Kornimate/medical-research-clean huggingface dataset:
effect of intraocular lens (iol) centration and tilt on visual performance with clareon® vivity® iol implantation

Conditions: Cataract; Lenses, Intraocular

Summary: the goal of this observational study is to assess the effect of intraocular lens (iol) movement in patients who have undergone clareon® vivity® iol implantation. the main question it aims to answer is: does an association exist between iol movement and patient quality of vision? participants implanted with clareon® vivity® and vivity® toric iols will be asked to do the following: * consent to participate in the study * allow researchers to access their personal medical records * undergo a series of tests to assess the position of their iols and quality of vision researchers will assess participant examination results to determine whether an association exists between iol movement and patient quality of vision.

this is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (iol) centration and tilt on visual performance in patients who have undergone clareon® vivity® iol implantation. the study population will include individuals implanted with clareon® vivity® and vivity® toric iols. iol implantations reviewed will range from the earliest performed (may 2022) onward, until 100 implanted patients (200 eyes) are enrolled. potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * history of adult cataract and uneventful, refractive cataract surgery with clareon® vivity® or vivity® toric intraocular lens (iol) implantation with manifest refraction spherical equivalent (mrse) within ±1.00 d * willing to undergo an eye exam with pupil dilation exclusion criteria: * moderate to severe posterior capsule opacification (2+ or more) * yttrium aluminum garnet (yag) laser capsulotomy within 1 month prior to enrollment * laser-assisted in situ keratomileusis (lasik) or photorefractive keratectomy (prk) within the one year prior to iol implantation or any time after iol implantation * any previous ocular surgery (excluding yag, lasik, prk) * clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (amd), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma * any additional procedure(s) at the same time as the vivity implantation including but not limited to microinvasive glaucoma surgery (migs) * women who are pregnant at the time of screening (based on self-reported history) * medical or other problems which in the opinion of the investigator will render study participation unsafe

Keywords: extended depth of focus lens toric lens decentration tilt clareon vivity clareon vivity toric
pericardic adipose pedicle transposition over the myocardial infarct (adiflap trial)

Conditions: Myocardial Infarction

Summary: the purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle transposition (adiflap) for the improvement of cardiac function in patients with a chronic myocardial infarct. preclinical studies in the porcine model of myocardial infarction have shown that adiflap reduces infarct area.

this novel intervention consists of the pericardial isolation of adipose tissue maintaining its vascularization to create an adipose flap (adiflap) and its transposition fully covering infarcted myocardium.

Eligibility criteria:
inclusion criteria: * established transmural myocardial infarction non candidate to revascularization (\>3 months-old) * candidate to coronary by-pass for other territories different from the previous transmural infarct. * \> 18 years of age, male or female, capable of giving an informed consent. exclusion criteria: * severe co-morbidity associated with a reduction in life expectancy of less than 1 year. * severe valvular disease candidate for surgical restoration. * candidate to ventricular remodeling. * contraindication for nmr (creatinin clearance \<30 ml/min/1.73m2, metallic implants, claustrophobia). * severe renal or hepatic failure. * abnormal laboratory tests (no explanation at the time of inclusion). * previous cardiac intervention. * high surgical risk (euroscore 2). * pregnant or breast feeding women.

Keywords: regenerative medicine myocardial infarction
hematological parameters in axial spondyloarthritis

Conditions: Ankylosing Spondylitis

Summary: axial spondyloarthritis is an inflammatory disease characterized by the involvement of the sacroiliac joints and the spine. disease activity and structural changes are determined by using physical examination, imaging studies, laboratory parameters, and patient-reported indices. among laboratory studies, erythrocyte sedimentation rate (esr) and c-reactive protein (crp) are the most commonly utilized parameters. however, the level of esr and crp are inadequate in demonstrating disease activity and inflammation compared to other diseases. in this study, the investigators aimed to analyze and compare the systemic inflammatory index (sii), which is a hematologic parameter between subjects with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, and healthy controls. secondarily, the relationship between disease activity and enthesitis score and sii scores in patients with radiographic and non-radiographic axial spondyloarthritis will be investigated.

axial spondyloarthritis is an inflammatory disease characterized by the involvement of the sacroiliac joints and the spine. disease activity and structural changes are determined by using physical examination, imaging studies, laboratory parameters, and patient-reported indices. among laboratory studies, erythrocyte sedimentation rate (esr) and c-reactive protein (crp) are the most commonly utilized parameters. esr and crp are within the normal range in 40-50% of patients with spondyloarthritis and may remain within the normal range even during active disease. therefore, the use of biomarkers suitable for the pathophysiology of the disease have been recommended. however, these tests are difficult to access and there is no consensus on showing disease activity. systemic inflammatory index (sii) is a novel hematologic parameter and previous studies reported the relationship with disease activity in rheumatologic diseases, but the results are inconsistent. this study will compare the sii between subjects with radiographic and non-radiographic axial spondyloarthritis with healthy subjects. secondly, the study will investigate the relationship between sii, a new inflammation parameter, and disease activity in patients diagnosed with radiographic and non-radiographic axial spondyloarthritis.

Eligibility criteria:
inclusion criteria: * diagnosed with axial spondyloarthritis according to the asas classification criteria exclusion criteria: * acute/chronic infections * presence of other autoimmune diseases * diabetes mellitus * coronary arterial disease * hypertension * malignancy * hematological diseases * liver diseases * pregnancy/lactation * renal diseases

Keywords: ankylosing spondylitis disease activity inflammatory marker
transcranial direct current stimulation (tdcs)

Conditions: Brain Fog

Summary: cognitive impairment refers to when an individual struggles to learn, concentrate, remember, or make decisions. this can be due to underlying neurological diseases (i.e. alzheimer's disease, dementia, etc.), caused by viral illness (i.e. brain fog experienced by covid-19 survivors) or physical trauma (i.e. concussion). recent reports indicate that two out of three americans experience some amount of cognitive impairment in their lifetime. there are a number of therapies that have been used to help address this condition. one of these is transcranial direct current stimulation (tdcs), which delivers sustained direct current to to the head area via electrodes. a number of studies have indicated that this form of therapy is safe and efficacious at inducing neuroplasticity and exciting neuronal activity. these factors can help improve aspects of cognitive functioning such as working memory, learning, and task performance. the purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless, transcranial direct current stimulation for people with cognitive impairments.

sample size (n=10) is convenient and designed to explore acceptability and feasibility. participants who are enrolled will be provided a tdcs device to use for a period of four weeks. they will have two study visits, baseline (bl) and the 4th week visit (w4). during each visit participants will answer various questionnaires to assess patient-reported outcomes such as sleep quality, cognitive impairment, depression, anxiety, fatigue, and user acceptability. the entire cohort will receive a transcranial direct stimulation (tdcs) device which uses liftid neurostimulation technology (rpw technology, llc, new york, usa). participants will take the device home and daily, they will use the device for a maximum of 20 minutes to stimulate neuroplasticity. during the stimulation period they will be asked to perform a light activity such as reading, checking emails, etc. the participants will return to the mcnair campus for their final visit after 4 weeks.

Eligibility criteria:
inclusion criteria: * adults (aged 18+) suffering from poor working memory, brain fog, or cognitive impairments (such as dementia, alzheimer's, concussions, etc); ability to attend to the clinic for visits exclusion criteria: * severe cognitive decline that reduces their ability to interact with the tdcs device; major visual or hearing weakness reduces the ability to interact with tdcs device; major foot problems such as active lower extremity wounds, major foot deformity (e.g., charcot foot), previous major amputations, and claudication; demand-type cardiac pacemaker, implanted defibrillator, implanted metal plate in the brain or head, or other implanted electronic devices; epilepsy, seizures, brain lesions, or severe heart disease; sensitive skin or rash, broken skin, or open wounds; pregnancy; and any conditions that may interfere with outcomes or increase the risk of the use tdcs based on the judgement of clinicians

Keywords: cognitive impairment brain fog transcranial stimulation
levitra® 20mg special drug use investigation (long-term)

Conditions: Erectile Dysfunction

Summary: this investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ed) who cannot obtain sufficient efficacy by dose 10mg of levitra, and the target patients dose is increased to levitra 20mg. this investigation will be limited to the patients whose tolerability of levitra 10mg is judged to be no problem.


Eligibility criteria:
inclusion criteria: * this investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of levitra, and the target patients dose is increased to levitra 20mg. this investigation will be limited to the patients whose tolerability of levitra 10mg is judged to be no problem.

Keywords: erectile dysfunction, phosphodiesterase inhibitors
a trial of neurocognitive and supportive therapy interventions for individuals with parkinson's disease

Conditions: Parkinson's Disease; Mild Cognitive Impairment

Summary: this randomized, controlled trial (rct) evaluates the benefits of memory and problem solving training compared to supportive therapy in individuals with parkinson's disease with mild cognitive impairment (mci) and their support persons. participants will be randomly assigned to receive memory and problem solving training or supportive therapy for 2-months. a 6-month follow up evaluation will establish if benefits remain over time. impact of these therapies on thinking abilities, physical health, and patient and support person ratings of thinking skills, mood and quality of life will be evaluated. the memory and problem solving training is hypothesized to result in greater improvements and/or stability of function on neuropsychological tests of attention, working memory, learning, and memory skills compared to the supportive therapy condition. both conditions are hypothesized to result in improved mood and quality of life ratings. results from this study will determine whether memory and problem solving therapies and supportive therapy are easily used by and beneficial for individuals with parkinson's disease and mild cognitive impairment. if positive benefit is observed, information from this study will be used to further optimize these therapies for larger trials designed to evaluate the value of the therapies for individuals with parkinson's disease and their support persons.

the memory and problem solving training consists of a day calendar manual and note taking system and problem solving techniques. the supportive therapy offers patients and support persons the opportunity to discuss and reflect upon both parkinson's disease and non-parkinson's disease related problems.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease * clinical diagnosis of mild cognitive impairment exclusion criteria: * clinical diagnosis of dementia * clinical diagnosis of other parkinson's disease-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing

Keywords: parkinson disease mild cognitive impairment cognition executive function learning memory problem solving
effect of different plane blocks on quality of recovery and postoperative pain after laparoscopic hysterectomy

Conditions: Post Operative Pain

Summary: the goal of this clinical trial is to evaluate in effect of tap block and esp block on quality of recovery and postoperative pain after laparoscopic hysterectomy. the main question it aims to answer are: are these two plane blocks used superior to each other? participants; * will fill out the preoperative questionnaire * will fill out the postoperative questionnaire * will report their pain status according to the nrs score

standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (nsaids). generally, opiates and nsaids are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. the concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. it consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. erector spinae plane (esp) block is a recently described plane block designed to block the dorsal and ventral rami of the spinal nerves. and this block provides visceral and somatic pain block. transversus abdominis plane (tap) block involves the injection of la between the transversus abdominis (ta) and internal oblique (io) muscles.this interfascial plane contains the intercostal, subcostal, iliohypogastric, and ilioinguinal nerves. these nerves give sensation to the anterior and lateral abdominal wall as well as the parietal peritoneum, providing only somatic and not visceral analgesia.

Eligibility criteria:
inclusion criteria: * female patients who will undergo hysterectomy under elective conditions * 18- 65 years * asa i-ii patients exclusion criteria: * refusal during registration, request to be excluded from the study, failure to give informed consent * under 18 years old and upper 65 years old * asa iii-iv patients * chronic opioid use * presence of infection at the injection site * renal failure / liver failure * bupivacaine sensitivity * use of anticoagulants * bmi \ 35

Keywords: tap block esp block postoperative pain recovery
it to support integration of social determinant of health services to reduce avoidable emergency department visits

Conditions: Mental Health Issue; Substance Use Disorders

Summary: working through regional accountable care organizations (aco) the sponsor will establish a 2-year pilot project to demonstrate that early recognition and intervention in the various social determinant of health (sdoh) domains can reduce avoidable emergency department (ed) visits by high utilizers. the regional aco's will contract with medicaid managed care plans to assign traditional high ed utilizing members to the pilot project. members will be offered enhanced peer facilitated care management services connecting members with available sdoh community based services. members fitting our eligibility criteria will self-select by way of completing a pilot project consent form.

the project employs a two level intervention to include peer support specialist (pss) and community health advocate (cha). contact and engagement with participating members will be through both direct intervention in the emergency department by peer support specialist (the peer) as well as in the community for prevention visits and follow up by both the peer and community health advocate. these well-positioned peers and community health advocates will address behavioral and social determinants of health (sdoh) concerns through a highly coordinated intervention supported by a common it medicaid member tracking platform. this research project will determine the feasibility of deploying a single shared it platform that will include referral, appointment completion, and intervention outcome data. project staff will develop a trusting relationship with the members and will improve member access and engagement with community-based services. the project will also seek to determine the impact on total cost of care through redirecting study participants to community resources that are more appropriate, and less expensive than return visits to the emergency department.

Eligibility criteria:
inclusion criteria: * adults age 18 to 65 * new york state medicaid managed care members * have utilized emergency department services 6 or more times in a 12-month period * have been assigned to the pilot project by their medicaid managed care plan exclusion criteria: * individuals not assigned by a managed care organization meeting the above criteria
anti-inflammatory markers in endometrioma

Conditions: Endometrioma; Inflammation

Summary: investigators aimed to measure the serum levels of adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been demonstrated previously, in endometriosis patients and to find out any association of them with insulin resistance.

endometriosis is defined as the presence of endometrial gland and stroma outside the endometrial cavity affecting almost 10% of the women of reproductive age. although benign, it disrupts the quality of life of the inflicted patients through symptoms such as dysmenorrhae, dyspareunia, chronic pelvic pain, and infertility. the pathogenesis of endometriosis has not yet been clearly elucidated, however, recent papers implies an underpinning role of inflammation there is a limited number of studies about the levels of these parameters in endometriosis and to date, no report is available on the levels of adropin and netrin-1 in endometriosis. likewise, according to the investigator's literature search, no research explaining the association of endometriosis with insulin resistance has yet been published. in present study, in an attempt to describe inflammatory pathways playing a role in endometriosis pathogenesis, investigators aimed to measure the levels of serum adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been priorly demonstrated, and to find out any association of them with insulin resistance.

Eligibility criteria:
inclusion criteria: ·histopathologically confirmed diagnosis of endometrioma exclusion criteria: * any patients with dm, * chronic kidney disease (ckd), * cad, * heart failure (hf), * cerebrovascular accident (cva), * malignancy, * rheumatoid disorder, * liver disease, and * active infections were excluded from the study.

Keywords: endometrioma adropin salusin-α netrin-1 nesfatin-1 insulin resistance
dose escalation study with 99mtc - or 186 re-labelled humanised monoclonal antibody (hmab) biwa 4 in patients with head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: the general aim of the present study was to assess the safety and tolerability of intravenously administered technetium 99m (99mtc) and rhenium-186 radionuclide (186 re) -labelled hmab biwa 4, to confirm preferential accumulation in the tumour of 99mtc - labelled hmab biwa 4, to determine the maximum tolerated radiation dose of 186 re-labelled hmab biwa 4 and to propose a safety dose for phase ii development.


Eligibility criteria:
inclusion criteria: * patients with histological confirmation of squamous cell carcinoma in the head and neck * patients destined for surgery by means of neck dissection (part a) or : * patients with either local and/or regional recurrent disease for which curative treatment options were not available or distant metastases. the tumor deposits had to be measurable either clinically or by one or more radiological technique (s) (ct, mri, bone scintigraphy). because rit was expected to be more effective in smaller size tumor deposits, patients with lesions measuring \> 3 cm in greatest dimension were preferred (part b) * patients over 18 years of age * patients younger than 80 years of age * patients who had given 'written informed consent' * patients with a life expectancy of at least 3 months * patients with a good performance status: karnofsky \> 60 exclusion criteria: * life-threatening infection, allergic diathesis, organ failure (bilirubin \> 30µmol/l and/or creatinine \> 150 µmol/l) or evidence of a recent myocardial infarction on ecg or unstable angina pectoris * pre-menopausal women (last menstruation \<= 1 year prior to study start) * not surgically sterile (hysterectomy, tubal ligation) and * not practicing acceptable means of birth control, (nor not planned to be continued throughout the study). acceptable methods of birth control include oral, implantable or injectable contraceptives * women with a positive serum pregnancy test at baseline * chemotherapy or radiotherapy within 4 weeks before inclusion in the study * white blood cell count \< 3000/mm³, granulocyte count \< 1500/mm³ or platelet count \< 100000/mm³ * hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy