linjc16/ctgov huggingface dataset:
Safety and Efficacy of Bimatoprost Compared With Latanoprost in Patients With Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension

Conditions
-----------------
Ocular Hypertension, Glaucoma

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.03% eye drops
* Drug: latanoprost 0.005% eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular hypertension or chronic glaucoma Patient requires IOP-lowering therapy in both eyes Exclusion Criteria: Uncontrolled medical conditions Hypersensitivity to study medications

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>bimatoprost 0.03% eye drops | Drug: bimatoprost 0.03% eye drops<br>* Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks<br>* Other names: bimatoprost = Lumigan®;|
| Active Comparator: 2<br>latanoprost 0.005% eye drops | Drug: latanoprost 0.005% eye drops<br>* Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of latanoprost 0.005% 1 drop every evening for 12 weeks<br>* Other names: Xalatan®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. | Baseline, Week 12 | 
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 18 | Change from Baseline in mean diurnal IOP. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of both eyes at each time point measured at 8AM, 12PM and 4PM. For each eye, the IOP was either the average of the 2 measurements, or, if a third measurement was required, the median of the 3 measurements. A negative number change from Baseline indicated a reduction in IOP. | Baseline, Week 18 |
Observational Study on the Application of High-Flow Therapy After Percutaneous Transfemoral Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Percutaneous catheter-assisted valve replacement in aortic position (TAVI) for patients with high perioperative risk has become a standard method in recent years. In addition to the detection of bleeding and cardiac rhythm complications, follow-up care is mainly focused on the monitoring of respiratory parameters after an operation under intubation anesthesia or deep analgosedation. In addition to normal oxygen therapy, non-invasive ventilation and, in case of weaning failure, renewed tracheal intubation in the first 24 h after TAVI have been considered. High flow oxygen therapy (HFOT) now provides a good opportunity to treat patients with a warmed and humidified air-oxygen mixture and to independently control the oxygen content in the inhaled air and the flow in the pharyngeal area. The aim of the Study is to investigate the Change in oxygenation after high-flow oxygen therapy as a measure of weaning success in postinterventional patients after TAVI.

Official Title
-----------------
Observational Study on the Application of High-Flow Therapy in the Postinterventional Follow-up Care of Patients With Percutaneous Interventional Aortic Valve Replacement

Conditions
-----------------
Transcatheter Aortic Valve Replacement

Intervention / Treatment
-----------------
* Device: High-Flow Oxygen Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High-flow oxygen therapy after TAVI Exclusion Criteria: patients without consent age < 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 |
| --- |
|Device: High-Flow Oxygen Therapy|high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Horovitz index | The Gradient of paO2/FiO2 will be determined after TAVI via blood gas analysis | 24 hours |
IOP Reduction After Anecortave Acetate Injection in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
Introduction: Ocular administration of glucocorticoids is a common and effective treatment for several ocular diseases. However it is often complicated with the elevation of intraocular pressure (IOP). Anecortave acetate (AA) is an analog of cortisol acetate and lacks the typical anti-inflammatory and immunosuppressive properties of glucocorticoids. The effect of its anterior juxtascleral depot (AJD) injection has been evaluated in cases of glaucoma caused by intravitreal triamcinolone acetonide, presenting impressive results. The purpose of this study is to evaluate the efficacy and safety of the AA injection as a possible antiglaucoma treatment alternative. Methods: A prospective clinical study will be carried out including 30 glaucoma patients (30 eyes). After inclusion each patient will receive a single AJD injection of 30 mg of AA in the selected eye. Main outcome measure include: intraocular pressure at 1st day, 7th day, 1st, 2nd and 3rd months.

Official Title
-----------------
Anterior Juxtascleral Depot of Anecortave Acetate: Intraocular Pressure Reduction in Glaucoma Patients

Conditions
-----------------
Glaucoma, Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: Anterior Juxtascleral Depot of Anecortave Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced glaucoma cases with surgery or cyclophotocoagulation indication (IOP over 25 mmHg) Patients should be under maximum tolerated medication Low best corrected visual acuity (worse than 20/100) Exclusion Criteria: Under 18 or over 80

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: Anterior Juxtascleral Depot of Anecortave Acetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity; side effects (biomicroscopy exam) |  | Post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Anecortave Acetate, Intraocular pressure, Advanced glaucoma cases with uncontrolled IOP
Postspinal Hypotension and Cardiac Performance in the Elderly

Study Overview
=================
Brief Summary
-----------------
Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal anesthesia were analysed by logistic regression analyses.

Official Title
-----------------
Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study

Conditions
-----------------
ARTHROPLASTY, REPLACEMENT; ANESTHESIA

Intervention / Treatment
-----------------
* Other: Spinal anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hip or knee arthroplasty spinal anaesthesia age 65 years or more Exclusion Criteria: weight <40kg concomitant lithium medication written informed consent not obtained research team unavailable

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Spinal anaesthesia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume in ml | the blood volume pumped by the heart at each stroke | 0-45 minutes after spinal anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood pressure mmHg and change from baseline | mmHg measured by arterial catheter | 0-45 minutes after spinal anaesthesia |
Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

Study Overview
=================
Brief Summary
-----------------
A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.

Official Title
-----------------
Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

Conditions
-----------------
Epilepsy, Status Epilepticus

Intervention / Treatment
-----------------
* Device: Registration of EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unconsciousness due to seizures in the prehospital field Exclusion Criteria: Cardiac arrest Traumatic unconsciousness

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 |
| --- | --- |
| Mini-EEG, NCSE<br>Unconscious patients due to seizures, of whom EEG is registered | Device: Registration of EEG<br>* EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value of EEG | EEG signal assessed by a physician educated in interpretation of EEG, use a numeric scale (eg 0=not of value/corrupted, 5=good signal with diagnostic value) | 60min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency Care, Prehospital, Coma, Electroencephalography
Comparison of Two Anatomic Landmarks With Ultrasonography in Spinal Anesthesia

Study Overview
=================
Brief Summary
-----------------
The most used anatomical landmark for application of spinal anesthesia is Tuffier's line. Other alternative landmark is tenth rib. However there is no trial that compare these landmarks based on using ultrasonography.

Detailed Description
-----------------
The investigators aim to compare two landmarks (Tuffier's line and tenth rib line) for accuracy by using ultrasonography. 40 patients will be included in each groups. all of them will be assessed by ultrasonography during application of spinal anesthesia. And the investigators will examine the percentage of successful estimation of correct vertebral space.

Official Title
-----------------
Phase IV Study of Landmarks for Spinal Anesthesia

Conditions
-----------------
Arthropathy of Knee

Intervention / Treatment
-----------------
* Device: ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee arthroscopic surgery Exclusion Criteria: BMI>30 anatomical anomaly of vertebrae

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spinal anesthesia for knee arthroscopy<br>The intervention is spinal anesthesia. Tenth rib line or Tuffier's line will be examined as application landmarks by ultrasonography for spinal anesthesia. | Device: ultrasonography<br>* spinal anesthesia guided with ultrasonography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of estimation the correct vertebral space | Independently, first anesthesist will determine the spinal anesthesia application point (intervertebral space) according to Tuffier's line and second anesthesist will determine it by ultrasonography. And third anesthesist will compare the accuracy of first determination. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal anesthesia, ultrasonography, anatomical landmark
Effects of Oral Care in the Neuroscience ICU

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare how effective different ways of mouth cleaning are for patients in a neuroscience intensive care unit with a breathing tube in their mouth.

Detailed Description
-----------------
Patients with neurological dysfunction requiring intubation and ventilation are at risk for developing ventilator acquired pneumonia. Several studies have suggested that oral hygiene plays a role in the subsequent development of pneumonia for patients in the intensive care unit requiring intubation and mechanical ventilation.

Official Title
-----------------
Comprehensive Oral Care for the Intubated Neuroscience ICU Patient: A Comparison of the Safety and Efficacy Between 2 Protocols

Conditions
-----------------
Ventilator Associated Pneumonia, Oral Hygiene

Intervention / Treatment
-----------------
* Procedure: Standard Oral Care
* Procedure: Comprehensive Oral Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > or equal 18 years old Intubated within 24hours of admission to the Neuroscience ICU Intubation anticipated to continue for approximately 72 hours Exclusion Criteria: Minors Pregnancy Acute cervical spinal cord injury Severe facial trauma Family not present for consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Standard Oral Care | Procedure: Standard Oral Care<br>* Patients in this arm will receive standard oral care with manual brushes and routine oral hygiene products twice a day<br>|
| Experimental: B<br>Comprehensive Oral Care | Procedure: Comprehensive Oral Care<br>* Patients will receive a comprehensive oral care protocol using mechanical brushes and oral care products formulated for patients with a dry mouth twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Ventilator Acquired Pneumonia |  | During the period of intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Oral Health |  | During the period of intubation and 48 hours following extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilator Acquired Pneumonia, Oral Hygiene, Oral Care, Xerostomia
Plasma Vitamin and Homocysteine Levels and Thrombosis in Patients With Ph-negative MPNs

Study Overview
=================
Brief Summary
-----------------
Hyperhomocysteinemia is a risk for thrombosis. Thrombosis is more frequent in myeloproliferative neoplasms (MPNs) than the normal population. In this study, we investigated the thrombosis incidence, the effects of plasma homocysteine levels on thrombosis, and the correlations between folate, cobalamin, pyridoxine and homocysteine levels in MPNs, and to compare these results with the healthy controls.

Detailed Description
-----------------
Thirty-one new or formerly diagnosed MPN patients who consecutively visitted our outpatient clinic, as well as 40 age and sex matched healthy controls were enrolled in this study.

Official Title
-----------------
Plasma Cobalamin, Folate, Pyridoxine and Homocysteine Levels and Thrombosis in Patients With Philadelphia-chromosome-negative Myeloproliferative Neoplasms

Conditions
-----------------
Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult MPN patients and healthy controls who gave a written consent were included in the study. Exclusion Criteria: Exclusion criteria included not giving a written consent and using medications without an indication which may have an effect on plasma homocysteine and vitamin levels.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis |  | at least 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High Hcy level |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
the incidence of thrombosis,, the effect of Hcy on thrombosis formation,, the relation between Hcy and plasma vitamin levels,, to compare these results with the control group
MicroRNAs in Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Profiling of microRNAs and long noncoding RNAs (lncRNAs) in patients undergoing cardiac surgery. Analysis: Prediction of acute kidney injury by plasma expression profile of microRNAs?

Detailed Description
-----------------
In this pilot study we will include 150 patients undergoing cardiac surgery in a German university hospital. We will profile microRNA expression in plasma and urine before and at several timepoints after surgery. We will use a preselected panel of microRNAs and lncRNAs for analysis. Goal is to identify microRNAs/lncRNAs that are able to predict the occurence of AKI in these patients.

Official Title
-----------------
MicroRNAs in Acute Kidney Injury (MIRAKI) - a Pilotstudy -

Conditions
-----------------
Kidney Injury in Cardiac Surgery - Expression of microRNAs

Intervention / Treatment
-----------------
* Other: observation of microRNA expression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac surgery Exclusion Criteria: preexisting chronic kidney injury inclusion in another study pregnancy Kidney transplantation in history GFR < 30 ml/min (glomerular filtration rate) ECLS therapy (extracorporal life support)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observation of microRNA expression|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | AKI Stadium II or III following cardiac surgery. | 1 year |