Kornimate/medical-research-clean huggingface dataset:
study of a signal-processing algorithm aiming at improving speech-in-noise intelligibility in normal-hearing and hearing-impaired persons

Conditions: Speech Intelligibility in Noise

Summary: nearly half a billion people suffer from disabling hearing loss. the most common form of hearing loss in adults is age-related hearing loss (arhl), which causes a reduced ability to understand speech in noisy environments. the ability of people with arhl to communicate is therefore greatly impacted, limiting their social interactions and thus their quality of life. yet, the wear of hearing aids - which is the current standard rehabilitation treatment in such cases - does not lead to optimal satisfactory outcomes when it comes to understanding speech in noisy environments. the objective of this pilot study is to test a new signal-processing algorithm, based on artificial intelligence, that aims at enhancing the intelligibility of speech-in-noise signals. the efficiency of the algorithm is compared to a standard denoising algorithm commonly used in hearing aids. the primary outcome measure is the word-identification performance of the participants, using the frmatrix test (jansen et al., 2012). two secondary outcome measures are investigated: listening effort (self-assessed using a likert scale, and measured through response times), and subjective preference (assessed in a paired-comparison task). the study is conducted in 20 normal-hearing subjects and in 40 older (age ≥ 55 years) hearing-impaired subjects.


Eligibility criteria:
inclusion criteria for normal-hearing participants : * consenting to and available for the study * age ≥ 18 years and ≤ 25 years * right-handed * native french speaker * pure-tone air-conduction audiometric thresholds at .5, 1, 2, and 4 khz all ≤ 20 db hearing loss (hl) exclusion criteria for normal-hearing participants : * score at the tinnitus handicap inventory \> 56 * uncorrected visual impairment * pregnancy * subject placed under legal authority (guardianship, tutorship) inclusion criteria for hearing-impaired participants : * consenting to and available for the study * age ≥ 55 years * native french speaker * pure-tone air-conduction average hearing thresholds (pta) for frequencies of .5, 1, 2, and 4 khz ≥ 30 db hl and ≤ 70 db hl * right-ear pta for low frequencies (\ 4 khz). the difference between the two ptas must be ≥ 20 db * the difference between the pta for frequencies of .5, 1, 2, and 4 khz (pta.5-4khz) in the right ear and the left-ear pta.5-4khz must be ≤ 10 db exclusion criteria for hearing-impaired participants : * score at the tinnitus handicap inventory \> 56 * history of a hearing impairment that was left uncorrected for more than 10 years * uncorrected visual impairment * congenital hearing impairment * ménière's disease * auditory neuropathy * mixed hearing loss * fluctuating hearing impairment * sudden hearing loss * hearing impairment concomitant with other symptoms (e.g. vertigo) * score at the montreal cognitive assessment (moca) \< 27 * subject placed under legal authority (guardianship, tutorship)
use of honey for pressure ulcers in critically ill children

Conditions: Bed Sore; Pressure Ulcer; Pressure Sore; Critically Ill Children

Summary: the enrolled children would be randomized to one of the groups 'study group' or 'honey dressing group' or 'group i' (honey dressing containing active leptospermum honey also known as manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage iv ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'standard treatment group ' or 'group 2' (paraffin gauze is applied after application of povidone iodine). randomization will be performed as per protocol. primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure and new onset infection of ulcer.

children admitted to the picu would be eligible for inclusion. the interventions will be initiated within the hospital itself. all children will be managed as per standard treatment protocols of the unit for various disease conditions. the enrolled children would be randomized to one of the groups 'study group' or 'honey dressing group' or 'group i' (honey dressing containing active leptospermum honey also known as manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage iv ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'standard treatment group ' or 'group 2' (paraffin gauze is applied after application of povidone iodine). randomization will be performed as per protocol. primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure rate and new onset infection of ulcer. the investigators icu is a fully equipped 8 bedded icu with all ventilated beds. there are 2 full time consultants, residents and staff with nurse patient ratio of 1:1 to 1:2. therefore, the investigators are well equipped to treat critically ill children. there will be an in-built mechanism of assuring quality of processes at different steps.

Eligibility criteria:
inclusion criteria: * all children aged \<17 years admitted to the icu and developing any stage of pressure ulcer due to mechanical pressure or device related pressure during the picu stay will be eligible for the study exclusion criteria: children with pressure ulcers and * who are on more than 1 inotrope would be excluded. * having signs of acute wound infection, * having wounds with \> 5 cm diameter, * having allergy to honey and not willing to give consent would be excluded.
to evaluate hallux terbinafine subungual gel (hsg) in the treatment of onychomycosis

Conditions: Onychomycosis of Toenail

Summary: the key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug hallux terbinafine subungual gel (hsg) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (dlso).

primary efficacy: to identify patients achieving complete cure in the target toenail at week 52. secondary efficacy: to identify patients that have achieved 1) clinical cure, 2) mycological cure, and/or 3) positive response in the target toenail at week 52. plasma pharmacokinetics: to characterize concentrations of terbinafine and major metabolite in a subpopulation of patients over the study period. nail pharmacokinetics: to characterize concentrations of terbinafine and major metabolite in distal nail clippings in patients over the study period. hsg safety and tolerability profile: to establish from plasma pharmacokinetics, related adverse events, treatment site reactions, pain, clinically significant changes in medical condition and/or medications, and clinically significant changes in liver function, serum chemistry, urinalysis, and complete blood count over the study period. subungual topical procedure: to establish the ease and durability of once monthly and once bi-monthly hsg subungual topical treatments, the investigator will record at selected time points 1) nail measurements indicating progressive clearing, 2) the ease and depth of each topical administration, 3) the investigational drug volume administered each treatment, and 4) patient tolerability.

Eligibility criteria:
inclusion criteria: * male and females 18 - 75 years of age inclusive * patients with dlso of at least one great toe * patients with dlso in the target toe confirmed by positive koh and positive fungal culture for dermatophytes * willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period exclusion criteria: * history of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition * any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the dlso infection is achieved * participation in another clinical study of an investigational drug or device within 3 months of screening * no administration of oral terbinafine or another oral antifungal within 6 months of screening * no topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening * no uncontrolled diabetes mellitus * no severe psoriasis or severe atopic dermatitis other protocol-defined inclusion/exclusion criteria may apply

Keywords: onychomycosis
study of nm8074 in patients with immunoglobulin a nephropathy (igan)

Conditions: IgA Nephropathy

Summary: this is a phase ii, open-label study designed to to evaluate the safety and efficacy of nm8074 in reducing proteinuria relative to baseline in igan patients after 99 days of treatment.

the proposed study, nm8074-igan-601, will enroll a planned total of 10 patients as subjects for the trial. all subjects will be administered 17 mg/kg of nm8074 intravenously every week, for a total of 15 doses from day 1 to day 99 of the treatment period.

Eligibility criteria:
inclusion criteria: * male and female patients ≥18 years of age at the time of consent. * a body mass index (bmi) within the range of 15 - 38 kg/m2. bmi = body weight (kg) / \[height (m)\]2. * confirmation of iga nephropathy verified by biopsy performed within the previous three years. * all patients must be vaccinated prior to dosing with menacwy menactra® polysaccharide diphtheria toxoid conjugate vaccination against neisseria meningitidis serogroups a, c, y, and w-135. menb meningococcal serogroup b vaccine (bexsero®) will be administered per local guidelines. * hemoglobin ≥ 10g/dl and platelet count ≥ 100,000/mm3 * female and male participates must agree to use contraceptives exclusion criteria: * evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than igan at screening and before dosing with nm8074. * require dialysis or plasma exchange within 12 weeks prior to screening. * presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy. * history of bone marrow, hematopoietic stem cells, or solid organ transplantation. * use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 3 months to study day 1 whichever is longer. * severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (ckd stage 4, chronic dialysis). * clinically significant abnormal ecg during screening. * currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections. * has a currently active or known history of meningococcal disease or n. meningitidis infection. * clinically significant medical or psychological conditions or risk factors that, as per the investigator's judgment, could hinder the patient's participation in the study, introduce additional risks for the patient, or complicate the evaluation of the patient or study outcomes. * pregnant, planning to become pregnant, or nursing female subjects. * females with a positive pregnancy test result at screening or on day 1.
photodynamic therapy using porfimer sodium in treating patients with non-small cell lung cancer and bronchial disease

Conditions: Lung Cancer

Summary: rationale: photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. when the drug is active, cancer cells are killed. this may be effective against non-small cell lung cancer. purpose: this clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and bronchial disease.

objectives: primary * to test the hypothesis that the immune response in non-small cell lung cancer patients treated with photodynamic therapy (pdt) is t cell mediated. secondary * to test the hypothesis that pdt potentially affects survival rates in these patients. * to test the hypothesis that t lymphocytes mediate an immune response that affects survival in pdt treated patients. outline: patients deemed suitable for photodynamic therapy (pdt) are offered pdt. patients are divided into 2 groups according to whether or not they receive pdt. all patients are referred to radiation and medical oncology for standard of care adjuvant therapy (beginning after completion of this study). * group 1 (pdt): patients receive porfimer sodium iv over 3-5 minutes and undergo irradiation with red light 48 hours later. patients receive 2 more treatments at 2-day intervals. * group 2 (non-pdt): patients undergo a baseline bronchoscopy and a repeat bronchoscopy at 4 weeks. blood sample, bronchoalveolar lavage fluid, and tumor tissue are collected after each treatment (group 1) or at time of each bronchoscopy (group 2) and assayed for the presence of lymphocyte phenotypes th1, th2, treg, and th17. after completion of study therapy, patients are followed at 1 month after pdt and then every 3 months for 3 years.

Eligibility criteria:
inclusion criteria: * patients that have a diagnosis of non-small cell lung cancer, of any stage, with obstructive or hemorrhagic endobronchial disease receiving pdt treatment. exclusion criteria: * patients that have undergone pdt, chemotherapy or radiation therapy within the past 3 months will not be considered for enrollment. * patients taking antioxidant therapy will be excluded from enrollment due to potential interaction with the potential oxidative mechanism of action of photofrin®. these antioxidants would include beta-carotene, lutein, lycopene, selenium, vitamin a, vitamin c, vitamin e.

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer recurrent non-small cell lung cancer
dopamine receptor agonist therapy for pain relief in women suffering from endometriosis: a pilot study

Conditions: Endometriosis

Summary: the proposed pilot study will estimate the efficacy and safety of a novel therapeutic agent, cabergoline, with a clinical standard therapy, norethindrone acetate, for the treatment of endometriosis-associated pain in young women with endometriosis.


Eligibility criteria:
inclusion criteria: * surgically confirmed endometriosis * age between 15-40 y, and premenopausal * pelvic pain score ≥3 on a visual analog scaleover the last month exclusion criteria: * use of other concurrent hormone medications (such as birth control pills) * impaired liver function (alt \> 2x normal) or liver disease (cirrhosis, hepatitis) * pregnancy * breast cancer * active thromboembolic disease * uncontrolled hypertension, history of cardiac valve disorder, history of fibrotic disorders
a study of intravenous mk-8226 in participants with moderate-to-severe atopic dermatitis (mk-8226-003)

Conditions: Atopic Dermatitis

Summary: this is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of mk-8226 in participants with moderate to severe atopic dermatitis. part 1 (multiple rising dose study) objectives were to find the maximum tolerated dose (mtd) of mk-8226 and to assess safety and pk. part 2 objectives were to determine safety, pk, and preliminary efficacy. part 3 objectives were to further define safety and pk, and explore mk-8226 pk/pd to model the optimal dose range for future studies. the study was terminated early due to business reasons on 08 may 2014; final results from an analysis for part 1 (efficacy, pk, safety, immunogenicity) and part 2 (safety, immunogenicity) are summarized.

part 1 of the study is a multiple rising dose assessment of the safety, tolerability, and pharmacokinetics of mk-8226 for a period of 12 weeks followed by a 20-week off-treatment follow-up period. part 2 of the study is an assessment of the safety, tolerability, and efficacy of mk-8226 for 12 weeks followed by a 20-week off-treatment follow-up period. in part 3 of the study, participants will be treated with mk-8226 for a period of 12 weeks followed by a 20-week off-treatment follow-up period to evaluate pharmacokinetic and pharmacokinetic correlations to assist with modeling the dose range planned for further studies.

Eligibility criteria:
inclusion criteria: * body weight \>=40 kg * clinical diagnosis of atopic dermatitis for at least 6 months prior * candidate for systemic or phototherapy (i.e., failed topical treatment) * moderate-to-severe disease as defined by body surface area (bsa) ≥10%, easi ≥12, and iga ≥3 * no clinically significant abnormality on electrocardiogram * no history of active or latent tuberculosis (tb) and no signs or symptoms suggestive of tb * no history of active or latent tb and no signs or symptoms suggestive of tb * history of inadequate response to a stable (≥ 1 month) regimen of topical corticosteroids or calcineurin inhibitors within 3 months before the screening visit exclusion criteria: * concurrent significant skin disease * any significant organ dysfunction within 6 months prior * history of clinically significant heart disease * history of neoplastic disease * positive for hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * infection requiring oral antibiotics within 2 weeks prior * receipt of a live virus vaccine within 4 weeks prior * inability to refrain from topical or systemic therapy during course of the study * had major surgery or donated or lost \>=1 unit of blood within 4 weeks prior * participation in another study within 4 weeks prior * current or regular user of illicit drugs or a history of drug or alcohol abuse within 1 year prior * pregnant, breast-feeding, or anticipated to conceive during the course of the study
effect of advertisements on treatment compliance in women with breast cancer

Conditions: Breast Cancer

Summary: rationale: measuring how advertising affects treatment compliance in women with breast cancer may help doctors plan the best treatment. purpose: this clinical trial is studying how advertisements affect treatment compliance in women with breast cancer.

objectives: primary * evaluate the consequences of advertisement on treatment compliance in women with breast cancer. secondary * determine the factors favoring or not favoring adherence to the medical recommendations. outline: patients and their medical and nonmedical caregivers are interviewed by a sociologist or anthropologist twice over 1 year. the first interview is at the consultation visit and the second interview is at the patient's home. the impact of advertisement on treatment compliance is measured. projected accrual: a total of 65 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * hormone receptor status not specified patient characteristics: * female * menopausal status not specified prior concurrent therapy: * not specified

Keywords: recurrent breast cancer stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
health related quality of life and multidimensional evaluations of prostate cancer subjects aged ≥ 60 years initiating gonadotropin-releasing hormone (gnrh) agonist therapy

Conditions: Prostate Cancer

Summary: the objective of the study is to compare the evolution over 6 months of health-related quality of life (hrqol) among different age groups in subjects with prostate cancer treated with gnrh agonist therapy.

relevant data collected as part of routine medical care will be captured on an electronic case report form (ecrf). investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet. this study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the ecrf.

Eligibility criteria:
inclusion criteria: * subject presenting with histologically confirmed prostate cancer * subject of 60 years and older * subject eligible to start gnrh agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study * subject giving his written consent to participate in the study * subject able to complete questionnaires exclusion criteria: * subject simultaneously participating in a clinical trial * subject who previously received a hormonal therapy during the last 6 months before inclusion
efficacy and safety of dysport® using 2ml dilution in adults with cervical dystonia.

Conditions: Cervical Dystonia

Summary: the purpose of the protocol is to evaluate the efficacy and safety of dysport® using 2 ml dilution compared with placebo for the treatment of cervical dystonia.


Eligibility criteria:
inclusion criteria: * primary diagnosis of cervical dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with botox at a total dosing range of 100-200 u and ≤60 u in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential botox treatment cycles. * twstrs total score≥ 20; twstrs-severity subscale score\> 10; exclusion criteria: * in apparent remission from cervical dystonia * diagnosis of pure retrocollis or pure anterocollis * for non-naïve subjects, previous poor response to either of the last two botox treatments * known requirement of \ 200u of botox injected into the neck muscles
proof of concept (poc) study of the soliton's acoustic scar reduction (asr) treatment for the treatment of keloid scar

Conditions: Keloid Scar

Summary: to evaluate the safety, and efficacy of the asr device for the temporary improvement in the appearance of a keloids.

to evaluate the safety, and efficacy of the asr device for the temporary improvement in the appearance of a keloids. to demonstrate improvement in the keloid scars, without unexpected adverse events (uaes) and serious adverse events (saes) directly attributable to the asr device or treatment.

Eligibility criteria:
inclusion criteria: * male or female older than 18 at the screening visit; * the participant is healthy, as determined by the investigator based on a medical evaluation including medical history; * the participant has a keloid that is easily delineated photographically located on the chest, back, trunk or upper arms and legs. * keloid size greater than 1 cm and less than 8 cm in length, with a height of at least 2 mm. * keloids less than 5 years old * body mass index (b.m.i.) is \> 20 * participant is willing to not undergo any other keloid treatments for a period of 12 months following asr treatment. * participant is willing to participate in study and adhere to follow-up schedule. * participant is able to read and comprehend english or spanish. * participant has completed the informed consent form. exclusion criteria: * participant had treatments, including topical steroids, to the keloid being treated in the study in the prior 12 months. * participant is unwilling to have research photos taken of treatment areas in the presence of sponsor's researchers. * participant is unwilling to have asr treatment provided in the presence of sponsor's researchers. * participant is pregnant or planning to become pregnant during the duration of the study. * metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, elbows, knees, etc.). * active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc. * medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.). * history of coagulopathy(ies) and/or on anticoagulant medication. * skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area. * current smoker. * any surgical procedure in the prior 3 months, or planned during the duration of the study.