Kornimate/medical-research-clean huggingface dataset:
blood flow response and acute interval exercise

Conditions: Stroke; High Intensity Interval Exercise

Summary: the objective of this project is to study the cerebrovascular response to a single bout of high intensity interval exercise (hiit) in 25 individuals with chronic stroke compared to 25 age- and sex- matched healthy controls (con). we will enroll 25 young healthy adults (conyoung) as a reference group. our hypothesis is that the cerebrovascular response in individuals with chronic stroke will be significantly lower: 1) during a single bout of hiit, and 2) during the recovery immediately following and 30 minutes after hiit, compared to con. this study has 2 visits at the university of kansas medical center research in exercise and cardiovascular health laboratory. for the first visit, we will perform questionnaires about heart health, physical activity and overall health. participants will then complete a submaximal exercise test on a seated stepper. participants will also have a familiarization session to practice hiit. the second visit will include cerebrovascular measures before, during, immediately after, and 30 minutes after performing hiit.


Eligibility criteria:
chronic stroke inclusion criteria: * age 40-80 years old * treated for stroke 6 months to 5 years ago * performs \<150 minutes of moderate intensity exercise per week * able to answer consenting questions and follow a 2-step command chronic stroke exclusion criteria: * stroke etiology due to covid-19 pathology. * symptoms of covid-19 and/or positive covid-19 test within the past 3 months * unable to stand from a sitting position without physical assistance * recent joint replacement/surgery/poor motor control that limits ability to perform exercise on a recumbent stepper * insulin injection dependent diabetes * dependent on supplementary oxygen * history of other neurological disease (multiple sclerosis, alzheimer's disease, parkinson's disease) * unable to find tcd signal on the stroke-affected or non-affected mca. con inclusion criteria: * matched age ± 5 years to participant with chronic stroke * matched sex to participant with chronic stroke * performs \<150 minutes of moderate intensity exercise per week * able to answer consenting questions and follow a 2-step command con exclusion criteria: * symptoms of covid-19 and/or positive covid-19 test within the past 3 months * unable to stand from a sitting position without physical assistance * recent joint replacement/surgery/poor motor control that limits ability to perform exercise on a recumbent stepper * insulin injection dependent diabetes * dependent on supplementary oxygen * history of other neurological disease (multiple sclerosis, alzheimer's disease, parkinson's disease) * unable to find tcd signal on the right or left mca. conyoung inclusion criteria: * age 18-30 years old * low cardiac risk (defined by the american college of sports medicine) * able to find tcd signal on the right or left mca

Keywords: cerebral blood velocity cerebral autoregulation
metabolic effects of sleep extension in people with obesity

Conditions: Insulin Resistance; Obesity

Summary: this study is designed to determine the impact of extending sleep duration on glucose metabolism in people with obesity. half of the participants will be instructed to increase their time-in-bed by one hour (sleep extension; n=15) while the other half will be be instructed to maintain their current sleep habits (n=15).

restricting sleep is known to be detrimental to glucose metabolism in healthy adults. obesity is a condition associated with both lower sleep duration and poor glucose tolerance. therefore, increasing sleep duration is a potentially novel therapeutic strategy for improving glucose metabolism in this population. the investigators will assess this by determining insulin sensitivity during a hyperinsulinemic-euglycemic clamp before and after a sleep intervention in both the control and sleep extension groups.

Eligibility criteria:
inclusion criteria: * sleep \<7h/night * body mass index 25-50 kg/m2 * altered glucose metabolism (any of the following) fasting glucose 100-125 mg/dl or, 2-h plasma glucose 140-199 mg/dl during an oral glucose tolerance test (ogtt) or, hba1c 5.7-6.4% or, homeostatic model assessment of insulin resistance (homa-ir) ≥2.0 exclusion criteria: * sleep disorders 1. moderate to severe sleep apnea (apnea-hypopnea index ≥15 events/hour) 2. had ≥15 periodic limb movements per hour sleep \[plms\] 3. narcolepsy or insomnia * perform shift work * excessive caffeine or alcohol consumption * significant organ dysfunction/disease (e.g. diabetes mellitus, kidney disease) * liver disease other than metabolic dysfunction associated steatotic liver disease (masld) * prior bariatric surgery * pregnancy or breastfeeding * taking medications that can affect study outcomes (alter sleep duration or glucose metabolism) * tobacco or illicit drug use * perform intense exercise \>70 min/wk or moderate exercise \>150 min/week * excessive alcohol consumption (\>21 units of alcohol per week for men and \>14 units of alcohol per week for women)
study of effectiveness and safety of extracorporeal shock wave therapy (eswt) for treatment of painful heel syndrome

Conditions: Plantar Fasciitis

Summary: the purpose of this study is to determine if the storz duolith sd1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * ability of subject or legal respondent to give written informed consent * signed informed consent * diagnosis of painful heel syndrome * 6 months of unsuccessful conservative treatment * washout from conservative treatment * scores of 5 or greater on three vas scales * score of 3 or 4 on roles and maudsley scale * willingness to refrain from specified concomitant therapies * willingness to keep subject diaries * negative urine pregnancy test (if applicable) required use of contraception (if applicable) exclusion criteria: * tendon rupture, neurological or vascular insufficiencies * inflammation of lower and upper ankle * history of rheumatic disease, collagen, or metabolic disorders * history of hyperthyroidism * active malignant disease with or without metastasis * paget disease or calcaneal fat pad atrophy * osteomyelitis * fracture of calcaneus * immunosuppressive therapy * long term (6 months or greater) treatment with corticosteroid * insulin dependent diabetes, severe cardiac or respiratory disease * coagulation disorder or therapy with anticoagulants or antiplatelet drugs * bilateral painful heel * planned treatment within 8 weeks of enrollment that may confound pain results * less than required washout of other treatments * previous surgery for painful heel * previous unsuccessful treatment for painful heel with shock wave device * history of allergy or hypersensitivity to local anesthetics * significant abnormalities of hepatic function * poor physical condition * pregnant female * active infection or history of chronic infection in treatment area * history of peripheral neuropathy * history of systemic inflammatory disease * history of worker's compensation or litigation * participation in study of investigational device within 30 days of selection or current active study participation * in the opinion of the investigator, inappropriate for study inclusion * unwilling to comply with study requirements * implanted pacemaker, insulin pump, defibrillator, or neurostimulator * implanted prosthetic device in area of treatment * open wounds or skin rashes
effect of high dose ciclesonide on asthma control

Conditions: Bronchial Asthma

Summary: the aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. asthma control will be assessed by the asthma control questionnaire (acq).


Eligibility criteria:
inclusion criteria: * written informed consent was provided * history of persistent bronchial asthma for at least 6 months * current treatment with an inhaled corticosteroid (ics) at a stable dose in the dose range of 200-1000 μg fluticasone propionate (fp)/day or equivalent for a minimum of 12 weeks * good inhalation technique * under the current ics pre-treatment the acq score ranges between ≥ 0.75 and ≥ 2 exclusion criteria: * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation * concomitant severe diseases (e.g. malignant diseases during the past 5 years \[other than basal or squamous cell carcinoma\], hepatitis c, acquired immune deficiency syndrome \[aids\]) * diseases which are contraindications for the use of ics (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment) * use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months

Keywords: ciclesonide asthma
trial of remote evaluation and treatment of gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus; Pregnancy

Summary: diabetes in pregnancy (gestational diabetes) is becoming more common. it can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. gestational diabetes in the mother may also lead to effects on the long term health of the baby. most people today use mobile phones. our research is looking at using a mobile phone app to help with diabetes care in pregnancy. in particular, the investigators are using phones which connect to the standard blood glucose monitoring machines given to all women with gestational diabetes to see if sending the hospital team blood test results between clinic appointments can result in the need for fewer clinic visits. the investigators are also testing to see how acceptable using mobile phones in this way, is to our patients and that the control of the blood glucose and outcomes for the mother and baby are at least as good as standard care. the investigators are planning to recruit 200 women who receive care for their gestational diabetes at the oxford university hospitals nhs (national health service) trust. they will be randomised so that 100 will receive standard care, and 100 will have a mobile phone "app" linked to the blood glucose machines to send blood glucose readings directly to the diabetes care team to review. both groups will be asked to test their blood glucose levels at home regularly with a glucometer. all participants will also be given lifestyle advice to reduce the chance they will need medication. blood glucose control will be measured also by the percentage of glycated hemoglobin (hba1c) at the time of diagnosis of gestational diabetes and before delivery.


Eligibility criteria:
inclusion criteria: * pregnant women with an abnormal 75 gram 2 hour glucose tolerance test as defined by the iadpsg (international association of diabetes in pregnancy study group) * willingness and able to give informed consent * female aged between 18-40 years * singleton pregnancy * able to travel to hospital independently exclusion criteria: * impaired cognitive function such that she is unable to operate m-health equipment * any evidence of fetal compromise * known risk factors for obstetric complications, other than obesity and diabetes * gestational diabetes requiring immediate pharmacologic treatment * twins or higher order pregnancy * ogtt (oral glucose tolerance test) suggesting preexisting diabetes (fasting blood glucose \>= 7.0 or 2 hour \>= 11.1 mmol/l * gestation greater than 34+6 at the time of potential recruitment * unable to speak english well enough to explain or use equipment

Keywords: gestational diabetes mellitus m health smartphone blood glucose monitoring
a pre-market study to evaluate b.bone for posterolateral fusion (b.spine clinical trial).

Conditions: Degenerative Spinal Conditions

Summary: prospective, open-label, single-arm clinical investigation. the purpose of this clinical investigation is to evaluate the bone substitute b.bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety. subjects who meet the study selection will undergo up to a three-level posterolateral fusion using b.bone in combination with autologous bone in a 1:1 ratio. subjects will be followed up at discharge, week 6, month 3, month 6, and month 12.


Eligibility criteria:
inclusion criteria: 1. male or female patient ≥ 18 years old. 2. patients requiring posterolateral fusion treatment for degenerative thoracolumbar, lumbar, or lumbosacral spinal conditions up to 8 levels. 3. patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol. 4. patients who have provided written informed consent to participate in the study and the processing of personal data before any study procedure is performed. exclusion criteria: 1. any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s). 2. patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment. 3. indication for spinal fusion because of an acute traumatic reason, like a spinal fracture. 4. bone infection. 5. bone malignant tumor(s). 6. concomitant infectious systemic diseases, 7. inflammatory systemic diseases, 8. concomitant myeloproliferative disorders, 9. active autoimmune disease, 10. known or suspected allergy or hypersensitivity to the b.bone device components, 11. calcium metabolism disorder (i.e. hypercalcemia), 12. known hyperthyroidism or autonomous thyroid adenoma. 13. patients currently treated with systemic immunosuppressive agents. 14. patients who are currently enrolled in another clinical study that would directly interfere with the current study, except when the patient is participating in a purely observational registry with no associated treatments. 15. body mass index (bmi) larger than 36 (morbidly obese). 16. known severe osteoporosis. 17. patients requiring instrumented fusion in the cervical spine. 18. woman who is pregnant or breast-feeding.
crossover trial of ad109 in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of ad109 versus its individual components or placebo in patients with obstructive sleep apnea.

the study is designed to examine the efficacy and safety of ad109 to treat obstructive sleep apnea. the study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (psg) testing with dosing of one of the following 4 treatments: ad109, atomoxetine, r-oxybutynin or placebo. participants will return 2 weeks after their final crossover psg for an end of study (eos) visit.

Eligibility criteria:
inclusion criteria: * male or female, between 25 to 65 years of age, inclusive, at the screening visit. * ahi 10 to \<20, or ahi ≥20 if meets other psg criteria exclusion criteria: * history of narcolepsy. * clinically significant craniofacial malformation. * clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. a medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication * cpap should not be used for at least 2 weeks prior to first study psg * history of using oral or nasal devices for the treatment of osa may enroll as long as the devices are not used during participation in the study.
community-based participatory research to improve health and quality of life of latino youth: every little step counts

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight latino youth.

with the increasing prevalence of obesity, the incidence of obesity-related co-morbidities including depression and type 2 diabetes have emerged as critical public health conditions. furthermore, latinos experience a disproportionately greater burden of these obesity-related disorders. therefore, we have developed a 12-week community-based lifestyle intervention that includes weekly education sessions for children and their parents and 3 exercise sessions per week for youth. the program will be delivered at a local ymca in the greater phoenix metropolitan area.

Eligibility criteria:
inclusion criteria: * hispanic ethnicity (child and parent) * age 14-16 (child) and parent age \< 85 * bmi percentile above the 85th (child) * ability to read and speak english (child) exclusion criteria: * taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (child and (parent ogtt only)) * involved in any formal weight-loss program in the past 6 months (child) * diagnosed diabetes (type 1 or type 2 child) * weight is less than 110 ibs (child and parent)
study to observe safety and efficacy of nexavar in treatment of kidney cancer

Conditions: Carcinoma, Renal Cell

Summary: the objective of this non-interventional study is to evaluate the effectiveness \& safety of nexavar in advanced renal cell carcinoma (rcc) patients under daily-life treatment conditions based on age of the patient (older (age \>70 years) and younger patients (age \<70 years). specifically investigated are the tumor status, duration of nexavar ® treatment (number of cycles) and incidence of hand foot skin reaction.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of advanced renal cell carcinoma (rcc) and decision taken by the investigator to prescribe sorafenib exclusion criteria: * exclusion criteria must be read in conjunction with the local product information.

Keywords: sorafenib renal cell carcinoma tyrosine kinase inhibitor observational study
a bioequivalence study of the fixed dose combinations of saxagliptin/metformin xr relative to co-administration

Conditions: Type 2 Diabetes Mellitus(T2DM)

Summary: the primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male chinese subjects.

a single-centre, randomized, open-label, two-period, cross-over, bioequivalence study of the fixed dose combinations of saxagliptin/metformin xr relative to co-administration of the individual components in two cohorts of healthy chinese subjects under fed conditions

Eligibility criteria:
inclusion criteria: * chinese ethnicity which is defined as having both parents and 4 grandparents who are chinese * healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * men, ages 18 to 40 years, inclusive. the age difference among the subjects is within 10 years * weigh at least 50 kg and have a body mass index (bmi) between 19 and 24 kg/m2 * sexually active fertile men must use effective birth control throughout the study and for up to 90 days after the last dose of investigational product if their partners are women of child bearing potential exclusion criteria: * any significant acute or chronic medical illness * current or recent gastrointestinal disease * subjects that have lymphocytopenia or thrombocytopenia * history of autoimmune skin disorder * estimatedcreatinine clearance of less than 80 ml/min

Keywords: type 2 diabetes, saxagliptin, metformin,fixed dose combination tablet, bioequivalence, pharmacokinetic, safety, tolerability
mi propio camino intervention rct for blood pressure medication adherence

Conditions: Hypertension; Medication Adherence

Summary: the purpose of this study is to compare the effect of two educational interventions on adherence to blood pressure medications among adults with uncontrolled hypertension.

the study is a randomized controlled trial (rct) consisting of a 4-session educational intervention (completed over the course of 4-8 weeks) and a 6-month follow-up period for adherence monitoring. participants will be allocated to one of two educational intervention groups following a block randomization schedule, stratified on the hypothesized mediator variable of medication-related beliefs (high versus low scores on the bmq necessity-concerns subscore) to ensure the groups are balanced on this variable. primary endpoint is medication adherence at 6 month follow-up, defined as the proportion of days that the prescribed number of doses was taken by the patient during a 30-day period, measured by a pill bottle cap monitor (medication events monitoring device \[mems\]).

Eligibility criteria:
inclusion criteria are: (1) age 18 years or greater, (2) uncontrolled hypertension (bp above 140/90 mmhg), (3) hispanic ethnicity, (4) spanish or english-speaking, (5) at least one office visit at the study clinic in prior 12 months. exclusion criteria: persons with stage 4 or 5 chronic kidney disease (ckd) will be excluded.
temporal trends of thrombolysis treatment in chinese acute ischemic stroke (ais) patients from 2007-2017: analysis of china national stroke registry (cnsr) i, ii, and iii; ctp-draft review performed;

Conditions: Stroke

Summary: the present study is to be conducted based on the ais patient data collected from cnsr i, ii, and iii. the primary objectives are: * to investigate the temporal changes in the proportion of intravenous recombinant plasminogen activator (iv rtpa) treatment from 2007 to 2017 among intravenous thrombolytics (ivt) eligible patients (patient groups b and b') and overall ais patients (patient group a) in china; * to investigate the temporal changes in iv rtpa treatment time intervals from 2007 to 2017 among iv rtpa treated patients (patient groups c and c') in china. the secondary objectives are: - to describe the demographic and clinical characteristics of the iv rtpa treated patients (patient groups c and c'), ivt eligible patients (patient groups b and b') and the overall ais patients (patient group a) from 2007 to 2017 from the cnsr i to iii.


Eligibility criteria:
inclusion criteria: * patient group a: all ais patients * aged 18 80 years * diagnosed with ais on admission * patient groups b and b': ivt eligible patients * met the in- and exclusion criteria of "all ais patients" * arrived at hospital within 2 h (patient group b) or 3.5 h (patient group b') of symptom onset * patient groups c and c': iv rtpa treated patients * met the in- and exclusion criteria of "ivt eligible patients" * treated with iv rtpa within 3 h (patient group c) or 4.5 h (patient group c') of symptom onset exclusion criteria: * patient group a: all ais patients * missing baseline data including age and gender * diagnosed with intracranial hemorrhage (ich), transient ischemic attack (tia), subarachnoid hemorrhage (sah), or unspecific stroke * arrived at hospital after 7 days of symptom onset * patient groups b and b': ivt eligible patients * missing key data including: i. symptom onset time (or last known well time) ii. hospital arrival time iii. whether received ivt treatment or not iv. the time of ivt treatment * documented ivt absolute contraindications, according to the case report form (crf) for each wave of cnsr * patient groups c and c': iv rtpa treated patients * not received ivt * received ivt other than rtpa * treated with iv rtpa after 3 h (patient group c) or 4.5 h (patient group c') of symptom onset * received additional treatments with intra arterial reperfusion or experimental therapies