Kornimate/medical-research-clean huggingface dataset:
impact of comprehensive intervention on the cardiometabolic risk in children with central obesity (igenoi)obesity

Conditions: Pediatric Obesity

Summary: central obesity, present in the metabolic syndrome (ms), is associated with increased risk of insulin resistance (ri). the aim of the project is to evaluate the protective effect of comprehensive intervention (mediterranean diet + physical activity) in the development of ri in children with central obesity based on genetic and epigenetic markers.

objectives: 1) apply a comprehensive therapeutic nutrition intervention program for monitoring the mediterranean diet (dm) slightly hypocaloric along with increased physical activity in children with central obesity 7-16 years). 2) measure the effectiveness of this program by assessing changes in body composition, lifestyle and biological and molecular parameters (genetic and epigenetic). methodology: test randomized, longitudinal, controlled, two-year intervention field comparing a sample of 120 subjects from 7 to 16 years with central obesity, the effect of two interventions: a) intensive on lifestyle with a reduced calorie dm , physical activity and behavioral therapy, b) non-intensive with healthy diet recommendations following the usual pediatric advice. at 2, 6, 12 and 24 months after follow up changes will be assessed: a) the homa index, body fat, and the cardiovascular risk factors, b) diet, sleep patterns, physical exercise using questionnaires and accelerometers (intervention group), and c) the quality of life. genetic and epigenetic markers will be evaluated by genotyping snps genes related to ri; and the analysis of: a) dna methylation in genes related to insulin resistance, b) expression of micrornas and target genes related to insulin resistance and c) measure the length of telomeres. the therapeutic program will consist of individual sessions and group workshops for the patient and the family.

Eligibility criteria:
inclusion criteria: 1. signed informed consent by the child, parent or guardian. 3. waist circumference above the 90th percentile 4. motivation and willingness to be assigned to either group, and do their utmost to follow protocol assigned. 5. possibility of involvement in days of intensive phase (week 0, 1, 2, 3, 4, 5, 6, 7 and 8) and once a month until 6 months later at 4 months and every 6 months during the second year. exclusion criteria: 1. pre-diabetes 2. presence of other diseases 3. pharmacotherapy 4. monitoring special diets 5. food intolerance 6. regular alcohol consumption 7. drug 8. psychiatric illness or eating disorder 9. people without telephone or internet access
curing atopic dermatits in children with a commerical medical device and maintaining healthy skin by using a new cosmetic product

Conditions: Dermatitis, Atopic

Summary: 1. curing mild atopic dermatis in children with a commerical medical device (bepanthen itch relief cream). 2. maintaining healthy skin by using a new cosmetic bepanthen product or a commercially available cosmetic product


Eligibility criteria:
inclusion criteria: * written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol * male or female babies/children aged between 1 month and 4 years * mild ad presenting a maximum scorad of 25 (at screening and baseline) * acute flare-up phase * local scorad ≥ 5 on the target area (at screening and baseline) * skin type i - iv according to fitzpatrick exclusion criteria: * any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator * known allergies to any of the ingredients of the imps * any other adjuvant therapy for ad (uv therapy, probiotics, homeopathy etc.) within 30 days before baseline as well as during the entire study * any use of another topical emollient or other established treatment for ad during phase 1 (cure phase) and phase 2 (care phase) at the site of flares (ad lesions). exception are usual hygienic products in the nappy area

Keywords: safety efficacy atopic dermatitis cosmetic products
benign thyroid nodules / benign goiter. what subjective problems are improved with an operation and can this be predicted preoperatively?

Conditions: Thyroid Nodule

Summary: nodules in the thyroid gland are common. patients discover these lumps either because of their visible size increase or because of local discomforts such as difficulty swallowing, difficulty breathing or voice changes. the thyroid gland is in close connection with the esophagus, trachea and the vocal nerve. thus, a lump in the thyroid gland can cause pressure symptoms from these organs. in the event of such complaints, patients are referred for investigation. if it turns out that the patient has a lump in the thyroid gland ("goiter"), further investigation is carried out with an ultrasound examination and sampling with a needle from the lump (puncture). at present, most thyroid nodules are examined cytologically, ie the thyroid nodules are punctured with a thin needle and the cells that are obtained are analyzed by a cytologist. the material is graded according to bethesda classification. higher grading is associated with a higher risk that the tuber is malignant. lower grading is associated with a lower probability that the tuber can be malignant. if these patients are operated on, it is usually with the hope that their local ailments improve. we want to investigate which patients who have a lump in the thyroid gland and experience pressure problems experience an improvement after a thyroid operation.


Eligibility criteria:
inclusion criteria: * patients with a thyroid nodule who have local problems and where surgery (hemithyroidectomy) is planned * 18 years or older * bethesda i-iv exclusion criteria: -
effect of oral tramadol administration prior to iud insertion

Conditions: Contraception

Summary: the aim of the study is to evaluate the safety and efficacy of oral tramadol administration in reducing pain during lng- iud insertion in adolescents and young women


Eligibility criteria:
inclusion criteria: * nulliparous adolescents and young women requesting lng-iud insertion exclusion criteria: * parous women, contraindications to lng-iud insertion and allergy or contraindications to tramadol
the clinical impact of integrated behavioral health techniques in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this research is to assess the impact of using lin health to provide virtual long-term follow up care for patients with a diagnosis of fibromyalgia.


Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older. * patient must have a diagnosis of fibromyalgia. * patient must be being seen at the mayo clinic fibromyalgia and chronic fatigue clinic in rochester, mn. * patient must be able to understand and provide informed consent and hipaa authorization * patient must be willing and able to complete all aspects of the study. * patient must be able to speak and read english. exclusion criteria: * patient who is under the age of 18 years old. * patient who is unable to provide informed consent or hipaa authorization. * patient who declines study participation. * patient who is unable to speak english. * patient who is on active cancer therapy. * patient who is actively psychotic or actively suicidal. * patient who is deemed inappropriate to the study by the medical professional.
distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children

Conditions: Pain, Acute; Fear; Anxiety State

Summary: this randomized controlled study was planned to evaluate the effects of distraction methods, using virtual reality or a stress ball, on the emotional appearance, pain, fear, and anxiety associated with the procedure, during the phlebotomy in children aged 6-12 in a private blood collection unit.

h1: there is a difference between the groups in terms of pain, fear, anxiety and emotional appearance scores related to the intervention during the blood draw attempt. a standard approach will be applied to all children. standard approach; giving information about the procedure, the nurse introducing herself, choosing the area together, being with the parent and talking to the child during the procedure, "i'm starting now, i'm cleaning the area, take a deep breath, i'm applying it now, it may hurt a little, you shouldn't move, it will take a very short time, i will cover it with tape " contains. in the virtual reality glasses group, a tourniquet will be attached to the extremity where the intervention will be performed. by wearing virtual glasses, the video will be started. in the stress ball group, before the intervention is applied, the other hand will be given a stress ball and asked to squeeze it. in the control group, communication with the child will continue during the intervention with the questions mentioned above. when the nurse decides on the area where the pict will be performed (the minute will be recorded), she will use the words "i am cleaning the area, take a deep breath, now i am applying the injection, it may hurt a little, you should not move, it will be very short". the intervention will be stopped when the blood draw attempt fails in all groups. 5 minutes after the blood draw attempt, the child will be asked to rate the most painful moment felt during the procedure using the facial expressions rating scale. the child fear scale (cds) and child anxiety scale-state (cas-d) will be given to the child to assess how anxious and frightened he is during the procedure. the child will be asked to mark with a pencil. the emotional appearance scale for children will be evaluated by the nurse after the procedure.

Eligibility criteria:
inclusion criteria: * the age range of children is between 6-12 * the child's consent to voluntarily participate in the study * parent's willingness to participate in the study voluntarily * obtaining consent forms from child and parent exclusion criteria: * the child has a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality. * fever (\>37.5c) and severe dehydration * the child takes analgesics before the blood draw * wearing glasses
fns (femoral neck system) study

Conditions: Femoral Neck Fractures

Summary: a post-market, prospective study to evaluate the reoperation rate of displaced and nondisplaced femoral neck fractures treated with the femoral neck system (fns)™

to evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the femoral neck system (fns)™ at one year post-operation. the femoral neck system (fns)™ represents a new generation of implants designed to improve outcomes in the treatment of femoral neck fractures. these implants offer a fixed angle construct and all of its mechanical advantages with regards to neutralizing shear and providing stability while not exerting a rotational malreduction force on the fracture. the fns system has been shown to compare favorably to traditional fixed angle constructs in a cadaveric model

Eligibility criteria:
inclusion criteria: * the subject must provide written informed consent * the subject must be eighteen (18) years of age or older. * the subject must be willing and able to make all required study visits including one (1) year post-operative follow-up. * the subject must be able to follow instructions. * subject has experienced displaced or non-displaced intracapsular femoral neck fracture exclusion criteria: * subject with fracture occurring more than 7 days prior to the date of surgery * subject has more than one fracture on target extremity. * subject is obese as defined by a body mass index (bmi) \> 45 at the time of surgery. * subject, in the opinion of the investigator, has an emotional or neurological condition that preludes cooperation and compliance with the rehabilitation regimen. * therapy with another investigational agent within thirty (30) days of screening or planned therapy with another investigational agent during the course of the study. * subject has a physical condition that, in the opinion of the investigator, would preclude adequate implant support or impede healing (e.g. blood supply impairment insufficient bone quality or quantity, or an active, local or systemic infection). if this is identified at the time of surgery, the subject will be screen failed. * subject has undergone previous surgery on the target hip. * current systemic therapy with cytotoxic drugs. * subjects with a history of poor compliance with medical treatment. * subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.

Keywords: neck fractures implant failure osteotomy
volar locking plate versus external fixator/cast fixation for the treatment of distal radius fractures

Conditions: Distal Radius Fractures

Summary: aim: osteosynthesis with locking plate/screws has become increasingly popular in recent years. it is the only treatment option which allows immediate postoperative immobilization. however, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. the long-term results of all treatment modalities are equal, which has been shown in numerous studies. however, there are no evidence based studies published yet which look at short-term outcomes. the investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. if that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius methods: group 1: treatment of distal radius fractures with either volar or dorsal locking plates. no fixation postoperatively, immediate rom (range of motion) exercises and usage of the wrist in activities of daily life (adl) allowed. radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. endpoints are time to return to work / return to independency (in older people), rom; grip strength (with jamar dynamometer). outcome scores are dash (disability of arm, shoulder and hand score)and prwe (patient related wrist evaluation). group 2 treatment of distal radius fractures with either an external fixator +/- k-wires or with k-wires and forearm cast or by cast alone. main issue is that the wrist is immobilized for a period of 6 weeks. radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. endpoints are time to return to work / return to independency (in older people), rom; grip strength (with jamar dynamometer). outcome scores are dash and prwe. both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. a power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean dash and prwe scores.


Eligibility criteria:
inclusion criteria: * distal radius fracture * age \> 18 exclusion criteria: * intellectual or mental impairment * \< 18 years of age
comparison of two minimally invasive surgical techniques for hip replacement

Conditions: Osteoarthritis

Summary: comparison of the clinical effectiveness and cost-effectiveness of the mis anterolateral approach (mis watson jones, g3) versus anterolateral mini or posterolateral mini approaches in primary total hip arthroplasty


Eligibility criteria:
inclusion criteria: no contralateral hip symptoms, no major comorbidity exclusion criteria: -
bg9924 in combination with methotrexate for participants with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this phase 2b study is designed to evaluate the efficacy and safety of bg9924 given subcutaneously (sc) versus placebo in participants with active rheumatoid arthritis (ra) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-tnf) therapy.


Eligibility criteria:
key inclusion criteria: * diagnosis of rheumatoid arthritis (functional class i - iii) at least 6 months prior to baseline * methotrexate (10 mg/week to 25 mg/week) \> 3 months prior to day 0 (stable dose \> 4 weeks prior to day 0) * must have had an inadequate response to anti-tnf therapy due to inadequate efficacy key exclusion criteria: medical history * serious local infection or systemic infection within 3 months of day 0 * history (hx) of recurrent infections requiring oral or parental anti-infective treatment * hx of tuberculosis (tb) or positive purified protein derivative (ppd) test during the screening period laboratory tests * clinically significant lab tests at screening; or * positive for hepatitis c antibody or hepatitis b at screening note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: active rheumatoid arthritis (ra)
epanova® compared to lovaza® in a pharmacokinetic, single-dose, evaluation

Conditions: Severe Hypertriglyceridemia

Summary: the objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (epa) and docosahexaenoic acid (dha) in plasma from a single dose of epanova or lovaza during periods of high- and low -fat consumption.


Eligibility criteria:
inclusion criteria: * men or women, aged ≥18. * normal healthy volunteers based on medical history, clinical assessments, and laboratory assessments. * body mass index 25-35 kg/m2. * willingness to maintain current activity level. * willingness to adhere to the therapeutic lifestyle changes (tlc)diet during screening and treatment washout periods. exclusion criteria: * intolerance to omega-3 fatty acids, ethyl esters, or fish. * unable or unwilling to eat the study meals. * use of fish oil, other epa or dha containing supplements, or epa and/or dha fortified foods within 60 days of visit 2, or during the study. * consumption of any fish within 7 days of visit 2, or during the study. * use of flaxseed, perilla seed, hemp, spirulina, or black currant oils within 7 days of visit 2, or during the study. * history of malabsorption syndrome, crohn's disease, acute or chronic pancreatitis, pancreatic insufficiency, small bowel resection. * women who are pregnant, lactating, or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable contraceptive methods. a woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. examples of acceptable contraceptive methods include abstinence, intrauterine device (iud) or double barrier method, oral or injectable contraceptives. * recent history (past 12 months) of drug abuse or alcohol abuse. alcohol abuse will be defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor). * exposure to any investigational product, within 28 days prior to visit 1. * any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.

Keywords: eicosapentaenoic acid docosahexaenoic acid hypertriglyceridemia omega-3 acid ethyl esters omega-3 carboxylic acids epanova lovaza bioavailability pharmacokinetics low-fat meal high-fat meal
study to examine safety, tolerability and pharmacokinetics of intravenous doses and oral dose of gsk233705

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: gsk233705 is being developed for the treatment of chronic obstructive pulmonary disease. this will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of gsk233705. the main objective of the study is to confirm an iv and oral dose for a definitive human radiolabel metabolic study.


Eligibility criteria:
inclusion criteria: * healthy male subjects; * between the ages of 18-55 years, inclusive * body mass index within the range 18.0 to 30.0 kg/m2. * non-smokers * adequate venous access for intermittent cannulation * a signed and dated written informed consent is obtained from the subject * the subject is capable of giving informed consent * available to complete the study exclusion criteria: * any clinically important abnormality identified in the following: at the screening medical assessment * a mean qtc(b) value at screening \>450msec, the qtc(b) of the 3 screening ecgs are not within 10% of the mean, a pr interval outside the range 90-210msec or an ecg that is not suitable for qt measurements * a history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmhg at screening. * a mean heart rate outside the range of 40-90 bpm at screening. * history of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening. * the subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study. * the subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as st john's wort. * the subject has taken: prescription medications within the past 2 weeks prior to dosing, or otc medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the investigator not to compromise their safety or influence the outcome of the study. * the subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing. * the subject has tested positive for hepatitis c antibody, hepatitis b surface antigen or hiv

Keywords: muscarinic receptor antagonist, intravenous infusion, pharmacokinetics healthy subjects, safety, tolerability, anticholinergic, oral dosing,