cyrilzakka/clinical-trials huggingface dataset:
Education of Providers on Prescribing Best Practices

This study aims to evaluate the impact of spaced education, delivered via a smartphone application, on provider prescribing patterns.

As part of a medical center educational initiative at Vanderbilt University Medical Center (VUMC), two educational modules will be sent to prescribing providers through either email or short message service (SMS) text messaging. The first educational module consists of a set of multiple choice questions concerning best practices for prescribing intravenous fluids in the inpatient and perioperative setting. This module is based upon recent literature and specifically derived from the results of the Isotonic Solutions and Major Adverse Renal Events Trial (SMART) and Saline Against Lactated Ringer's or Plasma-Lyte in the Emergency Department (SALT-ED) trial, both published in the New England Journal of Medicine in 2018 and led by Vanderbilt investigators. Similarly, a second educational module concerning evidence-based pain management and opioid prescribing practices will be distributed via email or SMS text messaging.

Participants will receive one question per day. If the participant does not answer the question correctly, they will receive the opportunity to attempt the question again after reviewing evidence-based education. All questions have been curated and reviewed by a panel of experts and piloted within VUMC for feasibility and acceptability. Key concepts are repeated in each module and questions are strategically ordered throughout each module to accomplish spaced education.

Eligibility Criteria:
Inclusion Criteria:

* All inpatient prescribing providers

Exclusion Criteria:

* none
Adult Double Cord Blood Transplant Study

The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.


Eligibility Criteria:
Inclusion Criteria:

* Age 22 - 50 years
* Patients will have one of the following hematological malignancies:

  * Acute myelogenous leukemia (AML): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
  * Acute lymphoblastic leukemia (ALL): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
  * Acute undifferentiated leukemia (AUL) or biphenotypic leukemia: CR1 or CR2
  * Myelodysplastic Syndrome (MDS) with one of the following: Low and Intermediate-1 International Prognostic Scoring System (IPSS) score with Life-threatening neutropenia or thrombocytopenia; or Platelet transfusion dependence Intermediate-2 or High IPSS score Therapy-related disease: patient with history of chemotherapy and current evidence of MDS
* Patients with adequate organ function and performance status criteria
* Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.

Exclusion Criteria:

* Patient with suitable related donor
* AML, ALL, AUL, biphenotypic leukemia beyond CR2
* AML evolved from myelofibrosis
* Any acute leukemia with:

  * Morphologic relapse or persistent disease in the BM
  * Active extra-medullary leukemia including active CNS leukemia
  * Requiring greater than two cycles of chemotherapy to obtain present remission status
* Bone marrow aplasia (defined as BM cellularity \< 5% at transplant work-up)
* MDS with 10% or greater bone marrow blasts at pre-transplant workup
* Prior autologous or allogeneic HSC transplant at any time
* Prior radiation therapy rendering patient ineligible for TBI
* Any uncontrolled infection at time of study enrollment
* Seropositive or NAT positive for HIV or HTLV1
* Females who are pregnant or breast feeding
* Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests
Twelve Leads Electrocardiographic Expressions at Different Body Positioning

Electrical conduction in the heart produces a heartbeat; electrical signals are sent to the heart muscle upon each contraction, causing the heart to pump blood. These electrical impulses are recorded by an electrocardiogram (ECG), which makes it possible to evaluate electrical conduction and cardiac rhythm. ECG is a non-invasive technique used to assess pacemaker function and perioperative heart health. Ten electrodes are used in the 12-lead ECG, the gold standard for diagnosing cardiac illness and anatomy, to record the electrical activity of the heart from various perspectives. With wireless data transmission to the cloud, this technology is now included into emergency and ambulance situations, streamlining processes and improving signal quality. The purpose of this observational study is to examine 12-lead electrocardiogram data for better clinical application and diagnosis.

The heartbeat is a result of electrical conduction in the heart. The heart's contractions release electrical signals that trigger the heart muscle to pump blood to the lungs and the rest of the body. An electrocardiogram (ECG) records these electrical signals from each heartbeat, allowing for the observation of heart rhythm and the assessment of any abnormalities in electrical conduction. The ECG is a non-invasive monitoring tool used for evaluating heart health throughout the perioperative period and for checking the function of pacemakers. By analyzing the shape, size, and time intervals of these waveforms, ECGs provide visual representations that help healthcare professionals assess conditions related to heart valve diseases.

The 12-lead ECG is considered the gold standard for evaluating cardiac structure and diagnosing various heart conditions. This system consists of twelve leads created from ten electrodes, recording the heart rates electrical activity from different angles in three-dimensional space to understand the condition of various heart regions. Currently, 12-lead ECG machines are widely used in emergency and ambulance settings. They often incorporate integrated electrode patches that replace the traditional ten individual electrode patches, significantly simplifying the process and reducing errors. This integration improves signal transmission and quality compared to traditional ECG leads. Data is transmitted wirelessly, paired with mobile device software, and sent to the cloud to support diagnostic reports.

This study is an observational research project aimed at establishing and analyzing 12-lead ECG data. The goal is to utilize this data for more in-depth diagnostics and to observe its differences and clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18\~65 years of age
* Fluent in either Taiwanese/Chinese/English.

Exclusion Criteria:

* Pregnancy
* Refusal to give informed consent
* Candidate for coronary bypass surgery or valves surgery or other cardiac surgery
* Participants with diagnosed arrhythmia, ischemic heart disease or congestive heart failure
A Phase II Study of Amifostine for the Prevention of Acute Radiation-Induced Rectal Toxicity

The purpose of this study is to evaluate the effect of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

To evaluate the different use way of intrarectal Amifostine administration on acute radiation-induced rectal toxicity in pre-operative chemo-radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
* tumor distance from anus less than 12 cm.
* KPS score not less than 70
* can be tolerated chemotherapy and radiotherapy.
* pelvic who had no history of radiation therapy.
* Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
* blood pressure can be controlled by drugs in the normal range (90 ≤ systolic blood pressure ≤ 140,60 ≤ diastolic blood pressure ≤ 90).
* a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent.

Exclusion Criteria:

* other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
* pregnant or lactating patients.
* fertility but did not use contraceptive measures.
* existing active infection.
* merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
* concurrent treatment with other anticancer drugs.
* can not complete treatment or follow-up.
Compassionate Use for Subcutaneous (SC) Belimumab

GlaxoSmithKline (GSK) have submitted a Biologic License Application (BLA) for the subcutaneous formulation of belimumab which is currently under review by the Food and Drug Administration (FDA). The goal of this individual patient compassionate use supply is to provide a patient with subcutaneous belimumab for the period of 1 year or until the subcutaneous formulation of belimumab becomes approved for use by the FDA and is commercially available to this patient, whichever is sooner. You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.


Eligibility Criteria:
This is a protocol to support an emergency IND for compassionate use in one patient requiring use of belimumab subcutaneous for SLE treatment (lacks venous access and cannot receive IV belimumab).

Eligibility criteria is based on the following, as provided within GSK's policy on compassionate use:

* The illness being treated is life threatening or seriously debilitating.
* There are no satisfactory alternative treatments (confirmed by the HCP).
* There is sufficient evidence to believe the benefit to the patient justifies the risk You can access GSK's Policy on Compassionate via http://www.gsk.com/media/3368/compassionate-use.pdf.
Post Marketing Study to Evaluate the NIMBUS Device

A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

The objective of this study is to assess the efficacy of the NIMBUS Device. The study will also report on clot characteristics and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* The subject or the subject's legally authorized representative has signed and dated an Informed Consent Form.
* Patient has had one or two passes of another mechanical thrombectomy device without achieving mTICI 2b or better and continues to have angiographic confirmation of a Large Vessel Occlusion (LVO) in the same vessel.
* mRS 0-1 prior to this stroke.
* NIMBUS is used on the second or third overall pass to attempt revascularization.

Exclusion Criteria:

* Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
* Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).
* All patients with severe hypertension on presentation (SBP \> 220 mmHg and/or DBP \> 120 mm Hg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy (SBP \>185 mmHg and/ or DBP \>110 mmHg).
* Known cerebral vasculitis.
* Known cancer with life expectancy less than 12 months.
* Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion.
* Intracranial stenosis that prevents access to the site of occlusion.
* Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
* Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
* Evidence of dissection in the extra or intracranial cerebral arteries.
* Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D).

The study will last about 56 weeks and include up to 12 visits.


Eligibility Criteria:
Inclusion Criteria:

All participants with or without diabetes:

* Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening
* Diagnosed with chronic kidney disease (CKD)
* Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) \>30 milligram/gram (mg/g)
* Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension)

Participants without diabetes:

* Have Hemoglobin A1c (HbA1c) \<6.5% at screening

Participants with Type 2 diabetes:

* Have been diagnosed at least 180 days prior to screening
* Have HbA1c ≤9.5% at screening

Exclusion Criteria:

All participants:

* Have a self-reported change in body weight \>5 kilogram (kg) within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity
* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days
* Have eGFR \<25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening.
* Have a history of unstable or rapidly progressing renal disease according to investigator judgment
* Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility)
* Have had a history of chronic or acute pancreatitis

Participants with T2D:

* Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment.
* Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma
Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.

Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously.

The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.

Eligibility Criteria:
Inclusion Criteria:

* • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following:

  1. History of postpartum hemorrhage.
  2. Delivery of a macrosomic baby (\> 4000 g).
  3. Multiple gestation.
  4. Polyhydramnios.
  5. Grand Multiparity.
  6. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata)
  7. Chorioamnionitis.

Exclusion Criteria:

* • Patients without high risk for post-partum hemorrhage.

  * Patients at high risk for postpartum hemorrhage but will deliver vaginally.
  * Patients with medical disorders complicating pregnancy.
  * Patients with coagulation defects.
  * Preterm pregnancies.
Anemia of Inflammation and Deficiency Anemia

Critical patients which requiring admission to intensive care (IT) are a special group of patients. In these patients the prevalence of anemia reported in studies is 75%. This prevalence is similar to that in the retrospective observational study conducted in our intensive care unit(ICU). Of the 783 patients included in the study, 551 (73.37%) had anemia on admission. Frequently anemia is present on discharge from ICU or hospital and may persist for an average of 11 weeks. Some studies have reported the presence of anemia as far as 6 months after discharge. It is widely accepted that anemia has a negative impact on rehabilitation and quality of life, but the treatment can not be exclusively based on blood products due to the risks associated with transfusion. Alternative treatments such as injectable iron or erythropoietin should be considered.

The Transfusion Management Initiative Group recently issued recommendations on perioperative anemia. Similar recommendations for ICU have not yet been developed in Romania. The current study has two main purposes. The first to adopt the perioperative anemia diagnostic algorithm and adapt it to anemic patients on ICU; the second to identify patients with mixed anemia (inflammatory and iron deficient anemia) who can benefit from treatment with iron.


Eligibility Criteria:
Inclusion Criteria:

Patients admitted to ICU

ICU stay \>48hours

Exclusion Criteria:

* Refusal to participate in the study
* Allergy to iron products
* Anemia requiring massive transfusion in the last 7 days
* Treatment of iron products in the last 7 days
* Chronic renal failure with GFR \<30mL / min or on dialysis
* Metabolism of iron
* Pregnant or lactation patients
* Rheumatic diseases
* Inflammatory bowel diseases
* Hematological pathologies
* Impossibility of performing laboratory tests within 72 hours of admission
Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure

Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there is no data (and even less so recommendations) on how to best conduct this technique, including its initiation and its weaning periods. Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

Nasal high flow oxygen therapy is increasingly used as a first-line treatment for hypoxemic acute respiratory failure, because of its remarkable tolerance (in comparison with NIV) and its physiological effects (nasopharyngeal dead space washout, positive end-expiratory pressure effect with possible alveolar recruitment, better matching with the patient's inspiratory flow, more reliable and adjustable FiO2); that together contribute to a reduction in respiratory workload and better oxygenation.

Although many studies have investigated the clinical benefits of nasal high flow during acute hypoxemic respiratory failure, there are no data (and even less recommendations) on how to best conduct this technique, including its initiation and its weaning periods.

Because different approaches exist among clinicians, investigators believe that a multicenter observational study that would collect data regarding the different ways high flow is conducted in patients with acute respiratory failure is necessary before performing an interventional study that would test and compare different strategies in order to answer the question: what are the best strategies (in terms of flow and FiO2 settings) to initiate and to wean high-flow oxygen therapy in patients with acute respiratory failure?

Investigators will assess in a multicenter, observational study, the way clinicians use nasal high flow therapy in patients with acute respiratory failure in order to try identify one or more strategies that may be then compared in an interventional study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* admitted to the intensive care unit (ICU) or to the intermediate care for acute hypoxemic respiratory failure (whatever the cause)
* treated with nasal high flow oxygen therapy
* with a minimal FiO2 of FiO2≥50% and a gas flow ≥40 L/min
* anticipated duration of nasal high flow therapy greater or equal to 24 hours

Non-inclusion Criteria:

* prophylactic, post-extubation nasal high flow therapy
* palliative nasal high flow therapy (do-not-resuscitate order)

Exclusion criteria

- nasal high flow therapy administered for less than 24 hours
Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography, may help find and diagnose cancer. It is not yet known whether standard diagnostic procedures are more effective when given with or without fludeoxyglucose F 18 positron emission tomography in finding cancer.

PURPOSE: This randomized clinical trial is studying fludeoxyglucose F 18 positron emission tomography given together with standard diagnostic procedures to see how well it works compared with standard diagnostic procedures alone in finding cancer in patients with a blood clot in a vein.

OBJECTIVES:

Primary

* Demonstrate the efficacy, in terms of increased numbers of cancer diagnoses, of PET-CT with 18-FDG in patients with idiopathic venous thromboembolism.

Secondary

* Assess the risk of cancer detected at 1 year.
* Assess whether PET allows earlier detection of cancer.
* Evaluate survival.

OUTLINE: This is a multicenter study.

All patients undergo standard (clinical and biological) diagnostic tests for cancer. Patients are randomized to 1 of 2 diagnostic arms.

* Arm I: Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.
* Arm II: Patients only undergo standard diagnostic methods. Patients are followed up for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of idiopathic venous thromboembolism (IVTE) meeting 1 of the following criteria:

  * Newly diagnosed
  * Recurrent disease controlled by anticoagulant therapy
* No IVTE caused by a reversible major risk factor
* No IVTE caused by a major constitutional risk factor, including any of the following:

  * Antiphospholipid antibody syndrome
  * Antithrombin deficit
  * Protein C
  * Protein S

PATIENT CHARACTERISTICS:

* Not pregnant
* No other known active cancer at the onset of IVTE