Kornimate/medical-research-clean huggingface dataset:
improving outcomes for emergency department patients with alcohol problems

Conditions: Drinking, Alcohol

Summary: the investigators will conduct a study to examine the impact of an alcohol peer-mentor intervention starting in the emergency department (ed) combined with 6 peer booster sessions to reduce hazardous drinking and facilitate primary/specialty care use compared to enhanced usual care. approximately 450 veterans with hazardous drinking behaviors will be randomized to one of these two conditions. follow-up assessments will occur at 3-, 6-, and 12-month post-randomization.

the objective of the study is to conduct a randomized controlled trial to determine the efficacy of an alcohol peer-mentor intervention starting in the ed, combined with a continuing 6-session program of post-ed strengths-based peer mentorship to facilitate reduction in hazardous drinking, and linkage and engagement in primary and/or specialty alcohol treatment services and mental health care, if needed. project methods: the study will screen veterans affairs (va) ed patients for hazardous drinking. those screening positive and who enroll in the study will be randomized to one of two conditions: 1) alcohol peer-mentor (apm) intervention (n=225), or 2) brief advice (ba) comparison condition (n=225). stratified random assignment to conditions will be by sex and presence of aud (yes/no) defined as a score of 14 for men and 10 for women on the audit. randomization will proceed in blocks of 10. all participants will also receive written community resource information. participants randomized to the apm condition will receive peer support to reduce hazardous drinking, and those who meet alcohol use disorder criteria will be coached by the peer and will assist in a warm handoff linkage to addiction treatment.

Eligibility criteria:
inclusion criteria: screening: * presenting for care in the ann arbor veterans health administration (vha) ed * medically stable * able to provide informed consent enrollment: * have an audit-c score of 4 or more for men and 3 or more for women in the prior 3 months, indicating that they meet criteria for hazardous use (niaaa 2005; world health organization) * have a telephone and/or the ability to provide information about individuals who can help contact the participant exclusion criteria: screening: * do not understand english * patients in or having received substance abuse treatment in the past 3-months, per medical record * patients in or having received peer services in the past 3-months, per medical record * pregnant women * patients deemed unable to provide informed consent * profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments enrollment: * patients currently active in or having received alcohol or other substance abuse treatment in the past 3-months, per self-report screening. * patients currently active in or having received peer services in the past 3-months, per self-report screening.

Keywords: veterans health intervention, brief peer
impact of obesity on the efficacy of endocrine therapy with aromatase inhibitors

Conditions: Breast Cancer

Summary: to see the impact of obesity on the efficacy of adjuvant endocrine therapy with aromatase inhibitors in postmenopausal patients with early breast cancer in terms of: i) locoregional recurrence ii) distant metastases iii) disease-free survival iv) overall survival

the relationship between obesity and breast cancer is a complex one. obesity is a risk factor for the development of breast cancer in postmenopausal women and has been linked to an increased risk of recurrence and decreased survival as compared to patients with normal weight. the hypothesis that led to this study is that the amount of total-body aromatization capacity indicated by body mass index (bmi). in postmenopausal women and in premenopausal women with ovarian suppression, the major source of serum estrogens is the fat tissue, in which precursors are metabolized to estrogens by the enzyme aromatase. thus, an increase in bmi leads to an increase in total-body aromatization and, consequently, an increase in oestrogen serum levels, which impact on breast cancer. taken together, this suggests that bmi may serve as a useful surrogate parameter for total-body aromatization and eventually may be a practicable tool to tailor aromatase inhibitors (ais) therapy for individual patients. the study will include 360, postmenopausal patients with early breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (er) and/or progesterone receptor (pr). patients will be randomly assigned to receive tamoxifen 20 mg once daily or ais (letrozole 2.5mg/ anastrozole 1mg/exemestane 25mg) once daily for five years. patients with a tumour stage ib, ic, or ii irrespective of nodal stage (\<10 positive nodes) will be included. weight and height will be taken at baseline for calculation of bmi according to the who criteria. the frequency of adverse events will be used to assess safety throughout the study. the primary end point will be disease-free survival (dfs). secondary end points will be recurrence-free survival and overall survival (os). the data will be analyzed for dfs and os according to the bmi subgroups as well as two treatment arms (tamoxifen v ais). the frequency of adverse events will be used to assess safety throughout the study.

Eligibility criteria:
inclusion criteria: * postmenopausal patients with breast cancer who have hormones receptor positive tumour as defined by the expression of oestrogen receptor (er) and/or progesterone receptor (pr). * patients with a tumour stage ib, ic, or ii irrespective of nodal stage (\< 10 positive nodes) exclusion criteria: * premenopausal patients, * er/pr negative

Keywords: breast cancer obesity aromatase inhibitors postmenopausal
a study to evaluate the pharmacokinetic profiles of cigarettes and e-cigarettes with nicotine salt formulations

Conditions: Healthy Volunteers

Summary: this study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. it was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy us adult smokers.


Eligibility criteria:
inclusion criteria: * having smoked ≥10 manufactured cigarettes per day for at least the last year * expired carbon monoxide level of \>10 ppm at screening * tested positive for urinary cotinine (≥500 ng/ml) exclusion criteria: * known or suspected hypersensitivity to any component of the e-liquid formulations * taking or receiving prescription smoking cessation medicines * willing or considering to stop smoking * smokers who draw smoke into their mouth and throat but do not inhale * relevant illness history * body mass index (bmi) of less than 18 kg/m2 or greater than 40 kg/m2 * breastfeeding women * women of child-bearing potential who were not using an accepted method of contraception
bioequivalence study between two oral formulations of ibuprofen 800 mg tablets under fed conditions

Conditions: Bioequivalency

Summary: compare the rate and extent of absorption of two oral formulations of ibuprofen 800 mg tablets, administered as a 1 x 800 mg tablet, under fed conditions.


Eligibility criteria:
inclusion criteria: * healthy men or women, 18 years of age or older * body mass index between 19 and 30 * willing to participate and sign a copy of the informed consent form exclusion criteria: * history of allergy or hypersensitivity to ibuprofen * recent history of drug or alcohol addiction or abuse * pregnant or lactating women * use of tobacco products during the past 3 months * evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant * receipt of any drugs as part of a research study within 30 days prior to study dosing

Keywords: bioequivalency ibuprofen
pre-op use of incentive spirometry in obese patients

Conditions: Lung Function; Bariatric Surgery

Summary: the purpose of this study is to evaluate the use of preoperative incentive spirometry (is) as an aid to improve postoperative lung function. the hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. the investigators propose to compare a patient population that uses is as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses is with a standardized regimen for at least 3 days prior to the operation in terms of preoperative is volumes, intraoperative pulmonary mechanics, postoperative is volumes, and incidence of postoperative pulmonary complications.


Eligibility criteria:
inclusion criteria: * morbid obesity * bariatric surgery * must be able to use incentive spirometer exclusion criteria: * bmi=\<40 kg/m2 * current symptoms of obstructive sleep apnea or actively using continuous positive airway pressure

Keywords: incentive spirometry bariatric surgery obesity
a phase i/ii study of active immunotherapy with cancer stem cells vaccine for colorectal cancer

Conditions: Neoplasms,Colorectal

Summary: most studies of cancer stem cells (csc) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of cscs. in this study, the investigators examined the vaccination effects produced by csc-enriched populations from histologically distinct murine tumors after their inoculation into different syngeneic immunocompetent hosts. enriched cscs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.immune sera from csc-vaccinated hosts contained high levels of igg which bound to cscs, resulting in csc lysis in the presence of complement.ctls generated from peripheral blood mononuclear cells or splenocytes harvested from csc-vaccinated hosts were capable of killing cscs in vitro. mechanistic investigations established that csc-primed antibodies and t cells were capable of selective targeting cscs and conferring anti-tumor immunity.

to assess the feasibility of generating csc-loaded dc vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with colorectal cancer. the investigators will purify t, b cells and generate dcs from the pbmcs of the colorectal cancer patient.on the other hand, investigators will isolate aldhhigh and aldhlow tumor cells from the tumor specimen of the colorectal cancer patient using a similar protocol as investigators reported . aim 1: to demonstrate, in vitro, the relative cellular anti-colorectal cancer csc immunity induced by colorectal cancer csc-dc primed cytotoxic t cells. aim 2: to determine, in vitro, specific binding and lysis of colorectal cancer cscs by antibodies produced by purified b cells from pbmcs stimulated with colorectal cancer csc-dc.

Eligibility criteria:
inclusion criteria: 1. age:18 and over 2. performance status:karnofsky 70-100% 3. life expectancy:greater than 6 months 4. hematopoietic:absolute neutrophil count at least 1000/mm 3,hemoglobin at least 9 g/dl,platelet count at least 100,000/mm\^3 5. hepatic:bilirubin less than 2.0 mg/dl no chronic or acute hepatic disease renal:creatinine less than 2.5 mg/dl 6. cardiovascular: no chronic or acute cardiac disease (new york heart association class iii or iv) 7. pulmonary: no chronic or acute pulmonary illness such as asthma or chronic obstructive pulmonary disease exclusion criteria: 1. patients receiving anticoagulation therapy. 2. patients receiving any other investigational agents. 3. patients who test positive for hepatitis b virus, hepatitis c virus or hiv. 4、level 3 hypertension; 5、severe coronary disease; 6、 myelosuppression; 7、 respiratory disease; 8、 brain metastasis; 9、 chronic infections
tracking biomarkers of speech intelligibility

Conditions: High-Frequency Hearing Loss

Summary: difficulties understanding speech in noisy environments repeatedly coincide with high-frequency hearing loss. this complaint is commonly exhibited in adults in middle/older age who have a history of noise exposure. in this study, an immersive audiomotor training game will be utilized to drive improvements in speech intelligibility, controlled by an auditory memory training game. physiological measures will be tracked that could inform clinical assessment of hearing in noise abilities.

hearing loss is a chronic health disorder affecting approximately 15 percent of americans. high-frequency hearing loss can be imperceptible when listening in quiet environments. however, in complex noisy environments, individuals can severely suffer from an inability to resolve speech. this is despite having normal audiometric thresholds in the low-frequency range within which speech signals are contained. there are several factors that could contribute to speech intelligibility difficulties that are imperceptible with typical hearing tests. these include impaired temporal encoding at the auditory nerve and the downstream sequelae of peripheral damage in the central auditory pathway. the goal of this study is to assess how a set of physiological measures of auditory/neural processing map onto suprathreshold hearing outcomes. in a previous study, significant improvements in speech intelligibility have resulted from training on an immersive video game. the game uses a closed-loop audiomotor interface design that reinforces sensory-guided feedback. as a control, an auditory memory training game has been developed to replicate user expectations and procedural learning. in this study, an audiomotor game and control game will be used as mechanisms through which to track changes to physiological and perceptual biomarkers in a high frequency hearing loss cohort and a matched normal hearing cohort. tests will be run pre-training, post- training, and at a follow-up point.

Eligibility criteria:
inclusion criteria: * high frequency hearing loss subjects - thresholds of 15 db hl or less for 0.25-2 khz. thresholds of 30-60 db hl from 3-8 khz. * normal hearing subjects - thresholds of 15 db hl or less from 0.5-8 khz. * thresholds between left and right ears symmetric within 10 db for all frequencies. * native english speakers. exclusion criteria: * conductive hearing loss (as assessed by audiologist). * active otologic disease (as assessed by audiologist). * significant cognitive decline (montreal cognitive assessment score \> 25).
efficacy and safety of etelcalcetide (amg 416) in the treatment of secondary hyperparathyroidism (shpt) in patients with chronic kidney disease (ckd) on hemodialysis

Conditions: Hyperparathyroidism, Secondary

Summary: this study is designed to assess the efficacy and safety of etelcalcetide (amg 416) compared with placebo in the treatment of shpt in ckd patients receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * subject understands the study procedures and agrees to participate in the study by giving written informed consent. * subject is 18 years of age or older. * subject agrees to not participate in another study of an investigational agent during the study. * subject must be receiving hemodialysis 3 times weekly for at least 3 months * other inclusion criteria may apply exclusion criteria: * currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening. * other investigational procedures while participating in this study are excluded. * anticipated or scheduled parathyroidectomy during the study period. * subject has received a parathyroidectomy within 3 months prior to dosing. * anticipated or scheduled kidney transplant during the study period. * subject has known sensitivity to any of the products or components to be administered during dosing. * subject has participated in a prior clinical trial of amg 416 * subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the investigator. * subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject. * other exclusion criteria may apply

Keywords: secondary hyperparathyroidism (shpt), chronic kidney disease (ckd), hemodialysis, parathyroid hormone (pth), hypocalcemia, bone and mineral metabolism
modeling clinical outcomes in gambling addiction

Conditions: Gambling Disorder

Summary: gambling disorder (gd) is recognized as an addictive disorder. financial consequences of gd are often dramatic, inducing professional, familial, legal and medical repercussions and particularly mental health consequences. mogador is a longitudinal, multicentric, prospective, prognostic study, which aims to identify factors predicting the evolution of french patients with gd in care centers particularly involved in the management of gd. the main goal will focus on evolution of dsm-5 (diagnostic and statistical manual of mental disorder 5th edition) gd criteria during the first year of follow-up. the prognostic factors will be collected at base-line and they will be considered to influence the long-term prognosis of patients. for patients suffering of gd, our main hypothesis is that initial factors like individual socio-demographic characteristics, clinical psychiatric profiles, addiction comorbidities, and behaviour are associated with the clinical prognosis (total remission of dsm-5 criteria of gd at 12 months). mogador will be the first study, aiming to model prognostic aspects of gb in populations specially monitored for this disorder.


Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years old, consulting in one of the participating centers. * dsm-5 criteria for gambling disorder at inclusion: at least 4 criteria present in the 12 months preceding the study. * first treatment for gambling disorder or no treatment in the last 6 months (initiation or re-initiation of care). exclusion criteria: * unable to be reached by phone. * unable to use the internet. * patient under antiparkinsonian treatment of the dopaminergic family. * being treated with a drug that may trigger/increase symptoms of gambling disorder (e.g. dopamine agonist). * subject under guardianship.

Keywords: gambling disorders modeling outcomes socio-demographic characteristics clinical psychiatric profiles
possible role of roflumilast in diabetic nephropathy

Conditions: Diabetic Nephropathies

Summary: adding roflumilast to the standard therapy for diabetic nephropathy and studying the progression of many outcomes including urinary albumin to creatinine ratio, estimated gfr, biomarkers of diabetic nephropathy


Eligibility criteria:
inclusion criteria: diabetic patients with persistent micro- or macroalbuminuria despite treatment with the maximum tolerated dose of ace inhibitors for at least 8 weeks before the screening and randomization * type i or ii diabetic patient with stage 2 ckd (egfr = 60 - 89 ml/min) ,stage 3 ckd (egfr = 30 - 59 ml/min) or stage 4 (egfr 15-29 ml/min) exclusion criteria: * moderate to severe hepatic disease (child-pugh b or c) severe renal disease (egfr\<15 ml/min) body-mass index below 25 kg/m2 concomitant use of strong cytochrome p450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) known psychiatric illness, congestive heart disease patients with allergy for roflumilast pregnant and lactating women
ct-based radiomic signature can identify adenocarcinoma lung tumor histology

Conditions: Nonsmall Cell Lung Cancer

Summary: lung cancer remains the leading cause of cancer related mortality worldwide, with more than 1.5 million related deaths annually. lung cancer is divided into two main groups: small cell lung carcinoma (sclc) and non-small cell lung carcinoma (nsclc), with prevalence of \~20% and 80% respectively. nsclc is further subdivided into adenocarcinoma (the most common), squamous cell carcinoma (scc), and large cell carcinoma. furthermore, each subtype is likely to have specific mutations, which could be targeted for treatment. medical imaging and radiomics feature extraction represent a candidate alternative to conventional tissue biopsy, a theory that is investigated in this study.


Eligibility criteria:
inclusion criteria: * availability of diagnostic non-contrast enhanced ct scan. * availability of histologic tumor analysis results exclusion criteria: -
exploring heart rate variability, eeg pattern, and corticomuscular coherence after cervical sagittal alignment restoration

Conditions: Cervical Lordosis

Summary: the goal of this randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. the main question it aims to answer: - whether forward head posture (fhp) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination.

background: restoring normal cervical spine alignment has emerged as one of the most important clinical outcomes in healthcare. however, the question of whether cervical biomechanical dysfunction manifesting as forward head posture (fhp) may play a crucial role in affecting heart rate variability, as an indicator of the autonomic nervous system, electroencephalography (eeg) pattern, as indictor for brain waves, and corticomuscular coherence, as an indicator of the functional connection between the cortex and muscles during continuous muscle contractions among collegiate athletes has not been answered yet. objective: to investigate the immediate and long-term effects of cervical lordosis restoration and forward head correction using the denneroll™ on heart rate variability, eeg pattern, and corticomuscular coherence among collegiate athletes. methods: eighty asymptomatic subjects with a definite hypolordotic cervical spine and fhp will be randomly assigned to an experimental group or a control group. the experimental group will receive the denneroll™ cervical traction while the control group will be considered as a wait list to start the intervention after completion of the experimental group. interventions will be applied 3 times per week for a period of 10 weeks. changes in heart rate variability, eeg pattern and corticomuscular coherence will be assessed at three-time intervals: at baseline, after 10 weeks of intervention, and at 6-months follow up with no further interventions.

Eligibility criteria:
inclusion criteria: * anterior head translation (aht) \>15 mm * absolute rotatory angle c2 to c7 is \<25° * athletic student exclusion criteria: * inflammatory joint disease or other systemic pathologies * prior history of overt injury and surgery relating to the musculoskeletal system, or disorder related to the spine and extremities * musculoskeletal pain in the previous three months.

Keywords: cervical lordosis athlete electroencephalography heart rate