Kornimate/medical-research-clean huggingface dataset:
oncolytic virus plus pd-1 inhibitor to patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the efficacy of oncolytic virus plus pd-1 inhibitor to patients with advanced pancreatic cancer.

pancreatic adenocarcinoma (pdac) is a highly lethal malignancy with a 5-year survival less than 10%. approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. chemotherapy is one of the major treatments for advanced pancreatic cancer. in 2011, the prodige trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (folfirinox) was associated with a survival advantage but had increased toxicity. recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific t cells by cross-presentation of tumor antigens. pd-1 blocking antibody interferes with pd-1 mediated t-cell regulatory signaling. combination of pd-1 blocking antibody plus oncolytic virus may increase anti-tumor efficacy in pancreatic cancer. the purpose of this study is to evaluate the efficacy of oncolytic virus plus pd-1 inhibitor to patients with advanced pancreatic cancer who are refractory to standard chemotherapy. progression-free survival (pfs), objective response rate (orr), overall survival (os) and disease control rate (dcr) are measured every three weeks.

Eligibility criteria:
inclusion criteria: * ability to understand and the willingness to sign a written informed consent document. * age ≥ 18 years and ≤ 80 years. * eastern cooperative oncology group (ecog) performance status 0-2. * histologically or cytologically confirmed advanced pancreas adenocarcinoma. * patients who have received at least two lines of anti-tumor chemotherapy, or patients who have been unsuitable or unwilling to standard therapy. * locally advanced, or metastatic pancreatic cancer. * presence of at least of one measurable lesion in agreement to recist criteria. * the expected survival ≥ 3 months. * adequate organ performance based on laboratory blood tests. * patients who are willing or able to comply with study procedures. exclusion criteria: * pregnant or nursing women. * primary pancreatic cancer, or prior treatment with oncolytic virus and pd-1 inhibitor. * the diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. * inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. * severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results. * allergic to study drugs. * other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
contributions from the analysis of graphs for identification of neural cliques

Conditions: Epilepsy

Summary: the aim of the study is to demonstrate that our semantic knowledge (elements of our long-term memory and the process we use them) respond to a graphic organisation and gather together following accurate patterns called cliques (neural networks).

electroencephalography (eeg) with very high spatial resolution (hr) (eeg-hr, 256 electrodes) allows for a better understanding of the global and local activity of the cerebral neocortex. in 2012, following publications by claude berrou and vincent gripon's internet, introducing new principles of coding information based on graphical representations in connectionist networks, we approached this team to test biological plausibility of this theory in vivo with eeg. the central concept is the mental information, defined as all elements of knowledge acquired by the long-term memory on which the reason can build to try to respond to new problems. according to this new theory, these elements of knowledge called qualia or features should be connected within cliques networks. however, we currently do not have graphs comparing methods to measure a good index of both spatial and topological similarity between graphs with high resolution electroencephalography. for this new study, we propose to combine the strengths of several existing methods of graph comparison which, on top of this, will be especially adapted to the specific context of the analysis of the graphs in the cerebral cortex. the skills used are diverse: information theory, mathematics, graph theory, computer science, neuropsychology, signal processing and neurology.

Eligibility criteria:
inclusion criteria: * 18 years and older * right-handed ; * french native speaker * having given written informed consent exclusion criteria: * presence of any psychiatric, neuropsychological and developmental disorder * any uncorrected visual impairment * any trouble or delay in learning to read / speak french * fully bilingual or multilingual * medication, treatment and / or substances that may alter or modify brain functions * pregnancy, breast feeding * persons under major legal protection and/or deprived of liberty mri-related criterions * cardiac pacemaker or implanted defibrillator * iron-magnetic surgical clips * cochlear implant * intra-ocular or brain foreign bodies * less than 4 weeks-old stents, less than 6 weeks-old osteosynthesis materials * claustrophobia
the effect of melatonin administration on sedation level as adjuvant to propofol

Conditions: TBI (Traumatic Brain Injury)

Summary: this study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.

38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. in both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bispectral index (bis), then propofol infusion started at a rate of 1mglkglhr as a maintenance and rate adjusted according to our targeted sedation level, melatonin 10 mg tablet was crushed and mixed with 20 ml of water and administrated through a nasogastric tube followed by another 20 ml to flush out the residue for (melatonin group). while (control group) received a placebo tablets by the same waybis value and propofol infusion rate was recorded over 12 hours.

Eligibility criteria:
inclusion criteria: * age group from 18 to 65 * both sexes * patients on a mechanical ventilation and need sedation * patients who are vitally stable exclusion criteria: * gastro intestinal tract impractabililty * pregnant female * vitally unstable patients who cannot tolerate propofol infusion

Keywords: melatonin
hemodynamic effects of cold versus warm fluid bolus

Conditions: Temperature Change, Body; Hypovolemia

Summary: fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. it is unclear whether the temperature of the fluid has an impact on the hemodynamic response. the aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures.

a randomized, controlled, cross-over study in 21 healthy volunteers. the participants will receive a fluid bolus of 500 ml ringer's acetate at either 22°c or 38°c over 15 minutes in a randomized order. non-invasive measures will be made of cardiac index, mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart and pulse rate, saturation and temperature. hemodynamic measure will be made using the clearsight® system. measurements will be made during 120 minutes. the second session will take place at least one day later, and the participant will then receive the other fluid temperature.

Eligibility criteria:
inclusion criteria: - volunteers 18 years or older previously healthy exclusion criteria: * american society of anesthesiologists classification 2 or above. * known pregnancy

Keywords: fluid therapy
safety and immunological response rate study of theratope® vaccine in metastatic breast cancer patients

Conditions: Breast Neoplasms

Summary: the purpose of this study is to examine the immunological response rate to administration of the theratope® vaccine in women with stable metastatic breast cancer who are being treated with aromatase inhibitors or faslodex® and who do not require chemotherapy. post-menopausal women on aromatase inhibitors or faslodex® alone and pre-menopausal women on aromatase inhibitors plus luteinising hormone-releasing hormone (lh/rh)-agonist may be eligible to be enrolled. patients must not have had radiotherapy or major surgery within four (4) weeks prior to entering the study. information about the safety and tolerability of administration of the theratope® vaccine will also be gathered during the course of the study.


Eligibility criteria:
inclusion criteria * histopathologically confirmed breast cancer * documented stage iv disease * estrogen and/or progesterone-receptor positive * stable disease on aromatase inhibitor or faslodex® treatment begun at least 12 weeks prior to enrolment * performance status, ecog = 0 or 1 * life expectancy \> 12 weeks * history of freedom from progression for at least 6 months following surgery with a curative intent or for at least 6 months during adjuvant chemotherapy, adjuvant radiotherapy or adjuvant hormonal therapy such as tamoxifen/toremifene treatment * no radiotherapy or major surgery within 4 weeks prior to enrolment exclusion criteria * pregnant or lactating * known brain metastasis * bone marrow involvement as the only site of metastasis * first line chemotherapy for stage iv disease * past or current cancer other than breast cancer, except for curatively treated basal cell cancer or in situ cancer of the cervix with no evidence of disease * autoimmune disease, e. g., type i juvenile onset diabetes mellitus, antibody positive rheumatoid arthritis, grave's disease, lupus, crohn's disease, ibd, hashimoto's thyroiditis * known intercurrent infections (including hbv or hcv) or immunosuppression \[human immunodeficiency virus (hiv) or other conditions\] or clinical evidence of these conditions * other significant active infection * pleural effusions and/or ascites requiring paracentesis every 2 weeks or more frequently * splenectomy * concurrent treatment with chemotherapeutic agents other than low-dose cyclophosphamide used in this study * treatment with interferons (ifns), cytokines, systemic steroids or other biologicals within 4 weeks prior to enrolment * receipt of another investigational drug within 30 days of enrolment * known allergy to shellfish * known allergy to soy beans or soy products * known hypersensitivity to polysorbate 80 * known hypersensitivity to the study drugs * legal incapacity or limited legal capacity

Keywords: cancer vaccines aromatase receptors, estrogen receptors, progesterone
efficacy and safety evaluation of an2690 topical solution to treat onychomycosis of the toenail

Conditions: Onychomycosis of Toenails

Summary: the purpose of this study is to determine whether an2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail * koh positive at screening * willingness not to use any other products including nail polish applied to the toenails during the study * women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period exclusion criteria: * concurrent or recent use of certain topical or systemic medications without a sufficient washout period * history of any significant chronic fungal disease other than onychomycosis * significant confounding conditions as assessed by study doctor * participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * pregnancy or lactation

Keywords: onychomycosis nail fungus toenail fungus fungal nail hyperkeratosis nail infection nail treatment toenail infection toenail treatment foot dermatoses fungal culture onycholysis podiatrist podiatry subungual tinea unguium antifungal anti-fungal dermatologist dermatology dermatophyte distal subungual onychomycosis yellow nail thick nail brittle nail crumbling nail discolored nail weak nail
dietary reduction of ages to prevent cognitive decline in elderly diabetics

Conditions: Cognitive Decline; Aging; Type 2 Diabetes

Summary: basic science and observational human studies suggest that high conentrations of circulating advanced glycation end-products (ages) may promote cognitive decline in older adults. the purpose of this pilot study is to test the methodology and feasibility of a dietary intervention to lower ages in elderly diabetics in order to lay the foundations for a future fully powered randomized clinical trial (rct).to this end, the present study is focused on recruitment strategies, adherence to an innovative intervention in older adults and study methods. an exploratory aim will be the effect of the intervention on cognition and cerebral blood flow in order to obtain necessary data to estimate effect-size for a future fully-powered rct.


Eligibility criteria:
* above the age 65 * t2d diagnosis * no dementia (i.e mci or cognitively normal ) * not receiving cholinesterase inhibitors * no other neurological (e.g. stroke, parkinson's disease) or psychiatric conditions (e.g. schizophrenia, depression) that may affect cognition * dietary age levels \> 13ku * not participating in another clinical trial * an informant that is willing to actively support the participant throughout the study exclusion criteria: * dementia * stroke * other major neuropsychiatric condition that might affect cognition
testing educational videos on conservative kidney management

Conditions: Kidney Disease, Chronic

Summary: this study aims to test the efficacy of a series of just-in-time educational videos on topics related to ckm (ckm-empower) in improving nephrology providers ability to provide ckm.

conservative kidney management (ckm) is an important therapeutic alternative for patients who do not wish to pursue dialysis for their advanced chronic kidney disease (ckd). despite a growing body of evidence and clinical services to support patients who do not wish to pursue dialysis, nephrologists receive very limited training in ckm. this is a randomized trial of nephrology fellows that utilizes surveys to assess their change in knowledge, confidence and practice of providing ckm with receipt of ckm-empower. the investigators hypothesize that the ckm-empower will improve nephrology fellows' knowledge and confidence with delivering key elements of ckm. investigators will recruit 126 nephrology fellows from us fellowship programs and randomize participants in a 1:1 fashion to either receipt of the ckm-empower or non-receipt. participants will complete web-based surveys to assess knowledge and confidence with providing ckm between groups.

Eligibility criteria:
inclusion criteria: * nephrology fellow enrolled in us nephrology fellowship training program exclusion criteria: * none

Keywords: education conservative kidney management provider training
anidulafungin versus fluconazole for the prevention of fungal infections in liver transplant recipients

Conditions: Mycoses; Fungemia; Central Nervous System Fungal Infections; Lung Diseases, Fungal

Summary: the purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients

a number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation. retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients. most invasive fungal infections in these high-risk patients occur within the first month posttransplant. studies utilizing universal prophylaxis have primarily employed fluconazole. a recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans candida spp. in patients receiving prophylaxis. the availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. anidulafungin has demonstrated good safety profile. we hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.

Eligibility criteria:
inclusion criteria: * liver transplant recipient at increased risk for infection increased risk include any of the following: * retransplantation * renal replacement therapy (dialysis), * post transplant abdominal surgery (within 21days) * receipt of corticosteroids for greater than 14 days within the 4 weeks -preceding transplant * icu care for greater than 48 hours at the time of transplantation * colonization with candida sps within 4 weeks of transplantation * requirement of 15 units or greater of packed red cell transfusions * intraoperative time exceeding 6 hours exclusion criteria: * hypersensitivity to azole or echinocandin antifungal agents * receipt of systemic antifungal therapy within 4 weeks prior to transplantation
icg and sln mapping

Conditions: Breast Cancer

Summary: the purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (icg)-fluorescent imaging through the asimov imaging platform, to perform sentinel lymph node biopsy. participants in this research study will be undergoing a sentinel lymph node biopsy as part of surgical treatment for breast cancer. active participation will last through the post-operative visit.

in this study, the sentinel lymph node biopsy will be performed with radioactive tracer (technetium-99 sulfur colloid) and blue dye, which is standard of care. decisions will be made during surgery about which lymph nodes to remove using information from the radioactive tracer and blue dye alone. for this research, icg fluorescence dye during participant's surgery will also be used. after anesthesia has started, the icg fluorescence dye will be injected in the breast along at the edge of the areola in the same location as the radioactive tracer and blue dye injections. the breast and axilla will then be imaged with the asimov imaging platform to look for the sentinel lymph nodes.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosis of clinical t1 or t2 breast cancer clinically node negative breast cancer requiring surgical lymph node evaluation * surgery at university of wisconsin hospital and clinic exclusion criteria: * pregnant: it is not known whether indocyanine green can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. women of child-bearing age will undergo a urine pregnancy test on the day of surgery, which is standard of care prior to anesthesia. * breastfeeding: it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when indocyanine green is administered to a nursing woman. study team will exclude women who are breastfeeding. * unable to provide informed consent * allergy to indocyanine green * history of ipsilateral breast or axillary surgery

Keywords: breast cancer sentinel lymph node icg fluorescence
hla-mismatched microtransplantation for high risk acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: to compare the antitumor efficacy and toxicity of idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized hla-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: 1. having signed informed consent 2. diagnosis was based on the french-american-british (fab) and who criteria. 3. age ≥ 7 years old 4. age \< 60 years old exclusion criteria: 1.patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia

Keywords: acute myeloid leukemia idarubicin microtransplantation
the effect of rehabilitation for patients living with an implantable cardioverter defibrillator

Conditions: Quality of Life

Summary: the purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with implantable cardioverter defibrillators (icd). hypothesis: the outpatient nursing programme will increase the perceived health and quality of life; improve the management of life from a patient perspective; reduce fear of exercise and increase physical capability and reduce the number of treatment-demanding arrhythmias.

implantable cardioverter defibrillators (icd) are used in the treatment of life-threatening heart arrhythmia and the prevention of sudden cardiac death (scd). the icd terminates arrhythmia by delivering therapy in the form of electrical impulses to the heart. patients have described the high energy shock administered by the devise as feeling like a painful kick in the chest. patients, who receive an icd are very much protected against scd and it is assumed that they are less worried and effected by their heart disease than others. that is not correct though. studies have shown, that living with an icd can lead to anxiety, fear of shock and avoidance of situations, places and objects that are associated to shock. it often leads to social isolation, avoidance of physical activity and mood-disturbances. the purpose of this study is to describe the effect and meaning of an outpatient-nursing programme including physical activity for patients with icd. hypothesis: see above intervention: the outpatient nursing programme has a duration of 1 year and is directed towards parameters that icd reportedly affect. the focus is prevention of the known risks and problems. the content is partly information and education in managing an icd, partly emotional reactions and further discussion of handling life with icd. 3-month into the program physical training lead by a physical therapist is started. it is optimal whether to carry out the twice-weekly physical training program at home or at the hospital. 180 patients, who get an icd transplanted at copenhagen university hospital, rigshospitalet, are included in the study prior to discharge. 90 patients in the intervention group and 90 controls. using questionnaires, qualitative interviews, work-test, 6 mwt and decoding icd the effect and meaning of the programme is evaluated.

Eligibility criteria:
inclusion criteria: * in-patients at copenhagen university hospital who just received an icd for the first time. exclusion criteria: * patients who: * do not understand the instructions, * are under 18 years old, * are diagnosed with a mental disease, * suffer from a competing disease, * can not participate in physical training.

Keywords: icd rehabilitation