Kornimate/medical-research-clean huggingface dataset:
safe and explainable ai

Conditions: Artifical Inteligence; Cardiology; Breast Cancer; Sepsis

Summary: while current ai technology is suitable for automating some repetitive clinical tasks, technical challenges remain in solving critical and gainful problems in the domains of patient and disease management. the proposed research seeks to address issues in medical ai, such as integrating medical knowledge effectively, making ai recommendations explainable to clinicians, and establishing safety guarantees.


Eligibility criteria:
inclusion criteria: cardiology 18 years of age and older, admitted to any of the penn medicine hospitals from 2017 to the present. sepsis 18 years of age at the time of presentation to an emergency department or admission to any penn medicine hospital from july 1, 2017, onward will be eligible as this represents the population at risk for acquiring sepsis oncology 18 years of age and older with a diagnosis of invasive breast cancer (stage 1-4) in the penn cancer registry exclusion criteria all prediction models will exclude patients under the age of 18 from their patient data sets. cardiology patients whose primary admission diagnosis was cardiac arrest sepsis those with pre-existing limitations on life-sustaining therapy will be excluded because their eligibility for sepsis definitions, care received, and outcomes, may be significantly and variably affected by pre-existing limitations on care. oncology there are no other exclusions.
safety and efficacy evaluation of a new contact lens disinfecting solution in gas permeable contact lens wearers

Conditions: Myopia; Astigmatism; Hyperopia; Refractive Error

Summary: the purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in gas permeable lens wearers.

subjects with normal eyes (other than correction for refractive error) successfully wearing silicone acrylate or fluoro silicone acrylate gas permeable contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Eligibility criteria:
inclusion criteria: * normal eyes (other than correction for visual acuity); * successful history of gas permeable contact lens wear in both eyes in one of two brands: boston xo or boston ii; * best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye; * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study; * need to wear contact lenses on an extended wear basis (ie, overnight) during the study; * use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to visit 1; * history of intolerance or hypersensitivity to any component of the investigational products; * use of all over-the-counter (otc) or prescribed topical ocular medications within 7 days prior to visit 1; * moderate, severe, abnormal, or other ocular findings; * current or history of ocular infection, severe inflammation, or disease within 6 months prior to visit 1; * any systemic disease at visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions; * use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen; * ocular surgery within the last 12 months; * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses contact lens solution gas permeable contact lenses
inflammation and cardiovascular health in women

Conditions: HIV/AIDS; Myocardial Infarction

Summary: systemic immune activation and inflammation are believed to play a significant role in the development and clinical course of myocardial infarction (mi). among women with hiv (whiv), heightened systemic immune activation and inflammation persist, even when hiv infection is well-treated with contemporary antiretroviral therapeutic regimens. moreover, whiv in high-resource regions face a three-fold increased risk of myocardial infarction as compared with matched non-hiv-infected women. the goals of this study are to better understand ways in which hiv infection-incited systemic immune activation and inflammation augment mi risk among women.

the goals of this study are to better understand ways in which hiv infection-incited systemic immune activation and inflammation augment mi risk among women. to this end, whiv and non-hiv-infected women will undergo structural and functional cardiovascular imaging studies (cardiac pet, 99mtc-tilmanocept spect/ct, contrast enhanced coronary and aortic computed tomography angiography) as well as vascular, metabolic/hormonal, and immune phenotyping. measures of immune activation, arterial inflammation, and cardiovascular pathology will be compared between groups and interrelationships between these parameters will be assessed among whiv.

Eligibility criteria:
whiv: inclusion * female nascent sex * hiv * age 40-79 * self-report of stable art for at least 180 days prior to study entry - any regimen (no more than 30 days missed medication in the last 180 days) exclusion * self-reported history of mi, stroke, coronary revascularization * stable or unstable angina symptoms * a pre-existing diagnosis of diabetes, being actively treated with oral or injectable antihyperglycemic medication * current cocaine use * current use of exogenous oral, or transdermal, injected, or depot estrogen or testosterone * current treatment with prescription, systemic (oral, iv, or im) steroids, or anti-inflammatory/immune suppressant medical therapies (excluding topical therapies, uv therapy, asa-derivative therapies, or nsaids) for autoimmune/inflammatory diseases (psoriasis, ra, ibd, lupus), post-transplant care, asthma, or pain syndromes * use of oral steroids or prescription oral anti-inflammatory/immune suppressant medication for \>7 days within the past 30 days prior to entry * pregnant or breastfeeding * egfr \< 60 ml/min/1.73 m2 calculated by 2021 ckd-epi creatinine * known severe allergy to iodinated contrast media (ccta), dextrans/dtpa/radiometals (99mtc-tilmanocept spect/ct), or regadenoson/adenosine (cardiac pet/ct). * self-reported significant radiation exposure (\>2 ct angiograms) received within the past 12 months * concurrent enrollment in conflicting research study. non-hiv-infected women: as above, save for addition of inclusion criteria for negative hiv test and absent inclusion criteria for hiv and self-report of stable art.

Keywords: women arterial inflammation systemic immune activation endothelial dysfunction cardiovascular disease risk
study of srp-4045 (casimersen) and srp-4053 (golodirsen) in participants with duchenne muscular dystrophy (dmd)

Conditions: Duchenne Muscular Dystrophy

Summary: the main objective of this study is to evaluate the efficacy of srp-4045 (casimersen) and srp-4053 (golodirsen) compared to placebo in participants with dmd with out-of-frame deletion mutations amenable to skipping exon 45 and exon 53, respectively.

this is a double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of srp-4045 and srp-4053. eligible participants with out-of-frame deletion mutations amenable to exon 45 or 53 skipping will be randomized to receive once weekly intravenous (iv) infusions of 30 milligrams/kilograms (mg/kg) srp-4045 or 30 mg/kg srp-4053 respectively (combined-active group) or placebo for up to 96 weeks (the placebo-controlled period of the trial). this will be followed by an open-label extension period in which all participants will receive open-label active treatment for 48 weeks (up to week 144 of study). the study will enroll approximately 222 participants. twice as many participants will be randomized to receive active treatment as will receive placebo (2:1 randomization). clinical efficacy will be assessed at regularly scheduled study visits, including functional tests, such as the 6-minute walk test (6mwt). all participants will undergo a muscle biopsy at baseline and a second muscle biopsy either at week 48 or week 96. safety will be assessed through the collection of adverse events (aes), laboratory tests, electrocardiograms (ecgs), echocardiograms (echos), vital signs, and physical examinations throughout the study. blood samples will be taken periodically throughout the study to assess the pharmacokinetics of both drugs.

Eligibility criteria:
inclusion criteria: * genotypically confirmed dmd, with genetic deletion amenable to exon 45 or exon 53 skipping * stable dose of oral corticosteroids for at least 24 weeks prior to week 1, and the dose is expected to remain constant throughout the study (except for modifications to accommodate changes in weight). * intact right and left biceps brachii muscles or 2 alternative upper arm muscle groups * mean 6mwt ≥300 meters and ≤450 meters * stable pulmonary function: forced vital capacity (fvc) ≥50% predicted exclusion criteria: * treatment with gene therapy at any time * previous treatment with smt c1100 within 1 week prior to week 1 and previous treatment with pro045 (bmn 045), pro053 (bmn 053), or pro051 (bmn 051) within 24 weeks prior to week 1 * current or previous treatment with any other experimental treatment within 12 weeks prior to week 1 * major surgery within 3 months prior to week 1 * presence of other clinically significant illness * other inclusion/exclusion criteria may apply.

Keywords: duchenne muscular dystrophy exon skipping dmd exon 53 exon 45 ambulatory pediatric duchenne
atrial fibrillation in active cancer patients

Conditions: Cancer; Drug Toxicity; Atrial Fibrillation; Cardiovascular Complication

Summary: atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase iii oncological trials and cardiological guidelines. the objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.


Eligibility criteria:
inclusion criteria: * adult patients * outpatients or hospitalized patients * with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment) * at least 1 episode of atrial fibrillation (new onset af occuring after cancer diagnosis or history of paroxysmal of persistant af prior to cancer diagnosis and an af recurrence after cancer diagnosis) * in sinus rhythm at the time of cancer diagnosis exclusion criteria: * patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence) * history of long-standing persistant or permanent af prior to cancer diagnosis
effects of mindfulness meditation and stress management after breast cancer

Conditions: Breast Cancer

Summary: the primary aim of this study is to examine the effects of a mindfulness-based stress reduction training program, delivered in individual web-based sessions, among breast cancer patients. the objectives are to study and answer questions regarding effects of the such training in a randomized controlled trial including the following outcome measures: physical and mental health status, perceived stress, post-traumatic stress symptoms, psychological well-being, and sleep quality. in addition to the primary aim, the investigators plan to explore potential mechanisms through which mindfulness training lead to improvement in perceived stress, well-being and sleep-quality. this will be studied by mediational analyses.


Eligibility criteria:
inclusion criteria: * breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously * access and regular use of the internet exclusion criteria: * non swedish speaking * previous sever psychiatric illness

Keywords: mindfulness stress reduction training expressive writing condition waiting list control condition
effect of paracetamol and mannitol injection on postoperative analgesia in patients with thoracoscopic lobectomy

Conditions: Postoperative Analgesia

Summary: this study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group.


Eligibility criteria:
inclusion criteria: 1. obtain informed consent； 2. patients scheduled for partial lobectomy under thoracoscopy with general anesthesia； 3. classified as american society of anesthesiologists (asa) physical status i\~ii； 4. age over 18 years； 5. patients voluntarily participate and sign the informed consent form exclusion criteria: 1. systolic blood pressure ≥180 mm hg or \<90 mm hg, diastolic blood pressure ≥110 mm hg or \<60 mmhg 2. heart rate \<50 beats/min； 3. patients with severe liver or kidney dysfunction (severe liver dysfunction: alt, conjugated bilirubin, ast, alp, total bilirubin any one \>2 times the upper limit of normal 4. severe kidney dysfunction: creatinine clearance \<60 ml/min)； 5. patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)； 6. patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease； 7. history of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse； 8. neuromuscular diseases； 9. tendency towards malignant hyperthermia； 10. allergy to the study drug or other contraindications； 11. participation in another drug clinical trial within the past 30 days； 12. any cerebrovascular accidents such as stroke, transient ischemic attack (tia) in the last 3 months； 13. unstable angina, myocardial infarction in the last 3 months； 14. undergone another surgery within the last 3 months； 15. coagulopathy

Keywords: paracetamol and mannitol injection postoperative analgesia thoracic surgery
behavioral treatment for cocaine dependent women

Conditions: Cocaine Dependence

Summary: to compare the efficacy of community reinforcement approach (cra) and 12-step facilitation (tsf) counseling and of voucher based reward therapy (vbrt) and a yoked, non-contingent voucher control (vc) for the treatment of cocaine dependent pregnant women or women with young children.

subjects were randomly assigned to 1 of 4 treatment groups (cra+vbrt, cra+vc, tsf+vbrt, tsf+vc). vbrt voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. all subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. manual-guided cra and tsf were provided by experienced clinicians.

Eligibility criteria:
inclusion criteria: * pregnant women meeting dsm iv criteria for cocaine dependence * women meeting dsm iv criteria for cocaine dependence with custody of a young child exclusion criteria: * opioid dependence * psychosis * severe depression * current treatment with any anti-depressant or anti-psychotic medication * medical instability * inability to understand or read english

Keywords: community reinforcement approach contingency management 12-step facilitation counseling cocaine dependence women
positive pressure treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?

three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.

Eligibility criteria:
inclusion criteria: * age 21 - 75 * diagnosis of osahs with baseline ahi (apnea-hypopnea index) equal or greater than 15 events/hr of sleep * able and willing to provide written informed consent * agreement to try pap (positive airway pressure) as initial treatment approach * adequate clinical cpap titration within two weeks of enrollment exclusion criteria: * participation in another interventional research study within the last 30 days * the need for more than one titration psg (polysomnography) * the use of sedatives or hypnotics during the titration psg * major medical or psychiatric condition that would interfere with the demands of the study, adherence to pap or the ability to commit to follow-up assessment. * prior prescription for, or exposure to pap therapy within the previous year (except exposure to cpap during clinical therapy titration.) * chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe copd (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\>45 mmhg) while awake or participants qualifying for oxygen therapy (arterial saturation \< or equal to 88% for more than five minutes). * surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days * surgery at any time for the treatment of osahs such as uvulopalatopharyngoplasty (uppp) * presence of untreated or poorly managed, non-osahs related sleep disorders: * moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals) * restless leg syndrome (greater than 10 per hour) * males experiencing chronic insomnia * use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week. * consumption of ethanol more than 4 nights per week (cage criteria) * shift workers
progesterone levels during ovulation and luteal phase

Conditions: Infertility, Female

Summary: natural cycles are evaluated during fertility treatments for different therapeutic options, like insemination (iui), time intercourse (ti) or frozen-thawed embryo transfers (fet). two possible protocols can be used for natural cycles, with or without hcg trigger. usually, studies including natural cycles consider both options as equivalent, not considering the possible bias that the exogenous hcg (human chorionic gonadotrophin) might have. in this prospective study, investigators aim to evaluate the differences in the hormonal profile during the ovulation when it occurs spontaneously vs triggered with a bolus of hcg.

for the pure natural cycle (pnc), ovulation will be detected by a combination of ultrasound monitoring the follicular growth and serial measurement of luteinizing hormone (lh), estradiol (e2) and progesterone (p4) levels, which is recognised to be the most accurate method of correctly identifying ovulation. for the modified natural cycle (mnc), a bolus of rhcg 6500 iu subcutaneous (sc) will be administered when 1 dominant follicle reaches 17mm or above, after excluding previous lh surge. this is the first prospective study where the differences on the hormonal profile for ovulation will be studied. hypothesis: h0: the hormonal profile is not different between the pnc and the mnc h1: the hormonal profile is different between the pnc and mnc administration of hcg is a popular method for triggering ovulation since it may avoid the need to perform iui or fet at weekends. however, it is an intervention compared with the detection of the spontaneous lh rise. moreover, due to the presence of hcg receptors in the human endometrium, administration of hcg might interfere with endometrial receptivity. previous publications evaluating pregnancy rates demonstrated that the use of hcg injection during the natural cycle reduces the pregnancy rates, in fet and iui. it remains unclear what might be the mechanism to explain the lower pregnancy rates: a possible direct effect of hcg on the hcg receptors of the endometrium or a modification of the hormonal profile after the administration of the hcg, affecting the window of implantation (woi).

Eligibility criteria:
inclusion criteria: * healthy women below 40 years * regular and ovulatory cycles exclusion criteria: * previous adnexal surgery * endometriosis * pcos * using hormonal contraception during the previous 2 months: ocp, progesterone iud

Keywords: luteal phase natural cycle human chorionic gonadotropin progesterone progesterone rise ovulation
docetaxel and cisplatin chemotherapy with or without high dose proton pump inhibitor in metastatic breast cancer

Conditions: Breast Cancer; Metastasis, Neoplasm

Summary: the objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.

high dose proton pump inhibitor (ppi) has been proved beneficial and it improved efficacy when combined with chemotherapy in preclinical and clinical trials.this study was designed to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy improves efficacy and does not affect tolerability in metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * signed informed consent. * female, ≥ 18 years. * histologically confirmed invasive breast cancer. * metastatic breast cancer. * karnofsky performance status ≥60. * life expectancy of more than 3 months. * subject must have adequate organ function. * normal laboratory values: hemoglobin \> 80g/dl, neutrophils \> 2.0×10\^9/l, platelets \> 80×10\^9/l, serum creatinine \< upper limit of normal (uln), serum bilirubin \< uln, alt and ast \< 2.5×uln, akp \< 5×uln. * negative serum pregnancy test for women with childbearing potential. * good conditions for infusion and willing to have phlebotomy throughout whole study. * have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days. * have at least one target lesion according to the response evaluation criteria in solid tumors (recist) criteria. * no prior use of docetaxel or has used docetaxel in adjuvant/neo-adjuvant chemotherapy and has a relapse free survival of at least 12 months. exclusion criteria: * pregnant or lactating females. * history of other malignancy. however, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. * concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety. * active or uncontrolled infection. * known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure. * concomitant with brain metastases. * have received chemotherapy after metastasis.

Keywords: metastasis breast cancer proton pump inhibitor chemotherapy phase ii study ttp