Kornimate/medical-research-clean huggingface dataset:
the use of technology to improve ms clinical trials and patient care

Conditions: Multiple Sclerosis

Summary: many patients with multiple sclerosis (ms) experience "relapses" of disease activity during which they have increased numbness, weakness, visual problems, or other symptoms. if a person with ms has new symptoms that are concerning to them, their doctor may want to see them in the office in order to confirm that these symptoms are due to a true "relapse" of activity before starting relapse treatment. this requirement can be frustrating for patients, who may have to take time off from work or travel long distances for such unexpected doctors' visits. in this study, the investigators will use input from patients with ms and ms physicians to create a relapse questionnaire that can be used to confirm a relapse has occurred. the investigators will also evaluate if having a more direct line of communication with the provider's office improves overall patient care and satisfaction.

this research is being done to study if a relapse questionnaire for people with multiple sclerosis (ms) may help more easily determine if a relapse has occurred. a further goal of this study is to determine if receiving periodic messages from the doctor's office, as well as having the direct contact information of a person in the office, improves the care of the patients and their experience thereof.

Eligibility criteria:
inclusion criteria: * english speakers * relapsing-remitting ms (2010 criteria) * expanded disability status scale (edss) ≤6.0 * possession of a smartphone or of a mobile telephone with text messaging and an e-mail account and web access or willingness to be provided with, and utilize, a smartphone for the duration of the study * in the two years before screening: at least two relapses, or one relapse and two new lesions (unrelated to relapse symptoms) on magnetic resonance imaging (mri), or rrms (magnims 2010 criteria) onset within the past year with no exposure to disease modifying therapies (dmt) * patient is starting one of the following ms therapies: injectable (subcutaneous interferon beta or glatiramer acetate) or oral (fingolimod, teriflunomide, or dimethyl fumarate) therapies * relapse and mri activity occurred while untreated or despite one single treatment, and no change in therapy since that activity * lives within 100 miles of johns hopkins medical center (baltimore, md) exclusion criteria: * history of dmt exposure if magnims 2010 criteria used to enroll patients with disease onset in the past year, or change in ms therapy since qualifying relapse/mri criteria occurred
effects of fuzheng huayu tablets on covid-19

Conditions: Novel Coronavirus Pneumonia

Summary: the 2019 novel coronavirus (2019-ncov) infection caused clusters of severe respiratory illness similar to sars and was associated with icu admission and high mortality. there is no confirmed antivirus therapy for people infected 2019-ncov, most of them should receive supportive care to help relieve symptoms. this clinical trial is to evaluate the effect of fuzheng huayu tablet on lung inflammation in intensive patients with novel coronavirus pneumonia and reduce the progressive rate to critical type.

in december 2019, new coronavirus pneumonia (ncp) occurred in wuhan, hubei province, which spread rapidly. some of the patients developed into severe or critical illness. it became an international concerned public health emergencies and one of the major epidemics seriously endangering people's health and public safety after severe acute respiratory syndrome (sars) in 2003. at present, we lack the specific treatment for ncp. the anti- novel coronavirus drugs are been conducting in clinical trials, and the other options includes the symptomatic treatment. the pathological mechanism of the disease is not clear, but due to the continuous development of inflammation, some cases can become severe or critical, which threatening the life and health of patients. intensive cases with obvious inflammation, after the control of acute symptoms and signs, often have the performance of pulmonary fibrosis, affecting the recovery of lung function. therefore, actively reducing lung inflammation, controlling and reversing pulmonary fibrosis is of great significance for the life and health of patients infected novel coronavirus. our previous study found that fuzheng huayu prescription can reduce the inflammation and fibrosis of the lung in the model rats, and improve the lung function of the patients with copd. therefore, we hope to take fuzheng huayu tablet to ncp patients, and observe whether it can reduce the lung inflammation of patients, so as to reduce the rate of progression of critical illness.

Eligibility criteria:
inclusion criteria: patients were included if they (1) had covid-19; (2) were 18 to 65 years old; (3) did not participate in other drug clinical studies within 1 month before enrollment; and (4) voluntarily accepted treatment and signed an informed consent form. exclusion criteria: patients were excluded if they (1) had critical covid-19; (2) were unconsciousness, had dementia, had psychiatric conditions, or were unable to communicate normally; (3) had severe cardiac insufficiency (i.e., cardiac function grade iv), severe liver or kidney disease, bronchial asthma, copd, neurological disease, tumor, thoracic deformity, or immunodeficiency disease; (4) were pregnant or lactating or had a recent pregnancy plan; and (5) had a known allergy to any treatment drug.
study to evaluate the safety, tolerability, and immunogenicity of v114 in healthy japanese infants (v114-033)

Conditions: Pneumococcal Infections

Summary: the purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of v114 compared with pneumococcal 13-valent conjugate vaccine (pcv13). the hypotheses are that: 1) v114 is non-inferior to pcv13 for the 13 shared serotypes between v114 and pcv13 based on the response rates at 30 days following dose 3; 2) v114 is non-inferior to pcv13 for the 2 unique v114 serotypes based on the response rate of the 2 unique v114 serotypes at 30 days following dose 3; 3) v114 is non-inferior to pcv13 for the 13 shared serotypes between v114 and pcv13 based on anti-pneumococcal polysaccharide (pnps) serotype-specific immunoglobulin g (igg) geometric mean concentrations (gmcs) at 30 days following dose 3.


Eligibility criteria:
inclusion criteria: - japanese male or female exclusion criteria: * has a history of invasive pneumococcal disease (ipd) * has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (pcv), or any diphtheria toxoid containing vaccine * has a known or suspected impairment of immunological function * has a history of congenital or acquired immunodeficiency * has or his/her mother has a documented human immunodeficiency virus (hiv) infection * has or his/her mother has a documented hepatitis b surface antigen-positive test * has known or history of functional or anatomic asplenia * has a history of autoimmune disease * has a known neurologic or cognitive behavioral disorder * has received a dose of any pneumococcal vaccine prior to study entry * has received a blood transfusion or blood products, including immunoglobulins
a study comparing valsartan with and without hydrochlorothiazide in patients with hypertension

Conditions: Hypertension

Summary: safety extension study to the core study cvah631c2301


Eligibility criteria:
inclusion criteria: successful completion of study cvah631c2301 - exclusion criteria: * none

Keywords: hypertension, valsartan
monthly replacement orthokeratology for myopia control in existing lens wearers

Conditions: Myopic Progression

Summary: the two-year prospective study aims at investigating the benefits of frequent replacement (monthly) orthokeratology lenses in myopia control in terms of effectiveness in control and prevention of ocular complications. the secondary objective will be investigating the use of weekly protein removal system in monthly replacement modality orthokeratology lenses on surface deposit.

this is a two-year randomized trial. existing orthokeratology lens wearers (aged 8-13 years), who have completed a 2-year myopia control using orthokeratology, will be recruited and monitored for another two years. eligible subjects will be randomly assigned to monthly or yearly replacement modality. axial elongation and ocular conditions will be compared between the monthly and yearly replacement groups. subjects on monthly replacement lenses will be randomly assigned to normal cleaning and intensive cleaning groups. subjects in normal cleaning group will be provided with complimentary contact lenses solutions for daily cleaning and disinfection. in addition to the daily procedures for lens case, subjects in the intensive cleaning group will be required to perform weekly protein removal. all subjects on yearly replacement lenses will be required to performed intensive cleaning such that they will follow normal daily cleaning and disinfection as well as weekly protein removal.

Eligibility criteria:
inclusion criteria: * aged 8-15 years * have completed a two-year myopia control study using ortho-k * normal ocular and general condition and not on medication which may contraindicate ortho-k lens wear * pre-ortho-k refractive sphere between -0.75 to -4.00 ds, refractive cylinder ≤ -1.50 dc and anisometropia ≤ -1.00 d * best correctable vision better than 0.08 logmar in the worse eye * normal binocular function and accommodative status exclusion criteria: * strabismus at distance or near * contraindication for ortho-k lens wear * prior history of ocular surgery, trauma, or chronic ocular disease * systemic or ocular conditions that may interfere refractive development * systemic or ocular conditions that may interfere tear quality and contact lens wear * poor response to the use of study lenses * poor compliance to test procedures * poor compliance to the use of ortho-k lenses (e.g. use of solution, use of lenses) * poor compliance to follow-up schedule

Keywords: myopia progression orthokeratology replacement modality surface deposits
effect of chemotherapy on pd-l1 in nsclc

Conditions: Chemotherapy; Immunotherapy; PD-L1

Summary: pd-l1 is identified as an important biomarkers for predicting pd-1/pd-l1 inhibitors in advanced non-small cell lung cancer. several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of pd-1/l1 immunotherapy in nsclc such as checkmate-227, impower-150, keynote-189, etc. pre-clincial experiment shows that chemotherapy could increase cd8 til infiltration in tumor microenvironment, activate t cell immune reaction. however, it remains unclear whether chemotherapy could affect pd-l1 in advanced nsclc patients. the present study aims to evaluate whether pd-l1 will change after receiving chemotherapy in advanced nsclc patients.


Eligibility criteria:
inclusion criteria: * advanced nsclc diagnosed histologically; expected survival ≥ 6 month; * without druggable molecular events (egfr, alk, c-met, braf, ret, etc) * ecog / ps score: 0-2, and the main organ function to meet the following criteria: hb ≥ 90g / l, anc ≥ 1.5 × 109 / l, plt ≥ 80 × 109 / l,bil \<1.5 times the upper limit of normal (uln); liver alt and ast \<2.5 × uln and if liver metastases, alt and ast \<5 × uln; serum cr ≤ 1 × uln, endogenous creatinine clearance ≥50ml/min exclusion criteria: * patient can not comply with research program requirements or follow-up; * patient will receive immunotherapy;
the effectiveness and safety of vagus nerve stimulation for tre

Conditions: Tuberous Sclerosis Complex; Epilepsy

Summary: prospective cohort studies to identify clinical epilepsy control, cognitive changes, and safety of vns in patients with tuberous sclerosis complex-related epilepsy.

this study aims to evaluate the efficacy and safety of vagus nerve stimulation (vns) in the treatment of drug-resistant epilepsy in patients with tuberous sclerosis complex (tsc) and compare it with traditional antiepileptic drug therapy. by assessing seizure frequency, severity, and improvements in quality of life, the study seeks to provide evidence-based guidance for clinical treatment strategies.

Eligibility criteria:
inclusion criteria: * age range: patients aged 1 to 18 years. * confirmed diagnosis: diagnosed with tuberous sclerosis complex (tsc) according to established diagnostic criteria. * drug-resistant epilepsy: ineffectiveness of at least two antiepileptic drugs (monotherapy or combination therapy). * informed consent: patients and their guardians understand the purpose of the study and voluntarily sign the informed consent form. exclusion criteria： * other severe diseases: presence of significant cardiovascular, respiratory, or other systemic diseases. * psychiatric disorders: history or presence of severe psychiatric disorders (e.g., schizophrenia or major depressive disorder). * surgical contraindications: unsuitability for general anesthesia or factors affecting surgical safety. * drug allergy: known allergy to drugs used in the study. * implant conflict: presence of implanted medical devices that may interfere with vns therapy. * pregnancy or lactation: pregnant or breastfeeding individuals. * poor compliance: inability to adhere to follow-up visits or treatment protocols.

Keywords: tuberous sclerosis complex epilepsy vagus nerve stimulation
predicting biomarker of gastric cancer chemotherapy response

Conditions: Gastric Cancer; Chemotherapy Effect; Predictive Cancer Model

Summary: * discovery and validation of biomarker predicting gastric cancer chemotherapy response * analysis for expression level of mrna using next generation sequencing in gastric cancer tissue by chemotherapy response * analysis for expression level of mirna using next generation sequencing in gastric cancer tissue and blood by chemotherapy response * validation of mrna and mirna using qrt-pcr in multiple independent cohort * biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response

* discovery and validation of biomarker predicting gastric cancer chemotherapy response * analysis for expression level of mrna in fresh frozen gastric cancer tissue by chemotherapy response (a) method of mrna expression measurement: rna sequencing (b) study group palliative chemotherapy (inoperable patients) * institutional primary chemotherapy regimen (xp or xelox) 1. response group 2. progression group post-op adjuvant chemotherapy * institutional primary chemotherapy regimen 1. complete response group 2. non-responder group 1. and 2) groups: age, sex, regimen matched * analysis for expression level of mirna using next generation sequencing in gastric cancer tissue and blood by chemotherapy response (a) method of mrna expression measurement: rna sequencing (b) study group * the same patients in mrna sequencing * validation of mrna and mirna in multiple independent cohort method of measurement of rna expression: qrt-pcr * biological biomarkers-clinical factor combined prediction model of gastric cancer chemotherapy response combination of biologic biomarker and clinical factors to predict the chemotherapy response in gastric cancer

Eligibility criteria:
inclusion criteria: * new gastric cancer patients who has scheduled to start 1st cycle of chemotherapy * patients who agreed this study and voluntarily assigned the informed consents. exclusion criteria: * patients who refused the study. * patients who have other cancers * heavy alcoholics

Keywords: gastric cancer rna sequencing chemotherapy response mirna sequencing
video assisted education before ercp

Conditions: Patient Compliance

Summary: it was aimed to study the effect of video assisted education about endoscopic retrograde cholangiopancreaticography (ercp) on anxiety levels of patients who planned to undergo ercp for any reason.video revealing the ercp procedure was shown to the patients in one group and not shown to the other. then anxiety levels and pain scores have been obtained before and after the procedure in both groups

the study was conducted to determine the effect of video education on anxiety level before the ercp procedure and satisfaction degree after the ercp procedure between september 1st 2017 and december 31st 2018 at bagcilar medipol mega university hospital. patients were grouped into two in a randomized manner. in control arm, patients underwent ercp procedure with the information provided by the gastroenterologist who recommended the procedure. patients in experimental arm, besides the information provided by the gastroenterologist, watched video of ercp procedure and answered all the questions about the procedure by an experienced nurse. a total of 70 patients (35 in each arms) was planned to enroll to the study. state-trait anxiety inventory (stai) form was applied to measure anxiety level and visual analog score (vas) was applied to measure the satisfaction about the procedure.

Eligibility criteria:
inclusion criteria: * over 18 years old * conscious enough to understand the procedure and education * patients who can read * hemodynamically stable patients * mentally stable patients * patients who gave informed consent exclusion criteria: * patients who underwent previous ercp procedure

Keywords: video education ercp anxiety level pain score
telerehabilitation following ankle fractures

Conditions: Ankle Fractures

Summary: background and purpose: ankle fractures represent one of the most common fractures in north america. surgical fixation is often required in the presence of dislocation or instability and has been shown to have a high rate of success. following surgical fixation, physical therapy is commonly utilized to assist in regaining function. advice alone has been shown to be non-inferior to traditional physical therapy for patients post-ankle fracture in two studies. the results of these studies have yet to be repeated in the us. it is the intent of this study to investigate the feasibility of a large clinical trial comparing the results of traditional physical therapy and an internet-based telerehabilitation program. following surgical repair of ankle fractures, patients will be randomized to traditional rehabilitation or telerehabilitation. telerehabilitation may represent an alternative patient option to traditional physical therapy following ankle fracture repair. the results of this study will inform the design of larger multi-site clinical trials investigating the effectiveness of telerehabilitation for this patient population.


Eligibility criteria:
inclusion criteria: * bimalleolar or trimalleolar fracture * repaired with open reduction internal fixation technique * must have access to computer, tablet, or smart phone with internet access exclusion criteria: * severe soft tissue damage associated with injury * physical or mental conditions that will affect patient's ability to participate in independent rehabilitation * non-english speaking

Keywords: rehabilitation telerehabilitation
clinical trial assessing temelimab following rituximab treatment in patients with relapsing forms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: randomized, double-blind, placebo-controlled phase iia clinical study, assessing safety, tolerability, pharmacodynamic effects and pharmacokinetics of temelimab, administered at three different dose levels (18 mg/kg or 36 mg/kg or 54 mg/kg). in this study temelimab is administered subsequently to rituximab therapy, i.e. no co-administration of rituximab and temelimab is done in this study.


Eligibility criteria:
main inclusion criteria: * current diagnosis of rms, based on mcdonald 2017 criteria * having received treatment with rituximab, as per local clinical routine for at least 12 months prior to the screening visit * having received their last dose of rituximab not more than 8 weeks and not less than 4 weeks before randomization (study day 1) * having expanded disability status scale (edss) 2.5 - 5.5 inclusive at screening * present clinical worsening in one or more neurological domains as assessed by edss, ambulatory function as assessed by 6mwt or t25fw, cognitive functioning as assessed by sdmt or increased need of walking aids or pharmacological/procedures for bowel and bladder functions over the last year. main exclusion criteria: * current diagnosis of primary progressive ms (ppms) * any disease other than ms (e.g. myelitis and /or bilateral optic neuritis) that could better explain the patient's signs and symptoms * usage of any of the following medications prior to the screening visit: * any usage of interferon beta, glatiramer acetate, iv immunoglobulin (ivig), dimethyl fumarate or teriflunomide within 12 months prior to screening, * any history of exposure to mitoxantrone, cladribine, alemtuzumab, cyclophosphamide, systemic cytotoxic therapy, total lymphoid irradiation, and/or bone marrow transplantation at any time, * any usage of natalizumab within 24 months prior to screening, * any usage of highly potent immune modulating therapy, such as: ocrelizumab, ofatumumab, fingolimod, siponimod, ozanimod or anti-cytokine therapy, plasmapheresis or azathioprine within 12 months prior to screening, * any usage of any experimental treatment if not washed out for ≥ 5 half-lives or ≥ 12 months (whichever is longer), except rituximab which is allowed before the study. * ctcae grade 2 or greater lymphopenia * any major medical or psychiatric disorder that would affect the capacity of the patient to fulfill the requirements of the study * history or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (nyha class 3 or 4) * any history of cancer with the exceptions of basal cell carcinoma and/or carcinoma in situ of the cervix, and only if successfully treated by complete surgical resection, with documented clean margins and any medically unstable condition as determined by the investigator * pregnant or breastfeeding women

Keywords: relapsing forms of multiple sclerosis gnbac1 human endogenous retrovirus type w herv-w temelimab