Kornimate/medical-research-clean huggingface dataset:
certolizumab pegol in subjects with active axial spondyloarthritis

Conditions: Spondyloarthropathies

Summary: the study is a phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of certolizumab pegol (czp) in subjects with active axial spondyloarthritis (axial spa).


Eligibility criteria:
inclusion criteria: * documented diagnosis of adult-onset axial spondyloarthritis (spa) of at least 3 months' duration as defined by the specified assessment of spondyloarthritis international society (asas) criteria * active disease as defined by: * bath ankylosing spondylitis disease activity index (basdai) score ≥ 4 * back pain ≥ 4 on a 0 to 10 neurobehavioral rating scale (nrs) (from basdai item 2) * c-reactive protein (crp) \> uln (upper limit of normal) and/or current evidence (ie, within the last 3 months from screening) for sacroiliitis on magnetic resonance imaging (mri) as defined by assessment of spondyloarthritis international society (asas) criteria * intolerance to or inadequate response to at least 1 nonsteroidal anti-inflammatory drug (nsaid) exclusion criteria: * presence of total spinal ankylosis ("bamboo spine") * diagnosis of any other inflammatory arthritis * prior treatment with any experimental biological agents for treatment of axial spondyloarthritis (spa) * exposure to more than 1 tnf-antagonist or to more than 2 previous biological agents for axial spondyloarthritis (spa) * history of or current chronic or recurrent infections * high risk of infection * recent live vaccination * concurrent malignancy or a history of malignancy * class iii or iv congestive heart failure - new york heart association (nyha) * demyelinating disease of the central nervous system * female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product * subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Keywords: certolizumab pegol cimzia
seroquel (quetiapine fumarate) inpractice evaluation programme

Conditions: Schizophrenia

Summary: patients eligible for entry into the study have a diagnosis of schizophrenia defined by diagnostic and statistical manual of mental disorders fourth edition (dsm-iv) criteria and of a chronic or sub-chronic nature.the primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with seroquel; additionally disease severity and treatment compliance are followed


Eligibility criteria:
inclusion criteria: * to assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the cgi scale * to assess the changes in symptoms of patients treated with seroquel for 24 weeks, using bprs (brief psychiatry rating scale) as measuring tool exclusion criteria: * all the patients who have a known hypersensitivity to seroquel /quetiapine or any of its excipients will not be included in this study.

Keywords: schizophrenia
transitional care model evaluation 2020

Conditions: CHF - Congestive Heart Failure; COPD; Pneumonia

Summary: the study is a randomized controlled trial to estimate the effects of the transitional care model (tcm) on hospital admissions and patients' experience during the year following the patient's qualifying discharge. the university of pennsylvania, where tcm was developed, will be the coordinating center for the implementation. the study will be conducted in three large health systems spread throughout the u.s., drawing patients from seven hospitals in those systems. eligible patients are older adults (age 65 and older) admitted to a participating hospital with symptoms of heart failure (hf), chronic obstructive pulmonary disease (copd), or pneumonia (pna). the evaluation will be conducted by mathematica.

the transitional care model (tcm) is an advanced practice registered nurse (aprn) led, team-based, care management strategy designed to improve the care and outcomes of high-risk older adults transitioning from hospital to home. eligible patients who agree to participate in the study will be randomly assigned to either the intervention group, which receives the tcm intervention, or the control group, which receives usual care (standard hospital discharge planning and post-hospital follow up services). the target sample size for the study is close to 1000, evenly divided into intervention and control groups, with 250 to 270 patients derived from each of ucsf and trinity health systems, and another 450 recruited from the two vha hospitals combined. data will be collected at intake, prior to randomization, by enrollment coordinators at each of the participating hospitals. followup data will be collected in a survey of patients conducted 90 days after discharge, and from claims data obtained from medicare, medicare advantage plans, and the vha.

Eligibility criteria:
inclusion criteria: * age 65 years and older * admitted from home with pneumonia or with a history of hf or copd with symptoms of hf or copd exacerbation or whose symptoms suggest a new hf or copd diagnosis * english and non-english speaking, able to respond to questions * reachable by telephone after discharge * resides within the geographic service area * consent to participation exclusion criteria: * enrolled in medicare's hospice or end-stage renal disease programs * presence of active and untreated psychiatric conditions (icd10: f10-f29) * long-term care resident * undergoing active cancer treatment * currently enrolled in another rct
oncological and functional outcomes in lower limb osteosarcoma pediatric patient

Conditions: Osteosarcoma; Pediatric; Lower Limb Injury; Outcome

Summary: retrospective analysis of specific characteristics of complications and long-term oncological and function outcomes in lower-limb osteosarcoma pediatric patients.

clinical and functional outcomes were compared based on age groups, surgical methods, type of prosthesis, and primary tumor location. patients were divided into the low-age group (≤10 years old) and the high-age group (\>10 years old). overall survival rate (os), progression-free survival rate (pfs), and prosthesis survival rate were assessed using kaplan-meier curves, and non-parametric survival analysis (log-rank test) was used for comparison. the incidence of complications, local relapse rate (lrr), metastasis rate, final limb-salvage and amputation rate, and musculoskeletal tumor society (msts) score of different independent groups were further evaluated using χ2 test or fisher's exact test, and t-test was employed to evaluate the measurement data.

Eligibility criteria:
inclusion criteria: 1. diagnosed lower limb osteosarcoma patients under the age of 14; 2. performing tumor resection treatment in our hospital; 3. there is complete clinical registration data available. exclusion criteria: 1. not undergoing surgical treatment in our hospital; 2. age older than 14 years old; 3. no available clinical registration data or lost follow-up patients; 4. non lower limb osteosarcoma patients.
bumetanide versus furosemide in heart failure

Conditions: Heart Failure

Summary: patients with nyha fc ii-iii heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. patients will be subject to a frequently sampled intravenous glucose tolerance test (fsigt) with minimal model (minmod) analysis to assess insulin resistance and to a 6-minute walk test (6mwt) to assess functional capacity; patient recruitment and retention success, as well as medication adherence, will also be assessed.

insulin resistance is common in patients with heart failure (hf) and is associated with a worse functional capacity and more severe symptoms of heart failure. the majority of hf patients take furosemide on at least a daily basis for symptom relief. bumetanide is a loop diuretic with a similar therapeutic diuretic effect to furosemide. there is evidence from observational and small comparative trials that bumetanide has a significantly less deleterious effect on indirect measures of insulin resistance compared with furosemide. however, a formal comparison between the 2 drugs using rigorous measures of insulin resistance has never been conducted in patients with hf. if bumetanide can be demonstrated to have a similar diuretic and a superior (less deleterious) effect on insulin resistance in patients with hf, the potential exists for bumetanide to have a significantly reduced morbidity in patients with heart failure compared to furosemide. in order to prepare for such a study, the variance of the minmod-derived insulin resistance from the fsigt (26), in this group of patient needs to be determined along with the feasibility of conducting such a study. functional capacity will be determined by duplicate 6-minute walk tests.

Eligibility criteria:
inclusion criteria: 1. men and women ≥18 years of age 2. nhya fc ii or iii hf and documented lvef ≤40% within 6 months prior to study entry 3. taking 20 mg to 80 mg furosemide orally once or twice per day 4. no changes to cardiac medications for 3 months prior to study entry and no anticipated changes of medications for the duration of the study 5. no changes to oral anti-diabetic medications (if applicable) for 3 months prior to study entry, and no anticipated changes for the duration of the study (metformin, sulphonylurea type, glitazone type) 6. ability to provide written consent exclusion criteria: 1. known sensitivity to bumetanide 2. myocardial infarction, coronary angioplasty, coronary artery bypass surgery, admission for hf or unstable angina within a 3 month period prior to study recruitment 3. planned coronary intervention within 6 months 4. patients who are taking insulin 5. patients with chronic renal (serum creatinine ≥ 200 μmol/l) or hepatic impairment (known cirrhosis or ast or alt \> 1.5 x upper limit of normal)

Keywords: insulin resistance heart failure diuretic therapy
a practical nomogram based on systemic inflammatory markers for predicting portal vein thrombosis in patients with liver cirrhosis

Conditions: Systemic Inflammatory Markers; Portal Vein Thrombosis

Summary: immunothrombosis has recently been used to describe the responses/mechanisms in thrombosis. systemic inflammatory markers are prognostic markers for a variety of thrombotic conditions; however, their potential value in predicting portal vein thrombosis (pvt) is unknown. this study aimed to establish an easy-to-use nomogram based on systemic inflammatory markers to predict portal vein thrombosis (pvt) in patients with liver cirrhosis.

this retrospective study included 478 patients with cirrhosis between january 2013 and january 2021. reputed systemic inflammatory markers (systemic immune-inflammation index \[sii\], neutrophil-to-lymphocyte ratio \[nlr\], monocyte-to-lymphocyte ratio \[mlr\], and platelet-to-lymphocyte ratio (plr)) were measured, and the clinical data were recorded. the independent risk factors for pvt were determined using univariate analyses and multivariate logistic regression analyses, and a nomogram to predict the occurrence of pvt was established. the concordance index, receiver operating characteristic curves, and calibration plots were used to evaluate the performance of the model.

Eligibility criteria:
inclusion criteria:the diagnosis of lc was based on clinical, laboratory, and radiological analyses, and/or liver biopsies. pvt was diagnosed according to the consensus for management of pvt in lc (2020, shanghai) \[1\]. the inclusion criteria were as follows: (i) age ≥18 years, (ii) doppler ultrasound was the first-choice imaging modality; however, enhanced computed tomography or magnetic resonance imaging could also be used for confirmation at the time of admission to our hospital, and (iii) patients with pvt on imaging examination but with insufficient evidence for the diagnosis of cirrhosis, hepatic vein pressure gradient measurement, and liver biopsy. - exclusion criteria:patients with primary or secondary hepatic malignant tumors, other malignant tumors, hematologic diseases, budd-chiari syndrome, non-cirrhotic pvt, inflammatory diseases, and other severe diseases were excluded. -

Keywords: portal vein thrombosis systemic inflammatory markers
comparison of the effect of propacetamol, ibuprofen or their combination on postoperative pain and quality of recovery after laparoscopic hernia repair in children

Conditions: Inguinal Hernia

Summary: there are difficulties in the progress of the study and cancel the plan. the purpose of this study is to evaluate the postoperative pain control using non - opioidal analgesics in children. the investigators will investigate the effect of single use and combination of caldorol(ibuprofen) compare to denogan(propacetamol) in children. participants who receive the laparoscopic inguinal hernia repair between 6 months and 6 years old are divided 3 groups(caldolor, denogan, combination). each groups are received a medication by protocol during surgery. after operation patient's pain score and use of additional analgesics are recorded in postanesthesia care unit and general ward.


Eligibility criteria:
inclusion criteria: * scheduled to undergo laparoscopic inguinal hernia surgery * american society of anesthesiologists physical status classification 1 or 2 * children aged 6 months to 6 years exclusion criteria: * history of gastrointestinal bleeding * history or laboratory finding of suspected renal or hepatic dysfunction * bronchial asthma * bleeding disorder * hypersensitivity to nsaid or propacetamol * disagreement of investigation * the researcher determines that participation is inappropriate due to other reasons.
a safety and tolerability study of jnj-42160443 in patients with moderate to severe, chronic knee pain from osteoarthritis

Conditions: Osteoarthritis; Osteoarthritis, Knee; Pain; Arthralgia; Joint Pain

Summary: the purpose of this study is to evaluate pain relief, safety, and tolerability of a new treatment (jnj-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo.

this is a double-blind (neither the physician nor the patient knows the name of the assigned drug) study evaluating pain relief, safety, and tolerability of a new treatment (jnj-42160443) for moderate to severe pain of osteoarthritis of the knee in comparison to a standard pain treatment and placebo. the study will last for about 42 weeks. patients will receive treatment for 16 weeks. patients who qualify for the study based on their level of pain as well as other factors will receive one of the 4 possible treatments as determined by chance. before entering the study, patients must stop using their present pain medication. during the study, patients will answer questions about their pain, side effects, and have tests performed to monitor their physical condition. the main purpose of the study is to compare pain relief with jnj-42160443 to that of a standard pain treatment or placebo. after the treatment period, patients can return to taking the pain medication that they used before the start of the study, and their physical condition will continue to be monitored. jnj 42160443 10 mg/ml will be provided for use in the study. patients will receive 1 of 4 treatments for 16 weeks (wks): lower dosage of jnj 42160443 by subcutaneous (under the skin) (sc) injection once every 4 wks + placebo (p) capsule orally (by mouth) (po) 2x/day, higher dosage of jnj 42160443 by sc injection once every 4 wks + p capsule po 2x/day, standard pain medication capsule po 2x/day + p by sc injection once every 4 wks, or p capsule po 2x/day + p by sc injection once every 4 wks.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of osteoarthritis of the knee * have moderate to severe pain based on a trial questionnaire * must be on a stable dose of pain medication for 4 weeks before entering the trial * medically stable condition exclusion criteria: * history of joint replacement surgery in the affected joint or planned surgery involving the affected joint during the trial * diabetes mellitus * uncontrolled cardiovascular disease or hypertension * previous treatment with another investigational ngf inhibitor therapy

Keywords: osteoarthritis pain of the knee osteoarthritis osteoarthritis, knee pain arthralgia joint pain jnj-42160443
human sodium balance study

Conditions: Hypertension

Summary: the overall objective of this study is to examine how dietary sodium is used by the body. in a racially diverse sample of adults, the investigators will examine the effects of high and low dietary sodium intake on the storage and excretion of sodium and determine whether sodium distribution affects blood pressure. this has implications for how investigators interpret studies that use urine biomarkers of sodium. study findings about tissue sodium storage also have implications for managing hypertension and related conditions.


Eligibility criteria:
inclusion criteria: * at least 18 years old; * diagnosed with high blood pressure or pre-hypertension (systolic blood pressure (sbp) \> 120 mm hg or diastolic blood pressure (dbp) \> 80 mm hg); * taking no more than two medications for high blood pressure; * currently has a primary care provider; * willing to eat all meals provided by the study for two 14-day feeding periods; * willing to complete study measurement procedures. exclusion criteria: * diabetes; * smoker; * serious food allergies; * currently pregnant or planning to become pregnant

Keywords: blood pressure sodium salt randomized controlled trial balance humans
dapansutrile in diabetes and diabetes-related complications - dapan-dia

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to determine whether nlrp3 inhibition with dapansutrile represents a new pharmacological option for diabetes management with potential as an anti-inflammatory agent to also address micro- and macro-vascular risk and complications from diabetes.

to date, no other oral nlrp3 inhibitor has sufficiently advanced in development to be tested in a chronic low-grade inflammatory disease such as type 2 diabetes mellitus over a period of 3 to 4 months as proposed in this trial. based on the publicly available information, dapansutrile is the most advanced oral nlrp3 inhibitor in development. the rationale is built upon dapansutrile's clinical and extensive preclinical and safety findings, and from data in chronic animal toxicology studies to date, which together enable and support its investigation in select chronic low-grade inflammatory diseases. therefore, the investigators have selected type 2 diabetes mellitus and its complications, including risk for cardiovascular disease, as a disease with clinical features of low-grade inflammation to further investigate the therapeutic potential of nlrp3 inhibition with dapansutrile.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2, diabetes mellitus as defined by the criteria of the american diabetes association (ada) expert committee on the diagnosis and classification of diabetes mellitus (see appendix 1) and recognized by the world health organization (who, 2019), for at least 3 months prior to the baseline visit/day 1 * hba1c value of ≥ 7.7% to ≤ 11.0% at the screening visit. * high-sensitivity c-reactive protein (hscrp) ≥ 1.5 mg/l at the screening visit. * body mass index (bmi) ≥18 to ≤ 40 kg/m2 at the screening visit * acceptable overall medical condition to safely participate in the study and complete all study procedures (particularly with regard to cardiovascular, renal, and hepatic conditions), in the opinion of the investigator exclusion criteria: * diagnosis of type 1 diabetes mellitus * hba1c value of ≤ 7.5% or ≥ 10.5% at the baseline visit/day 1, as determined at point of care (local laboratory) * use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin/insulin analogues (as bolus or premixed insulin) within 12 weeks prior to the screening visit * less than 80% compliance in taking investigational medicinal product by pill count during the run-in period, as assessed at the baseline visit/day 1 * significant weight loss (\> 5 kg) in the 12 weeks prior to the screening visit * systolic blood pressure (bp) ≥ 160 mmhg, diastolic bp ≥ 100 mmhg, or resting heart rate (hr) ≥ 100 beats/minute at the screening visit * previous myocardial infarction, any cardiac surgery
the short-term effects of simvastatin on the vision of males affected by choroideremia

Conditions: Choroideremia

Summary: primary objective: to examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. the investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study * male * diagnosed with choroideremia and in good health * willing to allow his general practitioner and consultant, if appropriate, to be notified of participation in the study * over age of 18 years exclusion criteria: * female * significant health disease, disorder, or medication, which, in the opinion of the investigator, would put the patient at risk if he were to take simvastatin * already taking simvastatin or another statin