Kornimate/medical-research-clean huggingface dataset:
pistachios blood sugar control, heart and gut health

Conditions: Type 2 Diabetes; Cardiovascular Diseases

Summary: a two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. this study will also investigate how pistachios affects gut health.

a two-period randomized crossover trial will be conducted. participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. during the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. during the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.

Eligibility criteria:
inclusion criteria: * bmi ≥25 and ≤45 kg/m2 * fasting plasma glucose 100 - 125 mg/dl * non-smoking exclusion criteria: * diagnosed diabetes or fasting glucose \>126 mg/dl * systolic blood pressure \>160mmhg or diastolic blood pressure \>100mmhg) * prescribed anti-hypertensive, lipid lowering or glucose lowering drugs * established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions * use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study * women who are pregnant, lactating, planning to become pregnant or have given birth in the past year * weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study * smoking or use of any tobacco products * allergy/intolerance/sensitive to pistachios * consumption of \>14 alcoholic drinks/week * shift-workers and those who cannot consume a snack in the evening
an investigational scan (18f-fluciclovine pet-ct) for the measurement of therapeutic response in patients with metastatic prostate cancer

Conditions: Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8

Summary: this phase iv trial studies how well an investigational scan (18f-fluciclovine pet-ct) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other places in the body (metastatic). 18f-fluciclovine is a radioactive substance that is used in this study with pet-ct imaging scans that may help doctors learn about response to standard therapy in patients with prostate cancer.

primary objective: i. evaluate metabolic response by fluciclovine f18 (18f-fluciclovine) pet qualitatively and semi-quantitatively with standardized uptake values (suv) following androgen deprivation therapy (adt) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (psa) response. secondary objectives: i. to correlate pelvic 18f-fluciclovine pet imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18f-fluciclovine pet imaging sensitivity and specificity for pelvic lymph node cancer involvement. ii. to evaluate 18f-fluciclovine pet imaging response and its correlation with progression free survival (defined by prostate cancer working group 2 \[pcwg2\] criteria). iii. to determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression. iv. to evaluate metabolic response by 18f-fluciclovine pet semi-quantitatively with target to blood pool ratio (tbr) following adt plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and psa response. outline: within 4 weeks before starting standard systemic therapy (sst), patients receive fluciclovine f18 intravenously (iv) then undergo a pet-ct scan over 30 minutes. within 22-28 weeks after starting sst, patients receive fluciclovine f18 iv and undergo a second pet-ct scan over 30 minutes.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven prostate carcinoma * documented evidence of m1 disease by american joint committee on cancer (ajcc) staging by bone scan, ct and magnetic resonance imaging (mri) * castration naive disease, no prior systemic therapy for prostate cancer * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * ability to understand and willingness to sign informed consent exclusion criteria: * known brain metastasis * small cell carcinoma of the prostate
effects of a single dose of egalet® morphine combined with a single dose of alcohol in healthy moderate drinkers

Conditions: Pain

Summary: the purpose of the study is to evaluate the pharmacokinetics of egalet® morphine when administered with alcohol and compare to administration with water.

outcome: pharmacokinetic parameters

Eligibility criteria:
main inclusion criteria: * body mass index (bmi) within the range of 20 to 33 kg/m2 and a minimum weight of at least 50 kg. * current alcohol users who are classified as moderate drinkers * able to abstain from alcohol during the 48 hour period preceding each study visit * free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-lead ecg, and laboratory evaluation main exclusion criteria: * intolerance towards alcohol * history of allergy or hypersensitivity to opioids or related drugs or any excipients * any history of drug or alcohol dependence * clinically significant abnormalities on physical examination, medical history, 12-lead ecg, vital signs, or laboratory values * gastrointestinal disease or constipation or other clinically significant gastrointestinal problems
standard high-dose alpha interferon versus intermittent high-dose alpha interferon

Conditions: Adjuvant; Stage III Malignant Melanoma; Interferon Alpha; Therapy

Summary: the study protocol is being conducted to compare intermittent high-dose i.v. administation of interferon alpha-2b with the standard high-dose treatment by kirkwood with distant metastasis free survival (dmfi) as a primary endpoint.

arm a: interferon-alpha-2b 20 miu/m2 for 4 weeks. 5 days a week i.v followed by 48 weeks of treatment with 3 x 10 miu/m2 s.c arm b: interferon-alpha-2b 20 miu/m2 for 4 weeks. 5 days a week i.v repeated 3 times with 12 treatment-free-weeks between the cycles secondary endpoints: improved overall survival rate, assess side effects of therapy in both treatment arms, assess time spent on sick leave, assess number of treatment-related days in hospital, assess overall performance status, assess blood mx protein levels

Eligibility criteria:
inclusion criteria: * histological documentet cutaneous malognant melanoma * stage iiia, iiib, iiic (ajcc 2002) * r0 resection dating back no longer than 56 days * performance status (ecog o-1) * bone marrow funktion: white cell count \> 3000 cells/ul, platletts \> 100000 cells/ul, hemoglobin \> 10 g/dl * liver and kidney funktion: serum creatinin \< 1.5 times upper limit of normal, ast and alt \< 2.5 times upper limit of normal, serum bilirubin \< 2 times upper limit of normal * written inform consent exclusion criteria: * confirmed distant metastasis * choroid or mucosal melanoma * pregnant or lactating women and women of childbearing potential not using a reliable form of contraception * active autoimmun disease * patients with history of neuropsychiatric disease requiring hospitalization * severe medical condition such us: * florid hepatitis * severe acute infection * myocardial infarction within the past year,symptomatic angina pectoris * grade iii to iv congestive heart failure * serious pulmonary disease * hiv-positive patients with an aids - defining condition * treatment in another clinical drug trial within the last 30 days * a history of hypersensitivity to interferon alfa * history of maignant disease during the past 5 years (except for curatively treated skin carcinoma or in situ carcinoma) * prior high dose interferon alfa therapy.prior adjuvant low dose or intermediate-dose interferon alfa therapy is allowed

Keywords: melanoma,adjuvant therapy,stageiii interferon high dose
sentinel surveillance of malnutrition, niger

Conditions: Malnutrition

Summary: malnutrition is a critical public health problem in developing countries. malnutrition may be linked to more than one half of the deaths in children under 5 years old. in july 2001, after an intervention related to a measles epidemic, medecins sans frontieres-france opened a nutritional program in maradi, in the south of niger. the introduction of ready to use therapeutic foods (rutf), in particular plumpy'nut (nutriset, france) allowed for the treatment of the majority of children at their homes using ambulatory treatment. children with complicated cases were cared for in an inpatient center. with ambulatory treatment the number of children cared for in the msf program reached close to 70000 in 2006. this study aimed to assess the effect of a 3-month distribution of rutf in the context of a preventative supplementary feeding program. the primary hypotheses were that short-term rutf supplementation at the village-level would prevent declines in weight-for-height and reduce the incidence of wasting in children 6 to 60 mo of age over a period of 8 mo. because rutf may have additional health effects, the intervention effect on height-for-age, stunting, mortality and morbidity from malaria, diarrhea, and respiratory infection were also examined.


Eligibility criteria:
inclusion criteria: * all children resident in randomized villages 6-59 months exclusion criteria: * n/a

Keywords: malnutrition ready to use food niger
focused ultrasound for the treatment of neuropathic pain

Conditions: Neuropathic Pain

Summary: a possible treatment approach for neuropathic pain would employ a process designed to promote healthier function of the ventral posteromedial (vpm) and ventral posterolateral (vpl) thalamic nuclei. this study is designed to employ focused ultrasound technology to target the vpm and vpl thalamus among participants with ongoing neuropathic pain syndromes to evaluate for tolerability and early efficacy.

the present open-label study is being undertaken to evaluate focused transcranial ultrasound therapy as an intervention for patients with neuropathic pain. the subjects in this research study will be recruited through medical practice. participants who are enrolled will undergo 8 consecutive weekly ultrasound sessions. targeting for treatment will be based on patient mri scans using stereotaxic techniques.

Eligibility criteria:
inclusion criteria: * history of neuropathic pain (onset, location, intensity, duration, quality, aggravating factors) * confirmation of nervous system injury through imaging or negative or positive sensory signs confined to the corresponding bodily area * failure from at least 3 pharmacological treatments (e.g., antidepressants, anticonvulsants, opioids) * at least 18 years of age exclusion criteria: * subjects unable to give informed consent * subjects who would not be able to lay down without excessive movement in a calm environment * pregnancy, women who may become pregnant or are breastfeeding * subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
study to assess feasibility and safety of iron repletion with feraheme in iron deficient patients with durable ventricular assist device support

Conditions: Anemia

Summary: ferumoxytol injection (feraheme®) is a parenteral form of iron supplementation that is fda-approved for treatment of iron deficiency anemia. ferumoxytol injection achieves iron repletion in fewer doses (2) when compared with other available injectable iron formulations (5-6) available at nyu langone health, and thus may be useful to reduce travel burden and expedite full iron repletion in patients with iron deficiency. iron-deficiency anemia is common in patients after placement of a ventricular assist device (vad) for treatment of end-stage heart disease. this is a pilot study to test the feasibility of iron repletion with ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency after placement of a vad.


Eligibility criteria:
inclusion criteria: * status post placement of durable ventricular assist device with stable clinical status for \>30days * hemoglobin \>6 g/dl and \<13 g/dl (men) or \<12 g/dl (women) within last 90 days * serum ferritin \<100 ng/ml or serum ferritin 100-299 ng/ml with transferrin saturation \<20% within last 90 days * able and willing to provide written informed consent exclusion criteria: * known hypersensitivity to ferumoxytol injection or other intravenous iron preparation * history of anaphylaxis * treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months * renal failure on hemodialysis * respiratory failure on mechanical ventilation * disabling stroke * ventricular assist device thrombosis * evidence of active gastrointestinal bleeding or other active blood loss * hospitalization \<30 days * pregnant or breastfeeding women
a study to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this study is to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with rheumatoid arthritis (ra) assessing real world patient data entered in the corrona ra registry on or after november 2012


Eligibility criteria:
inclusion criteria: * enrolled in the corrona ra registry and initiated tofacitinib on or after november 2012 * initiate tofacitinib (defined as first ever use of tofacitinib) at the corrona enrollment visit or at a corrona follow-up visit from november 2012 onward. * have cdai measured at baseline * have at least a 6-month follow-up visit and cdai measured at the 6-month follow-up visit exclusion criteria: * there are no exclusion criteria for this study
endothelin-1 and cardiac allograft vasculopathy (cav)

Conditions: Cardiac Allograft Vasculopathy

Summary: many patients with end-stage heart failure, a condition in which the heart fails to pump enough blood to support the body's other organs, are fortunate enough to receive a heart transplant. however, despite taking medicines aimed at blunting the immune system's response to the donor heart, some of them will develop transplant-related disease in the coronary arteries supplying their hearts. fifty years after the first human-to-human heart transplant, this disorder-cardiac allograft vasculopathy (cav)-remains a leading cause of long-term death and has been coined the 'achilles' heel' of heart transplantation. indeed, a better understanding of how cav occurs and improved therapies to prevent and/or slow its development are desperately needed to meaningfully impact patient outcomes. endothelin-1 (et-1) is a key molecular regulator of arterial health, and our prior data suggests that it is associated with accelerated cav. in this particular study of recent heart transplant recipients, we are asking: does et-1 contribute to the coronary artery's capacity to dilate/constrict? to answer this question, during the cardiac catheterization at 1 year post-transplant (standard of care), we will measure blood levels of et-1 and perform an invasive evaluation of coronary vasomotor function inn a consecutive subset of patients who will have received a 1-week course of the oral endothelin receptor antagonist (macitentan) prior this catheterization, which will allow us to test how much et-1 contributes to coronary responsiveness. the findings from this study may provide the necessary foundation to study whether endothelin receptor antagonists are able to effectively reduce the rate of accelerated cav.


Eligibility criteria:
inclusion criteria: * 1) new heart transplant recipients already enrolled into a prospective cohort (parent) study * 1a) underwent baseline coronary angiography within the first 4 months of heart transplantation * 1b) have yet to complete 1-year coronary angiogram * 2) ≥18 years old * 3) have a serum creatinine \< 2.0 mg/dl (to minimize risk of contrast-induced nephropathy) * 4) able to provide informed written consent. exclusion criteria: * 1) multi-organ transplant * 2) transplant-related complications and comorbidities that preclude the ability to safely perform an invasive coronary evaluation in the cardiac catheterization laboratory * 3) pregnant women due to possible fetal harm; all women of childbearing potential must have a negative pregnancy test within 1 week of starting macitentan, and 30 days after completing the one-week course of macitentan. * 4) patients who are taking potent cyp3a4 inhibitors (e.g. ketoconazole, ritonavir) as these drugs can expose one to higher levels of macitentan * 5) cirrhosis or baseline liver function tests (ast/alt) \> 3x the upper limit of normal

Keywords: heart transplantation endothelin-1 cardiac allograft vasculopathy
consent for use of stored patient specimens for future testing

Conditions: HIV Infections

Summary: the purpose of this study is to obtain informed consent to use stored human biological materials (hbm) (e.g., blood and other tissues) for future studies that may include genetic testing.

during past, present, and future adult aids clinical trials group (aactg) clinical trials, samples of hbm (e.g., blood, other body fluids and tissues) have been or will be obtained and stored until analyzed, as defined by the particular trial for which the patient provided consent. some hbm may be left over after a trial is completed. important questions may arise during the design of a study; some of these questions may be addressed only with archived (rather than prospectively collected) hbms. to improve understanding of hiv disease and its optimal management, it is critical that hbms be available to investigators for subsequent unspecified analyses. all patients are asked to sign the informed consent form and specify whether or not they agree to allow their leftover samples to be used for secondary analyses and whether or not they agree to have one 14 ml blood sample drawn in this study for dna archiving for use in currently unspecified genetic analyses. only under extraordinary circumstances will any individual patient from whom hbm was obtained be notified of any test result from secondary testing. patients who do not agree to either option will indicate this on the informed consent and will have no further involvement in this study. declining consent does not in any way jeopardize participation in any other current or future actg clinical trial. consent may be obtained at the same time the patient is being enrolled into any actg clinical trial, at some interval after the patient has entered but is still participating in a trial, or at any time after the patient has completed participation in a trial. the goal of this study is to allow archived hbm to be used for research purposes while protecting the identity of patients from whom such samples were obtained. the focus is on obtaining permission to analyze archived hbm in ways not planned at the time the initial informed consent was obtained.

Eligibility criteria:
inclusion criteria: * parent or guardian willing to give informed consent, if applicable * either currently participating in or have ever participated in an aactg clinical trial

Keywords: specimen handling blood informed consent genetic screening
comparing of different visual aids like video,info-graphics and pamphlets in enhancing community awareness and promoting behavioral change towards the prevention of hypertension in basilica of the most holy trinity onitsha anambra state,nigeria

Conditions: Hypertension

Summary: the goal of this observational study is to assess different level of enhanced awareness and behavioral change of adults over the age of 35 who will be educated using video,infographic and pamphlet for the interval of one month


Eligibility criteria:
inclusion criteria: * adults age over 35 years old * who does not know his/her blood pressure status within the last 6 months (the person who does not know he or she has a hypertension or not.) * who agree to participate exclusion criteria: * who cannot come to the church 4 weeks later after the intervention. * known hypertensive patients

Keywords: behavioural change in hypertension prevention
moderate rheumatoid arthritis (ra) with etanercept (enbrel)

Conditions: Rheumatoid Arthritis

Summary: this study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (dmard) therapy in patients with moderately active rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * male or female ≥18 and ≤80 years of age at time of screening * diagnosed with rheumatoid arthritis as determined by meeting 1987 american college of rheumatology (acr) classification criteria and has had rheumatoid arthritis for at least 6 months * moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the c-reactive protein formula (das28-crp) \> 3.2 and ≤ 5.1 * active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (a full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. the 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees) * must be currently taking a dmard such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine exclusion criteria: * prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening * class iv rheumatoid arthritis according to acr revised response criteria * any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose * previously used more than one experimental biologic dmard. patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. the use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product * previously used more than one commercially available biologic dmard. subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. the use of the biologic must not have occurred within 2 months of the first dose of investigational product. acceptable prior use of biologics include the following examples: * no more than 4 injections of adalimumab * no more than 8 (50 mg) injections of etanercept * no more than 2 infusions of infliximab * no more than 2 infusions of abatacept * additional inclusion (exclusion) criteria may apply

Keywords: ra enbrel dmard joint count rheumatoid arthritis etanercept disease modifying anti-rheumatic drug