linjc16/ctgov huggingface dataset:
Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
Background: 18B Glycyrrhetinic acid (active compound of Licorice) decreases serum potassium via enhanced renal potassium loss in healthy individuals and thereby inducing renal sodium retention and arterial hypertension.In dialysis patients this mechanism is disturbed and compensatory intestinal potassium secretion is enhanced. 18B Glycyrrhetinic acid is an inhibitor of 11B Hydroxysteroid dehydrogenase type 1 (11b HSD1). Inhibition of 11 b HSD1 offers a novel potential therapy to lower intracellular cortisol concentrations and thereby enhance insulin sensitivity. Hypothesis: Glycyrrhetinic acid decreases serum potassium by enhanced intestinal excretion in dialysis patients and increases insulin sensivity by inhibition of 11b HSD Methods: double blind, 6 month cross over trial comparing oral 18b Glycyrrhetinic acid with placebo in 24 nondiabetic dialysis patients. Endpoints: predialytic serum potassium levels, insuline sensitivity assessed by fasting glucose and fasting insulin concentrations

Official Title
-----------------
Glycyrrhetinic Acid-Effect on Serum Potassium and Insulin Resistance in Dialysis Patients

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Drug: oral 18B Glycyrrhetinic acid versus placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dialysis patients (>3 months) Exclusion Criteria: diabetics hospital stay in the last 4 weeks
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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oral 18B Glycyrrhetinic acid versus placebo|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
-----------------
Dialysis, Serum potassium, 18b glycyrrhetinic acid, insulin sensitivity
Fluorescent-labeled IgG for Liver Tumor Detection

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate whether intraoperative fluorescence imaging using fluorescent-labeled IgG probe (FluoAB) can help distinguish the tumor and the liver cirrhosis (or the liver parenchyma). The main purposes of this study include: To validate the safety and effectiveness of using FluoAB in hepatic surgery. To raise the surgical precision with guidance by FluoAB fluorescence imaging.

Official Title
-----------------
Intraoperative Liver Tumor Imaging Using Fluorescent-labeled Human IgG

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Drug: FluoAB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been diagnosed with liver tumor. Planned to receive hepatectomy. Liver function Child-Pugh A/B. The expected lifetime is longer than 6 months. Approved to sign the informed consent. Exclusion Criteria: Enrolled in other trials in the past 3 months. Metastatic lesions were found. Undesirable function of heart, lung, kidney, or any other organs. Unable to tolerate a hepatectomy. The researchers considered inappropriate to be included.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FluoAB intraoperative fluorescence imaging<br>The patients will receive an injection of FluoAB. Surgery will be performed with guidance by FluoAB fluorescence imaging. | Drug: FluoAB<br>* Drug Injection: FluoAB (fluorescent-labeled IgG)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor imaging precision | Sensitivity and specificity of hepatic malignancy detection by fluoAB intraoperative imaging. | Update with an average of 2 weeks. | 
| Tumor lesions | Numbers of intraoperatively detected tumor lesions. | Immediately after the hepatic surgery. |
Post-Market Study of the St. Jude Medical Angio-Seal™ V-Twist Integrated Platform (VIP) Vascular Closure Device

Study Overview
=================
Brief Summary
-----------------
To characterize the clinical outcomes of Angio-Seal VIP with St. Jude Medical (SJM) collagen through the collection of device/procedure-related major vascular complications and time to hemostasis.

Conditions
-----------------
Vascular Closure

Intervention / Treatment
-----------------
* Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires closure of femoral artery puncture resulting from arterial access procedure. Patient is ≥18 years of age. Patient is willing to provide written informed consent prior to study device use. Patient is willing and able to adhere to data collection and follow-up requirements. Exclusion Criteria: Patient is participating in another clinical trial which has the potential to impact hemostasis. Patient has an active groin infection or systemic infection. Patient has undergone a vascular access procedure within the past 90 days. Patient has been previously enrolled in the study. (For patients undergoing multiple interventions within a timeframe of 90 days, only the initial procedure may constitute a study enrollment.)

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 |
| --- | --- |
| Angio-Seal VIP Vascular Closure<br> | Device: Angio-Seal VIP 6 French (6F) and 8 French (8F) devices<br>* These devices are used for the vascular closure procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication | Major vascular complications include: Access Site Complications: Hematoma >10 cm in size requiring surgical or percutaneous intervention Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics A/V Fistula requiring medical intervention (percutaneous or surgical) Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical) | 30 days post procedure | 
| The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment. |  | within 5 minutes of device deployment |
Internal Jugular Vein Cross Sectional Area

Study Overview
=================
Brief Summary
-----------------
The Trendelenburg position is used to distend the central veins, improving both success and safety of vascular cannulation. The purpose of this study is to measure the cross-sectional area of the internal jugular vein (IJV) in three different positions, using surface ultrasound.

Official Title
-----------------
Effect of Position on Cross Sectional Area of IJV

Conditions
-----------------
Central Venous Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult medical or surgical ICU patients who have preexisting central venous (jugular/subclavian only) catheters. Exclusion Criteria: subjects with only a femoral venous catheter. subjects whose CVP measurement by the indwelling catheter exceeds 20cm of water. subjects younger than 18 years old. inability to obtain informed consent from the subject or the subjects authorized representative.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- | --- |
| Effect of trendelenburg and reverse trendelenburg position on the cross sectional area of the internal jugular vein | There will be substantial anatomic variation in venous size. Further, Trendelenburg positioning will have little impact on venous cross-sectional area in most subjects when compared with supine. | At time of data collection: physiologic study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CVP, US, Trendelenburg position, Ultrasound, Head Down Tilt
Relationship Between Electrical Pain Tolerance Threshold of Alveolar Ridge and Individual Attributes

Study Overview
=================
Brief Summary
-----------------
This study was conducted with an aim to know how individual attributes associated to intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and psychological state evaluated by the Profile of Mood States.

Conditions
-----------------
Intraoral Pain Threshold

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: not pacemaker wearers Exclusion Criteria: general health problems that could affect the measurement of nerve activity a lack of understanding of written or spoken Japanese

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain threshold | intraoral electrical pain threshold | 20minutes |
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.

Detailed Description
-----------------
To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis.

Official Title
-----------------
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

Conditions
-----------------
Eye Diseases

Intervention / Treatment
-----------------
* Drug: 1% tropicamide and 10% phenylephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 20 and 80 years old dark iris require binocular indirect ophthalmoscopy for complete ocular examination signed written consent forms Exclusion Criteria: history of ocular trauma history of intraocular surgery history of laser treatment previous eye drop instillation that may affect pupillary dilation ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis history of diabetes mellitus, severe hypertension and cardiovascular diseases

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>single dose vs three doses of 1%tropicamide and 10%phenylephrine | Drug: 1% tropicamide and 10% phenylephrine<br>* single dose vs three doses of 1%tropicamide and 10%phenylephrine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| horizontal pupil diameter |  | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure |  | 30 min | 
| diastolic blood pressure |  | 30 min | 
| heart rate |  | 30 min | 
| adverse drug reaction |  | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
single dose, mydriatic drug, pupillary dilation
Vitamin Metabolism in Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the urinary excretion and renal metabolism of vitamins, in particular vitamin B12 and folate, in relation to various renal conditions involving loss of renal function and/or proteinuria.

Official Title
-----------------
Vitamin Metabolism in Kidney Disease

Conditions
-----------------
Kidney Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to the Department of Nephrology, Aalborg Hospital Elevated serum creatinine Proteinuria Informed and written consent Control subjects: Normal serum creatinine and creatinine clearance No proteinuria Exclusion Criteria: Vitamin supplementation (exceeding predefined values) Renal replacement therapy (dialysis)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CKD<br>Elevated se-creatinine + proteinuria | |
| Healthy controls<br>Healthy controls, normal se-creatinine, no proteinuria | |

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
-----------------
Vitamin B12, Folic Acid
Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that in patients with shift work sleep disorder, armodafinil will specifically increase brain activity in the frontal cortex parallel with improvements in deficits of fundamental mechanisms of attention.

Detailed Description
-----------------
The current protocol will utilize a paradigm which is well suited to examine frontal attentional neuronal mechanisms by eliciting event related potential components known to reflect automatic stimulus detection as well as involuntary and voluntary attentional processes. The that end the proposed research has two specific aims. 1) Identify what areas of the frontal lobe and corresponding cognitive functions are impacted by excessive sleepiness in shift work sleep disorder and 2) identify specific brain areas affected by armodafinil and their role in improvement of fundamental attentional processes using a complex cognitive task targeting attentional control.

Official Title
-----------------
Magnetoencephalographic Imaging of Sleepiness: The Effect of Armodafinil in Shift Work Sleep Disorder

Conditions
-----------------
Shift Work Sleep Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Night shift workers with and without shift work sleep disorder. Exclusion Criteria: Secondary condition to shift work sleep disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Individuals with shift work sleep disorder | |
| 2<br>Healthy night shift workers without shift work sleep disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: T4020
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients diagnosed with progressive keratoconus Patients who signed and dated informed consent Exclusion Criteria: Patient under 18 years History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess Corneal thickness< 400µm

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T4020<br>1 drop every other day during 5 days | Device: T4020<br> <br> |
| Placebo Comparator: Saline solution<br>1 drop every other day during 5 days | Device: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3 |  | Day 3 | 
| Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4 |  | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Epithelial Defect Size Assessment |  | Baseline and Day 5 | 
| Number of Participants With Treatment-emergent Adverse Events |  | Through study completion, an average of 1 month |
Tranexamic Acid for the Latarjet Procedure.

Study Overview
=================
Brief Summary
-----------------
The investigators propose a double-blinded randomized study evaluating the effectiveness of tranexamic acid in reducing postoperative swelling and haematoma formation after the Latarjet procedure. The purpose of this study is to assess the efficacy of tranexamic acid (TXA), given via intra-articular injection at the time of surgery in patients undergoing the Latarjet procedure for shoulder instability.

Official Title
-----------------
A Randomised, Prospective Evaluation on the Effectiveness of Tranexamic Acid in Reducing Postoperative Swelling and Haematoma Formation After the Latarjet Procedure.

Conditions
-----------------
Anterior Shoulder Instability

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Anterior shoulder instability, warranting the Latarjet procedure Exclusion Criteria: Patients with known risk factors for hyper-coagulable state Patients under 16 Patients unable to give consent to partake in the trial

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Tranexamic Acid 1g IV | Drug: Tranexamic Acid<br>* 1g Tranexamic acid prior to skin incision<br>|
| Placebo Comparator: Group B<br>Saline injection | Drug: Saline<br>* Equivalent volume of saline prior to skin incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma Formation | Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4) | Postoperative day-1 | 
| Visual Analogue Scale |  | Postoperative day-1 | 
| Total Drain output | The total drain output of blood post-operatively | Postoperative day-1 | 
| Opioid consumption |  | Postoperative day-1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complications |  | Postoperative week-2 | 
| Total complications |  | Postoperative month-4 | 
| Haematoma Formation |  | Postoperative week-2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tranexamic acid, anterior shoulder instability, latarjet, hematoma