Kornimate/medical-research-clean huggingface dataset:
role of carbohydrate modification in weight management among obese children

Conditions: Childhood Obesity

Summary: the purpose of this study is to test the hypothesis that a low-carbohydrate diet and a low-glycemic load diet will improve body mass index and result in more body fat loss than a control diet among overweight children ages 7 to 12. in addition this study is also designed to test the safety of diets with modified carbohydrate content as compared to a conventional weight management diet among younger overweight children.

the treatment of pediatric obesity supported by the medical community is a moderate restriction in calories by modifying intake of fat and simple sugars, along with an increase in energy expenditure through more physical activity. however, this approach is associated with only limited success. as a result, overweight children and adolescents are seeking alternative approaches to weight management, such as diets that modify the type and amount of carbohydrates. however, at this time there is limited data on the safety and efficacy of these diets, particularly with younger children. this study is a controlled clinical trial that compares the safety and efficacy of a low carbohydrate and reduced glycemic load diets to a more standard dietary intervention for the management of pediatric obesity (i.e. portion-controlled, moderate fat, high carbohydrate diet). this study will involve 150 overweight children (ages 7 to 12) who will be randomly assigned to one of the three diet groups for 12 months. the effects of each diet will be determined by measuring changes in anthropometric measures (body weight, height, body mass index, waist circumference, body composition), other cardiovascular risk factors (blood pressure, fasting lipid profile, fasting glucose and insulin, and inflammatory markers of cardiovascular disease), and measures of psychological well-being and mental status. the results of this study will provide needed information to the public in their quest for safe, effective, and health-promoting weight management strategies for obese children. such information is vital if we are to address the obesity epidemic in the united states.

Eligibility criteria:
inclusion criteria: * age 7-12 years * body mass index \>95th percentile and bmi z-score no greater than 2.65 * normal fasting blood glucose of less than 100 mg/dl * age-appropriate cognitive and behavioral skills * absence of developmental or physical disabilities * capability to function independently in group exercise sessions * commitment of parent/guardian to attend scheduled meetings for 12-month period exclusion criteria: * active cardiac, pulmonary, renal, liver, or gastrointestinal disease (pancreatitis, cholelithiasis, inflammatory bowel disease), diabetes, untreated thyroid disease, hypertension, hyperlipidemia * chronic infections * uncompensated or labile mental illness * chronic or intermittent use of corticosteroids * specific medications that may alter lipid, glucose, bone metabolism or appetite

Keywords: childhood obesity weight management dietary interventions cardiovascular disease risk factors
expanded access to veliparib

Conditions: Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound; Triple Negative Breast Cancer (TNBC); High Grade Serous Ovarian Cancer; Patients Requiring Veliparib Suspension Formulation

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to veliparib prior to approval by the local regulatory agency. availability will depend on territory eligibility. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. eap is also available for other indications where there is reasonable scientific basis for efficacy.

expanded access

Eligibility criteria:
inclusion criteria: * the patient has relapsed/refractory disease and exhausted all standard treatments. * the patient has documented breast cancer (brca), brca associated ring domain (bard), or partner and localizer of breast cancer (palb) or other acceptable deoxyribonucleic acid (dna) mutations. exclusion criteria: * the patient is eligible for a poly adenosine diphosphate ribose polymerase (parp) inhibitor clinical trial. * the patient has previously received a parp inhibitor for the same disease.

Keywords: expanded access pre-approval access compassionate use special access program named patient basis special access scheme
xylitol for otitis media

Conditions: Otitis Media With Effusion

Summary: this is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3 years, with a diagnosis of otis media with effusion (ome) based on examination by a provider at a duke- affiliated otolaryngology clinic.

the primary purpose of this study is to evaluate the efficacy of intranasal xylitol in young children with otitis media with effusion as measured by the resolution of middle ear effusion based on physical examination and tympanometry at 6-, 12-, and 18 and 24-weeks post-treatment. eligible subjects will be randomly assigned to receive either intranasal xylitol spray or a nasal saline spray placebo and will be observed for 24-weeks following initiation of daily xylitol spray or placebo. the primary efficacy endpoint, the time to middle ear effusion resolution with and without the xylitol nasal spray, will be analyzed using either a two-sample t-test or non-parametric wilcoxon test, depending on whether the time is normal or non-normal. risks include epistaxis, diarrhea, and allergic reaction. serious adverse events are not anticipated.

Eligibility criteria:
inclusion criteria: * between 6 months and 3 years of age. * clinical diagnosis of ome. treated at duke for the above condition. * ability of parent/guardian to be compliant with at-home nasal spray administration. exclusion criteria: * history of immunodeficiency or an immunologic disorder that predisposes to frequent infections. * history of prior pressure-equalization (pe) tube placement and the tubes are still in place. * active or recent (\<1 month prior to screening) middle ear disease, including but not limited to: cholesteatoma, tympanic membrane perforation, congenital external or middle ear abnormalities or malformations. * history of previous otologic surgery including tympanoplasty, and/or mastoidectomy. * previous use of intranasal sprays other than normal saline, including intranasal steroids, and/or xylitol within 1 month prior to screening. * any other clinically significant illness or medical condition, per pi discretion, that would prohibit the subject from participating in the study. * subject has previously been randomized to a trial of xylitol. * parent/guardian is unable to administer the study nasal spray. * parent/guardian is unable to read, write, and understand english. * parent/guardian is unable to provide legally effective consent.
casinomacropeptide and satiety

Conditions: Lack of Satiety; Excess Intake of Macronutrients; Appetite Disorders

Summary: assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle.

assessing 5 different milk derived proteins versus placebo for appetite regulation and satiety, delivered via shake vehicle. subjects will attend a 5 hour post-prandial study day. subjects will keep food records 1 and 3 days prior to study visit, day of visit, and day after visit; food to be weighed using study provided dietary scale.

Eligibility criteria:
inclusion criteria: * healthy * unrestrained (score ≤ 10 on the eating inventory (ei) questionnaire, stunkard and messick 1985) * women * 18 years of age * consume a low/moderate protein diet (12-20% protein energy). * meet bmi criteria of 19 to 24 kg/m2 or 29 to 34 kg/m2, inclusive. exclusion criteria: * women who score ≥ 10 on the beck depression inventory (bdi, beck and beamesdorfer 1974) * women who score ≥ 30 on eating attitudes test (eat, garner and garfinkel 1979), * have current or past (previous 1 year) medical conditions that may interfere with any of the outcomes of this study. * weigh less than 110 lbs * are currently or have been modifying diet or exercise patterns to gain or lose weight in previous 60 days * have unstable body weight (fluctuations of ≥ 5 kg in 60 day period) * are excessive exercisers or trained athletes * taking any medications that would affect appetite or any other study-described endpoint will also be excluded. * allergies or intolerances to foods consumed in the study. * smoker * pregnant/lactation

Keywords: satiety food intake regulation appetite regulation dairy protein
clinical trial of ultra-high dose methylcobalamin for als

Conditions: Amyotrophic Lateral Sclerosis

Summary: to examine the clinical efficacy and safety of ultra-high dose (50mg, im, twice a week) methylcobalamin in retarding the progression of symptoms in amyotrophic lateral sclerosis (als) patients, we enroll als patients diagnosed by updated awaji criteria within 12 months after the clinical onset. first they are followed for 12 weeks with amyotrophic lateral sclerosis functional rating scale-revised (alsfrs-r) scores, and only those who exhibit drops of 1-2 points are allowed to enter into the test period. a total of 128 patients are randomized and the half having placebo. they are blindly evaluated for drops of alsfrs-r in 16 weeks, as the primary outcome. after this, all subjects receive methylcobalamin.


Eligibility criteria:
inclusion criteria: treatment and ole phase: * als patients within 12 months after clinical onset at the entry * diagnosed based on updated awaji criteria: definite, probably or laboratory supported probable * decline of alsfrsr being 1 or 2 during observation period of 12 weeks * japanese clinical severity scale 1 or 2 * those who can visit the participating medical centers tsunagi phase: - the subjects for the tsunagi phase are patients with als who are continuing the administration of this drug at the time of approval, and have obtained consent for the transition to the tsunagi phase. exclusion criteria: treatment and ole phase: * those who have tracheostomy * those who had nippv * %fvc\<60% * those who have chronic obstructive pulmonary disease (copd) * those who have symptoms and signs of b12 deficiency * those who had edaravone less than 4 weeks prior to entry * those who changed the schedule and dosing of riluzole * those who have dementia * those who have the possibility of pregnancy * those who have serious respiratory or cardiac diseases * those who have malignancies * those who participated other clinical trials within 12 weeks * those who have allergies to b12 and related compounds tsunagi phase: not applicable.

Keywords: als motor neuron disease lou gehrig's disease
a study to measure the effect of a toothpaste containing proteins and enzymes and a fluoride toothpaste on gingival health

Conditions: Gingival Inflammation; Dental Plaque

Summary: this study is a double-blind, randomised, parallel group efficacy study. a minimum of 240 healthy female and male participants aged 18-70 years will be enrolled onto the study according to the inclusion/exclusion criteria. the accepted participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. dental assessments of gingival condition and plaque level will be conducted after 4, 13 and 26 weeks of product use at the study site.


Eligibility criteria:
inclusion criteria: * be in good general health. * be willing and physically able to carry out all study procedures. * be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form. * have at least 20 natural teeth without subgingival calculus including 5 teeth (excluding 3rd molars) in each quadrant, which can be assessed. * have mean gingival index (gi) score between 1.0 and 2.0 (1.0 ≤ mean gi ≤ 2.0) and mean plaque index (pi) ≥ 1.5 at screening and baseline. * not have had a scale and prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study. * be willing to use only the test products for 6 months, after brushing with the products on site. * brush teeth twice daily (once in the morning and once at night). exclusion criteria: * pregnant or breast feeding mothers. * subjects who participated in gum health study within 3 months prior to screening. * current participation in any other cosmetic trials, any dental clinical trials or clinical trials. * subjects who have used gum health products in the 4 weeks prior to screening. * obvious signs of untreated caries or significant periodontal disease, which in the opinion of the study dentist, will affect either the scientific validity of the study or if the participant was to participate in the study would affect their wellbeing. * full or partial dentures wearers. * current orthodontic treatment. * smokers or those who have a recent smoking history, including e-cigarettes. * diabetics. * medical condition and/or regular use of any medication which might affect the outcome of the study, as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs within 4 weeks of screening. * taking dietary supplements (e.g. multivitamins, antioxidants, fish oils, etc.). * vegetarians and vegans. * allergic to any ingredient of study products. * the subject is a unilever employee or a member of the study team. * any participant who, in the judgement of the investigator, should not participate in the study.
clinical study of endovascular interventional surgical instrument control system and related consumables in lower extremity arteriosclerosis occlusive lumen

Conditions: Peripheral Arterial Disease

Summary: this trial was a prospective, multicenter, single-group design. to undergo endovascular treatment of lower extremity arteriosclerosis obliterans after the subjects were selected and enrolled, the surgeons used the endovascular interventional surgical instrument control system developed by shanghai aopeng medical technology co., ltd. and the consumables of the endovascular interventional surgical instrument control system for the interventional hand instrumentation (guide wire, catheter, stent, balloon) for remote delivery, manipulation, and withdrawal

this study will verify the safety and effectiveness of the device in human peripheral vascular diseases, and verify 1. the degree of precision of its operation 2. the function of reducing radiation

Eligibility criteria:
inclusion criteria: * meet all the following criteria to be included in the group. 1. age: 18 years old or above, regardless of gender. 2. suffering from arteriosclerosis obliterans of lower limbs, it has the indication of endovascular treatment. 3. volunteer to participate in the test and sign the informed consent form. exclusion criteria: * general criteria: if any of the following criteria is met, it cannot be included in the group. 1. pregnant or lactating women, or women of childbearing age with positive pregnancy test results. 2. the target vessels were treated by arterial bypass grafting. 3. subjects participated in other clinical trials within 3 months before the screening period. 4. allergic history or contraindication of antiplatelet drugs, anticoagulants, anesthetics, contrast agents, scaffold materials and their coating drugs. 5. severe infection that is difficult to control. * vascular criteria: according to the cta judgment of the diseased vessels, if any of the following criteria is met, they can not be included in the group. 1. perforation, dissection or aneurysm of the diseased vessel or the proximal vessel of the diseased vessel. 2. the investigator believed that the vascular conditions were not suitable for the use of the test medical device.

Keywords: robot peripheral arterial
radiation therapy to prevent brain metastases in patients with previously treated extensive-stage small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. radiation therapy to the brain may be effective in preventing brain metastases. it is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases. purpose: randomized phase iii trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

objectives: * compare the incidence of, and time to, symptomatic brain metastases in patients with previously treated extensive stage small cell lung cancer treated with prophylactic cranial irradiation vs no further therapy. * compare the quality of life and survival of these patients. * determine the toxicity of this regimen in these patients. * determine the health economics associated with this study. outline: this is a randomized, multicenter study. patients are stratified according to participating center and performance status. patients are randomized to 1 of 2 treatment arms. * arm i: within 5 weeks after completion of prior chemotherapy, patients undergo prophylactic cranial irradiation once daily for 5-12 days. * arm ii: patients receive no further therapy after completion of prior chemotherapy. quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months thereafter. projected accrual: a total of 287 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * cytologically or histologically confirmed small cell lung cancer * documented extensive disease before the initiation of chemotherapy * responsive disease after 4 to 6 courses of initial chemotherapy * no more than 5 weeks since completion of prior chemotherapy * no brain or leptomeningeal metastases patient characteristics: age: * 18 to 75 performance status: * who 0-2 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no other prior or concurrent malignancy except skin cancer or carcinoma in situ of the cervix * no psychological, familial, sociological, or geographical condition that would preclude study compliance prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics endocrine therapy: * no concurrent corticosteroids radiotherapy: * no prior radiotherapy to the brain * no prior radiotherapy to the head and neck surgery: * not specified

Keywords: extensive stage small cell lung cancer
paricalcitol improves anemia of inflammation

Conditions: Anemia

Summary: anemia of inflammation (ai) is a common comorbidity in hemodialysis patients. paricalcitol is a selective vitamin d receptor activator with potential benefits on anti-inflammatory cytokines expression. the paricalcitol for the secondary hyperparathyroidism control may improve ai decreasing erythropoietin stimulating agents (esas) dosage.

anemia of inflammation and secondary hyperparathyroidism (shpt) are two common clinical complications in patients with chronic kidney disease. eryptosis (accelerated red blood cell death) is a novel mechanism associated with renal anemia and several factors such us iron, erythropoietin and klotho (anti-aging hormone) deficiency have been associated with this process. the use of the paricalcitol may inhibit pro-inflammatory cytokines expression, especially interleukine-6, which is one of the most important cytokine associated with the pathogenesis of the ai. if the use of the paricalcitol for the shpt control may exert direct influence on the erythropoiesis process is not known.

Eligibility criteria:
inclusion criteria: * age \>= 18 years. * patients with ckd on hemodialysis of any etiology.. * hemoglobin between 9 and 12g/dl at least 12 weeks before enrollment in the study. * hemoglobin plasma levels stabilized: hb variation \<or = 1 g / dl for the two months prior to inclusion in the study. * patients with anemia of renal etiology. * esa treatment with stable doses for 2 months prior to baseline.stable dose esa definition: variation \<or = 3000ui/week. * iron status: ferritin\> 200 ng / ml and/or transferrin saturation index (ist):\> = 20%). * kt / v \>= 1.2 ( daugirdas-2nd generation). * calcium concentrations between : 8.4 to 9.5 mg / dl and phosphorus: 3.5-5.5 mg / dl. * vitamin d 25oh normal \>= 15 ng / ml (patients with lower levels will be supplemented with calcifediol 16000 iu / bi-weekly for 6 weeks in selected patients). * pthi concentrations\> = 150 pg / ml and \<or = to 300 pg / ml. * patients who accept their inclusion in the study and sign informed consent. exclusion criteria: * epoetin beta dose \> 18,000 iu / weekly. * pregnant woman of childbearing age or gestational wishes or not to use adequate contraception ( the ogino-knaus contraceptive method is considered unsuitable). * active bleeding episode or history of transfusion the 2 months prior to baseline. * patients with non-renal causes of anemia: malignancies, folic acid or vitamin b12 deficiency, hemoglobinopathies, hemolysis, pure red cell aplasia secondary to erythropoietin. * patients treated with the selective vitamin d receptor activator in the 3 months prior to inclusion in the study. * acute or chronic symptomatic: heart failure (iv-nyha), infection or inflammatory disease, uncontrolled hypertension that requires the suspension of epoetin beta, thrombocytopathies, aplastic anemia. * immunosuppressive treatment with uncontrolled hemoglobin level * allergy to paricalcitol or any of its components.

Keywords: renal disease erythropoiesis erythropoietin stimulating agent iron klotho selective vitamin d receptor activation
tnf-alpha inhibition in crps: a randomized controlled trial

Conditions: CRPS; Chronic Regional Pain Syndrome

Summary: studying the effects of etanercept (an anti-tumor necrosis factor alpha) on early chronic regional pain syndrome (crps). our hypothesis is that etanercept will improve patient symptoms if given in early crps.


Eligibility criteria:
inclusion criteria: 1. female pediatric chronic regional pain syndrome (crps) patients with unilateral crps of the lower extremity, ages 10-17 years of age. 2. patients must meet crps type i diagnostic criteria and have current evidence of edema, and a temperature difference between the affected and contralateral limb ≥1.0°c. 3. duration of symptoms less than 4 months. exclusion criteria: 1. active malignancy or history of malignancy. 2. active infection. 3. history of tuberculosis (tb) or tb exposure. 4. pregnancy. 5. concomitant disease causing immunocompromise. 6. concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or crohn's disease. 7. poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder. 8. hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age. 9. evidence of or history of demyelinating disease.