Kornimate/medical-research-clean huggingface dataset:
tcr alpha/beta and cd19-deplete haplo-hsct

Conditions: Pediatric Patients; Hematologic Malignancy; Other Hematologic Condition

Summary: this is an open label, interventional, non-randomized, phase ii trial of tcr alpha/beta and cd19-depeleted allogeneic hct in pediatric patients with hematologic disease.

this is a single-site, open label, interventional, non-randomized, phase ii trial of tcrαβ/cd19 deplete allogeneic hct as donor source and sole gvhd prophylaxis in pediatric patients with either malignant or non-malignant hematologic disease who are eligable for allogeneic hct, but lack a hla-matched sibling donor.

Eligibility criteria:
inclusion criteria: 1. age 31 days to \<30 years 2. have a malignant or non-malignant hematologic disease, defined as disease resulting from abnormal function of a cell of the hematopoietic stem cell lineage, that could benefit from an allogeneic hct. examples include acute and chronic leukemias, myelodysplastic syndrome, lymphoma, severe acquired and congenital cytopenias/marrow failure, white blood cell abnormalities, red blood cell abnormalities, and platelet abnormalities. 3. clinical remission for patients with acute leukemia (mds/aml excluded) or lymphoma 4. lack a healthy and willing hla-identical related donor, with the exception of patients with fa who will be eligible with a willing hla-identical related donor given the standard use of t-cell depletion in matched sibling donor hct in fa 5. have a related or an unrelated donor who meets the donor selection criteria, is healthy, willing, and able to receive gcsf with or without plerixafor, and undergo apheresis through placement of catheters in the antecubital veins or a temporary central venous catheter 6. able to give informed consent if ≥ 18 years, or with legal guardian capable of giving informed consent if \< 18 years 7. provision of signed and dated informed consent form exclusion criteria: 1. uncontrolled, active infection at time of hct 2. hiv positivity 3. cardiac ejection fraction \<45% 4. creatinine clearance \<60 ml/min/1.72 ml 5. pulmonary diffusion capacity (adjusted for hemoglobin), fev1, or fvc \<60% of predicted or an o2 saturation \<94% on room air if unable to perform pulmonary function testing 6. serum alt \>5x upper limit of normal or bilirubin \>2 7. performance score (lansky or karnofsky) \<50 8. pregnant or lactating females, as many medications necessary for a successful hct are potentially harmful to unborn babies and infants.

Keywords: donor granulocyte stimulating factor (gcsf) apheresis
evaluation of the sensitivity of a transdermal device to monitor the sweat alcohol concentration

Conditions: The Sweat Alcohol Concentration

Summary: a non invasive transdermal sensor device was developed by the im2np laboratory to determine the presence of vapor of alcohol in insensible perspiration. one of possible application would be a continuous and non invasive monitoring of drinking behavior. to investigate the validity of this method, it's necessary to compare transdermal alcohol concentrations results obtained by this new device with blood alcohol concentrations and breath alcohol concentrations provided by reference methods. the purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion.


Eligibility criteria:
inclusion criteria: * male or female 18-40 years, age-matched (+ 3 years) * caucasian * bmi: 19 to 28 kg/m2 * no smoking or light smoker (\<5 cig/d) * moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience exclusion criteria: * subjects with addiction to toxic or alcohol (mini questionnaire) * positive individuals in search of drugs and toxic * anxiety or depressive subjects (iasta questionnaires and bdi)
prophylaxis of postoperative nausea and vomiting after cardiac surgery

Conditions: Postoperative Vomiting; Postoperative Nausea; Postoperative Emesis

Summary: to investigate the role of postoperative nausea and vomiting risk factors assessment after cardiac surgery. we designed a randomized controlled study comparing standard care (no risk factor assessment and no intervention) with prophylaxis of postoperative nausea and vomiting after cardiac surgery in high risk patients. prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors (if risk score is over 2) in the intervention arm.

patients planned to undergo cardiac surgery were screened for inclusion. inclusion criteria are as follow: non emergent cardiac surgery; age \> 18 years; affiliation to french social security; approval of participation to the study; at the exclusion of: pregnancy ; contra indication to antiemetics; chronic usage of antiemetics; and emergent or complicated surgery. risk factors for postoperative nausea and vomiting were collected and patients were randomized by cluster into two arms. control: no prophylaxis whatever risk score is. postoperative nausea and vomiting risk factors were not available for practicians. intervention: preoperative collection of postoperative nausea and vomiting risk factors available for practicians. prophylaxis if risk score is over 2. prophylaxis of postoperative nausea and vomiting by betamethasone (4mg) and/or droperidol (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm. all outcomes are assessed at 48 hours of surgery: primary: occurrence of postoperative nausea or vomiting secondary: number of postoperative nausea and vomiting with visual assessment scale (vas), and antiemetics used for treatment; postoperative pain (vas) with number of analgesics used; postoperative discomfort (vas). safety data: side effects and qt corrected intervals.

Eligibility criteria:
inclusion criteria: * non emergent cardiac surgery * age \> 18 years * affiliation to french social security * approval of participation to the study exclusion criteria: * pregnancy * contra indication to antiemetics * chronic usage of antiemetics * emergent or complicated surgery

Keywords: cardiac surgery corticoids droperidol antiemetics postoperative vomiting postoperative nausea postoperative emesis prophylaxis
effects of low level laser therapy (808nm) on muscle performance of young women submitted to physical training

Conditions: Healthy

Summary: the study hypothesis is an increase in muscle performance and a higher aerobic adaptation of young women submitted to chronic endurance training program associated to low level laser therapy when compared to chronic aerobic training alone.

the study assessed women muscle performance in isokinetic dynamometry, ventilatory parameters such as ventilatory threshold, vo2peak, vo2max, ventilation. maximal load in cycle ergometer test (balke's protocol), borg scale and heart rate were assessed too.

Eligibility criteria:
inclusion criteria: * healthy young women volunteers * women with a beginner or moderately trained pattern of physical activity * body mass index (bmi) between 18 and 25kg/m2 exclusion criteria: * previous injury to the femoral quadriceps or hamstrings muscles (within 6 months prior to study) * osseous or articular disorder in the lower limbs * cardiovascular system disorders or systemic disease

Keywords: low level laser therapy muscle performance fatigue index endurance training ventilatory threshold vo2max vo2peak
pathogenesis of atypical femur fractures on long term bisphosphonate therapy

Conditions: Osteoporosis; Atypical Femoral Fractures; Prodromal Bone Deterioration

Summary: the purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as alendronate, risedronate, ibandronate, and zoledronate. in addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments...i.e., "the right treatment for the right patient for right duration."


Eligibility criteria:
inclusion criteria: * women with a diagnosis of osteopenia or osteoporosis as defined by bone mineral density (bmd) * patient treated with bps for \>5 years * patients treated with non-bp anti-fracture medications such as... * estrogens, raloxifene, calcitonin * treatment naive patients exclusion criteria: * all men regardless of bmd result * patients with obvious traumatic aff * patients with normal bmd (better than -1.0 t-score at spine or proximal hip) * unable to take tetracycline * previous use of teriparatide * known allergies to the following: * tetracycline antibiotics * meperidine * midazolam
acquiring convalescent specimens for covid-19 antibodies

Conditions: COVID-19; Coronavirus Infection; Corona Virus Infection

Summary: blood samples from participants who have recovered from covid-19 infection will be obtained and studied. the goal of the research is to identify antibodies that have been generated by the patient to fight the covid-19 infection. by identifying the most effective antibodies, scientists can make specific antibodies to use to prevent future coronavirus outbreaks or to treat patients with severe disease.

coronavirus disease (covid-19), an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2), has caused over 1,273,712 infections and over 69,458 deaths worldwide. columbia university irving medical center/newyork-presbyterian (cuimc/nyp) has assembled a team of committed virologists, molecular biologists, chemists, and technologists to address this emerging threat. monoclonal antibodies have become great additions to our therapeutic arsenal, primarily in treating cancer or autoimmune diseases. recently, the use of monoclonal antibodies in combating infections such as respiratory syncytial virus and hiv have also become clear. in recent years, advanced cell sorting and sequencing technologies have been utilized to identify neutralizing antibodies from human b cells. this protocol will outline our approach to obtaining blood specimens from participants who are recovering from covid-19 infection. potential participants will be referred by health care providers from within the cuimc/nyp system and from outside institutions. if the potential participant agrees to be contacted, study staff will call them to review the informed consent, eligibility criteria and study procedures, and set up a study visit for blood draw. monoclonal antibodies that could potently neutralize 2019 novel coronavirus (2019-ncov) and related coronaviruses will be isolated from these specimens. candidate monoclonal antibodies will then be optimized and evaluated for therapeutic potential. the ultimate goal would be able to produce a monoclonal antibody that could confer protection during an outbreak or be utilized to treat patients with severe covid disease.

Eligibility criteria:
inclusion criteria: * age 18 to 65 (inclusive) * confirmed covid-19 infection by a fda-approved molecular based assay (including those under emergency use authorization) of respiratory or blood specimens; * if symptomatic with covid-19, must have evidence of improvement of symptoms and a duration of at least 4 weeks from the onset of symptoms to day of enrollment; * if asymptomatic, must have a duration of at least 4 weeks from first positive molecular based covid-19 assay to day of enrollment exclusion criteria: * \ 65 years old * no confirmed diagnosis of covid-19
immunogenicity and safety of dtpa-hbv-ipv/hib compared to dtpa-ipv/hib and hbv administered concomitantly

Conditions: Hepatitis B; Diphtheria; Haemophilus Influenzae Type b (Hib); Poliomyelitis; Pertussis; Tetanus

Summary: this study will assess the immunogenicity of glaxosmithkline (gsk) biologicals' (formerly smithkline beecham biologicals') dtpa-hbv-ipv/hib (infanrix hexa™) vaccine compared to the separate administration of dtpa-hbv-ipv (infanrix™ penta) and hib (hiberix™) vaccines administered at 3 and 5 months of age.


Eligibility criteria:
inclusion criteria: * a male or female between 12 and 16 weeks of age at the time of the first vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. * administration of chronic immunosuppressants or immune-modifying drugs during the study period. * administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose. * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b, polio and/or hib diseases. * history of/or intercurrent diphtheria, tetanus, pertussis, hepatitis b, polio and/or hib disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin b. * major congenital defects or serious chronic illness. * progressive neurological disorders. * administration of immunoglobulins and/or any blood products since birth and during the study period. * acute febrile illness at the time of planned vaccination.

Keywords: infants combined vaccine dtpa-hbv-ipv/hib dtpa-ipv/hib safety immunogenicity hbv
the differences between gonadal and extra-gonadal malignant teratomas

Conditions: SEER Database

Summary: a tumor comprising of different types of tissues (such as hair, muscle, bone, etc.) is known as a teratoma. it is a type of germ cell (cells that make sperm or eggs) tumor. when these germ cells have rapid cancerous growth, then such a teratoma is called a malignant teratoma. we have studied the differences between gonadal and extra-gonadal malignant teratomas and the effects of chemotherapy in both genders. methods: the samples of 3799 male and 1832 female patients with malignant teratoma samples, between the ages of 1 and 85+ years, were selected from the years 1973 to 2014. trends in incidence, estimated prevalence, incidence rates, and frequency were calculated in gonadal and extra-gonadal tumors with age adjustment. the fiveyear observed, expected, and relative survival rates were analyzed to study the prognosis.


Eligibility criteria:
the registry used in our study was the seer 9 registries custom data (with additional treatment fields), nov 2016 submission (1973-2014) \ - linked to county attributes -total united states, 1969-2015 counties, national cancer institute, dccps (division of cancer control and population sciences), surveillance research program, released april 2017, based on the november 2016 submission.
vascular risk after kidney transplantation

Conditions: Cardiovascular Disease; Chronic Kidney Disease; Diabetes; Vitamin D Deficiency; Hyperparathyroidism

Summary: hypothesis: nontraditional risk factors, such as inflammation, vitamin d deficiency, elevated pth, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant. the purpose of this study is to evaluate which traditional and nontraditional cardiovascular disease risk factors best predict progression of cardiovascular disease (cvd) using carotid intima media thickness performed by ultrasound, in kidney transplant patients.

cardiovascular disease remains the greatest cause of mortality after kidney transplant. traditional risk factors, such as hypertension, diabetes, hyperlipidemia and smoking, contribute to vascular disease after transplant, but nontraditional risk factors may play a bigger role in vascular disease progression in this setting. this observational study will evaluate nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. the study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness

Eligibility criteria:
inclusion criteria: * kidney transplant more than 6 months ago * 19 years or older exclusion criteria: * estimated gfr \<30 * previous small bowel, or lung transplant * pancreas transplant less than 6 months ago * cancer or any condition that would change weight dramatically in the near future such as malabsorption. * willing to return for testing annually for 3 years * women who are pregnant

Keywords: kidney transplant vascular risk inflammation diabetes insulin resistance chronic kidney disease
influence of tracheostomy on lung deposition in spontaneously breathing patient

Conditions: Tracheostomized Patients

Summary: to compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.


Eligibility criteria:
inclusion criteria: * patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery exclusion criteria: * allergy to aminoglycosides * patients who received aminoglycosides treatment less than one month prior the surgery * pectoralis major flap reconstruction * latissimus dorsi flap reconstruction

Keywords: nebulization aerosol nebulizer tracheostomy
video assisted informed consent for lortab to improve patient satisfaction and knowledge

Conditions: Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit

Summary: in order to compare two different forms of patient education; patients who receive lortab medication or prescription during their ed visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. after education, patient completes a survey, estimated to take 5 minutes to complete.

the purpose of this study is to compare different methods of teaching patients about their prescription medicines. it is possible that certain teaching methods are better than others at educating patients. patients who receive lortab medication or prescription during their ed visit and agree to the study are randomized to receive either standard patient education (from healthcare provider) or watch a 3 minute video. after the medication teaching has been provided the patient is given the medicine and a asked to complete a ten-question survey. this takes approximately five minutes and asks the patient to rate the quality of the information received.

Eligibility criteria:
inclusion criteria: * non-critical emergency room patients being prescribed lortab * age 18 year or older exclusion criteria: * emergency room patients not receiving lortab as their first prescribed medication * age less than 18 years
nurturing and quiet intervention: neuron-qi

Conditions: Neurodevelopment

Summary: the current state of knowledge reveals that the development of the brain of preterm infants is influenced by specific neonatal experiences during hospitalization, such as environmental sensory stimulation (light and noise), as well as physical and emotional proximity to mothers. however, there is a lack of evidence regarding the benefits that could be associated with the combination of care interventions to improve the health outcomes of preterm infants and their mothers, and in particular the development of the brain of infants during their hospitalization in the neonatal unit. the aim of this pilot study is to assess the feasibility and acceptability of a developmental care intervention including periods of nurturing between mothers and their infant (skin-to-skin contact and auditory stimulation) to promote physical and emotional proximity and a quiet period (controlled light and noise levels and olfactory stimulation in incubators) and to estimate the effect of this intervention on infants' neurodevelopment as well as on maternal stress and anxiety.


Eligibility criteria:
inclusion criteria: infants: - born between 26 and 316/7 wga. mothers * agree to do 4 ssc sessions/week with a 15-minutes period of auditory (reading) stimulation; * express breast milk for their infant; * speak, read, or write french or english. nurses: * have at least 6 months of work experience in a nicu; * speak and read french or english. exclusion criteria: infants: * have birth defects or genetic disorders; * have an intraventricular hemorrhage \> grade ii; * receive nasal respiratory support; * have been transferred from another hospital. mothers: * are \<18 years of age; * had a multiparous birth; * have a physical condition that does not allow ssc; * abuse substances or alcohol; * do not intend to breastfeed or give breastmilk.

Keywords: developmental care preterm infants mothers pilot study
assessment of different indices in prediction of noninvasive ventilation failure in patients with acute respiratory failure

Conditions: Non-invasive Ventilation

Summary: this study will use different indices for prediction of niv failure in arf patients evaluation of hacor score and rox index for early prediction of niv failure in patients with arf. study value of diaphragmatic dysfunction assessed by ultrasound as tool for prediction of success of niv in arf patients. compare clinical significance of these scoring systems between hypoxemic and hypercapnic rf

noninvasive ventilation (niv) is a useful and safe method to improve gas exchange in patients with acute respiratory failure (arf) of different etiologies. niv reduces the work of breathing, improves arterial oxygenation and alveolar ventilation. it is associated with improved survival in the acute care setting (cabrini l 2015) when compared to conventional oxygen therapy. as niv offers several major advantages over invasive ventilation (e.g., preserving the ability to swallow, cough, and communicate verbally), it is widely used to avoid intubation. although niv nowadays is frequently used, its failure rate remains high (25-59%), indicating that not all patients benefit from this treatment. there is an association between the unsuccessful niv and the poor outcome has been suggested. among patients who experience niv failure, either premature or delayed niv discontinuation further increases mortality. thus, identifying the predictors of niv failure is crucial because of the strong link between failure and poor outcomes. so, researchers woke to make scoring systems that may predict niv failure, as hacor and rox indices. recently, ultrasonography (us) of the diaphragm as a bedside method is used for evaluation of diaphragmatic function and predicting failure of niv in acutely ill patients. up till now there is limited research to support significance of different indices for prediction of niv failure and need for invasive mechanical ventilation (imv).

Eligibility criteria:
inclusion criteria: 1. patients with acute hypoxic respiratory failure who need noninvasive ventilation. 2. patients with acute hypercapnic respiratory failure who need noninvasive ventilation. exclusion criteria: 1. age \< 18 years old. 2. patients with unconsciousness, severe hemodynamic instability, unable to fit mask (recent facial surgery, trauma, or deformity), inability to protect the airway or clear respiratory secretions or any other contraindication of niv. 3. neuromuscular disease or chest wall deformities. 4. pregnancy. 5. niv intolerance. 6. severe obesity with body mass index (bmi)≥35 kg/m2