Kornimate/medical-research-clean huggingface dataset:
breast cancer psma pet

Conditions: Triple Negative Breast Cancer

Summary: the purpose of this research is to determine the expression of prostate specific membrane antigen(psma) in metastatic triple negative breast cancer (tnbc) patients using fludeoxyglucose f18 (fdg) pet/ct as the gold standard. the investigators hypothesize that most lesions in metastatic tnbc are psma-avid; and thus psma-based radionuclide therapy can be a valid treatment option for tnbc, and clinical trials can be designed for this purpose. thirty metastatic tnbc patients will be enrolled and will be on the study for maximum of 4 weeks.

prostate specific membrane antigen (psma) is not only expressed in prostate cancer and its metastases, but also it is expressed on the neovasculature of many other solid tumors including gastric, lung, adrenal, bladder and renal cell carcinomas. also, there is evidence that breast carcinomas express psma, although this has not been specifically studied in the metastatic tnbc. the study involves a total of 2 visits and on each visit, patients will undergo a pet imaging. each patient will first undergo an (fdg) pet/ct and then in few days will undergo an 18f-dcfpyl-pet/ct. the pet scanner is a large machine with a hollow tube that will be used to see how f18 fdg is taken up into the tumor and other tissues. the patients will be asked to lie on the back on a special table that slides into the tube. the sides of the tube will be close to the body. at the first visit patients will be in this scanner for approximately 20 minutes. the study will evaluate the expression of psma via 18 f-dcfpyl-pet/ct in metastatic tnbc patients and compare it with lesion detection rate of fdg pet/ct. psma-avid lesions will be detected using the novel agent 18 f-dcfpyl and concordance rate with fdg-avid lesions will be calculated. the standardized uptake values (suv) of each lesion on both fdg pet/ct and 18f-dcfpyl-pet/ct will be compared to find a correlation between tumor aggressiveness (lesion suv on fdg pet/ct) and tumor angiogenesis (lesion suv on 18 f-dcfpyl-pet/ct).

Eligibility criteria:
inclusion criteria: * female \>= 18 years of age * patients in distantly metastatic tnbc based on the initial diagnosis biopsy. * patient should have fdg positive metastatic lesions on the initial pet/ct scan performed in this study to be further included. exclusion criteria: * patients with known active other malignancy. * unable to tolerate pet/ct procedure. * pregnant or breastfeeding. * patients with any medical condition that might compromise the safety of subject during pet acquisitions.

Keywords: breast cancer, psma expression, pet imaging
phase 1 pharmacokinetics, safety, and tolerability study

Conditions: Pain

Summary: a phase 1, randomized, double-blind, placebo-controlled, ascending single and multiple oral dose study of the pharmacokinetics, safety, and tolerability of xg005 in healthy volunteers.

this is a randomized, double-blind, placebo-controlled study which will investigate the pk, safety, and tolerability of four ascending single and multiple oral doses of xg005 in healthy subjects. the trial consists of two parts: a single ascending dose (sad) pk evaluation (part 1) and a multiple ascending dose (mad) pk evaluation (part 2). approximately 32 subjects will be enrolled sequentially into a total of 4 ascending dose levels in each part.

Eligibility criteria:
inclusion criteria: 1. healthy males or females between 18 and 55 years of age 2. bmi 18.0 to 30.0 kg/m2 3. non-pregnant, non-breastfeeding female subjects exclusion criteria: 1. unstable or severe illness 2. history of, or current treatment for, gi disease 3. clinically significant history of medical condition associated with gi events 4. history of or current glucose intolerance or gestational diabetes 5. lifetime history of suicidal behavior 6. creatinine clearance \< 90 ml/min 7. any elevation of liver function tests 8. creatine kinase (ck) value of greater than 1.5 times the upper limit 9. leucocytes or lymphocytes less than 1.5 times the lower limit of normal 10. positive hepatitis b surface antigen, hcv, or hiv
effect of a novel protein ingredient combined with oral nutritional supplement on appetite in older adults

Conditions: Aging; Appetite Loss; Undernutrition

Summary: reduced appetite can occur with ageing and is linked to a higher risk of undernutrition, poorer physical function and becoming frail. strategies to increase appetite are needed to improve healthy ageing. this study follows on from previous work which has found a novel ingredient in whey protein (derived from whole milk) that may help to increase appetite and energy intake. this study will compare the effects of the ingredient added to an oral nutritional supplement (ons) versus the ons alone versus the ingredient dissolved in water on appetite in older adults. by studying this nutrition supplement in older adults, this will help to provide greater information on possible nutrition strategies to improve healthy ageing.


Eligibility criteria:
inclusion criteria: * community-dwelling, * age 60+ years * poor appetite (simplified nutritional appetite questionnaire (snaq) score \</=14, answer a, b or c to q.1 on snaq or answer b, c, or d to ces-d question regarding poor appetite in the past week) * bmi 20-25kg/m2 exclusion criteria: * current medical condition or medication known to impact appetite or energy intake * other medical condition that would impact study participation and outcomes, as judged by the study investigator. * heavy smoker (\>10/day) * inability to come to study centre * currently participating in another intervention study * lacking informed consent * allergic to or unwilling to consume any of the study test foods * loss of taste or smell associated with covid-19 * unable to walk across a room

Keywords: appetite poor appetite ageing whey protein hydrolysate visual analogue scale energy intake ghrelin oral nutritional supplement dairy
austrian wearable cardioverter defibrillator registry

Conditions: Heart Failure; Ventricular Dysfunction; Sudden Death; Sudden Cardiac Arrest; Ventricular Tachycardia; Ventricular Fibrillation

Summary: background: the wearable cardioverter defibrillator (wcd) is an established treatment option for patients at high risk for ventricular tachycardia / ventricular fibrillation (vt/vf), either in whom this risk may only be temporarily present, or in patients at high risk for sudden cardiac death (scd) or after vt/vf in whom an implantable cardioverter defibrillator (icd is currently not possible for other reasons (infection, recent mi \<40days, recent pci/cabg \< 3months etc.). methods: comprehensive registry including all patients in austria who received a wcd in 2010-2016.

observational study to describe wcd indications, event rates, inappropriate shock rates and follow up (including icd rate, shock rate, morbidity and mortality) in all austrian wcd patients

Eligibility criteria:
inclusion criteria: * patients, with a prescribed wcd according to guidelines in an austrian center

Keywords: wearable cardioverter defibrillator lifevest sudden death defibrillator
efficacy and safety of tamibarotene(am80) for lupus nephritis

Conditions: Lupus Nephritis

Summary: an open-label study to evaluate the efficacy and safety of orally administered tamibarotene to patients of lupus nephritis

tamibarotene is a synthetic retinoid presently approved in japan for the treatment of apl, and in us, europe and china it is still under development for apl. compared to other retinoid drugs available, tamibarotene has not just a higher activity as a retinoid, but also shows a higher receptor selectivity towards the retinoic acid receptor (rar) subtypes alfa and beta, but not gamma. all trans retinoic acid (atra) and its derivatives are usually pan-agonists to these subtypes, and often are know for the irritation to the skin as one of their major side effects which is due to the rar gamma subtype. moreover, unlike atra tamibarotene does not cause induction of drug metabolism by crabp. tamibarotene is known to moderate t1/t2 balance as well as treg/th17 balance through binding rar-alfa receptor, and shows efficacy to various autoimmune and inflammatory animal models. in the preliminary clinical research, patients with lupus nephritis for whom prednisolone treatment was not sufficient enough was treated with oral administration of atra to show a remarkable decrease in their protein urea (ref. kinoshita et al, am.j.kidney dis., 2009 jul 21). based on these results, the investigators plan by this study to evaluate the efficacy of tamibarotene together with the safety to the patients of lupus nephritis. tamibarotene is used clinically in japan since 2005. it's side effects are known to be similar to that of other clinically used retinoids.

Eligibility criteria:
inclusion criteria: * steroid refractory lupus nephritis * more than 10mg of steroid failed to control disease activity * patients who failed to reduce the amount of steroid * patients who couldn't increase the amount of steroid due to side effects * urine protein creatinine raio \> 0.5 or rbc in urine \>= 6 /hpf * anti dsdna antibody \> 10 iu/ml or complement c3 \< 84 mg/dl * patients willing to take contraceptive measures throughout the study and for female patients two years after the study and for men six months after the study. exclusion criteria: * pregnant or breastfeeding female patients * hepatic failure patients * triglyceride \> 500 mg/dl * patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 8 weeks prior to test drug administration * patients who received cyclophosphamide puls within 6 months prior to test drug administration * patients with diabetics (hba1c \> 8.0%) * serum creatinine ≧1.5mg/dl * cns( central nerve system) lupus patients

Keywords: lupus nephritis sle retinoid tamibarotene
efficacy and safety of vonoprazan as first-line treatment for helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: this study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for helicobacter pylori(hp) eradication, as well as the safety and economic benefits.

vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric ph maintains for a longer period. vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising. this study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups. group a: vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days group b: vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days group c: esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.

Eligibility criteria:
inclusion criteria: 1. helicobacter pylori-positive participants determined by ¹³c-urea breath test, ¹⁴c-urea breath test, he stain or bacterium culture 2. with no historical treatment for helicobacter pylori infection. exclusion criteria: 1. administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including h2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion 2. active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc. 3. with previous esophageal or gastric surgery 4. with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases 5. allergy to any of the study drugs 6. pregnancy or in lactation 7. participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher

Keywords: helicobacter pylori vonoprazan
autologous prefabrication of body surface tissues/ organs(e.g. joint)

Conditions: Soft Tissue Infections; Intentional Self Harm by Other Specified Means

Summary: the purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges

in the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. these uncertainties have hampered road to the clinical application. as the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.

Eligibility criteria:
inclusion criteria: * with body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction. exclusion criteria: * evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration * history of delayed healing, radiational therapy; * significant renal, cardiovascular, hepatic and psychiatric diseases; * significant medical diseases or infection (including but not limited to the carrier of hepatitis b virus or hiv); * bmi \>30; * history of any hematological disease, including leukopenia, thrombocytopenia, or thrombocytosis; * evidence of malignant diseases * unwillingness to participate.

Keywords: self-regeneration, in vivo tissue prefabrication,
a study of zn-c3 in patients with ovarian cancer

Conditions: Solid Tumor; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: this is a phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (pk), and pharmacodynamics of zn-c3 in combination with other drugs.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed high-grade serous epithelial ovarian carcinoma, fallopian tube, or peritoneal carcinoma. * subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. * measurable disease per recist version 1.1. * adequate hematologic and organ function as defined by the following criteria: 1. anc ≥ 1.5 × 10\^9/l; excluding measurements obtained within 7 days after daily administration of filgrastim/sargramostim or within 3 weeks after administration of pegfilgrastim. 2. platelet count ≥ 100 × 10\^9/l; excluding measurements obtained within 3 days after transfusion of platelets or within 3 weeks after administration of platelet growth factors. 3. alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤3 × upper limit of normal (uln). if liver function abnormalities are due to underlying liver metastases, ast and alt ≤ 5 x uln. 4. total serum bilirubin ≤ 1.5 × uln or ≤ 3 × uln in the case of gilbert's disease. 5. serum creatinine ≤ 1.5 x uln or creatinine clearance (crcl) ≥ 60 ml/min. exclusion criteria: * histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor. * any of the following treatment interventions within the specified time frame prior to cycle 1 day 1: 1. major surgery within 28 days. 2. radiation therapy within 21 days. 3. autologous or allogeneic stem cell transplant within 3 months. a serious illness or medical condition(s) including, but not limited to, the following: 1. brain metastases that require immediate treatment or are clinically or radiographically unstable. 2. myocardial impairment of any cause. 3. significant gastrointestinal abnormalities. 4. active or uncontrolled infection. 5. any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (ct) scan, recent hospitalization for small bowel obstruction within 3 months prior to cycle 1 day 1, or recurrent paracentesis or thoracentesis within 6 weeks prior to cycle 1 day 1. * subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.

Keywords: solid tumor
neoadjuvant immunotherapy combined with the anti-gdf-15 antibody visugromab to treat muscle invasive bladder cancer

Conditions: Bladder Cancer; Adult Solid Tumor

Summary: this is a multi-center, stratified and single-blinded phase 2 study of neoadjuvant immunotherapy in combination with the antigdf15 antibody visugromab (ctl-002) for the treatment of subjects with mibc set to undergo radical cystectomy (rc)/re-turbt who cannot receive or refuse to receive cisplatin-based chemotherapy.


Eligibility criteria:
main inclusion criteria: * signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * male or female aged ≥ 18 years. * histopathologically confirmed urothelial carcinoma. * clinical stage t2-t4an0m0 mibc. * ineligible for cisplatin therapy per modified galsky criteria or refuses cisplatin-based chemotherapy. * eligible for radical cystectomy. * pretreatment tumor material from transurethral resection of the bladder tumor (turbt) must be available. * eastern cooperative oncology group (ecog) performance status 0-1. * adequate organ function (bone marrow, hepatic, renal function and coagulation). main exclusion criteria: * pregnant or breastfeeding. * received prior radiotherapy on the bladder tumor. * received a partial cystectomy. * any prior systemic anti-cancer therapy including investigational agents and immunotherapy. * pre-existing arrhythmia, uncontrolled angina pectoris, uncontrolled heart failure (nyha) grade iv, any myocardial infarction/coronary event, cns-ischemic event and any thromboembolic event at any time \< 6 months prior to screening or presence of uncontrolled heart failure nyha grade iii or higher. * left ventricular ejection fraction (lvef) \< 50% measured by echocardiogram or muga. * qtcf ≥ 470 ms regardless of sex. * any active autoimmune requiring systemic immunosuppressive treatments. * any history of non-infectious pneumonitis \< 6 months prior to screening. * any active inflammatory bowel disease such as crohn's disease or ulcerative colitis which are generally excluded or active autoimmunthyroiditis present \< 6 months prior to screening. * history of cns disease such as stroke, seizure, encephalitis, or multiple sclerosis (\< 6 months prior to screening).

Keywords: ctl-002 visugromab gdf-15
mortality of sepsis in swedish intensive care units 2008-2016

Conditions: Sepsis

Summary: a study of short and long term mortality in patients treated with or without a diagnosis of sepsis in swedish intensive care units (icu) 2008 - 2016. the cohort is characterized with regard to chronic comorbidity, severity of acute illness and demographic factors, and outcome is adjusted for these factors. changes in mortality during the period are studied.

all adult patients admitted to a general icu included in the swedish intensive care registry (a majority of all icus in sweden) between 2008-01-01 and 2016-10-18 are followed for one year and any deaths are registered. data on illness severity scores, age, sex, admitting hospital and duration of icu stay are recovered. data are linked with the inpatient registry of the swedish board of health and welfare (socialstyrelsen), and any discharge diagnoses from the last 5 years preceding icu admission are recovered. these are used to assess chronic comorbidity. mortality, adjusted for severity of illness, comorbidity and patient factors, is studied and any changes over time during the inclusion period are assessed. the data in the swedish icu registry are entered by the treating icu physicians and include severity of illness (simplified acute physiology score (saps)3), selected chronic comorbidity, sex and date of birth, icu stay and selected interventions and complications. relevant international classification of diseases (icd)-10 diagnoses are required and assessment of the occurrence of severe sepsis or septic shock, during the inclusion period defined according to the american college of chest physicians/society of critical care medicine (accp/sccm) (sepsis 2) criteria, is mandatory when entering data.

Eligibility criteria:
inclusion criteria: * admission to a swedish general icu (excluding specialized cardiothoracic, neurosurgical, pediatric and burns units) between 2008-01-01 and 2016-10-18 * episode registered in swedish intensive care registry exclusion criteria: * age \< 18 years * readmission (only first episode during the period included)
contact lenses and myopia

Conditions: Myopia

Summary: the objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. this will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses.


Eligibility criteria:
inclusion criteria: * 7 to 15 years of age * refractive error between -1.00 and -8.00 d sphere, with less than or equal to 1.00 d astigmatism * corrected visual acuity of 20/25 or better in each eye exclusion criteria: * ocular or systemic disease known to affect accommodation or vision * convergence or accommodative disorder, or any strabismus * use of oral or topical medications known to affect accommodation

Keywords: pediatrics contact lenses