Kornimate/medical-research-clean huggingface dataset:
heart & diabetes - feasibility study

Conditions: Acute Heart Failure

Summary: the main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in addition to reference finger-stick values.

heart failure is a common disease (prevalence worldwide: 22 million; incidence worldwide: 2 million; prevalence in italy: 750.000; incidence in italy: 170.000), affecting 1-2% of overall population and accounting for a significant proportion of healthcare costs. recurrent hospital admissions represent the majority of the disease-related cost. about 15-25% of patients with hf are diabetics: the presence of diabetes significantly worsens prognosis in patients with heart failure and increases the risk of death by 30% compared to subject without diabetes. the intensive control of glycemia during acute heart failure is an objective of primary importance, which can be obtained only with a proper strategy of patient management and with a considerable organizational effort. in a shared protocol aimed at a tight control of glycemia, the use of continuous glucose monitoring (cgm) is expected to allow an easier management of the patient and a more accurate implementation of the protocol. the main purpose of this study is to validate an intensive protocol of insulin infusion and subsequent subcutaneous insulin administration with the support of continuous glucose monitoring, in addition to reference finger-stick values.

Eligibility criteria:
inclusion criteria (all of the following inclusion criteria must be met for the patient to be enrolled in the study): * acute heart failure, defined according to current esc guidelines * hba1c \> 7.5% at admission in cardiology unit * glycemia \> 180 mg/dl at admission in cardiology unit * the patients signed the informed consent exclusion criteria (if any of the following criteria are met, patients cannot be enrolled in the study): * heart failure in acute infarction or cardiogenic shock * creatinemia \> 3.5 mg/dl at admission or in hemodialytic therapy * cirrhosis * acute infective pathology * cardiac revascularization during the hospitalization or in the preceding 3 months * life expectance \< 12 months * age \< 18 years * pregnant women * informed consent not signed * subject included in other protocols

Keywords: acute heart failure hyperglycemia acute heart failure with high levels of glycemia
the role of chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers

Conditions: Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Head and Neck

Summary: this study evaluates the role of narrow band imaging (nbi) endoscopy compared with lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.

patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (escc). small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. to improve detection chromoendoscopy is recommended. in this project patients are divided into two groups based on received chromoendoscopy (nbi versus lugol). the results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of escc.

Eligibility criteria:
inclusion criteria: * patients with past history ( \>= 1 year ) of head and neck cancer treated curatively and receiving regular follow - up at the outpatient clinic of the head and neck department of maria skłodowska - curie memorial cancer center, institiut of oncology * 18 years and older * diagnosis of squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx * zubrod scale 0-2 * provided written informed consent exclusion criteria: * lack of written informed consent * known allergy to iodine * clinical conditions precluding upper gi endoscopy

Keywords: endoscopy, gastrointestinal cancer screening
activity of trabectedin or gemcitabine + docetaxel in uterine leiomyosarcoma

Conditions: Leiomyosarcoma

Summary: the management of patients with uterine leiomyosarcomas poses many difficulties. despite 60% of women present with disease limited to the uterus, cure rates range from 20 to 60%. patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, except for a subset of selected patients with completely resectable disease, the median survival is less than one year. treatment options for recurrent/metastatic uterine leiomyosarcoma are limited. the most active drugs are doxorubicin ± ifosfamide and gemcitabine + docetaxel (gd) with response rate of 25-55% and 27-53%, respectively. both these regimens have been increasingly used in the last years also in the adjuvant setting. for relapsed patients other drugs have been tested as single agent but negligible activity was observed. trabectedin (yondelis® -t) is a marine-derived cytotoxic approved by emea. it is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide or who are unsuitable to receive these agents. among sts, activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma. although the response rate did not exceed 10%, t was demonstrated to provide disease control, with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20% at 6 months. so far no phase ii studies tested the activity of t in uterine leiomyosarcoma specifically. this study is aimed at evaluating the activity of t (arm a) in advanced uterine leiomyosarcomas, having gd (arm b) as an internal control in parallel translational studies will be performed to identify factors predictive of the activity of t in this specific histotype.


Eligibility criteria:
inclusion criteria: 1. histologically proven uterine leiomyosarcoma. 2. persistent or locally relapsed and/or metastatic disease. 3. at least one previous systemic treatment with an anthracycline ± ifosfamide or gemcitabine ± docetaxel. 4. measurable disease, as defined by recist criteria. 5. ecog ps \<=2. 6. age \>= 18 years. 7. a minimum of 3 weeks since prior tumor directed therapy 8. recovery from toxic effects of prior therapies to nci ctc grade 1 or lower. 9. adequate haematological function. 10. adequate renal function. 11. adequate liver function. 12. signed informed consent. exclusion criteria: 1. prior exposure to trabectedin. 2. peripheral neuropathy, grade 2 or higher. 3. history of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse. 4. known cns metastases. 5. active viral hepatitis or chronic liver disease. 6. unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias. 7. active major infection. 8. other serious concomitant illnesses

Keywords: trabectedin uterine leiomyosarcoma
assessing the efficacy of repeat, monthly treatments of cutaneous neurofibromas (cnfs)

Conditions: Neurofibromas, Cutaneous; Neurofibromatosis 1

Summary: this study will evaluate the tolerability and effectiveness of four fda-approved treatments in neurofibromatosis type 1 cutaneous neurofibromas. these treatments are: a 1064nm laser, a 755nm laser, and kybella and polidocanol injections. each patient will have a treatment and a control site. this study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. if there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. three treatment visits with the crossover treatment will then take place.


Eligibility criteria:
inclusion criteria: 1. adult ≥18 years of age 2. have a diagnosis of nf1 based on germline genetic testing or by meeting ≥ 2 the following criteria: * family history of nf1 * six or more light brown ("cafe-au-lait") spots on the skin * presence of two or more neurofibromas of any type, or one or more plexiform neurofibromas * freckling under the arms or in the groin area * two or more pigmented, benign bumps on the eye's iris (lisch nodules) * a distinctive bony lesion: dysplasia (abnormal growth) of the sphenoid bone behind the eye, or dysplasia of long bones, often in the lower leg * tumor on the optic nerve that may interfere with vision 3. patients must be seeking treatment for cnf 4. patients must have ≥ 6 paired cnf (3 to be treated and 3 untreated) that are visible and measure between 2-8mm in size. these must be in areas amenable to treatment and surveillance with digital photography 5. cnf must be located on the trunk, arms or legs of the patient 6. able and willing to comply with all visit, treatment and evaluation schedules and requirements 7. able to understand and provide written informed consent exclusion criteria: 1. individuals who cannot give informed consent or adhere to study schedule. 2. actively tanning during the course of the study. 3. known allergy to deoxycholic acid or polidocanol. 4. women who are pregnant. 5. those with acute thromboembolic diseases. 6. those with bleeding abnormalities or those who are currently being treated with antiplatelet or anticoagulant therapy. 7. any condition which, in the investigator's opinion, would make it unsafe (for the participant or study personnel) to treat the participant as part of this research study.
covid-19 recovered volunteer research participant pool registry

Conditions: Recovered From COVID-19

Summary: this is a prospective observational registry of covid-19 recovered patients who are no longer symptomatic. this registry is intended to serve as a pool of individuals that can participate in studies associated with serological testing, characterization of immunity and immune response, vaccine development, and convalescent plasma donors.


Eligibility criteria:
inclusion criteria: * all patients seen the in emergency room, admitted patients, or seen in outpatient clinics that are: * tested positive for covid-19 and recovered * suspected to have covid 19 and validated with serological testing * suspected to have covid 19 by symptoms, clinical course, and laboratory testing ruling out other respiratory viral disease
comparison of quantiferon-tb gold assay with tuberculin skin testing in patients with chronic liver disease

Conditions: Chronic Liver Disease; Liver Transplantation; Tuberculosis

Summary: the purpose of the study is to estimate the usefulness of the quantiferon®-tb gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for ltbi

tuberculosis (tb) is an important cause of morbidity and mortality in organ transplant recipients. although the tuberculin skin test (tst) is recommended for screening of latent tuberculosis infection (ltbi) in all candidates for liver transplantation, the performance of the tst in this setting is less than optimal, due to a lack of specificity and a lack of sensitivity in a population that is relatively immunocompromised. recently, a new test named quantiferon-tb gold (qft-g) has been approved for the diagnosis of ltbi. qft-g is expected to be more specific than tst. however, there are no studies defining the performance of qft-g in a population of patients on a waiting list for liver transplantation. we plan to estimate the usefulness of the qft-g test for the diagnosis of ltbi in a cohort of patients with end-stage liver disease. we hypothesize that the qft-g test will correlate better with the risk of ltbi.

Eligibility criteria:
inclusion criteria: * chronic liver disease on the waiting list or being wait listed for liver transplantation exclusion criteria: * unable to provide informed consent * previous history of immediate hypersensitivity to tst * previous severe local ulceration with tst * suspected active tb

Keywords: tuberculin skin test quantiferon-tb gold assay chronic liver disease liver transplantation latent tuberculosis infection
radiotherapy followed by adjuvant chemotherapy in nk/t-cell lymphoma

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Summary: the purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage i/ii nk/t-cell lymphoma.

for patients with stage i/ii nk/t-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. some studies demonstrated the advantage of upfront radiotherapy. therefore, we designed this single-arm phase ii study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with dice regimen plus peg-asparaginase which was proved to be effective in nk/t-cell lymphoma.

Eligibility criteria:
inclusion criteria: * age range 14-70 years old * histological confirmed, previously untreated stage i/ii nk/t cell lymphoma in the upper-aerodigestive tract * ecog performance status 0-1 * life expectancy of more than 3 months * without prior history of pancreatitis * adequate bone marrow and organ functions exclusion criteria: * low risk population (definition: stage i without local invasion, b symptoms and high ldh level) * pregnant or lactating women * with contraindication of steroid including uncontrolled diabetes * serious uncontrolled diseases and intercurrent infection * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Keywords: nk/t-cell lymphoma radiotherapy adjuvant chemotherapy
establishment of an elisa for the recognition of procalcitonin variants in patients with hyperprocalcitonemia.

Conditions: Sepsis; Pre-Eclampsia; Granulomatosis With Polyangiitis; Microscopic Polyangiitis; Adiposity; SIRS; Procalcitonin

Summary: procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. more than 20 years ago it has been shown that dipeptidylpeptidase-4 (dpp-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice. however, it is unknown if this applies also in humans. by using an elisa-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data.

procalcitonin is a protein consisting of 116 amino-acids which can rapidly rise under inflammatory conditions and sepsis. more than 20 years ago it has been shown that dipeptidylpeptidase-4 (dpp-4) cleaves procalcitonin from the n-terminus, resulting in a truncated procalcitonin-variant which consists of 114 aminoacids. within their workgroup the investigators found that the truncated procalcitonin-variant had deleterious effects on vascular integrity during sepsis in mice: they observed that binding of truncated procalcitonin to the crlr/ramp1-receptor on vascular endothelium lead to phosphorylation and destruction of ve-cadherin, an essential part of adherens junctions. consequently, paracellular leakage of proteins and fluid from blood vessels developed. it is unknown if these effects also apply to humans. by using an elisa-assay the investigators want to examine the ratio between native and truncated human procalcitonin during diseases accompanied with hyperprocalcitoninemia and correlate the results with clinical data. futhermore, they want to examine if the procalcitonin-variants have influence on cytokine levels and surface antigens on immune cells by performing multiplex immunoassays and facs-analysis.

Eligibility criteria:
inclusion criteria: * age \>18 * patients with diagnosis... * sepsis or, * sirs after cardiothoracic surgery or, * adipositas or, * granulomatosis with polyangiitis/microscopic polyangiitis or, * pre-eclampsia * healthy control subjects * written informed consent exclusion criteria: * participation in an interventional study trial within the last 3 months * relationship to study investigator
phase 1/2 study of anti gm-2 monoclonal antibody to treat multiple myeloma

Conditions: Multiple Myeloma

Summary: this study will test the ability of a specially designed monoclonal antibody to destroy multiple myeloma cells. this antibody is unique in its ability to promote the death of multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity (adcc)and complement dependent cytotoxicity (cdc). the study is designed to determine both the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.

biw-8962 is a monoclonal antibody which targets the gm-2 ganglioside which is expressed at high levels on the surface of multiple myeloma cells. this is a phase 1/2 study design. the phase 1 component will establish the active biologic dose (abd) or the maximum tolerated dose (mtd) as well as the appropriate dosing frequency based on the pharmacokinetics of the antibody and approximately 45 subjects will be enrolled in this part of the study. the initial dosing frequency will be every two weeks and the doses to be tested will range from 0.03 mg/kg to 10 mg/kg. once the recommended phase 2 dose and frequency have been established in phase 1, the efficacy of the drug will be investigated in approximately 35 subjects in phase 2. the study did not proceed beyond the phase 1a portion. on 30 nov 2010, kyowa hakko kirin pharma, inc. (kkp) notified investigators of the decision to terminate biw-8962-001 due to a lack of efficacy in multiple myeloma. the phase 1 part b and the phase 2 components of the study were not conducted. the study was terminated and summarized in an abbreviated clinical study report (submitted 26 june 2012; sn045). kyowa kirin pharma has no current plans to pursue the use of biw8962 in multiple myeloma.

Eligibility criteria:
inclusion criteria: * relapsed or refractory myeloma * m-protein in serum and/or urine by imwg criteria. * bone marrow plasma cells or plasmacytoma * related organ or tissue impairment (crab) * subjects without detectable m protein are eligible if they have an abnormal serum free light chain ratio (flc) or if they have at least 10% plasma cells in the bone marrow exclusion criteria: * ongoing infection * cardiac disease * uncontrolled hypertension * active liver disease

Keywords: multiple myeloma gm-2 ganglioside monoclonal antibody potelligent design treatment of subjects who have failed previous treatment
evaluation of iron supplementation during darbepoetin alfa treatment in prophylaxis of severe anaemia chemo-induced

Conditions: Neoplasms; Anemia

Summary: the purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by darbepoetin alfa classic treatment or by association of darbepoetin alfa -ferric saccharose systematic supplementation, administered concomitantly with chemotherapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * well-informed written consent, signed by the patient * patient picked up for solid tumor treatment, whichever the localization, with or without metastasis * patient revealing, before or during chemotherapy, a moderate anemia, that means: men: 9\<hb\<12 g/dl; women: 9\<hb\<11 g/dl. * patient for who at least four chemotherapy cycles are planed (eight in case of weekly chemotherapy) after inclusion in the study * patients with life expectancy higher than three months * patient with general conditions compatible with the study's follow-up exclusion criteria: * contra-indication for venofer * anemia which can have curative treatment * bloody transfusion during the previous four weeks * documented or suspected medullary invasion * uncontrolled arterial hypertension * acute bacterial infection * transferrin saturation's coefficient * pregnancy * ferric salts oral treatment interrupted since less than one week * patient with bad french language's comprehension * patient with a major psychiatric pathology * patient under guardianship, trusteeship or justice safeguard

Keywords: neoplasms solid anemia darbepoetin alfa ferric saccharose venofer® aranesp®
study of tamoxifen dose escalation in breast cancer patients with cyp2d6 polymorphisms

Conditions: Breast Cancer; CYP2D6 Polymorphism

Summary: tamoxifen is an important drug for the treatment of breast cancer. used adjuvantly after operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer death by one third. used preventatively it also reduces the risk of breast cancer by 50% in women at high risk for developing the disease tamoxifen needs to be activated in the body to an active form called endoxifen, mainly by the enzyme called cyp2d6. patients have variable capability to activate tamoxifen due to variable function of this enzyme. studies showed clear correlation of specific genetic variant of cyp2d6 with endoxifen blood levels. it is estimated that up to 25% caucasian population have reduced or even absent cyp2d6 function. more recently, there were studies that showed the correlation with genetic variant of cyp2d6 and breast cancer relapse in early breast cancer patients treated with tamoxifen. food and drug authority (fda) in america and recommended checking cyp2d6 genotype in patients receiving tamoxifen treatment, but they did not specify how to interpret the genotype results and what kind actions to take in patient with adverse genotype. the aim of the investigators study is to see if increasing tamoxifen in patients with genetic polymorphism of cyp2d6 will increase endoxifen level to the same range of most patients who have wild type (normal functional)cyp2d6.


Eligibility criteria:
inclusion criteria: * ecog performance status ≤ 1 * life expectancy ≥ 6 months * histologically or cytologically confirmed early, locally advanced or metastatic breast cancer * oestrogen receptor positive * about to start tamoxifen treatment or already on tamoxifen 20mg daily * adequate hepatic and renal function exclusion criteria: * concurrent chemotherapy or radiotherapy * treatment with medications that may alter cytochrome p450 (cyp450)3a4/5 and cyp2d6 activities * history of thrombosis * history of non-compliance with previous or current treatment; * medical or psychiatric conditions that compromise the patient's ability to give informed consent

Keywords: breast cancer tamoxifen endoxifen polymorphism of cyp2d6