Kornimate/medical-research-clean huggingface dataset:
long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in north america. the aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in canadian subjects with type 2 diabetes who had participated in the biasp-1237 trial.


Eligibility criteria:
inclusion criteria: * completed the biasp-1237 trial
a phase 1, single- and multi-dose, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered aln-ttrsc (revusiran) in healthy volunteers

Conditions: TTR-mediated Amyloidosis

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of aln-ttrsc (revusiran) in healthy volunteer subjects.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) must be ≥ 16.5 kg/m2 and ≤ 35.0 kg/m2; * female subjects must be of non-childbearing potential; e.g., postmenopausal or pre-menopausal with surgical sterilization; * male subjects agree to use appropriate contraception; * adequate blood counts, liver and renal function; * non-smokers for at least 3 months; * willing to give written informed consent and are willing to comply with the study requirements; * subject was born in japan and has lived outside of japan for \<10 years, and subject's biological parents and grandparents are fully japanese and were born in japan (cohorts 19 and 20). exclusion criteria: * known human immunodeficiency virus (hiv) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection; * subjects with a history of multiple drug allergies or intolerance to sc injection; * history of drug abuse and/or alcohol abuse; * receiving an investigational agent within 3 months prior to study drug administration; * considered unfit for the study by the principal investigator.

Keywords: rnai therapeutic
study of licarbazepine in the treatment of manic episodes of bipolar disorder

Conditions: Bipolar Disorder

Summary: the purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. the investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. these medications are already fda (food and drug administration)-approved treatments for mania.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder (type i) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling) * in need of psychiatric treatment * cooperation and willingness to complete all aspects of the study exclusion criteria: * current diagnosis other than bipolar i disorder * history of schizophrenia or schizoaffective disorder * drug dependence within 1 month prior to study start or testing positive in a urine drug test * suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others * any form of psychotherapy within 1 month prior to study start

Keywords: bipolar disorder manic episode treatment licarbazepine
tvt-secur as an office-based procedure

Conditions: Urinary Incontinence; Stress Urinary Incontinence

Summary: this is a pilot study to assess the feasibility and success of performing the tvt-secur in the office setting. endpoints would be success, complications, and patient and physician acceptance of the procedure. success would be assessed by validated questionnaires. this is a prospective single arm study of 50 patients who will have the tvt-secur procedure done in the office under local anesthesia. they will be followed for a period of 3 years.

the study will include 50 patients who would meet the inclusion/exclusion criteria and who sign the informed consent. subjects are diagnosed with stress urinary incontinence resulting from urethral hypermobility with no prior urinary incontinence surgery. subjects are women who no longer intend to bear children and who do not require any other concomitant surgery.

Eligibility criteria:
inclusion criteria: * stress urinary incontinence with hypermobility of the uv junction * asa i or ii * age 21-89 exclusion criteria: * prior anti-incontinence surgery * not completed childbearing * asa iii or higher * need concomitant surgery * poor compliance for office based approach

Keywords: urinary incontinence stress urinary incontinence mid-urethral slings tension-free vaginal taping tvt
dect in imaging patients with solid organ cancer with intracranial metastasis

Conditions: Malignant Neoplasm; Metastatic Malignant Neoplasm in the Brain

Summary: this trial studies how well dual energy computed tomography (dect) works in imaging patients with solid organ cancer that has spread to the brain. imaging techniques, such as dect, may help find and diagnose tumor cells and find out how far the tumor cells have spread in the brain.

primary objectives: i. to optimize two major parameters of computed tomography (ct) imaging for optimal detection of intracranial metastatic lesions. ia. virtual monochromatic image reconstruction. ib. contrast bolus timing. ii. to measure the detection accuracy of ct compared to the diagnostic standard of care gadolinium-based "gamma knife (gk)" protocol magnetic resonance imaging (mri). outline: within 7 days before the standard gamma knife mri, patients undergo dect scan over 6 seconds at 1.5, 5, 10, and 20 minutes after receiving the contrast agent.

Eligibility criteria:
inclusion criteria: * adult patient with pathology-proven solid organ cancer * mri of the brain with contrast, positive for two or more metastatic lesions * one lesion with a single greatest diameter on contrast-enhanced mri of 1 cm or greater * planned treatment with stereotactic radiosurgery exclusion criteria: * known allergy to iodine-based contrast agents * patients with glomerular filtration rate (gfr) less than 30 or use of hemodialysis * if prior nephrectomy, gfr less than 60 * prior central nervous system malignancy * prior brain radiation * pregnant women are excluded
distress associated with coronavirus disease 2019 and telehealth on supportive care patients with advanced cancer

Conditions: Advanced Malignant Solid Neoplasm; COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Hematologic Malignancy; Recurrent Malignant Solid Neoplasm

Summary: this study assesses the level of distress felt by cancer patients due to the coronavirus disease 2019 (covid-19) pandemic. researchers also want to learn if patients prefer to receive supportive care (palliative care) in person or through telemedicine (visits by phone or video call, such as zoom). information from this study may help doctors better understand how covid-19 has affected patients with advanced cancer, patients' perceptions of telehealth, and may help clinicians tailor care to patients' needs during the pandemic.

primary objectives: i. assess advanced cancer patients' level of distress due to the covid-19 pandemic. ii. assess patients' overall preference towards palliative telemedicine vs in person visits during the covid-19 pandemic. secondary objectives: i. assess associations between patient characteristics and perceptions of overall distress due to the covid-19 pandemic. ii. assess associations between patient characteristics and their attitudes and beliefs towards palliative telemedicine during the covid-19 pandemic. iii. compare the attitudes and beliefs towards palliative telemedicine between patients who completed visits via video vs telephone. outline: patients complete survey over 20 minutes.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease * age 18 or greater * patient presenting for at least two follow-up visits with supportive care visit since the covid19 pandemic (after march 23, 2020), consisting of either in-person, or virtual * for patients who have had two consecutive video visits, or consecutive telephone visits with supportive care, they will be asked to complete additional questions regarding telehealth visits exclusion criteria: * memorial delirium assessment scale (mdas) of 7 or more or if determined to be of impaired cognition by the clinician at the time of clinic visit as documented in the visit either by history or exam. providers routinely note screening for mental status with routine administration of the mdas or history of altered cognition or noted on exam * non-english-speaking participants * unwilling or unable to provide informed consent
videoendoscopic radical inguinal lymphadenectomy for penile cancer

Conditions: Penile Cancer; Inguinal Lymphadenopathy; Melanoma

Summary: assess the feasibility of performing a rct comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an rct.

there is increasing interest in using videoendoscopic inguinal lymph node dissection (ilnd) as an alternative to open ilnd. videoendoscopic inguinal lymphadenectomy (veil) may decrease complications compared to open ilnd and provide equivalent short-term oncological outcomes. as yet, there have been no randomised-controlled trials (rcts) comparing these procedures. velrad aims to assess the feasibility of performing a rct comparing veil and open ilnd. this will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. investigators will also collect qualitative data on why patients did or did not agree to be randomised

Eligibility criteria:
inclusion criteria: 1. people requiring inguinal lymphadenectomy i.e. 1. patients with squamous cell carcinoma or mucosal melanoma of the penis \> t1bg2 or patients with male genital cancer requiring inguinal lymphadenectomy 2. patients unsuitable for dynamic sentinel node biopsy (dsnb) with impalpable nodes: previous penectomy or non-visualisation at previous dsnb 3. previous dsnb with metastatic inguinal nodes on histology or fna positive nodes on cytology who require a completion radical inguinal lymphadenectomy 4. small volume palpable inguinal lymph nodes (\< 2 cm on ct) not fixed to skin 2. age \> 18 years exclusion criteria: 1. unfit for surgery 2. people unlikely to benefit from lymphadenectomy because of advanced cancer 3. those with palpable inguinal lymph nodes fixed to skin or adjacent structures 4. does not want to participate in the trial or unable to provide informed consent
viability and cardiac resynchronization therapy

Conditions: Heart Failure; Ischemic Cardiomyopathy

Summary: 30% of heart failure patients that receive a device for cardiac resynchronization therapy fail to show clinical improvement. the reason for lack of response is still unclear but factors such as scar tissue in the heart musculature, inadequate lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. in this study, these factors are further investigated.

cardiac resynchronization therapy (crt) is an established therapy for patients with severe heart failure, depressed left ventricular function and a wide qrs-complex. large clinical trials have demonstrated unequivocal improvements in functional status, morbidity and mortality. however, 30 % of heart failure patients treated with a crt-device do not benefit clinically. several factors have been suggested to be important for the response to crt such as mechanical dyssynchrony, presence of scar tissue in the myocardium, and device-optimization (among others). it is the purpose of this study to investigate the importance of these factors. 100 patients with ischemic cardiomyopathy, eligible to crt according to current guidelines, will be included. patients are randomised to two arms. one group will have atrioventricular (av)-optimization after implantation, the other av -and interventricular (vv)-optimization. after 4 months patients are crossed-over to the other arm. preimplantation patients are mr-scanned and low-dose dobutamine stress-echocardiography is performed. furthermore patients will be examined by echocardiography and evaluation of clinical status 1. mechanical dyssynchrony can predict response to crt. b. measures of mechanical dyssynchrony is related to myocardial viability and conduction. 2. individual optimization based on conduction times will increase benefit to crt. b. the effect of adding vv-optimization is related to myocardial viability. 3. \> 30 % of non-viable tissue globally in the myocardium is predictive of lack of crt- response. b. non-viable tissue located in the area of the left ventricular lead is predictive of non-response.

Eligibility criteria:
inclusion criteria: * lvef\ /= 120 ms, nyha-class ii- iv. * ischemic heart disease (\> 50% stenosis in 1 or more major epicardial coronary artery or prior pci or cabg.) * optimal treatment ( beta-blocker, ace-1 or arb and spironolactone) exclusion criteria: * pregnancy * unstable angina pectoris * chronical atrial fibrillation * severe valvular disease * dementia or mental retardation * severe claustrophobia * acute myocardial infarction \< 3 months * severe health condition threatening short-term survival * severe kidney insufficiency, gfr \< 35 ml/min/1.73 m2 * metal implants contraindicative of magnetic resonance scan

Keywords: heart failure cardiac resynchronization therapy optimization viability mechanical dyssynchrony
azd8683 multiple dose study in healthy volunteers and chronic obstructive pulmonary disease (copd) patients

Conditions: COPD

Summary: this study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of azd8683 in healthy volunteers and repeated inhalation of one dose level of azd8683 in patients with chronic obstructive pulmonary disease given once daily.

a phase i, single centre, double-blind, randomised, placebo- controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of azd8683 in healthy volunteers and copd patients

Eligibility criteria:
inclusion criteria: * healthy male volunteers and healthy female volunteers of non-child bearing potential, aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture - healthy volunteers * have a body mass index (bmi) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive - healthy volunteers and copd patients * be able to inhale from the turbuhaler® inhaler according to given instructions as well as be able to perform spirometry -healthy volunteers and copd patients. * male copd patients or female copd patients of non-childbearing potential (post menopausal or surgically sterilised) aged ≥40 years at visit 1 - copd patients * female healthy volunteers and female patients ≤60 years must have a negative pregnancy test at screening and on admission to the unit - healthy volunteers and copd patients exclusion criteria: * prolonged qtcf \>450 ms or shortened qtcf \<340 ms or family history of long qt syndrome - healthy volunteers and copd patients * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to azd8683 or excipients:healthy volunteers and copd patients * history or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - healthy volunteers and copd patients * any clinically significant illness (other than copd), medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - copd patients * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - healthy volunteers

Keywords: safety tolerability healthy copd (chronic obstructive pulmonary disease) pharmacokinetic pharmacodynamic inhaled
real-world effectiveness of regorafenib in the treatment of patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: real-world effectiveness of regorafenib in the treatment of patients with hepatocellular carcinoma

to analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with hepatocellular carcinoma. this retrospective, observational study included clinicopathological and follow-up data of patients with hepatocellular carcinoma who were treated with regorafenib from june 2017 to september 2020. patients with incomplete data were excluded. overall survival (os) stratified by combination therapy with programmed cell death ligand-1 (pd-l1) inhibitors, chemotherapy and regorafenib dose was calculated by kaplan meier method and log rank test. r software version 4.0 was used for the analysis.

Eligibility criteria:
1. inclusion criteria: 1. must be a pathologically proven hepatocellular carcinoma 2. must have been treated with regorafenib 3. regorafenib must be used after two lines of standard antitumor therapy 2. exclusion criteria: 1. application is less than one course of treatment with regorafenib 2. first - or second-line treatment with regorafenib 3. patients with multiple primary cancers

Keywords: hepatocellular carcinoma regorafenib
epipage2 cohort study follow up at five and a half years

Conditions: Very Preterm Birth

Summary: epipage 2 (epidemiologic study on small-for-gestational-age children) is a nationwide study implemented to improve our knowledge of the outcome of preterm children in france. this study was launched on march 28, 2011 and includes three groups of preterm children, all born before 35 weeks: extremely preterm infants (born between 22 and 26 completed weeks of gestation), very preterm children (born between 27 and 31 completed weeks) and moderately preterm children (born between 32 and 34 completed weeks). these children are being studied from their birth up to the age of 12 years. at birth, data on maternal and infants' characteristics were collected from medical records. at one and two years, questionnaires sent to families and to physicians (at two years only) allowed to collect data about the children's life and health. at five and a half years, medical and psychological assessments are specifically implemented for the study in order to evaluate motor and cognitive disorders in this population.


Eligibility criteria:
inclusion criteria: * initially included in epipage 2 cohort or complementary studies or elfe cohort study * family agreement to participate to cohort follow up * informed consent form signed by both parents * affiliated to social security system exclusion criteria: * parental refusal * not affiliated to any social security system

Keywords: very preterm birth developmental disorders health problems prospective population-based cohort
randomised controlled trial to investigate the effect of parental presence at intensive care unit to ward transfer bedside rounds on parental anxiety and children's safety

Conditions: Parental Anxiety; Children's Safety

Summary: the investigators shall conduct a randomized controlled trial to investigate the effect of parental presence at transfer rounds on parental anxiety and patient safety following transfer from the pediatric cardiac intensive care unit (pcicu) to the ward. the investigators plan to test the hypothesis that parental involvement in the child's transfer, with the option of peer support, will result in measurable reductions in medication errors, unplanned nutritional and feeding management, and parental anxiety after transfer as compared to the control group. the investigators goal is to improve continuity of care by implementing multidisciplinary transfer rounds at the child's bedside in which patients and family share in the control of the management plan when a cardiac child is discharged from pcicu to the ward.


Eligibility criteria:
inclusion criteria: * parents of cardiac children aged 1 day to 17 years admitted to pcicu * written informed consent and assent when appropriate * planned discharge from the pcicu to the ward. exclusion criteria: * parents with less than grade 6 reading skills as they will not be able to independently take the spielberger's state -trait anxiety inventory (stai). * parents who are not willing to be randomized to the control group in which they cannot be present for transfer rounds. * neonates being discharged from pcicu to nicu or neonates being discharged from nicu to wards.

Keywords: parental anxiety children's safety family centered care bedside transfer rounds pediatric cardiac intensive care
a study of gene polymorphisms and normal tissue radiation injury in patients treated for breast, prostate, brain, lung, and head and neck cancers

Conditions: Breast Cancer; Glioma; Prostate Cancer; Carcinoma, Squamous Cell; Carcinoma, Non-Small-Cell-Lung; Head and Neck Cancer

Summary: this study will examine, for the first time, the independent contribution of a patient's own genetic makeup to the development of post-radiation complications, permitting the future development of predictive tests to avoid radiation injury. to do this, the investigators will examine gene markers in a series of breast, prostate, brain and lung cancer survivors who have received conformal radiotherapy between 1996 and 2003 at the cross cancer institute and tom baker cancer centre.

major innovations in radiotherapy (rt) delivery (3d conformal rt, intensity modulated rt) now permit rt dose escalation to be tested as a means of improving disease control in many tumour sites. with delivery innovations, life-threatening toxicity occurs rarely, but significant clinical toxicity is common. in previous work the investigators have studied a cohort of 98 prostate patients who received dose-escalated 3d-crt and have obtained evidence of genetic and dosimetric factors underlying rectal/bladder toxicity. they posit that the late radiation toxicity disease state has significant genetic determinants in other malignancies. these determinants are neither understood nor accounted for in selection of treatment, and the investigators propose to study additional well-characterized cohorts, who are clinically well from a disease control perspective, given that comprehensive dosimetric and outcome information is available on all. for a thorough understanding of the molecular processes underlying tissue responses to radiation damage, the investigators propose a genomic analysis. their working hypothesis is that normal organ toxicity will be associated with patient genetics as measured by single nucleotide polymorphisms (snps) in a select group of genes. the criteria for selecting snps will be based on a candidate gene approach, choosing genes implicated or demonstrated in dna repair pathways and radiation-induced tissue damage/tissue homeostasis. analysis of these data will use both statistically based bioinformatics approaches.

Eligibility criteria:
inclusion criteria: * breast cancer * prostate cancer * squamous cell carcinoma (scc) of the head and neck * non-small-cell-lung carcinoma (nsclc) * glioma treated by radiotherapy exclusion criteria: * follow-up less than 18 months

Keywords: radiotherapy radiation toxicity single nucleotide polymorphism breast carcinoma prostate carcinoma squamous cell carcinoma of the head and neck lung carcinoma (non-small cell)