Kornimate/medical-research-clean huggingface dataset:
pharmacologic optimization of voriconazole

Conditions: Invasive Fungal Infection; Hematological Malignancy

Summary: the objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (tdm) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to the current standard of care.

patients with haematological malignancies and chemotherapy-induced prolonged neutropenia are at risk for severe bacterial and fungal infections. these opportunistic infections can result in prolonged hospital stay, increases costs and greater mortality. voriconazole has now been recommended as the first line agent for invasive pulmonary aspergillosis. retrospective observational studies of voriconazole serum concentration suggest that serum concentration correlate with toxicity and clinical response. these observations were however made in small series of patients and data were collected retrospectively. these inherent methodological flaws make it impossible to draw definite conclusions about the effect of voriconazole serum level monitoring on the outcome of ia, and therefore considered insufficient proof to recommend voriconazole concentration determination in blood as standard of care. the impact that so called serum concentration guided dosing of voriconazole will have on treatment success can only be evaluated through a prospective randomized clinical trial. for this purpose, we designed a prospective stratified cluster randomized cross-over trial of therapeutic drug monitoring in patients with haematological disease who have developed ia. the order of periods (tdm or standard of care, each 12 months) will be randomized per centre. during the tdm episode, the voriconazole dosage will be adjusted to achieve trough blood concentrations in a predefined window of 2-5 mg/l. a sample size of n=192 is needed to detect a 20% absolute reduction in the number of treatment failures (40% to 20 %) compared to control.

Eligibility criteria:
inclusion criteria: * are at least 18 years of age * have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant * proven, probable or possible invasive fungal disease according to the eortc/msg criteria * treatment with voriconazole exclusion criteria: * allergic to voriconazole or its excipients * age below 18 years

Keywords: invasive fungal infection hematological malignancy voriconazole therapeutic drug monitoring
study of rebamipide eye drops to treat dry eye

Conditions: Keratoconjunctivitis Sicca

Summary: the purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).

there is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. the goal of this study is to assess the impact of rebamipide on dry eye symptoms.

Eligibility criteria:
inclusion criteria: * must have symptoms of dry eye for a minimum of 6 months * must be able to sign and date an informed consent exclusion criteria: * presence of anterior segment disease * glaucoma or ocular hypertension * using restasis * use of topically instilled ocular medications during study * use of contact lenses * history of ocular surgery within 12 months * females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception * presence of stevens-johnson syndrome * any anticipated change in medication through-out study * concurrent involvement in another study or previous receipt of this drug * cannot be safely be weaned off of ocular medications

Keywords: dry eye keratoconjunctivitis sicca
the effect of puerarin injection on carotid intima-media thickness in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (cimt) in rheumatoid arthritis (ra) patients despite routine anti-rheumatic treatment.

* controlled, randomized trial * ra patients under routine anti-rheumatic care were randomized to receive the treatment with or without 400 mg puerarin injection * assessments were made at entry, 12 and 24 weeks * the overall sample size was assessed before the enrollment * randomization was performed using concealed random allocation method * the collected data was processed and assessed by two reviewers * all the measurement and analysis procedures concerning cimt were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment * the reproducibility of the ultrasonographic method was test before the trial

Eligibility criteria:
inclusion criteria: * patients with a definite diagnose of rheumatoid arthritis(ra) were included if they met the classification criteria for ra established by the american rheumatism association (acr) and european league against rheumatism (eular) in 2010 * aged from 18 to 75 years * without conflict to the written, informed consent signed prior to the enrollment * no severe hepatic or renal disorders * no known carotid artery stenosis * no coagulation disorders * no hypertension exclusion criteria: * being in pregnancy, lactation period or under a pregnancy plan * being allergic to the test drug * not compatible for the trial medication * without full legal capacity

Keywords: puerarin rheumatoid arthritis atherosclerosis carotid intima-media thickness
efficacy of bupropion for attention deficit hyperactivity disorder (adhd) in adults

Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Substance Use Disorder (SUD)

Summary: the investigators propose to conduct an open study to evaluate the efficacy and tolerability of bupropion sr using clinically relevant doses in adhd adults with a recent history of or current substance use disorders. we hypothesize that bupropion sr will be effective in treating adhd in this population.


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 years old or older, up to 60 years old. * patients with the diagnosis of attention deficit hyperactivity disorder (adhd), by dsm-iv, as manifested in clinical evaluation and confirmed by structured interview. * patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included) exclusion criteria: * any clinically unstable medical condition * clinically significant abnormal baseline laboratory values * mental retardation (i.q. \<75) or organic brain disorders * seizure disorder * patients with a history or an eating disorder including anorexia or bulimia nervosa * pregnant or nursing females * patients with current bipolar disorder * psychotic disorder of any type * patients on psychotropics known to treat adhd (i.e. stimulants, tricyclics) * patients receiving psychotherapy known to treat adhd (i.e. cognitive or cognitive/behavioral psychotherapy) * patients demonstrating active withdrawal from substance abuse
a study on the effects of feeding and feeding methods on breathing pattern in very low birth weight preterm infants

Conditions: Infant, Premature; Apnea

Summary: in this study, we want to see how feeding affects breathing in small premature babies. using a special feeding tube in the stomach, we can measure how the diaphragm (a large breathing muscle) might be affected by feeding. we also want to see if slowing down the feeding may lessen this effect.

premature babies may have pauses in breathing known as apnea, which may require invasive treatment. the exact cause of apnea is unknown, and may be related to a combination of brain, gut, and lung immaturity. research in premature babies suggests that feeding may affect lung functions, but such effects may be lessened if feeds are given at a slower rate. further research showed that the diaphragm, an important breathing muscle, may be fatigued by a full stomach. we speculate that, in premature babies, feeding might tire the diaphragm, thus impairing lung function and possibly causing apnea. we plan to study 10 stable premature babies less than 23 weeks and 1.25 kilograms at birth. by inserting a special feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (eadi). by analysing eadi before and after feeding, we want to directly measure how feeding might affect lung functions. we also want to compare feeding at the usual rate (5-15 minutes) versus a slower rate (90 minutes) to see how their effects on lung functions might differ. this important study will help us determine the most appropriate treatment for premature babies with apnea related to feeding.

Eligibility criteria:
inclusion criteria: * preterm infants \>23 weeks gestation * birth weight \<1250 grams * not requiring full mechanical ventilation * tolerating full regular bolus feeding for at least 48 hours exclusion criteria: * congenital and acquired problem of the gastrointestinal tract * phrenic nerve injury and/or diaphragm paralysis * esophageal perforation/tracheoesophageal fistula * congenital/acquired neurological deficit and/or seizures * hemodynamic instability * congenital heart disease (including symptomatic patent ductus arteriosus) * undergoing treatment for sepsis or pneumonia * use of muscle relaxants, narcotic analgesics, or gastric motility agents

Keywords: infant, premature infant, very low birth weight apnea feeding methods diaphragm
transcranial magnetic stimulation on neural and behavioral facets of social cognition in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this study will evaluate the effects of repetitive transcranial magnetic stimulation (rtms) on neural and behavioral facets of social cognition in autism spectrum disorder (asd). participant visits will include a baseline assessment of neuropsychological, cognitive and behavioral function, and an eeg (electroencephalogram) and eye-tracking session to measure neural and visual attentional social response before and after administration of tms.

broad ranging social cognition difficulties are hallmark areas of impairment in autism spectrum disorder (asd), and they are subserved by specific neural systems underpinning social perception and processing that are recognized to be atypical in asd. considering the neurodevelopmental nature of the disorder, and the recent findings regarding aberrant neuroplasticity in asd, repetitive transcranial magnetic stimulation (rtms) holds promise to directly modulate brain activity in these systems. the objective of this research proposal is to utilize a multimodal approach to provide a proof-of-concept for the ability of rtms to (a) influence functioning in the brain systems involved in social asd symptomatology and (b) modify associated social cognitive behaviors in adults with asd. toward achieving this objective, we propose to assess critical aspects of social cognition using the electroencephalogram (eeg), event-related potentials (erps), eye-tracking (et), and behavioral tasks prior to and following a single rtms session to provide preliminary insight into the potential of rtms as a tool to modify social brain function in cognitively able adults with asd.

Eligibility criteria:
inclusion criteria: * individuals between the ages of 18 and 40 years old with typical development or with a diagnosis of autism spectrum disorder. * able to participate in an eeg and eye-tracking experiment exclusion criteria: * participants reporting significant head trauma or serious brain illness * participants with major psychiatric illness that would preclude completion of study measures. * participants with a history of serious medical illness, stroke, seizures, epileptiform eeg abnormalities, or family history of seizures. * participants taking prescription medications that may affect cognitive processes under study. * participants who have taken alcohol or recreational drugs within the preceding 24 hours. * females of known/suspected pregnancy or who test positive on a pregnancy test. * participants with a history of metalworking or injury by shrapnel or metallic objects are also exclude

Keywords: tms
accuracy of point of care (poc) or in-office urine drug testing (immunoassay) in chronic pain patients

Conditions: Chronic Pain

Summary: accuracy of point of care (poc) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (lc/ms/ms)

recruitment is indicated in patients with chronic pain management with or without controlled substance therapy. this is a diagnostic accuracy study performed in an interventional pain management referral center in the united states.

Eligibility criteria:
inclusion criteria: • chronic pain management with or without controlled substance therapy. exclusion criteria: none

Keywords: controlled substances opioids benzodiazepines illicit drugs immunoassay drug testing point of care (poc) testing liquid chromatography tandem mass spectometry
salvage of myocardial infarction documented by mri in patients undergoing rescue percutaneous coronary intervention

Conditions: Myocardial Infarction; Myocardial Ischemia

Summary: atherosclerotic disease is responsible for one third of all deaths annually and is a major cause of comorbidities. while atherosclerosis is by itself a benign disease, it often leads to complications such as acute myocardial infarction with st-segment elevation. rescue angioplasty is indicated if thrombolytic therapy fails. however, the benefits in reducing mortality and the amount of myocardium effectively saved are not well established. the development of new tools, including cardiac magnetic resonance imaging to identify myocardial area at risk and infarcted increased diagnostic accuracy. however, unlike the context of primary angioplasty, little is known about the relation between coronary epicardial and microvascular flow after rescue angioplasty and myocardial salvage. the objective of this study is to evaluate whether there is a relation between these flows and myocardial salvage identified by magnetic resonance imaging (mri). at the end of this research, the investigators hope to contribute to a better understanding of coronary flow and its relation to the amount of heart muscle saved after rescue angioplasty. this is an important information that can help understand which cases benefit most from rescue angioplasty.


Eligibility criteria:
inclusion criteria: * patients with st segment elevation myocardial infarction (stemi) who underwent thrombolysis within 12 hours of chest pain and present clinical and/or electrocardiogram (ekg) signs of failed thrombolysis with indication of rescue percutaneous coronary intervention (pci). exclusion criteria: * patients with contraindication to cardiac magnetic resonance imaging (mri) (pacemaker, aneurysm clip, claustrophobia, hemodynamic instability, etc). * allergy or contraindication to gadolinium. * contraindication to dual anti-platelet therapy.

Keywords: st segment elevation myocardial infarction failed thrombolysis rescue percutaneous coronary intervention cardiac magnetic resonance imaging
resistance profile of escherichia coli in infections of community origin: the importance of antimicrobial stewardship

Conditions: Antimicrobial Resistance

Summary: the main objective of the study is to describe the antimicrobial resistance profile of e. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit.

background: the growing antimicrobial resistance in bacterial pathogens represents a severe public health problem. isolation of escherichia coli esbl has been identified more frequently over the years due to the worldwide dissemination of strains with this phenotypic profile. the icu has a fully functioning antimicrobial stewardship team, with data managed daily. thus, the investigators identified increasing e. coli esbl isolates resistant to standard empiric antimicrobial therapy in community-based severe infections. purpose: the choice of empirical antimicrobial therapy is an increasingly present challenge in clinical practice, often determining the outcome of critically ill patients. as this is a highly relevant topic in managing this patient profile, antimicrobial stewardship protocols are essential in health services, enabling continuous community monitoring of emerging resistance profiles. the justification for this study is based on the possibility of adding knowledge on the topic, aiming to add to the global theoretical collection and alert about the locoregional occurrence of changes in the bacterial resistance profile. objectives: the main objective of the study is to describe the antimicrobial resistance profile of e. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the icu.

Eligibility criteria:
inclusion criteria: * all 18 years and old patients admitted to the icu * positive cultures for e. coli * any sample collected within 48 hours of hospital admission exclusion criteria: * lack of necessary data

Keywords: antimicrobial resistance escherichia coli esbl antimicrobial stewardship community infections
randomized controlled trial to test the efficacy of motivational interviewing on self-care

Conditions: Heart Failure

Summary: introduction: heart failure (hf) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. self-care is a cornerstone approach for optimizing therapy for patients with hf; patients play a key role in the management of their condition, given that several negative health outcomes might be avoided with effective self-care. motivational interviewing (mi) has been described by the literature as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with hf. methods and analysis: this study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial for purposing the aims to test the efficacy of a structured program including scheduled mi interventions in improving self-care behaviors among patients with hf at 3, 6, 9, and 12 months from the enrolment. secondary aims comprehend the corroboration of the superiority of caregivers' participation to the structured program including scheduled mi interventions over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes. analyses will be performed within the framework of intention-to-treat (itt). comparisons between groups will be based on an alpha = 5% and two-tailed null hypotheses. in the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods. ethics and dissemination: the study protocol and template consent forms have been reviewed and approved by the ethical committee of san raffaele hospital (approval #74/int). also, the study protocol has been registered at clinicaltrials.gov (identifier: .......). patients and caregivers will have to sign the informed consent forms before the randomisation. patients and caregivers may leave the study at any time. the withdrawal from the study will not imply any prejudice, as fully documented and explained in the informed consent. considering the open-access publication, the full protocol will be available freely.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * diagnosis of hf with new york heart association (nyha) class ii-iv; * no acute coronary events within three months; * consent to participate in the study; * score ≤ 2 to at least two items of the self-care of heart failure index 6.2 - schfi 6.2 at baseline; * score on six item screener \> 4; * living at home; * understanding of spoken and written italian. exclusion criteria: * severe cognitive impairment (score 0-4 on the six-item screener); * acute coronary events that occurred within three months; * living in nursing homes or residential settings; * caregivers unwilling to participate in the study.

Keywords: heart failure motivational interviewing self-care
a post authorisation registry of imnovid (pomalidomide) for patients with relapsed and refractory multiple myeloma.

Conditions: Multiple Myeloma

Summary: this registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take imnovid (pomalidomide) as part of standard care. the registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. all patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. during this time the incidence of second primary malignancies (spm), overall survival and any occurrence of a pregnancy will be assessed.


Eligibility criteria:
inclusion criteria: understand and voluntarily sign an informed consent form, if applicable, and have never been previously treated with pomalidomide before their inclusion in the registry. patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment. exclusion criteria: refusal to participate in the registry or currently participating in the treatment phase of an interventional clinical trial. pregnancy. women of childbearing potential, unless all the conditions of the pregnancy prevention program are met. male patients unable to follow or comply with the required contraceptive measures. hypersensitivity to the active substance or to any of the excipients.

Keywords: pomalidomide multiple myeloma relapsed, refractory observational imnovid registry post-approval safety