Kornimate/medical-research-clean huggingface dataset:
study to evaluate safety and effects of tofacitinib and biologic disease modifying antirheumatic drugs in people treated for rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this is a secondary structured database observational study conducted in rheumatoid arthritis (ra) patients treated with biologic and nonbiologic dmards, including tofacitinib, collected as part of the corevitas japan ra registry. the data as of september 2022 will be used for this study. the study will include data from march 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.


Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis (ra) according to the 1987 american college of rheumatology (acr) or the acr/european lead against rheumatism (eular) 2010 ra classification criteria; * at least 18 years of age or older; * was / must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit: * csdmard: methotrexate (closed in february 2018); * anti-tnf bdmard: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-tnf biosimilar approved during the study; * non-tnf bdmard: abatacept, tocilizumab, sarilumab (closed in june 2020); * jak inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib. exclusion criteria: * data that are prior to march 2016 and after june 2022
buprenorphine in the emergency department

Conditions: Opioid Withdrawal; Opioid-use Disorder

Summary: this is a pilot randomized control trial randomizing patients presenting in opioid withdrawal to the emergency department to receive either one of clonidine (usual standard of care) or buprenorphine for their opioid withdrawal. primary treatment outcome is attendance at a rapid access addiction medicine clinic within a few days of emergency room presentation. secondary treatment outcome is treatment status with respect to opioid agonist treatment at one month post emergency room visit.


Eligibility criteria:
inclusion criteria: 1. presenting to the ed in opioid withdrawal or soon to be in withdrawal 2. minimum age 16 3. english speaking 4. active phone number 5. ontario health insurance program card exclusion criteria: 1. pregnant 2. currently enrolled in a methadone or buprenorphine maintenance 3. benzodiazepine addiction (or taking \>50mg of valium equivalent/day) 4. acute hepatitis or liver failure

Keywords: buprenorphine emergency department
impact of door-to-needle time on stroke outcomes at gonesse hospital

Conditions: Stroke; Ischemic Attack, Transient; Cerebral Infarction; Thrombolytic Therapy; Treatment Outcome

Summary: this study looks at how quickly stroke patients receive treatment after arriving at gonesse hospital and whether this affects their recovery. researchers will measure the time between a patient's arrival and the start of clot-busting treatment (called door-to-needle time), as well as the time from symptom onset to hospital arrival (home-time). the goal is to see if treatment delays impact recovery, and to find ways to improve stroke care in the hospital.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * confirmed diagnosis of acute ischemic stroke on imaging * initial acute stroke care provided at gonesse hospital during the study period (3 months) * intravenous thrombolysis (r-tpa) initiated at the hospital * availability of clinical and timing data to calculate door-to-needle time (dnt) exclusion criteria: * patients with hemorrhagic stroke or subarachnoid hemorrhage (sah) * thrombolysis initiated before hospital arrival * missing, incomplete, or unusable timing data for dnt calculation
effectiveness and acceptability of moodgym in treating depressive symptoms in chinese americans

Conditions: Major Depressive Disorder

Summary: this study aims to evaluate efficacy and acceptability of the chinese language version of moodgym as a therapeutic intervention in treating symptoms of depression in community dwelling chinese americans in the boston area. hypothesis 1: participants enrolled in moodgym will show a significant decrease in depressive symptoms after completion of the 5 modules. hypothesis 2: participants enrolled in moodgym will show significantly improved dysfunctional thinking. hypothesis 3: participants enrolled in moodgym will rate this program as culturally acceptable.


Eligibility criteria:
inclusion criteria: * resident of the us, but self-identified as chinese origin * at least 18 years of age * proficiency in chinese, including the ability to read chinese * access to computer and internet * scores \> 10 on the chinese bilingual patient health questionnaire -9 item (phq-9) exclusion criteria: * current ongoing psychiatric or psychological treatment * using illicit drugs or consumption \> 3 standard drinks in a day * currently experiencing a psychotic illness * past or current history of schizophrenia or bipolar disorder * ect during the last year * current active suicidal or self-injurious potential necessitating immediate face-to-face treatment

Keywords: major depressive disorder cognitive behavioral therapy computerized cbt online cbt
assessment of adverse cardiac events using local anesthesia with adrenaline

Conditions: Arrythmia

Summary: the use of vasopressor supplement materials to local anesthetics is commonly used in procedures in various fields of dentistry, ent (ear, nose, and throat), plastic surgery, hand surgery and gastroenterology. epinephrine is used to constrict small blood vessels, thus reducing bleeding during a medical procedure, reducing the toxicity by reducing systemic absorption of local anesthetic, and prolonging the duration and intensity of neural blockage created by the local anesthetic. there are descriptions in the literature of cases in which the use of lidocain and adrenaline caused adverse cardiac events such as arrhythmias, edema and increase in blood pressure during ent and dentistry procedures. as far as we know there has never been a systematic examination of the incidence and severity of arrhythmias during procedures with local anesthesia. the purpose of the study: 1. to examine the prevalence and types of arrhythmias in patients undergoing a medical procedure performed under local anesthesia 2. examine whether adding adrenaline to the local anesthetics affects the incidence of arrhythmia determining the prevalence and types of arrhythmia will help determine the need for monitoring and type of monitoring required during procedures under local anesthesia. the patients: 500 patients undergoing surgery or a medical procedure in which a local anesthetic is used at meir hospital. patients with a medical history of known cardiac arrhythmia will not be included. methods: patients will undergo the medical procedure prescribed for them, using local anesthesia with or without adrenaline, at the discretion of the surgeon, in accordance with the usual routine being applied nowadays. the amount and type of anesthesia used will be registered. in addition to the routine monitoring that is currently performed (blood pressure cuff and non-invasive blood oxygen saturation) a continuous ecg monitoring device will be connected prior to the beginning of the surgical procedure, until the patient is discharged from the recovery room. the ecg monitoring results will be analyzed to detect arrhythmia. side effects being reported by patients (palpitations, dizziness, fainting, cpr {cardiopulmonary resuscitation} ) will be recorded. in cases that an arrhythmia is detected, the type of arrhythmia and the presence of clinical symptoms will be investigated.


Eligibility criteria:
inclusion criteria: * patients undergoing surgery or a medical procedure in which a local anesthetic is used at meir hospital. exclusion criteria: * patients with a medical history of known cardiac arrhythmia will not be included.
evaluate the safety of depakote extended release tablets in the treatment of mania associated with bipolar disorder in children and adolescents

Conditions: Bipolar I Disorder, Manic or Mixed

Summary: to determine if long-term treatment, up to 6 months, with depakote er is safe and effective in the treatment of bipolar i disorder in children and adolescents.


Eligibility criteria:
inclusion criteria: * subject and subject's legal representative have voluntarily signed and dated an irb-approved informed assent form and an irb-approved informed consent form, respectively, before any study-specific procedures or tests are performed. * the subject was randomized into study m01-342 and either completed the study or prematurely discontinued due to ineffectiveness. * the subject is male or a non-pregnant, non-lactating female. * subject is judged to be in general good health based upon the results of a physical examination, vital signs, 12-lead electrocardiogram (ecg), and laboratory profile (as described in section 5.3.1) exclusion criteria * subject is female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives). * subject experienced a serious adverse event in study m01-342, which the investigator considered "possibly" or "probably related" to study drug. * subject is violent, homicidal, or suicidal such that, in the opinion of the investigator, the subject is at significant imminent risk of hurting self or others. * subject has any of the following abnormal laboratory results at the last assessment prior to day 1: platelet count \ /= 2 times upper limit of normal (uln) * the subject is taking a protocol allowed medication for adhd that has not been stable for at least 3 months prior to day 1, is expected to require a dosage adjustment during the study, or that, in the investigators opinion, may be exacerbating mood symptoms. * subject requires treatment with or has taken a protocol-prohibited medication (see appendix d) within 5 elimination half lives of day 1. * subject has received an investigational drug, other than depakote er in study m01-342, within 30 days prior to day 1 of this study. * in the investigator's opinion, long-term treatment with depakote er for the subject's mania associated with bipolar disorder is contraindicated. * for any reason, subject is considered by the investigator to be an unsuitable candidate for this study.

Keywords: bipolar i disorder depakote er divalproex sodium
phase i study in china - tolerability of a single dose of abatacept 30 mg/kg

Conditions: Lupus Nephritis

Summary: the purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland chinese subjects with systemic lupus erythematosus (sle)


Eligibility criteria:
inclusion criteria: * men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (sle) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis * stable renal disease * no flaring of other organ systems in a minimum of the last 3 months exclusion criteria: * unstable lupus nephritis and serum creatinine \>3 mg/dl * progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis * severe unstable, refractory, or progressive sle * history of cancer * participants at risk for tuberculosis * autoimmune disease other than sle as main diagnosis * human immunodeficiency virus or herpes zoster infection * hepatitis-b surface antigen-positive or hepatitis c antibody-positive participants
ct pancreas perfusion

Conditions: Pancreatic Ductal Adenocarcinoma; Chronic Pancreatitis; Autoimmune Pancreatitis

Summary: 1. pancreatic ct perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis. 2. pancreatic ct perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use). 3. pancreatic ct perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.


Eligibility criteria:
inclusion criteria: 1. a. suspected pancreatic adenocarcinoma, age 35 to 99 years. 2. a. chronic pancreatitis with chronic pain, age 18 to 99 years. must be a confirmed diagnosis by either ct, endoscopic ultrasound (eus), or endoscopic retrograde cholangiopancreatography (ercp). 2b. to undergo endoscopic or surgical decompression with 0 to 10 days of first study visit ct perfusion scan. 2c. to answer pain questionnaire before first ct perfusion scan. 2d. to return within three weeks to three months after decompression treatment for another ct perfusion scan and complete the second pain questionnaire. 3a. autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by ct, mri, or eus or 3b. irregular narrowing of the pancreatic duct on ercp and either elevated serum immunoglobulin g4 (igg4), or histological confirmation. exclusion criteria: 1a. pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion. 1. b. pancreatic ductal adenocarcinoma tumors less than 2 cm in size. 2. a. chronic pancreatitis with diffuse and extensive pancreatic calcification. 3. a. autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis . any cohort: 4. pregnant. 5. prior iodine contrast reactions. 6. iodine allergy. 7. decreased kidney function being a serum creatinine greater than 1.5mg/dl. 8. any contraindication to having a ct scan with iodine contrast.

Keywords: inflammation pancreas chronic pancreatitis alcoholic pancreatitis carcinoma, pancreatic ductal pancreatic neoplasms
effects of stress and drug-cue exposure (scm)

Conditions: Marijuana Abuse

Summary: the purpose of the proposed study to examine the links among stress, craving for marijuana, and marijuana reminders, or "cues". in this study, an agent called yohimbine will be used to produce stress-like responses. yohimbine is known to cause stress response in studies of alcohol and other substance use disorders. this study intends to show it can be used to cause stress in marijuana users as well.

part of this study will be conducted on a residential unit where participants will live for 7 nights over a 2-week period (4 consecutive nights the 1st week and 3 consecutive nights the 2nd week). during that time, participants can't leave the unit unescorted or have visitors. during the inpatient stay participants will participant in experimental sessions where they will be asked to smoke cigarettes containing either marijuana or placebo (a blank). participants will be asked to take capsules that could contain yohimbine or placebo (blank). participants will be asked to complete questionnaires and will have their vital signs (blood pressure, heart rate) monitored throughout each session. participants will be asked to participate in overnight sleep recordings, a polysomnogram (psg).

Eligibility criteria:
inclusion criteria: * participants (18-55 yr) will be current marijuana users, based on self-report and thc-positive urine samples. * candidates must meet dsm-5 criteria for mild-to-moderate cannabis use disorder (cud) and be willing to participate in research but not seeking treatment. * candidates must be in good health, as assessed using data from psychiatric evaluation, extensive substance use history interview, and medical evaluations including medical history, physical exam, standard lab tests and 12-lead ecg. exclusion criteria: candidates with the following conditions will be excluded: * serious psychiatric illness (e.g. psychotic or bipolar disorder, recent suicide attempts, major depression). * substance use disorders other than cannabis or nicotine use disorders and mild alcohol use disorder. * neurological diseases * cardiovascular problems (e.g. including systolic bp \>140 or \ 90 mmhg, abnormal ecg). * pulmonary diseases * systemic diseases * cognitive impairment (\<80 iq) * past-month medications that increase study risk. * women who are pregnant, lactating, or if heterosexually active and not using medically approved birth control. * candidates seeking substance use disorder treatment. * individuals unable to give voluntary informed consent will be excluded.
the influence of central and peripheral fatigue on sports performance and prevention of sports injury

Conditions: Fatigue

Summary: this is an observational study that assess the baseball pitchers' fatigue status. the purpose of this study is to find the pitching mechanic change and the fatigue point to provide guidance for coaches to schedule training items . it is expected that earlier detect the pitchers' fatigue point could be able to prevent overuse injury caused by compensatory actions.

the expected outcomes of this study include providing more reliable scientific evidence of the effects of fatigue on baseball players' performance and movement control, which can help to improve muscle endurance and the quality of movement control. moreover, fatigue that resulted from the prolonged practice can be reduced and recovered faster after exercise, as well as more understanding on the ideal pitching posture and compensatory action that caused by fatigue, providing a guideline for exercise training. this will not only help to prevent fatigue and reduce risk of injury, but also strengthen weak muscle groups and improve movement strategies before matches, as well as lengthen the time of being a baseball player.

Eligibility criteria:
inclusion criteria: * healthy baseball pitchers * age between 18\~35 years old exclusion criteria: * surgery history in pitching arm * musculoskeletal disease * neuromuscular disease
dementia symptom management at home program

Conditions: Dementia

Summary: alzheimer's disease and related disorders (dementia) poses a significant challenge to our public health. while many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare, most home healthcare clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. this study will therefore utilize a cluster randomized controlled design at 3 study sites to examine the ability of a multi-component evidence-based practice primary palliative care quality improvement program for home healthcare registered nurses, occupational therapists and physical therapists to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.


Eligibility criteria:
inclusion criteria: * pwd over the age of 65 * admitted to one of the three hhc agencies * the patient and family caregiver speak english and/or spanish. * the informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient. * patients who score ≥6 on the quick dementia rating scale (at least mild impairment). exclusion criteria: * patients with a separate axis 1 diagnosis other than forms of dementia, depression or anxiety. * pwd residing in assisted living facilities or board and care homes * pwd solely receiving infusion or home health aide services.
plant sterols effect on previous statin therapy

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the effect of plant sterols associated with ezetimibe in ldl-cholesterol levels in coronary patients previously on statin therapy

background: consumption of food products enriched with plant sterols and treatment with ezetimibe both reduce cholesterol absorption in the intestine by different mechanisms and effectively reduce ldl cholesterol (ldl-c) plasma levels. although, the associated usage of ezetimibe to plants sterols in coronary patients not reaching recommended lipid levels despite the use of statins has not yet been demonstrated. objectives: evaluate if ezetimibe 10mg associated to plant sterols spread enriched with 2g of plant sterols in coronary patients not reaching recommended lipid levels despite the use of statins is able to reduce cholesterol levels after 6 week treatment. methods: prospective, open-label study with both male and female patients with stable coronary disease and ldl \> 70mg/dl. patients will be randomized for the following 6 week treatment: control group (ct) no additional statin therapy, ezetimibe group (ez) 10 mg/day ezetimibe, plant sterol group (ps) spread enriched with 2g of plant sterols or ezetimibe+plant sterols group (ez+ps) 10mg/day ez + 2g ps. anthropometric evaluations and laboratory exams (blood glucose test, total cholesterol, ldl-c, hdl-c, triglycerides, and c-reactive protein) will be performed in all groups at baseline and after the sixth week intervention.

Eligibility criteria:
inclusion criteria: * patients with previous myocardial infarction, stroke or coronary angiography demonstrating significant coronary disease. * subjects under statin treatment with a fixed dosage for the previous three months before randomization, and did not reached ldl less than 70mg/dl. exclusion criteria: * subjects already taking ezetimibe and/or plant sterols * younger than 18 years * presence of any contraindication to statin * pregnant women or breast-feeding women or * patients with previous history of statin hypersensibility

Keywords: ezetimibe plant sterol hydroxymethylglutaryl coenzyme a reductase inhibitors coronary artery disease ldl-cholesterol