Kornimate/medical-research-clean huggingface dataset:
pressure injury、caregiver、knowledge translation

Conditions: Pressure Injury; Pressure Ulcer

Summary: background and importance: in 2003, a pressure injury is listed as one of the indicators of care quality in clinical setting by taiwan joint commission on hospital accreditation. that reflects that a pressure injury is a significant heath care issue. nowadays, it still constantly happens at hospitals, home, and nursing homes: pressure injuries cause pain, and increase length of hospital stay, rehospitalization rate, and death rate. in current clinical practice, standardized guidelines and basic principles are followed for pressure injury management, and it is found that most of the caregivers are unsure about what are the consequences of having pressure injuries and how to manage and prevent them. therefore, the caregivers are more passive, and feel nervous and confused. in literature, there are guidelines for pressure injury prevention and management. however, they are primarily designed for heath professionals. as a result, to achieve evidence-based practice and knowledge translation, i hope to make individual management plans for each patient, provide caring support, and follow up with patients. and caregivers can benefit from knowledge, attitude, practice, and caring effect.

goals: the study aims to achieve knowledge translation in nursing for pressure injury care. the caregivers of patients with pressure injuries and their family can benefit from translating of knowledge, attitude, and practice, and they can have more knowledge related to pressure injuries, and learn how to react to and care for patients. in this way, it will be possible to promote wound healing and prevent recurrence of pressure injuries. method: this study is a randomized controlled trial. there are seventy participants. the experimental group receives care plans in which knowledge translation is applied, and the control group receives usual care. generalized estimating equations, gee, is used to assess the effectiveness of care plans with knowledge translation for patients and family with pressure injuries.

Eligibility criteria:
inclusion criteria: 1. grade 1-3 pressure injury diagnosed by medical staff. 2. the patient needs to have a caregiver. 3. the patient and the caregiver need to be older than 20 years old, (4) the informed consent of this study. (5) the caregiver those who understand the content of health education (mmse\>24 points) exclusion criteria: 1. the patient has \>3 disease diagnoses, 2. the patient is diagnosed by a doctor as a terminally ill patient or the life expectancy is less than 3 months, 3. there is a life-threatening acute problem (active bleeding site, acute myocardial infarction, acute bronchitis, etc. ), 4. pressure injury caused by invasive pipeline placement, 5. need to wear non-invasive positive pressure respirator, (6) need to stay in intensive care center for a long time (\>10 days), 6. need a long time for surgical patients, each operation takes \> 5 hours, 7. the caregiver has dementia, 8. the caregiver has mental illness or alcohol and drug addiction, 9. no caregiver.

Keywords: caregiver nursing plan
pilot study of a 14-day modified sequential therapy for helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: the purpose of this study is to assess efficacy of a 14-day sequential therapy for the rescue treatment of refractory helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

half of the world's population is infected with helicobacter pylori. strong evidence supports that h.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. however, eradication rates of first-line therapy decreased over years due to the rapidly emerging antibiotic resistance of h. pylori worldwide. an ideal rescue therapeutic regimen to cure refractory h.pylori infection is currently warranted. traditional sequential therapy failed to achieve an ideal eradication rates (over\>95%) as a third line treatment in the region with high antibiotic resistance. the investigator's study aims to evaluate the efficacy 14-day modified sequential therapy in the patients with two or more treatment failure, and whether the adverse effects of this new modified sequential therapy are tolerable.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with persistent h. pylori infection. * patients failed at least three different standard eradication therapies before. previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to maastricht v report. exclusion criteria: * patients unable or unwilling to receive gastroscopy. * patients treated with h2-receptor antagonist, ppi, bismuth and antibiotics in the previous 4 weeks. * patients with gastorectomy, acute gi bleeding and advanced gastric cancer. * history of allergy to any of the drugs used in the study. * severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk. * currently pregnant or lactating. * severe neurologic or psychiatric disorders. * alcohol abuse or drug addiction. * patients with compliance lower than 90% in any previous treatment are not included. * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Keywords: sequential therapy rescue treatment
effectiveness and safety trial of a new ischemic stroke treatment within 24 hours from stroke onset (nest-2)

Conditions: Ischemic Stroke

Summary: the purpose of this pivotal study is to demonstrate safety and effectiveness of the neurothera® laser system (referred to hereafter as nts) in the treatment of subjects diagnosed with acute ischemic stroke. the initiation of nts treatment must be feasible for each subject within 24 hours of stroke onset.

this study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 subjects. subjects will be followed for 90 days post stroke onset. the primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified rankin scale (mrs) score of 0-2 and failure as an mrs score of 3-6 at 90 days or the last rating. the secondary effectiveness endpoint for this study will be the change in nihss score from baseline to 90 days or the last rating, analyzed across the full range of scores on the nihss. tertiary effectiveness endpoints include: the 90-day binary endpoint, denoted as the 90-day bnih score, based on the nihss score that defines a successful result as either (i) an improvement of 9 or more points on the nihss or (ii) a final nihss score of 0 or 1; the score on the mrs at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mrs scale, sis-16 at 90 days; mortality at 30, 60 and 90 days.

Eligibility criteria:
inclusion criteria: 1. diagnosis of acute ischemic stroke within 24 hours 2. clinical diagnosis of acute ischemic stroke after exclusion of hemorrhage by a ct scan or susceptibility weighted mri sequences 3. nihss ≥7 - ≤22 exclusion criteria: 1. \>24hours from symptom onset to time of treatment 2. evidence of intracranial, subdural, or subarachnoid hemorrhage 3. clinical presentation of intracranial hemorrhage 4. pre stroke ≥3 mrs 5. the presence of a brainstem or cerebellar stroke 6. transient ischemic attack (tia) 7. seizure at stroke onset 8. blood glucose \>400 or \<60 9. sustained systolic bp \>220mmhg \ 140mmhg \<50mmhg 10. septic embolus 11. cns tumor (except asymptomatic meningioma) 12. dermatologic condition of the scalp (e.g. psoriasis) 13. thrombolytic therapy 14. head implant (e.g. clipped aneurysm, hakim valve)

Keywords: acute stroke infrared laser therapy clinical trial safety effectiveness
safety/efficacy study of retigabine vs. placebo in post-herpetic neuralgia (phn)

Conditions: Postherpetic Neuralgia

Summary: the purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing pain associated with post-herpetic neuralgia.

this is a phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs. placebo in patients with post-herpetic neuralgia. after screening, patients will enter a maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper phase.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent * male or female subjects * 18-85 years of age * phn for more than 6 months after the healing of herpes zoster skin rash * has a pain score at screening and randomization that qualifies exclusion criteria: * other significant pain that may potentially confound phn pain assessment * previous neurolytic or neurosurgical therapy for phn * subject has evidence of a progressive central nervous system (cns) disease (e.g. cns lupus, tumors, multiple sclerosis, alzheimer's), lesion, or encephalopathy * significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or recent history of suicidal ideation * has clinically significant abnormalities on physical examination, vital signs, ecg, or laboratory tests at the screening visit

Keywords: postherpetic neuralgia, phn, shingles,
angiogenesis in early breast cancer for prognosis prediction

Conditions: Breast Lesions

Summary: this study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.


Eligibility criteria:
inclusion criteria: * patient with a breast mass highly suspicious for malignancy from clinical, mammographic or sonographic examination. * the study has been explained to the patient when she is scheduled for surgery. * healthy normal volunteers for imaging protocol optimization. exclusion criteria: * pregnancy * patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material, * patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities, * patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion, * patients with implanted prosthetic heart valves, * patients with pacemakers, neuro-stimulation devices, * a breast mass with features of benign tumor * the patients unwilling to participate in the study or fail to sign the consent form
biosimilar versus urinary gonadotropins

Conditions: Infertility

Summary: biosimilar drug marketing of recombinant fsh for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant fsh stimulation protocol vs. urinary fsh in oocyte donation program.

biosimilar products are drugs "like" biotechnological origin to other innovative biological medicines and that can be marketed once the patent has expired. these drugs are intended to achieve the same therapeutic benefit as biological medicinal resembles. because of the similarity in both the active substance in the formulation, it is intended to demonstrate the equivalence between the biosimilar medicine of recombinant fsh and fsh of urinary origin in terms of fitness. the investigators' main objective is to perform a non-inferiority trial of biosimilar recombinant fsh product compared to a conventional ovarian stimulation protocol with urinary fsh in relation to the number of oocytes retrieved and the number of metaphase ii oocytes.

Eligibility criteria:
inclusion criteria: * patients aged 18-35 years who meet the criteria for entry into the oocyte donor program and that are going to undergo controlled ovarian stimulation exclusion criteria: * patient with a basal antral count\> 20 follicles in total or \<6 antral follicles per ovary * patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation * the presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor * bmi \<18 kg / m2 * bmi\> 30 kg / m2 * severe hypersensitivity to drugs with similar structure

Keywords: biosimilar ovarian stimulation oocyte donor
the effects of vegf-b signaling pathway in obesity and metabolic disease

Conditions: Obesity; Metabolic Disease

Summary: the investigators will enroll about 120 subjects from the hospital's healthcare center. the investigators will collect the basic informations, blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject. the investigators will collect the blood samples and then test them for fasting insulin levels, vegf-b levels, the gene promoter region methylation status and the genomic protein methylation levels of the vegf-b gene of the cells，and finally do the statistical analysis.

the investigators will enroll about 120 subjects from the hospital's healthcare center, and these 120 subjects will be divided into four groups: normal weight with or without metabolic diseases and obesity with or without metabolic diseases. each group has 30 subjects. the investigators will collect the basic information(name, gender，age, medical history，family history, etc.), blood pressure, body mass index, fasting blood glucose and fasting blood lipids of each subject from the healthcare center. the investigators will collect the blood samples of each subject,separate the plasma and then test the fasting insulin, vegf-b levels by elisa. the investigators will separate the peripheral blood mononuclear cells from the blood, and then test the gene promoter region methylation status of the vegf -b gene by pcr and the bisulfite-modified sequencing and test the genomic protein methylation level of the vegf-b gene by chromatin immunoprecipitation assay(chip) and real-time quantitative pcr of the cells，and finally do the statistical analysis.

Eligibility criteria:
inclusion criteria: * na exclusion criteria: * subjects with active history insulin treatment; and female participant pregnant at the time of recruitment.

Keywords: vegf-b
efficacy of dengue infection with warning signs treated with dexamethasone (dengdex study)

Conditions: Severe Dengue

Summary: the goal of this randomized double-blinded placebo-controlled trial is to learn about dexamethasone and the treatment of severe dengue population. the main question it aims to answer are steroid therapy may be effective in dengue.


Eligibility criteria:
inclusion criteria: * laboratory confirmed dengue infected patients (positive ns1 ag or anti-denv igm by dengue duo test) * and still in febrile phase (body temp\>37.5 c) * shock : sys\ 100/min) with hematocrit decreased ≥20 % * fluid accumulation and respiratory distress * severe bleeding * severe organ involvement exclusion criteria: * severe dengue\> 24 hrs * dengue without warning signs * pregnancy * patient who receieved any steroid within 1 week

Keywords: severe dengue dexamethasone steroid
continuous infusion of local anesthetic for optimal post operative pain control following hemorrhoidectomy

Conditions: Hemorrhoids

Summary: over the past decade, continuous wound infiltration systems have been introduced to treat a variety of post-surgical pain. these systems, commonly referred to pain pumps by patients, possess a catheter(s) attached to a reservoir of local anesthetic that directly infuses into the surgical site to provide local pain control thus avoiding the common and less desirable systemic effects of oral narcotic pain medication. due to its portability, another benefit associated with these wound infiltration systems is its use as an outpatient pain control modality. despite the apparent benefits, the verdict on the system's effectiveness in treating pain - throughout a variety of surgical fields - varies between very effective in reducing post-operative pain and reducing overall narcotic consumption for several days to completely ineffective with no reported changes in perceived pain or overall narcotic use. through a randomized trial comparing plain saline to a common local anesthetic, the investigators hope to evaluate the effectiveness of these pain pumps as an outpatient modality for pain management following hemorrhoidectomy patients. the investigators hypothesize that there will be a significant benefit in pain relief with the use of these pumps.


Eligibility criteria:
inclusion criteria: * patients scheduled for hemorrhoidectomies at nmcp exclusion criteria: * any patient with co-existing active purulent infection (i.e. abscess). * any patient who has had previous surgical intervention for his/her hemorrhoidal disease. previous simple incision to treat a thrombosed hemorrhoid is not considered a surgical intervention for the purposes of this study. the minimal scar produced by a small incision would not alter post-operative pain following removal of a hemorrhoidal column. * any patient allergic to local anesthetics or oral pain medications * any patient with a history of chronic pain * any patient allergic to or has had an adverse reaction (i.e. history of gastrointestinal bleed) to a non-steroidal anti-inflammatory drugs (nsaids) * any patient pregnant patient

Keywords: hemorrhoidectomy pain management
anticoagulation with enhanced gastrointestinal safety (aegis) trial

Conditions: Upper Gastrointestinal Bleeding

Summary: this is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the michigan medicine anticoagulation monitoring service.

in february 2022, the irb approved adding a small additional substudy for the collection of exploratory qualitative outcomes only, involving up to 8 primary care physicians. as no data for the primary and secondary outcome measures was collected for this substudy, and all data collection for this group was related to exploratory outcome measures and collected through qualitative interviews with clinicians, no inclusion exclusion criteria specific to the participants in this substudy are listed, nor does the data collection from them show in the study completion date or results data. however, these physicians (n=8) and their patients (n=9) are counted in the actual enrollment total since they were randomized to intervention arms and received study interventions.

Eligibility criteria:
inclusion criteria for patients: * enrollment with the michigan medicine anticoagulation monitoring service * currently prescribed warfarin with anticipated use for greater or equal to 90 days on day 1 of trial enrollment, according to electronic medical record documentation * currently prescribed an antiplatelet drug (aspirin, clopidogrel, ticagrelor, or prasugrel) according to the electronic medical record medication list exclusion criteria for patients: * prescribed a proton pump inhibitor (ppi) * documented intolerance or allergy to ppi use * left ventricular assist device * heart transplant inclusion criteria for clinicians: * practicing cardiologists at michigan medicine who in the prior year had a face-to-face or virtual visit with a patient who meets eligibility criteria for this study * practicing clinicians in any specialty who are designated as the clinician of record with the anticoagulation clinic for a patient who meets eligibility criteria exclusion criteria for clinicians: - cardiologists specializing in electrophysiology unless they are the clinician of record for a patient followed by the anticoagulation service.

Keywords: combination antithrombotic therapy proton pump inhibitor peptic ulcer disease gastroprotection warfarin anticoagulation patient safety
quantitative xylazine measurement in ed

Conditions: Opioid Overdose; Substance Use Disorders

Summary: quantitative xylazine measurement among non-fatal opioid overdose (od) patients in the emergency department (ed)

xylazine, a veterinary medication and alpha-2 agonist drug with clinical effects including prolonged sedation and skin/soft tissue wounds, has been increasingly detected with fentanyl in the illicit opioid supply. due to its rapid emergence, limited knowledge exists regarding xylazine's health effects. in this proposed research, dr. love will measure xylazine and its metabolites in blood and urine samples using laboratory and point-of-care assays. working at two new york city emergency departments, dr. love will collect waste serum and urine from opioid overdose patients to measure xylazine and its metabolite concentrations. the researcher will also perform qualitative assessment of urine samples with xylazine test strips to characterize urine xylazine detection using a harm reduction tool.

Eligibility criteria:
inclusion criteria: * ed patient * opioid od (both nps and non-nps) * availability of waste blood specimens for analysis * availability of waste urine specimens for analysis exclusion criteria: - children under 18

Keywords: opioid xylazine substance use
evaluation study of a mouthwash based on schinus terebinthifolius to treat gingivitis in children

Conditions: Gingivitis; Plaque Accumulation

Summary: the purpose of this study is to evaluate the clinical efficacy of a mouthwash based on a natural product (schinus terebinthifolius) used by children with gingivitis.


Eligibility criteria:
inclusion criteria: * age group: 10-12 years old * presence of at least 20 dental elements * do not use orthodontic fixed appliances * simplified oral hygiene index (s-ohi) is greater than 2 * levels of microbiological streptococcus mutans in saliva high (\> 10,000 cfu / ml) (jensen; bratthall, 1989) * susceptibility to form biofilm and gingival inflammation * absence of systemic disease * not be under the use of antiseptic mouthwash in the last 3 months exclusion criteria: -

Keywords: gingivitis schinus terebinthifolius natural products