Kornimate/medical-research-clean huggingface dataset:
penetrating trauma registry and open source data

Conditions: Penetrating Trauma Registry and Open Source Data

Summary: penetrating injuries comprise roughly 30% of methodist health system (mhs) trauma patients. firearm-related events have become more prevalent in the past few years. active shooter events, mass casualties, assaults, and homicide are more commonplace which leads to an increase of trauma patients needing management of penetrating injuries.

penetrating injuries comprise roughly 30% of methodist health system (mhs) trauma patients. firearm-related events have become more prevalent in the past few years . active shooter events, mass casualties, assaults, and homicide are more commonplace which leads to an increase of trauma patients needing management of penetrating injuries. on average, penetrating traumas only make up 14% of comparable center patient volumes. in spring 2022, we also were ranked 3/10 for our penetrating trauma outcomes with lower than expected mortality (tqip benchmarking report). together, as a level 1 trauma center with above average penetrating injury volume we must take efforts to best understand the opportunities for our patients and disseminate those observations to the trauma community

Eligibility criteria:
inclusion criteria: * • aged 16 years or older (national trauma data standard for adult) * penetrating injury or intent to cause penetrating injury exclusion criteria: * • aged 15 years or younger * prisoners, pregnant persons, or other protected population * not involved in penetrating trauma

Keywords: trauma
evolocumab for pcsk9 lowering in early acute sepsis (the please study)

Conditions: Sepsis

Summary: this study evaluates using evolocumab, a currently approved and marketed biologic drug, in a novel way. patients who present to the emergency room or intensive care unit (icu) with severe infection are eligible. either the patient or their designated decision maker will be approached for consent. if they choose to participate they will be given either a single dose of evolocumab, a higher single dose of evolocumab,or a single dose of placebo. participants will be followed during their stay in the icu and will receive follow up phone calls at day 28 and 90.

evolocumab is currently approved and marketed in usa and canada for lowering cholesterol levels. evolocumab is an anti-psck9 monoclonal antibody, and functions by binding psck9 (an inhibitor of ldl removal) and blocking its function. evidence suggests that since evolocumab increases the removal rate of low-density lipoproteins from the body, it might also help increase the removal of bacterial components that are attached to circulating lipids during sepsis. quickly removing these bacterial components could prevent a strong and rapid immune response that often leads to organ failure and death in sepsis patients.

Eligibility criteria:
inclusion criteria: * signed informed consent * at least 19 years of age * known or suspected infection * and one or more of the following organ dysfunctions judged due to sepsis: 1. cardiovascular- refractory hypotension (a systolic blood pressure (sbp) \ 90 mm hg or map \> 60 mm hg, or; 2. respiratory: pao2/fio2 \< 300 or pao2/fio2 \< 200 if lung is the only organ dysfunction or sao2:fio2 150 exclusion criteria: * known pregnancy * underlying severe congestive heart failure (new york heart association (nyha) iv), severe copd (need for chronic oxygen or mechanical ventilation), severe liver disease (child-pugh class c), cancer requiring chemotherapy, or transplantation (bone marrow, heart, lung, liver, pancreas, or small bowel) in the past 6 months or likely within the next 6 months * previous episode of sepsis during that hospital admission * absolute neutrophil count \< 500/mm³ * cd4 count \< 50/mm³ * treating physician deems aggressive care unsuitable (i.e. no commitment to active care) * participation in another interventional drug study within previous 1 month * allergic to the study drug or any of its components * lactation * have signed a do no resuscitate (dnr) form

Keywords: bacterial infection blood systemic icu
breathing exercises for labor pain and duration

Conditions: Labor Pain; Breathing Exercise

Summary: this study aimed to assess the efficacy of breathing exercises (be) during the second stage of labor for maternal pain, duration of labor and first-minute apgar score. this is a randomized controlled trial that compares nulliparous pregnant in the second stage of labor instructed regarding be with a control group (cg) that received standard care service. it was conducted at nenehatun obstetric and gynecology hospital between may-june 2016, in erzurum. one session of be training were given to pregnant in intervention group (ig). visual analog scale (vas) was performed to identify perception of pain to all pregnant during the second stage of birth. time of the second stage was recorded as second (sec), and first minute apgar scores were recorded. significance was set at p\<0.05.

in this trial, it is aimed to assess the effectiveness of breathing exercises (be) for management of labor pain during the second stage of labor. nulliparous pregnant were randomized two arms. intervention group received breathing exercise at the first stage of labor. control group received routine care services. it was conducted at nenehatun obstetric and gynecology hospital between may-june 2016, in erzurum, turkey. visual analog scale (vas) was performed to identify perception of pain to all pregnant during the second stage of labor. time of the second stage was recorded as second (sec), and first minute apgar scores of newborn were recorded. all analysis was carried out using spss 20. significance was set at p\<0.05.

Eligibility criteria:
inclusion criteria: * nullipar females * gestational age 37-42 week exclusion criteria: * analgesic and anestezice use * clinical instability * psychiatric disorders

Keywords: breath exercises labor pain labor duration vas
a study to evaluate the safety of allo-asc-dfu in the subjects with deep second-degree burn wound

Conditions: Burn

Summary: this is a phase i study to evaluate the safety of allo-asc-dfu for the treatment of deep second-degree burn wound patients. allo-asc-dfu is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells release growth factors such as vascular endothelial growth factor (vegf) and hepatocyte growth factor (hgf), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age and older. 2. subjects who have deep second-degree burn ≥100 cm\^2. 3. negative for urine beta-hcg for women of childbearing age. 4. subject is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. subjects who have been enrolled in another clinical study within 30 days of screening. 2. subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue. 3. subjects who are receiving steroids, immunosuppressive, or anticoagulant. 4. subjects with active infection. 5. subjects with hemorrhagic and hemocoagulative disease 6. subjects who are unwilling to use an "effective" method of contraception during the study. 7. subjects who have a history of malignant tumor within the last five years, or is currently undergoing. 8. subjects who are pregnant or breast-feeding. 9. subjects who are considered to have a significant disease which can impact the study by the investigator 10. burn wound is present on any part of the face. 11. subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site). 12. subjects who are considered not suitable for the study by the investigator. 13. subjects who are not able to understand the objective of this study or to comply with the study requirements.

Keywords: deep second-degree burn wound
a study of tl-925 ophthalmic emulsion as a treatment for dry eye disease

Conditions: Dry Eye Disease

Summary: in this prospective, phase 2b, multicenter, randomized, double-masked, vehicle-controlled, parallel-arm study, approximately 880 subjects with moderate to severe dry eye disease (ded) will be randomly assigned (1:1) to receive either tl-925 or vehicle as topical ophthalmic eye drops administered bilaterally bid. the study will comprise two phases: a two-week screening phase/run-in and a six-week double-masked treatment phase.


Eligibility criteria:
inclusion criteria: * a diagnosis of dry eye disease for at least 6 months * an unanesthetized schirmer's test score (sts) of ≤ 10mm and ≥ 1mm in the study eye * female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study exclusion criteria: * any clinically significant slit lamp finding * any ongoing ocular infection (bacterial, viral or fungal) or active ocular inflammation * best-corrected visual acuity ≥0.7 logarithm of the minimum angle of resolution * any keratorefractive surgery within the last 12 months * any intraocular or extraocular surgery within 3 months * any blepharoplasty or corneal transplant in either eye * any form of punctual, or intracanalicular occlusion in either eye * history or presence of any ocular disorder that may interfere with study results
extension for menopause sample collection

Conditions: Menopause

Summary: this study will provide urine samples from women going through the menopause transition in order to maintain the spd sample bank. symptom information and cycle length will also be recorded to observe how these change through the menopause transition.

this is an extension to a previous sample collection (protocol-1326) where additional samples will be collected from the women who continue to go through the menopausal transition (i.e. are not post-menopausal). three sets of 10 consecutive daily urine samples will be collected at three timepoints (month 0, month 6 and month 12). urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚c until required.

Eligibility criteria:
inclusion criteria: * pre- and peri-menopausal volunteers(assigned by straw+10 criteria) who completed protocol-1326 exclusion criteria: * post-menopausal volunteers (12 months since last menstrual period) * use of hormone replacement therapy (hrt) * use of hormone contraception * hysterectomy and/or oophorectomy * pregnant or breast feeding * other medical reason for amenorrhea (absence of menstruation)
mohs micrographic surgery and reconstruction in the optum insurance claims database

Conditions: Skin Cancer; Mohs Micrographic Surgery; Interpolated Flap Repair

Summary: mohs micrographic surgery (mms) followed by skin reconstruction has been widely accepted for treatment of many skin cancers. to further characterize the trends in mms and reconstruction for skin cancer, a retrospective analysis will be performed using the optum© clinformatics® datamart de-identified commercial claims database from 2001-2016. the findings may provide critical data for future prospective studies in skin cancer treatments.


Eligibility criteria:
inclusion criteria: - all patients in the optum© clinformatics® database who have an icd9 or icd10 code for skin cancer and a corresponding cpt code specific for interpolated flap reconstruction exclusion criteria: - all patients for whom cost data is missing in the optum© clinformatics® datamart
tyvaso dosing and titration evaluation: tytrate registry

Conditions: Pulmonary Arterial Hypertension

Summary: this prospective, observational, multi-center, patient registry will follow patients who are newly initiated on tyvaso for the treatment of pulmonary arterial hypertension (pah). once enrolled, the patients' dose and titration will be followed for the first 6 months of treatment with tyvaso. a call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 to review their dose and titration schedule. in addition to patient-reported dosing data, some patient demographic information, will be collected by the investigative site at baseline.


Eligibility criteria:
inclusion criteria: * are newly prescribed tyvaso for the treatment of pah and plan to initiate therapy * are willing and able to be contacted by the patient call center. exclusion criteria: * have previously received tyvaso. * are currently enrolled in an interventional (non-fda approved) ph clinical trial.

Keywords: tyvaso pah
comparison of efficacy of cefotaxime, ceftriaxone, and ciprofloxacin for the treatment of sbp in patients with lc

Conditions: SBP; Liver Cirrhosis

Summary: spontaneous bacterial peritonitis (sbp) is one of the most serious complications of liver cirrhosis. mainstay of treatment for sbp is use of proper antibiotics. although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. our aim of study is to compare the efficacy of the three current antibiotics for the treatment of sbp in patients with liver cirrhosis. the primary hypothesis is that the efficacy of all the antibiotics will not significantly different. this is non-inferiority trial.

spontaneous bacterial peritonitis (sbp) is one of the most serious complications of liver cirrhosis. mainstay of treatment for sbp is use of proper antibiotics. although, several antibiotics including cefotaxime, ceftriaxone, or ciprofloxacin are being used, it is unclear which drug is most effective. our aim of study is to compare the efficacy of the three current antibiotics for the treatment of sbp in patients with liver cirrhosis. the primary hypothesis is that the efficacy of all the antibiotics will not significantly different. the expected success rates (infection resolution rates) are 83%, 87%, and 78% for cefotaxime, ceftriaxone, and ciprofloxacin. this is non-inferiority trial. the level of significance is 5%. the power of this stuy is 80%. non-inferiority margin is 15%. therefore 87 patients for each group are needed.

Eligibility criteria:
inclusion criteria: 1. liver cirrhosis patients with ascites 2. ascitic fluid pmn cell count \>250/mm3 3. age: 16\~70 years old exclusion criteria: 1. allergic to 3rd generation cephalosporin or quinolone 2. antibiotics within 2 weeks 3. open abdominal surgery within 4 weeks 4. evidence of 2ndary peritonitis, intrabdominal hemorrhage, pancreatitis, tb peritonitis, or peritoneal carcinomatosis 5. hcc with portal vein thrombosis 6. pregnant woman 7. hiv positive

Keywords: sbp liver cirrhosis antibiotics
a post-marketing surveillance study to assess safety of ozanimod in patients with moderate to severe active uc in korea

Conditions: Ulcerative Colitis

Summary: the purpose of this observational study is to assess the real-world safety of ozanimod in korean participants with moderate to severe active ulcerative colitis.


Eligibility criteria:
inclusion criteria: * adult participants 19 years of age or older * participants who will receive ozanimod according to the approved label after enrollment * participants who sign the informed consent form voluntarily exclusion criteria: * participants who are prescribed ozanimod for therapeutic indications not approved in korea * participants for whom ozanimod is contraindicated as clarified in korean prescribing information approved by ministry of food and drug safety
managing type 1 and high risk type 2 diabetes in the hospital setting: glucose as a vital sign

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this program will provide patients with type 1 and high risk type 2 diabetes the safest hospitalization by using wireless continuous glucose monitoring devices (cgm) to track their glucose parameters in real-time similar to other continuously monitored vital signs. the cgm will inform a team of health professionals who will monitor the patients' progress, communicate recommendations, and be available for discussion when recommended targets are not achieved. health teams will utilize sensor results in addition to existing electronic medical records data to evaluate progress and manage care.

all patients with type 1 or type 2 diabetes who meet study criteria will be invited to participate in the study. all patients included in the study will be followed by an advanced practice diabetes nurse for glucose management during their hospitalization. all patients included in the study will receive a cgm. patients with type 2 diabetes will be randomized to control (blinded cgm glucose values to apn, care team and researchers) or intervention (cgm blood glucose values will be used to aid with glucose management during the hospitalization). in addition, a research only supplemental order set will be implemented for all study participants. the order set focuses on any glucose point of care test that is between 70-79 mg/dl or ≥ 250 at bedtime or before the 4 am usual care blood glucose check. the goal is to prevent hypoglycemia and hyperglycemia for all study patients. the advanced practice diabetes nurse will work with the physician in charge of the patient's care as well as the patient's care team.

Eligibility criteria:
inclusion criteria: * expected length of hospital stay of at least 48 hours * one of the following: 1. diagnosed with diabetes type 1 or 2. diagnosed with diabetes type 2, with an hba1c \> 8% or 3 point-of-care blood glucose (poc) \> 200, and requiring insulin during this hospitalization. * literate in english or spanish exclusion criteria (not all listed): * pregnant or post-partum * patient admitted to ob unit * patient in icu or with insulin drip * known allergy to adhesives * anticipated ct/mri/diathermy procedure within 48 hours from admission (patients with a planned operation within 48 hours from admission may be included in the study post operation).

Keywords: hospitalization
effects of fun physical activity on the interest to daily physical activity and sarcopenia of elderly people

Conditions: Activity

Summary: in this research, the elderly living in nursing homes were selected in two group control and intervention. intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).

have of a healthy life with minimal complications in this period. most important issue in improving the health and quality of life of the elderly is maintain their independence in physical activity. world health organization (who) is believed that, the first indicator of the health of a society is physical activity of the society. the studies show that sarcopenia leads to a decrease in the function and increase of disability 2/1 male and 3/1 are older women. sarcopenia leads to some perturbation such as, movement disorders, impaired balance, the incidence of inflammatory disease and dementia. in this reserch, the elderly living in nursing homes were selected in two group control and intervention. intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises. (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc).

Eligibility criteria:
inclusion criteria: * age more than 60 year exclusion criteria: * absence more than 3 session training
silica gel fiber wound dressing for chronic venous leg ulcers

Conditions: Venous Ulcer

Summary: silica gel fiber is a bioresorbable, inorganic silica gel fibre patch promoting skin tissue growth and enhanced wound healing for all types of chronic wounds. it is applied as patch and will be hold in place by a secondary dressing for maintaining the moist wound environment. the study is aimed to demonstrate superiority over a standard wound treatment for chronic venous leg ulcers. the primary efficacy variable is time to healing.


Eligibility criteria:
inclusion criteria: * at least one chronic venous leg ulcer fulfilling all of the following criteria: * size: \>/= 5 cm2 and \</= 40 cm2 (measured by visitrak wound measurement system) * duration: \>/= 3 month \< 5 years * location: between and including knee and ankle * depth: involving dermis, with no exposed muscle, tendon or bone. characterized by a viable wound bed with granulation tissue * the etiology of the ulcer as "venous" is proven by duplex or doppler sonography and with ankle/brachial arterial doppler pressure index \> 0.8 (exclusion criterion for peripheral arterial disease) and \ 40 * treatment with active wound care agents paused for 14 days before start of study treatment exclusion criteria: * only ulcers of other than venous etiology, e.g., diabetic ulcers or ulcers resulting from electrical, chemical, or radiation insult, after contact eczema, etc. * history of radiotherapy to the target ulcer site * signs of infection as defined by rubor, dolor, calor, tumor, functio laesa. fever (38°c sublingual, rectal, or ear), rigors, or leukocytosis will be considered as signs of infection in the context of the general appearance of the wound * target ulcer lacking any sign of granulation tissue (bradytrophic wound bed) * presence of necrotic tissue * presence of fistula * history of connective tissue disease, e.g., systemic lupus erythematodes, systemic sclerosis, sjögren's syndrome or mixed connective tissue disease * uncontrolled congestive heart failure * malnutrition (albumin \< 2.5 g/dl; to be measured if clinical signs of malnutrition are being observed) * uncontrolled diabetes (hba1c \> 8 %) * previous organ transplantation * active malignant disease * severe rheumatoid arthritis * undergoing haemodialysis * active sickle cell disease * patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes * pregnant or nursing women * woman of childbearing potential who are not practicing acceptable methods of birth control during the investigation period * known allergy to any of the devices' constituents

Keywords: silica gel fiber chronic venous leg ulcers venous ulcer stasis ulcer varicose ulcer