Kornimate/medical-research-clean huggingface dataset:
comparison of single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and 70 in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to compare the single dose and steady state pharmacodynamics of biphasic insulin aspart 30 and biphasic insulin aspart 70 in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 12 months * currently on basal bolus treatment with soluble human insulin, lispro and nph insulin or lantus. nph insulin may be administered once or twice daily * bmi (body mass index) maximum 35 kg/m\^2 * able and willing to perform self-blood glucose monitoring exclusion criteria: * the receipt of any investigational drug within the last 30 days prior to this trial * total daily insulin dose at least 1.8 u/kg/day * currently being treated with insulin aspart products * a history of drug abuse or alcohol dependence within the last 5 years * impaired hepatic function * impaired renal function * blood donation (exceeding 500 ml) within the last nine weeks or haemoglobin below the lower reference limit according to the local laboratory * cardiac problems * severe, uncontrolled hypertension
effect of 4 weeks fish oil supplementation on cycling performance in healthy male cyclists

Conditions: Exercise-induced Inflammation

Summary: research plan eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout between supplementation periods. during the performance trials blood, expired air and heart rate were collected. the blood samples have been used to investigate the production of inflammation resulting from the cycling performance test. inflammation has been assessed using enzyme-linked immunosorbent assay for il-6, which is an inflammatory cytokine. work done from the cycling performance will be analysed to investigate whether there is a relationship with power and inflammation and whether this is modulated by fish oil supplementation. specific aims 1. does 4 weeks of fish oil supplementation attenuate the inflammatory response following high intensity cycling. 2. is a modulation of the inflammatory response connected to cycling performance. hypotheses 1. four weeks of n3-pufa supplementation will reduce the inflammatory response 2. a reduction in inflammation will improve cycling performance anticipated outcomes a high level of cycling performance, indicated by a high average power, will be associated with high levels of systemic inflammation. n3-pufa supplementation will decrease the level of inflammation and consequently cycling performance will be improved.


Eligibility criteria:
inclusion criteria: * recreationally trained male cyclists exclusion criteria: * history of coagulation/bleeding disorder * history of metabolic disease * serious allergy * history of heart disease * regular use of anti-inflammatory drugs * vitamin or fish oil supplementation over the past 6 months * known to have blood-borne virus * females

Keywords: exercise fish oil cycling inflammation oxidative stress
evaluation of sglt2-i effectivness and safety in elderly type 2 diabetes patients

Conditions: Type2Diabetes

Summary: the aim of the study is to evaluate the benefits, documented in experimental settings, of treatment with sglt2-i in subjects with type 2 diabetes and older than 70 years in normal clinical practice. the type of study does not involve immediate risks or direct benefits for the subjects taking part in it. the potential benefits for clinicians and healthcare systems are: greater knowledge of diabetic disease and the study of new treatment options. however, the analysis of the data will allow us to better identify which patients benefit most from treatment with glycosurics.

sodium-glucose co-transporter-2 inhibitors (sglt2i) may have important benefits for the elderly with type 2 diabetes (t2d), however some safety concerns still limit their use in patients over 70 years of age. the sold study (sglt2-i in older diabetic patients) aim to evaluate which basal characteristics of the patients are more frequently related to the suspension of treatment with sglt2-i in a real-life setting.

Eligibility criteria:
inclusion criteria: * informed consent issued before any other activity related to the study (i.e. any activity related to data collection according to the study protocol); * diagnosis of type ii diabetes mellitus, according to ada indications for at least 3 months * males or females \> 70 years old * stable therapy for at least 3 months with oral hypoglycemic agents / insulin * prescription of sglt2 inhibitors, in accordance with normal clinical practice and local drug prescription / reimbursement guidelines. exclusion criteria: * mental incapacity, unavailability or language barriers that preclude adequate understanding or cooperation; * diagnosis of type 1 diabetes mellitus, mody (maturity-onset diabetes of the young), lada (latent autoimmune diabetes in adults), gestational diabetes mellitus, secondary diabetes mellitus or any other hyperglycemic state other than t2d; * previous participation in the study. participation is defined by having given informed consent to the study; * participation in another clinical study on t2d that includes any clinical intervention or administration of an investigational drug within 3 months prior to enrollment in the study

Keywords: sglt2-inhibitors elderly safety
the effect of aerobic interval training on obstructive sleep apnea

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the purpose of this study is to investigate if 3 months of interval training improves obstructive sleep apnea in obese patients diagnosed with moderate to severe obstructive sleep apnea. the working hypothesis is that 3 months of 3 weekly aerobic interval training sessions improve obstructive sleep apnea and sleep quality in obese patients.

obstructive sleep apnea syndrome (osas) is characterized by repetitive obstruction and collapse of the upper airway resulting in successive episodes of cessation of or decreased respiratory airflow, causing oxygen desaturation, awakening, loud snoring and daytime sleepiness in patients. sleep apnea is frequently associated with co-morbidity such as obesity, diabetes, hypertension, the metabolic syndrome and cardiovascular disease. lack of exercise is associated with osas severity, independent of body mass. participation and motivation to exercise is low in osas patients, with less that one third of the patients reporting regular exercise routines. we aim to investigate if aerobic interval training improves osas in obese subjects.

Eligibility criteria:
inclusion criteria: * bmi ≥ 30 kg/m2 * apne - hypopnea index (ahi) \> 10 * no significant comorbidities * abel to exercise exclusion criteria: * inability to exercise due to musculoskeletal conditions * known ischemic cardiovascular disease * drug abuse * mental illnesses

Keywords: randomized controlled study exercise training lung function heart function
effect of cow's milk kefir on short chain fatty acid (scfa), haemoglobin, and ferritin levels of anemic adolescent girls

Conditions: Iron Deficiency Anemia

Summary: introduction: the prevalence of anemia among adolescent girls in indonesia is still quite high. according to the indonesian health survey (ihs) in 2023, it was 18% and is still a national problem. long-term supplementation of blood supplement tablets (ttd) as an effort made by the government to prevent/overcome anemia has caused side effects, namely dysbiosis by pathogenic bacteria. giving cow's milk kefir containing various probiotics can overcome the side effects of supplementation, and its metabolites accelerate iron absorption so that iron status in the blood increases and ultimately restores anemia in adolescent girls. method: it's research is an experimental study, with a randomized controlled trial (rct) design, pre-posttest design, involving research subjects of adolescent girls (15-18 years) with mild and moderate anemia, at smkn 1, 2, and 3 kasihan, bantul regency, yogyakarta as many as 80 students. subjects were divided into 2 groups, namely group 1 (treatment group), which was given 120 ml of cow's milk kefir every day and ttd 1 grain/week, and group 2 (control group), which was given 120 ml of cow's milk every day and ttd 1 grain/week. the duration of administration was 2 months. the study outcomes were short chain fatty acid (scfa) levels in feces by gas chromatography-mass spectrometry (gc-ms) method, hemoglobin by hematology analyser method, and serum ferritin by ferritin elisa measured at the beginning and end of the study. statistical analysis included univariate, bivariate, and multivariate analysis. clinical analysis was also conducted to estimate the effect size of the treatment

this protocol represents the only doctoral research dissertation proposal i will undertake as part of my dissertation, which does not exist.

Eligibility criteria:
inclusion criteria: * adolescent girls aged 15-18 years * have a mild and moderate degree of anemia (hb 8-11.9 g/dl) * have a normal menstrual cycle and duration exclusion criteria: * suffering from thalassemia, hemosiderosis, blood cancer, and malaria, based on the doctor's diagnosis in the last 3 months * taking supplements other than ttd * taking antibiotics in the last 3 months * suffering from lactose intolerance through interviews

Keywords: kefir short chain fatty acid hemoglobin ferritin iron deficiency anemia
study a - mk0767 monotherapy study

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to test if mk0767 lowers blood glucose after 20 weeks compared to placebo. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * non-pregnant females and patients who agree not to become pregnant during the study exclusion criteria: * patients with type 1 diabetes * patients who have been treated with insulin or other antihyperglycemic agents * patients with viral hepatitis, active liver or gallbladder disease, history of pancreatitis, heart disease, congestive heart failure, inadequately controlled hypertension, hiv positive, history hematologic disorders or neoplastic disease
treatment strategies for igg4-rd patients with internal organ involvement

Conditions: Autoimmune Diseases

Summary: this study has been designed as a 18-month, open-label randomized controlled clinical trial. the study aims to compare the efficacy and safety of two treatment strategies in active igg4-rd patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.

60 active igg4-rd patients with internal organ involvement are enrolled in this study and accept the combination treatment of glucocorticoids and mycophenolate mofetil in remission induction period (6 months), during which glucocorticoids are tapered regularly and discontinued in 6 months. during remission maintenance period, pateints are randomly divided into two groups at a 1:1 ratio: patients in group i are treated with low dose mycophenolate mofetil (1-1.5g/day) and patients in group ⅱ accept the treatment of leflunomide (20 mg/day). patients in two groups will be followed up for another 12 months, and clinical evaluations, laboratory tests, image examinations and igg4-rd responder index (ri) will be recorded during follow up. the primary endpoint is the difference of relapse rate between two groups at 18 months. the secondary endpoints are relapse time, response rate and side effects.

Eligibility criteria:
inclusion criteria: * 1. fulfillment of the 2019 american college of rheumatology/european league against rheumatology (acr/eular) igg4-related disease classification criteria; 2. newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment. exclusion criteria: * 1. patients who were diagnosed as other autoimmune diseases; 2. patients who were diagnosed as malignant diseases; 3. pregnant and lactating women； 4. active infection: hiv, hcv, hbv, tb； 5. severe irreversible damage of organ function; 6. receipt of any biologic therapy or immunosuppressive agent other than gcs.

Keywords: immunoglobulin g4-related disease treatment strategies relapse leflunomide mycophenolate mofetil
an efficacy and safety study of clemizole hcl in patients with lennox-gastaut syndrome

Conditions: Lennox Gastaut Syndrome

Summary: this is a multicenter, phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hcl (epx-100) as adjunctive therapy in children and adult participants with lennox-gastaut syndrome (lgs).

this is a multicenter, phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hcl as adjunctive therapy in children and adult participants with lgs. the study will consist of an observational period, a double-blind (db) period, and an optional open-label extension (ole) period.

Eligibility criteria:
key inclusion criteria: 1. males or females, ages ≥2 to ≤55 years, at the time of screening. 2. participant/parent/legal authorized representative (lar) willing and able to give written informed consent/assent. 3. diagnosis of lgs, including: * evidence of at least one type of countable major motor seizure. * history of electroencephalogram (eeg) consistent with lgs (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\<2.5 hz\], or 2) paroxysmal fast activity during sleep). * abnormal cognitive development. * onset of seizures at 11 years of age or younger. key exclusion criteria: 1. known sensitivity, allergy, or previous exposure to clemizole hcl. 2. known history of long qt syndrome or any significant history of a serious abnormality of the electrocardiogram (ecg) (e.g., recent myocardial infarction, clinically significant arrhythmia). 3. family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with qt prolongation in any family member. 4. seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control. 5. epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to screening. 6. concomitant use of fenfluramine. 7. prior or concomitant use of lorcaserin.

Keywords: lennox gastaut syndrome lennox-gastaut syndrome lgs clemizole hcl seizure
project impact: in-the-moment protection from automatic capture by trigger

Conditions: Substance Use Disorder

Summary: despite conscious intentions to remain abstinent, persons with substance use disorders often find that negative emotions and environmental cues automatically "trigger" drinking and other substance use. this study aims to test whether activating the baroreflex mechanism can be used "in the moment" to help resist drinking triggers. it consists of 3 phases (recruitment, intervention, follow-up). stage 1: trained research staff conduct a comprehensive clinical interview and questionnaires to assess participant's mood, substance use, and triggers. participants are paired with a primary research clinician (prc) who will work with them during the intervention. stage 2: approximately 4 weeks after intake into the center for great expectations intensive outpatient program, an 8-week intervention begins. pre-and post-intervention laboratory sessions occur at cardiac neuroscience laboratory, center of alcohol studies, piscataway, nj. some participants take part in pre- and post-intervention neuroimaging sessions (rutgers university brain imaging center, newark, nj). participants are randomized into an active intervention or control group after the pre-intervention lab session. they are given an iphone and trained to use a paced breathing app that is pre-loaded onto the phone. participants in both groups use their app any time they anticipate or experience a trigger to drink or use drugs. participants are compensated for their use of the app and the time for participation. to ensure that participants are correctly performing the paced breathing task, their prc visit with them weekly to provide coaching sessions using a computer-based biofeedback program. during the 4th week, ecg and respiration data are collected. participants also complete questionnaires about mood and triggers, and provide feedback on the usefulness of the app. during the lab sessions, participants complete a series of questionnaires and ecg, blood pressure and respiration are collected during four 5-minute tasks (resting baseline, non-resonance breathing, resonance breathing, and visual processing/attention). during the neuroimaging sessions, participants are placed in the scanner for structural scans and four 5-minute tasks (as tasks as previously noted); ecg and blood pressure are recorded. stage 3: participants are re-contacted 1 and 3 months after the intervention to complete questionnaires about their quality of life across multiple domains and the usefulness of the app.


Eligibility criteria:
inclusion criteria: * women over age 18 * women diagnosed with substance use disorder * women participating in iop at center for great expectations, new brunswick, nj exclusion criteria: * pregnancy

Keywords: baroreflex mechanism alcohol use disorder substance use disorder heart rate variability breathing
dynamic hyperinflation in mechanically ventilated chronic obstructive pulmonary disease patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: chronic obstructive pulmonary disease is a common respiratory condition that is characterized by inflammation of the large and small peripheral airways , the alveoli and adjacent capillary networks. severe airflow obstruction that imposes a significant load on the respiratory system is a major manifestation of chronic obstructive pulmonary disease. the reduced expiratory airflow also causes air trapping at the end of expiration , producing alveolar pressure that are higher than atmospheric pressure before the next breath. this condition is intrinsic positive end-expiratory pressure .


Eligibility criteria:
inclusion criteria: * patient with acute exacerbation of chronic obstructive pulmonary disease and respiratory failure who are intubated and mechanically ventilated. exclusion criteria: * patient with neuromuscular diseases. * patient with pulmonary vascular diseases e.g pulmonary embolism.
patients undergoing percutaneous coronary intervention (pci) through optimal platelet inhibition

Conditions: Percutaneous Coronary Intervention; Dual Antiplatelet Therapy; Aspirin; Clopidogrel

Summary: the purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-pci has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.

prospective multicenter registry. patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the verifynow p2y12 assay (accumetrics, inc., san diego, ca, usa). these will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-pci (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).

Eligibility criteria:
inclusion criteria: * the subject has provided informed written. * the subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment. * patient is established on chronic clopidogrel therapy when he/she returns for pci, and the components of dapt are determined by the clinical decision algorithm as local standard of care. * the subject is willing and able to cooperate with the study procedures and required follow-ups. exclusion criteria: * patients with cardiogenic shock will be excluded. * the subject is participating in an investigational device or drug study. subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study. * pregnant women.

Keywords: bleeding risk score outcomes prasugrel
non-invasive assessment of synaptic plasticity

Conditions: Movement Disorders; Parkinson Disease

Summary: the pathophysiological mechanisms underlying movement disorders, including parkinson's disease, have been related to altered synaptic plasticity affecting several structures of the central nervous system. although several previous neurophysiologic investigations have shown abnormal long-term potentiation and depression-like plasticity in m1, other regions crucially involved in motor planning and execution, including the spinal cord, have been studied less. parkinson's disease arises from the progressive loss of dendritic spines followed by atrophy of specific cortical (i.e. m1) and subcortical structures (i.e. putamen). these structural changes are responsible for the main clinical features of pd such as bradykinesia and rigidity. the present research project aims to probe non-invasively the main pathophysiologic mechanisms underlying altered synaptic plasticity in m1 and spinal cord and their relationship in a cohort of patients with movement disorders, including parkinson's disease. more in detail, the investigators will use specific methodologies able to induce plasticity, including the repetitive transcranial magnetic stimulation (tms), concerning the m1 and the focal muscle vibration, regarding the spinal cord. the neuromodulation protocol will imply 2 separate sessions, randomly scheduled to take into account the effect of the symptomatic pharmacologic treatment. furthermore, patients will be randomly assigned to sham or real non-invasive stimulation groups. before and after the stimulation protocol, the investigators will collect specific clinical as well as neurophysiologic measures (i.e., thresholds) according to standardized procedures. in conclusion, the goal of the study is to investigate the abnormal plasticity in the m1 and spinal cord in patients affected by specific movement disorders, through non-invasive techniques.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease exclusion criteria: * psychiatric disorders, including severe congnitive loss and depression