Kornimate/medical-research-clean huggingface dataset:
influence of dietary fiber-rich meals on gene expression and postprandial glucose and lipid response

Conditions: Hypoglycemia; Hyperglycemia

Summary: the aim of this study is to * measure the effect on gene expression in leukocytes from a meal rich in oat bran * investigate the postprandial glucose, insulin and triglyceride responses after intake of meals containing fiber from different sources (oat, rye and sugar beet fiber) or a meal containing a mixture of these three fibers

dietary fiber has long been known to give beneficial health effects. yet, the understanding of how fiber-rich meals regulate molecular events at a gene level is limited. also, few studies have compared the effects of different fiber sources on postprandial responses and hardly any study the effects of fiber mixtures in the same meal, even though this is more similar to regular eating habits. healthy subjects will come to the study center after an overnight fast, to ingest breakfasts randomly enriched with different fiber. the meals contains either spray-dried oat drink, rye bran, sugar beet fiber a mixture of these three fibers, oat bran or no added fiber (control). all meals are adjusted to contain the same total amount of available carbohydrates and fat. blood leukocytes for gene expression profiling were taken before and 2 h after consumption while blood samples for analysis of postprandial glucose, insulin and triglyceride levels were taken every 30 min during 3 h. nugo affymetrix human genechip nugo_hs1a520180 are used for the microarray analysis and analysis is performed with linear mixed models and enrichment analysis to identify functional gene sets that responded to the specific oat bran effect.

Eligibility criteria:
inclusion criteria: * bmi 18-30 exclusion criteria: * pregnancy * breastfeeding * diabetes mellitus * hepatitis b * blood lipid lowering pharmaceuticals * intolerance or allergy to cereals or sugar beet fiber

Keywords: gene expression oats rye sugar beet fiber glucose insulin triglyceride decreased postprandial glucose decreased postprandial insulin glycemic index
efficacy of potassium sodium hydrogen citrate therapy on renal stone recurrence and/or residual fragments after shockwave lithotripsy and percutaneous nephrolithotomy in calcium oxalate urolithiasis

Conditions: Kidney Calculi

Summary: extracorporeal shock wave lithotripsy (eswl) and percutaneous nephrolithotomy (pcnl) become the therapy of choice for renal stone. although providing good results, stone recurrence is usually found as the therapies do not change the underlying metabolic abnormality. among the metabolic disorders, hypocitraturia is an important risk factor for calcium nephrolithiasis. this study evaluate the preventive effects of potassium sodium citrate on stone recurrence as well as stone growth post eswl or pcnl, in patients with calcium-containing stones.


Eligibility criteria:
inclusion criteria: * age \> 18 years * stone free or had residual calcium oxalate stone fragments with a less than 4 mm. diameter at eight weeks after eswl or pcnl exclusion criteria: * renal tubular obstruction * serum creatinine \> 2 mg/dl * urinary tract infection (bacteria \> 100,000 in urine culture) * hypersensitive or contraindication to potassium sodium hydrogen citrate * insertion double-j stent * history of arrhythmia, myocardial infarction or digitalis administration

Keywords: potassium sodium citrate stone recurrence eswl pcnl hypocitraturia intervention
evaluation of the optimal dose of gnrh agonist for triggering final oocyte maturation in high risk ohss patients

Conditions: Subfertility

Summary: the present study aims to investigate whether the dosage of the gnrh agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for ohss patients undergoing ovarian stimulation for ivf using gnrh antagonists and recombinant fsh.

three different doses of gnrh agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. the primary outcome measure will be the percentage of mature oocytes retrieved. secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles \>11mm in diameter on the day of triggering), fertilization rates and ohss occurrence. serum lh, fsh, e2, prg levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.

Eligibility criteria:
inclusion criteria: patients undergoing ovarian stimulation for ivf using gnrh antagonist protocol * age \< 40 years * anticipated high ovarian response exclusion criteria: * endometriosis \> than grade ii * one ovary

Keywords: gnrh agonist ohss triggering final oocyte maturation
immunological change and the single nucleotide polymorphism (snp) in children with irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome; Children

Summary: currently, the pathophysiology of irritable bowel syndrome( ibs) remains unclear . the purpose of this study is want to investigate the immunological changes in the children with ibs.

irritable bowel syndrome (ibs) is a highly prevalent functional gastrointestinal disorder.many children suffered from this disease and had impact on their daily life. however, the underlying pathophysiologic mechanisms remain to be elucidate. dysregulation of the gut immune system is considered an important pathophysiology. we want to investigate the immunological changes in the ibs children.

Eligibility criteria:
inclusion criteria: * (5-18y/o) with ibs, * all patients had chronic or relapsing symptoms of ibs consistent with the rome ii criteria exclusion criteria: * a history of psychologic disorders, probiotics, anti-inflammatory, analgesic, or immunosuppressive medication (nonsteroidal anti-inflammatory drugs, steroids) within the past 3 months were excluded

Keywords: immune
daylight-mediated photodynamic therapy of actinic keratoses:comparing 0.2%hal with 16%mal

Conditions: Actinic Keratoses

Summary: this pilot study compares two photosensitizers, hexylaminolaevulinate (hal) and methylaminolaevulinate (mal), in treatment of actinic keratoses. study is conducted using randomized split-face design. efficacy is assessed clinically, and histologically at 3 and 12 months. pain during and after treatments and adverse reactions at one week are recorded.

study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% mal) as photosensitizers (0.25mm-thick layer). a web-based validated program (research randomizer) generated a randomized list to define the treatment sides. the randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. illumination is performed using 2 hours daylight-exposure. efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. pain during and after treatments and adverse reactions at one week are recorded.

Eligibility criteria:
inclusion criteria: -symmetrical actinic damage on face or scalp exclusion criteria: * pregnancy * lactation * allergy to photosensitizer * photodermatose

Keywords: actinic keratoses daylight-pdt hexylaminolaevulinate hal methylaminolaevulinate mal hyperspectral imaging
provenge® (sipuleucel-t) active cellular immunotherapy treatment of metastatic prostate cancer after failing hormone therapy

Conditions: Prostate Cancer

Summary: provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them. having completed phase 1 and phase 2 clinical trials, provenge is now at the phase 3 level. one important phase 3 trial of provenge has been completed; the current trial is also a phase 3 study. if you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. there are two chances in three that you will receive provenge. after receiving treatment, you will be monitored at regular intervals until the study endpoints are met. at the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.

the trial is being conducted at multiple study centers throughout the united states. the trial is a double-blind, placebo-controlled trial. participants must meet specific eligibility criteria. study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center. if you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.

Eligibility criteria:
to qualify for this trial, you must have all of the following: * histologically documented adenocarcinoma of the prostate * cancer that has progressed while on adequate hormone therapy. this state of the disease is androgen independent prostate cancer (aipc). * cancer that has spread outside the prostate (metastatic) to lymph nodes or bone. please note that if your cancer has spread to organs (e.g., liver, lung, brain), you are not eligible for the study. * the absence of or minimal current cancer-related pain please note that there are additional eligibility criteria. the study center will determine if you meet all of the criteria. study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. you can then decide whether or not you wish to participate. if you do not qualify for the trial, study personnel will explain the reasons.

Keywords: prostate cancer prostate aipc androgen-independent androgen independent hormone insensitive hormone-insensitive psa prostatic adenocarcinoma hormone-refractory hormone refractory hrpc lhrh immune therapy immunotherapy vaccine dendritic cells antigen-presenting cells antigen presenting cells cancer vaccine therapeutic vaccine therapeutic cancer vaccine recombinant biological biopharmaceutical biotechnology biotech
fabry disease registry & pregnancy sub-registry

Conditions: Fabry Disease

Summary: the fabry registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with fabry disease, irrespective of treatment status. no experimental intervention is involved; patients in the registry undergo clinical assessments and receive care as determined by the patient's treating physician. the primary objectives of the registry are: * to enhance the understanding of the variability, progression, and natural history of fabry disease, including heterozygous females with the disease; * to assist the fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; * to characterize and describe the fabry population as a whole; * to evaluate the long-term safety and effectiveness of fabrazyme® fabry pregnancy sub-registry: this sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the fabry registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. data from the sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. no experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. if a patient consents to this sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.


Eligibility criteria:
inclusion criteria * fabry registry: all patients with a confirmed diagnosis of fabry disease who have signed the informed consent and patient authorization form(s) are eligible for inclusion. confirmed diagnosis is defined as a documented deficiency in plasma or leukocyte αgal (alpha-galactosidase) enzyme activity and/or mutation(s) in the gene coding for αgal. * fabry pregnancy sub-registry: * eligible women must: * be enrolled in the fabry registry. * be pregnant, or have been pregnant with appropriate medical documentation available. * provide a signed informed consent and authorization form(s) to participate in the sub-registry prior to any sub-registry-related data collection being performed. exclusion criteria fabry registry: there are no exclusion criteria. fabry pregnancy sub-registry: there are no exclusion criteria.

Keywords: alpha galactosidase a agal (alpha-galactosidase) fabry gl3 (globotriaosylceramide) anderson-fabry disease angiokeratomas gla deficiency (gene deficiency) errors in metabolism
randomized trial investigating melatonin supplementation vs placebo on sleep disturbance following total joint arthroplasty

Conditions: Sleep Disturbance; Total Joint Arthroplasty

Summary: the purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty


Eligibility criteria:
inclusion criteria: 1. patients who undergo unilateral primary total joint arthroplasty 2. patient willing and able to complete postoperative surveys exclusion criteria: 1. patients who undergo revision total joint arthroplasty 2. patients who undergo bilateral total joint arthroplasty 3. patients currently taking melatonin supplementation 4. patient has history of substance abuse (drug or alcohol) 5. patient is a workman's comp patient or patient has current litigation pending 6. patient has an allergy to melatonin 7. patient has a history of delirium/psychiatric/depression/on antidepressants 8. patient has a history of insomnia/ on sleep aid medication 9. anyone on warfarin 10. sleep apnea 11. patient discharged to snf or rehab 12. patients who have inflammatory conditions 13. shift work or night work
to evaluate the effect of azd3199 on the electrical activity in the heart

Conditions: Chronic Obstructive Pulmonary Disease; Lung Disease

Summary: the purpose of this research study is to evaluate the effect of azd3199 on the electrical activity of the heart. the effect of azd3199 will be compared to a licensed antibiotic (moxifloxacin). moxifloxacin effects on the electrical activity of the heart are well known. safety and tolerability of azd3199 and how much azd3199 enters the blood circulation will also be assessed.


Eligibility criteria:
inclusion criteria: * healthy male subjects aged 18 to 45 years (inclusive) * have a body mass index (bmi) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg. * be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start. * be able to inhale from the turbuhaler inhaler according to given instructions. exclusion criteria: * any clinically significant disease or disorder * any clinically relevant abnormal findings at screening examination * history of additional risk factors for torsade de pointes (eg, heart failure, hypokalaemia, or family history of long qt syndrome). * any clinically important abnormalities in rhythm, conduction or morphology of resting ecg that may interfere with the interpretation of qtc interval changes.

Keywords: respiratory disease bronchiolitis emphysema lung disease causing persistent narrowing of the airways
spontaneous regression in metastatic melanoma and renal cell carcinoma

Conditions: Melanoma; Renal Cell Carcinoma

Summary: the purpose of this study is to collect blood and clinical data from patients with metastatic melanoma and renal cell cancer who have experienced spontaneous regression for studies of immune response and other factors that may influence these occurrences.

spontaneous regression in patients with metastatic cancer is an incredibly rare event. it has been described after infection in cancer patients and also rarely in patients with renal cell cancer (usually after resection of the renal primary) and, less commonly, in patients with metastatic melanoma. primary objective to collect peripheral blood from patients with metastatic melanoma and renal cell cancer and spontaneous regression for studies of immune response and other studies. secondary objective to collect clinical data from subjects registered to this study. clinical data collection will include demographics and cancer characteristics, history and treatment.

Eligibility criteria:
inclusion criteria 1. ≥ 18 years old at the time of informed consent 2. ability to provide written informed consent and hipaa authorization 3. patients must have metastatic melanoma or renal cell cancer with spontaneous regression. 4. willingness to undergo phlebotomy for research blood samples exclusion criteria 1. concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety 2. dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Keywords: metastatic disease spontaneous regression
atrial fibrillation and premature atrial complexes in patients with ischemic stroke.

Conditions: Stroke; Atrial Fibrillation; Premature Atrial Complexes

Summary: the purpose of this study is to improve secondary prevention of ischemic stroke patients by 1. estimating prevalence and the prognostic significance of frequent premature atrial complexes in ischemic stroke patients in relation to death, recurrent stroke and atrial fibrillation. 2. characterize ischemic stroke patients by 1. echocardiographic characteristics 2. biochemical markers 3. plaque composition in the carotid arteries * in order to improve risk stratification.

patients with atrial fibrillation (af) have a five-fold increased risk of ischemic stroke compared to the general population. identifying af can be challenging, but prolonged rhythm monitoring of ischemic stroke patients have shown to enhance detection rates of af. therefore it is important to identify predictors of af to allow targeted screening of patients after ischemic stroke and thereby reduce the recurrent stroke rate. few former studies have shown an association between excessive numbers of premature atrial complexes (pacs) and af. the study population of ischemic stroke patients will at admission undergo following examinations: 1. ecg 2. 48 hours inpatient cardiac telemetry (if not known af) 3. 24 hours holter monitoring (if not known af) 4. echocardiogram 5. blood sample 6. ct scan of carotid arteries with contrast made on dual energy ct scan. in the follow-up period, patients will have two visits with 48 hour holter monitoring (after 6 and 12 months, respectively) it will be noticed if patients have any recurrent events, die og developing af. the study population will be divided into four groups as follows: 1. patients with new af at admission 2. patients with known af 3. patients with frequent pacs 4. patients without frequent pacs. these groups will be compared on baseline characteristics and on outcome as mentioned. the overall perspective is to make better strategies for detecting occult af after ischemic stroke to improve secondary stroke prevention care.

Eligibility criteria:
inclusion criteria: * admitted with ischemic stroke at a single center * time from diagnose to inclusion maximum 7 days. * written informed consent or surrogate informed consent eligible * age \> 18 years. exclusion criteria: * hemorrhagic stroke * terminal illness and expected lifespan of less than 6 months. * any physical or mental condition which make the patients unsuitable for participation in the study. * known with a pacemaker * anticoagulation treatment of other reasons than atrial fibrillation.

Keywords: stroke ischemic stroke cerebral infarction recurrent stroke atrial fibrillation premature atrial complexes heart rhythm monitoring left atrial function carotid artery plaque morphology
the evaluation of a nasal pillows mask for the treatment of obstructive sleep apnea (osa)

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: this investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

a minimum of 20 osa participants who currently use a nasal pillows mask will be recruited for the trial. participant will be on the trial for three weeks - first week will be a collection of positive airway pressure (pap) baseline data on the participant's usual mask. the participant will then use the trial mask in-home for 2 weeks. there is also an option of a two month extension if the participant wish to continue on the trial mask.

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give consent * apnea hypopnea index (ahi)≥ 5 on diagnostic night * prescribed pap for osa * existing nasal pillows user exclusion criteria: * inability to give consent * patients who are in a coma or a decreased level of consciousness * anatomical or physiological conditions making automatic positive airway pressure (apap) therapy inappropriate (e.g. unconsolidated facial structure) * commercial drivers who are investigated by new zealand transport agency * current diagnosis of carbon dioxide (co2) retention * pregnant or may think they are pregnant
cost- effectiveness study of brief interventions for mood and anxiety disorders

Conditions: Depressive Disorder; Anxiety Disorder

Summary: this study compares both clinical effectiveness and cost-effectiveness of a brief, intensified therapy and diagnostic method for patients with mood and/or anxiety disorders with treatment as usual (tau) at five outpatient mental healthcare centers in the netherlands.


Eligibility criteria:
inclusion criteria: * male of female adolescents * adolescents aged between 18 to 65 year * adolescents main complaint: mild to moderate anxiety and/or mood disorders with or without psychiatric and/or somatic co-morbidity * adolescents with proper understanding of the dutch language. exclusion criteria: * adolescents with current psychotic or bipolar traits, * adolescents with homicidal or suicidal risk * adolescents with severe social disfunctioning * no proper understanding of the dutch language