Kornimate/medical-research-clean huggingface dataset:
reduction of contrast via dyevert used in cto procedures

Conditions: Chronic Total Occlusion of Coronary Artery

Summary: the is an observational, prospective study to evaluate the effect of the dyevert system on contrast volume administration in patients undergoing clinically-indicated chronic total occlusion (cto) percutaneous coronary intervention (pci)

the dyevert system is a disposable, fda-approved device that interfaces with standard manifold systems to reduce the amount of contrast used in catheterization procedures, while maintaining fluoroscopic image opacity. no study has assessed use of the system in cto pci. it would be expected that savings in cto procedures may be less than non-cto procedures due to catheter sizing and number of open guide injections required. open guide injections through larger catheters do not provide for the as much resistance, therefore decreasing the need for contrast to be diverted

Eligibility criteria:
inclusion criteria: 1. subjects undergoing cto pci at each of the participating centers. 2. contrast volume recorded during cto pci 3. subjects included in the "multicenter registry of chronic total occlusion interventions" study (allina irb approval # 948134-1) exclusion criteria: none

Keywords: chronic total occlusion coronary artery disease percutaneous coronary intervention cto pci
treatment efficiency of acupuncture in non chronified pain patients with tmds

Conditions: Temporomandibular Disorders

Summary: aim of this randomized clinical trial is to examine the treatment effectiveness of an acupuncture protocol in adult patients with non chronified tmds.

therefore there are two treatment arms, acupuncture verum and acupuncture placebo. investigators will evaluate for 4 weeks primary current pain, secondary the unassisted jaw opening.

Eligibility criteria:
inclusion criteria: * non chronified tmd pain * written informed consent exclusion criteria: * dysfunctional tmd pain * systematic diseases affecting the joints or pain perception * pregnancy * needle phobia
sarcolowdose : ultra-low dose ct scan and mri in thoracic sarcoidosis

Conditions: Sarcoidosis, Pulmonary

Summary: the goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose ct and mri with ute pulse sequences, and on the other hand, standard ct scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.

sarcoidosis is a chronic disease involving lung and mediastinum in more than 90% of cases. five to 25% of thoracic sarcoidosis are complicated by a severe fibrotic lung disease. computed tomography (ct) is critical for the diagnosis of thoracic sarcoidosis as well as for therapeutic management. repeated ct examinations, sometimes all life long, raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. based upon tube voltage and current reduction as well as iterative recontsruction, ultra-low dose ct (uld ct) allows to lower the dose up to that of a traditional chest x-ray. magnetic resonance imaging (mri) using ultrashort echo time (ute) enables lung parenchyma imaging with high signal-to-noise and spatial resolution.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or more * diagnosed with thoracic sarcoidosis according to ats/ers/wasog 1999 criteria, with stages 2, 3 or 4, or lung function significantly impaired * for whom a chest ct examination without contrast medium is indicated in the normal follow-up of the disease * covered by social security * having received information about the study and having given written informed consent exclusion criteria: * pregnant woman * adult person unable to give consent * patient in exclusion period du to another protocol

Keywords: thoracic sarcoidosis ultra-low dose computed tomography magnetic resonance imaging using ultrashort echo time
intraoperative goal-directed fluid management

Conditions: Obesity; Abdominal Surgery; Hysterectomy; Genital Prolapse

Summary: the investigators propose to determine esophageal doppler goal-directed fluid requirements in lean, overweight, obese, and morbidly obese patients with the goal of developing a body mass index (bmi)-specific fluid replacement strategy. specifically, th investigators will test the hypothesis that perioperative fluid requirements on a per-kg basis varies as a function of bmi. individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be eligible to participate

recent evidence suggests that goal-directed fluid management using stroke volume (blood ejected by the heart) is the most physiologic approach for fluid replacement. we propose to develop a body mass index (bmi)-specific fluid replacement formula based on stroke volume guidance. arterial pulse pressure variation (dpp) induced by mechanical ventilation is a proposed predictor of fluid responsiveness as well. we will therefore also investigate if stroke volume (measured by esophageal doppler monitoring) and pulse pressure variation comparably predict fluid responsiveness by simultaneously measuring both parameters. adequate tissue oxygenation is essential to maintain normal physiologic functions. fat tissue oxygenation is critically low in the obese surgical patient. it is likely that poor fat tissue oxygenation results in part from inadequate fluid replacement. we propose to determine if fat tissue oxygenation is comparable from lean to morbidly obese patients when fluid replacement is optimized. individuals scheduled for elective, open abdominal surgeries, vaginal hysterectomies or genital prolapse repair will be assigned to six groups according to bmi, from lean to morbidly obese categories. the primary aim will be to develop a statistical equation for predicting fluid requirements as a function of bmi. a maximum of 100 patients will be able to detect an r-squared of 10% or more with 90% power at the 0.05 significance level, and will enable adequate estimation of the relationship of interest.

Eligibility criteria:
inclusion criteria: 1. women, aged \> 18 years old 2. scheduled for elective, open abdominal or vaginal hysterectomies. patients will be recruited in the following body mass index categories: 1. 18.5-24.9 bmi \[kg/m2\] 2. 25.0-29.9 bmi \[kg/m2\] 3. 30.0-34.9 bmi \[kg/m2\] 4. 35.0-39.9 bmi \[kg/m2\] 5. 40.0-44.9 bmi \[kg/m2\] 6. \> 45 bmi \[kg/m2\] exclusion criteria: 1. hysterectomies due to gynecologic cancer diagnosis 2. signs and/or symptoms of decompensate heart failure 3. end-stage renal disease 4. history of susceptibility to malignant hyperthermia or porphyria 5. esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration)

Keywords: fluid management surgery obesity
daily checklists and outcome in the intensive care unit

Conditions: Critical Illness

Summary: medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the united states every year. one field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. one of the most commonly used interventions used to help reduce errors in the intensive care unit (icu) has been the implementation of checklists. the investigators propose a clinical trial in a university critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. the investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. the investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.


Eligibility criteria:
inclusion criteria: * admission to a medical intensive care unit (micu) team during the study timeframe exclusion criteria: * transfer from micu team to a separate icu team within 12 hours of admission * transfer to micu team from a separate icu team after more than 72 hours on the separate icu team

Keywords: quality improvement checklist critical care anti-bacterial agents mechanical ventilation
dasatinib (bms-354835) versus imatinib mesylate in subjects with chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia; Philadelphia-Positive Myeloid Leukemia

Summary: the primary purpose of this study is to estimate the major cytogenetic response rates of bms-354825 and imatinib (800 mg/d) in subjects with chronic phase, philadelphia chromosome positive, chronic myeloid leukemia (ph+ cml) with disease resistant to imatinib at a dose of 400-600 mg/d.


Eligibility criteria:
inclusion criteria: * men and women, 18 years of age or older. * subjects with chronic phase ph+ cml. * subjects have not been treated with imatinib at a dose \>600 mg/day. * subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day. * able to tolerate imatinib at the highest dose the subject had received in the past. * demonstrate adequate renal and hepatic function. * women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception. exclusion criteria: * women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study. * women using a prohibited contraceptive method. * women who are pregnant or breastfeeding. * men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above. * prior treatment with imatinib at a dose \>600 mg/day. * subjects who have previously identified specific bcr-abl mutations. * previous diagnosis of accelerated phase or blast crisis cml. * intolerance to imatinib at any dose. * subjects who are eligible and willing to undergo transplantation during the screening period. * serious uncontrolled medical disorder or active infection. * uncontrolled or significant cardiovascular disease. * uncontrolled hypertension. * dementia or altered mental status. * evidence of organ dysfunction. * use of imatinib within 7 days. * use of interferon or cytarabine within 14 days. * use of a targeted small molecule anticancer agent within 14 days. * subjects taking certain medications that are accepted to have a risk of causing torsades de pointes. * subjects taking medications that irreversibly inhibit platelet function or anticoagulants. * prior therapy with bms-354825.

Keywords: chronic phase philadelphia chromosome positive (ph+) chronic myeloid leukemia
comparing pre-anesthesia evaluation via telemedicine versus in person for surgical patients at moffitt cancer center

Conditions: Gynecologic Cancer; Prostate Cancer; Patient Satisfaction

Summary: this is a randomized controlled trial of patients scheduled for hysterectomy or prostatectomy surgeries who undergo a pre-anesthesia evaluation at moffitt cancer center preanesthesia testing (pat) clinic. traditionally, patients who met certain criteria based on type of surgery or comorbidities would undergo an in-person evaluation in our clinic. in order to make our patient's care more convenient and accessible, investigators have introduced telemedicine evaluation for a certain subset of patients meeting specific criteria. investigators aim with this randomized trial to investigate the hypothesis that telemedicine pre-anesthesia evaluation is non-inferior to in-person evaluation from the standpoint of day of surgery cancellation rate.


Eligibility criteria:
inclusion criteria: * able to speak and read english * able to provide signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * presurgical patients at moffitt cancer center scheduled to undergo any type of hysterectomy/salpingo-oophorectomy or prostatectomy surgeries. * possesses appropriate equipment (i.e., computer, tablet, smartphone) to undergo telemedicine evaluation. exclusion criteria: * patients with documented or observable significant cognitive barriers, hearing, or speech impairment. examples include a patient who is not alert or oriented, who is unable to sign his or her own surgical consent due to cognitive issues or who cannot understand and repeat back to study coordinator reason for study. if these barriers will not be an issue for a video phone call and can be reasonably accommodated, we will do so. however, our telemedicine technology is still very basic, and these patients may be more comfortable communicating with providers and expressing their needs during an in-person visit * surgery 3 days or less away from clinic visit. as in-person assessment is the gold standard, we need to allow some time in case a patient cannot work the technology for a telemedicine visit or an issue comes up where visit needs to be converted to in-person. * out of state patients as there are currently medical licensing concerns with conducting telemedicine on patients physically located out of state during the visit. * determined to be ineligible for surgery during evaluation
preoperative excercise training for patients undergoing coronary artery bypass graft surgery

Conditions: Coronary Artery Disease; Physical Activity; Coronary Artery Bypass Graft Surgery

Summary: patients (pts) with stable coronary artery disease (cad) requiring coronary artery bypass graft surgery (cabg) may be physically inactive during the waiting period to avoid further risks. aim of this study is to investigate the feasibility and safety of a preoperative aerobic exercise training in these pts during the waiting period and to analyze its effects on pre-, peri and postoperative outcomes

pts with stable coronary artery disease (cad) and indication for elective cabg will be prospectively randomized into a preoperative training group (tg) or a non active control group (cg). pts in tg have to perform six sessions of aerobic endurance training within two weeks prior to cabg. the following investigations will be performed at baseline, one day before surgery and at the beginning and at the end of cardiac rehabilitation: a maximal symptom limited ergospirometry, assessment of endothelial function (analysing the reactive hyperaemic index (rhi) via a finger-tonometry), assessment of quality of life (qol) using the macnew heart disease questionnaire, laboratory testing of ischemic and inflammatory parameters. baseline, peri- and postoperative characteristics will be collected.

Eligibility criteria:
inclusion criteria: * stable angina * indication for elective cabg surgery * functional capacity \> 50 watts * willingness to participate in the study exclusion criteria: * unstable angina * comorbidities precluding performance of aerobic exercise training (e.g. neurological disorders, orthopedic disorders etc) * functional status nyha iv * relevant ventricular arrhythmias * hemodynamic significant heart valve disease * myocarditis * cardiomyopathies * left main coronary artery disease \> 50% * peripheral obstructive disease (fontaine \> iib) * reduced life expectancy \< 12 months * cabg surgery during the last six months * participation in another trial

Keywords: coronary artery bypass graft surgery physical activity coronary artery disease physical training
safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices (safe-pad study)

Conditions: Peripheral Arterial Disease; Paclitaxel Adverse Reaction; Safety Issues

Summary: the safe-pad study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease. this multi-year analysis aims to create an ongoing mechanism to evaluate the safety of paclitaxel-coated devices in real world practice. the null hypothesis is that the paclitaxel-coated devices are associated with an increase in mortality relative to the non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and the alternative hypothesis is that paclitaxel-coated devices are not associated with an increase in mortality relative to the non-drug-coated devices beyond the non-inferiority margin.

this is an observational retrospective cohort study using claims data to evaluate the long-term safety of paclitaxel-coated devices compared with non-drug coated devices for femoropopliteal artery revascularization, with median follow-up time for the population surpassing 5 years. a series of supplemental sensitivity analyses will be conducted to assess and mitigate the potential for unmeasured confounding and to determine the impact of repeat interventions and paclitaxel exposure on survival. finally, sub-group analyses will be performed to investigate whether there is differential safety of paclitaxel-coated devices across different patient profiles.

Eligibility criteria:
inclusion criteria: * all fee-for-service medicare beneficiaries who underwent femoropopliteal artery revascularization. patients are allowed to undergo simultaneous revascularization of lesions outside this target vessel during the same procedure. * all patients with ≥1 year of medicare claims data prior to their index procedure. exclusion criteria: * patients without 1 year of medicare claims data prior to their index revascularization procedure. * patients that do not have both a carrier file charge and an institutional file charge on the date of an outpatient procedure. this removes procedures performed in certain clinical settings, such as office-based clinics, that do not submit the healthcare common procedure coding system (hcpcs) code needed to identify drug-coated devices.
study of cetuximab in nasopharyngeal carcinoma (npc) with chemoradiotherapy

Conditions: Nasopharyngeal Carcinoma

Summary: this is an open, multicenter phase ⅱ clinical trial on cetuximab (c225) combined with imrt + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * informed consent form signed prior to study entry * age between 18-69 years old * pathology approved to be nasopharyngeal carcinoma (types who ⅱ-ⅲ) * stage ⅲ, ⅳa, ⅳb according to uicc (international union against cancer) 2002 6th edition criteria * primary tumor measurable * kps score ≥80 * expected life span ≥6 months * adequate bone marrow function: white blood cell≥4×109/l，hemoglobin≥100g/l，platelet≥100×109/l * adequate liver function: alat/asat\<1.5 × upper limit of normal (uln), bilirubin \<1.5×uln * adequate renal function: creatinine clearance \< 1.5×uln exclusion criteria: * evidence of distant metastatic disease * surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) * previous radiotherapy for the primary tumor or lymph nodes * previous exposure to epidermal growth factor-targeted therapy * prior chemotherapy or immunotherapy for the primary tumor * other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix * any investigational agent prior to the 1st study medication * participation in another clinical study within the 30 days prior to inclusion in this study. * peripheral neuropathy \> grade 1 * known grade 3 or 4 allergic reaction to any of the study treatment * history of severe pulmonary or cardiac disease * creatinine clearance \< 30ml/min * know drug abuse / alcohol abuse * legal incapacity or limited legal capacity * active systemic infection * medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study * concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol * pregnancy (confirmed by serum or urine β-hcg) or lactation period * severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure

Keywords: radiotherapy chemotherapy drug targeting loco-regionally advanced nasopharyngeal carcinoma safety. efficacy
3d translabial ultrasound for pessary size estimation

Conditions: Pelvic Organ Prolapse

Summary: this is a feasibility study looking at the use of 3d ultrasound with vaginal manometry at various distension volumes to predict the best available pessary for successful fit.

patients who are currently using a pessary for management of pelvic organ prolapse and who are able to remove/replace the pessary themselves will be approached for recruitment. the pessary will be removed two days prior to 3d translabial ultrasound. the vagina will be distended with a pressurized compliant bag with concurrent pressure and volume measurements. translabial ultrasound will be used to measure structural parameters within the vagina at varying pressures/volumes. the volume, pressure and structural parameters measured will be compared to dimensions of the patient's own pessary to develop mathematical models to predict the best available pessary choice for the patient.

Eligibility criteria:
inclusion criteria: * are current pessary users (\> 6 months) who have no pessary related complication, including discomfort, vaginal bleeding, and pessary extrusion * are able to provide informed consent * can perform self-care, i.e. removing and inserting the pessary themselves * are willing to remove their pessary two days before the ultrasound examination date exclusion criteria: * inability to give informed consent * inability to communicate with the person performing the consent and the sonographer performing ultrasound scanning * history of pelvic radiation or surgery (excluding hysterectomy) * using pessaries other than ring, incontinence dish, donut, shaatz * inability to perform the valsalva maneuver or pelvic floor contraction * restricted mobility that prevents them from ambulating to assess the comfort level of the pessary during the initial pessary fitting visit * lack of sensation at the pelvic floor * being pregnant at the time of the examination