Kornimate/medical-research-clean huggingface dataset:
a study of nasal glucagon in participants with type 1 diabetes mellitus

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Summary: the purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (im) route, in participants with type 1 diabetes mellitus (t1dm).


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes mellitus (t1dm) for at least 2 years and receiving daily insulin since the time of diagnosis exclusion criteria: * have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs * have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma * occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study) * have a history of epilepsy or seizure disorder * are women who are pregnant or lactating * have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing * daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs * require daily insulin treatment greater than (\>)1.5 unit/kilograms (u/kg)/body weight
the ld lync study - natural history study of lipodystrophy syndromes

Conditions: Lipodystrophy (Genetic or Acquired, Non HIV)

Summary: genetic lipodystrophy syndromes are extremely rare, orphan diseases with overall estimated prevalence of less than 2,000 in the united states. these rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications diabetes, dyslipidemia and hepatic steatosis. due to these metabolic problems, atherosclerotic vascular disease, recurrent episodes of acute pancreatitis, cirrhosis and other morbidities complicate the lives of these patients. in the last few years, several genes for cgl (agpat2, bscl2, cav1 and ptrf); fpl (lmna, pparg, akt2, cidec, lipe, plin1, pcyt1a and adra2a); mad (lmna and zmpste24); aps (lmna); autoinflammatory (psmb8); nps (fbn1, cav1); short syndrome (pik3r1); and mdp syndrome (pold1) have been identified. however, there is paucity of information about the natural history of these rare syndromes, especially genotype-specific causes of morbidity and mortality. to overcome the problems outlined above, this multicenter, collaborative, prospective, observational natural history cohort study will be conducted on approximately 500 patients with genetic or acquired lipodystrophy syndromes. patients will be assessed on a yearly basis for approximately 5 to 7 years to collect robust clinical, metabolic, morbidity and mortality data. medical history and patient questionnaires will be completed on a yearly basis by patients registered in the study. clinical data such as vitals, laboratory results and anthropometric measurements will also be collected from patients' medical records if available.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of genetic lipodystrophy supportive data: 1) presence of biallelic known disease-causing variants in the genes for autosomal recessive lipodystrophy syndromes; 2) presence of a known (or de novo loss of function) disease-causing variant in the genes for autosomal dominant lipodystrophy syndromes. exclusion criteria: * hiv-infected patients with lipodystrophy * drug-induced lipodystrophy
maternal loss of control eating

Conditions: Eating Disorder; Obesity

Summary: this study focused on investigating the effects of maternal disordered eating on maternal and child outcomes as part of a secondary data analysis of the avon longitudinal study of parents and children (alspac).

deidentified and anonymised data already collected as part of the alspac study will be analysed to investigate the effects of maternal eating on maternal and child outcomes (diet, eating, weight, metabolic). the avon longitudinal study of parents and children (alspac) is a longitudinal, prospective study designed to examine the effects of environment, genetics and other factors on health and development.all pregnant women living in the geographical area of avon, uk, who were expected to deliver their baby between 1st april 1991 and 31st december 1992, were recruited. 14,541 women were enrolled. amongst these pregnancies, there were a total of 14,676 fetuses, resulting in 14,062 live births and 13,798 children who were alive at 1 year of age and were singletons. the alspac study website contains details of all the data that is available through a fully searchable data dictionary (http://www.bris.ac.uk/alspac/researchers/data-access/data-dictionary/). missingness will be assessed and standard data analytical techniques such as mi will be used.crude and adjusted logistic, linear, and multinomial regression models will be employed.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * multiple pregnancies * no questionnaire data at 32 weeks. eligibility criteria : enrolled in the alspac study; inclusion: all women part of the alspac study;

Keywords: alspac longitudinal
effects of intravenous clonidine on ocular blood flow and intraocular pressure

Conditions: Physiology

Summary: background clonidine, a derivate of imidazol, is an antihypertensive drug. it acts by stimulating adrenergic receptors on nerves in the brain and imidazol-receptors. as a result, clonidine slows the heart rate and reduces blood pressure. clonidine was approved by the fda in 1974 and is registered in austria with the brand name "catapresan". alpha2 adrenergic agonists are nowadays used topically as eye drops in glaucoma treatment. in addition to their known effect of lowering intraocular pressure, alpha2 adrenoceptor agonists are neuroprotective. brimonidine, which is the most commonly used topical alpha-2 agonist, is currently on the market for treatment of glaucoma and is effective in reducing intraocular pressure. it has, however, been shown that brimonidine is a very potent vasoconstrictor in the ciliary body thus reducing aqueous humor production. little is, however, known about potential vasoconstrictor effects of brimonidine in the posterior pole of the eye. this is of clinical importance, because optic nerve head ischemia appears to contribute to glaucoma pathophysiology. direct investigation of the ocular hemodynamic effects of brimonidine is, however, difficult, because lowering intraocular pressure with brimonidine may confound the results due to the concomitant change in ocular perfusion pressure. the aim of the present study is to assess the effect of intravenous clonidine as model drug of alpha agonists on ocular blood flow and iop in healthy humans. study objectives: to investigate effects of clonidine on ocular blood flow and intraocular pressure.


Eligibility criteria:
inclusion criteria: men aged between 19 and 35 years, nonsmokers body mass index between 15th and 85th percentile normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant normal ophthalmic findings, ametropy \< 3 dpt. exclusion criteria: regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study treatment in the previous 3 weeks with any drug symptoms of a clinically relevant illness in the 3 weeks before the first study day history of hypersensitivity to the trial drug or to drugs with a similar chemical structure history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs blood donation during the previous 3 weeks history or family history of epilepsy

Keywords: clonidine glaucoma
mean platelet volume and its relation to risk stratification of myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: the myelodysplastic syndromes (mds) are a group of myeloid neoplasms characterized by abnormal differentiation and maturation of myeloid cells, reduced bone marrow (bm) function, and a genetic instability with enhanced risk to transform to secondary acute myeloid leukemia, aml

the diagnosis of mds is an effort that requires clinicians and pathologists to work together. a patient's life, livelihood and outlook can be profoundly affected by the terms used by the treating physician. the typical presentation is unexplained anemia, leukopenia and/or thrombocytopenia, in an older patients (median age ≥ 70 years). however, thrombocytosis may be associated with the 5q-deletion syndrome or in selected patients with refractory anemia with ringed sideroblasts syndrome . the white count may be elevated in mds / myeloproliferative disorder overlap syndromes particularly in chronic myelomonocytic leukemia, cmml. mds remains among the most challenging of the myeloid neoplasms to diagnose and classify, particularly in cases in which the blast percentage is not increased in the peripheral blood or bone marrow. diagnostic problems can arise when the clinical and laboratory findings suggest mds, but the morphologic findings are inconclusive; when there is secondary dysplasia caused by nutritional deficiencies, medications, toxins, growth factor therapy, inflammation or infection; or when marrow hypocellularity or myelofibrosis obscures the underlying disease process . the prognosis of mds is determined by several factors. revised international prognostic scoring system (ipss-r) for mds divides patients into very low, low, intermediate, high and very high risk groups. five factors (the percentage of bone marrow myeloblasts, the diagnostic cytogenetics, the hemoglobin level, the platelet count and the absolute neutrophilic count) are used to generate a prognostic score .

Eligibility criteria:
inclusion criteria: * all patients diagnosed to have myelodysplastic syndromes exclusion criteria: * no
oxytocin and social behavior over the lifespan

Conditions: Social Activity

Summary: this study will investigate if intranasal oxytocin (a hormone naturally produced in the body) promotes motivation for, and engagement in, social activities in older adults.

using a double-blind and placebo controlled design, this study seeks to determine if a short course of exogenous oxytocin (ot) will induce changes in social activities in residentially housed older adults (oas) during a 10-day treatment period, and after it ends. because ot is associated with peri-reproductive behaviors, ot release in oas is expected to be attenuated relative to younger adults. if ot release is low in oas as we hypothesize, augmenting ot may increase their desire for social interactions, increase the frequency of participation in social activities and augment the number of and quality of social ties, thereby providing protection against disease, early death, cognitive decline, and depression. research in rodents suggests that social interactions themselves may change chronic ot levels (carter \& keverne, 2002; carter \& altemus, 1997), in a positive feedback loop. in order to demonstrate ot as the causal mechanism, we propose to infuse oxytocin and then track the desire for, quantity of, and quality of social activities.

Eligibility criteria:
inclusion criteria: * residentially housed * english fluency exclusion criteria: * non ambulatory * severe psychiatric problems presently or in the recent past * severe medical problems (e.g., cancer, diabetes, advanced heart disease) * irregular heart beat * treatment using psychoactive medications (other than antiepileptics, mood stabilizers, or ambien) * inability to adequately communicate with the research team * treatment with an experimental drug * excessive fatigue suggesting hypothyroidism

Keywords: social isolation cooperative behavior depression loneliness happiness empathy
a research study to see how semaglutide works compared to placebo in people with type 2 diabetes and chronic kidney disease

Conditions: Diabetes Mellitus, Type 2

Summary: the researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. participants will get semaglutide (active medicine) or placebo ('dummy medicine'). this is known as participants' study medicine - which treatment participants get is decided by chance. semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. participants will get the study medicine in a pen. participants will use the pen to inject the medicine in a skin fold once a week. the study will close when there is enough information collected to show clear result of the study. the total time participants will be in this study is about 3 to 5 years, but it could be longer.


Eligibility criteria:
inclusion criteria: * male or female, age above or equal to 18 years at the time of signing informed consent. japan: male or female, age above or equal to 20 years at the time of signing informed consent * diagnosed with type 2 diabetes mellitus * hba1c less than or equal to 10% (less than or equal to 86 mmol/mol) * renal impairment defined either by: 1. serum creatinine-based egfr greater than or equal to 50 and less than or equal to 75 ml/min/1.73 m\^2 (ckd-epi) and uacr greater than 300 and less than 5000 mg/g or 2. serum creatinine-based egfr greater than or equal to 25 and less than 50 ml/min/1.73 m\^2 (ckd-epi) and uacr greater than 100 and less than 5000 mg/g * treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (raas) blocking agent including an angiotensin converting enzyme (ace) inhibitor or an angiotensin ii receptor blocker (arb), unless such treatment is contraindicated or not tolerated. treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening exclusion criteria: * congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations * use of any glucagon-like peptide-1 (glp-1) receptor agonist within 30 days prior to screening * myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening * presently classified as being in new york heart association (nyha) class iv heart failure * planned coronary, carotid or peripheral artery revascularisation * current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
carbon monoxide blood and dna biorepository

Conditions: Carbon Monoxide Poisoning

Summary: the purpose of this biorepository is to collect blood from patients at the time of co poisoning and at follow-up visits months to years later. these samples can be used in the future to learn more about how co damages the heart and brain and whether blood tests could predict which patients will have problems after co poisoning.

the investigators propose to establish a biorepository for storage of serum, plasma, and dna collected from patients with carbon monoxide (co) poisoning. participants will also be evaluated for clinical outcome. the biorepository will include serum and plasma from co-poisoned patients drawn at the time of injury as well as from blood drawn at clinical follow-up visits. the biorepository will also bank dna from these participants. these specimens can be analyzed in the future to elucidate potential inflammatory and immunological mechanisms that cause brain and heart damage and identify possible biological and genetic predictors of poor outcome.

Eligibility criteria:
inclusion criteria: 1. symptomatic carbon monoxide poisoning (headache, nausea, vomiting, dizziness, fatigue, muscle aches, slowed mentation, confusion, loss of consciousness, etc.). 2. documented exposure to carbon monoxide and no other reasonable explanation for their signs and symptoms. exclusion criteria: 1. pregnancy 2. age \< 18 years 3. unable to obtain informed consent 4. subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason. the investigator and the sponsor, prior to enrolling the subject on a case-by-case basis, must approve and document any waiver of these inclusion and exclusion criteria. 5. anemia requiring blood products within the last 4 months or hematocrit less than the laboratory normal reference range

Keywords: co poisoning
safety study of peptide cancer vaccine to treat hla-a*24-positive advanced small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of hla-a\*2402 restricted epitope peptides cdca1 and kif20a emulsified with montanide isa 51 for advanced small cell lung cancers.

the investigators previously identified three novel hla-a\*2402-restricted epitope peptides, which were derived from two cancer-testis antigens, cdca1 and kif20a, as targets for cancer vaccination against lung cancer. in this phase i trial, the investigators examine using a combination of these two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for hla-a\*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Eligibility criteria:
inclusion criteria: 1. sclc that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy 2. ecog performance status 0-2 3. age between 20 to 85 4. clinical efficacy can be evaluated by some methods 5. no prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks 6. life expectancy \> 3 months 7. laboratory values as follows 1500/mm3 \ 75000/mm3 asparate transaminase \< 3 x cutoff value alanine transaminase \< 3 x cutoff value total bilirubin \< 3 x cutoff value serum creatinine \< 2x cutoff value 8. hla-a\*2402 9. able and willing to give valid written informed consent exclusion criteria: 1. active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. myocardial infarction within six months before entry 3. breastfeeding and pregnancy (woman of child bearing potential) 4. active and uncontrolled infectious disease 5. concurrent treatment with steroids or immunosuppressing agent 6. other malignancy requiring treatment 7. non-cured traumatic wound 8. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: cdca1 kif20a lung cancer vaccine hla-a*2402
clinical evaluation of water immersion colonoscopy insertion technique

Conditions: Colonoscopy; Digestive System; Endoscopy; Gastrointestinal Disease

Summary: recent studies indicate that infusing 300 milliliters of water (in lieu of air) into the rectum and left colon through the colonoscope as it is being inserted during a colonoscopy examination can allow easier endoscope advancement. this method may prevent stretching of the colon, and ultimately reduce pain induced during colonoscopy. improvements in patient comfort and cooperation, may increase the efficiency and success rate of complete colonoscopy. the purpose of the study is to test the efficacy of the water immersion technique in patients colonoscopy.


Eligibility criteria:
inclusion criteria: * presentation for colonoscopy * male * age 18 or older exclusion criteria: * women * known inflammatory bowel disease * presentation for emergency colonoscopy * history of partial colectomy * chronic narcotic or benzodiazepine use

Keywords: colonoscopy diagnostic techniques digestive system endoscopy gastrointestinal
histocompatibility leukocyte antigen (hla)-a*0201 restricted peptide vaccine therapy in patients with non-small cell lung cancer

Conditions: Non Small Cell Lung 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. we have determined the hla-a\*0201 restricted epitope peptides derived from these molecules. we also tend to use the peptides targeting to tumor angiogenesis. 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 vaccine. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: disease characteristics * advanced or recurrent non small cell lung cancer * second line or later therapeutic status patient characteristics * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*0201 * laboratory values as follows * 2000/mm3\<wbc\<15000/mm3 * platelet count\>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, or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal metastasis * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: hla-a*0201 peptide vaccine urlc10 vegfr1 vegfr2