Kornimate/medical-research-clean huggingface dataset:
feasibility and safety study comparing reg1 anticoagulation system with unfractionated heparin in elective pci

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine if it is feasible and safe to use the reg1 anticoagulation system instead of unfractionated heparin during percutaneous coronary intervention (pci) in subjects with coronary artery disease (cad).

the study drug, reg1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. regado is developing reg1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. these procedures, which include coronary artery bypass grafting (cabg) and percutaneous coronary intervention (pci), put patients at high risk for therapy-related bleeding complications. reg1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures. reg1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. the reg1 anticoagulant component (rb006) is a single-stranded, nucleic acid aptamer. rb006 selectively and potently binds to and inhibits factor ixa, a protein critical to blood coagulation. the antidote component, rb007, is a complementary nucleic acid that binds to and neutralizes rb006. the binding of rb007 to rb006 causes the predictable and rapid reversal of the rb006 effect and allows the patient's blood to return to normal.

Eligibility criteria:
inclusion criteria: * males or females scheduled for non-urgent elective pci (who do not have certain cardiac parameters) and have not been treated with uhf prior to pci. * subject able to give informed consent and comply with the protocol. * negative urine pregnancy test or documented surgical sterilization or menopausal. exclusion criteria: * subject weight \>120 kg. * recent acute coronary syndrome with elevated cardiac markers or st segment depression at rest. * evidence of clinical instability * angiographic high-risk. * a contraindication to anticoagulation or increased risk of bleeding. * use of prohibited medications or investigational drugs prior to the study. * clinically significant abnormal laboratory findings. * planned use of femoral sheath greater than a certain size. * known allergy or intolerance to drugs mandated by the study. * use of devices other than angioplasty balloons and coronary stents. * a history of licit drug abuse or illicit drug use or current evidence of such abuse. * any other factor that the investigator feels would put the subject at increased risk if participating in the protocol. * lactation. * currently enrolled in this or another clinical trial (with some exceptions). * participation in an investigational drug or device trial in the past 30 days.

Keywords: cad pci anticoagulant
acute intervention to reduce distress following sexual assault

Conditions: Drug Use; Drug Abuse; Posttraumatic Stress Disorder

Summary: the purpose of this study was to evaluate whether a brief intervention in video format delivered in the post assault medical exam setting and including education about assault reactions and instruction in and modeling of successful coping strategies would reduce post assault drug use or abuse and ptsd symptoms as compared to standard care.

the intervention being evaluated was shown at the time of the post assault medical exam and includes two main components: preparation for the medical exam; and information about and modelling of coping strategies that may help women cope in the aftermath of assault. the intervention content is delivered via video. intervention and standard care groups were compared with regard to measures of substance use and abuse and symptoms of ptsd and other potentially comorbid problems including symptoms of depression or other anxiety.

Eligibility criteria:
inclusion criteria: * seeking medical care after recent sexual assault exclusion criteria: * active psychosis * active suicidality * cognitive impairment * non-english speaking * severe injury

Keywords: rape secondary prevention intervention
identification of predictors for coronary plaque erosion in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites. the main goal of this study is to identify the predictors of plaque erosion.

plaque erosion is reported to be responsible for about one third of patients with acute coronary syndrome (acs). in the erosion study, we reported that antithrombotic therapy without stenting achieved a reduction in thrombus volume greater than 50% in over 70% of patients diagnosed with acs caused by plaque erosion. this result suggests that the conservative approach of anti-thrombotic therapy without stenting may be an option for patients diagnosed with acs caused by plaque erosion, which may be the paradigm shift in treatment of acs patients. however, at present, the only way to make an in vivo diagnosis of plaque erosion is intra-coronary optical coherence tomography (oct). if we can identify clinical factors associated with plaque erosion, we may be able to narrow down a sub-population of patients with a higher likelihood of plaque erosion. this group of patients may be stabilized with pharmacologic therapy and avoid invasive procedures, thereby preventing related complications and reducing health care burden. however, specific demographic characteristics of the acs patients with plaque erosion are not known. our group has the world's largest dataset of patients with plaque erosion and several published reports on plaque erosion. however, the study population of each study is still small and unbalanced to identify the demographic characteristics associated with plaque erosion. therefore, we propose to pool data from a large number of institutions around the world. this will provide an opportunity to identify factors associated with plaque erosion.

Eligibility criteria:
inclusion criteria: 1. diagnosed with acs upon admission to hospital, including patients with st-elevation myocardial infarction (stemi), non-st elevation myocardial infarction (nstemi), and unstable angina pectoris (uap). 2. intra-vascular oct imaging of culprit vessel. exclusion criteria: * none
an efficacy and safety study of ustekinumab in participants with active nonradiographic axial spondyloarthritis

Conditions: Nonradiographic Axial Spondylitis, Ankylosing

Summary: the purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-axspa) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-axspa).

this is a phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of ustekinumab in the treatment of participants with active non-radiographic axial spondylo arthritis. participants will receive either placebo or ustekinumab 45 or 90 milligram (mg). participants will primarily be assessed for assessment of spondylo arthritis (asas) international society criteria 20 at week 24. safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants must be classified as having nonradiographic axial spondyloarthritis (nr-axspa) based on 2009 assessment of spondyloarthritis international society (asas) criteria * must have an age at nr-axspa onset of \<= 45 years * must have at screening or active inflammation on magnetic resonance imaging (mri) as evidenced by the central readers and no radiographic sacroiliitis that fulfills the 1984 modified new york criteria * must have symptoms of active disease at screening and at baseline, as evidenced by both a basdai score of \>= 4 and a visual analogue scale (vas) score for total back pain of more than or equal to (\>=) 4, each on a scale of 0 to 10 exclusion criteria: * have radiographic sacroiliitis fulfilling the 1984 modified new york criteria * have other inflammatory diseases that might confound the evaluations of benefit from the ustekinumab therapy * have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug (dmards) other than methotrexate (mtx), sulfasalazine (ssz), or hydroxychloroquine (hcq) within 4 weeks prior to first administration of study agent * have received epidural, intra-articular, intramuscular (im), or intravenous (iv) corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to first administration of study agent * have received prior biologic therapy other than anti-tnfα * have received more than 1 prior anti-tnfα agent

Keywords: nonradiographic axial spondylitis, ankylosing ustekinumab
the breaking "bad rest" study: interrupting sedentary time to reverse frailty levels in acute care

Conditions: Sedentary Lifestyle

Summary: this study will determine whether an intervention aimed at reducing sedentary time in patients admitted to acute care will result in decreased frailty levels at hospital discharge, compared to the current standard of care. all patients will be fitted with accelerometers then randomised to the control or intervention group. the control group will receive only standard of care while in hospital. participants in the intervention group will engage in daily goal setting for time out-of-bed and have access to real-time feedback on a bedside monitor. participants in the intervention group will also received assisted mobilization if they have not met their daily goal by the late afternoon. the main outcome is frailty, assessed by a frailty index.

the objective of this study is to determine if an intervention designed to reduce sedentary time during a patient's stay in acute care will reduce patient's frailty levels more so than current standard of care. this study will be conducted at a single-centre, but will be a stratified, block randomised control trial. fifty participants will be recruited within 24 hours of admission to a geriatric acute care unit. both groups will be fitted with a device that measures sedentary and active time (accelerometer). participants in the intervention group will have a daily goal for activity and will be provided with real-time feedback on attainment of that goal displayed on a bedside tablet. participants in the intervention group who do not independently achieve their goal will be assisted in reducing their sedentary time in the afternoon and/or early evening to the maximum level of their ability; this level will be determined in consultation with the healthcare team. the primary outcome is a change in frailty during hospitalization, measured using a 30-item frailty index. the data collection phase is approximately 10 months. data analysis will take an additional six months (16 months total). knowledge-users will be involved during all stages of the project. the data generated from this study will enable us to scale up this intervention nationally and internationally. if the intervention is successful, it will warrant a study to implement the intervention as part of standard care. ultimately, this study will inform guidelines to limit patients' sedentary behaviors in acute care.

Eligibility criteria:
inclusion criteria: * anticipated hospital length of stay \>1 day * patient or care partner able to communicate in english exclusion criteria: * patient unable to provide informed consent and care partner not available to provide consent * bedridden prior to hospital admission * previous participation in our study (i.e. readmission during data collection phase) * end-of-life or waiting for long-term care facility * patient is admitted to a shared room with a current study participant.

Keywords: frailty hospitalization acute care older adults intervention
a long-term follow-up study of participants exposed to react

Conditions: Diabetic Kidney Disease; Chronic Kidney Diseases

Summary: the purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation react injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (ckd).

this observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with renal autologous cell therapy in previous interventional clinical studies (rmcl-002, regen-003, regen-004) will be monitored for up to five years with alternating in clinic and phone visits.

Eligibility criteria:
inclusion criteria: * the participant must have received gelatin-hydrogel formulation react in a previous trial (rmcl-002, regen-003, regen-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol. exclusion criteria: * the participant did not receive react in a previous trial for the treatment of chronic kidney disease.

Keywords: react dkd ckd
therapeutic potential of kappa-opioids against cocaine - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to characterize the effects of enadoline compared to hydromorphone and butorphanol.


Eligibility criteria:
inclusion criteria: opiate experienced, healthy exclusion criteria: physical dependence on opioids, barbiturates or alcohol

Keywords: cocaine dependence
creation of a patient database for silicon patient simulation, glucose sensor variability and pharmacokinetic study of debiotech jewelpump

Conditions: Type 1 Diabetes

Summary: the aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. this database will integrate the measures of blood glucose and the glycaemia level of the dexcom sensor on a regular time, the injections of insulin delivered by debiotech jewelpump and the level of insulin in the blood. this database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. a study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the jewelpump either the usual pump of the patient.


Eligibility criteria:
inclusion criteria: * patients with diabetes type 1 treaty by external insulin pump * duration of diabetes than 2 years or c indosable peptide * practicing insulin functional (if) or food plan sets * patient having a hba1c \< 10% * patient age over 18 years * patient having signed the form of collection of free consent and informed * patient affiliated with the social security exclusion criteria: * patients with diabetes type 2 * patient pregnant or likely to be * all serious pathologies that can interfere with the study (in particular kidney or heart failure) * psychiatric pathologies incompatible with the study
pain control differences between oxycodone and ibuprofen in children with isolated forearm injuries

Conditions: Forearm Injuries; Pain, Acute; Pediatric ALL

Summary: children presenting to the emergency room with the chief complaint of forearm injury and/or pain will be randomized to receive oral oxycodone or ibuprofen to control pain.

a randomized, blinded cohort study. consented patients will be randomized to receive either ibuprofen or oxycodone after initial rn patient assessment in emergency department triage determines a need for radiographs to evaluate for possible forearm fracture. pain assessment scores will be determined at triage and at 30-minute intervals throughout the patient's course until the patient is discharged home or additional analgesic medication is administered.

Eligibility criteria:
inclusion criteria: 1. 6 to 17 year old children presenting for care in the st. louis children's hospital emergency department 2. suspected acute (within 24 hours) isolated forearm fracture at the time of initial triage assessment 3. american society of anesthesiologist physical status (asa-ps) classification of i or ii 4. child with parent or legal guardian. exclusion criteria: 1. multiple injuries 2. known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones 3. administration of any opioid within 2 hours prior to presentation 4. non-english speaking 5. foster care, police custody, presenting without legal guardian

Keywords: oxycodone ibuprofen
b-thalasaemia trait and its possible cardioprotective role

Conditions: Beta-Thalassemia Trait; Coronary Artery Disease

Summary: our purpose is to investigate whether thallasaemia trait offers protection against cardiovascular events and whether this can be applied to specific characteristics of these people ( better lipid profile , better blood pressure profile) as scientific literature suggests.

thallasaemia is a major problem , especially in countries around the mediterranean sea.on the other hand ,thallasaemia trait has been shown ,in a small number of studies , to have a possible protective role against cad and stroke.these kind of studies have been contacted in greece also ,and usually they enroll a small number of participants. in the study, investigators will enroll 2500 subjects who serve in military units in thesally greece. firstly investigators will estimate the prevalence of thallasaemia trait in this population , as it is very high in this region and at the same time investigators will retrospectively record data from their personal files (which are annually recorded).

Eligibility criteria:
inclusion criteria: 1. voluntary participation, 2. subjects with thalassemia treat will be confirmed of their treat by electrophoresis - exclusion criteria: -

Keywords: thalassemia trait coronary stroke
compliance with ldl-lowering therapy (study p05467)(completed)

Conditions: Coronary Heart Disease; Hypercholesterolemia; Hyperlipidemia

Summary: this observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with european guidelines. the purpose of the study is to evaluate the percentage of these patients that reach target ldl levels. additionally this study will measure the patient's compliance to treatment as assessed by counting the returned tablets. both assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks after the first visit.


Eligibility criteria:
inclusion criteria: * willingness to participate in the study * 18 years of age or more * clinically established cardiovascular disease to be considered as patients in secondary prevention * prior therapy with any statin without achieving goal (2.5 mmol/l of ldl cholesterol) at last lipid check performed exclusion criteria: * none
open-label placebo treatment for acute postoperative pain

Conditions: Postoperative Pain

Summary: this study is to evaluate whether the amount of morphine intake in acute postoperative pain following minimally invasive transforaminal lumbar interbody fusion (tlif) can be decreased with an open-label placebo (olp) intervention (comprising the administration of sodium chloride (nacl) injections and an evidence-based treatment rationale) in comparison to a "treatment as usual" (tau) control group.


Eligibility criteria:
inclusion criteria: * signed informed consent * scheduled to receive a tlif procedure at university hospital basel (usb) * 18 years or older * german speaking * able to understand the study and its outcome measures exclusion criteria: * known chronic pain, which is unrelated to problem targeted by the surgery * known neuromuscular disease * known mental disorders * known drug or massive alcohol intake or of other psychoactive substances * known kidney or liver disease (glomerular filtration rate (gfr)/ gfr \< 30) * contraindications to the class of drugs under investigation, e.g., known hypersensitivity or allergy to the investigational product * parallel participation in another study with investigational drugs * more than 30 mg/day (equivalent dose of oral morphine) preoperative opioid consumption

Keywords: postoperative pain open-label placebo morphine transforaminal lumbar interbody fusion
evaluation of the recovery rate and postoperative incontinence of surgical fistulas in a cohort of a reference centre

Conditions: Anal Fistula

Summary: fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist. the proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. the treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. it sometimes requires several times of surgical treatment. the study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.


Eligibility criteria:
inclusion criteria: * patient over the age of 18, patient with an anus fistula with indication for surgical treatment exclusion criteria: * cutaneous suppuration, without fistula (e.g., verneuil disease, boil)

Keywords: anal fistula anal infection
continuous dosing of bay73-4506 in patients with advanced malignancies

Conditions: Neoplasm

Summary: continuous dosing of bay73-4506 in patients with advanced cancer


Eligibility criteria:
inclusion criteria: * 18 years * patients with advanced, histologically or cytologically confirmed solid tumors, malignant lymphomas, or multiple myeloma refractory to any standard therapy * radiographical, hematological or clinically evaluable tumor * eastern cooperative oncology group (ecog) performance status of 0-2 * life expectancy of at least 12 weeks * adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements: * total bilirubin less than or equal to 1.5 x upper limit of normal (uln) * signed informed consent must be obtained prior to any study specific procedures exclusion criteria: * history of cardiac disease: congestive heart failure (chf) \> new york heart association (nyha) class ii; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months or unstable angina or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) * uncontrolled hypertension defined as systolic blood pressure \> 150 mm hg and/or diastolic blood pressure \> 90 mmhg, despite optimal medical management * history of hiv infection or chronic hepatitis b or c * active clinically serious infections (\> grade 2 nci common terminology criteria for adverse events v3.0) * symptomatic metastatic brain or meningeal tumors unless the patient is \> 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry and is clinically stable with respect to the tumor at the time of study entry. patients with brain metastases must not be undergoing acute steroid therapy or steroid taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies) * substance abuse, medical, psychological or social conditions that may interfere with the patient178s participation in the study or evaluation of the study results * radiotherapy to the target lesions within 3 weeks prior to day 1, cycle 1 (first dose of study drug). (palliative radiotherapy will be allowed). radiotherapy to the target lesions during study will be regarded as progressive disease * previous or concurrent cancer which is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[ta, tis and t1\] or any cancer curatively treated \> 3 years prior to study entry.

Keywords: oncology patients with advanced disease bay73-4506