Kornimate/medical-research-clean huggingface dataset:
deferoxamine for iron overload before allogeneic stem cell transplantation

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome

Summary: the objective of this research study is to determine the safety and feasibility of chelation therapy with deferoxamine for patients with iron overload who are receiving a stem cell transplant. patients who have iron overload prior to stem cell transplantation may have more toxicity from the transplantation procedure, and thus may benefit from an attempt at iron chelation pre- and peri-transplantation. in this study we are examining the use of deferoxamine starting 2 weeks to 3 months prior to transplantation and continuing through the preparative regimen.

see above

Eligibility criteria:
inclusion criteria: * 18 years of age or older * histologically confirmed acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome * planned allogeneic stem cell transplantation with myeloablative conditioning regimen; the planned date of transplantation must be at least 4 weeks from time of enrollment * severe iron overload as defined by both: ferritin greater than 1000ng/ml (at the time of donor availability) and liver iron content estimated greater than or equal to 5mg/g dry weight by mri (at the time of donor availability) * patients with a history of prior autologous transplantation will be eligible for this study exclusion criteria: * contraindication to magnetic resonance imaging (mri) * creatinine \>2.0mg/dl or creatinine clearance \<50ml/min * active uncontrolled bacterial or fungal infection * history of mucormycosis * pre-existing clinically apparent retinal neuropathy. if patients have clinically apparent visual loss at the time of screening, they will be excluded if either they have known retinal neuropathy or if this cannot be excluded by further testing * pre-existing clinically apparent sensorineural hearing loss. if patients have auditory loss at the time of screening, they will be excluded if either they have known sensorineural hearing loss, or if this cannot be excluded by further testing * pregnancy or inability or unwillingness to use contraception during the time of the study * lactating patients * inability to provide informed consent

Keywords: aml all mds iron overload deferoxamine
the impact of adverse events, produced by antibodies conjugates, on quality of life in patients with metastatic breast cancer: multicentric, observational study (eva).

Conditions: Metastatic Breast Cancer

Summary: the study stems from the need to detect adverse events arising after the administration of antibody-drug conjugates (adcs) used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.

the study stems from the need to detect adverse events arising after the administration of adcs used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.through the findings of toxicities related to the adcs, it will be possible to highlight which are the issues that most affect patients undergoing these cancer treatments. the analysis of the data collected will also make it possible to highlight any toxicities not yet considered or/and of new onset. in addition useful elements may emerge from responses to the quality of life questionnaire, to cope with the difficulties expressed by patients regarding daily life activities, social relations, work and family. such contributions will be fundamental to the construction of integrated care pathways, the aim of which is to involve a specialized nurse as part of a multidisciplinary team.

Eligibility criteria:
inclusion criteria: * female gender; * age ≥ 18 years; * signature of consent to participate in the study and to the processing of personal data (privacy); * diagnosis of stage iv breast cancer; * systemic treatment with t-dm1, t-dxd or sg as monotherapy; * absence of cognitive decline, expressed by a score greater than or equal to 4 on the six item screener questionnaire; * good understanding of the italian language; * willingness and ability to adhere to scheduled visits, treatment plan, laboratory tests and study procedures. exclusion criteria: * all patients who do not meet the above criteria will be excluded from the study.
tele-health electronic monitoring to reduce post discharge complications and surgical site infections

Conditions: Peripheral Vascular Disease

Summary: abstract: it is intuitive that post discharge surgical complications are associated with increased patient dissatisfaction, and directly associated with an increase in medical expenditures. it is also easy to make the connection that many post hospital discharge surgical complications including surgical site infections could be influenced or exacerbated by patient co-morbidities. the authors of a recent study reported that female gender, obesity, diabetes, smoking, hypertension, coronary artery disease, critical limb ischemia, chronic obstructive pulmonary disease, dyspnea, and neurologic disease were all of among significant predictors of surgical site infections after vascular reconstruction was performed. the main concern for optimal patient care especially in geographically isolated areas of west virginia is to have early, expeditious, and prompt diagnosis of early surgical site infection with subsequent indicated interventions. this theme will lead to patient satisfaction, minimizing third party interventions and decrease the total cost associated with these complications. nevertheless, it seems reasonable to believe that monitoring using telehealth technology and managing the general health care patients receive after a hospital vascular intervention will improve overall health and reduce post-operative complications. aims/objectives: 1. the primary objective of the current project is to compare early and late outcomes for patients who receive post discharge health care monitoring (which includes using telehealth electronic monitoring; them) to patients who receive standard of care (soc) and routine discharge instructions and no monitoring. methods: 1. randomize patients who are scheduled to have revascularization interventions with groin incisions to receive either telehealth electronic health care monitoring or normal standard of follow-up care. 2. follow patients for 4 weeks, record any 30-day hospital readmissions or complications. in addition, have participants complete the follow-up survey questionnaires.


Eligibility criteria:
inclusion criteria: 1. patients with any planned vascular procedures with cut-down access to the groin and treated by one of the charleston area medical center -vascular surgeons in the vascular center (vcoe) will be consented and enrolled. exclusion criteria: 1. do not plan to do follow-up visit at the vcoe; 2. history of dementia; 3. do not have home internet service with wifi or live outside of the provided cell coverage area (cell coverage will be provided for patients without internet wifi).

Keywords: surgical site infection
a comparison between ketamine-lidocaine versus ketamine-fentanyl for induction on the hemodynamic effects in patients with coronary artery disease

Conditions: Induction of General Anesthesia

Summary: patients with coronary artery disease (cad) and left ventricular systolic dysfunction (lvsd) presenting for coronary artery bypass grafting (cabg) represent a high-risk group among the cardiac surgical population. anesthetic management of these patients is challenging due to increased risk of perioperative hypotension and subsequently increased risk of postoperative morbidity and mortality. post induction hypotension is a modifiable risk that can be largely prevented by adjusting the technique for anesthesia induction. there is no consensus on the use of certain anesthetic induction techniques for patients cad and left ventricular dysfunction. anesthesia induction techniques for cardiovascular surgery are usually based on considerations such as hemodynamic stability, effects on myocardial oxygen supply, and demand and minimizing intubation stress response.to the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with ketamine in patients with poor ventricular function.


Eligibility criteria:
inclusion criteria: * participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction \< 40%), asa physical status ii-iv that will be scheduled for elective cabg surgery. exclusion criteria: * patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (iabp), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study
proteolytic enzyme induction within the human myocardial interstitium

Conditions: Heart Disease

Summary: a robust release of endothelin-1-1 (et) with subsequent eta subtype receptor (et-ar) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (cpb). increased et-ar activation has been identified in patients with poor left ventricular (lv) function (reduced ejection fraction; ef). accordingly, this study tested the hypothesis that a selective et-ar antagonist (et-ara) administered peri-operatively would favorably affect post-cpb hemodynamic profiles in patients with a pre-existing poor lvef.

patients with a reduced lvef were prospectively randomized, in a blinded fashion, at the time of elective coronary revascularization and/or valve replacement requiring cpb, to infusion of the highly-selective and potent et-ara, sitaxsentan at 1 or 2 mg/kg (iv bolus) or vehicle (saline). infusion of the et-ara/vehicle was performed immediately prior to separation from cpb and again at 12 hrs post-cpb. et and hemodynamic measurements were performed at baseline, at separation from cpb (time 0) and at 0.5, 6, 12, 24 hrs post-cpb.

Eligibility criteria:
inclusion criteria: * \>60 years of age * body mass index \<40 kg/m2 * left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram * patients undergoing coronary artery bypass (cabg), aortic and/or mitral valve replacement or combined cabg and valve procedures requiring cpb. * if diabetic, be under proper control, (fasting glucose \<350 mg/dl or recent hemoglobin a1c \[hgba1c\] \<9%). * if hypertensive, be on a stable medical regimen with no significant changes over the past 30 days. * female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years * the patient is an appropriate study candidate as determined by the investigator on the basis of medical history and physical examination exclusion criteria: * emergent revascularization * previous stroke or thrombo-embolic event in the 3 months prior to study entry * a previous myocardial infarction within the last 7 days * documented coagulopathy * hepatic dysfunction as defined by aspartate transaminase (ast) or alanine transaminase (alt) \> 1.5 times the upper limit of normal * patient is pregnant or breastfeeding
trans-resveratrol's influence on the development of chf in early postmenopausal women with htn and reduced bmd

Conditions: Heart Failure; Arterial Hypertension; Osteopenia; Menopause

Summary: 1. to measure the ability of trans-resveratrol to influence the development of chronic heart failure (chf) in women in the early postmenopausal period (1-4 years) with hypertension (htn) and reduced bone mineral density (bmd). 2. to evaluate the safety of long-term use of trans-resveratrol in an amount of 500 mg per day. 3. to develop modern measures to influence the development of chf in women of this group


Eligibility criteria:
inclusion criteria: * availability of a signed informed consent (information sheet) of the patient to participate in the clinical trial; * female patients in the postmenopausal period (1-4 years) with hypertension (stage i-ii, stage i-ii), which is established according to the classification of arterial hypertension (htn) by stages, degrees and cardiovascular risk. accordingly, the indicators sbp within 140 - 159 mmhg, dbp 90 - 99 mmhg - htn stage i; sbp within 160 - 179 mmhg, dbp 100 - 109 mmhg - htn stage ii. depending on the damage to target organs: stage i - objective signs of organic damage to target organs are absent; stage ii - there are objective signs of target organ damage without symptoms or dysfunction: lv hypertrophy (according to ecg, echo-cg, mri). * reduced bone mineral density (bmd), which meets the criteria for osteopenia of the i-iii degree, established by ultrasound densitometry: osteopenia of the i degree t-score from -1.0 to -1.5, ii degree t-score from -1.5 to -2.0, iii degree t-score from -2.0 to -2.5; * patient's readiness for adequate cooperation in the process of clinical trials. exclusion criteria: * diagnosed congenital or acquired heart defects; * established non-coronary myocardial diseases (myocarditis, cardiomyopathy); * rhythm or conduction disorders with concomitant hemodynamic disorders (extrasystoles, paroxysmal tachycardias, atrial fibrillation/flutter, av block 2 and 3 degrees); * endocrine diseases, blood system diseases, systemic connective tissue diseases; * diagnosed chronic obstructive pulmonary disease; * impaired renal function (glomerular filtration rate according to the ckd-epi formula less than 60 ml/min), liver. * verified oncological diseases; * abnormal uterine bleeding, endometriosis, pelvic inflammatory diseases; * endometrial polyps and large uterine fibroids; * inflammatory bowel diseases (ibd): crohn's disease, nonspecific ulcerative colitis; * hormone therapy; * artificial early menopause; * hiv/aids; * alcohol or drug addiction; * intolerance or allergic reaction to resveratrol, microcrystalline cellulose, grapes, red wine or blueberries; * participation in other clinical trials
combination chemotherapy followed by surgery in treating patients with stage iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage iiia non-small cell lung cancer.

objectives: * evaluate the efficacy of irinotecan based chemotherapy in patients with stage iiia non-small cell lung cancer. * investigate the phenotypic changes induced in the tumor by this treatment. outline: patients receive iv cisplatin over 30 minutes followed by iv irinotecan over 30 minutes on days 1, 8, 15, and 22. treatment repeats every 6 weeks for 3 courses until disease progression. once potential candidates for resectability are determined, patients undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of completing the last course of chemotherapy. following resection, patients responding to chemotherapy receive 3 additional courses of iv carboplatin and paclitaxel over 3 hours. patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel. chemotherapy ceases if disease remains stable after 8 weeks. patients are followed every 3 months for the first year after treatment, then every 6 months thereafter for survival. projected accrual: this study will accrue 20 patients over 18 months.

Eligibility criteria:
disease characteristics: * histologically confirmed, previously untreated stage iiia (t1-2 n2 m0) non-small cell lung cancer patient characteristics: age: * over 18 performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * total bilirubin no greater than 1.5 mg/dl renal: * creatinine clearance at least 55 ml/min other: * not hiv positive * no active infections * not pregnant or lactating * effective contraception required of fertile patients during study participation * no coexisting medical condition prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy * no concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiation therapy * no concurrent radiation therapy surgery: * not specified other: * no concurrent use of investigational agents during study participation

Keywords: stage iiia non-small cell lung cancer
postoperative or salvage radiotherapy (rt) for node negative prostate cancer following radical prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of this study is to see what effects, good and/or bad, proton radiation, and/or conventional radiation and hormonal therapy (if applicable), has on prostate cancer that has already returned or the risk of prostate cancer returning.


Eligibility criteria:
inclusion criteria: * prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy. * maximum psa value of 20 ng/ml. exclusion criteria: * evidence of distant metastasis (m1). * prior systemic chemotherapy for any reason. * previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment. * active inflammatory bowel disease (crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. (non-active diverticulitis and crohn's disease not affecting the rectum are allowed). * history of hip replacement. * prior or concurrent cancer, other than non-melanomatous skin cancer, unless disease free for at least 5 years. * taking saw palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Keywords: proton radiation, prostate cancer
differential target multiplexed spinal cord stimulation

Conditions: Failed Back Surgery Syndrome; Persistent Spinal Pain Syndrome Type 2

Summary: evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.


Eligibility criteria:
inclusion criteria: * patients with severe chronic pain (\> 5 on numeric rating scale, nrs) for at least 6 months due to fbss (psps t2) and suitable for treatment with dtm scs according to the treating physician * age \> 18 years * patient has been informed of the study procedures and has given written informed consent * patient willing to comply with study protocol including attending the study visits exclusion criteria: * expected inability of the patient to receive or properly operate the spinal cord stimulation system * history of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus bechterew * active malignancy * addiction to drugs, alcohol (\>5 units per day) and/or medication * evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator * immune deficiency (e.g. hiv positive, immunosuppressive treatment) * life expectancy \< 1 year * local infection or any other skin disorder at site of incision * pregnancy * other implanted active medical device

Keywords: differential target multiplexed spinal cord stimulation
a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction and pulmonary vascular disease

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: this is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (hfpef) and pulmonary vascular disease. the primary objective is to evaluate whether macitentan 10 mg reduces n-terminal pro-brain natriuretic peptide (nt-pro-bnp) as compared to placebo in these patients.


Eligibility criteria:
inclusion criteria: * signs or symptoms of heart failure (hf) (nyha fc i i and ii i ) requiring treatment with at least one oral diuretic (any type) * left ventricular ejection fraction (lvef) ≥ 40% (by echocardiography at screening) * structural heart disease consistent with heart failure with preserved ejection fraction (hfpef) established by echocardiography at screening * elevated nt-probnp * pulmonary vascular disease or right ventricular dysfunction exclusion criteria: * any prior valid measurement of lvef \< 40%. an echocardiogram is considered valid if its quality is sufficient to allow accurate assessment of lvef and if it is reflective of the true status of the subject * cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (cabg) or percutaneous coronary intervention (pci) within 3 months of screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc) * systolic blood pressure (sbp) ≥ 180 mmhg, or diastolic blood pressure (dbp) ≥ 110 mmhg during screening * hemoglobin \< 100g/l (\< 10 g/dl) at screening * significant parenchymal lung disease (e.g., severe copd, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism) * severe renal dysfunction with an estimated glomerular filtration rate (egfr) \< 30 ml/min per 1.73 m2 * severe hepatic impairment, e.g., child pugh class c other protocol-defined inclusion/exclusion criteria may apply