linjc16/ctgov huggingface dataset:
Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pterygium vascularity and size before and after intralesional ranibizumab injection and to evaluate its recurrence rate following pterygium excision surgery.

Detailed Description
-----------------
The purpose of this study is to: Compare the vascularity of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection. Compare the size of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection. Compare the recurrence rate at 1 year after pterygium excision surgery between the group with and without intralesional ranibizumab injection.

Official Title
-----------------
Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study

Conditions
-----------------
Pterygium

Intervention / Treatment
-----------------
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with primary pterygium. Grade T3 (fleshy) pterygium. Exclusion Criteria: Patients with other ocular surface disorders. Previous ocular surgery or trauma. History of systemic thromboembolic event. Pregnant women and lactating mother.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>intralesional ranibizumab injected | Drug: ranibizumab<br>* Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.<br>* Other names: Lucentis;|
| No Intervention: control group<br>no intralesional ranibizumab injected. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pterygium recurrence | pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pterygium vessel area | Pterygium vesel area is defined as the as the ration of pixels occupied by the vessels within the pterygium area in percentage. | 1 week | 
| corneal pterygium area | Corneal pterygium area is defined as the as the ration of pixels occupied by the pterygium within the cornea area in percentage. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pterygium, ranibizumab, anti-VEGF, recurrence, vascularity, size
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (SAVR) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.

Official Title
-----------------
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

Conditions
-----------------
Aortic Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Any patient with severe, symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement. Severe AS: aortic valve area (AVA) ≤ 1.0 cm2 Symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to AS Exclusion Criteria: Emergent surgical aortic valve replacement. Inability to undergo TTE or TEE intra-operatively. Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| aortic annulus size | Show the correlation between the size of the aortic annulus measured intra-operatively with surgical rings (gold standard) with other methods of aortic annulus measurement that would not require surgical intervention (CT, TEE, TTE) | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Valve Replacement, AVR
Safety Study on a Wood-plastic Composite Cast

Study Overview
=================
Brief Summary
-----------------
An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.

Official Title
-----------------
A Wood-plastic Composite Cast - a New Ecological Splinting Method

Conditions
-----------------
Distal Radius Fracture

Intervention / Treatment
-----------------
* Device: Omnicast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: distal radius fracture not older than 14 days age 17-90 years mother tongue finnish or swedish Exclusion Criteria: open fracture other fractures or a previous fracture a previous or simultaneous tendon-, nerve- or vascular injury to the upper extremity a multiple injured hand decreased co-operation of the patient malignancy an illness affecting the general health
Sexes Eligible for Study
-----------------
All

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

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: splinting method<br>A new splinting method has been invented. This is a study using the splint / cast in treatment of distal radius fractures. | Device: Omnicast<br>* dorsal splint 2-5 weeks<br>* Other names: Omnicast by Onbone Finland;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How well will the material fulfil the demands of a splinting material | The aim of the study was to evaluate how well the material fulfils the demands of a splinting material, the subjective satisfaction of the treatment and the orthopaedic technicians´opinion of the material.The following parameters will be detected: immobilisation-time, conservative / operative treatment, re-reposition, mechanical properties of the cast, skin appearance or irritation caused by the cast, allergic reactions and subjective opinion. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cast, radius fracture
Bioequivalence of Eye Drops and Spray Administration of Vigamox

Study Overview
=================
Brief Summary
-----------------
The study compares the amounts of Vigamox absorbed when administered as eye drops or in a spray form. Both administrations will be prior to patients undergoing elective cataract surgery and the aqueous samples will be analyzed by a laboratory in a masked fashion. The hypothesis is that there will be no difference between the 2 modes of administration.

Official Title
-----------------
Laboratory-masked, Randomized Parallel, Comparative, Pilot Study on the Bioavailability of Vigamox in the Aqueous Humor When Administered Either as Commercially Available Eye Drops or in a Spray Form

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Vigamox - administration in spray form
* Drug: Vigamox eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective cataract surgery Exclusion Criteria: Allergy to Vigamox

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Vigamox delivered as spray | Drug: Vigamox - administration in spray form<br>* Vigamox will be administered in a spray form<br>|
| Active Comparator: B<br>Patients will receive the commercially available Vigamox drops | Drug: Vigamox eye drops<br>* Vigamox eye drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalency between the 2 ways of administration |  | 4 months |
Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype.

Detailed Description
-----------------
After informing the patient about the study and the potential risk. The patient is asked to wear a prototype of a novel device to sense oxygen levels and movement for the duration of the visit. The day of the enrolment is when the visit will be completed. The patient is required to complete an overnight sleep test (no more than 15 hrs) with the prototype device worn on their index finger and wrist.

Official Title
-----------------
A Single Center Study on the Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device

Conditions
-----------------
Hypoxic Events

Intervention / Treatment
-----------------
* Device: FDA approved pulse oximeter and DOVE device prototype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females 21 years of age or older Suspected to suffer from hypoxic events Able to provide informed consent Exclusion Criteria: Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Assess device prototype functionality<br>Everyone will be in the same arm | Device: FDA approved pulse oximeter and DOVE device prototype<br>* The objective is to assess reasonable detection of hypoxic episodes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing Dove device against FDA approved SpO2 sensor | Dove device will be analyzed against FDA approved SpO2 and Skin tone will be incorporated as a factor of SpO2 function to ensure the device can be reasonably detect hypoxia. | 15 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire about comfort of device | Participant will be surveyed for their subjective comfort wearing the DOVE prototype device. The questionnaire will ensure topics such as compliance and comfort or any issues and experiences the subject had with the prototype device. | 15-20 minutes depending on the patients questions. |
Activity and Health in Nursing Homes

Study Overview
=================
Brief Summary
-----------------
There is expected to be an increased need for full time nursing homes as the increase in number of older adults increases and the rate of dementia diagnosis happens simultaneous with the decrees of healthcare personnel the years to come. A lift in knowledge is needed to provide a better and more efficient healthcare to be better equipped to meet this societal challenge. Physical activity and sleep are important indicators of health, but also on effect of treatment and care for this frail population. Comprehensive mapping of personnel time spent on different tasks and older adults' physical function throughout a week gives a unique opportunity to gain new knowledge about everyday life in nursing homes. The main aim of this project is to describe associations between physical behavior, sleep and symptoms in residents in nursing homes in Trondheim Municipality and combine these with personnel time spent on different working tasks.

Official Title
-----------------
The Association Between Physical Behavior, Sleep and Neuropsychiatric Symptoms in Nursing Homes

Conditions
-----------------
Old Age, Frailty

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All residents in nursing homes in Trondheim Municipality. Exclusion Criteria: Terminal residents or residents that can not stand or walk a few steps independently.

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: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axivity accelerometer | Activity monitoring | 7 days | 
| Somnofy sleepmonitor | Sleep monitoring | 7 days | 
| Short Physical Performance Battery (SPPB) | Measurement of physical function | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time register | Time used on different tasks during the work day | 7 days | 
| Neuropsychiatric Inventory (NPI) | provide a brief assessment of neuropsychiatric symptomatology in routine clinical practice settings | Baseline | 
| Dementia Staging Instrument (CDR) | characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nursing home, Physical activity
Carotid Intima Media Thickness (CIMT) in Epistaxis

Study Overview
=================
Brief Summary
-----------------
Epistaxis is a very frequent emergency among adults and often needs specialised treatment in an ENT-department. Among others, atherosclerosis is often named as a reason for an increased risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined the carotid intima media thickness via ultrasound in patients who were treated in the ENT-department of the University Hospital of Zurich.

Official Title
-----------------
Carotid Intima Media Thickness in Patients With Epistaxis: a Surrogate Marker for Generalised Atherosclerosis

Conditions
-----------------
Epistaxis, Atherosclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active or very recently active anterior or posterior epistaxis at least 18 years old Exclusion Criteria: posttraumatic or postoperative epistaxis

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 |
| --- | --- |
| Epistaxis Group<br> | Diagnostic Test: Ultrasound<br> <br> |
| Control Group<br> | Diagnostic Test: Ultrasound<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid Intima Media Thickness in Epistaxis vs. Controls |  | June 2017 |
Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.

Official Title
-----------------
Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin to Reduce the Cholesterol Levels in Outpatients in a Realistic Environment. A Retrospective Study

Conditions
-----------------
Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dislipidemic population treated with rosuvastatin or ezetimibe/simvastatin for at least for 8 weeks Who have completed at least 80% of the treatment To have determinations at least of CT, TG C-LDL and CHDL before starting treatment and after 8 weeks of taking the medicine Exclusion Criteria: Initiating different therapy lipid lowering to Rosuvastatin or Ezetimibe/Simvastatin

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 |
| --- | --- |
| Dislipidemic Population<br>People with high levels of total cholesterol, LDL, C-HDL and triglycerides | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of the patients that achieve the goal proposed for NCEP ATP III (2001 y 2004) will be assessed, to C-LDL in patients treated with Rosuvastatin or Ezetimibe/Simvastatin at least for 8 weeks. |  | Data will be collected using CRFs after complete at least 15 patients over a 24 week period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of LDL-C reduction according to baseline levels in patients treated wuth Rosuvastatin or Ezetimibe/Simvastatin for at least 8 weeks. |  | Data will be collected using CRFs after complete at least 15 patients over a 24 week period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolemia, Statins
Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD)

Study Overview
=================
Brief Summary
-----------------
INTRODUCTION: Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by increasing the production of H2O2, the administration of SOD can trigger endogenous/internal antioxidant mechanisms. Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this study was to evaluate the protective effect of SOD on the bilateralization of the disease.

Official Title
-----------------
SOD as Antioxidant Treatment OF ARMD

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Dietary Supplement: SOD
* Dietary Supplement: Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral neo-vascular ARMD Exclusion Criteria: other pathology
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br> | Dietary Supplement: Sham<br> <br> |
| Experimental: SOD<br> | Dietary Supplement: SOD<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference on AREDS score, Month 24 - Month 0 |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARMD, SOD
The Effect of Methylphenidate on Motor Learning in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether methylphenidate facilitates so called short-term plasticity as measures with transcranial magnetic stimulation, in patients with stroke.

Detailed Description
-----------------
Stroke patients are to be examined with transcranial magnetic stimulation (TMS) before and after a short training session. TMS will be used to demonstrate changes in cortical excitability (motor threshold) and intracortical inhibition and facilitation. The effect of methylphenidate on baseline TMS measures will be evaluated as well as the effect on training induced changes in TMS measures (by comparing baseline and posttraining measures). The patients will be trained on two separate occasions, to compare the effect of Methylphenidate to placebo.

Official Title
-----------------
Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than two months after first stroke. Moderate to light hand paralysis Measurable MEP in the abductor pollicis brevis muscle Able to read and understand the written information Signed informed consent Exclusion Criteria: Epilepsy Glaucoma Hyperthyroidism Cardiac arrythmia Known heart disease or angina. Metal implants Pacemaker Pregnancy Diastolic BP>100 mmHg In treatment with MAO-inhibitor, SSRIs og Ritalin

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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training induced changes in Short interval Intracortical Inhibition (SICI). |  |  | 
| Training induced changes in Intracortical facilitation (ICF) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo |  |  |