Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of the zoster vaccine gsk1437173a in elderly subjects

Conditions: Herpes Zoster

Summary: based on the results of a previous clinical phasei/ii study, gsk1437173a is the lead gsk candidate herpes zoster (hz) vaccine to prevent episodes of hz (shingles). this phase ii study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 \& 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the zoster-003 primary study onwards. the aim of the primary 108494 study is to evaluate the immunogenicity \& safety of different dosages of the gsk1437173a vaccine in healthy elderly population. the study population will be stratified by age. the primary objective of this trial is to select the best dosage of gsk1437173a. the aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate hz vaccine during a long term period. no new subjects will be enrolled during the extension phases of the study.

the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a male or female aged 60 years or older at the time of the first vaccination. * written informed consent obtained from the subject exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed. * administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection. * previous vaccination against hz. * history of herpes zoster (shingles). * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator. * administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period. * history of or current drug and/or alcohol abuse.

Keywords: gsk biologicals herpes zoster (hz) vaccine varicella zoster virus (vzv) shingles
alterations in muscle after total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the overall goals of this work are: 1) to elucidate alterations in gene expression and downstream protein synthesis 2 weeks after total knee arthroplasty (tka) to better explain quadriceps muscle atrophy after tka and 2) understand the mechanisms responsible for improved maintenance of muscle strength with neuromuscular electrical stimulation (nmes) utilization. furthermore, this investigation seeks to expand previous findings regarding attenuation of strength and functional performance deficits with nmes application to better understand how altered gene expression influences muscle function.


Eligibility criteria:
inclusion criteria: * 50 to 75 years of age * scheduled for unilateral tka at university of colorado hospital * diagnosed with osteoarthritis * cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study exclusion criteria: * neurological, vascular or cardiac problems that significantly limit function * bmi \> 35 * testosterone supplementation * pregnancy * anticoagulant therapy

Keywords: total knee arthroplasty (tka) gene expression
using surveys to examine the association of exposure to ml mortality risk predictions with medical oncologists' prognostic accuracy and decision-making

Conditions: Oncology

Summary: nearly half of cancer patients in the us will receive care that is inconsistent with their wishes prior to death. early advanced care planning (acp) and palliative care improve goal-concordant care and symptoms and reduce unnecessary utilization. a promising strategy to increase acp and palliative care is to identify patients at risk of mortality earlier in the disease course in order to target these services. machine learning (ml) algorithms have been used in various industries, including medicine, to accurately predict risk of adverse outcomes and direct earlier resources. "human-machine collaborations" - systems that leverage both ml and human intuition - have been shown to improve predictions and decision-making in various situations, but it is not known whether human-machine collaborations can improve prognostic accuracy and lead to greater and earlier acp and palliative care. in this study, we contacted a national sample of medical oncologists and invited them complete a vignette-based survey. our goal was to examine the association of exposure to ml mortality risk predictions with clinicians' prognostic accuracy and decision-making. we presented a series of six vignettes describing three clinical scenarios specific to a patient with advanced non-small cell lung cancer (ansclc) that differ by age, gender, performance status, smoking history, extent of disease, symptoms and molecular status. we will use these vignette-based surveys to examine the association of exposure to ml mortality risk predictions with medical oncologists' prognostic accuracy and decision-making.


Eligibility criteria:
inclusion criteria: * medical oncologists who treat lung cancer exclusion criteria: * medical oncologists who do not see lung cancer patients
energy drinks & driving ability

Conditions: Driver Sleepiness

Summary: rationale: sleepiness behind the wheel is the cause of many traffic accidents. it is claimed that a 15-minute break and consuming an energy drink such as red bull® energy drink counteracts driver sleepiness. objective: the objective of this study is to compare driving simulator performance after (1) a 15-minute break with placebo, (2) a 15-minute break with red bull® energy drink, and (3) continued driving. study design: a double-blind, placebo-controlled crossover study. study population: healthy human volunteers, 21-35 years old. intervention: each subject performs 3 test days: 1. 4 hours continued driving 2. 2 hours driving, a 15-minute break + red bull® energy drink, followed by 2 hours driving 3. 2 hours driving, a 15-minute break + placebo, followed by 2 hours driving main study parameters/endpoints: standard deviation of lateral position (sdlp), i.e. the weaving of the car.


Eligibility criteria:
inclusion criteria: * he/she is aged between 21 and 35 years old * bmi between 21 and 30, * 55-85 kg body weight * non smoker * written informed consent * normal static binocular acuity, corrected or uncorrected * normal hearing * possession of a valid driver's license for at least 3 years * regular driver (\> 5000 km / year) * be considered as reliable and mentally capable of adhering to the protocol. exclusion criteria: * current drug use (positive urine drug screen on the presence of amphetamines (including mdma), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test * use of psychoactive medication * pregnancy * positive alcohol breath test * prior enrolment in the same study * physical or mental illness * excessive alcohol use (\>21 alcoholic drinks per week) * intake of caffeine-containing beverages under 2 or over 4 glasses per day * regular consumption of energy drinks (\>1 per month) * shift worker (or no regular sleep pattern) * epworth sleepiness score (ess) \> 10

Keywords: sleepiness driving
heart rate variability in chronic kidney disease patients

Conditions: Chronic Kidney Disease; Heart Rate Variability

Summary: use 24hr holter ecg, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients

24hr holter examination is a non-invasive tool in detecting and diagnosing cardiac arrhythmia. moreover, heart rate variability has been proven to been an important prognostic factor in many cardiovascular diseases. the traditional linear analysis of heart rate variability proved to predict clinical outcome in myocardial infarction patients. the more delicate non-linear analysis in heart rate variability is one of the hot topics in the world. despite some biochemical values like wbc counts, platelet counts, bun, creatinine, lactate, clinical vital parameters like blood pressure, heart rate, and oxygenation have been used to predict clinical outcome in chronic renal disease(ckd) patients, the application is still limited. it is an international interest to find a more safe and simple technique to identify important prognostic factors in ckd patients. our project aimed to recruit these ckd patients from our hospital and conduct a cross-sectional study. cardiac ultrasonography and 24hrs holter will be arranged. linear and non-linear analysis of heart rate variability will be performed and serum marker that influence prognosis like wbc count, platelet count, lactate, bun, creatinine, fibrosis marker and adiponectin will be checked. short term and long term outcome was followed and identify important prognostic factors to improve and detect clinical prognosis.

Eligibility criteria:
inclusion criteria: * peritoneal dialysis more than 3 months exclusion criteria: * pregnancy 2. received ct in recent 3 months

Keywords: heart rate variability autonomic function heart function
the research of standard diagnosis and treatment for hspn in children

Conditions: Henoch-Schoenlein Purpura Nephritis

Summary: this study is performed to evaluate the efficacy and safety of various measures in the treatment of hspn in children.

henoch-schonlein purpura nephritis (hspn) is one of the most common complications of henoch-schonlein purpura, and has become one of the main causes of chronic kidney disease in children. however, the diagnosis and treatment of hspn is still based on the clinical experience, lacking of evidence-based support. this study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of hspn in children. the patients who are proved to get hspn by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.

Eligibility criteria:
inclusion criteria: * renal biopsy proved hspn proteinuria ≥ 50 mg/kg/d exclusion criteria: * the children with congenital diseases proteinuria \< 50 mg/kg/d
safety and viability of an e. coli nissle colibactin knockout in healthy volunteers

Conditions: Diabetes

Summary: e. coli nissle (ecn) is a well-established human probiotic. however, it has been found that it produces colibactin, linked to colorectal cancer. in this safety trial, the safety and properties of a novel, colibactin-knockout ecn strain (ecnδclbp) is investigated.

in this randomised controlled intervention study, the investigators will compare ecn vs. ecn colibactin-knockout (ecnδclbp), given once daily for 7 days, in a population of healthy individuals. safety will be established using adverse event reporting, study visits and laboratory parameters. pharmacokinetics will be established at the beginning and the end of the study. ecn/ecnδclbp gut engraftment properties and effects on gut microbiome composition will be assessed using fecal analyses (qpcr, shotgun metagonmics). in addition, effects on glucose homeostasis will be studied using continuous glucose monitoring.

Eligibility criteria:
inclusion criteria: * healthy male or female of caucasian descent * if female, postmenopausal * age: 18-65 years old * bmi: 18-25 kg/m2 * subjects should be able to give informed consent exclusion criteria: * use of any systemic medication (except for paracetamol), including proton pump inhibitors, antibiotics and pro-/prebiotics in the past three months or during the study period. * use of the ecn probiotic strain (mutaflor®) in the past 12 months. * (expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency viruses (hiv) infection with a cd4-t cell count \< 240/mm3). * history of moderate to severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools/day for \>4 weeks), chronic obstipation (\ 3 months), irritable bowel syndrome (ibs) (according to rome iv criteria) or inflammatory bowel disease (ibd). * any gastro-intestinal disorder within the past 6 months * smoking or illicit drug use (e.g. amphetamine/cocaine/heroin/ghb) in the past three months or use during the study period. * use of \>21 units of alcohol per week on average in the past three months or use of \>2 units of alcohol during the study period. * simultaneous participation in other studies

Keywords: advanced microbiome therapeutics diabetes safety
hepaxa management of non-alcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; NASH - Nonalcoholic Steatohepatitis

Summary: this study measures the steatosis in patients with fatty livers as determined by cap score from a fibroscan assessment. the study attempts to determine the effect of using the medical food hepaxa in a clinical setting close to real-world use.

subjects with fatty liver are given hepaxa for 6 months. fibroscan cap measurements are taken at 3 monthly intervals. subjects consent to collection of data from approximately 6 months prior to use of hepaxa. patients unresponsive to life style recommendations given as standard practice will be enrolled.

Eligibility criteria:
inclusion criteria: 1. men or women, ≥18 years of age. 2. suspicion of nafld 3. able to understand and cooperate with study procedures, and have signed a written informed consent prior to any study procedures. 4. cap score at -6 months and at inclusion of \>268 5. a fibroscan elastography score \<9 kpa (advanced fibrosis) exclusion criteria: 1. other causes of liver inflammation including hepatitis a, b or c, hiv, confirmed or suspected cirrhosis, wilson's disease, autoimmune hepatitis, hemochromatosis, alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause liver damage, or known to be hepatotoxic. 2. significant weight loss (\> 5% body weight) or rapid weight loss (\>1.6 kg/week), within six months of screening. 3. individuals taking prescription or supplemental omega-3 fatty acids. 4. has a condition the investigator believes would interfere with the evaluation of the subject, or may put the subject at undue risk during the course of the study, including potentially abnormal lab results, due to a traumatic event.

Keywords: omega-3 nafld nafl nash medical food
analysis of b cells from autoimmune individuals

Conditions: Lupus Erythematosus; Rheumatoid Arthritis; Type 1 Diabetes

Summary: this observational study aims at finding out if individual with autoimmunity exhibit increased numbers of b cells that express two types (instead of one type) of antibodies, and if b cells of individuals genetically susceptible to autoimmunity display defects in the biological process of tolerance, which removes b cells that participate in autoimmunity.

peripheral blood b cells of sle patients are analyzed by flow cytometry to determine the frequency of b cells co-expressing immunoglobulin kappa an lambda light chains. this frequency is correlated to the disease activity.

Eligibility criteria:
inclusion criteria: * adult males and females diagnosed with lupus; * adult females who are pregnant and diagnosed with: * lupus erythematosus * rheumatoid arthritis, or * type 1 diabetes. exclusion criteria: * adult males or adult females treated with b-cell depletion therapies.
13-valent pneumococcal conjugate vaccine study in adults and children in india

Conditions: Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC

Summary: this study is to describe the safety and immunogenicity of 13vpnc in indian adults 50 to 65 years of age and in indian children 6 to 17 years of age.


Eligibility criteria:
inclusion criteria: indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vpnc vaccination. exclusion criteria: any contraindication to 13vpnc vaccination, vaccination with any pneumococcal vaccine within the last year

Keywords: 13-valent pneunococcal conjugate vaccine pneumococcal disease prevention; safety and immunogenicity study
can the ergometric test in flu-like syndrome help in the outcome analysis of unvaccinated patients

Conditions: Flu-like Syndrome; FLU; Flu-like Symptoms; Vaccination

Summary: during the flu-like syndrome, the cardiovascular risk is increased, especially in the elderly. understanding whether blood pressure assessment during an exercise test can aid in the understanding of patient outcomes, thereby improving prognostic ability in clinical practice, is the focus of the present study. therefore, the aim of this study is to evaluate the hemodynamic response of adults with flu-like symptoms, both vaccinated and unvaccinated, and to conduct a 30-day follow-up for assessment. patients who are indicated for an ergometric test and present with flu-like syndrome will be selected. we will inquire about their vaccination history and perform the ergometric test to evaluate test duration, arrhythmias, and ischemias


Eligibility criteria:
inclusion criteria: * flu-symptoms exclusion criteria: * recent orthopedic surgery
precision-targeted transcranial magnetic stimulation in the treatment of primary dystonia

Conditions: Primary Dystonia; Transcranial Magnetic Stimulation

Summary: in this scheme, tms treatment of primary dystonia is planned by precise magnetic resonance positioning.


Eligibility criteria:
inclusion criteria: * primary dystonia exclusion criteria: * none
double osteotomy for deformity correction in pyle disease

Conditions: Pyle Disease

Summary: leg deformity is one of the features of pyle disease( metaphyseal dysplasia). correction of valgus deformity of the leg can be done after deformity analysis by double osteotomy so this study showed how double osteotomy can lead to better results than single osteotomy.


Eligibility criteria:
inclusion criteria: * pyle disease exclusion criteria: 1. smoking 2. diabets mellitus 3. previous surgery on the limbs

Keywords: pyle disease genu valgus double osteotomy deformity analysis functional outcome
fmiso pet/ct imaging trial for assessing hypoxia in soft tissue sarcomas

Conditions: Soft Tissue Sarcoma

Summary: subjects with known or suspected primary soft tissue sarcoma of the extremities may be eligible for this study. subjects may participate in this study if they are at least 18 years of age. most participants will be receiving care at the clinical practices of the university of pennsylvania health system. positron emission tomography (pet/ct) imaging will be used to evaluate soft tissue sarcoma hypoxia using an investigational radiotracer, 18f-fmiso subjects will also undergo an 18f-fdg pet/ct scan close to the time of their initial hypoxia pet/ct to compare in vivo measures of hypoxia to 18f-fdg uptake. the fdg pet/ct may be performed as part of standard clinical care or as a research scan. both pet/ct scans will occur prior to starting new therapy.


Eligibility criteria:
inclusion criteria: 1. known or suspected soft tissue sarcoma seen on at least one type of standard imaging (e.g. ct, ultrasound, mri, or 18f-fdg pet/ct) 2. at least 18 years of age 3. subjects with local disease or advanced/metastatic disease will be eligible 4. willing to consent to use of tissue from biopsy or surgery for the purposes of this study 5. participants must be informed of the investigational nature of this study and be willing and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: 1. females who are pregnant at the time of screening will not be eligible for this study; a urine pregnancy test will be performed at screening in women of child-bearing potential 2. inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
impact of early goal-directed fluid therapy in hypovolemic patients undergoing emergency surgery

Conditions: Hypovolemic Shock; Trauma; Emergency; Surgery

Summary: this study compares the safety and efficacy of gdts using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in trauma patients requiring emergency surgery.


Eligibility criteria:
inclusion criteria: * adults \> 18 years * severe hypovolemic condition° * need for emergent interventional procedure under general anesthesia with an expected duration \> 120 min. exclusion criteria: * patients responding to early fluid resuscitation (20ml/kg) who don't require a cvc * neurotrauma (glasgow coma score \< 12) and/ or medullar trauma * known pregnancy or diagnosed by us or ct-scan (\> 14 weeks) * sustained cardiac arrhythmia (see logbook p8) * known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see logbook p8) * known or diagnosed intracardiac shunt: interventricular or atrial defect (see logbook p8) * burn injury \> 10% * needed emergency thoracotomy or abc resuscitation protocol * pre-existing severe liver dysfunction(child-pugh class c) * do-not-resuscitate order, died within 48h of admission * ultra-emergent surgery with no further diagnostic investigation.

Keywords: hypovolemic shock trauma emergency surgery gdt picco