linjc16/ctgov huggingface dataset:
Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.

Study Overview
=================
Brief Summary
-----------------
Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.

Detailed Description
-----------------
To study the potential benefits of intraoperative methylene blue use in pilonidal sinus surgery in detecting the borders of the disease, the histopathologic correlation between the specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene blue was investigated. The branches that distinctly exceeded the planned dyed excision borders will tried to be detected histopathologically, if any.

Official Title
-----------------
Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: Pilonidal sinus excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pilonidal sinus disease of the intergluteal region Primary disease without history of drainage Ages between 18 and 65, both gender Exclusion Criteria: Recurrent pilonidal sinus disease Acute infection with abscess formation and/or purulent copious drainage Denial to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: Methylene Blue<br>The effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically. | Procedure: Pilonidal sinus excision<br>* The dyed portion of the excised pilonidal sinus and non-dyed cavity excision specimen will be studied histopathologically to detect any remnant of pilonidal sinus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pilonidal sinus, Methylene blue, Histopathology, Surgery
Mental Stress, Autonomic Function, and Heart Disease

Study Overview
=================
Brief Summary
-----------------
To examine the vagal, vascular sympathetic, and mechno-structural components of baroreflex regulation in coronary artery disease (CAD) patients and healthy age-matched controls during rest and acute laboratory stress.

Detailed Description
-----------------
BACKGROUND: The strong association between mental stress and morbid cardiovascular events in coronary artery disease (CAD) patients may derive from stress-induced cardiac ischemia due to exaggerated increases in vascular resistance and arterial pressure. In fact, this may explain part of the prognostic relationship of baroreflex cardiac vagal control to cardiovascular outcome among CAD patients. The hemodynamic responses to psychological stress are buffered by the arterial baroreflex; thus, exaggerated pressor responses to mental stress may result from impaired baroreflex regulation in CAD patients. DESIGN NARRATIVE: The study has three components. The first component characterizes the relationships between vascular stiffness and baroreflex regulation among CAD patients, also contrasting healthy control subjects with CAD patients. The second component examines, in relation to individual differences in pharmacologically derived estimates of baroreflex function, changes in autonomic and baroreflex control during laboratory psychological stress among CAD patients and among healthy control subjects. The third component tests the hypothesis that impaired baroreflex regulation in CAD patients, due to increased vascular stiffness and/or attenuated autonomic control, is associated with exacerbated hemodynamic reactions to psychological stress. Bolus vasoactive drug infusions in combination with Finapres beat-by-beat arterial pressures and carotid B-mode ultrasonography are used to evaluate baroreflex sensitivity and arterial stiffness. Baroreflex adjustments to psychological stress are assessed by power spectral-derived relations between arterial pressure and cardiac chronotropy during a mental arithmetic task and a speech task. The degree to which indices of baroreflex function are associated with hemodynamic responses to psychological stress among CAD patients is assessed.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.

Official Title
-----------------
Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination

Conditions
-----------------
Diagnostic Imaging

Intervention / Treatment
-----------------
* Drug: Ultravist (Iopromide, BAY86-4877)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist. Exclusion Criteria: No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Ultravist (Iopromide, BAY86-4877)<br>* Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | During and after Ultravist application on the day of examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General contrast quality in the region of interest as assessed by physicians |  | On the day of examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug utilization review
Autonomic Nervous System Activity and Oculocardiac Reflex.

Study Overview
=================
Brief Summary
-----------------
Pulling the eyeball during ophthalmic surgery provokes decrease in heart rate. This phenomenon is called oculocardiac reflex. In some patients asystole may occur. Other cardiac features of this reflex include hypotension, dysrhythmias, atrioventricular block. These cardiovascular disturbances may lead to decreased perfusion and ischemia of vital organs. Patients with existing cardiovascular disease are in risk of complications. Cardiovascular system is mainly innervated with autonomic nervous system (ANS). Sympathetic/parasympathetic activity may be determined by Heart Rate Variability (HRV). HRV analysis based on short 5 minutes electrocardiography has been found useful for prediction of hypotension and bradycardia during induction of general anaesthesia and during spinal block. The aim of this study is to verify whether it is possible to predict oculocardiac reflex with the use of HRV analysis for ANS activity assessment, measured prior to the ophthalmic surgery.

Official Title
-----------------
Prediction of Oculocardiac Reflex in Relationship to Autonomic Nervous System Activity, Mesured With the Use of ECG HRV Analysis.

Conditions
-----------------
Bradycardia During Pulling of Eyeball

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned surgery over 18 years of age surgery under general anaesthesia Exclusion Criteria: urgent surgery under 18 years of age and over 65 patients with generalised, nontreated disease patients receiving beta blockers or calcium channel blocker diabetic patients patients operated under peri or retrobulbar anaesthesia

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oculocardiac reflex occurence in relation to autonomic system activity |  | perioperatively - about 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oculocardiac effect, bradycardia, HRV
Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment

Study Overview
=================
Brief Summary
-----------------
Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay & reduce flares

Official Title
-----------------
Clinical Study on Tacrolimus Ointment Over the Long-term. CONTROL Study - Adults

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: tacrolimus ointment
* Drug: Placebo ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient of any ethnic group Patient was at least 16 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3) Exclusion Criteria: Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma Patient had a clinically significant skin infection on the affected (and to be treated) area

Ages Eligible for Study
-----------------
Minimum Age: 16 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: 1<br> | Drug: tacrolimus ointment<br>* Topical application<br>* Other names: Protopic®;|
| Placebo Comparator: 2<br> | Drug: Placebo ointment<br>* Topical application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbations of atopic dermatitis requiring intervention. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dermatitis, atopic, Tacrolimus, Adult, treatment outcomes
C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.

Detailed Description
-----------------
see below

Official Title
-----------------
C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks

Conditions
-----------------
Hereditary Angioedema

Intervention / Treatment
-----------------
* Drug: rhC1INH or pdC1INH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decision to treat the HAE patient with C1 inhibitor (either Ruconest or pdC1INH) Patients must give written informed consent Exclusion Criteria: A diagnosis of acquired C1INH deficiency (AAE)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hereditary Angioedema<br> | Drug: rhC1INH or pdC1INH<br>* C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)<br>* Other names: Ruconest;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INH of acute angioedema attacks |  | December 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies) |  | December 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hereditary Angioedema, HAE, Angioedema, Recombinant C1 Inhibitor, rhC1INH, registry
Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

Study Overview
=================
Brief Summary
-----------------
The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis and assessment of the severity of heart failure in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and NT-proBNP assays for both whole blood and plasma in the intended use population.

Official Title
-----------------
Clinical Sensitivity and Specificity Study of AQT90 FLEX BNP and NT-proBNP

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 21 years of age or older Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study Subject has diagnosis of heart failure Exclusion Criteria: Subject has Acute Coronary Syndrome (ACS) Subject has been diagnosed and/or treated for malignancy within past 6 months Subject has had cardiac surgery within the past 4 weeks Subject claim of pregnancy Subject's prior participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Heart Failure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the clinical sensitivity and specificity of the AQT90 FLEX BNP and NT-proBNP assays at the clinical cut-off in heart failure patients | Clinical sensitivity and specificity with 95 % confidence intervals of the AQT90 FLEX BNP and NT-proBNP assays will be determined at the clinical cut-off in heart failure patients divided by age, gender and New York Heart Association (NYHA) functional classification. | Single blood draw upon study entry |
Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4

Study Overview
=================
Brief Summary
-----------------
This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days. Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions.

Official Title
-----------------
An Open Label Balanced Study in Healthy Subjects to Evaluate the Potential for Cytochrome P 450 3A4 Induction by Oral OC000459 Using Oral Midazolam as a Probe

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: OC000459


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Judged to be in good health at screening (blood tests, physical examination, medical history) Exclusion Criteria: Evidence of a clinically significant underlying medical condition that in the opinion of the Investigator would represent a risk to study participation.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OC000459<br> | Drug: OC000459<br>* OC000459 100mg tablet, twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of exposure of midazolam and 4-hydroxymidazolam (without/with exposure to OC000459) as measured by plasma AUC0-t and Cmax for midazolam and its active metabolite 4-hydroxymidazolam. |  | 6.5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam |  | 6.5 days | 
| Safety and tolerability of OC000459 |  | 6.5 days |
Compare Effectiveness of Eplerenone vs Atenolol in Reversing the Remodelling Resistance Arteries in Subjects With HT

Study Overview
=================
Brief Summary
-----------------
To investigate the impact of antihypertensive therapy with the selective mineralocorticoid receptor blocker, eplerenone, on small resistance artery remodeling, compared to the effect of equivalent blood pressure control achieved with a b-blocker, atenolol.

Official Title
-----------------
A Double-Blind, Parallel Design Study to Compare the Effectiveness of Eplerenone Versus Atenolol in Reversing the Remodeling of Resistance Arteries in Subjects With Mild to Moderate Primary Hypertension

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

Intervention / Treatment
-----------------
* Drug: Eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pt with essential hypertension who have never been treated or untreated within the previous 6 months Exclusion Criteria: History of Malignant Hypertension Sitting diastolic blood pressure > 115mmHg or sitting Systolic blood pressure > 200mmHg

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to week 52 in the media/lumen ratio and the maximum % relaxation response to acetylcholine of gluteal subcutaneous resistance vessels, measured from the gluteal biopsy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Will be done for both the Intent to Treat and per protocol populations, and use both the LOCF and OC methods |  |  |