Kornimate/medical-research-clean huggingface dataset:
prospective randomized clinical trial of intravenous lipids and cholestasis

Conditions: Parenteral Nutrition Associated Cholestasis

Summary: the investigators hypothesize that increased cumulative amount of lipid intake causes pnac in late preterm and term neonates with major gi surgical disorders


Eligibility criteria:
inclusion criteria: all neonates ≥ 34 weeks gestational age with major gi surgical disorders (gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and gi perforations) requiring surgery admitted to our nicu within first 72 hours will be eligible for this study exclusion criteria: 1. if does not need tpn by 72 hours; 2. direct hyperbilirubinemia within the first 72 hours after birth; 3. torch infections (toxoplasmosis, cmv, herpes, rubella, hiv, etc); 4. biliary tract disorders leading to direct hyperbilirubinemia; 5. known metabolic disorders that may be associated with direct hyperbilirubinemia- such as galactosemia, α-1 antitrypsin deficiency, etc
an open-label extension study to evaluate the safety and tolerability of rwj 333369 as adjunctive therapy in patients 16 years and older with partial onset seizures.

Conditions: Epilepsy; Complex Partial Seizures; Epilepsy, Complex Partial; Epilepsies, Partial

Summary: the purpose of this open-label extension study is to demonstrate that rwj-333369 is safe as long-term add-on treatment of partial onset seizures.

333369epy3004 is the open-label extension study that follows the double-blind studies 333369epy3001 and 333369epy3002 (nct00425282 and nct00433667, respectively). in an open label study such as 333369epy3004, both the physician and the patient know the name of the assigned study medication. in a double blind study such as 333369epy3001 and 333369epy3002, neither the physician nor the patient knows the name of the assigned study medication. patients who complete the double-blind treatment phase of studies 333369epy3001 and 333369epy3002 will be eligible to enter the open-label extension study 333369epy3004 during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as rwj-333369). there will be a blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. no patients will receive placebo during the open-label extension. safety assessments include the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ecg) recordings, vital signs measurements, physical and neurologic examinations, the physician withdrawal checklist for symptoms of withdrawal for those patients who taper and/or discontinue study drug, and pregnancy tests for females of childbearing potential. seizure counts will be obtained at every visit. a quality of life in epilepsy questionnaire will be administered during the study. there is no statistical testing hypothesis for this study. detailed description update,5 oct 2009. the sponsor in conjunction with the dsmb agreed to amend the protocol to withdraw patients who develop signs of a drug hypersensitivity reaction. open-label treatment with carisbamate 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses bid for up to 1 year; study drug should be swallowed whole and not be chewed, divided, crushed, or dissolved.

Eligibility criteria:
inclusion criteria: * in order to enter the open label extension, the patient must have completed either study 333369epy3001 or study 333369epy3002. exclusion criteria: * generalized epilepsy * currently experiencing seizures that cannot be counted accurately * unstable medical disease, such as a recent heart attack or uncontrolled diabetes * major psychiatric illness * recent drug or alcohol abuse * unable to swallow pills

Keywords: rwj-333369 anticonvulsants antiepileptic drugs epilepsy, focal seizure disorder
evaluating etanercept use in patients with moderate to severe rheumatoid arthritis who have lost response to adalimumab

Conditions: Moderate to Severe Rheumatoid Arthritis

Summary: to evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (ra) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.


Eligibility criteria:
inclusion criteria: * able to provide informed consent * diagnosed with moderate to severe rheumatoid arthritis for at least 6 months * active ra with at least 3 swollen and tender joints * failure to respond to a combination treatment of adalimumab and methotrexate (must have taken combination at least 3 months) or loss of a satisfactory response to the combination of adalimumab and methotrexate, which was taken for at least 6 months (if currently taking adalimumab must complete 2 weeks without it prior to starting study drug) * negative for hepatitis b and c * negative serum and urine pregnancy tests before starting study * currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is permitted with documented intolerability * normal chest x-ray within 3 months * negative testing for tuberculosis (tb) exclusion criteria: * class iv ra (wheel-chair or bed-bound) * significant concurrent medical conditions, including: (uncontrolled type 1 diabetes, poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in past year, history of unstable angina within past year, uncontrolled hypertension, severe chronic pulmonary disease, major chronic inflammatory or connective tissue disease other than ra, multiple sclerosis, active malignancy, or history of cancer, alcoholic hepatitis or history of alcoholic liver disease) * other inclusion/exclusion criteria may apply

Keywords: rheumatoid arthritis etanercept arthritis adalimumab failure to respond loss of response to adalimumab acr20 methotrexate swollen joints tender joints
investigation of bacterial adhesion and bactericide effect ex vivo on different implant restoration materials

Conditions: Dental Diseases

Summary: investigation of bacterial adhesion and bactericide effect ex vivo on different implant restoration materials

the aim of this study is to investigate bacterial attachment and bactericidal effects of different materials used for the transmucosal part of implants. using a brace, the intraoral biofilm formation in healthy subjects will be measured after 28 hours (24 hours intraorally, 4 hours rest). for this purpose 2 sterile platelets of each of the 8 differently processed materials (16 platelets in total) are inserted into the braces. the main target parameter is the quantification of the biofilm by crystal violet staining. for this purpose the samples are analyzed by spectrophotometry at a wavelength of 595 nm (od595). as secondary target parameter possible bactericidal effects of the materials, which are analyzed by colony forming units (cfu) determination, are used.

Eligibility criteria:
inclusion criteria: * no systemic antibiotic therapy during the last 3 months * good oral hygiene and compliance (plaque index (pi) \<20%, bleeding index (bi) \<20%) * no signs of periodontitis or other inflammatory changes in surrounding tissues * non-smokers exclusion criteria: * disease that requires antibiotics * pressure points caused by the braces, which cannot be eliminated by adjusting * other unforeseen complications that can be associated with braces

Keywords: intraoral biofilm formation parodontitis tooth implant periimplant diseases
fatty acid metabolism and insulin sensitivity after exercise in obesity

Conditions: Obesity

Summary: alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after a single session of endurance exercise. the investigators will determine the effect of a single session of endurance exercise on whole-body fatty acid mobilization and oxidation, imtg concentration and the expression of factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity (age: 18-45y). in addition, the investigators will evaluate how these factors, and exercise, effect insulin signalling and insulin sensitivity. every effort will be made to recruit subjects from ethnic and minority groups. before participating in the study, subjects will be informed of all the procedures and potential risks, and they will sign an informed consent form approved by the university of michigan institutional review board. eligible volunteers will participate in three separate trials, in a randomized order. in two trials subjects will eat exactly the same amount of calories, except in one trial they will exercise (eucaloric + exercise) and in the other trial they will remain sedentary (hypercaloric). in a third trial subjects will again remain sedentary but instead they will ingest appropriate calories to maintain caloric balance (eucaloric + sedentary). by doing this the investigators are also able to investigate the effect of acute caloric perturbations on insulin sensitivity, because it is possible that the enhanced insulin sensitivity evident after exercise, as compared to the sedentary state, is due to caloric deficit and not the exercise bout, per se.


Eligibility criteria:
inclusion criteria: * premenopausal; body mass index 30-40 kg/m2; waist circumference \>88 cm exclusion criteria: * evidence of metabolic or cardiovascular disease; pregnancy; hyperlipidemia (fasting plasma triglyceride concentration \> 150 mg/dl); hematocrit \ 2 times/week)

Keywords: exercise fatty acid metabolism insulin sensitivity
a randomized,parallel-group clinical trial of hepatitis b vaccine with different dosages and schedules in healthy adults

Conditions: Hepatitis B

Summary: the objective of this study is to evaluate the immunogenicity and anti-hbv antibody persistence of hepatitis b vaccine with different doses and schedules. hepatitis b vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. furthermore, the safety of hepatitis b vaccine with different doses and schedules will also be evaluated.


Eligibility criteria:
inclusion criteria: * healthy subjects aged between 16 and 25 as established by medical history and clinical examination * written informed consent will be obtained from each subject before the serum screening of hbv markers * seronegative for hbsag, anti-hbs antibody, anti-hbc antibody * have never been immunized with hbv vaccine before exclusion criteria: * subject has a medical history of allergic to any ingredient of vaccine * family history of seizures or progressive neurological disease * autoimmune disease or immunodeficiency * women with pregnant * bleeding disorder diagnosed by a doctor * chronic diseases: hepatitis, tumor, tuberculosis,et.al * any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment * subjects had a medical history of serious adverse reactions to vaccines

Keywords: hepatitis b hepatitis b vaccine immunogenicity adults
transversus abdominis plane block for renal transplant recipients

Conditions: Disorder Related to Renal Transplantation; Pain

Summary: the purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the plane between the abdominal muscles in reducing the amount of pain relief required after surgery.

the aim of this study is to evaluate the efficacy of transversus abdominis plane block in reducing the morphine requirements after renal transplantation.

Eligibility criteria:
inclusion criteria: * renal transplant recipients * 18 to 75 years exclusion criteria: * allergy to local anaesthetics * chronic pain * refusal

Keywords: transversus abdominis plane block relief
a questionnaire to assess the quality of life of rectal cancer patients with or without stoma

Conditions: Rectal Cancer

Summary: the aim of the present prospective study was to evaluate the prediction accuracy of eortc qlq-c30/c38 questionnaire in rectal cancer patient(rc). this study was designed to investigate how the quality of life (qol) of patients with rectal cancer changes with time after cancer or after stomia. eligible subjects were consecutively enrolled in the investigators' institute and subjected to eortc qlq-c30/c38 questionnaire.

eligibility criteria: italian people with adenocarcinoma of rectum. exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy. outcome measures: patient was carried out using a eortc qlq-c30/c38 questionnaire.to determine how surgery affects qol, we divided patients into two groups: first rectal cancer submitted to rectal anterior resection(rar) and latter rectal cancer submitted to rectal anterior resection with stomia(rars). differences in qol between the two groups were analyzed during three time: first preoperative, second postoperative and latter six month later of after the stoma reconversion in rars patients

Eligibility criteria:
inclusion criteria: * rectal cancer exclusion criteria: * age younger than 18 years * history of psychiatric illness * preoperative radiotherapy

Keywords: quality of life
improving outpatient colonoscopy bowel prep with the orton score

Conditions: Colonic Polyp; Colon Cancer

Summary: colonoscopy is a common endoscopic procedure which the uva gastroenterology \& hepatology department performs on a daily basis for both screening/surveillance and diagnostic/therapeutic intent. as a safety net hospital, the institution also offers open access colonoscopy as a means of allowing outside primary care and urgent care providers a way to have patients receive necessary endoscopy services. however, these patients are not all seen in clinic prior to their procedure but are all prescribed a specific bowel prep by a medical professional who screens the referrals. given that the patient population described above are often not well-known to uva providers, they may be prescribed prep regimens that are not ideal for their comorbidities. not infrequently, these patients show up to their colonoscopies with an inadequate bowel prep, leading to either cancelled or incomplete procedures, increased healthcare and personal financial costs (such as missed wages from taking off work), suboptimal endoscopy resource utilization, and delay in or missed polyp (or potentially cancer) detection. the investigators seek to use a novel scoring system designed to predict patients at risk for suboptimal preps (and hence patients that would benefit from an extended prep) and apply it in uniform fashion to a patient population most at risk for suboptimal preps. because obtaining written consent is not practical given that these patients may not be seen by a uva provider prior to their endoscopic procedure, the investigators will plan to verbally consent via the telephone in an all-inclusive manner; there will be no randomization but rather the selection of prep to be determined by the novel scoring system. subjects be prescribed either a standard split-dose golytely prep (or suprep) or an extended split-dose golytely prep. the investigators predict that utilizing this new system will lead to a decreased number of inadequate bowel preps and will increase polyp detection. the investigators will work with a uva biostatistician to analyze the data and use chi square, student's t tests, and logistic regression models to assess significance and help validate the model.


Eligibility criteria:
inclusion criteria: * age 18 or older (up to 100 years) * referred for open access colonoscopy from an outside provider/uva provider * able to provide informed consent exclusion criteria: * prisoners

Keywords: colonoscopy bowel prep screening
trial of netarsudil for acceleration of corneal endothelial restoration

Conditions: Fuchs' Endothelial Dystrophy

Summary: subjects with fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.

subjects with fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered descemet membrane surgically removed. subjects will be randomized to use netarsudil or placebo eye drops once daily. visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.

Eligibility criteria:
inclusion criteria: * male or female patient at least 18 years of age and of any race or ethnicity who is undergoing descemet stripping only for fuchs dystrophy * is able and willing to administer eye drops * is able to comprehend and has signed the informed consent form. exclusion criteria: * active intraocular inflammation * corneal ulceration, keratitis, or conjunctivitis * known sensitivity to any of the ingredients in the study medications * abnormal eyelid function * history of herpetic keratitis * history of non-compliance with using prescribed medication * current or planned pregnancy within the study duration * concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study * any ocular or systemic condition (i.e., uncontrolled systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
clinical performance evaluation of ai-enabled automated gram staining device

Conditions: Infection, Bacterial

Summary: the investigators have developed an analysis ai for gram staining. in this study, the investigators will compare the testing accuracy of automated gram staining equipment with ai with the testing accuracy of laboratory technicians. based on the results, the investigators will examine the possibility of clinical application of the automated gram staining device.

gram staining,whitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases, is often manually performed in many laboratories, and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians. automating the entire process from staining to microscopic examination, as achieved by the ai-equipped automatic gram staining device, can reduce the labor required for gram staining. this automation enables even less experienced technicians to quickly report gram staining results. the aim of this study is to evaluate the accuracy of the auto microscopic examination of gram-stained samples using anonymized processed slides created from clinical specimens. this evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians. if the accuracy of the machine is demonstrated, it can be registered as a medical device and proceed to the implementation stage in actual clinical settings. the implementation of this device in clinical laboratories is expected to reduce workload, expedite processes, and contribute to the optimization of antibiotic use based on gram staining results.

Eligibility criteria:
inclusion criteria: 1. patients in whom a gram stain test was ordered exclusion criteria: no exclusion criteria
long-term effects of lifestyle intervention in obesity and genetic influence

Conditions: Obesity; Cardiovascular Risk

Summary: the purpose of the study is to determine the genetic influence on short-, middle- and longterm effects of an inpatient lifestyle therapy program in overweight and obese children and adolescents.

in germany, as in other countries, overweight and obesity affects a growing number of children and adolescents. obesity-related diseases such as arterial hypertension, disorders of glucose and lipid metabolism and an increase in inflammation markers are associated with higher morbidity and mortality in early life, therefore effective therapy concepts are needed. the aim of this study is to evaluate the effects of a 4-6 week inpatient obesity lifestyle therapy program over 10 years and the genetic influence on the short-, middle- and longterm outcome. the lifestyle intervention consists of physical exercise, nutrition education and behaviour therapy based on the criterions developed by the german obesity group (degree of weight reduction, improvement of comorbidity and health behaviour, minimising of side effects).

Eligibility criteria:
inclusion criteria: * overweight or obese children (bmi \>90th percentile for age and gender), who obtained an inpatient lifestyle intervention in the participating clinic. * children with written consent from their parents and the acceptance of a 10-year follow-up. exclusion criteria: * children without written consent from their parents. * children with monogenetic diseases with influence on obesity (e.g. prader-willi-syndrome) or with secondary obesity.

Keywords: obesity overweight childhood adolescence inpatient therapy lifestyle intervention cardiovascular risk gene-lifestyle-interaction obesity and associated cardiovascular risk in childhood and adolescence, health behaviour
clinical trial to evaluate the effect on the pharmacokinetic characteristics of hcp1007 capsule

Conditions: Healthy

Summary: the purpose of this study is to evaluate pharmacokinetics and safety after oral administration of hcp1007 capsules and rosuvastatin plus omega-3.

the purpose of this study is to evaluate pharmacokinetics and safety after oral administration of hcp1007 capsules and rosuvastatin plus omega-3.

Eligibility criteria:
inclusion criteria: * healthy male volunteers, age between 20 and 45 * informed of the investigational nature of this study and voluntarily agree to participate in this study * bmi of \>20kg/m2 and \<26kg/m2 subject exclusion criteria: * use of any prescription medication within 14 days prior to day 1 * use of any medication within 7 days prior to day 1 * participation in another clinical study within 60 days prior to start of study drug administration

Keywords: hcp1007 rosuvastatin omega-3
french national cohort of children with port wine stain

Conditions: Port Wine Stain; Klippel Trenaunay Syndrome; Parkes Weber Syndrome

Summary: port wine stain on a limb can be either isolated or associated with complications (venous or orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes (klippel-trenaunay syndrome,parkes-weber syndrome). little is known about epidemiology of port wine stains: their evolution during the growth of the child, the frequency of complications, genetic data, and prognostic factors. this prospective french national cohort will help for : description of the evolution of port wine stain and possible complications; prognostic factors for complications ; association with mutations of rasa1 gene; quality of life of these children. it will also help for global appreciation of the management of this disease in france.

prospective national study, including 16 pediatric and dermatologic departments. methods : each children with a port wine stain on a lower limb will be followed up for 5 years. collected data : demographic data, clinical features, alterations of rasa1 gene, vascular evaluation by ultrasonographic and orthopedic evaluation by x rays, quality of life with a questionnaire. inclusion period = 3 years follow up period = 5 years population = 150 children

Eligibility criteria:
inclusion criteria: * child between 2 and 12 years old with a port wine stain on a lower limb ( or two lower limbs) with national health assurance with consent from one parent exclusion criteria: * child with orthopedic impairment with no link with the port wine stain

Keywords: port wine stain of a limb