Kornimate/medical-research-clean huggingface dataset:
metabolites of tramadol in the postoperative surgical patients

Conditions: Abdominal Surgery; Respiratory Failure; Renal Failure; Liver Dysfunction; Multiorgan Failure

Summary: tramadol is opioid analgesic widely used to treat moderate to severe pain. it is metabolized by cytochrome cyp2d6 into two major metabolites: pharmacologically active metabolite o-desmethyltramadol (m1) and inactive n-desmethyltramadol (m2), respectively. tramadol kinetics in a population of patients undergoing major abdominal surgical procedures, and in patients with a greater or lesser degree of organic failure, is still not well researched. the investigators will measure plasma concentrations of tramadol and its metabolites after usual tramadol doses in icu patients after major abdominal surgery. also analgesic affect and side effect of tramadol will be recorded.

the blood samples for the cyp2d6 gene polymorphism analysis will be taken from all patients included in the study. the patients will be categorized as slow (pm), normal (nm) or ultra-fast metabolizers (um) of tramadol using analysis of the cyp2d6 phenotype. standard laboratory findings including red blood cells, urea, creatinine, and cholinesterase will be done before surgery. the patients will receive 500 mg of tramadol intravenously divided into 5 doses during the first 24 postoperative hours in the icu. the plasma concentrations of tramadol, o-desmethyltramadol and n-desmethyltramadol will be measured 1, 2 and 4 hours after the first dose, and immediately before the 2nd, 3rd and 5th dose. there will therefore be 6 measurements of tramadol and its metabolites. the analgesic effect of tramadol will be measured in awake patients with numeric rating scale - nrs (0 - without pain, 10 - strong pain) 30 minutes before and 30 minutes after tramadol administration. the nrs value of 3 or less will be considered as adequate analgesia. in case of inadequate analgesia rescue analgesic (morphine) will be used according to the local protocol. in unconscious patients the analgesic effect of tramadol will be tested by critical care pain observation tool (cpot). the cpot value of less than 2 will be considered as adequate analgesia. in case of inadequate analgesia rescue analgesic (morphine) will be used according to the local protocol. during the first 24 hours side effect of tramadol, such as nausea, vomiting and new respiratory depression will be recorded.

Eligibility criteria:
inclusion criteria: * patients after major abdominal surgery will be observed. * surgical interventions requiring a laparotomy and involving resection of the organs of the digestive system * postoperative icu admission. exclusion criteria: * allergic reaction to tramadol * patients under 18 years old * patient over 90 years old * bmi \ 35 * laparoscopic surgery * chronic therapy with tramadol, cimetidine, paroxetine, pimozide, metoclopramide, amiodarone, olanzapine, chlorpromazine, fluphenazine, haloperidol, thioridazine, risperidone and clozapine

Keywords: tramadol cyp2d6 polymorphism analgesia intensive care organ failure
impact of post-bariatric body contouring procedures on patient body weight and metabolism

Conditions: Bariatric Surgery Candidate

Summary: is post-bariatric body contouring surgery prevent weight regain or no, and what is the effect on the patient's metabolism? few literature studies report body contouring surgery to be positively associated with maintained weight loss after obesity surgery but the measures of outcomes are diverse, and the collective magnitude of such an association is unknown. the changes in gastrointestinal hormones, adipokines, and cytokines as well as in hypothalamic neuropeptides and neurotransmitters resemble the changes observed in the anorexia/cachexia, suggesting that bariatric surgery triggers a catabolic state responsible for loss of appetite and prolonged body weight reduction. weight regain after gastric bypass surgery occurs in about half of all patients within 2 years. about 50% of patients eventually gain a little weight back after hitting their low point. we need a more thorough evaluation to determine what factors - medical, psychological, lifestyle - are involved in the weight gain. one of the factors that seem to be responsible for the degree and durability of weight loss is post-bariatric body contouring procedures. however, metabolic consequences of removing excess subcutaneous adipose tissue by body contouring procedures have to a lesser extent been explored


Eligibility criteria:
inclusion criteria: * post-bariatric (sleeve) patients will do body contouring surgery. * post-bariatric patients has been stable within 5 kg for 3 months * age between 20-60 years old. * patients use the determinant fixed diet. exclusion criteria: * age below 20 and above 60 years old. * non-compliance with the fixed diet. * psychotic patients. * female patients seeking pregnancy. * endocrine causes of obesity. * bariatric surgery other than sleeve.

Keywords: bariatric weight regain metabolism
safety and immunogenicity of the live oral cholera vaccine candidate pxvx0200

Conditions: Cholera

Summary: the purpose of this study is to compare the safety and immunogenicity of a single dose of the pxvx0200 live cholera vaccine versus placebo in volunteers (vaccinees) and whether pxvx0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.

approximately 60 subjects and up to 120 household contacts will be enrolled in the united states. vaccinees will be randomly assigned to receive either pxvx0200 or placebo in a 5:1 ratio and will be followed for 180 days postdose.

Eligibility criteria:
inclusion criteria: * healthy men or women, age 18 to 50 years (inclusive) without significant medical history, physical or clinical lab abnormalities (as per protocol defined ranges) * women of childbearing potential must have negative urine pregnancy test and must be willing to use adequate birth control for 2 months following vaccination and have additional pregnancy tests as indicated * vaccinees must live alone or have no more than two household contacts willing to sign informed consent and participate in the study * household contacts must be healthy (based on medical history) men or women aged 18-65 years (inclusive) exclusion criteria: * healthcare workers who have direct contact with patients who are immunodeficient, are hiv-positive, have unstable medical condition or are under the age of 18 * childcare workers who have direct contact with children who are 2 years of age or younger or those employed in the food service industry * resides with hhcs who are under the age of 18 or over the age of 65 * has abnormal stool pattern defined as fewer than 3 stools per week or more than 2 stools per day in past 6 months * has known allergy to, or known medical condition that precludes the use of both tetracycline or ciprofloxacin * previously received a licensed or investigational cholera vaccine * has history of cholera or enterotoxigenic e. coli infection (natural infection or experimental challenge) * travel to a cholera-endemic area and experienced symptoms consistent with traveler's diarrhea in the previous 5 years * received or plans to receive any other licensed vaccines from 14 days prior to the study vaccination until day 28 * received or plans to receive antibiotics (other than protocol-specified) or chloroquine within 14 days prior to the study vaccination through to day 28

Keywords: vaccine, bacterial disease condition, cholera
therapies on newly diagnosed type 2 diabetes patients with high glucose toxicity which protect islet β cell

Conditions: Type 2 Diabetes Mellitus

Summary: prevalence of diabetes is increasing rapidly both in china and all over the world.hyperglycemia is an important risk factor and major hazard to cardiovascular and cerebrovascular diseases and even dangerous to human health."high glucose toxicity "cause pancreatic β cell non-physiologic and irreversible damage.it is an important cause of β cell dysfunction.high glucose toxicity further suppresses insulin secretion of β cell, further even β-cell function failure.it is urgent to explore more effective and safety treatments which can also protect islet cells function.how to release high glucose toxicity , reverse the toxic effects of hyperglycemia on islet β cells as early as possible, and to maximize recover and protect the pancreatic β cell function is the keypoints of this study.our aim is to explore the non-inferiority of new antidiabetic drugs dpp4 inhibitors on releasing glucose toxicity and protecting islet β cell function compared with traditional treatments on newly diagnosed type 2 diabetes,compare efficacy and safety of different oral antidiabetic drugs and insulin on newly diagnosed type 2 diabetes patients with high glucose toxicity and compare differences of different oral antidiabetic drugs and insulin on protecting pancreatic β-cell function.

patients were divided into 3 groups: 1. dpp-4 inhibitor treatment group (45 cases): dpp-4 inhibitor (sitagliptin phosphate) combined with metformin and/or acarbose; 2. insulin treatment group (45 cases): insulin (insulin glargine or insulin detemir) and/or metformin; 3. sulfonylureas treatment group (45 cases): sulfonylureas combined with metformin and/or acarbose;

Eligibility criteria:
inclusion criteria: * newly onset * type 2 diabetes * bmi 18-30kg/m2 * fbs≧11.1mmol/l，ghba1c≧9% * urine ket ≦(1+) * normal liver and kidney function exclusion criteria: * type 1 diabetes * renal or hepatic insufficiency * severe ketoacidosis * treatment with corticosteroids, immunosuppressive agents or cytotoxic drugs * severe systemic disease * history of pancreatitis or pancreatic surgery * pregnant and lactating women
a study comparing ly900014 to insulin lispro (humalog) in adults with type 1 diabetes using insulin pump therapy

Conditions: Type 1 Diabetes Mellitus

Summary: the reason for this study is to compare the study drug ly900014 to insulin lispro (humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (t1d).


Eligibility criteria:
inclusion criteria: * have been diagnosed with t1d and continuously using insulin for at least 1 year * have been using csii therapy for a minimum of 6 months * currently treated with \<100 units of one of following rapid-acting analog insulin via csii for at least the past 30 days: insulin lispro u-100, insulin aspart, fast-acting insulin aspart, insulin glulisine * must be using a minimed 530g (us), paradigm revel (us), or minimed 630g (us and canada), minimed 640g or paradigm veo (select countries outside the us), insulin pump for at least the past 90 days exclusion criteria: * have hypoglycemia unawareness * have had more than 1 episode of severe hypoglycemia within 6 months prior to screening * have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
advanced endoscopic imaging in colonoscopy

Conditions: Polyps; Neoplasms

Summary: the aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice. the important elements of this evaluation are: * evaluation of the character of neoplastic lesions in the colon based on different imaging techniques * verification of the endoscopic image with histopathologic descriptions * establishing the type of the lesion on the basis of kudo and nice classifications * comparison of the result of histopathological examination with the macroscopic type of the lesion * determination of the most advanced lesions (mal) * comparison of the cecal intubation time * evaluation of the type of anesthesia used during colonoscopy * subjective assessment of the severity of pain according to vas (visual analogue scale) * comparison of the accuracy of the location of lesions on the basis of endoscopic navigation * comparison of the total examination time * comparison of adenoma detection rate

a total of 400 consecutive patients undergoing unsedated colonoscopy as a part of a national colorectal cancer screening program will be randomly assigned to innovative or conventional examination. randomization will be based on computer-generated randomization lists. all patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. in innovative colonoscopy group narrow band imaging (nbi) and dual focus (df) function will be used to identify and classify all lesions according. to kudo and nice classification. endoscopic biopsy samples will be taken from all lesions and in vivo endoscopic diagnosis will be compared with final histopathological result. thus, sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and youden index will be calculated. as secondary endpoints total examination time, cecal intubation rate and pain intensity (vas) will be determined. this study will help to establish whether advanced imaging technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

Eligibility criteria:
inclusion criteria: * written informed consent * no previous abdominal surgery * no colonoscopy during last 10 years exclusion criteria: * age \ 65 years * large bowel resection in history * colonoscopy performed during last 10 years * contraindications for general anaesthesia * asa \> iv * pregnancy * confirmed neoplastic disease * cirrhosis (child b or c) or ascites * immunosuppressive therapy or steroids intake * malabsorption syndrome * ibd * gi neoplastic disease

Keywords: narrow band imaging colorectal cancer screening colonoscopy responsive insertion technology near focus
flaxseed modulates inflammation and oxidative stress in cf

Conditions: Cystic Fibrosis; Oxidative Stress; Inflammation

Summary: flaxseed (fs) is a safe and well tolerated supplement with an ability to fight inflammation and oxidative stress - a byproduct of daily stress the human body faces everyday and especially with chronic diseases. cystic fibrosis (cf) is a genetic disease resulting from a mutation in sodium and chloride transport channels that results in pancreatic insufficiency, chronic sinusitis and chronic lung infections. the investigators hypothesize that chronic inflammation and oxidative stress are a part of the chronic exacerbations that are a part of cystic fibrosis. the investigators believe that flaxseed with its anti-inflammatory and antioxidative properties can help dampen these stressors on the cf lung and potentially result in fewer exacerbations of cf, fewer antibiotics, fewer hospitalizations, and improved well-being.

ten patients with steady-state cystic fibrosis (cf) - not hospitalized, not on intravenous antibiotics, with stable fev1 40-100% predicted were enrolled in a four week long pilot study where-in each patient consumed 40 grams of flaxseed each day, in the form of finely ground flaxseed, however they wished. prior to starting flaxseed, each week, and then four weeks after each patient had finished taking flaxseed, markers of inflammation and oxidative stress, as well as measurements of flaxseed metabolism were collected. f2-isoprostanes, 8-oxo-dguo, as well as cytokines including il-6, tnf-a, ifn-g among others were measured to trend flaxseed effects. enterolignans - enterodiol and enterolactone (products of flaxseed metabolism) were measured each week as well.

Eligibility criteria:
inclusion criteria: 1. genetic and clinical diagnosis of cystic fibrosis (cf) 2. fev1 predicted between 40-100% 3. age 18-64 4. pancreatic enzyme adherence (or pancreatic sufficiency) 5. demonstration of continued long-term dedication and follow-up with cf primary care provider exclusion criteria: 1. prior or planned hospitalization or surgical procedure within one month of enrollment (other than simple dental procedure) 2. an acute pulmonary exacerbation 3. history of bowel resection, inflammatory bowel disease or distal intestinal obstruction syndrome 4. receiving broad spectrum intravenous antibiotics (other than maintenance azithromycin, inhaled tobramycin, or inhaled aztreonam within one month of enrollment) 5. current supplementation with fs or soy derivatives or allergies to them 6. active or prior ingestion of vitamin e exceeding 30 iu within 21 days 7. significant liver disease (cirrhosis) 8. significant renal dysfunction (gfr below 50 ml/hr/m2) 9. poorly controlled diabetes (evidenced by hgba1c\>7.5% or consistently with blood glucose \>250 mg/dl)

Keywords: cystic fibrosis isoprostanes 8-oxo-dguo oxidative stress inflammation flaxseed enterodiol enterolactone
a study of the relationship of psychosocial function with mood symptoms in offspring of parents with bipolar disorder

Conditions: Bipolar Disorder

Summary: the primary purpose of this study is to compare, over 24 months, the time spent with clinically significant mood symptoms (ie, mania, depression), as measured by the longitudinal interval follow-up evaluation (life) and the psychiatric status rating scale (psr), in offspring of bipolar parents with and without at least mild impairment in psychosocial functioning.


Eligibility criteria:
inclusion criteria: * participants must have at least one parent who meets the criteria for diagnosis of bipolar i disorder (bd-i) or bipolar ii disorder (bd-ii), as confirmed by the mini international neuropsychiatric interview (mini) administered to the parent. mini will be administered to parent if the history of bd is endorsed by family index of risk for mood (firm) or other medical information (psychiatrist, medical records). the mini can be administered to the parent remotely through the telephone or video call if an in-person interview is not feasible due to logistical reasons. a diagnosis bipolar disorder not otherwise specified in the parent would not qualify for eligibility * participants must be either drug-naive, or on stable treatment for at least 4 weeks. * participants (and/or their parents as applicable) must sign an informed consent form (icf) allowing data collection and source data verification in accordance with local requirements and/or sponsor policy. adolescents (minors) who in the judgment of the investigator are capable of understanding the nature of the study can be enrolled only after obtaining consent of a legally acceptable representative. assent must be obtained from any participating adolescents (minors), if applicable * participants must be willing and able to complete self-reported assessments via mobile electronic device, and to wear a wrist actigraphy device for the duration of the study exclusion criteria: * diagnostic and statistical manual of mental disorders (dsm) -iv diagnosis of bipolar i or bipolar ii disorder * dsm-iv diagnosis of schizophrenia, schizophreniform or schizoaffective disorder * dsm-iv diagnosis of neurodevelopmental disorders * an intelligence quotient (iq) score less than (\<) 80 as determined by kaufman brief intelligence test (k-bit) * uncorrected hypothyroidism or hyperthyroidism

Keywords: bipolar high-risk off-spring psychosocial functioning
screen-detected coeliac disease, a population based study

Conditions: Celiac Disease

Summary: the purpose of this study is to determine the prevalence of previously undiagnosed coeliac disease based on a health survey from tromsø, norway. moreover, the health impact of undiagnosed coeliac disease will be examined.

few population-based studies have examined the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health. moreover, the number of people with undiagnosed coeliac disease is much higher than the number who know their diagnosis. the purpose of this study is to determine the prevalence of coeliac disease and the impact of undiagnosed coeliac disease on health. in a health survey of the population of tromsø norway, serological markers of coeliac disease (transglutaminase 2, tg2 and deamidated gliadin antibody test) have been analyzed. individuals with increased level of one of these markers, will be invited for upper endoscopy with small bowel biopsy examination to confirm the diagnosis of coeliac disease. all persons with screen detected coeliac disease, will be advised to start a gluten free diet. health status and quality of life will be examined by means of the gastrointestinal symptoms rating scale (gsrs) and the psychological general well-being index (pgwbi) respectively. 1. at baseline gsrs and pgwbi will be analyzed in persons with screen detected and biopsy verified coeliac disease and compared with a group of healthy control persons from the health-survey cohort. 2. in a prospective study of the persons with screen detected coeliac disease, health status (gsrs) and quality of life will be compared before and after one year on a gluten free diet.

Eligibility criteria:
inclusion criteria: * increased level of serological markers (transglutaminase 2 or deamidated gliadin) and biopsy verified coeliac disease exclusion criteria: * previously diagnosed coeliac disease

Keywords: quality of life celiac disease/diet therapy celiac disease/diagnosis prospective studies
post cesarian section wound infections at emergency room

Conditions: Surgical Wound Infection

Summary: the goal of this observational study is to compare the incidence of post-cesarean section wound infections between emergency and elective cesarean deliveries at el-hussien hospital. the main questions it aims to answer are: is there a difference in surgical site infection rates between emergency and elective cesarean sections? what are the other outcome measures associated with emergency versus elective cesarean deliveries? participants will be 220 patients undergoing cesarean section, divided into two groups: 110 patients undergoing emergency cesarean delivery in the emergency unit 110 patients undergoing elective cesarean delivery researchers will compare the emergency cesarean group to the elective cesarean group to see if there are differences in surgical site infection rates and other relevant outcome measures.


Eligibility criteria:
inclusion criteria: * age \> 18 * managed with elective cs or emergency cs * bmi \< 25 kg/m2 exclusion criteria: * immunodeficiency or diabetes. * premature rupture of membrane * bleeding disorder. * previous uterine surgery except previous cs. * malignancy. * refusal to participate.

Keywords: surgical site infections elective cesarean delivery emergency room
efficacy of roflumilast in prevention of peripheral neuropathy

Conditions: Peripheral Neuropathy

Summary: there are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. one of the main mechanisms is induction of schwann cell dedifferentiation by paclitaxel. at the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured schwann cells, yet this positive effect have not been clinically investigated.


Eligibility criteria:
inclusion criteria: 1. breast cancer patients who will receive paclitaxel post-anthracycline therapy. 2. eastern cooperative oncology group (ecog) performance status from 0 to 2. 3. adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine \< 1.5 mg/dl). exclusion criteria: 1. patients with signs and symptoms of clinical neuropathy at baseline. 2. patients with diabetes mellitus or alcoholic disease. 3. patients receiving vitamin/ supplementation drugs that interfere with the study intervention.