Kornimate/medical-research-clean huggingface dataset:
aprepitant as antiemetic prophylaxis in patients with acute myeloid leukemia undergoing induction chemotherapy

Conditions: Acute Myeloid Leukemia

Summary: chemotherapy induced nausea and vomiting (cinv) is a major adverse effect of chemotherapy. this study is determining the incidence of vomiting/retching of the standard induction chemotherapy regimen for patients with acute myeloid leukemia (aml) who are also receiving an antiemetic known as aprepitant. the standard frontline chemotherapy for patients with aml consists of cytarabine given as a 7 day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on days 1-3. this is known as the 3+7 regimen. antiemetic treatments are usually given to patients for nausea and vomiting. granisetron (a 5-ht3 receptor antagonist) is used on the 3 daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting. this study will test that the prophylactic use of aprepitant, in addition to the standard antiemetic regimen used at princess margaret hospital (pmh), will reduce the incidence of delayed onset vomiting/retching by day 5 in aml patients receiving the standard 3+7 regimen, compared to retrospective data using this regimen.


Eligibility criteria:
inclusion criteria: * acute myeloid leukemia (aml), any subtype including acute promyelocytic leukemia (apl). patients with either de novo or secondary aml are eligible. * no prior aml induction chemotherapy. * due to receive standard 3+7 induction chemotherapy using daunorubicin on days 1-3, plus cytarabine continuous infusion daily on days 1-7. * age 18 and over. * serum bilirubin \< or = 1.5 times the upper limit of normal (uln). * serum aspartate aminotransferase and alanine aminotransferase \< or = 2.5 times the uln. * serum creatinine \< 200 umol/l exclusion criteria: * uncontrolled nausea or vomiting within 48 hours prior to start of induction therapy. grade 0-1 nausea is permitted at the start of induction. * known hypersensitivity to granisetron or aprepitant. * patients currently receiving treatment with strong cyp3a4 inhibitors or substrates and treatment cannot be either discontinued or switched to a different medication prior to starting study drug. * not able to swallow or absorb oral medications. * documented active central nervous system (cns) leukemia or recent cns hemorrhage. * concomitant use of: 1. other investigational agents during induction therapy 2. radiotherapy during, or one month prior to, induction therapy 3. systemic corticosteroids 4. other chemotherapy agents on days 1-8 * pregnant or breast feeding.

Keywords: aml
pk/pd of high dose pip/tazo in obese patients

Conditions: Obesity

Summary: worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. in these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. the purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. this study will also include information on the safety and tolerability of the higher dose regimens. the study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.


Eligibility criteria:
inclusion criteria: * bmi greater than or equal to 30 kg/m2 * weight at least 105 kg * age 18-89 years of age * prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s) * english or spanish speaking * central line access exclusion criteria: * do not meet specified inclusion criteria * hepatic impairment classified by child-pugh class b or greater * documented pre-existing seizure disorder * documented pre-existing hematologic disorder * pregnancy * documented allergy or contraindication to beta-lactams or tazobactam

Keywords: pharmacokinetics obesity piperacillin-tazobactam combination product pharmacodynamics piperacillin/tazobactam
nerve transfer to improve function in high level tetraplegia

Conditions: Cervical Spinal Cord Injury; Tetraplegia

Summary: the goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury. participants will: * undergo standard of care pre- and post-op testing and study exams * complete pre- and post-questionnaires * undergo standard of care nerve transfer surgeries * follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months * attend therapy at local therapist for up to 2 years postop.

restoration of function in patients with high tetraplegia has been an elusive clinical challenge. there is a critical need to find an effective reconstructive therapy/procedure which improves the upper extremity function in patients with high tetraplegia. one pure motor nerve - spinal accessory nerve (san) remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension. elbow function can provide profound independence in mobility, ventilator management and may broaden the application of assistive therapies. the two objectives of this study are: * determine if san nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients. * determine if san nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia. study activities (including standard of care (soc)) * electrodiagnosis pre-op (soc) * upper extremity maximum muscle testing (soc) * questionnaires (soc and study-related (sr)) * exams by a study therapist (sr) * neurological exam - isncsci - (soc) * nerve transfer surgery to be determined by surgeon (soc) * follow-up visits with surgeon at 6/12/18/24/36 and potentially 48 months * post-op electrodiagnostic testing (sr) * post-op upper extremity maximum muscle testing (soc) * post-op questionnaires * post-op therapy exams (sr)

Eligibility criteria:
inclusion criteria: * 18-80 years of age * high cervical sci (motor level c1-c4) * motor complete sci ais grade a-b * plateaued spontaneous recovery for at least 6 months of non-operative therapy * sci greater than 6 months and fewer than 60 months since injury * at least mrc 4/5 donor strength * mentally and physically willing and able to comply with evaluations exclusion criteria: * active infection at the operative site or systemic infection * any return or ongoing recovery of distal motor function * significant joint contractures and/or limitations in passive range of motion in the arm * mentally or physically compromised making it impossible to complete study activities * immunologically suppressed * currently undergoing long-term steroid therapy * active malignancy * pregnancy

Keywords: spinal cord injury cervical spinal cord injury nerve transfer surgery high cervical spinal cord injury cervical sci tetraplegia quadriplegia nerve transfer spinal accessory nerve
pain management of intensive care unit patients

Conditions: Pain

Summary: the purpose of this study is to evaluate the effect of an algorithm, where icu patients pain are assessed systematically with valid pain assessment tools and where pain is treated after pain intensity score.

as a pre-test, before the intervention is introduced, data from icu patients from four intensive care units (icu) will be collected from medical records to evaluate current pain management practices. an algorithm, which is developed by a group of resource persons, is educated to the staff in three of the icus. the staff will also receive training and guiding in the use of the algorithm and the different pain assessment tools. then the algorithm will be implemented and used in all the consecutive icu patients. post-test data is then collected in the three icus. in the fourth icu, which will be used as a comparison unit, the same post-test data will be collected at the same time as data in intervention icus were collected. the algorithm will not be introduced here.

Eligibility criteria:
inclusion criteria: * all consecutive patients admitted into these four icus exclusion criteria: * patients will be excluded if they are not able to express pain behaviors (i.e. quadriplegic, are receiving neuromuscular blockade or muscle paralyzing drugs or are being investigated for brain death.

Keywords: pain management pain assessment intensive care unit adult
effects of tdcs in m1 and dlpfc on pain processing in healthy volunteers

Conditions: Pain Processing in Healthy Volunteers

Summary: the purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years * comprehension of the study tasks exclusion criteria: * presence of pain in the previous 6 months * altered sensitivity in the tested regions * intolerance to electrotherapy * presence of pacemakers or any other implanted device * ulcers or scars in the skin at the location of the electrodes * treatment with direct current stimulation within one week * pregnancy * frequent headaches * epilepsy * history of neuromuscular disease * previous clinical history of cervical surgery * injuries or surgery affecting the upper limb * diabetes mellitus * cardiovascular diseases * oncological diseases * consumption of analgesic drugs 7 days before the study
generic substitution of original levetiracetam in thai epilepsy patients

Conditions: Epilepsy

Summary: the retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in thailand. epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. in the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.


Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution; * same dosage form and strength of generic substitution to original levetiracetam; * stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution; * stable dose of generic levetiracetam after generic levetiracetam substitution exclusion criteria: * absence seizure with levetiracetam monotherapy; * original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution; * poor compliance; * death or loss of follow up; * unavailable data for evaluation of outcomes

Keywords: epilepsy generic levetiracetam therapeutic equivalency
a multiple ascending dose study of safety and pharmacokinetics of np10679 in normal healthy volunteers

Conditions: Stroke, Ischemic; Pain, Postoperative; Substance Abuse; Subarachnoid Hemorrhage

Summary: this multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of np10679 when delivered intravenously in escalating dose levels in comparison to placebo.

np10679 is a ph dependent inhibitor of the glun2b subtype of the nmda receptor. compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with stroke, subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. this study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of 5 once daily doses of np10679 when delivered intravenously in three escalating dose levels in comparison to placebo

Eligibility criteria:
inclusion criteria: * male and female subjects aged 18 to 55 years * ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments. * if of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study. exclusion criteria: * clinical laboratory values greater than or equal to 2 times the upper limit of normal. * recent history (within 2 yrs) or current tobacco use.

Keywords: nmda glun2b
improving door-to-balloon time in stemi

Conditions: Myocardial Infarction

Summary: the investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse.

please see circulation. 2007;116:67-76

Eligibility criteria:
primary study inclusion criteria: * st-elevation myocardial infarction patients who undergo percutaneous intervention within 24 hours of ed arrival exclusion criteria: * patients who are inpatients a registry of all patients who undergo emergency cardiac catheterization irrespective of etiology is maintained.
erythema migrans in elderly

Conditions: Lyme Disease; Erythema Migrans; Elderly Infection

Summary: the investigators will focus on elderly patients with early lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of lyme borreliosis.


Eligibility criteria:
inclusion criteria: * erythema migrans exclusion criteria: * pregnancy or lactation * immunocompromised * taking antibiotic with antiborrelial activity within 10 days * received \<10 days of antibiotic therapy for erythema migrans * had an intercurrent episode of lyme borreliosis during follow-up
paricalcitol for the treatment of immunoglobulin a nephropathy

Conditions: IgA Nephropathy

Summary: immunoglobulin a (iga) nephropathy is the common type of primary glomerulonephritis in the world. a wealth of literature suggests that vitamin d and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. however, calcitriol, the standard form of vitamin d, carries a substantial risk of hypercalcemia. recently, paricalcitol (19-nor-1,25-dihydroxyvitamin d2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much lower than calcitriol. therefore, the investigators plan to conduct a randomized cross-over study to evaluate the efficacy of paricalcitol in the treatment of iga nephropathy. thirty patients with biopsy-proven iga nephropathy will be recruited. they will be randomized to paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a washout period. proteinuria, renal function, serum and urinary inflammatory markers will be monitored. this study will explore the potential anti-proteinuric and anti-inflammatory effects of paricalcitol in the treatment of iga nephropathy, which has no specific treatment at present.


Eligibility criteria:
inclusion criteria: * aged 18-65 years * biopsy-confirmed iga nephropathy * proteinuria \> 1 g/day (or proteinuria \> 1 g/g-cr) in 3 consecutive samples within 12 weeks despite ace inhibitor or angiotensin receptor blocker treatment (e.g. ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months * estimated glomerular filtration rate \> 60 ml/min/1.73m2 * corrected serum calcium level \> or = 2.45 mmol/l * willingness to give written consent and comply with the study protocol exclusion criteria: * pregnancy, lactating or childbearing potential without effective method of birth control * severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication * history of malignancy, including leukemia and lymphoma within the past 2 years * systemic infection requiring therapy at study entry * any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension * history of drug or alcohol abuse within past 2 years * participation in any previous trial on paricalcitol * patients receiving treatment of vitamin d and/or its analogue for other medical reasons within the past 3 months * patients receiving treatment of corticosteroid * on other investigational drugs within last 30 days * history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study * history of non-compliance * known history of sensitivity or allergy to paricalcitol or other vitamin d analogs
molecular detection of antibiotic resistance and h pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: h pylori eradication failure with recommended triple therapy is mainly related to antibiotic resistance. however,in vitro culture of h pylori is uneasy and is not performed in routine practice. a molecular test of antibiotic resistance easy to perform is now available. the aim of the study was to compare eradication rates obtained with the standard treatment and with a treatment guided by the results of the molecular detection of antibiotic resistance.

at the present time, h pylori infection is treated with a standard triple therapy. treatment of naïve patients with triple therapy ( ppi+amoxicillin+clarithromycin for 7 days) markedly decreased last years to reach 70% due to a clarithromycin resistance rate about 20% in france. in case of failure, the recommended second line treatment (ppi+amoxicillin+metronidazole for 14 days) gives a success rate of 60%. however, as culture is uneasy and is only possible in specialised labs sensitivity to antibiotics is not currently studied before treatment. the aim of the study was to evaluate clinical and medico-economic benefit of the molecular detection of antibiotic resistance in order to guide the treatment. the test is performed after dna extraction from biopsy specimens taken at gastroscopy allowing rapid detection of h pylori and clarithromycin or quinolone resistance. patients with bacteriologically proven h pylori infection will be randomly allocated to either empirical usual treatment with ppi , amoxicillin 1g, clarithromycin 500 mg x 2 /day for 7 days in naïve patients and ppi, amoxicillin 1g,metronidazole 500 mg x 2 /day for 14 days in patients who failed a first line treatment , or to treatment guided by the molecular test: ppi , amoxicillin 1g, clarithromycin 500 mg x 2 /day for 7 days in case of sensitivity to clarithromycin.in case of resistance to clarithromycin, quinolone should be given and in case of resistance to quinolone clarithromycin should be given. in case of resistance to both antibiotics metronidazole should be given. eradication will be assessed by performing 4 weeks after the completion of treatment with urea breath test.

Eligibility criteria:
inclusion criteria: * h pylori infection bacteriologically confirmed * age \> 18 years * naïve patient or one failure of the first line recommended treatment * patient referred to one out of the centres participating in the study exclusion criteria: * h pylori positive patient with at least failure of two lies of treatment * patients with previous adverse event with ppi, amoxicillin, clarithromycin, levofloxacin or metronidazole * ppi or antibiotic treatment in progressor stopped for less than 4 weeks * patient with other severe sickness

Keywords: helicobacter pylori diagnostic molecular testing antibiotic resistance treatment protocols
evaluating chronic pain self-management support with an opioid de-prescribing intervention

Conditions: Chronic Pain

Summary: this study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach

chronic pain is a burden on individuals, the health system, and society. opioid prescriptions have increased over three decades with the aim of reducing the burden of chronic pain. unfortunately, increases in opioids have not improved functional outcomes for people with pain and opioid related side-effects and deaths have accompanied the rise in use. opioid deprescribing (reducing the dose or transitioning off of opioids) has the potential to improve health outcomes for people on opioids for chronic pain. one of the evidence based approaches to deprescribing includes providing an interdisciplinary pain program for individuals to help manage their pain as they reduce their dose or transition off of opioids. unfortunately, the inability to access multidisciplinary pain programs is a barrier faced by most people living with pain and their primary care providers. self-management support has been shown to improve pain and function for people with chronic pain and may be more feasible to offer in primary care to support people as they try to reduce their dose or transition off of opioids. evidence on the outcomes of pairing self-management support with opioid deprescribing is lacking, however. this study will evaluate the outcomes of the combination of chronic pain self-management support with opioid deprescription, improve our understanding of the experiences and perspectives of patients and healthcare providers with this approach, and determine the characteristics of people on opioids in primary care to inform future research and implementation of this approach. if effective, this approach could be implemented more widely. the results of this study, therefore, have the potential to improve health outcomes for people taking opioid medications for chronic pain.

Eligibility criteria:
inclusion criteria: * chronic pain for \>3months * on opioid medications with a dose of at least 50 milligram morphine equivalents per day * ability to communicate effectively using the english language, including reading and writing exclusion criteria: - chronic pain due to cancer