Kornimate/medical-research-clean huggingface dataset:
dose response effects of quillivant xr in children with adhd and autism: a pilot study

Conditions: ADHD; Autism

Summary: the purpose of this study is to determine whether quillivant xr is effective in the treatment of adhd in children with autism spectrum disorder (asd).

to evaluate the safety and tolerability of low to moderate dose effects of quillivant xr (liquid methylphenidate) and to observe changes in adhd symptoms and functional outcomes in children with asd and adhd. the investigators propose to investigate the low to moderate dose range of methylphenidate compared with a very low dose with a gradual dose escalation schedule because children with asd have been found to be more sensitive to the adverse effects of methylphenidate (especially in medium to high doses) than children without asd.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of autistic disorder or asperger's disorder by dsm-iv or autism spectrum disorder by dsm-v. * a dsm-v diagnosis of adhd based upon the k-sads-p. * clinical global impressions - severity for adhd (cgi-s-adhd) rating \> 4. * findings on physical exam, labs and ecg are judged to be normal for age with pulse and blood pressure within 95% of age and gender mean. * informed consent by a parent or legal guardian, and assent for children with developmental age 7 years or older. * at least one parent fluent in english exclusion criteria: * history of seizure disorder (febrile seizures are non-exclusionary). * history of intellectual disability (iq\< 70) * treatment with mao inhibitor (or within 14 days following discontinuation of mao inhibitor). * other psychotropic medication other than stable dose of selective serotonin reuptake inhibitors, which is permitted) * known to be hypersensitive to methylphenidate, or other components of quillivant xr * cardiac or other medical contraindications for stimulant trial (e.g., family history of heart attack at age younger than 40 years, personal history of heart disease, history of fainting while exercising, structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. if any doubt, children will be referred to a cardiologist for a cardiac clearance. * raynaud's disease * pregnancy or breast-feeding.

Keywords: quillivant
establishing a cohort for occupational disease of emergency medical workers

Conditions: Occupational Diseases; Emergency Departments

Summary: this study aims to understand the epidemiological characteristics, related factors , and current status of occupational diseases and damage that occur in emergency medical workers (doctors and nurses). a number of surveys were conducted on about 100 emergency medical workers for about a year with occupational factors, physical health, and mental health.

* background : 1. the importance and public role of emergency medical care * emergency medical care is a public and essential medical service that is directly related to the lives of the public and plays a key role in the domestic medical delivery system. 2. health problems of domestic emergency medical staff * emergency medical workers are at higher risk than the general population due to higher work intensity, lack of medical staff, unplanned patient occurrence, and congestion. * most emergency medical workers in korea are classified as high-risk medical staff and receive special medical checkups once or twice a year. on the other hand, these regular medical checkups are only an evaluation of the overall health status of medical staff, which does not lead to prevention before the deterioration of the health status of individual medical staff. * objective : the purpose of this study is to establish a cohort research system to develop prevention and health care solutions by identifying epidemiological characteristics, related factors for occupational diseases, and damage occurring in emergency medical workers (doctors and nurses). * design: observational (cohort study) * setting: in the department of emergency at the samsung medical center and other hospitals * enrollment : about 100 emergency medical workers (doctors and nurses) * methods: questionnaire surveys on occupational, mental, physical factors during about 1 year.

Eligibility criteria:
inclusion criteria: the emergency medical workers * who have heard the explanation of the study and agreed to participate * aged 18 or older * have no occupational disease or damage (within 4 weeks) at the time of cohort establishment. exclusion criteria: * those who disagree with this study * a person who is not engaged in actual work, such as taking leave of absence, or who does not agree to participate * those with occupational diseases or damage at the time of cohort establishment (within 4 weeks)
non surgical peri-implant mucositis treatment in patients with tissue-level and bone-level implants

Conditions: Peri-implant Mucositis

Summary: this study is designed to compare the resolution of inflammation of naturally-occurring peri-implant mucositis (pm) at tissue-level (tl) and bone-level (bl) implants after non-surgical mechanical debridement.

group a: peri-implant mucositis (pm) at tissue-level (tl) implants after non-surgical mechanical debridement. group b: peri-implant mucositis (pm) bone-level (bl) implants after non-surgical mechanical debridement.

Eligibility criteria:
inclusion criteria: * male and female aged \> 18 years * tl and bl titanium implants with smooth necks supporting cemented or screw-retained single-unit crowns diagnosed with pm (berglundh, et al.,2018) * implants placed in both arches * patients with gingivitis or treated periodontitis (i.e., absence of residual pd \> 5 mm) * presence of at least 2 mm of keratinized mucosa at implant sites. exclusion criteria: * presence of medical conditions contraindicating treatment of peri-implant mucositis, * regular use of anti-inflammatory drugs or antibiotics within 3 months prior to study enrollment * presence of systemic diseases * pregnant and lactating females * smokers \> 10 cigarettes/day * use of inflammatory drugs or antibiotics within 3 months prior to study recruitment * implants with modified (i.e. micro-rough) necks * interproximal open contacts between implant restoration and adjacent teeth * peri-implantitis (renvert, et al., 2018)
evaluation of menstrual irregularities and abnormal uterine bleeding after covid-19 vaccine

Conditions: COVID-19; Vaccine; Menstrual Irregularity; Menopausal Bleeding

Summary: covid-19 vaccines offered a good opportunity to counteract the spread of sars-cov-2 infection among the general population, reducing significantly both morbidity and mortality. nevertheless, after the first and second doses of vaccination (regardless of the type of vaccine used) several women required gynaecological visits claiming menstrual irregularities or abnormal uterine bleeding. considering this anecdotal evidence, a questionnaire was designed to investigate systematically whether menstrual irregularities or abnormal uterine bleeding occurred in a significant percentage of women undergoing first and second doses of covid-19 vaccination.


Eligibility criteria:
inclusion criteria: * women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used. exclusion criteria: * women undergoing any kind of hormonal therapy, including combined oral contraceptives, oral/vaginal progestins, intrauterine devices, gnrh-analogues, aromatase inhibitors, hormonal replacement therapy in menopause; * surgical menopause (hysterectomy and/or bilateral oophorectomy); * breastfeeding.

Keywords: covid-19 vaccine menstrual irregularity menopausal bleeding
validation of the mick assay

Conditions: Mesothelioma, Small Cell Lung Cancer, NSCLC

Summary: testing mayo clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.

this study will be conducted in two phases. during the feasibility phase, specimens from any tumor will be sent to the central diatech mick assay laboratory to determine the ease of sample acquisition, processing, transport, and assay interpretation. once diatech has completed analyses for the feasibility phase specimens and has confirmed that the sample acquisition, processing, transport, and assay interpretation are appropriate, we will proceed with the demonstration phase. during the mesothelioma demonstration phase, 20 mesothelioma samples will be assayed and the results will be correlated with prior patient therapy, performance status, and extent of disease.

Eligibility criteria:
inclusion criteria: * 20 subjects diagnosed with mesothelioma and 10 diagnosed with any malignancy. exclusion criteria: * patients that a sample cannot obtained for testing.
transmission of covid-19 during clubbing events in closed places

Conditions: Healthy Participant

Summary: the itoc study is a cluster randomised, controlled, multicentre trial in paris region, france. the intervention is an 8-hour indoor clubbing event with no mask wearing, no social distancing, at maximum room capacity. 1,200 healthy volunteers aged 18-49 years and fully vaccinated will be included. participants are recruited by group of up to 10, to be randomized 2:1 to experimental group (800 volunteers in a venue ) or control group (400 volunteers asked to stay at home). all participants will provide a salivary sample the day of experiment and seven days later. participants will also answer surveys on the social and psychological impact of lockdown and indoor club closing, attitude towards vaccination, behaviour at risk of covid-19 transmission during the day of the event (for both groups) as well as follow-up surveys on symptoms that participant may experience. virological analyses include polymerase chain reaction (pcr) of salivary samples and air of the venue, investigating sars-cov-2 pcr.


Eligibility criteria:
inclusion criteria: * aged between 18 and 49 years old * vaccination completed * people who declared to have no risk factor to severe form for covid-19 disease * people who declared not to live in the same place as someone with these risk factors * people residing in ile-de-france area * people affiliated with the the french social security citizen scheme exclusion criteria: * presence of symptoms of covid in the 2 weeks before the event * pregnant woman or woman who declares not having an effective contraception method * self identification of medical conditions or comorbidities identified as a proven risk of severe covid infection * people living with a person with these risk factors * confirmed diagnosis of sars-cov-2 within two weeks before the event * participants under tutorship or curatorship; * underage participants; * participants unable to give free and informed consent; * participants not affiliated to the french social security citizen scheme: obligation to join a social security scheme or be a beneficiary thereof. * participants under legal protection

Keywords: sars cov-2 transmission vaccinated night-club
vest prevention of early sudden death trial and vest registry

Conditions: Myocardial Infarction; Ventricular Dysfunction; Sudden Death; Ventricular Tachycardia; Ventricular Fibrillation

Summary: this study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.

in patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. wearable defibrillators may reduce sudden death by providing immediate detection and treatment of ventricular arrhythmias. this study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.

Eligibility criteria:
inclusion criteria: * patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute mi (stemi or non-stemi) * lv ejection fraction ≤35% determined at the following time point: 1. if no pci within the first 8 hours following the mi: ≥ 8 hours after mi 2. if acute pci occurs within 8 hours of mi: ≥8 hours after pci 3. if cabg is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post cabg * age ≥ 18 years exclusion criteria: * existing icd or indication for an icd at the time of screening * existing unipolar pacemakers/leads * chronic renal failure requiring hemodialysis after hospital discharge * chest circumference too small or too large for lifevest garment\* * participants discharged to an institutional setting with an anticipated stay \> 7 days * pregnancy * inability to consent * any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.

Keywords: myocardial infarction, acute myocardial infarction ventricular dysfunction death, sudden, cardiac death, sudden death ventricular tachycardia ventricular fibrillation defibrillation, electric cardioversion, electric electric countershock defibrillators, external
an interactive video educational tool improves the quality of bowel preparation for colonoscopy

Conditions: Colon Cancer Screening

Summary: the investigators aimed to determine whether an interactive, online educational platform could improve procedure show rates and bowel preparation scores in an outpatient population presenting for routine colonoscopy.

the investigators performed a prospective, endoscopist-blinded, randomized controlled trial at a hospital-based outpatient endoscopy center. eligible patients were randomized to two groups. both groups received verbal and written instructions per standard care, while the intervention group received access to an interactive, on-line video. primary outcomes were bowel preparation scores graded using the boston bowel prep score (bbps), procedure show rates, patient satisfaction, and pre-procedure anxiety. secondary outcomes included adenoma detection rate, mean bowel prep score per colonic segment, total number of polyps detected, and complication rates.

Eligibility criteria:
inclusion criteria: * english speaking * access to text messaging and the internet (mobile phone access alone was considered sufficient) * prescribed standard split-dose bowel preparation * able to provide informed consent via telephone. exclusion criteria: * pregnant * mentally impaired * undergoing screening or surveillance for inflammatory bowel disease .

Keywords: colonoscopy
endotoxin and intestinal flora before and after gastric bypass or banding in diabetics

Conditions: Obesity, Morbid; Diabetes Mellitus, Type 2; Gastric Bypass

Summary: this research project is designed to investigate endotoxin (a toxin present in the wall of certain kinds of bacteria) levels and the type of bacteria present in the intestine before and after roux-en-y gastric bypass or gastric banding surgery in patients that meet the classification for morbid obesity (body mass index \>40 kg/m2) and type 2 diabetes. it is known that the type of bacteria present in the intestines of normal weight and obese individuals are different, and it is also known that people with obesity and type 2 diabetes have higher levels of endotoxin. it has been shown that the bacteria change over the long run after roux-en-y gastric bypass surgery, but the short-term effects are not known and the endotoxin levels after this procedure have never been studied.

evidence exists that (i) morbidly obese, t2d patients undergoing rygb are highly likely to resolve t2d symptoms or dramatically reduce oral and/or insulin requirements, (ii) metabolic endotoxemia may incite the pathologic conditions of low-grade inflammation and subsequently insulin resistance, obesity and t2d, (iii) significant intestinal microbiologic flora differences exist between normal weight and obese/diabetic individuals, and (iv) rygb alters long-term intestinal microbiologic flora. therefore, it is logical to evaluate short- and long-term circulating endotoxin concentrations and intestinal microbiologic flora in context with weight loss and restoration of euglycemia to expand our knowledge of the mechanism of the benefits observed following rygb.

Eligibility criteria:
inclusion criteria: * age \> 18 years of age * morbid obesity (bmi \> 40 kg/m2) * confirmed t2d diagnosis/date of onset exclusion criteria: * age \< 18 years of age * bmi \< 40 kg/m2 * type 1 diabetes * chronic use of non-steroidal anti-inflammatory agents (nsaids) * chronic use of systemic corticosteroids * anticipated inability to maintain current statin, angiotensin converting enzyme inhibitor (acei), or angiotensin receptor blocking agent (arb) regimen

Keywords: type 2 diabetes mellitus gastric bypass gastric banding endotoxin
new therapeutic system of unruptured intracranial aneurysms based on big data from chinese population

Conditions: Unruptured Cerebral Aneurysm; Treatment Strategy

Summary: this is a prospective, multicenter, observational study, aiming at comparing the safety and effectiveness among the different surgical treatment of unruptured intracranial aneurysms in china, so as to improve the diagnosis and treatment of unruptured intracranial aneurysms.


Eligibility criteria:
inclusion criteria: * patients diagnosed with unruptured intracranial saccular aneurysm on cta, mra or dsa. * patients willing to participate in this clinical trial and attach to regular follow up. exclusion criteria: * intracranial aneurysm correlating to avm. * intracranial non-saccular aneurysm. * the rupture or unrpture of the aneurysm confirmed on cta、mra or dsa. * patients unwilling to participate in this clinical trial and attach to regular follow up.
treatment navigation for opioid use disorder

Conditions: Opioid-use Disorder

Summary: the investigators will conduct a pilot randomized controlled trial (rct) study of 100 people with a history of opioid use disorder releasing to wa department of corrections (doc) community corrections supervision in king county. half of the subjects will receive treatment as usual (e.g. referral to treatment or outpatient drug counseling by doc community corrections staff) and half will receive 6 months of intervention. the intervention involves treatment decision making, in which the study interventionists help subjects understand treatment choices, decide on the treatment that is best for them, get enrolled in treatment and remain in treatment. the study does not provide treatment, but works with treatment providers to facilitate access to care. the aims of this study are to determine: 1) whether study procedures can be implemented with as designed, 2) whether offenders can be enrolled and maintained in the study, 3) which medications/treatment options subjects select and their experiences and satisfaction with the interventions, and 4) preliminary intervention effect size on outcomes of interest including recidivism, drug use, hospitalization, and treatment enrollment and retention.


Eligibility criteria:
inclusion criteria: 1. meets diagnostic and statistical manual (dsm-5) criteria for opioid use disorder (at least 2 criteria) or were receiving treatment for opioid use disorder in the 12 months prior to incarceration. 2. released to community corrections, not currently incarcerated. 3. able to understand and provide informed consent. 4. has access to phone (voice or text) or email to communicate with research staff. exclusion criteria: 1. under age 18 or over age 70 at time of recruitment. 2. currently enrolled in an opioid treatment program using medications. 3. has not used opioids (prescription type or heroin) in the past 6 months prior to incarceration. 4. unwilling to allow access to medical or drug treatment records, criminal history or criminal activity records. 5. inability to communicate in english verbally. 6. inability to provide adequate contact information to assist with follow-up. 7. not planning on being in king county or reporting to community corrections in king county for 6 months. 8. violent or overtly hostile/threatening towards research staff. 9. entering a controlled environment for 31 days or more in the next 6 months.
clinical study of allo-asc-sheet in subjects with diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: this is a phase 2 double-blind clinical study to evaluate the efficacy and safety of allo-asc-sheet in subjects with diabetic foot ulcers, compared to placebo therapy.

1. active group: allo-asc-sheet 2. control group: hydrogel sheet (vehicle control) 3. study type: interventional 4. study design: randomized, comparator-controlled, double-blind, multi-center study.

Eligibility criteria:
inclusion criteria: 1. male or female subjects between 18 and 80 years of age. 2. diagnosed with type i or type ii diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit. 3. foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2. 4. ulcer graded i by wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule. 5. ulcer is free of necrotic debris, exhibits no signs of clinical infection. 6. ulcer area blood circulation meets one of the following criteria * a. blood vessels around the ulcer detected by doppler test * b. range of ankle brachial index(abi) was \> 0.7 to \< 1.3 * c. transcutaneous oxygen pressure, (tcpo2) \> 30 mmhg. 7. is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. ulcer is of non-diabetic pathophysiology. 2. the ulcer has increased or decreased in size by ≥ 30% during the week after the screening visit. 3. is human immunodeficiency virus (hiv) positive? 4. have severe hepatic deficiencies. 5. have a glycated hemoglobin a1c (hba1c) level of \> 10%. 6. have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue. 7. require intravenous (iv) antibiotics to treat the target wound infection. 8. have severe renal failure including subject on renal dialysis. 9. pregnant or breast-feeding. 10. is unwilling to use an "effective" method of contraception during the study. 11. have evidence of current infection including pus drainage from the wound site. 12. have a clinically relevant history of alcohol or drugs abuse. 13. have postprandial blood sugar \> 350 mg/dl. 14. is not able to understand the objective of this study or to comply with the study requirements. 15. is considered by the investigator to have a significant disease which might have impacted the study. 16. is considered not suitable for the study by investigator. 17. have a history of malignancy within the last five years (except basal cell carcinoam in situ). 18. is currently or were enrolled in another clinical study within 60 days of screening. 19. have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days. 20. is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening. 21. cannot maintain off-loading process 22. panel reactive antibody (pra) levels ≥ 20%