Kornimate/medical-research-clean huggingface dataset:
evaluation of a new generation of pet-ct omni

Conditions: Oncology

Summary: the overarching purpose of the study is to provide supporting evidence to the value proposition of omni, that offers global access to an affordable hybrid pet/ct system similar in performance to that of systems utilized by world-class academic centers. specifically, the study will collect a library of oncology 18fdg pet image data from the omni system and evaluate the images as compared to the standard of care pet/ct systems. this evaluation is being performed as a necessary part of product development in order to obtain user feedback on device performance, user preference, image quality (iq), workflow, and new device features. this study will also help to inform protocol development in reducing both scan time and radiologic tracer dose.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. a clinical indication for fluorodeoxyglucose (fdg or 18f-fdg) pet/ct examination according to current clinical practice standards; 3. have ≥ 1 who karnofsky index \< 70; 4. are able to maintain a supine position twice; 5. are affiliated with a social security scheme in france; and, 6. are able and willing to provide informed consent for participation in this study, per the ec approved policy. exclusion criteria: 1. have uncontrolled diabetes; 2. have a formal contraindication to certain imaging examinations (i.e., significant claustrophobia, or other contraindications as determined by the ordering physician.) 3. are known to be pregnant or breastfeeding (the investigational site will follow their standard practice of verifying for women of childbearing age; or, 4. are known to have any psychological, family, geographic, or sociological condition that does not allow compliance with the medical monitoring and/or the procedures provided for in the study protocol.
evidence based dissemination for mammography adherence in safety net communities

Conditions: Breast Cancer

Summary: breast cancer is the most common cancer and the second leading cause of cancer related death in american women. regular screening, early diagnosis, and timely treatment initiation have been shown to reduce breast cancer morbidity and mortality. however, disparities continue to exist across the breast cancer continuum for underserved women, particularly minority women. the reduction of disparities in breast cancer outcomes is a major goal of healthy people 2020 and the national cancer institute. however, the preventable burden of late stage breast cancer will continue until the investigators close the gap between what is known about prevention and what is implemented in the community. although many sources of information exist about theory and \[theory-\] and evidence-based interventions (ebis) to promote mammography screening, their adoption and use in the community has been limited and haphazard at best.

in order to effectively reach underserved women and reduce breast cancer disparities, d\&i efforts should target the healthcare delivery system where these women receive service - the so called "safety net". within the safety net, federally qualified health centers (fqhcs), provide comprehensive primary health care services for underserved communities regardless of ability to pay, including mammography screening. our team has successfully pilot tested a national cancer institute research tested intervention program (rtip) with underserved women and were able to reduce no-show rates from 44% to 19%. in order to accelerate the adoption and implementation of our ebi within the safety net, the investigators will use a two-step approach based on the consolidated framework for implementation research (cfir), and intervention mapping. the investigators will actively disseminate the ebi through a unique breast health collaborative with a wide membership of fqhcs, support implementation through training and evaluate the adoption, implementation, sustainment and effectiveness of the ebi. the investigators will use a clinic clustered stepped wedge design for implementation in fqhcs.

Eligibility criteria:
inclusion criteria: * underserved as defined by income \<=200% of the federal poverty level for a family of four * uninsured * in need of mammography screening; has received clinical breast exam and referral to screening * has upcoming screening appointment exclusion criteria: -

Keywords: evidence-based intervention mammography underserved population
study of zg006 in participants with neuroendocrine prostate cancer

Conditions: Neuroendocrine Prostate Cancer

Summary: this is a multicenter, open-label phase ii study, aimed at exploring the preliminary efficacy and safety of zg006 in patients with advanced metastatic nepc who have previously failed standard treatment.


Eligibility criteria:
inclusion criteria: * male participants aged 18 to 80 years (inclusive); * advanced metastatic neuroendocrine prostate cancer; * disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity; * measurable disease according to recist v1.1 criteria; * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * known positive test for human immunodeficiency virus (hiv) or hepatitis； * patients were deemed unsuitable for participating in the study by the investigator for any reason.
doxazosin and ramipril in hypertension

Conditions: Hypertension

Summary: randomized double-blind parallel group study in patients with mild-to-moderate hypertension to evaluate the effects beyond the blood pressure lowering effect of treatment for 12 weeks with ramipril or doxazosin on hemostatic mechanisms and on endothelial function.

this study aims to answer the following questions: 1) does antihypertensive therapy with doxazosin exhibit antithrombotic effects in patients with essential hypertension? 2) are the potential antithrombotic effects of doxazosin different to the effects of an ace inhibitor? 3) is there a relation between the antihypertensive effect and the antithrombotic effect of these antihypertensive agents? the co-primary outcomes are changes in endothelial function assessed by flow mediated vasodilatation, and in haemostatic function measured by the generation of thrombin-antithrombin complex.

Eligibility criteria:
inclusion criteria: * primary mild-to-moderate hypertension exclusion criteria: * pregnancy and lactation * recent (6 months) malignant disease or ongoing treatment for malignancy * no absolute indication or contraindication for any of the study drugs

Keywords: hypertension blood pressure hemostasis endothelial function
virtual reality trial using easevrx for chronic low back pain

Conditions: Chronic Lower Back Pain

Summary: randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a self-administered virtual reality program for the treatment of chronic lower back pain compared to a placebo vr program.

a randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a self-administered virtual reality (vr) program for the treatment of chronic lower back pain. the primary objective of this study is to assess the impact of skills-based vr on changes in patient-reported pain and pain interference over the course of an 8-week intervention as well as compared to a placebo vr condition. the secondary objective is to assess the impact of skill-based vr on changes in patient-reported satisfaction over the course of an 8-week intervention and compared to a placebo vr condition. a tertiary objective is to assess the impact of skills-based vr on changes in patient-reported opioid use, physical function, behavioral skills development, and health outcomes immediately following the intervention relative to a pre-intervention baseline and compared to a placebo vr condition. an exploratory objective is to assess the impact of skills-based vr on changes in patient-reported pain levels, opioid use, physical function, behavioral skills development, health outcomes, and satisfaction at the 24-week post-intervention time point and compared to a placebo vr condition.

Eligibility criteria:
inclusion criteria: * men and women 18-85 years old * diagnosis of low back pain without radicular symptoms * pain duration of at least 6 months * average pain intensity of at least 4 on the 0-10 dod/va pain scale for the past month at screening * english fluency * willing to comply with study procedures/restrictions exclusion criteria: * unable to understand the goals of the study due to cognitive difficulty * current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other neurological disease that may prevent the use of vr * medical condition predisposing to nausea or dizziness * hypersensitivity to flashing light or motion * no stereoscopic vision or severe hearing impairment * injury to eyes, face or neck that prevents comfortable use of vr * pain related to cancer * active suicidal ideation or severe depression * previous use of easevr for pain * current participation in any interventional research study or completed participation in past 2 months * currently pregnant or planning to become pregnant * does not have access to wifi during participation in study * currently works at or has an immediate family member who works for a digital health company or pharmaceutical company that provides treatments for acute or chronic pain

Keywords: virtual reality chronic lower back pain analgesia
phase ii study to investigate the benefits of an improved deferasirox formulation (film-coated tablet)

Conditions: Chronic Iron Overload Due to Transfusion-dependant Anemias

Summary: assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, gastrointestinal (gi) tolerability, palatability, satisfaction and compliance


Eligibility criteria:
key inclusion criteria: * male and female patients aged ≥ 10 years * patients with transfusion-dependent thalassemia and iron overload, requiring deferasirox dt at doses of ≥ 30 mg/kg/day as per the investigator's decision or patients with very low, low or intermediate (int) risk myelodysplastic syndrome (mds) and iron overload, requiring deferasirox dt at doses of ≥ 20 mg/kg/day as per the investigator's decision. * history of transfusion of at least 20 prbc units and anticipated to be transfused with at least 8 units of prbcs annually during the study * serum ferritin \> 1000 ng/ml, measured at screening visit 1 and screening visit 2 (the mean value will be used for eligibility criteria). key exclusion criteria: * creatinine clearance below the contraindication limit in the locally approved prescribing information. creatinine clearance will be estimated from serum creatinine at screening visit 1 and screening visit 2 and the mean value will be used for eligibility criteria. * serum creatinine \> 1.5 xuln at screening measured at screening visit 1 and screening visit 2 (the mean value will be used for eligibility criteria). * alt (sgpt) \> 5xuln, unless lic confirmed as \>10 mg fe/dw within 6 months prior to screening visit 1. * significant proteinuria as indicated by a urinary protein/creatinine ratio \> 0.5 mg/mg in a non-first void urine sample at screening visit 1 or screening visit 2. * patients with significant impaired gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral deferasirox (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). * liver disease with severity of child-pugh class b or c

Keywords: iron overload chelation thalassemia myelodysplastic syndrome (mds) transfusional hemisiderosis deferasirox icl670 dispersible tablet film-coated tablet
neoadjuvant chemotherapy with carboplatin and docetaxel in patients with advanced ovarian cancer-prospective, randomized phase ii clinical trial

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker ca 125). furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.


Eligibility criteria:
inclusion criteria: * histological confirmed ovarian neoplasm * figo stage iiic (2cm extrapelvic disease) or figo iv * more than 500 ml ascites volume (measured by sonography) * age \> 18 years old * ecog \<= 2 * adequate hepatological, renal and haematological function * informed consent exclusion criteria: * concomitant or previous malignant diseases * debulking procedures on initial surgical approach * existing peripheral sensoric neuropathy \>= grade 2 * acute infections * mental disorders, cerebral metastasis * bowel obstruction

Keywords: ovarian neoplasms, neoadjuvant therapy, docetaxel, neoplasm, residual
bradykinin-degradating enzymes activities in angiotensin-converting enzyme inhibitors-associated angioedema

Conditions: Angio-Oedema Caused by Angiotensin-Converting-Enzyme Inhibitor

Summary: angiotensin-converting-enzyme-inhibitors-dependent angioedema (acei-ae) is the most frequent form of bradykinin-mediated ae, with an estimated prevalence of 0.1% to 0.7%. these ae can be explained by the accumulation of bradykinin (bk), a peptide responsible for increase of vascular permeability: ace inhibitors block ace, the main inactivation pathway of the bk, thus extending its half-life. in spite of the the stopping of the drug, systematically performed in the case of acei-ae, up to 50% of patients relapsed within 6 months, with maximum risk in the first month after stopping. in addition, the discontinuation of these drugs represents a loss of chance for some patients, without clearly established mastocytic (or histaminic) or bradykinic etiology. at present there is no method to predict the risk of crisis recurrence in patients who have developed ae-iec. the investigators hypothesize that the risk of relapse is associated with a decrease in the activity of bk degradation enzymes (including aminopeptidase p (app), dipeptidyl peptidase-4 (dpp4), and eca) that persists at the cessation of iec.


Eligibility criteria:
inclusion criteria: * men and women at least 18 years old * presenting ae secondary to treatment with angiotensin conversion enzyme inhibitors for less than 15 days, or an isolated ae (without superficial hives), which lasts at least 15 hours, and whose diagnosis is validated by the expert committee, * having signed informed and written consent * and being affiliated with social security exclusion criteria: * patient who had one or more aes prior to iec * hereditary or acquired deficiency of c1 inhibitor * subject with known mutation of the f12 or plg gene subject in times of exclusion from another research involving the human person type 1 or 2 persons referred to in sections l1121-5 to l1121-8 of the public health code (pregnant woman, breastfeeding mother, person deprived of liberty, person subject to legal protection) subject that cannot be contacted in an emergency situation
a study of rapastinel as adjunctive therapy in major depressive disorder (rap-md-03)

Conditions: Depressive Disorder, Major

Summary: this study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (adt) in patients with major depressive disorder (mdd) who have a partial response to adt.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at visit 1 * have no more than partial response (\< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test. exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before visit 1 * lifetime history of meeting dsm-5 criteria for: 1. schizophrenia spectrum or other psychotic disorder 2. bipolar or related disorder 3. major neurocognitive disorder 4. neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study 5. dissociative disorder 6. posttraumatic stress disorder 7. mdd with psychotic features * significant suicide risk, as judged by the investigator.
suicidal risk factors associated with opioid analgesics use

Conditions: SNIIRAM Database

Summary: there is an increase in prescriptions for analgesics opioids and overdose mortality in france. in the united states, the consumption of opioid analgesics is associated with excess mortality, especially suicide. in france, the investigator team showed retrospectively a link between history of suicide attempt (sa) and use of analgesics in general elderly population. it is important to determine if there is a link between the prescription of opioid analgesics and suicide attempts, in a longitudinal study in general population. the originality of the project lies in: * the absence of a french epidemiological study on the link between opioid analgesics and suicide attempt / mortality despite the context of "opioid crisis", * taking into account the terms of consumption of care

main objective: to estimate the relative risk (odds ratio) of sa associated with exposure to opioid analgesics in a case-crossover design study secondary objectives: 1. to compare the profile of subjects who attempted suicide versus subjects who had an accidental drug intoxication with opioids vs subjects who did not attempt suicide or did not have an accidental overdose with opioid analgesics (case-control design) 2. to evaluate the dose-effect of opioid analgesics on the risk of sa (case-control and case-crossover design). 3. to identify changes in care consumption (medical consultations, co-prescriptions, changes in analgesic doses) in the 3 months preceding a sa in patients who received at least one prescription for opioid analgesics in the same period. the database is retrospective (2012-2017) two methods will be used -case crossover study (reference period of 3 months preceding the sa versus 3 control periods of 3 months without sa.- case control study (age and gender matching) case 1 = occurrence of a sa according to pmsi codes "x60 to x84" between the date of the first delivery of opioid analgesics recorded in the sniiram database since 2012 and december 2017; case 2 = subjects who had accidental drug intoxication with opioid analgesics according to pmsi code "t40"; controls = absence of sa and accidental opioid overdose

Eligibility criteria:
inclusion criteria: * adults \>18 years * having received at least one reimbursed delivery of an opioid analgesic (morphine, oxycodone, fentanyl, tramadol, codeine, or lamaline) over the period 2012-2017 (sniiram database). exclusion criteria: - refund of methadone or buprenorphine over the period 2012-2017 (sniiram database).

Keywords: suicide attempt analgesics opioid pharmacoepiemiology
effect of travoprost 0.004% on retinal oximetry in primary open angle glaucoma

Conditions: Primary Open Angle Glaucoma

Summary: glaucoma is the second leading cause of blindness among seniors in canada. it is often associated with an elevated intraocular pressure (iop), but its exact mechanism is still largely unknown. some studies have shown a link between glaucoma and changes in the amount of oxygen in the veins of the eye. the study aims to compare the amount of oxygen in ocular veins among three different groups using a spectrophotometer. this instrument is linked to a camera and can measure the quantity of oxygen in the veins using different characteristics of the blood inside. the groups of the study are: patients without glaucoma, patients suspected of glaucoma and patients newly diagnosed with glaucoma. the drug the investigators are using, travoprost 0.004%, will only be administered to the groups suspected or diagnosed with glaucoma. travoprost 0.004% is already approved for use in quebec and is part of standard care. ten patients will be recruited into each group for a total of 30 patients in this study. all patients for the suspected or diagnosed groups will be recruited from the jewish general hospital. subsequently all testing will be done at the école d'optométrie, université de montréal


Eligibility criteria:
inclusion criteria: * good systemic health * irido-corneal angle open * intraocular pressure more than 18 mmhg exclusion criteria: * having cardiovascular problem * hypertension or diabetes * under systemic medication for high blood pressure * had an ocular surgery in the past

Keywords: primary open angle glaucoma retinal oximetry
a phase ib study of fruquintinib in 3rd line mcrc

Conditions: Colorectal Cancer

Summary: fruquintinib is a novel oral small molecule compound discovered and developed by hutchison medipharma that selectively inhibits vascular endothelial growth factor receptors (vegfr) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts.based on first-in-human study, both 4mg qd and 5mg 3wks on/1wk off are safety and efficacy, this phase ib study is to evaluable the safety, tolerability and efficacy of these 2 regimens with mcrc failed 2nd therapy or more and to determine the recommended dose and regimen in phase ii/iii study.

this is a phase ib, randomize, interventional, open-label, multicenter study to provide fruquintinib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist. the primary endpoint of this study will be safety.

Eligibility criteria:
inclusion criteria: * ≥ 18 and ≤ 70 years of age , with ≥ 40kg * histological or cytological confirmed colorectal cancer * ecog performance status of 0-1 * standard regimen failed or no standard regimen available * adequate hepatic, renal, heart, and hematologic functions * at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan) * signed and dated informed consent. * willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure exclusion criteria: * pregnant or lactating women * any factors that influence the usage of oral administration * evidence of cns metastasis * intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure * abuse of alcohol or drugs * less than 4 weeks from the last clinical trial * previous treatment with vegfr inhibition * disability of serious uncontrolled intercurrence infection * proteinuria ≥ 2+ (1.0g/24hr) * uncontrolled hemorrhage in gi * within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc. * within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or cabg * bone fracture or wounds that was not cured for a long time * coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

Keywords: patients with mcrc who failed 2nd therapy or more