Kornimate/medical-research-clean huggingface dataset:
intravenous dnase i for the treatment of sepsis (idealsepsisi)

Conditions: Sepsis; Critical Illness

Summary: phase i dose-escalation safety and feasibility of iv dnase i in icu septic patients.

in sepsis, the release of 'neutrophil extracellular traps' (nets) by activated neutrophils may contribute to organ damage by acting as scaffolds that trap blood cells and fibrin clots. excessive net formation can occlude the vasculature, promoting thrombosis and tissue hypoperfusion. this is a trial on a novel iv therapy for septic patients that shows promise in multiple animal models of sepsis. the therapy, dnase i, is an enzyme that helps to dismantle nets by digesting cell-free dna (cfdna), the major structural component of nets. the objective of this study is to conduct a phase i dose-escalation safety and feasibility of iv dnase i in icu septic patients. the results of this study may justify a future phase ii trial of the efficacy and safety of dnase i for critically ill patients with sepsis. this trial proposes 1. - to determine the safety, feasibility and maximum tolerated dose (mtd) of using dnase i in septic patients 2. - to evaluate clinical endpoints common in the critically ill such as organ dysfunction severity and trajectory, icu length of stay, and mortality. 3. - to describe the effects of dnase i on blood coagulation and nets release 4. - to collect samples for future studies on coagulation and immune function in sepsis.

Eligibility criteria:
inclusion criteria: 1. age of ≥18 years 2. admitted to the icu in the last 48 hours 3. suspected or proven infection as the admitting diagnosis 4. a sequential (sepsis) organ function assessment (sofa) score of ≥2 above baseline 5. expected to remain in the icu for ≥ 72 hours exclusion criteria: 1. no consent/inability to obtain consent from a substitute decision-maker 2. have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock 3. have a significant risk of bleeding as evidenced by one of the following: * surgery requiring general or spinal anesthesia within 24 hours before enrolment * the potential need for surgery in the next 24 hours * evidence of active bleeding * a history of severe head trauma requiring hospitalization * intracranial surgery, or stroke within three months before the study * any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system * a history of congenital bleeding diatheses * gastrointestinal bleeding within five weeks before the study unless corrective surgery had been performed * trauma is considered to increase the risk of bleeding * presence of an epidural catheter * need for therapeutic anticoagulation 4. receiving dnase i by inhalation 5. terminal illness with a life expectancy of fewer than three months 6. pregnant and/or breastfeeding
a study to investigate two 3-dose schedules of a clostridium difficile vaccine in healthy adults aged 65 to 85 years

Conditions: Clostridium Difficile Associated Disease

Summary: this study will investigate a clostridium difficile vaccine in healthy adults aged 65-85 years. each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. the study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. one year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. subjects will be followed for up to 4 years after their third vaccination.


Eligibility criteria:
inclusion criteria: * healthy male and female subjects * aged 65 to 85 years additional inclusion criteria for the extension stage: * receipt of all 3 doses of c difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study. exclusion criteria: * proven or suspected prior episode of clostridium difficile associated diarrhea * unstable chronic medical condition * disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine * serious chronic disorders * congenital or acquired immunodeficiency disorders * rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications. * active or treated leukemia or lymphoma or bone marrow disorder * any contraindication to vaccination or vaccine components including previous anaphylactic reaction to any vaccine or vaccine-related components additional exclusion criteria for the extension stage: * subjects originally randomized to placebo during the original portion of the study. * subjects who have already completed visit 9 prior to study unblinding.

Keywords: clostridium difficile, vaccine.
the health effects of a blueberry enriched diet on obese children

Conditions: Obesity

Summary: the purpose of this study to determine if adding blueberries to obese children's diet will improve weight status and other medical testing. we would also like to determine if a larger research study involving blueberries is possible.

ten children aged 12 to 17 years of age who have a bmi \> 95th percentile for age and who are patients of the center for better health and nutrition will be recruited for this 12 week study. group 1 (standard therapy): participants will be asked not to consume berries during the study so as not to confound the effects of eating blueberries. they will, however, be encouraged to consume other fruits consistent with nutrition guidelines for the healthy eating plan (hep: reduced glycemic load diet). participants will be instructed and receive educational handout materials on implementing hep. in addition participants will be introduced to the use of behavioral tools (e.g. goal setting, daily tracking when goals are met, and incentives provided by the family) to help them stay on track with hep. participants will be seen by the dietitian at monthly intervals consistent with programmatic standard of care to review adherence to hep, use of behavioral tools, and change in weight status. participants will be encouraged to attend group exercise classes five days per week or a minimum of four days per week. at the end of each exercise session, participants will receive a "sham smoothie" which contains no blueberries. the children will be directly observed by a study worker when consuming the smoothies to ensure compliance and measure how much of the smoothie was consumed. group 2 (blueberry enhanced): all the features of group 1 with the exception that the participants will be given a smoothie that contain 1 1/2 cups of freeze-dried whole blueberries crushed into a powder per serving.

Eligibility criteria:
inclusion criteria: * children 12 to 17 years old at the time of enrollment * children with a bmi ≥ 95th percentile for age * children participating in a weight management program at the cbhn. exclusion criteria: * children/parents/guardians who appear unable to understand the study * children/parents appear unable to meet the requirements of participating, specifically not missing more than 1 consecutive week during the 12 week intervention * children who have a medical condition or development impairment that precludes them from participating in an exercise program * children who have type 2 diabetes * children who have been diagnosed with hypertension * children who are taking a statin * children who are pregnant or have given birth within 6 months * children with a history of significant cardiac disease leading to cardiovascular instability * children who have food allergies or are lactose intolerant * children who are unable to finish at least half of the smoothie while they taste it after the consent/assent process or decide after tasting the smoothie that they are no longer interested in participating.

Keywords: obesity exercise blueberry plant
thiazide diuretics for hypertension in kidney transplant recipients using tacrolimus

Conditions: Hypertension; Kidney Transplantation

Summary: background: calcineurin inhibitors (cnis) are the most commonly used immunosuppressive drugs to prevent rejection after kidney transplantation. however, the efficacy of preventing rejection comes at the cost of important side-effects. among the most common side-effects is hypertension. hypertension after kidney transplantation is clinically relevant, because it increases the risk of cardiovascular disease and is associated with increased graft loss and recipient mortality. the mechanism of cni-induced hypertension is incompletely understood and, therefore, the treatment is currently empiric. these and other investigators recently showed that cnis cause salt-sensitive hypertension by activating a sodium transporter in the kidney, namely the thiazide-sensitive sodium chloride cotransporter. hypothesis: the investigators hypothesize that thiazide diuretics are non-inferior to calcium channel blockers (ccbs) (currently usually the treatment of choice) for the treatment of cni-induced hypertension. objective: to compare the blood pressure response to thiazide diuretics and ccbs in patients with cni-induced hypertension. study design: single-center, randomized cross-over trial. study population: kidney transplant recipients with a good functioning allograft (egfr \> 30 ml/min) who are hypertensive (daytime systolic blood pressure \> 140 mm hg) and who do not have proteinuria (\< 1 g/day). intervention: patients will be randomized to receive chlorthalidone (12.5 mg once daily, if needed titrated to 25 mg once daily) or amlodipine (5 mg once daily, if needed titrated to 10 mg once daily). main study parameters/endpoints: 24-hour blood pressure recording. nature and extent of the burden and risks associated with participation, benefit and group relatedness: both drugs have long been registered for the treatment of hypertension. the side-effect profile of both drugs is considered to be equal. the burden of the study for the patients are blood pressure measurements using 30-minute automated blood pressure measurement and 24-hour ambulatory blood pressure measurement.


Eligibility criteria:
inclusion criteria: * kidney transplant recipients using tacrolimus * average daytime sbp \> 140 mm hg (abpm) * egfr \> 30 ml/min (mdrd) exclusion criteria: * use of glucocorticoids, co-trimoxazole, diuretics * pregnancy * serum sodium \< 136, serum potassium \< 3.5 * proteinuria \> 1 g/day
surgery in context of terrorist attack : a survey of french surgeons

Conditions: Trauma Injury; War Injury; Surgical Procedure, Unspecified

Summary: the aim of the study is to assess the surgical knowledge of french surgeons in cas of terrorist attack.

survey was sent by email to french surgeons affiliated to french association of general surgeons. first series of questions are relative to age, qualification, usual surgical practice, in order to define different "surgical profiles". second series of questions are relative to knowledge in the field of knowledge about trauma and massive casualties surgery. third series of questions are relative to the feeling of easiness in case of various situations involving severe trauma and massive casualties. results are analyzed in order to assess the need for learning and training in the field of trauma and massive casualties surgery.

Eligibility criteria:
inclusion criteria: * french licensed and resident surgeons exclusion criteria: * medical doctor, not resident

Keywords: need for surgical training surgery and terrorist attack
vitamin d deficiency still growing

Conditions: Vitamin D Deficiency

Summary: vitamin d deficiency has become one of the most prevalent health problems in modern society. however, there has been no study that has reported the trend of vitamin d status in asia. this study investigated the trend of vitamin d status in korea between 2008 and 2014. this study is based on a representative national database acquired from the korea national health and nutrition examination surveys (knhanes) conducted from 2008 to 2014. serum 25-hydroxyvitamin d \[25(oh)d\] levels were measured by radioimmunoassay among those aged 10 yrs or older. the temporal change of vitamin d status will be statistically analyzed.

most epidemiologic studies that assessed vitamin d status in various populations have been performed in a cross-sectional design. some studies from western countries have assessed the trends of vitamin d status over the past decades. however, there was no study that investigated the trend of vitamin d status in asian population. in the present study, an assessment of the seven-year trend of vitamin d status and the prevalence of vitamin d deficiency in the korean population, based on the knhanes conducted from 2008 to 2014 was performed. the knhanes is an ongoing surveillance system that has been conducted by the division of health and nutrition survey within the korea centers for disease control and prevention to evaluate the health and nutritional status of the civilian non-institutionalized population of south korea. since the knhanes was initiated in 1998, surveys for the knhanes i (1998), knhanes ii (2001), knhanes iii (2005), knhanes iv (2007-2009), knhanes v (2010-2012), and knhanes vi (2013-2015) have been executed, and the survey for knhanes vii (2016-2018) is still in progress. the present study is based on the data acquired from the knhanes iv-vi, conducted between 2008 and 2014. among those participants, serum 25(oh)d levels were measured from 39,759 individuals (6,925 in 2008; 8,303 in 2009; 6,815 in 2010; 6,704 in 2011; 6,308 in 2012; 2,355 in 2013; and 2,349 in 2014) aged 10 years and older. serum 25(oh)d concentration was categorized into 4 levels (\<25, 25 to \<50, 50 to \<75, and ≥75 nmol/l) and the vitamin d deficiency was defined as the serum 25 (oh) d concentration \< 50 nmol/l. statistical analyses were conducted to evaluate the effects of participant characteristics (age, season, and residential region) on serum 25(oh)d concentrations, and the temporal change in the mean concentration of serum 25(oh)d over years 2008-2014.

Eligibility criteria:
inclusion criteria: * participants in the knhanes from 2008 to 2014 * participants who were examined for serum 25-hydroxyvitamin d level exclusion criteria: * participants without serum 25-hydroxyvitamin d level data

Keywords: vitamin d asia trend knhanes temporal change
indigo-2: the effect of high water intake on glucose regulation in low-drinkers

Conditions: Dehydration; Diabetes Mellitus, Type 2

Summary: previous studies have indicated increased vasopressin due to hypertonic saline infusion impairs glucose regulation. the current study will examine the effect of low water intake on glucose regulation. no currently published study has investigated the acute effect of low water intake on glucose regulation using continuous glucose monitoring over the course of a full day. the aim of the study is to observe the effect of low water intake on glucose regulation in low drinkers. the study will study the glycemic responses to standardized meals in adults during an 11-hour period in two conditions: a) high water intake and b) low water intake. it is hypothesized that the area under the glucose curve will be greater in the low water intake trial as compared to the high water intake trial


Eligibility criteria:
inclusion criteria: * healthy sedentary participants * aged 30-55 years * body mass 27.5-35.0 kg·m2 * low water intake less than 1.5 l∙day-1 (male) or 1.0 l∙day-1 (female) * 24 h urine osmolality greater than 800 mmol/kg exclusion criteria: * diabetes hba1c \>6.5% * impaired liver or kidney function * cardiovascular disease * weight change of more than 3 kg in the past month * pregnancy * previous surgery on digestive tract * exercise \>4 h/week

Keywords: dehydration vasopressin copeptin
study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated chronic lymphocytic leukemia (cll) (tugela )

Conditions: Chronic Lymphocytic Leukemia

Summary: the primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly gs-1101) to bendamustine + rituximab (br) on progression-free survival (pfs) in participants with previously treated chronic lymphocytic leukemia (cll)


Eligibility criteria:
key inclusion criteria: * previously treated recurrent cll * measurable lymphadenopathy * requires therapy for cll * has experienced cll progression \< 36 months since the completion of the last prior therapy key exclusion criteria: * recent history of a major non-cll malignancy * evidence of an ongoing infection * cll refractory to bendamustine * concurrent participation in another therapeutic clinical trial note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: zydelig cll cal-101 gs 1101 gs-1101 pi3k rituxan rituximab bendamustine leukemia idelalisib
use of navigated transcranial magnetic stimulation (ntms) in generated motor and language mapping to evaluate brain recovery following surgery

Conditions: Brain Tumor

Summary: the goal of this clinical research study is to learn about using navigated transcranial magnetic stimulation (ntms) in patients having surgery to remove a brain tumor in areas of the brain that control movement (motor function) and/or speech. ntms is a system designed to map the brain's function relating to movement and speech.

if you agree to take part in this study, you will be assessed by the ntms system before surgery and then at the same time as your routine follow-up visits, about 1, 3, 6, and 12 months after surgery. at each visit, the following will occur: * for motor mapping, pads to monitor your movements will be placed on your face, arms and legs. a coil that is used to deliver stimulation will be placed on your head. during stimulation, you will be asked to move certain muscles and will be monitored for motor responses over the course of 20 to 30 minutes. you may feel a mild tingling sensation in your arms and/or legs during stimulation. * for speech mapping, you will be shown 95 black-and-white drawings of common objects and asked to name them. during stimulation, you will be asked to name the objects again and will be monitored for changes in speech or delays. you may feel a mild tingling sensation and contraction of the muscles in the face during stimulation. this should take about 1½-2 hours to complete. you will sign a separate consent form that describes the surgery you will have and its risks in more detail. information collected during surgery will be compared to ntms information collected before and after surgery. your ntms data, health information from your routine physical exams, and data about your motor and speech function collected during surgery will be analyzed by researchers. basic information (such as your age, sex, and race) will also be collected from your medical record. length of study: your participation in this study will be over after your last (12-month) study visit. this is an investigational study. the ntms system is fda approved to map the brain's function relating to movement and speech. using the ntms system before and after surgery to check movement and speech function in patients with brain tumors in these areas is investigational. up to 20 participants will be enrolled in this study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. patients with a new or recurrent, presumed or documented, diagnosis of primary or secondary brain tumor in or adjacent to eloquent brain areas (motor, sma and language) who are scheduled to undergo tumor resection. 2. patients must sign an informed consent. exclusion criteria: 1. patients with a history of uncontrolled seizures 2. patients with metal implant or a cardiac pacemaker

Keywords: brain tumor glioma tumor resection navigated transcranial magnetic stimulation ntms brain mapping motor function speech function speech mapping
a study of e7389 liposomal formulation (e7389-lf) plus nivolumab in participants with solid tumor

Conditions: Solid Neoplasms

Summary: the primary purpose of the study is to evaluate safety and tolerability of e7389 liposomal formulation (e7389-lf) in combination with nivolumab and to determine the recommended phase 2 dose (rp2d) in phase 1b part and to evaluate objective response rate (orr) of e7389-lf and nivolumab using rp2d in each tumor type in phase 2 part.


Eligibility criteria:
inclusion criteria: 1. phase 1b part only: participants with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists (participants who will be the candidate of treatment by nivolumab monotherapy as standard therapy is acceptable) 2. phase 2 part only: participants with a confirmed diagnosis of nonresectable gastric cancer (gc), esophageal cancer (egc) or small cell lung cancer (sclc) who showed disease progression based on investigator's assessment during or after first line chemotherapy (second-line chemotherapy for gc) and did not receive any other systemic chemotherapy to advanced/recurrent disease 3. participants who meet the following criteria for biopsy; phase 1b part: participants who have accessible tumors for biopsy and agree to tumor biopsy for pre- and post-treatment of study drug (if a pre-treatment biopsy cannot be obtained due to safety issue, then an archival tumor tissue sample may be submitted.) phase 2 part: participants who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug (as an alternative to pre-treatment biopsy, tumor tissue sample taken from recurrent or advanced disease may be submitted). however, if the sponsor and the investigator discuss and agree in advance, and the participants agree to submission of archival tumor tissue, then these participants are eligible regardless of accessible tumors, and consent to biopsy is not necessary 4. life expectancy of greater than or equal to (\>=) 12 weeks 5. eastern cooperative oncology group-performance status (ecog-ps) 0-1 6. phase 2 part only: at least one measurable lesion based on recist 1.1 (lesions that have had radiotherapy or loco-regional therapies must show evidence of progressive disease to be deemed a measurable lesion) exclusion criteria: 1. diagnosed with meningeal carcinomatosis 2. participants with brain or subdural metastases or invasion are not eligible 3. active, known, or suspected autoimmune disease

Keywords: e7389 liposomal formulation nivolumab neoplasms solid tumor
registry in korea: biomimetm stent, ultimaster® stent vs. xience® stent

Conditions: Ischemic Heart Disease

Summary: comparison of safety and long-term effects of biomimetm stent and ultimaster® stent with xience® stent

a prospective, open, multicenter, and observational study will register and compare xience® groups treated in institutions such as the biomime ™, ultimaster® group prospectively registered from june 2016. the xience® group has already been registered in the previous study (smartdesk-bx), so biomimetm and ultimaster® only need to be registered. follow-up will be conducted until december 2019, and e-crf will be completed by april 2020.

Eligibility criteria:
inclusion criteria: 1. 19 years old or older 2. clinical evidence of coronary artery disease including asymptomatic ischemia, stable angina pectoris, acute coronary syndrome (unstable angina, non-st segment elevation myocardial infarction, st segment elevation myocardial infarction). 3. vessel diameter 2.25 \~ 3.5mm, stenosis more than 50% (however, the number of blood vessels, the number of lesions, and the lesion length are not limited) 4. voluntary written consent to participate in the trial exclusion criteria: 1. within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock 2. life expectancy within 2 years

Keywords: biomime, ultimaster, ischemic heart disease, des