Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of salmeterol via handihaler® in healthy male volunteers

Conditions: Healthy

Summary: the objective of this study is to investigate if the systemic drug exposure of at least 25 μg and perhaps 50 μg salmeterol presented as inhalation powder in pe capsules and administered via handihaler® 2 does not exceed that of 50 μg serevent® diskus® and to investigate safety and tolerability of salmeterol presented as inhalation powder in pe capsules and administered via handihaler® 2


Eligibility criteria:
inclusion criteria: 1. healthy male based upon a complete medical history, including the physical examination, regarding vital signs ((blood pressure (bp), pulse rate (pr)), 12-lead ecg measurement, and clinical laboratory tests. there is no finding deviating from normal and of clinical relevance. there is no evidence of a clinically relevant concomitant disease. 2. age ≥21 and ≤50 years 3. bmi ≥18.5 and \<30 kg/m2 (body mass index) 4. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and the local legislation exclusion criteria: 1. any finding of the medical examination (including bp, pr, and ecg measurements) deviating from normal and of clinical relevance 2. evidence of a clinically relevant concomitant disease 3. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 4. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders 5. history of relevant orthostatic hypotension, fainting spells or blackouts 6. chronic or relevant acute infections 7. history of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator 8. intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomization 9. use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to randomization 10. participation in another trial with an investigational drug within 2 months prior to randomization 11. smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day) 12. inability to refrain from smoking on trial days as judged by the investigator 13. alcohol abuse (more than 60 g alcohol a day) 14. drug abuse 15. blood donation (more than 100 ml blood within 4 weeks prior to randomization or during the trial) 16. excessive physical activities within 1 week prior to randomization or during the trial 17. any laboratory value outside the reference range that is of clinical relevance 18. inability to comply with dietary regimen of the study centre the following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics: 19. asthma or history of pulmonary hyperreactivity 20. hyperthyrosis 21. allergic rhinitis in need of treatment 22. clinically relevant cardiac arrhythmia 23. paroxysmal tachycardia (\>100 beats per minute)
a study to assess the bioequivalence of famotidine/antacid combination tablets compared to famotidine/antacid ez chew tablets (0208c-145)(completed)

Conditions: Heartburn

Summary: a study in 24 healthy subjects to assess the bioequivalence of famotidine/antacid ez chew tablet taken without water and with water compared to the famotidine/antacid tablet taken with water. subjects will be given a single dose of each treatment separated by 5 to 7 days.


Eligibility criteria:
inclusion criteria: * female subject is not pregnant or lactating, females of childbearing potential must use reliable means of contraception during the course of the study * subject is in good health * subject is able to abstain from smoking during the 24-hour periods before and during each treatment day exclusion criteria: * subject has a history of stomach ulcers, other gastrointestinal (gi) diseases or gi surgery * subject has a history of asthma or severe allergies to drugs or foods * subject currently uses prescribed or nonprescribed drugs on a regular basis * subject has a recent history of drug/alcohol abuse * subject consumes more than 6 cups of coffee per day * subject has unconventional or extreme dietary habits * subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days * subject has a history of allergy or intolerance to antacids * female subject is known to be pregnant or is not using reliable means of contraception
omiganan twice a day (bid) in patients with facial seborrheic dermatitis

Conditions: Seborrheic Dermatitis

Summary: to explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis.


Eligibility criteria:
inclusion criteria: * male and female subjects with mild to moderate facial sd (iga 2 or 3), ≥18 years of age, inclusive. the health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than sd following a detailed medical history, a complete physical examination including vital signs, 12-lead ecg, hematology, blood chemistry, virology and urinalysis; * confirmed sd diagnosis by dermatologist * significant facial sd affected area as judged by the investigator or medically qualified designee * able to participate and willing to give written informed consent and to comply with the study restrictions; * willing to refrain from using other sd treatments in the local treatment area * subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose. exclusion criteria: * any current and / or recurrent clinical significant skin condition other than sd; * ongoing use of prohibited sd medication. washout periods prior to baseline are as follows; 1. topical steroids, antibiotics, antifungals or other topical (otc) therapies: 2 weeks 2. systemic steroids, antibiotics, antifungals or other systemic therapies: 4 weeks; 3. phototherapy: 3 weeks; 4. regular use of shampoo for the treatment of pc (including but not limited to otc zinc pyrithione shampoo), soap for the treatment of seborrheic dermatitis: 2 weeks 5. changing a soap, method for daily facial and hair washing: 1 week * known hypersensitivity to the compounds or excipients of the compounds; * tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment; * pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding; * participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year; * loss or donation of blood over 500 ml within three months (males) or four months (females) prior to screening.
hepcidin as a predictor for the ivi mediated increase in haemoglobin levels

Conditions: Anemia; IV Iron

Summary: the study is a multidisciplinary study, which involves all kind of medical specialties. patients, who are scheduled for elective surgery, will be seen at a multidisciplinary anaesthesia/patient blood management (pbm) clinic and screened for anaemia prior to surgery. anaemic patients will eventually be treated with 500mg of iron isomaltoside.

hgb levels, standard iron parameters and hepcidin will be assessed. additional parameters that might influence hgb or ivi levels will be documented. all main analyses will be pre-defined in detail in a statistical analysis plan. in order to analyse the responsiveness to ivi, the change in hgb levels from pbm clinic to day 0 will be analysed using multivariable regression models. the association of change in hgb and hepcidin will be analysed adjusting for potentially confounding factors as age, gender or number of days from pbm clinic to surgery. the correlation of hepcidin and standard iron parameters will be assessed. based on the increase in hgb levels, responders to ivi will be defined. the definition of good- bad responder in terms of delta hgb levels depends on the time between ivi substitution and surgery. roc analyses will be performed and potential predictors (e.g. hepcidin, ferritin) will be compared concerning the area under the roc curve (auc).

Eligibility criteria:
inclusion criteria: * informed consent * iron deficiency anemia * elective surgery planned during the next 4 to 28 days exclusion criteria: * contraindications for an iv iron infusion severe infections, hepatocellular carcinoma, liver metastases, acute severe asthma, a simultaneous oral iron medication, another iv iron preparation, iron overload, chronic renal failure and regular iv iron substitution * pregnancy or lactation * allergy against iron * chronic renal failure on dialysis * iron overload

Keywords: hemoglobin hepcidin
study with a topical gel to treat common warts in adults

Conditions: Warts

Summary: the primary purpose of this study is to evaluate the effectiveness in adults of 2 different strengths of resiquimod gel applied to common wart(s) five times a week for up to 12 weeks. a second purpose is to evaluate the safety of the drug.


Eligibility criteria:
inclusion criteria: * diagnosis of common warts * two forms of birth control exclusion criteria: * pregnant or breast feeding * other types of warts, ie. plantar * currently participating in another clinical study * chronic viral hepatitis b or c

Keywords: warts adults common warts resiquimod
octreotide therapy in children and young adults with prader-willi syndrome (pws)

Conditions: Prader-Willi Syndrome

Summary: the purpose of this study is to investigate over a 6 month period the effect of octreotide therapy on food intake, sense of hunger, body weight, body composition, efficiency of burning calories, biomarkers of weight regulation and growth hormone markers in children and young adults with prader-willi syndrome(pws).

obesity continues to be a prevalent health concern affecting every race of the american population. according to data from the world health organization, 54% of u.s. adults are overweight (body mass index (bmi) \>25 kg/m2 ) and 22% are obese (bmi \>30 kg/m2) (1). in addition, 25% of u.s. children are overweight or obese (1). studies show that obese children are likely to become obese adults (2-5). also, recent studies report significant years of life lost due to the impact of being an obese adult (6, 7). thus, insights into the pathogenesis of childhood obesity and preventative measures are needed to combat the inevitable increase in worldwide incidence of obesity and its associated co-morbidities. recent studies have identified a new gastroenteric hormone, ghrelin, as a long-term regulator of energy balance in humans (12). ghrelin is a 28 amino acid acylated peptide which is an endogenous ligand of the growth hormone secretagogue receptor (ghs-r), a hypothalamic g-protein-coupled receptor (13). enteroendocrine cells (x/a-like cells) of the stomach are the major site of ghrelin synthesis, although a minor proportion of ghrelin synthesis occurs in other sites such as the hypothalamus, pituitary, duodenum, jejunum and lung (14) (15, 16). the hypothesis that hyperghrelinemia causes some of the features of pws predicts that this disorder will be ameliorated (partially or completely) by lowering ghrelin levels. we have recently shown that the somatostatin agonist, octreotide, suppresses ghrelin levels in humans. if octreotide remains effective in longer term studies, the drug may become an adjuvant therapy, in addition to growth hormone, to control the insatiable appetite and morbid obesity seen in this condition.

Eligibility criteria:
inclusion criteria: * diagnosis of pws confirmed by chromosome analysis * ages 5 years to 21 years * bmi for age ≥ (greater-than or equal to)85th percentile * written informed consent and assent obtained and willingness to comply with the study schedule and procedures * free t4, thyroid stimulating hormone (tsh) values in the normal range (either endogenous or with thyroxine replacement) exclusion criteria: * patients with any other clinically significant disease that would have an impact on body composition, including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders * concomitant use of an investigational drug or octreotide in the past year * use of steroids for longer than 7 days within the past 30 days

Keywords: childhood obesity prader-willi syndrome octreotide ghrelin weight loss body composition energy expenditure
ketone pharmacokinetic study in hfref

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called sglt2 inhibitors. the research team is trying to determine the safest dose of delta g. the study has a single visit. participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. the study team will draw blood intravenously up to eight times over the course of the half-day visit.


Eligibility criteria:
inclusion criteria: * diagnosis of hfref (ejection fraction\<=45%) * systolic blood pressure greater \>=90 mmhg exclusion criteria: * intentional ketogenic (high fat, low carbohydrate) diet (must be off ketogenic diet for \>7 days prior to visit) * significant liver disease (cirrhosis) or alcohol abuse disorder (\>14 drinks/week). * unique cardiomyopathies: infiltrative/hypertrophic cardiomyopathy, pericardial disease, or other cardiomyopathies that in the investigator's opinion have unique treatment options that would be less likely to be affected by ketone therapy. * estimated glomerular filtration rate\<25 ml/min/1.73 m2 as the most recent value in the last year. * type 1 diabetes mellitus * use of ventricular assist device, history of heart transplant, or use of continuous inotropes * pregnant women. due to unknown affects of nutritional ketosis in pregnant women, pregnancy will be an exclusion. accordingly, women of childbearing age with a menstrual cycle within the past year will be asked to submit a urine specimen for pregnancy testing.

Keywords: deltag ketone ester metabolites metabolomics ketoacidosis
conventional endoscopic techniques versus endorotor® system for necrosectomy of walled of necrosis

Conditions: Acute Pancreatitis; Necrosis; Pancreas, Acute (Infectious)

Summary: in acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (won) encapsulates the collection. to date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (vard) or endoscopic ultrasound (eus) guided drainage followed by direct endoscopic necrosectomy (den). different den techniques are available for the treatment of won, however, there is a lack of effective endoscopic instruments to perform den. recently, the first dedicated alternative to conventional den has been cleared for use, namely the endorotor® resection system. this device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during den for won. previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay. therefore, aim of this study is to assess the performance of the endorotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (den) of walled off necrosis (won) in a randomized controlled trial.


Eligibility criteria:
inclusion criteria: * patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone eus-guided drainage. a. stent must be in place for a minimum of 2 days prior to the den procedure. * patients who can tolerate repeat endoscopic procedures. * subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments. * asa classification \< 5. exclusion criteria: * documented pseudoaneurysm \> 1 cm within the won. * subject unable or unwilling to provide informed consent. * intervening gastric varices or unavoidable blood vessels within the won access tract (visible using endoscopy or endoscopic ultrasound). * coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed). * any condition that in the opinion of the investigator would create an unsafe clinical situation or stent placement that would not allow the patient to safely undergo an endoscopic procedure. * pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the investigator, and/or are not willing to use reliable contraception for the duration of study participation. * patient is enrolled in another trial that could interfere with the endpoint analyses of this trial. * prior necrosectomy on existing collection. * greater than 2 pancreatic / extra-pancreatic fluid collections.
multi-delay arterial spin labeling application in acute ischemic stroke

Conditions: Stroke

Summary: this study explores the value of the non-invasive quantitative evaluation system for cerebral blood flow perfusion function in the diagnosis of stroke. compared with traditional perfusion techniques, multi-delay arterial spin labeling (asl) is validated to determine the accuracy of perfusion level, ischemic penumbra and other indexes in patients with acute ischemic stroke. the relationship between perfusion levels of md-asl parameters and clinical outcome is also studied.

a total of 200 patients with acute anterior circulation ischemic stroke will be prospectively enrolled. all patients underwent ctp, multi-delay asl, dwi, cta or tof-mra scanning. cbf, cbv, mtt and tmax will be obtained based on ctp, and the range of reversible cerebral ischemia injury will be calculated based on dwi and ctp data. cbf, cbv and att images will be obtained based on the multi-delay asl, and the calculated results of reversible cerebral ischemia injury will also be obtained. meanwhile, the image quality of ctp and multi-delay asl will be evaluated. the time from the patient to the completion of imaging examination and the imaging examination time will be recorded. mann-whitney u test and t test can be used to compare the difference of assessment time between different test methods. chi-square test can be used to compare the differences of image quality among different examination methods. wilcoxon rank sum test can be used to evaluate the difference between ctp and multi-delay asl in terms of parameters and volume of reversible ischemic injury.

Eligibility criteria:
inclusion criteria: 1. ischemic stroke within 24h； 2. anterior circulation occlusion confirmed by conventional angiography or magnetic resonance angiography； exclusion criteria: 1. pregnancy and other contraindication to mri scan； 2. informed consent not obtained.

Keywords: ischemic stroke magnetic resonance imaging cerebrovascular disease
evaluation of the efficacy and safety of microneedling combined with botulinum toxin-a versus meso-botox injection in the treatment of atrophic acne scars: a split-face comparative study

Conditions: Atrophic Acne Scar

Summary: post-acne scars are psychologically disappointing and therapeutically challenging condition. no standard treatment for atrophic acne scars. micro-botox, is a highly diluted btx-a which could be injected safely intra-dermally. it targets the superficial fibers of facial muscles, sweat, and sebaceous glands inducing pores shrinkage, decreasing the sebum and excessive sweating, in addition to face lifting and reducing fine wrinkles without affecting emotions, this subsequently makes the skin tighter and gives the facial skin a smooth appearance. also, btx-a appears to have an inhibitory effect on fibroblasts and collagen remodeling activity, in addition to releasing muscular tension at scar edges through superficial muscle relaxation. so, it can reduce the tethering and pulling effect of the muscles surrounding the acne scars. also, it has anti-inflammatory and angiogenesis induction effects. therefore, micro-botox is believed to improve acne scars. therefore, it will be interesting to compare the efficacy and safety of microneedling combined with btx-a versus meso-botox injection in the treatment of atrophic acne scars through a split-face clinical study.


Eligibility criteria:
inclusion criteria: * patients with atrophic post-acne scars. exclusion criteria: * pregnancy and lactation. ongoing infection within the targeted treatment region or active acne lesions. skin cancer, or precancerous lesions. history of keloid formation. history of allergy to btx. patients with neuromuscular diseases, patients with pre-existing medical conditions that cause muscle weakness as myasthenia gravis. patients who underwent botox injection, during the last 6 months. patients who were under treatment by systemic retinoids in the previous 6 months. patients with a history of chemical peels or laser procedures within 6 months of the study period. patients with bleeding disorders.
uganda sickle surveillance study (us-3)

Conditions: Sickle Cell Disease

Summary: it is estimated that over 250,000 babies are born with sickle cell disease (scd) annually in sub-saharan africa, and only 10% - 50% of them survive beyond five years of age. data describing the magnitude of the sickle cell problem are lacking in most african countries. the available data on prevalence were mainly from older studies and small numbers of hospitalized patients. in uganda, approximately 25,000 children are born with scd but 70-80% die before their 5th birthday. lehmann and raper found 'sicklaemia' prevalence of 0.8% and 45% in the sebei and bambaa ethnic groups, respectively. a recent study found a sct and scd prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. the objective of this study is to determine the prevalence and map out the burden of sct and scd in uganda.

the investigators propose a cross-sectional study of sickle cell trait (sct) and disease in all districts of uganda using dried blood spots (dbs) collected from hiv exposed babies over a 12-month period. about 90,000 dbs samples collected from hiv exposed children from all districts of uganda from february 2014 to march 2015 will be analyzed. follow-up analysis will occur on up to 1,000,000 samples collected during 2015 - 2030 based on surveillance findings and secondary objectives. the study will be conducted at the central public health (cphl) in kampala where the samples from across the country are collected for pcr testing. the investigators will perform hemoglobin analysis using isoelectric focusing (ief). the overall prevalence and the prevalence by district of sct and scd will be determined. geospatial mapping will be performed using a specialized software program to produce a map illustrating the prevalence of sct and scd throughout the country and allow associations between sickle cell trait/disease with either malaria prevalence or hiv co-morbidity. further analysis of sickle cell disease or hemoglobin variants will be conducted using hplc and dna-based techniques.

Eligibility criteria:
inclusion criteria: * up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings. exclusion criteria: * repeat samples on the same individuals during the study period will be excluded.