Kornimate/medical-research-clean huggingface dataset:
sars-cov-2 igg and igm serologic assays

Conditions: Covid19

Summary: the primary objective is to assess and validate the ability of the beckman coulter access covid-19 igg and igm assays to detect immunity in covid-19 patients in the henry ford hospital health system.

overview: the design validation strategy for this study is to validate the detection of covid-19 antibodies in subjects at henry ford health system (hfhs) who test negative or positive with rt-pcr for sars-cov-2 using a fully automated system. this is a study of the immune response of subjects who have recovered from covid-19 infection. methods: there are now commercial testing products from major invitro diagnostic diagnostics companies that appear to have been developed with significantly greater test performance in mind. hfhs (hfhs) intends to make this testing available in the near future after a rigorous verification of analytical performance. this verification will be done in collaboration a with select and proven ivd partner. all hfhs patients \> 18 years of age who were evaluated and who have covid-19 pcr test results will have their medical records studies and a left-over specimen tested for validation purposes. this validation study will begin may 15, 2020 through november 15, 2020. impact: ivd manufacturers must rely on test specimens from suppliers (typically hospitals and reference laboratories) and attempt to replicate the test performance that will be achieved in the actual medical testing environment. in fact, samples collected and provided to vendors are usually at the convenience of the supplying institution. data on the real-world performance of covid-19 antibody tests derived from this study will have significant implications for patients and health systems, including patient disposition, risk prediction, return to work decisions, health system operations and more. furthermore, assessment of immunity in patients with minimal or symptom free infections will provide rich knowledge to assess if certain patients need further risk mitigations (masks, distancing) and which may be safely return to more normal activities.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age; covid-19 by rt-pcr sars-cov-2 assay. (phase i) exclusion criteria: * subjects who tested for covid-19, but have no available serum specimen.
midete - microrna levels under denosumab and teriparatide therapy in postmenopausal osteoporosis

Conditions: Postmenopausal Osteoporosis; Diabetes Type 2

Summary: the aim of this study is the quantitative determination of bone-specific micrornas in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy.

primarily the influence of the therapeutic treatment on the microrna concentration in the serum (treatment-response) and the relation between microrna serum levels and changes of the bone mineral density will be investigated. these data will help to examine the use of micrornas as novel diagnostic biomarkers for the diagnosis of osteoporosis and targeted therapeutic treatment of patients.

Eligibility criteria:
inclusion criteria: * postmenopausal women * age 60-80 years * t-score according to dxa: \<-2.5 * indication for osteoporosis therapy according to international guidelines exclusion criteria: * diabetes mellitus type 1 * renal insufficiency iii-v ° * cirrhosis hepatis (child b or higher) * chronic alcohol abuse * rheumatic disease (ra, spa, sle) * malignancies (\<5 years) * eating disorder (anorexia nervosa, bulimia) * bone-specific pretreatment (dmab, tptd, strontium ranelate, serms) bisphosphonate treatment is allowed
thrombophilia and thyroid autoimmunity in implantation failure and recurrent miscarriage

Conditions: Thrombophilia, Thyroid Autoimmunity

Summary: this study was designed to evaluate the incidence of both, inherited and adquired thrombophilia, and thyroid autoinmunity in unknown infertility (ui), implantation failure (if) and recurrent miscarriage (rm). to focus on these particular disorders and to rule out another potential confounding variables, 4 particular groups of women were created. only young women (\< 38 years old), patients whose previous preimplantation genetic screening (pgs) cycles displayed an acceptable rate of aneploidies, and women without organic uterine abnormality, autoimmune disease or endocrine disorder were included in the study.


Eligibility criteria:
inclusion criteria: 1. the control group included 32 oocyte donors, 18-35 years old, white caucasian, with normal karyotype, no miscarriages, and previous healthy live born infants without pregnancy complications. 2. the ui group consisted of 31 couples with \> 1 year infertility , \< 38 years of age, normal ovarian function, normal hysterosalpingography and transvaginal ultrasound scan of the uterus and ovaries, normal karyotype in both parents, and normozoospermia. 3. the if group included 26 couples with 3.9±1.1 ivf failures with embryo transfer of at least 2 good quality embryos. they were \ 5 mill/ml.they also had a pgs cycle with ≥ 60% of normal embryos. 4. the group of women with rm (n = 30) had 3.2±1.3 (range: 2-9) previous miscarriages. they were \ 5 mill/ml. only 6 women had 2 miscarriages (20%) and the remaining 24 women at least 3. they also had a pgs cycle with ≥ 60% of normal embryos.
efficacy and safety of a sore throat lozenge containing lidocaine and cetylpyridinium chloride in patients with sore throat due to a common cold.

Conditions: Sore Throat Due to a Common Cold

Summary: this study will compare the efficacy and safety of a single dose of a lidocaine 8 mg + cetylpyridimium chloride (cpc) 2 mg lozenge with a single dose of a lidocaine 1 mg + cpc 2 mg lozenge in the treatment of sore throat due to a common cold.


Eligibility criteria:
inclusion criteria: * patients with sore throat due to an upper respiratory tract infection, with recent onset (within 48 hours) * sore throat of at least moderate pain intensity exclusion criteria: * - history of hypersensitivity to any of the study drugs and listed excipients or to drugs of similar chemical classes * evidence of mouth breathing or severe coughing * evidence of overt oropharyngeal bacterial or fungal infection or evidence of lower respirator tract infection * severe renal, liver or cardiac impairment * severe lung disease

Keywords: sore throat, upper respiratory tract infection, lozenge with lidocaine and cetylpyridinium chloride.
the predictors of hemorrhagic transformation subtypes in acute embolic stroke patients

Conditions: Ischemic Stroke; Alteplase Adverse Reaction

Summary: the investigators evaluated the impact of af on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

investigators conducted a prospective cohort study between july 2021 and july 2023. they screened 1550 patients who presented with ais and received alteplase and included 716 ais patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset. the investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase. the study consisted of two distinct groups. the first group consisted of 454 patients who did not experience hemorrhagic infarction, while the second group comprised 262 patients who experienced hemorrhagic infarction. the investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors different types of af were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.

Eligibility criteria:
inclusion criteria: * the investigators enrolled individuals of both genders, aged between 18 and 75, * all patients had acute first-ever embolic ischemic stroke and were eligible for thrombolysis. * all patients had atrial fibrillation exclusion criteria: * the investigators excluded patients who had alteplase contraindications * the investigators excluded patients who did not receive the total dose of alteplase for any reason. * the investigators excluded patients who had a known history of persistent or recurrent cns pathology (e.g., epilepsy, meningioma, multiple sclerosis) * the investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or mri brain findings. * the investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks. * the investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest.
ivermectin-azithromycin-cholecalciferol (ivazcol) combination therapy for covid-19

Conditions: COVID

Summary: as the world faces covid-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. some drugs are being examined for the recent evidence on its effects on viral replication and inflammation, one is azithromycin, used to treat a wide variety of bacterial infections, ivermectin, an anti-parasitic drug and the other is cholecalciferol to increase serum concentration of 25-hydroxyvitamin d.

the aim of the study is to assess the efficacy of ivermectin-azithromycin-cholecalciferol combination in covid-19 in early stages of the disease with outpatient management. enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 30 cases of covid-19 will be enrolled into the trial with a 3:1 proportion, divided into two groups. first group with confirmed cases of covid-19 shall be treated with ivermectin (6mg once daily in day 0,1,7 and 8) plus azithromycin (500mg once daily for 4 days) plus cholecalciferol (400 iu twice daily for 30 days) in an outpatient regimen. the second group with confirmed cases of covid-19 who refused treatment were shall be allocated as the control group for monitoring. test for virus at day 1 and 14 from beginning of trial drug started for the outpatient regimen. clinical symptoms, oxygen saturation and oxygenation index will be monitored every day of the trial.

Eligibility criteria:
inclusion criteria: * confirmed infection of sars-cov2 virus * mild covid-19 * symptoms of respiratory illness * cough * fever (t \>38 °c) exclusion criteria: * allergy to any of the drugs treatment
zd6474 phase iia dose finding multicentre study

Conditions: Non Small Cell Lung Carcinoma

Summary: to assess the objective response rates (by recist) to zd6474 100, 200 and 300 mg/day respectively


Eligibility criteria:
inclusion criteria: * provision of written informed consent. * life expectancy of 12 weeks or longer. exclusion criteria: * pregnancy, breast feeding or female patients wishing to become pregnant. * treatment with a non-approved or investigational drug within 30 days before enrolment

Keywords: nsclc non small cell lung cancer
efficacy of telemonitoring on cpap treatment compliance in obstructive sleep apnea (osa) patients

Conditions: Sleep Apnea Syndrome

Summary: the purpose of this study is to compare the effectiveness of telemonitoring versus standard follow-up on cpap treatment compliance in obstructive sleep apnea syndrome (osas).

obstructive sleep apnea (osa) is defined by the presence of repetitive episodes of upper airways collapse during sleep, leading to nocturnal hypoxemia, sleep fragmentation and daytime sleepiness. when untreated, osa is a risk factor for arterial hypertension , cardiovascular and cerebrovascular diseases, road accidents and a worse quality of life. the application of a continuous positive airways pressure (cpap) represents the first line therapy in patients with moderate to severe osa. cpap treatment improves daytime sleepiness and oxygen saturation , reduces cardiovascular risk, ameliorates neurobehavioral performance, improves quality of life and reduces road accidents. despite its demonstrated efficacy, cpap effectiveness is significantly limited by poor adherence. a closer follow up could improve cpap adherence but it would take up more work and additional costs for sleep units. so on that account, the investigators propose a study to demonstrate that automatic home treatment monitoring of patients with osa is a cost-effectiveness alternative approach to patient's management. moreover, the investigators believe that telemonitoring could improve cpap compliance and patient's satisfaction and reduce follow-up costs. methods: prospective and randomized study during three months. patients diagnosed as osa in st. maria's hospital (sleep unit) and requiring cpap treatment, will be randomized into two groups differing in cpap compliance monitoring and management . group 1 standard care patients will be fitted with a mask and given a cpap and instructed on how to use the device. patients will follow the standard treatment management. all patients will be visited at 1 month at sleep unit. patients will be checked about progress and adherence to therapy and any problems with their machine. information will be downloaded from their machines (cpap adherence, applied cpap pressure, mask leak, and residual respiratory events...). group 2 telemonitoring patients will be fitted with a mask and given a cpap. each cpap device will be provided with a modem sending daily compliance information (cpap adherence, cpap pressure, mask leak, and residual respiratory events) to a web database. patients of both 2 groups will be finally visited at 3 months at sleep unit.

Eligibility criteria:
inclusion criteria: * men and women over 18 years old * diagnosed as osa and requiring cpap treatment * written informed consent form signed. exclusion criteria: * patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders) * severe heart failure * severe chronic pathology associated * psychiatric disorder * periodic leg movements * pregnancy * other dyssomnias or parasomnias * patients already treated with cpap

Keywords: cpap compliance telemonitoring standard management cost effectiveness
effects of real vs. soundless acoustic stimulation during deep sleep on brain activity, memory, and blood biomarkers in older adults (60-85) with mild memory impairment

Conditions: Cognitive Decline; Alzheimer Disease; Subjective Cognitive Decline (SCD); Mild Cognitive Impairment (MCI); Cognitive Impairment, Mild

Summary: this study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (sws). sws is important for memory and clearing waste from the brain. poor sws can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia. the investigators are testing whether phase-locked auditory stimulation (plas) can improve sws in people at a mild stage of cognitive impairment. plas uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. the investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting. in this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) plas across two different 4-week periods. memory will be tested using engaging "serious games." before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. the investigators expect that plas will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline. if successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.


Eligibility criteria:
inclusion criteria: * written informed consent * age between 60 and 85 years * cognitive impairment (subjective and/or moca between 23-26) * native german speakers or comparably fluent * normal or corrected-to-normal vision. * intact hearing * a close cohabitant (partner/sibling) should be present to support participants in using study materials/devices. exclusion criteria: * insomnia assessed by the regensburg insomnia scale (ris; crönlein et al., 2013) * restless leg syndrome assessed by questions concerning typical symptoms. * sleep apnoea assessed by the berlin questionnaire (bq; netzer et al., 1999) * severely irregular sleep patterns assessed by the ris and the pittsburgh sleep quality index (psqi; buysse et al., 1989) * symptoms of depression (geriatric depression scale (gds; yesavage et al., 1982) ≥ 5) * history of untreated severe neurological and psychiatric diseases * alcohol or substance abuse * use of medication acting on the central nervous system

Keywords: sleep dementia prevention phase-locked auditory stimulation blood-based biomarkers home longitudinal electroneurophysiology eeg memory cognition serious games old age human
the development of a patient reported outcomes measure committed to the watch-and-wait program for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study to develop an international tool that can be used to assess burden of disease in patients enrolled in the w\&w program for rectal cancer

the watch-and-wait (w\&w) strategy in rectal cancer is a organ-sparing treatment option, where patients with a clinical complete response (ccr) after neoadjuvant chemo(radio)therapy, do not undergo surgery but instead follow a strict follow-up scheme. the goal of the w\&w strategy is to preserve the rectum and thereby retain functional outcomes (fo) (e.g. gastro-intestinal, urinary, sexual) and improve quality of life (qol). patient reported outcome measures (proms) reflect the patients' evaluation of their symptoms, fo and qol. in the w\&w program various proms (e.g. eortc-cr29/c30, lars, sf-36) are used to assess the these different outcomes. however, most of the proms used are developed and validated in a surgical patient group. so the relevance and usefulness of these proms may be limited in w\&w patients. for use in clinical practice, a short prom would support follow-up care as it provides a clear overview of the problems w\&w patients experience. this paper describes the protocol for the development of an international tool that can be used to assess burden of disease in patients enrolled in the w\&w program for rectal cancer. we will use the delphi methodology to reach consensus about items that should be included in the novel tool. the aim of this tool is to improve direct patient care during the entire watch-and-wait program.

Eligibility criteria:
inclusion criteria: * patients have to be treated with neoadjuvant (chemo)radiotherapy * patients are included into the watch-and-wait program * experts involved in the treatment of rectal cancer * experts involved in the watch-and-wait program exclusion criteria: * regrowth of disease

Keywords: watch-and-wait organ-preserving treatment method functional outcomes patient reported outcome measures quality of life delphi exercise
prescription event monitoring in patients with benign prostatic hyperplasia (bph)

Conditions: Prostatic Hyperplasia

Summary: study to evaluate the safety profile of secotex® in the improvement of the symptoms of benign prostatic hyperplasia in real clinical practice


Eligibility criteria:
inclusion criteria: * patients of any age with a diagnosis of symptomatic benign prostatic hyperplasia (bph) * patients with symptoms, that according to physician require medical treatment to improve quality of life * patients could be naive to treatment or could be on treatment with other drugs but have not responded adequately to treatment exclusion criteria: * patients with known hypersensitivity to tamsulosin, or any other component of the product * patients with a history of orthostatic hypotension or severe liver failure
prisons evaluation of a one-stop-shop intervention

Conditions: Hepatitis C

Summary: a prospective historically controlled study to assess the effect of an intervention integrating point-of-care hepatitis c (hcv) rna testing, non-invasive liver fibrosis assessment, fast-tracked direct-acting antiviral (daa) prescription, and linkage to hepatitis care (a 'one-stop-shop' intervention), on the proportion of participants initiating daa therapy among people who are recently incarcerated within reception correctional centre(s) in australia.


Eligibility criteria:
inclusion criteria 1. has provided written, informed consent to participate; 2. is male and ≥18 years of age on enrolment; 3. has been incarcerated within the last six weeks; 4. is hcv daa treatment naïve; 5. is able and willing to provide informed consent and abide by the requirements of the study. for hcv rna positive participants commencing treatment: 6. if hiv-1 infected must also meet the following criteria: 1. hiv infection documented by any licensed rapid hiv test or hiv enzyme or chemiluminescence immunoassay (e/cia) test kit at any time prior to study entry (baseline) and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid hiv and/or e/cia, or by hiv-1 p24 antigen, or plasma hiv-1 rna viral load; and 2. be on hiv antiretroviral therapy (art) for at least 4 weeks prior to study entry using an art regimen that is allowable with the selected daa regimen as determined by the current pi and the liverpool drug interaction website (http://www.hiv-druginteractions.org/ ) exclusion criteria for hcv rna positive participants commencing treatment, the subject will be excluded if they have: 1. untreated hiv co-infection; 2. chronic hbv co-infection; 3. any clinically significant condition, history or concomitant medication known to contraindicate daa therapy or would not be suitable for management within a prison-based treatment setting; 4. is unable to gain an accurate reading on the fibroscan or the result is invalid; 5. known clinical or laboratory evidence of cirrhosis, or cirrhosis documented on fibro-elastography (\> 12.5 kpa).

Keywords: hepatitis c public health health service prisons