Kornimate/medical-research-clean huggingface dataset:
a study to assess the effect of bms-986142 on pharmacokinetics (pk) of probe substrates

Conditions: Rheumatoid Arthritis

Summary: the study is being conducted to assess the effect of bms-986142 on the single-dose pk parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for (cytochome p450) cyp2c8, cyp2c9, cyp2c19, cyp3a4, and p-glycoprotein (p-gp), respectively.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. target population: healthy (current non-smokers) subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ecg), and clinical laboratory determinations. 3. subjects with body mass index of 18 to 32 kg/m2, inclusive 4. men, and women of nonchildbearing potential. women must have documented proof that they are not of childbearing potential and must not be breastfeeding. 5. males who are sexually active with women of childbearing potential (wocbp) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days (approximately 14 weeks) after treatment completion. female partners of male subjects are expected to use one of the highly effective methods of contraception listed in the protocol. exclusion criteria: 1. history of any chronic or acute illness, recent infection, gastrointestinal disease, smoking and alcohol abuse, any significant drug allergy or allergy to digoxin, flurbiprofen, midazolam, omeprazole, or montelukast, bruton's tyrosine kinase (btk) inhibitors, immunologic or related compounds. 2. history of billiary disorder, asthma, bleeding disorder, cancer 3. received live vaccine during last 12 weeks, active tuberculosis (tb) in last 3 years 4. medical history indicative of an increased risk of arrhythmia. 5. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population.
effects of surgery types in patients with pulmonary nodules

Conditions: Pulmonary Nodule

Summary: the investigators aimed to compare the pre-post operative effects of video-assisted thoracoscopy surgery (vats) and thoracotomy on pulmonary function, exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain in patients with pulmonary nodules.

according to global cancer statistics, lung cancer accounts for 11.6% of all cancer cases and it is the most common type of cancer in the world. surgery is the primary treatment approach, especially in early stages lung cancer. cardiopulmonary fitness of patients with lung cancer is lower than healthy individuals due to the disease itself and treatments. pulmonary function, exercise capacity and physical activity level are affected in lung cancer depending on the resected lung tissue and the type of surgery. vats and thoracotomy surgeries, which are the most preferred techniques in lung cancer, have advantages and disadvantages over each other. there are few studies compared the early effects of two surgeries on the pulmonary function, exercise capacity, physical activity, quality of life and fatigue. and also, no study compared the effects of two surgeries on respiratory muscle endurance and peripheral muscle strength, previously. according to sample size calculation, at least 15 patients with pulmonary lesion both vats and thoracotomy groups would be included in the study. the demographic, physical and physiological characteristics were recorded from the patient files. pulmonary function, functional exercise capacity, physical activity level, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain were evaluated pre and two weeks after postoperative term. primary outcomes were pulmonary function, functional exercise capacity and physical activity level. secondary outcomes were respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life, fatigue, dyspnea perception and pain.

Eligibility criteria:
inclusion criteria: * being between 18-80 years of age, * patients with pulmonary nodule who were planned lobectomy surgery with one of vats or thoracotomy techniques, * being able to walk, exclusion criteria: * any type of surgery planned except lobectomy, * having heart failure or atrial fibrillation, * having acute viral infections during all assessment, * history of acute myocard infarction within last six months, * uncontrolled diabetes or hypertension, * having orthopedic, neurological and psychological disorders that influence the results of study.

Keywords: pulmonary nodule pulmonary function functional exercise capacity physical activity respiratory muscle strength respiratory muscle endurance quality of life
effectiveness of on-demand meteospasmyl® use in irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to compare the effectiveness of 2 ibs treatment strategies: * strategy a = meteospasmyl®, on-demand therapy * strategy b = standard of care chosen by the physician


Eligibility criteria:
inclusion criteria: * male or female ambulatory patients, aged \>= 18 years * with ibs as defined by rome iii criteria for more than 1 year and less than 10 years * with a ibs-sss between 175 and 400 exclusion criteria: * acute diarrhea, bowel disorders due to an underlying cause * patient treated with meteospasmyl® within the past 6 months * recent history of gastro intestinal surgery
comprehensive computed tomography guidance of coronary bypass graft surgery

Conditions: CAD; Atheroscleroses, Coronary; Computed Tomography; Coronary Artery Bypass

Summary: apply ct angiography, ct perfusion imaging and advanced image processing techniques to improve revascularization decision-making and surgical strategies in patients undergoing coronary artery bypass graft surgery.

the objective of this study is to integrate noninvasively acquired anatomical and functional information to develop clinically applicable tools for meaningful per-vessel revascularization decisions. the decisions will be based on quantitative lesion-specific ischemia and viability and flow simulations. these will be based on ct anatomy enhanced with a function for prediction of hemodynamic improvement after cabg. aim 1: predict restoration of myocardial perfusion from coronary artery bypass graft surgery. the investigators will perform cardiac ct before and after cabg and measure absolute changes in myocardial perfusion as the functional outcome of cabg. the investigators will investigate clinical, surgical and imaging variables in association with post-cabg perfusion improvement on a per-vessel and per-patient level. aim 2: non-invasively quantify vessel-specific ischemia for meaningful cabg decisions. the investigators will develop and validate tools for assessment of vessel-specific ischemia and viability. the investigators will assess the potential impact of ct guided cabg by comparing the per-vessel need for grafting with standard care. aim 3: predict cabg benefit through multi-parameter flow simulations hypothesis: integration of myocardial perfusion and viability can improve flow simulation models to predict cabg outcome. the investigators will develop new computational fluid dynamics models enriched with functional parameters and explore the potential of virtual grafting to improve hemodynamic outcomes.

Eligibility criteria:
inclusion criteria: * planned elective cabg for coronary artery disease. * cabg is the primary indication for surgery (but may include treatment of mild-moderate valvular disease). * age: ≥40 years. exclusion criteria: * technical feasibility of the cardiac ct exams: redo-cabg, significant arrhythmia/mal-conduction, congenital conditions, severe valvular disease or cardiomyopathy (to the extent that the ct acquisition is technically challenged), inadequate understanding of the english language (to provide consent or follow instructions during the exams). * overall safety: unstable clinical condition (clinical heart failure, unstable angina, myocardial infarction \<1 month prior). * radiation risk: pregnancy (cannot be ruled out), body weight \>100kg. * ct contrast medium-related: known allergy, renal failure * vasodilator related: known allergy, bronchial asthma requiring daily use of bronchodilators, mobitz ii or 3rd degree av block, sick sinus node disease, clinically significant carotid artery narrowing, severe aortic stenosis or lvot narrowing, systolic blood pressure below 90mmhg, (continued) use of dipyridamole or aminophylline. * inability to provide informed consent.
a study of the human anti-tnf antibody adalimumab for the induction of clinical remission in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active crohn's disease when compared to placebo (an inactive substance)


Eligibility criteria:
inclusion: * diagnosis of crohn's disease * cdai score at baseline of between 220 and 450 * normal laboratory parameters * willing and able to give informed consent exclusion: * diagnosis of ulcerative colitis * women cannot be pregnant or breastfeeding * no previous use of infliximab or other anti-tnf antagonists * no previous history of tuberculosis or listeria infection * no previous history of cancer other than successfully treated skin cancer
comparison between direct composite and indirect ceramic laminate veneers in multiple diastema closure cases

Conditions: Dental Leakage

Summary: thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using usphs criteria. the formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years.

restorative materials and curing device in the current study, the manufacturer's instructions were followed for the use of the nanofilled composite resin (estelite asteria, tokuyama dental, japan) for direct laminate veneers and ips e.max press (ivoclar vivadent, amherst, ny, usa) for indirect laminate ceramic veneers. a light curing device with an output density of 655 mw/cm2 (led bluephase c5, ivoclar, vivadent, amherst, ny, usa) was used. demetron led light meters were used to measure the light curing unit's intensity regularly (demetron research corp., danbury, ct, usa). brand name, description, chemical composition, and manufacturers of the materials are presented in table 1. study design, blinding \& randomization the consolidated standards of reporting trials statement was adhered to in the description of the experimental design. this study was a randomized controlled clinical trial that was double-blinded for both trial participants and outcome assessors. randomization was performed using the flip of a coin for the choice of material. using computerized sequence generating (www. randomizer.org), participants were divided into two groups with a 1:1 allocation ratio.

Eligibility criteria:
inclusion criteria: * patients needed diastema closure. * patients with normal and full occlusion. * patients must have a good oral hygiene. * patients with a tooth respond positively to an electric pulp tester. exclusion criteria: * high caries risk patients with extremely poor oral hygiene. * patients with periodontally-involved teeth. * patients with heavy bruxism habits and clenching. * patients involved in orthodontic treatment.

Keywords: ceramics composite randomized clinical trial diastema closure
noninvasive ventilation masks carbon dioxide clearance in normal volunteers

Conditions: CO2 Clearance; Mask Comfort; Rebreathing Exhaled Gas

Summary: this study will be a randomized crossover trial that will be conducted at rush university. the study will be conducted with 20 healthy volunteers who will be placed on icu ventilator operating in the nippv mode. all subjects will perform 15 minutes of breathing on nippv on each mask of the 4 different masks (2 oronasal and 2 full face masks) that are randomly selected. breathing through each mask will be followed by a 5- minute wash out period between masks. end tidal carbon dioxide (etco2) will be sampled nasal/oral. different levels of epap will be set and co2 clearance will be monitored. additionally, subjective mask comfort will be assessed via visual analog scale (vas) with 1 referring to least comfortable and 5 being the most comfortable.

this study will be a randomized crossover trial that will be conducted at rush university. normal volunteers will be recruited from rush university medical centers. volunteers will be screened with inclusion and exclusion criteria and an informed consent is required in order for them to participate. also, initial baseline vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be obtained. etco2 will be obtained at baseline and periodically using an oral/nasal sample line with the capnostreamtm 20p monitor (medtronic, minneapolis, mn). the study will use a double limb circuit icu ventilator puritan bennett™ (medtronic, dublin, ireland). investigators will evaluate 4 nippv masks (2 oronasal masks and 2 full face masks). oronasal masks will be labeled as group a and numbered as a1 and a2; while full face masks will be labeled group b and numbered as b1 and b2. order of the masks will be randomly chosen in two steps. first steps will be choosing a or b then randomly assign mask in each of these groups. investigators will randomly assign mask in group a or b by drawing an initial mask from the group and then continue the sequence of masks from that point. for example, investigators randomly chose group a, then randomly chose a2, the sequence will be a2, a1. then investigators would randomly choose b2, then the sequence would be b2, b1. all subjects will perform 15 minutes on each mask followed by 5 minutes wash out interval between masks. epap levels will be 0, 2, 4, \& 5 while ipap remains at 5 higher than epap. etco2 will be collected at 4:00, 4:30 and 5:00 minute mark. these three measures should differ by less than 20% of their average. also, subjective mask ora: 18011502-irb01 date irb approved: 3/30/2018 amendment date: 5/11/2018 comfort will be assessed via visual analog scale (vas) with 1 referring to least comfortable and 5 being the most comfortable after 5 each epap setting.

Eligibility criteria:
inclusion criteria: * healthy subjects greater than 18 years old. exclusion criteria: * prior history of nippv as a patient. * facial surgery or deformity * ear infection * history of pulmonary or cardiac disease
prince study - cohort study of healthy pregnant women followed by the assessment of children´s health and immunity

Conditions: Pregnancy; Immune System Disorder

Summary: in the prince study we recruit healthy but also diseased pregnant women into a cohort study, followed by the assessment of children´s health and immunity at birth and during the first 10 years of life. this unique cohort allows for testing the impact of prenatal challenges on children´s health.

children´s health is critically dependent of the prenatal well-being of the mother, and a number of observational studies have identified an impaired immunity in children upon prenatal challenges, such as stress perception, medication, nutrition or infection. however, concerted, in-depth studies assessing how such prenatal challenges may alter fetal development and subsequently children´s health in humans are largely lacking. in the present project, we address this limitation by recruiting healthy, but also diseased pregnant women into a cohort study, followed up by the assessment of children´s health and immunity at birth and during the first ten years of life. study participants are recruited early in the first trimester (12-15 weeks of gestation). by means of data security all participants receive a study number. data processing into the data base (redcap) is performed under this pseudonym. during the first visit, the study team explains the enrollment conditions and the participants are asked to give their consent. study visits include the documentation of clinically important conditions, sonographic examination of the fetus, assessment of mother´s height and weight as well as blood collection (21 ml) of the mother. additionally we document any kind of medication-intake and nutrition data, and the participants are asked to fill in a psychometric questionnaire. study visits are scheduled according to the week of gestation, i.e. around 13th, 20th (ultrasound only), 24th, 28th, 34th week. if women give birth in our clinic, we are able to collect cord blood after birth. blood samples are processed immediately and stored in our laboratory under biobank-conditions.

Eligibility criteria:
inclusion criteria: * pregnant women * \>18 years of age * able to understand and sign the papers of consent * singleton pregnancy exclusion criteria: : * \<18 years of age * unable to give consent * multiple pregnancy * nicotine abuse * fetal aberration

Keywords: pregnancy immune system birth cohort fetal programming
biliary hilar drainage managed by endoscopy

Conditions: Hilar Biliary Strictures

Summary: the management of hilar biliary strictures remains difficult. these strictures are classified in 4 types (i,ii,iii and iv). in palliative cases, an endoscopic drainage should be performed in types i and ii while a percutaneous drainage is performed in type iv. there is controversy as to whether partial or complete liver drainage should be done. furthermore there are no standards for drainage types (metallic stents, plastic stents). morbidity remains high and a multistage procedure can be required. this study aims at evaluating the clinical practices in the investigators' center in order to determine the key factors that contribute to the drainage success or failure.


Eligibility criteria:
inclusion criteria: * age \>18 years * biliary strictures requiring a drainage exclusion criteria: * contraindication to hilar biliary drainage
effects of modafinil in methamphetamine dependence

Conditions: Methamphetamine Dependence

Summary: methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. relapse rates are high in this population. exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. the proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.


Eligibility criteria:
inclusion criteria: 1. subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 2. subjects must meet dsm-iv criteria for methamphetamine dependence within the past six months. subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. nicotine use immediately prior to the cue reactivity testing session will be controlled. 3. subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions. 4. subjects must consent to random assignment to the modafinil vs. placebo conditions. exclusion criteria: 1. women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control. 2. subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement. 3. subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity. 4. subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures. 5. subjects meeting dsm-iv criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days. 6. subjects currently taking b-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring. 7. known or suspected hypersensitivity to modafinil. 8. individuals taking medications that could adversely interact with study medications. 9. subjects with a history of epilepsy or seizure disorder.

Keywords: methamphetamine modafinil addiction craving cognitive
sucking and sucrose as pain relief for infants

Conditions: Pain

Summary: sucking and sucrose have been shown to reduce pain during venous puncture in neonates. our study is designed to see if sucking and sucrose relieve pain during venous puncture in infants age 3-12 months.

100 infants age 3-12 months old without neurologic, developmental or cardio-respiratory impairment, needing venous puncture for iv access, or blood aspiration, will be randomly assigned to one of 2 groups - with or without pacifier. during the puncture, each patient with pacifier will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly) . each patient without pacifier 2 will receive 1 cc of water without pacifier,will receive either 1 cc of water or 1 cc of sucrose (the solutions prepared and marked blindly). flacc pain score will be used for apin assessment before, during and after the puncture.comparison of the four groups will be done after the end of the study.

Eligibility criteria:
inclusion criteria: * age 3-12 months * hospitalized in pediatric ward b * need venous puncture exclusion criteria: * neurological deficit * developmental delay * cyanotic heart disease * symptomatic respiratory disease * known problematic venous access

Keywords: sucrose sucking pain relief infant require venous puncture