Kornimate/medical-research-clean huggingface dataset:
pediatric seizure movement bed alarm

Conditions: Seizures; Sleep; Epilepsy

Summary: nocturnal seizure and sudden unexplained death in epilepsy patients (sudep) are major concerns for parents and creates anxiety and poor sleep conditions for many families dealing with epilepsy. an accurate and reliable system for alerting parents to ongoing seizure activity could make a substantial impact in quality of life and possibly reduce the mortality of epilepsy. no previous studies in the pediatric population have been performed to evaluate this type of monitoring for seizure activity. this is one of the most common questions parents ask in clinic, "are there any alarms that can tell me when my child is having a seizure at night?" currently the answer is no. this study has the capability to give us data that may change this answer to yes.

for parents of children with epilepsy, seizures occurring in sleep are a major concern. this frequently leads to many nights of lost sleep for parents and also to unfavorable sleeping arrangements, especially for older children and adolescents. sudden unexplained death in epilepsy patients (sudep) is also a major concern for both parents and neurology practitioners. patients with epilepsy have increased risk of sudden unexplained death compared to the rest of the population. the risk of sudden death in epilepsy is estimated at 24 times the risk of the general population. specific risk factors for sudden death have been evaluated and the most frequently reported risk factors include: nocturnal seizures, being in bed, and history of generalized tonic -clonic seizures. interestingly, one case-control study observed a decreased risk of sudep with nighttime monitoring or supervision which raises the possibility that some cases of sudep may be preventable if another person is able to give assistance. this finding may indicate that some of these deaths may be preventable if a caregiver could be alerted to seizure activity. use of "baby monitors", apnea monitors and pulse oximeters to monitor their children at night has been attempted by families; however, these devices are not specific to seizure activity and in the case of apnea monitors and pulse oximeters have frequent false alarms leading to further anxiety and sleep disturbance for families. therefore, there is a need for a product that can reliably detect seizure activity without such frequent false positives as to interfere with sleep and functional life.

Eligibility criteria:
inclusion criteria: * epilepsy exclusion criteria: * non-epileptic

Keywords: nocturnal epilepsy
expanded access protocol (eap) for participants receiving idecabtagene vicleucel that is nonconforming for commercial release

Conditions: Multiple Myeloma

Summary: this study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. this is an expanded access protocol (eap) to be conducted at risk evaluation and mitigation strategies (rems) qualified sites approved for commercial administration of idecabtagene vicleucel and where the eap is authorized to be conducted for use of nonconforming idecabtagene vicleucel. non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the expanded access protocol setting.


Eligibility criteria:
inclusion criteria: * had a participant-specific batch of idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria * remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant * clinically stable exclusion criteria: * has a hypersensitivity to the active substance or to any of the excipients * no experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming idecabtagene vicleucel (ide-cel) * has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the expanded access protocol based on the investigator's judgement other protocol-defined inclusion/exclusion criteria apply

Keywords: bb2121 multiple myeloma expanded access idecabtagene vicleucel nonconforming car t eap pre-approval access
achieving equity in genomic testing for breast cancer through partner-led strategies and policies

Conditions: Breast Cancer

Summary: the purpose of this study is to identify the barriers, and the extent of said barriers, to genomic testing for breast cancer patients among low-income and minority populations, particularly throughout northern california. the investigators have created a survey that is available online for any patient with cancer to fill out voluntarily regarding their experiences to date. the survey is available at: https://stanforduniversity.qualtrics.com/jfe/form/sv_7velf8oeswcb3be

the study has two main data-collecting phases. in phase 1, the investigators will engage multilevel stakeholders to respond to a survey assessing experience with and perceptions of genomic testing and its accessibility for patients with breast cancer in california. in phase 2, selected and interested survey participants who voluntarily provide their contact information on the survey will be asked to participate in an in-depth 1:1 semi-structured interview to explore disparities in genomic testing for breast cancer more closely. the investigators will then utilize their findings from both phases to present aggregate findings to an expert panel and community advisory board and work together to develop policy recommendations. the policy recommendations will then be presented to policy makers, with the aim of identifying sustainable solutions that address breast cancer treatment and outcome disparities throughout northern california.

Eligibility criteria:
inclusion criteria: * the patients must be 18 years or older. * patients who opt in to complete the survey. * patients must have the capacity to verbally consent for the interview. exclusion criteria: * patients who under the age of 18 years old.

Keywords: genomic testing precision breast cancer care precision medicine
autoantibodies and systemic sclerosis

Conditions: Understand Pathogenicity of SSc-specific Antibodies in SSc and the Effect of Antibody Blockade in Vitro

Summary: established in vitro assays, combined with state-of-the-art multi-omics approaches and innovative in vitro experimental models, will gain insights into the mechanistic bases underlying systemic sclerosis (ss) pathogenesis and will dissect the consequences of treatment with efgartigimod on functional and phenotypic cell behaviors. healthy microvascular endothelial cells, fibroblasts and monocytes will be challenged with serum and autoantibodies prior to or upon treatment with efgartigimod in order to assess both the prevention and the recovery capacity of the fcr blocker. the putative modulatory effect of efgartigimod on vascular remodeling, endothelial-to-mesenchymal transition, fibroblast-to-myofibroblasts transition and monocyte behavior will be evaluated in in-vitro consolidated assays. integrated omics analyses will support and complement the in vitro findings by unveiling potential prognostic signatures and by identifying specific treatment-related profiles that might guide the modulation of the drug usage in order to maximize its beneficial effects.


Eligibility criteria:
inclusion criteria: * positivity of autoantibodies exclusion criteria: * pregnant
heart rate informed changes in care for non-communicating patients

Conditions: Autism Spectrum Disorder; Intellectual Disability; Communication, Nonverbal

Summary: the overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. the trial will 1) evaluate how hr can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (hr)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through hr affects the quality of communication between patient and caregiver.

detailed protocol to be published as journal article with reference to clinicaltrials.gov-registration. preprint available: https://osf.io/gan42

Eligibility criteria:
inclusion criteria: * between 5 and 70 years of age at the time of data collection * autism spectrum disorder as evaluated by clinical psychologist * communication difficulties * living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school/day-care at least five days a week. * written informed consent is obtained from the subjects' legal representative. exclusion criteria: - having any autoimmune disorder or any type of cancer with ongoing chemotherapy.

Keywords: heart rate autistic disorder intellectual disability social interaction caregivers developmental disabilities communication biomarkers pain
validation of a mirna panel to optimize treatment response in patients with metastatic pancreatic cancer (mirpanc 2)

Conditions: Pancreatic Cancer; Metastasis; Epigenetic

Summary: this study is being conducted to better understand how pancreatic cancer behaves during treatment and how we can improve methods for monitoring disease progression. the research aims to determine whether small molecules present in the blood, called mirnas, can help doctors assess whether the treatment is working or needs adjustment. with this, we hope to make cancer monitoring less invasive and more precise, allowing patients to receive more personalized and effective treatments.

pancreatic cancer, particularly pancreatic ductal adenocarcinoma (pdac), has an extremely poor prognosis, with a 5-year survival rate of less than 3% for advanced stages. in 2020, brazil saw about 11,893 deaths from this condition, with incidence rates expected to rise. the standard treatment for metastatic pdac is the folfirinox regimen, but its response is variable and its effectiveness is limited, with few advancements in personalized therapy and response prediction. this research aims to develop and validate a panel of serum-based mirna biomarkers using qpcr and large-scale sequencing (ngs) to evaluate treatment response in metastatic pdac patients. the goal is to identify mirna expression patterns that predict the effectiveness of folfirinox and assist in personalizing treatment based on individual responses. the study will use liquid biopsy to collect blood samples and analyze circulating mirnas, enabling early detection of treatment responses and disease progression. this will allow for precise therapeutic adjustments and alternative treatment options based on the patient's profile. the innovative approach combines liquid biopsy with mirna analysis as a low-cost, effective tool for monitoring and personalizing treatment. using qpcr, a more affordable method than ngs and microarrays, enhances clinical feasibility. the research is highly relevant to the brazilian unified health system (sus), as an accessible mirna panel could optimize resource use, reduce costs of ineffective treatments, and improve care quality and outcomes, aligning with sus's goals for precise and accessible healthcare.

Eligibility criteria:
inclusion criteria: * patients diagnosed with metastatic pdac; * patients who will start treatment with folfirinox; * 18 years or older; * who agree to participate in the study by signing the informed consent form; exclusion criteria: * patients who have previously undergone chemotherapy, whether neoadjuvant, adjuvant, or any prior first-line treatment; * patients who do not meet the minimum criteria to receive the proposed regimen, such as those with hyperbilirubinemia, those who are not candidates due to age or performance status deterioration;

Keywords: pancreatic cancer mirna treatment response epigenetic folfirinox
ibci optimization for veterans with paralysis

Conditions: Spinal Cord Injury; Amyotrophic Lateral Sclerosis; Brain Stem Infarctions; Locked-in Syndrome; Muscular Dystrophy

Summary: va research has been advancing a high-performance brain-computer interface (bci) to improve independence for veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis, spinal cord injury or stoke. in this project, the investigators enhance deep learning neural network decoders and multi-state gesture decoding for increased accuracy and reliability and deploy them on a battery-powered mobile bci device for independent use of computers and touch-enabled mobile devices at home. the accuracy and usability of the mobile ibci will be evaluated with participants already enrolled separately in the investigational clinical trial of the braingate neural interface.

after va irb approval, this va rr\&d study will engage participants in the braingate clinical trial (ide, sponsor-investigator lr hochberg). this study does not create a new clinical trial or modify the existing clinical trial as already listed on clinicaltrials.gov this project builds on a custom, mobile neural signal processing device with exceptional processing and low power characteristics, which has been developed through previous va rr\&d funded research. this project takes advantage of the exceptional processing system, previously developed and validated, to create and quantify advanced neural decoding algorithms that show promise (in preclinical studies) for improving the accuracy and reliability of neural decoding - but that are likely too computationally demanding to be viable on existing real-time bci systems. decoding methods will include magnitude kinematic decoding with recursive neural networks and high-dimensional discrete gesture decoding. computational methods to be evaluated include latent space methods and stable manifolds to improve day-to-day reliability of high performance and high-dimensional orthogonalization approaches to improve the independence of kinematic and gesture decoding.

Eligibility criteria:
inclusion criteria: * inclusion criteria are extensive and are determined by the associated braingate ide(clinicaltrials.gov # nct00912041) * informally, participants will be tetraplegic or anarthric with little or no functional use of the arms and legs exclusion criteria: * exclusion criteria are extensive and are determined by the associated braingate ide(clinicaltrials.gov # nct00912041).
cardiopulmonary exercise test in peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: aim: to determine whether the lactate threshold during cpet is influenced by the presence of haemodynamically significant pad. assumption: correction of haemodynamically significant pad results in an increased lt, measured by cpet. design: prospective study population: thirty patients scheduled to undergo surgical or percutaneous treatment of iliofemoral arterial disease for intermittent claudication.

patients scheduled to undergo surgery or angioplasty of the iliofemoral segment for intermittent claudication will be screened for inclusion. consenting patients will undergo abi measurements and cpet before treatment and four weeks after treatment. study measures will be performed in the respiratory physiology laboratory at university hospital aintree. demographic and medical details will be recorded including gender, age, smoking history and pack years, medical history and treatment and bmi. a record will be made of patuients' latest full blood count which will be routinely available in all participants before the procedure. ankle-brachial index will be recorded. the subjects will undergo full cpet. this includes recording of baseline spirometry, full ecg monitoring throughout the test, measurement of ventilator parameters and recording of borg breathlessness and leg fatigue score every minute. at the end of the test the reason for cessation will be documented. the test will be incremental with a 10-20w ramp determined according to baseline mvv aiming for the subject to exercise for 10-12 minutes. the test will involve 3 minutes rest, 2 minutes free-pedal followed by continuous ramping until volition. recording will continue for 5 minutes recovery

Eligibility criteria:
inclusion criteria: * written informed consent, ability to perform a cpet on a cycle ergometer, intermittent claudication as presenting complaint, age ≥18, iliofemoral arterial disease exclusion criteria: * critical limb ischaemia, unwillingness to consent, previous amputation or other inability to perform cpet on a cycle ergometer, age \<18, absence of iliofemoral arterial disease, any standard cpet exclusion based on american thoracic society/european respiratory society guidelines, including severe arthritis or lower limb abnormality precluding exercise testing, severe hypertension at rest, unstable angina or acute coronary syndrome within the previous 6 weeks, terminal illness/advanced cancer or major psychiatric illness, including dementia, which precludes consent

Keywords: peripheral arterial disease, cardipulmonary exercise test
virtual reality relaxation for addiction inpatients

Conditions: Addiction

Summary: this trial examines the immediate session effect of virtual reality (vr) relaxation, when used at an addiction inpatient ward for adolescents.

past research has revealed that virtual reality nature environments can be used to induce relaxation, yet this type of intervention has not yet been evaluated in a clinical setting. this trial examines whether vr relaxation can be used as a digital equivalent of a (physical) comfort room at an an addiction inpatient ward for adolescents.

Eligibility criteria:
inclusion criteria: * patient at maria ungdom inpatient ward. * sufficient grasp of swedish to understand terms of study participation and intervention instructions. exclusion criteria: * self-reported stereoscopic vision or balance problems hindering vr experience. * self-reported history of repeated violent outbursts when using technology.

Keywords: virtual reality relaxation
a randomized-controlled trial to increase the uptake of larcs in cameroon

Conditions: Contraception; Contraception Behavior; Contraceptive Usage; Contraceptive Method Switching

Summary: cameroon exhibits a high and non-decreasing level of maternal mortality (roughly 600 per 100,000 live births), partially related to its relatively high total fertility rate (roughly 4.6). survey evidence furthermore suggests that a significant fraction of these pregnancies is unwanted or considered mistimed by the mother, especially among females aged 15-19. despite this, the rate of utilization of family planning (fp) is low: e.g. only 48% of sexually active unmarried women use any form of (modern) contraception, or mc, and even then, it is primarily condoms. the use of larcs (long-acting reversible contraceptives, i.e. the iud and implant) is less than 1% according to the most recent demographic health survey. the study investigators propose to use an integrated behavioral science approach to increase the take-up of both sarcs (short-acting reversible contraceptives, i.e. the pill and injectable) and especially larcs among reproductive-age females in cameroon, including adolescents who may be unmarried and/or nulliparous. in addition to decreasing maternal mortality and undesired pregnancies, indirect effects for the community will include: increased welfare from reduced side effects that arise due to current one-size-fits-all fp counseling; healthier children due to improved birth spacing; and increased human capital formation both for children and for young (often school-aged) potential mothers. the study investigators propose to conduct the study at hgopy for a duration of 12 months. the study investigators will provide tablets to each of five nurses that conduct fp counseling to participants at the hospital. the tablets contain a counseling "app" (or decision-support tool or a job-aid) that was jointly developed by professionals from hgopy, the world bank, and the ministry of health. the study investigators propose an individually-randomized experiment, where the participants will be offered randomly varying discounts for the modern contraceptive methods they wish to adopt. the study investigators also propose to experiment with certain aspects of the "app" to improve its effectiveness - both for the participant and for the nurse. more details on the experimental design are provided below.


Eligibility criteria:
inclusion criteria: * female * ages 10-49 * presenting at hgopy seeking fp counseling/services * hgopy clients referred to the family planning unit for consultation exclusion criteria: \* no exclusion criteria

Keywords: adolescent sexual and reproductive health, maternal mortality, teen pregnancy, larcs, family planning counseling
comparing misoprostol and oxytocin in unijecttm for postpartum hemorrhage (pph) prevention in mali

Conditions: Postpartum Hemorrhage

Summary: this is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 iu oxytocin delivered by unijecttm intramuscularly during the third stage of labor.

this study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in unijecttm for the prevention of pph and will help to identify the appropriate niche for both drugs.

Eligibility criteria:
inclusion criteria: * women delivering at home with a trained study provider who are able to provide informed consent exclusion criteria: * women with known contraindications to prostaglandins

Keywords: postpartum hemorrhage prevention misoprostol uniject oxytocin
prospective clinical trial of the hemopatch topic hemostatic in cardiac surgery

Conditions: Bleeding

Summary: a new topical hemostatic agent composed of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as nhs-peg) has been reported to be extremely effective, in addition to traditional means, in terminating bleeding during cardiac operations with control rates as high as 97,5%. the investigators compared such hemostatic agent (hemopatch; baxter inc, deerfield, il) with traditional optimized hemostasis routine. following sample size calculation, in a prospective randomized study design, 100 patients will be treated with hemopatch and 100 patients will receive traditional optimized hemostasis routine (comparison group). to make the two cohorts as comparable as possible enrollment will be restricted to moderately bleeding vascular anastomosis of dacron grafts to ascending aorta or moderately bleeding transversal aortotomy. study endpoints are the following: rate of successful intraoperative hemostasis (identified by cessation of bleeding in less than 3 minutes from application) and time required for hemostasis; overall postoperative bleeding; rate of transfusion of blood products; rate of surgical revision for bleeding; postoperative morbidity; and intensive care unit stay.


Eligibility criteria:
inclusion criteria: * surgery on ascending aorta with dacron graft or transverse aortotomy * moderate bleeding exclusion criteria: * none

Keywords: bleeding hemostatic