linjc16/ctgov huggingface dataset:
Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial

Study Overview
=================
Brief Summary
-----------------
Adult patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after orthotropic liver transplantation (OLTx) on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)

Official Title
-----------------
Comparison of Safety and Efficacy of Two Variants of Prolonged - Released Tacrolimus (Advagraf vs. Envarsus ) in Patients After Liver Transplantation : Single Center Randomised Control Trial

Conditions
-----------------
Liver Transplant Rejection, Immunosuppression

Intervention / Treatment
-----------------
* Drug: Envarsus
* Drug: Advagraf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults 18- 70 after liver transplantation due to liver cirrhosis primary liver transplantation Exclusion Criteria: liver transplantation due to liver cirrhosis and hepatocellular carcinoma (HCC) retransplantation renal impairment Parkinson disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advagraf<br> | Drug: Advagraf<br>* Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)<br>|
| Experimental: Envarsus<br> | Drug: Envarsus<br>* Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute rejection |  | 12 months | 
| chronic rejection |  | 5 years | 
| tremor |  | 12 months | 
| de novo diabetes |  | 5 years |
A Prospective Study of EUS Guided Celiac Block

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.

Official Title
-----------------
A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness

Conditions
-----------------
Chronic Pancreatitis, Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: triamcinolone
* Drug: 98% dehydrated alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing EUS-guided CB (for purposes other than this study) will be eligible to participate in this study. Patients with chronic pancreatitis and pancreatic cancer must have documented disease by CT, ERCP, or EUS. No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. Patient must provide signed written informed consent Exclusion Criteria: Patients that have had a previous celiac plexus block are eligible for this study

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 |
| --- | --- |
| 1<br>subjects who are getting a celiac block for chronic pancreatitis | Drug: triamcinolone<br>* 80mg of triamcinolone injected into the celiac ganglion during the EUS-CB<br>* Other names: Kenalog 80mg;|
| 2<br>subjects who are getting a celiac block for pancreatic cancer | Drug: 98% dehydrated alcohol<br>* 10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Coronary Artery Disease (CAD) in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
Aim of this study is the determination of a valid procedure for ischemia diagnositc in postmenopausal women.

Detailed Description
-----------------
In order to investigate which ischemia diagnostic presents which sensitivity and specificity for postmenopausal women, 100 consecutive patients presenting to our abmulance with stable angina pectoris and indication for myocardial szintigraphy will be enrolled in this study. An addidional stress-echocardiography and stress-MRI will be performed in this patients before they will reiceve their again routine coronay angiography. The different methods for ischemia diagnostic will be compared in order to determine the most valid method for this specific population.

Official Title
-----------------
Coronary Artery Disease in Postmenopausal Women. Comparison of Myocardial Szintigraphy With Sress-Echocardiography and Stress-MRI.

Conditions
-----------------
Postmenopausal Women, Stable Angina Pectoris

Intervention / Treatment
-----------------
* Procedure: stress-echocardiography
* Procedure: stress-MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women presenting to the hospital with stable Angina pectoris complaints and an indication for myocardial szintigraphy Exclusion Criteria: CABG Pacemaker or other metal implants Chronic bronchitis Asthma bronchiale Arterial Hypotension

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

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

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

| Intervention/Treatment |
| --- |
|Procedure: stress-echocardiography|stress-echocardiography will be performed once using Adenosin (140 µg/kg/min over 6 Minutes) and a contrast agent (SonoVue)|
|Procedure: stress-MRI|stress-MRI will be performed once using Adenosin (140 µg/kg/min over 6 Minutes)and a contrast agent (Gadovist)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparision of different ischemia diagnostic methods |  | before routine coronary angiography | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, ischemia diagnostic
Risk of Diabetes in Young Turner Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. The objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with Turner Syndrome compared to healthy controls.

Detailed Description
-----------------
The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam

Official Title
-----------------
Beta-Cell Function in Young Turner Syndrome Patients

Conditions
-----------------
Turner Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Turner Syndrome Females: Inclusion Criteria: Turner Syndrome confirmed by chromosomal testing On standard therapy (growth hormone and or estrogen) Exclusion Criteria: Type 1 or Type 2 diabetes Polycystic Ovarian Syndrome Pregnancy On any medications that alter blood sugar Healthy Female Controls: Inclusion Criteria: Healthy Exclusion Criteria: Type 1 or Type 2 diabetes Polycystic Ovarian Syndrome Pregnancy On any medications that alter blood sugar

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 22 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Turner Syndrome<br>Female with Turner Syndrome | |
| Healthy Controls<br>Healthy Female | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-Cell Function measured as Disposition Index | Disposition index will be calculated based on the results of the oral glucose tolerance test using minimal modeling (computer program) | 1 day at screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Turner Syndrome, Diabetes
Rapid Intravenous Infusion of Mannitol Results in a Dipper-type Change in Stroke Volume Variation in Patients Undergoing Major Neurosurgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the variation of Hemodynamics、lactic acid、base excess、peripheral vascular resistance and DO2 through FloTrac™/Vigileo™ system after rapid infusion mannitol in neurosurgery.The hemodynamic changes after mannitol infusion are shown in Figure 1. HR (Fig. 1A) and systolic BP (Figure 1B) significantly increased between 0 min and 10 min (P = 0.041) and between -10 min and 10 min (P = 0.073), respectively; these two variables decreased steadily and returned to the baseline. Diastolic BP (Fig. 1B) showed no significant change after mannitol infusion (P = 0.102). CVP (Fig. 1C) significantly increased between -20 min and 0 min (P < 0.001) and constantly decreased after 0 min, which remained below the baseline between 30 min and 60 min. CI (Fig. 1D) and SVI (Fig. 1E) showed a significant persistent increase between -20 min to 0 min (P < 0.001) and between -20 min and 10 min (P < 0.001), respectively. SVV exhibited a dipper-type change shown as a significant decrease between -20 min and 0 min and a significant increase between 0 min and 60 min (P < 0.001), which returned to the baseline after 20 min.

Conditions
-----------------
Craniotomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were: being aged between 16 and 70 years; with a body mass index of 18-25 kg/m2; with a physical status classified as ASA class I or II; and scheduled for elective craniotomy Exclusion Criteria: Any patient would be excluded from this study if the patient had complicating serious coagulopathy, hepatorenal insufficiency, aortic regurgitation, or cardiac arrhythmia; had a previous history of intra-aortic balloon counterpulsation; exhibited systolic blood pressure (SBP) ≥160 mmHg, diastolic blood pressure (DBP) ≥100 mmHg, or heart rate ≥ 100 bpm on operating room admission; or rejected to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index |  | during the procedure | 
| stroke volume index |  | during the procedure | 
| stroke volume variation |  | during the procedure | 
| systolic pressure |  | during the procedure | 
| central venous pressure |  | during the procedure | 
| heart rate |  | during the procedure | 
| peripheral vascular resistance |  | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| base excess |  | during the procedure | 
| lactic acid |  | during the procedure | 
| DO2I |  | during the procedure |
Echocardiographic Assessment of the Impact of Diabetes and Prognostic Analysis of Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluat the impact of diabetes on cardiac function in patients with heart transplantation by multimodal imaging and analyse their prognosis.

Detailed Description
-----------------
This study is planed to enroll 300000 patients after heart transplantation, all the patients will be divided into 3 groups according to whether or not they have diabetes and when did they develop diabete. Echocardiography will be used to evaluat their cardiac function. Comparing their cardiac function and clinical information and analysing their prognosis to evaluat the impact of diabetes.

Official Title
-----------------
A Multicenter Clinical Study of Echocardiographic Evaluation of the Impact of Diabetes and Prognostic Analysis of Heart Transplantation

Conditions
-----------------
Heart Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who received a heart transplant after 2015 Exclusion Criteria: The image quality is poor

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 |
| --- | --- |
| non-diabetes group<br>patients who underwent heart tranplantation without diabetes | |
| pre-transplant diabetes group<br>patients who underwent heart tranplantation with diabetes before the transplantation | |
| post transplant daibetes group<br>patients who underwent heart tranplantation without diabetes until after the transplantation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | death from all causes | up to 2023.12 | 
| acute rejection | acute rejection required treatment | up to 2023.12 | 
| readmission | readmission from all causes | up to 2023.12 |
Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Study Overview
=================
Brief Summary
-----------------
Interventional and comparative prospective study: Sixty-nine eyes (38 patients) suffering from keratoconus (stages 1-2 Amsler-Krumeich classification) will be divided into four groups. The four groups underwent topography- and non-topography-guided PRK with sequential and simultaneous CXL. The main outcome measures will be pre-and postoperative uncorrected distance visual acuity (UDVA), best-corrected distance visual acuity (CDVA), manifest refraction, contrast sensitivity, and keratometry

Official Title
-----------------
Advanced Surface Ablation With Corneal Cross Linking in Mild Keratoconus

Conditions
-----------------
Keratoconus, Corneal Cross-Linking

Intervention / Treatment
-----------------
* Procedure: Photorefractive Keratectomy with Corneal Cross-Linking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for the study focused on patients over 34 (range from 34 to 41) with stable corneal topography and refraction for at least six months and an estimated residual bed thickness of >410 µm. exclusion from the study included the presence of macular or retinal disease, dry eye, history of recurrent corneal erosions, anterior segment abnormalities, unstable refractive error, post-surgically residual stromal bed thickness of under 350 mm, autoimmune disease, collagen vascular disease, immunosuppressive therapy, or current use of systemic corticosteroids, diabetes mellitus, pregnancy, and lactation.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photorefractive Keratectomy with Corneal Cross-Linking<br>For correction of refractive error | Procedure: Photorefractive Keratectomy with Corneal Cross-Linking<br>* To our knowledge, this study is one of the first to compare the visual results of non-topography-guided and topography-guided photorefractive keratectomy (PRK) applying sequential and simultaneous corneal cross-linking (CXL) treatment for keratoconus. Considering recent advances in cross-linking and imaging in keratoconus, the outcomes of this study can lead us to several non-invasive algorithm management options.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Evaluation of the uncorrected visual acuity, best corrected visual acuity, astigmatism, intraocular pressure and endothelial cell loss before and after the last operation. | 3 year |
Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance

Study Overview
=================
Brief Summary
-----------------
Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure) caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep and/or post-sleep performance are affected is not known. The study hypothesis is that sleep and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at altitudes of 8,000 or less.

Official Title
-----------------
Investigation to Determine the Effects of Mild Hypobaric Hypoxia on Sleep and Post-Sleep Neurobehavioral Performance

Conditions
-----------------
Altitude, Hypoxia, Environmental Sleep Disorder

Intervention / Treatment
-----------------
* Procedure: altitude exposure in hypobaric chamber


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy age 30 to 60 years Exclusion Criteria: sleep disorders or abnormal sleep patterns mood or psychiatric disorders including claustrophobia altitude exposure above 5,000 ft in the previous 2 months born or raised at terrestrial altitude 5,000 ft or greater conditions that would disqualify for FAA Medical Certificate acute medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: altitude exposure in hypobaric chamber|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality and quantity of sleep measured by actigraphy and polysomnography Neurobehavioral performance measured by Psychomotor Vigilance Test (PVT) and Automated Neurophysiologic Assessment Metrics Battery (ANAM) |  | 7 hours; 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood State measured by Profile of Mood States (POMS) Symptoms of altitude illness measured by Environmental Symptoms Questionnaire (ESQ IV) and Lake Louise Symptom Scores (LLS) |  | 20 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high altitude, sleep, altitude illness, neurobehavioral manifestations, psychomotor performance, mood states
Microlearning Application for Diabetes Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of a mobile application diabetes prevention program delivered with microlearning and microcoaching.

Detailed Description
-----------------
Patients with prediabetes who are interested in joining a diabetes prevention program will be randomized to either the mobile application diabetes prevention program or the traditional diabetes prevention program, which is delivered as a mixed program of in-person and virtual sessions. Study participants in the mobile application version will download the Health U app from the Apple application store. The user will complete the daily microlearning modules and the health coach interactions within the Health U application. The 12-month diabetes prevention program will follow the widely clinically-validated CDC Get Active to Prevent T2 curriculum. For participants participating in the in-person version, they will complete the diabetes prevention program, which meets in-person and virtually approximately once every two weeks.

Official Title
-----------------
Validation of a Microlearning Approach to a Diabetes Prevention Program

Conditions
-----------------
PreDiabetes, Elevated Blood Sugar

Intervention / Treatment
-----------------
* Other: Health U mobile application
* Other: National Diabetes Prevention Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 85 years old high risk for type 2 diabetes (history of gestational diabetes, A1c 5.7-6.4) Exclusion Criteria: pregnant non-English speaker not comfortable using a mobile application

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application program<br> | Other: Health U mobile application<br>* Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application<br>|
| Active Comparator: Traditional program<br> | Other: National Diabetes Prevention Program<br>* CDC recognized National DPP that follows a set curriculum with modules delivered over 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight lost at 12 months from baseline weight |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hemoglobin A1c |  | 12 months |