Kornimate/medical-research-clean huggingface dataset:
treatment of hypertrophic scars using fractional laser and fractional laser-assisted topical corticosteroid delivery

Conditions: Hypertrophic Scars

Summary: the objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.

hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. however, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation. recent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.

Eligibility criteria:
inclusion criteria: * female subjects with age range 18-60 years; * subject with hypertrophic scar from abdominal surgery for at least 3 months; * discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months exclusion criteria: * subject who has skin infection, photosensitive dermatosis or inflammatory acne on the treated area; * subject who smoke cigarette; * subject who was treated with intralesional corticosteroid

Keywords: fractional laser hypertrophic scar topical corticosteroid laser assisted delivery systems
patient education in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study was carried out to investigate the effect of a nurse-led disease management education program in as on patient compliance, disease activity, functional capacity, kinesiophobia, and quality of life. a total of 122 patients diagnosed with as according to the modified new york criteria were included in the study. the intervention group received nurse-led individualized disease management education. in the control group, no interventions were performed other than routine clinical procedures.

this study was carried out to investigate the effect of a nurse-led disease management education program in as on patient compliance, disease activity, functional capacity, kinesiophobia, and quality of life. a total of 122 patients diagnosed with as according to the modified new york criteria were included in the study. the intervention group received nurse-led individualized disease management education. after the education, the group was contacted by telephone six times for 12 weeks to monitor the results. patient education was provided through booklets and videos. in the control group, no interventions were performed other than routine clinical procedures.patients were assessed using the same scales at baseline and end of the week 12.

Eligibility criteria:
inclusion criteria: * age: 18 years * have a clinical diagnosis as according to the modified new york criteria * receiving tnf-α inhibitor treatment. exclusion criteria: * communication difficulties * illiterates

Keywords: patient education nursing rheumatology
efficacy and safety of a combination of mycophenolate mofetil and corticosteroid in advanced iga nephropathy

Conditions: IgA Nephropathy

Summary: the purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with mycophenolate mofetil in combination with corticosteroid in patients with advanced iga nephropathy. the control group will be observed for up to 48 weeks without administration of mycophenolate mofetil.

the subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated. the study group were taken 48 weeks with myrept ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration maintenance. the subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.

Eligibility criteria:
inclusion criteria 1. patient aged 19 to 65 years old 2. diagnosed with iga nephropathy 3. confirmed with proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening 4. if egfr (by mdrd) is \<50 ml / min / 1.73 m\^2, ≥ 15 ml / min / 1.73 m\^2 5. ace inhibitor or arb for at least 3 months 6. willing and able to provide written informed consent. exclusion criteria: 1. if egfr (by mdrd) is \<15 ml / min / 1.73 m\^2 2. blood pressure is sbp\> 160 mmhg or dbp\> 100 mmhg 3. systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer) 4. serious digestive disorder 5. wbc \<3000 / mm\^3 6. acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of investigational drugs 7. administration of other investigational drugs within 28days before screening period 8. administration of investigator drug or other immunosuppressants within 84days before screening period 9. women in pregnant or breast-feeding or don't using adequate contraception. 10. patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc. 11. in investigator's judgment
ublituximab in combination with lenalidomide in patients with b-cell lymphoid malignancies

Conditions: Non-Hodgkins Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; B-cell Lymphomas; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Waldenstrom's Macroglobulinemia

Summary: the purpose of this study is to determine whether ublituximab in combination with lenalidomide (revlimid®) is safe and effective in patients with b-cell lymphoid malignancies who have relapsed or are refractory after cd20 directed antibody therapy.

the study was intended to be a phase 1/2 study, however, the study was terminated early and the phase 2 portion was never initiated. a limited number of participants were enrolled in phase 1 and no maximum tolerated dose (mtd) or phase 2 dose was identified for the combination of ublituximab and lenalidomide. thus, phase 2 data and results are not available to be reported.

Eligibility criteria:
inclusion criteria: * relapsed or refractory b-cell non-hodgkins lymphoma (nhl), chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) * participants must have received at least one prior line of therapy with an anti-cd20 antibody (i.e. rituximab, ofatumumab, etc.) or an anti-cd20 antibody containing regimen * measurable or evaluable disease * eastern cooperative oncology group performance status 0, 1 or 2 * participants ineligible for high dose or combination chemotherapy + stem cell transplant * no active or chronic infection of hepatitis b or c and no history of hiv based on negative serology * all study participants must be registered into the mandatory revassist® program, and be willing and able to comply with the requirements of revassist® exclusion criteria: * prior chemotherapy, investigational therapy or radiotherapy within 3 weeks of study entry * prior autologous or allogeneic stem cell transplantation within 6 months of study entry * history of severe hypersensitivity or anaphylaxis to prior murine or mouse/human chimeric antibodies, or to any component of ublituximab, or with prior lenalidomide or thalidomide * uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements * history of deep vein thrombosis (dvt) or pulmonary embolus (pe) in the six months prior to day 1 of cycle 1 * pregnant women

Keywords: lymphoma monoclonal antibody immunomodulatory agent ublituximab lenalidomide
platelet rich plasma (prp) as a treatment for knee osteoarthritis prp as a treatment for knee osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: autologous platelet-secreted growth factors (gfs) may have therapeutic effects in osteoarthritis (oa) capsular joints via multiple mechanisms. the aim is to examine the effect of a platelet-derived preparation rich in growth factors (prgfs) in oa of the knee.

autologous platelet-secreted growth factors (gfs) may have therapeutic effects in osteoarthritis (oa) capsular joints via multiple mechanisms. the investigators aim is to examine the effect of a platelet-derived preparation rich in growth factors(prgfs) in oa of the knee, using parameters of pain, function, quality of life and safety.

Eligibility criteria:
inclusion criteria: * age 40-75 years old * diagnosed oa of the knee more then 1 year * no knee deformation exclusion criteria: * mental of physical disabilities * pregnancy * deformities of the knee

Keywords: osteoarthritis prp prgf hyaluronic acid
a placebo-controlled study with an extension examining the safety and efficacy of alefacept in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (mtx) vs. placebo + mtx followed by a 24-week open-label extension with only alefacept + mtx treatment.

patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable mtx dose and also received alefacept throughout this extension.

Eligibility criteria:
inclusion criteria: * psoriatic arthritis * mtx treatment for 3 months prior to enrollment with continuing disease * normal t-cell count exclusion criteria: * other types of psoriasis * history of malignancy or lymphoproliferative disorder * serious infection or fever * antibody positive for hepatitis c, hiv or tb * hepatic transaminases \> 2x normal

Keywords: psoriatic arthritis psoriasis alefacept
use of the bioabsorbable activa im-nail™ in pediatric diaphyseal forearm fractures

Conditions: Fracture Fixation, Intramedullary; Forearm Fracture; Fracture Healing; Child, Only; Implant Complication

Summary: background pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. fractures in need of surgery are often treated with metal elastic stable intramedullary nails (esin). nail removal after 6-12 months is generally advocated. surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. bioabsorbable intramedullary nails (bin) have been developed for the same indications as metal esin. the use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs. methods the investigators aim to recruit all children in the catchment area of herlev and gentofte university hospital (copenhagen, denmark) with acute unstable diaphyseal forearm fractures. participants will be operated with bin and followed consecutively for 2 years with interim analysis of data after 6 months. the investigators will report radiological healing using the radiographic union score (rus) 3 months after surgery together with any adverse events during follow-up. discussion this study will provide important preliminary data and asses the feasibility of using the bioabsorbable activa im-nail™ in pediatric diaphyseal forearm fractures. this study is a pilot study for initiating an rct comparing bin to metal esin hypothesizing that bin is not an inferior treatment.


Eligibility criteria:
inclusion criteria: * acute traumatic diaphyseal forearm fracture of the radius, ulna or both * fractures need to be complete (not unicortical or green stick) * displaced more than 50% of bone width or angulated more than 10° in any plane or irreducible or unstable after reduction exclusion criteria: we exclude patients * with fractures that are well managed conservatively (undisplaced or minimally displaced) * with previous ipsilateral forearm fracture * with fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal) * with fractures with ipsilateral wrist or elbow involvement (e.g. monteggia or galeazzi variants) * unable to participate in follow-up * with existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease) * in whom internal fixation is otherwise contraindicated (e.g. active or potential infection)
de-escalation of empirical antimicrobial therapy study in severe sepsis

Conditions: Severe Sepsis

Summary: rational: severe sepsis is one of the leading cause of mortality in intensive care unit patients. early initiation of an appropriate empirical antimicrobial therapy is associated with improved outcomes. in order to avoid an increase of selection pressure and the emergence of multidrug resistant pathogens, guidelines recommend to streamline the antimicrobial therapy after the identification of the pathogen responsible for infection. this strategy has been evaluated in several observational studies. however, at the bedside, few randomized clinical trials tested this strategy prospectively. method: the investigators conduct a randomized clinical trial comparing a strategy based on de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative strategy (continuation of the empirical antimicrobial therapy). the investigators first aim was to show that a strategy based on de-escalation is not inferior to a conservative strategy in terms of intensive care unit length of stay. secondary aims are to compare the rate of mortality rate, the emergence of multidrug resistant pathogens, and the feasibility of de-escalation. the study is performed in nine intensive care units from four institutions, and 120 patients are required to validate the investigators hypothesis. new technologies for the rapid diagnosis of severe infections are investigated in an ancillary study.


Eligibility criteria:
inclusion criteria: * major subject; * subject having a sepsis engraves(burns) defined according to the following criteria during the initiation of the probability antibiotic treatment: * criteria of sirs \[ 14 \], * and a suspected infection, * and a failure of organ: low blood pressure, respiratory failure, coma, hepatic insufficiency, renal insufficiency, thrombopénia, spontaneous extension of the tca, * subject for which an antibiotic treatment was begun within 6 hours following the diagnosis of sepsis engraves(burns); * subject for which a taking with microbiological aim was made within 48 hours following the diagnosis of sepsis exclusion criteria: * minor subject, pregnant or breast-feeding woman; * neutropénia (pn \< 1000 / mm3); * absence of identification of a microorganism in the microbiological examinations; * absence of social security; * subject deprived of freedom or under guardianship; * subject for which the lit(enlightened) consent is not collected(taken in) (itself and/or reliable person).
dietary treatment strategies and metabolic control in glycogen storage disease type i

Conditions: Glycogen Storage Disease Type I

Summary: the present project will specifically assess metabolic effects of dietary interventions with controlled intake of fructose and fructose/galactose in gsdi, with the aim to provide evidence whether relaxed dietary restrictions of fructose and galactose may be justified in treatment recommendations at least for adults, which would considerably enlarge food choice in everyday life of the patients with an expected positive impact on the quality of life of patients with this rare disorder.

to assess relaxed restriction of fructose and fructose/galactose intake on secondary metabolic alterations in gsdi, (i) by looking at the traditional parameters for assessing metabolic control in clinical chemistry (lactate, triglycerides, uric acid), and (ii) by using a broad analytical approach relying on targeted metabolomics/lipidomics. it is hypothesized that relaxed restrictions on the intake of fructose and/or galactose as part of the diet in everyday life may lead to an increase in blood lactate levels (=primary outcome), triglycerides, and uric acid to a certain degree compared to baseline. however, this increase is expected to remain within a range that is not clinically relevant for adult patients, especially when fructose/galactose intake is not excessive and stays within the usual daily allowances for healthy individuals, as planned in this study.

Eligibility criteria:
inclusion criteria: * genetically and/or enzymatically confirmed diagnosis of gsdi (gsdia or gsdib) * male or female ≥ 18y * restriction of fructose intake in usual dietary treatment * written informed consent exclusion criteria: * non-compliance with routine dietary treatment * pregnancy or lactation * liver transplant * recurrent hospitalisations due to metabolic decompensation within the last 12 months * severe chronic kidney disease with glomerular filtration rate (gfr) \< 30 ml/min * for gsdib: severe, uncontrolled symptomatic inflammatory bowel disease

Keywords: gsd1 metabolism fructose galactose
topical cyclosporin a 0.05% eye drops for management of symptomatic acquired punctal stenosis. a prospective, controlled clinical study.

Conditions: Management of Punctal Stenosis

Summary: a prospective, controlled, interventional clinical study, includes all patients (16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis. all patients undergo punctal dilatation, canalicular probing and nasolacrimal duct irrigation. afterwards, patients are divided into two groups: group a: patients receive only medical treatment in the form of topical 0.05% cyclosporin (restasis®, allergan inc) twice daily for 6 months. group b: patients receive mini-monoka stent insertion in the lower canaliculus for 6 months. outcome measures are changes in munk scoring, grading of the punctum, functional and anatomical success. functional success is defined as munk score 0 to 1. anatomical success is defined as grade 3 punctum.


Eligibility criteria:
inclusion criteria: * the study includes all patients (more than 16 years) with symptomatic epiphora and diagnosed with grade 1 or grade 2 acquired punctal stenosis exclusion criteria: * patients presented with congenital epiphora, previous eyelid surgeries, neoplastic or traumatic causes of punctual or canalicular obstruction, or any other causes of lacrimal passage obstruction such as canalicular, common canalicular or nasolacrimal duct obstruction nldo are excluded from this study.

Keywords: cyclosporin, punctal stenosis, restasis, mini-monoka.
improving stroke care in greece in terms of management, costs and health outcomes-

Conditions: Cerebrovascular Disorders

Summary: the main objectives of the proposed project are: 1. to provide essential data on acute stroke management (quality indicators) incorporating hard clinical outcomes that will contribute to an ongoing process of quality improvement 2. to develop an interactive multichannel platform, for collecting, cleansing and curating high quality in-hospital and follow up data, applying multidimensional quality assessment analysis, providing statistical and analytic reports, monitoring behavioral changes and supporting overall project's management. 3. to evaluate patients' and physicians' experiences and their impact on stroke management. 4. to assess severe negative impact of stroke on the life of survivors including quality of life and disability 5. to measure health related and non- health (loss of productivity, informal care) related national expenditure for stroke care using a bottom up approach 6. to evaluate the value of care focusing on health outcomes compared with total costs of achieving them

a prospective cohort multicenter study of patients with first ever acute stroke, hemorrhagic and ischemic, (icd-10 codes: i61, i63 and i64) admitted within 48 hours of symptoms onset to seven nhs and university hospitals will be conducted. about 1,000 patients (2% of all new cases/annually) will be recruited from six urban and semi-urban areas with 5.5 mil people (50% of greek population), reporting 25,000 discharged stroke cases annually (53% of all stroke discharges), according to data derived from hellenic statistical authority. all patients will be followed for three months. moreover, a sub-group of the 300 firstly recruited patients will be followed for a year to obtain data on post hospital health and social needs, health services utilization (medication, rehabilitation, outpatient visits) and productivity loss . patient enrolment and follow up is estimated to last 18 months.

Eligibility criteria:
inclusion criteria: * diagnosis of hemorrhagic or ischemic stroke (icd-10: i61, i63 and i64) * patients with first ever acute stroke

Keywords: stroke stroke care stroke units value of stroke care
chongqing primary aldosteronism study

Conditions: Primary Aldosteronism

Summary: we intends to conduct a series of original clinical research about pa, and establish a large cohort of pa and essential hypertension patients with long-term follow-up of cardiovascular events, renal end points etc. we will establish a large sample of blood, urine, adrenal tissue of the subjects, and the genomics,metabonomics, proteomics database, to explore the mechanism of the pa and target organ damage, risk factors, diagnostic methods and biomarkers.

this study will include the subjects of a series of studies on hypertension conducted by our team, including essential hypertension, pa subjects, and establish a large sample database and specimen bank through follow-up and omics analysis.

Eligibility criteria:
inclusion criteria: 1. hypertensive patients who completed arr screening and necessary further tests; 2. voluntary to sign the informed consent. exclusion criteria: 1. patients with severe cardiac, hepatic or renal dysfunction; 2. suspicious or confirmed other types of secondary hypertension, including cushing's syndrome, pheochromocytoma and renal artery stenosis et al.

Keywords: primary aldosteronism cardiovascular events cerebrovascular events