Kornimate/medical-research-clean huggingface dataset:
characterization of diabetes mellitus in fibrous dysplasia/mccune-albright syndrome

Conditions: McCune-Albright Syndrome; Fibrous Dysplasia; Intraductal Papillary Mucinous Neoplasm; Diabetes Mellitus

Summary: the investigators' objective is to understand the pathogenesis of diabetes mellitus in fibrous dysplasia/mccune-albright syndrome (fd/mas) by: 1) establishing the contributions of insulin resistance versus impaired insulin secretion, 2) investigating presence of excess glucagon signaling by measuring gluconeogenesis and glycogenolysis, and 3) investigating a potential interaction between diabetes and intraductal papillary mucinous neoplasms (ipmns).

specific project aims include: aim 1: determine insulin secretion and sensitivity in subjects with mas-associated diabetes. aim 2: measure gluconeogenesis and glycogenolysis in mas-associated diabetes to investigate a potential role for excess glucagon signaling. aim 3: determine if ipmn development is associated with impairment of insulin secretion prior to development of overt diabetes. the authors expect that this study will: 1. establish the etiology of diabetes in fd/mas 2. increase understanding of the role of ipmns in pathogenesis of diabetes 3. provide critical insights into the pathogenesis of diabetes in fd/mas

Eligibility criteria:
inclusion criteria: fibrous dysplasia/mccune-albright syndrome (fd/mas) group: * must be diagnosed based on clinical grounds and/or mutation testing on bone and/or affected tissue control group: * must be at least 18 years old exclusion criteria: fibrous dysplasia/mccune-albright syndrome (fd/mas) group: * unwilling to fully cooperate with the evaluation * unable to provide informed consent control group: * history of diabetes, insulin resistance, pancreatic disease, pancreatic cysts or amylase/lipase abnormality * use of any type of oral diabetes medications and/or insulin * unable to provide informed consent
adherence in clinical trials-induction strategies

Conditions: Cardiovascular Diseases

Summary: to examine the effects of two strategies of inducing enhanced adherence to medication in the context of a clinical trial: habit training versus habit training plus problem solving.

background: the success of any therapeutic intervention, whether preventive or curative, is ultimately dependent on the individual's adherence to treatment. unfortunately, the failure of a large percentage of patients to adhere to prescribed medical regimens is a widely recognized and well documented phenomenon. it has been estimated that as many as 50 percent of patients do not take their prescribed medications, and of those remaining, less than two-thirds take their medication as prescribed. the interventions, implemented at the outset of pharmacologic intervention within the clinical trial, were timed to yield maximum effectiveness. such randomized induction studies had not yet been undertaken. by capitalizing on a new unobtrusive assessment technique that generated the time of medication intake over prolonged periods, the study produced a unique set of data suitable for the study of recurring cycles in medication intake patterns. the study was part of a two grant initiative entitled "evaluation of adherence interventions in clinical trials". the initiative was developed by the behavioral medicine branch staff and clinical trials branch staff as well as members of the clinical applications and prevention advisory committee behavioral medicine and prevention working groups. the initiative was released in september, 1991 and awarded in september, 1992. design narrative: randomized, double-blind, two-group design. within each of the groups, half of the subjects were on lovastatin and half on placebo. the main outcome measure was medication intake monitored daily and unobtrusively with the mems electronic monitor. for each subject, event time series of six months duration were obtained. the effect of these interventions were determined on average adherence at two and six months; and variability of adherence. in addition, the relative cost effectiveness of each intervention was examined by a recalculation of sample size needs based upon increased adherence and related cholesterol lowering. ancillary goals of the study included: determining the components of variability of medication intake using statistical modeling techniques; and covariates of treatment effects, including baseline daily hassles, problem solving skills, and generalized expectancy for success. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
engaging tribal policy makers to improve the food and physical activity environments in american indian communities

Conditions: Obesity

Summary: the overall objective of the study is to reduce adult obesity in participating american indian (ai) communities and to improve understanding of the behavioral and environmental factors affecting obesity in these settings.

the investigators plan to accomplish this objective by developing, implementing, and evaluating a randomized controlled trial of an intervention to improve diet and physical activity-related risk factors of obesity. a previous iteration of the intervention trial, called obesity prevention research and evaluation of intervention effectiveness in native north americans (oprevent) was implemented in five american indian communities in michigan and new mexico. oprevent was a multi-level, multi-component intervention functioning at the community, institution, household, and individual levels and was implemented in schools, food stores, and worksites. prior to oprevent, the research team has run multi-level interventions by working with schools and food stores in native north american (nna) communities1-6. for this new trial, named oprevent2, the research team will expand on the collective experience working on obesity prevention interventions in american indian (ai) settings by developing complementary policy and social media components to support long-term sustainability of the oprevent intervention. oprevent2 will be implemented in six new ai communities.

Eligibility criteria:
inclusion criteria: * with the exception of the school intervention, which will only include teachers of grades 2-6 and students in grades 2-6 (ages 6-13), all community members will be included in the intervention. gender, age and locale * the investigators will work with male and female schoolchildren and adults, aged 6-13 and 18-75 years who live in one of the participating tribal communities. exclusion criteria: * no adult community members will be excluded from the intervention as they are "passive" media and environmental changes, and available to everyone.

Keywords: native american obesity multi level policy schools worksite social media food store
options: a patient-centered hiv prevention decision aid for prep uptake for women with substance use in treatment settings

Conditions: HIV Infections; Substance Abuse

Summary: to develop and test the effect of a patient-centered hiv prevention decision aid on hiv pre-exposure prophylaxis (prep) uptake among women with substance use disorders (sud) in treatment.

to test the effect of the informed decision aid intervention on prep uptake among women with substance use disorders in treatment. investigators hypothesize that compared to those receiving standard harm reduction information, women receiving the decision aid will have a significant increase in prep uptake at 6 and 12 months post-intervention.

Eligibility criteria:
inclusion criteria: * self- identification as female (i.e., cis- or trans- women), age ≥18, hiv negative status (confirmed with apt date from rapid testing procedures), and entering or receiving treatment at our partnering site, the apt foundation, inc. (a drug treatment center). exclusion criteria: * women on prep at baseline, unable or unwilling to provide informed consent, threatening to staff, pregnant, or experiencing symptoms of physiological withdrawal that interfere with ability to provide informed consent
objective diagnosis method and efficacy of repetitive transcranial magnetic stimulation as a treatment for tinnitus

Conditions: Tinnitus

Summary: investigation of objective tinnitus diagnosis method through measurement of continuous resting eeg, auditory erp before and after repetitive transcranial magnetic stimulation (rtms) treatment of tinnitus.

tinnitus is defined as the subjective perception of a sound in the absence of any physical sound. therefore, accurate diagnosis of tinnitus is so difficult. so, investigators measure auditory erp through autonomously developed system to make a objective diagnosis tinnitus. moreover, patients undergo continuous resting eeg measurement. in this study investigators examined the efficacy of rtms treatment for tinnitus and check into changes in brain connectivity or auditory task with erp, continuous resting eeg before and after rtms. and develop a new test that can detect tinnitus objectively in humans, using the prepulse gap paradigm

Eligibility criteria:
inclusion criteria: * diagnosis of chronic tinnitus * chronic subjective tinnitus for more than 6 months * subject is naive regarding rtms * other concurrent treatments: a four-week washout from any other tinnitus treatment or management program is required prior to entering this study * stable enough to complete this study per the opinion of the study physician * no restrictions, provided the dosages have been in place for at least 3 months * a three month washout from any other tinnitus treatment or management program is required prior to entering this study. exclusion criteria: * objective tinnitus or tinnitus with treatable cause * presence of intracranial or intraocular ferromagnetic materiel or particles * cardiac pacemaker or other electronic implants (including cochlear implant) serious heart disease or other unstable major medical condition * personal history of central nervous system disorder, head injury, stroke or seizures * familial history of epilepsy * concomitant medication with antidepressants and antipsychotics * pregnant women * others known contraindications to rtms or brain mri

Keywords: tinnitus eeg erp
celecoxib as a post-tonsillectomy pain medication

Conditions: Tonsillitis

Summary: the hypothesis is that celecoxib effectively reduces pain after a tonsillectomy and reduces post-operative narcotic use. to test this hypothesis, the study is placebo controlled (sugar pill). half of the participants will receive a sugar pill, half will not. all participants will receive the standard post-operative pain medications. we ask participants to log the amount of medications they use daily, and the amount of pain they have each day. it is hoped that celecoxib will reduce the amount of post-operative pain medication needed.

post-tonsillectomy pain is typically controlled through narcotic medications, such as lortab elixir. despite its standard use, this pain control is typically not as effective as a non-steroidal anti-inflammatory medication (nsaid). the problem with using nsaids for post-tonsillectomy operative pain is the significant increased risk of rebleeding. celecoxib is an nsaid that is a cox-2 inhibitor; the drug is designed to act as an nsaid without the increased risk of rebleeding or hemorrhage. this study is a double blind, randomized study; neither the study participant or the study investigator knows if the participant is receiving celecoxib or a placebo (sugar pill). the blinded list is maintained by the research pharmacists and can be unblinded when needed (such as in an emergency). participants begin taking the study medication the night before surgery and continue through 10 days post-operative. participants are asked to complete a journal that catalogs the amount of standard post-operative medications taken, the amount of pain experienced, and any other comments. participants are contacted by phone at 5 and 10 days post-op. study participation ends at the standard 3-week post-operative check-up.

Eligibility criteria:
inclusion criteria: * age at least 18 years * indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included) * have the ability to understand and the willingness to sign a written informed consent document exclusion criteria: * history of bleeding disorders * history of liver or kidney dysfunction * history of allergy to sulfa containing medications * history of lactose intolerance * history of asthma, urticaria, or allergic-type reactions to aspirin or nsaids * women who are currently pregnant, nursing, or trying to conceive * history of allergy or intolerance to acetaminophen or hydrocodone * history of allergy to any cox-2 inhibitor, including celecoxib or rofecoxib. * pt, ptt, hemoglobin, or hematocrit values that are outside of institutional limits. * history of cardiovascular disease * patients currently taking celecoxib

Keywords: tonsillectomy analgesia pain measurement celecoxib
prospective study of different biological tests (multiplate, rotem) in a cohort of patients followed for essential thrombocytemia (et)

Conditions: Thrombocythemia Essential

Summary: there is no prospective study published on the essential thrombocythemia and the correlation between this specific disease, its complications and the biological variations observed. the aim of this study is to demonstrate a correlation between biological tests of haemostasis, as multiplate analyser and thromboelastometry (rotem) and the occurrence of clinical complications, thrombosis and/or haemorrhage, in order to determine if this biological tests could be biological prognostic factors


Eligibility criteria:
inclusion criteria: * adult aged more than 18 years old * patient followed in consultation for an essential thrombocythemia at diagnosis or during the follow-up * collection of the informed consent * patient affiliated to social security exclusion criteria: * patients aged less than 18 years old * refusal of signature of the informed consent * patients under guardianship

Keywords: essential thrombocythemia multiplate rotem haemorrhage thrombosis vasodilatator stimulated phosphoprotein (vasp)
computer-assisted stop-smoking program in helping doctors counsel patients who smoke cigarettes

Conditions: Tobacco Use Disorder

Summary: rationale: a computer-assisted stop-smoking program may help doctors counsel patients who smoke and may help increase the number of patients who stop smoking. purpose: this phase ii trial is studying how well a computer-assisted stop-smoking program works in helping doctors counsel patients who smoke cigarettes.

objectives: * test the hypothesis that the clinical decision support system will improve the rate at which physicians assist their patients with smoking cessation by providing information and recommendations on smoking cessation resources. * assess whether exposure to information and recommendations facilitated by the smoking cessation-personal digital assistant (sc-pda) will increase the rate at which patients make at least 1 attempt to quit smoking in the month following the physician visit. * assess whether exposure to information and recommendations facilitated by the sc-pda will increase the reported use of counseling and pharmacotherapy during those attempts over that observed with a smoking status identification system alone. * evaluate the acceptance of the sc-pda into the workflow of ambulatory care clinics. outline: in weeks 1-12, physicians have access to a smoking status identification system (ssid) that reminds the physician the smoking status of the patient they are evaluating. in weeks 6-12, physicians have access to a computerized smoking cessation clinical decision support system using a hand-held personal digital assistant (sc-pda) that they can use in the exam room with their patients who smoke. the sc-pda system assists physicians in recommending and prescribing approved pharmacotherapy; facilitates referral of patients to local counseling resources; prints a tailored handout for a patient listing specific recommendations, instructions, and cessation resources; and generates the necessary documentation to support billing for this intervention. patients who visit their physician in weeks 2-6 or weeks 8-12 complete a survey after their clinic visit and undergo a telephone interview 1 month later. physicians undergo interviews and focus groups are conducted with clinic staff in weeks 12-16.

Eligibility criteria:
disease characteristics: * current smoker, defined as self-reported smoking most days or every day (patient) * seeks care at a participating fletcher allen health care primary care clinic (patient) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: tobacco use disorder
impact of covid-19 infection during pregnancy

Conditions: Covid-19 in Pregnancy

Summary: to asses impact of the covid-19 infection during pregnancy on maternal and fetal outcome in relation to gestational age.

covid-19, caused by sars-cov-2, was first reported in the city of wuhan, hubei province, china, at the end of december 2019. the exact origin of human infection has not yet been clearly identified.sars-cov-2 is a member of the coronavirus family, and other pathogens from this family have inflicted a range of viral infections, including middle east respiratory syndrome (mers) and severe acute respiratory syndrome (sars). the incubation period varies from 2 days to 2 weeks following exposure to the virus.the global pandemic caused by the severe acute respiratory syndrome coronavirus (sars-cov-2) has been growing at an accelerating rate. the increasing mortality rate warrants identification and protection of the vulnerable populations in society.it is well known that pregnancy-related immune suppression makes mothers more vulnerable than non-pregnant women to several viral infections, including sars-cov, hepatitis e virus, influenza, and herpes simplex virus. furthermore, changes in pulmonary function during pregnancy, including decreased total lung capacity and functional residual capacity, may cause susceptibility to viral pneumonia. data on clinical outcomes of pregnant women suffering from covid-19 are therefore relatively scarce. recently a meta-analysis of 13 publications reported preterm births, neonatal pneumonia, and respiratory distress syndrome in infants born of covid-19-positive mothers. the rates of cesarean deliveries and adverse pregnancy outcomes were substantially higher

Eligibility criteria:
inclusion criteria: -all medical records of the pregnant women admitted to el bagour quarantine hospital, menoufia governorate due to sars-cov-2 infection, as confirmed by real-time reverse transcriptase-polymerase chain reaction (rt-pcr) assay of nasopharyngeal swab specimens. exclusion criteria: * patients who had equivocal or negative testing results were excluded from the study
pet/mr assessment of sipuleucel t treatment for metastatic castration resistant prostate cancer

Conditions: Prostate Cancer

Summary: this study intents to provide an initial evaluation of the utility of positron emission tomography and magnetic resonance (pet/mr) imaging measures for the prediction of immunological response to sipuleucel t (sipt) therapy.

recent studies of treatments of prostate cancer through stimulation of adaptive immune response have indicated the linear measurements by computed tomography (ct) and nuclear scans used to assess tumor response by response evaluation criteria in solid tumors (recist) were inadequate and the value of progression-free survival (pfs) as a predictive surrogate endpoint of survival was lost. the objective of this study is to provide an initial evaluation of the utility of pet/mr imaging measures for the prediction of immunological response to sipt therapy. investigators expect to identify an"imaging-signature" of response to sipt based on changes in metabolism, perfusion, oxygenation and cellularity of metastasis and its correlation with immunological and clinical response. this approach will help elucidate the mechanism of activity and dynamics of immune antitumor responses to sipt in vivo and to identify new parameters of tumor response and predictive value than current recist and pfs standards.

Eligibility criteria:
inclusion criteria: * men ≥ 18 years of age * history of prostate cancer treated with androgen deprivation * serum testosterone levels \<50 ng/ml * established asymptomatic or minimally symptomatic metastasis * eastern cooperative oncology group (ecog) performance status≤2 * accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent * accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent * patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with zytega or ketoconazole prior to enrollment are eligible * patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone \<2 mg daily or fludrocortisone 0.1 mg daily orally) exclusion criteria: * chemotherapy or radiation therapy treatment within 21 days of sipuleucel-t * ecog performance status \>2 * prior treatment with sipuleucel-t * patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin * patients with known positivity for human immunodeficiency virus (hiv) or hepatitis c; baseline testing for hiv and hepatitis c is not required * patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent * active spinal cord compression.

Keywords: imaging diagnostic castration resistant metastatic prostate cancer immunotherapy