the performance of the DREAM VG OCT scan patterns in high myopes including glaucomatous eyes to see if there are differences in the lamina cribrosa structure when compared to patients previous Cirrus OCTs. | Baseline | 
| Assessing difference in intraocular vascular structures | Assessing differences in vascular density in areas with presumed myopic-related field defects vs. low tension glaucoma perimetric disease | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing repeatability of scans | Analyze the repeatability of quantitative RNFL and GCC parameters. | Baseline |
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.

Detailed Description
-----------------
Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are: group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour. N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.) control group of patients. Number of patients according to sample size equation. Sample size equation is used to calculate the minimum size of the required sample: n = (z)2 p (1- p) / d2 Number of patients according to sample size equation about 300 patients 150 patient in each group of study. Estimated study duration 2 years. N.B. Randomization method: first patient prepared to PCI will be included in colchicine group second patient will be included in control group and so on.

Official Title
-----------------
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention

Conditions
-----------------
Periprocedural Myocardial Infarction, Periprocedural Myocardial Injury

Intervention / Treatment
-----------------
* Drug: Colchicine Pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients . PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized). PPMI (rise in post-PCI troponin plus new evidence of ischemia). Exclusion Criteria: Patients with active infections. Patients taking anti-inflammatory medications. Patients presented with ACS( still rising troponin). Severe renal impairment ( creatinine clearance < 45 ml/min ). Primary PCI, rescue PCI, pharmacoinvasive therapy. Connective tissue diseases.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| colchicine group<br> | Drug: Colchicine Pill<br>* oral pills<br>|
| control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACEs | Major Adverse Cardiac Events | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colchicine - PCI - PPMI
Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

Study Overview
=================
Brief Summary
-----------------
This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.

Official Title
-----------------
A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

Conditions
-----------------
Temporal Hollowing

Intervention / Treatment
-----------------
* Device: Restylane Contour


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or non-pregnant, non-breastfeeding females, 22 years of age or older Intent to undergo treatment for correction of temple hollowing Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject) Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments Any previous aesthetic procedures or implants Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Restylane Contour<br>* a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate based on the Blinded Evaluators' live assessment of the GTVDS |  | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates, as assessed by the Blinded Evaluator at 6, 9 and 12 months after baseline for the treatment group |  | 6,9,12 months after baseline |