Kornimate/medical-research-clean huggingface dataset:
febrile whole blood specimen collection and testing

Conditions: Febrile Infection; Anthrax

Summary: whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. collection sites will consent patients and collect one (1) 4 ml whole blood sample from adults and either (1) 2 ml pediatric whole blood sample or 0.5 ml whole blood sample collected in a micro collection container from pediatric patients from each patient enrolled into the study. study site will test whole blood samples received from collection sites daily using the applied biosystems™ bacillus anthracis detection kit. data generated will demonstrate product specificity when testing febrile whole blood samples.

whole blood samples will be collected from febrile patients presenting with fever of unknown origin and flu-like syndromes. collection sites will be advised of collection requirements specific to patient population with the goal of collecting samples form patient between the ages of 2-89 years of age. samples collected will be de-identified and assigned a specific study number. study numbers and labels will be provided to collection site by the study monitor. samples must be shipped to mriglobal or designated study site on the day of collection. collection sites will consent patients and collect one (1) 4 ml whole blood sample from adults and either (1) 2 ml pediatric whole blood sample or 0.5 ml whole blood sample collected in a micro collection container from pediatric patients (anticoagulant: k2edta or defined alternative) from each patient enrolled into the study. patients may not be enrolled in the study more than once. patients considered for enrollment will be logged on an enrollment log. log must be reviewed by the site prior to considering a patient for study enrollment to confirm enrollment status. samples collected will be de-identified and assigned a specific study number. study numbers and labels will be provided to collection site by the study monitor. study site will accept or reject samples based on shipping verification procedures and then process samples acceptable for testing within 24 hours of receipt. sample testing must be performed in accordance with the applied biosystems™ bacillus anthracis detection kit instructions for use. at study start, study site will test whole blood samples received from collection sites daily (e.g. tuesday, wednesday, thursday, and friday) using the applied biosystems™ bacillus anthracis detection kit. no reference testing will be required since the study is designed only to demonstrate product specificity. samples are assumed to be negative for bacillus anthracis. a minimum of 50, but likely 100 febrile whole blood samples will be tested at mriglobal. data generated will demonstrate product specificity when testing febrile whole blood samples.

Eligibility criteria:
inclusion criteria: * fever exclusion criteria: * none
study of blood concentrations and physiologic effects of levosimendan given during heart surgery

Conditions: Heart Failure

Summary: the purpose of this study protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac manipulation during off pump surgery in patients who require the drug for inotropic support (improved heart function) and the associated hemodynamic variables (vital signs). levosimendan is one of the first agents in a new class of drugs used to treat heart failure and works via a unique mechanism called calcium sensitization, that makes the heart beat more efficiently. levosimendan also has unique effects on the blood vessels, as well as causing relaxation, an important therapeutic approach of heart failure therapy.

this is a non-randomized trial, and the patients will be assigned to one of three dose groups following cardiopulmonary bypass or prior to manipulation of the heart in the off pump group. a total of 30 patients will be enrolled into this study, 20 off-pump and 10 subjects on pump. levosimendan is approved in europe for the treatment of decompensated heart failure. it improved cardiac function without increasing energy demands. the subject's enrollment ends at day 7 or day of discharge, whichever comes first.

Eligibility criteria:
inclusion criteria: * at least 21 years of age * less than 80 years of age * asa class iii-iv * scheduled for elective cardiac surgery * signed informed consent * history of heart failure, and/or left ventricular ejection fraction \<50% exclusion criteria: * emergency surgery * withdrawal of consent * uncontrollable ventricular arrhythmias * obstructive cardiomyopathy * confirmed pregnancy test for women of child-bearing potential

Keywords: heart failure cardiac surgery pharmacokinetics pharmacodynamics
extension trial of deforolimus (ridaforolimus, mk-8669) in participants with advanced cancer (mk-8669-038)

Conditions: Advanced Cancers

Summary: to describe the long-term safety of deforolimus (ridaforolimus, mk-8669) in participants for whom a clinical benefit has been established in a prior parent trial (mk-8669-013, nct00060645; mk-8669-016, nct00112372; and mk-8669-028, nct00704054) with deforolimus and/or in those who remain in long-term follow-up.


Eligibility criteria:
inclusion criteria: * must have participated on a deforolimus (ridaforolimus) parent trial * must have derived a clinical benefit from the parent trial * is not on any other anti-cancer treatment(s) unless the therapy was allowed on the parent protocol * eastern cooperative oncology group (ecog) performance status less than or equal to 2 if the participant is scheduled to receive treatment with deforolimus; no requirement if the participant is included for follow-up purposes only * participant of childbearing potential must have a negative pregnancy test within 7 days prior to screening and must use approved contraceptive from screening until 30 days after the last dose of study drug * signed informed consent exclusion criteria: * has not participated on a parent trial * women who are to receive study drug who are pregnant or lactating * any condition in the investigator's judgment that renders the participant unable to fully understand and provide informed consent and/or comply with the protocol
open-label study of nelotanserin in lewy body dementia with visual hallucinations or rem sleep behavior disorder

Conditions: Lewy Body Dementia; Dementia With Lewy Bodies; Parkinson's Disease Dementia; Visual Hallucinations; REM Sleep Behavior Disorder

Summary: this study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (vhs) and rapid eye movement (rem) sleep behavior disorder (rbd) in subjects with lewy body dementia (lbd).

this is a multi-center open-label, long-term study in lbd subjects with rbd and/or vhs. eligible subjects who completed a previous nelotanserin vh or rbd study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.

Eligibility criteria:
inclusion criteria: * subjects with lbd who completed a previous nelotanserin vh or rbd study exclusion criteria: * subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

Keywords: lewy body dementia dementia with lewy bodies parkinson's disease dementia visual hallucinations rem sleep behavior disorder
fast track concept for transfemoral tavi

Conditions: Heart Valve Diseases; Complication,Postoperative

Summary: transcatheter aortic valve implantation (tavi) in high-risk patients with severe aortic valve stenosis has developed itself until today as an established minimally invasive alternative procedure worldwide, with a focus on the transfemoral access (tf-tavi). meanwhile a number of studies have shown that analgosedation for patients undergoing tf-tavi is a safe and feasible alternative to general anaesthesia (1). the median length of stay in hospital in europe is currently 8 days independent to the anesthesia management (2). in the university hospital schleswig-holstein, campus kiel, a new tf-tavi fast-track-concept has been implemented in june 2018. the main intraprocedural aspects of the concept are the preprocedural fluid optimization using transthoracic echocardiography, the idea to decrease or omit the central venous line and the urinary catheter, if reasonable, and finally the individualized low-dose, bolus-based as.

the investigators are going to monitor 200 patients in 2019 treated with the newly established fast-track concept. during the premedication visit, the investigators informed the patients that the intention is to perform the tf-tavi, if acceptable, solely in local anaesthesia, in order to minimize potentially adverse pharmacological central effects by analgosedation. after insertion of two peripheral venous lines and an arterial line, monitoring of cerebral oxygenation using near-infrared spectroscopy was established. transthoracic echocardiography has been performed to evaluate volume status, using the inferior vena cava collapsibility index. additionally, cardiac output and ejection fraction was calculated. based on the data of the investigators and current data from the literature, the investigators assume a postoperative hospital stay of 8 days after tf-tavi. with a possible reduction of the hospital stay by about 25%, the investigators calculated a case number of 100 patients per group. the study is designed with a control group under standard therapy. data are recorded and analyzed descriptively. qualitative comparisons will be made in the discussion of previously published data.

Eligibility criteria:
inclusion criteria: * scheduled for transfemoral tavi * informed written consent exclusion criteria: * rejection by the patient * switching to another procedure

Keywords: length of stay in hospital transfemoral transaortic valve implantation
efficacy of oncoxin plus viusid in the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to assess the efficacy of oncoxin+viusid administration in the treatment of rheumatoid arthritis. the duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. the estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. the primary outcome measure: das28 score will be assessed at the end of the study.


Eligibility criteria:
inclusion criteria: * treatment-naive subjects with recent onset rheumatoid arthritis * signed informed consent exclusion criteria: * subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset * subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis

Keywords: oncoxin viusid dietary supplements rheumatoid arthritis
a study to evaluate the safety of qcz484 in healthy and mild hypertensive subjects

Conditions: Mild Hypertension

Summary: this is a randomized, double-blind, placebo-controlled study including part a single ascending dose (sad) in healthy subjects and part b single dose in subjects with mild hypertension.

phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of qcz484. in part a, single ascending doses of qcz484 are tested in healthy subjects, while in part b, single doses of qcz484 are tested in subjects with mild hypertension. one dose of qcz484 is administered subcutaneously. this study was started by argo biopharma, and global sponsorship was transferred to novartis.

Eligibility criteria:
inclusion criteria: * healthy males or females aged 18 to 60 years, inclusive, at the time of informed consent. (part a only). * males or females aged 18 to 72 years, inclusive, at the time of informed consent (part b only). * body mass index (bmi) \>= 18 and \ 50 kg (part a only). * body mass index (bmi) \>=18 and \ 50 kg (part b only). * triplicate 12-lead electrocardiogram (ecg) after \>5 minutes resting without clinically significant findings at screening and day -1. * mean sitting systolic blood pressure (sbp) of \>=130 and \<160 mm hg (part b only). exclusion criteria: * history of hypotension or orthostatic hypotension. * history of syncope within 1 year. * sbp \<90 mmhg or dbp \<60 mm hg at screening (part a only). * clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening. * any liver function panel analyte value \> 1.2 ×upper limits of normal (uln) at screening.

Keywords: hypertension qcz484
olaratumab (ly3012207) patient access for soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this study is to continue to provide olaratumab to eligible patients who are currently receiving olaratumab commercially for the treatment of soft tissue sarcoma (sts).


Eligibility criteria:
inclusion criteria: * are currently receiving olaratumab and who, in consultation with their treating physician, want to continue their course of therapy. * have metastatic or locally advanced unresectable soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. * have given written informed consent. * have an absolute neutrophil count (anc) ≥1,000/microliter. * females of childbearing potential and males must agree to use highly effective contraceptive precautions during treatment with olaratumab and up to 3 months following the last dose of olaratumab. a highly effective method of birth control is defined as one that results in a low failure rate (that is, \<1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (iuds), sexual abstinence, or a vasectomized partner. exclusion criteria: * breastfeeding (patients who discontinue breastfeeding would be considered eligible).
coin: a pilot study of cash transfers to improve outcomes in low-income preterm neonates and their families

Conditions: Preterm Birth

Summary: the investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among medicaid-eligible birthing parents of preterm infants in a single neonatal intensive care unit (nicu) in pennsylvania. the investigators will measure the feasibility and acceptability of the intervention, birthing parents' lived experiences of having a preterm infant and the impacts of cash transfers, and conduct a preliminary assessment of efficacy on birthing parent psychological stress and ability to invest in their infant's care.

poverty is an important social determinant of health and contributes to child heath disparities. among preterm infants, low-income is associated with worse long-term health outcomes. given the connection between poverty and poor health outcomes, an urgent need exists to move beyond describing health disparities for low-income infants and towards interventions that interrupt these pathways in early childhood to improve outcomes. a growing body of literature suggests that monthly unconditional cash transfers (ucts) - no strings attached monthly cash payments - to low-income families may be an effective intervention to reduce poverty and financial stress, improve psychological health, and improve child health outcomes. however, current studies on ucts focus primarily on term infants or heterogenous samples of children, with only a single pilot delivering direct financial assistance to low-income preterm infants. thus, despite well-documented disparities in outcomes for low-income preterm infants, the impact of ucts among low-income preterm infants and their families remains unknown. toward that end, the investigators are conducting a pilot randomized controlled trial of unconditional cash transfers among medicaid-eligible birthing parents of preterm infants in a single nicu in pennsylvania. the investigators have three specific aims: aim 1: to determine the feasibility and acceptability of randomizing high-value ($325/month) and low-value ($25/month) ucts to low-income birthing parents of preterm infants beginning in the first month of life. aim 2: to examine birthing parents' lived experiences managing the financial impact of having a preterm infant and the perceived impact. exploratory aim 3: to conduct a preliminary assessment of the efficacy of monthly ucts on birthing parent psychological stress and ability to invest in their infant's care, recognizing the pilot is not designed to be powered for statistical significance.

Eligibility criteria:
inclusion criteria: * medicaid-insured or uninsured by meets income requirements for medicaid-eligibility, over 18 years old, speaks english or spanish fluently, lives in philadelphia county, has an infant born \>=22 and \<36 weeks gestational age exclusion criteria: * reports being "highly likely" to move to a different state in the next 12 months, reports planning to place the infant up for adoption at the time of enrollment

Keywords: preterm birth unconditional cash transfers parental stress breastfeeding
safety and efficacy of insulin detemir in combination with oads in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (oad) treatment in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 months since diagnosis * insulin naive subjects * oad treatment for at least 4 months with max. two oad treatments * body mass index below 30.0 kg/m2 * hba1c between 7.0-11.0% exclusion criteria: * oad treatment with three or more oads * secondary diabetes * known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the investigator * uncontrolled hypertension * known or suspected allergy to trial product or related products
safety study of surgical technique to treat acute dorsal trans-scaphoid perilunate dislocations

Conditions: Operative Time; Grip Strength; Pain; Functional Status

Summary: the purpose of this study is to determine a surgical technique is effective in the treatment of acute dorsal trans-scaphoid perilunate dislocations.

open reduction and internal fixation is an effective method of treating acute trans-scaphoid perilunate dislocations. we study a new surgical technique that allows for early wrist excises postoperatively. we compare this technique to inoue et al. 's techniques affect the objective and subjective outcomes. we also compared the long-term outcomes of these two procedures performed in similar patient groups.although both groups had satisfactory results with regard to their pain relief, sufficient grip strength and union of scaphoid fracture, the technique using in group i was more easily and quickly to perform. it allows early postoperative excises and results better functional wrist range of motion.

Eligibility criteria:
inclusion criteria: * clinical treatment of acute trans-scaphoid perilunate dislocations * must have open reduction and internal fixation exclusion criteria: * patients whose age under 18 years * associated with severe crush, avulsion, or opened injury

Keywords: acute trans-scaphoid perilunate dislocations open reduction and internal fixation kirschner-wire range of motion
effect of non-anemic iron deficiency on outcome following off-pump coronary revascularization

Conditions: Coronary Artery Bypass, Off-Pump; Iron Deficiencies

Summary: this is a single center retrospective study of patients who underwent off pump coronary artery bypass surgery between 2016.11\~2023.05. from this patient group, preoperatively non-anemic patients were selected and were divided into 2 cohorts according to their preoperative iron status; iron replete and iron deficient. these two cohorts were compared to evaluate the effect of preoperative iron deficiency on patient outcomes. the primary end point was the occurrence of composite morbidity/mortality end points which were: in hospital mortality, acute kidney injury (aki), stroke, deep sternal infection, hemostatic reoperation, prolonged mechanical ventilation of more than 24hours, delirium and postoperative myocardial infarction. occurrence of any one of these outcomes counted as primary end point met. secondary outcome was to evaluate and compare hemoglobin recovery of iron replete and deficient patients until one year after surgery.


Eligibility criteria:
inclusion criteria: * patients who received off pump coronary artery bypass surgery (opcab) between 2016.11.01-2023.05.31 exclusion criteria: * preoperative anemia (male hb \<13g/dl, female hb\<12g/dl) * emergency surgery * redo-off pump coronary artery bypass surgery * minimally invasive coronary artery bypass surgery * opcab in conjunction with other cardiac surgical procedures (e.g. valve surgery, graft replacement surgery of the aorta) * intraoperative on pump conversion * lack of sufficient preoperative data (ferritin, transferrin saturation, c-reactive protein) to determine iron status * administration of intravenous iron within 4 weeks or parenteral iron of more than 2 weeks prior to surgery * enrollemnt in other clinical studies
treatment of post-dural puncture headache in postpartum patients: sphenopalatine ganglion block to epidural blood patch.

Conditions: Headache

Summary: the purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period.

the purpose of this research study is to compare the effectiveness of a sphenopalatine ganglion block to an epidural blood patch for post-dural puncture headache relief in randomized postpartum parturients over a 48 hour period. a known dural puncture is defined as free flow of cerebral spinal fluid (csf) during neuraxial placement. an unknown dural puncture is defined as neuraxial placement where free flow of csf is not appreciated, however the patient is diagnosed with a post-dural puncture headache as defined by the international classification of headache disorders.

Eligibility criteria:
inclusion criteria 1. age 18 years or age or greater 2. postpartum obstetric parturient who was previously admitted to uch. 3. diagnosis of post-dural puncture headache based on the international classification of headache disorders: 1. dural puncture has been performed 2. headache has developed within 5 days of the dural puncture 3. not better accounted for by another ichd-3 diagnosis. 4. occurring immediately or within seconds of assuming an upright position and resolving quickly (within 1 minute) after lying horizontally. exclusion criteria 1. refusal to participate in the study 2. placement of an ebp within the past 5 days 3. allergy and/or intolerance to any the study materials 4. contraindications to an ebp 5. plan for therapeutic anticoagulation post-partum