Kornimate/medical-research-clean huggingface dataset:
a study to assess pharmacokinetics and pharmacodynamics following administration of bay1093884 in patients with severe hemophilia

Conditions: Hemophilia A; Hemophilia B

Summary: the primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia. the secondary objective is to assess the pharmacodynamics of bay1093884 based on tissue factor pathway inhibitor activity


Eligibility criteria:
inclusion criteria: * males with severe congenital hemophilia a or b defined as \<1% fviii or \<2% fix concentration by measurement at the time of screening or from reliable prior documentation (e.g., measurement in other clinical bayer trials, or diagnostic genetic testing) * male with any inhibitor titer at screening or prior to screening at any time from medical records. subjects may be receiving a bypassing agent (rfviia; novoseven and/or apcc; feiba) for treatment. * age: 18 to 65 years at screening * bmi: 18 to 29.9 kg/m2 exclusion criteria: * subjects with known bleeding disorders (such as von willebrand factor \[vwf\] deficiency, fxi deficiency, platelet disorders, or known acquired or inherited thrombophilia etc.) other than congenital hemophilia a or b with or without inhibitors * history of angina pectoris or treatment for angina pectoris * history of coronary and/or peripheral atherosclerotic disease, congestive heart failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (sbp) ≥160 mmhg or diastolic blood pressure (dbp) ≥100 mmhg even if controlled * history of thrombophlebitis, venous/arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, cerebrovascular accident, ischemic heart disease, transient ischemic attack) * known or suspected hypersensitivity of the immune system, history of anaphylactic reaction, known severe allergies, non-allergic drug reactions, or multiple drug allergies * subjects with inhibitors treated with feiba, who are not willing to accept rfviia (novoseven) for the treatment of any bleeds occurring either between screening and dosing or after study drug administration, and until the end of the study.
presentation and outcomes of acute appendicitis during covid pandemic

Conditions: Acute Appendicitis

Summary: acute appendicitis (aa) is a frequent cause of acute abdominal pain in emergency rooms around the world \[1\]. the lifetime risk of developing aa is estimated to be about 8% \[1-3\]. the severe acute respiratory syndrome sars-cov-2 coronavirus (covid-19) pandemic has raised difficult situations for healthcare systems and organizations around the world, with direct and indirect implications for patient care delivery. covid-19 causes a wide range of clinical symptoms, including fever, dry cough, myalgia, and exhaustion, with pulmonary involvement in many cases. according to the world health organization (who), the effect of the covid-19 pandemic on acute appendicitis and surgical care is unknown due to a lack of evidence. to see how appendicitis care has changed as a result of the covid-19 pandemic, this study compares clinical presentation, investigative modalities, treatment procedures, and outcomes before and after the pandemic.

acute appendicitis (aa) is a frequent cause of acute abdominal pain in emergency rooms around the world \[1\]. the lifetime risk of developing aa is estimated to be about 8% \[1-3\]. the sars-cov-2 coronavirus (covid-19) pandemic has raised difficult situations for healthcare systems and organizations around the world, with direct and indirect implications for patient care delivery. covid-19 causes a wide range of clinical symptoms, including fever, dry cough, myalgia, and exhaustion, with pulmonary involvement in many cases. according to the world health organization (who), the effect of the covid-19 pandemic on acute appendicitis and surgical care is unknown due to a lack of evidence. to see how appendicitis care has changed as a result of the covid-19 pandemic, this study compares clinical presentation, investigative modalities, treatment procedures, and outcomes before and after the pandemic. this is a multicenter prospective cohort study that was conducted for patients presented with acute appendicitis (aa).

Eligibility criteria:
inclusion criteria: patients with acute appendicitis exclusion criteria: * patients with acute appendicitis less than 12 years * malignant appendix
single dose of dexamethasone in femur fractures

Conditions: Fractured Neck of Femur

Summary: fracture neck of femur is a common cause of hospital admission in the elderly and requires operative fixation. dexamethasone has the potential of inhibiting cortisol secretion. in addition, preoperative glucocorticoids improve analgesia and decrease opioid consumption with reduction in associated side effects in a variety of clinical settings. the investigators hypothesis was that a single dose of preoperative dexamethasone enhance postoperative analgesia and attenuates the inflammatory response in patients undergoing operative fixation of fractured neck of femur, in a prospective, randomized, placebo controled trial.

having obtained ethical approval and written informed consent from each, 40 patients scheduled to undergo operative fixation of fractured neck of femur will be randomized using sealed envelopes to two groups. patients in the dexamethasone group receive a single dose of 0.1 mg/kg dexamethasone iv. preoperative, patients in the placebo group receive the same amount of normal saline. the anaesthetic technique is standardized, salive samples, blood samples are taken and pain scores are measured on a visual analog scale postoperatively at several timepoints.

Eligibility criteria:
inclusion criteria: * above 65 years * asa i-iii patients exclusion criteria: * patient refusal * outside age range * coagulation disorders * depression * cushing syndrome * endocrine disorders * corticosteroid treatment in the last 4 month * head injury or associated injuries * mini mental scores \< 25

Keywords: fractured neck of femur dexamethasone
cell-free dna methylation for epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer; DNA Methylation; Benign Ovarian Tumor; Training Set; Validation Set; Cell-free DNA; Liquid Biopsy

Summary: liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (eoc). in this study, we performed the methylation testing of host dna, namely, opcml, fodx3 and cdh13, in the peripheral serum to discover the diagnostic and supervision roles of dna methylation in eoc patients. the study compromises two stages. in the training set, dna methylation testing is performed in the ovarian tissues from eoc and paired benign ovarian tumor patients. the cut-off values of methylation are produced in this stage. on the meantime, serum dna methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues. in the validation set, serum dna methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors. in training and validation sets, serum dna methylation is also performed after major surgeries for eoc as to illustrate the changes of methylation testing, therefore, reflection the supervision role of dna methylation.


Eligibility criteria:
inclusion criteria: * with definite histological diagnosis of epithelial ovarian cancer and paired benign ovarian tumor in training set, and with definite histological diagnosis of ovarian tumor in validation set. * with sufficient fresh peripheral serum and ovarian samples for dna methylation testing before with or without after major surgeries. * aged 18 years or older. * signed an approved informed consents exclusion criteria: * not meeting all of the inclusion criteria.
efficacy of a low fodmap diet according to colonic ph in irritable bowel syndrome patients

Conditions: Irritable Bowel Syndrome

Summary: treatments efficacy in irritable bowel syndrome (ibs) patients is inconstant and predictive factors of their efficacy are needed. the role of dysbiosis in ibs is well-known. another way to identify microbiota differences is to assess its metabolic activity. it has been demonstrated that colonic ph in ibs patients is lower than in healthy volunteers, reflecting a highest colonic fermentation. colonic acidification is able to sensitize colonic mechano-receptors to distension. microbiota profile is able to predict the response to a low fermentable oligo, di, monosaccharides and polyols (fodmaps) diet, but is not available in clinical routine. the aim of our study is to assess the link between colonic fermentation (measured by colonic ph) and the efficacy of a low fodmaps diet in ibs patients (measured by ibs severity scoring system (ibs-sss)). we hypothesis that ibs patients with a lower colonic ph will have a better efficacy of the low fodmaps diet. it might allow in the future personalized medicine. 50 ibs patients according to rome iv criteria will be included in our study. all patients will have a measure of their colonic ph by wireless motility capsule. patients will follow a low fodmaps diet for 6 weeks after an education by a trained dietician. all participants will fill validated questionnaires before and after 6 weeks of low fodmaps diet: ibs-sss, gastro intestinal quality of life index (giqli), hospital anxiety and depression (had) scale. microbiota, metabolomic and short chain fatty acid will be analysed before and after the intervention. the number of patients was calculated to assess the correlation between colonic ph and the variation of ibs-sss before and after the intervention.


Eligibility criteria:
inclusion criteria: * ibs according to rome iv criteria * normal blood test (cell blood count, c reactive protein, thyroid-stimulating hormone, anti transglutaminase antibodies) in the last 12 months * ibs severity score (ibs-sss) \>175/500 * ibs treatments stable in the last month * effective contraception since 1 month for women in childbearing age exclusion criteria: * anorexia nervosa or any eating disorders deemed incompatible * organic gastroenterological diseases (inflammatory bowel disorder, microscopic colitis, gastrointestinal cancer, celiac disease) * contra-indication to the wireless motility capsule (intestinal stenosis, digestive fistula or obstruction, history of bezoar, gastrointestinal surgery in the last 3 months, acute diverticulitis, cardiac pacemaker, implanted electromedical device, magnetic resonance imaging planned in the 5 days after the wireless motility capsule, swallowing disorder) * breastfeeding or pregnant women * participation in another clinical trial in the last 2 weeks * patient who could not stop proton pump inhibitor treatment for 10 days * person with administrative or judicial decision or under legal protection measure

Keywords: low fodmap diet predictive factor colonic ph
canadian pulmonary embolism diagnosis study (canpeds)

Conditions: Suspected Pulmonary Embolism; Deep Venous Thrombosis

Summary: the main objective of the trial is to determine whether d-dimer testing combined with assessment of pre-test-probability (using a standardized clinical model) can be used to markedly simplify the diagnostic process for pe. it may be safe to omit additional diagnostic testing in selected patients with suspected pulmonary embolism who have a negative d-dimer test

to assess the value of the d-dimer in the diagnosis of pe, we had two sub-groups of patients with suspected pe, low and high pre-test probability. patients could be randomized either to further or no further testing.

Eligibility criteria:
inclusion criteria: * patients with clinically suspected pe exclusion criteria: * treatment with anticoagulants for greater than 24 hours of performance of d-d * comorbid condition limiting survival to less than 3 months * absence of acute symptoms within 7 days prior to presentation * current pregnancy * contraindication to contrast (e.g., allergy, renal failure) * geographic inaccessibility which precludes follow-up * physician believes patient is inappropriate for study * failure or inability to provide informed consent

Keywords: pulmonary embolism dvt venous thrombosis d dimer dd thrombosis diagnosis
safety and tolerance study of grass pollen-derived peptides to treat allergic rhinitis

Conditions: Seasonal Allergic Rhinoconjunctivitis

Summary: the purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.


Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * the subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status * male or non-pregnant, non-lactating females * a history of seasonal allergic rhinoconjunctivitis (sar) during the grass pollen season during at least the last two years * a positive skin prick test to grass-pollen mixture * specific ige against grass pollen (rast class 2 or ige \> 0.7 ku/l) * asymptomatic to perennial inhalant allergens exclusion criteria: * subjects with current or past immunotherapy for sar * subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) * documented evidence of acute or significant chronic sinusitis (as determined by individual investigator) * subjects with a history of food allergy and consecutive anaphylaxis * subjects with a history of hepatic or renal disease * subject with malignant disease, autoimmune disease * female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (ocs, iud). * females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal \[defined as a minimum of one year since the last menstrual period\]) * any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc...) * subjects with clinically relevant abnormal qtc intervals of the ecg : qtc \> 450 ms for man and \> 470 ms for women * subjects requiring beta-blockers medication * chronic use of concomitant medications that would affect assessment of the effectiveness of the study medication (e.g. tricyclic antidepressants) * subject with febrile illness (\> 37.5°c, oral) * a known positive serology for hiv-1/2, hbs antigen or anti-hcv antibodies * the subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry * receipt of blood or a blood derivative in the past 6 months preceding study entry * regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the study, any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the study * use of long-acting antihistamines * any condition which could be incompatible with protocol understanding and compliance * subjects who have forfeited their freedom by administrative or legal award or who are under guardianship, * participation in another clinical trial and/or treatment with an experimental drug within 1 month of study start * a history of hypersensitivity to the excipients
azithromycin for preventing maternal and neonatal infections during labor.

Conditions: Maternal and Neonatal Sepsis; Intrapartum Antibiotics

Summary: in this study, we want to see the role of the antibiotic, azithromycin, in preventing maternal and neonatal infections, if the drug is given intrapartum to the mother


Eligibility criteria:
inclusion criteria: * pregnant ladies with no risk factors for sepsis who go into spontaneous labor or induced labor exclusion criteria: * pregnant with risk factors for sepsis like maternal fever , raised wbc count, chorioamnionitis, or having. history of any adverse even with macrolides
biomarker in lung diseases

Conditions: Lung Diseases

Summary: disease related biomarkers have been established decades ago, e.g. blood glucose for diabetes diagnosis and management. their discovery has grown dramatically during the past decade and they have the potential to lead the physician in diagnosis -especially differential diagnosis - and therapy. however, a specific serum-biomarker in lung diseases has not been established. aim of the current study is to to measure lung specific proteins in the serum in patients with various lung diseases and to correlate those with disease severity, lung function and other laboratory results


Eligibility criteria:
inclusion criteria: * age \>= 18 * acute or chronic lung disease exclusion criteria: * hiv * lactation or gestation

Keywords: biomarker lung disease
a prevalence study of obstructive sleep apnea in subjects with chest pain, positive exercise treadmill test and normal coronary angiogram

Conditions: Obstructive Sleep Apnea; Cardiac Syndrome X; Endothelial Dysfunction

Summary: cardiac syndrome x consists of a triad of chest pain, abnormal exercise stress testing and normal coronary angiogram, and is hypothesized to be related to endothelial dysfunction. endothelial dysfunction is also reported to be linked to obstructive sleep apnea. while chest pain can be one of potential presenting symptoms of obstructive sleep apnea, the investigators hypothesize that obstructive sleep apnea is common in subjects with cardiac syndrome x.


Eligibility criteria:
inclusion criteria: * age ≧18 years, \< 70 years * symptom of chest pain occurring at least once in the preceding year * positive exercise treadmill test * negative coronary angiogram * mentally fit to give informed consent exclusion criteria: * mentally incapacitated persons * congestive heart failure * other potential causes of orthopnea (severe chronic obstructive pulmonary disease, persistent asthma)
influence of rodenstock spectacle lenses on myopia progression.

Conditions: Myopia

Summary: the prevalence of myopia in singapore is among the highest in the world, with 65 percent of our children being myopic by primary 6, and 83 percent of young adults being myopic. as such, singapore is often labelled as the "myopia capital of the world". by 2050, it is projected that 80 to 90 per cent of all singaporean adults above 18 years old will be myopic and 15 to 25 percent of these individuals may have high myopia. high myopia (spherical equivalent refraction ≤ -5 d) puts one at risk of many eye disorders later in life, such as early cataracts, glaucoma and macular degeneration. these complications often cause significant morbidity and may even be sight-threatening. hence there is an urgent and growing need for synergistic efforts to counter myopia. the goal of this clinical trial is to test the efficacy of spectacle lenses in controlling the progression of myopia in children (aged 6-12 years) over a period of 2 years. in addition, this trial aims to evaluate the impact of these spectacle lenses on central visual performance and visual comfort. therefore, in this randomised, double-masked clinical trial, one hundred and eighty-five (n=185) subjects aged 6-12 years with mild or moderate myopia (\< -5d) will be randomised in a 1:1 allocation ratio into three strata defined by age 6-8, 8-10 and 10-12 years to ensure age balance between the two arms (control group - single vision lenses and intervention group - myopia control lenses, gender matched). in the control group, after one year (12 months) of wearing single vision lenses, the children will switch to the myopia control lenses (crossover design).


Eligibility criteria:
inclusion criteria: * all myopic children aged 6-12 years old * treatment naïve * sphere: -0.5 d till -6.00 d * anisometropia \< 1.5d * astigmatism \> -1.5d * monocular best corrected visual acuity +0.1 logmar or better, and binocular visual acuity 0.0 logmar or better exclusion criteria: * on current myopia control treatments * any diagnosed ocular conditions besides myopia or astigmatism. * no diagnosed ocularmotor conditions (nystagmus, strabismus, etc.) * any diagnosed chronic physical or mental disabilities * contraindication in cycloplegia (high iop, etc.) * corneal astigmatism \> 1.5 d; irregular astigmatism

Keywords: myopia myopia control lenses light
behavioral and pharmacological treatment for insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: this study will evaluate the long- and short-term effects of cognitive-behavior therapy (cbt), alone and in combination with zolpidem (ambien®), for chronic insomnia.

insomnia is a prevalent health concern which is often associated with functional impairments, reduced quality of life, and increased health-care costs. the proposed study may provide useful information about optimal models for integrating behavioral and pharmacological therapies for the clinical management of insomnia. participants are randomly assigned to cbt or cbt plus medication. after the 6-week acute treatment phase, participants enter into a 6-month extended treatment phase. of those treated with cbt alone initially, responders are randomized to extended cbt or no treatment. of those receiving the combined cbt plus medication approach initially, responders are randomized to an extended treatment consisting of either cbt plus medication (used on an as needed schedule) or cbt alone (plus medication tapering). outcome is evaluated across measures of sleep, clinical ratings, and several indices of daytime functioning. the measures are administered at baseline, at the end of the acute and extended treatment phases, and at 6, 12, and 24-month follow-up.

Eligibility criteria:
inclusion criteria: * subjective complaint of difficulties initiating or maintaining sleep, accompanied by marked distress or daytime impairments due to insomnia * sleep difficulties present 3 nights or more per week and lasting for more than 6 months exclusion criteria: * major medical or psychiatric problems

Keywords: insomnia sleep disorders sleep deprivation
managing asthma and obesity related symptoms (matadors) feasibility study

Conditions: Asthma in Children; Obesity; Obesity, Adolescent; Obesity, Childhood

Summary: the purpose of this 4 week pilot study is to test the use of a mobile application (also commonly referred to as an app) designed to help increase self-management strategies among youth that have asthma and obesity. the data obtained from this study will facilitate refinement of the app and interventional approaches for a future larger scale study to increase youth self-management of their clinical conditions, symptom management, and health maintenance as they transition to adulthood.


Eligibility criteria:
inclusion criteria: * youth-caregiver dyad inclusion criteria: * male and female youth aged 10 - 17 years * adult primary caregiver (18 years and older) * english speaking * youth diagnosis of asthma * prescribed inhaler treatment for asthma * youth body mass index at or above the 85th percentile for age and sex based on the centers for disease control (cdc) growth charts * must own a smartphone (ios) with working wi-fi access and/or cellular data plan * prescribed inhaler treatment for asthma exclusion criteria: * diagnosis of cognitive impairment * inability or unwillingness of youth participant to assent and/or primary caregiver/legal guardian/representative to give informed consent * inability or unwillingness to participate in the audio recording interview session or complete study procedures