Kornimate/medical-research-clean huggingface dataset:
race, class, and gender--studies of health effects

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to improve understanding of three important and intertwined social determinants of health: social class, race/ethnicity, and gender.

design narrative: the first component of the study investigated associations among discrimination, blood pressure, and cardiovascular risk factors, and used data from exam iv (1992-1993) of cardia, a multi-site longitudinal study of cardiovascular risk factors among black and white men and women. analyses examined the association between blood pressure and discrimination based on race/ethnicity, gender, social class, sexual orientation, and religion, and took into account response to unfair treatment. to assess for effect modification, separate analyses were performed for the eight strata defined by the sampling strategy: black/white x male/female x equal to or less than high school/more than high school. additional multivariate analyses examined whether, within the four gender/education strata, discrimination contributed to black/white differences in blood pressure, adjusting for relevant covariates. other analyses explored the relationship between discrimination, response to unfair treatment, and other possible cardiovascular risk factors, including hostility, body fat distribution, lipid fractions, blood glucose, skin color, substance use (tobacco, alcohol, and illegal drugs), and body self-image. the second component concerned appropriate measures of social class for studies of women's health. it used data on 718 women who participated in examination ii of the kaiser permanente women twins study (1989-1990) . socioeconomic information existed on: adult individual and household class (which took into account the individual class position of both the respondent and her partner or head-of-household, if present), childhood household class, and class trajectory (comparing childhood and adult household class). data on health characteristics included: blood pressure, body mass index, waist-hip ratio, lipoprotein fractions, fasting and postload insulin and glucose serum concentrations, self-assessed health status, age at first completed pregnancy, total number of childbirths, duration of breast feeding, physical activity, and smoking status. analyses evaluated whether different magnitudes of class-based differences in these health characteristics were detected with these diverse measures of social class, using multivariate techniques that corrected for the correlation of errors within twin pairs. the effects of using these different class measures were also examined for analyses testing the hypothesis that social class was inversely related to risk of hypertension among women, adjusting for relevant covariates. 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
a phase i/ii study of sunitinib malate (su011248) in patients with gastrointestinal stromal tumor (gist)

Conditions: Gastrointestinal Stromal Tumors

Summary: phase i;to investigate the clinically recommended dose of sunitinib malate (su011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability. phase ii;to determine the objective tumor response and the safety of sunitinib malate (su011248) at the clinically recommended dose.


Eligibility criteria:
inclusion criteria: * patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (gist). * patients previously treated with imatinib mesylate. exclusion criteria: * patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate. * any tumor therapy for gastrointestinal stromal tumor (gist) discontinued less than 4 weeks prior to starting study treatment. imatinib mesylate discontinued less than 2 weeks prior to starting therapy.

Keywords: evaluate of rtd for japanese gist patients
placebo-controlled evaluation of ropivacaine efficacy by local infiltrations

Conditions: Hepatectomy; Pain; Metastasis

Summary: the purpose of the study is to evaluate the efficacy and impact on morphine consumption of ropivacaine administered by local per and post hepatic surgery infiltration. patients will be randomized to either ropivacaine or physiological serum, with equivalent administration modalities in both arms. patients will be followed during 4 days after the surgery. they will also come back for a follow-up visit one month later. it is necessary to enrol 100 patients. the estimated period of inclusion is 24 months. this is a prospective, comparative, monocentric, double-blind randomized study.


Eligibility criteria:
inclusion criteria: * male or female patients aged ≥ 18 years * patients with histologically confirmed cancer * patients treated at the centre léon bérard * patients requiring a surgery for hepatic metastases * asa \<= 3 * at least 3 weeks between surgery and chemotherapy * total bilirubin \< 1.5 x upper limit of normal range * asat and alat \< 5 times x upper limit of normal range * creatinine clearance \> 60 ml per hour * serum creatinine \< 115 µmol/l * mandatory affiliation with a health insurance system * patients able to understand french * signed, written informed consent exclusion criteria: * patients with a hepatocellular carcinoma or an initial liver cancer * patients treated chronically by morphine * patients that already have abdominal pain * patients who are allergic either to morphinics, local anesthesics, paracetamol, nsaid or cortisone * patients suffering from heart, kidney or liver insufficiency * documented history of cognitive or psychiatric disorders * pregnant or lactating women * difficult follow-up
a safety and efficacy study of revlimid® 5 mg capsules in patients with relapsed or refractory multiple myeloma who have received long-term treatment with it under the actual condition of use

Conditions: Multiple Myeloma

Summary: to understand the safety and efficacy of revlimid® 5 mg capsules (hereinafter referred to as revlimid) in patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory mm") who have received long-term treatment with it under the actual condition of use. 1. planned registration period this period started on the date of initial marketing of revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths). 2. planned surveillance period this period started on the date of initial marketing of revlimid and will end 3 years after the last enrolled patient begins receiving revlimid (estimated to be approximately 4 years and 3 months).


Eligibility criteria:
inclusion criteria: * relapsed or refractory mm patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance. exclusion criteria: n/a

Keywords: multiple myeloma teratogenicity thrombocytopenia and haemorrhage neutropenia and infection venous thromboembolism allergic reactions diarrhoea or constipation peripheral neuropathy cardiac failure arrhythmia renal failure myocardial infarction interstitial lung disease tumour lysis syndrome
hfnc effect on bcss in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary objective of this study is to look for a correlation between the use of high-flow nasal cannula in the outpatient setting in patients with previous chronic obstructive pulmonary disease exacerbation and the change in their breathlessness, cough, and sputum scale score. the hypothesis is that home use of high-flow nasal cannula will lead to a reduction in breathlessness, cough, and sputum scale score by 1.3.

this is a prospective pilot study. targeted population include patients with chronic obstructive pulmonary disease , non-oxygen dependent, with a baseline normal bicarbonate on previous lab (within 6 months of enrollment). patients will be randomly selected to be part of the study sample. recruitment will occur in both inpatient and outpatient settings. an email briefly explaining the objectives of the study will be sent to internal medicine residents and pulmonary critical care fellows to help in patients' recruitment. patients will be enrolled in the study only after being seen by dr. abdo or dr. allen. the study is expected to finish by the end of january 2017 or twelve months post institutional review board approval. patients will be recruited and enrolled over six months, and the collected data will be analyzed six months after the last patient was included in the study. the study will target a study sample of 30 as detailed in the statistical analysis section, where patients will be their own control (3 months without high-flow nasal cannula followed by 3 months with high-flow nasal cannula).

Eligibility criteria:
inclusion criteria: one previous chronic obstructive pulmonary disease exacerbation in last year. exclusion criteria: can not be oxygen dependant paco2 \< 60

Keywords: chronic obstructive pulmonary disease
chorus sleep trial

Conditions: Sleep Disturbance

Summary: this pilot study will evaluate the feasibility of a 6-week intervention using chorus sleep's ios app to improve sleep quality, reduce stress, and reduce depression and anxiety using a randomized controlled design.

chorus sleep is a successful wellness company with a loyal and growing clientele, and considerable qualitative and anecdotal evidence for its efficacy at reducing stress, and improving sleep quality. it builds upon existing meditation and mindfulness practices with well documented efficacy for reducing pain, improving mental health, and reducing stress. further its innovative approach - including the use of popular music and breathwork patterns that elicit stimulating and novel sensations and physiological activity - may removes barriers to participation and engagement of many traditional meditation and mindfulness practices. prior research evaluating the efficacy of audio meditation using the calm app found use of the app for eight weeks significantly decreased daytime fatigue and sleepiness and pre-sleep arousal compared to a wait-list control group. further, use of the calm app for 8 weeks was associated with greater improvements in depression and anxiety symptoms, and those effects were mediated by lower pre-sleep arousal. this study will investigate whether chorus sleep's innovation in auditory app-based sleep inventions will demonstrate similar efficacy. this study has the following objectives: 1. pilot a randomized controlled trial on chorus sleep to evaluate feasibility. 2. evaluate the effect of chorus sleep practice at improving sleep quality. 3. evaluate the effect of chorus sleep practice at reducing perceived stress, depression, and anxiety, both directly and indirectly through improved sleep quality. 4. characterize habit formation of chorus sleep practice

Eligibility criteria:
inclusion criteria: * fluent english speakers * have an apple iphone 8 or later * have a bed to sleep in consistently every night exclusion criteria: * narcolepsy * night shift or shift work for more than 2 nights per week. * used the chorus sleep app more than one time prior to the beginning of the trial.

Keywords: mindfulness breathwork meditation
motivational enhancement therapy to improve treatment utilization in pregnant substance users - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to compare motivational enhancement therapy (met) with standard drug abuse treatment among pregnant women.


Eligibility criteria:
inclusion criteria: * pregnancy \<30 weeks * have not attended drug treatment in past 28 days * not needing residential treatment (except detox) * not at risk for suicide/homicide * have no pending legal charges (except drug treatment)

Keywords: behavioral intervention
a study to learn more about the use of aflibercept in routine medical practice in japanese participants with neovascular age-related macular degeneration and diabetic macular edema

Conditions: Neovascular Age-related Macular Degeneration (nAMD); Diabetic Macular Edema (DME)

Summary: this is an observational study in which data already collected from participants with neovascular age-related macular degeneration (namd) or diabetic macular edema (dme) is studied. in observational studies, only observations are made without participants receiving any advice or any changes to healthcare. the eye disorders, namd and dme, affect the macula, the central part of the retina at the back of the eye. this leads to blurry vision or blind spots, making everyday activities like reading or sewing difficult. while namd is linked to aging, dme is related to diabetes. both conditions require similar treatment to help improve vision. aflibercept 8 milligrams (mg) is already approved in japan for doctors to prescribe to people with namd or dme. it is a drug injected into the eye. it works by blocking a protein called vascular endothelial growth factor (vegf), which causes abnormal growth and leakage of blood vessels at the back of the eye. the participants in this study are already receiving treatment with aflibercept 8 mg as part of their regular care from their doctors. there is limited data available on the use of aflibercept 8 mg in japan. data from routine medical practice will inform treatment in japanese and other asian populations. the main purpose of this study is to learn more about the disease and patient characteristics of japanese participants with namd and/or dme who receive aflibercept 8 mg during their routine healthcare, and how they use it. to learn this, the study will use 2 methods: method 1: researchers will study the health details of participants when they first started aflibercept 8 mg. method 2: researchers will study the participants' data collected over 1 year to see how they used aflibercept 8 mg. the data will come from a claims database called desc healthcare inc. the data will be collected from april 2023 to march 2025 for method 1, and from april 2023 to march 2026 for method 2. researchers will only look at the information from participants in japan. in this study, only available data from routine care are collected. no visits or tests are required as part of this study.


Eligibility criteria:
inclusion criteria: * patients who are prescribed aflibercept 8 mg during the observable period from the collected data. exclusion criteria: * patients in the namd cohort or namd and dme cohort who have the icd-10 codes for namd who are aged \<40 years old. * patients in the dme cohort or others who are aged \<18 years old. * female patients who have any pregnancy-related records. * patients who do not have at least 365 days of continuous enrollment in the database.
a comparison of risperidone and aripiprazole for treatment of patirnts with methamphetamine-associated psychosis

Conditions: Methamphetamine Dependence

Summary: methamphetamine-associated psychosis (map) has been considered a pharmacological or environmental pathogen model of schizophrenia (scz) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. both risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.this study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with map.

methods:a multiple-center, randomized, double-blind.

Eligibility criteria:
inclusion criteria: 1. patients,diagnostic and statistical manual of mental disorders 4thed. (dsm-iv) criteria for methamphetamine-associated psychosis. 2. must sign a information consent form. 3. required to provide detailed address and phone number exclusion criteria: 1. serious organic disease. 2. suicide ideation or hurt others. 3. taking antipsychotic within two weeks before. 4. drug allergy to risperidone or aripiprazole. 5. pregnancy and breastfeeding women.

Keywords: methamphetamine-associated psychosis aripiprazole risperidone
the epidemiological study on psychiatric disorders and psychotropic drugs

Conditions: Psychiatric Disorders

Summary: during the past decade, the dramatic change in patterns of both psychiatric diagnoses and prescription of psychotropic agents has been noted since the introduction of newer antidepressant drugs. in the meantime, suicide has been recognized as a major public health problem all over the world. research efforts have hence been spent in exploring the interrelationships between suicide rates and prescription of antidepressant drugs (as a proxy for the treatment of depression). however, most available studies came from developed countries despite that the majority of countries with rising suicide rates during the past decade were developing countries. both suicide rates and prescription of antidepressant agents have been rising in taiwan during the past decade; with a reliable mortality registrar and nationwide health insurance covering 99% of its population, taiwan is distinctive in realizing a large-scale analysis on these interrelationships between suicide and prescription of antidepressant drugs. however, there has been no study in taiwan exploring these potential associations up to now. this study aims at examining the interrelationships between suicide rates and prescription of antidepressant agents based on the health insurance data from persons who had diagnoses of icd: 290-319 or were prescribed with antidepressant agents during the period from 1998 to 2006. the investigators plan to first perform correlation analyses between the trends of suicide rates and prescription of antidepressants during the study period after taking into accounts potential confounding factors; analyses by age, gender groups and by administrative regions will also be performed. besides, the investigators plan to analyze the change in the prescription pattern of psychotropic agents in taiwan during the study period, with the particular focus on that of newer antidepressant drugs. the prescription of psychotropic agents in both psychiatric and non-psychiatric diagnoses will be explored.


Eligibility criteria:
inclusion criteria: * psychiatric disorders exclusion criteria: * without psychiatric disorders
study of genetic polymorphisms of drug transporters and orphan nuclear receptors on treatment effects of irinotecan

Conditions: Colorectal Neoplasms; Secondary

Summary: from 100 colorectal cancer patients being treated with folfiri regimen or any kind of irinotecan containing regimen, blood samples for irinotecan and its metabolites levels and genotypes related with its metabolism will be collected. the association of their levels and genotypes and treatment effects will be evaluated.

for the genotype-pd association, 50 colorectal cancer patients treated with folfiri will be enrolled and studied. 50 additional colorectal patients treated with any kind of irinotecan containing regimen will be enrolled and including the 50 patients for the genotype-pd association, a total of 100 patients will be evaluated for the genotype-pk association. blood samples for pk analysis will be collected from patients with colorectal cancer during 1st treatment cycle of irinotecan and 2nd, 3rd infusion. during the 1st treatment cycle, blood will be drawn 0 h (before irinotecan infusion), 0.75 h, 1.5 h and each at time ranges of 2\~8 h, 8\~16 h, 24\~32h and 48\~52 hours after the start of irinotecan infusion over 90 min and additional blood will be collected 48\~52 hours after the respective 2nd and 3rd infusion. for 50 colorectal cancer patient treated with folfiri regimen, responses to the treatment will be assessed every 3 cycles. all assessments will be repeated at the end of trial therapy. the recist criteria for measurable disease will be followed and toxicity will be evaluated according to nci common toxicity criteria version 3.0. time to disease progression will be calculated from the date of study entry to the first objective documentation of progressive disease. response duration will be measured from the date a patient first fulfills the cr or pr criteria to the first date of objective documentation of disease progression.

Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed unresectable or metastatic colorectal cancer * performance status of 0, 1 and 2 on the ecog criteria * disease status must be that of measurable disease as defined by recist criteria (for genotype-pd study only) only non-target lesions are allowed for pk study * no previous chemotherapy, radiotherapy on the target lesion, immunotherapy; adjuvant chemotherapy with fluoropyrimidines completed at least 6 months ago is allowed (for genotype-pd study only) previously treated patients are allowed for pk study * life expectancy of more than 3 months (for genotype-pd study only) * adequate major organ functions * compliant patient who can be followed-up adequately * informed consent exclusion criteria: * active or uncontrolled infection * pregnant or breast-feeding women * patients with systemic disease, especially cardiovascular disease, who cannot tolerate systemic chemotherapy * patients with brain metastasis (for genotype-pd study only) * patients treated with radiotherapy within 2 weeks (for genotype-pd study only)

Keywords: colorectal neoplasms secondary irinotecan pharmacokinetics pharmacodynamics slco1b1 pxr