Kornimate/medical-research-clean huggingface dataset:
study evaluating preference, satisfaction and ease of use of inhalers in chronic obstructive pulmonary disease (copd) diagnosed patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: preference study: genuair vs handihaler inhalers in copd patients.


Eligibility criteria:
inclusion criteria: * adult male or female patients aged ≥ 40 with stable copd * naïve patients to the use of study inhalers * patients agreeing on participating and signing the informed consent form exclusion criteria: * patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system * patients unable to read product package instructions and answer patient reported questionnaires
executive functioning and sleep fragmentation in covid-19 patients

Conditions: COVID-19; Healthy Volunteers

Summary: this project aims to investigate executive functioning abilities (primary outcome) and quality of sleep (secondary outcome) in patients with covid-19 (while distinguishing between those with and without sleep fragmentation), compared with an age- and education matched control group of healthy individuals who did not experience contagion. prefrontal electrical activity will be recorded with eeg in patients, and related to sleep and cognitive-executive metrics. the main questions it aims to answer are: * is executive functioning impaired in covid-19 patients compared with individuals who were not infected? * is there a relationship between altered sleep and impaired executive functioning in covid-19 patients? * is such relationship related to altered prefrontal brain activitity in covid-19 patients?

while impaired executive functioning has been often reported in association with covid-19 contagion, it is still unclear whether, and to what extent, executive deficits might be explained by an altered quality of sleep, that been also frequently reported in covid-19 patients. on this basis, this project aims to investigate executive functioning abilities (primary outcome) in patients hospitalized for a covid-19 contagion, while distinguishing between those with and without sleep fragmentation (quality of sleep; secondary outcome), compared with an age- and education matched control group of healthy individuals who did not experience contagion. to this purpose, 38 covid-19 patients and 38 healthy controls will be administered questionnaires and cognitive tasks aimed to assess: a) executive functioning/inhibitory control (gonogo task); b) quality of sleep (nosas; insomnia severity index; epworth sleepiness scale). prefrontal electrical activity will be recorded with eeg in covid-19 patients, and related to sleep and cognitive-executive metrics. statistical analyses will be aimed to investigate: a) a possible decrease of executive skills in covid-19 patients compared with healthy controls, and in covid-19 patients with fragmented sleep compared with those with normal sleep; b) possible differences in the relationship between executive performance and quality of sleep across the three experimental groups; c) whether possible differences in such relationship relate to prefrontal brain activity in patients. the results of this study will provide novel insights into the consequences of covid-19 at the cognitive level, thus informing about treatment strategies.

Eligibility criteria:
inclusion criteria: * for patients: current contagion from covid-19 * for patients and controls: * age\>18 years * absence of clinical conditions, cognitive and sensory deficits, and severe psychiatric disorders that would impair participation in research identified through clinical history. exclusion criteria: * current or past neuro-psychiatric disorder * current or past sleep disorder

Keywords: covid-19;executive functioning;quality of sleep
a study of mavrilimumab versus anti tumor necrosis factor in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (ra) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (dmards) and/or one or two anti-tumor necrosis factor (tnf) agents (excluding golimumab) for efficacy or safety reasons.

despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (ra), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. the aim of the current study is to compare the efficacy and safety of a subcutaneous dose of mavrilimumab with a marketed treatment for ra (golimumab) in 120 adult subjects with moderate-to-severe active ra who have had an inadequate response to one or two anti-tnf agents with mavrilimumab. the design of the study was exploratory and not formerly statistically powered.

Eligibility criteria:
inclusion criteria: * age 18 through 80 years * written consent * diagnosis of adult onset rheumatoid arthritis (ra) as defined by the 2010 american college of rheumatology european league against rheumatism (acr/eular) classification criteria * moderately active disease as defined by disease activity score in 28 joints c-reactive protein (das28\[crp\]) greater than or equal to (\>=) 3.2 at screening and das28 erythrocyte sedimentation rate(esr) ≥ 3.2 at day 1 * inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (dmards) * at least 4 swollen joints * inadequate response to one or two anti-tnf agents other than the study comparator, as defined by the protocol * receiving oral or injectable methotrexate, as defined by the protocol. exclusion criteria: * a rheumatic autoimmune disease or other inflammatory joint disease other than ra * previous treatment with biologic therapies other than anti-tnf for ra * treatment with other dmards or non-steroidal anti-inflammatory drugs (nsaids), as defined by the protocol. * medical history as defined by the protocol.

Keywords: rheumatoid arthritis golimumab mavrilimumab
study of neutrophils and circulating platelets in correlation with the activity of t lymphocytes in patients with nafld (nonalcoholic fatty liver disease)

Conditions: NAFLD- Non Alcoholic Fatty Liver Disease

Summary: the aim of the study is to define the relationship between neutrophils, platelets and the activity of t lymphocytes in patients with nafld (nonalcoholic fatty liver disease). this study may predict, in the course of hepatic steatosis, specific phenotypic patterns expressed by pmns and circulating platelets to evaluate their role in disease progression.


Eligibility criteria:
inclusion criteria: * patients over 18 * no alcoholic abuse * hepatic steatosis diagnosticated by abdominal ultrasound * negative hepatitis b and c tests * no history of hepatic cirrhosis exclusion criteria: * under 18 * history of alcoholic abuse * positive serology for hepatitis b or c * history of hepatic cirrhosis
a study to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis who are less than 24 months of age at treatment initiation and have an approved ivacaftor-responsive mutation

Conditions: Cystic Fibrosis

Summary: this is a phase 3, 2-arm, multicenter study with an open-label ivacaftor arm and an observational arm to evaluate the safety and efficacy of long-term ivacaftor treatment in participants with cystic fibrosis (cf) who are \<24 months of age at treatment initiation and have an approved ivacaftor-responsive mutation.


Eligibility criteria:
inclusion criteria: ivacaftor arm: participants from study 124 (nct02725567 ) part b: * participants transitioning from study 124 part b must have completed the last study visit of study 124 part b. * as judged by the investigator, parent or legal guardian must be able to understand protocol requirements, restrictions, and instructions; and must sign the informed consent form (icf). ivacaftor arm: participants not from study 124 part b: * confirmed diagnosis of cf, or 2 cf-causing mutations. * an ivacaftor- responsive cftr mutation on at least 1 allele. participants will be eligible in countries/regions where ivacaftor is approved for use in participants 2 years of age and older. * as judged by the investigator, parent or legal guardian must be able to understand protocol requirements, restrictions, and instructions; and must sign the icf. observational arm: * received ivacaftor treatment in study 124 part b and elected not to enroll or ineligible to enroll in the ivacaftor arm of study 126. exclusion criteria: ivacaftor arm: participants from study 124 part b: * history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering ivacaftor to the participant. * participants receiving commercially available ivacaftor treatment ivacaftor arm: participants not from study 124 part b: * history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering ivacaftor to the participant * an acute upper or lower respiratory infection, or pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of day 1 * abnormal liver function at screening * hemoglobin \<9.5 g/dl at screening * history of solid organ or hematological transplantation * use of any moderate or strong inducers or inhibitors of cyp3a within 2 weeks of day 1 observational arm: * receiving ivacaftor treatment other protocol defined inclusion/exclusion criteria may apply.
molecular network characteristics of phlegm-heat syndrome in ischemic stroke based on multi-omics integrated analysis

Conditions: Ischemic Stroke, Acute

Summary: the molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. the main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.

this is a cohort study in patients with ischemic stroke. the demographic characteristics, tcm syndromes, and other baseline information will be recorded. at the same time, baseline peripheral blood will be collected. these participants will be followed up to 90 days of onset, and 90-day modified rankin scale (mrs) scores will be assessed. the collected blood samples will be tested by multi-factor detection technology for candidate biomarkers.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke, were confirmed by magnetic resonance imaging (mri). * symptom onset within 72 hours. * diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome. * male or female ≥ 50 years and ≤ 80 years. * with written informed consent. exclusion criteria: * planned or already receiving intravenous thrombolysis or endovascular treatment. * acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment. * patients with previous stroke. * renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases. * other conditions that may affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).
efficacy and safety of nyx-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy (dpn)

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: to evaluate the efficacy of nyx-2925 versus placebo in treating the neuropathic pain associated with diabetic peripheral neuropathy.

this is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of nyx-2925 in subjects with neuropathic pain associated with diabetic peripheral neuropathy. the study will be a 13- to 16-week study, including a 1- to 4-week screening period, followed by a 12- week double-blind, randomized, placebo-controlled treatment period.

Eligibility criteria:
inclusion criteria: * informed consent * subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities for ≥4 years and reports at least moderate pain over the last week * stable diabetic and protocol allowed medication during the study * agrees to use highly effective birth control during the study * has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study exclusion criteria: * pain due to other conditions or diseases that would complicate participation in the study or pain reporting * current or historical serious medical conditions * prior participation in nyx-2925 clinical trial
a multicenter trial comparing induction c/t followed by ccrt v.s. ccrt alone in stage iv nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: investigate the effect of induction mepfl chemotherapy followed by concurrent chemoradiotherapy (ccrt) on the disease control and survival in treatment of patients with advanced npc.

rationale of induction chemotherapy: distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced npc. concurrent chemoradiotherapy may prolong survivals for patients with advanced npc, but it is still flawed by high incidence of distant metastasis. induction chemotherapy with mepfl has been shown to reduce the incidence of distant metastasis in a phase ii study. induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced npc. objectives: investigate the effect of induction mepfl chemotherapy followed by concurrent chemoradiotherapy (ccrt) on the disease control and survival in treatment of patients with advanced npc. study design: this is a randomized, multi-center phase iii study. patients will be randomized to ccrt with or without the mepfl induction chemotherapy. type and number of patients: patients with stage iva (t4) and/or ivb (n3) but without distant metastasis will be enrolled. a total of up to 480 patients will be randomized to detect an improvement of median overall survival from 5.8 to 8.7 years, with an a=0.05 and power of 0.8 using a two-sided logrank test with one interim analysis. treatment schedule: induction chemotherapy and ccrt: arm a: weekly cisplatin concurrently with radiotherapy arm b: induction mepfl three cycles followed with weekly cisplatin concurrently with radiotherapy. study endpoints: the primary endpoint is the disease-free survival that will be calculated as the duration between the date of randomization and the date of recurrence of npc at any site including persistent disease after +induction chemotherapy/ccrt, or death from any cause (failed), or the date of withdrawal (last contact date, censored), or the scheduled data analysis date (censored).( revised 8/27/2004)

Eligibility criteria:
inclusion criteria: * histologically proved nasopharyngeal carcinoma. * t4nxm0 or txn3m0 disease by uicc/ajcc 1997 staging system. (30) * eastern cooperative oncology group performance status \< 2. * a leukocyte count ≥3750/ml, hb ≥ 10 g/dl, and a platelet count ≥100,000/ml. * a serum bilirubin level \ 60 ml/min. * age less than 70 years old * an informed consent signed. exclusion criteria: * evidence of metastatic disease. * presence of another malignancy other than treated squamous/basal cell carcinoma of the skin. * presence of uncontrolled hypertension, poorly controlled heart failure. * presence of active infection. * patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies. * women who test positive for pregnancy.

Keywords: a multicenter phase iii trial induction chemotherapy concurrent chemoradiotherapy stage iv nasopharyngeal carcinoma (npc) randomization disease-free survival
an acceptance-based behavioral intervention vs. nutritional counselling for weight loss in psychotic illness

Conditions: Psychotic Illnesses

Summary: obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. the risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. this pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. this is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. the results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time. primary hypothesis: weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.


Eligibility criteria:
inclusion criteria: * bmi \> 25.0 * diagnosed psychotic illness (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar i disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, and psychotic disorder not otherwise specified). exclusion criteria: * inability to provide informed consent * prediabetes or type 2 diabetes mellitus * current enrollment in another formal weight management program * brief psychiatric rating scale (bprs) ratings of 4 or more on any one of grandiosity (item #6), suspiciousness (item #7), hallucinations (item #8), unusual thought content (item #9), or conceptual disorganization (item #10), or a bprs total score of 80 or more.
study evaluating venlafaxine er in adults with panic disorder

Conditions: Panic Disorder

Summary: the primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (er) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (pd) in a placebo-controlled phase iii study.


Eligibility criteria:
inclusion criteria: * a male or female outpatient * be at least 18 years of age and legal age of consent * meet dsm-iv criteria for pd (with or without agoraphobia) for at least 3 months before study day 1 exclusion criteria: * treatment with venlafaxine (ir or er) within 6 months of study day 1 * known hypersensitivity to venlafaxine (ir or er) or related compounds * history or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma \[except basal cell epithelioma\], uncontrolled hypertension)

Keywords: panic disorder
vgh-desjs-1 in ocular and oral dryness symptoms of dry eye syndrome and sjögren's syndrome

Conditions: Dry Eye Syndrome; Sjogren's Syndrome; Xerophthalmia

Summary: to evaluate the chinese herbal tea vgh-desjs-1 in ocular and oral dryness symptoms of dry eye syndrome and sjögren's syndrome

method: this study wants to evaluate the chinese herbal tea vgh-desjs-1 on nourishing yin and moistening dryness the ocular dryness from dry eye syndrome (des) and sjögren's syndrome (sjs). one hundred dry eye subjects are composed of 30 dry eye syndrome subjects, 60 sjögren's syndrome' dry eye subjects, and 10 non des sjs healthy controls, nhc). des, sjs, and nhc received vgh-desjs-1 daily during 8 weeks for the evaluation before and after the subjects receiving the vgh-desjs-1. moreover, we could use the whole-genome genotyping, schirmer's test, tear breakup time (tbut), cytokines, ocular surface disease index (osdi), eular sjogren's syndrome patient reported index (esspri), pittsburgh sleep quality index (psqi), ford insomnia response to stress test (first), traditional chinese medicine (tcm) pattern, tcm tongue diagnosis, tcm pulse diagnosis, and tcm heart rate variability, and it could be applied for the goal of holistic health care. expected results: 1. to evaluate the difference among schirmer's test, tbut, tcm pattern, tcm tongue diagnosis, tcm pulse diagnosis, heart rate variability, whole-genome genotyping, and cytokines for des, sjs, and nhc. 2. to evaluate the nourishing yin and moistening dryness of vgh-desjs-1 for des and sjs. 3. to evaluate the nourishing yin and moistening dryness of vgh-desjs-1 for des. 4. to evaluate the nourishing yin and moistening dryness of vgh-desjs-1 for sjs. keywords: dry eye syndrome, sjögren's syndrome, xerophthalmia, chinese herbal tea, nourishing yin and moistening dryness

Eligibility criteria:
dry eye syndrome -inclusion criteria: aged between 20 and 75 years schirmer's test less than 10 mm/5 min -exclusion criteria: pregnancy with eye inflammation or infectious eye disease accepted operation of eye sjögren's syndrome -inclusion criteria: primary or secondary ss aged between 20 and 75 years fulfilled the 2002 american-european consensus criteria for ss (aecg) had no abnormal findings of immune, liver, kidney, or blood function evaluations. -exclusion criteria: a history of alcohol abuse, diabetes mellitus, or major life-threatening condition pregnancy or breastfeeding steroid pulse therapy within three months prior to the commencement of our study. non aiddes healthy controls -inclusion criteria: aged between 20 and 75 years without any chronic disease -exclusion criteria: any sjögren's syndrome or dry eye syndrome.

Keywords: dry eye syndrome sjogren's syndrome xerophthalmia chinese herbal tea nourishing yin and moistening dryness
mapping covid-19 spread in a tertiary hospital

Conditions: Covid19; Spatial Visualization; Neural Network; Respiratory Disease; Pandemic; Disease Spread

Summary: one of the major problems in suppressing the spreading of an epidemic resides in understanding and monitoring its propagation patterns, and in evaluating how these are modified by enforced policies. the standard solution requires detailed information at the microscopic scales, e.g. how infected people have moved and whom they came in contact with, which is hardly ever available. the researchers propose a novel approach to the study of the propagation of covid-19, in which a proxy of this information is derived at macroscopic scales. this will be based on two ingredients: the spatiotemporal study in shiny with mathematical models with aggregated or non aggregated data and the reconstruction of functional networks of spreading patterns, and the development of a supporting software.


Eligibility criteria:
inclusion criteria: * positive test (pcr or serology) for sars-cov-2 * outpatient follow-up exclusion criteria: * hospitalisation in ward or icu