Kornimate/medical-research-clean huggingface dataset:
autologous tumor tissue antigen-sensitized dc-cik cells combined with chemotherapy for esophageal cancer

Conditions: Esophageal Neoplasms; Neoplasms; Digestive System Neoplasms; Esophageal Cancer

Summary: this study evaluates the safety and efficacy of d-cik immune cells combined with chemotherapy after resection of esophageal cancer

60 patients of esophageal cancer with tnm stage of tumor stage ii-iii,who had received surgery and kept their tumor tissue, will be randomly divided into group a (receive cancer tissue antigen sensitized d-cik immune cells in combination with chemotherapy treatment) or group b (just receive chemotherapy), and the randomize ratio will be 1:1. patients in group a will receive 3 cycles of autologous antigen-sensitized dc-cik cells treatment (every 4 weeks) and chemotherapy. patients in group b will receive only 3 cycles chemotherapy.

Eligibility criteria:
inclusion criteria: * 18-75 years old; * clinical diagnosis of esophageal cancer patients,tumor tnm stageii-iii; * patients who can accept curative operations; * patients who have a life expectancy of at least 3 months; .eastern cooperative oncology group (ecog) performance status was 0-2. exclusion criteria: * white blood cell \<3 x 10\^9/l,platelet count \<75 x 10\^9/l;bun and cr more than normal limits on 3.0 times ; * known or suspected allergy to the investigational agent or any agent given in association with this trial; * pregnant or lactating patients; * known history of human immunodeficiency virus (hiv), hepatitis c virus (hcv) or treponemapallidun (tp) infection; * patients who are suffering from serious autoimmune disease; * patients who had used long time or are using immunosuppressant; * patients who had active infection; * prior use of any anti-cancer treatment in 30 days; * now or recently will join another experimental clinical study ; * history of organ allograft; * other situations that the researchers considered unsuitable for this study
multiple-center retrospective study of severe and critical covid-19 in shanghai

Conditions: COVID-19

Summary: this study is to clarify the clinical characteristics of severe and critical covid-19 from march 1st ,2022 to june 9th, 2022 in shanghai and to explore the relationship between the characteristics and prognosis in these patients.

1. to describe the clinical characteristics of severe and critical covid-19. 2. to analyze the relationship between the clinical characteristics and their clinical prognosis; 3. to analyze the relationship between clinical intervention and their clinical prognosis.

Eligibility criteria:
inclusion criteria: * severe and critical covid-19 patients who met the "diagnosis and treatment plan for new coronavirus pneumonia (ninth edition)" * admission time more than 24 hours exclusion criteria: * admission time less than 24 hours
etiology, epidemiology and prognostics of aki

Conditions: Acute Kidney Injury

Summary: * to investigate the etiology and epidemiology of acute kidney injury (aki). * to find out risk factors associated with the occurence of aki. * to find out risk factors related to the prognosis of aki,focusing on uremic toxins, inflammation, oxidative stress and nutritional status. * to study on the relationship between gene polymorphism and prognosis of acute kidney injury.

1. to investigate the relationship between preexisting protein-energy wasting (pew) and adverse outcomes in patients with aki. 2. to evaluate the association of serum nutritional variables and prognosis of aki. 3. given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (\ 7 days, \<28 days) patients. 4. to investigate the various kinds of uremic toxins in aki, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in aki patients. 5. to investigate the mineral bone disorders in aki,and to evaluate whether these markers would role as prognostic predictors of aki. 6. several risk factors of mortality in aki,such as markers of pew, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a "gold standard."

Eligibility criteria:
inclusion criteria: * age \>=18 years and \<= 88 years * clinically diagnosed with acute kidney injury, according kdigo criteria. exclusion criteria: * preexisting chronic kidney failure (defined as an egfr \<60 ml/min per 1.73 m2) * post-renal obstruction or rapid progressive glomerulonephritis as the main cause of aki * known acute renal dysfunction * hospital stays \<24 hours * malignancy

Keywords: acute kidney injury proteinosis epidemiology risk factors
b181 metobes-iii: weight loss maintenance of a new bioactive compound (metobes-long)

Conditions: Obesity

Summary: to investigate the 5-hour acute effect on energy expenditure, substrate oxidation and ad libitum food intake after intake of the metobes-compound (green tea extract, capsaicin, tyrosine, caffeine). furthermore, to investigate if the effect of the metobes-compound can be inhibited by blocking the β-adrenergic receptors. the effect of the metobes-compound will be investigated by: 1. 5-hour energy expenditure and respiratory quotient (ventilated hood). 2. 5-h change in blood pressure and heart rate 3. 5-h change in sympathetic/parasympathetic ratio. 4. ad libitum energy intake. 5. self-reported postprandiel appetite sensations (vas).

subjects 22 healthy danish overweight to obese men (bmi between 25 and 35 kg/m2), 18 to 50 years of age. all subjects must be weight stable (within  3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication. method the study is designed as a 4-way crossover, randomised, placebo controlled, double-blind study. each treatment will be separated by \>1-week washout period. the treatments will consist of: 1. bioactive metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 5 mg propranolol. 2. bioactive metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with 10 mg propranolol. 3. bioactive metobes compound (green tea extract, tyrosine, caffeine and capsaicin) without calcium together with a placebo tablet for propranolol (microcrystalline cellulose). 4. placebo for the metobes compound (microcrystalline cellulose) together with a placebo tablet for propranolol (microcrystalline cellulose). on each test day body weight and composition will be assessed. all subjects will undergo a 5-h post dose assessment of energy expenditure by indirect calorimetry in a ventilated hood. subjective appetite sensations, ecg and dual measures of blood pressure/heart rate will be assessed every 30 minutes. after completed respiratory measurements the subjects will be served an ad libitum lunch meal (pasta salad). all subjects shall collect all urine excreted during the respiratory measurements. urine samples will be analyzed for nitrogen content and content of catecholamines.

Eligibility criteria:
inclusion criteria: * 21 healthy danish normal-weight to obese men (bmi between 20 and 35 kg/m2), 18 to 50 years of age. all subjects must be weight stable (within  3-kg) 2 months prior to study inclusion, non-smoking, non-athletic and have no daily use of medication. exclusion criteria: * they will be excluded if they do not meet the inclusion criteria and/or the blood pressure is above 165/95 mmhg and/or the ecg is abnormal.

Keywords: green tea capsaicin tyrosine caffeine energy expenditure catecholamines
characterization, risk factors and outcome of neonates admitted to neonatal intensive care units (nicu) at sohag university hospitals

Conditions: Neonatal Diseases

Summary: the neonatal period considered the time from birth up to the first 28 days of life \& further classified into: * very early birth (birth to \< 24 hours). * early birth (24 hours to \< 7 days). * late or last neonatal period (7 days to 28 days). it is characterized by the transition from extra uterine life and rapid growth and development. it is the common vulnerable time or period of human life as it accounts for more high mortalities and morbidities, however, most of them are preventable. the pattern of neonatal disease is a useful indicator of the availability, utilization and effectiveness of maternal and child health care services. it varies from place to place and from time to time even in the same locality. information on admission and mortality patterns of hospitalized neonates should reflect the major causes of illnesses and standard of care provided to neonates in a particular locality. to improve neonatal services with better overall outcomes and less sever morbidities early identification of the risk factors is paramount so that appropriate interventions can be directed towards the most prevalent and treatable neonatal illnesses. to achieve this goal, it is important to study the pattern of neonatal admissions


Eligibility criteria:
inclusion criteria: * all neonates that will be admitted in neonatal intensive care units (nicu) including preterm, term and post term neonates. exclusion criteria: * failure to obtain consent. * neonates need preparation for advanced interventions not available in our unit like cardiac operations. * neonates require peritoneal dialysis. * traumatic injury.
coa-z in pantothenate kinase-associated neurodegeneration (pkan)

Conditions: Pantothenate Kinase-Associated Neurodegeneration

Summary: the purpose of this study is to learn more about how people with the condition pantothenate kinase-associated neurodegeneration (pkan) respond to a specialized study product. we are hoping to find out if the study product is safe, what effects-good and bad-the study product causes, and whether the study product changes certain measures of disease in pkan.


Eligibility criteria:
inclusion criteria: * has a diagnosis of pkan confirmed by: a) genetic testing confirming 2 pathogenic or likely pathogenic mutations, or (b) typical findings on exam and brain mr imaging with only one pathogenic mutation +/- a second likely pathogenic or vous in pank2, or (c) typical findings on exam and brain mr imaging with a single likely pathogenic or vous in pank2, or (d) be a symptomatic sibling of a proband subject meeting a, b or c. * be between 3 months old and 89 years old. * be able to take study product by mouth or feeding tube. * be willing and able to complete study procedures / telephone visits / blood draws independently, or have a caregiver / parent willing and able to assist with these tasks. * be enrolled or willing to enroll in the pkanready natural history study (eirb 10832). * be resident in north america (us or canada) for the duration of the trial. exclusion criteria: * have had exposure to a putative pank2 bypass therapeutic agent in the 30 days prior to screening. * be concurrently enrolled in another interventional clinical trial. * have concurrent medical or other condition expected to preclude completion of study procedures of confound the assessment of clinical and laboratory measures of safety.

Keywords: neurodegeneration with brain iron accumulation nbia pkan
hypocholesterolemic effect of fibracep

Conditions: Hypercholesterolemia

Summary: fibracep is an onion based fiber that has demonstrated in vitro and in animal models the capacity to increase hdl cholesterol levels as well to improve other lipid profile species. this intervention aims to demonstrate fibracep's blood lipid profile improvement effect. for that purpose, hypercholesterolemic subjects will be recruited and given a daily dose of 7 g of fibracep for two months. changes in blood lipid profile will be the end-point of the study.


Eligibility criteria:
inclusion criteria: * total cholesterol levels above 200 mg/dl, observed in at least 3 different days * body mass index between 25 and 35 (overweight and obesity type 1 diagnosis) exclusion criteria: * type 1 and type 2 diabetes * allergy to any compound described in fibracep

Keywords: fiber cholesterol
efficacy and safety of adalimumab and methotrexate (mtx) versus mtx monotherapy in subjects with early rheumatoid arthritis

Conditions: Early Rheumatoid Arthritis

Summary: the purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (ra), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

this study had an initial 2-year double-blind treatment period followed by an 8-year open-label extension period, for a total of up to 10 years study duration. the study was designed to assess the potential of adalimumab + methotrexate to improve signs and symptoms of disease and to inhibit radiographic progression in patients with recent onset (disease duration less than 3 years) rheumatoid arthritis not previously treated with methotrexate. adalimumab is a human anti-tumor necrosis factor (tnf) monoclonal antibody.

Eligibility criteria:
inclusion criteria: * subject was age 18 or older and in good health (investigator discretion) with a recent stable medical history. * diagnosis of rheumatoid arthritis (ra) as defined by the 1987-revised american college of rheumatology (acr) criteria, with a disease duration less than 3 years, at least 8 swollen joints out of the 66 joints assessed, at least 10 tender joints out of the 68 joints assessed, at least 1 joint erosion or rheumatoid factor (rf) positivity, erythrocyte sedimentation rate (esr) \>= 28 mm/1h or c-reactive protein (crp) \>= 1.5 mg/dl exclusion criteria: * chronic arthritis diagnosed before the age of 16 * preceding treatment with mtx, cyclophosphamide, cyclosporin, azathioprine or more than 2 other disease-modifying anti-rheumatic drugs (dmards) * subject previously received anti-tumor necrosis factor (tnf) therapy * permanently wheelchair-bound or bedridden patients * subject considered by the investigator, for any reason, to be an unsuitable candidate for the study * female subject who is pregnant or breast-feeding or considering becoming pregnant

Keywords: early rheumatoid arthritis
osteopathic approach into neonatology ward: the ne-o model

Conditions: The Focus of the Study is to Provide a Guideline on Osteopathic Approach in Treating Hospitalized Newborns.

Summary: background several studies have shown the effect of osteopathic manipulative treatment on neonatal care in reducing length of stay, gastrointestinal problems, clubfoot complications and improving cranial asymmetry of infants affected by plagiocephaly. despite several results obtained, there is still lack of standardized osteopathic evaluation and treatment procedures for newborns recovered in neonatal intensive care unit (nicu). the aim of this research is to provide a guideline on osteopathic approach in treating hospitalized newborns. specific evaluation tests and treatments have been developed to tailor osteopathic method according to preterm and term infants' needs, nicu environment, medical and paramedical assistance.


Eligibility criteria:
inclusion criteria: * newborn admitted to neonatal intensive care unit * informed consent signed from parent or legal guardian exclusion criteria: * post surgery patients

Keywords: osteopathic manipulative treatment newborns preterm infants procedures
real-world evaluation of bezlotoxumab for the management of clostridioides difficile infection

Conditions: Clostridium Difficile Infection; Clostridium Difficile Infection Recurrence

Summary: this is a retrospective case:control study examining the use of adjunctive bezlotoxumab to standard c. difficile infection (cdi) treatment compared to standard cdi treatment alone in patients with cdi seen in an academic medical center's specialty outpatient clinic.

this specialty clinic is a unique practice setting where patients with ≥1 recurrent cdi and/or refractory disease are referred. the study will represent real-world data on the clinical use of bezlotoxumab as adjunctive therapy in combination with vancomycin or fidaxomicin for the treatment of patients with recurrent cdi. retrospective chart review will be conducted for patients who visited the specialty cdi clinic between 1/1/2005 through 12/5/2019. case patients will be defined as patients who have received bezlotoxumab 10 mg/kg intravenously in addition to standard cdi treatment. controls will be defined as patients who have received only standard cdi treatment and will be enrolled in a 2:1 ratio to cases. the primary outcome is recurrence of cdi. recurrence is defined as a new episode of c. difficile infection that occurs after the initial clinical cure of the baseline episode within 12 weeks of receipt of bezlotoxumab or standard cdi treatment. clinical cure is defined as no diarrhea for 2 consecutive days after completion of standard-of-care cdi therapy. recurrent cdi will be diagnosed via clinical signs and symptoms and cdi diagnostic assay.

Eligibility criteria:
inclusion criteria (cases): * age 18 years and older * diagnosis of c. difficile infection by clinical signs and symptoms and/or c. difficile diagnostic assay * received bezlotoxumab in addition to standard cdi treatment inclusion criteria (controls): * age 18 years and older * diagnosis of c. difficile infection by clinical signs and symptoms and/or c. difficile diagnostic assay * received only standard cdi treatment exclusion criteria: * diarrhea due to causes other than c. difficile * incomplete documentation in the electronic medical record
decision aid (da) for renal patients

Conditions: Kidney Tumor; Renal Cancer

Summary: the objective of this study is to understand how patients make decisions about treating their kidney masses, and to identify key values and preferences for treating their kidney masses. the study team will develop a decision aid (da) using the decision-analytic model to communicate personalized benefit/harm estimates to patients and promote patient-centered treatment of renal tumors.


Eligibility criteria:
inclusion criteria: * male and female post-op and pre-op patients, ages 18 and older, diagnosed with a localized renal tumor up to 4 cm in diameter. * patients scheduled for standard-of-care clinical exams with the nyu urology department exclusion criteria: * stage iv cancer of any type * inability to provide informed consent * vulnerable subjects will not be recruited
remote monitoring of patients with chf in central greece

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. in addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

the purpose of this study is to the evaluate the use of a mobile and pstn phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. following this; it is also hypothesized that this will also lead to a change in overall risk for chf complications. in addition the patients' satisfaction using the telemedicine service will be studied. a cost-effective analysis and cost utility analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years. * discharge from hospital after acute heart failure in the previous 3 months and fe \ 40% plus bnp \> 400 (or plus nt-probnp\>1500) during hospitalization exclusion criteria: * comorbidities prevalent on chf with life expectation \< 12 months. * inability to use the equipment and help at home not available. * myocardial infarction or percutaneous coronary intervention in the last 3 months. * coronary artery bypass, valve substitution or correction in the last 6 months or scheduled. * being on waiting list for heart transplantation. * being enrolled in other trial.

Keywords: congestive heart failure telemedicine
distal radius fracture - treatment comparison

Conditions: Minimally Displaced Intra-articular Distal Radius Fracture

Summary: this is a prospective multi-site study. subjects with distal radius fractures will be enrolled. subjects will be treated surgically with a sonoma wrx™ device or managed non-operatively with a splint or cast. subjects will be enrolled in each group according to physician's standard of care (either casting/splinting or surgery) for distal radius fractures. subjects will be enrolled based on the study's inclusion/exclusion criteria with a final qualifying decision made by a group of three independent adjudicators. the final qualifying review should allow for similar patient groups within each arm of the study due to the variability that can arise in fracture classification. review by the adjudicators should be completed within 1 week.


Eligibility criteria:
inclusion criteria: * closed extra-articular distal radius fracture or a minimally displaced intra-articular fracture * fracture classified as an ao/ota a2, a3, c1 or c2 with or without an ulnar styloid fracture * must be treated within the first 14 days of injury, * male or female greater than or equal to 65 years of age. * able to understand the requirements of the study, provide a written informed consent and comply with the study protocol * ability to understand and provide written authorization for use and disclosure of personal health information * fracture that can be treated closed with or without closed reduction exclusion criteria: * concomitant contralateral or ipsilateral upper extremity fractures * ipsilateral ulna (excluding styloid) fracture * open fracture * previous ipsilateral distal radius fracture in the 2 years prior to enrollment with deformity * unstable distal radioulnar joint after fracture fixation * fractures where the transverse fracture line is less than 10mm from the distal radius joint surface * artery or nerve injury secondary to fracture * history of alcoholism * currently on chemotherapy or radiation therapy * currently on worker's compensation * rheumatoid arthritis or other inflammatory arthropathies. * history of chronic pain issues or psychiatric disorder that precludes reliable follow-up.
alogliptin tablets special drug use surveillance: mild type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

this is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting. participants will be patients with mild type 2 diabetes mellitus. the planned sample size is 20,000. the usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.

Eligibility criteria:
inclusion criteria: -patients with haemoglobin a1c (hba1c) \[japan diabetes society (jds) value\] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication. exclusion criteria: -patients contraindicated for alogliptin. 1. patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus. 2. patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury. 3. patients with a history of hypersensitivity to any ingredient of alogliptin.