Kornimate/medical-research-clean huggingface dataset:
rapid diagnostics for traumatic brain injury (tbi)

Conditions: Traumatic Brain Injury

Summary: novel biomarkers of traumatic brain injury (tbi) have been discovered in laboratory animal models. the objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a tbi.

staff of the neurosurgical ward is asked to report to the study coordinator all patients who are hospitalized due to a suspected brain injury. after an informed consent is received, the patient has been enrolled in the study and sample collection can be started. plasma samples are taken by the tykslab personnel, and the other samples by the nurses in the neurosurgical ward. the sampling will be organized so that all the samples from a patient are preferably collected at one event. samples will stored in the tykslab at the temperature of -70 °c. collection of a sufficient number of samples (patients) will take a few months, and subsequent analysis by the sponsor a few months. all the activities will be done during the years 2016 to 2017. when the samples of 24 subjects have been collected, they will be transferred to the sponsor who will ship them further to the sub-contractors. the results received from the research laboratories will be evaluated by the scientist team at medicortex finland oy. the results will be published in a scientific journal, when considered to be of high enough quality and impact.

Eligibility criteria:
inclusion criteria: * patient is hospitalized because of a head trauma and suspected tbi. * age 18 or above. the subject (including the control subjects) must be an independent adult who is not under guardianship. * the patient, or the next of kin in the case of an incompetent person, has signed the informed consent. this concerns the control subjects, too. * the samples can be collected during regular office hours. * the patient needs lumbar puncture for treatment reasons. this is not a limiting criterion however. if it is difficult to find an adequate number of patients for lumbar puncture, csf samples of some patients can be omitted after the study coordinator's consideration. exclusion criteria: * the subject has been found positive for hiv or hepatitis-b in the involved laboratory studies. * the subject has a chronic mental disorder which is mentioned on the sickness insurance card.
phase iii hallmark quad: asv+dcv+peg+rib (nulls/partials)

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to assess efficacy, as determined by the proportion of subjects with sustained virologic response at post-treatment week 12 (svr12), defined as hepatitis c virus (hcv) ribonucleic acid (rna) \< limit of quantitation (loq) at post-treatment week 12.

* asv = asunaprevir (bms-650032) * dcv = daclatasvir (bms-790052) * peg = peg-interferon alfa-2a (pegifn) * rib = ribavirin (rbv)

Eligibility criteria:
inclusion criteria: * males and females, ≥ 18 years of age * hcv genotype 1 or 4 who previously failed treatment with peginterferon alfa-2a or peginterferon alfa-2b and ribavirin (p/r), classified as previous null and partial responders based on previous therapy * hcv rna ≥ 10,000 iu/ml * seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag) * subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population) exclusion criteria: * prior treatment of hcv with hcv direct acting antiviral (daa) * evidence of a medical condition contributing to chronic liver disease other than hcv * evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * diagnosed or suspected hepatocellular carcinoma or other malignancies * uncontrolled diabetes or hypertension * total bilirubin ≥ 34 μmol/l (or ≥ 2 mg/dl) unless subject has a documented history of gilbert's disease * alanine aminotransferase (alt) ≥ 5x upper limit of normal (uln) * albumin \< 3.5 g/dl (35 g/l) * alpha fetoprotein (afp) \> 100 ng/ml (\>82.6 iu/ml) or ≥ 50 and ≤ 100 ng/ml requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (hcc) are excluded * absolute neutrophil count (anc) \< 1.5 x 1000,000,000 cells/l (\< 1.2 x 1000,000,000 cells/l for black/african-americans) * platelets \< 90 x 1000,000,000 cells/l * hemoglobin \< 12 g/dl for females or \< 13 g/dl for males * any criteria that would exclude the subject from receiving p/r
phamacokinetics and safety profiles of da-1229_01 2.5/500mg in healthy subjects at fasting state

Conditions: Healthy

Summary: this phase i clinical study is to evaluate the safety/tolerability and pharmacokinetics of da-1229_01(2.5/500 mg) at fasting state.


Eligibility criteria:
inclusion criteria: * healthy volunteers * bmi between 18 and 30 kg/m2 * body weight : male≥50kg, female≥45kg exclusion criteria: * allergy or drug hypersensitivity * clinically significant medical history
acute exposure of simulated hypoxia on ecg and non-invasive blood pressure

Conditions: Pulmonary Hypertension

Summary: randomized crossover trial in patients with pulmonary hypertension (pah, cteph) to assess the acute response to simulated altitude (fio2: 15.1% = equivalent to 2500m above sea level) on ecg repolarizations and non-invasive blood pressure measurements by finapres® nova technology.

low altitude baseline measurements will be performed in zurich (469m asl) including echocardiography, right heart catheterization, six minute walking test (6mwt), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. randomly assigned to the order of testing, the participants will e tested under simulated altitude (fio2: 15.1% with the "amc altitrainer") and shamed altitude with the same device. during the exposure to simulated altitude (fio2: 15.1%) and shamed altitude of 1 hour each, the participants' ecg and non-invasively assessed blood pressure by finapres at rest and under exercise will be collected.

Eligibility criteria:
inclusion criteria: * informed consent * ph diagnosed according to internation guidelines: mean pulmonary artery pressure (mpap) ≥ 25 mmhg along with a pulmonary artery wedge pressure (pawp) ≤15 mmhg during right heart catheterization at the time of initial diagnosis * ph class 1 (pah) or 4 (cteph) * stable condition, on the same medication for \> 4 weeks * patient live permanently at an altitude \< 1000m asl. exclusion criteria: * resting partial o2 pressure (pao2) ≤7.3 kilopascal (kpa) corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * severe daytime hypercapnia (pco2 \> 6.5 kpa) * susceptibility to high altitude related diseases (ams, high altitude pulmonary edema (hape), etc.) based on previous experienced discomfort at altitudes. * exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * residence \> 1000m above sea level * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability * women who are pregnant or breast feeding

Keywords: simulated altitude exercise electrocardiography non- invasive blood pressure
low dose aspirin inhibition of cox-2 derived pge2 in male smokers

Conditions: Tobacco Use Disorder; Smoking

Summary: regular aspirin use has been associated with a reduction in the development of a number of different malignancies including lung cancer. the mechanism of aspirin's cancer prevention is not known. this study will evaluate whether once daily aspirin use can reduce the production of a protein named prostaglandin e2 (pge-2), which is known to promote cancer. specifically, this study will evaluate if aspirin can inhibit the production of pge-2 by blocking an enzyme named cycloxygenase-2 (cox-2). to accomplish these goals, participants will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various days of this 16-day study. urine be collected to evaluate for pge-2 production at 4 timepoints in this 16-day study.


Eligibility criteria:
inclusion criteria: * male gender * age ≥35 * current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py) * former smoker, quit no more than 15 years ago with a history of at least 25 py * ability to comply with the design of the study * capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner * baseline urine pge-m \> 13 ng/mg creatinine * serum thromboxane \> 150 μg/l exclusion criteria: * history of aspirin use 1-14 days prior to screening * nsaid (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening * inhaled glucocorticoid use 1-7 days prior to screening * systemic glucocorticoid use 1-14 days prior to screening * history of peptic ulcer disease * current or recent clinically significant bleeding * allergy, intolerance or contraindication to aspirin or nsaid use * thrombocytopenia (platelet count \< 100,000) in 30 days prior to screening visit * severe hepatic insufficiency * gfr \< 30 ml/min/1.73 m2 in 30 days prior to screening visit * history of aspirin or celecoxib allergy * elevated inr (\>1.5) in 30 days prior to screening visit * current diagnosis of malignancy or history of non-skin malignancy in last 5 years * current use of systemic anticoagulants (e.g., warfarin (coumadin), enoxaparin (lovenox), fondaparinux (arixtra), dabigatran (pradaxa)) * diagnosis of copd * intake of \> 250 mg of fish oil supplementation daily
a placebo-controlled, double-blind comparative study of e2080 in lennox-gastaut syndrome patients (study e2080-j081-304)

Conditions: Lennox-Gastaut Syndrome

Summary: to confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with lennox-gastaut syndrome.


Eligibility criteria:
inclusion criteria 1. participants who are diagnosed as lennox-gastaut syndrome with tonic/atonic seizures and atypical absence seizures (a history of atypical absence seizures will also be incorporated). 2. participants who had a slow spike-and-wave pattern in an electroencephalogram within 6 months prior to the enrollment for the observation period. 3. participants who had at least a total of 90 seizures in the 28 days prior to the enrollment for the observation period. 4. participants who have been on 1 - 3 anti-epileptic drugs from 28 days prior to the enrollment for the observation period and have not changed the type of the anti-epileptic drugs. 5. participants who have not changed the type nor the dose or administration of the anti-epileptic drugs they are taking in the observation period. exclusion criteria; 1. participants who had a history of generalized tonic-clonic status epilepticus within baseline. 2. participants who received drug therapy at least 4 times to be rescued from status epilepticus within baseline. 3. participants who had a history of hypoxia which needed emergency resuscitation within 12 months prior to the treatment period. 4. participants who were on a ketogenic diet or have received adrenocorticotropic hormone (acth) therapy or vitamin b6 therapy within 6 months prior to the treatment period. 5. participants who had a history of suicide attempt within the 1 year prior to the treatment period. 6. participants who had a history of or has an allergy to triazole compound. 7. participants who have clinically significant electrocardiogram abnormalities at baseline. 8. participants who are pregnant, who may be pregnant, who are lactating or who wish to be pregnant.

Keywords: epilepsy seizures
tracking atopic dermatitis infants and their microbiome (tram)

Conditions: Atopic Dermatitis; Pediatric ALL

Summary: tracking atopic dermatitis infants and their microbiome: a study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on onebiome real-world evidence research platform.

parents of healthy infants as well as parents of infants with early onset eczema: * user experience of reading and understanding the microbiome and eating pattern analysis reports * user experience of using and understanding the microbiome and nutrition platforms that allow parents to monitor microbiome and eating patterns of their child overtime

Eligibility criteria:
inclusion criteria: 1. infants diagnosed with early onset eczema (\<12 months of age) and healthy infants (\<6 months of age, before weaning). 2. parents of children should have access to the internet and a smartphone or tablet to access the onebiome mobile friendly website. 3. parents of children should be able to comprehend the content in the onebiome mobile friendly website and complete the questionnaires in english. 4. parents of children should stay in singapore and remain contactable. exclusion criteria: 1. children born prematurely. 2. children with a chronic illness. 3. children with congenital malformations, surgeries in the neonatal period or genetic syndromes. 4. incapability of the parents of children to access onebiome mobile friendly website and complete the questionnaires in english. 5. any other family member is enrolled in the study. 6. incapability of the parents of children to comply with study protocol or investigator's uncertainty about the willingness or ability of the parents of children to comply with the protocol requirements.

Keywords: microbiome atopic dermatitis pediatric
a study to evaluate the safety and efficacy of long-term treatment with tez/iva in cf participants with an f508del cftr mutation

Conditions: Cystic Fibrosis

Summary: this study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (tez/iva) in participants with cystic fibrosis (cf) aged 6 years and older, homozygous or heterozygous for the f508del mutation.


Eligibility criteria:
inclusion criteria: * completed the week 24 visit in study 113 part b or the week 8 visit in study 115 * eligible cftr mutation exclusion criteria: * pregnant and nursing females * history of poor compliance with study drug and/or procedures in a previous study as deemed by the investigator * ongoing participation in another study with investigational drug other protocol defined inclusion/exclusion criteria may apply.
vr-pat during home burn dressings - multisite

Conditions: Burns; Acute Pain; Procedural Pain; Injuries; Pediatric ALL

Summary: this study will evaluate the effectiveness of smartphone virtual reality pain alleviation therapy (vr-pat) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the vr-pat.

in this two-group randomized clinical trial, participants will be randomly assigned to either the vr-pat intervention group or control group (standard distraction techniques available in the home). participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. participants and caregivers in the intervention group will answer additional questions about their experience using the vr-pat, ease of use, and helpfulness. surveys will be repeated with each dressing changes for one week.

Eligibility criteria:
inclusion criteria: * being treated for acute burn injury * age 6-17 years, inclusive * receiving their first outpatient clinic dressing change or being discharged from the ed or inpatient burn unit * have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ed or inpatient) * patient and family caregivers can communicate (read and write) using english or spanish * reported at least moderate or worse nrs pain score of ≥3 (nrs 0-10 with 10 being worst pain) from the most recent dressing change. exclusion criteria: * any wounds that may interfere with study procedures * vision, hearing, or cognitive/motor impairments preventing valid administration of study measures * history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras * minors in foster care, prisoners, or currently pregnant * suspected child abuse * families who do not have access to a vr compatible smartphone.

Keywords: virtual reality vr burns pain
influenza vaccine to prevent adverse vascular events (rct-ivve)

Conditions: Heart Failure; Influenza

Summary: a multi-centre, randomized, placebo controlled, trial. participants at high-risk for vascular events from the network of inter- chf will be randomized to inactivated influenza vaccine or placebo and followed prospectively over three influenza seasons. 5,000 participants will be enrolled prior to influenza season, randomized to either influenza vaccine or saline placebo, either of which they will receive annually for three years and then followed over each of the influenza seasons.

cardiovascular disease is a major cause of morbidity and mortality. there is recent evidence that infection due to influenza may precipitate vascular events such as myocardial infarctions and strokes. there is some evidence that influenza vaccination may prevent such events but the data are inconclusive. the investigators propose a randomized controlled trial to assess whether influenza vaccination will prevent vascular illness. adults with clinical heart failure will be randomized to inactivated influenza vaccine or saline placebo each year for three consecutive years. they will be followed over six months for a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. rigorous demonstration of influenza vaccine leading to a reduction in major adverse vascular events in patients with heart failure would lead to a major change in how these patients are managed. given the large burden of disease both in canada and globally, the possibility to reduce cardiovascular and stroke related death is a compelling reason to conduct this trial.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and nyha (new york heart association) functional class ii, iii and iv exclusion criteria: * anaphylactic reaction to a previous dose of tiv(trivalent influenza vaccine) * known ige( immunoglobulin e)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock * guillain-barré syndrome within eight weeks of a previous influenza vaccine * anaphylactic reaction to neomycin * patients who have had influenza vaccine in two of the three previous years

Keywords: influenza vaccine heart failure vascular
collecting recorded videos of colonoscopy

Conditions: Colon Polyp

Summary: the study shall mainly help to better evaluate the performance the apds device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon polyps.

primary objectives • to evaluate, in objective way, the usability of the future alpha version of the apds device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of colonoscopy screening tests of the general population. secondary objectives • when the apds would be ready for field installation (beta version), to install it in the gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the apds performance.

Eligibility criteria:
inclusion criteria: subjects must meet all the - criteria related to regular colonoscopy according to the standard of care at the gastroenterology department of the selected center, _in addition the following - criteria have to be met to be eligible for the study: 1. able to read, understand and provide written informed consent; 2. females or males - older than 18 years old exclusion criteria: any of the following colonoscopy related exclusion criteria will exclude the subject from the study: * bleeding disorder or unacceptable risk of bleeding * terminal illness or life threatening malignancy
efficacy trial comparing zd6474 with erlotinib in nsclc after failure of at least one prior chemotherapy

Conditions: Non Small Cell Lung Cancer

Summary: to determine if zd6474 a new investigational drug, is effective in treating non small lung cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, erlotinib


Eligibility criteria:
inclusion criteria: * confirmed locally advanced or metastatic nsclc * failure of at least one but not more than two prior chemotherapy regimens exclusion criteria: * prior treatment with erlotinib (tarceva), gefitinib (iressa), sunitinib (sutent), sorafenib (nexavar) * chemotherapy or other type of anti cancer therapy within 4 weeks of study start

Keywords: non small cell lung cancer nsclc
explore the efficiency of fiberscope-guided nasogastric tube insertion

Conditions: Nasogastric Tube Esophagitis

Summary: for head and neck cancer and uncooperative patients, blind nasogastric tube (ngt) insertion may sometimes be very difficult because of the anatomical obstructions in the pharynx and uncoordinated swallowing motion. to solve the problem, flexible endoscope has been used widely to assist the ngt insertion via direct visual assistance, working channels/guide wires, or suture fixation. unfortunately, these tools are not easily assessed in the outpatient department. here, we try to use a simpler method for the flexible endoscope to guide the ngt insertion.

ngt and fiberscope was combined to facilitate ng tube insertion

Eligibility criteria:
inclusion criteria: dysphagia patients who need nasogastric tube feeding exclusion criteria: patients who ever had human immunodeficiency virus infection and were not suitable for fiberscope exam without protection sheath

Keywords: cancer patients, nutritional status
collaborative care intervention for chronic kidney disease

Conditions: Kidney Transplant; Depression; Pain

Summary: the aims of the present study will be to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

symptom management is critical to maintain quality of life in those with life limiting conditions. stepped collaborative care interventions have been widely employed in the primary care setting for the treatment of depression and more recently have been utilized to treat other symptoms (e.g., pain) in a variety of settings. a recent meta-analyses concluded that collaborative care interventions were superior to usual care and are more cost-effective than face to face and pharmacological treatment for depression. collaborative care interventions have begun to be extended to other settings but have not been tested in patients who are being treated with dialysis. the aims of the present study were to pilot test the efficacy of a collaborative care intervention in patients awaiting kidney transplant to reduce symptoms of depression, pain, fatigue and improve quality of life.

Eligibility criteria:
inclusion criteria: age 18 or older currently receiving dialysis at upmc dialysis facility for chronic kidney disease fluent in english exclusion criteria: under the age of 18 years or over 90 years not fluent in english

Keywords: collaborative care intervention kidney transplant