Kornimate/medical-research-clean huggingface dataset:
factors affecting prep adherence

Conditions: HIV Infection

Summary: the purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). this new questionnaire is called interactive questionnaire system (iqs). in this study, the iqs will be tested on hiv-negative young men who have sex with men (ymsm) who are taking prep as part of another study, either atn 110 or atn 113.

among men who have sex with men (msm) in the u.s., human immunodeficiency virus (hiv) incidence has remained highest in those less than 30 years of age, demonstrating the need for new ways to prevent hiv in young men who have sex with men (ymsm). pre-exposure prophylaxis or prep is the use of a daily medication to prevent hiv infection. in order for prep to work the pills must be taken, so adherence is a very important part of prep. efforts to accurately assess adherence to prep have been hindered because participants do not always accurately report adherence and the flawed methods that have been used to measure adherence. in previous studies it has been shown that participants over-report adherence when compared to drug concentration levels in blood. although drug-levels can be used to monitor adherence, the cost can be prohibitive and specimens may be difficult to collect in real-time. this means that better and more accurate assessments of prep adherence from self-reports are needed in order for prep to achieve wide-spread use. this longitudinal pilot sub-study of atn 110 and atn 113 (project prepare - an open label demonstration project and phase ii safety study of pre-exposure prophylaxis use among young men who have sex with men (ymsm) in the united states) aims to assess how structural (physical settings) and partnership factors affect adherence of ymsm to prep. this study will compare levels of adherence reported in the interactive questionnaire system (iqs) to those collected in atn 110 or atn 113 by audio computer assisted self interview (acasi), wisepill, and drug concentration levels in blood and hair. the iqs will be administered at study entry and week 24 visits. prep, emtricitabine/tenofovir disoproxil fumarate (truvada®), will be administered as part of the atn 110 and atn 113 protocols. study drug will not be administered as part of this study, atn 123.

Eligibility criteria:
inclusion criteria: * concurrent enrollment in atn 110 or atn 113 and prescribed ftc/tdf (emtricitabine/tenofovir disoproxil fumarate (truvada®)) for prep; * ability to understand written and spoken english; and * willing and able to provide written informed consent. exclusion criteria: * appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent; and * intoxicated or under the influence of alcohol or other substances at the time of consent.

Keywords: prep hiv prevention
chemoprevention of cancer in the lower female genital tract: the antineoplastic activity of the fungicide ciclopirox.

Conditions: Vulvar Cancer

Summary: the purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.


Eligibility criteria:
inclusion criteria: * patients between the ages 18 and 75 years. * patients may be carriers of the human immunodeficiency virus (hiv). * patients must have been diagnosed with precancerous lesion(s) of the vulva by tissue sampling (biopsy-proven vulvar intraepithelial neoplasia grade ii or iii) * patients must be able to come to university hospital for their initial appointment in gynecologic oncology clinic, and for the eight follow-up visits in that clinic required by the protocol. exclusion criteria: * pregnant or patients who are breast feeding a baby. * patients who have been diagnosed with a vaginal yeast infection. * patients who have undergone prior surgery for precancerous lesion(s) of the vulva.

Keywords: vulva
prognostic significance of ctdna in hl

Conditions: Prognostic Cancer Model

Summary: specific somatic mutations using ctdna will be analyzed in predefined subgroups of chl (e.g., age \<60 and ≥ 60 years, ebv). these mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. circulating tumor dna will be correlated with the extent of tumor mass and chemo/radiotherapy.

samples of plasma from peripheral blood will be taken for investigational ctdna examination during the specific timepoints: at diagnosis, after 2 cycles of initial chemotherapy, at the end of chemotherapy, 3 months after radiotherapy, at the diagnosis of the first relapse, after salvage chemotherapy before asct, 3 months after asct, at the diagnosis of second relapse and every 3 months during brentuximab vedotin treatment or during nivolumab treatment until progression. the buccal swab for germline dna extraction will be performed at the time of enrollment into the study. samples of peripheral blood for ebv-dna analysis will be obtained from the ebv-positive chl patients to measure ebv load at the same time-points as ctdna. microdissected hrs cells from fresh frozen biopsies at the diagnosis and at the relapse will be used for tumor cells next generation sequencing.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years with newly histologically confirmed classical hodgkin lymphoma (chl) will be enrolled * signing the informed consent exclusion criteria: * pacients without signing the informed consent

Keywords: hodgkin lymphoma circulating tumor dna next generation sequencing
mri repository for acute stroke clinical and research applications

Conditions: Stroke, Acute

Summary: stroke is one of the leading causes of death and long-term disability. a major unresolved problem in mri-based stroke assessment is to relate image features to brain function in a way that can properly guide stratification for treatment and rehabilitation. this requires extracting meaningful and reproducible models of brain function from stroke images, a daunting task severely hindered by the great variability of lesion frequency and pattern. large datasets are imperative to uncover possible lesion-function relationships. in this project the investigators will create a large database of acute strokes mris. the investigators will retrospectively archive an estimated 3,000 mris of patients with acute stroke, acquired at the johns hopkins hospital, 2009-2019. this dataset will include 1.5 and 3 tesla scans, diverse protocols and sequences (e.g., diffusion and perfusion weighted images (dwi/b0, pwi), t1, t2, flair, susceptibility weighted images), with typical clinical low voxel resolution (4-7 mm3). lesions will be initially delineated on dwi/b0, the most informative mri sequence for acute stroke. after anonymization and defacing, two trained evaluators will perform the manual lesion segmentation. two expert neuroradiologists will create consensual structured radiological reports with information about stroke type and location according to different criteria (e.g., 34 brain structures and 11 vascular territories). the investigators will also archive structured information from discharge (demographics, laboratory, and neurological evaluation of patients, including nih stroke scale and modified rankin scale, mrs), as well as the 90-days follow-up mrs.


Eligibility criteria:
inclusion criteria: * patients admitted at hopkins stroke center with the diagnosis of acute brain stroke exclusion criteria: * not performed mri
diagnosing intensive care unit (icu) acquired weakness

Conditions: ICU Acquired Weakness

Summary: the goal of this study is to develop a non-invasive test to diagnose intensive care unit (icu) acquired weakness that can be administered to both responsive and non-responsive patients. study participation will involve the measurement of muscle fatigue during a single 30 minute session. skeletal muscle will be stimulated with an fda approved clinical electrical stimulator and accelerations will be passively recorded with an accelerometer.

the primary purpose of this study is to develop a procedure to identify intensive care unit (icu) acquired weakness. this condition occurs in a subset of people admitted into the icu, and is associated with a 30% increased risk of death before discharge from the icu. there are currently major limitations in the ability to diagnose icu acquired weakness, making it difficult to study. the goal is to develop a non-invasive test that can be administered to both responsive and non-responsive patients. the current proposal will focus on replicating the results of previous research using motion detecting accelerometers to measure fatigue in human skeletal muscles. this study is designed to test out the procedures in patients who have been transferred from the icu to a lower level of care so that follow-on studies can be designed to help mitigate this condition in the icu.

Eligibility criteria:
inclusion criteria: * patients transferred from the icu to a lower level of care within the past 7 days * mechanical ventilation for greater than 7 days while in the icu * ability to understand english and provide written consent exclusion criteria: * vulnerable populations including: patients who are pregnant or prisoners * patients who are unable to understand english or provide written consent

Keywords: biofeedback muscular disorders neuromuscular disorders rehabilitation
selinexor for treatment of light chain amyloidosis with relapsed/refractory disease

Conditions: Amyloid; Amyloidosis; AL Amyloidosis

Summary: the purpose of this study is to test the safety and efficacy of selinexor and dexamethasone and see what effects it has on al amyloidosis.


Eligibility criteria:
inclusion criteria: * diagnosis of primary al amyloidosis * relapsed and/or refractory al amyloidosis * measurable disease * male or female patients 18 years or older * able to give voluntary written consent * eastern cooperative oncology group performance status and/or other performance status 0, 1, or 2. * absolute neutrophil count (anc) ≥ 1,000/mm3 and platelet count ≥ 75,000/mm3. * total bilirubin ≤ 1.5 × the upper limit of the normal range (uln). * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 × uln. * calculated creatinine clearance ≥ 30 ml/min exclusion criteria: * non-al amyloidosis * clinically overt myeloma * prior exposure to selinexor * clinically significant cardiac disease * severe obstructive airway disease * female patients who are lactating or have a positive serum pregnancy test during the screening period * planned high-dose chemotherapy and autologous stem cell transplantation within 6, 28-day treatment cycles after starting on treatment * failure to have fully recovered (ie, ≤ grade 1 toxicity) from the reversible effects of prior chemotherapy. * major surgery within 14 days before enrollment. * radiotherapy within 14 days before enrollment. * infection requiring systemic intravenous antibiotic therapy or other serious infection within 14 days before study enrollment. systemic treatment, within 14 days before the first dose, with strong cyp3a inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, see appendix 11.7), or use of ginkgo biloba or st. john's wort. * positive for human immunodeficiency virus (hiv), hepatitis b, and hepatitis c * serious medical or psychiatric illness * gi disease or gi procedure that could interfere with the oral absorption or tolerance including difficulty swallowing * diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * participation in another clinical trials involving investigational agents within 30 days of starting this trial * peripheral neuropathy (grade 2 with pain or grade 3 or higher).
seaweed-derived rhamnan sulfate and vascular function

Conditions: Cardiovascular Diseases

Summary: the primary aim of the proposed investigation is to examine the hypothesis that a relatively short period of rhamnan sulfate supplementation would improve key markers of vascular dysfunction in middle-aged and older adults with at least one risk factors for cardiovascular disease.


Eligibility criteria:
inclusion criteria: * at least one risk factor for cardiovascular disease (e.g., dyslipidemia, hypertension, obesity, impaired fasting glucose) * a bmi of \<40 kg/m2 exclusion criteria: * gastrointestinal disorders and/or renal disease * pregnancy or lactation * strenuous physical activity (\>3 times/week) * alcohol abuse
a study to compare the effectiveness of two anti-hiv drug combinations

Conditions: HIV Infections

Summary: the purpose of this study is to compare two different anti-hiv drug combinations, one that contains nelfinavir (nfv) and one that does not. the best dosing schedule for indinavir (idv) also will be studied.

patients are stratified by screening plasma viral rna results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. group 1 receives idv 3 times daily plus d4t/3tc twice daily. group 2 receives idv/nfv/d4t/3tc twice daily. patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. at each clinic visit, blood samples are taken to evaluate cd4 cell count and plasma hiv rna levels.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv positive. * have a viral load (level of hiv in your blood) of at least 10,000 copies/ml within 45 days of study entry. * have a cd4 cell count of at least 100 cells/mm3 within 45 days of study entry. * have a normal chest x-ray. * have never taken protease inhibitors or 3tc. * are 16 years of age or older. * agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms). exclusion criteria you will not be eligible for this study if you: * have an active opportunistic (aids-related) infection or cancer. * have certain types of kaposi's sarcoma. * have hepatitis. * have chronic diarrhea. * have a history of certain medical conditions. * are allergic to any of the study medications. * are taking certain medications. * are pregnant or breast-feeding.

Keywords: drug therapy, combination hiv protease inhibitors lamivudine indinavir reverse transcriptase inhibitors anti-hiv agents nelfinavir
accidental hypothermia in drowning-related ohca

Conditions: Hypothermia, Accidental; Hypothermia Due to Cold Environment; Drowning; Out-Of-Hospital Cardiac Arrest

Summary: this study aims to report mortality and neurological outcome 180 days after drowning incident in patients with accidental hypothermia vs normothermia following drowning-related ohca in denmark during a six-year period from 2016-2021.

the incidence of accidental hypothermia in patients with out-of-hospital cardiac arrest (ohca) due to drowning is prevalent. accidental hypothermia is known to decrease oxygen consumption and hypoxic brain damage in patients with ohca, but may result from prolonged submersion times, which is shown to increase drowning mortality and morbidity. however, many case reports present extraordinary instances of hypothermic patients with drowning-related ohca surviving with a good neurological outcome despite prolonged submersion times. a larger, retrospective study is warranted to accurately investigate the role of accidental hypothermia in patients with drowning-related ohca. this study is a nationwide, retrospective cohort study with 180-days follow-up from 2016-2021 comparing survival and neurological outcome 180 days after drowning incident in normothermic (≥35c) vs hypothermic (\ 3). secondary outcomes include hospital length of stay (continuous), intensive care unit admission (binary) and length of stay (continuous), need for ecls (binary) and duration (continuous), need for mechanical ventilation (binary) and duration (continuous), survival to hospital discharge, and 30-day survival. the investigators expect to provide evidence on the role of accidental hypothermia in drowning-related ohca to support evidence-based guidelines and improve clinical decision-making in the future.

Eligibility criteria:
inclusion criteria - drowning persons with: * ohca registered in the dcar from 2016-2021. * an in-hospital temperature measurement (using any probe) within 6 hours after hospital admission. exclusion criteria - drowning persons will be excluded if: * they have obvious signs of irreversible death (decapitation, decomposition, post-mortem lividity, post-mortem rigidity). * they are declared dead on scene. * they have a valid do-not-attempt-resuscitation order or other code status orders limiting life-sustaining therapies. * they do not have a valid civil registration number. * they do not have a valid in-hospital temperature measurement (any probe within 6 hours after hospital admission).
comparison of conventional versus 3-d printed complete denture regarding retention, accuracy, elctromyographic activity and patient satisfaction.

Conditions: Edentulous Mouth

Summary: analyzing and comparing the retention, accuracy, emg and patient satisfaction of maxillary complete denture base fabricated by conventional and rapid prototyping techniques.


Eligibility criteria:
elligibility criteria: inclusion criteria: * completely edentulous patients were selected to have their ridges covered with firm, thick and compressible mucosa * all patients accepting prosthodontic treatment by an removable denture. exclusion criteria: * tmj disorder. * limited mouth opening or mandibular movement * muscle spasm or tenderness * mandibular deviation
real life effectiveness of easyhaler (orion)

Conditions: Asthma

Summary: the aim of this study is to compare the clinical effectiveness and cost-effectiveness of the easyhaler® (eh) device and other dpi devices commonly used in the uk in a uk primary care asthma population of patients aged 6 to 80 years.

a recent observational study by price et al carried out using the uk's general practice research database (cprd) to compare asthma-related outcomes for different inhaled corticosteroid (ics) inhaler devices, using easyhaler and dry powder inhalers (dpis).

Eligibility criteria:
inclusion criteria: * patients must also meet the following inclusion criteria: * (1) aged: 6-80 years - stratified 6-11 years; 12-60 years; ≥61 years to allow paediatrics and adolescent / adult sub analyses; and to allow for the exclusion of elderly (aged 61+) smokers and ex-smokers if required. * (2) on-going asthma therapy: ≥2 prescriptions for asthma during the outcome period (i.e. ≥1 prescription (for any asthma therapy) in addition to the prescription for ics at ipd (initiation / step-up/ switch). * (3) evidence of active asthma: 1. initiation - a diagnostic code for asthma 2. step-up / switch - ≥2 prescriptions for asthma (at least one of which is for ics) at different points in time during the baseline year plus a diagnostic code for asthma. * (4) have at least one year of up-to-standard (uts) baseline data and at least one year of uts outcome data (following the ipd). exclusion criteria: * patients will be excluded from the analysis if they have: * (1) had a copd read code at any time; and/or * (2) had any chronic respiratory disease, except asthma, at any time; and/or * (3) patients on maintenance oral steroids during baseline year; and/or * (4) multiple ics prescriptions at ipd.

Keywords: gprd effectiveness cost-effectiveness easyhaler primary care dpi
perinatal outcome after premature rupture of membranes

Conditions: Fetal Membranes; Premature Rupture

Summary: premature rupture of membranes is an important cause of neonatal morbidity and mortality, mainly because of the complications associated with this pathology (oligohydramnios, cord compression or prolapse, infection). when rupture of the membranes occur the risk of cord compression increases but there is little evidence regarding this complication and amniotic fluid volume. the investigator's focus are the perinatal outcomes according to amniotic fluid volume (\ 5).


Eligibility criteria:
inclusion criteria: * gestational age between 24-34 weeks. * confirmed diagnosis of premature rupture of membranes. exclusion criteria: * twin pregnancies. * obstetric pathologies that require immediate termination of pregnancy (severe preeclampsia, abruptio placenta, cord prolapse). * termination of pregnancy (whatever the reason) before complete corticoid treatment. * incomplete recollection of all data required for analysis.

Keywords: fetal membranes, premature rupture cesarean section perinatal mortality neonatal sepsis amniotic fluid volume
bpd saturation targeting

Conditions: Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity; Chronic Lung Disease

Summary: bronchopulmonary dysplasia (bpd), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.this study evaluates the use of supplemental oxygen to manage infants with established bpd. participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.

bronchopulmonary dysplasia is diagnosed only in babies who are born prematurely, and affects about half of extremely preterm infants. the incidence of bpd has increased over time. it is most commonly defined as oxygen dependence at 36 weeks postmenstrual age (pma). infants with bpd face more than doubled odds of death after 36 weeks pma or disability at 5 years compared to preterm infants without bpd. bpd is associated with abnormal lung function throughout childhood and significantly increases health care costs. cognitive and respiratory outcomes are closely linked throughout the life course; thus, optimal long--term management of bpd during infancy may ultimately improve cognitive outcomes of this high--risk population. supplemental oxygen is a lifesaving therapy for premature infants; yet, there is limited evidence about the safety or efficacy of using supplemental oxygen to target higher versus lower oxygen saturations in infants with established bpd. infants between the ages of 34-44 weeks post-menstrual age with moderate or severe bpd will be randomly assigned to higher or lower oxygen saturation target ranges. the study intervention will begin in the hospital and will continue at home until 6 months corrected age. when infants are discharged with supplemental oxygen, this will be titrated according to a study algorithm in order to ensure that the target saturations are maintained throughout the study period.

Eligibility criteria:
inclusion criteria: * pre-term males or females infants born at \<30 0/7 weeks gestation at birth * current age 34 0/7 to 43 6/7 weeks postmenstrual age * diagnosis of moderate or severe bronchopulmonary dysplasia based on the nih consensus definition * infant has never been discharged to home from the hospital exclusion criteria: * congenital anomaly or oncologic process likely to affect growth or respiratory status * hemoglobinopathy or other blood disorder likely to affect oxygen saturations * contraindication to nasal cannula use (for example, severe nasal septal breakdown). * pulmonary hypertension requiring pharmacotherapy at the time of screening/enrollment. * tracheostomy * intubated during entire eligibility period

Keywords: bpd prematurity supplemental oxygen oximetry infants