linjc16/ctgov huggingface dataset:
Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Study Overview
=================
Brief Summary
-----------------
Urine output and urine drain line pressure were monitored while urine was drained into either: Accuryn Urine Output Monitor (Potrero Medical) OR Criticore Monitor (Bard Medical)

Detailed Description
-----------------
The purpose of this study is to determine the characteristics of urine output and drain line pressure as measured with the Accuryn urinary output monitoring system and urine output as recorded by a commercially available system (Criticore, Bard Medical) when used with a standard Foley catheter and standard urinary drainage tube.

Official Title
-----------------
Evaluation of a Novel Electronic Urine Output Monitor (eUOM)

Conditions
-----------------
Oliguria, Polyuria

Intervention / Treatment
-----------------
* Device: Accuryn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must ≥ 18 years of age Patient has a Foley catheter and urine collection system is in place per standard clinical decision Estimated length of placement of the Foley is 48 hours minimum Burn injury ≥ 20% and ≤ 80% total body surface area (TBSA) Subject or subject's legally authorized representative is able to give informed consent before entering the study Exclusion Criteria: Currently pregnant or breastfeeding Clinical signs or symptoms of a urinary tract infection (UTI) Clinical signs or symptoms of a vaginal infection Currently has bladder or urethral trauma Use of investigational drug/device therapy within the past 4 weeks

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 |
| --- | --- |
| Test- Accuryn Urine Output Monitor<br>Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored. | Device: Accuryn<br>* Accuryn is a novel electronic urine output monitor<br>|
| Control- Critcore Urine Output Monitor<br>A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Output of SOC Device Versus Accuryn | Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube. | 2 - 5 days |
Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Exertional angina is common symptom in patients with severe aortic stenosis (AS) without obstructive coronary artery disease (CAD). Although reduced myocardial flow reserve is one of the proposed explanations for angina, little is known about the pathophysiology. This study aimed that adenosine-stress cardiac magnetic resonance can be used for the assessment of myocardial perfusion reserve and suggest the pathophysiology of development of angina in patients with severe AS without obstructive CAD.

Official Title
-----------------
Reduced Myocardial Flow Reserve in Exertional Angina With Severe Aortic Stenosis and Normal Coronary Arteries: Insight From Prospective Observational Adenosine-stress Cardiac Magnetic Resonance Imaging Study

Conditions
-----------------
Chest Pain, Severe Aortic Stenosis

Intervention / Treatment
-----------------
* Other: Adenosine-stress cardiac magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe AS normal LV ejection fraction (EF ≥ 50%) Exclusion Criteria: age <18 LVEF < 50% in echocardiography concomitant other valvular disease of moderate or severe severity previous aortic valve replacement symptomatic patients other than chest pain obstructive CAD (>30% luminal stenosis in at least one coronary artery on coronary angiography) history of myocardial infarction or acute coronary syndrome contraindication to adenosine any absolute contraindication to CMR estimated glomerular filtration rate <30 mL/min/1.73m2.

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 |
| --- | --- |
| Severe AS: asymptomatic<br>Asymptomatic | Other: Adenosine-stress cardiac magnetic resonance imaging<br>* undergoing adenosine-stress cardiac magnetic resonance imaging<br>|
| Severe AS: pure angina<br>Presence of exertional chest pain | Other: Adenosine-stress cardiac magnetic resonance imaging<br>* undergoing adenosine-stress cardiac magnetic resonance imaging<br>|
| Normal controls<br>Healthy controls | Other: Adenosine-stress cardiac magnetic resonance imaging<br>* undergoing adenosine-stress cardiac magnetic resonance imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Values of the myocardial perfusion reserve index (MPRI) | Signal intensity-time curves were generated for all segments and the maximum upslope of the LV myocardium divided by the maximum upslope of the LV cavity. MPRI [upslopestress(corrected)/upsloperest(corrected)] was calculated dividing the segmental upslope value during adenosine and rest. Whole (average of all myocardial segments) MPRI were calculated. | Day 1 |
An Extension Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

Study Overview
=================
Brief Summary
-----------------
This is an extension study of HCV-05-002. The objective of this study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for an additional 36 weeks in patients with chronic hepatitis C genotype 1 infection.

Official Title
-----------------
A Phase II, Multi-Center, Extension Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With or Without Ribavirin, for an Additional 36 Weeks

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: Celgosivir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed HCV-05-002 only 18-65 years of age, inclusive Primary diagnosis of chronic HCV infection Non-responders to previous pegylated interferon-based therapy Exclusion Criteria: Patients naive to interferon-based therapy for chronic HCV infection

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety analysis |  |  | 
| HCV viral load reduction from baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Celgosivir, HCV, Genotype 1, Non-responders, End of Treatment Response, Sustained Viral Response
Narrowband UVB Treatment in Patients With Vitiligo

Study Overview
=================
Brief Summary
-----------------
The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo. The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.

Detailed Description
-----------------
All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.

Official Title
-----------------
Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Device: Narrowband UVB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years of age or greater Vitiligo with extensive skin involvement (>5% body surface affected). Exclusion Criteria: No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study. No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitiligo<br>adult patients (age 18 or greater) with extensive vitiligo warranting treatment with whole body NB-UVB | Device: Narrowband UVB<br>* Treatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of melanocytes per unit length of skin surface |  | pre-treatment, early repigmentation, 75% repigmentation of total body | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement |  | first visit and last visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narrowband UBV Phototherapy, Skin biopsies
Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.

Official Title
-----------------
Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with diabetes type 2 diabetes Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient Exclusion Criteria: Known or suspected allergy to study product(s) or related products Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: NovoMix® 30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions, including major hypoglycaemic events |  | after 12 and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all hypoglycaemic events |  | in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks | 
| Number of all adverse drug reactions |  | after 12 and 26 weeks | 
| HbA1c |  | at 12 and 26 weeks | 
| Variability in fasting plasma glucose (FPG) values and average FPG levels |  | at visits at 12 and 26 weeks | 
| Weight changes |  | at visits at 12 and 26 weeks |
Treatment for Cubital Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
The researchers want to find out the best treatment for cubital tunnel. The researchers establish the degree of nerve compression and then the patients are randomised to different treatment alternatives, ranging from conservative to operative treatments. The study is performed at 5 different hospitals in Norway.

Official Title
-----------------
Cubital Tunnel Treatment, Evaluation of Conservative and Operative Alternatives

Conditions
-----------------
Cubital Tunnel Syndrome

Intervention / Treatment
-----------------
* Procedure: decompression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cubital tunnel syndrome Exclusion Criteria: Rheumatoid arthritis (RA) Osteoarthrosis Varus or valgus deformities at elbow
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

| Intervention/Treatment |
| --- |
|Procedure: decompression|Conservative, simple decompression and nerve transfer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electroneurography (ENG | electroneurography (ENG) before and after the operation and to see if it is consistent with the patient evaluation. |  | 
| paresthesia |  |  | 
| weakness |  |  | 
| patient satisfaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment, Cubital tunnel, nerve compression
A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
Observational prospective study. Patients with DLBCL and HGBCL will be enrolled in the study to collect samples for developing a blood based assay allowing biomarker driven treatment in the future.

Detailed Description
-----------------
The rationale of this study is that, due to the lack of successful salvage options, first-line treatment outcome needs to be improved. To make this possible, a crucial condition is optimal identification of patients that will not be cured on R-CHOP. The aim of this protocol is to develop new tools to monitor treatment response and disease outcome. Molecular monitoring of treatment response through liquid biopsies (LB) is such a promising new tool. The primary objective is to collect liquid biopsy samples of patients with newly diagnosed DLBCL/HGBCL to develop a blood based assay allowing biomarker driven treatment in the future. The secondary objectives are to collect clinical data and pre-treatment tissue samples (for determining molecular profiles) to allow for correlation to the blood based assay. This study is designed for patients with newly diagnosed DLBCL and HGBCL ≥ 18 yr.

Official Title
-----------------
A National Study for Blood Based Response Monitoring of Newly Diagnosed Aggressive B-cell Lymphoma (DLBCL and HGBCL) Patients

Conditions
-----------------
NHL

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with newly diagnosed DLBCL (including HGBCL- NOS and HGBCL-DH) according to WHO classification 2016 Ann Arbor stage II-IV Patients intended to be treated with 6 cycles R-CHOP (or DA-EPOCH-R) as first-line treatment (successive inclusion in HOVON 151 or HOVON 152 is possible) Age ≥ 18 years Exclusion Criteria: - Patients with limited stage I, II disease planned to receive 3 cycles of R-CHOP + radiotherapy, or 4 x R-CHOP+ 2R

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue material | For genomic analysis and clinical outcome data | 24 months |
Cerebral Oximetry and NIRS in Cardiac Arrest Patients

Study Overview
=================
Brief Summary
-----------------
This is an observational study to define the role and future applications of cerebral oximetry in cardiac arrest patients.

Official Title
-----------------
Cerebral Oximetry and NIRS in Cardiac Arrest Patients

Conditions
-----------------
Cardiac Death, Cardiac Arrest, Emergencies

Intervention / Treatment
-----------------
* Device: Cerebral Oximetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Non-traumatic cardiac arrest or post non-traumatic cardiac arrest No purposeful response to verbal or noxious stimuli Exclusion Criteria: Age < 18 years Open head injury/trauma

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 |
| --- | --- |
| CPR Group<br> | Device: Cerebral Oximetry<br>* Non invasive, near infrared spectroscopy cerebral oximetry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROSC | Return of spontaneous circulation | During ED resuscitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, cardiac death, CPR, neurologic prognostication, emergency medicine,
Time Interval for Changing Closed System Suction Catheters, Effect on Ventilator Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Detailed Description
-----------------
Comparison(s): the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Official Title
-----------------
Endotracheal Suction With or Without Daily Changes of Closed System Suction. Effect on Ventilator Associated Pneumonia and Cost

Conditions
-----------------
Pneumonia, Ventilator Associated, Closed System Suction Catheter

Intervention / Treatment
-----------------
* Device: Closed system suction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged greater than 18 years Mechanically ventilated for more than 24 hours Exclusion Criteria: Admitted from other hospital already mechanically ventilated Massive haemoptysis Previously received mechanical ventilation

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Closed system suction|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ventilator-associated pneumonia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital |  |  | 
| intensive care stay |  |  | 
| duration of mechanical ventilation |  |  | 
| hospital mortality |  |  | 
| number of acquired organ system derangements |  |  | 
| cost of the closed system suction catheters |  |  |