linjc16/ctgov huggingface dataset:
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement treatment efficacy when compared to patients with chronic pain managed with oral or systemic opioid therapies. Our secondary hypothesis is that patients with intrathecal delivery systems for chronic non-cancer pain will report no improvement in treatment efficacy when compared to patients with chronic pain who are managed with non-opioid therapies.

Official Title
-----------------
Intrathecal Therapy for Chronic Non-Cancer Pain: An Analysis of Its Efficacy

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females greater than 18 years of age with legal decision making ability. Subjects receiving care at the Brigham and Women's Hospital Pain Management Center. Subjects must have a history of chronic pain > 6 months and must have been a patient in the BWH Pain Center > 6 months. Exclusion Criteria: Pain due to metastatic cancer or to cancer that is locally invasive Patients with a primary diagnosis of spasticity, receiving intrathecal baclofen Evidence of psychosis or hospitalization for psychiatric illness during study Pregnancy at any time during the study Altered mental status that would make subject unable to complete outcome questionnaires Significant chronic medical illness, such that requires frequent hospitalization or health care utilization (ie: renal failure requiring dialysis, heart failure or cardiac disease requiring surgery or intensive care admission, pulmonary disease requiring intubation or hospitalization, pancreatitis requiring hospitalization, vascular disease requiring surgery or hospitalization, etc.)

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 |
| --- | --- |
| IT opioids<br>Patients with IT pumps receiving IT opioids | |
| Systemic opioids<br>Patients taking oral or transdermal opioids for chronic pain | |
| Non-opioid management<br>Patients managing chronic pain without taking opioids | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Efficacy of Intrathecal Infusions | The primary objective of this study is to evaluate the treatment efficacy of intrathecal infusions for chronic pain and compare this form of therapy to systemic opioid therapy and non-opioid therapy for chronic pain > 6 months duration. | March 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pain, Intrathecal pain management
Prognostic Significance of Red Blood Cell

Study Overview
=================
Brief Summary
-----------------
Red blood cell (RBC) distribution width (RDW), calculated by dividing the standard deviation of RBC volume by the mean corpuscular volume and multiplied by 100, is routinely reported as part of the complete blood count (CBC) using automated flow cytometry. RDW has been traditionally used as additional information in the differential diagnosis of the cause of anemia. RDW has been recently reported as a strong prognostic factor in several diseases of various organ systems, including the cardiovascular, respiratory, renal, neurologic, and gastrointestinal systems.It also showed significant associations with ventilator-free days, postoperative outcome, intensive care unit (ICU) discharge outcome, out-of-hospital outcome, and all-cause mortality in critically ill patients. However, most studies were conducted in adult patients. Only a few studies have investigated RDW in children, especially in the critically ill pediatric population.

Detailed Description
-----------------
The aim of this study is to know the prognostic significance of red blood cell distribution width ( RDW ) in critically ill pediatric patients as regard ; the duration of hospital & PICU admission ,the use of inotropic drugs and or mechanical ventilation (MV) and the outcome of the case .

Official Title
-----------------
Prognostic Significance of Red Blood Cell Distribution Width (RDW) in Critically Ill Pediatric Patients at Sohag University Hospital

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All critically ill pediatric patients, 1 month to 12 years age, admitted to Pediatric intermediate & Intensive Care Unit ( PICU ) in Sohag University Hospital. Exclusion Criteria: - patients who received blood transfusion prior to admission in PICU patients with incomplete data for pediatric risk of mortality (PRISM), pediatric sequential organ failure assessment (pSOFA), pediatric logistic organ dysfunction-2 (PELOD-2), and pediatric multiple organ dysfunction syndrome (pMODS) scores were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of hospital admission | in days | 6 months |
Clinical Evaluation of NIR (Non-Invasive Infrared) Thermometer Performance

Study Overview
=================
Brief Summary
-----------------
The study is conducted in order to evaluate the performance of the NIT thrmometer by comparing the predictive measurement to equilibrium measurement and to make a final tuning to the thermometer algorithm.

Conditions
-----------------
Elevated Temperature

Intervention / Treatment
-----------------
* Device: NIR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 0-18 years old, with or without fever that arrive at the unit of emergency medicine in Schneider medical center. An informed Consent was signed by the patient or his guardian. Exclusion Criteria: The medical stuff decides that the patient can't participate.

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| With fever<br> | Device: NIR<br>* Thermometer<br>|
| Without fever<br> | Device: NIR<br>* Thermometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neuromodulation and Fatigue

Study Overview
=================
Brief Summary
-----------------
In this project, we aim to determine any potential effects of a weak electrical current applied to the neck or thoracic area on functional capacity and muscle activation. Healthy individuals will participate in one familiarization followed by three experimental sessions. Fatigability and motor function will be assessed in each test session.

Official Title
-----------------
Neuromodulation and Fatigue

Conditions
-----------------
Healthy Aging, Fatigue

Intervention / Treatment
-----------------
* Behavioral: electrical stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals between 18 and 50 years old Exclusion Criteria: Metal implants or joint replacement. Presence of neuromuscular disease. Skin hypersensitivity.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men<br>Individuals will participate in 1 familiarization and 3 test sessions | Behavioral: electrical stimulation<br>* different types of weak electrical stimulation will be used<br>|
| Experimental: Women<br>Individuals will participate in 1 familiarization and 3 test sessions | Behavioral: electrical stimulation<br>* different types of weak electrical stimulation will be used<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force | Change in force will be evaluated with a device during each test session | Each session will take approximately 2 hours (total of 4 test sessions) | 
| Perception of effort | Change in perceived effort will be evaluated with visual analogue scales | Each session will take approximately 2 hours (total of 4 test sessions) | 
| Muscle activation | Electromyography will be used to quantify muscle activation | Each session will take approximately 2 hours (total of 4 test sessions) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TsDCS, Transcutaneous spinal direct current stimulation, Fatigability
Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

Study Overview
=================
Brief Summary
-----------------
Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design.

Detailed Description
-----------------
Aortic valve stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS has long been considered as a passive and degenerative process. Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis. However, pathophysiology of AS remains poorly understood and preliminary data suggest that genetic factors may be involved. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design (1000 patients with AS and 1500 controls with no evidence of valve disease). For all patients and controls, blood samples including DNA and echocardiography will be performed.

Official Title
-----------------
Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients: Inclusion criteria : Age >=18 years Pure isolated degenerative aortic valve stenosis Exclusion criteria : Rheumatic, congenital or post-radiation aortic stenosis Severe renal insufficiency (clearance < 30 ml/min) Aortic insufficiency > or = grade 2/4 Other valve disease > or = grade 2/4 Controls Inclusion criteria : - Age >=18 years Exclusion criteria : Known first degree relative with aortic valve stenosis Severe renal insufficiency (clearance < 30 ml/min) Any valve disease > or = grade 2/4

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 |
| --- | --- |
| aortic stenosis<br>various age and disease severity | |
| Controls<br>Controls free of valvular disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of genetic polymorphisms of fetuin-A, matrix-GLA protein, vitamin D receptor |  | end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of other genetic polymorphisms |  | End of the Study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic Valve stenosis, Genetic, Mineralisation inhibitors
A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this trial was to assess subject preference for PARCOPA, carbidopa/levodopa Orally Disintegrating Tablets (ODT), compared with conventional carbidopa/levodopa tablets, in subjects with stable Parkinson's disease.

Detailed Description
-----------------
See approved Package Insert for Adverse Event information.

Official Title
-----------------
A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: PARCOPA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable Parkinson's Disease Exclusion Criteria: Not using carbidopa/levodopa tablets

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Real-world Aliskiren Use in Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate real-world patterns of aliskiren use with a focus of change in renal function following aliskiren initiation as well as to identify triggering events that lead to aliskiren initiation.

Official Title
-----------------
Aliskiren Use in Diabetic Patients: Who's Using it, Why, and How is it Working ?

Conditions
-----------------
Diabetes, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Patients ages 18 yeras and older Hypertension Diagnosis Currently on at least 1 hypertensive medication At least 2 lab measure before and after aliskiren initiation Exclusion Criteria: Inadequate chart records where microalbuminuria, serum creatinine and blood pressure data are not within 3-12 months prior to initiation of Aliskiren Pregnancy Development of secondary renal disease unrelated to diabetes (such as nephritis) Terminal illness AIDS/HIV Other protocol-defined inclusion/exclusion criteria may apply

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 |
| --- | --- |
| Aliskiren<br>Diabetic nephropathy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change in blood pressure |  | baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Change in urine microalbumin |  | baseline and 1 year | 
| Measure: Change in creatinine |  | baseline and 1 year | 
| Measure: Change in potassium levels |  | baseline and 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, aliskiren, hypertension, renal impairment
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. Also, to determine the effect of Liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.

Official Title
-----------------
Inflammation, Immune Activation and Portal Hypertension in Alcoholic Hepatitis. A Pato-etiological Study With Focus on the Endotoxin Pathway.

Conditions
-----------------
Alcoholic Hepatitis

Intervention / Treatment
-----------------
* Device: Prometheus Liver Dialysis system (Fresenius Medical Care)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with alcoholic hepatitis based on the following criteria Alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier. Serum bilirubin level above 80 mmol/l exclusion of other types of liver disease. Liver biopsy when diagnosis is unclear. Exclusion Criteria: Heart failure Pregnancy non fluent danish speakers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: albumin liver dialysis<br> | Device: Prometheus Liver Dialysis system (Fresenius Medical Care)<br>* 6 hour dialysis for 3 consecutive days<br>* Other names: The prometheus albumin dialysis by Fresenius Medical Care;|
| No Intervention: Standard medial care without dialysis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum endotoxin levels |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotoxin activation pathway proteins |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, Alcoholic Hepatitis, Endotoxin, LPS, Liver dialysis, Innate immunity, Toll Like receptors
Pattern and Management of Intracranial Cavernoma

Study Overview
=================
Brief Summary
-----------------
Intracranial cavernous vascular malformations are variously known as cavernous angiomas, cavernous hemangiomas, or, more simply, cavernomas. Cavernomas are congenital low flow vascular lesions. It composed of irregular sinusoidal vascular channels, lacking smooth muscle, and elastic fibers. They lack feeding arteries or draining veins and contain no neural tissue. The first description of an intracranial cavernoma was given by Virchow, in 1863. For over a century, it was considered to be an extremely rare malformation, usually found at autopsy, and exceptionally diagnosed during life. The prevalence of cerebral cavernous malformations (CCM) is estimated to be 0.4-0.9%.

Official Title
-----------------
Pattern and Management of Intracranial Cavernoma

Conditions
-----------------
Management of Intracranial Cavernous Hemangioma

Intervention / Treatment
-----------------
* Procedure: surgical excision of intracranial cavernoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presented with intracranial cavernomas (single or multiple, superficial or deep, supratentorial or infratentorial) Denovo or recurrent patients. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: surgical excision of intracranial cavernoma|microvascular excision of intracranial cavernoma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome | Measured by Modified Rankin Scale Measures the degree of disability or dependence in the daily activities of people who have suffered any cause of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | one month post operative |