Kornimate/medical-research-clean huggingface dataset:
night balance for positional obstructive sleep apnea syndrome (posas)

Conditions: Obstructive Sleep Apnea (OSAS)

Summary: posas can be treated with cpap however there is now evidence from a few studies that night balance is effective in posas. night balance seems to be better accepted than cpap so we would like to examine if we could find similar results in routine clinical work and especially we would like to confirm the subjective effects with objective measures i.e. a reduction in ahi in the supine position during sleep.

primary aim: efficacy and adherence of night balance in posas versus no therapy after 2 months (sleep supine). secondary aim: efficacy and adherence of night balance in posas after a 6 months period (sleep supine and compliance and ahi). nigh balance is a vibrator and a belt that vibrate when laying supine so that after a few days you will not sleep supine.

Eligibility criteria:
inclusion criteria: * ahi supine ≥ ahi non-supine x 2, * ahi supine ≥ 10 * ahi non-supine \<10 * 10 -90 % sleep time in supine position * daytime tiredness and/or disturbed sleep and/or snoring exclusion criteria: * not able or willing to cooperate * age \<18 years * central sleep apnea * night or shifting work * severe chronic heart failure or severe copd * a medical history of known causes of tiredness by day or severe sleep disruption (insomnia, plms, narcolepsy) * seizure disorder * a known medical history of mental retardation, memory disorders or psychiatric disorders * the inability to provide informed consent * pacemaker * pain in joints or shoulder * other reasons unable to sleep in lateral positions. * pregnant females or females that plan pregnancy in study period (problems sleeping supine) * breastfeeding females in study period (other reasons for disturbed sleep) * plan weight reduction in study period * plan to quit smoking in study period

Keywords: positional obstructive sleep apnea syndrome (posas) obstructive sleep apnea syndrome (osas) apnea-hypnea index (ahi) sleep questionnaire positional sleep apnea belt adverse events compliance
breakfast consumption in preschoolers: satiety, diet quality and memory

Conditions: Lack of Satiety; Dietary Modification; Memory Deficits; Obesity

Summary: one important factor determining school performance is the consumption of breakfast. while research has shown that older children perform better in school after consuming breakfast, there are little data for preschool-age children. consuming breakfasts with different macro- and micronutrient contents may have different effects on performance, which may be associated with variations in satiation and satiety during and after the different breakfasts. in addition, children who consume breakfast have better diet quality than children who skip breakfast. the investigators will conduct a community based, randomized, crossover trial in 4-5 year old children over 7 weeks to examine the short-term effect of feeding preschoolers three different intervention breakfast types: high protein, high-fiber, or high protein and high fiber compared to a usual breakfast served at the preschool. the investigators expect that the children consuming any of the three experimental breakfasts will consume less overall calories and have better diet quality and memory performance compared to children who have the usual breakfast. the investigators hypothesis is that preschoolers will experience the highest level of satiety as well as highest level of overall diet quality when they consume the combined high-protein and high-fiber based breakfast foods. this study will be conducted at bauer family resources in lafayette as these are the sites of head start programs, which are preschools for children from low-income families. children from families of low income are more likely to have poor diet quality and poor school performance compared to children from families with higher incomes. therefore, this population is most in need of this type of intervention.


Eligibility criteria:
inclusion criteria: * 4-5 year old children attending head start centers in lafayette, in. males and females of all racial and ethnic background are included. exclusion criteria: * no digestive disorders, food allergies, or kidney disease. children cannot be taking medication that would affect appetite.

Keywords: satiety satiation diet quality memory obesity protein fiber
behaviors of children ages 15 months to five years around microwave ovens

Conditions: Scald Burn Injuries

Summary: the purpose of this study is to assess the typical behavior of children ages 15 months to five years around a microwave oven. the uch burn and complex wound center has observed scald burn injuries in young children operating and/or removing hot liquids from microwave ovens. the knowledge we hope to gain is the developmental age that a child is able to open and/or operate a microwave oven safely. this work may influence future microwave oven design to protect young children from microwave-related scald burn injuries. these injuries have resulted in visits to the emergency room, stays in the hospital and debridement and skin grafting procedures in the operating room.


Eligibility criteria:
inclusion criteria: * a microwave oven in the child's home environment, * age appropriate development, * intact visual acuity, and * english speaking. exclusion criteria: * developmental delay, * non-english speaking.

Keywords: typical development microwave children behavior
mouse allergen and asthma intervention trial

Conditions: Asthma; Mouse Allergy; Mouse Allergen Exposure

Summary: the maait is a randomized, controlled trial of a home intervention to reduce mouse allergen exposure in mouse allergic children with asthma and mouse allergen exposure. participants will be randomized to either the integrated pest management (ipm) group or the education group. the ipm group will receive professional mouse abatement, education, two hepa filters, allergen-proof mattress and pillow encasements, and targeted cleaning. the education group will receive education about ipm at the beginning of the trial and then after completion of the trial, will receive the ipm intervention. participants will be followed for 12 months.


Eligibility criteria:
inclusion criteria: * persistent asthma * exacerbation, previous 12 months * evidence of mouse sensitization * high levels of mouse allergen in home * ages 5-17 years exclusion criteria: * intermittent asthma * no exacerbation in previous 12 months * not sensitized to mouse * low or undetectable mouse allergen in home * other lung disease aside from asthma

Keywords: asthma mouse allergen environmental intervention
inofolic nrt and the metabolic syndrome

Conditions: Metabolic Syndrome; Postmenopausal Disorder

Summary: a prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in nih atp iii). after a written informed consent, women will be randomly treated for 6 months with hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly eighty post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40 treated with myo-inositol 2 g twice per day and forty treated with placebo for six months. the investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance.

inclusion criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to atp iii, 2001. at least 3 of following 5 criteria must be present: 1. waist circumference \> 88 cm 2. triglycerides \> 150 mg/dl 3. hdl-cholesterol \< 50 mg/dl 4. fast glycemia \> 110 mg/dl 5. systolic blood pressure \> 135 mmhg. diastolic \> 85 mmhg - exclusion criteria:1) post-menopausal women with less than 12 months from the last menstruation 2) less than 3 criteria according with atp iii 3) tsh \> 3.5 4) in treatment with drugs lowering glycemia or cholesterol 5) allergy to cocoa

Eligibility criteria:
inclusion criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to atp iii, 2001. at least 3 of following 5 criteria must be present: 1. waist circumference \> 88 cm 2. triglycerides \> 150 mg/dl 3. hdl-cholesterol \< 50 mg/dl 4. fast glycemia \> 110 mg/dl 5. systolic blood pressure \> 135 mmhg. diastolic \> 85 mmhg - exclusion criteria: 1. post-menopausal women with less than 12 months from the last menstruation 2. less than 3 criteria according with atp iii 3. tsh \> 3.5 4. in treatment with drugs lowering glycemia or cholesterol 5. allergy to cocoa

Keywords: menopause metabolic syndrome myo-inositol insulin resistance cocoa polyphenols isoflavones
anti-vascular endothelial growth factor (anti-vegf) alone versus ozurdex given every 3 months for treatment of persistent diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: to determine if there is visual benefit with ozurdex treatment every three months compared to monthly anti-vegf alone, in subjects with persistent diabetic macular edema. the investigator hypothesizes more frequent administration of ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (oct) compared to the use of anti-vegf alone.

statistics throughout this study referred to the number of eyes rather than the number of subjects. subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.

Eligibility criteria:
inclusion criteria: 1. male of female age 18 years or older 2. type 1 or type 2 diabetes 3. best corrected visual acuity (bcva) score of \>24 and \<78 letters 4. history of at least 3 anti-vegf intravitreal injections over the past 5 months 5. presence of macular edema defined as central subfield thickness of \>340 microns on cirrus oct exclusion criteria: 1. anti-vegf intravitreal treatment in the last 4 weeks 2. intravitreal steroid treatment in the last 8 weeks or ozurdex in the last 4 months 3. pan retinal photocoagulation (prp) or focal laser in the last 4 months 4. active iris neovascularization 5. any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result 6. uncontrolled systemic disease 7. known history of intraocular pressure (iop) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications 8. current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit 9. female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception 10. any condition or reason (including inability to read early treatment diabetic retinopathy study (etdrs) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study 11. patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. 12. aphakia or pseudophakia with anterior chamber intraocular lens 13. hypersensitivity to any components of ozurdex or avastin
duloxetine for chronic depression: a double-blind study

Conditions: Dysthymic Disorder; Depressive Disorder NOS

Summary: the investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. duloxetine (trade name cymbalta) was recently approved by the fda for the treatment of major depression. the investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia). chronic depression, lasting two or more years, often causes significant suffering and impairment. the investigators study involves a 6 to 10 week double-blind initial phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). after the initial phase, a 12-week continuation phase will begin, during which all subjects can be treated with an fda-approved antidepressant medication. eligible subjects may also receive mri scans, to help the investigators understand how antidepressants work in treating depression.

this is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. participants can have dysthymic disorder (dysthymia), or depression, not otherwise specified (depression nos). the first 10 weeks (acute phase) are double blind, placebo-controlled, and the second 12 weeks (continuation phase) is open-label and all subjects will receive active medication. tests of cytokine functioning will be performed and analyzed for treatment and placebo effects. in addition, a subset of patients will be enrolled into an magnetic resonance imaging (mri) sub-study, in which a variety of brain imaging techniques (including anatomical mri, functional mri (fmri), mr spectroscopy, and diffusion tensor imaging) will be performed at baseline and week 10. duloxetine responders will have a third mri performed at week 22.

Eligibility criteria:
inclusion criteria: * age 20 to 75 years (ages 20 to 60 for mri sub-study) * diagnosis of dysthymic disorder (chronic depression) or depression nos * minimum of 2 years duration of current episode of depression exclusion criteria: * current major depression * diagnoses including delirium, dementia, bipolar disorder, schizophrenia * substance abuse or dependence in the past 6 months * pregnant or nursing women * serious risk of suicide

Keywords: dysthymia dysthymic disorder chronic depression chronic low-grade depression atypical depression minor depression depression nos depression depressive disorder mood disorder unipolar depression low-grade depression
treatment with zoledronic acid in patients with breast cancer, multiple myeloma, and prostate cancer with cancer related bone lesions

Conditions: Breast Cancer; Multiple Myeloma; Prostate Cancer

Summary: patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with iv zometa in a 15 minute infusion. pain will be evaluated, as well as time in chair, quality of life and safety of zometa.


Eligibility criteria:
inclusion criteria * signed informed consent * greater than 18 years of age * proof of breast cancer, multiple myeloma or prostate cancer * diagnosis of at least one cancer-related bone lesion * if patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception * ecog performance status of 0,1 or 2 * ability to read, understand and write english or spanish language * normal renal function * corrected serum calcium equal to or greater than 8mg/dl exclusion criteria * clinically symptomatic brain metastases * hypersensitivity to zometa or other bisphosphonates * pregnant or lactating

Keywords: bone lesions breast cancer multiple myeloma prostate cancer bone metastases pain
efficacy study of paclitaxel-eluting balloon, -stent vs. plain angioplasty for drug-eluting stent restenosis

Conditions: Heart Disease; Ischemia; Restenosis

Summary: the purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "limus"-eluting stents, (les).

the use of drug-eluting stents (des) has led to a drastic reduction of restenosis rates compared to bare metal stents (bms), but 5% to 10% of patients receiving des are still in need of revascularization of the treated vessel. two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus a9 and pimecrolimus. data regarding the optimal treatment of in-des-restenosis is very limited. implanting a new des for in-des-restenosis has been reported to be associated with re-restenosis rates as high as 43%. several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (peb) for de-novo lesions and bms-restenotic lesions. the objective of this randomized trial is to assess the hypothesis, that peb are non-inferior to paclitaxel-eluting-stents (pes) for restenosis in "limus"-eluting-stents (les), and both, peb and pes, are superior to plain angioplasty in patients with restenosis after initial les implantation.

Eligibility criteria:
inclusion criteria: 1. patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of les in native coronary vessels. 2. written, informed consent by the patient or her/his legally-authorized representative for participation in the study. 3. in women with childbearing potential a negative pregnancy test is mandatory. exclusion criteria: 1. age \< 18 years. 2. cardiogenic shock. 3. acute st-elevation myocardial infarction within 48 hours from symptom onset. 4. target lesion located in the left main trunk or bypass graft. 5. target lesion located in small vessel (vessel size \< 2.0 mm). 6. malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. 7. severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min). 8. contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome. 9. pregnancy (present, suspected or planned) or positive pregnancy test. 10. previous enrollment in this trial. 11. patient's inability to fully comply with the study protocol.
a controlled study of an herbal topical patch in treating osteoarthritis (oa) of the knee

Conditions: Osteoarthritis, Knee

Summary: an evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.

this is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of herbal patch in subjects with oa knee pain. the overall objective of this study is to evaluate the efficacy and safety of the patch in relieving oa knee pain.

Eligibility criteria:
inclusion criteria: * male or female between 40 and 70 years of age * medically cleared to participate by a site affiliated physician following a physical * history of, or current diagnosis of, oa of the knee * evidence of idiopathic oa of at least one knee * subject assessment of oa pain in target knee 40 - 75 mm (on the 100 mm vas inclusive) in the index knee, on the womac pain composite subscale at visit 1 * subject assessment of oa pain in non-index knee (if applicable) is ≤ 20mm * subject global assessment of oa condition (5 pt categorical scale, 1 = very good to 5 = very poor) of grade 3-5 (i.e. fair, poor or very poor) * evidence of idiopathic oa of at least one knee as defined by the american college of rheumatology classification (acr) of oa of the knee exclusion criteria: * grade 1 or grade 4 severity of the index knee based on the kellgren and lawrence radiographic criteria * pain greater than 20 mm on the vas in the non-index knee (either at rest or with movement) * prior injection or arthroscopy of study knee within 3 months * crystalline-induced synovitis (e.g. gout, pseudo gout, nonsteroid arthritis, hydroxyapatite deposit), acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, fibromyalgia, systemic lupus, erythematosus collagen vascular disease or other types of inflammatory arthritis in the index knee * pain in either knee is of neurological origin * an injury or surgery to the same body region within the prior 6 months or a lifetime history of 3 or more injuries/surgeries to the injured body region * signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits * other criteria that - in the opinion of the investigator - may jeopardize the safety of the subject or the study results.

Keywords: osteoarthritis pain herbal medicine topical administration
predictive risk factors for pancreatic fistula grade c after pancreaticoduodenectomy

Conditions: Disease of Pancreatic Head or Periampullary Lesions to Require Pancreaticoduodenectomy

Summary: pancreatic fistula (pf) grade c, defined by the international study group of pancreatic fistula (isgpf) is associated with a life-threatening complication after pancreaticoduodenectomy(pd). therefore, the aim of this study is to clarify the risk factors for grade c pf by japan and taiwan cooperative project.

pancreatic fistula (pf) grade c, defined by the international study group of pancreatic fistula (isgpf) is associated with a life-threatening complication after pancreaticoduodenectomy(pd). the rate of grade c pf has been reported 2.5-6%, however, it is critical complication after pd. a large number of enrolled patients will be needed to clarify the risk factors for grade c pf. therefore, this study design is prospective large observational study at multi-center in japan and taiwan.

Eligibility criteria:
inclusion criteria: 1. disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy 2. age: 20 years or older 3. ps (ecog performance status scale) 0-1 at the time of enrollment 4. ability to understand and the willingness to sign a written informed consent document exclusion criteria: 1. patients with severe respiratory disorder required oxygen inhalation 2. patients with severe liver dysfunction 3. patients with chronic renal failure with dialysis 4. patients who are unfit for this study as determined by the attending physician