Kornimate/medical-research-clean huggingface dataset:
the study of cm326 in patients with moderate-to-severe atopic dermatitis

Conditions: Moderate-to-severe Atopic Dermatitis

Summary: this is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, pk, pd, immunogenicity and preliminary efficacy of cm326 in moderate-severe ad subjects.

the study consists of 3 periods, a up-to-4-week screening period, a 12-week randomized treatment period and a 12-week safety follow-up period.

Eligibility criteria:
inclusion criteria: * with confirmed atopic dermatitis (ad) at least 12 months before the screening * eczema area and severity index (easi) score ≥16 at screening and baseline * investigator's global assessment (iga) score ≥3 at screening and baseline * body surface area (bsa) of involvement of atopic dermatitis ≥10% at screening and baseline * the weekly mean score of daily peaks in pruritus nrs at baseline ≥4 * provide signed informed consent exclusion criteria: * not enough washing-out period for previous therapy. * presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (hiv) infection, active hepatitis b, hepatitis c or parasitosis, neoplasm malignant, etc. * patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (ast) or alanine aminotransferase (alt) level \> 2 times of upper limit of normal (uln), total bilirubin \>1.5 times of upper limit of normal (uln) or serum creatinine level \> upper limit of normal (uln). * womens who are pregnant or breastfeeding, or who plan to become pregnant during the study.
optimization of deep brain stimulation parameters in patients with medically refractory epilepsy

Conditions: Refractory Epilepsy; Deep Brain Stimulation

Summary: deep brain stimulation (dbs) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. this therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. implantable neural stimulators (inss) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. this study will develop a platform for stimulation setting optimization based on power spectral density (psd) measures.


Eligibility criteria:
inclusion criteria: * medically refractory epilepsy * already have a deep brain stimulator in place exclusion criteria: * severe dementia at investigator discretion

Keywords: refractory epilepsy deep brain stimulation
effect of patient education in rheumatic diseases

Conditions: Polyarthritis

Summary: the purpose of this study is to explore the effect of patient education (pe) in patients with arthritis. pe has become a task that is dictated by law in norway, and is increasingly used as an element in the treatment of patients with chronic complaints. our hypothesis is that - pe delivered as group education, followed by an individual nurse consultation increases the patients wellbeing an ability to cope with the disease.

there has been a rather long tradition of pe for patients with arthritis. a recent systematic review found that pe had small short-term effects on disability, joint counts, patient global assessment, psychological status and depression, but this effect disappeared on the latest time of follow up (3-14 months). a recent large british study also failed to show an effect on pain, physical functioning, or contact with primary care after 12 months, but found a significant effect on anxiety and improved the participants' perceived self efficacy. this indicates that the present forms of interventions fails to show a long term effect. one possible reason for the lack of long term effect might be that these interventions are given to groups only. patients seem to prefer one-to-one interaction regarding information about the disease and its treatment together with emotional aspects, while education in groups are preferred for physical training and relational topics.

Eligibility criteria:
inclusion criteria: * polyarthritis * 18-80 years * native norwegian speaking * able to understand and participate in the pe program exclusion criteria: * participated in a patient educational program the latest 12 months

Keywords: patient education nurse consultation arthritis wellbeing coping health related quality of life
study to investigate pregnancy outcomes in female participants exposed to subcutaneous (sc) peginterferon beta-1a and intramuscular (im) interferon beta-1a reported in a german participant support program

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective(s) of the study is to evaluate the impact of exposure to sc peginterferon beta-1a or im interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the german patient support program (psp) and of whom a pregnancy report and pregnancy outcome report is available. the secondary objectives of this study are applicable for a subpopulation of the above-mentioned population, i.e. for participants of whom data on a standardized questionnaire collected during a telephone interview is available.

this is an observational study with focus on existing pregnancy reporting forms (retrospective part) and a patient's questionnaire which is completed at a single point of time (prospective part). main data source for the retrospective data (from 2014 until december 2019) will be captured from multiple sclerosis service-center (mssc) database, i.e. the entered pregnancy report (to be completed as soon as pregnancy becomes known) and pregnancy outcomes report (to be completed after completion of pregnancy). prospective data (december 2020 to 31 march 2021) will be captured as standardized epdf questionnaire completed during telephone interview. if the pregnancy report or the pregnancy outcome report is incomplete, i.e. the data above was not collected, the open questions will be addressed during a telephone interview performed by the mssc and the new information will be entered into the mscc database. the patient questionnaire will be completed at a single point of time during the telephone interview performed by the mssc.

Eligibility criteria:
inclusion criteria: * diagnosed relapsing-remitting multiple sclerosis (rrms) or clinically isolated syndrome (cis) (cis indication only applicable for interferon beta-1a) * exposure to either sc peginterferon beta-1a therapy or an im interferon beta-1a therapy before or during pregnancy * registered in the psp of the multiple sclerosis service- center (mssc) and agreed in writing to the privacy policy of the registration form * reported pregnancy data (pregnancy report and pregnancy outcome report) available at mssc. note: only pregnancy data (i.e. obtained until 15 october 2020) will be considered. * pregnancy outcome in the retrospectively collected data was a live birth exclusion criteria: any criteria that does not fulfil the above-mentioned inclusion criteria. note: other protocol defined inclusion criteria may apply
myocardial inflammation in systemic lupus erythematosus

Conditions: SLE

Summary: the goal is to assess for myocardial edema on cardiac mri during sle flare to assess for myocardial inflammation.

the over-arching goal of this work is to further the understanding of myocardial damage in systemic lupus erythematosus (sle) using state of the art cv imaging to investigate a novel potential mechanism of cv injury in sle, subclinical myocardial inflammation. aim 1: investigate an alternative pathway for cv morbidity in sle by measuring myocardial edema at time of moderate to severe flare and compare values to post-flare studies and historical healthy controls. hypothesis 1: myocardial edema, measured quantitatively with t2 cmr mapping during moderate to severe sle flare will be significantly increased compared to 1) historical controls and 2) in sle patients after resolution of flare. aim 2: perform exploratory analyses investigating relationships between myocardial edema on cmr and markers of sle disease activity and cv risk factors. hypothesis 2: markers of disease activity including inflammatory makers (esr and high sensitivity c-reactive protein), complement and autoantibody levels will predict the presence of t2 cmr detected myocardial edema during flare.

Eligibility criteria:
inclusion criteria: * • diagnosis of sle by american college of rheumatology classification criteria \[21\] * active sle flare defined by systemic lupus erythematosus disease activity index (sledai)\[22\] \> 6 or british isles lupus assessment group (bilag) index a or b.\[23\] exclusion criteria: * pregnant * allergy to gadolinium * severe claustrophobia * renal replacement therapy or glomerular filtration rate (gfr) \< 30 ml/min/1.75m² * medically unstable for transportation to ross mri scanner. stability will be defined as: not on mechanical ventilation, hr \ 65 mmhg. the treating providers' input on the patient's stability will also be considered in addition to these criteria * weight \> 500 pounds * mr incompatible implanted devices such as neurostimulator pacemakers and implantable defibrillators, presence of intracranial metal or any metal not compatible with cmr
safety and acceptability study of non-occupational prophylaxis (pep) following potential exposure to hiv

Conditions: HIV

Summary: this study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing hiv transmission after a high-risk sexual contact exposure in hiv uninfected adults.

participants are given a regimen containing tenofovir disoproxil fumarate (tdf) 300mg and emtricitabine (ftc) 200mg fixed-dose combination tablet (tdf/ftc) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily,for 28 days.

Eligibility criteria:
inclusion criteria: 1. age of 18 at time of first visit. 2. hiv uninfected on the basis of a negative hiv rapid test 3. possible non-occupational exposure to hiv-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. exclusion criteria: 1. women who are actively trying to become pregnant. 2. pregnancy and/or breastfeeding. 3. known self report of chronic hepatitis b infection or prior antiretroviral therapy for hepatitis b. 4. known intolerance or allergy to study drugs.

Keywords: hiv prevention non-occupational post-exposure prophylaxis (npep) post-exposure prophylaxis (pep)
expression of markers related to mitochondrial functionality in carcinoma of the urinary bladder: comparative retrospective analysis between recurrent tumors ("non-responders") and non-recurrent tumors ("responders") after intravesical treatment with chemotherapy or immunotherapy

Conditions: Bladder Cancer

Summary: retrospective monocentric study evaluating different immunohistochemical phenotypes related to mitochondrial functions with treatment outcomes

about 80% of newly diagnosed patients have non-muscle-invasive bladder cancer (nmibc), including papillary lesions confined to the urothelium (stage ta) or invading the lamina propria (stage t1), and carcinoma in situ (cis). these tumors show low progression rates, but high recurrence. in particular, patients with multifocal high-grade urothelial carcinoma have a high risk of both recurrence (∼70% after 1 yr) and progression (5% after 1 yr). initial nmibc management is a transurethral resection of bladder tumor (turbt), followed by adjuvant intravesical treatment with the chemotherapeutic agent mitomycin c (mmc) or the immunotherapy bacillus calmette-guérin (bcg). however, these therapies lead to variable clinical responses and patients recur shortly after surgery. despite both therapies have been used for decades in the treatment of nmibc, at the moment it is not possible to predict after initial staging which patients will benefit from them since neither resistance mechanisms nor genetic markers associated to relapse have been identified yet. in a preliminary analysis, the invesitigators found that low expression of several proteins involved in mitochondrial functions correlate with a worst prognosis in bladder cancer patients. the aim of this study is to detect markers of mitochondrial dysfunction by immunohistochemistry in recurrent tumors ("non-responders") and non-recurrent tumors ("responders") after intravesical treatment with chemotherapy or immunotherapy, and determine the prognostic relevance of these different markers.

Eligibility criteria:
inclusion criteria: * \>18 years of age at diagnosis * histologically confirmed nmibc urothelial carcinoma of the urinary bladder (pta, pt1, cis) * primary nmibc or not treated secondary nmibc, after a primary non-invasive malignancy * patients underwent turbt for nmibc at humanitas between 2000 and 2019 * patients that received intravesical instillations with either mmc or bcg after turbt at humanitas between 2000 and 2019 * written informed consent to research purpose * for non-recurrent tumors ("responders"): * patient treated with adjuvant mmc or bcg that did not experience recurrence for at least 42 months after turbt * patients are tumor-free at the moment of the analysis * for recurrent tumors ("non-responders"): * patient treated with adjuvant mmc or bcg that experienced recurrence in the first 24 months after turbt. exclusion criteria: * previous malignancies other that bladder cancer * patients with a history of treated bladder cancer recurrences
exenatide plus pioglitazone versus insulin in poorly controlled t2dm

Conditions: Type 2 Diabetes

Summary: to compare efficacy, safety and durability of combination therapy with pioglitazone plus glp-1 ra versus basal bolus insulin in poorly controlled t2dm patients on metformin plus sulfonylurea

poorly controlled (hba1c \>7.5%) t2dm patients (18-75 years of age) on maximal/near maximal dose of sulfonylurea plus metformin who otherwise are healthy will be randomized to receive: 1. exenatide weekly injection (2 mg/week) 2. glargine insulin plus insulin aspart which will be titrated to maintain hba1c \<7.0%

Eligibility criteria:
inclusion criteria: * t2dm poorly controlled (hba1c \>7.5%) on metformin (\>1700 mg/day) plus sulfonylurea exclusion criteria: * type 1 diabetes (t1dm) patients receiving therapy with pioglitazone, glp-1 ra and insulin abnormal kidney, liver or heart function patients with malignancy
the feasibility of performing erector spinae (esp) nerve block in bariatric patients; a case series study

Conditions: Nerve Pain

Summary: this study is a pilot study to assess the effectiveness of erector spinae (esp) nerve blocks for postoperative pain control following bariatric surgery. currently, there are mainly case series/pilot studies describing the use of esp nerve blocks for postoperative pain control in abdominal procedures; of these only one uses this treatment modality for bariatric procedures. the population undergoing bariatric surgery poses specific challenges to postoperative pain management. they often have comorbid obstructive sleep apnea, which puts them at greater risk for ventilatory depression when treated with parenteral opioids. this risk can be reduced with regional techniques. the esp nerve blocks provide visceral and somatic pain coverage as opposed to the more commonplace transversus abdominis plane nerve block which only provides somatic coverage. this means that the esp nerve blocks will cover incisional pain as well as the discomfort associated with the pain from the procedure itself. this study intends to build on current knowledge by proving that the use of esp in the post-operative are providing a significant reduction in pain scores as well as reducing the need for parenteral opioids. thus, decreasing the risk of postoperative ventilatory complications. in preparation for this study, three pilot studies were reviewed. the studies assessed the usefulness of esp nerve blocks on patients undergoing abdominal surgery. single-shot bilateral esp blocks were performed in the first two studies. one of the studies, patients undergoing ventral hernia repair and the other for patients undergoing bariatric surgery. the third pilot study used bilateral esp blocks followed by a continuous infusion on one patient undergoing an open prostatectomy with bladder reconstruction. all the esp blocks were placed preoperatively at the t7 transverse process. in the studies using a single shot technique 20-30 ml of ropivacaine 0.5% was used. for the continuous esp catheter an initial bolus of bupivacaine 0.25% 10 mls followed by continuous infusion rate of 6 ml/hr bilaterally. all showed a significant reduction numerical rating scale (nrs) as a primary outcome. the secondary outcome of reduced 24-hour parenteral opioid consumption was also achieved by all three studies.


Eligibility criteria:
inclusion criteria: * age range 21 - 70. * asa ii: a patient with mild systemic disease-asa iii: a patient with severe systemic disease * patients included are those immediately postoperative from bariatric surgery who have an nsr pain score \>5 exclusion criteria: * patients excluded are those who are asa iv or greater, refuse nerve block intervention, * diagnosis of any coagulopathy disorder, * allergy to local anesthetics, * have active infection over proposed injection sites. * patients with asa \>iii was excluded due to overall health concerns of poorly controlled chronic disease.
dichotic listening as a predictor of medication response in depression

Conditions: Major Depression; Dysthymia; Depressive Disorder Not Otherwise Specified

Summary: depressed patients will have hearing tests and then be treated with up to three treatments (i.e., fluoxetine, imipramine) until remitted, to see whether test results predict specific outcomes.

100 depressed patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with fluoxetine and imipramine until remitted. preferential hemisphere for auditory processing will be correlated with treatment outcome.

Eligibility criteria:
inclusion criteria: * ages between 18-65 * meets diagnostic and statistical manual, 4th edition criteria for current major depression, dysthymia or depression not otherwise specified exclusion criteria: * known hearing impairment * active suicidal ideation (history of suicide attempts will be evaluated on a case by case basis) * hamilton rating scale for depression, 17-item version \> 20 * current (past six months) alcohol and/or drug abuse or dependence * medical condition likely to require intervention contraindicated with study medication (e.g., known arrhythmia likely to be exacerbated by imipramine) * bipolar i * psychosis * if currently taking antidepressants or mood stabilizers, cannot be off psychotropic medication for 7 weeks (10 weeks for prozac) or felt to require other psychiatric medication (other than occasional sleep or anxiety medication) * premenopausal women not using known effective birth control * not currently depressed (whether considered due to current treatment or not) * nonresponse to adequate trial of both study medications (i.e., \> 4weeks on \> escitalopram 30 mg/d, and imipramine 200 mg/d); patients having an inadequate response to one study medication could be enrolled and receive the other; patients having responded to an adequate trial of either study medication would be offered a retrial; also excluded will be subjects having non responded to an adequate trial with citalopram (i.e., \> 4 weeks on \> citalopram 60 mg/d) * left-handed

Keywords: major depression dysthymia depression not otherwise specified dichotic listening fluoxetine imipramine predictors
study to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa (true-hs1)

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.


Eligibility criteria:
inclusion criteria: * diagnosis of hs for at least 6 months prior to screening visit. * mild to moderate hs (hurley i or ii) with the following at both screening and baseline visits: * a total an count of at least 4, with no draining tunnels and * affecting at least 2 distinct anatomical areas * agreement to not use topical and systemic antibiotics for treatment of hs during the vehicle-controlled period. * agreement to not use topical antiseptics, including washes and leave-on products on the areas affected by hs lesions during the vehicle-controlled period and weeks 16 to 20 of the extension period. * further inclusion criteria apply. exclusion criteria: * body surface areas to be treated exceed 20% bsa at screening or baseline * presence of draining tunnels at screening or baseline. * medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * laboratory values outside of the protocol-defined criteria. * pregnant or lactating participants, or those considering pregnancy during the period of their study participation. * further exclusion criteria apply.

Keywords: hidradenitis suppurativa skin disease ruxolitinb cream