Kornimate/medical-research-clean huggingface dataset:
iontophoretic transepithelial corneal cross-linking in pediatric patients

Conditions: Keratoconus

Summary: to report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (cxl) to assess preoperative factors that may influence ectasia progression

purpose: to report three year follow up in pediatric patients with keratoconus after iontophoretic transepithelial corneal cross-linking (cxl) to assess preoperative factors that may influence ectasia progression. methods: thirthyfive eyes of 22 consecutive pediatric patients (mean age 14.3±2.5 years) with keratoconus are evaluated in this retrospective study. subgroup a and b are made up in function of progression in maximum k (kmax,) defined as steepening of 1.0 diopter or more recorded three year after cxl. corrected distance visual acuity (cdva), spherical equivalent, topographic cone location, kmax, posterior elevation of the thinnest point and thinnest point are evaluated. a paired student t test is used to compare preoperative and 12, 24, and 36 month postoperative da-ta. a p value \<0.05 was considered significant.

Eligibility criteria:
inclusion criteria: clinical diagnosis of keratoconus age \< 18 years at the treatment iontophoretic corneal cross linking performed at least 3 years before exclusion criteria: age \> 18 years at the treatment i
randomized study to evaluate mace in patients with prostate cancer treated with relugolix or leuprolide acetate

Conditions: Prostate Cancer

Summary: this was a randomized study to evaluate the risk of major adverse cardiovascular events (mace) for relugolix compared with leuprolide acetate. enrollment in this study was discontinued by the sponsor on 01 dec 2023. in an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending dec 2024 if they choose to remain in the discontinuation phase of the study.

eligible patients were randomized (1:1) to receive either relugolix or leuprolide acetate for prostate cancer or as an adjunct to primary or salvage radiation therapy. the study was intended to collect clinical and cardiovascular risk factor data on patients ages 18 and older who were receiving relugolix or leuprolide acetate for their prostate cancer or as adjunct to radiation therapy with a treatment plan to be on at least 12 months of continuous adt. enrollment in this study was discontinued by the sponsor on 04 dec 2023. in an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending dec 2024. during this discontinuation phase, all active investigative sites will be expected to formulate a transition plan for their study patients from this clinical study to soc as soon as practicable. the primary endpoint in this study was the time to first adjudicated mace (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death). however, with the discontinuation of enrollment in the study on 04 dec 2023 by the sponsor, the primary endpoint will be to describe the safety of relugolix in the study population while actively enrolled patients remain on study drug.

Eligibility criteria:
a patient will be eligible for inclusion in the discontinuation phase of the study if the following applies: 1. was previously enrolled under the original version and amendment 1 of this study 2. has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study

Keywords: orgovyx relugolix prostate cancer leuprolide acetate
hepatitis b vaccination (hbv) in hiv infected children

Conditions: HIV Infections

Summary: the purpose of this study is : * to evaluate prevalence of protective hepatitis b antibody comparing intradermal (id) and intramuscular (im) route in antihbsab negative hiv infected children treated with highly active antiretroviral therapy (haart) * to revaccinate the hbv vaccine in the children who didn't have protective hbv ab

hepatitis b virus (hbv) and hiv share the same route of transmission and can have co-infection. the prevalence of this co-infection was 8.7% in thai adult\[1, 2\] and 12.1% in african hiv vertically transmitted children\[3\]. occurrence of hbv has effects to treatment due to having the same medication, lamivudine, tenofovir, emtricitabine or entecavir, to anti hiv medication. hbv can cause chronic liver disease, cirrhosis and hepatocellular carcinoma. in thailand, the routine hbv vaccination program was started since 1992. few reports in severe immune compromise hiv children has been shown to lose their expected preventive measles and hepatitis b antibody from history of scheduled vaccination even after the immune recovery by haart\[4, 5\]. limited data in of prevalence of protective hepatitis b antibody response after immune recovery in thai hiv infected children treated with highly active antiretroviral therapy. in addition, hbv revaccination in this group of children should be considered\[6\]. the response of hbv revaccination intramuscularly (im) at 0, 2 and 6 months in 63 hiv children shown response rates 17.4, 82.5, and 92.1% at 2, 6 and 7 months respectively\[6\]. protective anti-hbs were shown in the majority of non-responders to im hbv vaccine health care workers \[21/23 (91.3%)\] by two doses of intradermal route (id)\[7\]. we hypothesize to see the faster and higher response of antihbs after first dose of id compare to im in anti hbsab negative hiv infected children. no randomized control trial compare antibody response between im and id route in hiv children after immune recovery. the benefit from this trial would be decreased the vaccine cost for resourced limited country.

Eligibility criteria:
inclusion criteria: * hiv infected individuals * age 1-18 years * current cd4 within 6 months ≥ 15% or ≥ 200 cells/ml in children age ≥ 6 years * signed written informed consent * negative hbs ag, antihbs, and antihbc at screening visit exclusion criteria: * active aids * active opportunistic infection * platelet \< 50,000/ mm3 at screening visit * history of hypersensitivity to hbv vaccine * using oral steroid or immunosuppressive drugs

Keywords: hbv vaccine hiv children immune recovery hbv antibody intradermal intramuscular antibody response after hbv vaccine treatment experienced
stabilizing behavioral rhythms to improve mental health

Conditions: Depressive Symptoms; Anxiety Symptoms; Sleep Symptoms

Summary: in order to assess the efficacy of the rhythm stabilization component of healthrhythms' product, investigators will recruit 128 outpatients between the ages of 18 and 65, presenting to the university of utah department of psychiatry outpatient clinics with a current mood and/or anxiety disorder. sixty-four of these individuals will be randomly allocated to receive the full healthrhythms package (rhythm sensing, rhythm trending, and rhythm stabilization) on their smartphones, while 64 will be asked to consent to rhythm sensing only. participants in both arms will receive treatment as usual (tau) for their mood and/or anxiety disorders, as typically provided at the university of utah clinics. the duration of the study will be 16 weeks. the primary outcome measures of the rct will be the promis depression, the promis anxiety and the promis sleep disturbance computerized adaptive testing (cat) measures. the investigators hypothesize that those receiving the full package will demonstrate lower levels of depression, anxiety and sleep disturbance. in addition, investigators will explore the relationship between sensed rhythm stability and scores on patient-reported outcome measures of mood, anxiety and sleep disturbance (promis). the investigators hypothesize that positive changes in the promis measures will be mediated by positive changes in rhythm stability. the primary outcome analyses will be based on random regression models, while the mediation analyses will follow the approach described by helena kraemer and colleagues.


Eligibility criteria:
inclusion criteria: * age 18-65 * is currently in treatment for a mood and/or anxiety disorder, as defined by the dsm-5 (american psychiatric association, 2013). * patient participants need to be on a stable medication, however changes in dosage will be allowed during the course of this study * ability and willingness to give informed, written consent exclusion criteria: * severe or poorly controlled concurrent medical disorders that may cause confounding depressive symptoms (e.g., untreated hypothyroidism or lupus) or require medication(s) that could cause depressive symptoms (e.g., high doses of beta blockers or alpha interferon) * meets criteria for one of the following concurrent dsm-5 psychiatric disorders: any organic or psychotic mental disorder other than bipolar disorder, current alcohol or drug dependence, primary obsessive compulsive disorder, primary eating disorder, or antisocial personality disorder * acute suicidal or homicidal ideation or requiring psychiatric hospitalization. those who require inpatient treatment will be excluded (or discontinued) from the study and referred to for inpatient treatment. * cognitive deficits precluding use of a smartphone app and/or completion of patient-reported outcomes used at the university of utah * insufficient fluency in english, provide clear verbal feedback about problems with the app, complete the study assessments, or make use of a smartphone app that involves very minimal instructions written in english.
inner engineering online (ieo) intervention for a specific company employee program

Conditions: Burnout; Stress; Depression, Anxiety

Summary: in this randomized controlled trial; differences in overall stress, burnout and wellbeing will be assessed for employees of a company participating in inner engineering online, an online mind-body course that incorporates both meditation and yoga. the study will be conducted in two phases, where in participants will be advised to practice meditation or read books.

the benign behavioral intervention involved is inner engineering online (ieo), a mind-body course that incorporates meditation and yoga, as well as reading a book or journal of their choice.the subjects will be randomized into two groups after they agree to the participate in the study. the study will be conducted in 2 phases. phase 1: if they are in group 1, they will participate in ieo which includes practice of meditation \& yoga daily for a minimum of 30 minutes and complete a ieo activity log for 30 days.they will be asked to complete a set of questionnaires at baseline and after 30 days.if they are in group 2, they are asked to read a book or journal of their choice for 30 minutes each day for the first 30 days and complete a reading log. phase 2: after they complete reading for 30 days, group 2 participants will now participate in ieo which includes practice of meditation \& yoga daily for a minimum of 30 minutes and complete an ieo activity log for the next 30 days. they are asked to complete a set of questionnaires at baseline, 30 days, and at 60 days. these questionnaires aim to assess for burnout, stress, and well-being. these include: * maslach burnout inventory - human services survey - 16 item questionnaire measuring burnout * perceived stress scale - 10 item questionnaire measuring stress * center for epidemiology studies depression scale (ces-d) - 20 item questionnaire measuring depression * emotional distress and anxiety short form - 7 item questionnaire measuring anxiety * joy subscale of the dispositional positive emotion scale - 6 item questionnaire measuring happiness * mindful attention awareness scale - 15 item questionnaire measuring mindfulness finally, participants of both the groups will be subjected to a 30 day follow-up surveys after a month of ieo completion. they will receive a set of previously administered questionnaire and a compliance survey at this point. group 1 participants receive this survey at the 60 day time point while group 2 participants receive it at 90 days.

Eligibility criteria:
inclusion criteria: 1. age\>=18 years 2. interest in inner engineering online program exclusion criteria: 1. low english proficiency 2. not currently residing in united states

Keywords: burnout stress anxiety depression meditation inner engineering online
factors that effect the gait speed in diabetic individuals without neuropathy

Conditions: Gait Disorder, Sensorimotor; Diabetes Mellitus, Type 2

Summary: this study planned to investigate the role of potential explanatory factors effecting the speed of gait such as muscle mass, aerobic capacity, physical activity status, cognitive function, blood pressure, and metabolic measures considering age, sex, and education years in diabetic individuals without neuropathy.

type 2 diabetic people will be screened by clinical symptoms of neuropathy and dn4 questionnaire. among those who did not have neuropathic symptoms or who have dn4 score below 4 will be considered for the study.then aerobic capacity will be measured by a cycle ergometer and vo2max will be obtained. weight, body mass index and muscle mass will be measured by bioimpedance analysis. physical activity status will be determined by international physical activity score (ipaq). cognitive function will be evaluated by mini mental test. hba1c and fasting blood glucose will be measured in venous blood after overnight fasting. blood pressure will be measured in the sitting position after resting from the left arm. speed of gait will be measured by an accelerometer.then, the effect of above mentioned factors on speed of gait will be studied.

Eligibility criteria:
inclusion criteria: * individuals with diabetes mellitus less than 10 years but longer than 1 year * absence of neuropathic symptoms * dn4 questionnaire sore less than 4 exclusion criteria: individuals who had * insulin therapy, * poor glycemic control, * manifesting cardiovascular disease, * retinopathy or other visual problems, * diabetic neuropathy, * nephropathy, * cerebrovascular disease, * cognitive impairment, * heart failure, * alcohol or cigarette dependence, * cancer, * chemo/radiotherapy, * foot ulcer, * orthopedical or surgical problems * wheel-chair or any assistive devices for ambulation * prominent knee or hip arthritis, prosthesis

Keywords: mini-mental state examination gait aerobic capacity hba1c muscle hypertension glucose
the adjuvant effect of hpv vaccination on recurrence of cervical precancer or carcinoma in women undergoing conization

Conditions: Cervical Intraepithelial Neoplasia Grade 2/3; Recurrence

Summary: assessment of the association between human papillomavirus vaccination (hpv) and recurrences of cervical intraepithelial neoplasia grade 2 or worse (cin2+) in women undergoing conization.

the implementation of vaccination against human papillomavirus (hpv) in the national immunization program for the young age cohort was subsequently extended to previously unvaccinated adult women who underwent conization due to cervical intraepithelial neoplasia grade 2 or worse (cin2+). these women are offered hpv vaccination, often completed post-excision. observational and clinical studies conducted between 2010 and 2023 have demonstrated that hpv vaccination contributes to a \>70% reduction in cin2+ recurrence in women after conization. however, the outcomes of these studies have not conclusively shown whether the adjuvant effect of hpv vaccination depends on the vaccine type (bi-, quadri-, or nona-valent), the timing and completeness of vaccination, and other factors. this study aims to assess the mentioned factors and potentially reveal new ones, such as age, health status, etc. it is planned to be conducted using the laboratory records of women who underwent conization between 2010 and 2024, with their cervical screening examinations performed at the central laboratory unilabs in prague

Eligibility criteria:
inclusion criteria: * women \>18 years, with conization for cin2+ (hsil) * women who had more than one examination during a follow-up period of \>6 months. exclusion criteria: - women who underwent hysterectomy after conization. * women who had excision procedures other than cervical excision. * women who did not undergo any other cytological/histological examinations. * women with more than one conization before cin2+ recurrence

Keywords: hpv vaccination cin2+ recurrence conization
the natural history of metachromatic leukodystrophy study (home study)

Conditions: Metachromatic Leukodystrophy

Summary: the primary aims of the home study are to: * design and implement a natural history study for metachromatic leukodystrophy to serve as a source of external control data, to augment or replace concurrent controls in clinical trials; * pilot test and develop guidance on how to design, conduct, and analyze the data from a natural history study to support adaptive trial designs for regulatory use; * reduce burden of participation in trials and provide a potential solution to patient recruitment challenges, particularly for rct's; and * design approaches that support remote participation in studies.

the home study is a web-based natural history study for patients with metachromatic leukodystrophy. it is hosted by the national organization for rare disorders (nord); an independent non-profit patient advocacy organization dedicated to individuals with rare diseases and the organizations who serve them. the study collects information from participants (or their authorized respondents, heretofore referred to collectively as "participants") who are affected by metachromatic leukodystrophy. data are collected at pre-baseline, baseline, 3, 6, 9, and 12 months through online surveys, telephone interviews, web-based virtual assessments with a clinical study coordinator, and a (optional - only for u.s. residents) mobile application. data entered into this study includes name, date of birth, diagnosis, treatments, medical history, family history, quality of life, disease progression, treatment - past and proposed, general medical information, genetic test results and mutations, blood level results, upload of medical records.

Eligibility criteria:
inclusion criteria: the study is open to english speaking individuals of all ages who have a diagnosis consistent with metachromatic leukodystrophy (mld). mld is defined as: * mutations in the asa and psap genes identified by genetic testing; * a diagnosis of mld by mri of the brain; or * sulfatase enzyme activity and urinary sulfatide excretion identified by biochemical testing. exclusion criteria: patients will be excluded from the study if they do not meet inclusion criteria. * non-english speaking individuals * no confirmed diagnosis of metachromatic leukodystrophy.

Keywords: mld leukodystrophy rare disease natural history study
brain stimulation & generalized anxiety study

Conditions: Anxiety; Generalized Anxiety Disorder; Generalized Anxiety

Summary: examine the safety and effectiveness of the fisher wallace cranial electrotherapy stimulator (ces) device on generalized anxiety disorder using two (2) 20-minute per day treatment sessions over eight weeks.


Eligibility criteria:
inclusion criteria: * age greater than 21 * us resident * can receive packages to their home via ups/fedex/usps * licensed physician diagnosis of generalized anxiety disorder * beck anxiety inventory score between 8 and 25 * read/write english * have not contemplated suicide in the past year * not been institutionalized for mental health issues. * not currently experiencing problems with alcohol or drug abuse * can commit to not drinking alcohol 4 hours before bedtime for the duration of the study * can commit to two (2) 20 minute sessions per day for 8 weeks * not under medical supervision for serious medical condition * not currently being treated for or suspect a mental health issue * has not used a brain stimulation treatment in one year * no suspected or known history of heart disease * no pacemaker, or any form of medical electronics, including but not limited to a deep - brain stimulator, electronic stent, etc. * not taking opioids * are a resident of states in which we have licensed medical professionals * does not have any co-occurring significant psychiatric disorder that would impair - participant's particationion. * does not use any illicit drugs * not participating in any other anxiety study * not taking medications affecting the nervous system (e.g. psychiatric medications) * not taking hypnotics or any sleep aid or marijuana (in any form)
temporary vs.long term hemodialysis catheter on central vein stenosis

Conditions: Stenosis of Arteriovenous Dialysis Fistula

Summary: vascular access (va) is the most important for carrying out hemodialysis, yet it may bring in complications and leads to hemodialysis quality decline. this study aimed to explore the impact of vascular access types, including temporary vs.long term hemodialysis catheter on central vein stenosis.

it is unknown whether central vein stenosis occurs after temporary or long term hemodialysis catheter in long-term hemodialysis patients. this study will aim to explore this question. study design is randomized, controlled trial. one arm is temporary catheters in the internal jugular vein, and another arm is tunneled cuffed hemodialysis cather. 2\*2 is randomly distributed. the main outcome: central vein stenosis diagnosed by venography. the secondary outcome: the time of infection, and catheter patency. study period: one year

Eligibility criteria:
inclusion criteria: * need to receive long-term hemodialysis no arteriovenous shunts or immature arteriovenous shunts exclusion criteria: * uremia with heart failure or lung function failure

Keywords: central vein stenosis temporary hemodialysis catheters long term hemodialysis catheter
mirtazapine treatment of anxiety in children and adolescents with pervasive developmental disorders

Conditions: Autism Spectrum Disorders

Summary: this study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, asperger's disorder and pervasive developmental disorder.

one of the areas receiving very little attention in pervasive developmental disorders (pdds) is that of anxiety. anxiety is common in pdd, but has not yet been fully characterized. the primary objective of this study is to conduct a preliminary placebo-controlled trial of mirtazapine for the treatment of anxiety associated with pdds. we hypothesize that mirtazapine will be safe and well tolerated.

Eligibility criteria:
inclusion criteria: * ages 5-17 years * diagnosis of autistic disorder, asperger's disorder or pervasive developmental disorder not otherwise specified (pdd nos) * clinically significant anxiety as evidenced by a pediatric anxiety rating scale (pars) score of 10 or greater * abbreviated intelligence quotient (iq) greater than 50 on the stanford binet 5th ed. exclusion criteria: * diagnosis of rett's disorder or childhood integrative disorder * diagnosis of obsessive-compulsive disorder (ocd), post-traumatic stress disorder, major mood disorder, psychotic disorder, or substance use disorder * presence of any past or present medical conditions that would make treatment with mirtazapine unsafe * use of other antidepressants or benzodiazepines * use of other psychotropic medications which are ineffective, poorly tolerated, or sub-optimal in terms of dose * previous adequate trial of mirtazapine

Keywords: autistic disorder asperger's disorder pervasive developmental disorder