Kornimate/medical-research-clean huggingface dataset:
study of safety and efficacy of bcl201 and idelalisib in patients with fl and mcl

Conditions: Follicular Lymphoma, Mantle Cell Lymphoma

Summary: this is a phase ib multi-center, open-label study: escalation part followed by expansion part. the primary purpose of the phase ib cbcl201x2102c study is to characterize the safety and tolerability of bcl201 combined with idelalisib in patients with fl and mcl. approximately 65 patients are to be enrolled. the primary endpoint for the phase ib is frequency, severity and seriousness of aes, lab abnormalities and other safety parameters such as ecg changes. an adaptive bayesian logistic regression model (blrm) will guide the dose escalation to determine the mtd/rde in phase ib. in addition bayesian regression models will be used to estimate the dose-exposure relationships for both bcl201 and idelalisib in order to guide the escalation steps. a bayesian method for the expansion part will be used for the primary activity objective. the study data will be analyzed and reported based on all patients' data of the escalation and expansion part.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of fl or mcl according to who 2008 * relapsed or refractory with at least one (fl) or two (mcl), but not more than four, prior lines of antineoplastic regimens. * either fdg-avid on fdg-pet or measurable disease by ct on cross sectional imaging: \> 1.5 cm for nodal lesion, \> 1.0 cm for extra nodal lesion. * eastern cooperative oncology group (ecog) performance status of ≤ 2 exclusion criteria: * for dose escalation part: patients with mcl at high risk for tumor lysis syndrome * prior treatment with pi3kδ or bcl-2 inhibitors. * any other malignant disease * history of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis * inadequate organ function * concomitant treatment with: * strong cyp3a4/5 inducers or inhibitors * sensitive cyp3a4/5 substrates or cyp3a4/5 substrates with narrow therapeutic index (nti) * sensitive cyp2d6 substrates or cyp2d6 substrates with nti * selected dual substrates of cyp3a4/5 and cyp2c8 * selected dual substrates of cyp3a4/5 and cyp2d6 * selected dual substrates of oatp and cyp450 * selected dual substrates of cyp3a4/5 and p-gp * nti p-gp substrates * qt prolonging drugs with a known risk to induce tdp * proton pump inhibitors * treatment by warfarin or equivalent vitamin k antagonists. * other investigational therapies * herbal preparations/ medications * grapefruit, seville oranges or products containing either juice other protocol-defined inclusion/exclusion may apply.

Keywords: bcl201 idelalisib follicular lymphoma fl mantle cell lymphoma mcl
metformin versus vildagliptin in reducing risk of metabolic syndrome complications progression

Conditions: Metabolic Syndrome; Diabete Type 2; Kidney Insufficiency

Summary: several crosssectional and prospective studies have shown that metabolic syndrome and its related components are associated with both prevalent and incident ckd . although the mechanisms for these cardiovascular benefits of metformin and vildagliptin remain unclear, they extend well beyond glycemic lowering, and therefore are probably best considered diverse "cardiometabolic" pharmaceuticals rather than simply type 2 diabetes drugs. metformin and vildagliptin have known vasculoprotective actions, but the value of these drugs on drug-naïve diabetic patients during 24 week use warrants investigation. the investigator's purpose was to observe their effects on weight control, cardiometabolic risk factors, metabolic syndrome risk, and diabetic nephrooathy progression.

the current study is investigating the relation betweeneach componant of metabolic syndrome and kidney injury incidence or prevalence, and the mechanism of its occurence. the kidney protective effect of metformin and vildagliptin and the mechanism of this action whether it is related to their glucose lowering mechanism or not is also one of the important points to be investigated in the study

Eligibility criteria:
inclusion criteria: 1. men or women 40-70 years of age 2. body mass index be-tween≥22 and ≤40 kg/m2. 3. dm with an hba1c ≥ 7 exclusion criteria: (1) pregnant or nursing women; (2) chronic (\>7 consecutive days) oral, parenteral or intra-articular corticosteroid treatment within 8 weeks prior to visit 1 (3) history or evidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferase activities \> 2.5 times the upper limit of normal) (4) ischemic heart disease or cerebrovascular disease (5) creatinine level \> 0.133 mmol/l (6) major diabetes complications (chronic renal insufficiency, proliferative retinopathy and stroke); (7) extreme dyslipidemia, such as familial hypercholesterolaemia -

Keywords: metfomin vildagliptin metabolic syndrome t2dm nephropathy
the effects of different methods used in pediatric oral drug administration

Conditions: Children, Only; Fear

Summary: the aim of this study is to determine the effect of the use of spoons and oral injectors on the level of fear in children with fever in oral medication administration.

fever is known as a defense mechanism of the body; increased body temperature in children is one of the symptoms that frighten parents and is among the most common reasons for hospitalization. pharmacological agents such as paracetamol and ibuprofen are often used in fever management, and if possible, oral administration of the suspension form of the drugs is preferred to reduce invasive practices. however, reasons such as children not liking the taste of the medicine, rejecting the medicine, or spitting or vomiting may cause difficulties in administering the medicine orally. more than one different method is used to administer these drugs, depending on the patient's age, general condition and compliance with the treatment. these; they can be listed as spoon, oral injector, medicine glass. as a result of the examination of the drug administration materials, it was stated that children are fear of the injector when the drugs are given with a injector, they may aspirate, and they do not have appropriate equipment to administer the drug. it is important for nurses to understand children's fears and their causes, to develop interventions to reduce fear, and to minimize possible traumatic effects during the hospitilization process. in this study, the sample will be divided into two groups: experimental and control, and oral antipyretic medicine will be given by two different methods. an oral injector will be used in the experimental group and an oral medicine spoon will be used in the control group. hypotheses of the study: h0: there is no significant difference in the effect of the use of spoons and oral injectors in oral medication administration in children on the level of fear in children and parents. h1: there is a significant difference in the fear level of using spoons and oral injectors in oral medication administration in children. h2: there is a significant difference in the parents' fear level of using spoons and oral injectors in oral medication administration in children. h3: there is a significant difference in the heart rate and oxygen saturation of children using spoons and oral injectors for oral medication administration.

Eligibility criteria:
inclusion criteria: * children aged 3-6 and their parents, * children with fever, * children who have been ordered to take oral medication for fever in their treatment, * able to express himself cognitively, * able to speak and understand turkish exclusion criteria: * children who have a disease that may prevent them from expressing their fear * it is time for the child to sleep at the time of medication administration.

Keywords: oral medication administration fear children pediatric nursing
efficacy of bifeprunox in patients with schizophrenia

Conditions: Schizophrenia

Summary: the primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. there are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. in particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. in the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. the study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. after this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. in the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11916a).

Eligibility criteria:
inclusion criteria: main inclusion criteria * the subject has a primary diagnosis of schizophrenia * the subject experiences clinically significant symptoms * the subject's medication remained stable for 8 weeks prior to screening * the subject is currently in the post-acute maintenance phase of his/her disease exclusion criteria: main exclusion criteria * the subject is at significant risk of suicide * the subject is treatment resistant * the subject has experienced an acute exacerbation within 8 weeks prior screening * the subject is unlikely to comply with the protocol * the subject has a current diagnosis or a history of substance abuse

Keywords: schizophrenia antipsychotic bifeprunox
colon investigation - factors determining choice of procedure

Conditions: Irritable Colon; Colorectal Cancer; Inflammatory Bowel Disease

Summary: registration of patients referred for colon investigation by barium enema, ct colonography and colonoscopy in two hospitals and one radiology centre in telemark, norway, for a period of minimum six months. indications, delay and results of procedure will be recorded.hypothesis: choice of procedure for colon investigation is not based solely on clinical indication, but factors like delay, patient preference, lack of knowledge about the the procedures by the referring physician may have a decisive influence. the study will also analyse the correlation between patients symptoms, clinical findings and laboratory results and major pathology findings by colon investigation. further, delay from patient´s first symptoms to finally diagnosis by colon investigation will also be registered and analysed.

see extensive protocol in norwegian

Eligibility criteria:
inclusion criteria: * patients referred to colon investigation * patients must be 18 years or older exclusion criteria: * patients not able to give a written consent
real world information on cardiovascular drug management patterns in acute coronary syndrome patients

Conditions: Acute Coronary Syndrome

Summary: re-act is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for acs within 24 hours of symptom onset and who have a final diagnosis of st-segment elevation myocardial infarction (stemi) or non-st-segment elevation myocardial infarction (nstemi). this study aims to describe the short-term (at the end of the first month after index event) antithrombotic management patterns in a "real-life" setting for patients hospitalized with an acute coronary syndrome.


Eligibility criteria:
inclusion criteria: * provision of subject informed consent * patients hospitalized and diagnosed with stemi or nstemi * hospitalized within 24 hours of onset of symptoms or transferred from another hospital within 24 hours of the onset of symptoms exclusion criteria: * stemi and nstemi precipitated by or as a complication of surgery, trauma, or gi bleeding or post-pci. * stemi and nstemi occurring in patients already hospitalized for other reasons. * presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).

Keywords: acute coronary syndrome, antithrombotic management patterns,quality of life, acute clinical management strategies
a study of spd465 in young adult drivers with attention-deficit hyperactivity disorder (adhd) using driving simulators

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to determine whether spd465 is safe and effective in the treatment of adhd in young adult drivers after a duration of 16 hours.


Eligibility criteria:
inclusion criteria: 1. subject must have a valid driver's license with a minimum of 3 years of driving experience. 2. subject reports daily driving activity. 3. subject is fluent in english. 4. subject must be male or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol. 5. subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities 6. subject meets dsm-iv-tr criteria for a primary diagnosis of adhd) established by a comprehensive psychiatric evaluation that reviews dsm-iv-tr criteria exclusion criteria: 1. subject is significantly underweight or morbidly obese. 2. subject has a controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as post traumatic stress disorder (ptsd), psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder or other symptomatic manifestations that, in the opinion of the examining physician, will contraindicate spd465 treatment or confound efficacy or safety assessments. 3. subject with a lifetime history of psychosis or bipolar disorder. 4. subject with any concurrent chronic or acute illness or unstable medical condition, either treated or untreated. 5. subject with a history of mental retardation or a severe learning disability. 6. subject is naïve to adhd treatment with methylphenidate or amphetamine. 7. subject has a history of glaucoma or narrow angle glaucoma. 8. subject has a history of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of tourette's disorder. 9. subject has known cardiac structural abnormalities as well as any other condition that may affect cardiac performance. 10. subject has clinically significant ecg or laboratory abnormalities at screening or baseline. 11. subject has a history of hypertension or has a resting sitting systolic blood pressure \>139mmhg or diastolic blood pressure \>89mmhg10. 12. subject has used any psychoactive prescription medication or over-the-counter (otc) medication requiring more than a 28-day washout. hormonal contraceptives are acceptable. 13. subject has a documented allergy, intolerance, or documented history of non-responsivity to amphetamine. 14. subject currently has (or had a history within the last 6 months) a substance use disorder (excluding nicotine). 15. subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to screening. 16. female subject is pregnant or lactating.

Keywords: attention-deficit hyperactivity disorder (adhd)
a text message behavioral intervention to reduce alcohol consumption in young adults

Conditions: Alcohol Consumption; Alcohol Intoxication

Summary: investigators aim to test the effectiveness of a text-message-based behaivoral intervention in reducing binge drinking among young adults.

alcohol consumption, especially in the form of heavy episodic drinking (bingeing), is common among young adults. despite high rates of illness and injury associated with heavy episodic drinking, many young adults are not aware of the risks, few seek help for their drinking and many at-risk are not exposed to prevention-based intervention. opportunistic screening in hospital emergency departments (eds) tied to behavioral interventions has the potential to prevent future alcohol-related harm among young adults, but efficacy across outcomes has been mixed and large-scale implementation of prevention programs is low. given the rapidly growing use of cell phone text-messaging (sms) as a primary form of communication among young adults, sms could be used to deliver health prevention interventions. we will recruit young adults identified in the ed with hazardous drinking behavior in a 3-arm randomized controlled trial to test the hypothesis that exposure to a 12-week sms program will result in immediate (3-month) and lasting (6-, and 9-month) decreases in alcohol consumption.

Eligibility criteria:
inclusion criteria: * audit-c score 3 or more for women and 4 or more for men exclusion criteria: * current treatment for psychiatric disease * any prior treatment for drug or alcohol use disorder

Keywords: young adults alcohol consumption mobile health text message
comparison of 2 body oil in prevention of striae gravidarum

Conditions: Prevention Harmful Effects

Summary: the effect of elasticity belly® oil and clarins® tonic body treatment oil in prevention of striae gravidarum: a randomized controlled clinical trial.

objective: to compare the clinical efficacy of elasticity belly® oil and clarins® tonic body treatment oil on the occurrence and severity of striae gravidarum. design: parallel randomized controlled clinical trial. setting: gynaecology and obstetrics department, shanghai changning maternity and infant health hospital, china interventions: we will enroll about 50 nulliparous women randomly, who are in their second trimester of pregnancy. volunteer's abdomen skin are divided into two parts through medioventral line, half of the abdomen skin will receive the elasticity belly® oil to prevent striae gravidarum, and the other side will use the clarins® tonic body treatment oil. volunteers apply these two kinds of oil daily until gestational age of 38-40 weeks. we'll take abdomen pictures before and after interventions, and the occurrence of striae on abdominal skin and its severity will be evaluated as our primary outcome of the study.

Eligibility criteria:
inclusion criteria: * nulliparous females * gestational age of 14-20 weeks * 20 to 35 years old * body mass index (bmi) from 18.5 to 25 * clear consciousness, intelligence is normal,stable vital signs * voluntary participation, and sign the informed consent exclusion criteria: * allergy to skin care products * twin pregnancies or polypregnancies * polyhydramnios * miscarriages * development of a skin disease * corticosteroid usage * application of any other cream on the abdominal skin * did not received allocated intervention * drop out or lost to follow-up
treatment efficacy of budesonide/formoterol in cough variant asthma and typical asthma patients

Conditions: Bronchial Asthma

Summary: bronchial asthma is a common respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. generally, asthma is a heterogeneous disease, and it could be classified into many types on the basis of symptoms, that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc. typical asthma (ta) is defined according to the history of repeated respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow limitation, airway hyper-responsiveness, and airway remodeling. cough variant asthma (cva) is characterized by the single manifestation, recurrent cough, which could be improved after the use of bronchodilators. however, according to different guidelines, it is still controversial on the treatment of cva and ta. the guidelines of global initiative for asthma(gina) in 2014 put forward the treatment of ta patients, but did not list the treatment specific to cva. the guideline of accp（american college of chest physicians） and cough guidelines of china are proposed to treat the cva effectively with bronchial diastolic drug. inhaled corticosteroids (ics) and leukotriene receptor antagonists are effective for the treatment of cva. currently, more and more studies supported that application of ics combined with bronchial dilation agents is more beneficial to cva patients. budesonide/formoterol is a compound of ics and long-acting beta2-agonist(laba), which can not only be used as a maintenance medication, but also be used as a relief medication, namely, budesonide/formoterol treatment regimen for smart (symbicort as both maintenance and reliever therapy). most studies show that smart treatment can be used in the treatment of ta patients. but the study on whether budesonide/formoterol can be used to treat cva is still little. to provide basis for clinical medication guidance for patients with cva and ta, this study will enroll 30 patients with ta or cva , who will be required to adopt the smart regimen in the following 6 months.the symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be measured every mouth. after the study finished, the investigators will compare the difference between the two groups.


Eligibility criteria:
inclusion criteria: 1. aged 15-75 2. first diagnosed corresponding to the diagnostic standards established by asthma committee, respiratory society, chinese medical association, or previously diagnosed asthma without regular treatment 3. mch bronchial provocation test is positive 4. the chest x-ray is normal. exclusion criteria: 1. accompanied by other disease of respiratory system 2. combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on 3. women with pregnancy or lactation.

Keywords: budesonide/formoterol typical asthma cough variant asthma