Kornimate/medical-research-clean huggingface dataset:
the effect of linagliptin (bi 1356) on 24h-glucose control and various biomarkers in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this study is to investigate the effect of bi 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.


Eligibility criteria:
inclusion criteria: * male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with not more than one drug * glycosylated haemoglobin a1 (hba1c) 6.5 to 10.0% at start of run-in exclusion criteria: * myocardial infarction, stroke or transient ischemic attack "tia" within 6 months prior to informed consent * impaired hepatic function * renal insufficiency with a creatinine clearance \< 50 ml/min * treatment with rosiglitazone, pioglitazone, glucagon like peptide 1 (glp-1) analogues, insulin, dipeptidyl peptidase 4 (dpp-4) inhibitors or anti-obesity drugs 3 months prior to informed consent.
lurasidone hcl - a 6-week phase 3 study of patients with acute schizophrenia.

Conditions: Schizophrenia

Summary: lurasidone hcl is a compound being developed for the treatment of schizophrenia. this clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine xr short term among acutely psychotic patients with chronic schizophrenia.


Eligibility criteria:
inclusion criteria: * provide written informed consent and aged between 18 and 75 years of age. * meets dsm-iv™ criteria for a primary diagnosis of schizophrenia. * not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study. * able and agrees to remain off prior antipsychotic medication for the duration of study. * good physical health on the basis of medical history, physical examination, and laboratory screening. * willing and able to comply with the protocol, including the inpatient requirements and outpatient visits. exclusion criteria: * considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. * any chronic organic disease of the cns (other than schizophrenia). * used investigational compound within 30 days. * clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

Keywords: schizophrenia sm-13496 latuda lurasidone
rtms for the treatment of freezing of gait in parkinson's disease

Conditions: Parkinson's Disease

Summary: this study is a double blind comparative study examining the effectiveness of the rtms treatment on freezing of gait (fog) in patients with parkinson's disease (pd). the investigators hypothesize that treatment with rtms on supplemental motor area will improve gait quality and decrease the frequency of fog in pd patients.

freezing of gait (fog) is a common and debilitating symptom in patients with parkinson's disease (pd), characterized by sudden and brief episodes of inability to produce effective forward stepping. fog is a major risk factor for falls, and greatly contributes to reduced mobility and quality of daily life. treatment of fog has been perceived as a very challenging task. although various treatment approaches exist, including pharmacological and surgical options, evidence is inconclusive for many approaches and no clear treatment protocols are available until now. repetitive transcranial magnetic stimulation (rtms), a noninvasive neural modulation technique, has been closely applied as a treatment for various neurologic and psychiatric disorders. a recent meta-analysis demonstrated that rtms could improve motor symptoms for pd patients with a moderate effect size. to date, however, only few rtms studies have focused on its efficacy on fog in patients with parkinsonism, and most of them targeted the primary motor cortex or dorsolateral prefrontal cortex . even though some evidence indicates the involvement of the sma in fog, no report has described the sma rtms in pd patients with fog. moreover, few studies combined functional magnetic resonance imaging (fmri) and rtms to unravel the mechanism of its beneficial effects. to address these issues, the investigators conducted a randomized, double-blind, sham-controlled study to explore the efficiency of sma-rtms on fog in pd patients.

Eligibility criteria:
inclusion criteria: * idiopathic pd patients. * presenting with fog. * the mini-mental state examination questionnaire score above 24 points. exclusion criteria: * other neurological or psychiatric disorders. * history of epilepsy, seizures or convulsions. * metal implantation. * history of exposure to rtms in the past (to minimizing risk of unblinding sham condition).

Keywords: freezing of gait rtms fmri
phase iii trial of febuxostat in korea gout patients

Conditions: Gout

Summary: this study was designed to evalute the efficacy and safety of febuxostat after oral administration to patientd with gout in korea

this is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration. if subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. colchicine 0.6mg qdis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.

Eligibility criteria:
inclusion criteria: \ 1. age :18-85 years 2. female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception 3. female: negative serum pregnancy test 4. subjects who satisfy ara (american rheumatism association) 5. subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dl \ 1.serum urate level ≥8.0mg/dl 2.creatinine level ≤ 1.5mg/dl 3.subject continued to meet all inclusion and no exclusion criteria exclusion criteria: 1. women who are breast-feeding or pregnant 2. a history of xanthinuria 3. allopurinol intolerance 4. receiving thiazide diuretic therapy 5. secondary hyperuricemia 6. required \> 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed. 7. concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day). 8. any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit 9. alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited. 10. concomitant therapy with any urate-lowering therapy 11. active liver disease or hepatic dysfunction : alt, ast ≥1.5 uln 12. subject was unable to take colchicine or contradictory to colchicine 13. a serum urate level \< 8.0mg/dl and not taking uric acid lowering therapy 14. rheumatoid arthritis or any active arthritis requiring for the medication treatment 15. a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit 16. participated in another investigational trial within the 30days prior to the screening visit 17. any other significant medical condition as defined by the investigator
microbiome and metabolomics profiling in children with osa

Conditions: Obstructive Sleep Apnea

Summary: objectives: obstructive sleep apnoea (osa) exhibits variable susceptibility to end-organ morbidities. previous studies suggest that physiological sequelae in individuals with osa promote changes in microbiome, which also interact with metabolic and inflammatory mediators. therefore, microbiome and metabolomic profiling could potentially reveal the pathological processes underlying osa. the primary objectives of our study are 1)to investigate the differences in the composition of nasal and stool microbiome between children with osa and non-osa controls; 2)to investigate the differences in the urine metabolomic profiles between children with osa and non-osa controls. hypothesis to be tested: the microbiome composition and urine metabolomic profiles are different between children with osa and non-osa controls. changes in microbiome composition are associated with specific urine metabolomic and inflammatory profiles in children with osa. design and subjects: a prospective case-control study. chinese children aged 6-11 years old with habitual snoring and polysomnography (psg) confirmed osa will be recruited as cases. non-osa healthy children will be recruited as controls. all subjects will undergo evaluation including questionnaires, anthropometric measurements, psg, blood, urine, nasal and stool sampling. primary outcome measures: microbiome and metabolomic profiles in children with osa compared to non-osa controls. analysis: comparisons of the microbiome and metabolomic profiles between osa children and controls. correlations of microbiome and metabolomic profiles with inflammatory biomarkers and psg measurements will be evaluated by regression analysis. expected results: this study will provide novel data regarding microbiome and metabolomic profiles, and their relationship with inflammatory biomarkers in children with osa.


Eligibility criteria:
inclusion criteria: * children aged 6-11 years old exclusion criteria: * previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, suspected or confirmed congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities, structural or congenital heart disease, use of medications or therapy that could affect immunity such as systemic corticosteroids, chemotherapy, radiation therapy, intravenous immunoglobulins.
use of metabolomics to differentiate the antihypertensive effect of acupuncture from sham acupuncture in hypertensives

Conditions: Hypertension,Essential

Summary: to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

acupuncture has been widely used for blood pressure management. its effect on the cardiovascular-related targeted metabolome is still unknown. this pilot study aimed to assess the effect of acupuncture versus sham acupuncture on regulating the targeted metabolome of hypertensive patients.

Eligibility criteria:
inclusion criteria: * aged between 45 and 75 years; * were diagnosed as stage i hypertension in the first visit, or used to be diagnosed with stage i hypertension in recent 1 year, but without any medication history; * without neurological, other cardiovascular, hepatic and renal disease, and other visceral diseases; * the basal metabolism rate of a patient, which was measured by the retrospective dietary questionnaire at baseline, should be approximately 1:1.4; * didn't administer any drugs or herbs in at 15 days before the start of the study; * didn't participate in any study other than this; * agreed to cooperate with researchers in all research procedures after they were introduced this study; and * provided with written informed consent. exclusion criteria: * age≤45 or age≥75; * with hypertension which was secondary to other diseases, such as renal vascular disease, cushing's syndrome, hyperadrenocorticism and drug-induced hypertension; * had complicated cardiovascular, digestive, respiratory, urinary, blood, nervous, endocrine system and other severe primary diseases and failed to effectively control in clinic; * accompanied by epilepsy, sleep apnea, hypopnea syndrome, etc.; * with psychiatric symptoms such as severe depression or anxiety (sas≥70, or sds≥72); * pregnant or lactating woman, or woman of reproductive age who was intended to conceive in recent 1 year; * with abnormality in laboratory test of blood biochemistry, or with contagious risks, such as hiv virus carrier, or patient with positive hepatitis b virus (hbv) superficial antigen; * with malignant tumor or other severe consuming diseases, or patients with infections or bleeding disorders; * alcoholics or drug abusers, or vegetarians; * used to suffer from acute diseases in recent 2 weeks, such as high fever, or gastritis; * used to administer any drug that may potentially impaired renal or hepatic function; * with cardiovascular disease that had been treated with acupuncture within recent three months; or * undergoing other clinical trials.

Keywords: acupuncture hypertension targeted metabolome pilot clinical trial
febrile infants - diagnostic assessment and outcome

Conditions: Meningitis, Bacterial; Bacterial Infections; Urinary Tract Infections

Summary: the purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the emergency department. the measurable outcomes are: primary objective report the rates of serious and invasive bacterial infections in febrile infants secondary objectives report on the predictive value of different clinical features for predicting bacterial infections. report on the value of biomarkers for predicting serious and invasive bacterial infections. assess the performance of clinical practice guidelines for the assessment of febrile infants.

the assessment of febrile infants is difficult. in the uk and ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. approaches in the united states and europe including the pecarn and stepbystep approach allow for the discharge home of some low risk young infants. we intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. we also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.

Eligibility criteria:
inclusion criteria: * any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the emergency department.
assessment of knowledge on pneumococcal vaccination among diabetologists in india

Conditions: Pneumococcal Vaccine

Summary: asia has the highest burden with the largest contribution of pneumonia burden from india. pneumonia is also observed as 5th leading cause of deaths in india. people with diabetes with uncontrolled glucose are significantly at higher risk of development of pneumonia. even though, pneumonia is a vaccine-preventable disease, hospitalization for pneumonia of patients with diabetes are rising. very limited literature is available on the knowledge and practice of pneumonia vaccination among diabetologists and the rate of pneumonia vaccination received by the patients with diabetes. hence this study aims to assess their knowledge on the same. in addition, this study also aims to identify the real barriers and facilitators of pneumococcal vaccination among diabetologists in india. a cross-sectional study will be conducted among 25diabetologists in each of the four zones in india representing all directions - north, east, west and south. diabetologists will be selected through purposive sampling. a semi-structured questionnaire (study tool) is designed based on the existing literature that addresses our objectives. an education session on pneumococcal vaccination will be conducted for the diabetologists through webinar after completing the survey. a post assessment will be done using the same questionnaire among the study participants after the education session in order to see an increase in the knowledge of pneumococcal vaccination.


Eligibility criteria:
inclusion criteria: diabetologists willing to participate in the study exclusion criteria: unwillingness to give consent for participation
electrophysiological recordings of deep brain stimulation in the basal ganglia

Conditions: Parkinson Disease

Summary: the pathology of parkinson's disease (pd) and the mechanism of deep brain stimulation surgery (dbs) are not completely understood. the recording data that is used routinely as part of the procedure to map the target structures, however, may be analyzed in order to better understand the neural network dynamics in pd. the purpose of the study is to perform simultaneous neural recordings from sub-cortical structures (e.g. subthalamic nucleus \[stn\] or globus pallidus internus \[gpi\]) and the cerebral cortex. these simultaneous recordings may provide insight in the pathology of pd and the mechanism of dbs. the researchers will also study the effects of anesthesia level on neuron synchronization . recordings with micro-ecog grid electrodes in the cortex show improved spatial resolution and these will be used to gain better understanding of cortical network dynamics and the synchronization with subcortical structures.

subjects will be identified exclusively from the researchers' clinical practice for evaluation of dbs surgical candidacy for parkinson's disease. once it is determined that a patient is an appropriate candidate for dbs placement (multidisciplinary team consensus) and has met inclusion criteria,the researchers will discuss the study with the subject and explain the rationale for the study as well as the implications the subject's participation has to their treatment. informed consent will be obtained prior to study procedures being performed. subjects will be in the study from the time of enrollment before surgery until all post-operative visits and tests are completed, usually by 6 months after surgery. follow-up during this time will consist of the standard follow-up schedule that all patients who undergo dbs follow. this includes a clinic visit at 10-14 days, 12 weeks, and 6 months after dbs surgery. subjects will also have a follow-up neurocognitive evaluation consisting of the same evaluative tests administered pre-operatively. these post-operative visits are standard for all patients undergoing dbs for parkinson's.

Eligibility criteria:
inclusion criteria: * parkinson's disease per queens square criteria * appropriate dbs candidate for multi-disciplinary team consensus * age 18 - 85 years of age * motor skills allowing for capability to complete evaluations * medically cleared for undergoing anesthesia and dbs surgery exclusion criteria: * dementia per dsm-v criteria * medical or other condition precluding mri * history of supraspinal cns disease other than pd * alcohol use of more than 4 drinks per day * pregnancy * history of suicide attempt * currently uncontrolled clinically significant depression (bdi\>20) * history of schizophrenia, delusions, or currently uncontrolled visual hallucinations

Keywords: deep brain stimulation
amlodipine diabetic hypertension efficacy response trial

Conditions: Hypertension

Summary: to evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure goal of \<130/80 with amlodipine versus placebo in subjects initially treated with quinapril or losartan.


Eligibility criteria:
inclusion criteria: * documented evidence of type 2 diabetes as defined by the ada guidelines and documented evidence of hypertension (various sbp/dbp ranges). exclusion criteria: * a previous history or intolerance or hypersensitivity to calcium channel blockers, arbs or ace inhibitors.
study to compare efficacy and safety of tev-45779 with xolair (omalizumab) in adults with chronic idiopathic urticaria

Conditions: Chronic Urticaria

Summary: the purpose of the study is to compare the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of tev-45779 compared to xolair in patients with urticaria (ciu)/chronic spontaneous urticaria (csu) who remain symptomatic on h1 antihistamine treatment.

this is a multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of tev-45779 compared to xolair administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks (6 treatments) in patients with chronic idiopathic urticaria (ciu)/chronic spontaneous urticaria (csu) who remain symptomatic despite antihistamine (h1) treatment. this study will consist of a screening period (up to 2 weeks), a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period, which is followed by a 16-week follow-up period. the total duration of the study is up to 42 weeks. at baseline, patients will be randomized in a 2:2:1:1 ratio to receive the first 3 treatments of tev-45779 300 mg, xolair 300 mg, tev-45779 150 mg or xolair 150 mg (main treatment period). at week 12, prior to receiving their fourth dose of study medication, patients in the xolair 300 mg and the xolair 150 mg treatment groups will be randomized 1:1 to receive 3 additional doses of xolair (at the same dose level as prior to randomization, or switch to 3 doses of tev-45779 (transition period) at the same dose level as prior to randomization. all patients in the tev-45779 groups will continue to receive tev-45779 at the same dose levels.

Eligibility criteria:
inclusion criteria: * diagnosis of ciu refractory to h1 antihistamines for ≥3 months exclusion criteria: * chronic urticaria with clearly defined underlying etiology * other skin disease associated with itch * evidence of parasitic infection on stool evaluation for ova and parasites * history of anaphylactic shock * hypersensitivity to omalizumab or any component of the formulation * required background therapy with other than protocol-defined antihistamines * any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study
an observational study in type 2 diabetic patients on oral antidiabetic drugs and basal insulin in near east countries

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to investigate the safety and efficacy of insulin detemir as add-on therapy in type 2 diabetic patients who are using oral antidiabetic drugs.


Eligibility criteria:
inclusion criteria: * after the physician decision has been made to use insulin detemir therapy, any subject with type 2 diabetes who is treated with any one or more of the oral antidiabetic drug (metformin, su, repaglinide, tzds) is eligible for the study. the selection of the subjects will be at the discretion of the individual physician. particular attention should be paid to the drug interactions that are listed within the product label exclusion criteria: * subjects currently being treated with insulin detemir or any other insulin regimen including regular(bolus) insulin * subjects with a hypersensitivity to insulin detemir or to any of the excipients * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months. women of childbearing potential who are not using adequate contraceptive methods