Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic behavior of phenolic acids derived from black tea

Conditions: Cardiovascular Diseases

Summary: this study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.


Eligibility criteria:
inclusion criteria: * healthy males * not smoking exclusion criteria: * use of nsaids and/or antibiotics * no blood donation 1 months prior to screening

Keywords: black tea phenolic acids
hemodynamics response to upper airway obstruction in marfan syndrome

Conditions: Sleep-disordered Breathing; Snoring

Summary: upper airway obstruction (uao) is an unrecognized source of hemodynamic stress that may contribute to aortic adverse events in persons with marfan syndrome (mfs). uao occurs during snoring and sleep apnea and is characterized by repetitive partial or complete obstruction of the upper airway during sleep. these obstructive breathing events lead to intermittent surges in blood pressure (bp) ref and large decreases in pleural pressure (pes), thereby increasing the trans-mural aortic pressure (tmp) and imposing mechanical stress on the aorta during sleep. although uao is known to increase mechanical stress on the aorta, the magnitude of the increase is not known for persons with mfs. in this project, therefore, the investigators will also examine the changes in pes and bp responses in periods of obstructed breathing and compare the diurnal markers or vascular stress between baseline and cpap studies in mfs persons.

research objective/significance: specific aim 1a: to quantify the pes and bp during periods with and without uao during sleep in persons with mfs. specific aim 1b: to examine the effect of cpap treatment of uao on pes and bp in mfs persons. specific aim 2: to examine the effect of cpap treatment of uao on daytime markers of hemodynamic stress (augmentation index, reactive hyperemia index) in mfs persons. primary outcomes: * overnight measure of hemodynamic stress (blood pressure, pleural pressure swings) secondary outcomes: * changes in diurnal markers of hemodynamic stress (augmentation index, reactive hyperemia index)

Eligibility criteria:
inclusion criteria: people with marfan syndrome. * age ≥ 18yrs * able and willing to provide informed consent * willing to sleep connected to research apparatus exclusion criteria: * unstable cardiovascular disease (chf, myocardial infarction or revascularization procedures, and unstable arrhythmias) * uncontrolled hypertension (bp \> 190/110) * underlying obstructive or other intrinsic lung disease * renal failure on dialysis * cirrhosis * pregnancy
changing diabetes in children

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this study is conducted in asia. the primary objective of the cdic programme is to improve access to comprehensive diabetes care among the children with diabetes from the economically underprivileged section of the population and to establish a registry for this group of children with type 1 diabetes in india.


Eligibility criteria:
inclusion criteria: * children diagnosed with type 1 diabetes * parents/caretakers agree to participate in the study * child belongs to the below poverty line economic strata (centre director certifies economic status for inclusion in to the study) exclusion criteria: * children with type 2 diabetes * children from higher economic status * those getting coverage under other government / private schemes
caffeine for apnea of prematurity-sleep (cap-s) study

Conditions: Apnea of Prematurity

Summary: apnea of prematurity is a common condition that is usually treated with methylxanthines. methylxanthines are adenosine receptor blockers that have powerful influences on the central nervous system. however, little is known about the long-term effects of methylxanthines on the developing brain. the caffeine for apnea of prematurity-sleep (cap-s) study is a sub-study of the main caffeine for apnea of prematurity (cap) trial, an international placebo-controlled randomized trial of methylxanthine therapy for apnea of prematurity. this sub-study is designed to take advantage of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive either caffeine or placebo, and are currently receiving detailed neurocognitive and behavioral assessments in the cap trial.

the use of methylxanthines as therapy for apnea of prematurity may be a double-edged sword. although widely-used, and efficacious for treatment of apnea of prematurity, long-term drug effects have not been rigorously studied. neonatal methylxanthine therapy may have long-term impacts on sleep organization and ventilatory control. the cap trial, funded by the canadian institutes of health research, was initiated due to the paucity of well-controlled data on the long-term effects of methylxanthines in preterm infants. the initial cap trial was a multicenter, randomized, placebo-controlled trial of caffeine vs placebo as treatment for apnea of prematurity with follow-up to a corrected age of 18 months. 2,006 infants were enrolled. the cap trial found that methylxanthines reduced the rates of bronchopulmonary dysplasia (bpd) and cerebral palsy (cp), and did not affect mortality. however, concerns remain regarding long-term sequelae of methylxanthine use. the canadian institutes of health research have therefore funded further follow-up of the entire cap trial cohort to age 5 years, corrected for prematurity. the key objectives of this study are to examine the impact of methylxanthines on neurocognition and behavior. this ongoing parent study provides an opportunity to determine potential long-term effects of methylxanthines on sleep disorders, and to correlate these findings with daytime functioning. our overall hypothesis is that methylxanthine use in preterm infants, while beneficial in the short term, results in longstanding abnormalities in the regulation of sleep, and breathing during sleep.

Eligibility criteria:
inclusion criteria: * males or females aged 5-7 years who are enrolled in the cap trial. * parental/guardian permission (informed consent) and if appropriate, child assent.

Keywords: preterm infants very low birthweight apnea of prematurity methylxanthines sleep disturbance obstructive sleep apnea syndrome polysomnography sleep disruption
effectiveness of high dose vitamin d supplementation in stage iii colorectal cancer

Conditions: Colon Cancer; Rectal Cancer

Summary: this is a pilot study to test whether there is an association between baseline vitamin d levels, vitamin d supplementation and survival in patients with stage iii colon and stage ii/iii rectal cancer receiving chemotherapy. 70 patients with colon stage iii or rectal stage ii or iii cancer that require chemotherapy will be screened and 60 patients will be enrolled. patients will be randomized to standard dose (2000 iu daily) or high-dose (50,000 iu weekly) vitamin d supplementation for 1 year after initiation of chemotherapy. patients' vitamin d levels will be checked throughout supplementation then followed for 5 years with occasional vitamin d testing and surveying in order to collect information on recurrence and survival outcomes.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * willing to stop herbal medications as directed by physician * willing to stop current supplemental vitamin d (multivitamin with vitamin d component is acceptable) * willing to travel to legacy health/ohsu facility if necessary * agree to attend study visits outside of standard of care visits, if necessary * diagnosed with stage iii colon or stage ii/iii rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started * baseline serum vitamin d level below 52 ng/ml exclusion criteria: * ≤ 18 years of age * colon cancer stages i-ii and iv or rectal cancer stage i or iv * patients who do not undergo chemotherapy * patients with prior chemotherapy for this cancer * no other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for \> 3 years * unable to comply with protocol * unable to provide written informed consent * unwilling or unable to stop oral supplemental vitamin d * patients taking high-dose vitamin d supplementation (50,000 iu weekly) prior to enrollment * patients with vitamin d levels above 52 ng/ml at baseline testing * patients with hypercalcemia and/or any condition resulting in malabsorption * investigator does not believe study participation, for any reason, is in the best interest of the patient

Keywords: vitamin d
a population-based cohort of osteoarthritis: the xiangya osteoarthritis study

Conditions: Osteoarthritis

Summary: the purpose of this study is to examine the natural history, phenotypes and risk factors of osteoarthritis (oa) and pain at different joints, and to examine the association between oa structure changes, inflammation and pain for knee and hand oa.

objectives: 1. to understand the natural history of osteoarthritis (oa) at different joints (knee, hip, hand, foot and lumbar). 2. to identify different phenotypes of oa (e.g., generalized oa, rapidly progressive knee and hand oa, tibiofemoral oa and patellofemoral oa), their association with pain (e.g., peripheral pain, central pain, nociceptive pain and neuropathic pain) and consequences. 3. to examine risk factors of oa (lifestyle habits, nutritional, metabolic, anatomical and genetic factors, etc.) at each joint as well as multiple joints. 4. to determine the association between x-ray structure change, ultrasound synovial changes and pain and other symptoms of oa at knee and hand joints within the large-sample community-based population. 5. to predict the progression of knee and hand oa within new-onset early-stage knee and hand oa patients, and to identify the rapidly progressive knee and hand oa phenotypes and their related risk factors. 6. to investigate the association between gut microbiota and oa. 7. to investigate the association between oral microbiota and oa. design: this is a prospective community-based cohort study. participants: subjects included in this study were a randomly selected sample of residents, aged 50 years or older from rural mountainous communities of longshan county, hunan province, china. 4000 people were planned to be recruited, divided into three sub-cohorts. 1,469 participants were enrolled in sub-cohort 1 in 2015, and two follow-ups have been completed in 2016 and 2017. 1,267 participants were enrolled in sub-cohort 2 in 2018. 1,340 participants were enrolled in sub-cohort 3 in 2019. each sub-cohort will be followed every three years regularly.

Eligibility criteria:
inclusion criteria: 1. 50 years old or above 2. residents of the randomly selected communities exclusion criteria: 1. inability to give informed consent 2. terminal or mental illness 3. pregnant women

Keywords: osteoarthritis cohort study population-based
effect of glucosamine or ibuprofen combined with physical training in patients with knee-osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: the investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis. the investigators would like to elucidate whether treatment with glucosamine or nsaid interact with the effects of exercise in osteoarthritis patients.


Eligibility criteria:
inclusion criteria: * age 50 to 70 years * bilateral tibiofemoral osteoarthritis of the knee on x-ray * american college of rheumatology (acr) clinical classification criteria exclusion criteria: * severe health problems such as cardiovascular disease, active cancer, diabetes, kidney or liver diseases * excess alcohol use (\> 21 alcoholic drinks per week) * severe overweight (bmi \> 35) * history of injury or operation in the knee, planned knee-joint replacement, other rheumatologic diseases, previous gastric ulcer, allergy to the contents of ibuprofen or glucosamine, regular strength training prior to the inclusion

Keywords: knee osteoarthritis exercise strength training glucosamine dietary supplement ibuprofen nsaid
intrathecal morphine for unilateral total knee arthroplasty

Conditions: Primary Osteoarthritis of Knee Nos

Summary: this study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.

intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. however there are some limitations such as nausea, vomiting, pruritus, dizziness. nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration. this study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.

Eligibility criteria:
inclusion criteria: * aged more than 18 years old undergoing unilateral total knee arthroplasty * american society of anesthesiologists physical status classification 1-3 exclusion criteria: * participants deny to enroll the study * allergy to local anesthetics, opioid and nsaids * hepatic disease * contraindication for neuraxial block or adductor canal block * uncontrolled cardiovascular disease * creatinine clearance less than 50 ml/min

Keywords: intrathecal morphine, total knee arthroplasty
what treatment for patients with phlebitis or pulmonary embolism ?

Conditions: Venous Thrombosis or Pulmonary Embolism

Summary: the objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions.

venous thromboembolism (vte) is the third leading cause of cardiovascular death, with an increase in annual incidence with age. with the advent of direct oral anticoagulants, the management of deep vein thrombosis and pulmonary embolism has evolved in recent years and these treatments are widely prescribed. there are studies comparing the different anticoagulant treatments used in venous thrombosis, which show no inferiority of treatment (injectable or oral) compared to others. drug delivery modalities have been shown to affect adherence, and thus treatment efficacy. it seems fundamental to focus on patients' drug preferences in vte to ensure the best possible compliance. these preferences seem to depend on the personal history of each patient. in addition, no studies have been conducted on patient preferences for anticoagulant therapy for vte: this is the goal of the "anticoagchoice" study.

Eligibility criteria:
inclusion criteria: * patients with deep vein thrombosis, superficial vein thrombosis, muscle vein thrombosis or pulmonary embolism, over 18 years of age. no exclusion criteria

Keywords: deep vein thrombosis superficial vein thrombosis anticoagulant patient compliance preference venous thrombosis pulmonary embolism
cognitive rehabilitation with c8 sciences

Conditions: Stroke; Brain Injuries

Summary: c8 sciences program is a cognitive training program mainly developed for the students, and the effectiveness is well established. the aim of this trial is to assess clinical efficacy of the program for cognitive rehabilitation of the patients with stroke or brain injury.


Eligibility criteria:
inclusion criteria: * participants with stroke or brain injury * cognitive deficits exclusion criteria: * uncontrolled medical comorbidities * not able to perform outcome measurements * aphasia, which hamper communication * pre-diagnosed psychological or other neurological disease not relevant to stroke or brain injury
efficacy of traditional chinese medicine combined with omeprazole in patients with non-erosive reflux disease

Conditions: Non-erosive Reflux Disease

Summary: this is a double-blind,randomised,placebo-controlled clinical trial.we would like to investigate the safety and efficacy of jianpi qinghua granule(a chinese herbal compound) combined with half-dose omeprazole in treatment of non-erosive reflux disease(nerd).

this is a double-blind,randomised,placebo-controlled clinical trial.we recruit patients that suffer from non-erosive reflux disease and then divide them into two groups:treatment group and control group.treatment group take jianpi qinghua granule and half-dose omeprazole for 4 weeks,control group take a normal dose of omeprazole for 4 weeks.finally we investigate the safety of jianpi qinghua granule combined with half-dose omeprazole in treatment of non-erosive reflux disease(nerd),and contrast the efficacy of jianpi qinghua granule with omeprazole.

Eligibility criteria:
inclusion criteria: * aging between 18 and 75 years, able to read and write chinese; * meet the criteria of diagnosis of nerd * gerd q score\>=8 * meet the tcm diagnosis of syndrome of dampness-heat due to spleen deficiency * receiving no other treatments during the study; * voluntarily agreeing with the study protocol and signing a written informed consent. exclusion criteria: * gastro-duodenal ulcer * infections, inflammations, or obstruction of the small or large intestine * history of gastrointestinal cancer, or prior surgery of the stomach or intestine * females who are pregnant or those lacking adequate contraception * unwilling to sign the informed consent
effects of l-carnitine on hypothyroidism

Conditions: Hypothyroidism

Summary: l-carnitine and thyroid hormone tended to antagonize reciprocally in human body. urinary excretion of l-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of l-carnitine. the investigators hypothesized that supplying l-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. therefore, the investigators planned to compare the efficacy of l-carnitine and placebo in hypothyroid patients who had taken levothyroxine.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypothyroidism with fatigue symptom * currently use of the same amount of levothyroxine over at least six months * normal serum free t4 level exclusion criteria: * current smoker * serum hemoglobin level of under 12mg/dl * clinical diagnosis of diabetes mellitus or fasting serum glucose level ≥ 126mg/dl or hba1c level ≥ 6.5% * history of significant heart failure * history of large amount of alcohol consumption * uncontrolled hypertension (systolic blood pressure ≥ 160 millimeter of mercury (mmhg) or diastolic blood pressure ≥ 100 mmhg * pregnant, or planning to be pregnant, or breast feeding women * aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≥ 2 times of normal limit * serum cr level \> 2.0mg/dl
virtual ward-assisted very early discharge of low-risk stemi patients: the valiant-stemi trial

Conditions: Cardiovascular

Summary: observational studies have suggested that early discharge (24hrs with follow up virtually by telephone) of patients who are low risk and have had successful treatment following st elevation myocardial infarction is safe. this has not been tested in a randomised controlled trial. in this trial the study team propose to identify low risk patients and randomise them to usual care or early discharge and follow up virtually by telephone. the primary endpoint would be readmission to hospital or all cause death up to 30 day following the event. if the outcome is positive, the study will assist early discharge of patients, reduce length of stay, potentially improve patient well being and have positive financial implications for the health service


Eligibility criteria:
inclusion criteria: * successful revascularisation following stemi * zwolle score \<=3 * no bystander disease awaiting inpatient intervention at the time of screening or consent (so if they have had intervention to a bystander vessel before this they would be eligible) exclusion criteria: * haemodynamic instability (killip class \>i) * left ventricular ejection fraction \<45%\<40% * sustained ventricular or atrial arrhythmias requiring intervention * no support at home or social or physical circumstances preventing early discharge * unable to use home monitoring equipment * unwilling to consent or follow instructions * patients visiting from out of our catchment area * out-of hospital cardiac arrest * patients repatriated to their local hospital within 24 hours * new or worsening renal failure (i.e. creatinine \>=1.5x baseline)
cognitive behavioral social skills training in early onset psychosis

Conditions: Schizophrenia; Schizoaffective Disorder; Psychosis NOS

Summary: cognitive-behavioral therapy (cbt) and social skills training (sst) are recommended psychological interventions to improve symptomatology and functional recovery in psychosis. in addition, cbt may reduce hyperactivation of the brain structures responsible for the stress response. in patients with early onset psychotic disorder (eop) there are not any previous controlled study that has analyzed the efficacy of this type of intervention. the aim of this study is to investigate efficacy of cbt + sst in symptomatic and functional improvement after the treatment in patients with eop. the study will also examine the potential effect of the intervention on neurobiological stress markers.

early-onset of psychotic disorders (eop), and especially schizophrenia, is associated with a worse clinical and psychosocial evolution than in the adult form of the illness. in the case of patients with eop, international and national clinical guidelines recommend the combination of pharmacological treatment with cbt. however there are not any previous controlled study that has analyzed the efficacy of this type of psychological intervention. a controlled randomized study will be carry out of cbt + sst intervention compared to a control intervention of the same duration, format and contact with a therapist. the sample will be 30 participants with a diagnosis of schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified diagnosed between 9 and 18 years. patiens have to be in the early phase of the disease (first 5 years after the onset) and in non-acute treatment. all participants will be evaluated before and after the intervention with clinical scales, neuropsychological battery and blood test(...). 20 healthy subjects paired by age, puberal stage and sex will be also recruited and evaluated only at baseline point. the evaluations will be carried out by blind evaluators. intention-to-treat analysis will be carry out using the statistical package spss v 20.

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of non-affective psychotic disorder diagnosed between age of 9 and 18 (schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified according to dsm-v criteria). * critical period after the first psychotic episode (which covers the first 5 years) and in non-acute treatment exclusion criteria: * iq \<70 * toxic dependence comorbid disorder * presence of neurological disorder.