Kornimate/medical-research-clean huggingface dataset:
specimen collection and transport workflow evaluations for clia-waived molecular testing

Conditions: Respiratory Tract Infections; Gastrointestinal Infection

Summary: the purpose of this study is two-fold. in the first phase, the goal is to characterize the stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; ns, nps, ts) and stool (raw stool and rectal swab) specimens collected using various standard, medically established procedures with and without transport media and tested at various time points and under different temperature conditions, and also to look at variation between repeat sampling events. the intention is for these data to support decisions made by biofire regarding the appropriate specimen type and handling guidelines for future tests. in the second phase of the study, collection and transport conditions identified in phase 1 will be used to collect specimens for pilot performance evaluations of a new molecular diagnostic test.

this evaluation will be initiated at several sites in the us. in the first phase of the study, multiple specimens will be collected from each subject and tested using various pre-analytical techniques. current biofire filmarray test panels will be used to assay each specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or other post-collection variables. in the second phase of the study only two specimens will be collected from each subject: one for testing with the new test (using handling procedures identified in phase 1) and another for testing with the reference method. up to 2,000 subjects will be enrolled across all sites in each phase (up to 4,000 subjects total). enrollment is expected to last approximately 18 months to cover both phases of the study. all specimens and subject data will be de-identified and coded. prior to study initiation, each participating site will have the necessary institutional review board (irb) reviews. specimens in both phases will be tested at the study site using various biofire test platforms and cartridges.

Eligibility criteria:
inclusion criteria: * subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue. or subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days * if age 18 or over, subject provides written informed consent * if under the age of 18, parental permission and assent (as appropriate) is obtained * subject is willing and able to provide at least two (up to three) specimens: any combination of ns, nps, or ts or rectal swab or stool exclusion criteria: * subject is unable to provide consent or parental permission and assent (as appropriate) cannot be obtained * subject is unable or unwilling to provide two specimens * subject's health care provider determines that specimen collection represents an unacceptable risk
pilot study on the acceptability of auricular vagus nerve neurostimulation in adolescents

Conditions: Psychiatric Disorder

Summary: non-suicidal self-injury (nssi) are acts defined by the dsm-5 (diagnostic and statistical manual of mental disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury. their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the covid-19 health crisis, with the prevalence of nssi rising to 40% in adolescents. access to psychiatrists is declining. drug solutions, meanwhile, lack scientific proof in this indication. the autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion. abnormally low levels of the latter hormone have been detected in persons with nssi disorder. transcutaneous neurostimulation of the atrial vagus nerve (tavns) has been studied for some ten years. the afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals. the hypothesis of this research is that stimulation of the vagus nerve by tavns would improve the functioning of the hypothalamic-pituitary axis in patients with nssi, and thus reduce the frequency of acting out. although tavns is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. the aim of this pilot study is to assess whether adolescents with nssi will adhere to tavns treatment.


Eligibility criteria:
inclusion criteria: * adolescents aged between 13 and 17 years old * patients with nssi disorder as defined by dsm-5 * patient affiliated to a social security scheme * patient who parents or guardians have signed a free and informed consent form * patient able to understand neurostimulation instructions exclusion criteria: * contraindication to tavns: * malformation, skin pathology of the external ear. (piercings in the area concerned must be removed during the neurostimulation session). * children with sleep apnea syndrome treated with niv (non-invasive ventilation) * presence of epileptic seizures * proven cardiac pathology on the advice of the attending cardiologist * history of venous or arterial thrombosis * adolescent with pacemaker or defibrillator * adolescent with an active implantable device * pregnancy (based on anamnestic criteria, checked by blood test if necessary) * patients with psychotic episodes, confusional states or severe neurodevelopmental disorders * patients with an allergic skin reaction to silicone (component of the ear electrode) * patients with a cochlear implant on the stimulation side * pregnant or breast-feeding women * minor under guardianship * minor under judicial measure or sanction

Keywords: non-suicidal self-injury transcutaneous auricular vagal nerve stimulation
fondaparinux in critically ill patients with renal failure

Conditions: Venous Thromboembolism

Summary: the primary objective of this study is to determine whether a dose-adjusted prophylaxis fondaparinux regimen of 2.5 milligrams (mg) subcutaneously administered every (q) 48 hours (hr) in patients with renal failure achieves peak and trough levels similar to patients with normal renal function, and protects patients from developing venous thromboembolism (vte). our hypothesis is that a dose-adjusted fondaparinux regimen, which extends the dosing interval from q24 to q48 hr, in patients with estimated creatinine clearance of \< 30 ml/min, will be safe and effective.

we will be studying fondaparinux 2.5 mg subcutaneously every 48 hr in three distinct patient groups: 1) acute kidney failure without hemodialysis, 2) acute kidney failure (aki) with intermittent hemodialysis (ihd) and 3) acute renal failure with continuous renal replacement therapy (crrt). all patients will be assessed for efficacy of the dose. efficacy will be assessed by following clinically for any evidence of vte, either deep venous thrombosis (dvt) or pulmonary embolism. in addition, lower extremity duplex studies will be performed at baseline and at the end of the study period to assess for dvt. secondary objectives will be safety and accumulation. safety will be determined by assessment of clinically significant bleeding, defined as a drop in hgb of \> 2 grams (gm) in 24 hr, or the need for red blood cell transfusion related to bleeding. accumulation may occur in renal failure and will be studied throughout the intensive care unit (icu) stay through reevaluation of levels over time.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old and ≤ 89 years old 2. body weight ≥ 50 kg or ≤ 150 kg 3. estimated creatinine clearance of \< 30 ml/min 4. predicted icu stay of more than 72 hours. exclusion criteria: 1. pregnant women 2. infective endocarditis 3. neuraxial anesthesia or spinal puncture 4. active bleeding 5. treatment with vitamin k antagonists or therapeutic doses of unfractionated heparin 6. signs of disseminated intravascular coagulation 7. severe liver failure (serum bilirubin \> 5 mg/dl) 8. surgery planned within 24 hours of icu admission 9. latex allergy

Keywords: fondaparinux renal failure critically ill
brief electronic intervention for heavy drinking and sex risk among msm seeking hiv testing

Conditions: HIV Infections; Alcohol Abuse

Summary: the overall objective of this research is to use both qualitative and quantitative data to inform the development of a technology-based intervention for heavy drinking and sexual risk behavior among men who have sex with men (msm) who are seeking free hiv testing. investigators will be conducting a randomized-controlled pilot test of the intervention among msm seeking hiv testing in community-based settings to explore its potential impact on alcohol and hiv-related behavioral outcomes. this research will ultimately produce a combined, theory-based, and technology- delivered intervention for heavy drinking and sex risk that is fully portable and has been preliminarily tested for efficacy in community settings where high-risk msm engage with prevention services.


Eligibility criteria:
inclusion criteria: 1. biologically male 2. aged 18 or older 3. fluent english speaker 4. unprotected anal sex with a casual male partner at least once in the past 3 months 5. heavy alcohol use during the past 2-weeks (\>14 drinks per week, or at least one occasion of 5+ drinks on a given occasion) 6. breath alcohol concentration (brac) of .000 at the time of enrollment 7. no history of complex alcohol withdrawal 8. hiv-negative exclusion criteria: 1. individuals who are hiv-positive 2. individuals who participated in other phases of the research 3. individuals who report being coerced to participate
an observational study of the real life management of the psoriasis patients treated with enbrel according to the new reimbursement criteria

Conditions: Plaque Psoriasis Patients

Summary: with the new reimbursement criteria, we want: to describe the average treatment duration of patients with enbrel expressed as a number of weeks/year. to describe the number of patients who receive continuous treatment to describe the number of patients who receive intermittent treatment to describe the number of weeks off treatment

100 patients will be followed for at least 1 year

Eligibility criteria:
inclusion criteria: * patient restarts or is starting treatment with enbrel for his/her psoriasis in alignment with reimbursement criteria * patients ≥18 year * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: n/a
effect of ramosetron on bowel motility after gynecological surgery

Conditions: Postoperative Nausea and Vomiting

Summary: ramosetron is effective in preventing postoperative nausea and vomiting. several studies reported that ramosetron is also effective treatment of irritable bowel syndrome. the investigators examine the effect of ramosetron on postoperative bowel motility.

ramosetron, a new potent and long-acting selective 5-ht3(5-hydroxytryptamine3) receptor anatagonist, is effective for preventing postoperative nausea and vomiting. also several studies reported that ramosetron is effective treatment of diarrhea-predominant irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone, there is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. in this study, the investigators examine the effect of ramosetron on postoperative bowel motility.

Eligibility criteria:
inclusion criteria: * 20-70 yrs of age * asa(american society of anesthesiologists) physical status class i or ii * scheduled for gynecological laparoscopic surgery exclusion criteria: * allergic to study drugs * antiemetics or steroids use within 24 hrs prior to surgery * dependence upon opioids * insulin dependent diabetes mellitus * cardiovascular or pulmonary disease * renal or hepatic insufficiency * bmi\>=35kg/m2 * history of motion sickness or ponv * cigarette smoker * conversion to open laparotomy from laparoscopic surgery * pregnants

Keywords: ponv digestive signs and symptoms vomiting antiemetics nausea ramosetron
factors affecting the time to start postoperative chemotherapy in colorectal cancer

Conditions: the Time to Start Postoperative Chemotherapy

Summary: colorectal cancers are common tumors and have undergone a great change in the last 20 years in terms of treatment principles. significantly improved results in local recurrence and overall survival have begun to be obtained with chemotherapy protocols given after surgery, which is the main element of the treatment system (1). it is known that postoperative chemotherapy protocols are commonly given within 6-8 weeks and this period is optimal. however, it was found that this period was prolonged in approximately 20% of these patients in the methanalysis performed (2). it has been shown that delay in applied chemotherapy causes a decrease in overall survival (3,4). the factors causing this delay have not been adequately examined in the literature. it is necessary to investigate these factors that affect the overall survival outcomes, which are the main pillars of treatment principles, and to regulate the factors that have the opportunity to improve. in this study, our aim is to investigate the perioperative (preop-perop-postop) factors affecting the duration of postoperative chemotherapy initiation in patients with colorectal cancer treated in our hospital.


Eligibility criteria:
inclusion criteria: patients who underwent colorectal resection exclusion criteria: patients with missing data

Keywords: laparoscopy overall survival local recurrence tumor chemotherapy colorectal cancer
anger and cardiovascular risk in urban youth

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Obesity

Summary: to examine anger and cardiovascular disease risk in urban youth. the project studied patterns of hemodynamic responses to social and nonsocial stressors, ambulatory blood pressure (bp), fasting insulin, fasting glucose, lipid profiles, and central obesity in adolescents from a wide range of socioeconomic status (ses) backgrounds.

background: urban adolescents at high risk for cardiovascular disease (cvd) exhibit a pattern of hemodynamic responses that: (a) is evoked by social encounters that arouse anger, defensiveness, and distrust; (b) appears related to increased insulin resistance; (c) is more pronounced in males and african americans; and (d) may constitute a pathway via which chronic exposure to stressful social environments increases cvd risk. design narrative: there were four studies. study 1 in the first two years measured hemodynamics in 200 subjects to test the hypothesis that hostile distrust was associated with increased total peripheral resistance (tpr) response to social challenge, and that adolescents exhibiting this response pattern had elevated levels of ambulatory bp, fasting insulin, glucose, blood lipids, and central obesity. study 2 followed 200 subjects for four years to determine if defensive hostility and distrust were related to tracking at higher levels of bp (measured every 6 months), and insulin/ glucose/ cholesterol (measured once per year). study 3 in years 3 and 4 evaluated the influence of race on the cross-situational consistency of hostile distrust/bp by measuring the latter responses in 200 adolescents during structured encounters with a friend of the same race and sex, an unfamiliar same-race peer, and an unfamiliar other-race peer (black or white). study 4 evaluated video and audiotape recordings from studies 1 and 3 to test the hypothesis that distrustful individuals expressed more hostile affect in encounters with others, elicited more negative treatment, were perceived as hostile regardless of observer race or gender, and thus experienced chronic, health-damaging interpersonal stress. study 4 data were used to examine the possibility that hostile distrust is related to exposure to crime, poverty, and racial discrimination. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
changes of optical quality during the peak of the covid-19 pandemic

Conditions: Corneal Wavefront Aberration; SARS-CoV-2

Summary: to explore whether cornea structure, and optical quality are affected by the covid-19 infection.

participants with healthy corneas admitted to tianjin eye hospital from november 25 to january 20, 2022 were followed up . at the end of the follow-up, the investigators recorded in detail whether the patients had undergone real-time reverse transcriptase polymerase chain reaction (covid-19 rt-pcr tests) testing, testing time and results. the presence of pcr-positive during follow-up is considered to be covid-19 infection; pcr-negative and no symptoms of infection during the follow-up period are considered not infected; participants with symptoms but no pcr test were excluded from the study.participants were divided into three groups according to the rt-pcr results and the presence or absence of symptoms of infection during follow-up. pentacam (pentacam hr, oculus, wetzlar, germany) was performed during follow-up and the results were recorded,and the data was statistically managed and compared.

Eligibility criteria:
included criteria 1. best corrected visual acuity (bcva) ≥ 20/20; 2. no other eye diseases except myopia and astigmatism; 3. the cornea was transparent, and there was no cloud or pannus; 4. no clinical manifestation of eye disease or systemic disease; exclusion criteria: 1. corneal disease; 2. ocular trauma; 3. pregnant and lactating women;

Keywords: optical quality
regulatory t-cells in psoriasis patients as targets for therapy

Conditions: Psoriasis

Summary: the aim of this study is to understand which therapies will suppress effector cells and promote regulatory t cells and to test whether patients with a better response to therapy and longer psoriasis-free periods develop a higher numerical ratio of regulatory to effectors t-cells and/or regulatory cells more able to suppress the effectors.

this is an observational study for the effect of different treatment options of psorisis on regulatory t-cells. patients in whom a decision to treat with one of the following therapies (dovobet, neotigason, narrow-band uvb and anti tnf alpha therapy) and agreed to take part in the study will be selected. allocation of different treatments to patients is not part of the study. we will enroll 40 patients with moderate to severe psoriasis in the age range from 18 to 70. patients must be treatment-free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. females of child bearing potential must be on reliable contraception. children below 18 years, patients above 70 years, pregnant and lactating patients and immunosuppressed patients are excluded from this study. blood and tissue samples will be taken before and after treatment. we will also invite 10 patients who are receiving ellipse excisions of naevi, and who known not to have psoriasis, to provide control samples of distal skin beyond the margins required to demonstrate complete removal and control donation of blood.

Eligibility criteria:
inclusion criteria: * • male and female patients in the age range from 18 to 70 who are diagnosed with moderate to severe psoriasis. * patients must be treatment free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. * women of child bearing potential must be on reliable contraception. * patients in whom a decision to treat with one of the following therapies has already been made based on normal clinical care: * dovobet * neotigason * narrow-band uvb * etanercept * adalimumab * infliximab * 10 normal controls exclusion criteria: * • children below 18 years and patients over 70 years. * pregnant and lactating patients. * patients who are known to have immunosuppressive disease (e.g. hiv) or on any immunosuppressive therapy.

Keywords: regulatory t-cells, psoriasis, il-10.
a study to evaluate fmri of active dbs stimulation in epilepsy

Conditions: Refractory Epilepsy

Summary: the purpose of this study is to use functional imaging to study the mechanisms of the anterior nucleus of the thalamus (ant) deep brain stimulation (dbs).

researchers are testing how changing the settings on deep brain stimulation device (dbs) can help reduce the number and severity of seizures. functional imaging will be used to study the mechanisms of ant dbs to optimize the device settings to improve the degree of seizure reduction.

Eligibility criteria:
inclusion criteria: - patients who have previously undergone anterior thalamic nucleus deep brain stimulation (dbs) for refractory epilepsy. exclusion criteria: - contraindication to mri; prior brain resective surgery or large area of brain tissue loss (e.g., large area infarction).

Keywords: deep brain stimulation
tlk286 (telcyta) in combination with cisplatin for locally advanced or metastatic non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this trial is to study the efficacy and safety of the combination of tlk286 with cisplatin as first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * histologically confirmed non-small cell lung cancer * stage iv or iiib * measurable disease by recist * ecog performance status of 0-1 * adequate liver and renal function * adequate bone marrow reserve exclusion criteria: * history of bone marrow transplantation or stem cell support * pregnant or lactating women