Kornimate/medical-research-clean huggingface dataset:
the systemic lupus erythematosus (sle) activity gene expression (sage) study

Conditions: Systemic Lupus Erythematosus

Summary: the goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity. ultimately such a newly derived test would allow treating physicians to start pre-emptive therapy early, with the goal of achieving remission quickly and with a shorter duration of treatment; identify individuals who will have less severe flares and will thus require less aggressive treatments; or intensify and lengthen treatment for those individuals who will need such therapy. the design of this study is to follow individuals with a known diagnosis of sle for changes in disease activity during the course of one year of observation. clinical data and blood and urine samples will be collected at scheduled monthly visits. the clinical data and blood samples will be used for identifying gene expression profile(s) that are associated with increases in sle disease activity (lupus "flares").

this study is currently enrolling individuals who have an established diagnosis of sle to participate. there is no cost to volunteers who participate and the study pays for the visits to the clinics for monthly collection of clinical information and blood and urine samples. women who are or become pregnant may participate in the study with the recommendation of their health care providers and the study doctors.

Eligibility criteria:
inclusion criteria: * individual has met the diagnostic criteria for sle (at least 4 out of the 11) american college of rheumatology (acr) criteria and: * has experienced specific manifestations of lupus disease activity within the last 12 months including the following: * lupus nephritis (kidney disease); vasculitis and or central nervous system involvement and/or: * required treatment with at least 20 mg per day of prednisone (or equivalent) and/or: * required hospitalization directly due to sle disease exclusion criteria: * subjects unable or unlikely to cooperate with the procedures of the protocol * substance abuse / dependence that in the opinion of the investigator could compromise the subject's ability to complete the study * subject with a more dominant autoimmune disease, e.g. rheumatoid arthritis, sjogren's syndrome, multiple sclerosis, scleroderma * history of malignancy within the last five years with the exception of basal cell carcinoma * active infection: known hiv positive status, currently active tuberculosis , active infection receiving antibiotics * had tissue or organ transplantation (including bone marrow) * on chronic hemo- or peritoneal dialysis

Keywords: autoimmune diseases lupus
nitrite-boosting therapy for improving physiological function in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: nitric oxide (no) is an essential molecule in the body that is decreased in patients with chronic kidney disease (ckd), leading to reductions in vascular, movement ("motor") and cognitive functions. this study will determine if daily oral supplementation (3 months) with a supplement that increases no in the body, i.e., nitrate-rich beetroot juice, improves vascular, motor and cognitive function in patients with ckd; this study will also provide insight into the biological reasons (mechanisms) by which supplementation with nitrate-rich beetroot juice improves vascular function in these patients. overall, this research will provide scientific evidence supporting the use of nitrate-rich beetroot juice for preserving physiological function and preventing co-morbid clinical conditions and disability in ckd.


Eligibility criteria:
inclusion criteria: * ckd stage ii-iv (egfr using the modification of diet in renal disease (mdrd) prediction equation 20-90 ml/min/1.73m2; stable renal function in the past 3 months) * ability to give informed consent * albumin \> 3.0 g/dl * ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 6 min, climb 10 stairs) * free from alcohol dependence or abuse, as defined by the american psychiatry association, diagnostic and statistical manual of mental disorders (dsm-v) * mini-mental state examination score \>21 (rationale: to screen for subjects with major cognitive impairment) * blood pressure (bp) \>100/60 mmhg for past 3 months (rationale: blood pressure below 100/60 mmhg may elevate the normally small risk of hypotension with nitrate supplementation) * not taking medications that will interfere with administered medications (e.g., sildenafil interacts with nitroglycerin) * body mass index (bmi) \<40 kg/m2 (vascular function measurements can be inaccurate in severely obese patients) exclusion criteria: * life expectancy \<1 year * uncontrolled hypertension, defined as blood pressure \> 160/100 mmhg in the past 3 months * history of severe liver disease * history of severe congestive heart failure (i.e., ejection fraction \< 35%) * history of hospitalizations within the last 3 months * active infection or antibiotic therapy * warfarin use * vasculitis requiring immunosuppressive therapy within the last year * high dietary nitrate intake or current nitrate/nitrite supplementation; hypersensitivity to nitrates or nitrites * glucose-6-phosphate dehydrogenase deficiency or blood methemoglobin \>2% * unwilling to abstain from use of mouthwash or other oral hygiene practices (e.g., tongue scraping) outside of teeth brushing that disrupt the oral microbiome and would interfere with nitrate conversion to nitrite * blood donation within 8 weeks prior to enrolling in the study; unwilling to abstain from donating blood for 8 weeks after completing the study
clinical trial of sl1904b car-t cells for relapsed or refractory non-hodgkin lymphoma

Conditions: Non-hodgkin's Lymphoma

Summary: this is a study of patients with relapsed or refractory non-hodgkin's lymphoma. to evaluate the safety and efficacy of sl1904b in patients with relapsed or refractory non-hodgkin's lymphoma.

the cars consist of an anti-cd19 single-chain variable fragment（scfv） that was derived from the fmc63 mouse hybridoma, a portion of the human cd137（4-1bb） molecule, and the intracellular component of the human cd3ζ molecule. prior to car-t cell infusion, the patients will be subjected to preconditioning treatment. after car-t cell infusion, the patients will be evaluated for adverse reactions and efficacy. the main research objectives: to evaluate the safety and efficacy of sl1904b in patients with recurrent or refractory non-hodgkin's lymphoma the secondary research objectives: to investigate the cytokinetic characteristics of sl1904b in patients with recurrent or refractory non-hodgkin's lymphoma.

Eligibility criteria:
inclusion criteria: 1. sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2. the diagnosis of patients with relapsed or refractory non-hodgkin lymphoma; 3. there should be at least one measurable tumor focus according to the recist version 1.1; 4. ecog scores: 0\~2; 5. the expression of cd19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry; 6. estimated survival time was longer than 3 months; 7. main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (uln); alt uln 2.5 or less; ast uln 2.5 or less; total bilirubin ≤ 1.5uln; left ventricular ejection fraction (lvef) ≥45%; hemoglobin ≥90g/l; platelet count ≥50×109/l; absolute neutrophil count (anc) ≥1.0×109/l; blood oxygen saturation \>92%； 8. peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment. exclusion criteria: 1. serious cardiac insufficiency； 2. has a history of severe pulmonary function damaging; 3. with other tumors which is/are in advanced malignant and has/have systemic metastasis; 4. merging the metabolic diseases (except diabetes); 5. merging severe autoimmune diseases or immunodeficiency disease; 6. patients with active hepatitis b or hepatitis c virus infection; 7. patients with hiv infection or syphilis infection; 8. has a history of serious allergies on biological products (including antibiotics); 9. participated in any other clinical drug trial for the last six months; 10. being pregnant and lactating or having pregnancy within 12 months; 11. with other uncontrolled diseases and considered not suitable to participate by the researchers; 12. any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Keywords: nhl，cd19
tetraspan 6 percent (%) combined with sterofundin iso versus albumin 5 percent (%) combined with sodium chloride (nacl)

Conditions: Renal Insufficiency

Summary: this investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.


Eligibility criteria:
inclusion: * male or female patients * ≥ 50 years of age; * patients with compromised renal function, i.e. serum creatinine between 1.5 mg/dl and 3.0 mg/dl; * patients scheduled for elective intervention; * patients with an estimated intraoperative volume need of at least 1 l colloids; * provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the institutional ethics committee (iec) prior to all evaluations exclusion: * patients of asa-class \> iii; * patients with daily urine output \< 1 l; * patients on haemodialysis; * patients receiving hes during the last 48 hours before first infusion of the investigational products; * patients suffering from coagulation disorders (i.e. ptt \> 60 sec); * patients with a hemoglobin \< 9 g/dl; * patients with known hypersensitivity to hes, albumin or any of the excipients; * patients suffering from contraindications of the investigational products (i.e. hyperhydration state including pulmonary oedema, renal failure with oliguria or anuria, intracranial haemorrhage, hyperkalaemia, severe hypernatraemia or severe hyperchloraemia, severely impaired hepatic function, congestive heart failure); * simultaneous participation in another clinical trial; emergencies; * patients scheduled for brain surgery; * patients incapable to give informed consent (e.g. patients with dementia, psychiatric diseases or suffering from conditions associated with lack of consciousness)
identification of factors associated with physical activity levels in adult muscle diseases

Conditions: Muscle Disease

Summary: to evaluate physical activity levels and factors associated with physical activity levels in adult patients with muscle diseases.

the same protocol will be applied all of the patients and healthy subjects. individuals will be informed in detail about the study and demographic and physical properties will recorded after receiving approval. evaluation programme that consisting of pain, fatigue, falls, activity limitations, quality of life, muscle strength assessment and functional assessment will be applied. after the evaluation, individuals will be given detailed information on the use of sensewear activity monitors. individuals will wear sensewear activity monitors on right triceps muscle for 5 days. the data stored on the device will be recorded in computer using the software. individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity). physical activity levels will be assessed by subjective aspects of physical activity questionnaire.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of muscle diseases * adult patients with muscle diseases who are able to walk independently exclusion criteria: * clinical diagnosis of systemic problems * any orthopedic problems that will affect the performance of the physical activity * clinical diagnosis of neurological disease other than muscle disease * clinical diagnosis of cognitive impairment * individuals who underwent surgery in the last 6 month
comparing the ultrasound appearance of the sciatic nerve with its appearance under a microscope

Conditions: Diabetes

Summary: the investigators are proposing to conduct this study to compare the ultrasonographic appearance of the sciatic nerve with their corresponding histologic architecture. patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled. we intend to do an ultrasound examination of the sciatic nerve at its bifurcation (about 4 inches above the knee). the investigators would mark the area on the skin where the image is obtained. following surgery we will conduct a histologic examination of the nerve at the same site. ultrasound examination is not standard of care, but is a fairly noninvasive procedure and does not add any risk to the subject. histologic examination of the nerve is also not standard of care, but is conducted on a pathology specimen


Eligibility criteria:
inclusion criteria: * diabetes * patients that are scheduled to undergo above knee amputation due to complications associated with diabetes exclusion criteria: * minors

Keywords: above knee amputation sciatic nerve ultrasonography histology
bacterial composition and immune responses in the nose and oropharynx during influenza infection

Conditions: Influenza

Summary: this study will serve to determine how influenza infection alters the bacterial colonization patterns in the nasal and oropharyngeal compartments, and whether the immune response correlate with these alterations. the investigators will be determining bacterial composition and immune responses in the nose and oropharynx during influenza infection. specific aims therefore, the overall aims of this study are as follows: 1. to identify baseline composition and kinetic changes in the nasal and oropharyngeal microflora and immune responses after administering intranasal live attenuated influenza virus (i.e., flumist® vaccine) or saline mist to healthy subjects; 2. to identify nasal and oropharyngeal microbial composition and local immune responses during influenza infections and after resolution of infection, and correlate these changes with clinical outcomes.

randomization and post-randomization visits after undergoing the nasal swabs and nasopharyngeal washes, and nasal epithelial brushing, healthy volunteers will be randomly assigned to receive either saline nasal spray (placebo) or flumist® nasal influenza vaccine (live attenuated influenza vaccine, or laiv). they will return 1-2 weeks and 4-6 weeks later to repeat the nasal swabs and nasopharyngeal washes, and nasal epithelial brushings done at the enrollment visit. samples will be processed to isolate 16s bacterial rna and host rna. 16s rrna will be analyzed by 16s sequencing for to determine the composition of the bacterial microbiome pre and post laiv or saline (placebo) administration. host immune responses will be assessed based upon microarray analysis of host rna pre and post laiv or saline administration.

Eligibility criteria:
inclusion criteria: * healthy volunteers: * healthy subjects between the ages of 18 and 65. approximately half of the subjects will be female and approximately half will be male. * must be eligible to receive live-attenuated nasal version of the influenza vaccine. * must be able to provide signed and dated informed consent. * healthy subjects willing and able to provide oropharyngeal and nasal cavity specimens exclusion criteria: * immunosuppressive conditions or medications * chronic systemic medical illness * infections or antibiotic use within the past 60 days

Keywords: immunology microbiota
effects of left atrial appendage resection and marshall ligament amputation on clinical outcome in patients undergoing off-pump coronary artery bypass

Conditions: Coronary Artery Disease; Stroke; Atrial Fibrillation

Summary: surgical occlusion of the left atrial appendage (laao) is sometimes performed during the cardiac surgery to reduce long-term risk of stroke.a previous study found that laao may be associated with increased risk of postoperative atrial fibrillation.new-onset atrial fibrillation (noaf) after coronary artery bypass graft is related to an increased short-term and long term risk of stroke and mortality.marshall ligament amputation may reduce the occurence of atrial fibrillation. however, little is known whether this approach is justified during the coronary artery bypass graft.therefore, this study aimed to investigate whether laao and marshall ligament amputation during off-pump coronary artery bypass was associated with reduced risks of postoperative new-onset atrial fibrillation and stroke.


Eligibility criteria:
inclusion criteria: * isolated first off-pump coronary artery bypass exclusion criteria: * preoperative atrial fibrillation or a history of atrial fibrillation; * concurrent cardiac or non-cardiac surgery * intraoperative convert to bypass bypass surgery * emergency surgery * history of previous cardiac surgery * severe organ dysfunction

Keywords: off-pump coronary artery bypass postoperative new-onset atrial fibrillation left atrial appendage marshall ligament
a randomized, controlled, safety and tolerability study of vrdn-001 in participants with thyroid eye disease (ted)

Conditions: Thyroid Eye Disease

Summary: the investigational drug, vrdn-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (igf-1r). inhibition of igf-1r may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (ted). the primary objective of this clinical trial is to evaluate the safety and tolerability of vrdn-001 in patients with ted.

a randomized, controlled, safety and tolerability study of vrdn-001, a humanized monoclonal antibody directed against the igf-1 receptor, in participants with thyroid eye disease (ted).

Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of ted with or without proptosis and with any cas (0 - 7) and in the opinion of the investigator may benefit from treatment * must agree to use highly effective contraception method as specified in the protocol * female ted participants must have a negative serum pregnancy test * not require immediate ophthalmological or orbital surgery in the study eye for any reason exclusion criteria: * must not have received prior treatment with another anti-igf-1r therapy * must not have used systemic corticosteroids, or selenium within 2 weeks prior to day 1 * must not have received rituximab, tocilizumab or other immunosuppressive agents within 8 weeks prior to day 1 * must not have received any other therapy for ted within 8 weeks prior to day 1 * must not have received an investigational agent for any condition within 8 weeks prior to the first dose of study medication * must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the investigator would confound interpretation of the study results * must not have had previous orbital irradiation or decompression surgery involving excision of fat for ted in the study eye's orbit * must not have inflammatory bowel disease * must not have abnormal hearing test before first dose. must also not have a history of ear conditions considered significant by study doctor. * must not have received an investigational agent for any condition within 8 weeks prior to day 1 * female ted participants must not be pregnant or lactating

Keywords: graves thyroid eye disease thyroid-associated ophthalmopathy dysthyroid ophthalmopathy graves eye disease graves orbitopathy myopathic ophthalmopathy congestive ophthalmopathy edematous ophthalmopathy infiltrative ophthalmopathy
post anesthesia emergence and behavioral changes in children undergoing mri

Conditions: Delirium on Emergence

Summary: children who receive general anesthesia may become agitated (emergence delirium) in the recovery period. this occurs more often after inhalational anesthetics, particularly sevoflurane and desflurane than after propofol. however, agitation after anesthesia in children may be difficult to distinguish from pain; accordingly studies are ideally designed during mri to obviate the contribution of pain during emergence. airway complications have been reported after lma and isoflurane more commonly than with iv propofol and nasal prongs. whether the airway complications were due to the lma or the isoflurane was unclear. therefore, this study was designed to study the incidence of 1. agitation after sevoflurane compared with iv propofol and 2. airway complications after lma or nasal prongs.

180 children, asa physical status 1 or 2 will be recruited for elective mri scan. randomized after consent is obtained to one of four groups. anxiety will be assessed preoperatively using the modified yale preoperative anxiety scale. children will be accompanied by one parent to mri scanner where monitors are applied. all children will have anesthesia induced with nitrous oxide and oxygen followed by sevoflurane until iv is established. thereupon, they will be managed by their randomization assignment. the propofol pump will be concealed at all times. if propofol was used, it will be disconnected from the patient and residual propofol in the line flushed so prevent unblinding the patient's assignment. a blinded observer will be present to evaluate the patient when emergence begins. the single blinded observer will follow the patient from the mri scanner through recovery room evaluating vital signs as well as emergence delirium (using the paed scale). a paed score \> 12 at any time during emergence period will confirm the diagnosis of emergence delirium. after discharge from hospital, a post-discharge questionnaire will be completed at 12, 24 and 48 hours after discharge. all parents will be called to retrieve the questionnaire results after 48 hours after discharge from hospital.

Eligibility criteria:
inclusion criteria: * age 2-12yrs, * asa class i-ii, * fasting, * unmedicated, * elective mri scan exclusion criteria: * cognitive impairment, * on psychotropic medications, * taking multiple (\>2) antiepileptic medications, * requiring endotracheal intubation for ga

Keywords: children sevoflurane isoflurane propofol anesthesia mri delirium