Kornimate/medical-research-clean huggingface dataset:
effect of iv acetaminophen on patients in the neurocritical care unit

Conditions: Post-operative Craniotomy Patients; Carotid Endarterectomy and Carotid Artery Stenosis Patients; Post-op Spine Patients Admitted to the NCCU; Endovascular Patients Undergoing Intracranial Intervention; Traumatic Brain Injuries NPO for at Least 12 Hours

Summary: to assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. to assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients. to assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.


Eligibility criteria:
inclusion criteria: * \> 45 kg (amenable to adult dosing) * all traumatic brain injuries npo for at least 12 hours * all post-operative craniotomy patients * all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients * all carotid endarterectomy and carotid artery stenosis patients * all endovascular patients undergoing intracranial intervention * all post-op spine patients admitted to the nccu exclusion criteria: * documented allergy to acetaminophen * documented severe hepatic impairment (child-pugh score \> 6) or severe hepatic disease (hepatitis) * documented severe renal impairment (crcl \< 30 ml/min) blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment. * patients who are pregnant or breast feeding

Keywords: craniotomy
study of the effects of yerba mate on cardiometabolic health

Conditions: Cardiovascular Risk; Hypercholerolemia

Summary: the goal of this clinical trial is to learn if consuming a beverage prepared with yerba mate leaves helps to improve blood lipid levels in persons at high cardiovascular risk. it will also learn about the effects of this beverage, widely consumed in south america, on other cardiometabolic biomarkers like blood glucose levels, inflammation, or weight control. the main questions it aims to answer are: does daily consumption of a yerba mate tea reduce the blood lipid levels in hypercholesterolemic persons? may healthy persons also benefit from the consumption of yerba mate tea? researchers will compare yerba mate to a control drink (isotonic drink or water, free of polyphenols and caffeine) to see if yerba mate tea helps to reduce blood cholesterol in hypercholesterolemic persons. participants will: drink 3 cups of yerba mate tea or an isotonic drink every day for 2 months, then change to the other drink during another 2 months. visit the clinic at the beginning and end of each 2-month period for checkups and tests refraing from consuming coffee and some foods during the study. complete a dietary questionnaire during 3 days before each visit to the clinic.

this is a randomized, crossover, control study in healthy and hypercholesterolemic free-living to assess the effect of yerba mate on different outcomes related to cardiovascular health. after a 2-week run-in period, participants will be randomly allocated to the first 8-weeks intervention with yerba mate or the control drink. after a 3-week wash-out, they will change to consume during 8 weeks the other drink. a nurse will collect a fasting blood sample at the beginning and end of each intervention stage. blood pressure and anthropometric parameters will be measured. a 72-h dietary record will be completed by participants before each visit to the human nutrition unit (hnu) at the institute of food science, technology and nutrition (ictan-csic). during the study, participants will refrain from consuming coffee, cocoa, tea, and caffeine-containing drinks. other foods rich in certain polyphenols (i.e. hydroxycinnamic acids) will also be restricted. blood samples will be used to measure different biomarkers of relevance in cardiometabolic health, as listed in the outcomes section.

Eligibility criteria:
inclusion criteria: * body mass index between 20-25 kg/m2 * total cholesterol \< 200 mg/dl for healthy participants, between 200-240 mg/dl for participants at cardiovascular risk, or * ldl cholesterol \< 130 mg/dl for healthy participants, between 130-159 mg/dl for participants at cardiovascular risk. exclusion criteria: * smoking * pregnant/lactating women * vegetarians/vegans * consumption of vitamins or dietary supplements * suffering from chronic diseases/pathologies/conditions appart from hypercholesterolemia * on prescription drugs (statins) or on antibiotics 6 months before the study

Keywords: yerba mate cardiovascular health inflammation blood lipids glucose homeostasis
a study to evaluate the safety and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with nras-mutant advanced melanoma.

Conditions: Melanoma

Summary: this study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with nras-mutant advanced melanoma who have received anti-pd-1/pd-l1 therapy.

the study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (belva arm); a belvarafenib plus cobimetinib arm (belva + cobi arm) in an initial dose-finding phase followed by an expansion phase and a belvarafenib plus cobimetinib plus nivolumab arm (belva + cobi + nivo arm) in a run-in phase followed by an expansion phase.

Eligibility criteria:
inclusion criteria: * ecog performance status of 0 or 1 * histologically confirmed, metastatic (recurrent or de novo stage iv) or unresectable locally advanced (stage iii) cutaneous melanoma, that has progressed on or after treatment with anti-pd-1 or anti-pd-l1 therapy. patients may have received up to two lines of systemic cancer therapy. treatment with anti-pd-1/pd-l1 in the adjuvant setting is acceptable. patients must have progressed disease at study entry * documentation of nras mutation-positive within 5 years prior to screening * tumor specimen availability * adequate hematologic and end-organ function * measurable disease per recist v1.1 exclusion criteria: * prior treatment with a pan-raf inhibitor * treatment with systemic immunotherapy agents (e.g., anti-ctla4, anti-pd(l)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to c1d1 * symptomatic, untreated, or actively progressing cns metastases * history or signs/symptoms of clinically significant cardiovascular disease * known clinically significant liver disease * history of autoimmune disease or immune deficiency * prior treatment with a mek inhibitor (cobimetinib arm) * history of or evidence of retinal pathology on ophthalmologic examination (cobimetinib arm) * history of immune-related ae attributed to prior anti-pd(l)1 therapy that resulted in permanent discontinuation of anti-pd(l)1 therapy (nivolumab arm)
prospective collection of whole blood from active non-small cell lung cancer patients for supplemental research

Conditions: Non Small Cell Lung Cancer

Summary: the study objective is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with active lung cancer to investigate the immune response to develop treatments and therapies.


Eligibility criteria:
inclusion criteria: * participants willing and able to provide written informed consent * participants are willing and able to provide appropriate photo identification * participant's age 18 - 100 years old * participants diagnosed with active non-small cell lung cancer (adenocarcinoma or squamous cell only. all stages are acceptable.) * participants must have associated tissue biomarker data (efgr and met mutations) in their medical records exclusion criteria: * participants who are pregnant or nursing * participants with a known history of hiv, hepatitis, or other infectious diseases * participants who have taken an investigational product in the last 30 days * participants who have experienced excess blood loss, including blood donation defined as 250 ml in the last month or 500 ml in the previous two months * participants currently enrolled in a clinical trial * participants currently in remission

Keywords: lung cancer nsclc
value of additional upfront systematic lung ultrasound in the workup of patients with unilateral pleural effusion

Conditions: Pleural Effusion; Malignant Pleural Effusion; Ultrasound

Summary: the value of lung ultrasound in the work up of pleural effusion (fluid in between the thin doublet layered film surrounding the lungs) is unknown. the researchers will perform a systematic lung ultrasound scan including a scan for extra thoracic metastasis (spread of cancer to other organs) in the lymphnodes of the neck and metastasis lever in 56 patients one-sided pleural effusion. the researchers will measure if the interventions change the diagnostic plan for the patient and leads to faster diagnostics of the underlying course.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * unilateral pleural effusion of unknown course. * patients must be able to give informed consent. exclusion criteria: * bilateral pleural effusions. * known cause of pleural effusions. * life expectancy \<3 months. * inability to understand written or spoken danish.
ast-120 used to treat mild hepatic encephalopathy

Conditions: Mild Hepatic Encephalopathy

Summary: the purpose of this study is to determine whether ast-120 is safe and effective in the treatment of mild hepatic encephalopathy.


Eligibility criteria:
inclusion criteria: 1. confirmed cirrhosis of any cause 2. abnormal rbans global summary score 3. grade 0 or 1 hepatic encephalopathy by west-haven scale 4. meld score \< or = 25 5. females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control exclusion criteria: 1. previous participation in any trial involving ast-120 2. history of tips or surgically created portocaval shunt 3. treatment for overt he within the past 3 months 4. use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days 5. active alcohol abuse 6. psychosis or organic brain syndromes due to alcohol or other causes 7. use of interferon and sedating or cognition-altering drugs 8. undergoing chemotherapy or radiotherapy for the treatment of cancer 9. active gi bleeding within the past 3 months 10. presence of an active infection 11. presence of signs and symptoms of severe dehydration 12. other major physical or major psychiatric illness within the past 6 months 13. pregnant, breast feeding, or planning to become pregnant during the study 14. using hormonal contraception as the only method of birth control

Keywords: hepatic encephalopathy mild hepatic encephalopathy he mhe cognitive impairment cognitive dysfunction liver disease cirrhosis
transfusion of biotinylated red blood cells

Conditions: Anemia

Summary: the purpose of this research is to study how red blood cells (rbcs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. investigators will study this by collecting blood samples from participants, "labeling" rbcs with a naturally occurring vitamin, biotin. the rbcs will then be re-infused back into the participant and blood samples will be taken weekly for 10 weeks to assess the number of labeled cells in the samples.

the purpose of this research is to study how red blood cells (rbcs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. in this study, blood is collected from healthy subjects, processed into packed red blood cell units, and either immediately afterwards or 40-42 days later the packed red blood cells are labeled with biotin. the biotin-labeled red blood cells are then re-infused back to the donor (autologous transfusion). blood samples are then taken from the subject every week for up to 70 days (10 weeks) to track survival of the labeled red blood cells. this study also seeks to demonstrate that biotin-labeled rbcs can be safely transfused back to autologous subjects without any adverse reactions. all participants will be followed to watch for the development of antibodies against biotin-labeled rbcs.

Eligibility criteria:
inclusion criteria: * in good health exclusion criteria: * anemia (defined as hemoglobin \< 8 g/dl) * chronic disease, including diabetes, heart or lung disease, poorly managed hypertension, and peripheral vascular disease * ongoing consumption of biotin or raw egg supplements * history of a bleeding disorder * evidence of anemia at initial screening * women who are pregnant or plan to become pregnant

Keywords: red blood cell (rbc) transfusion biotin labeled red blood cells
effect of autologous cord blood-mononuclear cells infusion on immune microenvironment in infants born very preterm in nicu

Conditions: Immunomodulation Effect

Summary: multi-omics (analysis of peripheral blood immune cells subset, peripheral blood mncs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with intravenous acbmnc infusion in very preterm monozygotic twins

this was a randomized, placebo-controlled, double-blinded trial involving eight pairs of vpmts who were admitted to nicu to receive respiratory support right after birth. the infants were assigned (1:1) to receiving at least 2×107 acb-mncs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair. multi-omics (analysis of peripheral blood immune cells subset, peripheral blood mncs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with acb-mncs infusion, along with paired controls. feasibility, safety and clinical outcomes improvement of the acb-mncs infusion in both short and long term were also assessed.

Eligibility criteria:
inclusion criteria 1. born at study hospitals; 2. monozygotic twins (confirmed by ultrasonographic diagnosis before birth and confirm again with obstetricians during and after delivery, as monochorionic diamniotic twins and monochorionic monoamniotic twins twins were both monozygotic twins, therefore they will be both eligible); 3. gestational age (ga) \<32 weeks (ga was calculated based on the date of the last menstrual period of the mother and an ultrasonographic screening performed during the first trimester of pregnancy); 4. enrolled within the first 24 postnatal hours; 5. free of severe perinatal asphyxia (defined as an apgar score of 0-3 for more than 5 minutes, a cord blood gas ph \<7.00, or both); 6. free of severe congenital anomalies or genetic syndromes; 7. free of maternal sepsis24,25; 8. written informed consent is obtained from the parents or guardians of the infants; 9. either of the twins has available umbilical cord blood (ucb) , and the cell number was no more than 10×107 cells per kilogram, but should not be less than 2×107 cells per kilogram. exclusion criteria (1) they exhibit severe congenital abnormalities (detected via prenatal ultrasound); (2) expected to die within the first 24 hours; (3) diagnosed with severe twin-to-twin transfusion syndrome confirmed by prenatal ultrasonography24.

Keywords: autologous cord blood mononuclear cells monozygotic twins very premature infants
blood proteins in finding pancreatic cancer and extrahepatic biliary tract cancer

Conditions: Extrahepatic Bile Duct Cancer; Pancreatic Cancer

Summary: rationale: studying samples of blood in the laboratory from patients with cancer and from healthy participants may help doctors identify and learn more about proteins related to cancer. it may also help doctors tell whether a patient has cancer. purpose: this clinical trial is looking at proteins in blood samples to see how well they work in finding pancreatic cancer and extrahepatic biliary tract cancer.

objectives: * to explore the utility of the serum proteome pattern for early detection and diagnosis of pancreatic and extraheptic biliary tract cancer by analyzing serum samples from participants previously enrolled in the pankras-ii study. * to support efforts to contact participants (recruited to the pankras-ii study 10 years ago) who were diagnosed with benign biliary-pancreatic disease in order to discern if they subsequently developed a malignant biliary-pancreatic tumor. * to gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples by performing a review of clinical records of participants. outline: serum samples are analyzed for proteome pattern. participants undergo a telephone interview about their medical history (i.e., pancreatic or biliary tract disease diagnosed within the past 10 years). medical records are reviewed to gather information about clinical factors surrounding the date of blood extraction that may influence the proteomic patterns of the blood samples.

Eligibility criteria:
disease characteristics: * serum samples available from participants meeting any of the following criteria: * diagnosis of pancreatic or extrahepatic biliary tract cancer * suspected of having pancreatic or extraheptic biliary tract cancer, including pathologies (e.g., chronic pancreatitis) that might represent pre-neoplastic stages of the malignant disease * healthy control * previously enrolled on the pankras-ii study * recruited to study 10 years ago patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: pancreatic cancer extrahepatic bile duct cancer
needle-x: usability testing of a smartphone application

Conditions: Opioid Dependence

Summary: mobile health interventions offer a longitudinal approach to reducing the burden of substance use disorders and may stem the rise of the opioid overdose epidemic. smartphone applications are one of the most popular mobile phone features nationally, among patients in addiction treatment, and among criminal justice involved (cji) patients enrolled in addiction treatment. this research conducted at bellevue hospital's inpatient detoxification program established attitudes and self-reported behaviors favorable to theoretical smartphone applications addressing opioid use, hiv, and hcv prevention and management strategies. this study aims to assess the feasibility and usability of a smartphone application to enhance access to sterile needles, naloxone overdose kits, and addiction treatment programs in new york city.


Eligibility criteria:
inclusion criteria: * fluent in spoken and written english; * meets or has previously met dsm-5 criteria for current opioid use disorder, of at least moderate severity; * owns or has owned a smartphone exclusion criteria: * any patient who does not meet the inclusion criteria as above, is clinically unstable per the unit admitting physicians, refuses to participate in the study, or is cognitively impaired.
outcomes of injections in patients waiting for total knee replacement

Conditions: Osteoarthritis of the Knee

Summary: a comparison of intraarticular administration of hylan gf20, triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.

the objective of this research is to evaluate the short-term results of viscosupplementation in patients with advanced osteoarthritis of the knee. there is a bigger demand of patients requiring total knee arthroplasty than the number of surgeries performed by the unified health system in brazil. for this reason the queues to perform this surgery are huge and time-consuming in the referral hospitals. whereas all these patients are suffering from severe pain and limiting, and awaiting the surgery for a few years, it is necessary to try any treatment, even if temporary, to ease the pain and suffering of those patients. a double-blind randomized prospective study will be held at hospital federal dos servidores do estado do rio de janeiro, with patients from the waiting list for total knee arthroplasty who accept to participate and sign the informed consent form. will be selected the last 150 knees in tka queue. patients will be randomized and divided in 3 groups of 50 knees. a group will be submitted to an intraarticular injection of corticosteroid (1 ml of sterile triamcinolone hexacetonide solution 20 mg/ml). a second group will be subjected to administration of 6 ml of hylan gf20. the third group will receive hylan gf20 associated with corticosteroid (7 ml solution containing 1 ml of triamcinolone and 6 ml of hylan gf20). the injection technique will be the same for all patients. the outcome results will be measured by a form with patient data, functional scores (knee society score and lysholm) before treatment and at one, three and six months after treatment.

Eligibility criteria:
inclusion criteria: * over 18 years old; * waiting for total knee arthroplasty (at hospital federal dos servidores queue); * acceptance and signature of the tfcc; exclusion criteria: * infiltration of the knee for the past 6 months; * allergic to any substance used in the study; * prior infection in the knee.

Keywords: osteoarthritis knee treatment
transcranial doppler for reduction of silent stroke during mitraclip implantation

Conditions: Mitral Valve Insufficiency

Summary: the primary goal of the tcd-reduce study is to demonstrate the effectiveness of continuous transcranial doppler sonography ("sonolysis") on the reduction of the ischemic stroke volume during mitraclip implantation.

cardiac procedures are associated with new cerebral ischemic lesions detected on diffusion-weighted mri (bendszus et al., 2006). a previous study suggests that sonolysis (continuous transcranial doppler sonography using a 2-mhz diagnostic probe) can reduce the risk of new cerebral ischemic lesions during carotid endarterectomy and carotid angioplasty / stenting (skoloudik et al., 2015). currently, it is unknown whether sonolysis can also reduce the risk of new cerebral ischemic lesions during mitraclip implantation - a percutaneous treatment option in patients with moderate / severe mitral regurgitation. in this study, patients will receive cerebral mri and clinical neurological / neuropsychological examination before and after mitraclip implantation. during mitraclip implantation, all patients will receive continuous transcranial doppler sonography using a 2-mhz diagnostic probe with maximal diagnostic energy administered through either the left or the right transtemporal window (computer-generated 1:1 randomization). the primary endpoint is the median ischemic lesion volume detected on diffusion-weighted mri after mitraclip implantation in the sonolysis group and in the control group.

Eligibility criteria:
inclusion criteria: patients with mitral regurgitation that are assigned to the mitraclip implantation by an interdisciplinary heart team according to current guidelines. exclusion criteria: * contraindication to mri examination (e.g. pace-maker, implanted metal material, claustrophobia) * pregnancy * unable to consent * no transtemporal window

Keywords: mitraclip sonolysis stroke