Kornimate/medical-research-clean huggingface dataset:
hepatic arterial infusion in treating patients with locally advanced, non-metastatic cholangiocarcinoma

Conditions: Cholangiocarcinoma; Liver Neoplasms

Summary: this pilot clinical trial studies the safety and effectiveness of continuous hepatic arterial infusion (hai) of floxuridine (fudr) alone or in combination with other chemotherapeutic drugs in treating patients with locally advanced cholangiocarcinoma that cannot be removed by surgery. hai is a method to deliver higher concentrations of fudr more directly to liver tumors and reduces side effects. hai alone or in combination with oxaliplatin and/or gemcitabine may significantly improve clinical outcomes of patients with locally advanced cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease. diagnosis must be histologically or cytologically confirmed for continued treatment on study after pump placement. * patient must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (ct) scan/mri * patient must have disease that is unresectable or borderline resectable with \< 70% liver involvement by cancer * patient must be \>= 18 years old. * patient's eastern cooperative oncology group (ecog) performance status must be =\ = 60%) * patient must have normal organ and marrow function as defined below: * absolute neutrophil count \>= 1,500/mcl * platelets \>= 75,000/mcl * total bilirubin =\< 2 mg/dl * aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\])/alanine aminotransferase (alt) (serum glutamic pyruvate transaminase \[sgpt\]) =\< 5 x institutional upper limit of normal * creatinine \<= institutional upper limit normal * patient must be able to understand and willing to sign a written informed consent document exclusion criteria: * patients must not have had prior treatment with fudr * patient must not be receiving any other investigational agents * patient must not have a diagnosis of gilbert's disease * patient must not have a diagnosis of hepatic encephalopathy * patient must not have had prior external beam radiation to the liver * patient must not have a diagnosis of sclerosing cholangitis * patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * patient must not be pregnant or breastfeeding
a study to compare the effects of the infusion of a sepsis drug between healthy adults and adults with damaged livers

Conditions: Sepsis

Summary: this compound, gr270773, is a lipid based compound being developed to treat sepsis. lipids are broken down in the body by the liver. this study is designed to see whether the effect of the drug in people with poorly functioning livers is any different to the effect on healthy adults.


Eligibility criteria:
inclusion criteria: * patients with known history of liver disease (either with or without history of alcohol abuse). * previous confirmation of liver cirrhosis by liver biopsy or other medical imaging technique. * child-pugh score of 7-9 (moderate impairment) bmi 19-29 kg/m2. * healthy volunteers to match the hepatically impaired subjects in a 1:1 ratio by gender, age, bmi. exclusion criteria: * lactating or pregnant females. * subjects with bp \> 160/90. * subjects who, within the past six months, have had a history of significant drug or alcohol abuse, or any indication of regular use of more than 14 units of alcohol per week for women, or 21 units/week for men.

Keywords: hepatic impairment gr270773 emulsion
registry platform ovarian and endometrial cancer

Conditions: Ovarian Cancer; Endometrial Cancer; Ovary Neoplasm; Endometrial Neoplasms; Carcinoma, Ovarian; Carcinoma; Neoplasm, Ovarian

Summary: the purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (oc) or advanced or metastatic endometrial cancer (ec) in germany.

smaragd is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in germany. the registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. at inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. during the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. health-related quality of life (hrqol) will be evaluated for up to three years.

Eligibility criteria:
inclusion criteria: * confirmed high grade oc (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer): * patients with figo stage iib-iv oc who are starting systemic treatment or * patients with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting systemic treatment for recurrent/relapsed disease. * locally advanced and inoperable or metastatic ec (figo stage iii-iv) who are starting systemic first-line therapy. * signed and dated informed consent (ic): * patients participating in pro module: ic before first therapy cycle * patients not participating in pro module: ic no later than six weeks after start of first therapy cycle exclusion criteria: * newly diagnosed early-stage oc (figo stage i-iia) * low grade moc or * early-stage ec (figo stage i-ii)

Keywords: registry health service research epidemiology germany palliative treatment palliative care
jafron haemoadsorption during cardiopulmonary bypass

Conditions: Cytokine Release Syndrome

Summary: cardiopulmonary bypass (cpb) is often associated with degrees of complex inflammatory response mediated by various cytokines. this response can, in severe cases, lead to systemic hypotension and organ dysfunction. cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. jafron is a device designed to remove cytokine from the blood using haemoadsorption (ha). this preliminary report aims to evaluate the potential of jafron to decrease peri-operative cytokine levels in cardiac surgery.

in this context the investigators introduce the study design for multi-centre pilot randomized report in 40 patients undergoing elective cpb procedures with an expected time \>120 minutes for each extracorporeal procedure. patients will be randomly allocated to either standard of care (n = 20) or jafron ha(n = 20) during cardiopulmonary bypass (cpb). the primary outcome will be the difference between the two groups in cytokines levels (il-2, il-6,tnf-α, ifn gamma) and secondary parameters (fibrinogen, albumin, platelets, hemoglobin, hematocrit, white blood cells, neutrophils,lymphocytes, monocytes, eosinophils, basophils) will measured at anaesthesia induction, at the endof cpb , primary outcomes: hemodynamics with or without vasoconstrictors use, the mechanical ventilation (mv) (hours) time and length of stay in intensive care unit (icu) (hours). this prospectivemulti-centre randomized controlled report will take place in two centres: anthea hospital, gvmcare \& research, bari, italy; virgen de la arrixaca university hospital, murcia, spain; between may 2022 and september 2022. the target population per centre will include (n=20) patients; will beallocate for each center to either standard of care (n = 10) or jafron ha (n = 10) planned for elective cardiac surgery with increased risk of cytokine release.

Eligibility criteria:
inclusion criteria : * elective cardiac surgery under cpb * double valve replacement or a complex surgery with an expected cpb duration \> 120 min * redo cardiac surgery exclusion criteria: * end-stage renal disease (dialysis dependence) * active infectious endocarditis * emergency or off-pump procedure * prescription of non-steroidal antiinflammatory medication (except for low-dose aspirin) or corticosteroids within 7 days * enrolment in another conflicting study * administration of human albumin during cpb
corevalve™ evolut r™ forward study

Conditions: Aortic Valve Stenosis

Summary: prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the evolut r system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

the study objective is to document the clinical and device performance outcomes of the evolut r system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement. prospective, single arm, multi-center, observational, post market study. in australia and canada it is a prospective, single arm, multi-center pre-market study. up to 60 centers worldwide. geographies may include europe, australia, middle east and africa, latin america and canada. approximately 1000 implanted subjects, consented for follow-up through three years. for each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years.

Eligibility criteria:
inclusion criteria: * symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement * acceptable candidate for elective treatment with the evolut r system and in conformity with the local regulatory and medico economic context * age ≥80 years or considered to be at high or greater risk for surgical aortic valve replacement (avr) where high risk is defined as: * society of thoracic surgeons (sts) predicted risk of mortality ≥8% or * documented heart team agreement of risk for avr due to frailty or comorbidities. * geographically stable and willing to return to the implanting site for all follow-up visits * of legal age to provide informed consent (patient informed consent or data release form) in the country where they enroll in the trial * the patient has been informed of the nature of the study, is able and willing to provide consent without assistance from a legal representative and has consented to participate, and has authorized the collection and release of his/her medical information by signing a patient informed consent or data release form. exclusion criteria: * known hypersensitivity or contraindication to aspirin, heparin (hit/hitts) and bivalirudin, ticlopidine, clopidogrel, nitinol (titanium or nickel), or sensitivity to contrast media, which cannot be adequately premedicated * preexisting mechanical heart valve in aortic position * ongoing sepsis, including active endocarditis * anatomically not suitable for the evolut r system * estimated life expectancy of less than 1 year * participating in another trial that may influence the outcome of this trial * need for emergency surgery for any reason
effects of not measuring gastric residual content on feeding tolerance in premature infants infants

Conditions: Premature Infant

Summary: omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.

infants were randomized into 2 groups. group 1 had no gastric residuals evaluated prior to feeding. group 2 had gastric residuals evaluated prior to feeding. nutritional outcomes were compared between groups.

Eligibility criteria:
inclusion criteria: * gestational age less than 32 weeks, * birth weight less than or equal to 1250 grams, * initial feeding tolerated within 48 hours of life exclusion criteria: * congenital or chromosomal disorders, * severe complications leading to death in the first week of life

Keywords: very low birth weight infants premature nutrition gastric residual
evaluation of rapid diagnosis tests in imported malaria

Conditions: Malaria

Summary: the annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. delayed care and frequent drug resistance of plasmodium falciparum (pf), the most frequent form of malaria, is responsible for these deaths. each year, 5000-8000 travellers return to france with malaria, 4/5 from africa and with pf. clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. few emergency wards are specialized for tropical diseases. for most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision

the annual number of cases of clinical malaria worldwide is estimated to be 300-500 million leading to 1.5 million deaths. delayed care and frequent drug resistance of plasmodium falciparum (pf), the most frequent form of malaria, is responsible for these deaths. each year, 5000-8000 travellers return to france with malaria, 4/5 from africa and with pf. clinical features associated with a malaria crisis are poorly predictive and misdiagnosis can be easily made. diagnosis of accurate malaria rely on microscopic examination of stained thin and thick blood films by a well trained microscopist. few emergency wards are specialized for tropical diseases. for most of them, malaria is a rare disease and hours are lost before accurate microscopy can permit the decision the rapid diagnostic tests (rdt) for malaria are designed to give a sensitive response within 15 minutes. they are based on the immunodetection of histidin rich protein 2 (hrp2) or the pf lactico dehydrogenase (pfldh), specific of plasmodium falciparum or plasmodial lactico dehydrogenase (pldh), or aldolase, specific of gender of the four species of human malaria. recent increase of performances and availability prompted who to recommend their use for the diagnosis of malaria when microscopy is unavailable. in france, competence exists on the whole of the territory but expertise is usually confined to major referral centers. we intend to evaluate the performances of 4 rdt in 6 laboratories who perform the diagnosis of malaria on patients samples who returned from tourist or family or professional trips. the simultaneous detection of the plasmodial hrp2, pfldh, aldolase and pldh will be compared with the thick blood film as reference. discrepant results will be analysed by pcr. the determination of the sensitivity, the specificity, the predictive positive value and the predictive negative value of the rdt is the principal objective.

Eligibility criteria:
inclusion criteria: * no refusal by patient * sample for malaria diagnosis exclusion criteria: * patient who do not want to participated to the study

Keywords: malaria diagnosis rdt pldh hrp2 patients with fever and history of travel in a malaria country
a study of trastuzumab emtansine (trastuzumab-mcc-dm1) administered intravenously to patients with human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this was a multi-institutional, open-label, single-arm, phase ii study of trastuzumab emtansine (t-dm1) administered by intravenous (iv) infusion to patients with human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer (mbc).


Eligibility criteria:
inclusion criteria: * signed informed consent form. * human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer (mbc); tissue (slides or blocks) available for her2 confirmation. * history of progression on her2-directed therapy for the treatment of her2-positive breast cancer. * at least 1, and no more than 3, chemotherapy regimens for mbc. * granulocyte count ≥ 1500/μl, platelet count ≥ 100,000/μl, and hemoglobin ≥ 9 g/dl. * serum bilirubin ≤ 1.5 mg/dl, aspartate aminotransferase (ast), alanine aminotransferase (alt), and alkaline phosphatase ≤ 2.5x the upper limit of normal (uln). * serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. exclusion criteria: * any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment. * prior cumulative doxorubicin dose \> 360 mg/m\^2 or the equivalent. * history of significant cardiac disease, unstable angina, congestive heart failure (chf), myocardial infarction, or ventricular arrythmia requiring medication.

Keywords: trastuzumab emtansine mbc breast cancer her2-positive breast cancer her2
comparative quantification of mtx and its metabolites post glucarpidase

Conditions: Lymphoma; Acute Lymphatic Leukemia

Summary: acidification (i.e., addition of hydrochloric acid) of plasma samples from patients who have received glucarpidase post high-dose mtx treatment is regarded as a necessary preanalytic step to avoid further in vitro enzymatic cleavage of mtx. however, it is unclear whether this acidification step is essential. a comparative study, which evaluates concentrations of mtx and its metabolites in paired (acidified versus non-acidified) plasma samples, has not yet been performed. processing plasma samples without acidification would facilitate quantification of mtx, including plasma samples from patients treated at centers without adequate laboratory facilities.

stored plasma samples (paired - acidified and non-acidified) from the specimens collection ('tumorbiobank') of the charité comprehensive cancer center will be analysed by hplc/ms. a total of 136 samples from patients post voraxaze across 3 levels of mtx concentrations: 30 without additive, 10 with 0.9% nacl, 30 with hcl (stored at -80c) 9 without additive, 9 with hcl (stored at +4c and analysed after 3-5 days) 9 without additive, 9 with hcl (stored at -20c and analysed after 3-5 days) 30 with hcl (stored at +4c versus ambient temperature)

Eligibility criteria:
inclusion criteria: * treatment with glucarpidase exclusion criteria: * lacking patient consent

Keywords: preanalytical conditions
measuring the negative predictive value and specificity of serum biomarkers in gastric cancer

Conditions: Gastric Cancer

Summary: atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis. the difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. this makes it difficult for gps to know who to refer for further testing as the current cancer referral criteria are very broad. to reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (gastropanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. it is extremely rare for gastric cancer to develop without there first being gastric atrophy. a real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the uk. scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. by using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.


Eligibility criteria:
inclusion criteria: patients referred for a 2 week wait cancer pathway endoscopy for the following indications or upper abdominal mass consistent with stomach cancer or stable upper gastrointestinal bleeding or aged 55 and over with weight loss and any of the following: * upper abdominal pain * reflux * dyspepsia exclusion criteria: * referrals for therapeutic ogd (e.g. polypectomy, feeding tube insertion) * previous gastro-duodenal surgery, * any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)
reducing risk for alzheimer's disease in high-risk women through yogic meditation training

Conditions: Mild Cognitive Impairment; Alzheimer's Disease

Summary: the purpose of this pilot study will be to test whether kundalini yoga (ky) and kirtan kriya (kk) yogic meditation is superior to memory enhancement training (met) for improving cognitive functioning, health (including cardiovascular factors), and mood in women with high ad risk.

overall, the investigators anticipate recruiting 100 women (50 or older) with mci and high alzheimer's disease risk. subjects will either receive: (1) met class for 60 minutes per week; or (2) kundalini yoga and "kirtan kriya" meditation class for 60 minutes per week. assessments will be completed immediately after the interventions at 6 and 12 weeks and follow-up visits at week 24 and 48 to monitor the overall benefit of the intervention.

Eligibility criteria:
inclusion criteria: 1. amnestic mci, as defined by a clinical dementia rating scale score of .5. 2. high cardiovascular risk defined as at least one of the following: * 7.5 percentile risk or higher using ascvd risk calculator * myocardial infarction more than 6 months ago * diabetes * taking medication for blood pressure \> 140/90 blood pressure * taking medication for lyperlipidemia ldl \>160 3. sufficient english proficiency and the 8th grade or higher reading level as determined by the word reading subtest of the wide range achievement test-iv (this criterion is necessary in order to ensure ability to participate in met, which involves reading and writing and has a flesch-kinkaid school equivalency of 7th grade) 4. capacity to provide informed consent exclusion criteria: 1. history of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder 2. recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition 3. any disability preventing participation in met or kk+ky (e.g., severe visual or hearing impairment) 4. insufficient english proficiency to participate in either met or kk+ky 5. diagnosis of dementia 6. mini mental health examination score of 23 or below 7. currently taking any psychoactive medication 8. participation in a psychotherapy that involves cognitive training 9. practice of kundalini yoga or kirtan kriya within the past year 10. myocardial infarction within the past 6 months

Keywords: memory impairment meditation yoga memory training mild cognitive impairment mci geriatric fmri alzheimer's disease cardiovascular risk