Kornimate/medical-research-clean huggingface dataset:
prediction of methotrexate response - a pilot study

Conditions: Rheumatoid Arthritis; Rheumatic Diseases

Summary: the objective of this study is to identify genetic predictors of individual methotrexate (mtx) response in patients with rheumatic diseases by determining genetic and metabolomic factors related to nutrient metabolism and drug transport. the development of better genetic predictors of individual mtx treatment response would provide invaluable prognostic information prior to initiating treatment, which would allow more appropriate choice of therapy, decreased adverse events, and more efficient dose-escalation of the drug, with ultimate benefits of improved effectiveness and tolerability rates in patients being treated with mtx for autoimmune diseases. despite being the gold-standard therapy for rheumatoid arthritis and other types of chronic autoimmune diseases since 1951, mtx's efficacy and safety profile limit its use: mtx is discontinued in greater than 50% of patients secondary to inefficacy or poor tolerability. upon initial treatment, discontinuation rates approach 12% because of drug toxicity, despite prophylactic measures such as the co-administration of folic acid. the causes of primary failure, secondary failure, and adverse events of mtx may be related to genetic variation of dihydrofolate reductase (dhfr) and other genes involved in folate metabolism, one-carbon transfer, and drug transport. the purpose of this study is to identify genetic variations involved in methotrexate response so that we may better understand the pharmacodynamics of mtx metabolism in patients with rheumatic diseases.


Eligibility criteria:
inclusion criteria: * all adult patients (i.e. \>18 years of age) who are enrolled at northeast rheumatology at the carolinas medical center - northeast who will be initiating mtx as standard treatment for their particular rheumatic disease, which may include (but not be limited to) conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory-bowel disease related arthropathies, lupus (systemic lupus erythematosus, cutaneous lupus erythematosus), sjogren's syndrome, behcet's disease, systemic sclerosis, and vasculitides. * no prior enrollment into this study * enrollment and initial blood sample collection prior to first mtx administration * written informed consent exclusion criteria: * none

Keywords: methotrexate
effect of rosuvastatin in intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage; Stroke

Summary: the purpose of this study is to determine whether rosuvastatin is effective in the management of acute phase of intracerebral hemorrhage and if it impact outcome by nihss.

the intracerebral hemorrhage (ich) is a frequent problem of health, with high morbid-mortality. in addition it originates expensive expenses in health care systems. ich produces damage by mass effect, then by biochemical ways which are activated and they carry to secondary damage. many studies have been conducted for explaining secondary injury, now we know there are ischemic changes related maybe with changes in cerebral flow and metabolism, in addition to activate inflammatory ways. many drugs and measures has been ineffective for getting best outcome, without success. statins or inhibitors of hmg coa reductase are drugs used in dyslipidemia, frequently for reduction in ldl. experimental and clinical studies in stroke and ich have shown improvement in outcome. the toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins. we have designed this study to demonstrate if the administration of rosuvastatin in the first 24 hours and by 14 days has improvement in outcome.

Eligibility criteria:
inclusion criteria: * men or women \>16 and \< 80 years with ich and hospital attention in less 24 hours * confirmation by ct scan * acceptance by family exclusion criteria: * history of stroke * history of neurological disease, head injury o psychiatric disorder with disability * glasgow less than 9 * administration 24 hours before: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone. * use before hospital of: mannitol, barbiturates, corticosteroids, calcium antagonists * any lesion which needs surgery * allergy to drug used * cerebral death * hepatic disease (child b y c) or myopathy (or) history * management in other hospital * pregnancy * ich major than 60 ml. * hypothyroidism

Keywords: intracerebral hemorrhage statins rosuvastatin stroke
articaine plus dexmedetomidine in supraclavicular block

Conditions: Post Operative Pain, Acute

Summary: articaine has emerged as a local anesthetic (la) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine. studies have shown that adding dexmedetomidine to la produces prolongation of sensory and motor bock duration. early regain of motor power with adequate analgesia is needed in ambulatory surgery, for early start of physiotherapy. this study was designed to test efficacy of adding dexmedetomidine to articaine on the duration of sensory and motor block.

articaine is an amide la produced in the 1960s and first used in clinical trials in 1974. although it is an amide that is similar to prilocaine in chemical structure, it contains a thiophene ring rather than a benzene ring. articaine is a rapid and short acting la, which has low neurotoxicity and appears to diffuse through tissues more readily than other commonly used la agents. it is metabolized by nonspecific plasma esterases both in blood and tissues, leading to its rapid clearance. α2-adrenergic receptor agonists have been the focus of interest for their sedative, analgesic, perioperative sympatholytic, and cardiovascular stabilizing effects along with providing reduction in anesthetic requirements. dexmedetomidine may act on supraspinal (locus coeruleus) or spinal level or peripheral α2-adrenoreceptor to reduce nociceptive transmission, leading to analgesia. previous trials focused on adding dexmedetomidine to either levobupivacaine and bupivacaine, found augmentation of both sensory and motor block along with prolonged duration of effective analgesia. however, there remains limited knowledge of the analgesic efficacy and clinical utility of adding dexmedetomidine to articaine during peripheral nerve block in humans.

Eligibility criteria:
inclusion criteria: * aged 18-60 years planned for upper limb surgery below the midhumerus with an expected time of less than 90 min usually under tourniquet. exclusion criteria: * allergies to local anesthetic, * those with asa iii and iv, * patients who refuse to participate, * uncooperative patients, * patients who have infection at the site of injection, * patients who have bleeding disorder, and patients on anticoagulant drugs.
first time use of sd-809 in huntington disease

Conditions: Chorea

Summary: the purpose of this study is to determine whether sd-809 tablets are effective in the treatment of chorea associated with huntington's disease.

this is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of sd-809 for the treatment of chorea associated with huntington's disease. approximately 90 subjects will be randomized (1:1) into the study, with approximately 45 subjects receiving sd-809 and 45 subjects receiving placebo. the study will be conducted at approximately 30 centers in the u.s. and canada.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age or the age of majority (whichever is older) at screening. * subject has been diagnosed with manifest hd * subject is able to swallow study medication whole. * female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion. * the subject has a reliable caregiver who interacts with the patient on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required. * subject is able to ambulate without assistance for at least 20 yards (note: the use of assistive devices (i.e., walker, cane) is permitted during ambulation). exclusion criteria: * subject has a serious untreated or under-treated psychiatric illness, such as depression, at screening or baseline. * subject has active suicidal ideation at screening or baseline. * subject has history of suicidal behavior at screening or baseline: * subject has evidence for depression at screening or baseline. * subject has an unstable or serious medical or psychiatric illness at screening or baseline. * subject has been recently exposed to tetrabenazine. * subject has received any of the following concomitant medications within 30 days of screening or baseline: * antipsychotics * metoclopramide * monoamine oxidase inhibitors (maoi) * levodopa or dopamine agonists * reserpine * amantadine * memantine * subject has significantly impaired swallowing function at screening. * subject has significantly impaired speaking at screening. * subject requires treatment with drugs known to prolong the qt interval. * subject has a prolonged qt interval on 12-lead ecg at screening. * subject has evidence of hepatic impairment at screening. * subject has evidence of significant renal impairment at screening. * subject has known allergy to any of the components of study medication. * subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of screening, whichever is longer. * subject is pregnant or breast-feeding at screening or baseline. * subject acknowledges present use of illicit drugs at screening. * subject has a history of alcohol or substance abuse in the previous 12 months.

Keywords: huntington disease chorea tetrabenazine
the hemophilia inhibitor prevention trial

Conditions: Hemophilia A Without Inhibitor

Summary: this is a multi-center randomized phase iii clinical trial, the inhibitor prevention trial, in which eloctate will be compared with emicizumab, using adaptive design, to prevent inhibitors in patients with severe hemophilia a.

this is a multi-center randomized phase iii clinical trial, the inhibitor prevention trial, in which consecutive hemostatic agents will be compared using adaptive design to prevent inhibitors in patients with severe hemophilia a. this adaptive design is necessary as randomized trials in rare diseases are otherwise not possible. this adaptive design is necessary as randomized trials in rare diseases are otherwise not possible. the inhibit clinical trials platform includes two linked trials, the inhibitor prevention trial (prevention trial) and the inhibitor eradication trial (eradication trial) that will be conducted at up to 41 u.s. hemophilia treatment centers (htcs) affiliated with universities. the inhibitor prevention trial is a 48-week randomized phase iii trial, in which 66 previously untreated patients (pups) with severe hemophilia a will be enrolled. subjects will include children from 4 months of age up to 4 years of age who have not been previously treated with clotting factor. once enrolled, subjects who meet all the inclusion and none of the exclusion criteria will be randomized to preemptive weekly eloctate (rfviiifc) vs. weekly emicizumab (hemlibra) to prevent inhibitor formation, defined as anti-fviii \>= 0.6 bu. blood draws will be minimized to 6 timepoints, pre, 4, 12, 24, 36, and 48 weeks, and validated for small volumes, 3.8 cc (¾ tsp) each. the inhibitor prevention trial is considered greater than minimal risk as study drug is given before the first bleed and special inhibitor studies are obtained. (nb: the inhibitor prevention trial (pro19040140) is linked to the inhibitor eradication trial (pro19070080), as part of the inhibit clinical trials platform, with both trials will be conducted efficiently in the same hemophilia treatment centers (htcs), with the same mds, coordinators, visit frequency, blood sampling, and assays.

Eligibility criteria:
inclusion criteria: 1. male children \>= 4 months and up to 4 years of age. 2. severe hemophilia a (fviii \< 0.01 u/ml). 3. no evidence of an inhibitor i.e. anti-fviii \< 0.6 b.u. 4. no more than 3 fviii exposures (factor viii concentrate, cryoprecipitate, or fresh frozen plasma), including circumcision. exclusion criteria: 1. acquired hemophilia or any bleeding disorder other than hemophilia a. 2. treatment with clotting factor or emicizumab previously. 3. use of an experimental drug(s). 4. surgery anticipated in the next 48 weeks. 5. life expectancy less than 5 years. 6. parent/caretaker unable or unwilling to keep a personal diary of bleeding frequency and study drug treatment, make monthly visits and blood draws at weeks 4, 12, 24, 36, and 48. 7. other illness, condition or reason in the opinion of the investigator that would make the patient unsuitable for the trial.

Keywords: hemophilia a eloctate emicizumab inhibitor
study evaluating combination of levonorgestrel and ethinyl estradiol in pre-menstrual dysphoric disorder

Conditions: Premenstrual Syndrome; Menstruation Disturbances

Summary: the purpose of this study is to determine whether levonorgestrel/ethinyl estradiol (lng/ee) is effective in treating the symptoms of severe premenstrual dysphoric disorder.


Eligibility criteria:
inclusion criteria: * generally healthy, women aged 18 to 49 years. * history of severe pms symptoms over the last year, as determined by the investigator. * regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. exclusion criteria: * major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years. * contraindication to combination oral contraceptives. * use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study. other exclusion applies.

Keywords: premenstrual syndrome (pms) hormone therapy
salivary c1p and pge2 levels in periodontitis patients with t2dm and effect of non-surgical periodontal treatment

Conditions: Periodontitis; Type 2 Diabetes

Summary: diabetes and periodontal disease are the most common chronic multifactorial and inflammatory diseases in humans, and there is a bidirectional relationship between type 2 diabetes and periodontitis. with the negative effects of the control of these two diseases, it results in an increase in the severity of diabetes and periodontitis, and they affect many systems together. to elucidate the role of ceramide, which is one of the possible biochemical mechanisms between diabetes and the degree of glycemic control and periodontitis, in inflammation. aim of this study is the measurement of c1p and pge2 in saliva and the effect of non-surgical periodontal treatment, which includes the degree of control of diabetes, oral hygiene education, tooth surface cleaning and root surface arrangement, on 3 months. a total of 102 subjects were included. clinical periodontal measurements, saliva samples were collected from each individual at baseline and 3 months after non-surgical periodontal treatmet in periodontitis groups. salivary c1p and pge2 levels were determined by enzyme-linked immunosorbent assay (elisa) method.


Eligibility criteria:
inclusion criteria: * between the ages of 30-65 * have not received periodontal treatment in the last 6 months, * does not have any systemic disease and does not use drugs, * not using local or systemic antibiotics in the last 3 months, * hba1c \<%7 for the controlled t2dm group, * hba1c ≥7% for the uncontrolled t2dm group, * for female patients who are not in the pregnancy or lactation period, * non-smoker, * not regularly using mouthwash/mouthwash. exclusion criteria: * not being willing to participate in the study, * under 30 years old, over 65 years old * having any systemic disease affecting the periodontal condition, * to use any medication that may affect the inflammatory process in the last 3 months, * using local or systemic antibiotics in the last 3 months, * to have had periodontal treatment in the last 6 months, * being in pregnancy or lactation period for female patients, * using mouthwash regularly * smoking

Keywords: saliva prostaglandin e2 ceramide-1-phosphate non-surgical periodontal treatment phase i periodontal therapy saliva biomarker metabolic control hba1c pge2 c1p periodontitis type 2 diabetes mellitus
total knee arthroplasty: comparison of fixed and mobile bearings

Conditions: Knee Osteoarthritis

Summary: the goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.


Eligibility criteria:
inclusion criteria: * patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement * informed consent
march renal substudy

Conditions: Proteinuria; HIV

Summary: chronic kidney disease (ckd) is an emerging problem in patients with treated hiv. antiretroviral therapy associated renal dysfunction has been predominantly described in terms of reduced glomerular filtration (egfr). proteinuria is a key component of ckd and may occur in the absence of significant reductions in egfr. this substudy is an exploration of changes in urinary protein excretion in a randomised, open-label study to evaluate the efficacy and safety of mvc as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (n(t)rti) or boosted protease inhibitors (pi/r) in hiv-1 infected individuals with stable, well-controlled plasma hiv-rna while taking their first n(t)rti + pi/r regimen of combination antiretroviral therapy (cart).

the aim of this substudy of march is to characterize the changes in protein and salt excretion through the kidney utilising the randomised arms of the parent study march. the investigators hypothesize there will be an improvement in proteinuria in those switching to maraviroc containing regimens.

Eligibility criteria:
inclusion criteria: * provision of written, informed consent for participation in the substudy * enrolled into the substudy either at or before the week 0 visit of the main study

Keywords: proteinuria hiv
feasibility of oral sensorimotor stimulation on oropharyngeal dysphagia in children with spastic cerebral palsy

Conditions: Physical Therapy

Summary: children with cp encounter swallow and feeding impairments, especially in infancy and childhood with long meal times with late development of oral motor skills resulting in poor growth.

this study will be conducted to explore the feasibility of oral sensorimotor stimulation combined with sequenced trunk co-activation on oropharyngeal dysphagia in children with spastic quadriplegic cp.

Eligibility criteria:
inclusion criteria * diagnosed as spastic quadrilepgic cp * both genders * aged from 12 to 48 months * scored ≤ 10 on an initial evaluation of oral motor assessment scale. * having at least a problem of oral motor functions (drooling, swallowing, and/or sucking); independent feeding * grade ≥ 2 spasticity according to the mas * level iv and v motor function according to the gmfcs-r\&e. * partial head and trunk control. exclusion criteria * gum and/or dental problems * congenital problems of mouth and soft plate * uncontrolled seizures * any metabolic disorders * cardiopulmonary disorders * significant mental problems.

Keywords: spastic quadriplegia cerebral palsy oropharyngeal dysphagia oral sensorimotor stimulation
prevalence and intervention of hypomagnesemia in users of proton-pump inhibitors

Conditions: Hypomagnesemia, Intestinal, With Secondary Hypocalcemia; Drug Induced Hypomagnesemia

Summary: hypomagnesemia is a severe side effect of longterm use of all available proton-pump inhibitors (ppih). it develops due to intestinal malabsorption of mg2+. this study investigates the application of dietary inulin fibers in users of proton-pump inhibitors with such a hypomagnesemia. to this end, repetitive short-term trials of 14 days of orally administered inulin, separated by a wash-out period of 14 days each were performed in cases of ppih and controls. this study was not blinded or randomized.

hypomagnesemia due to ppi use (ppih) has a low frequency, but is a difficult to control side effect in clinical practice. it develops over years and results in severe symptoms related to the hypomagnesemia. due to the widespread use of ppis, the real number of ppih may be high. currently, there is a lack of intervention strategies and no general treatment protocols for patients exist. it is generally anticipated that ppi-withdrawal and antacid replacement therapy is the only working method to recover patients from the hypomagnesemia. however, this frequently resulted in rebound of gastric acid related complaints. the molecular mechanism of ppih involves a reduction of mg2+ absorption by the large intestine. inulin fibers have been shown to have prebiotic properties. the intestinal microbiome ferments inulin and releases butyrate into the luminal compartment of the intestine. this results in acidification which enhances the uptake of mg2+ and ca2+ mediated by ph-sensitive ionchannels.thus inulin may counteract ppi induced reduction of luminal protons and therefore reestablish normal mg2+ absorption. to this end cases with ppih and controls underwent two 14 day trials of orally administered inulin under separated by wash-out periods of 14 days. during the experimental phase blood measures of electrolytes were monitored.

Eligibility criteria:
inclusion criteria: * chronic ppi use * hypomagnesemia exclusion criteria: * uncontrolled diabetes * irregular use of the inulin fibers

Keywords: hypomagnesemia hypocalcemia inulin fos ppi proton-pump inhibitors
the calgary movement disorders advanced care pilot program

Conditions: Parkinson's Disease and Parkinsonism

Summary: the goal of this clinical trial is to analyse the effect of palliative care interventions on quality of life, patient satisfaction, carepartner burden and health care utilization patterns in patients living with parkisonism and their carepartners. participants will: * receive multidisciplinary palliative care. * answer questions related to the quality of life, patient satisfaction, carepartner burden and health care utilization patterns.


Eligibility criteria:
inclusion criteria: * participants who have a pd diagnosis or another pdrd diagnosis (multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, or lewy body dementia) * participants who have moderate to high pc needs based on the palliative care needs assessment tool (pc-nat) * participants who are between 20 and 100 years old exclusion criteria: * immediate and urgent palliative care needs. these patients will be offered appropriate services immediately * participants who have other illnesses that could require pc e.g. metastatic cancer * participants already receiving pc and/or hospice * patients with a diagnosis of severe cognitive impairment (montreal cognitive assessment \<10). these patients will be offered appropriate services. care partners can participate.

Keywords: palliative care