Kornimate/medical-research-clean huggingface dataset:
distal radius buckle fracture rct

Conditions: Distal Radius Fracture

Summary: this study evaluates the influence of cost information on decision-making for immobilization for treatment of distal radial buckle fractures. half of the participants will receive cost information from an orthopaedic surgeon prior to making their decision for treatment, while the other half will receive cost information from another member of the study team after they had made their decision treatment.

research has shown equipoise in treatment outcomes after casting and splinting for pediatric buckle fractures. despite the similarly favorable treatment outcomes associated with both casting and splinting these fractures, there is wide disparities in cost between the two types of immobilization. however, cost information is not routinely presented to families during the discussion of immobilization types. the primary objective of this study is to determine if cost information influences family decision-making about immobilization type after pediatric buckle fractures. a secondary objective is to determine if the timing of and person disseminating the cost information changes the influence it has on families' decision-making.

Eligibility criteria:
inclusion criteria: * males or females ages 4 to 14 years with a buckle fracture for which they will be treated with a cast or a splint. * parental/guardian permission (informed consent) and, if appropriate, child assent. * parent of a child ages 4 to 14 years with a buckle fracture that requires treatment with either a cast or a splint. * parental/guardian permission (informed consent). exclusion criteria: * non-english speaking subjects. * parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Keywords: distal radius fracture cost buckle fracture
effect of autologous peripheral blood stem cell treatment on articular cartilage regeneration

Conditions: Articular Cartilage Disorder of Knee

Summary: the purpose of this study was to compare histologic and mri evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (ha) with and without peripheral blood stem cells (pbsc)

the purpose of this study was to compare histologic and magnetic resonance imaging (mri) evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (ha) with and without peripheral blood stem cells (pbsc)

Eligibility criteria:
inclusion criteria: * patients who have signed informed consent form * patients with only unilateral isolated or multiple knee articular cartilage lesions demonstrated mri scanning, with up to one previous operation on that knee * patients who are either male or female aged between 18 to 50 years old, corresponding to availability of normative international knee documentation committee (ikdc) data. * female patients of childbearing age must have negative pregnancy tests and are advised to take contraceptive precautions throughout the study. exclusion criteria: * patients with bilateral knee lesions * patients with the presence of ligamentous injury which would require reconstruction, varus or valgus deformity greater than 10 degrees, previous open total menisectomy requiring osteotomy, and cases that require complex surgery prior to cartilage regeneration * patients with significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g. steroid intake, anticoagulation), and poorly controlled diabetes mellitus with a baseline hba1c more than 8 * patients with significant peripheral vascular disease as indicated by absent dorsalis pedis or posterior tibial pulses. * patients who cannot read english will be excluded from the study as they will be unable to complete the study questionnaires in an objective manner * female patients who are pregnant * patients with any contradictions to mri scanning * patients with body mass index (bmi) of over 35
effectiveness of 0.01% atropine sulfate solution in controlling of myopia progression in children

Conditions: Myopia

Summary: increasing number of myopic children and significant complications of high myopia enhance the necessity of effective control strategy. instillations of low-dose atropine have been shown to reduce myopia progression in asian populations but its effect in non-asian populations is still unclear. this open prospective study with historical control is designed to investigate if 0.01% atropine can reduce myopia progression in russian children, taking into account a change of difference between manifest and cycloplegic refraction, as well as, myopia progression rate at the time of recruitment.

the study is designed to test the following hypotheses: * 0.01% atropine one drop nightly is safe and with no significant side effects. * nightly instillations of 0.01% atropine does not influence tear production. * 0.01% atropine one drop nightly reduces the progression of childhood myopia in russian children. * nightly instillations of 0.01% atropine decreases the manifest refraction and, consequently, difference between manifest and cycloplegic refractions. * effectiveness of 0.01% atropine depends on the age and myopia progression rate at the time the therapy was started.

Eligibility criteria:
inclusion criteria: * myopia progression rate of 0.5d or more per year; * myopia with astigmatism of 1.0d or less; * axial length and cycloplegic refraction data obtained 6 months before recruiting or earlier * signed informed consent. exclusion criteria: * congenital myopia; * onset of myopia at 6 years old or earlier; * allergic reactions to any eye drops in anamnesis; * concomitant eye disorders, including strabismus.

Keywords: myopia low dose atropine progressive myopia atropine in non-asian population
zoledronate for osteopenia in pediatric crohn's

Conditions: Crohn's Disease; Osteopenia; Osteoporosis

Summary: background: * up to 30% of children and adolescents with crohn's disease have decreased bone strength, or decrease bone density, called osteopenia. * bisphosphonates are a group of drugs that have been well studied and found to be effective in the treatment of osteopenia in menopausal women. * zoledronate is a very potent third generation bisphosphonate, that is safe and easy to administer, and has been found effective in the treatment of menopausal women with osteopenia. hypothesis: the investigators hypothesize that zoledronate can improve bone density in children and adolescents with crohn's disease with osteopenia.

* this study is recruiting 40 children and adolescents, aged 6 to 18, who have a proven abnormal bone density as measured on a special type of x-ray called a dexa-scan. * participants are allocated at random to one of two groups: either treatment with zoledronate, or a placebo. * neither the participants or the physicians are aware of which group each participant is in. * participants are followed every three months for one year, and assessed with blood tests, urine tests, physical examination, diet questionnaire and exercise questionnaire. * participants have a repeat dexa scan at 6 and 12 months after beginning the study. * once all participants are enrolled and followed for one whole year, we will compare the bone density of the group treated with zoledronate with the group treated with placebo.

Eligibility criteria:
inclusion criteria: * patients aged 6 to 18, * diagnosed with crohn's disease with osteopenia, * a minimum of 6 months of adequate calcium and vitamin d intake. (osteopenia was defined for the purposes of this study as: z-score lumber spine bmd by dexa of -2.0 or less, or -1.5 and a risk factor (either steroid use for 6 months or more or decrease of 0.5 z-score in the preceding 12 months).) exclusion criteria: * renal dysfunction, * insufficient calcium or vitamin d intake, * current medication or condition affecting bone metabolism, * documented fracture, previously diagnosed bone disease, * documented intolerance/hypersensitivity to bisphosphonates, * previous treatment with bisphosphonates within the last 6 months.

Keywords: crohn's disease osteopenia osteoporosis bisphosphonates zoledronate
evaluating the effect of neighborhood environments on cardiovascular risk factors

Conditions: Cardiovascular Diseases

Summary: cardiovascular disease (cvd) is one of the main causes of death in the united states. research has shown that individuals who maintain an active lifestyle are less likely to develop cvd. this study will examine how neighborhood environments influence cvd risk factors of residents in and around the stapleton community of denver, colorado.

cvd is a major health problem in the united states. individuals who live in an environment in which it is difficult to maintain an active lifestyle may be more at risk for developing cvd. because of an increased interest in healthy living, urban planners and architects are now developing neighborhoods that are designed to encourage physical activity. parks, walking and bicycle trails, wider sidewalks, and community recreation facilities are examples of amenities that are being included in these neighborhoods. by incorporating these enhancements, the stapleton community in denver, colorado has been redeveloped as a more active living environment. the purpose of this study is to determine the effect of the neighborhood environment on the cardiovascular health of residents in five racially, ethnically, and socioeconomically diverse neighborhoods in or near the stapleton community. in years 1 and 2 of this study, 200 households from each of the five neighborhoods will be randomly chosen to complete a survey regarding their cardiovascular health, physical activity level, and use and perception of their neighborhood environment and facilities, for a total of 1,000 surveys. interviews and focus groups with members of the community will also be used to gather information. additionally, a neighborhood council composed of community members will be formed to study disparities among the five neighborhoods in their use of their neighborhood environments, their physical activity levels, and their cardiovascular risk factors. in year 2, study researchers will analyze the collected data and distribute the findings within the communities. they will also begin testing culturally and community relevant programs aimed at reducing cvd risk factors.

Eligibility criteria:
inclusion criteria: * live in one of the following five neighborhoods in the greater stapleton community: northeast park hill, greater park hill, east montclair, stapleton, or original aurora * speak either english or spanish

Keywords: health disparities built environments
microscopic fluorescence-guided vestibular schwannoma resection using fluorescein sodium and yellow 560

Conditions: Vestibular Schwannoma

Summary: the purpose of this study is to see if there is benefit to using an iv contrast called ak-fluor® and a microscope filter called yellow560 when surgically removing a vestibular schwannoma, meningioma, head and neck paraganglioma, or head and neck schwannoma.


Eligibility criteria:
inclusion criteria * patient with a suspected vs * recurrent vs with prior microsurgical resection or radiation therapy * clinical indication for microsurgical resection exclusion criteria * history of allergy to fs * history of renal failure * pregnant women * those with inability to give informed consent * prisoners and inmates

Keywords: head and neck paraganglioma head and neck schwannoma
assessment of a new apexification method for patients presenting a non vital immature tooth

Conditions: Dental Pulp Necrosis

Summary: pulp necrosis is one of the main complication of dental trauma. when it happens on an immature tooth, pulp necrosis implies a lack of root maturation and apical closure. a therapy called apexification is required to induce the formation of a calcified apical barrier allowing a permanent and hermetic root filling.the aim of this study is to compare the efficacy of a new apexification method using mineral trioxide aggregate (mta®) with the reference treatment based on calcium hydroxide repeated stimulations.

36 patients aged 6 to 18 and presenting a non vital immature tooth will be included in the study (inclusion period: 12 months). these patients will be randomly divided into two groups: one treated with mta®, and the other one with calcium hydroxide. for each patient, the total duration of the study will be 12 months. recalls will be performed at 15 and 21 days and then at 3, 6 and 12 months to assess by clinical and x-ray exams the main success criterion: presence of a calcified apical barrier or not. additional criterions such as presence of clinical symptoms or not, apical morphology and depth of this apical barrier will be observed. this randomised prospective therapeutic study will allow to assess the ability of mta® inducing apexification of a non vital immature tooth. furthermore, it will be possible to compare for both materials the kinetics of clinical symptoms disappearance and the morphology and depth of apices.

Eligibility criteria:
inclusion criteria: * indication of apexification treatment of an anterior immature tooth * patients aged 6 to 18 * enlightened agreement of the patient and his/her legal representatives * prerequisite medical examination exclusion criteria: general disease * diabetes * immunosuppression of whatever origin (aids, drugs, ...) * severe asthma * chronical disease requiring treatment * eating disorders (anorexia, bulimia, malnutrition, ...) oral disease * periodontal disease * administration of corticoids in a period of 3 months preceding the inclusion * patient with no social security cover

Keywords: apexification pulp necrosis calcium hydroxide mta pulp necrosis of an anterior immature tooth
standardized protocol of surgery and radiation for patients with brain metastases in relapsed neuroblastoma

Conditions: Relapsed Neuroblastoma

Summary: hitc001 is a single institution study to evaluate the efficacy of using a standardized protocol of surgery and radiation for patients with brain metastases in relapsed neuroblastoma.

this clinical trial aims to establish a standardized protocol consisting of surgery and radiation for patients with brain metastases in relapsed neuroblastoma. this will be an adjunct study to nmtrc009 onto which patients will be enrolled to for treatment with precision therapy. this study will follow the efficacy, safety, and cns progression-free survival of surgery and radiation.

Eligibility criteria:
inclusion criteria: * age: ≤ 21 years at the time of study entry. * diagnosis: histologic verification at either the time of original diagnosis or relapse of neuroblastoma. * disease status: patients must have one of the following along with disease in the cns: 1. any episode of recurrent disease following completion of aggressive multi-drug frontline therapy. 2. any episode of progressive disease during aggressive multi-drug frontline therapy. 3. primary resistant/refractory disease detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocols. * measurable or evaluable disease by brain mri. * current disease state must be one for which there is currently no known curative therapy. * meet all inclusion criteria for study nmtrc009 * informed consent: all subjects and/or legal guardians must sign informed written consent. assent, when appropriate, will be obtained according to institutional guidelines exclusion criteria: * meets all exclusion criteria for study nmtrc009 * subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.
dolutegravir expanded access study

Conditions: Infection, Human Immunodeficiency Virus; HIV Infections

Summary: ing114916 is an open-label, multi-center, expanded access (eap) study

ing114916 is an open-label, multi-center eap to allow access to patients with hiv-1 infection who have documented raltegravir or elvitegravir resistance, have limited treatment options and require dolutegravir to construct a viable anti-retroviral regimen for therapy. patients must not be eligible for another ongoing dolutegravir clinical trial in order to participate in this eap. the duration of patient accrual into the study will extend until dolutegravir receives local (by country) regulatory approval.

Eligibility criteria:
inclusion criteria: 1. adult subjects greater than 18 years of age 2. documented hiv-1 rna \>/= 400 c/ml 3. documented raltegravir or elvitegravir resistance 4. inability to construct a viable background art regimen with commercially available medications. - exclusion criteria: 1. creatnine clearance \< 30ml/min via cockcroft-gault method 2. females who are pregnant and/or breastfeeding 3. patients with known integrase allergic reaction 4. alt \> 5 times the uln within one month of treatment initiation 5. alt \> 3 times uln and total bilirubin \>1.5 times uln 6. evidence of severe hepatic impairment 7. patients eligible for, and have access to, an actively enrolling dtg phase iii clinical study 8. any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications -

Keywords: treatment experienced patients integrase resistance
patient satisfaction and oral health-related quality of life of quadrilateral versus bilateral linear bar designs for four implant implant-assisted complete mandibular overdenture regarding peri-implant crestal bone loss

Conditions: Edentulism

Summary: for this study, twenty patients were selected, and participants were randomly divided into two groups using random numbers produced in an excel spreadsheet. each patient got four implants in the mandibular canine and first molar sites, as well as the bar attachment. the purpose of this study was to document and report patient satisfaction with mandibular implant overdentures with quadrilateral distribution and linear distribution. the null hypothesis was that patient satisfaction would not be different depending on the distribution type (quadrilateral or linear). according to the bar design, all patients were classified into two equal groups: quadrilateral bar design (group i) and bilateral linear bar design (group ii). peri-implant marginal bone loss was evaluated immediately (t0) and after 2 years (t2) of overdenture insertion using a digital periapical x-ray.


Eligibility criteria:
inclusion criteria: * have angle's class i maxilla-mandibular relation * sufficient inter-arch space * a healthy, firm mucosa, * enough residual alveolar ridges in the mandibular regions to support implants exclusion criteria: * neuromuscular disorder, * excessive smoking, * alcoholism, * parafunctional habits * systemic disorders affecting the bones * history of head and neck radiation therapy.
dose-escalation, single dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of gb-6002 local infiltration in healthy male adults

Conditions: Pain, Postoperative

Summary: this study is to evaluate the safety and tolerability of single dose of gb-6002 (ropivacaine) local infiltration in healthy male adults. and, it is to compare pharmacokinetic characteristics of gb-6002 single dose injection with active comparator.


Eligibility criteria:
inclusion criteria: * healthy adult males,19 to 55 years of age, inclusive at the time of screening visit. * at the time of screening, those with a body weight of 55 kg or more and a bmi (body mass index) within 18.0 to 27.0 kg/m², inclusive. * subjects who do not have plans to receive covid-19(coronavirus disease 2019) vaccination during the clinical trial starting from 14 days prior to the first administration of investigational drug. * subjects who have understood the purpose of this clinical trial, voluntarily chosen to participate, and provided written consent to adhere to the restrictions. exclusion criteria: * subjects with clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematologic, oncological, psychiatric, or urological conditions, or a history related to such conditions. * subjects with systolic blood pressure less than 90 mmhg or greater than 150 mmhg, or diastolic blood pressure less than 50 mmhg or greater than 100 mmhg during the screening assessments. * subjects who exhibited clinically significant abnormalities in physical examination, clinical laboratory tests, or electrocardiograms during the screening assessments. * subjects known to be hypersensitive to investigational product and its components. * subjects who have continued to drink alcohol within 1 month prior to the first administration of investigational product or who are unable to abstain from alcohol during the clinical trial. * subjects who smoked continuously within 1 month prior to the first administration of investigational product or are unable to quit smoking during the clinical trial. * subjects who has taken drugs that induce or inhibit drug metabolism enzymes, such as barbiturates, within 1 month prior to the first administration of investigational product.
treatment of chronic low back pain: a trial comparing traditional back school and individual therapist-assisted exercise

Conditions: Chronic Low Back Pain

Summary: rheumatologists are discussing, whether rehabilitation of patients with low back pain (lbp) can be improved. at present patients with lbp start treatment as soon as possible, this also applies for patients with chronic low back pain (clbp) - pain lasting over 12 weeks. at glostrup university hospital department of physical medicine/rheumatology we use a method (method a) where an interdisciplinary team gives the patients a treatment composed of various topics. this includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. a different method (method b) originates from the rehabilitation centre in karlslunde led by teddy oefeldt. here they focus strictly on dynamic training of muscles in the back and the buttocks. a therapist, who in the beginning partly carries the patient through the exercises, assists this training. in both methods, individually considerations are taken, but to a greater extend in method b. the treatment will extend over a three months period. a few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months. 286 consecutive patients were included and randomized to one of the two methods. those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (method a)


Eligibility criteria:
inclusion criteria: 1. low back pain lasting more than 12 weeks with or with out pain radiating into the leg(s) 2. age 18 - 60 years exclusion criteria: 1. serious spinal pathology 1. malignancy 2. osteoporosis, 3. fresh vertebral fracture 4. newly operation on the back 5. stenosis of the lumbar spine 6. unstable spondylolistesis 7. infections in the back 2. neurological dysfunction of the thoracic or abdominal muscles 3. pregnancy/breastfeeding 4. mental illness 5. health conditions which prohibit intensive training. 6. languish problems/ dyslexia

Keywords: low back pain dynamic back-muscle exercise treatment interdisciplinary treatment roland morris disability questionnaire sf-36 low back pain rating scale