Kornimate/medical-research-clean huggingface dataset:
study to assess the safety and efficacy of etanercept in patients treated over the long-term in real-world clinical practice, using data collected by the british society of rheumatology biologics registry

Conditions: Rheumatoid Arthritis

Summary: this study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. it will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (dmards). the study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.

patients recruited sequentially as seen in clinical practice

Eligibility criteria:
inclusion criteria: * adult * rheumatoid arthritis * group 1: initiating etanercept as first biologic therapy * group 2: das28\<4.2, biologic naive and treated with non-biologic dmards exclusion criteria: * diagnosis of other inflammatory arthritis

Keywords: observational non-interventional cohort retrospective register rheumatoid arthritis
a phase 3 study of asp1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis

Conditions: Chronic Kidney Disease; Renal Insufficiency; Hyperphosphatemia

Summary: this is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of asp1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patients (egfr \< 60 ml/min/1.73 m2) * serum phosphorus measurement ≧4.6 mg/dl, \<9.0 mg/dl * written informed consent exclusion criteria: * patients with gastrointestinal surgery or enterectomy * patients with severe cardiac diseases * patients with severe constipation or diarrhea * patients with a history or complication of malignant tumors * patients with uncontrolled hypertension * patients treated with parathyroid intervention within 6 months

Keywords: ckd not on dialysis asp1585 bixalomer
metabolic effects of gastrointestinal surgery in t2dm

Conditions: Type 2 Diabetes

Summary: gastric bypass surgery resolves type 2 diabetes mellitus (t2dm) without the need for diabetes therapy in \~80% of patients. moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. this observation has led to the notion that bypassing the upper gastrointestinal (gi) tract has specific therapeutic effects on insulin action and glucose metabolism. in fact, both surgical and endoscopic procedures that bypass the upper gi tract are currently being studied in human subjects. recently, a new surgical technique, duodenal-jejunal bypass surgery (djbs), has been developed specifically to treat t2dm. data from preliminary studies have shown that djbs results in glycemic control in 87% of overweight and obese patients with t2dm.these subjects will undergo metabolic studies at the university hospital in sao paulo before and after their surgical procedure. washington university investigators will: 1) provide technical support and guidance to the physicians performing the studies in brazil, 2) process and analyze blood samples obtained from the study at the washington university center for human nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. the effects of djbs on the following clinical and metabolic parameters will be evaluated


Eligibility criteria:
inclusion criteria: * uncontrolled diabetes ( a1c\>8%) * less than 10 years of history * not taking insulin * ages between 20 and 65 years old * bmi between 26-34 exclusion criteria: * previous abdominal surgery * lada * using insulin

Keywords: diabetes metabolic surgery insulin resistance
the uncommon complications of meckel's diverticulum

Conditions: To Report the Rare Occurrence of Meckel's Diverticulum

Summary: acas series study was conducted on emergency acute abdomen patients who finally confirmed intraoperatively as meckel's diverticulum with different complications. simple perforation to isolated axial torsioned gangrene was observed. the patients signed consent for their cases to be published.

the study was aimed at reporting the rare complications of meckel's diverticulum, which were diagnosed intraoperatively among acute abdomen patients presented to hfcsh. the patients had different complications ranging from simple isolated perforation to gangrenous meckel's diverticulum. all of the patients gave their informed written and signed consent for publication.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with complicated meckel's diverticulum exclusion criteria: * patients who didn't consent

Keywords: meckel's diverticulum; isolated torsion; intussusception; acute abdomen; acute appendicitis
clinical impact of white tea and wheat grass on color enhancement of white spot lesions

Conditions: White Spot Lesions [Initial Caries] on Smooth Surface of Tooth

Summary: the current study aimed to evaluate the color change potential of wheat grass and white tea on post orthodontic white spot lesions (wsls). materials and methods: a total of 12 patients were divided into two main groups a1 and a2 according to type of treatment agent (n=6). the a1 group used 10% white tea solution while the a2 group used 10% wheat grass solution. shade evaluation was conducted using vita easyshade v spectrophotometer. baseline l a b values of wsls were detected right after orthodontic bracket removal. patients were requested to rinse with the treatment agent for 1 minute, twice per day. the mean l,a,b values were recorded after 1 month and after 3 months . δe values were calculated between baseline, 1 month and 3 months after the treatment agent application and subjected to statistical analysis using one way anova with p\&gt;0.05. also, standardized photographs were taken at baseline, after 1 and 3 months. each wsl was photographed twice with the 1st photograph taken of wet teeth and the 2nd one after prolonged air-drying in order to perform icdas ii scoring.


Eligibility criteria:
inclusion criteria: 1. age range between 15-18 years. 2. good oral hygiene 3. obvious area of wsl was found around the fixed orthodontic brackets. 4. included teeth should be free of any restorations exclusion criteria: - : 1. cavitated enamel surface. 2. presence of any restorations including the labial surface of the involved teeth. 3. presence of any environmental or developmental enamel defect such as enamel hypoplasia, fluorosis, stains, and trauma sites on teeth before orthodontic treatment. 4. allergy to tea and/or wheat
peri-appendiceal abscess and phlegmon in acute complicated appendicitis patients

Conditions: Acute Complicated Appendicitis With Peri-appendiceal Abscess or Phlegmon

Summary: this study aim to analyze the clinical data of patients who underwent emergency appendectomy for acute complicated appendicitis with peri-appendiceal abscess or phlegmon, identify factors influencing the post-operative length of hospital stay (los), and improve treatment strategies.

appendicitis is defined as inflammation of the vermiform appendix and worldwide is the most common reason for emergency abdominal surgery. globally, the annual incidence is 96.5 to 100 cases per 100 000 adult population. for acute uncomplicated appendicitis, antibiotic therapy has emerged as the primary treatment, often allowing patients to avoid surgery. however, the management of acute complicated appendicitis requires careful consideration of various treatment options. complicated appendicitis, characterized by peri-appendiceal phlegmon or abscess formation, presents additional challenges and often requires a more comprehensive treatment approach. management strategies have evolved to incorporate both conservative and surgical treatments, tailored to the patient's condition. typically, for early-stage appendicitis (duration of symptoms ≤72 hours) with peri-appendiceal phlegmon, surgical treatment is recommended, while late-stage appendicitis (duration of symptoms \>72 hours) or cases with peri-appendiceal abscess formation are initially managed conservatively with percutaneous drainage and antibiotics. despite this, some patients still prefer surgical intervention for various reasons. currently, there is a lack of studies on the outcomes of patients with acute complicated appendicitis who opt for surgery over conservative treatment, highlighting the need for further research. in practical terms, the benefits and risks of all treatment options should be thoroughly presented and discussed. recommendations for surgery versus a conservative treatment-first approach should be based on individual clinical and radiographic findings, as well as patient treatment expectations and preferences. this study aim to investigate the clinical significance of peri-appendiceal abscess or phlegmon in the surgical management of acute complicated appendicitis.

Eligibility criteria:
inclusion criteria: * patients who were aged ≥18 years, patients who were clinically diagnosed with acute appendicitis, patients who had a peri-appendiceal abscess or phlegmon on ct scan, patients who opted to undergo immediate emergency surgery as their primary choice, patients who refused conservative treatment first (antibiotic therapy and ultrasound/ct-guided drainage). exclusion criteria: * patients younger than 18 years, patients have a history of prior malignancies, patients with diffuse peritonitis, patients with incomplete clinical or pathological records.
post marketing surveillance to observe safety and efficacy of benefix in patients with hemophilia b

Conditions: Hemophilia B

Summary: to provide safety and effectiveness information of benefix during the post-marketing period as required by korea fda regulations, to identify any potential drug related treatment factors in korean population including: 1) unknown adverse reactions, especially serious adverse reactions; 2) changes in the incidences of adverse reactions under the routine drug uses. 3) factors that may affect the safety of the drug 4) factors that may affect the effectiveness of the drug

the patients who meet the inclusion criteria will be enrolled consecutively.

Eligibility criteria:
inclusion criteria: * patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement). * pediatric and adult patients who have been treated with original or reformulated benefix for hemophilia b (congenital factor ix deficiency or christmas disease) from first approved date by kfda, or who are planned to be newly prescribed benefix (for example, patients switching from pdfix to benefix). exclusion criteria: * patients with a known history of hypersensitivity to original or reformulated benefix or any component of the product. * patients with a known history of hypersensitivity to hamster protein. * patients participating in an interventional trial of any investigational drug or device.

Keywords: hemophilia b benefix safety efficacy
investigation of platelet function and aspirin resistance in chronic dialysis patient

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to determine whether aspirin resistance has impact on cardiovascular event in dialysis patient.

dialysis patient inevitably suffered from uremic bleeding although improvement of dialysis care in the past decades. physicians used to check bleeding time as a surrogate marker for uremic bleeding. however, bleeding time isn't accurate and as well known, is poorly correlated with clinical bleeding such as surgical bleeding. platelet function assay (pfa) is a newly developed method to measure platelet aggregation in vitro and is validated in many sorts of platelet disorders. recently, pfa was also used to evaluate aspirin responsiveness in patients who had taken aspirin. our study is aim to investigate uremic thrombocytopathy via pfa of dialysis patient in taiwan. furthermore, we will study aspirin resistance in dialysis patient.

Eligibility criteria:
inclusion criteria: * dialysis \>3 months * hb\>10 g/dl \& plt \> 10000 exclusion criteria: * using medication which interfere pfa except aspirin * terminal disease such as malignancy * active vasculitis

Keywords: aspirin resistance, platelet function assay, dialysis, end stage renal disease
renal denervation in patients with refractory hypertension

Conditions: Hypertension

Summary: the purpose of this study is to investigate the clinical utility of renal denervation for the treatment of refractory hypertension.


Eligibility criteria:
inclusion criteria: * systolic blood pressure of 160 mmhg or greater * on 3 or more antihypertensive medications * egfr \>= 45 ml/min exclusion criteria: * renal artery abnormalities * known secondary hypertension attributable to a cause other than sleep apnea * mi, angina, cva within 6 months * type 1 diabetes * others
the safety and effectiveness of fozivudine tidoxil in hiv-1 infected patients

Conditions: HIV Infections

Summary: to identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity. to identify the adverse event profile that defines the maximum tolerated dose. to characterize the single- and multiple-dose pharmacokinetics of fozivudine and its metabolites. to correlate the adverse event profile and antiviral activity of fozivudine with pharmacokinetic parameters.

in this double-blind, dose-escalating study, patients receive fozivudine tidoxil at one of 5 dosage levels for 4 weeks and are randomized with respect to once- or twice-daily administration (cohorts 2 vs. 3 and 4 vs. 5). within each cohort, 10 patients are randomized to the study drug and 2 to the placebo. at least 9 of the 12 patients enrolled in cohort 1 must complete the entire 4-week course before cohorts 2 and 3 are enrolled. at least 18 of these 24 patients must complete 2 weeks of the 4-week course before cohorts 4 and 5 are enrolled.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: primary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration. patients must have: * hiv-positive status. * one hiv rna count \> 10,000 copies/ml within 30 days prior to entry, with a second count at least 3-fold above or below the first value. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * active medical problems including chronic diarrhea and active opportunistic infections such as cryptococcosis, pneumocystis carinii, histoplasmosis, etc.. * malignancy for which systemic therapy or radiation therapy is expected to be required during the study. * any other disease or condition that would place a patient at undue risk or confound the results of the study. concurrent medication: excluded: systemic therapy for malignancy. prior medication: excluded: * zidovudine or any other nucleoside reverse transcriptase inhibitor. * immunomodulators within one month prior to study drug administration. * investigational drugs within 30 days prior to study drug administration. * systemic cytotoxic chemotherapy within 3 months prior to study drug administration. prior treatment: excluded: * extended-field radiation therapy within 3 months prior to study drug administration. * blood transfusion within 2 weeks prior to study drug administration.

Keywords: dose-response relationship, drug cohort studies anti-hiv agents
physical impairments in children with chronic renal failure

Conditions: Chronic Kidney Failure; Chronic Kidney Diseases

Summary: when the literature is examined, it is seen that the extent to which cough strength, grip strength, physical activity level and quality of life levels are affected in children with chronic kidney failure compared to healthy children is not sufficiently clarified. for this reason, this study aimed to reveal impairments in grip strength, cough strength, physical activity, sleep quality or quality of life in children with chronic renal failure compared to healthy children.

the aim of this study is to compare children and adolescents with chronic kidney disease with healthy children and adolescents in terms of grip strength, cough strength, physical activity, sleep quality and quality of life. participants will be evaluated for these parameters through clinical assessments, questionnaires and measurements. the aim of the study is to understand the health effects of chronic kidney disease and to provide the basis for improvements in the health management of these individuals.

Eligibility criteria:
inclusion criteria: for children and adolescents with chronic kidney failure * being between the ages of 8-18 * being clinically stable for at least the last 3 weeks * having the necessary cooperation for the measurements * being willing to participate in the study inclusion criteria for healthy children and adolescents: * being between the ages of 8-18, * having the necessary cooperation for the measurements, * being willing to participate in the research exclusion criteria: for children and adolescents with chronic kidney failure * having any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months * being a smoker or having quit * having had a kidney transplant. exclusion criteria for healthy children and adolescents: * having a history of any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months * having any chronic disease * being a smoker or having quit smoking

Keywords: chronic kidney failure muscle strength physical activity sleep quality quality of life
respiratory treatment of patients with moderate and severe traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: intracranial pressure (icp) in patients with traumatic brain injury (tbi) is influenced by several factors of which one is arterial co2 tension. patient with tbi are often sedated and mechanically ventilated in order to secure a stable paco2. this study compares two ventilation modus; pressure controlled ventilation (pc) and pressure regulated volume controlled ventilation (prvc) in order to observe which of the two ventilation strategies results in a more stable icp and arterial co2 pressure (paco2).


Eligibility criteria:
inclusion criteria: * informed consent obtained from the patients next-of-kin. * moderate or severe tbi according to head injury severity scale (glasgow coma scale (gcs) score 3-13). * treated at the neurosurgical icu or the main icu at st olav university hospital. * intubated and receiving controlled mechanical ventilation. * continuous measurement of icp with either an intraventricular or an intraparenchymal pressure monitor device. * sedation to a level of sedation corresponding to maas (motor activity assessment score) 0 or 1 with continuous intravenous infusions of midazolam/propofol and morphine/fentanyl/remifentanil14. exclusion criteria: * pregnancy * icp above 25 mmhg * ongoing cerebral anti edema therapy corresponding to step iii at st olav university hospital therapy guideline * continuous external drainage of cerebrospinal fluid (csf) * clinical pulmonary condition prohibiting changes in respiratory therapy

Keywords: traumatic brain injury intracranial pressure ventilation respiratory therapy
the effect of action control based intervention on adherence after cardiac rehabilitaiton

Conditions: Heart Failure

Summary: this will be a pilot study of the effect of an action control-based intervention (acbi) on adherence to prescribed diet and exercise programs after cardaic rehabilitation. the purposes of this study are to: 1. determine if an acbi has an effect on adherence to prescribed home exercise and diet regimens for individuals 6 weeks after participating in a cardiac rehabilitation program 2. examine whether there is a difference in response to the acbi between state-oriented individuals and action-oriented individuals. 3. test the interaction effect between action-orientation disposition and the intervention.

patients with cardiac problems are burdened with complex lifestyle changes involving medication, diet and exercise. non-adherence to prescribed treatment protocols is a major contributor to morbidity and mortality for these indiviudals. rehabbilitation programs provide the necessary education and supervision needed to promote health, however, non-adherence occurs even for those indiviudals with appropriate resources and motivation. most of the research up to this point deals with preparing indiviudals to be adherent. action control theory is focused on the mental processes that occur between the time an individual makes a decision to adhere and the moment when the appropriate activty either occurs or does not occur. this interventions tudy will compare rates of adherece between indivudals who receive an action control based educational intervention and those who do not.

Eligibility criteria:
inclusion criteria: * participants will be a convenience sample of english literate men and women over the age of 21 enrolled in a cardiac rehabilitation program and accessible by phone for follow-up. all participants are referred to rehabilitation by their physician. being enrolled in the program indicates the participants have experienced a serious cardiac event, either myocardial infarction and/or coronary surgery exclusion criteria: * non-english literate, uner teh age of 21

Keywords: adherence, cardiac rehabilitation
microparticles in pediatric inflammatory disease

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: the purpose of this study is to provide data correlating levels of microparticles that circulate in the blood and disease activity in children with inflammatory bowel disease (ibd). the hypothesis is that circulating microparticles will be higher in children with active ibd, show inflammatory activity, and will be low in patients in remission as well as in healthy controls.

once the response of microparticles to inflammation is defined in this patient population, the microparticles can be used as biomarkers of disease activity and could potentially use microparticles as targets of therapeutic agents. this cross sectional study will enroll 15 crohn's patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric crohn's disease activity index), 15 ulcerative colitis patients (5 inactive, 5 mild, 5 moderate-severe disease based on the pediatric ulcerative colitis activity index), and 10 healthy controls.

Eligibility criteria:
inclusion criteria: * children with ibd based on endoscopic, histologic, radiologic, or laboratory data * ages between 8 and 17 years old exclusion criteria: * anyone with a concurrent illness since infection can affect microparticle levels

Keywords: pediatric ibd microparticles