Kornimate/medical-research-clean huggingface dataset:
alpha lipoic acid in ulcerative colitis

Conditions: Ulcerative Colitis; Ulcerative Colitis (UC)

Summary: this study aims at evaluating the efficacy and safety of alpha-lipoic acid as adjuvant therapy to mesalamine in patients with mild to moderate ulcerative colitis due to its effect as anti-oxidant and anti-inflammatory drug which can help to improve disease.


Eligibility criteria:
inclusion criteria: * age ≥18 years old. * both male and female sex. * newly diagnosed patients with active mild and moderate ulcerative colitis according to american college of gastroenterology (acg) clinical guideline for diagnosing ulcerative colitis in adults.26 * patients treated with 5-aminosalisylic acid (mesalamine). exclusion criteria: * patients with severe ulcerative colitis. * patients with colorectal cancer. * patients on rectal or systemic steroids. * patients on immunosuppressants or biological therapies. * patients with previously failed treatment with sulphasalazine. * patients with known allergy to study medications. * history of complete or partial colectomy. * patients with significant liver disease (fibrosis, cirrhosis, nash, nafld). * patients with other inflammatory diseases. * patients with thyroid diseases. * patients with arrhythmia, ischemic heart disease, and heart failure. * patients with diabetes. * patients on antioxidants supplement (vitamin a, c, e), selenium, co-enzyme q. * patients on amlodipine, levothyroxine, low strength aspirin, warfarin, atorvastatin, insulin, oral hypoglycemic, chemotherapy (drug-drug interaction).
timing of renal replacement therapy in mechanically ventilated patients

Conditions: Timing of RRT in Mechanically Ventilated Patients

Summary: this is a randomized controlled study that will be conducted on acute kidney injury (aki) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (rrt) compared to late rrt on patients outcome.

the study subjects will be randomly divided into two groups (arms). the first one will be patients who will receive early renal replacement therapy (rrt) according to predefined criteria that will be illustrated later. the other group of patients will be those who receive late rrt according to the absolute indications of emergency hemodialysis i.e. severe hyperkalemia, life-threatening acidosis, uremic encephalopathy or pericarditis in addition to intractable pulmonary edema. appropriate randomization technique will be applied. a computer-based program will be used to perform the randomization procedure.

Eligibility criteria:
inclusion criteria: * all patients must be on invasive mechanical ventilation. * patients in aki stage 2 , according to kdigo classification. * recruited subjects will include either those who present with aki on their icu admission or those who develop aki during their icu stay exclusion criteria: * those who are known to be in grade 5 ckd according to kdigo classification. all other grades of ckd from 1 to 4 will be included only if they develop or present with stage 2 aki on top of their ckd grade * those who develop aki due to obstructive or traumatic causes. * patients with septic shock who are on high doses of vasopressors or inotropes (norepinephrine infusion more than 1 mcg/kg/minute, dopamine or dobutamine infusion more than 5 mcg/kg/minute). * pregnant females

Keywords: early and late rrt aki mechanical ventilation
do hostility and stress predict cardiovascular mortality in mrfit?

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Depression

Summary: to test the hypothesis that high levels of hostility, depressive symptoms, and stressful life events would be associated with all cause and cardiovascular disease (cvd) mortality after 16 years of follow-up in the multiple risk factor intervention trial (mrfit).

background: mrfit was a randomized, multicenter primary prevention trial designed to determine whether a special intervention consisting of smoking cessation, cholesterol reduction and control of high blood pressure, would result in a significant reduction in coronary heart disease (chd) mortality, compared to usual care. the study presented a unique opportunity to test in a cost-efficient manner the association of psychosocial factors and mortality in a large, well characterized sample of middle-aged men. design narrative: the sample was composed of 12,866 men who at the time of study entry were in the top 15 percent of a risk score distribution based on the framingham heart study data, but had no clinical evidence of chd. during the trial, annual measurements were taken, which included some health behaviors, stressful life events, feelings of anger and hostility. a subset of 3,110 men also were administered once the type a structured interview from which potential for hostility could be rated and all men who survived until the sixth year of the trial were administered the ces-depression scale. after approximately seven years of the active phase of the trial, the men were followed for an additional 9 years for mortality and cause of death. to test the major study hypotheses, the investigators coded all type a structured interview tapes for potential for hostility, and components of hostility (style, intensity, content) and constructed and validated a self-report measure of hostility from items administered to all participants. cox proportional hazard regression techniques were used to test the association of hostility, depression, and stressful life events with all cause and cvd mortality. if the major study hypotheses were confirmed, then educational attainment, baseline risk factors, change in risk factors, and adherence indicators would be included in subsequent analyses. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
treatment of hepatitis b in resource-limited settings - a pilot program in east africa

Conditions: Hepatitis B

Summary: viral hepatitis kills nearly one million people each year, even though effective treatment exists. the aim of this study is to establish a treatment protocol for hepatitis b, which is simple and cheap enough to be implemented in resource-limited settings.

chronic viral hepatitis is a major health problem globally. each year nearly one million deaths are attributable to either hepatitis b or c. in ethiopia 5-10% of the general population are infected with hepatitis b. oral antiviral treatment of hepatitis b exists, but high costs and advanced laboratory requirements have been barriers to offer such treatment in resource-limited settings, resembling the situation in treatment of hiv/aids a decade ago. the present study will investigate a simplified approach to hepatitis b treatment in resource-limited settings, inspired by the recent success of hiv treatment in such settings. the critical research question is how to identify patients with expected benefit of treatment in the absence of advanced laboratory support. a who expert panel recently suggested treatment criteria for use in settings without advanced laboratory facilities, but these criteria have not yet been tested out in real life. the present study will build on and develop the who approach to treatment of hepatitis b, aiming to develop a treatment protocol that can be feasible in other resource-limited countries. the potential public health benefit for poor people in low- and middle-income countries is substantial.

Eligibility criteria:
inclusion criteria: * consenting adults (≥18 years) residing in ethiopia who are hbsag positive exclusion criteria: * children \<18 years, other terminal disease (cancer etc.)

Keywords: liver cirrhosis antiviral agents liver diseases
orexin gene in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the objectives of this study will be to determine the methylation of the promoter of the orexin a (ox-a) and b (ox-b) genes in young women (\> 18 years) with anorexia nervosa (an), compared with a control group; and to evaluate the relationship of promoter methylation of the genes for ox-a and ox-b with the severity of the eating disorder, psychiatric comorbidities (in particular, depression), and sleep quality.


Eligibility criteria:
patients with anorexia nervosa: inclusion criteria: * female sex * age 18 years and older * anorexia nervosa * hospitalized at the division of eating and nutrition disorders, istituto auxologico italiano, irccs, piancavallo, italy exclusion criteria: * absence of signed informed consent control group: inclusion criteria: * female sex * age 18 years and older * body mass index between 18.5 and 24.9 kg/m2 exclusion criteria: * absence of signed informed consent * presence of any physical and mental pathology

Keywords: orexins methylation epigenetics psychiatric comorbidities eating disorder quality of sleep
individualizing anti-inflammatory medications for adults with axial spondyloarthritis: a series of n-of 1 trials

Conditions: Axial Spondyloarthritis

Summary: the purpose of this study is to compare selective cyclooxygenase-2 (cox-2) and non selective cox inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (axspa),to compare selective cox-2 and nonselective cox inhibitors impact on health related quality of life (hrqol) and how this relates to changes in disease activity and to conduct proteomic assessment of predictive biomarkers of non steroidal anti-inflammatory drug(nsaid) response


Eligibility criteria:
inclusion criteria: * patients must meet modified new york classification and/or assessment of spondyloarthritis international society (asas) criteria for classification criteria for axspa * ankylosing spondylitis disease activity score greater than or equal to 2.1. exclusion criteria: * changing background biologic/disease modifying-rheumatic medications within less than 3 months. * opioid medication use * current or expected pregnancy * history of cardiovascular disease (previous stroke, myocardial infarction, or percutaneous intervention. * end stage liver disease * chronic kidney disease greater than stage iiib

Keywords: spondylitis
a bridging study of pf-06439535 (cn) plus paclitaxel-carboplatin versus bevacizumab plus paclitaxel-carboplatin in nsclc

Conditions: Advanced Non-squamous NSCLC

Summary: the current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of pf-06439535 (cn) in combination with paclitaxel and carboplatin versus bevacizumab sourced from the european union (bevacizumab-eu) with paclitaxel and carboplatin in chinese participants with advanced non-squamous nsclc in the first-line treatment setting.


Eligibility criteria:
inclusion criteria: * male and female participants age at least 18 years of age. * newly diagnosed stage iiib, iiic or iv non small cell lung cancer (nsclc) (according to american joint committee on cancer (ajcc) staging manual, 8th edition, last updated 05 june 2018) or recurrent nsclc. * histologically or cytologically confirmed diagnosis of non-squamous nsclc. * at least one measurable lesion as defined by recist v1.1. * be eligible to receive bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous nsclc. exclusion criteria: * small cell lung cancer (sclc) or combination sclc and nsclc. squamous-cell tumors and mixed adenosquamous carcinomas. * evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that, in the opinion of the investigator, is likely to bleed. * known egfr activating mutations (for example, exon 19 deletion or exon 21 l858r substitution mutations) or alk rearrangements. * prior systemic therapy for advanced nsclc; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
digital interventions to understand and mitigate stress response

Conditions: Distress, Emotional; Stress Response Among Nursing Professionals During the COVID-19; Stress Reaction; Acute

Summary: stress, anxiety, distress, and burnout are exceptionally high among healthcare workers at the frontline of the covid-19 pandemic. the understanding of factors underlying distress and resilience in complex workplace contexts is limited, and there are limited evidence-based interventions for stress and moral distress among frontline healthcare workers. the purpose of this study is to use a digital intervention suite (a combination of virtual reality \[vr\], a web-based platform, and a wearable \[oura ring\]) to understand and reduce the experience of stress/distress faced by nursing professionals.

the purpose of this study is to use a digital intervention suite (a combination of virtual reality \[vr\], a web-based platform, and a wearable \[oura ring\]) to understand and reduce the experience of stress/distress faced by nursing professionals. this study involves participation in an in-person vr setup and the use of an app and a wearable device over the duration of the study (14+ weeks). the immersive vr component of the study involves a virtual experience of navigating a challenging workplace scenario to understand stress response and provide an overview of interventions that can be used to reduce workplace stress. upon completion of the in-person vr visit, participants will continue to use the app and the wearable for the study duration to understand stress responses in their actual workplaces. participants will have real-time access to their essential data on wellness collected through the app and wearable (e.g., sleep, activity, physiological signals, anxiety symptoms). the digital intervention suite (combined use of these three components: vr, app, and wearable) is essential for a thorough understanding of stress and moral distress. this is a de-identified study, and the team will only have access to de-identified data for analysis at the end of the study.

Eligibility criteria:
inclusion criteria: 1. registered nurses (rns) or registered practical nurses (rpns) who are currently employed at a healthcare institution in ontario. 2. ownership of a smartphone. exclusion criteria: 1. history of seizures (except febrile seizure). 2. use of electronic medical devices (e.g., cardiac pacemakers, hearing aids, and defibrillators). 3. a score of ≥ 15 on the generalized anxiety disorder (gad-7) scale 4. a score of ≥ 20 on the patient health questionnaire (phq-9).

Keywords: moral distress stress virtual reality wearables web-based intervention nursing professionals nursing staff distress covid-19
study to evaluate d-1553 in subjects with lung cancer

Conditions: NSCLC

Summary: this is a phase 1/2, open label study of d-1553 single agent treatment to assess the safety and tolerability, identify the mtd and rp2d, evaluate the pk properties and antitumor activities in subjects with advanced or metastatic nsclc with krasg12c mutation


Eligibility criteria:
inclusion criteria: * subject with histologically proven, locally advanced, unresectable and/or metastatic nsclc for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment. * subject has krasg12c mutation in tumor tissue or other biospecimens containing cancer cells or dna. historical, local laboratory result (up to 5 years prior to this study) can be used for phase 1 subjects. phase 2 subjects must be tested for krasg12c mutation by a central laboratory. * subject has measurable disease according to recist, v1.1 exclusion criteria: * subject with unstable or progressive central nervous system (cns) metastases. * subjects with clinically significant cardiovascular disease * subject with interstitial lung disease (ild) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. * subject has impaired gastrointestinal (gi) function or gi diseases that may significantly alter the absorption or metabolism of oral medications. * subject is pregnant or lactating.
improvement of epo-resistance in hemodialysis patients with chronic inflammation by high cut-off hemodialysis

Conditions: End-Stage Renal Disease (ESRD)

Summary: chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (esas). this study aims to demonstrate that high cut-off hemodialysis is effective in reducing chronic inflammation and thereby improving response to esas.

chronic inflammation in hemodialysis patients (micro-inflammation) is caused by multiple inflammatory stimuli and becomes apparent by elevated levels of biochemical markers such as crp, il-6, cellular activation markers etc. chronic inflammation is linked to clinical signs and symptoms and cardiovascular mortality in dialysis patients. inflamed dialysis patients show impaired response to erythropoiesis-stimulating agents (esa) related to reduced iron utilization (functional iron deficiency) and elevated crp levels are associated with a greater need for esa to meet hemoglobin targets. if absolute iron deficiency can been excluded, epo resistance is likely related to 'inflammatory block'. the high molecular permeability of the theralite high cut-off membrane allows for significant clearance of cytokines and other pro-inflammatory solutes by hemodialysis as shown in previous trials with high cut-off dialyzers. the study therefore aims to demonstrate that theralite dialysis is effective in reducing chronic inflammation in esrd patients, thereby improving epo responsiveness. if this can be demonstrated, application of theralite hemodialysis may reduce morbidity and mortality in the long term in esrd patients.

Eligibility criteria:
inclusion criteria: * esrd treated with chronic hd for at least 3 months * treatment with high-flux dialyzers for at least 3 months * age ≥18 years * receiving esa to treat anemia for at least 3 months * impaired esa responsiveness as indicated by epo resistance index \> median of patients in study center * transferrin saturation (tsat) ≥20% (last routine value prior to randomization) * serum ferritin ≥100 ng/ml (last routine value prior to randomization) exclusion criteria: * acute infection ≤4 weeks prior to randomization * hiv or hepatitis infection * catheter * chronic liver disease * active cancer * known blood dyscrasia (paraprotein abnormalities) * known bleeding disorders * bleeding episode ≤12 weeks prior to randomization * blood/red cell transfusion ≤12 weeks prior to randomization * hypoalbuminemia defined as serum albumin concentration below 35 g/l (last routine value prior to randomization) * participation in another clinical interventional investigation * pregnancy * inability to give informed consent * planned transplantation within study period +3 months * planned interventions requiring hospitalization \>1 week

Keywords: end-stage renal disease (esrd) chronic inflammation epo resistance esa resistance high cut-off dialysis hemodialysis
reappraisal of atrial fibrillation: interaction between hypercoagulability, electrical remodeling, and vascular destabilisation in the progression of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to study clinical factors and (blood) biomarkers related to progression of atrial fibrillation (af) in patients diagnosed with self-terminating af with special reference to hypercoagulability. all patients will be continuously monitored for their atrial rhythm to assess af progression, either through an implantable loop recorder (reveal linq) or via the atrial lead of a cardiac implantable electronic device (cied), both in combination with the carelink home monitoring system. remote monitoring and interrogation will be installed and used on a daily basis.


Eligibility criteria:
inclusion criteria: * new onset or history of paroxysmal, self-terminating af documented as: * af on ecg or holter-recording or loop recorder * subclinical af detected in implantable cardiac devices (atrial read \> 190 beats per minute, lasting \> 6 minutes). * prior history of self-terminating af is allowed; * able and willing to sign informed consent for the registry; * able and willing to undergo implantation of an implantable loop recorder (in patients without a cied); * in patients already on oral anticoagulation drugs, the following inclusion criteria need to be met (to allow for safe temporary interruption of anti-thrombotic treatment for coagulation phenotyping): * cha2ds2-vasc score ≤5 (history of congestive heart failure, hypertension, age ≥ 75 years (doubled), diabetes mellitus,stroke/transient ischemic attack (doubled), vascular disease, age 65-75 years, female sex); * no other indication for oral anticoagulation (e.g. mechanical valve prosthesis); * patient is willing to temporarily stop oral anticoagulation drugs (oac). exclusion criteria: * non-self-terminating, persistent af; * deemed unsuitable or not willing to undergo implantation of loop recorder (in patients without a cied); * refusing to temporarily stop oac for coagulation phenotyping (in patients already on oac before inclusion in this study); * on waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year; * expected to start with amiodarone; * pregnancy; * life expectancy of less than 2.5 years.
heart rate control with esmolol in septic shock

Conditions: Septic Shock

Summary: the purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock.

154 septic shock patients with heart rate \> of 95 bpm and requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmhg despite adequate volume resuscitation, will be enrolled in the study. patients will be randomly allocated to be treated with either a) a continuous esmolol infusion at any doses to maintain heart rate between 95 and 80 bpm b)to a standard treatment without heart rate control(control; each n = 77). in both groups, norepinephrine will be titrated to achieve a mean arterial pressure (map) between 65 and 75 mmhg. data from right heart catheterization,data from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72, and 96 hours. the protocol will require that esmolol be infused continuously at any doses to maintain the predefined heart rate threshold until one the following events occur: the patient die, a serious adverse effect attributed to the study drug infusion, or the patient has been discharged from icu.

Eligibility criteria:
inclusion criteria: * septic shock criteria * presence of heart rate \> 95 bpm. exclusion criteria: * pregnancy * age \< 18

Keywords: septic shock esmolol tachycardia betablockers