Kornimate/medical-research-clean huggingface dataset:
vantas implant retrieval study

Conditions: Prostate Cancer

Summary: the main study objective was to collect implant retrieval information in 10 patients using vantas®, the 50 mg histrelin implant. patients who had been identified as having a difficult to locate or non-palpable implant were to have been enrolled. sites were to adhere to the instructions in the package insert, which included specialized investigations such as ultrasound, ct, and mri, to be used for the location and removal of implants.

up to 50 centers using vantas, the recently approved histrelin implant as part of their urology practice for treating patients with advanced prostate cancer, were to be identified for participation in this phase iv post-marketing trial. up to 10 patients who had been implanted with vantas at these participating centers, and who had difficult to locate or non-palpable implants at the time of removal, were to be enrolled in this trial. a screening visit was to be conducted to consent the patient and to collect basic medical and safety information for patient participation. upon patient enrollment, up to three subsequent visits (visits 1, 2, and 3) were to be conducted (within 2 weeks of the screening visit). the investigator was to locate and remove the implant by following the instructions provided in the protocol. methods for location of the implant included ultrasound, ct, or mri procedures. the visit at which the implant was successfully located and removed was to be the final study visit for the patient. upon successful retrieval of the implant or a determination that, per study instructions, the implant cannot be located/removed, the study was completed for the patient. no information was to be collected on re-implantation of a new implant. safety was to be monitored throughout the two week study. blood samples for testosterone and psa were only collected at the screening visit. the implants removed from the patients were to be returned to indevus pharmaceuticals for analysis.

Eligibility criteria:
inclusion criteria: * were male patients with adenocarcinoma of the prostate; * were age 45 years or older; * had received a vantas® implant; * had difficult to locate or non-palpable implant at time of implant retrieval; * had the ability to undergo ultrasound, and/or ct, and/or mri within two weeks of screening visit; * voluntarily provided informed consent prior to the performance of any study-specific procedures. exclusion criteria: * major medical or psychiatric illness that would interfere with return visits; patient not suitable (e.g., noncompliance history) for study in opinion of the investigator or sponsor; * participated in a clinical trial for an investigational agent within 30 days prior to the screening visit (unless enrolled in protocol 301 extension).

Keywords: prostate cancer implant retrieval
vaccine response to covid-19 vaccines in patients using immunosuppressive medication

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis; Crohn Disease; Ulcerative Colitis; Autoimmune Hepatitis; Liver Transplant; Complications

Summary: the purpose of this study is to assess the strength and duration of the immunological response to covid-19 vaccines in patients treated with immunosuppressive and/or immunomodulating medication for immune-mediated inflammatory diseases in rheumatology and gastroenterology and after a liver transplantation.

patients on long-term immunosuppressive and/or immunomodulating medication may be susceptible to serious covid-19. hence, it is important they get sufficient protection by a covid-19 vaccine. however, these patients may also be at risk for a less robust vaccine response. there is an urgent need to assess the humoral and cellular immune response to covid-19 vaccines in these patient groups. the clinical consequences could be to administer several re-vaccinations or to adjust medication. this prospective, observational study aims to assess the immune response after covid vaccination in patients suffering from inflammatory diseases and using immunosuppressive medication. also, liver transplanted patients on immunosuppressive medication will be included. serum and whole blood samples will be obtained from all participants before and 1-4 weeks after the vaccination. additionally, serum samples will be collected every 3-6 months for 5 years. if patients are allotted further vaccine doses , the patient response will be assessed by blood tests 2-4 weeks after any additional vaccine doses. in a subset of patients, samples will be drawn to study cellular immune responses. demographic data and data regarding immunosuppressive medication will be recorded. disease activity (clinical activity indices and biomarkers of inflammation) will be assessed. blood samples will be obtained for biobank. information regarding vaccination status and potential covid-19 testing will be obtained from relevant registers.

Eligibility criteria:
inclusion criteria: 1. an established clinical diagnosis of one of the following immune-mediated diseases: rheumatoid arthritis (ra), spondyloarthritis (spa), psoriatic arthritis (psa), ulcerative colitis (uc,) crohns disease (cd), autoimmune hepatitis (aih) or patients who have undergone a liver transplantation 2. treatment with relevant immunosuppressive and/or immunomodulating medication \* 3. adult patients (\> 18 years) 4. patient intends to obtain vaccination against covid-19 during the next 6 months * \* the following drugs are considered relevant immunosuppressants and/or immunomodulators and patients using them may be eligible for this study: rituximab, infliximab, adalimumab, golimumab, certolizumab, etanercept, tocilizumab, abatacept, secukinumab, vedolizumab, ustekinumab, risankizumab, methotrexate, sulfasalazine, leflunomide, azathioprine, 6-mercaptopurine, tofacitinib, filgotinib, baricitinib, upadacitinib, tacrolimus, mycophenolate, prednisolone exclusion criteria: 1) allergy or intolerance to elements of the covid-19 vaccines -
thorough qt (tqt) study to evaluate the effect of lc350189 on cardiac repolarization in healthy male and female subjects

Conditions: Hyperuricemia; Gout; Qt Interval, Variation in

Summary: this is a phase 1, single-center, randomized, partially double-blind, placebo- and positive controlled, 4-way crossover study to evaluate the effect of a therapeutic and a supratherapeutic dose of lc350189 on the qtcf in healthy male and female subjects.


Eligibility criteria:
inclusion criteria: * the subject is 18 to 55 years of age, inclusive, with a body mass index (bmi) 18 to 33 kg/m2, inclusive, at screening. * the subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ecg results, and physical examination findings at screening. * the subject is able to provide written informed consent and agrees to comply with all protocol requirements. exclusion criteria: * the subject has a history of risk factors for torsades de pointes, including unexplained syncope, known long qt syndrome, heart failure, myocardial infarction, or angina. * the subject has a family history of long qt syndrome, brugada syndrome, or sudden death. * the subject has a resting hr of \ 100 bpm when vital signs are measured at screening or check-in. * the subject has history or presence of unstable cardiovascular disease, including myocardial infarction, cardiac arrhythmia, or cerebrovascular disease (eg, cerebrovascular accident/stroke or transient ischemic attack). * the subject has a history of other acute or chronic cardiovascular disease or coronary revascularization surgery (eg, coronary artery bypass graft, percutaneous transluminal coronary angioplasty). * the subject uses a cardiac pacemaker. * the subject has a history of any other medical, psychological, or social condition that, in the opinion of the investigator or the medical monitor, would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern to the subject.
changes in biomarkers using prostaglandin inhibitors

Conditions: Biomarker Change Linked to Breast Cancer

Summary: this is a biomarker study with the goal of measuring changes in proteins and gene methylation. this study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. the purpose of this study is to determine if vitamin d (cholecalciferol) alone and in combination with celecoxib (celebrex, a non-steroidal anti-inflammatory drug, or nsaid), act together to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called pge2, cox-2, and 15-pgdh) and cell changes in the breast.

this is a biomarker study with the goal of measuring changes in protein and rna expression. this study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. 66 women at normal risk for developing breast cancer will be recruited and enrolled. 22 women will be randomized into each arm, with anticipation of 2 women in each group will not be evaluable, leaving 20 in each group for evaluation. a combination of vitamin d and celecoxib act synergistically to decrease breast cancer risk by decreasing cell proliferation in the mammary epithelium through their action on prostaglandin synthesis and metabolism. specific aims: -evaluate vitamin d metabolism, through the measurement of cyp24 in the breast. 2-evaluate breast specific levels of vitamin d and celecoxib, and assess if the levels of these compounds correlate with response to markers which influence prostaglandin synthesis and metabolism. additionally, in women without active breast cancer , we will determine the effect of vitamin d, with or without celecoxib, on 1) pg synthesis and metabolism, through the measurement of pge2, cox-2 and 15-pgdh in the breast, 2) proliferative activity in the breast,, and 3) circulating levels of vitamin d and celecoxib, to determine if levels of these compounds correlate with response to markers of pg production, metabolism, or cell proliferation.

Eligibility criteria:
inclusion criteria: * woman \>18 years old * healthy women who are at normal risk for developing breast cancer * ecog performance status score 0-1 * premenopausal women must not be pregnant exclusion criteria: * history of bilateral mastectomy, or bilateral breast irradiation * significant medical or psychiatric problems making the participant a poor candiate * evidence of excess use of narcotics or drug dependency * have been pregnant and lactating in the past 2 years * significant history of peptic ulcer disease or upper gastrointestinal bleeding * history of severe congestive heart failure that requires hospitalization or intervention * history of asthma requiring medication for treatment * allergy to sulfonamides or nsaid medications * history of myocardial infarction or stroke * currently on coumadin * currently on tamoxifen (nolvadex),evista (raloxifene), femara (letrozole), arimidex (anastrozole), or aromasin (exemestane) * undergone prior subaeolar breast surgery

Keywords: breast high risk women biomarkers vitamin d
impact of unexpected death in simulation: skill retention, stress and emotions

Conditions: Crisis Resource Management (CRM) Skills; Stress; Advanced Cardiovascular Life Support (ACLS) Skills

Summary: some educational researchers deliberately induce stress upon learners to in order to enhance retention; this practice is controversial and its utility must be weighed against the negative emotional effects it may have on participants. in this study we investigate the effect of the unexpected death of a simulation mannequin on the retention of non-technical and technical crisis resource management skills and consider the emotional impact of this acute stressor.

background high-fidelity simulation is an increasingly used teaching tool that is proven to be effective for learning. according to the literature, by gradually increasing stress and emotions, more effective learning can be achieved. however, allowing the simulated patient to "die", as a deliberate stressor, is controversial. there is no previous research on the educational effect of letting a simulated patient die. we aim to evaluate the effects of simulated unexpected death on skill retention, stress levels, and emotions. we hypothesize that the occurrence of unexpected death will impact skill retention, and will be associated with higher stress levels and stronger emotions. methods after institutional research ethics board approval, 56 residents and fellows of different medical specialties will be randomized to either the intervention (unexpected death) or control (survive) group. participants from both groups will have to individually manage a simulated cardiac arrest crisis. in the intervention group, the scenario will end by the death of the simulated patient, whilst in the control group the simulated patient will survive. each participant will be immediately debriefed by a trained instructor. three months later, skill retention will be assessed in a similar scenario. crisis management performance of all scenarios will be rated by 2 blinded raters. biological stress, cognitive appraisal, and emotions will be measured during both scenarios. implications the impact of simulated unexpected death on skill retention of residents and fellows will provide instructors with evidence to optimize scenario design and approach the role of stress and emotions in simulation-based education.

Eligibility criteria:
inclusion criteria: * must be a resident or a fellow in the department of anesthesiology, critical care, emergency medicine, medicine, obstetrics and gynecology, surgery or family medicine at the university of ottawa or the university of toronto * participants are requested to refrain from physical strains, smoking, drinking caffeinated or low ph beverages and eating for at least one hour before enrollment * participants will be included between 11 am and 8 pm, when cortisol levels are most stable exclusion criteria: * not a resident or fellow in one of the departments indicated above

Keywords: crm skills acls simulation stress
a study in older subject to evaluate the safety and ability of andexanet alfa to reverse the anticoagulation effect of rivaroxaban

Conditions: Bleeding

Summary: the purpose of this study is to evaluate the ability of andexanet alfa to reverse the anticoagulation effect of rivaroxaban.


Eligibility criteria:
inclusion criteria: * reasonably healthy men and women aged 50 to 75 exclusion criteria: * history of abnormal bleeding, active bleeding or risk factors for bleeding * history of thrombosis or risk factors for thrombosis * history of adult asthma or use of inhaled medications

Keywords: andexanet alpha anticoagulation antidote rivaroxaban anti-fxa inhibitor prt4445 xarelto reversal agent
open label, safety study of en3270 in patients with moderate to severe non-malignant, chronic pain

Conditions: Chronic, Non Malignant Pain

Summary: two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. up to 80 patients at approximately 15 centers in the us to be enrolled. study participation is approximately 3 months.


Eligibility criteria:
inclusion criteria: * opioid experienced * hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy * on a stable dose of opioid medication for greater than or equal to 14 days * have an adequate personal support system including a co-habitant * are able and willing to follow verbal and written instructions and provide written informed consent exclusion criteria: * are pregnant or lactating * have pain secondary to a confirmed or suspected neoplasm * have a history or physical examination finding incompatible with safe participation in the study * have a history of alcohol or drug abuse * have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis) * have a history of or currently manifesting a clinically significant psychiatric disorder * have a known history of allergy that negatively impacts respiratory function to a clinically significant level * plan to have an mri while on the study * have any clinically significant condition that would, in the opinion of the investigator, preclude safe study participation * are scheduled for surgery requiring general anesthesia within the study period
short versus long duration of therapy for streptococcus pneumoniae bloodstream infections

Conditions: Streptococcus Pneumoniae

Summary: streptococcus pneumoniae is a gram-positive (gp) bacteria responsible for common infections such as community-acquired pneumonia (cap), as well as complicated infections such as bacteremia, infective endocarditis and meningitis. s. pneumoniae bacteremia ranks among the top 10 most common pathogens associated with bloodstream infections and correlates with high morbidity and mortality worldwide.

the infectious diseases society of america (idsa) guidelines for cap management advocate for short courses of antibiotics for cap treatment. however, it does not address duration of therapy for common cap pathogens such as s. pneumoniae when associated with blood stream infections (bsi). 3 currently, gp bacteremia duration of therapy typically ranges from 7 to 14 days based on idsa guideline recommendations for staphylococcus aureus bacteremia with no further definitive consensus.4 additionally, lack of data and randomized clinical trials on the efficacy and safety of short compared to long treatment duration have led to variability in practice. most randomized clinical trials as well as retrospective studies on treatment duration, have been conducted mainly in gram-negative bsi

Eligibility criteria:
inclusion criteria: * • ≥18 years of age * s. pneumoniae isolated from ≥1 blood cultures * active iv antibiotic therapy within 48 hours of the first positive blood culture(7,8) * clinical stability by day 10 of therapy exclusion criteria: * • treatment duration \ 16 days * death before completion of therapy (\<10 days vs. ≥ 10 days ) * polymicrobial bsi * invasive infection caused by s. pneumoniae (endocarditis, meningitis, and lung abscess)
music for sleep-onset insomnia

Conditions: Insomnia

Summary: the study is a randomized controlled trial evaluating the effect of bedtime music as an early intervention for sleep-onset insomnia in adults. the investigators use a randomized controlled trial design with two parallel groups. all participants receive sleep hygiene advice as standard treatment and participants in the intervention group are additionally asked to listen to a sleep playlist daily at bedtime. subjective and objective sleep measures are evaluated before and after the 4 weeks intervention period. in addition, follow-up measures of subjective outcomes are assessed 4 weeks after the end of the intervention period.


Eligibility criteria:
inclusion criteria: * sleep-onset insomnia for 3-18 months exclusion criteria: 1. use of medications (benzodiazepines, z-drugs, antidepressive and anti-psychotic drugs) 2. alcohol or substance abuse 3. pregnant or breastfeeding women 4. other sleep disorders (e.g. sleep apnea, restless leg syndrome, etc.) 5. current psychiatric disorder or a history of psychotic disorders 6. somatic disorders interfering with sleep (e.g. critical illness, pain disorders, neuro-degenerative disorders) 7. shift work.
feasibility study of auditory brainstem implant in young children

Conditions: Bilateral Cochlear Aplasia; Bilateral Cochlear Nerve Deficiency; Bilateral Cochlear Ossification Secondary to Meningitis

Summary: current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. an auditory brainstem implant (abi) places an electrode close to the auditory nucleus in the brainstem. children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an abi and followed for 1 year for safety and a total of 3 years for preliminary efficacy. this is a feasibility study to determine the safety of the abi.


Eligibility criteria:
inclusion criteria: * bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis * if previously received a cochlear implant, must demonstrate lack of benefit from that device exclusion criteria: * medical contraindication to craniotomy/intracranial surgery * severe cognitive or developmental delays
burden of chronic kidney disease (ckd), type 2 diabetes mellitus (t2dm), and comorbid t2dm/ckd in alberta, canada

Conditions: Chronic Kidney Diseases; Type 2 Diabetes

Summary: the purpose of the research study is to describe the burden of disease among three different cohorts of patients: (1) patients diagnosed with ckd, (2) those with t2dm; and (3) those with t2dm and comorbid ckd.

chronic kidney disease (ckd) has been ranked as the 10th leading cause of death in canada as of 2013, while type 2 diabetes mellitus (t2dm) is one of the fastest growing diseases in canada. there is a growing body of evidence that has examined these populations in real-world settings in canada. the study described below will add to the growing body of literature that has examined ckd patients in alberta and will contribute to an understanding of the epidemiology of ckd by stage, as well as healthcare resource utilization (hcru) and costs. furthermore, this study will contribute to a more nuanced understanding of the epidemiology, treatment patterns, hcru and costs, and adverse events for t2dm patients with and without comorbid ckd in alberta.

Eligibility criteria:
inclusion criteria (either of the following): * chronic kidney disease identified using laboratory test and health administrative data * type 2 diabetes mellitus identified using health administrative data exclusion criteria: * age \< 18 years
evaluating immune response to seasonal flumist in healthy adults

Conditions: Influenza

Summary: the live-attenuated influenza vaccine (laiv), also known as flumist, has been shown to be effective in children but less effective in adults. our hypothesis is that this relative failure is due to adults having enough anti-flu iga antibody in nasal secretions to neutralize the weakened vaccine virus.

this is a va-based study to evaluate serum and nasal wash antibody responses to seasonal laiv of healthy veterans and va employees between the ages of 20 and 49 years old. specific aims 1. the primary aim of the study is to evaluate whether people with high mucosal iga antibodies against flu have a lower immune response to the seasonal laiv. 2. the secondary objective is to determine whether the nasal wash viral neutralization data predicts laiv immunization failures.

Eligibility criteria:
inclusion criteria: * medically eligible healthy men and women between the ages of 20 to 49 years old. exclusion criteria: * a medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system. * a history of guillain-barré syndrome that occurred after receiving influenza vaccine * currently pregnant * have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components * have had flu within the current flu season. * have had a flu vaccine within the current flu season. * have close contact with someone whose immune system is so weak they require care in a protected environment (such as bone marrow transplant unit).

Keywords: influenza influenza vaccines vaccines, attenuated immunity, mucosal