Kornimate/medical-research-clean huggingface dataset:
once - daily oral direct factor xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. the einstein-extension study

Conditions: Venous Thromboembolism

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. patients with confirmed symptomatic dvt (deep vein thrombosis) or pe (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or vka (vitamin k antagonist) are eligible for this trial (einstein-extension study).

within the us 'johnson \& johnson pharmaceutical research \& development, l.l.c.' is sponsor. the treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. participants who did not complete the treatment period also entered the observational period. it was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.

Eligibility criteria:
inclusion criteria: * patients with confirmed symptomatic pe or dvt who have been treated for 6 or 12 months with vka or rivaroxaban exclusion criteria: * legal lower age limitations (country specific) * indication for vka other than dvt and/or pe * patients in whom anticoagulant treatment for their index pe or dvt should be continued * childbearing potential without proper contraceptive measures, pregnancy or breast feeding. proper contraceptive measures are defined as a method of contraception with a failure rate \< 1 % during the course of the study (including the observational period). these methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (cpmp \[committee for proprietary medicinal products\]/ich \[international conference on harmonization\]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
multi parametric test predicting the risk of colorectal neoplasia recurrence

Conditions: Colon Cancer

Summary: this project is dedicated to identify the patients with possible higher risk of adenoma recurrence who should have follow-up colonoscopy in yearly interval. as a result, it can lead to optimizing the of follow-up colonoscopies intervals in real-world practice.

in this project, 200 individuals (aged 18 - 75 years) with removed colorectal polyps larger than 10 mm during colonoscopy performed based on all indication (including symptoms and screening procedures) will be included. all procedures will be done with high quality endoscopes (high definition, hd). in all polyps, the advanced imaging techniques (such as chromoendoscopy and nbi) will be used to determine parts of the polyp suspicious from high-grade dysplasia or cancer. the therapeutic method will be decided by the size and macroscopic appearance of the polyp. in case of flat, sessile polyps and lst lesions (laterally spreading tumors) emr or esd will be performed. pedunculated polyp will be removed by epe. the goal is to achieve the en-bloc resection. pathologists (with presence of the endoscopist) will do the first step of histopathology evaluation (cutting the polyp tissue). the aim is to perform the first cut in the most advanced part of the polyp and high density cutting in this area. standard histopathology evaluation will proceed and will be followed by initial basic molecular testing. subsequently, all patients will be observed by colonoscopy in one-year intervals with focus on polyp recurrence. the group of high-risk patients will be selected with at least one of these criteria: 1/ high grade dysplasia adenoma at index colonoscopy; 2/ high score of polyp heterogenity at index colonoscopy; 3/ polyps recurrence at follow-up colonoscopy. in a high-risk patients group the extensive somatic mutations profiling will be carried out according to multitarget sequencing by ngs technologies (next generation sequencing). same testing will be done in randomly selected patients not included in the high-risk group, which will be used as a control group for statistical evaluation.

Eligibility criteria:
inclusion criteria: * colorectal polyp larger than 10mm removed by colonoscopy therapeutic method (epe, emr, esd) * signed informed consent with the study and with colonoscopy exclusion criteria: * fap, hnpcc and other hereditary crc syndromes probands * recent diagnostic, follow-up or preventive colonoscopy (fobt-positive colonoscopy, screening colonoscopy) in ≤ 3 years * colonoscopy contraindication * severe acute inflammatory bowel disease * severe comorbidities; likely non-compliance of the patient

Keywords: colorectal neoplasia adenoma colonoscopy gene mutation follow-up recurrence multiparametric test
study to assess safety and tolerability of oral cc-115 for patients with advanced solid tumors, and hematologic malignancies.

Conditions: Glioblastoma Multiforme; Squamous Cell Carcinoma of Head and Neck; Prostate Cancer; Ewing's Osteosarcoma; Chronic Lymphocytic Leukemia; Neoplasm Metastasis

Summary: the main purpose of this first human study with cc-115 is to assess the safety and action of a new class of experimental drug (dual dna-pk and tor kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. the bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

latest amendment clarifies that chronic lymophocytic leukemia (cll) includes t-cell prolymphocytic leukemia (t-pll). prior treatment with some drugs targeting mtor, p13k and related pathways is now permitted.

Eligibility criteria:
inclusion criteria: * histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, t-cell prolymphocytic leukemia, non-hodgkin lymphoma or multiple myeloma * progressed or not tolerated standard therapy, and no further standard therapy is available * archival and screening tumor biopsy * eastern cooperative oncology group performance status: 0 or 1 * adequate organ function exclusion criteria: * prior cancer-directed modalities or investigational drugs within 4 wks or 5 half lives, whichever is shorter * symptomatic brain metastases (prior treatment and stable metastases are allowed) * acute or chronic renal disease or pancreatitis * diarrhea ≥ grade 2, impaired gastrointestinal absorption * impaired cardiac function * history of diabetes requiring treatment, glucose \>126 mg/dl, glycated hemoglobin (hba1c) ≥6.5% * peripheral neuropathy ≥ grade 2 * known human immunodeficiency virus (hiv) infection, chronic hepatitis b or c (unless associated with hepatocellular cancer) * pregnant, inadequate contraception, breast feeding * most concurrent second malignancies * part b only: prior treatment with agents targeting both mammalian target of rapamycin (mtor) complexes (dual mammalian target of rapamycin complex 1/2 inhibitors) and/or pi3k/akt pathways. however, prior treatment with isolated target of rapamycin complex 1 (torc1) inhibitors (eg., rapalogs) is allowed in both parts of this study.

Keywords: neoplasm malignancy carcinoma lymphoma leukemia multiple myeloma mtor kinase inhibitor castration-resistant prostate cancer hormone-resistant prostate cancer diffuse large b-cell lymphoma
comparison of systemic response after laparoscopies performed with standard and low-pressure pneumoperitoneum

Conditions: Laparoscopy.

Summary: the purpose of the study was the comparative assessment of the influence of low and standard pressure co2 pneumoperitoneum on the systemic inflammatory and angiogenic responses during the postoperative period after laparoscopic management of cholelithiasis.

objective: the purpose of the study was to access the influence of low pressure co2 pneumoperitoneum on the inflammatory and angiogenic responses during the postoperative period after laparoscopy. summary background data: surgical procedures enhance production of pro- and anti-inflammatory cytokines and angiogenic factors that play a pivotal role in the immunological response to surgical trauma and take part in the pathogenesis of tumor growth and adhesions formation. methods: study group consisted of 40 patients, operated on due to cholelithiasis using standard- (n=20) and low-pressure (n=20) co2 pneumoperitoneum. serum concentration of il-6, il-8, il-10, vegf-a and endostatin were measured before the surgeries and thereafter at 6, 24 and 48h with commercially available elisa assays. results: concentrations of il-6 increased significantly after the operations in both groups. no differences were observed between the groups in regards to il-6, il-8 and il-10 levels. concentrations of vegf-a measured at 6 and 48h were significantly lower in patients who underwent laparoscopies performed with low pressure pneumoperitoneum. no significant variations were observed in endostatin serum concentration. concentrations of the studied parameters were not influenced by the duration of surgeries, age, gender, or bmi of the patients. conclusions: the results obtained in our study do not show any significant differences between studied operative procedures with regards to systemic inflammatory response. changes in the concentrations of vegf-a and endostatin observed in the studied population may suggest this technique to be more favorable with regards to angiogenesis process intensity, along with all its consequences and implications.

Eligibility criteria:
inclusion criteria: * cholelithiasis exclusion criteria: * symptoms of acute cholecystitis, diabetes, body mass indx above 36 kg/m2 and autoimmunological diseases.

Keywords: low-pressure pneumoperitoneum laparoscopy cytokines vegf-a endostatin
phase4/symbicort® versus pulmicort flexhaler® in african americans

Conditions: Asthma

Summary: to compare the efficacy of symbicort® pmdi 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder dpi 180 μg x 2 inhalations bid, in african american(self-reported) subjects with inhaled corticosteroid (ics) dependent asthma.


Eligibility criteria:
inclusion criteria: * african american (self-reported) * documented clinical diagnosis of asthma as defined by the american thoracic society (ats) for at least 6 months prior to visit 2 and be in stable condition. * fev1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after laba, of 45%-85%, inclusive, of predicted normal. exclusion criteria: * has been hospitalized at least once for an asthma related condition during the 6 months prior to visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to visit 2. * has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to visit 2. * has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of visit 3 that, in the investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry

Keywords: asthma
testing of dna extracted from tumor tissue biopsy samples using therascreen kras rgq pcr kit

Conditions: Non Small Cell Lung Cancer

Summary: a non-interventional biomarker study for the testing of dna extracted from tumour tissue biopsy samples, using the therascreen® kras rgq pcr kit, from patients with non-small cell lung cancer, screened in clinical study (protocol no. 20190294).

this is a non-interventional, biomarker screening clinical performance study protocol, for the testing of dna extracted from tumour tissue biopsy samples (resected and core needle biopsy \[cnb\]/fine needle aspiration \[fna\] tumour tissue) obtained from patients with non-small cell lung cancer (nsclc), using the kras kit. a formal hypothesis will not be tested in this study. up to 7000 patient tissue samples (from approximately 5000 patients at 500 clinical trial sites), obtained in the clinical study (protocol no. 20190294), will be tested using the kras kit. the testing will be performed at the investigational device clinical testing sites, q2 solutions laboratories in the four geographical locations: usa, singapore, uk and china

Eligibility criteria:
inclusion criteria: * all patients who provided consent (by signing and dating the icf for protocol no. 20190294), may be included in the clinical performance study. exclusion criteria: * patients whose tumour tissue biopsy samples that are not clinical study assay evaluable * patients with samples identified for the study which have insufficient testing material * specimens which have undergone decalcification.
measuring the impact of an interdisciplinary polypharmacy clinic within a patient-centered medical home

Conditions: Polypharmacy

Summary: title: measuring the impact of an interdisciplinary polypharmacy clinic within a patient-centered medical home objectives: the primary objective of this project will be to track the types of interventions made in an interdisciplinary polypharmacy clinic to improve medication regimens and medication burden. polypharmacy has been well documented in the literature as a risk for medication errors, adverse drug events, and morbidity. team visits, including complete medication reviews, by pharmacists and physicians within a national committee for quality assurance (ncqa) tier 3 patient-centered medical home (pcmh) at an academic medical center, can improve medication regimens. secondary objectives include (1) measuring each patient's quality of life at baseline and one month post-intervention and (2) tracking the cost of medication additions and discontinuations. methods: patients taking ten or more chronic medications will be identified for referral to the polypharmacy clinic from a report generated from the electronic medical record. the polypharmacy clinic will be staffed by a pharmacist and medical resident with oversight from an attending physician who specializes in geriatrics. drug-related problems identified during the visit will be resolved and categorized based upon indication, efficacy, cost, safety, and compliance. the numbers and types of interventions made, both during the primary visit and anticipated in the future, will be tracked. the 12-item short form (sf-12) survey will also be administered at baseline and one month post intervention. the increase or decrease in cost for medications added and removed during these visits will be captured using the average wholesale prices. preliminary results using descriptive statistics, the types of drug-related problems identified and interventions made will be reported. changes in quality of life and monthly medication costs will also be described.


Eligibility criteria:
inclusion criteria: * patients on 10 or more chronic medications * age 18 or older exclusion criteria: * non-english speaking patients

Keywords: drug related problems comprehensive medication review quality of life
the standard management of hpv infection

Conditions: the High-Risk HPV Infection

Summary: high-risk human papillomavirus (hr-hpv) infection is a necessary condition in the occurence and development of cervical squamous intraepithelial lesion (sil) and cervical cancer. there are cases that high-grade sil (hsil) and stage ia1 cervical squamous cancer remain or reoccur, or even become more severe after conization. the infection situation of hr-hpv, which plays an important role in the prognosis of cervical lesion, should be consulted in the management and follw-up after conization. it is worthwhile making further study in the specific practical significance of the hr-hpv in the prognosis of cervical lesion, as well as the high-risk factors that influence the prognosis of hr-hpv.

main purpose:to work out the standard management of hpv infection by following up the hpv infection situation of the patients with high-grade sil (hsil) and stage ia1 cervical squamous cancer after conization. research design:first, to do the retrospective analysis toward the patients who received conization between jan 2009 to aug 2016.second,to do the prospective analysis toward the patients who received conization between spt 2016 to aug 2018. inclusive criteria of study population:the patients who had finished hpv genotype testing before conization;who had never received treatment other than conization;who were histologically diagnosed as hsil or ia1 cervical squamous cancer;who had not been diagnosed as any cervical diseases before;who were under age 70;who did not have any severe diseases that influence the follow-up. follow-up methods:to do the follow-up to the target patients by 3,6,9,12,18,24 months after conization. follow-up contents:the hr-hpv genotype infection before conization;the grade of lesion;the age when received conization;the gravity and parity;the situation of the glands invovement

Eligibility criteria:
inclusion criteria: * age not above 70 * histologically diagnosed as hsil or stage ia1 cervical squamous cancer * received conization in beijing obstetrics and gynecology hospital * hr-hpv infected without any treatment other than conization * hr-hpv genotype tested before coniztion exclusion criteria: * age above 70 * with severe desease that influence the follow-up * received other treatment on cervical lesion * data incompleted * not meet the inclusive criteria
a study testing a radioactive compound given through a vein with and without the non-radioactive compound, given by mouth, to characterize tissue distribution using positron emission tomography scanning

Conditions: Healthy

Summary: in this study, radioactive pf-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive pf-06427878 to healthy, adult, male subjects. positron emission tomography will be used to characterize tissue distribution. the study will also characterize how the study drug behaves in the body, its safety, and how the body tolerates it.


Eligibility criteria:
inclusion criteria: * healthy males * body mass index 17.5-30.5 kg/m2 ; body weight \>50 kg * signed and dated informed consent document * willing and able to comply with study requirements exclusion criteria: * tobacco/nicotine containing products \> equivalent of 5 cigarettes per day * history of cumulative ionizing radiation exposure in the past year, including anticipated exposure in this study, and subjects with current, past or anticipated exposure to radiation in the workplace * severe claustrophobia * unable to lie still for the required period to acquire images

Keywords: hyperlipidemia positron emission tomography
efficacy of balanced nutrition meal replacement along with a caloric restriction on body weight control

Conditions: Obesity; Diet Modification; Nutrient; Excess

Summary: the present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet with caloric restriction (intervention for 8 weeks) in taiwanese obese subjects. various parameters like anthropometric (body weight, body fat, waist circumference), lipid profile (tc, ldl-c and tg), cardiovascular risk factors, glycemic and oxidative markers as well as renal and hepatic markers were evaluated.

the present study was designed to evaluate the impact of a nutritionally balanced conventional meal replacement diet (rich in soy/pea protein and soluble fibers) with caloric restriction in taiwanese obese subjects. obese subjects (bmi\>27; n=50, male 23, female 27) were recruited and requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.

Eligibility criteria:
inclusion criteria: * healthy obese subject (bmi \>27) * aged between 20 to 80 of both genders with a desire to lose weight. exclusion criteria: * subjects with cancer * hyperglycemic (diabetic) * hypertension, * stroke * renal dysfunction * cardiac or hepatic dysfunctio * allergic to the dairy product and eating disorders * pregnancy, nursing (lactating), chain smokers and heavy alcoholic subjects

Keywords: meal replacement calorie restriction body weight
incidence of acute kidney injury and risk factors in newborns with congenital diaphragmatic hernia

Conditions: Congenital Diaphragmatic Hernia; Acute Kidney Injury; Multiple Organ Failure; Pulmonary Hypertension; Hyperchloremia

Summary: the main aim of this project is to elucidate the incidence of acute kidney injury (aki) in newborns with congenital diaphragmatic hernia during stay in the pediatric intensive care unit. (picu). this patient group often presents with severe circulatory and respiratory dysfunction requiring intensive care treatment. characterization of risk factors to aki will also be performed.

there is an overwhelming number of studies showing that complication with acute kidney injury (aki) in critically ill patients, including children and newborns results in increased morbidity and mortality. the more severe aki, the higher risk of bad outcome. in the neonatal intensive care unit (nicu), the incidence of aki is approximately 30 %, even higher in full-term babies (36 %). newborns with congenital diaphragmatic hernia (cdh) often present with severe cardio-respiratory dysfunction, often complicated by pulmonary hypertension (pphn) requiring mechanical ventilation and vasoactive/inotropic drugs, especially during the first week in the intensive care. some of these patients deteriorates and cannot maintain vital parameters despite conventional treatment and will therefore require extra corporeal membrane oxygenation). during the icu-stay, the patients are subjected to several risk factors for developing aki. among physiological risk factors, pphn, low oxygenation and blood pressure may result in renal dysfunction. iatrogenic factors include the need for nephrotoxic drugs, not least antibiotics (vancomycin, gentamycin) and antimycotics. in addition, hyperchloremia may contribute to the development of aki, since impaired renal blood flow is associated with hyperchloremia. the aki incidence and its risk factors in cdh patients is not well studied. the objectives of this well characterized retrospective cohort study is to establish aki incidence in critically ill cdh-patients and investigate possible associations between risk factors and aki (exposure to nephrotoxic drugs, degree of multiple organ failure, pphn, vasoactive/inotropic requirement, oxygenation index, fluid overload and hyperchloremia) during picu stay. the association of the risk factors to different stages of aki will also be investigated.

Eligibility criteria:
inclusion criteria: newborns with congenital diaphragmatic hernia intubated and started invasive ventilation within 2 days. - exclusion criteria: * invasive ventilation initiated after 2 days. * severe comorbidity not compatible with life and/or not possible to correct surgically. * death occurring within 2 days.

Keywords: congenital diaphragmatic hernia acute kidney injury