Kornimate/medical-research-clean huggingface dataset:
home monitoring of diabetic macular edema

Conditions: Macular Edema Due to Diabetes Mellitus

Summary: diabetic macular edema (dme) is part of diabetic retinopathy (dr) and a leading cause of central visual loss in people with diabetes . most patients require pharmacological inhibition using anti-vascular endothelial growth factor (vegf) agents with multiple monitoring visits that include optical coherence tomography (oct), visual acuity test, and multiple injections.the substantial visit frequency puts pressure on ophthalmic clinics, and can impose a tremendous burden on both patients and their caregivers. therefore, self-service examination instruments that can be portable and fast-moving become the key for realizing tele-medicine. recently, the investigators have developed a portable, self-administrated home oct machine, which is designed for home-based oct scanning and monitoring for patients with retinal diseases including dme, age related macular degeneration (amd) and choroidal neovascularization (cnv) that require multiple anti-vegf injections. the investigators have confirmed its image quality and validated the retinal thickness measurements obtained from this device by comparing with hospital oct (staff-administrated and clinic-based).in this study, the investigators will conduct a randomized clinical trial (rct) to compare the efficacy and cost-effectiveness of a home oct monitoring model versus standard hospital care model for patients with diabetic macular edema who need anti-vegf injections.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. diagnosis of diabetic macular edema: * type 1 or type 2 diabetes mellitus; * center-involved macular edema; 3. willing to receive anti-vegf treatment; 4. media clarity, pupillary dilation, and individual cooperation sufficient for adequate oct examination; 5. able to operate self-administratedhome oct by themselves or with the help of family; 6. travel time from home to hospital: within 2 hours driving. 7. able and willing to provide informed consent. exclusion criteria: 1. history of systemic anti-vegf or pro-vegf treatment within 4 months prior to randomization. (these drugs should not be used during the study); 2. history of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months; 3. history of macular laser photocoagulation in the past 4 months; 4. macular edema due to reasons other than diabetes; 5. coexisting ocular diseases that might alter visual acuity during the course of the study, such as retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.); 6. hypertension (systolic blood pressure (bp) above 180 or diastolic bp above 110); 7. history of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization; 8. pregnant or lactating; 9. currently participating in other clinical trials;
clinical performance of the accelerate id/ast system for positive blood culture

Conditions: Bacteremia; Fungemia

Summary: the "evaluation of clinical performance of the accelerate id/ast system for positive blood culture identification \& antimicrobial susceptibility testing" is designed to validate the clinical performance of the accelerate id/ast system for positive blood culture identification and susceptibility testing in a clinical setting. the data from this study will be used to support the 510(k) submission for fda clearance and global registrations of the device intended for in vitro diagnostic use.

the clinical study entitled "evaluation of clinical performance of the accelerate id/ast system for positive blood culture identification \& antimicrobial susceptibility testing" is designed to demonstrate the clinical performance of the accelerate id/ast system for positive blood culture identification (id) and antimicrobial susceptibility testing (ast) in a clinical setting compared to reference results. approximately 3,000 positive blood culture samples (across all clinical sites) will be tested on the investigational device and reference methods. up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. quality control testing will be performed each day of testing. the study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. positive blood culture samples must be tested on the accelerate id/ast system within 8 hours of positivity by the blood culture monitoring system. testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.

Eligibility criteria:
inclusion criteria: * de-identified positive blood culture specimens (6 ml aliquot) * seeded blood culture specimens (stock) from archived bacterial and yeast isolates exclusion criteria: * sample volume available \< 6 ml * positive blood culture sample \> 8 hours post-positivity * sample from patient previously enrolled * sample from blood culture media that contain charcoal e.g., bactalert fa, fn bottles * samples from mycobacterial-type blood culture media e.g., bactec myco/f lytic, bact/alert mp bottle, versatrek myco

Keywords: positive blood culture
impact of microvascular inflammation on kidney allograft outcome

Conditions: Transplant;Failure,Kidney; Kidney Transplant Rejection

Summary: graft microvascular inflammation poses a significant challenge to successful kidney transplantation due to its heterogeneous clinical presentation. there is a critical need to unravel the clinical significance of newly defined allograft microvascular inflammation phenotypes in the banff 2022 classification and assess the implications of these new phenotypes on kidney transplant precision diagnostics and patient risk stratification.

antibody-mediated rejection is a major cause of graft failure in kidney transplant recipients, with allograft microvascular inflammation serving as the hallmark histological lesion of antibody-mediated graft injury. however, the frequent occurrence of graft microvascular inflammation in the absence of circulating anti-hla donor-specific antibodies highlights the incomplete understanding of the mechanisms underlying this inflammation. this heterogenous presentation poses a significant challenge in the clinical setting, as current treatment strategies often prove ineffective, hindering the improvement of allograft and patient care. the banff 2022 classification update has reappraised lesions of microvascular inflammation, identifying new diagnostic phenotypes of microvascular inflammation. however, the clinical significance of these phenotypes is yet to be determined. the aims of this study are: 1. to determine the impact of the revised banff 2022 classification on the diagnostic classification of phenotypes related to microvascular inflammation, compared to previous banff 2019 classification. 2. to assess the association of microvascular inflammation phenotypes with kidney allograft survival. 3. to assess the association of microvascular inflammation phenotypes with disease progression, defined by transplant glomerulopathy occurrence (cg and subsequent antibody-mediated rejection episodes.

Eligibility criteria:
inclusion criteria: * kidney transplant recipients, with at least one kidney transplant biopsy performed, assessed with the banff classification. exclusion criteria: * missing data for a rejection-related diagnosis according to the 2019 and 2022 banff classification.
efficacy of tdcs in the treatment of resistant auditory hallucinations in schizophrenia

Conditions: Schizophrenia; Hallucinations; Refractory Schizophrenia

Summary: the regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region. to assess the efficacy of tdcs on auditory hallucinations, the investigators performs an randomized double blind versus placebo trial. in each arms patients will receive two tdcs sessions a day during two weeks.

hearing hallucinations are one of the major symptoms of schizophrenia. in 30% of patients they are resistant to common psychotropic treatments. tdcs (transcranial direct current stimulation) is a technical of brain stimulation, non-invasive, painless that modulates brain activity by the transcranial administration of a low-intensity electric current, via two electrodes (an anode and a cathode). several scientifics studies have reported a beneficial effect of tdcs in the treatment of pain, depression and especially hearing hallucinations in schizophrenia. the main study purpose is to evaluate the effectiveness of tdcs on resistant auditory hallucinations in patients with schizophrenia. then, to evaluate the effectiveness of tdcs on global schizophrenic symptomatology and to assess the impact of tdcs on patients' quality of life. also the study, evaluate the impact of tdcs on cortical excitability. we measure the change in serum bdnf (brain derived neutrophic factor) before and after tdcs stimulation. indeed, to evaluate the impact of tdcs on neurocognitive functions. patients will receive either active tdcs or placebo tdcs randomly. all patients will have two tdcs/day sessions, one hour apart, for 2 working weeks. the stimulation parameters will be consistent with the literature data, namely: intensity = 2ma; duration of sessions = 20 minutes; total number of sessions = 20 (2 daily sessions for two working weeks).

Eligibility criteria:
inclusion criteria: * schizophrenia according to dsm-v. * refractory auditory hallucinations(despite two antipsychotics trials). * right-handed patients. * written informed consent. exclusion criteria: * presence of other psychiatric disorders than schizophrenia (except addiction to tobacco or caffeine ). * history of severe head trauma or coma. * history of epilepsy or neurological disorder or a general medical condition. * presence of intracranial metallic objects or pacemaker. * hospitalized patients without consent. * pregnant women .
a study of peginterferon alfa-2a in participants with chronic hepatitis b virus (hbv) in an expanded access program

Conditions: Hepatitis B, Chronic

Summary: this is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis b e antigen (hbeag) positive and hbeag negative chronic hbv infection. all participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.


Eligibility criteria:
inclusion criteria: * non-cirrhotic participants * hepatitis b surface antigen (hbsag) positive for at least 6 months * hepatitis b surface antibody (anti-hbs) negative * elevated serum alanine aminotransferase (alt) greater than (\>) upper limit of normal (uln) but less than or equal to (\</=) 10 times of uln * hbeag positive participants: hbv dna \> 500,000 copies/ml, hbeag negative participants: hbv dna \>100,000 copies/ml by polymerase chain reaction (pcr) * participants with chronic hepatitis b (chb) who are treatment-naive * no previous antiviral treatment with interferon (ifn: standard or pegylated) or with a nucleoside analogue * for women of childbearing potential: negative urine or serum pregnancy test documented within the 24-hour period prior to the first dose of test drug. willingness to use reliable contraception during the study and for 3 months after treatment completion exclusion criteria: * previous antiviral or ifn-based therapy for chb before enrolment * pregnant or breast feeding women participants * evidence of decompensated liver disease * co-infection with active hepatitis a, hepatitis c, hepatitis d and/or human immunodeficiency virus (hiv) * history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis * previous or current hepatocellular carcinoma * history of or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease * alpha-fetoprotein levels of \>100 nanograms (ng)/ml * severe psychiatric disease * history of a severe seizure disorder or current anticonvulsant use * history of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the participant, in the opinion of the investigator, unsuitable for the study * thyroid disease uncontrolled by prescribed medications * evidence of severe retinopathy * alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per day for women
long-term safety and tolerability study of brexpiprazole as adjunctive treatment in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to evaluate the long-term safety and tolerability of brexpiprazole as adjunctive treatment in patients with major depressive disorder (mdd)

this extension safety study was terminated early because one of the lead-in studies (14571a) in elderly was terminated and because the sponsor considered that sufficient long-term safety data has already been collected in the development programme in the population aged 18-65 yrs.

Eligibility criteria:
inclusion criteria: * the patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator. * the patient had mdd at entry in lead-in brexpiprazole studies, nct01838681 / 14570a or nct01837797 / 14571a, diagnosed according to dsm-iv-tr™. * the patient agrees to protocol-defined use of effective contraception. exclusion criteria: * the patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. * the patient has been diagnosed with a psychiatric disorder other than mdd during the lead-in studies nct01838681 / 14570a or nct01837797 / 14571a. * the patient, in the opinion of the investigator or according to c-ssrs, is at significant risk of suicide. * the patient has any relevant medical history or current presence of systemic disease. * the patient has, at the baseline visit an abnormal ecg that is, in the investigator's opinion, clinically significant. * the patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator. * the patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. other inclusion and exclusion criteria may apply.
cerebral oxygenation and autoregulation in preterm infants

Conditions: Intraventricular Hemorrhage of Prematurity; Complications of Prematurity

Summary: premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. the immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. the relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated. this study investigates the utility of near-infrared spectroscopy (nirs), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.


Eligibility criteria:
inclusion criteria: * inborn * birth weight \<= 1250 grams * indwelling arterial catheter in place * age \<24 hours old exclusion criteria: * lethal chromosomal abnormality * major congenital anomaly * skin integrity insufficient to allow placement of nirs sensors * decision to not provide full intensive care

Keywords: cerebral autoregulation preterm near-infrared spectroscopy
effectiveness of total hip arthroplasty for patients with osteoarthritis, a target trial emulation study

Conditions: Hip Osteoarthritis

Summary: the aim of this study is to assess the effect of total hip arthroplasty on hip disability and pain compared to non-surgery in patients with hip osteoarthritis, using target trial emulation to emulate a randomized controlled trial.

the ideal research design to investigate effectiveness of total hip arthroplasty (tha) would be to randomize patients between surgery and (delayed) non-surgery. such a randomized controlled trial (rct) is deemed unethical due to the effect size of tha shown in observational studies. in this study a target trial is specified (a randomized controlled trial between tha and non-tha) and the target trial is emulated using observational data of 2 dutch hospitals participating in the value based health care (vbhc) programme for hip osteoarthritis. the objective of this study is to compare the effect of tha surgery on hip disability and pain between patients that did or did not receive tha surgery during the covid-19 pandemic. it is hypothesized that tha is effective in restoring hip function and reduction of pain compared to the control group. the effect of tha has not been demonstrated by means of an rct before. this study can contribute to the available evidence by assessing causal effectiveness of tha by means of rct target trial emulation. as a secondary aim, the assumption of pseudo-random group allocation will be assessed. logistic regression analysis will be used to test whether group allocation is independent of patient characteristics (age, sex, hoos-ps baseline, nrs baseline, physical therapy before baseline and follow-up time.

Eligibility criteria:
inclusion criteria: * patients on the waiting list for primary tha between 1-4-2020 up until 31-3-2022 in olvg or martini hospital. * completed intake questionnaire (hoos-ps baseline) * indication osteoarthritis of the hip exclusion criteria: * patients that received tha on both sides within follow-up (1-4-2020 and 1-1-2022) will be excluded. * patients with other indications than osteoarthritis of the hip were excluded.
comparison of breathing exercise for hypertensive patients

Conditions: Hypertension

Summary: to determine the effectiveness of diaphragmatic breathing vs. slow breathing techniques on blood pressure and quality of life in adults with stage 1 hypertension. in accessible literature limited data was found on the comparison of different breathing techniques. the current study will compare the effect of slow vs. diaphragmatic breathing exercises and will demonstrate which one is more effective.

literature reports that inspiratory muscle training is more effective in reducing blood pressure and voluntary diaphragmatic breathing at 10 or 6 breaths per minute for 10 min twice a day for 4 weeks is effective in producing positive outcomes in hypertensive patients.

Eligibility criteria:
inclusion criteria: * patient having stage 1 hypertension, diagnosed after 1 week bp charting exclusion criteria: * patients taking antihypertensive medication patient having comorbidities smokers and women taking oral contraceptives

Keywords: stage 1 hypertension diaphragmatic breathing slow breathing quality of life
the use of nanoparticles to guide the surgical treatment of prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to see whether using the 64cu-nota-psma-peg-cy5.5-c' dot tracer is a safe way to identify tumor cells before and during surgery for prostate cancer. the researchers want to find out whether pet/mri scans done after the injection of this investigational tracer are more accurate than the usual imaging scans used to locate deposits of prostate tumor cells. the researchers will study how the tracer travels through your body and where it is distributed. this study is the first time that this tracer will be used in people who are undergoing surgery for prostate cancer.


Eligibility criteria:
inclusion criteria: primary rp + plnd * age ≥18 years * patients meeting one of the following criteria: * tumor clinical stage t3a or higher * gleason score 8-10, or * psa level \> 20 ng/ml * patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion * patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance) salvage plnd * age ≥18 years * patients with presence of suspicious lymph node on ct or mri (of a pelvic node =\> 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or psma-avid on psma pet imaging * patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion * patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance) exclusion criteria: * contraindications to standard-of-care mr imaging (e.g., metal implants, claustrophobia) * prior androgen-deprivation therapy for prostate cancer (n/a for salvage plnd) * prior pelvic radiotherapy (n/a for salvage plnd ) * medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer °this includes patients with uncontrolled infection, chronic renal insufficiency (egfr \< 60 ml/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or new york heart association classification iii or iv heart disease * weight greater than the 400-lb weight limit of the pet scanner * unmanageable claustrophobia * inability to lie in the scanner for 30 min

Keywords: molecular phenotyping ultrasmall silica nanoparticles pet/mri 64cu-nota-psma-peg-cy5.5-c' dot tracer 19-333
anti-mullerian hormone as predictor of ovarian responce to clomiphene citrate in pcos

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is found in 5% to 6% of women of reproductive age. it affects women's reproductive capability; thus patients have risks of infertility, miscarriage, and complicated pregnancy. a study revealed that the prevalence of oligoovulation or anovulation in patients with pcos ranged from 65% to 80%. anti-mullerian hormone (amh) is an important regulator in the ovary that play a rule during development and function. it is suspected to affect clomiphene citrate (cc) resistance. in this study the investigator will assess the accuracy of amh prediction of response to cc in women with pcos.


Eligibility criteria:
inclusion criteria: * women diagnosed with pcos * women 20-35 years old. * bmi ≤30 kg/m without previous ovulation induction. * partners with normal semen parameters parameter world health organization (who) 2010 volume1.5 ml concentration 15 million/ml progressive motility 32% normal forms 4% exclusion criteria: * women with evidence of hyper-or hypothyroidism, hyperprolactinemia, cushing's syndrome, congenital adrenal hyperplasia or androgen-secreting tumors. * women with factors of infertility other than pcos * women with incomplete data.

Keywords: anti-mullerian hormone