Kornimate/medical-research-clean huggingface dataset:
vr-3d movie-based education

Conditions: mHealth

Summary: atrial fibrillation (af), which is the most common cardiac arrhythmia in adults, is associated with a high risk of stroke and other thromboembolic complications. the usage of oral anticoagulation (oac) may prevent the incidence of the thromboembolic events in the majority of patients. the current guidelines for the management of af patients highlight the important role of patients' education, since the clinical benefit from oac treatment may be achieved by the effective cooperation between patients and physicians. it has been suggested, that compliance may be increased by the novel e-solutions introduced into the daily clinical practice. due to the improvement in advanced technologies, the virtual reality (vr) three-dimensional (3d) movie stands for a future alternative in e-medicine. the aim of the oculus study was to examine whether the 3d movie-based knowledge transfer is effective in teaching patients about the consequences of af and pharmacological possibilities in reducing the risk of stroke.

the oculus is a prospective, single centre study. the study will include hospitalized patients, who are over 18 years old. the only exclusion criteria of the study is the previously diagnosed dementia. the study is based on the questionnaire designed by the authors of the study, enclosing questions about sex, age, education, current job, af history and knowledge about consequences of af and the possibility of stroke prevention due to the oac therapy. subsequently, the brief vr-3d will be shown using the oculus glasses and a smartphone. the movie's plot informs about the risk of stroke and importance of the oac therapy to prevent the incidence of the thromboembolic complications of af. consequently, patients will be asked several questions, including what was the movie about, whether af can affect patient's life in a negative way, is it possible to reduce the risk of stroke and by what kind of drugs. similar questions will be asked to the patients immediately after the movie, one week and one year later, via the telephone follow-up.

Eligibility criteria:
inclusion criteria: * \>18 years old * signed written informed consent exclusion criteria: * previously diagnosed dementia

Keywords: atrial fibrillation oral anticoagulantion stroke prevention education e-medicine
phase i study of lfa102 in patients with prolactin receptor-positive castration-resistant prostate cancer or prolactin receptor-positive metastatic breast cancer

Conditions: Castration-resistant Prostate Cancer; Metastatic Breast Cancer; Uterine Leiomyoma

Summary: the purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (mtd) or recommended phase ii dose (rp2d), characterize the safety, tolerability and pharmacokinetics profile. once the mtd has been established and/or a rp2d chosen, the study will enroll patients into the expansion portion of the study.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma 2. detectable metastases by bone scan, ct-scan, or mri. 3. presence of prolactin receptor in primary or metastatic tumor (dose escalation only) 4. suitable venous access for blood sampling exclusion criteria: 1. prior treatment with any anti-prolactin receptor antibody 2. major surgery within 28 days before study treatment 3. patients who have received radiotherapy ≤ 2 weeks prior to starting study drug 4. prior anaphylactic or other severe infusion reaction to antibody formulations other protocol-defined inclusion/exclusion criteria may apply

Keywords: prostate cancer, breast cancer, prolactin, prolactin receptor uterine leiomyoma
intraoperative tissue identification by analyzing surgical smoke

Conditions: Breast Cancer

Summary: surginose is a single-center, non-randomized feasibility study aiming to evaluate the feasibility of intraoperative tissue analysis using differential mobility of surgical smoke generated with electrocautery. patients receive standard-of-care breast conserving surgery.

the increasing number of breast cancer survivors and their longevity has emphasized the importance of aesthetic and functional outcomes of cancer surgery and increased pressure for the surgical treatment to achieve negative margins with minimal removal of healthy tissue. surgical smoke has been successfully utilized in tissue identification in laboratory conditions by using a system based on differential mobility spectrometry (dms) that could provide a seamless margin assessment method. in this study, a dms-based tissue smoke analysis system will be used intraoperatively in 20 breast cancer surgeries to assess its feasibility in tissue identification. the effect of the system on complications and duration of surgeries is also studied. the surgeries are recorded with a head-worn camera system for visual annotation of the operated tissue types to enable classification of the measurement files by supervised learning.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary malignancy of the breast exclusion criteria: -
study to assess long-term effectiveness of zomacton® and treatment adherence in patients with growth hormone deficiency or ullrich-turner syndrome

Conditions: Growth Disorders

Summary: assessment of long-term effectiveness of zomacton in treatment of growth hormone deficiency or growth retardation due to ullrich-turner syndrome and assessment of compliance and adherence, optionally with the aid of an electronic app or patient diary.


Eligibility criteria:
inclusion criteria: * pediatric patients (\< 18 years) with growth hormone deficiency or growth retardation due to ullrich-turner-syndrome * patients already receiving or who have been prescribed zomacton® de novo according to its german label; the decision to prescribe zomacton® was made independently from participation and prior to enrollment in this study. * patient and their parents (or legal representatives) who are willing and able to provide signed informed consent for use of their personal data. exclusion criteria: * participation in an interventional clinical study within the last 30 days prior to baseline visit or during the follow-up period
does mednav, a medical navigation system, aid non-technical and technical skills in the simulated obstetric emergency?

Conditions: Postpartum Hemorrhage,

Summary: it is well known that medical errors account for a large amount of patient harm within the hospital setting. this is a significant problem within the emergency context. a system that acts as a prompt, guide and scribe for the obstetric emergency has been developed called 'mednav'. mednav is a navigation device for the management of medical emergencies; developed at chelsea and westminster hospital since 2010. this is a device which acts similar to a satellite navigation devices in the automobile industry navigating you from a to b, mednav navigates the clinician from the unwell patient to the well patient.

potential participants will be identified by those attending mandatory training/teaching. 2 weeks before their mandatory training they will be emailed with the study information leaflet and a link to a video which explains how to use mednav. on the morning of the mandatory training/teaching they will be approached by the practice development midwife/chief or principle investigator who will give them a copy of the consent form and again the study information leaflet and show the mednav video. eligibility criteria will be checked and the study explained, before taking written informed consent. participants will personally sign and date the consent form, before any study specific procedures are performed. once the team is decided, the investigators will then randomise them to use of mednav or no mednav, the participants will then undertake a simulated management of post partum haemorrhage which will be recorded for later review. faculty will record the timing of completion of key technical skills. a team of 8 assessors will review these simulated scenario recordings. assessors will complete validated questionnaires to assess teamwork. assessors will be asked to complete a technical skills list, showing timing and completion of various technical aspects of managing post partum haemorrhage. the end of the study will be when the required sample size has been recruited or significance found on interim data analysis.

Eligibility criteria:
inclusion criteria: * staff undertaking mandatory training at chelsea and westminster hospital exclusion criteria: * non consenting.

Keywords: inventions simulation training postpartum haemorrhage non technical skills teamwork crew resource management, healthcare
assessing open access audio

Conditions: Hypertension; Diabetes

Summary: the medical encounter can be overwhelming in term of the amount of information discussed, its technical nature, and the anxiety it can generate. easy access to a secure audio recording from any internet enabled device is an available low cost technology that allows patients to "revisit the visit" either alone or sharing with caretakers and family. it has been introduced and tested outside the va with evidence that it increases patient recall and understanding and may even improve physician performance. little is known, however, about whether and to what extent these effects lead to better outcomes, such as improved treatment plan adherence and chronic disease self-management. this study is a randomized controlled trial designed ascertain whether easy access to audio recordings of the medical visit improves patients perception that they understand and can manage their own care, and leads to a variety of improved outcomes, such as better blood pressure and diabetes control, and fewer emergency department visits and hospitalizations.

the study aims to assess (1) the impact of an open access audio (oaa) program on two behaviors (patient activation, treatment plan adherence), and two chronic condition measures (glycosylated hemoglobin, blood pressure); (2) the impact of open access audio on provider communication and on their attention to patient contextual factors (i.e. individual veteran's needs and circumstances relevant to planning effective care); and (3) patient, provider, and leadership perceptions of the extent to which the program is safe, not burdensome, and worthwhile at both the start and at two years into the program. a secondary analysis will descriptively measure the effect size of oaa on ed visits and hospital admissions.

Eligibility criteria:
inclusion criteria: * all patients with scheduled appointments at the participating sites: primary care and diabetes clinics at jesse brown va medical center and the louis stokes cleveland va medical center exclusion criteria: * none
registry of translarna (ataluren) in nonsense mutation duchenne muscular dystrophy (nmdmd)

Conditions: Muscular Dystrophy, Duchenne

Summary: this study is being performed as a post-approval safety study (pass), per the pharmacovigilance risk assessment committee (prac) of the european medicines agency (ema), to gather data on translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.

this is a multicenter, observational study of participants receiving translarna based on inclusion of their data in a registry. this study is intended to enroll 360 participants across \~50 care centers in europe and other regions over a period of \~ 2 years. the study population will include participants who are receiving usual care treatment with commercial supply of translarna (or receiving care within a named participant early access program) and who provide consent. participants will be followed for at least 5 years from their date of enrollment. safety and efficacy data will be collected in conjunction with routine visits conducted as per usual care. although there are no protocol-mandated procedures, it is expected that physicians and other caregivers will follow published treatment guidelines and standards of care.

Eligibility criteria:
inclusion criteria: * receiving or will be receiving usual care treatment with commercial supply of translarna (or receiving care within a named participant early access program) * willing to provide written informed consent to allow the study data collection procedures (either by the participant or through authorisation by a legal guardian) exclusion criteria: * participants who are receiving ataluren or placebo in a blinded, randomized clinical trial, or ataluren in any other ataluren clinical trial or cohort early access program that prevents participation in this study
effective strategies for dementia care

Conditions: Dementia; Cognitive Impairment

Summary: the purpose of this study is to determine whether the interventions of snoezelen, structured reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term care residents with dementia.

design: cluster-randomized controlled trial with 20 nursing homes in saxony and saxony-anhalt (germany).

Eligibility criteria:
inclusion criteria: * dementia * informed consent by legal guardian * mmse ≤ 24 exclusion criteria: * korsakoff's syndrome * age ≤ 55 years * cognitive impairment other cause than dementia

Keywords: dementia snoezelen structured reminiscence therapy 10-minutes activation apathy
ct and radiologist rct

Conditions: Hernia

Summary: the use of computed tomography (ct) imaging is rapidly increasing in healthcare. despite physicians' growing reliance on radiological assessments, however, the reliability and accuracy of reads are highly variable. inconsistencies may result from multiple factors. the researchers hypothesize that the presence and quality of clinical information will affect radiologist's assessment of ct scans for the presence/absence of a ventral hernia.


Eligibility criteria:
participants are radiologists at lbj hospital.
transcutaneous pulse oximetry brain monitoring study (us)

Conditions: Acute Brain Injury

Summary: this is a study of adult patients with a severe and sudden brain injury who have a drain placed in their brain to measure pressure. the purpose of the study is to monitor the pressure in the brain using a monitor placed on the forehead, and compare this to a drain placed in the brain.

the device is a non-invasive brain pulse oximeter. it uses red and near-infrared light and provides a signal which represents the change in blood volume associated with each heartbeat. the brain signal allows a number of clinically important end-points to be determined, including brain blood flow, oxygen and pressure levels. the t-pot (us) study will be undertaken in patients that require invasive brain monitoring. the primary aim of the study is to assess the accuracy of the brain pulse oximeter compared with the traditional invasive intracranial pressure (icp) monitoring.

Eligibility criteria:
inclusion criteria: * 1. adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring as part of standard medical care * 2. adult brain-injured patients who have undergone external ventricular drain insertion for cerebrospinal fluid drainage and invasive intracranial pressure monitoring that have concomitant continuous electroencephalography (eeg) monitoring as part of standard medical care exclusion criteria: * 1. inability to obtain the brain pulse oximeter signal from at least one brain hemisphere due to interface issue such as severe agitation, head dressing, severe skin or bone trauma, or skull removal preventing brain pulse detection for the initial monitoring session. a. note: if unable to obtain brain pulse oximeter signal for subsequent monitoring sessions, the only the recordings that were obtained will be used for analysis * 2. hemodynamically unstable patients (defined as increasing vasopressors requirements) * 3. patients with unstable mechanical ventilation support defined as increasing fractional inspired oxygen (fio2) requirements
safety and efficacy of allo-316 in subjects with advanced or metastatic clear cell renal cell carcinoma

Conditions: Advanced/Metastatic Clear Cell Renal Cell Carcinoma

Summary: this is a phase 1 dose escalation study following a 3+3 study design. the purpose of the traverse study is to assess the safety, efficacy, and cell kinetics of allo-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and allo-647 to define a phase 2 dose.


Eligibility criteria:
inclusion criteria: * histologically confirmed renal cell carcinoma with a predominant clear cell component. * must have received a checkpoint inhibitor and a vegf inhibitor in the advanced and/or metastatic setting. * at least one measurable lesion as defined by recist version 1.1 * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. * absence of donor (product)-specific anti-hla antibodies (dsa). * adequate hematological, renal, liver, pulmonary, and cardiac functions. exclusion criteria: * central nervous system (cns) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression. * clinically significant cns dysfunction. * any other active malignancy within 3 years prior to enrollment. * prior treatment with anti-cd70 therapies. * current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy. * prior treatment with anti-cd52 monoclonal antibody in the past 12 months. * patients unwilling to participate in the extended safety monitoring period.

Keywords: car t cell therapy allogeneic cell therapy cellular immuno-therapy allocar t allo-316 allo-647 ccrcc clear cell renal cell carcinoma
communication strategy to promote hpv vaccination in pharmacies: promote study

Conditions: Human Papillomavirus Infection

Summary: this trial investigates how a communication strategy works in increasing human papillomavirus (hpv) vaccines in community pharmacies among adolescents. although pharmacies are vaccine providers, low vaccination rates are persistent as a result of low awareness of pharmacy services and poor engagement by pharmacy staff with adolescents about vaccines. the purpose of this study is to test a communication strategy that identifies vaccine-eligible children and teaches pharmacy staff how to effectively communicate with them about hpv vaccination in order to increase hpv vaccination rates.

outline: aim 1: participants participate in a semi-structured interview in-person or via phone over 90 minutes about barriers/facilitators of hpv vaccination in pharmacies. aim 2: participants provide feedback on survey questions via cognitive testing. pharmacy staff complete an online survey over 10-15 minutes to assess the acceptability, appropriateness, and feasibility of providing hpv vaccination to children aged 9-17 in their pharmacies. pharmacy staff then attend two, 60-minute vaccine communication training sessions, consisting of identifying vaccine-eligible children and recommending hpv and other vaccines. pharmacy staff employ the new communication strategy in their pharmacy up to 6 months, and then complete an online survey over 10-15 minutes. pharmacies of which the pharmacy staff participants work undergo an environmental scan to characterize the pharmacy's environment, vaccination workflow, and team dynamics. additionally, pharmacy audits will be conducted from the pharmacy electronic records to assess adoption of hpv vaccination, and the impact of the communication strategy on adoption of other adolescent vaccines (e.g., tetanus, diphtheria, acellular pertussis; meningococcal conjugate; influenza).

Eligibility criteria:
inclusion criteria: * aim 1 (parents/guardians): individuals with children between the ages of 9-17 in their care who are english speakers, live in washington state, and have access to a telephone or computer with internet access (up to 12 parents) * aim 1 (pharmacy staff): employed at a western washington bartell drugs pharmacy sites and have access to a telephone or computer with internet access * aim 2: pharmacy staff employed at up to four independent pharmacies in western washington state who speak english and have access to a computer with internet access exclusion criteria: * aim 1 (parents/guardians): those who object to having their interview audio recorded * aim 1 and aim 2 (pharmacy staff): floaters/per diem. those who object to having their interview audio recorded
study comparing two alternatives of antiretroviral therapy as post-exposure prophylaxis to hiv-1: tenofovir + emtricitabine + lopinavir/ritonavir versus tenofovir + emtricitabine + raltegravir (ral-pep)

Conditions: HIV Infection

Summary: as a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. this is known as post-exposure prophylaxis (pep). although there are different recommendations, almost every guideline recommend using 3 drugs as pep both in usa and europe. toxicity is one of the main limitations of pep. side effects during pep are very usual, are attributed mainly to pi and are the main reasons for poor adherence or lost of follow-up. a current standard regimen is azt+3tc (combivir®) or tenofovir+emtricitabine (truvada®) plus the pi lopinavir/r. toxicity associated with this regimens are high (31-85% of cases),with a high tolerability, a integrase inhibitor (raltegravir)could be an adequate drug for pep.


Eligibility criteria:
inclusion criteria: * potentially sexual exposition to hiv exclusion criteria: * pregnancy * source case with antiretroviral resistances * any treatment contraindicated with the drugs of study

Keywords: hiv infection postexposure prophylaxis
fmri-based neurofeedback to relieve drug-resistant auditory hallucinations

Conditions: Schizophrenia; Hallucinations, Auditory; Hallucinations, Visual

Summary: the intrude trial aims at assessing the efficacy of an fmri-based neurofeedback procedure on drug-resistant auditory hallucinations. hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fmri multivariate decoder. based on this progress, we can track patients' hallucinatory status using real-time fmri. we will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity. we will refer to a double-blind randomized placebo-controlled design. a total of 86 patients will be enrolled and equally split in an active neurofeedback group (n=43) and a sham group (n=43), matched for sex, age and panss scores. each patient will benefit from 4 runs of either active or sham neurofeedback. the primary outcome measure will be the mean decrease of ahrs scores relative to baseline, and at 1 month post-treatment. we expect significant clinical benefits from fmri-based neurofeedback on drug-resistant hallucinations compared with the sham group.


Eligibility criteria:
inclusion criteria: * schizophrenia (according to the dsm-5 classification) * frequent auditory hallucinations (saps item #1 ≥ 4) * stable medication for at least 30 days * absence of chronic neurological disorder (including seizure) * able to provide free written consent to participate in the research exclusion criteria: * pregnancy * contraindication to mri scan * claustrophobia * no social insurance

Keywords: schizophrenia hallucinations drug-resistance functional mri neurofeedback machine-learning.