Kornimate/medical-research-clean huggingface dataset:
cardiovasculorenal phenotyping in fabry disease through noninvasive testing

Conditions: Fabry Disease

Summary: a longitudinal pilot study will be conducted to determine if there are additional testing modalities that are effective in broadly phenotyping subclinical dysfunction in patients with fabry disease. individual patients will undergo serial testing over a two-year period to evaluate for changes in their cardiovasculaorenal function during this period. novel modalities evaluated will include measures of arterial stiffness, ambulatory blood pressure monitoring, cardiopulmonary exercise testing (cpet), and novel serum and urine biomarkers. the benefit of these measures being evaluated is that they are noninvasive, can be performed rapidly, and have reduced costs compared to the current standard screening modalities. results from these evaluations will be compared to cmri and standard urine and serum biomarkers performed clinically per local standard of care. the results will also be compared to both published normative data and data from patients with diabetes mellitus, who have a similar microvascular disease process to patients with fabry disease.


Eligibility criteria:
inclusion criteria: * fabry patients with classical disease * english speaking, which is needed to assist with obtaining a maximal effort cpet * no medical contraindications to cardiopulmonary exercise testing or cmri * either treatment naïve or current taking ert exclusion criteria: * physical limitation that would preclude exercise * currently prescribed non-ert treatments for fabry disease
early treatment of recurrent hcv- infection post liver transplantation in the era of daas

Conditions: Liver Transplantation

Summary: the study aimed to present our experience in treating recurrent hcv genotype 4 infection post living donor liver transplantation (ldlt) since introduction of the second generation direct acting antiviral drugs (daas) in egypt.

this was a cohort study conducted in patients who had undergone ldlt for hcv related disease from 2014 to 2016 at in ain shams center for organ transplantation (ascot) .the hypothesis early initiation of daas( after 12 weeks of the operation ) is effective and safe strategy in transplant recipients following ldlt. patients who take the sofosbuvir and ribavirin after 6 months after transplantation were compared with those who take early treatment after 3 months of transplantation with sofosbuvir and daclatsvir+/- ribavirin..patients were on regular follow up visits monthly to assess the clinical condition, any side effects, laboratory tests including complete blood picture, liver functions , renal functions and trough level of immunosuppressant drugs.

Eligibility criteria:
inclusion criteria: * all transplanted patients for hcv related disease in the period from 2014 to 2016 exclusion criteria: * patients transplanted for other causes rather than hcv * patients with hbv and hcv co infection
effects of increasing mean arterial pressure on renal function in patients with shock and with elevated central venous pressure

Conditions: Shock

Summary: the purpose of this study is to assess the effect of a higher mean arterial pressure on renal function for patients with shock and elevated central venous pressure.

current recommandation for mean arterial pressure (map) target is 65 mmhg for septic shock, but optimal target to prevent acute renal failure (arf) remains unknown. high central venous pressure (cvp) can lead to acute renal failure through venous congestion , and is associated with acute renal failure in intensive care unit. a decrease of renal perfusion pressure, defined by map - cvp, has been shown to be associated with risk of acute renal failure. the main objective of this trial is to evaluate if an optimisation of renal perfusion pressure, by a higher map when cvp is high (≥ 12 cmh2o), can improve renal function. in this interventional monocenter trial, each patient will be evaluated during 2 consecutive periods of 6 hours, with a temporary map target * target at 65-70mmhg during 6 hours * target at 80-85mmhg during 6 hours patients will be randomized into two groups to define the order of targets. there will be a stratification on previous arterial hypertension. renal function will be measured at the end of each period.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old ) * arterial hypotension requiring the etablishment of catecholamines * norepinephrine dose ⩾ 0.1µg/kg/min at the inclusion * high central venous pressure ≥ 12mmhg * cardiac output monitoring (picco or swan ganz) exclusion criteria: * anuria * patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with ph \ 40 mmol/l) * pregnant, lactating or parturient woman * patient deprived of liberty by judicial or administrative decision * patient with psychiatric compulsory care * patient subject to legal protection measures * patients with do-no-reanimate order or withdrawal of life sustaining support

Keywords: mean arterial pressure central venous pressure renal function
histamine and bone pain association in participants with breast cancer metastatic in the bone

Conditions: Bone Pain; Breast Carcinoma Metastatic in the Bone

Summary: this trial studies histamine and bone pain association in participants with breast cancer that has spread to the bone. studying histamine levels in samples of blood from participants with breast cancer in the laboratory may help doctors learn more about reducing cancer bone pain and preventing further bone metastasis.

primary objectives: i. to correlate levels of histamine in plasma with pain scores in patients with bone metastases from breast cancer that have or have not been treated with palliative radiotherapy. secondary objectives: i. to perform exploratory studies with additional markers not mentioned, including calcitonin gene-related peptide (cgrp), stem cell factor (scf), angiotensin ii (ang ii) substance p, angiotensin 1-7 (ang1-7), may be performed at the investigator's discretion. ii. to perform next generation ribonucleic acid (rna) sequences using the whole blood to determine whether histamine system is involved in the development of cancer-induced bone pain (cibp). iii. to assess the impact of pain response after radiotherapy on bone structural properties such as bone mineral density and cortical thickness, and patient quality of life, physical and psychological function. outline: participants undergo collection of blood samples for histamine level analysis via enzyme-linked immunosorbent assay (elisa). after completion of study, participants are followed up at 1, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * breast cancer patients with radiographic evidence of bone metastases (by plain film, computed tomography \[ct\], magnetic resonance imaging \[mri\], positron emission tomography \[pet\] or bone scan) within 8 weeks of registration * weight bearing sites: pelvis (excluding pubis), femur, sacrum and/or sacroiliac joints, tibia, up to 5 consecutive cervical, thoracic or lumbar vertebral bodies, lumbosacral spine * non-weight bearing sites: up to 3 consecutive ribs, humerus, fibula, radius +/- ulna, clavicle, sternum, scapula, pubis * patients with and without pain related to the radiographically documented metastases are eligible for study * ability to understand and the willingness to sign an institutional review board (irb)-approved informed consent document exclusion criteria: * pregnant women will be excluded
pharmacokinetic interaction between azd3480 and donepezil

Conditions: Alzheimer's Disease

Summary: the aims of this study are to 1) examine the effects of azd3480 and donepezil on the blood concentrations of each other and 2) assess the safety and tolerability of the combined administration of azd3480 with donepezil.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study-specific procedures * bmi between 18 and 30 kg/m2 * medical and surgical history and physical examination without any clinically significant findings * genotyped as an em, defined in this study as having ≥ 1.5 functional cyp2d6 alleles, or a pm, defined as having zero functional cyp2d6 alleles exclusion criteria: * history of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the investigator * clinically significant illness as judged by the investigator, within two weeks before the first administration of investigational product * female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Keywords: healthy volunteers
beta 2 adrenergic stimulation vs cold exposure to activate human brown adipose tissue

Conditions: Thermogenesis

Summary: the purpose of the study is to asses brown adipose tissue activity in humans after intravenous administration of the selective beta-2-adrenergic agonist fenoterol as compared to the natural activator of brown adipose tissue, a mild cold stimulus.

the activation of brown adipose tissue in response to beta-2-adrenergic stimulation as compared to cold exposure will be studied in an open-label, cross-over trial in healthy volunteers with random sequence of the two study interventions a) and b): 1. a bolus of 25µg fenoterol will be slowly injected intravenously during 2-3 minutes followed by a continuous infusion of fenoterol 1µg/min over 120 minutes. the total dose of fenoterol per subject will thus be 145µg. 2. during 120 minutes participants will be exposed to a mild cold stimulus water using cooling sleeves, covering the participant's waist, is gradually decrease body surface temperature to 10 degrees or to the lowest tolerable temperature without shivering. energy expenditure will be measured during both interventions by indirect calorimetry and brown adipose tissue activity will determined by 18f-fdg-pet/ct 30 min after injection of 75 mbq of 18f-fdg.

Eligibility criteria:
inclusion criteria: * bmi 18,5-23 kg/m2 or 30-35 kg/m2 exclusion criteria: * history or signs of any medical or psychological condition * pregnancy or lactation * medications except prescription free analgesics and contraceptives * habitual alcohol or tobacco use * weight change \>5% within prior 3 months * resting heart rate \>85 bpm * systolic blood pressure \>140 mmhg or diastolic blood pressure \<50 mmhg * presence of following ecg changes: st-segment deviations, qtc \>500ms, signs of pre-excitation * hyper- or hypothyroidism * inability to follow study procedures * enrolment of the investigator, his/her family members, employees and other dependent persons * hypersensitivity to cold * enrolment into study with ionizing radiation within prior 12 months. * cold induced thermogenesis of less than 5% basal metabolic rate and normal weight or cold induced thermogenesis of more than 5% and overweight (determined during screening visit)

Keywords: brown adipose tissue beta2-adrenergic agonist cold exposure
the teachable moment: screening and brief intervention for admitted trauma patients

Conditions: Alcoholism

Summary: the american college of surgeons now requires screening for alcohol use in trauma centers. the purpose of this research study is to provide information about the best screening and treatment methods. the investigators hope the findings will provide information that will improve healthcare by reducing problems related to risky alcohol use. the trauma team is conducting a comparison of two different ways of talking about alcohol use. participants will be randomized into one of the two study groups.

the goal of this study is to guide further policy development regarding effective alcohol screening by: (a) comparing the effectiveness of two new, shorter screening tools for risky drinking patterns with the longer screening tool in current use; (b) assessing the outcomes of two different brief counseling interventions (bis) with trauma patients screened to have risky drinking behaviors; and (c) examining the impact of the implementation of this new policy in a level i trauma center. the specific aims will be accomplished by: 1. screening patients who are admitted to the trauma center, and conducting bis for all who screen positive; 2. collecting formative qualitative data regarding participants' perceptions of benefits of drunken states, their individual risks, and perceived healthier alternatives; 3. collecting quantitative data (injury severity score and hospital length of stay) and correlating these data with patient demographics and responses on the different screening methods; 4. collecting follow-up data by telephone on self-reported alcohol use and trauma recidivism, using an interviewer-administered assessment; 5. collecting data on trauma recidivism from ed data, publicly available records, and patient self-report at 6-month telephone follow-up; 6. surveying trauma staff and physicians at three intervals regarding the process of implementing the new acs policy, any perceived difficulties, and the perceived impact

Eligibility criteria:
inclusion criteria: * inpatient on trauma service * 18 years or older * speaks either english or spanish one or more of the following: * patient answered yes to either admission screening question * patient has a positive bal of less than or equal to 79 and also has a positive audit score (men greater than or equal to 8; women greater than or equal to 4) * patient has a bal of 80 or higher * patient has no record of a bal on file and they have a positive audit score exclusion criteria: * patient unable or unwilling to provide informed consent * patient refusal contact at six months * patient has a positive bal of less than or equal to 79 and negative audit score * patient deemed unable to complete a bi

Keywords: trauma alcohol brief intervention
comparison the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation in patients following craniotomy

Conditions: Neoplasms, Intracranial

Summary: this study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. patients were randomized into a control group (g-k, n:20), an is group (g-is, n:20) and a cpap (continuous positive airway pressure) group (g-cpap, n:20)

this study will compare the effectiveness of postoperative incentive spirometry and noninvasive mechanical ventilation on pulmonary functions after craniotomy in 60 patients. patients were randomized into a control group (g-k, n:20), an is group (g-is, n:20) and a cpap (continuous positive airway pressure) group (g-cpap, n:20). the investigators included male or female, between 18 and 60 years old, american society of anesthesiologists score 1, 2 patients in this study. the investigator excluded patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation from this study. in postoperatively, control group will take 4lt/min oxygen with plasti-med oxygen therapy mask for 6 hours, is group will carry out plasti-med triflo 5 min per hour for 6 hours, cpap group will carry out 10 cmh2o noninvasive continuous positive airway pressure with bipap vision 5 min per hour for 6 hours. lung functions and arterial blood gas analysis will be recorded preoperative baseline, postoperative 1st, 6th and 24th hours.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists score 1, 2 patients exclusion criteria: * patients with significant cardiopulmonary disease like myocardial infarction, obstructive or restrictive pulmonary disease, liver or kidney failure, chest wall deformities, postoperative lack of cooperation
prediction of bleeding risk after anticoagulant therapy for atrial fibrillation based on proteomics and metabolomics

Conditions: Atrial Fibrillation; Bleeding; Anticoagulant Therapy

Summary: objectives: atrial fibrillation (af) is the most common arrhythmia. anticoagulation with warfarin or new oral anticoagulants in patients with af can significantly reduce thromboembolic events. however, due to the lack of bleeding risk predictors of oral anticoagulants, the bleeding risk of patients with af cannot be accurately evaluated. the purpose of this study is to screen biomarkers that can predict bleeding in patients with af through proteomics and metabolomics, and construct the protein metabolic network pathway of anticoagulant bleeding in patients with af. design: af patients treated with oral anticoagulants were enrolled in this study. blood samples were centrifuged and the supernatant was stored in the refrigerator at - 80 ℃. all patients were followed up for one year to determine whether bleeding occurred after oral anticoagulants. proteomic data were obtained by lc-ms/ms analysis-dia platform. metabolomic data were obtained by uplc-qtof/ms platform. all of the omics data were used to compare proteins/enzymes with metabolic pathways. quantitative changes of individual metabolites and proteins were calculated and graphed using the kegg mapping tools.


Eligibility criteria:
inclusion criteria: 1. age 18 years or above 2. admission with atrial fibrillation or clinic visit for atrial fibrillation 3. receive routine anticoagulant therapy; 4. signing the consent form exclusion criteria: 1. pregnant women; 2. lactating women; 3. severe mitral stenosis; 4. severe impairment of liver function; 5. severe renal insufficiency; 6. thyroid dysfunction requiring treatment; 7. have a history of severe bleeding within five years, such as intracerebral hemorrhage and gastrointestinal bleeding.

Keywords: atrial fibrillation bleeding anticoagulant therapy
study to determine if avonex and rebif work comparably well in subjects with relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to find out if weekly avonex works as well as three times a week rebif in subjects with relapsing multiple sclerosis.

this is a phase 4, multicenter, prospective and retrospective, long-term observational study of avonex® and rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing ms.

Eligibility criteria:
inclusion criteria: * must have been receiving avonex® or rebif®. * must have a confirmed diagnosis of relapsing-remitting ms using the poser criteria. * must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment. * must have an edss score of 0.0 to 5.5, inclusive. exclusion criteria: * history of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation. * history of poorly controlled hypertension and/or other clinically significant major disease. * history of uncontrolled seizures within the 3 months prior to enrollment. * history of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment. * serious local infection or systemic infection within 8 weeks prior to enrollment. * treatment with certain other agents to treat ms symptoms or underlying disease. * treatment with any investigational product * previous participation in this study. * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple sclerosis interferon beta 1a avonex
role of mega dose of vitamin c in critical covid-19 patients

Conditions: Corona Virus Infection

Summary: vitamin c (ascorbic acid) is a water-soluble vitamin having anti-inflammatory, immunomodulatory, anti-oxidative, antithrombotic and antiviral properties. considering these effects vitamin c should have beneficial impact in patients suffering from sepsis and acute respiratory distress syndrome (ards). the current study is designed to assess the beneficial effects of vitamin c in covid-19 infected patients.


Eligibility criteria:
inclusion criteria: critically ill patients admitted in icu exclusion criteria: allergic to vitamin c didnt given the consent
a phase 2 study to explore the efficacy and safety of hb0017 longer dose interval in psoriasis patients

Conditions: Psoriasis (PsO)

Summary: this study is a randomized, double-blind phase 2 clinical trial aimed at exploring the efficacy, safety, and immunogenicity of hb0017 injection with different dosing regimens in the treatment of moderate to severe plaque psoriasis in subjects


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18-75 years (inclusive) * chronic plaque psoriasis (pso) for at least 6 months prior to the randomization. * psoriasis area severity index (pasi) \&gt;=12 and body surface area (bsa) affected by pso \&gt;=10% and static physician global assessment (spga) score \&gt;=3. * subjects who are suitable for systemic treatment or phototherapy for psoriasis as judged by the investigator * subjects who are able to use effective contraception from the screening period to 6 months after the last dose exclusion criteria: * forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline drug-induced psoriasis * ongoing use of prohibited treatments * any active infection (other than common cold) within 14 days * serious infection defined as requiring hospitalization or iv anti-infective(s) within 1 month prior to randomization * have previously received any drug that directly targets il-17 or il-17 receptor * have concurrent or recent use of any biologic agent within the following washout periods: etanercept \&lt;28 days; infliximab and adalimumab \&lt;60 days; golimumab \&lt; 90 days; anti-il-12/anti-il-23 or anti-il-23p19 antibody drugs \&lt;6 months; or other anti-psoriatic therapy not listed herein within its 5 half-lives prior to randomization * a history of inflammatory bowel disease or other serious autoimmune disease * previously diagnosed with serious mental illness such as anxiety, depression or suicidal tendency

Keywords: hb0017 psoriasis longer dose regimen