Kornimate/medical-research-clean huggingface dataset:
study of human central nervous system (cns) stem cell transplantation in cervical spinal cord injury

Conditions: Cervical Spinal Cord Injury; Spine Injury; Cervical Spine Injury

Summary: this study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.


Eligibility criteria:
inclusion criteria: * male or female subjects age 18 to 60 years. * traumatic cervical spinal cord injury (csci) with c5-c7 motor levels according to the international standards for neurological classification of spinal cord injury (isncsci) as determined by the investigator. * american spinal injury association impairment scale (ais) grades b or c * minimum of 12 weeks post-injury prior to screening exclusion criteria: * history of penetrating sci. * mri evidence of complete spinal cord interruption . * evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma. * prior participation in another investigational study within 90 days prior to screening. * previous organ, tissue, bone marrow transplantation, or gene transfer * history of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy

Keywords: spine injury trauma spine injury cervical spine injury cervical spine stemcells transplantation
prematurity at the limit of viability

Conditions: Very Preterm Maturity of Infant

Summary: advancements in perinatal care have significantly improved the survival of extremely premature infants, establishing a viability threshold below 25 weeks' gestational age (ga). however, management at the limit of viability poses ethical and decision-making problems for health-care professionals. they grapple with the delicate balance between potential survival and long-term disabilities. these decisions, as well as the information given to families, are based on knowledge of the prognosis as assessed by national and international epidemiological studies. healthcare professionals rely on population-based estimations but face discrepancies in predicting outcomes because there are significant variation depending on perinatal center and country where infants are hospitalized. in the large french epidemiological study, 9,6% of livebirths included were born at 22-25 wks and only 38% survived. in the neonatology department of the croix rousse, these infants have been actively cared for for many years, which has allowed the development of specific skills that are essential for the proper management of these very high-risk patients. furthermore, epipage 2 included data from centers where perinatal management was probably not very active at these extreme ages. it results in worse neonatal outcomes as evaluated at the national level than outcomes data evaluated at the neonatal intensive care unit of croix-rousse hospital. using data from epipage 2 study for clinical decision could lead to avoid active care at the for some infants at the limit of viability it is needed to obtain complete evaluation of neonatal outcomes of infants hospitalized at the croix-rousse hospital, so that clinicians may rely on actualized data related to the practices in their perinatal center. it is also needed to compare outcomes with data from large national and international cohorts, to identify and quantify differences. data about later neurodevelopment outcomes, at 2 years, are also needed as it can taken in consideration in decision-making process.


Eligibility criteria:
inclusion criteria: * infants born between 22 and 25 weeks gestational age * infants hospitalized at the tertiary care neonatal unit of croix-rousse hospital * infants born between january 2010 and december 2019 exclusion criteria: - none

Keywords: prematurity morbi-mortality neurosensory development
impact of perinatal exposure to non-caloric sweeteners on food preferences and weight gain in the first year of life

Conditions: Exposures Associated With Pregnancy, Delivery and Lactation

Summary: during last years, non-caloric sweeteners (ncss) have been increasingly incorporated into foodstuffs in replacement of sucrose in chile. this situation has reached a point where it is currently difficult to find sugary foods without ncss. as a result, the voluntary and involuntary consumption of these additives is growing significantly in the population, increasing the risk of exceeding the acceptable daily intake (adi), especially for children. this situation is worrying as recent evidence suggests that ncss are not inert in the body and can trigger adverse metabolic effects. for example, the consumption of beverages with ncss has been shown to favor the development of obesity and type-2 diabetes in children and adults, and a recent study reported that the intake of ncss during pregnancy was associated with a greater weight gain of the child at one year. it is likely that certain ncss pass into the amniotic fluid and that the fetus is exposed to some of these compounds during pregnancy. this situation would persist in the infant through breast milk, as some studies detected sucralose and acesulfame-k in this fluid, even in mothers who claimed not to consume them. however, the real impact of ncs exposure during the neonatal period on the child health has been few studied. therefore, the aim of this study is to determine the concentration of ncss in samples of amniotic liquid and breastmilk and to correlate these data with the ncs intake by the mothers. mothers/children will be classified in quintiles according to the results obtained. in the children from quintiles 1 and 5, we will also study whether neonatal exposure to ncss may affect the sweet taste threshold and the preferences for this taste, the levels of salivary insulin and the weight gain in the first year. breastmilk microbiota and child fecal microbiota will be also evaluated.


Eligibility criteria:
inclusion criteria: * women with at least 36 weeks of gestation * spanish-speaking * elective cesarean delivery exclusion criteria: * multiple pregnancy * type-2 diabetes * intelectual disability * presence of infectious disease compatible with chorio-amnionitis or immunosupression * newborns with serious pathologies affecting their growth

Keywords: non-caloric sweetener amniotic liquid breastmilk infant gain weight sweet taste preferences taste receptor polymorphism breastmilk microbiota infant gut microbiota salivary insulin
obesity, peep and postoperative oxygenation

Conditions: Oxygenation

Summary: a study on overweight patients undergoing anesthesia for laparoscopic surgery. - evaluation of positive end-expiratory pressure versus zero positive end-expiratory pressure during awakening on oxygenation in the early postoperative period.

positive end-expiratory pressure (peep) is often used during mechanical ventilation to preserve end-expiratory lung volume. after emergence and extubation, this volume will diminish instantly. some patients will have difficulties to restore functional residual capacity (frc) during the early phase of recovery. if routine high fio2 is being delivered together with maintained peep prior to extubation, several important prerequisites are established for the development of postoperative atelectasis. the investigators hypothesize that establishing zero positive end-expiratory pressure (zeep) immediately prior to emergence preoxygenation, will prevent gas with high oxygen concentration from entering dorso-basal areas of the lungs, and thereby diminishing postoperative atelectasis formation and improve oxygenation. this randomized controlled study will study overweight patients undergoing general anesthesia for laparoscopic surgery. the patients in the two study groups will receive mechanical ventilation with identical settings, comprising low tv, peep, and no rm. randomization will occur at the end of surgery, before awakening. the patients will be allocated to zero peep (zeep) or maintained peep during emergence preoxygenation and extubation. importantly, the intervention group will have zeep established while still having low eto2 levels, prior to any preoxygenation. arterial blood gases will be collected before, during and after anaesthesia. primary endpoint measure will be change in oxygenation from before awakening to after awakening.

Eligibility criteria:
inclusion criteria: * obese patients scheduled for elective laparocopic surgery. * american society of anesthesiologists functional class i-iii * body mass index 35-50 kg/m2 exclusion criteria: * body mass index ≥50 kg/m2 * peripheral oxygen saturation (spo2) breathing air \<94 % * symtomatic asthma, copd or heart failure * ischemic heart disease * hemoglobin \< 100g/l * smokers and ex-smokers that stopped smoking \< 9 months ago * need for peroperative rm and peep higher than in study protocol, as indicated by spo2 \<92% despite the stipulated fio2 0.30-0.35. * obstructive sleep apnea syndrome on home-cpap

Keywords: oxygenation positive end-expiratory pressure general anaesthesia obesity atelectasis mechanical ventilation
is a smartphone application effective as an oral medication adherence aid

Conditions: Hypertension; Diabetes; Dyslipidemia

Summary: this research will act as a pilot study that will be conducted to determine the effectiveness of a smartphone medication adherence application on adherence to oral hypertensive, diabetic, and dyslipidemic medications using a prospective randomized design. subjects will be recruited from the university of arkansas for medical sciences (uams) internal medicine clinic north, and the study data will be collected using only subject self-reports and subject pharmacy records.


Eligibility criteria:
inclusion criteria: * males and females at least 18 years of age * provide informed consent * prescribed an oral medication indicated for hypertension, diabetes, or dyslipidemia during 12 weeks pre-enrollment * own a smartphone (android or ios) with unlimited text messaging, email access, and app store access * oral confirmation that the subject has not previously used a medication adherence app * able to consult with a pharmacy or medical student during the recruitment process for purposes of consent, data collection, and/or medication reconciliation, and/or mymedschedule registration exclusion criteria: * severely impaired vision * reside in a nursing home * non-ambulatory/bedridden * not fluent in english
observational study to assess sociodemographic and clinical features of patients treated with rivaroxaban in routine clinical practice of hematologists, cardiologists and internists of spain

Conditions: Atrial Fibrillation

Summary: depict demographic and clinical features of patients with atrial fibrillation treated with rivaroxaban to prevent stroke and pulmonary embolism in routine clinical practice


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * patients with atrial fibrillation * patients in treatment with rivaroxaban for stroke prevention in atrial fibrillation at least 3 months previous to inclusion period in study exclusion criteria: * patients in treatment after start of study * patients treated with other anticoagulant treatment

Keywords: stroke prevention on atrial fibrillation prevention and control stroke
innovations in clinical care of ce approved nucleus cochlear implant recipients

Conditions: Hearing Loss

Summary: this study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. the evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. each feature will be tested in a sub-study specific to that hearing care model. on average, each sub-study is expected to include approximately 20 subjects.


Eligibility criteria:
inclusion criteria: * users of a ce approved nucleus cochlear implant, resulting in open set speech understanding * at least three months of experience with the cochlear implant. * older than 18 years when entering the study. * subject is fluent speaker in the language used for assessments. * open set speech understanding sufficient to complete the study protocol as judged by the investigator. * willing and able to provide written informed consent exclusion criteria: * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations. * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees or employees of contract research organizations or contractors engaged by cochlear for the purposes of this investigation. * currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
accelerated dose schedule of cytarabine consolidation therapy for older patients with acute myeloid leukemia (aml) in complete remission

Conditions: Acute Myeloid Leukemia

Summary: this phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (hidac) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * both males and females ≥ 61 years of age * a clinical diagnosis of de novo, non-m3 acute myeloid leukemia (aml) confirmed by greater than 20% blasts in peripheral blood or on diagnostic bone marrow biopsy who have completed intensive induction chemotherapy and are confirmed in complete remission #1 (defined by \ 1000/ul and platelets \> 100x103/ul) and able to receive hidac consolidation #1 * patients on the prospective arm must be willing to have labs/clinic visits at uf health shands approximately every 48 hours +/- 24 hours after discharge from chemotherapy admission to be included. if prospective subjects cannot be followed at the uf site then telephone visits are allowed to follow for toxicity and transfusions. records can be requested from subject's local physician office. * written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures. for subjects on the historical arm, there will be a waiver of informed consent (as these patients may be deceased or not be available for retrospective consent). exclusion criteria: * age \< 61 years * patients unable to provide informed consent for prospective arm * secondary aml (documented history of antecedent hematological disorder, such as myelodysplastic syndrome or therapy-related aml) or chronic myeloid leukemia (cml) in blast crisis * patients receiving, received, or who will receive a flt3 inhibitor * patients receiving, received, or who will receive an idh1 or idh2 inhibitor * serum creatinine greater than 2 mg/dl * history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician * prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness * for historical arm, subjects will be excluded if adequate data is not available in electronic medical record (e.g., if patient was followed by their local oncologist between chemotherapy cycles and labs/transfusions/clinic notes, etc. are not available) * karnofsky performance status of 40 or less at study entry

Keywords: acute myeloid leukemia high dose cytarabine hidac consolidation chemotherapy schedule bone marrow elderly
telemonitored exercise to attenuate metabolic dysregulation in spinal cord injury

Conditions: Spinal Injuries

Summary: the purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.

the specific objectives are to assess the impact of 16 weeks of home-based telemonitored functional electrical stimulation leg cycle ergometry (feslce) exercise on body composition and metabolic health in adults with c4-t4 motor complete sci. this study is available only to those who were previously enrolled in the science protocol #20190659 that were randomized to the diet alone group. after completing the dietary intervention, those individuals will have an opportunity to experience fes bicycle.

Eligibility criteria:
inclusion criteria: * women of child-bearing potential who agree to refrain from getting pregnant during the trial * previously enrolled in the science protocol (nct03495986) randomized to the diet alone group in science, and are willing to complete an 8-week (2 month) washout period after the completion of the dietary intervention in the study. exclusion criteria: * do not meet inclusion criteria above * those who have participated in a functional electrical stimulation (fes) or ace exercise program (\>60 minutes/week) within the past 3 months * self-reported or documented history of: * orthopedic limitations * coronary artery disease * type 1 diabetes mellitus; insulin-requiring type 2 diabetes mellitus; untreated type 2 diabetes mellitus * untreated hypothyroidism * renal disease * uncontrolled autonomic dysreflexia, recent (within 3 months) * deep vein thrombosis (within the past 3 months) * on anticoagulation therapy * pressure injuries \> grade ii * decisional impairment * prisoners * pregnant or nursing women * any potential causes of autonomic dysreflexia at the discretion of the pi
everolimus in treating patients with locally advanced or metastatic thyroid cancer

Conditions: Head and Neck Cancer

Summary: rationale: everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.

objectives: primary * to evaluate response rate in patients with locally advanced or metastatic, unresectable or refractory thyroid cancer treated with everolimus. secondary * to evaluate overall survival of these patients treated with everolimus. * to evaluate progression-free survival of these patients. * to evaluate toxicity of this therapy in these patients. outline: this is a multicenter study. patients receive oral everolimus once daily on days 1-28. treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. blood samples are collected periodically for correlative studies. after completion of study treatment, patients are followed up for 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed thyroid cancer * progressive or refractory disease within the past 6 months * locally advanced or metastatic disease * measurable disease, defined as ≥ 1 measurable lesion defined by recist criteria * not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy * no untreated brain metastasis patient characteristics: * ecog performance status 0-2 * life expectancy \> 3 months * anc ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9.0 g/dl * creatinine \< 1.5 mg/dl * total bilirubin ≤ 1.0 times upper limit of normal (uln) * alt and ast ≤ 3.0 times uln * no known hypersensitivity to the study drug * no serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes) * no history of significant neurological or mental disorder, including seizures or dementia * no other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin * no active uncontrolled cardiac disease * no myocardial infarction within the past 12 months * able to take oral medication * no active peptic ulcer disease * must have patient compliance and geographic proximity for adequate follow-up prior concurrent therapy: * at least 30 days since prior mtor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy * at least 2 weeks since prior and no concurrent p-glycoprotein, cyp3a4, and cyp3a5 inhibitors or inducers * no prior surgical procedure affecting absorption * no other concurrent systemic chemotherapy, investigational drug, or radiotherapy

Keywords: anaplastic thyroid cancer insular thyroid cancer recurrent thyroid cancer stage iii follicular thyroid cancer stage iii papillary thyroid cancer stage iv follicular thyroid cancer stage iv papillary thyroid cancer thyroid gland medullary carcinoma
combining intratumoral metabolic heterogeneity and dissemination feature (dmax) on 18f-fdg pet/ct improves prognosis prediction in dlbcl

Conditions: Diffuse Large B-cell Lymphoma

Summary: this retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (mh), disseminate feature (dmax) and total metabolic tumor volume (tmtv) by 2-deoxy-2-\[18f\]fluoro-d-glucose positron emission tomography/computed tomography (\[18f\]fdg pet/ct), and establish novel nomograms to improve prognosis prediction in diffuse large b-cell lymphoma (dlbcl)

this retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (mh), disseminate feature (dmax) and total metabolic tumor volume (tmtv) by 2-deoxy-2-\[18f\]fluoro-d-glucose positron emission tomography/computed tomography (\[18f\]fdg pet/ct), and establish novel nomograms to improve prognosis prediction in diffuse large b-cell lymphoma (dlbcl) patients would be retrospectively includedin this study.the inclusion criteria included (1) pathologically proven dlbcl; (2) first-line treatment with r-chop or r-chop-like chemotherapy including r-minichop and r-echop (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin); (3) at least 2 evaluable hypermetabolic lesions on pet/ct;(4) underwent pre-treatment \[18f\]fdg pet/ct.

Eligibility criteria:
inclusion criteria: * (1) pathologically proven dlbcl, (2) first-line treatment with r-chop or r-chop-like chemotherapy including r-minichop and r-echop (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin),(3) at least 2 evaluable hypermetabolic lesions on pet/ct, (4) underwent pre-treatment \[18f\]fdg pet/ct exclusion criteria: * (1) patients who had received surgical resection or other treatments before chemotherapy, (2) patients who had coexistent central system lymphoma or other types of malignancies

Keywords: diffuse large b-cell lymphoma positron emission tomography (pet) metabolic heterogeneity dissemination metabolic tumor volume