Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of intravenous metamizole in children less than 6 years old

Conditions: Children; Pain; Surgery

Summary: this study aims to assess the pk parameters of metamizole following a single iv administration of metamizole in children less than 6 years of age.

this is an open-label pharmacokinetics (pk) study. it aims to assess the pk parameters of metamizole and its metabolites following a single iv administration of metamizole (10mg/kg) in children less than 6 years of age. thirty-nine children, 3-72 months of age, undergoing elective surgery at the university of basel children's hospital, will receive, on the day of surgical procedure, a single dose of metamizole 10 mg/kg. after this dose, blood and saliva samples will be obtained at predetermined post-dose time points to measure concentrations of metamizole and its metabolites. the maximal duration of subject participation will be 24 hours. plasma pk parameters (auc, cmax, tmax, t1/2) of each analyte will be derived using noncompartmental methods. a population pk approach will be applied to characterize inter-subject variability and quantify the potential influence of age, sex and body weight on the pk parameters. there are no published pharmacokinetic studies of metamizole in pediatrics. furthermore, although swissmedic provides no dose information for iv administration in infants with a body weight of less than 9 kg, iv is the most frequently used route of administration for direct postoperative analgesia in pediatrics, including infants with body weights of less than 9 kg. due to the absence of data and the lack of any dosing recommendation for infants with a body weight less than 9 kg, the iv administration of metamizole in infants is "off-label" and inconsistent across hospitals and prescribing paediatricians.

Eligibility criteria:
inclusion criteria: * infants and children 3-72 months of age at time of inclusion * body weight more than 5 kg at time of inclusion * children undergoing elective surgery at university of basel children's hospital (ukbb) with planned administration of intravenous analgesia * patients who require surgical procedures that necessitate at least 24 hours in the hospital * parent/legal guardian has been informed about the study and has signed informed consent form exclusion criteria: * infants and children who were born prematurely (before 37 weeks gestation), regardless of corrected gestational age * known kidney or liver disease * known neutropenia, anemia or other hematological disorders * known diagnosis of asthma * ongoing immunosuppression, except corticosteroid treatment, or primary immunodeficiency * treatment with strong inhibitors or inducers of cyp2c19 within 3 months prior to study * treatment with drugs known to induce agranulocytosis within 3 months prior to study * documented previous adverse reaction to metamizole * treatment with metamizole within 30 days prior to screening * any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study * family members of investigators
preventive intervention against lymphedema after breast cancer surgery

Conditions: Breast Neoplasms

Summary: this study will examine whether lymphedema after breast cancer surgery can be reduced. in a randomised controlled design the aim is to investigate whether an early intervention with progressive resistance training and close monitoring of arm swelling can reduce the incidence of lymphedema after breast cancer surgery.

lymphedema is a well known and much dreaded complication after breast cancer surgery. the aim in this study is to examine if lymphedema can be prevented with early progressive strength training focusing on the arm, and close monitoring of pre clinical lymphedema in the 1 year exercise period. the primary outcome is lymphedema, and secondary outcomes are pain, self-reported symptoms of swelling, sensory disturbance, physical and psychological functioning, fatigue, depression, anxiety and health related quality of life. 158 patients operated for breast cancer with axillary node dissection, will be invited from three hospitals in denmark, sealand (rigshospitalet, ringsted hospital, and herlev hospital), while on the surgical wards. two weeks later upon consent they are recruited, baseline tested and randomized to either exercise intervention or usual care control. the exercise intervention consists of progressive resistance training, combined with a stretching programme, with a total duration of 60 minutes per session. the group attend supervised exercises twice a week and a once weekly home exercise programme of 45 to 60 minutes duration. after 20 weeks, exercises are converted to home exercises, and they are monitored by a weekly sms-service. at 12 months, follow-up measurements are taken for both groups. lymphedema is defined as 3% limb volume change from the baseline measurement.

Eligibility criteria:
inclusion criteria: * invasive unilateral breast cancer * undergone axillary lymph node dissection (alnd), planned for radiotherapy * danish speaking * consent to participate and to be randomized to either study arm. exclusion criteria: * have undergone primary breast reconstruction * distant metastases * physically unable to participate for any reason * mental illness or cognitive impairment (dementia etc.) * no past history of lymphedema diagnosis or treatment * not previously operated with axillary lymph node dissection either side

Keywords: breast cancer surgery axillary lymph node dissection resistance training breast cancer related lymphedema
a study of induction dosing with pegasys (peginterferon alfa-2a [40kd]) plus copegus in treatment-naive patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this 4-arm study will compare the efficacy and safety of pegasys induction and maintenance dosing, versus standard fixed dosing in combination with copegus, and the efficacy and safety of higher dose versus standard dose copegus in combination with pegasys. patients with chronic hepatitis c (chc) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) pegasys 180 µg subcutaneously (sc) weekly plus copegus 1200 mg orally (po) daily; b) pegasys 180 µg sc weekly plus copegus 1400-1600 mg po daily; c)pegasys 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus copegus 1200 mg po daily; or d) pegasys 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus copegus 1400-1600 mg po daily. following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, ≥18 years of age * chc infection, genotype 1 * hepatitis c virus (hcv) rna ≥400,000 iu/ml * baseline body weight ≥85 kg * liver biopsy (within 24 months of first dose) with results consistent with chc exclusion criteria: * previous treatment with interferon, ribavirin, viramidine, levovirin, hcv polymerase or protease inhibitors * other forms of liver disease, including liver cancer * human immunodeficiency virus infection
vytorin in the treatment of alopecia areata

Conditions: Alopecia Areata

Summary: subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth. the investigators hypothesize that vytorin medication may have an effect on the inflammatory process of alopecia areata. inactivating the inflammatory process may help in permitting hair regrowth in those subjects.

primary objective: to evaluate the efficacy of oral simvastatin + ezetimibe (vytorin) in treating alopecia areata in subjects 18 years and older. secondary objective: to investigate the presence of heat shock proteins in alopecia areata subjects, before and after treatment with oral simvastatin. subjects will be asked to take vytorin 10/40 for a period of 24 or 52 weeks and monitored for progression of hair regrowth. they will have lipids, creatinine kinase (ck), liver function tests (lfts), obtained on baseline visit prior to starting the medication and at visit 2, week 8. lfts will be continuously monitored at visit 4, 7, week 24 and week 40. in case of muscular pain or tenderness the medication will be stopped immediately. in most cases, muscle symptoms and ck increases resolved when simvastatin treatment was promptly discontinued. all adverse events will be recorded the investigators are going to exclude: ochildren less than 18 years * pregnant women * lactating women * subjects with kidney, liver or muscle disease * allergy to the drug or its components. subjects with history of uncontrolled hypothyroidism, the investigators hypothesize that this medication may have an effect on the inflammatory process of alopecia areata. inactivating the inflammatory cascade may help in permitting hair regrowth in those subjects.

Eligibility criteria:
inclusion criteria: * 40-80% hair loss. * clinical diagnosis of alopecia areata * 18-years or older exclusion criteria: 1. you are less than 18 years old 2. you are pregnant or planning to be pregnant during the next 12 months. 3. you are nursing a child. 4. you have kidney, liver or muscle disease. 5. you have an allergy to lidocaine, the study drug or its components. 6. you are presently participating in another clinical trial 7. you are currently using, or have used within the past 3 months, the following: * systemic corticosteroids. (prednisone, methylprednisolone, hydrocortisone etc.) * immunosuppressant agents.(cyclosporine, efalizumab etc.) * any medication that may have interaction with vytorin (check with the study doctor for other medications you are taking). 8. you are currently using, or have used within the past 2 weeks, any topical medication for the treatment of alopecia areata 9. you have an ongoing hypothyroid problem that is not being treated. if this problem is being treated then you can participate.

Keywords: alopecia areata vytorin statin hair growth
premavision cohort follow-up

Conditions: Visual Disorder

Summary: this study aim at following a cohort of prematurely born infants at 18 months corrected age, 4 and 7 years of age. this cohort had an evaluation of visual maturation at term equivalent age (tea) with factors associated with impaired visual maturation. (premavision-clinicaltrials.gov id: nct02890251). in this follow-up study, prematurely born infants vision will be compared to term born infants matched for postnatal age.


Eligibility criteria:
inclusion criteria: * infants included in the premavision cohort * term born healthy control infants at matched postnatal age exclusion criteria: * ocular malformation * genetic abnormality * neurodevelopmental impairment

Keywords: infant prematurely born maturation
local recurrence due to rectal cancer in sweden

Conditions: Rectal Neoplasms

Summary: the aim of this retrospective national registry study is to validate the reporting of local recurrence in the registry. another aim is to identify preoperative risk factors for local recurrence. this can in turn indicate the need for a more intense follow-up. the treatment of local recurrence, including the impact of the multidisciplinary team conference (mdt) and the surgical procedure and the referral pathways of local recurrences will also be determined. we aim to evaluate treatment outcome after local recurrence for patients operated or treated between 2007-2018.


Eligibility criteria:
inclusion criteria: * rectal cancer with a curative intent exclusion criteria: * rectal cancer without curative intent
reclaiming indigenous food and health

Conditions: Obesity; Overweight; Diabetes; Hypertension

Summary: the overall purpose of this proposed action-research project is to measure the feasibility of consuming and the impact of indigenous plants and foods on health outcomes among native american participants.

the overall purpose of this proposed action-research project is to measure the feasibility of consuming and the impact of indigenous plants and foods on health outcomes among native american participants on the wind river indian reservation (wrir) in wyoming. participants from the wrir will be recruited to pilot a randomized control trial (rct) with a delayed intervention to measure the impacts of consuming a diet that is 50% indigenous foods (based on participant total energy needs and recommended dietary pattern). specific objectives of the pilot rct will be to: (1) evaluate the feasibility of access, collection, and consumption of indigenous plants/animals, (2) define precisely what constitutes a "50% indigenous food diet" that will be supplied as the intervention in this trial, (3) quantify the time commitment and logistical challenges to access and collect indigenous foods, (4) evaluate the consumption of indigenous foods on health outcomes including waist circumference, body mass index, blood pressure, blood glucose control, and blood lipid levels, and (5) evaluate the impact of consuming indigenous foods on cultural identity. the pilot rct will primarily address objectives 4 and 5. in order to meet these specific objectives, the investigators will pilot a rct with delayed intervention to provisionally assess health impacts of consuming a diet that is 50% indigenous foods for four weeks. health outcomes assessed will include biometric measures of waist circumference, body mass index, blood pressure, hemoglobin a1c, total cholesterol with triglycerides; and survey measures of quality of life, cultural identification, and food security.

Eligibility criteria:
inclusion criteria: * self-identify as living within the boundaries of wrir (including the city of riverton) * self-identify as an enrolled member of the eastern shoshone or shoshone bannock tribe * be interested in following a 50% traditional diet for 4 weeks * 18 years of age or older exclusion criteria: - diagnosed with any disorder that causes a compromised immune system (e.g. cancer such as leukemia, hiv/aids)
a phase 1a/1b study of elvn-001 for the treatment chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia; Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive; Cml

Summary: the purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of elvn-001 in patients with chronic myeloid leukemia with and without t315i mutations in patients who are relapsed, refractory or intolerant to tkis.

this first-in-human trial with elvn-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (rdes) of single agent elvn-001 in chronic phase cml with or without t315i mutations. the safety, tolerability and pharmacokinetic profile of elvn-001 will be assessed together with an evaluation of changes in bcr-abl1 transcript. an understanding of the safety profile, pk and preliminary evidence of anti-cml activity will be used to inform future development of elvn-001 in adults with cml. by virtue of its predicted pharmacological profile elvn-001 has the potential to be tolerable and achieve a deep molecular response in patients with cml with or without t315i mutations who do not tolerate or benefit from available tkis.

Eligibility criteria:
inclusion criteria: * bcr-abl1 positive cml in chronic phase, with or without t315i mutation. * the patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their cml. * ecog performance status of 0 to 2. * adequate hematologic, hepatic and renal function. * prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of elvn-001. exclusion criteria: * treatment with anti-cancer or anti-cml therapy within 7 days or 5 half-lives, whichever is longer. * history of acute tyrosine kinase inhibitor (tki)-related pancreatitis within 6 months of study entry. active chronic pancreatitis, or pancreatic disease due to any cause. * qtc \>470 ms.

Keywords: cml tyrosine kinase inhibitor t315i t315i mutant bcr-abl enable active site inhibitor of bcr-abl
natural history study of incidence of otorrhea following tympanostomy tube insertion in children 6 months to 12 years

Conditions: Otorrhea

Summary: this study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.


Eligibility criteria:
inclusion criteria: * participants must be at least 6 months old and no more than 13 years of age at the time of enrollment scheduled for unilateral or bilateral myringotomy and tympanostomy tube insertion. patients and/or child must read/sign informed consent and comply with requirement of the study. exclusion criteria: * there are no exclusion criteria.

Keywords: ear tubes ear drainage ear infection ear drops tympanostomy tubes pediatric patients
effect of head rotation on efficiency of face mask ventilation in anesthetized apneic adults

Conditions: Anesthesia

Summary: upper airway obstruction commonly occurs after induction of general anesthesia. the aim of this study is to determine if head rotation improves the efficiency of mask ventilation of anesthetized apneic adults.

when apnea is achieved after induction, face mask ventilation is started in either a neutral head position or a head position axially rotated 45 degrees to the right. mask ventilation will be carried out for 1 minute (step 1) with pressure control ventilation of an anesthesia machine at peak inspiratory pressure 15 cmh2o, 10 breaths per minute, inspiration time to expiration time ratio 1:2 and no positive end-expiratory pressure. then, mask ventilation will continue but head position will be crossed over (step 2) and step 1 will be repeated (step 3). expiratory tidal volume (vte) will be measured by using respiratory inductive plethysmograph.

Eligibility criteria:
inclusion criteria: * patients with body mass index in the range of 18.5 to 35.0 kg/m2, who meet american society of anesthesiologists physical status classification i to iii and require general anesthesia with tracheal intubation. exclusion criteria: * patients with limited head rotation/extension, gastro-esophageal reflux or a full stomach, known sleep apnea in continuous positive airway pressure therapy and any anticipated difficult airway likely requiring awake intubation.

Keywords: anesthesia induction airway mask ventilation
smartphone twelve-lead ecg utility in st-elevation myocardial infarction ii

Conditions: Myocardial Infarction; Ischemia; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Attack; Heart Failure

Summary: alivecor (www.alivecor.com) has developed several electrocardiogram (ecg) devices that interface with ios and android smartphones and tablets via various kardia apps. the current kardia family of devices can measure single lead and six limb-lead ecgs, depending on the device. kardiamobile, kardiamobile 6l, and kardiamobile card have fda clearance for ecg rhythm recording. a modified single-lead kardia smartphone 12-lead ecg was previously validated in the multicenter st leuis study for the diagnosis of st-segment elevation myocardial infarction (stemi) and non-st-elevation myocardial infarction (nstemi). recently, alivecor developed a new device: alivecor (ac) 12-lead (12l) ecg system to record simultaneously 4 leads of ecg and then generate complete 12-lead ecgs. a previous protocol at the university of oklahoma involved 200 subjects with early prototypes of the ac 12l device with the specific aim to validate that it accurately generated 12-lead ecgs as compared to simultaneously acquired fda-cleared 12-lead ecgs. the prototype version of the alivecor 12l ecg system simultaneously measured four channels of ecg (leads i, ii, v2, v4), calculated the remaining limb leads as is standard for 12-lead ecgs (leads iii, avr, avl, avf) and synthesized the remaining 4 precordial ecg leads (v1, v3, v5, v6). this protocol will serve to validate the production version of the system against standard 12-lead ecgs for the diagnosis of stemi and nstemi in patients admitted to the emergency department or directly to the cardiac cath lab for the evaluation of chest pain. it is anticipated that the waveforms for each of the 12 leads from the ac 12l ecg system will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ecg devices used at participating sites. the purpose of this study is to clinically validate that the four-channel ac 12l ecg device can enable the diagnosis of stemi and nstemi in a non-inferior manner to existing 12-lead ecg devices.


Eligibility criteria:
inclusion criteria: * male or female \> 18 years of age. * ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. * symptoms of chest pain upon presentation at the emergency department of the participating institution. exclusion criteria: * inability or refusal of the patient and/or the patient's legally acceptable representative to provide written informed consent for any reason. * other conditions that in the opinion of the lead investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
recovery after stress toolkit (reset) study

Conditions: Post-Traumatic Stress Disorder in Children; Post-Traumatic Stress Disorder in Adolescence

Summary: this study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (ptss) after receiving hospital based medical attention for an injury. half of the participants will received the online therapy and half of the participants will receive usual care.

as many as 30% of children develop post-traumatic stress symptoms after an injury. post-traumatic stress symptoms can decrease children's quality of life. psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. cognitive behavioral therapy and graduated exposures are standard treatments for ptss.

Eligibility criteria:
inclusion criteria: * 8 years to 17 years at enrollment * treated for an injury in the ed or hospitalized * abbreviated injury scale (ais) score 2 or greater * parent and child english speaking * broad band internet availability at home * residing with parent or legal guardian exclusion criteria: * moderate or severe traumatic brain injury (gcs less than 13) * diagnosed with moderate or severe intellectual disability * pre-existing psychiatric disorder that required hospitalization * abuse or interpersonal injury as mechanism of injury * currently receiving psychotherapy * hospitalized for injury over 30 ays * death of a family member or friend at time of injury