Kornimate/medical-research-clean huggingface dataset:
influence of preprandial metformin administration on carbohydrate absorption

Conditions: Impaired Glucose Tolerance; Type2 Diabetes

Summary: type 2 diabetes is spreading worldwide as well as obesity. metformin is the most prescribed antidiabetic medication. one suggested mechanism of action is by decreasing carbohydrate absorption. it is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. however, if metformin decreases carbohydrate absorption, this might not be the most efficient intake. to study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. we will also evaluate how it impacts gastrointestinal tolerance.


Eligibility criteria:
inclusion criteria: * obesity (bmi ≥30 kg/m2) * dysglycemia (hba1c≥ 6,0 %) * no anti diabetic medication exclusion criteria: * no obesity (bmi \< 30 kg/m2) * no dysglycemia (hba1c \<6,0%) * treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids) * anemia (hb \<12 g/dl) * organ failure * inflammatory bowel disease

Keywords: impaired glucose tolerance type 2 diabetes obesity carbohydrate absorption metformin
echotexture in following muscle fibrosis

Conditions: Congenital Muscular Torticollis

Summary: objective: to document the sternocleidomastoid (scm) muscle fibrosis in congenital muscular torticollis (cmt) infants with quantified echotexture and measured thickness during the treatment course. design: cohort study. setting: rehabilitation department in a tertiary care hospital. participants: infants with clinical diagnosis of cmt, without any neurological presentation, cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the study. intervention: all subjects had physiotherapy for at least 3 months. they underwent at least two times of clinical assessment and ultrasonographic examination (1) for bilateral scm muscles during the follow-up period. end of follow-up: subjects who still had prominent clinical presentations after physiotherapy for 6 months or were older than 1 year would receive surgery. subsided presenting clinical features determined by the clinician was the other end-point of this investigation. main outcome measures: the k value, derived from the difference of echo intensities (2) between the involved and uninvolved scm muscles on longitudinal sonograms, was used to represent the severity of muscle fibrosis in cmt infants. bilateral scm muscle thickness and involved-to-uninvolved thickness ratio (ratio i/u) were also obtained from longitudinal sonograms. clinical outcome was also recorded.

1. an experienced sonographer performed ultrasonographic examination with the subject in the supine position and heads rotated contralaterally to the examination side. a 5-12 mhz linear-array ultrasound transducer was used to observe both longitudinal and transverse views of bilateral scm muscles for each subject. the ultrasound system settings, including gain (86%), monitor dynamic range (70 db), and depth (2 cm), were kept constant throughout the study. 2. the echo intensity was determined by computer-assisted gray scale analysis and was calculated in matlab 2006b. the mean echo intensity of every pixel in the region of interest and the k value developed to compare sonograms between different individuals or between different times in the same subject were estimated as the previous study (pmid: 22215768)

Eligibility criteria:
inclusion criteria: * infants with congenital muscular torticollis presenting clinical features of the cmt infants, including head tilt in the upright position, facial asymmetry, limited passive range of motion in neck rotation, palpable neck mass exclusion criteria: * subjects with neurological symptoms or signs * cervical spine abnormalities * developmental dysplastic hip problems

Keywords: ultrasonography echotexture k value scm muscles cmt infants
cochlear implant with anti-inflammatory agent

Conditions: Hearing Loss

Summary: in an effort to further preserve residual acoustic hearing after cochlear implantation, it may be beneficial to incorporate anti-inflammatory agents into the electrode array for passive elution over a time course after implantation. this study aims to assess the ease and effectiveness of such an electrode design, and to assess the preliminary safety of use of such a device in the post-operative period. this study is a first-time-in-human study of the investigational device. in the first instance, the aim of the current investigation is to obtain first experience in use of a combined device in the adult clinical population, and to assess tools and techniques that may be considered in future clinical studies of similar devices.


Eligibility criteria:
inclusion criteria: 1. duration severe to profound hearing impairment in implanted ear of less than or equal to 30 years 2. post-lingual hearing impairment defined as onset of hearing loss at greater than two years of age 3. evidence of pneumovax vaccination within three years of implantation date (for subjects to be implanted with the investigational device) exclusion criteria: 1. ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or increased risk of infection (i.e. dysplastic cochlea), as confirmed by medical examination and imaging including mri 2. current use of grommets or evidence of tympanic membrane perforation 3. known allergic reaction to dexamethasone or similar medicine 4. diagnosis of auditory neuropathy 5. active middle ear infection or history of middle ear infection within past two years 6. unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device 7. unwillingness or inability of the candidate to comply with all investigational requirements 8. additional disabilities that would prevent or restrict participation in the audiological and medical evaluations required of the clinical investigation

Keywords: cochlear implants dexamethasone combined device
the microbiome of sputum, urine and feces in healthy persons and chronic obstructive pulmonary disease (copd) patients

Conditions: Pulmonary Disease, Chronic Obstructive; Emphysema or COPD; Microbiota

Summary: extensive studies suggest composition of microbiome of respiratory samples or lung tissues in copd patients is different from the composition of healthy smokers. aim of this study is to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to describe difference of composition between copd patients and healthy smokers.

after the introduction of the gut-lung axis theory, extensive studies revealed diversity of microbiomes among healthy smokers and copd patients form the respiratory samples or lung tissues. in the previous study, distinct difference in composition of microbiome in lung tissue between healthy smokers and copd patients was reported. this is a cross sectional study to analyze composition of microbiome of various samples (e.g. feces, sputum, and urine) and to compare difference of composition between copd patients and healthy smokers. this study would help establishing gut-lung axis model in humans.

Eligibility criteria:
inclusion criteria: * patients with smoking history at least 10 pack-year * patients with persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity ( fev1/fvc) \<0.7) exclusion criteria: * patients with co-existing illness that would interfere with study results (e.g., malignancy, congestive heart failure, cerebrovascular disorders, chronic renal failure, diabetes with severe complications, or uncontrolled hypertension) * patients with respiratory disease other than obstructive lung disease (e.g., previous pulmonary resection, tuberculosis-destroyed lung, and bronchiectasis) * patients with recent (8 weeks prior to screening) exacerbation or other respiratory illness

Keywords: emphysema microbiome
redox determinants of severe asthma (a substudy of the severe asthma research program)

Conditions: Asthma

Summary: hypotheses: 1) airway ph regulation is abnormal in severe asthma; 2) in severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways

specific aim 1:test hypothesis that airway ph regulation is abnormal in severe asthma. 1a) determine the effects of systemic corticosteroids on breath ph in children with severe and mild to moderate asthma. 1b) examine whether breath condensate ph and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma. 1c) identify whether increased th1/th2 cytokine ratio, and abnormalities in airway glutaminase, g-sno-reductase, vatpase, and carbonic anhydrase are associated with airway ph disturbance in children with severe asthma. 1d) test whether rhinovirus infections, which reduce airway ph, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma. 1e) examine the relationship between gastroesophageal reflux and proximal airway ph in children with severe asthma and mild to moderate asthma.

Eligibility criteria:
inclusion criteria: * at least 6 years old * asthma diagnosis by physician * current treatment with an inhaled corticosteroid medication exclusion criteria: * bronchiectasis * cystic fibrosis * chronic obstructive pulmonary disease

Keywords: severe asthma poorly controlled asthma
education for prevention and treatment of frailty

Conditions: Frailty; Frail Elderly Syndrome

Summary: frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. the aging of the population in spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy aging, free of fragility and their secondary problems.

to evaluate the efficacy and efficiency of a fragsalud program for the prevention and multifactorial treatment of frailty in people over 65 years of age living in the community compared to the usual treatment. material and methods: a single blind randomized, two-arm clinical trial; control group and intervention group, multicenter, with 15 months of follow-up, with evaluations blinded at the beginning, and in the follow-up at 12 and 15 months. a recruitment of 196 people over 65 years of age with criteria of pre-frailty or frailty according to fried's criteria. the fragsalud education program will be taught in the intervention group; while control group will follow the usual health care. the evolution of the criteria of frailty, cognitive state, eating pattern, emotional state, quality of sleep, perceived social support, quality of life, functional capacity in daily life, adverse results, assessment of self-efficacy and cost-utility analysis variables will be evaluated. possible confounding factors such as sociodemographic variables, comorbidity and polymedication will be controlled. intention-to-treat analysis will be performed.

Eligibility criteria:
inclusion criteria: * patients over 65 years of age who present frailty or pre-frailty, assessed using the fried criteria adapted to spanish population; * patients belonging to clinical management units participating in the study and who will remain in it for the 15 months of the study; * patients who can come to the health center alone or accompanied. exclusion criteria: * patients with no full control of their capabilities. * patients who do not understand spanish; * patients with allergies to plastic or metal. * patients who are instutionalized.

Keywords: elderly persons aging cost-efficiency analysis health education
influence of cardio-ventilatory factors on exercise intolerance in obese adolescents: effects of exercise training

Conditions: Obesity

Summary: worldwide, childhood and adolescent obesity has reached epidemic proportions despite major efforts to promote weight reduction. pediatric obesity commonly presages adult obesity and is associated with the development of weight-related comorbid conditions and increased morbidity. regular physical activity is an important modality of obesity management. despite controversies, poor exercise tolerance has frequently been reported in youth obesity and the cause of this limited exercise tolerance remains unknown. several factors accompanying obesity may interfere with exercise tolerance in obese populations. respiratory factors, such as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary volumes are associated with obesity and may impact exercise intolerance in this population. moreover, even in people with otherwise normal lungs, the normal ventilatory responses to exercise can become constrained in obesity. a thorough understanding of the mechanisms underlying this exercise intolerance remains fundamental in order to favour long term adherence to exercise training. this is especially true in youth populations, in which the management of overweight and obesity must be undertaken as soon as possible, due to the early onset of cardiovascular risk factors. the main purpose of this study is to determine early-onset cardio-respiratory mortality factors in obese adolescents as well as their relation with exercise intolerance (i.e. dyspnea) when compared with age and gender-paired normal-weight volunteers.

physiopathological trial. expected total enrollment : 20 obese adolescents + 20 control subjects tested treatment: exercise training (4 hours per week). treatment duration: 12 weeks

Eligibility criteria:
inclusion criteria: * male and female obese adolescents (bmi \> iotf 30, 12-16 years old) exclusion criteria: * cardiovascular pathology * pathology interfering with physical activity (neurological pathology, severe respiratory illness i.e. asthma, renal failure) * diabetes (known or treated) * participation in another study * asthma (known and treated)

Keywords: obesity adolescent exercise training exercise tolerance
therapeutic antibodies against prion diseases from prnp mutation carriers

Conditions: Prion Diseases

Summary: the human prion diseases can be classified into sporadic, acquired and inherited forms. inherited forms usually manifest in higher age so there have to be factors preventing prion propagation in young mutation carriers. antibodies against the flexible tail of prions have been shown to be protective in mice. the investigators intend to screen mutation carriers and controls for the presence of prion autoantibodies.


Eligibility criteria:
inclusion criteria: * relatives of patients of genetic prion diseases * obtained informed consent exclusion criteria: * no informed consent
acute effects of cinacalcet on arterial stiffness and ventricular function in hemodialysis patients

Conditions: Chronic Kidney Disease

Summary: the primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fpwv. the secondary objectives are to study the effects of calcium reduction on 1) carotid-radial pwv (c-rpwv), 2) common carotid artery (cca) biomechanics, 3) pulse wave profile and cardiac function.


Eligibility criteria:
inclusion criteria: * chronic (\> 3 months) hemodialysis population of \> 18 years old * pth \> 300 ng/l * corrected ca \> 2.10 mmol/l * stable hypertensive drugs (\> 1 month) * stable doses of phosphate binders and dialysis calcium concentration * palpable femoral pulse * systolic bp of 90-180 mmhg * expected survival of \> 6 months exclusion criteria: * hemodialysis \> 3 years * acute infection * history of myocardial infarction or stroke within the past 3 months * inability to consent * intolerance to cinacalcet * inadequate birth control
cd34+ transplants for leukemia and lymphoma

Conditions: Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Acute

Summary: this study will evaluate whether processing blood stem cell transplants using an investigational device (the clinimacs system) results in less complications for patients undergoing transplant for treatment of a blood malignancy (cancer) or blood disorder.


Eligibility criteria:
inclusion criteria: * malignant conditions or other life-threatening disorders correctable by transplant for which cd34+ selected, t-cell depleted allogeneic hematopoietic stem cell transplantation is indicated such as: 1. aml in 1st remission - for patients who is aml does not have 'good risk' cytogenetic features (i.e. t8:21, t 15: 17, inv16). 2. secondary aml in 1st remission 3. aml in 1st relapse or 2nd remission 4. all/cll in patient remission clinical or molecular features indicating a high risk for relapse; or all/cll 2nd remission 5. cml failing to respond to or not tolerating imatinib or dasatinib in first chronic phase of disease; cml in accelerated phase, second chronic phase, or in cr after accelerated phase or blast crisis. 6. non-hodgkin's lymphoma with chemo responsive disease in any of the following categories: 1. intermediate or high-grade lymphomas who have failed to achieve a first cr or have relapsed following a 1st remission who are not candidates for autologous transplants. 2. any nhl in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant. 7. chronic myelomonocyte leukemia: cmml-1 and cmml-2. the following inclusion criteria are also required: * patient's age includes from ≥18 to ≤74 years old. * patients may be of either gender or any ethnic background. * patients must have a karnofsky (adult) performance status of at least 70% * patients must have adequate organ function measured by: cardiac: asymptomatic or if symptomatic then lvef at rest must be 50% and must improve with exercise. hepatic: \< 3x uln ast and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant (e.g. aml chloroma obstructing the biliary tree). patients with higher bilirubin levels due to causes other than active liver disease is also eligible with pl approval e.g. patients with pnh, gilbert's disease or other hemolytic disorders. renal: serum creatinine: s; 1.2 mg/dl or if serum creatinine is outside the normal range, then crcl \> 30 ml/min (measured or calculated/estimated). pulmonary: asymptomatic or if symptomatic, dlco 50% of predicted (corrected for hemoglobin). each patient must be willing to participate as a research subject and must sign an informed consent form. exclusion criteria: * female patients who are pregnant or breast-feeding * active viral, bacterial or fungal infection * patient seropositive for hiv-i /ii; htlv -i /ii * presence of leukemia in the cns

Keywords: stem cell transplant
a study of subcutaneous humira (adalimumab) injection to assess adverse events and change in disease activity in adult participants with moderate to severe active crohn's disease (cd)

Conditions: Crohn's Disease

Summary: crohn's disease (cd) is an incurable chronic inflammatory disorder of the gastrointestinal tract. this study will assess how safe and effective humira (adalimumab) is in treating moderately to severely active cd in china. adverse events and change in disease activity will be assessed. humira (adalimumab) is a drug approved for the treatment of crohn's disease (cd).all study participants will receive humira as prescribed by their study doctor in accordance with approved local label. approximately 252 participants will be enrolled in china. participants will receive subcutaneous humira (adalimumab) injection as prescribed by their physician according to their routine clinical practice and local label. participants will be followed for 1 year. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants meet the diagnosis of moderate to severe crohn's disease. * participants prescribed with humira, under investigators' sufficient consideration of benefits/ risks per local label. exclusion criteria: * participants who have any of the contraindications as per adalimumab (humira) label in china. * participants who are allergic to any component of adalimumab (humira). * participants with active hepatitis b diagnosed. * participants with severe active infection, or known history of active or latent tuberculosis (tb), or latent tb infection with inadequate treatment. * participants with cancer diagnosed, excluding also those with non-melanoma skin cancer (nmsc) completely treated, per local label. * participants with moderate to severe heart failure. * participants who are unwilling to participate, or not suitable for participation as judged by the investigator at risk of noncompliance to study procedure. * participants who are enrolled to other interventional studies. * participants who are prescribed with adalimumab but choose humira bio-similar in china.

Keywords: crohn's disease humira® adalimumab
effect of iron on cerebral dopamine receptor density in non-anaemic premenopausal women with low ferritin and fatigue

Conditions: Fatigue; Iron-deficiency

Summary: this study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on: * changes in the cerebral dopamine (da) receptor density after iron substitution, shown by brain pet * reduction of fatigue and other neuropsychological symptoms after iron supplementation


Eligibility criteria:
inclusion criteria: * healthy female subjects, age \> 18 years, premenopausal, regularly menstruating * bmi 18-25 kg/m2 * serum ferritin level \ 120 g/l * adequate contraception during the study period * fatigue determined as 2 or more points in the basic questionnaire for fatigue * informed consent exclusion criteria: * day-night shift work * 11 or more points in the bdi * no psychiatric disease (as assessed by neuropsychiatric assessment) * 15 or more points in the isi * known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate * intake of iron preparations during the last 8 weeks before the start of the trial protocol * pregnancy or lactation * any cardiovascular or pulmonary disease * acute or chronic infection/inflammation or malignancy * other obvious physical or psychiatric causes for fatigue (known mental disorders, e.g. depression) * chronic intake of concurrent medication (especially antipsychotic drugs), except oral contraceptives. sporadic intake of nsaid or paracetamol, e.g. in the case of a common cold or sporadic headaches is allowed. * crp \> 10 mg/l * tsh out of normal range * any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients. * participation in any other therapeutic trial within the previous month * known history of hiv/hbv/hcv