Kornimate/medical-research-clean huggingface dataset:
evaluation of quality of life (qol) in subjects with highly active relapsing multiple sclerosis (ms) (clarify ms)

Conditions: Multiple Sclerosis

Summary: the main purpose of the study was to assess the health-related quality of life (hrqol) through the multiple sclerosis quality of life-54 questionnaire (msqol-54) scale in highly-active relapsing multiple sclerosis (rms) particpants treated with mavenclad® for 2 years (24 months).


Eligibility criteria:
inclusion criteria: * highly active rms as defined by: * one relapse in the previous year and at least 1 t1 gadolinium (gd)+ lesion or 9 or more t2 lesions, while on therapy with other disease modifying drugs (dmds). * two or more relapses in the previous year, whether on dmd treatment or not. * expanded disability status scale (edss) score less than equals to (\<=) 5.0. * other protocol defined inclusion criteria could apply. exclusion criteria: * positive hepatitis c or hepatitis b surface antigen test and/or core antibody test for immunoglobulin g (igg) and/or immunoglobulin m (igm). * current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (hiv) result. * currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids. * history of tuberculosis, presence of active tuberculosis, or latent tuberculosis * presence of progressive multifocal leukoencephalopathy (pml) in magnetic resonance imaging (mri). * active malignancy. * other protocol defined exclusion criteria could apply.

Keywords: multiple sclerosis mavenclad® cladribine health-related quality of life
biobank on prematurity, preeclampsia and other pregnancy complications

Conditions: Preeclampsia; Preterm Birth; Pregnancy Complications; Fetal Anomalies

Summary: the biobank includes data and biological specimens of women from three original studies: 1) first-trimester prediction of preeclampsia (prediction study, nct02189148), 2) pre-eclampsia and growth retardation, an evaluative longitudinal study (pearl study, nct02379832), 3) effect of low dose aspirin on birthweight in twins: the gap trial (nct02280031) and 4)prediction2: prediction of preeclampsia and other pregnancy complications following combined iterative screening.

this biobank is comprised of: 1) medical, social, obstetrical and ultrasonographic data, 2) human biological samples (maternal plasma, serum and buffy coat, maternal urine, cord blood) and 3) the results derived from these (biochemical or ultrasonographic markers, genetics, risk calculations ...)

Eligibility criteria:
inclusion criteria: * (specific to each study) exclusion criteria: * pregnant women \<18 years old at recruitment * negative fetal heart at recruitment * women not able to provide an informed consent to the study
improving transportation assets and the effects on wellness metrics

Conditions: Social Determinants of Health

Summary: 1. implementation of an advanced connected transportation network (actin), a novel, collaborative multinetwork transportation model for small cities and rural areas. 2. evaluation of effectiveness in improving transportation assets for clients of a community-based nonprofit specializing in addressing social determinants of health (lighthouse community health services in lynchburg, va). 3. simultaneous evaluation of wellness metrics based on the standards of the cms annual wellness visit and metrics associated with common chronic diseases.

1. implementation of a community transportation solution the project will be managed by unified potential, inc., a 501c3 tax-exempt organization for transportation. * the solution requires implementation of four separate transportation "networks" * public / contracted / for-hire transportation * workforce transportation network * community rideshare network * volunteer transportation network 2. assessment of personal transportation assets * subjects asked to complete a survey upon intake, at six months, and at one year * digital survey: * can be completed by individual using provided smartphone app or at onsite desktop kiosk * can be facilitated by a caregiver or other provider not involved in data analysis 3. assessment of health and wellness metrics and chronic disease metrics if applicable * dataset based on metrics assessed in the center for medicare and medicaid services (cms) annual wellness visit * all metrics quantified via either binary (yes/no) or through use of a validated scale (see below) * data collected electronically at onsite or in-home provider visits at intake, six months, and one year

Eligibility criteria:
inclusion criteria: * adult resident of the city of lynchburg, virginia * under-resourced at trial entry as defined by meeting eligibility for welfare, food stamps/snap, medicaid, housing choice voucher program, or income at or below 200% of the federal poverty threshold. exclusion criteria: * none
tms treatment in parkinson's disease with pain.

Conditions: Transcranial Magnetic Stimulation; Parkinson Disease; Pain

Summary: transcranial magnetic stimulation (tms) is a procedure that has been shown to improve pain in chronic sufferers. it is a well-tolerated procedure that can be performed on an outpatient basis. it uses a plastic covered coil that sends a magnetic pulse through the skull into the brain and by targeting particular areas in the brain it can be used to help modulate the perception of pain. the study intends to use this technique to treat such a disabling symptom in patients who suffer from parkinson's disease (pd). initially the aim is to study this technique in 48 patients who are suffering from pain and have pd. these patients would require an eeg before and after the stimulation. the stimulation would be performed over ten sessions and the patients would be assessed by a clinician using well recognized clinical tools. it is anticipated that there will be a meaningful improvement in pain. it is also anticipated that tms is a safe technique to use in patients with pd. the study will be used to help plan a future study that compares tms with sham technique to prove whether tms could be an option in the treatment of such a disabling condition.


Eligibility criteria:
inclusion criteria: 1. patients with parkinson's disease diagnosed as "clinically confirmed" or "very likely" according to the 2015 mds clinical diagnostic criteria; 2. age ≥ 18 aged ≤ 80 years old; 3. pd patients with pain, exclude tumors, diabetes, osteoarthritis, rheumatoid rheumatism and other diseases, the use of analgesic drugs is not effective or insignificant. 4. after treatment with anti-parkinson's disease drug regimen, anti-anxiety and depression, sleep drugs, analgesic drugs, etc. for ≥ 14 days, and the dosage is maintained during the treatment; 5. ability to follow research plans and visit plans. exclusion criteria: 1. secondary parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or parkinson's superposition syndrome. 2. pd patients with persistent head tremors. 3. dementia, simple intelligent state check (mmse) ≤ 24 points. 4. patients with suicidal tendencies and psychotic symptoms. 5, previously accepted dbs or damage surgery. 6. contraindications for tms (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)

Keywords: tms parkinson's disease pain
repeat doses of sb-728mr-t after cyclophosphamide conditioning in hiv-infected subjects on haart

Conditions: Human Immunodeficiency Virus (HIV)

Summary: the purpose of this study is to evaluate the safety and tolerability of repeat doses of t-cell immunotherapy (sb-728mr-t) following cyclophosphamide conditioning. ccr5 is a major co-receptor for hiv entry into t-cells. disruption of ccr5 by zinc finger nuclease (sb-728mr), blocks hiv entry into the t-cells, therefore, protects the t-cells from hiv infection. safety (primary outcome) and anti-viral effect (secondary outcome) of zinc finger nuclease-mediated ccr5 disrupted autologous t-cells (sb-728mr-t) will be evaluated in the study.


Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older with documented hiv diagnosis. * must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption. * initiated haart therapy within (≤) 1 year of hiv diagnosis or suspected infection. * undetectable hiv-1 rna for at least 2 months prior to screening and at screening. * cd4+ t-cell count ≥500 cells/µl. * absolute neutrophil count (anc) ≥ 2500/mm3. * platelet count ≥ 200,000/mm3. exclusion criteria: * acute or chronic hepatitis b or hepatitis c infection. * active or recent (in prior 6 months) aids defining complication. * any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia. * current diagnosis of nyha grade 3 or 4 chf, uncontrolled angina or uncontrolled arrhythmias. * history or any features on physical examination indicative of a bleeding diathesis. * received hiv experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector. * use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening. * use of aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis. * currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit. * currently taking maraviroc or have received maraviroc within 6 months prior to screening.
systematic pain assessment in nursing home residents with advanced dementia

Conditions: Pain; Dementia; Quality of Life

Summary: it is estimated that 45-80 % of nursing home residents have substantial pain at any given time. residents with impaired cognition have been found to report chronic pain more often, more frequent and more severe, compared to residents with normal cognition. approximately 3/4 of permanent residents in nursing homes in norway have developed dementia. the burden of dementia is often compounded by painful conditions. despite over a decade of research on the subject, inadequate pain assessment and management remain significant problems among institutionalized older adults, with and without dementia. the poor pain management in patients with dementia has been attributed, at least in part, to difficulties with, and lack of, pain assessment in this population. therefore, this study seek to determine the effect of regular pain assessment.

the aim of the study is to determine the effect of regular pain assessment on pain management interventions applied and patient outcomes among patient with severe dementia. a cluster randomized controlled trial will be conducted. a cluster is defined as a single independent nursing home. the clusters will be randomly assigned to either the experimental or control condition. appropriate information will be given to both the intervention and the control group. all nurses in the experimental conditions will be taught how to administer the doloplus-2. the study will start after the initial education session. during the 3-month study period, the participating nursing staff will be asked to complete the doloplus-2 regularly. the control groups will receive standard methods of care. data collection at baseline and at 4, 8 and 12 months.

Eligibility criteria:
inclusion criteria: * ≥ 65 years old * dementia diagnosis * severe language impairment/non-communicative * clinically significant pain and/or behavioral symptoms: a score of at least 44 on the norwegian version of the cohen-mansfield agitation inventory (cmai), * or a score of at least 4 (frequency × severity) on items of the neuropsychiatric inventory - nursing home version (npi-nh), * or an indication of clinically significant pain (≥ 5) according to the doloplus-2 at baseline exclusion criteria: * short term stay, \< 4 weeks * primary psychiatric diagnosis * delirium
comparison between two different high power ablative lasers in the treatment of oral leukoplakia

Conditions: Leukoplakic Lesions

Summary: oral leukoplakia is a precancerous lesion with relatively high malignant transformation potential. they are often treated by wide surgical excisions or conservative retinoids therapy. the use of high power ablative lasers has been proposed as an effective way of treating these lesions safely. the aim of this study was to evaluate efficiency er:yag and er,cr:ysgg laser, in the treatment of oral leukoplakia.

the purpose of this research was to determine the effectiveness of two high-power ablative lasers in the treatment of oral leukoplakia. furthermore, the purpose was to compare reciprocally and evaluate the subjective and objective postoperative parameters for two different tested ablative lasers, er: yag and er, cr: ysgg. all the patients were referred to the department of oral medicine or oral surgery where a biopsy and measuring the size of lesion that meet the criteria of the histopathological diagnosis of leukoplakia was performed. patients who met the conditions of pathohistological diagnosis of leukoplakia and clinical criteria for diagnosis of non-homogeneous leukoplakia, were included in the research. the patients were randomly allocated into one of the two test groups. in the first group of patients leukoplakia lesion were removed using high-power ablative laser er: yag and to those in the second group using high power ablative er, cr: ysgg laser. the patients were monitored one year and six months after treatment to evaluate subjective and objective parameters focused on life quality after treatment and in case of eventual relapse. criteria of effectiveness for lasers were appearance of relaps in one year and six months following.

Eligibility criteria:
inclusion criteria: * based clinically diagnosed non homogeneous leukoplakia exclusion criteria: * immunocompromised patients * hiv positive patients * patients on suppressive therapy

Keywords: laser therapy recurrence leukoplakia precancerous lesion
depression and fatigue in ms patients treated with betaferon.

Conditions: Multiple Sclerosis

Summary: this study aims to evaluate the occurence and severity of fatigue and depression in multiple sclerosis patients and the impact of betaferon treatment on symptoms alterations. the study is conducted in routine practice setting hence no interference with standard care takes place. pharmacologic treatments of ms-fatigue and depression will also be recorded.


Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple sclerosis * age 18+ * patients initiating betaferon treatment exclusion criteria: * patients previously treated with any immunomodulatory drug

Keywords: multiple sclerosis interferon beta-1b fatigue depression
treatment of chidamide and venetoclax for retinoic acid and arsenic resistant acute promyelocytic leukemia

Conditions: APL

Summary: based on the current treatment with retinoic acid (atra) and arsenic (as), most patients with apl achieved long-term survival. there are few patients relapsed and became refractory to the ra and as treatment. in our pre-clinical study, we found that targeting histone deacetylase inhibitor 3 (hdac3)degraded pml-rara oncoprotein and induced differentiation and apoptosis of ra and as resistant apl in vitro and in vivo. in this study, we evaluate the efficacy and feasibility of combination therapy for hdac3 inhibitor and venetoclax in patients with refractory apl.

for patients with newly-diagnosed acute promyelocytic leukemia (apl), the combination therapy retinoic acid (atra) combined with arsenic (as) is the mainstay upfront treatment. most patients enjoy long-term survival with or without chemotherapy. even though with such good prognosis, there are still some patients relapsed and eventually became refractory to ra and as treatment. in our pre-clinical study, we demonstrate that targeting histone deacetylase inhibitor 3 (hdac3) could degrade pml-rara oncoprotein and induce differentiation and apoptosis of ra and as resistant apl in vitro and in vivo. in this multi-center prospective study, we evaluate the efficacy and feasibility of combination therapy for hdac3 inhibitor (chidamide) and venetoclax in patients with refractory apl.

Eligibility criteria:
inclusion criteria: * patients with pml-rarα+ apl * patients in non-remission status after treatment of ra combined with as * patients with life expectance \>=3 months * inform consent provided exclusion criteria: * patients with incontrollable infection * patients with life-expectancy less than 2 months * patients with abnormal liver (\>3xn) and renal function (\>3xn）

Keywords: refractory，apl
intrathecal prilocaine and adductor canal block vs intrathecal bupivacaine alone for ambulatory knee arthroscopy

Conditions: Post Operative Pain

Summary: - although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) score i-ii. * body mass index \< 35 kg/m2 exclusion criteria: * patient's refusal. * known coagulopathy. * known peripheral neuropathy or neurological deficits. * known allergy to study drugs.
a study to evaluate the effectiveness and safety of rxi 109 on the outcome of revised hypertrophic scars

Conditions: Hypertrophic Scar

Summary: the purpose of this study is to determine the effectiveness of rxi-109 in reducing the recurrence of hypertrophic scar formation following elective revision of a pre-existing hypertrophic scar.


Eligibility criteria:
inclusion criteria: * adults, 21-55 years of age * general good health * previous surgery or injury resulting in a hypertrophic scar exclusion criteria: * scars on the face or front of neck may not be included in the trial * use of tobacco or nicotine-containing products * pregnant or lactating

Keywords: hypertrophic scar cicatrix scar prevention scar revision
effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of indonesian men

Conditions: Androgenetic Alopecia

Summary: the goal of this clinical trial is to compare the effectiveness of combination therapy of microneedling and minoxidil in androgenetic alopecia of indonesian men. the main questions it aims to answer are: * is there an increase in hair density with combination therapy of microneedling and minoxidil versus minoxidil monotherapy? * is there an increase in hair diameter with combination therapy of microneedling and minoxidil versus minoxidil monotherapy? participants will be divided into 2 groups. the first one will receive minoxidil monotherapy, and the second one will receive a combination therapy of microneedling and minoxidil. researchers will compare those 2 groups to see if there is a difference of effectiveness based on hair density and diameter.


Eligibility criteria:
inclusion criteria: * male * indonesian * age 18-59 years * diagnosis of androgenetic alopecia * hamilton-norwood type iii-iv exclusion criteria: * use of minoxidil or finasteride topical 1 month prior * use of minoxidil or finasteride oral 1 month prior * skin infection in the treatment area * cosmetic procedures for the treatment of alopecia androgenetic such as platelet rich plasma, laser therapy,or microneedling 3 months prior * history of keloid
objective confirmation of thе anti-ischemic effectiveness of trimetazidine 80mg once daily in patients with stable angina who had a history of myocardial infarction (method)

Conditions: Coronary Artery Disease

Summary: method is a prospective observational program that will be conducted in 1centre of the russian federation. prospective follow-up will be for about 6 months. the method study is a 2 visit study with first visit of inclusion and second visit of completion of the study. patients with stable angina pectoris eligible to the study inclusion criteria will be invited to participate in this observational program. the parameters for analysis will be collected by doctors and entered into crf. the final analysis will include data from patients who were taking tmz 80 mg od during the observational period. the decision to stop the study will be made once 36 patients receiving treatment with trimetazidine 80 mg od will have been evaluated at v1. it is expected that 5 cardiologists will participate in the program. the planned number of patients is 36.

to describe antiischemic and antianginal effectiveness of trimetazidine od 80 mg as well as adherence to the treatment with tmz 80 mg od in patients with stable angina pectoris and prior mi in real clinical practice in russia

Eligibility criteria:
inclusion criteria: * age older than 18 yearsage older than 18 years * signed informed consent form * stable angina pectoris (ccs i-iii fc) with signs of myocardial ischemia despite treatment with antianginal drug(s) present either clinically and/ or at stress echo test with dobutamine * history of myocardial infraction occurred 6 months and more from the inclusion date * trimetazidine (tmz) is recommended as add on to the current antianginal treatment and this recommendation precedes inclusion of a patient in the study * intention to perform a stress echo with spackle tracking precedes the start of tmz * physician's intention to perform a stress echo test within a 6-month period after the date of inclusion in the study exclusion criteria: * age over 75 years or under 18 years old * hypersensitivity to the active substance or any excipient specified in smpc of tmz 80 mg od * parkinson's disease, parkinsonism symptoms, tremors, restless legs syndrome and other accompanying movement disorders * known severe or moderate renal impairment (creatinine clearance \<60 ml / min). * angina pectoris of iv functional ccs class * heart failure iv functional class by nyha * cardiac valves insufficiency with regurgitation of stage iii and higher * myocardial infarction less than 6 months from the inclusion date * acute cerebrovascular event (stroke of various origins, transient ischemic attack) within 6 months before screening date * uncontrolled arterial hypertension of stage 3 (blood pressure above 180/100 mm hg) despite ongoing antihypertensive therapy * fructose / sucrose intolerance, presence of glucose-galactose malabsorption syndrome, sucrose-somaltase deficiency and other enzymopathies associated with intolerance to sucrose, which is part of the drug * pregnancy, breastfeeding * any contraindications to stress echocardiography with dobutamine