Kornimate/medical-research-clean huggingface dataset:
long-term follow-up after adoptive transfer of genetically modified cell products

Conditions: Relapsed Hematologic Malignancy; Refractory Hematologic Malignancy

Summary: human gene therapy products are designed to achieve therapeutic effect through genetic modifications of human cells using retroviral or lentiviral vectors, resulting in permanent or long-acting changes in the human body. with this genetic modification comes risk of undesirable adverse events. due to this risk, the food and drug administration (fda) and the center for biologics evaluation and research (cber) require long-term follow-up (15 years) of participants that receive investigational gene therapy products that meet defined criteria. this protocol will provide a mechanism by which to appropriately monitor participants that have received a genetically modified cellular product on a st. jude initiated study.

this is a prospective, longitudinal, non-therapeutic study which includes routine assessment for long-term effects, as per fda guidelines, after receipt of a gene therapy product on a st. jude investigator-initiated clinical trial. there will be no group assignment, no use of placebo groups and no use of control subjects. participants will enroll on this long-term follow-up study after completion of necessary follow-ups on the interventional clinical trial on which they received treatment with a genetically modified product, to complete a total of 15 years of follow-up post infusion. assessments will include routine history, physical exam and blood sample procurement, in accordance with fda guidance, for 15 years post infusion of the gene therapy product. study evaluations may be performed by a local provider in conjunction with the st. jude research team. in addition, standard clinical data related to the subject's prior gene therapy treatment will be reviewed. the data may include, but is not limited to: patient demographics, disease history, on-going disease status updates, gene therapy product and treatment characteristics, patient clinical status, post gene therapy disease directed therapies, relapse and death

Eligibility criteria:
inclusion criteria: * receipt of a genetically modified cell product on a st. jude investigator-initiated study within the prior 15 years. exclusion criteria: * inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.
hypertonic saline and terlipressin for sepsis-associated hypotension

Conditions: Septic Shock; Sepsis-associated Hypotension

Summary: in hypotensive septic patients with controlled source, an hemodynamic management protocol including hypertonic saline (hs)and terlipressin improves mod (multiple organ dysfunction) score by at least 3 points compared to the use of physiologic saline and norepinephrine. the appropriate design for this trial would be factorial. for the time being, will consider de intervention as a whole unit for this pilot study. in the future an appropriately sized factorial multicentric study shall be necessary. other goals of the pilot study: 1. hs restores preload parameters adequately 2. hs associated with terlipressin normalizes blood pressure in septic shock 3. hs associated with terlipressin maintains plasma sodium levels 130-155meq/l 4. there is an inverse relationship between plasma sodium and procalcitonin levels 5. hs increases plasma levels of vasopressin (avp) 6. hs rises levels of cortisol but not of adrenocorticotropic hormone (acth)


Eligibility criteria:
inclusion criteria: * criteria of sirs: at least 2 of 4: * temperature \> 38 °c or \< 36 ° c * more than 90 bpm heart rate * respiratory rate more than 20rpm or paco2 less than 32 mm hg or patient in mechanical ventilation * less than 4000/ mm³ or more than 12000/mm³, or more than 10% leukocyte bands (immature) * septic source known demonstrated (or at least of high probability) and controlled (if it is controllable) * hematocrit 25% or higher and/or hemoglobin 8 g/dl or higher. if necessary, transfuse rbcs to meet this criteria * map less than 70 mm hg. note there is no requirement for adequate preload evidence exclusion criteria: * hypernatremia at base-line of 155 meq/l or greater hyponatremia at base-line less than 130meq / l * prior endocrine disease affecting to the adrenal-pituitary axis. * intracranial hypertension, brain tumor, seizures, head trauma * coronary artery disease active over the past year; or evidence of "myocardium at risk" by exercise stress test, pharmacological or positive gammagraphy last year without intervention * pregnancy * liver disease child c, end-stage-renal-disease * under the age of 18 * patients with order "do not resuscitate" or with minimal chances to survive
mindfulness, emotional well-being, and sleep quality

Conditions: Stress, Psychological; Sleep

Summary: the purpose of this study is to determine whether participating in a mindfulness-based stress reduction (mbsr) program increases mindful attention and awareness, and whether anticipated changes in mindfulness relate to improved emotional well-being, sleep quality, physical symptoms of stress, sense of spirituality, and quality of life following mbsr.

this study will be conducted among men and women participating in 8-week mindfulness-based stress reduction (mbsr) classes at duke integrative medicine in durham, north carolina. the central hypothesis of this nih-funded clinical trial (k99 at004945, pi: greeson) is that mindfulness meditation training is associated with increased levels of mindfulness and improved cognitive-emotional functioning that, together, are associated with reduced psychological distress, improved sleep quality, and decreased stress-related physical symptoms, including muscle tension, headache, and gastrointestinal complaints. this study is designed to examine psychological mechanisms that may explain individual differences in mbsr outcomes. this knowledge is important because it will help us better understand who is most likely to benefit from mindfulness meditation training, and why. the results from this study are expected to elucidate mechanisms underlying the mental and physical health benefits of stress reduction, which can help guide clinicians in referring the most suitable patients to local mbsr programs.

Eligibility criteria:
inclusion criteria: * enrollment in a self-pay mbsr course at duke integrative medicine * must be able to speak and read english exclusion criteria (apply to duke's mbsr program, and thus to the research study): * active substance abuse/dependence * severe mental illness * difficulty being redirected to task in a group setting

Keywords: mindfulness meditation stress rumination emotion regulation sleep quality spirituality quality of life
citrulline for children undergoing cardiopulmonary bypass surgery

Conditions: Cardiovascular Diseases; Heart Diseases; Heart Defects, Congenital

Summary: this study will determine the pharmacokinetics and safety of intravenous citrulline given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.

background: increased pulmonary vascular tone (pvt) can complicate the postoperative course of the following six surgical procedures for congenital heart defects: 1) unrestrictive ventricular septal defect (vsd) repair; 2) atrioventricular septal (avsd) repair; 3) arterial switch procedure for transposition of the great arteries (tga); 4) norwood i procedure; 5) bidirectional glenn shunt procedure; and 6) fontan procedure for single ventricle lesions. pvt is partially controlled by nitric oxide (no). arginine, the precursor to no, is a product of the urea cycle. preliminary data have been presented regarding 169 infants and children who have undergone one of the six previous surgical procedures. it was found that urea cycle function and plasma arginine levels were significantly decreased in all patients. furthermore, patients with increased pvt had significantly lower arginine levels compared to patients with normal pvt. finally, a genetic single nucleotide polymorphism (snp) in the rate limiting urea cycle enzyme (carbamyl phosphate synthetase i \[cpsl t1405n\]) appeared to affect postoperative plasma arginine levels and pvt. the hypothesis is that genetic polymorphisms in the rate limiting urea cycle enzyme cpsl, and other important enzymes in the urea cycle, influence the availability of no precursors. it is further hypothesized that perioperative enhancement of urea cycle function with the key urea cycle intermediate (citrulline) will increase plasma arginine and no metabolites, and prevent elevations in pvt. design narrative: this phase i/ii study will determine the pharmacokinetics and safety of three doses of intravenous citrulline that will be given to children undergoing cardiopulmonary bypass for the correction of congenital heart defects.

Eligibility criteria:
inclusion criteria: * undergoing cardiopulmonary bypass via one of the following surgical procedures: 1. avsd repair 2. vsd repair 3. bidirectional glenn 4. modified fontan 5. arterial switch * parents willing and able to sign consent exclusion criteria: * pulmonary artery or vein abnormalities not being addressed surgically * preoperative requirement for mechanical ventilation or intravenous inotrope support * any condition that might interfere with study objectives
pilot deployment of epna into epic ehr

Conditions: Pneumonia

Summary: intermountain health has developed a electronic decision support tool to help doctors provide the best care for pneumonia. the purpose of this study is to enhance the existing tool (called epneumonia (electronic pneumonia) or epna) so that it can be used at other institutions, and to test deployment of the tool at another institution's hospitals.

this study as funded by the ahrq (agency for healthcare research and quality) involves making the current epna system a "smart on fhir" compatible application that will enable the same core software and processes to work across the cerner and epic electronic health record platforms. the investigators will then engage with emergency department providers and patients to improve user centered design, considering clinician preferences and feedback for use as well as patient needs for information. finally, the investigators will evaluate the feasibility and acceptability via a pilot implementation trial of the interoperable epna platform at two vanderbilt affiliated hospitals.

Eligibility criteria:
inclusion criteria: for the baseline database and assessment of clinical outcomes, all data will be pulled from the epic clarity data warehouse. * 2500 patients that presented to the vanderbilt and wilson county eds who are \>= 18 years old will be identified by icd-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes for the baseline database. * an additional 2500 patients that presented to the vanderbilt and wilson county eds who are \>= 18 years old will be identified by having had conventional pa (posteroanterior) and lateral or portable cxrs (chest x-rays), independent of icd-10 codes. * during the one year pilot trial, patients seen in the 2 eds, who are \>= 18 years old will be identified by icd(international classification of diseases)-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes (estimated to comprise 1800 patients). exclusion criteria: for all above patients: 1. patients seen with a history of recent trauma. 2. subsequent episodes of pneumonia from the same patient within the study period. 3. patients directly admitted to hospice/comfort care. 4. patients admitted to a non-study hospital for further care. 5. patients transferred from outside hospitals. for the groups selected by icd-10 pneumonia codes, an additional exclusion is: • patients without radiographic evidence of pneumonia or with clear radiographic evidence for an alternative diagnosis.

Keywords: decision support
nurse-led quality of life study-phase i

Conditions: Quality of Life

Summary: the purpose of this study is to pilot test a brief, population-specific nurse-led, quality of life (qol) intervention with early phase cancer clinical trial (ep-ct) participants. the name of the intervention used in this research study is: -nurse-led quality of life intervention (comprised of nurse-patient relationship, assessment and monitoring of participant qol, and interdisciplinary team meetings led by the crn (clinical research nurse).

this is a single-site study evaluating the feasibility and acceptability as well as patient-reported and clinical outcomes of a nurse-led, quality of life intervention with ep-ct participants. the research study procedures include obtaining consent to participate, meeting with research nurses monthly for three months, completing questionnaires, and an interview with the study staff at the end of the study. participation in this research study is expected to be for a total of six months. it is expected that about 35 people, 25 caregivers, and 10 clinicians will take part in this research study. the oncology nursing foundation is supporting this research study by providing funding.

Eligibility criteria:
patient inclusion criteria: -\> 18 years of age. * adults with cancer enrolled on an ep-ct in the termeer center at massachusetts general hospital. * able to read and respond to questions in english. caregiver inclusion criteria: * a relative or friend of the eligible patient whom the patient identifies as being involved in their medical care. -\> 18 years of age. * verbally fluent in english. clinician inclusion criteria: * clinician must be an oncology nurse. * crn for a minimum of 18 months. * fulltime employee in the termeer center.

Keywords: quality of life
double or single dose sirolimus-eluting stents in diabetic patients with de novo coronary artery lesions

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting bx velocity stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting bx velocity™ stents.


Eligibility criteria:
inclusion criteria: 1. the patient must be minimum 18 years of age; 2. patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months; 3. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii-iii) or patients with documented silent ischemia; 4. treatment of one lesion in a native coronary artery. the treated lesion will be the one with the highest % diameter stenosis by visual estimate. additional study stents may be used for procedural complications such as dissections. multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. if other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion; 5. the target vessel is 2.5 mm and 3.5mm in diameter (visual estimate); 6. the target lesion is \<30 mm in length (visual estimate) located in a native coronary artery; 7. target lesion stenosis is \>50% and \<100% (timi i) (visual estimate); exclusion criteria: 1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck\>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment; 2. patients admitted for treatment of diabetic ketoacidosis \> 2 times in the past six months (brittle diabetics); 3. ejection fraction 30%; 4. impaired renal function (creatinine \> 2.0 mg/dl);
flibanserin randomized withdrawal trial in pre-menopausal women

Conditions: Sexual Dysfunctions, Psychological

Summary: to estimate the duration of efficacy with continued treatment of double-blind flibanserin or placebo over twenty-four weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. women over 18 and pre-menopausal 2. fsds-r above 14 3. willingness to try to have sexual activity at least monthly 4. willingness to use an electronic diary daily 5. stable, monogamous, heterosexual relationship for at least one year 6. medically acceptable method of contraception exclusion criteria: 1. clinically relevant conditions which might interfere with the patient's abil ity to participate in the trial 2. specified medications 3. sexual function affected by medication 4. drug dependence or abuse 5. sexual partner needing treatment 6. peri-menopause or menopause (surgical or otherwise) 7. pregnancy 8. pelvic inflammatory disease 9. major depressive episode 10. significant ecg abnormalities 11. significant neurologic findings 12. significant gi, hepatic, cardiovascular, renal, hematologic, immunologic or respiratory findings 13. uncorrected thyroid or endocrine disease 14. uncontrolled glaucoma
a randomized trial of vitamin d to reduce respiratory infection

Conditions: Respiratory Infection

Summary: the goal of this study is to assess the effectiveness of vitamin d in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. a cohort of children between the ages of 3 and 17 years from the thanh ha commune, thanh liem district, ha nam province, vietnam will be randomized to either weekly vitamin d supplements or placebo. participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by rt-pcr.


Eligibility criteria:
inclusion criteria: * between the ages of 3 and 17 * residing in thanh liem district, ha nam province, vietnam exclusion criteria: * born prematurely at less than 32 weeks gestation * any chronic illness (except asthma) * currently using medication known to interfere with vitamin d metabolism * children with a sibling participating in the study

Keywords: human influenza children
relief of symptoms of post-traumatic stress for victims of gun violence

Conditions: PTSD; Stress, Psychological; Gunshot Wound

Summary: to test the hypothesis that adult individuals who are victims of gun violence will have decreased symptoms of post-traumatic stress after an individual-level intervention with the screening and tool for awareness and relief of trauma (start).

in response to the lack of targeted mental health intervention for gunshot wound survivors, the screening and tool for awareness and relief of trauma (start) was developed for patients that come from communities with sustained and persistent trauma. it consists of six screening questions adapted from the validated primary care ptsd screen,\[30\] with input from focus groups, surveys and in-depth interviews with victims of violence and in particular, boys and young men of color. start has been shown to be effective at decreasing symptoms of ptsd in a one-month follow-up, but it has not been piloted on recently injured victims of gun violence specifically nor has it been tested in a randomized control trial design. a better understanding of the utility of this tool and others like it in victims of violent crime for relief of symptoms of post-traumatic stress and prevention of ptsd would contribute to the larger body of literature on ptsd prevention for victims of gun violence while simultaneously addressing a major need in this community.

Eligibility criteria:
inclusion criteria: * survivors of gunshot wound presenting to the emergency room and/or admitted as inpatient that are eligible for the violence prevention and outreach program (vpop). exclusion criteria: * patients with severe traumatic brain injury * children under the age of 18 * patients otherwise unable to give consent * non-english speaking patients * victims of sexual assault * patients with history of a severe mental illness and/or those already undergoing treatment for a mental illness by a licensed professional.
infrared for peripheral venous catheterization in the critically-ill

Conditions: Peripheral Venous Catheterization

Summary: peripheral venous catheterization is a fundamental part of the management of critically-ill patients, especially for administration of intravenous emergency treatments. in general, it is preferred to central catheterization whenever possible, since it is less invasive, achievable immediately by the nurse, and responsible for fewer complications. venous access difficulties are frequent in critically-ill patients. among tools proposed to improve the practice of peripheral catheterization, ultrasound and infrared illumination are the most studied, the latter being simpler. infrared illumination has never been evaluated in intensive care. however, the delay or failure of peripheral catheterization is highly detrimental in the context of resuscitation as it may delay or impede appropriate management of vital emergencies. our study will focus on the peripheral venous catheterization of the upper limbs, as these are the reference site for this technique the objective is to evaluate the interest of infrared illumination (accuvein av500®) for the primary success (first puncture) of peripheral venous catheterization of the upper limbs in patients with resuscitation at risk of catheterization venous difficult. it is a comparative, superiority, prospective, multicenter, randomized, controlled, open-label, phase iii trial. subjects will be divided into two groups with a 1: 1 ratio. nurses at participating centers will be trained for the use of the device prior to the start of the study; the use of the device is singularly easy and intuitive.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; hospitalization in intensive care; * need for a peripheral venous catheter; * risk of difficult peripheral venous catheterization. in practice, this risk will be considered present if it is impossible to palpate and / or visualize the upper end of the target vein and / or if the estimated vein diameter is smaller than 2mm. this definition is derived from the a-diva score (loon faj van et al3). * affiliation to the social security exclusion criteria: * patient who has already been enrolled in the icare study during the current hospitalization; * refusal of patient's participation

Keywords: venous access illumination, infrared critically-ill catheterization