Kornimate/medical-research-clean huggingface dataset:
hearing health equity through accessible research and solutions for korean americans

Conditions: Age-related Hearing Impairment; Personal Communication; Hearing Impairment; Hearing Loss; Community-dwelling Seniors; Korean

Summary: the objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older korean americans (ka) and the older korean american's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.


Eligibility criteria:
participant criteria participant inclusion criteria * self-identified as first-generation ka in the target region * age 60 years or older * has a communication partner who lives in the same household or has at least weekly interactions * screening audiometry pure-tone audiometry (pta)1,2,4 kilohertz (khz) \>25 decibel (db) hearing loss (hl) in better ear * hearing handicap as measured by hhie-s score \>=8 participant exclusion criteria * current use of hearing aid * medical contraindications to use amplification device (e.g., draining ear) * plan to move from the area within 6 months * active treatment for a terminal illness or in hospice communication partner criteria communication partner inclusion criteria * age 18 years or older * able to read and speak korean * lives with the older adult or has at least weekly interactions communication partner exclusion criteria * plan to move from the area within 6 months * active treatment for a terminal illness or in hospice
pollinosis and exhaled breath temperature

Conditions: Pollinosis

Summary: the purpose of this study is to determine whether exhaled breath temperature, a surrogate marker of airway inflammation, rises during the pollen season in sensitized subjects with allergic rhinoconjucnctivitis with or without mild asthma. sublingual immunotherapy with respective allergens suppresses the seasonal increase of ebt. during the second year (2013) of the trial all patients will be treated with 5 grass allergen extract: carry over differences between the active and placebo arms from the previous year (2012) will be looked for.

patients with grass pollen allergy are most typical and best responding to sublingual immunotherapy. their selection will be done in accordance with the criteria listed in chapter 9 of the world allergy organization position paper on specific immunotherapy 2009 and in compliance with the rules for good clinical practice. proposed primary variable: the difference between the changes of exhaled breath temperature before and in the pollen season of subjects treated with grass-pollen sublingual immunotherapy and the untreated control patients. suggested secondary variables: changes over time of exhaled breath temperature in the two groups, difference in symptoms scores, methacholine responsiveness, rescue medication usage. statistical analysis: on the basis of the available data about the variability of exhaled breath changes and its changes upon flare up of airway inflammation or after anti-inflammatory treatment we have calculated a sample size of 20 subjects in each group to be sufficient to prove differences in the primary variable with a significance level \<0.05. however, as this is "first time ever" type of pilot study on sublingual immunotherapy and exhaled breath temperature in grass-pollen patients, this estimate is relative. by all means this study will identify trends to be used for sample size calculations in future studies. during the second year of the study when all patients will be on active treatment with 5 grass allergen extract, carry over effects from the first year of treatment with 5 grass allergen extract or placebo on exhaled breath temperature will be explored.

Eligibility criteria:
inclusion criteria: * 60 randomized patients from either sex * age range 5-55 years * included patients should have a proven grass pollen sensitization exclusion criteria: * age under or above the stated * lack of any other concomitant allergen sensitivities that may blur the clinical course of the natural exacerbation due to pollen

Keywords: pollinosis sublingual immunotherapy exhaled breath temperature
prevalence of tick-borne encephalitis in the pediatric population treated at the hus and characterization of confirmed pediatric cases

Conditions: Tick-borne Encephalitis

Summary: tick-borne encephalitis (tbe) is a zoonosis mainly transmitted to humans by the bite of ticks of the genus ixodes and, to a lesser extent, by the consumption of contaminated and unpasteurized dairy products. during the last decade, the epidemiology of this arbovirosis has changed profoundly with the discovery of new human cases and/or new areas of circulation of tick-borne encephalitis virus (tbev) throughout europe and particularly in france. historically, alsace is the main endemic area for this pathology in france. the pathology is notifiable since june 2021 in france. although tbev infection in children seems to lead to a milder clinical presentation, data are much less abundant than in adults and only a few cases reported in infants under 1 year old have been published. data from the most recent ecdc annual epidemiological report on tbe (2019) showed incidence rates of approximately 0.2 and 0.5 per 100,000 population in patients younger than 5 and 15 years, respectively. however, several observations may moderate and challenge both the low incidence rate and the less severe clinical presentation reported in children


Eligibility criteria:
inclusion criteria: * minor subject (≤ 16 years) * hospitalized at the university hospital of strasbourg between 01/01/2020 and 31/12/2022 * having had a csf sample taken as part of care, without infectious (other than tbe) or non-infectious etiology diagnosed * whose parental authority holders have already given their consent for their child's biological resources to be kept in the "microbiology" biocollection and reused for scientific research purposes. exclusion criteria: * patient or parental authority holders who have expressed their opposition to participate in the study * any person, male or female, over 16 years of age, * or any person, male or female, under 16 years of age, treated at the university hospitals of strasbourg from january 2020 to december 2022, who has had a csf sample taken as part of their care, for which a non-infectious etiology or an infectious etiology other than tbe has been diagnosed. * impossible to give the subject informed information (difficulties in understanding the subject, ...)

Keywords: tick-borne encephalitis (tbe) genus ixodes tbev infection tbev infection in children prevalence of tbe
a study to assess the long term effect, safety and metabolism of a solifenacin liquid suspension in participants 5 to 18 years of age with neurogenic detrusor overactivity

Conditions: Neurogenic Detrusor Overactivity

Summary: the purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (ndo) in children and adolescents.

the ndo often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. these patients often have an inability to void, so that catheterization is required to empty the bladder. the medicine being tested in this study is called solifenacin succinate. solifenacin tablets are given to adults for the treatment of overactive bladder. a new liquid suspension has been developed to treat children and adolescents in this and other studies. the efficacy and safety of the solifenacin suspension was investigated. the take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days. safety assessments included analysis of the blood and urine, review of the electrocardiogram (ecg), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).

Eligibility criteria:
inclusion criteria: * documented diagnosis of ndo, confirmed by urodynamics * practicing clean intermittent catheterization (cic) * currently on treatment with an antimuscarinic drug exclusion criteria: * known genitourinary condition (other than ndo) that may cause incontinence * bladder augmentation surgery * current faecal impaction * electro-stimulation therapy within 2 weeks prior to screening and at any time during the study * subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention * reflux grade 3 or 4 * current urinary tract infection (uti) * subject has severe renal impairment (glomerular filtration rate \< 30 ml/min) * subject has severe hepatic impairment (child-pugh score \> 9). * subject has received intra-vesical botulinum toxin within 9 months prior to screening

Keywords: cognitive function phase 3 neurogenic detrusor overactivity pharmacokinetics ocular accommodation urodynamics
immediate effect of ultrasound therapy on bilateral masseter myalgia

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: this study will compare ultrasound 0.4 w/cm\^2 and 100% duty cycle versus no ultrasound (placebo) for bilateral masseter myalgia in up to 38 adult women. the dose will be applied for 5 minutes on each side. both the dose and the starting side will be randomized. both the subject and ultrasound operator will be blind to the dose. the outcome measures will be pressure pain threshold on both masseter muscles and both temporalis muscles, self reported pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles, and intraoral temperature. these outcome measures will be taken before and after each dose, so three times per subject.


Eligibility criteria:
inclusion criteria: adult females bilateral myalgia based on diagnostic criteria for tmd (dc-tmd) (schiffman, et al., 2014) current pain intensity ≥4 out of 10, (where 0 is no pain and 10 is the worst pain ever) on both sides. exclusion criteria: history or diagnosis of systemic musculoskeletal disorders. rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). certain conditions such as neoplasms or fractures. neuropathies or neurological disorders. currently taking muscle relaxants or analgesics. any form of physical therapy within the last 60 days.

Keywords: therapeutic ultrasound
fostering resilience to psychosocial and hiv risk in indian msm

Conditions: HIV Infection; Sexual Behavior; Health Behavior

Summary: india has the world's third largest hiv epidemic and men who have sex with men (msm) are an identified high risk group. msm in india face unique psychosocial stress underlying the context of hiv risk. to maximize the potential impact of an hiv prevention intervention, the purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a behavioral intervention that addresses both psychosocial / contextual stress and reducing participant's risk for hiv.

india has the world's third largest hiv epidemic, and msm in india have an estimated seroprevalence of 14.7%. many hiv prevention efforts for msm in india are limited to condom distribution and hiv education, with no existing efficacy trials of hiv prevention interventions and therefore no evidenced based hiv prevention interventions this population. msm in india are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which potentially increases the risk for hiv transmission to their wives. this proposal is the culmination of our ongoing, successful \> 10-year community based research collaboration with two ngos dedicated to hiv prevention among msm, sahodaran (chennai) and the humsafar trust (mumbai), and investigators from the india council of medical research (icmr), national institute for research in tuberculosis (nirt) in chennai. our work, including extensive community advisory input, has identified self-acceptance as a key resilience variable that protects against both hiv risk and psychosocial distress. a field test and pilot randomized controlled trial of our behavioral intervention that addresses both hiv risk and self-acceptance showed high participant acceptability and feasibility of study procedures, and success reducing hiv sexual risk behavior. the current study is a two-arm randomized controlled trial to reduce hiv, sti and sexual transmission risk compared to hiv/sti counseling and testing alone.

Eligibility criteria:
inclusion criteria - one of the following must be true: * participant has had anal sex with 4 or more male partners (protected or unprotected) in the past 4 months. * participant has had condomless anal sex with a man who was hiv unknown or serodiscordant in the past 4 months. * participant has a history of transactional sex activity in the past 4 months. * participant has been given a diagnosis of an sti in the past 4 months. exclusion criteria: * participant does not identify as male * younger than 18 * is unable to understand or consent to the procedures * is deemed by the local pi or study staff to be engaging in deception about the inclusion/exclusion criteria.

Keywords: hiv risk behavior
feasibility study of anti-inflammatory cytokines in whole blood in osteoarthritis patients

Conditions: Osteoarthritis

Summary: this is a feasibility study to determine if anti-inflammatory cytokines can be concentrated from patients with osteoarthritis.


Eligibility criteria:
inclusion criteria: * radiographic evidence of osteoarthritis * signed informed consent exclusion criteria: * pregnancy * \< 18 years of age * blood clotting disorder or active hematologic cancer * undergoing chemotherapy * history of rheumatoid arthritis * septic joint or fracture * active infection or history of chronic infection * use of cytokine blocking drugs with the last 6 months * intra-articular steroid or hyaluronic acid (ha) injection within last 6 months

Keywords: osteoarthritis
to assess the level of adherence of subjects receiving saizen® via easypod™ in france

Conditions: Growth Disorders

Summary: this is a national, multicentre, observational registry to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment from hospitals in france and to assess the level of adherence of subjects receiving saizen® via easypod™.

subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. parents will provide their written agreement to upload their child's data in the study electronic crf. easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. adherence data will be primarily derived from injections recorded in the easypod™ device combined with physician data entry of outcome measures (i.e. height \& weight). this will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes. since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. auxological and laboratory data will be reported prospectively throughout the duration of the study. at baseline, available data can be recorded retrospectively from the subjects' medical file and easypod™ device data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to asses the impact of adherence on insulin-like growth factor-1 (igf1) ranges/levels

Eligibility criteria:
inclusion criteria: * administered saizen® via the easypod™ electromechanical device according to pediatric registered indications (growth hormone deficiency, small for gestational age, turner-syndrome or prepubertal children with chronic renal failure). * naïve subjects or already treated with saizen and easypod for maximum 1 year * male and female between 2 - 18 years of age, or over 18 without fusion of growth plates * parent's or guardian's (or subject if over 18 without fusion of growth plates) written agreement, given before entering data into the study, with the understanding that the subject or parent/guardian may withdraw agreement at any time without prejudice to future medical care. exclusion criteria: * subjects taking saizen® in whom growth plates have fused (i.e. taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the french summary of product characteristics (smpc) * use of an investigational drug or participation in an interventional clinical study

Keywords: growth disorders saizen easypod growth hormone pediatric subject
randomized trial of achieving healthy lifestyles in psych rehabilitation

Conditions: Overweight and Obesity

Summary: this study will determine whether a behavioral weight loss intervention including dietary counseling and exercise is effective in helping people with serious mental illnesses lose weight.

the objective of this study is to perform a randomized clinical trial (achieve) to definitively test the efficacy of an innovative, practical intervention to accomplish weight loss in overweight and obese persons with smi. this multi-site trial will enroll consumers with smi who attend ten psychiatric rehabilitation centers in maryland and randomize participants to the achieve intervention or control. intervention participants will receive group and individual weight loss counseling sessions and group physical activity classes. co-primary outcomes will be change in weight from baseline to 6 and 18 months.

Eligibility criteria:
age 18 and older; * overweight, defined by body mass index at least 25.0 kg/m2; * able and willing to give informed consent and participate in the intervention; * on the same psychiatric medications within the 30 days before baseline weight (dose changes allowed;) * able to attend at least 2 intervention sessions per week during initial 6-month phase; exclusion criteria * contraindication to weight loss * receiving active cancer treatment (radiation/chemotherapy) * liver failure * history of anorexia nervosa; * cardiovascular event (unstable angina, myocardial infarction) within previous 6 months; * prior or planned bariatric surgery; use of prescription weight loss medication or over-the-counter orlistat within 3 months if participant does not agree to stop taking it; * twenty pound or greater weight loss in 3 months prior to baseline, as documented by staff measurement; * inability to walk to participate in exercise class; * pregnant or planning a pregnancy during study period. nursing mothers would need approval from physician; * alcohol or substance use disorder either: 1) active and determined to be incompatible with participation in the intervention through discussion with program staff; or 2) new abstinence from alcohol or substance use disorder in past 30 days; * planning to leave rehabilitation center within 6 months or move out of geographic area within 18 months; * investigator judgment (e.g., for concerns over safety, adherence or follow-up); * weight greater than 400 pounds.

Keywords: serious mental illness weight loss
clinical observation on kuntai capsule in treating early-onset ovarian hypofunction

Conditions: Primary Ovarian Insufficiency

Summary: to evaluate the efficacy and safety of kuntai capsule alone or combined with hormone therapy in improving ovarian function in poi patients (including subclinical stage).

the study is expected to be conducted between 2021.08 and 2023.12.120 subjects with early-onset ovarian insufficiency will be randomly assigned to trial, control, or combination groups using a computer-generated randomization table.by comparing the data of primary efficacy indexes, secondary efficacy indexes and safety indexes before and after medication, the principal investigator will write and publish the paper.

Eligibility criteria:
inclusion criteria: 1. the women aged \<40 years old. 2. serum basal follicle stimulating hormone (fsh) level ≥15 iu/l at least twice inspection (two occasions \>4 weeks apart). rare menstruation or menopause for at least 4 months. 3. individuals meeting the above criteria who voluntarily consented to study participation. exclusion criteria: 1. pregnant and lactating patients; 2. patients with endometriosis, adenomyosis, endometrial lesions (submucous fibroids, endometrial polyps, etc.), hysteromyoma \> 4cm or hysterectomy; 3. patients with known or suspected breast cancer history and estrogen-dependent malignant tumor; 4. patients with personal history of venous thromboembolism (vte) or high risk of vte (including body mass index \> 30 kg/m2, smoking and family history of thrombosis); 5. patients with porphyria; 6. patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system; 7. patients who are participating in other clinical trials or have participated in other clinical trials in the past three months; 8. patients who suspect or have a history of alcohol and drug abuse; 9. patients who are known to be allergic to the test drugs or their components; 10. the researchers determined that patients are not suitable for this trial.
decision aid - extreme prematurity

Conditions: Prematurity; Decision Support

Summary: the purpose of this study is to assess in a pilot randomized controlled trial the following picot question: in parents facing extreme premature delivery, does the use of an existing validated visual decision aid as compared to standard counseling, reduce the primary outcome of parental decisional conflict? furthermore, is such a decision aid understood and applicable across differing populations of different ethnic backgrounds and social classes?


Eligibility criteria:
inclusion criteria: * physicians who counsel women at the limits of viability * women who are receiving counseling at the limits of viability exclusion criteria: * known congenital malformations or lethal anomalies, still birth in which the fetuses' death was known before labor.

Keywords: counseling limits of viability