Kornimate/medical-research-clean huggingface dataset:
retrospective analysis of 68ga-psma-pet in patients with prostate cancer: experience from brazil

Conditions: Prostate Cancer

Summary: gallium-68-prostate-specific membrane antigen (68ga-psma) positron emission tomography (pet) has been increasingly used in the management of pca in brazil. thus, the detection of metastatic lesions is improved over traditional methods e.g. mri and the diagnosis of mcspc patients has been proportionally increasing. due to a lack of guidelines and clinical trials including 68ga-psma-pet imaging, the management of these patients is extrapolated from data based on conventional imaging. treatment decision and duration of treatment for mcspc patients based on 68ga-psma-pet imaging is currently unknown. 68ga-psma-pet allows a diagnosis of a different set of low volume oligo-metastatic prostate cancer patients. based on that, a new gap has been built up, since there are no standards of how those patients are managed and how they respond to conventional therapies, to metastasis direct therapy or even if they could be spared of any treatment, reducing costs and toxicities. this patient population has not been included in clinical trials and its critical to generate information on the diagnosis, treatment and outcome of these patients in clinical practice.


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years at study entry; 2. histologically confirmed adenocarcinoma of the prostate; 3. 68ga-psma-pet exam performed between october 2015 and january 2021; 4. 68ga-psma-pet performed in one of the following situations: * localized disease at diagnosis in patients with no detection of extra-prostatic disease in traditional imaging such as ct scan, mri and bone scan; * biochemical recurrence (according to pcwg3 or defined by the investigator) in patients with no detection of prostatic or extra-prostatic disease in traditional imaging such as ct scan, mri and bone scan; 5. traditional imaging (pelvic and abdominal ct or mri and bone scan) with negative results (no extra-prostatic disease, for localized and biochemical recurrence disease; no prostatic for biochemical recurrence disease) performed within 8 weeks before 68ga-psma-pet; 6. site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records. exclusion criteria: 1. patients with no disease characteristics accessible in medical records; 2. cancer diagnosis other than prostate cancer in the last 5 years; 3. disease detected by traditional imaging techniques (bone scan, ct and/or mri), meaning extra-prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease.
a study of vis410 to assess safety and pharmacokinetics

Conditions: Influenza

Summary: the purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of vis410 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy volunteers * body mass index between 18 and 33 kg/m2, inclusive * normal labs * volunteers agree to use acceptable contraceptive measures exclusion criteria: * prior receipt of antibody or biologic therapy * history of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias * any chronic condition requiring daily prescription or over the counter medication * history of a previous severe allergic reaction * drug or alcohol abuse within previous 12 months * positive serology for human immunodeficiency virus (hiv) antibody, hepatitis c virus (hcv) antibody or hepatitis b surface antigen (hbsag) * positive pregnancy test * breast feeding * positive drug or alcohol test at screening or check-in * receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration

Keywords: influenza monoclonal antibody
implementation of real-time ade surveillance and decision support

Conditions: Adverse Drug Events

Summary: the purpose of this study is to determine if an electronic alerting technology improves time to intervention for possible ades, identify what factors affect adoption of ade alerts, and whether there is a cost benefit associated with the alerting technology.

inpatient adverse drug events (ades) continue to be a major source of morbidity and mortality despite advances in computerized drug safety measures. reports on the ability of computerized ade alerts to prevent and mitigate ades are lacking. the aims of this project are to 1) assess organizational, social, and cognitive factors that affect adoption of real-time ade alerting technology; 2) analyze the effect of the ade alerting technology on management and rate of ades; and 3) estimate the cost-benefit of the ade alerting technology. this study will use a patient randomized design of computerized real-time ade alerts intended for primary and secondary prevention of ades. the ade alerts promise to reduce mortality, morbidity, and costs due to ades. this study will quantify the effect of the alerts in the hands of first-year medical residents and pharmacists. the study will explore the associations of organizational and soci-cognitive barriers and facilitators with the adoption of the ade alert technology. at the cognitive level, it will explore whether ade alerts change user bias in diagnosing ades or whether the alerts heighten sensitivity to drug problems.

Eligibility criteria:
inclusion criteria: - all patients admitted to the slcvamc at time of study. exclusion criteria: - there are no exclusions.

Keywords: safety management risk management surveillance triggers
study of the effectiveness of additional reductions in cholesterol and homocysteine

Conditions: Cardiovascular Disease

Summary: search is a randomised, double-blind, multi-centre united kingdom (uk) trial of 12,064 patients with myocardial infarction (mi) prior to study entry which aims to demonstrate whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces a larger and worthwhile reduction in cardiovascular events compared with a standard 20 mg daily regimen and whether reducing blood homocysteine levels with a daily dose of folic acid 2 mg + vitamin b12 1 mg compared with matching placebo produces a worthwhile reduction in vascular disease.

in observational studies, lower blood cholesterol concentrations are associated with lower coronary risk, without any clear threshold below which lower levels are not associated with lower risk. cholesterol reduction with statins reduces such risk but there is uncertainty about whether greater reductions with more intensive statin therapy will produce greater benefits. elevated blood homocysteine levels appear to be an independent marker of cardiovascular risk, but it is unknown whether taking vitamins to reduce homocysteine concentrations will translate into cardiovascular benefit. 12,064 survivors of myocardial infarction have been randomised in a 2x2 factorial design to more intensive versus standard cholesterol-lowering treatment, using 80 mg or 20 mg daily simvastatin, and separately to homocysteine-lowering with folic acid plus vitamin b12 or matching placebo. follow-up will continue until there are at least 2800 confirmed major vascular events (mve), defined as non-fatal myocardial infarction, coronary death, stroke or arterial revascularisation. the primary outcome is the incidence of first mve during the scheduled treatment period. search should provide reliable evidence of the effectiveness and safety of more intensive cholesterol-lowering for the reduction of major vascular events in a high-risk population, and of the effects of homocysteine-lowering with folic acid plus vitamin b12.

Eligibility criteria:
inclusion criteria: * prior myocardial infarction * statin therapy indicated * no clear indication for folic acid exclusion criteria: * no clear contraindication to study treatments * screening plasma total cholesterol \<3.5 mmol/l in patient already on statin therapy, or \<4.5 mmol/l in patient not on statin therapy * chronic liver disease * severe renal disease or evidence of renal impairment * inflammatory muscle disease * concurrent treatment with fibrates or high-dose niacin * concurrent treatment with cyclosporin (or condition likely to result in organ transplantation and the need for cyclosporin), nefazodone, methotrexate, systemic azole antifungal or systemic macrolide antibiotics * child bearing potential * no other predominant medical problem (other than coronary heart disease \[chd\]) which might limit compliance with 5 years of study treatment

Keywords: myocardial infarction coronary heart disease cholesterol stroke
intensified rituimab prephase before fcr in untreated b-cll

Conditions: B-cell Chronic Lymphocytic Leukemia CLL

Summary: phase ii, multicenter, randomized trial, exploring intensified rituximab prephase monotherapy before standard fludarabine-cyclophosphamide-rituximab fc-r regimen in previously untreated symptomatic b-cell chronic lymphocytic leukemia cll. a study from the goelams gcfllcmw intergroup

young fit medically b cell untreated patients comparison between fcr treatment = 6 fcr cycles and a the addition of a prephase with r dense treatment before the 6 fcr cycles.

Eligibility criteria:
inclusion criteria: * patient information and written informed consent * 18 years \< age \< 66 ans * confirmed b-cll matutes score 4 or 5 * binet stage c or binet stage a and b with active disease could be considered for inclusion. for stage a with active disease an agreement of investigator coordinator is required. * no prior treatment except steroids for less than 1 month (detail corticoid) * no 17p deletion as assessed by fish \< 10 % positive nuclei * performance status ecog \< 2 * cirs cumulative illness rating scale \< 6 exclusion criteria: * binet stage a without active disease according to iwcll 2008 criteria * know hiv seropositivity * hepatitis b or c seropositivity unless clearly due to vaccination * life expectancy \< 6 months * clinically significant auto-immune anemia * active second malignancy currently requiring treatment (except basal cell carcinoma in situ endometrial carcinoma and incidental prostate carcinoma) and/or less than 5 years cr after breast cancer * any severe co-morbid conditions such as class iii or iv heart failure, myocardial infarction within 6 months, unstable angina, ventricular tachyarythmias requiring ongoing treatment, severe chronic obstructive pulmonary disease with hypoxemia, uncontrolled diabetes mellitus, or uncontrolled hypertension * concomitant disease requiring prolonged use of corticosteroids \> 1 month * known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs according to the smpc or investigator practice * contraindication to use of rituximab * transformation to aggressive b-cell malignancy e.g. diffuse large cell lymphoma, hodgkin lymphoma, or prolymphocytic leukaemia * active bacterial, viral or fungal infection * abnormal renal function with creatinine clearance \< 60 ml/min calculated according to the cockcroft and gault formula * total bilirubin, gamma glutamyltransferase or transaminase levels \> 2.5 uln. * any coexisting medical or psychological condition that would preclude participation in the required study procedures * patient with mental deficiency preventing proper understanding of the requirements of treatment. * pregnant or breastfeeding women. * adult under law-control * fertile male and female patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study. * no afiliate to social security

Keywords: b cll fist line treatment
medical mistrust among hispanic/latino gay, bisexual and other men who have sex with men (hlmsm)

Conditions: Human Immunodeficiency Virus

Summary: there is an urgent need to address hiv inequities and disparities in the us, particularly within vulnerable communities such as hispanic/latino gay, bisexual, and other men who have sex with men (hlmsm).

medical mistrust is associated with hiv disparities among hlmsm because mistrust may result in delayed or reduced use of needed hiv prevention (e.g., hiv testing and pre-exposure prophylaxis (prep) uptake) and care (e.g., antiretroviral therapy \[art\]) services. while advances have been made to increase the use of hiv prevention and care services, profound disparities persist, and a need remains for increased understanding of the multilevel drivers of medical mistrust and for effective interventions to address these drivers among hlmsm in the us. this research proposes a mixed-method study that includes rigorous qualitative and quantitative methods to better understand the drivers of medical mistrust among spanish-speaking, english-speaking, and bilingual (including spanish and english, or an indigenous language and spanish and/or english) hlmsm. this study also proposes to refine and test a multilevel intervention designed to address medical mistrust and increase the use of needed hiv prevention and care services among diverse hlmsm in mecklenburg county, nc, a jurisdiction prioritized by the ending the hiv epidemic in the us (ehe) initiative.

Eligibility criteria:
inclusion criteria: * reside in mecklenburg county, nc * identify as hispanic/latino * be ≥18 years of age * speak english and spanish * report identifying as male and having had sex with at least 1 man in the past 6 months * provide informed consent exclusion criteria: * less than 18 years of age * female

Keywords: hispanic/latino gay bisexual men hiv prevention
treatment of degenerative and neoplastic diseases with rituximab

Conditions: Diffuse Large B Cell Lymphoma

Summary: this is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of pbo-326 (rituximab) and mabthera (rituximab) in combination with chop in previously untreated patients with diffuse b cells non hodgkin lymphoma.

at present r-chop (rituximab plus cyclofosfamide, doxorrubicine, vincristine and prednisone) has became standard of care of patients with b cells non hodgkin lymphoma cd20+. study will perform pharmacodynamic (pd) and pharmacokinetic (pk) measurment of a novel rituximab in comparison with mabthera and evaluates safety both metabolic as well immunologic. study protocolo is designed to provide data on impact of treatment interchange of both study drugs (pbo-326 and mabthera).

Eligibility criteria:
inclusion criteria: 1. newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large b cell non-hodgkin's lymphoma (dlbcl) based on the 2008 world health organization classification. 2. cd20+ lymphoma cells at screening. 3. \> 18 years of age at screening. 4. ann arbor stages i-iv at screening. 5. any ipi score at screening. 6. easten cooperative oncology group (ecog) performance status (0-2) or karnofsky scale \> 60 at screening. 7. left ventricular ejection fraction \> 50%. 8. willing and able to provide written informed consent prior to performing study procedures. 9. women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion. exclusion criteria: 1. hodgkin lymphoma. 2. any lymphoma other than cd20+ diffuse large b cell lymphoma (dlbcl). 3. immunodeficiency syndrome or human immunodeficiency virus (hiv) seropositivity . 4. active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit. 5. function liver tests \>2 x upper normal values. 6. positive hepatitis b surface antigen or antibodies to hepatitis c. 7. any other serious active disease or co-morbid medical condition. 8. subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study. 9. pregnant or breast-feeding women or women that intend to get pregnant during study or within 12 months following the last infusion. 10. treatment with any investigational drug within 90 days before day 1 of study treatment.

Keywords: dlbcl pharmacokinetics pharmacodynamics rituximab lymphomalymphoma non-hodgkinlymphoma b-celllymphoma large b-cell disorders lymphatic diseases immunoproliferative disorders antineoplastic agents adverse effects
validation of an iphone-based event recorder for arrhythmia detection

Conditions: Arrhythmia, Palpitations, Lightheadedness

Summary: in this study, we will evaluate the diagnostic yield of the new alivecor device versus a 14 day event monitor with the use of both devices simultaneously. we will also examine by means of a questionnaire the compliance, ease of use and patient satisfaction for each device. hypothesis: 1. the alivecor monitor will be non-inferior to the 14 day event monitor with respect to diagnosis of the arrhythmia responsible for a patient's symptoms. 2. the alivecor monitor will have better compliance and acceptability compared to the 14 day event monitor, and thus there will be a greater number of days with recordings from the alivecor monitor.


Eligibility criteria:
inclusion criteria: patients \>18 years of age with symptoms such as palpitations or pre-syncope suggestive of arrhythmias (usually occurring less frequently than once a day) with prior non-diagnostic ecgs and/or holter monitoring. patients who own an iphone 4, 4s or 5 device and demonstrate the capability of recording and uploading a test ecg recording at the office visit. exclusion criteria: 1. patients \<18 years of age. 2. patients with a myocardial infarction (mi) within the last three months, and/or known history of sustained vt/vf. 3. patients with nyha class iv heart failure. 4. patients with unstable angina. 5. patients with syncope as the presenting symptom. 6. patients unable to or unwilling to use the device.

Keywords: arrhythmia, palpitations, lightheadedness
a study of cerebral-circulatory response to intravenous antihypertensive treatment in women with serious preeclampsia

Conditions: Preeclampsia

Summary: the purpose of this study is a systematical registration of hemodynamic measurements (cardiac output, blood pressure and systemic vascular resistance) in women with serious preeclampsia.


Eligibility criteria:
inclusion criteria: * women with serious preeclampsia

Keywords: preeclampsia trans cranial doppler cardiac output systemic vascular resistance blood pressure
the treatment of insomnia in patients with hiv disease

Conditions: HIV Infections; Insomnia

Summary: this study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are hiv positive and suffer from insomnia.

insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. this condition is extremely common among hiv infected individuals and can lead to significant distress and reduction in the quality of life. the mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. insomnia has been documented to be one of the most common psychiatric disorders in hiv disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population. comparison(s): two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.

Eligibility criteria:
inclusion criteria: * insomnia * hiv seropositive * stable hiv disease exclusion criteria: * other psychiatric illnesses * unstable hiv disease

Keywords: hiv insomnia cytokines adherence
metabolic syndrome and contrast induced nephropathy

Conditions: Contrast Induced Nephropathy; Metabolic Syndrome

Summary: prevention of contrast induced nephropathy after interventional cardiologic procedures deserves close interest because of its association with prolonged hospitalization, increased cost and increased in hospital and long term mortality rates. an observational prospective cohort study was designed to determine whether metabolic syndrome predicts the development of contrast induced nephropathy after elective percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: patients must be scheduled for elective percutaneous coronary intervention clinical diagnosis of metabolic syndrome patients must give informed consent exclusion criteria: acute coronary events acute renal failure end stage renal failure requiring hemodialysis contrast allergy and exposure to nephrotoxic agent within 1 week before percutaneous coronary intervention exposure to contrast agent within 1 week before the procedure.

Keywords: creatinine glomerular filtration rate metabolic syndrome
follow-up of children after stuttering treatment

Conditions: Stuttering

Summary: this study aims to determine the percentage and predictors of stuttering relapse following treatment with the lidcombe program. it will also investigate the effectiveness of sending reminder messages to parents to assist in reducing relapse.

stuttering treatment becomes more time-consuming and less effective as children become older. therefore it is crucial to prevent relapse following treatment in the early years. this study will investigate predictors of relapse and assess the effectiveness of a simple two-weekly user-friendly reminder to parents, about when and how to address any re-occurring stuttering after treatment. results from the study may help to prevent stuttering relapse in this age group in the future.

Eligibility criteria:
inclusion criteria: * completion of stage i of lidcombe program * less than 1 percent syllables stuttered at recruitment * means of receiving sms email or phone reminder

Keywords: stuttering relapse lidcombe program preschool children
evaluation of knowledge and practice about prostate cancer in male employees

Conditions: Prostate Cancer

Summary: analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of a pharmaceutical company.

in brazil, there are still few published and current studies that explore man's attention and awareness of health. historically, women attend medical appointments and perform routine tests more frequently than men. for this is very important analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of libbs farmacêutica (a pharmaceutical company in brazil).

Eligibility criteria:
inclusion criteria: * male individuals included in the libbs workforce; * age 18 years or older; * subjects who agree to participate in the study after reading and signing the informed consent form. exclusion criteria: * there is no exclusion criteria