Kornimate/medical-research-clean huggingface dataset:
calcitriol and dexamethasone in patients with myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: this is a study to determine the response rate in patients with myelodysplastic syndromes treated with calcitriol and dexamethasone.

current therapeutic options for myelodysplastic syndromes (mds) are limited and, aside from bone marrow transplantation, none have proven superior to supportive measures alone. preclinical investigations have indicated the potential therapeutic role for vitamin d in the treatment of mds. however, because of the dose-limiting toxicity of hypercalcemia, past clinical trials with vitamin d have been forced to utilize low doses, with promising but inconsistent results. this study utilizes a dosing schema of dexamethasone (dex) and calcitriol (the active form of vitamin d) that augments the therapeutic index of calcitriol, and allows for safe administration of 5-10 times higher dose of calcitriol than previously has been used in clinical trials for mds. patients will receive dexamethasone 4 times per week and calcitriol 3 times per week. this schedule will continue weekly until patients are off study. the dose of calcitriol will be increased until the maximum tolerated dose (mtd) is determined. history and physical examination, blood monitoring, urinary ultrasounds, and bone marrow aspirations and biopsies will be used to assess disease response.

Eligibility criteria:
inclusion criteria: * histologically confirmed refractory anemia (ra), ra with excess blasts (raeb), raeb in transformation (raeb-it), or ringed sideroblasts (rars) * evidence of cytopenia affecting at least 1 hematological cell lineage * adequate liver and renal function * ecog 0-2 * expected survival of at least 12 weeks exclusion criteria: * symptomatic coronary artery disease * uncontrolled diabetes mellitus * uncontrolled and symptomatic glaucoma * history of dangerous reactions to steroid therapy * chemotherapy or any hematopoietic growth factor therapy within the past 8 weeks * history of nephrolithiasis * children * chronic myelomonocytic leukemia (cmml)

Keywords: hematopoiesis apoptosis cell differentiation bone marrow cells
assessing fever rates in children ages 24 to 59 months after live attenuated influenza vaccine (laiv) or inactivated influenza vaccines (iiv) using text messaging for u.s. influenza vaccines in 2012-2013 & 2013-2014

Conditions: Fever

Summary: in this study, the investigators will prospectively assess fever rates in 24-59 month old patients during days 0-10 after administration of inactivated influenza vaccine (iiv) or live attenuated influenza vaccine (laiv). children in one of three study sites who receive these vaccines as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. children enrolled in this study will be observed for an eleven day period starting on the day of vaccine administration via a series text messages to their parents.


Eligibility criteria:
inclusion criteria: 1. are 24 through 59 months of age, 2. have a visit at a study site anytime during the study period, 3. receive first dose laiv or iiv in the season, 4. the parent has a cell phone with text messaging capabilities, and 5. the parent speaks english or spanish. exclusion criteria: 1. any chronic medical condition in the child that precludes receipt of laiv (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record), 2. currently on oral or other systemic steroids or used in the past month, 3. currently on inhaled steroids or used in the past 2 weeks, 4. presence of fever \>=100.4 at time of vaccination, 5. administration of any antipyretic in the 6-hour period prior to vaccination, 6. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever, 7. parent only speaks a language other than english or spanish, 8. parent's inability to read text messages, 9. child receiving the second dose of influenza vaccine in the current season.
universal vs. targeted school screening for adolescent major depressive disorder

Conditions: Major Depressive Disorder; Major Depressive Episode

Summary: the primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.

the prevalence of annual major depressive disorder (mdd) episodes has increased by greater than 50% from 2008 to 2015 among us adolescents. paralleling the rise in mdd, suicide is now the 2nd leading cause of adolescent deaths. despite the us preventive services task force (uspstf) 2009 endorsement of universal screening for adolescent mdd in primary care, mdd screening occurs in less than 2% of office visits. the primary goal of the proposed study is to compare the effectiveness of universal versus targeted adolescent mdd screening in a school setting. universal screening was chosen to be conducted in schools because, compared to medical settings; schools are more likely to regularly engage with adolescents. the hypothesis is that universal school-based screening with the validated patient health questionnaire (phq) will result in increased rates of mdd screening, identification and treatment engagement. the penn state team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, psychiatry and engagement with minority populations.

Eligibility criteria:
inclusion criteria: * students in grades 9-12 at 14 public schools in pennsylvania. this is a change from the originally anticipated 16 schools, as 2 were unable to continue participation. anticipated enrollment numbers will be updated once the data are finalized. hrsa funding for primarily rural school districts (only one is urban). pcori funding for urban school districts. exclusion criteria: * students whose parents complete the opt-out consent * students not enrolled in one of the participating schools * students not in grades 9-12 * students with disabilities that are deemed unable to participate by the school district

Keywords: adolescent; mental health; depression; suicide
vanguard complete knee versus vanguard high flex rotating platform (rp) knee study

Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis

Summary: the purpose of this study is to compare vanguard high flex rotating platform to vanguard complete knee system in asian population in terms of early range of motion (rom), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.

the primary objectives of this clinical study include: * evaluate size fit and long term performance of vanguard complete knee ("fixed") system in asian and latino population in comparison to competitor's similar product. * evaluate efficacy of vanguard complete knee with microplasty tibial tray. * compare vanguard high flex rotating platform ("high flex") knee system to vanguard complete knee system in asian population in terms of: * early rom * clinical outcomes * kinetic and kinematic characteristics in relation to healthy knees. o * compare current design to new design of vanguard high flex rotating platform knee system in terms of : * early rom * clinical outcomes * kinetic and kinematic characteristics

Eligibility criteria:
inclusion criteria: * painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. * correction of varus, valgus, or posttraumatic deformity. * correction or revision of unsuccessful osteotomy, or arthrodesis. * need to obtain pain relief and improve function. * ability and willingness of the patient to follow instructions, including control of weight and activity level. * good nutritional state of the patient. * patient must have reached full skeletal maturity. exclusion criteria: * infection, sepsis, osteomyelitis, and failure of previous joint replacement. * uncooperative patient or patients with neurologic disorders who are incapable of following directions. * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, neuromuscular disease * incomplete or deficient soft tissue surrounding the knee
german multicenter trial for treatment of newly diagnosed acute lymphoblastic leukemia in adults (05/93)

Conditions: Adult Acute Lymphocytic Leukemia

Summary: the study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. it includes a distinct protocol for the subgroup 'mature b-all',


Eligibility criteria:
inclusion criteria: * acute lymphocytic leukemia * age 15 - 65 years exclusion criteria: * serious secondary diseases which may compromise intensified chemotherapeutical treatment * serious psychiatric diseases, which may compromise compliance with therapy * hiv-1 or hiv-2 infection * pretreatment \> 2 weeks or chemotherapy other than vincristine and steroids * patients without central diagnosis who cannot be allocated to a risk group

Keywords: all treatment de novo adult
staphylococcus aureus caught in action at the site of infection

Conditions: Staphylococcus (S.) Aureus Infection

Summary: this study is to obtain a comprehensive view of s. aureus adaptations in the infected human host and (i) to improve the understanding of the interface between antibiotic therapy, resistance development and virulence factor adaptation in s. aureus infected patients, and (ii) to adapt these findings into a more sustainable use of antimicrobials for therapy.

staphylococcus (s.) aureus is notorious for its ability to develop resistance. this study is to obtain a comprehensive view of s. aureus adaptations in the infected human host and (i) to improve the understanding of the interface between antibiotic therapy, resistance development and virulence factor adaptation in s. aureus infected patients, and (ii) to adapt these findings into a more sustainable use of antimicrobials for therapy. patients with s. aureus infections who will routinely undergo diagnostic and surgical procedures will be identified. intraoperative samples from the site of infection during surgery will be taken. additionally, two blood drawing events (22.5ml in total) will be performed and nose swabs will be taken. the biological material will be analysed. this project will be the first to study different phenotypes of invasive s. aureus directly from its environment in vivo.

Eligibility criteria:
inclusion criteria for patients: * in collaboration with the orthopedic surgeons, patients with probable or proven s. aureus infections will be identified who will routinely undergo diagnostic and surgical procedures: inclusion criteria for healthy participants: * healthy control group should be generally well-being exclusion criteria for patients and for healthy participants: * pregnancy: pregnant or lactating women will be excluded (urinary pregnancy test will be performed in women of childbearing age) * general health condition: current or recurrent disease that could cause complications that may affect the study or may set the patient at risk * diseases/ illness: psychiatric or other mental disorders which in the opinion of the investigator may probably affect the full understanding of the study (including signs of dementia) * language: insufficient knowledge of german language to understand the procedure and rationale of the research question * vulnerability: individuals whose willingness to volunteer in the research project may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, such as members of a group with a direct hierarchical structure (refer to ich guidelines e6 (r1) for gcp, 1.61)

Keywords: antibiotic therapy virulence factor adaptations resistance development genomic alterations of s. aureus
effects and mechanism of the fully immersive virtual reality cognitive training based on leisure activities

Conditions: MCI; SCD

Summary: the aim of this study is to identify the effects of the immersive leisure-based vr cognitive training, and compare the intervention effects for elderly with mci and scd. the investigators anticipate the vr training can facilitate cognitive function, daily function, quality of life. the investigators anticipated the metabolic biomarkers, mechanism, and brain activities will be found. the significance of this study is identifying the effect of immersive leisure-based vr cognitive training, and confirming the metabolic biomarkers and brain activities. it could improve the accuracy of identification, prevent the progression to dementia, and lead the field of technological assistance to new opportunities for training.


Eligibility criteria:
inclusion criteria: - mci inclusion criteria: age\>=60 able to follow instruction moca\<26 scores on cognitive tests for individuals with mci are 1 to 1.5 standard deviations below the mean for their age and education matched peers on culturally scd inclusion criteria: age\>=60 ecog-12 score \>1 moca\>=26; does not conform the standards of mci and dementia exclusion criteria: - dizziness or epilepsy history; neurological or other orthopedic diseases with neurological or other orthopedic diseases unstable physical condition of vr cognitive training recent psychiatric diagnosis, such as depression

Keywords: mild cognitive impairment subjective cognitive decline combination therapy virtual reality cognitive training leisure activities
association between ankle dorsiflexion and frontal projection angle in pfps

Conditions: Patellofemoral Pain Syndrome

Summary: the study will investigate an association between ankle dorsiflexion and altered frontal knee kinematics during step down test in patients with pfps.

altered frontal and transverse plane hip kinematics during single leg weight-bearing tasks are thought to be important contributors to patellofemoral pain (pfp). the closed chain nature of single leg tasks means that hip kinematics can be influenced by more distal mechanics, such as foot pronation. one of the often-studied distal movements theorized to cause pfps is pronation of the subtalar joint. pronation is a tri-planar movement that includes dorsiflexion, eversion, and abduction of the foot. many studies have examined eversion characteristics of pfps patients, but the dorsiflexion aspect of the movement has been shown to be a possible risk factor, restricting dorsiflexion was shown to increase medial knee displacement in young healthy adults. conversely, when available dorsiflexion rom is increased, medial knee displacement is thought to decrease. patients with pfps were observed to have a decreased dfrom (dorsiflexion range of motion) as compared to normal individuals, though this topic has not thoroughly been investigated.

Eligibility criteria:
inclusion criteria: 1. anterior or retropatellar knee pain from at least 2 of the following activities : (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping. 2. insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6weeks. 3. vas equal to or greater than 3. 4. age of the subject 18-35 years to limit the possibility that pfps over age 35 may have been complicated by arthritic changes, and also the subjects should have closed epiphyseal growth plates. 5. bmi under 30 kg/m2, both gender for the control group, subjects were recruited to this study if they had: 1. no previous history or diagnosis of knee pathology. 2. no pain with any of the above-mentioned provocative activities. 3. no history of lower limb or spinal pathology. exclusion criteria: 1. a history of any of the following condition: meniscal or other intraarticular pathologic conditions; cruciate or collateral ligament involvement. 2. a history of traumatic patellar subluxation or dislocation. 3. previous surgery in the lower extremities within the 12 months prior to participation in the study. 4. any balance impairments are secondary to a vestibular or neurological disorder or secondary to the use of medication. 5. any lower limb bony/congenital deformity

Keywords: patellofemoral pain syndrome knee kinematics frontal projection angle ankle motion
a study of aps03118 in advanced solid tumors harboring ret mutations or fusions

Conditions: RET-altered Solid Tumors

Summary: this is a phase 1, open-label, first-in-human (fih) study designed to evaluate the safety, tolerability, pharmacokinetics (pk) and preliminary antineoplastic activity of aps03118 administered orally in participants with ret-altered solid tumors.

after being informed about the study procedure and potential risks and benefits, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. the eligible participants will be enrolled using a rolling 6 dose escalation scheme to identify mtd and/or rp2d.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18 years or older 2. have histological or cytological confirmation of unresectable locally advanced or metastatic solid tumors harboring oncogenic ret mutations or fusions confirmed by ngs. site may identify patients with a ret-mutated or ret-fusion solid tumor before the formal screening. 3. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 4. resolution of all toxic effects of prior therapies to grade 1 or below according to nci ctcae version 5.0 (except alopecia or grade 2 neuropathy); 5. patients with asymptomatic brain metastases if they have been previously treated, demonstrated no progression at least for 1 months before screening, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before screening 6. adequate organ function exclusion criteria: 1. have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy. 2. have an active fungal, bacterial, and/or active untreated viral infection 3. the patient has a serious pre-existing medical condition(s) 4. have received or will receive a covid-19 vaccine within 1 month before the first dose of aps03118.
video education intervention in the emergency department

Conditions: Pain

Summary: the purpose of this study is to evaluate if an educational video viewed during the emergency department visit will improve parent knowledge of pain management, reduce parent anxiety, and change their use of analgesics at-home after discharge from the emergency department.

this study will investigate the use of a video instruction for parents just prior to discharge on pain treatment for their child. the investigators plan to investigate the effect of the video on knowledge because educational modules in the form of videotapes have been shown to be an effective method to improve a parent's knowledge about pain management prior to surgical procedures. because parental anxiety has a significant impact on a child's experience of pain and video education has been shown to reduce parent anxiety before a procedure, the investigators will also evaluate if parental anxiety is reduced. whether or not a short video will change the behavior of parents or their satisfaction with the outcome at home has not been investigated and will be an exploratory hypothesis for this study. this research will be a first step towards optimizing the outpatient care for common diagnoses in the emergency department.

Eligibility criteria:
inclusion criteria: * complaint of pain or injury and laceration, fracture or spring, contusion, crush injuries, head injury, motor vehicle collision, or burn. exclusion criteria: * non- english speaking parents * primary caregiver not with child in emergency department

Keywords: pediatric pain
italian angelman syndrome registry protocol

Conditions: Angelman Syndrome

Summary: the italian angelman registry is a national registry for patients with angelman syndrome. no experimental intervention is involved in participation. the data provided are stored in the registry according the eu general data protection regulation (gdpr, enforced on 25 may 2018), unless participants wish to withdraw their child/ adult's information from the registry.

parents/caregivers of a child or an adult with angelman syndrome living in italy are eligible to insert data in this registry. the individuals must have a diagnosis of angelman syndrome confirmed by genetic testing results. the registry has been launched in february 2018 in coincidence with the international angelman day and the recruitment will be open until february 2021.

Eligibility criteria:
inclusion criteria: * molecular diagnosis of angelman syndrome exclusion criteria: * does not meet diagnostic criteria for angelman syndrome other medical or genetic disorders (except autism)

Keywords: angelman syndrome caregivers parents rare diseases registries
effectiveness of advisor-teller money manager

Conditions: Substance Abuse; Dual Diagnosis

Summary: va investigators have described greater substance use at the beginning of the month when disability and other monthly checks are received. the proposed research addresses an important va priority�seeing that veterans� funds are spent to improve veterans� quality of life and are not misspent on substances of abuse.

background: va investigators have described greater substance use at the beginning of the month when disability and other monthly checks are received. the proposed research addresses an important va priority�seeing that veterans� funds are spent to improve veterans� quality of life and are not misspent on substances of abuse. objectives: the objective was to determine the effectiveness of a money management-based therapy called atm for veterans who abuse cocaine or alcohol compared to a financial advice control condition. methods: veterans were randomly assigned to 36-weeks of atm or to the control condition, financial advice. atm (adviser-teller money manager) involves meeting with a money manager at least weekly. the money manager performs three functions�limiting patients� access to funds by storing checkbooks and atm cards, training patients to budget their funds, and linking spending to treatment goals. the control condition involved listing income and expenses in a workbook. veterans were enrolled from each of two sites if they had spent at least $100 in the preceding 90 days on alcohol or cocaine, and had at least $300 per month income. measures of treatment fidelity and participation included number of visits attended, whether funds were stored, monthly income and expenses and likert-scaled ratings from 1-4 of money management-related outcomes. outcome measures collected included urine toxicology tests and breathalyzers, self-reported substance use as assessed by the asi follow-up, and secondary measures including quality of life and psychiatric symptomatology. status: data analysis is ongoing. attempts are being made to (a) disseminate atm and assess its effect among homeless women veterans (b) determine the reliability and validity of money management-based assessments used to determine which veterans are capable of managing their funds (c) optimize funds management by disabled veterans.

Eligibility criteria:
inclusion criteria: age _\>18. meets dsm-ii criteria for cocaine abuse or alcohol abuse. self-reported use of at least $100 worth of alcohol or cocaine during 30 days within last 90 days. income of at least $300 per month. exclusion criteria: currently receives money management, physiological dependence on alcohol or opiates, has a conservator or other payee