Kornimate/medical-research-clean huggingface dataset:
study of azilect® (rasagiline) in levodopa-treated parkinson's disease patients with motor fluctuations in korea

Conditions: Parkinson's Disease

Summary: to evaluate the efficacy of a fixed dose of azilect® (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily off time during 18 weeks of treatment in levodopa-treated parkinson's disease (pd) patients with motor fluctuations in korea.

levodopa has been the mainstay therapy for pd for decades, and it is considered to be one of the most effective medications for relief of the symptoms of pd. however, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. a major problem is the appearance of fluctuations in mobility, cycles of on and off periods. the administration of azilect®, a monoamine oxidase type b (mao-b) inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve on-off fluctuations. azilect® is approved for treatment of pd in europe and the us. the objective of this study is to evaluate the efficacy, tolerability, and safety of azilect® compared to placebo in korean pd patients with motor fluctuations on levodopa therapy.

Eligibility criteria:
inclusion criteria: * patients with idiopathic pd * patients with motor fluctuations averaging at least 1 hour daily in the off state during the waking hours (not including morning akinesia) * patients with a modified hoehn and yahr stage \<5 in the off state * patients taking optimised levodopa/dopa decarboxylase inhibitor (ddi) therapy for at least 14 days prior to baseline * patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa * patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation exclusion criteria: * patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation * patients taking any disallowed medication according to the azilect® approved label * patients taking mao inhibitors within 3 months prior to baseline visit * patients with a known serious adverse reaction to selegiline * patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study * patients with a mini mental state examination (mmse) score \<=24 * patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion

Keywords: azilect motor fluctuations parkinson´s disease rasagiline
maxomat ® in the treatment of severe early onset intrauterine growth retardation on pre-pubertal children

Conditions: Fetal Growth Retardation

Summary: 1. to test for equivalence in terms of catch-up growth between the 2 therapeutic regimens 2. to specify the best period of treatment 3. to assess the efficacy of treatment based on final adult height of these children


Eligibility criteria:
inclusion criteria: * pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (i.u.g.r.) * height less than or equal to -3 sd exclusion criteria: * age less than 3 years the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
hiv-1 viral dynamics in subjects initiating raltegravir therapy in spain

Conditions: HIV Infections

Summary: the study purpose is to investigate plasma hiv-1 rna dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular hiv-1 dna.

first- and second-phase decay rates of plasma hiv-1 rna and changes in the intracellular levels of hiv-1 proviral dna and ltr circles will be measured in subjects starting salvage antiretroviral therapy including raltegravir in spain.

Eligibility criteria:
inclusion criteria: * patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance. * subjects initiating raltegravir plus another fully active antiretroviral drug. exclusion criteria: * pregnancy, or fertile women willing to be pregnant. * active substance abuse or major psychiatric disease.

Keywords: raltegravir hiv dynamics viral load treatment experienced
nitroprusside for prevention of no-reflow in primary angioplasty

Conditions: Myocardial Infarction

Summary: in patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. the study is aimed at examining whether nitroprusside, an anti-hypertension medication, given directly into the coronary artery, can improve the blood flow after the removal of the obstruction that caused the infarction.

inadequate myocardial tissue perfusion despite successful relief of the culprit occlusion and restoration of epicardial coronary flow for st-segment elevation acute myocardial infarction (stemi) results in poor outcome. the investigators hypothesized that nitroprusside (ntp) injected intracoronary immediately before angioplasty might prevent no-reflow and improve vessel flow and myocardial perfusion.

Eligibility criteria:
inclusion criteria: * acute st elevation myocardial infarction (mi) patients planned for primary pci * diagnostic angiography demonstrating a timi flow grade \<3 in the coronary artery before the pci exclusion criteria: * an admission electrocardiogram (ecg) showing complete left bundle branch block or a paced rhythm * systolic blood pressure \< 90 mmhg * a history of coronary bypass operation * a known allergic reaction to nitroprusside * chronic hemodialysis * intravenous drug abuse * pregnancy * rescue intervention after failed thrombolysis * contraindications to aspirin or clopidogrel * need for emergent coronary artery bypass surgery * inability to provide informed consent

Keywords: myocardial infarction angioplasty nitric oxide prevention acute myocardial infarction
patients with low-grade non-hodgkin's lymphoma previously treated with tositumomab and/or iodine i 131 tositumomab

Conditions: Lymphoma, Non-Hodgkin

Summary: this is a study for the long-term follow-up of patients who completed at least two years of follow-up after treatment with tositumomab and/or iodine i 131 tositumomab (bexxar)on study rit-i-000, rit-ii-001, rit-ii-002, rit-ii-004 or cp-97-012. all patients will be assessed for survival and disease status, including subsequent therapy for nhl, and for long term safety. laboratory evaluations consisting of a tsh level (for all patients) and a complete blood cell (cbc) count with a differential and platelet count (for patients in continuing response only) will be obtained annually through year 10 post treatment with tositumomab and/or iodine i 131 tositumomab. patients that remain in response to their previous treatment with bexxar, will additionally be followed radiographically for response and progression.


Eligibility criteria:
inclusion criteria: * patients must have enrolled in one of the following corixa sponsored clinical trials: rit-i-000, rit-ii-001, rit-ii-002, rit ii-004 or cp-97-012 and are \>2 years post tositumomab and/or iodine i 131 tositumomab administration. * patients must give written informed consent by signing an irb/ethics committee approved consent form prior to entry on this follow-up study. exclusion criteria: * inability to meet the above referenced inclusion criteria.

Keywords: bexxar tositumomab iodine i 131 tositumomab low-grade follicular lymphomas
safety and efficacy of methylene blue combined with artesunate or amodiaquine for malaria treatment in children of burkina faso: a pilot study

Conditions: Malaria

Summary: the primary objective of this trial is to study the safety of the combination methylene blue (mb)-artesunate (as) and mb-amodiaquine (aq) in treating malaria among children compared to the safety of an as-aq regimen. the secondary objective is to investigate the efficacy of mb-as and mb-aq.

objectives: the primary objective of this trial is to study the safety of the combination methylene blue (mb)-artesunate (as) and mb-amodiaquine (aq) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days as-aq regimen. secondary objectives are to investigate the efficacy of mb-as and mb-aq. population: children aged 6-10 years with uncomplicated malaria from nouna town. sample size: n= 180 (n=60 for each group). treatment: the participants in the mb-as group will receive orally twice daily 9mg/kg mb combined with once daily 4mg/kg as over 3 days. the participants in the mb-aq group will receive orally twice daily 9mg/kg mb combined with once daily 10mg/kg aq over 3 days. the participants of the comparator group will receive a 3 day regimen of once daily oral as (4mg/kg) combined with once daily aq (10mg/kg). endpoints: the primary endpoint is the number of adverse events (ae) after drug intake until day 28. secondary endpoints are the number of serious adverse events (sae), adequate clinical and parasitological response (acpr) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.

Eligibility criteria:
inclusion criteria: * 6-10 year old children * ability to swallow tablets * uncomplicated malaria caused by p. falciparum * asexual parasites ≥ 2000/µl and \< 200000/µl * axillary temperature ≥ 37.5°c * burkinabe nationality * informed consent exclusion criteria: * complicated or severe malaria * any apparent significant disease * anaemia (haematocrit \< 21%) * treated in the same trial before * antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine

Keywords: malaria africa methalyne-blue artesunate amodiaquine
pediatric normative markerless movement analysis

Conditions: Pediatric ALL; Adolescent

Summary: the objective of this project is to collect baseline data from a normative population of children that gender and age matches the population of patients expected to be treated by mary bridge children's research \& movement lab. this project seeks to recruit 20 male and 20 female typically developing individuals, between the ages of 3 and 25 years of age. non-invasive measurements of movement patterns (motion analysis and force plate data) will be collected during bipedal gait.


Eligibility criteria:
inclusion criteria: * age: 3-25 years of age (with 3 and 25 year olds considered for inclusion). * ambulate independently and without the use of assistive devices or orthoses. * willing and interested in participating. exclusion criteria: * neuromuscular disorders such as cerebral palsy, muscular dystrophy, myotonic dystrophy, spinal muscular atrophy, peripheral neuropathy, or other generalized muscle and/or nerve issues. * evidence of developmental delays, muscle weakness, decreased muscle tone, joint stiffness, muscle or bone deformity. * currently using or has a history of using assistive technology devices, bracing/orthoses, manual or powered mobility equipment. * history of premature birth. * currently or has a history of taking medication or pharmaceutical treatment related to musculoskeletal side-effects/scenario/diagnosis.

Keywords: motion analysis kinetics kinematics
a web-based observational study of patient-reported outcomes in adults with narcolepsy

Conditions: Narcolepsy

Summary: nexus is a collaboration between academic institutions, advocacy and industry to answer important questions about narcolepsy. it is a web-based observational study of patient-reported outcomes in adult patients with narcolepsy, with follow-up every six months. nexus website: www.narcolepsyregistry.com


Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosed with narcolepsy by a doctor
post-prandial glycaemic controlling effects of bsg in singapore adults with metabolic syndrome

Conditions: Metabolic Syndrome; Diabetes; Diet Modification

Summary: the purpose of this study is to assess the glycaemic controlling effects of bsg and bio-transformed bsg-containing biscuits in singapore adults with mets. the investigators hypothesized that consumption of bsg and bio-transformed bsg containing biscuit will improve glycaemic control.

this is a double-blind, randomised, crossover experiment. during the 3-week, 19 subjects will participate in a 3 meal tolerance test (mtt). during each mtt session, all subjects are required to consume 90 g biscuits (either control, autoclaved bsg or bio-transformed bsg biscuits) and monitored over a period of 240 minutes. all three types of biscuits will be consumed at a randomised sequence during this 3-week period. post-prandial blood glucose, insulin, lipid and amino acid responses, breath analysis, body composition, blood pressure, appetite assessment, and any other glycaemic biomarkers will be assessed.

Eligibility criteria:
inclusion criteria: * male and female participants, aged 35-85 years old * english-literate and able to give informed consent in english * willing to follow the study procedures * meet any 3 of the 5 following ncep-atp iii mets criteria: waist circumference \> 102 cm (male), \> 88 cm (female) (for asian population: waist circumference \> 90 cm (male), \> 80 cm (female)); fasting glucose concentration ≥ 100 mg/dl or on medication; triglyceride ≥ 150 mg/dl or on medication; high density lipoprotein cholesterol (hdl) \ 130/85 mmhg or on medication); exclusion criteria: * significant change in weight (≥ 3 kg body weight) during the past 3 months * allergy to barley, wheat, corn, egg, or other ingredients found inside the biscuits. * acute illness at the study baseline * exercising vigorously\* over the past 3 months. \*defined as having \> 6 metabolic equivalents of exercise daily; approximately 20 mins of moderate intensity exercise (e.g. slow jogging) a day * following any restricted diet (e.g. vegetarian) * smoking * have a daily intake of more than 2 alcoholic drinks per day * taking dietary supplements or food which may impact the outcome of interests (e.g. fermented foods, probiotic supplement etc.) * consumption of antibiotics over past 3 months. * pregnant, lactating, or planning pregnancy in the next 6 months * insufficient venous access to allow the blood collection * prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 3 years prior to the intervention participation * high current intake of fibre\* from brown rice or wholemeal products. \*high, moderate or low intake taken as ≥ 6 servings, 4 - 5 servings, and ≤ 3 servings daily respectively based on my healthy plate guidelines * high current intake of fibre\* from vegetables. \* high, moderate or low intake taken as ≥ 2 servings, 2 servings, and ≤ 1 serving respectively based on my healthy plate guidelines

Keywords: metabolic syndrome middle-aged and older adults post-prandial glycaemic response bio-transformed food
a study to evaluate pf-05175157 in healthy volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: the primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of pf-05175157 in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests. * in addition, subjects must have normal pulmonary function tests and normal ocular examination. * body mass index of 20.0 35.0 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * evidence or history of any chronic ongoing or current pulmonary disease. * history of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of screening or positive cotinine test at screening or day 0. * active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Keywords: phase 1 single doses pharmacodynamics healthy volunteers
shoulder pain and scapular endurance

Conditions: Musculoskeletal Pain Disorder; Sport Injury

Summary: objective: this study aimed to investigate the effects of regular exercising on scapular muscle endurance and shoulder pain in young individuals. methods: participants' clinical and sociodemographic properties recorded, scapular muscle endurance assessed with scapular muscular endurance (sme) test, and shoulder pain severity questioned using the visual analogue scale.

background: serratus anterior and trapezius muscles are the most important stabilizers of the scapulothoracic joint. the inadequate endurance of these muscles plays an important role in the decreased neuromuscular performance. objective: this study aimed to investigate the effects of regular exercising on scapular muscle endurance and shoulder pain in young individuals. methods: participants' clinical and sociodemographic properties recorded, scapular muscle endurance assessed with scapular muscular endurance (sme) test, and shoulder pain severity questioned using the visual analogue scale.

Eligibility criteria:
inclusion criteria: for exercise group; * between 17-25 years ages * who were using the fitness center by their preference (not professional) * had active sporting life (not professional) * who were regularly exercising for sedentary group; * between 17-25 years ages * who had sedentary life style exclusion criteria: for boths group; * individuals who had surgical stabilization, * who had previous shoulder complex fractures * who had positive impingement test results * who had systemic diseases * who had neurological and orthopedic problems

Keywords: scapular muscle endurance shoulder pain regular exercising exercising
simultaneously pet/mri in prolonged doc patients

Conditions: Disorder of Consciousness; Minimally Conscious State; FDG-PET; Rs-fMRI

Summary: recently introduced hybrid pet/mr scanners provide the opportunity to measure simultaneously, and in direct spatial correspondence, both metabolic demand and functional activity of the brain, hence capturing complementary information on the brain's physiological state. here we exploited pet/mr simultaneous imaging to explore the relationship between the metabolic information provided by resting-state fluorodeoxyglucose-pet (fdg-pet) and fmri (rs-fmri) in patients with disorders of consciousness.


Eligibility criteria:
inclusion criteria: * doc patients （acute, subacute or chronic period）: coma, uws and mcs. exclusion criteria: * neuromuscular blocking agents or sedative drugs administered within the prior 24 hours； * unstable medical condition； * mental implant in the brain

Keywords: disorder of consciousness unresponsive wakefulness syndrome multimodal neuroimaging
effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty

Conditions: Oral Melatonin; Lidocaine Infusion; Postoperative Delirium; Elderly Patients; Total Hip Arthroplasty

Summary: the aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.

delirium is defined according to the american psychiatric association's fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5), as disturbance in attention and awareness developed over a short period of time , its severity tends to fluctuate during the course of a day, these disturbances cannot be better explained by other pre-existing neurocognitive disorders and do not occur in severely reduced arousal level such as coma. delirium can be further classified into hyperactive, hypoactive and mixed.postoperative delirium (pod) usually occurs in the recovery room and appears up to 5 days after surgery. the prevalence of pod in elderly patients undergoing surgery varies from 20% to 45%. patients undergoing hip fracture surgery are at higher risk of pod than patients undergoing other types of surgery. this may be related to their older age, higher incidence of comorbidities, and greater physical weakness. melatonin (n-acetyl-5-methoxytryptamine) is a neurohormone that is discharged by the pineal gland produced from the amino acid tryptophan. synthetic melatonin has been effectively utilized in the treatment of sleep disorders. it was likewise utilized as a premedication and it provided excellent anxiolysis, sedation, and sympatholytic impacts with the merit of not influencing the patients' cognition in addition to its analgesic effect. lidocaine, an amide local anesthetic and class-1 antiarrhythmic with sedative and anti-inflammatory properties, is increasingly used as a part of a multimodal intraoperative anesthetic adjunct in a variety of surgical procedures.

Eligibility criteria:
inclusion criteria: * elderly patients aged \>65 years old undergoing unilateral total hip arthroplasty. * patients with body mass index (bmi) (18-30) kg/m2. * american society of anesthesiologists (asa) physical status i-iii, scheduled to undergo unilateral total hip arthroplasty. exclusion criteria: * history of mental illness or scoring less than 8 using abbreviated mental test (amt) before operation. * obvious sinus bradycardia (heart rate of \<50 beats per minute) or other serious cardiovascular diseases. * symptomatic cerebrovascular disease (such as previous stroke). * history of liver and kidney dysfunction. * allergy to lidocaine or melatonin. * metabolic disorders and fluid, electrolytes disturbances. * alcohol dependence or drug abuse. * redo surgery or infectious complications. * cns medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants). * history of deep vein thrombosis.