Kornimate/medical-research-clean huggingface dataset:
evaluation of quality of vision and visual outcomes with bilateral implantation of the clareon panoptix intraocular lens

Conditions: Cataract

Summary: to evaluate visual outcomes and quality of vision following bilateral implantation of the clareon panoptix intraocular lens (iol) targeted for emmetropia.

this study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity after successful bilateral cataract surgery. subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. clinical evaluations will include administration of a visual disturbance questionnaire (quvid), and a satisfaction questionnaire (iolsat), as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility criteria:
inclusion criteria: subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a trifocal iol * meet the requirements for on-label implantation of the trifocal iol * gender: males and females. * age: 40 or older. * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract). * expected visual potential of 20/25 snellen (0.10 logmar) or better in each eye. * all eyes will be in the range of availability for clareon panoptix iol and clareon panoptix toric iol. for cylinder below the toric iol indication (t3), an lri will be used during surgery. exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * patients with any corneal pathology (including corneal dystrophies, scaring, severe dry eye syndrome, irregular astigmatism, hoa) limiting or affecting visual potential. * patients with previous corneal refractive surgery. * patients with pre-existing ocular pathology, including maculopathy, armd, erm, prior rd, and glaucoma limiting or affecting visual potential. * subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. * participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating). the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
the effects of angiotensin ii receptor blockade on kidney function and scarring after liver transplant

Conditions: Liver Transplant Recipients

Summary: this research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

this study is a double-blinded, placebo controlled trial to help determine the pathogenesis of chronic renal dysfunction in patients undergoing liver transplantation. it will examine the renal function and renal morphology in patients on calcineurin inhibitors and the effects of cozaar (losartan) following liver transplantation. participants will have blood, urine and iothalamate clearance test, to look at kidney function prior to transplant. at the time of transplant, kidney biopsies will be performed in the operating room under anesthesia. participants will be in the study for one year. at three weeks following liver transplant, participants will be randomly assigned to receive either a placebo (inactive drug) or the study drug (losartan). the participant will need to continue to return to the clinic at the normal scheduled intervals. during these times blood and urine tests will be done. a kidney biopsy will be performed at the yearly exam and study pills will be stopped. the researchers will continue to follow participant's creatine measurements for the next 10 years.

Eligibility criteria:
participants who will be undergoing a liver transplant and are between the ages of 18 to 70 years of age.
the use of hospital and emergency department of refugee patients

Conditions: Refugees; Health Care; Outpatients; Emergency Departments

Summary: after middle eastern crisis, millions people were forced to migrate to european countries and especially neighboring countries. in turkey, cities which are closed to east of border, face to cope more refugees' health care than those of other cities. the incidence of admission of hospital outpatient clinics and emergency department by refugee patients is not known clearly in our city, nevsehir. in this study, we wanted to investigate use of health care among these patients in nevsehir in turkey.


Eligibility criteria:
inclusion criteria: all patients who visited an outpatient clinic and emergency department. exclusion criteria: patients who have missing records.
t regulatory cells in lupus nephritis

Conditions: Lupus Nephritis

Summary: * to study the role foxp3-positive t regulatory cells in the pathogenesis of lupus nephritis, and determine the factors associated with levels of t regs . * to compare the functional capacity of t regs in ln and in normal individuals.

lupus nephritis (ln) encompasses a group of glomerulonephrites, that occur in association with systemic lupus erythematosus (sle). the mainstream theory that it is an immune disease resulting from loss of immune tolerance against body cells. the regulatory t cells (t regs ) are a subpopulation of immune cells that maintain tolerance to self-antigens and suppress autoimmune diseases. the main marker of tregs is foxp3 (forkhead box protein 3) positivity. moreover, it has been suggested that functional capacity of tregs is also compromised in autoimmune diseases. studying the role of t regs in ln is a promising field that can help tailor current immune therapy and develop new treatment strategies.

Eligibility criteria:
inclusion criteria: adults both genders clinical diagnosis of lupus nephritis exclusion criteria: patients diagnosed with other renal pathologies, e.g. diabetic kidney disease
effects of light treatment during sleep on young men

Conditions: Depression

Summary: this study will determine if green light exposure during sleep is effective in reducing mild depression symptoms in young men.

the circadian rhythm is the human body's internal clock. it affects sleeping and wakefulness patterns. some scientists theorize that a disruption of circadian rhythms, or other circadian abnormalities, can cause a depressed state. light received through the eyes can alter the circadian rhythm, and sustained exposure to artificial bright light during the last half of usual sleep time can change the phase of the circadian rhythm. several studies have found that exposure to bright white light in the morning hours is an effective treatment for depression, especially during the first week of depression treatment. other studies have shown that green or blue light is preferable to yellow or red light in depression treatment. this study will expose young men to different types of light during the last part of their sleep cycle to determine whether the treatment is safe and tolerable and whether it reduces mood disturbance and depression. the study will also determine the light's effect on the production of luteinizing hormone (lh) and testosterone, hormones that may play a role in depression. participation in this study will last 15 days. at the beginning of the study, participants will be provided with study materials and instructed in their use. these materials will include a wrist actigraph, which is a sleep and wakefulness monitoring device similar to a wristwatch; a binder containing instructions, questionnaires, and forms; and a light mask. participants will be randomly assigned to receive a light mask with either intense green or dim red light. participants will wear the wrist actigraph throughout the study. for the first 3 days of the study, participants will sleep normally and fill out questionnaires and a sleep diary. the questionnaires will measure mood, sleepiness, sleep quality, treatment effects, and sleep time preference. the sleep diary will be a record of time spent sleeping, time it takes to fall asleep, number of times waking during the night, and similar measures. starting on the third night, participants will wear the light mask when sleeping. every day participants will fill out the questionnaires and sleep diary, and they will contact the study investigators to ensure compliance and to ask any questions. participants will also provide saliva and urine samples once at the beginning and once at the end of the study. these samples will be used to test for testosterone and lh, respectively.

Eligibility criteria:
exclusion criteria: * presence of clinical depression * presence of a sleep disorder

Keywords: delayed sleep phase syndrome sleep
improving dietary habit and weight loss in young adults with overweight and obesity: the healthy eating for young adults (heya) study

Conditions: Obesity

Summary: this study aims to examining the effectiveness of a psychoeducational program (healthy eating in young adults; heya) on improving the dietary habits and body composition (e.g. weight and percentage fat mass) in young adults in singapore.


Eligibility criteria:
inclusion criteria: 1. have a body mass index (bmi) ≥23kg/m2; and 2. are between the ages of 21 and 35 years old; and 3. can understand and read the english language; and 4. use a smartphone that can download apps; and 5. willing to travel to the national university singapore. exclusion criteria: 1. pregnant or lactating; and 2. participating in a structured weight loss program; and 3. planning or receiving pharmacotherapy or bariatric surgery within the next 6 months; and 4. has existing diagnosed mental disorder besides eating disorders.
soto: treatment sensitivity of organoids to predict treatment outcome

Conditions: Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer

Summary: in this study, we aim to assess whether patient derived organoids can be used to predict treatment sensitivity in hnscc patients.

this is a prospective observation study to generate patient-derived organoids from patients' samples to assess treatment response and to correlate with patients' treatment outcomes and to collect preliminary data on the ability of pdos to predict patients' treatment response and whether their radiosensitivity and chemosensitivity can be correlated with their survival outcome.

Eligibility criteria:
inclusion criteria: * patients with head and neck squamous cell carcinoma (including oral cavity, oropharynx, paranasal sinuses, hypopharynx or larynx) undergoing curative treatment (primary surgery or radiotherapy) or presenting with recurrent or metastatic cancers * age \> 18 years old exclusion criteria: * patients unable to give informed consent e.g. mental disability or vulnerable adults
long-term metazym treatment of patients with late infantile metachromatic leukodystrophy (mld)

Conditions: Late Infantile Metachromatic Leukodystrophy

Summary: this is a single center, open-label study of patients with late infantile mld. all patients were previous treated 26 weeks in the phase i trial (eudract number: 2006-005341-11, nct00418561). all patients will be offered continuing treatment in this study and will in this protocol receive 13 infusions, whereby the patients total have had 27 infusions of metazym. one infusion will be given every other week. after a total of 52 weeks of treatment the subjects will continue treatment in a compassionate use protocol. safety (ae/sae) will be monitored at every visit.


Eligibility criteria:
inclusion criteria: the patients from the phase i trial must meet the following criteria to be enrolled in the study. * subject's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject) * the subject and his/her guardian(s) must have the ability to comply with the clinical protocol exclusion criteria: * spasticity so severe to inhibit transportation * presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition that, in the opinion of the investigator, would preclude participation in the trial * any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial * use of any investigational product other than rhasa within 30 days prior to study enrolment or currently enrolled in another study which involves clinical investigations

Keywords: metazym late infantile metachromatic leukodystrophy long-term safety
life skills training workplace prevention program

Conditions: Job Satisfaction; Work Performance; Health Care Utilization; Depression Symptoms; Stress

Summary: a workplace health promotion intervention for youth age 16-24

a workplace health promotion intervention for youth age 16-24, adapted from the school-based life skills training program. the program teaches participants the skills necessary to be productive in work and personal settings while also promoting healthy behaviors and preventing or reducing health risk behaviors. program content focuses on goal-setting and problem-solving skills, stress and anger management skills, effective communication and conflict management skills, time and financial management, substance use risk reduction, and how to contribute to a healthy, safe, and drug-free workplace.

Eligibility criteria:
inclusion criteria: * employed at participating store exclusion criteria: -
motives for desiring children in different sexual-romantic orientations

Conditions: Family Characteristics; Sexual Orientation

Summary: the goal of this cross-sectional study is to compare the motives for the desire to have children in different sexual-romantic orientation. the main question\[s\] it aims to answer are: * do all orientations have the same motives for the desire to have children? * what are the preferred methods for having a child for the different orientations participants will answer an online questionaire . researchers will compare the different orientations to see if there are differences.


Eligibility criteria:
inclusion criteria: * all participants regardless of sex, gender or age exclusion criteria: * incomplete questionnaire * under 18 years * caring for a child in a social, economic or educational way (self-report)

Keywords: romantic orientation queer parenting
mk2461 in patients with advanced cancer (2461-001)(completed)

Conditions: Advanced Cancer

Summary: this is a first-in-human trial to establish the safety, tolerability, recommended phase ii dose (rp2d), pharmacodynamic, and clinical activity of mk2461.


Eligibility criteria:
inclusion criteria: * patients must be at least 18 years of age, with adequate organ function, and an ecog performance of \<2 * patients must be willing to undergo pre-study and post dose tumor biopsy and have tumor accessible to biopsy (waived during part a) exclusion criteria: * no chemotherapy, radiotherapy, or biological therapy with 4 weeks of study participation * patients must not have primary central nervous system tumor * patient has had prescription or non-prescription drugs or other products known to be metabolized by cyp3a4 that cannot be discontinued prior to day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study medication
docetaxel in non small cell lung cancer (nsclc)

Conditions: Lung Neoplasms

Summary: primary objective: * to classify the 2 study groups, according to the tumoral response. secondary objectives: * to evaluate the percentage of focused control per year. * to calculate the time until progression. * to evaluate the safety profile.


Eligibility criteria:
inclusion criteria: * non small cell lung cancer confirmed by histology or by cytology. * iiib stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation * general stage 0-1 at the ecog scale * loss of weight less than 5% in the 3 previous months from diagnose. * pulmonary function and gasometry results: fev1 \> 30% or 1 l, dlco (diffusing capacity of the lung for carbon monoxide) \> 30%, pco2 \ 60 mmhg. * normal medullar function (hemoglobin \> 11 g/dl, total wbc \> 1,5 x 10\^9/l, platelets \> 100 x 10\^9/l) * appropriate renal and hepatic functions * ctscan * anticonceptive method * available laboratory test (maximum 1 month before) exclusion criteria: * pleural discharge, upper cava vein syndrome or supraclavicular affectation. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of ly3372689 to assess the safety, tolerability, and efficacy in participants with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess the safety, tolerability and effect of study drug ly3372689 in participants with early symptomatic alzheimer's disease


Eligibility criteria:
inclusion criteria: * gradual and progressive change in memory function reported by participants or informants for ≥ 6 months * mmse score of 22 to 30 (inclusive) at baseline * cdr global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5. * meet 18f flortaucipir positron emission tomography (pet) scan (central analysis) criteria * have a study partner who will provide written informed consent to participate exclusion criteria: * contraindication to mri or pet scans * have known allergies to ly3372689, related compounds, or any components of the formulations

Keywords: dementia mild cognitive impairment prodromal alzheimer's disease tauopathy tau oga inhibitor
a phase 3 rollover study of lumacaftor in combination with ivacaftor in subjects 12 years and older with cystic fibrosis

Conditions: Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Summary: the purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with cystic fibrosis.

this is a phase 3, parallel group, multicenter, rollover study in participants with cf who are homozygous or heterozygous for the f508del cftr mutation and who previously participated in study 103 (study vx12-809-103, nct01807923), study 104 (study vx12-809-104, nct01807949), or cohort 4 of study 102 (study vx09-809-102, nct01225211).

Eligibility criteria:
inclusion criteria: * signed informed consent form (icf), and where appropriate, signed assent form. * participants entering the part a treatment cohort: completed 24 weeks of study drug treatment in study 103 or study 104 and elect to enroll in part a treatment cohort. * participants entering the part b treatment cohort: completed 56 days of study drug treatment in cohort 4 of study 102 and elect to enroll in part b treatment cohort. * participants entering the part a observational cohort: completed 24 weeks of study drug treatment in study 103 or study 104, but do not elect to enroll in the part a treatment cohort or do not qualify to enroll in part a treatment cohort. * willing to remain on a stable cf medication regimen through the end of study (part a and part b treatment cohorts only). exclusion criteria: * any comorbidity or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant (e.g., cirrhosis with portal hypertension). * pregnant and nursing females. females of childbearing potential must have a negative pregnancy test at the day 1 visit. * history of drug intolerance in the prior study that would pose an additional risk to the participant in the opinion of investigator or vertex. * history of poor compliance with study drug and/or procedures in the previous study as deemed by the investigator. * participation in an investigational drug trial (including studies investigating lumacaftor and/or ivacaftor, or studies requiring blood collections with or without administration of study drug)
increasing physical activity with a social robot-assisted exercise intervention in older adults with hearing loss: a feasibility and pilot randomized controlled trial

Conditions: Age-related Hearing Loss

Summary: objectives to assess the feasibility and acceptability of using a home-based, social robot-assisted intervention (srai) for older adults with hearing loss (hl), and to examine the preliminary effects of srai on improving physical activity, loneliness, communication, and health-related quality of life in this population. hypothesis to be tested srai is feasible for implementation at home and acceptable to participants. upon completing the 10-week intervention and the 1-month follow-up, the intervention group (ig) will report significantly greater improvements in measured outcomes. these findings will support subsequent investigations in a larger-scale randomized controlled trial (rct). design and subjects a two-arm, single-blinded, pilot rct with individual semi-structured interviews. chinese adults aged 65 years or older, with mild-to-moderate hl with a pure-tone average of 20-50 db across octave frequencies 0.5 to 4khz in both ears. study instruments this study will feature a 2 kg, 30 cm tall and 20 cm wide, cantonese-speaking humanoid social robot named kaka. interventions each ig participant will receive srai at home for 10 weeks. this will include auditory rehabilitation and 60 min/day, 3 days/week of varied multicomponent physical activity following the world health organization's evidence-based recommendations. the control group will engage in physical activity at the same intensity level and frequency as the ig without a robot. main outcome measures physical activity levels. data analysis descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used. expected results participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.


Eligibility criteria:
inclusion criteria: 1. ethnic chinese aged ≥65 years old living at home; 2. with mild to moderate hl with a pure-tone average of 20 to 50 db across octave frequencies 0.5 to 4khz in both ears; 3. no cognitive impairment \[score of ≦2 on the 5-item abbreviated memory inventory for the chinese (amic)\]; and 4. informed consent to participate in this study. loneliness is not a pre-requisite for taking part in the research. nevertheless, previous findings from a longitudinal cohort study indicate that approximately 46.6% of older adults with hearing loss reported feeling lonely. exclusion criteria: 1. those with a diagnosis of a major neurocognitive disorder; 2. a history of symptomatic stroke or other disease of the central nervous system; 3. a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with using a robot or using hearing aids and hearing assistive technologies; 4. have limited access to electricity at home.

Keywords: age-related hearing loss physical activity health-related quality of life