Kornimate/medical-research-clean huggingface dataset:
a phase i study to evaluate xtr003 in healthy chinese volunteers

Conditions: Coronary Artery Disease (CAD)

Summary: 18f-fdg pet imaging is now considered the most effective method used in the clinical evaluation of viable myocardium. however, the need for fasting or glucose and insulin loading in the 18f-fdg pet protocol makes it unfavorable for a certain group of patients (i.e., insulin-resistance and diabetic patients). xtr003 is a fatty acid analog used for pet imaging, developed at the beijing anzhen hospital affiliated to sinotau pharmaceutical group. xtr003 is a promising fatty acid analog and perhaps have a potential clinical utility in the evaluation of viable myocardium. this phase i study investigated the safety, biodistribution, radiation dosimetry and pharmacokinetics of xtr003 in 10 chinese normal healthy volunteers both male and female between the ages of 18-40.

xtr003 is a pet imaging radiopharmaceutical agent used to trace myocardial fatty acid metabolism. xtr003 is a modified fatty acid that enters the myocytes and passes through mitochondrial membrane by the same process as the natural existing fatty acids and then undergoes partial β-oxidation before being trapped in the mitochondria. in preclinical study xtr003 showed high myocardial uptake and retention \[1\]. this is a phase i study, the study will be open-label, nonrandomised, single-arm, single-center clinical study. subjects will receive single dose of xtr003. safety, biodistribution, radiation dosimetry and pharmacokinetics was investigated.

Eligibility criteria:
inclusion criteria: 1. men and women aged between 18-40 years 2. normal electrocardiogram and echocardiography 3. normal vital signs and physical examination 4. no any major illness 5. no clinically significant abnormalities in laboratory tests 6. no clinically significant anomalies in 12-lead ecg 7. females of child bearing possibility should adopt effective medically approved contraceptive methods to prevent pregnancy for at least 6 months before the study and after the study 8. voluntarily signed written consent from all subjects exclusion criteria: 1. pregnancy or lactating woman 2. history of cardiovascular disease 3. history of any brain disease 4. history of coagulopathy 5. history of liver or gastrointestinal diseases or other factors that can interfere with drug absorption, distribution, excretion or metabolism 6. past history of cancer 7. history of drug allergy 8. history of drug abuse or alcohol dependance 9. any medications and treatments that may interfere with the test data or may cause serious side effects 10. human immunodeficiency virus (hiv), hepatitis c or syphilis antibody test positive, hepatitis b surface antigen positive 11. exposure to significant occupational radiation (e.g \>50 mvs/year) or exposure radioactive substances for therapeutic or research purposes over the past 10 years 12. use of health products or medications (eg. coenzyme q10, etc.) that have an effect on myocardial energy metabolism within 1 week 13. hospital admission due to illness during the screening period

Keywords: coronary artery disease; positron emission tomography (pet)
ultrasonography versus palpation for spinal anesthesia in obese parturients undergoing cesarean delivery

Conditions: Anesthesia, Spinal; Cesarean Section; Spinal Ultrasound

Summary: the study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery

this randomized, controlled, double-blind study will be conducted on asa physical status ii-iii obese parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. the study subjects will be assigned to 2 equal groups. in the ultrasonography group, lumbar spinal ultrasonography will be performed before administration of spinal anesthesia. in the palpation group, conventional palpation of the anatomical landmarks will be performed.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status ii-iii parturients * full term singleton pregnancy * body mass index ≥ 35 kg/m2 exclusion criteria: * age \< 19 years * women presenting in labor * contraindications to neuraxial anesthesia (coagulopathy, increased intracranial pressure, or local skin infection) * significant spinal deformities or previous spinal surgery * preeclampsia
vitamin d deficiency and asthma exacerbation

Conditions: Asthma; Vitamin D Deficiency; Disease Exacerbation

Summary: the study aim is in two phases. first phase: to evaluate the influence of vitamin d deficiency on asthma severity, degree of airway obstruction and frequency of asthma exacerbations. second phase: to evaluate if in patients with vitamin d deficiency (25-oh vitamin d levels below 20 ng/ml), vitamin d supplementation decreases the number of disease exacerbations.

the first phase of the study consisted of a cross-sectional examination of a cohort of 119 asthmatic patients, who had at least one year regular follow-up in our respiratory clinic, and were not receiving any vitamin d supplementation. in the second phase patients with vitamin d deficiency (25-oh d values below 20 ng/ml), were recruited in a one year longitudinal study, during which they received vitamin d supplementation. the study started and ended in late autumn-winter season when, at our latitude, sun exposure is lowest. symptoms, spirometry and number of exacerbations were recorded during both study phases.

Eligibility criteria:
inclusion criteria: * all the consecutive patients with bronchial asthma of any severity, who presented for a scheduled visit at our respiratory clinic during the period october 2012-march 2013 and who had at least one year regular follow-up every three months exclusion criteria: * acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.

Keywords: asthma vitamin d exacerbations airway obstruction
biomarkers for predicting neoadjuvant chemoradio-resistance for middle-low advanced rectal cancer

Conditions: Rectal Cancer; Cancer of Rectum; Cancer of the Rectum; Neoplasms, Rectal; Rectal Tumors; Rectum Cancer; Rectum Neoplasms

Summary: neoadjuvant therapy has been widely applied to locally advanced rectal cancer. however, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their t or n stages are not effectively decreased judged by postoperative pathological examination. the purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. these biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.

according to postoperative pathological examination results, all participants will be divided into two groups: complete response (ypt0n0) and poor response (\>ypt1-2n0). differentially expressed genes between complete response and poor response will be analyzed. a scoring formula will be established based on the results. tumor tissue samples are collected before neoadjuvant therapy and will be analyzed via rna sequencing.

Eligibility criteria:
inclusion criteria: * histopathology proved to be adenocarcinoma of the rectum. * the edge of tumor is within 12cm of anus margin. * according to the eighth edition of ajcc tnm staging standard ,that staging for ⅱ-ⅲ period, as t3-t4, n0 or any t, n1-2. * there is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy. * understand and agree to sign the informed consent for the study. exclusion criteria: * with intestinal obstruction or impending obstruction, or perforation. * with other malignancies occurred within 5 years.
dermatitis herpetiformis refractory to gluten free diet

Conditions: Dermatitis Herpetiformis

Summary: the main purpose of the study is to find out 1. the natural course of refractory dermatitis herpetiformis and the development of possible complications 2. the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis

refractory dermatitis herpetiformis refers to dermatitis herpetiformis unresponsive to gluten-free diet therapy. so far, there is very little knowledge on the course of the disease and the causes and prognosis of refractory celiac disease. study patients with refractory dermatitis herpetiformis will be recruited. as a control material dermatitis herpetiformis patients with good response to gluten-free dietary treatment will be recruited.

Eligibility criteria:
inclusion criteria: study patients: * dermatitis herpetiformis diagnosis * dermatitis herpetiformis rash not responding to a strict gluten-free diet after at least 3 years control patients: * dermatitis herpetiformis diagnosis * dermatitis herpetiformis with good response to a gluten-free diet exclusion criteria: study patients: -not following strict gluten-free diet control patients: -not following a strict gluten-free diet

Keywords: dermatitis herpetiformis, dapsone, gluten-free diet
psychosocial risk factors for coronary heart disease in swedish women

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to study psychosocial risk factors for coronary heart disease in swedish women.

background: the incidence of non-fatal myocardial infarction in swedish women below age 60 increased during the past 20 years. standard risk factor change includes a decrease in average systolic blood pressure and s-cholesterol but a moderate increase in smoking and diabetes prevalence. during the same time period swedish women have 'moved' into the labor market, so that employment rates are now similar in swedish men and women. however, women have kept the main responsibilities for household and child care. in spite of generous legislation for maternity leave and child care, the strains from multiple roles and responsibilities have probably increased in swedish women. the study sought to provide an answer to: 1) which factors - biological and behavioral - influenced both the extent of and progress of coronary artery disease, 2) which physiological, biochemical, or neuroendocrine mechanisms participated in the process. in addition to conventional statistical methods, canonical correlations analyses were used to describe direct and indirect pathways of the pathogenesis. furthermore, by means of the two comparison groups, information was obtained about the specific characteristics of the female psychosocial and behavioral coronary heart disease risk profile. design narrative: the role of social strain was studied within a broader psychosocial context including social networks, social supports, social skills, reciprocity, coping, stressors, chronic work strain, family structure, personality and behavior characteristics. these aspects were related to possible physiologic cardiovascular mechanisms including reactivity of and persistent elevated heart rates and blood pressure on ambulatory monitoring as well as cardiac dysrhythmia and silent or symptomatic ischemia. psychoneuroendocrine pathways were also investigated. these included catecholamines, cortisol, prolactin, estrogen, testosterone, gastrin, somatostatin. other biochemical measures included lipid profile, coagulation, thrombolysis and immune function. these examinations were applied to all women below age 60, living in the greater stockholm area, with signs or symptoms of coronary heart disease. the women were followed and reexamined (including angiograms) after 2 to 2.5 years. they were compared to an equal number of age matched men and to an equal number of age matched healthy women from the same catchment area. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
the effect of cycling, running, and playing rugby on three biomarkers that may indicate brain injury

Conditions: Healthy Male and Female Subjects

Summary: the goal of this clinical trial was to determine if and how the biomarkers neurofilament light (nfl), brain lipid binding protein (blbp), and amyloid precursor protein (app) accumulated over 72 hours in venous blood following running, cycling, or playing rugby as compared to a non-exercising control group. participants in this study were recreationally active and healthy males and females 18 - 49 years of age. the main questions it aimed to answer was: do nfl, blbp, and app increase following exercise? researchers compared the accumulation of nfl, blbp, and nfl among runners, cyclists, rugby players, controls, and between sexes in each category. participants were asked to either run, bike, play a rugby match, or abstain from exercise. in the exercising group, blood was drawn from a vein prior to the activity, immediately after the activity, 30 minutes after the activity, 1 hour after the activity, 24 hours after the activity, 48 hours after the activity, and 72 hours after the activity. in the non-exercising group blood was drawn from a vein one time.

participants were recruited for this study from fall 2021 - spring 2022. participants recruited to play in a rugby match were current members of the university men's and women's club rugby team. running participants consisted of members of the university's men's and women's running teams as well as recreational runners. cycling participants consisted of members of the university's cycling club as well as recreational cyclists. male rugby athletes played two 40-minute halves while female rugby athletes played two 20-minute halves. these are typical match times for men's and women's rugby. runners were asked to run 6.44 kilometers at their own pace, and cyclists were asked to cycle 39 kilometers at their own pace. a control group comprised of both sedentary and recreationally active individuals was also recruited and asked to refrain from exercise for 24 hours. blood was drawn from an antecubital vein in the exercising groups before and after exercise as well as 30 minutes, 1-, 24-, 48-, and 72-hours after exercise. only one blood draw was taken in the control group. the blood biomarkers neurofilament light (nfl), brain lipid binding protein (blbp), and amyloid precursor protein were then measured in the venous blood and compared within groups, among groups, and between sexes.

Eligibility criteria:
inclusion criteria: * apparently healthy * those in the running group must be able to run 6.44 kilometers * those in the cycling group must be able to cycle 39 kilometers * those in the ruby group must be members of the university club rugby team exclusion criteria: * individuals with diabetes * individuals with heart disease * individuals who are pregnant * individuals who get light-headed or dizzy while donating blood

Keywords: brain injury biomarkers
evaluation of the cobas® 4800 hpv test for the detection of high-grade cervical disease

Conditions: Human Papilloma Virus (HPV)

Summary: this study provided data on the performance of the cobas® 4800 hpv test for identifying histologically confirmed high-grade cervical disease. the baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage (ecc) at baseline. these subjects included women with cytology that is 'not normal' and a selection of those with 'normal' cytology who entered a follow-up phase and underwent cytological evaluation annually for 3 years. in this follow-up phase, colposcopy and biopsy/ecc were performed only in women with cervical cytology considered 'not normal' at any of the annual follow-up visits.


Eligibility criteria:
inclusion criteria: * females ≥ 21 years of age presenting for routine cervical cancer screening. * an intact cervix. * willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study visit 1. exclusion criteria: * known pregnancy at study visit 1. * presenting for colposcopy at study visit 1. * any condition resulting in increased risk of bleeding at biopsy. * hysterectomy. * known history of ablative or excisional therapy to the cervix within the preceding 12 months.
quality control of ce-certified phonak hearing aids - sonova2018_05

Conditions: Hearing Loss, Sensorineural

Summary: phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the phonak hearing systems undergo a final quality control in terms of clinical trials. this is a validation study, investigating optimized algorithms, features, functions and wearing comfort. this will be a clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

in this study a comparison with a ce-labeled phonak receiver-in-the-canal (ric) device (active comparator) and two ce-labeled competitor devices (ric) is done. all study devices contain direct connectivity functionality which will be compared in terms of streamed audio quality, streaming stability and usability preferences of all available functions and features. this will be a clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years, mild to moderate hearing loss) without hearing aid experience * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * willingness to wear receiver in the canal hearing aids * informed consent as documented by signature * owning an iphone 6 or higher exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * known psychological problems * central hearing disorders
clinical usefulness of fractional flow reserve measurement for significant stenosis in proximal coronary artery

Conditions: Coronary Artery Disease; Stenosis

Summary: fractional flow reserve (ffr) is a pressure-wire-based index that is used during coronary angiography to assess the potential of a coronary stenosis to induce myocardial ischemia. recent esc guidelines referred to the usefulness of ffr extensively when noninvasive stress imaging is contraindicated, non-diagnostic, or unavailable. however, ffr requires additional manipulation with maximal and stable hyperemia by intravenous adenosine. more routine use of ffr for all angiographically significant stenoses would add considerable time, cost, and complexity to each pci procedure and might also increase the risk of catheter-related complications such as coronary dissection and perforation. although the guideline mentioned that ffr may not be useful in very high grade lesions (angiographically \>90%) which always have an ffr \ 70% diameter stenosis by visual estimation) and compare the angiographic parameters and ffr values in the study.


Eligibility criteria:
inclusion criteria: * patients ≥ 19 years old * typical angina * stable or unstable angina pectoris * at least one or more major epicardial coronary arteries with significant stenosis (\>70% diameter stenosis by visual estimation on angiogram) confined to the proximal portion of left anterior descending artery, left circumflex artery, or right coronary artery * reference vessel diameter of target lesion ≥3.0 mm * normal lv ejection fraction (≥50%) without wall motion abnormality by echocardiography exclusion criteria: * previous myocardial infarction * previous coronary bypass graft surgery * cardiogenic shock * multiple lesions in the vessel of interest * contraindication or hypersensitivity to adenosine or contrast media * reduced coronary blood flow (timi flow grade \<3) in the vessel of interest * heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions * pregnant women or women with potential childbearing * inability to understand or read the informed content
assessment of salivary biomarker levels in individuals with various periodontal diseases

Conditions: Periodontal Diseases

Summary: the aim of this study is to compare the salivary levels of hif-2 alpha, mmp-9, and trap-5b among healthy individuals, patients with gingivitis, and patients with periodontitis; to examine the relationship between these levels and clinical parameters; and to determine their effectiveness in distinguishing periodontal disease from a healthy condition. it will be evaluated whether these biochemical mediators can be used as diagnostic biomarkers in the diagnosis of periodontal disease. periodontal health is defined as the absence of signs of inflammation. gingivitis is an inflammation of the gums and, if left untreated, can progress to periodontitis, a more severe condition characterized by the destruction of the supporting structures of the teeth. in this destruction, the host immune response to bacterial products and various inflammatory mediators (cytokines, mmps) play a role. mmp-9 plays a significant role in the progression of inflammation and tissue damage. hif-2 alpha is a factor that regulates bone formation and resorption and is activated in hypoxic or inflammatory environments. trap-5b is a specific marker of osteoclast activity and bone resorption. in the literature, there is no study that evaluates these three biomarkers together in saliva samples in the context of periodontal disease. this study aims to investigate the changes in these salivary biomarkers in the presence of periodontal disease, their diagnostic potential, and their relationship with clinical parameters. the findings may also provide insights for future treatments targeting these cytokine pathways.


Eligibility criteria:
inclusion criteria: * systemically healthy (the identification of healthy volunteers will be based on patients' self-reported medical history; no additional diagnostic tests will be conducted.) * having at least twenty permanent teeth in the mouth * non-smoker * not on any continuous medication * no use of antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months * not pregnant or lactating * no periodontal treatment within the last 6 months * willing to participate in the study and having signed the "informed consent form" * between 18 and 70 years of age exclusion criteria: * having any oral or systemic disease * being on regular systemic medication * being pregnant or in the lactation period * having received periodontal treatment within the last 6 months * having used antibiotics, anti-inflammatory drugs, or systemic corticosteroids in the last 6 months * smoking * being under 18 years of age

Keywords: periodontitis gingivitis saliva hif-2a trap-5b mmp-9 elisa