Kornimate/medical-research-clean huggingface dataset:
epidemiology of pediatric asthma hospitalization

Conditions: Asthma; Lung Diseases

Summary: to study three possible, but yet unproven, influences on pediatric asthma hospitalization rates - diagnostic substitution, different systems of medical care, and asthma medication use.

background: recent research has shown that asthma admission rates for children vary widely across geographic areas and have increased nationally for the past decade. the results from these studies will have direct relevance to the clinical care and development of public policy for children with asthma. design narrative: specific hypotheses regarding these factors which influence pediatric asthma hospitalization were tested in two different data sets: ecologic studies of trends and area variations of the children residing in the contiguous states of maine, new hampshire, and vermont for 1980 - 1994; retrospective cohort analyses of children enrolled at a staff model hmo, group health cooperative of puget sound for 1977 - 1994. these studies utilized detailed information regarding area and individual 'exposure' to differing systems of health care and asthma medications, controlling for socioeconomic status.

Eligibility criteria:
no eligibility criteria
is monitoring activity important for short- and long-term weight loss?

Conditions: Overweight and Obesity

Summary: this study is comparing the effectiveness of two techniques for monitoring physical activity and energy balance on long-term weight management (two years). the focus is on weight loss, prevention of weight gain, and the maintenance of a healthy weight over time. it is expected that both techniques will benefit long-term weight management.

the major objective of this study is to determine if two techniques for monitoring physical activity and energy balance promote the maintenance of weight loss in healthy overweight and obese individuals. the study compares two approaches designed to help individuals monitor physical activity and to adjust their calorie intake to maintain a reasonable energy balance (bodybugg® \& step diet book systems). full subject participation in the study spans two years. participants periodically report to a pre-arranged location to be measured by a qualified fitness professional for height, weight, circumferences, and estimated body fat using a bioelectric impedance scale (body fat scale).

Eligibility criteria:
inclusion criteria: * desire to lose weight * height: 60-76 inches * bmi 27-40 * healthy exclusion criteria: * currently enrolled in a weight loss program * currently under medical care for obesity treatment * using drug, supplement, or similar treatment to promote weight loss * have undergone bariatric surgery or have breast implants * intend to have surgery within the next 24 months * have had an eating disorder * are pregnant, breast-feeding, or plan to become pregnant within 24 months * are planning an extended vacation, absence, or relocation within 24 months * use tobacco products * frequently consume 2 or more alcoholic drinks per day * use illegal drugs, steroids, or growth hormone * use any appetite-affecting medications * are eating a physician-supervised diet * have other problems that might interfere with ability to participate

Keywords: overweight obesity accelerometer pedometer energy balance weight loss weight maintenance
stroke caregiver empowerment

Conditions: Stroke

Summary: the purpose of this study is to refine stroke-care for caregivers and explore changes in caregiver and care-recipient outcomes

individuals with disabilities rely heavily on unpaid family caregivers to help perform necessary occupations. the emotional and physical demands of caregiving often contribute to caregivers experiencing burden. caregivers with burden are at-risk for poor health and a heightened risk of mortality. this is likely, in turn, to negatively impact care-recipient quality of life. the proposed study refines a behavioral intervention that teaches caregivers to facilitate problem solving over the course of daily activities. the long-term goal for this project is to establish an effective rehabilitation intervention that promotes caregiver health and well-being, which ultimately influences care-recipient health. this study will use an open-case series and a single-arm clinical trial to refine the intervention and examine caregiver and care-recipient response to the intervention. this research applies to the priorities and objectives of this research initiative through examination of a caregiver-centered, standardized intervention that is based on occupational theories and principles, investigating outcomes experienced by caregivers of individuals with cognitive deficits after stroke. data from this pilot project will be used to design and obtain federal funding for a randomized controlled trial to examine the efficacy of the refined intervention on caregiver and care-recipient health outcomes.

Eligibility criteria:
inclusion criteria: * 18 years or older * primary caregiver for an individual post-stroke * live with the care-recipient * provide 1 hour of caregiving per day * subjective caregiver burden exclusion criteria: * non-english speaking * active treatment (chemotherapy, radiation therapy) for cancer * imminent placement of care-recipient into a nursing home or with another caregiver (within 6 months) * involvement in another clinical trial for caregivers

Keywords: empowerment caregiver
effects of fixed and removable space maintainers on periodontal health and dmft/dft values

Conditions: Dental Plaque

Summary: space maintainers are appliances that applied when primary teeth were lost prematurely because of many reasons such as tooth decay, trauma, lack of germ of permanent tooth.4 space problems play an important role in practice of dentistry and also understanding of the dental development in the primary and mixed dentitions could help to intercept the malocclusion.the aim of this study is to evaluate the effects of applied space maintainers on periodontal health and dental status after teeth missing in pediatric dentistry clinic.

the study was approved by the ethics committee of the istanbul university faculty of dentistry (no:2014/8) and was carried out in agreement with the declaration of helsinki principles. this study conducted 104 patient whose age between the range of 4-15 years were chosen to applied fixed (band and loop, palatal arch, lingual arch) or removable space maintainers in istanbul university faculty of dentistry department of pediatric dentistry were followed between years of 2013-2014. totally, four of the patients excluded due to systemically and genetically disorder. in primary and mixed dentition, dft index was used and in permanent dentition dmft index was used. longevity time in the mouth, the number of developing new caries were evaluated and dmft/dft and plaque index were compared.

Eligibility criteria:
inclusion criteria: * healthy and applied space maintainer patients exclusion criteria: * unhealthy and non-applied space maintainer patients

Keywords: oral health dental plaque space maintenance
long-term safety and efficacy of ferriprox® in iron overloaded patients with sickle cell disease or other anemias

Conditions: Iron Overload; Sickle Cell Disease; Other Anemias

Summary: this is a long-term follow-up to an earlier study, la38-0411. its purpose is to gather more information about the safety and efficacy of deferiprone in patients with sickle cell disease or other anemias who suffer from iron overload caused by regular blood transfusions.

deferiprone (brand name ferriprox®) is an iron chelator that is approved in the united states and over 60 other countries for the treatment of iron overload in patients with thalassemia, when other treatments are inadequate. this study has been designed to evaluate the long-term efficacy, safety, and tolerability of deferiprone to treat iron overload in patients who have sickle cell disease or other anemias. only patients who have completed an earlier study, la38-0411, are eligible to enroll in this one.

Eligibility criteria:
inclusion criteria: 1. completed study la38-0411 2. females of childbearing potential must have a negative pregnancy test result at visit 1. in addition, if applicable, they must: * use an effective method of contraception according to local requirements, during the study and within 30 days following their last dose of study medication, or * have had a tubal ligation (supporting evidence required), or * have had a hysterectomy (supporting evidence required), or * participate in a non-heterosexual lifestyle, or * have a male sexual partner who has been sterilized (supporting evidence required) 3. fertile heterosexual males and/or their partners must agree to use an effective method of contraception during the study and for 30 days following the last dose of study medication 4. all patients and/or their authorized legal representatives must provide signed and dated written informed consent prior to the first study intervention, and assent will be obtained from patients who are considered to be minors. patients must be able to adhere to study restrictions, appointments, and evaluation schedules. exclusion criteria: 1. plan to participate in another clinical trial at any time from the day of enrollment until 30 days post-treatment in the current study 2. for only those patients who were treated with deferoxamine in study la38-0411 (group 2): presence of any medical condition (including clinically significant laboratory abnormalities, such as alt (alanine aminotransferase) ≥ 5 x uln or creatinine ≥ 2 x uln), psychological condition, or psychiatric condition which in the opinion of the investigator would cause participation in the study to be unwise. 3. pregnant, breastfeeding, or planning to become pregnant during the study period. 4. treatment failure after 1 year on deferiprone which in the investigator's judgment indicates the need for the patient to be started on a different iron chelator

Keywords: iron overload sickle cell disease deferiprone ferriprox iron chelation
peripheral vs. selective tumor marker venous sampling in prostate cancer

Conditions: Prostate Cancer

Summary: the investigators will compare tumor marker levels, including psa, in samples taken from a peripheral upper limb vein and the internal iliac veins. these will be collected from patients who are scheduled for prostatectomy as part of their standard of care for prostate cancer. a selective internal iliac vein sampling procedure will be performed in interventional radiology. venous samples will be correlated with prostatectomy specimens. the aim is to predict the side of the prostate containing tumor.


Eligibility criteria:
inclusion criteria: 1. all male patients, age 18 to 99, with biopsy proven prostate adenocarcinoma prior to planned radical prostatectomy. 2. informed consent/hipaa form discussed and signed by subject. 3. baseline lab values obtained within 120 days of planned selective venous sampling. exclusion criteria: 1. skin related problems around the planned venepuncture site (infection, phlebitis, scars) 2. documented allergy to iodinated contrast or lidocaine. 3. coagulopathy with an inr of greater than 1.5 4. thrombocytopenia with platelets less than 25,000 ul 5. renal insufficiency with a creatinine of 1.5 mg/dl 6. documented current upper extremity or central venous thrombosis 7. dre within 4 weeks prior to selective venous sampling 8. prostate biopsy within 6 weeks prior to selective venous sampling. 9. patient unable to sign his own consent or does not demonstrate full understanding of the procedure. 10. patient has known metastatic disease or a known primary cancer other than prostate adenocarcinoma. 11. patient has already been enrolled in this research study. 12. life expectancy less than 6 months.
safety and effectiveness of an experimental drug, im862, in treating kaposi's sarcoma in aids patients

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to use im862 to treat kaposi's sarcoma (ks) in aids patients.

patients are stratified by cd4 count, viral load, and prior systemic chemotherapy. patients are randomized equally to receive either im862 or placebo given intranasally every other day. patients are seen every 4 weeks for 6 months or until disease progression to evaluate toxicity and efficacy. quality of life is assessed before treatment, then every month for 6 months. at the end of the 6-month study evaluation period, patients with pr/cr (responders) remain on study and continue blinded treatment for an additional 6 months. for patients with stable disease (non-responders), the treatment assignment is unblinded and off-study im862 compassionate use is offered for 6 months, regardless of treatment group. for patients with documented progressive disease (treatment failure), the treatment assignment is unblinded and off-study im862 is offered for 6 months to any patient in the placebo group. for treatment failures in the im862 group, im862 is stopped and the patient is allowed other therapy options.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have aids-related kaposi's sarcoma. * have at least 5 skin or mouth sores that do not require chemotherapy. * have been taking anti-hiv drugs for at least 8 weeks before study entry with no changes in the regimen. * are at least 18 years old. * agree to practice effective methods of birth control. exclusion criteria patients will not be eligible for this study if they: * have an aids-related opportunistic infection (except for genital herpes) within 2 weeks of study entry. * have had another type of cancer within the past 2 years (except for certain types of skin cancer, cervical cancer, or anal cancer). * have a severe chest cold. * have certain other serious medical conditions. * have received certain medications, including chemotherapy, within the past 4 weeks. * abuse alcohol or drugs. * are pregnant or breast-feeding.

Keywords: aids-related opportunistic infections placebos sarcoma, kaposi antineoplastic agents treatment outcome quality of life
the effect of exercise training intensity in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. the research hypothesis is that high intensity exercise training will be superior to moderate intensity on such outcomes in individuals with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * all participants meet the american diabetes association diagnostic criteria for type 2 diabetes. * a physician must consider each participant to be medically stable to participate in this investigation. exclusion criteria: * any individual with a history of a medical condition identified by the american heart association as an absolute contraindication to exercise testing is excluded from this study. * any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation. * any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.
shared care for patients with type 2 diabetes across the primary and secondary health care sector

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to test the effect of a new shared care model for type 2 diabetes care and compare it with a standardized care management program in a specialized hospital-based out-patient clinic. the hypothesis is that participants with type 2 diabetes followed in a shared care program will have a comparable outcome in hba1c to participants receiving standard care.

the prevalence of patients with type 2 diabetes is in growth globally. in order to secure high quality in diabetes care it is necessary to rethink the way in which the care is organized. the investigators want to test a new model of shared care across the interface of primary and secondary care sector for patients with type 2 diabetes who are at risk stratification level 2. based on a national and regional risk stratification model patients can be stratified to three levels according to risk and complexity of treatment: level 1 (uncomplicated), level 2 (intermediate risk) and level 3 (high risk). the objective of the study is to show equal outcomes among the participants being treated in either a shared care program or an established program in a specialized outpatient clinic. the study is a non-inferiority randomized controlled trial. the shared care model will be tested during a period of three years. all participants are offered four medical visits a year. the shared care intervention consists of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at a general practice. the control group is followed with four quarterly visits at the outpatient clinic including an annual comprehensive check-up. the recruitment period spans over approximately 12 months, and participants are randomized to intervention or control group in a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * must be over the age of 18 years * the diagnosis of type 2 diabetes * risk stratification level 2 * capable of speaking and writing in danish * give oral and written consent before entering the study exclusion criteria: * diagnosed with other types of diabetes than type 2 diabetes * risk stratification level 1 or 3 * being pregnant or breastfeeding * having severe co-morbidity with life expectancy less than five years * being under such conditions, that the patient will not be able to show up or go through with the appointments (e.g. moderate to severe dementia and severe psychiatric conditions) * participating in long-lasting interventions (\>2 weeks) that potentially affects the primary outcome in our study or patients participating in studies which include blood sampling amounting to \>5 % of the blood volume two months prior to the randomisation and/or the follow-up visits
travoprost intraocular implant + istent infinite vs. istent infinite alone

Conditions: Glaucoma, Open-Angle

Summary: adult subjects with elevated intraocular pressure who have successfully undergone placement of istent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.


Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension * qualifying iop in the study eye exclusion criteria: * unmedicated (washed out) iop of \>36 mmhg in the study eye * hypersensitivity to travoprost or any other components of the travoprost intraocular implant * vertical cup/disc ratio \> 0.8 in the study eye * best spectacle corrected visual acuity of worse than 20/80 in either eye eye * any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
family and peer involvement in the treatment of anxiety disorders in children

Conditions: Anxiety Disorders

Summary: this study will compare the effectiveness of family- and peer-oriented therapy in treating children with anxiety disorders and will also test for therapy specificity effects and potential mediators of outcome.

data suggest that individual cognitive behavior therapy (cbt) is effective in reducing anxiety disorders in children. the incorporation of parents and peers in a cbt treatment program also has been found to be effective in reducing anxiety symptoms, because a child's environment (i.e., parents, peers) affect the development, course, and outcome of childhood anxiety and functional status. children and their parents will be randomly assigned to one of two treatment conditions: family/parents cbt (fcbt) or peer/group cbt (gcbt) for 14 to 16 weekly sessions. parent-child relationships are the focus of fcbt. parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children. children in the gcbt group will be trained to be more helpful and positive toward other children through role-playing activities. interviews, questionnaires, and behavior observation tasks will be used to assess participants. all participants will be assessed at pretreatment, post-treatment, and at yearly follow-up visits. the first set of hypotheses that will be tested is that fcbt will produce significantly greater specific effects on parenting skills and parent-child relationships than on child social skills and peer-child relationships. gcbt, on the other hand, will produce significantly greater specific effects on child social skills and peer-child relationships than on parenting skills and parent-child relationships. the second set of hypotheses will test whether or not it is the changes that are produced on these variables that mediate treatment response. thus, the second set of hypotheses that will be tested is that parenting skills, parent-child relationships, child social skills and/or peer-child relationships will be significant mediators of treatment response, i.e., anxiety reduction

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for generalized anxiety disorder (gad), social phobia (sp), or separation anxiety disorder (sad) * mean score \>= 4 on the clinician's rating scale of severity * discontinuation of all other psychosocial treatment upon consultation with clinic staff and the service provider exclusion criteria: * dsm-iv criteria for a disorder other than gad, sp, and sad * diagnosis of any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, or schizophrenia and other psychotic disorders * at risk for harm to self or others