Kornimate/medical-research-clean huggingface dataset:
a phase iv study to evaluate the effect of subcutaneous (sc) tocilizumab administered to participants with rheumatoid arthritis (ra) assessed using disease activity score (das28)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this clinical trial is to prospectively evaluate ra activity using the assessment of change in das28 under local conditions in slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the ministry of health of the slovak republic in order to better assess the disease activity and impairment of the joint function.


Eligibility criteria:
inclusion criteria: * participants with age greater than or equal to (\>=) 18 years * participants with moderate to severe active ra (das28 \>=3.2) who did not respond sufficiently to or did not tolerate previous treatment with one or several disease-modifying antirheumatic drugs (dmards), irrespective of whether they were of biological or synthetic nature * participants eligible for the treatment with subcutaneously administered tocilizumab, as decided by the doctor in accordance with summary of product characteristics (spc) and standard therapeutic procedures, who were not previously treated with tocilizumab and did not receive any other biological treatment for ra in the past either * assignment of participants for observation using the treatment described above is clearly separated from the physician's decision to prescribe the treatment to the patient. * pulmonologist's consent for chest x-ray and quantiferon test with commencement of biological treatment exclusion criteria: * hepatitis b surface antigen (hbsag,) hepatitis c virus (hcv) or human immunodeficiency virus (hiv) positivity * history of severe allergic or anaphylactic responses to human or humanized murine monoclonal antibodies * history of intestinal ulcerations or diverticulitis * active hepatopathy with more than threefold increase of alanine transaminase (alt) or aspartate transaminase (ast) * thrombocytes \<100,000 per cubic milliliters (/mm\^3), less than (\<) 3,000 mm\^3, absolute neutrophil count \< 2,000 mm\^3 * women of childbearing age (without medically confirmed sterility, e.g. following hysterectomy, ovariectomy, menopause lasting 2 years) who do not accept the use of a suitable form of contraception (e.g. barrier methods of contraception in the participant and partner, contraceptive pills or patches, hormonal implants, spermicidal agents in combination with barrier method of contraception, intrauterine device)
sustainable method for alzheimer's prediction

Conditions: Alzheimer Disease; Amnestic-Mild Cognitive Impairment

Summary: this is an observational study with the aim of validating, in a consistent population sample, with appropriate follow-up, whether eeg connectivity analysis combined with the neuropsychological evaluation and apoe genotype testing in amci could be of help in early identification of converted amci as a first-line screening method in order to intercept early those subjects with a high risk for rapid progression to ad.

primary aim of the present project is to investigate the dynamic connectivity among brain centers by using a mathematical (small world) approach to the analysis of eeg-related neural networks. the aim is to provide reliable discrimination of amnesic-mild cognitive impairment (a mci) subjects who, on individual basis, will rapidly convert to alzheimer disease (ad) after a relatively brief follow-up. moreover, keeping in mind that the epsilon-4 allele of the apoe gene is a genetically determined risk factor for pathogenesis of late-onset ad, a secondary endpoint is introduced to investigate whether the eeg connectivity markers together with a genetically determined risk of dementia as represented by apoe testing can reach higher sensitivity/specificity for early discrimination of mci converting to ad

Eligibility criteria:
exclusion criteria for ad will be: * frontotemporal dementia; * behavioural variant of frontotemporal dementia; * vascular dementia; * extra-pyramidal syndromes; * reversible dementias (including pseudodementia of depression); * lewy body dementia. the exclusion criteria for amci will be: * mild ad, as diagnosed by standard protocols including national institute on aging-alzheimer's association workgroups (mckhann et al. 2011); * evidence (including magnetic resonance imaging -mri procedures) of concomitant dementia such as frontotemporal, vascular and reversible dementias (including pseudo-depressive dementia), marked fluctuations in cognitive performance compatible with lewy body dementia and/or features of mixed dementias; * evidence of concomitant extrapyramidal symptoms; * clinical and indirect evidence of depression as revealed by the geriatric depression scale gds (yesavage et al. 1982); scores lower than 14 (no depression); * other psychiatric diseases, epilepsy, drug addiction, alcohol dependence, use of neuro/psychoactive drugs including acetylcholinesterase inhibitors; * current or previous uncontrolled or complicated systemic diseases (including diabetes mellitus) or traumatic brain injuries.
initial experience with a novel single-balloon enteroscopy system in children with ibd

Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Summary: to evaluate the safety and efficacy of the naviaid™ ab in children with known or suspected ibd.

in 15%-25% of diagnosed inflammatory bowel disease (ibd) cases, disease manifestation begins before the age of 18. ibd primary includes crohn's disease (cd) and ulcerative colitis (uc). studies have shown that the current incidence of pediatric ibd ranges from 4-7 cases per 100,000, worldwide. early and accurate diagnosis of ibd is important for correct prognosis, course of disease, therapeutic decisions and follow-up. complete diagnostic work-up is key to proper diagnosis in patients.early diagnosis of ibd and differentiation between uc and cd can be difficult in children. the major issues that face pediatric ibd today include accurate disease classification, unknown extent of disease, complete bowel visualization, inability to reach depth of findings, and biopsy retrieval for diagnostic work-up. the naviaid™ ab device presents a new and unique concept that helps overcome these short comings of ibd diagnosis and treatment. through repetitive inflation and deflation of the naviaid™ ab, the endoscope can be swiftly advanced deep into the small bowel via the proximal or distal route, allowing for complete visualization of the small bowel and easy biopsy sampling for histopathology. as a result, subsequent diagnoses can influence proper action for further treatment and therapy for the patient. although many studies have reported on the safety and efficacy of balloon enteroscopy in adults with ibd, further investigation of the value of balloon enteroscopy in pediatric patients with known or suspected ibd is still required. this is a single-center, non-randomized open-label study intended to evaluate the safety and efficacy of the naviaid™ ab device during small bowel enteroscopy in children with known or suspected ibd.

Eligibility criteria:
inclusion criteria: 1. patients between the ages 8-18 2. patients with known or suspected ibd (including crohn's disease or ulcerative colitis). 3. the patient/parent of patient must understand and provide written consent for the procedure. exclusion criteria: 1. subjects with known coagulation disorder; 2. subjects with known hernia; 3. subjects with suspected stricture or stenosis; 4. any patient condition deemed too risky for the study by the investigator 5. subjects who are currently enrolled in another clinical investigation.

Keywords: inflammatory bowel diseases colitis, ulcerative crohn disease single-balloon enteroscopy naviaid ab™ device naviaid ab™ procedure ab device pediatric ibd pediatric enteroscopy
pilates in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study was planned to examine and compare the effectiveness of two different pilates exercise methods (mat pilates vs reformer pilates) in individuals with ankylosing spondylitis(as).


Eligibility criteria:
inclusion criteria: * being in the age range of 20-65, using stable medication for at least 3 months, being sedentary (not regularly participating in exercise activities for the past 3 months). exclusion criteria: * the presence of cardiovascular, pulmonary, orthopedic and neurological problems, another rheumatic disease, being pregnant, inability to participate in at least 75% of the exercises.
dietary advanced glycation end products and migraine

Conditions: Nutrition Disorders; Migraine Disorders

Summary: is dietary intake of advanced glycation different between individuals with and without migraine? is there a difference between the groups in terms of energy and nutrients? the answers to these questions are sought.


Eligibility criteria:
inclusion criteria: * to be diagnosed with episodic migraine by an experienced neurologist, * for the control group, patients who were not diagnosed with migraine but applied to the headache outpatient clinic * volunteer exclusion criteria: * being younger than 19 years and older than 64 years of age, having a history of cardiovascular disease, hypertension, diabetes, cancer, liver and kidney disease or other neurological disorder (epilepsy, multiple sclerosis, stroke, traumatic brain injury, etc.), secondary headache, antilipidemic and glucose taking intolerance medications or vitamin-mineral supplements, following a special diet, and consuming less than 800 kcal or more than 4000 kcal per day
cannabis for palliative care in cancer

Conditions: Sleep; Anxiety; Depression; Pain

Summary: many cancer patients suffer from pain, sleep, and mood problems and are using cannabis to relieve these symptoms. cannabis may provide such relief but may also produce negative side effects including cognitive impairment, an especially problematic issue for cancer patients, indicating more research on cannabis use in the cancer context is required. in this endeavor, the present study seeks to compare the use of hemp-derived cbd (cannabidiol) with and without thc (delta-9-tetrahydrocannabinol) versus placebo on measures of sleep, pain, mood, subjective and objective cognitive functioning, and quality of life within 185 cancer patients.


Eligibility criteria:
inclusion criteria: 1. able to provide informed consent 2. aged ≥25 years at visit 1 (baseline) 3. have a diagnosis of any solid tumor type and is currently undergoing or has undergone either curative or palliative treatment in the past 18 months 4. currently experiencing symptoms of sleep problems, pain, and/or mood disturbance (i.e., depression, anxiety) 5. desire to use cannabis to treat their symptoms 6. must not have been regularly using any cannabis products (more than 3x/month) in the last 6 months 7. willing to practice acceptable methods of birth control until completing study medication exclusion criteria: 1. report of illegal drug use (e.g., cocaine, methamphetamine) in the past 90 days 2. current use of anti-epileptic medications (e.g., clobazam, sodium valproate, lamotrigine) 3. current use of medications known to have major interactions with epidiolex (e.g., buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide) 4. current use of anti-psychotic medications 5. current use of potent cyp2c19 or cyp3a4 inducers (e.g., rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, st. john's wort, fosphenytoin, mitotane, phenobarbital, primidone) 6. liver function tests (alanine transaminase \[alt\] and aspartate transaminase \[ast\]) levels ≥2x the upper normal limits 7. moderate or severe liver disease 8. past or current diagnosis, or family history of diagnosis, of psychosis; current major psychiatric illness, such as bipolar disorder, major depression, or schizophrenia 9. history of seizures 10. for female participant of childbearing potential: pregnant or lactating at the time of study enrollment or trying to become pregnant. lack of childbearing potential confirmed by a history of amenorrhea for at least 12 consecutive months and serum fsh level within the laboratory's reference range for postmenopausal females or documented bilateral oophorectomy and/or hysterectomy 11. physician response to passive consent indicating contraindications for participation. 12. unwilling to refrain from cannabis use other than study drug for the entire study duration 13. men who consume more than 2 alcoholic beverages per day and women who consume more than 1 alcoholic beverage per day
eus-rfa for unresectable pancreatic cancer

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the clinical application of intraoperative or percutaneous radiofrequency ablation (rfa) for pancreatic ductal adenocarcinoma (pdac) is limited due to higher mortality and incidence of adverse events. the aim of this study was to evaluate the efficacy and safety of endoscopic ultrasonography-guided rfa (eus-rfa) for locally advanced, unresectable pdac. patients with unresectable pdac who underwent eus-rfa were included from september 2013 to june 2016. pre- and post-procedural clinical data was retrospective collected.

evaluate the efficacy and safety of endoscopic ultrasonography-guided rfa (eus-rfa) for locally advanced, unresectable pdac.

Eligibility criteria:
inclusion criteria: * age 20 to 80 years old. ② unresectable pdac based on review of abdominal cross-sectional imaging (ct or mri) and cytology/ histology results. ③intolerance to chemotherapy due to side effects or patient's comorbidities. exclusion criteria: * pregnancy or breast-feeding；②ecog performance status 3 or 4；③patients with distant metastases or malignant ascites, life expectancy less than 3 months.

Keywords: pancreatic ductal adenocarcinoma unresectable pancreatic cancer radiofrequency ablation endoscopic ultrasound
presence of the arcade of struthers on preoperative ultrasound

Conditions: Cubital Tunnel Syndrome

Summary: to determine the correlation between the presence of the arcade of struthers on preoperative ultrasound and during endoscopic surgery for cubital tunnel syndrome, and to determine the reliability of a portable ultrasound probe to detect the arcade of struthers in the arm.

the ulnar nerve comes from the medical cord of the brachial plexus (c8-t1). it travels out of the axilla along the medial border of the arm to pass into the forearm via the cubital tunnel at the elbow. cubital tunnel syndrome is the result of compression and traction on the ulnar nerve about the elbow, which can occur at multiple sites. the most proximal possible site of compression causing is the arcade of struthers. this entity has been described as an aponeurotic band, as a fibrous canal or as thickened connective tissue. regardless of the nomenclature, ulnar nerve compression has been documented at the location of the arcade of struthers, which is 6 to 10 cm proximal to the medial epicondyle. simple open in situ decompression typically results in decompression of the ulnar nerve 6 cm proximal and 6 cm distal to the medial epicondyle while endoscopic ulnar nerve decompression decompresses on average 17 cm of the ulnar nerve (range 25-23 cm), thus consistently reaching the area of the arcade of struthers. recurrent cubital tunnel syndrome after simple decompression can be due failure to the release of the arcade of struthers, and the revision surgery involved extending the incision and length of ulnar nerve release. with the advances in ultrasound imaging, the identification of the arcade of struthers in mid arm is feasible. hence, it would be beneficial to identify the presence and the location of the arcade of struthers pre-operatively, to direct the surgical procedure to decompress the ulnar nerve more proximally in cases of a simple decompression in situ.

Eligibility criteria:
inclusion criteria: * diagnosis of cubital tunnel syndrome * planned for endoscopic cubital tunnel release primary surgery * \>=18 years of age * no previous arm or elbow surgeries exclusion criteria: * revision surgery * planned for open cubital tunnel release * prior surgical intervention around the arm or the elbow * \<18 years of age

Keywords: arcade of struthers cubital tunnel
effect of gastrectomy and anastomosis on diabetes and hypertension in early gastric cancer patients

Conditions: Early Gastric Cancer

Summary: the purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.


Eligibility criteria:
inclusion criteria: * histologically proven primary gastric adenocarcinoma * clinical stage ia or ib examined with endoscopy, endoscopic ultrasound, and computed tomography * aged 20-80 year old, * performance status (ps) of 0 or 1 on eastern cooperative oncology group (ecog) scale * diagnosed as diabetes or hypertension * patients planning to undergo gastrectomy or endoscopic submucosal dissection * written informed consent exclusion criteria: * having high risk for operation such as severe heart disease, severe respiratory disease * pregnant * previous abdominal surgery or radiation therapy * proven more advanced disease than pathological stage ii requiring adjuvant chemotherapy

Keywords: early gastric cancer, diabetes, hypertension
trial to describe the safety, tolerability, and immunogenicity of trumenba when administered to immunocompromised participants ≥10 years of age

Conditions: Meningococcal Vaccine

Summary: the aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.


Eligibility criteria:
inclusion criteria: * male or female participants ≥10 years of age at the time of consent. * participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies. * negative urine pregnancy test for all female participants. exclusion criteria: * previous vaccination with any meningococcal serogroup b vaccine. * participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. * history of microbiologically proven disease caused by n meningitidis or neisseria gonorrhoeae. * significant neurological disorder or history of seizure (excluding simple febrile seizure). * any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. * any confirmed or suspected human immunodeficiency virus infection. * other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment. * current chronic use of systemic antibiotics. * previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab). * participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.

Keywords: meningococcal vaccine meningitis vaccine asplenia sickle cell anemia complement deficiencies
effect of lower back treatment in people with patellofemoral pain syndrome.

Conditions: Patellofemoral Pain Syndrome

Summary: the purpose of this study is to determine if a lower back treatment would change the knee pain intensity and the level of functional activities as well as the muscle activities in people with anterior knee pain. the investigators hypothesized that the lower back treatment may change the hip and knee muscle activities as well as reduce the knee pain intensity and improve the functional activities in people with anterior knee pain.


Eligibility criteria:
inclusion criteria: * insidious onset of symptoms of non-traumatic origin. * pain with patellar facet palpation or compression. * anterior or retropatellar knee pain during at least two of the following activities: (a) ascending stairs, (b) descending stairs, (c) kneeling, (d) squatting, (e) hopping, (f) running, (j) jumping, (h) prolonged sitting for more than 20 minutes. exclusion criteria: * history of spine, hip or knee surgery. * history of hip pathology or other knee condition. * current significant injury of any lower extremity joints. * pregnancy. * sign of nerve root compression. * osteoporosis or history of compression fracture.
the role of tlr4 on lipid-induced insulin resistance

Conditions: Insulin Sensitivity

Summary: the purpose of this study is to determine whether pharmacologic inhibition of toll-like receptor 4 (tlr4) with eritoran for injection (e5564) prevents lipid-induced insulin resistance in lean, normal glucose tolerant (ngt) subjects.

e5564 = eritoran

Eligibility criteria:
inclusion criteria: * subjects capable of giving informed consent. * lean (bmi \<26 kg/m2) * normal glucose-tolerant subjects (completers) without a family history of type 2 diabetes mellitus (dm) * both genders. (50% males) * age = 18-65 years. older subjects are excluded because aging is a pro-inflammatory state. * all ethnic groups * premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. postmenopausal women on stable dose of or not exposed to hormone replacement for \>=6 months. * lab: hematocrit \>=34%, serum creatinine \<=1.4 mg/dl, normal electrolytes, urinalysis, and coagulation tests. liver function tests up to 2x normal range. * stable body weight (+/-1%) for \>=3 months. * one or less sessions of strenuous exercise/wk for last 6 months. exclusion criteria: * presence of diabetes or impaired glucose tolerance based on ada criteria; * current treatment with drugs known to affect glucose and lipid homeostasis. subjects on a stable dose of statin (\>3months) are eligible. * non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months. * current treatment with anticoagulants (warfarin). aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies. * history of heart disease (new york heart classification greater than class ii; more than non-specific st-t wave changes on the ecg), peripheral vascular disease, pulmonary disease, smokers. * poorly controlled blood pressure (systolic bp\>160, diastolic bp\>90 mmhg). * active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.

Keywords: insulin signaling and glucose disposal in muscle hepatic insulin sensitivity tlr4 signaling and inflammatory gene expression plasma cytokine concentration intramyocellular diacylglycerol and ceramide content