linjc16/ctgov huggingface dataset:
Pediatric EEG Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand if a new, smart, wireless EEG developed by our team can be used to monitor the continuous electrical activity of the brain in the ICU and EMU and whether it works as well as the current standard, wired EEGs.

Detailed Description
-----------------
The investigators propose to 1) optimize these devices for use in pediatric ICU patients, 2) demonstrate safety, reliability, and accuracy of these devices for continuous ICU EEG signal measurements, and 3) demonstrate these devices are preferred by patients and parents to current EEG devices. Once validated, such sensors could fundamentally change the way patients are monitored by EEG in the ICU, allowing wireless, continuous, real-time detection of brain wave activity in ICU patients, reducing limitations in mobility as well as access by staff and caregivers to the patient, and ultimately offering opportunity to reduce morbidity and mortality in ICU patients.

Official Title
-----------------
Evaluation of a Wireless EEG Monitor for Pediatric Patients

Conditions
-----------------
Pediatric ALL, Epilepsy

Intervention / Treatment
-----------------
* Device: wearable EEG sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be admitted to the PICU or EMU at Lurie Children's and are prescribed an EEG as part of their standard of care. Exclusion Criteria: Anyone with a skin abnormality that would potentially increase the risk of device use will be excluded. Ages 18 years or older. Any patient or family determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family) will not be approached for recruitment.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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: wearable EEG sensor|Wireless wearable EEG devices offer a new, non-invasive, and easy way of performing EEG monitoring.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Agreement | Percent agreement between experimental sensor and commercially available electroencephalogram (EEG) | 3 years |
Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
Accelerated atherosclerosis in patients with systemic lupus erythematosus (SLE) is not fully explained by Framingham risk factors. The detection in asymptomatic patients of somatic mutations in genes involved in hematopoietic malignancy- defining clonal hematopoiesis of indeterminate potential (CHIP) - predisposes to cardiovascular events (CVE) in general population. We aimed to determine whether CHIP is associated with CVE in SLE.

Detailed Description
-----------------
SLE patients indeed display an accelerated atherosclerosis that strongly contributes to the excess mortality observed but is poorly explained by the traditional cardiovascular risk factors. Clonal hematopoiesis defines the clonal expansion of hematopoietic cells driven by a selective advantage given by leukemia-associated somatic mutations. Clonal hematopoiesis is said of indeterminate potential (CHIP) when found in asymptomatic patient. CHIP strongly correlated with age and logically predispose to haematological malignancy, but is also causally associated with cardiovascular events (CVE) in the general population. The main objective of our study was to determine whether CHIP is associated with CVE in SLE patients.

Official Title
-----------------
Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Patients With Systemic Lupus Erythematosus

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a systemic lupus erythematosus Exclusion Criteria: Inadequate follow-up period (< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study
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 |
| --- | --- | --- |
| The primary outcome was the occurrence of cardiovascular events (CVE) over follow-up. | Incidents CVE were ascertained by physician interview using a standardized questionnaire and through examination of medical records. CVE included coronary heart disease, stroke, revascularization procedure for other atherosclerotic cardiovascular diseases and sudden cardiac death. Coronary heart disease was defined as a history of angina, coronary revascularization, or myocardial infarction. All CVE that occurred through March 2019 were considered for analysis | >20 months after PLUS inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of CHIP in SLE |  | at PLUS inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic lupus erythematosus, Clonal hematopoiesis of indeterminate potential, Cardiovascular events
Indication of Ceaseran Section in Primigravida According to Robson's Classification

Study Overview
=================
Brief Summary
-----------------
Rate of caesarean section surgery are rising worldwide,but the determinant of this increase,especially in low-income and middle-income countries, are controversial.In 1985,The world Health organization (WHO) stated;(There is no justification for any region to have a ceasearan section rate higher than 10-15%). Despite the lack of scientific evidence indicating any substantial maternal and perinatal benefits from increasing cs rates,and some studies showing that higher rates could be linked to negative consequences in maternal and child health, CS continue to increase world wide

Official Title
-----------------
Indication of Ceaseran Section in Primigravida According to Robson's Classification

Conditions
-----------------
CESAREAN SECTION

Intervention / Treatment
-----------------
* Procedure: cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nullipara Single fetus . More than 37 weeks . Patients who pass into spontaneous Patient who induced labour Exclusion Criteria: Non cephalic presentation. Abnormal lie
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>primigravida scheduled for cesarean section | Procedure: cesarean section<br>* lower segment cesarean section either elective or emergency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of etiologies of cesarean section | determine the rate of cesarean section with different indication according to Robson classification | one month |
Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

Study Overview
=================
Brief Summary
-----------------
The performance of 3 different sampling methods (2 nasopharyngeal swabs, 1 oropharyngeal swab) for the detection of SARS-CoV-2 with real-time reverse transcriptase polymerase chain reaction will be compared.

Detailed Description
-----------------
Thirty volunteers will be recruited from health care workers suspicious for Covid-19, who consult the ocupational physician for Covid-19 testing. For each volunteer, 3 swabs will be taken: Flocked eSwab (Copan, Italy) of the oropharynx Flocked nasopharyngeal eSwab (Copan, Italy) of the nasopharynx Dry flocked nasopharyngeal Swab, placed in lysis buffer Each swab will be tested for the presence of SARS-CoV-2 with an in-house reverse-transcriptase real-time PCR (Egene). Performance of each method will be calculated.

Official Title
-----------------
Comparison of the Performance of 3 Sampling Methods for the Detection of SARS-CoV-2 (COVID-19) With Real-time Reverse Transcriptase PCR

Conditions
-----------------
Covid-19, SARS-CoV-2, Diagnosis, Polymerase Chain Reaction

Intervention / Treatment
-----------------
* Other: samling of oropharynx and nasopharynx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: health care workers with symptoms suspicious for Covid-19 Exclusion Criteria: none
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
Interventional Model Description: Beside the regular sampling method of 1 nasopharyngeal swab, 2 extra swabs will be taken in each volunteer. Performance of the 3 methods for laboratory diagnosis by PCR of Covid-19 will be compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Health Care Workers with Covid-19 symptoms<br>3 samples (2 nasopharyngeasl swabs, 1 oropharyngeal swab) willl be taken from each volunteer | Other: samling of oropharynx and nasopharynx<br>* Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity | sensitivity of each sampling method for the detection of SARS-CoV-2 by RT-PCR | 1 month |
A Study of Disease Progression and Anti-HIV Treatments

Study Overview
=================
Brief Summary
-----------------
To determine the influence of virus load, CD4 count, biologic phenotype, and presence of symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen. PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment for 6 months.

Official Title
-----------------
Influence of Risk Status for Disease Progression on the Response to Antiretroviral Interventions: A Follow-up Study to ACTG 175

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Prior participation on protocol ACTG 175. PER AMENDMENT 8/27/96: Patients must be on study/on treatment at the time the protocol study treatment is extended.

Ages Eligible for Study
-----------------
Minimum Age: 12 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


Arms and Interventions

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

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
-----------------
Zalcitabine, Didanosine, Drug Therapy, Combination, AIDS-Related Complex, Antiviral Agents, Zidovudine, Lamivudine
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia

Study Overview
=================
Brief Summary
-----------------
This is a study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained study staff to determine if bacterial pneumonia is present. Results of the thermal images will then be compared to the results of the chest X-ray. If additional images of the chest are available, additional thermal images will be taken of the same location within 24 hours of the other image.

Official Title
-----------------
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia

Conditions
-----------------
Pneumonia, Bacterial, Infections, Bacterial

Intervention / Treatment
-----------------
* Other: Thermal imaging of infant's chest with a mobile phone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient at Queen Elizabeth Central Hospital in Blantyre, Malawi having chest x-ray done to rule out pneumonia thermal image can be taken within 24 hours of chest x-ray parent/guardian provides written informed consent Exclusion Criteria: none

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants with potential pneumonia<br> | Other: Thermal imaging of infant's chest with a mobile phone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of concordance between thermal image and the concurrent chest x-ray regarding the diagnosis of bacterial pneumonia |  | Within 24 hours of the chest x-ray | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bacterial pneumonia, children, diagnosing pneumonia, thermal imaging
Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

Study Overview
=================
Brief Summary
-----------------
To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.

Detailed Description
-----------------
One of the most serious complications of treatment in patients with hemophilia A or hemophilia B is the development of an inhibitor, which is an antibody that neutralizes the factor VIII or IX coagulant activity. Up to one fourth of patients with severe hemophilia A develop an inhibitor but at present it is not possible to predict which patients will develop such antibody. The ability to predict an inhibitor development at an individual level would greatly improve therapeutic approach to this serious problem

Official Title
-----------------
Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

Conditions
-----------------
Hemophilia A

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher Exclusion Criteria: Severe Hemophilia A with a negative inhibitor

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 99 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 |
| --- | --- | --- |
| Inactivation of antibodies by the FVIII covalent reactive analogs |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhibitors
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)

Study Overview
=================
Brief Summary
-----------------
To determine if supplements of vitamin C, vitamin E, beta-carotene, and B-vitamins (a combination of folic acid, vitamins B6 and B12) reduce risk of major cardiovascular events in high risk women with a prior history of atherosclerotic cardiovascular disease. The trial is a companion to the Women's Health Study (WHS), a primary prevention trial of vitamin E and aspirin in a low risk population of women.

Detailed Description
-----------------
The Women's Antioxidant and Folic Acid Cardiovascular Study tested the effects of vitamin C (500 mg/day), vitamin E (600 IU every other day), and/or beta carotene (50 mg every other day) on the risk of major cardiovascular events (a combined outcome of myocardial infarction, stroke, coronary revascularization, or cardiovascular death) among 8171 female health professionals at increased risk. Participants were 40 years or older with a history of cardiovascular disease or 3 or more cardiovascular risk factors and were followed for an average duration of 9.4 years, from 1995-1996 to 2005. In 1998, 5442 of these participants were further randomized to the B-vitamin intervention (a daily combination pill containing folic acid [2.5 mg], vitamin B6 [50 mg], vitamin B12 [1 mg]) and were followed for 7.3 years, from April 1998 through July 2005.

Official Title
-----------------
Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)

Conditions
-----------------
Cardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia

Intervention / Treatment
-----------------
* Behavioral: dietary supplements
* Drug: vitamin C
* Drug: vitamin E
* Drug: beta-carotene
* Drug: folic acid/Vitamin B6/Vitamin B12


Participation Criteria
=================
Eligibility Criteria
-----------------
Women, aged 40 and over, at high risk, with a history of cardiovascular disease or three or more coronary heart disease risk factors.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: dietary supplements|nan|
|Drug: vitamin C|nan|
|Drug: vitamin E|nan|
|Drug: beta-carotene|nan|
|Drug: folic acid/Vitamin B6/Vitamin B12|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease |  |  | 
| Cancer |  |  |
RNA-seq Analysis of PBMC in Patients With OPLL

Study Overview
=================
Brief Summary
-----------------
In this study, we planned to identify transcriptome expression profiles (circRNAs, lncRNAs, and mRNAs) from peripheral blood mononuclear cells (PBMCs) of 30 patients with OPLL and 30 other non-OPLL patients by high-throughput sequencing.Sequence analysis was used to predict miRNAs that might bind circRNAs and lncRNAs.Through bioinformatics analysis, competitive endogenous RNAs (cerRNAs), as well as coexpression networks among circRNAs, lncRNAs, miRNAs, and mRNAs, were constructed to provide key molecules and signaling pathways associated with OPLL.

Official Title
-----------------
Characteristics of Transcriptome Expression Profile of PBMCs in Patients With Ossification of the Posterior Longitudinal Ligament

Conditions
-----------------
OPLL, PBMCs, Transcriptome, Bioinformatics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntarily participate in the clinical study and sign the informed consent; All OPLL patients meet the diagnostic criteria set out in the JOA Clinical Practice Guidelines for Spinal Ligament Osification 2019; Age ≥18, gender unlimited; All non-OPLL patients and healthy volunteers have no serious diseases of the heart, lung, brain, liver, kidney and blood system, such as autoimmune diseases, tumors, psychosis, infectious diseases, etc., and have no bad habits or recent history of taking special drugs. Exclusion Criteria: Unable to sign the informed consent; Patients who do not meet the inclusion criteria or diagnostic criteria; <18 years old; Women planning to become pregnant/lactating/pregnant; Complicated with serious heart, lung, brain, liver, kidney, blood system diseases, such as autoimmune diseases, tumors, mental illness, infectious diseases, drug addiction and other bad addicts;Those who have recently taken special drugs; Individuals who do not agree to donate peripheral blood or who are obviously uncomfortable with drawing blood.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| circRNA, lncRNA, mRNA |  | 1 year |
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7 days in children with community-acquired pneumonia (CAP). Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of telithromycin 20 mg/kg qd for 5-7 days in children with CAP.

Official Title
-----------------
Evaluation of the Safety, Pharmacokinetics, Efficacy, and Acceptability of HMR3647 20 mg/kg qd for 5-7 Days With Community-Acquired Pneumonia (CAP) in Children (Multicenter, Open Label, Noncomparative Study)

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: Telithromycin (HMR3647)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are weighing 40 kg or less. If female, premenarchal status is required. Subjects who are diagnosed with CAP based on chest X-ray showing the presence of a new infiltrate, clinical symptoms, and laboratory findings. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telithromycin (HMR3647)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy: change in the symptoms and signs |  |  | 
| Acceptability: compliance and willingness to take medication |  |  | 
| Pharmacokinetics: plasma concentrations of telithromycin |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community-Acquired pneumonia, CAP, children, Child