Kornimate/medical-research-clean huggingface dataset:
study to evaluate effect of a single dose of sotatercept (ace-011) on red blood cell mass and plasma volume in participants with solid tumors

Conditions: Solid Tumors

Summary: what hematopoietic precursor compartments as well as hemoglobin subtypes are affected by dosing with sotatercept (ace-011)? based upon a similar prior study with procrit, celgene has determined that all of these goals could be obtained by an intense 10-patient sotatercept (ace-011) pharmacodynamic study, completed by two well-known experts in the red cell production field.


Eligibility criteria:
inclusion criteria: * men and women ≥18 years of age. * histologically confirmed diagnosis of a solid tumor malignancy documented by cytology or biopsy. * presence of metastatic disease. * hemoglobin value between ≥8.0 to \<11.0 g/dl (≥80 to \<110 g/l). * ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume test) since previous treatment with erythropoiesis-stimulating agent (including concurrent treatment with intravenous \[iv\] iron). * ≥28 days must have elapsed (prior to day 1) since the last red blood cell transfusion and receipt of ≤2 units of blood in the past 56 days (prior to day 1). * eastern cooperative oncology group (ecog) performance status of 0 - 1. exclusion criteria: at the time of screening, participants who have any grade ≥3 toxicity (according to the currently active minor version of nci ctcae v4.0) except for the following disease-related toxicities: * hematological events - anemia, thrombocytopenia, neutropenia * non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain

Keywords: red blood cell mass plasma volume solid tumors
online coping skills counseling for problem gambling and trauma

Conditions: Gambling Disorder; Trauma, Psychological; Problem Gambling; Posttraumatic Stress Disorder

Summary: this randomized controlled trial examines the efficacy of two behavioral therapies. seeking safety, which addresses co-occurring problem gambling (pg) and posttraumatic stress disorder (ptsd), is being compared to cognitive-behavioral therapy for pg, which addresses only pg. both models are delivered via telehealth.

our key study question is whether an integrated focus on pg and ptsd (seeking safety; ss) offers a useful new option for clinical care compared to a purely problem gambling approach (cognitive-behavioral therapy for pg; cbt-pg). this question-the impact of integrated versus non-integrated treatment for co-occurring disorders-is one of the key issues in the field currently and has never been studied in relation to pg and ptsd. our aims are: 1. to conduct an rct of ss versus cbt-pg in a sample of 84 people with current pg and ptsd (full or subthreshold). 2. to evaluate outcomes from baseline to end of treatment and 12 month followup on two primary variables (money lost gambling and number of gambling sessions) and several secondary variables. our hypotheses are: (a) ss will do no worse than cbt-pg on the primary pg outcomes as both treatments are designed to address addiction; i.e., both will show improvement from baseline to end of treatment and maintenance of gains through the followup. (b) ss will show superior results on trauma symptoms as ss is designed to address those, whereas cbt-pg is not.

Eligibility criteria:
inclusion criteria: * age 18 and over * recruited from the province of manitoba, canada * meets criteria for ptsd (full or subthreshold) on the clinician-administered ptsd scale (caps) * meets gambling disorder criteria per the dsm-5 diagnostic interview of gambling severity exclusion criteria: * current uncontrolled psychotic or bipolar i disorder * suicidal or homicidal ideation with intent and/or plan * currently engaging in or planning to engage in any manualized, formal, evidence-based ptsd therapy
glp 1 for intraoperative glycemic control

Conditions: Hyperglycemia; Hypoglycemia

Summary: this is a medical research study designed to see if an infusion of a naturally occurring hormone, glp-1, works when used to decrease blood sugar during cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. male or female age (18-80 years), 2. ability to provide informed consent, 3. elective cabg with or without single or multivalve repair or replacement, and/ or 4. single or multivalve repair or replacement requiring cpb and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery). exclusion criteria: 1. concomitant surgery (e.g. carotid endarterectomy), 2. emergent surgery, 3. current steroid use, 4. insulin dependent diabetes mellitus (iddm), 5. cardiac surgery without the use of cardiopulmonary bypass (e.g. off-pump cabg), 6. current use of positive intravenous inotropic agents, 7. serious intercurrent illness (endocarditis, sepsis, active malignancy requiring treatment) or active infection, 8. known substance abuse, 9. receipt of an investigational drug or device within 30 days prior to surgery, 10. known allergy to any of the following: glp-1, fentanyl, midazolam, isoflurane, propofol, morphine, heparin or protamine, 11. sulfonylurea medication administration on morning of surgery (such as, tolbutamide, tolazamide (tolinase), chlorpropamide (diabinese). glipizide (glucotrol, glucotrol xl), glyburide (micronase, glynase prestabs, and diabeta), glimepiride (amaryl), 12. major end organ dysfunction defined as: 1. cardiac: left ventricular ejection fraction (lvef) \< 30% by left ventriculography or echocardiogram (within 90 days prior to randomization), current use of positive intravenous inotropic agents, preoperative use of intra-aortic balloon pump (iabp), left ventricular assist device (lvad), or extracorporeal membrane oxygenation (ecmo); 2. renal: preoperative serum creatinine \> 2.0 mg/dl; 3. hepatic: aspartate aminotransferase (ast) or alanine transferase (alt) \> 2.5 x upper limit normal; 4. hematologic: preoperative hematocrit (hct) \< 30%, platelet count \< 100,000/mm3, history of (or family history of) bleeding or clotting disorder; 13. patients with a history of or risk factors for acute pancreatitis (i.e. ethanol abuse, gall stones) will be excluded from this study, 14. pregnant or breastfeeding females, or 15. any other condition that, in the opinion of the investigator, may compromise the safety of the subject or would preclude the subject from successful completion of the study.

Keywords: cardiac surgery glycemia
intrathecal therapy for adult tuberculous meningitis: impact on clinical outcomes

Conditions: Tuberculous Meningitis

Summary: tuberculous meningitis (tbm) is the most lethal form of tuberculosis (tb). while anti-tb regimens remain the cornerstone of treatment, spinal injection of dexamethasone is considered a potentially effective adjuvant therapy. however, its impact on mortality and disability remains uncertain. this study analysed all tbm patients admitted to beijing chest hospital affiliated with capital medical university from january 1, 2010 to december 31, 2023. patients were categorised into two groups based on whether they received standard anti-tb therapy with dexamethasone via spinal canal administration (intrathecal therapy group) or standard anti-tb therapy alone (non-intrathecal therapy group). propensity score matching was used to balance baseline characteristics, and one-year mortality and severe disability rates were statistically compared between the groups.


Eligibility criteria:
inclusion criteria: * 1. a positive pathogenic diagnosis of tuberculous meningitis, or clinical diagnosis of tuberculous meningitis, refer to the 《2019 chinese guidelines for the diagnosis and treatment of central nervous system tuberculosis》; 2. complete patient information can be found, included patients' demographic characteristics, medical histories, presenting signs and symptoms, clinical course, laboratory test results, diagnostic studies, treatments, complications; 3. patients can be collected from the time of diagnosis and medication to 12 months. exclusion criteria: * 1. hiv positive patients (as hiv positive patients in china require diagnosis and treatment in specific healthcare systems); 2. patients who are unable to collect complete demographic information, diagnostic and treatment information, or treatment outcomes.

Keywords: intrathecal therapy tuberculous meningitis outcome
pre-sunbeam tewl auc

Conditions: Atopic Dermatitis

Summary: transepidermal water loss (tewl) measurements are a valuable tool to determine the integrity of a person's skin barrier. in patients with skin conditions, like atopic dermatitis, skin barrier can be disrupted or weakened, leading to a more severe phenotype and disease characteristics. there are several commercially available tewl measuring devices, including the aquaflux af200 and the gpskin barrier pro. this study is a pilot study to determine if these two devices produce similar readings for tewl/skin barrier on patients with and without atopic dematitis (ad). the research team would like to investigate whether these devices are comparable for initial tewl readings as well as after several rounds of tape strips have been collected from the skin. tape strips are small circular adhesives, much like tape, that remove the very outermost layers of skin cells. it will be important to know if both of these devices provide correlative values for tewl once the outermost layers of the skin have been removed by tape stripping.


Eligibility criteria:
inclusion criteria: 1. parent guardian must be able to understand and provide informed consent and participant provide assent as applicable per institutional review board (irb) guidelines and regulations. 2. male or female, less than or equal to 3 years of age inclusive at screening 3. active ad using standard diagnostic criteria (aad criteria, eichenfield et al, 2014). participant must have an area of non-lesional ad (easi of 0) within 5 cm. of the measured lesional area within the same region. participant must have lesional and nonlesional areas of at least 3 cm in diameter to allow for both devices to be tested in contiguous areas or for healthy controls 4. participant must meet all of the following criteria: 1. no personal history or current manifestations of ad; no current food allergy, asthma, allergic rhinitis (based on self-report) 2. no evidence of dry skin or other skin issue (easi score of 0) exclusion criteria: 1. inability or unwillingness of a parent guardian to give written informed consent, or participant to give assent, if applicable, or to comply with study protocol 2. who have any skin disease other than ad that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies) 3. past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 4. use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on extremity for testing within 2 hours of the enrollment visit.

Keywords: transepidermal water loss
interogating cancer for etiology, prevention and therapy navigation

Conditions: Cancer; Cancer Gene Mutation; PAN Gene Mutation; Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Summary: this study is being done to identify markers and causes of cancer by analyzing patient's dna (i.e., genetic material), rna, plasma, tissues, or other samples that could be informative for patients with cancer. cancer genetic testing is a series of tests that finds specific changes in cancer cells and normal cells in the body. researchers may request to access these data as they explore how to better prevent, screen, or treat cancer. this study is also being done to create a biobank (library) of samples and information to learn more about treating cancer. discovery of genetic variants in patients with cancer could result in opportunities for cancer prevention, earlier diagnosis or better therapy for cancer.


Eligibility criteria:
inclusion criteria: group a: germline and somatic testing * has mayo clinic medical record number * confirmed cancer diagnosis which is either recurrent, relapsed, refractory, metastatic, or advanced * participant aware of cancer diagnosis * able to provide informed consent * ability to provide blood, saliva, bone marrow aspirate or hair follicle sample * ability to provide archived tissue, note: if tissue unavailable participant may still enroll onto the study for the germline collection, or vice versa, if germline has already been completed may still enroll for somatic tissue testing. group b: germline testing only: * has mayo clinic medical record number * confirmed cancer diagnosis * participant aware of cancer diagnosis * able to provide informed consent * ability to provide blood, saliva, or hair follicle sample exclusion criteria: note: women who are pregnant or planning to become pregnant can take part in this study. group a: germline and somatic testing * individuals who have situations that would limit compliance with the study requirements * institutionalized (i.e. federal medical prison) * prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment, and/or * prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment group b: germline testing only * individuals who have situations that would limit compliance with the study requirements * institutionalized (i.e. federal medical prison) * prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment

Keywords: whole exome sequencing (wes) whole genome sequencing (wgs) genetic testing genetic counseling genomics
pre-op cognitive behavior therapy to decrease chronic post-surgical pain in tka

Conditions: Chronic Post-Surgical Pain

Summary: a significant number of patients develop chronic post-surgical pain (cpsp) following knee replacement surgery. proposed is the testing of a novel computer-assisted behavioral intervention integrating motivational interviewing in the 4 weeks prior to surgery to address the risk factors for cpsp, with the expectation that severity of post-op pain and the incidence of cpsp will be reduced.

a significant number of patients develop chronic post-surgical pain following knee joint replacement surgery, and the risk factors for this problematic outcome have been identified. proposed is the development and preliminary efficacy testing of a novel computer-assisted cognitive behavioral intervention integrating motivational interviewing delivered in the four weeks prior to surgery to address these risk factors, with the expectation that both the severity of post-operative pain and the subsequent incidence of chronic post-surgical pain will be reduced. in that chronic post-surgical pain brings with it diminished functionality and quality of life, ongoing opioid use, and direct patient costs, it is critical that interventions aimed at mitigating its development are implemented and evaluated in the clinical setting. in a sample of adults over the age of 21 with chronic pain undergoing a planned tka, the objectives of this randomized clinical trial are to: 1. add a motivational interviewing component to a validated computer-assisted cbt intervention for chronic pain (paintrainer) to encourage opioid tapering, if applicable, and program adherence in the 4 weeks prior to surgery in patients scheduled to undergo a tka. 2. describe the efficacy of the 4-week targeted pre-operative cbt intervention in 45 tka patients to decrease preoperative chronic pain severity, preoperative opioid consumption, and symptoms of depression, anxiety and pain catastrophizing prior to surgery in comparison to 45 tka patients randomized to treatment-as-usual. 3. describe the effects of a 4-week targeted pre-operative cbt intervention in 45 tka patients on 48hr post-operative pain severity, and 3- and 6-month rates of cpsp in comparison to 45 tka patients randomized to treatment-as-usual.

Eligibility criteria:
inclusion criteria: 1. males and females, age \> 21 years 2. chronic non-malignant pain of at least 3 months duration 3. morphine equivalent daily dose (medd) \> 40 milligrams for at least 3 months 4. able to enroll at least 4 weeks prior to planned surgery 5. able to speak, read and comprehend in english at the 6th grade or higher proficiency exclusion criteria: 1. pain of malignant origin 2. current or past history of opioid use disorder (including those on medication-assisted therapy) 3. revision of tka 4. comorbid cns disease such as dementia, hiv, psychosis, poorly controlled bipolar disorder or any condition interfering with informed consent

Keywords: cpsp chronic post-surgical pain cognitive behavioral therapy total knee arthroplasty motivational interviewing opioid taper
effect of tranexamic acid (txa) on reduction of postoperative blood transfusion

Conditions: Hip Fractures

Summary: tranexamic acid (txa) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. limited research is available on its use in hip fracture patients. we hypothesize that the use of txa preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.


Eligibility criteria:
inclusion criteria: * over the age of 60 years * hip fracture requiring surgical intervention * signs consent and agrees to participate exclusion criteria: * under the age of 60 * does not sign consent or refuses participation * known hypersensitivity to tranexamic acid * multiple acute fractures * creatinine clearance \<30 * history of seizures * active hormone therapy * history of coagulation abnormality * history of deep vein thrombosis (dvt) or pulmonary embolism (pe) within the last year or history or recurrent dvt/pe * myocardial infarction (mi) and/or stents within the past year * history of intracranial hemorrhage * acquired defective color vision * patients admitted directly to nursing units or surgery without stay in the emergency center * patients who sustain fracture while hospitalized at promedica toledo hospital
pharmacogenomics and post-operative nausea and vomiting

Conditions: Postoperative Nausea

Summary: the researchers overall goal is to evaluate the benefit and utility of preemptive genotypic data to guide post-operative nausea and vomiting treatment in the bariatric surgical population. the hypothesis is that using genotypic variation in cyp2d6 to select the appropriate 5ht3 serotonin receptor antagonist to treat ponv will decrease rates of ponv in the bariatric surgical population.


Eligibility criteria:
inclusion criteria * a mayo clinic patient scheduled to undergo any bariatric surgical procedure, including roux-en-y gastric bypass, sleeve gastrectomy, or duodenal switch. * patient age 18 or above. * patients must understand and provide written informed consent and hipaa authorization prior to initiation of any study-specific procedures. * patient is willing to engage in a medication adjustment as part of their clinical visit (when needed). exclusion criteria * patient with uncontrolled concurrent illness including psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent. * patients that deny access to their medical records for research purposes will not be included in this study. also any patient who will be unable to have genetic testing at minimum of 1 week prior to scheduled surgery or with allergies to ondansetron or granisetron. * any patient with prior genetic testing that is readily available in the medical record will be excluded from this study. * any patient that is pregnant

Keywords: pharmacogenetics cyp2d6 ondansetron granisetron bariatric surgery
clinical comfort evaluation of two marketed spherical contact lenses

Conditions: Astigmatism

Summary: the purpose of this study was to investigate the overall clinical comfort performance of enfilcon a (test) lens and senofilcon a (control) lens over 15-minutes of lens wear.

this was a non-dispensing, single-masked, randomized, contralateral study comparing enfilcon a (test) against senofilcon a (control). each subject was randomized to wear the test lens in one eye and the control lens in the other eye.

Eligibility criteria:
inclusion criteria: 1. based on his/her knowledge, must be in good general health. 2. be 18 to 38 years old. 3. be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation. 4. read, indicate understanding of, and sign written informed consent. 5. be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (avaira or oasys) being evaluated in this trial. 6. require a visual correction in both eyes. 7. require a prescription between +8.00d and -12.00d and have less than or equal to 0.75d of astigmatism in both eyes. 8. achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription. 9. have normal eyes with no evidence of abnormality or disease. for the purposes of this study a normal eye is defined as one having: * no amblyopia. * no evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes). * lamp findings grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection). * no other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology). * no aphakia. exclusion criteria: 1. 0.75d or greater of refractive astigmatism in either eye. 2. presbyopic or current monovision contact lens wear. 3. cannot be currently wearing either lenses (avaira or oasys). 4. presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures. 5. presence of ocular or systemic disease or need of medication which might interfere with contact lens wear. 6. slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula or corneal scars within the visual axis * neovascularization \> 0.75 mm in from the limbus * giant papillary conjunctivitis (gpc) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcer or fungal infections * poor personal hygiene * a known history of corneal hypoesthesia (reduced corneal sensitivity) 7. contact lens best corrected snellen visual acuities (va) worse than 20/30. 8. aphakia, keratoconus or a highly irregular cornea.