linjc16/ctgov huggingface dataset:
Circulating microRNAs as Biomarkers of Sepsis

Study Overview
=================
Brief Summary
-----------------
MicroRNA has been demonstrated to play a crucial role in regulating cell processes. Recently, microRNA was identified to exist in human serum or plasma, and it might be related to certain diseases. Several microRNAs are involved in sepsis, such as miR-146, miR-155, and so on. But whether serum miR-146 is present in serum of septic patients remains unknown. The present study was designed to identify the existence of specific microRNAs, which might be new markers for sepsis and its prognosis.

Official Title
-----------------
Diagnostic and Predictive Value of Circulating microRNAs During Sepsis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who develop sepsis and undergo abdominal surgery patients who develop SIRS after cardiac surgery with cardiopulmonary bypass Exclusion Criteria: patients with a primary diagnosis of acute pancreatitis patients with cirrhosis or renal dysfunction patients with dyscrasia patients with autoimmunity diseases patients with severe cardiac and pulmonary diseases patients with hematological diseases patients who had organ dysfunction after cardiac surgery with cardiopulmonary bypass

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sepsis group<br>Patients who develop sepsis in the ICU | |
| SIRS group<br>Patients who develop SIRS after cardiac surgery with cardiopulmonary bypass | |
| control group<br>normal healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative amount of circulating microRNAs |  | On the second day of diagnosis of sepsis in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of CRP and IL-6 |  | On the second day of diagnosing sepsis | 
| Apache II score and death |  | On the second day of diagnosis of sepsis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, microRNA
Trial of Two Central Venous Catheter (CVC) Flushing Schemes in Pediatric Hematology and Oncology Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether flushing Central Venous Catheters (CVCs) with Normal saline once per week is not inferior to flushing with 10U/ml heparin 3 times per week, in preventing CVC occlusions.

Detailed Description
-----------------
Tunneled central venous catheters (CVCs) are now used routinely in pediatric hematology and oncology patients. Flushing with heparin solution is routinely recommended to prevent occlusion of long term CVCs, although the concentration of heparin used, and frequency of its use varies between centres. Once weekly Normal saline is also used successfully in some pediatric enters. There is little evidence to support one method over the other. The investigators have designed a randomised crossover trial to directly compare once weekly Normal saline flushing with 3 times per week 10U/ml heparin flushing, to determine whether Normal saline is not inferior to heparin.

Official Title
-----------------
A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada

Conditions
-----------------
Childhood Cancer, Aplastic Anemia, Metabolic Disorders

Intervention / Treatment
-----------------
* Drug: Heparin
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosis of any malignant or nonmalignant disease that requires a single lumen Broviac or double lumen Hickman-type CVC for the purpose of chemotherapy, blood product support or hematopoietic stem cell transplantation. CVC is planned to remain in situ for 6 months from study entry Exclusion Criteria: Thrombophilia (e.g. Factor V Leiden mutation, antiphospholipid syndrome) or previous thrombosis requiring anticoagulation (e.g. enoxaparin, unfractionated heparin) Bleeding disorder (e.g. von Willebrand's disease, hemophilia) Previous CVC that was removed due to any complication

Ages Eligible for Study
-----------------
Maximum Age: 17 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10U/l heparin<br> | Drug: Heparin<br>* 5ml 10 units/ml IV heparin 3 times per week<br>|
| Experimental: normal saline<br> | Drug: Normal saline<br>* 10ml normal saline IV weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | 6 months |
SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction

Study Overview
=================
Brief Summary
-----------------
The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body. The SeriACL device is designed to be installed with standard surgical techniques for ACL repair. This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.

Official Title
-----------------
A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair

Conditions
-----------------
Anterior Cruciate Ligament, Knee Injuries

Intervention / Treatment
-----------------
* Device: ACL Reconstruction (SeriACL™ Device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete ACL rupture Injured knee range of motion >= 75% of contralateral knee MCL tear grading <= 2 Sign informed consent. Exclusion criteria: Prior ACL reconstruction Complete PCL tear Locked bucket handle tear or complex tears of the menisci. Contralateral knee ligament injury Known joint disease Known allergy to silk Active drug or alcohol abuse Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Intervention/Treatment |
| --- |
|Device: ACL Reconstruction (SeriACL™ Device)|Bioresorbable ACL|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - measured by device related SAEs |  | 12 months | 
| KT-1000 Arthrometer |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Surveys |  | 12 months | 
| Return to Work |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACL, ligament, ACL injury
Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a relationship exists between a previously established diagnosis of endometriosis and the consecutive risk of developing a clear cell or endometrioid ovarian carcinoma. All histopathological records since 1980 with these diagnoses (endometriosis, clear cell and endometrioid ovarian carcinoma) will be reviewed. Cancer registry data will be assessed to investigate differences in survival of women with endometriosis-associated ovarian carcinomas and those ovarian carcinoma patients without previous diagnosis of endometriosis.

Official Title
-----------------
Endometriosis and Frequency of Endometriosis-associated Ovarian Carcinomas (EAOC) - Epidemiological and Molecular Pathological Aspects

Conditions
-----------------
Endometrioid Carcinoma, Clear Cell Carcinoma, Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: endometrioid ovarian carcinoma clear cell ovarian carcinoma endometriosis, atypical endometriosis borderline tumors with endometriosis Exclusion Criteria: undifferentiated carcinomas germ cell tumors sex cord-stromal tumors

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

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

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 |
| --- | --- | --- |
| incidence and clinical outcome of endometriosis-associated ovarian carcinomas |  | 30 years |
Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support

Study Overview
=================
Brief Summary
-----------------
Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron repletion in fewer doses (2) when compared with other available injectable iron formulations (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is common in patients after placement of a ventricular assist device (VAD) for treatment of end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency after placement of a VAD.

Official Title
-----------------
Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Ferumoxytol injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Status post placement of durable ventricular assist device with stable clinical status for >30days Hemoglobin >6 g/dL AND <13 g/dL (men) or <12 g/dL (women) within last 90 days Serum ferritin <100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation <20% within last 90 days Able and willing to provide written informed consent Exclusion Criteria: Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation History of anaphylaxis Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months Renal failure on hemodialysis Respiratory failure on mechanical ventilation Disabling Stroke Ventricular assist device thrombosis Evidence of active gastrointestinal bleeding or other active blood loss Hospitalization <30 days Pregnant or breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 110 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: Ferumoxytol injection treatment<br> | Drug: Ferumoxytol injection<br>* Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment |  | Month 6 |
To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, controlled, observational study. 150 nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation will be enrolled as subjects in the two groups is 1:1. In the experimental group, vaginal examination will be performed at 39 to 40 weeks to assess cervical conditions. If the bishop score <6, the balloon catheter combined with oxytocin induction will be planned at 40 weeks ±3 days. In the control group, one week to 41 weeks ±3 days will be expected. Vaginal examination will be performed again to evaluate cervical conditions. If the bishop score <6 points, and balloon catheter combined with oxytocin induction will be performed. After 96h, their final delivery mode will be recorded. In the following 42 days postpartum, their complications and the neonatal outcome will be followed up.

Official Title
-----------------
To Evaluate the Efficacy and Safety of Balloon Catheter Combined With Oxytocin Induction in Nulliparous Women With Estimated Fetal Weight ≥3500g at 39-40 Weeks of Gestation: a Randomized, Controlled, Observational Study

Conditions
-----------------
Macrosomia, Fetal

Intervention / Treatment
-----------------
* Procedure: balloon catheter combined with oxytocin induction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton head position pregnancy, negative Down's screening and /or NIPT screening, no malformation was found, with slight/without pregnancy complications - Exclusion Criteria:twin or multiple pregnancy, scar uterus, with contraindications to vaginal delivery, estimated fetal weight >4500g -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nulliparous women with estimated fetal weight ≥3500g at 39-40 weeks of gestation<br> | Procedure: balloon catheter combined with oxytocin induction<br>* Balloon catheter for 12 hours and oxytocin for up to 3days.If failed , they will be treated ceacrean.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaginal birth rate | After spontaneous labor for up tp 24 hous, the mode of delivery will be konwn and recorded. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
balloon catheter, oxytocin
Ublituximab + Ibrutinib in Select B-cell Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with Ibrutinib in patients with advanced hematologic malignancies.

Official Title
-----------------
A Multi-center Phase II Study With Safety Run-in Evaluating the Efficacy and Safety of Ublituximab in Combination With Ibrutinib in Patients With Select B-Cell Malignancies

Conditions
-----------------
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: Ublituximab
* Drug: Ibrutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed Mantle Cell lymphoma (MCL) open for enrollment. The Chronic Lymphocytic Leukemia (CLL) enrollment arm is now closed. Refractory to or relapsed after at least 1 prior treatment regimen Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: Any major surgery, chemotherapy or immunotherapy within the last 21 days Known hepatitis B virus, hepatitis C virus or HIV infection Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded. Richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ublituximab + ibrutinib<br>Ublituximab: IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Ibrutinib: Fixed oral daily dose | Drug: Ublituximab<br>* Ublituximab (IV infusion)<br>Drug: Ibrutinib<br>* Ibrutinib oral daily dose<br>* Other names: Ibrutinib (IMBRUVICA);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of ublituximab in combination with ibrutinib in patients with select B-cell malignancies | To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities | 28 days (1 cycle of therapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with Ibrutinib | Up to 1 year |
Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.

Conditions
-----------------
Myocardial Injury

Intervention / Treatment
-----------------
* Drug: HTK solution
* Drug: crystalloid cardioplegia solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective pediatric cardiac surgery Patients written informed consent for study participation Exclusion Criteria: redo surgery allergy to study drugs unstable blood pressure before cardiac surgery

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 6 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: crystalloid cardioplegia solution<br>After aortic cross clamp 30ml/kg will be administered | Drug: crystalloid cardioplegia solution<br>* 30 ml/kg bolus in two minutes<br>|
| Active Comparator: HTK solution<br>After aortic cross clamp 50ml/kg will be administered | Drug: HTK solution<br>* 50 ml/kg bolus in 2 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial protective effect of HTK solution | to detect %33 difference in Troponin-I levels 4 hours postoperatively | postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic and respiratory data | arterial pressures, heart rate,blood gas analysis | postoperative 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTk solution, Cardioplegia, myocardial protection, pediatric cardiac surgery