Kornimate/medical-research-clean huggingface dataset:
canadian active & maintenance modified pentasa study

Conditions: Active Ulcerative Colitis; Remission of Ulcerative Colitis

Summary: the purpose of this study is to demonstrate that the new modified oral extended-release pentasa® 500mg tablet is at least as efficacious as the currently marketed pentasa® 500mg tablet in active mild to moderate ulcerative colitis (uc) and also in maintenance of quiescent disease.

a multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release pentasa® (mesalamine) 500 mg tablet to the currently marketed pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. the study involves male or non-pregnant female subjects aged 18 to 75 years. subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week active phase or the 4-week run-in phase, they were eligible for enrolment into the 24-week maintenance phase, remaining on the original randomised treatment.

Eligibility criteria:
inclusion criteria for active phase: * newly diagnosed or recurrent, mild to moderate ulcerative colitis patients. * extent of colonic involvement confirmed within the past 36 months * ucdai score of at least 3 but not greater than 8 and a score of at least 1 for endoscopy * screening tests to rule out any abnormalities in stool, heart or kidney. * male or non-pregnant females between 18 to 75 years. * women of childbearing potential to use efficacious contraception as judged by the investigator. * written informed consent given. inclusion criteria for maintenance phase: * newly recruited subjects with documented mild to moderate uc entering the run-in phase: in clinical remission for at least 1 month and for a maximum of 3 years, and receiving 5-asa 1.4 to 2.5 g/day for maintenance of quiescent disease * subjects from active phase: meeting remission criteria after the 8-week active period * extent of colonic involvement confirmed within the past 36 months by colonoscopy * in complete remission at entry into the maintenance phase, defined as i) a score of 0 or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for endoscopy findings; and iv) a physician's global assessment (pga) score of 0 or 1 * screening tests to rule out any abnormalities in stool, heart or kidney. exclusion criteria: * use of 5-asa products at a dose \>2.5g/day within 7 days prior to entry. * proctitis, short bowel syndrome, prior bowel surgery, severe uc, other forms of inflammatory bowel disease * infectious diseases, parasites, bacterial pathogens * allergy to aspirin or salicylate * liver or kidney abnormalities * alcohol or drug abuse * pregnancy * cancer * bleeding disorders, ulcers, autoimmune diseases * mental disorders * participation in clinical trial in last 30 days * inability to fill in diary cards / comply with protocol requirements

Keywords: ulcerative colitis 5-aminosalicylate
cadisegliatin as adjunctive therapy to insulin in participants with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: this is a phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with type 1 diabetes mellitus.

study ttp399-302 is a 26-week, phase 3 trial designed to measure the relative efficacy of adjunctive treatment with cadisegliatin to reduce the incidence of level 2 or level 3 hypoglycemia in participants with type 1 diabetes mellitus compared to placebo (insulin alone) over 26 weeks of continuous therapy.

Eligibility criteria:
inclusion criteria: * individuals ≥18 years * diagnosed t1dm with a minimum of 5 years since diagnosis * has had at least 1 hypoglycemic event of level 2 (glucose level \<54 mg/dl or \<3 mmol/l, \[cgm or smbg confirmed\]) or level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to screening * hba1c value of \<9.5% at screening * is currently on csii (closed-loop systems are prohibited) or is on mdi for at least 6 months prior to the screening visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (csii or mdi injection treatments) for the duration of the study * must have used a cgm device for at least 3 consecutive months prior to screening exclusion criteria: * has t2dm, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease * has been hospitalized for dka within 3 months prior to screening * has uncontrolled hypothyroidism or hyperthyroidism * history of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight * has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ * has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (sglt-2) inhibitors, glucagon-like peptide-1 (glp-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (dpp-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) within 90 days prior to the screening or weight loss medications within 30 days prior to the screening * has used a hybrid closed-loop system (e.g., medtronic 670g, omnipod 5, or tandem x2 with control iq) or do-it-yourself looping within the last 30 days prior to the screening visit, and agrees to not start hybrid closed-loop systems or do-it-yourself looping during the study. * has an estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2 utilizing the chronic kidney disease epidemiology collaboration (ckd-epi) equation at screening * has uncontrolled hypertension prior to screening
iterative redesign of a behavioral skills training program for use in educational settings

Conditions: Autism Spectrum Disorder; Disruptive Behavior

Summary: this study proposes to redesign the rubi parent training program, a low-intensity intervention for youth with autism spectrum disorder and disruptive behavior, for use by school personnel in the classroom. using a mixed-methods approach, 40 school staff members from 20 elementary schools will be recruited to inform current classroom behavior management practices and rubi redesign needs.

approximately 50% of children with autism spectrum disorder (asd) exhibit disruptive behaviors such as tantrums, aggression, and noncompliance that significantly impact social, adaptive, and academic functioning. the rubi program is an evidence-based parent-mediated intervention that improves disruptive behavior in children with asd. considering schools serve as the primary intervention setting for children with asd, and teachers and school staff often struggle to address challenging behavior, there is an opportunity to meaningfully improve care by adapting rubi for delivery in schools. to address these needs, the discover, design/build, test (ddbt) framework,which leverages user-centered design and implementation science, will be used to engage 40 end users from 20 elementary schools to inform current classroom behavior management practices and redesign needs for the rubi curriculum to ensure that the modified curriculum (rubi in educational settings; rubies) is useful and useable for school personnel who work with children with asd. specific aims include: aim 1: identify the contextual constraints and end users (teachers, school psychologists, behavior technicians, classroom aides) relevant to the management of disruptive behavior in the classroom. through in-class behavioral observations and interviews, aim 1 will allow us to understand the values and priorities of the school context and end users directly involved with children with asd (e.g. resources, work flow, policies). aim 2: identify targets for rubi redesign. using in-depth intervention demonstration of rubi paired with behavioral rehearsal, prospective think-aloud, and structured assessment methods, aim 2 will allow us to determine which rubi components should be retained, eliminated, or modified to address the needs of the context and end-users identified in aim 1. aim 3: iteratively adapt rubi content and procedures based on identified targets for redesign and continual user testing to improve the hypothesized mechanisms of redesign (usability) and perceptual implementation outcomes (feasibility, acceptability, and appropriateness). aim 3 will allow us to determine the extent to which redesigned rubi, or rubies, improves usability and implementation outcomes.

Eligibility criteria:
inclusion criteria: * elementary school (kindergarten through 5th grade) personnel (i.e. general and special education teachers, school psychologist, paraprofessionals) * works with at least one student with asd for part of the day exclusion criteria: -school personnel who do not have contact with youth with asd during the work day
lu's acupuncture and moxibustion treatment on stroke

Conditions: Ischemic Stroke; Paralysis

Summary: there will be successive changes in traditional chinese medicine rehabilitation for stroke patients with limb hemiparetic through therapy of acupuncture and moxibustion.

there will be difference in stroke outcomes of ischemic stroke patients with limb hemiparetic from acute to chronic phase under lu' acupuncture and moxibustion.

Eligibility criteria:
inclusion criteria: * the ages of stroke patients from 40 years old to 70 years old. * the principle diagnosis according to \ formulated by collaboration acute brain diseases of state administration of traditional chinese medicine in 1996；ischemic stroke confirmed by ct brain or mri brain,with stable medical condition and awareness clear. * recent stroke from 7 days to 6 months after onset. * stroke with limb movement disorder and hypomyotonia，nihss≤10，ashworth≤1，gcs\>8. * written informed consent by inpatient. exclusion criteria: * stroke with conscious disturbance or serious cognitive impairment. * stroke with limb spasm；ashworth≥1. * having cardiac pacemaker，metallic foreign body in treatment position，or hemorrhagic tendency. * being oversensitive to electrical stimulus.
dexmedetomidine combined with lidocaine infusion affect inflammation cytokines

Conditions: Anesthesia; Reaction

Summary: objective: the present study was to evaluate the effects of dexmedetomidine alone, lidocaine alone and their combined infusion on postoperative inflammation cytokines after laparoscopic hysterectomy. methods: investigators enrolled 160 women with american society of anesthesiologists (asa) physical status i and ii, aged 40-65 years, and scheduled for elective laparoscopic hysterectomy with general anesthesia from october 2017 to august 2018. the participants were randomly assigned into four groups(n=40 each group): group con received normal saline infusion, group lido received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion), group dex received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and group lido+dex received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). the four groups received an iv bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a continuous iv infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine until abdominal wound closure, respectively. interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (t1), the end of surgery (t2), postoperative 2 hour (t3) and postoperative 24 hour (t4).


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i and ii * weighted 50 kg-65 kg * aged 40-65 yr * elective laparoscopic hysterectomy with general anesthesia exclusion criteria: * a history of allergy to local anesthetics * severe respiratory, renal or hepatic disease * preoperative opioids medication * psychiatric medical history * patients with severe hypotension \[mean arterial pressure (map\<60 mmhg)\] or bradycardia \[heart rate (hr) \<40 beats per minute (bpm)\], arrhythmia, or urticaria due to lidocaine and dexmedetomidine infusion during the surgery

Keywords: dexmedetomidine; lidocaine; cytokine
comparative analysis of intra-articular injection of steroid and/or sodium hyaluronate in adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: the purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.


Eligibility criteria:
inclusion criteria: * clinical diagnosis : adhesive capsulitis of the shoulder * defining of adhesive capsulitis * the presence of shoulder pain * limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder * duration : symptomatic for \< 1 year exclusion criteria: * bilateral symptoms * uncontrolled diabetes mellitus * overt hypothyroidism or hyperthyroidism * previous shoulder surgery * previous glenohumeral joint injection within recent 6months * trauma to the shoulder the last six months that required hospital care * neurological symptoms * allergy to injection material * secondary adhesive capsulitis * systemic inflammatory ds including rheumatoid arthritis * degenerative arthritis of shoulder joint * infectious arthritis of shoulder joint * dislocation of shoulder joint * blood coagulation disease * rotator cuff tear * serious mental illness * pregnancy * fracture in shoulder lesion * cva
evaluation of clinical, perceived and instrumental efficacy of a scar gel in preventing hypertrophic scars

Conditions: Acceptability Study; Real-use Conditions; Safety and Efficacy; Topical Administration; Hypertrophic Scars; Keloid Scars

Summary: evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use, comparing it to a benchmark for preventing hypertrophic scars and improving appearance, hydration and pigmentation.

evaluation of the safety and topical efficacy of a scar gel after 90 days of continuous use. comparison of the efficacy of the investigational product with the benchmark product in preventing hypertrophic scars and improving scar appearance, as well as analyzing parameters such as skin hydration, pruritus, discomfort, and normalization of scar pigmentation.

Eligibility criteria:
inclusion criteria: 1. participants of both sexes aged between 18 and 70 years; 2. participants with recent scars (\<30 days); 3. participants with phototypes iii to vi according to the fitzpatrick scale; 4. agree to follow the trial procedures and attend the center on the days and times determined for evaluations; 5. understand, agree to and sign the free and informed consent form. 6. types of scars: cesarean section, breast implant or blunt cut injury. exclusion criteria: 1. pregnancy or risk of pregnancy; 2. history of atopic or allergic reactions to cosmetic products; 3. participants who are using topical antibiotics or other skin products on the same area being evaluated; 4. immunosuppression due to drugs or active diseases; 5. decompensated endocrine diseases; 6. relevant clinical history or current evidence of alcohol or other drug abuse; 7. known history or suspected intolerance to products in the same category; 8. intense sun exposure up to 15 days before the evaluation; 9. patients who are using topical antibiotics or other skin products on the same area being evaluated.
relationship between ebv and ptld

Conditions: Pediatric Heart Transplant

Summary: the purpose of this study is to determine the significance of an elevated quantitative ebv pcr and to determine the relationship between a ebv pcr value and the risk of developing ptld.

the relationship between epstein-barr virus and lymphoproliferative disease has been established, particularly in the immuno-suppressed patient. over the past several years a quantitative ebv pcr lab test has been established. unfortunately, the significance of an elevated test remains unclear. the relationship of a particular ebv pcr value and the risk of developing ptld is unknown. the primary aims will be to determine the significance of an elevated quantitative ebv pcr and to determine the relationship between a ebv pcr value and the risk of developing ptld. the study will be conducted through a retrospective chart review of approximately 160 patients and we will look at postoperative data including quantitative ebv pcr results, the presence / absence of ptld and the treatment of ptld and results of ebv pcr with treatment.

Eligibility criteria:
inclusion criteria: * patients undergone pediatric heart transplant * followed by pediatric heart transplant program exclusion criteria: -

Keywords: epstein-barr virus pediatric health cardiac heart transplant lymphoproliferative disease post-transplant pediatric transplant
a study to evaluate the efficacy and safety of tacrolimus with steroid in korean lupus nephritis patients

Conditions: Lupus Nephritis

Summary: this study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.


Eligibility criteria:
inclusion criteria: * patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ara criteria, 1982) * patients who fall under who class iii-iv lupus nephritis on renal biopsy * patients with refractory lupus nephritis * proteinuria ≥ 0.5 g/day * patients who took steroid ≥ 20 mg/day over one month prior to the study * patients who failed a first-line therapy (non-responders to steroid monotherapy) exclusion criteria: * patients who are allergic or resistant to macrolide antibiotics or tacrolimus * patients who received tacrolimus in the past (excluding drugs for external use) * patients who used other immunosuppressants within 4 weeks before initiation of the study * patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.) * patients with malignant tumor which developed within the recent 5 years or history of malignant tumor * patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus * patients with s-cr ≥ 200 µ㏖/l or ≥ 2.3 mg/dl * patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis

Keywords: tacrolimus prograf fk506 proteinuria calcineurin inhibitor
registry of patients with acute dyspnea in the emergency department

Conditions: Dyspnea; Heart Failure; COPD

Summary: this is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in nuremberg. there is evidence that acute dyspnea is associated with a mortality rate of 10%, however acute dyspnea is not perceived as a life-threatening condition, both in public and in health care providers. our aim is to describe the patient collective concerning their demographics, baseline characteristics, type of referral and disposition, medical care processes and prognosis. secondly, we want to evaluate if the subjective risk assessment of emergency department personnel matches with objective risk stratification tools and the actual outcome of the studied patients.

this is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in nuremberg during may 23th 2013 and october 31th 2013. to be included into the registry the patient has to express acute dyspnea. minor patients are not included. the admission documents of the studied patients are accompanied by a questionnaire that has to be completed by the triage nurse and the attending physician. the questionnaire includes items like professional experience and subjective assessment of patient's prognosis. in addition the attending physician has to state if the evaluation of medical history was difficult, if previous medication is known and how likely the presence of heart failure as underlying condition is. data of the questionnaire, the patient record and the follow up contacts are entered in a spss database. finally, we measure the optimize-hf score (abraham et al. 2008) and the pride mortality score (baggish et al. 2007) in a retrospective manner in order to compare the subjective assessments with objective criteria.

Eligibility criteria:
inclusion criteria: * expression of acute dyspnea in the emergency department exclusion criteria: * age \< 18 years

Keywords: dyspnea registry baseline characteristics mortality risk assessment emergency department
comparison of four different regimens of adapalene 0.1% / benzoyl peroxide 2.5% gel in acne vulgaris

Conditions: Acne

Summary: the purpose of this study is to compare the tolerability of 3 treatment regimens containing adapalene 0.1% / benzoyl peroxide 2.5% gel with that of adapalene 0.1% /benzoyl peroxide 2.5% gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. the efficacy of the four treatment regimens will also be evaluated.


Eligibility criteria:
inclusion criteria: * male or female subjects of any race, aged 12 to 35 years inclusive * subjects with mild or moderate facial acne vulgaris * subjects with skin phototype i to iv exclusion criteria: * subjects with more than 1 nodules or cysts on the face, * subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Keywords: acne