Kornimate/medical-research-clean huggingface dataset:
prior cabg patients evaluated for saphenous vein graft dysfunction and progression of coronary artery disease

Conditions: Recurrent Angina After Coronary Artery Bypass Graft; Graft Failure; Coronary Artery Disease Progression

Summary: this is a multi-center, observational cohort study including patients with prior coronary artery bypass grafting (cabg) and ≥1 saphenous vein grafts (svg) presenting with recurrent ischemic symptoms. objective: to investigate the clinical outcomes in patients with prior cabg evaluated for bypass graft failure and progression of native coronary artery disease (cad). follow-up will be collected through national registry databases, electronic medical patient records and standardized telephonic assessment at 3 and 5 years follow-up.

despite advances in secondary prevention, a wide variety of vascular grafts available, and evolving surgical techniques, long-term efficacy of cabg is hampered by bypass graft failure and native cad progression. therefore, patients with prior cabg often present with recurrent ischemic symptoms. indeed, many prior cabg patients undergo repeat cardiac catheterization and require subsequent revascularization therapy. the clinical evaluation and diagnostic work-up of patients with recurrent angina after cabg is challenging. patients with previous cabg are generally older, have a higher prevalence of cardiac risk factors and comorbidities, more extensive cad, and complex atherosclerotic lesion morphology. furthermore, current guideline recommendations on patient management are limited since post-cabg patients have often been underrepresented or excluded in large diagnostic and revascularization trials. this registry will include patients presenting with recurrent ischemic symptoms with a history of cabg and ≥1 svgs that are referred to the amsterdam university medical centers. patients will be eligible for inclusion in the viaduct registry after consideration of in- and exclusion criteria. subsequently, patients will be approached for study participation. patients are free to refuse or to withdraw from participation in the registry at any moment. the primary objective is to investigate clinical outcomes in patients with recurrent symptoms who are evaluated for bypass graft failure and native cad progression. in addition, results from non-invasive and invasive diagnostic tools that are used during clinical work-up to assess graft patency, the hemodynamic significance of native cad progression, left ventricular function, and myocardial viability will be collected. we aim to evaluate the value of such tools to guide optimal repeat revascularization strategy.

Eligibility criteria:
inclusion criteria: * prior coronary artery bypass grafting * one or more saphenous vein grafts * recurrent angina symptoms exclusion criteria: * \<18 years of age * ≥ 90 years of age * cardiogenic shock * pregnancy * failure to provide informed consent

Keywords: coronary artery bypass grafting recurrent angina saphenous vein graft dysfunction advanced coronary artery disease
comparative efficacy study to demonstrate the non-inferiority of i-drop® mgd versus 2 competitor eye drops in managing evaporative dry eye

Conditions: Evaporative Dry Eye Disease

Summary: a pilot comparative study between i-drop mgd vs two commercially available lubricant eye drops for the management of evaporative dry eye

pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of i-drop mgd vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye

Eligibility criteria:
inclusion criteria: * is at least 18 years of age and has full legal capacity to volunteer. * has read and signed an information consent form. * is willing and able to follow instructions and maintain the appointment schedule. * has dry eye disease as per the tfos dews ii definition with a clear moderate to severe evaporative dry eye: * osdi ≥ 13 * and tbut \< 10 seconds * and \>5 spots of corneal fluorescein staining or \> 9 conjunctival spots * meibomian gland score of 1 or higher using nei grading criteria. exclusion criteria: * is participating in any concurrent clinical or research study. * is wears contact lenses. * is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin a analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity. * has undergone eye surgery involving the cornea or conjunctiva. * aqueous deficient ded patients. * is currently or has used any of the study drops in the last 3 months. * has any known allergy or intolerance to any of the study drops. * has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable * has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease). * has known sensitivity to sodium fluorescein. * is pregnant, lactating or planning a pregnancy at the time of enrolment? * unwilling to stop using their habitual artificial tears for the study. * has been fitted with punctal plugs within 30 days before the study screening visit. * contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.

Keywords: dry eye disease lubricant eye drops meibomian gland dysfunction evaporative dry eye
zeroheart biopsy - prediction of deceased donor heart transplant performance from organ donors using pre-transplant biopsies - a pilot study

Conditions: Heart Transplantation; Graft Rejection; Myocardial Injury; Organ Preservation; Biopsy; Gene Expression Profiling

Summary: the goal of this observational study is to evaluate whether molecular analysis of donor heart biopsies taken at the time of organ removal ("time zero") can help predict the future function and rejection risk of the transplanted heart in adult transplant recipients. the main questions it aims to answer are: * can early molecular injury in the donor heart, caused by brain death or circulatory death, be detected at the time of organ removal? * can these early molecular findings predict short-, mid-, and long-term transplant outcomes, such as graft function or rejection? participants will: * include heart donors whose hearts are being transplanted (both standard and marginal donors, including dbd and dcd cases) * provide two small biopsies from the donor heart at the time of organ removal: one for routine pathology, one for microarray-based molecular analysis * have routine follow-up biopsies after transplantation as part of standard care (no additional procedures required beyond medical standard) researchers will compare biopsy results from different donor types (standard vs. marginal, dbd vs. dcd) to see if early molecular signals are linked to later heart transplant outcomes.


Eligibility criteria:
inclusion criteria: all hearts from standard and expanded criteria donors as well as donor hearts from donation after circulatory death (dcd) undergoing a heart biopsy at pre-implantation (at procurement) will be included. consent will be obtained from the recipient at the time of transplant listing. exclusion criteria: hearts will be excluded from the study if the participating clinician decides to discard the organ before transplantation or the recipient declines that the biopsy will be performed at the organ procurement.
characterizing sleep among long-term survivors of childhood cancer

Conditions: ALL, Adult; CNS Tumor; Solid Tumor

Summary: the patients are being asked to take part in this clinical trial because they received cancer treatment as a child at st. jude. the study comprehensively examines sleep among three distinct diagnostic groups of survivors in the sjlife cohort: all, cns tumors, and non-cns solid tumors. primary objective the primary aim of this protocol is to estimate the prevalence of various sleep disorders among long-term survivors of childhood all, cns tumors, and non- cns solid tumors. exploratory objective the exploratory objective of the study is to explore associations between the prevalence of sleep disorders and clinical outcomes collected in sjlife.

a cross-sectional pilot study that will enroll participants for on-campus or remote study activities. the investigators anticipate a targeted evaluable accrual of 120, 40 within each of the three groups identified above. the plan is to employ remote polysomnography and surveys to assess patterns of sleep disorders. these assessments could be done in the homes of survivors or during campus visits.

Eligibility criteria:
inclusion criteria: * participant in sjlife and \> 5 years from diagnosis. * \>18 years of age at time of enrollment. * diagnosed with all (treated with crt or chemotherapy only) or cns tumors (posterior fossa tumors or supratentorial tumors) or non-cns solid tumors (with abdominal or chest radiation or bilateral retinoblastoma survivors). * participant was less than 21 years of age at time of diagnosis. * speaks and understands english (polysomnography device speaks to patients only in english). * remote participant must have wi-fi access exclusion criteria: * estimated intelligence score \<80. * currently prescribed an intervention for a sleep disorder. * survivor of craniopharyngioma. * survivor of hodgkin lymphoma. * relapsed or treated with hematopoietic stem cell therapy. * brain injury unrelated to cancer diagnosis or therapy. * pulmonary injury unrelated to cancer diagnosis or therapy.
pilot study of the feasibility of multicenter nirs data collection and interventions for desaturation in cardiac surgery

Conditions: Cardiac Disease

Summary: using the 9 centers (appendix b) involved with the planned multicenter nirs comparative effectiveness trial the specific aims of this study are: 1. to demonstrate the feasibility of collecting rsco2 data from patients undergoing cardiac surgery in a multicenter study design. 2. to demonstrate the feasibility of using a standard algorithm for treating rsco2 desaturations during cardiac surgery in a multicenter study design.

brain injury after cardiac surgery is a chief source of patient mortality and healthcare costs and can significantly impair quality of life. reducing the burden of this complication has wide public health implications. the broad manifestations of perioperative brain injury include stroke, delirium, and cognitive decline.5 all forms of injury are believed to result primarily from cerebral embolism and/or reduced cerebral blood flow (cbf). the risk for cerebral hypoperfusion is likely the highest during cardiopulmonary bypass (cpb), when mean arterial pressure (map) is kept low (\~60 mmhg), particularly for patients who are aged and who have cerebral vascular disease. near-infrared spectroscopy (nirs) is used increasingly to monitor regional cerebral oxygen saturation (rsco2) in patients undergoing cardiac surgery, although limited data show that it improves patient outcomes. regardless, clinical evidence supporting the efficacy of nirs-based monitoring is needed urgently because the cost of nirs sensors (\~$220/patient) could add $132 million annually to hospital costs for cardiac surgery. we must address this issue quickly because the rising prevalence of nirs use and advocacy by experts and industry will likely soon result in nirs becoming a standard of care. we are in the process of submitting a multicenter, prospectively randomized comparative effectiveness trial to assess the efficacy of nirs monitoring in patients who are undergoing coronary artery bypass graft (cabg) surgery with cpb, and/or valve surgery, and who are at risk for brain injury. the goal of the planned proposal is to determine whether interventions to correct rsco2 desaturations (value \<50% or 20% reduction from room air baseline) reduce the frequency of neurologic and other complications compared with standard care (no clinical monitoring). in order to demonstrate feasibility of our proposal we need to demonstrate the ability of the team to collect rsco2 data from multiple centers and to show the ability of the team to properly follow an algorithm for treating rsco2 desaturations that occur during surgery. thus, the aim of the current study is to collect preliminary data to support our larger comparative effectiveness trial.

Eligibility criteria:
inclusion criteria: patient inclusion criteria will be male or female patients \>50 years of age undergoing primary or re-operative cabg and/or cardiac valve surgery that requires cpb who will have nirs monitoring for clinical indications. - exclusion criteria: emergency surgery -

Keywords: cardiac surgery; near infrared spectroscopy
expanded access study for renal transplant patients with envarsus xr ™

Conditions: Renal Failure

Summary: open label, multi-center, expanded access study for renal transplant patients with once daily envarsus xr (tacrolimus).

the study is designed to facilitate expanded access of envarsus xr treatment to renal transplant patients. patients are identified by the site investigator as a patient who has experienced favorable outcomes while in an envarsus xr (lcp-tacro) clinical study and/or the site investigator has identified a renal transplant patient with a medical need for an alternative tacrolimus treatment versus the patient's current tacrolimus treatment.

Eligibility criteria:
inclusion criteria: * eligible patients will fulfill all of the following criteria: 1. patient age ≥18years old 2. willing to give written informed consent and is able to speak, write and understand english 3. patient understands potential risks or benefits with treatment of envarsus xr 4. patients who have received a primary or secondary kidney transplant 5. patient who have received prior treatment with envarsus xr (lcp-tacro) and who are not currently participating in an envarsus/lcp-tacro study or 6. the treating investigator has identified the patient as having a medical necessity for switching from their current tacrolimus treatment to envarsus xr: investigator is aware the medical necessity for switching is not related to the inability to purchase available tacrolimus. exclusion criteria: * patients fulfilling any of the following criteria are not eligible for study inclusion: 1. recipients of organ transplants other than kidney 2. pregnant or nursing (lactating) women, or planning to become pregnant, where pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive hcg serum or urine laboratory test. 3. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined soc method of contraception, unless they are * women whose career, lifestyle, or sexual orientation preclude intercourse with a male partner * women whose partners have been sterilized by vasectomy or other medically approved means
frequency of prostate-specific antigen screening in african american men in the san francisco area

Conditions: Prostate Cancer

Summary: rationale: screening may help doctors find prostate cancer sooner, when it may be easier to treat. purpose: this research study is looking at whether patients who are being screened for prostate cancer have been previously screened.

objectives: primary * to determine the degree to which patients who are being screened for prostate cancer have been previously screened. outline: participants complete questions on a survey about prior prostate-specific antigen blood tests done for the purpose of screening for prostate cancer and are asked about their pastor, church, and how they heard about the select study to determine the degree to which african-american men in a church-going population have been previously screened.

Eligibility criteria:
disease characteristics: * meets all of the following criteria: * african-american male * age 35 years or older * attends church on a regular basis * resides in the san francisco area patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: prostate cancer
laser versus silver diamine fluoride in hall technique in primary teeth

Conditions: Carious Teeth

Summary: the hall technique for primary teeth depends on the idea of isolation of the carious non exposed primary tooth from all bacteria present in the oral cavity by using a stainless-steel crown which result in arresting of the caries and preventing its progress to the pulp. recently laser and silver diamide fluoride (sdf) have been used to arrest the progress of caries so in the current study we will compare the success rate of hall technique with either laser or sdf in arresting of caries

the high frequency of caries in primary teeth and its inadequate treatment are major public health problems during childhood. nowadays, the hall technique is one of the methods used for biological sealing in carious lesions in primary molars. thus, the bacteria will be sealed from oral environment and the caries will be inactive. using the hall technique, the crown is placed without local anesthesia, caries removal, or tooth preparation. then, the crown is fitted over the carious primary molar by either the dentist's finger pressure, or the child's biting force. the average results of many clinical trials showed that the success rates of the hall technique were greater than the conventional restorations. however, some criteria of minor failures were seen in 26.6% of hall crowns. silver diamine fluoride (sdf), a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children, its effectiveness in reducing specific cariogenic bacteria and its remineralizing potential on enamel and dentin have been reported in many studies. recently, lasers have been proven to significantly arrest the dental caries by increasing the acid resistance of the enamel with an antibacterial effect. diode lasers with several positive aspects, such as the small size, low cost, and ease of use in the oral cavity, were found to have a caries prevention and arrest effect on the dental enamel, particularly deciduous teeth. in the current study the success rate of hall technique using sdf will be compared to the same technique using diode laser in arresting the carious lesions in primary teeth.

Eligibility criteria:
inclusion criteria: * patients should be medically free * presence of asymptomatic enamel and dentin caries in one or more primary molars, which can be detected clinically and radiographically * periapical radiograph should show caries involving the outer half of the dentin * there should be no signs or symptoms of pulpal pathosis exclusion criteria: * immunocompromised patients * presence of any signs or symptoms of pulpal pathosis denoting irreversible pulpitis * parents who are not willing to come in the follow up visits
registry - use of a high intensity focused ultrasound (hifu) in patients with non-malignant thyroid nodules.

Conditions: Non-malignant Thyroid Nodule

Summary: the purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following hifu therapy assessed by ultrasonography

hifu treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist. a maximum of 2 hifu sessions per nodule will be performed per patient. the decision to retreat the patient will be taken at 1 month post-hifu or later. follow-up after hifu treatment d1 after hifu session: * indirect laryngoscopy to check vocal cord mobility. d7 after hifu session * clinical examination (skin, local symptoms, oedema, voice....), * ultrasonography and power doppler, m1 after hifu session * clinical examination (skin, local symptoms, oedema, voice....), * ultrasonography and power doppler, m3 after hifu session * clinical examination (skin, local symptoms, oedema, voice....), * ultrasonography and power doppler decision for an additional hifu course to improve volume reduction. in case of a second hifu session d7b, m1b and m3b, m6b, m9b, m12b, m18b, m24b and m36b will be performed m6 after last hifu session * clinical examination (skin, local symptoms, oedema, voice....), * ultrasonography and power doppler * tsh * free t4 * antithyroid peroxidase antibodies * calcemia and pth (in case of bilateral treatment or in case previous thyroid surgery) m9 after hifu session * clinical examination (skin, local symptoms, oedema, voice....), * ultrasonography and power doppler m12 after last hifu session * clinical examination (skin, local symptoms, oedema, voice....), * ultrasonography and power doppler * tsh * free t4 * antithyroid peroxidase antibodies * calcemia and pth (in case of bilateral treatment or in case previous thyroid surgery) m18, m24, m36 after hifu session * clinical examination (skin, local symptoms, oedema, voice....), * ultrasonography and power doppler

Eligibility criteria:
inclusion criteria: * male or female patient 18 years or older. * patient presenting with at least one thyroid nodule with no signs of malignancy: 1. non suspect clinically and at ultrasonography imaging 2. benign cytological diagnosis at fnab from the last 6 months 3. normal serum calcitonin 4. no history of neck irradiation * normal tsh. * targeted nodule accessible and eligible to hifu * absence of abnormal vocal cord mobility at laryngoscopy. * nodule diameter ≥ 10mm measured by ultrasound. * composition of the targeted nodule(s) : no more than 30% cystic exclusion criteria: * head and/or neck disease that prevents hyperextension of neck. * known history of thyroid cancer or other neoplasias in the neck region. * history of neck irradiation. * macrocalcification inducing a shadow in the thyroid significant enough to preclude the hifu treatment * posterior position of the nodule if the thickness of the nodule is \<15mm * pregnant or lactating woman * any contraindication to iv neurolept analgesia.