cyrilzakka/clinical-trials huggingface dataset:
Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism (VTE) Events

The study will evaluate the effectiveness of a novel, real-time risk prediction model for identifying pediatric patients at risk for developing in-hospital blood clots (or venous thromboembolism \[VTE\]) based on data easily extracted from the electronic medical record. The study will assess whether using the risk percentages for developing VTE derived from the model increases the number of high-risk patients screened by the pediatric hematology team, which may may lead to an overall reduction in the number of pediatric VTEs seen at Monroe Carell Jr. Children's Hospital at Vanderbilt.

VTE risk factors in adult hospitalized patients are well established and prevention strategies have been implemented for many years. Unfortunately, VTE prevention guidelines are not well established in children, and the pathophysiology of pediatric VTE is sufficiently different from adults that adult studies cannot be extrapolated to pediatrics. There are no randomized trials in pediatrics to determine whether a risk prediction model helps prevent pediatric VTEs.

A risk prediction model was developed that can be applied at admission and updated daily to predict pediatric patients at higher risk for developing a VTE. This model was developed from electronically extracted data from all admissions to the Monroe Carell Jr. Children's Hospital at Vanderbilt from January 1, 2010 to October 31, 2017. Cases were identified based on ICD-9/10 codes. Potential covariates were identified from previous studies and known risk factors for VTE development. The variables with the highest adjusted odds ratio (OR) for developing VTE were history of thrombosis (OR 8.7, 95% confidence interval (CI) 6.6-11.3, p\<0.01), presence of a central venous line (OR 4.9, 95%CI 4.0-5.8, p\<0.01), and cardiology consultation (OR 4.0, 95%CI 3.3-4.8, p\<0.01). Additional significant variables include whether a blood gas was performed, infectious disease consultation, diagnosis of cancer, age, mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), lactate, and whether surgery was performed.

There have been several smaller pediatric VTE risk prediction models that have been developed and published. However, none of these have been evaluated for efficacy in a prospective trial, and none of these studies have used a randomized trial approach to evaluate benefit in identifying pediatric patients at high risk for developing VTE. Therefore, the investigators are performing a randomized, pragmatic trial to evaluate the pediatric VTE risk prediction model and its efficacy at predicting pediatric patients at higher risk for developing a VTE.

Eligibility Criteria:
Inclusion Criteria:

1. All pediatric patients 0-21 years of age who are admitted to an inpatient unit of Monroe Carell Jr. Children's Hospital at Vanderbilt will be included in the study.

Exclusion Criteria:

1. Receiving prophylactic or therapeutic dosing of anticoagulants, including enoxaparin, warfarin, bivalirudin, apixaban, rivaroxaban, dabigatran, and edoxaban.
2. Patients admitted under "observation status"
Comparing a Direct Versus an Indirect Approach to Measuring the Portalsytemic Pressure Gradients

The objective of this study is to evaluate the correlation of the calculated portosystemic pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with the EchoTip® Insight™ and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis who have been referred for a procedure where HVPG is obtained.

Exclusion Criteria:

* Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
* Patient is unwilling or unable to sign and date the informed consent
* Patient is unwilling to comply with the follow-up study schedule
* Previous total or partial splenectomy
* Non-cirrhotic portal hypertension
* Known history of spontaneous bacterial peritonitis (SBP) within the last three months irrespective of treatment for SBP
* Patients with known infection which is not controlled by medical intervention
* Portopulmonary hypertension
* Cardiac decompensation
* Pre-sinusoidal liver disease
* Cholestatic liver disease
* Patient who received endoscopic treatment for upper gastrointestinal (GI) variceal bleeding within the past 7 days
* Patients with current hepatocellular carcinoma (HCC)
A Study Of The Taste Of Different Oral Liquid Preparations Of CP-690,550 In Trained Adult Product Testers

This study will test the palatability of several different CP-690,550 oral preparations in trained product tester healthy volunteers.

To develop a palatable pediatric oral solution dosage form of CP-690,550.

Eligibility Criteria:
Inclusion Criteria:

* Trained healthy non-pregnant product testers, age 18-75

Exclusion Criteria:

* Severe acute or chronic medical conditions, including hepatitis or tuberculosis infections or clinically significant laboratory abnormalities.
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea

Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.

Assessment of safety after repeated skin application.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate papulopustular rosacea
* free of any clinically significant disease

Exclusion Criteria:

* body weight less than 50 or more than 130 kg
* clinically significant disease which could interfere with the study
A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease

Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical records.

This is a non-interventional, retrospective study of participants with CD and CPF in a clinical practice setting.

The study will enroll approximately 100 participants.

The study will have a retrospective data collection to select and analyze information from EMRs processed by an AI based analytics framework that uses machine learning and NLP methodologies.

All participants will be enrolled in one observational group.

• Participants with CD

This multi-center trial will be conducted in Spain. The overall duration of the study is approximately 36 months.

Eligibility Criteria:
Inclusion Criteria:

1. CD participant diagnosed or not with CPF between January 1st 2015 and December 31st 2021.

Exclusion Criteria:

Not applicable.
Expanded Access Protocol Using HBOC-201

The purpose of this protocol is to provide treatment with HBOC-201 to patients with life-threatening anemia for whom allogeneic blood transfusion is not an option. HBOC 201 \[hemoglobin glutamer - 250 (bovine)\] has been previously studied as an alternative to blood transfusions in severely anemic patients needing a way to enhance tissue oxygenation. HBOC-201 is purified, cross-linked and polymerized acellular bovine hemoglobin in a modified lactated Ringer's solution, and does not require blood compatibility.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Critically ill patients with hemoglobin ≤ 6 g/dL (or 7-8 g/dL with significant active bleeding), and physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or evidence of central nervous system acute deficits
3. Patients or their Legally Authorized Representative who are able and willing to provide informed consent
4. Blood is not an option due to:

   * refusal of transfusion
   * lack of compatible red blood cells

Exclusion Criteria:

1. Patients with known hypersensitivity or allergy to beef products
2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis\*
3. Patients who are eligible for blood transfusions
4. Patients who are \> 80 years old\*

   * on a case by case and quality of life determination
Cardiac Effects From Radiation Therapy by MRI

The investigators will identify 10 patients in the department of radiation oncology who will receive standard of-care radiation therapy, and the treating radiation oncologist anticipates a mean left ventricular dose of at least 5 Gy. Patients will be evaluated by CMRI before and within one week of the completion of RT. We will compare the pre- and post-RT CMRI scans to identify changes related to radiation exposure. Our primary endpoint will be changes in myocardial strain. Secondary endpoints will include other CMRI parameters.

Cardiac toxicity is a significant cause of morbidity and mortality in cancer survivors after radiation therapy (RT) to the chest. Typically, cardiotoxicity is identified years after radiation exposure. Emerging clinical data show that subclinical injury can be identified immediately after treatment. Early identification of subclinical injury may enable intervention to reduce the risk of progression to clinically significant toxicity. The investigators hypothesize that cardiac magnetic resonance imaging (CMRI) will detect early cardiac injury after RT and that imaging changes will be associated regionally with cardiac radiation dose.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. 18 - 100 years of age
4. KPS ≥ 70 or ECOG ≥ 1
5. Will receive RT using computed tomography (CT)-based treatment planning that will involve delivery of dose to the heart
6. Estimated by the treating radiation oncologist at the time of simulation to have a mean left ventricular dose of at least 5 Gy

Exclusion Criteria:

1. Previous history of RT to the thorax or breast
2. Implanted device that is non-MRI compatible or any implanted device in chest
3. Known gadolinium contrast allergy or other contraindication to CMRI scan. Patients needing sedation or medication for claustrophobia or anxiety will not be excluded from participating.
4. Found to be pregnant or breast-feeding
5. Known history of atrial fibrillation or frequent ventricular or atrial premature beats
6. Known history of chronic kidney disease (such as, but not limited, to a glomerular filtration rate \< 60mL/min)
7. History of coronary artery disease or myocardial disease
8. History of hypertension, requiring \>1 antihypertensive agent to maintain blood pressure \<140/90
9. Known history of valvular stenosis or regurgitation of \> moderate severity
10. Known history of heart failure (defined as baseline New York Heart Association Class III or IV (see Appendix A)
11. Systolic blood pressure \< 90mmGy
12. Pulse \< 50/minute
13. Known history of pulmonary hypertension or elevated right ventricular systolic pressures.
14. Suspicion or diagnosis of amyloidosis
15. Suspicion or diagnosis of hemochromatosis
Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician?

Warfarin is a medication typically referred to as a blood thinner and is used to prevent the formation of blood clots, and hence prevent life-threatening events such as strokes and clots on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the degree of blood thinning is kept within a narrow window - if the blood is "too thick" clots may form but if the blood is "too thin" the risk of bleeding increases. Complicating the control of warfarin is that different people require different amounts of it to have an appropriate degree of blood thinning, and once this amount is determined for a patient, it may be changed by factors that are encountered on a daily basis (i.e., diet, acute and chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has demonstrated really good control of blood thinning therapy by working with patients to inform them of the rationale for this medicine, the factors having the ability to impact its control, and encouraging the patient to be involved in their care (via provision of tools to document test results, one-on-one education and access to our program at any time with questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource limitations. As such, it is imperative that we investigate alternate strategies to manage these patients. Paramount, however, is that any long-term strategy must not confer inferior control of warfarin. The purpose of this study is to determine if the impact of AMS Care is sustained following the transfer of anticoagulation management to the family doctor. Operationally, the results of this study will guide future management of patients. If control of warfarin therapy declines with family doctor management, alternate strategies, such as patient self-management, will need to be investigated in a larger scale trial.


Eligibility Criteria:
Inclusion Criteria:

* current patient of the Anticoagulation Management Service
* anticipated need for long term anticoagulation
* have a regular primary care physician

Exclusion Criteria:

* previous failure of warfarin therapy (a bleed or clot despite therapeutic anticoagulation
* have a planned procedure (surgery) mandating discontinuation of warfarin
* are taking warfarin for a mechanical valve indication
Atorvastatin for HAART Suboptimal Responders

We hypothesise that atorvastatin changes immune activation among HAART-treated adults with suboptimal cluster cell differentiation 4 (CD4) recovery by 25%

The investigators have previously shown that up to 40% of HAART-treated adults have suboptimal CD4 recovery despite viral suppression. The investigators have also shown that immune activation and exhaustion are significantly higher among patients that do not exhibit satisfactory rise in CD4 counts despite viral suppression (suboptimal responders); when compared with their counterparts with viral suppression and satifactory CD4 count recovery (optimal responders). Given that atorvastatin changes immune activation in this pilot study, then larger studies can be done to understand its effect on CD4 count increase among suboptimal responders.

Eligibility Criteria:
List of inclusion Criteria: HIV-infected adults on antiretroviral therapy for at least 6 years with sustained viral suppression (viral load\<400 copies), and CD4 increase below 300 cells (difference between current and baseline CD4 count).

List of exclusion Criteria: History of an opportunistic infection within the previous six months, Pregnancy, History of myositis, History of ingestion of lipid-lowering agents at the baseline visit, Use of therapeutic agents known to have substantial drug-drug interactions with statins, and individuals on PI-containing HAART
ADVANCE MPI 2: Study of Regadenoson Versus Adenoscan® in Patients Undergoing Myocardial Perfusion Imaging (MPI)

Adenoscan® (adenosine) is an approved pharmacological stress agent indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. The investigational drug, regadenoson (CVT-3146) is a selective A2A adenosine receptor agonist, the receptor responsible for coronary vasodilation, and is being studied for potential use as a pharmacologic stress agent in myocardial perfusion imaging (MPI) studies. This study will compare the safety and efficacy of regadenoson to that of Adenoscan in detecting reversible myocardial perfusion defects.

ADVANCE MPI 2 is a multi-national, double-blind, randomized, active-controlled, parallel group clinical trial to evaluate the safety and efficacy of regadenoson in SPECT MPI compared to that of the approved pharmacological stress agent, Adenoscan. Patients referred for a clinically indicated pharmacological stress MPI study will be eligible for enrollment. The trial is designed: (1) to compare the pharmacological stress SPECT images obtained with regadenoson to those obtained with Adenoscan, and (2) to compare the safety and tolerability of the two stress agents.

Eligibility Criteria:
Inclusion Criteria:

* Referred for a clinically indicated pharmacological stress SPECT myocardial perfusion imaging study

Exclusion Criteria:

* Any condition precluding the safe administration of Adenoscan for a SPECT myocardial perfusion imaging study
* Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control
Group Yoga Therapy at a College Counseling Center

Clients of the student counseling center at Oklahoma State University who are interested in participating in the study will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Outcome of the three conditions will be compared.

Clients will be screened for appropriateness for group treatment and yoga. They will be randomly assigned to a traditional process group, a yoga class, and a yoga therapy group. Each condition will run concurrently for 8 weeks. Outcome measures will be administered before trial commencement and after the trial ends.

Eligibility Criteria:
Inclusion Criteria:

* Students at Oklahoma State University
* Appropriate for group therapy
* Physically capable of doing yoga

Exclusion Criteria:

* non-students
* inappropriate for group therapy treatment
* physical injuries not appropriate for yoga participation
Usefulness of a Mobile Information Management System for Haemodialysis Patient

The investigators developed and used the DialysisNet mobile application for physicians and Avatar Beans mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard. The investigators enrolled 10 patients and 4 physicians. Questionnaires to evaluate user experience and usefulness were administered before and after use.


Eligibility Criteria:
Inclusion Criteria:

* patients who have maintenance hemodialysis treatment
* accept consent form

Exclusion Criteria:

* pregnant
Mobile Health Device Study for Myeloma Patients

Enrolled participants health status will be tracked by using a mobile health-monitoring device while undergoing chemotherapy for multiple myeloma.

Newly diagnosed multiple myeloma participants receiving induction chemotherapy will be continuously bio-monitored at baseline (1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles using the Garmin Vivofit wearable device. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT. The study will include a total of 40 newly diagnosed multiple myeloma participants in two cohorts with 20 patients in each cohort (Cohort A and B). Cohort A will be comprised of patients \<65 years. Cohort B will be comprised of patients \>/= 65 years.

Eligibility Criteria:
Inclusion Criteria

Newly diagnosed Multiple Myeloma meeting International Myeloma Working Group (IMWG) criteria (as below) participants with clinical and histological confirmation of diagnosis planning to receive chemotherapy are eligible:

* Newly diagnosed Multiple Myeloma patients will have evidence of underlying end organ damage and/or myeloma defining event attributed to underlying plasma cell proliferative disorder meeting at least one of the following:
* Hypercalcemia: serum calcium \>0.25 mmol/L (\> 1 mg/dL) above upper limit of normal or ≥ 2.75 mmol/L (11 mg/dL)
* Anemia: hemoglobin value \<10 g/dL or \> 2 g/dL below lower limit of normal
* Bone disease: ≥ 1 lytic lesions on skeletal X-ray, CT, or PET-CT. For patients with 1 lytic lesion, bone marrow should demonstrate ≥ 10% clonal plasma cells
* Clonal bone marrow plasma cell percentage ≥ 60%
* Involved/un-involved serum free light chain ratio ≥100 and involved free light chain \>100 mg/L
* \> 1 focal lesion on magnetic resonance imaging study (lesion must be \>5 mm) in size
* All study participants will be required to receive primary chemotherapy treatment at a Memorial Sloan Kettering facility, including regional outpatient sites.
* All study participants will be required to have a smart phone or tablet device compatible with the Garmin Vivofit device.

Exclusion Criteria

* Plasma cell leukemia
* POEMS syndrome
* Amyloidosis
Intracardiac Hemodynamics and Myocardial Strain in Athletes and First Responders

The goal of this observational study is to compare the differences of intracardiac hemodynamics and myocardial strain in athletes with different training levels to adapt to long-term high-level training in rest conditions. The main questions aim to answer are: 1. whether an increase in amplitude and duration of intracardiac hemodynamics and myocardial strain compared with healthy controls; 2. Whether significant correlations exist between the hemodynamic indices and training level.

Participants will be asked to filling out the questionnaire, such as the age, training year (the number of years the athlete has participated in any sport), technical hierarchy (promoted by the Competitive Sports Department of the General Administration of Sport of China, weekly training time in the last 6 months, height, weight, body surface area, heart rate, systolic blood pressure, and diastolic blood pressure; and will be asked to perform an examination of transthoracic echocardiography.

Researchers will compare differences of cardiac structure and function, especially the hemodynamics and myocardial strain to see if training level could affect the cardiac function through hemodynamics and myocardial strain.


Eligibility Criteria:
Inclusion Criteria:

* athletes and healthy control subjects without regular exercise habits;
* no specific medical history or chronic illness.

Exclusion Criteria:

* A previous history of arterial hypertension, diabetes mellitus, heart, kidney, hepatic, infectious, psychiatric, malignant, disorders, taking drugs that can influence ECG intervals, and electrolyte imbalance;
* poor echocardiographic image quality and abnormal segmental ventricular wall movement.