Kornimate/medical-research-clean huggingface dataset:
hand-held optical coherence tomography feasibility older hip fracture

Conditions: Retinal Imaging

Summary: assessment of the feasibility of achieving retinal imaging in older people with recent hips fracture surgery using hand held optical coherence tomography device

optical coherent tomography (oct) is a device used to achieve cross-sectional imaging of tissues. it is often used in ophthalmology and also has application in dermatology, cardiology and other specialities. usually, in adults, a table-top device is used necessitating the transfer of patients to the location of the device. in children a hand held device is used meaning the device can be taken to the patients' location. to facilitate/ help design a future study, this study's aim is to assess the feasibility of achieving retinal imaging in older people who are recovering from hip fracture surgery using a hand held device.

Eligibility criteria:
inclusion criteria: * recent hip fracture surgery * age \> 64 years * no cognitive impairment * able to understand instructions given in english * consent exclusion criteria: * presence of degenerative eye disease e.g. age-related macula degeneration, glaucoma, diabetic retinopathy, hypertensive retinopathy * dementia, mild cognitive impairment, parkinson,s disease, multiple sclerosis, current delirium

Keywords: older hip fracture surgery optical coherence tomography
a study of lyrica as treatment for sleep problems in patients with sleep problems and seizures

Conditions: Sleep Deprivation; Epilepsies, Partial

Summary: the purpose of this study is to determine the effects of pregabalin on sleep problems in patients with seizures.


Eligibility criteria:
inclusion criteria: * partial epileptic seizures * not taking more than 1 background antiepileptic drug at study entry * disturbed sleep exclusion criteria: * more than 1 secondarily generalized tonic/clonic seizure per week on average over the previous 3 months * medical, psychological, or social conditions that could interfere with normal sleep
acustocerebrography (acg) in severe brain injury

Conditions: Brain Injuries, Acute

Summary: the study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in icu patients. for this, the acg diagnostic system (sonovum ag, leipzig, germany) should be used as additional diagnostic tool in prospective single-center study.

a multiple-step procedure, including repetition of the clinical examinations after a waiting period and use of additional technical diagnostic tools e.g. magnetic resonance tomography and transcranial doppler sonography (tcd) are needed for determining of severe brain injury and irreversible brain function failure. this study will enable the clinical applicability of the multiple-spectral-sonography for detection of severe brain injury in icu patients. for this, the acg diagnostic system (sonovum ag, leipzig, germany) should be used as additional diagnostic tool in prospective single-center study. the acg-method is a bedside non-invasive sonography that has been shown to be useful in previous studies analyzing circulatory changes in rat cerebral blood vessels, for example, to distinguish between brain-ischemia and -hemorrhage. additionally, in the case of brain death, the spontaneous electrical activity, which can be measured by means of acg as global elasticity, was not longer detectable. in the study should include 30 adult icu-patients in patients suspect to severe brain injury. the inclusion of patients will be started if written informed consent was obtained from participants or their representatives. after the inclusion, the acg is measured three times a day. in addition, the routinely practice (treatment and diagnostic) for patients with severe brain injury (neurological clinical examinations, use of additional technical diagnostic tools e.g. magnetic resonance tomography and transcranial doppler sonography (tcd); standard medical care) should be made and documented. from all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, illness severity scores (apache-ii, sofa, gcs), drug levels, microbiological results and cranial mri/ct results will be recorded.

Eligibility criteria:
inclusion criteria: * suspected severe brain injury exclusion criteria: * open skull brain trauma * skull fractures in the temporal area * decompression-craniotomy

Keywords: brain damage sonography
a study to evaluate fasting/postprandial serum apolipoprotein b-48 (apob-48) levels in diabetic participants with normal to moderately high low density lipoprotein-c (ldl-c) levels (mk-0653a-259 am1)

Conditions: Dyslipidemia; Hypercholesterolemia

Summary: this study will evaluate whether fasting/postprandial serum apob-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum ldl-c levels, and whether apob-48 levels can be used, along with ldl-c levels, to identify potential cardiovascular disease risk.


Eligibility criteria:
inclusion criteria: * participant has an ldl-c ranging from ≥100 mg/dl to \<160 mg/dl. * patient has a triglyceride (tg) level of ≤500 mg/dl. exclusion criteria: * participant treated with a lipid-lowering agent in the 6 weeks prior to visit 1 (screening period). * participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal \[uln\]) * participant has increased creatine kinase (ck) (≥2 x uln). * participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus. * participant has a history of alcohol and/or drug abuse.
primary vitrectomy with endolaser or encircling band for rhegmatogenous retinal detachment

Conditions: Rhegmatogenous Retinal Detachment; Primary Vitrectomy; Encircling Band; Endolaser Treatment

Summary: comparing primary ppv with 360° endolaser photocoagulation with primary ppv with an encircling band for patients with rrds.

published

Eligibility criteria:
inclusion criteria: * primary rhegmatogenous retinal detachment with or without macula-off detachment phakic or pseudophakic eyes * multiple breaks, inferior and posterior located breaks or unclear hole formation * proliferative vitreoretinopathy (pvr) stage a and b exclusion criteria: * previous retinal detachment surgery * giant tears * pvr stage c * age less than 18 years

Keywords: rhegmatogenous retinal detachment primary vitrectomy encircling band endolaser treatment
a trial to investigate pharmacokinetics, pharmacodynamics, safety and tolerability of biochaperone® pramlintide insulin in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: this is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.

this is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus. each subject will be randomly allocated to a sequence of three treatments:(i) simultaneous administrations of biochaperone® pramlintide human insulin (bc pram ins) and placebo, (ii) simultaneous injections of pramlintide (symlin®) and human insulin (humulin®) and (iii) simultaneous injections of insulin lispro (humalog®) and placebo. subjects will come in a fasted state to the clinical trial centre in the morning, meal test procedures will be performed and subjects will stay at the clinical trial centre until the post-dose follow-up period has been terminated.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18-64 years (both inclusive) * type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months * treated with multiple daily insulin injections ≥ 12 months * treated with an evening dose of once-daily insulin glargine u100 at screening * fasting c-peptide ≤ 0.30 nmol/l exclusion criteria: * known or suspected hypersensitivity to imps, paracetamol (acetaminophen) or related products * type 2 diabetes mellitus * clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator considering the underlying disease * presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator * known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption * intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening
pain related to head and neck cancer (hnc); implementation and evaluation of self-care measure due to the same illness

Conditions: Pain; Head and Neck Cancer

Summary: the purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer.

the purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer

Eligibility criteria:
inclusion criteria: all hnc patients who went through rt and were referred to the pain and rehabilitation centre at the university hospital (linköping, sweden) were invited to participate in the study which run from january 2015 - march 2017. - exclusion criteria: non swedish speaking individuals, severe social and/or psychological disorders, severe cognitive conditions,other serious medical conditions. -

Keywords: pain head and neck cancer depression anxiety health catastrophizing
pharmacokinetics of sirolimus and tacrolimus in liver transplant recipients with tacrolimus toxicity

Conditions: Hypertension

Summary: pharmacokinetics of tacrolimus and sirolimus alone and in combination in liver transplant recipients.

liver transplant patients receiving tacrolimus, and who experience side effects such as hypertension and renal dysfunction, will be converted to sirolimus with low-dose tacrolimus, or tacrolimus withdrawal. this study will evaluate allograft function by serial clinical lab testing, the pharmacokinetics of sirolimus and tacrolimus, the glomerular filtration rate (gfr) and the potential side effect of sirolimus, such as marrow suppression and hyperlipidemia. two pharmacokinetic evaluations are planned: once around the third post-transplant month and another one at about 12 months. expected outcomes are, a better understanding of sirolimus pharmacokinetic parameters over time in pediatric/adult liver recipients and early efficacy and safety data of the sirolimus as a non-nephrotoxic alternative to tacrolimus.

Eligibility criteria:
inclusion criteria: * recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old. * rejection-free post-transplant course for at least 3 months * renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance) * hypertension requiring anti-hypertensive mediations. * informed consent. * weight ≥15 kg. exclusion criteria: * rejection or infections within 3 months of enrollment. * intent to continue tac * active participation in ongoing studies of immunosuppressive agents. * lack of informed consent. * pregnant or breast feeding * hiv positive
epidemiological study of fabry disease screening in chronic kidney disease patients

Conditions: Fabry Disease

Summary: fabry disease is a rare x-linked lysosomal storage disorder caused by deficient activity of the enzyme α-gal a resulting from mutations affecting the gla gene. it is characterized by severe multi-systemic involvement that leads to major organ failure and premature death in affected men and in some women. the α-gal a deficiency results in progressive accumulation of un-degraded glycosphingolipids, predominantly globotriaosylceramide (gb3), within cell lysosomes throughout the body. in patients at the second or third decade, progressive proteinuria, decline in glomerular filtration rate (gfr), and tubular damage occur usually, and renal failure develops in the fourth decade. life-threatening renal, cardiac, and cerebrovascular diseases are added in later decades. in addition to that, fabry disease patient will eventually face end-stage renal disease (esrd) which was the most common cause of death in fabry patients before the development of dialysis and renal transplantation. thus it is critical to identify fabry patient as early as possible, before reaching the stage of esrd. additionally, early intervention of enzyme replacement therapy for fabry disease patient which will help the patient to preserve a better renal function and benefit from treatment outcome. apart from that today there is only one study published from turkey for fabry disease screening in ckd patient where they have screened 1453 and found that the overall prevalence of fabry disease in ckd patient was found to be 0.2% , 3/1453 (in which 0.4% in 656 male, 0.0% in 783 female). however, there was no information available within the asia region thereby a very low fabry disease awareness and diagnostic awareness among nephrologist in taiwan. therefore in the present study the investigators are aiming to investigate the prevalence of fabry disease in the ckd population (ckd stage 1 \~ 5) by conducting the first and largest high risk screening prevalence study among 2,000 ckd patients over 3 years in taiwan and the investigators hope by doing such a pilot study our data would contribute to a new paradigm of fabry disease diagnosis in the asia region.


Eligibility criteria:
inclusion criteria: * patient age ≥ 18 y/o (no age limit due to cardiac variant fabry ivs4 in taiwan symptom of onset could be beyond 60 y/o) * patient with confirmed chronic kidney disease (ckd 1\~5) diagnosis whose urine protein/creatinine (upcr) is 150mg/g or above, or urine albumin/creatinine (acr) is 30mg/g or above. * patient who are willing to sign inform consent form exclusion criteria: * patient who are unwilling to sign inform consent form * patient who received confirmed diagnosis of fabry disease * patient with known etiology of renal failure diagnosed with renal biopsy.

Keywords: high risk screening chronic kidney disease
aortic dissection detection risk score plus d-dimer in suspected acute aortic dissection

Conditions: Aortic Dissection

Summary: acute aortic dissection (ad) is a deadly, difficult to diagnose disease presenting with an array of common and unspecific symptoms. aortic dissection detection (add) risk score is a bedside clinical tool to estimate the risk of ad. d-dimer has been evaluated in several studies as a biomarker of ad and has showed a pooled diagnostic sensitivity of 97%. however, considering the severe morbidity and mortality of ad, a negative d-dimer per se is considered insufficient to rule-out ad in unselected patients. the aim of the present study is to evaluate whether the diagnostic performance of d-dimer differs in patients at different clinical risk of ad, and in particular whether a negative d-dimer test may allow safe rule-out of ad in any patient subgroup without necessity to perform urgent aortic imaging. consecutive adult patients with suspected ad presenting to emergency department will be enrolled before the establishment of a final diagnosis; a standardized clinical form comprehensive of presence/absence of 12 risk markers allowing add risk score fulfilled and d-dimer levels measured at presentation. the aortic imaging exam used to confirm or refuse of ad will be computed tomography angiography or transesophageal echocardiography and final diagnosis established after reviewing of all available data. the accuracy, failure rate and efficiency of a diagnostic strategy combining standardized clinical stratification via the add risk score with d-dimer testing will therefore be assessed.

acute ad will include the following etiological entities, also known as acute aortic syndromes: acute aortic dissection, intramural aortic hematoma, penetrating aortic ulcer and spontaneous aortic rupture. a pre-specified secondary sub-analysis will evaluate the diagnostic accuracy of focus cardiac ultrasound (focus) and chest x ray for suspected ad.

Eligibility criteria:
inclusion criteria: * age \>18 years * presentation to the ed with any of the following symptoms: chest pain, back pain, abdominal pain, syncope or symptoms of perfusion deficit (central nervous system, mesenteric, myocardial, or limb ischemia) * aortic dissection considered among the differential diagnosis by the attending physician. enrollment in the study will be decided by the attending physician during evaluation in the ed and before the establishment of a final diagnosis. exclusion criteria: * an alternative diagnosis to ad objectively established by the attending physician after the initial medical evaluation * clinical severity or other conditions not allowing complete evaluation/proper enrollment * lack of consent to participate to the study

Keywords: aortic dissection diagnosis emergency medicine d-dimer
effect of dexamethasone on post-spinal hypotension

Conditions: Post Spinal Anaesthesia Hypotension; Geriatric Population; Orthopedic Surgeries

Summary: the goal of this clinical trial is to learn if intravenous dexamethasone is effective for prevention of post spinal hypotension in geriatric population undergoing orthopedic surgeries. the main question aim to answer is: does intravenous dexamethasone in participants undergoing orthopedic procedures of lower limb under spinal anesthesia prevents post spinal hypotension? researchers are comparing two groups of participants * participants in (dexamethasone group) group d are receiving intravenous dexamethasone 8mg preoperatively * participants in (placebo group) group p are receiving placebo preoperatively.


Eligibility criteria:
inclusion criteria: patient undergoing orthopedic surgery in spinal anesthesia. asa ≤ 2. exclusion criteria: patients with history of cardiac arrhythmias. patients with history of acute coronary syndrome. patient with history of polytrauma. patients with contraindication to sa (e.g., coagulopathy, thrombocytopenia, allergy to local anesthetic agent) and those on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor) will be excluded.
study evaluating multiple doses of atn-103 in subjects with active rheumatoid arthritis

Conditions: Active Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety and efficacy of atn-103 when administered to subjects with active rheumatoid arthritis compared with placebo. all subjects must be on a stable dose and route of methotrexate.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly). exclusion criteria: * any significant health problem other than rheumatoid arthritis * any clinically significant laboratory abnormalities * any prior use of b cell-depleting therapy
impact of virtual reality on anxiety in patients undergoing interventional procedures

Conditions: Anxiety

Summary: periprocedural anxiety is a common problem for patients who undergo interventional pain procedures. virtual reality (vr) is an immersive experience that has gained acceptance in the medical field as a tool for reducing anxiety and pain for patients.research aim: to evaluate the effect of immersive virtual reality (vr) on periprocedural anxiety related to therapeutic cervical epidural steroid injections (esi). the investigators hypothesize that immersive virtual reality will result in a clinically meaningful anxiety reduction, defined as the proportion of participants with \> 50% reduction in numeric rating scale (nrs) anxiety scores when compared to participants in the non-treatment group who will have standard preprocedural waiting time conditions in clinic, but no vr experience. similarly, the investigators hypothesize a significant reduction in objective sympathetic tone as measured by skin sympathetic nerve activity (skna).


Eligibility criteria:
inclusion criteria: * age 18-80 years old at day of enrollment * neck pain patient deemed to be a candidate for pain control treatment with interventional fluoroscopically guided cervical epidural steroid injection as determined by their pain medicine provider based on history, physical exam, and radiographic findings * willingness to undergo pre-procedural intervention of vr viewing experience or equivalent pre-procedural wait time * no history of prior epidural steroid injections * did not receive sedatives prior to or during procedure exclusion criteria: * refusal / inability to participate or provide consent * contraindications to injection (anticoagulated states, allergy to components of injection, local infection at injection site, current infectious process or treatment of antibiotics for current infection) * uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder * history of alzheimer's, dementia, or cognitive dysfunction * patient currently taking benzodiazepines * severe motion sickness * seizure disorder * vision loss * non-english speaking patients

Keywords: anxiety pain procedures virtual reality
stem cell related donor safety study

Conditions: Related Hematopoietic Stem Cell Donors

Summary: the study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unrelated hematopoietic stem cell donors. the study will also assess the hypothesis that young (\ 60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations. an ancillary study of the psychological impact of donation on health-related quality of life (hrqol) will enroll related donors and compare them to an age-matched normative cohort.


Eligibility criteria:
inclusion criteria: * donors of any age providing either a first or second bm or pbsc donation * meet donation criteria per institution policies and procedures * willing to receive phone follow-up at 1, 6, and 12 months * signed informed consent for study participation for the hrqol ancillary study, inclusion criteria: * related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria * donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the hrqol proxy interview * english speaking * access to a telephone * willing to participate in pre-donation, 1 month and 1 year follow-up interviews * signed informed consent for study participation in ancillary study exclusion criteria: * per institutional guidelines * donors providing unstimulated peripheral blood stem cells or lymphocytes for the hrqol ancillary study, exclusion criteria: * children less than or equal to 4 years of age