Kornimate/medical-research-clean huggingface dataset:
correlating brain tissue oxygen and regional cerebral oximetry

Conditions: Stroke

Summary: controversy surrounds the use of regional cerebral oximetry (rso2) as a measure of true cerebral oxygenation because of extracranial signal contamination and unmeasured confounding of cerebral a:v ratio. the measurement of brain tissue oxygen (pbro2) has been used in routine neurosurgery and has been shown to reliably demonstrate cerebral hypoxia following severe head injury. it is the most direct measure of cerebral oxygenation. here, we test the hypothesis that there is a correlation between pbro2 and rso2 under conditions of varying inspired oxygen fraction and the varying partial pressure of carbon dioxide in arterial blood in uninjured, normal human brain. patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia will be recruited following written informed consent obtained by a study team member during their preoperative evaluation. bis and rso2 optodes will be applied, before induction of anesthesia, by a single researcher on both sides of the patient's forehead, as recommended by the manufacturer. general anesthesia will be maintained by total intravenous anesthesia (tiva) with a combination of propofol (80-150 mcg/kg/min) and remifentanil (0.05-0.1 mcg/kg/min) targeted to a bispectral index range 40-60 (bis; covidien, boulder, co). following craniotomy, the licox probe will be placed under direct vision into an area of normal brain within the tumor excision canal by the attending neurosurgeon. during a pause in surgery fio2 and minute ventilation will be sequentially adjusted to achieve the following pairs of ventilation set points: 1) fio2 0.3 and paco2 30mmhg, 2) fio2 1.0 and paco2 40mmhg. after ≥5 minutes at each set point fio2, paco2, rso2 and pbro2 will be recorded as a "snap-shot". a sample size of 15 achieves an 80% power with a one-sided type i error of 5% to detect a positive correlation of 0.6 (from the null hypothesis of no correlation) between changes in pbro2 and changes in rso2 subsequent on alterations made in ventilation strategy. correlation will be measured using pearson's correlation. p values \< 0.05 will be considered statistically significant.


Eligibility criteria:
inclusion criteria: * patients who are scheduled for elective removal of secondary cerebral metastases under general anesthesia. exclusion criteria: * patients will be excluded if they refuse to give consent, have evidence of elevated intracranial pressure on preoperative ct scan, have coagulopathy, are taking therapeutic agents known to increase bleeding risk, have a history of cardiovascular disease, cerebrovascular disease, suffer from respiratory failure, or are not fluent english speakers.
virtual reality analgesia for pediatric burn survivors

Conditions: Pain, Acute

Summary: many children with large severe burns report severe pain during burn wound cleaning. the current study explores whether adjunctive immersive virtual reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.

all patients always receive their usual pain medications. using a within-subjects, within-wound care design, in the current study, pediatric patients being treated for severe burn injuries will receive music distraction during some portions of their wound care (active comparator condition), and they will receive what we predict will be an unusually strong distraction, immersive virtual reality (the experimental treatment) during other comparable portions of the same wound cleaning sessions. during virtual reality, each patient will look into virtual reality goggles, and will play a simple cartoon-like virtual reality game snowworld during burn wound cleaning. after each wound care session, the patient will rate how much pain they experienced during wound care during no vr (music only) compared to how much pain they experienced during wound care during virtual reality, on each study day, for up to 10 study days per patient. treatment order randomized.

Eligibility criteria:
inclusion criteria: * compliant and able to complete subjective evaluations, * a minimum of 10% of total burned surface area, * no history of psychiatric (dsm-iii-r axis i) disorder(s), * not demonstrating delirium, psychosis or any form of organic brain disorder, * able to communicate verbally in english or spanish, * admitted to utmb/shriners, 6-17 years of age. exclusion criteria: * no wound cleaning sessions required. * less than 10% of total burned surface area. * history of psychiatric (dsm-iii-r axis i) disorder(s). * demonstrating delirium, psychosis or organic brain disorder. * unable to communicate verbally in english or spanish. * history of significant cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal, or genitourinary impairment. * receiving prophylaxis for alcohol or drug withdrawal, * developmental disability, younger than 6 years; older than 17 years, * burns of eyes, eyelids or face so severe they preclude the use of vr, * worst pain intensity of less than 5 on a 0 to 10 scale, during baseline no vr wound care day 1.

Keywords: virtual reality pain opioid pediatric burn wound care
frequency of endometrial cancer precursors associated with lynch syndrome

Conditions: Lynch Syndrome; Endometrial Cancer; Endometrial Hyperplasia; Mismatch Repair Deficiency; Microsatellite Instability

Summary: given that there is a significant prevalence of lynch syndrome among patients with endometrial cancer (about 5% of patients with endometrial cancer), and given there is a known risk of endometrial cancer among patients with endometrial hyperplasia (40% risk of pre-existing occult cancer with endometrial intraepithelial neoplasia), it is hypothesized that a diagnosis of endometrial hyperplasia may herald on-going risk of harboring a lynch syndrome gene mutation. the purpose of this study is to examine endometrial hyperplasia specimens and compare the frequency of lynch syndrome gene mutations between endometrial hyperplasia and endometrial cancer subjects. this will provide a rationale and opportunity for earlier screening, and reduce colon cancer morbidity and mortality secondary to the lynch syndrome gene.

this is an observational cohort study. tissue specimens obtained that have been labeled with the diagnosis of endometrial hyperplasia will be identified and their chart reviewed for demographic date of age, race, body mass index, and co-morbidities. the specimen will then be tested via immunohistochemistry for the mismatch repair proteins mlh1, pms2, msh2, or msh 6. their absence is indicative of lynch syndrome. statistical analysis will then be performed to compare the incidence of lynch syndrome in endometrial hyperplasia with lynch syndrome in endometrial cancer.

Eligibility criteria:
inclusion criteria: * appropriate specimen, hysterectomy or biopsy with final labeled diagnosis of endometrial hyperplasia of any grade exclusion criteria: * any specimen that is later associated with endometrial cancer in subsequent pathology exam

Keywords: lynch syndrome endometrial hyperplasia endometrial cancer immunohistochemistry mismatch repair
myotubular myopathy event study

Conditions: X-linked Myotubular Myopathy

Summary: x-linked myotubular myopathy (xlmtm), a form of centronuclear myopathy (cnm) is the result of a mutation in the mtm1 (myotubularin) gene which leads to altered myotubularin. myotubularin is essential for optimum muscle function. to date, over 100 mutations have been described resulting in a range of disease onset and symptom severity. the early onset form presents with neonatal hypotonia, muscle weakness, respiratory distress and an ongoing requirement for continuous ventilatory support with the inability to maintain a sitting position once placed. males with both later onset and milder symptoms usually do not require ongoing ventilatory support, achieve a higher maximal motor function with ability to sit when placed and even walk, and have improved survival rates. males with xlmtm may experience complications (events) at birth and throughout their lifetime. the goal of the study is to identify the number of events over twelve months in males with genetically confirmed xlmtm. parents or affected individuals over the age of 18 years who are able to access telephone will provide answers to an established event survey to evaluate the frequency and types of events. emergency department, hospital admissions and mortality will be confirmed by obtaining medical reports. the investigators hypothesize that there will be no association between the frequency of events and markers of clinical severity including the need for ventilatory support at birth, current level of ventilatory support (no support, support less than 12 hours, support more than 12 hours) and current motor function (walking, sitting without support, inability to sit without support).


Eligibility criteria:
inclusion criteria: * males with a confirmed mtm1 mutation or * males with a muscle biopsy consistent with myotubular myopathy and family history consistent with x-linked inheritance and * english-speaking parent/guardian of a living male child or a decisionally impaired adult or english-speaking affected male over 18 years of age who can access telephone * signed study consent * enrolled in the congenital muscle disease international registry (cmdir) exclusion criteria: * males with only a clinical diagnosis of xlmtm but without family history of xlmtm * an affected male who has a genetically confirmed form of centronuclear myopathy (cnm) that is not caused by a mutation in the mtm1 gene * females with mtm1 due to the limited number of females affected and the variability of clinical presentation

Keywords: cmdir (congenital muscle disease international registry) x-linked myotubular myopathy centronuclear myopathy myotubularin mtm1 gene mutation survival adverse event disease complication hospital admission emergency room visit motor function respiratory function natural history study
efficacy and safety study of benralizumab in adults and adolescents inadequately controlled on inhaled corticosteroid plus long-acting β2 agonist

Conditions: Asthma

Summary: the purpose of this study is to determine whether benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ics-laba with or without oral corticosteroids and additional asthma controllers.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. female and male aged 12 to 75 years, inclusively, at the time of visit 1 3. history of physician-diagnosed asthma requiring treatment with medium-to-high dose ics (\>250µg fluticasone dry powder formulation equivalents total daily dose) and a laba, for at least 12 months prior to visit 1. 4. documented treatment with ics and laba for at least 3 months prior to visit 1 with or without oral corticosteroids and additional asthma controllers. the ics and laba can be parts of a combination product or given by separate inhalers. the ics dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. for ics/laba combination preparations, the mid-strength approved maintenance dose in the local country will meet this ics criterion. exclusion criteria: 1. clinically important pulmonary disease other than asthma (e.g. active lung infection, copd, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, churg- strauss syndrome, hypereosinophilic syndrome) 2. any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: * affect the safety of the patient throughout the study * influence the findings of the studies or their interpretations * impede the patient's ability to complete the entire duration of study 3. acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

Keywords: asthma, bronchial diseases, respiratory tract diseases, lung diseases, obstructive lung diseases
effect of methyl-sulphonyl-methane on osteoarthritis and cartilage

Conditions: Osteoarthritis

Summary: to delineate the effect of msm on osteoarthritis

objective: to delineate the effect of msm on osteoarthritis of large joints. design: randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. one hundred men and women, with hip and/or knee oa to be divided in 2 groups. intervention is either msm 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. outcomes measured are the western ontario and mcmaster university osteoarthritis index visual analogue scale (womac), patient and physician assessments and sf-36 (overall health-related quality of life).

Eligibility criteria:
inclusion criteria: * knee and hip oa * men and women \>45 years of age exclusion criteria: * any other type of arthritis * chronic pain syndrome * arthroscopic surgery in the past 8 months * intra-articular corticosteroidsin the past 8 months * hyaluronic acid injections in the past 8 months * narcotic pain killers use * renal or hepatic disease * body mass index (bmi) \>45 kg/m2 * cancer

Keywords: osteoarthritis cam treatments msm
eliquis (apixaban) regulatory post-marketing surveillance in clinical practice for venous thromboembolism (vte) treatment and prevention of recurrent vte

Conditions: Venous Thromboembolism

Summary: the primary objectives of this study is to estimate the real-world safety profile of eliquis in japanese venous thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of eliquis in japanese venous thromboembolism patients.


Eligibility criteria:
inclusion criteria: * patients who are initiating eliquis for the treatment of vte or prevention of recurrent vte for the first time exclusion criteria: * prior treatment with eliquis for nonvalvular atrial fibrillation or vte * patients initiating eliquis for the treatment of atrial fibrillation * off-label use of eliquis other protocol defined inclusion/exclusion criteria could apply
osteopathy and latent hypothyroidism

Conditions: Latent Hypothyroidism

Summary: this study evaluates the effectiveness of stimulating the neurological segments c8-th5 in patients with latent hypothyroidism. one half of the participants will receive an osteopathic manuel treatment in order to stimulate the relevant segments, the other half will receive no treatment.

patients with latent hypothyroidism show an increased hormone status in tsh and a normal hormone status in ft4. a study has shown that osteopathic treatment had positive effects to some symptoms in patients with latent hypothyroidism. the study was using the pain inventory as the instrument to measure the effect. in this study we want to evaluate the effectiveness of the treatment on the hormone status (tsh, ft4) the intervention group will receive a neurological osteopathic stimulation over 5 weeks. a parallel control group will not receive any therapy. a follow up blood screening (tsh, ft4) will be done. the results of both groups will be compared.

Eligibility criteria:
inclusion criteria: * latent hypothyroidism exclusion criteria: * factors that alter thyroxine and triiodothyronine binding in serum * increased thyroxin-binding globulin * decreased thyroxin-binding globulin * binding inhibitors * inherited salicylates * pregnancy * androgens * furosemide * neonatal state * anabolic steroids * free fatty acids * estrogens * glucocorticoids * phenytoin * hepatitis * severe illness * carbamazepine * porphyria * hepatic failure * nonsteroidal antiinflammatory drug (variable, transient) * heroin * nephrosis * heparin * methadone * nicotinic acid * mitotane l-asparaginase * 5-fluorouracil * serms (e.g., tamoxifen, raloxifene) * perphenazine * spinal pathologies
a brief case management intervention for people involuntarily admitted to a psychiatric hospital

Conditions: Psychiatric Disorder; Involuntary Psychiatric Hospitalization

Summary: the goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. the main questions it aims to answer are: * is the case management intervention acceptable and feasible? * what are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care? participants will be asked to take part in: * the five sessions of the case management intervention; * two evaluation sessions (pre and post-intervention); * a final in-depth semi-structured interview (optional).


Eligibility criteria:
inclusion criteria: * to have been involuntarily admitted by a medical doctor * to be aged between 18 and 65 years exclusion criteria: * patients unable to provide written consent due to a lack of discernment * patients unable to speak french well enough to participate in the study without the help of an interpreter

Keywords: coercion involuntary admission personal recovery case management psychiatry
an open label positron emission tomography (pet) study of gsk618334 in healthy male subjects using 11c-phno as pet ligand

Conditions: Substance Dependence

Summary: the purpose of this study is to investigate the relationship between the plasma concentrations of the study drug and the amount of the study drug bound to the d3 receptors of the brain after dosing of a new compound gsk618334.

this imaging study will be an open label, non-randomised pet receptor occupancy study using healthy male volunteers. the time course and degree of d3 receptor occupancy (ro) after single doses of gsk618334 will be determined using 11c-phno as a pet ligand labeling dopamine receptor. the pk/pd relationship between plasma concentrations of gsk618334 and d3 ro will be described. potential relationships between d3 ro and functional magnetic resonance imaging (fmri) endpoints will be assessed as an exploratory aim.

Eligibility criteria:
inclusion criteria: * healthy, male subjects aged between 30 and 55 old inclusive. * normal body weight. * normal ecg and vital signs. * agree to use acceptable contraceptive methods required. * capable of giving written informed consent. exclusion criteria: * smoker or uses other nicotine-containing products. * certain medical conditions including heart disease, neurological disease, gastrointestinal disease, kidney or liver dysfunction - abnormal laboratory tests. * certain psychiatric conditions and use of certain psychoactive drugs . * positive blood alcohol or urine drug test. * alcohol intake over 14 drinks per week. * participation in another drug trial within 30 days or a study involving significant radiation exposure. * donation of more than 450 ml blood within the 56 days. * family history of cancer (one or more first-degree relative diagnosed before the age of 55 years old). * having cardiac pacemaker or other electronic device. * suffers from claustrophobia or feels that he will be unable to lie still on his back in the pet camera.

Keywords: positron emission tomography addiction
effects of exercise in patients with coronary artery disease aged 80 years or older

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to investigate the effects of exercise for patients with coronary artery disease (cad) aged 80 years and older, with special reference to maximum aerobic capacity, muscle endurance, physical functioning, level of physical activity, health related quality of life, anxiety, depression and endothelial function, compared to a control group.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute coronary artery disease * aged 80 years or older exclusion criteria: * inability to understand or speak the swedish language * serious physical or psychological disease interfering with participation in an exercise intervention * patients are already exercising three times or more/week

Keywords: coronary artery disease elderly exercise exercise-based cardiac rehabilitation