Kornimate/medical-research-clean huggingface dataset:
diversity and inclusion in research underpinning prevention and therapy trials

Conditions: Breast Cancer; Liver Cancer; Prostate Cancer

Summary: this proposal brings together multidisciplinary teams from four new york city institutions charged with reducing cancer disparities that affect approximately two million people residing in some of the most diverse and underserved communities in the united states. the intent of this collaborative research is captured by its acronym, disrupt: diversity \& inclusion in research underpinning prevention \& therapy trials. to disrupt the norms that maintain heightened risk and poorer outcomes experienced by bipoc, the research team propose three integrated and synergistic aims to improve diversity and inclusion in cts through disruptive approaches at the community (aim 1), provider, system and patient (aim 2), and basic and translational scientist levels (aim 3). all three aims focus on metrics for changing norms reified in institutional policies and established practice that will provide essential evidence to translate and scale these changes to institutions and networks involved in cancer treatment research. in aim 1, the research team will partner with local organizations to formulate and disseminate new norms regarding cancer care and research and diffuse these new norms throughout the community via community organizations and health ambassadors bringing a different vantage point on cts, raising awareness and increasing demand for access to cancer research. in aim 2, the research team will create an electronic approach to identify key clinical characteristics of patients and trials and match patients and trials and bring these data to patients and their physicians at the time of key decisions. in aim 3, the research team will provide and integrate essential experiential training in diversity, social determinants of health and the importance of conducting community-relevant work into basic and translational science training. this disrupt proposal provides the foundation to disrupt norms about cancer clinical trials in our communities, delivery systems and scientific research enterprises.


Eligibility criteria:
inclusion criteria: * all patients \>21 years of age with invasive breast, lung or liver cancer, who face a treatment decision * patients of doctors who have consented to participate * able to give consent and speak either english or spanish * for provider recruitment, oncologists, and advanced practitioners caring for patients with breast, lung, liver cancer including medical and surgical oncologists, interventional radiologists \& hepatologists will be eligible exclusion criteria: * patients who are unable to give consent * unable to understand english or spanish * lack of invasive breast/liver cancer * those who do not face an imminent treatment decision
comparison of pci in native arteries versus bypass grafts in patients with prior cabg (captain)

Conditions: Coronary Artery Disease

Summary: coronary atherosclerotic heart disease (cad) has been considered the leading cause of death in both developed and developing countries. coronary artery bypass grafting (cabg) is a major therapy of cad in the world, mainly used for patients with left main disease, multi-vessel complex disease, stent implantation failure, heart failure and diabetes. studies have demonstrated that significant angiographic defects up to 12% of grafts, which was observed by immediate coronary angiography after cabg. despite secondary prevention were performed in patients after cabg, the early failure rate at 1 year is higher, up to 15-20%, the 10-year patency rate of internal mammary artery graft is 85%, and the 10-year patency rate of saphenous vein graft is only 61%, and 10-20% of patients require revascularization within 10 years after cabg. patients with failed grafts usually have a higher surgical risk and the morality of repeat cabg is 2-4 times higher than primary surgery. because of the poor clinical prognosis of patients undergoing repeat cabg, pci is the preferred treatment strategy for revascularization in patients with previous cabg. in patients with previous cabg, approximately 75% of pci target vessels are native vessels. compared with native vessel pci, bypass graft pci has a higher rate of short- and long-term major adverse events, including more than double the in-hospital mortality rate. some studies support the above view，but others denied. therefore, the primary study mainly to explore the effect of native vessel pci or graft pci on the prognosis of patients with previous cabg.


Eligibility criteria:
inclusion criteria: * patients received first percutaneous coronary intervention in native arteries or in bypass grafts after coronary artery bypass grafting exclusion criteria: * patients who missed follow-up data were excluded

Keywords: coronary artery bypass grafting percutaneous coronary intervention coronary artery disease
symptom tracking in assisted reproductive technologies

Conditions: Depression Relapse in Women Undergoing Fertility Treatment

Summary: this study assesses risk factors for depressive relapse in women undergoing fertility treatment with histories of major depressive disorder (mdd) or bipolar disorder. the study is focused on the acute risk factors of depressive relapse. the investigators hypothesize that risk for depressive relapse will be greater among women who stop antidepressants compared to those who continue treatment with these agents.

this study hopes to address the following aims: specific aim #1: to delineate the relative risk of relapse in women undergoing ivf, iui, or other infertility treatments who discontinue antidepressant therapy for depression, compared to those who maintain treatment with these agents. hypothesis: risk for depressive relapse will be greater among women who stop antidepressants compared to those who continue treatment with these agents. specific aim #2: to identify predictors of depressive relapse among women receiving ivf, iui, or other infertility treatments hypothesis: relapse rates will be greater among those who have: 1) histories of more recurrent depressive illness, 2) longer duration of attempt to conceive, and 3) a lower degree of perceived support from respective partners. specific aim #3 (exploratory): to describe the trajectory of depressive symptoms in women with histories of depression across the course of ivf, iui, or other treatments. hypothesis: specific phases of the ivf cycle will have differential effects on the burden of depressive symptoms. specifically, these phases include: 1) the phase prior to egg retrieval, 2) the phase after embryo transfer while a woman waits for the pregnancy test or her menstrual period, and 3) the phase after the experience of a negative pregnancy test (when applicable) following an ivf cycle. we seek to characterize factors associated both with vulnerability to more depressive symptoms and to resilience in the context of the different phases of ivf treatment. specific aim #4 (exploratory): to identify biological markers of stress, including hpa axis dysregulation and inflammation associated with depressive relapse, during ivf, iui, or other infertility treatments hypothesis: hypothalamic-pituitary-adrenal (hpa) axis dysregulation, evidenced by increases in diurnal salivary cortisol patterns and markers of inflammation, will be associated with higher

Eligibility criteria:
inclusion criteria: * have a history of a mde or bipolar disorder prior to starting fertility treatment. * have received consultation around infertility treatment and plan to start fertility treatment. exclusion criteria: * use of corticosteroids within 1 month of enrollment. * presence of any endocrine or autoimmune disorder, other than hypothyroidism well-treated for at least 6 months. * current episode of depression or mania.

Keywords: infertility depression ivf iui fertility treatment
tigecycline in-vitro surveillance study in taiwan

Conditions: Community Acquired Infections

Summary: in-vitro surveillance study of tigecycline (tygacil) in taiwan.


Eligibility criteria:
inclusion criteria: * clinically relevant causative isolate (no duplicates) - the isolate must meet the laboratory criteria of "significant pathogen" and be considered the "probable causative agent" of a hospital or community acquired infection. * sources - all body sites are acceptable clinical sources for isolates to be included in this study (intra-abdominal infection, tracheal secretion/bronchoalveolar lavage, blood culture, wound smear). however, no more than 10 % of all isolates can come from urine cultures. * within study group - only isolates defined by the protocol are to be included. exclusion criteria: * limited isolates from sources - no more than 10 % of all isolates from this study will be derived from urine cultures. * no banked or stored isolates. * no duplicate isolates - only one isolate per patient is permitted. * outside study group - any isolate other than those defined by protocol.

Keywords: tygacil microdilution method tigecycline in-vitro
prime hfref: novel exercise for older patients with heart failure with reduced ejection fraction

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: this study is trying to find out whether performing a hybrid aerobic-resistance exercise training program (titled prime: peripheral remodeling via intermittent muscular exercise) results in better health outcomes than the traditional exercise training program (called combo) that is used in individuals with heart failure with reduced ejection fraction (hfref). participants will be randomized (like the flip of a coin) to either prime (investigational) or the traditional exercise program (standard of care).

this study is a two-arm, prospective randomized clinical trial with participants randomized, in a 1:1 ratio to 4 weeks of either standard progressive whole-body aerobic plus resistance training (combo) or prime training (phase 1), followed by 8 weeks of progressive whole-body combo assigned to all participants (phase 2). the objective of this study is to determine whether prime exercise training can outperform traditional (combo) exercise training to improve outcomes in hfref patients. the study aims to test 92 hfref patients (46 randomized to prime and 46 to combo training) over a 5-year period. data will be collected at each visit and patients will return for a 6-month follow up from the date of the final visit.

Eligibility criteria:
inclusion criteria: * subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. * subjects may be of either sex with age \> 65 years. * subjects must be diagnosed with hfref as per established echocardiographic criteria (new york heart association class ii-iii) with an ejection fraction \<45%. * cardiologist approve after thorough chart review and physical examination * hemoglobin of at least 10.0 g/dl exclusion criteria: * progressive worsening of exercise tolerance or dyspnea at rest or on exertion over previous 3-5 days * significant ischemia at low exercise intensities (\<2 mets or \~50 w) * uncontrolled diabetes (hba1c \>10%) * acute systemic illness of fever * recent embolism (in the 6 weeks) * deep vein thrombophlebitis * active pericarditis or myocarditis * severe aortic stenosis (aortic valve area \<1.0 cm2) * regurgitant valvular heart disease requiring surgery * myocardial infarction within previous 3 weeks * new onset atrial fibrillation (in the last 4 weeks) * resting heart rate \>120bpm

Keywords: hfref vo2peak
efficacy basics of bihemispheric motorcortex stimulation after stroke

Conditions: Stroke; Hemiparesis

Summary: the aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tdcs) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. results will be compared to a matched group of patients undergoing anodal tdcs as well as a control group receiving sham tdcs. functional and structural magnetic resonance imaging (mri) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.


Eligibility criteria:
inclusion criteria: * chronic stroke (\>6 months after stroke) * age: 18 to 80 years * non-hemorrhagic or hemorrhagic stroke exclusion criteria: * more than 1 stroke * severe alcohol disease or drug abuse, severe psychiatric disease like depression or psychosis * severe cognitive deficits * severe untreated medical conditions * other neurologic diseases * severe microangiopathy * pregnancy

Keywords: stroke hemiparesis tdcs motor cortex
multicentric analysis of predictors of n1 upstaging after resection of cstage-i nsclc

Conditions: Non Small Cell Lung Cancer

Summary: five papers showed a lower n1 nodal upstaging with video-assisted thoracic surgery (vats) compared to open surgery in patients with cstage-i nsclc . this finding questions the oncologic quality of minimal invasive lung cancer surgery, especially the quality of hilar and intrapulmonary lymh node dissection. however, these retrospective studies did not include analysis of central tumor location, although central tumors have a reported higher chance of n1 upstaging . possibly, this creates a selection bias as surgeons might select central lesions deliberately for open surgery in line with initial vats feasibility reports

after optimal preoperative staging, 10 to 25% of patients with clinical stage i (cstage-i) non-small cell lung cancer (nsclc) are found to have unforeseen positive lymph nodes during resection. central tumors, even if they are smaller than 3cm (ct1), have a higher incidence of both intrapulmonary or hilar (n1) or ipsilateral mediastinal (n2) lymph node involvement in comparison to peripheral lesions. in a cohort of patients that underwent identical preoperative mediastinal evaluation and postoperative pathologic tissue examination of equal quality, nodal upstaging can be used as a quality indicator of oncologic thoracic surgery. or, it can be used as an instrument to compare different techniques, such as thoracoscopic (vats) versus open lung resections for lung cancer. five papers showed a lower n1 nodal upstaging with video-assisted thoracic surgery (vats) compared to open surgery. these retrospective studies did not include tumor location. the investigators hypothesize that this creates a bias as surgeons might have chosen an open approach when the tumor was centrally located. this is in line with initial feasibility reports and guidelines that excluded patients with central lesions. this results in a higher prevalence of positive n1 nodes in patients operated with the open approach. our single centre analysis showed a one in three chance of nodal upstaging in central located cstage-i tumors , multivariate analysis showed central location to be the only significant predictor for upstaging, and not the surgical technique. the aim of this multicentric study is to investigate risk factors for nodal upstaging, including tumor location, in patients with cstage-i nsclc and validate previous findings.

Eligibility criteria:
inclusion criteria: * patients operated in 2014 * nsclc on final pathology * cstage-i (ct1-2a cn0 cm0 ) before start of incision for anatomical resection. * this includes: open/vats/ robotic assisted thoracoscopic surgery (rats) * this includes: lobectomy, bilobectomy, sleeve or pneumonectomy (not wedge) exclusion criteria: * higher clinical stage than cstage-i * former therapy for lung cancer (chemotherapy, radiotherapy, surgery) * metastatic disease * induction chemo- or radiotherapy * non-anatomical resections (wedge) * previous lymph node disease * no positron emission tomography (pet) or missing pet report

Keywords: surgery thoracotomy vats
loteprednol etabonate ophthalmic gel for the treatment of ocular inflammation and pain following cataract surgery

Conditions: Inflammation; Pain; Cataract

Summary: the objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (le) ophthalmic gel, 0.38% (bid)

the objective of this study is to evaluate the safety and efficacy of loteprednol etabonate (le) ophthalmic gel, 0.38% (bid) for the treatment of inflammation and pain following cataract surgery.

Eligibility criteria:
inclusion criteria: visit 1 (screening visit) * be willing and able to comply with all treatment and follow-up/study procedures. * be a candidate for routine, uncomplicated cataract surgery. visit 3 (postoperative day 1) * have undergone routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens (iol) implantation, not combined with any other surgery) in the study eye. * have ≥ grade 2 anterior chamber (ac) cells (6-15 cells) in the study eye. exclusion criteria: * have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or confound the result(s) of the study. * have known hypersensitivity or contraindication to the study drug(s) or their components.
a pilot study of trv130 for the treatment of fracture pain

Conditions: Pain

Summary: the primary objective is to evaluate the analgesic efficacy of trv130 for moderate to severe acute pain in patients presenting to the emergency department (ed) with a suspected/known, unilateral, closed long bone fracture.

this study is designed to evaluate the analgesic efficacy of trv130 for the treatment of moderate to severe acute pain associated with a long bone fracture in patients presenting to the ed. the safety and tolerability of trv130 will also be evaluated in this open-label pilot study.

Eligibility criteria:
inclusion criteria: * age 18-65 years, inclusive * has a suspected/known, unilateral, closed fracture of either: radius, ulna (or both) or tibia, fibula (or both) but not fractures in more than 1 extremity * able to understand and comply with study procedures and requirements, and provide written informed consent exclusion criteria: * significant concomitant head, chest, or abdominal trauma * multiple extremity trauma * open fracture * clinically significant medical condition or history of such condition that may place the patient at an unacceptable risk in the trial, may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs

Keywords: pain long bone fracture
arsenic trioxide in treating patients with refractory or recurrent acute promyelocytic leukemia

Conditions: Leukemia

Summary: the purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic trioxide in the treatment of patients with relapsed or refractory acute promyelocytic leukemia (apml). in addition, correlation between pharmacokinetic data and both therapeutic response and therapy-related toxicities will be sought.

outline: this is a dose-escalation study. patients receive arsenic trioxide iv over 2 hours daily for 28 days followed by a 14 day rest period. patients may receive up to 3 courses of treatment. dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose (mtd) or minimum effective dose (med) is determined. the mtd is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. the med is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response. after the mtd or med is determined, an additional 20 patients are enrolled at this dose level. patients are followed monthly for 6 months and every three months for an additional 1.5 years.

Eligibility criteria:
inclusion criteria 1. apml diagnosis based upon morphological, histochemical, and/or flow cytometric criteria, confirmed upon review by a central, study-designated hematologic pathologist; or any relapsed acute leukemia bearing a t(15:17) translocation or variant apml translocations involving the retinoic acid receptor alpha gene on chromosome 15q22, based on cytogenetics or pcr. 2. disease in first or subsequent relapse, following standard induction and consolidation chemotherapy (with all-trans retinoic acid) and/or allogeneic bone marrow/stem cell transplantation; or failure to achieve initial complete remission with atra and standard chemotherapy. exclusion criteria 1. availability of a fully hla-matched sibling donor for patients otherwise felt to be candidates for allogeneic bone marrow/stem cell transplantation; patients with only a partially hla-matched sibling or matched unrelated donor will remain eligible for study entry. 2. pregnancy. 3. patients with significantly impaired left ventricular ejection fraction (\<40%) will be ineligible for the study. patients with renal failure and a creatinine clearance of less than 25 ml/min or requiring hemodialysis will be ineligible for the study. otherwise, there are no rigid exclusion criteria based upon age, performance status, or co-morbidity. decisions regarding enrollment of patients for whom these factors may be relevant will be individualized and left to the discretion of the investigators. central venous access will be required for all patients. patients of child-bearing potential must agree to use contraception during sexual intercourse while undergoing treatment with arsenic trioxide.

Keywords: recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia adult acute promyelocytic leukemia (m3) childhood acute promyelocytic leukemia (m3)