Kornimate/medical-research-clean huggingface dataset:
vitamin d, glucose control and insulin sensitivity in african-americans

Conditions: Type 2 Diabetes

Summary: north american blacks tend to have low blood levels of vitamin d because pigmentation blocks vitamin d production in the skin. they also have higher rates of developing type 2 diabetes and higher rates of complications from the disease compared with whites. although there is compelling evidence that adequate vitamin d may reduce the risk for type 2 diabetes in whites, recent evidence from a national survey demonstrated an association of vitamin d with diabetes in whites but not in blacks. however, the central hypothesis of this study is that providing enough supplemental vitamin d to blacks (raising their blood levels higher than that of most participants in the survey) will improve blood measures related to diabetes risk. the proposed study is a 12-week randomized, double-blind, placebo-controlled experiment designed to examine the effect of vitamin d supplementation (100 μg/d ) on insulin secretion, insulin sensitivity and glucose control in pre-diabetic black men and women aged 40 and older.


Eligibility criteria:
inclusion criteria: * african-american by self designation * glucose intolerance defined as fpg ≥ 100 mg/dl or a1c ≥ 5.8% * bmi 25.0-39.9 * age 40 or older exclusion criteria: medical conditions * diabetes potentially requiring pharmacotherapy, defined as a1c \> 7% * uncontrolled thyroid disease * current parathyroid, liver or kidney disease * renal stone within 5 years * sarcoidosis, current pancreatitis, active tuberculosis, hemiplegia, gout * inflammatory bowel disease, colostomy, malabsorption * cancer other than basal cell skin cancer within 5 years * uncontrolled arrhythmia in past year * albinism or other condition associated with reduced skin pigmentation * pregnancy over the last 1 year * intent to become pregnant * menopause onset within 1 year * any other unstable medical condition laboratory tests * fasting plasma glucose \< 100 * hemoglobin a1c \> 7% * laboratory evidence of liver disease (e.g. ast \> 70 u/l or alt \> 72 iu/l) * laboratory evidence of kidney disease (e.g. estimated glomerular filtration rate \< 60 ml/min/1.73 m2). * elevated spot urine calcium to creatinine ratio \> 0.38 mg/dl\* * abnormal serum calcium (serum calcium \> 10.5 mg/dl) * anemia (hematocrit \< 36% in men, \<33% in women) medications (use in past three months) * estrogen or testosterone * prescription vitamin d * lithium * oral corticosteroids * anti-seizure medications * unstable doses of psychotropics or phenothiazines * cholestyramine supplements (current use - may discontinue after screening) * vitamin d supplements, cod liver oil, calcium supplements other * body mass index less \ 39.9 * consumption of more than 14 alcoholic drinks per week * inability to attend all three study visits as scheduled * inability to provide written informed consent * age \< 40 years * not african-american (by self-designation) * participation in another research intervention study * corresponds to a 24-hour urinary calcium excretion \> 400 mg

Keywords: diabetes vitamin d african americans overweight insulin sensitivity glucose control
highly suppressive treg in delayed and slow graft function after kidney transplantation

Conditions: DGF; Kidney Transplant; Complications

Summary: delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. the increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. there are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. regulatory t cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. we hypothesize that the pre-transplant measurement of highly suppressive regulatory t cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. ultimately, marginal kidney graft allocation could be directed to regulatory t cell-robust recipients and regulatory t cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.


Eligibility criteria:
inclusion criteria: - adult kidney transplant candidates immediately prior to their kidney transplant surgery exclusion criteria: * \< 18 years old * active immunosuppressive drug use * hepatitis c * hiv

Keywords: dgf sgf acute rejection kidney transplantation
the importance of adrenomedullin (am) on acth-cortisol-glucose axis

Conditions: Systemic Inflammatory Response Syndrome; Hyperglycemia

Summary: hyperglycemia is frequent manifestations of the human metabolic response to systemic inflammatory response syndrome (sirs),sepsis and septic shock, and are implicated in the clinical outcome. adrenomedullin is elevated in sirs, sepsis and septic shock and has been demonstrated the inhibitory role on insulin and adrenocorticotropic hormone secretion. our hypothesis is that: am elevation after sirs could be the responsible to maintain hyperglycemia

studies in cultured vascular endothelial cells and vascular smooth muscle cells demonstrate that cytokines strongly stimulate adrenomedullin production and release. adrenomedullin has been measured in a wide range of clinical researches. of all conditions investigated, the greatest increment in plasma adrenomedullin has been observed in septic shock. it appears that am is directly responsible for the hypotension characteristic of septic shock. studies have shown that administration of am and ambp-1 before the onset of sepsis (i.e., pretreatment) prevents transition from the hyperdynamic phase to the hypodynamic phase in the progression of sepsis, attenuates tissue and organ damage, and reduces sepsis-induced mortality. two groups described the effects of am on the pituitary. taken together, these studies suggest that am has a role in inhibiting acth release. mulder et al. first reported the stimulatory effects of adrenomedullin on insulin secretion from isolated rat islets. in direct contrast to this, martínez et al. clearly demonstrated the inhibitory role of adrenomedullin on insulin secretion in vitro.

Eligibility criteria:
inclusion criteria: * children above 2 years, submitted to elective cardiopulmonary bypass (cpb, only interatrial or ventricular communication) with no endocrine disease or infection. exclusion criteria: * children with endocrine disease, undernutrition, with some medication that might interfere in the study (corticosteroids.

Keywords: adrenomedullin glucose insulin systemic inflammatory response syndrome pediatric cortisol acth
safety and tolerability of multiple inhaled nva237 doses in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of the nva237 in mild and moderate copd patients .


Eligibility criteria:
inclusion criteria: * male and/or female patients aged from 40-75 years of age with mild to moderate copd. * diagnosis of mild/moderate copd, according to the gold guidelines. * bronchodilatory response to ipratropium at screening * current or ex-smokers with a smoking history of \>10 pack-years. ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc. * female patients must have been surgically sterilized at least 6 months prior to screening or: postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion. * lab and post-bronchodilator values within a certain range. * body mass index (bmi) must be within the range of 18 to 32 kg/m2. exclusion criteria: * any significant medical condition that in the opinion of the investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial. * any medical condition that may make spirometry unsafe * history of glaucoma, symptomatic prostatism or urinary retention. * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations and for any other limitation of participation based on local regulations. previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study. * donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation. * significant illness (other than respiratory illness) within the two weeks prior to dosing. * clinically significant ecg abnormalities indicative of an unstable underlying cardiac problem, e.g. recent myocardial infarction, 2nd/3rd degree heart block, or a family history grandparents, parents and siblings of a prolonged qt-interval syndrome. * history of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug or drugs similar to the study drug. * history of immunocompromise, including a positive hiv (elisa and western blot) test result. * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * history of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations. * patients who are unable to demonstrate appropriate use of the concept 1 device at screening other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple inhaled, nva237, copd
association of carbamylated hdl and cad in t2dm patients

Conditions: Type 2 Diabetes Mellitus With Circulatory Complciation

Summary: this is an observational cross-sectional study aimed at investigating the alterations of the carbamylated-hdl levels in t2dm patients, and comparing the concentration of carbamylated-hdl between the t2dm patients with cad and without cad to explore the association between carbamylated-hdl and risk of cad in t2dm patients.

high-density lipoprotein (hdl) is involved in various atheroprotective processes, including reverse cholesterol transport, inhibition of lipid oxidation and inflammatory cytokine secretion, endothelial repair, and antiapoptotic function, which all contribute to the regression of plague burden. recent studies have shown that oxidative stress and chronic inflammation - both implicated in the process of diabetes - can contribute to an irreversible post-translational modification called carbamylation. carbamylation levels reflect the burden of enhanced inflammation, oxidative stress, and renal impairment, and can serve as a biomarker of certain pathological conditions. several clinical studies have demonstrated positive associations between cardiovascular risk, mortality, and serum carbamylation-derived product levels in the general population and particularly in patients with kidney failure. increasing evidence also shows that carbamylated lipoprotein plays a pivotal role in atherosclerosis.18 however, most studies concerning carbamylation have been performed under a kidney disease background. whether hdl particles in patients with type 2 diabetes mellitus (t2dm) show enhanced carbamylation and whether this enhancement is associated with vascular complications remains unknown. thus, in the present study, the investigators aim to test whether hdl experiences carbamylation in t2dm patients and investigated the pro-atherogenic effects of carbamylated hdl on endothelial-monocyte adhesion.

Eligibility criteria:
inclusion criteria: 1:clinical diagnosis of t2dm (according to the criteria of the american diabetes association.) exclusion criteria: 1. end-stage renal disease (esrd) 2. acute coronary syndrome, 3. heart failure, 4. chronic viral or bacterial infection, 5. cancer, 6. immune system disorders

Keywords: carbamylation,hdl,t2dm
swallowing rehabilitation in patients with head and neck cancer receiving radiotherapy

Conditions: Cancer of Head and Neck

Summary: head and neck cancer has a negative impact in swallowing function and quality of life. rehabilitation has proven its usefulness after radiation therapy (rt), but some studies suggest that interventions should be initiated prior to rt sessions. this study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. the study pretends to establish a preventive rehabilitative program with the target of reducing rt side effects and improve patients' quality of life.

head and neck cancer has a negative impact in swallowing function and quality of life. although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients. some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (rt), regardless the need of concomitant chemotherapy (rt-qt). other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction. patients receiving rt or rt-qt refer worsening of their quality of life, especially during the first days after treatment. one study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. however, this observation should be contrasted with a randomized study.

Eligibility criteria:
inclusion criteria: * patients with advanced head and neck cancer receiving radiotherapy exclusion criteria: * candidates to surgical treatment * previous head and neck cancer * dysphagia due to causes other than cancer * previous head or neck radiation therapy.

Keywords: head and neck cancer dysphagia rehabilitation radiation therapy
implementation of the golden hour for preterm infants : a quality improvement study

Conditions: Premature Birth

Summary: effective initial stabilization of preterm neonates in the initial 60 minutes of life ("golden hour") was shown to improve outcomes. keys components include anticipative and collaborative approach, respiratory support, thermal regulation and early initiation of parenteral nutrition. the objective is to complete the admission within 60 minutes of delivery.


Eligibility criteria:
inclusion criteria: * premature infants (\< 31 weeks' gestation) * infants with expected weight less than 1300 g * inborn babies exclusion criteria: * infants outborn * infants with major congenital anomalies (laparoschisis, omphalocèle, diaphragmatic hernia, ...) * parental refusal

Keywords: premature birth golden hour 60 minutes
change in oxygen consumption following inhalation beta agonists in healthy adults

Conditions: Oxygen Consumption

Summary: albuterol is the most commonly used β agonist to treat reversible lower airway obstruction. albuterol contains a racemic mixture of two enantiomers. levalbuterol contains the single r form enantiomer. levalbuterol is frequently prescribed to limit cardiovascular toxicity. the investigators sought to examine the changes in oxygen consumption (v'o2) and heart rate (hr) following administration of albuterol and

inhaled β2 adrenoceptor agonists are frequently used to treat reversible lower airway obstruction, or to assist with mucociliary clearance. albuterol remains the most commonly used β agonist and contains a racemic mixture of two enantiomers. the r enantiomer is the active moiety responsible for the bronchodilation, while the s enantiomer was initially thought to be inactive, although recent studies suggest otherwise. levalbuterol contains the single r form enantiomer, and in clinical practice it is frequently prescribed not only because of its bronchodilator benefits, but to limit cardiovascular toxicity. adverse cardiovascular effects remain the main dose-limiting factor for β2 agonists. the primary objective of the investigators study is to compare the change in oxygen consumption following albuterol to that of levalbuterol, in healthy adult volunteers. the investigators hypothesized there would be no clinically significant difference in v'o2 between the two drugs, if equal doses of the r-enantiomer were administered. secondary objectives were to compare the changes in heart rate and other vital signs between the two drugs.

Eligibility criteria:
inclusion criteria: * healthy volunteers between the ages of 18 and 60 years exclusion criteria: * coronary artery disease, history of intolerance to beta agonists

Keywords: beta agonists asthma albuterol levalbuterol
dexamethasone and post-tonsillectomy pain in children

Conditions: Pediatric Post-tonsillectomy Pain

Summary: the investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims: * specific aim 1: to evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (ptp) in children * specific aim 2: to prospectively evaluate differences in early ptp experience between overweight/obese children and their lean peers. * specific aim 3: to determine whether circulating inflammatory markers are strongly linked to ptp severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following tonsillectomy and or adenoidectomy.

(see brief summary as well) the study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research if the investigators find that bmi-dependent disparity exists in post tonsillectomy pain (ptp) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces ptp, our findings should ultimately lead to improved postoperative pain management of pediatric ptp especially in obese children.

Eligibility criteria:
inclusion criteria: * scheduled for tonsillectomy and/or adenoidectomy at university of michigan, c. s. mott children's hospital exclusion criteria: * known hypersensitivity to dexamethasone * developmental delay * taking chronic analgesics * taking chronic systemic steroids * treatment with steroids in last 30 days * cushings or prader-willi or nephrotic syndromes * diabetes mellitus
lifestyle intervention and metformin for women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to determine if the combination therapy of lifestyle intervention and use of metformin together will improve ovulation induction and hyperandrogenemia in women with polycystic ovary syndrome, by gathering data from adult and adolescent females.

pcos is characterized by excess circulating androgen levels and chronic anovulation. pcos is also characterized by insulin resistance and hyperinsulinemia. several recent studies in a variety of non-hospital based populations have provided evidence that the incidence of hyperandrogenic chronic anovulation is in the range of 4-6% of the female population. improvements in insulin sensitivity in women with pcos, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in pcos. the primary objective in the adult female population is to determine that combination therapy will improve ovulatory frequency. secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then single agent therapy. the primary objective of the adolescent population is to determine that the combination therapy will improve hyperandrogenemia. secondary objective is to improve ovulatory frequency and insulin sensitivity than just the use of a single agent therapy.

Eligibility criteria:
inclusion criteria: * spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year * elevated testosterone levels * general good health * off of current medications which may confound response to study medications exclusion criteria: * pregnancy * lactose intolerance * medical contraindications * elevated prolactin, 17hydroxyprogesterone, or follicle stimulating hormone blood tests * diabetes, liver, heart, kidney or uncorrected thyroid disease

Keywords: polycystic ovary syndrome (pcos) anovulation elevated testosterone
community pharmacy-based prescription drug monitoring program opioid risk assessment tool

Conditions: Opioid Abuse; Prescription Opioid Abuse

Summary: this goal of this observational study is to develop and test the opioid risk reduction clinical decision support (orrcds) tool. the tool will be an opioid medication risk screener and decision support platform that will be used by pharmacists upon dispensing prescription opioid medication. once the opioid risk reduction has been developed, we will examine the impact of the orrcds within two divisions of a large chain retail pharmacy. pharmacies will be randomized to using the opioid risk reduction clinical decision support (orrcds) tool or standard of care opioid dispensation. we hypothesize that patients at pharmacies randomized to the orrcds tool will be more likely to reduce their risk status to low or moderate compared to the patients at standard of care pharmacies.

in our previous research, patients have reported a willingness to answer questions and discuss opioid medication use with pharmacists in these settings. therefore, community pharmacy settings are an underused resource with great promise for screening and engaging patients to reduce opioid medication misuse. currently, prescription drug monitoring programs (pdmp) are the most available tool to pharmacists for monitoring opioid use among patients. as a result, pdmp users must rely on their "best judgment" in clinical decision-making and often provide patient care and referrals with a limited evidence base. the question of highest importance in the field of prescription medication misuse is: how can pdmp information/output be most usefully utilized for patient intervention within an evidence-based opioid risk reduction clinical decision support (orrcds) tool. this study will develop and test the opioid risk reduction clinical decision support (orrcds) tool and examining facilitators and barriers to sustainability and broader dissemination. the study is organized into 3 aims: aim 1: orrcds tool development which will include a universal opioid medication risk screener and decision support platform. aim 2: once the orrcds has been developed, we will conduct a type-1 cluster 2-arm randomized trial to examine the impact of the orrcds tool within two divisions of a large chain retail pharmacy. we hypothesize that patients with moderate or high opioid risk will be more likely to reduce risk status to low or moderate following orrcds implementation compared to standard care. aim 3: following the completion of the cluster randomized trial, qualitative interviews will be conducted with pharmacists and leaders from a large chain retail pharmacy and pdmp vendor about the potential barriers and facilitators to the sustainability (continued use at the stores in this project) and broader dissemination (implementation at other stores outside of those in this project) of the orrcds.

Eligibility criteria:
inclusion criteria: * a large chain retail pharmacy chain in the cincinnati or columbus, ohio area exclusion criteria: * none this study does not involve individual patients as randomization will occur among pharmacies.