Kornimate/medical-research-clean huggingface dataset:
taurolidine lock solution in the prevention of catheter related bacteremia

Conditions: Bacteremia; Neoplasms

Summary: children with cancer need a long term tunnelled central venous catheter (tcvc) for the entire duration of their treatment. tcvcs are locked with heparin when not in use. the most frequent complications of long term tcvc are catheter related blood steam infections. taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in tcvcs and has been demonstrated to eradicate infected cvcs. in this study the investigators will compare tcvcs locked with heparin with tcvcs locked with taurolock. hypothesis: taurolock will diminish the number of crbsi in children with cancer compared with children with heparin lock of their cvc.

the most frequent complications of long term tcvc are catheter related blood steam infections(crbsi)often caused by microorganisms located in the biofilm formed on the inner surface of the tcvc after a short time. crbsi may be lifethreatening, will need long term intravenous broad spectrum antibiotic therapy possibly combined with intraluminal antibiotic lock therapy. in spite of this crbsi may often lead to the premature removal of the tcvc. several methods to prevent the occurrence of intraluminal microbial colonization have been investigated with no single method standing out as the optimal one. there is a need for a simple and safe method of reducing the occurrence of crbsi in immunocompromised children receiving chemotherapy for malignant diseases. various catheter lock solutions in stead of using heparin have been investigated in experimental models. taurolidine is a chemically modified amino acid with broad spectrum antimicrobial activity in vitro. it is claimed to prevent the formation of luminal biofilm in tcvcs in a cvc model and it has been demonstrated to eradicate infected cvc in a three reports with a total of 18 patients. in a 24 months study of routine use of taurolidine 1,25%/sodium-citrate 4% (taurolocktm) a reduction of gram-positive cvc associated infections was demonstrated. the findings were not statistically significant due to relatively few patients. there is a need of a larger study with more patients receiving taurolock for locking the tcvc between use in order to test for a significant reduction of the occurrence of crbsi. furthermore there is a need for an in vivo demonstration of the reduction of biofilm formation in tcvcs locked with taurolock compared with tcvcs locked with heparin.

Eligibility criteria:
inclusion criteria: * children aged 0-17 years with malignant disease requiring a tunneled central venous catheter. exclusion criteria: * no written consent from child or parents

Keywords: catheterization, central catheterization, peripheral infection methods sepsis microscopy, electron, scanning sonication taurolidine catheters, indwelling pediatrics
effect of dexmedetomidine for postoperative intravenous patient controlled analgesia

Conditions: Patient-Controlled Analgesia

Summary: the purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous patient-controlled analgesia (pca) after open colorectal surgery.

dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing effects. besides, dexmedetomidine has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. many studies had been conducted to reduce the side effect of opioid analgesic. the current trend of reducing opioid analgesic side effect is direct combination of other drugs in pca. the advantages of this method are convenient in clinical use and preventive for side effects. in this study, 50 patients who is undergoing elective colorectal surgery will be randomly allocated into two groups (control group and dexmedetomidine group). patients in both groups will be given a patient-controlled analgesia (pca) pump in post anesthetic recovery unit (pacu) after surgery. the pca protocol of control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min. the pca protocol of dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists(asa) ⅰ-ⅱ patient undergoing open colorectal surgery 2. written informed consent from the patient or the relatives of the participating patient. 3. bmi:18～30kg/m2 exclusion criteria: 1. mental illness or cannot communicate.; 2. a second operation during the study; 3. slow-type arrhythmias or hypotension; 4. lung infection or sleep apnea syndrome; 5. renal failure; 6. alcohol or drug abuse; 7. already taking gabapentin, pregabalin, benzodiazepin or antidepression drug; 8. long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history;

Keywords: dexmedetomidine dezocine flubiprofen analgesia colorectal surgery
modified adaptive servoventilation (asv) compared to conventional asv

Conditions: Periodic Breathing; Breathing-Related Sleep Disorder

Summary: this study will determine if modified adaptive servoventilation (asv) is as effective as the conventional asv in treating periodic breathing. the study will determine if the modified asv reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional asv.

adaptive servoventilation (asv) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. previous studies in the field have shown that treatment of periodic breathing with asv improves sleep quality and quality of life. in reducing central apneas, asv reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (rem) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. asv can also more effectively reduce central apnea and overall apnea/hypopnea index (ahi) in patients on long-term opiates, and appears to effectively treat complex sleep apnea syndrome. it is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated. this is a prospective, randomised, crossover, observational study. subjects will spend one night on conventional asv and one night on modified asv with full in-lab polysomnography (psg) during therapy on both nights. objective and subjective parameters will be recorded and analysed.

Eligibility criteria:
inclusion criteria: * 21+ years old * chronic resmed asv therapy patient * current asv therapy for at least 4 weeks * able to understand fully the study information and participation requirements * provide signed informed consent exclusion criteria: * acute cardiac decompensation * acute myocardial infarction within last 3 months * resuscitation within last 3 months * stroke with swallowing disorders or persistent hemiparesis * blood pressure test at end expiratory pressure (eep) 10cmh2o not passed * untreated restless legs syndrome * alcohol or drug abuse * known cancer * pregnancy * conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable
the use of expandeded mesenchymal stromal cells (msc) in premature ovarian failure (pof) in adult humans

Conditions: Premature Ovarian Failure

Summary: autologous bone marrow-derived mesenchymal cells will be injected into patients diagnosed with premature ovarian failure

mscs in passage-2 culture will be washed with pbs and detached with trypsin/edta (0.25%). after that, the cells will be suspended at a density of 20×106 cells/ 2 ml normal saline and loaded into 3 ml sterile syringes. the cells should be infused within 2 hours of release. tests and follow up are to be monthly.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent 2. married female, 18-38 years old 3. diagnosis of premature ovarian insufficiency: at least two menopausal fsh levels (≥ 20 iu/l) and/or primary or secondary amenorrhea at least for 6 months 4. evidence of low ovarian reserve defined as: amh \ 20 iu/l, afc \< 4, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder). 5. normal karyotype 46, xx. 6. presence of at least one ovary 7. normal thyroid function as evidence by normal serum thyroid stimulating hormone (tsh) levels. 8. agree to report any pregnancy to the research staff immediately. 9. cooperative patient 10. negative for infectious panel (hiv, hbv, hcv, and vdrl) exclusion criteria: 1. currently breast-feeding 2. has a history of, or evidence of current malignancy 3. major mental health disorder that precludes participation in the study 4. current or recent (within the past 2 weeks) use of the following medications: oral or systemic corticosteroids, hormones (estrogen, progestins, oral contraceptives), danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. washout will be allowed. 5. type i or type ii diabetes mellitus, or if receiving antidiabetic medications 6. significant anemia (hemoglobin \<8 g/dl). 7. untreated deep venous thrombosis, and/or pulmonary embolus 8. known heart disease (new york heart association class ii or higher). 9. known liver disease (defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt)\>2 times normal, or total bilirubin \>2.5 mg/dl). 10. known renal disease (defined as blood urea nitrogen (bun)\>30 mg/dl or serum creatinine \> 1.6 mg/dl). 11. clinically active autoimmune condition
parkinson's disease inflammatory biomarker profiling

Conditions: Parkinson Disease

Summary: this study compares a comprehensive panel of immunological biomarkers between parkinson's disease patients and healthy, environmentally matched participants. this unique study design provides the ability to control for differences in environment between study subjects. the goal of this study is to 1) identify a specific set of immunological markers that correlate with a clinical diagnosis of parkinson's disease and 2) stratify patients by disease severity using these same biomarkers.


Eligibility criteria:
inclusion criteria all participants * subjects must be willing and able to participate in study * subjects must be willing and able to provide written consent to participate. * subjects must be willing and able to comply with scheduled clinic visits and study procedures (updrs exam, blood draw and complete a questionnaire) * subjects are not currently taking an immunomodulatory (e.g. anti- tumor necrosis factor (tnf), immunosuppressants/stimulants) agent in the past 90 days * no active or recent (\< 3 weeks) infection requiring clinical intervention and/or pharmaceutical treatment or febrile neutropenia within the last week. * 18-89 years old parkinson's disease patients * clinical diagnosis of pd by a movement disorders specialist consistent with standard criteria * able to attend a clinical visit in the 'off' state * hoehn and yahr stage i-iv caregiver controls • individuals without pd who share environmental exposures (i.e. spouses, children, caregivers or other individuals who frequently spend significant time (\>6 hours) in proximity to the pd subject) or age and sex matched healthy individuals from general population exclusion criteria all participants * unstable cardiopulmonary or cerebrovascular disease * renal disease or failure w/ serum creatinine greater than 2.5 * severe or unstable depression or other axis i psychopathology * epilepsy * prior brain surgery related to pd (dbs, cell implantation, gene therapy, etc.) * severe head injury with evidence of brain injury * essential thrombocythemia (et) (\>450,000 platelets/ml) * patients currently being treated with any of the following, within the past 5 days: * immunomodulatory agents (e.g. remicade®, humira®, enbrel®) (within the past 90 days) * corticosteroids * probenecid® * coenzyme q10® * anticoagulants

Keywords: immune system immunology neuroinflammation inflammation neuroprotection
efficacy of first mtpj arthrodesis as a treatment in hallux rigidus

Conditions: Hallux Rigidus

Summary: a randomised, controlled trial will be performed by allocating 40 years or older patients with symptomatic hallux rigidus to arthrodesis or watchful waiting group in a ratio of 1:1. our primary outcome will be pain during walking, assessed by the 0-10 numeric rating scale (nrs) at one year after randomisation. our secondary outcomes will be pain in rest (nrs), physical function (moxfq), patient satisfaction in terms of patient-accepted symptom state (pass), health-related quality of life (eq-5d-5l), activity level (the foot and ankle ability measure sports subscale), use of analgesics or orthoses and rate of complications. our null hypothesis is that there will be no difference between arthrodesis and watchful waiting in treatment of hallux rigidus. our primary analysis will be done using intention-to-treat principle.


Eligibility criteria:
inclusion criteria: * age 40 years or over * diagnosis of hallux rigidus: persistent pain on movement of the first mtpj and osteoarthritic first mtpj in plain x-rays * duration of symptoms ≥1 year * pain-nrs during walking of 4 or more on a scale 0-10 (higher is worse) * no substantial pain in other joints of the foot in clinical examination * willingness to accept both treatment options * ability to understand trial information and answer outcome assessments in finnish * signed informed consent exclusion criteria: * asa\* physical status classification level iii or higher * patients with weak co-operation (dementia, schizophrenia, etc.) * patients with neuropathy, i.e. unable to feel 10g monofilament pressure in less than 8 out of 10 standard testing sites * active bacterial infection or ulcer of the lower limb * diabetes mellitus with insulin treatment * diabetes mellitus and ghb-a1c \>64 mmol/mol (regardless of treatment) * history of rheumatoid arthritis, gout or other inflammatory arthritis of the foot * hallux valgus angle \>15° in weight-bearing x-ray * hallux varus in weight-bearing x-ray * large bone cysts in x-ray probably requiring bone grafting in surgery * pain in passive manipulation of ipsilateral first toe ip joint * patients with severe circulatory disorder of the lower limb: absence of palpable pulses in the foot (both dorsalis pedis artery and tibialis posterior artery) * history of surgery of the foot in question * neuropathic pain of the foot in question (i.e., use of neuropathic analgesics) * activity limiting symptoms from an earlier fracture or ligament injury of the foot * patient is not willing to accept the operation within the planned time limits (3 to 12 weeks post-randomisation)

Keywords: surgery foot hallux hallux rigidus arthrodesis
a study to assess all-cause mortality and cardiovascular morbidity in participants with chronic kidney disease (ckd) on dialysis and those not on renal replacement therapy receiving methoxy polyethylene glycol-epoetin beta (mircera) or reference erythropoietin stimulating agents (esas)

Conditions: Chronic Renal Anemia

Summary: this 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in ckd participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference esas. participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving esa treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance esa treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of esa received prior to first methoxy polyethylene glycol-epoetin beta administration. participants randomized to reference esa treatment will receive iv or sc esas in accordance with their prescribed dosing information.


Eligibility criteria:
inclusion criteria: * male or female participants with symptomatic anemia associated with ckd * participants with renal anemia who are not treated with an esa: * anemia was defined as hemoglobin (hb) concentration less than (\<) 11.0 grams per deciliter (g/dl) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for esa treatment * participants with renal anemia who are on maintenance esa therapy: * if on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening * hb concentration between 10 and 12 g/dl (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) * participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent exclusion criteria: * contraindications to esa treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to esa therapy * conditions known to cause inadequate response to esa treatment or anemia other than symptomatic anemia associated with ckd: * history of hemoglobinopathy * anemia due to hemolysis * pure red cell aplasia * high likelihood of early withdrawal (for example, within 1 year) or interruption of the study * pregnancy or breast-feeding * women of childbearing potential without effective contraception * administration of another investigational drug within 1 month before screening or planned during the study period
physical activity, weight and fitness outcomes in children in after-care

Conditions: Obesity; Exercise

Summary: the purpose of this study is to compare the effect of two after-school programs on children's physical activity, fitness, body composition, and academic performance.

tennessee ranks 4th for the highest prevalence of adult obesity in the nation (30.2%), and ranks 5th for the highest rate of youth obesity (36.5%). the division of general pediatrics at vanderbilt has a specific research focus to develop community engagement projects that measurably reduce childhood obesity. metro parks and recreation has been showcased by the national recreation and parks association (nrpa) as a national model for its leadership role in community health and wellness. the two have created a unique academic-community partnership, guided by principals of community-based participatory research (cbpr), that is working to test and disseminate effective metro parks-based programs to reduce pediatric obesity. the proposed study will examine the impact of the coleman community center after-school program on routine physical activity, weight and fitness outcomes in children who belong to the low-income and racial and ethnic minority populations at highest risk for childhood obesity. this study was requested by metro parks and has significant policy implications: if the program is deemed effective in improving daily physical activity, weight and/or fitness outcomes in students, the proposed study will serve as the rationale to expand the program to metro parks' 22 community centers, all of which are located in under-resourced neighborhoods.

Eligibility criteria:
inclusion criteria: * 5 - 15 years * enrolled in public school district * parental permission to access school records exclusion criteria: * under 5 or over 15 * no parental permission to access school records

Keywords: behavioral research community-based participatory research
my choices: efficacy and implementation study

Conditions: Alcohol Use Disorder, Mild; Alcohol Use, Unspecified

Summary: the aim of the study is to assess the efficacy of the my choices - alcohol program by comparing alcohol-use of people before and after doing the program to people that did not do the program on the same period of time (3 months).

people with an alcohol addiction problem consume an average of 26.3 (sd = 12.4) drinks per week (cournoyer et al., 2010). to observe a decrease of 25% in this average number of drinks for the group participating in the program " my choices " immediately compared to the delayed group at 3 months, we need a sample size of 100 participants. this calculation assumes an alpha of 5%, a power of 80% and unbalanced groups due to the randomization method used. considering an attrition rate of 11.3% at 3 months and 20% at 6 months (tremblay et al., submitted), it will be necessary to recruit at least 120 participants to maintain the required number for analyses. references cournoyer, l.-g., simoneau, h., landry, m., tremblay, j., \& patenaude, c. (2010). évaluation d'implantation du programme alcochoix+ (fqrsc #2008-to-120890). f. q. d. r. s. l. s. e. l. culture. tremblay, j., dufour, m., bertrand, k., saint-jacques, m., ferland, f., blanchette-martin, n., savard, a.-c., côté, m., berbiche, d., \& beaulieu, m. (submitted). efficacy of a randomized controlled trial of integrative couple treatment for pathological gambling (ict-pg): 10-month follow-up. journal of consulting and clinical psychology.

Eligibility criteria:
inclusion criteria: * adults with at risk alcohol use (alcohol use over the canadian low-risk alcohol drinking guidelines, without or with low consequences associated with their alcohol use). exclusion criteria: * score at the deba (assessment and screening of assistance needs) indicates a need for specialized treatment. * hospitalization for mental health problems in the last 30 days * people with unstable mental health condition

Keywords: alcohol treatment