Kornimate/medical-research-clean huggingface dataset:
prevalence of post-thrombotic syndrome in deep-vein thrombosis (dvt) patients treated with dabigatran

Conditions: Postthrombotic Syndrome

Summary: the primary objective in this cross-sectional study is to assess the prevalence of post-thrombotic syndrome (pts) in the two treatment arms of the re-cover studies (warfarin versus dabigatran). pts will be assessed by the recently developed patient reported villalta (prv) score. secondary objectives: to assess in both treatment arms the 1. prevalence of recurrent venous thromboembolism (vte) after the discontinuation of study treatment. 2. prevalence of pts determined by the standard villalta score. 3. health related quality of life (hrqol).

in the re-cover- and re-cover ii studies, 5109 patients with deep-vein thrombosis (dvt) and/or pulmonary embolism (pe) were randomized to receive 6 months of treatment with either dabigatran (150 mg twice daily) or warfarin (once daily to maintain international normalized ratio (inr) 2.0-3.0). all patients received an initial 5-7 day phase of parenteral anticoagulant treatment. the studies were designed as double blind, double dummy trials. re-cover was conducted between april 2006 to november 2008 and re-cover ii between june 2008 and october 2010; they were completed in 2009 and 2011, respectively. a substantial number of patients are expected to have developed post-thrombotic syndrome (pts). however, since dabigatran provides a stable level of anticoagulation throughout the treatment period and knowing that the quality of anticoagulation is an important factor in the development of pts, we anticipate that a lower rate of pts will be seen in the dabigatran treated patients compared to warfarin. patients will be interviewed and examined by the investigator if they accept to attend a clinic visit. otherwise, a telephone interview will be performed if the patient refuses to meet up. pts will be determined using patient reported villalta (prv) score form. however, those who will meet for consultation will in addition be assessed for pts by the standard villalta score. the primary endpoint will be the prevalence of pts determined by patient reported villalta (prv) score. the secondary endpoints are 1- objectively verified dvt or pe after the discontinuation of treatment, 2- prevalence of pts determined by the standard villalta score, 3- health related quality of life (hrqol) determined by eq-5d (www.euroqol.org) and venous insufficiency epidemiological and economic study quality of life and symptom (veines-qol/sym) questionnaires. the investigators will recruit the subpopulation of patients who were included into the re-cover studies in the norway, sweden and canada.

Eligibility criteria:
inclusion criteria: 1. patients with dvt (±pe) treated in the re-cover studies. 2. signed written informed consent. exclusion criteria: 1. patients who refuse to participate 2. deceased patients

Keywords: postthrombotic syndrome venous thrombosis quality of life hemorrhage recurrence
candesartan cilexetil special drug use surveillance 「challenge - quality control」

Conditions: Hypertension

Summary: the purpose of this study is to gain an understanding of the actual use of candesartan cilexetil (blopress) in patients with hypertension, and to examine the changes in parameters such as blood pressure.

this special drug use surveillance was planned to gain an understanding of the actual use of candesartan cilexetil in the new anti-hypertensive treatment environment where angiotensin receptor blocker (arb) combination drugs have become commercially available. the surveillance also investigated the background factors of patients continuing treatment with candesartan cilexetil and patients who switched from candesartan cilexetil to arb combination drugs, as well as changes in parameters such as blood pressure. the usual adult dosage of candesartan cilexetil is 4 to 8 mg, administered orally, once daily. meanwhile, treatment was to be started at 2 mg once daily in patients with renal impairment and the dose could be increased up to 8 mg as necessary.

Eligibility criteria:
inclusion criteria: * hypertensive patients exclusion criteria: 1. inpatients 2. patients under dialysis (planned) 3. patients with a history of coronary artery disease/cerebrovascular disorder within 6 months 4. patients with ≥ class iii of the new york heart association (nyha) classification functional classification of heart failure 5. patients that have been prescribed with candesartan (this drug/ecard/unisia) in the past 6. patients who are pregnant or may possibly become pregnant

Keywords: drug therapy
target-controlled infusion anesthesia and post-induction hypotension

Conditions: General Anesthesia; Hemodynamic Instability

Summary: hemodynamic changes during induction of anesthesia may have adverse outcomes and should therefore be avoided. the decrease in blood pressure during induction of anesthesia with propofol is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil. target controlled infusion (tci) system aims to reach the theoretically targeted blood or brain concentration of anesthetic agents based on the patient's age, weight, and height, with computer-assisted algorithms. in manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight, which may cause hypotension in patients with low cardiovascular performance. as target-controlled infusion (tci) obviates the need to calculate the infusion rate manually, the use of tci may provide a better hemodynamic profile during anesthesia induction this study was designed to test the hypothesis that propofol by tci anesthesia induction is associated with a lower hypotension rate when compared with manual anesthesia induction

maintaining normotension is one of the top priorities for anesthesiologists due to its negative effects. although there are a lot of studies and knowledge on the topic approximately 20-30% of patients develop post-induction hypotension. mostly it occurs due to the adverse effects of anesthetics such as a decrease in systemic vascular resistance or cardiac output and the interplay between them. the risk can be minimized in two steps: first by identifying high-risk patients, and second with tight control of hemodynamic parameters. as a second step, tight hemodynamic control during induction may be done using target-controlled infusion (tci) systems, which systems help to adjust the dosage to the needs of each patient by measuring hypnotic effects through the bispectral index (bis). tci models for propofol have been previously compared with manual infusions, however, it is not clear whether it still contributes to or triggers hemodynamic deterioration. therefore in this study, the investigators' aim is to determine the effect of two different anesthesia techniques on the development of postinduction hypotension through hemodynamic parameters monitored by the pressure recording analytical method (pram). the secondary aim is to identify risk factors that can predict postinduction hypotension

Eligibility criteria:
inclusion criteria: * patients with the american society of anesthesiology physical status 1-3 * underwent major elective surgery * required intra-arterial blood pressure monitoring before induction. exclusion criteria: * under 18 years of age * arrhythmia (atrial fibrillation, frequent premature beat) * severe valvular heart disease * morbid obesity * intubation difficulty * drug addiction * treatment with opiates * pregnancy * emergency surgery

Keywords: general anesthesia target controlled infusion post-induction hypotension monitoring
phenotypic and genotypic characterisation of a large, multicentre italian cohort of 46, xy dsd patients

Conditions: 46, XY DSD

Summary: observational exploratory study of a cohort of pediatric and adolescent patients diagnosed with dsd karyotype 46,xy, a rare congenital clinical condition characterized by a disharmonic development between chromosomal sex, gonadal sex and/or phenotypic sex.

observational, retro-prospective, exploratory, multicentre study coordinate by the irccs azienda ospedaliero-universitaria of bologna, italy. the study consists of the collection and analysis of clinical, biochemical, instrumental and genetic data on pediatric and adolescent patients referred to partecipating centres in a given period with a diagnosis of 46,xy disorders of sex development (dsd). the primary aim of the study is to assess the number of 46,xy dsd patients referred to partecipating centres, describing the phenotypic, hormonal and genetic characterisation. the secondary aims are to assess the correlation between molecular diagnosis and ems/egs score (external masculinization score ed externalgenital score) and to evaluate the diagnostic rate over the reporting period.

Eligibility criteria:
inclusion criteria: * karyotype 46,xy dsd; * genital ambiguity signs assessed on the basis of clinical phenotype and ems/egs for karyotype 46,xy dsd; * age \< 18 years at diagnosis of 46,xy dsd; * patients referred to the irccs azienda ospedaliero-universitaria di bologna since 01/01/1991 or to other participating centres since 01/01/2000; * obtaining informed consent from patients or from parents/legal guardian of pediatric patients. exclusion criteria: • none.

Keywords: 46 xy dsd
sodium selenite as a cytotoxic agent in advanced carcinoma

Conditions: Malignant Tumor; Treatment Resistant Disorders; Tumor Progression

Summary: in vitro studies have demonstrated that sodium selenite in sufficient concentration and during sufficient time have a high tumoricidal capacity. this is found in many human cell types as leukemia cells, mesothelioma and non-small cell lung cancer cells. a minority of cell lines seem to be resistant. the question from a clinical point of view is: is it possible with respect to toxicity to administer sodium selenite to patients in sufficient dose and during sufficient time to get responses in patients with cancer? we have performed first part of phase-1 study and found mtd of 10.2 mg/m2 if given as 10 daily infusions during 12 days. we have recorded limited anti-tumor effect in this treatment regimen. however, in vitro data suggest that low concentration of continuous exposure for 51 h is much more effective. now we are planning to continue the phase-i trial with modified protocol. more specific: 1. phase i: find maximal tolerable dose with continuous infusion 2. phase ii: use mtd and study responses, if any

* patients: with advanced malignant disease, any kind, in which all standard treatment has been tried, but still progression. in sufficient good performance status (ps 0-2)to get more treatment: first selenite and immediately afterwards chemotherapy (since an additive or synergistic effect from selenite and chemotherapy has been found). * treatment: we have performed the initial study with sodium selenite i.v. daily, 10 treatments during 2 weeks. the week after that response evaluation and then chemotherapy. in each patient, his or her first line chemotherapy treatment is given, since in vitro studies indicate that selenite might reverse resistance. in the modified protocol, a 2 days continuous infusion will be performed. * toxicity evaluation (main criteria in phase i): meeting a doctor once a week during selenite treatment and before each chemotherapy treatment and at end of treatment. meeting a nurse each treatment day during selenite treatment. blood samples for liver, kidney, blood and thyroid values. plasma samples for selenite concentration during treatment. * response evaluation (to be: main criteria in phase ii and studied also in phase i): ct scan just before and after selenite treatment and after chemotherapy. from may 2011 fdg-pet-ct-scan just before and after selenite treatment. cytokeratin and cytokeratin fragments evaluation.

Eligibility criteria:
inclusion criteria: * advanced malignant tumor disease * all standard treatments should have been tested, but the disease still progressing. * in sufficient good performance status to get more treatment * informed consent exclusion criteria: * more than 1 active tumour disease * impaired capacity to cooperate * serious other disease such as heart or kidney disease that might give extra risk for complications and difficulties to interpret effect of the selenite treatment * the tumour not possible to evaluate

Keywords: phase i study for safety later phase ii study for responses
lens wearing experience and biocompatibility of a marketed multi-purpose disinfecting solution in silicone hydrogel and soft contact lens wearers

Conditions: Refractive Error

Summary: the purpose of this study was to describe mean differences in corneal staining (type and area) for opti-free puremoist multi-purpose disinfecting solution (mpds) at day 30 compared to baseline (day 0).


Eligibility criteria:
inclusion criteria: * 18 years or older * soft contact lens wear on a daily wear basis * able to wear contact lenses for at least 8 hours * generally healthy and have normal ocular health * other protocol-defined inclusion criteria may apply exclusion criteria: * no use of additional lens cleaners * no known sensitivities to any ingredient in the test article * no history of ocular surgery/trauma within the last six months * other protocol-defined exclusion criteria may apply

Keywords: soft contact lenses multi-purpose solution corneal staining
guidance of ultrasound in intensive care to direct euvolemia

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to assess the effectiveness of routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (gdt)-based fluid resuscitation in reducing acute kidney injury (aki) incidence and duration in trauma patients in a teaching institution.


Eligibility criteria:
inclusion criteria: * injured patients that are admitted to the trauma icu exclusion criteria: * incarceration * pregnancy
nutriomics and artificial intelligence nutrition obesity cohort

Conditions: Obesity

Summary: the purpose of this study is to establish a prospective cohort. from registration to the 5th year, basic investigation, specific examinations for cardiovascular and metabolic disease, basic blood tests, collection of human material samples, and clinical event follow-up are conducted yearly. the obese group will be examined yearly, and telephone follow-up will be conducted if necessary. the control group will participate in the baseline survey once enrollment and clinical event follow-up by phone will be conducted annually thereafter. from the 6th year, only clinical event follow-up will be conducted.

the obese group will enroll 500 people within 1 year of study initiation and follow-up annually. the control group will enroll 30 patients a year for 5 years.

Eligibility criteria:
inclusion criteria for the obese group 1. adults 19 years of age or older 2. obese patients with chronic diseases such as cardiovascular disease, hypertension, diabetes, and metabolic syndrome (bmi ≥ 25 kg/m2, \[bmi ≥ 30 kg/m2, including 10% or more\]) inclusion criteria for the control group 1. adults 19 years of age or older 2. those with bmi 18.5\~24.9 kg/m2 exclusion criteria for the obese group 1. serious non-cardiovascular disease with life expectancy less than 6 months 2. pregnant or suspected of being pregnant or are lactating 3. patients within 3 months of organ transplantation 4. patients currently being treated for acute transplant rejection 5. patients treated for acute coronary syndrome (myocardial infarction, unstable angina) and discharged within 6 months 6. patients with acute cerebral infarction within 6 months of being hospitalized and discharged 7. type 1 diabetes 8. patients taking steroids, female hormones 9. those who have difficulty using smartphones exclusion criteria for the control group 1. serious non-cardiovascular disease with life expectancy less than 6 months 2. pregnant or suspected of being pregnant or are lactating 3. persons who are continuously taking medications prescribed by a doctor due to chronic diseases excluding hypertension and dyslipidemia 4. within 5 years of diagnosis of malignant tumor 5. those who have difficulty using smartphones
self-reported and experimental pain in patients undergoing orthodontic treatment

Conditions: Pain

Summary: pressure pain threshold (ppt) is defined as the minimum force applied to an area that is perceived as pain. ppt is considered an objective measurement tool to assess pain levels. studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. no study has utilized ppt to evaluate the difference in pain between aligners and fixed braces at different time points. this study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance.


Eligibility criteria:
inclusion criteria: * consecutive consented patients (\> 14 years old) beginning an orthodontic treatment on both arches, either with aligners or fixed appliance at the midwestern university, multidisciplinary clinic; * patients in possession of an email address and internet connection. exclusion criteria: * patients with generalized systemic conditions known to affect the overall body pain and pressure pain threshold assessment (e.g., fibromyalgia, autoimmune conditions such as multiple sclerosis, rheumatoid arthritis), * untreated dental caries.

Keywords: pressure pain threshold clear aligners orthodontic appliance adolescents self-reported pain
surgical resection and intraoperative cesium-131 brachytherapy for head and neck cancer

Conditions: Recurrent Head and Neck Carcinoma

Summary: this pilot clinical trial studies cesium cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. radioactive drugs, such as cesium cs 131, may carry radiation directly to tumor cells and not harm normal cells. permanently implanting cesium cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be in the tissue after surgical removal of the tumor.

primary objectives: i. assess the impact of cesium 131 (cesium cs 131) on recurrence rate, disease free survival and over all survival. secondary objectives: i. assess complications associated with cesium 131 treatment in subjects with head and neck cancer. outline: patients undergo brachytherapy using cesium cs 131 during surgical resection. after completion of study treatment, patients are followed up at 30 days and then every 3 months for 24 months.

Eligibility criteria:
inclusion criteria: 1. diagnosis: subjects with a diagnosis of recurrent head and neck cancer 2. based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively 3. age: subjects must be ≥ 18 years of age and ≤ 90 years old 4. informed consent: all subjects must be able to comprehend and sign a written informed consent document exclusion criteria: 1. subjects who are pregnant or may become pregnant 2. unresectable tumor 3. other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study
immune response to influenza vaccine in adults with b-cell malignancies treated with idelalisib

Conditions: B-cell Malignancies

Summary: the primary objective of this study is to assess the immune response to an influenza vaccine in adults with b-cell malignancies who are currently receiving treatment with idelalisib in a gilead-sponsored study (parent study).


Eligibility criteria:
key inclusion criteria: * currently enrolled in a gilead-sponsored study, receiving or scheduled to initiate treatment with idelalisib for at least 7 consecutive days prior to receiving an influenza vaccine * will be receiving an influenza vaccine per standard of care * willing to comply with scheduled visits, laboratory tests, other study procedures, and study restrictions * signed informed consent form, indicating that the subject has been informed of the procedures to be followed, potential risks and discomforts, and other pertinent aspects of study participation key exclusion criteria: * administration of systemic steroids for more than 2 consecutive weeks within the past 3 months (i.e., 12 weeks) prior to receiving an influenza vaccination. up to 3 single doses of systemic corticosteroids (e.g., given as a premedication) are permitted within 30 days prior to receiving an influenza vaccine, however none of these doses may be administered within 7 days prior to influenza vaccination. topical and inhaled steroids are permitted * intravenous immunoglobulin (ivig) therapy within the past 3 months (i.e., 12 weeks) prior to receiving an influenza vaccination, and/or planned administration during the study period * cytotoxic chemotherapy and chronic administration (more than 14 days) of immunosuppressants within 30 days of vaccination * vaccination against influenza within the last 24 weeks prior to vaccination in this study, and/or planned administration of a second dose of influenza vaccine during the study period. * receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination * history of severe allergic or hypersensitivity reaction that is likely to be exacerbated by any component of an influenza vaccine including egg and chicken protein, or history of hypersensitivity to a previous dose of an influenza vaccine * acute disease and/or fever at the time of baseline blood draw (fever is defined as temperature ≥ 38°c in an oral setting) * presence of any condition that could, in the opinion of the investigator, compromise the subject's ability to participate in the study, such as history of substance abuse or psychiatric condition * females who are pregnant or lactating (refer to the gilead-sponsored parent study's definition of 'child-bearing potential' to determine if pregnancy testing is required. if a pregnancy test has been performed in the gilead-sponsored parent study ≤ 6 weeks prior to the baseline blood draw, it may be used for eligibility purposes. note: note: other protocol defined inclusion/exclusion criteria may apply.