Kornimate/medical-research-clean huggingface dataset:
fujian province cardiovascular diseases study

Conditions: Cardiovascular Diseases

Summary: this proposal delineates a research plan to collect blood from the patients with cardiovascular diseases for the purpose of establishing a molecular biological bank registry. the fujian provincial hospital will enroll 8,000 patients.the blood collected will be processed to create a repository of molecular biological plasma. along with a sample of blood collected from individual patients, a concise general medical history, demographic data, electrocardiographic data, echocardiographic data, and laboratory data will be collected. a short interview will take place after enrollment during the outpatient visit or hospital stay, or may be conducted via phone call after enrollment. all the clinical data gathered will be compiled in fujian provincial hospital center database, and would be stored in a format where a culmination of clinical findings, i.e. representing a disease of interest, can be used to search the database to identify the blood samples of all patients with such characteristics for further study.

the study is to commence on may 1st 2015 and is to be completed within 3-5 years. the targeted number of patients to be enrolled is 8,000. all patients have the history of cardiovascular diseases, will be eligible to be enrolled. patients inclusion criteria are as follows, once informed consent is obtained: 1. males or females at least 18 years old. 2. patient has not been previously enrolled in the molecular biological bank registry of the fujian provincial hospital. 3. patient able to give informed consent. 4. any patient with history of cardiovascular diseases (if a subject reports history of cardiovascular diseases at another facility, outside records will be obtained to confirm the diagnosis.

Eligibility criteria:
inclusion criteria: * 18-80 year old males and non-child-bearing period females. * clinical diagnosed with acute coronary syndrome including nste-acs ,mi and stemi. * patients with stemi((st segment elevation myocardial infarction) and nstemi(non-st segment elevation myocardial infarction) will be recruited within 48 hours of symptom onset. * patients with cerebrovascular disease was made or confirmed by a board-certified neurologist with fellowship training in cerebrovascular disease and confirmed by standard diagnostic techniques such as head ct, mri, mr angiography, ct angiography, carotid ultrasound, etc. * sign the icf(inform consent form) exclusion criteria: * child-bearing women * hypothyroidism, * active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times uln(upper limit of normal) * severe anemia (hemoglobin,hematocrit \< 28%) * a history of psychiatric disorders * a history of jejunoileal bypass or gastric bypass surgery * currently take steroids therapy * diagnosed with malignant within 5 years * severe renal function damage (creatinine clearance rate\<30 ml/min)

Keywords: cardiovascular diseases vascular diseases acute coronary syndrome chest pain heart diseases myocardial ischemia pathologic processes
clinical performance evaluation of the neumodx™ ebv quant assay 2.0 in immunocompromised transplant patients

Conditions: EBV Viremia

Summary: the neumodx ebv quant assay 2.0 study is a multi-center, observational clinical investigation designed to evaluate the performance of the neumodx ebv quant assay 2.0 in quantifying epstein-barr virus (ebv) dna levels in plasma samples from immunocompromised transplant patients. the study compares the neumodx ebv assay's performance against an fda-cleared comparator assay under routine clinical use conditions, utilizing both the neumodx™ 96 and neumodx™ 288 molecular systems. the aim is to demonstrate the quantitative concordance and clinical utility of the assay in monitoring ebv dna levels as part of patient management.

this study is an observational, multi-center, open-labeled, prospective, and retrospective clinical evaluation aimed at assessing the performance of the neumodx ebv quant assay 2.0 on the neumodx™ 96 and neumodx™ 288 molecular systems. plasma samples are collected from immunocompromised patients undergoing solid organ transplant (sot) or hematopoietic stem cell transplant (hsct) who are at risk of ebv infection or reactivation. the study includes both fresh and frozen plasma specimens obtained as part of routine clinical care. the primary objective is to demonstrate the quantitative concordance of the neumodx ebv assay when compared to the cobas® ebv assay (roche diagnostics corporation) using a predefined set of performance criteria. the study also assesses the equivalence of performance between the two neumodx systems (neumodx™ 96 and neumodx™ 288) in quantifying ebv dna levels across a range of clinical specimens. secondary objectives include evaluating the assay's performance across different viral load concentrations and subgroups.

Eligibility criteria:
inclusion criteria: * immunocompromised transplant patients (solid organ transplant (sot) or hematopoietic stem cell transplant (hsct)). * fresh and frozen plasma specimens derived from whole blood collected with edta as an anticoagulant. * residual fresh or frozen edta plasma specimens obtained from routine testing, including specimens collected from the same subject at different timepoints. * sufficient sample volume 1.6- 2.0 ml for testing with 2 assays plus discordant testing. * edta plasma samples have been stored under the following conditions: * 2-8° c up to 7 days and/or -20° c +/- 2° c or colder for up to 6 months following the separation of plasma from whole blood. or fresh edta plasma samples that have not been stored loaded onto the neumodx™ system immediately after they have been separated from whole blood. * frozen samples have not gone through more than two freeze/thaw cycles. exclusion criteria: * specimens not collected according to the manufacturer's instructions or study protocol. * lack of clear subject identification or label on a residual plasma sample * unable to obtain required medical chart information. * obvious physical damage to the residual sample. * specimens that have remained onboard the neumodx system for longer than 8 hours prior to processing.
study to assess the efficacy and safety of ublituximab in combination with umbralisib and venetoclax compared to ublituximab in combination with umbralisib in subjects with cll (ultra-v)

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: ultra-v: study to assess the efficacy and safety of ublituximab in combination with umbralisib and venetoclax (u2-v) compared to ublituximab and umbralisib (u2) in subjects with chronic lymphocytic leukemia (cll)

this is an open-label, multicenter, phase 2/3 study to evaluate the efficacy and safety of the combination of ublituximab + umbralisib + venetoclax (u2-v) compared to the combination of ublituximab + umbralisib (u2) in participants with either treatment naïve or previously treated cll/ small lymphocytic lymphoma (sll).

Eligibility criteria:
inclusion criteria: * chronic lymphocytic leukemia (cll)/ small lymphocytic lymphoma (sll) that warrants treatment * adequate organ system function as specified in the protocol * ability to follow protocol procedures. exclusion criteria: * subjects receiving cancer therapy or any investigational drug within 21 days of cycle 1, day 1 * prior exposure to any pi3k inhibitor or venetoclax * autologous hematologic stem cell transplant within 6 months of study entry. prior allogeneic hematologic stem cell transplant is excluded * active hepatitis b or hepatitis c.

Keywords: cll sll
spark symptom screening and feedback to providers

Conditions: Pediatric Oncology; Quality of Life

Summary: supportive care prioritization, assessment and recommendations for kids (spark) is a web-based application which builds upon the symptom screening in pediatrics tool (sspedi) and consists of two components: (1) a symptom screening component centered on sspedi; and (2) a supportive care clinical practice guideline (cpg) component. this proposal is a randomized controlled trial that compares daily completion of sspedi via spark for 5 days with symptom feedback to healthcare providers compared with standard of care

participants will be children with cancer or hematopoietic stem cell transplantation (hsct) recipients who are 8-18 years of age and who can understand english, and who are expected to be in hospital or in clinic daily for 5 days. this will be a multi-center rct in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. the primary outcome will be the self-reported day 5 total sspedi score (range 0-60; higher worse). secondary outcomes will be the day 5 self-reported individual symptom, pain and qol scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. we will enroll 345 participants over 4 years from 7 canadian centers

Eligibility criteria:
inclusion criteria: * 8 to 18 years of age * diagnosis of cancer or have received or about to receive hsct * understand english * expected to be in hospital or clinic for 5 day exclusion criteria: * illness severity * cognitive disability * visual impairment

Keywords: pediatric oncology randomized control trial symptom screening quality of life
vaginal progesterone for the prevention of preterm birth in twins

Conditions: Premature Birth; Twin Pregnancy

Summary: this trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.

randomised studies in singleton pregnancies suggest that the risk of preterm birth can be decreased by using of progesterone. however, in twin pregnancies, no significant reduction in preterm birth has been demonstrated in any trial. one explanation for the lack of benefit of progesterone in previous twin studies may result from a suboptimal dosage. the investigators therefore hypothesize that progesterone dosages that are sufficient for singleton pregnancies are insufficient for twins and this is likely to be one of the reasons why prophylactic progesterone has failed to reduce preterm birth in twins. another possible explanation for the negative findings in previous twin studies may result from administration beginning too late in the second-trimester. it is thought that the mechanism of preterm birth in twin pregnancies is more strongly related to exaggerated uterine distension, which may override any benefit of progesterone on the cervix after a threshold has been reached. it is also plausible that cervical shortening occurs earlier in twin pregnancies than with singletons, and that treatment is required before a threshold of shortening is reached or before any inflammation-mediated component to the initiation of preterm birth has been established as the biological mechanisms by which preterm birth occurs differ from those in singleton pregnancies.

Eligibility criteria:
inclusion criteria: * age \> 18 years * dichorionic diamniotic (dcda) pregnancies * live fetuses at 11-13 weeks of gestation, * informed and written consent exclusion criteria: * high-risk for aneuploidies, * pregnancies complicated by major fetal abnormality identified at the 11-13 weeks or 20-24 weeks assessment, * hypersensitivity to progesterone, * women taking progesterone regularly or at any time within the previous 7 days, * concurrent participation in another drug trial or at any time within the previous 28 days, * women who are unconscious or severely ill, those with learning difficulties, or serious mental illness, * any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.

Keywords: progesterone
review of isolated hypoganglionosis and presentation of a new case complicated with sigmoid volvulus

Conditions: Pathology; Sigmoid Volvulus; Hypoganglionosis

Summary: isolated hypoganglionosis is rare and constitutes 3-5% of all congenital neurological bowel diseases. since hypoganglionosis is associated with symptoms such as chronic constipation or pseudo-obstruction, it can be confused with hirschprung's disease and it is important to make a differential diagnosis before treatment. our aim in this study; in addition to sharing the rarely isolated hypoganglionosis and sigmoid volvulus in a 45-year-old male patient with mental retardation, the investigators present a systematic comprehensive review of hypoganglionosis.

isolated hypoganglionosis is rare and constitutes 3-5% of all congenital neurological bowel diseases. since hypoganglionosis is associated with symptoms such as chronic constipation or pseudo-obstruction, it can be confused with hirschprung's disease and it is important to make a differential diagnosis before treatment. our aim in this study; in addition to sharing the rarely isolated hypoganglionosis and sigmoid volvulus in a 45-year-old male patient with mental retardation, the investigators present a systematic comprehensive review of hypoganglionosis. pubmed and scopus databases were scanned. no restrictions were used in the written language. only isolated cases of hypoganglionosis were added to the study. in the cases; author, year of publication, country of publication, age, gender, surgical or non-surgical treatments, treatment results, and mortalities were examined. when sigmoid volvulus is seen in children and adolescents, congenital neurological bowel diseases should be considered in the differential diagnosis. hirschprung's disease must be ruled out by rectal biopsy. the histopathological investigation should be carried out for the diagnosis and determination of surgical margins in isolated hypoganglionosis.

Eligibility criteria:
inclusion criteria: * isolated hypoganglionosis * our case of isolated hypoganglionosis exclusion criteria: * hypoganglionosis with hirschsprung's disease

Keywords: colon constipation derotation obstruction hypoganglionosis intestinal neuronal dysplasia
a research study to see how well cagrisema helps people in east asia with excess body weight lose weight

Conditions: Obesity or Overweight

Summary: this study will look at how well the new medicine cagrisema helps people with excess body weight lose weight compared to another medicine, semaglutide. the participants will receive one injection once a week. the study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. the study will last for about 1½ years.


Eligibility criteria:
inclusion criteria: * male or female * age greater than to or equal 18 years at the time of signing informed consent * a) body mass index (bmi) greater than or equal to 27.0 kilograms per square meter (kg/m\^2) with greater than or equal to 2 obesity-related complications or b) bmi greater than or equal to 35.0 kg/m\^2 with greater than or equal to 1 obesity-related complication. at least one complication should be hypertension, dyslipidaemia or t2d diabetes-related for participant with t2d * diagnosed with t2d greater than or equal to 180 days before screening * hba1c 7.0-10.0 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by central laboratory at screening * treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (oad)s (metformin, α-glucosidase inhibitors \[agi\], glinides, sodium-glucose cotransporter 2 inhibitor \[sglt2i\]), thiazolidinediones, or sulphonylureas \[su\] as a single agent or in combination) according to local label * treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening exclusion criteria: obesity-related - treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening glycaemia-related for participant without t2d * hba1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening * history of type 1 or type 2 diabetes diabetes-related for participant with t2d * renal impairment with estimated glomerular filtration rate (egfr) lesser than 30 milli liter per min/1.73 meter square (ml/min/1.73 m\^2) as measured by central laboratory at screening * clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
effect of hearing loss and vestibular decline on cognitive function in older subjects

Conditions: Hearing Loss, Sensorineural; Bilateral Vestibulopathy; Alzheimer Disease; Mild Cognitive Impairment

Summary: the world population has been growing and aging dramatically, with a rising prevalence of dementia. worldwide, around 50 million people have dementia, with 10 million new cases added every year. despite the epidemic scale of dementia, until now no cure or disease-modifying therapy has been identified. therefore, the world health organization (who) has recognized dementia as a public health priority. several large studies have demonstrated that hearing impairment is associated with a greater risk of cognitive impairment. hearing rehabilitation could potentially provide a disease-modifying therapy to delay cognitive decline. although auditory behavioral research has not yet revealed a reliable indicator of early cognitive impairment, cortical-evoked auditory potentials (caep) have shown promising evidence as a non-invasive way to identify early-stage cognitive impairment. the peripheral vestibular apparatus is located in the inner ear and codes rotation and translation of the head to preserve a stable view. increasing evidence suggests that bilateral vestibular function loss, also known as bilateral vestibulopathy (bvp), leads to hippocampal atrophy and reduced spatial cognitive skills, as well as structural and functional alterations in parieto-insular and parieto-temporal regions. many studies have demonstrated that vestibular function declines with age. vestibular dysfunction can be linked to reduced topographical orientation and memory and has been suggested as a risk factor to ad, due to increased risk of falling and deficits in activities of daily life (adl). our first aim is to study the effect of snhl and vestibular decline on caep, spatial and non-spatial cognitive functioning and trajectories in cognitively healthy older subjects, as well as patients with mild cognitive impairment (mci) and ad. our second aim is to study if mri brain volume changes can be observed in the hippocampus, entorhinal cortex, and auditory and vestibular key regions in these populations and correlate with caep and cognitive functioning. the expected outcome is important to society because it will provide data from a cognitive assessment protocol adapted for a potentially hearing-impaired population, objective outcome measures (incl. caep and mri brain volume changes) to identify older subjects with snhl and bvp at risk for cognitive decline, and will support screening and interventional studies to assess the impact of rehabilitation on slowing down cognitive decline.


Eligibility criteria:
inclusion criteria: * mini mental state examination \> 12 * dutch-speaking exclusion criteria: * uncorrectable visual impairment * hearing implants * hearing aids
development and validation of a self-administered questionnaire to identify levers of adhesion behavior to patient's medication in order to adapt the educational monitoring.

Conditions: Patient Education as Topic; Surveys and Questionnaires; Medication Adherence; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus, Type 2; Heart Failure

Summary: medication non-adherence is an economic problem and a major public health challenge. factors influencing medication adherence can be modelled according to five dimensions: disease, medication, patient and its close relatives, demographic and socioeconomic factors and health care system. a tool is needed to qualify medication adherence in order to adapt tailored support for individual patients to promote and optimize adherence to therapy. the objective of this work is to present the preliminary results of quilam project which is divided into 3 phases: 1. development of a tool to assess barriers to medication adherence in chronic patient (copd, heart failure, type 2 diabetes) ; 2. validation of the instrument (especially against clinical criteria) ; 3. evaluation of the sensitivity of the tool during educational interventions.


Eligibility criteria:
inclusion criteria: * patient with at least one of the following pathologies: diabetes type ii, copd, heart failure * person available for a follow-up of 1 year * affiliated to the social security or recipient of such a regime exclusion criteria: * persons referred to in articles l1121-5 and l1121-8 in the french public health code * patient who do not speak french

Keywords: surveys and questionnaires patient education as topic medication adherence pulmonary disease, chronic obstructive diabetes mellitus, type 2 heart failure
the effect of pd01 on cardiovascular health and microbial environment

Conditions: Overweight; Obesity

Summary: this randomized, placebo-controlled trial aims to determine the effects of daily administration of a carotenoid-producing bacillus strain pd01 over a 6-week period on cardiovascular health biomarkers, microbiota composition and functioning and intestinal barrier function in overweight subjects.


Eligibility criteria:
inclusion criteria: * overweight men/women (bmi 25-35 kg/m2) * healthy individuals * age between 18 and 70 years * fasting glucose \< 7.0 mmol/l * normal hba1c (4.4 to 6.2%) exclusion criteria: * type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/l); * history of (severe) cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, heent (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. * abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator) * use of medication interfering with endpoints * use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine * administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study * use of antibiotics in the 90 days prior to the start of study * known pregnancy, lactation * abuse of products; alcohol (\> 20 alcoholic consumptions per week) and drugs * smoking * blood donation within 3 months before study period * plans to lose weight or following a hypocaloric diet during the study period; * weight gain or loss \> 3 kg in previous 3 months * high physical activity (\>4.5 hours of running/week) * hormone replacement therapy (women) * history of any side effects towards intake of pro- or prebiotic supplements of any kind * history of any side effects towards intake of carotenoids * prohibited use of pro-, pre- or synbiotics during study period and from one month prior to start of study. * high intake of fruits and vegetables (more than the 75th percentile of dietary intake of fruits and vegetables) * vegetarians/vegans

Keywords: carotenoid bacillus microbiota cardiovascular health