Kornimate/medical-research-clean huggingface dataset:
prevalence, strain circulation and disease burden study of seasonal influenza a and b in panama, selected countries of central america and the caribbean from the year 2010 to 2015

Conditions: Influenza, Human

Summary: the purpose of this study is to assess the prevalence, strain circulation and disease burden of seasonal influenza a and b in panama, selected countries of central america and the caribbean from the year 2010 to 2015.

the gorgas memorial institute for health studies (icges) is a public health institution established in panama dedicated to health research and disease prevention. it has been performing virological isolations of influenza and is a part of the world health organisation (who) global influenza surveillance and response system (gisrs) and a direct collaborator of the centre for disease control and prevention (cdc). from 2010 a sentinel surveillance program is being conducted in panama within the icges to collect data on influenza and other respiratory viruses using cdc guidance for respiratory disease surveillance. this study aims to utilize this data source for analyzing the burden of influenza within the region.

Eligibility criteria:
inclusion criteria: * all subjects diagnosed with seasonal influenza a and/or b, reported in the icges database of panama, from january 2010 to december 2015. exclusion criteria: * n/a.

Keywords: panama influenza b influenza a strain circulation database
long-term integrated telerehabilitation of copd patients. a multi-center trial

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this research project aims to conduct a three-arm multi-center randomized controlled trial (rct) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (copd). the overall purpose of the rct is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with copd, and will improve patient status and quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * at least one copd-related hospitalization or copd-related emergency department presentation in the previous 12 months to enrollment * capable to provide signed written informed consent exclusion criteria: * attendance to a rehabilitation program in the previous 6 months of enrollment * participation in another study that may have an impact on the outcome of this study * deemed by the health care team to be physically uncapable to perform the study procedures * presence of comorbidities wich might prevent the patient from safely undertake an exercise program at home * home environment not suitable for installation and use of rehabilitation and monitoring equipment (e.g. physical space, wi-fi internet or mobile internet via 4g)

Keywords: exercise rehabilitation telemedicine treatment outcome costs and cost analysis physical therapists adaptation, psychological
anti-phospolipid antibodies in lyme borreliosis

Conditions: Patients With Different Manifestations of Lyme Borreliosis; Persons With Nonspecific Symptoms and Positive Borrelia Antibodies in Serum; Blood Donors

Summary: background lyme borreliosis, caused by borrelia burgdorferi sensu lato is transmitted to humans through the bite of an infected ixodes tick. b. burgdorferi sensu lato accumulates intact phospholipids from its environment to support its growth. several of these environmentally acquired phospholipids including phosphatidylserine, phosphatidylcholine and phosphatidic acid may be recognized by anti-phospholipid antibodies that are believed to arose early in infection. here we aimed to investigate the levels of anti-phospholipid antibodies in patients with lyme borreliosis. methods participants included in the study: * 150 patients with well-defined lyme borreliosis, of which 30 presented with solitary erythema migrans (em), 30 with multiple em (mem), 30 with lyme neuroborreliosis (lnb), 30 with lyme arthritis (la), 30 with acrodermatitis chronica atrophicans (aca); * 50 patients with nonspecific symptoms and positive borrelial antibodies in serum; and * 40 healthy blood donors (control group; samples from healthy blood donors were used to determine the threshold for the assays). specimens: * 4 serum samples from each individual patient with well-defined lyme borreliosis (1 before antibiotic treatment, 3 during follow-up up to 1 year); * 2 serum samples from patients with nonspecific symptoms and positive borrelial antibodies (1 before antibiotic treatment and one 3 months later); * healthy blood donors: 1 serum specimen. anti-phospolipid antibodies: levels of igg and igm isotypes of 4 anti-phospholipid antibodies including anti-cardiolipin (acl), anti-phosphatidylserine (aps), anti-phosphatidic acid (apa) and anti-phosphatidylcholine (apc) will be analyzed with in-house elisas.


Eligibility criteria:
inclusion criteria: fulfillment of clinical case definition criteria for european lyme borreliosis (doi: 10.1111/j.1469-0691.2010.03175.x.). exclusion criteria: autoimmune diseases, acute myocardial infarction, acute deep vein thrombosis, pregnancy, syphilis.

Keywords: lyme borreliosis erythema migrans lyme neuroborreliosis lyme arthritis acrodermatitis chronica atrophicans anti-phospholipid antibodies
depot-opioids for pre- and postoperative pain relief after primary knee arthroplasty.tapentadol vs oxycodone vs placebo

Conditions: Joint Diseases

Summary: this study will provide knowledge about the use of long-acting opioids for pain relief after primary knee arthroplasty. the investigators will compare depot tapentadol, depot oxycodone and placebo for effect on pain relief and side effects. the three study groups reflect the three different postoperative pain regimens that have been used the last years at st. olavs hospital, so investigators know that no patient will receive an inadequate pain treatment. the purpose of the study is to find which of the three treatments that gives the best pain relief with the least amount of side effects. the results will be of use for postoperative pain treatment for knee arthroplasty, but also for other types of major surgery. similar studies that are not sponsored by pharmaceutical industry have not been published yet.


Eligibility criteria:
inclusion criteria: * scheduled for knee arthroplasty at st. olavs university hospital * consent in participation in the study exclusion criteria: * contraindications for any of the study drugs * lactose intolerance * known hypersensitivity against any of the additives * chronic obstructive pulmonary disease (copd) grade 3 or 4 * paralytic ileus * known alcohol or medical addiction/abuse * history of asthma, urticaria or allergic reaction caused by acetyl salicylic acid or other nsaids * peptic ulcer * hemophilia * gastrointestinal bleeding * cerebrovascular bleeding * inflammatory bowel disease (ulcerous colitis, crohn disease) * concomitant use of the following drugs: ace-inhibitors, at2-blockers, ssri, anti-psychotic drugs, mao-inhibitors, atazanavir and nelfinavir (medicine used for hiv-infection) * known kidney failure (creatinin level above reference value) * known heart failure (nyha iii-iv) * pregnancy * women in fertile age with risk of pregnancy * nursing women * operated under general anesthesia without use of spinal anesthesia * using opioids on a regular basis except users of codeine or tramadol, or known former abuse of opioids * cognitive failure or other factors which make follow up impossible (for example language difficulties) * no cell phone or internet connection at home (making follow up difficult)

Keywords: arthroplasty, replacement, knee analgesics administration and dosage knee postoperational care pain management
cooperation of insulin and glp-1 on myocardial glucose uptake

Conditions: Type 2 Diabetes

Summary: 27 type 2 diabetic subjects (hba1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. after 3 months' treatment, pet measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).

the investigators will test the hypothesis that effects of liraglutide plus insulin detemir on myocardial fuel selection will be greater than the effects of either agent alone. 27 type 2 diabetic subjects (hba1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). all subjects will undergo an initial standardization of background treatment to metformin 2000 mg per day, followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once daily each morning, tapering up according to label instructions) and/or detemir (administered twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose readings below 130 mg/dl). pet measurements of myocardial fuel selection will take place at the end of this treatment period, under fasting conditions in the morning following that day's treatment injection(s).

Eligibility criteria:
inclusion criteria: * type 2 diabetic * 18-50 years * bmi \> 25kg/m2 * hba1c 7.0-10.0% * treated with up to 2 oral agents exclusion criteria: * chronic illness or infection (other than diabetes mellitus) * known coronary artery disease, structural heart disease or abnormal ecg on screen. * treatment with \>2 antihypertensive agents or blood pressure \>140/95 on two occasions during screening * history of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the pet scanner gantry for the duration of the imaging protocol. * occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period. * current pregnancy * treatment with glp-1 agonist or dpp4 inhibitor within the past 6 months * known intolerance to glp-1 agonist * personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment. * recognized microvascular complications (neuropathy, nephropathy, retinopathy).

Keywords: diabetes myocardial metabolism
hydroxychloroquine as steroid-sparing agent in pulmonary sarcoidosis (hyssas).

Conditions: Pulmonary Sarcoidosis

Summary: the aim of the study is determining the non-inferiority in the overall success rate and the safety for a combination therapy with hydroxychloroquine plus low dose glucocorticoids compared to that for high dose glucocorticoids at 3 and 9 months in patients with pulmonary sarcoidosis.


Eligibility criteria:
inclusion criteria: * patients between 18 and 70 years * parenchymal pulmonary involvement at chest x-ray (cxr) and one of the follows: physiologic abnormalities on pulmonary function testing and/or respiratory symptoms, and/or exercise-induced abnormalities. exclusion criteria: * unable to understand protocol and to sign informed consent or not suitable candidate to comply with the requirements of this study, in the opinion of the investigator * cardiac and neurological sarcoidosis or any other organ involvement * end stage lung disease at high-resolution computed tomography (hrct) * clinical evidence of active infection * documented exposure to beryllium * patients with forced expiratory volume at one second (fev1) changes after salbutamol inhalation ≥20% * comorbidity: advanced liver cirrhosis or abnormal liver function, unstable cardiac disease, moderate to severe renal insufficiency, poorly controlled diabetes * pregnancy or lactation * a tuberculin skin test (5 i.u.) more than 5 mm * psoriasis * homozygous glucose-6-phosphatase deficiency * known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives * visual field changes attributable to 4-aminoquinolines * concomitant therapies: any patient enrolled in the study must be off all prohibited medications at least 4 weeks before screening. once patients completed the washout period, they may enter the screening period that may last up to 30 days * previous therapies: any patient enrolled must be off all medications for sarcoidosis at least 4 weeks before screening.

Keywords: sarcoidosis treatment lung glucocorticoids hydroxychloroquine
seven versus fourteen days of treatment in uncomplicated staphylococcus aureus bacteremia

Conditions: Staphylococcus Aureus Bacteremia

Summary: introduction: staphylococcus aureus bacteremia (sab) plays an important role in long-course antibiotic therapy. current international guidelines recommend fourteen days of intravenous antibiotic treatment for sab in order to minimize risks of secondary deep infections and complications. however, patients with simple sab are known to have a low risk of complications. reducing treatment length in uncomplicated sab would reduce the total consumption of antibiotics, adverse events and duration of hospital admission. sab7 seeks to determine if seven days of antibiotic treatment in patients with uncomplicated sab is non-inferior to fourteen days of treatment. method: the study is designed as a randomized, non-blinded, non-inferiority interventional study. primary measure of outcome will be failure to treatment or recurrence of sab twelve weeks after termination of antibiotic treatment. as a measure of secondary outcome the prevalence of severe adverse effects will be evaluated, in particular secondary infection with clostridium difficile, mortality as well as public health related costs. patients identified with uncomplicated sab, are randomized 1:1 in two parallel arms to seven or fourteen days of antimicrobial treatment, respectively. endpoints will be tested with a statistical non-inferiority margin of 10%. conclusion: sab 7 will determine if seven days of antibiotic treatment in patients with uncomplicated sab is sufficient and safe, potentially modifying current treatment recommendations.


Eligibility criteria:
inclusion criteria: * age \> 18 years * blood culture positive for staphylococcus aureus * antibiotic treatment with antimicrobial activity to s. aureus administrated within 12 hours of the first positive blood culture * temperature \< 37,5 degrees celsius at randomization * s. aureus negative follow-up blood culture obtained 48-96 hours after microbiological verified sab. * patients written consent obtained exclusion criteria: * persistence of s. aureus bacteremia before randomization (s. aureus positive follow-up blood culture obtained 48-96 hours of the first positive blood culture) * polymicrobial infection * antibiotic treatment whit no antimicrobial activity to s. aureus administrated more than 12 hours of the first positive blood culture * endocarditis or other intracardiac infection demonstrated with transthoracic or transesophageal echocardiography * previous history of endocarditis * pacemaker or other intracardiac implant * failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture. * prosthetics in joints and bones or vascular grafts * pneumonia or infection involving bone or joints * previously bone/join infection * s. aureus infection within the last 90 days * pregnancy or breastfeeding * neutropenia (blood neutrophils \< 1,0 x 109/l) * untreated cancer * chemotherapy within 90 days.
vopitb a new devices to determine peripheral arterial stiffness: validation study

Conditions: Cardiovascular Risk Factor; Cardiovascular Diseases; Atherosclerosis of Artery

Summary: our group has developed a device called "velocidad onda de pulso indice tobillo brazo (vopitb)" . in this device the oscillometric method is used for easily and accurately measure the pulse wave velocity pwv in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio, bapwv and cavi). the aim of our study will be to validate the pwv measures by vopitb with other references devices that measures arterial stiffness. moreover we will perform a clinical study to assess the clinical utility of vopitb.


Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years who agree to participate in the study and do not meet any of the exclusion criteria. exclusion criteria: * history of cvd (ischaemic heart disease, stroke or peripheral arterial disease) * atrial fibrillation or other cardiac rhythm disorders * pacemaker-dependent * impalpable arterial pulse at site of measurement * pregnancy * terminal condition * age under 18 years

Keywords: arterial stiffnes pulse wave velocity vopitb validation
calm phase 2b pilot

Conditions: Depression

Summary: managing cancer and living meaningfully (calm) is a brief psychotherapy designed to alleviate distress in advanced cancer. in an earlier intervention-only pilot trial, calm was associated with reductions in depressive symptoms and death anxiety and an increase in spiritual wellbeing. the purpose of this study is to assess the feasibility of a large-scale randomized controlled trial (rct) of calm and to identify preliminary effects in advanced cancer. this phase 2b pilot rct employed intervention and usual care arms with 3 and 6 month follow-ups. the primary outcome was depressive symptoms (phq-9) and secondary outcomes included diagnosis of major depression (scid), death anxiety, attachment security and spiritual wellbeing. multilevel regression was used to compare change over time between groups. 60 patients with advanced cancer will be recruited from the princess margaret cancer centre, toronto, canada, and equally randomized into intervention and usual care conditions.

abstract background managing cancer and living meaningfully (calm) is a brief individual psychotherapy for patients with advanced cancer. in an intervention-only phase 2a trial, calm showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (rct). aims to test trial methodology and assess feasibility of a confirmatory rct. design a parallel-arm rct (intervention vs usual care) with 3 and 6-month follow-ups. assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. primary outcome: depressive symptoms (patient health questionnaire-9; phq-9). secondary outcomes: major depressive disorder (mdd), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. bayesian conjugate analysis was used in this low-powered setting. setting/participants 60 adult patients with advanced cancer from the princess margaret cancer centre. trial registration number nct02353546. http://dx.doi.org/10.1136/bmjspcare-2015-000866

Eligibility criteria:
inclusion criteria: * 18 years of age or older * fluent in english * confirmed diagnosis of stage iiib or iv lung cancer, stage iii or iv ovarian cancer, stage iv endocrine, breast, gastrointestinal, genitourinary or gynecologic cancer, or pancreatic cancer at any stage exclusion criteria: * short orientation-memory-concentration test (score of \<20) * individuals receiving in-hospital psychiatric or psychological treatment at the time of recruitment

Keywords: affective symptoms cancer depression palliative care pilot trial psychotherapy
evaluating clearance of high-risk hpv and safety after administration of abi-2280 vaginal inserts

Conditions: Human Papillomavirus Infection

Summary: this is a blinded study to assess safety, tolerability, and efficacy of abi-2280 vaginal inserts in participants diagnosed with persistent cervical hrhpv infection. this study will have up to 11 cohorts with various dose strengths and regimens. each cohort will start with a sentinel cohort of 8 participants. sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

this is a randomized, double-blind, placebo-controlled phase 1b/2 study in women diagnosed with persistent cervical hrhpv infection. this study is designed to assess safety, tolerability, and efficacy following the use of abi-2280 vaginal insert delivered intravaginally. sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed. dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts, each enrolling up to 8 participants.

Eligibility criteria:
inclusion criteria * female sex, 25 to 55 years of age * positive hrhpv result on at least 2 consecutive tests prior to randomization, one hrhpv+ result at least 12 months prior to screening * cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1. exclusion criteria * history of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia * any clinically significant immune suppressing condition * history or current diagnosis of cervical cancer, suspected or confirmed * plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.

Keywords: hpv sexually-transmitted infection high-risk hpv cin