Kornimate/medical-research-clean huggingface dataset:
preference of protein intake and fto rs1558902 gene polymorphism among women obese

Conditions: Obesity Adult Onset

Summary: the concept personalized gene-based nutrition combines genetic information with specific dietary intake that is crucial in managing obesity. obesity experienced by adult women is generally caused by inapproriate diet and sedentary lifestyle. variations in the fat mass and obesity-related gene (fto) has been linked with susceptibility to obesity, but diet seems to change the relationship. a single nucleotide polymorphism (snp) in the fat mass and obesity-associated gene (fto) is a potent predictor of human obesity. higher protein diets were more appropriate than standard protein diets, and frequently recommended as a weight loss plan as it prevents the loss of lean tissue mass. nevertheless, high intakes of proteins may adversely affect metabolic functions. multi studies have explored associated fto polymorphisms with obesity in different populations. however, the contribution of the fto common variants to obesity is controversial in asian people, some studies showed rs1558902 was statistically associated with bmi, but other results reported fto gene is not statistically associated with obesity. given the diversity of asian populations, the investigators generated a hypothesis whether relations between preference protein intake and fto rs1558902 gene polymorphism exist in selected indonesian obesity women

the sample size was calculated based on the difference in the proportion of variation of the gene fto rs1558902 allele a between obese participants, which previous study estimated to be approximately 6% for populations from malaysia. using a power of 80% and a level of significance of 5%, the investigators required 100 obese participants. bmi and body fat which were assessed by seca body analyzer (seca 201). blood samples were collected after a 12-h minimum fast by prodia laboratory for dna isolation and biochemical analysis

Eligibility criteria:
inclusion criteria: * body mass index \> 25 kg/m2 * waist circumference \> 80 cm exclusion criteria: * chronic disease * have pregnancy * consume diet supplement, drugs

Keywords: woman obese fto-gen rs1558902 protein intake
rsv-mva-bn vaccine phase i trial, intranasal application in adults.

Conditions: Respiratory Syncytial Virus Infections

Summary: a total of 96 subjects will be recruited into 5 groups. each subject will receive either two vaccinations with mva-bn-rsv vaccine or placebo.


Eligibility criteria:
inclusion criteria: * signed and dated an informed consent form and hipaa. * subjects without symptomatic cardiopulmonary and/or metabolic disease. * body mass index (bmi) ≥ 18.5 and ≤ 34.9. * negative human immunodeficiency virus antibody test (anti-hiv), hbsag and hcv virus. * electrocardiogram (ecg) without clinically significant acute findings. * wocbp must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination. exclusion criteria: * history of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial * active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum * pregnant or breast-feeding women. * history or current clinical manifestation of any serious medical condition. * history of or active autoimmune disease. * known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type i. * knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * history of anaphylaxis or severe allergic reaction to any vaccine. * chronic systemic administration defined as more than 14 days of \> 5 mg prednisone per day

Keywords: rsv vaccines respiratory syncytial virus vaccines
patient centered assessment and substance use disorder treatment study (pcast)

Conditions: Substance Use Disorders

Summary: california counties are in the process of implementing a centers for medicare and medicaid services medicaid 1115 substance use disorder (sud) demonstration. the demonstration requires that patients be assigned to addiction treatment settings and levels of care systematically, using comprehensive biopsychosocial assessments and guided by the american society of addiction medicine (asam) patient placement criteria. rti international, a nonprofit research institute, and university of california los angeles (ucla) integrated substance abuse programs have been awarded a contract from the patient centered outcomes research institute (pcori) to study the effects of the asam implementation in california. the california 1115 sud demonstration provides a unique opportunity to learn about the benefits and challenges resulting from system-wide implementation of asam criteria. the study will involve surveying patients in counties that are using the asam criteria and in counties that have not yet adopted the asam criteria. medicaid patients receiving addiction treatment will be offered the opportunity participate in the study and to be surveyed about their experiences in treatment. the study will also analyze data from the california outcomes management system (caloms) and conduct interviews with providers, patients, and policymakers in the state. the results of the study will help inform california's efforts to continually improve its addiction treatment systems to better meet the needs of it communities. this study will also produce important and useful information to patients seeking treatment for addiction, and their providers, sud system administrators, and payers.


Eligibility criteria:
inclusion criteria: * individuals age 19 or older * receiving treatment for addiction in specialty addiction treatment programs licensed in california who are medicaid beneficiaries. exclusion criteria: * less than 19 years old * not receiving treatment for addiction in specialty addiction treatment programs licensed in california * not medicaid beneficiaries

Keywords: patient-centered outcomes research institute (pcori) american society of addiction medicine (asam) substance use addiction treatment rti international ucla
multiple dose pharmacokinetics of lcz696 and its metabolites in subjects with severe renal impairment vs. matched healthy subjects with normal renal function

Conditions: Pharmacokinetics; Renal Impaired; Healthy Volunteer

Summary: an open label, parallel-group study to determine multiple dose pharmacokinetics of lcz696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function


Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: lcz696 pharmacokinetics
observational study in parkinson's disease of the primary care population of patients treated with pramipexole

Conditions: Parkinson Disease

Summary: the primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from parkinson's disease (so called 'primary care' population). the secondary objectives were: * evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease. * evaluate the reasons for choosing pramipexole as treatment. * identify the patient profiles determining the choice of dose of pramipexole prescribed


Eligibility criteria:
inclusion criteria: * patients suffering from idiopathic parkinson's disease and treated with pramipexole for at least two months, examined in consultation exclusion criteria: * patient refusing to take part * patient taking part in a clinical trial
bioflow iii satellite-italy orsiro stent system

Conditions: Coronary Artery Diseases

Summary: clinical evaluation of the orsiro less in subjects requiring coronary revascularization with drug eluting stents (des). 500 subjects will be enrolled in this registry. the sample size maybe increased in order to reach the subgroup sizes (diabetes, small vessel, ami and cto).

for the majority of coronary artery disease (cad) treatment with percutaneous transluminal coronary angioplasty (ptca) provides high initial procedure success. however, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. the reported incidence of restenosis after ptca ranges from 30 to 50%. such rates of recurrence have serious economic consequences. bare metal stents (bms), designed to address the limitations of ptca, reduced the angiographic and clinical restenosis rates in de novo lesions compared to ptca alone and decreased the need for cabg. bms substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures. the invention of drug eluting stents (des) significantly improved on the principle of bms by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neontimal hyperplasia. the introduction of des greatly reduced the incidence of restenosis and resulted in better safety profile as compared to bms with systemic drug administration. these advantages and a lower cost compared to surgical interventions has made des an attractive option to treat coronary artery disease. therefore this observational registry has been designed for the clinical evaluation of the orsiro less requiring coronary revascularization with des. results will contribute to the collection of clinical evidence for the clinical performance.

Eligibility criteria:
inclusion criteria: * symptomatic coronary artery disease * subject signed informed consent for data release * subject is geographically stable and willing to participate at all follow up assessments * subject is ≥ 18 years of age exclusion criteria: * subject did not sign informed consent * pregnancy * known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for pci, stainless steel, sirolimus or contrast media * planned surgery within 6 months after pci unless dual antiplatelet therapy will be maintained * currently participating in another study and primary endpoint not reached yet

Keywords: international multicenter observational registry orsiro drug eluting stent (des) stenting treatment of coronary artery disease coronary revascularization percutaneous coronary intervention (pci) stemi nstemi ischemia angina acute myocardial infarction (ami) small vessels chronic total occlusion (cto)
action observation training for functional performance in children with cerebral palsy

Conditions: Cerebral Palsy (CP); Physical Functional Performance

Summary: this study is a randomized control trial and aims to determine the effects of action observation on balance and mobility in patients with cerebral palsy compared to training without action observation.

effetcs of action observation will be assessed for functional performance which includes the parameters of balance and mobility. spastic cp children agd 5-12 will be recruited in the study. the participants would be assessed through modified ashworth scale, gmfcs, pediatrics balance scale and gmfm-88 . informed consent will ne taken after which the participants will be recruited into the two groups, where one group will recieve training with action observation and other group will receive training without action observation. baseline and post-treatment measurements will be taken for analysis.

Eligibility criteria:
inclusion criteria: * age 5-12. * spastic cp. * modified ashworth scale spasticity score 0-2 * gmfcs level i, ii or iii. * able to understand and follow commands, e.g. "stand up, please". * able to sit to stand with or without assistance. exclusion criteria: * any orthopedic procedure in the past 6 months, that could prevent exercise training. * any co-morbid condition such as spinal atrophy, osteogenesis imperfecta etc. * history of chronic seizure attacks. * children with severe visual/hearing impairments. * presence of knee contractures

Keywords: balance cerebral palsy physical function performance mobility spasticity
increasing community-acquired pneumonia protocol adherence by antibiotic stewardship

Conditions: Community-acquired Pneumonia

Summary: the purpose of this study is to determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia.

the purpose of the study is to show a decrease in broad-spectrum antibiotics with a non-inferiority in 90-day mortality. hospitals with a pre-intervention protocol adherence of \>70% are excluded from the primary analysis. primary analysis will be done with a mixed effects model with a random effects for clusters and time. crude outcomes and outcomes adjusted for potential confounders will be reported. primary analysis will be tested one-sided for a decrease in mortality. secondary analysis to test two-sided for mortality will be performed.

Eligibility criteria:
inclusion criteria: * patients diagnosed with cap who get admitted to a non-icu department are eligible for inclusion. exclusion criteria: * patients aged below 18 years * residence in a nursing home or long-term care facility in the last 14 days * patients hospitalized in an acute care hospital for two or more days in the last 14 days * patients with a history of cystic fibrosis * patients with immunodeficiency, defined as having one or more of the following criteria: * hiv infection with a last cd4 count of \<300//μl * cytotoxic chemotherapy or radiotherapy in the previous 3 months * chronic hemodialysis \> 3 months * history of receiving an organ or bone marrow transplant * using immunosuppressive therapy, include corticosteroid treatment only when dosage is high (\>0,5mg/kg/day) for a longer period of time (\>14 days)

Keywords: pneumonia antibiotic stewardship stepped wedge antibiotic
inject: a pilot study of intra-tumoral injections in metastatic urological cancers

Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC); Metastatic Urothelial Carcinoma; Metastatic Renal Cell Carcinoma

Summary: the purpose of this study is to plan for future clinical trials in patients with metastatic urological cancers. diluted iodinated contrast will be injected intra-tumorally under ct fluoroscopy guidance into bone, lymph node, soft tissue and liver metastases in subjects with metastatic prostate cancer, urothelial carcinoma, or renal cell carcinoma. pre- and post-injection ct images will be obtained to determine the injection parameters needed for optimal distribution throughout metastases of a given size. a biopsy of the metastatic site will also be obtained to validate expression of the receptor cd155.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of adenocarcinoma of the prostate, renal cell carcinoma or urothelial carcinoma. small cell or neuroendocrine tumors of the prostate are also permitted. 2. radiographic evidence of at least one bone, lymph node, soft tissue, or liver metastasis, that is amenable to iodinated contrast injection, as judged by the study radiologist 3. adequate laboratory values: 1. platelets ≥ 100,000 2. inr ≤ 1.3 4. age \> 18 years. 5. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. history of intercurrent or past medical or psychiatric illness that would make participation in a research biopsy protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s). 2. cr \>2.0 3. history of iodinated contrast allergy 4. for patients undergoing research only biopsy: requirement for anticoagulation with heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban, warfarin, aggrenox, fondaparux, ticagrelor, etc (aspirin and other nsaids are ok but should be held prior to biopsy in accordance with institutional standard of care) 5. any other contraindication to ct with iodinated contrast, as ct with contrast will be used in the study.
early peanut introduction: translation to clinical practice

Conditions: Peanut Allergy

Summary: the recent finding that early introduction of peanut can prevent \~70-90% of peanut allergy is a major step towards prevention of food allergy. however, because that finding was from a clinical trial in a very select population, there are several major questions that must be answered in order to implement these findings into clinical practice without causing more harm than good. these questions include who, if anyone, should be screened prior to early introduction for peanut allergy, how this screening should be done, and what quantity of peanut ingestion is needed to prevent peanut allergy. the goal of this project is to answer these critical questions so that the potential of these recent findings can be realized. to that end, 400 infants at high-risk of peanut allergy will be enrolled. these infants will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut ige, and then will be followed for assessment of peanut consumption and development of peanut allergy until 3 years of age.

400 infants aged 4-11 months from three high risk groups will be enrolled in a prospective observational study. all subjects will have a baseline research clinic visit, where they will be given a peanut skin prick test, peanut food challenge and have blood drawn for measurement of peanut immunoglobulin e (ige). based on the baseline oral food challenge, the participants will be advised to begin introducing peanut following the current practice guidelines. participants will then be followed until 30 months of age with two clinic visits and regular monitoring of peanut consumption.

Eligibility criteria:
inclusion criteria: * infants age 4-11 months * have at least one of the following criteria: 1. physician diagnosis of milk, egg or other non-peanut food allergy, 2. at least moderate eczema as defined by a scorad score of at least 25 on present or previous evaluation, or a rash that required the application of topical creams or ointments containing corticosteroids or calcineurin inhibitors and occurred on at least 7 days on two separate occasions, or is described by the parent or guardian as "a bad rash in joints or creases" or "a bad itchy, dry, oozing or crusted rash". 3. a first degree relative (parents or siblings) with either a physician diagnosis of ige mediated peanut allergy or reported history of symptoms consistent with ige mediated peanut allergy (onset of symptoms within 2 hours of exposure, and symptoms of urticaria, angioedema, wheezing, vomiting, or abdominal pain with exposure, and no subsequent exposure to peanut without symptoms). exclusion criteria: * history of feeding problems * history of eosinophilic gastro-intestinal disease * significant medical history (aside from eczema, food allergy or history of wheeze) * history of peanut reactions or tolerance prior to baseline screening

Keywords: peanut allergy food allergens atopic dermatitis eczema infant food allergy testing skin prick testing peanut ige early peanut introduction food allergy prevention
comparison of cyanoacrylate tissue adhesive and suture for closure of cardiac device pockets

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.


Eligibility criteria:
inclusion criteria: * scheduled for implantation of a pacemaker or icd in the deltopectoral region at mayo clinic hospital in phoenix. exclusion criteria: * allergy to one of the closure materials.

Keywords: pacemaker cardioverter-defibrillator icd cardiac resynchronization device cyanoacrylate suture dermabond vicryl
heat-not-burn tobacco product to aid in switching from combustible to noncombustible nicotine (iqos)

Conditions: Smoking Behaviors

Summary: a novel heat-not-burn tobacco product (iqos) will be provided to smokers, compared against a (cigarette) smoking as usual period in counter-balanced order in a cross-over design. this study will examine the short-term effects of iqos, switching from combustible to noncombustible nicotine and withdrawal-related symptoms over a two week-long "practice" period, relative to smoking as usual.

the current within-subjects crossover study aims to directly compare initial efficacy of iqos vs (cigarette) smoking as usual on switching from tobacco cigarettes during two-week "practice" periods in smokers. study interventions include iqos, a commercially available, over the counter product. the iqos is a commercially available tobacco product that consists of a holder which contains a rechargeable battery and an electronically heated metal blade. all procedures will take place in the prevention and early detection center (pedc) at the upmc hillman cancer center. participants will be assessed daily via remote co assessment and online questionnaire throughout the entire study (wk1-wk5). at the end of a one-week baseline of normal smoking (wk1), participants will be randomized to either: 1) begin a two-week period of attempting to completely switch to exclusive iqos use (iqos first); or 2) continue to smoke as usual (iqos last; wk2-wk3), followed by a second two-week period during which they will smoke as usual or attempt to switch to iqos (opposite of the first period; wk4-wk5).

Eligibility criteria:
inclusion criteria: * male or female, ages 21-77 * current smoker with ≥5 cigarettes per day for ≥1 year history of smoking * screening co ≥8 ppm * not currently interested in quitting smoking * willing to briefly switch from combustible to noncombustible nicotine * have reliable daily access to a smartphone or tablet compatible with the ico smokerlyzer app: * android 8 or higher, ios 8 or higher * bluetooth-enabled device exclusion criteria: * current use of smoking cessation medications such as varenicline or bupropion * major chronic medical problems, including cardiovascular disease, diabetes * pregnancy (a urine pregnancy test will be administered at screening for all women of child bearing potential).

Keywords: hnb: heat not burn tobacco product iqos: commercially available hnb manufactured