Kornimate/medical-research-clean huggingface dataset:
modified cd19 car-t in patients with relapsed or refractory cd19+ b-cell malignancies

Conditions: Refractory B-Cell Non-Hodgkin Lymphoma; Refractory Leukemia

Summary: this study aims to evaluate the safety and tolerance of modified cd19 car t cells in treating refractory/relapsed b-cell malignancies. car-t cells will be investigated as a single agent both in relapsed/refractory b-cell acute lymphoblastic leukaemia (b-all) and up to 60% of patients with b-cell non-hodgkin's lymphoma (nhl).


Eligibility criteria:
inclusion criteria: 1. male or female aged 18-70 years; 2. estimated survival time ≥ 12 weeks; 3. histologically confirmed diagnosis of cd19+ b-all or cd19+ b-nhl(meeting one of the following conditions): 1. ineffectively or relapses after 2 or more remedial treatments 2. relapse after auto-hsct or unsuitable for auto-hsct; 4. at least one assessable tumor lesion; 5. ecog performance status 0 to 2; 6. creatinine clearance rate≥ 60 ml/min, alt and ast ≤ 2.5 times of upper limit of normal, total bilirubin ≤ 1.5 times of upper limit of normal; 7. male and female of reproductive potential must agree to use birth control during the study and for at least 30 days post study; 8. patients or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: 1. patients with other uncontrolled malignancies; 2. previously treated with any car-t cell product or other genetically-modified t cell therapy; 3. patients with hiv infection, hepatitis b (hbsag positive) or hepatitis c（anti-hcv positive); 4. patients with central nervous system involvement by lymphoma ,malignant cells in cerebrospinal fluid or history of brain metastasis; 5. patients with atrial or ventricular involvement by b-cell malignancies; 6. patients with tumor mass require urgent treatment, such as ileus or vascular compression; 7. patients with severe disease or other uncontrolled diseases that were not suitable for this trial, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, grade 2-3 hypertension; 8. unstable pulmonary embolism, deep venous embolism, or other major arterial/venous thromboembolism events occurred within 30 days prior to randomization. if patients receive anticoagulant therapy, the treatment dose must be stable prior to randomization; 9. any situations that the investigators believes were not suitable for this trial; 10. long-term use of immunosuppressive agents after organ transplantation, except for the patients recently or currently receiving inhaled steroids; 11. pregnant(or lactation) women; 12. patients with severe active infections(excluding simple urinary tract infection and bacterial pharyngitis)within 30 days prior to randomization

Keywords: modified cd19 car-t
social influences on adolescents' snack purchases

Conditions: Social Influences; Food Consumption

Summary: the purpose of this study is to assess the effects of peer influences on snack purchases in adolescents. during the session teens will be given a certain amount of money to use to purchase foods and beverages in a hypothetical convenience store setting. the investigators hypothesize that overweight youth will be less responsive to own-price elasticity for high calorie foods and less likely to show cross price elasticity for low calorie foods when the price of the high calorie for nutrient foods increases. the investigators also predict that overweight youth will show more cross price elasticity for low calorie foods when in the presence of peers; whereas lean youth's food purchases and price sensitivity will not be affected by the presence of peers.


Eligibility criteria:
inclusion criteria: * boys and girls ages 12-14 * youth must have at least a moderate liking of study foods used * youth must be at or above the 15th bmi percentile exclusion criteria: * youth should have no dietary restrictions * youth should have no food allergies * youth should have no medical conditions that alter the body's ability to absorb nutrients or that can otherwise influence the participants' response to food

Keywords: social influences food purchases childhood obesity amount of energy dense food and beverage items purchased amount of nutrient dense food and beverage items purchased
the role of rapid diagnostic tests for malaria for targeting of acts at community level

Conditions: Malaria

Summary: this study aims to test directly by means of a cluster randomized controlled trial, the impact of the introduction of rdts for malaria on dispensing behaviour of chemical sellers, the main non-formal outlet for drugs locally, at community level.

in many settings the majority of people with malaria particularly the poorest do not access formal care but access anti-malarials at the informal community level. acts were previously unaffordable to this group but this should change with the introduction of the amfm. to avoid missing alternative causes of illness, reduce costs and delay the spread of resistance to acts, they need to be targeted at those who really need them. studies in formal healthcare settings in ghana have shown that where microscopy is not available, the impact of rapid diagnostic tests (rdts) can be substantial. rdts are relatively simple to use, requiring fairly minimal training to master the mechanics of test preparation and interpretation whether to deploy rdts as part of amfm is unclear at this time.even in the absence of amfm the question about how best to target antimalarials in the community is an important one, and will get more so as malaria incidence in many countries decreases, making presumptive treatment of all febrile illness as malaria increasingly ineffective. locally chemical sellers are the closest equivalent as they provide the majority of treatments, especially for the poorest. it is difficult to predict whether rdts would make chemical sellers more commonly accessed (because patients prefer a diagnosis) , or less accessed (patients do not like having choice restricted/do not want a blood test etc). studies in other settings suggest interventions to improve diagnosis by shop-keepers can be effective and cost-effective .

Eligibility criteria:
inclusion criteria: * patients reporting to chemical seller with complaint of fever or who request for an anti-malarial drug exclusion criteria: * clients providing a prescription from a health facility * clients with signs of severe disease who will be referred onward

Keywords: malaria rapid diagnostic tests for malaria chemical shops drug shops diagnostics testing for malaria
mitochondrial dna as a biomarker of sepsis severity

Conditions: Sepsis Syndrome; Sepsis; Severe Sepsis; Septic Shock; Infection

Summary: mitochondria are organelles (a specialized subunit of a cell) responsible for providing cells with energy. for reasons not yet understood, mitochondria will release their dna into blood in response to cellular injury or cell death. with a simple blood draw, investigators can measure the amount of mitochondrial dna in a patient's blood. the investigators' hypothesis, is that mitochondrial dna can be used as a surrogate marker of cellular injury to predict patient outcomes. the investigators intend to test their hypothesis by measuring mitochondrial dna in adult patients presenting to the emergency department with sepsis (a life-threatening condition due to an infection) and observing their hospital course.

despite the advances of modern medicine, sepsis persists as one of the leading causes of death in the united states and poses a significant burden on u.s. health care, accounting for more than $24 billion of total hospital costs in 2013. the high mortality and cost of treating sepsis at least partially stems from the consequences of delayed diagnosis. unfortunately, this delay is attributable to the broad clinical manifestations of the syndrome and the absence of a specific test for sepsis. realizing this, the society of critical care medicine and the european society of intensive care medicine have released guidelines emphasizing the need for diagnostic approaches aimed at the early detection of sepsis. the hope is that early recognition will allow for more aggressive upfront management thereby improving patient outcomes. in 2013, nakahira et al showed that circulating cell-free mitochondrial dna levels are associated with sepsis and mortality in patients admitted to the icu. in contrast to that study, the purpose here is to determine whether circulating cell-free mitochondrial dna and other biomarkers are associated with the severity of sepsis and 28-day mortality in patients presenting to the ed with sepsis. to accomplish this task, the investigators intend to prospectively collect specimens from patients presenting to nyp-weill cornell and nyp-brooklyn methodist with suspected sepsis.

Eligibility criteria:
inclusion criteria: * adults presenting to the emergency department with suspected sepsis. exclusion criteria: * pregnancy. * patients with limitations of care at the time of specimen collection.

Keywords: mitochondrial dna lactate mortality emergency department intensive care unit triage organ dysfunction biomarker prognosis
lithium in multiple system atrophy

Conditions: Multiple System Atrophy

Summary: the purpose of this study is to determine safety and tolerability of the treatment with lithium in multiple system atrophy. moreover, clinical symptoms, neuronal loss, quality of life and depressive symptoms, will be considered to further investigate the effect of lithium therapy.

patients will be progressively enrolled in the study and undergo a screening visit to test for inclusion/exclusion criteria. patients will then be randomized to receive either lithium carbonate or placebo. patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks, for endpoint and laboratory assessments.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable msa (gilman, et al. 2008) * age ≥18, \<80 exclusion criteria: * heart failure * liver disease * kidney failure * thyroid disease * sick sinus syndrome and/or significant ecg alterations * hyposodemia * treatment with diuretics * treatment with haloperidol and/or other antipsychotics * treatment with nsaids or corticosteroids * treatment with ace inhibitors * treatment with aminophyllines * treatment with mannitol * pregnancy and/or breastfeeding * acute diseases that might interfere with the trial

Keywords: msa lithium lithium carbonate msa-p msa-c
a study to evaluate the safety, tolerability, and immunogenicity of two lots of v114 in healthy infants (v114-008)

Conditions: Pneumococcal Infections

Summary: this study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of v114 in healthy infants 6 to 12 weeks (\>=42 days to \ =0.35 mcg/ml for each of pneumococcal serotypes 1, 3, 4, 5, 6a, 6b, 7f, 9v, 14, 18c, 19a, 19f, and 23f at 1 month after dose 3 is non-inferior to that for recipients of prevnar 13™.


Eligibility criteria:
inclusion criteria: * infant approximately 2 months of age (42 days to 90 days), inclusive * in good health exclusion criteria: * prior administration of any pneumococcal vaccine * known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine * known or suspected impairment of immunological function * history of congenital or acquired immunodeficiency (eg, splenomegaly) * mother has documented human immunodeficiency virus (hiv) infection * mother has documented hepatitis b surface antigen-positive test result * known or history of functional or anatomic asplenia * history of failure to thrive * history of a coagulation disorder * history of autoimmune disease * known neurologic or cognitive behavioral disorder * expects to require systemic corticosteroids within 30 days after each vaccination during the trial * prior administration of a blood transfusion or blood products, including immunoglobulin * participated in another clinical trial of an investigational product * history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
lenalidomide observational study in patients with mantle lymphoma in relapse/refraction. spanish programme rrmcl results.

Conditions: Mantle Cell Lymphoma

Summary: this is a multicentric, observational and retrospective study of the use of lenalidomide in patients with relapsed or refractory mantle cell lymphoma that are included in the rrmcl spanish program. the lenalidomide effectiveness and tolerability data will be retrospectely collected until the 30 of april 2018.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old. * diagnosed with relapsed or refractory mantle cell lymphoma verified by a tissue biopsy. * treated with monotherapy or combination of lenalidomide. * not candidate for any of the therapeutic options approved until that date for this disease. * not candidate or unable to be included in any clinical trial due to availability or geographical difficulty. * registered in the rrmcl spanish program. exclusion criteria: * ecog \> 2. * patients with uncontrolled comorbidities. * blastoid variant. * central nervous system tumor infiltration. * hiv, hbv and/or hcv active infection. * radiotherapy concomitant treatment or that have received radiotherapy in the previous 30 days to the beginning of the first cycle of lenalidomide. * diagnosed with other active solid tumor except for basal cell carcinoma skin cancer. * patients that haven´t completed at least one complete cycle of the treatment.

Keywords: lenalidomide mantle cell lymphoma relapsed refractory rrmcl spanish program
the potency of prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension

Conditions: Adverse Effect

Summary: the purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.

preeclampsia, which affects 5% to 7% of patients, is a significant cause of maternal and neonatal morbidity and mortality. because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in patients with preeclampsia are apparently higher than healthy patients, placental hypoperfusion is more common. spinal anesthesia is still the preferred mode of anesthesia in patients with preeclampsia for cesarean section. in preeclampsia patients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. even so, 17-26% patients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. as a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in patients undergoing cesarean section. however, the ed50 (prevent postspinal hypotension in 50% of patients) and ed90 of prophylactic norepinephrine bolus is still unknown. the purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients with severe preeclampsia during caesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification ii to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥180 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly

Keywords: norepinephrine phenylephrine postspinal anesthesia hypotension preeclampsia cesarean section
the undernourished patient: prevention and treatment

Conditions: Weight Loss

Summary: the purpose of this study is to determine whether a nutrition intervention during a rehabilitation stay followed by nutritional advice after discharge, can improve the nutritional status of the patients after 3 months.


Eligibility criteria:
inclusion criteria: 1. in risk of undernutrition or undernourished according to the screening tool nrs-2002, score 3 or above. 2. living in oslo, bærum or asker municipality. 3. must be able to cooperate. exclusion criteria: 1. unwilling to participate 2. less than 12 months life expectancy
quality-of-life-and-cognitive-oriented rehabilitation through the neuronup in alzheimer's disease

Conditions: Alzheimer Disease; Occupational Therapy; Quality of Life; Cognitive Impairment; Older People

Summary: introduction: new technologies are a support in the rehabilitation of users. the therapeutic approach to cognitive rehabilitation encompasses a variety of techniques, among which traditional occupational therapy stands out. this modality includes a series of interventions such as cognitive stimulation through the use of cards, functional activities, psychomotor exercises, the application of sensory stimuli and the incorporation of music therapy. an additional alternative is to integrate a cognitive stimulation program such as neuronup, which is a computerized tool. this integration can increase adherence to treatment and contribute to preserving or improving the individual's cognitive functioning and improving quality of life. objective: the objective established for this study was to verify whether the combination of occupational therapy with the neuronup computer program improves or maintains the cognitive status and quality of life of users with alzheimer's disease. in addition, to determine whether the use of this program leads to greater adherence to treatment by patients. material and methods: this is a randomized clinical trial. participants' cognitive status will be assessed using the mec (mini cognitive examination) tool, cognitive skills using the lotca (loewenstein occupational therapy cognitive assessment), and perceived quality of life using the whoqol-bref questionnaire. at the end of treatment, the csq-8, a tool designed to determine the degree of user satisfaction, will be administered.


Eligibility criteria:
inclusion criteria: * adult men or women, aged 65 years or olde. * not present severe cognitive impairment, measured through the mini cognitive examination test (mec\>22 points). * to reside permanently in the nursing home. * attend occupational therapy sessions regularly. * have adequate manual dexterity to be able to use a tablet. * agree to participate voluntarily in the study. exclusion criteria: * having severe cognitive impairment, as measured by the mini cognitive examination (mec\<22 points). * having comorbid diagnoses such as stroke, brain tumours or heart disease, among others. * not attending occupational therapy sessions regularly. * poor adherence to the treatments offered at the centre. * not agreeing to participate voluntarily in the study.

Keywords: alzheimer's disease occupational therapy neuronup quality of life cognitive stimulation cognitive impairment
pancreatic cancer and diabetes mellitus

Conditions: Pancreatic Cancer; Surgery; Diabetes Mellitus

Summary: the goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.the main questions it aims to answer are: 1. are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same? 2. are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? all patients with pancreatic surgery have been given the standardized treatment for the condition. the reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.

investigators will prospectively collect data from patients with pancreatic cancer after surgery in participant centers.

Eligibility criteria:
inclusion criteria: 1. male or female chinese subjects; 2. age ≥ 18 years; 3. patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital; 4. those who voluntarily completed the pancreatobiliary surgery cohort study and signed the informed consent; 5. those who have completed and banked serum and pathological specimens at our hospital. - exclusion criteria: 1. those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative hba1c ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol/l; 2. those with positive islet-associated antibodies 3. those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes; 4. pregnant or nursing women; 5. cognitive impairment or other reasons for failing to sign the informed consent form. -

Keywords: pancreatic cancer surgery diabetes mellitus risk factor
tracking cf lung disease through the early years: utility of the lci

Conditions: Observational

Summary: this is a prospective observational study to follow a cohort of patients with cystic fibrosis and healthy controls for a period of two years. this study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their respiratory symptoms every three months as well as during a pulmonary exacerbation and after their recovery.

this is a prospective observational cohort study. during the 3 year study period, each participant will be followed for a period of 2 years. the study will include quarterly measurements of the lung clearance index (lci), as well as spirometry, for cf patients at their routine clinic visits. parents of patients with cf will be asked to call the study nurse or clinical nurse if they experience a worsening of pulmonary symptoms and to come to the clinic for assessment of lung function. cf patients will then be assessed by a cf physician to assess whether they require antibiotic treatment based on a clinicians decisions to treat with antibiotics. the treatment decision will be left to the discretion of the patient's responsible physician, who will be blinded to the mbw results. all patients who meet the symptom based definition of a pulmonary exacerbation, regardless of treatment decision, will have mbw measured after 4 weeks. following these visits at the time of an exacerbation, patients will have their mbw measured at their next clinic visit (usually within 3 months), and every 3 months thereafter until the end of the 2 year observation period, or the repeat onset of symptoms.this study will capture a maximum of two exacerbations per patient over the 2 year study period.

Eligibility criteria:
inclusion criteria for healthy controls: * informed consent by patient or parent/legal guardian, verbal assent where appropriate * age 3 years to 16 years old * clinically stable with no signs of an acute exacerbation at enrollment visit * previously participated in a longitudinal mbw study at the hospital for sick children and at the riley hospital for children inclusion criteria for cf patients: * diagnosis of cf as defined by two or more clinical features of cf and a documented sweat chloride \> 60 meq/l by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations * informed consent by patient or parent/legal guardian, verbal assent where appropriate * age 3 years to 16 years old * clinically stable with no signs of an acute exacerbation at enrollment visit exclusion criteria: * previous organ transplantation * chronic lung disease not related to cf, such as asthma * use of intravenous antibiotics or other course of oral antibiotics (excluding maintenance treatment antibiotics) within 14 days of enrollment visit * physical findings at screening that would compromise the safety of the participant or the quality of the study data