Kornimate/medical-research-clean huggingface dataset:
cardioprotective effects of glp-1 and their mechanisms

Conditions: Angina Pectoris

Summary: ischaemic heart disease is the most common cause of death in the uk. glucagon-like peptide-1 (glp-1) has been demonstrated to protect the heart when it is deprived of blood supply (ischaemia). the mechanism for this protection is not clear. similar protection occurs with ischaemic conditioning of the heart, which is dependent on potassium channel opening. the investigators intend to establish whether glp-1 mediated protection shares a similar mechanistic pathway. in order to do this the investigators will measures pressure--volume loops generated in the main pumping chamber of the heart at the time of a percutaneous coronary intervention (stenting). patients will be allocated to glp-1 alone, glp-1 with glibenclamide (a potassium channel blocking medication approved for human use), saline control or glibenclamide alone. the investigators hypothesis is that the effect of glp-1 will be abrogated by use of glibenclamide.


Eligibility criteria:
inclusion criteria: * age over 18 * able to give informed consent * elective percutaneous intervention for a single vessel coronary stenosis * normal left ventricular function exclusion criteria: * severe co-morbidity * type 2 diabetes mellitus * nicorandil, sulphonylureas, dpp4 inhibitors, glp-1 agonists or insulin use * women of child bearing age * myocardial infarction in previous three months * previous coronary artery bypass grafts

Keywords: glucagon-like peptide 1 angina pectoris percutaneous coronary intervention ischemic preconditioning myocardial reperfusion injury
ultra - brief crisis ipt-a based intervention for suicidal children and adolescents (ipt-a-sci)

Conditions: Suicide, Attempted

Summary: to address the critical need in crisis intervention for children and adolescents at suicidal risk the investigators developed an ultra-brief acute crisis intervention, based on interpersonal psychotherapy (ipt). the current adaptation of ipt-a is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.

in recent years, suicidal behaviors have shown substantial increase worldwide. this trend is also prominent in israel and has led to a dramatic increase in mental health treatment demand resulting in long wait times and low treatment acceptance rate. to address the critical need in crisis intervention for children and adolescents at suicidal risk, the investigators developed an ultra-brief acute crisis intervention, based on interpersonal psychotherapy (ipt). ipt is an evidence-based intervention for various psychopathologies among different age groups. the current adaptation of ipt-a is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.

Eligibility criteria:
inclusion criteria: * depression symptoms * suicidal behavior exclusion criteria: * acute medical condition * intellectual disability * cognitive impairment * linguistic limitation
genetic determinants of the bronchodilatation effect of albuterol ex-vivo

Conditions: Asthma

Summary: the role played by ß2ar polymorphisms in determining the bronchial response to ß2ar agonist drugs, has been confirmed by several studies. the purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2ar and drug responsiveness. an ex-vivo model (organ bath technique) will be used to investigate association between polymorphisms in the coding region of ß2ar and the response of bronchial rings derived from human lung tissue to the respective agonists (i.e. salbutamol). in the second part of the study the same bronchial rings will be incubated for 24 hours in a solution containing fixed concentration of albuterol. a second dose response curve for rising concentrations of albuterol will be constructed and a relationship between β2 genetic polymorphisms and the extent of desensitization to albuterol will be investigated. in addition, through specifically designed receptor binding assay the bronchial tissue will be used to define the affinity (kd) and expression (vmax) of the ß2 receptor. these data will enable to enhance our understanding regarding the mechanism responsible for the association noted between ß2ar polymorphism and altered drug effect.


Eligibility criteria:
inclusion criteria: * macroscopically normal pulmonary tissue exclusion criteria: * the presence of pathological finding in the pulmonary tissue
transcranial direct current stimulation (tdcs) as a tool for prospective responder identification before vagus nerve stimulation (vns) implantation

Conditions: Epilepsy

Summary: the aim of the study is to establish tdcs as a prognostic tool to predict vns therapy outcome among patients with pharmacoresistant epilepsy.

in recent years it has been shown that many different brain stimulation techniques are effective in seizure reduction in epilepsy patients as well as in animal models of epilepsy. vns is the method most often used with at least 45.000 patients implanted with this device worldwide. however, prediction of seizure outcome after vns implantation is not possible in an individual patient so far. recently, tdcs is increasingly used as a method to reduce seizure frequency in epileptic patients. therefore it is hypothesized, that a positive effect after a single tdcs, in terms of short time seizure reduction and reduction of epileptic discharges in the eeg, could be predictive for epilepsy outcome after vns implantation. in the proposed multicenter prognostic study we test the predictive value of tdcs for each patient with refractory epilepsy 1 week up to 2 months before vns implantation. the effects of tdcs will be verified via a 15 minutes long routine eeg examination, performed immediately before and after tdcs, together with seizure diary and seizure severity scale, assessed 1 month before and 1 week after tdcs. a 6 months long observation period will follow the vns implantation. at the end of the 6 months period seizure diary and seizure severity scale of the last month will be performed to measure vns therapy outcome. on the basis of the described variables, immediate up to 1 week long tdcs effects will be correlated to 6 months long vns therapy outcome.

Eligibility criteria:
inclusion criteria: * age: 12 years and above * at least 2 years disease history * refractory epilepsy: * seizures are not completely responsive to longlasting antiepileptic treatment. at least 4 antiepileptic medicaments failed in mono or combined anticonvulsive regimen. * at least 4 seizures per week in the last month, despite adequate antiepileptic regimen. * epilepsy surgery is not indicated or not accepted by the patient or by the parents of the patient. * a stable anticonvulsive regimen, defined as unchanged dose and type of the antiepileptic medication in the last month before tdcs and before vns implantation. * seizure diary is available and completed. * vns implantation is planned within the next 2 months. exclusion criteria: * acute, symptomatic seizures (caused by tumor, stroke, acute encephalitis) * uncontrolled medical problems (e.g. cardiovascular, nephrotic oder severe, chronic or severe acute disease) * increased intracranial pressure for whatever reason * implantation of metallic material (e.g. pacemaker, cochlear-implant) * diseased or damaged skin over the scalp (e.g. dermatitis) * pregnancy * known or supposed non-compliance * age: less than 12 years

Keywords: electroencephalography seizure frequency seizure severity
use of sb-705498 in the acute treatment of migraine

Conditions: Migraine, Acute

Summary: despite the success of the triptan class of drugs, approximately 60% of patients who take medication at the moderate to severe pain stage of acute migraine, still have pain of mild or greater degree at 2 hrs post dose. sb-705498 is a novel, first in class trpv1 receptor antagonist under development for the treatment of migraine pain. preclinical experiments have demonstrated that the trpv1 receptor is expressed both centrally and peripherally in the trigeminal system and inhibition of trpv1 with sb-705498 can both prevent and reverse established central sensitisation.


Eligibility criteria:
inclusion criteria: * healthy subjects suffering from moderate to severe migraine headache with or without aura. * women of child bearing potential must use an effective method of contraception. * have had at least a 1 year history of migraine and the age of onset was prior to 50 years. * suffering 1 to 6 migraine attacks per month for at least the last 3 months and should have at least 48 hours free of headache between migraine attacks. exclusion criteria: * headache for 15 days/month or greater in any of the three months (90 days) preceding entry into the study. * use of migraine medications (e.g., ergotamine, triptan, opioid, or combination medication) on \>/= 10 days per month on a regular basis for \>/= 3 months. * use of analgesics \>/=15 days per month for \>/=3 months, uses an opiate (except codeine) as first line treatment for migraine. * migraine symptoms do not respond to any of the triptan drugs (e.g., imitrex, relpax, maxalt). * have uncontrolled hypertension or a history/ presence of multiple cardiovascular risk factors such as, but not limited to family history, myocardial infarction, coronary artery disease, vasospastic angina, heart failure, cardiac arrhythmias or history or presence of cerebrovascular disease, including transient ischemic attack, stroke or peripheral arterial disease. * history of alcohol, substance or drug abuse within the last year. * participation in a trial with a new chemical entity within 3 months before the start of the study. * participation in any other research trial within 30 days prior to the first dose of current study medication is not permitted.

Keywords: sb-705498 acute migraine single dose trpv1 combination inpatient outpatient study
olodaterol bridging study in asthma

Conditions: Asthma

Summary: the aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (fdc) with bi 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (ais).


Eligibility criteria:
inclusion criteria: 1. informed consent form consistent guidelines and local legislation prior 2. male or female patients aged at least 18 to 75 years. 3. diagnosis of asthma according to the 2009 global initiative for asthma (gina) guidelines. 4. maintenance treatment with a low or medium dose of inhaled corticosteroids (ics) with or without long-acting beta-adrenergic (laba), stable dose of inhaled corticosteroids (alone or in a fixed combination with a laba) for at least for 6 weeks prior to screening. 5. asthma control questionaire (acq)-6 mean score of \< 1.5. 6. a. pre-bronchodilator clinic measured fev1 =50% and =90% of predicted normal b. fev1 reversibility: improvement in fev1 =12% above baseline and an absolute change of at least 200 ml within 15-30 minutes after administration of 400 µg salbutamol. 7. never-smokers or ex-smokers with a smoking history of less than 10 pack-years and smoking cessation at least one year prior to screening. 8. be able to use the inhalers correctly in the opinion of the investigator. 9. be able to perform all trial related procedures. exclusion criteria: 1. significant disease other than asthma. 2. recent history (i.e. six months or less) of myocardial infarction. 3. hospitalisation for cardiac failure during the past year. 4. unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year. 5. lung diseases other than asthma (e.g. chronic obstructive pulmonary disease). 6. active tuberculosis. 7. malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. 8. thoracotomy with pulmonary resection. 9. alcohol or drug abuse within the past two years. 10. pulmonary rehabilitation program 11. hypersensitivity to laba drugs, ciclesonide, salmeterol or any other components of the study medication delivery systems. 12. pregnant or nursing woman. 13. women of childbearing potential not using a highly effective method of birth control.
evaluation of capillary blood collection devices (mitra® and hemapen®)

Conditions: Phenylketonuria; Metabolic Diseases

Summary: the aim is to demonstrate a new application for a blood collection device. this device is already widely used in pharmacology. it is not currently used for metabolic diseases. its ease of use enables repeated sampling at home. what's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.


Eligibility criteria:
inclusion criteria: * children aged 3 months to 18 years * suffering from phenylketonuria or hyperphenylalaninemia * who have had a capillary and blood test including a phenylalanine assay at chuga * whose parents or legal guardians are affiliated to the social security system. * for whom parents or legal guardians have not objected to the mitralanine study. exclusion criteria: * parents or legal guardians opposed to the mitralanine study
efficacy and safety study of bf2.649 in the treatment of excessive daytime sleepiness in narcolepsy

Conditions: Narcolepsy; Excessive Daytime Sleepiness; Cataplexy; Sleep Disorders

Summary: the objective of this study is to evaluate the efficacy and safety of bf2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (eds)

bf 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (eds) evaluated by epworth sleepiness scale (ess), according the results of two previous clinical studies. the objective of this study is to determine the efficacy and safety of bf2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and modafinil as assessed by both of objective and subjective measures including ess, mwt, patients sleep diary. 60 patients with narcolepsy with or without cataplexy will be included.

Eligibility criteria:
inclusion criteria: * diagnosis of narcolepsy with or without cataplexy * patients need to free of or discontinue psychostimulant medications for at least 14 days, * patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses * patients must have adequate support to comply with the entire study requirements exclusion criteria: * other conditions than narcolepsy that can be considered as the primary causes of excessive daytime sleepiness * patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances * psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation * current or recent history of a substance abuse or dependence disorder including alcohol abuse

Keywords: narcolepsy excessive daytime sleepiness cataplexy sleep disorders sleep attacks orphan drug pitolisant
study to evaluate the pk of single and optional multiple dosing regimens of mr formulations of pcs499 compared to trental® administered to healthy subjects

Conditions: Healthy

Summary: this was a phase i, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. the purpose of part 1 was to identify a mr formulation of pcs499 that would provide an optimal dosing regimen in patients. the purpose of part 2 of the study was to generate repeat dose information for the selected mr formulation of pcs499 in order to provide additional pk information for future patient studies.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-lactating female subjects 2. aged 18 to 55 years, inclusive 3. subjects who were healthy as determined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs, 12-lead resting electrocardiogram (ecg; corrected qt interval \[qtc\] ≤450, qrs \<120, pr \<220; normal morphology) performed at the screening visit and prior to each dosing 4. body mass index (bmi) of 18.0 to 35.0 kg/m2 inclusive or, if outside the range, considered not clinically significant by the investigator and body weight \>50 kg 5. subjects who were willing and able to be confined at the clinical research centre for the scheduled inpatient visits 6. ability to swallow multiple tablets whole exclusion criteria: 1. subject had a clinically significant history of gi, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders and/or drug hypersensitivity 2. subject had a known or suspected malignancy with the exception of basal cell carcinoma 3. subject had a positive blood screen for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus antibody (hcv ab) at the screening visit 4. female subjects who were pregnant or lactating (all female subjects required a negative serum pregnancy test at the screening and a negative urine pregnancy test at each admission). 5. subject had active disease or symptoms within 7 days prior to day -1, such as nausea, vomiting, diarrhoea, and infection 6. subject had undergone a hospital admission or major surgery within 30 days prior to the screening visit 7. subjects who had taken part in part 1 were not permitted to take part in part 2
acute effects of endurance exercise on breast milk composition in women with overweight/obesity

Conditions: Breast Milk Collection; Overweight and Obesity

Summary: the investigators will determine the acute effect of exercise on breastmilk composition. participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. the conditions will be randomly allocated to each participant. breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. dietary intake will be standardized on the test days.


Eligibility criteria:
inclusion criteria: * 6 weeks postpartum * exclusively breastfeeding * term birth * singleton baby exclusion criteria: * known cardiovascular disease * known type 1 or type 2 diabetes * limited ability to exercise

Keywords: exercise
application of probiotic ps128 in children with asd

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to explore the role of probiotics ps128 in improving gastrointestinal dysfunction and core behavioral symptoms in children with asd, and investigate the underlying etiological mechanisms of asd.

after being informed about the study and potential risks, all patients giving written informed consent will undergo screening period to determine eligibility for study entry. participants who meet the eligibility requirements will be randomized in a double-blind manner(participant and investigator) in a 1:1 ratio to probiotics ps128 group or placebo group. each patient acts as his or her own control, and they receive both the study drug as well as the placebo. after a washout period, the participants will be switched throughout to different treatments（probiotics placebo group or ps128 group）.

Eligibility criteria:
inclusion criteria: 1. children aged 2-5 years with asd from tongji hospital (both boys and girls); 2. meets diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) and ados-2 diagnostic criteria; 3. no significant abnormalities on head mri or eeg; 4. if psychotropic medication is required during the project, the psychiatrist must confirm that medication is stable during this period (no change in dose or type of medication); 5. willing to provide samples such as blood, urine and feces. exclusion criteria: 1. take antibiotics or antifungal drugs within 15 days prior to the project. 2. take probiotic products within 30 days prior to the project. 3. have acute diarrhea within 30 days prior to the project. 4. start taking new psychotropic medication within 15 days prior to the project. 5. have severe hearing, visual or motor impairment. 6. accompany with other mental behavioral disorders, such as schizophrenia, bipolar disorder. 7. a history of rett syndrome, chromosomal, inherited metabolic disorders and other significant somatic disorders. 8. a history of organic gastrointestinal disorders (e.g., gastroesophageal reflux, food allergies, inflammatory bowel disease), history of intestinal surgery, intestinal obstruction, intestinal perforation, intestinal bleeding, multi-organ failure, and severe immunodeficiency disorders 9. have a special diet (e.g., gluten-free diet, casein-free diet, ketogenic diet, etc.) 10. co-morbidities in children with asd were documented and discussed in detail by two or more behavioral developmental behaviorists, and children with asd who required immediate rehabilitation or neurological analogs for co-morbidities were not allowed to enter this study.

Keywords: asd probiotics
clinical trial to evaluate the efficacy, tolerance and acceptability of urgo dressing vs a hydrofibre in the local management of venous or predominantly venous mixed leg ulcers.

Conditions: Varicose Ulcer

Summary: the main objective of this trial is to demonstrate that a local care strategy using urgo 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. this non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.


Eligibility criteria:
inclusion criteria: * patient over 18 years old who has provided his/her written informed consent * patient who can be monitored by the same investigation team throughout the duration of the study * patient who agrees to wear effective venous compression every day, associated with the trial dressing * leg ulcer with a distal ankle brachial pressure index (abpi) not less than 0.7 and not more than 1.3 * ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2 * ulcer duration between 3 and 36 months * ulcer where the surface area is 70% or more covered by fibrinous tissue * ulcer at least 3 cm away from any other lesion * ulcer moderately or strongly exudative justifying the use of an absorbent dressing exclusion criteria: * female patient of child-bearing potential who has no effective means of contraception * patient who is pregnant or breastfeeding * patient taking part in another therapeutic trial * patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid) * patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment * patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy * patient with a systemic infection not controlled by suitable antibiotic treatment * patient who, during the 3 months before inclusion, presented a deep vein thrombosis * ulcer where its surface is totally or partially covered by black necrotic plaque * ulcer which is clinically infected * ulcer requiring surgical treatment or for which surgery is programmed during the six weeks following inclusion * malignant ulcer