Kornimate/medical-research-clean huggingface dataset:
implementation of a web based real time clinical decision support tool.

Conditions: Critical Illness; Sepsis; Respiratory Failure; Shock; Bleeding

Summary: in the developed world critical illness is routinely treated in an intensive care unit (icu) by highly specialized physicians, nurses and support staff. this model of intensive care is spreading rapidly to low and middle income countries and as it spreads, challenges and limitations to this model arise. in resource-poor settings, inadequate human resources, training, and equipment all present barriers to safe and effective use of life-saving procedures. the advances in medical informatics and human factors engineering have provided tremendous opportunity for novel and user-friendly clinical decision support (cds) tools that can be applied in a complex and busy hospital setting. real-time data feeds and standardized patient care tasks in a simulated acute care environment have been proven to have a significant advantage of a novel interface (compared to a conventional) in reducing provider cognitive load and errors. currently researchers within the investigator's research group have developed and are pilot testing a simple electronic decision support tool: certain (checklist for early recognition and treatment of acute illness). this tool has been successfully tested and validated in simulated settings and is being implemented as pilot study in 18 countries. worldwide infant and early childhood mortality continues to be very high partly due to the inability to recognize and respond aggressively to critical illnesses. investigators expect that adaptation of the algorithms from certain has potential to be a powerful tool to improve on the medical care of children in developing countries. investigators aim in this project is 1) to develop a pediatric adaptation of certain (certainp) and 2) to implement it into clinical practice in resource-poor settings and evaluate the impact of the tool on the processes and patient outcomes.


Eligibility criteria:
inclusion criteria: * all pediatric patients (\< 18 years) admitted for the first time to the participating picus will be included. exclusion criteria: * not critically ill, admitted for low risk monitoring, planned picu admission for routine post operative surveillance for less than 24 hours after uncomplicated surgery, readmission and transfer from outside picu.
stakeholder assessment of implementing the commission on cancer operative standards for cancer surgery

Conditions: Breast Carcinoma

Summary: this study investigates the barriers to implementing breast synoptic operative reports. information from this study may help researchers identify performance objectives for the breast synoptic operative reports to be adopted, implemented and continued.

primary objectives: i. to identify and describe barriers to implementing breast synoptic operative reports (sor) from multiple constructs. ia. identify performance objectives - who must do what - for the breast sor to be adopted, implemented, and continued. outline: participants participate in interview over 30-60 minutes.

Eligibility criteria:
inclusion criteria: * adults \>= 18 years * available phone or device for contact * english speaking * works at commission on cancer (coc) - accredited cancer program exclusion criteria: none
surveillance of azole resistance in aspergillus isolates in taiwan

Conditions: Infection; Aspergillus

Summary: primary objectives: 1. to investigate the prevalence of azole resistance in aspergillus clinical isolates collected in participating hospitals in taiwan 2. to investigate the prevalence of azole resistance in aspergillus environmental isolates in taiwan 3. to characterize the molecular mechanisms of azole resistance in aspergillus isolates in taiwan 4. to investigate the clonality of aspergillus clinical and environmental isolates in taiwan 5. to describe the genetic relationships between local resistant strains with global strains secondary objective: 1. to describe the clinical characteristics and treatment outcome of patients with proven or probable invasive aspergillosis 2. to evaluate the clinical impact of azole resistance in patients with proven or probable invasive aspergillosis in a case-control study

cumulative evidence described the emergence and geographical expansion of azole-resistant aspergillus fumigatus associated with azole treatment failure. multiple amino acid substitutions in the cyp51a gene have been described to be associated with azole resistance that emerges during azole treatment, while a resistance mechanism, tr34/l98h mutation in cyp51a, has been linked to the agricultural use of azole fungicides in europe, which have also been widely used in taiwan for years. the current prevalence of azole-resistant aspergillus isolates and mechanisms of azole resistance in taiwan is not clear. considering the potential of geographic migration of resistant isolates from neighboring countries and the possibility of emergence of locally revolved resistant strains, this 2-year multi-center project aims to investigate the prevalence rate of azole resistance in aspergillus clinical and environmental isolates, to determine the molecular mechanisms of azole resistance, and to describe the clinical characteristics and treatment outcome of aspergillus diseases in taiwan. clinical and environmental aspergillus isolates will be collected and examined, and clinical data from patients with aspergillus diseases or colonization will be retrieved and analyzed. through this study the investigators anticipate increase in awareness of prevalence and impact of azole resistance in patient safety in participating hospitals. in addition, the investigators may update taiwan treatment guideline for aspergillosis on the basis of these evidence and knowledge.

Eligibility criteria:
for primary objectives inclusion criteria: * patients with one or more clinical specimens culture positive of aspergillus exclusion criteria: * is not a human pathogen of aspergillus * no clinical data available for secondary objectives (a case-control study in a 1:4 ratio) inclusion criteria: * patients with proven or probable invasive aspergillosis case patients: patients infected by azole-resistant isolates control patients: patients infected by azole-susceptible isolates

Keywords: aspergillus antifungal susceptibility azole resistance
efficacy and safety of diamyd® in children and adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this is a randomized, placebo-controlled phase ii study to investigate if a prime and boost of 20ug diamyd® (rhgad65 formulated in alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.


Eligibility criteria:
key inclusion criteria: * male and female patients between 10 and 18 years of age, diagnosed with type 1 diabetes within 18 months * fasting c-peptide level above 0.1 nmol/l * presence of gad65 antibodies * written informed consent (patient and parent/guardian) key exclusion criteria: * secondary diabetes mellitus or mody * treatment with immunosuppressants * treatment with any vaccine within 1 month prior to first diamyd® dose or planned treatment with vaccine up to 2 months after the second diamyd® dose * participation in other clinical trials with a new chemical entity within the previous 3 months * history of certain diseases or conditions (e.g. epilepsy, anaemia, alcohole or drug abuse) * hiv or hepatitis * presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study * pregnancy (or planned pregnancy within one year after 2nd administration)

Keywords: type 1 diabetes gad65 autoimmunity c-peptide children
adherence intervention for minority children with asthma

Conditions: Asthma

Summary: to evaluate the effectiveness of a head start-based early intervention for designed to improve asthma management skill and practices of parents, pre-school children and head start staff.

background: while increased asthma morbidity and mortality have been observed across all ethnicities, results from several studies have found that asthma morbidity has increased disproportionately in low-income african american children. elementary school-based asthma education programs have shown promise in improving asthma management, and reducing asthma morbidity in this high-risk population, however, the fastest growing asthma risk is associated with children young than six. by elementary age many parents and children with asthma have well-established patterns of inappropriate asthma management that may be difficult to change. to date, no research has examined the impact of early intervention for asthma management in low-income, high-risk children. design narrative: the primary outcome that the study was designed to evaluate medical record documented emergency care for asthma at the jhped over the eighteen-month follow-up period. the secondary outcomes adherence with asthma therapy based on medicaid pharmacy claims for asthma medications, other asthma health care (urgent and primary), self-reported medication adherence, barriers to health care, restricted activity, nighttime symptoms, asthma medications, self and family asthma management behaviors, asthma management self-efficacy, functional status, and quality of life. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
1. age 2-12 years. 2. a current diagnosis of asthma or reactive airway disease 3. resident of baltimore city. 4. two or more ed visits at the jhped for asthma in the past 12 months, or hospitalization for asthma at the jhped in the past 12 months by parent report. 5. not currently participating in other research studies (participation in previous studies will be noted).
choices3: sickle cell disease parenting choices

Conditions: Sickle Cell Disease; Sickle Cell Trait

Summary: the study will use web-based data collection (scknowiq) and intervention delivery strategies enhanced by nudges and tailored boosters in a sample of 430 adult men and women, aged 18-45 yr with scd (sickle cell disease) or sct (sickle cell trait), at-risk, and planning within 2 years to have a child free of scd.

in a 2-year, randomized, longitudinal, repeated measures, controlled trial in 430 at-risk young adults with scd (50%) or sct (50%) to compare the effects of e-book (electronic-book) and choices interventions on knowledge and behaviors across time (baseline, immediate posttest, 6, 12, 18, 24 months). the study will provide boosters tailored to knowledge deficits at 6 and 12 months and add monthly reinforcement nudges toward concordant behavior during the first 12 months.

Eligibility criteria:
inclusion criteria: * diagnosis of scd (hbss, hbsc (hemoglobin sickle c disease), hbs-beta-0 thalassemia, and hbs-beta+ thalassemia) or report of sct (scd is hgb electrophoresis confirmed; sct evaluated by sicklescan); * able and intends to conceive a child in the next 2 years (first child or another child); * speaks and reads english; * 18 to 45 years; * at-risk for having a child with scd (i.e., sexual/ reproductive partner has scd, sct, or unknown sickle cell status); and * wants to avoid the risk of a child with scd. * the age range is based on typical reproductive age for scd where median survival is 42 years for men and 48 years for women. exclusion criteria: * legally blind; * physically unable to complete the study questionnaires or the intervention; * report health history of hysterectomy, tubal ligation, medically or surgically induced menopause, or vasectomy that would * prevent ability to bear children; * report a desire to remain childless or have no further children; * report knowing or being a relative or friend of a participant previously enrolled in the study, or * previous participation in a choices study.
diagnostic study to predict the risk of developing metastatic cancer in patients with stage i or stage ii melanoma

Conditions: Melanoma (Skin)

Summary: rationale: diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer. purpose: this clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage i or stage ii melanoma.

objectives: * correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage i or ii melanoma. * correlate melastatin expression prospectively with event-free survival of these patients. outline: this is a multicenter study. melastatin mrna expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. tissue is also examined by immunohistochemical staining using antibodies to s-100 and mart-1. patients do not receive the results of these tests nor do the results influence individual therapy. patients are followed every 4 months for 3.5 years. projected accrual: a total of 300 patients will be accrued for this study within 3.5 years.

Eligibility criteria:
1. histologically documented primary ajcc stage i or ii melanoma. evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted. 2. patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma. 3. ≥18 years of age 4. patients must be registered prior to planned surgery. the surgery must be performed within 45 days following registration. 5. no concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma. 6. tissue blocks: one of primary tumor tissue taken from region of greatest breslow thickness. note: if blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.

Keywords: stage i melanoma stage ii melanoma
efficacy and safety of topical insulin for neurotrophic corneal ulcers

Conditions: Neurotrophic Keratopathy

Summary: to evaluate safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers

neurotrophic keratopathy is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation. a reduction in corneal sensitivity or complete corneal anesthesia is the hallmark of this disease and is responsible for producing epithelial keratopathy, ulceration and perforation. because decreased corneal sensitivity is the hallmark sign of neurotrophic keratitis (nk), corneal sensitivity testing should be performed as soon as it is suspected there are 2 common ways to test-one qualitative, the other quantitative: the qualitative method is most commonly used in clinic and often achieved with a cotton tipped applicator because it is easily accessible. the most common quantitative method is the handheld esthesiometer (cochet-bonnet). standard treatment of neurotrophic corneal ulcer involves aggressive lubrication of the corneal surface, therapeutic contact lenses, amniotic membrane grafts and tarsorrhaphy . refractory neurotrophic corneal ulcers occur when treatment response is incomplete and are potentially blinding. insulin is a widely available, relatively safe, and familiar medication that has been shown to improve corneal epithelial healing in vitro and in diabetic animal models. however, clinical experience with topical insulin in patients with non-healing corneal wounds is minimal. insulin-like growth factor-1 (igf-1) has been shown to be an important modulator of corneal wound healing. topical insulin may be a simple and effective treatment for neurotrophic corneal ulcers. the main outcome measurements for improvement are the decrease of ulcer size by fluroscien stain,the increase in visual acuity.

Eligibility criteria:
inclusion criteria: * patients with neurotrophic corneal ulcers caused by: * herpes simplex or herpes zoster viral infection * topical anesthetics abuse * chemical and physical burn * chronic cl wear * following lasik,prk,cxl * following vitrectomy and endophotocoagulation for retinal detachment * diabetes mellitus * leprosy * trigeminal neuralgia surgery exclusion criteria: * non compliant patients with the study protocol
a chart review of rituximab plus repeated cycles of dexamethasone

Conditions: Idiopathic Thrombocytopenia Purpura

Summary: in this prospective and retrospective chart review, investigators will evaluate the response rates and duration of response for patients with relapsed and refractory idiopathic thrombocytopenic purpura (itp) who have been treated with rituximab and repeated courses of dexamethasone. investigators will also evaluate observed toxicities of the combination, and characteristics associated with response.

patients with idiopathic thrombocytopenic purpura (itp) usually respond with an increase in platelet count after treatment with steroids, but most patients will experience recurrence.rituximab has been a useful treatment for patients with recurrent itp; many hundreds of patients have been treated. 30-40% of patients will achieve a complete remission (cr: platelet count \>150 x 109/l) with initial treatment. however, most patients will relapse between 1 and 3 years from initial treatment suggesting that long-term "cures" only occur in 20% of the initial patients. an increased rate of durable crs is therefore a desirable goal. one approach would be to use rituximab maintenance; however, this strategy results in long term b cell suppression. dexamethasone has also been used to achieve "cure" in itp, especially in adults at or near diagnosis. an initial study suggested that approximately 50% of patients would achieve a long-term response with only one 4-day cycle of high dose (40 mg/day) dexamethasone. a follow up study suggested that 3-4 cycles of dexamethasone would be better than 1 cycle. finally, a recent publication suggested that rituximab plus one cycle of dexamethasone was superior to dexamethasone alone, with a \> 50% cr rate at 6 months. based on the published activity of rituximab and dexamethasone in this disorder, some patients have received treatment with combined dexamethasone and rituximab. we will review the data of those patients who have received more than one course of dexamethasone together with rituximab for relapsed or refractory itp in order to determine the response rate, duration of response, toxicity of the combination, and clinical predictors of response in this group.

Eligibility criteria:
inclusion criteria: 1. subjects must be diagnosed with itp. 2. subjects must be 3 years old or older 3. subjects must have a platelet count less than 40,000/ul at initiation of treatment regimen or inability to discontinue maintenance treatments such as intravenous immunoglobulin (ivig), corticosteroids, azathioprine, and/or a thrombopoietin receptor agonist. exclusion criteria: 1. subjects who have not been diagnosed with itp. 2 subjects who are younger than 3 years old 3. subjects who have a medical condition that would be adversely affected by high dose steroids

Keywords: platelets are a part of the blood hat helps with clotting itp idiopathic thrombocytopenia purpura low platelet count
minipuberty in infants born with potential hypogonadism hypogonadotrope

Conditions: DSD; CHH

Summary: disorders of sex development (dsd) occur in 1/3000 births and are defined by variation in aspect of external genital organs, e.g. cryptorchidism, hypospadias and micropenis in male infants and clitoral hypertrophy in female infants. genetic, hormonal and environmental factors are implicated in dsd. infants with congenital hypogonadism hypogonadotrope (chh) can present with dsd. evaluation of hormonal profile during minipuberty could be of great help to better characterize the etiology of dsd and chh in particular. our main objective is to study hormonal profile during the minipuberty of infants born with dsd or born from parents with chh compared to controls.


Eligibility criteria:
inclusion criteria: * infants born with symptoms of dsd * infants born from parents with chh exclusion criteria: * premature \< 35 weeks of gestation * male infants with high scrotal cryptorchidism
a 12-weeks study to evaluate sulforaphane in treatment of autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: in this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (asd). the study will recruit 120 asd patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. the specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. biological samples also will be collected, and stored to research related mechanisms.

in this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (asd). the study will recruit 120 asd patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. the specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. the investigators hypothesize that (1) sulforaphane is superior to placebo in the treatment of clinical symptoms in patients with asd, measured by the social responsiveness scale, aberrant behavior checklist, repetitive behavior scale - revised and ohio state university autism clinical global impression; (2) sulforaphane is superior to placebo in the treatment of other behavioral problems and adaptive behaviors patients with asd, measured by achenbach's child behavior checklist and adaptive behavior assessment system, second edition; and (3) biological samples will be collected, and stored so that the hypothesis sulforaphane may alter oxidative stress indexes or inflammatory biomarkers, and influence histone deacetylase inhibitor mechanism or inflammatory mechanism et al that may be significantly correlated with clinical improvement.

Eligibility criteria:
inclusion criteria: 1. aged 3 to 15 years. 2. meet dsm-v diagnostic criteria for autism spectrum disorder, and been checked with autism diagnostic interview-revised (adi-r) and autism diagnostic observation schedule (ados). exclusion criteria: 1. with severe physical disease (i.e. congenital heart disease, thyroid disease, diseases with severe abnormality of liver or kidney function, diseases with abnormality vision or hearing et al.) 2. with severe central nervous system disease (i.e. epilepsy et al). 3. with other specific genetic syndromes (i.e. fragile-x syndrome, down's syndrome et al.)

Keywords: sulforaphane clinic trial autism spectrum disorder efficacy safety mechanism
efficacy of antihistamine drugs as medical expulsive therapy alone or in combination with alpha blockers: a prospective randomized controlled study

Conditions: Lower Ureteric Stones

Summary: we investigate the efficacy of antihistamine drugs as medical expulsive therapy alone or in combination with alpha blockers in distal ureter stone


Eligibility criteria:
inclusion criteria: * all adult patients with lower ureter stone less than 10 mm exclusion criteria: * pregnant, solitary kidney, sensitivity to drugs

Keywords: stones , ureter, tamsulosin