Kornimate/medical-research-clean huggingface dataset:
desk cycling work performance evaluation

Conditions: Obesity; Physical Activity; Overweight

Summary: this lab study is evaluating the feasibility of accomplishing productive office work while simultaneously pedaling a compact desk-based cycling device.


Eligibility criteria:
inclusion criteria: * 18-65 years * ability to type without looking at the keyboard * native english speaker * normal hearing * spend 6 or more hours per day sitting * less than 150 minutes of physical activity per week exclusion criteria: * positive response on the physical activity readiness questionnaire indicating that low intensity pedaling could present safety risks * pregnancy * body mass index less than 18 or greater than 35
pharmacogenetic variation: factors that may affect the efficacy and safety of medical marijuana

Conditions: New York Medical Marijuana Program Qualifying Conditions

Summary: the primary purpose of this research is to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. the pharmacogenomics test detects dna variants, which may affect the way drugs work and are metabolized in the body and/or detect potential side effects.

this observational, population-based study will examine genetic differences between ultra-rapid, intermediate and poor metabolizers of various formulations of columbia care's medical cannabis products in order to identify genetic factors that may affect the efficacy and safety of medical marijuana, regardless of condition. the goal of the research is to establish relationships between cannabis consumers, cannabinoids, and consumer outcomes. the study is expected to enroll 150 subjects across three cohorts, high daily dose users (poor metabolizers) that take more than 50 mg of cannabinoids daily (n=50), low daily dose users (ultra-rapid metabolizers) that take less than 10 mg of cannabinoids daily (n=50), and a control group (intermediate metabolizers) that represents the median daily dose user taking between 11-21 mg of cannabinoids daily (n=50). columbia care inc. has identified trends amongst its medical cannabis users suggesting that there are some patients who are "high daily dose users" and others who are "low daily dose users", with both groups assumed to have similar satisfaction with the products. the complexity of the endocannabinoid system combined with individual genetic predisposition and gene-environment interactions likely result in the variation in response seen with cannabinoid treatment.

Eligibility criteria:
inclusion criteria: * males and females age 18 and older * currently obtaining medical marijuana products from columbia care llc * willing to participate and consent to a dna analysis * purchased product from columbia care for three consecutive encounters spanning a 6-month period exclusion criteria: * unwillingness to participate and consent to a dna analysis * unwillingness to answer a survey/questionnaire on patient satisfaction as related to product efficacy

Keywords: medical cannabis medical marijuana
using serious games to improve social skills in autism

Conditions: Autism Spectrum Disorder; Autism

Summary: the investigators will conduct a small-scale randomized control trial comparing the intervention game to an active control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). these outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to uncontrolled, real-world social interactions between dyads.

the investigators will conduct a small-scale randomized control trial comparing the intervention game to an placebo control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). these outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to real-world social interactions between dyads. the aims are evaluating 1) changes in the target mechanisms (social attention to faces, sensitivity to eye gaze cues) for the intervention relative to active control group, 2) engagement of intermediate mechanisms, including face-processing behaviors and real-world social communication behaviors, and 3) the relation between engagement of the target and intermediate mechanisms and symptom outcomes. evidence of changes in autism social symptoms resulting from changing visual attention to faces and/or improved ability to understand eye gaze cues will provide clear evidence to inform a "go" decision about the therapeutic target for further clinical development.

Eligibility criteria:
inclusion criteria: 1. parent/caregiver of an adolescent with a diagnosis of autism spectrum disorder (asd), 2. parent/caregiver and adolescent with asd both native english speakers, 3. adolescent with asd aged between 10-18 years at pre-test, 4. adolescent has normal vision and hearing with correction as reported by caregiver, 5. adolescent is able to use a computer for the purposes of game play, 6. adolescent scores \< 80% correct (i.e., 0.5 sd less than mean of typically developing adolescents) on online eye gaze screening task, 7. asd diagnosis of adolescent confirmed via parent-report scq and clinical interview with adolescent to assess dsm-v criteria (borderline cases also undergo adi interview); 8. full scale iq of adolescent determined to be between 70-130; 9. reading ability of adolescent determined to be at least a 2nd grade level; 10. adolescent is capable of cooperating with testing; 11. parent/caregiver and adolescent both consent/assent to participate in the research. exclusion criteria: 1. having seizures within the previous two years 2. no stable internet connection in the home 3. refusing to consent/assent to take part in the research 4. 18 and have a legal guardian, which prohibits them from legally consenting for themselves 5. 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.

Keywords: adolescent face social skills video game
indigenous recovery planning for american indians

Conditions: Alcohol Use Disorder; Substance Use Disorders

Summary: this research project uses a community-based participatory research (cbpr) framework to test the efficacy of a culturally adapted relapse prevention intervention developed collaboratively by community partners from the fort peck indian reservation in northeastern montana and research partners from montana state university. the indigenous recovery planning intervention employs trained fort peck community members to deliver manualized intervention content to american indian adults with substance use disorder (sud). by increasing access to culturally responsive evidence-based treatment, this research aims to decrease sud-related health disparities and improve public health outcomes for underserved native communities locally and nationally.


Eligibility criteria:
inclusion criteria: * american indian, 18 years of age or older, living on the fort peck reservation, meeting diagnostic criteria for substance use disorder, wanting treatment/help with recovery. exclusion criteria: * not meeting inclusion criteria.
examining the genetic predictors of coronary artery calcification in african americans

Conditions: Atherosclerosis

Summary: coronary artery disease (cad) is an important health concern for african americans, who are diagnosed with cad at high rates. coronary artery calcification, which is characterized by calcium deposits in the coronary arteries, is a contributing factor to cad. this study will examine the possible genetic causes of coronary artery calcification in african americans.

in the united states, more people die from cad than any other disease, with african americans, particularly women and young men, being more affected by cad than european americans. one cause of cad is atherosclerosis, a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries. coronary artery calcification occurs as a result of atherosclerosis and is characterized by calcium build up in the arteries. non-invasive imaging, including computed tomography (ct) scans, of coronary artery calcification is an effective way to assess cad risk. the genetic epidemiology network of arteriopathy (genoa) study, which is part of the family blood pressure program (fbpp), is a study that examined siblings with high blood pressure during two exams conducted between 1995 and 2004. the purpose of this new genoa study, which will enroll past genoa participants, is to identify genetic factors that may lead to the development of coronary artery calcification in african americans. conducting genetic studies in the african american population will result in greater understanding of the mechanisms of atherosclerosis, and may lead to improved strategies for the early identification of people at risk for cad and the development of new treatments for cad. this study will enroll people who have participated in the second genoa exam and who live in jackson, mississippi. participants will attend one study visit at the university of mississippi medical center. during the study visit, participants will be interviewed by study staff about their medical and family health history; health behaviors; physical activity levels; and use of tobacco, alcohol, and medications. they will complete a walking activity and tasks to assess memory, thinking speed, and accuracy. participants will also complete a questionnaire about their mood, a physical examination, a ct scan of the heart, and a blood collection. a portion of blood will be stored for future research studies.

Eligibility criteria:
inclusion criteria: * participated in the second genoa exam in jackson, mississippi and is alive and willing to participate exclusion criteria: * reported a history of heart attack, stroke, or coronary or non-coronary heart surgery

Keywords: coronary artery calcification
monotherapy with letrozole in tubal pregnancy

Conditions: Tubal Pregnancy Unruptured

Summary: it is hypothesized that the inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. treatment of tubal pregnancy with letrozole would allow to avoid the adverse effects of methotrexate (mtx) in women refusing surgery. the aim was to compare the effectiveness of letrozole with mtx in the management of tubal pregnancy.

a prospective cohort study is conducted among women with tubal pregnancy. women with increasing b-human chorionic gonadotropin (b-hcg) concentrations are included. two study arms were planned: i) women treated with mtx: mtx in a single dose of 100 mg intravenously on day 0; ii) women treated with letrozole: letrozole at a daily dose of 5 mg orally for 10 days from day 0. the inclusion criteria included b-hcg concentration up to 3000 miu/ml and no contraindications to conservative treatment. women who did not meet criteria for conservative treatment were excluded. blood parameters (b-hcg, hemoglobin, creatinine, urea, alanine/aspartate transaminase, gamma-glutamyltransferase, bilirubin) were tested on days 0,4,7. cases of treatment failure were counted, i.e. the need to perform laparoscopy due to tubal pregnancy rupture, pain, increase in b-hcg concentration. the women were given the option to choose the treatment used in the study. all enrolled women gave informed written consent to participate in the study.

Eligibility criteria:
inclusion criteria: * tubal pregnancy confirmed on pelvic ultrasound * increasing serum b-hcg concentrations in at least two subsequent measures * serum b-hcg concentration ≤ 3000 miu/ml exclusion criteria: * free fluid in lesser pelvis on pelvic ultrasound * positive fetal heartbeat on pelvic ultrasound * abdominal pain * heterotopic pregnancy * contraindications to mtx

Keywords: tubal pregnancy methotrexate letrozole
niv nava versus niv-ps in pediatric patients - pilot study

Conditions: Acute Respiratory Failure

Summary: this pilot study will be an observational no randomize study in which the ninavaped protocol will be applied solely to the niv nava arm.

this pilot study will be an observational no randomize study in which the ninavaped protocol will be applied solely to the niv nava arm. every picu will have to include 3 patients in the pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients. should the pilot study reveal deficiencies in the ninavaped design, the protocol would be improved accordingly. there will be a specific consent document during the pilot study. the pilot study will be published in a scientific journal.

Eligibility criteria:
inclusion criteria: * age: \> 1 month age to 18 years * moderate/severe pediatric acute respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (eti). * non intubated * admitted to the picu * minimally agitated/sedated: between -2 and +2 on the richmond agitation-sedation scale (table 2) exclusion criteria: 1. patients younger than 1 month or older than 18 year 2. patients who need immediate endotracheal intubation: i.e.: severe arf with signs of exhaustion 3. facial trauma/burns 4. recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding 5. fixed obstruction of the upper airway 6. inability to protect airway 7. life threatening hypoxemia defined as spao2 \ 0.8 on hi-flow oxygen. 8. hemodynamic instability: refractory at volume expansion \>60 ml/kg and dopamine \>10 mcg/kg/min 9. impaired consciousness defined as glasgow coma scale \< 10. 10. bowel obstruction. 11. untreated pneumothorax. 12. poor short term prognosis (high risk of death in the next 3 months) 13. known esophageal problem (hiatal hernia, esophageal varicosities) 14. active upper gastro-intestinal bleeding or any other contraindication to the insertion of a ng tube. 15. neuromuscular disease 16. vomiting 17. cough or gag reflex impairment. 18. cyanotic congenital heart disease. 19. complete absence of cooperation 20. this patient has been included (randomized) previously in the study

Keywords: neurally adjusted ventilatory assist pediatric acute respiratory failure non-invasive ventilation
partnership on nutrition and hiv/aids research in tanzania: exploratory research study on selenium and hiv infection

Conditions: HIV Infections; Pregnancy Complications

Summary: the purpose of this study is to determine whether the oral administration of daily selenium supplements to hiv-1 positive pregnant women: enhances immune status and reduces the hiv-1 viral load at six months postpartum, reduces the risk of lower genital shedding of hiv-1 infected cells at 36 weeks of gestation, and reduces the risk of mastitis at six weeks postpartum, compared to placebo.

we are recruiting pregnant women who are infected with hiv and assign them to receive selenium or placebo. all women will be given standard prenatal care, including nevirapine for the prevention of mother-to-child transmission and prenatal multivitamin supplements. we will examine the effect of the selenium supplements on intermediate outcomes predictive of the risks of transmission of hiv and to disease progression.

Eligibility criteria:
inclusion criteria: * hiv-1 infected women between 12 and 27 weeks of gestation exclusion criteria: * women with clinical aids defined according to who criteria

Keywords: hiv selenium nutrition women pregnancy tanzania maternal and child health outcomes hiv/aids pregnancy outcome
olfactory and taste changes during fasting mimicking diet (fmd)

Conditions: Diet, Healthy; Obesity; Olfaction Disorders

Summary: literature experiences demonstrated the impact of medically-assisted pulsed fasting on olfactory behavior in both the animal and human models and - conversely - the lack of homogeneous results linked - up to now - to administrations of pulsed fasting which are not widely codified. thus, objective of this study protocol is to evaluate the olfactory-gustatory aspects and blood patterns of a group of subjects suffering from obesity / overweight after a 6-month period of fasting mimicking diet (fmd) (group a) - consisting of a caloric restriction regimen - compared to a group of homogeneous subjects observing their own eating habits (group b) which - according to a "cross-over" model - will undergo fmd in the following semester during which the subjects belonging to group a will observe their eating habits.

a group of obese and/or overweighted patients who did not pass screening criteria (bmi andor neuropsychological testing) to undergo surgical procedure aimed at reducing weight (grastrectomy, bypass, other...) will follow a 6-month period of fmd followed by 6-month period of routinary eating behaviour (group a) or viceversa (group b). all the patients will undergo - before and after the administration of fmd or the routinary diet habit - a battery of: * olfactory test (sniffin' stick test) * taste test (taste strips) * blood samples including: igf-1, igfbp1/3, vegf, insulin, adiponectin, c reactive protein, plasma ghrelin, serum glucose, alanine aminotransferase (alt) and aspartate aminotransferase (ast), total cholesterol, triglycerides (tgs), high density lipoprotein (hdl) cholesterol and low-density lipoprotein (ldl) cholesterol, erythrocyte sedimentation rate (esr), conjugated and unconjugated bilirubin, uraemia, serum creatinine and leptin. * anthropometeric measures, including height and body weight, bmi, waist circumference (wc), estimation of fat mass (fm, in % and kg), skeletal muscle mass (mm, in % and kg) and grade of visceral fat (vf level)

Eligibility criteria:
inclusion criteria: * subjects excluded from bariatric surgical treatment for failing to neuropsychological tests or for co-morbidities that would excessively increase the intra-operative and/or * non-responders to any previous dietary / nutritional treatment * bmi \> 25 exclusion criteria: * subjects under the age of 18 and over 75 years. * subjects already undergoing bariatric surgical treatment * women who are pregnant or breastfeeding * hormonal therapies and / or chemotherapy in place * active mental or psychiatric illness * addiction to drugs of abuse or alcohol * other acute or chronic systemic disorders * severe hypertension (systolic blood pressure\> 200 mm hg and / or diastolic blood pressure\> 105 mm hg) * visual impairment (for completion of neuropsychological tests) * inability to complete home fmd
expanded access treatment protocol: remdesivir (rdv; gs-5734) for the treatment of sars-cov2 (cov) infection (covid-19)

Conditions: SARS-CoV2 Infection

Summary: the primary objective of this study is to provide expanded access of remdesivir (rdv) for the treatment of severe acute respiratory syndrome coronavirus (sars-cov2) infection.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under international conference on harmonization (ich) e6(r2) 4.8.15 emergency use provisions as deemed necessary by the investigator (participants ≥ 18 years of age), or willing and able to provide assent (participants ≥ 12 and \< 18 years of age, where locally and nationally approved) prior to performing study procedures. for participants ≥ 12 and \< 18 years of age, a parent or legal guardian willing and able to provide written informed consent prior to performing study procedures. * age ≥ 18 years or aged ≥ 12 and \< 18 years of age weighing ≥ 40 kg (where permitted according to local law and approved nationally and by the relevant institutional review board (irb) or independent ethics committee (iec)) * hospitalized with confirmed sars-cov2 by polymerase chain reaction (pcr) or known contact of confirmed case with syndrome consistent with coronavirus disease (covid-19) with pcr pending * oxygen saturation (spo2) ≤ 94% on room air or requiring supplemental oxygen at baseline * alanine aminotransferase (alt) \< 5 x upper limit of normal (uln) by local laboratory measure and/or alt \< 3 x uln and bilirubin \< 2 x uln * females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * lactating females must agree to discontinue nursing before the study drug is administered and while they are participating in the study exclusion criteria: * evidence of multiorgan failure including but not limited to coagulopathy (significant thrombocytopenia), hepatic failure (elevated bilirubin) or renal failure (low urine output or estimated glomerular filtration rate (egfr) \< 30 ml/min), or significant cardiomyopathy (low cardiac output) * use of more than 1 pressor for septic shock (note that use of 1 pressor at low/medium doses for inotropic support due to the use of sedation and paralytics while on the ventilator is allowed) * renal failure (egrf \< 30 ml/min using the cockcroft-gault formula for participants ≥ 18 years of age and schwartz formula for participants \< 18 years of age) or dialysis or continuous veno-venous hemofiltration) * eligible for enrollment in a randomized clinical trial studying remdesivir for treatment of sars-cov2 at the medical facility where the participant is admitted * known hypersensitivity to the study drug, the metabolites, or formulation excipient * requiring venous arterial (v-a) extracorporeal membrane oxygen (ecmo) (venous venous (v-v) ecmo is not an exclusion criteria)