Kornimate/medical-research-clean huggingface dataset:
knee stiffness in fibrosis diathesis

Conditions: Knee Replacement Arthroplasty; Fibrosis; Dupuytren's Disease

Summary: at the standard follow-up moment one year after primary tka for gonarthrosis, all patients will be checked for signs of fibrosis diathesis. this will be done by examining their hands for dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of dupuytren's contracture. these include family history, bilateral dd, and ectopic lesions, age of onset less than 50 years, male gender, ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis. this way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis. for both groups, the range of motion (rom) of the operated knee at 3 and 6 months will be retrieved in the charts, the rom at 12 months will be measured at that time. also, additional procedures performed to increase rom postoperatively will be retrieved from the charts (e.g. continuous passive motion, mobilization under anesthesia). other causes for knee stiffness will have to be recorded, since these will be the most important exclusion criteria. in the patients with clear signs of finger contractures, any impression of increase of contracture over the past 12 months will be recorded.


Eligibility criteria:
inclusion criteria: * all patients undergoing a total knee replacement for primary gonarthrosis with a minimum follow-up of 1 year exclusion criteria: * patients undergoing a tka for other reasons than primary gonarthrosis, e.g. after infection, posttraumatic arthritis,hemophilia,... * patients who had other problems after their tka resulting in knee stiffness, e.g. infection, bleeding,...
cardiac effects in long-term survivors of hodgkin's and non-hodgkin's lymphoma

Conditions: Hodgkin Disease; Lymphoma, Non-Hodgkin

Summary: this study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for hodgkin's and non-hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy.


Eligibility criteria:
inclusion criteria: * all patients with hodgkin's lymphoma and non hodgkin's lymphoma who underwent radiation therapy (rt) to either a mantle or modified mantle field with or without adriamycin at the wilmot cancer center at the university of rochester are eligible for the study. exclusion criteria: * any severe preexisting cardiac disease (e.g., arrhythmia, angina, coronary disease, myocardial infarction, or congestive heart failure) prior to diagnosis
the assessment of molecular breast imaging (mbi) in distinguishing benign from malignant breast disease

Conditions: Breast Abnormalities

Summary: the primary hypothesis of this project is that using molecular breast imaging (mbi) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy exclusion criteria: * known contraindication to mammographic imaging * women who are pregnant * women who are lactating * women who have significant existing breast trauma * women who have breast implants * women under 18 years of age. * women who had previous benign breast surgery within 1 year * males and children * women who are unable to understand or execute written informed consent * women who refuse to have a biopsy * women with any known renal disease - if an mri is deemed necessary, a serum creatine will be checked prior to injection of contrast. using the national kidney foundation recommendations, a glomerular filtration rate (gfr) greater than 60 may safely receive intravenous gadolinium-based mri contrast. those individuals with a gfr \>30 and \<60 can receive the contrast but at a reduced dose (typically half). those with a gfr \<30 will not receive mri contrast and will not undergo the exam. breast mri must be done with contrast if evaluating for cancer. several factors can affect the gfr such as age, body size, creatinine, renal status and will be calculated from the blood drawn. gfr is the final determinant and a creatinine greater than 1.6 usually has a gfr that precludes a breast mri with contrast. the final determinant will be the gfr.

Keywords: molecular breast imaging breast disease breast biopsy
urinary kim-1 after vancomycin or linezolid administration

Conditions: Acute Kidney Injury

Summary: acute renal injury is a common complication of critical illness. drug induced renal insult compounds the degree of injury in many patients, and a great deal of research has focused on prevention of this complication. traditional biomarkers of renal injury like serum creatinine and blood urea nitrogen content fail to consistently predict harm among patients at risk. kidney injury molecule 1 (kim-1) will be studied as a biomarker of renal injury.

see above

Eligibility criteria:
inclusion criteria: * eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours. * eligible patients are already prescribed intravenous vancomycin or linezolid per their primary care providers as a standard of care and dosed in manner that is consistent with current institutional practices. receipt of these antibiotics is not investigational. exclusion criteria: * exclusion criteria will include patients who have stage 3or greater chronic kidney disease or who have acute kidney injury prior to the start of intravenous vancomycin therapy, patients that only receive one dose of iv vancomycin or linezolid in total, as well as patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (bmi ≥ 40 kg/m2). * additionally, patients will be excluded if they are to receive more than 1 concurrent nephrotoxic medication within the prior 72 hours, have received intravenous contrast within 120 hours before randomization, exhibit baseline hematuria, or baseline proteinuria. * a list of concurrent nephrotoxins that would exclude patients from the study is provided in appendix c. * age range: ≥18 years of age, if age \> 90 will report as \> 90 years
understanding medication adherence among hiv patients

Conditions: Patient Commitment Preferences for Medication Adherence

Summary: in anticipation of a pilot study incorporating behavioral economics into the treatment of infectious diseases, we will conduct a survey with hiv/aids patients at the ponce clinic (infectious disease program of grady memorial hospital, emory university school of medicine, atlanta, ga).

we are planning a study to improve health outcomes among patients with hiv/aids using insights from behavioral economics and financial incentives. we will conduct a survey with hiv/aids patients at ponce clinic (infectious disease program of grady memorial hospital, emory university school of medicine, atlanta, ga). the patients will be low-income persons living with hiv/aids and possessing varying degrees of medication adherence. we want to better understand how this particular population would react to commitment devices designed to increase medication adherence. we will survey participants to see if they would prefer more commitment, in the form of a "take-medication-get-paid" plan; less commitment, in the form of an "attend-clinic-get-paid" plan; or if they would prefer to designate their own levels of commitment.

Eligibility criteria:
inclusion criteria: \* hiv/aids patients currently receiving treatment at the ponce clinic at the infectious disease program of grady memorial hospital (emory university school of medicine).

Keywords: hiv aids medication adherence commitment devices behavioral economics
a study of fostamatinib in subjects with impaired kidney function

Conditions: Rheumatoid Arthritis; Renal Impairment

Summary: a 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. stage 1 will include healthy subjects and subjects with end stage renal disease, while stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of stage 1. the study will also evaluate safety and tolerability in subjects with renal impairment.


Eligibility criteria:
inclusion criteria: * males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (bmi) between 18 and 40 kg/m2, inclusive * stable renal impairment with following creatinine clearance (clcr): stage 1 - end stage renal disease (esrd) \< 15 ml/min (requiring dialysis); stage 2 - mild renal impairment ≥ 50 to \< 80 ml/min; moderate renal impairment ≥ 30 to \<50 ml/min; and severe renal impairment 15 to \< 30 ml/min * healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance \>80 ml/min" * negative screen for human immunodeficiency virus and negative results for serum hepatitis b surface antigen and hepatitis c antibody exclusion criteria: * subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration * absolute neutrophil count less than 1600/mm3 or 1.6 x 109 l. * healthy subjects only: subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration * subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib * in the opinion of the investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding

Keywords: phase 1 healthy volunteers volunteers with renal impairment pharmacokinetics rheumatoid arthritis ra fostamatinib patients
auricular vns following intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: this study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.

vagal nerve stimulation (vns) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. the purpose of the proposed study is to determine if transcutaneous auricular vns will impact inflammatory markers in the blood and cerebrospinal fluid (csf) in patients with intracerebral hemorrhage, and how it impacts their clinical course and outcomes. this study will involve randomizing patients to stimulation with vns, or sham stimulation. blood and csf will be collected on admission, and serially throughout the patient's admission. clinical events tracked during the hospital stay include the development of peri-hematomal edema, interventions for edema (medical or surgical), and intensive care unit and hospital stay. outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge. no additional appointments will be made specially for the research study.

Eligibility criteria:
inclusion criteria: * adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ich) to barnes jewish hospital exclusion criteria: * patients \< 18 years old * patients with a presumed traumatic etiology for their ich, infratentorial location, ich volume \> 60 ml or \< 10 ml, at risk of imminent death (e.g. glasgow coma scale, gcs of 3 or one or more pupils unreactive), surgical intervention imminently planned (not including ventriculostomy) * patients undergoing active cancer therapy * patients with sustained bradycardia on arrival with a heart rate \< 50 beats per minute. * patients who cannot be enrolled within 48 hours of the initial bleed.

Keywords: vagal nerve stimulation pathologic processes intracerebral hemmorrhage cerebrovascular disorders brain diseases central nervous system diseases nervous system diseases vascular diseases hemorrhage
treatment of a pda with acetaminophen in preterm neonates: exploring various indications

Conditions: Patent Ductus Arteriosus

Summary: this study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (pda) is of concern. we will perform two simultaneous prospective observational studies over a 3 year period. the first will be of infants with clinically significant pdas beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a pda closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our nicu, contraindication due to medical status.


Eligibility criteria:
inclusion criteria: * infants born at 23 0/7 to 29 6/7 weeks gestation, with pda determined by medical team to need treatment and infant is beyond 14 days of life. exclusion criteria: * congenital heart disease pneumonia pulmonary hypertension pulmonary hemorrhage alt and ast ≥ 2x the upper limit of normal (=ast\> 150 u/l, alt\>90 u/l) sepsis/meningitis abnormal chromosomes hydrops major congenital malformations
alpha-lipoic acid reduces left ventricular mass in normotensive type 2 diabetic patients with coronary artery disease

Conditions: Type 2 Diabetes; Coronary Artery Disease; Left Ventricular Mass

Summary: cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (cad). most of the attention in treating cad in type 2 diabetes is understandably directed toward treating coronary artery conditions. however there are other treatable culprits in these patients. left ventricular hypertrophy (lvh) is widespread in type 2 diabetic patients with cad, even in the absence of hypertension. it is a strong predictor of cardiovascular events and all-cause mortality. regression of lvh has been associated with an improved prognosis, independent of change in blood pressure (bp). therefore, cardiovascular events and mortality in type 2 diabetes with cad might will be reduced if the investigators can find novel therapies to regress lvh. alpha-lipoic acid reduces oxidative stress which then regresses lvh. alpha-lipoic acid can improve endothelial function in diabetic conditions. hence, the main aim of this study was to assess whether alpha-lipoic acid could regress lvm in type 2 diabetic patients with cad.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * cad * left ventricular hypertrophy * hba1c below 7.0% * blood pressure \<130/80 mmhg exclusion criteria: * patients were excluded if they were currently alpha-lipoic acid for one year, had a previous adverse reaction to alpha-lipoic acid. * hey were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent. * patients with contraindications to cardiac magnetic resonance (cmr) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women.
music for sleep after stroke

Conditions: Stroke; Cardiovascular Diseases; Brain Diseases; Vascular Diseases; Insomnia; Sleep Disorder; Sleep Disturbance

Summary: sleep difficulties are common following stroke yet effective evidence-based interventions for improving sleep in this population are lacking. a small number of studies have investigated the use of music listening as a way to improve sleep in adults with insomnia. this study aims to examine whether a mindful music-listening intervention can reduce subjective and objective insomnia symptoms and improve mood and fatigue post-stroke. six adults with a clinical diagnosis of stroke presenting with an insomnia disorder will be recruited from stroke services within nhs greater glasgow and clyde. a multiple baseline single case experimental design will be employed. participants will be randomly allocated to a baseline phase of 7, 11 or 15 days, followed by a five-week mindful music-listening intervention incorporating sleep hygiene. changes in subjective and objective sleep will be measured using questionnaires and actigraphy, respectively. mood and fatigue will also be measured. the data will be analysed using visual inspection, tau-u and multi-level modelling.


Eligibility criteria:
inclusion criteria: * aged 18+ (no upper age limit); * clinically and/or radiologically confirmed diagnosis of stroke * score of ≤16 on the sleep condition indicator (sci; (espie et al, 2018)) * at least 3-months post-stroke exclusion criteria: * transient ischemic attack * subarachnoid hemorrhage * sleep medication commenced within the last 2 weeks (stable medication accepted) * significant receptive aphasia or major psychiatric/substance abuse problem preventing engagement in the intervention * deafness or severe hearing impairment preventing engagement in the intervention (use of hearing aids does not lead to exclusion where these support sufficient level of hearing for engagement) * unable to give informed consent. * participation in another intervention study with risk of contamination of study outcomes (determined on a case-by-case basis)
a study of ly3484356 in chinese participants with advanced breast cancer

Conditions: Breast Neoplasms

Summary: this is a study of ly3484356 in chinese participants with advanced breast cancer. participants must have breast cancer that is estrogen receptor positive (er+), her2 negative (her2-). the purpose of this study is to measure how much ly3484356 gets into the bloodstream and how long it takes the body to remove it. the safety and effectiveness of ly3484356 will also be studied. participation could last up to 28 months.


Eligibility criteria:
inclusion criteria: * native chinese participants must be of an acceptable age to provide informed consent * have locally advanced (not amenable to curative treatment by surgery) or metastatic disease and be an appropriate candidate for experimental therapy in the judgment of the investigator, after available standard therapies have ceased to provide clinical benefit * have a diagnosis of er+, her2- breast cancer * female participants have postmenopausal status due either surgical/natural menopause or ovarian suppression * if postmenopausal status is due to ovarian suppression, participants must have a negative serum pregnancy test and agree to use highly effective, medically approved precautions to prevent pregnancy * have a performance status less than or equal to (≤)1 on the eastern cooperative oncology group (ecog) scale * have adequate organ function * must be able to swallow capsules/tablets exclusion criteria: * have symptomatic central nervous system (cns) metastasis and/or carcinomatous meningitis * have a serious concomitant systemic disorder * human immunodeficiency virus (hiv) positive patients are excluded unless they are well controlled on highly active antiretroviral therapy with no evidence of autoimmune deficiency syndrome-defining opportunistic infections within the last 2 years, and cluster of differentiation 4 (cd4) count greater than (\>)350 cells/microliter (μl) * active hepatitis b or c virus infection * severe renal impairment, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, preexisting crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in clinically significant diarrhea * have visceral crisis * have a serious cardiac condition * have an acute leukemia or other relevant cancers * females who are pregnant or lactating * known allergic reaction against any of the components of the study drug
tolerability of slit with lais® 2-tree allergoid tablets

Conditions: Allergic Rhinitis

Summary: to expand knowledge on the application and tolerability of immunotherapy with lais® 2-tree allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice.

until now, results from controlled studies with their specific requirements (patient selection, defined inclusion and exclusion criteria, close patient management and monitoring, randomisation) are available for lais® 2-tree allergoid tablets only for a small patient population. in addition, an open-label, controlled study and an observational study have been carried out investigating the clinical efficacy and tolerability of the preparation. owing to the differences in the study designs, the allergen dose administered and the frequency with which the preparation was applied varied among the individual studies, making it necessary to gather further data on the safety and tolerability of the preparation in a larger patient population. the observation schedule of this nis (nis in accordance with article 67 paragraph 6 of the german medicinal products act (amg)), which takes into account the recommendations made by the german federal institute for drugs and medical devices (bfarm) and by the paul ehrlich institute for planning, implementing and evaluating an nis, is geared to the routine procedure carried out for patients with allergies to tree pollen. the aim of this observational study is to observe and document the tolerability and improvement of symptoms after treatment with lais® 2-tree allergoid tablets under normal application conditions and in consideration of the chosen titration schedule in therapeutic practice - in accordance with the patient information leaflet - in a large patient population: * retrospective survey of rhinitis/rhinoconjunctivitis symptoms induced by tree pollen * overall symptomatology * documentation of restrictions caused by allergy/asthma * tolerability of the treatment by means of ae documentation * patient compliance additional requirements extending beyond the specifications listed in the patient information leaflet on product use, patient groups, dosage, contraindications, etc., will not be made.

Eligibility criteria:
inclusion criteria: * patients aged 5 years or older having allergies within the scope of specifications stated in the patient information leaflet exclusion criteria: * contraindications according to the patient information leaflet

Keywords: non interventional study nis sublingual immunotherapy allergen tree birch alder