Kornimate/medical-research-clean huggingface dataset:
study to confirm of the safety and tolerability of brincidofovir in subjects with bk virus infection (viremia) after kidney transplantation

Conditions: BK Virus Infection; Nephropathy; Kidney Transplantation

Summary: this is a phase ii, multicenter, open-label, randomized, standard of care (soc) controlled, multiple ascending dose study to assess the safety and tolerability of iv brincidofovir (bcv) in subjects with bkv infection after kidney transplantation. the study will be conducted at multiple study sites in several countries including australia and japan. subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to bcv or soc (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the dose escalation phase and the expansion phase.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age at the time of signing the informed consent at screening. * kidney transplant recipient. "bk viral load increase and ≥ 3.6 log iu/ml" at 2 weeks post immunosuppression reduction or "bk viral load does not decrease by ≥ 0.3 log iu/ml" at 4 weeks post immunosuppression reduction during prescreening. (note: immunosuppressant reduction needs to be continued during the screening period). * egfr ≥ 30 ml/min. * subjects under immunosuppression with tacrolimus, mmf/myfortic, and/or corticosteroid. exclusion criteria: * subjects who weigh ≥ 120 kg. * national institutes of health/nci ctcae grade 2 or higher diarrhea (ie, increase of ≥ 4 stools per day over usual pretransplant stool output) within 7 days before day 1. * poor clinical prognosis, including active malignancy or use of vasopressors other than low dose (eg, ≤ 5 μg/kg/min) dopamine for renal perfusion within 7 days before day 1. * use of renal replacement therapy within 7 days before day 1. * history of intolerance to cidofovir or related compounds (ie, other nucleotide derivatives \[adefovir or tenofovir\])

Keywords: bk virus nephropathy kidney transplantation
dendritic cells-derived exosomes in human sepsis

Conditions: Sepsis

Summary: the amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. the primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.

this is a prospective, single-centered, clinical cohort study.

Eligibility criteria:
inclusion criteria: * patients were selected with the diagnostic standard "sepsis 3.0". * healthy volunteers do not have serious illness. exclusion criteria: * patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent. * patients give up treatments. * patients or volunteers withdrew from the study.

Keywords: sepsis exosomes dendritic cell
effect of ezetimibe treatment on low-density lipoprotein cholesterol (ldl-c) levels in participants with coronary heart disease (chd) already treated with a statin (mk-0653a-205 am1)

Conditions: Hypercholesterolemia

Summary: this non-interventional longitudinal study is a follow-up of the austrian cholesterol screening and treatment project (act i), which assessed the cholesterol status, including achievement of the target levels applicable at that time (ldl levels \<100 mg/dl), in participants with coronary heart disease (chd) already being treated with a statin. in this study, participants without adequate ldl-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.


Eligibility criteria:
inclusion criteria: * participants in whom ldl-cholesterol target levels have not been achieved. * participants in whom a decision has been made by the physician to initiate treatment with ezetimibe (longitudinal analyses). the treatment decision will be made prior to and independent from inclusion of participants into this study. - participants with ldl cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented. exclusion criteria: * any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe. * in order not to interfere with data collection it is recommended not to include participants currently in a clinical trial. * previous and ongoing treatment with ezetimibe.
evaluate the safety and efficacy of intrathecal injection of rjk002 in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis Als

Summary: the goal of the study aims to evaluate the safety and tolerability of a single intrathecal injection of rjk002 in subjects with amyotrophic lateral sclerosis (als), and to determine the recommended phase ii dose (rp2d).


Eligibility criteria:
main inclusion criteria: 1. female or male subjects who are ≥ 18 years of age at screening; 2. patients with a diagnosis consistent with clinically or laboratory-supported possible, probable, or definite sporadic or familial alsals in accordance with revised ei escorial diagnostic criteria published by the world federation of neurology (wfn); 3. the duration of the disease from the first symptom (any als symptom) prior to the screening visit must be less than 2 years (inclusive); 4. the amyotrophic lateral sclerosis functional rating scale-revised (alsfrs-r) score ≥30 during the screening period, and the three respiratory scores (dyspnea, upright respiration, and respiratory insufficiency) must be ≥3; 5. the forced vital capacity (fvc) of predicted during the screening period is ≥70% at screening; 6. body mass index (bmi) greater than 18 kg/m2 at screening; main exclusion criteria: 1. subjects with other neurological diseases similar to als that affect the evaluation of drug efficacy, such as cervical spondylotic myelopathy, syringomyelia, spinal cord and brain stem tumors, hirayama disease, multifocal motor neuropathy, multiple sclerosis, guillain-barre syndrome, parkinson's disease and dementia; 2. patients with a diagnosis consistent with clinically or laboratory-supported possible, probable, or definite sporadic or familial alsals in accordance with revised ei escorial diagnostic criteria published by the world federation of neurology (wfn); 3. subjects who refuse to take food and medication by nasal feeding tube during the study period due to swallowing dysfunction;
effect of acute nitrate supplementation on vascular function in hispanic, black and white population

Conditions: Healthy Adults

Summary: the purpose of the study is to assess vascular function in african americans, hispanic and caucasian americans to better understand racial differences in cardiovascular health. the investigators will further investigate the affect of beetroot juice on the vascular function of all participants.

african americans and hispanic individuals have the highest incidence of type 2 diabetes, which increases their risk of all cardiovascular diseases. one of the hallmarks of type 2 diabetes is vascular dysfunction, caused by a lack of nitric oxide bioavailability. vascular function and blood flow responses to exercise have been shown to improve after nitrate supplementation (beetroot juice), however, whether nitrate supplementation will improve vascular function in african american and hispanic individuals remains unknown. the investigators will perform a randomized, placebo-controlled study in healthy african american, hispanic and caucasian subjects. they will be studied before and 90 minutes after consuming beetroot juice (high nitrate supplement) or placebo, with at least 1-week washout period between the two visits (kenjale aa et al., j appl physiol 2011).

Eligibility criteria:
inclusion criteria: * healthy men and women who are either caucasian american, hispanic, or non-hispanic african american exclusion criteria: * blood pressure higher than or equal to 140/90 mmhg * bmi \> 35kg/m2 * have a history of cardiovascular, neurological or vascular diseases * take prescription medications * are smokers * are pregnant
treatment for opioid dependent offenders

Conditions: Opioid Dependence

Summary: this pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: drug court and the treatment alternative program (tap) in dane county. the questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.


Eligibility criteria:
inclusion criteria: * diagnosis of opioid dependence * opioid positive urine drug screen * participation in local drug treatment court or treatment alternative program * women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study exclusion criteria: * current alcohol or sedative dependence * pregnancy * women who are currently breast-feeding * complex psychiatric co-morbidity (e.g. suicidality, psychosis) * complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease) * current pharmacotherapy with an agent which is contraindicated in combination with suboxone or methadone according to drug labeling * paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or copd, end-stage renal disease, or severe morbid obesity

Keywords: opioid dependent methadone suboxone buprenorphine
different endurance training protocols in cardiac patients

Conditions: Coronary Artery Disease

Summary: it is the aim of our study to compare the effects of 6 and/or 2 years of either hit (carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients.

the three exercise arms (isocaloric) are composed as follows: endurance training: 31 min at 65-75% hrmax, making it a total of 25min; hit: 4x4min intervals at 85-95% hrmax divided by 3x3min of active recovery at 60-70% hrmax, making it a total of 25 min; pyramid: one pyramid consists of 8 one-minute blocks. those are grouped starting with one block of 70-75% hrmax, followed by one block at 75-80% hrmax and another one at 80-85% hrmax. the top of the pyramid are 2 blocks of 85-90% hrmax. intensity is lowered afterwards with one block of 80-85% hrmax, followed by one block at 75-80% hrmax and last one at 70-75% hrmax. two more pyramids follow, each divided by 2min of active recovery at 65-70% hrmax, making it a total of 28min. all protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% hrmax. primary outcome: individual maximum power output in watt (pmax). secondary outcome: change of power output in watt at lactate tresholds at 2 and 4mmol/l.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome (stemi - nonstemi) * aortocoronary bypass surgery * percutaneous coronary intervention (pci) * state after stable coronary heart disease * state after heart surgeries * state after myo-, endo-, or pericarditis * state after heart- or lung-transplantation * state after heart failure * state after pulmonary hypertension * state after peripheral venous disease * state after electrophysiological surgery * state after implantation of an implantable cardioverter or difibrillator * patients at high risk * patients with cardiac dysrhythmias or sudden death exclusion criteria: * unstable angina pectoris * heart failure (nyha iv) * acute myo-, endo-, or pericarditis or other infections * pulmonary-arterial embolism or phlebothrombosis within 6 months * hemodynamic instable dysrhythmias * hypertrophic cardiomyopathy * medical conditions which prevent patients from complying with the exercise program

Keywords: training protocol cardiac rehabilitation high-intensity interval training continuous training pyramid training physical performance
music in the emergency department (ed): phase ii

Conditions: Music Therapy; Patient Satisfaction

Summary: the investigators will conduct a prospective quasi-experimental design study of patients in the university of florida health emergency department. live preferential music will be performed for patients in the emergency department on alternating days over 20 weeks, and subjects exposed to the music intervention will be matched to a cohort that present to the emergency department on days with no music to assess impact on patient and healthcare provider satisfaction, pain medication utilization, length of stay, and cost of care.

every year, over 130 million patients access emergency care in the us. emergency departments are high stress environments and are one of the significant drivers of high costs in healthcare. the prevalence of anxiety experienced by patients in the emergency department (ed) is abundant and substantial. anxiety negatively affects the patient, the ed healthcare environment, and ed healthcare staff. additionally, anxiety routinely results in the administration of medication that would be otherwise unnecessary, and contributes to the overall cost of healthcare and the stress of clinicians, particularly nursing staff. the university of florida (uf) department of emergency medicine, in partnership with the uf center for arts in medicine, has recently completed phase one, and is proposing phase two, of a three-phase study to assess the impact of live preferential music on emergency department operations, including pain medication utilization and cost of care. the investigators propose to expand on the phase one pilot study to conduct a full randomized controlled study utilizing a group of highly talented musicians to provide live preferential music in our ed and level one trauma center setting. the project, the first systematic investigation of its kind, seeks to demonstrate that live preferential music in an emergency and trauma care setting can positively impact quality and cost of care.

Eligibility criteria:
inclusion criteria: * language: english * cognitive skill/education: grade 2 reading level or above exclusion criteria: * language: non-english speaking * age: less than 18 * cognitive skill/education: lower than grade 2 reading level

Keywords: emergency service, hospital
the parkinson's genetic research study

Conditions: Parkinson's Disease

Summary: the parkinson's genetic research study (pager), headed by dr. cyrus zabetian, is searching for genes that increase the risk of developing parkinson's disease (pd) and related disorders. the study is a joint effort by neurologists and researchers across the united states and is sponsored by the national institutes of health. the coordinating center for pager is located at the university of washington and the va puget sound health care system in seattle.

pager is focusing on families in which two or more people have been diagnosed with pd. past research suggests that such "multiplex" families might hold the key to the discovery of new pd genes. to take part in pager, participants will be asked to complete a questionnaire and to undergo an interview, a neurological exam, a short memory test, and a blood draw. enrollment in the study usually takes between one and two hours. there is no cost to participate, and all study information is kept strictly confidential. there are a number of designated sites across the country where families can enroll. however, for family members who are unable to travel to one of these sites, other arrangements can be made.

Eligibility criteria:
inclusion criteria: * over 18 years of age * member of a family in which there are two or more living individuals who have been diagnosed with parkinson's disease exclusion criteria: * under 18 years of age

Keywords: parkinson's disease genetics family research hereditary neurodegenerative diseases
effects of intranasal nerve growth factor for traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: traumatic bain injury(tbi) remains a hidden epidemic involving individuals affected predominantly at a young age who in the most severe cases remain with permanent physical,psychological and cognitive deficits.this study will investigate the therapeutic effects of intranasal nerve growth factor(ngf) in tbi.

early ngf concentration in the cerebral spinal fluid(csf)correlates significantly with the severity of head injury, and ngf upregulation correlates with better neurologic outcomes and could be useful to obtain clinical and prognostic information in patients with serve tbi. however, the clinical use of ngf is difficulty associated with delivering them to the cns because of the existing of blood-brain barrier(bbb). intranasal delivery drug is a noninvasive and convenient novel method bypassing bbb, which results in targeting therapeutics to the cns rapidly. the proposed study is a randomized, double-blind, placebo-controlled trail of ngf, starting between 24 to 72 hours post tbi, continuing for 2 weeks.

Eligibility criteria:
inclusion criteria: moderate to severe blunt traumatic brain injury defined as glasgow coma scale(gcs) between 7 and 13. age 18\~65 years. admission to jinling hospital between 24 to 72 hours. subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf. exclusion criteria: skull fracture, cerebrospinal fluid rhinorrhea. severe concurrent illness with life expectancy\<6 months or other serious illness which have a major impact on the outcome. treatment with other investigational agents in the past 4 weeks. allergy to ngf. primary ciliary dyskinesia, asthma, cystic fibrosis, viral and bacterial infections, diabetes mellitus. inability to provide informed consent. pregnancy or breast-breeding. women of childbearing age will be given a pregnancy test during screening to exclude pregnancy. -

Keywords: nerve growth factor traumatic brain injury intranasal prognosis neurological function
rare tumor case review

Conditions: Intrapericardial Teratoma Tumor; Tumors

Summary: the purpose of this study is to do a literature review and combine all of the cases of the intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor in children.

we excised an intrapericardial teratoma tumor out of a child approximately one month ago. this is a very uncommon tumor overall, and even more uncommon in children. the majority of reports in the literature are single case reports i would like to report ours, as well as do a literature review to combine all of the cases and see if some conclusions can be made about this rare tumor in children.

Eligibility criteria:
inclusion criteria: * children with intrapericardial teratoma tumors

Keywords: pediatric health rare tumor children cardiac
advanced development of desorption electrospray ionization mass spectrometry for intraoperative molecular diagnosis of brain cancer using pathology biopsies

Conditions: Glioma

Summary: this study explores whether desi-ms can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery.

primary objectives: i. to explore the translational abilities of desorption electrospray ionization mass spectrometry (desi-ms) as intraoperative diagnostic tool to: ia. identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of n-acetylaspartate (naa) and aberrations of the phospholipid signature of neurological tissue; ib. identify the presence of idh mutations by monitoring the 2-hydroxyglutarate (2hg) and therefore differentiate between idh-mutant and wild-type gliomas. outline: this is an observational study. patients undergo tissue sample collection and desi-ms during standard of care surgery and have their medical records reviewed on study. patients also undergo mri per standard of care on study.

Eligibility criteria:
inclusion criteria: * male and female patients age 18 and older * patients or their legally authorized representative (lar) able to provide written consent * schedule to undergo tumor resection exclusion criteria: * pregnant women
attitude and practice of egyptian dental practitioners regarding restoration repair

Conditions: Practice; Attitude; Dental Restoration Repair

Summary: this is a cross-sectional study with an aim to evaluate the variations in self-reporting attitude and practice of restoration repair among egyptian dental practitioners utilizing a survey questionnaire. it is undeniable that "minimally invasive dentistry" nowadays offers solutions to prolong the longevity of resin composite restoration with adhesive technology. due to the limited lifespan of dental restorations, defects are more prone to occur in the existing restorations and thus require dental treatment. it was stated in the literature that repairing could offer better advantages even though replacement of a restoration is a more common choice by many clinicians. since the concept of preserving tooth structure nowadays plays a major part in dental practice, invistigators need to understand where egyptian dental practitioners stand in understanding and applying the concept of restoration repair. assessment of knowledge and the missing data regarding the concept of repair that dentists in egypt have could help understand their awareness in applying conservatism in daily practice. there were some research about knowledge, attitude and practice of restoration repair in of dental practitioners in other countries, but little was known in egypt.


Eligibility criteria:
inclusion criteria: * egyptian dental practitioners that have completed their bachelor's degree, internship, have practice license and registered in the egyptian dental syndicate. exclusion criteria: * undergraduate dental students * dental practitioners that are still in internship * dental practitioners that don't have their practice license yet. * dental practitioners that are not registered in the egyptian dental syndicate.