Kornimate/medical-research-clean huggingface dataset:
gliasite 1-3 mets study

Conditions: Brain Metastases

Summary: this study has been designed to compile information on the efficacy of the gliasite rts combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.

data relevant to the evaluation the effectiveness of the gliasite rts for a resected dominant brain metastases will be collected. the gliasite rts is a radionuclide applicator and liquid radionuclide (iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. in this case, it will irradiate the resected margins. brain metastases not surgically removed will be then treated with radiosurgery

Eligibility criteria:
inclusion criteria: * have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced mri scan * have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report * have a karnofsky performance status (kps) \>=70 * have systemic disease which is judged to be stable and has been staged within the last 6 weeks * have a life expectancy of \>= 6 month, based upon extent of systemic disease * be at least 18 years of age give informed consent (or have legal representative give informed consent) exclusion criteria: * be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor. * be receiving or have plans to receive external beam radiation therapy to the brain. * have received prior conventional or investigational systemic agents, including the use of gliadel wafers or temodar, for the treatment of the brain metastasis. * be pregnant or breast-feeding. * have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia. * have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy. * have histology of lymphoma or small-cell lung cancer.

Keywords: gliasite brain metastases 1-3 mets
a study to evaluate azp531 in healthy volunteers, overweight/obese volunteers and patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: objectives: primary objectives * to investigate the safety and tolerability of single ascending doses of azp- 531 in healthy volunteers. * to investigate the safety and tolerability of single and multiple ascending doses of azp-531 in overweight/obese volunteers. * to investigate the safety and tolerability of single and multiple ascending doses of azp-531 in patients with type 2 diabetes mellitus. secondary objectives • to determine the plasma pharmacokinetic (pk) profile of azp-531 after single and multiple doses. exploratory objectives • to obtain exploratory data on the effects of azp-531 on the pharmacodynamic (pd) markers of blood glucose, interstitial glucose, insulin, and plasma acylated ghrelin (ag) and unacylated ghrelin (uag)


Eligibility criteria:
inclusion criteria: * part a: healthy male volunteers, aged 18 to 50 years (inclusive) with a body mass index (bmi) of 20 to 28 kg/m2 (inclusive). * part b: female (of non-childbearing potential) and male overweight/obese volunteers, aged 18 to 65 years (inclusive) with a bmi of 28 to 38 kg/m2 (inclusive). * part c: female (of non-childbearing potential) and male patients with a confirmed diagnosis of type 2 diabetes mellitus for at least 3 months exclusion criteria: * part a: females and male volunteers who smoke and/or use other nicotine products within 6 months of screening are excluded. * part b: current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) and any clinically significant abnormalities in physical examination, electrocardiogram (ecg), clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the investigator. * part c: current or ex-smokers with a smoking history of greater than 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year), any clinically significant abnormalities other than those attributed to type 2 diabetes mellitus in physical examination, ecg, clinical chemistry, haematology, coagulation or urinalysis results at screening or on admission, as judged by the investigator, and estimated glomerular filtration rate \<40 ml\*min-1\*1.73m-2 calculated by the modification of diet in renal disease formula.

Keywords: type 2 diabetes mellitus
biomebakery project

Conditions: Cognition; Affect (Mental Function); C Reactive Protein

Summary: this study aims to investigate the chronic effects of prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy adults aged 60-75 years with mild to moderate subjective cognitive complaints.

this study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of an 12 week prebiotic fibre-fortified functional bakery product on cognitive, affective, inflammatory, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. seventy four participants will be randomised (1:1 ratio, matched by age, sex, and fibre intake) to intervention or placebo groups where they will be consuming a prebiotic fibre-fortified functional bakery product (containing 10g prebiotic fibre/day) or a regular bakery product (containing 0g prebiotic fibre/day), respectively, for 12-weeks. outcome measures will be acquired before and after a 12-week chronic supplementation. these will include cognitive measures of overall cognitive functioning, immediate and delayed verbal memory, executive functions; affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; inflammatory measure of high sensitivity c-reactive protein (hs-crp); metabolic measures of lipid profiles (total-c, ldl-c, hdl-c, triglycerides), hemoglobin a1c (hba1c) and systolic and diastolic blood pressure; and anthropometric measures of height, weight, hip and waist circumference.

Eligibility criteria:
inclusion criteria: * aging between 60-75 years old * having normal vision and hearing * having a normal body mass index (bmi\<30) * having mild to moderate subjective cognitive complaints * consuming bread (5 or more times a week) exclusion criteria: * smoking * having food allergies * following restrictive and/or unbalanced diets * changing dietary intake majorly in past month * being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders * being diagnosed with any cardiometabolic diseases (including type ii diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease * being anaemic * currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors * currently consuming prebiotic or probiotic supplements * continuous antibiotic use for \> 3 days within 1 month prior to enrolment * continuous use of weight-loss drug for \> 1 month before screening * having a significant gastrointestinal (gi) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years * having a high fibre intake defined as \> 20g of fibre/day * wheat and/or gluten intolerance and having coeliac disease

Keywords: prebiotics fibre cognition depression anxiety inflammation
stratification of chronic alcoholic liver diseases (scale study)

Conditions: Alcoholic Liver Disease

Summary: recent years, the european association for the study of the liver-chronic liver failure (easl-clif) has defined and graded acute-on-chronic liver failure (aclf) based on canonic study which enrolled cirrhotic patients with acute decompensation. however, the characteristics and definitions of aclf in non-cirrhotic patients with acute deterioration of liver function and organs injury or failure remain to be clear. as for patients who don't fulfil aclf criteria, there might be a subgroup with high risk of progression (\>25%) and a moderate 4-week mortality rate (\>7%), which can be defined as "pre-aclf", while the others are just chronic liver disease with "mere" liver injury or decompensation. this stratification system was primarily verified in a previous retrospective cohort which enrolled hepatitis b patients only. the stratification criteria for chronic alcoholic liver disease needs to be further defined in detail. therefore, investigators plan to prospectively recruit 3000 chronic alcoholic hospitalized patients with liver dysfunction from 24 hepatology departments in china, aiming to propose a stratified diagnostic system for chronic alcoholic patients based on organs injury. meanwhile, risk factors of disease progression and short-term mortality will be analyzed, while characteristics and prognosis will be compared between patients with and without cirrhosis.


Eligibility criteria:
inclusion criteria: 1. long-term alcohol consumption (at least one of the followings): 1. \>40g/d for male and \>20g/d for female, at least for 5 years; 2. \>50g/d for at least 6 months; 2. liver injury (at least one of the followings): 1. ast\>1.0 uln and ast\>alt; 2. tbil\>2.0mg/dl; 3. ascites; 4. hepatic encephalopathy; 5. esophageal variceal bleeding; 6. hypersplenism exclusion criteria: 1. younger than 18 or older than 80; 2. other etiologies rather than alcoholic liver disease, including but not limited to the followings: 1. acute or chronic virologic hepatitis: hepatitis a-e, hepatitis caused by cmv,ebv, etc. 2. autoimmune hepatitis, including psc, pbc, aih, igg4 related liver disease 3. inherited metabolic liver diseases: wilson disease; 4. others: schistosomiasis 3. hiv antibody positive; 4. malignancies including but not limited to hcc; 5. pregnancy; 6. hospital stay less than 24h; 7. refuse to sigh the informed consent; 8. combined with other improper situations determined by investigators.
a clinical research of car t cells targeting epcam positive cancer

Conditions: Colon Cancer; Esophageal Carcinoma; Pancreatic Cancer; Prostate Cancer; Gastric Cancer; Hepatic Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of epcam-specific car t cells infusion for epcam positive cancer.

this study is being conducted to evaluate the safety and efficacy of chimeric antigen receptor (car) t cells targeting epcam in treating patients with epcam positive cancer. in the research, the investigators design a novel car consists of a epcam targeting antibody scfv with two intracellular signaling domains derived from cd3 zeta and cd28. autologous t cells will be gene-engineered with the car gene using a lentivirus vector. prior to t cell infusion, the patients will be subjected to preconditioning treatment. the infusion dose is (1-10)×106 epcam-car positive t cells/kg, and the specific cells numbers depends on the situation of individual car-t cells preparation. the way of infusion is vascular interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to 30min, and the specific time depends on patent's tumor-burdened state. after t cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of car t cells and efficacy.

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory epcam positive cancer. 2. kps \> 60. 3. life expectancy\>3 months. 4. gender unlimited, age from 18 years to 80 years. 5. assessable lesions with a minimum size of 10mm by ct scan or mri. 6. acceptable organ function hematology: * absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim. * white blood cell (wbc) (\> 2000/mm\^3). * platelet count greater than 50,000/mm\^3. * hemoglobin greater than 9.0 g/dl. 7. no other serious diseases(autoimmune disease, immunodeficiency etc.). 8. adequate cardiac function (lvef ≥ 40%). 9. no other tumors. 10. patients volunteer to participate in the research. exclusion criteria: 1. allergic to cytokines. 2. uncontrolled active infection. 3. acute or chronic gvhd. 4. mods. 5. treated with t cell inhibitor. 6. hiv affected. 7. pregnancy.
safety and efficacy evaluation of fx-1006a in patients with v122i or wild-type transthyretin (ttr) amyloid cardiomyopathy

Conditions: ATTR-CM; TTR-CM

Summary: open-label safety and efficacy evaluation of fx-1006a in patients with v122i or wild-type transthyretin (ttr) amyloid cardiomyopathy. patients who successfully complete fx1b-201 will report to the clinical unit on day 0 to sign the informed consent form and determine eligibility for protocol fx1b-303. in addition, on day 0, patients will have their entrance criteria reviewed, and medical histories and demographic characteristics obtained. the physical examination (including weight and vital signs) and the relevant end of study clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total bilirubin, international normalized ratio, troponin i, troponin t, and amino-terminal b-type natriuretic peptide) from protocol fx1b-201 will be used for protocol fx1b-303. if more than 30 days has elapsed between the final study visit of protocol fx1b-201 and day 0 of protocol fx1b-303, an abbreviated physical examination (including weight and vital signs) and clinical laboratory assessments must be performed on day 0. eligible patients will begin once-daily dosing with 20 mg fx-1006a at home on day 1 (i.e., first dose) and will return to the clinical unit for study visits every 6 months. adverse events (aes) and concomitant medication use will be collected at each 6-month visit to the clinical unit. blood draws for clinical safety laboratory tests and abbreviated physical examinations (including weight and vital signs) will also be performed at each 6-month clinic visit. ecgs will be performed every 12 months on an annual basis. a telephone call will be made at 3-month intervals between clinic visits to assess safety and use of concomitant medications. for the evaluation of efficacy, the patient global assessment, nyha classification, kccq, 6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin t, troponin i, and nt-pro-bnp) will be determined every 6 months. in addition, echocardiograms will be performed every 12 months on an annual basis. an end of study visit including all safety and efficacy assessments will occur upon patient completion of the study, premature withdrawal (for any reason), or in the event of program discontinuation by the sponsor.


Eligibility criteria:
inclusion criteria: * patient successfully completed protocol fx1b-201. * if female; patient is post menopausal. if male, female partner is post-menopausal. if female is of child bearing potential, willing to use acceptable method of birth control up to 3 months after last dose (included female partners of male participants). * patient is willing to comply with protocol. exclusion criteria: * patient did not successfully complete fx1b-201. * chronic use of nsaids. * patient has a clinically significant medication condition that increases risk of study participation. * patient has received heart or liver transplant.

Keywords: ttr, attr, cardiomyopathy, amyloidosis, tafamidis
use of intrapartum biophysical profile when fetal heart rate monitoring is non-reassuring in labor

Conditions: Fetal Distress

Summary: in this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.

when you are in labor, the heart beat of your fetus is monitored continuously. the normal pattern is reactive and suggests that the fetus is doing well. when the pattern is different from reactive, it is difficult to say if the fetus is doing well or not. previous investigators have shown that even with the most worrisome fetal heart rate pattern, only 2/1000 cases would require immediate delivery. currently, we use invasive procedures like taking a drop of blood from fetal head to further assess how the fetus is doing or just proceed with the fastest way of delivery (which could increase the risk associated with surgery). in this research project we want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.

Eligibility criteria:
inclusion criteria: * spontaneous or induced labor * gestational ages between 35 - 42 weeks * singleton pregnancy * intrapartum non-reassuring or uninterpretable fhr tracing defined as any tracing that the labor and delivery obstetrician is uncomfortable about or feels does not absolutely provide fetal reassurance. inclusive fhr patterns will be repetitive late decelerations, recurrent moderate to severe variable decelerations, reduced long or short-term variability, prolonged bradycardia (\ 160/min for \>60 min,) or any other fhr patterns necessitating further fetal well being evaluation (like scalp ph or scalp stimulation). exclusion criteria: * multiple gestation * gestational age \< 35 weeks * patient denial to undergo ultrasound examination during labor * abnormal fhr tracing requiring stat delivery

Keywords: non reassuring fetal heart rate tracing biophysical profile assessing fetal wellbeing
adhesive tape trauma evaluation of a new gentle tape in healthy infant subjects

Conditions: Skin (FLACC Scores of Test Subjects) After Tape Removal

Summary: the objective of this study is to determine the relative gentleness of a new medical tape.

the objective of this study is to determine the relative gentleness of a new medical tape. a three-prong multidimensional evaluation consisting of expert grader, subject discomfort assessment, and laboratory assessments was used. one pre-study visit took place up to 7 days prior to the start of the study. the study was conducted over two days with one tape sample applied and removed. assessments were taken on the final day. this was to mimic a normal tape application in health care practice.

Eligibility criteria:
inclusion criteria: subjects will be infants or children of either gender who meet the following criteria: 1. who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema 2. who are between the ages of 6 months - 4 years of age (48 months) 3. who have a fitzpatrick skin type of i, ii or iii 4. whose parent or legal representative agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date 5. whose parent or legal representative agrees to sponge bathe their child during the study but agrees to not bathe their child 1 hour before each visit. 6. whose parent or legal representative agrees to not soak the tape during a sponge bath. if the site gets wet, parent or legal representative agrees to pat their child's back dry (no rubbing). 7. whose parent or legal representative is willing to sign the informed consent form (with photo release) and hipaa authorization. exclusion criteria: 1. who are known to be developmentally delayed 2. who have any known allergy or sensitivity to tapes 3. who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test site 4. who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study 5. who have had a strep infection within the 2 weeks prior to the start of the study 6. who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions 7. has participated in any study in the last 2 weeks, or are currently participating in another study, or are scheduled to participate in another study during this study period. 8. has any other skin disorders that, in the opinion of the investigator, will interfere with the study results or will increase undue risk for the child.
liraglutide as additional treatment in patients with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: evaluating the use of liraglutide in patients with type 1 diabetes.

this investigation will be a retrospective chart review of in type 1 diabetics who have been treated with liraglutide. the study will be conducted at diabetes-endocrinology center of wny at millard fillmore hospital, affiliated to the state university of new york at buffalo. study population: 40 patients with type 1 diabetes on treatment with either continuous subcutaneous insulin infusion (csii; also known as insulin pump) or multiple (four or more) injections of insulin per day on continuous glucose monitoring system (cgms) will be included in the study. these patients with type 1 diabetes have been treated with liraglutide in addition to insulin. the investigators would retrospectively review their charts to evaluate decreases in fasting, postprandial and the overall mean glucose concentrations. the investigators will compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following one week and 12 weeks of treatment with liraglutide daily. in addition, the investigators will compare the time spent at glucose concentrations \>150 and 200mg/dl and \<70 and \<40 mg/dl. hba1c levels before and after 12 weeks of treatment with liraglutide daily will be compared.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus exclusion criteria: * type 2 diabetes mellitus