cyrilzakka/clinical-trials huggingface dataset:
Procalcitonin and Endotoxin Sequential Levels to Optimize the Treatment of Bloodstream Infections

Bloodstream infections (BSI) are a major cause of morbidity and mortality. Bloodstream infections are also costly and result in prolonged hospital stays. The duration of therapy necessary to clear blood stream infections is unknown and no study has systematically addressed this issue. However, the use of antimicrobials is not without consequence. These include financial cost, side-effects, promotion of superinfection (especially Clostridium difficile-associated diarrhea), and the promotion of microbial resistance. This study hypothesizes that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker) guided treatment plan could significantly decrease unnecessary exposure to antibiotics in patients with bloodstream infections.

Bloodstream infections (BSI) are a major cause of morbidity and mortality. Community-onset BSI have an overall attributable mortality of 10-13% while nosocomial BSI mortality ranges are quite variable from 12-80%. Bloodstream infections are also costly and result in prolonged hospital stays. Nosocomial BSIs have been shown to increase length of stay by 5-25 days and increase costs $23,000 - 40,000 above matched controls. The duration of therapy necessary to clear blood stream infections is unknown and no study has systematically addressed this issue. The use of antimicrobials is also not without consequence. These include financial cost, side-effects, promotion of superinfection (especially Clostridium difficile-associated diarrhea), and the promotion of microbial resistance. This study hypothesizes that a procalcitonin (host biomarker) and endotoxin (microorganism biomarker) guided treatment plan could significantly decrease unnecessary exposure to antibiotics in patients with bloodstream infections.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized, adult patient, at least one positive blood culture reported within 24 hours of enrollment

Exclusion Criteria:

* Previously enrolled in the study; discharged/deceased before first positive culture; receiving antibiotic for greater than or equal to 48 hours; endocarditis or osteomyelitis; antithymocyte globulin in the last 12 months; blood cultures positive for coagulase-negative staphylococcus only.
The Study of Infrared Imaging on Breast Cancer

Breast cancer can cause focal temperature increase on the breast skin due to vasodilatation mediated by NO secretion from cancer cells. Our study is to evaluate this situation and to assess the diagnostic efficacy of infrared imaging (thermography)on breast cancer.

Malignant breast neoplasms can secrete NO to induce focal vasodilatation and increased blood flow and angiogenesis to the tumor, thus increase the focal temperature, which can be evaluated by breast thermography (infrared imaging). We will evaluate the efficacy of infrared imaging for detection and diagnosis of breast cancer, and if infrared imaging can effectively differentiate malignant from benign breast dieases and the sensitivity, specificity, false-negative rate will also be estimated.

Eligibility Criteria:
Inclusion Criteria:

* normal group: women who has normal mammograms or ultrasound in 6 months abnormal group: women who has suspicious findings on mammograms or ultrasound in recent 6 months

Exclusion Criteria:

* women who don't fit the above inclusion criteria
All-extremity Exercise During Breast Cancer Chemotherapy

Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.


Eligibility Criteria:
Inclusion Criteria:

* Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
* Female
* 18 to 85 years of age
* Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
* Absence of contraindications to exercise
* Study clinician approval
* Able to give consent
* Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process

Exclusion Criteria:

* Do not meet inclusion criteria
* Receiving targeted therapies (CDK4/6 or PARP inhibitors)
* Receiving radiation therapy concurrent with chemotherapy
* Lymphedema stage ≥ 2 prior to study enrollment
* Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
* Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases

Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.

It is planned to use posterior stabilization without interbody fusion. In the postoperative period, all the patients receive antibacterial and analgesic therapy. The early postoperative period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12 months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and performing radiographs or computed tomography (CT) of the spine. All patients undergo a standard rehabilitation course.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the patient to participate in the study;
* Patients with degenerative diseases of the lumbar spine.
* The opportunity for observation during the entire study period (12 months);
* Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations.

Exclusion Criteria:

* The refusal of a patient from surgery
* The presence of contraindications to surgery
* Severe forms of diabetes (glycosylated hemoglobin \>9%);
* Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb\< 90g\\l);
* The unwillingness of the patient to conscious cooperation.
Emotional Intelligence Skills Health Leaders Need During Covid-19

Problem The study will address the problem that no studies have established the Emotional Intelligence (EI) skills required by leaders and managers to engage frontline healthcare professionals in crisis situation like Covid19 in Kenya Purpose The purpose of the qualitative exploratory study is to identify the EI skills Leaders and managers need to engage Frontline Healthcare Professionals in Crisis.

The Research Question is:

What are the EI skills leaders and managers need to engage frontline healthcare professionals (FHP) during crisis situations such as the Covid19 pandemic?

Hypothesis The Study hypothesis that Leaders and managers with appropriate emotional intelligence skills will engage frontline healthcare professionals in crisis situations resulting in desired outcomes Data Collection The data collection will start with a primer survey on surveymonkey.com, behavioral and cognitive assessments through The Predictive Index, emotional intelligence competence assessments through emco4.com, followed by semi-structured face to face or virtual interviews with the participants. The Survey data, Assessments and the transcribed semi-structured interviews will be depersonalized and made available for subsequent researchers. The Videos if any will be destroyed three years after transcription.

Participants The 20 Participants will be selected from the population. The Study population is the number of experienced frontline healthcare professionals working in Busia County of Kenya. The County Department of Health will help in recruiting participants from doctors, nurses, and other frontline healthcare professionals.

Data Analysis The Data will be analyzed using DiscoverText.com cloud-based platform applying two rounds of coding: first in Vivo coding will be applied then prior codes will be enforced. The Vivo codes will be in the participant's word and voice. Eight priori codes will be adopted from EI literature.

Societal Benefits Society needs healthcare professionals to deal with crisis situations that place them in imperilment. The leaders have constraints of resources, time and advanced knowledge. This study seeks to seek out EI skills that will enable leaders to engage healthcare professionals while recognizing the humanity in them.

Eligibility Criteria:
Inclusion Criteria:

Experience frontline healthcare professionals working in Busia County of Kenya

Exclusion Criteria:

* None healthcare professionals
* healthcare professionals not working in Busia county
Respiratory Physiology in Children With Febrile Seizures.

Febrile seizures occur in 2-5% of the population and are typically limited to children between 3 months and 5 years-of-age. The pathophysiological link between increased body temperature and increased seizure susceptibility is unsolved in humans. In a mouse model it has been shown that young animals had a tendency to hyperventilate thereby causing intra-cerebral hypocapnia / alkalosis and a decrease of their seizure threshold. This effect was not observed in older animals. Redressing the pCO2 (carbon dioxide partial pressure) by breathing carbon dioxide enriched air instantly stopped the seizures.

In this study the investigators want to investigate the respiratory physiology in children with febrile seizures and compare it to children who have fever but did not have febrile seizures.

The investigators hypothesize that in children with febrile seizures the rising body temperature triggers a larger increase of respiratory rate (hyperventilation) and subsequent drop in pCO2 levels.

This study could provide the basic physiological data for an interventional trial to test the efficacy of carbon dioxide inhalation to interrupt febrile seizures.

The aim of the study is the continuous non-invasive monitoring of

* body temperature
* respiratory rate
* transcutaneous pCO2
* heart rate
* pulsoxymetric SaO2 (arterial oxygen saturation) during a febrile illness
* in children without febrile seizures and
* in children who had suffered a febrile seizure during the actual febrile illness.

Children will be recruited from the emergency units of the Charité University Hospital and a large Community Hospital, matched according to age, gender and the cause of their febrile illness and their data will enter final analysis if their body temperature rose at least once to or above 38.0 degree C and changed more than 1.0 degree C during the observational period.

Eligibility Criteria:
Inclusion Criteria:

* Febrile illness with body temperature ≥38.0 degree C
* 50% of study population: never had a febrile seizure
* 50% of study population: simple or complex febrile seizure within one day of investigation
* Change of body temperature of ≥1.0 degree C during the monitoring period
* Provision of written informed consent by the parents or guardians of the child
* Artefact-free simultaneous measurement of respiratory rate, pCO2 (transcutaneous probe), body temperature (rectal probe), and heart rate during change of body temperature of ≥1.0 degree C.

Exclusion Criteria:

* Past history of afebrile seizures
* Past history of neonatal seizures
* Retarded psychomotor development
* Chronic respiratory disease
* Cardiologic disease
* Severe other organ disease
* Permanent medication for chronic disorder
* Therapeutic increase of inspiratory oxygen concentrations during the observational period
Expansion of Abbreviations and Acronyms for Patients

This is a prospective, two-arm, parallel, individually randomized controlled trial to estimate the effect of expansion on patient comprehension (primary outcome) of abbreviations and acronyms in their health records. English-speaking adult patients with diagnosed heart failure who receive primary care at three urban hospitals in New York City will be considered. The investigators hypothesize that expansion will significantly increase patient comprehension of abbreviations and acronyms in the health record.

Importance: In 2020, an estimated 100 million Americans accessed their own health records online. That number likely increased beginning April 2021, when U.S. federal rules implemented the 21st Century Cures Act requiring electronic health information to be made freely accessible. Medical abbreviations and acronyms may limit patient understanding of health records. Automated expansion is one potential solution, however, the magnitude of its effect on patient comprehension has not been estimated.

Objective: To estimate the effect of expansion on patient comprehension of abbreviations and acronyms in their health records.

Design: Prospective, two-arm, parallel, individually randomized controlled trial.

Participants: Patients who receive primary care at one of three urban hospitals. A purposive sample representative on age, gender, and race will be enrolled between February 2020 and August 2021. To isolate the main effect, the investigators will include only English-speaking adult patients with diagnosed heart failure.

Intervention: Participants will be randomized to receive clinical text with abbreviations (control group, n=30) or with expansions (intervention group, n=30). The abbreviations and expansions included "hrs" (hours), "MD" (medical doctor), "BP" (blood pressure), "ED" (emergency department), "yo" (year old), "pt" (patient), "HF" (heart failure), "hx" (history), "HTN" (hypertension), "MI" (myocardial infarction).

Eligibility Criteria:
Inclusion Criteria:

* Adult (21 years or older)
* Confirmed diagnosis of heart failure
* Able to read and speak English
* Willing and able to provide informed consent
* Receives primary care from participating provider

Exclusion Criteria:

* Healthcare professional (MD, DO, RN, etc.)
* No telephone number or email address
* Severe cognitive impairment or clinical diagnosis of dementia
* Major psychiatric illness, including active psychosis
* Other illness that would preclude participation
Current Treatment Strategy of Patients With Multivessel Disease or Left Main Coronary Artery Disease Indicated for Coronary Artery Bypass Graft Surgery

According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was recommended for three-vessel coronary artery disease and left main coronary artery disease in the patients with stable ischemic heart disease as class I. 2-VD with proximal left anterior descending artery stenosis was also indicated for CABG surgery as class I recommendation. However, many patients have been recommended for PCI by catheterization laboratory cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI candidates, retrospectively, defined by previous ACC/AHA guideline. Although the discordance between real practice in catheterization laboratory and guideline would be adjusted by recently updated guideline. The revascularization strategy for patients with 3-VD/LMD in real practice have been getting toward more PCI and less CABG surgery. In this study, we will identify the rate of CABG candidates who were treated with PCI or medical treatment instead of CABG surgery in different from current guideline. We are also going to compare two treatment strategies CABG surgery vs. PCI with 2nd generation DES regarding clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 19 years old
* Left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis.

Exclusion Criteria:

* Previous PCI within 1 year
* Previous sternotomy
* Primary PCI for STEMI
* Contraindication or hypersensitivity to anti-platelet medications or contrast media
* Planned need for concomitant other cardiac surgery (eg, valve surgery or resection of aortic or left ventricular aneurysm, etc)
* Pregnant women or women with potential childbearing
* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
* Inability to understand or read the informed content
Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

To systematically develop, test, and refine peripheral vascular electrocardiography-gated fast spin echo magnetic resonance imaging for the accurate diagnosis of peripheral arterial disease without gadolinium contrast.

To test prospectively the accuracy of fast spin echo in peripheral arterial disease patients, compared with bolus-chase and time-resolved gadolinium enhanced magnetic resonance angiography. Additionally, as a substudy of this project, we will compare our fast spin echo approach with alternative non-contrast-enhanced magnetic resonance imaging methods such as time-of-flight and steady-state gradient echo imaging.

The overarching goals of our research are to develop and validate a peripheral magnetic resonance imaging technique that accurately depicts anatomy and disease without exposing patients to exogenous contrast material and its associated risks.


Eligibility Criteria:
Inclusion Criteria:

* Patients with known or suspected periphery arterial disease will be recruited.
* In the initial sequence optimization stage, healthy volunteers will also be recruited for magnetic resonance angiography

Exclusion Criteria:

* Patients with moderate to end stage renal disease (estimated glomerular filtration rate \< 30 ml/min/1.73m2). These patients will not be recruited as they will be unlikely to undergo routine contrast enhanced magnetic resonance angiography due to the risk of developing Nephrogenic Systemic Fibrosis.
* Pregnant patients. Gadolinium chelates are a FDA Category C drug, and therefore should be avoided in pregnancy.
* Claustrophobic healthy volunteers or any subject who is unable to lie flat for 60 minutes.
* Glomerular filtration rate \< 60ml/min/1.72m2 and coexisting history of pro inflammatory conditions such as recent surgery, sepsis or major infection, arterial or venous thrombosis.
* Any history of nephrogenic systemic fibrosis
* Unable/ unwilling to give informed consent
* Medical contra-indications to magnetic resonance imaging: e.g. pacemakers, implanted defibrillators, cochlear implants, aneurysm clips, and prior/ current metal workers. Patients will be screened with a safety questionnaire.
* Clinically unstable patients
* Patients with newly placed stents will be excluded until 8 weeks post placement
Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device diagnostics that have an implanted commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).

The study is expected to be conducted at up to 20 centers located in the United States. Up to 400 subjects will be enrolled to yield up to 200 eligible subjects that meet screening criteria. This study will be conducted in subjects with an implanted, commercially available, Medtronic, CRT-D device. Each enrolled subject will be followed every 2 months from time of enrollment to end of the study.The study will end after the last enrolled subject completes the 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
* Subject has been implanted with a CRT device for at least 9 months and has had a wireless Medtronic CRT-D device for at least 34 days
* Subject has \>1 year life expectancy
* Subject's CRT-D device has at least 18 months of device longevity left
* Subject has an eGFR\> 25 ml/min/1.73 m2
* Subject is NYHA Class II or III
* Subject is NYHA Class II or III • Subject has elevated BNP values (BNP\>400 or NTpro BNP\>800) within the last 3 months OR Subject has had at least one OptiVol threshold crossing in the last 9 months OR Subject has had a HF event within the last 9 months

HF event is defined as meeting any one of the following two criteria:

1. Subject was admitted to the hospital for worsening HF OR
2. Subject has received Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any settings including:

   * Emergency Department
   * Ambulance
   * Observation Unit
   * Urgent Care
   * HF/Cardiology Clinic
   * Patient's Home

     * Subjects who are currently prescribed and taking medications for the management of heart failure and are able to tolerate transient increases in diuretic dosage
     * Subject is willing and able to comply with the protocol, including screening, baseline and programming visit(s), remote care directions, follow-up visits, and exit visit
     * Subject can send device transmissions and daily biometric data with in-home patient devices

Exclusion Criteria

* Subject has systolic BP of \< 90 mmHg at the time of enrollment
* Subject not responsive to diuretic therapy or is on chronic renal dialysis
* Subject unable to undergo one round of medication intervention (3 day up-titration of diuretic) without requiring safety check
* Subjects enrolled in a concurrent study that may confound the results of this study without documented pre-approval from a Medtronic study manager
* Subject weighs more than 500 pounds
* Subject is younger than 18 years of age
* Subject has hemodynamic monitoring device implanted
Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCL

Expanded Access Program (EAP) to provide Tafasitamab (MOR208) to eligible patients with relapsed or refractory Diffuse Large B Cell Lymphoma. Access to MorphoSys´ EAP can be requested by contacting the respective CRO Clinigen (tafasitamab@clinigengroup.com).

This program is intended to provide access to patients with relapsed and/or refractory DLBCL who had at least one prior anti-CD20 containing regimen. Patients with primary refractory disease and double/triple hit status are also eligible. Patients considering this access program should have no other therapeutic option, and are not eligible for other clinical trials. The expanded access program (MOR208N001) is currently available in the United States only.

Eligibility Criteria:
Major Inclusion Criteria :

1. Age ≥ 18 years
2. Patient able to provide written informed consent
3. Histologically-confirmed diagnosis of DLBCL, including transformation from an earlier diagnosis of indolent lymphoma.
4. Patients must have relapsed and/or refractory DLBCL, including primary refractory disease and double/triple hit status, after at least 1 prior anti-CD20 containing regimen.
5. Patients with a serious, life-threatening illness in which conventional therapies have failed, are unsuitable and/or are unavailable and participation in ongoing relevant clinical trials is not feasible.

Major Exclusion Criteria:

1. Patients who have other histological type of lymphoma, e.g. indolent Non-Hodgkin lymphoma (NHL), Primary mediastinal B-cell lymphoma (PMBL) or Burkitt Lymphoma
2. Patients who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period with lenalidomide
3. Patients with:

   1. Known active bacterial and viral and fungal infections
   2. Serology of chronic active viral Hepatitis B and/or C-Hepatitis
   3. Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
4. Patients who are unable to participate in the lenalidomide REMS program