linjc16/ctgov huggingface dataset:
The Effect of Intravenous Lidocaine on Trigeminal Neuralgia

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized double blind, placebo controlled, crossover study is to investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia. Included patients will undergo four weekly sessions, two of which with lidocaine (5mgs/kg) and two with placebo infusions administered over 60 minutes. Effect will be measured with pain diaries and visual analogue scales.

Conditions
-----------------
Trigeminal Neuralgia

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) confirmed diagnosis of TN according to IASP definition, (2) age equal to or greater than 18 years, (3) visual analogue scale (VAS) score equal to or greater than 3 (out of a maximum 10), (4) DN4 score equal to or greater than 4 (out of a maximum 10), (5) having received the recommended medications for TN (antiepileptics, spasmolytics, opioids, anti-inflammatory and simple analgesic drugs) for an adequate period without therapeutic results, (6) TN duration of at least 12 months, (8) no history of allergy to lidocaine, (9) no history of substance abuse, (10) absence of severe psychiatric diseases, (11) not being pregnant, (12) not lactating, (13) absence of severe cardiac, hepatic and renal decease, and (14) be willing to provide a written informed consent to undergo the experimental procedures.

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lidocaine<br> | Drug: Lidocaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Effect, Lidocaine
The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates

Study Overview
=================
Brief Summary
-----------------
This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid
* Procedure: Acute Normovolemic Hemodilution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB). Exclusion Criteria: Jehovah's witness patients.

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Normovolemic Hemodilution<br>Patients that receive acute normovolemic hemodilution prior to surgery. | Procedure: Acute Normovolemic Hemodilution<br>* Draw 20 mL/kg (up to 5Kg) of blood from patient and replace with washed PRBCs at 10-20mL/kg. (If > 5Kg draw 20% of circulating blood volume without PRBC replacement)<br>|
| Tranexamic Acid<br>Patients that receive tranexamic acid during surgery. | Drug: Tranexamic Acid<br>* 100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of postoperative hemostasis | Evaluating the body's ability to stop or decrease postoperative bleeding. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of blood transfusions | Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op. | 24 hours |
Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds. Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.

Detailed Description
-----------------
Until now no expected or unexpected adverse events were occurred

Conditions
-----------------
Venous Insufficiency, Diabetes

Intervention / Treatment
-----------------
* Device: DermaStream(tm) application and Streaming of Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic ulcer, OR Venous insufficiency ulcer Age range: 18-80 years Wound max. diameter range: 1.5 - 10 centimeters Wound San Antonio assessment system: grade 1 and 2, stage A and B Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries Ankle-Brachial Index > 0.7 by Doppler Wound present for at least 6 weeks Wound location: foot or calf, at a location where the device can be attached properly Lack of purulent discharge from the wound. Exclusion Criteria: Hypoalbuminemia: Albumin < 2gr/dl Right-side congestive heart failure with edema of legs: +2 or higher Renal insufficiency: Cr > 2 mg/dl Abnormal liver function: ALT or AST>300 Skin disorders adjacent to the wound, unrelated to the pathology of the wound Non-cooperative patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DermaStream(tm) application and Streaming of Saline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis

Study Overview
=================
Brief Summary
-----------------
Juvenile idiopathic arthritis (JIA) is one of the most common rheumatic diseases in childhood, affecting at least 1 in 1000 children. Children with JIA experience joint inflammation and swelling, pain and tenderness, morning stiffness, limited mobility. Children with JIA complain pain and have lower functional ability and decreased quality of life compared with their peers. Many studies have reported that patients with JIA have low physical activity levels and also exercise therapy is considered an important component of the treatment of JIA. Nowadays, studies for evaluating exercise behaviours in order to cope with physical inactivity for many chronic diseases are becoming increasingly important.The objective of this study is to determine exercise behaviour in patients with JIA.

Official Title
-----------------
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis

Conditions
-----------------
Juvenile Idiopathic Arthritis

Intervention / Treatment
-----------------
* Diagnostic Test: Assessing exercise behavior


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as JIA according to ILAR classification Aged between 6-18 Adequate cognitive function for understanding questions Exclusion Criteria: - a parent who does not have a smartphone

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assessing exercise behavior<br>determining exercise behaviour in patients with JIA by using specific scales | Diagnostic Test: Assessing exercise behavior<br>* 11-point Numeric Analogue Scale (NRS) for satisfaction of exercising, Exercise Stages of Change Scale-Short Form (ESCS), Exercise Self-Efficacy Scale (ESES), and Decisional Balance Scale (DBS) for exercise behaviour will be inquired for the patients with JIA.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-point Numeric Analogue Scale |  | baseline | 
| Exercise Stages of Change Scale-Short Form |  | baseline | 
| Exercise Self-Efficacy Scale |  | baseline | 
| Decisional Balance Scale |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Juvenile Idiopathic Arthritis, exercise, behavior
The Effects of Dietary Factors on Physiological Subjective Stress Responses

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the role of dietary factors in chronically stressed subjects. Previous studies have shown that milk proteins, B vitamins and probiotics may influence on subjective well-being in stressed subjects.

Official Title
-----------------
The Effects of Dietary Factors on Physiological Subjective Stress Responses in Cronically Stressed Subjects: a Randomised Clinical Trial

Conditions
-----------------
Chronic Stress

Intervention / Treatment
-----------------
* Dietary Supplement: Yogurt-like snacks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STAI points 40-65 BMI 18-30 kg/m2 healthy Exclusion Criteria: Gastrointestinal disease, diabetes or any other significant major medical morbidity milk allergy smoking excess use of alcohol pregnancy and breast feeding waist circumference males >102 cm, females >88 cm no medication or dietary supplements influencing measured responses

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study product containing milk proteins<br>Yoghurt-like milk-based product | Dietary Supplement: Yogurt-like snacks<br>* twice a day 120 g for four weeks<br>|
| Active Comparator: Study product containing probiotics<br>Yoghurt-like milk-based product | Dietary Supplement: Yogurt-like snacks<br>* twice a day 120 g for four weeks<br>|
| Placebo Comparator: Control product<br>Yoghurt-like milk-based product without supplemented nutrients | Dietary Supplement: Yogurt-like snacks<br>* twice a day 120 g for four weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective well-being | Change in stress and mood states measured by State-trait anxiety inventory (STAI) and modified Profile of Mood States (POMS) at baseline and after 4 wk intervention | baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological measurements | Change in salivary cortisol, blood pressure, heart beat variability, sleep and inflammatory markers. | baseline and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, milk protein, probiotics, cortisol, heart beat
Assessment of Coronary Artery Disease in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography.

Detailed Description
-----------------
Stroke and coronary artery disease (CAD) share common risk factors and pathological mechanisms. CAD is an important cause of death in patients with stroke. Currently, coronary CT angiography (CCTA) is very useful non-invasive tool for detection of CAD and plaque analysis. Therefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of CAD in stroke patients through follow-up (more than 5 years) using CCTA.

Official Title
-----------------
Prevalence and Characteristics of Coronary Atherosclerosis in Stroke Patients Using Coronary CT Angiography

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute stroke patients who diagnosed by clinical and brain MR imaging Who performed coronary CT angiography within 3 months after acute stroke Exclusion Criteria: intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage brain tumor Previous myocardial infarction Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery Insufficient medical record Poor image quality of CCTA scan

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Coronary artery disease, Stroke<br>Coronary artery disease, stroke, coronary CT angiography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (Major Adverse Cardiac Event) | MACE was included as follows: 1) all-cause mortality, 2) myocardial infarction, 3) unstable angina requiring hospitalization | Participants will be followed until June. 2015, an expeded average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any cardiac events | 1) late revascularization: who underwent revascularization therapy mroe than 90days after CCTA and referral due ot new symptoms or an abnormal function test, 2) heart failure required hospitalization. | Participants will be followed until June. 2015, an expeded average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, stroke, coronary CT angiography
The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke.

Detailed Description
-----------------
This study has two types of interventions. The clinics and patients are randomly assigned to either a control or intervention group. All clinics have both control and intervention patients. In the clinic intervention, we help doctors monitor patient information about the risk factors of heart disease and stroke. In the patient intervention, we contact patients by phone to discuss these risk factors before their doctor visits.

Official Title
-----------------
Diabetes and Cardiovascular Risks in Primary Care

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: Patient Activation and Diabetes Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be diagnosed with diabetes for at least 12 months. Patient must be with current physician for at least 12 months. Study staff must be able to reach patient by telephone. Exclusion Criteria: Pregnant women are excluded.

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Patient Activation and Diabetes Registry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure |  |  | 
| Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors |  |  | 
| Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication |  |  | 
| Assessment of Chronic Illness Care (ACIC) Surveys |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patient activation, primary care, diabetes, cardiovascular risk
Clinical Intervention Psychosis and Addiction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate an integrative therapeutic concept for schizophrenic patients with comorbid substance use disorder.

Official Title
-----------------
Evaluation of an Integrative Therapeutic Concept for Schizophrenic Patients With Comorbid Substance Use Disorder

Conditions
-----------------
Psychosis, Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Skills trainig for patients with dual diagnosis
* Behavioral: regular treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia Addiction Written statement of agreement Majority Exclusion Criteria: Acute psychosis Further neuropsychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Treatment<br> | Behavioral: Skills trainig for patients with dual diagnosis<br>* Skills trainig for patients with dual diagnosis<br>|
| Active Comparator: Control<br> | Behavioral: regular treatment<br>* regular treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use |  | one year | 
| Substance use |  | 3 months | 
| Substance use |  | 6 months | 
| Change in drug use motivation |  | 3 months | 
| Change in drug use motivation |  | 6 months | 
| Change in drug use motivation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KLIPS
Mechanisms of Social Inequalities in Post-hospitalization Rehabilitation in Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR) attendance and uncover mechanisms of CR non-attendance. Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level, comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are predictors of CR attendance. Hypothesis b: The expected social gradient in CR attendance is explained partly by differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and distance to the rehabilitation clinic.

Detailed Description
-----------------
Design: Quantitative, observational, prospective study. Self-administrated questionnaires, medical journals and telephone interviews will be used for data collecting.

Official Title
-----------------
Mechanisms of Social Inequalities in Post-hospitalization Rehabilitation in Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267). Exclusion Criteria: Patients who are not able to submit written consent are excluded. Thus, patients with severe cognitive dysfunction or poor language skills are excluded.
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 |
| --- | --- | --- |
| Cardiac-rehabilitation attendance (yes/no) |  | 3 months post hospitalization |