Kornimate/medical-research-clean huggingface dataset:
relationship between data obtained with the lugene® multiparameter transcriptomics blood test and clinical and standard laboratory features of patients with sle (relate)

Conditions: Lupus Erythematosus, Systemic

Summary: this is an open label study to determine the association of the data obtained with lugene®, a transcriptomic-based ldt, with standard evaluation of patients diagnosed with sle, including clinical involvement, sledai score, physician global assessment (pga) and standard laboratory measures, including ana, anti-dna, anti-rnp and complement components c3 and c4, as well as patient reported outcomes capturing pain, fatigue and health-related quality of life. the test will be administered on one occasion to patients with a clinical diagnosis of lupus or incomplete lupus and clinical and laboratory features evaluated contemporaneously. this trial includes a pilot study of approximately 10 subjects from 2-3 sites to assess whether the delivery times of lugene® laboratory results do not exceed more than 7 business days.


Eligibility criteria:
inclusion criteria: 1. male or female aged at least 18 years old. 2. capable of giving written consent on an irb-approved informed consent form prior to any study-specific evaluation 3. have a clinical diagnosis of sle determined by the examining physician or a diagnosis of incomplete lupus determined by the examining physician 4. on a stable sle treatment regimen consisting of a stable dosage of medications for a period of at least 30 days prior to testing exclusion criteria: 1. have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to sle (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patient at undue risk 2. have received intravenous glucocorticoids at a dosage of ≥ 500 mg daily within the past month 3. have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to baseline 4. pregnant or lactating. 5. recent participation in a clinical trial with an experimental agent in the past 6 weeks, or 5 half-lives of the study drug, whichever is longer 6. any condition that in the opinion of the treating physician might interfere with the performance of the lugene® test
a systematic study of retinal structure and function in diabetic macular oedema

Conditions: Diabetes Mellitus; Diabetic Retinopathy; Diabetic Macular Edema

Summary: diabetic retinopathy(dr) is a sight threatening condition that occurs in persons with diabetes. dr arises as a consequence of damage to the retinal blood vessels and is related to the high and fluctuating sugar levels in the blood stream. an eye with dr will have abnormal appearing retinal blood vessels which become engorged and dilated, leaky and fragile or undergo closure. the net result is a picture of haemorrhage and or ischaemia (lack of blood supply). a particular feature of dr is the accumulation of fluid in the macula which is the central part of the retina and responsible for detailed eye sight. this peculiar form of dr is called diabetic macular oedema (dmo). dmo can occur in isolation without other features of dr. dmo is commoner in type 2 diabetes where insulin resistance and abnormalities of blood fats are found. the investigators wish to study dr and dmo using high resolution retinal imaging and functional tests in normal participants, those participants with diabetes without any overt signs of disease and those with dr and dmo in order to understand how the condition develops and whether there are any unique risk factors that can be identified


Eligibility criteria:
inclusion criteria: group 1 (healthy controls without dm): * persons older than 18 years without dm * fundus free of any signs of retinal disease * best corrected visual acuity of 20/40 (73 etdrs letters) in both eyes group 2 (persons with dm with no retinopathy): * persons with type 1 or type 2 diabetes older than 18 years * normal fundus, absence of features of dr or dmo in both eyes * best corrected visual acuity 20/40 (73 etdrs letters) in at least one eye group 3: * persons with type 1 or type 2 diabetes 18 years and older * fundus signs of mild, moderate or severe dr and or dmo * best corrected visual acuity 20/200 (33 etdrs letters) or better exclusion criteria: * recent ocular surgical procedures performed within the previous 3 months * presence of ocular confounding disorders such as neovascular age related macular degeneration, glaucoma or active uveitis * serious life threatening conditions that would preclude attendance in the longitudinal part of the study * neurological conditions that can impair vision
cognitive fatigue, self-regulation, and academic performance: a physiological study

Conditions: Cognitive Fatigue; Mental Fatigue; Behavioral Performance; Heart Rate Variability; Skin Conductance; Academic Performance; Self-regulation

Summary: this study aims to examine the relationship among cognitive fatigue, self-regulation, and academic performance.

1) sievertsen et al. (2016) have demonstrated that standardised test performance decreased with every hour later in the day and increased after a break. hence, we hypothesise that standardised test performance would vary as a function of physiological response during cognitive fatigue. 2) martin et al. (2019) found that those who participate in more self-regulatory activity were less susceptible to the effects of cognitive fatigue. hence, we hypothesise that greater self-regulation may moderate the relationship between cognitive fatigue and standardised test performance. individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, sleep quality, depression, anxiety, stress, baseline physiology and behavioural performance) will be examined and accounted for.

Eligibility criteria:
inclusion criteria: * singapore-based * non-clinical * 18-35years exclusion criteria: * individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing * individuals with a history of ear, developmental, neurological, or psychiatric disorder
alternative options to minimize niacin-induced flushing

Conditions: Hypercholesterolemia; Flushing

Summary: niacin (vitamin b3) is known to effectively and safely treat hypercholesterolemia. however, use of niacin is limited due to incidents of flushing which limits its acceptability. some information suggests that applesauce can reduce the incidence and severity of flushing. the apple pectin in particular is thought to be the ingredient that affects this reaction. to determine if the apple pectin does affect flushing from niacin, the investigators will study the affects of isolated apple pectin in pill form. the investigators plan on recruiting 100 patients, and giving them 1000 mg of niacin to induce flushing. patients will be divided into 4 treatment groups and receive either pectin, aspirin, a combination of both, or placebo. incidents and severity of flushing will be monitored for up to 6 hours post niacin ingestion.


Eligibility criteria:
inclusion criteria: * an adult between 21 and 70 years of age. * male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception). * able to speak and read english. * willing to comply with study specific instructions, and complete all study procedures according to protocol. * able to understand study rationale and sign informed consent. exclusion criteria: * females of child-bearing potential not using acceptable method of contraception and perimenopausal females. * history of gout * history of diabetes mellitus * history of coronary heart disease * history of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure. * history of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease * known sensitivity to niacin, aspirin or nonsteroidal anti-inflammatory agents (nsaids) * history of migraine or cluster headaches * currently using antihistamines, aspirin or nsaids on a consistent basis * presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation. * lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation. * currently taking medication that might be contraindicated with the study drug or niacin or study procedures (including niacin, lipid-lowering drugs, chronic aspirin or laxative use). * clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.

Keywords: niacin hypercholesterolemia flushing
effect of virtual reality technology for managment of acute pain in outpatient hysteroscopy

Conditions: Acute Pain; Anxiety

Summary: performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. virtual reality (vr), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. it is a computer-generated representation of an immersive videos viewed through a headset.

performing out patient diagnostic and operative gynecological procedures is becoming more popular having the benefits of reducing risks of general anaesthetia, decreasing healthcare burden and increasing satisfaction for both patient and provider. such procedures are usually well tolerated , however it can be associated with acute pain and anxiety. options of pain relief include sedation, local anaesthetic , analgesics and distraction techniques, however no consistent good quality evidence exists to support practice. virtual reality (vr), a new technology, has been studied as a distraction technique for non-pharmacological method of pain relief. it is a computer-generated representation of an immersive videos viewed through a headset. the obstacles of cost, quality and accessibility of (vr) devices have significantly eliminated in recent years and offer promising application in the medical field. virtual reality for managing pain has been studied in many fields including paediatrics, dentistry, burns treatment, chronic pain, labour, and episiotomy. although a meta-analysis suggested that vr may have a role in reducing pain scores in acutely painful interventions , studies found it to be effective only in needles and burns physical therapy. the studies of vr on pain and anxiety, however, were limited by clinical and statistical heterogeneity. nonpharmacological options of pain relief have not explored enough the role of vr in reducing pain and improving patient experience in outpatient hysteroscopy .to our knowledge, there is only one publication studying the role of virtual reality in the management of acute pain during office gynaecological procedures

Eligibility criteria:
inclusion criteria: - patients scheduled for diagnostic hysteroscopy e.g. infertility, aub exclusion criteria: * absolute contraindication to office hysteroscopy such as acute pelvic infection , active genital herpes , heavy bleeding or pregnancy. * psychological ,hearing or visual disorders. * known anatomical condition that make performing office hysteroscopy is difficult such as cervical stenosis ,fibrosis or cervical amputation . * previous history of failed office hysteroscopy * patients scheduled for operative hysteroscopy.

Keywords: hysteroscopy acute pain anxiety virtual reality
dissemination of cervical cancer screening to primary care physicians in underserved communities

Conditions: Cervical Cancer

Summary: primary care physicians have an important role to play in the delivery of cancer prevention and detection services to patients. face-to-face counseling of physicians, called academic detailing, involves a brief and focused intervention, modeled on the practices of pharmaceutical companies. this type of intervention may increase physicians' attention to preventive opportunities and increase their screening behaviors.

the specific aims of this proposal are: 1. to test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician cervical cancer screening at 3- and 6-months post-randomization, compared to the rate observed in a service-as-usual control. 2. to develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of cervical cancer screening guidelines to different physician subgroups. 3. to conduct a cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the cervical cancer intervention implemented in physicians' offices. the long-term goal of this project therefore is to reduce cervical cancer risks among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.

Eligibility criteria:
inclusion criteria: * charts of female patients age 18-85 with at least one visit to the primary care provider over the last two years will be reviewed exclusion criteria: * exclusion criteria will include: diagnosis of cancer other than non-melanotic skin cancer and removal of the uterus.

Keywords: cervical cancer screening medically underserved women hpv vaccine
cardiac registry of celution device for the processing of adipose-derived regenerative cells

Conditions: Heart Failure; Coronary Artery Disease

Summary: this cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (adrcs) delivered via intramyocardial injection.


Eligibility criteria:
inclusion criteria: * males or females \> 20 and \< 80 years of age * significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization or idiopathic dilated cardiomyopathy * symptoms of heart failure (e.g. nyha stages of heart failure class ii or iii) * on maximal medical therapy for heart failure and if present, anginal symptoms * hemodynamic stability (sbp ≥ 90 mm/hg, hr \<110 beats/min) * ejection fraction ≤ 45% * left ventricular wall thickness \> 5 mm at the target site(s) for cell injection, confirmed by contrast echo within 4 weeks prior to enrollment, and free of thrombus exclusion criteria: * vascular anatomy and/or peripheral artery disease that prevents or impedes cardiac catheterization * aortic or mitral valve disease where valve replacement is indicated * presence of mechanical aortic or mitral valves * presence of aortic dissection * planned staged treatment of cad or other therapeutic intervention on the heart within the subsequent 3 months * tia or stroke within 30 days prior to the procedure * icd placement or ablation therapy within 30 days prior to the procedure * acute coronary syndrome (acs) or a myocardial infarction in the 30 days prior to the procedure * revascularization within 30 days prior to intramyocardial injection of adrcs * pregnant or lactating status. pregnancy as determined by a positive pregnancy test at screening or baseline.

Keywords: celution adrc heart failure device
ph ii of non-myeloablative allogeneic transplantation using tli & atg in patients w/ cutaneous t cell lymphoma

Conditions: Mycoses; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Bone Marrow Transplant Failure; Lymphoma, Non-Hodgkin; Cutaneous T-cell Lymphoma

Summary: non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (hsct) using a unique non-myeloablative preparative regimen, tli/atg, to treat advanced mycosis fungoides/sezary syndrome (mf/ss).

primary objectives -to evaluate the graft versus lymphoma effect by monitoring rate of clinical response, event-free and overall survival. secondary objectives -to evaluate the incidence and extent of acute and chronic graft-versus-host disease (gvhd) and time to engraftment.

Eligibility criteria:
inclusion criteria: 1. stage iib-iv mycosis fungoides or sezary syndrome, who have failed at least 1 standard systemic therapy or are not candidates for standard therapy. 2. pathology reviewed and the diagnosis confirmed at stanford university medical center. 3. age \> 18 years and \<= 75 years. 4. karnofsky performance status \>= 70%. 5. corrected dlco \>= 40% 6. left ventricle ejection fraction (lvef) \> 30%. 7. alt and ast must be \<= 3x normal. total bilirubin \<= 3 mg/dl unless hemolysis or gilbert's disease. 8. estimated creatinine clearance \>= 50 ml/min. 9. have a related or unrelated hla-identical donor or one antigen/allele mismatched in hla-a, b, c or drb1. 10. signed informed consent. 11. patients with prior malignancies diagnosed \> 5 years ago without evidence of disease are eligible. 12. patients with a prior malignancy treated \ 5 years for that malignancy are eligible. donor inclusion criteria 1. age \>=17. 2. hiv seronegative. 3. no contraindication to the administration of g-csf. 4. willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate exclusion criteria: 1. uncontrolled active infection. 2. uncontrolled congestive heart failure or angina. 3. pregnancy or nursing patients will be excluded from the study. 4. those who are hiv-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation. donor exclusion criteria 1. serious medical or psychological illness. 2. pregnant or lactating women are not eligible 3. prior malignancies within the last 5 years except for non-melanoma skin cancers
cognitive training and tdcs for children with fasd

Conditions: Fetal Alcohol Spectrum Disorders

Summary: this is a randomized placebo-controlled trial of cognitive training with transcranial direct current stimulation (tdcs) for children and adolescents (ages 10 - 16 years) with prenatal alcohol exposure (pae).

prenatal alcohol exposure (pae) has profound detrimental effects on brain development and, as a result, has permanent consequences for cognition, learning, and behavior. individuals with fetal alcohol spectrum disorders (fasd) commonly have a range of neurocognitive impairments that directly lead to practical problems with learning, attention, working memory, task planning/execution, and decision making, among other areas of functioning. despite the profound public health burden posed by fasd, there have been very few treatment studies in this population. this study will examine the effects of a cognitive remediation training augmented with tdcs in children and adolescents with pae. functional magnetic resonance imaging will be collected to provide preliminary data of brain circuitry changes created by this intervention. the study involves a baseline visit with cognitive testing, mri, 5 sessions of tdcs (including the baseline visit), and a 6th visit for cognitive testing and mri. all sessions will be completed within a 28 to 56 day time window.

Eligibility criteria:
inclusion criteria: * documented heavy prenatal alcohol exposure (self-report, social service records, or adoption records) and meeting criteria for an associated fasd diagnosis (fas, partial fas, or arnd). * an available parent or legal guardian capable of giving informed consent exclusion criteria: * substance abuse in the participant * neurological condition or other developmental disorder * serious psychiatric disorder known to affect brain functioning and cognitive performance * birthweight \< 1500 grams * mri contraindication * tdcs contraindication
high dose cholecalciferol to reduce the incidence of gestational diabetes in high risk pregnant women

Conditions: Gestational Diabetes

Summary: demonstrate dose-dependent relationship between vitamin d supplementation and rates of gestational diabetes.

determine the effect of increased vitamin d supplementation (4000 iu vitamin d3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes. explore the effect of increased vitamin d supplementation (4000 iu daily + prenatal vitamin), compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic agents and/or insulin, and delivery outcomes among the subset of women who develop gestational diabetes.

Eligibility criteria:
inclusion criteria: 1. women who are currently pregnant and receiving prenatal care at the women's health specialists clinic (university of minnesota physicians) from either md/do or cnm providers 2. subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks) 3. subject possesses as least one of the following characteristics: 1. bmi greater than or equal to 30 kg/m2 2. history of gestational diabetes in a prior pregnancy 3. history of infant with birth weight of 4500g or greater 4. subject is capable of giving informed consent exclusion criteria: 1. age less than 18 years 2. multiple gestation pregnancies (twins, triplets or greater multiples) 3. vitamin d deficiency (defined as less than 20 ng/ml) 4. preexisting diabetes mellitus defined as either: 1. pre-existing diagnosis prior to current pregnancy 2. failure of three-hour glucose tolerance test in first trimester of pregnancy

Keywords: pregnancy gestational diabetes
efficacy and safety of sinovial®hl single injection in the knee osteoarthritis

Conditions: Osteoarthritis of Knee

Summary: the prevalence of knee osteoarthritis (oa) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. while there are several treatment options, there is little consensus in the scientific community over which methods are most effective. viscosupplementation with hyaluronic acid (ha) has been found to reduce pain in patients with knee oa over a period of up to 6 months, with little to no side effects. the aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid ha injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee oa in everyday clinical practice. fifty patients who met the inclusion criteria participated in the study. a single intra-articular ultrasound-guided injection of hybrid ha (sinovial®) was administered. patients submitted visual analog scale (vas) and western ontario and mcmaster universities arthritis index (womac) questionnaires at 28-, 42-, 84-, and 168-days post-treatment.


Eligibility criteria:
the inclusion criteria 1. medical indication for viscosupplementation therapy with hybrid ha 2 patients aged between 45 and 80 years 3.diagnosis of gonarthrosis 4. gonarthrosis symptoms for at least 6 months 5. patients who failed to respond to analgesics and/or regular nsaids, 6. grade 2 to 3 oa in the kellgren-lawrence grading scale 7. pain on walking measured by the visual analog scale (vas; 0-100 mm) of at least 40 mm on the targeted knee; 8. contralateral knee pain when walking with avas of less than 10 mm. the exclusion criteria were: 1. inability to understand the aim of the study 2. inability to provide acceptable consent 3. pregnancy 4. serious psychiatric disorders 5. allergy or intolerance to hybrid ha 6. secondary gonarthrosis due to systematic and inflammatory disorders.

Keywords: knee osteoarthritis hialuronic acid knee function