Kornimate/medical-research-clean huggingface dataset:
long-term effects of green tea on gut flora, fat absorption, body composition and resting energy expenditure

Conditions: Obesity

Summary: green tea may have positive effects for weight control and on body composition via several approaches such as a positive effect on the gut flora, a decrease in fat absorption from the intestines and an increase in resting energy expenditure.

green tea may have positive effects for weight control and on body composition via several approaches such as a positive effect on the gut flora, a decrease in fat absorption from the intestines and an increase in resting energy expenditure. we would like to investigate the long-term effects of green tea on gut flora, fat absorption, resting energy expenditure and body composition. the study will be conducted in a randomized, placebo-controlled, double-blind parallel design with four groups consisting of control groups and green tea groups with normal weight subjects and obese subjects. at three time points (baseline, 6 weeks and 12 weeks) faeces are collected for analyzing the gut flora composition and fat content. furthermore, measurements of resting energy expenditure and body composition will be conducted. activity will be measured during three weeks (baseline, week 6 and week 12). a hundred healthy subjects (50 males and 50 females) with a bmi between 18.5-25 kg/m2 and ≥30 kg/m2 and aged between 18-50 years will be included in the study. all subjects will be non-smoking, non tea-drinkers, weight stable, dietary unrestraint, and at most moderate alcohol and caffeine consumers. subjects will be free of medication except for oral contraceptives use in women. intervention (if applicable): subjects will receive either green tea or placebo in capsule form after their baseline measurement, which they have to consume three times daily for a period of twelve weeks.

Eligibility criteria:
inclusion criteria: * bmi between 18.5-25 kg/m2 and ≥30 kg/m2 * age between 18-50 years * healthy * weight stable * dietary unrestraint * not using a more than moderate amount of alcohol (\>10 consumptions/wk) * not using more than 100 mg caffeine per day * not drinking tea * not using probiotics * being weight stable (weight change \< 3kg during the last 6 months) * dietary unrestraint * not using antibiotics during the last 6 months. * free of medication except for oral contraceptives use in women. exclusion criteria: * not healthy * smoking * using a more than moderate amount of alcohol * using more than 100 mg caffeine per day * drinking tea * using probiotics * not being weight stable * dietary restraint * using medication or supplements except for oral contraceptives in women * using antibiotics * not meeting the criteria for bmi and age. * pregnant or lactating women * having allergies for the used food items will also be excluded from participation.

Keywords: obesity body weight gut flora fat absorption
therapeutic optimization in patients in acute geriatric care at university hospital of montpellier

Conditions: Geriatrics; Clinical Pharmacy

Summary: this study involves patients who will be discharged from montpellier university hospital (acute geriatric care unit) between january and march 2020. the primary objective is to assess the number of difference(s) in patient's medicines between the discharge from hospital (acute geriatric care unit) and one month after this discharge. the secondary objectives are: * to assess the number of changes of medicines between the patient's admission and discharge from hospital (acute geriatric care unit); * to evaluate the number of inappropriate medicines in patient's treatment at hospital admission (in acute geriatric care unit) and one month after the discharge from hospital; * to evaluate the number of failures found in the transmission of information between the hospital and the general practitioner/pharmacy one month after the patient's discharge from hospital (acute geriatric care unit).


Eligibility criteria:
inclusion criteria: * patients who will be discharged from hospital (acute geriatric care unit) between january and march 2020 and who will return to their home or to institution for elderly persons * patients for whom there will be at least one change in their medicines between their admission and their discharge from hospital exclusion criteria: * patients who don't want to participate in this study

Keywords: medication reconciliation
the effect of honey on nocturnal cough and sleep quality

Conditions: Cough; Sleep

Summary: cough is a common symptom in pediatric practice. it can be particularly troubling to children and their parents.it often results in discomfort to the child and loss of sleep to both the child and the parent. the objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with uris of a single nocturnal dose of three different honey products compared to placebo

cough is a common symptom in pediatric practice.as a result, children miss daycare or school and parents miss a day of work. in an attempt to threat cough, caregivers frequently administer otc medication to their children,with their attendant risks, kack of proven efficacy and the disapproval of professional organizations such as the aap and the fda. the who has noted honey as a potential treatment for cough and cold symptoms. honey has antioxidant properties and increases cytokine release. the objective of this trial was to compare the effects on nocturnal cough and the sleep difficulty associated with uris of a single nocturnal dose of three different honey products compared to placebo

Eligibility criteria:
inclusion criteria: * 1-5 years of age complying of nocturnal cough that was attributed to a uri. exclusion criteria: * asthma, * pneumonia, * laryngotracheobronchitis, * sinusitis, * allergic rhinitis, * use of cough or cold medication on the night before entering the study.

Keywords: children, cough, honey
correlation between environmental pollution and gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus (gdm) refers to the abnormal glucose metabolism index of pregnant women during pregnancy. at present, about 15% of pregnant women will develop gdm in the second and third trimester, which seriously affects the health of the pregnant woman and the fetus. however, the etiology of gdm remains unclear. various pollutants in the environment may have a potential impact on pregnant women and fetuses. for example, previous studies have shown that exposure to atmospheric pollutants nitric oxide and organochlorine pesticides are associated with gdm. at present, we plan to further investigate the correlation between environmental pollutants and gdm.


Eligibility criteria:
inclusion criteria: * plan to complete ogtt and give birth in the research center * first trimester * singleton pregnancy * without diabetes before pregnancy exclusion criteria: * have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, aids, etc. * fetus has a known deformity or genetic defects * incomplete clinical data * assisted reproductive
evaluation of the aortoseal™ for sealing and fixation of aaa endovascular grafts to aortic wall

Conditions: Abdominal Aortic Aneurysm (AAA)

Summary: the aortoseal endostapling system is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (aaa) with an endovascular graft to provide enhanced fixation and apposition to the aorta.

the device may be implanted at the time of the initial endovascular graft procedure to maintain, or during a secondary procedure to restore, adequate aneurysm. the study includes 5 years of follow-up, with visits at 30 days, 6 months, 1 year, and yearly thereafter through 5-years. follow-up assessments: physical examination, x-ray, ct (with and without contrast) and assessments of any adverse events.

Eligibility criteria:
subjects diagnosed with a qualifying aaa suitable for elective endovascular repair with endovascular graft system or have a previously placed endovascular graft.
a study to investigate the pharmacokinetics and safety of dupilumab in participants ≥2 years to <12 years of age with uncontrolled chronic spontaneous urticaria (csu) (liberty-csu cupidkids)

Conditions: Chronic Spontaneous Urticaria

Summary: this is a multicenter, single-arm, 24-week treatment, phase 3 study. the purpose of this study is to investigate the pk and safety of dupilumab in children diagnosed with csu who remain symptomatic despite the use of h1-antihistamine treatment. study details include: screening: 2 to 4 weeks; the treatment duration will be 24 weeks; follow-up period: 12 weeks; the study duration will be 38 to 40 weeks (including screening and follow-up); the number of study visits will be 6.


Eligibility criteria:
inclusion criteria: * participant must be ≥ 2 years to \<12 years of age, at the time of signing the informed consent. * participants who have history of a diagnosis of csu prior to screening (visit 1) or symptoms consistent with a diagnosis of csu for at least 3 months in the investigator's opinion. * participants with csu (characterized by recurrent itchy wheals with or without angioedema for \>6 weeks) who remain symptomatic at the time of screening despite regular h1-antihistamine treatment. * body weight within ≥5 kg to \<60 kg. * participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * underlying etiology for chronic urticarias other than csu. * presence of skin morbidities other than csu that may interfere with the assessment of the study outcomes. * participants with a diagnosis of chronic inducible cold urticaria. * participants with active ad. * severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study. * participants with active tuberculosis (tb) or non-tuberculous mycobacterial infection, or a history of incompletely treated. * diagnosed with, suspected of, or at high risk of endoparasitic infection. * active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period. * known or suspected immunodeficiency. * active malignancy or history of malignancy within 5 years before the baseline visit. * history of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient. * participation in prior dupilumab clinical study or have been treated with commercially available dupilumab. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the clinical physics research of image guided adaptive radiation therapy for esophagus cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to evaluate the benefit of adaptive radiation therapy (adaptive radiation therapy, art) for esophageal cancer, using dose tracking technique with online images and deformable registration.

the aim of study is to evaluate the benefit of adaptive radiation therapy(art) for esophageal cancer. 80 patients with locally advanced esophageal cancer will be treated with 3d-crt(three dimensional conformal radiotherapy, 3d-crt)/imrt(intensity modulated radiotherapy, imrt), dividing to experimental group and control group (40 patients each). all patients are kvct(kilo-voltage computed tomography, kvct) scanned weekly(the fifth fraction in a week) and cbct (cone beam computed tomography, cbct) scanned per fraction before treatment. irradiated dose distribution of each patient is calculated using the cbct images corrected with validated modelling and accumulate the volumetric dose for all ptv(planning target volume,ptv) and oars(organs at risk, oar) using deformable registration algorithm. for the experimental group, replan the treatment when the target volume is not covered by the prescribed dose or oars is overdose beyond the action level to achieve an optimal dose distribution. conversely, no action is taken in the control group and the original plan will be used for the full treatment course. dosimetric parameters (such as the ratio of target coverage, the mean dose of oars, etc) ,treatment toxicities (such as radiation pneumonitis and esophagitis), pfs（progress free survival,pfs）and os（overall survival, os）of the two groups will be analyzed and compared in the study.

Eligibility criteria:
inclusion criteria: * diagnosed with locally advanced esophageal cancer * ecog(eastern cooperative oncology group, ecog) physical status score：0-2 * charlson complications index score≤4 * first second forced expiratory volume ≥1 liter * patients and their families agreed and signed the informed consent exclusion criteria: * previous treatment with other malignant tumor * had anti-tumor treatment, including (chemotherapy, radiotherapy, surgery) * any taboo disease or condition of radiotherapy and chemotherapy * with malignant pleural effusion and pericardial effusion * participated to other clinical test within 30 days before this experiment * with uncontrolled seizures or loss of mental self-control * drug takers, chronic alcoholism, and hiv/aids patients * has a history of severe allergic or specific physique * researchers think that is unfavorable to the test

Keywords: esophageal cancer adaptive radiation therapy
the effects of white noise on agitated behaviors and cortisol level in saliva among the patients with dementia

Conditions: Dementia

Summary: the purpose of this study will be to examine the effects of white noise on agitation and saliva cortisol in elderly with dementia.

aging society is a global trend. in general, each additional five years for older than 65 years old, doubling the prevalence of dementia, that means is constantly increasing in dementia patients. dementia elderly often appear negative emotion, memory disorders, sleep disorder and agitated behavior. with the progression of dementia, many patients present "sundown syndrome", which particularly appear agitation, hallucinations, delusions in the evening or at night and even accompanied by delirium and confusion. when the patient increased nocturnal awakenings, and even lead to roam at night and confusion, resulting in stress for families and carers. therefore, the purpose of this study will to examine the effects of white noise on agitation and saliva cortisol in elderly with dementia. the sample sizes was calculated (power: 0.8, α level: 0.05, effect size: 0.5) by g-power statistical software. the estimated number of samples will be 35 cases for each group and the loss following rate of 20% will be considered and then each group will recruite 42 cases. in total, 84 cases will be recruited to participate the study. four dementia care centers located in central and southern taiwan will be selected and were randomly assigned to the experimental group (two centers) and the control group (two centers). the experimental group will receive 20 minute white noise of the ocean and the sound of running water at 16:00 to 17:00 for four weeks periods. the control group will receive usual care. before the intervention and pretest, participants will be collected three days of saliva cortisol and observed agitation behavior for 10 days. after the four weeks of white noise intervention, post-test questionnaire, agitation behavior and saliva cortisol will be collected. the information collected will be entered into the computer spss 20.0 software for statistical analysis. white noise is a simple, convenient, non-invasive and effective intervention that hopes to improve the agitation behavior and saliva cortisol levels and improve quality of care for dementia elderly.

Eligibility criteria:
inclusion criteria: * 65 years and older * no hearing disorders * able to communicate in mandarin or taiwanese * able to attend the program and fill out inform consent. exclusion criteria: -

Keywords: dementia white noise agitation saliva cortisol
efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (pfs) in participants with previously treated chronic lymphocytic leukemia (cll).


Eligibility criteria:
key inclusion criteria: * adults with previously treated recurrent cll who have measurable lymphadenopathy * require therapy for cll * have experienced cll progression \< 24 months since the completion of the last prior therapy * have disease that is not refractory to ofatumumab note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: cll chronic lymphocytic leukemia gs-1101 cal-101 ofatumumab
efficacy and safety study of udenafil in patient with pulmonary arterial hypertension(pah)

Conditions: Pulmonary Arterial Hypertension

Summary: this is a placebo-controlled, double-blind, phase ii clinical study to evaluate the efficacy and safety of udenafil in patient with pulmonary arterial hypertension(pah).


Eligibility criteria:
inclusion criteria: • subjects aged 18 and over who have any of the following diseases * primary pulmonary arterial hypertension * secondary pulmonary arterial hypertension caused by connective tissue disease * \[phase iib\] pulmonary arterial hypertension caused by congenital heart disease(including eisenmenger syndrome) exclusion criteria: * subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria * bmi(body mass index) \< 18.5kg/m2 * subjects with hypotension(sbp/dbp\ 170/100mmhg) * creatinine clearance ≤ 30ml/min * history of non-arteritic anterior ischemic optic neuropathy(naion)
safety study of anti-ige immunotherapy in allergic patients

Conditions: Allergy

Summary: the purpose of the study is to evaluate safety and efficacy of three doses and two dosing regimens of rp01 as an anti-ige immunotherapy in allergic patients.

immunotherapy is based on the principle of eliciting an immune reaction in order to block the negative effect of a specific disease-causing protein. the potential to treat diseases by means of immunotherapy instead of using conventional drugs represents an attractive opportunity in a number of chronic disease areas, including asthma and allergy. resistentia's model to treat allergic diseases, and ultimately asthma, is to use the immune system to produce antibodies against the ige molecules themselves. the resulting anti-ige antibodies intercept and form complexes with the ige molecules before they can bind to the mast cells and basophils and are thus able to block any allergen-triggered inflammatory reaction. the approach works in all types of ige-mediated allergies independently of allergen, and also in patients sensitive to multiple allergens. comparisons: three doses and two dosing regimes of rp01 will be compared as regards safety and effect.

Eligibility criteria:
inclusion criteria: * allergy to at least one aero allergen * increased serum ige level exclusion criteria: * diagnosis of asthma * recent use of systemic corticosteroids or immunosuppressive treatment * allergy vaccination therapy

Keywords: immunotherapy allergy
utility of psychosocial intervention in improving outcome for methadone-exposed infants and their mothers

Conditions: Neonatal Abstinence Syndrome

Summary: opiate drug abuse/addiction is a significant co-morbidity in pregnancy. opiate maintenance program enhances the outcome of pregnancies for the mother and the infant. our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.


Eligibility criteria:
inclusion criteria: * positive methadone tox screen * received care at good samaritan hospital in cincinnati * delivered at good samaritan hospital exclusion criteria: * twin gestation * sever congenital anomalies * conditions requiring transfer to quaternary hospital
association between cortisol, cortisone, cotinine, nicotine, caffeine, melatonin levels in hair, serum, urine, saliva and chronic stress

Conditions: Hydrocortisone

Summary: the investigators aim to investigate the association between hair, serum, urine and saliva to measure cortisol, cortisone, cotinine, nicotine, melatonin and caffeine.


Eligibility criteria:
inclusion criteria: * adult volunteer exclusion criteria: * students of the study host * people who have steroid or melatonin medicine

Keywords: biomarker
study to determine effects of vesicare on return to continence post - radical prostatectomy (part ii)

Conditions: Urinary Incontinence

Summary: prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men. radical prostatectomy is one of the treatment options available for organ-confined disease. over 100,000 radical prostatectomies cases (total removal of the cancerous prostate by surgery) are performed in the united states yearly. unfortunately nearly all of the men undergoing surgery report diminished quality of life (qol) scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day. many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency, and have overall decreased urinary satisfaction scores. abatement of these symptoms can take up to one year in men, and in 5-20% of patients symptoms may persist for longer periods. our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence. this 'detrusor muscle' instability results in excess contractions of the urinary bladder ('urgency to urinate'), and can result in the feeling of needing to urinate more frequently. consistent with this hypothesis of detrusor muscle instability, men with postoperative dribbling had more complaints with urgency, frequency and bother scores when queried with validated questionnaires. we suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patient's dribbling of urine. by treating the bladder muscle instability, we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate. this pilot study will assess the statistical requirements for the number of subjects needed for a fully 'powered' randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients' quality of urinary life and improve postoperative urinary incontinence after surgery. \*this study has been modified from the original protocol with the clinicaltrials.gov id: nct00581061.


Eligibility criteria:
inclusion criteria: * patients that have been diagnosed with prostate cancer and will undergo treatment for the disease as part of standard clinical care * patients that have multiple pad use a few days after standard of care catheter removal exclusion criteria: * contra-indication to solifenacin * narrow angle glaucoma * hepatic impairment * renal impairment * cyp3a4 inhibitors (e.g. ketoconazole) * gastric retention (delayed or slow emptying of the stomach) * lives in a different country

Keywords: incontinence robotic prostatectomy prostate cancer