Kornimate/medical-research-clean huggingface dataset:
asp1517 pharmacokinetics study in anemia patients on hemodialysis

Conditions: Anemia; Hemodialysis; Renal Impairment

Summary: to assess the pharmacokinetics and pharmacodynamics of single doses of asp1517 in renal anemia patients on hemodialysis. safety and tolerability will be also evaluated in these patients.


Eligibility criteria:
inclusion criteria: * chronic renal failure patients receiving hemodialysis thrice weekly * body weight: \>=40.0 and \<80.0 kg * mean hemoglobin level \>=10.0 and =\<12.0 g/dl exclusion criteria: * patients with severe inflammation or infection * patients who have a medical history of gastrointestinal surgery or enterectomy * patients who have uncontrolled hypertension * patients whose ast, alt, total bilirubin, ggt exceed the uln or those who have a medical history of serious liver diseases * patients who have a medical history of severe cardiac or cerebrovascular diseases * patients who have received blood transfusion or who have had a surgery (except surgery for a shunt) within 4 weeks * patients with a medical history of serious drug allergies * patients who may be pregnant or lactating, or who refuse to use required birth control during the study period

Keywords: fg-4592 asp1517 safety and tolerability plasma concentration pharmacokinetics
treatment study comparing medium or high dose uva-1 treatment 3x/week versus fluocinonide 0.05% cream in the treatment of morphea.

Conditions: Symmetric Limited Morphea

Summary: compare uva-1 phototherapy treatment to topical steroid treatment in subjects with morphea.


Eligibility criteria:
inclusion criteria: * male and female subjects 18 years of age or older. * symmetric limited morphea. exclusion criteria: * known sensitivity to fluocinonide 0.05% cream. * clinical evidence of superinfected skin. * immunocompromised state (including previously documented hiv). * generalized scleroderma. * previous history of skin cancer. * non-english speaking subjects.

Keywords: morphea plaque morphea localized scleroderma
4d-150 in patients with macular neovascularization secondary to age-related macular degeneration

Conditions: Macular Neovascularization Secondary to Age-Related Macular Degeneration

Summary: a phase 3, randomized, double-masked, active-controlled trial in adults with macular neovascularization secondary to age-related macular degeneration


Eligibility criteria:
inclusion criteria: * ≥50 years of age at time of consent * treatment naïve mnv secondary to namd in the study eye * active subfoveal mnv or juxtafoveal/ extrafoveal mnv with a subfoveal component (where activity is defined as evidence of srf, irf, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (fa) or spectral domain optical coherence tomography (sd-oct), in the study eye, at the screening visit confirmed by the reading center * demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the reading center * bcva between 25 and 78 etdrs letters, inclusive (20/320-20/32 snellen equivalent) in the study eye at the screening visit exclusion criteria: ocular conditions: * mnv due to causes other than namd in either eye (fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)) * history of retinal detachment in the study eye * history of or presence of active inflammation in either eye * glaucoma or intraocular hypertension requiring more than 2 topical medications for control systemic conditions and considerations: * major illness or major surgical procedure in the 28 days prior to the screening visit * uncontrolled blood pressure * acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the screening visit * history of autoimmune condition that may predispose to the development of uveitis

Keywords: age-related macular degeneration amd exudative amd neovascular amd exudative age-related macular degeneration neovascular age-related macular degeneration wet age-related macular degeneration wet macular degeneration wet amd wamd retinal gene therapy intravitreal gene therapy genetic medicine ocular gene therapy namd
micafungin versus ambisome in invasive candidiasis and candidemia

Conditions: Candidiasis

Summary: the purpose of this study is to determine the efficacy and safety of micafungin (fk463) versus liposomal amphotericin b (ambisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. enrollment will include adult and pediatric patients.

a phase iii, multicenter, double-blind, comparative, parallel, randomized study. enrollment will include adult and pediatric patients. the adult population is sized to test for non-inferiority. for the pediatric population, descriptive analyses are planned.

Eligibility criteria:
inclusion criteria: patients either non-neutropenic with absolute neutrophil counts \>= 500 cells/mm3 or neutropenic with absolute neutrophil counts \< 500 cells/mm3 must have: * candidemia or invasive candidiasis, * confirmation and typical clinical signs and symptoms by fungal culture and/or histology, * positive culture obtained no more than four days prior to the first dose of study medication. exclusion criteria: * patient is pregnant or nursing * patients with evidence of liver disease as defined by: a) sgot/ast or sgpt/alt \> 10 times the upper limit of normal (uln); or b) total bilirubin \> 5 times uln. * patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures of urine specimens, sputum specimens, bronchoalveolar-lavage specimens or samples from indwelling drains. * patients who have received prophylactic/empiric therapy with azoles or conventional amphotericin b for more than three days within one week prior to enrollment. neutropenic patients, however, may have received prophylactic azoles without time restrictions.

Keywords: candidaemia micafungin
phase i study of ixabepilone plus lapatinib with or without capecitabine in the treatment of human epidermal growth factor receptor 2 (her2)-positive breast cancer

Conditions: Locally Advanced or Metastatic Breast Cancer

Summary: the purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (her2)-positive or metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast * radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a t4 tumor and stage iiib/iiic disease) and not curable by local measures, such as radiation or surgery * positive status for human epidermal growth factor receptor 2 * measurable disease as per response evaluation criteria in solid tumors guidelines * karnofsky performance status of 70 to 100 * life expectancy of at least 3 months exclusion criteria: * prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine * common terminology criteria grade 2 or greater neuropathy * inadequate hematologic, hepatic, or renal function * known prior severe hypersensitivity reactions to agents containing cremophor® el or known hypersensitivity or prior intolerance to fluoropyrimidine * known or suspected dihydropyrimidine dehydrogenase deficiency * more than 3 prior chemotherapy regimens in the metastatic setting * prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
pharmacogenomic contributions to trihexyphenidyl biotransformation and response in children with dystonic cerebral palsy

Conditions: Pediatric Disorder; Genetic Predisposition; Dystonia, Secondary; Dystonia; Cerebral Palsy, Dystonic-Rigid; Cerebral Palsy, Dyskinetic; Trihexyphenidyl Adverse Reaction; Pharmacogenomic Drug Interaction

Summary: this study looks at how a medicine called trihexyphenidyl works in children with dystonic cerebral palsy. the study aims to understand how trihexyphenidyl is broken down and used in the body of pediatric patients and whether this is impacted by a person's genetics. information from this study will also be used to design future clinical trials.

this is a 16-week single-arm nonrandomized pilot study of trihexyphenidyl in children with dystonic cerebral palsy (dcp) to 1) evaluate the pharmacokinetics (pk) of trihexyphenidyl (thp) and variation in pk parameters between cyp2d6 and cyp2c19 genotypes and 2) evaluate the feasibility of a future exposure-controlled clinical trial of thp.

Eligibility criteria:
inclusion criteria: * ages 5-17 years of age * diagnosis of cerebral palsy and dystonia causing interference * parent/legal guardian of a child with a diagnosis of cerebral palsy and dystonia * parent/legal guardian is willing and able to provide informed permission/assent for the study exclusion criteria: * previously or currently taking trihexyphenidyl * patients turning 18 years of age within the study period (16 weeks from study day 1) * a language barrier for the patient that precludes communication and/or the ability to complete study-related requirements

Keywords: pediatric cerebral palsy dystonia pharmacogenomics trihexyphenidyl
suturing vs biological adhesive in simple lacerations of hand

Conditions: Lacerations

Summary: to assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive.


Eligibility criteria:
inclusion criteria: * any age * hand laceration distal to the volar wrist crease. exclusion criteria: * fracture , tendon, artery involvement, more than 8 hours from laceration to trx, * immunosuppression * anticoagulation therapy * diabetes * unable to achieve homeostasis in more than 15 minutes * unwilling to participate in the study * unable to participate in the follow up or bite of any kind.

Keywords: hand laceration bioadhesive er hand laceration distal to the volar wrist crease
circulating extracellular exosomal small rna as potential biomarker for human pancreatic cancer

Conditions: Pancreas Adenocarcinoma

Summary: this study is for the verification of biomarkers for pancreatic cancer treatment using small rna liquid biopsy, combined with eus-fna tissues.

ca19-9 is the fda approved biomarker for the diagnosis of pancreatic cancer. however, the specificity of ca19-9 to differentiate between pancreatic cancer, cholangiocarcinoma, or other pancreatic lesions is not satisfying enough. tumor cells secret abundant exosomes in the early stage. circulating tumor cells are detected mainly in the advanced stage. meanwhile, the role of non-coding rna draws more and more attention in tumor area. exosomes protect inside rna from plasma rnase. compared with long rna, small rna, including mirna, snorna, trna, pirna could exist more stably. by means of next-generation sequencing, we look forward to finding new exosomal small rna biomarkers.

Eligibility criteria:
inclusion criteria: * age \>18 * pancreatic cancer patients * pancreatic lesions other than paad * chronic pancreatitis * cholangiocarcinoma exclusion criteria: * diagnosed with other pathological types of cancer * treated with chemo/radio/surgery previously

Keywords: exosome snorna endoscopic ultrasound liquid biopsy
a clinical investigation of the balance® microplasty™ hip system

Conditions: Osteoarthritis, Hip; Rheumatoid Arthritis; Avascular Necrosis

Summary: the purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the balance® microplasty™ hip system.


Eligibility criteria:
inclusion criteria: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis. * correction of functional deformity. * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. * revision of previously failed femoral head resurfacing component exclusion criteria: absolute contraindications include: * infection, * sepsis, * osteomyelitis. relative contraindications include: * uncooperative patient or patient 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, or neuromuscular disease.

Keywords: total hip arthroplasty total hip replacement minimally invasive microplasty
tdcs for post-stroke cognitive impairment

Conditions: Stroke; Mild Cognitive Impairment

Summary: this study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in participants with post-stroke cognitive impairment (psci).

the goal of this study is to learn important information about the effects of electrical stimulation (transcranial direct current stimulation (tdcs) on brain functioning in those with post-stroke cognitive impairment (psci). the findings will help determine how stimulation affects the brain's activity, cerebral blood flow, and circulating blood biomarkers of neuroinflammation after stroke. the study will use different forms of non-invasive brain imaging to see whether stimulation changes how the brain responds during a memory task. functional near-infrared spectroscopy (fnirs) and electroencephalograph (eeg) will be used, we will also collect blood samples for the biomarkers of inflammation. the study also uses cognitive tests and questionnaires.

Eligibility criteria:
inclusion criteria: 1) ischemic stroke participants in sub-acute phase (at least 10 days after stroke event or discharge and under 5 months post-event) with cognitive dysfunction (moca \<26); exclusion criteria: 1. clinically significant or unstable medical or psychiatric condition; 2. diagnosis of severe depression; 3. history of relevant neurological diagnosis (e.g., epilepsy); 4. previous neurosurgical procedure with craniectomy; 5. contraindications to tdcs (implanted brain medical devices); 6. severe visual impairment, hearing impairment, aphasia, neglect or dementia.

Keywords: post-stroke cognitive impairment
updrs-iii comparisons of dbs for pd between patients receiving mac and aaa anesthesia

Conditions: Parkinson Disease; Anesthesia

Summary: compares the patients' scores of updrs-iii before and six-month after receiving deep brain stimulation for parkinson's disease under mac or aaa anesthesia.

compares the patients' scores of updrs-iii before and six-month after receiving deep brain stimulation for parkinson's disease under mac or aaa anesthesia. besides, the research also compares the adverse events, led, dosage of anesthetic drugs, wake-up time, surgical time, hoehn\&yahr, pqd-39, mmse, moca, hama, hamd and patients' satisfaction between the two groups mentioned above.

Eligibility criteria:
inclusion criteria: * age greater than 18 years old * diagnosis of primary parkinson's disease * parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications. exclusion criteria: * refusal to participate in the research * patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder * previous functional neurosurgery: dbs, thalamic incision, etc.

Keywords: parkinson's disease updrs-iii deep brain stimulation mac aaa
pilot study of the effect of iron fortified rice in iron deficient anemic women

Conditions: Iron Deficiency Anemia

Summary: the purpose of this study is to see if rice enriched in iron will help women with iron-deficient anemia restore their blood counts more efficiently than the standard rice not enriched with iron.

the study will consist of 1 screening visit and 3 study visits. the two-week study will be scheduled to be between menses. you will then be assigned to eat regular rice dishes or rice dishes fortified with iron for the two-week period. the assignment to the rice group will be made randomly (like flipping a coin). your chance of being in either rice group will be 50:50. you will be given 14 frozen rice meals in styrofoam containers to take home. you will be expected to eat two rice dishes per day for the next study week and to bring the empty containers to your next study visit.

Eligibility criteria:
inclusion criteria: * are a healthy woman. * are between 18 and 50 years of age. * have iron deficient anemia. exclusion criteria: * are pregnant or nursing. * are taking a medication or supplement to treat iron deficiency. * treatment for iron deficiency within the past month * type 1 or type 2 diabetes * ongoing cancer * active auto-immune disease * chronic infections (e.g. hiv/aids, hepatitis b, hepatitis c) * chronic kidney disease * liver cirrhosis * history of drug or alcohol abuse within the past 6 months * history of eating disorder within the past 6 months * any gastrointestinal surgery affecting nutrient absorption

Keywords: iron deficiency anemia rice
the effect of nasal cannulae during the first 2 hours postoperative in patient undergoing thoracotomy

Conditions: Hypoxia; Post Pulmonary Resection

Summary: at our institute,during the first 2 hour postoperative, we used to give supplement oxygen via face mask in patient having lung resection surgery. after then if the patient is fine, we'll replace the face mask with nasal cannular untie the next morning. we hypothesized that oxygen mask can be replace by nasal cannular without any hypoxia.


Eligibility criteria:
inclusion criteria: * age \>/= 18 years old * patient undergoing lobectomy or pneumonectomy or wedge resection * asa 1-3 * preoperative oxygen saturation \< 95 % exclusion criteria: * cannot communication

Keywords: hypoxemia post pulmonary resection
enhancing the detection and management of adverse drug events in nursing homes

Conditions: Adverse Drug Events

Summary: adverse drug events (ades) are the most clinically significant and costly medication-related problems in nursing homes (nh) and are associated with an estimated 93,000 deaths a year and as much as $4 billion of excess healthcare expenditures. current ade detection and management strategies that rely on pharmacist retrospective chart reviews (i.e., usual care) are inadequate. active medication monitoring systems are recommended by many safety organizations as an alternative to detect and manage ades. these systems have been shown to be less expensive, faster, and identify ades not normally detected by clinicians in the hospital setting. the investigators developed and pilot-tested an active medication monitoring system for use in a single nh, where it was shown to detect ades with a high degree of accuracy and at a rate of nearly 2.5 times that of usual care. the long-term objective of our proposed research is to improve patient safety with respect to medications in nhs. the short-term objectives or specific aims of our proposed research are to determine if nh patients managed by physicians who receive active medication monitoring alerts have more ades detected, have a faster ade management response time, and can result in more cost-savings from a societal perspective compared to usual care.

to accomplish the aims outlined in our brief summary above, the investigators will conduct a cluster randomized controlled trial among up to 86 nh physicians working in one of 4 upmc health system nursing homes (nhs) in southwestern pennsylvania for a period of 12 months. our hypotheses are that nh patients managed by physicians who receive active medication monitoring alerts will have more ades detected, will have a faster ade management response time, and will result in cost-savings from a societal perspective compared to usual care. this application by an early stage investigator is responsive to pa-09-070 ahrq health services research projects and several of its research portfolio priority areas (health information technology, patient safety, and value) by addressing how medication management systems can be used to improve the quality and safety of medication management, as well as improve healthcare decision making. this study represents the first large, well-controlled, comprehensive examination of an active medication monitoring system in the nh.

Eligibility criteria:
inclusion criteria: all physicians participating in the study must be a credentialed attending physician at at least one of four upmc nursing homes: upmc canterbury place, upmc cranberry place, upmc heritage place, and/or upmc seneca place. exclusion criteria: physicians not credentialed as an attending physician at at least one of four upmc nursing homes: upmc canterbury place, upmc cranberry place, upmc heritage place, and/or upmc seneca place.

Keywords: nursing home
analyses of anemia in very low birth weight (vlbw) infants.

Conditions: Very Preterm Maturity of Infant; The Risk Factors for Improving the Prognosis of VLBW Infants

Summary: to study and analyze the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life (less than 3 days of life) among the very low birth weight (vlbw) infants.

the rescue treatment of very low birth weight (vlbw) infants is the main task of our neonatal intensive care unit (nicu) is this era. anemia of prematurity (aop) is one of the most common complication of these infants, which can affect their growth, intelligence, behavior, immunity and hemodynamics, and even endanger their lives in severe situation. it is of great significance to investigate the association of the severity of anemia with neonatal morbidity and the risk factors of anemia in ealry life for improving the prognosis of these infants. patient registry procedures: first, the list of vlbw infants was obtained through medical record search, and sent to the principal investigator (pi) at each center when an infant was eligible for enrollment. second, patients are included in this study according to the exclusion criteria by pi. finally, the pi at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection. statistical analysis:the two groups were compared by a χ2-test for categorical variables, mann-whitney u test were used when reporting medians.a p value of \<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * preterm infants less than 32 weeks of gestational age and birth weight below 1500 g and who survive to nicu are eligible for the trial. * anemia was defined as a central venous hemoglobin harvested in the first 3 days of life less than two standard deviations below the mean for postnatal age. exclusion criteria: * asphyxia (arterial ph \<7.0, fifth minute apgar score \<3), * twin-to twin-transfusion syndrome, * discordant twins (difference in birth weight \>20%), * major congenital anomalies or chromosomal anomalies, * disagree of parents.

Keywords: vlbw anemia risk factors prognosis