Kornimate/medical-research-clean huggingface dataset:
an observational study to assess the real-world effectiveness of upadacitinib in adult participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. ra can reduce the ability to perform everyday tasks. this study will assess the clinical and patient-reported outcomes with upadacitinib in adult participants with moderate-to-severe ra in a real-world setting. upadacitinib is an approved drug for the treatment of adults with moderately to severely active ra who have had an inadequate response or intolerance to methotrexate. adult participants with moderate-to-severe ra will be enrolled. around 150 participants will be enrolled in the study in multiple sites in the united kingdom. participants will receive upadacitinib per their physician's usual prescription. individual data will be collected for 6 months. no additional study-related tests will be conducted during the routine physician visits. only data which are routinely collected during a regular visit will be utilized for this study.


Eligibility criteria:
inclusion criteria: * american college of rheumatology (acr) or european league against rheumatism (eular) confirmed diagnosis of rheumatoid arthritis (ra). * moderate ra (defined by national institute for health and care excellence \[nice\] as 28-joint disease activity score \[das28\] c-reactive protein \[crp\] \>3.2 and ≤5.1) or severe ra (defined by nice as das28 crp \>5.1) at the time of enrollment. * prescribed upadacitinib in line with marketing authorization. * decision to treat with upadacitinib has been made independently and prior to enrolment in the study. * able to read and understand english. * willing and able to participate in the collection of patient-reported data via mobile app. exclusion criteria: * first dose of upadacitinib received prior to enrollment in the study (same day permitted) or more than 28 days after enrolment into the study. * previously received \>4 biologic disease-modifying antirheumatic drugs (bdmard) (1 switch to a biosimilar for non-clinical reasons is allowed for each bdmard received) or any janus kinase (jak) inhibitor for the treatment of ra. * in the opinion of the treating clinician, participant symptoms are predominately being driven by fibromyalgia or unrelated pain component instead of underlying inflammatory disease. * participation in any interventional clinical trial within the 3 months prior to initiation or at any point during the study observation period.

Keywords: rheumatoid arthritis (ra) upadacitinib rinvoq
assessment of grazax® treatment compliance

Conditions: Allergy

Summary: this trial is performed to assess whether the grazax® treatment compliance can be improved by use of a compliance device (memozax®).


Eligibility criteria:
inclusion criteria: * grass pollen induced rhinoconjunctivitis * males and females, 18-65 years of age * positive skin prick test exclusion criteria: * previous treatment with grass pollen allergen

Keywords: allergy
multimodal exercise program on parkinson's disease patients with depression

Conditions: Parkinson's Disease

Summary: depression symptoms are common in parkinson's disease, it affects health-related quality of life. the evidence showed that exercise improved depression and hrqol in pd patients. however, studies rarely considered the appropriate exercise program for pd patients, we want to find the best exercise program for pd patients.

objective: evaluate the effectiveness of a 8-week multimodal exercise program on depression and hrqol in pd patients. methods: single-blinded, randomized controlled trial, from march 2016 to january 2017. ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n = 49). the primary outcomes were depression and hrqol; the secondary outcomes were activity of daily living, motor ability, fatigue, sleep quality and anxiety. data collection at baseline, week 4 and 8 after intervention. intervention were multimodal exercise program, at least three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to accumulate 150 minutes a week for 8 weeks.

Eligibility criteria:
inclusion criteria: * be diagnosed pd in hoehn and yahr stage i-ii22 * under stable medication treatment at least 3 months * no disease limiting the patient's ability to perform the exercises exclusion criteria: * severe cardiovascular disorders * neuromusculoskeletal disorder * cognitive impairment * recent participation in any physiotherapy or rehabilitation program * have exercise regularly

Keywords: parkinson's disease a multimodal exercise program aerobic exercise depression health related quality of life
histones and free-plasma dna after cardiac arrest

Conditions: Heart Arrest; Hypothermia; Post Cardiac Arrest Syndrome

Summary: to evaluate the significance of free-plasma deoxyribonucleic acid (dna) and plasma histones in cardiac arrest patients.


Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest of presumed cardiac cause * return of spontaneous circulation (rosc) * glasgow coma score \< 8 * age \> 18 years and \< 80 years exclusion criteria: * \>60 minutes from the circulatory collapse to rosc * time interval \> 4 hours from cardiac arrest to initiation of targeted temperature management * terminal illness * coagulation disorder * unwitnessed asystolia * cerebral performance category 3-4 before the cardiac arrest * severe persistent cardiogenic shock * pregnancy * persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment) * new apoplexy or intracerebral hemorrhage * lack of consent from the relatives * lack of consent from the general practitioner * lack of consent from the patient if he/she wakes up and is relevant
tamoxifen versus anastrozole, alone or in combination with zoledronic acid

Conditions: Breast Cancer

Summary: the primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (dfs) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. to assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.

the trial is conducted as an open multi-center phase iii study, in a two-factorial study design and according to good clinical practice (gcp) guidelines. patients will be randomly assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. several stratification criteria will be used in order to ensure balanced distribution of known risk factors. a total of 1.803 patients will be enrolled in 4 arms. patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm a: nolvadex alone; arm b: nolvadex plus zoledronate; arm c: arimidex alone; arm d: arimidex plus zoledronate). zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. five bone mineral density (bmd) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).

Eligibility criteria:
inclusion criteria: * premenopausal, hormone receptor-positive patient * histologically verified (minimally) invasive breast cancer, local radical treatment * 0-9 involved axillary lymph nodes (≥ 10 histologically examined nodes) * tumor stage: pt1b-3, yt0 or yt1a exclusion criteria: * t1a, t4d, yt4; m1 * previous breast tumor irradiation * previous or concurrent chemotherapy (except for preoperative chemotherapy) * serum creatinine \> 1.5 x unl or creatinine clearance \< 60 ml/min

Keywords: austrian breast & colorectal cancer study group (abcsg) 12 phase 3 breast cancer anastrozole tamoxifen zoledronic acid premenopausal hormone receptor-positive stage i stage ii bone mineral density bmd bisphosphonate zoledronate
the role of peptide yy (pyy)infusions in inhibiting food intake.

Conditions: Obesity

Summary: the aim of the study is to compare fasting and postprandial pyy levels between overweight/obese and lean subjects during and after an infusion of saline, pyy1-36 or pyy3-36 and to evaluate the efects on appetite, energy intake and energy expenditure.

the study is a randomised dobbelblinded placebo controlled study with 24 male subjects ( 12 lean and 12 overweight/obese subjects). vas scores are used to assess appetite and two ad libitum meals are served in the hours following the infusion. energy expenditure is measured by ventilated hood system and blood is sampled during part of the study day.

Eligibility criteria:
inclusion criteria: * normal weight (bmi: 18-23 kg/m2) or 12 overweight/obese (bmi: 27-40 kg/m2) * body weight fluctuations \< 5 kg over the past 2 months. * blood pressure normal to mildly hypertensive (\<159/99 mm hg) * non-elite athletes and not planning to change physical activity during the study. exclusion criteria: * any physiological or psychological illnesses that could influence the study results * regular use of medicine * smoking defined as \<1 cigarette per day. * substance abuse or dependence. * blood donation within the past 3 months before entering the study * drinking \>21 alcoholic units/week. * food allergies. * special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.
prevention and treatment of immersion pulmonary edema

Conditions: Immersion Pulmonary Edema (IPE); Swimming Induced Pulmonary Edema (SIPE)

Summary: immersion pulmonary edema (ipe) is a condition in which fluid fills the lungs during diving or swimming, particularly in cold water. some individuals appear to be predisposed to developing ipe. dna samples will be collected and stored, in order to compare the genetic profiles of individuals who have experienced ipe with those who have not. in a few individuals who have experienced ipe, we plan to measure the effects of cold water immersion on the blood pressure, cardiac output and the pressures in the pulmonary artery. these will be compared with similar measurements already obtained from normal individuals.

immersion pulmonary edema (ipe) is a condition that has sudden onset in swimmers and divers, and is characterized by cough, shortness of breath, decreased blood oxygen levels, and hemoptysis. the purpose of this study is to examine the effects of cold water immersion and the dive reflex on pulmonary arterial pressure and pulmonary capillary wedge pressure in those who have already experienced ipe, as well as explore the possibility of a genetic predisposition. healthy nonsmoking subjects who have experienced ipe will be recruited for several cold-water immersion experiments and dna analysis. their pulmonary arterial and pulmonary arterial wedge pressures will be measured as they undergo immersed rest and exercise trials in thermoneutral and cold water. if the pressures increase with these trials as hypothesized, the effects of sildenafil administration (a pulmonary vasodilator) will be tested during a second trial. blood will also be drawn for dna analysis of certain genes with possible relation to ipe. results of these tests will be compared with those of the general population.

Eligibility criteria:
inclusion criteria: * history of immersion pulmonary edema exclusion criteria: * coronary artery disease, cardiomyopathy, heart valve disease

Keywords: immersion pulmonary edema diving swimming pulmonary edema cold water immersion
study of biostate® in children with von willebrand disease

Conditions: Von Willebrand Disease

Summary: this is an open-label study to investigate the pharmacokinetics (pk), efficacy, and safety of a von willebrand factor/factor viii (vwf/fviii), biostate, in children with von willebrand disease (vwd) in whom treatment with a vwf product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.


Eligibility criteria:
inclusion criteria: * male and female subjects between 0 and \<12 years of age * diagnosed with vwd type 1, 2a, or 3 * desmopressin acetate (ddavp) treatment is ineffective, contraindicated, or not available for subject * von willebrand factor: ristocetin cofactor (vwf:rco) is \<20% at screening or the subject has a history of vwf:rco \<10% * evidence of vaccination against hepatitis a and b or presence of antibodies against hepatitis a and b due to either a previous infection or prior immunization * written informed consent given exclusion criteria: * active bleeding immediately prior to initial pk period * received treatment with ddavp or a vwf concentrate product for their vwd in the 5 days prior to their first study treatment * have received aspirin or other non-steroidal anti-inflammatory drugs (nsaids) within 7 days of commencing the pk period. * known history or suspicion of having vwf or fviii inhibitors * acute or chronic medical condition, other than vwd, which may affect the conduct of the study * known or suspected hypersensitivity or previous evidence of severe side effects to other fviii/vwf concentrates * participation in a clinical study or use of an investigational compound in another study in the 3 months preceding study start * unwillingness and/or inability to comply with the study requirements

Keywords: von willebrand disease
intestinal fatty acid binding protein in very low birth weight infants with meconium obstruction

Conditions: Meconium Obstruction of Prematurity

Summary: urinary intestinal fatty acid binding protein (i-fabp), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (nec). however, there are no data on urinary i-fabp in meconium obstruction of prematurity (mop). this study aimed to evaluate urinary i-fabp in mop patient as a marker for early detection.


Eligibility criteria:
inclusion criteria: * preterm infants weighing \<1,250g exclusion criteria: * major congenital anomalies * perinatal asphyxia (cord ph \<7.0)
sub-cutaneous insulin in hyperglycaemic emergencies

Conditions: Diabetes Mellitus

Summary: hyperglycaemic emergencies are associated with significant mortality (mortality in diabetic ketoacidosis 0.65 - 3.3% and in hyperosmolar non-ketotic coma 12 -17%). to reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. the study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.

this is a randomised trial concerning patients presenting in a \& e with a diabetic emergency, either a diabetic ketoacidosis (dka) or a hyperosmolar non-ketotic coma (honc). once informed consent has been given, each patient will receive standard intravenous treatment. they will also receive a daily sub-cutaneous bolus of either a long-acting insulin or a placebo. blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood ph.

Eligibility criteria:
inclusion criteria: * patients presenting with a diabetic emergency aged 18 and above. exclusion criteria: * patients who do not speak english and need a translator. * patients under the age of 18 years. * patients who are unable to give their consent and who do not have a relative present wiling to give assent.

Keywords: diabetes emergencies
plant stanol esters and covid-19 vaccination response

Conditions: Overweight and Obesity

Summary: plant stanols are known to lower low-density lipoprotein cholesterol (ldl-c). however, studies have suggested that these compounds also beneficially influence the immune system, e.g. increasing vaccine-specific antibody titers. bmi has previously been negatively associated to vaccination responses. if plant stanols indeed have beneficial effect on the immune system, people with overweight or obesity might benefit from consuming plant stanols prior to receiving the covid-19 vaccination. the primary objective of this study is to demonstrate clinical benefits of consumption of plant stanols (delivered via products enriched with plant stanol esters) on the vaccination response to a covid-19 vaccine in overweight or obese patients. the main study endpoint is vaccination response to a covid-19 vaccine. secondary endpoints include amongst others hematological, inflammatory and immunological parameters (e.g. hs-crp, leukocyte differential count) and metabolic markers (e.g. blood lipid profiles, plasma glucose, serum insulin, homa-ir).


Eligibility criteria:
inclusion criteria: * men and women * aged 18 years or older * bmi between 27 and 35 kg/m2 * currently not using products containing plant sterols or stanols (products with a cholesterol lowering claim of becel proactiv, benecol, danacol, store brands) * willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of becel proactiv, benecol, danacol, store brands) * willing to keep the intake of fish oil and vitamin supplements constant exclusion criteria: * already received covid-19 vaccination * already had a positive test for covid-19 (this includes all types of tests, e.g. pcr tests or antibody tests) * allergy to an ingredient of the mini drinks * having donated blood within one month prior to the start of the study, or planning to donate blood during the study * pregnant women * breastfeeding women * excessive alcohol use (\>20 consumptions per week) * regular use of soft or hard drugs

Keywords: overweight obesity covid-19 vaccine immune system vaccination response
examination of lower urinary system symptoms with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy; Lower Urinary Tract Symptoms; Muscle Weakness; Posture Disorders in Children; Lumbar Lordosis; Pelvic Floor Muscle Weakness; Quality of Life

Summary: the aim of this study is to examine the prevalence of lower urinary tract symptoms (luts) in children with duchenne muscular dystrophy (dmd) and the relationship between functional level, posture, muscle strength, pelvic floor muscle control, participation in activities of daily living, and quality of life that may be associated with these symptoms. forty-five children with dmd between the ages of 5-18 (age: 9.00±3.32 years, weight: 31,10±12,59 kg, height: 125,87±18,46 cm) and their families were included in the study. luts was assessed with dysfunctional voiding and incontinence scoring system, functional level with brooke upper extremity functional classification and vignos scale, posture with the new york posture assessment questionnaire, baseline bubble inclinometer (10602, fabrication enterprises inc. new york, usa) and baseline digital inclinometer (12-1057, fabrication enterprises inc, new york, usa), participation in activities of daily living was assessed with the barthel index and quality of life was assessed with the pediatric quality of life inventory 3.0 neuromuscular module. also, using the hoggan microfet2 (hoggan scientific, llc, salt lake city ut, usa) device, hip flexors, quadriceps femoris muscles, shoulder flexors, elbow extensors, elbow flexors, trunk extensors and flexors were evaluated in terms of muscle strength. evaluations were made once, and the associated factors were compared in the group with and without luts, and the relationship between the factors and the severity of luts was examined.


Eligibility criteria:
inclusion criteria: * having been diagnosed with dmd by a specialist physician as a result of gene analysis and/or muscle biopsy, * being between the ages of 5-18, * volunteering by parents to participate in the study and reading and signing the informed consent form. exclusion criteria: * having a diagnosed neuromuscular disease other than dmd and/or with dmd, * having a diagnosed psychiatric and/or metabolic disease, * having a diagnosis of autism spectrum disorders, * presence of congenital and/or acquired anomalies that may affect communication, * the family and/or the child has a problem of cooperation in completing the assessments for any reason, * using a catheter and/or a diaper all day, * having difficulty in understanding and speaking the turkish language.
analgesic effect of beta 2-mimetics in the treatment of neuropathic pain

Conditions: Postthoracotomy Pain; Postthoracoscopy Neuropathic Pain

Summary: neuropathic pain is due to a lesion or disease affecting the nervous system. antidepressants (ads) are recommended as the first line treatment. in a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. these data support the idea that β-mimetics could offer a therapeutic alternative to ads for neuropathic pain treatment. this study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.


Eligibility criteria:
inclusion criteria: * adults from 18 to 75 years old * neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months exclusion criteria: * cardiovascular risk * unstable diabetes mellitus * allergy for terbutaline * hypokaliemia without treatment * untreated hypothyroidism * hiv- or chemotherapy-induced neuropathy * cancer being treated by chemo- or radio-therapy * concomitant treatment with β-blockers, tricyclic ads or morphine * concomitant pain more severe than neuropathic pain- pregnant women
treatment of partial reversible chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: relatively little information is available about the effects of salmeterol/fluticasone combination and fluticasone alone in copd patients with a partial reversible pulmonary obstruction. the purpose of this study is to compare the effects of salmeterol/fluticasone combination with fluticasone alone delivered via diskus/accuhaler inhaler in subjects with copd on lung function over a 1 year period.

multi-centre, double-blind, randomised and stratified parallel group study to compare the efficacy and safety of fluticasone propionate 500 mcg bd versus salmeterol/fluticasone combination 50/250 mcg bd both via diskus inhaler during 1 year in chronic obstructive pulmonary disease(copd) patients with a partially reversible obstruction.

Eligibility criteria:
inclusion criteria: * established history of chronic obstructive pulmonary disease (copd). * lung function parameters: fev1/fvc ratio \< 70%, fev1 between 80% and 30% predicted, a reversibility of airway obstruction of 12% of the initial value with a minimum of 200 ml. * signed and dated informed consent. exclusion criteria: * history of asthma or allergy. * unstable copd in the 3 months before the study. * interference of non-pulmonary medication or diseases with copd outcome parameters.

Keywords: reversibility copd lung function
cone beam and ct scan for the diagnosis of otosclerosis (tacos)

Conditions: Otosclerosis

Summary: computed tomography scan (ct) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis. the cone-beam computed tomography (cbct) is a imaging technique with reduced irradiating and, therefore, could replace the ct. in this study, a cbct will be proposed to all patients undergoing a ct exam for the diagnosis and/or the pre-operative assessment of an otosclerosis. the results of the cbct will be compared to those of the ct scan.


Eligibility criteria:
inclusion criteria: * ct scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis exclusion criteria: * pregnancy * breast feeding * patient under a legal protection procedure * patient denying to participate to the study * lack of affiliation to a social security system