linjc16/ctgov huggingface dataset:
Anal Fistula and Microdialysis - What is Yet to Learn?

Study Overview
=================
Brief Summary
-----------------
Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed.

Detailed Description
-----------------
Patients with anal fistula can have a reduced quality of life for years do to fistula complications. This condition is not well researched and more knowledge is needed to provide better care. Microdialysis has been used to study other organs of the body such as the brain, liver and GI-tract. Upcoming study is going to study the inner environment of the anal fistula in regards to lactate, pyruvate and glucose. The study group is patients with anal fistula that with a need for seton treatment. Measurements with microdialysis will take place before operative procedure and one month after getting their seton inserted.

Official Title
-----------------
Intervention With Microdialysis Measurements in Anal Fistula

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Device: OnZurf Probe, Senzime AB, Uppsala, Sweden


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age to be able to understand and accept the terms of study Exclusion Criteria: age under 18 dementia, language barrier

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: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Microdialysis is used to investigate the inner enviorment of anal fistulas. The patient will be its own control with measurements at prior to intervention and after operative procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate. | Device: OnZurf Probe, Senzime AB, Uppsala, Sweden<br>* Probe is inserted into the fistula and measurements are made of the inner environment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurements of glucose in anal fistula using microdialysis | measurements of glucose in fistula using microdialysis, change in value is being assessed | baseline measurement, 1 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of pyruvate in anal fistula using microdialysis | measurement of pyruvate measurements in fistula using microdialysis, change in value is being assessed | baseline measurement, 1 month follow up |
Study of T900607-Sodium in Previously Treated Patients With Ovarian Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether T900607-sodium is effective and safe in treating ovarian cancer.

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Drug: intravenous T900607-sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Histologically or cytologically confirmed diagnosis of ovarian cancer Subjects must have received 1-2 regimens of prior chemotherapy (with one containing paclitaxel) At least 18 years of age Bidimensionally measurable disease amenable to CT scanning. At least one lesion must be least 1 X 1 cm in size. Karnofsky performance status of at least 70% Estimated life expectancy of at least 12 weeks Females of childbearing potential must have a negative pregnancy test and agree to use an effective contraceptive Subject must be able to comply with study procedures and follow-up examinations. Signed written informed consent Lab Values (obtained ≤ 7 days prior to study enrollment): ANC at least 1.5x10e9/L, Platelet count at least 100x10e9/L, Hemoglobin at least 8.5 g/dL, Creatinine within 2 times upper limit of normal AST and ALT within 3 times upper limit of normal Bilirubin within 1.5 times upper limit of normal Albumin great than 2.5 g/dL INR < 1.5 for subjects without anticoagulants Exclusion Criteria Severe, concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the subject inappropriate for enrollment NYHA Class III/IV cardiac disease, left ventricular ejection fraction (LVEF) of <50%, or acute anginal symptoms Patients who have received any investigational agent within 4 weeks of enrollment Patients who are pregnant or breast-feeding History of prior malignancy other than ovarian cancer within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix History of central nervous system metastases or carcinomatous meningitis Major surgery within 4 weeks of enrollment

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

Sexes Eligible for Study
-----------------
Female

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: intravenous T900607-sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

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

Intervention / Treatment
-----------------
* Drug: bromfenac ophthalmic solution
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for cataract surgery Exclusion Criteria: Known hypersensitivity to bromfenac and salicylates

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 |
| --- | --- |
| Experimental: Bromfenac<br>Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily | Drug: bromfenac ophthalmic solution<br>* sterile ophthalmic solution<br>|
| Placebo Comparator: Placebo<br>Placebo, Dosed 1 Drop Daily | Drug: placebo<br>* sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Are Pain Free | Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract extraction with intraocular lens implantation
Ureteral Stent Length and Patient Symptoms

Study Overview
=================
Brief Summary
-----------------
The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock wave treatment for kidney stones.

Detailed Description
-----------------
Patients undergoing electro shock wave for treatment of kidney stones are randomized to long or short stent length after signing an informed consent prior to their surgery. They keep a pain diary and medication diary for a two week period after the stent is placed. These are turned in at the two week post-op visit. Patients also complete a quality of life and urinary symptom score questionnaire pre and post operatively.

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Device: Ureteral Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones - Exclusion Criteria:Under 18 years of age, inability to give informed 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ureteral Stent|Ureteral stents are not investigatory but rather part of standard of care. In this study, we were interested in having patients fill out pre and post-operative questionnaires so that we could compare their symptoms with the length of their ureter and the stent placed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
High Dose BAYA1040_Nifedipine: a Dose-comparative Study

Study Overview
=================
Brief Summary
-----------------
This is a clinical study evaluating the superiority in efficacy and assess safety and tolerability of BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) compared with BAYA1040_Nifedipine 40 mg/day (40 mg once daily) in patients with essential hypertension who are not at target blood pressure by BAYA1040_Nifedipine 40 mg once daily treatment.

Official Title
-----------------
A Multicenter, Double-blind, Parallel-group Comparative Study Between Oral BAYA1040_CR 80 mg and 40 mg for 8 Weeks in Patients With Essential Hypertension for Whom Oral BAYA1040_CR 40 mg is Insufficient

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Nifedipine (Adalat, BAYA1040)
* Drug: Nifedipine (Adalat, BAYA1040)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years or older Japanese male or female Outpatient with essential hypertension Patients whose sitting diastolic blood pressure (DBP) is 90 mmHg or more despite more than 4 weeks of treatment with antihypertensive drug Exclusion Criteria: Sitting diastolic blood pressure (DBP) is 110 mmHg or more or sitting systolic blood pressure (SBP) is 180 mmHg or more Patients with secondary hypertension or hypertensive emergency

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1<br> | Drug: Nifedipine (Adalat, BAYA1040)<br>* BAYA1040_Nifedipine 40mg twice daily (BID)<br>|
| Active Comparator: Arm 2<br> | Drug: Nifedipine (Adalat, BAYA1040)<br>* BAYA1040_Nifedipine 40mg once daily (OD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy changes measured by sitting diastolic blood pressure (DBP) |  | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy changes measured by sitting systolic blood pressure (SBP) |  | Up to 8 weeks | 
| Achievement rate: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines |  | Up to 8 weeks | 
| Responder rate: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a &gt;10 mmHg reduction of DBP |  | Up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BAYA1040_Nifedipine, Nifedipine, Essential hypertension, Japanese Patients, Phase III, 13176
Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Study Overview
=================
Brief Summary
-----------------
The present protocol will utilize simultaneous recording of brain activity during attention and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo administration. The investigators hypothesize that amplitudes of associated with memory will be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity associated with stimulus processing as evidenced by abnormal reduction in the amplitude of specific brain regions relative to placebo.

Detailed Description
-----------------
The proposed research has two specific aims: 1) demonstrate that ramelteon has no effect on event related potential components that reflect basic sensory processes (P1 and N1), and will not impair attention and memory processes, whereas the benzodiazepine receptor agonist zolpidem will significantly reduce (relative to placebo) the amplitude of these event related potential components throughout the cerebral cortex and 2) show that ramelteon reduces the abnormal hyperarousal in insomnia as reflected through a reduction in the contingent negative variation component of the event related potential across frontal and parietal brain regions.

Official Title
-----------------
Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Conditions
-----------------
Insomnia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals with no secondary condition to insomnia. Exclusion Criteria: Healthy individuals with no insomnia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| 1<br>Insomniacs: Individuals reporting difficulty falling asleep or staying asleep within the past month for more than 3 days per week. Individuals much also meet screening criteria based on an overnight polysomnograph of latency to persistent sleep >20 minutes and/or >60 minutes of wake after sleep onset. | |
| 2<br>Controls: Individuals reporting no difficulty falling asleep or staying asleep and objective sleep measures based on an overnight polysomnograph of latency to persistent sleep <20 minutes and/or <60 minutes of wake after sleep onset. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Correlation of Heart Hemodynamic Status Between 320 Multidetector Computed Tomography, Echocardiography and Cardiac Catheterization in Patients With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
With the advances in multidetector computed tomography (MDCT) technology, CT angiography (CTA) of the coronary arteries using 64-slice or dual-source CT systems has evolved into a robust, alternative, noninvasive imaging technique to rule out coronary artery disease (CAD). Reported sensitivities and specificities of coronary CTA can compete with those of catheter angiography. Because CT is the major source of ionizing radiation in medicine, dual isotope myocardial perfusion scintigraphy and coronary CTA 16-, 64-slice MDCT and DSCT scanners are associated with the highest amount of radiation dose. Recently, a new generation of MDCT machines with even more detector row (320) has become clinically available. The maximum detector width of 16 cm enables the entire heart to be examined in a single rotation and within a single heartbeat and is expected to substantially reduce artifacts from breathing and body motion. Due to high volume coverage, 320-slice CT machines are able to perform a nonspiral, ECG-gated examination of the heart within a single breath-hold. The purpose of this study was to investigate the correlation of hemodynamic status of 320 MDCT, echocardiography, and coronary catheterization in patients who suspected coronary artery disease.

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intermediate or high risk for coronary artery disease Healthy volunteers Exclusion Criteria: Unstable angina Acute myocardial infarction Active cancer status Renal failure(Creatinine > 1.5 mg/dl) Contrast allergy history Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| percentage of stenosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD
Low Dose Vasopressin in Traumatic Shock

Study Overview
=================
Brief Summary
-----------------
Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.

Official Title
-----------------
Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation

Conditions
-----------------
Injuries, Shock, Traumatic

Intervention / Treatment
-----------------
* Drug: normal saline control
* Drug: vasopressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment: Patient is a male or female patient presumed to be at least 18 years of age; Patient has a systolic blood pressure < 90 mmHg; Patient has clinical evidence of acute traumatic injury; Infusion of study drug must start within one hour following SBP (systolic blood pressure) < 90 mmHg Exclusion Criteria: A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment: Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury; Patient has received greater than 4 liters fluid since time of injury; Patient is enrolled in another shock trial; Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization; Female patient is pregnant by report or suspicion; Patient has known Do Not Resuscitate orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);

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 |
| --- | --- |
| Experimental: I<br>Vasopressin | Drug: vasopressin<br>* vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours<br>|
| Placebo Comparator: 2<br>bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added | Drug: normal saline control<br>* no vasopressin added to bolus or 5 hour continuous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Endpoint of This Study Will be Day 30 Mortality. | Survival of a traumatic injury subject to at least 30 days after admission to the emergency room. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Vasopressin After Trauma. | Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm | 12 hours |
Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Pain Resulting From Thermal Injury

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of REGN475 in patients with pain due to thermal injury.

Conditions
-----------------
Thermal Injury Pain

Intervention / Treatment
-----------------
* Drug: R475
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury Moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days Exclusion Criteria: Patients with burns caused by chemical exposure or electricity Patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection Patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries Significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments. Women who are pregnant or nursing

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br>R475 | Drug: R475<br>* IV<br>|
| Experimental: Dose 2<br>R475 | Drug: R475<br>* IV<br>|
| Placebo Comparator: Dose 3<br>Placebo to match R475 dose | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in procedural pain intensity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative analgesic usage |  |  | 
| Weekly Patient-rated Global Impression of Change |  |  | 
| Additional quality of life assessments |  |  |