Kornimate/medical-research-clean huggingface dataset:
comparison of dialysis strategies in critically ill patients with acute renal failure

Conditions: Dialysis; Acute Renal Failure

Summary: the goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. patients are treated with either continuous dialysis or hemofiltration. outcome measures are death, restitution of renal function, days on icu, hemodynamic stability, dialysis efficiency.

the goal of the present study is the comparison of different renal replacement strategies in critically ill patients with acute renal failure on the intensive care unit. in a prospectively randomized clinical study patients are treated with either continuous dialysis (sled) or continuous hemofiltration (cvvhd). 200 patients should be included in the study (n=100 each). the primary outcome is death at icu, secondary outcome measures are restitution of renal function, days on icu, hemodynamic stability, dialysis efficiency.

Eligibility criteria:
inclusion criteria: * patients 18 years or older * written informed consent * no pre-existing dialysis dependency exclusion criteria: * minors / children * no consent * severe electrolyte disturbances which necessitates special dialysis therapy
exploring racial disparities in sleep health and neurocognitive function

Conditions: HIV Dementia

Summary: despite longer life expectancies due to combination antiretroviral therapy (cart), the prevalence of hiv-associated neurocognitive disorders (hand) persists thus affecting 52% of the hiv population. poor sleep quality is commonly reported in older adults and has been related to neurocognitive impairments. this is concerning given studies have shown that up to 75% of adults with hiv experience poor sleep, and by 2020, 70% of adults with hiv will be age 50 and older. it is important to examine sleep quality as it relates to neurocognitive function and hand in older adults with hiv given its negative impact on cart adherence. compared to whites with hiv, african americans (aa) are disproportionately affected by hiv and are more likely to experience poor sleep quality. this primary goal of this 1-year cross-sectional study is to examine racial differences in sleep quality and neurocognitive function among 60 african americans and whites with hiv (age 50+).

this study is designed with two aims: aim 1a: to explore differences in sleep health between older hiv+ aa and whites. 1b: to explore differences in domain-specific neurocognitive impairments between older hiv+ aa and whites. aim 2a: to explore the relationship between sleep health and neurocognitive function. 2b: to explore the relationship between sleep health and cart adherence. 2c: to explore mediation effects of cart adherence between sleep health and neurocognitive function. this is the first study to explore racial disparities in sleep health and neurocognitive function, using eeg/erp metrics, among older hiv+ adults. there are two phases in this study: phase i which consists of neurocognitive testing and sleep assessments with actigraphy, and phase ii which consist of a 20-30 min eeg. measurements of electrical brain activity will be captured while participants engage in an attention network test which measures executive function, attention, and speed of processing.

Eligibility criteria:
inclusion criteria: * hiv+ * identify as aa or white * 50 years old or older * speak english exclusion criteria: * alzheimer's disease or dementia * severe neurocognitive impairment (\>7 errors on the short portable mental status questionnaire) * deaf or blind * currently undergoing radiation/chemotherapy * brain trauma with loss of consciousness greater than 30 minutes * a learning disability * significant neuromedical comorbidities (e.g., schizophrenia) * currently taking efavirenz * moderate to severe sleep apnea * restless leg syndrome * narcolepsy * left handedness

Keywords: sleep neurocognitive disorders hiv/aids aging
tomotherapy as primary radiotherapy for multipule brain metastases

Conditions: Brain Metastases

Summary: this clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.

this is a single-arm, single center, phase ii trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).

Eligibility criteria:
inclusion criteria:histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced mri or ct; the lesion number is no less than 3;kps ≥60,or kps ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; age: 18-75 years old; adequate organ function:wbc≥4.0x109/l, neu ≥ 1.5x109/l, hemoglobin ≥ 110 g/l, platelets ≥100 x109/l, totalbilirubin ≤ 1.5x uln, ast and alt ≤ 1.5x uln, bun and cr: within the normal range. exclusion criteria: other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia). unable or unwilling to comply with the study protocol.the expected survival time is less than 3 months. patients who are anticipated in other clinical trials of brain metastases. patients who has been treated with wbrt. pregnant patients or female patients whose hcg is positive. unsuitable to participate in study, that in the opinion of the treating physician.

Keywords: multiple brain metastases tomotherapy fractionated stereotactic radiotheray
inspiratory muscle training in individuals with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is a genetic disease that affects some organs of the human body. among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. with the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. the researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis, confirmed by the sweat test; * 14 - 25 years; * clinical stability; * absence of bacterial colonization for 4 weeks; * both sexes; exclusion criteria: * inability to perform the protocol established by the study; * present any intercurrence during data collection; * being unable to understand and / or perform procedures. * colonization during study participation; * patient hospitalization due to worsening of the clinical picture.

Keywords: cystic fibrosis quality of life posture
evaluation of microrna expression in blood and cytology for detecting barrett's esophagus and associated neoplasia

Conditions: Barrett's Esophagus; Gastroesophageal Reflux; Esophageal Adenocarcinoma

Summary: the primary purpose of this study is to test new methods to diagnose be in time before it turns into advanced cancer. once be is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. the two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. the investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microrna (mirna). in the future, measurements of microrna biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.

the investigators will collect serum, bile and esophageal cells (using cytology devices) from consenting subjects. the investigators have previously identified be specific mirna that will be tested on the cytology specimens. these are mirnas -192-5p, -215-5p and -194-5p. the investigators have also identified serum micrornas in whole serum and exosomes by sequencing to study further. the investigators will also evaluate mirna expression within biliary exosomes for the first time in patients with reflux related diseases.

Eligibility criteria:
inclusion criteria: * patient age: \> 18 years * ability to provide written, informed consent exclusion criteria: * pregnancy or planning a pregnancy * history of nasal, esophageal \& gastric surgery * history of recurrent epistaxis or nasal trauma * subjects with a history of unresolved drug or alcohol dependency * inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc. * subjects with inadequate cytology specimens will not undergo repeat test and will be excluded from the study * inability to provide written informed consent * inability to discontinue drugs such as plavix * advanced chronic liver disease * severe uncontrolled coagulopathy * active cancer in any organ over the past 3 years.

Keywords: blood cytology esophagus microrna
regulatory avamys nasal spray pms

Conditions: Rhinitis, Allergic, Perennial and Seasonal

Summary: non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of avamys nasal spray administered in korean patients according to the prescribing information. avamys is a registered trademark of the gsk group of companies.


Eligibility criteria:
all subjects must satisfy the following criteria. 1. subject who is treated with avamys nasal spray for the first time. 2. subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years. 3. subject who is considered to follow the pms protocol by an investigator. 4. subject who is contactable via telephone. 5. subject who is treated with avamys nasal spray according to its prescribing information. as considering the characteristic of the observational post marketing surveillance, the exclusion criteria is not strict. all investigators should prescribe avamys nasal spray according to prescribing information which approved in korea. all subjects must not satisfy the following criteria. 1. subject who has hypersensitivity to its ingredients. 2. as corticosteroids can slow the healing of wounds, if a subject who has surgery on his/her nose recently, or has a sore in his/her nose, or if his/her nose has been injured, the subject does not use avamys nasal spray until his/her nose has healed.

Keywords: avamys allergic rhinitis post marketing surveillance seasonal allergic rhinitis perennial allergic rhinitis (par)
pilot rct of a video-based intervention for suicide prevention

Conditions: Suicidal Ideation; Suicidal Behaviors; Suicide

Summary: the investigators will develop a brief video-based intervention for suicide prevention, called lifeplans. lifeplans will be tested in a pilot randomized controlled trial (n = 40) to examine its feasibility and acceptability. investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.

in this project, we propose to develop a new intervention, called lifeplans. lifeplans will consist of brief videos that highlight patients' experiences. episodes will cover these topics: 1) developing a personalized "life plan" to stay safe and restrict means, 2) clarifying valued life domains and related goals to improve hopefulness, 3) using informal problem solving to cope better with illness, 4) improving communication with family/friends to increase social support, and 5) adhering to primary treatments including pharmacotherapy and psychotherapy to promote illness management. lifeplans will be tested in a pilot randomized controlled trial (n = 40) to examine its feasibility and acceptability. investigators will recruit patients admitted to a psychiatric hospital for suicidal thoughts and behaviors who will receive the intervention for 4 weeks post-discharge. patients will be assessed at hospital baseline, 1 month post-discharge, and 6 months post-discharge.

Eligibility criteria:
inclusion criteria: * current psychiatric hospitalization for suicidal thoughts and behaviors * 18 years or older * ability to speak and read english * access to means for viewing videos (computer, tablet, smartphone) exclusion criteria: * current psychotic symptoms * current cognitive impairment

Keywords: psychiatric hospitalization
adjuvant use of neostigmine in sepsis and septic shock.

Conditions: Sepsis, Septic Shock

Summary: the inflammatory response represents an important, central component of sepsis. therefore, it is believed that blunting inflammation will decrease mortality. in vivo test series with mice that had undergone cecal ligation and puncture (recognized sepsis model), physostigmine salicylate significantly inhibited the release of various cytokines (tumor necrosis factor α, interleukin1β, and interleukin 6). these results were similar to those obtained by vagus nerve stimulation. in animal sepsis model using physostigmine not only decreased inflammation but also, diminished the decrease in blood pressure following infection. animals treated with the peripheral choline esterase inhibitor neostigmine showed no difference compared with physostigmine-treated animals. therefore, this study aims to investigate the efficacy of choline esterase inhibitors as adjuvant therapy in patients with sepsis or septic shock. outcome measures include: percentage reduction in procalcitonin blood level, percentage of patients achieving significant reduction in procalcitonin levels, mean sequential organ failure assessment score, percentage decrease in lactate dehydrogenase blood level, length of stay in hospital intensive care unit, and in hospital mortality.


Eligibility criteria:
inclusion criteria: * age 18-85 years. * patients diagnosed with sepsis or septic shock according to third international consensus definitions for sepsis and septic shock mentioned above. * patients who have ≥ 2 of the following four criteria plus documented infection: 1. fever ≥ 38 °c or hypothermia ≤ 36 °c. 2. tachycardia ≥ 100/min. 3. tachypnea ≥ 20/min or hyperventilation. 4. leukocytosis ≥ 12000/mm3 or leukopenia ≤ 4000/mm3 or ≥ 10% immature neutrophils in the differential count. exclusion criteria: * known hypersensitivity to choline esterase inhibitors. * known absolute contra-indications against choline esterase inhibitors such as, myotonic dystrophy; depolarization block by depolarizing muscle relaxants; intoxication by irreversibly acting cholinesterase inhibitors; closed craniocerebral trauma; obstruction in the gastrointestinal tract (mechanical constipation); obstruction in the urinary tract (mechanical urinary retention) * known relative contraindications against choline esterase inhibitors: bronchial asthma; bradycardia; av-conduction disturbances. * having undergone solid organ transplantation. * pregnant and lactating women. * participation in another clinical trial. * presence of primary or concomitant illness, impending death.
randomised study to compare the efficacy of azd6244 vs tmz

Conditions: Melanoma

Summary: the primary purpose of this study is to compare the efficacy of azd6244 (arry-142886) with temozolomide in patients with advanced melanoma


Eligibility criteria:
inclusion criteria: * diagnosed with late stage malignant melanoma * aged 18 or over * female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal exclusion criteria: * any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable) * participation in any other trial with an investigational product within the previous 30 days

Keywords: melanoma phase ii azd6244 temozolomide
faecal microbiota transplantation for patients with diabetes mellitus type 1 and severe gastrointestinal neuropathy

Conditions: Faecal Microbiota Transplantation (FMT); Diabetes Mellitus, Type 1; Gastrointestinal Neuropathy

Summary: a randomised, double-blinded and placebo-controlled intervention study. the study aim to evaluate the feasibility, safety and pilot-efficacy of faecal microbiota transplantation as a treatment of severe gastrointestinal neuropathy in patients with diabetes mellitus type 1.

diabetes type 1 may cause damage to nerve cells in the gut causing neuropathy that leads to changes in gastric and intestinal motility. this change predisposes to an abnormal amounts and composition of bacteria in the gut, probably leading to uncontrollable diarrhea and severely impaired quality of life. transferal of intestinal microbiota from a healthy donor to a patient is called faecal microbiota transplantation (fmt). fmt may potentially change the bacteria in the gut and reduce gastrointestinal symptoms. however, fmt may also have potential side effects, especially in persons with autonomic neuropathy and delayed transit through the gut.

Eligibility criteria:
inclusion criteria: adult (≥ 18 years old), male or female patients with dm1 for at least 5 years and average of or above 40 points in the questionnaire: gastrointestinal syndrome rating scale - irritable bowel syndrome version (gsrs-ibs). exclusion criteria: * inability to understand danish or the trial procedures * known or anticipated pregnancy * known severe renal insufficiency * antibiotic use in the prior 4 weeks * treatment with morphine * ongoing infection with clostridioides difficile or pathogenic intestinal bacteria or parasites * known gastrointestinal disease or gi infection * patients diagnosed with intestinal stricture * patients with other known disorder that can cause gastroparesis * patients with planned mr scan within 4 weeks * patients with pacemaker/icd * previous abdominal surgery * changes in medicine that affects the gi tract in the prior 4 weeks
multimorbidity life-course approach to myocardial health -a cardiac sub-study of the mrc national survey of health and development (nshd)

Conditions: Frailty; Cardiovascular Diseases

Summary: background the life course accumulation of overt and subclinical myocardial dysfunction contributes to older age mortality, frailty, disability and loss of independence. the medical research council national survey of health and development (nshd) is the world's longest running continued surveillance birth cohort providing a unique opportunity to understand life course determinants of myocardial dysfunction as part of myofit46-the cardiac sub-study of the nshd. methods and expected results the investigators aim to recruit 550 nshd participants of approximately 75 years+ to undertake high-density surface electrocardiographic imaging (ecgi) and stress perfusion cardiovascular magnetic resonance (cmr). through comprehensive myocardial tissue characterization and 4-dimensional flow the investigators hope to better understand the burden of clinical and subclinical cardiovascular disease. supercomputers will be used to combine the multi-scale ecgi and cmr datasets per participant. rarely available, prospectively collected whole-of-life data on exposures, traditional risk factors and multimorbidity will be studied to identify risk trajectories, critical change periods, mediators and cumulative impacts on the myocardium. conclusion by combining well curated, prospectively acquired longitudinal data of the nshd with novel cmr-ecgi data and sharing these results and associated pipelines with the cmr community, myofit46 seeks to transform our understanding of how early, mid and later-life risk factor trajectories interact to determine the state of cardiovascular health in older age.


Eligibility criteria:
inclusion criteria: * nshd study member. * who is still alive and agreed to take part in the study. exclusion criteria: * pacemaker. * implantable cardio defibrillator. * atrial fibrillation. * complete heart block. * severe asthma.
injection site pain comparison of excipient solutions

Conditions: Obesity

Summary: the purpose of this study is to investigate different solutions used to inject drugs under the skin. the solutions used in the study do not contain the drugs they will be used for, but they do contain excipients, which are inactive substances added to drug solutions to ensure the stability (shelf life and correct activity) of the drug product. the excipients are considered 'inactive substances' compared to the drug, but they may cause an undesirable effect at the injection site in the form of pain. however, their pain-causing potential has never been tested in a systematic way. the purpose of the study is to determine if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 12 different study products. these study products are excipient solutions, which are substances in medications next to the active substance. none of the 12 products include active medication. this study will be performed in 108 healthy male and female volunteers.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 to 69 years (both inclusive) at the time of signing informed consent. * body mass index (bmi) equal to or above 25.0 and below 30.0 kg/m\^2. * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg), and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant within 1 week of day 2 or is of childbearing potential and not using highly effective contraceptive methods. * any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. * glycated haemoglobin (hba1c) equal to or above 6.5 % (48 mmol/mol) at screening. * use of prescription medicinal products or non-prescription drugs or herbal products, except routine vitamins, topical medication (when not used in the abdominal area), contraceptives or occasional use of paracetamol (not allowed within 24 hours prior to trial product administration), within 14 days prior to day 1. * average intake of more than 21 units of alcohol per week for male subjects and more than 14 units per week for female subjects: 1 unit of alcohol equals approximately 250 ml of beer, 100 ml of wine, or 35 ml of spirits. * positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines \[including ecstasy\], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening and admission to the clinical research centre. * use of tobacco and nicotine products, defined as any of the below: * smoking more than 1 cigarette or the equivalent per day on average. * not able or willing to refrain from smoking and use of nicotine substitute products during the in-house period. * subject is not able to understand and read english or dutch, or subject is not able to understand and comply with the trial requirements.