Kornimate/medical-research-clean huggingface dataset:
cardiovascular effects of incremental diesel exhaust inhalation in middle-aged healthy gstm1 null human volunteers

Conditions: Healthy

Summary: purpose: a growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollutants. reactive oxygen species (ros) have been implicated as a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of the glutathione-s-transferases (gsts) have been shown to participate in the antioxidant defenses to air pollutants. this study examined the dose effects of diesel exhaust exposure on the cardiovascular system in healthy middle-aged subjects. participants: six healthy 50-75 year-old male and female subjects with gstm1 null genotype had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3, 200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.


Eligibility criteria:
inclusion criteria: * age 50-75 years old generally healthy male and female. * normal resting ecg. * oxygen saturation greater than 94% at the time of physical exam. exclusion criteria: * a history of angina, cardiac arrhythmias, and ischemic myocardial infarction or coronary bypass surgery. * cardiac pacemaker. * uncontrolled hypertension (\> 150 systolic, \> 90 diastolic). * neurodegenerative diseases such as parkinson's and alzheimer disease. * a history of chronic illnesses such as diabetes, cancer, rheumatologic diseases, immunodeficiency state, known cardiovascular disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma. * history of bleeding diathesis. * currently taking hmg-coa reductase inhibitors for hyperlipidemia including lovastatin, pravastatin, simvastatin, and atorvastatin. * currently taking beta-blockers to control hypertension and/or arrhythmias. * use of oral anticoagulants. * participants must refrain from all over-the-counter nsaids for a period of two weeks prior to exposure. low-dose aspirin will be acceptable. medications not specifically mentioned here may be reviewed by the investigators prior to a participant's inclusion in the study. * subjects who are currently smoking or have smoking history within 1 year of study (defined as more than one pack of cigarettes in the past year). * subject is pregnant, attempting to become pregnant or breastfeeding. * no exposure will be conducted within 4 weeks of a respiratory tract infection.

Keywords: risk of cardiovascular events
effect of camel milk with probiotic on type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to investigate the effects of dietary supplement with camel milk containing bifidobacterium animalis a6 on the plasma glucose and other related cytokines in patients with type 2 diabetes mellitus. 45 patients with type 2 diabetes mellitus were recruited, and a double blind randomized parallel controlled trial was performed. the fasting glycaemia, 2 hour postprandial glycaemia, insulin, uric acid and serum lipid (total cholesterol, total triglyceride, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol ) were measured as primary outcome. the fecal microbiome, fecal metabolites, gut hormones (amylin, ghrelin, glucagon-like peptide 1, pancreatic polypeptide), inflammation cytokines (tnf-α, il-6, mcp-1), myokines (fgf-21, irisin, osteocrin/musclin, osteonectin) and adipokines (adiponectin, resistin, lipocalin-2, adipsin) and body composition analysis were also assessed.


Eligibility criteria:
inclusion criteria: * age between 35\~68 years old * patients who diagnosed as type 2 diabetes * agree to take the products to be studied during the study period, and no longer take other fermented dairy products (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) and antibiotic * agree to sign the informed consent form exclusion criteria: * taking antibiotics or antifungal drugs within 7 days before the study * have serious allergic reaction to skim milk powder or milk * researcher are not sure whether the subjects are willing or able to complete the study * subject had other serious diseases

Keywords: camel milk probiotics gut microbiome
stress cmr in patients with coronary chronic total occlusions

Conditions: Coronary Chronic Total Occlusions

Summary: a total chronic occlusion (cto) is defined as a coronary obstruction with timi 0 flow lasting at least 3 months.the prevalence of cto in patients with coronary disease is about 10-40%. coronary collateralizations may supply sufficient perfusion to retain tissue viability, but do not protect from myocardial ischaemia. in fact, percutaneous revascularization (pci) of cto lesions leads to improved symptoms, functional class, quality of life, higher left ventricular ejection fraction and improved survival in several observational studies. however, due to the higher rate of procedural complications and lower success rate of pci than in other settings, it is attempted in only 10% of all cto lesions. myocardial viability/ischaemia assessment should be performed before pci to avoid potential pci-related complications and identify patients who might benefit most from myocardial revascularization, individualizing the risk-to-benefit ratio. in this regard, patients with stable coronary artery disease who have moderate-to-severe ischaemia are at higher risk of event rates (death or mi of \~5%/year) and plausibly represent the best target for pci. cardiac mri (cmr) provide a reliable assessment of both myocardial ischaemia and viability. using late gadolinium enhancement (lge) sequences, myocardial segments with lge \>75% of transmurality do not show any improvement in contractility even after revascularization, representing a subset of patients in which cto pci may be futile. viability assessment by cmr may be also performed with low dose dobutamine infusion; in patients with cto and akinetic segments, contractility improvement at low dose dobutamine may predict functional recovery in the follow-up. myocardial ischaemia may be assessed by cmr with high accuracy, identifying perfusion defects during pharmacological-induced hyperemia and/or regional wall motion abnormalities during inotrope infusion. this study is designed to verify the hypothesis that myocardial ischaemia and viability assessed by cmr could identify patients who are more likely to benefit from pci in terms of improvement in left ventricular remodeling, functional recovery and clinical outcome.


Eligibility criteria:
inclusion criteria: * angiographic diagnosis of coronary chronic total occlusion (timi 0 lasting more than 3 months, if known) * baseline stress cmr * signed informed consent exclusion criteria: * cmr contraindications * severe ckd * contraindications to adenosine or dobutamine * unable/unwilling to sign informed consent * pregnancy

Keywords: myocardial ischaemia myocardial viability coronary chronic total occlusions cardiac magnetic resonance stress cmr
assessing the benefits of the vibraject attachment

Conditions: Pain

Summary: behavioral and physiologic observations suggest that the injection of local anesthetic is among the most feared or anxiety producing procedures during dental intervention. discomfort during the injection is currently reduced by pharmacologic or mechanical methods. no technique has proven to be effective for every patient. the vibraject llc (usa) was first introduced in 1995 and was developed under the hypothesis that a vibrating needle would stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying the pain signal from the injection site. studies on adult patients have been promising. the purpose of this study is to investigate the efficacy of the vibraject dental syringe attachment in reducing injection discomfort and procedural anxiety in the pediatric dental population.

one hundred children will be recruited from the unmc pediatric dentistry clinic. eligible children will be selected from the 4-6 year group who are scheduled for routine dental restorative treatment and who have or have never received a dental injection. each patient will randomly participate in either a control or experimental condition. the device will be attached for both conditions. during the control injection, the dentist will perform the dental injection as usual. during the experimental injection, the dentist will activate the attached device and perform the injection. immediately following each injection, the patient will rate the pain on a visual analog scale and a trained observer will rate the child's behavior on a frankl behavior scale. a videotape of the procedure will be reviewed by an independent dentist who will evaluate the child's response and any perceived disruptive behavior. this observer will be blind to whether the instrument is functioning.

Eligibility criteria:
inclusion criteria: 1. attending the unmc pediatric dentistry clinic for dental restorations requiring injection of local anesthetic for restorative procedures with or without use of inhalation anesthesia but without physical restraint 2. age 4 to 8 exclusion criteria: 1. no parent or legal guardian is present 2. parent does not give consent 3. non-english speaking participants will be excluded because pi is english speaking and this study needs behavior guidance of children that only the dentist can deliver and not an interpreter.
desensitization protocol for deceased donor list

Conditions: Transplant; Failure, Kidney

Summary: purpose of the study: the specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant ivig treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.

background: intravenous immunoglobulin (ivig) infusion is one of several novel approaches to decrease antibody levels for highly sensitized kidney transplant candidates \[1, 2\]. this approach can potentially give a chance of kidney transplantation to end-stage renal failure patients who could never receive transplantation because of high levels of antibodies and persistent positive crossmatches to all potential kidney donors. many transplant centers have used this strategy in order to increase transplant rates of highly sensitized patients with various levels of anti-hla antibodies. however, the responses to the treatment seem to be different in each patient and factors affecting treatment outcome have yet to be determined.

Eligibility criteria:
inclusion criteria: * recent (\< 3 months) high levels of anti-hla antibodies (at least one cpra ≥ 40%). * waiting time greater than 1 year for blood type ab, 2 years for blood types a, b, or o. exclusion criteria: * female subject is pregnant or lactating. * subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives. * subject has an uncontrolled active hepatitis b, hepatitis c, or hiv infection. * subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation. * subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.
salivary tas, tos, ll-37 and dental status in passive smoking children

Conditions: Passive Smoking; Oxidative Stress; Dental Caries; Children

Summary: the aim of the present study was to determine the effect of passive smoking on the levels of salivary tas, tos, ll-37 and dental status in children.in the study the parents of children were asked to fill out a complete survey about smoking habits. after filling out the questionnaire, according to the survey results, a total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). dental examination of children were performed and caries prevalance of the patients were recorded. unstimulated saliva samples were collected from children. saliva 'cotinine levels' which are expected to increase in passive smoking group; 'antimicrobial peptide ll-37' and oxidative stress markers 'total antioxidant status' (tas), and' total oxidant status' (tos) were evaluated by using enzyme-linked immunosorbent assay (elisa). the obtained data parameters of the two groups were evaluated and comparison was performed.


Eligibility criteria:
inclusion criteria: -systemically healthy children exclusion criteria: * the presence of orthodontic / intraoral appliance * any disease or condition known to affect defense system * uncooperative children
qualitative research to explore treatment preference in pulmonary arterial hypertension (pah) subjects

Conditions: Hypertension, Pulmonary

Summary: glaxosmithkline (gsk) is embarking on a clinical program to assess the treatment of pah with an angiotensin converting enzyme 2 (ace2). this new treatment may require subcutaneous administration, in comparison to current treatments which are taken orally. hence, gsk would like to conduct this qualitative interview study with pah subjects to explore subject's perspective and preferences for various modes of treatment administration (daily or weekly subcutaneous injection versus current treatment options). this will be a qualitative study comprising the conduct of semi-structured telephone concept elicitation interviews with 8 to 10 pah subjects (each approximately 30 minutes in duration) in the united states (us).


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age. * subject is willing and able to provide written informed consent. * subject must have a diagnosis of symptomatic pulmonary arterial hypertension type i as per the world health organization (who) clinical classification system. * subject must have the cognitive and linguistic capabilities sufficient to allow them to actively participate in an interview lasting 30 minutes. exclusion criteria: * subject has a diagnosis of other cardiac or pulmonary disease. * subject has a type ii-v diagnosis of pah, as per the who clinical classification system. * subject is currently receiving treatment for pah via modes of administration other than intravenously or orally.

Keywords: telephone interviews subcutaneous low-interventional qualitative research pah
januvia re-examination study (mk-0431-181)

Conditions: Type 2 Diabetes Mellitus

Summary: the objectives of this survey are: 1) to examine the safety/efficacy profile of januvia in korean participants, and 2) to identify factors that might have an influence on the safety and efficacy profile of januvia in korean participants. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * treated with januvia within local label for the first time exclusion criteria: * contraindication to januvia according to the local label * treated with januvia before contract and out of enrollment period inclusion criteria for long-term surveillance * treated with januvia for more than or equal to 24 weeks
myopia progression after ceasing myopia control contact lens wear

Conditions: Myopia

Summary: this is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an fda-approved marketed spherical soft contact lens.


Eligibility criteria:
inclusion criteria: 1. the subject must be enrolled in the parent protocol for at least one year. 2. the subject's parent or legal guardian must read and sign the statement of informed consent and the subject must read and sign the child's assent form and be provided a copy of each form. 3. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: 1. ocular or systemic allergies that may interfere with contact lens wear. 2. systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear. 3. clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. 4. clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear. 5. any ocular infection. 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. hiv) 8. diabetes 9. previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. rigid contact lens wearers cannot be enrolled in the study. 10. strabismus. 11. pupil or lid abnormality or infection in either eye 12. central corneal scar in either eye 13. aphakia in either eye 14. contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear. 15. history of participation in prior clinical trials aimed to control myopia progression, except for the parent trial 16. surgically altered eyes, ocular infection of any type, ocular inflammation. 17. anterior chamber angle grade 2 or narrower by van herrick method.
multicenter exploratory study of accelerometry in dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: study evaluates the relationships between daily physical activity levels (pal) and functional capacity (vo2peak) in patients with dilated cardiomyopathy (dcm)

the study will evaluate the daily physical activity with the use of activity monitor, heart rate monitor and event monitor in patients with dilated cardiomyopathy (dcm). these wearables track the heart rate, heart rhythm, tracks activity and step count. the vo2 peak will be measured via the exercise test.

Eligibility criteria:
inclusion criteria: 1. males and females, 18-75 years of age 2. diagnosis of dilated cardiomyopathy * (unexplained left ventricular enlargement (left ventricular end diastolic dimension (lvedd) \>95th percentile for gender and height by echo or mri) * (left ventricular ejection fraction (lvef) less than 50%) 3. cpet within 14 days prior to baseline visit with no intervening change in therapy 4. echocardiogram or cardiac mri within 1 year prior to baseline 5. able to walk \>100ft without limitation 6. more than 30 minutes of exercise per week for at least 3 months prior to study enrollment, and plan to continue exercising for the next two weeks (duration of study). 7. ability to provide informed consent and willingness to complete the study (including weekly phone follow-up) exclusion criteria: 1. heart failure hospitalization within four weeks prior to enrollment 2. non-cardiac limitation of activity 4. prior exercise-induced syncope or exercise-induced sudden death 5. primary exercise mode is swimming or stationary biking 6. participation in competitive or high intensity exercise against medical advice 7. implantable cardiverter defibrillator (icd) placement in the 2 months prior to enrollment 8. plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study
cytokines associated with cord blood cell therapy for neonatal encephalopathy

Conditions: Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)

Summary: this is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.

the effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. this is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). this study proceeds along with the study "autologous cord blood cell therapy for neonatal encephalopathy (clinicaltrials.gov identifier: nct02256618)". blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.

Eligibility criteria:
inclusion criteria: infants are eligible if they meet all the following inclusion criteria except 4. 1. ≥36 weeks gestation 2. either a 10-minute apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as ph \<7.0 or base deficit ≥16 mmol/l in a sample of umbilical cord blood or any blood during the first hour after birth 3. moderate to severe encephalopathy (sarnat ii to iii) 4. a moderately or severely abnormal background amplitude-integrated eeg (aeeg) voltage, or seizures identified by aeeg, if monitored 5. up to 24 hours of age 6. a person with parental authority must have consented for the study. exclusion criteria: 1. known major congenital anomalies, such as chromosomal anomalies, heart diseases 2. major intracranial hemorrhage identified by brain ultrasonography or computed tomography 3. severe growth restriction, with birth-weight less than 1800 g 4. severe infectious disease, such as sepsis 5. infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia by the attending neonatologist

Keywords: neonatal encephalopathy hypoxic-ischemic encephalopathy newborn infants cytokines trophic factors