Kornimate/medical-research-clean huggingface dataset:
prospective analysis of envisio spatial intelligence for soft tissue localization and guided surgical excision

Conditions: Tumors, Breast

Summary: observational study. the purpose of this study is to evaluate the use of real-time surgical navigation for the localization and surgical removal of soft tissue tumors. the goal is to collect information about the efficiency and effectiveness of the envisio surgical navigation for intraoperative guidance to obtain negative margin on initial specimen. prospective patient study: 200 consecutive patients

objectives 1.) to collect data throughout clinical patient workflow for evaluation of. 1. localization with smartclip(s) 2. negative margin on primary specimen 3. specimen assessment 4. length of operation the envisio® navigation system was cleared as a class ii device by the fda under 510(k) number k183400. the smartclip® soft tissue marker was cleared by the fda under 510(k) number k180640. principal investigator will receive monthly envisio system data from company representative on the envisio system data collection for procedural cross reference resulting in. * date * time of smartclip(s) auto detection * color and number of smartclip(s) * total time of envisio guidance * specimen assessment recordings of smartclip to specimen edge as recorded by electrocautery tip on identified margin medial/lateral/superior/inferior/anterior/posterior) data will be collected from procedures performed including all imaging, clinical and pathologic outcomes. pre and post procedure data including number of individual lesions, localization of mass and number of smartclips used. patients planning surgical excision of an imaging identifiable in-breast will be offered entry into this study; the adventhealth winter garden location will provide standard informed consent form for the purposes of this study. the projected accrual for this study is 200 patients in total.

Eligibility criteria:
inclusion criteria: * patient has image identifiable lesion. * patient has selected breast conservation therapy ie: lumpectomy +/-radiation therapy, +/- chemotherapy +/- hormonal or targeted therapies. neoadjuvant chemotherapy is not an exclusion criterion. * patient will be undergoing target tissue localization with the smartclip * patient will be undergoing bcs breast conserving surgery treatment for dcis or invasive breast cancer with envisio ® navigation system. * patient must be age \> or = 18 years. * patients unable to provide consent to surgery must have authorized representative provide consent. exclusion criteria: * patients undergoing mastectomy for resection of the targeted lesion. * patient is localized with an alternative method. * patient that are pregnant.
detection of celiac disease in patients with hypothyroidism

Conditions: Celiac Disease; Hypothyroidism; Celiac Sprue; Malabsorption

Summary: the study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. it also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.

this study is looking at whether hypothyroid patients who require above 125 mcg/day (or \>1.5mcg/kg/day) of levothyroxine are more likely to have celiac disease than those who require smaller doses. it also looks to see if the prevalence of celiac disease in hypothyroid patients who require elevated doses of levothyroxine is high enough to warrant screening in that population.

Eligibility criteria:
inclusion criteria: * patients with the diagnosis of hypothyroidism that require thyroid replacement therapy. exclusion criteria: * surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.

Keywords: celiac disease hypothyroidism celiac sprue malabsorption
the effect of conservative interventions on the signs and symptoms of diastasis recti

Conditions: Diastasis Recti And Weakness Of The Linea Alba

Summary: the purpose of this study is to determine the effect of two different physiotherapeutic interventions (exercise therapy and/or abdominal binding) on the signs and symptoms of diastasis recti in post-partum women.

this study is investigating the effect of exercise therapy and/or abdominal binding on inter-rectus distance, abdominal muscle strength and endurance, lumbopelvic dysfunction, urogynecological complaints, perceived function, and body image in post-partum women with diastasis recti

Eligibility criteria:
inclusion criteria: * 18 to 35 years old * given birth to their first child, vaginally, in the last three to four weeks * inter-rectus distance of two finger widths of greater on palpation during head lift exclusion criteria: * history of persistent pain with intercourse prior to pregnancy * diagnosed with neurological impairments affecting the central nervous system or sacral nerves * diagnosed with connective tissue disorders

Keywords: diastasis recti physiotherapy exercise therapy abdominal binding
drug interaction study between azd3480 and cytochrome p450

Conditions: Metabolism; Alzheimer's Disease

Summary: the purpose of the study is to evaluate if azd3480 inhibits cytochrome p450 1a2, 2c19, 3a4, 2c8, 2b6 and ugt1a1 activity.


Eligibility criteria:
inclusion criteria: * provision of signed written informed consent * clinically normal physical findings and laboratory values exclusion criteria: * clinically significant illness or clinically relevant trauma within three weeks before the first dose * history of clinically significant disease * use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Keywords: azd3480 cocktail caffeine bupropion omeprazole midazolam rosiglitazone metabolism drug drug interaction
understanding post-translational modifications to circulating histones via mass spectrometry in pregnant women developing pre-eclampsia: a retrospective study

Conditions: Pregnancy Related; Pre-Eclampsia

Summary: this is a descriptive pilot study on a ready-constituted biobank (outside the jardé law). it is an ancillary study to the "grosspath" cohort (rcb id number: 2014-a01120-47). pregnancy generates an increased risk of thrombosis, and placenta-mediated diseases constitute a risk factor for cardiovascular pathologies responsible for significant maternal-fetal morbidity and mortality. understanding and exploring the cellular and molecular mechanisms of dysfunctions of the vascular-placental interface could provide arguments to understand the systemic vascular risk, characterize it and finally detect it on the basis of new markers, thus opening the way for targeted preventive management to reinforce the general principles of precision medicine. netosis is a process of activation of neutrophils, which then generate filaments containing dna, enzymes and extracellular histones. netosis occurs in pregnancy and is increased in vascular-placental complications. it can be studied by measuring circulating histones, particularly the citrullinated histone h3. levels of this modified histone h3, as well as those of two other modifications, have recently been shown to increase during pregnancy. these levels have also been shown to be even greater in pregnancy complications. the aim of this study is to complete this mapping in order to obtain a precise signature for all post-translational histone modifications in normal pregnancies and pregnancies complicated by pre-eclampsia from the "grosspath" cohort in order to propose new circulating biomarkers for placental vascular pathologies. the post-translational histone modification profiles (mapping) of pregnant women with normal pregnancies will be compared with those developing pre-eclampsia.


Eligibility criteria:
inclusion criteria: * not applicable as this study is on samples from a biobank. the inclusion criteria for the "grosspath" cohort were: * pregnant women followed at nîmes university hospital for normal pregnancy or pregnancy with placental vascular pathology (pre-eclampsia and/or intra-uterine growth retardation). * the patient must have given her free and informed consent and signed the consent form. * the patient must be a member or beneficiary of a health insurance plan * only women are included * patients are at least 18 years old exclusion criteria: * not applicable as this is a study on samples from a biobank. the non-inclusion criteria of the "grosspath" cohort were : * twin pregnancies.

Keywords: pregnancy pre-eclampsia histones mass spectrometry neutrophils extracellular traps
screen to save: nci colorectal cancer outreach & screening initiative

Conditions: Colorectal Cancer

Summary: the purpose of this study is to provide educational materials and information regarding colorectal cancer (crc), crc screenings, and united states preventive services task force's (uspstf) screening recommendations. uspstf recommends screening for colorectal cancer starting at age 45 years and continuing until age 75 years.


Eligibility criteria:
inclusion criteria: * between 45 and 75 years of age * spanish or english speaking * able to provide informed consent * reside in the tampa bay area (namely hillsborough, pinellas, polk or pasco county) exclusion criteria: * does not meet inclusion criteria

Keywords: colon cancer cancer prevention
study of electroconvulsive therapy (ect) treatment for agitation and aggression in dementia

Conditions: Dementia; Aggression; Agitation

Summary: agitation/aggression is one of the most common and serious behavioral complications of dementia. if the behavior is refractory to standard care (behavior approaches and off label use of psychotropic medications), other evidence based treatment options are not currently available. retrospective reviews and preliminary studies have indicated electroconvulsive therapy (ect) may be a safe, effective intervention in this patient population. this study will measure the impact of open-label ect on symptoms of agitation, aggression, cognition, mood and psychosis for patients referred for ect who accept this intervention vs. those patients referred for ect but decline this intervention (i.e. standard care controls). it will also assess adverse events, activities of daily living and caregiver burden during study participation. the hypothesis is that subjects with dementia related aggression/agitation who receive ect will show significantly greater reductions in these behaviors than subjects who do not consent for ect and continue with standard care. pine rest is partnering with mclean hospital (massachusetts) to answer this question. to our knowledge, this is the first prospective study to examine whether patients receiving ect or standard care differ in reduction of aggression and agitation symptom severity and changes in cognition pre- and post- treatment.


Eligibility criteria:
inclusion criteria: * patients age 50 years or older from the older adult unit of pine rest christian mental health services or geriatric unit at mclean hospital * diagnosis of dementia according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria * mini mental status examination (mmse) score of 16 or greater * fluent in english * presence of agitation/aggression symptoms as defined by a minimum aggression score on the cohen-mansfield agitation inventory short version (cmai): a score of 4 or greater on at least one aggressive item, or a score of 3 on at least 2 aggressive items, or a score of 2 on at least 3 aggressive items, or 2 aggressive items occuring in frequency of 2 and 1 at frequency of 3. * a therapeutic decision will have already been made by the treating psychiatrist in consultation with the ect team to use ect treatment for agitation and aggression associated with dementia, with or without depression/mania. patients will be included in the ect treatment group if their legal representative consents to ect treatment. patients whose legal representative does not consent to ect treatment will be included in the standard care (non-ect) treatment group. * informed consent signed by authorized legal guardian and assent given by the participant * signed authorization for release of healthcare information by authorized legal guardian exclusion criteria: * current diagnosis of co-morbid delirium according to dsm-iv upon study entry * ect treatment within 90 days prior to study enrollment

Keywords: dementia aggression agitation
the evaluations of cardiovascular changes in long-term treated hiv-infected individuals

Conditions: HIV/AIDS; Cardiovascular Diseases

Summary: the present study aims to evaluate the cardiovascular changes in long-term virologically controlled hiv patients. all the participants have been treated and have been undetected for at least five years. vascular ultrasound and echo will be carried out at 0, 24, 48 and 96 weeks of follow-up.

previous studies have indicated that chronic hiv infection has resulted the diastolic cardiac dysfunction. in this study, 500 long-term virologically controlled hiv-infected individuals will be followed for two years, and evaluated at 0, 24, 48 and 96 weeks of follow-up. at each visiting point, ultrasound evaluation of carotid and vertebral arteries and the heart function will be carried out and compared.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * willingness and availability to engage in study activities for the duration of the study * age between 18-65 * documented hiv-1 infection (confirmed by western blot) * regular art treated for over 240 weeks * hiv-rna \< 200 cp/ml exclusion criteria: * pregnancy or breastfeeding or anticipated pregnancy in two years * history of aids-defining illness * virological failure during the art ( definition of virolgocial failure: plasma hiv-rna \> 200 cp/ml upon continuous harrt) * hemoglobin \< 9g/dl；or peripheral white blood cell counts \< 2000/μl；or neutrophil counts \< 1000 /μl；or platelet count \< 75,000/μl； * liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (uln), bilirubin level more than 2.5 times the uln) * chronic kidney disease (serum creatinine level more than 1.5 times the uln) * patients with a history of injection drug usage * patients with a history of mental disorders
the safety and efficacy of psilocybin in patients with treatment-resistant depression and chronic suicidal ideation

Conditions: Treatment Resistant Depression; Suicidal Ideation

Summary: this study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with trd and chronic suicidal ideation


Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age at screening * diagnosis of major depressive disorder (mdd) * significant level of suicidal thoughts with active ideation and without immediate intent * failure to respond to 2 medications in the current episode exclusion criteria: * current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc. * current alcohol or substance use disorder

Keywords: psilocybin psychedelic major depression treatment resistant depression suicidal ideation
a study to evaluate the effect of itraconazole on the pharmacokinetics of alisertib in participants with advanced solid tumors or relapsed/refractory lymphoma

Conditions: Advanced Solid Tumors; Relapsed/Refractory Lymphoma

Summary: this study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (pk) of alisertib.

the drug being tested in this study is called alisertib. alisertib is being tested in adult participants with advanced solid tumors or relapsed refactory lymphoma. the study will look at the effect of the pharmacokinetics (how the drug moves through the body) of alisertib in the presence and absence of itraconazole. this is an open label study. participants will receive: * alisertib tablets 30 mg in part a and 50 mg in part b * itraconazole oral solution 200 mg in part a participation in part a is approximately 25 days. part b participation is repeating 21-day cycles. the maximum duration of treatment with alisertib will be 12 months (approximately 16 cycles) unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. this multi-center study will take place in the united states.

Eligibility criteria:
inclusion criteria 1. male and female participants 18 years of age or older. 2. participants with histologic or cytologic diagnosis of advanced or metastatic solid tumors or lymphomas for which no curative or life-prolonging therapies exist. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria 1. systemic treatment with moderate or strong cyp3a inhibitors or inducers must be discontinued at least 14 days before the first dose of alisertib, and the use of these agents is not permitted during the study (except for the protocol-specified administration of itraconazole). 2. known gastrointestinal (gi) abnormality (including recurrent nausea or vomiting) or gi procedure that could interfere with or modify the oral absorption or tolerance of alisertib. 3. known hypersensitivity or intolerance to itraconazole or similar class agents.
safety evaluation of the rewalk restore device in subjects with mobility impairments due to stroke

Conditions: Stroke; Stroke, Acute; Stroke Hemorrhagic; Hemiparesis; Hemiplegia; Cerebrovascular Accident

Summary: a multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the rewalk restore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.


Eligibility criteria:
inclusion criteria: * history of one-sided ischemic or hemorrhagic stroke (\>2 weeks post stroke) * presentation of hemiparesis/hemiplegia resulting from stroke * at least 18 years of age * height of 4'8" - 6'7" * weight of less than 264 lbs * medical clearance by a clinician treating the subject * able to ambulate at least 5 feet without an ankle foot orthosis (afo), with no more than minimal contact assistance from a pt * able to follow a 3-step command * able to fit suit components (waistbelt, calf wrap) * no greater than 5 degrees of plantar flexion contracture during passive ankle rom * modified ashworth scale for spasticity at 3 or less for ankle dorsi-flexors and plantar-flexors exclusion criteria: * severe aphasia limiting ability to express needs or discomfort verbally or non-verbally * serious co-morbidities that, in the opinion of the investigator, may interfere with ability to participate * history of significant peripheral artery disease * colostomy bag * current pregnancy * uncontrolled or untreated hypertension * currently participating in any other ongoing clinical trial * presence of open wounds or broken skin at device locations requiring medical management * known urethane allergies * current medical diagnosis of dvt

Keywords: stroke exoskeleton hemiparesis hemiplegia
study on colonic fermentation in chronic kidney disease patients

Conditions: Renal Insufficiency, Chronic

Summary: chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. indirect findings suggest that chronic kidney disease influences the colonic microbial metabolism with higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. therefore, this study aims to elucidate the influence of renal dysfunction on microbial metabolism and to test the hypothesis that chronic kidney disease patients carry a different fecal metabolite profile.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 95 years * treatment with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more than 3 months * written informed consent exclusion criteria: * history of organic gastro-intestinal disease (e.g., inflammatory bowel disease, malignancy) * history of colonic surgery * recipient of a renal or other solid organ transplant * use of pre-/pro-/syn- or antibiotics in preceding 4 weeks
use of multiphoton microscopy in the diagnosis of cancer

Conditions: Bladder Cancer; Prostate Cancer

Summary: multiphoton microscopy (mpm) has been shown to be able to image tissue at a cellular level. our project will initially evaluated the ability of mpm imaging to distinguish normal bladder urothelium from atypical and malignant urothelium in the ex vivo setting. after development of sufficient criteria, we plan to develop an endoscopic bladder probe that will provide a non-invasive means to image the interior of the bladder at the cellular level, which would provide direct evidence of the presence of tumor without a biopsy. after exhibiting usefulness of mpm imaging for bladder cancer, we will look at other organs beginning with the colon.

same as above

Eligibility criteria:
inclusion criteria: * anyone who presents with bladder and/or prostate cancer

Keywords: bladder cancer prostate cancer multiphoton microscopy
trifecta™ durability study

Conditions: Aortic Valve Disease

Summary: the trifecta™ durability study was a multi-center, prospective, single-arm, post-market study conducted in europe and canada to collect long-term safety and performance data on the trifecta™ valve. the trifecta™ valve is a stented surgical aortic bioprosthesis with bovine pericardial leaflets designed for supra annular placement.


Eligibility criteria:
inclusion criteria: * patients implanted for less than 9 months with a trifecta™ valve, or patients who are candidates for implant with a trifecta™ valve, as per current guidelines * patient requires aortic valve replacement. * patient is legal age in host country. * patients must be able and willing to provide written informed consent to participate in this investigation * patients must be willing and able to comply with all follow-up requirements exclusion criteria: * patients with contraindication for cardiac surgery * patients who are pregnant. * patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits. * patient has active endocarditis * patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery. * patient is undergoing renal dialysis. * patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate. * patient has a documented thrombus in left atrium or left ventricle. * patient had in the past mitral or tricuspid valve replacement. * patient needs mitral and/or tricuspid valve replacement. * patient has an ejection fraction \< 25% * patient had the trifecta™ valve implanted as part of this study, but then had the device explanted * preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm. * patient has a life expectancy less than two years.