linjc16/ctgov huggingface dataset:
The Effect of Niacin Administration on Oxidative Stress in Patients With Hypercholesterolmia, as Measured by the Use of a Novel Biomarker

Study Overview
=================
Brief Summary
-----------------
Treatment of Hypercholesterolemic patients with niacin will cause a significant decrease in oxidative stress and a decrease in the atherogenecity in blood samples of the patients. A possible correlation between oxidative stress in hypercholesterolemic patients taking niacin to clinical hypercholesterolemia parameters is possible. Using a novel biomarker will enable a precise detection of the change in the oxidative stress in hypercholesterolemic patients.

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Niacin\Laropiprant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypercholesterolemia, age above eighteen Exclusion Criteria: Treatment with fibrates, Pregnant/Breast feeding women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Niacin<br>Hypercholesterolemic patients with high-density lipoprotein (HDL) less than 40 mg% will receive Niacin\Laropiprant. | Drug: Niacin\Laropiprant<br>* Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant<br>|
| No Intervention: Control<br>Maching subjects will receive no medication, Blood tests will be drawn for laboratory tests. | Drug: Niacin\Laropiprant<br>* Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on oxidative stress |  | three months |
Clinical Performance Evaluation of DxN CMV Assay

Study Overview
=================
Brief Summary
-----------------
The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.

Detailed Description
-----------------
same as brief summary

Official Title
-----------------
Clinical Performance Evaluation of DxN CMV Assay

Conditions
-----------------
Cytomegalovirus

Intervention / Treatment
-----------------
* Diagnostic Test: CMV Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Must have had a kidney transplant and be evaluated for post-transplantation care Must have demonstrated post-transplant CMV DNAemia Must be eligible for and treated with anti-CMV drugs Exclusion Criteria: HIV positive Proven ganciclovir or valganciclovir resistance

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 |
| --- | --- |
| CMV infected<br>CMV infected observational study testing using DxN CMV Assay. Study is observational and results not used to manage patient care. | Diagnostic Test: CMV Assay<br>* Molecular diagnostic test to detect CMV<br>* Other names: DxN CMV Assay;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virological response to therapy | Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results | 5 months |
Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to determine if non-invasive imaging with state of the art CT coronary angiography can be used to screen for coronary artery disease in high risk patients prior to liver and lung transplantation. The current protocol for coronary artery disease assessment at UCSF before liver and lung transplantation involves screening with stress tests and/or coronary angiograms in patients with increased risk of coronary artery disease. Coronary angiogram will be used as gold standard for assessment of coronary CTA accuracy.

Official Title
-----------------
Comparison of Coronary CT Angiography With Conventional Coronary Angiography in Liver and Lung Transplant Candidates.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver transplant candidates referred for invasive coronary angiography which include: Patients with suspicious symptoms for CAD or; Asymptomatic patients; Abnormal non-invasive testing or 1 major risk factor for coronary artery disease or LVEF < 60% on echo. Lung transplant candidates referred for invasive coronary angiography which include: Patients with suspicious symptoms for CAD or; Asymptomatic patients; Abnormal non-invasive testing or 1 major risk factor for coronary artery disease or LVEF < 60% on echo in patients with low SVR (typical for ESLD). Any ethnic background is acceptable. Exclusion Criteria: Patients with contraindications for the use of iodinated contrast (allergic reaction, renal failure, multiple myeloma, etc) will be excluded. Children and pregnant women will be excluded because of risks associated with radiation exposure. Patients must have no atrial fibrillation, as this will interfere with cardiac gating for the examination. Patients unable to give informed consent will be excluded as well.

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 |
| --- | --- |
| 1<br>Liver and lung transplant candidates referred for coronary angiography will be invited to participate in the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients suspected of having coronary artery disease (CAD) |  | 1-30 days before invasive coronary angiography is performed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive coronary angiography, multidetector coronary CTA, coronary artery disease, detecting coronary artery disease
Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure, and/or until a new clinical trial is available and the patients in treatment under Expanded Access are eligible to participate in the new trial.

Official Title
-----------------
Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

Conditions
-----------------
Ligneous Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Plasminogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with LC associated with Type I plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. The presence of membranes in different areas is not an exclusion criterion. Subjects and their legally authorized representative, in the case of subjects <18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the IRB. Subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule. Subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment. Exclusion Criteria: Subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment. Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device [IUD], abstinence or other prescribed birth control). Enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners. Females who are breastfeeding.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Plasminogen|Human Plasminogen|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of HCV-796 and a single dose of desipramine when coadministered to healthy subjects.

Official Title
-----------------
An Open-Label, Single-Dose Desipramine, Multiple-Dose HCV-796, Sequential 3-Period Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: HCV-796
* Drug: Desipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HCV-796|HCV-796 500mg BID x 14 days|
|Drug: Desipramine|Period 1: Single oral dose of desipramine (50 mg) on day 1. No test article administration on days 2 to 6. Period 2: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 1 to 9. Period 3: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 10 to 14 and a single oral dose of desipramine (50 mg) on day 10.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 29 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
Identification of Noninvasive Biomarkers for Neonates Undergoing Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
To identify the potential serum and radiological biomarkers with regard to neonates undergoing abdominal surgery, and to further evaluate the prognostic value of these markers.

Detailed Description
-----------------
First, the investigators will collect serum biomarkers in neonate patients receiving abdominal surgery. Then the investigators will identify the characteristics and change of biomarkers expressed in neonate patients before and after abdominal surgery. The investigators will further evaluate the prognostic value of these markers for neonate patients receiving abdominal surgery.

Official Title
-----------------
Identification of Noninvasive Biomarkers for Neonates Undergoing Abdominal Surgery

Conditions
-----------------
Biomarkers, Neonate

Intervention / Treatment
-----------------
* Other: Biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age up to 18 years old With written informed consent Exclusion Criteria: Clinical data missing Without written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort. | Other: Biomarkers<br>* Different serum and radiological biomarkers neonates undergoing abdominal surgery.<br>|
| Prospective cohort<br>The same inclusion/exclusion criteria were applied for the same center prospectively. It is a external validation cohort. | Other: Biomarkers<br>* Different serum and radiological biomarkers neonates undergoing abdominal surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of non-invasive biomarkers | These markers will be collected in association with the prognostication for neonates before and after surgery. | At least 5-year follow up |
Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function. Patients who will have a left ventricular assist device (LVAD) implanted while they wait for a donated heart will be treated with Anginera. At the time of heart transplant, their diseased heart which is removed will be analyzed by microscopic examination to see what effect Anginera had.

Detailed Description
-----------------
This will be a prospective, multi-center, randomized, open-label, within-patient paired design study. The primary purpose is to analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.

Official Title
-----------------
A Phase I Open Label Pilot Study to Obtain Tissue for Histological Analysis After Application of Anginera™ in Adults With A Left Ventricular Assist Device As A Bridge To Transplant

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

Intervention / Treatment
-----------------
* Drug: Anginera, a human tissue replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage D Heart Failure Patients having an LVAD implanted as a bridge to transplant. Exclusion Criteria: Biopsy proven acute myocarditis Known Giant Cell Myocarditis Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anginera, a human tissue replacement therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers. |  |  | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anginera, LVAD, Transplant, Histology, LVAD implantation as a bridge to transplant
Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.

Official Title
-----------------
An Open-label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate

Conditions
-----------------
Advanced Gastrointestinal Stromal Tumor

Intervention / Treatment
-----------------
* Drug: AMG 706


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of histological confirmed GIST Had prior imatinib mesylate therapy Has at least 1 measurable leasion by modified RECIST Exclusion Criteria: Central nervous system tumor involvement requiring treatment History of myocardial infraction Uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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: Arm One<br>AMG 706 125mg, oral, once a day | Drug: AMG 706<br>* AMG 706 125mg, oral, once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective response rate as assessed by modified RECIST |  | Every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response, progression-free survival, time to response, overall survival, PK and safety profile |  | imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter; | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706
COVID-19 Vaccines Associated Malaise

Study Overview
=================
Brief Summary
-----------------
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines. To do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in VigiBase®, the WHO pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all COVID-19 vaccines on the market and malaise. Demographic data were also analyzed.

Official Title
-----------------
COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database

Conditions
-----------------
Vaccine Adverse Reaction

Intervention / Treatment
-----------------
* Drug: SARS-CoV-2 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adverse events reported in the WHO pharmacovigilance database Exclusion Criteria: none
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 |
| --- | --- |
| Patients presenting a malaise after the vaccination by any vaccine<br> | Drug: SARS-CoV-2 vaccine<br>* SARS-CoV-2 vaccination<br>|
| Patients presenting any other adverse event after the vaccination by any vaccine<br> | Drug: SARS-CoV-2 vaccine<br>* SARS-CoV-2 vaccination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disproportionality analysis in VigiBase® : search for an over-reporting of malaise with COVID-19 vaccines compared to influenza vaccines | case/no case study | from the 01/01/2021 to the 26/01/2022 |