Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of novartis meningococcal b vaccine when administered to immunocompromised children and adolescents compared to healthy subjects.

Conditions: Meningococcal Disease

Summary: the study aims at evaluating the safety and immunogenicity of rmenb+omv nz when administered to subjects from 2 to 17 years of age with increased risk of meningococcal disease because either of primary or secondary complement deficiencies or of asplenia or splenic dysfunction. a group of healthy age-matched subjects will be enrolled to serve as a descriptive control for immunogenicity and safety.


Eligibility criteria:
inclusion criteria: inclusion criterion applicable to all groups * subjects aged 2 to 17 years (inclusive) at enrollment * weighing at least 13 kg at the time of enrollment inclusion criterion applicable to group a - subjects at risk of meningococcal disease because of primary or secondary complement deficiencies inclusion criterion applicable to group b - subjects at risk of meningococcal disease because of functional or anatomic asplenia inclusion criterion applicable to group c - healthy subjects exclusion criteria: exclusion criteria applicable to all groups (a, b and c) * history of any previous immunization with a meningococcal b vaccine * history of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine * known hiv infection * history of any progressive or severe neurologic disorder or seizure disorder * contraindication to intramuscular injection or blood drawn * females who are pregnant, planning a pregnancy or nursing (breastfeeding) * females of childbearing potential who have not used or do not plan to use acceptable birth control measures * history or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects exclusion criterion applicable to groups a and b - previous known or suspected disease caused by n. meningitidis in the last year. exclusion criteria applicable to group c * previous known or suspected disease caused by n. meningitidis * known or suspected impairment/alteration of the immune system

Keywords: meningitis vaccination complement deficiency asplenia splenic dysfunction
immunogenicity and safety of a trivalent inactivated influenza vaccine, formulation 2010-2011, in non-elderly adult and elderly subjects

Conditions: Influenza

Summary: each potential subject will be screened before the start of the study to determine their eligibility for participation. just prior to vaccination, a 10 ml venous blood sample will be taken from each eligible subject, for baseline titration of circulating anti-ha antibodies. immediately thereafter, each subject received one dose of vaccine (0.5 ml) by intramuscular injection into the upper arm. subjects will be asked to stay at the site for 30 minutes post-vaccination to observe for immediate reaction. subjects will be monitored for adverse events during the study. at three weeks (±3 days) after the vaccination, subjects will be asked to return to the site for final collection of blood samples.


Eligibility criteria:
inclusion criteria: * males and non-pregnant females and aged ³ 18 years; * willing and able to adhere to visit schedules and all study requirements; * subjects read and signed the study-specific informed consent. exclusion criteria: * subject or his/her family is employed by the participated hospital; * subjects received influenza vaccine (trivalent and/or a(h1n1)) within the previous 6 months; * history of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication; * personal or family history of guillain-barré syndrome; * an acute febrile illness within 1 week prior to vaccination; * current upper respiratory illness (uri), including the common cold or nasal congestion within 72 hours; * patients with influenza-like illness as defined by the presence of fever (temperature ≥38ºc) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough; * female subjects who are pregnant, lactating or likely to become pregnant during the study; women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, iud, barrier device or abstinence) throughout the study. * treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent; * immunodeficiency, immunosuppressive or household contact with immunosuppression; * history of wheezing or bronchodilator use within 3 months prior to study vaccine; * receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt within 1 month of study vaccination; * receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt within 1 month of study vaccination; * receipt of any blood products, including immunoglobulin in the prior 3 months; * underlying condition in the investigators' opinion may interfere with evaluation of the vaccine; * significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Keywords: influenza vaccine immunogenicity
cholesterol metabolism in plasma and interstitial fluid among subjects undergoing hemodialysis.

Conditions: Diabetes Mellitus, Type 2; Diabetic Nephropathies; Chronic Kidney Diseases

Summary: because the atherosclerosis process partly occur in the intercellular space of the vessel wall, the determination of the constitution of lipoproteins in the interstitial fluid may expand the knowledge about the atherosclerosis process and lead to a better understanding of what constitutes the increased risk of developing cardiovascular disease in patients with chronic diseases. the investigators hypothesize that the apob-containing particles in t2d patients are more susceptible to be retained or consumed in the intercellular compartment, which in turn could be one explanation for the elevated risk of atherosclerosis. the investigators hypothesise that with the progression of chronic kidney disease this process is further increased. patients undergoing dialysis are known to have a very high risk of cardiovascular disease. the investigators now want to study the cholesterol metabolism in interstitial fluid in subjects undergoing hemodialysis because of diabetic nephropathy and in subjects undergoing hemodialysis because of chronic kidney disease of other causes.


Eligibility criteria:
inclusion criteria: diabetic nephropathy, because of type 2 diabetes, undergoing hemodialysis and subjects with chronic kidney disease of other causes undergoing hemodialysis. exclusion criteria: * active infection that increases the risk of secondary infection in the skin where the vesicles containing interstitial fluid have been emptied of interstitial fluid with a fine needle and the bladder roof is intact. * treatment with warfarin due to increased risk of calciphylaxis (calcific uremic arteriolopathy, cua)
use of alternative therapy in psoriasis vulgaris patients

Conditions: Psoriasis Vulgaris

Summary: psoriasis vulgaris is a chronic, recurrent, inflammatory and hyperproliferative skin disease. joint involvement is common along with skin involvement. however, metabolic diseases, such as cardiovascular diseases can be accompanied by many systemic diseases, chronic and repetitive due to the quality of life and psychological status of patients can affect. today, although the treatment is repetitive, chronic and requires follow-up due to the disease patients can turn to alternative and complementary medicine techniques. in recent years, studies on alternative medicine and complementary therapies have been noted in the medical literature. these studies also include case reports related to psoriasis vulgaris. however, in our country, there is no study that tells us whether patients with psoriasis vulgaris apply these treatments or not and what the practitioners think about the success of the treatment. the aim of the study will be to clarify issues such as whether patients with psoriasis vulgaris apply alternative medicine and complementary therapies for their disease.


Eligibility criteria:
inclusion criteria: * psoriasis vulgaris patients exclusion criteria: * the patients that don't want to answer the questions
tissue analysis after tumor ablation for liver metastases leading to immediate retreatment

Conditions: Liver Metastases

Summary: this study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. the results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.


Eligibility criteria:
inclusion criteria: * diagnosis of liver metastases from various primary tumors * confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed) * lesions of ≤3 cm in maximum diameter * at least one fdg-avid lesion to be treated\*\*\* * inr \< 1.5\* * platelet count ≥ 50,000 exclusion criteria: * age \< 18 * less than 5 mm distance to a structure (gi or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection * inr \> 1.5 that cannot be corrected with fresh frozen plasma \*\* * platelet count of \<50,000 that cannot be corrected with transfusion * more than 3 tumors in the liver * more than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis) * presence of any peritoneal carcinomatosis * for patients on coumadin, general clinical guidelines for ir ablation will be followed. * for patients with no fdg-pet avid tumors aim 2 of the protocol will not be assessed

Keywords: optimizing tumor ablation rapid tissue analysis metabolic imaging biomarker validation predictive genetic signatures 19-332
autotitrating versus standard non-invasive ventilation (niv) in acute exacerbation of respiratory failure

Conditions: Respiratory Failure; Neuromuscular Disease; Chest Wall Disorder; Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome

Summary: the aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (niv) versus standard niv in patients admitted to hospital with acute exacerbation of chronic respiratory failure. the investigators hypothesise that autotitrating niv will ventilate patients with acute exacerbations of chronic respiratory failure as effectively as standard niv.

the aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients admitted to hospital with a sudden worsening of their existing breathing insufficiency, including an increase of carbon dioxide in the blood (hypercapnia) and acidity of the blood. noninvasive ventilation (niv) is standard therapy for patients with acute hypercapnic exacerbations (sudden worsening of existing breathing insufficiency) of both chronic obstructive pulmonary disease (copd) and noncopd patients. the most common type of niv is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. standard bilevel niv (vpap™) has been further developed to create a new automatically adjusting niv (autovpap™). automatically adjusting niv varies the inspiratory air pressure according to the airflow rates generated by the patient. this may improve patient comfort, hours of niv use and recovery time. patients over the age of 18 admitted to royal brompton hospital respiratory ward will be considered for entry into this randomised crossover study. if eligible for inclusion and willing to take part patients will be setup on automatically adjusting niv or standard niv, assigned in random order. after 24 hours on the first niv the patient will be swapped to the alternative niv for a further 24 hours of treatment.

Eligibility criteria:
inclusion criteria: * patients admitted or transferred to royal brompton hospital with acute exacerbation of chronic respiratory failure, or inpatients who suffer a deterioration in respiratory status, defined as 7.25 \ 6.0kpa, and respiratory rate \> 20bpm exclusion criteria: * \< 18 years old * ph \< 7.25 * need for immediate intubation * uncontrolled cardiac failure * hypotensive (systolic blood pressure \< 90mmhg) * acute myocardial infarction * acute dysrhythmia * other system failure (e.g. acute renal failure, liver failure) * moderate or severe bulbar weakness * inability to understand rationale and/or consent form for study

Keywords: acute exacerbation respiratory insufficiency respiratory failure hypercapnia hypoventilation sleep hypoxia titration non invasive ventilation
evaluation of free aminoacids in saliva as a diagnostic biomarker of periodontal disease

Conditions: Periodontitis; Diagnoses Disease

Summary: amino acids (aas) are organic molecules that are associated with inflammation and innate immunity diseases with critical roles in the cell repair and protection process. our aim was to identify the free amino acids in saliva of a group of periodontitis patients and healthy individuals and additionally to assess their levels in different periodontal disease types and compare it to the healthy individuals.

the study consisted of three groups: healthy individuals (control(c); n=20), stage iii grade b generalized periodontitis (gp-b; n=20), and stage iii grade c generalized periodontitis (gp-c; n=20). clinical periodontal parameters (plaque index (pi), gingival index (gi), probing depth (ppd), gingival recession (gr), clinical attachment level (cal) and bleeding on probing (bop)) were measured. the amino acid analysis in saliva was accomplished by liquid chromatography-mass spectrometry (lc ms/ms) as mean concentration.

Eligibility criteria:
inclusion criteria: systemically healthy, clinical diagnosis of periodontitis, clinical diagnosis of periodontal health exclusion criteria: history of regular use of systemic antibiotics, anti-inflammatory, or antioxidant drugs (previous 3 months); nonsurgical periodontal treatment (previous 6 months); surgical periodontal treatment (previous 12 months); presence of \<10 teeth; current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy); diabetes diagnosis; rheumatoid arthritis diagnosis; and pregnancy, lactating, smoking, or excessive alcohol consumption.

Keywords: saliva amino acids periodontitis
cell distribution in induced sputum in patients with asthma

Conditions: Bronchial Asthma With eNO-levels Greater Than 30 ppB

Summary: the aim of this case-control study is the comparison of the cell distribution in induced sputum in young adults with asthma and in healthy controls. the study consists of two visits. at both visits subjects are asked to perform a lung function test (body plethysmography) and levels of exhaled nitric oxide (eno) are measured. at the first visit a blood sample is drawn to determine the inflammatory and allergic status of the subjects and the sputum is induced by an ultrasonic nebulizer. at the second visit another sputum sample is induced by a nozzle nebulizer. the cell distribution will be evaluated in both sputum samples.

objectives: the aim of this study is the characterization of healthy children/ young adults and matched patients with asthma in terms of lung function, and the degree of the systemic and bronchial inflammation. sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qrt-pcr) and by a cytometric bead assay (cba). components of the innate immune system (mannose-binding protein, tlr recognition proteins and surfactant proteins) are determined from sputum or blood respectively. methods and work programme: this study consists of two study visits (v1 and v2) v1 (day 0 - duration 1 hour): * measurement of exhaled nitric oxide (eno) * lung function testing with and body plethysmography * blood test: blood count, crp, rast, serum inflammatory mediators, markers of the non-specific pulmonary defense system * induced sputum attained by an ultrasonic-nebulizer for inflammatory mediators and microbiological investigations v2 (day 14-28 - duration 1 hour): * measurement of nitric oxide in expired air (eno) * lung function testing with spirometry and body plethysmography * induced sputum attained by a nozzle-nebulizer for inflammatory mediators and microbiological investigations study population: children, adolescents and young people (6 - 25 years of age). both the patients and the healthy subjects are recruited from the outpatient clinic of pediatric allergy and pulmonology.

Eligibility criteria:
inclusion criteria: * informed consent * between 6 and 25 years of age * known bronchial asthma/no bronchial asthma(depending on the study group) * ability to perform lung function tests and inhalation exclusion criteria: * \ 25 years of age * any acute condition with systemic or bronchial inflammation * any chronic condition or infection (e.g. hiv, tuberculosis, malignancy) * pregnancy * known alcohol and/ or drug abuse * inability to understand the extent and scope of the study * participation in another study

Keywords: asthma sputum blood inflammation adaptive immune system innate immune system
a study of ono-1110 in patients with postherpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: to evaluate the efficacy and safety of ono-1110 in japanese patients with postherpetic neuralgia


Eligibility criteria:
inclusion criteria: * japanese (both sexes) * age (at the time of informed consent): 18 years and older * outpatient * patients with persistent pain ≥3 months (90 days) after the onset of herpes zoster * patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator) exclusion criteria: * patients who previously underwent neurodestruction or neurosurgical therapy for phn * patients with pain other than phn that may affect assessments in this study * patients with any skin condition related to the site of herpes zoster that may affect assessments in this study * patients with a past history of or concurrent neurologic diseases that may affect assessments in this study * patients with concurrent psychiatric diseases that may affect assessments in this study

Keywords: ono-1110 ono-1110-04 postherpetic neuralgia phn
cosmesis, patient satisfaction and quality of life after da vinci single site and multiport laparoscopic cholecystectomy

Conditions: Symptomatic Gallbladder Disease

Summary: prospective, randomized , multicenter study comparing cholecystectomy performed with da vinci single site instruments™ to multi-port (four ports) laparoscopy

prospective, randomized , multicenter study comparing cholecystectomy performed with da vinci single site instruments™ to multi-port (four ports) laparoscopy. * the primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da vinci single- site instruments™ in comparison to a multiport laparoscopic approach. * the secondary objective of this study is to assess the peri-operative clinical outcomes of robotic- assisted single incision cholecystectomy with da vinci single - site instruments™ in comparison to a multiport laparoscopic approach. * the third objective of this study is to evaluate hernia incidence at 1 year and 18 months after surgery

Eligibility criteria:
inclusion criteria: * patient between ages of 18- 80 year * patient with symptomatic gallbladder disease * patient willing to participate in this study and able to provide informed consent exclusion criteria: * patient pregnancy * emergency patient * patient with acute cholecystitis * patient with upper midline visible abdominal scars or keloid * presence of umbilical hernia , or prior umbilical hernia repair * inability of patients to tolerate trendelenberg position or pneumoperitoneum * patient with cirrhosis * patients with mental impairment that preclude giving informed consent

Keywords: robotic single-site cholecystectomy laparoscopic cholecystectomy cosmesis quality of life
clinical and radiographic evaluation of mta pulpotomy versus conventional pulpectomy in primary molars with irreversible pulpitis

Conditions: Decayed Primary Molars With Irreversible Pulpitis

Summary: this study is designed to compare between mta pulpotomy (removal of coronal pulp tissue, placing mta and covering with stainless steel crown) versus conventional pulpectomy (removal of radicular pulp tissue, placing zinc oxide/eugenol and covering with stainless steel crown) in irreversible pulpitis in primary second molars.


Eligibility criteria:
inclusion criteria: * patients: * aged 4-7 years, cooperative, in good general health and medically within normal * teeth: * restorable mandibular second primary molars. * history of irreversible pulpitis. * preoperative radiograph: * absence of periapical or inter-radicular radiolucency. * absence of widening of periodontal ligaments (pdl) space. * absence of internal or external root resorption. exclusion criteria: * patients: * with systemic disorders. * physical or mental disabilities. * unable to attend follow- up visits. * refusal of participation. * refusal to sign the informed consent. * teeth: * previously accessed teeth. * mobile mandibular second primary molar. * swelling in the vestibule or on palpation. * pain on percussion.

Keywords: mta pulpotomy pulpectomy decayed primary molars irreversible pulpitits
mbct and cbt for depression in patients after cancer: a randomized controlled trial

Conditions: Depressive Symptoms

Summary: the purpose of this study is to determine whether mindfulness-based cognitive therapy (mbct) and cognitive behavioral therapy (cbt) are effective in reducing depressive symptoms in patients after cancer

cancer patients are prone to develop depressive symptoms, even after curative treatment. conventional therapies such as cognitive behavioral therapy (cbt) and mindfulness-based cognitive therapy (mbct) are frequently used for reducing these depressive symptoms in patients with medical conditions. however, until now evidence from proper designed randomized controlled trials regarding the effectiveness of both interventions in cancer survivors, is lacking. therefore, our longitudinal study aims to investigate the effectiveness of cbt and mbct in reducing depressive symptoms in cancer survivors. in addition, potential moderators and mediators of each intervention will be explored.

Eligibility criteria:
inclusion criteria: * written informed consent * completion of curative cancer treatment (for primary diagnosis of cancer or possible recurrence of cancer) at least one year ago and no longer than five years ago. * currently no active cancer. * ≥ 18 at the time of diagnosis of cancer and ≤ 75 at inclusion. * depressive symptoms as assessed by a patient health questionnaire (phq-9) score ≥ 10 (indicating presence of at least mild depressive symptoms). * being able to read, write, and speak dutch. exclusion criteria: * severe psychiatric co-morbidity (i.e. acute suicidal ideations or behavior, recently experienced psychosis, diagnosis of schizophrenia, bipolar disorder, drug abuse or substance dependence, serious cognitive or neurological problems). * receiving psychological treatment for depressive symptoms, currently or less than two months prior to study participation. * unstable antidepressant medication regimen two months prior to inclusion of the study

Keywords: cancer depression mbct cbt