Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of biib019 (daclizumab high yield process) versus interferon β 1a in participants with relapsing-remitting multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary study objective is to test the superiority of daclizumab high yield process (dac hyp) compared to interferon β 1a (ifn β-1a) in preventing multiple sclerosis (ms) relapse in participants with relapsing remitting multiple sclerosis. the secondary study objectives are to test the superiority of dac hyp compared to ifn β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.


Eligibility criteria:
key inclusion criteria: * must have a confirmed diagnosis of relapsing remitting multiple sclerosis (rrms), and a cranial magnetic resonance imaging (mri) demonstrating lesion(s) consistent with ms * must have a baseline expanded disability status scale (edss) between 0.0 and 5.0, inclusive * male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment key exclusion criteria: * known intolerance, contraindication to, or history of non-compliance with avonex® 30 µg * history of treatment with daclizumab high yield process (dac hyp) * history of malignancy * history of severe allergic or anaphylactic reactions * known hypersensitivity to study drugs or their excipients * history of abnormal laboratory results indicative of any significant disease * history of human immunodeficiency virus (hiv) or other immunodeficient conditions * history of drug or alcohol abuse (as defined by the investigator) within the 2 years prior to randomization * history of seizure disorder or unexplained blackouts or history of a seizure within 6 months prior to baseline * history of suicidal ideation or an episode of clinically severe depression (as determined by the investigator) within 3 months prior to day 1 * an ms relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization * known history of, or positive screening test result for hepatitis c virus or hepatitis b virus * varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening * exposure to varicella zoster virus within 21 days before screening note: other protocol-defined inclusion/exclusion criteria may apply.
rocket study: a study to characterize biomarkers and disease progression in participants with pelizaeus-merzbacher disease

Conditions: Pelizaeus-Merzbacher Disease

Summary: the purpose of the study is to prospectively assess longitudinal changes in proteolipid protein 1 (plp1) protein, disease-related biomarkers in cerebral spinal fluid (csf) and blood, neuroimaging parameters relevant to pelizaeus-merzbacher disease (pmd) and longitudinal changes in performance on clinical, participant, and caregiver-reported outcome assessments to inform the development of therapies for pmd.

this is a multi-center, non-randomized, non-interventional integrated prospective and retrospective study in up to 32 participants with pmd who can undergo general anesthesia or conscious sedation (if necessary) to collect fluid biomarkers (csf and blood), neuroimaging, and clinical assessments to be used in support of the development of therapies for pmd. the study duration for each participant will be approximately 26 months (week 106).

Eligibility criteria:
inclusion criteria: 1. participant has a parent or caregiver capable of providing informed consent (signed and dated) and able to attend all scheduled study visits and provide feedback regarding the participant's symptoms and performance as described in the protocol and be able to comply with all study requirements 2. participant has a diagnosis of pelizaeus-merzbacher disease with genetic confirmation of plp1 duplication 3. male, 6 months-17 years old, inclusive, at the time of informed consent and phenotype consistent with classic pmd 4. no contraindications for lumbar punctures (lps), blood draws, neuroimaging, sedation (if necessary) or other study procedures exclusion criteria: 1. clinically significant abnormalities in medical history or physical examination 2. \> 2 copies of the plp1 gene 3. have any other conditions, which, in the opinion of the investigator would make the participant unsuitable for inclusion, or could interfere with the participant taking part in or completing the study

Keywords: pmd
a study of adalimumab in japanese subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult japanese subjects with recent onset of rheumatoid arthritis.

this was a phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult japanese patients with early rheumatoid arthritis (ra) who had not been previously treated with methotrexate (mtx). eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. all participants also received 6 mg to 8 mg mtx weekly as basal treatment for their disease. participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at week 12, 16, or 20 compared with baseline after having increased mtx dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. participants who completed the 26 weeks of treatment (either double-blind study drug \[adalimumab or placebo\] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. efficacy and safety assessments were performed at baseline and at designated study visits.

Eligibility criteria:
inclusion criteria * rheumatoid arthritis based on the american college of rheumatology criteria * methotrexate or leflunomide naïve * disease duration less than or equal to 2 years from diagnosis exclusion criteria * history of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active tb, hiv * previously received anti-tnf therapy anti-il-6 receptor antibody, ctla4-ig, anti-cd20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus * joint surgery involving joints to be assessed within 8 weeks prior to screening

Keywords: rheumatoid arthritis
pilot simulation rct of telemedical support for paramedics

Conditions: Respiratory Failure; Status Epilepticus; Status Asthmaticus; Cardiopulmonary Arrest

Summary: this study evaluates the impact of video communication via telemedicine on the quality of emergency care provided to children by paramedic teams supported by a remote physician in a simulated out-of-hospital setting. half of the paramedic teams will use a video telemedicine platform for communication with a physician, while the other half will use an audio-only platform.

in the united states, the current standard of pre-hospital (out-of-hospital) emergency care for children with life-threatening illnesses in the community includes remote physician medical direction for paramedics providing life-saving therapies while transporting the child to the hospital. most pre-hospital emergency medical service (ems) agencies use radios systems for audio communication between paramedics and physicians. this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. the purpose of this pilot study is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life-threatening illnesses. paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. because real pediatric life-threatening illnesses are rare, high-stakes events and involve a vulnerable population (children), this pilot randomized control trial will provide early data on the efficacy of this intervention in simulated cases of pediatric medical emergencies. the primary outcome is "paramedic resuscitation performance" measured by a checklist of observable critical actions by independent reviewers during live observation and video review. the results of this study will provide important pilot data to estimate the clinical effect of this intervention and the sample size needed for a future definitive trial with children, a vulnerable population.

Eligibility criteria:
inclusion criteria: * certified paramedics from three ems systems in the boston metropolitan area (boston ems, south shore ems, and lahey medical center ems) * attending physicians and clinical fellows with expertise in pediatric emergency medicine and pediatric resuscitation from 2 pediatric referral centers (boston medical center and boston children's hospital) exclusion criteria: -prehospital providers without paramedic level certification (e.g. bls certification only)

Keywords: prehospital emergency care paramedic performance telemedicine medical control physician infant mannequin smulation pediatric life threatening illness
establish a ct images database of patients with congenital heart disease

Conditions: Heart Diseases

Summary: setup ct images database of congenital heart disease.

setup ct images database of congenital heart disease.

Eligibility criteria:
inclusion criteria: - congenital heart disease exclusion criteria: -

Keywords: ct children congenital
efficacy and safety of a fully covered self-expandable metal stent for unresectable hcc

Conditions: Malignant Biliary Obstruction; Hepatocellular Carcinoma

Summary: the effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by hcc are still unknown. these would be clarified in this prospective cohort study.

in this study, endoscopic biliary drainage was performed using fully covered self-expancdable metal stent for malignant biliary obstruction caused by hcc. main outcome is efficacy and safety of this procedure including clinical success rate, technical success rate, stent patency, stent dysfunction, and any adverse events during the follow-up period.

Eligibility criteria:
inclusion criteria: * adults aged 19 years or older, those who consented to the clinical research participation and signed a written consent form * obstructive jaundice caused by unresectable hepatocellular carcinoma exclusion criteria: * patients who have previously undergone surgical biliary drainage * patients who need to remain percutaneous transhepatic biliary drainage * patients whose life expectancy is less than 3 months (bclc stage d without a treatment plan for hepatocellular carcinoma) * patients who cannot undergo endoscopic procedure according to the judgment of the researcher

Keywords: self expandable metal stent
baduanjin exercising effects on sub-clinical hypothyroidism and cognitive problems

Conditions: Subclinical hypothyroïdism; Cognitive Impairment

Summary: females with sub-clinical hypothyroidism may exhibit frequent cognitive problems especially if they are elderly

females (forty in number) with sub-clinical hypothyroidism exhibit cognitive problems, they are elderly, will be divided to exercised group (baduanjin training will be applied 5 times per the week, under supervision for 12 weeks, number of patients will be 20) and other non exercised group (number of patients will be 20) . all women of groups will received their prescribed daily one-dose medication tablet (levothyroxine).

Eligibility criteria:
inclusion criteria: * female with sub-clinical hypothyroidism * females with mild cognitive impairment * females with obesity (obesity class one) exclusion criteria: * neurological problems * orthopedic problems
the effects of lavender aromatherapy on reducing stress and anxiety during mri procedures.

Conditions: Anxiety

Summary: research question: what effect if any does the use of lavender aromatherapy have on a patient's stress and anxiety during the mri procedure in the cardiovascular services department? hypothesis: 1. the use of lavender aromatherapy will reduce anxiety by 20% during mri procedures. 2. mri cancellations related to stress and anxiety will decrease by 10%. sample size of 30 patients is needed for the control group and the lavender aromatherapy group, for a total of 60 patients. rationale: patients undergoing mri procedures may experience stress and anxiety related to the small and confining space required during the scan. anyone with a history of claustrophobia, panic attacks, or fear of enclosed spaces is more likely to experience symptoms of panic, fear, or anxiety during the mri procedure (harris, cumming, \& menzies, 2004, p. 1). this stress and anxiety may cause the patient to abort the scan, the patient may refuse future scans, or the patient's nervous tremors or involuntary quivering may adversely affect the images obtained. lavender aromatherapy has been shown to reduce stress and anxiety for patients in other settings; however, its use during mri procedures has not been studied. this project investigates the use of lavender aromatherapy as a non-pharmacological way to help patients relax during their mri procedure. lavender aromatherapy has been studied and shown to reduce stress and anxiety for patients in other situations, but it has not been studied during mri procedures. lavender is known to be uplifting, as well as soothing and helpful for reducing stress, anxiety, depression, and insomnia (herz, 2007, p. 264). if aromatherapy proves useful as an agent to reduce stress and anxiety, patient satisfaction with their mri procedure will increase and the need for sedating medication could decrease.


Eligibility criteria:
inclusion criteria: * english speaking * able to voluntarily provide consent * undergoing elective mri procedure exclusion criteria: * lavender sensitivity or allergy

Keywords: stress anxiety mri aromatherapy
the role of cd34 + stem cells and biomarkers in the development of cav in htx patients

Conditions: Vasculopathy; Heart Transplant Failure

Summary: coronary allograft vasculopathy represents one of the major limiting factors of long-term survival in heart transplant recipients. while extensively researched, the underlying mechanisms of coronary allograft vasculopathy (cav) after heart transplantation remain incompletely understood. as cd34+ cells represent one of the key determinants of coronary vascular homeostasis we investigated the potential association between cav and cd34+ cell count in heart transplant recipients.

in a single-center prospective pilot cohort study, we aim to enroll 55 adult heart transplant recipients. all patients will undergo coronary ct angiography and the presence of cav will be defined in accordance with the ishlt criteria. at the time of ct angiography, patient will undergo detailed clinical evaluation, cardiac echo and we will also collect blood samples, perform extensive biochemical analysis and measure cd34+ cell count in peripheral venous blood using beckman-coulter navios ex flow cytometry with standard antibodies according to isage protocol. biomarkers of angiogenesis will be evaluated using luminex assay kit.

Eligibility criteria:
inclusion criteria: * heart transplant recipient * age \> 18 years * signed informed consent exclusion criteria: * multiorgan transplantation * egfr \< 30 ml/min * known hypersensitivity to the contrast media * history of any malignancy treated with radiation or chemotherapy * therapy with mtor inhibitors * rejection \> 1r within 90 days before enrollment * g-csf therapy within 30 days of enrollment

Keywords: coronary allograft vasculopathy cd34+ stem cells
bioaerosol sampling device (bsd) clinical study

Conditions: COVID-19

Summary: the goal of this clinical trial is to learn about the bioaerosol sampling device (bsd) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of covid-19 viral particles in patients seeking to be tested for covid-19.

sars-cov-2, the virus which causes covid-19, is transmissible through bioaerosols. routine accessible, non-invasive, sensitive testing could play a role in reducing the spread of the disease and controlling the current and future pandemics. the bioaerosol sampling device may offer both comfort and the potential to increase the ability to detect patients earlier in the infection cycle than a swab. the primary objective of the research is to generate bsd performance data with detection by rt-pcr and at-home molecular and antigen assays, compared to nasal swab comparator detected by eua or 510k cleared rt-pcr.

Eligibility criteria:
inclusion criteria: any patient 5 years or older who wants to be tested patients may be symptomatic or asymptomatic based on cdc guidelines patients may be suspected of having covid-19 based on cdc guidelines patient's covid-19 status should be unknown patients younger than 12 should be assisted by an adult exclusion criteria: unable to self-consent concurrent enrollment in other trials involving same-day nasal cavity sampling contraindication to nasal sampling as performed according to the clinical site policies and procedures, including: unable to tolerate nasal swab sampling history of perforation of the nasal septum or prone to nosebleed head or facial injury/surgery within the past 6 months on anticoagulant therapy including anti-platelet therapy nasal or nasal aspirate and nasal wash performed as standard of care.

Keywords: covid-19 rapid diagnostic test sars-cov-2 sars-cov-1
cochlear trauma, functional and structural preservation in cochlear implant surgery

Conditions: Hearing Loss; Cochlear Implant; Cochlear Microphonics; Electrocochleography

Summary: prospective 2-arm cohort consisting of a preoperative visit and visits at the time of implantation (day 0) and follow-up in patients for whom their treating physician indicated a perimodiolar or straight cochlear implant.

branches: * perimodiolar (pm) * lateral wall (pl) follow up schedule: preoperative visit pov1 (up to 90 days before d0) intraoperative visit d0 (surgery - day 0) follow-up visit 1 fuv1 (48 hours) follow-up visit 2 fuv2 14 days follow-up visit 3 fuv3 (4 weeks) follow-up visit 4 fuv4 (3 months) follow-up visit 5 fuv5 (6 months) follow-up visit 6 fuv6 (12 months)

Eligibility criteria:
inclusion criteria: patients to receive a cochlear implant 12 months of age or older at the time of incorporation willingness to participate and comply with the requirements of the protocol residual hearing better than 80 dba at 500 hz exclusion criteria: medical or pharmacological comorbid condition that contraindicates cochlear implantation. previous implantation in the ear of the new implant ossification or any other cochlear abnormality that could prevent the complete insertion of the electrode guide abnormal cochlear / neural anatomy on preoperative ct or mri (excluding dilated vestibular aqueduct syndrome) deafness due to lesions of the central auditory pathway. (exclusion for evaluation of residual hearing) diagnosis of auditory neuropathy spectrum disorder (exclusion for evaluation of residual hearing) active infection in the middle ear chronic inflammatory processes in the middle ear disabilities that could prevent participation in the evaluations unrealistic expectations on the part of the participant regarding the possible benefits, risks and limitations inherent to the procedure or research protocol. surgical impossibility to follow the guidelines of the minimally traumatic technique.
cerave diabetes mellitus

Conditions: Diabetes Complications

Summary: the purpose of this study is to evaluate the safety and efficacy of the cerave diabetic skin line for the improvement of skin condition in patients with diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. men or women between the ages of 18 and 75 years of age. 2. willing to provide written informed consent. 3. a diagnosis of diabetes mellitus (dm). 4. dm-related skin changes classified into one or more of the following four categories: i) skin lesions associated with dm; ii) infections; iii) cutaneous manifestations of dm complications; iv) skin reaction to dm treatment. exclusion criteria: 1. history of allergy, anaphylaxis or hypersensitivity to any of the ingredients in cerave hydrating cleanser or moisturizing cream 2. history of allergic contact dermatitis secondary to cleansers or moisturizers. 3. has a heightened immune response to common allergens, especially inhaled, topical or food allergens (atopy). 4. has any clinical manifestation in the treatment are(s) or other disorders that, in the investigator's opinion, may affect assessments or the study products. 5. inability to attend all study visits and follow treatment regimen.

Keywords: cutaneous complication of dm