Kornimate/medical-research-clean huggingface dataset:
role of fgf-23 as a prognosis biomarker in intensive care patients

Conditions: Sepsis; Acute Kidney Injury

Summary: the purpose of the study is to evaluate the potential role of plasmatic fibroblast growth factor 23 (fgf-23) as a prognosis predictor of clinical outcomes in critical care patients.

observational study of patients admitted in the critical care unit (ccu) of university of chile clinical hospital, admitted with diagnosis of severe sepsis/septic shock. exclusion criteria: pregnancy, organ transplantation. informed consent is solicited to patients before admission in study. if the patient cannot give it because of his/her clinical condition, it will be solicited to a patient representative. after admission in ccu and achievement of informed consent, a venous blood sample will be obtained, to determinate plasmatic levels of fibroblast growth factor 23 (fgf-23). new samples will be obtained at 24 and 48 hours after admission. determination of fgf-23 will be performed by elisa technique in integrated physiology laboratory. demographics, clinical and biochemical data will also be obtained. the data will be collected by the principal investigator. confidentially of all data will be preserved during and after the completion of the study. the study is divided in 2 parts: 1. - evaluation of a sample of 14 patients to determinate the impact of fgf-23 to predict presence and severity of acute kidney injury (aki), and to estimate sample size to predict primary outcomes. 2. - evaluation of a larger sample, to determinate the impact of fgf-23 to predict primary outcomes. primary outcomes: 1. - development of acute kidney injury 2. - severity of aki, determinate by akin classification 3. - in-hospital mortality secondary outcomes: 1. - requirements of renal replacement therapy 2. - requirements of mechanical ventilation 3. - requirements of vasoactive drugs 4. - duration of icu stay and hospital stay as a post-hoc analysis, we performed a measurement of a combined biomarker, including fgf-23 and other 2 biomarkers, klotho and erythropoietin, measured in blood samples, to determinate its predictive capacity for aki diagnosis and mortality. the protocol was approved by the ethical committee of university of chile clinical hospital. the study is monitored by the clinical investigation support office (oaic) of the hospital.

Eligibility criteria:
inclusion criteria: * admission in critical care unit * sepsis exclusion criteria: * pregnancy * organ transplantation
a study evaluating il28b polymorphism in patients with hbeag-negative chronic hepatitis b treated with pegasys (peginterferon alfa-2a) in study ml18253

Conditions: Hepatitis B, Chronic

Summary: this cross-sectional multicenter study will evaluate the il28b polymorphism in patients with hbeag-negative chronic hepatitis b treated with pegasys (peginterferon alfa-2a) in the predecessor ml18253 study. the study consists of a single visit where eligible patients will undergo a blood test for il28b genotyping, with a phone follow-up 7 days after the visit.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic hepatitis b * previous participation in study ml18253 * administration of at least one dose of the study drug during ml18253 study exclusion criteria: * patients not satisfying the above inclusion criteria will not be enrolled in the study
placental transfusion in term infants: a pilot study

Conditions: Anemia

Summary: the proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. delaying cord clamping has been shown to decrease anemia in infants. however, the best way to get the most blood to the baby is not known. the practice of cord clamping at birth is not the same among doctors and midwives and we do not know the effect of putting he baby on the mother's abdomen.

the proposed study is a pilot prospective controlled trial to measure the placental residual blood volume after varying cord clamping protocols when the infants are placed skin-to-skin on the maternal abdomen. the study assessed compliance of the providers with the different protocols. placental transfusion (pt) has been shown to increase infant body iron stores at 6 months of age without increasing adverse outcomes. however, the optimal protocol to achieve adequate placental transfusion is not known. the practice of cord clamping at birth is not uniform among obstetrical providers because adequate evidence to support early or late cord clamping has been lacking. women were eligible to enroll in the study if they had no pregnancy complications, did not smoke, planned to breastfeed, and planned to deliver vaginally between 37 and 416/7 weeks. women were enrolled prenatally on the labor and delivery unit. at birth, women were assigned to one of four cord clamping/milking groups. a cohort of infants with immediate cord clamping serves as reference group. infants had blood samples drawn with the routine newborn screening blood samples done at 36 to 48 hours. information on infant health and feeding was completed through an in-hospital visit to the mother and by home visit at two weeks of age. the primary outcome measures were placental residual blood volume and compliance with the various assigned cord clamping protocols. it was expected that infants with delayed cord clamping or cord milking would have less placental residual blood volume and that most providers would comply with the various random assignments.

Eligibility criteria:
inclusion criteria: women with normal pregnancy and presented at the labor room at 38-416/7 weeks for vaginal delivery; intention to breast feed the babies; consent for a follow up at 2 weeks of age exclusion criteria: abnormal pregnancy: gestational or pre-existing diabetes, smoking and substance abuse, pre-eclampsia, fetal abnormality

Keywords: umbilical cord clamping placental residual blood volume hematocrit hemoglobin bilirubin
combination chemotherapy, surgery, and radiation therapy in treating children with advanced soft tissue sarcoma

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.

objectives: i. assess the response to vincristine/ifosfamide/doxorubicin (vid) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. ii. estimate the 2-year and event-free survival rates in children treated with vid plus radiotherapy and/or surgery. iii. establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies. outline: the following acronyms are used: dox doxorubicin, nsc-123127 g-csf granulocyte colony-stimulating factor (amgen), nsc-614629 iff ifosfamide, nsc-109724 mesna mercaptoethane sulfonate, nsc-113891 vcr vincristine, nsc-67574 vid vcr/iff/dox induction: 3-drug combination chemotherapy. vid. local control: surgery and/or radiotherapy plus 3-drug combination chemotherapy. excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or co60 beam energies of at least 4 mv (electrons or iridium-192 implant allowed for boost); plus vid. continuation: 3-drug combination chemotherapy. vid. projected accrual: a total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients.

Eligibility criteria:
disease characteristics: biopsy proven non-rhabdomyosarcoma soft tissue sarcoma (nrsts) evaluable residual tumor after initial biopsy or excision required registration required within 42 days of definitive diagnosis grade ii/iii, unresectable or metastatic disease the following histologies exclude: angiofibroma of the nasopharynx mesothelioma desmoid tumor peripheral neuroepithelioma desmoplastic small cell tumor rhabdomyosarcoma extraosseous ewing's sarcoma undifferentiated sarcoma kaposi's sarcoma grade 1 nrsts, including: angiomatoid malignant fibrous histiocytoma dermatofibrosarcoma protuberans myxoid and well-differentiated liposarcoma well-differentiated and infantile hemangiopericytoma well-differentiated malignant peripheral nerve sheath tumor patient characteristics: age: 21 and under performance status: not specified hematopoietic: not specified hepatic: not specified renal: creatinine normal for age no hydronephrosis cardiovascular: shortening fraction greater than 28% other: no hiv infection not pregnant or nursing effective contraception required of fertile women prior concurrent therapy: no prior chemotherapy or radiotherapy no prior nephrectomy (surgical correction of hydronephrosis allowed)

Keywords: nonmetastatic childhood soft tissue sarcoma metastatic childhood soft tissue sarcoma
language in primary progressive aphasia

Conditions: Primary Progressive Aphasia

Summary: the purpose of this study is to further define the neurological and linguistic deterioration in primary progressive aphasia.

the language in primary progressive aphasia (ppa) aims to understand the behavioral, anatomical and physiological changes in people with ppa throughout the course of the illness. the researchers in this study want to increase awareness of ppa, educate others about this unique disorder, and to encourage more research to eventually develop therapies. during the three-day research program, participants will be asked to undergo neuropsychological testing (paper and pencil tests that evaluate cognition), advanced imaging (mri and pet), cognitive experiments, and other computer and language testing batteries. participants may be asked to return every two years to complete the same measures. for participants not living near chicago, il, flights and accommodations (for both the person with ppa and their companion) will be covered by the study.

Eligibility criteria:
inclusion criteria: * diagnosis of primary progressive aphasia * right-handed * native english speaker * visual acuity of 20/30 corrected * adequate hearing to follow conversation * safe for an mri scan exclusion criteria: * left-handedness * claustrophobia * presence of significant medical illness that initially or in the future could interfere with continued participation in the study

Keywords: primary progressive aphasia frontotemporal dementia semantic dementia progressive nonfluent aphasia progressive aphasia frontotemporal lobar degeneration
busulfan pharmacokinetic analysis and gst pharmacogenetic profile in adults undergoing hematological stem cell transplantation

Conditions: Acute Myeloid Leukemia

Summary: the correlation between busulfan pharmacokinetics in aml transplanted patients and their gst (a1,t1,m1 and p1), mdr-1 genetic profile. if a pre-genetic testing of those genes can be utilized as biomarkers of sos and/or hgvhd. this study is not an interventional study it is only checking the gst gene and mdr-1 gene

bu levels are largely unpredictable, patients are often exposed to the toxic effects of inappropriate drug regimens before dose modifications can be made. although the importance of tdm cannot be over emphasized, it entails trial and error and does not allow for pre- treatment dose optimization. this study, which provides an integration of genetic and pharmacokinetic data analysis of patients preconditioned for hsct with high dose oral bu, aims to define biomarkers predictive of poor bu metabolism and clearance to prevent potential drug toxicity.this study is not an interventional study, only investigates the gst and mdr-1 genes in correlation with the "routine" busulfan auc done during the preparative regimen in hsct for aml patients.

Eligibility criteria:
inclusion criteria: * acute myeloid leukemia who are clinically selected for hsct according to known protocols. exclusion criteria: * unable to give informed consent

Keywords: pharmacokinetics busulfan polymorphism gst mdr-1(p-glycoprotein) acute myeloid leukemia adult patients
fluid responsiveness prediction at the bedside

Conditions: Hypotension; Shock

Summary: the purpose of this study is to verify the accuracy and applicability of predictors of fluid administration efficacy in hypotensive critically ill patients.

severe hypotension is a common life-threatening conditions in critically ill patients. discriminating between the need for volume expansion or inotropic/vasoactive support is a main clinical goal. pulse pressure variation are an accurate index of fluid responsiveness, but it needs controlled mechanical ventilation with a tidal volume of at least 8 ml/kg and absence of arrhythmias. this could limit its clinical applicability. moreover pulse pressure variation accurately predicted cardiac output increment. however the cardiac output increase is not a clinically relevant target in absence of low cardiac output. the objectives of the present protocol are: 1) to calculate the accuracy of cardiovascular and renal variables to predict either arterial pressure increase or clinically relevant improvement after fluid administration and 2) to verify how often dynamic indices could be applied in clinical practice. arterial pressure increase is defined by mean arterial pressure above 65 mmhg or an increment greater than 20 % respect to basal value. clinically relevant improvement is defined by restoring adequate values of arterial pressure or cardiac index or diuresis or central venous saturation if they are inadequate before fluid administration. these adequate values are 65 mmhg for mean arterial pressure, 2.5 l.min-1.m-2 for cardiac index, 0.5 ml.kg-1.h-1 for the diuresis, 70 % for central venous saturation.

Eligibility criteria:
inclusion criteria: * mean arterial pressure lower than 65 mmhg exclusion criteria: * fluid overload * mean arterial pressure lower than 45 mmhg and mandatory immediate treatment * active bleeding * hemoglobin lower than 8 g.dl-1

Keywords: shock fluid responsiveness volume expansion
change in biting force after botox injection

Conditions: Bruxism

Summary: implant rehabilitation is a successful treatment option for edentulous patients. decreasing bone loss around implants is an important target for all implantologists. it has been shown that pathological forces, such as bruxism, may in fact result in bone loss and eventual implant failure. botilinium toxin is a material of many clinical uses. beside its cosmetic applications, it has been used in the treatment of masseter muscle hypertrophy. purpose: to investigate the effect of botilinium toxin injection on biting forces, and its ultimate effect on peri-implant bone changes.


Eligibility criteria:
inclusion criteria: * patients with a partially edentulous mandible, kennedy class i configuration, who are indicated for rehabilitation with partial implant overdenture prostheses, and who complained of bruxism. exclusion criteria: * the presence of notable facial asymmetry. * severe malocclusion * pregnancy * a history of any serious medical illness * drug allergy.
a study to evaluate the pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.


Eligibility criteria:
inclusion criteria: * participants with total body weight of 10 kilograms(kg) or higher at baseline. beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study. * diagnosed with atopic dermatitis (ad) with onset of symptoms at least 6 months prior to baseline. * meets hanifin and rajka criteria for ad. * diagnosed with active severe ad defined by eczema area severity index (easi), validated investigator's global assessment (iga) and body surface area (bsa). * documented history (within 12 months prior to the baseline visit) of inadequate response or intolerance to topical corticosteroids (tcs) and topical calcineurin inhibitor (tci) or for whom use of tcs and tcis is otherwise medically inadvisable. exclusion criteria: * prior exposure to janus kinase (jak) inhibitor. * requirement of prohibited medications during the study. * current use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 30 days prior to the first dose of study drug and through the end of part 1 of the study.

Keywords: upadacitinib abt-494 atopic dermatitis rinvoq
retrospective modulus alif study

Conditions: Degenerative Disc Disease; Spondylolisthesis; Stenosis

Summary: the primary objective of this study is to evaluate the safety and performance of the modulus alif system in patients undergoing anterior lumbar interbody fusion (alif) as measured by reported complications, radiographic outcomes, and patient-reported outcomes.

patients considered for this study will have previously undergone surgery for their spinal condition according to the standard of care of the practitioner. all patients at a given site who meet eligibility requirements will be considered for participation in the study. available progress notes, medical records, patient-reported outcomes, radiographs (plain film and ct scans, if available), and complications will be obtained from the medical records of all enrolled subjects. the complication profile and overall performance of the modulus alif system will be assessed using the following: 1. complications attributable to the use of the modulus alif system as noted in surgical summaries, progress notes, and hospital records; and 2. radiographic outcome (fusion) and description of device status from available plain film radiographs and ct scan(s); and 3. neurologic status, symptoms, and/or subject self-reported clinical outcomes (e.g., pain and disability), as available

Eligibility criteria:
inclusion criteria: 1. availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery 2. male or female patients who are ≥18 years of age at the time of surgery 3. had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the modulus alif system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome 4. treated with alif procedure with the modulus alif system at: * one or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (ddd), degenerative spondylolisthesis, or spinal stenosis, or * any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as \>10º coronal curve) or sagittal deformity 5. supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria: * 1-2 levels treated for ddd, and * 3 or 4 interfixated screws placed, and * implant lordosis is ≤20° exclusion criteria: 1. patient was a prisoner at the time of modulus alif treatment 2. patient was participating in another clinical study during treatment that would confound study data
st. mary's duluth clinic (smdc) pacemaker magnetic resonance imaging (mri) study

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to monitor and follow non-pacemaker dependent patients with implanted permanent pacemakers, who undergo medically required magnetic resonance imaging (mri) scans. patients with pacemakers are currently excluded from obtaining mri scans. mri scanning is now the imaging of choice for a number of neurological, vascular, or musculoskeletal conditions. data suggests that patients with pacemakers, when properly monitored, can safely undergo mri scanning, though the largest published study to date consists of 54 patients, and no long term follow-up has been published. though mri cardiac scanning has been demonstrated to produce local tissue heating at the pacemaker lead tip, the long term effect of tissue heating on lead stability is unclear. this study will evaluate patients with permanent pacemakers undergoing medically indicated mri scanning. patients will be followed for one year at 3, 6, and 12 months. data collected will evaluate change in pacing thresholds over time as well as cardiac troponin i, creatinine kinase mb function, and myoglobin levels within the first 12 hours following the scans, side effects, symptoms, the need to make pacemaker program changes, and possible artifacts created by the pacemaker on the mri scan.


Eligibility criteria:
inclusion criteria: * permanent pacemaker or icd implanted for at least 6 weeks * referred for medically indicated mri * age greater or equal to 18 years old exclusion criteria: * icd market released before 2001 including gdt ventak-av, gdt mini-ii, gdt mini-iv, gdt mini-iii, gdt prizm-2 mdt gem-i series * epicardial coronary sinus lead or subcutaneous array * unable to program all leads to bipolar configuration * pacemaker dependent * device has reached elective replacement or end of life * other usual contraindications to mri scanning * the use of inotropic pharmacological agents, such as dobutamine, during the mri

Keywords: pacemaker