Kornimate/medical-research-clean huggingface dataset:
development of core outcomes for age-related macular degeneration (amd) interventions- caregivers' perspective

Conditions: Age Related Macular Degeneration

Summary: this study will explore experience of amd caregivers in order to develop a core outcome set (cos) for age related macular degeneration (amd) randomised controlled trials (rcts) trying to capture what research outcomes are important from their perspective. people 18 years of age and older who have been amd caregivers for at least 6 months may be eligible for this study. the aim is to conduct three focus groups lasting approximately one hour. the plan is to enrol 18-24 participants (6-8 participants per each of 3 focus groups).two researchers will be involved in conducting the focus groups. a moderator will ensure fluid discussion, while the second investigator will be taking notes and audio-recording the discussion.

randomised controlled trials (rcts) are widely employed interventional studies in medicine, yet many times their outcomes are presented inconsistently. the comet initiative (core outcome measures for effectiveness trials) suggests that a solution for that issue would be preparation of a core outcome set (cos)a minimal group of outcome measures relevant to different group of stakeholders (e.g. clinicians, patients, carers) that would be implemented in each rct in a particular area. the overall aim is to prepare a cos for age related-macular degeneration (amd) rcts. as first step to develop a cos for amd, the investigators conducted a systematic review that confirmed variability in amd trials' outcome selection. the current step encompasses involvement of different stakeholders' groups in focus groups: patients and caregivers (current project) such as family members and friends helping amd patients with their everyday living. knowledge of caregivers' perspective on living with, treatment and outcomes for amd is a key consideration when building up a cos, because they may not only evaluate existing outcomes, but also their experience may be translate into new outcomes. in the current focus group study, caregivers will be invited for a one hour discussion. the investigators plan to arrange three focus groups with approximately 8 participants each. two researchers will be present to help facilitate discussion. participants will be asked about their experience related to their help brought to amd patients, observations of living with and treatment of amd as well as about amd study outcomes and their importance.

Eligibility criteria:
inclusion criteria: * english speaking participants * amd patients' caregivers defined as people actively taking part in providing support for amd patients * being a caregiver for at least 6 months * having daily contact with amd patients (not necessarily living with patients) exclusion criteria: * non-english speaking participants * being a caregiver for less than 6 months * not having daily contact with amd patients
to demonstrate the relative bioequivalency of comparing single 100 mg doses of cord's 50 mg desipramine hcl tablets to merrell dow's 50 mg norpramin tablets

Conditions: Depression

Summary: to demonstrate the relative bioequivalency of comparing single 100 mg doses of cord's 50 mg desipramine hcl tablets to merrell dow's 50 mg norpramin tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antidepressant
effect of delta sodium on the postoperative outcomes in liver transplant recipients

Conditions: Liver Transplant; Complications; Perioperative/Postoperative Complications; Electrolyte Disturbance

Summary: we analyzed the association of delta sodium levels with their effect on post liver transplant outcomes in consecutive patients undergoing liver transplantation. records were analyzed for electrolytes and outcome measures, and data was analyzed.

preoperative hyponatremia was identified in patients. the mean change in sodium in hyponatremic patients was compared with inpatients with normal sodium levels. the impact of the delta sodium levels with short-term outcomes, such as duration of intubation, intensive care unit length of stay were analyzed with univariate and multivariate logistic regression analyses.

Eligibility criteria:
inclusion criteria: * all liver transplant recipients between jan 2011 to jan 2017 * records available exclusion criteria: * acute fulminant liver failure * all patients less than 18 years * re operated cases * pregnant patients

Keywords: liver transplantation perioperative sodium sodium
a self-management program for adults with both schizophrenia and a co-occurring medical condition

Conditions: Schizophrenia

Summary: this study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.

schizophrenia is a life-long brain disorder affecting approximately 1 percent of americans each year. schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. people with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. this can make holding a job or even caring for oneself very difficult. the purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition. participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. in addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. homework will be assigned weekly for participants to review skills learned in each session. after each session, participants will complete a survey to evaluate the session's effectiveness. at the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. the results of this study will be used to evaluate and improve the self-management program for future use.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for schizophrenia or schizoaffective disorder * current documented chart diagnosis of at least one chronic medical condition * received clinic services for a minimum of 3 months prior to study entry * english-speaking * willing to use an effective form of birth control throughout the study if sexually active exclusion criteria: * history of a serious neurological disorder or head trauma with loss of consciousness * diagnosed with mental retardation or dementia * diagnosed with end stage organ disease * currently receiving chemotherapy and/or radiation treatment for cancer * received psychiatric hospitalization less than 3 months prior to study entry date * blind and/or deaf * pregnant * infected with hiv with a cd4 count under 350 * diagnosis of aids * diagnosis of anorexia * problematic substance use, as defined by a mental health provider * psychiatric instability, as defined by a mental health provider

Keywords: medical co-morbidity diabetes heart disease respiratory illness
non-risk based lang cancer screening with a one-off ldct

Conditions: Lung Cancer

Summary: guangzhou lung-care project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of lc, recruiting residents aged 40-74 years from four communities in guangzhou between 2015 and 2021.the primary outcome was lc detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage i lc cases, and to investigate the various factors associated with the development of lc.

guangzhou lung-care project is a single-arm, prospective cohort study using one-time low-dose computed tomography for the early detection of lc, recruiting residents aged 40-74 years from four communities in guangzhou between 2015 and 2021. follow-up for post-screening management and survival was recorded. the primary outcome was lc detection rate in eligible participants without restrictions based on high-risk factors and the proportion of stage i lc cases, and to investigate the various factors associated with the development of lc. additionally, we compared the detection rates of lc and the proportion of stage i lc cases between "high-risk" and "non-high-risk" groups according to the national comprehensive cancer network (nccn) guidelines and chinese guideline.

Eligibility criteria:
inclusion criteria: * minimum age of 40 years among the residents in guangzhou exclusion criteria: * persons who had a diagnosis or treatment related to lc within the past 5 years, had undergone chest ct within the past year, or had significant cancer-related symptoms (e.g., hemoptysis, dyspnea, inability to climb two flights of stairs).

Keywords: screening
safety and efficacy study of mix vaccine in breast carcinoma patient

Conditions: Breast Neoplasms

Summary: the purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (mv). enrolled patients will receive standard treatment according to national comprehensive cancer network (nccn) guide line with or without combining mv injection. the efficacy and side effect will be compared between the two groups.

in the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. in the control arm patients will be receiving standard therapy according to national comprehensive cancer network (nccn) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (mv). mv will be injected weekly till disease progression. blood sample will be obtained at baseline and every week before mv injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). patients will be evaluated for toxicity throughout the study. side effect, progression free survival, immunology index and general status will be recorded.

Eligibility criteria:
inclusion criteria: * 1.patients diagnosed with breast carcinoma based on histology * 2.evaluable lesions on imaging study * 3.without known immunodeficiency * 4.age \>18 and \<80 years ago exclusion criteria: * 1.patients is unable or unwilling to sign informed consent * 2.any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication * 3.positive hiv and/or rpr (rapid plasma reagin) * 4.female patient who is pregnant or breast feeding * 5.patients, based on the opinion pf the investigator, should not be enrolled into this study * 6.prior anti-cancer vaccine or biological immunotherapy * 7.allergic to any known ingredient of the mv compound

Keywords: mix vaccine, breast neoplasms, immunotherapy
cardio-respiratory response of a training session versus an adapted physical activity session

Conditions: Pulmonary Disease

Summary: the aim of this study is to show that training session with nintendo wii requires the same cardiorespiratory demand than training session on ergocycle or treadmill, traditionally used in pulmonary rehabilitation program.


Eligibility criteria:
inclusion criteria: * patients with pulmonary disease exclusion criteria: * exacerbation of the pulmonary disease * weight \>150kg * refusal to participate * people in pre and post surgical rehabilitation

Keywords: pulmonary rehabilitation exercise physical activity
evaluating sexual function in women undergoing a radical cystectomy for bladder cancer

Conditions: Bladder Carcinoma

Summary: this study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. a radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. this may affect sexual function in women. this study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.

primary objectives: i. to characterize pre-operative sexual function and interest in sexual activity of women undergoing radical cystectomy. ii. to identify patient understanding and expectations as they relate to sexual dysfunction after radical cystectomy. iii. to describe pre-operative importance in sexual function recovery after radical cystectomy. iv. quantify the changes in sexual function within the year following radical cystectomy in women. v. explore the effects of age, baseline sexual function, general quality of life, parity, menopausal status, hormone replacement therapy (topical versus \[vs.\] oral), general and cancer related quality of life, chemotherapy (neoadjuvant vs. adjuvant), treatment-related complications and performance status on sexual function outcomes. vi. explore the effects of robotic vs. open approach, extracorporeal vs. intracorporal approach, organ-sparing (ovaries, uterus, cervix, anterior vaginal wall), type of vaginal closure (vertical vs. horizontal), nerve sparing, urinary diversion type (ileal conduit vs. neobladder vs. continent cutaneous diversion) on sexual function outcomes. vii. quantify the changes in sexual activity interest within the year following radical cystectomy. outline: patients complete surveys over 15-20 minutes at baseline and at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * adult women greater than 18 years of age * a diagnosis of bladder cancer * planned to undergo a radical cystectomy * willing and able to complete survey questionnaires exclusion criteria: * inability to provide informed consent * non-english speaking * life expectancy less than 2 years
protect : pacing to protect heart for damage from blocked heart vessel and from re-opening blocked vessel(s)

Conditions: Acute Myocardial Infarction

Summary: to determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

to determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myocardial infarction, requiring pci within 2 to 6 hours following symptoms * total occlusion of a coronary artery with reference vessel diameter \>or= 3mm exclusion criteria: * thrombolitics * severe bradycardia requiring cardiac pacing * previous pci or cabg * recent stroke or cv surgery * recent major surgery or trauma * clinical and hemodynamic unstability * implanted crm device * evidence of previous mi * diabetes using rosiglitazone or other fibrates * permanent af * mechanical tricuspid valve * pregnancy * exclusion for mri * incapability of participating in exercise test
healing hearts of hospitalized patients

Conditions: Pain; Anxiety; Stress; Loneliness

Summary: the study aims to investigate therapeutic virtual reality (vr) facilitation with adult inpatients using vr as an analgesic and anxiolytic during their hospitalization. specifically, this study will evaluate the outcomes of patients who experience therapeutic vr with and without a trained facilitator as a form of escapism.


Eligibility criteria:
inclusion criteria: * adults aged 18 years and above * able to provide informed consent * able to follow commands * adequate motor skills for upper extremities to operate vr equipment * clinically stable * experiencing anxiety related to their medical condition as evidenced by a vas-a score \>4 at time of enrollment. * english speaking * willing to engage in therapeutic vr exclusion criteria: * severe cognitive impairment * facial trauma prohibiting headset use * physical limitations in facial, neck, upper extremities that hinder use of vr equipment * aggression or violence * harm to self or others * isolation room * history of seizures or other neurological conditions * severe motion sickness * active nausea * severe visual impairment * severe cognitive impairment

Keywords: virtual reality
analgesic ointment on temporomandibular joint and masticatory muscle pain

Conditions: Temporomandibular Disorders

Summary: the purpose of this study is to compare the effectiveness of using topical cream of ping on ointment and using vaseline cream in the treatment of temporomandibular joint (tmj) and masticatory muscle pain, in order to establish the true efficacy of ping on ointment. both ping on ointment and vaseline are considered intervention.

aims: to compare the effectiveness of using topical cream of ping on ointment and using vaseline cream in the treatment of temporomandibular joint (tmj) and masticatory muscle pain, in order to establish the true efficacy of ping on ointment. methods: in this randomized, double-blinded, placebo-controlled trial, 55 subjects with tmj and/or masticatory pain (group 1 patients according to the research diagnostic criteria for temporomandibular disorder (rdc/tmd) received ping on ointment for 4 weeks; or placebo for 4 weeks. subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.

Eligibility criteria:
inclusion criteria: 1. self report of facial ache or pain in the muscles of mastication, the tmj, or the region in front of ear or inside the ear 2. positive clinical diagnosis of tmds. the tmd diagnosis is classified using axis i of the research diagnostic criteria ( rdc) for tmds. the rdc diagnosis consists of joint pain at rest ( spontaneous pain) and evoked pain (hyperalgesia) on palpation of the tmj, tmj reduction consists of reciprocal clicking or joint noise with mandibular movement examination. 3. for joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly-daily pain. 4. subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with tmds are known to exhibit muscle pain secondary to their joint dysfunction. exclusion criteria: 1. subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the rdc; 2. subjects with pain attributable to confirmed migraine or head pain condition other than tension headache; 3. subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months; 4. subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain; 5. subjects who are not competent in giving consents. 6. pregnant or lactating women 7. subjects with sensitivity to the ingredient of ping on ointment will be excluded.
portal blood flushes in the peri-reperfusion stage of liver transplantation

Conditions: Liver Disease

Summary: by showing that increased levels of acidotic metabolites and electrolytes in the systemic blood of patients who do not receive portal blood flush prior to reperfusion compared to patients who do receive portal blood flush, and that these increased levels correlate with cardiac depression as seen on tee, the investigators hope to find a superior technique for liver reperfusion.


Eligibility criteria:
inclusion criteria: * liver transplantation * 18 years old or older exclusion criteria: * none
relationship between oral dmt burden and adherence in ms

Conditions: Multiple Sclerosis; Adherence, Medication

Summary: stature is a prospective observational six-arm translation multi-site study that will run for approx. 4.5 years. the primary aim is to measure treatment burden and its relationship to medication adherence across six self-administered oral disease-modifying therapies (cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, and diroximel fumarate) in multiple sclerosis (ms). the information gained will assist prescribing decision-making; accounting for medication burden at a patient level and potential implications on medication adherence and persistence, thus minimising primary and secondary healthcare costs. three-hundred and twenty-three individuals with ms will be recruited into the study. patient-reported outcome measures will be administered via qualtrics, a secure online data collection tool. medicare and pharmaceutical benefits scheme (pbs) data will also be collected.


Eligibility criteria:
inclusion criteria: * 18 years or older. * a confirmed diagnosis of multiple sclerosis. * commencement (switching or newly prescribed) of one of the 6 following dmts within the previous 2-months: cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, diroximel fumarate. * able to read and write in english. * access to an internet connection and computer facilities, required to complete assessments. exclusion criteria: * use of any other dmt than cladribine, dimethyl fumarate, fingolimod, teriflunomide, ozanimod, diroximel fumarate. * comorbid neurological condition. * severe cognitive or psychological dysfunction deemed to interfere with the person's ability to undertake study requirements, as determined by their ms clinic treatment team (neurologist; ms nurse).

Keywords: multiple sclerosis adherence treatment burden disease modifying therapy oral cladribine dimethyl fumarate fingolimod teriflunomide ozanimod diroximel fumarate
changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction

Conditions: Meibomian Gland Dysfunction

Summary: in this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. in case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.


Eligibility criteria:
inclusion criteria: 1. age over 19 years old, with moderate to severe meibomian gland dysfunction. exclusion criteria: 1. patients with history of previous ocular or intraocular surgery 2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease 3. history of intolerance or hypersensitivity to any component of the study medications 4. wearing contact lenses during the study period, presence of current punctal occlusion 5. pregnancy, lactating women, and children

Keywords: meibomian gland dysfunction lipiview tear lipid layer