Kornimate/medical-research-clean huggingface dataset:
treatment of onychomycosis with loceryl (amorolfine) nail lacquer 5% versus ciclopirox nail lacquer

Conditions: Foot Dermatoses

Summary: the main objective of this study is to compare subject's compliance and satisfaction for two modes of treatment of toenails infection (onychomycosis) with loceryl nail lacquer (loceryl nl) and ciclopirox nail lacquer (ciclopirox nl).

a total of 20 subjects are to be included in 1 site in germany. methodology: subjects will receive the following treatments on the right or left toenails: * loceryl nail lacquer to be applied once weekly for 12 weeks on all affected toenails of one foot. * ciclopirox nail lacquer to be applied once daily for 12 weeks on all affected toenails of the opposite foot.

Eligibility criteria:
inclusion criteria: * subject with clinically distal and lateral subungual onychomycosis (dlso) due to dermatophytes and/or yeast (including candida) on at least one toenail of each foot at screening visit, * subject with less than 80% of the nail surface area with disease involvement and without matrix involvement, no dermatophytoma, streaks (spikes) or subungual hyperkeratosis \> 2mm, * subjects with positive mycological results (direct microscopy and culture) for dermatophytes and/or yeasts (including candida) at baseline, * subjects with same number of affected toenails on both feet or no more than one additional affected toenail on one of the feet, exclusion criteria: * subject with a surgical, medical condition or clinically important abnormal physical findings, which, in the judgement of the investigator, might interfere with interpretation of the objectives of the study (i.e. lack of autonomy), * subjects with post-traumatic nail, lichen planus, eczema, psoriasis, or other abnormalities of the nail unit, which could affect/influence the subject's compliance of the investigational products, or mask the effects of treatment (cure), * subjects with known immunodeficiency, radiation therapy, immune suppressive drugs.

Keywords: onychomycosis
pharmacometrics to advance novel regimens for drug-resistant tuberculosis-pandrtb tuberculosis

Conditions: Multi-drug Resistant Tuberculosis

Summary: pandrtb is a study of the pharmacokinetics(pk) and pharmacodynamics(pd) of bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin, levofloxacin and pyrazinamide used in novel combinations to treat multidrug-resistant tuberculosis(mdr-tb).

pandrtb is an observational study nested in the endtb (a randomized study that will evaluate five 9-month, injectable-sparing regimens) and endtb-q (and rct evaluating a 4 drug oral regimen given for 6 or 9 months) trials. these trials are providing evidence to support the transformation of mdr-tb treatment. as part of pandrtb: the plasma concentrations of the experimental arm drugs (the new and repurposed drugs bedaquiline, delamanid, clofazimine and linezolid, as well as levofloxacin, moxifloxacin and pyrazinamide) will be measured; mics will be determined in baseline isolates; and mgit cultures, additional to those in the endtb study, will be performed at weeks 6 and 10. nonlinear mixed-effects models will describe the population pk of the drugs and a pharmacodynamic (pd) model of treatment response of mycobacterium tuberculosis(mtb) load over time. recursive partitioning methods will evaluate baseline mics and pk measures as drivers of treatment response (as described by the parameters of the pd model of initial treatment response of mtb load over time, and the endtb trial endpoints: time to culture conversion, longer-term outcomes, and acquisition of phenotypic resistance). thus the key drugs and plasma drug exposure thresholds for activity will be defined, and exposure-dependent synergy or antagonism identified. the risks of toxicities (as assessed in the endtb study) will be estimated, by plasma drug exposure and important comorbidity (including hiv infection). in this way, the pk-efficacy and pk-toxicity analyses will allow definition of target plasma drug exposures. simulations will predict optimal doses. to advance the understanding of drug penetration, we will develop approaches to measure free drug plasma concentrations. drug-drug interactions will be described. thus pandrtb will inform how best to use these new and repurposed drugs in combination, to create the most effective and least toxic regimens while minimizing the development of further drug resistance.

Eligibility criteria:
inclusion criteria: all patients enrolled to the experimental arms of the endtb study and provide their written informed consent to participate in the pandrtb study. exclusion criteria: -

Keywords: mdr
detection of patients with abnormal water distribution based on bioelectrical impedance analysis (bia)

Conditions: Kidney Diseases

Summary: the aim of this clinical investigation is to prove that the seca mbca detects dialysis patients with abnormal water distribution correctly. abnormal high water distribution is defined as more than 2 liters of total body water (tbw) above a normal value range. tbw and extra cellular water (ecw) are calculated with prediction equations for healthy subjects generated in bca-01. the results are compared with tbw and ecw ascertained by dilution methods as standard reference methods. the bioelectrical impedance analysis (bia) method should be evaluated to the accuracy of the absolute measurement of the volume state of dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.


Eligibility criteria:
inclusion criteria: the study will cover 50 adults. men and women in an age range of 18 to 65 years and a body mass index (bmi) range of 18.5 to 35 kg/m2 should be equally distributed. subjects have to be patients with chronic kidney failure taking dialysis treatment. 25 patients are taken before and another 25 patients after this treatment. patients that are taken before dialysis treatment should have been dialysed two and not three days before. exclusion criteria: * amputation of limbs * gastrointestinal tract illnesses that influence the absorption of substances that are needed for dialysis * bed-ridden patients patients with clinical relevant hypervolaemia or hypovolaemia * electrical implant as cardiac pacemaker * insulin pumps * pregnancy or breastfeeding period * subjects who cannot provide an informed consent form (icf) by themselves * subjects who might be dependent from the sponsor or the investigation site
motor impairments in children with autism spectrum disorder: a multimodal approach

Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Intellectual Disability

Summary: the general goal of the present proposal, progetto mosaico, is the identification of a multimodal panel of neuropsychological, kinematic, neurophysiological, and genetic markers associated with motor abnormalities present in asd.


Eligibility criteria:
inclusion criteria: * having a clinical diagnosis of neurodevelopmental disorders (either asd, adhd, or intellectual disability) according to dsm-5 criteria; * children with typical development are also recruited from the general population by local pediatricians or from kindergartens/schools sited near our institute exclusion criteria: * using any stimulant or non-stimulant medication affecting the central nervous system * having an identified genetic disorder * having vision or hearing problems * suffering from chronic or acute medical illness.
the baltimore hears pilot study

Conditions: Age-related Hearing Impairment 1; Personal Communication

Summary: the primary purpose of the study is to develop and test the preliminary efficacy of a first-in-kind community-based intervention to provide affordable, accessible and effective hearing health care to low-income, minority older adults.

age-related hearing impairment is strongly associated with poorer communicative functioning and social isolation, but hearing impairment often goes undiagnosed and untreated, particularly among minority and low-income older adults. novel interventions that translate research on social engagement, minority health, and hearing technology are needed to expand delivery of hearing health care to underserved older adults. the baltimore hearing equality through accessible research and solutions (hears) project will develop and pilot a first-in-kind community-based intervention to provide affordable, accessible, and effective hearing health care to minority and low-income older adults and their communication partners. the study will follow a mixed-methods approach that will incorporate quantitative and qualitative components throughout the formative and evaluative processes. participants and their communication partners will be randomized to an immediate treatment group or a 3-month delayed treatment group. the investigators hypothesize that the intervention is associated with increased social engagement and communication, improved quality of life, and decreased loneliness and third-party disability in the immediate treatment compared to the delayed treatment group.

Eligibility criteria:
inclusion criteria: * age 60 years or older * english-speaking * aural-oral verbal communication as primary communication modality * post-lingual hearing loss * does not currently use a hearing amplification device or hearing aid * signed informed consent to participate in baseline, 1 month, and 3 month assessments * have a communication partner able to accompany them to all study-related appointments exclusion criteria: * individuals who do not fulfill inclusion criteria * score ≤ 25 on the montreal cognitive assessment
study to investigate effects of cal-263 in subjects with allergic rhinitis exposed to allergen in an environmental chamber

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to determine the safety and effect of cal-263 in subjects with allergic rhinitis.

a phase i, randomized, double-blind crossover study of cal-263, an oral inhibitor of pi3k delta, in patients with allergic rhinitis.

Eligibility criteria:
inclusion criteria: 1. age \>18 and \<55 years 2. has a history of seasonal allergic rhinitis for at least 2 years 3. has sensitivity to grass pollen demonstrated by a positive response to skin prick testing 4. has a positive radio allergen sorbent test (class 2 or greater) for grass pollen during the previous 12 months or at screening 5. is otherwise healthy 6. is able to provide written informed consent exclusion criteria: 1. is a female of childbearing 2. history of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis 3. history of nonallergic rhinitis, chronic sinusitis or severe asthma 4. has a nasal condition likely to affect the outcome of the study 5. is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies 6. has taken a prohibited medication within the specified interval prior to visit 1

Keywords: allergic rhinitis allergy phosphatidylinositol 3-kinase
efficacy of radiofrequency micro needling for the treatment of melasma in skin of color.

Conditions: Melasma

Summary: the objective of this study is to test the effectiveness of radiofrequency microneedling (rfmn) as a treatment for melasma. the investigator hypothesize that rfmn will be an effective treatment for melasma in skin of color patients.

the target population is skin of color patients with melasma. patients will receive 3 consecutive rfmn treatments over a period of three months. baseline melasma severity will be measured by the modified melasma area and severity index (mmasi) score. endpoints will be mmasi scores at 1 and 3 months post-procedure. patient reported outcomes will be measured using the melasma quality of life (melasqol) validated patient questionnaire at screening and at both follow up visits. the long-term goal of future studies would be to provide melasma patients, particularly those with skin of color, with improved therapeutic options for the treatment of their melasma, as compared to current treatment options.

Eligibility criteria:
inclusion criteria: * males or females, at least 18 years of age * fitzpatrick skin types iv-vi * clinically diagnosed melasma * no topicals (retinol, vitamin c serum, etc) for 6 weeks before visit 1 (with exception of sunscreen) exclusion criteria: * is currently pregnant or planning to conceive during the study period * is using topical or oral therapy or other treatment for melasma
impact of decision aids on bariatric surgery choice

Conditions: Obesity, Morbid

Summary: sleeve gastrectomy, roux-en-y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. these treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. thus, shared decision making (sdm) is necessary to aid patients to choose an appropriate treatment that suits thier needs. investigators have developed a decision aids (das) and plan to conduct a randomized controlled trial (rct) to evaluate its impact on obese patients. the measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. investigators expect the das would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) ≧ 32 kg / m2 with obesity-related comorbidity 2. body mass index (bmi) ≧ 37 kg / m2 exclusion criteria: 1. endocrine system abnormalities in patients 2. drug abuse or mental illness 3. major organ dysfunction and can accept surgery 4. patients cannot understand chinese 5. age less than 20 years old or more than 70 years old
first-in-human assessment of safety, biodistribution and pharmacokinetics of 18f-fluoro-1-naphthol (18f-4fn) for pet imaging

Conditions: Endocrine Neoplasia

Summary: 18f-4fn represents a novel pet agent for imaging inflammation. acute inflammatory signaling through the tlr axis recruits neutrophils and macrophages to inflammatory sites. both cells activate the production of high energy reactive oxygen species/reactive nitrogen species (rons), setting off a cascade that can be leveraged to detect the presence of these inflammatory cells by molecular imaging. 18f-4fn is efficiently oxidized by high energy rons, leading to retention and accumulation in human neutrophil-like cells in vitro, and at the sites of acute inflammation in vivo. like 18f-fdg, 18f-4fn clears rapidly through the kidney at 1 hr following i.v. injection

objectives: primary objective: the primary objective of this first-in-human (fih) study is to determine the safety, biodistribution, and dosimetry profile of a novel positron emission tomography (pet) imaging tracer, 4-\[18f\]fluoro-1-naphthol (\[18f\]4fn), which specifically targets reactive oxygen species (ros). a currently proposed indication for this radiopharmaceutical (rp) is to non-invasively quantify inflammation by pet/ct imaging. exploratory objectives: one exploratory objective is to identify preliminary efficacy signals from pet/ct images indicating that the new radiopharmaceutical localized to known or clinically-suspected tissues or regions of inflammation mediated by innate immune-related adverse events (irae). another exploratory objective is to determine if a time point other than one-hour post injection will yield clinically meaningful improvements to imaging data.

Eligibility criteria:
inclusion criteria: * patient \>/= 18 years of age. * patients with histologic diagnosis of solid or liquid tumor treated by ici with evidence of or clinical suspicion of irae or patients with suspected inflammation. * normal range standard renal and liver function tests for age: egfr \>= 60 ml/min/1.73 m2 adequate liver function: bilirubin ≤ the upper limit of normal (uln) alkaline phosphatase, alanine aminotransferase (alt), and aspartate aminotransferase (ast) ≤ the uln exclusion criteria: * pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18f\]4fn in pregnancy are not known. urine or serum pregnancy test (female \</= 60 years of age or childbearing potential) within 24 hours of the pet scan. * subjects with contraindications to the use of \[18f\]4fn including confirmed allergy. * patients with a body weight of 400 pounds or more, or a bmi which precludes their entry into the bore of the pet/ct scanner, because the hardware is not intended to support that weight. * any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance. * children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.
the effect of cold application on pain developed due to drain removal in patients with kidney transplantation

Conditions: Pain

Summary: the study was planned as a prospective, randomized controlled study to examine the effect of cold application on pain due to jackson pratt drain removal in kidney transplant patients.

during kidney transplant surgery, a jackson pratt drain (jp) is placed in the surgical field to monitor lymphocele and urinary leakage. this drain is a closed system that opens outward from the skin at a point close to the incision line. this drain is removed by pulling when the drainage amount falls below 30 ml. this procedure is known to cause serious pain. in our study, which was planned as a prospective, randomized controlled study, it was aimed to examine the effect of cold application in the pain caused by the removal of the jp drain in patients with kidney transplantation. the population of the study will be patients who had a kidney transplant in i̇stinye university hospital liv hospital organ transplant center (n=76). in the study, patients will be assigned to the experimental and control groups by the block randomization method. "patient information form" and "visual analog scale" (vas) will be used as data collection tools. in the experimental group, cold application will be made until the skin temperature of the drain exit area reaches 13.6 °c. then, the drain removal process will be performed by the physician. in the control group, no application will be made. in both study groups before drain removal, immediately after drain removal and 15 minutes later, pain levels will be measured with vas and analgesic needs will be questioned. chi-square and t-tests will be used to compare demographic data in the analysis process of the data. anova test will be applied to compare pain scores between groups.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * being conscious, oriented to person, place and time, * no history of mental pathology, * no history of drug or alcohol use, * having a body mass index of \<30 kg/m2, * not using any analgesic or sedative medication one hour before drain removal. exclusion criteria: * iv analgesic or sedative treatment during cold application, * having a history of chronic pain, * having previous drain removal experience, * anxiety, * refusal to participate in the research, * unstable hemodynamic status.

Keywords: pain pain management kidney transplantation drainage cryotherapy
a study of an epstein-barr virus (ebv) candidate vaccine, mrna-1195, in 18- to 55-year-old healthy participants

Conditions: Epstein-Barr Virus Infection

Summary: the purpose of this study is to evaluate the safety and reactogenicity of mrna-1195 in healthy participants.

there will be 2 sequential parts to the study: * participants 18 through 55 years of age will be enrolled in part a of the study first, which will only enroll those participants who are ebv-seropositive at screening. * part b will enroll participants 18 through 30 years of age who are either ebv-seronegative or ebv-seropositive at screening.

Eligibility criteria:
key inclusion criteria: * for part a: positive ebv serostatus at screening. for part b: negative ebv serostatus or positive ebv serostatus at screening. * according to the assessment of the investigator, is in good general health and can comply with study procedures. * for participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to day 1, agreement to continue adequate contraception through 3 months following last study injection and is not currently breast/chest feeding. key exclusion criteria: * participant is acutely ill or febrile (temperature ≥38.0 degrees celsius \[°c\]/100.4 degrees fahrenheit \[°f\]) 72 hours prior to or at the screening visit or day 1. * symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). * any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * history of myocarditis, pericarditis, or myopericarditis. * participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening visit (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. topical corticosteroids and tacrolimus are allowed. * participant has received or plans to receive any licensed or authorized vaccine, to include covid-19 vaccines, ≤28 days prior to the first injection (day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed/authorized influenza vaccines, which may be received more than 14 days before or after any study injection. * participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study. note: other inclusion and exclusion criteria may apply.

Keywords: infectious mononucleosis mononucleosis virus diseases infections gamma-herpesvirus