Kornimate/medical-research-clean huggingface dataset:
a study of obinutuzumab in combination with chemotherapy in participants with cd20+ b-cell follicular non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this open-label, randomized, phase ib study will assess the safety and efficacy of obinutuzumab given in combination with fc (fludarabine and cyclophosphamide) or chop (cyclophosphamide, doxorubicin, vincristine and prednisolone) or bendamustine induction chemotherapy in participants with cluster of differentiation (cd) 20+ b-cell follicular lymphoma (fl). participants with complete response or partial response after induction therapy may receive maintenance therapy every 3 months for 2 years or until disease progression, whichever comes first. all participants in the induction period of the study will have a safety follow-up visit 28 days after completing the last dose of obinutuzumab + chemotherapy, and will be followed for at least 2 years, unless they are being treated in maintenance or discontinue from the study prior to this time point. participants who complete/discontinue maintenance therapy will also be followed for a period of 2 years after receiving the last dose of obinutuzumab or until progression/new antilymphoma treatment.


Eligibility criteria:
inclusion criteria: * either cd20+ r/r b-cell follicular non-hodgkin's lymphoma (after a maximum of 2 prior chemotherapy regimens) or cd20+ b-cell follicular non-hodgkin's lymphoma with no prior systemic therapy * must have at least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters \[cm\] in its largest dimension by computed tomography \[ct\] scan) * eastern cooperative oncology group (ecog) performance status of 0-2 exclusion criteria: * for r/r participants recruited in obinutuzumab + chop regimen, prior use of anthracyclines. for r/r participants recruited in obinutuzumab + fc regimen, immediate prior treatment should not have contained fludarabine or fluoropyrimidines. for first-line recruited participants, prior systemic therapy * prior administration of rituximab within 56 days of study entry, or 3 months for any radioimmunotherapy * central nervous system lymphoma * history of other malignancies within 2 years of study entry which could affect compliance with the protocol or interpretation of results * known active bacterial, viral (including human immunodeficiency virus \[hiv\]), fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of dosing * contraindication to any of the individual components of chemotherapy (as per local prescribing information), of the selected chemotherapy combination (fc, chop or bendamustine)
accelerometer based objective clinical outcomes of spinal cord stimulation (scs) and peripheral nerve stimulation (pns)

Conditions: Chronic Pain; Back Pain; Neck Pain

Summary: this study is a single site, prospective, observational trial utilizing a wrist-worn accelerometer to evaluate clinical outcomes of scs and pns in the treatment of chronic pain.

up to 150 evaluable subjects will be recruited at this site on an ongoing basis. evaluable subjects are defined as subjects that complete the end of study visit. each subject will be assigned an accelerometer and have data recorded for a seven-day period pre-implant trial to collect baseline data. the accelerometer will also be worn during the trial for a period of up to seven (7) days. if the trial is successful and the subject is implanted, the subject will wear the accelerometer for a seven-day period at least six (6) weeks post-permanent implant. the following assessments will be administered to subjects at the baseline (pre-implant trial) visit, the end of implant trial visit and the end of study visit (8 weeks post-permanent implant): the numerical rating scale (nrs) 11-point scale for pain; the sf-36 health survey; the oswestry disability index (odi). subjects treated for neck pain will also complete the neck disability index (ndi). additionally, the subjects will be asked to complete a subject diary to record average daily nrs scores for days the accelerometer is worn.

Eligibility criteria:
inclusion criteria: subjects enrolled in this study must meet the following criteria: 1. subject is 18 years of age or older 2. subject is a candidate for on label use of a scs or pns device 3. subject is ambulatory 4. subject is able to understand and willing to comply with study procedures and requirements 5. subject is able to provide informed consent to participate in the study exclusion criteria: subjects will be excluded from participation in this study if they meet any one of the following criteria: 1. subject has comorbidities that, in the judgment of the investigator, may confound the reliability of the information acquired in this study 2. in the judgment of the investigator, the subject is not seeking an improvement in physical function as a treatment goal of scs or pns

Keywords: accelerometer spinal cord stimulator peripheral nerve stimulator physical function
clarvista harmoni toric trial with intraoperative exchange

Conditions: Cataract; Corneal Astigmatism; Aphakia

Summary: the purpose of this study was to demonstrate the safety and effectiveness of the harmoni® modular intraocular lens system with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.

subjects were implanted with the harmoni® modular intraocular lens system (hmiol). the eye with the higher corneal astigmatism (study eye) was assigned to cohort 1 and received the harmoni® modular intraocular lens system with a toric optic. the fellow eye was assigned to cohort 2 and received the harmoni® modular intraocular lens system with a non-toric optic during primary implantation, which was replaced with the appropriate optic power (toric or non-toric) during an intraoperative exchange (ioe) procedure. a total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. the total duration of participation for each subject was up to 6 months, which included a day -90 to day -0 preoperative period. alcon research, llc, acquired clarvista medical in 2017. this study was designed and conducted by clarvista medical, inc. the study results were collected, analyzed, and provided by clarvista medical, inc. to alcon research, llc.

Eligibility criteria:
key inclusion criteria * willing and able to return for scheduled treatment and follow-up examinations for up to 6 month study duration. * planned removal of visually significant bilateral cataracts. * pre-existing corneal astigmatism in at least 1 eye. * willing to discontinue contact lens wear for the duration of the study. * best corrected visual acuity (bcva) projected to be 0.2 logarithm minimum angle of resolution (logmar) or lower. * visual symptoms related to cataracts. key exclusion criteria * history of any intraocular or corneal surgery in either eye (including refractive). * pregnant or lactating. * history of any clinically significant retinal pathology or ocular diagnosis in either eye that could alter or limit final postoperative visual prognosis. * history of any ocular condition which could affect the stability of the intraocular lens (iol) in either eye. * uncontrolled glaucoma in either eye (per investigator judgement). * severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements

Keywords: cataract intraoperative exchange intraocular lens astigmatism toric
statin monotherapy and rosuzet tab.(rosuvastatin/ezetimibe) administration in patients with dyslipidemia in korea

Conditions: Dyslipidemias

Summary: a cohort study for comparison of statin monotherapy and rosuzet tab.(rosuvastatin/ezetimibe) administration and statin prescription patterns in patients with dyslipidemia in korea.

the main objective of this study is to evaluate the effect of reducing ldl-c levels after 12 months of administration of statin monotherapy or rosuzet tab.(rosuvastatin/ezetimibe) in patients with dyslipidemia in korea

Eligibility criteria:
inclusion criteria: 1. age≥19 2. subject who is taking or is scheduled to take statins therapy or rosuzet tab. 3. not diagnosed with diabetes 4. subject who can written informed consent voluntarily 5. subject can continue to participate for 12 months on study exclusion criteria: 1. patients for whom use of rosuzet tab. and statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin) 2. a pregnant or nursing woman

Keywords: statin rosuvastatin new onset dm ldl-c
neuromodulation in ms using translingual stimulation

Conditions: Multiple Sclerosis

Summary: the overarching aim of this study is to examine if there is additional benefit to adding trans-lingual electrical stimulation to physiotherapy aimed at improving walking and balance in people with multiple sclerosis (ms).

this is a two arm, participant-blinded, interventionist blinded, and research assessor-blinded rct participants with walking problems due to ms (patient determined disease steps pdds 3-6) will be randomized 1:1 after baseline assessment stratified into 2 arms (lower walking disabilities pdds 3+4, and higher walking disabilities pdds 5+6) following a 14 week balance and walking training intervention, participants will be instructed to continue to exercise independently according to the evidence-based physical activity guidelines in ms for a subsequent 12 weeks. they will be reassessed at the end of that time (follow-up).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple sclerosis * gait deficit due to ms but still able to walk (edss less than 6.5, pdds 3-6) * older than 18 and less than 70 years of age * agree to the study time commitment. exclusion criteria: * currently attending physical rehabilitation for walking and/or balance training, * currently already functional community ambulators (gait speed\>120cm/s) * contra-indications to the use of translingual electrical stimulation (active or suspected malignant tumor; recent bleeding or open wounds in mouth; women who are pregnant, or sensitivity to nickel, gold or copper)

Keywords: physiotherapy walking and balance neurorehabilitation non-invasive cranial nerve neuromodulation
study to evaluate safety & efficacy of sarecycline in treatment of acne

Conditions: Acne Vulgaris

Summary: to evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris


Eligibility criteria:
inclusion criteria: * signed informed consent or assent form * male/female, 9 to 45 years of age, inclusive * body weight between 33 and 136 kg, inclusive * facial acne vulgaris with: * 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones) * no more than 2 nodules * iga score of moderate (3) or severe (4) * negative urine pregnancy test at baseline - females of childbearing potential * agrees to use an effective method of contraception throughout the study * refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study * able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (phi) exclusion criteria: * has a dermatological condition of the face that could interfere with the clinical evaluations * has a history of any of the following: * allergy to tetracycline-class antibiotics or to any ingredient in the study drug * pseudomembranous colitis or antibiotic associated colitis * treated for any type of cancer within the last 6 months * has known resistance to other tetracyclines * has received any of the following treatments within 12 weeks of screening: * systemic retinoids * systemic corticosteroids * androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone) * non-medicated procedures for the treatment of acne (eg, laser, light or thermaclear) * has used any acne affecting treatment without an appropriate washout period * has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period * is pregnant, lactating or planning a pregnancy during the study period * has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, cushings disease or congenital adrenal hyperplasia * has drug-induced acne * has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the investigator or medical monitor, precludes participation in the study * is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study * has previously participated in any clinical trial involving the use of sarecycline * is judged by the investigator to be unsuitable for any reason

Keywords: acne
a platform trial for pediatric participants with obesity or overweight (ly900040)

Conditions: Obesity; Overweight

Summary: the purpose of this pediatric, chronic weight management, phase 3 master protocol (pwmp) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

the pwmp establishes entry criteria for newly enrolled participants across the master and the isas. the isas may start independently of other isas as interventions become available for clinical testing. pwmp results will be reported when all the isa's complete.

Eligibility criteria:
inclusion criteria: * have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening. * obesity as defined by bmi equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[cdc-nchs, 2022\]); or * applies to participant age between 12 and \<18 years old. overweight as defined by bmi equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (cdc-nchs, 2022), and at least 1 weight-related comorbidity, * hypertension * type 2 diabetes (t2d) * prediabetes * dyslipidemia * obstructive sleep apnea * metabolic dysfunction-associated steatohepatitis (mash) or metabolic dysfunction-associated steatotic liver disease (masld) exclusion criteria: * have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to: * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as lap-band® gastric banding, or * any other procedure intended to result in weight reduction. * have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes. * have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * have type 1 diabetes or history of ketoacidosis, or hyperosmolar state. * have hba1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening. * have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
effect of covid 19 infection on fetomaternal outcome

Conditions: COVID-19; COVID-19 Pneumonia; Fetal Growth Retardation

Summary: the novel coronavirus called severe acute respiratory syndrome coronavirus 2 (sars-cov-2) was discovered for the first time in december 2019 in wuhan (china) and the disease it causes is called coronavirus disease 2019 (covid-19). now, this pandemic is rapidly spreading all over the world. pregnant have higher rates of covid-19, associated with hospitalizations, and severe in-hospital outcomes. immune responses may have a potential role in the diagnosis, treatment, and prognosis of patients with covid-19. so we need of identifying biomarkers for disease severity and progression.

it is important to define whether a novel virus is transmissible from a mother to her infant, vertical infection, and there are three possible mechanisms for vertical infection - intrauterine infection (including transplacental and ascending infections), intrapartum transmission (during delivery), and postpartum infection. these mechanisms have important implications that can influence obstetrical management decisions, best practice delivery options, and neonatal care (3). aim of work to detect the effect of time of infection by covid 19 on the fetomaternal outcome including vertical transmission, and the immunological and genetic changes during the disease course. patients and methods: * all pregnant women eligible for the study will undergo detailed medical history. * each patient will have the following data: • patient name. • age. • past medical and surgical history. • menstrual history and contraceptive history: especially emphasis on last menstrual period to determine the exact gestational age. * clinical examination of the patients: - general examination of vital data (blood pressure, pulse, temperature, respiratory rate). cbc, pt, ptt, rbs, alt, ast, serum creatinine), and ultrasound will be done. * abdominal examination: to detect any abnormality as intrauterine growth restriction, with serial ultrasound estimation.

Eligibility criteria:
inclusion criteria: pregnant pt with covid 19 infection (at any gestational age) diagnosis of infection based on any one of the following criteria: 1. positive rt-pcr nasopharyngeal swab is taken (even if the result became available after labor); 2. positive rapid antigen test performed before labor 3. chest computed tomography (ct) scan performed before labor showing changes consistent with pneumonitis secondary to sars-cov-2 infection; 4. positive pre-labor immunoglobulin g or immunoglobulin m antibody test; or 5. clinical diagnosis made before labor (in the absence of negative rt-pcr swab results). exclusion criteria: 1. healthy individuals: 2. acute or chronic infectious disease, 3. and any medication with known influence on immunological factors.

Keywords: covid19 pneumonia feto-maternal infection covid 19 placental infection maternal mortality intrauterine fetal death
the effectiveness and safety of levosimendan in patients with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement

Conditions: Aortic Valve Stenosis; Heart Failure; Inotropic Agents; Safety Issues; Effect of Drug; Cardiac Event; Transcatheter Aortic Valve Replacement

Summary: a study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement

the number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. however, there is no specified study concentrated on the role of levosimendan in surgical procedure such as transcathter aortic intervention. this double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative levosimendan infusion.

Eligibility criteria:
inclusion criteria: 1. signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study 2. severe aortic stenosis 1. mean transaortic gradient ≥ 40 mmhg(at rest or stress) 2. aortic peak velocity ≥ 4m/s; 3. arotic valve area \<0.8 cm2 and/or aortic valve area index\< 0.5cm2/m2 3. cardiac dysfunction 1. lvef≤50% (estimated by simpson) 2. nt-probnp≥1500ng/l； 3. symptoms of dyspnea and fatigue when at rest or after slight exertion (new york heart association ≥ ⅲ -ⅳ) 4. intermittant fluid retention and/or symptoms induced by low cardiac output at rest, but lack of hemodynamic instability exclusion criteria: 1. decompensated acute cardiac failure due to hemodynamic instability 2. a historty of torsade de points ventricular tachycardia 3. known allergic reaction or sensitivity to levosimendan or excipients 4. received levosimendan within 1 week prior to the planned clinical trial 5. serum potassium \ 5.5 mmol/l before the drug study 6. systolic blood pressure \< 90mmhg at baseline 7. estimated glomerular filtration rate (egfr) ≤30 ml/min/1.73m2. 8. unable to participate in study for being critically ill asssed by clinicians 9. other concomitant severe morbidities leading to poor prognosis and decreased mortality, such as malignant tumor and disease involving other vital organs; life expectancy less than 1 year.

Keywords: aortic valve stenosis heart failure levosimendan transcatheter aortic valve replacement effectiveness safety nt-probnp