Kornimate/medical-research-clean huggingface dataset:
comparison of virtual reality and passive distraction on burn wound care pain in adolescents

Conditions: Burns; Wound Care; Pain

Summary: relief of severe burn wound care pain may require both medications to relieve pain and non-medication interventions,such as distraction. little is known about distraction's effectiveness. virtual reality may be an effective distraction. the aims of this study are 1)to evaluate the effect of virtual reality (vr), a newer interactive kind of distraction, compared to passive distraction (pd) by watching a movie, and usual care (sc) that is provided by the nurses, on pain experienced by adolescents during burn wound care and 2)to determine the relationship among anxiety, desire for distraction, and engagement with distraction on the pain.


Eligibility criteria:
inclusion criteria: * undergoing burn wound care in the arkansas children's hospital (ach) outpatient burn clinic; * first time visit to the ach outpatient burn clinic or first clinic visit without conscious sedation; * adolescents ages 10 to 17 years; * english speaking; * absence of a history of motion sickness (motion sickness has been reported in some vr users); * absence of a seizure disorder (because prolonged immersion in vr may lead to seizures and vertigo in individuals with seizure disorders, these individuals will be excluded from the study); * absence of a cognitive developmental disability determined on prescreening by presence of a section 504 accommodation plan or title viii individualized educational plan (iep) in school. if the parent identifies the nature of the iep or 504 plan as unrelated to a cognitive delay, then the child or adolescent will be included in the study. exclusion criteria: * burns that would interfere with study procedures * incarcerated minors * children in foster care

Keywords: pain anxiety children adolescents burn virtual reality distraction
a study of istradefylline (kw-6002) for the treatment of parkinson's disease in patients taking levodopa

Conditions: Parkinson's Disease

Summary: to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the percentage of off time in patients with advanced parkinson's disease (pd) treated with levodopa.

to establish the efficacy of 20 mg/d and 40mg/d doses of istradefylline for reducing the percentage of off time in patients with advanced parkinson's disease (pd) treated with levodopa. patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/d istradefylline or matching placebo. patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

Eligibility criteria:
inclusion criteria: 1. uk parkinson's disease society (ukpds) brain bank criteria (step 1 and 2) for pd. 2. pd stages 2-4 in the off state for modified hoehn and yahr scale. 3. on levodopa/dci for at least one year, stable dose in past 4 weeks. 4. currently take at least three doses of levodopa/dci per day. 5. predictable end of dose wearing off. 6. able to satisfactorily complete hauser version of a parkinson's diary. 7. have an average of 120 minutes of off time on two 24 hour diaries. 8. on a stable regimen of medications being administered within normal therapeutic limits for parkinson's disease for at least four weeks before randomization. 9. be at least 30 years of age. exclusion criteria: 1. neurosurgical treatment for pd. 2. history of psychosis. 3. diagnosis of atypical parkinsonism or secondary parkinsonism variant. 4. diagnosis of cancer within 5 years. 5. diagnosis of clinically significant illness of any organ system. 6. mini-mental status examination score of 25 or less. 7. taking any excluded medications. 8. history of drug or alcohol abuse or dependence within the past two years. 9. history of seizures or neurological malignant syndrome. 10. clinical depression. 11. pregnant or lactating females.

Keywords: parkinson's disease levodopa end of dose wearing off off time
effect of wf10 (tcdo) on hba1c values in diabetic foot ulcer patients

Conditions: Diabetic Foot Ulcer (DFU); Uncontrolled Diabetes With Foot Ulcer

Summary: study in adult diabetes mellitus patients with diabetic foot ulcers and elevated hba1c who will receive standard wound treatment in combination with adjuvant therapy wf10 to compare the change of hba1c levels at baseline and after treatment.

single-center, prospective open-labelled one group pretest posttest pilot study

Eligibility criteria:
inclusion criteria: * patients diagnosed with diabetes mellitus type ii * patient male or female 18-80 years old * presence of diabetic foot ulcer/non-healed stump, starting at least 3 weeks before or infected wound degree 3-4 * hba1c \> 8.5% * hematocrit \> 30% exclusion criteria: * kanofsky performance status \< 60 * patient with abi (ankle brachial index) \< 0.4 * patient who receive steroid ,chemotherapeutic drug * pregnant or lactating woman * patient had a history of organ transplantation, and using immunosuppressive drug * patient with end-stage renal disease requiring hemodialysis, or history of g6pd or severe thalassemia, or ischemic heart disease, congestive heart failure, heart arrhythmia * patient who is participating in another clinical study or have done it in the past 30 days.

Keywords: dfu wf10
pf-04634817 renal impairment study

Conditions: Renal Insufficiency

Summary: patients with renal impairment are the target population for pf-04634817. the clearance mechanism of this drug means that exposure may be increased in subjects with renal impairment. this study will investigate the effect of the drug in subjects with varying degrees of renal impairment. pharmacokinetics, safety and toleration will be assessed.


Eligibility criteria:
inclusion criteria: * male or female (non child bearing potential aged 18-75 years * documented renal impairment (mild, moderate or severe using cockcroft-gault equation) or matched healthy volunteers (age, weight and gender) exclusion criteria: * subjects with acute renal failure * subjects receiving, or likely to receive, cyp450 3a4 inhibitors * abnormal ecg at screening

Keywords: subjects with renal impairment healthy
intravenous versus subcutaneous administration of low molecular weight heparin for thromboprophylaxis in critically ill patients

Conditions: Critical Illness

Summary: objective: to compare the pharmacokinetic profiles of intravenous versus subcutaneous route of administration of lmwh for thromboprophylaxis in critically ill patients

the study is a prospective, monocentric, randomized trial. patients are randomized to the iv route of administration over a 4-hours infusion of nadroparin 3800 iu or to the sc route of administration. randomization is stratified according to the need for vasopressor or not. anti-xa activity is measured at baseline, and at 1, 2, 4, 6, 8, 12 and 24 hours after the administration was started.

Eligibility criteria:
inclusion criteria: * adults patients \> 18 years old admitted in the icu, and for whom thromboprophylaxis is indicated exclusion criteria: * renal failure determined by glomerular filtration rate (gfr) \< 30 ml/min or need for renal replacement therapy * liver cirrhosis * intravascular disseminated coagulation * contra-indication to thromboprophylaxis for any reason as decided by the treating physician, or indication for therapeutic dosing anticoagulation (recent thrombo-embolic event, atrial fibrillation,...) * patients receiving low dose of vasopressor (norepinephrine \< 0.25 mcg/kg/min) to allow stratification and comparison between patients not on vasopressors and patients with a significant dose of vasopressors (norepinephrine ≥ 0.25 mcg/kg/min)
dichotic listening as a predictor of medication response in depression

Conditions: Major Depressive Disorder; Dysthymia

Summary: this study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.

preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning , and do not show an advantage of drug over placebo. 100 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. preferential hemisphere for auditory processing will be correlated with treatment outcome.

Eligibility criteria:
inclusion criteria: 1. ages between 18-65 2. meets diagnostic and statistical manual, fourth edition (dsm-iv) criteria for current major depression, dysthymia or depression not otherwise specified exclusion criteria: 1. known hearing impairment 2. active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis). 3. hamilton rating scale for depression (hamd), 21-item total score \>20 4. current (past 6 months)alcohol and/or drug abuse or dependence 5. medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by imipramine) 6. bipolar i 7. psychosis 8. non-response to adequate trial of study medication (i.e., \> or = 4 weeks on \> or = bupropion 300mg/d, escitalopram 30mg/d, or imipramine 200mg/d) 9. premenopausal women not using known effective birth control 10. not currently depressed (whether considered due to current treatment or not) 11. history of seizure, seizure disorder, anorexia nervosa, or bulimia 12. left-handed -

Keywords: depression
compliance of antihypertensive treatment study (cat study)

Conditions: Hypertension

Summary: study rational: in general, chronic disease without symptoms such as hypertension, the treatment compliance is relative low and is difficult to increase. the low compliance is related to poor prognosis. there are many factors that effect to compliance of antihypertensive drug. education is one factor that can be controlled by doctors. therefore, in this study, the compliance of the patients in 3 groups of active training group, passive training group, and no training group (usual treatment group) will be compared to evaluate the effect of training for controlling of hypertension.

objectives: primary objective - the compliance of each group for the antihypertensive drug is evaluated and compared. the patients are allocated to three groups; active training group, passive training group, no training group (usual treatment group) and training is performed as described below. * active training group: electronic pill-boxes with sms service 1/week, training material provided * passive training group: electronic pill-boxes ,training material provided * usual treatment group: electronic pill-boxes, maintain current treatment method secondary objective - * evaluate other factor that has effect on the compliance of antihypertensive drug. * evaluate the blood pressure lowering effect according to the compliance of antihypertensive drug. * evaluate the percentage of missed doses, the percentage of delayed doses, the percentage of multiple doses. * evaluate the effect of education on the compliance of antihypertensive drug. timelines fpfv : jan, 2008 lplv: dec. 2008 methodology: this clinical trial is multi center, prospective, randomized, open, observational study. this study is to compare the compliance for antihypertensive drugs according to different method of patient training and the observation period per patient is 6 month. there is no fixed visit date and the visits are made according to patient's periodic treatment schedules. to come up with representative and reliable nation wide statistical data, from hospitals nation wide patient who receive drugs (ace-i, arb, β-blocker, ccb, diuretic) for blood pressure lowering purpose according to the prescription patterns of investigator will be registered. number of centers \& patients: no. of centers: 20 general hospitals no. of patients: 1,062 patients

Eligibility criteria:
inclusion criteria: * patient diagnosed as hypertension. * hypertension patients diagnosed and treated but not meeting the target blood pressure. (target blood pressure: sbp\<140mmhg and dbp\<90mmhg. in case having concomitant disease jnc-vii guideline is followed) * patients age over 18 exclusion criteria: * patients with severe chronic disease * patients scheduled for operation within 6 month period. * patients currently participating in other clinical study. * pregnant, nursing patient and patient with potential to be pregnant. * patient who can not or has no intension to participate in compliance check.

Keywords: blood pressure compliance treatment
influence of smoking on clinical, microbiological and immunologic parameters in patients with aggressive periodontitis.

Conditions: Periodontal Diseases; Aggressive Periodontitis

Summary: treatment of smoker patients with agp is considered a challenge to periodontists. to date, only one controlled clinical study (de genaro modanese et al., 2016) evaluated the effect of full mouth ultrasonic debridment (fmud) on smokers with aggressive periodontitis. its results showed significant improvements in clinical parameters (plaque index pi, bleeding on probing- bop and probing depth-pd), and immunologic (reductions in interleukin 6- il-6, tumor necrosis factor- α tnf-α levels), although the results were more favorable for non-smoking patients. antimicrobials associated to mechanical therapy has been extensively studied (hafajee et al., 2003, heitz-mayfield, 2006). the association of amoxicillin and metronidazole have had good clinical and microbiological results in randomized clinical trials in the treatment of agp (casarin et al., 2012, sgolastra et al., 2012, keestra et al., 2015). thus, this study investigates clinical, microbiological and immunological influence of smoking in the periodontal debridement associated to amoxiciclin and metronidazole of young individuals with pronounced periodontal destruction, compared with non-smokers individuals.


Eligibility criteria:
inclusion criteria: * diagnosis of generalized aggressive periodontitis, according to the american academy of periodontology-aap, 1999; * presence of at least 15 teeth; * presence of at least 6 teeth containing 6 deep sites (≥ 7 mm), which are not located in bifurcation areas and * present less than 20% of plaque index (pi) and bleeding on probing (bop). exclusion criteria: * presence of periapical or pulpar alteration; * presence of systemic alteration or use of medications (6 months prior to the study) that may influence the response to periodontal treatment; * pregnant and lactating women; * performing periodontal treatment including subgingival instrumentation in the 6 weeks preceding the study; * teeth with bifurcation involvement; * teeth with marked mobility; * oral pathology; * history of allergy to any component of the study, and * previous periodontal surgery in the region of interest.
long-term outcomes of critical illness survivors

Conditions: Intensive Care Units

Summary: the goal of this study is to assess the long-term outcomes of critical illness survivors,including physical, psychological, and cognitive sequelae.

an increasing number of patients survive critical illness; however, the evidence reveals that over the same period the number of patients being sent to rehabilitation settings have tripled . for those who do survive, the latest data indicate that 50-70% of icu "survivors" will suffer cognitive impairment and 60-80% of "survivors" will suffer functional impairment or icu-acquired weakness (icu-aw).still,there is a lack valid data on the long-term impact on morbidity from prospective observational studies. therefore, the investigators designed an observational cohort which cover a broader range of outcomes to quantify long-term physical, psychological, and cognitive impairment after intensive care unit (icu).intensive care unit patients survive from critical illness will be approached for study recruitment and participation.survival rate,quality of life,cognitive impairments,depression and anxiety,ptsd,physical activity,neuromuscular impairment will be assessed 3 or 6 months after icu discharge.

Eligibility criteria:
inclusion criteria: * patients aged \>17 years * patients in intensive care unit(icu) with at least one organ or system dysfunction,such as respiratory failure, cardiogenic shock,or septic shock. exclusion criteria: * refuse to participate * death before icu discharge * pre-existing cognitive impairment, malignant tumor
total ankle replacement versus arthrodesis trial

Conditions: Osteoarthritis

Summary: the purpose of tarva is to determine whether total ankle replacement (tar) provides better clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness of the two treatments

this is a randomised, multi-centre, non-blinded, prospective, parallel-group trial of tar versus ankle arthrodesis in patients with end-stage ankle osteoarthritis (oa) aged between 50 and 85 years, comparing clinical outcomes (pain-free function, quality of life (qol), range of motion (rom), and rate of post-procedural complications) and cost-effectiveness. tarva is a clinician-led, pragmatic, superiority trial designed to compare the improvement in pain-free function, as assessed by the manchester-oxford foot questionnaire (moxfq) walking/standing domain score from pre-op to 52 weeks post-op for each surgical treatment group. a total of 328 patients will be randomly allocated on an equal basis to one of two surgical treatments: i) total ankle replacement; and ii) ankle arthrodesis. randomisation will be stratified by surgeon and presence of oa in two adjacent joints as determined by a pre-operative mri scan.

Eligibility criteria:
inclusion criteria: * diagnosis of end-stage ankle osteoarthritis * aged 50-85 years inclusive * the surgeon believes the patient is suitable for both tar and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status) * the patient is able to read and understand the patient information sheet (pis) and trial procedures * the patient is willing and able to provide written informed consent exclusion criteria: * previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure * more than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions) * • unable to have mri/ct scan (e.g. severe claustrophobia or contraindication for either scan) * history of local bone or joint infection * any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety * participant in another clinical trial that would materially impact on their participation in this study

Keywords: ankle arthritis osteoarthritis total ankle replacement arthrodesis quality of life musculoskeletal
autologous cik cells infusion for the treatment of lung cancer: a randomized controlled study

Conditions: Lung Cancer

Summary: to study the efficacy and safety of autologous cik cells infusion for the treatment of lung cancer.

a randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (cik) cells infusion treatment in advanced primary lung cancer

Eligibility criteria:
inclusion criteria: * 18\~70 year old, kps score \>50 points, estimate survival \> 3 months; * primary lung cancer patients after chemotherapy or radiation therapy; * primary lung cancer patients after targeted therapy; * primary lung cancer patients with lung function can not accept operation or unwilling to operation; * primary lung cancer recurrence or surgery can't complete resection; * primary lung cancer patients after intervention therapy(i125 implanted, freezing, rf, etc.); * no serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases; * patients voluntary attempt, and informed consent. exclusion criteria: * history of cardiovascular disease: congestive heart failure \> new york heart association (nyha) level ii, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction; * cachexia; or other deadly diseases; * liver function laboratory alt, ast more than normal limits on 2.0 times ; or kidney tbil, bun more than normal limits on 1.0 times , or cr more than normal upper limit; * active infection; * pregnant or lactating women * at present is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents); * now or recently will join another experimental clinical study ; * other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, hiv infections, etc.), or influence on the results of clinical trials for analysis.

Keywords: lung cancer cik cells therapy
effects of short-term interventions for a healthy lifestyle on the human lipidome in subjects with metabolic syndrome

Conditions: Metabolic Syndrome; NAFLD; Obesity; Hypertension

Summary: a growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. however, data on this issue is still sparse and especially interventional data is not available up to now. "gesundleben" will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. standardized metabolic assessment will be covered with routine laboratory parameters and oral glucose tolerance test as well as non-radiologic anthropometric measurements.

a growing number of cross-sectional studies is investigated the role of the human lipidome as a new biomarker for metabolic diseases. however, data on this issue is still sparse and especially interventional data is not available up to now. we intend to clarify, if the human lipidome is correlating with metabolic state and if changes in this state reflect on the lipidome. using high-throughput shot-gun technique, we will be able to measure several hundreds of lipid species in one blood sample. the "gesundleben" trial will provide data on 100 human subjects with metabolic syndrome, undergoing distinct types of lifestyle intervention for 6 weeks. the cohort will be designed to include participants from both sexes, but be restricted on subjects without impaired glucose tolerance. standardized metabolic assessment will be covered with routine laboratory parameters (e.g. transaminases, hba1c) and oral glucose tolerance test as well as non-radiologic anthropometric measurements (bmi, whr, bia).

Eligibility criteria:
inclusion criteria: * hypertension * nafld * obesity * hyperuricemia * dyslipoproteinemia exclusion criteria: * prediabetes / overt diabetes mellitus * present cancer * systemic infection * chronic inflammatory disease * recent stroke / myocardial infarction (6 months) * pregnancy * addiction / severe psychiatric diseases