Kornimate/medical-research-clean huggingface dataset:
sami intervention study to evaluate smartwatch interventions in persons with mci and dementia

Conditions: Dementia; Mild Cognitive Impairment; Alzheimer Disease; Dementia With Lewy Bodies; Dementia, Vascular; Dementia, Mixed; Dementia Frontotemporal

Summary: assistive technologies (ats) can help people living with dementia (pwd) maintain their everyday activity. still, there is a gap between potential and supply. involving future users can close the gap. but the value of participation from pwd is unclear. the study examined smartwatch interactions from people with dementia or with mild cognitive impairment. participants received "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts on a customized smartwatch to perform everyday tasks. participants' reactions were observed via cameras. users' feedback was captured with questionnaires.

this was a mixed methods study involving different stakeholder groups in a stepwise approach towards the user-centered evaluation of a smartwatch-based application for pwd. a preparatory qualitative study focused on identifying needs and requirements for mobile assistive devices. an observatory field study revealed potential use cases for smartwatches for persons with dementia. the subsequent intervention study examined smartwatch interactions and gathered users' feedback concerning usability, design, usefulness and concerns. participants with mild cognitive impairment or dementia received either "regularly" (n=20) or "intensively" (n=20) intrusive audio-visual prompts to perform everyday tasks. all participants were prompted to complete two tasks, prompts were repeated up to three times if they failed to completely solve a task. prompts were triggered using a smartphone as remote control. patient reactions were observed via video cameras. each task was rated with 1 point for success, 0.5 for incomplete task fulfillment or 0 for failure. both tasks were summarized, resulting in success values from 0 to 2 points. abbreviations: pwd: people with dementia mci: mild cognitive impairment at: assistive technology

Eligibility criteria:
inclusion criteria: * diagnosis of mild cognitive impairment or dementia * mini mental status examination (mmse) ≥ 9 and ≤ 28 points exclusion criteria: * clinically relevant impairment of visual acuity and/or hearing * relevant speech/language impairment

Keywords: assistive technology user-centered design usability smartwatch dementia
influence of perioperative fluid therapy on hemoglobin and methemoglobin levels

Conditions: Perioperative/Postoperative Complications; Fluid Overload; Hemoglobin H

Summary: the objective of the study is to evaluate influence of perioperative fluid therapy on methemoglobin levels, and to changes in hemoglobin. further, changes in methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). patients undergoing major abdominal surgery will be included into the study.

increasing plasma volume by intravenous administration of crystalloid and/or colloid solutions may cause a relative reduction in hemoglobin (hb) concentration, a situation that is termed 'dilutional anemia'. such hemodilution may lead to an iatrogenic reduction in oxygen-carrying capacity and the development of organ dysfunction. paradoxically, large amounts of fluids that are administered with the aim of increasing oxygen delivery (do2), as is frequently done as part of perioperative goal-directed therapy; this may lead to an actual decrease in the do2 due to a decrease in hb concentration. another potential parameter that may reflect the development of dilutional anemia is methemoglobin (methb), a form of hb with reduced ability for oxygen binding. experimental studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide synthase (nos) and increase nos-derived nitric oxide (no) leading to local vasodilation and oxidization of hb to methb. methb may potentially serve as a biomarker of 'anemic stress' associated with reduced tissue perfusion during acute hemodilution.

Eligibility criteria:
inclusion criteria: * major abdominal surgery * informed consent exclusion criteria: * violation of study protocol

Keywords: fluid therapy perioperative hemodilution
determining change in cardiovascular and metabolic risks in patients with chronic phase chronic myeloid leukemia receiving bcr-abl tyrosine kinase inhibitor first-line therapy in the united states

Conditions: Chronic Phase Chronic Myeloid Leukemia

Summary: this non-interventional, prospective study will characterize the impact of three approved first and second generation bcr-abl1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase cml (cp-cml) patients who are tki naive and initiating first-line tkis in routine clinical practice in the us. all treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (soc)/routine office visits. additional research imaging will be performed and will be reviewed by core imaging laboratory. as the study is collecting data on management of cml, this study will not influence the prescribing or management practices at participating sites.

this non-interventional, prospective study will characterize the impact of three approved first and second generation bcr-abl1 tyrosine kinase inhibitors on cardiovascular and metabolic risk factors in chronic phase cml (cp-cml) patients who are tki naive and initiating first-line tkis in routine clinical practice in the us. all treatment decisions will be determined at the discretion of the treating physician(s) and data identifying the cardiovascular and metabolic risk factors will be collected. additional fasting blood samples (collected following 8 hours of fasting) will be collected during standard of care (soc)/routine office visits. additional research imaging will be performed and will be reviewed by core imaging laboratory. as the study is collecting data on management of cml, this study will not influence the prescribing or management practices at participating sites.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years at the time of ph+ cp-cml diagnosis 2. newly diagnosed chronic phase of ph+ cp-cml, confirmed with cytogenetic and/or molecular testing at baseline 3. treatment-naïve and initiating treatment with dasatinib, imatinib, nilotinib or bosutinib 4. willingness and ability to comply with routine office visits exclusion criteria: 1. any other prior or active non-cml active malignancy for which the patient is receiving treatment 2. participation in a therapeutic clinical trial for cml disease
glans size in hypospadias compared to normal

Conditions: Hypospadias; Surgery Non Hypospadias

Summary: the investigator will collect data on penile and glans size by age, weight and ethnicity in both patients undergoing routine urological surgery and hypospadias surgery.

after obtaining informed consent , the investigator will measure stretched penile length and glans size in 3 dimensions (length, width, height) in the office on patients with hypospadias, as well as at the time of operation, after the induction of anesthesia. patients undergoing hypospadias surgery will be considered study subjects. if the patient was given pre-operative testosterone as part of the current standard of care, this will be noted and the measurements taken at each pre-operative office visit will be recorded. the investigator will also record corrected age, weight in kilograms and ethnicity as identified by the family. control patients will be those male patients undergoing non-hypospadias urological surgery (hernia repair, orchiopexy, circumcision, re-circumcision) with a normal penis, the investigator will perform a single intra-operative measurement of the same glans and penile variables after induction of anesthesia and prior to the start of their genital surgery. again, age, weight and ethnicity will be recorded.

Eligibility criteria:
inclusion criteria: * patients undergoing surgery for hypospadias * patients undergoing any urologic surgery other than hypospadias exclusion criteria: * other penile abnormalities (hidden penis, penoscrotal wedding/transposition, chordee without hypospadias, penile torsion, etc.) * undergoing other penile procedures (penoplasty, chordee repair, penile detorsion, etc.)

Keywords: hypaspadias
investigation of related factors in patients with non-specific neck pain

Conditions: Neck Pain

Summary: it has been shown that there is a complex association between neck pain, temporomandibular joint dysfunctions, and migraines, and that these conditions can be influenced by factors such as depression, physical inactivity, and health-related quality of life. likewise, it is observed that all the factors within this complex structure can actually act as triggers, initiators, or intensifiers of each other. in recent years, with a more detailed examination of their physiological connections, a reciprocal triangular relationship has been demonstrated between temporomandibular joint (tmj) dysfunctions, headaches-especially migraines-and neck pain. a detailed correlation of risk factors affecting neck pain-primarily temporomandibular joint involvement and headaches-in patients with neck pain will help identify underlying secondary effects and facilitate the inclusion of patient-centered, specific exercises in rehabilitation programs for these patients. studies in the literature indicate that the relationship between neck pain, temporomandibular joint dysfunctions, and migraines has not been evaluated collectively, and the impact of factors such as depression, physical inactivity, and health-related quality of life on these conditions has not been thoroughly assessed. therefore, this study aims to comprehensively investigate the effects of temporomandibular joint dysfunctions, migraines, and other associated factors in individuals with non-specific neck pain.


Eligibility criteria:
inclusion criteria: * being between the ages of 18 and 70 * having non-specific neck pain * experiencing migraine-related headaches exclusion criteria: * having a diagnosis of cervical trauma, surgery, or disc herniation * having a diagnosis of abnormal range of motion in the tmj or cervical spine, scoliosis, or kyphosis * having neurological impairments * having systemic diseases * having dental or oral pathological lesions, oral infections, facial paralysis, or neuropathic facial pain

Keywords: non-specific neck pain temporamandibular joint dysfunction migraine health-related quality of life (hrqol) depression
comparison of vaginal and intramuscular progesterone in vitrified-warmed blastocyst transfer cycles

Conditions: Infertility

Summary: the aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their ivf treatment are not different with respect to the administration of progesterone (crinone® 8% vaginal gel versus intramuscular progesterone).

the hypothesis of this study is that the type of progesterone administered (intramuscular progesterone or crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and frozen before age 41 years. both intramuscular progesterone (25-100 mg compounded in oil) or vaginal progesterone (crinone® 8% vaginal progesterone gel) are widely used for luteal phase support in patients receiving vitrified-warmed embryos. crinone® 8% is fda approved for progesterone supplementation or replacement as part of an assisted reproductive technology (art) treatment for infertile women with progesterone deficiency (fda approval letter, 1997).

Eligibility criteria:
inclusion criteria: * signed informed consent * patient age at time of embryo freezing: 18 to 40.9 years * patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years) * blastocysts frozen by vitrification at brigham and women's hospital * standard eligibility criteria for blastocyst transfer at brigham and women's hospital exclusion criteria: * fresh or cleavage-stage embryo transfer planned * gestational carrier cycles * natural and modified natural cycles * embryos frozen more than once or derived from thawed oocytes * embryos frozen at centers other than brigham and women's hospital * embryos frozen using techniques other than vitrification (i.e. slow frozen) * patients with recurrent pregnancy loss, defined as failure of 3 or more clinical pregnancies * uterine factor infertility: asherman's, submucosal fibroids, polyp greater than 1 cm at time of embryo transfer, uninterrupted hydrosalpinx * patients with three prior failed embryo transfers (fresh or frozen) * bmi\ 40 kg/m2 at screening * currently breast feeding or pregnant * embryo biopsy performed * current smoking, alcohol or illicit drug use * allergy to study drugs * refusal or inability to adhere to study protocol * participation in other experimental drug trials concurrently within the past 60 days

Keywords: infertility in vitro fertilization embryo transfer blastocyst progesterone crinone
respiratory and cardiovascular effects in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to find out if subjects with chronic obstructive pulmonary disease have signs of accelerated ageing in their airways.

the age-related impairment of innate immunity and antioxidant defenses likely impacts on development and disease progression of chronic obstructive pulmonary disease, copd. it has been suggested that aging-related declines in function are accelerated in copd due to recurrent cycles of inflammation, tissue injury and repair, associated with long-term exposure to cigarette smoke or other airway irritants. here, the investigators aim to follow up on previous observations of impaired antioxidant responses in the lung of copd patients, to establish the extent to which this reflects an accelerated aging phenotype, to characterize the molecular mechanisms resulting in this functional deficiency. the proposed studies will employ well-characterized patients with copd of varying severity and smoking habits, as well as carefully age and smoking history-matched controls. accelerated aging within the copd lung will be assessed in endobronchial mucosal biopsies and airway macrophages by assessment of established senescence markers using immunohistochemical, biochemical and pcr-based methods. these markers of tissue age will then be related to the functional activation of transcription factors, known to be induced by oxidative stress and related to cytoprotection such as nrf2 and ap1. the investigators will also examine whether copd is associated with an enhanced secretion of inflammatory mediators from senescent cells, consistent with the accelerated aging paradigm and establish how this influences cell function. deficiencies in metal handling, antioxidant defenses and diminished airway innate immune defenses at the air-lung interface will be assessed. the aim is to identify biomarkers for the risk of rapid lung function deterioration in copd patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd, gold stage 2-3. * smoking history of at least 10 packyears. exclusion criteria: * severe ischemic heart disease. * other severe disease. * respiratory infection within four weeks.

Keywords: aging oxidative stress proteases bronchoscopy
deep lamellar endothelial keratoplasty: small incision technique

Conditions: Corneal Transplantation

Summary: the research objectives of this study are to determine if small incision deep lamellar endothelial keratoplasty (dlek) is able to further reduce the degree of corneal astigmatism and shorten the time course of corneal topography stabilization compared to standard full thickness corneal transplant (pkp) surgery.

split thickness lamellar corneal transplants have been performed for many years to replace the front part of the cornea and have been highly successful. what is different about this study is that the surgical procedure involves replacement of the back layers of the cornea rather than the front layers of the cornea. this replacement is done through a small pocket incision to avoid changes in the front surface of the cornea. by leaving the front surface in the cornea without sutures or incisions there is felt to be an advantage in healing and recovery time for the patient. in addition, this particular study will use a pocket incision that is even shorter and smaller in length than the one used in previous dlek surgeries to try to make healing time even faster and more predictable. this procedure has been successfully performed on patients in the netherlands for over five years. the procedure has also been successfully performed by doctors in the united states. subjects participating in this study will be among the first patients to undergo this procedure in the the university of texas southwestern medical center at dallas.

Eligibility criteria:
inclusion criteria: subjects enrolled in this study will have endothelial dysfunction to a level generally accepted as requiring standard pkp for treatment. subjects will be offered the alternative surgery of this protocol. all subjects will be between the ages of 21 and 95. males and females are eligible. - exclusion criteria: central corneal scars, presence of a filtering bleb and uncontrolled glaucoma. -

Keywords: deep lamellar endotheliam keratoplasty
the diagnostic performance of bmo-mrw and rnfl thickness and their combinational index using artificial neural network

Conditions: Glaucoma; Tomography, Optical Coherence

Summary: this study evaluates the relationship between bmo-mrw and rnfl thickness measured by oct. sd-oct exam will be performed to all patients in this study.

spectral domain optical coherence tomography, sd-oct, (heidelberg engineering, heidelberg, germany) is a widely used commercial device in ophthalmology field. for a long time, retinal nerve fiber layer (rnfl) thickness was measured with oct to detect and follow up glaucoma patients. bruch's membrane opening - minimum rim width (bmo-mrw) is relatively new parameter which measures the minimum distance between bruch's membrane opening to internal limiting membrane (ilm). bmo-mrw,a new parameter, is known to have better diagnostic performance than rnfl thickness and recently, many researches has been performed on this new parameter. sd-oct can measure rnfl thickness and bmo-mrw at the same time. the test procedure is not different from rnfl thickness measurement but only software implemented in oct device calculates bmo-mrw as well as rnfl thickness. the investigators are going to compare these two parameters and find out the relationship between two parameters.

Eligibility criteria:
inclusion criteria: * age \> 18 years with a clear cornea and clear ocular media * bcva ≥ 20/40 * refractive error within ± 6.0 diopters (d) of 0 and astigmatism ± 3.0 d of 0 exclusion criteria: * uveitis * secondary glaucoma * corneal abnormalities * non-glaucomatous optic neuropathies * previous trauma * ocular surgery or laser treatment * any other eye disease except glaucoma.

Keywords: oct rnfl bmo-mrw glaucoma
multidomain intervention for older adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder.

awareness of the necessity and importance of community-based multidomain psychosocial intervention for late-life depression has increased. however, few studies have attempted to integrate several therapeutic approaches in one intervention program. main objective of this study is to assess the effectiveness of a 12-week multidomain intervention with contingency management for reducing depressive symptoms in older adults with major depressive disorder. we plan to conduct a randomized controlled parallel-design study. we plan to allocate study participants to multidomain intervention or supportive therapy group, in a 1:1 ratio. block randomization using sas (plan procedure) and sample size estimation were performed. we estimated that, with at least 40 participants per group and an attrition rate of 10%, we could achieve a power of at least 0.80 (beta = 0.2, two-tailed alpha = 0.05). intervention was based on the financial and human resources of a community mental health service, and involved four home visits and 12 telephone calls over 12 weeks. four evidence-based therapeutic approaches (physical activity, healthy diet, social activity, and emotional regulation) were incorporated into the multidomain intervention program. to maintain participant motivation, we plan to apply contingency management based on operant conditioning theory. the primary outcome is the change in depressive symptoms, as measured by the montgomery-asberg depression rating scale (madrs). secondarily, we plan to investigate changes in resting-state functional connectivity in the default mode, salience, and central executive networks.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of non-psychotic, unipolar major depressive disorder, based on the mini-international neuropsychiatric interview 2. a montgomery-asberg depression rating scale (madrs) score of 17 or higher 3. the use of antidepressants at stable dosage for at least 6 weeks prior to study entry, without any recommendation for changes in medication for the 12 weeks of the intervention. pharmacotherapy was uncontrolled and was provided by physicians. exclusion criteria: 1. a history of psychiatric disorder (mental retardation, schizophrenia, bipolar disorder, and dementia) 2. a history of neurological disorder, such as brain tumor, intracranial hemorrhage, subarachnoid hemorrhage, epilepsy, hydrocephalus, encephalitis, metabolic encephalopathy, or other neurologic conditions that could interfere with the study 3. a history of significant hearing or visual impairment 4. a history of physical illnesses that could interfere with the study.

Keywords: community depressive symptoms mental health program older adults
comparison of discovisc and hydroxypropylmethylcellulose 2%

Conditions: Corneal Edema; Intraocular Pressure

Summary: this prospective study was performed to compare two ophthalmic viscosurgical devices, discovisc (hyaluronic acid 1.6% - chondroitin sulfate 4.0%) and hydroxypropylmethylcellulose 2% in terms of their overall clinical performance during phacoemulsification.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * grade 1-3 lens opacities classification system (locs iii) * pupil dilatation greater than 7.0 mm exclusion criteria: * black, brunescent, traumatic or subluxated cataract * corneal endothelial disease (endothelial cell count less than 2.000 cells/mm3) * glaucoma, uveitis * previous ocular surgery

Keywords: phacoemulsification corneal edema corneal endothelium viscoelastic substances