Kornimate/medical-research-clean huggingface dataset:
comparing air embolic load in two venous cannulation methods, 40 patients undergoing elective valve surgery.

Conditions: Extracorporeal Circulation; Complications; Air Embolism

Summary: the goal of this single center prospective controlled observational and interventional trial is to investigate and compare origin of air emboli when different venous cannulation methods is used in patients undergoing cardiac surgery with extracorporeal circulation. 40 consecutive elective patients will be included in two groups, depending on the procedure requiring bicaval or cavoatrial cannulation. after assorted into respective group, patients will be block randomized (five groups consisting of eight patients each) to either intervention group (low venous reservoir volume, 200-300 ml) or control group (venous reservoir volume \> 300 ml). primary endpoint is to investigate if the amount of air emboli passing through the oxygenator to the arterial line differs between bicaval and cavoatrial venous cannulation during extracorporeal circulation. secondary endpoints are the relative difference in amount air emboli between the groups, if there is any correlation between the amount of air in venous line and the amount of air passing through the oxygenator to the arterial line during extracorporeal circulation, and if difference is seen on the amount of air passing through the oxygenator depending on the level of volume in the venous reservoir.


Eligibility criteria:
inclusion criteria: * patients \> 18 years * elective bicaval cannulation (mitral valve repair/replacement (mvr) or mvr + coronary artery bypass grafting (cabg)) * elective cavoatrial cannulation (aortic valve repair/replacement (avr) or avr + cabg * planned normothermia (35-37˚c) exclusion criteria: * acute heart surgery * adult congenital heart disease (achd) surgery * endocarditis * reoperation (primary procedure \> 2 years ago) * perioperative iatrogenic adverse events (major bleeding, aortic dissection, other severe complications)
tele-health enabled clinical trial for covid-19

Conditions: SARS-CoV Infection

Summary: to determine the efficacy of high dose vitamin d (an over-the-counter nutritional supplement) in preventing immune-related complications in outpatients with confirmed sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. laboratory confirmed sars-cov-2 infection \< 4 days before randomization 3. report of symptoms consistent with sars-cov-2 infection (including but not limited to fever, cough, muscle aches, joint pain, change in taste, change in smell, or shortness of breath) \<4 days before admission 4. asymptomatic or mild symptoms (not requiring hospital admission) 5. access to and ability to use a mobile phone with telehealth capability exclusion criteria: 1. unable to provide informed consent or comply with study directions 2. admitted to an acute care bed 3. baseline serum calcium \ 10.2 mg/dl (as evaluated by labs taken in the er/urgent care) 4. women who are currently breastfeeding 5. history of kidney stone in the past year or h/o multiple (\>1) previous kidney stones 6. does not have a smart phone that can download apps from google play or app store. 7. no way to keep the phone charged consistently 8. the smartphone is shared with another individual. 9. required laboratory data is unavailable (eg calcium levels) 10. no new oxygen requirement (see remote monitoring document) 11. pregnant and lactating mothers. 12. vitamin d level of 80ng/ml and above 13. no lab work for calcium or vitamin d completed in ed

Keywords: vitamin d telehealth sars-cov-2 immune storm
teaching appropriate gestational weight gain

Conditions: Obesity

Summary: the study aims to improve obstetrical care by managing gestational weight gain (gwg) among high risk women in an effort to reduce maternal and fetal complications.

the project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in tagg. those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain. the primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.

Eligibility criteria:
inclusion criteria: * pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight) * less than 16 weeks gestation * gestational weight gain (gwg) less than \< 11 pounds from their pre-pregnancy weight to time of potential study enrollment * singleton gestation * access to a phone exclusion criteria: * bmi less than 30 kg/m2 * gestational age greater than or equal to 16 weeks * active diagnosis of cancer on their electronic health record problem list * acquired immunodeficiency syndrome (aids) * palliative medicine patients * multiple gestations * gwg in excess of 11 pounds prior to study enrollment * patients with non-geisinger prenatal care providers * vegan diet * malabsorptive conditions * previously enrolled in tagg during prior pregnancy. patient will be excluded from re-randomization * non-english speaking
study investigating a delayed-release pancrelipase in patients with pancreatic exocrine insufficiency due to cystic fibrosis

Conditions: Cystic Fibrosis; Pancreatic Exocrine Insufficiency

Summary: this study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with pancreatic exocrine insufficiency (pei) due to cystic fibrosis.


Eligibility criteria:
inclusion criteria: * confirmed cystic fibrosis (cf) diagnosis by two positive chloride sweat tests or gene analysis * current or historical human fecal elastase \< 50µg/gstool * weight greater than 3.75 kg * age 1 month to 6 years * currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months * clinically stable condition without evidence of acute respiratory disease or any other acute condition exclusion criteria: * ileus or acute abdomen * history of fibrosing colonopathy, celiac disease, gastrectomy, crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome * history of distal ileal obstruction syndrome within 6 months of enrollment * use of an immunosuppressive drug * any type of malignancy involving the digestive tract in the last 5 years * known infection with hiv

Keywords: cystic fibrosis pancreatic exocrine insufficiency
magnetic resonance imaging of the liver in children 0-2 months of age with an intravenous injection of eovist/primovist which is a contrast agent

Conditions: Magnetic Resonance Imaging

Summary: this is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). this agent is called eovist. it has been marketed since 2004 and used in many countries all over the world. the baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. the baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. several radiologists will evaluate the images. the family doctor will be contacted to find out what was the diagnosis and treatment after the results of the mri were known. six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.

in order to minimize bias in assessment of the images, blinded reading of the mr images will be performed by 2 blinded readers. the blinded readers will be independent board-certified pediatric radiologists who have no knowledge about the subjects and are not affiliated with any of the clinical sites.

Eligibility criteria:
inclusion criteria: * age 0-2 months (must be gestational age 37 to 41 weeks) * scheduled to undergo routine contrast-enhanced liver mri * able to comly with the study procedures exclusion criteria: * scheduled for any intervention (except lumbar puncture and bone marrow aspiration) during the study period * if receiving chemotherapy, may have a change in treatment during the study period * contraindication for mri * renal insufficiency (estimated glomerular filtration rate \< 80% of age-adjusted normal mean value using the schwartz formula) * acute renal failure * clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper limit of the normal range, in particular, liver enzymes and renal function. (note: if elevations in liver enzyme levels are consistent with the underlying hepatobiliary disease, then the subject may be enrolled.)
diagnosis of pelvic endometriosis in mri

Conditions: Endometriosis

Summary: purpose： evaluate the feasibility of r2 star multiple fast gradient recalled echo (r2\*mfgre) imaging in the diagnosis of pelvic endometriosis. one hundred patients with suspected endometriosis underwent routine pelvic mri and r2\*mfgre imaging. clinical diagnosis was pathologically confirmed one month after mri examination. three radiologists who were blinded to the pathological results evaluated the numbers of ovarian endometriomas (omas) and deep in-filtrating endometriosis (die) lesions using routine mri and its combination with r2\*mfgre. mri changes of lesion size before and after estrogen therapy.

this prospective study was approved by the ethics committee of the local hos-pital, and informed consent was obtained from all the patients in this study (3701027061515). all procedures performed in studies involving human participants were in accordance with the ethical standards of our institutional and national re-search committee and with the declaration of helsinki. study population one hundred and sixty-five patients with suspected endometriosis underwent pelvic mri with r2\*mfgre imaging from decemberr 2017 to december 2023. of those, one hundred and forty patients were submitted to surgical (either laparotomy or laparoscopy) treatment for endometriosis. the diagnosis was confirmed by pathology within one month after the initial mr exam. additionally, 20 out of 160 patients were excluded from the study. of these, 11 were due to non-surgical treatment, and the other 8 were due to prominent susceptibility artifacts caused by colonic overdistention, limiting the vis-ibility of the pelvis. finally, one hundred patients were included in the study. all 100 patients were aged ranging from 24 to 54 years, with an average age of 37.8 years. their clinical symptoms included dysmenorrhea, bulging in the lower abdomen or anus, heavy menstrual bleeding, dyspareunia, and infertility. some of these patients had multiple symptoms

Eligibility criteria:
inclusion criteria: * patients who proven endometriosis by pathology patients who wish to be treated exclusion criteria: * received any treatment (radiotherapy, chemotherapy, surgery or chemoradiotherapy) before undergoing imaging studies poor-quality mr images with any severe motion or artifacts
toripalimab or placebo as adjuvant therapy in hepatocellular carcinoma after radical resection

Conditions: Hepatocellular Carcinoma

Summary: this study will investigate if toripalimab (a pd-1 inhibitor) will improve recurrence-free survival (rfs) compared to placebo in participants with hcc and are at high risk of recurrence after complete resection with no residual of tumour.


Eligibility criteria:
inclusion criteria: 1. hcc with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received r0 resection; 2. bicr confirmed no resdual tumor lesions are detected in liver; 3. child-puch score, class a; 4. ecog score is 0; exclusion criteria: 1. patients previously received pd-1 antibody, pd-l1 antibody, pd-l2 antibody or ctla-4 antibodies, including those who have participated in the js001 clinical study; 2. portal vein tumor thrombi or liver metastases or recurrent liver cancer; 3. with symptoms of central nervous system metastasis; 4. with any history of active autoimmune disease or autoimmune disease; 5. known liver diseases with clinical significance; 6. patients infected by hepatitis b virus (hbv), hepatitis c virus (hcv), hepatitis d virus (hdv): other protocol defined inclusion/exclusion criteria could apply
a study to evaluate the efficacy and safety of br1017a and br1017b combination therapy in essential hypertension patients with primary hypercholesterolemia

Conditions: Essential Hypertension; Primary Hypercholesterolemia

Summary: the objective of this clinical study is to evaluate the efficacy and safety by comparing br1017a+br1017b treatment group to br1017a treatment group and br1017b treatment group respectively at week 8 in essential hypertension patients with primary hypercholesterolemia


Eligibility criteria:
\ screening * patients with essential hypertension and primary hypercholesterolemia * if patients are being treated with antihypertensive/antihyperlipidemic drugs at screening (v1), they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/ antihyperlipidemic drugs during the clinical trial * patients who have an fasting triglyceride (tg) \< 400 mg/dl and ldl-c ≤ 250 mg/dl at screening (v1) * voluntarily provided a written consent to participate in this clinical study * able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion randomization * patients who meet the following criteria of blood pressure measured in selected reference arm before randomization at baseline(v3) * 140 mmhg ≤ mssbp \< 180 mmhg * msdbp \< 110 mmhg * patients who meet the criteria of fasting serum lipid levels and risk factors at pre-baseline (v2) after undergoing the therapeutic lifestyle change (tlc) * patients who have an fasting triglyceride (tg) \< 400 mg/dl and ldl-c ≤ 250 mg/dl after undergoing the therapeutic lifestyle change (tlc) for at least 4 weeks before pre-baseline (v2) \ * patients with blood pressure results showing mssbp ≥ 180 mmhg or msdbp ≥ 110 mmhg in the selected reference arm at screening(v1) or baseline(v3) * patients with a difference of mssbp ≥ 20 mmhg and msdbp ≥ 10 mmhg in blood pressure measured three times on both arms at screening(v1) * patients with past history and comorbidities at screening(v1) under the following criteria: * patients with secondary hypertension: secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) * patients with secondary hyperlipidemia: secondary hyperlipidemia is not limited to the following diseases; (e.g., chronic renal failure, nephrotic syndrome, obstructive liver disease, hypothyroidism, dysproteinemia, etc.) * patients with orthostatic hypotension accompanied by symptoms
different immunosuppressive treatment in imn

Conditions: Idiopathic Membranous Nephropathy

Summary: the primary objective of this study is to compare the 24 month remission of different immunosuppressive therapies in the treatment of idiopathic membranous nephropathy (imn)

to date, the first-line immunosuppressive immunosuppressive therapy of imn includes corticosteroids combined with cyclophosphamide or rituximab (rtx). in recent randomized trials (mentor, gemritux), the long-term remission rate of rtx is about 60%, which is similar to the remission rate of cyclophosphamide combined with corticosteroids in early studies. but there is only one published randomized trial (starmen) comparing the efficacy of the two protocols head-to-head. in stramen trial, the long-term remission rate of cyclophosphamide+corticosteroids group was 83%, which was significantly higher than the that (58%) of the tacrolimus-rtx group. but in stramen trial, only one single dose of rtx was given which might influence the efficacy of the tacrolimus-rtx arm. therefore, head-to-head comparison of rtx (more than one dose) and cyclophosphamide+corticosteroid is needed. the optimal dose of rtx in the treatment of imn is unclear. in mentor trial, rtx was given 1g on d1 and d15, and the rate of complete remission at 6 month was 0, so rtx was repeated at 6 month. based on the experience of our center, most patients need at least one repeated dose of rtx at 6 month. based on the previous rationale, the investigators designed this study to compare the efficacy of cyclophosphamide plus corticosteroids with rtx in the treatment of imn.

Eligibility criteria:
inclusion criteria: * idiopathic membranous nephropathy * female, must be post-menopausal, sterile or have effective contraception * must be off steroid or mycophenolate mofetil for \>1 month and alkylating agents for or rtx\> 6 months * angiotensin-converting-enzyme inhibitor (acei) or angiotensin receptor blocker (arb) for ≥ 3 months with controlled blood pressure prior to beginning of immunosuppressive therapy or if patients are intolerant to acei/arb. * proteinuria ≥4g/24h and decreased ≤ 50% from baseline exclusion criteria: * presence of active infection or a secondary cause of membranous nephropathy * proteinuria associated with diabetic nephropathy * pregnancy or breast feeding * history of resistance to rituximab or alkylating agents or corticosteroid * patients who previously achieved remission after treatment of rituximab or alkylating agents but relapsed off rituximab or alkylating agents after 6 months are eligible.
a study for patients with rheumatoid arthritis on methotrexate (mtx) with an inadequate response to tnfα inhibitor therapy

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to explore whether ly2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (ra) in patients with a history of inadequate response or intolerance to at least 1 tumor necrosis factor-alpha (tnfα) inhibitor therapy. examples of these tnfα inhibitor therapies that are currently on the market include enbrel® (etanercept), remicade® (infliximab), and humira® (adalimumab).


Eligibility criteria:
inclusion criteria: * have given written informed consent approval * women must not be at risk to become pregnant during study participation * diagnosis of rheumatoid arthritis * active rheumatoid arthritis * current, regular use of methotrexate, at a stable dose * have been on at least 1 biologic tumor necrosis factor-alpha (tnfα) inhibitor therapy and either failed or were intolerant to treatment * other criteria to be reviewed by study doctor exclusion criteria: * use of excluded medications (reviewed by study doctor) * have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study * have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation * evidence of tuberculosis * have systemic inflammatory condition other than rheumatoid arthritis (ra), such as juvenile ra, seronegative spondyloarthropathy, crohn's disease, ulcerative colitis, or psoriatic arthritis. * other criteria to be reviewed by study doctor
risk of developing antibodies to heparin-pf4 after heart surgery

Conditions: Thrombosis

Summary: heparin is a drug that is widely used to prevent and treat blood clotting. individuals undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of them develop antibodies to the drug. this immune response can lead to the formation of blood clots, setting the stage for a potential heart attack or stroke. the purpose of this study is to evaluate how often an immune response to heparin leads to the formation of blood clots in individuals who have had heart surgery.

heparin is a drug that is widely used to prevent and treat blood clotting. however, heparin can also cause serious adverse events. individuals undergoing cardiopulmonary bypass surgery are administered and therefore exposed to high doses of heparin. studies have shown that up to 61% of cardiac bypass patients develop elevated levels of antibodies to heparin-pf4 after surgery. this immune response may activate blood platelets, possibly resulting in a blood clot. these clots most often develop in the legs and lungs, and may lead to a heart attack or stroke. the frequency of such a reaction has yet to be determined definitively. this study will evaluate the incidence of an immune response to heparin-pf4 that leads to the formation of blood clots in individuals who have had heart surgery. participants in this study will be recruited prior to a scheduled cardiac bypass surgery. they will first complete a structured pre-operative interview to collect baseline measures on demographics, comorbidities, history of heparin exposures, and prior thromboembolic events. immediately prior to surgery, a blood sample will be taken to assess the individual's platelet count and level of antibodies to heparin-pf4. following the operation, participants will be followed daily to assess heparin exposure, platelet counts, and any blood clotting. subsequent blood samples will be taken 5 days and 1 month following the surgery to again evaluate the individual's platelet count and level of heparin-pf4 antibodies. additionally, participants will undergo a structured interview at 1 and 3 months post-surgery to evaluate the incidence of outcomes related to heparin-pf4 antibodies.

Eligibility criteria:
inclusion criteria: * scheduled for cardiac bypass surgery at duke university hospital exclusion criteria: * plans to receive warfarin during the post-operative inpatient stay * plans to receive a full anticoagulant dose of low-molecular weight heparin during the post-operative inpatient stay * plans to receive a full anticoagulant dose of unfractionated heparin during the post-operative inpatient stay * use of any drug other than unfractionated heparin for anticoagulation during cardiopulmonary bypass * warfarin, heparin, or low-molecular weight heparin administered during a readmission to the hospital for a reason other than one of this study's outcomes does not constitute criteria for exclusion

Keywords: heparin resistance blood clotting heart surgery cardiopulmonary bypass