Kornimate/medical-research-clean huggingface dataset:
sleep-sensitive seizure risk assessment with wearable eegs

Conditions: Epilepsy Intractable

Summary: epilepsy, a prevalent neurological disorder, affects 40% of patients with uncontrolled seizures despite medications. sleep disturbance exacerbates epilepsy, and vice versa, but existing literature suffers from limitations. studies conducted in hospital settings provide only brief observation periods and fail to capture the natural sleep environment. wearable technology offers a promising solution, providing a nuanced understanding of the relationship between seizures and sleep. the dreem headband, an eeg-based wearable, is well-suited for such studies, offering ease of use and validated accuracy. this technology enables extended observation periods under stable medication conditions, essential for assessing the complex interplay between sleep and epilepsy. by elucidating the impact of sleep on seizures, the researchers seek to identify patient populations where sleep significantly influences seizure susceptibility, ultimately informing personalized epilepsy treatments.

the first aim of this study is to investigate how variations in sleep timing, duration, and structure influence seizure risk, particularly in individuals with sleep-sensitive seizures. the investigators will conduct longitudinal eeg assessments to analyze how changes in sleep features correlate with interictal epileptiform discharge rates and seizure occurrences over time. the second aim is to develop a sleep quality index that predicts individual risk for sleep-sensitive seizures, the sleep-sensitive epilepsy risk index (seri). this index aims to predict an individual's seizure risk associated with disrupted sleep, facilitating personalized and preventative patient care.

Eligibility criteria:
inclusion criteria: * age \> 18 years * at least 2 seizures per week based on clinical notes * patients where medications will stay stable over the study period * 40% of both spikes and spindles are identifiable on the dreem headband based on the screening night exclusion criteria: * cognitive impairment * psychiatric comorbidities which may influence sleep * no bedpartner/caregiver to observe seizures * low agreement (below 60%) between dreem's sleep scoring and manual scoring will be excluded from the study * apnea-hypopnea index of \> 10/h

Keywords: epilepsy sleep wearable eeg
psychophysical characterization and brain correlates of dentine hypersensitivity

Conditions: Dentine Hypersensitivity

Summary: up to date, devices capable of delivering controlled, calibrated, non-contact cold air stimuli in a mr environment are unavailable for quantitative sensory testing. this project therefore aimed at designing and constructing a novel mr-compatible, computer-controlled cold air stimulation device that produces air puffs in a broad flow and cold temperature range. by means of this device, detailed psychophysically testing and subsequent brain scanning of dentine hypersensitivity (dh) subjects will be possible to gain new insights about dh mechanisms.


Eligibility criteria:
inclusion criteria: * age and between 18 - 60 exclusion criteria: * caries * defective restorations * full crowns * orthodontic bands * bleeding on probing and periodontal pockets deeper than 3 mm * subjects with gross periodontal disease or treatment of periodontal disease in the past 12 months.
surgeons can avoid lasting pain through exercise literacy

Conditions: Neck Pain; Shoulder Pain

Summary: the physical demands of surgery are in many ways similar to those of high-performance athletes. no professional athlete would consider performing without careful attention to strengthening and physical preparedness, yet surgeons routinely place rigorous demands on their bodies without any training plan specific to their work demands. a series of exercises were developed to help stretch and strengthen the key core muscles to support surgeons during operating to prevent neck pain. this study hypothesizes that neck pain discomfort will decrease following an 8-week intervention program compared to baseline reported scores.

participant will be asked to fill out a series 5 questionnaires at beginning of the study, end of the 8-week intervention and 1 month later to determine how the exercise program affected their general health, neck pain, and function. 1. demographic information about their age, height, weight, sex, surgical experience, surgical frequency, level of pain, and exercise frequency and types. (21 items) 2. a questionnaire about neck pain (10 items) 3. a questionnaire about how pain interferes with their life (8 items) 4. a questionnaire about general health (10 items) 5. a questionnaire about how much the participant typically exercise. (4 items) all these questionnaires can be completed on a computer or tablet and the data will be stored on a secure site (redcap). this should be completed in approximately 20 minutes at each assessment. next participants will be instructed how to perform a series of 4 exercises described in the intervention every week the participant will be sent a 3-item questionnaire to report their level of pain, surgical burden, and exercise compliance for the week. there are only 3 multiple choice questions which should take approximately 1 minute to complete per week.

Eligibility criteria:
inclusion criteria: * must be an actively operating surgeon either faculty, fellow, or resident. * must report at least 4 out of 10 with pain at worst over the previous week at intake that is attributed to operating. exclusion criteria: * participants will be excluded if they have prior neck or upper back surgery within the last year. * if the participant has any other medical condition that would prevent the participant from performing shoulder and neck strengthening and stretching exercises.

Keywords: surgeon
a multicenter, phase 3 study of ibi343 monotherapy versus treatment of investigator's choice in subjects with previously treated, claudin (cldn) 18.2-positive, her2-negative, gastric or gastroesophageal junction adenocarcinoma

Conditions: Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Summary: this is a multicenter, randomized, open-label, phase 3 study of ibi343 monotherapy versus treatment of investigator's choice in subjects with previously treated claudin (cldn) 18.2-positive, her2-negative, locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma to compare the progression free survival (pfs) and overall survival (os)


Eligibility criteria:
inclusion criteria: 1. able and willing to sign a written informed consent form (icf) and to comply with protocol-specified visits and related procedures. 2. has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (g/gej ac). 3. has received and progressed on at least 2 lines of systemic therapy (anti-pd-(l)1 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). a prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. the subject has ≤ 4 prior lines of systemic therapy. 4. has histopathologically confirmed cldn18.2-positive disease. 5. is a man or woman of 18 years of age or older at the time of signing the icf. 6. has an eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. exclusion criteria: 1. has her2-positive (defined as immunohistochemistry \[ihc\] 3+, or ihc 2+ and positive by in situ hybridization) disease. 2. is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study. 3. has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s). 4. has received the last dose of an anti-cancer therapy (including traditional chinese medicine indicated for gastric cancer in the package insert, but excluding herbal prescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment. 5. plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed).
effect of open kinetic cke exercises with nes in patients with post-acl reconstruction surgery

Conditions: Anterior Cruciate Ligament Injuries

Summary: "anterior cruciate ligament (acl) reconstruction is a commonly performed surgical procedure for restoring knee stability in patients following acl injuries. despite surgical success, postoperative rehabilitation remains crucial for improving functional outcomes, addressing quadriceps strength deficits, and reducing recovery time.

this study investigates the combined impact of open kinetic chain (okc) knee extension exercises and neuromuscular electrical stimulation (nmes) on the functional recovery of post-acl reconstruction patients. this randomized clinical trial involves 58 patients, divided into two groups: an experimental group receiving okc knee extension exercises combined with nmes and a control group receiving okc exercises alone. functional outcomes, range of motion (rom), and patient-reported outcomes (pros) are assessed using validated tools.

Eligibility criteria:
inclusion criteria: * both genders aged 18-45 years * subjects who have undergone unilateral primary acl reconstruction surgery * subjects who are exactly 4 weeks post-surgery at the start of the study * subjects who received a hamstring tendon autograft or patellar tendon graft for acl reconstruction * subjects cleared by a physician to begin open kinetic chain exercises in their rehabilitation program * subjects who are generally healthy with no significant comorbidities that could interfere with rehabilitation * willingness to provide informed consent and commit to the entire duration of the study exclusion criteria: * presence of additional knee injuries (e.g., meniscal tears, collateral ligament injuries) that might affect rehabilitation * history of prior acl injury or reconstruction on the same knee * patients who underwent reconstruction of other ligaments along with the acl * presence of conditions (e.g., rheumatoid arthritis, osteoarthritis, uncontrolled diabetes) that could influence recovery * any significant injury or surgery to the opposite knee within the last six months * factors that indicate a high risk of non-compliance with the rehabilitation protocol, such as poor availability, or lack of commitment to follow the exercise regimen * conditions affecting neuromuscular control that could interfere with exercise performance or rehabilitation response
ono-5920/ym529 confirmatory study in involutional osteoporosis patients

Conditions: Osteoporosis; Bone Loss, Age-Related

Summary: this is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ono-5920/ym529 with its daily formulation.


Eligibility criteria:
inclusion criteria: * patients whose bone mineral density is \<70% of young adult mean (yam), or \<80% of yam who have fragile fracture history * patients can walk on his/her own * written informed consent has been obtained from the patient. exclusion criteria: * sequential osteoporosis patients or patients with other disorders showing low bone mass * patients with the findings that influence measurement of lumbar vertebral bone mineral density by the dxa method * patients who are unable to keep raising or standing for ≥30 min * patients with peptic ulcer * patients who have experienced anamnesis or gastrectomy (total extraction)

Keywords: ono-5920 ym529 bone mineral density minodronic acid
rapid poc gas diagnostics in the paediatric ed

Conditions: Streptococcal Pharyngitis

Summary: randomized trial evaluating effectiveness of rapid point-of-care molecular gas diagnostics as compared to standard culture-based techniques for the management of children aged 3-18 years of age presenting with sore throat to mcmaster children's hospital emergency department.


Eligibility criteria:
inclusion criteria: * all those presenting who have a throat swab ordered for gas testing exclusion criteria: * those who took antibiotics effective against gas within 72 h of ed presentation
the practice of providing palliative care in the situation of the covid-19 (coronavirus disease 2019) pandemic in czech republic

Conditions: Covid19; Distress, Emotional

Summary: pandemic of coronavirus sars-cov-2 (severe acute respiratory syndrome coronavirus 2) causing the disease covid-19 (coronavirus disease 2019) overwhelmed healthcare and brought new challenges and stressful situations.

in a short time, the capacities of intensive care units (icu) were filled in many countries and regions. due to the need for an excessive number of patients requiring intensive care, physicians and nurses who do not routinely provide care to critically ill patients or do not have the appropriate training (non-icu clinician) were involved in the care of covid-19 (coronavirus disease 2019) patients. in this context, icu directly dedicated to the care of patients with covid-19 ards (acute respiratory distress syndrome) were also opened. non-icu clinicians were more or less involved together with the standard icu staff in palliative care, including end-of-life decision (eold) making, even in a situation of limited scarce resources (equipment or personnel). new workplace and scope of work, which did not correspond to the standard activity or education, most likely led to an increased stress load. eold can also be one of the factors leading to increased stress levels. the aim of the project is to describe the practice of palliative care for patients with covid-19 in a situation of pandemic covid-19 and to identify factors leading to possible moral distress related with eold.

Eligibility criteria:
inclusion criteria: * healthcare providers (physicians and nurses) providing care to patients with covid-19 admitted at icu in period of covid-19 pandemic. exclusion criteria: * healthcare professionals who did not managed covid-19 patients admitted at the icu in situation of covid-19 pandemic in the period 2020/2021.

Keywords: palliative care compassionate care end-of-life decisions moral distress
risk stratification of rapid disease progression in children with crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study for children with a new diagnosis of crohn's disease is to identify biomarkers found in the blood or stool to help predict which children are at risk of developing complications.

it is estimated that between 15-20% of children with crohn's disease will develop complications that can require surgery within the first three years of diagnosis. the purpose of this study for children with a new diagnosis of crohn's disease is to identify biomarkers found in the blood or stool to help predict which children are at risk of developing complications. a total of 2000 children with newly-diagnosed crohn's disease will be enrolled within 30 days of diagnosis. up to 28 medical sites in the united states and canada will participate in the study.

Eligibility criteria:
inclusion criteria: * males and females younger than 17 years of age (before their 17th birthday). an upper limit of 17 years of age was selected as important inclusion criteria to maximize the number of potential subjects that would be diagnosed and followed by a pediatric gastroenterologist for at least 3 years. * confirmed or suspected diagnosis of crohn's disease based on standardized diagnostic criteria. the enrollment should occur within 30 days of diagnosis. * able to provide written informed consent or the ability to obtain written informed consent from the parents or patient's legal guardian in conjunction with youth assent. * consented to have specimens tested for genetics and immune responses. * access to follow-up data for a minimum of 36 months after diagnosis. * final eligibility will be determined by the health professionals conducting this clinical trial. exclusion criteria: * infectious colitis. * final eligibility will be determined by the health professionals conducting this clinical trial.

Keywords: crohn's disease inflammatory bowel disease
examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to epidural lipomatosis.

Conditions: Lipomatosis; Low Back Pain

Summary: the specific aims of this proposal are to: examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. the primary outcome will be improvement in vas score of combined back and leg pain at 6 weeks follow-up. secondary outcomes will include improvement in visual analog scale (vas) back pain scores, vas leg pain scores, and oswestry disability index (odi) , as well as scs complication rate. the specific aims of this proposal are to: examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. the primary outcome will be improvement in vas score of combined back and leg pain at 6 weeks follow-up. secondary outcomes will include improvement in vas back pain scores, vas leg pain scores, and oswestry disability index, as well as scs complication rate.


Eligibility criteria:
inclusion criteria: 1. - have chronic pain for \>3 months 2. age 18-65 years 3. have been scheduled to be implanted with the spinal cord stimulator due to epidural lipomatosis. 4. mri evidence of lumbar spinal stenosis with grade i-iii lumbar epidural lipomatosis and concordant history and physical examination exclusion criteria: * no evidence of lumbar epidural lipomatosis based on mri 2. presence of a pacemaker/icd (to avoid possible side-effects of electrical stimulation) 3. coagulopathy (either non-pharmacological or unable to discontinue anticoagulation due to underlying comorbidities as deemed by prescribing physician) 4. unable to follow commands or provide consent. 5. are not medically/psychologically stable 6. have clinical/emg documented motor dysfunction and have not been evaluated by spine surgeon. 7. inappropriate surgical candidates as determined by the individual implanting physician. 8. history of laminectomy/fusion in thoracic or lumbar spine.
biomarkers in samples from patients with follicular lymphoma treated with rituximab

Conditions: Lymphoma

Summary: rationale: studying the effects of rituximab in blood and tumor tissue samples from patients with cancer in the laboratory may help doctors learn more about the effects of rituximab on cancer cells. it may also help doctors identify biomarkers related to cancer. purpose: this research study is studying biomarkers in samples from patients with follicular lymphoma treated with rituximab.

objectives: * correlate immunoglobulin fc receptor (fcγr) polymorphisms with response, response duration, and time to resistance in samples from patients with follicular lymphoma (fl) treated with single-agent rituximab on ecog-e4402. * identify gene expression profiles that correlate with response, response duration, and time to rituximab resistance in these patients. * determine whether the fl microenvironment is predictive of initial response and duration of response to rituximab. outline: dna and rna from banked peripheral blood mononuclear cells (pbmcs) and formalin-fixed paraffin-embedded (ffpe) tumor samples are analyzed for immunoglobulin-receptor polymorphism, gene expression profile, and follicular lymphoma microenvironment by real-time pcr, microarray hybridization, and ihc. projected accrual: a total of 259 pbmc samples and 300 ffpe blocks will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosed with follicular lymphoma * treated on ecog-e4402 comprising 1 of 2 different rituximab-dose strategies * banked peripheral blood mononuclear cells (pbmcs) and formalin-fixed paraffin-embedded (ffpe) tumor samples available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iv grade 1 follicular lymphoma stage iv grade 2 follicular lymphoma
a study of tace combined with atezolizumab plus bevacizumab or tace alone in patients with untreated heaptocellular carcionma

Conditions: Hepatocellular Carcinoma

Summary: this study will evaluate the efficacy and safety of atezolizumab plus bevacizumab combined with on-demand tace compared to on-demand tace alone in participants with hepatocellular carcinoma who are at high risk of poorer outcome following tace treatment.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hcc by histology/ cytology or clinical criteria * eligible for tace treatment * no prior systemic therapy for hcc, especially immunotherapy * no prior locoregional therapy to the target lesion(s) * at least one measurable untreated lesion * ecog performance status of 0-1 * child-pugh class a exclusion criteria: * evidence of vp3/4 and hepatic vein tumor thrombus (hvtt) * evidence of extrahepatic spread (ehs) * being a candidate for curative treatments * any condition representing a contraindication to tace as determined by the investigators * active or history of autoimmune disease or immune deficiency * untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding * a prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment * evidence of bleeding diathesis or significant coagulopathy
effect of deproteinization on the shear bond strength and glue penetration in the enamel of orthodontic brackets

Conditions: Orthodontic Appliance Complication

Summary: the aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (sbs) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (sep) as a primary objective. as secondary objective a raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.


Eligibility criteria:
inclusion criteria: - all patient with orthodontic treatment involving bicupids extractions exclusion criteria: - patients with damaged teeth

Keywords: glue penetration orthodontic brackets self-etching bracket
natural history study of patients with vcp-related disease

Conditions: IBMPFD

Summary: a natural history study to understand the expected progression of disease in patients with confirmed mutations in the vcp gene over 1 year.

this is a single site, prospective natural history study to evaluate the utility of strength, functional, and patient reported outcomes in quantifying disease progression over 1 year in patients with mutations in the vcp gene. patients will complete a remote and onsite visits at baseline, a remote visit at 6 months, and then a final remote and onsite visit at 12 months. all strength, functional, and patient reported measures will be completed at each visit to assess reliability, consistency of results across testing environments, and sensitivity to change over time. additionally, patients may opt in to provide blood, serum, and urine samples for biobanking.

Eligibility criteria:
inclusion criteria: * genetically confirmed mutation in the vcp gene * age ≥18 years * willing and able to provide informed consent and follow all study procedures exclusion criteria: * participation in an interventional clinical trial * any concomitant illness or comorbid condition that would interfere with a patient's ability to complete study procedures safely at the discretion of the site pi.