Kornimate/medical-research-clean huggingface dataset:
assessment of labile plasma iron (lpi) in myelodysplastic syndromes (mds) and primary myelofibrosis

Conditions: Myelodysplastic Syndrome; Primary Myelofibrosis

Summary: recently, it has been demonstrated that iron overload is associated with the appearance of labile plasma iron (lpi). lpi is redox active and is rapidly taken up by cells, leading to a rise in the labile iron pool (lip) and catalyzing generation of reactive oxygen species (ros), which can lead to cellular damage. the lpi data are mostly derived from thalassemia iron overload research , however, there are a few data describing lpi and its correlations with the classical iron overload parameters (ferritin, tsat) in acute anemias such as mds therefore we are going to assess lpi in iron overloaded myelodysplastic syndromes (mds) (low and high risk) and primary myelofibrosis, in order to assess whether it can be used as alternative to the routinely used parameters; tsat and ferritin levels.

approximately 60-80% of patients with myelodysplastic syndromes (mds) present with symptomatic anemia and 80-90%, of these, will require red blood cell (rbc) transfusions. excess transfusional iron causes iron overload (io) which is characterized by elevated serum ferritin (\> 1000ng/ml) and transferrin saturation (tsat \> 50%) levels. assessment of io using serum ferritin and tsat levels is not accurate enough and this is due to changes in serum ferritin and tsat during any inflammatory condition. since serum ferritin is considered as a positive acute phase reactant and therefore inflammatory state can lead to an increase in serum ferritin levels and so does not reflect the exact amount of iron overload. in contrast tsat can decrease during inflammation and in addition it follows diurnal variations.the aim of our present study is to asses the levels of lpi in patients with in iron overloaded mds patients (low and high risk), and also patients with primary myelofibrosis, in order to find out any laboratory correlations between lpi, tsat and srum ferritin levels. methods: the study will contain 50 patients low+high risk mds patients and patients with primary myelofibrosis with iron overloaded. the risk stratification of these patients will be calculated according to the wpss (who adapted prognostic scoring system) after icf (informed consent form) has been signed by the patients the following laboratory tests will be taken once during the study: * ferritin (local laboratory) * transferrin saturation (local laboratory) * crp (local laboratory) * lpi (feros™ elpi from aferrix ltd., tel- aviv, israel)

Eligibility criteria:
inclusion criteria: * age \> 18 years old * mds patients (low and high risk ) exclusion criteria: * age \< 18 years old

Keywords: mds primary myelofibrosis low+high risk mds patients patients
to compare the efficacy of n -acetylcysteine and standard therapy versus standard therapy in the prevention of ischemic hepatitis and survival post upper gi bleed

Conditions: Ischemic Hepatitis

Summary: patient presenting with upper gi bleed in ilbs (institute of liver and biliary sciences) emergency admitted to icu (intensive care unit) or shifted from ward to icu (intensive care unit) in view of upper gi bleed randomized to two groups group a : 110 patients will receive standard care + nac infusion for 72 hours group b : 110 patients will receive standard care only nac will be given at following rate : initial loading of 150 mg/kg/hr over 1 hour followed by 12.5mg/kg/hr for 4 hrs then continuous infusion of 6.25 mg/kg for the remaining 67 hrs


Eligibility criteria:
inclusion criteria: * age \> 18 and \< 75 * cirrhotics with ugie (upper gastrointestinal endoscopy ) within last 24 hours. exclusion criteria: * non cirrhotic * hepatocellular carcinoma * advanced cardiopulmonary disease * pregnancy * extrahepatic malignancy * patient on anticoagulation therapy
yoga study in breast cancer patients

Conditions: Breast Cancer

Summary: this purpose of this study is to test whether a 6-month yoga program improves quality of life and reduces fatigue and weight gain in breast cancer survivors.

women who are overweight or obese have a higher risk of breast cancer than normal weight women. furthermore, women who are overweight or obese or gain weight after diagnosis have an increased risk of recurrence or dying from breast cancer compared with normal weight women. yoga has been associated with reduced weight gain and weight loss in persons without cancer. however, no studies have tested whether yoga leads to less weight gain or weight loss in breast cancer patients. both obesity and the sequelae of breast cancer therapy can result in reduced health-related quality of life and severe fatigue, which may also be favorably affected by yoga practice. the specific aims of the proposed trial are to examine, in women with stage 0-iiia breast cancer who are at least 3 months post primary treatment for their disease (other than tamoxifen or aromatase inhibitors), the effects of a 6-month yoga intervention on health-related quality of life, fatigue, and body weight.

Eligibility criteria:
inclusion criteria: * female * age 21-75 * diagnosed with a primary breast cancer stage 0-iiia * current tamoxifen or aromatase inhibitor use is allowed * at least 3 months post treatment (e.g., surgery, chemotherapy, or radiation therapy) * bmi: 24 kg/m2 or greater (if asian or asian-american bmi: 23 kg/m2 or greater) * no contraindications to participating in a yoga program * able to come for clinic visits, and attend weekly classes, and fill out questionnaires and logs in english * gives informed consent, agrees to be randomly assigned exclusion criteria: * plans to leave the study area within the follow-up period * is pregnant or plans to become pregnant during the study period. * history of myocardial infarction (heart attack) or stroke in the previous 6 months, or diabetes (current diagnosis) * has practiced yoga more than 1 time per month in the past six months. * current use of medications likely to interfere with adherence to interventions or study outcomes * alcohol or drug abuse, significant mental illness (as assessed by study staff impression)

Keywords: breast cancer yoga quality of life obesity fatigue weight
expanded access study of tas-120 in patients with advanced cholangiocarcinoma harboring fgfr2 gene rearrangements

Conditions: Advanced Cholangiocarcinoma

Summary: the objective of the study is to provide access to tas-120 to patients with advanced cholangiocarcinoma harboring fgfr2 gene rearrangements.

this is an open-label study to provide expanded access to tas-120 prior to its commercial availability for patients with advanced cholangiocarcinoma harboring fgfr2 gene rearrangements who have failed standard therapy or who are unable to tolerate standard therapy.

Eligibility criteria:
inclusion criteria: 1. provide written informed consent. 2. \>18 years of age. 3. histologically confirmed, locally advanced, or metastatic, or recurrent unresectable cca harboring fgfr2 gene rearrangements based on testing performed by a qualified (clia-certified) laboratory. 4. patient has failed standard therapy or standard therapy is not tolerated. 5. has measurable or non-measurable lesion(s). 6. eastern cooperative oncology group (ecog) performance status 0 or 1. 7. adequate organ function. exclusion criteria: 1. history and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis. 2. history and/or current evidence of clinically significant ectopic mineralization/calcification. 3. history and/or current evidence of clinically significant retinal disorder confirmed by retinal examination. 4. a serious illness or medical condition(s) 5. pregnant or breast-feeding female

Keywords: cholangiocarcinoma cca fgfr2 gene rearrangements tas-120 futibatinib
rpcrc validation study

Conditions: Multivariate Risk Assessment for ISUP ≥2 Prostate Cancer

Summary: prostate multiparametric mri (mpmri) can detect isup ≥2 prostate cancer with high sensitivity. adding biopsies targeting suspicious lesions seen on mpmri to the classical 'systematic biopsies' (that sample the gland in a blinded way) improves the detection of isup ≥2 cancers. as a result, it is now recommended to perform a prostate mpmri before biopsy and to combine targeted and systematic biopsy. however, mpmri suffers from a lack of specificity. in a recent meta-analysis, the pooled sensitivity and specificity of prostate mpmri for detecting isup ≥2 cancers were 0.91 (95% confidence interval, 0.83-0.95) and 0.37 (95% confidence interval, 0.29-0.46) respectively. thus, accurate triage of patients suitable for biopsy might not be possible using mpmri findings alone. the rotterdam prostate cancer risk calculator (rpcrc) combines mpmri results (prostate imaging-reporting and database system score) and basic clinical and biochemical data to predict the results of prostate biopsy. if validated, this tool could help selecting patients for prostate biopsy. in this study, the investigators propose to retrospectively use the data of the prospective multicentric mri-first trial (nct0285379) to perform an external validation of the rpcrc. in addition, the pcarisk study has two secondary objectives: * to confirm that prostate specific antigen density (i.e. psa level divided by prostate volume) can stratify the risk of isup ≥2 cancer in patients with negative (pi-rads 1-2) or inconclusive (pi-rads 3) mpmri, as suggested by recent literature * to perform a preliminary evaluation of a lobe-specific risk calculator developed by our group and combining mpmri results and clinical and biochemical data to predict the risk of isup ≥2 cancer at the lobe level.


Eligibility criteria:
inclusion criteria: * patient referred for mpmri and prostate biopsy due to increased psa level, abnormal dre or family history of prostate cancer. * age ≤75 years * psa level ≤20 ng/ml * clinical stage ≤t2c exclusion criteria: * contraindication for prostate mpmri or biopsy * history of hip prosthesis, androgen deprivation therapy, pelvic radiotherapy or prostate cancer diagnosed after trans-urethral resection of the prostate.
improving quality based on the joint registry

Conditions: Registries; Quality Improvement; Hip Arthropathy; Knee Arthropathy; Hospital Performance

Summary: test whether an intervention, consisting of frequently feedback of performance outcomes and education will improve patient care, expressed in better functional outcomes, fewer complications and more quality improving interventions.

a randomized controlled trial will be conducted where hospitals will be randomized to an early versus late group, stratified by teaching status as this might influence the time available for quality improvement. randomization will be done using a computer generated randomization table in a 1:1 ratio. during the study only orthopedic surgeons performing tha and tka will receive monthly feedback by email. the intervention will consist of the following components: * monthly feedback of performance outcomes; * education on how to use joint registry data for quality improvement; * create awareness by sending monthly feedback about performance; education and by asking what improvement activities have been introduced; * hospitals will be linked to hospital with opposite performance outcomes to exchange information and find areas for improvement. during the trial, the investigators will conduct monthly measurement on intermediate outcomes showing whether the intervention reaches the target group (process evaluation). the following measurements will take place: * knowledge among orthopaedic surgeons on their recent performance and how that relates to others; * number of quality improvement activities undertaken with the aim to improve the quality of care; * planned improvement activities (e.g. record review to figure out why performance is not as good as in other centers) together with who is responsible and by which time; * number of people attending the meetings, number of times a specific account has accessed the lroi site to ensure that information has reached the target group; * survey among orthopaedic surgeons at the end of the intervention period on knowledge learned and the extent to which they think this is sustainable in daily practice. in addition, the investigators will compare the outcomes between the early and the late group to test the effectiveness of the intervention, using the appropriate regression techniques. in the second period the investigators will test the sustainability of this approach in daily practice by comparing the outcomes within the early group with the first period, and compare with the late group to test whether outcomes in the sustainability phase are similar as when actively supported.

Eligibility criteria:
inclusion criteria: * all dutch orthopedic clinics where hip- and knee replacement surgery is performed who agree to participate will be randomized. exclusion criteria: * none

Keywords: total hip/knee arthroplasty;dutch arthroplasty register; quality improvement.
effect of hormones on frequency of headache and brain structure and function in puberty

Conditions: Headache; Gender Identity

Summary: with a rising population of transgender adults and youth, there is a need for more research to meet the needs of this community. transfemale (mtf) youth (male sex, female gender identity) who begin clinical gender affirming hormone therapy (gaht) with estrogen may be at a higher risk for headache since estrogen has been linked to headache in cisgender females (female sex, female gender identity). this research hopes to learn more about headache in mtf youth.

mtf youth who will begin estrogen clinically will be enrolled in the study and will be seen twice, once before starting estrogen and then one year after beginning estrogen. cisgender males (male sex, male gender identity) will also be enrolled as a control group and will be seen once at the beginning of the study and then once a year later. the researchers will track how often youth have headaches during this time to see if it is different between groups. in a subset of the youth enrolled, an mri will be completed to also look at brain structure and function.

Eligibility criteria:
inclusion criteria: for mtf youth (cases): * identify as mtf * age 11-20 years at the time of enrollment * plan to start estrogen clinically in \&lt; 6 months for cisgender male youth (controls): * identify as cisgender male * age 9-20 years at the time of enrollment * no diagnosis of klinefelter syndrome (xxy) exclusion criteria: * cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety * known history of stroke, multiple sclerosis, or other serious neurologic condition * mri-specific exclusion criteria (weight \&gt; 500 lbs, claustrophobia, metal in body)
the hypotension prediction index in free flap transplant in head and neck surgery.

Conditions: Hypotension; Head and Neck Cancer; Perioperative Complication; Postoperative Complications

Summary: the aim of the current study is to evaluate the effects of the hypotension prediction index (hpi) on the degree of intraoperative hypotension in patients undergoing free flap surgery. the hypothesis is that implementation of the hpi algorithm will reduce the time-weighted average (twa) intraoperative hypotension below a threshold of 65 mmhg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.


Eligibility criteria:
inclusion criteria: * patients qualified to head and neck free flap surgery * written informed consent exclusion criteria: * patients under 18 years * lack of health insurance * pregnancy * known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction \< 35 % * persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (apco) monitoring

Keywords: hypotension hypotension prediction index free flap transplant head and neck cancer perioperative complications
identification of underlying conditions in men prescribed a pde5 inhibitor

Conditions: Erectile Dysfunction; Cardiovascular Diseases; Male Urogenital Diseases

Summary: erectile dysfunction (ed) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years. are men prescribed a pde5 inhibitor for ed more likely to have a new diagnosis of underlying medical conditions compared to men of a similar age not receiving pde5 inhibitor treatment?


Eligibility criteria:
inclusion criteria: * records of men aged \>18 years with an index pde5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between january 1st, 1999, and june 30th, 2008 * no prior pde5 inhibitor prescription before the index prescription * continuous enrolment with medical history for ≥60 months prior to the index prescription date exclusion criteria: * records of female subjects and any male subjects not meeting the inclusion criteria will be excluded * a subject can only be selected once independent of the assignment to the target or the control populations.

Keywords: erectile dysfunction phosphodiesterase inhibitor cardiovascular diseases
dose intralipid infusion reduces pregnancy complications caused by antiphospholipid antibody syndrome?

Conditions: Antiphospholipid Syndrome in Pregnancy

Summary: this study will address the value of adding intralipid infusion in reducing pregnancy complications related to antiphospholipid syndrome

this study will be conducted in the department of obstetrics and gynecology, tanta university on patients attending the antenatal care clinic and also on patients attending the researchers private clinics for antenatal care. the number of patients enrolled in the study will be 105 patients after application of inclusion and exclusion criteria. all women wil be thoroughly informed about the study aims and through discussion about the procedure, associated benefits and risks and will sign a written consent.

Eligibility criteria:
inclusion criteria: * pregnant women at booking date who were already diagnosed to have antiphospholipid syndrome (aps) . exclusion criteria: * patients with gestational age ≥ 9 weeks * patients with diagnosed other auto-immune disorder * patients with chronic hypertension, diabetes mellitus, thyroid disorders, * patient with renal diseases * patients who requested to withdraw from the study at any point .
ruxolitinib for the treatment of acute respiratory distress syndrome in patients with covid-19 infection

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2

Summary: it is an observational, cohort, retrospective, monocentric, non-profit study. the primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with sars-cov-2 covid-19 with rapid deterioration of respiratory parameters in the last 12 hours.

it is an observational, cohort, retrospective, monocentric, non-profit study. patients with sars-cov-2 covid-19 pneumonia who started off-label ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the covid-19 wards of the usl toscana nord ovest company. primary objective - evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with sars-cov-2 covid-19 with rapid deterioration of respiratory parameters in the last 12 hours. secondary objectives * improvement of respiratory performance. * improvement of acute phase inflammation indices. * evaluation of known adverse events related to the use of the drug. * evaluation of the epidemiological parameters in covid-19 patients. * monitoring of plasma levels of cytokines before and after treatment. exploratory objectives * analysis of the outcomes for the launch of a study on the efficacy and safety of ruxolitinib in the treatment of adrs in covid-19 patients.

Eligibility criteria:
inclusion criteria: * positive analysis for rt pcr (shanghai biotec or sansure biotech) for sars-cov-2 in a respiratory tract sample; * imaging (ct / eco / rx) positive for pneumonia; * oxygen saturation (sao2) of 93% or less in the environment; * partial oxygen pressure ratio (pao2) on inspired oxygen fraction (fio2) (pao2 / fio2) lower than 250 mg / hg, but not lower than 100 mg / hg; * rapid clinical evolution with worsening of respiratory parameters in the last 12 hours. * release of informed consent. exclusion criteria: * pregnancy and breastfeeding; * patients already in assisted breathing with tracheal cannula; * patients with active and uncompensated serious pathologies previously to the covid 19 infection; * known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the spc; * patients with renal insufficiency; * patients with positive quantiferon; * patients with documented uncontrolled bacterial sepsis (excluding procalcitonin increase in the presence of negative blood cultures); * patients with neutropenia equal to or less than 1000 pmn / mmc; * patients with thrombocytopenia equal to or less than 100000 / mmc. * hcv and / or hbv positive patients, hiv.

Keywords: ruxolitinib acute respiratory distress syndrome covid-19
investigation into the effects of blood glucose levels upon eating behavior in lean and obese non-diabetic and diabetic subjects

Conditions: Diabetes

Summary: to investigate whether the daily glucose profiles as assessed by continuous glucose monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food intake.

to evaluate the effect of blood glucose levels on eating behavior in a population of patients with diabetes in a free-living environment; the investigators plan to study lean healthy control subjects (bmi \ 30 kg/m2). the participants who qualify will be invited to use the cgms (dexcom g4 platinum) for up to 7 days. on the visit for placement of the cgms: 1) the participants will be explained by one of the study physicians how to use a glucometer (freestyle or accu-check), 2) they will have the cgms inserted under the skin, and 3) they will be instructed how to fill up the food log (informational brochures are available at the end of the protocol. on the second visit (up to 7 days after the initial visit) the cgms will be removed from the skin and the glucose meter and food log will be returned to the investigators. when this study was initially designed, it incorporated 2 additional arms in the study: t1dm and obese t2dm patients. these patients were never recruited for the study.

Eligibility criteria:
inclusion criteria: * a1c \< 10.5 % exclusion criteria: * bmi \<18 (no upper limit), * creatinine \> 1.5 mg/dl, * hgb \< 10 mg/dl, * alt \> 2.5 x uln, * untreated thyroid disease, * uncontrolled hypertension, * known neurological disorders, * untreated psychiatric disorders, * use of antidepressants and psychiatric medications, * use of weight loss medications in the 6 months prior to the study, * malignancy, * smoking, * current or recent steroid use in last 3 months, * history of current illicit drug use; * for women: pregnancy, or breastfeeding.

Keywords: glucose monitoring hunger levels food intake