Kornimate/medical-research-clean huggingface dataset:
fingolimod effect on cytokine and chemokine levels

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the main purpose of this study was to measure the serum levels of cytokines and chemokines that are known to increase during multiple sclerosis relapses. cytokines are a broad and loose category of small proteins that are important in cell signaling. the second purpose of the study was to test the cytokine/chemokine changes measured in the 3rd and 6th months on the efficacy parameters.


Eligibility criteria:
key inclusion criteria: 1. written informed consent must be obtained before the beginning of te study 2. nonresponder rrms patients 3. last relapse of the patient should be at least 2 months before study entry. 4. last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry. key exclusion criteria: 1. patients with secondary progressive ms. 2. patients with known contraindications for fingolimod treatment. 3. other coexistent autoimmune diseases 4. pregnant or nursing (lactating) women

Keywords: fingolimod,cytokine,chemokine,rrms
domiciliary vr rehabilitation

Conditions: Hemiparesis; Functional Independence; Movement Disorder; Stroke

Summary: the purpose of this study is to determine whether domiciliary vr-based telerehabilitation is superior than domiciliary occupational therapy for inducing functional gains, enhancing corticospinal excitability, and cortical reorganization.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hemorrhagic or ischemic stroke * subject had the stroke more than 12 months ago. * subject presents mild-to-moderate upper-limbs hemiparesis (proximal medial research council scale\>2) secondary to a first-ever stroke. * age between 45 and 85 years old. * subject has previous experience using the rgs system in the clinic. exclusion criteria: * subject presents a major cognitive impairment (mini-mental state evaluation\> 22).
improving breast health knowledge among women using a gamified metaverse-based platform

Conditions: Health Education; Breast Neoplasms

Summary: this randomized controlled trial aimed to evaluate the effectiveness of mammoverse, a gamified metaverse-based educational platform, in improving breast health knowledge among women in china. participants were randomly assigned to either a gamified or non-gamified version of the platform. both groups received identical educational content, but only the gamified group experienced interactive game elements such as avatars, progress feedback, and rewards. knowledge was assessed at baseline, immediately post-intervention, and at 4-week follow-up. the study found that the gamified platform significantly improved knowledge retention and participant engagement compared to the non-gamified version. this clinicaltrials.gov registration reflects only the randomized controlled trial (rct) portion of a broader mixed-methods study that was approved by the university of malaya research ethics committee (ref: um.tnc2/umrec_3967). the full study protocol includes three methodological approaches, and this registration pertains specifically to the rct component involving the mammoverse platform. other study components are not included in this registration.

mammoverse is a 3d metaverse environment designed to promote breast health knowledge through immersive and interactive learning. the gamified version included user avatars, badges, tasks, and personalized feedback to increase motivation and engagement. the study recruited 72 women aged 18 and above, and used a pre-post-follow-up design. outcome measures were based on an adapted 18-item breast health literacy questionnaire. the trial was conducted entirely online, with ethics approval from the university of malaya research ethics committee.

Eligibility criteria:
inclusion criteria: * female participants aged 18 years and above * able to read and understand chinese * access to a digital device and stable internet connection * willing to provide informed consent exclusion criteria: * cognitive impairment or mental health condition that affects participation * inability to complete the full intervention and follow-up sessions * incomplete baseline assessment

Keywords: gamification health education breast cancer awareness metaverse women&amp;#39;s health digital health literacy
a study of mrna-1283 injection compared with mrna-1273 injection in participants ≥12 years of age to prevent covid-19

Conditions: COVID-19

Summary: the purpose of this study (part 1 and part 2) is to evaluate the relative vaccine efficacy (rve), safety, reactogenicity, and immunogenicity of mrna-1283.222 versus mrna-1273.222 (part 1) and mrna-1283.815 versus mrna-1273.815 (part 2).


Eligibility criteria:
key inclusion criteria: * investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. * for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration. * part 1: has previously received a primary series of an authorized/approved covid-19 vaccine. for participants ≥18 years of age, at least 1 booster dose must have also been received. proof of prior vaccination is required. a heterologous vaccine regimen is acceptable. part 2: no prior vaccination is required. for participants who have been previously vaccinated, proof of vaccination is required. key exclusion criteria: * has had close contact, as defined by the centers for disease control and prevention (cdc), with someone who had a sars-cov-2 infection in the past 14 days, or covid-19 in the past 10 days. * participant is acutely ill or febrile (temperature ≥38.0 degrees celsius \[°c\]/100.4 degrees fahrenheit \[°f\]) 72 hours prior to or at the screening visit or day 1. * any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 181 days prior to screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * has received or plans to receive any licensed vaccine ≤60 days prior to the study injection (day 1) or plans to receive a licensed vaccine within 60 days after the study injection. * has received systemic immunoglobulins or blood products within 90 days prior to the screening visit or plans to receive during the study. * has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study. * has participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study. note: other inclusion and exclusion criteria may apply.

Keywords: mrna-1283.222 mrna-1273.222 mrna-1283.815 mrna-1273.815 sars-cov-2 sars-cov-2 vaccine coronavirus virus diseases messenger rna covid-19 covid-19 vaccine moderna
pharmacotherapy personalization of cancer patients

Conditions: Head and Neck Neoplasms; Oncologic Patients

Summary: treatment personalization could ensure better outcome than standard procedures. it is particularly important in intensive care units where patients received many drugs and procedures. their health status can change very fast. the oncologic patients treated in intensive care units are a special group of patients. factors related to cancer influence extra their health status. the aim of this study is population pharmacokinetic-pharmacodynamic analysis drugs that are routinely used during an analgosedation in icu oncologic patients. analgosedation is monitored by drugs plasma concentration, the depth of sedation (bispectral index) and vital parameters like: systolic and diastolic blood pressure, mean arterial pressure, heart rate. moreover, the tnm staging system, biochemical parameters, the american society of anesthesiologists (asa) physical status classification will be checked like potential factors influencing on pharmacokinetics and pharmacodynamics drugs used in the study.

the oncologic patients are qualified to head and neck tumor resection in general anesthesia. the anesthesia introduction is performed with single dose of midazolam, fentanyl, rocuronium and propofol/etomidate. sevoflurane is used in anesthesia maintenance. patients are transported to icu after operation. then they are kept for several hours in analgosedation. all used drugs are given by intravenous continuous infusion. oxycodone is an analgesic component of analgosedation. midazolam, dexmedetomidine and/or propofol are used as sedatives (2-3 drugs in every patient). whole blood samples (2.0 ml) are collected during the study to measure drugs concentrations - 3-4 times during infusion, 5, 10, 15, 30, 60 minutes and 2, 4, 6 hours after the infusion cessation. vital parameters and bispectral index are monitored during analgosedation and 6 hours after the infusion cessation and noted every 15-60 minutes.

Eligibility criteria:
inclusion criteria: * age over 18 years old, * qualifications to oncologic surgery, * needing of analgosedation in icu after an operation exclusion criteria: * proven allergies to used in anesthetics or/analgosedation medicaments, * lack of written confirmed consent of a patient

Keywords: anesthesia intensive care units pharmacokinetics pharmacodynamics surgical patients analgosedation
side pole static ankle foot orthosis in children with neurological disorders

Conditions: Neurological Disorder

Summary: transverse-plane foot deformities are a frequently encountered issue in children with neurological disorders. they are the source of many symptoms, such as pain and walking difficulties, making their prevention very important. it is thus important to prevent the occurrence of transverse-plane foot deformities and limit their development regarding the high risk of morbidity. in order to prevent such deformities, in the department of pediatric physical medicine and rehabilitation department of lyon, since 2001 the investigator use a side pole static ankle foot orthosis (sps afo) in children with a neurological disorder predisposing such deformities. the aim of the study this study is to describe the use, tolerability and potential side effects of this orthosis in children with neurological disorders from the investigator's department


Eligibility criteria:
inclusion criteria: * regularly follow-up in the department of physical medicine and pediatric rehabilitation l'escale (lyon, france) * presenting at least unilateral transverse-plane foot deformity within the context of a neurological disorder * having a first prescription of sps afo between december 2001 and december 2011. exclusion criteria: * none

Keywords: foot deformity orthopaedic management prevention side pole static ankle foot orthosis
time to dmard (disease-modifying anti-rheumatic drug) treatment and actual work limitation of patients with rheumatoid arthritis in turkey

Conditions: Rheumatoid Arthritis

Summary: the objective is to measure time delay from onset of symptoms to diagnosis and time to disease-modifying anti-rheumatic drug treatments in turkish patients with rheumatoid arthritis. the investigators will also evaluate actual work limitation status of patients and impact of demographic and clinical factors on work limitations in rheumatoid arthritis patients.

this post marketing observational study will be conducted in cross-sectional, non-interventional, multi-center format in turkey. as this is a post marketing observational study, abbott is not involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription. subjects will be recruited from rheumatology outpatient clinics of university hospitals and/or private offices. patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data will be included. patient data will be collected with a single visit. during the single visit, all required demographic and clinical data will be recorded on the case report forms by the investigators and every subject will be asked to fill out the work productivity and activity impairment questionnaire and the health assessment questionnaire - disability index.

Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis by a specialist or by the treating rheumatologist * treated with at least one disease-modifying anti-rheumatic drug or biologics * patients over 18 years * patients already employed at a paid work * patients able to provide data for disease history * able to provide written consent to release information for this study exclusion criteria: * patients who cannot provide necessary outcome measurements for any reason will be excluded from the study

Keywords: rheumatoid arthritis disease-modifying anti-rheumatic drug work limitation
vibrotactile coordinated reset (vcr) for the treatment of advanced parkinson's disease patients who have previously received vcr stimulation

Conditions: Parkinson Disease

Summary: the purpose of this study is to test the efficacy of vibrotactile coordinated reset(vcr) stimulation on human subject participants with advanced stage parkinson's disease who have previously received vcr therapy.


Eligibility criteria:
inclusion criteria: * any adult age 18 and older * idiopathic parkinson's symptoms between hoehn and yahr stages 2 to 4 * fluent in english * if patient is on medication that affects brain function or alters electroencephalography (eeg) activity, the patient must feel comfortable going off this medication prior to eeg recording * appropriate social support if required during an off state. * comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes. * feels comfortable going off parkinson's disease(pd) related medication during in person study visits * lives in the united states * having previously been enrolled in a vcr pilot study exclusion criteria: * any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies * any current drug or alcohol abuse. * participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. any other trial participation should be approved by the principal investigators. * pregnancy, breast-feeding or wanting to become pregnant * physical limitations unrelated to pd that would affect motor ratings * craniotomy * brain surgery * patient is unable to communicate properly with staff (i.e., severe speech problems) * excessive drooling * a type of hairstyle that would impede the use of an eeg cap * sensory abnormalities of the fingertips * patient is taking a medication that may cause significant withdrawal effects. * presence or diagnosis of essential tremor, psychogenetic tremor, functional tremor and any other non- pathological or non-parkinsonian tremors

Keywords: parkinsons vibrotactile stimulation vibration pd non-invasive
imt in ventilatory muscle metaboreflex in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this research intends to evaluate if inspiratory muscle training (imt) reduces inspiratory muscle metaboreflex through the decrease of calf vascular resistance and increase of calf blood flow in chronic obstructive pulmonary disease (copd).

patients will be selected from the hospital de clinicas de porto alegre's copd ambulatory, by convenience. afterwards, patients will be submitted to pulmonary function test (spirometry) and cardiopulmonary exercise tests (incremental and submaximal), maximal inspiratory pressure evaluation and induction of the inspiratory muscle metaboreflex through venous occlusion plethysmography. disease specific health related quality of life questionnaire (saint george respiratory questionnaire) and daily life dyspnea questionnaire (baseline dyspnea index and transitional dyspnea index) will be administered at the first and last visit of each subject. patients will undergo inspiratory muscle training for 30 minutes per day, 7 times a week, for 8 weeks, with inspiratory muscle trainer device (powerbreath inc.). there will be a weekly follow up at the institution's clinical research center, where maximal inspiratory pressure (pimax) and inspiratory training techniques will be reevaluated. after this period, tests of pulmonary function, questionnaires exercise tolerance and induction of the inspiratory muscle metaboreflex will be reevaluated.

Eligibility criteria:
inclusion criteria: selection of subjects will be made through the hospital de clinicas de porto alegre pneumology service's copd ambulatory. the inclusion criteria consist of -patients with copd with functional confirmation through spirometry as by previously defined criteria. those selected must be classified as gold ii-iv, with moderate to severe expiratory flow obstruction. exclusion criteria: patients will be considered ineligible for this study if they * develop copd exacerbation 8 weeks prior to recruitment * if systemic corticosteroids are utilized (in the last three months) * if there is history of acute myocardial infarction (in the last three months) * if there is presence of neuromuscular disease * history of cardiovascular disease or active smoking (in the last 6 months) * clinical history of peripheral vascular disease and if age is equal or superior to 85 years

Keywords: pulmonary rehabilitation inspiratory muscle training inspiratory muscle strength vascular resistance exercise chronic obstructive pulmonary disease
strategy-confirming study of bms-955176 to treat hiv-1 infected treatment-experienced adults

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate whether the combination of bms-955176 with atazanavir (atv) \[with or without ritonavir (rtv)\] and dolutegravir (dtg) is efficacious, safe, and well-tolerated in hiv-1 infected treatment experienced adults.


Eligibility criteria:
inclusion criteria: * men and non-pregnant women, at least 18 years of age * antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (arv) (with or without documented resistance) * cd4+ t-cell count \> 50 cells/mm3 * screening genotype/phenotype indicating susceptibility to study drugs (unboosted atv, fc \< 2.2; dtg; tdf) exclusion criteria: * antiretroviral treatment-experienced adults who have failed \> 2 arv regimens * resistance or partial resistance to any study drug determined by tests at screening * historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to atv, tdf, ral, protease inhibitors, and certain tams * chronic hepatitis b virus (hbv)/ hepatitis c virus (hcv) * blood tests that indicate normal liver function * hemoglobin \< 8.0 g/dl, platelets \< 50,000 cells/mm3
effect of topical aqueous suppressants on intraocular gas duration following pars plana vitrectomy

Conditions: Macular Hole; Retinal Detachment

Summary: the purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any effect on the duration of an intraocular gas bubble following pars plana vitrectomy.

at the end of some retinal surgeries, a gas bubble is placed in the eye. in surgeries for retinal detachment, this gas bubble helps to keep the tear(s) in the retina sealed up while the eye is healing and prevent the retina from re-detaching. in macular hole surgeries (a defect in the center part of the retina), the gas bubble helps to seal up this hole in the center part of the retina. the gas bubble (sulfur hexafluoride) will slowly disappear from the eye over the course of approximately 2 weeks. in some cases, the gas bubble disappears more quickly than the surgeon would wish. several eye drops are currently available which help to lower the eye pressure in conditions such as glaucoma where the eye pressure is unacceptably elevated and is causing or may cause vision loss. these drops have been shown to keep the eye pressure controlled after surgery with injection of a gas bubble in the eye. however, little is known about the effect of these drops on the duration of the gas bubble. the goal of this study is to see if these glaucoma eye drops have any effect on the amount of time the gas bubble remains in the eye. after surgery with a gas bubble (sulfur hexafluoride) is completed, patients will be randomly assigned (like a flip of a coin) to receive a glaucoma drop (dorzolamide-timolol) or no glaucoma drop. these drops are currently available from pharmacies with a prescription and are not "experimental." however, the use of these drops in this protocol is not to treat glaucoma but represents an "off-label" use. patients assigned to receive a glaucoma drop will be provided with the medication. all patients will receive the standard post-operative drops regardless of which group they are assigned to. patients will be taken care of before and after the surgery like any other patient undergoing this procedure. the investigators expect that you will be enrolled in this study for 3 months.

Eligibility criteria:
inclusion criteria: * patients scheduled for pars plana vitrectomy with intraocular gas tamponade with sulfur hexafluoride (e.g., retinal detachment, macular hole, other condition at the discretion of the investigator). * ability to provide written informed consent and comply with study assessments for the full duration of the study. exclusion criteria: * prior trabeculectomy or tube shunt surgery. * current use of topical aqueous suppressants or other glaucoma medications. * aphakia or presence of anterior chamber intraocular lens implant. * known allergy or contraindication to sulfa or beta-blocker use (e.g., asthma, chronic obstructive pulmonary disease, bradycardia).

Keywords: vitrectomy gas bubble retinal detachment macular hole aqueous suppressant