Kornimate/medical-research-clean huggingface dataset:
schema, emotion and behavior-based therapy for school children

Conditions: Autism Spectrum Disorder

Summary: the study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (cbt) relative to a standard community treatment, in youngsters with autism spectrum disorder (asd). the individual cbt program has been tailored over the last five years to the clinical needs of high-functioning youth with asd.

autism spectrum disorder (asd) is among the most common childhood developmental disorders. a key goal in the field is the discovery of methods that reduce core autism symptoms. core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors. the core symptoms tend to be stable and resistant to intervention. most treatments involve group-based social skills training (sst), with limited effects. no treatment for core autism symptoms in school-aged children with asd meets american psychological association guidelines for possible efficacy. cognitive behavioral therapy (cbt) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. initial results suggest that individual cbt may also be promising for reducing core autism symptoms (wood et al., 2009b; drahota, wood et al., 2011). the treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing the use of deep semantic processing to enhance memory retrieval. we are proposing a randomized controlled trial to examine the efficacy of individual cbt relative to a standard community treatment for youngsters with asd.

Eligibility criteria:
inclusion criteria: * meets research criteria for a diagnosis of autism, based on child scores on the adi-r and ados tests. * if taking medication, have maintained a stable dose for 1 month prior to baseline assessment. * between the ages of 6-9 years. * the child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment. exclusion criteria: * iq less than 85. * the child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period. * the child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime. * for any reason the child or parents appear unable to participate in the treatment program.

Keywords: intervention autism treatment sensitivity school aged cognitive behavioral therapy social skills intervention
developing e-liquid product standards (sweet spot study)

Conditions: Nicotine; Nicotine Vaping; E-cigarette Use

Summary: the sweet spot study aims to evaluate the effect of e-liquids with nicotine varying in freebase (fb) levels and concentrations on the appeal of electronic cigarettes (ecs) in young adult ec users with minimal/no history of smoking and older adult smokers.


Eligibility criteria:
inclusion criteria: 1. young adult e-cigarette user or older adult smoker 2. willing to abstain from all nicotine product use for 12 hours prior to the study visit 3. read and speak english exclusion criteria: 1. currently attempting to quit nicotine products 2. currently pregnant, planning to become pregnant, or breastfeeding 3. current or past use of tobacco products other than e-cigarettes or cigarettes 4. self-reported diagnosis of lung disease 5. self-reported new or unstable cardiovascular disease
low level laser therapy and expression of vegf, no, vegfr-2, hif-1α in diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to examine the changes of factors including vascular endothelial growth factor(vegf), vegfreceptor-2, nitric oxide and hypoxia-inducible factor-1α (hif-1α), measurements of oxygen saturation in peripheral blood and wound surface area and ankle-brachial index (abi) in ischemic diabetic foot ulcers after low level laser therapy(lllt).

defects in vessels and neovascularization makes diabetic chronic wounds difficult to treat, a decrease of angiogenic factor expression such as vascular endothelial growth factor(vegf) and its receptors is involved in angiogenesis inhibition in diabetic ulcers. lllt as a therapeutic treatment modality can effect on release of these factors and angiogenesis in wound site. the purpose of this study is to examine the changes of factors including vegf, vegfreceptor-2, nitric oxide and hypoxia-inducible factor-1α (hif-1α), measurements of oxygen saturation in peripheral blood and wound surface area in ischemic diabetic foot ulcers after lllt, therefore, the investigators can evaluate molecular process of angiogenesis, as a mechanism of useful effects of lllt. in order to patients with ischemic diabetic foot ulcers(dfu) assigned into lllt with ga-as(904 nm) laser and placebo groups and will be treated for 12 sessions, every other day. on the first and last (twelfth) treatment session, before and after intervention, blood sample are taken from all patients in the both groups for vegf, vegfreceptor-2, no and hif-1α measurement. wound surface area and oxygen saturation of peripheral blood and ankle-brachial index (abi) are measured at first and twelfth treatment.

Eligibility criteria:
inclusion criteria: * ischemic diabetic foot ulcer * wagner classification dfu 2 * 0.5\<abi\<0.9 * mild to moderate diabetic neuropathy exclusion criteria: * fracture in a lower limb * a severe infection * a malignancy * kidney failure * skin diseases * osteomyelitis * pregnancy
investigation of muscle oxygenation in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the aim of this study is to investigate respiratory muscle strength, respiratory muscle endurance, muscle oxygenation, upper extremity and lower extremity exercise capacity in rheumatoid arthritis patients compared with healthy individuals.

rheumatoid arthritis (ra) is a chronic progressive autoimmune disease of unknown etiology with symmetric erosive synovitis and multisystem involvement. the disease causes significant long-term morbidity, reduced functional capacity, and increased mortality rates. patients with rheumatoid arthritis avoid physical activity due to pain and fatigue. despite the advances in pharmacological treatments in recent years, functional losses due to rheumatic diseases the resulting deterioration in quality of life, and loss of work continue. physical inactivity is known to have detrimental effects on the cardiovascular and pulmonary systems by reducing muscle strength and aerobic capacity. the physiological reasons underlying skeletal muscle oxygenation that may cause muscle dysfunction in rheumatoid arthritis have not been investigated. in these patients, decreased arterial oxygen may reduce exercise capacity and cause muscle deoxygenation. in rheumatoid arthritis patients, decreases in respiratory muscle strength, lung volumes, oxygen consumption, and six minute walk test distance cause cardiopulmonary deconditioning. decreased exercise capacity increases the risk of cardiovascular disease and causes mortality in patients with ra. this study aimed to, the effects of respiratory muscle strength, respiratory muscle endurance, upper and lower extremity muscle oxygenation, and upper and lower extremity exercise capacity in patients with stable disease activity.

Eligibility criteria:
rheumatoid arthritis group inclusion criteria: * patients diagnosed with rheumatoid arthritis, * the ages of 18-65 years, * volunteer to participate in the study will be included in the study. exclusion criteria: * serious cardiopulmonary, neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions, * participated in a planned exercise program in the last three months, * cognitive impairment that will cause difficulty in understanding and following exercise test instructions, * contraindications to exercise testing or exercise training according to the american sports medicine association will not be included in the study. control group inclusion criteria: * the ages of 18-65 years, * volunteer to participate in the study will be included in the study. exclusion criteria: * diagnosed chronic or systemic disease, * regular exercise (physical activity) 3 days a week, 150 minutes/week of moderate intensity * smoking 10 packs x years or more, * pneumonia or any acute infection, * healthy individuals with any psychiatric disorder will not be included in the study.

Keywords: exercise capacity muscle oxygenation rheumatoid arthritis
motivational interviewing and self-care in type 1 diabetes: randomized controlled clinical trial.

Conditions: Type1diabetes

Summary: type 1 diabetes requires a high level of involvement of patients to obtain good control by following complex therapeutic recommendations. motivational interviewing has proven to be effective in changing behaviors in sedentary people, with addictions and with obesity. our objective is to evaluate the impact of an intervention with motivational interviewing in patients with type 1 diabetes, through a randomized controlled clinical trial. at least sixty patients with type 1 diabetes will be included with hba1c\> 8% that will be randomized with a ratio of 1: 1. in the intervention group, motivational interviewing will be applied in the routine clinical appointments with the endocrinologist, while the control group will receive the same visits but in a traditional way. the primary result will be self-care behaviors according to a validated questionnaire. secondary outcomes include: hba1c, number of hypoglycemia, motivation with self-care, self-efficacy, quality of life, compliance with patients' own objectives, lipid profile, weight and blood pressure. the professionals will be trained in motivational interviewing with the objective of favoring the adherence to self-care, the motivation of the patient and improving doctor-patient relationship. they will also be evaluated through a specific questionnaire.


Eligibility criteria:
inclusion criteria: * patients with dm1 seen in outpatient clinics of endocrinology and nutrition with at least one year of evolution, hba1c\> 8% and / or severe hypoglycemia in the previous 6 months exclusion criteria: * gestion underway or scheduled for the next 9 months. any circumstance that, in the opinion of the investigators, could interfere with the follow-up of the patient.

Keywords: self-care motivational interviewing doctor-pacient relationship
orphenadrine and methocarbamol for lbp

Conditions: Low Back Pain

Summary: low back pain is a common cause of visit to emergency department. it is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. this is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone

patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. participants will be followed by telephone one week and 3 months after the ed visit

Eligibility criteria:
inclusion criteria: * lbp duration \<= 2 weeks * no trauma to low back within previous month * no radicular symptoms * no history of low back pain or history of only infrequent episodes exclusion criteria: * medication allergies or contra-indications * not available for follow-up * chronic pain syndrome
a validation of the functional low-vision observer rated assessment (flora-20) for profoundly blind individuals

Conditions: Blindness, Acquired

Summary: this study aims to validate an observer-rated assessment titled "functional low-vision observer rated assessment (flora-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. this study shall be carried out with individuals who have an implanted visual prosthesis device. there are no new implantations or changes to the original implant or external wearables being studied or tested. additionally, data from the study shall not be used alter standard of care or the user's treatment options.


Eligibility criteria:
inclusion criteria: * subjects implanted with the argus ii or orion device * subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent * subject is able to follow instructions and comply with flora-20 scheduling and completion of tasks * subject is willing to be filmed while performing the flora-20 tasks during the study exclusion criteria: * subject is unsuitable for study participation as determined by investigator's clinical judgment (with sponsor's final input).

Keywords: observer-rated instrument
treatment patterns and bleeding risk of anticoagulants in patients with venous thromboembolism in korea

Conditions: Venous Thromboembolism

Summary: this study is a retrospective, observational, nationwide population-based cohort study utilizing the south korea's health insurance and review assessment service (hira) database. the aims of this study are to describe the sociodemographic and clinical characteristics of patients with venous thromboembolism according to their anticoagulant treatment (parenteral anticoagulants, warfarin, or non-vitamin k antagonist oral anticoagulants), to describe the treatment patterns related to anticoagulants, and to examine the risk of major bleeding according to the specific type of oral anticoagulants. the study will be conducted in two phases: phase i for descriptive study and phase ii for comparative study.


Eligibility criteria:
inclusion criteria: 1. incident vte diagnosis in an inpatient or outpatient setting between 1 mar 2013 and 30 jun 2019 2. received anticoagulation therapy (all medication codes for anticoagulants approved for vte in korea; ufh, lmwh, warfarin, and noacs) within 30 days of their vte diagnosis (the index date will be defined as the date of treatment initiation with anticoagulants) 3. aged ≥18 years at index date exclusion criteria: 1. had a record of vte diagnosis within the 12-month period prior to the index vte encounter. 2. diagnosed with atrial fibrillation/flutter, mechanical heart valve replacement or mitral stenosis anytime prior to index date 3. had a record of inferior vena cava filter anytime prior to index date 4. received anticoagulatory therapy within the 12-month period prior to index vte encounter 5. prescribed two different anticoagulants on the same index date 6. had a record of pregnancy within the 9-month period prior to index date 7. had a record of active cancer within the past 6 months of period prior to index date

Keywords: venous thromboembolism anticoagulant treatment pattern bleed
observational study of altus powered stapler used in bariatric surgery

Conditions: Obesity

Summary: post-marketing, observational study to evaluate the safety and performance of the altus powered stapler in bariatric surgery of "real-world" patients.

up to 300 patients who underwent sleeve, bypass or revisional bariatric surgery with the use of altus powered stapler will be included in the study. the stapler should be used according to the instructions for use and according to the local practice. the altus powered stapler is used in open or laparoscopic surgeries and simultaneously cuts and staples soft tissues. in order to avoid great physical efforts by the physician and ensure excellent tissue suturing, the cutting and stapling mechanism is driven by the 12-volt battery that comes with the stapler. patients will be followed by 7, 30 and 90 days and 12 months after the procedure, as per the research center's standard routine.

Eligibility criteria:
inclusion criteria: * patients with grade ii obesity (bmi ≥ 35 kg/m\^2) with one or more associated comorbidities; * patients with grade iii obesity (bmi ≥ 40 kg/m\^2) regardless of associated diseases; * patients who underwent sleeve, bypass and revisional bariatric surgery procedure with use of the altus powered stapler; * the patient must sign and date the informed consent form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up. exclusion criteria: * impossibility of collecting data related to the surgical procedure * impossibility of contact with the patient to obtain the informed consent form

Keywords: stapler altus bariatric surgery
multi-dose, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ddo-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.

Conditions: Anemia Associated Chronic Kidney Disease

Summary: the study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose ddo-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.


Eligibility criteria:
inclusion criteria: * patients with ckd anemia aged 18-70 years who were not on dialysis and were not expected to undergo dialysis during the study period, regardless of gender; * male weight≥50kg, female weight≥45kg, and 19kg/m2≤bmi\<28kg/m2; * signed informed consent. exclusion criteria: * allergic constitution, suspected to be allergic to the study drug or any component in the study drug; * patients with acute coronary syndrome, stroke, thromboembolism (such as deep vein thrombosis or pulmonary embolism) or a history of seizures within 6 months before screening; * patients with uncontroll ed hypertension; * new york heart association grade iii or iv congestive heart failure at the time of screening; * alt,ast or total bilirubin exceeds 1.5 times the upper limit of normal value (uln) during the screening period; * suffer from anemia other than ckd. * patients with a history of chronic liver disease; * patients with active bleeding or known coagulopathy; * patients who have any previous organ transplant or plan to perform organ transplant; * intravenous iron supplementation within 1 month before screening; * used erythropoiesis stimulator (esas), hypoxia-inducible factor-prolyl hydroxylase inhibitor (hif-phi), androgen, blood transfusion therapy within 3 months before screening; * hepatitis b surface antigen (hbsag), hepatitis c antibody (hcvab), syphilis antibody, and human immunodeficiency virus (hiv) antibody were positive; * patients with blood loss ≥400ml within 3 months before screening; * subjects who have taken other clinical trial drugs or are expected to have a legacy effect of the trial treatment; * participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;or male and female subjects who did not agree to use physical contraception during the trial; * patients who had a positive blood pregnancy test and were breastfeeding at the time of screening; * according to the study physician's judgment, there may be any other anemia factors that may exist, any possibility to increase the risk of the study, affect the subject's compliance with the protocol, or affect the physical or psychological disease or condition of the subject to complete the study.
study evaluating a novel ibuprofen formulation in the treatment of dental pain

Conditions: Pain

Summary: this study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.


Eligibility criteria:
inclusion criteria: * normal, healthy males and females 16 to 40 years of age * outpatients who have moderate to severe post-operative pain (confirmed by a visual analog scale-pain severity rating \[vas-psr\] score of at least 50 mm on a 100 mm vas psr) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction * use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide exclusion criteria: * pregnancy or breast-feeding * alcohol or substance abuse * any serious medical or psychiatric disorder * history of stomach ulcers, stomach bleed, or other bleeding disorders * use of a prescription or over-the-counter (otc) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (nsaid); acetaminophen (apap); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants \[including alcohol\])

Keywords: pain following third molar extraction (wisdom tooth)
convalescent plasma as potential therapy for severe covid-19 pneumonia

Conditions: Covid19 Pneumonia

Summary: to determinate feasibility, safety and outcome with convalescent plasma in patients with severe covid-19 penumonia

covid-19 convalescent plasma will be infused to patients with severe covid-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. data will be compared with match control arm patients without plasma infusion

Eligibility criteria:
inclusion criteria: * adult patients ≥18, and non-pregnant women * severe or critical covid-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 l/min, non-rebreathing mask (nro2-mask) or on noninvasive ventilation; and pulmonary infiltrates with \>50% increase within 24 to 48 hours in chest-x-ray or chest ct. life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with pao2 / fio2 less than 300 mm hg, septic shock, and/or multiple organ dysfunction. * 10 days from the onset of symptoms or ≤ 7 days on mechanical ventilation. - exclusion criteria: * more than 10 days from symptoms onset or more than 7 days on mechanical ventilation * pregnancy * contraindication for plasma infusion because anaphylaxis history * patients with high risk of circulatory overload * limitation of therapeutic efforts * refractory shock define by norepinephrine dose more than 1 ug/k/min * sofa score more than 15 points at the moment of the protocol inclusion i coagulopathy with requirements of plasma infusion