Kornimate/medical-research-clean huggingface dataset:
effect of the prescription of 10,000 steps per day using a pedometer app in the body composition of overweight adults

Conditions: Overweight; Obesity

Summary: this study aimed the effect of the accupedo pedometer smartphone app intervention, with goal setting of walking prescription of 10,000 steps per day, in overweight adults.

the promotion of the increase in (fa) should be a priority in the treatment of weight loss in overweight or obese subjects. walking is a solution to overcome physical inactivity, due to its low impact in which the person can control the intensity, duration and effort in order to reduce the risk of injury. monitoring the af through the number of steps / day offers the possibility of standardizing the evaluation and monitoring. although the goal of 10,000 steps a day may not be appropriate at various levels of age and physical condition, it is considered a reasonable and motivating goal for healthy adults and previous studies have demonstrated its effectiveness in weight loss programs. the objective of this study is to compare the effect of the implementation of a monitoring system, goal to achieve, on physical activity in overweight and obese adults. both groups, control and intervention, have a prescription of 10,000 steps a day to reach, but only the intervention group will have a control system, messages of encouragement and follow-up. participants (n=120) will be recruited through outpatient from private clinics in cádiz, andalucía, spain, as well as through community presentations. overweight or obese and sedentary adult will be randomly assigned into two groups. for 6 months, all of the adults shall follow the same diet with an identical distribution of macronutrients. there will be a weekly check up of weight, fat, body water and muscle mass for all of them. the status of the number of steps in accupedo is also checked every week

Eligibility criteria:
inclusion criteria: * having a imc \>25, * being sedentary and * have not been submitted to a restrictive diet in the 6 months preceding this study. exclusion criteria: * suffered from type 2 diabetes or renal conditions * being pregnancy or attempt at pregnancy, * being in a maternal lactation period, * being underage * undergoing antidepressant pharmacological treatment

Keywords: obesity physical activity fat mass fat free mass pedometer mhealth
exercise endothelial progenitor cells (epcs) and type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the discovery of the role of endothelial progenitor cells (epcs) and their involvement in the cardiovascular complications of type 2 diabetes (t2dm) would quickly have a significant impact on the millions of americans who have t2dm. this project is designed to 1) determine the mechanisms underlying epc dysfunction in older, sedentary adults with t2dm compared those with normal glucose metabolism and impaired glucose metabolism, and 2) determine if aerobic exercise training is an efficacious therapy for epc dysfunction in t2dm, and whether improvement in epc number and function translates to improved endothelial function, increased capillarization, and improved glucose metabolism in t2dm.


Eligibility criteria:
inclusion criteria: * age 50-80 * non-smoker * if woman, postmenopausal \>1 year exclusion criteria: * history of heart disease or stroke * cancer * poorly controlled hypertension or dyslipidemia * kidney or liver diseases
diagnosis of fatty liver with outpatient ultrasound

Conditions: Liver Steatoses

Summary: this study will evaluate whether ultrasound performed during outpatient visit is effective in early diagnosis of fatty liver.

all patients presenting to dedicated hepatology clinic with concern for fatty liver will be evaluated by ultrasound. this will be compared with standard imaging performed for this condition. the data will be compared for effectiveness of outpatient evaluation with dedicated imaging currently practiced

Eligibility criteria:
inclusion criteria: * all patients presenting to dedicated clinic exclusion criteria: * presence of ascites, inability to give consent to have study
the effect of simple basal insulin titration, metformin plus liraglutide for type 2 diabetes with very elevated hba1c - the simple study

Conditions: Diabetes Mellitus, Type 2; Diabetes

Summary: the aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled type 2 diabetes (a1c \> 10%).

the aim of this study is to compare a glp-1 plus basal insulin and metformin treatment regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled (hba1c\>10%) type 2 diabetes. the investigators will compare the two regimens with respect to efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on patient quality of life, treatment burden, physician time, as well as healthcare related cost. the investigators hypothesize that at 26 weeks from randomization the two treatment regimens will have similar percentage of patients reaching a1c levels \<7.0%, while more patients on the glp-1 plus basal insulin strategy will achieve the composite end point of a1c levels \<7.0% without severe hypoglycemia or significant weight gain.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 2 diabetes with confirmed hba1c level \>10% at time of enrollment, regardless of prior or current treatment regimens, or time since diagnosis. exclusion criteria: 1. age \<18 as the feasibility and safety of this treatment regimen should be first established in the adult population; if successful, a subsequent pediatric study will be proposed; 2. type 1 diabetes as purposefully withholding meal-time insulin is contraindicated; 3. clinical state requiring inpatient admission/treatment; 4. contraindication or strong cautions to any of the study medications: 1. creatinine above 1.4 mg/dl for women and 1.5 mg/dl for men (per metformin label) 2. history of lactic acidosis (per metformin label) 3. advanced hepatic or cardiac disease (per metformin label) 4. age \>80 years (per metformin label) 5. chronic alcohol use (\>14 drinks/week) 6. history of pancreatitis (per liraglutide label) 7. personal or family history of medullary thyroid cancer or men syndrome (per liraglutide label) 8. pregnancy and lactation (per liraglutide label) 5. any serious or unstable medical condition as it would interfere with treatment assignment as well as outcome measurement; 6. any scheduled elective procedures/surgeries; 7. active infections, including osteomyelitis; 8. not willing to participate, unable to keep projected appointments, unwillingness to receive injectable treatment; unwillingness to perform 7-point glucose profiles over 2 consecutive days the weeks prior to randomization (visit 1)and the week prior to visit 6 9. non english speaking.

Keywords: diabetes mellitus, type 2 insulin insulin, long-acting insulin, short acting detemir liraglutide glp-1 glucagon like peptide metformin uncontrolled diabetes elevated a1c incretins
clinical survey of oticon medical ponto implants and a surgical technique with tissue preservation

Conditions: Conductive Hearing Loss; Mixed Hearing Loss; Single Sided Deafness

Summary: a bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness. with this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. an abutment (also in titanium) is attached to the implants and penetrates the skin. the sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. this type of system has been successfully implanted in more than 100.000 patients. recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. the results after using this installation technique, here called soft tissue preservation, are the focus of this study. the objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing oticon medical ponto implants and abutments. the main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.


Eligibility criteria:
inclusion criteria: * 18 years or older * patient indicated for an ear level bone anchored sound processor * bone thickness at the implant site of at least 4 mm exclusion criteria: * inability to participate in follow-up * psychiatric disease in the medical history * mental disability * presumed doubt, for any reason, that the patient will be able to show up on all follow ups * diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus. * patients with natural skin height of \>10 mm

Keywords: bone anchored hearing implant bone anchored hearing device
efficacy, safety, and tolerability of avp-786 for the treatment of agitation in participants with dementia of the alzheimer's type

Conditions: Agitation in Participants With Dementia of the Alzheimer's Type

Summary: participants with agitation secondary to dementia of the alzheimer's type. the diagnosis of probable alzheimer's disease (ad) will be based on the "2011 diagnostic guidelines for alzheimer's disease" issued by the national institute on aging (nia)-alzheimer's association (aa) workgroups.

eligible participants for this study must have a diagnosis of probable ad and must have clinically meaningful agitation secondary to ad. this is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment. approximately 470 participants will be enrolled at approximately 75 centers in north america. study medication will be administered orally twice-daily from day 1 through week 12 (day 85). screening will occur within approximately 4 weeks prior to randomization. following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease (ad) according to the 2011 national institute on aging-alzheimer's association (nia-aa) working groups criteria * the participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization * the diagnosis of agitation must meet the international psychogeriatric association (ipa) provisional definition of agitation * either out participants or residents of an assisted-living facility or a skilled nursing home * clinical global impression of severity of illness (cgis) score assessing agitation is \>=4 (moderately ill) at screening and baseline * mini-mental state examination (mmse) score is between 6 and 26 (inclusive) at screening and baseline * caregiver who is able and willing to comply with all required study procedures. in order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant. exclusion criteria: * participant has dementia predominantly of non-alzheimer's type (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia) * participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) * participant with myasthenia gravis
outcome and safety of recanalization treatments in ischemic stroke due to acute basilar artery occlusion

Conditions: Basilar Artery Occlusion

Summary: rationale: recently, two prospective multicenter rct reported a potential beneficial effect of endovascular thrombectomy (evt) in patients with an acute symptomatic basilar artery occlusion (bao). however, the high rate of crossover in best study and the long-term of recruitment in basics study influenced the validity of the results. objective: to assess the outcomes and prognostic factors of recanalization therapy in patients with bao, caused by a cta/mra/dsa confirmed occlusion of the basilar artery. study design: this is a prospective observational study. study population: patients with acute ischemic stroke and a confirmed basilar artery occlusion by cta/mra/dsa. main study parameters/outcomes: favorable outcome at day 90 defined as a modified rankin score (mrs - functional scale) of 0-3. the estimate will be adjusted for the known prognostic variables age, time from onset to treatment, stroke severity (nihss), pc aspect and collateral flow and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

acute basilar artery thrombosis is associated with a poor prognosis. prevalence of basilar artery occlusion are not known in vietnam.various treatments were tried in groups of patients with acute ischemic stroke due to basilar artery occlusion, but evidence based was not cleared previous studies. therefore, we conduct this study to evaluate the efficacy and safety of recanalization therapies, which included intravenous thrombosis alone, endovascular alone, or bridging ivt and endovascular, in basilar artery occlusion stroke patients.

Eligibility criteria:
inclusion criteria: * symptoms and signs compatible with ischemia in the basilar artery territory. * basilar artery occlusion (bao) confirmed by cta or mra or dsa. * age 18 years or older * patients were treated with one of these among therapies ivt alone, bridging ivt and thrombectomy or thrombectomy alone.. exclusion criteria: * patients did not agree to enroll. imaging exclusion criteria: * high-density lesion consistent with hemorrhage of any degree * significant cerebellar mass effect or acute hydrocephalus

Keywords: basilar artery occlusion recanalisation therapy
evaluation of the treatment with klacid sr in patients with acute tracheitis, tracheobronchitis and bronchitis, acute exacerbation of chronic bronchitis and mild community-acquired pneumonia in common clinical practice in ukraine

Conditions: Respiratory Tract Infections

Summary: to describe the relief of symptoms, tolerability, and compliance of treatment with klacid® sustained release (sr) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired pneumonia. this postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format. klacid sr will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population, and indication as well as with local guidelines.

the postmarketing observational study is observational in nature. its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. follow-up of patients should enable two patient visits during this period. the screening/inclusion visit (visit 1) will be performed when the decision for klacid sr therapy in a daily dose of 1000 mg is made. the second visit of the patient will occur 10 - 16 days from the screening/inclusion visit (upon physician's decision). the physician can change the numbers and time of the visits. as a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Eligibility criteria:
inclusion criteria: * men, women 18 years with 1. acute tracheitis. 2. acute tracheobronchitis. 3. acute bronchitis. 4. mild community-acquired pneumonia. 5. acute exacerbation of chronic bronchitis. * to whom decision to initiate klacid sr therapy in a dose of 1000 mg has been made by physician. exclusion criteria: * known hypersensitivity to macrolide antibiotics * documented renal impairment (creatinine clearance under 30 ml/min) * concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine * pregnancy * breast feeding

Keywords: klacid sr clarithromycin respiratory tract infections bronchitis pneumonia
cmr for prognosis assessment in nstemi

Conditions: Myocardial Infarction

Summary: the prognostic significance of cardiac magnetic resonance (cmr) derived parameters of myocardial and microvascular injury has not been fully elucidated yet in non-st-elevation myocardial infarction (nstemi) patients. in the present study the investigators aim to comprehensively investigate the prognostic significance of cmr in a prospective, multicentre registry cohort of nstemi patients undergoing early percutaneous coronary intervention (pci). cmr will be performed within the first week following the index event. the primary endpoint is defined as a composite of death, reinfarction, and new congestive heart failure (major adverse cardiac events) at 12 months.


Eligibility criteria:
inclusion criteria: patients are eligible for the study if they have: 1) ischemic symptoms in accordance with a possible nstemi diagnosis; 2) elevated cardiac troponin levels above the 99th percentile; and 3) identifiable culprit lesion during early invasive coronary angiography with performed pci. exclusion criteria: 1) stemi; 2) presence of cardiogenic shock; 3) no identifiable culprit lesion or culprit lesion ineligible for pci; 4) indication for acute bypass surgery; 5) age less than 18 years or more than 90 years; 6) pregnancy; and 7) typical contraindications to cmr (e.g. severe claustrophobia, implanted pacemakers and internal cardioverter defibrillators, cerebral or intracranial metallic implants, known allergy to gadolinium and creatinine clearance \<30 ml/min).

Keywords: non-st-elevation myocardial infarction cardiac magnetic resonance prognosis
blood pressure lowering effect of b-vitamins in adults with a genetic pre-disposition to elevated blood pressure.

Conditions: Blood Pressure

Summary: approximately 12% of the world's population have a have a common c677t polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (mthfr). homozygosity for the polymorphism (tt genotype) causes an increased requirement for the b-vitamins folic acid and riboflavin and more importantly results in an increased risk of developing high blood pressure (bp). previous work from our centre has demonstrated significantly higher bp in those with the tt genotype. this work has been conducted in cohorts with premature cardiovascular disease (cvd) and hypertension without overt cvd, but the effect in younger, healthier individuals is unexplored. to date our studies have also focused on bp as the primary outcome, but newer markers of vascular health including central pressure and hemodynamics have emerged as superior prognostic indicators of cvd. the effect of the tt genotype on these measures is an area for investigation and may help us understand the mechanism linking the genotype with bp, which is currently unknown. as adults with the tt genotype have increased requirements for riboflavin and folic acid, and bp in tt adults appears to be riboflavin dependent, the influence of these vitamins on central measures is an area for consideration. study design this is an observational study investigating the blood pressure profiles of healthy adults aged 18-65 years, stratified by mthfr genotype. apparently healthy adults will be recruited from workplaces and the general community across northern ireland and screened for the polymorphism via buccal swab. those with the tt genotype and a similar number of non-tt (i.e. cc/ct) genotype individuals will be contacted and asked to come to a one-off appointment. brachial bp will be assessed by an electronic bp monitor, central bp and central haemodynamics (augmentation index, augmentation pressure and pulse wave velocity) will be assessed by sphygmocor xcel. in addition, anthropometric measurements, health and lifestyle infromation and a blood sample will be obtained. data will be statistically analysed using spss software to if determine differences between gentoype groups exist.


Eligibility criteria:
inclusion criteria: * mthfr 677tt genotype, aged at least 18 years old exclusion criteria: * taking supplements containing b-vitamins * pregnant or planning to conceive * taking medications interfering with folate metabolism * renal or gastrointestinal disease

Keywords: blood pressure central hemodynamics methylenetetrahydrofolate reductase (mthfr) folate polymorphism riboflavin folic acid
visual feedback with optical sensing - a feasibility study

Conditions: Lung Cancer

Summary: lung cancer is the second most common cancer in the united kingdom with around 40,000 new cases diagnosed every year. lung cancer is associated with a very poor prognosis (\<10% patient survival at 5 years). new strategies are urgently needed to improve survival in this group of patients. the most effective and common treatment for lung cancer is radiotherapy (either alone or combined with chemotherapy and/or surgery) and generally high doses of radiotherapy are given to the tumour. however, increasing the radiotherapy dose carries an increased risk of damage to the surrounding healthy tissue. damage can be minimised by reducing movement within the lung, caused by factors such as breathing and patient motion, during treatment. this study tests a new medical device that has been developed to monitor and help patients control their breathing and movement during treatment. optical sensors will detect any motion of the patient's torso and this will be fed back to the patient in the form of a visual aid allowing them to regulate their breathing and maintain their ideal treatment position. the device has already been shown to reduce motion in healthy volunteers. in this study the investigators hope to demonstrate that the visual aids are tolerable in lung cancer patients. the investigators additionally aim to show the device will help reduce movements of the chest and also the lung tumour, leading to improvements in treatment results.

in this study each participant will undergo 4 imaging sessions (one training session and 3 study sessions) where participants will be asked to use the optical feedback display to regulate breathing patterns. the training session and each study session will proceed as follows: * the patient receives standard treatment including any pre-treatment cone beam ct (cbct) imaging. * the patient is allowed to get up off the treatment couch and relax whilst the sensor device is turned on. * the patient is set-up again. * the patient is asked to free-breathe (i.e. breathe normally) and the surface motion is recorded using the optical sensor. the first 30 seconds are used to generate the reference surface used throughout the rest of the process. a 4d cbct scan is acquired during free-breathing to assess tumour motion. * the patient is then asked to control their breathing using the feedback displays and data is recorded for \~1:30 minutes in each case. * a 4d cbct scan will be acquired during controlled breathing with the traffic light feedback visualization scheme to assess tumour motion.

Eligibility criteria:
inclusion criteria: * stage 1-3 lung cancer (non small cell lung cancer and small cell lung cancer; histological diagnosis not mandatory) including at least 5 patients with lower lobe tumours * suitable for radical radiotherapy * tumour judged inoperable by a thoracic surgeon * at least 18 years old exclusion criteria: * stage 4 non small cell lung cancer * unable to give informed consent * epilepsy or migraine