Kornimate/medical-research-clean huggingface dataset:
a study of artificial intelligence assisted small incision lenticule extraction (smile) for surgical design and influencing factors

Conditions: Myopia; Myopic Astigmatism

Summary: the goal of this observational study is to learn about the difference of refractive outcomes between artificial intelligence and experienced surgeon predicting nomogram assist smile surgical design and the influenced factors of refractive outcomes in patients who underwent small incision lenticule extraction(smile) at the refractive surgery center of tianjin eye hospital. the main questions it aims to answer are: * compare the difference of refractive outcomes between artificial intelligence and experienced surgeon predicting nomogram assist smile surgical design * analysis the influenced factors of refractive outcomes

in this ambispective observation study, to compare the difference of refractive outcomes between artificial intelligence and experienced surgeon predicting nomogram assist smile surgical design and analysis the influenced factors of refractive outcomes, patients have been continuously recruited and the data can then be used for further case-control and cohort studies.

Eligibility criteria:
inclusion criteria: * age of 18 years and older * stable refraction over the past 2 years * corrected distance visual acuity (cdva) of 20/25 or better * soft contact lens discontinued 2 weeks or longer * rigid contact lens discontinued 4 weeks or longer exclusion criteria: * abnormal corneal topographic features * severe dry eye * active keratitis * corneal scars * keratoconus or suspected keratoconus, * glaucoma * retina diseases * history of intraocular or corneal surgery * pregnant or lactating women, required chronic systemic corticosteroids or immunocompromised subjects were also excluded from this study

Keywords: small-incision lenticule extraction artificial intelligence nomogram refractive surgery myopia correction
comparison of a taurolock™ based regimen to 4% citrate as lock solution in tunneled haemodialysis catheters for the prevention of bacteraemia and dysfunction

Conditions: Catheter Infections; End-stage Renal Disease

Summary: catheter infections and dysfunctions are a major cause of morbidity and mortality in haemodialysis patients. according to the us renal data system, infection is the second leading cause of death in dialysis patients and the leading cause of catheter removal and morbidity in patients with end-stage renal disease. there is evidence that catheter lock solutions containing taurolidine reduce the risk of catheter related infections and improve catheter patency. lock solutions have a local, but no systemic effect. in this study a taurolidine based lock regimen (taurolock™-hep500, tauropharm, waldbüttelbrunn, germany, 2x/week and taurolock™-u25.000, tauropharm, waldbüttelbrunn, germany, 1x/ week) will be compared to 4% citrate (citraflow™ 4%, medxl, montreal, canada, 3x/week) as standard lock solution. the objective of this study is to evaluate if a taurolock™ based regimen to lock tunneled haemodialysis catheters has reducing effects on catheter related blood stream infections and catheter dysfunctions.


Eligibility criteria:
inclusion criteria: * adult patients aged greater than 18 years. * written informed consent. * requirement for haemodialysis using a tunneled dialysis catheter. exclusion criteria: * children aged less than 18 years. * positive blood culture in previous seven days before catheter insertion. * heparin induced thrombocytopenia and any contraindication for anticoagulation (recent or planned surgery, thrombocytopenia \< 70g/l, bleeding disorder).

Keywords: catheter dysfunctions blood stream infections haemodialysis taurolidine tunneled
synovial tissue and blood signature of rheumatoid arthritis patients with disease flare after treatment discontinuation for sustained remission.

Conditions: Rheumatoid Arthritis

Summary: flares of immune-mediated inflammatory diseases, as rheumatoid arthritis (ra), are a major burden for patients in routine care. they occur unpredictably, adding to the physical and psychological burden of the condition. in this study we will deeply dissect the synovial tissue and peripheral blood signature of ra in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. we expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in ra in remission, will provide a tool for the routine assessment of ra eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.


Eligibility criteria:
inclusion criteria: * diagnosis of ra following the 2010 acr/eular classification criteria * age ≥18 and ≤75 years * sustained remission (das\<1.6 for at least 3 sequential evaluations 6months apart). * without evidence of ultrasound detected synovitis (power doppler negative in knee, wrist, ii-v mcp, ii-v pip and ii-v mtp bilaterally). * patients under treatment with stable dose of conventional, synthetic or biological dmards. * patients without steroid treatment in the last 6 months. exclusion criteria: * with other diagnosis of chronic joint diseases rather than ra. * unable to participate to the clinical outpatient follow-up. * exposed to steroid treatment within 6 months from study screening. * with evidence of ultrasound detected synovitis (power doppler positivity) in other joints than the ones included in the screening visit.

Keywords: synovial tissue disease flare sustained remission peripheral blood
an open-label, exploratory trial to assess gastric acid control in critically ill subjects receiving nexium

Conditions: Gastric Ulcer

Summary: this study is being done to see if nexium i.v. can reduce and control stomach acid in mechanically ventilated, critically ill patients in an intensive care unit setting.


Eligibility criteria:
inclusion criteria: * critically ill male or female subjects 18 years or older who have a baseline gastric aspirate ph less then or equal to 4 * subjects admitted to an icu requiring mechanically ventilated * subjects will have at least one additional stress ulcer risk factor exclusion criteria: * anticipated use of pre-pyloric enteral feeding after screening until the end of study * physician estimated survival of less then 96 hours * anticipation of major surgery within 96 hours of study enrollment

Keywords: stress ulcer critically ill gastric acid gastric aspirates esomeprazole
pc001- a study to evaluate the usability of pointcheck

Conditions: Neoplasms; Neutropenia

Summary: this a study about the usability of pointcheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia. the study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. a final sample size of 90 oncologic outpatients will be enrolled and studied with the technology. the main objective is to evaluate the usability of pointcheck. secondary outcomes include a preliminary assessment of pointcheck diagnostic accuracy and precision. for this, study subjects will be tested twice with pointcheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated


Eligibility criteria:
inclusion criteria: 1. able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. 2. male or female aged 18 years or above. 3. diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer. 4. scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia. 5. able (in the investigators opinion) and willing to comply with all study requirements exclusion criteria 1. participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator. 2. participants with a history of vasculitis, raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold. 3. participants with circulating tumour cells in previous or current lab determinations. 4. participants with leukemia. 5. participants with any condition producing significant tremor (e.g., essential tremor, parkinson´s disease, dystonic tremor). 6. inadequately medically controlled hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmhg). 7. participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device. 8. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. 9. other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.

Keywords: medical device technology non-invasive
4 week, safety and tolerability study in patients with mild to moderate alzheimer's disease

Conditions: Mild to Moderate Alzheimer's Disease

Summary: the primary purpose of the study is to determine the safety and tolerability of azd1446 vs placebo given as an add-on treatment to donepezil for 4 weeks in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * history of progressive worsening of memory and other cognitive functions for at least 12 months * treatment with stable dose of donepezil (10 mg) for at least 3 months * the patient should have an appropriate caregiver, who is required for all study visits exclusion criteria: * history of allergy/hypersensitivity reactions * significant neurological disease or dementia other than alzheimer's disease * myocardial infarction or acute coronary syndrome within the last year

Keywords: safety tolerability mild to moderate alzheimer's disease to determine the safety and tolerability of azd1446 vs placebo given as an add-on treatment to donepezil in patients with mild to moderate alzheimer's disease
pharmacokinetic study of porfiromycin in head and neck cancer and other cancer patients with solid tumors

Conditions: Head and Neck Neoplasms

Summary: study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin and major metabolites in head and neck cancer and other cancer patients with solid tumors who receive radiation therapy.


Eligibility criteria:
inclusion criteria: * patients with histologically proven advanced head and neck cancer or other solid tumors undergoing radiation therapy * patients with prior chemotherapy will be considered if chemotherapy occurred more than 30 days prior to this study * patients must be receiving concomitant radiotherapy (rt) * performance status of ≥ 70% on the karnofsky performance scale (kps) * must be ≥ 18 years of age * expected survival of at least three months * written informed consent exclusion criteria: * patients who meet any of the following clinical laboratory criteria: * granulocyte count of \< 2000/mm\*\*3 * platelets \< 75,000/mm\*\*3 * serum creatinine \> 1.5 times the upper limit of normal * bilirubin \> 1.5 times the upper limit of normal * prothrombin time and partial thromboplastin time \> 1.5 times the upper limit of normal * women who are pregnant * men and women of child-bearing potential who are unwilling to utilize a medically acceptable method of contraception * patients who have any known bleeding disorder at the discretion of the investigator * presence of any other life-threatening illness, such as unstable angina, severe oxygen dependent chronic obstructive pulmonary disease, or unstable liver or renal disease * treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor or interleukin-1l within 30 days prior to the start of rt * patients who have had prior exposure to mitomycin c or porfiromycin
luna interbody system for fusion trial

Conditions: Lower Back Pain; Degenerative Disc Disease (DDD)

Summary: the purpose of this trial is to evaluate the performance, safety and effectiveness of the luna system for the treatment of degenerative disc disease.


Eligibility criteria:
inclusion criteria: 1. age 18 - 65 at the time of consent 2. patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from l2-s1 requiring surgical intervention. 3. patient has had at least 6 months of non-operative care 4. patient is mentally capable and willing to sign a study-specific informed consent form 5. patient is willing and able to comply with all study requirements 6. patient has a score on the back pain visual analog scale (vas) of ≥ 40 mm 7. patient has an oswestry disability index (odi) score of ≥ 30% exclusion criteria: 1. ddd affecting \>2 levels 2. back pain due to causes other than ddd 3. spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure 4. \>grade 1 spondylolisthesis or retrolisthesis 5. infection at or close to target disc level 6. active systemic infection 7. patient has known osteoporosis 8. prior interbody fusion at the target level 9. prior failed interbody fusion at any level 10. known allergy to device materials 11. uncontrolled psychiatric illness or severe dementia 12. pregnant at time of enrollment or considering getting pregnant during study period 13. any metabolic or other bone disease that could significantly compromise pedicle screw and/or interbody device placement. 14. any severe illness that would prevent complete study participation 15. uncontrolled diabetes 16. current use of chronic steroids (more than equivalent of 10 mg prednisone daily) 17. contraindication to spinal surgery or general anesthesia 18. coagulopathy 19. body mass index \>35 20. current smoker 21. known illicit substance abuser 22. currently participating in another investigational study that could affect responses to the study device

Keywords: back pain spinal fusion degenerative disc disease (ddd) lower back pain fusion
clinical trial of approaches to prostate cancer surgery

Conditions: Prostate Cancer

Summary: this is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy. the investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.

traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (peyronie's disease), and inguinal hernia, are common. pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy. this study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.

Eligibility criteria:
inclusion criteria: * male sex * age ≥40 years or ≤80 years * scheduled for radical prostatectomy for clinically localized prostate cancer * able to read and speak english or spanish * willingness to sign informed consent and adhere to the study protocol exclusion criteria: * prior major pelvic surgery or radiotherapy * suspicion of n1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

Keywords: radical prostatectomy nerve sparing retzius sparing
cognitive behavioral intervention in diabetes self-management

Conditions: Type 2 Diabetes

Summary: the proposed study is a two arm randomized controlled trial with longitudinal follow-up that compares cognitive behavioral interventions (enhance) to a control group with attention. the experiment will consist of a repeated measure 2 x 3 design; condition (experiment vs. control) by time (pre, post, follow up).


Eligibility criteria:
inclusion criteria: * asian/pacific islander men and women with type 2 diabetes; asymptomatic for hyperglycemia * both men and women will be included in the study if they have a diagnosis of type 2 diabetes made by a physician and meet classification and diagnostic criteria established by the american diabetes association (american diabetes association, 1997) * between 18 and 76 years * participation in diabetes education program of university specialty clinics exclusion criteria: * crippling arthritis * joint replacements that limit movement * neuromuscular disease with paralysis * severe eye disease or visually impaired * chronic renal failure and/or end stage renal disease requiring hemodialysis or peritoneal dialysis * transplant recipient * foot amputation * congestive heart failure * new york heart class iii/iv * previous cerebral vascular accident (stroke) with residual paralysis * malignancy * chronic hepatitis c * hiv disease * individuals who contemplate changing residence within the period of study and becoming inaccessible to the study should be discouraged from the study

Keywords: type 2 diabetes asian pacific islanders cognitive behavioral intervention
covid-19 and cancer consortium registry

Conditions: COVID-19; Invasive Malignancy (Any Type)

Summary: in this study we will collect granular information on cancer patients infected with covid-19, as rapidly as possible. the mechanism for collection of this information is a de-identified centralized registry housed at vanderbilt university medical center, with data donations from internal and external health care professionals.

the covid-19 and cancer consortium (ccc19) registry prospectively collects anonymized data about patients diagnosed with covid-19 and cancer. the goal of the registry is to generate hypothesis-generating and hypothesis-supporting findings that are generalizable to the population at large. specifically: i. characterize patient factors, such as pre-existing comorbidities, baseline medication exposures, cancer type, status, and treatment, and demographic factors that are associated with short- and long-term outcomes of covid-19 (laboratory-confirmed or presumptive), including severity and fatality, in patients with cancer. ii. describe cancer treatment modifications made in response to covid-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. iii. evaluate the association of covid-19 with cancer outcomes.

Eligibility criteria:
inclusion criteria: • healthcare providers or their proxies who would like to report a patient with all of the following criteria: * suspected (presumptive positive based on clinical presentation) or lab-confirmed covid-19. * current or past medical history of invasive malignancy (any type) exclusion criteria: * participants at international sites not explicitly listed below * non-healthcare providers (or their proxies)
early induced hypernatremia for the prevention and management of brain edema

Conditions: Head Trauma

Summary: the purpose of this study is to estimate the effect of an early induced hypernatremia protocol (150-155 milliequivalent/l) versus normonatremia plus mannitol (135 - 145 milliequivalent/l) in terms of neurologic outcome in patients with severe traumatic brain injury managed at critical care unit.

severe traumatic brain injury is one of the main causes of death in young people. additionally, it is considered a public health problem because of the high prevalence of motor and cognitive dysfunction in those who survive. one of the cornerstones of management is the control of both intracranial pressure and brain edema. it is indicated to use osmotic active solutions to modulate the transit of fluids from the interstitial to the intracellular space. not only mannitol but also hypertonic saline acts at this point. currently there is no evidence in favor or against one of them. mannitol has been usually recommended for intracranial pressure control in patients with brain trauma. however, others recommend hypertonic saline to achieve a serum sodium level of 160 milliequivalent/l to modulate brain edema. it is not clear if these therapies have an impact on the neurologic prognosis and how frequently adverse effects occur.

Eligibility criteria:
inclusion criteria: 1. patient greater than 14 years old, who suffered severe non-penetrating brain trauma (glasgow coma scale (gcs) equal or less than 8) and a motor gcs equal or less than 5. 2. criteria time: admitted to the hospital in the first 24 hours of the brain trauma (bt) and admitted to icu in the first 48 hours of brain trauma. 3. tomographic evidence of brain edema (one of the following criteria: deviation from the midline, obliteration of perimesencephalic cistern or altered cortico-subcortical differentiation). exclusion criteria: 1. patient with gcs 3 and bilateral mydriatic pupils and unreactive to light, in the presence of hemodynamic stability (systolic blood pressure equal or greater than 90 mmhg). 2. patient with insipid diabetes at the icu admission. 3. patient with limitation of therapeutic effort. 4. non-neurological abbreviated injury score greater than 3. 5. patient past medical history of kidney failure, liver disease or heart failure. 6. serum sodium less than 135 or greater than 150 milliequivalent/l. 7. pregnancy. 8. terminal disease. 9. no authorization to be enrolled in the trial by the patient's caregiver

Keywords: cerebral edema hypernatremia extended glasgow outcome scale intracranial pressure mannitol hypertonic saline mortality
saphnelo systemic lupus erythematosus japan post-marketing surveillance (pms)

Conditions: Lupus Erythematosus, Systemic

Summary: to collect information on and evaluate the long-term safety and effectiveness of anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.

the objective of the specific use result study is to collect information on and evaluate the long-term safety and effectiveness of anifrolumab in patients with systemic lupus erythematosus insufficiently responding to currently available treatment in the real-world post-marketing setting. this investigation will be conducted to support the application for re-examination specified in article 14-4 of the pharmaceutical affairs law.

Eligibility criteria:
inclusion criteria: patients with systemic lupus erythematosus insufficiently responding to currently available treatment - exclusion criteria: none -
effect of lipid lowering agents on diabetic retinopathy and cardiovascular risk of diabetic patients

Conditions: Diabetic Retinopathy

Summary: the investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients

the investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ascvd risk score

Eligibility criteria:
inclusion criteria: * type 2diabetes * non proliferative diabetic retinopathy exclusion criteria: * uncontrolled glycemic level * proliferative diabetic retinopathy