Kornimate/medical-research-clean huggingface dataset:
immunogenicity and reactogenicity of fluarix™ (influsplit ssw®) 2007/2008 in people 18 years old or above

Conditions: Influenza

Summary: this study is designed to test the immunogenicity and reactogenicity of the fluarix™/influsplit ssw® containing the influenza strains recommended for the 2007-2008 season.


Eligibility criteria:
inclusion criteria: * healthy male or female aged 18 years or above; * non-childbearing or using adequate contraception; * written informed consent obtained from the subject. exclusion criteria: subjects must not: * participate in a trial or using non-registered product; * use immunosuppressants, blood products, or another influenza vaccine during study; * have virologically confirmed influenza within 1 year; * have allergic or acute disease; * have unstabilized serious chronic disease; * be a lactating female.

Keywords: flu vaccine
comparison of three electroconvulsive therapy (ect) techniques for the treatment of major depression

Conditions: Depression

Summary: this study will compare the antidepressant benefits and cognitive side effects of three different types of electroconvulsive therapy (ect) in people with unipolar or bipolar depression.

ect is an important treatment for severely depressed people who do not respond adequately to, or are intolerant of, antidepressant medication. traditionally, ect has been administered with one of two standard techniques: bilateral and right unilateral electrode placement. however, these techniques are limited by either low efficacy or high cognitive impairment. recently, an additional technique for ect administration has shown promise in preliminary studies: bifrontal ect. this study will compare this technique to the two traditional ect techniques in treating people with depressive symptoms. participants in this study will be randomly assigned to receive standard bilateral ect, high-dose right unilateral ect, or bifrontal ect in their index course. depression symptoms, neuropsychological status, and quality of life will be measured throughout the course of the ect treatment, one week after, and at a 2-month follow-up visit. this study will run for 4 years.

Eligibility criteria:
inclusion criteria: * diagnosis of unipolar or bipolar depression

Keywords: bipolar disorder
an open study to evaluate the sustained effect in patients showing virological responses with muscle-related symptom of chronic hepatitis b patients who received clevudine

Conditions: Chronic Hepatitis B

Summary: an open study to evaluate the sustained effect in patients showing virological responses with muscle-related symptom of chronic hepatitis b patients who received clevudine.


Eligibility criteria:
inclusion criteria: 1. patients is currently clevudine treatment. 2. patients with hbv dna \< 300 cpoies/ml and alt normal showing muscle-related symptom who received clevudine 3. patient who is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. 2. patient is pregnant or breast-feeding. 3. patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except hcc)or allergic disease. 4. patient, in the opinion of the investigator, unsuitable for the study. 5. showing muscle-related symptom who any other evidence.
a randomized controlled trial of a video decision making aid to obtain informed consent in the surgical intensive care unit

Conditions: Surgery; Trauma

Summary: to demonstrate that clinical surrogates of sicu patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the sicu make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.

specific aim 1: to demonstrate that clinical surrogates of sicu patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the sicu make more informed decisions than patients and clinical surrogates who receive written and verbal information alone. hypothesis 1: adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the sicu, will better inform clinical surrogates of incapacitated patients admitted to the sicu regarding decision making when providing consent for medical treatment.

Eligibility criteria:
inclusion criteria: * clinical surrogates of the following patients will be eligible to participate in this opinion survey: 1. all patients admitted to the sicu and not expected to die within 48 hours. 2. patient has been admitted to the acute care surgical service, 3. the patient is over the age of 50 and does not have decision making capacity. * subjects must be over the age of 21 and english speaking to participate in the opinion survey. exclusion criteria:
a patient reported ocular comfort assessment comparing bepreve to lastacaft

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the comfort of bepreve compared to lastacaft after instillation.

after one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.

Eligibility criteria:
inclusion criteria: each patient must meet the following criteria to be enrolled in this study: 1. are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis. 2. have allergic ocular symptoms within the last three days. 3. are willing/able to follow instructions from the study investigator and his/her staff. 4. have signed informed consent approved by institutional review board or independent ethics committee. exclusion criteria: patients who meet any of the following criteria will be excluded from the study: 1. have known hypersensitivity to either bepreve™ or lastacaft® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.). 2. have active corneal pathology noted in the study eye at the screening visit. active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. 3. are pregnant or nursing/lactating.
predictive value of embryonic testing

Conditions: Infertility

Summary: the primary objective of this study is to determine the predictive value of preimplantation genetic screening (pgs) as a marker of embryonic competence. secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in assisted reproductive technology (art) cycles.

patients participating in the study will undergo a routine in vitro fertilization cycle. trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be analyzed till the clinical outcome has been determined. the single, morphologically best embryo available will be selected for transfer. all clinical and laboratory care is identical to that of which subjects would receive if they were not participating in the study. this includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).

Eligibility criteria:
inclusion criteria: 1. couples electing embryonic aneuploidy screening (pgs) 2. couples electing single embryo transfer exclusion criteria: 1. any prior failed ivf cycle 2. diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid 3. diagnosis of chronic endometritis 4. maximum day 3 fsh level of 12 or higher 5. anti-mullerian hormone level less than 0.5 g/ml, tested within previous year 6. total basal antral follicle count less than 8 follicles 7. male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) 8. bmi \ 35 9. personal history of recurrent pregnancy loss (two or more pregnancy losses) 10. use of oocyte donation 11. use of gestational carrier 12. medical condition predisposing patient to high risk pregnancy 13. use of surgical procedures to obtain sperm 14. presence of hydrosalpinges that communicate with endometrial cavity 15. any contraindications to undergoing in vitro fertilization or gonadotropin stimulation 16. single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
effycacy of rifaximin on reverse minimal hepatic encephalopathy and elimation small intestinal bacterial

Conditions: Small Intestinal Bacterial Overgrowth; Liver Cirrhosis

Summary: a total of 46 patients diagnosed with liver cirrhosis will be recruited. all patients will be evaluated with five psychometric tests and critical flicker frequency to diagnosis minimal hepatic encephalopathy (mhe). a breath test sample will be performed in all patients with mhe with 10 g of lactulose to establish the diagnosis of small intestinal bacterial overgrowth (sibo). patients diagnosed with ehm and sibo will be randomized to receive per day 1200 mg of rifaximin (group a) or placebo (group b) for 2 weeks. a complete medical history, nutritional assessment, biochemical studies, and evaluation of quality of life will be performed in all patients included in the study. besides the initial visit, patients will receive subsequent care 2, 4, 8, 12, and 24 weeks after the beginning of the study.

mhe impairs the quality of life, increases the risk of motor vehicle accidents, and mortality. currently, there is no consensus on treatment and yet there are few proven treatment options. among the factors associated with mhe, is the small intestinal bacterial overgrowth (sibo) present in 38.6% of patients with mhe. rifaximin is a broad spectrum antimicrobial administered orally, with low risk of inducing bacterial resistance, and has been used in the treatment of mhe. it is unknown if the beneficial effect on mhe is associated with the elimination of sibo and its efficacy when administered in patients with simultaneous diagnosis of mhe and sibo was never been evaluated. the aim of our study is to evaluate the effect of rifaximin on mhe and sibo in patients with cirrhosis.

Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis of any etiology * men and women between 18 and 70 years. * patients diagnosed with minimal hepatic encephalopathy and small intestinal bacterial overgrowth * right-holders of the mexican social security institute * patients who agree to participate in the study and signed the informed consent exclusion criteria: * recent history of alcohol abuse and/or drugs (less than 6 weeks). * illiterate * alcoholic cirrhosis * history and/or diagnosis of overt hepatic encephalopathy * consumption of psychotropic medications (benzodiazepines, antiepileptics) * patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements. * history of chronic renal disease or heart failure * patients with gastrointestinal bleeding * history of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests * patients with diarrhea * diagnosis of liver cancer * patients with ophthalmologic disorders * patients taking antibiotics 30 days before the study

Keywords: rifaximin minimal hepatic encephalopathy
cardiac and renal disease study (cards)

Conditions: Coronary Disease; Cardiovascular Diseases; Cerebrovascular Accident; Heart Failure; Heart Diseases; Peripheral Vascular Diseases; Diabetes Mellitus; Hypertension; Kidney Failure, Chronic

Summary: to examine the epidemiology of renal disease and its relationship to cardiovascular disease.

background: mild-to-moderate chronic renal insufficiency (cri) has been reaching epidemic proportions in the united states. studies relating mild-to-moderate chronic renal insufficiency and cardiovascular risk were limited and inconsistent. although much had been learned about the natural history and adverse outcomes associated with end-stage renal disease (esrd), there was little specific information regarding risk factors for the development or progression of renal disease. the study was initiated in response to a request for applications entitled "nhlbi innovative research grant program" released in july, 2001. the purpose of the initiative was to support new approaches to heart, lung, and blood diseases and sleep disorders that used existing data sets or existing biological specimen collections whether obtained through national heart, lung, and blood institute support or not. design narrative: the population-based study used data on an ethnically diverse large cohort of male and female health plan enrollees with extended follow-up. the study evaluated: a) whether baseline and decline in renal function over time were independent predictors of coronary heart disease (chd), stroke, heart failure and peripheral vascular disease; b) effect modifiers of these relationships,including baseline hypertension and diabetes status. the study determined whether baseline and increase over time in blood pressure level (as well as prevalent and incident hypertension) were predictive of the subsequent risk of esrd after adjusting for diabetes and for baseline serum creatinine, proteinuria and hematuria. the study also examined other potential predictors of esrd including demographic factors (race/ethnicity, level of education) total cholesterol level, family history of renal disease, body mass index, sagittal abdominal diameter, cigarette (as well as cigar and pipe) smoking, coffee intake, alcohol consumption, family history of renal disease and self-reported occupational exposures. the study used existing longitudinal data resources at the northern california kaiser permanente division of research and available patient-level cross-linkage with the us renal data system end-stage renal disease registry to obtain comprehensive renal and cardiovascular outcomes. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
cytokines, pod, health status, older hip fracture

Conditions: Postoperative Delirium; Hip Fracture Surgery; Older People

Summary: an investigation of the change in inflammation marker levels across hip fracture surgery and an exploration of any association with change in self reported health status and incidence of postoperative delirium


Eligibility criteria:
inclusion criteria: * age ≥ 65 years old * admitted for primary hip fracture surgery exclusion criteria: * preoperative cognitive impairment * history of neurosurgery, neurologic diseases or head trauma * current systemic bacterial or viral infection * complex or multiple injuries

Keywords: postoperative delirium older people cytokines self-reported health status
developmental epidemiological study of children born through reproductive technology

Conditions: Infertility; Infertility, Female; Infertility, Male; Infertility Primary; Infertility Secondary; Infertility Unexplained

Summary: descrt will be a long-term study that both looks back in time, at successful pregnancies, and forward in time at early pregnancy and long-term as these children grow. currently, there are limited data on the long-term effects of infertility and infertility treatments on children. there are some studies to suggest that these children may have altered metabolic profiles, but this study aims to be the largest study to answer this question.

over the past 30 years, much of the research and clinical effort in the field of art had to do with improving outcome in terms of successful pregnancy. however, as these rates have increased, attention is slowly turning to focus on the health of the resultant child. short-term health complications, in particular birth defects,have been well-described. however, even this "hard" outcome has been difficult to characterize as studies used different methodologies, varied age of detection, and frequently didn't have an appropriate comparison group. when underlying parental factors and infertility are included in the analyses, the association is substantially weakened or disappears completely. this exemplifies the problems with much of the currently available research regarding childhood outcomes following art. while the health of children born through these technologies is of critical public health interest, and of personal interest to families, only limited data exist. in order to evaluate the potential risk to long-term health of children conceived through assisted reproductive technologies (art) and non-ivf fertility treatments (nift), rigorous epidemiological methods, appropriate characterization of the exposure, standardized collection of outcome data, and appropriate comparison groups are required. the proposed developmental epidemiological study of children born through reproductive technology (descrt) is aimed to carefully address these important characteristics.

Eligibility criteria:
retrospective arm inclusion criteria: - children conceived by parent(s) who sought evaluation/treatment for infertility exclusion criteria: - children with chronic medical illnesses that prevent a study visit prospective arm inclusion criteria: - seeking evaluation/treatment for infertility exclusion criteria: - none
phase ii study of gemcitabine versus s-1 adjuvant therapy after hemihepatectomy for biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: to compare efficacy and safety of gemcitabine versus s-1 adjuvant therapy after hemihepatectomy.

there is no standard adjuvant therapy after liver hemi-hepatectomy due to bile duct cancer, because of high surgical morbidity ratio and high adverse event ratio of adjuvant therapy. for example, our preliminary results showed that regular gemcitabine administration (1000mg/m2, day 1, 8, 15 every 4 weeks) after hemihepatectomy was too toxic and induced severe leukocytopenia and/or thrombocytopenia. formerly, the investigators planned the study to decide more safety adjuvant protocol (recommend dose: rd) for gemcitabine or s-1 after hemihepatectomy using continuous reassessment method (crm) analysis and decided the recommend doses. note: in the former study, the investigators decided that tolerable ratio of dose limiting toxicity (dlt) would be less than 10%. herein, the investigators planned the study to evaluate efficacy (recurrent free survival as primary outcome, and overall-survival as secondary outcome) and safety (as secondary outcome) in our recommended protocols, and to compare the efficacy as randomized control trial.

Eligibility criteria:
inclusion criteria: 1. biliary tract cancer (btc) (\>= unio internationalis contra cancrum (uicc) stage ib), adenocarcinoma 2. r0 or r1 resection 3. no obvious recurrent lesion 4. 20 years old or more 5. eastern cooperative oncology group (ecog) performance status must be 0 or 1 6. the patient underwent no other treatment than surgery for btc 7. neutrophil must be over 1500/μl, hemoglobin must be over 9.0g/dl, platelet must be over 100,000/μl, aspartate transaminase (ast) and alanine aminotransferase (alt) must be less than 150 iu/l, total bilirubin must be less than 1.5 mg/dl, creatinine must be less than 1.2 mg/dl, and creatinine clearance must be over 60 ml/min 8. the patient can intake drugs per os. 9. from 4 to 12 weeks after the surgery 10. written informed consent exclusion criteria: 1. existence of active double cancer 2. the patient suffered from severe drug allergy 3. sever complications (interstitial pneumonia, heart failure, renal failure, liver failure, ileus, incontrollable diabetes mellitus, and so on) 4. any active infections exist. 5. pregnancy 6. severe mental disorder 7. others
feasibility study: evaluation of the ulthera® system for treatment of the décolleté

Conditions: Skin Laxity of the décolleté

Summary: up to 20 subjects will be enrolled. subjects will receive treatment of the décolleté using the ulthera® system. subjects will be return for follow-up visits at 90 and 180 days post-treatment. the study will evaluate the effectiveness of the ulthera® system to lift and tighten the skin of the décolleté region.

this is a prospective, single-center study. baseline fabi/bolton 5-point chest wrinkle scale scores and chest measurements will be assessed prior to study treatment. study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Eligibility criteria:
inclusion criteria: * female, aged 35 to 60 years. * subject in good health. * moderate to severe (grade of ≥3 on fabi/bolton scale) skin laxity on the décolleté. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * scarring in areas to be treated. * tattoos in the areas to be treated. * patients with ports or defibrillators. * breast size \>400cc each as measured by water displacement method. * history of breast reduction surgery. * any open wounds or lesions in the area. * active and severe inflammatory acne in the region to be treated. * patients who have a history with keloid formation or hypertropic scarring

Keywords: ulthera® system ultherapy™ treatment ulthera, inc. ultrasound treatment for skin tightening
peg by introducer method via eg scan

Conditions: Dysphagia; Aspiration; Esophageal Stenosis

Summary: percutaneous endoscopic gastrostomy(peg) by introducer method has been proven to be safe and easy to perform. however, it is limited by its need to be performed in an endoscopy unit. e.g. scantm is an new portable ultrathin endoscope, capable of being performed in any hospital setting and introduced via nasal approach. our aim is to prove that peg by introducer method via e.g. scantm is feasible and safe. this will allow peg to be done at hospitals and medical facilities without endoscopic units.


Eligibility criteria:
inclusion criteria: * require percutaneous endoscopic gastrostomy placement due to inability to achieve oral feeding for at least one month exclusion criteria: * patients with esophageal ulcers or strictures * patients with prior esophageal/gastric surgery (excepting gastric wedge resection) * patients at high risk of gastric bleeding, mechanical ileus or gastrointestinal perforation * other patients in whom the study investigators consider unfit for inclusion

Keywords: percutaneous endoscopic gastrostomy introducer method