linjc16/ctgov huggingface dataset:
The Effects of Inhaled Nitric Oxide After Fontan Operation

Study Overview
=================
Brief Summary
-----------------
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.

Official Title
-----------------
The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation

Conditions
-----------------
Congenital Heart Defect

Intervention / Treatment
-----------------
* Drug: inhaled nitric oxide (iNO)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female patients Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children Written parental permission to participate in this research study Exclusion Criteria: Any condition which the PI feels will interfere with the patient's safe and effective participation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 5 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention/ historical control group<br>historical controls group of patients who did not receive iNO. | |
| Experimental: Intervention<br>Prospective group who received iNO. | Drug: inhaled nitric oxide (iNO)<br>* Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.<br>* Other names: Inomax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Hospital Stay Following Fontan |  | until hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage | Percent of patients with significant pleural fluid collections that required thoracostomy drainage | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fontan
Risk Factors for Thrombosis in Children With Central Venous Lines

Study Overview
=================
Brief Summary
-----------------
This project addresses the role of lab markers around the time of central line placement in predicting risk of thrombosis in pediatric patients with central venous lines being placed. The project proposes an innovative way to predict higher risk of thrombosis in the pediatric population to give clinicians a valid tool to guide clinical practice for these patients.

Official Title
-----------------
Analysis of Laboratory Markers to Predict Risk of Catheter Related Thrombosis

Conditions
-----------------
Pediatric Venous Thromboembolism

Intervention / Treatment
-----------------
* Diagnostic Test: Labs drawn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 5 kg and less than 18 years of age. Patients having a central venous catheter or cardiac catheterization performed Exclusion Criteria: prior history of thrombosis patients with hemophilia A or B

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 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 |
| --- | --- |
| Central venous lines<br>Patients having a central venous catheter placed at Banner University Medical Center, University of Arizona | Diagnostic Test: Labs drawn<br>* We will collect blood samples/biomarkers at the time of enrollment.<br>|
| Cardiac catheterization<br>Patients undergoing a cardiac catheterization procedure done at Banner University Medical Center, University of Arizona | Diagnostic Test: Labs drawn<br>* We will collect blood samples/biomarkers at the time of enrollment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Patients will be enrolled during the time of central line placements and labs would be drawn during line placement. Patients will be followed prospectively for a catheter related t thrombosis event or not. Lab markers and clinical states of patients who develop or do not develop a thrombosis will be analyzed | within one year of enrollment |
High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients: a Comparative Study

Study Overview
=================
Brief Summary
-----------------
The investigators will investigate whether high-intensity exercise training can safely improve physical performance in long-term stable heart, kidney, lung, and liver transplant recipients. Adult transplant recipients will participate in Transplantoux, a 6-month individualized home- and group-based training program, with the goal to cycle the Mont Ventoux in France. The investigators will do cardiopulmonary exercise testing : maximal oxygen consumption, maximal power and BMI.

Official Title
-----------------
High-intensity Training Safely Improves Exercise Capacity in Heart, Lung, Kidney, and Liver Transplant Recipients

Conditions
-----------------
Physical Activity After Organ Transplantation

Intervention / Treatment
-----------------
* Other: High-intensity training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minimum post-transplant period of 6 months no acute rejection during the immediately preceding 6 months Exclusion Criteria: patients with cardiovascular or orthopedic contra-indications for intensive physical exercise

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: Training<br> | Other: High-intensity training<br>* 6-month individualized home- and group-based training program with the goal to cycle the Mont Ventoux in France<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max | Maximal oxygen consumption | 6 months after start training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical fitness, rehabilitation, maximum oxygen consumption, organ transplantation
Open Label Continuation Study of TRC105 for Patients Who Have Completed a Prior TRC105 Trial

Study Overview
=================
Brief Summary
-----------------
Open-label, continuation study

Detailed Description
-----------------
This is a multicenter, open-label, non-randomized, study of TRC105 in patients that have completed a previous TRC105 study and are judged by the investigator to have the potential to benefit from continued TRC105 therapy.

Official Title
-----------------
An Open Label Continuation Study of TRC105 Therapy for Patients Who Have Completed a Prior TRC105 Trial and Are Judged by the Investigator to Have the Potential to Benefit From Continued TRC105 Therapy

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: TRC105
* Drug: Bevacizumab
* Drug: Axitinib
* Drug: Pazopanib
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in a TRACON Pharmaceuticals sponsored parent TRC105 study and, thought to have potential to derive clinical benefit from continued treatment with TRC105 in the opinion of the parent study investigator. Willing and able to consent for self to participate in study Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 18 years of age or older ability to begin TRC105 dosing on this protocol within 6 weeks from the subjects last dose of TRC105 in the parent TRC105 study Exclusion Criteria: Any clinical event that would make TRC105 therapy inappropriate under the parent protocol Current treatment in another clinical study Pregnant or breastfeeding Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into the study

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

| Intervention/Treatment |
| --- |
|Drug: TRC105|nan|
|Drug: Bevacizumab|companion therapy selection depends on companion therapy used in the parent study|
|Drug: Axitinib|companion therapy selection depends on companion therapy used in the parent study|
|Drug: Pazopanib|companion therapy selection depends on companion therapy used in the parent study|
|Drug: Capecitabine|companion therapy selection depends on companion therapy used in the parent study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test

Study Overview
=================
Brief Summary
-----------------
The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect. The AcuVid COVID-19 Rapid Antigen Saliva Test performance will be compared to a high sensitivity FDA EUA approved RT-PCR COVID-19 test. Nasopharyngeal (for RT-PCR) swab results will be collected from subjects by healthcare providers at CLIA Waived COVID-19 Testing Centers, and on the same day the subjects will also provide saliva samples which will be tested and interpreted by the healthcare providers. This prospective, observational, study will test up to 300 participants to establish the performance characteristics of the AcuVid test on saliva specimens.

Official Title
-----------------
U.S. POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: AcuVid COVID-19 Rapid Antigen Saliva Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is willing to sign verbal informed consent form. Age ≥12 and parents or legal guardians must consent as required by law. Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab sample. Participant is willing to provide a self-collected saliva sample. Exclusion Criteria: Participant has previously tested positive for COVID-19 within the past 90 days.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: AcuVid COVID-19 Rapid Antigen Saliva Test|The AcuVid COVID-19 Rapid Antigen Saliva Test is a lateral flow immunoassay to detect SARS-CoV-2 nucleocapsid antigens in human saliva specimens|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test | To establish the performance characteristics of the AcuVid COVID-19 Rapid Antigen Saliva Test in a point-of-care (POC) CLIA Waived setting with lay users (no laboratory experience) testing a participant that has self-collected a saliva specimen. Clinical accuracy of the AcuVid Test will be compared to RT-PCR test results. Accuracy refers to the (PPA, positive percent agreement (sensitivity) and (NPA, negative percent agreement (specificity) between the results of the AcuVid Test and the comparator RT-PCR test. | 1 day |
Behavioral Counseling for Alcohol Dependent Smokers (Nicotine Patch)

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effectiveness of a mood management intervention on abstinent alcoholic smokers with a history of major depression. The second aim is to determine the effect of smoking treatments on alcohol abstinence and to identify factors associated with smoking and alcohol outcomes (e.g., more days of abstinence). A randomized, two-group design will be used to evaluate the added benefit of mood management compared to a state-of-the-art smoking cessation treatment. Treatment will consist of 8 weekly group sessions and 1, 3, 6, and 12-month follow-up.

Official Title
-----------------
Mood Management Training for Alcohol Dependent Smokers

Conditions
-----------------
Alcoholism, Smoking

Intervention / Treatment
-----------------
* Drug: nicotine replacement patch
* Behavioral: mood management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for alcohol dependence. Currently abstinent from alcohol and other drugs for at least 3 months. Meets criteria for history of major depression independent of alcohol use. Smoked an average of 10 or more cigarettes per day during the past month. Able to fully participate in all aspects of the study. Willing to participate in eight 2-hour treatment sessions and 12 months of followup. Willing to stop smoking and wear a nicotine patch for six consecutive weeks and refrain from participating in additional smoking interventions for the duration of treatment. Exclusion Criteria: Current episode of major depression (within the last 3 months) or current or lifetime history of bipolar disorder, schizophrenia or other major psychiatric disorders. Current use of antidepressant, other psychotropic medications, smokeless tobacco, nicotine replacement or other smoking cessation therapy. Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (within 1 month) of myocardial infarction or stroke, history of severe skin allergies or evidence of severe chronic dermatoses. Currently pregnant, breast feeding or likely to become pregnant during the nicotine patch phase of the study.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nicotine replacement patch|nan|
|Behavioral: mood management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Biodistribution of 1-[2 Deoxy-2, -18 Fluroarabinfuranosyl]Cytosine [18FAC] in Healthy Subjects and Patients With Cancer, Autoimmune/Inflammatory Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether positron emission tomography using the new imaging agent 18F-FAC can be used for imaging cancer and/or inflammation.

Official Title
-----------------
The Biodistribution of 1-[2 Deoxy-2, -18 Fluroarabinfuranosyl]Cytosine [18FAC] in Healthy Subjects and Patients With Cancer, Autoimmune/Inflammatory Diseases: A Pilot Study

Conditions
-----------------
Cancer, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age women of childbearing potential will undergo a pregnancy test free of charge patients with cancer or autoimmune diseases or healthy subjects

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 |
| --- | --- |
| patients with cancer<br> | |
| patients with autoimmune diseases<br> | |
| healthy subjects<br> | |

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
-----------------
18F-FAC, imaging, cancer, inflammation, PET
Impact of Maternal Supplementation With Dual Megadose of Vitamin A

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.

Detailed Description
-----------------
The effect will be assessed by the milk and blood.

Official Title
-----------------
Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months

Conditions
-----------------
Hypovitaminosis, Vitamin A Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: vitamin A
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant low-risk obstetric Exclusion Criteria: Premature birth Newborn babies with birth defects and / or other serious diseases
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: A<br>After birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of vitamin E will be administer. | Dietary Supplement: Placebo<br>* second capsule with vitamin E, eight days after delivery.<br>|
| Experimental: B<br>After birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of 200,000 UI of retinol palmitate (vitamin A)plus vitamin E will be administer. | Dietary Supplement: vitamin A<br>* second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seric retinol |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and growth of the child. |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypovitaminosis A
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Detailed Description
-----------------
Patients with severe aortic stenosis undergo aortic valve replacement (AVR). One approach to reduce trauma and operation time is the implantation of a sutureless valve to reduce aortic cross-clamp time due to the missing necessity of suturing the valve. Until now, sizing of the valve was determined intraoperatively using the measuring devices provided by the product manufacturer. Due to the implantation mechanism, the valve has to be collapsed after determination of the size. This is consuming time and can seriously delay the procedure. This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.

Official Title
-----------------
Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: Sorin Perceval ® Sutureless Valve (Sorin Group Italia Srl, 13040 Saluggia, Italy), available in different sizes (S 19-21mm, M 21-23mm, L 23-25mm, XL 25-27mm)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implantation of a Sorin Perceval ® sutureless valve availability of preoperative CT scan Exclusion Criteria: denial of consent missing preoperative CT scan bad quality of preoperative CT scan
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Sorin Perceval ® Sutureless Valve (Sorin Group Italia Srl, 13040 Saluggia, Italy), available in different sizes (S 19-21mm, M 21-23mm, L 23-25mm, XL 25-27mm)|Sizing of the valve by preoperative CT scan of the heart and comparison of this measurement with the standard procedure (Sizing intraoperatively using the measuring devices provided by the product manufacturer)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of aortic valve sizing by preoperative CT scan of the heart | accuracy of aortic valve sizing by preoperative CT scan of the heart in comparison with the standard procedure (Sizing intraoperatively using the measuring devices provided by the product manufacturer) | during surgery procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PERCEVAL® sutureless aortic valve prosthesis, aortic valve stenosis, aortic valve replacement, preoperative CT scan of the heart