Kornimate/medical-research-clean huggingface dataset:
a study of ixekizumab (ly2439821) compared to guselkumab in participants with moderate-to-severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to compare the efficacy and safety of ixekizumab to guselkumab in participants with moderate-to-severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * have chronic plaque psoriasis based on a diagnosis for at least 6 months before baseline as determined by the investigator. * are a candidate for phototherapy and/or systemic therapy. * have both an static physician global assessment (spga) score of ≥3 and a psoriasis area and severity index (pasi) score ≥12 at screening and at baseline. * have ≥10% body surface area (bsa) involvement at screening and baseline. * if a male, agree to use a reliable method of birth control during the study. * if female, agree to use highly effective method of contraception. exclusion criteria: * predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis. * have a history of drug-induced psoriasis. * had a clinically significant flare of psoriasis during the 12 weeks before baseline. * use of tanning booths for at least 4 weeks before baseline. * concurrent or recent use of any biologic agent within the following periods prior to baseline: etanercept \<28 days; infliximab, adalimumab, certolizumab pegol, or alefacept \<60 days; golimumab \<90 days; rituximab \<12 months; secukinumab \<5 months; or any other biologic agent (e.g., ustekinumab) \<5 half lives. * have prior use of il-23p19 antagonists (e.g., guselkumab, tildrakizumab, risankizumab), or have any condition or contraindication as addressed in the local labeling for guselkumab that would preclude the participant from participating in this protocol. * have previously completed or withdrawn from this study, participated in any other study with ixekizumab or guselkumab, have participated in any study investigating il-23p19 antagonists, or have received treatment with ixekizumab. * have previously failed to respond to an il-17 antagonist, per investigator assessment. * have had a live vaccination within 12 weeks of baseline. * have a known allergy or hypersensitivity to any biologic therapy. * have had any major surgery within 8 weeks of baseline. * have had a serious infection, have been hospitalized, or have received intravenous antibiotics for an infection within 12 weeks of baseline. * are women who are pregnant, or who are lactating (breast-feeding).

Keywords: biologic biologic therapy
pre-emptive scalp infiltration with dexamethasone plus ropivacaine for post-craniotomy pain in children

Conditions: Pain, Postoperative; Children

Summary: at present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. on the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. for the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. however, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. as is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. researchers have clarified that the addition of dexamethasone to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. to date, no studies have evaluated the addition of dexamethasone to local infiltration for patients receiving craniotomy. thus, investigators suppose that pre-emptive scalp infiltration with steroid (dexamethasone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.


Eligibility criteria:
inclusion criteria: * an elective craniotomy under general anesthesia; * american society of anesthesiologists (asa) physical status of i or ii; * participates with an anticipated fully recovery within 2 hours postoperatively; * informed consent by parent(s) and/or legal guardian. exclusion criteria: * history of allergies to any of the study drugs; * drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids; * psychiatric disorders; * uncontrolled epilepsy; * chronic headache; * peri-incisional infection; * body mass index exceeded the 99th percentile for age; * children who must use a patient-controlled analgesia (pca) device; * children who cannot understand an instruction of pain scales before surgery.
evaluation of functional outcomes after laparoscopic promontofixation (pfl).

Conditions: Pelvic Organ Prolapse; Symptoms; Satisfaction; Quality of Life

Summary: prolapse of the pelvic organs is a common pathology in women with a strong impact on the quality of life. its prevalence tends to increase due to increased life expectancy and obesity. the main treatment is surgical and involves all organ specialists dealing with pelvic-perineal functional disorders: urologists, gynecologists, digestive surgeons. our team wishes to evaluate, on a cohort of patients operated at the caen university hospital, the functional uro-gynecologic, digestive and sexual results of pelvic organ prolapse (pop) repair by laparoscopic promontofixation (pfl) through symptoms and quality of life validated questionnaires (qol). the analysis of the responses to these questionnaires will allow us to evaluate the functional results in the short and medium term (from 6 months to 5 years)

this is a retrospective cohort study conducted at the universitary hospital of caen in three surgical departments (gynecology, urology and digestive surgery). patients who had a laparoscopic promontofixation will be asked to respond to validated questionnaires of symptoms and quality of life after their surgery (pfdi-20, iciq-sf, pfiq-7) and satisfaction (pgi-i)

Eligibility criteria:
inclusion criteria: patients who have had a laparoscopic promotofixation for genital prolapse at the university hospital of caen between 2013 and 2018 in the departments of gynecology, urology and digestive surgery. patient who received written information and agreed to participate in the study exclusion criteria: minor patient, under guardianship, under trusteeship patient not understanding french refusal to participate in the study

Keywords: pelvic organ prolapse laparoscopic promontofixation symptoms satisfaction quality of life
effectiveness of wbv versus ras on spasticity, balance, and lower limb motor function on hemiplegic stroke patients

Conditions: Stroke

Summary: this study investigates the effectiveness of whole-body vibration (wbv) versus rhythmic auditory stimulation (ras) on spasticity, balance, and lower limb motor function in hemiplegic stroke patients. the objective was to compare the two interventions to determine which provides greater benefits in stroke rehabilitation. hemiplegic stroke patients were randomly assigned to either the wbv group, receiving whole-body vibration therapy, or the ras group, undergoing rhythmic auditory stimulation sessions.

the study measured spasticity using the modified ashworth scale (mas), balance with the berg balance scale (bbs), and lower limb motor function through the fugl-meyer assessment (fma). results indicated that both wbv and ras significantly improved spasticity, balance, and lower limb motor function.

Eligibility criteria:
inclusion criteria: * participant with age from 40 to 60 years * both males and females * diagnosed cva patients * chronic stage (after 6 months of onset * individuals with bbs score ≥ 20 ≤ 40 * fmi score up to 3(moderate assistance) * able to understand command * mini-mental state examination (mmse) score of over 20 exclusion criteria: * systematic disorder e.g. rheumatoid arthritis * unstable angina * coexisting physical impairments e.g. limb amputation * any previous history of neurological disease other than stroke e.g. parkinson's * any previous history of fractures * hearing or perception deficits * individuals unable to adhere to the study protocol or attend scheduled follow-up visits.
comparison between one-stage hybrid ablation and thoracoscopic surgical ablation for intractable atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (af) were unsatisfied. recently, hybrid ablation therapy for af had encouraging outcomes. however, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. this study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent af with enlarged left atrium.

this study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent af with enlarged left atrium.

Eligibility criteria:
inclusion criteria: * patients with at least one anti-arrhythmic drugs * persistent af lasting more than 1 year or with a left atrial diameter\>50mm exclusion criteria: * previous percutaneous catheter ablation or surgical ablation * presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease) * left atrial diameter\>60mm * previous thoracic or lung operation * left atrial thrombosis or left atrial appendage thrombosis * chronic obstructive pulmonary disease (copd) (forced expiratory volume in 1 second (fev1)/forced vital capacity (fvc)\<70%、fev1\<50% anticipated value) * bilateral carotid artery stenosis\>80% * refuse to participate in this study

Keywords: hybrid ablation thoracoscope
standardization of a novel self-administered tablet computer-based clinical screening tool for adverse postoperative cognitive outcomes

Conditions: Delirium

Summary: postoperative delirium (pod) and postoperative cognitive dysfunction (pocd) are common complications after surgery and may affect elderly patients in particular. cogcheck, an application for tablet computers, was developed with the intention to assist preoperative risk screening for pod and pocd in surgical patients. the aim of this study is to generate normative data with cognitively healthy participants for the application.

postoperative delirium (pod) and postoperative cognitive dysfunction (pocd) are common complications after surgery and may affect elderly patients in particular. prior studies found risk factors for pod and pocd which are present preoperatively, e.g. older age and pre-existing cognitive impairment. however, the preoperative risk of postoperative adverse cognitive outcomes (pod and pocd) is often not screened in routine clinical practice as it is time-consuming and requires trained personnel. in 2014, the application for tablet computers "delirium risk profile" (drp) was developed at the university hospital basel to assist preoperative screening in surgical patients. the application was later renamed cogcheck as the scope of the tool was extended to pod and pocd risk assessment. the aim of this study is to provide normative data for the application. ultimately, the objective is to assist health care providers in the evaluation of patients' cognitive functions by routinely using the application in preoperative clinics.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * education ≥ 7 years * fluency in the german language * written informed consent exclusion criteria: * history of cognitive impairment * signs of depression * severe sensory or motor impairment interfering with cognitive testing * serious somatic disease, disease or event affecting the central nervous system (head trauma with loss of consciousness \> 5 minutes, any brain surgery, general anesthesia within the last 3 months, alcoholism, intoxication with neurotoxic substances) * cerebrovascular disease * regular medication with psychoactive drugs except for benzodiazepines * participation in any cognitive study within the last 3 months or previous participation in a study using the application.

Keywords: postoperative delirium risk assessment clinical screening tool tablet computer
breast cancer prevention education

Conditions: Breast Cancer Prevention

Summary: we will develop and evaluate a community-based approach for disseminating comparative effective reviews (cers) about breast cancer prevention to african american women. the specific aims of our research, as shown below, will target this population because of persistent disparities in breast cancer morbidity and mortality among this population. our primary aims are: 1. to evaluate uptake of a community-based strategy for disseminating cers about breast cancer prevention to african american women based on sociodemographic characteristics, beliefs about medical research, and medical history. we predict that participation in a community forum will be higher among women with greater socioeconomic resources, those who have a family history of breast cancer, and women who have more positive beliefs about research. 2. to evaluate the impact of evidential versus non-evidential content about breast cancer prevention on psychological and behavioral outcomes that include: knowledge of breast cancer risk factors and prevention strategies, communication with individuals in their social and medical network, and distrust of medical research. we predict that women who receive evidential content that is specific for african american women will report greater knowledge about breast cancer risk factors and prevention strategies, will be more likely to discuss breast cancer prevention strategies with individuals in their social and medical network, and will report greater reductions in distrust of medical research compared to those who receive non-evidential content.


Eligibility criteria:
inclusion criteria: * african american women * ages 35-70 * no personal history of cancer * resident of philadelphia metropolitan area exclusion criteria: * non-african american * male * under 35 or over 70 years of age * personal history of cancer * not a resident of philadelphia metropolitan area

Keywords: breast cancer breast cancer prevention african american women
the impact of metabolic syndrome on patients undergoing elective laparotomy

Conditions: Metabolic Syndrome; Anesthesia; Perioperative Outcome; Complications

Summary: worldwide, the rising incidence of obesity has led to the identification of an obesity related syndrome, called metabolic. this syndrome is characterized by central obesity, hypertension, insulin resistance and altered lipid levels. taking into consideration the rising incidence of obesity, anesthetists will more frequently encounter patients with metabolic syndrome, in their everyday practice. moreover, the comorbidities that are related to the metabolic syndrome, increase the risk for perioperative complications. therefore, strategies that will evaluate and modify the risk will be of great importance in the management of these patients, in order to maximize peri-anaesthetic and surgical safety. the aim of the study is to assess the incidence of metabolic syndrome and the impact of its presence on the outcome of patients undergoing elective laparotomy.


Eligibility criteria:
inclusion criteria: * adult patients are undergoing elective laparotomy of estimated duration of more than one hour. all operations will be performed under general anesthesia. exclusion criteria: * endstage neoplasia * procedures performed within 1 hour of admission * emergency cases
prospective follow-up of elderly patients undergoing instrumented lumbar arthrodesis supplemented by the implanet jazz system(tm)

Conditions: Spondylolisthesis; Spinal Stenosis; Degenerative Disease

Summary: establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the implanet jazz system.

to collect and organize data into a repository from the principal investigator's and other site investigators' elderly patients (aged ≥ 60 years) who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the implanet jazz systemtm at participating centers. this device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from t1 to l5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. of note, these patients will receive the supplemental support of the implanet jazz sublaminar band as their clinical standard of care deems necessary and separately from study participation. clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

Eligibility criteria:
inclusion criteria: * patients who are candidates for single, two- or three-level spinal arthrodesis surgery supplemented by the implanet jazz system * patients at least 60 years of age. exclusion criteria: * patients under the age of 60 years old are excluded.
development and validation of a health-related quality of life tool for patients with cardiac sarcoidosis

Conditions: Cardiac Sarcoidosis

Summary: what is the purpose of this research? this study includes two parts based in two nhs specialist centres for cardiac sarcoidosis: * development of the card-sarc: development of the new questionnaire to measure quality of life in cardiac sarcoidosis patients (the card-sarc questionnaire) * validation of the card-sarc: evaluation of how good the card-sarc questionnaire is at measuring quality of life changes in patients with cardiac sarcoidosis.

what would taking part involve? first, we would like to talk with a group of patients (between 6 to 20) about the impact of cardiac sarcoidosis in their quality of life during an interview. we will review and analysed these interviews. then, we will compare with what is already know about cardiac sarcoidosis and its impact on quality of life. also, we will ask healthcare professionals working with cardiac sarcoidosis patients to review our results. finally, we will use this information to create the first draft of the new questionnaire (card-sarc questionnaire)to measure quality of life in cardiac sarcoidosis patients. second, we will ask 20 patients with cardiac sarcoidosis to complete the draft version of the card-sarc questionnaire. also, they will complete validated quality of life questionnaires (for general population or sarcoidosis patients) and questionnaires that explore potential symptoms of fatigue, anxiety and depression. we will compare an review these results to confirm that the card-sarc questionnaire is ready for evaluation. third, we will ask 100 cardiac sarcoidosis patients to complete the card-sarc questionnaire and the validated questionnaires (for quality of life and potential sarcoidosis symptoms) to evaluate how good the card-sarc is at measuring quality of life changes in cardiac sarcoidosis patients. how will patients or the public help guide the research? this work has been influenced and designed with people living with cardiac sarcoidosis. sarcoidosisuk, the uk sarcoidosis charity, has been supportive and engaged on this work. likewise, five expert patients with cardiac sarcoidosis have also agreed to lead, contribute and advice on relevant aspects of the study, and to participate sharing the results to the public, patients and professional groups.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) * patients with a probable (50-90% likelihood) or highly probable (\>90% likelihood) diagnosis of cardiac sarcoidosis (cs) by a multidisciplinary team meeting in a cs-specialist centre as per the wasog criteria * patients attending outpatient clinics in a cs-specialist centre exclusion criteria: * unable or unwilling to give informed consent * unable or unwilling to give and/or complete the study questionnaires • inability to understand written and/or verbal english

Keywords: cardiac sarcoidosis health-related quality of life
effect of mannitol on postreperfusion syndrome during living donor liver transplant

Conditions: Liver Transplant Disorder

Summary: postreperfusion syndrome during living liver transplants remains a serious concern for transplant anesthesiologists. this syndrome is responsible for decreases in systemic blood pressure, systemic vascular resistance, and cardiac output and can even lead to cardiac arrest. delayed graft function and primary graft nonfunction are closely related to postreperfusion syndrome (therefore, attenuating the syndrome during anesthesia is of great importance.


Eligibility criteria:
inclusion criteria: * patients with end-stage liver disease who will undergo living donor transplantation. exclusion criteria: * patients with a history of portopulmonary hypertension. * hepatopulmonary syndrome. * cirrhotic cardiomyopathy. * hepatorenal syndrome types 1 and 2.
intravenous colistin versus intravenous colistin plus nebulized colistin in vap due mdr acinetobacter baumannii

Conditions: Cross Infection; Pneumonia, Bacterial

Summary: compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with vap due to baumannii carbapenems resistant.

compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with vap due to baumannii carbapenems resistant.

Eligibility criteria:
inclusion criteria: * diagnose of vap due a. baumannii or a. baumannii and another microorganism carbapenems resistant. * clinical pulmonary infection score (cpis) \> 6 exclusion criteria: * allergy to colistin. * asthma * shock status * diagnose of vap due a. baumannii colistin resistant.

Keywords: acinetobacter baumanii ventilator-associated pneumonia