Kornimate/medical-research-clean huggingface dataset:
hot flash as a marker of cardiovascular risk in recent postmenopause: effects of non-hormonal treatments

Conditions: Postmenopausal Flushing; Cardiovascular Risk Factor; Endothelial Dysfunction

Summary: hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with cardiovascular disease and endothelial dysfunction. estrogen therapy, associated or not with progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial function of postmenopausal women with hot flushes, even those with cardiovascular risk factors, such as hypertension. it is not known whether hot flushes are a cause for the development of endothelial dysfunction or are markers of this dysfunction, evidenced by estrogen deficiency, thus representing primitive target organ (vessel) lesion. paroxetine was approved by the fda as a non hormonal treatment for menopausal hot flashes. in this double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5 mg / day, compared to placebo, during 12 weeks are evaluated.

paroxetine and placebo effects at baseline and after 12 weeks in endothelial, autonomic and pressure components of vascular function are evaluated. non invasive venous occlusion plethysmography is used to study endothelial function; ambulatory blood pressure monitoring is used to study blood pressure variations during daytime and nocturnal descent; autonomic function is studied following sympathetic and parasympathetic parameters through heart rate variability. the effects of paroxetine and placebo are also evaluated on: * daytime sleepiness (through epworth sleepiness scale ), * sleep quality (through pittsburgh sleep quality index), * perceived stress (through perceived scale stress). biochemical and hormonal profiles including complete lipid profile, fasting glucose, insulin, estradiol, follicle stimulating hormone (fsh), luteinizing hormone (lh); inflammatory and oxidative stress markers are also studied.

Eligibility criteria:
inclusion criteria: 1. postmenopause 2. present hot flushes (note ≥ 3 on a scale of 0 to 10) exclusion criteria: 1. \> 10 years of hypoestrogenism 2. smoking 3. diabetes mellitus or altered fasting glycemia in use of oral hypoglycemic agents or insulin 4. bmi ≥ 35 kg / m2 5. uncontrolled hypertension - blood pressure (bp) ≥ 140/90 mmhg 6. users of glucocorticoids, phytoestrogens, β-blockers, selective serotonin reuptake inhibitors (ssris), selective noradrenaline reuptake inhibitors (snris), clonidine, gabapentin, pregabalin, cinnarizine, alphamethyldopa or any drugs with effects on the central nervous system; 7. uncompensated hypo or hyperthyroidism; 8. previous cardiovascular event history.

Keywords: postmenopause paroxetine endothelial dysfunction blood pressure heart rate variability sleep quality perceived stress sleepiness
defining an obesity qtl on chromosome 3q

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to investigate the genetic basis of obesity by fine mapping an obesity quantitative trail linkage (qtl) linked to chromosome 3q.

background: in the last several decades obesity has emerged as a major public health threat. while prevention through lifestyle change is the only long-term solution, better understanding of the physiologic mechanisms would greatly assist development of drugs and targeted prevention. obesity is a highly heritable condition and while genes must account for a substantial proportion of individual susceptibility they have eluded detection. powerful new genetic and genomic tools now permit comprehensive evaluation of candidate genes, including all genes under linkage peaks. these tools include new genomic resources (the human genome sequence, databases of common snps, and the haplotype map), rapid and inexpensive discovery and genotyping and new analytic methods (haplotype-based association and admixture mapping). design narrative: in a large african american family set dr. zhu and colleagues have obtained strong linkage evidence for obesity on chromosome 3q (combined lod score = 3.7). a prime candidate (adiponectin) lies near this peak. they propose to follow up that finding by combining the epidemiologic data with high-throughput genotyping and move from linkage to association analysis. the results for this qtl will be evaluated within the available environmental factors to assess potential gene-environment and gene-gene interactions. the available phenotypes include body composition, resting metabolic rate, physical activity, plasma insulin, glucose, and leptin. in a family-based design they will examine the linkage peak centered on position 188 cm on chromosome 3q (20 cm 1-lod support interval), with the following step-wise strategy: (a) genotype 200 single nucleotide polymorphisms (snps) in this region on 300 families (1,000 individuals); (b) conduct linkage, linkage disequilibrium and admixture mapping to potentially further narrow the region; and (c) conduct resequencing and haplotype-based association studies for all candidate genes under the peak. statistical analysis incorporating intermediate phenotypes and environmental covariates will be used to characterize potential gene x gene or gene x environment interactions. replication will be tested in additional populations of african and european origin.

Eligibility criteria:
the survey enrolled a representative random sample of the population the age of 18 and 74, regardless of obesity phenotype.
establishment and effectiveness evaluation of a training system for confocal laser endomicroscopy

Conditions: Gastric Cancer; Gastric High-grade Intraepithelial Neoplasia; Gastric Low-grade Intraepithelial Neoplasia; Gastritis

Summary: gastrointestinal endoscopy is a vital method for screening and diagnosing gastric cancer. it aids in identifying the tumor's location within the stomach and its macroscopic type, and allows biopsy for histological confirmation. moreover, suspicious lesions can be further examined using specialized endoscopic techniques such as magnifying endoscopy (me) combined with electronic staining, chromoendoscopy, confocal laser endomicroscopy (cle) and fluorescence endoscopy. me combined with electronic staining has been confirmed to achieve excellent diagnostic accuracy in distinguishing between noncancerous and cancerous lesions. however, me is technically challenging, and gastric magnifying endoscopy involves various evaluation criteria such as the vessel plus surface classification system and kudo's pit pattern classification, leading to a steep learning curve. confocal laser endomicroscopy (cle) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. despite having been available for approximately 20 years, and its accuracy in diagnosing gastric neoplastic lesions having been confirmed by several studies, the clinical application of cle is not widespread, and there is a lack of relevant standards to guide the training of cle endoscopists. to train more cle endoscopists, we organized cle training courses. we also evaluated the training's effectiveness and try to explore the influencing factors of learning curve.


Eligibility criteria:
inclusion criteria: * atients aged 18 to 85 years who were scheduled for detailed endoscopic examination at the first affiliated hospital of naval medical university were consecutively enrolled. exclusion criteria: * nwillingness to undergo cle examination * hypersensitivity to sodium fluorescein * hepatic or renal insufficiency

Keywords: confocal laser endomicroscopy gastric neoplastic lesions
allogeneic stem cell transplantation in chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: patients with advanced chronic lymphocytic leukemia (cll) have a poor long-term prognosis. allogeneic stem cell transplantation (sct) in patients with cll has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related mortality. however long-term disease-free survival after allogeneic sct has been reported. recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens. yet, graft versus host disease (gvhd) remains an important problem in this setting. alemtuzumab is an effective drug for the treatment of patients with advanced cll and has been successfully applied for gvhd-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens. the goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic sct in patients with advanced cll.

patients with relapsed or refractory cll who are eligible for the study receive a cytoreductive therapy until sct. irrespective to the formal response, patients proceed to allogeneic sct after fludarabine-based reduced-intensity conditioning. the use of granulocyte colony-stimulating factor (g-csf)-mobilized peripheral blood stem cells \> 3 x 10e6 cd34 cells/kg is recommended, but bone marrow \> 1 x 10e8 mnc/kg is accepted. gvhd-prophylaxis is based on cyclosporine a adapted to blood levels (150 to 200 ng/ml) over a period of three months. in phase i of the study, alemtuzumab has been applied as part of the conditioning regimen until day 5. in phase ii, alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14 and after amendment ii in september 2006 scheduled for day 28. furthermore methotrexate is given on days 1, 3, 6. and 11 at a projected cumulative dose of 45 mg/m2. subsequent immunosuppressive therapy depends on the occurrence of gvhd, the development of chimerism, and residual disease. patients with relapsing or residual disease (minimal residual disease excluded) who do not suffer from gvhd should receive donor lymphocytes in increasing dosages. the initial dose is 1 x 105/kg t-cells in unrelated donors and 1 x 106/kg in matched related donors. if no gvhd develops within 6-8 weeks, the next higher dosage is applied.

Eligibility criteria:
inclusion criteria: * written informed consent * sufficient organ function * availability of an hla-compatible donor (related or unrelated) * age \< 65 years * karnofsky index \> = 70% * b-cll requiring treatment after failure of at least one prior cytostatic treatment exclusion criteria: * positive hiv-serology * pregnancy * intolerance to study drugs * second neoplasia * serious infections

Keywords: chronic lymphocytic leukemia reduced intensity conditioning alemtuzumab allogeneic stem cell transplantation
prospective observational study of filgotinib in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: an observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (ra) receiving filgotinib in real-world setting.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years with a diagnosis of moderate to severe active ra being prescribed filgotinib in accordance with the local standard of care and product label for the first time. * patients must be willing and able to use an electronic device to complete the study patient-reported outcome (pro). exclusion criteria: - participation in any other interventional or non-interventional study without prior approval from the medical monitor. this does not preclude inclusion of patients enrolled to national registries.

Keywords: filgotinib safety effectiveness patient reported outcome
postprandial glucose, insulin responses and appetite hormones to dried mushrooms

Conditions: Metabolic Syndrome

Summary: obesity, characterized by an increase in body weight that results in excessive fat accumulation, is a global health problem. recently, it has also been shown that obesity is associated with low-grade chronic systemic inflammation in adipose tissue. this condition is mediated by activation of the innate immune system in adipose tissue that promotes inflammation and oxidative stress and triggers a systemic acute-phase response. previous research points towards the potential of phytochemicals in food as part of nutritional strategies for the prevention of obesity and associated inflammation, as well as, increase in insulin sensitivity in diabetic patients. the last decade, mushrooms have attracted the research interest as functional foods rich in beta-glucan with desirable health benefits in several metabolic disorders without the side effects of pharmacological treatment. edible mushrooms are highly nutritious and exhibit beneficial effects on several inflammatory diseases such as cancer, heart disease, diabetes,, high blood pressure. however, the postprandial effect of mushrooms in human biological samples is still undetermined. to this end, the current study aims to investigate if there is any effect at postprandial glucose, insulin responses and appetite hormones. fifteen apparently men and women with metabolic syndrome, aged 18-65 years old, will be enrolled based on certain inclusion and exclusion criteria. after enrollment, the volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count. on the day of the experiment and after overnight fasting, the volunteers will consume one of two breakfast meal, including 114g bread, 40g cheese and 15g dry mushrooms (meal 1) or 114g bread, 40g cheese and 200g tomatoes (meal 2). blood samples will be obtained on timepoints 0h, 30min, 1h, 1,5h, 2h, 2,5h and 3h after breakfast intake. two weeks later, the same volunteers will consume the other breakfast meal. after collection, the glucose and insulin values will be identified in plasma samples. additionally, some appetite hormones will be measured in serum samples.


Eligibility criteria:
inclusion criteria: 18 years \ 25 kg/ m2 metabolic syndrome exclusion criteria: hepatotoxic medication diabetes mellitus dysthyroidism, hypopituitarism, cushing syndrome / disease pregnancy, lactation psychiatric or mental disorder any use of antioxidant-phytochemical rich supplement, vitamin d supplement, nti-, pre- or pro-biotics within 3 months pre-intervention
effect of timing of tumor-treating fields plus short-course radiation

Conditions: Newly Diagnosed Glioblastoma in Patients ≥70 Years

Summary: the purpose of the study is to assess timing of ttfields use as well as safety, feasibility and preliminary efficacy of treatment with ttfields in elderly patients with newly diagnosed gbm simultaneous to rt/ crt. the primary aim of the trial is to establish a safely conducted therapy rate higher than 0.8 in the treatment arm.

despite the immense effort made over the years with different treatment modalities, the survival of patients with newly diagnosed gbm is still very poor; no treatment is curative; and the quality of life of patients with this tumor is compromised significantly, not only by their disease but also by side effects of these rigorous treatment plans. especially in elderly patients, a treatment modality is needed that will improve the results of current standard treatments without further impairing the quality of life of these patients for their limited life span. the objective is to test the feasibility and timing of treatment with the ttfields device in elderly patients with newly diagnosed gbm simultaneous or subsequent to rt/ crt. the primary rationale to conduct this study is to improve treatment in the segment of high-grade brain tumors with the highest medical need. all procedures regarding ttfields are representing routine clinical care within the approved use of the medical product in germany; the present trial aims to investigate the optimal timing of ttfields use in elderly gbm patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed, newly diagnosed glioblastoma (astrocytoma who grade iv) * indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide * open biopsy or resection * craniotomy or intracranial biopsy site must be adequately healed * informed consent * age: \>65 years * kps ≥50% * ability of subject to understand character and individual consequences of the clinical trial * written informed consent of participation exclusion criteria: * concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen. * any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry * prior rt of the brain * patients who have not yet recovered from acute high-grade toxicities of prior therapies * mri or ttfields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts) * known hypersensitivity to conductive hydrogels * pregnant and lactating women
prospective regional epilepsy database

Conditions: Epilepsy

Summary: predict is an observational study following adults with an unprovoked seizure or epilepsy in the health care region of western sweden. the objective is to identify biomarkers and/or genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the long-term prognosis and consequences of epilepsy.

adults over 18 years of age, with an unprovoked seizure in the last year or epilepsy, resident in the health care region of western sweden (vgr) at the time of inclusion. baseline data and outcome variables are collected from several patient registries: the electronic medical records system in the health care region vgr and swedish national registers of healthcare, income, and employment managed by the national board of health and welfare or statistics sweden, both of which are government agencies.

Eligibility criteria:
inclusion criteria: * over 18 years of age * an unprovoked seizure within the last year or a diagnosis of epilepsy according to the current international league against epilepsy definition (epilepsy with seizure in the last ten or antiepileptic drug treatment in the last five years) exclusion criteria: * expected survival less than two years * inability to give informed consent

Keywords: epilepsy biomarker access to care quality of care seizure
helping problem drinkers on the internet

Conditions: Alcohol Dependence

Summary: the main aim of this study is to compare the impact of a minimal and a full internet-based self-help intervention for problem drinkers in the general population.

many problem drinkers never access any treatment services. because of the individual as well as societal costs of heavy alcohol consumption, it is essential to find ways to intervene and provide assistance to problem drinkers. the internet takes treatment to problem drinkers rather than requiring them to come to treatment, resulting in increased options for help for alcohol abusers. there is a preponderance of internet websites which are designed for self change in areas that include alcohol use. to date, however, there has been minimal scientific evaluation regarding the efficacy and safety of such programs. our own previous research found that we could reduce alcohol consumption by about three drinks per week at a six-month follow-up using a minimal, personalized feedback internet-based intervention. building on this, the current project will attempt to increase the impact of internet-based interventions as well as produce sustained reductions in drinking by adding an extended online self-help service to this already promising minimal intervention. more specifically, this randomized, double blinded study will compare and evaluate the efficacy of two different degrees of treatment intervention for problem drinkers: a minimal one ("check your drinking") and a full one ("alcohol help centre").

Eligibility criteria:
inclusion criteria: * resident of ontario * 19 years of age or over * have consumed alcohol in the one month prior to the telephone survey. * have consumed alcohol in the one month prior to the telephone survey. * a score of 8 or over on the alcohol use disorders identification test (audit) * indicate an interest in receiving self-help materials * have home access to the internet * are willing to participate in follow-up at six and twelve month intervals exclusion criteria: * none

Keywords: problem drinking alcohol dependence alcohol abuse internet based intervention treatment alcohol use disorders identification test
research accelerated by you lupus registry

Conditions: Systemic Lupus Erythematosus (SLE); Lupus Nephritis (LN); Cutaneous Lupus Erythematosus (CLE)

Summary: the lupus foundation of america (lfa) research accelerated by you (ray) registry is an ongoing, voluntary, longitudinal study gathers data from adults with lupus and legally authorized representatives of children with lupus to better understand diagnosis, treatment, care, and quality of life. participants provide informed consent and complete electronic surveys every six months. the lfa uses the data to address constituent needs, share clinical research opportunities, and advance lupus research by sharing de-identified data with approved third-party investigators. the lfa will promote participation via its website and email outreach to around 200,000 people connected to lupus. participants may also be resurveyed to assess clinical trial eligibility and other factors related to trial participation. types of self-reported data will include: demographics, diagnoses, treatment information and patient reported outcomes, including quality of life reports, which have been increasingly recognized as essential for assessing health outcomes.


Eligibility criteria:
inclusion criteria: * for adults with lupus, the individual who completes the registry: * is 18 years of age or older * has a self-reported diagnosis of lupus by a physician or health care provider * is willing and able to provide informed consent * is able to read and understand english sufficiently to complete the survey questions * has access to a computer with an internet connection for children under 18 with lupus, the individual who completes the registry is: * 18 years of age or older * the parent/legal guardian/legally authorized representative of a child under 18 years of age that has a diagnosis of lupus by a physician or health care provider * willing and able to provide consent for the child under 18 years of age and to obtain assent from the child between 7-17 years of age * able to access a computer with an internet connection * able to read and understand english sufficiently to complete the survey questions for adults with lupus unable to provide consent, the individual who completes the registry is: * 18 years of age or older * the legally authorized representative of an adult 18 or older who is unable to provide consent and has a diagnosis of lupus by a physician or health care provider * willing and able to provide consent for the adult with lupus * able to access a computer with an internet connection * able to read and understand english sufficiently to complete the survey questions exclusion criteria: -

Keywords: lupus registry