Kornimate/medical-research-clean huggingface dataset:
long-term effects of covid-19

Conditions: COVID-19; SAR-CoV-2

Summary: the purpose of this study is to measure, monitor, and analyze long term effects of sars-cov-2. the main purpose is to assess the post-hospitalization outcomes of patients who were diagnosed with sar-cov-2 by comparing to patients who were hospitalized with an acute neurological disease.


Eligibility criteria:
inclusion criteria: * control participants: males and females over the age of 18 years hospitalized and receiving intensive care for diagnosis's other than covid-19 or an acute neurological disease and who were not diagnosed (clinically or with pcr testing) with covid-19. * case participants: males and females over the age of 18 years who had been hospitalized at mayo clinic hospital for treatment of covid-19 confirmed by pcr test. * we acknowledge that some participants may be unable to consent due to underlying medical conditions; an eligible proxy may provide the informed consent and provide a signature on the designated line. * women of childbearing age, between the ages of 18 to 55, must complete a negative pregnancy test. * minority individuals over the age of 18 years will be eligible to enroll. exclusion criteria: * males and females, under the age of 18 years. * participants with pet/mri non-compatible devices. * claustrophobia. * allergies to study related procedures. * pregnant , incarcerated, or institutionalized subjects will not be included in the study.
samarium-153 with neoadjuvant hormonal and radiation therapy for locally advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the safety and effectiveness of samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.

the likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients. the use of samarium-153 edtmp in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. in these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and samarium-153 edtmp to treat localized and subclinical bony disease, respectively.

Eligibility criteria:
inclusion criteria: * psa 20-150 and gleason score greater than or equal to 7 or clinical stage greater than or equal to t2, gleason greater than or equal to 8, psa less than or equal to 150 * pathologically positive lymph nodes * pretreatment must be prior to study entry and prior to any hormonal therapy * zubrod 0-1 * adequate hematologic function exclusion criteria: * patients with psa equal to or greater than 150 * neuroendocrine features on histologic examination * radiologic evidence of metastatic disease * previous malignancy within last 5 years * prior pelvic radiation therapy or orchiectomy

Keywords: locally advanced prostate cancer positive lymph nodes
thromboprophylaxis in sickle cell disease with central venous catheters (this)

Conditions: Sickle Cell Disease; Central Venous Catheter Thrombosis; Venous Thromboembolism

Summary: research question: in adult scd patients with cvc, is it feasible and safe to conduct an adequately powered rct to evaluate the use of rivaroxaban as thromboprophylaxis in this population? study design: the study is a vanguard pilot double blind multi-centre randomized controlled trial. participants with scd and cvc will be randomized to either rivaroxaban 10mg po daily or placebo for the duration of cvc in situ or for up to one year, whichever is less. after screening (day -7 to day -1), patients will be followed at day 1, months 3 (+/- 15 days), 6 (+/- 15 days), 9 (+/- 15 days), and 12 (+/- 15 days). study objectives: the primary objective is to estimate the proportion of eligible patients who will enroll into a trial of thromboprophylaxis. secondary objectives include (a) document indications for central venous catheter (cvc), (b) summarize duration of cvc insertion prior to enrollment, (c) estimate adherence to the study drug, (d) estimate proportions of participants being compliant with study procedures, and lost to follow up. exploratory objectives will assess thrombotic, bleeding, and quality of life outcomes.


Eligibility criteria:
inclusion criteria: 1. adult (age 18 or older) 2. documented scd 3. new or pre-existing cvc planned for long term use (at least 6 months) 4. able to provide written consent exclusion criteria: 1. contra-indication to prophylactic dose anticoagulation or active bleeding at discretion of treating physician 2. already on anticoagulation (prophylactic or therapeutic dose) for an indication other than cvc thromboprophylaxis 3. previous vte within the past 3 months 4. pregnant, within 6 weeks post-partum, or active breast feeding 5. creatinine clearance \<30ml/min (as calculated by cockcroft-gault equation\[67\]) 6. acute hepatitis or chronic active hepatitis 7. cirrhosis with child-pugh score b or c 8. platelet count \< 50 x109/l 9. weight \<40kg 10. uncontrolled htn (systolic blood pressure \> 170mmhg, or diastolic blood pressure\> 100mmhg) despite antihypertensive treatment 11. on palliative care 12. on dual antiplatelet therapy, or high dose single agent aspirin \> 325mg/day 13. on combined p-glycoprotein and strong cytochrome p450 3a4 inhibitors (including but not limited to ketoconazole and protease inhibitors) 14. on combined p-glycoprotein and strong cytochrome p450 3a4 inducers (including but not limited to rifampin, phenytoin, phenobarbital, carbamazepine, and st. john's wort) 15. active cancer or treatment for cancer excluding basal cell carcinoma 16. known allergy to study drug 17. strong indication for thromboprophylaxis at discretion of treating physician 18. significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data.
perimenopausal estrogen replacement therapy study

Conditions: Perimenopause; Menopause; Depression

Summary: study background and objectives: in the u.s. the majority of heart disease deaths are in women, not men. much of the gender disparity in cvd rates relate to the burden of cv risk in women after the menopause. depression has been associated with an increased risk for cvd morbidity and mortality. even histories of recurrent depression in euthymic individuals are associated with elevated cv risk. understanding the depression-cvd link may have particular relevance for women since women experience depression at a rate twice that of men. substantial convergent evidence indicates that ovarian failure (estrogen deprivation) is one likely mechanism contributing to both cvd and depression in women. the perimenopause, a time associated with a two-fold increase in rates of depression, may provide an ideal opportunity for studying the pathophysiology of cv risk and depression in women. the primary objective of this study is to examine the prophylactic role of estradiol in the development of depressive symptoms and the progression of cardiovascular risk in perimenopausal women with or without histories of depression. the investigators predict that women susceptible to depression will be particularly vulnerable to the acceleration of cvd in the context of the perimenopause and, consequently, will show differentially greater benefit of estradiol treatment during the menopause transition for both indices of cv risk (e.g. inflammation, endothelial function, stress reactivity), as well as depressive symptoms.


Eligibility criteria:
inclusion criteria: * must be between 45 and 60 years of age * must be in the menopause transition (irregular/ absent menstrual cycles or hot flashes) * must be are medically healthy exclusion criteria: - currently taking antidepressant medication

Keywords: perimenopause menopause depression cardiovascular health
developing a validated measure of the impact of psoriasis on chronic quality of life

Conditions: Psoriasis

Summary: objective of the study is to create and validate chronic quality of life (cqol) index that explores habits, career paths and other life choices psoriasis patients make as a result of coping with their disease that may not be impacted by therapy implemented at a given point in time. - the investigators think this data will show that patients who were diagnosed at a young age will have worse chronic quality of life.

as a visible disease, psoriasis can be embarrassing and psychosocially stressful in addition to physically uncomfortable. patients' lives are affected in physical, psychological, social, sexual and occupational aspects. these burdens may cause patients to assume maladaptive habits and coping mechanisms, leading to a downward spiral in functioning within society, prohibiting patients from achieving their highest potential quality of life. the investigators' study goal is to create and validate chronic quality of life (cqol) index that explores habits, career paths and other life choices psoriasis patients make as a result of coping with their disease that may not be impacted by therapy implemented at a given point in time. in creating this questionnaire and validating it the investigators will collect preliminary data. the investigators think this data will show that patients who were diagnosed at a young age will have worse chronic quality of life. in the long run, the investigators will use the cqol index in studies in which patients are treated for psoriasis to determine which treatments can change a psoriasis patient's chronic quality of life. this information will be used to create guidelines for treatment focused on achieving a patient's optimal quality of life. another aspect that the investigators would like to look at is the skin carotenoid levels in the psoriasis population. previous studies showed that psoriasis patients had lower levels of skin carotenoids when compared to healthy volunteers. this observation was not statistically significant perhaps due to a small sample size (21 subjects in the psoriasis group and 35 subjects in the control group). skin carotenoid levels measurement is optional for study subjects.

Eligibility criteria:
inclusion criteria: * able to understand and sign informed consent * able to read english * able to comply with study procedure * male or female of at least 18 years of age * has a diagnosis of psoriasis exclusion criteria: * has any medical condition that might interfere with ability to complete cqol survey

Keywords: psoriasis quality of life
prehospital cpap vs. usual care for acute respiratory failure

Conditions: Respiratory Insufficiency; Hypoxia

Summary: the purpose of this study is to evaluate the effectiveness of continuous positive airway pressure ventilation when applied by paramedics to individuals with severe breathing difficulties in the prehospital setting.

continuous positive airway pressure ventilation (cpap) has been shown to be effective in avoiding endotracheal intubation (eti) for patients with acute respiratory failure in hospital but despite several case series, the effectiveness of the prehospital application of cpap by paramedics has not been studied in a randomized fashion. we performed a prospective, randomized, non blinded trial to determine whether patients in acute respiratory failure treated with cpap in the prehospital setting had lower overall eti rates than those treated with standard care.

Eligibility criteria:
inclusion criteria: * severe dyspnea * respiratory rate \>25 breaths/minute * hemodynamically stable * able to cooperate with ventilatory support measures * assessed by paramedics as being in urgent need of eti and/or manual positive pressure ventilation * a trip destination of the qeii health sciences center or dartmouth general hospital exclusion criteria: * require eti for immediate airway protection * respiratory rate \< 8 breaths/minute * evidence of hemodynamic instability * cardiac ischemia * any chest pain within 3 hours of presentation * valid "do not resuscitate" advanced directive * an inadequate supply of portable oxygen

Keywords: respiratory failure non invasive ventilation prehospital endotracheal intubation continuous positive airway pressure
study of clofarabine and fludarabine drug exposure in pediatric bone marrow transplantation (hct)

Conditions: Hematologic Malignancies; Nonmalignant Diseases; Immunodeficiencies; Hemoglobinopathies; Genetic Inborn Errors of Metabolism; Fanconi's Anemia; Thalassemia; Sickle Cell Disease

Summary: fludarabine and clofarabine are chemotherapy drugs used extensively in bone marrow transplantation. the goal of this study is to determine what causes some children to have different drug concentrations of clofarabine and fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. the hypothesis is that clinical and individual factors cause changes in clofarabine and fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.

fludarabine and clofarabine are nucleoside analogs with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric allogeneic hematopoietic cell transplantation (allohct) to promote stem cell engraftment. this is a single-center, prospective, non-interventional pharmacokinetic (pk) study investigating the clinical pharmacology of combination nucleoside analogue therapy in 24 children undergoing allohct at university of california, san francisco benioff children's hospital. patients would receive clofarabine and fludarabine regardless of whether or not they decide to consent to pk sampling. clofarabine and fludarabine doses will not be adjusted based on pk data. the investigators will apply the combination of a limited sampling strategy and population pk methodologies to determine specific factors influencing clofarabine and fludarabine exposure in pediatric allohct recipients and identify exposure-response relationships. subjects will undergo pk sampling of clofarabine and fludarabine drug concentrations over the duration of combination therapy (3 to 5 days). to evaluate sources of variability impacting clofarabine and fludarabine exposure clinical data will be obtained from the patient's medical chart on each day of pk sampling. to assess exposure-response relationships neutrophil engraftment, treatment-related toxicity, and survival data will be collected through day 100 post-transplant.

Eligibility criteria:
inclusion criteria: * children 0-17 years of age * undergoing allohct for the treatment of malignant or nonmalignant disorder * receiving clofarabine and fludarabine-based preparative regimen exclusion criteria: * any child 7-17 years of age unwilling to provide assent

Keywords: fludarabine clofarabine pharmacokinetics pediatric allogeneic
post hoc analysis and clinical data collection for subjects tested with brain network activation (bna™) technology

Conditions: Healthy; Cognitive Impairment; Neurological Disorder

Summary: the study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and bna scores. the results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

a multi-center study in which subjects that had completed or are completing a bna test with the auditory oddball task (or other tests that will be commercially cleared at any given time), will have the option to complete additional investigational tasks and optional clinical assessments and questionnaire forms. at each site, these additional assessments will be suggested by the site's study doctor or clinician and will be collected with the site's epro device. the study will include up to 10,000 subjects which had completed or will complete a standard bna test. authorized personnel will offer the subjects to participate in the study immediately after testing or contacting subjects that had completed the test in the past. procedure of consent will be performed by the pi or delegates.

Eligibility criteria:
inclusion criteria: * completed or will complete a bna test * able to speak, read and understand english sufficiently to understand the nature of the study, and to allow completion of all study assessments. * willingness to participate exclusion criteria:

Keywords: brain network activation (bna™) eeg cognitive tasks
bendamustine-based combination therapy for pcnsl

Conditions: PCNSL

Summary: this pilot study will i) evaluate the efficacy and the safety of bendamustine-based combination chemotherapy and ii) investigate the pharmacokinetics (pk)of bendamustine in plasma and csf when given as salvage treatment for patients with relapsed or refractory primary central nervous system lymphoma (pcnsl).

a relatively high proportion of patients diagnosed with primary cns lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. based on the demonstrated activity and proposed additive mechanisms of the chemotherapeutic agents included in the bendamustine-based combination regimen, the efficacy and safety of r-b(o)ad will be evaluated for treatment of relapsed/refractory (r/r) primary cns lymphoma. evidence from previous preclinical tissue distribution studies and single agent intravenous drug therapy trials in cns malignancies suggests that bendamustine penetrates brain and tumor tissue, however there are no clinical data available on the pk of bendamustine in the csf. this study will evaluate the pk of plasma and csf drug levels through a population based nonlinear mixed-effects model approach in a r/r pcnsl cohort with the goals to define the currently unknown pk profile of bendamustine in the csf and to further characterize the relationship between plasma and csf drug levels, and the influence of exposure on response to therapy.

Eligibility criteria:
inclusion criteria: 1. pcnsl of diffuse large b-cell lymphoma (dlbcl) with a cns lesion by tissue biopsy 2. age ≥ 19 years old 3. relapsed or refractory pcnsl after frontline combined chemotherapy or radiation 4. ecog performance status 0-2 5. absolute neutrophil count ≥ 1000/ul 6. platelets ≥ 100,000/ul 7. total bilirubin ≤ 1.5 x uln (upper limit of normal) 8. aspartate aminotransferase (ast) ≤ 3 x uln 9. creatinine ≤ 2.0 x uln exclusion criteria: 1. pcnsl of other than dlbcl or t-cell lymphoma with a cns lesion by tissue biopsy 2. any of the following: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception 3. uncontrolled infection 4. therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration 5. persistent toxicities ≥ grade 3 from prior chemotherapy or biologic therapy regardless of interval since last treatment 6. history of thromboembolic episodes ≤ 3 months prior to registration 7. active hepatitis b or c with uncontrolled disease 8. active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment 9. any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study 10. major surgery ≤ 4 weeks prior to registration or have not recovered from side effects of such therapy

Keywords: bendamustine csf pharmacokinetics pcnsl salvage therapy
evaluation of vdd leadless pacing system during exercise

Conditions: Bradycardia; Pacemaker DDD

Summary: the study is a non-randomized, active prospective observational study permitting to report the behavior of micra av pacemaker during an exercise. only patients who were previously implanted with a micra mc1avr01 can be enrolled in the study. exercise test is part of the standard clinical care practice for this patients population during the first year follow-up.

the purpose of this observational study is to obtain additional data on behavior and safety of the micra mc1avr01 during exercise: 1. characterize the atrial detection rate/a4 amplitude by a ventricular micra av (micra mc1avr01) at rest and during exercise 2. characterize the av synchrony percentage provided by the micra av during exercise. 3. confirm the safety of the micra av during exercise only patients who were previously implanted with a micra mc1avr01 can be enrolled in the study. all subjects provide signed and dated consent that he/she is willing and able to comply with the protocol. retrospective patients enrollment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a micra av for whom an exercise test has already been performed. exercise test the micra av permits av synchronous pacing mode up to a maximal sinus rate of 115/min. exercise test will therefore be performed up to a maximal heart rate of 115/min. the test will be stopped by the patient (depending on his/her ability/symptoms such as: fatigue, dyspnea, leg pain,..) or by the cardiologist if a maximal heart rate of 115 beats per minute is reached.

Eligibility criteria:
inclusion criteria: * patients previously implanted with a micra mc1avr01 * signed and dated consent (patient confirms that he/she is willing and able to comply with the protocol) * patient is physically able to perform an exercise test (cycle test). retrospective patients enrolment is allowed to facilitate a more rapid performance assessment in patients previously implanted with a micra av for whom an exercise test has already been performed. co-enrolment in the micra av post-approvals study is allowed. exclusion criteria: - frail patient unable to perform an exercise test (cycle test).

Keywords: leadless pacemaker micra