Kornimate/medical-research-clean huggingface dataset:
observational study to evaluate the actual use of elidel® in chinese patients with mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objective of the present multicentre, prospective, non-interventional study (nis) is gathering knowledge on the actual use and effectiveness of elidel® in chinese patients with mild to moderate ad affecting sensitive skin areas in routine clinical practice.


Eligibility criteria:
inclusion criteria: * patients of chinese ethnicity * patients at least 2 years old * signed informed consent from patient and if applicable from parent(s) or legal guardian(s) in compliance with local requirements * patients with mild to moderate ad and depending on the age: * patients 2-12 years must have: - scorad index \< 50 * patients 13 years and older must have: * affecting sensitive skin areas (e.g. face, intertriginous sites, anogenital area) * scorad index \< 50 and iga in sensitive skin areas ≤ 3 exclusion criteria: * patients for whom elidel® is not recommended accordingly to the package insert * patients with severe atopic dermatitis (scorad index ≥ 50 or iga in sensitive skin \> 3) * receiving systemic glucocorticoids, antibiotics, antifungals, immunomodulators, inhibitors, antihistamines and ultraviolet radiation therapy within the last 4 weeks before inclusion; * receiving any topical ad-effective drugs within the last 2 weeks before inclusion; * pregnant and/or breastfeeding women * patients or parent(s) / legal guardian (as applicable) that are not able to fulfil study requirements according to physician's opinion * patients or parent(s) / legal guardian (as applicable) that refuse to participate to the study
reliability and validity of patient reported outcome measures in head and neck cancer

Conditions: Shoulder Pain; Head and Neck Cancer

Summary: this study will utilize rasch analysis to study the construct validity and reliability of five shoulder-related patient-reported outcome measures in patients reporting shoulder impairment following surgery for head and neck cancer.

this study is a cross-sectional, questionnaire-based psychometric study. the purpose of the study is to: (1) use rasch methodology to assess the reliability, construct validity, and overall appropriateness of test score interpretation of 5 shoulder-related patient reported outcome measures in patients experiencing shoulder dysfunction following neck dissection surgery for head and neck cancer; and (2) based on these findings, provide recommendations of which patient reported outcome measure or combination of measures most accurately reflects shoulder disability in patients who experience shoulder dysfunction following neck dissection surgery. two-hundred and fifty subjects will be recruited during regularly scheduled clinical visits at mayo clinic. subjects will complete five shoulder-related patient reported outcome measures on only one occasion, therefore subjects will be responsible for study participation only at the time of enrollment and same day completion of study-related documents. upon the conclusion of data collection, rasch analysis will be utilized to analyze data related to the research objectives, and descriptive statistics will be utilized to describe the sample.

Eligibility criteria:
inclusion criteria: * unilateral or bilateral neck dissection procedure for management of head and neck cancer within the past 2 weeks to 18 months * endorse some level of shoulder impairment (answer "yes" when asked "are you currently experiencing any shoulder weakness or discomfort as a result of your surgery?") * 18-90 years of age * adequate fluency in the english language to complete the study-related forms and questionnaires exclusion criteria: • no reported shoulder impairment
brief intervention for medication overuse headache

Conditions: Medication-overuse Headache; Chronic Headache

Summary: the investigators will perform a cluster randomised controlled study of brief intervention (bi) for medication-overuse headache (moh) versus business as usual. gps will be trained to perform a structured brief intervention after identifying patients with probable moh using the severity of dependence scale. the control arm will include patients of gps who have not been trained in bi. patients will be recruited by prior short postal screening of patients listed on the gps patient lists. the hypothesis is that bi will lead to improvement of medication-overuse and chronic headache as compared to no bi. main outcomes are: * number of medication days per month * number of headache days per month * headache index

123 cases in all included (75 in intervention/placebo control arms and 48 in non-intervention control arms) 19 did not meet predefined inclusion criteria for the different arms (5 and 8 in intervention arm and placebo arm respectively, 4 and 2 in chronic headache control and population control respectively) 1 case was lost to follow up in each of the 4 groups prior to first assessment. thus 60 cases remained in intervention/placebo control arms (24 in intervention and 36 in placebo control) and 40 in non intervention control arms (15 chronic headache controls, 25 population controls).

Eligibility criteria:
inclusion criteria: * 18-50 years of age * screening positive for possible chronic headache (\> 10 headache days per month) (not for population control arm) * screening positive for possible medication-overuse (\> 15 medication days per month) (not for chronic headache control arm) exclusion criteria: * other complicating pain with medication treatment
rilpivirine in virologically suppressed adolescents

Conditions: HIV

Summary: to describe the immunologic and virologic outcomes (hiv rna, cd4) following switching from efv to rpv in virologically suppressed adolescents

study procedures: at screening, the informed consent process will be provided to participant, or participant legally acceptable representatives before any study procedure. only adolescents who know their hiv status will be asked to give assent. twenty adolescents followed at hiv-nat and the department of pediatrics, faculty of medicine, chulalongkorn university will be asked to participate in the pk sub study. participant who are enrolled in the pk substudy will be asked to take rpv in the morning after breakfast and then commence the pk evaluations after this witnessed dose. after the pk study at week 4, participant will be followed with the other 80 adolescents until the end of the study. participant will be asked to provide a small hair sample for rpv concentrations at weeks 4, 12, 24, and 48 after switching. this is an option therefore participant can refuse to provide their hair samples at any visits. hiv rna levels will be performed at baseline, week 12, 24 and 48 visits. if the hiv-rna at any visits is between \>50 copies/ml, the hiv-rna test will be repeated within 4-8 weeks with adherence improvement counseling. at any visit, if hiv-rna is ≥1000 copies/ml, genotypic resistance testing will be performed. modification of treatment both for resistance and safety consideration will be subject to the site principal investigator's decision.

Eligibility criteria:
inclusion criteria: * hiv-infected adolescents aged 12-18 years; * body weight \>25 kilograms; * currently treated with stable efv-based haart (efv plus two nucleoside or nucleotide reverse transcriptase inhibitors \[n(t)rti\]) for \>3 months prior to enrollment; * plasma hiv rna \<50 copies/ml within the last 12 months; * alt \<200 iu/l within the last 12 months; * caregivers give written informed consent and adolescents who know their hiv status (i.e., have been fully disclosed to) give assent exclusion criteria: * has evidence of nnrti-associated resistance mutation(s) from previous genotypic resistance testing; * currently has pi(s) in the haart regimen; * has currently active hiv-related infection(s), (the subject can be enrolled after the infection is under controlled); * has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion); * pregnancy (postpartum women are allowed); * concomitant treatment with drugs known to effect the pk of rpv (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, omeprazole, esomeprazole, lansoprazole, erythromycin, clarithromycin, azithromycin, roxithromycin)

Keywords: immunological outcome virologic outcomes hiv-1 infected adolescents efv switch to rpv rilpivirine pharmacokinetic neuropsychiatric adverse events
geniculate artery embolization for the treatment of knee pain

Conditions: Osteoarthritis Of Knee

Summary: this study is to test a new treatment method, geniculate artery embolization (gae), to reduce the severity of pain and disability caused by knee osteoarthritis.

purpose: the primary aims of this study are to determine if geniculate artery embolization (gae) will reduce the severity of pain as well as global disability (resulting from the combination of pain, stiffness and difficulty performing daily activities) caused by knee oa and if it can be performed safely. the secondary aim is to determine if gae can result in the decreased necessity for ongoing conservative oa therapies such as medication therapy and joint injections. participants: twenty patients with knee osteoarthritis resulting in knee pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months. procedures (methods): this will be an open label 24-month pilot study with a small population undergoing gae to determine safety and efficacy. clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for geniculate artery embolization, and follow-up visits at 24 hours, 1, 3 \& 6 months. an mri will be performed at the 1-month visit to detect a change in synovial vascularity and to exclude complication.

Eligibility criteria:
inclusion criteria: * moderate to severe knee pain (visual analog scale (vas) \> 50 mm), and * pain refractory to at least 3 months\* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and * kellgren-lawrence grade 1, 2 or 3 on radiograph of the knee. exclusion criteria: * current local infection, or * life expectancy less than 6 months, or * known advanced atherosclerosis, or * rheumatoid or infectious arthritis, or * prior knee surgery, or * uncorrectable coagulopathy including international normalized ratio (inr) \> 2.5 or platelets \< 30,000, or * iodine allergy resulting in anaphylaxis, or * renal dysfunction as defined by serum creatinine \>1.6 dl/mg obtained within the past 30 days.
succinylcholine versus rocuronium for emergency intubation in intensive care

Conditions: Intubation

Summary: emergency intubation of patients in intensive care is a high-risk endeavour. for many decades, succinylcholine has been the neuromuscular blocking agent of choice. however, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. the nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. the aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.

objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations. design: prospective, randomized, single-blind study. setting: intensive care units of an university hospital. patients: adult patients in intensive care requiring emergency intubation. randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg). data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal co2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.

Eligibility criteria:
inclusion criteria: * indication for emergency intubation in intensive care * availability of qualified study physician exclusion criteria: * contraindication against succinylcholine or rocuronium * indication for awake fibreoptic intubation

Keywords: intubation intensive care neuromuscular depolarizing agents neuromuscular nondepolarizing agents neuromuscular blocking agents
acupuncture for patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: several studies investigating acupuncture for major depressive disorder (mdd) have been carried out. however, investigators found the results were in high heterogeneity and poor methodological quality. thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for mdd.


Eligibility criteria:
inclusion criteria: 1. right-handed participants aged between 18 to 60 years; 2. participants diagnosed with mild to moderate major depressive disorder(mdd), and meet the diagnostic criteria of mild to moderate mdd according to the diagnostic and statistical manual of mental disorders (fifth edition (dsm-5); 3. participants with score of hamd-24 between 8 to 35; 4. participants without anti-depressive medication more than 3 months; 5. participants willing to comply with the study protocol; 6. participants willing to sign informed consent form. exclusion criteria: 1. participants with severe medical visceral condition and chronic diseases, such as hypertension, coronary heart disease, hyperthyroidism, hypothyroidism or diabetes and other endocrine system diseases; 2. participants with brain organic diseases: such as birth injury, trauma, encephalitis, tumor, etc.; 3. participants with peripheral nerve and muscular system diseases; 4. participants with severe anxiety, obsessive-compulsive disorder, or a history of mania or hypomania; 5. recently taken drugs that may cause mood disorders; 6. severe bleeding tendency, allergic constitution and skin disease patients; 7. pregnant or lactation women; 8. persons with visual and hearing disabilities; 9. participants with pacemakers, deep brain stimulators, vagus nerve stimulators, metal internal fixators, etc 10. participate in other clinical trials at the same time

Keywords: acupuncture major depressive disorder randomized controlled trial
effects of aging and aerobic exercise training on brain glucose metabolism

Conditions: Dementia

Summary: aging is associated with a loss of brain function and conditions such as dementia and alzheimer's disease. it is likely that decreased brain metabolism is contributing to the progression of age related degenerative diseases. aerobic exercise training can increase brain volumes and is associated with decreased risk for degenerative brain conditions. however, little is know about the changes that occur to brain metabolism with aerobic training and aging.


Eligibility criteria:
healthy sedentary adults aged 18-30 or 65-80 years of all ethnicities will be eligible. pregnant women, children, prisoners or other at risk populations will not be recruited. inclusion criteria: * age 18-30 years or 65-80 years exclusion criteria: * body mass index (bmi) \>31 kg/m2 * smoking * pregnancy * participation in structured exercise (\>2 times per week for 30 minutes or longer) * cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dl and untreated hypo- or hyperthyroidism) or renal disease * orthopedic problems that would keep them from being able to ride an exercise bicycle, lift weights or do a combination of these exercise * medications that are known to impact on mitochondrial function: corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (ppar gamma agonist) * claustrophobia

Keywords: high intensity aerobic training
safety & efficacy study of quetiapine fumarate (seroquel®) vs. placebo in major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study is to evaluate that (seroquel®) quetiapine sustained-release is efficacious and safe in the treatment of patients with mdd.


Eligibility criteria:
inclusion criteria: * patient has a documented clinical diagnosis of major depressive disorder. * be able to understand and comply with the requirements of the study. * able to understand and provide written informed consent exclusion criteria: * patients (female) must not be pregnant or lactating * current or past diagnosis of stroke or transient ischemic attack (tia).

Keywords: mdd quetiapine fumarate, sustained release depression
symptom burden and unmet supportive care needs in lung cancer patients undergoing first or second line immunotherapy

Conditions: Lung Neoplasm

Summary: doctors are recruiting patients receiving care for lung cancer at the wake forest baptist comprehensive cancer center asking about needs and experiences during immunotherapy. immunotherapy is a new treatment for lung cancer. the research is to better understand patients' perspectives on what immunotherapy is like and will provide important information to help understand the symptoms patients experience, the impact of treatment on daily life, ways that people adapt to the challenges of treatment, and services that may help people live better during treatment.

the overall primary objective of this pilot study is to describe patient-reported symptom burden, unmet supportive care needs, and use of and interest in supportive care services in stage iv non-small cell lung cancer patients undergoing first or second line immunotherapy and to identify psychosocial factors associated with these outcomes. 60 stage iv non-small cell lung cancer patients will be recruited through the wake forest baptist comprehensive cancer center. the study team will use purposive sampling to assure representation of patients at different stages in immunotherapy (i.e., initiating treatment, anticipating scan results, after onset of immune-related side effects).

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iv (per ajcc 7th edition) non-small cell lung cancer. * receiving first or second line immunotherapy. * ecog performance status of 0-3. * english-speaking exclusion criteria: * unable to provide informed consent

Keywords: lung cancer immunotherapy stage iv cancer
arginine malaria trial: study of adjunctive arginine in falciparum malaria

Conditions: Malaria, Falciparum

Summary: acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide (no) production. both are associated with poor outcome. this study will examine the safety and effect of escalating doses of arginine in falciparum malaria. it will determine whether arginine can increase no production and have an effect on no-dependent physiological measurements. the hypothesis is that arginine: will be safe in falciparum malaria; will return plasma arginine concentration to normal/supranormal levels; will increase systemic and exhaled no; reduces oxidant stress; and improves a number of no-dependent physiological measures of relevance to malaria.


Eligibility criteria:
inclusion criteria: 1. ages 18-60 years 2. p. falciparum parasitemia (1,000-100,000 parasites/ul). 3. clinical syndrome consistent with malaria associated with documented fever (axillary temperature \> 38℃) or self-reported history of fever in the last 48 hours with no other cause present 4. commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine 5. an indication for hospital admission (eg relative cannot look after/supervise treatment at home but not having any warning signs or severe malaria criteria in "exclusion criteria" below) 6. informed consent obtained exclusion criteria: 1. pregnancy or lactation 2. mixed infection with p. falciparum and p. vivax 3. warning signs of altered mental state and inability to sit unaided 4. features of severe/complicated malaria 5. diabetes 6. systolic blood pressure (bp) \< 100 mmhg 7. serious underlying disease (cardiac, hepatic, kidney) 8. initial istat test showing any of the following values: * glucose \< 4 mmol/l; * k+ ≥ 4.2 meq/l; * cl- \> 106 meq/l; * hco3- \< 20 meq/l. 9. known allergy to l-arginine 10. concurrent therapy with any of the following medications: * spironolactone; * oral nitrates; * phosphodiesterase inhibitor (eg sildenafil \[viagra\]); * alpha-blocking antihypertensive agents (eg prazosin); * l-arginine.

Keywords: falciparum malaria arginine
extracorporeal shockwave therapy (eswt) to improve function in chronic asia-a patients

Conditions: Spinal Cord Injuries

Summary: the global prevalence of spinal cord injury is estimated between 236 to 4187/million. a spontaneous recovery of the sense-motoric function is decreasing with the time after injury and is only seen sporadically after 1 to 2 years. treatment options are mainly limited to improvement of the quality of life. the present prospective randomized study is intended as a double-blind, placebo controlled multi-center investigation. patients suffering from chronic paraplegia (lesion between thii and thx, asia a = complete central lesion) at least for 1 year after the initial trauma without spontaneous remission of the last 6 months are considered to be included in the study. meeting the inclusion criteria and signing the informed consent, patients are treated in one of the two study centers. at study inclusion, a baseline evaluation comprising neurological, neurophysiological, functional and clinical investigation is performed. patients dedicated to the eswt intervention group will be treated once a week over 6 weeks with local non-invasive low energy extracorporeal shockwave therapy (=6 treatments with an electrohydraulic device). the follow-up will include neurological, neurophysiological, clinical as well as functional evaluation at the time points 6 weeks, 3 months and 6 months. additionally, patients will be provided with a diary for documentation of drug adaptation, grade of spasticity and pain. those patients dedicated to the placebo eswt group, will receive the identical scheme in treatment (but without application of shockwaves) and follow-up as the patients in the eswt group. however, after positive completion of the study, these patients will be offered eswt as well.


Eligibility criteria:
inclusion criteria: * patients with a spinal cord injury classified as asia a between the level of thii to thx (complete central lesion) * at least 1 year after trauma * no signs of spontaneous recovery over the last 6 months * signed informed consent exclusion criteria: * central therapies over the last 6 months (eg stem cells, electro-therapy) * baclofen pump * joint contraction lower limb \> 40° (hip or knee) * body weight \> 135 kg * body height \> 202 cm * non-compliant patients * decubital ulcers at grade ii or higher * participation in an other clinical trial within the last 6 months * co-morbidities which make study completion doubtful or impossible * additional neurological diseases which may lead to further damage to the nerval system * malignant tumor

Keywords: shockwave eswt