Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of next science gel on toenail fungus

Conditions: Onychomycosis of Toenail

Summary: this is a 52 week, 20-patient open-label pilot study on the safety and efficacy of next science wound gel in the treatment of mild to moderate distal subungual onychomycosis.

patients will apply next science wound gel daily to each study treatment hallux nail for 48 weeks once approved for participation. analysis will be attained via potassium hydroxide examination (koh test), nail culture, pcr analysis, and photographic imaging. subjects may have both hallux nails sampled at screening for culture and koh testing if both hallux nails appear to meet the criteria for study inclusion. only subjects with both a positive culture and koh examination will start study treatment. subjects may have repeat koh and culture testing both performed if the first screening test results in at least one of the tests being negative. at investigator's discretion, other affected toenails besides the study target hallux nail may be treated but will not be included for analysis. patients will come for in-clinic visits at screening, baseline/randomization visit/week 0, week 4, week 8, week 12, week 24, week 36, week 48, and week 52. if subjects achieve complete cure (as defined by mycological cure and 0% nail involvement) prior to week 48, patients will be encouraged to continue in the trial with active treatment for the full protocol.

Eligibility criteria:
inclusion criteria: 1. ages 18 years old and above 2. established and active diagnosis of distal subungual onychomycosis of at least one hallux nail affecting 20-75% of the hallux nail 3. positive culture for dermatophytes and positive potassium hydroxide examination 4. provide signed and dated informed consent 5. willing to comply with all study procedures and available for the duration of the study exclusion criteria: 1. known allergic reaction to the study products 2. unable to provide signed and dated informed consent form 3. unable or unwilling to comply with all study procedures and/or unavailable for duration of the study 4. thickness of mycotic nail is greater than 3mm 5. less than 2mm of clear nail at the proximal aspect 6. history of rheumatoid arthritis 7. subject with any other disease or condition other than dso that would affect nail appearance or interfere with image analysis 8. unwilling or unable to limit use of nail polish for duration of study 9. known history of pvd, immune system concerns, or ongoing chemotherapy 10. severe moccasin tinea pedis 11. prior systemic antifungal drugs 6 months before study start date 12. prior topical therapy for toenail fungus 2 months before study start date 13. any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator

Keywords: dso toenail onychomycosis
paula method compared to pelvic floor muscle training (pfmt), for urinary stress incontinence

Conditions: Stress Urinary Incontinence; Sexual Satisfaction; Quality of Life

Summary: the investigators decided to examine whether the paula method is more effective than pelvic floor muscle training (pfmt) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. in addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. these results may indicate that menopausal women with stress urinary incontinence may be more successful controlling incontinence if they will practice the paula method as compared to pfmt.


Eligibility criteria:
inclusion criteria: * women after menopause (12 months with no period) * aged 40 or more * have a positive pad test leakage of 1-50 grams * no systemic or local hormonal therapy * literate in hebrew and/or english exclusion criteria: * women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders) * pelvic surgery within the last 6 months * post hysterectomy or oophorectomy genital prolapse grade 3 or higher
design and methods of the mood disorder cohort research consortium (mdcrc) study

Conditions: Mood Disorders; Bipolar Disorder; Major Depressive Disorder

Summary: the mood disorder cohort research consortium (mdcrc) study is designed as a naturalistic observational prospective cohort study for early-onset mood disorders (major depressive disorders, bipolar disorders type 1 and 2) in south korea.

the mood disorder cohort research consortium (mdcrc) study is designed as a naturalistic observational prospective cohort study for early-onset mood disorders (major depressive disorders, bipolar disorders type 1 and 2) in south korea. the study subjects consist of two populations: 1) patients with mood disorders under 25 years old and 2) patients with mood disorders within 2 years of treatment under 35 years old. after successful screening, the subjects are evaluated using baseline assessments and serial follow-up assessments at 3-month intervals. between the follow-up assessments, subjects are dictated to check their own daily mood status before bedtime using the emood chart application or a paper mood diary. in addition, wearable activity tracker(fitbit charge series) is applied for data collection such as activity, sleep, and heart rate during every moments. at the regular visits every 3 months, inter-visit assessments are evaluated based on daily mood charts and interviews with patients. in addition to the daily mood chart, sleep quality, inter-visit major and minor mood episodes, stressful life events, and medical usage pattern with medical expenses are also assessed. genomic dna from blood is obtained for genomic analyses. from the mdcrc study, the clinical course, prognosis, and related factors of early-onset mood disorders can be clarified. the mdcrc is also able to facilitate translational research for mood disorders and provide a resource for the convergence study of mood disorders.

Eligibility criteria:
inclusion criteria: 1. under 25 years old with mood disorder 2. under 35 years old with mood disorder within 2 years of treatment exclusion criteria: 1. patients with intellectual disability 2. patients with organic brain injury 3. patients have difficulty reading and understanding the korean language

Keywords: cohort study early-onset mood disorders
use of self-collected vaginal swabs as an innovative approach to facilitate testing for repeat chlamydia infection

Conditions: Chlamydia Infections

Summary: the purpose of this study is to determine if, among women who were treated for a prior chlamydial infection, home-based, self-collected vaginal swabs can increase rescreening for chlamydia in comparison with rescreening in the clinic. the study design is two randomized trials with enrollment at multiple family planning clinics and sexually transmitted disease (std) clinics following a common protocol.

the study consists of two complementary trials, denoted as part a and part b. in part a, women/girls who had a positive test for chlamydia will be enrolled when they visit the study clinics for treatment. after written informed consent is obtained, women will be randomly assigned to the clinic group, in which they will be advised to return to the clinic for rescreening for chlamydia, or the home group, in which women will be asked to collect a vaginal swab at home and mail it to the study laboratory for chlamydia testing. in part b, women who were tested and empirically treated for a chlamydial infection will be called if their tests were positive. enrollment will be offered over the phone after verbal consent. rescreening will be scheduled 3 months after treatment of the initial infection for women in both trials.

Eligibility criteria:
inclusion criteria: * women/girls with a lab-confirmed genital chlamydia infection exclusion criteria: * women who are pregnant, or are trying to conceive in the following 3 months. * women who are planning to move in the following 3 months or currently living outside the study areas. * inability to understand spoken english adequately to assure informed consent and compliance with study procedures. * self-reported hiv infection; other serious illnesses or disability. * self-reported allergy to macrolide antibiotics such as azithromycin. * referrals from providers or clinics other than the std or family planning clinics, unless women are re-tested at the std clinics and test positive for chlamydia.

Keywords: chlamydia screening sexually transmitted disease
study to assess the effect of bms-790052 on the pharmacokinetics of ortho tri-cyclen® in healthy female subjects

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to assess the effect of bms-790052 on the pharmacokinetics of ortho tri-cyclen® in healthy female subjects.


Eligibility criteria:
key inclusion criteria: * healthy female subjects, 18-45 years, bmi 18-32 kg/m². * must be using an adequate method of contraception to avoid pregnancy throughout the study. key exclusion criteria: * abnormal pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3 months prior to enrollment. * any significant or chronic uncontrolled medical illness.
improvement of hand dysfunction by arthritis in systemic sclerosis

Conditions: Systemic Sclerosis; Arthritis

Summary: systemic sclerosis (ssc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. for the assessment of arthritis, the cdai (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for ssc-related arthritis, too. this observational trial is part of the collaborative project "desscipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. aim of this observational trial is to: * investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and * to validate the cdai for arthritis in systemic sclerosis.


Eligibility criteria:
inclusion criteria: * juvenile and adult systemic sclerosis patients, with diagnosis according to the acr/eular adult ssc criteria and pres/acr/eular juvenile ssc criteria respectively * clinical signs of arthritis (defined as ≥2 tender and swollen joints) exclusion criteria: * presence of significant, long standing articular pain due to other cause than autoimmune disease * presence of hand disability caused by other, than autoimmune disease
substitution of the pcl in tka with uc or ps design

Conditions: Patient Reported Outcome; Knee Osteoarthritis; Knee Arthroplasty

Summary: rct comparing uc and ps tka

rct comparing tka with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament

Eligibility criteria:
inclusion criteria: * scheduled for tka exclusion criteria: * higher constraint needed
cross therapy registry - oedema - eu (ctr-oedema-eu)

Conditions: Edema Leg

Summary: the geko™ cross therapy registry - oedema - eu (gekotm ctr - oedema- eu) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months.

the geko™ device has a wide range of clinical applications including the post- operative management of oedema. although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during follow-up of up to twelve months. as the manufacturer of the device, firstkind limited has an obligation to collect safety and performance data to comply with current regulations (mdr eu 2017/745 annex xiv, part b). consequently, there is a need for an observational study to provide data to demonstrate patient benefit and regulatory compliance. the geko™ cross therapy registry - oedema -eu (gekotm ctr - oedema - eu) study will prospectively and systematically collect clinical data on all device variants used in standard care pathways for edema management allowing for the monitoring of patient outcomes during a follow-up period of up to twelve months. this study forms part of the overall post-market clinical follow-up strategy for the device and post market surveillance (pms) to support device and performance.

Eligibility criteria:
inclusion criteria: * 18 years and able to provide written informed consent. * intact healthy skin at the site of gekotm device application. * subjects receiving gekotm therapy as part of their standard care for oedema reduction. exclusion criteria: * pregnancy or breast feeding. * use of any concurrent neuro-modulation device. * trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve. * no involuntary movement of the lower leg/foot at the maximum tolerable device setting.

Keywords: edema leg
safety, long term immunogenicity and lot consistency study of liquid pentavalent combination vaccine

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Influenzae Type B

Summary: a randomized phase iv study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.


Eligibility criteria:
inclusion criteria: * healthy children in the age group six to eight weeks * born after a normal gestational period (36 - 42 weeks) * mother's hbsag (hepatitis b surface antigen) assured negative. * father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form. exclusion criteria: * administration of immunoglobulin or any blood products since birth. * use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination opv \& bcg vaccine) during the study period or within 30 days preceding the first dose of the study vaccine. * previous vaccination or evidence of infection with dtp or hib. * history of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics. * major congenital or hereditary immunodeficiency. * infants born to mothers known to be hiv positive. * infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a cns disorder at the time of vaccination. * infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40c, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction. * parent/s or guardian of subject unable to maintain diary card

Keywords: vaccine prevention diphtheria tetanus pertussis hepatitis b haemophilus influenzae type b lot consistency long term immunogenicity reactogenicity healthy infants
kios mobile app evaluation

Conditions: Opioid Use Disorder

Summary: evaluation of a mobile medical app (kios) vs. treatment as usual for the treatment of opioid use disorder (oud).

the study is a parallel intervention examining the kios app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. kios will offer individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. kios makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. kios gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.

Eligibility criteria:
inclusion criteria: 1. male or female outpatients 18 years of age or older 2. patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. 3. dsm-5 (diagnostic and statistical manual of mental disorders fifth edition) criteria for opioid use disorder 4. ability to access kios via smartphone or tablet 5. recently (less than 6 months) enrolled in and currently participating in moud at a clinic in texas exclusion criteria: 1. unwilling or unable to comply with study requirements 2. psychiatric or medical disorder interfering with ability to use the app 3. incarceration

Keywords: digital health therapeutic behavioral intervention strategies clinic-based counseling
impact of aromatase inhibitor therapy on glucose homeostasis and diabetes risk

Conditions: HER2-Positive Breast Carcinoma

Summary: this study assesses the effect of hormone directed treatment for breast cancer on glucose metabolism.

primary objective: i. assess the impact of endocrine adjuvant therapy with aromatase inhibitors in women with hormone receptor positive breast cancer, on various indices of glucose homeostasis, utilizing oral minimal model assessment, in comparison to healthy post menopausal women and another cohort of women on tamoxifen. outline: this is an observational study. patients undergo blood sample collection, glucose testing, dexa scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * post-menopausal women with hormone receptor positive breast cancer. post-menopause will be defined as women who experience 12 months of amenorrhea or have undergone bilateral salpingo-oophorectomy. * 25 women who are planning to start or are within 6 months of starting treatment with aromatase inhibitors, after consultation in breast clinic and cancer center. * 25 women who will be starting tamoxifen (comparative group) * 25 healthy post menopausal women will also be recruited. exclusion criteria: * established diagnosis of diabetes * therapy with medications that could affect glucose metabolism * screening fasting glucose ≥ 126 mg/dl, and/or hba1c ≥ 6.5% * history of upper gi surgery that alters gastric emptying or causing malabsorption e.g., bariatric surgery, fundoplication
metabolome and microbiome impact on acute gvhd in recipients of hematopoietic transplant

Conditions: Graft-versus-host Disease

Summary: recent published data suggest that specific alterations in intestinal metabolome signature of hematopoietic stem cell transplant (allo-sct) recipients might influence incidence and severity of acute graft versus host disease (agvhd). nevertheless, this possible relationship has not been undoubtedly established, pathophysiologic mechanisms have not been elucidated and possible clinical implications have not been studied. we hypothesized that in the early phase of allo-sct, specific alterations in faecal metabolome occurred related to loss of intestinal microbiota diversity and disbalance of specific bacterial taxa, and that both alterations determine reduced survival of patients through increased incidence and severity of agvhd. to test this hypothesis, a prospective multi-center cohort of allo-sct recipients will had faecal and plasmatic samples collected at predetermined time-points pre\&post-allo-sct, and clinical relevant variables will be prospectively recorded throughout two years posttransplant follow-up. metabolomic and microbiome analysis will be done to answer objectives of the study. to additionally explore if differential evolving characteristics in the intestinal metabolome and microbiome of donor/recipient sibling pairs influence the incidence and severity of agvhd, probability of malignancy relapse and early and late mortality an additional cohort of family donors of enrolled patients will also have faecal and plasmatic samples collected and analysed.


Eligibility criteria:
patients patients receiving an allotransplant at participating hospitals during the study period before initiating conditioning period. inclusion criteria: * patients of any age who will receive allogeneic hematopoietic transplantation of any modality with any diagnosis. * agreement of the patient to participate by signing the informed consent or his/her legal representatives/assent (if applicable). exclusion criteria - allotransplant recipients in stages after the initial pre-conditioning. donors family donors from patients included in the study: inclusion criteria: * agreement of the donor to participate by signing the informed consent or his/her legal representatives/assent (if applicable). * donor relatives with any degree of identity in the human leukocyte antigens (hla). exclusion criteria: * unrelated donors * transplants from umbilical cord blood source.

Keywords: acute graft-versus-host disease microbiome metabolome hematopoietic transplant
measurement of the biting force of rabid heat cured acrylic resin versus modified conventional acrylic

Conditions: Dental Anxiety

Summary: the purpose of this study is to compare the effect of rapid heat cured acrylic resin material with titanium dioxide nanoparticles added to conventional acrylic resin material on the biting force of the single maxillary complete denture .

bite force is one indicator of the functional state of the masticatory system that results from the action of jaw elevator muscles modified by the craniomandibular biomechanics .determination of individual bite force level has been widely used in dentistry, mainly to understand the mechanics of mastication for evaluation of the therapeutic effects of prosthetic devices and to provide reference values for studies on the biomechanics of prosthetic devices. in addition, bite force has been considered important in the diagnosis of the disturbances of the stomatognathic system . twenty (20) single maxillary completely edentulous patients were selected from the out-patient clinic of the removable prosthodontics department, faculty of oral and dental medicine, cairo university. the primary outcome is to measure the biting force of single maxillary complete denture by i load star sensor .

Eligibility criteria:
inclusion criteria: * completely edentulous maxillary arch and full or partial dentate mandibular arch with adequate inter arch space * edentuluos arches should be covered by firm healthy mucosa angle class 1 maxillomandibular relationship exclusion criteria: * patients with bad habits * previous history of radiotherapy or chemotherapy