Kornimate/medical-research-clean huggingface dataset:
mixed-method research protocol: evaluation of a relaxation technique for anxiety management in pre-surgical pediatric patients

Conditions: Surgeries Requiring a Minimum One Day Hospitalization; Anxiety

Summary: children exhibit anxiety before surgery: in particular, the literature reports that younger children have a higher level of preoperative anxiety than older children. preoperative anxiety has been associated with side effects such as postoperative pain and emergence delirium (ed), which are generally treated with the administration of analgesics but can cause nausea, vomiting, and drowsiness. in addition to pharmacological strategies, there are behavioral and psychological techniques commonly referred to as nonpharmacological techniques to reduce preoperative anxiety. these are a broad set of strategies and methods, more or less complex, that can be applied to children and adolescents to help them cope with preoperative agitation and for pain control. nonpharmacological techniques include distraction techniques that have shown promise in reducing pediatric anxiety and include listening to music , the use of humor, and the use of games . several researchers have found active distraction to be an effective preoperative anxiolytic in children. of relevant importance for reducing preoperative anxiety are relaxation techniques as shown in the literature and in particular by a randomized trial that demonstrated the effectiveness of this type of proposed nonpharmacological technique for reducing anxiety and pain in pediatric patients in a preoperative setting. this study plan to investigate the effectiveness of a breathing/relaxation intervention (ladybug/sunshine method) on pediatric patients' anxiety levels before surgery.


Eligibility criteria:
inclusion criteria: * age between 5 years and 15 years; * admission for minor surgical conditions of low intensity, such as inguinal hernia, phimosis, sebaceous cysts, vascular malformations, skin lesions, ankyloglossus, afferent to the unified pediatric surgery day-surgery service of aou meyer; * knowledge of the italian language and ability to express oneself; exclusion criteria: * presence of cognitive impairment reported in history
endocrine regulation of lipolysis in obesity and diabetes

Conditions: Obesity; Diabetes

Summary: adipose tissue (at) dysfunction is a commonly observed feature of metabolic dysfunction in obesity and diabetes. an important characteristic when examining at function is the capacity to break down stored lipids (i.e. lipolysis) and its regulation. in the present study, the aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects with or without type 2 diabetes, compared to age-matched lean men. eventually, the knowledge gained from this research will contribute to a better understanding of the present adipose tissue dysfunction and to the optimization of exercise programs for people with obesity and diabetes.


Eligibility criteria:
inclusion criteria: * lean group: bmi \< 25 kg/m², insulin sensitive (homa-insuline resistance (ir) \< 2.3), age 40-65 * obese groups: bmi \> 30 kg/m², presence or absence of type 2 diabetes based on use of glucose lowering medication or hba1c \> 6.5%, age 40-65 exclusion criteria: * presence of a history of heart, lung or kidney disease and/or presence of endocrine anomalies. use of beta-blockade medication.
a study to evaluate the clinical efficacy and safety of tobradex® st compared to azasite® in the treatment of subjects with moderate to severe chronic blepharitis

Conditions: Blepharitis

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of tobradex st compared to azasite in the treatment of moderate to severe chronic blepharitis.


Eligibility criteria:
inclusion criteria: * have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye * have a minimum global score (the total signs and symptoms score) of 5 in the same eye qualifying. exclusion criteria: * have known sensitivity or poor tolerance to the test article (tobramycin, dexamethasone, azithromycin) or its components or any therapy associated with the trial * have a history of ocular surgical intervention within six (6) weeks prior to visit 1 or during the study * have any ocular infections (bacterial, viral or fungal) - active ocular inflammation (i.e. follicular conjunctivitis, iritis) or preauricular lymphadenopathy, other than blepharitis * have worn contact lenses in the 72 hours prior to visit 1 and for the duration of the study * are currently taking any medication known to cause ocular drying that has not been on a stable dose for at least 30 days * have used any topical ocular or systemic antibiotics within 7 days of enrollment. stable (greater than 1 month prior to enrollment) use of topical antibiotics on the face (except around the eyes) for dermatologic conditions is allowed. dose must continue unchanged for duration of study * have used any topical ocular - aerosolized/nebulized - or systemic corticosteroid agents within 14 days of enrollment. stable (greater than 1 month prior to enrollment) use of inhaled (using mouthpiece) and nasal corticosteroids and topical dermal steroids (except around the eyelids) are allowed. dose must continue unchanged for the duration of the study.

Keywords: blepharitis moderate to severe chronic blepharitis
michigan men's diabetes project

Conditions: Diabetes Mellitus, Type 2

Summary: the investigators propose to develop a training for male peer leaders facilitating diabetes self-management education and support (dsmes) to specifically encourage conversations regarding beliefs that affect men's health and to allow modeling of alternative views and perspectives that allow for successful disease management to be framed as competence and strength. given that the life expectancy for black men in the us is 71, the investigators hypothesize that targeting men in earlier stages of type 2 diabetes (t2d) will assist greatly in facilitating healthy aging and improving diabetes-related health outcomes later in life. based on the investigators previous work, the long-term goal of our research is to determine the most effective, practical, and sustainable approach to provide dsmes to older black men. the objective is to examine the relative effectiveness, feasibility, and acceptability of a peer-leader dsmes intervention for black men with t2d. to accomplish this, the investigators will engage in a developmental phase and a validation phase \[pilot randomized control trial (rct)\]. the rct will be conducted with 60 black adult male residents of metro detroit, michigan. participants will be randomized to a control group or the tailored peer-leader diabetes self-management support group (pldsms). all participants will receive dsme with a certified diabetes care and education specialists. only participants randomized to the pldsms group will also receive an additional 6 weeks of dsms led by the peer leaders. the investigators hypothesize that 1) participants in the pldsms group will have improved outcomes (a1c, blood pressure, weight, diabetes distress, self-management behaviors, etc.) over the control group, and 2) an evaluation of measures will confirm efficacy of the pldsms.


Eligibility criteria:
inclusion criteria: * male * age 55 or older * black/african american * diagnosis of type 2 diabetes for a six-month duration or longer. exclusion criteria: * non-ambulatory * serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy) * psychiatric illness (severity requiring hospitalization) * cognitive deficit * serious diabetes complications (e.g. blindness) that would impede meaningful participation.
texting to promote tobacco abstinence in emergency department smokers: a pilot study

Conditions: Smoking; Tobacco Abstinence

Summary: this is a pilot study to test the feasibility of conducting a text based smoking cessation trial with emergency department patients who are smokers.


Eligibility criteria:
inclusion criteria: * 18 years or older * have smoked \>= 100 cigarettes lifetime * describe themselves as every or some day smokers * are able to give written informed consent * reside in connecticut * own a cell phone with texting capability. exclusion criteria: * inability to read or understand english * currently receiving formal tobacco dependence treatment * current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette) * currently using zyban (bupropion), wellbutrin (bupropion) or chantix (varenicline) for smoking cessation * current suicide or homicide risk * current psychotic disorder * life-threatening or unstable medical or psychiatric condition * does not have phone with ct area code and with texting capability * lacks capacity to give informed consent * leaving the ed against medical advice * pregnant, nursing, or trying to conceive * incarcerated * resides in an extended care facility

Keywords: standard care condition texting + nrt condition
hand function impairment in systemic sclerosis: outcomes, mechanisms and experience (handsome)

Conditions: Systemic Sclerosis

Summary: almost 90% of systemic sclerosis (ssc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. an important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. with this longitudinal cohort study in patients with ssc and vedoss (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.


Eligibility criteria:
inclusion criteria: * age \> 18 years exclusion criteria: * patients with diabetic cheiroarthropathy and dupuytren's disease, based on expert opinion
comparison of medical and surgical treatments of benign prostate hyperplasia in patients who have low grade non muscle invasive bladder cancer for tumour recurrence and progression

Conditions: Bladder Cancer

Summary: the purpose of this study is to compare medical and surgical treatments of benign prostate hyperplasia in patients who have non muscle invasive bladder cancer for tumour recurrence and progression.


Eligibility criteria:
inclusion criteria: * patients who have non muscle invasive bladder cancer male patients patients between 40-80 years old exclusion criteria: * patients who have previous prostate surgery patients who have muscle invasive bladder cancer

Keywords: bph bladder cancer treatment recurrence progression
impact of self-monitoring technology and interventionist contact on weight loss

Conditions: Overweight; Obesity

Summary: despite continued research on effective interventions, obesity remains a major public health issue in the united states. current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these treatments to address the population-wide scope of the obesity epidemic. recent advances in technology that improve the ease of self-monitoring and provide targeted feedback offer promise to help larger groups of individuals to lose weight. despite the commercial popularity of these products, however, little research has been conducted to evaluate their impact on excess body weight or to determine how they should ideally be implemented. two key questions need to be addressed. first, is use of self-monitoring technology sufficient to produce weight loss, or must this technology be combined with interventionist contact? second, how cost-effective is a technology-based intervention, with and without interventionist contact? the current study is small prospective, randomized pilot study comparing a self-guided self-monitoring condition (sc) to a technology only condition (tech) and a technology plus interventionist support condition (tech+int). all participants will all be given basic weight management information knowledge and randomized to one of three conditions. participants in the self-guided self-monitoring condition (sc) will receive traditional paper self-monitoring logs, a standard body weight scale, and a pedometer and calorie book; participants in the technology-based condition (tech) will receive an electronic activity monitor and wifi-enabled body weight scale, and will track caloric intake via an associated website; and participants in the interventionist contact condition (tech+int) will receive the same technology as in the tech condition, combined with weekly interventionist contact delivered via telephone. we will compare the impact of each condition on weight loss and investigate preliminary cost-effectiveness.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 * bmi between 27 and 40 kg/m2 * access to a computer and wifi in the home exclusion criteria: * weight over 340 lbs * physical limitations that prevent walking 1/4 mile without stopping * currently participating in another weight loss program or taking weight loss medication * currently pregnant, lactating, less than 6-months post-partum, or plans to become pregnant during the 6-month study period * uncontrolled hypertension or diabetes * history of coronary heart disease * terminal illness * plans to relocate during the 6-month study period * substance abuse * severe psychiatric disorders * dementia

Keywords: overweight obesity weight loss self-monitoring food records self-weighing technology
increasing knowledge and interest in cancer clinical trials

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this trial investigates how well a video-based clinical trial education session works in increasing knowledge and interest in cancer clinical trials among individuals in the metropolitan detroit region of the karmanos cancer institute (kci) catchment area. this educational activity may help researchers learn more about individuals' awareness of clinical trials, knowledge, and intention to participates in a clinical trial.

primary objective: i. to increase cancer clinical trial knowledge and interest through video-based education among individuals aged 21 and older in the metropolitan detroit region of the kci catchment area. outline: participants view educational video consisting of information on the purpose of clinical trials, myths associated with clinical trials, and how to find more information about clinical trials.

Eligibility criteria:
inclusion criteria: * individuals aged 21 and older * participants will be identified through karmanos cancer institute's (kci) clinical treatment center * participants will be identified through community-based kci-sponsored events * participants will have voiced an interest to participate followed by an informed consent exclusion criteria * none
study on ultrapro vs polypropylene: early results from a multicentric experience in surgery for hernia

Conditions: Chronic Pain

Summary: with reference to inguinal hernia surgeries with prosthesis, the multicenter study aims to investigate the benefits in terms of incidence of pain and discomfort, improvement in the quality of life for the patient after the use of the newly introduced semi-absorbable prosthesis (ultrapro® meshes) compared with the prosthesis of totally nonabsorbable material (conventional meshes in polypropylene "prolene®"), and in terms of the costs for the hospital, the national health system (nhs), and the society of associates for the use of the ultrapro® in inguinal hernia surgeries.


Eligibility criteria:
inclusion criteria: * elective surgery * males and females * adults over 18 * all primitive inguinal hernia exclusion criteria: * emergency surgery * impossibility to complete the follow-up * patients with acquired immunodeficiency symptoms * patients with relapsed inguinal hernia
oxidative skeletal muscle metabolism in chronic heart failure patients with and without iron deficiency

Conditions: HF - Heart Failure; Iron-deficiency

Summary: observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31p mrs) to quantify the effect of iron deficiency (id) on skeletal oxidative metabolism in patients with chronic heart failure (hf).

iron deficiency (id) is a comorbidity in heart failure (hf) patients with high prevalence and severe clinical consequences. multiple studies have shown that id in hf patients impairs exercise capacity, quality of life and outcome. it is currently unknown whether these detrimental consequences of id are due to cardiovascular or hematologic effects, or deteriorated peripheral muscle metabolism and function. this study was designed to quantify the effect of id on skeletal oxidative metabolism in patients with chronic hf.

Eligibility criteria:
inclusion criteria: for hfref patients: * diagnosis of chronic hf of either ischemic or non-ischemic etiology; * stable, evidence-based medical therapy for hf; * lvef \<40% measured \<5 year prior to inclusion; * nyha class ii - iii (symptomatic hf) at moment of inclusion; for hfpef patients: * diagnosis of chronic hf of either ischemic or non-ischemic etiology; * lvef \>40% and one of the following parameters, measured \<5 year prior to inclusion; * left atrial volume index (lavi) \>34 ml/m2 or * left ventricular mass index ≥115 g/m2 (for males) or ≥95 g/m2 (for females) or * e/e' ≥13 or * mean e' (septal and lateral) \<9 cm/s * nyha class ii - iii (symptomatic hf) at moment of inclusion; * serum nt-probnp ≥125 pg/ml when in sinus rhythm; \>300 pg/ml when in atrial fibrillation. additional inclusion criterion for subjects with id: - iron deficiency, defined as tsat \<20%. exclusion criteria: * age \<18 years; * unable or unwilling to undergo exercise mri (e.g. pregnancy, physical disabilities, claustrophobia); * the presence of ferromagnetic material in/on the body which cannot be removed (e.g. non-mri-compatible cardiac devices, tattoos containing ferrous ink); * history of erythropoietin stimulating agent, intravenous iron therapy and/or blood transfusion \<3 months prior to study enrolment; * moderate anaemia, defined as hb \<7 mmol/l for both men and women; * oral iron therapy \>100 mg/day \<4 weeks prior to study enrolment; * unable to understand study procedures; * unable or unwilling to provide informed consent.

Keywords: 31p mrs 31phosphor magnetic resonance spectroscopy hfpef hfref oxidative skeletal muscle metabolism
viewing strategy training in children with (cerebral) visual impairment

Conditions: Vision Disorders; Vision, Low

Summary: viewing strategies are strategies used to process visual information. many children with visual impairment seem to lack systematic viewing strategies. however, it is unknown how viewing strategies differ between children with normal vision and children with (cerebral) visual impairment. in addition, viewing strategy training is often adopted in clinical practice, but till date there is no scientific evidence about effectiveness of this approach. the current project has two goals: (1) to measure viewing strategies used by children with normal vision, children with ocular visual impairment and children with cvi, and (2) to evaluate whether training viewing strategies results in more efficiënt visual information processing.


Eligibility criteria:
inclusion criteria typically developing children with normal vision: * age 5-12 years * linear distant visual acuity of 0.1 logmar or better * verbal iq above 70 * absence of developmental disorders or psychiatric problems like ass or ad(h)d inclusion criteria for children with ocular visual impairment: * age 5-12 years * children with linear distance visual acuity better \ 0.1 logmar * intact central visual field (at least \> 30 degrees) * children with a verbal iq above 70 * absence of developmental disorders or psychiatric problems like ass or ad(h)d inclusion criteria for children with cerebral visual impairment: * age 5-12 years * linear distance visual acuity \<=0.3 logmar * having the diagnosis cvi (verified by ophthalmologists) * children with a verbal iq above 70 * absence of psychiatric problems like ass or ad(h)d additional inclusion criterion for study 2 (evaluating training effectiveness): children with (cerebral) visual impairment should have an indication for viewing strategy training. training should not be indicated if children have no problems performing academic tasks (i.e. when speed and accuracy of visual processing is within the normal range). the age range for study 2 is 5-9 years. exclusion criteria: * children with vi: linear near visual acuity \>1.0 logmar * children with visual field defect \< 30 degrees * children with a verbal iq below 70 * children who attended a form of vision training in the past two years * children with psychiatric problems like ass or ad(h)d * auditory impairment or language impairments * major life events during training

Keywords: viewing strategies (cerebral) visual impairment visual rehabilitation reading strategies visual search strategies
genetic risk factors for severe asthma

Conditions: Asthma

Summary: the purpose of this study is to determine whether a specific genetic factor influences the severity of asthma symptoms.

asthma is one of the most common chronic diseases in the united states. it is well known that asthma susceptibility is inherited; however, it is unknown if asthma severity is heritable. studies suggest that levels of interleukin-16 (il-16) may influence asthma severity. this study will examine the role of differences in the control region of the il-16 gene in a racially diverse group of asthmatics and nonasthmatics and will determine if the il-16 gene control region is related to asthma severity. participants in this study will undergo lung function and blood tests; they will also complete a questionnaire about their respiratory health. asthmatic participants will complete a severity-of-asthma questionnaire.

Eligibility criteria:
inclusion criteria for asthmatic participants: * diagnosis of asthma inclusion criteria for non-asthmatic participants: * no diagnosis of asthma
disability among adults with asthma

Conditions: Asthma; Lung Diseases

Summary: to identify risk factors for work disability among adults with asthma treated by pulmonary and allergy specialists.

background: disability among those with asthma is common and costly. little is known about the causes of disability in asthma; experience with other chronic diseases suggests that illness severity alone does not adequately predict disability. there is a theoretical and experimental basis upon which to postulate that other variables, including factors such as job flexibility, asthma self-efficacy, social supports, and cigarette smoking may be predictors of disability in asthma. the study helped to explain the inter-relationships among illness severity, other co-factors and disability in asthma, addressing a major research gap. design narrative: the study was a cross-sectional survey, including retrospective work history data. a random sample was conducted of 40 board certified pulmonologists in northern california enrolling persons with asthma. pulmonologists maintained a log of all persons meeting a clinical definition of asthma presenting to their offices for treatment over a one month period. a total of 601 subjects with any history of laborforce participation were interviewed by a trained survey worker in order to assess severity of disease using a severity scale based on symptoms, medications, and past-asthma history. the computer-assisted, telephone-administered interviews used established survey instruments to assess psychosocial variables, smoking exposure and work history. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria