Kornimate/medical-research-clean huggingface dataset:
basophil activation test to diagnose food allergy

Conditions: Food Allergy; Food Allergy in Infants; Food Allergy in Children; Food Allergen Sensitisation; Milk Allergy; Egg Allergy; Nut Allergy

Summary: the bat ii study is a cross-sectional diagnostic study in which children with suspected ige-mediated allergy to foods (namely cow's milk, egg, sesame and cashew), as defined by a history of an immediate-type allergic reaction to a food or no history of food consumption or the presence of food-specific ige as documented by skin prick test or serum specific ige, will undergo a diagnostic work-up to confirm or refute the diagnosis of ige-mediated food allergy. participants will be prospectively recruited from specialised paediatric allergy clinics in london and will undergo skin prick testing (spt), specific ige testing to allergen extracts and allergen components, basophil activation test (bat) and oral food challenge. the diagnostic accuracy of the bat and of other allergy tests will be assessed against the clinical gold-standard.


Eligibility criteria:
inclusion criteria: 1. children ≥6 months and \<16 years old; 2. suspected ige-mediated food allergy defined by: * history of an immediate-type allergic reaction to a specific food or * no history of consumption of the specific food or * ige sensitisation documented by skin prick test (≥1 mm) or serum specific ige (≥0.10 ku/l); 3. avoidance of the specific food for at least 2 days prior to blood collection for bat and specific ige and prior to the challenge; 4. informed consent obtained from parent or guardian and assent obtained from the child. exclusion criteria: 1. clinically significant chronic illness other than atopic diseases; 2. previous history of severe life-threatening reaction to the suspected food with documented decrease in oxygen saturation (\<90%), hypotension (≥20% reduction in systolic blood pressure) and/or admission to intensive care; 3. unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge; 4. contra-indication for diagnostic food challenge, namely: * uncontrolled atopic diseases (e.g. eczema, asthma, rhinitis); * chronic medical conditions that pose significant risk in the event of anaphylaxis or treatment of anaphylaxis (e.g. cardiac disease, severe lung disease, pregnancy, mastocytosis); * inability to discontinue medications that might interfere with assessment or safety (e.g. antihistamines, β-agonists, β-blockers, nsaids, ace inhibitor, antacids); * recent (within 7-14 days) treatment with systemic steroids or prolonged high-dose systemic steroids or immunosuppressants; 5. undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment; 6. inability to stop anti-histamines prior to spt.

Keywords: food allergy milk allergy egg allergy nut allergy basophil activation test diagnosis specific ige skin prick test
safety and tolerability of ziftomenib combinations in patients with relapsed/refractory acute myeloid leukemia

Conditions: AML; AML With Mutated NPM1; Hematologic Malignancy; KMT2Ar; NPM1 Mutation; MLL Rearrangement; Leukemia; Acute Myeloid Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Acute Leukemia; Neoplasms by Histologic Type

Summary: the safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: flag-ida, low-dose cytarabine, and gilteritinib.


Eligibility criteria:
key inclusion criteria: * has been diagnosed with relapsed/refractory aml. * has a documented npm1 mutation or kmt2a rearrangement. * has a documented flt3 mutation (cohort a-3 only). * has an eastern cooperative oncology group (ecog) performance status ≤ 2. * has adequate hepatic and renal function as defined per protocol. * has an ejection fraction above a protocol defined limit. * participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. * has agreed to use contraception as defined per protocol. key exclusion criteria: * has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia. * has clinically active central nervous system leukemia. * has an active and uncontrolled infection. * has a mean corrected qt interval (qtcf) \> 480ms. * has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. * has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention. * has had major surgery within 4 weeks prior to the first dose of study intervention. * has received a hematopoietic stem cell transplant (hsct) and has not previously had adequate recovery per protocol defined criteria. * has active graft-versus-host disease (gvhd) and or on immunosuppressive drugs for the treatment of gvhd. * participant is pregnant or lactating.
effect of omega-3 fatty acid supplementation on hypertriglyceridemia in hiv-infected children

Conditions: Hypertriglyceridemia

Summary: the overall objective of this study is to evaluate the safety and efficacy of fish oil omega-3-fatty acid supplementation in treating pediatric haart-associated hypertriglyceridemia.

there are no guidelines as to the clinical threshold at which treatment for hypertriglyceridemia is necessary in pediatric populations, and extreme hypertriglyceridemia is relatively infrequent in hiv-infected children. adult studies have suggested that there is a proportionate reduction in triglycerides of approximately 15-25% when taking fish oil omega-3 fatty acid supplementation, irrespective of the degree of initial triglyceride elevation. this trial would thus represent a proof-of-concept study in children with mild to moderate hypertriglyceridemia. the results of this study would contribute to the pool of knowledge regarding the efficacy and safety of this nutriceutical in the treatment of haart-associated hypertriglyceridemia in children. compared with other interventions (such as dietary changes and drug therapies), nutritional supplementation with fish oil is an inexpensive, simple, and likely preferable treatment for a potentially significant medical condition. in addition, the results of this study could presumably be extrapolated to benefit children with hypertriglyceridemia secondary to other types of drugs or illnesses.

Eligibility criteria:
inclusion criteria: * hiv positive children aged 5-18 years on stable haart therapy for at least 6 months, with reasonable control of their hiv (viral load remaining undetectable, or stable with \<0.5 log increase in previous 3-4 months) and no plans for a change in therapy in the next year * elevated fasting triglyceride level \>1.5 mmol/l on at least two occasions within the previous year (including at least one in the last 3 months while on the current haart regimen) * ability to swallow capsules exclusion criteria: * known allergy to fish, soybean, or corn * current treatment with triglyceride-lowering agent * family history of familial hypertriglyceridemia

Keywords: omega-3 fatty acid hypertriglyceridemia hiv pediatric haart
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of amg 811 in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this first-in-human, multicenter study to evaluate the administration of placebo or amg 811 single subcutaneous and intravenous dose to subjects with sle


Eligibility criteria:
inclusion criteria: * diagnosis of sle ncluding a positive antinuclear antibodies (ana) test at least 6 months before randomization; any concurrent sle pharmacologic regimen (including leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before randomization; prednisone ≤ 20 mg/day (or equivalent) was permitted; 1 increase or decrease of ≤ 5mg/day prednisone equivalent was allowed within 30 days before randomization exclusion criteria: * subjects who, in the clinical judgment of the investigator, had severe disease; subject who had at least 1 bilag 'a' score or 2 bilag 'b' scores in any of the organ systems at screening; signs or symptoms of a viral or bacterial infection within 30 days of study randomization, or recent history of repeated infections, evidence of liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior administration of another biologic that primarily targets the immune system within 1 year
intraperitoneal ropivacaine irrigation in bariatric surgery

Conditions: Pain

Summary: a prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (lsg) or laparoscopic roux-en-y gastric bypass (lrygb) will be performed. patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation (experimental group - eg) and those undergoing intraperitoneal irrigation with normal saline (control group - cg).

a prospective randomized clinical trial of all the patients undergoing laparoscopic sleeve gastrectomy (lsg) or laparoscopic roux-en-y gastric bypass (lrygb) will be performed. patients will be randomized in 2 groups: those patients undergoing intraperitoneal ropivacaine irrigation 300mg in 200 ml(experimental group - eg) and those undergoing intraperitoneal irrigation with normal saline 200ml (control group - cg).

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>40 kg/m2 * bmi \> 35 kg/m2 with the presence of comorbidities associated to obesity. exclusion criteria: * patients undergoing other bariatric techniques or revisional surgery * allergy to local anesthetics * severe underlying cardiovascular diseases * chronic renal failure * hepatic dysfunction * previous foregut surgery * patients with any contraindication for bariatric surgery.
use of electrical impedence to measure lean body weight as a determinant of the dose of contrast media for abdominal ct

Conditions: IV Contrast Dosing

Summary: there are several different methods that can be used to determine the dose of iodinated contrast material for a ct scan. these include a standard fixed dose, a dose based on total body weight, a dose based on body mass index, a dose based on lean body weight, and a dose based on estimated lean body weight. the fixed dose method uses a predetermined amount of contrast material for all patients having a ct scan of the abdomen regardless of size. this is the standard procedure currently used at duke. the other methods use the patient's weight, either the total body weight or lean body weight, to determine the amount of contrast necessary for the ct exam. for this study, the investigators will use the fixed dose, total body weight, the lean body weight, and estimated lean body weight methods. the purpose of this study is to evaluate these five methods of determining the iv contrast volume and which may be best for abdominal ct scanning.


Eligibility criteria:
inclusion criteria: * male or non-lactating, non-pregnant females * 18 years or older who are able to give written informed consent exclusion criteria: * a chronic underlying liver disease such as cirrhosis, fatty infiltration of the liver or glycogen storage diseases * patients with a prolonged cardiac transit time such as those with a congested heart failure, a history of prior cardiac valve replacement, or restrictive/constrictive pericarditis * patients having undergone any other radiological procedure utilizing iodinated contrast with the 24 hours prior to the ct exam * patients above a certain total body weight (440 lbs.) due to limitation of the scales themselves (determined by manufacturer) * any subjects with a history of hypersensitivity to iodine-containing compounds or renal insufficiency (serum creatinine \>1.8) * subjects with implanted electronic devices (pacemakers, defibrillators, insulin pumps, etc.)

Keywords: iv contrast contrast dosing
risk of recurrent cead after pregnancy

Conditions: Cervical Artery Dissection; Pregnancy Complications

Summary: primary objective: to determine whether pregnancy increases the risk of recurrent cead and delayed stroke in women with prior cead based on long-term data. methods: multicentric, observational case-control study based on pooled individual patient data from several stroke centers. primary endpoint: primary composite outcome measure includes the following outcomes: (i) occurrence of recurrent cead, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death.

background: cervical artery dissection (cead) is a leading cause of stroke in women of childbearing age. among the population with an initial cead, about 9% show a recurrence event (a range from 0 to 25% has been reported). recurrence of cead can occur for several years after the initial event. cead has been shown to occur in association with pregnancy, and the postpartum period, yet it remains unclear whether pregnancy increases the risk of recurrence or delayed stroke. previous studies on this subject are either based on small sample sizes or lack long-term data. objective: the investigators want to determine whether pregnancy increases the risk of recurrent cead and delayed stroke in women with prior cead based on long-term data. furthermore, it will be investigated whether the mode of delivery affects recurrence and if dissections occurred during a particular phase of a woman's reproductive process. the investigators will also investigate if women actively decided against another pregnancy due to the initial cead. methods: this study will be a multicenter, exploratory case-control study using pooled individual patient data from several stroke centers. the data will be obtained through review of medical records and patient interviews. the study will include all women with any prior cead who have had long-term follow-up (at least 6 months, with no upper limit), including information about pregnancy and recurrence of cead. primary endpoint is a composite outcome measure which consists of (i) occurrence of recurrent cead, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death. secondary endpoints are the individual components of the primary endpoint and functional outcome assessed by the modified ranking scale. statistical analysis will be used to determine the odds of the primary and secondary endpoints in women who had subsequent pregnancies compared to those who did not.

Eligibility criteria:
inclusion criteria: * female * prior symptomatic cervical artery dissection (= index cead) * at least one long-term follow-up visit (at least 6 months after the initial event) * with information available on outcome events: * recurrent dissection * ischemic stroke * hemorrhagic stroke * functional outcome assessed by mrs score * with data on pregnancy after the initial event * at least 18 years old at the initial event exclusion criteria: * male patients * age \<18 years * no long-term follow-up available or long-term follow-up \< 6 months after initial event * no data on pregnancy after initial event available

Keywords: ischemic stroke hemorrhagic stroke
equity using interventions for pain and depression - pilot study

Conditions: Chronic Pain; Depression; Health Equity

Summary: this project is part of the nih helping to end addiction long-term (heal) initiative (https://heal.nih.gov/). this pilot randomized controlled trial (rct) is part of phase 1 of a two-phase, 5-year project with the overarching goal of testing a decision aid (da)/coaching intervention, tailored to black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (npts). this 2-arm pilot trial randomized 30 black patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system. after the baseline assessment, patients randomized to the intervention were asked to participate in 4 coaching sessions over approximately 12 weeks. sessions used motivational interviewing principles to foster openness to npts and self-efficacy by helping patients identify their goals and priorities, understand their npt options, prepare them to discuss and choose options with their primary care providers (pcps), and reinforce these choices to foster maintenance of these changes. da contents were integrated into these sessions, which facilitated discussion of these options with their pcp. the first 3 sessions ideally took place prior to the patient's next scheduled pcp visit; the final session occurred after this visit. assessments were conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months. patients randomized to the wait-list control group received usual care (in addition to study assessments at baseline, 3 months, and 6 months). after completing the final assessment, they were given the da and offered a 20-minute coaching session to walk them through it (patients could decline the coaching session).


Eligibility criteria:
inclusion criteria: eligible patients must: * have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, shoulder) for ≥3 months, * have at least moderate pain intensity and interference with function, defined by a score ≥4 (possible range: 0-10) on the pain, enjoyment of life and general activity scale (peg), a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity, * have at least mild depression, defined as phq-8 score ≥5, * identify as black or african american, * have consistent access to a telephone, * indicate openness to new pain treatments, and * have a scheduled appointment with their pcp in the next approximate 2-4 months exclusion criteria: patients are excluded: * if previously participated in the pi's past pilot study (irb #12885) or participation as a patient engagement panel member for this project, * if medical records indicate severe medical conditions likely precluding participation (e.g., ny heart association class iii or iv heart failure), or * if the eligibility screener reveals (1) active suicidal ideation, or (2) severe hearing/speech or cognitive impairment.

Keywords: chronic pain depression health equity shared decision making decision aid
mental practice in post-stroke subjects

Conditions: Stroke Sequelae; Stroke

Summary: among the limitations caused by cerebrovascular accident (cva), the upper limb (ms) undergoes changes that limit the individual in his ability to maintain an active social life. mental practice (mp) consists of the internal reproduction of an event, which is repeated extensively in order to learn or improve an already known skill. the objective of the study is evaluate the effects of the physical practice associated with pm, on paretic ms. subjects with unilateral stroke over 6 months, age\> 18 years and who were able to hold objects will be selected. subjects with painful conditions that affected exercise performance,\> 3 spasticity by ashworth, and cognitive deficit suggested by the mini mental state examination will be excluded.

there are 3 study protocols. the mp protocol 1 comprise 4 steps: 1) 5 minutes of global relaxation; 2) video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles); 3) mp: think about the tasks assisted in the video for 5 minutes / task. 4) physical practice: reproduce through the motor execution, the activities assisted in the video (5 minutes / task). the mp protocol 2 was the same, changing the order: first physical practice and after mp. for the protocol 3 without pm, step 3 was suppressed, remaining the remaining steps. there were 15 sessions, 2x / week, for 1 hour. the fugl-meyer (fm) scales, ashworth modified scale (ema), functional independence measurement (mif), action research arm test (arat), box and block task (bbt) and theory of mind battery (tom) will be applied before and after the sessions, and in 3 months follow-up.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age above 18 years, unilateral involvement and are able to hold objects exclusion criteria: * painful conditions that affect the ability to perform the proposed exercises, spasticity greater than 3 by the ashworth scale and cognitive deficits that will be evaluated by the mini mental state examination (mmse)
clinical, biological and nmr outcome measures study for hereditary inclusion body myopathy due to mutation of udp-n-acetylglucosamine 2-epimerase/n-acetylmannosamine kinase gene (gne)

Conditions: HIBM

Summary: the objective of the study is to identify the best clinical and biological outcome measures for further therapeutics approaches.


Eligibility criteria:
inclusion criteria: * must be at least 18 years of age. * must be willing and able to provide consent. * must have a genetic diagnosis of hibm, gne myopathy, quadriceps sparing myopathy (qsm), inclusion body myopathy type 2, distal myopathy with rimmed vacuoles (dmrv), or nonaka disease. * must be willing and able to comply with all study requirements. * affiliated to or a beneficiary of a social security category * must take part in the hibm-pmp ux001-cl401 study exclusion criteria: * received mannac therapy or other similar substance * any unrelated, comorbid disease or condition that, in the view of the investigator, would interfere with study participation or would affect safety. * patients with specific contraindication to mri (i.e. metallic foreign body, claustrophobia...) will be allowed to participate, but mri will not be performed. * pregnant women.

Keywords: hibm gne
prospective study of scheuermann's kyphosis

Conditions: Scheuermann's Kyphosis

Summary: the purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with scheuermann's kyphosis.


Eligibility criteria:
inclusion criteria: * patient age \< 21 years * male or female * diagnosis of classical scheuermann's kyphosis (3 successive vertebrae wedged 5 degrees or more, +/- end plate deformities) or idiopathic structural kyphosis (rigid structural kyphosis without classic scheuermann's kyphosis findings). * for which surgical treatment is recommended to prevent progression of the curvature or to correct trunk deformity (unacceptable cosmesis) - any deformity magnitude. or * for which surgical treatment is not being undertaken (and alternate treatment, i.e. bracing, or observation) is being pursued for any curve magnitude of clinical concerns of scheuermann's kyphosis. * inclusion criteria for anterior release (for those surgeons performing anterior release surgery): deformity magnitude = any degree and any other criteria defined by the individual surgeon. * posterior disc herniation is not an exclusion criteria from being in the study, only from being in the posterior surgery group - these patients will be defaulted to ant/post surgery. * only patients that have had a pre-op mri performed as a part of their routine care, should be included in this study. exclusion criteria: * previous operated kyphosis, scoliosis or spondylolisthesis * neuromuscular co-morbidity * post laminectomy kyphosis

Keywords: treatment outcomes spinal deformity scheuermann's kyphosis