linjc16/ctgov huggingface dataset:
Developing Viability Index for Machine Perfused Livers

Study Overview
=================
Brief Summary
-----------------
Machine perfusion technology is nearing the point of rescuing discarded liver grafts in the hope of proving them to be or improving them to the point of being transplantable. However, there are no validated metrics to determine transplantability after machine perfusion. This study involves collecting biopsies from transplanted livers before and after implantation to correlate metabolite and gene expression with post-transplant function. This data will help develop a viability index for machine perfused livers.

Official Title
-----------------
Development of a Liver Viability Index for Transplantation

Conditions
-----------------
Liver Cirrhoses

Intervention / Treatment
-----------------
* Diagnostic Test: Liver Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18-75 years of age. Candidate for a deceased-donor liver allograft. Exclusion Criteria: Seropositivity for HIV-1.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsy<br>Biopsies taken at protocol specified time points | Diagnostic Test: Liver Biopsy<br>* For measurement of tissue co-factor levels, we will take needle biopsies of transplanted livers immediately after procurement, immediately prior to implantation (at the end of preservation), 30 minutes after portal vein reperfusion, and 30 minutes after hepatic artery reperfusion. For those livers that have more than 60 minutes between portal vein and hepatic artery reperfusion, an additional biopsy will be performed at 60 minutes after portal vein reperfusion. Post-procurement biopsies will be collected regardless of where the liver was obtained.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak transaminase value post transplant | The primary endpoint is peak transaminase values since transaminase elevation is a marker of hepatocyte injury | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Liver Rejection |  | 1 Year | 
| Incidence of major Infection |  | 1 Year | 
| Hepatitis C Recurrence (in Hepatitis C positive recipients) |  | 1 Year | 
| Kidney Failure |  | 1 Year | 
| Biliary Complications |  | 1 Year | 
| Liver Graft Failure |  | 1 Year | 
| Death |  | 1 Year |
Biomarkers And Neurological Outcome in Neonates 2

Study Overview
=================
Brief Summary
-----------------
Follow-up of participants of BANON1 study at age of at least 2 years. BANON1 (ClinicalTrials.gov ID: NCT03357250): Validation of biomarkers based on 24 months neuro-developmental outcome data in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

Detailed Description
-----------------
Follow-Up on neuro-developmental status of Study participants of BANON1. BANON1 (ClinicalTrials.gov ID: NCT03357250): The aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

Official Title
-----------------
Validation of Biomarkers of Adverse Neurologic Outcome in Newborns at Risk for Perinatal Brain Injury - Study on Neuro-developmental Follow-up at 2 Years A Prospective Multicenter Observational Study for Development of a Diagnostic Test

Conditions
-----------------
Asphyxia Neonatorum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants previously enrolled in BANON study Exclusion Criteria: Missing valid written informed parental consent

Ages Eligible for Study
-----------------
Minimum Age: 22 Months
Maximum Age: 48 Months

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 |
| --- | --- | --- |
| participants with normal neuro-developmental status | all infants with normal neuro-developmental status | up to 42 month age | 
| participants with potentially abnormal neuro-developmental status | All infants who do not fulfill outcomes 1, 3 or 4 | up to 42 month age | 
| participants with abnormal neuro-developmental status - HIE | Presence of adverse 2 years neuro-developmental outcome likely attributable to perinatal hypoxic-ischemic brain injury | up to 42 month age | 
| participants with abnormal neuro-developmental status - non-HIE | Presence of adverse 2 years neuro-developmental outcome not attributable to perinatal hypoxic-ischemic brain injury | up to 42 month age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomarkers, Asphyxia, Hypoxic ischemic encephalopathy
Comparative Performance of PureVision, Acuvue Oasys and O2Optix

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the performance of the PureVision Contact Lens compared to Acuvue Oasys Contact lens and O2Optix Contact lens when worn on a daily wear basis.

Official Title
-----------------
Product Performance of Bausch & Lomb PureVision® Contact Lens When Compared to Johnson & Johnson Acuvue Oasys Contact Lens and the Ciba Vision O2Optix Contact Lens Worn Daily.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: PureVision Contact Lens
* Device: Acuvue Oasys Contact Lens
* Device: O2Optix Contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is myopic VA correctable to 0.3 LogMAR or better (driving vision) Clear central cornea Subject uses a lens care system on a regular basis Exclusion Criteria: Systemic disease affecting ocular health Using systemic or topical medications Wear monovision, multifocal or toric contact lenses Any grade 2 or greater slit lamp findings

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PureVision<br>PureVision Contact Lens | Device: PureVision Contact Lens<br>* contact lens for daily wear<br>|
| Active Comparator: Acuvue Oasys<br>Acuvue Oasys Contact Lens | Device: Acuvue Oasys Contact Lens<br>* contact lens for daily wear<br>|
| Active Comparator: O2Optix<br>O2Optix Contact Lens | Device: O2Optix Contact lens<br>* contact lens for daily wear<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Slit Lamp Finding > Grade 2 | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates were measured. | Over all follow-up visits for the 1 month study period | 
| Subjective Responses to Comfort-related Symptoms/Complaints | Subjective ratings of symptoms/complaints using a scale of 0 = Severe Stinging/Burning to 100 = No Stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating. | Over all follow-up visits for 1 month study period | 
| Uncorrected Distance High Contrast Visual Acuity | logMAR high contrast visual acuity (VA) over all visits. | Over all visits for the 1 month study period |
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

Official Title
-----------------
Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: rosiglitazone
* Drug: glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treatment with oral anti-diabetic drugs for at least 3 months HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy Body Mass Index (BMI) less than or equal to 45.0 kg/m2. Exclusion Criteria: Treatment with insulin within the last three months Treatment with any drug that could interfere with the glucose level Any serious medical condition Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liraglutide|nan|
|Drug: rosiglitazone|nan|
|Drug: glimepiride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  |  | 
| Safety and tolerability |  |  | 
| beta-cell function |  |  | 
| Glycemic control parameters (fasting plasma glucose, -glucose profiles) |  |  |
Amlodipine/Atorvastatin Combination to Reduce the Health Risk of High Blood Pressure and High Cholesterol Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure the effect of the amlodipine/atorvastatin combination pill in reducing both elevated blood pressure and cholesterol levels to levels suggested by guidelines

Official Title
-----------------
Clinical Utility of Amlodipine/Atorvastatin to Improve Concomitant Cardiovascular Risk Factors of Hypertension and Dyslipidemia

Conditions
-----------------
Hypertension, Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Amlodipine/atorvastatin single pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of both elevated blood pressure and low density lipoprotein cholesterol levels, requiring medication Exclusion Criteria: Patients with blood pressure adequately maintained at goal with or without medication Patients currently treated with both amlodipine and atorvastatin or not at blood pressure or lipid level while taking the highest dose of amlodipine or atorvastatin, respectively

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amlodipine/atorvastatin single pill|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of amlodipine/atorvastatin therapy by assessing the percentage of intent-to-treat subjects achieving both BP and lipid treatment goals (JNC VII and NCEP ATP III) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes from baseline in lipid profile and systolic and diastolic BP after 14 weeks treatment; and in this secondary and the primary objectives stratified by prior BP and lipid therapy, and in diabetic subjects; safety |  |  |
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.

Official Title
-----------------
Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants

Conditions
-----------------
Infant, Very Low Birth Weight

Intervention / Treatment
-----------------
* Dietary Supplement: Similac special care 30
* Dietary Supplement: Similac human milk fortifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants between 500 and 1499 grams of birthweight, receiving mother's milk. Exclusion Criteria: Infants with major congenital anomalies and previous history of gastrointestinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 10 Weeks

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Liquid human milk fortifier | Dietary Supplement: Similac special care 30<br>* Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.<br>|
| Active Comparator: 2<br>Powdered human milk fortifier | Dietary Supplement: Similac human milk fortifier<br>* Powdered human milk fortifier.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily. |  | 2 - 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay and feeding intolerance |  | 2-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low birth weight, neonates, premature infants, nutrition, human milk fortification, Infant
Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.

Detailed Description
-----------------
After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol. Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications. Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.

Official Title
-----------------
Safety and Efficacy of GPOEM in the Treatment of Gastroparesis

Conditions
-----------------
Gastroparesis, Gastroparesis Postoperative, Gastroparesis With Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: GPOEM - gastric per-oral endoscopic myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gastroparesis (GCSI > 2 OR Gastric emptying half-time > 180 min OR gastric retention at 120 min > 60% OR good response to botulinum if former criteria not met) Exclusion Criteria: Age < 18 years Inability to understand protocol

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: GPOEM - gastric per-oral endoscopic myotomy|Endoscopic section of the pyloric muscle with submucosal tunnel technique.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy | Change in symptomatological scores | 1, 3, 6, 12, 24 months | 
| Functional efficacy | Change of scintigraphy evaluated gastric emptying time | 3, 12, 24 months | 
| Complications | Evaluation of the operative adverse events | peri-operative time (48 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of symptoms | Evaluate the correlation between symptoms and gastric emptying | 3, 12, 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GPOEM, gastroparesis, pyloromyotomy
An Observational Study of Insulin Aspart and, if Necessary, Insulin Levemir (FlexPen®) in the Evening or at Bedtime

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.

Official Title
-----------------
The Physiological Therapy of Type 2 Diabetes - NovoRapid® FlexPen® Before Meals, Additionally Levemir® FlexPen® in the Evening or at Bedtime if Needed

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes OAD monotherapy OAD combination therapy Therapy with OAD and basal insulin Conventional insulin therapy with premixed insulin
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SIT<br> | Drug: insulin aspart<br>* Subjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin)<br>Drug: insulin detemir<br>* Insulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose (FBG) |  |  | 
| 2-hours postprandial blood glucose |  |  | 
| Hypoglycemia |  |  | 
| Weight development |  |  | 
| Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs) |  |  |
Refining and Testing the Diagnostic Accuracy of PAT-POPS

Study Overview
=================
Brief Summary
-----------------
Increasing attendances by children (aged 0-16 years) at UK emergency departments (EDs) is putting pressure on the National Health Service (NHS). Health professionals make complex judgements on whether children attending EDs can be sent home safely or require admission. The Pennine Acute Hospitals (PAT) Paediatric Observation Priority Score (PAT-POPS) was developed as an ED-specific screening tool for this purpose. A preliminary study showed it to be a potentially effective tool for deciding admission of children from the ED. Therefore, the focus of this study is to refine the original screening tool.

Official Title
-----------------
Refining and Testing the Diagnostic Accuracy of an Assessment Tool (PAT-POPS) to Predict Admission and Discharge of Children and Young People Who Attend an Emergency Department

Conditions
-----------------
Pediatric ALL

Intervention / Treatment
-----------------
* Diagnostic Test: PAT-POPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and young people aged 0-16 years of age who attend the Emergency Department Exclusion Criteria: Patients who are confirmed dead on arrival at the Emergency Department Patients who attend the Emergency Department in cardio-respiratory arrest

Ages Eligible for Study
-----------------
Maximum Age: 16 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children and young people<br>Aged 0-16 years | Diagnostic Test: PAT-POPS<br>* Emergency Department-specific screening tool<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission or discharge |  | 12 months |