Kornimate/medical-research-clean huggingface dataset:
clinical investigation of a new version of maia microperimeter on healthy subjects and patients with retinal pathology

Conditions: Healthy Eyes; Retinal Diseases

Summary: the purpose of this pre-market, monocentric cross-sectional study is to evaluate the clinical usefulness of a new version of the maia device (maia) through an agreement with the established version of the maia microperimeter (maia 2013 edition). moreover, the study aims to evaluate maia test-retest repeatability in comparison with maia 2013 edition and to evaluate maia safety and adverse events. these purposes will be achieved by collecting data of healthy subjects and patients with retinal pathology. all participants will undergo repeated microperimetric examinations with both devices during one single visit.


Eligibility criteria:
healthy subjects inclusion criteria: * age: 18-90 years old; * bcva ≥ 0.8 decimal; * equivalent spherical refraction between -12d and +6d; astigmatism within 2d; * iop ≤ 21 mmhg; * clinically normal appearance of the optic nerve head (examined with spectralis oct); * clinically normal appearance of the macula (examined with spectralis oct); * no ocular pathologies, trauma, surgeries; * absence of pathologies that can affect visual field; * no use of drugs inferfering with the correct execution of perimetry; exclusion criteria: * glaucoma or glaucoma suspect diagnosis; * iop ≥ 22 mmhg; * presence or history of disc hemorrhage; * presence of amblyopia; * nystagmus or poor fixation; * previous laser or any ocular surgery, including uncomplicated cataract surgery performed within 6 months before enrollment; * any active infection of anterior or posterior segments; * subjects with significant ocular media opacities; * evidence of diabetic retinopathy, diabetic macular edema, or other retinal disease; * use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss; * unable to tolerate ophthalmic imaging; * claustrophobia; * inability to provide informed consent. patients with retinal pathology inclusion criteria: * age: 18-90 years old; * bcva ≥ 0.1 decimal; * equivalent spherical refraction between -12d and +6d; astigmatism within 2d; * diagnosis of any type of retinal disease by investigator based on fundoscopy and spectralis oct for which microperimetry is indicated; exclusion criteria: * any ocular surgery, with the exception of uncomplicated cataract surgery performed at least 6 months before enrollment; * subjects unable to tolerate ophthalmic imaging; * nystagmus; * subjects with significant ocular media opacities; * use of any drug that can interfere with the correct execution of microperimetry or that would produce visual field loss; * claustrophobia; * inability to provide informed consent; * vulnerable subjects according to the investigator's judgement.
an observational study to assess liver fibrosis stages in patients with chronic hepatitis c infection

Conditions: Hepatitis C, Chronic

Summary: this multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis c. data will be collected for 96 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic hepatitis c infection (mono-infection or co-infection with human immunodeficiency virus \[hiv\]) * detectable level of hepatitis c rna * initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines * last liver biopsy performed no later than 3 months prior to enrolment to study exclusion criteria: * co-infection with hepatitis b virus * previous treatment with pegylated interferon and ribavirin * participation in another clinical study in the last 12 months prior to study start
incidence of hoarseness after general spine surgery: prospective observational study

Conditions: Hoarseness

Summary: early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. therefore, appropriate research on the incidence of hoarseness after surgery is necessary. in this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the voice handicap index (vhi)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.

the primary outcome of this study is the incidence of hoarseness on the day of surgery. the secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness. investigator conducted a comparative analysis of risk factor for hoarseness in patients with different vhi-10 scores on the day of surgery and 30 days after surgery.

Eligibility criteria:
inclusion criteria: * age range is 20 to 80 years old * degenerative spine conditions * visit at seoul national university hospital only * patients who voluntarily consent to participate in the study exclusion criteria: * history of surgery around the airway or mediastinum * patients with vocal cord-related disorders * patients with fractures, bleeding, or other trauma * patients with neuromuscular diseases, parkinson's disease, or psychiatric disorders * patients who cannot be extubated or who are transferred to the icu after surgery * pregnant women * patients who do not wish to participate in the study

Keywords: hoarseness spine surgery
subcutaneous adaption and cosmetic outcome following caesarean delivery

Conditions: Caesarean Delivery

Summary: this is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after caesarean delivery.


Eligibility criteria:
inclusion criteria: * women undergoing cesarean section for any indication * literate in german language exclusion criteria: * history of keloids * previous transversal suprapubic scars * known patient hypersensitivity to any of the suture materials used in the protocol * a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)

Keywords: wound closure cosmetic outcome
duration of clopidogrel therapy after drug-eluting stent (des-late)

Conditions: Coronary Artery Disease

Summary: this is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.

this is subsequent clinical trial of previously published pooled analysis of the real-late and the zest-late trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.

Eligibility criteria:
inclusion criteria: * 1. patients had undergone des implantation at least 12 months before enrollment, had not had a mace (death, mi, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment. * 2. time for index pci to randomization: 12-18 months exclusion criteria: * contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding) * concomitant vascular disease requiring long-term use of clopidogrel * other established indications for clopidogrel therapy (e.g., a recent acs). * noncardiac coexisting conditions with a life expectancy \< 1 year.

Keywords: coronary disease stents antiplatelet drugs drug-eluting stents
mass balance study of [14c]lc350189 in healthy volunteers

Conditions: Gout; Hyperuricemia

Summary: this is a phase 1, open-label, single-dose, mass balance study designed to evaluate the absorption, metabolism, and excretion of \[14c\] radiolabeled lc350189 after oral administration.


Eligibility criteria:
inclusion criteria: * the subject is male 18 to 55 years of age, inclusive. * the subject has a body mass index 18 to 32 kg/m2, inclusive, at screening. * the subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram results, and physical examination findings at screening. * the subject is able to provide written informed consent. exclusion criteria: * the subject has a medical history of any issues affecting absorption or metabolism, as judged by the investigator. * the subject has a medical history of any problems affecting venous access or bowel/bladder function. * the subject has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening. * the subject has used any prescription or over the counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days before the first dose of study drug. * the subject has consumed grapefruit or grapefruit juice, seville orange or seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or during the study. * the subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug. * the subject is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or during the study. * the subject has donated blood or blood products \>450 ml within 30 days before the first dose of study drug. * the subject has a history of relevant drug and/or food allergies (ie, allergy to study drug or excipients, or any significant food allergy that could preclude a standard diet in the clinical unit).
long-term follow up after sg vs rygb vs oagb

Conditions: Weight Loss

Summary: a prospective randomized clinical study of all morbidly obese patients undergoing sg, rygb and oagb, as primary bariatric procedures, was performed. patients were randomly assigned into 3 groups: those patients undergoing sg, those ones undergoing rygb and those ones undergoing oagb. bmi, excess bmi loss (ebmil) and remission of type 2 diabetes (t2dm), hypertension (ht) and dyslipidemia (dl) were assessed.

a prospective randomized clinical study of all morbidly obese patients undergoing sg, rygb and oagb, as primary bariatric procedures, was performed. patients were randomly assigned into 3 groups: those patients undergoing sleeve gastrectomy, those ones undergoing roux-en-y gastric bypass and those ones undergoing one-anastomosis gastric bypass. body mass index (bmi), excess bmi loss (ebmil) and remission of type 2 diabetes (t2dm), hypertension (ht) and dyslipidemia (dl) were assessed.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>40 kg/m2 * bmi \> 35 kg/m2 with the presence of comorbidities associated to obesity * age older than 18 years * patients willing to participate in the study and giving their written consent exclusion criteria: * patients undergoing other bariatric techniques than sg, rygb and oagb * patients undergoing any other surgical procedure added to the bariatric surgery * patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study * inability to understand the nature and purpose of the study and / or to accept written participation in the study * impossibility to comply with pre-established clinical follow-up.
samtasu post-marketing general drug use-results survey in patients with volume overload in heart failure.

Conditions: Heart Failure

Summary: to confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * patients with a known hypersensitivity to tolvaptan sodium phosphate or tolvaptan
a study of encorafenib plus cetuximab taken together with pembrolizumab compared to pembrolizumab alone in people with previously untreated metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired dna mismatch repair (mmr) * has a certain type of abnormal gene called "braf" and; * has not received prior treatment. all participants in this study will receive pembrolizumab at the study clinic as an intravenous (iv) infusion (given directly into a vein) at the study clinic. in addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by iv infusion at the study clinic. the study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility criteria:
inclusion criteria: * locally confirmed microsatellite instability-high/ deficient mismatch repair (msi-h/dmmr) stage iv colorectal carcinoma * locally confirmed braf v600e mutation in tumor tissue or blood * eastern cooperative oncology group (ecog) performance status of 0 or 1 * have not received prior systemic regimens for metastatic disease. * measurable disease per recist 1.1 * adequate organ function exclusion criteria: * colorectal adenocarcinoma that is ras mutant or for which ras mutation status is unknown * known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease * immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years * presence of acute or chronic pancreatitis * clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior) * received a live or live-attenuated vaccine within 30 days of planned start of study medication * previous treatment with any selective braf inhibitor (eg, encorafenib, dabrafenib, vemurafenib, xl281/bms-908662) or any epidermal growth factor receptor (egfr) inhibitor (eg, cetuximab, panitumumab). * previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death \[pd-1\], anti-pd-l1 or anti-pd-l2 agent); or with an agent directed to another stimulatory or co-inhibitory t-cell receptor (eg, ctla-4, ox 40, cd137).

Keywords: keynote-d31 braf v600e mutation positive colon cancer rectal cancer metastatic colon cancer colon cancer braf rectal cancer braf msi-h colorectal cancer msi-h colon cancer
oncology episode payment model in hawaii

Conditions: Breast Cancer; Colon Cancer; Lung Cancer

Summary: the hmsa cancer episode payment model (cem) is a payment model designed to test the effects of better care coordination on health outcomes and costs of care for hawaii medical services association (hmsa) members with cancer who receive chemotherapy.

the cem is designed to improve community health, to improve care coordination, quality, and appropriateness of care, to improve patient experience, and to implement a value-based incentive structure that appropriately rewards oncologists for cost-savings and sustained of improved quality of care.

Eligibility criteria:
inclusion criteria: * any oncologist who practices with hawaii oncology and is a participating provider. exclusion criteria: * any provider who does not practice with hawaii oncology.
electronic post-treatment surveillance program for prostate cancer survivors (ehealth)

Conditions: Prostate Cancer

Summary: the purpose of this single institution pilot study is to determine the feasibility of implementing an ehealth prostate cancer surveillance program through the evisit electronic medical record patient portal. the investigators will assess patient compliance and satisfaction with evisit follow up care in lieu of in person clinic visits.

telehealth offers the opportunity to transform cancer surveillance into a patient-centered effort with shared leadership between patient and oncologist. peer-to-peer electronic communications can improve the collaboration between oncologist and primary care provider (pcp) as patients transition back to primary care as their primary health provider. the investigators propose to test a patient-centered ehealth surveillance program utilizing novel asynchronous telehealth tools to provide patient-reported outcome symptom monitoring using the electronic medical record's patient portal (evisit).

Eligibility criteria:
inclusion criteria: * ≥ 18 years old with histologically confirmed prostate cancer * completed curative intent treatment to the prostate +/- pelvis * deemed to be "without evidence of active disease" by treating provider with at least 1 follow up visit 3 or more months after treatment completion * mychart account or willingness to open account * access to the internet exclusion criteria: * documented extrapelvic metastases * psa meeting definition of recurrence (\>0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) and rising with doubling time less than 1 year
educational intervention targeting statin therapy and compliance in diabetic patients

Conditions: Type II Diabetes

Summary: the objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. this intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.


Eligibility criteria:
inclusion criteria: * 18 years old or more * type 2 diabetes * following treatment with statins * hospitalization in the diabetes day hospitals of the saint philibert or saint vincent hospitals (lille, france). * ability to answer the girerd test in both interviews (in the individual interview and by phone) * patient informed to participate in the study * signed patient's consent. exclusion criteria: * patients under guardianship

Keywords: diabetes compliance statin education
effect on orencia (abatacept) on the apoptosis of t cells, b cells and apc cells in rheumatoid arthritis

Conditions: Apoptotic DNA Damage; Rheumatoid Arthritis; T-cell Lymphocytosis

Summary: this proposal will test the hypothesis that orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (ra) patients.

orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis (ra) patient's cells. to date, no studies have been performed to evaluate the effect of orencia on apoptosis in ra patients. primary: to determine the effect of abatacept in the apoptosis of t cells, b cells and antigen presenting cells (apc) in ra patients at baseline, 3 months and 6 months. secondary: to evaluate the association between the changes in apoptosis to changes in disease activity measures (das28/esr) over 6 months of treatment with subcutaneous injection of abatacept.

Eligibility criteria:
inclusion criteria: 1. over age 18 2. meeting acr criteria 1987 for ra diagnosis 3. naïve to treatment with abatacept 4. must be able to understand information in the informed consent exclusion criteria: 1. pregnancy or breast feeding 2. previous exposure to abatacept. 3. history of a concomitant autoimmune disease (eg. sle, psa etc.) 4. patients with history of cancer

Keywords: apoptosos rheumatoid arthritis t cells, b cells das28 clinical disease activity index cdai
changes in retinal nerve fiber layer thickness detected by oct in diabetic retinopathy after panretinal photocoagulation

Conditions: Retinal Disease

Summary: panretinal photocoagulation reduces the risk of visual loss by 50% in patients with diabetic retinopathy. it is recognized that laser expansion into the retina may be associated with photoreceptor loss, retinal pigment epithelial hypertrophy and visual field loss. panretinal photocoagulation can cause alteration in retinal vascular permeability therefore, retinal thickness may be increased including retinal nerve fiber layer. on the contrary, it can damage retinal cells including ganglion cells, which may decrease the retinal nerve fiber layer thickness in the latter follow up period. peripapillary retinal nerve fiber layer can be measured by optical coherence tomography which is a non-invasive technique for obtaining high resolution cross sectional images of a tissue.

pre laser assessment: * assessment of medical and family history * refraction and best corrected visual acuity * anterior segment examination using binocular slit lamp bi-microscopy. * posterior segment examination. * oct scan of peripapillary area post laser assessment ( at 1,3 and 6 months): * refraction and best corrected visual acuity. * anterior segment examination using binocular slit lamp bi-microscopy. * posterior segment examination. * oct scan of peripapillary area.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of proliferative diabetic retinopathy. * treated by panretinal photocoagulation. * age between 40-70 years old. exclusion criteria: * patients with densely opaque media (as dense cataract or vitreous hemorrhage). * glaucomatous patients. * any other associated retinopathy.
cognitive training and practice effects in mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the current study will test the effectiveness of a computerized cognitive training program on auditory memory and attention in patients with mild cognitive impairment. practice effects will also be examined as a moderator of treatment response.

the current study will test the effectiveness of a computerized cognitive (thinking) training program on improving thinking and memory in patients with mild cognitive impairment. the investigators will also examine how short term changes in thinking abilities (i.e., practice effects) can be related to improvement in thinking abilities after the cognitive training program.

Eligibility criteria:
inclusion criteria: * mild cognitive impairment, amnestic subtype * 65 years of age or older * availability of a knowledgeable informant * access to internet 3 hours per week * adequate vision, hearing, and motor responding to participate in training exclusion criteria: * history of major stroke, head injury with loss of consciousness of \>30 minutes, or other neurological disorder or systemic illness that are thought to be affecting cognition (e.g., seizure disorder, demyelinating disorder, etc.) * current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder) * history of substance abuse * current use of antipsychotics or anticonvulsant medications * currently residing in a nursing home or other skilled nursing facility