Kornimate/medical-research-clean huggingface dataset:
the effect of high dose n-acetylcysteine on airtrapping and airway resistance in chronic obstructive pulmonary disease (copd) patients

Conditions: COPD

Summary: this study is to investigate the add-on effect of high dose nac (600mg tablet twice daily) on reduction of airtrapping and airway resistance in stable copd patients as well as to study it's effect in reducing exacerbation, improving exercise capacity and quality of life in stable copd patients.

background: the mucolytic and antioxidant effects of n-acetylcysteine (nac) may be of great value in treatment of copd patients. however, previous studies fail to demonstrate the beneficial effect of nac. this may be due to insufficient dose of nac used as well as inadequate outcome parameters measured in the past studies. objective of study: this study is to investigate the add-on effect of high dose nac (600mg tablet twice daily) on reduction of airtrapping and airway resistance in stable copd patients as well as to study it's effect in reducing exacerbation, improving exercise capacity and quality of life in stable copd patients. study design: randomized double blinded placebo controlled trial in kwong wah hospital methodology: patients are recruited in kwong wah hospital if they fulfill the spirometric criteria of copd. eligible subjects will be randomized into the treatment (nac 600mg tablet twice daily) and placebo group after completion of run in period. nac and placebo will be prescribed accordingly in addition to their usual therapy. both patients and investigators are blinded about the group allocation. baseline assessment will be done and patients will be followed up at 16th weeks and 52th week of the study. during each follow-up visit, hyperinflation parameters like inspiratory capacity (ic) will be measured by plethysmography. airway resistance will be measured by both plethysmography and impulse oscillometry machine. exercise capacity (6 min walking distance) and quality of life are also recorded during each follow up. the difference of the above parameters between the 2 groups (drug and placebo group) will be analyszed by the repeated measures anova test

Eligibility criteria:
inclusion criteria: * spirometry diagnosed copd with fev1/fvc ratio less than 70% and fev1 less than 80% predicted * clinically stable and exacerbation free in the past 4 weeks * history of at least one copd exacerbation in the past one year exclusion criteria: * patients allergic or intolerant to nac * recent use of nac in the past one month * history of asthma, non copd respiratory disorders like bronchiectasis, pneumoconiosis or any active pulmonary infection * patients on long term steroid * patients on long term oxygen therapy or non invasive ventilation

Keywords: copd n-acetylcysteine airtrapping airway resistance antioxidant
safety study of aem-28 to treat refractory hypercholesterolemia

Conditions: Hypercholesterolemia; Hyperlipoproteinemia Type II

Summary: the purpose of the first part of this study is to determine the safety and tolerability of a single dose of aem-28, an apolipoprotein e mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. the pharmacokinetics and pharmacodynamics of aem-28 will also be evaluated. the second part of this study will be a multiple ascending dose evaluation of aem-28 in patients with refractory hypercholesterolemia. aem-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. aem-28 is being developed for the treatment of homozygous familial hypercholesterolemia.


Eligibility criteria:
inclusion criteria: single ascending dose (sad) study: * male or female non-smoker, ≥18 and ≤55 years of age, with bmi \>18.5 and \< 32.0 kg/m² * total cholesterol greater or equal to 5.0 mmol/l (≥194 mg/dl) at screening multiple ascending dose (mad) study: * male or female non-smoker, ≥18 and ≤75 years of age, with bmi \>18.5 and \< 35.0 kg/m² * diagnosis of refractory hypercholesterolemia with ldl cholesterol levels \> 2.5 mmol/l (97 mg/ml) at screening. * on stable lipid lowering therapy for ≥ 8 weeks * on stable diet for ≥ 12 weeks. exclusion criteria: sad study: * any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis b, hepatitis c, or hiv found during medical screening. * history of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance. mad study: * significant health problems within 6 months prior to screening, which in the opinion of the medical sub-investigator would prevent the subject from participating in the study, including but not limited to: unstable coronary heart disease; transient ischemic attack; stroke; revascularization procedure; uncontrolled hyperthyroidism; coagulation disorder; peptic ulcers or gi bleeding; significant disease of the central nervous system; liver or renal disease. * history of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance.

Keywords: hypercholesterolemia apolipoprotein e first in human apolipoprotein e (apoe) apolipoprotein e mimetic (aem)
discordance of obesity in adolescent sibilngs

Conditions: Obesity

Summary: this research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight).

this research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight). to accomplish this, siblings attend four laboratory sessions where they consume one of two types of kool-aid, smell the pizza, or rest quietly. siblings then eat a dinner meal. siblings also wear an activity monitor for one week and record their physical activity and sedentary activities in a habit book.

Eligibility criteria:
inclusion criteria: * between 13-17 years old * have discordant same gender sibling (one is below 70th percentile, one is above 85th percentile * speak/read english * moderate or greater liking of study foods exclusion criteria: * no current diagnosis of a psychiatric or eating disorder. * no dieting, dietary restrictions, or allergies that would interfere with study participation. * no medications or conditions that could influence taste or appetite. * no health concern or physical disability that would limit participation in physical activity. * no endocrine or central nervous system disorder that could produce overweight. * no current use of tobacco or nicotine products by the adolescent siblings.

Keywords: siblings overweight adolescent
proprioception and sensorimotor control in hereditary sensory and autonomic neuropathy

Conditions: Atunomic Neuropathy

Summary: this project comprises three sets of physiological studies - testing eight specific hypotheses - that will contribute new knowledge on proprioception and motor control in a genetic disorder that affects specific components of the sensory nervous system. i: to investigate the neurophysiological basis for disturbed motor control in hereditary sensory and autonomic neuropathy (hsan) iii ii: to investigate the effects of enhancing cutaneous feedback on motor control in hsan iii iii: to investigate the cortical representation of proprioceptive inputs in hsan iii

hsan iii patients (n=15) and healthy control subjects (n=15) will lay supine on an mri bed and a tungsten microelectrode inserted percutaneously into a muscle or cutaneous fascicle of the right common peroneal nerve at the fibular head, according to standard techniques employed by prof macefield. neural activity will be acquired, rms-processed (200 ms) and analysed on computer. the subject's head will be tightly enclosed in a standard clinical 32-channel sense head coil and headphones will be provided to minimize noise and to allow communication with the subject. the subject will be placed in the bore of a 3t whole-body scanner for 60-90 minutes.

Eligibility criteria:
inclusion criteria: * confirmed genetic diagnosis of hsan iii will be recruited from the dysautonomia center at nyu exclusion criteria: * homeless * active drug or alcohol dependence * evidence of neurological disorder or diabetes * exposure to neurotoxic drugs that in the investigator's opinion may compromise results * pregnant women

Keywords: hereditary sensory neuropathy autonomic neuropathy familial dysautonomia proprioception motor control sensory nervous system. hsan iii ikbkap gene mutation
erlotinib in women with previously untreated adenocarcinoma of the lung

Conditions: Adenocarcinoma; Non-small Cell Lung Cancer

Summary: the purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called tarceva (erlotinib; osi-774) has on women with previously untreated adenocarcinoma.

patients will start taking tarceva daily by mouth on day 1 and will continue taking this medication daily at home, until participation in the study ends.

Eligibility criteria:
inclusion criteria: * female * diagnosis of adenocarcinoma of the lung * patient has had at least one core biopsy of her tumor * must be willing to undergo epidermal growth factor receptor (egfr) mutation testing of her tumor * stage four (iv) or three (iii) b non-small cell lung cancer * non-smoker or former smoker. non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago. * three or more weeks since last radiation therapy * three or more weeks since last major surgery * must at least be able to walk and capable of taking care of herself although unable to carry out work activities * life expectancy of 8 weeks or more * blood tests that show kidneys, liver and bone marrow to be working adequately * women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study exclusion criteria: * prior exposure to tarceva (osi-774, erlotinib) * uncontrolled central nervous system problems * prior chemotherapy regimen * difficulty swallowing * a disease or disorder that interferes with ability to digest and absorb food * incomplete healing of previous oncologic or other major surgery * significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure * pregnant or breast feeding * a medical condition that could make it unsafe for patient to participate in this study

Keywords: tarceva erlotinib osi-774 adenocarcinoma advanced lung cancer
influence of emotions on decision-making in parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease mainly affects the dopaminergic neurons of the substancia nigra, which project on the striatum. neuronal death within this structure leads to a decrease in dopamine levels. dopamine is a neurotransmitter essential to the proper functioning of the basal ganglia highly involved in the control of voluntary and involuntary movements. it also leads to cognitive and behavioral changes. among these changes, the investigators will mainly remember the idea of the emergence of difficulties to make the right decisions, for example at the financial, medical .... this disruption would be the result of executive dysfunction. by definition, executive functions allow us to evaluate, plan and organize our actions to achieve a goal.

some research shows that positive emotional states are associated with greater self-confidence, greater optimism, and better regulation of our decision-making. the goal is to test whether positive emotional induction could improve decision-making in parkinson's disease. listening to music would decrease anxiety levels and increase self-esteem levels. who says parkinson says dopamine deficiency and so the investigators can think that the investigators can help patients by inducing a positive emotion through musical stimulation. all participants will be subject to emotional induction. they will be divided into two different conditions: either they will be induced in a positive state, or they will be maintained in a neutral state. for this, video clips (positive or neutral) containing music will be presented. immediately after the presentation of the video, participants will have to perform the iowa gambling task test. this is a sequential task to evaluate decision-making capabilities.

Eligibility criteria:
inclusion criteria for patients : * diagnosis of the disease carried out by a hospital doctor * stable treatment for two months minimum. * mini-mental parkinson \> 26 * under dopaminergic treatment exclusion criteria for patients : * other neurological or psychiatric antecedents * anxio-depressive symptomatology * delusional or psychotic state inclusion criteria for witnesses : * matched in age and sex * vision and hearing normal or successfully corrected * understand the french language * general level in the test standard exclusion criteria for witnesses : * neurological or psychiatric diseases * anxio-depressive symptomatology

Keywords: influence of emotions positif emotional induction decision making iowa gambling task
cognitive-functional evaluation of anosognosia

Conditions: Anosognosia; Brain Damage

Summary: acquired brain damage patients usually show severe cognitive deficit that alter their performance on every day life activities. some of them suffer anosognosia and they are not aware of their own limitations. this situation increases disability by producing a large number of unsafe behaviours, caregivers burn-out and impede rehabilitation by affecting patients desire to follow treatment instructions. from disciplines like neuropsychology, cognitive neuroscience or occupational therapy, it is considered a crucial issue to investigate the cognitive and neural mechanisms responsible of anosognosia, as well as to increase our knowledge about the most efficient treatments to deal with this phenomenon. the main general objective of this project is to generate and validate a detailed cognitive assessment protocol within the context of adl to evaluate the different cognitive components of consciousness proposed on the toglia and kirk´s model: 1) offline componente: metacognitive knowledge and 2) online component: emergent awareness, self-regulation, anticipatory awareness, self-evaluation and updating processes).

the proposed protocol is composed by two ecological tools: the cog-awareness adl scale (adl scale of metacognitive knowledge) and the basic and instrumental adl performance based test (awareness adl), to identify the presence of cognitive deficits and anosognosia in patients with abi always within the context of everyday life activities. one first specific aim is to test the convergent validity of the two proposed ecological tools with other traditional and validated measures usually used to assess similar cognitive processes and components of self-awareness. the second specific objective is to investigate the external validity of the ecological tools, by testing whether they are able to discriminate between acquired brain damage patients with and without anosognosia and a group of neurologically healthy participants on every component. after conducting a literature review of the subject we found that this would be the first protocol developed to identify all these components in the same study.

Eligibility criteria:
inclusion criteria: * presence of an acquired brain damage objectively observed with medical reports. * cognitive deficits relative to executive functions and/or memory evaluated by the team of professionals who recruit participants in the hospital. exclusion criteria: * presence of a serious visuoperceptual deficit that makes it difficult to complete the adl tasks, evaluated by the team of professionals who recruit participants in the hospital. * presence of an understanding deficit (aphasia) evaluated by the team of professionals who recruit participants in the hospital. * presence of spatial neglect evaluated with line cancellation and line bisection tests. * presence of motor deficits in both upper limbs that impedes to complete the adl tasks. * total score in mmse\<18

Keywords: activities of daily living (adl) executive deficit monitoring self awareness
web-based cbt protocol for treatment of selective mutism

Conditions: Selective Mutism

Summary: the main aim of this study is to examine the effectiveness of a web-based cbt protocol (entitled meeky mouse) in the treatment of children with selective mutism in singapore. the researchers hypothesized that the meeky mouse program would be associated with higher frequency of speaking behaviors, lower levels of anxiety, greater improvements in clinician-rated severity of mental illness, and higher clinician-rated improvement scores at post-treatment.


Eligibility criteria:
inclusion criteria: * 6-12 years old * primary clinical diagnosis of selective mutism * confirmed diagnosis of selective mutism by structured clinical parent interview * fluent in english exclusion criteria: * below average intellectual functioning * the presence of autism and schizophrenia

Keywords: anxiety frequency of speech selective mutism
defense and veterans center for integrative pain management (dvcipm) pain registry biobank

Conditions: Pain

Summary: this pain registry biobank is a prospective cohort design study whereby data (pastor survey, blood and saliva specimens, clinical data) is collected from participants in a longitudinal fashion with continual enrollment.

the defense and veterans center for integrative pain management (dvcipm) established a clinical data registry and tissue biobank (pain registry/biobank) for the advancement of pain-related research. this pain registry biobank will address the complexity of pain by utilizing the pain assessment screening tool \& outcomes registry (pastor), a thorough biopsychosocial assessment that extends beyond a single-item pain rating scale. pastor is an assessment battery that includes several patient reported outcomes measurement information system (promis) scales developed by the national institutes of health (nih) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments. as a uniform assessment system, pastor also mitigates a significant challenge in pain-related research, the lack of standardized, cross-study outcomes. additionally, the richness of pastor data matched with biological samples allows future researchers to address significant research gaps and enhance health care for service members, veterans, and civilians.

Eligibility criteria:
inclusion criteria: * eligibile for care within the military healthcare system * able and willing to provide written consent exclusion criteria: * cannot understand english

Keywords: pain pastor biobank
reduce ventricular pacing in dual chamber implantable cardioverter defibrillators using autointrinsic conduction search study

Conditions: Arrhythmia

Summary: the purpose of this study is to determine if patients implanted with a st. jude medical (sjm) implantable cardioverter defibrillator (icd) will benefit by using autointrinsic conduction search (aics) rather than only a programmed av/pv delay. this study will compare the two methods of programming with respect to intrinsic activity.


Eligibility criteria:
inclusion criteria: * patient has been implanted with a dual chamber sjm icd with aics for 1 month (± 2 weeks). * at the time of enrollment, patient is paced in the right ventricle (rv) ≤25% of the time as determined by the device diagnostics. * patient is medically stable. exclusion criteria: * patient has evidence of atrioventricular (av) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management * patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons. * patient is younger than 18 years of age. * patient is pregnant.

Keywords: icds ventricular pacing patient has been implanted with a dual chamber sjm icd with aics for 1 month (± 2 weeks). at the time of enrollment, patient is paced in the rv ≤25% of the time as determined by the device diagnostics. patient is medically stable.
treatment of acetabulum fracture with o'arm surgical imaging

Conditions: Acetabulum Fracture

Summary: acetabulum fracture are high energy trauma in young people as it can be the result of a simple fall in elder people. this fracture generates an incongruity between acetabulum and femoral head. so surgery is recognized as the best treatment even if technically difficult because of the the complexity of anatomy.navigation is widely used in orthopaedic surgery . the aim of the study is to evaluate the effect of peroperative navigation system on reduction of the acetabulum articular surface


Eligibility criteria:
inclusion criteria: * age \>18 years * acetabulum fracture dating less than a month exclusion criteria: * no exclusion criteria

Keywords: o'arm
effect of sitagliptin on postprandial lipoprotein metabolism

Conditions: Diabetes Mellitus Type 2

Summary: the goal of the study is to evaluate whether sitagliptin can affect postprandial lipoprotein metabolism in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * dietary therapy exclusion criteria: * lipid-lowering therapy * anti-hyperglycemic drug therapy
neuropsychiatric effects of deep brain stimulation in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: stimulation of the subthalamic nucleus will have effects on various aspects of neuropsychiatric function.


Eligibility criteria:
inclusion criteria: * participants diagnosed with idiopathic parkinson's disease that meet criteria for treatment of their disease with stn-dbs. participants will be selected for this study without regard for age (provided they are older than 18), gender or ethnic background. * participants must have undergone subthalamic nucleus dbs surgery and be receiving treatment at the scripps clinic in la jolla, ca exclusion criteria: * patients under 18 years old. * patients with mini-mental status scores below 26/30. * patients with known psychiatric disease. * patients who are too infirm, demented or dysarthric to clearly understand the consenting process, task instructions, or to communicate verbally regarding participation or non-participation.

Keywords: deep brain stimulation subthalamic nucleus
safety and ocular pharmacokinetics after 1 drop of t1225 0.5, 1 and 1.5% in 48 healthy volunteers

Conditions: Eye Infections, Bacterial

Summary: to compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of t1225.

the present phase i clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of t1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 45 years old; * written informed consent; * healthy volunteers (without any ocular symptom); * normal ocular examination in both eyes (corrected visual acuity (va) \>= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (but) \>= 10 seconds - lachrymal secretion in the schirmer test \>= 10 mm in 5 minutes - lissamine green test total score \< 4). exclusion criteria: * ocular trauma, infection or inflammation within the last 3 months; * conjunctival hyperaemia score \>= 2, watering score \>= 2, folliculo-papillary conjunctivitis score \>= 2, number of fluorescein-stained punctuations \>= 10; * blepharitis, conjunctivitis, uveitis; * ocular laser treatment within the last 3 months; * ocular surgery, including lasik and prk, within the last 12 months; * topical ocular treatment during the last month; * ocular antibiotics within the last 7 days; * medication during the study (except paracetamol and contraceptives).