Kornimate/medical-research-clean huggingface dataset:
zalutumumab in non-curable patients with scchn

Conditions: Head and Neck Cancer; Squamous Cell Cancer

Summary: treatment, in combination with bsc, open-label, single arm, efficacy study.


Eligibility criteria:
inclusion criteria: 1. males and females age ≥ 18 years 2. confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy 3. failure to at least one course of standard platinum-based chemotherapy exclusion criteria: 1. three or more prior chemotherapy regimens 2. prior treatment with egfr antibodies and/or egfr small molecule inhibitors 3. past or current malignancy other than scchn, except for certain other cancer diseases
naproxen sodium/acetaminophen proof of concept dosing study

Conditions: Pain

Summary: study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and placebo in a postoperative dental pain.

this is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars.

Eligibility criteria:
inclusion criteria: 1. males of females 17-50 years old 2. weigh 100 pounds or greater and have a body mass index (bmi) of 18.5 to 35 (inclusive) at screening 3. surgical removal of up to four third molars, of which, two must be mandibular impactions 4. meets requirements for post -surgical pain level 5. females of childbearing potential and males agree to contraceptive requirements of study 6. have a negative urine drug screen at screening, and on day of surgical procedure exclusion criteria: 1. pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant 2. have known allergy or hypersensitivity to naproxen or other nsaids, including aspirin, or to acetaminophen, tramadol, hydrocodone or other opioids 3. not able to swallow large tablets or capsules 4. history of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study 5. use analgesics 5 or more times per week 6. history of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years 7. use of immunosuppressive drugs within 2 weeks of screening 8. history of peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding

Keywords: analgesics dental pain naproxen acetaminophen pain
rebound exercise in neurological disorders

Conditions: Neurological Diseases or Conditions

Summary: this study will be a pretest-posttest interventional trial investigating the use of rebound exercise in community-dwelling individuals with neurological disorders.

neurological disorders are linked to various problems, including but not limited to movement impairments, balance, fear of falls, reduced exercise tolerance, loss of muscle strength, reduced functional independence, sedentary behaviour and reduced quality of life. these impairments can lead to physical deconditioning, functional dependency and extreme disability if left unmanaged, creating the need for prompt treatment. rebound exercise is an effective and safe form of aerobic exercise that has been successfully used in some populations. it can be included in rehabilitating people with neurological disorders for its beneficial effects on humans and minimal stress on the heart and joints. its fun-giving experience makes it easier to engage regularly compared to traditional exercise tools that may feel like a task. it is also more affordable and less time-consuming than other standard modalities. the few available studies on rebound exercise in neurological disorders were mostly in inpatients, and evidence is scarce on the use of rebound exercise in community-dwelling individuals with neurological disorders. it is thus necessary to investigate its use in the community context as well as the minimal effective dosage of the intervention. this study will investigate the frequency of rebound exercise necessary to effect changes in physiological and functional outcomes such as heart rate, blood pressure, physical activity level, walking speed, risk of falls, cognitive function and quality of life. the enrolled participants will undergo 12 weeks of rebound exercise training once or twice weekly, depending on their frequency choice. ethical approval has been sought and obtained from the research ethics committee of buckinghamshire new university. eligible volunteer participants will be asked to sign the informed consent after the study has been explained to them. they will be assured of data confidentiality by anonymising their information and will also be informed of their right to withdraw at any point.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of a neurological disorder of upper motor neurone origin such as stroke, multiple sclerosis, parkinson's disease, traumatic brain injury etc * must score 3 or less on the modified rankin scale for disability status * must be able to walk with or without walking aids for at least 2 minutes * have a body weight of \<120 kg * must be able to understand therapy instructions. exclusion criteria: * pregnancy * other significant comorbidities * cardiovascular or respiratory system disorders * musculoskeletal disorders * visual or auditory sensory disorders. * cancer * genu recurvatum

Keywords: neurological disorders rebound mini-trampoline exercise /therapy walking speed fall risk quality of life
poor theoretical knowledge and self-assessed ability of cardiopulmonary resuscitation among in-hospital healthcare professionals: a cross sectional study with questionnaires.

Conditions: In-hospital Cardiac Arrest

Summary: theoretical knowledge of cardiopulmonary resuscitation (cpr) is the foundation of being able to perform cpr in a cardiac arrest situation. the knowledge and skills received in training is easily lost and after one year the level is equal to pretraining. international studies regarding knowledge of cpr among healthcare professionals, mostly nurses, show poor results. the knowledge of cpr among swedish healthcare professionals is poorly studied. the aim of this study was to describe the theoretical knowledge of cpr and self-assessed abilities of performing cpr among healthcare professionals working in four hospitals in sweden.

a questionnaire will be handed out containing a knowledge test of nine questions at a basic level. the questionnaire also contains likert-scales that measures four self-assessed cpr abilities of the respondents (the ability to take leadership, give compressions, to ventilate and to defibrillate).

Eligibility criteria:
inclusion criteria: * healtchare professionals of all professions * working in-hospital with patient contact * present at the time of the survey exclusion criteria: * not working with patients * abscent at the time of the survey

Keywords: cardiopulmonary resuscitation knowledge in-hospital cardiac arrest skills
anxiety, depression, and quality of life in patients with fibromyalgia during the coronavirus disease 2019 pandemic

Conditions: Fibromyalgia; Coronavirus Disease 2019 Pandemic

Summary: fibromyalgia patients and controls living in the same household will be evaluated for levels of resilience, covid-19 related anxiety, coronavirus disease 2019 related obsession, quality of life and pain and comparisons and correlation analyses will be carried out.

fibromyalgia is a generalized pain condition that is accompanied by sleep disturbances, anxiety, depression and somatic symptoms. during coronavirus disease 2019 pandemic, fibromyalgia patients as well as the general population have increased anxiety levels. this study was planned to evaluate fibromyalgia patients' levels of coronavirus disease 2019 related resilience, anxiety, obsession levels about coronavirus disease 2019, quality of life and pain levels and compare them with healthy controls living in the same household.

Eligibility criteria:
inclusion criteria: * having a diagnosis of fibromyalgia according to the american college of rheumatology 2016 classification criteria * older than 18 years of age exclusion criteria: * illiteracy * a history of coronavirus disease 2019 infection in the last month * change in medication to treat fibromyalgia in the last 3 months * living alone (lack of a control subject) * severe neurological or psychiatric disorder that might hinder subjects' ability to answer the study questions

Keywords: fibromyalgia coronavirus disease 2019 pain anxiety quality of life
the effect evaluation of continuous nursing intervention in patients with type 2 diabetic retinopathy

Conditions: Type 2 Diabetic Retinopathy

Summary: objective: to evaluate the application effect of continuous nursing intervention in type 2 diabetic retinopathy (dr), and to explore its clinical application value. methods：patients with type 2 dr admitted to our hospital from june 2019 to june 2022 were selected as the research objects and divided into intervention group and control group by random number table method. the control group received routine nursing intervention, and the intervention group received continuous nursing intervention on the basis of the control group. the related effect evaluation indexes such as fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin and visual acuity were collected and compared between the two groups at discharge, 1 year and 2 years after discharge. the readmission rate of the two groups was counted to evaluate the effect of continuous nursing intervention.


Eligibility criteria:
inclusion criteria: * (1) dr diagnosis and classification criteria in line with the latest version of the 2017 clinical guidelines for diabetic retinopathy developed by the american eye association \[9\]; * (2) type 2 diabetes course of more than 5 years, with varying degrees of retinopathy; * (3) monocular disease, no blindness; * (4) education level above primary school; - (5) patients informed consent for this study and signed a consent form. exclusion criteria: * (1) with severe cerebral hemorrhage or cerebral infarction, severe nephrotic syndrome, senile dementia, cardiovascular and cerebrovascular diseases; * (2) patients with macular edema, severe corneal (and) or lens opacity affect the observation of the fundus, angle-closure glaucoma can not mydriasis, other fundus diseases, and nursing interventions for other chronic diseases. this study was approved by the ethics committee of our hospital.
escalating ketamine doses and pre-emption

Conditions: Postoperative Pain Management

Summary: ketamine affects postoperative pain when administered intravenously immediately before, during or at the end of surgical procedures. we assessed the effects of multiple and escalating doses of ketamine administered many hours before surgery on postoperative pain and analgesia consumption.


Eligibility criteria:
inclusion criteria: consecutive patients, who were scheduled to undergo general or orthopedic oncologic surgery under general anesthesia exclusion criteria: 1. allergy to opioids, ketamine or non-steroidal anti-inflammatory drugs (nsaids) 2. history of lasting chronic pain or psychiatric disorders or had used opioids or psychotropic drugs of any sort during the past two weeks 3. soldiers and pregnant women

Keywords: preemption, ketamine, escalating, dose, pain, analgesia
ed decision making among hypotensive patients

Conditions: Hypotension

Summary: the goal of this study is to assess decision making skills of emergency physicians when dealing with hypotensive patients. the hypothesis is that decisions made based on physical exam and vital signs regarding fluid resuscitation by emergency physicians are not statistically equivalent to those that would be made based on the use of a non-invasive cvp measurement

if physicians can make appropriate decisions about the need for fluid resuscitation without cvp measurement, then this skill is worth being passed to physicians in training. previously it was not possible gather enough information about the response of patients' because of the risk of using indwelling cvp sensors. but now because there is a low risk tool (venus 1000 system), this study is now practical and safe.

Eligibility criteria:
inclusion criteria: * all patients \>=18 years of age who enter the emergency department at hahnemann hospital with systolic blood pressure \< 100 mm hg exclusion criteria: * those patients who are suffering from traumatic injury requiring level i or level ii trauma evaluations. example conditions include penetrating injuries to head, torso and proximal extremities. * additional exclusion criteria include the presence of an internal jugular or a subclavian central venous line or both external jugular veins being cannulated (attempted or successful) with peripheral ivs. * pregnant females will be excluded. * subjects under the age of 18 years will be excluded

Keywords: systolic blood pressure < 100 mm hg
rifaximin to prevent recurrent hcv-related fibrosis after liver transplant

Conditions: Hepatitis C

Summary: the purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent hepatitis c virus (hcv) by lowering serum lipopolysaccharide (lps), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver. approximately 60 subjects will participate in this study. subjects will be part of the study for approximately 1 year post transplant.

hepatitis c virus (hcv) is the most common chronic liver infection and remains the leading indication for liver transplantation (lt). although lt is a cure for cirrhosis of the liver, it does not always cure hcv infection or reinfection of post-transplanted liver. post-lt recurrent hcv can lead to accelerated liver fibrosis. chronic exposure to lipopolysaccharide (lps) from gut-derived bacteria has shown to be at elevated levels in patients with cirrhosis due to hcv compared to normal controls. therefore, the investigators hypothesize that lps contributes to cause of liver fibrosis, specifically in patients with post-lt recurrent hcv, and this effect maybe modified with the poorly absorbed antibiotic, rifaximin, which alter the gut flora of the patients.

Eligibility criteria:
inclusion criteria: * subject must provide written informed consent before any study assessment is performed * age ≥ 18 years * willing and able to sign informed consent * chronic hcv infection with viremia * listed for liver transplantation * demonstrate ability to take oral medications prior to randomization (post lt) exclusion criteria: * age \< 18 years old * unwilling/able to sign informed consent * cleared hcv infection (and therefore not at risk for recurrent hcv) * human immunodeficiency virus (hiv) co-infection * hepatitis b (hbv) co-infection * participation in another interventional clinical trial * females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study * subjects with history of hypersensitivity to rifaximin, rifampin, rifamycin antimicrobial agents, or any of the components of rifaximin * subjects with history of tuberculosis infection or has received treatment for tuberculosis infection. if subject has previous positive test for tuberculosis antigen then they must have current negative chest x-ray to be eligible * subject has diarrhea and positive clostridium difficile (c. difficile) toxin via stool examination during screening period. note: stool examination for c. difficile toxin will be performed on subjects who have diarrhea during the screening period. results of stool tests should be confirmed as negative prior to randomization

Keywords: liver transplant recipient recurrent fibrosis
safety, efficacy, pharmacokinetics, pharmacodynamics of acz885 in patients with nalp3 mutations and clinical symptoms

Conditions: NALP3 Mutation

Summary: this study will investigate the clinical efficacy, safety, pharmacokinetics (pk) and pharmacodynamics (pd) of acz885, administered intravenously and subcutaneously to patients with nalp3 mutations whose clinical symptoms are either untreated or insufficiently treated and require medical intervention.


Eligibility criteria:
inclusion criteria: * patients aged 4 to 75 years (inclusive) * body weight ≥ 12 kg and \< 100 kg. * females of child-bearing potential must have a negative pregnancy test. additional birth control details to be provided at screening. * documented molecular diagnosis of nalp3 mutations and clinical symptoms that are either untreated or insufficiently treated and require medical intervention. * patients under anakinra therapy or any other il-1 blocking therapy, whose clinical symptoms improved under treatment and are willing to discontinue that therapy until a relapse becomes evident. * patients with a very severe characteristics requiring oral prednisone are eligible if the dose is stable (≤ 0.4 mg/kg/day or ≤ 20 mg/day, whichever is lower) for at least 1 week prior to the screening visit. steroid therapy may be tapered during treatment with acz885 at the discretion of the investigator. * parents' or legal guardian's written informed consent (patient's informed consent for ≥ 18 years of age) and child's assent, if appropriate, are required prior to study participation. exclusion criteria: * participation in any clinical trial investigation (except trials with anakinra) within 4 weeks prior to dosing or longer per local regulation * antiinflammatory therapy with colchicine, chlorambucil, dapsone, azathioprine, mycophenolate mofetil, within 3 weeks prior to dosing. therapeutic antibodies (e.g. anti-tnf-alpha antibodies) must be discontinued at least 60 days before dosing. * donation or loss of 400 ml or more of blood within 8 weeks prior to dosing. * a past personal or close family medical history of clinically significant ecg abnormalities or prolonged qt-interval syndrome. * history of * immunocompromise, including a positive hiv result. * positive hepatitis b surface antigen or hepatitis c test result. * drug or alcohol abuse within the 12 months prior to dosing. * tuberculosis. * renal transplant. * evidence of lymphoma. * active medical condition preventing participation in the study such as infection, poorly controlled diabetes etc. * no live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.

Keywords: acz885 nalp3 mutations interleukin-1beta muckle-wells syndrome
trexima and relpax gastric scintigraphy inside and outside a migraine

Conditions: Migraine Disorders

Summary: an evaluation of tablet disintegration and absorption and gastric transit of sumatriptan and naproxen sodium from a trexima tablet and eletriptan from a relpax 40mg tablet.


Eligibility criteria:
inclusion criteria: * consented males and nonpregnant females using adequate contraception, between 18 and 55 years of age, with at least 1-6 migraines per month for past 6 months. subjects will be excluded for confirmed or suspected ischemic heart disease, uncontrolled hypertension at screening; a history of epilepsy or structural brain lesions which lowered the convulsive threshold; confirmed or suspected cardiovascular, cerebrovascular, peripheral vascular, congenital heart disease, or ischemic bowel disease; impaired hepatic or renal function; basilar or hemiplegic migraine. other exclusion criteria included use of a monoamine oxidase inhibitor within 2 weeks before screening; ergot prophylactics in past 3 months; anticoagulants; smoking more than 10 cigarettes/day, evidence of alcohol or substance abuse; gi bleeding disorders, inflammatory bowel disease; or any concurrent medical or psychiatric condition that in the investigator's opinion could affect interpretation of efficacy or safety information or which otherwise contraindicated participation in the study.

Keywords: combination product, sumatriptan succinate, naproxen sodium, absorption, pharmacokinetics, disintegration, gastric transit, gastric scintigraphy
characterization of vaginal, urinary and fecal microbiomes in women with recurrent urinary tract infections

Conditions: Urinary Tract Infections; Menopause

Summary: the objectives are to evaluate whether variations in vaginal and/or urinary and/or fecal microbiome predispose postmenopausal women to recurrent cystitis. this will be explored using comparison of microbiome profiles between those with recurrent uti compared to age-matched women without recurrent uti.

patients and age-matched control subjects will be recruited from the urogynecology clinic in hadassah mt scopus and the gynecology clinic, respectively. after assessment of inclusion and exclusion criteria and patient's consent to participate, a history intake (detailing demographics, medical history, risk factors for ruti etc.) and gynecological examination will be conducted as part of the usual assessment in the clinic. vaginal, urine and fecal samples for microbiome molecular analysis will be collected during clinic visits, given at least one month without antibiotics before samples collection, using agreed protocols and will be kept for future evaluation. urine will be collected for urinalysis and for a urine culture. in addition, urine cultures, as well as vaginal, urine and fecal samples for molecular analysis will be collected during an acute uti episode from the same patients. healthy patients (the control group) will be examined only once.

Eligibility criteria:
patients' inclusion criteria: * menopausal status * two or more documented, culture-positive infections in the last six months or ≥3 infections in the last year patients' exclusion criteria * neurogenic bladder condition * known immunodeficiencies * usage of antibiotics or probiotics within the previous month * known renal calculi or anatomic malformations control subjects- inclusion criteria: * menopausal status * sterile urine cultures, normal urinalysis, and negative sexually-transmitted pcr urine assay control subjects- exclusion criteria: - a prior history of utis or other urologic abnormalities.