linjc16/ctgov huggingface dataset:
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

Study Overview
=================
Brief Summary
-----------------
This study will be done to investigate perioperative lidocaine infusion on neutrophil extracellular trapping in the patients undergoing the robot-assisted prostatectomy.

Detailed Description
-----------------
Neutrophil extracellular trapping by analyzing the meyloperoxidase, neutrophil elastase, citrullinated histone3

Official Title
-----------------
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping in the Patients Undergoing the Robot-assisted Prostatectomy

Conditions
-----------------
Urologic Cancer

Intervention / Treatment
-----------------
* Drug: lidocaine group
* Drug: control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled robot-assisted prostatectomy Exclusion Criteria: lidocaine allergy Hx hemodynamic unstable patients weight < 40kg arrhythmia or bradycardia

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lidocaine group<br>The study group receives perioperative lidocaine infusion with general anesthesia for robot-assisted prostatectomy | Drug: lidocaine group<br>* lidocaine 1.5 mg/kg bolus (infused over 10 min) followed by 2.0 mg/kg/h during operation and 1.0 mg/kg/h during postoperative 24 hours (no more than 120 mg/h)<br>* Other names: lidocaine;|
| Placebo Comparator: control group<br>The control group receives normal saline infusion with with general anesthesia for robot-assisted prostatectomy | Drug: control group<br>* normal saline 0.15 ml bolus followed by 0.2 ml/kg/hr during operation and 0.1 ml/kg/hr during postoperative 24 hours<br>* Other names: normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of citrullinated histone3 | This will be obtained using ELISA. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of meyloperoxidase | This will be obtained using ELISA. | 24 hours after surgery | 
| Concentration of neutrophil elastase | This will be obtained using ELISA. | 24 hours after surgery |
Evaluation of Kinesophobia in Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome (MS) is a public health problem characterized by central obesity, increased blood pressure and triglyceride levels, decreased blood HDL levels and the presence of insulin resistance (1).Kinesiophobia is a fear of irrational movement that develops because of its belief in susceptibility to injury and is associated with low levels of physical activity. Considering that exercise improves metabolic processes in people with MS, we aimed to evaluate the presence of kinesophobia in patients with MS. Patients aged 45-65 years diagnosed with metabolic syndrome and healthy controls will be included in the study. Patients with rheumatic and neurological diseases,history of trauma, gonarthrosis, lumbar disc hernia, previous fractures, fibromyalgia and those who have experienced pain for the last week will be excluded. The participants will be filled in the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale, and the Tampa Kinesiophobia Scale. 48 patients with MS and 48 healthy participants will be included in the study.

Official Title
-----------------
Evaluation of Kinesophobia in Patients With Metabolic Syndrome

Conditions
-----------------
Kinesiophobia, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Kinesiophobia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metabolic syndrome Exclusion Criteria: Patients with rheumatic disease Patients with neurologic disease Patients with history of trauma Patients with gonartrosis Pateints with fibromialgia

Ages Eligible for Study
-----------------
Minimum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with metabolic syndrome<br> | Other: Kinesiophobia<br>* The presence of kinesiofobia in patients with metabolic syndrome<br>|
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Kinesiophobia Scale | People takes between 17-68 total a score. The score of the person shows high kinesiophobia on the scale | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kinesiophobia, metabolic syndrome, exercise
Accuracy Comparison of Two CGMs in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the accuracy of two different continuous blood sugar monitoring systems in hospitalized patients by comparing them standard laboratory blood sugar testing in the hospital.

Official Title
-----------------
Comparative Accuracy of Two Subcutaneous Continuous Glucose Monitoring Devices in Hospitalized Patients Requiring Continuous Intravenous Insulin Infusion

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All genders, admitted to UC San Diego Hillcrest Medical Center with an anticipated remaining length of stay of ≥24 hours Age ≥18 years at the time of consent Requiring standard of care intravenous insulin infusion therapy at the time of consent with an anticipated duration of intravenous insulin infusion ≥12 hours Willingness to provide informed consent and follow all study procedures Exclusion Criteria: Current bleeding disorder, treatment with anticoagulants, or platelet count below 50,000/mL at enrollment Lack of appropriate sites for sensor placement (sites must be free of scars, skin irritation, surgical wounds, dressings, etc.) Planned magnetic resonance imaging (MRI) study within 24 hours of enrollment Any other condition that, based on Investigator's judgment, would jeopardize patient safety during trial participation or would affect the study outcome

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 |
| --- | --- |
| ICU<br>ICU patients on insulin drip | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in glucose measurement | Difference between glucose as measured by continuous glucose monitor versus laboratory | 5 Days |
Cesarean Wound Closure: Dermabond Versus Steri Strips

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision

Official Title
-----------------
Cesarean Wound Closure: Dermabond Versus Steri Strips

Conditions
-----------------
Scar

Intervention / Treatment
-----------------
* Other: Dermabond
* Other: Steri Strips


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health Gestational age > 24 weeks Planned Pfannenstiel incision Willing to consent to the study Exclusion Criteria: Emergency or urgent cesarean section Vertical skin incision Intrapartum intraamniotic infection Diabetes Unwilling to consent to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steri Strips Arm<br> | Other: Steri Strips<br>* Steri Strips will be applied after subcuticular skin closure as routinely done at our institution<br>|
| Experimental: Dermabond Arm<br> | Other: Dermabond<br>* Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale Surveys (POSAS) | Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin. | at 1 weeks postpartum | 
| Patient and Observer Scar Assessment Scale Surveys | Validated scale comparing a scar to normal skin. Score ranges from 6 to 60 with the higher numbers less like normal skin. | at 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with wound infection |  | through 6 weeks postpartum | 
| Number of patients with wound separation or dehiscence |  | through 6 weeks postpartum |
Pre/Term Milk Profiling

Study Overview
=================
Brief Summary
-----------------
This study aims for an in-depth characterization of human milk of mothers who delivered prematurely to decipher differences with milk of mothers who delivered at the expected term, with a particular focus on milk proteins

Official Title
-----------------
Longitudinal Composition of Human Milk for Term and Preterm Infants

Conditions
-----------------
Preterm Milk, Term Milk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having obtained informed consent Group 1 (term delivery): Gestational age between 37 0/7 and not above 41 6/7 weeks Group 2 (preterm delivery): Gestational age between 28 0/7 and 32 6/7 weeks Age: Mother ≥ 18 years old Partial or total breast feeding Having a freezer compartment at home (approx. -18°C) Good understanding of the French language Exclusion Criteria: Suffering from diabetes (type I or II) before pregnancy Alcohol consumption: more than 1 standard drink / day Drug addicted Subject who cannot be expected to comply with the study procedures. Currently participating in an interventional therapeutic clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Subject delivering preterm baby<br> | |
| Subject delivering term baby<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total protein concentration in human milk |  | from delivery, up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total lipids and carbohydrates |  | From delivery, up to 4 months | 
| Determination of Calcium and Phosphorous content |  | From delivery, up to 4 months | 
| Determination of peptide profiles and content |  | From delivery, up to 4 months | 
| Determination of miRNA content |  | From delivery, up to 4 months |
A Study Evaluating the Effects of Nebivolol on Blood Pressure in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of various doses of nebivolol in patients with mild to moderate hypertension.

Detailed Description
-----------------
This was a multi-center, randomized, double-blind, parallel group, placebo-controlled study of nebivolol over a range of doses in patients with mild to moderate hypertension. The study consisted of 2 phases: screening/washout/single-blind placebo run-in followed by randomization/double-blind treatment. During the double-blind phase, patients received nebivolol or placebo. Patients had 7 scheduled clinical visits during the study.

Official Title
-----------------
A Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Parallel Group Dosing Study Evaluating the Effects of Nebivolol on Blood Pressure in Patients With Mild to Moderate Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nebivolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An average sitting diastolic blood pressure of greater then or equal to 95 mmHg and less then or equal to 109 mmHg at baseline Exclusion Criteria: Recent myocardial infarction or stroke Secondary hypertension Contraindications to beta-blocker treatment or discontinuation of current antihypertensive therapy Pregnancy, nursing, or women of child-bearing potential not using appropriate contraception

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nebivolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the average sitting diastolic blood pressure taken at trough drug plasma level at the end of treatment compared to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Sitting SBP |  |  | 
| - Supine SBP and DBP |  |  | 
| - Standing SBP and DBP |  |  | 
| - Response rate |  |  | 
| - Correlation between plasma levels |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebivolol, Hypertension, Beta-Blocker
Dermatologic Manifestations of Zika Virus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.

Detailed Description
-----------------
The study has both retrospective and prospective components. The retrospective review includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective component will enroll adults presenting with febrile illness and rash and ask them to complete a survey about their symptoms. Diagnostic testing will be completed to confirm infection source.

Official Title
-----------------
Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus

Conditions
-----------------
Zika Virus Symptoms and the Associated Exanthema

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 years and older presenting with febrile illness and rash Exclusion Criteria: Patients aged 17 years or younger

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|18 question symptom assessment tool including non-identifying demographic information questions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with specific symptoms | Number of days reported experiencing specific symptoms due to Zika Virus infection and and associated characteristics such as location and intensity | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency measures of initial clinical presentations | Frequency of reported symptoms at initial clinical presentation. | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zika Virus
Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers

Study Overview
=================
Brief Summary
-----------------
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.

Detailed Description
-----------------
To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.

Official Title
-----------------
Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers

Conditions
-----------------
Blood, Injection, Injury Type Phobia, Gastrointestinal Ulcer Haemorrhage, Adverse Reaction to Epinephrine

Intervention / Treatment
-----------------
* Drug: Epinephrine
* Biological: Blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients with gastroduodenal ulcer Exclusion Criteria: Patients with non ulcer bleeding. Patients with malignancy. Patients with bleeding disorders or under coagulation therapy. Patients with known allergy to epinephrine.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous blood<br>Patients will be injected by autologous blood at the edge of actively bleeding ulcer | Biological: Blood<br>* 5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.<br>|
| Other: Epinephrine injection<br>Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer | Drug: Epinephrine<br>* 10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl). |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autologous blood, epinephrine, endoscopy, ulcer, hemostasis
Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.

Conditions
-----------------
Sleep Quality, Extubation Failure

Intervention / Treatment
-----------------
* Other: Polysomnography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intensive care units patients intubated for at least 24 hours with at least on of the four following risk factor : aged of 65 years or more, any underlying chronic cardiac or lung disease, mechanical ventilation for more than 7 days. aged of 18 years or more Exclusion Criteria: peripheral or central nervous system pathology known psychiatric pathology or agitation patient with decision of no reintubation patient refusal clinical worsening before polysomnography ( shock with vasopressors drugs, coma, PaO2/FiO2 ratio < 150 with respiratory distress signs, coma with Glasgow scale <8) pregnant or breastfeeding women patient under legal guardianship or protection patient with no health insurance coverage aged < 18 years

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Polysomnography|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sleep quality by polysomnography recording on the extubation day. |  | 24 hours |