Kornimate/medical-research-clean huggingface dataset:
nutrition and soccer for pediatric overweight and obesity

Conditions: Obesity; Overweight

Summary: this study will examine whether two months of youth soccer, combined with a single brief behavioral/nutritional intervention, can reduce bmi in 5th grade overweight or obese females.

female overweight and obese public school students will be recruited during the summer of 2006 based on fitnessgram testing done by graduate students at msu during their prior (4th grade) school year. after receiving informed consent from parent/child, the subjects will be checked for height/weight and other screening criteria, then exposed to 2005 my pyramid for kids, "tips for families" information, and watch a short 8 minute dvd that discusses the importance of exercise and fitness by way of interviewing two club level female soccer players of equivalent age. subjects will then be randomly assigned to fall youth soccer in starkville, or spring youth soccer, after first phase data collection occurs in november, 2006.

Eligibility criteria:
inclusion criteria: * obese or overweight 4th grade public school student in starkville exclusion criteria: * unable to run or physical disease or disability

Keywords: obesity overweight
early treatment diabetic retinopathy study (etdrs)

Conditions: Blindness; Diabetic Retinopathy

Summary: to evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness. to help determine the best time to initiate photocoagulation treatment in diabetic retinopathy. to monitor closely the effects of diabetes mellitus and of photocoagulation on visual function. to produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.

etdrs was a multicenter, randomized clinical trial designed to evaluate argon laser photocoagulation and aspirin treatment in the management of patients with nonproliferative or early proliferative diabetic retinopathy. a total of 3,711 patients were recruited to be followed for a minimum of 4 years to provide long-term information on the risks and benefits of the treatments under study. the eligibility criteria for the etdrs were designed to include a broad range of macular edema severity, from a few small hard exudates within a disc diameter of the fovea with normal visual acuity to extensive cystoid spaces with a visual acuity of 20/200. all study patients had one eye randomly assigned to immediate photocoagulation and the other eye to deferral of photocoagulation until high-risk proliferative retinopathy developed. during followup, additional photocoagulation was allowed for any degree of macular edema within the eligibility range, but additional photocoagulation was required only for edema involving or threatening the center of the macula. the term "clinically significant macular edema" was coined to designate this level of severity. the trial use of aspirin therapy was based on clinical observation and on aspirin's possible mechanisms of action. previous observations of diabetic patients who were taking large doses of aspirin for rheumatoid arthritis showed that the prevalence of retinopathy in this group was lower than the prevalence that would be expected in the diabetic population at large. evidence suggested that diabetic patients have altered platelet aggregation and disaggregation, which may contribute to the capillary closure seen in retinopathy. this abnormality is reversed by aspirin in vitro . however, because of aspirin's other possible mechanisms of action and its well-known side effects, such as allergic, idiosyncratic, and intolerance reactions, the use of this therapy in the etdrs was carefully controlled and monitored.

Eligibility criteria:
men and women between the ages of 18 and 70 years with moderate or severe nonproliferative diabetic retinopathy or mild proliferative retinopathy in both eyes, with no previous photocoagulation treatment, and with visual acuity of 20/40 or better (20/200 or better if macular edema is present) were eligible for this study.
herbal pralines - oral health

Conditions: Periodontitis; Gingivitis

Summary: this randomized, double-blinded, placebo-controlled two-arm, parallel group clinical trial is designed to evaluate the impact of the consumption of two herbal pralines containing 200 mg nitrate on clinical signs of gingival inflammation (bleeding on probing) without an accompanied professional mechanical plaque removal.


Eligibility criteria:
inclusion criteria: * age 18 to 65 years, * minimum of 20 % of the measure points showing a manifest bleeding after probing, * no periodontal maintenance therapy within the past 4 months, * a minimum of 10 remaining natural teeth exclusion criteria: * history of drug / alcohol abuse, * systemic intake of antibiotics \< 6 months prior to the study period, * regular use of anti-inflammatory drugs, * regular use of antibacterial mouthwashes, * known allergic reactions to any ingredient in the experimental pralines * mean arterial blood pressure mad \<80mmhg * known allergies and intolerances to any of the ingredients of the experimental pralines
investigation of the efficacy and tolerability of a cosmetic product with onabotulinumtoxin a in the treatment of facial lines

Conditions: Wrinkles; Photoaging; Fine Lines

Summary: this randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate the procedure-pairing of onabotulinumtoxina with a peptide anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as compared to placebo. a total of 29 subjects completed study participation.

this randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial was conducted to evaluate procedure pairing of a peptide anti-aging serum with onabotulinumtoxin a in the treatment of periorbital facial wrinkles when used over the course of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to moderate photoaging. efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at rest and at maximum smile for each side. investigator and subject tolerability, self-assessment questionnaire and visia photography will be completed at baseline, weeks 4, 8 and 12. a total of 29 subjects completed study participation.

Eligibility criteria:
inclusion criteria: 1. female subjects must be between 35-60 years of age. 2. female subjects of childbearing potential must be willing to use a form of birth control during the study. 3. subjects with fitzpatrick i-vi photo skin type. 4. subjects must have moderate to severe crow's feet facial wrinkles (score 4-7 on 0-9 scale) using modified griffith's 10-point scale. 5. subjects must have moderate to severe crow's feet fine lines (score 4-7 on 0-9 scale) using modified griffith's 10-point scale. 6. subjects may have mild to moderate photo-aging (score 3-6 on 0-9 scale) secondary to physiologic aging, hormonal influences, and environmental stressors. 7. subjects must have no skin disease in the facial area being evaluated. 8. subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation. 9. subjects must be willing to provide verbal understanding and written informed consent exclusion criteria: 1. female subjects who are pregnant, breast feeding, or planning a pregnancy. 2. subjects with severe overall photo damage (score 7-9 on 0-9 scale) as determined by the investigator. 3. subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products or to the botulinum toxin. 4. subjects who are unwilling or unable to comply with the requirements of the protocol.

Keywords: anti-aging serum onabotulinum toxin a botox
preoperative frailty and postoperative prognosis in the elderly after major surgeries

Conditions: Frailty; Age Problem; Surgery

Summary: elderly people often have comorbidities. however, there could be a big difference in their health status. frailty is considered to be relevant to adverse outcomes. some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (cga) of the elderly can improve clinical outcomes, but there has been no valid assessment established in china. therefore it is important to design a research and help to solve this problem.

with an aging population and the improvement of medical technology, the number of elderly patients who need surgery is gradually increasing. elderly people often have comorbidities, malnutrition, and other conditions leading to an increased risk of anesthesia. what's more, there could be a big difference in the health status of the elderly with the same age. frailty is considered to be highly prevalent with increasing age and to confer high risk for adverse outcomes. a complete evaluation of elderly patients before surgery may help improve the prognosis. some studies have found that preoperative frailty assessment and comprehensive geriatric assessment (cga) of the elderly can improve clinical outcomes, but there has been no valid assessment established in china. in this study, we plan to use a comprehensive preoperative frailty assessment and follow up for 30 days after surgery to explore the effect of preoperative frailty on postoperative complications in the elderly after major surgeries. to better evaluate the postoperative complications, we choose comprehensive complication index (cci), which integrates all complication of the clavien-dindo classification and offers a metric approach to measure morbidity.

Eligibility criteria:
inclusion criteria: * aging at least 65 years old. * scheduled for major surgery in peking union medical college hospital . * understand and be willing to participate in this research, and can provide written informed consent. exclusion criteria: * underwent major surgery within the last month. * can't complete the scale evaluation because of lower limb disability or severe knee osteoarthritis and other conditions that affect walking or climbing stairs. * with mental or neurological disorders and unable to cooperative with investigators. * reject to sign the informed consent.
efficacy of acetylcysteine in patients undergoing surgery for otosclerosis

Conditions: Otosclerosis

Summary: in otosclerosis, one of the tiny bones of the middle ear is unable to move normally. sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. the disorder is usually treated by an operation where the bone is replaced by a prosthesis. this restores hearing at low sound frequencies. at high frequencies, surgery is less effective. the smaller effect at high frequencies is probably caused by surgically induced inner ear damage. animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. it is not known whether the drug has similar effects in humans. this study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.


Eligibility criteria:
inclusion criteria: * otosclerosis where surgery is planned * air / bone gap larger than 20 db * normal middle ear status exclusion criteria: * hypersensitivity to acetylcysteine * deafness on the other ear * stapedotomy previously performed on the ear * pregnancy * asthma
effect of omalizumab on expression of ige receptors in adults with severe, inadequately controlled allergic asthma

Conditions: Asthma

Summary: the aim of this study is to evaluate the expression of ige high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting beta-2 agonist.

double blind placebo controlled study to assess the expression of ige on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week omalizumab treatment.

Eligibility criteria:
inclusion criteria: * adults aged \>= 18 years. * patients with severe persistent allergic asthma with the following characteristics: * fev1 (forced expiratory volume in one second) \<80% of predicted. * frequent daily symptoms (\>=4 days/week on average) or nocturnal awakening (\>=1/week on average). * multiple severe asthma exacerbations: either \>=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year. * despite a high dose inhaled corticosteroid \>1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting b2-agonist. * with an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (rast). * total serum ige level \>= 30 to \<=700 iu/ml and suitable serum total ige level and weight according to xolair dosing tablets. exclusion criteria: * age \< 18 years. * smoking history \> 20 pack years. * patients who have had an asthma exacerbation during the 4 weeks prior to randomization * history of food or drug related severe anaphylactoid or anaphylactic reaction * elevated serum ige levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin e syndrome, wiskott-aldrich syndrome or allergic bronchopulmonary aspergillosis). * patients with active cancer, suspicion of cancer or any history of cancer. * pregnant women. * known hypersensitivity to omalizumab or to one of its components. * patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the fceri expression). * patients who had participated in a clinical trial in the past 3 months.

Keywords: asthma, anti-immunoglobulin e, omalizumab, ige receptors
complete mesocolon excision vs locoregional lymphadenectomy in sigmoid colon cancer (cmell)

Conditions: Colorectal Cancer; Sigmoid Cancer

Summary: a randomized, controlled clinical trial comparing lymphadenectomy with extended inferior mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.


Eligibility criteria:
inclusion criteria: * patients undergoing programmed surgery for laparoscopic sigmoid colon cancer. * age ≥ 18 years and \<80 years. * histology of adenocarcinoma or adenoma without chemotherapy or neoadjuvant radiotherapy. * any t, any n, m0. * intention of resection r0. * informed consent signed by the patient and the investigator. exclusion criteria: * colorectal tumor with histology other than adenocarcinoma or adenoma. * colon cancer located in the right colon, transverse, splenic or non-sigmoid left colon. * metastatic disease (m1). * history of colorectal cancer surgery, different from a local excision. * inflammatory bowel disease with anatomopathological confirmation. * patients with psychiatric illness, addiction or any disorder that impedes the understanding of informed consent. * inability to read or understand any of the languages of the informed consent (catalan, spanish). * another synchronous malignant disease. * emergency surgery.

Keywords: complete mesocolon excision sigmoid cancer colorectal cancer
comprehending atopic risk elements

Conditions: Atopic Dermatitis

Summary: skin barrier impairment and familial atopy have been implicated as crucial risk factors for the development of atopic dermatitis (ad). additional risk factors have been explored, including gestational weight, height, age, familial smoking habits, proximity to urban centers and others. however, a comprehensive study focusing on the entire spectrum of risk factors has yet to be undertaken. such a study could enable predictive capabilities able to inform medical professionals as to a newborn's inherent risk to develop ad, and potentially recommend appropriate preventative modalities to prevent or delay disease onset.


Eligibility criteria:
inclusion criteria: 1. a healthy newborn delivered in a hospital setting more than 24 hours prior to enrollment \& less than 120 hours prior to enrollment 2. term and near term newborns born between 34+0 and 42+0 weeks gestational age 3. mothers must be aged \>18 years 4. parents' ability to complete questionnaire(s) at defined times throughout study duration 5. parents or legal guardian provide informed written consent exclusion criteria: 1. preterm birth prior to 34+0 weeks gestation 2. less than 12 hours out of the incubator 3. neonate has undergone major surgery or intends to undergo major surgery in the coming 14 days 4. neonate has an existing widespread skin condition that would make the detection and/or assessment of eczema difficult 5. neonate has been administered oral or parenteral antibiotics from birth until study enrollment 6. neonate has a serious health issue which, at parent or investigator discretion, would make it difficult for the neonate or parents to take part in the trial 7. any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
hawaii patient reward and incentives to support empowerment

Conditions: Diabetes Mellitus

Summary: the purpose of this randomized controlled trial (rct) study is to examine the extent that financial incentives when combined with diabetes evidence-based practices, improve self-management and biometric measures for adult diabetic medicaid recipients with an hba1c of ≥ 6.5 at enrollment. the study will also evaluate the cost-effectiveness of the program. specific aims: 1. evaluate whether financial incentives for completing american diabetes association (ada) recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve primary biometric outcomes. 2. evaluate whether financial incentives for completing ada recommended tests, exams, health education, biometric outcome goals, and vaccinations will improve diabetes patients' self-management as assessed by summary of diabetes self-care activities measure (sdsca) and 36-item short form health survey (sf36v2). 3. evaluate the extent to which financial incentives for healthy behaviors reduce the cost of health care utilization.

diabetes is the seventh leading cause of death in the united states (oecd 2013). it is also known that certain populations are at greater risk for diabetes. in hawaii, diabetes disproportionally affects native hawaiians and pacific islanders as they are three times more likely to be diagnosed with diabetes. in addition, in 2010 the u.s. department of health and human services office of minority health reported that native hawaiians/pacific islanders in hawaii were 5.7 times as likely as caucasians living in hawaii to die from diabetes(office of minority health, 2010). in order to address the challenges that chronic diseases impose on individuals and the health care system the centers for medicare \& medicaid services (cms) is assessing the impact of incentivizing patients to increase self-care and disease management. previous studies have demonstrated that monetary incentives have been associated with an improvement in behavioral outcomes, most notably when the incentive is received immediately following the targeted behavior (volpp, k.g., et.al., 2008; mitchell, m.s., et.al., 2013). cahill et al. (2008) showed that economic incentives were tied to smoking cessation and led to a decrease in relapse within a year. our study seeks to build on these findings and determine whether financial incentives may provide a way to improve diabetes self-management. data: electronic data (labs, outcomes) - january 1st, 2013 through december 31, 2015 electronic data (claims) - january 1st, 2011 through december 31, 2015

Eligibility criteria:
inclusion criteria: 1. clinically diagnosed with diabetes mellitus 2. 18 years of age or older 3. medicaid recipient 4. at recruitment has an hba1c level of ≥ 6.5 5. at recruitment is receiving care coordination at kaiser permanente hawaii exclusion criteria: 1. current pregnancy - gestational diabetes 2. end-stage renal disease 3. does not speak english

Keywords: incentives, diabetes, medicaid, health behavior, cost effectiveness
alzheimer patients and the snoezelen program

Conditions: Dementia

Summary: to determine the connection between social withdrawal and sensory deprivation in elderly clients with alzheimer's type dementia (i.e. how providing sensory stimulation might reduce social withdrawal).

the snoezelen concept or program was originally thought up in holland and comes from two dutch words meaning to "sniff and doze". it was first introduced in the netherlands in the 1970's. the first room was introduced in snoezelen examines how a group of people react to an area that is private, relaxed and one that they trust. this program will bring out one's sense of taste, touch, smell, sight and hearing just by being in a specially designed room. trust and relaxation will be looked at by those people with developmental disabilities (those that learn at a slower rate). snoezelen originated with the belief that everyone needs nerve pulses (senses). inside a snoezelen room you will find, dimmed lights, a relaxed atmosphere and pleasant surroundings, soothing sounds, intriguing aromas, tasty puddings, candies, interesting light effects (fiber optic light spray), comfortable seating, opportunities for interaction and engagement, sense of control over environment, tactile objects (awareness box), bubble tube, solar projector wheel, water fountain, massage pillow, massage tube, tranquility and solitude. the snoezelen room is an environment in which the primary senses (see, hear, taste, touch) are stimulated all to create an environment that is both relaxing and stimulating. the benefits of snoezelen change per person but may include some of the following: * increased resident and caregiver communication * increased awareness and understanding of the environment the snoezelen idea: client-controlled, safe comfortable atmosphere and freedom from pressure. sensory deprivation (loss) the average person touches 300 different surfaces every 30 minutes. the average person with a profound disability will likely touch 1-5 surfaces in the same time frame.

Eligibility criteria:
inclusion criteria: * residents living at rideaucrest home (long term care facility in kingston, ontario); * residents having a mini mental state exam with a score of 15 to 27 reflecting mild to moderate dementia; * male or female over 65 years of age; * resident who are able to leave the terrace; * resident who are not actively participating in life enrichment programs; * able to provide informed written and signed consent by resident or substitute decision maker. exclusion criteria: * suffering from severe life threatening illness with a reasonable expectation of death within the next six month; * severe mental disorder in the opinion of the investigator (i.e. bipolar, schizophrenia); * no recent change in medication(s) during the past four weeks prior to the project; * other non-alzheimer-type dementia; * residents who suffer from epilepsy.

Keywords: dementia