Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of ro7790121 for induction and maintenance therapy in participants with moderately to severely active ulcerative colitis

Conditions: Moderately to Severely Active Ulcerative Colitis

Summary: this phase iii, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of ro7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of uc * moderately to severely active uc assessed by mms * bodyweight \>= 40 kilogram (kg) * up to date with colorectal cancer (crc) screening performed according to local standards * demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced uc therapy * males and females of childbearing potential must meet protocol criteria for contraception requirements exclusion criteria: * currently known complications of uc (e.g. fulminant colitis, toxic megacolon) * current diagnosis of crohn's disease (cd) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis * presence of an ostomy or ileoanal pouch * current diagnosis or suspicion of primary sclerosing cholangitis * pregnancy or breastfeeding, or intention of becoming pregnant during the study * past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed * history of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer * evidence of infection with clostridioides difficile (c. difficile; formerly known as clostridium difficile), cytomegalovirus (cmv), human immunodeficiency virus (hiv), hepatitis b (hbv), hepatitis c (hcv) * has evidence of active tuberculosis (tb), latent tb not successfully treated (per local guidance) or inadequately treated tb * has received protocol-specified prohibited medicines, including known exposure to any type of anti-tl1a therapy
evaluation of emergency department (ed) staff stress level during covid-19 pandemic

Conditions: Emergency Department Staff During the COVID-19 Pandemic; Emergency Department Staff's Level of Stress

Summary: in the context of the covid-19 pandemic, emergency department (ed) are in front line for the reception of patients presenting covid-19 symptoms and have to face a new situation given the expected number of patients. staff participate in suspect patients triage, in the diagnosis and the management of covid-19 patients, having to follow the instructions and recommendations that evolve in real time, depending on the stage, resources and means available. this situation requires that the staff immediately adaptation within this reorganization and redeployment of the activity. then; they are subject to many stress and anxiety factors such as: * increased activity: massive influx of patients, overload of work, lack of material and human resources * modification of practices: training in procedures, measures isolation and prevention of contamination of other patients, replacement by professionals reassigned from other departments * ethical dilemma: decisions to be made in an emergency, patient prioritization * numerous, evolving information, from various sources and sometimes contradictory (national, governance, service, media) * individual: fear of personal contamination and of those close to you, personal organization in a situation of confinement of the population, loss of usual social support * anxiety and stress management of patients and relatives, their entourage and colleagues in this study, it is proposed to study the psychic impact of the covid-19 pandemic on emergency department staff.


Eligibility criteria:
inclusion criteria: * adults * medical and paramedical staff working the the emergency room permanently or specifically during the covid19 pandemic * not opposed to participate to this study exclusion criteria: * staff under legal protection * refusing to participate

Keywords: covid-19 pandemic level of stress emergency department staff
diagnostic procedure for identifying patients with metastatic colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: rationale: diagnostic procedures, such as lymphography, may improve the identification of patients with metastatic colorectal cancer. purpose: clinical trial to study the effectiveness of lymphography in determining the presence or absence of metastatic colorectal cancer in patients.

objectives: i. confirm that injection of isosulfan blue into the mucosa or serosa immediately adjacent to a colorectal cancer results in the lymphatic transport of that agent initially to a specific regional lymph node that can readily be identified on visual inspection, dissected, and histologically evaluated for the presence or absence of metastatic disease. outline: all patients receive an injection of isosulfan blue into peritumor serosa upon intraoperative identification of the primary tumor, prior to mesenteric mobilization. if colonoscopy is otherwise indicated, the injection may be delivered to the peritumor mucosa via colonoscopy during the case. the mesentery adjacent to the injection is inspected and the lymphatic pattern and nodes demonstrated by the isosulfan blue are diagrammed and photographed. the sentinel node(s) are surgically dissected and evaluated. if needed, a second injection of isosulfan blue may be given. prior to mobilization of liver for resection of metastases, isosulfan blue is injected subcapsularly around the metastatic lesion. projected accrual: there will be 10 patients accrued into this study.

Eligibility criteria:
disease characteristics: patients must be undergoing surgical resection of a colorectal primary adenocarcinoma metastatic colorectal cancer to liver (hepatic metastases) allowed patient characteristics: age: 18 to 75 performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: no known or suspected allergy to isosulfan blue not pregnant prior concurrent therapy: see disease characteristics

Keywords: stage i colon cancer stage ii colon cancer stage iii colon cancer stage iv colon cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer adenocarcinoma of the colon liver metastases
oral topotecan as a radiosensitizing agent in rectal cancer

Conditions: Carcinoma, Renal Cell

Summary: patients with rectal cancer who are candidates for pre-operative radiation therapy may be enrolled in the phase i, single center study. patients will have a full blood count, biochemistry, urinalysis, and ecg for safety evaluation. sequential cohorts of three patients will be given increasing doses of oral topotecan and fixed doses of concurrent radiation (45 gy) over five weeks. the starting dose of oral topotecan is 0.25 mg/m2 to be concomitantly administered with radiation (45 gy) x 5 days every week unless the radiation is interrupted for holidays/weekends or toxicity requiring treatment delays occurs. a total of 25 doses are planned.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed rectal cancer. * candidates for preoperative radiotherapy. * primary tumor at least 3cm and clinical stage of t2, t3, or t4 and any n according to the astler-coller modification of the dukes staging system. * eastern cooperative oncology group (ecog) performance status less than 2. * diagnosis of rectal cancer should be no more than 90 days from start of therapy. * evaluation at the h. lee moffitt cancer center. * recovery from prior surgery and life expectancy at least 3 months. exclusion criteria: * a primary tumor totally excised. * recurrent rectal cancer that failed initial treatment. * exposure to topotecan, infection, immunodeficiencies, conditions of the gastrointestinal (gi) tract which would affect absorption, medication that maintains motility/gastric emptying. * any concomitant malignancy within the last five years. * severe medical problems unrelated to the malignancy which would limit compliance with the study. * patients of child bearing potential. * not practicing adequate contraception. * patients who are pregnant or lactating. * use of an investigational drug within 30 days or 5 half-lives of the first dose.

Keywords: oral topotecan rectal cancer pelvic radiation
lovaza therapy of peripheral arterial disease

Conditions: Peripheral Artery Disease

Summary: sixty patients with mild-to-moderate pad (abi 0.4-0.9) and hypertriglyceridemia (\>200 mg/dl) already treated with statins will be imaged at baseline and randomized to lovaza and placebo for 12 months. mr imaging will be repeated at the end of the 12-month period. we hypothesize that treatment of hypertriglyceridemia in patients with pad with lovaza will reduce atherosclerotic plaque volume in the superficial femoral artery (sfa) by 2% over 1 year compared to placebo. secondary aims will be to show improved plaque characteristics (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle perfusion using first-pass contrast enhanced mri and improved exercise treadmill performance with lovaza compared to matching placebo.


Eligibility criteria:
inclusion criteria: * male or female, any ethnicity, ages 55-75 * mild to moderate pad (ankle brachial index (abi) of 0.4-0.9 in either or both limbs) * symptomatic intermittent claudication in either or both limbs * hyperlipidemia treated with hmg-coa reductase inhibition with persistent hypertriglyceridemia (triglycerides\>200). exclusion criteria: * patients with critical limb ischemia * moderate to severe chronic kidney disease (requiring hemodialysis or glomerular filtration rate (gfr) \< 45 ml/min) * contraindication to mri (pacemakers, defibrillators, intraocular metal, certain intracerebral aneurysm clips, etc.) * claustrophobia * known allergy to gadolinium chelates * patients with iron storage disease

Keywords: pad peripheral artery disease
ivacaftor (kalydeco) and insulin in cystic fibrosis (cf)

Conditions: Cystic Fibrosis Related Diabetes; Cystic Fibrosis

Summary: this study is aimed at better understanding the impact of ivacaftor upon insulin and incretin secretion and glucose tolerance in patients with cystic fibrosis with a glycine (g551d) mutation. investigators hypothesize that treatment with ivacaftor improves insulin secretion in individuals with cf.

cystic fibrosis related diabetes (cfrd) is associated with worse nutritional status, greater pulmonary function decline, and increased mortality, highlighting its relevance in cystic fibrosis (cf). cfrd arises primarily from compromised insulin secretion - traditionally considered a by-product of pancreatic exocrine tissue damage and fibrosis. recent developments in the field of diabetes are propelling a re-examination of this basic explanation. the impact of the cystic fibrosis transmembrane conductance regulator (cftr) potentiator, ivacaftor, upon insulin secretion and glucose regulation has not been examined, but improved glucose tolerance has been appreciated anecdotally. this study aims to understand the impact of ivacaftor therapy upon blood glucose and insulin and incretin secretion.

Eligibility criteria:
inclusion criteria: * 6 yrs or older with cystic fibrosis * at least one g551d cftr mutation or other non-g551d gating mutation, or residual function cftr mutation such as, but not limited to, r117h mutation, for which ivacaftor is to be initiated. * plan to initiate ivacaftor treatment for fda approved indications by clinical care team or as part of an ongoing study of ivacaftor for other cftr mutations, including gating mutations, or residual function mutations. * not pregnant exclusion criteria: * established diagnosis of non-cf related diabetes (ie., type i diabetes) * history of clinically symptomatic pancreatitis in past year * prior lung or liver transplant * severe cf liver disease * fundoplication-related dumping syndrome * medical co-morbidities that are not cf-related or are unstable per the investigator opinion * acute cf pulmonary exacerbation within 4 weeks prior to study procedures * treatment with oral or intravenous corticosteroids within 4 weeks of study * hemoglobin \<10g/dl within 90 days of gpa test or at screening * abnormal renal function within 90 days of gpa test or at screening * long-standing cfrd with fasting hyperglycemia, elevated hba1c (\>8) beyond time surrounding diagnosis of cfrd, significant basal insulin requirement * inability to perform study specific procedures (mmtt, gpa).

Keywords: cystic fibrosis cf cystic fibrosis related diabetes cfrd kalydeco ivacaftor
prognostic value of elevated troponins in critical illness study: a pilot study

Conditions: Troponin; Critical Care; Myocardial Infarction

Summary: troponins are sensitive and specific markers of cardiac injury. critically ill patients frequently have elevated troponins. in this population, distinguishing patients with elevated troponins from those with myocardial infarction is difficult. however, troponin elevations on their own seem to be associated with an increased risk of death. the optimal treatment of patients with type 2 myocardial infarction or non ischemia related troponin elevations during critical illness is unclear. there are no trials in the icu setting to guide management. this study is a 1-month pilot cohort study of troponin screening in 4 ontario intensive care units. the objective of this pilot study is to evaluate the ability to perform a larger study, which will determine the prevalence, incidence and risk factors for elevated troponin values, how patients with elevated troponin values are treated as a baseline, and the incidence of myocardial infarction in critically ill patients. knowing the prognostic impact of these conditions and understanding current management will thereafter guide researchers and clinicians on the importance of carefully evaluating potential risk-modifying therapies.


Eligibility criteria:
inclusion criteria: * all adult patients admitted to the participating icus of study sites during the study enrollment period will be eligible. exclusion criteria: * patients who are admitted and die or are discharged within 12 hours * patients re-admitted to icu during the index icu enrolment month

Keywords: troponin biomarkers myocardial infarction critical illness
rotational atherectomy: long-term results from a single center experience

Conditions: Ischemic Heart Disease; Acute Coronary Syndrome

Summary: the ra-bia registry is a single-center observational study. the study included consecutive patients from 2008 who met inclusion criteria and were treated with ra. the main aim of the study is to assess the efficacy of rotational atherectomy.

severe coronary artery calcifications occur in about 10% of patients undergoing percutaneous coronary intervention (pci). they constitute a strong independent predictor of an adverse cardiovascular event. even though the risk factors and pathomechanisms leading to severe coronary calcification are well understood, the options for effective treatment remain insufficient. in the presence of severe calcification, standard pci has inferior immediate and long-term outcomes. in this situation, advanced lesion modification techniques are indispensable to improve pci outcomes. dedicated balloons and essentially ablative techniques are available. rotational atherectomy (ra) is the oldest and best-recognized ablative technique. it is generally acknowledged that superficial modification of calcified atherosclerotic lesions is an optimal mechanism of action in ra. the ra-bia registry is a single-center observational study. the study included consecutive patients from 2008 who met inclusion criteria and were treated with ra. the main aim of the study is to assess the efficacy of rotational atherectomy. the primary endpoints were device-oriented composite endpoint (doce) (defined as a composite of cardiac death, tlr, and target vessel mi), tvr, mi, and cardiac death. tvr and tlr were defined according to the definitions of endpoints for clinical trials. the secondary endpoints were the clinical success rate of the ra procedure (defined as successful revascularization of all treated lesions and the incidence of in-hospital complications including coronary perforation, coronary dissection, coronary low flow or no flow, emergency cabg, tamponade, mi, stroke or transient ischemic attack (tia), bleeding events (according to the bleeding academic research consortium \[barc\] classification and death.

Eligibility criteria:
inclusion criteria: 1. patient ≥ 18 years old 2. lesions in target vessels requiring ra 3. patient accepting the appropriate follow-up as per study definition exclusion criteria: 1. patient age \< 18 years 2. patients who previously participated in this study. 3. pregnant and/or breastfeeding females or females who intend to become pregnant. 4. unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) . 5. the subject has an allergy to imaging contrast media which cannot be adequately pre-medicated.

Keywords: rotational atherectomy rotablation
low dose radiation therapy for glioblastoma multiforme

Conditions: High Grade Glioma

Summary: to evaluate the safety and effectiveness of low dose rate radiation therapy plus temozolomide. this will be in patients with high grade glioma (to only include anaplastic astrocytoma or glioblastoma multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.

in vitro and in vivo studies have suggested that low dose fractionated radiation therapy (ldfrt) may be used to potentiate full dose chemotherapy, decreasing the development of resistance found with standard doses of radiation and chemotherapy. this is a nonrandomized, open label, single institution phase ii trial with a safety run-in to evaluate the safety and efficacy of ldfrt plus temozolomide in patients with high grade glioma (to only include anaplastic astrocytoma or glioblastoma multiforme) previously treated with surgical resection followed by adjuvant radiation therapy plus temozolomide. the primary objective of the phase ii study is to estimate response rate in patients treated with twice daily fractions of low dose radiation plus temozolomide chemotherapy.

Eligibility criteria:
inclusion criteria: * patients must have recurrent gbm (glioblastoma multiforme)or anaplastic astrocytoma. * the diagnosis of gbm or anaplastic astrocytoma. * patients must have been previously treated with surgical resection (any extent okay) and adjuvant radiation therapy plus temozolomide. * patients must be at least 12 months from completion of radiation therapy * at least 2 months from completion of temozolomide (to be consistent with the the "rechallenge" group from perry et al. jco 2010). * age \>18 years * ecog performance status \ 60%, see appendix a). * there must be measurable disease on mri. * patients must have normal organ and marrow function as defined below: * women must not be pregnant * ability to understand and the willingness to sign a written informed consent document * temozolomide re-treatment is planned by the treating neuro-oncologist. * the most recent brain tumor pathology obtained for the patient must be glioblastoma. exclusion criteria: * must be able to receive an mri * patients may not be receiving any other investigational cancer treatment agents at the time of enrollment. * patients may not have previously failed treatment with salvage temozolomide. * patients may not have previously failed treatment with a vegf inhibitor. * patients may not have previously been treated with \>1 course of radiotherapy. * patients may not have previously been treated with radiosurgery to the brain. * uncontrolled intercurrent illness * pregnant and breastfeeding women are excluded. women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. male subjects must also agree to use effective contraception for the same period as above.

Keywords: recurrent glioblastoma multiforme recurrent anaplastic astrocytoma surgery adjuvant radiation adjuvant temozolomide
usual care intervention research evaluating the impact of a personalized pharmaceutical plan on the duration of opioid treatment in non-cancerous pain

Conditions: Non-cancerous Pain; Opioid Use

Summary: many treatments with who grade iii opioids are being introduced in the rheumatology department for non-cancerous pain. the duration of this treatment prescribed at discharge is often uncontrolled and sometimes leads to significant addiction. the team at the local pain center recommends an average duration of 28 days for this type of pain. there is a full-time pharmacy intern in the rheumatology department. the aim of this work is to evaluate the impact of a targeted pharmaceutical interview on the duration of the morphine treatment initiated during hospitalization.


Eligibility criteria:
inclusion criteria: * age ≥ 18 and \< 75 years old when entering the rheumatology department * hospitalization in the rheumatology department * patient with acute non-traumatic musculoskeletal disease * patient not taking grade iii opioid treatment * patient affiliated to a social security scheme * patient having read and understood the information letter and signed the consent form * patient present on a day which the pharmacy intern is present exclusion criteria: * presence of cancer, fibromyalgia, already diagnosed at inclusion * patient does not understand french * patient with current or past opioid addiction * person deprived of liberty by administrative or judicial decision
idiotype vaccine after chemotherapy & stem cell transplantation in lymphoma with failed induction chemotherapy

Conditions: Lymphoma

Summary: this is a compassionate use protocol for participants who failed induction chemotherapy + vaccine on previous trials. these participants then went on to high dose beam chemotherapy and transplant, then received idiotype vaccine therapy at 3 months post transplant. vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. participants were then followed annually until progression or death with standard staging.

this trial was made available as a compassionate use protocol for participants who failed induction chemotherapy + vaccine on trials 0197-99-fb and 0196-99-fb. these follicular nhl participants then went on to high dose beam chemotherapy and transplant. patients received idiotype vaccine therapy at 3 months post transplant. vaccine was given monthly x 4 series, with a fifth series given 12 weeks after the fourth. participants are then followed annually until progression or death with standard staging. immune response testing continues annually on participants who continue to have a response post transplant.

Eligibility criteria:
inclusion criteria: * histologically confirmed aggressive or indolent, b-cell non-hodgkins lymphoma * original enrollment in vaccine protocol for newly diagnosed lymphoma and had successful production of idiotype vaccine * failed to achieve pr or cr with initial induction chemotherapy, received salvage chemotherapy and then stem cell transplant and achieved a cr or good pr following transplantation -\>/= 19 years * signed informed consent * non-pregnant, non-lactating exclusion criteria: * serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.