Kornimate/medical-research-clean huggingface dataset:
a trial to evaluate the safety and efficacy of dbi-001 gel, dbi-002 gel, and aqueous gel in subjects with onychomycosis

Conditions: Onychomycosis

Summary: this is a randomized, observer-blinded, aqueous gel-controlled trial examining the safety and efficacy of daily application of dbi-001 gel vs. dbi-002 gel vs. aqueous gel for 24 consecutive weeks in subjects with onychomycosis.


Eligibility criteria:
inclusion criteria: * 18 to 50 years of age, inclusive, at screening * willing to abstain from all cosmetic activities involving the toenails during the entire course of the study * distal subungual onychomycosis defined as a great toenail with onycholysis and thickening of the nail bed with keratinous material * willing to have his/her treatment-targeted great toenail(s) clipped to remove onycholytic nail plate at each visit * at least one treatment-targeted great toenail must have at least 6 mm of clear nail from the proximal nail fold to the proximal limit of disease and, after trimming to within 1mm distal nail groove, have at least 3mm of involved nail from distal nail groove to proximal limit of disease * confirmed presence of microorganisms of interest by koh and qpcr at screening * the affected treatment-targeted great toenail(s) is capable of re-growth as documented by subject self-reported history of clipping nails at least monthly exclusion criteria: * positive urine pregnancy test, pregnant, lactating, or female of childbearing potential who does not agree to use an active method of birth control for the duration of the study * any dermatological conditions that could interfere with clinical evaluations * great toenails with only superficial white onychomycosis, any evidence of subungual mycetoma as evidenced by yellow or white spikes, or any evidence of proximal onychomycosis * any underlying disease(s) or other dermatological condition(s) that requires the use of interfering topical or systemic therapy, with the exception of certain protocol-specified that require a defined washout period for eligibility * treatment of any type of cancer within the last 6 months, with the exception of superficial skin cancers such as basal cell carcinoma and squamous cell carcinoma * history of any significant internal disease which contraindicates the use of live microbiome * history of failing oral or prescription topical treatment for onychomycosis * a history of current episode of onychomycosis present for more than 3 years * nail or anatomic abnormalities of the target great toenail(s) * aids or aids-related complex by medical history * history of current street drug or alcohol abuse, or street drug or alcohol abuse within the past year * subjects known or suspected to be taking immune suppressive medications or subjects who are immunosuppressed * subjects with poorly controlled diabetes mellitus requiring medical intervention/treatment * subjects with peripheral vascular disease based on medical history * subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study
a novel e-health platform

Conditions: Aging Well; Decision Making; Illness, Critical

Summary: the purpose of the current trial is to evaluate a novel e-health platform. overall hypothesis: participants who receive plan well guide (pwg) 2.0 will make more progress in their 'preparations' as measured by "preparedness for the future questionnaire (prep fq)" at 6 months and, consequently, experience greater improvements in their psychological well-being (pwb), health status, and life satisfaction at 12 months compared to participants receiving pwg 1.0 (advance serious illness module only). study design: the investigators propose to conduct a multi-site randomized trial to evaluate a novel e-health platform. overall hypothesis: participants who receive plan well guide (pwg) 2.0 will make more progress in their 'preparations' as measured by "preparedness for the future questionnaire (prep fq)" at 6 months and, consequently, experience greater improvements in their psychological well-being (pwb), health status, and life satisfaction at 12 months compared to participants receiving pwg 1.0 (advance serious illness module only).study design: we propose to conduct a multi-site randomized trial. setting: several sites in lethbridge alberta. a sample of primary care clinics as well as recruit online participants. study population: the investigators plan to include interested participants that are aged between 25 to 70 years of age. we will exclude participants that don't speak english or do not have internet access/email addresses, and already have a high pwb score. study intervention: eligible participants will then be randomly allocated to 2 groups: pwg 1.0 or pwg 2.0.outcomes: the primary outcome for this trial will be an overall score of pwb questionnaire; key secondary outcomes include pwb domain scores, sf-12,single-item rating of life satisfaction, all measured at 6 and 12 months. additional outcomes include 'days off work' and health care utilization. significance: this study will be the first large multi-centre trial examining the effects of a novel e-health platform aimed at improving people's psychological well-being and health status as well as their preparedness for serious illness decision-making during this time of a global pandemic. results of this trial will likely affect the state of preparedness of individuals, and if wide disseminated, may have a dramatic effect on the health and well-being of a broad segment of the population.


Eligibility criteria:
inclusion criteria: * 25-70 years old exclusion criteria: * don't speak or read english * no home internet access * a baseline pwb score of 4.5 or greater
comparison of dialysis therapies on cognitive function

Conditions: End Stage Renal Disease; Chronic Kidney Disease

Summary: this study will evaluate the effects of more frequent dialysis on cognitive function including the assessment of sleep apnea and restless legs. our hypothesis is that more frequent dialysis improves cognitive function and may have important implications on clinical care of esrd patients and help to emphasize the need for treatments that will allow patients to live "with dialysis" rather than live "for dialysis".


Eligibility criteria:
inclusion criteria: * diagnosis of esrd * age 18 years or greater * ability to understand and a willingness to sign an informed consent statement and a health insurance portability and accountability act of 1996 (hippa) authorization statement. * expected survival of at least one year. exclusion criteria: * documented non-compliance, defined as missing more than 10% of prescribed treatments during the month prior to the start of the study.

Keywords: hemodialysis frequent hemodialysis sleep apnea restless leg syndrome cognitive function
screening donors, fecal microbiota transplant program in ulcerative colitis

Conditions: Ulcerative Colitis Flare

Summary: the investigators intend to screen for new donors, given that there may a donor effect (pubmed id: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. it is important to give uc patients participating in rcts stool that has been demonstrated to be effective in some patients. we therefore propose to conduct an open label study in patients with active uc to ensure new donors are effective at inducing remission in some patients. patients that have fmt will relapse within 18 months (pubmed id: 25857665) although further fmt therapy induces remission so it is possible that maintenance fmt will result in long term remission, but this needs evaluation. we will therefore follow uc patients that have responded to fmt long term in this open label study.

this is an open label study with all uc patients receiving fmt. up to 200 patients with active uc will be recruited to the study.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 or over 2. active uc defined as a mayo score (7) \>3 3. a mayo endoscopic score (7) \>0 4. females of child-bearing potential must be willing and able to use acceptable contraception as per appendix iii. ii. b. toxicity section of the health canada guidance exclusion criteria: 1. participating in another intervention study for uc 2. unable to give informed consent 3. severe comorbid medical illness 4. severe uc requiring hospitalization. 5. increase in medical therapy for uc in the last 12 weeks. continued treatment with 5-asa, azathioprine, 6-mercaptopurine or anti-tnf therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. stable intake of probiotic therapy also permitted. 6. antibiotic therapy in the last 30 days. 7. pregnant women. 8. patients with clinically significant hepatic dysfunction at the time of screening: alt \> 5 times the upper normal range. 9. patients with clinically significant renal dysfunction at the time of screening: serum creatinine \> 300 µmol/l 10. any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
effectiveness of aids antibody screening

Conditions: Acquired Immunodeficiency Syndrome; Blood Transfusion; HIV Infections

Summary: to determine the effectiveness of efforts to eliminate the human immunodeficiency virus (hiv) from whole blood and blood components in the blood supply.

background: in 1986, despite programs to have persons with known risk factors for exposure to the aids virus exclude themselves from the blood donating population and the universal testing of all donated whole blood and blood components for the antibody to hiv, the public was fearful of acquiring aids via transfusion and media stories increased that fear. a major concern among members of the blood banking community was the extent to which donors infected with hiv were not identified by enzyme-linked immunoassay (eia) systems. most experts believed that self-deferral and the assays for the hiv antibody were eliminating the vast majority of positive units of donated blood and blood components. if all units containing hiv were being eliminated by the combined effects of self-deferral and antibody screening (and treatment of factor viii concentrates), no recipients of only screened whole blood or blood components or factor viii would become hiv virus and antibody positive as the result of transfusion. alternately, if some hiv positive units of whole blood or blood components or factor viii concentrates were not being eliminated by self-deferral and antibody screening (and treatment of factor viii concentrates), and these units were transfused, then some transfusion recipients would become hiv antibody positive and viremic. the initiative was part of a special fiscal year 1986 national heart, lung, and blood institute aids plan. the concept was reviewed and approved by the national heart, lung, and blood advisory council in february 1986. the request for proposals was released in may 1986. two contracts were awarded in september 1986. design narrative: university of california at san francisco: a risk assessment was made of hiv infection through prospective testing for seroconversion in women recipients of anti-hiv negative blood transfusions at the university of california san francisco hospitals. blood specimens were collected from each of the recipients pre-transfusion, and at two, four, and six months post-transfusion. patients were selected based on female sex and exclusion of high risk behavior or blood transfusion during the preceding six months. johns hopkins university: the rate of seroconversion was determined in a cohort of cardiac surgery patients receiving multiple transfusions of blood products screened for hiv antibody. the study was conducted at the johns hopkins hospital, the texas heart institute, and the methodist hospital in houston. a serum sample for each patient was collected before surgery and a second sample was collected at least six months after surgery.

Eligibility criteria:
no eligibility criteria
a phase iii clinical study of mr13a9 in hemodialysis patients with pruritus.

Conditions: Uremic Pruritus

Summary: double-blind, placebo-controlled study to confirm the superiority of mr13a9 to placebo, and followed by extension, open-label treatment to confirm long-term safety of ma13a9 in hemodialysis patients with pruritus.


Eligibility criteria:
inclusion criteria: * patient with chronic kidney disease (ckd) has been on hemodialysis 3 times per week * patient receiving treatment for itch * patient has a baseline nrs score \> 4 exclusion criteria: * patient has pruritus cause other than ckd or its complications * patients has hepatic cirrhosis * patient has a known history of allergic reaction to opiates
comparison of 22-gauge and 19-gauge aspiration needle during ebus-tbna

Conditions: Lung Cancer

Summary: investigators intend to compare the 19-gauge needle and the 22-gauge-needle during ebus-tbna concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.

investigators intend to compare the 19-gauge needle and the 22-gauge-needle during ebus-tbna performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.

Eligibility criteria:
inclusion criteria: * male or female patients aged over 18 * patients signed written informed consent * mediastinal or hilar enlarged lymph nodes (\>10mm) in short axis radiological or clinical findings likely for lung cancer exclusion criteria: * severe impairment of any organs, with do not enable anaesthesia * quick \ 1,5, thrombocytes \ 120sec * other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study. * insufficient language ability (spoken and written german)

Keywords: ebus-tbna staging lymph node metastases
hormones and cognition in the menopausal transition

Conditions: Age-associated Memory Impairment; Alteration of Cognitive Function

Summary: the purpose of this study is to determine if the menopausal transition is associated with subjective and objective cognitive declines that ameliorate in menopause. the investigators hypothesize that perimenopause is associated with both subjective memory complaints and objective declines in attentionally mediated cognitive tasks. the investigators also hypothesize that this is time-limited. the investigators predict that as women transition from early perimenopause to late perimenopause their performance on attentionally mediated and verbal memory tasks will decline, and that as they transition from late perimenopause to menopause, their performance will improve.

two groups of women will be recruited, those in early perimenopause and those in mid to late perimenopause. tests of attention, working memory, mental flexibility, processing speed, and retentive memory will be administered to each subject at 6 month intervals for 5 years. additionally, women will be asked to fill out questionnaires about their mood, memory functioning, health, and quality of life. the investigators will also calculate each subject's body mass index (bmi) and waist circumference at each visit. finally, serum levels of reproductive hormones will be taken. measures of interest will be the percentage of women in each group with absolute and relative cognitive deficits, change over time in performance on neuropsychological tests and scores on depression and anxiety scales, and correlations between cognitive function, mood and hormone level.

Eligibility criteria:
inclusion criteria: menopausal status will be based on self-report of menstrual cycles over the past 12 months. early perimenopause is defined as the presence of irregular periods (cycle length differs by 7 days from usual). late perimenopause is defined as at least 2 skipped periods over the past 12 months (cycle double usual length) and one period of amenorrhea (over 60 days without a period), with at least one menstrual cycle over the past 12 months, according to the stages of reproductive aging workshop criteria. exclusion criteria: - history of neurological disease known to affect cognitive function (i.e., stroke, ms, etc) and major psychiatric illness. the investigators will exclude women who are currently pregnant or breast-feeding, have undergone surgical menopause, or who have used exogenous hormone preparations affecting ovarian or pituitary function in the past 3 months. the investigators will also exclude women who have had hysterectomies, but intact ovaries, or oophorectomies. women who choose to initiate hrt at some point during the study will continue to be followed, but their data obtained after hrt is initiated will be analyzed separately.
addressing patients' expectations of total hip arthroplasty in a randomized trial

Conditions: Hip Osteoarthritis; Arthroplasty, Replacement, Hip

Summary: the goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty.

the first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty. the intervention will be structured according to the expectations listed in the hospital for special surgery total hip replacement expectations survey. the second goal is to test the intervention in a randomized trial. an additional goal is to compare patients' self-reported hip symptoms with radiographic findings.

Eligibility criteria:
inclusion criteria: * patients will be eligible for this study if they are 55 years of age or older and are scheduled for primary total hip arthroplasty at the hospital for special surgery. exclusion criteria: * patients will be excluded from this study for the following reasons: if they are not fluent in english; if they are not going to attend the preoperative hip replacement class; if they are unable to complete the surveys; if they refuse to participate.

Keywords: hip arthritis total hip arthroplasty expectations education
a long-term follow-up study of haemophilia b patients who have undergone gene therapy

Conditions: Hemophilia B

Summary: severe haemophilia b (hb) is a bleeding disorder where a protein made by the body to help make blood clot is either partly or completely missing. this protein is called a clotting factor; with severe hb, levels of clotting factor ix (nine; fix) are very low and affected individuals can suffer life threatening bleeding episodes. hb mainly affects boys and men (approximately one in every 30,000 males). current treatment for hb involves intravenous infusions of fix as regular treatment (prophylaxis) or 'on demand' treatment. on demand treatment is highly effective at stopping bleeding but cannot fully reverse long-term damage that follows after a bleed. regular treatment can prevent bleeding; however it is invasive for patients and also expensive. this clinical study aims to investigate the long-term safety and durability of fix activity in participants who have been dosed with a new gene therapy product (flt180a) in earlier clinical studies. following administration, flt180a results in production of fix in the participants' liver cells which is then released into the blood stream. the aim is to have the participants' own body produce levels of fix that allow for clotting to occur as normal as would be seen in a non-hb individual. this would remove the need for prophylaxis or on demand treatment following just a single administration of flt180a. up to 50 participants who have already been administered with flt180a in the eu and us will take part in this study. participants will be followed up in this trial until they have reached 15 years after being dosed. participants will undergo procedures including physical examinations, join assessments, blood tests and liver ultrasounds. participants will also need to complete a diary to document occurrence of bleeding episodes and record the amount of factor ix concentrate they receive. patient reports outcomes including measures of quality of life, disability and physical activity will also be collected.


Eligibility criteria:
inclusion criteria: * patients who have previously received flt180a within a clinical study. * able to give full informed consent and able to comply with all requirements of the study including long-term follow-up for the time frame the study requires. * willing to practice barrier contraception until at least three consecutive semen samples after vector administration are negative for vector sequences. exclusion criteria: n/a
pt003 mdi cardiovascular safety study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study is primarily a safety study. the primary and secondary endpoints are based on 24-hour holter monitor assessments obtained on day 14 relative to baseline.


Eligibility criteria:
key inclusion criteria: * signed written informed consent * 40 - 80 years of age * clinical history of copd with airflow limitation that is not fully reversible * females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post- bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post- bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * able to change copd treatment as required by protocol * acceptable baseline (visit 2) holter monitor recording key exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray (or ct scan) not due to the presence of copd * hospitalized due to poorly controlled copd within 3 months of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * cancer that has not been in complete remission for at least 5 years * treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives * clinically significant abnormal findings during the baseline holter recording * patients with a pacemaker or icd/crt/crt_d devices other inclusion/exclusion criteria as defined by the protocol

Keywords: copd