Kornimate/medical-research-clean huggingface dataset:
cord blood derived car-t cells in refractory/relapsed b cell malignancies

Conditions: Refractory; Relapsed; B Cell Lymphoma; B Cell Leukemia

Summary: evaluation the safety and efficacy of cord blood-derived car-t cells in patients with relapsed/refractory b cell leukemia/lymphoma whose disease relapsed after autologous car-t cells therapy or who fail to preparation for autologous car-t cells

car-t cells therapy is the preferred option for relapsed/refractory b cell leukemia/lymphoma. however, some patients will relapse after car-t cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous car-t cells. the exploration of alternative source of lymphocytes for car-t cells preparation has important clinical implications for such patients. we evaluated the efficacy and safety of cord blood-derived car-t cells in such patients, and to explore effective treatment options for such patients.

Eligibility criteria:
inclusion criteria: * expected lifespan \>3 months * patients with refractory/relapsed b cell leukemia/lymphoma whose diseases relapse after autologous car-t cells or the preparation for autologous car-t cells fails * kps \>70 * for patients with lymphoma, at least one measurable lesion according to recist 1.1 * enough function of heart, liver, kidney and bone marrow * no history of severy allergy * no other serious diseases that conflict with this plan * no other history of malignancy * no serious mental illness * patients and their families members agree to participate in this clinical study and sign the informed consent form exclusion criteria: * pregnant or lactating women * vevere infectious or viral diseases * active hepatitis b or c viral hepatitis * patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks * participated in other clinical studies in the past 3 months or who have been treated with other gene products; * others that other investigators consider not suitable for this clinical study
regional cortical cerebral quantitative mri perfusion correlation neurocognition in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a common disease affecting 1/1000 canadians. cognition impairment is reported in 40-65% of patients and is socially and functionally disabling. although multiple sclerosis is widely regarded as a white matter disease, cortical disease burden is increasingly emphasized. studies confirm that gray matter (gm) disease is grossly underestimated by conventional mri. although the cause for ms is unknown vascular impairment is implicated in nerve cell death. several studies have shown perfusion abnormalities in the central gm and white matter (wm) structure. severity of perfusion reduction correlates with lesion load, atrophy, ms subtype and disease duration. further extent of cortical atrophy correlates with neurocognitive impairment. we hypothesize that cortical perfusion is a marker of cortical disease severity and correlates with neurocognitive impairment. to show this we will measure regional cortical perfusion and regional brain and wm lesion volumes in 26 predefined brain regions using a template developed for alzheimer's disease. regional perfusion will be correlated with neurocognitive tests validated for ms use. patients will be divided into impaired and non impaired and perfusion compared controlling for known confounding factors. if confirmed cortical perfusion may be utilized as a surrogate marker of cognitive outcome in therapeutic studies.

we hypothesize that cortical perfusion is a marker of cortical disease severity and correlates with neurocognitive impairment. to show this we will measure regional cortical perfusion and regional brain and wm lesion volumes in 26 predefined brain regions using a template developed for alzheimer's disease. regional perfusion will be correlated with neurocognitive tests validated for ms use. patients will be divided into impaired and non impaired and perfusion compared controlling for known confounding factors. if confirmed cortical perfusion may be utilized as a surrogate marker of cognitive outcome in therapeutic studies.

Eligibility criteria:
inclusion criteria: * established spms according to the mcdonald criteria exclusion criteria: * patients with a history of drug/alcohol abuse, a premorbid (pre ms) psychiatric history, a head injury with loss of consciousness and a concurrent physical disease requiring medical attention (eg. cardiovascular disease etc), mri contraindication including implants, pacemaker, aneurysm clips and known renal impairment

Keywords: cerebral blood flow
characterization of myocardial blood flow during heat exposure

Conditions: Hot Weather; Adverse Effect; Healthy; Coronary Artery Disease; Aging

Summary: the purpose of this study is to determine the increase in myocardial blood flow during heat exposure and how this response is affected by age and coronary artery disease.

as a result of climate change, heat waves are more frequent and of longer duration. these heat waves are associated with a higher risk of hospitalization and mortality in vulnerable populations such as people with cardiovascular disease or cardiovascular risk factors. it has been hypothesized that this observation may be explained by the cardiovascular demands imposed by heat exposure. heat exposure requires increased cardiac work that may place individuals with cardiovascular disease at risk of ischemic events if the metabolic demand is not compensated by adequate blood supply. however, the extent to which cardiac work increases during heat exposure remains unknown. the aim of this study is to test the hypothesis that heat exposure increases myocardial blood flow and that this increase is affected by age and coronary artery disease.

Eligibility criteria:
inclusion criteria for healthy participants: * age between 18-40 years or 60-80 years * non-smoker (≥1 year) * non-diabetic * normal kidney function * body mass index \<30 kg/m2 * resting blood pressure \<140/\<90 mmhg * resting heart rate \<100 bpm inclusion criteria for participants with coronary artery disease: * age between 60-80 years old * history of angiographic coronary disease (≥70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or perfusion defect during stress testing * stable medications (≥4 weeks) prior to enrollment exclusion criteria for healthy participants: * diagnosis of heart, vascular, respiratory, neurological or metabolic disease and/or a prescription of medication for the treatment of these diseases * pregnancy or lactation * dyslipidemia not controlled by medication exclusion criteria for participants with coronary artery disease: * recent hospitalization (\<3 months) related to coronary artery disease * unstable angina (\<3 months) * recent coronary artery bypass surgery (\<3 months) * left branch block * ejection fraction \<40% and/or clinical signs of heart failure * severe valvular heart disease * hypertension not controlled by medication * diabetes not controlled by medication and/or serious complications related to diabetes

Keywords: heat pet imaging myocardial blood flow
clinical relevance of ros (v-ros ur2 sarcoma virus oncogene homolog) aberrations in solid tumours

Conditions: Cancer

Summary: alterations involving the ros (v-ros ur2 sarcoma virus oncogene homolog 1) gene such as mutations, overexpression and gene rearrangements has been implicated in carcinogenesis and has been demonstrated to be a relevant target for alk inhibitors. while emerging reports have demonstrated the role of ros rearrangement in non-small cell lung cancer and cholangiocarcinoma, the functional significance of ros dysregulation in solid tumors remain largely unstudied. the investigators aims are: (1) to characterize the frequency of ros gene fusion, ros protein overexpression and ros gene mutations in cell lines and tumors from patients with hepatocellular carcinoma, colorectal, gastric, breast, ovarian, cholangiocarcinoma and non-small cell lung cancer, (2) to identify novel ros gene variants in human solid tumors harboring ros aberrations using next generation sequencing (ngs), (3) to determine the functional relevance of novel ros gene variants identified with ngs, (4) to characterize the sensitivity of cells with functionally relevant ros aberrations using ros tyrosine kinase inhibitors. ros fusions and protein overexpression will be screened in a panel of cell lines and primary tumors using fluorescence in-situ hybridization and immunohistochemistry respectively. targeted next-generation sequencing will be applied to identify ros variants in matching cancer types demonstrating high levels of gene fusion and protein overexpression. functional characterization of novel ros variants will be performed by silencing (shrna) and overexpressing candidate cell lines with the respective ros mutations/fusions, and evaluating their effects on biological functions including cell proliferation, migration, invasion and apoptosis, as well as sensitivity against ros/alk inhibitors. the investigators anticipate findings from this study will improve the investigators understanding of aberrant ros signaling in an expanded group of cancer types, and potentially identifying a larger group of cancer patients that will benefit from ros targeted therapy. further insight of the role of ros receptor tyrosine kinase will confirm it as a therapeutic target in human solid tumors and hence expand the indication of crizotinib and other dual alk/ ros inhibitors. furthermore, given the rarity of ros fusion receptor tyrosine kinase in reported cancers, defining the epidemiology of ros aberrations in other unreported cancers harboring ros pathway activation is essential to properly design future clinical trials of ros inhibitors. the validation of ros receptor tyrosine kinase will also provide a new therapeutic target in the treatment of cancer and expand the role of novel targeted agents. findings from this study will further the investigators knowledge on the oncogenic functions of the ros and the application of ros inhibitors in an extended group of solid tumors.


Eligibility criteria:
inclusion criteria: - patients with cancer
a study comparing mindfulness apps to decrease anxiety in people with lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to find out if it is practical to provide the program contained within the smartphone app amdtx before and after lung cancer surgery. amdtx is a platform that re-configures according to the specific needs of patients through physician prescriptions.


Eligibility criteria:
inclusion criteria: * histologically proven lung cancer * patients with suspected primary lung cancer per recent chest ct scan (with or without contrast) may be enrolled in the trial. these patients may be randomized and begin study intervention without a biopsy. if a patient undergoes a biopsy after consent and the results are negative or if the patient does not proceed with surgery, the patient will be removed from the study. the patient will continue to receive full access to the amdtx app for 2-years. * scheduled for surgery with at least 14 days lead time (to allow the participant to start the mindfulness practice \[intervention group\] 14 days preoperatively) * age ≥18 years of age at time of signing informed consent * access to a smartphone/tablet with data connection * willing to give time for mindfulness practice (patients need to have the motivation to devote approximately 20 to 30 min daily, which is equal to 5 to 7 sessions a week over the course of a minimum of 6 weeks to do the mindfulness meditations and practices) * willing to be randomized to mindfulness mbcr or ci group and complete all assessments * high distress level (distress thermometer score ≥4 at initial visit) * able to understand the study objectives and procedures, comply with the protocol, and sign an informed consent * able to read, speak, and understand english exclusion criteria: * currently engaging in app-based mindfulness or meditation for one or more times per week * as per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). patients diagnosed with a major psychiatric disorder will be reviewed by the study pi to determine eligibility before consent * individuals with impaired decision-making capacity * patients that need to undergo neoadjuvant therapy (chemotherapy±radiation) * patients undergoing active treatment of other non-lung cancers * patients with recurrent lung cancer

Keywords: anxiety mindfulness apps 23-114
impact of idpn on nutrition markers in patients receiving ichd

Conditions: End-stage Renal Disease; Malnutrition; Protein

Summary: evaluate the impact of intradialytic parenteral nutrition (idpn) compounded with clinisol, prosol, and/or clinolipid on albumin levels and weight in patients with end-stage renal disease (esrd) undergoing in-center hemodialysis. determine the average duration of time it takes for albumin levels to rise ≥0.2g/dl from the initiation of idpn therapy as this has been associated with significant change in mortality and hospitalization risk. the investigators expect levels to rise significantly within 4-6 months, there may be a difference in outcome in patients receiving idpn compounded with amino acids and dextrose only vs idpn compounded with amino acids, lipid, and dextrose.

intradialytic parenteral nutrition (idpn) has been identified as a means of improving nutrition status in malnourished hemodialysis patients who cannot meet calorie and protein needs with oral intake alone. the retrospective chart review spanning 3 years will be conducted on in-center hemodialysis patients receiving idpn concurrent with their dialysis treatment. this study will evaluate the impact of intradialytic parenteral nutrition (idpn) compounded with clinisol, prosol, plenamine, intralipid and/or clinolipid on albumin levels in patients with end-stage renal disease (esrd) undergoing in-center hemodialysis and determine if addition of clinolipid changes response to idpn therapy compared to idpn without lipids or idpn with intralipid. the primary endpoint is change in albumin levels from baseline (average albumin of up to 3 months prior to initiation of idpn therapy) to 6 months after idpn therapy initiation for the full analysis set. secondary endpoints will be analyzed and include: distinguishing factors between those that respond to idpn therapy (0.2g/dl or more increase in albumin levels) and those that do not; assessing time to idpn response (increase of 0.2g/dl in albumin levels); determining factors that predict idpn response; and comparing amount of change in albumin levels, percent of patients responding to idpn therapy, and amount of time to idpn response between those that receive lipids with idpn therapy and those that do not receive lipids.

Eligibility criteria:
inclusion criteria: * receiving in-center hemodialysis 3 days per week * having any diagnosis of esrd * icd-10 code n18.6 * idpn therapy initiated between may 1, 2018 and april 30, 2021 (evaluating through october 31, 2021) * baseline data available, average of up to 3 months of albumin levels available prior to start of therapy * age 18 years or older at idpn therapy initiation * consented to have their medical records used for research exclusion criteria: * - dialysis prescription deviates from the standard 3 days per week * idpn or intraperitoneal nutrition (ipn) therapy was initiated outside the research window * under 18 years of age at idpn initiation * history of liver disease or gastric bypass * undergoing cancer treatment at any time during idpn therapy * receiving enteral nutrition support or total parenteral nutrition
ccrt followed by tegafur, gimeracil and oteracil potassium in cervical cancer

Conditions: Cervical Cancer; Chemotherapy

Summary: this is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (ccrt) followed by tegafur, gimeracil and oteracil potassium capsules consolidation chemotherapy in patients with locally advanced cervical cancer.

this is a single institute, single-arm, interventional trial to evaluate the efficacy and toxicity of concurrent chemoradiotherapy (ccrt) followed by tegafur, gimeracil and oteracil potassium capsules consolidation chemotherapy in patients with locally advanced cervical cancer. the main inclusive criteria are as follows: histology confirmed cervical cancer; 18-70 years old; 2018 international federation of gynecology and obstetrics (figo) stage iib-iiic2; ecog score \<=1 point. the estimated enrollment is 200 patients. after enrollment, patients will receive ccrt, including external beam radiotherapy, intracavitary brachytherapy and concurrent chemotherapy. one month after the completion of ccrt, patients will receive 6 cycles of tegafur, gimeracil and oteracil potassium capsules consolidation chemotherapy. the primary endpoint is progression free survival. and the secondary endpoints include overall survival, distant metastasis-free survival, local regional recurrence-free survival, acute toxicities, late toxicities, and treatment compliance.

Eligibility criteria:
inclusion criteria: histology confirmed cervical cancer; 18-70 years old; 2018 international federation of gynecology and obstetrics (figo) stage iib-iiic2; eastern cooperative oncology group (ecog) score \<=1 point.; adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/l, hemoglobin ≥ 80 g/l, platelet count ≥100\*10\^9/l; normal liver and kidney function: creatinine (cr) \< 1.5 mg/dl, alanine aminotransferase (alt), aspartate aminotransferase (ast) \< 2\*upper limit of normal (uln). exclusion criteria: prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes; prior malignancy;history of previous radiotherapy to the abdomen or pelvis; pregnancy or lactation; active infection with fever; ssevere disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
the banana exercise type 1 diabetes study

Conditions: Type 1 Diabetes

Summary: former and current kadet athletes participate in two controlled training sessions: one with a banana 20 minutes pre-exercise and one without. tandem data recorded includes sensor glucose, training details, insulin dosing, and meal intake. continuous glucose monitoring (cgm) data is assessed. endpoints include differences in glucose levels, hypoglycemia events (sg \<3.9 mmol/l), and time in range during training

participants: former and current kadet athletes invited via a facebook group. previous participants in study projects who have expressed interest in being contacted for future studies. protocol: participants provide written consent for data collection and use. each participant completes two training sessions under controlled conditions, including: same training time standardized pre-training meal timing and insulin corrections similar intensity and environmental factors if pre-training hypoglycemia occurs, training is rescheduled or corrected with glucose tablets, which are documented. study conditions: session 1: participant eats a banana 20 minutes before training. session 2: no pre-training food intake. tandem control iq users (insulin pump) take a microbolus (0.05 ie) before banana intake. recorded data by participant: training start and end times sensor glucose (sg) at start and end of training training type and intensity (borg scale, heart rate monitoring) last insulin dose (meal and correction) last meal details (content and timing) banana documentation (photo, weight with peel, ripeness level) cgm data are also assessed. endpoints: differences in gcg glucose level time to hypoglycemia and number of hypoglycemia events (sg \<3.9 mmol/l) on banana vs. non-banana days. percentage of time in range during training. additional data is reported as available.

Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * cardiovascular comorbidity * neuropathy

Keywords: nutrition cgm blood glucose exercise
covid-19 and geko evaluation: the cage study

Conditions: Covid19

Summary: the primary objectives of this pilot study protocol are to assess safety and feasibility of using the geko™ device in covid-19. regarding safety to patients, we will measure the rate of adverse events, primarily local site irritation or discomfort. feasibility will be measured on the basis of recruitment; ability to enroll sufficient number of patients meeting criteria. protocol adherence will be observed as the ability to deliver the study intervention to the patients randomized to the treatment arm within the prescribed timeline and ability to complete the course of treatment. additionally, we plan to measure patient outcomes such as icu admission and death. the findings of this study have the potential to decrease the complications seen in covid-19 infections.

on march 11, 2020, a global pandemic was declared by the world health organization. a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (sars-cov-2) was identified as the cause of the covid-19 pandemic. sars-cov-2 infection has quickly become one of the fastest growing and deadliest diseases to surface due to its high death rate and ability to replicate and spread readily from people without symptoms. recent evidence indicates that critically ill patients with covid-19 experience a high risk of blood clots. deep leg vein blood clots can travel to the lungs and cause severe lung failure and death. the geko™ device is a simple device that increases the return of blood flow from the lower legs and potentially decrease the risk of lung blood clots. investigators believe the geko™ device may have an important benefit in covid-19 patients by decreasing the risk of lung clots and decrease the risk of respiratory failure which is often the cause of death in covid-19 patients. in this study, investigators plan to study the effect of using the geko™ device in covid-19 patients and measure patient outcomes such as icu admission and death. the findings of this study have the potential to decrease the complications seen in covid-19 infections.

Eligibility criteria:
inclusion criteria: * patients who test positive for covid-19 exclusion criteria: * patients who are unlikely to be adherent or cannot tolerate the therapy (self-report) * prior above or below knee amputation * a history of prior deep venous thrombosis (dvt) or venous thromboembolism (vte), * those patients being treated with full dose therapeutic anticoagulation. * patients with pacemakers

Keywords: icu covid 19 c19 coronavirus geko deep venous thrombosis dvt
mass balance and metabolic profiling of [14c]azd5672 in healthy male volunteers

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine how the body breaks down and excretes the investigational drug, azd5672.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) 18-30 kg/m2, inclusive. * clinically normal findings in physical examination, ecg, vital signs, clinical chemistry, haematology \& urinalysis, as judged by the investigator exclusion criteria: * healthy volunteers who have been exposed to radiation levels above background (eg through x-ray examination) of \>5 msv in the last year, \>10 msv over the last 5 years or a cumulative total of \>1 msv per year of life * clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator * use of prescribed medication (including st. john's wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Keywords: pharmacokinetics mass balance radiolabel azd5672