Kornimate/medical-research-clean huggingface dataset:
accuracy of blood glucose detection by diabetes alert dogs

Conditions: Type I Diabetes Mellitus

Summary: even though there is growing interest in and use of trained diabetes alert dogs (dads) as a way to monitor blood glucose in type 1 diabetes (t1d), no scientific studies have confirmed the ability of dads to accurately detect extreme high and low blood sugar. the current project is the first preliminary investigation into the accuracy of dads, using scientifically rigorous research methods similar to those required to demonstrate accuracy in blood glucose meters. the primary aim of the project is to test the hypotheses that dads are accurate at detecting extreme blood sugar levels in adults and children with t1d. the proposed project has several other secondary aims, which include determining: 1) the glycemic thresholds and time course for hypo- and hyperglycemic dad alerts, 2) the degree to which alert accuracy is consistent across different dads, and 3) whether or not dad owners appear to experience better psychosocial status and quality of life compared to other individuals with t1d.

in the proposed project, dad alerts will be compared to blood glucose (bg) readings from a continuous glucose monitoring (cgm) device, as well as a bg meter. cgm, bg meter, and dad alert data will be collected over a 4-wk period. cgm devices will be "blinded" so that bg readings will not be shown. this will allow for a direct comparison between objective glucose readings generated by approved bg monitoring devices and dad alerts. this study will also utilize two methods for measuring dad alerts: (1) use of the event recorder mechanism of the cgm device, and (2) collection of more detailed and qualitative data on dad alerts using diaries (daily dad diaries) to collect information concerning the occurrence, timing, and type of dad alerts.

Eligibility criteria:
inclusion criteria: * the participant must have had type 1 diabetes for at least 1 year and been taking insulin since diagnosis * the participant must have a dad placed in their home for a minimum of 6 months. * participants must not currently be using a continuous glucose monitor (cgm) in their diabetes management. * participants must be capable of performing all tasks involved in the study protocol, including filling out questionnaires and diaries in english. * participants must have an internet-connected computer compatible with study software. * willingness to avoid consumption of acetaminophen-containing products for the duration of the study. exclusion criteria: * pregnant women-self reported * current use of a cgm * history of a systemic deep tissue infection with methicillin-resistant staph aureus or candida albicans

Keywords: diabetes alert dogs hypoglycemia
sensory-evoked cortical gamma oscillation

Conditions: Alzheimer Disease

Summary: the purpose of the study is to investigate the efficacy of cortical gamma oscillation on visual sensory processing and cognitive function in alzheimer's disease (ad) patients by combining a therapeutic sensory stimulation device capable of evoking 40-hz gamma oscillation via non-invasive visual and auditory stimulation with pre-established markers of cortical network activity, i.e., electroencephalography (eeg) and event-related potentials (erp), to evaluate the applicability of the 40-hz multimodel sensory stimulation as a novel therapeutic approach for treatment of ad patients.

the central hypothesis of the study is that sustained 40hz gamma oscillatory sensory stimulation therapy will improve cognitive function in patients with ad. the further hypothesis is that the improvement in cognitive function will result from improved connectivity and cortical network function as measured by eeg and erp. the hypotheses will be tested by the following: 1. - elucidate the immediate impact of gamma oscillations on sensory processing and cognitive function by assessing cognitive function and cortical network function prior to the introduction of sensory stimulation and comparing it to post-therapeutic assessments immediately following the acute administration of therapy on visual processing. 2. - explore the short and long-term therapeutic benefits of a sub-chronic (8 weeks) treatment by assessing cognitive function and cortical network connectivity immediately after the 8 week sensory stimulation therapy. if significant changes are observed between pre-therapy and post-therapy neurophysiologic data for an individual subject, neurophysiological testing will be repeated 4 weeks following the conclusion of therapy. 3. - investigate the correlation between neurophysiology and cognitive function by assessing cognitive function and neurophysiological measures of cortical network activity at multiple time points to determine if therapeutic changes in one domain reflect changes related to the other domain.

Eligibility criteria:
inclusion criteria: * individuals ages 60 and older with established diagnosis of alzheimer's disease as defined by the current consensus criteria for ad (albert et al, 2011, jack et al, 2011; mckhann et al, 2011) * fluent and literate in english language * able to consent for themselves based upon the macarthur competence assessment tool for clinical research * patients with a pre-existing positive a(beta)-pet and/or csf tau/a(beta) markers or willingness to undergo a lumbar puncture (lp) with these results exclusion criteria: * not fluent and literate in english * severe dementia * other medical conditions/neurodegenerative disease that could significantly impair cognitive abilities * cardiac pacemakers or any other implants that may not be compatible with mri * cognitively impaired to the point the patient is unable to consent for themselves * claustrophobic to the point that medication is required
evaluating the efficacy and safety of vardenafil in subjects with erectile dysfunction and hypertension

Conditions: Erectile Dysfunction

Summary: assess efficacy of vardenafil in patients erectile dysfunction and high blood pressure


Eligibility criteria:
inclusion criteria: * men \>/= 18 years of age, with 6 months or longer diagnosis of ed as defined by nih consensus statement, * arterial hypertension adequately controlled * stable sexual relationship for \> 6 month exclusion criteria: * primary hypoactive sexual desire * history of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month * nitrate therapy

Keywords: erectile dysfunction arterial hypertension vardenafil
strongest families (formerly family help program): pediatric attention deficit/hyperactivity disorder

Conditions: Attention Deficit/Hyperactivity Disorder

Summary: the purpose of the strongest families (formerly family help program)is to evaluate the effectiveness of the strongest families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate attention deficit/hyperactivity disorder. this is a single-centre trial based at the iwk health centre. the primary outcome is change in diagnosis.

the purpose of the strongest families (formerly family help program): is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. approximately 60 children (8-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric attention deficit/hyperactivity disorder will be randomized. the intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. the telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team. fifty percent of the eligible participants will receive strongest families (formerly family help program): telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. those receiving standard care will be evaluated for outcome results and then compared to the strongest families treated participants. it is anticipated that strongest families treatment will be proven to be as or more effective than standard care.

Eligibility criteria:
inclusion criteria: * child 3 to 7 years of age * child had behavioural problems for 6 months or longer * access to a telephone in the home * speak and write english * mild to moderate attention deficit/hyperactivity symptomology exclusion criteria: * severe attention deficit/hyperactivity symptomology * received similar intervention within past 6 months * autism or schizophrenia * child has intellectual impairment
korean nationwide multicenter pooled registry of drug-eluting stents

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (des) and to determine clinical device and procedural success during commercial use of des in the real world. the investigators will compare ees (xience v/promus and xience prime), ses (cypher), zes (resolute integrity, endeavor resolute, endeavor), and bes (biomatrix, biomatrix flex, and nobori).

the grand drug-eluting stent (grand-des) registry incorporated five different multicenter registries in south korea. the excellent prospective cohort and the excellent-prime registry were dedicated for durable polymer-coated everolimus-eluting stents (dp-ees; xience v/promus and xience prime) or 1st-generation sirolimus-eluting stents (cypher), the host-resolinte and resolute-korea registry for durable polymer-coated zotarolimus-eluting stents (dp-zes; resolute integrity and endeavor resolute) or 1st-generation endeavor-zes, and the host-biolimus-3000-korea registry for biodegradable polymer-coated biolimus-eluting stents (bp-bes; biomatrix, biomatrix flex, and nobori). during the period of 2008 through 2014, all registries enrolled all-comers without any exclusion criteria except patient's withdrawal of consent.

Eligibility criteria:
inclusion criteria: * the patient agrees to participate in this study by signing the informed consent form. * alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. exclusion criteria: * there are no exclusion criteria for this registry.

Keywords: everolimus sirolimus zotarolimus biolimus drug-eluting stent
efficacy and safety of birch pollen immunotherapy in local allergic rhinitis

Conditions: Allergic Rhinitis; Allergic Reaction

Summary: local allergic rhinitis (lar) is relatively new disease. the question of effect of allergen specific immunotherapy on lar is open. the randomized, double blind placebo controlled trial of birch subcutaneous ait on lar were performed in twenty eight patients. the therapy was performed during 24 months in proportion 15 patients with ait and 13 placebo. the primary endpoint was decreased of symptoms medication score (sms). additionally monitoring serum specific ige, specific igg4 and nasal specific ige (nsige) to bet v1 and parameters of safety and quality of life were provided.

local allergic rhinitis (lar) is still an under diagnosed and under treated disease. it is characterised by local production of ige during natural exposure to aeroallergens. these patients have negative skin prick tests and serum-specific iges but have positive nasal provocation tests for aeroallergens. more than 50% of patients with chronic non-allergic rhinitis may have a problem with lack of lar diagnosis. misdiagnosis can lead to mistakes in the treatment as well as inefficiencies. besides on only local ige-mediated reaction, allergen immunotherapy (ait) could be a potential way of treatment such patients. however, there are only sufficient data that the ait is effective in allergic rhinoconjunctivitis and asthma to pollens and house dust mites and some animal. the aim of this study was to assess the safety and efficacy of ait for birch pollen allergens in patients with local allergic rhinitis and a confirmed birch pollen allergy.

Eligibility criteria:
inclusion criteria: * well document symptoms of rhinitis during birch pollen season * positive nasal provocation test to birch * negative results of skin prick tests to inhalant allergen including: d. pteronyssius, d. farinae, grass pollen, birch, hazel, alder alternaria, and cat. * negative results of serum total and allergen specific ige against mentioned allergens. exclusion criteria: * diagnosis of bronchial asthma, non-allergic rhinitis (especially senile or vasomotor rhinitis) and severe non-stable diseases. all subjects were required to abstain from anti-allergy drugs and glucocorticoid nasal drops for at least 6 weeks prior to the start of the study.
the impact of phosphate metabolism on healthy aging

Conditions: Hypophosphatemia; Rickets; Hypercalciuria; XLH; HHRH

Summary: determine the association between duration and dose of chronic conventional therapy with pi and renal (nephrocalcinosis/nephrolithiasis), vascular (endothelial function), and cardiovascular function (echo- cardiography) in patients with hereditary hypophosphatemic rickets with hypercalciuria (hhrh) and patients with x-linked hypophosphatemia (xlh).

the central hypothesis of this proposal is that patients with x-linked hypophosphatemia (xlh), when matched for duration and dose of phosphate (pi) therapy to patients with hereditary hypophosphatemic rickets with hypercalciuria (hhrh), will evidence greater cardiovascular and vascular debility than patients with hhrh. the overall objectives of this project are to utilize our existing longitudinal databases for individuals with xlh and hhrh through an interdisciplinary collaboration between pediatric and adult endocrinology to: i) quantify the impact of exposure to pi therapy across the lifespan on cardiovascular and renal complications, which are key aging endpoints, ii) determine the acute response to pi loading in xlh and hhrh by studying the changes in surrogate markers of cardiovascular and renal function.

Eligibility criteria:
inclusion criteria: * children above the age of 13 years * younger and older adults with xlh and hhrh with confirmed npt2c mutations affecting both copies of the npt2c gene (hhrh) or one copy of the phex gene (xlh) * be willing to provide access to prior medical records to determine eligibility including imaging, biochemical, medical, and surgical history data * be willing and able to complete all aspects of the study * be willing to adhere to the study visit schedule and comply with the assessments (in the opinion of the investigator). exclusion criteria: * subjects will be excluded, if they are children younger than age 13 years * subjects that have other diseases likely to impact bone and mineral metabolism (e.g. renal, hepatic, gastrointestinal disorders, and malignancy), * subjects that are currently pregnant, * subjects that received medical therapy or developed any condition, which in the opinion of the investigator, could present a concern for either subject safety or difficulty with data interpretation. * subjects will be excluded from aim 2, if they are unable to tolerate supplemental phosphate.
sintilimab combined with lenvatinib in local advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this ia a single-arm, single-center, not-randomized, open-label phase ii study. the purpose of this study is to evaluate the efficacy and safety of sintilimab (pd-1 antibody) combined with lenvatinib(tki) for the treatment of local advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology * barcelona clinic liver cancer (bclc) stage c disease without any distant or lymphatic metastasis , or bclc stage b disease not amenable to curative surgery * no previous systemic anticancer treatment or tace treatment * age ≥18 years * ecog performance status: 0-1 * child pugh score≤7 * has at least one measurable hepatocellular carcinoma (hcc) lesion based on recist 1.1 * life expectancy ≥12 weeks. * patients must be able to understand and willing to sign a written informed consent document exclusion criteria: * fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma * history of hepatic encephalopathy or liver transplantation * pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. * untreated hepatitis infection: hbv dna\>2000iu/mlor10000 copy/ml, hcv rna\> 1000copy/ml, both hbsag and anti-hcv body are positive. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * history of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity * with serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable. * evidence of active pulmonary tuberculosis (tb). * positive test of immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids) * history of allergic reactions to related drugs * pregnant women, nursing mothers
safety and tolerability study of drug to treat schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the long-term safety of sm-13496 in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * successful completion of participation in protocol #d1050049 exclusion criteria: * substance abuse * prolactin level of ≥200ng/ml at baseline * pregnancy

Keywords: schizophrenia latuda lurasidone
vagus nerve stimulation for post-covid syndrome

Conditions: Long COVID; Vagus Nerve Stimulations; Heart Rates; Autonomic Nervous System Disorders

Summary: the aim of this study is to increase parasympathetic activity and decrease the severity of symptoms by providing vagal stimulation with the t-vns method in order to suppress the increased sympathetic activity in patients with prolonged covid symptoms.the main question\[s\] it aims to answer are: question 1:is left ear transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in post covid syndrome? question 2:is bilateral auricular transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in post covid syndrome? a 5-minute heart rate variability measurement will be performed to measure the effectiveness of vagus nerve stimulation in participants.hrv is a non-invasive method used to evaluate ans activity and is a measure of heart rate change over a period of time


Eligibility criteria:
inclusion criteria: * being 18 years or older * experiencing at least one of the post-covid symptoms for 12 weeks or longer exclusion criteria: * considering that the female reproductive hormones level in the body and menstrual cycle may affect the ans in female patients, female participants in perimenopausal, post-menopausal and pregnancy conditions were excluded from the study. * participants who used medication for the treatment of ans dysfunction in the last six months were also excluded from the study.
pharmacokinetics study of ckd-11101 and nesp after iv administration in health male volunteers

Conditions: Anemia

Summary: the purpose of this study is to investigate the pharmacokinetics of ckd-11101 and nesp after iv administration in health male volunteers

healthy volunteers are administrated ckd-11101 60μg and nesp 60μg once intravenously. (crossover) every time before and after taking each medication, pk parameters and safety of ckd-11101 60μg and nesp 60μg are performed using a blood sample and conducting some tests(laboratory test, v/s and physical examination, etc) respectively.

Eligibility criteria:
inclusion criteria: * signed the informed consent form prior to study participation. * a healthy male volunteer between 20 and 55 years old. * body weight between 55kg and 90kg, bmi between 18 and 27. * appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.) exclusion criteria: * have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases * clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor * have abnormal laboratory result. * hemoglobin \ 17g/dl * vitamin b12 \< 200pg/ml * ferritin \< 21.8ng/ml * transferrin \< 190mg/dl * reticulocyte over the normal limit * positive for the triage tox drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids) * positive for hiv antibody, hbsag, hcv antibody test * a heavy smoker (cigarette \> 10 cigarettes per day) * administer epo, darbepoetin, immunoglobulin or iv iron within 3 months prior to the first ip administration * have hypersensitivity reactions history for epo, darbepoetin, excipient of ip or iron tablets * sit sbp \ 140mmhg or sit dbp \ 90mmhg or pulse rate \> 100 per/min * history of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening * subject takes ethical drug or herbal medicine within 14 days, otc or vitamin supplements within 7 days before the first ip administration * participated in the other clinical trials and administrated ip within 8 weeks prior to the first ip administration * a heavy alcohol consumer (alcohol \> 21 units/week) or cannot stop drinking * bleed or donate blood (\> 400ml) within 8 weeks before the first ip administration * participated in this clinical trials and administrated ip * have a diet within 2 days before the first ip administration or cannot stop having * food containing grapefruit * food containing caffeine * disagree to avoid getting pregnant during clinical trial * an impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason

Keywords: ckd-11101 nesp darbepoetin alfa anemia intravenous pharmacokinetics phase 1