Kornimate/medical-research-clean huggingface dataset:
clinical vs. anecdotal evidence - pediatric atopic dermatitis

Conditions: Atopic Dermatitis

Summary: in dermatology, topical anti-inflammatory medications, such as corticosteroids, are the mainstay treatment of managing patients with atopic dermatitis. however, caregivers are often apprehensive about choosing a topical steroid for a variety of reasons. many caregivers are not aware that clinical trial evidence for these medications exist, and instead may rely on anecdotal evidence in choosing to take these medications. because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. the goal of the study is to learn whether caregivers are more confident in treating a child's atopic dermatitis after being presented with varying amounts of information.

atopic dermatitis is the most common chronic, inflammatory dermatologic condition in young children, with a prevalence approaching 25% in some countries. topical corticosteroids, the mainstay treatment in managing atopic dermatitis, generally function to decrease inflammation and suppress the immune response. topical corticosteroids are grouped into distinct categories based on their degree of potency, including very high potency (clobetasol propionate), high potency (triamcinolone acetonide), medium potency (fluocinonide), and low potency agents (desonide). caregivers are often apprehensive about choosing a topical steroid for a variety of reasons. these include hearing negative information about the drug from friends or family, being nervous about treatment, or seeing the drug or its side effects negatively portrayed in the media. many parents/caregivers are not aware that clinical trial evidence for these medications exist, and instead may rely on anecdotal evidence in choosing to take these medications. because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. by understanding what kind of information will allow caregivers to be confident in their decision to use a topical corticosteroid, dermatologists may improve treatment adherence and outcomes. the goal of the study is to learn whether caregivers are more confident in treating a child's atopic dermatitis after being presented with varying amounts of information about the treatment.

Eligibility criteria:
inclusion criteria: * parent/caregiver of an individual age \<1-17 years old * subjects with a working knowledge of english exclusion criteria: * parent/caregiver of an individual 18 years or older

Keywords: atopic dermatitis eczema children
clinical assessment of fish oil-based lipid emulsion infusions in critical patients with severe sepsis

Conditions: Severe Sepsis

Summary: the purpose of this study is to determine whether a fish oil-based lipid emulsion, enriched with ω-3 fatty acids, reduce proinflammatory cytokines and mortality rate in critically ill patients with severe sepsis.


Eligibility criteria:
inclusion criteria: * patients admitted to li shin hospital's icu with a main diagnosis of severe sepsis. exclusion criteria: * age of ﹤15 years * pregnancy * patients treated with immunosuppressive drugs or the equivalent of hydrocortisone more than 300 mg daily * plasma triglyceride concentration of more than 400 mg/dl * infection with human immunodeficiency virus * anticipated rapid fatality from irreversible underlying disease or malignancy * severe hemorrhagic disorders * acute myocardial infarction * recent stroke (within 3 month) * suspected or proven pulmonary embolism * cirrhotic liver and/or acute hepatitis ( elevation of serum got or gpt \> 5 times of normal upper limit) * chronic renal failure (cr \>3.5 mg/dl upon admission) or end stage of renal diseases * allergic reactions against fish or egg proteins.

Keywords: severe sepsis proinflammatory cytokines icu
efficacy and safety of roflumilast taken in the morning or evening in patients with stable asthma (12 to 70 y) (by217/m2-015)

Conditions: Asthma

Summary: bronchial asthma is among the world's most prevalent diseases. roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. the aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. roflumilast will be administered orally either in the morning or in the evening at one dose level. the study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). the study will provide further data on safety, tolerability, and effectiveness of roflumilast.


Eligibility criteria:
main inclusion criteria: * written informed consent * diagnosis of persistent bronchial asthma (with reference to the global initiative for asthma guidelines 2002) * baseline fev1 50 - 85% in patients either untreated or receiving e.g. short-acting bronchodilators, dscg, nedocromil, anticholinergics, long-acting bronchodilators, theophylline/aminophylline, lipoxygenase inhibitors, leukotriene antagonists, alone or in combination * baseline fev1 60 - 90% in patients receiving not more than 500 mcg bdp-cfc (or equivalent) and/or in combination with any other asthma medication mentioned above * no change in the asthma treatment 4 weeks prior to baseline period * patients who, with the exception of asthma, are in good health main exclusion criteria: * poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period * patient using regularly \>8 puffs/day rescue medication prior to baseline * history of lower airway infection in the last 4 weeks prior to baseline period * diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases * heavy smoker: currently: \>20 cigarettes/day and/or \>10 pack years, ex-smoker: with a smoking history of ≥10 pack years * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation * liver insufficiency (child pugh a or worse) * active hepatitis * known infection with hiv * diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start * alcohol and/or drug abuse * suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication * pregnancy or patient of childbearing potential who is not using reliable method of contraception * patients not able to follow study procedures, e.g. due to language problems, psychological disorders * suspected inability or unwillingness to comply with the study procedures

Keywords: asthma roflumilast
the effects of functional action-observation training on gait ability in patients with chronic stroke

Conditions: Stroke

Summary: this study aimed to examine the effects of functional action observation training on gait ability in chronic stroke patients.


Eligibility criteria:
inclusion criteria: 1. diagnosis with stroke through computed tomography or magnetic resonance imaging, more than six months ago. 2. determination not to have cognitive disability, based on the score(\>24 point) of mini mental state examination-korea version. 3. determination not to have visual abnormalities including the unilateral neglect through the motor-free visual perception test(mvpt) 4. ability to independently gait longer than 10m in the room and to keep standing up without help. exclusion criteria: 1. surgery in the last three months 2. participating any other research
phase i combination with vinorelbine or gemcitabine plus cisplatin in locally advanced or metastatic nsclc

Conditions: Non Small Cell Lung Cancer

Summary: to test the safety and tolerability of zd6474 in combination withvinorelbine (navelbine) or gemcitabine (gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (stage iiib-iv) non small cell lung cancer.


Eligibility criteria:
inclusion criteria: * confirmed non small cell lung cancer (stage iiib-iv) * life expectancy greater than 12 weeks * at least 1 measurable lesion greater than 10mm in smallest diameter. exclusion criteria: * prior treatment with anticancer agent * brain metastases * major surgery within last 4 weeks

Keywords: nsclc zactima
pionir study (presillion™ and presillion™ plus stent systems)

Conditions: Ischemic Heart Disease

Summary: the purpose of this study is to collect and analyze additional information about the safety and effectiveness of the presillion™ stent system in the treatment of de novo stenotic lesions in native coronary arteries.

this is a post market, non-randomized, multi-center, prospective, single arm clinical study that will be conducted at up to 25 sites in europe and israel. all patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure. the primary endpoint will be the incidence of target vessel failure (tvf, see definition below) within 270 days of treatment with the presillion™ stent system. this rate will be compared with a performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. this data will be used to support the pma application for the presillion™ stent system.

Eligibility criteria:
inclusion criteria: 1. patient \>= 18 years old. 2. eligible for percutaneous coronary intervention (pci). 3. patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure. 4. patient is willing to comply with specified follow-up evaluation and can be contacted by telephone. 5. acceptable candidate for coronary artery bypass graft (cabg) surgery. 6. stable angina pectoris (canadian cardiovascular society (ccs) 1, 2, 3 or 4) or unstable angina pectoris (braunwald class 1-3, b-c) or a positive functional ischemia study (e.g., ett, spect, stress echocardiography or cardiac ct). 7. male or non-pregnant female patient (note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study). exclusion criteria: 1. currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints. 2. previously enrolled in another stent trial in the previous 2 years. 3. any planned elective surgery or percutaneous intervention within subsequent 9 months. 4. a previous coronary interventional procedure of any kind within the 30 days prior to the procedure. 5. the subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure. 6. previous drug eluting stent (des) deployment anywhere in the target vessel. 7. any drug eluting stent (des) deployment anywhere within the past 12 months 8. co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial. 9. concurrent medical condition with a life expectancy of less than 12 months. 10. known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, l-605 cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.

Keywords: stent interventional cardiology catheterization symptomatic ischemic heart disease
intensive therapy for children with microcephaly, hyperkinetic movements, or global developmental delay

Conditions: Microcephaly; Hyperkinesis With Developmental Delay; Global Developmental Delay

Summary: this trial will consist of a clinical series of up to 50 children with global developmental delay and concomitant microcephaly or hyperkinetic movements. all children will be assessed for psychomotor function using standardized assessments, goal specific assessments, with the potential addition of neuroimaging assessment, prior to and after receiving an intensive burst of neuromotor therapy. the interventional effects will be explored by comparing the pre and post interventional assessments and neuroimaging.

up to 50 children between the ages of 6 months and 15 years will be recruited to participate in a burst of intensive neuromotor intervention in the form of acquire therapy, delivered by the treatment team at virginia tech's neuromotor research clinic. all children will have a diagnosis of global developmental delay, with concomitant microcephaly or hyperkinetic movements. the children will be assessed for psychomotor function prior to and after the treatment intervention, using a series of standardized and goal specific assessments, with the possibility of additional neuroimaging assessments when possible. acquire therapy is an intensive intervention in that it is delivered with high intensity, wherein goal directed behaviors are promoted at high levels of repetition and delivered at a high dose (4-6 hours a day) in an intensive burst of 3-4 weeks of 5 day a week treatment. acquire therapy is an operant conditioning based intervention delivered in a cycle of refinement, reinforcement and repetition. it is play-based with activities selected to drive behavior toward goals that are specific to each child and selected based on each child's interests and needs. as such a specific protocol cannot be outlined. however, all goal directed activities are designed to promote awareness of and engagement with others and the environment.

Eligibility criteria:
inclusion criteria: * diagnosis of global developmental delay with microcephaly or hyperkinetic movements. exclusion criteria: * medical instability * under 6 months of age over 15 years of age

Keywords: global developmental delay hyperkinesis microcephaly neurorehabilitation intensive interventions
effect of left atrial ablation on left atrial appendage emptying flow velocity

Conditions: Atrial Fibrillation

Summary: consecutive patients with paroxysmal afib scheduled to undergo pulmonary vein isolation either with radiofrequency (rf) or cryoballoon will be included. left atrial appendage emptying flow velocity (laa-efv) will be measured with transesophageal echocardiography (tee) immediately before and following left atrial ablation (1 month post). the change in laa-efv will be compared between the two groups (rf versus cryo).


Eligibility criteria:
inclusion criteria: paroxysmal atrial fibrillation, no absolute contraindication for anticoagulation exclusion criteria: previous cardiac surgery previous left atrial ablation history of cerebrovascular event presence of laa thrombus inability to provide informed consent
a dose-ranging study evaluating the safety and efficacy of idp-107 in patients with acne vulgaris

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the safety and efficacy of idp-107 versus placebo in treating patients with acne vulgaris.


Eligibility criteria:
inclusion criteria: * presence of acne vulgaris on the face and neck/trunk * presence of inflammatory and non-inflammatory lesions on the face exclusion criteria: * presence of any skin condition on the face that could interfere with clinical evaluations * use of any systemic antibiotics or corticosteroids within 4 weeks prior to the baseline visit * use of any systemic retinoids, such as isotretinoin, within 3 months prior to the baseline visit * woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
selectsecure 3830 lead imaging

Conditions: Heart Diseases

Summary: this study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released selectsecure 3830 lead for the purposes of developing a fracture reliability model.


Eligibility criteria:
inclusion criteria: * patients who are at least 18 years of age * patient has a pacing, icd or crt system incorporating at least one selectsecure 3830 lead in the right atrium or right ventricle * patients able and willing to attend imaging session * patients able and willing to give informed consent * pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment * patient must be able to accomplish arm flexion and adduction past 90 degrees exclusion criteria: * subjects who require a legally authorized representative to obtain consent * subjects with exclusion criteria required by local law (e.g. age, breastfeeding) * pregnant women, or women of child bearing potential and who are not on a reliable form of birth control * subjects that were implanted with a pacing, icd, crt device and/or cardiac leads less than three months ago
who will benefit from bariatric surgery for diabetes?

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: a study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (t2dm) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.


Eligibility criteria:
bariatric surgery group inclusion criteria: * males and females planning to undergo rygb * 18-80 years * type 2 diabetes mellitus or prediabetes * stable weight for at least 3 months * obese (bmi ≥30kg/m2) * eligible for surgery on the national health service (nhs) under the national institute for health and care excellence (nice) 2014 criteria exclusion criteria: * current pregnancy * inability to give informed consent * type 1 diabetes * low fasting c-peptide * secondary diabetes or absence of β-cell function * unable to undergo dexa, cirrhosis, ascites, or other condition that may modify body fat composition e.g. underlying malignancy * current smoker * participation in another (interventional) trial within the last 3 months * unable to understand english healthy volunteers inclusion criteria: * aged 18-80 years * male or female * body mass index 19 - 25 kg/m2 * stable weight for at least three months exclusion criteria: * abnormal glucose tolerance and fasting glucose * history of any medical, or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study * without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study * pregnancy or breastfeeding * unable to maintain adequate contraception for the duration of the study * donated blood during the preceding 3 months or intention to do so before the end of the study * current smoker * participation in another trial within the last 3 months * unable to understand english
treatment adherence when using rebismart™ in relapsing multiple sclerosis subjects

Conditions: Multiple Sclerosis; MS

Summary: this is a multi-center, two-arm non-comparative, observational, 96 week phase iv study to evaluate treatment adherence when using rebismart™ for self-injection of rebif® in subjects with relapsing multiple sclerosis (rms). subjects who have a confirmed diagnosis of rms using mcdonald criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (rebismart™) to inject rebif® for 96 weeks. the main purpose of this study is to evaluate treatment adherence for subjects with rms over 24 weeks of treatment when using rebismart™ for self-injection of rebif® in a multi-dose cartridge.


Eligibility criteria:
inclusion criteria: * males and females between 18 and 65 years of age. * have rms according to the revised mcdonald criteria. * subject is eligible for rebif® therapy according to indications and clinical use in the rebif® product monograph. * be willing and able to comply with the protocol requirements for the duration of the study. * have given written informed consent prior to entering the screening period. * must register with the rebif® multiple support program. * subjects previously on disease modifying drugs (dmds) must be stable and not be experiencing any side effects related to the previous dmds at the time of enrollment into the study, in the opinion of the investigator. rebif® will be prescribed as per product monograph and a washout period will be left at the discretion of the investigator. exclusion criteria: * have any disease other than ms that could better explain his/her signs and symptoms. * receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. the administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's ms (e.g.,influenza or pneumococcus vaccination) will be acceptable. * are contraindicated for the use of rebif® according to the rebif® product monograph. * have a diagnosis of clinically isolated syndrome (cis). * participation in any other investigational trial prior to 30 days of study day 1. * any visual or physical impairment that precludes the subject from self-injecting the treatment using rebismart™ * have received previous treatment with rebif within 5 years prior to screening. * subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.

Keywords: rebismart rebif adherence multidose relapsing multiple sclerosis rms