Kornimate/medical-research-clean huggingface dataset:
interaction of cocoa methylxanthines with cocoa flavanol related vascular effects

Conditions: Cardiovascular Diseases

Summary: epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. endothelial dysfunction is the key event in the development and progression of cardiovascular disease. aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. however, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. the aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.


Eligibility criteria:
inclusion criteria: * healthy male subjects * \>18 years exclusion criteria: * acute inflammation * cardiac arrhythmia * renal failure * heart failure (nyha ii-iv) * diabetes mellitus * crp \> 1 mg/dl * malignant disease

Keywords: flavanols cardiovascular effects nutrition-nutrition interaction
rtms for treatment of pain and craving

Conditions: Pain, Chronic; Pain Acute

Summary: the purpose of this study is to develop repetitive transcranial magnetic stimulation (rtms) as a potential treatment for pain in individuals on prescription opioid medication. repetitive tms is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). this study will test whether 10 days of rtms over the prefrontal cortex can produce a reduction in perception of pain and the desire to use opiates. tms has been approved by the fda as an investigational tool as well a therapy for depression.

individuals between the ages of 18 and 65 with current (past 3 months) prescription opioid use and chronic pain are being recruited. participants will be screened on the telephone for major inclusion/exclusion criteria. individuals meeting inclusion criteria based on the screening assessment will be set up for an appointment in the clinic. participants will be instructed not to use alcohol, prescription opioids, or any other drugs on the day of their appointment. all study procedures will take place at the 30 bee street location of the brain stimulation lab (bsl). the protocol contains 1 screening visit, 10 tms visit, and 2 follow up visits. individuals that are eligible following the screening visit will be randomized to receive real or sham tms. on each tms visit participants will undergo a single 20-minute session of 10hz real or sham rtms (on-time=5 secs, off-time=10 secs) at up to 110% of resting motor threshold using a magventure magpro tms machine. primary outcomes will be: 1. change in pain sensitivity levels in the pain assessment task and 2. change in levels of opiate craving. the investigators will use analysis of variance models with group (real rtms vs. sham) as the between-subjects factor and time (pre- to post-tms) as a within-subject factor. the investigators will test the hypothesis that rtms will result in significantly lower levels of reported pain sensitivity and craving, as compared to sham. blind interim analyses of the data will be conducted when 50% of the sample has been accrued.

Eligibility criteria:
inclusion criteria: * age 18-65 * currently prescribed prescription opiates for pain exclusion criteria: * documented history of seizures * unstable chronic medical illness * currently using any medications known to lower seizure risk * metal above the waist * pregnancy * history of a negative reaction to tms

Keywords: treatment brain stimulation
efficacy of esomeprazole in patients with frequent heartburn

Conditions: Heartburn

Summary: this study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn


Eligibility criteria:
inclusion criteria: * males and non-pregnant ,non-lactating females 18 years or older * experience heartburn at least 2 days a week * having heartburn that has responded to heartburn medication * must discontinue any current heartburn medications exclusion criteria: * having a history of erosive esophagitis verified by endoscopy * having a history of gerd which was diagnosed by a physician * inability to take study medication or complete the study and all study procedures * subjects that have required more than one 14-day course of ppi treatment within the past 4 months

Keywords: heartburn
stroke - sleep disorders, dysfunction of the autonomic nervous system and depression

Conditions: Stroke

Summary: the purpose of this study is to investigate sleep disordered breathing, autonomic dysfunction, and post stroke depression in acute and chronic stroke patients. furthermore, to explore the interaction between these comorbidities, and their relation to stroke aetiology.

up to fifty percent of stroke patients suffer less noticeable comorbidities after the acute phase of a stroke and often the rest of their life. it concerns sleep disordered breathing (sdb), post stroke depression (psd), and dysfunction of the autonomic nervous system. these comorbidities are seldom recognized, but are associated with a poorer outcome after stroke, reduced quality of life as well as an increased risk of new vascular events. little is known about the course of the comorbidities, the relationship between the mentioned diseases or which patients are more commonly affected. the investigators will investigate the following hypotheses, and assess the results compared to the stroke aetiology: 1. stroke patients with sdb have an impaired autonomic function 2. stroke patients with sdb have an increased risk of psd 3. stroke patients with autonomic dysfunction have an increased risk of psd the investigators will examine stroke patients for signs of sleep disordered breathing, autonomic dysfunction and depression, both in the acute phase (days), in the chronic phase (months) and the very chronic state (years). thereby the investigators can map the comorbidities course over time. at the same time the patients will be tested for peripheral small and large artery disease as well as mri will be used to investigate sign of cerebral small vessel disease. based on power calculations 335 individuals will be enrolled in order to satisfy the project requirements.

Eligibility criteria:
inclusion criteria: • clinical stroke either ischaemic or haemorrhagic exclusion criteria: * transitory ischemic attac * congenital or acquired brain disease, other than stroke * dementia * mental retardation * fatal stroke or severe comorbidities with short expected life * pregnancy or breastfeeding * altered consciousness e.g. delirium or status epilepticus * other cause of the patient, according to the investigator believes, can not complete the study

Keywords: sleep apnea syndromes autonomic nervous system +/- disease depression peripheral arterial disease
safety and immunogenicity of two doses of ah5n1 vaccine in adult and elderly subjects with and without underlying medical conditions

Conditions: Influenza, Human

Summary: evaluate the safety, immune response and reactogenicity of ah5n1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without underlying medical conditions.


Eligibility criteria:
inclusion criteria: * - male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry; * individuals who are able to comply with all study procedures and requirements; * healthy volunteers and volunteers specifically with underlying copd, cardiovascular disease, diabetes mellitus, peripheral vascular disease, or renal impairment may be eligible; * please contact the site for additional eligibility criteria. exclusion criteria: * individuals who are not able to follow all the required study procedures for the whole period of the study; * individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study; * please contact the site for additional eligibility criteria.

Keywords: influenza h5n1 ah5n1 h5n1 vaccine pandemic influenza vaccine mf59, adjuvant, avian flu underlying medical conditions underlying cardiovascular medical condition pandemic vaccine charlson comorbidity index (cci) adjuvanted vaccine
labour pain is a subjective experience. the degree of a woman's suffering in childbirth depends on indirect factors

Conditions: Pain, Labor

Summary: pain during childbirth is a complex and subjective experience. the degree of a woman's suffering in childbirth depends on the intensity of labour pain and many indirect factors. complex interrelated effects on labour pain are limited by the little number of studies available. that is why it is necessary to determine the probable factors that may affect the intensity of pain.

a prospective observational study was conducted in the period from december 2020 to may 2021 at the kyiv city maternity hospital №5 (kyiv, ukraine). the study protocol was approved by the bogomolets national medical university ethics committee. the examined predictors were derived from mothers' self-report of overall childbirth. 366 women took part in research, 282 of participants rated their pain by ≤ 60 mm visual analog scale (vas), while 84 patients reported their pain by ≥70 mm vas. the aim of study was to investigate predictors of severe labour pain. in the postpartum period all patients filled questionnaires and underwent interviews from the 1st to the 3rd day after delivery. the following groups of risk factors were studied: 1. demographic indicators (age, level of working capacity 2 months before childbirth, attendance of maternity school). 2. general level of health (woman's level of health before childbirth, daily physical activity before childbirth, bad habits - smoking during pregnancy). 3. presence of mental disorders before childbirth (level of anxiety 2 weeks before childbirth, widespread muscle pain with fatigue or problems with memory, sleep, and mood). 4. the presence of chronic pain, chronic headache or chronic back pain, the presence of rheumatoid arthritis during pregnancy, the presence of increased intracranial pressure during pregnancy. 5. presence of chronic intestinal diseases (irritable bowel syndrome). 6. the level of assistance during childbirth (constant support of the doula during childbirth, the woman's ability to control pain in childbirth).

Eligibility criteria:
inclusion criteria: * mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus. exclusion criteria: * mothers over 45 years of age, inability to obtain the informed consent of the patient or his legal representative.

Keywords: labor pain antenatal education support by doula
a study to evaluate the safety, tolerability, and efficacy of escalating doses of bms-986463 in participants with select advanced malignant tumors.

Conditions: High-grade Serous Ovarian Carcinoma (HGSOC); Uterine Serous Carcinoma (USC); Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of bms-986463 in participants with select advanced malignant tumors.


Eligibility criteria:
inclusion criteria * participants must have an eastern cooperative oncology group performance status of 0 or 1. * participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained. * participants must have an unresectable/metastatic carcinoma. exclusion criteria * participants must not have leptomeningeal metastases. * participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. * participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment. * other protocol-defined inclusion/exclusion criteria apply.
acute exercise and the cerebral metabolic response in aging and alzheimer's disease

Conditions: Healthy Aging; Alzheimer Disease

Summary: the overall goal is to characterize the acute exercise response as it relates to brain glucose metabolism in aging and alzheimer's disease (ad). the study team will also examine lactate metabolism, relationships with cognition, and the effect of exercise intensity.

aim 1: compare the effects of acute, moderate intensity and acute, higher intensity exercise on cerebral glucose metabolism in nondemented (nd) elderly and ad subjects. nd (n=30) and ad (n=30) subjects will undergo a single bout of moderate intensity (45-55% hrr) or higher intensity (65-75% hrr) exercise to assess the effect of exercise intensity on acute change in brain glucose metabolism (rest to exercise). investigators hypothesize that both moderate and high intensity exercise will elicit a drop in global brain glucose metabolism compared to quiet rest, but that the effect will be greater with higher intensity vs. moderate intensity exercise, and greater in nd subjects than in ad subjects. aim 2: characterize the effect of both exercise intensities on acute biomarker response and cognition (memory and executive function) in nd and ad subjects. the acute biomarker response to exercise and the effect on cognition has not been examined in aged or ad cohorts. investigators hypothesize that acute higher intensity exercise will elicit a greater blood lactate response (area under the curve, auc) compared to acute moderate intensity exercise, and that this response will be greater in nd than in ad subjects. investigators further hypothesize that lactate auc will track negatively with change in cerebral glucose metabolism and cognitive performance. although investigators will focus on lactate, they will also quantify additional exercise-related biomarkers.

Eligibility criteria:
inclusion criteria: * age 60 and older * stable medication doses (\>1month) * post-menopausal * diagnosis of either nondemented (cdr 0) or probable ad (cdr 0.5 or 1 only) exclusion criteria: * inability to provide consent * diagnosis of insulin-dependent (type 1) diabetes mellitus * recent ischemic heart disease (\<2 years) * diagnosis of an clinically significant chronic disease including cardiovascular disease (cvd), other metabolic diseases (e.g., thyroid), cancer, human immunodeficiency virus (hiv), or acquired immunodeficiency syndrome * excluded from or unable to complete an mri scan * any neurological disorders that have the potential to impair cognition or brain metabolism (e.g., parkinson's disease, stroke defined as a clinical episode with neuroimaging evidence in an appropriate area to explain the symptoms). * clinically significant depressive symptoms that may impair cognition, abnormalities in b12, rapid plasma regain (rpr), or thyroid function that may impair cognition, use of psychoactive and investigational medications, and significant visual or auditory impairment
a phase ii study of imatinib versus interferon as adjuvant therapy in kit-mutated melanoma

Conditions: Melanoma

Summary: the purpose of this study is to compare the relapse free survival and overall survival of imatinib (gleevec) or high dose interferon (intron) in treating melanoma which has primary tumor and regional lymphonode (if have) removed in patients whose disease carries a c-kit mutation. it is assumed that gleevec may be more effective on relapse free survival as the adjuvant treatment compared with interferon.

if mutation tests show that the patient is eligible and they choose to participate in the study, they will be randomized and receive imatinib/interferon. each imatinib pill will be 100mg and the participants will take 4 pills once daily (400mg).participants randomized to the interferon arm will receive interferon 1500wiu/m2 d1-5 for 4 weeks followed by 900wiu ih tiw for 11 months. the following study procedures will also be performed at routine intervals throughout the course of treatment including blood tests, medical history updates, physical exams and chest/abdomen/pelvic ct examinations.participants will be on this study for one year and then be followed up to relapse or distal metastasis.

Eligibility criteria:
inclusion criteria: * melanoma patients whose primary tumor and regional lymphonodes (if have)have been resected * histologically documented ajcc stage iib to iiic * c-kit mutation documented from either primary or metastatic lymphnode site * ecog performance status 0 or 1 * age 18 years or older * creatinine \< 1.5 x uln * anc \> 1500 ul * platelets \> 100,000 ul * total bilirubin, ast, and alt \< 2 x uln * amylase and lipase \< 1.5 x uln * no prior chemotherapy or investigational drug exclusion criteria: * severe and/or uncontrolled medical disease * pregnant or nursing mothers * any other significant medical, surgical, or psychiatric condition that may interfere with compliance * patient is \< 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ * concurrent treatment with warfarin * prior treatment with c-kit inhibitor * patient with grade iii/iv cardiac problems as defined by nyha criteria * no h2 blockers or proton pump inhibitors * known chronic liver disease * known diagnosis of hiv infection * major surgery within 2 weeks prior to study entry * patient has received any other investigational agent within 28 days of first study drug dosing * chemotherapy within 4 weeks prior to study entry

Keywords: melanoma,adjuvant therapy,kit mutated melanoma
study of imaginomics predicting early surgical rates in crohn's disease

Conditions: Crohn Disease; Prognostic Model; Radiomics

Summary: crohn's disease (cd), a type of inflammatory bowel disease (ibd), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. most cd patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. predicting early-onset surgery risk is of great importance to assist launching of therapeutic strategies. we aim to establish a digital prognostic model and nomogram using radiomics, which will help clinical practice.


Eligibility criteria:
inclusion criteria: patients with a confirmed diagnosis of cd; a follow-up more than 1 year; without previous cd-associated intestinal surgeries; complete data of cte. exclusion criteria: patients without a confirmed diagnosis of cd; with incomplete data and a follow-up less than 1 year; patients have previous intestinal surgeries; patients who have never undergone cte examination.
a prospective, open-label, multi-center comparison of lymphoseek identified lymph nodes and clinically identified lymph nodes of subjects with known cancer of the anus

Conditions: Anal Cancer

Summary: prospective, open-label, within-subject, multi-center pilot study of lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.

prospective, open-label, within-subject, multi-center pilot study of lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. all subjects will receive a single dose of 50 µg lymphoseek radiolabeled with 0.5 millicurie (mci) (18.5 mbq) 99mtc.

Eligibility criteria:
inclusion criteria: * subject has provided written informed consent with health insurance portability and accountability act of 1996 (hipaa) authorization * has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus) * has a documented clinical stage using the tumor, lymph node, metastasis staging (tnm) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and pet/ct imaging evaluation of the bilateral inguinal area * is at least 18 years of age at the time of consent * has an eastern cooperative oncology group (ecog) performance status of grade 0 to 3 * if of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year exclusion criteria: * the subject has had radiation therapy, chemotherapy or immunotherapy within the 30 days prior to lymphoseek administration * has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping procedure * has a known allergy to dextran * is breast-feeding or pregnant * before the administration of lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical * has received an investigational product within the 30 days prior to lymphoseek administration
delirium screening 3 methods study

Conditions: Delirium; Critical Illness

Summary: observational study comparing three different methods of delirium detection in critically ill patients.

the delis-3 study aims to compare three different approaches to detection of icu (intensive care unit) delirium in critically ill patients. the cam-icu (confusion assessment method for the icu) and the icdsc (intensive care delirium screening checklist) have both been developed in the early 1990. the cam-icu is either positive or negative, whereas the icdsc is a score between 0-8. a score above 3 is delirium positive. neither scale has been validated as severity scales. the novel cam-icu-7 is developed from the original cam-icu and has been validated as a severity scale. detection of delirium in critically ill patients is highly necessary as delirium can be very painful to the patient. moreover, certain subtypes of delirium is associated with increased mortality and poorer cognitive outcome when patients are followed up on long term. therefore, delirium screening of all patients is standard care in most intensive care units. however, there is also a need to assess severity of delirium. the recently published cam-icu-7 has now been translated to danish and this study will explore its performance compared to the cam-icu and the icdsc. in 17 danish icu's 10 nurses will be trained in using all three instruments. each nurse will subsequently screen 10 patients each with all three instruments as part of their normal practice. the sequence of the instruments will be randomized to avoid that one instrument is favored by always being used first, second or last. for each patient the following data will be collected: sex, age, reason for hospitalization (medical, neurological, surgical/ acute, planned), ventilator treatment, ability to verbalize, rass score (sedation and agitation score) severity of disease (sms score) and time of admission. after all screenings has been collected, nurses will fill in a questionnaire on their perceptions of each scales' ability to reliably detect delirium, userfriendliness and how time consuming each scale were to use.

Eligibility criteria:
inclusion criteria: * all patients admitted to critical care units. exclusion criteria: * patients with rass score of -3, -4, -5