linjc16/ctgov huggingface dataset:
Expression of Inflammasomes in HCV Patients

Study Overview
=================
Brief Summary
-----------------
Hepatitis C virus has been identified a quarter of a decade ago as a leading cause of chronic viral hepatitis that can lead to cirrhosis and hepatocellular carcinoma. Only a minority of patients can clear the virus spontaneously during acute infection. Elimination of HCV during acute infection correlates with a rapid induction of innate and a delayed induction of adaptive immune responses. The majority of patients is unable to clear the virus and develops viral persistence despite the ongoing innate and adaptive immune response. The virus usually develops several strategies to escape these immune responses.

Official Title
-----------------
Expression of Inflammasomes in HCV Patients Before and After Treatment

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Diagnostic Test: interleukin IL-1beta and interleukin IL-18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis C virus patients. Patients do not start treatment protocol. Exclusion Criteria: Pregnant women. Hepato-cellular carcinoma patients. Autoimmune disease patients. Patients with liver cirrhosis. Patients who refuse to participate in the study

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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: chronic hepatitis C virus patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chronic hepatitis C virus patients<br>50 chronic hepatitis C virus patients taking will be trated with direct acting antiviral treatment with three months regimen (Sofosbuvir + Daclatasvir). | Diagnostic Test: interleukin IL-1beta and interleukin IL-18<br>* pro-inflammatory cytokines measured in the serum<br>|
| Experimental: treated chronic hepatitis C virus patients<br>the selected 50 chronic hepatitis C virus patients received direct acting antivirals: Sofosbuvir 400 mg and Daclatasvir 60 mg daily for 12 weeks and were assessed for sustained virological response at 12 weeks following the end of treatment (SVR12). | Diagnostic Test: interleukin IL-1beta and interleukin IL-18<br>* pro-inflammatory cytokines measured in the serum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the exprssion level of inflammasomes | observe the changes in the exprssion level of inflammasomes in the selected chronic HCV patients before treatment with Sofosbuvir 400 mg and Daclatasvir 60 mg daily for 12 weeks and after sustained virological response at 12 weeks following the end of treatment (SVR12). | 6 monthes |
Mortality Among Children With Congenital Heart Defects in Norway

Study Overview
=================
Brief Summary
-----------------
To describe mortality among children with congenital heart defects in Norway

Official Title
-----------------
Mortality Among Children With Congenital Heart Defects in Norway

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with congenital heart defects Exclusion Criteria: no
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 |
| --- | --- | --- |
| Number of death until 31 dec 2012 among Norwegian children with congenital heart defects born 1994-2009 |  | 31.12.2010 |
Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller. The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.

Official Title
-----------------
A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Intravenous prednisolone
* Drug: Oral prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease [GOLD] severity stage II) Smoking history of > 10 pack years Exclusion Criteria: Signs of severe exacerbation (arterial pH < 7.26 or pCO2 > 9.3 kPa) History of asthma Significant or unstable co-morbidity Participated in another study 4 weeks before admission Previously randomized to this study Findings on chest radiography other than those fitting with signs of COPD Known hypersensitivity to prednisolone Non-compliant

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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: Intravenous prednisolone|nan|
|Drug: Oral prednisolone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure defined as: death from any cause |  |  | 
| admission to the intensive care unit |  |  | 
| readmission to the hospital because of COPD |  |  | 
| and the necessity to intensify pharmacologic treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in forced expiratory volume in 1 second (FEV1) |  |  | 
| St. George's Respiratory Questionnaire (SGRQ) scores |  |  | 
| Clinical COPD Questionnaire (CCQ) scores |  |  | 
| and length of hospital stay |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Exacerbations, Corticosteroids, Oral, Intravenous, Chronic Obstructive Pulmonary Disease (COPD)
A Safety Study of TTP4000 in Subjects With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the safety, tolerability, immunogenicity and pharmacokinetics of TTP4000 in subjects with Alzheimer's disease with mild cognitive impairment.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Phase 1 Study of 2 Escalating, Single Subcutaneous Doses to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of TTP4000 in Subjects With Alzheimer's Disease With Mild Cognitive Impairment

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: TTP4000
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females ≥ 50 years of age. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. Weight ≥ 50 kg. Alzheimer's disease according to the DSM-IV-TR criteria and a score between 20 and 26 on the Mini Mental State Exam. Subject must have a medical history for at least 6 months prior to Screening (confirmed by medical records) of a diagnosis of mild Alzheimer's disease. Exclusion Criteria: Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including, but not limited to: epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, or head injury with loss of consciousness; DSM-IV-TR criteria for any major psychiatric disorder, including psychosis, major depression, and bipolar disorder. Participation and dosing in another clinical trial, involving any marketed or investigational drug, within 30 days before Screening Visit.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TTP4000 1.0 mg/kg<br>Administered subcutaneously | Drug: TTP4000<br> <br> |
| Experimental: TTP4000 3.0 mg/kg<br>Administered subcutaneously | Drug: TTP4000<br> <br> |
| Placebo Comparator: Placebo<br>Administered subcutaneously | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant with adverse events |  | Day 0 to Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of participant plasma TTP4000 concentrations |  | Day 0 to Day 84 |
Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department

Study Overview
=================
Brief Summary
-----------------
fluid therapy is one of the cornerstones in the management of shock but may result in iatrogenic fluid overload .The aim of this study was to assess the role of echocardiography in guiding fluid therapy in shocked patients with impaired cardiac contractility using straight leg raising test ,Inferior vena-cava collapsability index and Doppler imaging in Emergency Department in Alexandria main university hospital.

Official Title
-----------------
Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department

Conditions
-----------------
Shock

Intervention / Treatment
-----------------
* Diagnostic Test: passive leg raising test and fluid challenge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: shocked patient with impaired cardiac contractility Exclusion Criteria: Trauma patients. Patient with unstable arrhythmias. Patients with lower limb amputation. Mechanically ventilated patients. Patients with prosthetic aortic valve. Patients less than 18 years old Pregnant.

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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: shocked patient with impaired cardiac contractility<br> | Diagnostic Test: passive leg raising test and fluid challenge<br>* Shocked patients were subjected to echocardiographic examination if (EF <52%) .baseline LVOT VTI was obtained Then IVC scanning was done through subcostal Window and using M-mode the minimum and the maximum diameters were measured then the collapsibility index was calculated Then passive leg raising test was done Patients who tolerated the PLR test and did not develop clinical or lung ultrasound signs of fluid overload (lung congestion) were given IV fluid bolus (250 ml normal saline) over 10 minutes followed by measurement of LVOT VTI. Patients who did not tolerate PLR test or developed clinical or lung ultrasound signs of fluid overload (lung congestion) during PLR test were excluded from the third step (fluid challenge). The differentiating factor used to allocate patient in which group (non-responder or responder) was LVOT VTI variability after fluid challenge (our gold standard to assess fluid responsiveness).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVOT VTI variability | variability of LVOT VTI to determine fluid responsiveness | 15 minutes |
Functional MRI of Cognitive Control in Autism

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the role of fronto-striatal circuits and cognitive control in the perseverative and inflexible behavior that is a defining feature of autism. We hypothesize that deficits in the development of fronto-striatal circuitry may underlie cognitive inflexibility in autism. Specifically, we hypothesize that repetitive, inflexible behavior arises as (1) fronto-striatal systems are capable of learning patterns present in the environment (as in implicit learning paradigms), but are unable to adapt behavior to changing circumstances, related to either (2) decreased ability of basal ganglia to detect violations of expectancy, (3) decreased ability of prefrontal cortex to respond to detected violations, or (4) decreased connectivity of the circuits. We are conducting three functional Magnetic Resonance Imaging (fMRI) studies to address these hypotheses.

Official Title
-----------------
Functional MRI of Cognitive Control in Autism

Conditions
-----------------
Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 6 - 12 years at inclusion Inclusion criteria for subjects with autism DSM-IV (APA, 1994) diagnosis of autism, according to ADI-R interview Inclusion criteria for controls No DSM-IV (APA, 1994) diagnosis, according to DISC interview No scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF) IQ > 70 Exclusion Criteria: Major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system Presence of metal objects in or around the body (pacemaker, dental braces) History of or present neurological disorder

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional MRI
Prevention and Control of Healthcare-Associated Infections

Study Overview
=================
Brief Summary
-----------------
Bundling infection control interventions should decrease incidence of Healthcare-Associated Infections in General Medical Wards at Siriraj Hospital, Bangkok, Thailand

Official Title
-----------------
Randomized Controlled Study on Effectiveness of Implementing Bundling Infection Control Interventions for Prevention and Control of Healthcare-Associated Infections in General Medical Wards at Siriraj Hospital, Bangkok, Thailand

Conditions
-----------------
Nosocomial Infection

Intervention / Treatment
-----------------
* Other: Bundling Infection Control Interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients hospitalized to general medical wards Exclusion Criteria: The patients hospitalized less than 48 hours

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infection control measure<br>Bundling Infection Control Interventions | Other: Bundling Infection Control Interventions<br>* identify risk factors for developing HAIs, receive general infection control measures as well as infection control measures appropriate for the identified risk factor (s)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of healthcare-associated infection |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hospital-acquired pneumonia and catheter-associated UTI |  | 7 months |
Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?

Study Overview
=================
Brief Summary
-----------------
To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.

Official Title
-----------------
Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?

Conditions
-----------------
HHV6, Exanthema, Hemopathy

Intervention / Treatment
-----------------
* Other: Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Supported for any type of hemopathy. Allograft, autografted or ungrafted haematopoietic stem cells Having presented an exanthema during hospitalization, for which a cutaneous biopsy had been performed Having had a blood test of the HHV6 virus by PCR at least within the previous 40 days or following the rash. Age greater than or equal to 18 years Patient informed of the protocol by post, not having refused within one month of sending the said courier. Exclusion Criteria: Patient who refused the search. Patient whose HHV6 PCR in the blood was carried out at a distance of more than 40 days from the skin biopsy.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.|To evaluate the prevalence of the positivity of HHV6 PCR in the skin, during the exanthema in patients hospitalized for haemopathy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied. |  | 1 day |
Newborn Health Information Study

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled trial to test the use of an educational video during the newborn well-child visit. Parents who watch the video during their medical visit will be compared to those parents who receive traditional paper handouts. Measures obtained at baseline and 2-week follow-up include knowledge of infant development, self-efficacy with infant care, and problem-solving skills.

Official Title
-----------------
Innovative Delivery of Newborn Anticipatory Guidance: The Incorporation of Media-Based Learning Into the Primary Care Office.

Conditions
-----------------
Infant, Newborn

Intervention / Treatment
-----------------
* Behavioral: DVD/Video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Baby's first visit to the pediatric office Exclusion Criteria: Baby > 1 month old Parent/Caregiver < 18yrs old Inability to understand English No access to a working telephone

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

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DVD/Video<br>Parents of newborns in the experimental group attending their first baby visit will be shown a video about newborn care. | Behavioral: DVD/Video<br>* One DVD or Video will be watched by all parents of newborns enrolled into the experimental group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of Infant Development |  | 2 weeks |