Kornimate/medical-research-clean huggingface dataset:
infra-orbital nerve block for post operative analgesia in children undergoing cleft lip surgery.

Conditions: Postoperative Pain

Summary: this study will be undertaken to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.

oro-facial clefts are the most prevalent craniofacial birth defects and the second most common birth anomaly, second only to clubfoot \[strong \& buckmiller 2001\]. cleft lip surgery is associated with appreciable postoperative pain in children alleviation of postoperative pain is important in these patients. the fear of respiratory depression using opioids has renewed the interest in regional anesthesia to provide safe and effective postoperative analgesia. infra-orbital nerve block has been advocated as a suitable local analgesic technique for cleft lip surgery and superficial surgery on the mid face \[morton 2004, takmaz et al. 2009, rajesh et al. 2011, jindal et al. 2011\].the infra-orbital nerve supplies the upper lip, lower eyelid, and adjacent skin of the cheek and nose. unilateral or bilateral infra-orbital nerve block has been performed with a very high success rate. the investigators designed this study to evaluate the safety and analgesic efficacy of adding ketamine to bupivacaine in bilateral infra-orbital nerve block for relief of pain postoperatively following repair of cleft lip in children less than two years of age.

Eligibility criteria:
inclusion criteria: (asa) physical status i and ii aged less than 2 years undergoing elective cleft lip repair (with or without cleft palate) under general anesthesia. exclusion criteria: patients with local infection at the site of injection of block, history suggestive of drug allergy, any systemic disease that compromises the cardiovascular, respiratory or neurological function, other congenital anomaly, history of upper or lower airway disease, coagulation disorders, and children with history of sleep apnea and in whom postoperative ventilation may be required will be excluded from the study.
actigraphic analysis of treatment response

Conditions: Sleep Disorders, Circadian Rhythm; Insomnia; Psychomotor Agitation

Summary: the study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.

actigraphic measurements will be recorded every 30 seconds and will be recorded for an 11 day baseline period, followed by a 10 day period of the initial pharmacological interventions. the non-invasive nature of watch-like actigraphy devices is particularly attractive for use in pediatric populations. meaningful treatment response measurements are obtained when actigraphic data is combined with psychometric and observational repeated measurements. subsequent to the initial data collection the parent consented and the child assented to extend the study and continue measurements. the case study included baseline and repeated psychological, observational and actigraphic measurements that were initiated prior to treatment with risperidone and repeated throughout the treatment process with the final data collected in july 2010. the personality inventory for children (pic) is an objective multidimensional measurement of affect, behavior, ability and family function. the pic was administered prior to treatment with risperidone and repeated after 22 months of treatment. the pic serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment associated change. a primary observer (mother) was trained to report symptom percentages present since previous observations utilizing the operationally defined and observer defined items of the systematic observation scale throughout the treatment process. actigraphic measurements provide a basis by which to measure sleep and sleep onset latency as well as periods of mobility and immobility. when programmed to record activity every thirty seconds, thousands of measurements are quickly captured. actigraphic measurements were made utilizing a watch-like actigraphic device with an 11 day baseline actigraphic measurement period and continued measurements that included the initiation of a once-daily, bedtime (q.h.s.) pharmacological intervention for 6 days, followed by a planned adjustment to twice a day (b.i.d.) dosing that was measured for an additional 4 days. repeated actigraphic studies were subsequently conducted after 22 months of risperidone treatment and were collected along with the repeated observational and psychometric data. this case study explores activity and sleep characteristics related to behavioral characteristics and treatment response and the utility of single subject repeated actigraphic, psychometric and observational measurements and monitoring of treatment response.

Eligibility criteria:
inclusion criteria: * diagnosis of kabuki syndrome * medication naive * single subject preparing to receive pharmacological intervention exclusion criteria: * inability to wear actigraphy device

Keywords: kabuki syndrome actigraphy treatment response measurement
oral hymecromone to treat adolescents and adults with primary sclerosing cholangitis.

Conditions: Primary Sclerosing Cholangitis

Summary: primary objective: to evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (psc). secondary objectives: to evaluate the change in alkaline phosphatase (alp) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care. to evaluate changes in biomarkers of psc disease during hymecromone treatment, namely: (a) fibrotic effect (fibroscan); (b) inflammatory biomarkers (serum hyaluronan (ha)); and, (c) t-cell count.


Eligibility criteria:
inclusion criteria: * diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study * if history of endoscopically confirmed inflammatory bowel disease, currently stable based on mayo score / disease activity index (dai) for ulcerative colitis score ≤ 1, normal inflammatory markers (esr, crp and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months exclusion criteria: * currently receiving biologic therapies * known allergy to hymecromone * cholangiocarcinoma * pregnancy * serious liver disease
changes in reliability when assessing multiple patient-reported outcome measures

Conditions: PROM

Summary: this study investigates how reliability of patient reported outcomes can be affected with questionnaire burden and and the number of questionnaires given to study participants.

the primary objective of the study is to determine if the number of remotely administered questionnaires completed by fracture patients affects the psychometric properties of a questionnaire itself. we will assess the internal consistency of the euroquol five dimension - five level (eq-5d-5l) health survey questionnaire as more questionnaires are applied. the secondary objective is to evaluate how the number of questionnaires and the time it takes to complete them impact patient's preferences and values. we will measure the time taken by each participant to complete the eq-5d-5l questionnaire to evaluate if it changes meaningfully as the number of questionnaires given to participants' increases. additionally, we will assess patient preferences and values by asking how well the remotely collected proms reflect their health status, and how this changes relative to the number of questionnaires administered. our hypothesis is that there is a progressive decline in psychometric properties in the eq-5d-5l, both in reliability and validity, as we increase the number of questionnaires given to participants. we also hypothesize that the time to complete the ed-5d-5l will increase as the number of questionnaires given to participants' increases, and that there is a threshold at which the patient feels there are no additional value to completing additional remote proms to adequately reflect their health status.

Eligibility criteria:
inclusion criteria: 1. the patient presents to the in-person or virtual fracture clinic for his/her own appointment. 2. the patient has a fracture that is being managed either operatively or non-operatively. 3. fracture occurred in the past 6 months. 4. the patient is 18 years of age or older. 5. the patient is able to read, understand, and write in english. 6. patient provides informed, verbal or written consent. exclusion criteria: 1. the patient is considered too ill or injured to participate in the study. 2. the patient is cognitively impaired, intoxicated or otherwise unable to provide consent or participate in the study. 3. the patient is co-enrolled in another study requiring completion of multiple additional proms.

Keywords: consistency reliability burden response methodology
chronic lymphoid leukaemia observatory in finistere area, france

Conditions: Chronic Lymphoid Leukaemia

Summary: brief summary: the purpose of the ofice registry is to characterize and describe the cll patients' population from the finistere area and evaluates the association between different patient characteristics, prognosis and treatment patterns. detailed description: ofice is a single center, prospective, observational registry of cll patients designed to provide a general description of the cll patients' population from the finistere area, france. the registry will also provide information on the association of cytogenetic and immunophenotypic characteristics with disease progression, as well as treatment patterns and healthcare resource utilization. these data will be accessible and beneficial for researchers and physicians and will help guide clinical practice and future clinical or fundamental studies.


Eligibility criteria:
inclusion criteria: * age of at least 18 years * clinical diagnosis of cll/sll that meets published diagnostic criteria (hallek 2008) * willing and able to provide informed consent * willing and able to provide blood sample at time of enrollment exclusion criteria: * diagnosis of other b-cell malignancies

Keywords: chronic lymphocytic leukemia observational study
symptom based treatment of neuropathic pain

Conditions: Neuralgia; Spinal Cord Injury

Summary: 1. neuropathic pain in spinal cord injured patients 1. inclusion criteria * pain intensity, visual analogue scale \> 3 * a lanss (leeds assessment of neuropathic symptoms and signs) score of 12 and above * aged ≥20 2. method * stop pain medications * test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily) * check pain intensity (vas score) with baron's classification

in the present study, pharmacologic treatment included pregabalin and oxcarbazepine. stop medications such as non-steroidal anti-inflammatory drugs (nsaids), tramadol and anti-spastic drugs (baclofen, tizanidine) and other medications known to have effect on pain and the central nervous system prior to the study for at least 3 days. 1. pain intensity (vas score) 1. 4 spontaneous characters * electric * burning * pricking * numbness 2. evoked pain * allodynia * heat hyperalgesia * pressure hyperalgesia 2. location of neuropathic pain 1. neuropathic pain at level of spinal cord injury 2. neuropathic pain below level of spinal cord injury 2. side effects

Eligibility criteria:
inclusion criteria: * aged than 20 years * neuropathic pain symptoms : lanss (leeds assessment of neuropathic symptoms and signs) score of 12 and above * visual analogue scale score of 3 and above exclusion criteria: * no pregnancy * systemic disease * psychiatric disease

Keywords: neuralgia spinal cord oxcarbazepine pregabalin drug therapy algorithms
effectiveness of creatine supplementation and exercise on muscle and bone

Conditions: Osteoporosis; Sarcopenia

Summary: as we age, we experience a reduction in muscle and bone which inevitably decreases strength and the ability to perform tasks of daily living such as gardening, carrying groceries, and climbing stairs. health costs associated with aging muscle and bone loss are in the billions of dollars. with the projected increase in life expectancy, the incidence of muscle and bone loss will rise and further drain the healthcare system, with greater need for hospitalization, treatment, and rehabilitation. without effective strategies to counteract aging muscle and bone loss, we may face a healthcare crisis in the future. creatine, a compound found in red meat and seafood, increases creatine phosphate stores in muscle, providing increased energy during high-intensity exercise. short-term (i.e. 3-4 months) resistance-exercise and supplementation with creatine, have been shown to have a favorable effect on properties of aging muscle and bone. however, the longer-term (i.e. 1 year) effects of these interventions are unknown. therefore, the purpose of this innovative research is to determine the longer-term effects of resistance-exercise and creatine supplementation (0.1g•kg-1) in older adults. the primary dependent variables to be assessed will include muscle hypertrophy, bone mineral and bone geometry, strength, and urinary and blood indicators of liver and kidney function. this innovative, multidisciplinary research will help contribute to the successful pursuit of prolonged independent living by improving aging musculoskeletal health for older saskatchewan adults. saskatchewan provides a relevant setting for this research, given the higher percentage of older adults (15%), compared to the national average (12%). we hypothesize that creatine supplementation will increase muscle mass, strength, and bone mineral density more than placebo.


Eligibility criteria:
inclusion criteria: * greater than or equal to 50 years of age * males or postmenopausal females * not currently participating in resistance training exclusion criteria: * pre-existing kidney abnormalities * previous fragility fractures * history of taking medications that affect bone mineral density in the past year including bisphosphonates, parathyroid hormone, calcitonin, hormone replacement therapy, or corticosteroids (i.e. within the past year) * suffer from severe osteoarthritis * have taken creatine supplementation within the past 6 months

Keywords: bone muscle strength kidney liver creatine
individualized treatment based on epidermal growth factor receptor mutations and level of brca1 expression in advanced adenocarcinoma

Conditions: Non-small Cell Lung Cancer

Summary: this is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.

pharmacogenomic study, prospective, multicenter. individualized treatment based on egfr mutations and level of brca1 expression in patients with advanced lung adenocarcinoma

Eligibility criteria:
inclusion criteria: * patients age 18 years or more. * histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and bac histology). * only patients with advanced disease, defined as stage iv or iiib with/without pleural effusion, will be included. * tumor sample available. * a measurable lesion, as defined by recist criteria. * karnofsky score 60% or more (ecog \< 2). * patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment. * patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment. * patients with hepatical, renal and hematology normality values. * patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood. * patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study. * patients must be available for clinical follow-up.. exclusion criteria: * patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiegfr receptor agent. * severe comorbidity.

Keywords: nsclc
reliability of the angle measurement of the software for photogrammetry postural assessment (sapo)

Conditions: Body Posture Alignment Condition; Temporomandibular Disorder

Summary: the present study aims to verify the reliability of intra and inter-examiner of angular measures proposed by sapo postural assessment software. methods: 24 subjects were photographed and three experienced examiners analyzed the images.

the body posture in the orthostatic position has been widely utilized as in the clinical practice as in the research, for the diagnosis and physiotherapy treatment planning. the photogrammetry has been used as a valuable resource for the physiotherapist's diagnosis and verification of measuring postural changes, but the lack of standardization of anatomic references, the used angles between them and their meaning embarrasses comparison among studies.

Eligibility criteria:
inclusion criteria: * 20-35 years old * diagnosis of temporomandibular disorder exclusion criteria: * neurological diseases * systemic diseases * lower limbs fracture * balance disorder

Keywords: reliability photogrammetry
myocardial injury after bnt162b2 mrna covid-19 fourth dose vaccination among israeli health care workers

Conditions: Myocardial Injury; Vaccine Adverse Reaction; COVID-19

Summary: the aim of the study is to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose bnt162b2 mrna vaccine (pfizer-biontech) against covid-19.

population-based retrospective studies suggest an association between bnt162b2 (pfizer-biontech) vaccination against coronavirus disease 2019 (covid-19) and myocarditis. while the overall incidence of myocarditis is estimated to be 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher. adult health care workers who received the bnt162b2 vaccine in two israeli hospitals (szmc and shamir) during the fourth dose campaign had blood samples taken for high-sensitivity cardiac troponin (hs-ctn) measurement at the time of vaccine administration and after 2-4 days. post-vaccine myocardial injury was defined as hs-ctn elevation above the 99th percentile upper reference limit and \>50% increase from the first measurement. participants with evidence of myocardial injury underwent assessment for possible myocarditis including electrocardiogram and echocardiography.

Eligibility criteria:
inclusion criteria: * adult health care workers (≥18 years old) exclusion criteria: * acute coronary syndrome, peri/myocarditis, cardiac catheterization, cardiac surgery, cardiac ablation, or any other invasive cardiac procedure within 14 days prior to study enrollment. * chronic renal failure (creatinine clearance ≤30 ml/min), or dilated or hypertrophic cardiomyopathy

Keywords: myocardial injury vaccine covid-19
acceptance and efficacy of live supervision

Conditions: Mental Disorders

Summary: in order to meet an existing lack of empirical studies in the field of cognitive behavioral therapy supervision, the present randomized controlled trial is aimed at comparing two different types of supervision. this study compares computer-assisted live supervision and delayed video-based supervision regarding efficacy and acceptance among therapists, patients and supervisors. the efficacy of supervision is defined on different levels such as change of psychotherapeutic competence, nondisclosure, self-efficacy, self-awareness of the supervisee as well as therapeutic alliance, supervisory alliance and therapy outcome.


Eligibility criteria:
supervisees inclusion criteria: * having successfully completed the interim audit * having started to treat ambulant patients under supervision exclusion criteria: - patients inclusion criteria: * meeting icd 10 criteria for a mental disorder * informed consent exclusion criteria: * currently in psychotherapy * suicidal tendency * clinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder

Keywords: computer-assisted live supervision "bug-in-the-eye" supervision delayed video-based supervision cognitive behavioral therapy supervision
an observational study of the safety of herceptin given subcutaneously in patients with early her2-positive breast cancer

Conditions: Breast Cancer

Summary: this non-interventional prospective study will assess the safety of herceptin sc (subcutaneous administration) as used in routine clinical practice. patients with her2-positive early breast cancer, naive and non-naive of her2+ treatment who are to be treated in the neoadjuvant and adjuvant setting and scheduled to initiate a treatment with herceptin sc in routine clinical practice use are eligible to participate. the total study duration is anticipated to be 38 months.


Eligibility criteria:
inclusion criteria: * aged \>/= 18 years * patients with her2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant her2+ treatment * patients for whom the investigator has decided to start a treatment with herceptin sc * trastuzumab treatment naive or non-naive (previously intravenous treatment) * informed consent exclusion criteria: * patients previously treated with herceptin sc treatment
tripterygium wilfordii hook f and methotrexate for postmenopausal women with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study is a multicenter, randomized, double-blinded, controlled trial with two parallel arms. the aim of the study is to evaluate whether tripterygium wilfordii hook f combined with methotrexate (mtx) might be better than mtx alone for postmenopausal women with active rheumatoid arthritis (ra).

to compare the efficacy and safety of tripterygium wilfordii hook f (twhf) and methotrexate (mtx) for postmenopausal women with active rheumatoid arthritis (ra), a multicenter, randomized controlled trial will be conducted. three hundred postmenopausal women with active ra will be randomly allocated (1:1) to treatment with twhf 20mg thrice daily and mtx 10 mg once a week for 24 weeks, or mtx plus dummy twhf. the primary outcome is the percentage of participants with american college of rheumatology 20% at week 24.

Eligibility criteria:
inclusion criteria: 1. postmenopausal women, postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels \> 40 miu/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy; 2. diagnosed with ra as determined by meeting the 2010 acr/eular classification criteria and having had ra for at least 6 weeks; 3. active disease at the time of enrollment as indicated by 28-joint disease activity score (das28) greater than 3.2; 4. no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents. exclusion criteria: 1. ra combined with other autoimmune disease, such as adjuvant arthritis, lupus arthritis, or osteoarthritis; 2. ra combined with abnormal liver and kidney function; 3. severe chronic or acute disease interfering with attendance for therapy; 4. patients who had received dmards or biological therapy within one months before participating in this study.

Keywords: rheumatoid arthritis tripterygium wilfordii hook f methotrexate postmenopausal women randomized controlled trial