Kornimate/medical-research-clean huggingface dataset:
ketamine-midazolam as a sedative agent in endoscopic retrograde cholangiopancreatography.

Conditions: Cholangitis; Pancreatic Cancer; Choledocholithiasis; Choledochal Cyst

Summary: does ketamine-midazolam have a better efficacy and safety profile compared to midazolam - pethidine in endoscopic retrograde cholangiopancreatography (ercp)?

ketamine- midazolom is more efficacious in producing desired sedative state and have a better safety profile as a sedative agent in ercp compared to midazolam- pethidine. the usage of sedative agent in ercp depends on surgeon's preferences and availability of the drugs. the most commonly used sedatives in ercp is midazolam with pethidine. the use of midazolam , however, is related to: 1. 20-45% failure of sedation during ercp 2. cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8% due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ercp is more effective and better safety profile when compared to midazolam- pethidine. the synergistic effect means to reduce the total dose of midazolam used.

Eligibility criteria:
inclusion criteria: * adults \> 18 years old which able to give valid consent * patient planned for ercp (either emergency or elective) * american society of anaesthesiologist (asa) score of i-iii exclusion criteria: * known hypersensitivity towards ketamine or midazolam * increased intracranial pressure, acute stroke (\<3 months), intracranial haemorrhage (\<3 months) * severe hypertension (bp\>170/110) and tachycardia (heart rate \>110) * acute myocardial infarction, acute coronary syndrome (\< 6 months) * tachyarrhythmia * pregnancy * intravenous drug user (ivdu) or substance abuse patient * history of hallucination * child's pugh class c

Keywords: ketamine midazolam sedation ercp
sccor minorities observational study

Conditions: Pulmonary Disease, Chronic Obstructive; Emphysema

Summary: the sccor minorities study will recruit minority participants from the copdgene cohort, in whom the university of pittsburgh has already obtained baseline and five year data, in order to enhance bone mineral density and vascular function data collection from minority smokers. dual x-ray absorptiometry (dxa) scans will be obtained to measure bone mineral density. non-invasive vascular studies will be performed to measure endothelial function. questionnaires regarding symptoms and activity levels will be administered and a blood sample will be obtained in participants in which blood samples are not already available from the copdgene study visits.


Eligibility criteria:
inclusion criteria: * african american male and female subjects participating in copdgene study exclusion criteria: * caucasians * pregnant women
multicentric study of coronavirus disease 2019 (covid-2019) in solid organ transplant recipients

Conditions: Transplant Recipient; Infections, Coronavirus

Summary: the overall purpose of this project is to better understand the incidence, risk factors, etiology, clinical manifestations and outcome of tcovid19 in solid organ transplant recipients. the results obtained will allow us to gain insight on the need of antiviral treatment, on the strategy for complications surveillance, on how to adjust the immunosuppressant therapy and on the level of care in which each patient should be treated. in order to attain the objectives previously described we will develop a multicenter prospective study of consecutive cases of covid-19 among solid organ transplant recipients.

there will be a clinical follow-up of the patients included in this study to observe possible complications and survival rate. data collected form this study will be evaluated with a descriptive statistical analysis of the cohort consisting of analysis of the risk factors of covid-19. subsequently a multivaried logistic regression analysis will be performed in which the factors selected from the analysis and those clinically relevant.

Eligibility criteria:
inclusion criteria: * patients older than 16 years with a solid organ transplant diagnosed of covid-19. note: a confirmed case of infection, is defined by a clinical syndrome that is compatible to that of an respiratory infection (fever, cough and/or dyspnea) and the presence of a positive microbiological result. exclusion criteria: * absence of informed consent after giving the information regarding the study.

Keywords: transplant recipient covid-19
pragmatic use of pain-advanced dementia scale in emergency departments

Conditions: Dementia; Hip Pain; Emergency Department Patient; Pain in Advanced Dementia Scale

Summary: the purpose of this study is to learn if the pain in advanced dementia (painad) scale can improve emergency pain care in persons living with dementia (plwd). it is hypothesized that a painad electronic health record (ehr) prompt that appears to emergency department (ed) staff will enable them to accurately assess pain levels and lead to better pain treatment for plwd.

this is a pragmatic pilot for a stage iv effectiveness, embedded pragmatic clinical trial (epct) studying the feasibility of painad assessment implementation via simple ehr prompts for plwd presenting to the ed with hip pain at the university of chicago medicine (ucm) and the university of north carolina at chapel hill (unc-ch). identification of subjects with hip pain and dementia contains the level of specificity needed for a pragmatic trial, and occurs on ed arrival, prompting an electronic health record clinical decision support (cds). the pain in advance dementia (painad) score is a behavioral score based on observation of the person. the score depends on observation of five behaviors, breathing, negative vocalizations, facial expressions, body language, and consolability. each observed behavior is scored from zero = none, to two = most, for a total score from zero to ten. the design is an interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of painad scale. pre-intervention data from most immediate year to date prior to the intervention start defines the baseline state. the intervention, the ehr prompt to document the painad first on patient arrival to the ed treatment area, and second one hour after delivery of first pain treatment. prospective evaluation of ehr data will be used to evaluate use of the painad.

Eligibility criteria:
inclusion criteria: * patients greater than or equal to 65 years old * ed arrival complaint of hip pain * history of dementia by past medical history or problem list in ehr exclusion criteria: * patients do not meet inclusion criteria
blood for immune response to provenge® in hrpc

Conditions: Prostate Cancer

Summary: this study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving provenge® (sipuleucel-t) therapy as part of their standard of care treatment regimen.

this study is being conducted to assess and monitor immune response in patients with minimally symptomatic or asymptomatic hormone refractory prostate cancer who will be receiving provenge® (sipuleucel-t) therapy as part of their standard of care treatment regimen. the trial only involves the collection of additional blood samples for the purposes of monitoring immune response. these samples will be taken at 7 time points before, during and after patients receive provenge® (sipuleucel-t). there will be no other study-specific procedures performed (other than the blood draws) nor any use of investigational agents in this study.

Eligibility criteria:
inclusion criteria: patients who plan to receive standard of care provenge® (sipuleucel-t) at their primary physican's office. exclusion criteria: none
digidiab pilot: impact study hospital

Conditions: Type 2 Diabetes

Summary: glucotab is an innovative workflow and decision support tool for standardised diabetes management by healthcare professionals which provides automated and personalised dosage recommendations for different insulin therapy regimens.

glucotab has already been tested in several clinical trials in austria and has consecutively obtained the ce-mark that is valid throughout european countries. the current study aims to further develop, implement and evaluate glucotab in different european pilot regions. for this reason, glucotab will be translated in different languages and tested in sweden, denmark, and spain.

Eligibility criteria:
inclusion criteria: * informed consent obtained after being advised of the nature of the study * a documented history of type 2 diabetes prior to inclusion or new-onset hyperglycaemia which requires s.c. insulin therapy during hospital stay * admission to either surgical or internal medicine ward * an expected length of hospital stay for at least 48 hours after enrolment exclusion criteria: * type 1 diabetes mellitus * intravenous insulin therapy * hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy * continuous subcutaneous insulin infusion * gestational diabetes or pregnancy * known or suspected allergy to insulin * total parenteral nutrition * any mental condition rendering the patient incapable of giving his/her consent * any disease or condition which according to the investigator or treating physician would interfere with the trial or the safety of the patient inclusion and exclusion criteria will be the same as above for the retrospective cg with the exception of: * period of time will be from september 2022 to september 2023 * no informed consent will be obtained from the retrospective cg

Keywords: glucotab type 2 diabetes
evolution® biliary stent system clinical study

Conditions: Biliary Tract Neoplasms; Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Biliary Tract; Stents

Summary: the evolution® biliary stent system clinical study is a clinical trial on a commercially available device to gather physician experience with the cook evolution® biliary stent system for the palliation of cancer in the biliary tree. patients will be treated as per usual medical practices.


Eligibility criteria:
inclusion criteria: * patient is considered a candidate for stent placement based on institutional guidelines and product ifu. exclusion criteria: * patient is less than 18 years of age. * patient is unable or unwilling to provide written informed consent. * patient is unable or unwilling to comply with the follow-up schedule.

Keywords: biliary tract neoplasms neoplasms gastrointestinal diseases digestive system diseases biliary tract stents
differences in ovarian reserve markers and vitamin d between infertile indian, arabian and caucasian population

Conditions: Female Infertility Due to Diminished Ovarian Reserve; Vitamin D Deficiency; Hormone Deficiency; Follicular Cyst of Ovary

Summary: the aim of this study is to confirm the difference in ovarian reserve markers and serum vitamine d levels between infertile indian, arabian and caucasian population.

200 caucasian, indian, and arab patients

Eligibility criteria:
inclusion criteria: women between 21-43 years first or second in vitro ferilization treatment due to tubal, masculine or previous intrauterine insemination fail treatment exclusion criteria: polycystic patients endometriosis grade iii or iv inflammatory pelvic disease

Keywords: amh, acf, vit d, ethnicity
prevalence of renal artery stenosis in patients referred for cardiac catheterization

Conditions: Renal Artery Stenosis

Summary: all patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data.

renal artery stenosis (ras) is a common finding in patients with generalized atherosclerosis. it is the cause of 15-20% of end stage renal disease in elderly patients. the prevalence of asymptomatic ras in general population is unknown but it estimated to be 18% in 7th decade and more than 50% in the 8th. it is critical to find and manage the ras before it's symptoms appear. the gold standard for diagnosis of atherosclerotic arterial stenosis is angiography. in this study we will evaluate the prevalence, severity, location and related factors to renal artery stenosis in patients whom referred for coronary angiography in period of july-september in one of the most referral heart center in iran, "the tehran heart center" which is doing more than 50 coronary angiography daily.

Eligibility criteria:
inclusion criteria: * age more than 18 years exclusion criteria: * contraindication to contrast use * not signing consent

Keywords: ras(renal artery stenosis) atherosclerosis angiography
a single and multiple ascending dose study to evaluate the safety and pharmacokinetics of pu-ad in healthy subjects

Conditions: Alzheimer's Disease

Summary: this is a first in human phase 1 study in two parts with healthy volunteers receiving a single dose of pu ad in three small cohorts and a multiple ascending dose in two small cohorts.

this is a phase 1, double-blind trial in two parts. a single ascending dose study in approximately 3 cohorts receiving a single oral dose of pu-ad or placebo and a multiple ascending dose study in 2 cohorts. each subject in all cohorts will be administered an oral solution of pu ad or placebo under fasting conditions. each cohort will contain subjects randomized to active treatment or placebo, evaluating safety and tolerance.

Eligibility criteria:
inclusion criteria: 1. male or female (women of non-child bearing potential) 2. 18 to 60 years of age for part one, \>/= 60 years of age for part two exclusion criteria: 1. women of child bearing potential or female with positive pregnancy test or who is lactating. 2. history or presence of conditions, which in the judgment of the pi, are known to interfere with the absorption distribution, metabolism, or excretion of drugs. 3. history or presence of conditions that may place the subject at increased risk as determined by the pi. 4. has taken other investigational drugs or participated in any clinical study within 30 days. 5. any other condition or prior therapy that, in the pi's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures

Keywords: pu-ad
study of applying acupressure in low-birth weight premature

Conditions: Premature

Summary: the purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.

a quasi-experimental study is designed. sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (\<1500gm) from a sick baby room in a medical center. the control group only receive routine care in sick baby room unite. the babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. the intervention includes acupressure for 15 minutes each at 10am, 1pm and 4pm.

Eligibility criteria:
inclusion criteria: * according to the criteria of very low birth weight (\<1500gm) from a sick baby room in a medical center. exclusion criteria: * exclusion criteria of very low birth weight (\>1500gm) from a sick baby room in a medical center.

Keywords: acupressure very-low- birth-weight premature body weight behavioral state developmental status
the safety, tolerability and metabolism of gsk221149a, in pregnant women (30-36 weeks), in pre-term labor

Conditions: Obstetric Labour, Premature

Summary: pre-term labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. oxytocin is a hormone produced by the body during labor. gsk221149a is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. in this study, patients with preterm labor will be given an intravenous infusion of gsk221149a over approximately 12 hours followed by an oral tablet in parts a and b. in part c of this study, patients with preterm labor will be give an intravenous infusion of gsk221149a over approximately 48 hours. the use of a rescue tocolytic is allowed in the study.

a randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of gsk221149a administered intravenously and to investigate the pharmacokinetics of gsk221149a administered orally to healthy, pregnant females with uncomplicated pre-term labor between 300/7 and 356/7 weeks' gestation

Eligibility criteria:
inclusion criteria: * healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes * 18-45 inclusive * symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour, each of which at least 30 sec in duration, with cervical dilatation of less than or equal to 4 cm, (measured by tocodynamometry). exclusion criteria: * any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the patient (mother and/or fetus) unsuitable for participation in the study * any clinically relevant pre-existing or pregnancy-related co-morbid condition that may affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes mellitus, bleeding/clotting diathesis)

Keywords: premature labor pre term labor intravenous fetal fibronectin
levonorgestrel-releasing intrauterine system and tubal ligation

Conditions: Tubal Ligation

Summary: today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. the percentage of women who use sterilization as a method of contraception rises from about 5% between 20 and 24 years of age to almost 50% for those between 40 and 44 years of age. the most widely touted and most significant health benefit of tubal sterilization appears to be a reduced risk of ovarian cancer. post-tubal ligation syndrome includes pain during intercourse, aching lower back, premenstrual tension syndrome, uterine hemorrhage, and absence of menstruation. the syndrome is caused by blood circulation problems in and around the fallopian tubes and ovaries, pressure on nerves, and intrapelvic adhesion. since the symptoms of this syndrome are mild, simple symptomatic treatment is sufficient in most cases. in some cases, however, hysterectomy may be necessary.


Eligibility criteria:
inclusion criteria: * women aged from 30-40 year * woman subjected to tubal ligation * women 12 month postpartum * non lactating women * nomedical disorders exclusion criteria: * contraindication for levonorgestrel-releasing intrauterine system * women with any uterine or ovarian pathology * women refuse to participate
different dosing strategies of colistin in multidrug-resistant gram-negative bacilli infections

Conditions: Critical Ill Patients; Multi Drug Resistant

Summary: nosocomial infections caused by multi-drug-resistant (mdr) and extensively drug-resistant (xdr) gram-negative pathogens represent a major threat worldwide. the increasing trend of multi-drug resistance in gram-negative bacteria (mdr-gnb) poses a particularly acute challenge to health systems especially in critically ill patients. patients in intensive care units (icus) have encountered an increasing emergence and spread of antibiotic-resistant pathogens. in saudi arabia mainly mdr-gnb such as acinetobacter baumannii, pseudomonas aeruginosa, klebsiella pnemoniae and enterobacter are observed in icus. polymyxins are the last line therapy in the treatment of infection caused by these mdr-gnb. colistin is the most widely used polymyxin antibiotic, it is administered as inactive prodrug colistimethate sodium (cms) that is hydrolyzed to an active moiety of colistin base activity (cba). it acts as cationic detergent and damages bacterial cytoplasmic membrane causing leaking of intracellular substances and then cell death. during the first years of their use, polymyxin-associated neurotoxicity occurred in patients with an incidence as high as 27% following parenteral administration. however, other retrospective clinical trials have not exposed neurotoxicity to be a major concern. on the other hand, nephrotoxicity is by far the most common and dose-limiting side effect associated with parenteral polymyxins, with incidence rates in patients as high as 60%. despite the high incidence of colistin induced nephrotoxicity, in 2012, the world health organization (who) reclassified polymyxins as critically important for the management of mdr-gnb infection, renewing the interest in these antibiotics. to the best of our knowledge no study compared the efficacy and safety of both dosing strategies in critically ill patients. moreover, there is still a lack of evidence on the efficacy and safety of both dosing strategies in obese patients. therefore, this study aims at comparing the efficacy and toxicity of both strategies in colistin dosing (the fixed dose and the weight-based dosing) in obese patients and non- obese patients.


Eligibility criteria:
inclusion criteria: * patients age ≥ 18 years old. * patients who will be treated with cms for mr gnb infections. * patients who are admitted to the icus. exclusion criteria: * known hypersensitivity to colistin. * pregnant and lactating women. * patients who are treated with colistin for \< 24 hours. * patients with myasthenia gravis or concomitant anesthetics or neuromuscular blocking drugs.
the biodistribution of 1-l-(2 deoxy-2,- 18 fluoroarabinofuranosyl) cytosine ([18f]l-fac) in healthy subjects and patients with cancer, autoimmune and inflammatory diseases

Conditions: Autoimmune Diseases; Cancer

Summary: the purpose of this study is to determine the biodistribution of a new agent 1-l-(2 deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate whether it can be used to image cancer, autoimmune disease, and inflammation


Eligibility criteria:
inclusion criteria: * greater than 18 years of age * women of childbearing potential will undergo a pregnancy test free of charge * patients with hematological malignancies, solid tumors or autoimmune disorders

Keywords: imaging probe cancer inflammatory tissue inflammatory diseases
a study of pariet to prevent gastric and duodenal ulcer associated with low-aspirin in korean participants with a history of gastric and duodenal ulcer

Conditions: Stomach Ulcer; Duodenal Ulcer

Summary: the purpose of this study is to understand the following safety related particulars associated with the use of pariet tablet 5 milligram (mg) to prevent gastric and duodenal ulcer from low dose aspirin administration of 100 mg or less daily in participants with a history of gastric and duodenal ulcer: 1. serious adverse events (saes) and adverse drug reactions (adrs) 2. unexpected adverse events (aes) and adrs not reflected in the precautions for use 3. known adrs 4. non-serious adrs 5. other safety and efficacy related information.


Eligibility criteria:
inclusion criteria: 1. participants aged over 18 years 2. participants who have a history of gastric and duodenal ulcer falling under the approved indication for pariet tablet 5 mg and who are receiving pariet tablet 5 mg to prevent gastric and duodenal ulcer from low dose aspirin use of 100 mg or less daily 3. participants whose prescription of pariet tablet 5 mg has been determined before study participation 4. participants who have given written consent to the use of their personal and medical information exclusion criteria: 1. participants with a known hypersensitivity to rabeprazole sodium, any excipients used in the formulation or benzimidazole derivatives, and with the history of such hypersensitivity 2. participants administered with atazanavir 3. pregnant or lactating 4. participants administered with rilpivirine 5. participants currently participating in other clinical trials