Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of flacs with the femto ldv z8 laser compared to conventional cataract surgery in chinese patients

Conditions: Cataract

Summary: this trial will be designed as a multi-center randomized non-inferiority clinical trial to demonstrate safety and efficacy of the femto ldv z8 laser for cataract surgery in a chinese population in china compared to the conventional technique.

in this three center, prospective, interventional, randomized controlled study we aim to determine safety and efficacy of the femto ldv z8 laser as compared to conventional technique in chinese patients diagnosed with cataract of any severity grade that are eligible to undergo cataract surgery with age 50 years and a maximum age of 80 years in china.

Eligibility criteria:
inclusion criteria: * eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation * provision of signed and dated informed consent form * male or female, between 50 and 80 years of age (50 and 80 are included). * iol chosen for implantation a monofocal aspheric iol of 6mm optic diameter * willing to comply with all study procedures and able to return for scheduled follow-up examinations * willing to adhere to the medication (to prevent inflammation and infection) regimen exclusion criteria: * corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light * poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally (e.g., intraoperative floppy iris syndrome) * glaucoma or ocular hypertension, pseudoexfoliation * corneal endothelial pathology where endothelial cell count is compromised (fuchs endothelial dystrophy and others) * complicated cataract, such as traumatic, white, intumescent or posterior and anterior subcapsular cataracts * nystagmus or hemofacial spasm preventing placement of the patient interface * previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye * allergy to medications required in surgery, pre- and post-operative treatment * history of lens or zonular instability * keratoconus or keratectasia * immune compromised or diagnosis of ophthalmic disease: ocular herpes zoster or simplex, lupus, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study in the opinion of the study pi (principal investigator) * anterior chamber depth (acd) \ 4.8 mm as measured from the corneal endothelium. * developmental disability or cognitive impairment that would make informed consent and the assessment of visual acuity impossible * concurrent participation in another ophthalmological clinical study

Keywords: femto cataract surgery
echography-guided surfactant therapy (esther) for preterm infants with respiratory failure

Conditions: Respiratory Distress Syndrome, Newborn; Pulmonary Surfactants; Intensive Care Units, Neonatal

Summary: point-of-care ultrasound (pocus) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. pocus can be used to diagnose the severity of neonatal respiratory distress syndrome (rds) through a lung ultrasound score. lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. therefore, using lung ultrasound scores to guide surfactant therapy for rds will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. this study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with rds with our current surfactant administration guidelines.


Eligibility criteria:
inclusion criteria: * the infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study * birth gestational age between 27w0d-36w6d * diagnosis of respiratory failure secondary to rds requiring respiratory support with non-invasive positive pressure ventilation exclusion criteria: * unable to obtain lung ultrasound between 1-2 hours of life * infants already intubated or received surfactant before the point of care lung ultrasound * infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations * infants born with chromosomal abnormalities * infants with apgars ≤ 5 at 10 minutes of life * infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life
impact of home exercise delivery on compliance & outcomes for musculoskeletal pain

Conditions: Chronic Pain; Compliance, Patient; Chronic Low Back Pain; Knee Pain Chronic

Summary: patients seeking care for chronic low back or knee pain will be recruited for enrollment, and randomized within two phases (retention and compliance). patients will consent to a 2-step study design, with independent randomization for each. the initial step will assess retention based on 4 different exercise prescription strategies. this will be assessed short-term, and then the 2nd step will consist of a second independent randomization to receive different reminder strategies to determine their influence on exercise compliance at home.

patients seeking care for their chronic low back or knee pain will be recruited to participate in a trial investigating the value of different exercise and education prescription strategies as well as strategies to determine the influence of various exercise reminder strategies. on day 1 of enrollment, patients will be randomized and instructed in two different types and amounts of exercises, as well as two types of delivery strategies. the ability to recall and perform these exercises will be assessed 20 minutes after completion of the instructional period (retention). in phase 2, patients will be randomized to receive different reminder strategies (none, email, text, and/or video) and their compliance assessed over a 1 month period (compliance). self-reported compliance over the first month, and health care utilization outcomes will be analyzed for the 1 year following completion of the 1 month period, in all groups.

Eligibility criteria:
inclusion criteria: 1. the primary complaint of low back pain or knee pain and is not actively seeking care for their contralateral knee. 2. the current episode for the injury is 6 weeks or greater 3. a home exercise program is appropriate as part of the management plan for their injury on the first day 4. between the age of 18 and 65 years. 5. own and utilize a smart phone 6. read and speak english well enough to interact with the smart phone-based tool. 7. able and willing to come in for follow-up at 1-month. exclusion criteria: 1. history of prior surgery to the lower extremities or spine 2. already receiving or have received treatment for this episode of pain within the past 6 months. 3. medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, malignancy, joint infection, or systemic disease 4. if participating with low back pain, known current pregnancy or history of pregnancy in the last 6 months 5. exiting military health system in the next 2 months, pending litigation, or pending a medical separation board.
survival after failed first-line non-invasive ventilation in acute on chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Airways Disease Exacerbated; Critical Care

Summary: observational cohort study of mid-to-long term survival of patients with acute on chronic obstructive pulmonary disease, analyzed per type of ventilation support provided during first 24 hours in intensive care.

registry setting and procedures: the swedish intensive care registry (sir) collects a comprehensive dataset of patient characteristics, intensive care procedures and outcomes using detailed guidelines. continuous data are collected as raw data, validated locally and transferred electronically to the registry for central validation (confirmed to be within prespecified limits and inconsistencies and illogical entries identified). if necessary, data are returned for correction and revalidation before being accepted and added to the master database. study participants: patients with copd as the principal diagnosis during their icu stay were included in the study cohort. when patients had multiple admissions during the study period due to copd the last admission only was included. patients were excluded when nursing workload scores indicated active ventilation support during the first 24 hours but information on type of support (non-invasive or invasive ventilation) was lacking. participants with missing vital status were also excluded from analysis. patients were grouped according to the mode of the first-line ventilation support that was given during the initial 24 hours in icu. the standard therapy group did not receive any active ventilation support, the niv only group received non-invasive ventilation support only, the niv + invasive mechanical ventilation (imv) group received niv followed by intubation and invasive ventilation support and, the imv group were intubated and received invasive ventilation support without any preceding niv trial.

Eligibility criteria:
inclusion criteria: * principal diagnosis of icu stay: acute on chronic obstructive pulmonary disease exclusion criteria: * multiple admissions of patients during study period: every admission but the last one is excluded. * conflicting data on ventilation support * vital status missing at 6 months
antithrombotic drug use in patients with ischemic stroke and microbleeds

Conditions: Ischemic Stroke

Summary: to observe the effect of different antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds. and further combined with proteomic methods to explore serological markers that can be used to accurately predict the prognosis of such patients.

cerebral microbleeds (cmbs) are caused by microvascular lesions in the brain, which is a subclinical deposition of hemosiderin after the damage of microvascular. antithrombotic drug are widely used in the secondary prevention of patients with ischemic stroke. studies have shown that antithrombotic drug can increase the incidence of intracranial hemorrhage in ischemic stroke patients with cerebral microbleeds. for such patients, how to carry out effective and safe antithrombotic therapy is still unclear. we will study from two aspects: 1) we designed a cohort registration study to observe the prognosis and progress of cmbs in ischemic stroke patients one year after using various antithrombotic drugs. 2) data independent acquisition quantitative proteomics (dia quantitative proteomics) will be used to screen serum protein markers that may affect the prognosis of ischemic stroke patients with cmbs.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed clinically as ischemic stroke; 2. age ≥ 40 years; 3. onset time ≤ 3 months; 4. informed consent was signed. exclusion criteria: 1. patients with symptomatic intracranial hemorrhage; 2. bleeding lesion \> 10 mm was found on swi; 3. vascular malformations, tumors, abscesses or other major non ischemic brain diseases were present; 4. there are contraindications for antithrombotic drugs use; 5. serious systemic diseases; 6. refusal to sign informed consent or poor compliance.

Keywords: ischemic stroke microbleeds proteomics antithrombotic drug
catecholamine blockade post-burn

Conditions: Burns

Summary: severe burn is associated with a wide array of stress, metabolic, and physiologic processes in an attempt to restore homeostasis. the catecholamine induced stress response following severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin resistance, hypermetabolism, and associated profound protein catabolism. the investigators hypothesize that catecholamine blockade will lead to restored ir signaling and result in improved post-burn morbidity. the investigators will further determine the molecular mechanisms mediating these effects.


Eligibility criteria:
inclusion criteria: * patients between 18 and 90 years of age * \>25% tbsa burn exclusion criteria: * death upon admission * decision not to treat due to burn injury severity
assessing ketorolac (toradol) at oocyte retrieval

Conditions: Infertility; Infertility, Female; Oocyte Retrieval; Postoperative Pain; Embryo Transfer

Summary: to determine if a nonsteroidal anti-inflammatory drug (nsaid), ketorolac (toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.

postoperative pain control is an essential component to any surgical procedure. surgery represents a time during which opioid-naïve patients may be exposed to narcotics, risking opioid related complications and future opioid-use disorder. approximately 150,000 oocyte retrievals are performed per year in the united states, according to the 2017 assisted reproductive technology national summary report. a reduction in exposure to narcotics in this field has significant public health implications, particularly given that approximately 6% of new persistent opioid use occurs following minor surgical procedures. ketorolac (toradol) has been demonstrated to be a safe and efficacious agent to achieve pain control postoperatively with no significant increase in adverse events. the purpose of this prospective randomized blinded placebo controlled trial is to determine if a nonsteroidal anti-inflammatory drug (nsaid), ketorolac (toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval. approximately 400 women (n=200 in each arm) will be enrolled according to the inclusion/exclusion criteria among patients of shady grove fertility. participants will undergo a standard in vitro fertilization cycle (ivf) followed by egg retrieval (er). participants will be randomized to receive either iv ketorolac or iv placebo at the conclusion of the egg retrieval, administered by the anesthesia provider. all enrolled patients will receive standard post-operative pain management. the investigational component of this study lies in assessing post-operative pain control in the immediate post-operative period and in the post-operative period after discharge as reflected by pain scores and narcotic medication usage.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. females over 18 years of age who are scheduled to undergo oocyte retrieval 3. patients must be able to read and understand written english or have an appropriate certified medical translator available. 4. standard eligibility criteria to undergo ivf and embryo transfer at shady grove exclusion criteria: 1. known allergy to ketorolac 2. those with known medical conditions precluding them from ketorolac use (active peptic ulcer disease, recent or history of hemorrhage or perforation, known renal or hepatic insufficiency, suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, bleeding disorders, recent myocardial infarction, or stroke.) 3. bmi ≥ 40 kg/m2 4. history of substance abuse 5. chronic opioid use 6. transabdominal oocyte retrieval

Keywords: infertility, female in vitro fertilization ivf oocyte retrieval postoperative pain control nsaid ketorolac non-narcotic analgesia
a comparison of manual physical therapy and corticosteroid injections for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to compare an orthopaedic manual physical therapy (ompt) approach to a corticosteroid injection approach for the management of knee osteoarthritis.

the purpose of this study is to compare a commonly offered clinical approach of a series of intra-articular steroid injections to an orthopaedic manual physical therapy (ompt) approach consisting of manually applied passive movement and reinforcing exercise for the treatment of osteoarthritis of the knee (knee oa). a second purpose is to validate a clinical prediction rule (cpr) for patients unlikely to respond to the orthopaedic manual physical therapy approach in a pre-planned secondary analysis of data from the randomized clinical trial. aim 1: to see if there is a significant difference in pain and function lasting out to 1 year for patients that receive a clinical approach consisting of a series of intra-articular steroid injections compared to those that receive a clinical approach consisting of orthopaedic manual physical therapy. aim 2: to validate a clinical prediction rule of characteristics identified in a previous preliminary study that predicted which patients with knee oa would be unlikely to respond to ompt.

Eligibility criteria:
inclusion criteria: * all subjects must be eligible for care in the military health system * meet altman's clinical criteria for knee oa * have english language skills sufficient to complete the womac and groc outcome instruments * be 38 years of age or older exclusion criteria: * steroid injections or physical therapy treatment for their knee in the past 12 months * current or past history of rheumatoid arthritis or similar rheumatic condition * current or past history of gout or pseudogout of the knee * active infection in the knee within the past 12 months * other physical ailment or condition that is typically more limiting or painful than their knee oa during activities such as sitting, standing, walking, or stair climbing * history of allergy or adverse effect to corticosteroids * cannot speak/read english adequately to understand and provide consent to participate in the study * pregnant or intending to become pregnant * military service members pending a medical evaluation board, physical evaluation board, equivalent discharge process, or on medical hold to determine long-term disposition. for non-military personnel, anyone that is pending or undergoing any litigation for this condition. * contraindication to receiving a corticosteroid injection (history of allergic or adverse reaction to steroid injection, history of multiple corticosteroid injections in that area even if not within last year, etc) * unable to give informed consent to participate in the study.

Keywords: knee osteoarthritis physical therapy corticosteroid treatment
feasibility and acceptability of home-based stretching exercises in fibromyalgia

Conditions: Fibromyalgia; Pain; Quality of Life

Summary: the study aims to gather knowledge about the patient's acceptance of the intervention and testing procedures, assess the adherence to the intervention, estimate the recruitment rate, and inform the sample size calculation for a subsequent randomized controlled trial.


Eligibility criteria:
inclusion criteria: * patients are included if they are aged 18 to 55 years and diagnosed with fibromyalgia in accordance with the american college of rheumatology (acr) criteria exclusion criteria: * non-controlled systemic disorders * impaired alertness or comprehension * relevant joint disorders (e.g., severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis) * recent changes in therapy * neurological and musculoskeletal conditions that could compromise assessments
performance of endoscopic submucosal dissection according to the sedation method

Conditions: Early Gastric Cancer; Gastric Adenoma

Summary: although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on esd performance and complications have not been fully evaluated. in the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. however, there are several limitations to the study including retrospective design. the investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.


Eligibility criteria:
inclusion criteria: 1. age, between 20 and 80 2. early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection 3. ecog performance status 0 or 1 4. american society of anesthesiologist physical status 1, 2, or 3 exclusion criteria: 1. previous subtotal gastrectomy 2. previous gastrostomy 3. repeated endoscopic submucosal dissection 4. three or more synchronous lesions 5. allergy to midazolam, propofol, fentanyl, or remifentanil 6. pregnancy or breast milk feeding 7. active infection 8. significant cardiopulmonary disease 9. active hepatitis or severe hepatic dysfunction 10. severe renal dysfunction 11. severe bone marrow dysfunction 12. severe neurologic or psychotic disorder

Keywords: endoscopic submucosal dissection sedation propofol midazolam
long-term efficacy of percutaneous tibial nerve stimulation applied to patients with faecal incontinence.

Conditions: Faecal Incontinence

Summary: percutaneous tibial nerve stimulation (ptns) is an ambulatory therapy validated for patients with faecal incontinence (fi) refractory to conservative treatment with proved short and mid-term efficacy. the investigators therefore aimed to evaluate the long-term efficacy of ptns, considered 3 years of follow-up. the investigators also aimed to identify predictors of responses and suggest a new approach for partial responders.

prospective single-centre cohort of patients with fi treated with ptns was analysed. ptns sessions were performed in three phases: weekly for three months in the first phase, biweekly for three months in the second phase, and monthly for six months in the third and final phase. clinical control at the end of each phase and an additional follow-up was performed at 36 months. wexner score, faecal urgency, bowel habits and quality of life for fi were assessed. patients were categorized in three groups: optimal responders when there was an improvement in wexner score \> 50%; partial responders if the improvement in wexner score was 25-50%; and non-responders, when the improvement of wexner score was \< 25%. optimal responders and partial responders progressed into successive phases, whereas non-responders abandoned ptns and other treatment options were offered.

Eligibility criteria:
inclusion criteria: * diagnosis of faecal incontinence for more than 6 months, refractory to conservative treatment. exclusion criteria: * anatomic injuries that require surgery. * external anal sphincter lesion of \> 180º. * unavailability to attend regularly outpatient clinic. * major psychologic or psychiatric comorbidities

Keywords: percutaneous tibial nerve stimulation anal physiology faecal incontinence partial response long-term efficacy