Kornimate/medical-research-clean huggingface dataset:
therapy management in patients treated with anakinra due to recurrent pericarditis

Conditions: Recurrent Pericarditis

Summary: to determine the utility of serial cardiac magnetic resonance (cmr) imaging for guidance of therapy management in patients treated with anakinra due to recurrent pericarditis (rp), compared with c-reactive protein (crp) assay alone.

recurrent pericarditis (rp) is a specific pathology of the pericardium included within the pericardial syndromes by the guidelines of the european society of cardiology (esc). the latter defines rp as pericarditis occurring after a symptom-free interval of 4-6 weeks from a documented first episode of acute pericarditis; the recurrences rate may range from 15 to 30%, with a significant increment of 50% in patients treated with corticosteroids or not treated with colchicine. the diagnosis of recurrences follows the same criteria utilized for acute pericarditis, and a viral etiology can often be demonstrated. the pathogenesis of rp is still debated, but they are self-sustained by an autoinflammatory/ autoimmune amplified response following an exogenous or endogenous trigger. in this context, the cytokine interleukin 1 (il-1) has been implicated as a key mediator of rp. anakinra, an il-1 antagonist, is of particular interest because it limits the self-sustained pathway of rp and may reduce the recurrences. the current 2015 esc guidelines for the diagnosis and management of pericardial diseases recommend anakinra in cases of proven infection-negative, corticosteroid-dependent rp not responsive to colchicine, but it remains debated the duration of the therapy and when to start its tapering. in this context, cardiac magnetic resonance (cmr) imaging has recently emerged as an interesting imaging biomarker capable of detecting pericardial inflammation, proving pericardial edema and late gadolinium enhancement (lge), and distinguishing three defined pericardial inflammation phases: acute (edema and lge), subacute (only lge) and burned-out (no edema nor lge). to overcome the 2015 esc guidelines limitations, the investigators sought to determine the utility of serial cmr imaging for guidance of therapy management in patients treated with anakinra due to rp, compared with the c-reactive protein (crp) assay alone, as currently recommended.

Eligibility criteria:
inclusion criteria: * adult patients treated with anakinra 100 mg/die if ≥ 18 years old, and * pediatric patients treated with anakinra 2 mg/kg/die if \< 18 years old * pediatric and adult patients treated with anakinra due to corticosteroid-dependent or not responsive to colchicine or non-steroidal anti-inflammatory drugs (nsaids) recurrent pericarditis exclusion criteria: * ongoing infection (proved within serology) * refuse to participate in the trial

Keywords: anakinra cardiac magnetic resonance late gadolinium enhancement c-reactive protein
gastroenterology artificial intelligence system for detecting colorectal polyps (the gain study)

Conditions: Colon Adenoma; Colon Polyp; Colon Lesion

Summary: this is a prospective, multicenter, randomized controlled study to evaluate the effect of the computer-assisted detection (cade) device on adenomas per colonoscopy and positive percent agreement for routine colonoscopies. the control arm is colonoscopy performed with high definition white light endoscopy (hd-wle) per standard of care. the intervention arm is colonoscopy performed with hd-wle per standard of care plus the computer-assisted detection (cade) device.


Eligibility criteria:
inclusion criteria: * scheduled to undergo routine screening (including, but not limited to, fit/cologuard positive), routine surveillance (≥3 years as scheduled since last colonoscopy), or diagnostic (symptomatic) colonoscopy with high definition white light endoscopy. * between the ages of 45 and 80 years, inclusive * able and willing to provide written informed consent exclusion criteria: * self-reported pregnancy * known diagnosis of colorectal cancer * history of, or referral for, inflammatory bowel disease * previous surgery involving the colon or rectum * referral for known polyp or assessment of post-polypectomy site (i.e. less than 3 years since last colonoscopy). * high suspicion or diagnosis of genetic polyposis syndromes, including familial adenomatous polyposis (fap), hereditary nonpolyposis colorectal cancer (hnpcc), or any other high-risk family history meeting bethesda guidelines. * referral for overt, symptomatic gastrointestinal bleeding
vitamin d supplementation in vitamin deficient women undergoing ivf cycles: does it affect the fertility outcome?

Conditions: Infertility

Summary: the aim of this study is to evaluate the effect of treatment of vitamin d deficiency (through vitamin d supplementation for 8 weeks before the start of in-vitro fertilization (ivf) on the success of ivf cycles.

the study participants are vitamin d deficient females undergoing (intra-cytoplasmic sperm injection (icsi) trial in the age of 20 to 35 years. serum vitamin d will be assessed. accordingly, if they are deficient in vitamin d, they will be eligible for the study.400 vitamin d deficient women will be randomly allocated to either one of two groups. the first group will receive vitamin d supplementation in addition to the routine care. the other group will receive the routine care only. the study will be conducted in the ivf unit of department of obstetrics and gynecology, cairo university.

Eligibility criteria:
inclusion criteria: * vitamin d deficient females undergoing first icsi trial * age from 20 to 35 years exclusion criteria: * women undergoing icsi trials who are vitamin d sufficient
a retrospective study to assess the impact of the use of interferon in patients with chronic hepatitis c (decision)

Conditions: Hepatitis C, Chronic

Summary: this retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis c. data will be collected for 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years and \<70 years of age * diagnosis of hepatitis c * assessment of viral load prior to treatment (mandatory for genotype 1 only) * liver biopsy * co-morbidities data * use of interferon (pegylated or conventional) and ribavirin to treat hepatitis c infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis c infection genotype 1 * above mentioned treatment started between 01-sep-2007 and 31-aug-2008 exclusion criteria: * co-infection with human immunodeficiency virus * co-infection with hepatitis b virus * presence of hepatocarcinoma * patients submitted to hemodialysis * organ transplant patients
investigation of a sub-conjunctival insert

Conditions: Diabetes Care

Summary: the study is intended to evaluate a non-invasive method of glucose measurement in diabetics. the medical device that is evaluated consists on a sensor-insert which is placed under the conjunctiva of the eye of diabetic patients and a photometer. the goal is to prove that the sensor signal correlates with the blood glucose of the patients determined by standard laboratory blood glucose measurement.


Eligibility criteria:
inclusion criteria: * be of legal age * insulin dependent diabetes requiring daily finger pricking to monitor blood glucose * sign written informed consent exclusion criteria: * inability to follow the protocol schedule * participating in another clinical study * pregnant or lactating females * any ongoing condition that would prevent from proper handling of the instrument (e.g. blindness, strong impaired vision, impaired motor skills) * any known hypersensitivity to any of the products to be used in the study, including preservatives etc. * malignancies requiring therapy during the study * severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study * poorly controlled diabetes mellitus with prior hemoglobin a1c greater than 10% * any ocular disease requiring topical medication besides those permitted by this protocol. * ocular or other condition which increase the risk of ocular surgery, e.g. acute or chronic conjunctivitis or blepharitis, corneal disorders, previous eye surgery or eye surgery within the following 12 weeks, coagulation disorders.

Keywords: medical device, sub-conjunctival insert photometer fluorescence subconjunctival interstitial fluid glucose non-invasive measurement
treatment of refractory adult-onset still's disease with anakinra: a randomized study

Conditions: Adult-Onset Still's Disease

Summary: an open, randomized, parallel-group, comparative, multicentre study. patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin a or sulphasalazine. patients enter the study if considered refractory to corticosteroids (prednisolone equivalent ≥10 mg/day) at the time of randomization. the randomized phase of the study will be followed by an open-label extension (ole) phase, to follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment with anakinra or one of the study dmards or a combination of study drugs for additional 28 weeks.

product: kineret (anakinra) comparative agents: methotrexate or azathioprine or leflunomide or cyclosporin a or sulphasalazine protocol title: an open, randomized study treating refractory adult-onset still's disease with il-1ra anakinra (kineret, compared to an established, single anti-rheumatic treatment target disease: adult-onset still's disease patients: 23 patients diagnosed with aosd, living in the four nordic countries. study objectives: to follow the changes in clinical status and disease activity in patients receiving anakinra, compared to those treated with an established dmard, in addition to corticosteroids in patients with refractory aosd. to compare the changes in disease-related parameters (global health, patient's assessment on disease, laboratory values) in the two randomized groups. to assess the safety of anakinra in aosd. to follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment in aosd (open phase).

Eligibility criteria:
inclusion criteria: * must be diagnosed with aosd according to preliminary classification by yamaguchi (1992). * other diseases with similar symptoms must be excluded. has been exposed to a corticosteroid for ≥2 months prior to randomization for aosd. * needs a prednisolone dose ≥10 mg/day or equivalent, yet unacceptable disease activity determined by the investigator. * anti-tnf agents must be discontinued 4 to 8 weeks prior to commencing study medication. exclusion criteria: * use of corticosteroids (prednisolone equivalent \<10 mg/day. * history of recurrent or chronic infection, including: * tuberculosis * any malignancy * any other major chronic inflammatory disease syndrome * drug or alcohol abuse * known positivity for hepatitis b, c or hiv. * use of anti-tnf agents during ≤4 weeks (etanercept) or≤8 weeks (infliximab or adalimumab) prior to randomization.

Keywords: adult-onset still's disease anakinra prednisolone disease-modifying antirheumatic drug methotrexate efficacy patients
swallowing sound in preterm infant evaluation of feeding maturation

Conditions: Other Preterm Infants

Summary: our objective was to evaluate maturation of sucking and swallowing in preterm infants using a non-invasive method: assessment of swallowing sounds. findings in healthy term infants were used as reference values.

successful transition to full oral feeding in preterm infants is important for safe discharge from hospital and for facilitating the mother-infant bond. preterm infants were evaluated weekly for sucking and swallowing performance (i.e., feeding performance) from the time they began oral feeding (frequency 1-2 oral feedings/day) until they reached independent oral feeding (frequency 8 oral feedings/day) at postmenstrual 38-40 weeks. for the term infants, we evaluated a single oral feeding during the first week of life. the exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis. each swallowing-sound recording was 2 minutes long and was captured in a quiet environment by the same investigator. the feeding parameters generated from the recordings were as follows: total number of swallows (s), total number of rhythmic swallows (rs), total number of resting intervals (ri), average time between resting intervals (atri), average time between swallows (ats), average time between rhythmic swallows (atrs), maximum number of rythymic swallows (mrs), and volume of milk ingested (vm) during the 2-minute evaluation.

Eligibility criteria:
inclusion criteria: * preterm infants (\ =37 gestational weeks) exclusion criteria: - the exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis.

Keywords: maturation preterm infants sucking and swallowing
safety and tolerability of nv1fgf in patients with severe peripheral artery occlusive disease

Conditions: Peripheral Arterial Occlusive Disease

Summary: the primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of nv1fgf administered intramuscularly in patients with severe peripheral artery occlusive disease (paod), (rutherford's grade ii, category 4 or grade iii, category 5 and 6). secondary objectives are: * to determine the biological activity of nv1fgf on collateral artery development. * to evaluate the activity of nv1fgf on hemodynamic and clinical parameters.

screening period of 30 days before dosing. patients receive a single administration or repeated (2) administrations (with a 2-week interval) of nv1fgf. patients are then followed for a period of 6 months

Eligibility criteria:
inclusion criteria: * severe paod defined as rutherford's grade ii, category 4 or grade iii, category 5 and 6 * pain at rest for at least 2 weeks duration and/or trophic lesions for at least the previous 14 days with no signs of healing (no reduction in ulcer size or depth) * objective evidence of peripheral vascular disease (resting ankle brachial index \< 0.4 and/or resting toe brachial index \< 0.3 and/or metatarsal peripheral vascular resistance flat or barely pulsatile in the diseased limb on 2 consecutive examinations performed at least 2 weeks apart) * angiographic demonstration of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries * poor candidate for surgical intervention or revascularization procedures (no tibial artery incontinuity as defined from mid-leg distance from the foot and no autologous tissue available) exclusion criteria : * previous or current history of malignant disease. patients who had successful tumor resection more than 10 years prior to inclusion into the study and had no recurrence and patients who had curatively resected basal/squamous cancer of the skin were allowed for inclusion * abnormal chest x-ray with suspected malignant tumor presence * positive stool hemoccult (expect if due to hemorrhoids) * positive prostate specific antigen for men with suspected malignant tumor presence * abnormal mammography for women with suspected malignant tumor presence * papanicolaou smear (for women) of class iv or class v characterization * proliferative retinopathy the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
teach-back educational method on diabetes knowledge level

Conditions: Patient Empowerment

Summary: it was aimed to research the effect of teach-back educational method on diabetes knowledge level and clinical parameters in type 2 diabetes patients undergoing insulin therapy. this is a randomized-controlled trial. teach-back method will used for intervention group, routin diabetes education will used for control group. the primary outcome is diabetes knowledge levels (dkl), and secondary outcome is clinical patameters (fasting blood glucose, hba1c, blood pressure). dkl and clinical parameters will measured and compared between two groups before and three months after the interventions.


Eligibility criteria:
inclusion criteria: * to have type 2 diabetes * to be over 18 years old * not have any barriers in understanding and speaking turkish * who started insulin treatment for the first time exclusion criteria: * patients with a diagnosis of dementia * to have vision or hearing loss

Keywords: diabetes education teach-back
local potential measurement in pfa: a pilot study

Conditions: Atrial Fibrillation (AF)

Summary: this is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.


Eligibility criteria:
inclusion criteria: * subjects with paroxysmal or persistent atrial fibrillation (af) undergoing first time pfa procedure indicated by investigator for the treatment of atrial fibrillation. male or non-pregnant female aged ≥18 years. able and willing to provide written informed consent prior to any clinical investigation related procedure exclusion criteria: * pregnant or nursing subjects. * current participation in another investigational drug or device study that interferes with this study. * subjects who, in the opinion of the investigator, are not candidates for this study. * patients who have had a prior ablation procedure * presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. * life expectancy is less than 12 months, in the opinion of the investigator * subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
a study of sbt6050 alone and in combination with pd-1 inhibitors in subjects with advanced her2 expressing solid tumors

Conditions: HER2 Positive Solid Tumors

Summary: a first-in-human (fih) study using sbt6050 and sbt6050 in combination with pd-1 inhibitors in her2 expressing or amplified advanced malignancies

this study has 5 parts. part 1 will evaluate the safety, tolerability, and activity of escalating doses of sbt6050 to estimate the maximum tolerated dose (mtd) and determine the dose recommended for part 2. part 2 of the study will further evaluate sbt6050 in select her2 expressing or amplified advanced malignancies. part 3 will evaluate the safety, tolerability, and activity of escalating doses of sbt6050 in combination with pembrolizumab to estimate the mtd and determine the dose recommended for part 4. part 4 of the study will further evaluate sbt6050 in combination with pembrolizumab in select her2 expressing or amplified advanced malignancies. part 5 of the study will evaluate the safety, tolerability, and activity of sbt6050 in combination with cemiplimab in select her2 expressing or amplified advanced malignancies.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic her2-expressing (ihc 2+ or 3+) or amplified solid tumor * subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive) * measurable disease per recist 1.1 * tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic, hepatic, and cardiac function exclusion criteria: * history of allergic reactions to certain components of sbt6050 or similar drugs * untreated brain metastases * active autoimmune disease or a documented history of autoimmune disease or syndrome * human immunodeficiency virus infection, active hepatitis b infection or hepatitis c infection * additional protocol defined inclusion/exclusion criteria may apply.

Keywords: her2 erbb2 immunotherapy gastric cancer gastroesophageal junction breast cancer triple negative breast cancer stomach cancer colorectal cancer gastrointestinal cancer non-small cell lung cancer monoclonal antibody tlr8 tlr8 agonist antibody drug conjugate biliary tract cancer head and neck cancer urothelial cancer endometrial cancer pembrolizumab anti-pd-1 mab cemiplimab
mk0767 in type 2 diabetes (0767-012)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a clinical trial in patients with type 2 diabetes to test the safety of mk0767. this study will also see how effective mk0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-hdl cholesterol when compared with placebo and pioglitazone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients between the ages of 21 and 75 inclusive * patient is willing to discontinue current therapy for the duration of the study * patient is not a heavy drinker exclusion criteria: * patient has a history of type 1 diabetes and/or ketoacidosis * patient has severe diabetic retinopathy, or nephropathy, or neuropath * patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1 * patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments
closed-loop oxygen to verify that healthcare workers interventions decrease during sars-cov-2 pneumonia (covid-19)

Conditions: Coronavirus; Pneumonia; Oxygen Toxicity

Summary: there is a high risk of transmission of covid-19 to healthcare workers. in a recent cohort, 29% of the patients hospitalized were healthcare workers. among the who's primary strategic objectives for the response to covid-19, the first was to limit human-to-human transmission, including reducing secondary infections among close contacts and health care workers. automated oxygen titration, weaning and monitoring (freeo2 device) may be a solution to reduce the number of interventions of healthcare workers related to oxygen therapy, to reduce complications related to oxygen and to improve monitoring.


Eligibility criteria:
inclusion criteria: * age\> 18 years old * patients with acute respiratory failure related to suspected community acquired pneumonia (viral and non viral) requiring oxygen therapy \< 6 l/min (or fio2\< 0.50) (to maintain spo2 between 90 and 94% spo2) without criteria for immediate intubation or icu transfer. * patients hospital admission \< 72 hours exclusion criteria: * shock state, * no spo2 signal available, * patient agitation, * ph \< 7.30 (if blood gas available) * paco2 \> 50 mmhg, (if blood gas available) or chronic hypercapnia history * non invasive respiratory support (niv, high flow nasal therapy (hfnt)) at study inclusion * withdrawal of life support or palliation as the goal of care * patients' or next of kin refusal to participate to the study