Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of mediguide system in cardiac resynchronization therapy (crt) implants

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the safety and performance of the mediguide™ system during crt implants.


Eligibility criteria:
inclusion criteria: * meet clinical indication for implantation of an sjm crt system according to the current european society of cardiology (esc) guidelines for cardiac and resynchronization therapy * receiving a new implant or undergoing an upgrade from an existing icd or pacemaker implant with no prior lv lead placement * ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations exclusion criteria: * currently participating in any other clinical study * have prosthetic valves * are pregnant or planning pregnancy in the next 1 month * are less than 18 years of age * have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction
study on tolerability of levodopa/carbidopa in children with angelman syndrome

Conditions: Angelman Syndrome

Summary: this study is designed to determine the highest dose of levodopa/carbidopa that can be tolerated without any serious side effects by children with angelman syndrome. it has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with angelman syndrome. data from this study will be used to design a phase ii trial to determine the efficacy of levodopa in treating children with angelman syndrome.

levodopa is a prodrug that "delivers" dopamine to the brain. it is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa. animal studies have suggested that levodopa can reverse the excess phosphorylation of some enzymes involved in synaptic and neuronal function, including calcium/calmodulin-dependent kinase type 2 (camkii). recently, it was shown that excess phosphorylation of camkii may be responsible for some of the neurological deficits seen in angelman syndrome. therefore, it is hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with angelman syndrome. although many children have used levodopa for a variety of medical conditions over the last 30 years, it has not been approved by the food and drug administration (fda) for use in children, and it has not been formally studied in children with angelman syndrome, so we do not know what dose of levodopa is most appropriate for children with angelman syndrome. therefore, the purpose of this study is to find out the highest dose of levodopa that children with angelman syndrome can tolerate without any serious side effects. once we know the dose of levodopa that can be tolerated by children with angelman syndrome, we will conduct a larger follow-up study to find out whether levodopa will lead to an improvement in their development and tremor.

Eligibility criteria:
inclusion criteria: * angelman syndrome, confirmed by molecular testing * must be willing to come for research visit on 2 days, exactly 1 week apart exclusion criteria: * on levodopa, carbidopa, or any dopamine agonists in the 2 weeks prior to participation * other medical conditions that may be associated with developmental or cognitive delays * more than 2 clinical seizures per month * used monoamine oxidase (mao) inhibitors within the last 2 weeks * used phenytoin within the last 2 weeks * used phenothiazines, butyrophenones, and thioxanthenes within last 2 weeks * hypersensitive to levodopa or carbidopa * cardiovascular disease or instability * respiratory diseases, including asthma, emphysema, chronic cough, and shortness of breath * liver disease * stomach or intestinal ulcers * kidney disease * hematological problems, including anemia, leucopenia, and thrombocytopenia * used investigational drugs/interventions within the past three months

Keywords: angelman syndrome levodopa carbidopa l-dopa
treatment of painful digital neuroma using a pedicled nerve flap

Conditions: Painful Digital Neuroma

Summary: neuroma excision and digital nerve reconstruction remain the best option for the treatment of painful digital neuroma (pdn). when the distal nerve end is preserved, conventional nonvascularized nerve grafting is the primary option to bridge the defect. the investigators hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital nerve is better than conventional methods for reconstruction of the digital nerve defect after painful neuroma resection. this study reports treatment of painful digital neuroma using a pedicled nerve flap taken from the dorsal branch of homolateral digital nerve. from may 2007 to march 2010, the patients had previous nerve injuries with or without nerve repair. the mechanisms of injury include sharp cut, avulsion and crush. the defects were between the middle of the distal phalanx and the palmar digital crease.

our selection criteria in this study included a patient with pdn in a scarred wound bed or poor coverage, a pdn located between the middle of the distal phalanx and the palmar digital crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length. the exclusion criteria included a pdn in healthy soft tissue, a digital nerve defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb neuroma. a finger with a small distal end of the digital nerve was also excluded, because neurorrhaphy was extremely difficult in this situation.

Eligibility criteria:
inclusion criteria: * a patient with pdn in a scarred wound bed or poor coverage * a pdn located between the middle of the distal phalanx and the palmar digital crease * a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length exclusion criteria: * a pdn in healthy soft tissue * a digital nerve defect longer than 3 cm * injury to the course of the pedicle or the donor nerve * a thumb neuroma

Keywords: painful digital neuroma nerve defect dorsal branch of the digital nerve digital nerve pedicled nerve flap pain disorder associated with psychological and physical factors
safety and efficacy study of jtt-130 in obese type 2 diabetic patients

Conditions: Type II Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effect of jtt-130 on diabetes as well as the safety and tolerability of jtt-130 in obese type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: 1. have type 2 diabetes; 2. body mass index (bmi) of \> 27.0 kg/m2 and ≤ 45.0 kg/m2; 3. are either drug naïve with respect to hypoglycemic agents or are currently being treated with metformin alone or in combination with a sulfonylurea. metformin and sulfonylurea dosing must be stable. exclusion criteria: 1. females who are pregnant or breast-feeding 2. known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy; 3. acute coronary syndrome or uncontrolled hypertension; 4. does not meet medication restriction criteria, as described in the protocol.

Keywords: diabetes
effect of bety on biopsychosocial states associated with chronic pain in rheumatic individuals.

Conditions: Rheumatic Diseases

Summary: no study has been found in the literature investigating the effectiveness of an innovative exercise approach defined on a biopsychosocial basis and having its own original scale on individuals with rheumatism over the years. the aim of this retrospective study was to determine the effects of the cognitive exercise therapy approach on the biopsychosocial conditions related to chronic pain; functionality, mood and quality of life of individuals with rheumatism diagnosis and to examine the effectiveness of bety as a routine exercise approach by presenting the results compared with the control group.

cognitive exercise therapy approach (bety) is an innovative exercise approach developed through the participation of rheumatic individuals in exercise sessions for many years. the main purpose of bety is to transfer the patient's negative cognitions about their disease to a positive cognition level through functional gains through exercise. thus, cognitive restructuring will be achieved. in order to correctly organize the optimum treatment, rheumatic patients need to be evaluated biopsychosocially. individual-centered scales that evaluate the disease process are currently considered at least as much as objective tests in determining treatment effectiveness and are increasingly used in clinical practice. due to the multidimensional structure of chronic diseases, there is a need for measurement tools that evaluate individuals in a biopsychosocial context. bety-biopsychosocial scale (bety-bq) was developed for this purpose with the feedback of the recovery characteristics of rheumatic individuals who participated in bety sessions over the years.

Eligibility criteria:
inclusion criteria: - patients who were diagnosed as ankylosing spondylitis (1984 modified new york criteria, ra (2010 acr/eular criteria), psa (2006 caspar criteria), sle (2012 systemic lupus international collaborating clinics criteria), ssc (2013 acr/eular criteria), pss (american-european consensus group criteria), oa (1986 acr criteria) and fms (2016 acr criteria) exclusion criteria: * patients who had severe cognitive problems

Keywords: biopsychosocial holistic exercise functioning sleep chronic pain
a study of the safety and levodopa pharmacokinetics following single dose administration of cvt 301 (levodopa inhalation powder) in smoking and non-smoking adults

Conditions: Smoking

Summary: this is an open label, parallel group study to evaluate the pharmacokinetics (pk) and safety of a single dose of cvt-301 in smoking and non-smoking adults.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) 18 to 32 kg/m2; * forced expiratory volume in one second (fev1) ≥80% of predicted for race, age, sex, and height; * fev1/fvc (forced vital capacity) ratio ≥70%; * smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease \[copd\], chronic bronchitis, or other relevant conditions); * non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result. exclusion criteria: * subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product; * any flu-like syndrome or other respiratory infections within 2 weeks prior to the screening visit; * history of chronic obstructive pulmonary disorder (copd) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years; * renal impairment as defined by a calculated creatinine clearance of ≤ 80 ml/minute; * history of syncope within the last 6 months.

Keywords: adults
evaluation treatment outcomes of anterior open bite treated by temporary anchorage devices

Conditions: Anterior Openbite Malocclusion

Summary: the present study will be performed to evaluate the treatment outcome of anterior open bite by temporary anchorage device on buccal and palatal mini screws


Eligibility criteria:
inclusion criteria: 1. patients age range 13-18 years old. 2. patients have anterior open bite. 3. normal healthy patient. 4. patient have healthy oral tissues. 5. patient have class i or ii jaw relationship. 6. patient have complete set of permanent teeth except the wisdom tooth. exclusion criteria: 1. uncooperative patient and parents. 2. patient who had undergo previous orthodontic treatment. 3. patient with class iii jaw relationship.
stress and brain response using meg in pws

Conditions: Prader-Willi Syndrome

Summary: individuals with prader-willi syndrome (pws) have increased hunger and food seeking behaviour, as well as learning (cognitive) challenges. in addition, some patients with pw been shown to have low cortisol production, particularly in stressful situations. however, research examining how hormonal, cognitive, and psychological factors are interrelated pws is limited. to address this gap in knowledge, the goal of this project is to understand how changes in brain regions involved in controlling food intake and cognitive processes are related to changes in hormones regulating appetite, the stress hormone cortisol, and performance on neuropsychological tests.

prader-willi syndrome (pws) is characterized by hyperphagia, although the degree of food seeking can vary between individuals. this behaviour may be moderated by hormonal, neurocognitive, and psychological factors; however, data assessing these factors in an integrated fashion is scarce. the proposed research will address and identify relationships between three major challenges in pws: 1) dysregulated feeding behaviour, 2) cognitive performance, and 3) chronic stress. the investigators will measure brain response to food cues, during a cognitive task, and at rest using magnetoencephalography (meg) in adolescents with pws and bmi-matched controls. this is an innovative design as previous studies in this population used only functional magnetic resonance imaging (fmri) to examine food cue reactivity, which does not directly measure neuronal activity and lacks temporal-sensitivity. in contrast, meg directly records neural firing and combines high spatial resolution with exquisite temporal resolution, allowing us to measure functional connectivity between brain regions. importantly, meg is also patient-friendly with fewer contraindications than mri. to assess cognitive function, the investigators will utilize gold-standard neuropsychological measures, as well as emotional and social behavioural functioning. lastly, the investigators will assess hair cortisol, which is a reflection of long term, month-by-month cortical exposure. this new area of research will explore neurobiological and cognitive mechanisms controlling feeding behaviour in pws.

Eligibility criteria:
inclusion criteria: * genetically diagnosed pws (study population) * adolescents matched for age, sex, and bmi-percentile (controls) exclusion criteria: * past or current history of alcoholism or consistent drug use * current untreated major psychiatric illness as defined by the dsm-v criteria * medications that decrease alertness (that cannot be held on the days of testing) * history of recent major head trauma * current pregnancy * diagnosis of diabetes * current or recent smoker (i.e. \>2 cigarettes/week during past year) * history of metal in body (shrapnel, metal slivers, unremovable metal adornments, clips, top braces, pacemaker) * use of glucocorticoid medications

Keywords: prader-willi syndrome magnetoencephalography food cue reactivity stress
comparison of characteristics between faller and non-faller transtibial amputees

Conditions: Amputation; Fall; Ambulation Difficulty; Quality of Life; Prosthesis User

Summary: researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.

unilateral transtibial level prosthetic users will be included in this study. after getting the fall history of subjects, those who feel at least one time or more in the last year will be accepted as the faller group. demographic characteristics, functional capacity, health-related quality of life, and prosthetic types used by amputees will be assessed. the main differences between the faller and non-faller transtibial amputees will be analyzed with the data.

Eligibility criteria:
inclusion criteria: * having the ability to walk at least 30-meter independently * using the transtibial prosthesis for at least one year. exclusion criteria: * multiple limb amputees or prosthetic users * having prosthetic discomfort or stump ulcer
the effect of oral β- glucan supplement on appetite and insulin resistance in non alcoholic fatty liver disease

Conditions: Non Alcoholic Fatty Liver Disease

Summary: the objective of this study is evaluating the effect of oral β- glucan supplement on anthropometric measurements, appetite, insulin resistance, liver echogenicity and enzymes in non alcoholic fatty liver patients treating with hypocaloric diet and vitamin e.


Eligibility criteria:
inclusion criteria: * patients with non alcoholic fatty liver disease from both sex * age 18-55 years * bmi more than 25 kg/m2 exclusion criteria: * alcohol consumption * pregnancy or lactation or menopause * being a professional athlete * a history of cancer * risk of high blood pressure (in the case of drug use) * heart disease - cardiovascular, pulmonary, renal and diabetes * liver transplantation and other chronic or acute liver diseases such as hepatitis b, c and liver infections * the history of inherited disorders affecting the liver * a history of autoimmune disease * history of food allergies * taking certain medications such as blood pressure control, statins, insulin sensitivity enhancers and hepatotoxic drugs

Keywords: non alcoholic fatty liver disease(nafld) β- glucan appetite insulin resistance
lidocaine patch for relief of pain during epidural placement in laboring patients

Conditions: Pregnant; Labor

Summary: infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. skin infiltration, although brief, can be very stressful and painful for patients.2 this initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. to reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.


Eligibility criteria:
inclusion criteria: 1. laboring patients between the ages of 18 and 45 with a bmi of less than 45 exclusion criteria:

Keywords: labor epidural
health and cardiovascular risk factors in slums.

Conditions: Cardiovascular Risk Factor; Cardiovascular Diseases

Summary: cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. people who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden. our study aim to describe the prevalence of cardiovascular risk factors and cardiovascular disease burden in a representative sample of an urban slum of buenos aires city, using validated questions from the national risk factors survey (edition 2013). also, the investigators will measure blood pressure and cardiac rate to all study participants.

cardiovascular risk factors and disease burden has been showed to affect more deeply to poorer populations. people who live in slums are the most vulnerable subgroup in the populations where, paradoxically scarcity of data exists on risk factors and cardiovascular disease burden. hypothesis: the prevalence of modifiable cardiovascular risk factors in an urban slum from buenos aires city is higher than the rest of the country and, consequently requires a distinctive management approach. objectives: 1. to measure the prevalence of cardiovascular risk factors in a representative sample of the villa 31 (an urban slum from buenos aires city). 2. to measure the self-perceived health in a representative sample of the villa 31 (urban slum from buenos aires city). design: observational study. survey. procedures: the survey will be conducted by neighbors from the slum that received specific training as community health workers and were trained on the use of the survey questionnaire and for blood pressure measuring. sampling: representative samples of slum population will be obtained using probabilistic, multi-staged sampling methods. blood pressure measures: blood pressure will be measured using automatic blood pressure monitoring device with appropriate cuff sizes. statistical analyses: categorical variables will be expressed as numbers and percentages, and continuous variable as means and standard deviations or medians and interquartile ranges. between groups comparisons will be conducted using chi2 test for categorical variables and t test or mann-whitney u's test for continuous variables. to compare the prevalence of risk factors with the rest of the country, the database will be jointed with the national risk factor survey (publicly available). all analyses will be weighted to account for the sampling method.

Eligibility criteria:
inclusion criteria: \>= 18 years. sign the informed consent. - exclusion criteria: unable to answer the survey. unwilling to participate. -

Keywords: cardiovascular risk factor slums survey cardiovascular disease
association between handgrip strength and small airway disease in patients with stable chronic obstructive pulmonary disease

Conditions: COPD

Summary: the goal of this observational study is to investigate the correlation between handgrip strength and small airway disease among patients with chronic obstructive pulmonary disease (copd). the main question it aims to answer is: • is handgrip strength correlated with small airway disease in copd patients? participants will perform handgrip strength test and impulse oscillometry (ios).

this is a cross-sectional study in copd patients. copd patients aged 40 years or older were included. handgrip strength test and impulse oscillometry will be tested in each patient. handgrip strength will be measured using a hand dynamometer. small airway disease will be assessed using ios.

Eligibility criteria:
inclusion criteria: * copd patients aged 40 years or older * confirmed diagnosis by spirometry (post-bronchodilator fev1/fvc \<0.7) * smoking history 10 pack-years or more exclusion criteria: * copd exacerbation within 3 months * inability to perform handgrip strength test or impulse oscillometry

Keywords: chronic obstructive pulmonary disease handgrip strength small airway disease airway resistance correlation
mechanism of stent thrombosis (most) study

Conditions: Coronary Artery; Stent Thrombosis; Platelet; Thrombus

Summary: this study is designed to assess the pathophysiology of st by studying the main procedural and anatomical factors involved in the genesis of st such as those related to stent and the vascular wall, as well as to the individual platelet residual reactivity.


Eligibility criteria:
inclusion criteria: * previous pci with bare metal stent (bms) or drug eluting stent (des) and a definite subacute coronary st * previous pci with des and a definite late or very late coronary st exclusion criteria: * development of st within 72 hours of stent implantation (acute and early subacute st). * late and very late st of bms. * absence of informed consent. * age less than 18 years. * creatinine values greater than 2.5 g/dl (this is to avoid the negative effects related to the contrast medium necessary to perform the oct evaluation).

Keywords: stent thrombosis percutaneous coronary intervention bare metal stent drug eluting stent residual platelet reactivity optical coherence tomography oct