linjc16/ctgov huggingface dataset:
Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock

Study Overview
=================
Brief Summary
-----------------
Septic shock is the most severe form of a bacterial infection, affecting 24 million patients per year worldwide, with a high mortality (> 30%). Septic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood. Therefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock. Thus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects. Concerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo

Official Title
-----------------
Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Other: 3-time blood sampling for septic shock patients
* Other: Only one blood sampling for controls patients


Participation Criteria
=================
Eligibility Criteria
-----------------
For all subjects Age > 18 years old For females: negative pregnancy test Subject covered by health insurance Written consent Patients with septic shock Patients must be in ICU Septic shock defined by the Sepsis-3 criteria [1] Inclusion within the 12 hours following the onset of norepinephrin Controls : Blood donors Exclusion criteria: Moribund Age < 18 years old Absence of written consent

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 |
| --- | --- |
| Patient in septic shock<br> | Other: 3-time blood sampling for septic shock patients<br>* 15 mL blood are sampled at day1, day 3 and day 7, from the arterial catheter inserted for all patients with septic shock<br>|
| blood donor tests<br> | Other: Only one blood sampling for controls patients<br>* 15 mL blood are sampled from a blood donation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of the activated interferon-α receptors (IFNAR) by circulant endothelial cells |  | Within 12 hours following the onset of norepinephrin for septic shock (day 1) |
Modified Consent Form Utility

Study Overview
=================
Brief Summary
-----------------
Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than the standard document. The hypothesis is that using a shorter form that is more easily understood and more visually simple will lead to greater subject satisfaction in the consent process and will not compromise subject comprehension of key study aspects. Consent for study inclusion has been waived by the IRB because informing subjects of the nature and process of the study would likely affect the findings, and both the standard and modified consent forms were approved for use in the nutrition study.

Official Title
-----------------
CTSA Utility of Modified Consent Forms in Clinical Research: Fraga Tea Study

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

Intervention / Treatment
-----------------
* Other: Modified consent form
* Other: Standard consent form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation in parent study, English speaking Exclusion Criteria: none

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Modified consent form | Other: Modified consent form<br>* modified consent form used<br>|
| Active Comparator: 2<br>Standard consent form | Other: Standard consent form<br>* standard consent form used<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction |  | close of parent study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
informed consent document, ethics
Safety Evaluation of Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Propofol is often used for sedation in children undergoing magnetic resonance imaging. The investigators will perform a chart review of 4 month of activity (about 100 cases) and review the incidence and severity of adverse events of this sedation technique.

Detailed Description
-----------------
Magnetic resonance imaging in children, especially under 6 years of age, is often performed under sedation. Propofol is a common drug used in this settings. In our institution, sedation is most often done by a propofol bolus of 2-5 mg/kg in order to reach a deep level of sedation as defined by Coté et al. If judged necessary by the attending anaesthesiologist, a additional propofol bolus of 0.5-1 mg/kg may be given. For longer lasting exams, the attending anaesthesiologist can chose to use a continuous infusion of propofol. The investigators will review the charts of 4 month of magnetic resonance imaging, which will give us a cohort of about 100 patients. Baseline characteristics, detailed sedation technique used will be recorded. Adverse events defined as: Oxygen desaturation measured by transcutaneous oximetry SpO2≤94% hypercapnia measure by end-tidal CO2 >45 mm Hg movement of the patient Assuming a non-normal distribution (tested by a Kolmogorov-Smirnov test), variables will be reported as median and interquartile range. Statistical tests will be done by non-parametric tests, Mann Whitney U. Non continuous variables will be analyzed by a Chi-square test.

Official Title
-----------------
Incidence of Adverse Events During Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients

Conditions
-----------------
Multiparametric Magnetic Resonance Imaging, Propofol Adverse Reaction, Sedation Complication, Anesthesia; Adverse Effect

Intervention / Treatment
-----------------
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients scheduled for MRI under sedation by an anaesthesiologist Age < 16 years Exclusion Criteria: Age > 16 years Sedation performed by a non-anesthesiologist

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propofol|Sedation by propofol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | Arterial desaturation defined as number of episodes with an SpO2≤94% | 90 minutes | 
| Hypercapnia | Hypercapnia, defined as number of episodes with an ETCO2 > 45 mm HG | 90 minutes | 
| Movements | Number of patient movements interfering with the MRI exam | 90 minutes |
Evaluation of Synchrony in the Post-operative Patient

Study Overview
=================
Brief Summary
-----------------
Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient. This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.

Official Title
-----------------
Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)

Conditions
-----------------
Patient-ventilator Asynchronism

Intervention / Treatment
-----------------
* Device: MAQUET SERVOi ventilator with Edi Catheter
* Device: MAQUET SERVOi ventilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult > 18 yr-old abdominal post-operative patient able to trigger the ventilator Exclusion Criteria: infant pregnancy esophageal surgery recent esophageal variceal bleeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Pressure support<br> | Device: MAQUET SERVOi ventilator<br>* Pressure Support<br>* Other names: Pressure Support;|
| Experimental: NAVA<br> | Device: MAQUET SERVOi ventilator with Edi Catheter<br>* NAVA respiratory modality<br>* Other names: Neurally Adjusted Ventilatory Assist;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchrony index (AI) | Number of asynchrony events/total respiratory rate | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio | ratio of partial pressure arterial oxygen and fraction of inspired oxygen | 8 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAVA, post operative
Endourological Management of Stones During COVID19

Study Overview
=================
Brief Summary
-----------------
Guidelines for endourological procedures during COVID-19 have suggested deferring all elective procedures, while obstructed/ infected stones should undergo urgent decompression. At our centre, screening protocols were implemented with prioritization strategies so that elective care could safely continue at deescalated rates. COVID or septic patients underwent emergency decompression, while non-COVID and non-septic patients underwent primary ureteroscopy (URS) or retrograde intrarenal surgery (RIRS). We aim to report our experience with endourological surgery for stone disease during COVID-19.

Detailed Description
-----------------
We conducted a retrospective review of a prospectively maintained database of all endourological surgeries for stones in our centre during the first wave of COVID19.

Official Title
-----------------
Definitive Endourological Interventions for Urolithiasis Management During COVID19- Outcomes From a Cohort Study

Conditions
-----------------
Urolithiasis, COVID-19

Intervention / Treatment
-----------------
* Procedure: Endourological surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria - all patient with urolithiasis who underwent endourological interventions during COVID19 pandemic
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who underwent endourological surgery for urolithiasis during COVID19<br>Endourological surgery (including ureteral stent insertion, ureteroscopy, retrograde intrarenal surgery) | Procedure: Endourological surgery<br>* Includes ureteral stent insertion, ureteroscopies and retrograde intrarenal surgeies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of hospital stay | From admission to discharge from hospital, up to 3 months | 
| Complication rate | Complications as defined by Clavien Dindo classification system | From admission up to 3 months post operatively | 
| Stone free rate |  | At follow up visit in clinic 3 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate |  | From discharge up to three months post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endourology, pandemic
Data Collection With the P200TE and P200TxE

Study Overview
=================
Brief Summary
-----------------
The primary objective is to collect OCT scans on a modified P200TxE and P200TE.

Official Title
-----------------
Data Collection With the P200TE and P200TxE in Diseased Eyes for Clinical Developments

Conditions
-----------------
Retinal Disease

Intervention / Treatment
-----------------
* Device: Imaging Session


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Male or female volunteers 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed; Volunteers who can follow the instructions by the clinical staff at the clinical site; Volunteers who agree to participate; Volunteers who have been diagnosed with retina pathology with intra-retinal and/or subretinal fluid present in the posterior pole region. Exclusion Criteria: Volunteers unable to tolerate ophthalmic imaging; Volunteers with ocular media not sufficiently clear to obtain acceptable OCT images.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P200TxE Device First<br> | Device: Imaging Session<br>* Various scans will be captured on both devices<br>|
| Experimental: P200TE Device First<br> | Device: Imaging Session<br>* Various scans will be captured on both devices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of images | The primary endpoint will be the collection of OCT scans on the P200TE and P200TxE devices. The scans will be used by R&D for development of a de-noising algorithm as well as other possible developments. | 1 year |
Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS

Study Overview
=================
Brief Summary
-----------------
The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS).

Detailed Description
-----------------
We included 83 patients receiving TIPS for prevention of rebleeding, therapy-refractory ascites or both. Hemodynamic parameters were assessed before TIPS and after TIPS insertion. 16 patients from Freiburg underwent TE immediately before and after TIPS. In 67 patients from Bonn, SWE of liver and spleen, as well as clinical and biochemical parameters were assessed before TIPS, seven days and six weeks after TIPS.

Official Title
-----------------
Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS

Conditions
-----------------
Portal Hypertension, Liver Cirrhoses

Intervention / Treatment
-----------------
* Diagnostic Test: Stiffness measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TIPS insertion and had reliable SWE or TE measurement Exclusion Criteria: contraindication for TIPS no reliable SWE or TE measurement

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>receiving TE before and 30 min after TIPS | Diagnostic Test: Stiffness measurement<br>* Transient Elastopgraphy (TE) or Shear-Wave-Elastography<br>|
| 2<br>receiving SWE before and 7 days, 6 weeks and 3 months after TIPS | Diagnostic Test: Stiffness measurement<br>* Transient Elastopgraphy (TE) or Shear-Wave-Elastography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute-on-chronic Lvier failure |  | 3 months |
Nighttime Communication Study

Study Overview
=================
Brief Summary
-----------------
This study seeks to determine whether a family-centered nighttime communication intervention improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of nighttime medical care.

Official Title
-----------------
The Effect of a Family-Centered Nighttime Communication Bundle on Shared Mental-Model Building, Safety, and Patient Experience

Conditions
-----------------
Communication

Intervention / Treatment
-----------------
* Behavioral: Family-centered nighttime communication bundle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of patients admitted to the general pediatrics inpatient units Overnight nurses working on the general pediatrics inpatient units Overnight residents working on the general pediatrics inpatient units Exclusion Criteria: Non-English speaking parents
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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-nighttime communication intervention arm<br>This arm is the pre-intervention arm of parents, nurses, and residents before the nighttime communication bundle has been enacted. | |
| Experimental: Post-nighttime communication intervention arm<br>This arm is the post-intervention arm of parents, nurses, and residents after the nighttime communication bundle has been enacted. | Behavioral: Family-centered nighttime communication bundle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between parent, resident, and nurse reported elements of the patient action plan and overall plan | This will be assessed through surveys administered to parents, residents, and nurses for a subset of patients every evening. Parent, resident, and nurse responses will be compared pre and post-intervention. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-reported medical errors | This will be assessed through surveys administered to parents for a subset of patients every evening. Parent error reporting will be compared pre and post-intervention. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, patient experience, family-centered rounds
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
To make belatacept available for recipients of a renal allograft who are currently intolerant to or have contraindications to CNIs and/or m-TOR inhibitors and are either: unable to construct an adequate immunosuppression regimen due to nonrenal toxicity / contraindication (and withdrawing the causative agent would lead to renal graft loss) OR at imminent risk of losing the allograft kidney due to nephrotoxicity and have no other options for renal replacement therapy

Official Title
-----------------
Belatacept for Renal Allograft Recipients: A Compassionate Use Program

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Belatacept


Participation Criteria
=================
Eligibility Criteria
-----------------
Please call 800-398-9157 for information on this study Inclusion Criteria: Men and women of age 18 years or older inclusive Recipient of a renal allograft for at least ≥ 2 months EBV positive Unable to tolerate a suitable immunosuppression regimen to prevent acute allograft rejection, due to: Extra-renal toxicity related to CNIs and/or m-TOR inhibitors that is refractory to medical management (eg, uncontrolled seizures) Contraindication to CNIs and/or m-TOR inhibitors OR At imminent risk of losing allograft kidney due to nephrotoxicity Renal failure: ≥ Stage 4 on KDOQI Scale (GFR 15 - 29 cc/min) And no other renal replacement therapy Subjects must be receiving the maintenance immunosuppressants MMF, MPA, or AZA Exclusion Criteria: Any significant infection, extra-renal solid organ (heart, liver, pancreas) or cell (islet, bone marrow, stem cell) transplants, with an unresolved episode of AR within the last 6 weeks EBV negative

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Belatacept|IV, 5 mg/kg, once monthly, until BMS terminates trial or Belatacept is available commercially|

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

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