Kornimate/medical-research-clean huggingface dataset:
using the xbox kinect for chronic tbi

Conditions: Traumatic Brain Injury

Summary: this study will evaluate the potential for improving balance for a single individual with a history of traumatic brain injury (tbi). the participant will engage in supervised therapy using commercial games on the xbox kinect. this study will also evaluate the viability of improving cardiovascular fitness using this intervention as well. the investigators hypothesize that balance improvements will occur and that using the xbox kinect is a viable way of improving cardiovascular fitness.

various forms of virtual reality (vr) training have been recently used for rehabilitation of neurological impairments including postural stability and coordination. virtual reality training has also been shown to increase motivation and attention through its use of novel goal-directed challenges. the xbox kinect gaming system allows the veteran to perform challenging full-body and goal-oriented activities. balance improvements using laboratory developed games have been demonstrated in those with a history of tbi. however, the investigators are specifically interested if improvements can be made using commercial games which can be utilized in physical therapy clinics more readily. exercise gaming has been shown to provide adequate intensity exercise to improve heart health in the healthy population. however, such benefits have not yet been investigated using the xbox kinect for individuals with a history of tbi.

Eligibility criteria:
inclusion criteria: * a male or female veteran participant must have sustained traumatic brain injury greater than 1 year prior to baseline assessments * veteran will be between the ages of 18 and 65 years old exclusion criteria: * veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension) * if veteran has a significant cardiac history (as defined by american college of sports medicine), physician approval will be acquired prior to cardiac stress tests * veterans with a previous history of behavioral impairments (e.g., aggression or inappropriate actions) that would preclude participation in standard physical therapy * veterans with lower extremity amputation * veterans that exhibit greater than mild cognitive impairments as shown by a score 17/30 or less on the montreal cognitive assessment (moca). * veterans that are unable to stand unsupported for at least 2 minutes * veterans that are unable to ambulate on treadmill with bilateral hand support

Keywords: traumatic brain injury virtual reality xbox kinect balance
the effects of familiar toy and parental presence combination on perioperative pediatric anxiety

Conditions: Perioperative Anxiety; Emergence Delirium

Summary: this study will evaluate the effect of presence of favorite toy and parent during perioperative period on pediatric anxiety and emergence delirium. half of the patients patients will be accompanied with their ownselected parent and the other half will be accompanied with their favorite toy in addition to their own selected parent.

to reduce the incidence of preoperative anxiety in children, anesthesiologists have used a number of prevention strategies, including sedative premedication, parental presence during anesthetic induction, behavioral preparation programs, music therapy, hypnosis, and acupuncture.one of these distraction tool is familiar toy, children may also be comforted by familiar toys. therefore, parent presence during perioperative period or playing with a favorite toy seems likely to alleviate preoperative anxiety in children. until now, combination of these two method to reduce anxiety is not observed in literature. then, the aim of this observational study is to evaluate the effect of both presence of favorite toy and parental presence compare to only parental presence during perioperative period on anxiety and emergence delirium in patients undergoing ambulatory surgery in our hospital's otorhinolaryngology department.

Eligibility criteria:
inclusion criteria: patients with asa 1 and 2, those who have the ability to speak and obey commands will be included. exclusion criteria: mentally challenged deaf child cerebral palsy premedicated child language problem unco-operative previous surgery or anesthesia history

Keywords: anxiety state familiar toy child behavior
study evaluating tigecycline in selected serious infections due to resistant gram-negative organisms

Conditions: Gram-Negative Bacterial Infections

Summary: to evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, acinetobacter baumannii, enterobacter species, klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. the primary efficacy endpoint will be the clinical response.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 years or older * isolation of a resistant gram-negative pathogen, eg, enterobacter species, acinetobacter baumannii, klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate of a polymicrobial infection * resistant gram-negative organisms are defined by the likely presence of esbl or related mechanisms which limit the therapeutic alternatives for the treatment of complicated infections exclusion criteria: * subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study * anticipated length of antibiotic therapy \< 7 days * known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)

Keywords: bacterial infections
deferoxamine for the prevention of cardiac surgery-associated acute kidney injury

Conditions: Acute Kidney Injury

Summary: multiple lines of evidence support a central role of iron in causing acute kidney injury (aki), including the finding that prophylactic administration of iron chelators attenuates aki in animal models. patients undergoing cardiac surgery may be particularly susceptible to iron-mediated kidney injury due to the profound hemolysis that often occurs from cardiopulmonary bypass. the investigators will test in a phase 2, randomized, double-blind, placebo-controlled trial whether prophylactic administration of deferoxamine decreases the incidence of aki following cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. undergoing coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass 3. aki risk score ≥6 at the time of screening 4. written informed consent from the patient or surrogate exclusion criteria: 1. aki, defined as any of the following: * increase in serum creatinine ≥0.3 mg/dl in 48h * increase in serum creatinine ≥50% in 7d (if no value available in last 7d, use most recent value in last 3 months) * urine output ≤0.5 ml/kg/h x 6 consecutive hours (only assessed in patients with hourly monitoring via foley catheter) * receipt of renal replacement therapy (rrt) within 7d 2. advanced chronic kidney disease (egfr \<15 ml/min/1.73m2 or end-stage kidney disease receiving rrt) 3. hemoglobin \<8 g/dl (closest value in the prior 3 months) 4. fever (temperature ≥38⁰c) in the last 48h 5. suspected or confirmed bacteremia, endocarditis, or pyelonephritis 6. pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious etiology reported on chest x-ray or ct scan in the last 7d 7. positive covid-19 test within previous 10d 8. chronic iron overload (including conditions such as hemochromatosis and beta thalassemia major) or previous iron chelation therapy (including prior participation in defeat-aki) 9. known hypersensitivity to deferoxamine 10. taking prochlorperazine 11. severe hearing loss 12. pregnant or breastfeeding 13. prisoner 14. concurrent participation in another interventional research study in which the intervention has potential interaction with deferoxamine 15. surgery to be performed under conditions of circulatory arrest 16. receiving extracorporeal membrane oxygenation 17. durable ventricular assist device (vad) prior to surgery (does not include impella device or intra-aortic balloon pump) 18. any condition which, in the judgement of the investigator, might increase the risk to the patient 19. conflict with other research studies
stimulant use and methylation in hiv

Conditions: HIV Infections; Methamphetamine-dependence; Methamphetamine Abuse

Summary: this study will leverage extracted leukocyte dna specimens from a completed nih-funded project to examine the efficacy of a behavioral intervention model that reduced stimulant use on dna methylation over 6 months.


Eligibility criteria:
inclusion criteria: * at least 18 years old * documentation of hiv-positive serostatus * speak english * biological verification of recent methamphetamine use * completion of at least three contingency management (cm) visits * self reported anal sex with a man in the past 12 months exclusion criteria: * inability to provide informed consent, evidenced by cognitive impairment * hiv negative serostatus

Keywords: hiv methamphetamine methylation
comparison of holter vs s-patch for arrhythmia detection in older falls patient

Conditions: Bradyarrhythmia; Arrythmia

Summary: the aim of this study is to compare holter versus s patch in a group of elderly patients who are referred to the geriatrics service in changi general hospital for falls from accident and emergency department, clinic and wards. the investigator hope to assess the feasibility, adherence and patient acceptability as an alternative to holter monitoring. the investigator also hope to learn if s-patch ex monitoring system can be as effective or equivalent to holter in the monitoring of arrhythmias and the possibility of deploying it for longer term monitoring of arrhythmias. participants who consented to be in this study will be offered s patch and holter consecutively. holter will be worn for 24 hours and s patch will be worn for 72 hours. the order which holter or s patch will be worn first will be determined via randomisation.


Eligibility criteria:
inclusion criteria: 1. aged 60 to 120 year old inclusive 2. refer for holter testing as part of clinical care 3. participants with symptoms suspected to be due to bradyarrhythmia. this could include, but not limited to unwitnessed fall, syncope, near syncope. exclusion criteria: 1. participants who are already known to have significant bradyarrhythmia who would benefit from a permanent pacemaker. 2. patients unable to tolerate holter monitoring.
a clinical trial to evaluate the efficacy and safety of ckd-495

Conditions: Gastritis

Summary: to evaluate the efficacy and safety of ckd-495

a phase 3, multi-center, randomized, double-blind, parallel-group trial to evaluate the efficacy and safety of ckd-495 in patients with acute and chronic gastritis

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥ 19 2. acute or chronic gastritis patients who have more than 1 erosion on endoscopy within 7days prior to the use of the investigator's product taken date 3. patients who have more than 1 subjective symptom exclusion criteria: 1. patients with peptic ulcer, gastroesophageal reflux disease, malignant tumor in the digestive system or coagulation disorder, or taking antithrombotic medicine 2. patients who have been taken any gastritis medicine that could affect the treatment: h2 receptor antagonist, ppi(proton pump inhibitor), antacid, improvement of movement in digestive system, prostaglandin, and protective agent for gastritis 3. patients who have to take medicine that could cause gastritis

Keywords: acute gastritis chronic gastritis cinnamic acid ckd-495
infliximab biosimilar for intravenous drip infusion 100 mg "pfizer" drug use investigation (psoriasis)

Conditions: Psoriasis Vulgaris; Psoriasis Arthropathica; Pustular Psoriasis; Erythrodermic Psoriasis

Summary: to collect information on the safety and effectiveness of infliximab bs for intravenous drip infusion 100 mg "pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.

this study will be conducted with all-case investigation system in patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis. this study will be conducted in patients who used this drug after the day of approval of dosage and administration for psoriasis at contracted medical institutions. patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included). therefore, time perspective is retrospective and prospective.

Eligibility criteria:
inclusion criteria: * patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who started treatment with this drug * patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Keywords: infliximab biosimilar
a study to assess the effect of danicamtiv on the drug levels of midazolam in participants with stable heart failure

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this study is assess the effect of danicamtiv, as an inducer on the drug levels of midazolam in participants with heart failure with reduced ejection fraction (hfref).


Eligibility criteria:
inclusion criteria: * ambulatory participants with stable hfref due to any etiology. * body mass index (bmi) of 18.0 kilogram per square meter (kg/m2) to 35.0 kg/m2 inclusive. * documented left ventricular ejection fraction (lvef) 15% to 45% (on 2 occasions), including at least once during screening and confirmed by the echo core laboratory (the absolute difference between the 2 lvef values qualifying the participant should be \< 12%). * participant receiving chronic medication for the treatment of heart failure reflecting current guidelines, including at least one of the following, unless not tolerated or contraindicated:β-blocker, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, or angiotensin receptor neprilysin inhibitor. such treatments should have been given at stable doses for at least ≥ 2 weeks prior to screening with no plan to modify treatments during the study. * sinus rhythm or stable atrial or ventricular pacing or persistent atrial fibrillation that is adequately rate-controlled to allow pharmacodynamic (pd) assessments by transthoracic echocardiogram (tte). note: participants with implanted cardioverter defibrillator (icd), pacing, or cardiac resynchronization therapy are eligible provided device programming is unchanged starting 2 months prior to and throughout the dosing period. * adequate acoustic windows, determined by the echo core laboratory, to enable accurate tte assessments. exclusion criteria: * presence of disqualifying cardiac rhythms that would preclude echocardiographic assessments, as determined by the investigator, including: (a) rapid, inadequately rate controlled atrial fibrillation or (b) frequent premature ventricular contractions that might interfere with reliable echocardiographic measurements of left ventricular function. * history of bronchospasm, or history of respiratory depression or arrest, airway obstruction, oxygen desaturation, or apnea. * history of allergy to midazolam, other benzodiazepines, danicamtiv, related compounds, or excipients in the formulations. * severe renal insufficiency (defined as current estimated glomerular filtration rate \[egfr\] \< 30 ml/min/1.73 m2 by simplified modification of diet in renal disease equation \[smdrd\].

Keywords: hfref danicamtiv bms-986434 myk-491 midazolam
study of phenoptin in subjects with phenylketonuria who participated in protocols pku-004 or pku-006

Conditions: Phenylketonuria

Summary: the objective of this study is to evaluate the safety of long-term treatment with phenoptin in subjects with phenylketonuria (pku) who participated in phase 3 clinical studies with phenoptin.


Eligibility criteria:
inclusion criteria: * participation in study pku-004 or pku-006 * willing and able to provide written, signed informed consent or, in the case of subjects under the age of 18 years, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained, and prior to any research-related procedures * negative urine pregnancy test at screening (females of child-bearing potential) * willing and able to comply with all study procedures exclusion criteria: * non-responsive to prior treatment with phenoptin based on participation in pku-004 or pku-006 * perceived to be unreliable or unavailable for study participation or, if under the age of 18 years, have parents or legal guardians who are perceived to be unreliable or unavailable * terminated early from pku-004 or pku-006, except for subjects in pku-004 that rolled into pku-008 at week 22, subjects in pku-006 that rolled into pku-008 at week 10, or subjects in pku-006 that terminated due to elevated phe levels following dietary phe increases * use of any investigational product other than phenoptin within 30 days prior to screening, or anticipated requirement for any investigational agent prior to completion of all scheduled study assessments * positive urine pregnancy test at screening (non-sterile females of child-bearing potential only), already known to be pregnant or breastfeeding or planning a pregnancy in self or partner during the study * female subjects of childbearing potential must be using an effective method of birth control, as determined by the pi, and willing to continue to use acceptable birth control measures * concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes) * any condition that, in the view of the pi, renders the subject at high risk from treatment compliance and/or completing the study * alt \> 2 times the upper limit of normal (i.e., grade 1 or higher based on world health organization toxicity criteria) at screening (see appendix 2) * serious neuropsychiatric illness (e.g., major depression) not currently under medical control * prior history of organ transplantation * requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate) * concurrent use of levodopa * clinical diagnosis of primary bh4 deficiency

Keywords: pku
local and widespread hypoalgesic effects of neurodynamic mobilization in healthy controls

Conditions: Pain; Pain, Neuropathic

Summary: background \& significance pain is the primary reason many patients seek care from healthcare professionals who utilize various manual therapy techniques. gaining further understanding of the hypoalgesic properties of such techniques can enable practitioners to more skillfully integrate them in managing patients presenting with pain. previous research has revealed that various manual techniques result in both local and widespread hypoalgesic changes in asymptomatic controls and patients in pain. much of this previous research has investigated thrust manipulation; however, there is a paucity of similar research investigating these effects in neurodynamic mobilization. specific aims aim: to assess for immediate local and widespread hypoalgesic effects of neurodynamic mobilization applied to the upper extremity. hypotheses: * subjects who receive neurodynamic mobilizations will exhibit greater positive changes in local and widespread qualitative sensory testing (qst) measures compared to those who receive a sham mobilization. * subjects who receive neurodynamic mobilizations will exhibit greater positive changes in elbow rom and reported sensation intensity with upper limb neurodyndamic testing as compared to those who receive a sham mobilization. aim: to assess for differences in immediate local and widespread hypoalgesic effects of sliding vs tensioning neurodynamic mobilization techniques applied to the upper extremity hypotheses: * subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in local and widespread qst measures compared to those who receive tensioning neurodynamic mobilization * subjects who receive sliding neurodynamic mobilizations will exhibit greater positive changes in elbow range of motion (rom) and reported sensation intensity with upper limb neurodynamic testing testing compared to those who receive a tensioning neurodynamic mobilization

see protocol uploaded in documents section

Eligibility criteria:
inclusion criteria: * age: 18-65 * ability to speak and comprehend english. exclusion criteria: * current neck or upper extremity symptoms * disorders that could result in impaired sensation - such as diabetes. * current use of prescription pain medication or other medications that could result in altered pain perception - such as anti-anxiety medications or anti-depressants. * history of any chronic painful condition * diagnosis of any major psychiatric disorder * current pregnancy * any painful condition within the past 3 months for which care was sought

Keywords: neurodynamics neurodynamic mobilization quantitative sensory testing median nerve pressure pain threshold thermal pain threshold thermal pain tolerance
randomized trial of peer led education-project dulce

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income mexican-americans with type 2 diabetes using the project dulce model utilizing a low cost, peer-educator format.

to recruit 207 mexican-americans patients from federally-funded community health centers in san diego county with hemoglobin a1c (hba1c) \> 8% and randomize to project dulce peer intervention or continuation of standard diabetes care. the primary outcome will be the percent change in hba1c levels at 10 months following randomization.

Eligibility criteria:
inclusion criteria: * mexican american, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in san diego county with type 2 diabetes and hba1c \> or = 8%. exclusion criteria: * individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, hba1c \< 8,pregnant with gestational diabetes

Keywords: peer education diabetes randomized trial
vivo european observational registry

Conditions: Ventricular Arrythmia; Ventricular Tachycardia; Premature Ventricular Contraction

Summary: a multi-center, observational registry conducted in europe and the uk to prospectively review vivo in a clinical setting in 125 patients.


Eligibility criteria:
inclusion criteria: * patients must at least 18 years of age patients who have signed an irb/ec approved patient informed consent and applicable patient privacy protection authorization per local law * patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care * patients will be selected without regard to gender. exclusion criteria: • patients that are unable to receive contrast cardiac imaging (mr or ct)