Kornimate/medical-research-clean huggingface dataset:
pharmacological study of high doses of ceftriaxone in meningitidis

Conditions: Meningitis; Neurological Infections

Summary: the aim of the study is to describe the concentrations of ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. additionally, we aimed to detect adverse effect, especially neurological trouble related to ceftriaxone toxicity.

day 0 : onset of treatment by ceftriaxone, following usual therapeutic process (french guideline) from day 0 to day 4 : inclusion, clinical and biological data collection, electroencephalogram at baseline. two samples for ceftriaxone concentration monitoring : * trough concentration of ceftriaxone at steady state * a random sample (population pk) at the end of ceftriaxone treatment : assessment of tolerance and efficacy of the treatment.

Eligibility criteria:
inclusion criteria: * hospitalized adults patients, * age equal or above 18 * patients with community or surgical acquired neurological infections, meningitis and others * prescription of ceftriaxone \>75mg/kg/d or \>4g/d - * subjects affiliated to french health insurance (social security) * informed consent form signed exclusion criteria: - patient under guardianship

Keywords: ceftriaxone adverse drug effects therapeutic monitoring meningitis
q10 preloading before cardiac surgery for kidney failure reduction

Conditions: Acute Kidney Injury; Acute Kidney Failure

Summary: coenzyme q10 (coq10) is an essential molecule in human body. it acts as an antioxidant, a co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of improving endothelial function. our goal is to investigate whether coq10 is capable to reduce the incidence of acute kidney injury/failure following cardiac surgery. cardiac surgery is major risk factor for acute kidney injury/failure (aki/f).


Eligibility criteria:
inclusion criteria: * adult patients scheduled for elective cardiac surgery exclusion criteria: * patients receiving high dose vitamin b supplementation (defined as more that 200% of recommended daily allowances) * patients under warfarin therapy * urgent surgery * end stage kidney disease * therapy with multiple nephrotoxic drugs * chronic kidney disease * obstructive uropathy * previous cardiac surgery procedure * alcohol abuse * malignancy * allergy to any ingredient of myoqinon capsule * patients receiving myoqinon and fail to demonstrate a significant increase in blood concentration of q10 * uncontrolled hypertension
a pharmacokinetic (pk) study of natalizumab (tysabri) at steady state

Conditions: Multiple Sclerosis

Summary: the primary objective is to assess the pharmacokinetic (pk) profile of natalizumab (tysabri) at steady state. the secondary objective is to assess the pharmacodynamics (pd) profile (α4 integrin saturation) of tysabri at steady state.


Eligibility criteria:
key inclusion criteria: * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. * must be a multiple sclerosis (ms) patient enrolled in the tysabri outreach: united commitment to health prescribing program (touch) who is not expected to discontinue tysabri therapy prior to completion of the requirements of this study. * must have been treated with monthly iv infusions of tysabri 300 mg for at least 12 months, with the 9 most recent doses having been administered at 28±7 day intervals. * must test negative for antibodies to tysabri at the screening visit. * must have a magnetic resonance imaging (mri) brain scan, performed prior to the initiation of treatment with tysabri, on file. * must weigh between 42 and 126 kg, inclusive. * all male subjects and female subjects of childbearing potential must practice effective contraception during the study. key exclusion criteria: * history of, or abnormal laboratory results indicative of, any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, and renal, or other major disease, as determined by the investigator. * positive result for antibodies to tysabri at any prior evaluation. * treatment with an investigational product or approved therapy for investigational use within 6 months prior to the start of pk sample collection or during the course of this study. concurrent participation in an observational study (e.g., tysabri global observational program in safety \[tygris\]) is permitted. * pre-scheduled for any elective procedure or medical treatment during the study period. * history of drug or alcohol abuse (as defined by the investigator) within 2 years prior to the screening visit. * female subjects who are breastfeeding, pregnant, or planning to become pregnant while on study. * alcohol use within 24 hours prior to the baseline visit. * inability or unwillingness to comply with study requirements, including the presence of any condition (e.g., physical, mental, social) that is likely to affect the subject's ability to comply with the study protocol. * other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ms multiple sclerosis
merkel positron emission tomography (pet) protocol

Conditions: Merkel Cell Carcinoma

Summary: a phase ii study designed to evaluate the efficacy of chemo-radiotherapy in achieving loco-regional control in patients with merkel cell carcinoma (mcc) of the skin. patients will undergo pet scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.


Eligibility criteria:
inclusion criteria for trial registration: patients may be registered on the trial only if they meet all of the following criteria: * age 18 years or older * written informed consent to participate in the study * able to undergo 18-fdg pet scan (no uncontrolled diabetes mellitus or severe claustrophobia). * available for follow-up. * using adequate contraception if capable of child bearing * any merkel cell carcinoma confined to the primary and/or nodal sites * ecog 0-2. * full blood count (fbc) should be satisfactory ( haemoglobin \> or equal to 10g/dl, neutrophils \> or equal to 2.0 x 109 /l and platelets \> or equal to 100 x 109 /l) and renal function (gfr \> or equal to 50 ml/min) and hepatic function ( alt \< 5 x upper limit normal, bilirubin \< 1.5 x upper limit normal) * patients must be able to tolerate protocol treatment exclusion criteria for registration: * previous chemotherapy in the past 5 years or prior radiotherapy to the area of concern * unable to comply with treatment protocol eg dementia * other malignancy in the past 5 years other than non-melanoma skin cancer. * women who are pregnant or lactating. * clinical evidence of metastatic disease. * immunosuppression from long term steroid use or immunosuppressive drugs. * any serious illness or medical condition that precludes the safe administration of the chemotherapy including: 1. active infection 2. uncontrolled or unstable cardiac disease including unstable angina, myocardial infarction within the last 3 months, and recurrent ventricular arrhythmias inclusion criteria for treatment registration: patients may proceed to protocol treatment if they meet the following criteria: * high risk disease with no evidence of distant spread: biopsy proven mcc with a primary that is \> 2cm (t2n0m0= stage ii) and/or regional nodes (any t, n1m0= stage iii); or recurrent mcc not previously treated with radiation treatment; dermal or in-transit metastasis with or without nodes; occult primary with involved nodes * patients who have no metastases on ct or pet scan or if ct is suggestive of metastases, they must be pet negative

Keywords: merkel cell cancer pet scanning
sativex versus placebo when added to existing treatment for central neuropathic pain in ms

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. this type of pain "central neuropathic pain" is described as shooting, stabbing, burning or searing like sensation, which is often worse at night.

gw has shown in phase ii and iii studies that sativex has analgesic properties that are effective in relieving neuropathic pain. these studies suggested that sativex is well tolerated and may also improve sleep and quality of life. gw is conducting this study to further demonstrate these effects.

Eligibility criteria:
inclusion criteria: * any disease sub-type of ms of at least two years duration * central neuropathic pain (cnp) of at least three months and expected to remain stable for the study duration * moderate cnp defined by nrs pain score at baseline sum to at least 24 * subject established on or previously tried and failed analgesic therapy for cnp * if receiving disease modifying medications, stable dose for 3 months and maintained for study duration exclusion criteria: * subjects whose identified pain is likely to be nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal neuralgia. * other non central neuropathic pain of a severity which is likely to interfere with the patients assessment of cnp * medical history suggests subject is likely to relapse/remit during course of study * history of schizophrenia (including family history), other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with ms * known or suspected history of alcohol abuse, epilepsy or recurrent seizures or hypersensitivity to cannabinoids * travel outside of the country of residence planned during the study * significant cardiac, renal or hepatic impairment * subjects with current recreational cannabis, medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration of the study

Keywords: central neuropathic pain
capturer pmcf study ( repic04d )

Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease

Summary: multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of capturer to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with capturer .

the objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the capturer in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: * patient treated with capturer according to routine hospital practice and following instructions for use * informed consent signed exclusion criteria: * not meet inclusion criteria

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) thrombus extraction catheter
comparison between budesonide and dexamethasone treatments for respiratory discomfort after extubation on children

Conditions: Stridor

Summary: the study aims to analyze and compare the clinical effects of using inhaled budesonide or intravenous dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at hospital municipal do m´boi mirim and hospital albert einstein.

the investigators propose to perform a prospective, randomized, controlled and double-blind non inferiority study enrolling 70 children with postextubation stridor. the population will be divided in two groups: group 1 will receive inhaled budesonide and iv ns (intravenous normal saline) and group 2 will receive iv (intravenous) dexamethasone and inhaled normal saline. the study aims to analyze and compare (i would just say compare) the clinical effects of using inhaled budesonide or iv dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at hospital municipal do m´boi mirim and hospital albert einstein.

Eligibility criteria:
inclusion criteria: * patients intubated for periods longer than 24hs * age between 28 days and than 15 years * post extubation stridor must be clinically diagnosticated by a md * informed consent must be obtained exclusion criteria: * patients under palliative care * presence of neuromuscular disease * previous airway pathologies * epiglottitis, aspiration of foreign bodies * viral laryngitis * former airway surgery * patients previously included in the study within the same hospital admission * corticosteroid use in the 48hs preceding extubation

Keywords: stridor laryngitis budesonide dexamethasone children
club fit: physical activity and healthy eating at an after school program

Conditions: Childhood Obesity; Physical Activity; Dietary Habits

Summary: background: youth from low-income and minority families are disproportionately affected by obesity and its complications. this study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a boys \& girls club (bgc) after school program. methods: using a community-based participatory approach, bgc staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. preliminary intervention efficacy was assessed through a single group, pre-post study design with measured collected at baseline and 6 months.


Eligibility criteria:
inclusion criteria: - active boys \& girls club participation, which was defined as expected club attendance at least twice weekly. exclusion criteria: - none

Keywords: community based participatory research childhood obesity
health improvement after pregnancy (hip) program randomized control trial

Conditions: Metabolic Cardiovascular Syndrome

Summary: recent canadian studies, public opinion polls and the canadian heart health strategy and action plan state that women's heart health is a key national priority; it should be addressed through improving heart health awareness and prevention, and reducing care inequities for women in general and younger women in particular. the investigators have developed an innovative and interactive mobile website based postpartum lifestyle modification program (regular physical activity and nutritional guidance), based on established national guidelines, to improve heart disease risk factors in women. the investigators will conduct a trial to determine if the mobile website based lifestyle modification program can be maintained and reduces a collection of risk factors, which occurring together, greatly increases the risk of developing heart disease. the investigators hypothesize that the interactive mobile website directing regular physical activity and personalized nutritional guidance, compared to standard postpartum care, will be motivational and result in a reduced modified metabolic syndrome z score at 8 months postpartum among the intervention group.


Eligibility criteria:
inclusion criteria: - must own or have daily access to one or more of the following; smart phone, tablet or laptop computer exclusion criteria: * living greater than 100km from kingston general hospital * having an existing and long term contraindication to exercise at the time of recruitment

Keywords: postpartum preeclampsia gestational hypertension gestational diabetes exercise intervention dietary intervention behavioral intervention mobile website mobile application
chemoreflex gain on exercise

Conditions: Exertional Periodic Breathing

Summary: the purpose of this study is to assess chemoreflex gain on exercise.

normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (co2) in the blood. the change in breathing that results from a change in the blood's co2 concentration is called the chemoreflex. in heart failure, a condition where the heart muscle is damaged and can not pump as well, this reflex is exaggerated. the result of this can be breathing conditions characterised by patients hyperventilating at times and at other times taking very shallow breaths or even stopping altogether. in the past the only way of measuring this chemoreflex was to get patients to breathe into a large container and to rebreathe their exhaled air and allow the co2 to rise over time, whilst keeping the oxygen constant. the proportion by which the ventilation increases with increasing carbon dioxide is the chemoreflex gain. unfortunately, because this test takes a long time to conduct, requires specialist knowledge and equipment it has not been possible to measure this reflex on exercise.

Eligibility criteria:
inclusion criteria: * volunteers: males aged 18-80 years who are able to perform both running and cycling and can follow simple visual instructions. * heart failure subjects: males aged 18-80 with a clinical diagnosis of heart failure who are able to perform both running and cycling and can follow simple visual instructions. exclusion criteria: * chest pain of any cause within 4-6 days, * pulmonary oedema, * uncontrolled hypertension (systolic blood pressure \> 220 mm hg, diastolic \>120 mm hg), * severe aortic stenosis, * severe hypertrophic obstructive cardiomyopathy, * untreated life threatening arrhythmia, * dissecting aneurysm, * recent surgery (within 4-6 weeks), copd.

Keywords: chemosensitivity
5-year follow-up safety and performance evaluation of the medtentia annuloplasty ring in adults

Conditions: Mitral Regurgitation; Mitral Insufficiency

Summary: single-center clinical investigation is to evaluate long-term safety and performance of the medtentia annuloplasty ring (mar) in 11 patients who underwent successful mitral valve (mv) surgery using medtentia's mar system in clinical investigation 2010-040 performed during june 2011 - april 2016.


Eligibility criteria:
inclusion criteria: * signed informed consent form. * subject had a successful mar implantation in clinical investigation 2010-040. * subject is willing to participate in the follow-up study and to comply with the requirements of the clinical investigation plan. exclusion criteria: * subjects who participated in the clinical investigation 2010-040 but had the mar replaced with another mitral valve repair ring or system.

Keywords: mitral valve mitral surgery mitral repair mitral annuloplasty mitral valve surgery mitral valve repair mitral valve annuloplasty
effect of nebulized bronchodilators on heart rate

Conditions: COPD; Sepsis; Shock

Summary: the purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.

a randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. group a received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. group b received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. all patients received nebulized ipratropium bromide 500 micrograms with each treatment. heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. any new rhythm abnormalities between treatments were also recorded.

Eligibility criteria:
inclusion criteria: * adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions exclusion criteria: * known allergy or sensitivity to study medications * baseline heart rate was greater than 110 beats per minute

Keywords: tachycardia tachyarrhythmias bronchodilator therapy critically ill patients
the thoracic peri-operative integrative surgical care evaluation (poise) trial- stage i

Conditions: Lung Neoplasms; Esophageal Neoplasms; Stomach Neoplasms

Summary: stage i of the thoracic-poise study will pilot-test a broad-based, multi-agent integrative care intervention delivered by naturopathic doctors in conjunction with standard surgical and oncologic care of people with thoracic cancer.

despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. these issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (hrqol). on a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. the thoracic-poise project has the overarching goal of improving care for thoracic cancer patients by impacting hrqol, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery. this multi-stage project aims to design, pilot-test and evaluate a broad-based, multi-agent, evidence-based integrative care program to be delivered by naturopathic doctors (nd) in conjunction with standard surgical and oncologic care. it is hypothesized that this integrative care program will improve hrqol as well as reduce surgical adverse events and improve cancer survival. stage i of the project will pilot-test the intervention and outcomes collection in a single-arm, feasibility study.

Eligibility criteria:
inclusion criteria: * adults eligible and scheduled for major thoracic surgery for lung, gastric or esophageal cancer * candidate for complete resection * willingness to include an integrative component to their care * availability for follow-up visits over the course of one year * willingness to be interviewed regarding their experience of care * ability to answer self- and interviewer- administered questions in english or french * understand and sign a written informed consent form in english or french exclusion criteria: * small cell, carcinoid, or gastrointestinal stromal (gist) tumours * history of cancer in the last 3 years * already seeing a nd or involved in an integrative program of care in the last 3 months that includes complementary medicine