Kornimate/medical-research-clean huggingface dataset:
efficacy, safety, and tolerability of ambien (zolpidem) in the treatment of children ages 6 to 17 with attention deficit hyperactivity disorder (adhd)-associated insomnia

Conditions: Attention Deficit Hyperactivity Disorder

Summary: there has been an increased interest in the association between adhd and sleep disorders over the past years. a high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in adhd children regardless of whether or not they are receiving stimulant therapy. this study will assess the safety and efficacy of zolpidem in children with adhd associated insomnia.

the study is being conducted in the united states. it consists of 3 segments: * segment a: 2 to 21 day screening period * segment b: 8-week double-blind treatment period * segment c: 1-week follow-up period subjects will have a polysomnography in a sleep lab two times during the study (at baseline and between visit 4-5) and also be required to wear an actigraphy monitoring tool. there will be several questionnaires completed throughout the study: cgi-child, cgi-parent/legal guardian, adhd rating scale-iv, and the pediatric daytime sleepiness scale.

Eligibility criteria:
inclusion criteria: * male or female between the ages of 6 and 17 years, inclusive * children with diagnosed adhd (as defined by the diagnostic and statistical manual of mental disorders, 4th edition, text revision \[dsm-iv-tr\] criteria) * complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep * the sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication. * subjects should be stabilized on all long-term therapy, including treatment of adhd, for at least one month prior to study entry. * subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). abstinence is an acceptable method of birth control for this study. exclusion criteria: * mental retardation * autistic spectrum disorder * a history of sleep apnea * a history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and dsm-iv-tr criteria * current history of substance abuse/dependence * known hypersensitivity to zolpidem or previous adverse experience with zolpidem * pregnant or breast-feeding * current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids

Keywords: child psychology pediatric psychology insomnia sleeplessness
fatty liver and pancreatic steatosis

Conditions: Exocrine Pancreatic Insufficiency; Fatty Liver, Nonalcoholic; Pancreatic Steatosis

Summary: the goal of this observational study is to determine the prevalence of pancreatic steatosis in patients with fatty liver and determine the prevalence of exocrine pancreatic insufficiency (epi) in these patients. participants with fatty liver and metabolic syndrome will undergo fecal elastase measurement and endoscopic ultrasound (eus).

the purpose of this study is to evaluate the association between non-alcoholic fatty liver disease and non-alcoholic pancreatic steatosis and to describe cytokine levels in the context of a global epidemic of obesity and metabolic syndrome, which could represent a new treatment target in previously underdiagnosed patients with pancreatic insufficiency and pancreatic steatosis. patients over 18 years old with a diagnosis of mafld (metabolic dysfunction-associated fatty liver disease) will undergo the following assessments: * exocrine pancreatic insufficiency questionnaire (pei-q) * measurement of weight, height, and abdominal circumference * fecal elastase (fel-1) * pro-inflammatory and anti-inflammatory cytokines in serum * hydrogen and methane breath tests to evaluate small intestinal bacterial overgrowth (sibo) * endoscopic ultrasound with sedation * fibroscan exocrine pancreatic insufficiency (epi) will be defined as a fecal elastase-1 (fel-1) concentration of \< 100 µg/g or fel-1 between 100 and 200 µg/g with alterations in additional pancreatic pathology tests, such as serum albumin, vitamin e, vitamin d, vitamin a, folic acid, iron, transferrin, calcium, magnesium, and/or malnutrition identified through anthropometric measurements conducted by an expert nutritionist. fel-1 ≥ 200 µg/g will be considered normal. additionally, for those patients with fecal elastase levels below 200 µg/g, the following measurements will be conducted: * proteinogram * vitamin e, vitamin d, vitamin a, vitamin k * folic acid, b12 * calcium, magnesium, zinc * iron profile * nutritional assessment with anthropometry for those with exocrine pancreatic insufficiency (epi): * igg4 * alpha-1 antitrypsin * endoscopic ultrasound (eus) with biopsies

Eligibility criteria:
inclusion criteria: * patients over 18 years old with a diagnosis of metabolic dysfunction-associated fatty liver disease (mafld). exclusion criteria: * - alcohol consumption \>20 g/day in women, \>30 g/day in men * chronic hepatitis b or c infection * autoimmune liver diseases: autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis * hereditary hemochromatosis * wilson's disease * alpha-1 antitrypsin deficiency * celiac disease * uncontrolled thyroid disease * active or chronic infectious disease * active cancer or ongoing treatment * chronic renal insufficiency * pregnancy/lactation * insufficient data * patients who do not complete follow-up

Keywords: fatty liver pancreatic steatosis metabolic syndrome
"cancersensor" metastasis resection

Conditions: Metastatic Colorectal Cancer

Summary: observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically-confirmed metastatic colorectal cancer; * 0 to 3 prior chemotherapy lines; signed informed consent; * good understanding of the protocol and of the follow-up; * estimated life expectancy exceeding 3 months; * at least one measurable metastatic lesion (recist criteria); * performance status (who) of 0 to 2; * good haematological, hepatic and renal functions. exclusion criteria: * poor haematological, hepatic or renal functions; * uncontrolled chronic disease; * serious unhealed wound, ulcer or fracture within the previous month; * clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion; * pregnancy or breast-feeding during the previous month; * transmeridian trip of more than 4 time zones within the prior 2 weeks; * person with legal restriction to participate into clinical research, according to the current law in france.

Keywords: colorectal cancer metastatic control urine nucleosides surgery general anesthesia scheduled for surgery
nonpharmacological methods in heel stick pain

Conditions: Pain Management; Newborn Pain

Summary: in the present study, the randomized controlled and experimental design is used because it was aimed to determine the effects of two different warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick intervention on pain levels and duration of crying in healthy term newborns. study hypotheses are; hypothesis 1. using the thermophore pad warming method in newborns before heel prick reduces the newborn's pain level. hypothesis 2. using the warm towel warming method in newborns before heel prick reduces the newborn's pain level. hypothesis 3. using the thermophore pad warming method in newborns before heel prick reduces the duration of crying. hypothesis 4. using the warm towel warming method in newborns before heel prick reduces the duration of crying

heel prick, intervention performed to take blood sample from the heel, which is frequently performed in newborns, is a more painful intervention than are other methods of taking blood samples. in several studies, it has been indicated that the use of various non-pharmacological methods such as sucrose administration, breastfeeding, skin-to-skin care, acupressure, swaddling, positioning, non-nutritive sucking, foot reflexology, vibration, laser acupuncture, warming the baby's heel reduce infants' pain during heel prick. this study is a prospective, randomized and controlled trial. in this study aim, was aimed at determining the effects of two different heel warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick on healthy term newborns' pain levels and duration of cryingin newborns will be examined. the minimum number of newborns to be included in the study was calculated as 150 using the g\*power (3.1. 9.7) program (margin of error: 5%, confidence interval: 0.95, power: 0.80). the 150 newborns in the sample were randomly assigned into the following three groups in equal numbers via an internet-based program (http://www.randomizer.org): control group (n = 50), thermophore-warming group (n = 47) and warm towel-warming group (n = 50). data collection tools to collect the study data, the "descriptive information form", "follow-up form", and "neonatal infant pain scale" were used.

Eligibility criteria:
inclusion criteria: * having been born at 38-42 weeks of gestation, * having a birth weight of 2500 g and above, * having a 5-min apgar score of 7 and above, * having stable health, * having been fed within an hour before the intervention, being calm and not crying before the intervention, * having a postnatal age of 24-72 hours, and * undergoing heel prick for the first time exclusion criteria: * parents with any mental problems * infants with any chronic disease and congenital anomalies.
comparison of two intraocular gas injection techniques in macula hole surgery

Conditions: Macular Holes

Summary: to undertake a prospective randomized clinical trial of vitrectomy and gas tamponade to treat macular hole, utilizing a small amount of undiluted c3f8 (perfluoropropane) versus a large amount of diluted c3f8 versus a small amount of undiluted sf6 (sulfur hexafluoride) versus a large amount of diluted sf6.


Eligibility criteria:
inclusion criteria: * pseudophakia * without previous vitreoretinal surgery * diagnosed with a full-thickness macula hole on the optical coherence tomography exam. * duration of symptoms less than 6 months * inform consent exclusion criteria: * ocular trauma * allergy to any of the products used in the study, * need to travel by plane in the first 60 postoperative days * myopia over 6 diopters or axial diameter over 26 mm * retinal dystrophies * retinal detachment * abnormal eye shape * glaucoma * diabetic retinopathy or other eye comorbidities.

Keywords: macular holes injections, intra-ocular gases
change in body weight during treatment of advanced colorectal cancer

Conditions: Cancer, Colorectal; Chemotherapy Effect; Weight Loss; Prognosis

Summary: colorectal cancer (crc) is a significant and growing health burden in hong kong. according to data from hong kong cancer registry, crc ranked the first in incidence and the second in mortality, with around 5,000 new cases diagnosed and more than 2,000 cancer-related mortality in 2014. the investigators aim to evaluate the association between serial weight change during first line treatment and outcomes in patients with metastatic crc.

studies have suggested that exposure to a greater number of chemotherapeutic agents is associated with better survival in metastatic colorectal cancer. multiple factors might affect body weight during treatment. cancer-related symptoms can impair quality of life and appetite. cachexia syndrome affects around 50% of colon cancer patients and is characterized by cancer-induced catabolism with involuntary weight loss (fat and muscle), patients have increased lipolysis and change in skeletal muscle metabolism, including increased energy expenditure at rest and protein degradation, and decreased protein synthesis. besides these disease factors, treatment related side effects are common causes of weight loss, such as inability to ingest or digest food effectively due to nausea, vomiting, and malaise. based on these factors and the hypotheses between tumour control and weight gain, monitoring the serial weight change can have practical value.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of colorectal origin * stage iv disease with systemic treatment * estimated life expectancy \>3 months * adequate organ functions exclusion criteria: * eastern cooperative oncology group performance status 3 or above * pregnancy * human immunodeficiency virus infection and acquired immune deficiency syndrome (hiv/aids) * past medical history of another cancer

Keywords: cancer survival chemotherapy weight
effect of collaborative infertility counseling on coping strategies and marital satisfaction

Conditions: Fertility Issues

Summary: effect of collaborative infertility counseling on coping strategies and marital satisfaction among women undergoing in vitro fertilization: a randomized control trial


Eligibility criteria:
this study will include a non-probability purposive sample of 136 infertile women undergoing ivf recruiting from the outpatient clinics according to the following inclusion criteria: * age 20 to 45 years * having a general health score below 28, * can read and write, exclusion criteria include: * psychiatric problems, * previous assisted reproductive technology failure, * leave the intervention for any reason and * women suddenly experience severe traumatic or psychological events.
a study of evacetrapib (ly2484595) in combination with atorvastatin in japanese participants with primary hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the main purpose of this study is to evaluate the efficacy and safety of the study drug known as evacetrapib when administered in combination with atorvastatin for 12 weeks in japanese participants with primary hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * must be treated with atorvastatin 10 mg/day for at least 30 days prior to study initiation. * japanese outpatients who are diagnosed with primary hypercholesterolemia with ldl-c levels (measured by a direct method) that meet the following criteria. (participant categories are based on the definition in japan atherosclerosis society 2012 guidelines.) * category i: 160 mg/deciliter (dl)≤ldl-c * category ii: 140 mg/dl≤ldl-c * category iii: 120 mg/dl≤ldl-c * secondary prevention: 100 mg/dl≤ldl-c * have triglycerides (tg) ≤400 mg/dl. * have hdl-c \<100 mg/dl. exclusion criteria: * participants on ldl apheresis or plasma apheresis. * participants with secondary hypercholesterolemia or homozygous familial hypercholesterolemia. * any planned angiography. if angiography is planned, participants may be screened and enrolled after all such planned procedures are completed. * history of any of the following conditions \< 90 days prior to study initiation * acute coronary syndrome (unstable angina, acute myocardial infarction) * symptomatic peripheral arterial disease * invasive treatment of carotid artery disease * ischemic stroke or transient ischemic attack (tia) * intracranial hemorrhage * history of abdominal aortic aneurysm. * participants with a history of intolerance/hypersensitivity to ezetimibe or statins. * have systolic blood pressure (sbp) \> 160 millimeters of mercury (mm hg) or diastolic blood pressure (dbp) \> 100 mm hg. * have a hemoglobin a1c ≥8.4% (national glycohemoglobin standardization program). * during the study period, participants who plan to use, are likely to require, or unwilling or unable to stop with adequate washout any prescription, over the counter (otc) medication, supplements or health foods with the intent to treat serum lipids (ldl-c, hdl-c, tg) including but not limited to these classes of drugs: statin (except for atorvastatin 10 mg), ezetimibe, bile acid sequestrant, eicosapentaenoic acid (epa) and docosahexaenoic acid (dha). participants taking probucol, fibrate or nicotinic agents within 8 weeks before study initiation are excluded from the study. * have been exposed to cholesteryl ester transfer protein (cetp) inhibitors (for example, anacetrapib or dalcetrapib).
sunitinib malate schedule 4/2 vs. sunitinib malate continuous dosing as first-line therapy for metastatic renal cell cancer (rcc)

Conditions: Carcinoma, Renal Cell

Summary: this trial has two parts. the purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. this part is currently closed to enrollment. the purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. the trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.


Eligibility criteria:
inclusion criteria: * advanced renal cell carcinoma of clear cell origin or a component of clear cell histology. * measurable disease exclusion criteria: * prior systemic therapy of any kind for advanced renal cell cancer * history of brain metastases * uncontrolled hypertension
comparing the inter-dental brush to dental floss

Conditions: Gingivitis

Summary: the study's purpose is to find an easy and effective alternative to dental floss for those persons who cannot or choose not to dental floss so that they can maintain and/or achieve optimal oral health. the study hypothesis is that the inter-dental brush is as effective as dental floss for removing plaque from between the teeth and for reducing bleeding gums in persons with gingivitis, but may be easier to use and thus encourage daily home use.

purpose: to determine if the interdental brush is just as effective at removing plaque and reducing bleeding gums between the teeth as dental floss. rationale: many people find dental floss difficult to use and thus, do not floss daily to maintain oral health and prevent gum disease. these individuals may find the interdental brush easier to use and may be motivated to use it daily for optimal oral health. study design: study subjects will use the dental floss and the interdental brush for 12 weeks. plaque and bleeding scores will be measured before the study begins (week 0), mid-way (week 6), and at the end of the 12 weeks. all study subjects receive a teeth cleaning prior to the first measurements and oral hygiene instructions on how to floss and use the interdental brush. subjects will also answer 4 short questions about their product preference and ease of use. study subjects: 32 healthy adult volunteers with bleeding gums. to be included in the study, subjects require 8 bleeding sites, 4 areas that can accommodate the interdental brush, dexterity to dental floss, and willingness to come for 4 study visits. exclusion criteria include smokers because this can affect the bleeding scores; individuals with braces (orthodontia) which affects plaque levels; individuals using chlorhexidine which is a prescription strength mouthwash used to treat moderate to severe gum disease; pregnant women; and those individuals requiring antibiotics prior to dental appointments. enrolled study subjects receive a teeth cleaning (value $180), $75 for completing the study, and all study related supplies.

Eligibility criteria:
inclusion criteria: * adults * minimum of 4 interproximal areas that can accommodate a minimum 0.6 mm interdental brush width * minimum of 8 interproximal bleeding sites upon stimulation * dexterity to use manual waxed dental floss * able to attend all 4 study visits exclusion criteria: * require premedication with antibiotics prior to dental therapy * use chlorhexidine or over-the-counter mouthwash during the study * smoke * have orthodontia

Keywords: interdental self-care aids plaque bleeding gums
effect of vitamin d replacement on bone healing in mini-dental implants

Conditions: Deficiency, Vitamin D

Summary: 1. title 2. executive team 3. research line 4. summary 5. research problem 6. justification 7. literature review 8. objectives 9. materials and methods 10. dissemination of knowledge generated 11. schedule of activities 12. budget 13. references 14. annexes

this is a clinical research study, characterized by a randomized, double-blind, placebo-controlled clinical trial. background: vitamin d replacement could aid in the osseointegration of dental implants. objective: to evaluate the effect of vitamin d replacement on osseointegration of dental implants in humans. materials and methods: twenty individuals with hypovitaminosis d underwent dental miniimplants and randomized to two equal groups for treatment with vitamin d (5000 iu / day) or placebo for 2 months. after two months, the miniimplants will be removed and prepared for histomorphometric analysis, which will evaluate bone implant contact in percentage. testing the hypothesis that the contact between bone and implant and the bone density in the threaded area in the test group is higher than in the control group. test t will be used to compare the differences between the groups.

Eligibility criteria:
inclusion criteria: * patients of both sexes; * no medical, temporary or intra-oral contraindications; * good general health; * need of implant in the maxilla in the posterior region (with a minimum of 5 mm of bone height visualized radiographically) or in mandible in posterior region; * with vitamin d deficiency / deficiency (considering serum level of ≥ 15 ng / ml at ≤ 25 ng / ml). exclusion criteria: * medical, temporary or intrabuccal contraindications; * smokers; * use of corticoid; * post-operative of bariatric surgery; * bone height less than 5mm; * need for maxillary sinus lift; * vitamin supplementation d.

Keywords: implants vitamin d osseointegration histomorphometric