Kornimate/medical-research-clean huggingface dataset:
collection of plasma and serum samples from individuals initiating sofosbuvir for chronic hepatitis c for testing

Conditions: Hepatitis C

Summary: this non-interventional clinical study will be conducted to prospectively collect serial plasma and serum samples from treatment naïve subjects with chronic hcv infection who are initiating sofosbuvir-based therapy. these samples will be used to estimate clinical utility endpoints for the aptima hcv quant dx assay which is used an aid in the management of hcv-infected patients undergoing hcv antiviral therapy.


Eligibility criteria:
inclusion criteria: * the subject is chronically infected with hcv genotypes 1, 2, 3, 4, 5, and/or 6 as documented in the subject's medical records and is naïve to hcv treatment (treatment naïve). * chronic hcv (with or without hiv \[human immunodeficiency virus\] co-infection) will be documented with historical record of: * a positive hcv rna test result (result generated at least 6 months before the baseline visit) * a hcv genotype test result (result generated at least 6 months before the baseline visit) * a liver biopsy report demonstrating chronic hcv ---the subject is initiating antiviral therapy with a sofosbuvir regimen as indicated below: * sofosbuvir plus peginterferon and ribavirin for 12 weeks (peginterferon eligible genotype 1, 4, 5, or 6) * sofosbuvir plus ribavirin for 12 weeks (genotype 2) * sofosbuvir plus ribavirin for 24 weeks (peginterferon ineligible or unwilling genotype 1 or genotype 3) * the subject is at least 18 years of age at the time of enrollment * adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria * the subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s) exclusion criteria: * subjects with history or evidence of decompensated liver disease * subjects with severe renal impairment or end stage renal disease * subjects who are not naïve to hcv therapy with prior exposure to an approved or experimental hcv antiviral therapy * subject has characteristics that are contraindicated in the fda approved label for sofosbuvir (eg, subjects with contraindications applicable to peginterferon and/or ribavirin, pregnant woman or men whose female partners are pregnant; sovaldi package insert 2013) * subject is receiving treatment pre- or post-transplant * subject is unsuitable for study participation based on the investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication) * participating in another investigational study that the investigator believes might interfere with the subject's participation in this study
the effectivity and safety of favipiravir compared to oseltamivir as adjuvant therapy for covid-19

Conditions: Covid19

Summary: this study aims to analyze the effectiveness and safety of avigan® (favipiravir) compared to oseltamivir as an adjuvant therapy among adult covid-19 patients. this study will be conducted in a hospital setting, recruiting adult covid-19 patients with mild, moderate, and severe symptoms. subjects will be randomly given favipiravir or oseltamivir as an adjuvant therapy to standard covid-19 treatment. patients will be followed up for 21 days after the first dose of intervention given. the primary outcomes of this study are the improvement of radiology results and rt pcr negative conversion during follow up. the secondary outcomes are adverse events, hospital length of stay (los), and case fatality rate (cfr)

this open-label trial aims to analyze the effectiveness and safety of avigan® (favipiravir) compared to oseltamivir as an adjuvant therapy among adult covid-19 patients. this study will be conducted in a hospital setting, recruiting adult covid-19 patients with mild, moderate, and severe symptoms. subjects will be randomly given favipiravir or oseltamivir as an adjuvant therapy to standard covid-19 treatment. patients will be followed up for 21 days after the first dose of intervention given. the primary outcomes of this study are clinical improvements determined by laboratory measurements and radiology results. the secondary outcomes are adverse events, hospital length of stay (los), and case fatality rate (cfr)

Eligibility criteria:
inclusion criteria: 1. adult patients aged 18-75 years old 2. patients with covid-19 showing symptoms and confirmed with positive rt pcr test and or covid-19 igm/igg rapid test 3. no history of favipiravir or oseltamivir allergy 4. consented to participate in the trial. exclusion criteria: 1. pregnant women 2. breastfeeding mother 3. patients with markedly elevated liver enzyme (alt and/or ast) of more than three times from baseline level 4. reduced kidney function with estimated glomerular filtration rate (egfr) \ 2 mg/dl 5. patients with history of heart failure 6. tuberculosis infection that was treated with pyrazinamide 7. asthma that was treated with theophylline 8. type 2 diabetes that was treated with repaglinid

Keywords: covid-19 favipiravir oseltamivir adjuvant effectivity
a study for evaluation of immunogenicity and reactogenicity of fluarix™ / influsplit ssw® 2008/2009 in adults

Conditions: Influenza

Summary: this study is designed to test the immunogenicity and reactogenicity of the fluarix™/influsplit ssw® influenza vaccine containing the influenza strains recommended for the 2008-2009 season.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female aged 18 years or above at the time of the vaccination. * written informed consent obtained from the subject. * healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study. * if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. * administration of an influenza vaccine within 1 year preceding the study start. * administration of an influenza vaccine other than the study vaccine during the entire study * clinically or virologically confirmed influenza infection within 1 year preceding the study start * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * not stabilized or clinically serious chronic underlying disease. * lactating female. * history of chronic alcohol consumption and/or drug abuse. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * any condition which, in the opinion of the investigator, prevents the subject from participation in the study
fm-srp and tooth extraction improve type 2 diabetes mellitus in periodontitis

Conditions: Periodontitis; Type 2 Diabetes Mellitus

Summary: this intervention study is designed to evaluate the effects of non-surgical procedure in addition to surgical procedure on systemic inflammation and glycemic control in with type 2 diabetes mellitus patients with periodontitis in comparison with non-diabetic periodontic patients.

in a randomize, prospective study 200 patients from the endocrinology department of "peja's regional hospital" and dental polyclinic at city of peja, will be assessed and examined for eligibility. personal interviews will be used to collect the baseline data from each participant using a pre structured questionnaire. after clinical examination, 160 patients aged 30-70 years will be selected for the study. these will be further divided in four groups: type 2 diabetes mellitus group (with or without initial periodontal therapy) and non-diabetic group (with or without initial periodontal therapy). all the patients will be with periodontal disease and at least one tooth extraction will perform. previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (fm-srp) with ultrasonic device (uds-j ultrasonic scaler, guilin woodpecker medical instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus. post operative rinsing will be followed with antiseptic solution listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) as a mouthwash thrice a day for 3 weeks.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus; having a baseline hba1c ≥ 6.5%, at least 10 teeth in the functional dentition (excluding third molars) and a clinical diagnosis of periodontal disease with at least one site with probing depth (pd) ≥ 5mm, and two teeth with attachment lost ≥ 6mm and no modification in the pharmacological treatment of diabetes during the study period. exclusion criteria: * pregnancy or lactation, major diabetic complications, uses of antibiotic therapy or non-steroidal anti-inflammatory drug therapy 4 months before the first visit.

Keywords: diabetes oral hygiene periodontal surgery periodontal medicine
a non-interventional study of roactemra/actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis (monaco)

Conditions: Rheumatoid Arthritis

Summary: this multi-center observational study will evaluate the use of roactemra/actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. eligible patients initiated on roactemra/actemra treatment according to the licensed label will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis according to the revised (1987) acr criteria * patients in whom the treating physician has made the decision to commence roactemra/actemra treatment in monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) roactemra/actemra monotherapy treatment within 8 weeks prior to the enrolment visit. * concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (nsaids) are allowed exclusion criteria: * patients in whom roactemra/actemra is contraindicated according to the approved summary of product characteristics * patients who have received roactemra/actemra more than 8 weeks prior to the enrolment visit * patients who have previously received roactemra/actemra in a clinical trial or for compassionate use * concomitant dmard treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with roactemra/actemra * treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra * history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
reliability and validity of the isncsci in patients with non-traumatic spinal cord lesions

Conditions: Spinal Cord Injuries

Summary: aim of the study is to assess the psychometric properties of the international standards for neurological classification of spinal cord injury in subjects with non traumatic lesions.

all patients with non-traumatic sci consecutively admitted to three italian sci centers (irccs fondazione santa lucia, montecatone rehabilitation hospital and istituti clinici scientifici maugeri irccs of pavia) between january 1st 2017 and june 30th 2020 have been prospectively enrolled in the study.

Eligibility criteria:
inclusion criteria: * having a non-traumatic sci * acute / subacute phase * any level and severity (asia impairment scale) of injury * having a cognitive status that allows collaboration in the exam. exclusion criteria: * presence of dementia or cognitive decline; * having a pathology of the peripheral nervous system that may affect the evaluation of isncsci; * having a multiple sclerosis

Keywords: non traumatic spinal cord injury isncsci inter-rater reliability rehabilitation
patient reported outcomes investigation following initiation of drug therapy with entresto (sacubitril/valsartan) in heart failure

Conditions: Heart Failure, Systolic

Summary: real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via pros with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.

this is a prospective cohort study of 400 chronic hf patients that will also examine and describe retrospective electronic health record data. we will use the pcornet (patient centered outcomes research network, see "data sources" below) infrastructure to (1) identify a cohort of chronic systolic hf patients initiated on sacubitril/valsartan (n=200) as well as a comparator group of similar hf patients not initiated on sacubitril/valsartan (n=200) but with background ace/arb therapy and (2) evaluate baseline and follow-up pros via an electronic patient reported outcomes (epro) form in the ecos database for 12 weeks.

Eligibility criteria:
inclusion criteria * diagnosis of chronic systolic hf * active care by a provider in a healthcare system connected to a pcornet data partner * ability to speak and read english (given the use of the english epro technology) * newly initiating sacubitril/valsartan (observational sacubitril/valsartan treatment group only - within 1 week of first dose) * at least a 25% change ace/arb dose (including increase and decrease; or initiation or medication switching to another acei/arb) in the last 6 months (comparator group only) * reliable access to the internet exclusion criteria: * inability to provide informed consent * life expectancy \< 6 months * for comparator group patients: physician documentation of planned initiation of sacubitril/valsartan within 12 weeks other protocol inclusion/exclusion criteria may apply

Keywords: heart failure reduced left ventricular ejection fraction chronic systolic heart failure sacubitril /valsartan patient reported outcomes (pro) kansas city cardiomyopathy questionnaire (kccq) patient centered outcomes research network (pcornet) common data model (cdm)
study of diphereline 3.75 mg treatment in women suffering from internal genital endometriosis

Conditions: Internal Endometriosis

Summary: to describe gonadotropin-releasing hormone agonists (gnrh-a) treatment effectiveness on reduction of internal genital endometriosis symptom - menorrhagia - in different disease stages i, ii, iii in the russian patient population scheduled for treatment with diphereline 3,75 mg - assessment performed six months after the last injection.


Eligibility criteria:
inclusion criteria: * premenopausal women aged 25-40 years old * with symptomatic internal genital endometriosis - at least mild menorrhagia present or worse * internal genital endometriosis diagnosis is based on enlarged uterus detected by pelvic bimanual examination and ultrasound examination (stages i-ii-iii by demidov in accordance with ultrasound results not earlier than 2 months before first injection * naive patients who have never been prescribed a gnrh agonist exclusion criteria: * pregnant subjects * subjects with hypersensitivity to gnrh analogue or to one of its excipients * subjects treated with any other investigational drug within the last 30 days before study entry * subjects' refusal to participate in the study
a study of tq-b3525 tablets in subjects with pik3ca and/or pik3r1/2 gene-altered recurrent/metastatic advanced gynecologic tumors

Conditions: Advanced Endometrial Cancer, Cervical Cancer and Ovarian Cancer

Summary: this is a study to evaluate the efficacy and safety of tq-b3525 in subjects with recurrent / metastatic advanced endometrial cancer, cervical cancer and ovarian cancer with pik3ca and / or pik3r1 / 2 gene-altered (mutation or amplification). endometrial cancer, cervical cancer and ovarian cancer are divided into three cohorts, each cohort administrated tq-b3525 tablet orally once a day.


Eligibility criteria:
inclusion criteria: * 1. pathologically confirmed malignant gynecological neoplasm. 2. has pik3ca and/or pik3r1/2 gene-altered. 3.unresectable, locally advanced recurrent and/or metastatic tumors, has at least 1 measurable lesion. 4.failed with standard treatment or has no effective treatment. 5. 18 years and older, eastern cooperative oncology group(ecog) performance status score of 0 to 1, life expectancy ≥ 3 months. 6. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. 7.understood and signed an informed consent form. exclusion criteria: * 1.has untreated or active central nervous system metastases. 2.has diagnosed and/or treated additional malignancy within 3 years prior to the first administration. 3. insufficient hematopoietic function of bone marrow. 4. dysfunction of liver and kidney. 5. bleeding risk. 6. dysfunction of gastrointestinal tract. 7.dysfunction of heart and cerebral vessels. 8.has received pi3k, akt, mtor inhibitor. 9.has participated in other clinical trails within 30 days. 10. has received surgery, or unhealed wounds within 4 weeks before the first administration. 11. has received organ grafting, or hematopoietic stem cell transplantation within 60 days before the first administration, or host versus graft reaction. 12. the patients required immunosuppressor, or the whole-body, or absorbable local hormone therapy for immunosuppression purposes and continued to use within 7 days before the initial administration (daily dose of glucocorticoid \<10 mg, except metacortandracin or other therapeutic hormones and so on). 13. has active infections. 14. has human immunodeficiency virus (hiv). 15. pregnant or lactating women. 16. has psychotropic substances abuse or a mental disorder. 17. has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion. 18. patient's compliance is inadequate.
intralesional treatment of plantar wart

Conditions: Plantar Wart

Summary: group 1; intralesional injection of bleomycin in plantar wart. group 2; intralesional injection of 5-fluorouracil in plantar wart


Eligibility criteria:
inclusion criteria: subjects must meet all of the following criteria to be considered for participation in this study. 1. subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study. 2. male or female ≥ 8 years old. 3. subject has a clinical diagnosis of common warts. 4. subject has up to 1 target wart and up to 3 additional non-target warts located on the trunk or extremities. the identified target and non-target warts must meet the requirements as defined below: 1. each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm 2. each wart must be a discrete lesion 3. each wart must be present for at least 4 weeks 4. not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations 5. not be in an intertriginous fold 6. be the only common wart present when the circular cutout template is centered over the wart 5. the target and non-target warts must have a pwa ≥ 2. 6. subject chemistry and complete blood count results are within normal limits. if any of the laboratory values are outside normal range, the treating investigator must assess the value/s as not clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization. 7. woman of childbearing potential (wocbp) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study. 8. subject is non-pregnant and non-lactating. 9. subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any target or non-target warts or which exposes the subject to an unacceptable risk by study participation. 10. subject is willing and able to follow all study instructions and to attend all study visits. exclusion criteria: subjects are excluded from this study if any 1 or more of the following criteria is met: 1. subject has clinically atypical warts on the trunk or extremities. 2. subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant

Keywords: intralesional injection. bleomycin. 5-fluorouracil.