Kornimate/medical-research-clean huggingface dataset:
peer intervention to link overdose survivors to treatment (pilot)

Conditions: Opioid Overdose

Summary: the purpose of the peer intervention to link overdose survivors to treatment (pilot) study is to improve outcomes for individuals after surviving an overdose involving opioids. this study will be comparing the enhanced peer intervention known as pilot for overdose survivors with treatment as usual (tau) provided in the emergency department.


Eligibility criteria:
to be included in this study participants must: 1. be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion). 2. meet one of the following non-fatal overdose involving opioids (nfoo) criteria: 1. having presented to the emergency department for any health issue within the past 48 hours and self-report having a known or suspected overdose involving opioids in the past 72 hours, or 2. having presented to the emergency department within the past 48 hours for any sud-related health issue, self-report having a known or suspected overdose involving opioids in the past 30 days 3. be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant. 4. be able to speak english sufficiently to understand the study procedures and provide written informed consent to participate in the study as determined by research staff. 5. be willing and able to confirm future sud treatment receipt as evidenced by 2 out of 3 of the following: (a) signing appropriate releases to for study staff to confirm treatment with follow-up provider; (b) having technology necessary to visualize medication bottles and transmit to study team utilizing hipaa-compliant platform; and/or (c) able and willing to undergo toxicology tests (in person or via hipaa-compliant videoconferencing). exclusion criteria include those who are: 1. identified as having had an intentional overdose as the index nfoo. 2. actively suicidal at the time of screening (defined as current intention and/or plan for suicide attempt). 3. unable to complete study baseline procedures due to medical or psychiatric condition. 4. currently in jail, prison or in police custody at the time of the index ed visit or under current terms of civil commitment or guardianship (i.e., ohrp-defined prisoner status). 5. previously randomized as a participant in this study - individuals may only be enrolled and randomized once. 6. unwilling to follow study procedures (e.g., unable to provide sufficient locator information \[defined as two contacts\] or unavailable for follow-up assessments).

Keywords: overdose peer support
determining change in blood pressure due to environment and loudness

Conditions: Hypertension

Summary: determine the effects of environment and sound on initial and average triplicate screening blood pressure done according to clinical practice guidelines with an automated device. standardly obtained blood pressures obtained in a noisy, busy, public space will be higher than attended blood pressures obtained (1) in the same environment but with earplugs to minimize sound and (2) in a quiet, private space without surrounding activity.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years exclusion criteria: * hearing loss requiring hearing aids * presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, a-v shunts. * being mentally impaired * being pregnant * arm circumference exceeding 55 cm.
efficacy and safety of angong niuhuang wan for stroke

Conditions: Stroke (CVA) or TIA

Summary: to evaluate the efficacy and safety of using chinese medicine angong niuhuang wan in stroke patients, the modified rankin scale (mrs) score will be used as primary outcome, the national institutes of health stroke scale (nihss) score, the modified barthel index (mbi) score and the montreal cognitive assessment (moca) scores will be used as secondary outcome measures.

this study is a randomized, double-blind, placebo-controlled trial which is used to further determine the effectiveness of angong niuhuang wan in treating stroke patients on top of the standard conventional treatment, also to evaluate the improvement level on quality of life of post-stroke after using angong niuhuang wan. the effect of angong niuhuang wan on liver and kidney function will be focused and using nmr techniques to analysis metabolomics to further study the safety and effectiveness of angong niuhuang wan on the prevention and treatment of stroke. it is a 24-week trial, double-blind treatment for 1 week, follow up visit for 23 weeks. all participant will have study blood taking for renal and liver function test and questionnaires assessment during study visits. informed consent will be obtained before study enrollment.

Eligibility criteria:
inclusion criteria: 1. chinese adults aged 40 or above; 2. diagnosed as a stroke by a neurologist, with imaging of ct or mri support; 3. neurologist confirms the symptoms of stroke occur within 28 days and are clinically stable. in the past 48 hours, the condition of the nervous system has not deteriorated significantly; 4. tcm diagnosis is a stroke and belongs to a heat syndrome; 5. there is a movement defect caused by stroke; 6. the severity of stroke was scored 5-25 by the national institutes of health brain stroke scale (nihss); 7. informed consent will be given by participant or its representatives exclusion criteria: 1. the movement defects are not associated with stroke. before commencement of study treatment, patient has physical activity dysfunction caused by lameness , osteoarthritis, rheumatoid arthritis, gouty arthritis, etc. that may affect neurological function examination; 2. subjects are unlikely to come back for follow-up visits during the 24-week study period; 3. the subject has a brain tumor on a computed tomography scan (ct); 4. the subject has thrombocytopenia (known platelet count \<100,000 / mm3) or coagulopathy disease; 5. taking warfarin or other anticoagulant; 6. concomitant diseases such as severe hypertension or diabetes; 7. comorbidities or complications associated with drug evaluation; 8. pregnant or breast-feeding female. 9. the alanine aminotransferase (alt) value is 1.5 times higher than the normal maximum value in liver function test and the estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2 in the renal function test. 10. present the sign of pure yin syndrome or yin / yang defecation in tcm diagnosis; 11. subject has g6pd 12. known swallowing problem 13. dependent in all daily life activities
individualized infiximab dosing-proof of concept study

Conditions: Inflammatory Bowel Diseases

Summary: the purpose of this study is to determine which early infliximab pharmacokinetic level is most associated with clinical remission at weeks 30 and 54 in pediatric ibd patients.

our aims are: 1. to determine which early pk level; week 6 (peak), week 8 (2 week) or week 14 (trough), is most associated with week 30 and 54 outcomes in pediatric ibd patients. 2. to determine if the forecasted pk determined by a newly developed population pk model software program is in agreement with the observed pk in ibd patients receiving infliximab. subject recruitment is limited to patients of the principal investigator only. subjects will be approached for participation in the research in person during a routine clinic visit by a member of the study team.

Eligibility criteria:
inclusion criteria: 1. males and females on ifx 2. patients with ibd 3. age 6-23 4. able to obtain consent exclusion criteria: 1. not receiving infliximab 2. on 10 mg/kg of ifx 3. not able to obtain consent

Keywords: inflammatory bowel disease infliximab trough level crohn's disease ulcerative colitis
safety, tolerability, pk, and pharmacodynamics(pd) of ionis apociii-lrx in healthy volunteers with elevated triglycerides

Conditions: Elevated Triglycerides (TG)

Summary: the purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ionis apoc-iii-lrx given to healthy volunteer subjects.


Eligibility criteria:
inclusion criteria: * must have given written informed consent and be able to comply with all study requirements * healthy males or females aged 18-65 inclusive * females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal * males must be surgically sterile, abstinent or using an acceptable contraceptive method * bmi \< 35.0 kg/m2 * subjects must have fasting tg ≥ 90 mg/dl or ≥ 200 mg/dl depending on cohort assignment exclusion criteria: * known history of or positive test for human immunodeficiency virus (hiv), hepatitis c or chronic hepatitis b * treatment with another study drug, biological agent, or device within one-month of screening * regular excessive use of alcohol within 6 months of screening * use of concomitant drugs unless authorized by the sponsor medical monitor * smoking \> 10 cigarettes a day * considered unsuitable for inclusion by the principal investigator
p-wave duration and dispersion in intrahepatic cholestasis of pregnancy

Conditions: Intrahepatic Cholestasis of Pregnancy; Arrhythmia

Summary: the bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. bile acids may alter maternal cardiomyocyte function like fetus.increased p-wave duration and p-wave dispersion have been reported in various clinical settings. the investigators hypothesized that pwd and p wave duration may affect in pregnancy with icp.

intrahepatic cholestasis of pregnancy (icp) is a pregnancy-specific liver disease. the most frequent laboratory abnormality is elevation of serum bile acid levels in icp. bile acids increases both maternal and fetal circulation in icp. the bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. raised maternal bile acid levels have been associated with fetal distress and arrhytmia in fetus. p-wave dispersion (pwd) is defined as the difference between the maximum and the minimum p-wave durations measured on a 12-lead surface electrocardiogram (ecg). increased p-wave duration and pwd have been reported in various clinical settings, including atrial flutter, coronary artery disease, hypertension, rheumatic mitral stenosis, mitral annular calcification, obstructive sleep apnea, and obesity. so the investigators think that bile acids may alter maternal cardiomyocyte function as fetus. the investigators hypothesized that pwd and p wave duration may affect in pregnancy with icp. the aim of this study is to investigate maternal p-wave duration and dispersion changes in pregnant women with intrahepatic cholestasis of pregnancy .

Eligibility criteria:
inclusion criteria: - pregnants who with icp exclusion criteria: * chronic liver disease * disease during current pregnancy * multiple pregnancies

Keywords: cholestasis pregnancy p wave dispersion arrhythmia
benefits of an intervention combining hypnosis and self-care for prostate cancer patients

Conditions: Prostate Cancer

Summary: this study aims to assess the impact of a group intervention combining self-hypnosis and self-care techniques on prostate patients' well-being. more specifically, the investigators want to investigate the effects of that intervention on sleep, fatigue and emotional distress of the patients.


Eligibility criteria:
inclusion criteria: * 18-years-old, * ability to read, write and speak french * prostate cancer diagnosis * treatment with surgery and/or radiotherapy. exclusion criteria: * metastases * cancer recurrence at the moment of inclusion * major cognitive or psychiatric disorder.
innovative digital therapeutic for smoking cessation

Conditions: Smoking Cessation; Nicotine Addiction; Drug Addiction; Drug Dependence; Tobacco Dependence; Tobacco Use Disorder; Substance Use Disorder; Tobacco Smoking

Summary: this study is comparing the efficacy of two smoking cessation apps.

given that tobacco smoking is the leading cause of preventable death in the us, the development of effective cessation programs is critical; mobile phone applications represent a novel, accessible platform for helping smokers quit. this research project seeks to compare the efficacy of two smoking cessation apps. in a blinded, randomized, controlled study, current smokers motivated to quit will use a smoking cessation app for 8 weeks.

Eligibility criteria:
inclusion criteria: * male or female age 18 to 65 * fluent in written and spoken english (confirmed by ability to read and comprehend informed consent form) * lives in the united states * smokes at least 5 cigarettes daily * is interested in quitting in the next 30 days * the participant owns and has access to an iphone with ios 9 or greater capabilities, or an android with os 7 or greater capabilities * the participant is willing and able to receive sms text messages on their smartphone * the participant is willing and able to receive email messages. * ability to confirm download of installed treatment arm app via telephone on randomization date. * one half of the study sample will be recruited from the general population of smokers via social media advertisements * one half of the study sample will be recruited via mail form a magellan behavioral health value-based care network exclusion criteria: * prior use of treatment a digital intervention or treatment b digital intervention * current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (nrt)
phase ii study of postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma (eso- shanghai 17)

Conditions: Esophagus Cancer; Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Radiation Therapy; Postoperative

Summary: the purpose of this study is to evaluate safety and 2-year local control rate for postoperative concurrent chemoradiotherapy for esophageal squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: * joined the study voluntarily and signed informed consent form; * age 18-75; * ecog 0-2; * esophageal squamous cell carcinoma, radical surgery ≤ 3 months, r0 resection; * the operative incision healed well; * t3-4n0m0, t1-4n1-3m0 (according to ajcc2009); * no radiotherapy, chemotherapy or other treatments pre (post) surgery; * ps ecog 0-2; * life expectancy of more than 3 months; * hemoglobin (hb) ≥ 9 g/dl, wbc ≥ 3 x 109/l, neutrophils (anc ) ≥ 1.5 x 109/l, platelet count (pt) ≥ 100 x 109/l; * hepatic function: alat and asat \< 2.5 x uln, tbil\< 1.5 x uln; * renal function: creatinine \< 1.5 x uln * no immuno-deficiency; * use of an effective contraceptive for adults to prevent pregnancy. exclusion criteria: * complete esophageal obstruction after surgery, esophageal perforation, haematemesis; * other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years; * participation in other interventional clinical trials within 30 days; * pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives; * drug addiction, alcoholism or aids; * uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; * unsuitable to be enrolled in the trial in the opinion of the investigators.
an active comparator safety study evaluating the combination of apg777 + apg990 in moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (pk) parameters of the combination of apg777 + apg990 in adults with moderate-to-severe atopic dermatitis (ad), in comparison to dupilumab. the duration of the study will be approximately 82 weeks for each participant and will consist of a screening period (up to 6 weeks), treatment period (baseline-week 24), and follow-up period (week 28-week 76).

participants will be randomized to apg777 + apg990 or dupilumab in a 1:1 ratio. randomization will be stratified on day 1 according to baseline disease severity and geographic region.

Eligibility criteria:
inclusion criteria * have a diagnosis of ad that has been present for ≥ 1 year prior to the screening visit and as determined by the investigator through participant interview and/or review of the medical history. * moderate-to-severe ad at screening and baseline (day 1) visits, defined as: a) eczema area and severity index (easi) score of ≥ 16, b) viga-ad score of ≥ 3, and c) ad affecting ≥10% of body surface area (bsa). * history of inadequate response to treatment with topical medications * women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline (day 1) visit. exclusion criteria * participation in a prior study with apg777 or apg990. * prior treatment with protocol-specified monoclonal antibodies (mabs). * has used any ad-related topical medications within 7 days prior to baseline visit. * has used systemic treatments (other than biologics) and/or phototherapies and/or laser therapy that could affect ad within 4 weeks prior to baseline visit * history of known hypersensitivity to any of the ingredients in apg777, apg990, or dupilumab. * presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of ad and/or might interfere with study assessments note: additional protocol defined inclusion/exclusion criteria apply

Keywords: atopic dermatitis moderate-to-severe ad apg777 dupilumab apg990
how covid-19 virus outbreak affects antimicrobial resistance in a low-middle-income country's icu?

Conditions: Ventilator Associated Pneumonia

Summary: a previous study showed a high incidence of ventilator-associated pneumonia to multidrug resistant pathogens in our icu. that has been related to lack of compliance to hand hygiene among health care providers in ou icu.

a single-center cohort study performed in the department of anesthesia and intensive care in our hospital. all endotracheal isolates realised in the period of study are collected from the department of microbiology of our hospital.

Eligibility criteria:
inclusion criteria: * patients requiring mechanical ventilation for more than 24 hours exclusion criteria: -
a phase 3 trial of the safety, tolerability and efficacy of transcon hgh weekly versus daily hgh in children with growth hormone deficiency (ghd)

Conditions: Growth Hormone Deficiency, Pediatric; hGH (Human Growth Hormone); Endocrine System Diseases; Hormones; Pituitary Diseases

Summary: a 52 week trial of transcon hgh, a long-acting growth hormone product, versus human growth hormone therapy. transcon hgh will be given once-a-week, human growth hormone (hgh) will be given daily. approximately 150 prepubertal, hgh-treatment naïve children (males and females) with ghd will be included. randomization will occur in a 2:1 ratio (transcon hgh : genotropin). this is a global trial that will be conducted in armenia, australia, belarus, bulgaria, georgia, greece, italy, new zealand, poland, romania, russia, turkey, ukraine, and the united states.


Eligibility criteria:
inclusion criteria: * prepubertal children with ghd (either isolated or as part of a multiple pituitary hormone deficiency) in tanner stage 1 (tanner 1982) aged: * boys: 3-12 years, inclusive * girls: 3-11 years, inclusive * impaired height (ht) defined as at least 2.0 standard deviations (sd) below the mean height for chronological age and sex (ht sds ≤ -2.0) according to the 2000 cdc growth charts for the united states methods and development, available at http://www.cdc.gov/growthcharts/ * diagnosis of ghd confirmed by 2 different gh stimulation tests, defined as a peak gh level of ≤10 ng/ml, determined with a validated assay * bone age (ba) at least 6 months less than chronological age * baseline igf-1 level of at least 1 sd below the mean igf-1 level standardized for age and sex (igf-1 sds ≤-1) * written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is able to read, understand, and sign) exclusion criteria: * children with a body weight below 12 kg * prior exposure to recombinant hgh or igf-1 therapy * children with past or present intracranial tumor growth as confirmed by a sellar mri scan (with contrast) at screening (mri results from up to 6 months prior to screening may be accepted) * children with psychosocial dwarfism * children with idiopathic short stature * history or presence of malignant disease; any evidence of present tumor growth * closed epiphyses * major medical conditions and/or presence of contraindication to hgh treatment * participation in any other trial of an investigational agent within 3 months prior to screening

Keywords: human growth hormone hgh ghd rhgh pediatric growth hormone deficiency long acting growth hormone somatropin prodrug growth failure growth hormone replacement therapy sustained release sustained release growth hormone growth hormone deficiency
near infrared fluorescent imaging in thyroid and parathyroid surgery with the fluobeam(tm) system of fluoptics

Conditions: Primary Hyperparathyroidism

Summary: hypothesis: intraoperative use of near infrared fluorescent imaging technology and detection of methylene blue fluorescence will improve outcomes following thyroid and parathyroid surgery. aims: the aims of this phase of the study are to determine the feasibility of using near infrared fluorescent technology in the detection of parathyroid tissue and its differentiation from adjacent soft tissue during surgery on parathyroid glands. objectives of the phase i study: 1. to familiarise surgical teams with the intraoperative use of the 'fluobeam(tm)' device (fluoptics). 2. to understand the patterns (onset, intensity and duration) of fluorescent staining of normal parathyroid glands, thyroid glands and other soft tissue structures encountered during parathyroidectomy. further research: this will be followed by a phase ii study during which fluorescent imaging will be used in conjunction with intraoperative incremental dose of iv methylene blue in both thyroid and parathyroid surgery. phase ii will enable us to develop a protocol for the use of a minimum possible dose of mb for the identification of parathyroid glands. this will then be tested in the pilot phase of a randomized clinical trial.

as above

Eligibility criteria:
inclusion criteria: * all patients undergoing parathyroid surgery exclusion criteria: * patients undergoing re-do procedures * patients unable to give adequate informed consent * patients with a history of intolerance or sensitivity to mb * patients with g6pd deficiency * patients on serotonin reuptake inhibitors and patients undergoing thoracic exploration * either alone or in combination with a neck exploration.

Keywords: parathyroid surgery