Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety and efficacy of etrasimod in subjects with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to determine whether etrasimod is a safe and effective treatment for moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * participants with chronic atopic dermatitis, defined by hanifin and rajka criteria, that has been present for at least 1 year prior to the screening visit * participants with eczema area and severity index (easi) ≥ 12 at the screening visit and ≥ 16 at the baseline visit * participants with validated investigator's global assessment (viga) score ≥ 3 (on the 0 to 4 viga scale, in which 3 = moderate and 4 = severe) involvement at the screening and baseline visits exclusion criteria: * presence of skin comorbidities that would interfere with study assessments of the underlying disease.

Keywords: moderate-to-severe atopic dermatitis etrasimod apd334
trifocal intraocular lens (iol) aberrometry outcomes

Conditions: Cataract

Summary: the goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal iol implantation.


Eligibility criteria:
inclusion criteria: * able to consent to study and cataract surgery * visually significant cataract * potential post-operative visual acuity of 20/25 or better * age 18 years or older exclusion criteria: * ocular pathology contraindicated for trifocal iols including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss * irregular astigmatism * prior corneal refractive surgery

Keywords: trifocal lens trifocal intraocular lens aberrometry
staged kidney transplantation during combined heart/kidney transplantation

Conditions: Heart Failure; Chronic Kidney Disease; End-stage Kidney Disease

Summary: the primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart/kidney transplantation.

combined heart and kidney transplantation (h/ktx) is the treatment of choice for patients with concomitant heart failure and chronic- or end-stage kidney disease. h/ktx presents a logistical challenge, often involving multiple surgical teams and requiring extended operative time to perform both heart and kidney transplants. additionally, during heart transplantation, recipients require anticoagulation and multiple inotropes and vasopressors to support heart function early after implantation. while necessary, these may be detrimental to the newly implanted kidney allograft, potentially contributing to vasoconstriction, bleeding, hypotension, and worsening ischemia-reperfusion injury. unfortunately, delaying implantation leads to extended cold ischemic time which also may be detrimental to the graft. delayed graft function (dgf) of the kidney allograft is defined as the need for dialysis in the first seven days after transplantation and has been shown to be an important risk factor for graft loss following h/ktx. ultimately, h/ktx requires balancing recipient stability with cold ischemic time to optimize kidney graft function. new perfusion technology adds oxygenation to the perfusate of the kidney allograft, thereby resuscitating the organ during preservation and reducing ischemia-reperfusion injury. this study seeks to evaluate the safety and efficacy of planned delayed implantation to allow for improved recipient stability and coagulopathy, while using hypothermic oxygenated machine perfusion (hope) for kidney preservation.

Eligibility criteria:
inclusion criteria: * adult patients (18 years or older) undergoing combined heart and kidney transplantation at cedars-sinai medical center. exclusion criteria: * patients who undergo simultaneous heart/kidney transplantation in a single operative event due to medical necessity will be excluded. * patients with medical records flagged as "break-the-glass" or "research opt-out" within the center's electronic health record.

Keywords: combined heart and kidney transplant simultaneous heart and kidney transplant hypothermic oxygenated machine perfusion organ preservation
tolerability and pharmacokinetics of iloperidone in adolescent patients

Conditions: Safety and Tolerability of Iloperidone

Summary: tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication


Eligibility criteria:
inclusion criteria: * males or females 12-17 years of age. * in a stable housing situation with a guardian/parent who can encourage compliance with the study protocol. * with diagnosis of disorder requiring treatment with an antipsychotic agent. * having a children's global assessment of severity scale (cgas) of 41 or greater. * heart rate \ /= 50 beats per minute. exclusion criteria: * patients with mild, moderate or severe mental retardation (i.e., documented iq \<70), do not have the capacity to assent, cannot understand the informed consent, or participate fully in the assessments. * hospitalized due to suicidal ideation or suicidal behavior, history of suicidal ideation within 6 months prior to screening, history of suicidal behavior within 2 years prior to screening. * pregnant, females who can become pregnant and lactating females. * known hypersensitivity to iloperidone and to related drugs. * clinical conditions (neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological), which may pose significant risk to patients or impair reliable study participation. * clinically unstable cardiac disease, structural cardiac abnormalities, congential long qt syndrome, clinically significant ecg abnormalities at screening (pr interval \>240 ms, qtcf \>450 ms, qrs duration \>/= 100 ms) or arrhythmias. * syncope, near syncope, or palpitations. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: antipsychotic schizophrenia bipolar disorder iloperidone
dlcs for predicting neoadjuvant chemotherapy response

Conditions: Gastric Cancer; CT Images; Deep Learning; Neoadjuvant Chemotherapy; Tumor Regression Grade

Summary: the early noninvasive screening of patients suitable for neoadjuvant chemotherapy (nct) is essential for personalized treatment in locally advanced gastric cancer (lagc). the aim of this study was to develop and visualized a radio-clinical biomarker from pretreatment oversampled ct images to predict the response and prognosis to nct in lagc patients.


Eligibility criteria:
inclusion criteria: 1) patients with gc/egjc confirmed by pathological examination; 2) patients who underwent d2 lymphadenectomy; 3) patients who received at least two cycles of preoperative chemotherapy; 4) patients with negative resection margins; and 5) patients with complete ct image data and clinical data. exclusion criteria: 1) patients unable to undergo d2 radical gastrectomy after neoadjuvant therapy; and 2) patients with incomplete ct images and clinical data.
long-term follow-up of subjects treated with axo-aav-gm2 for tay-sachs or sandhoff disease

Conditions: GM2 Gangliosidosis; Tay Sachs Disease; Sandhoff Disease

Summary: this study is to continue long-term follow-up of patients who were previously treated with axo-aav-gm2 gene therapy as treatment for tay-sachs or sandhoff disease to follow the subjects through 5 years after their initial gene therapy treatment.

subjects will be contacted bi-annually for a total of five years following the administration of axo-aav-gm2 for the collection of clinical information, especially pertaining to de novo cancer, neurologic, rheumatologic, and hematologic/immunologic disorders. this will be done to comply with fda recommendations and nih guidelines for long-term follow-up for research involving gene therapy with aav vectors.

Eligibility criteria:
inclusion criteria: * subjects who were previously enrolled in the study "a two-stage dose-escalation study to evaluate the safety and efficacy of bilateral intraparenchymal thalamic and intracisternal/intrathecal admin of axo-aav-gm2 in tay-sachs or sandhoff disease." exclusion criteria: * subjects who were not previously enrolled under the initial protocol.
bwh critical care study of careguide for evaluation of emerging or established shock

Conditions: Shock

Summary: this pilot study aims to examine the relationship between continuously measured careguide™ muscle oxygen saturation (smo2), tissue ph and data provided from standard monitoring techniques during the care of subjects with suspected established (cohort a) or emerging (cohort b) shock in the intensive care unit (icu).

approximately 50 subjects meeting recruitment criteria will be enrolled with a minimum of 20 subjects meeting entry criteria for established shock (cohort a). noninvasive near-infrared spectroscopy careguide™ measurements of smo2, tissue ph and hematocrit will be collected from enrollment through device removal. these data will be compared to specific hemodynamic and laboratory parameters obtained as a part of routine care during the careguide™ monitoring period.

Eligibility criteria:
inclusion criteria: subjects who are: 1. to be admitted to the intensive care unit 2. at least 18 years of age 3. men or women 4. informed consent from subject or surrogate 5. clinical diagnosis of established (cohort a) or emerging (cohort b) shock, as described above. exclusion criteria: subjects with: 1. body mass index \>37 2. trauma (primary diagnosis) 3. pregnancy 4. non-global conditions leading to regional increased lactate production (e.g. isolated thrombotic or embolic phenomena, limb, compartment syndrome) 5. known untreated hypothyroidism 6. known hypersensitivity to medical adhesives 7. suspected carbon monoxide poisoning or methemoglobinemia 8. goals of care restricting vital sign acquisition 9. family member of investigators or study staff

Keywords: tissue perfusion noninvasive monitoring near-infrared spectroscopy careguide
continuous and data-driven care (cadence) pilot

Conditions: Pregnancy Related; Opioid Use Disorder

Summary: the proposed project seeks to use public health and clinical data on opioid use disorders (oud) outcomes for mother and infants, which is the leading cause of death to mothers one year after deliver and can lead to neonatal withdrawal syndrome (nows) and other poor outcomes. insufficient or incomplete data about oud and lack of integrated programs for oud treatment during pregnancy can be barriers to providing optimal care to mothers and infants.

maternal opioid use disorder (oud) is the leading cause of maternal mortality in the first year after delivery nationwide. oud also contributes substantially to out-of-home placements in the child welfare system. medication for oud (moud) is the primary standard of treatment, however, access to moud and prenatal care is limited, siloed, and fragmented in florida. gaps in access to and continuity of healthcare (prenatal, postpartum, pediatric, pharmacological and behavioral health) and other services for mothers in oud recovery lead to poor outcomes for parent, child and family. there is also insufficient data integration, due to inconsistent data collection methods or use of diagnostic codes, to identify mother-infant dyads affected by oud that could inform optimal care at the local level. single-site studies that integrate substance use disorder programs in pregnancy have been shown to improve neonatal and maternal outcomes. with that in mind, the long-term goal of this study is to leverage high-quality local and timely data to improve oud outcomes before, during, and after pregnancy with an integrated care approach that can be replicated throughout the state. the objective of the proposed project is to consolidate multiple streams of public health and clinical healthcare data to analyze equitable access and outcomes for families affected by maternal oud for use in quality improvement cycles to rapidly refine our integrated cadence (continuous and data-driven care) program. our central hypothesis is that integrated, continuous, data-driven care will improve cadence patient outcomes. we will test this hypothesis through the following aims: 1) create an interactive data dashboard for maternal, neonatal, and infant outcomes for pregnancies affected by oud; 2) pilot the cadence program and rapidly refine using a data-driven approach.

Eligibility criteria:
inclusion criteria: * patients with known opioid use disorder over the age of 18 years old who are pregnant exclusion criteria: * patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant
ivermectin neurotoxicity and abcb1 gene mutations

Conditions: DNA Sequencing

Summary: the study report a unique case of severe intoxication in a child treated with oral ivermectin to prevent scabies infection. the abcb1 gene sequencing found the child compound heterozygote for two nonsense mutations, one in each gene copy. the child had inherited from each parent one of the alleles. each mutation generate a predicted truncated protein that likely lead to abcb1 loss of function, and the undesirable effects observed. the study report a unique case of severe intoxication in a child treated with oral ivermectin to prevent scabies infection. the abcb1 gene sequencing found the child compound heterozygote for two nonsense mutations, one in each gene copy. the child had inherited from each parent one of the alleles. each mutation generate a predicted truncated protein that likely lead to abcb1 loss of function, and the undesirable effects observed. while in some animals, nonsense abcb1 mutations can lead to neurotoxicity of several abcb1-substrate drugs, in humans, ivermectin was considered to have an especially high margin of safety, and nonsense mutations have never been reported before, nor has the neurotoxicity of ivermectin apparently caused by these two mutations never been reported before. this discovery is of critical importance for the child, since it dictates that clinicians would need to optimize any abcb1 substrate-based therapy in the future. more generally, such information must be brought to the attention of clinicians' medics, and in particular infectious disease specialists, pediatricians, and general practitioners. it points the importance of pharmacovigilance, and the benefit of pharmacogenomic genotyping in well-defined phenotype, still too rarely considered in clinical practice before the implementation of a drug treatment. this work results from a multidisciplinary approach, combining several areas of expertise in clinical pediatrics, pharmacology, biology, and bioinformatics.


Eligibility criteria:
inclusion criteria: * episode of neurotoxicity exclusion criteria: * na

Keywords: ivermectin neurotoxicity atp binding cassette subfamily b member 1 abcb1/p-glycoprotein (p-gp) multidrug transporter drug adverse event ivermectin toxicity
impact of frailty and icu-aw on post-icu fatigue self-reported

Conditions: Post Intensive Care Syndrome

Summary: after a prolonged stay in intensive care unit (icu), fatigue is the most common symptom reported by patients in the post intensive care syndrome (pics). other complications have been described, including icu-acquired weakness, leading to increased morbidity and mortality after discharge. actually, risk factors associated with post-icu fatigue self-reported are not really known.

frailty, defined as a decrease in physiological reserves leading to an alteration in the mechanisms of adaptation to stress, increases the incidence of pics and could therefore be a cause of post-icu fatigue self-reported. the aim of this study is to identify a relationship between markers of frailty, icu-aw, icu story and the post-icu fatigue self-reported 6 months discharge in patients with prolonged icu stays.

Eligibility criteria:
inclusion criteria: * patients with a length of stay in intensive care \> or equal to 7 days, or mechanical ventilation \> or equal to 5 days exclusion criteria: * scheduled surgery with admission in icu * pregnancy * guardianship

Keywords: intensive care unit frailty fatigue icu acquired-weakness facit-f physical activity
the additive value of pyridostigmine to silodosin in acute urinary retention

Conditions: Prostatic Hyperplasia

Summary: acute urine retention, aur, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (bph). aur is defined as the sudden and painful inability to void freely. this study aims to evaluate whether pyridostigmine bromide added to silodosin is beneficial in treating acute urine retention caused by bph.

aur, or acute urine retention, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (bph). aur is defined as the sudden and painful inability to void freely. (hartung, 2001). between 0.4 and 25% of males seen in routine urological care are reported to have aur each year (schulman, 2001). according to a significant us cohort study, if a 60-year-old man survived for another 20 years, his probability of experiencing an aur episode would be 23% (jacobsen et al., 1997). the current standard of care for aur typically involves immediate bladder catheterization, followed by subsequent removal of the catheter to test whether normal voiding returns, that is, a trial without a catheter (twoc) (gwon et al., 2023).

Eligibility criteria:
inclusion criteria: * patients with a retention volume of less than 1000 milliliters who were over 50 years old and going through their first episode of acute urine retention (aur) due to benign prostatic hyperplasia (bph) were included in this study exclusion criteria: * the individuals who do not meet the eligibility requirements are those who have been diagnosed with an infection of the urinary tract, have repeatedly retained urine, have had unsuccessful trial voiding procedures in the past, have a retention volume of more than one liter, have had a history of prostatic or bladder neck surgery, have been diagnosed with prostate carcinoma, have experienced urethral stricture, have a neurogenic bladder, have been diagnosed with renal failure, or have been diagnosed with liver disease.
effect of cpap (continuous positive airway pressure) on lung function in asthmatics with sleep apnea

Conditions: Asthma; Sleep Apnea

Summary: this is a research study of asthma and sleep apnea. our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. we believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. this study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. this study involves 2 bronchoscopies.


Eligibility criteria:
inclusion criteria: * adult (\>18yrs at the time of recruitment) * body mass index (bmi) ≥ 30 * symptoms suggestive of sleep apnea * epworth sleepiness score (ess) within range * positive sleep study for sleep apnea exclusion criteria: * tobacco use within the last 3 months. * presence of other significant comorbid heart or lung disease * presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection. * use of systemic steroids, as defined as any prednisone use in the preceding 3 months. * use of leukotriene antagonists or theophylline within the preceding 6 weeks. * presence of severe or uncontrolled sinusitis, such that cpap therapy will be difficult or uncomfortable. * history of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of cpap therapy. * night shift workers, or other subjects with significantly altered sleep-wake cycles. * baseline post-bronchodilator fev1 \< 70% predicted. * severe gastroesophageal reflux disease.

Keywords: asthma sleep apnea obesity cpap
pain-related self-efficacy in individuals with chronic neck pain

Conditions: Neck Pain

Summary: the factors affecting pain-related self-efficacy in individuals with chronic neck pain were investigated. a total of 69 subjects participated in the study. after the demographic data of the subjects were taken, pain-self-efficacy questionnaire, timed up and go test, berg balance scale and international physical activity questionnaire were administered, respectively.


Eligibility criteria:
inclusion criteria; 1. adults aged 30 to 65 years, 2. adults with neck pain for at least 3 months, 3. having a score of 3 or more on the visual analog scale for pain , 4. to be willing to participate in the study. exclusion criteria; 1. diagnosed with neurological, vestibular, rheumatic, or endocrine disorders, 2. had previous spinal surgery, neck trauma associated with post-traumatic amnesia or concurrent head injury, or cervical fracture or dislocation, 3. currently receiving treatment for neck pathology.

Keywords: neck pain self efficacy physical activity
serotonin and everyday social interaction

Conditions: Social Behaviour

Summary: rationale: poor social functioning may contribute to major depressive disorder (mdd). poor serotonin function may also contribute to mdd. recent research suggests that serotonin plays a role in regulating human social behaviour. therefore it would be intriguing to investigate the role of serotonin in regulating the quality of everyday social interactions in a population at risk for mdd. human social behaviour can be reliably assessed in everyday life using ecological momentary assessment (ema). objective: this study aims to investigate how an experimental increase in serotonin influences social functioning in healthy adults with a first-degree family member diagnosed with mdd. the primary goal is to investigate the role of serotonin in regulating everyday social behaviour, measured using ema. this will be done using oral supplementation with tryptophan, the amino acid precursor of serotonin. secondary goals are to determine how this experimental manipulation influences people's feelings as well as their perceptions of other's social behaviour following interpersonal events, and social cognitions at the end of the day. an exploratory goal is to investigate if these effects are moderated by genes thought to be involved in mdd. the primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.


Eligibility criteria:
inclusion criteria: * age 18-65 years * at least one first-degree family member with mdd * willingness to cooperate; to sign written informed consent exclusion criteria: * any current or past mdd or other mood disorder as determined by the structured clinical interview for the diagnostic and statistical manual for mental disorders (scid) * any current anxiety disorder, psychotic disorder, substance use disorder, eating disorder, or somatoform disorder as determined by scid * any contraindication for the use of tryptophan, i.e. pregnancy, diabetes, cancer or a history of cancer, a history of any scleroderma-like condition, evidence of achlorhydria, upper bowel malabsorption, or irritation of the urinary bladder * current use of psychotropic medications including medications for psychiatric problems (e.g., antidepressants such as mono amine oxidase inhibitors and fluoxetine) or migraines * not speaking dutch fluently