Kornimate/medical-research-clean huggingface dataset:
a study of imatinib and valproic acid in patients with chronic myelogenous leukemia (cml)

Conditions: Chronic Myelogenous Leukemia

Summary: the aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.

the aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal. briefly, patients with cml who are taking imatinib and have been found to have a plateau in their level of the bcr-abl transcript will be eligible to participate in the study. valproate will then be added to the imatinib, and subsequent bcr-abl transcripts will be monitored to see if the addition of valproate produced a further reduction. patients will be monitored for efficacy and toxicity.

Eligibility criteria:
inclusion criteria: * all patients, 18 years of age or older, with a diagnosis of cml. * patients must have a life expectancy of at least 12 weeks. * patients must have an ecog performance status of 0-2. * patients must sign an informed consent. * patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and sgot or sgpt \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal. * patients with cml in chronic phase on imatinib as first line therapy who fulfill the following criteria: * the patient has at least two tests for quantitative reverse transcriptase polymerase chain reaction (rt-pcr) for bcr-abl (peripheral blood or bone marrow aspirate). the results of these tests should demonstrate a relative plateau in the effect of imatinib on the detected level of the transcript (i.e. there should less than a ½ log difference between the last two values). note: patients will be eligible if the more recent study is greater than the previous study by any value. * the last two quantitative rt-pcr studies should be at least 3 months apart. * the patient should have received at least 9 months of imatinib since the diagnosis of cml. * the patient is tolerating imatinib without any grade 3 or greater toxicity. exclusion criteria: * pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception. * patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial. * patients who have a hypersensitivity to valproic acid, derivatives, or any component of the formulation. patients with hepatic disease or significant impairment, or urea cycle disorders

Keywords: cml chronic myelogenous leukemia inst 0901 imatinib valproic acid gleevec
quality of life influencing factors

Conditions: Paroxysmal Atrial Fibrillation

Summary: background: quality of life is impaired in patients with paroxysmal atrial fibrillation. the purpose of this study is to explore the mediating effects of self-efficacy, coping, depression, and anxiety on the quality of life of patients with paroxysmal atrial fibrillation. methods: it is a cross-sectional study trial. this study aims to enroll 100 patients with paroxysmal atrial fibrillation. illness perceptions (brief illness perceptions questionnaire; bipq), coping styles (carver brief-cope scale; b-cope), depression patient health questionnaire-9 ,phq-9),anxiety (the generalized anxiety disorder questionnaire, gad 7) and quality of life (12-item short form health survey,sf12) will be analysed. this study intends to use correlation analysis and mediation analyses to assess the mediating effects of self-efficacy, coping, depression and anxiety on the quality of life of patients with paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years; 2. af diagnosis, based on a 12-lead ecg and cardiologist-led examination following the 2016 esc guidelines for the management of atrial fibrillation 3. paroxysmal af diagnosis given by a cardiologist according to the conversion back to the normal sinus rhythm occurs spontaneously within a week 4. ability to read and write in chinese. exclusion criteria: 1. severe complications such as unstable coronary artery disease, heart failure with severe systolic dysfunction(ejection fraction≤35%) 2. af soon after thoracic surgery; 3. malignant disease with a 1-year survival rate or a terminal illness diagnosis; 4. a diagnosed psychiatric condition that interfered with participation (including severe depression, bipolar disorder, psychotic illness of any type, dementia, acute suicidality, severe personality disorder) 5. participation in another study 6. cognitive impairment interfering with their ability to participate in the study
detecting lung's closing pressure by capnography

Conditions: Atelectasis

Summary: general anesthesia is associated with loss of pulmonary functional residual capacity and the consequent development of atelectasis and closure of the small airway. mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain, inducing a local inflammatory response in atelectatic lung areas known as ventilatory-induced lung injury. this phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes them to hypoxemic episodes that can persist in the early postoperative period. lung recruitment maneuvers restore the functional residual capacity and, therefore, protect the lungs from lung injury. a key issue in this kind of treatment is detecting the lung's closing pressure in order to maintain the end-expiratory pressure above such a limit.

this is a prospective and observational study designed to measure the lung's closing pressure. the investigators will study 20 mechanically ventilated patients scheduled for mediastinoscopy surgery under general anesthesia. lung mechanics and capnography will be assessed during surgery. a slow pressure-volume curve will be automatically performed by the ventilator, and the small airway closing pressure will be determined as the inflection point in the alveolar slope of the pressure-co2 and volume-co2 curves. then, a lung recruitment maneuver will be applied following a descending positive end-expiratory pressure trial to determine the lung's closing pressure. the investigator will see if the lung's closing pressure found with these two techniques is similar.

Eligibility criteria:
inclusion criteria: * age \> 17 years ole * programmed surgery exclusion criteria: * pregnancy * no programmed surgery * hemodynamic instability * severe copd * acute respiratory infection

Keywords: carbon dioxide mechanical ventilation
twitter based social support for hispanic and black dementia caregivers

Conditions: Loneliness; Emotional Stress

Summary: the prevalence of dementia is higher in hispanics and african americans than non-hispanic whites. moreover, dementia caregivers often experience loneliness as well decreased health status. the expansion of social media use among hispanics and african americans, particularly twitter - a short message service - offers great promise for improving social support. this study aims to evaluate changes of discussion topics, sentiment and networking styles (i.e., number of followers) among anonymous followers of our two twitter networks; the african american/black dementia caregiver group and the hispanic dementia caregiver group.

the study will utilize twitter networks to post a daily message for dementia caregivers for a year, and set up a monthly group chat.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * black or hispanic, living in the u.s. including the u.s. territories * a dementia caregiver with any duration, able to speak english or spanish/bilingual * must agree to terms of conditions of use and privacy policy and rules of one of the two dementia caregiver network (hispanic @dcnh, black @dcnaab), the twitter user agreement of the terms of service, twitter privacy policy and twitter rules including intellectual property, violence, misconduct, abuse behavior, private information and spam and security * use a smartphone or a feature phone (i.e., a cell phone with text messaging) exclusion criteria: * do not have de-identified twitter account, children, not a dementia family caregiver

Keywords: family caregivers dementia
a study of lymphoseek® as a lymphoid tissue targeting agent in pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping

Conditions: Rhabdomyosarcoma; Melanoma

Summary: open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of lymphoseek with optional comparison to vbd in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. subject age will range from neonatal through 17 years.


Eligibility criteria:
inclusion criteria: * the subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted * subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate * the subject is clinically node negative (cn0) at the time of screening * age \< 18 years * male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study * female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study exclusion criteria: * the subject has had preoperative radiation therapy * has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ilm) procedure * has a known allergy to dextran or vbd (if intended to be used) * has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator * before the administration of lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
pharmacokinetics and safety of rv521 formulations

Conditions: Respiratory Syncytial Virus Infections

Summary: the main aims of the study are to assess the pharmacokinetics and safety of single doses of rv521 administered as two different formulations


Eligibility criteria:
inclusion criteria: * willing to comply with protocol defined contraception requirements * in good health with no history of major medical conditions * a body mass index (bmi) of 18-25 kg/m\^2, inclusive exclusion criteria: * evidence of any clinically significant or currently active major medical condition * positive test for hepatitis b surface antigen (hbsag), hepatitis c antibody (hcv ab), or human immunodeficiency virus antibody (hiv ab) at screening * not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, otc, herbal, vitamins/minerals etc) and specified food and drink products
dose-finding study to investigate the safety and immunogenicity of two vaccinations with fsme immun new in healthy volunteers aged 6 to 16 years.

Conditions: Tick-borne Encephalitis

Summary: the purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a tbe vaccine will be investigated in healthy children aged 6 to 16 years.


Eligibility criteria:
inclusion criteria: male and female children will be eligible for participation in this study if: * they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday); * they are clinically healthy; * their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent; * their legal representative agrees to keep a volunteer diary. for safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start: * negative pregnancy test at study start; * they agree to employ adequate birth control measures for the duration of the study. exclusion criteria: children will be excluded from participation in this study if they: * have a history of any previous tbe vaccination; * have a history of tbe infection or show evidence of a latent tbe infection (as demonstrated by screening elisa \> 126 vieu/ml and / or neutralization test \> 1:10); * have a history of allergic reactions, in particular to one of the components of the vaccine; * have received antipyretics within 4 hours prior to the first tbe vaccination; * suffer from a disease that cannot be effectively treated or stabilized; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions; * suffer from chronic, degenerative and / or inflammatory disease of the central nervous system; * are known to be hiv positive (a special hiv test is not required for the purpose of the study); * suffer from a febrile illness at study entry; * have a history of vaccination against yellow fever and / or japanese b-encephalitis; * are participating simultaneously in another clinical trial. * if female, are pregnant or breast feeding volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body temperature \>= 38° c, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal.
reliability, validity and responsiveness of the upright motor control test in patients with stroke

Conditions: Stroke

Summary: impaired motor function is common after stroke. individuals with stroke often exhibit synergic pattern that disturb daily function. it is crucial to identify the movement impairment in the clinical settings. upright motor control test (umct) is one of the tests developed to assess the selective movement control and functional strength in people with central nervous disorders. it can be used to reflect the impairment of motor function and evaluate changes of performance after treatment. yet is little to know the clinimetrics of the umct on clinical utility. to date, only few researches explore that umct has some construct and criterion validity. therefore, this study aims to 1) establish the inter-rater reliability to administer the umct. 2) explore the correlation between the fugl-meyer assessment of motor recovery after stroke (fma) and umct. 3). investigate whether the umct is able to predict the walking ability in patients with stroke.


Eligibility criteria:
inclusion criteria: * first-ever, unilateral cerebral stroke within one month * being able to maintain standing for more than 10 seconds exclusion criteria: * could not follow commands * deformity or fracture of lower limb * less than 20 years old
a prospective analysis of the effect of therapeutic hypothermia after cardiac arrest

Conditions: Cardiac Arrest

Summary: therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest. few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms. our institution, a large community teaching hospital, instituted a therapeutic hypothermia protocol in november 2006 for all resuscitated cardiac arrest patients. the investigators seek to determine the mortality rate of our protocol and compare our complication rates with those of previously published studies.

the use of therapeutic hypothermia has been shown to have a beneficial effect on neurologic outcomes of patients resuscitated from cardiac arrest in a limited number of clinical sites. based on available data, current recommendations from the american heart association include a level 2a endorsement of therapeutic hypothermia for cardiac arrest from ventricular fibrillation with persistent coma, and a level 2b recommendation for cardiac arrest from any other rhythm. to date there have been no formal studies presented that demonstrate an improvement in outcome when a hypothermic protocol is implemented in a community hospital. the investigators plan to prospectively collect data on patients enrolled in the therapeutic hypothermia protocol to evaluate clinical outcomes and compare these outcomes with historic controls, with the hypothesis that patients enrolled in the hypothermic protocol will have improved neurologic outcomes.

Eligibility criteria:
inclusion criteria: * any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission. exclusion criteria: * hypotension (sbp \<90), initial temperature \< 30 °c, trauma, primary intracranial event, or active coagulopathy.

Keywords: therapeutic hypothermia
orange juice and glycaemic control in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the evidence on the consumption of 100% orange juice in people with type 2 diabetes is highly variable and largely out-of-date, with a few studies reporting acute negative glycaemic effects when 100% orange juice is drunk with or without a meal. the aim of the project is to study the impact of the intake of a single serving of 100% orange juice on glycaemic control in male patients with pre-existing type 2 diabetes mellitus. in addition, immunological parameters and alzheimer disease related biomarkers will be assessed to examine the chronic inflammatory state of these patients


Eligibility criteria:
inclusion criteria: * inclusion criteria: individuals (aged 25-75 years) with up to 8 years of t2dm, according to ada criteria (two-hour plasma glucose ≥200 mg/dl (11.1 mmol/l) during ogtt. the test should be performed as described by the who, using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water; or hba1c \> ≥6.5% (48 mmol/mol)). exclusion criteria: * pregnancy, * participants on exogenous insulin therapy, * hba1c \>8.5%, * bmi \ 35 kg/m², * regular smokers (\>1 cigarette per day), * participants with established cardiovascular disease, * neurological disease, * cancer, * renal disease. * participants who are unwilling to consume any of the standard foods/drinks
bluewind medical reprieve system for the treatment of pnp

Conditions: Peripheral Neuropathy

Summary: the current study will evaluate the safety and performance of the bluewind medical reprieve system for the treatment of chronic painful peripheral neuropathy.

the bluewind reprieve system is a neurostimulator consisting of an implant and external components. the system is intended for home care use. the chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. the stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. male or female aged 18 - 80. 3. patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires. 4. diagnosis of chronic neuropathic pain due to peripheral neuropathy. 5. documented pain attributed to neuropathy for at least 6 months. 6. pain intensity with an average daily vas score of at least 6, demonstrated by 2-3 ratings per day across 7 days. 7. patient refractory to conservative treatments including pain medication, for at least 6 months. 8. stable pain medication for at least 4 weeks prior to study enrollment. exclusion criteria: 1. previous participation in another study with any investigational drug or device within the past 90 days. 2. any active implant (cardiac or other). 3. any metal implant in the area of bluewind device implantation site. 4. current pregnancy or attempting to get pregnant (female patient). 5. any clinically significant neurologic disorders (except pnp). 6. any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study. 7. patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases. 8. severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.

Keywords: pnp stimulation peripheral neurostimulation
database of clinical data for individuals with variants in the irf2bpl gene

Conditions: Autism Spectrum Disorder; Movement Disorders; Seizures; Dystonia; NEDAMSS

Summary: this protocol serves as a data collection tool for individuals with variants (missense, nonsense, frameshifts) in the irf2bpl gene (mim 611720), which causes neurodevelopmental regression, seizures, autism and developmental delay (nedamss, mim 618088) and may be involved in other neurodevelopmental presentations. this information will be analyzed to develop a better understanding of the findings and progression of symptoms in individuals with variants in the irf2bpl gene.

neurodevelopmental regression, abnormal movements, loss of speech, and seizures (nedamss) is caused by changes in the irf2bpl gene. variants in the gene can also lead to other neurodevelopmental presentations. due to the limited number of cases that have been described to date, clinicians may have a limited understanding of what types of symptoms can develop in affected individuals and at what age. the purpose of the study is to gather clinical information about progression, treatments and outcomes for patients with variants in irf2bpl. the investigators will collect information about medical history, growth, development, treatments and the results of previous genetic tests. in some cases, the investigators may also collect tissue samples. this is a non-interventional study that will expand the current understanding of the range of health concerns that can be seen in individuals with changes in the irf2bpl gene by collecting medical information and samples from a larger group of affected individuals.

Eligibility criteria:
inclusion criteria: * living or deceased individuals with variants in the irf2bpl gene exclusion criteria: * none

Keywords: irf2bpl nedamss dystonia movement disorder seizures