linjc16/ctgov huggingface dataset:
Dynamics of the Immune Response to COVID-19 / Infection by SARS-CoV-2

Study Overview
=================
Brief Summary
-----------------
To evaluate host-immune biomarkers including TRAIL, IP-10, CRP and their computational integration for predicting COVID-19 and disease severity in patients with PCR-confirmed COVID-19.

Official Title
-----------------
The Dynamics of the Immune Response to Infection by SARS Coronavirus 2

Conditions
-----------------
COVID-19, SARS-CoV-2, Viral Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent confirmed infection with SARS-CoV-2 (except for the controls) Exclusion Criteria: n/a

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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 |
| --- | --- |
| COVID-19 patients<br> | |
| Healthy controls<br> | |
| Non-COVID-19 patients with respiratory tract infection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential expression of biomarkers between COVID-19 and controls | Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, as compared to control subjects. | up to 90 days | 
| Differential expression of biomarkers between severe and non-severe COVID-19 | Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19, who require more extensive medical intervention (i.e., exhibit severe symptoms), i.e. severe infection vs. non-severe infection | up to 90 days | 
| Correlation of biomarkers with disease severity | Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration for predicting disease severity in patients with COVID-19, where measures of severity include ICU admission, respiratory failure, mechanical ventilation, septic shock, non-respiratory organ failure, and mortality. | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers depending on therapy | Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without specific therapy. | up to 90 days | 
| Biomarkers depending on bacterial co-infection | Differential expression of TRAIL, IP-10, CRP, and their computational integration in subjects with COVID-19 with or without bacterial co-infection. | up to 90 days | 
| Correlation of biomarkers with viral load | Correlation between host-immune biomarkers including TRAIL, IP-10, CRP, and their computational integration with infectiousness, i.e. e.g. viral load. | up to 90 days |
A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized study in patients who have received prior 5-FU therapy for colorectal cancer. The objective of this trial is to establish a maximum tolerated dose of ALIMTA and irinotecan given in combination as well as to assess the safety and efficacy of this combination for patients with locally advanced or metastatic colorectal cancer. ALIMTA and irinotecan will be given every 21 days.

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: ALIMTA
* Drug: irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic diagnosis of locally or metastatic colorectal cancer Prior therapy with 5-FU for metastatic cancer Adequate bone marrow, liver and kidney function Exclusion Criteria: Pregnancy Breast feeding Inability to interrupt aspirin therapy Brain metastasis Patients who have been treated previously with ALIMTA or irinotecan

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALIMTA|nan|
|Drug: irinotecan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin

Study Overview
=================
Brief Summary
-----------------
This is a registry of patients with non ST segment elevation Myocardial Infarction (heart attack) and/or unstable acute coronary artery syndrome treated with a standardized protocol including Bivalirudin. Data will be collected on diagnosis, treatment and outcomes.

Official Title
-----------------
Single Center Registry of Non-STEMI Acute Coronary Syndrome Patients Treated With Bivalirudin

Conditions
-----------------
Non-STEMI Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Chest pain or symptoms believed to be an anginal equivalent and representing myocardial ischemia, lasting at least 10 minutes within the past 24 hours Having any one of the following: Ischemic changes on ECG: ST depression >0.5 mm OR T wave inversion >2 mm Positive cardiac markers New onset CHF presumed secondary to ischemia Pulmonary edema Known coronary artery disease with typical symptoms Hemodynamic instability Sustained ventricular tachycardia Exclusion Criteria: For the purpose of the SSDI, patients will be excluded if we are unable to obtain their Social Security Number.

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 |
| --- | --- |
| Non-STEMI ACS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of MACE defined as any one of the following: • Acute myocardial infarction/reinfarction • Ischemia-driven unplanned revascularizations • Stroke • All cause Mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization for ACS |  | 30 days | 
| All cause mortality |  | 30 days, one year and up to 5 years | 
| Major Bleeding |  | in hospital and at 30 days |
Efficiency of a Telemedicine-based Follow-up on for the Medical Management of Patients Leaving the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Patients surviving to a stay in intensive care unit (ICU) are likely to require specific care and follow-up after their ICU stay, in order to manage the serious illness at the origin of the ICU stay and any sequelae, but also to adapt the treatments and prevent new complications. At present, there is no specific care chain after ICU. In order to meet this need, we propose the implementation of a care chain integrating telemedicine at home. We compare the current system (lack of specific follow-up) to follow-up by telemedicine at home.

Official Title
-----------------
Efficiency of a Telemedicine-based Follow-up on for the Medical Management of Patients Leaving the Intensive Care Unit

Conditions
-----------------
Care After Going to Intensive Care

Intervention / Treatment
-----------------
* Device: Monitoring by Tele-Medecine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient ≥ 18 years old Patient admitted to ICU Stay in intensive care > 48h Patient having benefited from at least one organ support during the ICU stay: invasive or non-invasive ventilation (including nasal high-flow oxygen therapy), inotropic or vasopressor support, renal replacement therapy) Understanding of the French language Patient or entourage able to carry out the measures proposed by telemedicine Subject affiliated to a social health insurance scheme Subject having signed a consent form Exclusion criteria: Subject under guardianship or curatorship Pregnancy / lactation Voluntary drug poisoning

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 |
| --- | --- |
| No Intervention: Control<br>Standard of care | |
| Experimental: Tele-Medecine<br>The experimental group will be given a case of connected devices dedicated to telemedicine allowing them to closely monitor their state of health during the 3 months following discharge from hospital | Device: Monitoring by Tele-Medecine<br>* Monitoring by Tele-Medecine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the medico-economic of telemedicine monitoring | The main judgment criterion will be the incremental cost-utility ratio of the innovation represented by monitoring by a telemedicine device linked to a nurse coordination unit, compared to the usual monitoring without telemedicine. | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tele-medicine, Intensive Care Unit
PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to demonstrate the safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Detailed Description
-----------------
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.

Official Title
-----------------
The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Conditions
-----------------
Patent Foramen Ovale

Intervention / Treatment
-----------------
* Device: PFx catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65 years old Documented PFO Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness Exclusion Criteria: • Inappropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: PFx catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFO closure 6 months post procedure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFO closure at 30 days and 12 months post procedure |  | 30 days, 12 months | 
| AE event rates for all subjects |  | 30 days, 6 and 12 months | 
| Migraine severity |  | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PFO, Migraine, Stroke, TIA (transient ischemic attack), Decompression Illness
The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit

Study Overview
=================
Brief Summary
-----------------
We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

Detailed Description
-----------------
While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population

Official Title
-----------------
No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.

Conditions
-----------------
Sepsis, Respiratory Failure, Renal Failure, Surgical Site Infection

Intervention / Treatment
-----------------
* Drug: Novolin R (human recombinant Insulin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability - Exclusion Criteria: Under age 18

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Novolin R (human recombinant Insulin)|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU Stay |  |  | 
| Ventilatory Requirement |  |  | 
| Vasopressor Support |  |  | 
| Incidence of Renal Failure |  |  | 
| Incidence of Wound Infection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intensive Insulin Therapy, General Surgical, Vascular Surgical, Tight Glycemic Control
Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.

Official Title
-----------------
A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

Conditions
-----------------
Graft vs Host Disease, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil, methotrexate, cyclosporin
* Drug: Methotrexate and cyclosporin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling Exclusion Criteria: known allergy to mycophenolate mofetil

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

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

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

| Intervention/Treatment |
| --- |
|Drug: mycophenolate mofetil, methotrexate, cyclosporin|nan|
|Drug: Methotrexate and cyclosporin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute GVHD incidence and grading |  | 100 Days | 
| chronic GVHD incidence |  | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality, GVHD-related and all cause |  | 3 Years | 
| Symptomatic side effects attributed to MMF |  | 60 Days | 
| Date of engraftment |  | Date of engraftment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute graft-versus-host disease post high risk allogeneic stem cell transplantation
Unboosted Atazanavir as Initial ART Therapy in China

Study Overview
=================
Brief Summary
-----------------
This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese resource-limited setting.

Conditions
-----------------
Antiretroviral Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent The subject should have established HIV infection more than 6 month. Qualifying plasma HIV RNA ≥ 2,000 c/mL and a CD4 cell count within 100 - 350 cells/mm3 ≥16 years of age Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized. Exclusion Criteria: Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. History of hemophilia Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are < 3 times the upper limit of normal. Presence of cardiomyopathy. A history of arrhythmia or clinical symptoms potentially related to heart block or second / third degree heart block. Inability to tolerate oral medication Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acquired Immunodeficiency Syndrome, antiretroviral therapy, China
Fast Assay for Pathogen Identification and Characterization - Prospective Study

Study Overview
=================
Brief Summary
-----------------
The FAPIC project will develop a diagnostic system that will identify pathogens and charachterize virulence and resistance. A prospective study will be performed in which blood samples will be collected of patients with suspected sepsis in order to evaluate the diagnostic system. In routine care, blood is drawn of these patients for culture in order to identify the causative pathogen. This process takes 3-5 days. During the study, one extra blood sample will be collected with the same venipuncture, with each blood culture. Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the research laboratories for determination of sensitivity and specificity. The system will not be used in the clinic.

Official Title
-----------------
Fast Assay for Pathogen Identification and Characterization - Prospective Study

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years Suspicion of bacteremia Exclusion Criteria: Children (<18 years)

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

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 |
| --- | --- | --- |
| Detection of pathogens and its virulence factors and susceptibility genes | Sensitivity, specificity, and accuracy of the molecular system compared to blood culture. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population outcome during routine procedures | Insights on routine hospital procedures using blood culture and outcomes on the study population such as TAT, antimicrobial use, time to antimicrobial change, in-hospital stay, and mortality by collection of patient data in the medical records. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Molecular diagnosis, Pathogen identification, Sepsis, Bacteremia, Rapid diagnostics