Kornimate/medical-research-clean huggingface dataset:
promoting the self-regulation of energy intake

Conditions: Obesity

Summary: the goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.

the intervention program was developed and piloted. expected outcomes: at the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered (e.g., repeated presentation of new foods, involvement in food preparation) and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style (feeding responsiveness); 3) show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge (e.g., best feeding practices, reduced feeding misconceptions). children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. at the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). all effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. although we do not expect effects on bmi after 6 weeks, we expect to see decreases in children's bmi percentiles by the 6- and 12-month follow-ups for the intervention group-especially for the top 25% of the bmi percentile range. no parental bmi effects are expected.

Eligibility criteria:
inclusion criteria: * parents whose children attend head start with the sample of children equally split on gender and ethnicity, * with representation from ages 3 to 6 years. exclusion criteria: * parents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.
fracture risk evaluation of bone metastases derived from carcinoma

Conditions: Bone Metastases

Summary: from the archives of the rizzoli institute all patients (approximately 750) treated for bone metastases from 01/01/2010 to 31/12/2022. a review will be made from the medical records, radiological imaging, and histological data of these patients


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of bone metastasis from carcinoma, regardless of the type of carcinoma, and of the number and location of the metastases * availability of imaging and clinical data * availability of at least one follow-up during the last 12 months form diagnosis exclusion criteria: * at least one inclusion creteria not met

Keywords: bone metastases prediction model
closed-loop brain stimulation as a potential intervention for cognitive decline

Conditions: Mild Cognitive Impairment

Summary: the goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in cognitively healthy adults and older adults diagnosed with mild cognitive disorder (mci). the main questions it aims to answer are: * whether it is possible to restore various cognitive functions in older adults diagnosed with mci by delivering theta burst stimulation (tbs), a form of transcranial magnetic stimulation, and * whether closed-loop tbs is able to induce therapeutic benefits that outperform open-loop tbs. participants play a cognitive video game while a brain-computer interface (bci) analyzes their electroencephalogram (eeg) signals and decodes the presence or absence of the contingent negative variation (cnv) potential, a marker of cognitive control. the bci triggers tbs when its outputs indicate that the participant is not engaged properly in the video game. researchers will compare the effects of sham, closed-loop, and open-loop tbs using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.


Eligibility criteria:
inclusion criteria: * cognitively normal younger adults 1. ages between 18 to 35 years 2. good general health 3. normal or corrected vision 4. completed elementary school education or able to understand middle school level experiment instructions * cognitively normal older adults 1. ages between 60 to 90 years 2. good general health 3. normal or corrected vision 4. completed elementary school education or able to understand middle school level experiment instructions 5. score of 23 or higher on the montreal cognitive assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment * older adults with mild cognitive impairment (mci) 1. ages between 60 to 90 years 2. diagnosis of mci according to the national institute on aging - alzheimer's association (nia-aa) criteria 3. good general health 4. normal or corrected vision 5. completed elementary school education or able to understand middle school level experiment instructions exclusion criteria: 1. neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.). 2. current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.) 3. current use of cognitive enhancing medications (e.g., adderall, memantine, etc.) 4. factors hindering eeg acquisition and tms delivery (e.g., skin infection, wounds, dermatitis, etc.) 5. factors hindering mri acquisition (e.g., implants, metallic tattoos, etc.)

Keywords: mci older adults cognitive control memory impairment
ceftazidime-avibactam for the treatment of infections due to ceftazidime resistant pathogens

Conditions: Complicated Urinary Tract Infection; Complicated Intra-abdominal Infection

Summary: to evaluate the effects of ceftazidime-avibactam and best available therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.

an open-label, randomized, multicenter, phase iii study of ceftazidime avibactam (caz-avi, formerly caz104) and best available therapy for the treatment of infections due to ceftazidime resistant gram negative pathogens

Eligibility criteria:
inclusion criteria: * patient must be ≥18 and ≤90 years of age * female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving iv study therapy and for a period of 7 days after * patient has a ceftazidime-resistant gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection exclusion criteria: * patient has an apache ii score \>30 (ciai patients only) * patient has an infection due to gram negative pathogen that is unlikely to respond to caz-avi treatment (eg, acinetobacter spp., stenotrophomonas spp.) * patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant patient is immunocompromised * patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.

Keywords: ceftazidime, avibactam, metronidazone, anti-infectives
safety and pharmacokinetics of alpha-1 proteinase inhibitor in subjects with alpha1-antitrypsin deficiency

Conditions: Emphysema; Alpha 1-antitrypsin Deficiency (AATD)

Summary: this is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of prolastin-c (alpha1-proteinase inhibitor \[alpha1-pi\] \[human\]), compared to weekly infusions of 60 mg/kg of prolastin-c in patients with alpha 1-antitrypsin deficiency (aatd).

the question of whether higher doses of alpha1-pi (\>60 mg/kg) are able to provide better protection to patients with alpha 1-antitrypsin deficiency is currently unknown. as a first step to address this question, the present study has been undertaken. this is a multi-center, randomized, double-blind, crossover study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of prolastin-c, compared to weekly infusions of 60 mg/kg of prolastin-c in patients with alpha 1-antitrypsin deficiency. this study is a crossover design with 2 treatment sequences: treatment sequence 1: 60 mg/kg weekly infusion of prolastin-c for 8 weeks followed by 120 mg/kg weekly infusion of prolastin-c for 8 weeks (starting at week 1) (total of 16 treatment weeks) treatment sequence 2: 120 mg/kg weekly infusion of prolastin-c for 8 weeks followed by 60 mg/kg weekly infusion of prolastin-c for 8 weeks (starting at week 11) (total of 16 treatment weeks) approximately 15 subjects are planned to be entered into each treatment sequence. at weeks 8 to 11 and weeks 18 to 21, a total of 15 serial blood samples for each subject will be drawn for pharmacokinetic analysis. the expected duration of the study subject's participation will be approximately 25 weeks (which includes a 3-week screening phase, 2-week washout period \[between different alpha-1 pi treatment doses\], and a 4-week follow-up period). the following safety parameters will be assessed: adverse events, pulmonary exacerbations, vital signs, pulmonary function tests, and clinical laboratory tests.

Eligibility criteria:
inclusion criteria: * be between 18 and 70 years of age * have a documented diagnosis of congenital aatd * have a post-bronchodilator forced expired volume in 1 second (fev1) of ≥30% and \<80% and fev1/forced vital capacity (fvc) \<70% * if receiving alpha-1 pi augmentation therapy, be willing to discontinue the treatment for the duration of the study exclusion criteria: * had a moderate or severe pulmonary exacerbation during the 4 weeks before the study * history of lung or liver transplant * any lung surgery during the past 2 years * confirmed liver cirrhosis * elevated liver enzymes * severe concurrent disease * females who are pregnant or breast-feeding or unwilling to practice effective contraception during the study * infection with hepatitis a, b, or c, human immunodeficiency or parvovirus b19 * smoking during the past 6 months * use of systemic steroids within 4 weeks of the study * use of antibiotics for an exacerbation within 4 weeks of the study

Keywords: emphysema alpha 1-antitrypsin alpha 1-antitrypsin deficiency (aatd) alpha 1-proteinase inhibitor (alpha-1 pi)
lavender aromatherapy on sleep quality and metabolic parameters of type 2 diabetic patients with insomnia

Conditions: Diabetes Mellitus, Type 2; Sleep Disturbance

Summary: this study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.the primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

considering the high prevalence of sleep disturbance in diabetic patients and the effectiveness of lavender in treatment of sleep disorders in this study the efficacy of lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be investigated. this study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.the primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 * age between 25-65 years old * fasting blood sugar between 70-130 * 2 hour post prandial glucose less than 180. * hba1c less than 7 * sleep disorder according to pittsburgh insomnia rating scale more than 5. exclusion criteria: * any systemic illnesses * use of sedative or antidepressant drugs * pregnancy * lactation * history of allergic reaction to lavender * history of allergic rhinitis, asthma and respiratory disorders * anosmia * headache that start with smell * cigarette smocking or substance abuse * hospitalization or surgery within 1 months ago. * work shift
glidescope spectrum video laryngoscope blades and stylet for use in neonate & pre-adolescent populations

Conditions: Pediatric ALL

Summary: the overall purpose of this study is to assess the functionality \& impact of the use of the newly designed glidescope spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models.

the overall purpose of this study is to assess the functionality \& impact of the use of the newly designed glidescope spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. the hypothesis is that the spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin. secondary aims of this study include assessing the impact of spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical \& functional usefulness in airways with predictors of difficult intubation.

Eligibility criteria:
inclusion criteria: * anesthesia and emergency medicine providers who perform pediatric orotracheal intubations * able to give voluntary consent to participate in the study * are experienced with orotracheal intubation (\> 50 times) using direct laryngoscopy or video laryngoscopy exclusion criteria: * volunteers who are \< 18 years of age * volunteers unable to read or understand english * unable to physically meet the demands of orotracheal intubation or those who have heart, wrist, or low back disease. are not experienced with pediatric orotracheal intubations
hemodynamic and salivary responses of 12 weeks of training with different anti-hypertensive

Conditions: Hypertension; Menopause

Summary: different classes of antihypertensives may have different responses when associated with exercise. thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women.

cardiovascular diseases are the leading causes of death and postmenopausal women. physical exercise, in turn, is a strategy to reduce cardiovascular stress, by decreasing the blood pressure (bp) at rest and several risk factors associated with sedentary lifestyle, thus improving the quality and life expectancy of these women. however, different classes of antihypertensives may have different responses when associated with exercise. thus, this study aims to compare the responses of the association of 12 weeks of aerobic exercise and weightlifting with different classes of medications in 45 postmenopausal hypertensive women. the volunteers will do cardiovascular and biochemistry evaluations before and after the intervention.

Eligibility criteria:
inclusion criteria: * women aged between 50 and 70 years; * be in the postmenopausal phase; * be able to practice physical exercise on treadmill and bodybuilding, * receive a release certificate for exercise practice; * do not present physical problems or cardiovascular complications that prevent the performance of physical exercises; * in the case of hypertensives: present stage 1 hypertension, according to the guidelines of the brazilian society of hypertension (2010); * in the case of hypertensive patients, undergo drug treatment with β-blockers or angiotensin receptor blockers. exclusion criteria: * present history of stroke or acute myocardial infarction; * smokers; * present diagnosis of diabetes mellitus or renal pathologies; * use of antihypertensive drugs from classes that were not selected for this project; * make use of hormonal therapies; * being uncompensated hypertensive.

Keywords: combined exercise ambulatorial blood pressure monitoring blood analysis salivary analysis heart rate variability
a single dose study to evaluate the pk-pd response and safety of pha-794428 in children with growth hormone deficiency

Conditions: Growth Hormone Deficiency

Summary: this will be the first clinical study of the development of pha-794428 in a pediatric population. since differences in pk and/or pd response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. in addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using pk/pd modeling

the study terminated on 10-dec-2007. pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical phase 2 studies after a single injection of pha 794428.

Eligibility criteria:
inclusion criteria: * 1.male and female children with a minimum age of 6 years * 2. prepubertal as defined by tanner staging * 3. growth hormone deficiency exclusion criteria: * 1. pghd patients with uncontrolled pituitary tumor growth * 2. tumors within 3 mm of the optic chiasm * 3. serum alt and/or ast \>= 1.5 times the upper limit of normal range
heart failure biomarkers

Conditions: Atrial Fibrillation (AF); Hart Failure

Summary: systemic inflammation is closely associated with the development and progression of heart failure (hf). the study assessed the fibrin/albumin (far) ratio, a very important biomarker, as a prognostic indicator of he. study population is composed by patients who were addicted with heart failure diagnosed for the first time or already under treatment (nyha class ii-iv) and reduced ejection fraction (hfref) or preserved ejection fraction (hfpef).

prospective, observational, single-center study, which involves the enrollment of patients affected by heart failure of first diagnosis or already in therapy, who will be subjected to an analysis of the albumin/fibrinogen ratio. subjects will not be subjected to specific visits or services for the study: clinical and anamnestic data will be collected during routine visits.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years * patients with newly diagnosed or already treated heart failure (nyha class ii-iv) with hfref and hfpef with and without atrial fibrillation. * patients who sign the consent to participate in the study exclusion criteria: * patients with infectious/autoimmune diseases, neoplasms, liver failure, renal failure (cl creatinine \&lt; 30 ml/l), structural cardiomyopathies and pericarditis. * pregnant/breastfeeding women (verified by self-declaration)

Keywords: hart failure ejection fraction atrial fibrillation
metabolic response of slow released carbohydrates in diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the study was conducted 1. to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia 2. to describe the kinetics of glucose absorption after a load of isomaltulose 3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients.

epidemiological studies have shown that postprandial hyperglycemia is associated with atherosclerotic diseases. therefore, therapeutic strategies to reduce postprandial hyperglycemia are desirable. an effective way to improve postprandial glucose level is the use of carbohydrates with low glycemic index. isomaltulose is a reducing disaccharide occurring naturally in honey and sugar cane juice, including products derived thereof. it is an isomer of sucrose and composed of glucose and fructose linked alpha-1,6 instead of alpha-1,2. isomaltulose has been reported to be digested more slowly than sucrose. due to this property, lower and slower increases in blood glucose responses are expected for isomaltulose than sucrose. early studies have demonstrated attenuated glycemic and insulin responses after isomaltulose ingestion than after sucrose. this study was performed to describe the postprandial glucose metabolism more comprehensively after bolus administration of different doses of isomaltulose compared to sucrose in type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * diagnosis: type 2 diabetes according to who/ada criteria for more than 1 yr * adults aged 18-75 years old * hba1c \< 8%, fasting blood glucose \< 140 mg/dl * for at least 2 months prior to visit 1, subjects must have been on a stable antidiabetic therapy regimen * subjects willing to perform home blood glucose monitoring and to otherwise comply with study protocol requirements exclusion criteria: * type 1 diabetes mellitus * pregnant or lactating women or women planning to become pregnant * women who become pregnant will be withdrawn from the study * clinically significant heart, liver, lung, or kidney disease * drug or alcohol abuse * concomitant therapy with systemic glucocorticoids or acarbose * subjects unable to adhere to instructions during the qualification phase

Keywords: isomaltulose slow released carbohydrates postprandial glucose metabolism type 2 diabetes
positron emission tomograph(pet) imaging explores the role of sf-devd-2 in monitoring tumor efficacy

Conditions: Breast Cancer Stage II; Breast Cancer Stage III; Solid Tumor

Summary: this is a single arm study to determining the value of apoptotic molecular probe sf-devd-2 in the early evaluation of tumor efficacy and comparing it head-to-head wihe 18f-fdg(18f-2-fluoro-2-deoxy-d-glucose)


Eligibility criteria:
inclusion criteria: 1. patients voluntarily signed informed consent; 2. age18-70, male or female; 3. diagnosed with stage 2 or 3 breast cancer 4. solid tumors、masses larger than 2cm with lymph node metastasis 5. pathology is her3+、triple negative patients 6. patients to be treated with neoadjuvant chemotherapy exclusion criteria: 1. age greater than or equal to 70 years old 2. abnormal liver and kidney function (more than five times the normal value) 3. diagnosis level of breast cancer stage 4 or second time tumor patients