Kornimate/medical-research-clean huggingface dataset:
psychological intervention for brain tumor caregivers

Conditions: Malignant Glioma; Anxiety; Caregiver Burden; Malignant Brain Tumor

Summary: this study is testing a supportive psychosocial intervention for caregivers of people who have malignant brain tumors such as gliomas or other high-grade primary brain tumors. this study was designed because caregivers of patients with malignant brain tumors often experience physical and psychological burdens caring for their loved ones. the purpose of this study is to find out whether a program offering psychological support can help caregivers learn effective coping methods during their loved one's treatment and make the experience of being a caregiver more manageable.

this study will be a prospective, randomized controlled trial to assess the efficacy of a caregiver-directed intervention designed to improve anxiety in caregivers of patients with malignant brain tumors, in comparison with caregivers who receive usual care. the aim of this study is to test the efficacy of this intervention in reducing distress in caregivers of patients with malignant brain tumors, in comparison with usual care. the study will be conducted in 120 caregivers.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * identified by study staff, a clinician, self, or a patient with a malignant brain tumor as the patient's primary caregiver * the patient is receiving care at the mgh cancer center * the patient was diagnosed with a malignant brain tumor within the past 6 months * able to speak and read in english * generalized anxiety disorder 7-item (gad-7) score ≥5 * participants may or may not be pregnant. exclusion criteria: * deemed inappropriate for the study by the patient's clinician or the study pi * participated in the pilot study of this caregiver intervention (df/hcc 18-426)

Keywords: malignant glioma caregiver anxiety caregiver burden psychological distress brain tumor
preventing cognitive decline

Conditions: Cognitive Decline

Summary: the study aims to understand the mechanisms and training effects of evidence-based body-mind training on improving cognitive performance and preventing cognitive decline.

subjective cognitive decline (scd), the self-reported perception of memory or cognitive problems, is a risk factor for the cognitive decline and development of alzheimer's (ad) and often happens in midlife. recently, few mind-body interventions have suggested promising effects in preventing cognitive decline. however, these interventions often require longer training time (months to years) to achieve modest benefits, making them less optimal for rapidly learning and achieving desirable outcomes. one mechanism for cognitive decline and ad may involve deficits in self-control networks, and autonomic nervous system (ans) and these deficits can be ameliorated through body-mind interventions. this study aims to investigate the modulation effects of a novel body-mind intervention on scd using an evidence-based preventive intervention - integrative body-mind training (ibmt).

Eligibility criteria:
inclusion criteria: * able to read/understand english * normal performance using standardized cognitive tests * self-reported decline in cognitive capacity such as memory loss * eligible for non-invasive fmri * willing to be randomized * free of any severe psychiatric diagnoses or medication that may affect participation exclusion criteria: * medical disorders or medications that affect the central and autonomic nervous system; or a positive pregnancy test result (females) * unable to provide consent or understand study procedures due to mental illness or cognitive limitations * previous meditation experiences * evidence of illicit drug use * participants for blood draws weigh less than 110 lbs * metal or metallic materials in the body such as pacemaker
real life safety and efficacy of vardenafil

Conditions: Erectile Dysfunction

Summary: in this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of levitra® in routine treatment of erectile dysfunction. the general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.


Eligibility criteria:
inclusion criteria: * any adult patient (\>/=18 years) with erectile dysfunction treated with levitra®. * patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study. exclusion criteria: * exclusion criteria must be read in conjunction with the product information (package insert).

Keywords: levitra erectile dysfunction taiwan
clinical assessment of gsk716155 for type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: a phase i/ii study to investigate the safety, pharmacokinetics and pharmacodynamics of gsk716155 in japanese subjects with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus diagnosed at least 3 months with fpg level \<=240mg/dl and hba1c between 6.5% and 10% inclusive. * must be diet controlled - or - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study. * must have a bmi:\<=35kg/m2, 20 to 70 years of age inclusive. * woman must be of non-childbearing potential. exclusion criteria: * positive test result for either syphilis, hbs antigen, hcv antibody, hiv antigen/antibody, or htlv-1 antibody. * clinically significant hepatic enzyme elevation. * history of metabolic disease other than t2dm. * previous use of insulin as a treatment for diabetes within 3 months. * history of severe gastrointestinal disease. * clinically significant cardiovascular disease. * significant renal disease as defined by screening lab test. * history of drug (including albumin or albumin containing agents) allergy. * history of alcohol or drug abuse. * donation of blood in excess of 400ml within previous 4 months. * previously received any glp-1 mimetic or any other albumin-containing products.

Keywords: glp-1 type 2 diabeted mellitus safety gsk716155 glp-1 receptor agonist tolerability pharmacokinetics pharmacodynamics
improved detection of myocardial fibrosis: a cardiovascular magnetic resonance imaging study

Conditions: Myocardial Diseases

Summary: myocardial fibrosis, or scarring, is a common endpoint in many cardiomyopathies and is associated with adverse outcomes, and precise tools to measure myocardial fibrosis are needed. focal and diffuse myocardial fibrosis can be diagnosed by cardiovascular magnetic resonance (cmr) imaging. however, the cmr procedure is complex and time-consuming and require the use of intravenous gadolinium based contrast agents. a wide range of biomarkers have been associated with the diagnosis and prognosis of cardiovascular disease. in the current study the investigators will assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by cmr. the investigators will also assess whether novel or improved cmr sequences as well as machine learning algorithms improve image quality and the detection of myocardial fibrosis.

this is an observational study of adult patients with suspected myocardial disease referred to cardiovascular magnetic resonance (cmr) with gadolinium contrast. the goal of the study is to assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by cmr. the investigators will also assess novel techniques for detecting myocardial fibrosis by cmr. the plan is to include 1000 patients prior to cmr at akershus university hospital. blood samples for biomarker measurement will be obtained at the time of cmr. image quality of novel cmr sequences will be recorded. the diagnostic results of the cmr will be compared to the levels of selected circulating biomarkers of myocardial injury and fibrosis. novel sequences and techniques for assessing myocardial fibrosis by cmr will be compare to established techniques. patients will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization will be recorded. long-term follow-up information will be obtained from relevant registries

Eligibility criteria:
inclusion criteria: consecutive adult patients referred for clinically indicated cardiovascular magnetic resonance (cmr) imaging with gadolinium contrast at akershus university hospital will be invited to participate. exclusion criteria: participants with contraindication for gadolinium contrast or inability to consent will be excluded

Keywords: cmr myocardial fibrosis biomarkers cardiovascular magnetic resonance imaging
biolux p-iii benelux all-comers registry

Conditions: Peripheral Arterial Disease

Summary: the purpose of the biolux p-iii benelux registry is to further investigate the safety and clinical performance of the passeo-18 lux drug coated ballon when used in daily clinical practice for the treatment of isolated atherosclerotic lesion (vessel narrowing) in popliteal arteries


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or minimum age as required by local regulations * subject must be willing to sign a patient data release form (pdrf) or patient informed consent (pic) where applicable * lesion(s) in the popliteal arteries suitable for endovascular treatment, treated with or scheduled to be treated with the passeo-18 lux drug coated balloon. * isolated popliteal artery lesion: at least 2 cm of healthy segment between lesion(s) in the popliteal artery and lesion(s) in distal superficial femoral artery * inflow free from flow-limiting lesion. patients with flow-limiting inflow lesions (\> 50% stenosis) can be included if lesion(s) have been treated successfully before or during the index procedure, with a maximum residual stenosis of 30% per visual assessment * at least one native artery with direct outflow artery to the foot * rutherford classification 2-5 * patient with bypass surgery in the same limb can be enrolled if there is at least 2 cm healthy segment between popliteal artery and anastomosis exclusion criteria: * life expectancy ≤ 1 year * rutherford classification 6 * lesion involving the superficial femoral artery (arterial intersection with the femur in an anteroposterior view) or extending in infra-popliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk) * aneurysm at the level of the popliteal artery * failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations) * intraprocedural decision not to proceed with the passeo18 lux dcb for any reason not related to the device (for instance blood flow limiting dissection after predilatation) * subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet * subject is pregnant or planning to become pregnant during the course of the study
emotional support messages following a cancer diagnosis

Conditions: Psychological Stress; Anxiety

Summary: cancer patients will be randomly shown one of 18 emotional support messages created by the research team that differ based on how much of the message consists of positive statements and how much consists of negative statements. the messages with negative statements also differ based on whether the negative statements occur at the start or end of the message. after viewing the message, participants have the opportunity to rate the effectiveness of the message, to what extent the message made them feel better, and to what extent the message affects how they view the message provider as a useful source of emotional support.


Eligibility criteria:
inclusion criteria: * participants must be 18 years of age or older * participants with a diagnosis of breast, prostate, thoracic or digestive cancer in the past 3 years * participants consented to moffitt's total cancer care (tcc) protocol and indicating a willingness to be contacted for future research by including an email contact. * ability to read and write fluently in english

Keywords: emotional support cancer
wave~ripples for change: obesity prevention in active youth

Conditions: Childhood Obesity Prevention

Summary: intervention targets youth ages 14 - 19 participating in soccer teams. the intervention group will be given face to face nutrition lessons and have access to an online immersive learning environment. the comparison group will not. the project will test if the immersive learning environment is effective in preventing unhealthy weight gain.

active youth are just as likely to develop poor dietary habits that can contribute to obesity later in life, after high school sports has ended. however, youth in sports may provide a key "window of opportunity" to teach them about eating health foods if that information is tied to sport performance. this project will test to see if that is true. the virtual world is an idea medium for learning for this project. the project will test whether it indeed can result in behavior change more effectively than just more traditional face to face learning.

Eligibility criteria:
inclusion criteria: * youth ages 14 - 19 at baseline * enrolled in a high school soccer program * living with a parent/caregiver in oregon * without medical condition that hinders them from consuming normal healthy diets * has assess to the internet during the 2-year study * proficient in english exclusion criteria: * non-english speakers (youth) * prisoners

Keywords: adolescent sports nutrition physical activity body mass index virtual world
probiotic bio-25 as a supplement to statins for the treatment of hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease ldl-cholesterol levels. the secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin


Eligibility criteria:
inclusion criteria: 1) patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of ldl-cholesterol according to the european socety cardiology guidelines 2012. exclusion criteria: 1. patients on chronic antibiotic treatment 2. patients with immune disorders 3. patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia. 4. patients who experienced myocardial infarction within less than two months. 5. patients who consume probiotics.

Keywords: hypercholesterolemia
efficacy and safety of shr-1314 in patients with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous shr-1314 in patients with active ankylosing spondylitis


Eligibility criteria:
inclusion criteria: - active ankylosing spondylitis, prior radiographic evidence according to the modified ny criteria (1984), inadequate response, contraindications or intolerance to nsaids exclusion criteria: - pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding tnf antagonists
laminoplasty for multilevel cervical spondylotic myelopathy guided by modified k-line and modified sc-line in mri

Conditions: Modified K-line and Modified SC-line in MRI

Summary: this study intended to investigate the combined impact of mk-line and msc-line on the selection of the surgical approach and whether could be used to predict sufficient decompression of cervical spinal cord and clinical outcome in patients after lamp.

this study intended to collect mri of patients with multilevel cervical spondylotic myelopathy. k-line(-) patients can be performed lamp surgery for better prognosis if mk-line(+) and typeⅰsc-line in mri, but there are doubts on typeⅱ and typeⅲ. however, there has been no study that investigated the combination role of the mk-line and sc-line in surgical decision making for patients with mcsm. in this study, the investigators defined mk-line as a straight line connecting the midpoints of the anteroposterior canal diameter at cranial and caudal vertebrae of the open-door segment in mri. accordingly, the investigators propose a modified spinal cord line(msc-line) that is a straight line connecting the postero-inferior point of the spinal cord at cranial and caudal vertebrae of the open-door segment in mri, and simplify the msc-line types into msc-line(+) and msc-line(-). in other words, mk-line and msc-line in mri are not fixed, but vary depending on the preoperative open-door segments. this study included patients with lamp surgery for follow up, whose mk-line and msc-line in mri were double-positive for preoperative deciding open-door segments.

Eligibility criteria:
inclusion criteria: (1) diagnosis of mcsm confirmed by two spine surgeons with mri examination and clinic signs; (2) more than 2 level lesions and/or spinal stenosis in mri, underwent lamp surgery; (3) available for both preoperative and follow-up imaging data and clinical data, including sex, age, clinical symptoms, japanese orthopedic association (joa) score, visual analog scale (vas) score, neck disability index(ndi) score and mri data. exclusion criteria: (1) previous cervical spine surgery; (2) diagnosis of tumor, central cord syndrome, infection or other acute traumatic injuries; (3) diagnosed neurological disorders parkinson's disease, polio, multiple sclerosis, or other central and peripheral nervous system diseases).

Keywords: mk-line msc-line multilevel cervical spondylotic myelopathy
bioavailability study of ondansetron 16 mg orally disintegrating tablets under fasting conditions

Conditions: Healthy

Summary: single-dose cross over comparative bioavailability of ondansetron 16 mg odt and zofran 16 mg odt

to compare the single-dose bioavailability of kali's ondansetron 16 mg odt with that of glaxosmithkine's zofran 16 mg odt under fasting conditions

Eligibility criteria:
inclusion criteria: * availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form(icf) duly signed by the volunteer * males and females aged between 18 and 55 years with a body mass index (bmi) greater or equal to 19 and below 30 kg/ m2 * clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance(laboratory tests are presented in section 6.1.1.3) * healthy according to the laboratory results and physical examination. * non- or ex- smokers exclusion criteria: * significant history of hypersensitivity to ondansetron or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs. * presence or history of significant gastrointestinal, liver or kidney disease, or any conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects. * presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease. * females who are pregnant, lactating or are likely to become pregnant during the study phases. * females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the body. * positive serum pregnancy test before and during the study. * maintenance therapy with any drug, or significant history or drug dependancy, alcohol abuse (\>3 units of alcohol per day, intake of excessive alcohol, acute or chronic). * any clinically significant illness in the previous 28 days before day 1 of this study. * use of enzyme-modifying drugs in the previous 28 days before 1 day of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.). * participation in another clinical trial in the previous 28 days before day 1 of this study. * donation of 500 ml of blood (canadian blood services, hema-quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study. * positive urine screening of drugs of abuse (drug names are presented in section 6.1.1.4). * positive results to hiv, hbsag or anti-hcv tests.

Keywords: bioequivalence ondansetron odt fasting to determine bioequivalence under fasting conditions
canadian observation trial in cf patients undergoing treatment with ivacaftor

Conditions: Cystic Fibrosis

Summary: specific aims: 1. to elucidate the biological mechanism that leads to pulmonary and nutritional improvement in cf patients following treatment with ivacaftor using advanced techniques to assess changes of the pulmonary and nutritional status 2. to examine the relation between the individual response to ivacaftor and the presence of modifier genes associated with cf disease severity, 3. to assess altered cftr function using new available in vivo tests, 4. to validate newly developed in vivo sweat tests with well established functional tests, 5. to establish correlation between the cftr response to vx-770 measured in a new ex vivo method (organoids) and the actual clinical and/or functional response in individual patients, 6. to examine response in other cf-specific features such as aqua wrinkling. 7. to examine if sleep/activity level changes. 8. to establish a biorepository to enable further investigations.


Eligibility criteria:
inclusion criteria: * any patient being prescribed ivacaftor exclusion criteria: * only relates to specific tests