Kornimate/medical-research-clean huggingface dataset:
tocilizumab remission in early ra

Conditions: Rheumatoid Arthritis

Summary: the tremera study focuses on patients with newly diagnosed, untreated, rheumatoid arthritis (ra). recent international treatment recommendations emphasise the need to diagnose ra early and start treatment immediately (this being associated with better response rates); and to aim for the goal of remission i.e. the absence of signs and symptoms of active inflammatory disease activity which is associated with better outcomes for the patient. remission is more achievable with significant treatment advances that have been made in the form of highly effective biologic therapies. tocilizumab (tcz) is a newly introduced biologic drug that is used in established ra. the tremera study primarily aims to investigate the biological changes seen in blood and tissue following tcz therapy this will contribute to a better understanding of how the drug works as well as disease processes; and will also identify whether administering a biologic drug such as tcz can also switch off immunological parameters associated with a disrupted immune system of ra. the study will assess the effectiveness of tcz given on its own or in combination with methotrexate (mtx; a standard therapy usually given with biologic treatments)in patients with early onset ra to determine the proportion that achieve remission. this study also aims to find out how quickly remission can be achieved with tcz and the depth of remission achieved. this will be done using usual clinical assessment but also imaging such as ultrasound and magnetic resonance imaging (mri) which can detect inflammation not apparent on clinical assessment.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (2010 acr/eular ra classification criteria) * symptom duration ≤12months * no previous disease modifying antirheumatic drug (dmard) therapy * active ra at baseline (defined as: das28 ≥ 3.2) * active hand and/or wrist joint evaluable by us and mri (with no planned surgery during the study period) * patients without any contraindication to mri exclusion criteria: * patients unwilling or unable to receive mtx for the duration of the study. * patients with inflammatory joint disease of different origin, mixed connective tissue disease, reiter's syndrome, psoriatic arthritis, systemic lupus erythematosis, or any arthritis with onset prior to 16 years of age. * suspicion of diagnosis of tuberculosis (tb): positive quantiferon +/abnormal chest x-ray, as per clinician judgement. prior history of tb with confirmed full chemotherapy +/latent tb adequately treated may be included as per physician's discretion. * intramuscular, oral or intraarticular (of non-target joint) corticosteroid within 28 days of the screening visit; intra-articular steroid of the chosen target joint within 12 weeks of screening. * patients with serious infections within 3 month of enrolment (screening) or persistent infections. * patients at significant risk of infection (e.g. leg ulceration, indwelling urinary catheter, septic joint within 1 year (or ever if prosthetic joint still in situ). * known positive serology for hepatitis b or c, or hiv
dapagliflozin in physical exercise in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: inhibitors of sodium-dependent glucose-transporter 2 (sglt-2 inhibitors, including dapagliflozin) inhibit glucose reabsorption in renal tubular cells, hereby increasing glycosuria in the hyperglycemic state. its mechanisms of action are independent of insulin, which makes sglt-2 inhibitors a potential adjunct to insulin in type 1 diabetes mellitus (t1dm). however, a higher risk for diabetic ketoacidosis (dka) was reported in patients with t1dm taking sglt-2 inhibitors. dka depends on an accumulation of ketone bodies in the blood stream, which equals an accumulation of acids that lead to acidosis. the underlying mechanisms of this observation are unknown. ketone body production depends on the molar ratio of glucagon to insulin, with insulin suppressing but glucagon stimulating ketone body production. this translates into higher production during relative insulin deficiency, carbohydrate deficiency, and prolonged fasting, which occurs during sickness but also physical exercise. physical exercise is a recommended cornerstone in the treatment of t1dm and current treatment guidelines recommend both, reductions of insulin doses and ingestion of additional carbohydrates to avoid hypoglycemic events. these adaptions might increase relative insulin deficiency, hyperglycemia and glycaemic variability, which might in turn promote ketone body production. the addition of sglt-2 inhibitors further may promote ketogenesis even though there are reports of sglt-2 inhibitors increase glucagon-like-peptide-1 (glp-1) in patients with t1dm. glp-1 is a suppressor of glucagon secretion. in summary, knowledge about the effects of sglt-2 inhibition on ketone body production is scarce, especially during exercise in patients with t1dm. the study seeks to illustrate the effect of sglt-2 inhibition on glycemic variability and ketone body production during and after recreational exercise in patients with t1dm. the results of study 2 will provide the basis for future studies investigating the underlying mechanisms of potentially modified ketone body production during and after exercise under sglt-2 inhibition.


Eligibility criteria:
inclusion criteria: * written informed consent * diagnosis of t1dm * duration of t1dm \> 5 years * male or female sex * insulin therapy via multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) * body mass index (bmi) between 20 and 29 kg/m2 * adherence to sufficient contraceptive measures (double barrier method combining hormonal with mechanical barriers). * ability to perform a 60 minutes exercise session at 50% vo2max. exclusion criteria: * diagnosis of renal and/or hepatic dysfunction * history of malignancy of any kind * intake of drugs influencing glucose homeostasis during the last three months * alcohol or drug abuse * inadequate vein status on both forearms * active smoker * known pregnancy, positive plasma beta human choriogonadotropine test prior to study inclusion or intention to become pregnant during the study period.
bivalirudin in acute myocardial infarction vs glycoprotein iib/iiia and heparin :a randomised controlled trial.

Conditions: Acute Myocardial Infarction; Percutaneous Coronary Intervention

Summary: the study would enrolled a total of 2100 ami patients undergoing pci to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein iib/iiia inhibitor. all enrolled patients would be followed-up to 30 days, 6 months, and 1 year. the purpose of the study is to evaluate the efficacy and safety of bivalirudin in ami patients with des.

this is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 2100 ami patients undergoing percutaneous coronary intervention (pci) to one of three antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone, or unfractionated heparin plus a glycoprotein iib/iiia inhibitor. all enrolled patients would be followed-up to 30 days, 6 months, and 1 year. the purpose of the study is to evaluate the efficacy and safety of bivalirudin in ami patients with des.

Eligibility criteria:
inclusion criteria: 1. age 18 to 80 years old 2. planned emergency pci for acute myocardial infarction (stemi or nstemi) symptom onset within 12h for stemi (or within 24 h for patients have unrelieved chest pain, continuous st elevation or new developed lbbb) symptom onset within 72h for nstemi 3. avoid to undergoing revascularization for non-culprit vessels within 30 days after index procedure. 4. provide written informed consent. exclusion criteria: 1. unsuitable for pci; treatment by thrombolysis within 72 hours of acute st-elevation myocardial infarction; left main coronary artery disease; cardiogenic shock. 2. any anticoagulant agents were used 48 h before randomization. 3. active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), gi or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.; 4. other disease may lead to vascular lesions and secondary bleeding factors (such as active gastric ulcer, active ulcerative colitis, intracranial aneurysm, etc.), 5. deep puncture or major surgery (including eye or brain surgery) within 1 month. 6. suspicious aortic dissection, pericarditis and subacute bacterial endocarditis. 7. untreated or uncontrolled hypertension \> 180/110 mmhg. 8. hemoglobin \< 100 g/l or platelet count \< 100 \* 109 / l. 9. elevated ast, alt level higher than three times of the normal upper limit. 10. severe renal insufficiency (egfr \< 30 ml/min / 1.73 m2). 11. heparin induced thrombocytopenia. 12. known allergy to the study drugs and instruments (ufh, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution. 13. pregnancy or lactation. 14. researchers think that doesn't fit to participate in this study.

Keywords: bivalirudin acute myocardial infarction percutaneous transluminal coronary angioplasty
virtual reality (vr) during peripheral nerve evaluation (pne) procedure

Conditions: Overactive Bladder

Summary: the purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (pne).


Eligibility criteria:
inclusion criteria: * adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction exclusion criteria: * have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study * significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancers, etc., which could compromise the physical function of the headset
safety and efficacy study of hydromorphone and morphine

Conditions: Pain

Summary: to compare a standard weight-based dose of intravenous (iv) hydromorphone (dilaudid) to a standard weight-based dose of iv morphine in adults presenting to the emergency department (ed) with acute severe pain.

there is widespread agreement that pain is under-treated in the emergency department (ed). the current recommended treatment of acute pain in the ed setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved. several studies have shown that even 0.1 mg/kg iv morphine (7-10 mg administered to the average 70-100 kg patient) inadequately treats many patients' acute pain. in spite of this, it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial iv dose. in contrast, it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone (1-1.5 mg), perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine, thus providing the illusion of substantially less opioid administered to the patient. having repeatedly observed this phenomenon, it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy, safety, and side-effect profile comparable or superior to a larger milligram dose of morphine, it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ed. as a practical corollary to this, it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ed.

Eligibility criteria:
inclusion criteria: * adults between the ages of 21 and 65 who presented to the ed with acute pain (defined as pain less than 7 days in duration) (23) of sufficient severity in the judgment of the ed attending to warrant use of iv opioids. exclusion criteria: * previous allergy to morphine or hydromorphone * systolic blood pressure less than 90 mmhg * alcohol intoxication as judged by the attending physician * use of other opioids within the past 7 days * use of an monoamine oxidase (mao) inhibitor * chronic pain syndromes (such as sickle cell disease or fibromyalgia)

Keywords: acute pain emergency department morphine hydromorphone dilaudid oligoanalgesia
differential pressure distribution orthosis by 3d printing process in the treatment of post-burn hypertrophic scarring

Conditions: Burns; Hypertrophic Scar

Summary: this is a pilot, single-center, feasibility study to evaluate a new 3d printing method for ordp design. to our knowledge, there is no technical or clinical evaluation of ordps, particularly in the treatment of hypertrophic scars. the aim of our study is therefore to assess the feasibility of an innovative method of designing ordps for the curative treatment of post-burn hypertrophic scars, using a 3d printing process, and to describe the procedures (production time and cost).


Eligibility criteria:
inclusion criteria: * adult patients aged \> 18 years old * patient with at least one hypertrophic burn scar in the process of healing localized on a skin area that can benefit from a compression garment and requiring the use of an ordp * patient able to give informed consent * patient affiliated to a social security scheme exclusion criteria: * patients under guardianship, curatorship or safeguard of justice * pregnant or breast-feeding women
fenretinide in children with recurrent/resistant all, aml, and nhl

Conditions: Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma

Summary: the purposee of this study is to determine the safety and dosing of fenretinide when given continuously for 5 days, every 3 weeks, in pediatric patients with recurrent and/or resistant acute lymphoblastic leukemia (all), acute myelogenous leukemia (aml), and non-hodgkin's lymphoma (nhl).

fenretinide is a cytotoxic retinoid that has activity against a variety of cell lines in vitro in a dose-related manner. the exact mechanism of fenretinide cytotoxicity in leukemia and lymphoma cell lines is not known, but may include the de novo ceramide synthesis of ceramides and the generation of reactive oxygen species. the malignancy-specific nature of fenretinide-induced ceramides suggests that combinations of the drug with other ceramide modulating agents may have a favorable therapeutic index. in this study, the primary aims are to define the maximum tolerated dose, toxicity profile, and pharmacokinetics of iv fenretinide when given continuously in pediatric patients with all, aml, and nhl. the drug will be administered via a central venous or percutaneous indwelling central catheter in an inpatient hospital setting.

Eligibility criteria:
inclusion criteria: * diagnosed with relapsed or refractory all, aml, or nhl * must have had two or more therapeutic attempts for treating/curing disease * must have fully recoved from acute toxic effects of all prior therapy * karnofsky of greater than 50% for older than 10 years of age and lansky greater than 50% for younger than 10 years. exclusion criteria: * grade 2 pruritus or rash (all forms) * grade 3 dry skin that is refractory to topical medical management * cardiac fractional shortening \< 27% on echocardiogram * left ventricular ejection fraction \< 45% on echocardiogram * known allergy to egg products or soy bean oil * renal, liver, and pancreatic function: * serum creatinine \> 1.5x uln * direct bilirubin \> 1.5x uln * alt or ast \> 2.5x uln * serum trigylcerides \> 2.5x uln for age * lipase \> 1.5x uln for age * history of pancreatitis

Keywords: leukemia,lymphoma
trigger point injections versus lidocaine patch for myofascial pain in the emergency department

Conditions: Myofascial Trigger Point Pain; Myofacial Pain

Summary: the aim of this trial is to investigate the efficacy of trigger point injections with 1% lidocaine in reducing myofascial back and neck pain in the emergency department compared to lidocaine patches 5%.

after being informed about the study and the potential risks and benefits, all patients will be randomized into either the trigger point injection group with 1% lidocaine, or the 5% lidocaine patch group. pain scores will be recorded while in the emergency department, and we will have a 5 day follow-up phone call to assess efficacy. patients who present to uci department of emergency medicine will be screened and recruited prospectively, and information regarding this study will be available on clinicaltrials.gov as a method of recruitment.

Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosed with myofascial pain of the posterior neck or back. \*the diagnosis of myofascial pain was based on established criteria of having a palpable taut band (trigger point) that when depressed reproduced the patient's pain. exclusion criteria: * midline spinal tenderness * evidence of radiculopathy * pregnant * have an allergy to lidocaine * altered or deemed incapable of making informed consent * had signs of infection or skin breakdown over the trigger point.

Keywords: pain management emergency department trigger point injections lidocaine patches myofascial pain interventional pain medicine
adaptive cognitive training in healthy older adults

Conditions: Mild Cognitive Impairment; Mild to Moderate Dementia; Alzheimer's Disease

Summary: cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate cognitive function in older adults and individuals with dementia. in recent years, such training has become particularly appealing in the clinical context, with many paradigms aimed specifically at adults experiencing various stages of cognitive decline due to mild cognitive impairment, alzheimer's disease, and vascular dementias. however, basic questions remain. for example, uncertainty persists regarding factors that influence observed improvements as well as the conditions that would maximize transfer and sustainability of training effects. the objective of this study is to evaluate factors that may maximize the benefits of computerized cognitive training in older adults.

the study involves 25 sessions of an adaptive cognitive training program, completed over 5 weeks. pre and post training assessments will evaluate any near and far transfer effects of training.

Eligibility criteria:
inclusion criteria: * english as the maternal or primary spoken language. * good self-reported health (i.e., no cerebro-, or cardio-vascular disease or neurological disease). * normal or corrected-to-normal vision and hearing. exclusion criteria: * poor hearing or vision * inadequate understanding of the english language
sensor glove and non-invasive vibrotactile feedback insole to improve hand prostheses functions and embodiment

Conditions: Amputation; Traumatic, Hand

Summary: state-of-the-art myoelectric prostheses provide upper limb amputees with a remarkable variety of grip patterns but lack proper feedback from touch sensation. this restriction limits the controllability of multi-articulated robotic hands, resulting in the rejection of the device in many cases. amputees have often reminiscing sensations in the stump, i.e. by touching certain regions, it feels as if no longer existing fingers were touched. these regions form a phantom map and show promising results for touch feedback. however, not every amputee has one and the socket of a prosthesis offers limited space for additional devices. thus, the investigators developed a feedback display which is worn in the shoe instead of the prosthesis itself. the investigators want to assess the viability of vibrotactile feedback stimulus on the foot as a substitution for pressure on the fingers of an artificial hand in a clinical study. the efforts are based on the hypothesis that a hand prosthesis with tactile feedback has better performance in manipulating fragile and heavy objects, compared with a standard commercial hand prosthesis without tactile feedback.


Eligibility criteria:
inclusion criteria: * sign the consent form * have basic knowledge of and trust in modern technologies * understand the experimental procedures and are willing to participate in the study * unilateral below- or above-elbow amputee * familiar with the usage of a myoelectric prosthesis exclusion criteria: * any form of skin disease * contraindication in the device, e.g. hypersensitivity or allergy against materials used in the device * impaired condition * known or suspected abuse of alcohol or drugs * unable to follow the instructions given during the experiments * participation at another clinical study with drugs or devices within 30 days before the study at hand * homeless person * enrollment of the head of studies, his/her family members, employees or other dependent persons

Keywords: myoelectric prostheses closed-loop control vibrotactile feedback feedback display
the effect of inactive and active vitamin d on serum sclerostin/dickkopf1 levels

Conditions: Osteoporosis

Summary: the purpose of this study is to compare the effect of inactive and active vitamin d on serum sclerostin and dickkopf1 levels.


Eligibility criteria:
inclusion criteria: * healthy male volunteer older than 20 years exclusion criteria: * subjects with bone and mineral metabolism disorders * subjects with kidney or liver diseases * subjects with uncorrectable hypercalcemia or hypocalcemia * subjects with chronic gastrointestinal disorders or malabsorption * subjects taking medication related to bone loss

Keywords: vitamin d serum sclerostin serum dickkopf1
a retrospective study to evaluate the effectiveness and benefit of onabotulinumtoxina in patients with chronic migraines

Conditions: Chronic Migraine, Headaches

Summary: this study will evaluate the effectiveness and benefit of treatment with onabotulinumtoxina in chronic migraine patients who have received a minimum of 7 treatment cycles.


Eligibility criteria:
inclusion criteria: * 15 or more headache days over a 30 day period * a minimum of 7 treatment cycles with onabotulinumtoxina exclusion criteria: * any treatment cycle dose of onabotulinumtoxina greater than 200 units
italian observational study assessing the impact of gout on patients disability and quality of life

Conditions: Gout

Summary: the study aims to identify which characteristics are associated with disability and poor quality of life in patients suffering from gout. this is a multicentre prospective observational study carried out in a cohort of italian patients with gout. subjects are randomly selected from a list of patients referred to each participant rheumatology clinic in the previous 2 years. clinical evaluations are performed at baseline, at 6 and 12 months; data are retrieved about sociodemographic variables, life-styles, history of gout, comorbidities and patterns of treatment. at each visit patients complete questionnaires assessing disability and health-related quality of life. preplanned analyses will be performed to investigate predictors of disability and poor quality of life in these patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of gout * must be able to understand questionnaires exclusion criteria: * diagnosis not validated by rheumatologist * not able to sign informed consent

Keywords: gout gouty arthritis