Kornimate/medical-research-clean huggingface dataset:
speed of processing training to improve cognition in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this research study is to investigate the effectiveness of a computerized technique designed to improve processing speed (i.e. the amount of time it takes for a person's brain to process information) in a multiple sclerosis (ms) population. the study is designed to study how well this technique can help people with ms increase their processing speed and their ability to function better in everyday life. this treatment protocol has been studied extensively with older adults, showing improvements on standard laboratory measures of processing speed and performance of activities of daily living.

this study is a double-blind, placebo-control randomized clinical trial examining the efficacy of speed of processing training (spt) for improving processing speed (ps) deficits in persons with multiple sclerosis (ms). slowed ps is one of the most common deficits in individuals with ms and such deficits have been shown to exert significant negative impact on multiple aspects of everyday life, including occupational and social functioning. despite these findings, few studies have attempted to remediate ps deficits in order to improve the everyday functioning of individuals with ms. this study is designed to (1) apply a treatment protocol for ps impairments well-validated in an aging population to individuals with ms with objectively observable deficits in ps and document its efficacy on standard neuropsychological outcome measures. in addition, the investigators will (2) assess the effectiveness of the intervention utilizing global measures of everyday life, including an objective measure (the timed activities of daily living; tiadl), as well as additional questionnaires to be completed by both the participant and a significant other. this study is also designed to (3) examine the influence of degree of ps impairment on treatment efficacy using neuropsychological tests, (4) evaluate the long-term effects of the treatment protocol and (5) examine the utility of booster sessions to facilitate long-term treatment effects.

Eligibility criteria:
inclusion criteria: * english as a primary language * diagnosis of multiple sclerosis * processing speed impairment (based on evaluation) exclusion criteria: * most recent exacerbation within one month * currently taking steroids or benzodiazepines * history of significant psychiatric illness (bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of major depressive disorder * significant alcohol or drug abuse history

Keywords: processing speed intervention multiple sclerosis cognition
a pilot study on the use of prophylactic antibiotics for eus-guided pancreatic cyst aspiration

Conditions: Pancreatic Cysts

Summary: our hypothesis is that a single dose of antibiotics at time of eus-guided pancreatic cyst aspiration is equally effective to the usual regimen of 3 days of post-procedural antibiotics.

with the increased use of cross sectional imaging, there appears to be an increasing prevalence of pancreatic cysts being incidentally discovered. a critical step in the workup of pancreas cysts is to determine whether the cyst is mucinous or non-mucinous, through a procedure called endoscopic ultrasound - fine needle aspiration (eus-fna). current guidelines suggest the use of antibiotics in cyst aspiration, usually 3 days after the procedure. however, these recommendations are based on limited data from over 15 years ago. more recent retrospective observations suggest equivalent safety when little, or even no antibiotics are given.

Eligibility criteria:
inclusion criteria: * patients between the age of 18-90 who present for an eus / pancreas cyst evaluation exclusion criteria: * patients outside the age range * patient-related factors (unable to provide consent, unable to understand english, allergic to cipro) * high-risk patients for infective endocarditis * bacterial infection or use of antibiotics within 6 weeks of eus * pancreatitis within the past 6 months * underlying immunosuppression (for example, uncontrolled diabetes - such as hemoglobin a1c above 7 or glucose \> 180; renal failure; cirrhosis; pre-existing malignancy especially hematologic malignancy such as leukemia / lymphoma / multiple myeloma; hiv/aids) * currently taking immunosuppressive medications (for conditions such as rheumatoid arthritis, inflammatory bowel disease, organ transplant) * radiographic or endosonographic evidence of cyst cavity debris / necrotic debris * severe systemic disease (for example, nyha class iii or iv heart failure, oxygen-dependent copd)
efficacy of inhaled nitroglycerin in moderate to critically ill covid-19 patients

Conditions: Corona Virus Infection

Summary: in current analysis moderate to severely ill covid-19 infected patients will be nebulized with nitroglycerin, and they will be compared with the standard nebulization


Eligibility criteria:
inclusion criteria: diagnosed admitted cases of covid-19 degree of illness should be moderate to severe both male and female every age group exclusion criteria: allergic to nitroglycerin sudden drop in blood pressure not given consent
mk0954a-264 filter study (0954a-264)(completed)

Conditions: Mild to Severe Hypertension

Summary: to compare the blood pressure lowering efficacy, safety and tolerability of a combination drug to a single drug taken once daily in patients with uncontrolled blood pressure following a 4-week filter on the single therapy product.


Eligibility criteria:
inclusion criteria: * male and female patients with mild to severe hypertension (sidbp 90-120 mmhg) exclusion criteria: * systolic bp \> 200 mmhg * secondary or malignant hypertension * taking more than 2 antihypertensive medications * hypertension induced by oral contraceptives * hx of cerebral vascular accident within 6 months * hx of angina, myocardial infarction, pci, cabg, or decompensated chf within 6 months * clinically significant av conduction disturbance or potentially life threatening ventricular arrhythmias, valvular disease, cardiomyopathy, unexplained syncope * history of angioedema * sensitivity to aii receptor antagonists or hctz, nephrotic syndrome,single kidney function * pregnancy or lactation.
36-month post-marketing surveillance and analysis of menactra vaccine in 2-10 year olds

Conditions: Meningitis; Meningococcal Disease

Summary: to further characterize the safety profile of menactra vaccine and to identify any signals of potentially vaccine-related adverse events (aes) not detected during pre-licensure studies.


Eligibility criteria:
inclusion criteria: * receipt of menactra vaccine during the study period. exclusion criteria: * none

Keywords: meningitis meningococcal disease menactra vaccine
effect of low carbohydrate versus low fat diet in the treatment of dyslipidemia in obese children with metabolic syndrome

Conditions: Metabolic Syndrome; Obesity; Dyslipidemias

Summary: two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks.

two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8 weeks. anthropometric evaluations, lab work for lipid levels, insulin and c peptide levels, resting energy expenditure evaluation, dxa scan and cardiovascular markers will occur at baseline during the initial clinic visit. individual dietary counseling will be provided at baseline and as well as weekly diet-specific support will be provided with a phone call from the pi. dietary intake will be assessed with weekly food records (weeks 1-8). the return visit on week 8 will include a visit identical to the initial visit except the resting energy expenditure will not be revaluated, and the participants will be asked to answer a questionnaire about the diet they were consuming.

Eligibility criteria:
inclusion criteria: 3 out of 5 of the following criteria * metabolic syndrome with dyslipidemia * (hdl \<40mg/dl * triglyceride (tg) tg\>150mg/dl) * glucose intolerance (fasting blood sugar \>100mg/dl) * central adiposity (waist circumference ≥90th percentile or adult cutoff if lower) * systolic bp ≥130 mm hg or diastolic bp ≥85 mm hg or treatment of previously diagnosed hypertension exclusion criteria: * patient on medications known to induce dyslipidemia (systemic steroids, immunosuppressants) * pregnancy * untreated thyroid disease, heart disease, cancer, kidney disease * children on statin/fibrate treatments or other lipid-lowering medications * prior surgical procedure for weight control or current weight loss medication

Keywords: dietary intervention anthropometric measure lipid profile augmentation index flow mediated dilation dxa scan nuclear magnetic resonance lipid profile
autophagy maintains vascular function through a novel glycolysis-linked pathway regulating enos

Conditions: Vascular Diseases

Summary: aging is inevitable and is the primary risk factor for developing cardiovascular disease. the molecular mechanisms that drive vascular dysfunction in the context of aging are incompletely understood. the overall hypothesis is that the age-related decline in endothelial cell (ec) autophagy leads to arterial dysfunction. this study will determine whether physiological shear-stress affects autophagosome formation and nitrous oxide (no) generation in ecs.

it is hypothesized that genetic autophagy suppression prevents shear-stress induced purinergic signaling to endothelial nitrous oxide synthase (enos) and this pathway will be evaluated in primary arterial ecs obtained from older adult (\> 60 years) and adult (18-30 years) subjects before and following rhythmic handgrip exercise that elevates brachial artery shear-rate similarly in both groups. ecs will be used to quantify markers of ec autophagy, enos activation, and no generation. the study will also determine whether exercise-training attenuates the aging-associated decline in ec autophagy, and whether intact autophagy is required for training-induced vascular improvements. to evaluate this potential, it will be determined whether one-limb rhythmic handgrip exercise training by older adult (\> 60 y) human subjects is sufficient to elevate basal and shear-induced ec autophagy initiation, enos activation, and no generation vs. the contralateral sedentary limb. results from this work have tremendous potential to reveal a new therapeutic target and approach for restoring / maintaining vascular function in the aging population.

Eligibility criteria:
inclusion criteria: * candidates must be between 18 and 90 y of age * candidates must be free of overt disease as assessed by a) medical history; b) standard blood chemistries (chem. 7 panel), c) ecg at rest; d) limb vascular examination (ankle-brachial bp index \> 0.9); e) resting bp \< 140/90 mmhg; and f) skinfold % body fat assessment. * subjects will have a body mass index (bmi) between 19 and 30 and have plasma glucose concentrations \< 7.0 mmol/l under fasting conditions and \< 11.1 mmol/l at 120 minutes of an oral glucose tolerance test (ogtt) exclusion criteria * candidates \ 90 y of age * candidates demonstrating abnormal ecg, ankle-brachial bp index \ 140/90 * candidates demonstrating a bmi \ 30 * candidates demonstrating plasma glucose concentrations \> 7.0 mmol/l under fasting conditions and \> 11.1 mmol/l at 120 minutes of an oral glucose tolerance test (ogtt) * candidates demonstrating dyslipidemia (plasma total cholesterol \> 240 mg/dl with ldl-cholesterol \> 160 mg/dl) * candidates reporting a history of myocardial infarction, unstable cardiac ischemia, recent cardiac catheterization, carotid artery disease, transient ischemic attack * women taking hormone replacement therapy (hrt) currently or in the preceding year will be excluded from the proposed studies due to the direct vascular effects of hrt.

Keywords: aging endothelial cell autophagy
music therapy: sickle cell and pain crisis

Conditions: Sickle Cell Crisis; Functional Abdominal Pain; Patients Followed by the Pain Team

Summary: this study will assess whether participants who receive music therapy during inpatient care report a decrease in pain and whether music therapy influences factors such as family satisfaction.

the purpose of this study is to determine if music therapy services can serve as a viable, necessary, and beneficial aspect of inpatient pain management, distraction, and coping for pediatric patients in the acute care hospital setting. the investigator will note the effect of music therapy services in conjunction with pain scores reported by the participant and an increase in self and family reported coping skills during hospitalization. participants will be referred by providers from pain management service, oncology/hematology service, or the gastrointestinal (gi) service for functional and abdominal pain. participants who meet the criteria for inclusion will be selected. the study will be explained to parents and a consent form will be left for the family to review and sign at their convenience. participants will provide a pain scale level and vitals before completing the music therapy intervention. once the music therapy intervention is completed, the pain scale and vitals will be repeated.

Eligibility criteria:
inclusion criteria: * 5-17 years of age * admitted for sickle cell crisis, functional abdominal pain, or whom the pediatric pain management team is following. exclusion criteria: * non-english speaking * under 5 years old and over 17 years old * patients who are unable to hear or have a hearing disability * developmentally unable to self-report pain levels
effect of a novel protein supplement on appetite in older adults

Conditions: Aging; Appetite Loss

Summary: an acute randomized crossover trial comparing the effects of the whey hydrolysate, whey protein concentrate and placebo (still flavored water) on appetite and energy intake in older adults. both low-dose whey-derived treatment and placebo will be administered 30 minutes prior to breakfast and lunch meals. moreover, ghrelin secretion and activity will be monitored throughout the morning until the lunch time. appetite will be assessed through visual analogue scale questionnaires.


Eligibility criteria:
inclusion criteria: * community-dwelling, * age 60+ years * poor appetite (simplified nutritional appetite questionnaire (snaq) score \</=14, answer a, b or c to q.1 on snaq or answer b, c, or d to ces-d question regarding poor appetite in the past week) * bmi 20-25kg/m2 exclusion criteria: 1. current medical condition or medication known to impact appetite or energy intake 2. other medical condition that would impact study participation and outcomes, as judged by the study investigator. 3. heavy smoker (\>10/day) 4. inability to come to study centre 5. currently participating in another intervention study 6. lacking informed consent 7. allergic to or unwilling to consume any of the study test foods 8. loss of taste or smell associated with covid-19 9. unable to walk across a room

Keywords: appetite poor appetite ageing whey protein hydrolysate visual analogue scale energy intake ghrelin
two investigational drugs in patients with mixed hyperlipidemia (0653-036)

Conditions: Hypercholesterolemia; Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the cholesterol lowering effectiveness and safety of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).

the duration of treatment is 18 weeks.

Eligibility criteria:
inclusion criteria: * high cholesterol and high triglycerides exclusion criteria: * patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Keywords: mixed hyperlipidemia high cholesterol high triglycerides
pre-gene therapy study in parkinson's disease and multiple system atrophy

Conditions: Parkinson's Disease; Multiple System Atrophy, Parkinson Variant; Multiple System Atrophy

Summary: the objective of this study is to describe disease progression in study participants diagnosed with early parkinson's disease or multiple system atrophy - parkinsonian type up to 18 months as delineated by clinical and biochemical parameters.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd * diagnosis of msa-p * one to six years from clinical diagnosis of pd * less than 4 years from clinical diagnosis of msa with expected survival \>3 years * stable medication regimen * ability to walk with or without an assistive device exclusion criteria: * movement disorder due to known cerebrovascular disease, brain tumor, trauma, exposure to parkinsonian-linked toxicants or other neurological diseases * presence of dementia, psychosis, substance abuse or poorly controlled depression * prior brain surgery (i.e. deep brain stimulation) or other brain imaging abnormalities * history of cancer or poorly controlled medical conditions * receiving an investigational drug note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: msa msa-p pd observational natural history
screening and intervention reducing anxiety in patients with implanted cardioverter defibrillator (icd)

Conditions: ICD; Cognitive Therapy; Anxiety

Summary: the hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. the aim of this randomised trial is (i) to determine the type of anxiety in icd patients and (ii) to investigate the effect of screening followed by randomisation to intervention with consultations based on cognitive therapeutic principals to reduce anxiety in patients with icd or usual care.

screen-icd is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including two university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone. the intervention: all patients receive usual care. patients in the intervention group will receive an intervention based on cognitive behavioral therapy. the intervention consists of three steps: 1. the intervention begins with a consultation with a nurse aiming at uncovering anxiety using the hamilton anxiety scale and exploring how life with an icd is perceived, 2. based on the pre-specified protocols for each type of anxiety, cognitive therapy is provided and 3. after each session participants are asked to fill out the hads questionnaire. when the patient scores below the cut-off value two times in a row, sessions will end. each patient can have a maximum of 15 sessions.

Eligibility criteria:
inclusion criteria: * over 18 years * have had icd implantation * speaks and understands danish * scores 8 or more in the hads-a questionnaire * gives written informed consent exclusion criteria: * scores 11 or more in the hads-d questionnaire and the depression score exceeds the anxiety score.
fasting-associated immune-metabolic remission of diabetes

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: people with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last 4 years had a remission (hba1c \ 8 years and oral treatment as primary end points. the immune metabolic programming of circulating monocytes will be investigated in detail regarding trained innate immunity and the endocrine responses will be determined using meal challenge tests.

a remission of type 2 diabetes can be achieved in over 80% of people with a diagnosis within the last 4 years and overweight or obesity by weight loss of 15 kg. the mechanisms involve an improvement of insulin sensitivity and thereby insulin requirements and a regain of the function of insulin secreting beta cells. longer duration of type 2 diabetes appears to impair the capacity of beta cell to regenerate. at present it is not possibe to predict success of the weight loss at an early time point. the investigators therefore aim to identify early markers of responders. it is unclear how the weight loss induces the remission in responders. immune cells are known to contribute to insulin resistance by regulating adipose tissue function and hepatic and skeletal muscle metabolism by releasing cytokines. the inborn immune system is known to adapt to external stimuli by the process of trained immunity and is thought to contribute to insulin resistance and the dysfunction of beta-cells. the investigation will analyze the programming state of innate immune cells in detail in the course of diabetes remission. in addition, islet hormone responses to challenge tests will be performed to assess their function in detail.

Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosed less than 4 or over 8 years, before study, * bmi \> 28 kg/m², * willingness to follow weight loss diet, exclusion criteria: * consuming disease, * intolerance for very low calorie formula diet, * known severe hepatic disease or liver cirrhosis, * type 1 diabetes, * severe disease of kidney or heart, * advanced diabetic retinopathy, * intake of glucocorticoids, * drug or alcohol abuse, * weight loss of \>5 kg in the last 3 month, * eating disorder

Keywords: type 2 diabetes mellitus in obese insulin secretion innate immunity monocyte programming remission of type 2 diabetes weight loss
a comparison of antiplatelet therapies in asian subjects with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the study will compare the safety and efficacy of prasugrel, administered at different doses with clopidogrel in the treatment of asian participants with acute coronary syndrome (acs) undergoing percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * a person who has been diagnosed with acute coronary syndrome (acs) and is to undergo a percutaneous coronary intervention (pci) * a person who is of east or southeast asian descent * a person who is of the legal age of 18 (or age 21 in singapore) and is mentally competent to provide a signed written informed consent before entering the study * if a woman is of childbearing potential, she must test negative for pregnancy and agree to use a reliable method of birth control exclusion criteria: * a person who has a severe cardiovascular condition such as cardiogenic shock at the time of randomization, ventricular arrhythmias or congestive heart failure * a person who is at an increased risk of bleeding (e.g. active internal bleeding, history of bleeding disorder, recent fibrinolytic therapy before randomization into the study) * a person who has prior history of any one of the following: ischemic or hemorrhagic stroke; intracranial neoplasm, arteriovenous malformation, or aneurysm; prior history of transient ischemic attack (tia) * a person who needs to take other antiplatelet therapy other than aspirin for the duration of the study * a person who receives daily treatment with nonsteroidal anti-inflammatory drugs (nsaids) or cyclooxygenase-2 (cox2) inhibitors that cannot be discontinued * a person who has a severe liver disease, such as cirrhosis * a person who has a condition such as alcoholism, mental illness, or drug dependence