linjc16/ctgov huggingface dataset:
Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

Study Overview
=================
Brief Summary
-----------------
Several aspects on the use of portal vein embolization (PVE) are poorly studied and todays recommendations are based on low-grade evidence. In this Scandinavian multicenter cohort study we will study some of the controversial aspects on the use of PVE to try to provide clearer answers on its optimal use. Six tertiary university hospital hepatobiliary units in Sweden, Norway and Denmark participate and contribute with all PVE procedures performed at their units during the study period. We will then study several aspects PVE technique in relation to induced hypertrophy and surgical outcome.

Official Title
-----------------
Scandinavian Cohort Study for Optimal Use of Portal Vein Embolization

Conditions
-----------------
Hepatic Neoplasm

Intervention / Treatment
-----------------
* Procedure: Portal vein embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right-sided PVE Exclusion Criteria: Left-sided PVE

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 |
| --- | --- |
| rPVE<br>Right portal vein embolization. All patients subjected to selective right portal vein embolization prior to planned hepatobiliary surgery. | Procedure: Portal vein embolization<br>* Selective preoperative portal vein embolization<br>|
| rPVE+S4<br>Right portal vein embolization including segment 4 portal vein branches. All patients subjected to selective right portal vein embolization including segment 4 portal vein branches prior to planned hepatobiliary surgery. | Procedure: Portal vein embolization<br>* Selective preoperative portal vein embolization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Future liver remnant hypertrophy | Increase in future liver remnant, (%) | Based on radiology around 4 weeks before and after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of segment 4 embolization on hypertrophy | Increase in future liver remnant (%) dependeing on if segment 4 is embolized or not. | Based on radiology around 4 weeks before and after intervention | 
| Effect of hyperbilirubinemia on hypertrophy | Increase in future liver remnant (%) dependeing on the levels of bilirubin before portal vein embolization. | Based on radiology around 4 weeks before and after intervention | 
| Effect of sarcopenia on hypertrophy | Increase in future liver remnant (%) dependeing on the level of sarcopenia before portal vein embolization. | Based on radiology around 4 weeks before and after intervention |
Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: Assess the efficacy of a single infusion of a high titer pertussis immune globulin for the treatment of severe pertussis in children.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive an infusion of either pertussis immune globulin or placebo (0.9% saline). Patients are followed every 2 weeks for up to 6 months. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Pertussis, Whooping Cough

Intervention / Treatment
-----------------
* Drug: immune globulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Documented infection with Bordetella pertussis

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: immune globulin|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
-----------------
bacterial infection, immunologic disorders and infectious disorders, pertussis, rare disease
Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.

Official Title
-----------------
Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: ear vagus nerve stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as epilepsy; With age between 2-18 years old; The number and dose of the medication was kept constant no less than eight weeks before intervention; The patients or their guardians can count the frequency of the seizures and finish the study. Exclusion Criteria: The patient is receiving the VNS therapy; Accompanied with progressive central nervous system diseases; Have severe heart, liver ,kidney or blood diseases; Be pregnant or having the schedule of pregnancy in the study period.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcutaneous auricular vagal stimulation<br>Transcutaneous stimulation at auricular concha | Device: ear vagus nerve stimulator<br> <br> |
| Sham Comparator: Transcutaneous auricular non-vagal stimulation<br>Transcutaneous stimulation at auricular edge | Device: ear vagus nerve stimulator<br> <br> |
| No Intervention: control<br>No transcutaneous stimulation is given | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of epileptic seizures |  | Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric epilepsy, transcutaneous vagus nerve stimulation
Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion

Study Overview
=================
Brief Summary
-----------------
Dental erosions, the chemical dissolution of enamel without bacterial involvement, are considered to be an established complication of gastroesophageal reflux disease (GERD) by the Montreal global consensus statement. Given the high prevalence of dental erosions and the absence of any pH-impedance data or medical management guidelines for GERD-associated dental erosions, reflux characteristics will be characterized using questionnaires, endoscopy and esophageal pH-impedance testing, in successive patients dental erosions referred by dentists for evaluation of GERD. For assessment of the role of additional factors besides H+ activity in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg twice-daily, which is prescribed to all patients.

Official Title
-----------------
Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion: a Longitudinal Study With pH-impedance Monitoring

Conditions
-----------------
Dental Erosion, Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Successive male and female patients Over 18 years of age presenting to the University of Bern Department of Dentistry and affiliated dentists Dental erosions Exclusion criteria: Non-reflux causes of erosion Reduced salivary flow and buffering capacity History of bruxism, eating disorders, recurrent vomiting, severe obesity (BMI>35kg/m2) or past bariatric surgery Dietary or abrasive causes for dental erosion

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 |
| --- | --- |
| Dental erosions<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The % of time with pH<4 and 5.5 during 24-hour pH-impedance |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance |  | 1 year |
Burst Suppression Anesthesia for Treatment of Severe Depression

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to EEG burst suppression.

Detailed Description
-----------------
Ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. Depression will be evaluated before and after treatment.

Official Title
-----------------
Burst Suppression Anesthesia for Treatment of Severe Depression

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Diprivan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Diagnosis of Major Depressive Disorder (MDD) or bipolar Disorder (I or II, most recent episode must be depression Failed at least 2 anti-depressant treatments and no ECT in past 6 months Age between 18-55 years BMI < 35 Hamilton Rating Scale for Depression (HSRD) score > 18 Quick Inventory of Depression Scale (QIDS) score > 10. Exclusion Criteria: • Diagnosis of primary psychotic disorder, dysthymia, or personality disorder Significant pre-morbid cognitive impairment Hypertension and current use of ACE inhibitor or AR blocker medications Symptomatic coronary artery disease or congestive heart failure History of transient ischemic or neurologic signs during the past year History of or susceptibility to malignant hyperthermia Contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist) Diabetes requiring insulin Poor kidney function Chronic use of benzodiazepines or opioids Individuals incompetent to provide consent (e.g. catatonic, psychotic).

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

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

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

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: Propofol<br>Participants will receive intravenous propofol titrated rapidly at 100-200 mcg/kg/min to reach 80% burst-suppression and then maintained there for 15 minutes, after which propofol administration will be discontinued and the participant will be allowed to awaken. | Drug: Diprivan<br> <br> * Other names: Propofol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptoms |  | 3 weeks |
Validation of Ventriject Determined Maximal Oxygen Uptake

Study Overview
=================
Brief Summary
-----------------
This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography.

Detailed Description
-----------------
this study will be composed of the following tests: blood sample for measurement of blood values blood pressure measurement to rule out risks affiliated with maximal effort testing DXA body composition scanning Measurement on ECG, echosonography and echoseismography with accelerometer, microphone and ECG wires Measurements with phone (iPhone) VO2 max assessment by maximal oxygen uptake testing on a training bike, using online oxygenmeasurement equipment Hand-grip strength assessment

Official Title
-----------------
Validation of Ventriject Determined Maximal Oxygen Uptake

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Ventriject validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - healthy adults between 18 and 45 years of age Exclusion Criteria: current or previous cardiovascular disease chronic use of medicine pregnancy illnesses which prohibits the testing of maximal oxygen uptake

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ventriject validation|comparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing how well the Ventriject software can estimate VO2 max | VO2 max tested on bike with online software Ventriject will estimate VO2max based on ECG, echoseismography and echosonography obtained at rest | 4 months data collection, although cross sectional | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparing how well the measurements from the mobile phone test compare to the same measurements with accelerometer and echosonography | comparison of ECG, echoseismography and echosonography obtained at rest to a measurement of movement (caused by heart contraction) by mobile phone, also at rest | 4 months data collection, although cross sectional |
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus to Treat Cancer

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.

Official Title
-----------------
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus

Conditions
-----------------
Melanoma, Liver Cancer, Pancreatic Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis. lack of routine effective treatment,failure of routine treatment or relapse age of 18-70,ECOG 0-2 and estimated survival is above 3 months had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C. Exclusion Criteria: Serious internal diseases uncontrolled primary and metastatic brain tumor sizes of tumor does not meet the requirement of injection

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant HSV-1 Injection<br>Intratumoral injection Single dose: 4 groups -- 106 pfu, 107 pfu, 108 pfu and 4×108 pfu Multiple dose (three injections, every 2 weeks): 2 groups -- 108, 108, 108pfu and 4×108, 4×108, 4×108pfu Continuous treatment: Upon 4 weeks follow-up after administration, if the investigator deems that continuous treatment will benefit subjects, continuous intratumoral injection may be given, and the interval between each injection will be 2 weeks. | Biological: Recombinant hGM-CSF Herpes Simplex Virus Injection<br> <br> * Other names: OrienX010;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03 |  | 28 days after the last administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010 |  | 28 days after the last administration |
Natural History Clinical Study in Adult PKU

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to characterize the natural history of phenylketonuria (PKU) due to phenylalanine hydroxylase (PAH) deficiency in adults through prospective collection of clinical, cognitive, and quality of life assessments.

Detailed Description
-----------------
Phenylalanine hydroxylase (PAH) deficiency is a rare disease caused by an inborn error of metabolism. If left untreated, PAH deficiency results in progressive, irreversible neurological impairment during infancy and early childhood. This study is designed to collect information about important PKU-related symptoms and tests to characterize the natural history of PKU due to PAH deficiency in a selected sample of adults. No new investigational treatment will be administered to participating patients.

Official Title
-----------------
A Prospective Study Investigating the Natural History of Adults With Phenylketonuria (PKU) Due to Phenylalanine Hydroxylase Deficiency

Conditions
-----------------
Phenylketonurias, PKU

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Aged 18-55 years at the time of informed consent Diagnosis of PKU due to PAH deficiency One plasma Phe value with a concentration of ≥ 600 μmol/L drawn at Screening and at least 1 historical Phe value ≥ 600 μmol/L in the preceding 12 months Key Exclusion Criteria: Subjects with PKU that is not due to PAH deficiency Alanine aminotransferase (ALT) > 1.5x upper limit of normal (ULN) and aspartate aminotransferase (AST) >1.5x ULN Alkaline phosphatase > 1.5x ULN Total bilirubin > 1.5x ULN, direct bilirubin ≥ 1.5x ULN, unless associated with Gilbert's syndrome. Serum creatinine > 1.5x ULN Hematology values outside of the normal range (hemoglobin < 11.0 g/dL for males or < 10.0 g/dL for females; white blood cells (WBC) < 3,000/μL; absolute neutrophils < 1,500/μL; platelets < 100,000/μL) Hemoglobin A1c > 6.5% or fasting glucose > 126 mg/dL Any clinically significant abnormal laboratory result at Screening, as determined by the Investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Plasma phenylalanine (Phe) concentrations | Change in plasma Phe concentrations throughout study duration | Baseline to Week 52 | 
| Plasma tyrosine (Tyr) concentrations | Change in plasma Tyr concentrations throughout study duration | Baseline to Week 52 | 
| Quality of life (QOL), as assessed using the PKU-QOL questionnaire measures | Changes in PKU-QOL | Baseline to Week 52 |