linjc16/ctgov huggingface dataset:
A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.

Official Title
-----------------
A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE Study

Conditions
-----------------
Open Angle Glaucoma or Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DE-117 ophthalmic solution
* Drug: Timolol ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with open angle glaucoma or ocular hypertension Exclusion Criteria: Patients at risk of progression of visual field loss Patients with severe visual field defect Patients with any diseases that preclude participation in this study for safety reasons

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-117 ophthalmic solution (Group1)<br>Monotherapy | Drug: DE-117 ophthalmic solution<br> <br> |
| Experimental: DE-117 ophthalmic solution (Group2)<br>Monotherapy | Drug: DE-117 ophthalmic solution<br> <br> |
| Other: DE-117 ophthalmic solution + Timolol (Group3)<br>Concomitant Use | Drug: DE-117 ophthalmic solution<br> <br> Drug: Timolol ophthalmic solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of adverse events |  | Week 52 |
Color-dependent Melatonin Suppression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effects of complex, broad-band spectra light on the production of melatonin in humans.

Conditions
-----------------
Melatonin

Intervention / Treatment
-----------------
* Device: Light - standard
* Device: Light - alternate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable health Normal color vision Normal hearing 18-35 years old Exclusion Criteria: Significant depressive symptoms Pregnant or nursing Ocular pathologies Unstable or severe medical or psychiatric condition Extreme morning/evening type Regular smoker Use of medications that impact ocular function Alcohol use disorder Use of illegal drugs Irregular use of antihistamines, antidepressants, or sleeping medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light 1<br>Light 1 will have an altered color composition as compared with a standard LED bulb. | Device: Light - alternate<br>* Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with an altered spectral distribution (different color)<br>|
| Active Comparator: Light 2<br>Light 2 will be a standard LED bulb. | Device: Light - standard<br>* Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with standard spectral distribution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melatonin suppression | The amount of declination of salivary melatonin concentrations between the start of the light and the end of the light (4 hours later) will be compared between the conditions. | 4 Hours |
A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.

Official Title
-----------------
A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: CP-526,555 (varenicline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have smoked on average of at least ten cigarettes per day during the past year Subjects must have no period of abstinence greater than three months in the past year Exclusion Criteria: Subjects with any history of cardiovascular disease Myocardial infarction Significant arrhythmias Poorly controlled hypertension

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-526,555 (varenicline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fixed window 4-week CQR, Weeks 3-6, 4-7 |  |  | 
| Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52 |  |  | 
| 7-day Point Prevalence of abstinence Week 52 |  |  | 
| Number of cigarettes smoked per day |  |  | 
| Minnesota Nicotine Withdrawal Scale |  |  | 
| Smoking Effects Inventory |  |  | 
| Brief Questionnaire of Smoking Urge |  |  |
Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy

Study Overview
=================
Brief Summary
-----------------
One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure. The investigators intend to monitor the ambulatory blood pressure of such patients in order to assess whether this is a true haemodynamic effect.

Conditions
-----------------
Hypotension

Intervention / Treatment
-----------------
* Device: Ambulatory blood pressure monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-75 years Able to provide written, informed consent Taking rivaroxaban for any indication within the license of the drug, both once daily and twice daily dosing can be included Have measurable rivaroxaban levels on at least one occasion (this will be in line with standard of care, there will be no extra blood samples for the study) Not taking concomitant medication that can affect rivaroxaban metabolism (including amiodarone, dronedarone, -azole antifungals, protease inhibitors) On no antihypertensive or vasoactive medication Have a baseline BP recording taken in clinic Exclusion Criteria: Unable to provide written, informed consent Presence of concomitant medication that may alter rivaroxaban levels and confound results (see above) Unwilling to undergo ambulatory blood pressure monitoring Contraindication to ambulatory blood pressure monitoring

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

| Intervention/Treatment |
| --- |
|Device: Ambulatory blood pressure monitoring|Patients with dizziness on taking rivaroxaban will have ambulatory blood pressure monitoring to assess haemodynamic effects indirectly|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average blood pressure readings |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of blood pressure readings to rivaroxaban dosing |  | 48 hours | 
| Correlation of blood pressure readings to symptomatology |  | 48 hours |
Study of the Glycocalyx in Abdominal Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
The investigators want to measure the degradation of the endothelial glycocalyx before and after clamping the aorta, in patients operated for a abdominal aortic aneurism.

Detailed Description
-----------------
50 patients is scheduled for enrollment. Blood samples will be up taken before surgery, 10 min after reperfusion, at the end of surgery and the following morning. In addition the investigators are placing a renal venous catheter where blood samples will be up taken as mentioned above for the analysis of endothelial markers together with markers for kidney damage. The first 10 patient will act as part of a pilot study, where only measurement of the endothelial and renal failure markers will be performed.

Official Title
-----------------
Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.

Conditions
-----------------
Abdominal Aortic Aneurism, Surgery, Ischemic Reperfusion Injury

Intervention / Treatment
-----------------
* Other: Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 18 years Exclusion Criteria: prior engagement in scientific study within the last 30 days.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fresh frozen plasma<br>2 portions of FFP will be transfused prior to reperfusion | Other: Plasma<br>* 2 Units of plasma transfused equvilant to 2 times 275ml<br>* Other names: Fresh frozen plasma versus fresh non-frozen plasma;|
| Experimental: Fresh non-frozen plasma<br>2 portions of non-frozen plasma will be transfused prior to reperfusion | Other: Plasma<br>* 2 Units of plasma transfused equvilant to 2 times 275ml<br>* Other names: Fresh frozen plasma versus fresh non-frozen plasma;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial dysfunction | Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid balance | Perioperative and postoperative first 24 hours | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endothelia, Abdominal Aortic Aneurism, Glycocalyx, Reperfusion, Plasma
Assessing and Improving Balance Using Platform Perturbations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare current standing balance assessment methods to a new method that measures weight shift during small movements of a sliding platform. It will also be used to determine if balance improves with repeated exposure as part of a 4-week training program.

Official Title
-----------------
Assessing and Improving Balance Using Platform Perturbations

Conditions
-----------------
Balance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy no balance deficits age 20-35 or 50-65 Exclusion Criteria: moderate to severe arthritis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- |
| Young adult<br> | |
| Older adult<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in static sway |  | 20 days |
Ultrapure Water System for Hemodialysis Therapy

Study Overview
=================
Brief Summary
-----------------
We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure water) in comparison with the use of conventional water which are used in most dialysis units worldwide. To the best of our knowledge prospective data in that field is sparse.

Detailed Description
-----------------
In observational studies, the use of very pure dialysis solution has been suggested to reduce the plasma level of CRP, IL-6 ; to improve the response to anemia to erythropoietin therapy ; to promote better nutrition as evidenced by increase in plasma albumin value , estimated dry body weight, midarm muscle circumference and urea-nitrogen appearance rate; to reduce plasma level of β2-microglobulin and pentosidine ; to dely carpal tunnel syndrome ; to slow the loss of residual renal function; and to lower cardiovascular morbidity.The aim of this study is to prospectively evaluate the effect of dialysis performed with ultra-pure water (UPW)in comparison with dialysis with the use of conventional water system. Patients enrolled into this study will be evaluated at initial period of one month treated with conventional water system (-30 to 0 days). Then water system will be switched to ultra-pure water system with the use of filter added to the dialysis machine (Gambro). After switching to UPW system the patients will be followed for a period of one year (days 0-365). Primary end point will be change in CRP. Additional parameters: Blood pressure, adverse events during dialysis, hemoglobin levels and white-blood cell counts.

Official Title
-----------------
The Effect of Ultrapure Water System on Hemodialysis Therapy- a Single Center Trial

Conditions
-----------------
The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for, Hemodialysis., The Rate of Adverse Events Such as Hypotension During Hemodialysis Therapy With Ultra Pure Water, System as Compared to Conventional Water System.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic hemodialysis therapy thrice weekly > 3 months of therapy Signed an informed consent - Exclusion Criteria: Enrolled to other study Ongoing infection -

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 |
| --- | --- | --- |
| CRP |  | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 13 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrapure water,hemodialysis, CRP, blood pressure
Long-term Study of SYR-472

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.

Official Title
-----------------
An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: SYR-472


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is an outpatient. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Diabetes Mellitus Exclusion Criteria: The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYR-472 group<br>(long-term monotherapy or long-term combination therapy with anti-diabetic drugs) | Drug: SYR-472<br>* oral, for up to 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 52 weeks. |
Aortic Distensibility

Study Overview
=================
Brief Summary
-----------------
Can software be developed to automatically aid in the measurement of abdominal aortic aneurysms, and is there a way to predict future rupture or growth of abdominal aortic aneurysms.

Detailed Description
-----------------
Hypothesis: ECG-gated multidetector CT and ECG-gated Dual Source CT can be used to create multiple volumetric datasets of the abdominal aorta over the time period of the cardiac cycle, allowing for direct and regional calculations of abdominal aortic distensibility over the entire volume of the abdominal aorta, providing insight into risk of abdominal aortic aneurysm rupture and early large vessel stiffness.

Official Title
-----------------
ECG-Gated Multidetector CT of Aortic Distensibility FAMRI

Conditions
-----------------
Abdominal Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AAA must be at least 3 cm to a maximum 4.9cm cross-sectional diameter. BMI 31 or less. Creatinine results <2.0 and within six months prior to scan. US patients must have only normal creatinine (0.9 to 1.4) for one year before study visit. Patients who are originally scheduled for US, who are then subsequently rolled in this study, will have only a ultrasound scan as followup after the initial CTA. Exclusion Criteria: Creatinine > 2.0. Creatinine <0.9 or >1.4 for those who are scheduled for US. Atrial fibrillation or other arrythmia. Known AAA greater than 5 cm in size. Allergy to contrast dye.

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 |
| --- | --- |
| 1<br>Aortic aneurysm repair | |
| 2<br>Aortic aneurysm growth | |
| 3<br>Aortic aneurysm growth stable. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In year one, this data will be used to develop pulsatility software and test robustness. |  | First Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In year two, the time-resolved CT angiographic datasets from each patient will be analyzed to determine peak AAA pulsatility and peak AAA relative pulsatility (to cross-sectional area within the aneurysm). |  | Year Two | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal aortic aneurysm