Kornimate/medical-research-clean huggingface dataset:
implementation of new trauma triage criteria and implications on under- and overtriage.

Conditions: Trauma Injury

Summary: new trauma alert criteria has been introduced in sweden, and our aim in this study is to evaluate the outcome of the old and new trauma alert criteria in a cohort of 1.300.000 inhabitants at six hospitals regarding over- and undertriage and number of alerts initiated. the swedish trauma registry is used to identify eligible patients.

the swedish trauma registry (swetrau) was initiated in 2011, and has up to date 40.000 registered patients. in order to evaluate trauma alert criteria implemented during 2017, we plan a prospective stepped wedge trial at six hospitals in the uppsala/örebro region. these hospitals register in swetrau and all had the same alert criteria prior to the implementation of new alert criteria. a power estimation show the need for 588 patients in each group in order to show a statistical difference between 2-5% undertriage at a 95% ci. the including hospitals has a population base of 1.300.000 inhabitants, and the annual number of trauma alerts has been about 3.000. the registry has information about time of trauma, initiated alerts, injury severity score and mechanism of injury suitable for analysis for our hypothesis.

Eligibility criteria:
inclusion criteria: - all patients registered in swetrau at all including sites between 1 june 2016 and 1 november 2017 exclusion criteria: * patients registered due to secondary referral where the initial assessment was performed at another hospital
platelet antisedimentation rate and multiplate exams in patients on antiplatelet therapy and controls

Conditions: Cerebrovascular Disorders; Platelet Refractoriness; Platelet Aggregation, Spontaneous

Summary: to search for simple laboratory methods selecting patients with low/non-responsiveness to p2y12 receptor antagonists.


Eligibility criteria:
inclusion criteria: * written informed consent exclusion criteria: * declined informed consent
wet cupping therapy in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics

in addition to the medical treatment, wct will be applied once a month, 3 times (day 0, 30, 60) to the intervention group whereas the control group will not receive any intervention. the basfi, basdai, vas and schober test will be applied to both groups at 0 and 3 months.

Eligibility criteria:
inclusion criteria: clinical diagnosis of ankylosing spondylitis 18-65 years of age consent to participate exclusion criteria: any ongoing medical treatment other than nsaids pregnancy at least one contraindication to wct that was detected in subject's history or in the routine blood examinations prior to enrollment (hgb \ 1.2; history of hemophobia, bleeding disorder, malignant disorder).

Keywords: ankylosing spondylitis wet cupping therapy basfi basdai vas
a study in normal healthy people, testing different versions of a pill that will be used to treat rheumatoid arthritis.

Conditions: Rheumatoid Arthritis; Healthy Volunteers

Summary: the study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill ce 224,535 gets released into the bloodstream and whether that is affected by food. in each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. the second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.


Eligibility criteria:
inclusion criteria: * aged 18-55 and healthy exclusion criteria: * severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse * pregnant or wanting to become pregnant

Keywords: pharmacology formulation normal healthy volunteers food effect
study of effects of l-arginine in colitis and colon cancer

Conditions: Ulcerative Colitis; Colon Cancer

Summary: the purpose of this study is to look at the importance of l-arginine in the digestive tract. l-arginine is an amino acid and is important in making proteins within the cell. the evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about l-arginine and ulcerative colitis. the investigators believe these studies will provide new insights into the treatment for inflammatory bowel disease (ulcerative colitis) and nutritional needs. the investigators plan to enroll 200 participants in this study over the next two years.

amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (hplc). cytokines and chemokines are being measured in colon tissues and in serum by luminex assay. cytokines and chemokines are also being measured in colon tissues by real-time polymerase chain reaction (pcr) analysis of mrna expression.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis) * screening for cancer exclusion criteria: * refusal to participate * age less than 18 years at time of colonoscopy

Keywords: ulcerative colitis colon cancer endoscopy screening
effect of transcranial direct-current stimulation in eating behavior of women with fibromyalgia

Conditions: Fibromyalgia; Food Addiction

Summary: introduction: fibromyalgia (fm) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-repairing sleep, cognitive changes, depressive symptoms and other correlates of autonomic dysfunction. a high prevalence of overweight in patients with fibromyalgia is observed, about 80% according to current data, which affects the course and prognosis of the disease, besides overburdening health costs and further compromising quality of life. life of these patients. evidence shows possible pathophysiological pathways shared by these two pathologies, as well as aspects related to food behavior. it is known that dopaminergic neurotransmission is altered in both, suggesting an increase in the sensitivity or density of d2 dopamine receptors. non-pharmacological options for pain management and dysfunctional eating behavior include the important contribution of neuromodulatory techniques of non-invasive cerebral stimulation, such as transcranial direct current stimulation (tdcs), which aims to increase resisting hyperpalatable foods and reducing caloric intake. objectives: to evaluate the association between dopamine receptor-2 (drd2) taq1a allele a1 polymorphism (rs1800497) and to observe the possible effect of tdcs on the dorsolateral prefrontal cortex (dlpfc) on homeostatic and hedonistic aspects of eating behavior in women with fm. methods: a randomized, double blind, parallel group, controlled trial with simulated treatment will be performed. will be included in the study women literate, right-handed, with confirmed diagnosis of fm. the evaluation will be done through questionnaires on pain and eating behavior, anthropometric evaluation and biochemical measurements. the intervention will take place through active or simulated home for 4 weeks. perspectives: to evaluate dysfunctional neuroplastic changes in eating behavior and biological markers and also to serve as a basis for future effective treatment strategies through neuromodulation and nutritional counseling.

a randomized, double-blind, parallel-group controlled trial with sham treatment will be conducted in fibromyalgia patients to assess aspects of eating behavior.

Eligibility criteria:
inclusion criteria: * right-handers who can read and write, * confirmed diagnosis of fm * pain score of six or more on the numerical pain scale (spn 0-10) on most days of the last 3 months. exclusion criteria: living outside the greater porto alegre area and pregnancy. contraindications to emt and etcc: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological disorders; hx of head trauma or neurosurgery; decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, sjogren's syndrome, reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or under treatment. weight loss use and bariatric surgery.

Keywords: polymorphism taq1a tdcs dopamine eating behavior
tideglusib for the treatment of amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a severe neurodegenerative condition, mainly characterized by progressive weakness and wasting of the limbs, the respiratory and bulbar muscles. respiratory insufficiency leads to a fatal outcome after a mean diseases duration of only three to five years. the disease is characterized by pathological accumulations of a protein called tdp-43, which can be found large cortical and sub-cortical areas of post-mortem als brains. no causal treatment for this condition is known to date, and there is a large unmet need to develop new strategies in order to halt or slow down its progression. the aim of this study is to test the safety and tolerability of tideglusib, a treatment that is already in clinical trials for other neuromuscular conditions, in patients with als. it is assumed that this drug may have a significant therapeutic benefit in this population due to his mode of action: in the als mouse model, tideglusib decreases significantly the amount of accumulated tdp-43 proteins within the cells.


Eligibility criteria:
inclusion criteria: * possible, probable (clinically or laboratory supported) or definite als according to the revised version of the el escorial criteria * disease duration \< 18 months * vital capacity of more than 60% of normal (defined as slow vital capacity, best of three measurements) * age more than 18 years * on a stable dose of riluzole for at least four weeks or not taking riluzole * on a stable dose of edaravone for at least four weeks or not taking edaravone * capable of thoroughly understanding all information given and giving full informed consent according to gcp exclusion criteria: * previous participation in another clinical study within the preceding 12 weeks * proven sod1- or fus - mutation * tracheostomy or assisted ventilation of any type during the preceding three months * pregnancy or breast-feeding females * any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of als * presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment * evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms * alcoholism * cardiovascular disorder/arrhythmia * impaired kidney function, defined as creatinine levels of 2.5 x upper limit of normal (uln) * impaired liver function, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) of 3 x uln * liable to be not cooperative or comply with trial requirements as assessed by the investigator, or unable to be reached in the case of emergency
concentrated growth factors in regenerative therapy in furcation involvements in humans

Conditions: Concentrated Growth Factors; Periodontal Regeneration; Furcation Defects

Summary: objective: to compare the effect of guided tissue regeneration (gtr) + concentrated growth factors (cgf) + bone graft and cgf + bone graft in the treat of ii° furcations of human mandibular molars. methods: at least thirty ii°furcation involvements in mandibular molars will be included and randomly divided into two groups. the experimental group will accept gtr + cgf + bone graft therapy, and the control group will accept cgf + bone graft therapy. the clinical examination and cone beam computed tomography (cbct) will be performed at baseline and 1 year post-surgery.


Eligibility criteria:
inclusion criteria: * ii° furcation involvements in mandibular molars * after periodontal therapy. exclusion criteria: * not healthy
simultaneous coronary artery evaluation and lung cancer ct screening

Conditions: HEAVY SMOKING

Summary: cardiac computed tomography (ct) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. this pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose ct protocol that allows concomitant coronary artery evaluation and lung screening. current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo ct assessment of either thoracic area only or both coronary arteries and thoracic area. primary end-points will be the effective contrast and radiation doses.

cardiac computed tomography (ct) scan is an ideal diagnostic tool for identifying coronary artery disease in patients with low or intermediate risk. in recent years, cardiac ct is being often performed in patients who are at high risk either for coronary artery disease or lung cancer. the update edition of the national institute for health and care excellence (nice) guidelines recommends cardiac ct as the first-line diagnostic tool for patients with new-onset chest pain due to suspected coronary artery disease. also, symptomatic patients with known coronary artery disease and previous percutaneous coronary intervention who have an unclear stress test but whose presentation suggests a high likelihood of having an in-stent restenosis or a 'de novo' stenosis might benefit from cardiac ct. in 2014, the u.s. preventive services task force recommended annual lung cancer screening with ultra-low dose computed tomography for current and former heavy smokers aged 55 to 80 years. indeed, lung cancer screening in patients with suspected or known coronary artery disease undergoing cardiac ct may provide the opportunity to implement recommendation for lung cancer screening in clinical practice.this pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose ct protocol that allows concomitant coronary artery evaluation and lung screening. current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo ct assessment of either thoracic area only or both coronary arteries and thoracic area. primary end-points will be the effective contrast and radiation doses.

Eligibility criteria:
inclusion criteria: * symptomatic subjects with effort-induced or typical chest pain * high probability of coronary artery disease * known coronary artery disease * willing to participate to the study * informed consent to undergo ct scan exclusion criteria: * contraindications to iodinated contrast such as allergies and chronic kidney failure * any suspicion of pregnancy
relief study: real-world evaluation of luts interventions and patient experience during follow-up

Conditions: Benign Prostatic Hyperplasia

Summary: the objective of the relief study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic bph.


Eligibility criteria:
inclusion criteria: * diagnosis of symptomatic bph exclusion criteria: * prior surgical intervention for treatment of bph * unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments
laser therapy and temporomandibular disorders

Conditions: TMD

Summary: tmd involves a set of multiple clinical manifestations where the pain is prevalent. treatment ideally should be noninvasive and innocuous such as photobiomodulation


Eligibility criteria:
inclusion criteria: * pain at tmj area. * pain at masseter and temporalis muscles. * age ranges between 20 and 40 years old. * presence of full or nearly full complement of natural teeth exclusion criteria: * patients who have radiographic evidence of degenerative conditions of tmj. * patients under current dental or physical therapy that could affect tmd. * history of recent trauma. * the presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis). * pregnant and lactating females
low-intensity blood flow restriction training as a pre-operative rehabilitative modality to improve post-operative outcomes for acl reconstruction

Conditions: ACL Injury

Summary: researchers are trying to find out whether the use of low-intensity strength exercises during the 2 weeks before surgery, and while the blood flow to the leg is reduced, will improve the outcomes after surgery to repair an injured ligament of the knee.


Eligibility criteria:
inclusion criteria: * subjects must be between 13 and 40 years old * subjects must have been previously diagnosed with a tear of the anterior cruciate ligament in one of the lower extremities that requires surgical reconstruction * subjects must be able to understand study procedures and comply with them for the entire duration of the study * subjects must have normal contralateral limb strength exclusion criteria: * subjects with any personal history of deep vein thrombosis or with such history in their immediate family * subjects who have any multi-ligamentous injuries to the knee that require modified post-operative unloading * subjects who have history of previous anterior cruciate ligament reconstructions in either the affected or unaffected leg * subjects with an inability or unwillingness of individual or legal guardian to give written informed consent
olopatadine eye drops and allergy skin testing

Conditions: Allergic Rhinitis; Allergic Conjunctivitis

Summary: use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.


Eligibility criteria:
inclusion criteria: * adults aged 18 to 75 years * healthy volunteers (no major illnesses or active symptoms) exclusion criteria: * known allergy or hypersensitivity to the drugs or components * pregnant or nursing women * women wishing to become pregnant during the study's duration * use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization * dermatographism as evidenced on skin testing on visit 1 * chronic urticaria active within the past 6 months * severe hypertension * psychiatric diagnoses which could potentially affect medication compliance, such as schizophrenia or delusional disorders, as determined by the investigator obtaining informed consent and based on the subject's past medical history * inability to provide informed consent

Keywords: allergy skin testing eye drops antihistamines
multicenter, randomized, double-blind, placebo controlled, efficacy study on the effects of tolvaptan on left ventricular dilatation in congestive heart failure patients

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to study the effects of tolvaptan on the size and function of the left heart chamber (ventricle) in patients with congestive heart failure (chf)


Eligibility criteria:
history of congestive heart failure

Keywords: chf
compassionate use treatment for a single patient with a custom made branched/fenestrated endovascular device for the treatment of complex abdominal aortic aneurysm

Conditions: Complex Abdominal Aortic Aneurysm

Summary: the fenestrated aaa endovascular graft with the h\&l-b one-shot™ introduction system is neither commercially available or available as part of a clinical trial. irb approval of this protocol was requested so that cook, incorporated may apply to the fda for approval for one-time use of this patient-specific device for compassionate use for patient ao. it is a custom made endovascular device consisting of4 fenestrations for the celiac, sma (superior mesenteric) and left and right renal arteries.

the custom made branched/fenestrated endovascular device to be used in this treatment plan is not food and drug administration (fda)-approved, and is approved for use only in a clinical study. however, the fda has allowed the use of this device for compassionate use. the devices used are tubular grafts made of polyester fabric sewn to metal stents. the upper part of the grafts includes fenestrations (holes) that allow the grafts to be located above or near major arteries that branch off of the aorta (celiac artery, superior mesenteric artery (sma), and renal arteries) without blocking blood flow to them. the celiac artery supplies blood to internal organs including the liver and stomach. the sma supplies blood to internal organs as well, including parts of the large and small intestines. the renal arteries supply blood to the kidneys. grafts with branches and/or fenestrations are needed when the aneurysm is located near these major arteries. the major arteries that branch off of the aorta (celiac artery, sma, and renal arteries) may also be treated using stents (small tubular metal structures) to help keep the arteries open and aligned with the graft fenestrations (holes).

Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: complex abdominal aortic aneurysm
a study of tazemetostat on safety in participants with relapsed or refractory follicular lymphoma with enhancer of zeste homolog 2 (ezh2) gene mutation in japan

Conditions: Lymphoma, Follicular

Summary: the primary purpose of the study is to investigate the safety of tazemetostat in participants with relapsed or refractory follicular lymphoma with ezh2 gene mutation under daily clinical practice.


Eligibility criteria:
inclusion criteria: 1. participants with relapsed or refractory follicular lymphoma with ezh2 gene mutation 2. participants treated with tazemetostat exclusion criteria: 1. participants with a history of hypersensitivity to any ingredient of tazverik

Keywords: e7438 tazemetostat tazverik
shared decision making in parents of children with acute otitis media

Conditions: Acute Otitis Media

Summary: this study will evaluate the efficacy of shared decision making in treatment of acute otitis media in the emergency department setting.

the investigators long-term goal is to promote evidence-based, patient-centered evaluation in the acute care setting to more closely tailor antibiotic use to disease risk for acute otitis media (aom) in children. the investigator will conduct a single-center cluster randomized control trial comparing the efficacy, safety and patient-centered outcomes of the shared decision-making decision aid 'acute otitis media choice' to usual care among children diagnosed with acute otitis media in the ed for whom antibiotics are being considered to engage parents in shared decision-making.

Eligibility criteria:
inclusion: 1. 6 months to 18 years in age 2. acute otitis media diagnosed (aom) at the time of visit, defined as: * middle ear effusion- demonstrated by pneumatic otoscopy, air fluid level, or a bulging tympanic membrane plus * evidence of acute inflammation- opaque, white, yellow, or erythematous tympanic membrane or purulent effusion plus * symptoms of otalgia, fussiness or fever exclusion: 1. are currently on antibiotics 2. have acute otitis media and another diagnoses that antibiotics are prescribed for 3. have otitis-conjunctivitis syndrome 4. have perforation of their tympanic membrane at time of diagnoses 5. recurrent aom defined as: 1. ≥3 or greater separate aom episodes in the previous 6 months or 2. ≥4 or more greater aom episodes in the previous 12 months with one in the last 6 months 6. have a craniofacial abnormality 7. have had previous ear tubes placed 8. have an immunologic disorder 9. are immunosuppression either by disease or medication 10. are undergoing treatment for cancer :