Kornimate/medical-research-clean huggingface dataset:
immune response in ixiaro batch jev09l37 recipients before and after revaccination

Conditions: Japanese Encephalitis

Summary: ic51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of ixiaro jev09l37 during primary immunization.

ic51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of ixiaro jev09l37 during primary immunization. a total of up to 50 subjects having received primary immunization of ixiaro batch jev09l37 and who have not yet been revaccinated.

Eligibility criteria:
inclusion criteria: * subjects 18 years or older having received ixiaro batch jev09l37 during primary immunization * in female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception * written informed consent obtained from the subject prior to any study-related procedures exclusion criteria: * vaccination against yellow fever, dengue fever, west nile fever or tbe or vaccination with any je vaccine since primary immunization with ixiaro jec09l37 * clinical manifestation of any flavivirus infection since primary immunization with ixiaro jec09l37 * acute febrile infections or exacerbation of chronic infection on the day of ixiaro vaccination * pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects. * use of any other investigational or non-registered drug within 30 days prior to the first vaccination with ixiaro visit 1 and during the study period * any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator * persons who are committed to an institution * at day 0, upcoming scheduled travel to a je endemic region

Keywords: japanese encephalitis ixiaro japanese encephalitis vaccine
treatment of severe peanut allergy with xolair (omalizumab) and oral immunotherapy

Conditions: Peanut Allergy

Summary: severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. there is no cure today. the purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-ige (immunoglobulin e) antibodies (omalizumab), and thereby inducing tolerance to peanuts. the treatment will be monitored by basophil cell stimulation (cd-sens).

oral immunotherapy (oit), where the food protein is consumed in increasing amounts, have been studied with good results, but allergic reactions has been a major problem. anti-ige antibodies (omalizumab) block allergy antibodies so that the allergic reaction is absent. a new test in which basophil cells stimulated with allergen in vitro, cd-sens, showing cell sensitivity, correlates well to peanut challenges. twenty children/adolescents, 12 to 22 years, with severe peanut allergy will be treated with omalizumab and the effect evaluated with cd-sens. if the cd-sens is negative a peanut challenge will be performed. if the challenge is negative the oit will start: 1, 2, 4, 8 g peanuts/day in two-week intervals followed by a maintenance dose of 10 g peanuts/day while continuing treatment with omalizumab. if the cd-sens is still negative the withdrawal of omalizumab will start by halving the dose in several steps. the study is independent of pharmaceutical companies. omalizumab is dosed according to body mass and the amount of total ige antibodies and therefore every individual has an individual study duration. in average the duration of the study is estimated to 52 weeks +/-40/20 weeks. inclusion in the study is expected to last for the 2 coming years. a treatment without serious side effects for those with severe food allergies would give a great benefit with reduced anxiety and fear, but also major health economic benefits in the form of fewer hospitalizations, sick leave, and to a greater extent completed school and education.

Eligibility criteria:
inclusion criteria: * ige to peanut, ara h 1, ara h 2 and ara h 3 * ige to an airborne allergen i.e. cat, dog, horse, birch, grass etc. * clinical allergic reactions to peanut the last 5 years * positive conjunctival challenge to the selected airborne allergen * positive cd-sens to peanut and the selected airborne allergen * ige according to the recommendations of the manufacturer * written consent exclusion criteria: * no severe diseases like renal failure, hart disease, immunodeficiency, diabetes or other severe chronic diseases * pregnancy * no previous hypersensitivity reactions to sucrose, histidine, polysorbat 20 or omalizumab
shave margins vs. standard partial mastectomy in breast cancer patients

Conditions: Breast Cancer

Summary: breast cancer is the most common malignancy affecting women in the us. surgical management is the mainstay of therapy, and in general consists of resection of the primary tumor with either a partial mastectomy (aka "lumpectomy") or a total mastectomy. the investigators hypothesize that routine shave margins during partial mastectomy will significantly reduce positive margin rate. a positive margin means that cancerous cells were detected at the edge of the excised area. this generally mandates a return to the operating room for re-excision.

some authors have investigated, in a retrospective fashion, the use of routine shave margins, where surgeons routinely take additional margins at the time of the initial partial mastectomy as a means of obtaining negative margins. while these retrospective studies have found that positive margin rates declined using this technique, opponents to this technique wonder if this truly results in a higher negative margin rate without compromising cosmesis or increasing tissue volume removed. as these studies were retrospective, it was possible that the initial resection was smaller than what those who do not routinely take shave margins would resect. no one had evaluated the impact of further resection on operative time, nor in a blinded fashion, evaluated cosmesis. further, there had yet to be a prospective study to evaluate the impact of this on local recurrence rates. hence, the investigators performed a prospective randomized controlled trial of this technique at yale. the data from this study, published in the new england journal of medicine, found that the technique cut positive margin and re-excision rates in half. some wondered, however, about the external generalizability of these findings, particularly in non-academic settings. hence, a multicenter trial to validate these findings is warranted.

Eligibility criteria:
inclusion criteria 1. breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same 2. women ≥ 18 years of age 3. ability to understand and the willingness to sign a written informed consent document. exlusion criteria 1. total mastectomy 2. known metastatic disease 3. bilateral synchronous breast cancer 4. multicentric cancers requiring double lumpectomy 5. previous history of breast cancer (even in the other breast) 6. patients receiving intraoperative radiation therapy (iort) 7. patients who had excisional biopsy for diagnosis of their cancer (i.e., instead of a core biopsy)

Keywords: mastectomy
longitudinal evaluation of a fracture liaison service

Conditions: Osteoporosis

Summary: the major objective of this study is to evaluated osteoporosis prevalence, both on computed tomography (ct) and dual x ray absorptiometry (dxa) in patients included in a fracture liaison service (fls). the secondary objectives are to evaluate the prevalence of antiosteoporotic treatments indication, of new fractures or mortality; to identify the risk factor for osteoporosis; the study the treatment's observance; to identify the screening threshold to diagnose osteoporosis on ct.


Eligibility criteria:
inclusion criteria: * age \>= 50 years * bone fracture due to a fall exclusion criteria: * patient's opposition

Keywords: osteoporosis fractures dxa ct
kinetic method to detect dehydration

Conditions: Dehydration

Summary: 1. the distribution and elimination of infusion fluids can be studied by volume kinetics, a mathematical method based on serial analysis of the blood hemoglobin concentration. 2. the hypothesis of the present study is that the elimination of infused fluid is retarded in the presence of dehydration, and that volume kinetics would therefore be capable of detecting dehydration in human subjects. 3. we induce dehydration by injection graded doses of furosemide (a diuretic drug) in healthy volunteers and the kinetics of an infusion of crystalloid fluid is compared to when the same volunteer receives the same fluid without being in a dehydrated state.

1. fifteen healthy male volunteers are subjected to 4 experiments. they drink 800 ml of water at 6:00 am to make sure they are not dehydrated when the experiments begin. 2. on two occasions the volunteer receives, at 9:00 am, an intravenous infusion of acetated ringer´s solution being either 5 ml/kg or 10 ml/kg, over 15 min. the blood hemoglobin concentration is measured during 16 occasions during 120 min by invasive blood sampling and also non-invasively by a pulse oximeter (masimo´s radical 7). 3. on two other occasions, the infusions are preceded for 2 hours of deliberate dehydration. doses of furosemide 5 mg are repeated 3-4 times with the goal of creating dehydration amounting to approximately 2 liters of fluid. excreted urine is collected and the volume measured. 4. the kinetics of each infusion is calculated by volume kinetics, and the data compared pairwise from the experiments with and those without dehydration. 5. the accuracy and precision of the non-invasive monitoring of hgb can be determined. 6. the study is ended with that the hgb response between the lying and sitting position is compared and with that the fluid balance is restored by ingestion of water. 7. experiments are performed in the department of intensive care at linköping university hospital, sweden.

Eligibility criteria:
inclusion criteria: * healthy male. exclusion criteria: * disease for which daily medication is required. * poor peripheral perfusion; defined as a perfusion index, as measured by masimo´s radical 7, of 2 or less.

Keywords: dehydration fluid therapy pharmacokinetics hemoglobin
efficacy and safety of qmf149 vs. salmeterol xinafoate/fluticasone propionate in patients with chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: to compare the efficacy, safety and pharmacokinetics of qmf149 delivered via concept1 to salmeterol xinafoate/fluticasone propionate delivered via accuhaler in adult patients with copd


Eligibility criteria:
inclusion criteria: * patients with moderate to very severe copd (gold 2 to gold 4) according to the 2011 global initiative for chronic obstructive lung disease (gold) guidelines * patients with a post-bronchodilator fev1 \< 70% of the predicted normal, and a post-bronchodilator fev1/fvc \< 0.70 at run-in (visit 101). * current or ex-smokers who have a smoking history of at least 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked. e.g.10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). an ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening. exclusion criteria: * patients who have had a copd exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to screening (visit 1). * patients who develop a copd exacerbation between screening (visit 1) and treatment (visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the copd exacerbation. * patients who have had a respiratory tract infection within 4 weeks prior to screening visit 1. * patients who develop a respiratory tract infection between screening (visit 1) and treatment (visit 201) will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection. * patients requiring long term oxygen therapy prescribed for \>12 hours per day. * patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: copd
cerebral microembolization associated with pfo closure

Conditions: Thrombosis Cardiac; Atrial Septal Defect; Patent Foramen Ovale (PFO)

Summary: this study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of pfo or asd, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within pfo.

patent foramen ovale (pfo) is prevalent in the general population and it is commonly accepted that pfo is associated with various pathological conditions, including ischemic stroke, transient ischemic attack, migraines, and systemic or coronary embolization. in situ thrombus formation may play a role in patients with pfo-associated stroke or migraines. after transcatheter closure of pfo, peri-interventional cerebral embolic lesions have been detected. this study aims to investigate (1) the de novo cerebral microembolization in patients who undergo transcatheter closure of pfo or asd, and (2) evaluate the relationship between de novo cerebral microembolization and in situ thrombus within pfo.

Eligibility criteria:
pfo group inclusion criteria: 1) age 18 to 65 years; 2) documented pfo with medium-to-large shunts (≥ 20 microbubbles by c-tcd at rest or during the valsalva maneuver); 3) history of embolic stroke (based on brain magnetic resonance imaging within 24 hours after symptom onset) or tia within 6 months without other identifiable causes; 4) history of migraine for more than one year without other identifiable causes; 5) asymptomatic group: incidental finding of pfo in asymptomatic individuals, and presence of high-risk activities and/or anatomical features related to pfo (high-risk activities were defined as those in which the valsalva maneuver was performed frequently or those that increased the risk of venous gas formation; and high-risk anatomical features included atrial septal aneurysm and/or curtain pattern on c-tcd). exclusion criteria: 1) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) history of embolic stroke or tia within the past one month; 3) history of deep vein thrombosis or pulmonary embolism; 4) presence of coronary artery disease and carotid artery lesions; 5) presence of coexistent cardiovascular structural malformations or diseases; 6) allergy to contrast medium; 7) refusal to participate. asd group inclusion criteria: 1) age 18 to 65 years; 2) secundum asd size 10 to 20 mm, with sufficient surrounding rims, except the aortic rim; 3) right heart catheterization: resting spap \< 50 mm hg, qp/qs ≥ 1.5 and pvr \< 5 wu. exclusion criteria: 1) presence of any known vascular risk factor, including hypertension, hypercholesterolemia, diabetes mellitus, atrial fibrillation, smoking and obesity; 2) associated with other cardiac abnormalities or diseases; 3) resting spap ≥50 mm hg and resting pvr ≥5 wood units;4) primum or sinus venosus type asd; 5) presence of intracardiac thrombi, permanent contraindications to platelet therapy, and allergic reaction to nickel.

Keywords: patent foramen ovale; stroke; migraine; thrombus
daily ultrasound-screening for cvc-related thrombosis

Conditions: Central Venous Catheter Thrombosis; Critical Illness; Ultrasonography

Summary: the central venous catheters (cvc) related thrombosis is an issue of importance to icu clinicians.this study conducts the daily ultrasound-screening for cvc-related thrombosis (duct).its aim is to evaluate the characteristic and regularity of the central venous catheters (cvc) related thrombosis in icu patients, and optimize the screening program of cvc-related thrombosis.


Eligibility criteria:
inclusion criteria: * consecutive patients at least 18 years of age, expected to need a central venous catheterization for at least 48h in icu. exclusion criteria: * patients with infection or inflammation or local trauma at the insertion site.

Keywords: central venous catheters venous thrombosis ultrasound critical care
pediatric acute respiratory distress syndrome ventilation bundle

Conditions: Acute Respiratory Distress Syndrome

Summary: mortality rates in children with pediatric acute respiratory distress syndrome (pards) are higher in asia compared to other regions. in adults with acute respiratory distress syndrome, the only therapy that improves mortality rates is a lung protective ventilation strategy. the pediatric ventilation recommendations by the pediatric acute lung injury consensus conference (palicc) are extrapolated from evidence in adults, including ventilation with low tidal volume, low peak/plateau pressures and high end expiratory pressure. a recent retrospective study of ventilation practices in asia including singapore showed that a majority of patients with pards were being ventilated with high tidal volume, high peak pressure and low end expiratory pressure, not in compliance with palicc recommendations. we postulate that currently used ventilation strategies could have contributed to the high pards mortality rates in asia. we aim to determine if implementing a ventilation bundle comprising palicc recommendations lowers pards and pediatric intensive care unit (picu) mortality rates.

we implement a pards ventilation bundle compliant with palicc recommendations. the bundle contains a daily checklist for ventilation targets and reference tables listing targeted tidal volumes and end expiratory pressure-fraction of inspired oxygen titration. we will recruit mechanically ventilated patients who meet pards criteria. after a one-month implementation period, we will collect patient data over the subsequent 18 months, and compare them with the corresponding data in the 24 months prior to the implementation. the primary outcome is pards mortality, defined as number of deaths out of pards cases. secondary outcomes are feasibility of ventilation bundle implementation, ventilator (vfd) and intensive care unit (ifd) free days and picu mortality (number of deaths out of picu admissions).

Eligibility criteria:
inclusion criteria: * fulfill criteria for pards * mechanically ventilated exclusion criteria: * perinatal lung disease
paracetamol in addition to who step iii opioids in chronic cancer pain control

Conditions: Pain

Summary: blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.

chronic pain patients receiving a strong opioid in combination with paracetamol in a minimum dose of 1.5 g/day will be randomized to receive either paracetamol in the dose already prescribed (group "paracetamol") or an identically looking placebo (group "placebo") using the same schedule during the first study phase (days 1-7). in the second study phase (days 8-14) paracetamol or placebo will be stopped in both arms to assess the effect of pill withdrawal on pain control. next to baseline the patients will be instructed to use a pain diary to rate their pain during the study and also document the required opioid rescue doses. further assessments will include adverse events, subjective ratings of quality of sleep, overall feeling of functioning and quality of life. at the screening visit, patients will also be asked to rate their expected changes in pain relief as a result of co-treatment with paracetamol. at the completion of the study, patients will be asked about their preference and whether, overall, they felt their pain was more poorly controlled during the study. adherence will be checked by pill count and measurement of paracetamol blood concentrations. genotyping of oprm1, comt and relevant cyp enzymes and opioid blood concentrations will be assessed as co-variates for pain control.

Eligibility criteria:
inclusion criteria: * male and female patients receiving a who step iii opioid (i.e. morphine, oxycodone, methadone, fentanyl, hydromorphone, or buprenorphine) in combination with paracetamol (minimum dose 1.5 g/day) * age ≥ 18 at screening * ability to understand the study procedures and to provide written informed consent * stable analgesia before randomisation, defined as no required changes in the analgesic treatment during the previous 7 days exclusion criteria: * participation in another interventional trial within 30 days prior to randomisation, with the exception of cancer treatment trials * changes of the dosage or start of other (co-)analgesics (e.g. tricyclic antidepressants, neuroleptics, nonsteroidal anti-inflammatory drugs (nsaids), dipyrone), within the last 7 days preceding randomisation * surgery within the 14 days preceding randomisation or surgery planned within the duration of the study * any circumstances, comorbidities or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the study protocol
fragility fractures of the pelvis (ffp)

Conditions: Pelvic Fracture

Summary: prospective data will be collected in approximately 420 patients, above the age of 65, suffering from an ffp type fracture equal to or higher than type ii, according to rommens and hofmann. patients will be followed up according to the standard (routine) for up to 1 year after the treatment. data collection will include underlying disease, treatment details, functional and patient reported outcomes (pro)s, radiological outcomes, and anticipated or procedure-related adverse events (i.e. complications).

more in detail this registry has the following objectives: * to identify the difference in patient related outcome comparing the surgical and conservative treatment in patients suffering from an ffp with different levels of pelvic instability at different time points * to compare the rate of complications, morbidity and mortality between the different treatment modalities over the whole study period

Eligibility criteria:
inclusion criteria: * age 65 years or older at time of injury * diagnosis, via ct scan as per standard of care, of ffp grade ii or higher according to the rommens and hofmann classification (including fractures of the anterior pelvic ring involving the anterior lip of the acetabulum not regarded as the acetabular fractures) * informed consent obtained, ie: * ability to understand the content of the patient information/icf * willingness and ability to participate in the registry according to the standard of care in each clinic * signed and dated ethics committee (ec)/ institutional review board (irb) approved written informed consent or * written consent provided according to the irb/ec defined and approved procedures for patients who are not able to provide independent written informed consent exclusion criteria: * pelvic fractures that do not meet the criteria of a fragility fracture (ie, high-energy trauma) * ffp type i fractures * concomitant fractures of the acetabulum (except anterior lip of the acetabulum, see above) * pathological fractures (ie, patients with malignant or metastatic diseases of the pelvis, infections) * concomitant osteoporotic fractures outside of pelvis * participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the pi the results of the present registry

Keywords: pelvis fragility fracture classification conservative operative