Kornimate/medical-research-clean huggingface dataset:
effect of pyridorin in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the primary objective of the study is to evaluate the safety, tolerability and efficacy of pyridorin (pyridoxamine dihydrochloride) up to 250 mg given orally twice daily in patients with diabetic kidney disease.


Eligibility criteria:
inclusion criteria: * males and females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes * sitting blood pressure of \<=170/100 mm hg at weeks -2 and -1 * hemoglobin a1c \<=12% at week -2 * patients with diagnosis of diabetic nephropathy as defined by 1. serum creatinine \ 2.0 mg/dl but \<=3.5 mg/dl at weeks -2 and -1 (pyr-207) 2. urinary albumin excretion \>=300 mg/24 hours at week -2 3. no other known or suspected etiology for nephropathy * voluntary written consent to participate in this study exclusion criteria: * history of allergic or adverse response to any b vitamin * history of major cardiovascular or cerebrovascular events * history of cancer except adequately treated basal or squamous cell carcinoma of the skin * history of diabetic ketoacidosis * autoimmune diseases * history of significant peripheral neuropathy

Keywords: diabetic nephropathy advanced glycation endproduct inhibitor pyridorin pyridoxamine
effect of ldl-apheresis on ptx3 plasma levels in hypercholesterolemic patients

Conditions: Hypercholesterolemia

Summary: inflammation plays a major role in atherosclerosis. pentraxin 3 (ptx3) a multifunctional pattern-recognition protein, is expressed in many tissues/cells, including innate immunity cells, endothelium and atherosclerotic plaques. its role is controversial: it may exert protective cardiovascular effects and/or it may be an indicator of plaque vulnerability and future cardiovascular risk. ldl-apheresis removes apob100-containing lipoproteins and it can prevent progression of coronary artery disease (cad). ldl-apheresis exerts non-lipidic beneficial effects on the procoagulatory state and on hemorheology. no data exist about the effects of ldl-apheresis on plasma ptx3 levels.

hypercholesterolemic patients with documented cad, on chronic fortnightly ldl-apheresis treatment will be enrolled in this study. blood samples will be collected before and after a single ldl-apheresis treatment to asses ptx3, hscrp, il6, il10, fibrinogen and lipid plasma levels.

Eligibility criteria:
inclusion criteria: * hypercholesterolemia * documented cad * chronic ldl-apheresis treatment exclusion criteria: * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Keywords: hypercholesterolemia ldl-apheresis coronary artery disease ptx3 crp il6 il10
safety and tolerability of nn9068 in healthy male volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of nn9068. the trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.


Eligibility criteria:
inclusion criteria: * male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the investigator. * body mass index (bmi) between 18.0 and 27.0 kg/m2 (both inclusive) * body weight between 60 kg and 90 kg (both inclusive) exclusion criteria: * subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the investigator
persistent postoperative pain incidence with gabapentin used

Conditions: Pain, Postoperative

Summary: the study's objective will be to evaluate the gabapentine efficiency in orally and long term used after painfully surgeries.

this study will be: controlled, prospective, randomized and double blind. its main objective will be to evaluate the pre and postoperative gabapentin efficiency in orally doses and long term used of it in order to prevent or decrease persistent postoperative pain (ppp) in surgeries with high incidence of it (pain). patients will be randomly divided in two branches; one of them will take 600 mg of gabapentin twice a day and the other group will take placebo (twice a day also). both groups of patients will have to take one pill the day before the surgery (300 mg) and other pill on the surgery day (300mg). after that, the patients will have to continue this treatment during 30 days (two doses per day of gabapentin or placebo). after the surgery and after taking the second pill, it will be evaluated: postoperative sharp pain, sickness, vomiting, sedation and adverse effects. patients will be evaluated in the pain treatment office (consulting room) the following times: 1. 30 days after the surgery. (taking drugs suspended) 2. 3 month after the surgery. 3. 6 months after the surgery. 4. 12 months after the surgery this monitoring treatment will be done in order to evaluate the presence or absence of persistent postoperative pain (ppp).

Eligibility criteria:
inclusion criteria: * patients that require persistent painfully surgeries such as breast surgeries (mastectomies and breast implants), herniorrhaphies (not laparoscopical) unilateral or bilateral, amputations of upper and lower limbs and chest surgeries (thoracotomy, thoracoscopy , sternotomies). * patients that had already signed the informed consent. * patients aged between 21 and 75. * asa i - ii _ iii (classification system that the american society of anesthesiologists (asa) uses to estimate the anesthesiology risk that patients may suffer) * bmi, not more than 35 kg/m2. exclusion criteria: * pregnant women * patients that suffer liver and renal failure (plasma creatinine over 1.5 mg/ml or creatinine clearance less than 60 ml/min),heart failure or neurological dysfunction. * diabetic patients * gabapentine allergic patients

Keywords: gabapentin prevention incidence
expression of angiogenic factors in myocardial tissue

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate whether angiogenesis is decreased in diabetic patients with coronary artery disease compared to non-diabetics with coronary artery disease. the protein expression of angiogenic factors will be examined in atrial tissue prior to initiation of cardiopulmonary bypass in patients undergoing coronary bypass surgery. the goal of this project is to evaluate the tissue levels of hif-1, vegf and angiostatin in diabetic and non-diabetic patients coming for on-pump coronary artery bypass graft (cabg).

coronary artery disease and its complications are the leading cause of death in the western world. diabetes mellitus (dm) is one of the major risk factors to develop coronary artery disease, myocardial infarction and post-infarction complication1-3. furthermore, mortality from myocardial infarction is almost doubled in diabetic patients compared to non-diabetics4. despite significant amount of research, the basis for these differences in outcome still remains unclear. the survival of myocardial tissue subjected to ischemia can be increased by the ability to promote growth of new blood vessels into ischemic areas, thus limiting regions of impairment and ultimately preserving myocardial function. hypoxia inducible factor (hif) -1 is a transcription factor that promotes the expression of several genes that confer protection against hypoxia/ischemia through angiogenesis, erythropoiesis, vasodilation, and altered glucose metabolism5,6. our hypothesis is that angiogenesis may be impaired in diabetes mainly via decreased protein expression and activation of hif-1 and its main downstream target vascular endothelial growth factor (vegf), as well as the inhibitor angiogenesis factor, angiostatin7, in the heart. therefore the purpose of this study is to examine whether the angiogenic process during coronary ischemia is influenced by diabetes. to address these questions, hif-1, vegf and angiostatin protein expression will be evaluated in atrial tissue obtained from patients with and without diabetes who will undergo coronary bypass surgery. in addition comparison between emergency and elective procedure will be performed in regard to hif-1 and vegf protein levels and correlation with chronic statin therapy will be performed. during the cannulation process, prior to initiation of cardiopulmonary bypass (cpb) during heart surgery, a small piece of the right atrium is cut in order to insert a venous cannula into that chamber. the investigators intend to use this piece of tissue (that is routinely wasted) in our protein and histological analyses.

Eligibility criteria:
inclusion criteria: 1. on-pump cabg 2. 18 years of age \& older 3. informed consent exclusion criteria: 1. active malignancy 2. severe lung disease (requiring home o2 therapy) 3. severe anemia\<8g/dl 4. patient with moderate or severe renal dysfunction 5. off- pump cabg

Keywords: cabg
a study to test the effects of tolterodine tartrate in patients with overactive bladder (0000-107)

Conditions: Overactive Bladder

Summary: this study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. part ii is dependent on results of part i and may not be conducted.


Eligibility criteria:
inclusion criteria: * patient is a postmenopausal female 40 to 75 years of age * patient has a body mass index (bmi) less than or equal to 35 kg/m2 * patient has a documented history of overactive bladder for at least 6 months prior to screening exclusion criteria: * patient has stress or mixed incontinence * patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain * patient has a history of stroke, seizures, or major neurological disorders * patient has a history of fecal incontinence * patient has a history of continual urine leakage * patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start * patient received bladder training of electrostimulation within 2 weeks of study start * patient requires a catheter * patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants * patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start * patient has been on hormone replacement therapy for less than 12 weeks at study start * patient must take medication for arrhythmia * patient consumes more than 2 alcoholic beverages per day * patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine) * patient has multiple and/or severe allergies to foods and drugs * patient regularly uses any illegal drugs
nac for attenuation of covid-19 symptomatology

Conditions: Covid19; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Lower Respiratory Infection; SARS-CoV2 Infection; SARS-CoV-2 Acute Respiratory Disease; SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere; Oxidative Stress

Summary: the objective of this study is to determine whether oral nac is effective at attenuating covid-19 disease symptom severity and duration of symptoms.

study design: randomized double-blinded placebo-controlled trial eligibility inclusion criteria: * age 18 years and older * participants will need daily access to use of a smartphone for at least six weeks from time of enrollment * positive covid-19 test within 10 days of date of enrollment * not already hospitalized for treatment of covid exclusion criteria: * pregnant * already hospitalized for treatment of covid protocol * 50:50 randomization: half of participants will take nac, half will take placebo * participants will take nac/placebo following this outpatient protocol: * 2400 mg x 1 po then * 1200 mg po bid x 14 days * participants will complete an online symptom-tracker for six weeks (daily for three weeks, weekly for three weeks)

Eligibility criteria:
inclusion criteria: * positive covid test \<= 7 days of enrollment exclusion criteria: * pregnant * already hospitalized due to covid

Keywords: acetylcysteine n-acetylcysteine n-acetyl-cysteine nac glutathione
the salivary microbiome in children with type 1 diabetes mellitus

Conditions: Type1 Diabetes Mellitus

Summary: aims: to profile the oral microbiome of children with type 1 diabetes mellitus, and to compare it to healthy children while taking into account other aspects of the oral environment. research: exploring the differences between oral microflora of children with type 1 diabetes mellitus and control healthy children using salivary microbiome. the investigators will furthermore intend to analyze the differences of salivary flow rate, ph, glucose, calcium, inorganic phosphate and urea between the two groups.

saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the pediatric endocrinology clinic, hadassah university hospital mt. scopus and ein kerem, jerusalem, isreal, will be compared to 50 healthy children, preferably their siblings, matched in age and gender. each patient or their legal guardian will sign an informed consent to participate in the study. the investigators will request a permission to access the medical records of the patients. data will be collected from patient medical history. the investigators will measure salivary flow rate, ph and glucose, salivary calcium, inorganic phosphate and urea and perform microbiome analysis and 16s rrna gene-based analysis comparing children with diabetes to healthy children.

Eligibility criteria:
inclusion criteria: • children with type 1 diabetes mellitus exclusion criteria: * children unable to give saliva sample * children on antibacterial medicaments

Keywords: diabetes mellitus children microbiome
hyperimmune plasma for critical patients with covid-19

Conditions: COVID-19

Summary: the outbreak of severe acute respiratory syndrome coronavirus 2 (sars-cov-2), has become pandemic. to date, no specific treatment has been proven to be effective. promising results were obtained in china using hyperimmune plasma from patients recovered from the disease.the investigators plan to treat critical covid-19 patients with hyperimmune plasma.

apheresis from recovered donors will be performed with a cell separator device , with 500-600 ml of plasma obtained from each donor. donors are males, age 18 yrs or more, evaluated for transmissible diseases according to the italian law. adjunctive tests will be for hepatitis a virus, hepatitis e virus and parvovirus b-19. all donors will be tested for the covid-19 neutralizing title. each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately. based on experience published in literature 250-300 ml of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.

Eligibility criteria:
inclusion criteria: * age \>=18 yrs * positive for reverse transcription polymerase chain reaction (rt-pcr) severe acute respiratory syndrome (sars)-cov-2 * acute respiratory distress syndrome (ards) moderate to severe, according to berlin definition, lasting less than10 days * polymerase chain reaction (pcr) increased by 3.5 with respect to baseline or \>1.8 mg/dl * need for mechanical ventilation or continuous positive airway pressure (cpap) * signed informed consent unless unfeasible for the critical condition exclusion criteria: * moderate to severe ards lasting more than 10 days * proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins * consent denied

Keywords: hyperimmune plasma covid-19
the clinical evaluation of the dose of erythropoietins trial

Conditions: Kidney Failure, Chronic

Summary: anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (ckd). erythropoietin stimulating agents (esas) are the most used treatment option. the purpose of this study is 1. the evaluation of biochemical markers to determine the efficacy of individual prediction of esas therapy 2. to determine the benefits and harms of different esa doses therapeutic strategy for the management of anaemia of end stage kidney disease (eskd).

phase iii pragmatic, randomized-controlled trial comparing different doses of esas in patients with renal anaemia. study sample: total of 900 participants from italy background and rationale: anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (ckd). erythropoietin stimulating agents (esa) are the most used treatment option. in observational studies higher haemoglobin (hb) levels (around 10-13 g/dl) are associated with improved survival and quality of life compared to lower hb levels (around 9 g/dl). randomized studies have found that higher hb targets, achieved and maintained with esa, cause an increased risk of death, mainly due to adverse cardiac-cerebrovascular outcomes. it is possible that such effect is mediated by esa dose. this hypothesis has not been formally tested and is the aim of the clinical evaluation of the dose of erythropoietins (cedose) trial. cedose is the first independent multicentre trial exploring the benefits and harms of different esa doses therapeutic strategy for the management of anaemia of end stage kidney disease (eskd). hypothesis: esa resistance is associated with adverse vascular outcomes and poor quality of life in eskd. the cedose trial will evaluate the biochemical markers to determine the efficacy of individual prediction of esas therapy; moreover it will evaluate the benefits and harms of two fixed esa doses and explore the role of two treatment strategies, one based on a low and one based on a high esa dose. interventions and comparison: patients will be randomized 1:1 to 4000 iu/week iv. versus 18000 iu/week iv. of epoetin alfa, beta or any other epoetin in equivalent doses.

Eligibility criteria:
inclusion criteria: * age \> = 18, * end stage kidney disease and anemia * treatment with hemodialysis for renal replacement therapy * no contraindications to erythropoietin stimulating agents (esas) or already treated with esas exclusion criteria: * patients with hb levels \> 10 g/dl without esas
effects of celecoxib after percutaneous coronary intervention

Conditions: Coronary Arteriosclerosis

Summary: several studies including ours have reported that celecoxib improves endothelium-dependent vasodilation and reduces inflammation and neointimal hyperplasia. our hypothesis is that celecoxib may reduce the late luminal loss after coronary stent implantation (paclitaxel-eluting stent.


Eligibility criteria:
inclusion criteria: * coronary artery disease with at least 1 de novo lesion greater than 50% stenosis on coronary angiography exclusion criteria: * acute st elevation mi * left main disease * contraindications to aspirin, clopidogrel or celecoxib * severe congestive heart failure * expected survival \< 2 years * hepatic dysfunction * currently taking nsaids or any cox-2 inhibitor * renal dysfunction * use of warfarin
histocompatibility leukocyte antigen (hla)-a*0201 restricted peptide vaccine therapy in patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*0201 restricted epitope peptides urlc10, vegfr1 and vegfr2 emulsified with montanide isa 51.

urlc10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cdna microarray technique. in a prior study, it has been shown that urlc10 is upregulated in human esophageal tumors. vegf receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. patients will be vaccinated twice a week for 8 weeks. on each vaccination day, the urlc10-117 peptide(1mg), vegfr1 peptide(1mg) and vegfr2 peptide(1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. in the phase i study, we evaluate the safety and tolerability of these peptide vaccines. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * advanced or recurrent esophageal cancer * resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s) * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*0201 * laboratory values as follows 2000/mm3\ 100000/mm3 bilirubin \< 3.0mg/dl asparate transaminase \< 150iu/l alanine transaminase \< 150iu/l creatinine \< 3.0mg/dl * able and willing to give valid written informed consent exclusion criteria: * pregnancy (woman of childbearing potential:refusal or inability to use effective means of contraception) * breastfeeding * active or uncontrolled infection * unhealed external wound * concurrent treatment with steroids or immunosuppressing agent * prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal metastasis * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: peptide vaccine urlc10 vegfr1 vegfr2
effect of bms-914392 on pharmacokinetics of metoprolol

Conditions: Atrial Fibrillation

Summary: the purpose of the study is to assess the effects of bms-914392 administration on the pharmacokinetics of a single-dose of metoprolol in healthy subjects.

protocol designed to evaluate the potential for a drug-drug-interaction

Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations. * subjects genotyped as intermediate, extensive or ultra-rapid cyp2d6 metabolizers * women of childbearing potential (wocbp) and men must be using an acceptable method of contraception to avoid pregnancy exclusion criteria: * any significant acute or chronic medical illness. * current or recent (within 3 months of study drug administration) gastrointestinal disease. * current or history of neurological diseases or psychiatric disorders, cardiovascular diseases, and bronchospastic diseases. * cyp2d6 poor metabolizers based on genotype
acupuncture for the treatment of chronic daily headaches

Conditions: Headache Disorders

Summary: the purpose of this study is to determine whether acupuncture can reduce pain in long-term headache sufferers.

acupuncture has been shown to reduce the frequency and severity of some types of headaches, but the efficacy of acupuncture for chronic daily headaches has not been studied. the long-term goals of this study are to reduce the symptoms that are associated with recurrent headaches and to collect data that can be used for future acupuncture studies. participants in this study will be randomly assigned to receive 8 weeks of either standard care or ten acupuncture treatments in addition to medical care. self-report questionnaires will be used to assess headaches and daily pain severity.

Eligibility criteria:
inclusion criteria: * ability to communicate in english * presence of headache 15 or more days in the past month exclusion criteria: * known intracranial mass * recent surgery to the head and neck region

Keywords: headache acupuncture