Kornimate/medical-research-clean huggingface dataset:
combination with gemcitabine in advanced pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: open-label, uncontrolled, phase i/ii study to evaluate safety and efficacy of bay86-9766 plus gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer. phase i: dose escalation study investigating 20, 30 and 50 mg bay86-9766 plus gemcitabine (1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose. phase ii: determination of response (recist 1.1; primary endpoint). secondary endpoints: response duration, disease control rate, time to progression, progression-free survival, overall survival, safety and tolerability. tumor assessments at screening and than every 8 weeks.; safety evaluations at screening and weekly throughout the study; safety follow-up visit 30 days after the last dose of study treatment; survival follow up monthly for up to 8 month after lpfv.


Eligibility criteria:
inclusion criteria: * male or female patients ≥18 years of age * histological or cytologically confirmed locally advanced, inoperable or metastatic pancreatic adenocarcinoma not amenable to curative radiotherapy or surgery * patients must have at least one uni-dimensional measurable lesion by ct or mri according to recist, version 1.1 * resolution of all acute toxic effects of any prior local treatment to common terminology criteria for adverse events (ctcae) grade \</= 1 * eastern cooperative oncology group performance status (ecog ps) \</= 2 * patient has cardiac function, within normal range, as measured by an echocardiogram exclusion criteria: * known history of, or symptomatic metastatic brain or meningeal tumors * history of cardiac disease * active clinically serious infections * clinically significant (ie. symptomatic) peripheral vascular disease * pregnant or lactating women; women of childbearing potential not employing adequate contraception * use of strong inhibitors or inducers of cyp3a4 * prior systemic therapy for metastatic or locally advanced, unresectable pancreatic cancer, or other malignancy * previous gemcitabine or 5-fluorouracil (5-fu) given concurrently as radiosensitizers to radiation therapy in adjuvant intention if given within 6 months from start of study treatment * thrombotic or embolic events such within 6 months prior to start of study treatment

Keywords: pancreatic cancer, mek-inhibitor
anemia and red blood cells transfusion in oncological surgery

Conditions: Anemia; Surgery; Oncology

Summary: oncologic patients experience anemia and anemia is associated with poor prognosis. transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. the primary objective of this study is to determine the impact of anemia and red blood cells (rbc) transfusion on post-operative complications and mortality.

between 36 and 75% of oncologic patients experience anemia and anemia is associated with poor prognosis. up to 40% of surgical oncologic patients receive red blood cells (rbc). however, transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. the primary objective of this study is to determine the impact of anemia and red blood cells (rbc) transfusion on post-operative complications and mortality. this is a retrospective, single center study. all adults admitted to the intensive care unit (icu) after oncologic surgery within the study period are eligible.

Eligibility criteria:
inclusion criteria: * surgery for cancer * admission to intensive care exclusion criteria: * no consent

Keywords: red blood cells transfusion
measuring changes in body composition and physical function in patients with childhood cancers

Conditions: Cancer; Malignant Neoplasm

Summary: the primary objective of this study is to evaluate the feasibility and acceptability of obtaining repeated measurements of lean muscle mass, physical function, and biological aging in children receiving active cancer therapy. the secondary objective is to evaluate the feasibility of using the d3-creatine dilution method (d3cr) to measure skeletal muscle mass in children with cancer. assessments will be collected at diagnosis, once during active treatment, and end of treatment in coordination with routine imaging to monitor changes in study outcomes during active cancer treatment. key sociodemographic, treatment and health-related factors will be abstracted from the medical record.


Eligibility criteria:
inclusion criteria in order to participate in this study a subject must meet all of the eligibility criteria outlined below. 1. ages 8-21 years at the time of cancer diagnosis 2. must have a newly diagnosed malignant solid tumor or lymphoma. 3. participant is expected to undergo cancer treatment with either chemotherapy, radiation, immunotherapy, or other biologically targeted therapy. 4. participants will undergo routine imaging with either computed tomography (ct), or magnetic resonance imaging (mri) of the chest or abdomen, or whole-body positron emission tomography (pet) scan. 5. written informed consent obtained to participate in the study and hipaa authorization for the release of personal health information. 6. english or spanish speaking 7. subject is willing and able to comply with study procedures. 8. since the patient is undergoing active cancer therapy, must obtain approval from the treating physician. exclusion criteria all subjects meeting any exclusion criteria at baseline will be excluded from study participation. 1. prior history of cancer 2. treatment with surgical excision alone 3. planned palliative treatment. 4. subject has elected to forgo chemotherapy or radiotherapy. 5. any diagnosis of leukemia. 6. clinical concerns that the treating clinician feels would preclude participation in the study. 7. subject has a pacemaker or bilateral joint prosthesis that would prevent undergoing bia assessment. 8. unwilling to sign informed consent. 9. speak a language other than english or spanish.

Keywords: d3-creatine dilution method pediatric muscle mass biological aging physical function
effectiveness of beclomethasone dipropionate nasal aerosol for perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis (PAR)

Summary: this study will be a prospective observational study of "real world" bdp nasal aerosol users with par, with or without seasonal allergic rhinitis (sar). subjects will respond to monthly online surveys regarding rhinitis control, concomitant medical conditions, concomitant (non-ar) medications, current ar therapy, and adverse events.


Eligibility criteria:
inclusion criteria: * male or female * age 12 years or greater at time of enrollment * diagnosis of par for at least one year; and 2)a positive skin prick (ie, epicutaneous) or serum-specific ige test within the past 2 years to a perennial allergen as appropriate for the location; and 3)par symptoms that are consistent with exposure to this allergen for at least one year * uncontrolled rhinitis symptoms at the time of assessment as confirmed by a score of 21 or less on the rcat * newly prescribed bdp nasal aerosol (within the past 7 days but have not yet used) * willing and able to complete surveys in english on a computer with internet access * willing and able to provide informed consent prior to entering the study (or parent/caregiver/legal guardian if applicable) exclusion criteria: * current acute or chronic sinusitis or chronic purulent nasal discharge * rhinitis medicamentosa or nasal structural abnormalities (including nasal polyps and clinically significant septal deviation) that significantly interfere with nasal airflow * acute upper respiratory infection within the past 14 days * used any pressurized metered-dose inhaler ins product (including bdp nasal aerosol and ciclesonide nasal aerosol) within the past 90 days * used any experimental therapy for ar within the past 30 days * any condition which the investigator feels may interfere with the study
the effect of exercise given to cashiers along with ergonomics training on pain and work performance

Conditions: Work-related Illness; Work Related Upper Limb Disorder

Summary: the aim of the study is to examine the effectiveness of the exercises given to cashiers through ergonomics training.

the work will be done with 60 cashiers. these cashiers will be selected on the condition that they work at least 40 hours a week. 60 employees will be randomly divided into two groups of 30 people each. all participants will be given ergonomics training. in addition, participants in the exercise group will be given a 12-week exercise program. these two groups will be randomly divided into control and exercise groups. each group will be evaluated twice, at the beginning and at the end of the study.

Eligibility criteria:
inclusion criteria * those who have been working as cashiers in the market for at least 2 years * employees who have no obstacle to exercise * women and men aged 18-45 * cashiers working 40 hours or more per week exclusion criteria * being diagnosed with a serious psychological illness. * malignancy * advanced osteoporosis * being under 25 years of age.
anti-cd19 car t infusion combined with allogeneic stem cell transplantation for b-cell leukemia/lymphoma

Conditions: B-cell Adult Acute Lymphoblastic Leukemia; B-cell Chronic Lymphocytic Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Hematopoietic/Lymphoid Cancer; Refractory Chronic Lymphocytic Leukemia

Summary: this is a single-arm open-label phase i study to determine the effect of cd19- car-t cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with cd19+ b-lineage leukemia and lymphoma.

primary objectives 1. to determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of t cells modified to express cd19-specific chimeric antigen receptor (cd19car) for treatment of leukemia and lymphoma secondary objectives 2. to measure the efficacy of the cd19car t cell infusion combined with allogeneic stem cell transplantation

Eligibility criteria:
inclusion criteria: * 5 years to 70 years, male and female; * expected survival \> 12 weeks; * performance score 0-2; * histologically confirmed as cd19-positive lymphoma/leukemia and who meet one of the following conditions; patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve cr; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; disease recurrence after stem cell transplantation; diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy * creatinine \< 2.5 mg/dl; * alt/ast \< 3x normal; * bilirubin \< 2.0 mg/dl; * adequate venous access for apheresis, and no other contraindications for leukapheresis; * take contraceptive measures before recruit to this trial; * written voluntary informed consent is given. exclusion criteria: * patients with symptoms of central nervous system * accompanied by other malignant tumor * active hepatitis b or c, hiv infection * any other diseases could affect the outcome of this trial * suffering severe cardiovascular or respiratory disease * poorly controlled hypertension * a history of mental illness and poorly controlled * taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration * occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment * reaching a steady dose if receiving anticoagulant therapy before assignment * female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * pregnant or lactating women * subject suffering disease affects the understanding of informed consent or comply with study protocol.
outcome of patients admitted with acute lower extremity ischemia

Conditions: Acute Ischemia of Lower Limb

Summary: acute ischemia of the lower limb (ami) is a life-threatening emergency that threatens the functional prognosis of the limb. depending on the clinical presentation and the anatomy of the patient, several therapeutic approaches can be considered: open surgery, endovascular surgery, hybrid surgery or amputation if revascularization is not feasible. the data in the current literature do not allow to clearly establish which therapeutic approach is the most adapted to the patient.


Eligibility criteria:
inclusion criteria: * age greater than 18 years, regardless of gender. * diagnosis of ami defined according to the rutherford classification (2). ami may involve one or both lower limbs. * be able to understand and give free and informed consent (non-opposition) to participate in the study * to be affiliated to the social security system * not to object to participating in the study (collection of non-objection) exclusion criteria: * voluntary discharge of the patient: opposition to the use of the data (withdrawal of the non-objection) * termination of the study by decision of the sponsor or investigator.
safety and immunogenicity of a commercially available influenza vaccine (formulation 2006/2007) when administered to subjects 18 years of age or older

Conditions: Influenza

Summary: the present study aims to evaluate safety and immunogenicity of one dose of a commercially available surface antigen, inactivated influenza vaccine, formulation 2006-2007, in non-elderly adult and elderly subjects.


Eligibility criteria:
inclusion criteria: * male and female subjects 18 years of age or older exclusion criteria: * any auto-immune disease or other serious acute, chronic or progressive disease * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine * known or suspected (or high risk of developing) impairment/alteration of immune function * within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy * history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine

Keywords: influenza influenza vaccine flu vaccination immunogenicity
project bipams: behavioral intervention for physical activity in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with ms. the investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. the investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. the investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.


Eligibility criteria:
inclusion criteria: * diagnosis of ms * relapse free in the past 30 days * internet and email access * willingness to complete the questionnaires, wear the accelerometer, and undergo randomization * being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months * ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair) * age between 18 and 64 exclusion criteria: * moderate or high risk for undertaking strenuous or maximal exercise per participants response to the par-q. those who report no more than one yes or affirmative on the 7 item par-q will be considered at low risk and included for participation. all others will be considered at moderate or high risk and excluded from participation.
clinical efficacy of pro-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the clinical efficacy of the ophthalmic solution pro-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis.

allergic conjunctivitis is inflammation of the tissue lining the eyelids (conjunctiva) due to a reaction from allergy-causing substances. the main aim in allergic conjunctivitis is to improve the quality of life in these patients. antihistaminic medication is commonly used to treat allergic conjunctivitis symptoms. the aim of the study is to compare the clinical efficacy of two ophthalmic solutions containing each one an antihistaminic drug. a phase iii randomized double-blind clinical trial will be conducted to evaluate efficacy of the ophthalmic solution pro-118 compared with olopatadine hydrochloride ophthalmic solution in allergic conjunctivitis. patients will be randomized to receive one of the treatments for 21 days. efficacy endpoints will be measured at baseline and at 21 days after treatment.

Eligibility criteria:
inclusion criteria: * provide informed consent * allergic conjunctivitis diagnosis * both genders * age between 6 and 60 years * patients with no treatment 2 years prior to study inclusion exclusion criteria: * patients with one blind eye * visual acuity \< 20/40 in any eye * patients with any active ocular disease that would interfere with study interpretation * patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol * patients with: diabetes mellitus, rheumatoid arthritis, hypertension, or any type of cancer * patients with history of hypersensitivity or contraindication for any drug used in the study * patients receiving systemic or topical treatment based on antihistamines, corticosteroids or immunomodulators * pregnant patients, at risk of pregnancy or breastfeeding * patients without birth control treatment * patients who had participated in any clinical trial in the last 90 days
effect of liraglutide on epicardial fat in subjects with type 2 diabetes

Conditions: Type 2 Diabetes; Overweight; Obesity

Summary: the purpose of this research study is to learn about the effect of liraglutide, (victoza®), on the fat surrounding the heart.excessive amount of the fat around the heart is common in people with type 2 diabetes and can be associated with poor sugar control. liraglutide is an injectable prescription medicine that can improve blood sugar control in adults with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, as defined by ada criteria * hba1c \< 8% measured at least 1 month prior to this study * bmi ≥27 kg/m2 * pre-treatment with metformin * age \> 18 and \< 65 years old exclusion criteria: * • known contra-indications to liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of men, in accordance with risks and safety information included in the latest updated prescribing information for victoza® * type 1 diabetes, as defined by american diabetes association (ada) criteria * insulin dependent or treated type 2 diabetes * current use of other injectable incretins * history of diabetes ketoacidosis * advanced chronic kidney disease, as defined by glomerular filtration rate (gfr) \< 30 ml/min/1.73m2 * clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure * clinical or laboratory evidences of chronic active liver diseases * acute or chronic infective diseases * cancer or chemotherapy * current use of systemic corticosteroids or in the 3 months prior this study * known or suspected allergy to liraglutide, excipients, or related products * pregnant, breast-feeding or the intention of becoming pregnant * females of childbearing potential who are not using adequate contraceptive methods

Keywords: epicardial fat type 2 diabetes obesity glp-1 analogs
effect of contouring techniques on cmr assessment of the right ventricle in repaired tetraology of fallot

Conditions: Tetralogy of Fallot

Summary: patients with repaired tetralogy of fallot (rtof) develop chronic pulmonary regurgitation and require monitoring for right ventricular dilatation. pulmonary valve replacement can prevent irreversible right ventricular (rv) dilatation and dysfunction and cardiac magnetic resonance (cmr) is used to facilitate its optimal timing. the investigators sought to determine whether the choice of myocardial contouring technique affects preoperative rv volumetric thresholds for intervention.

participants with repaired tetralogy of fallot (rtof) will be identified using existing patient electronic records who have developed chronic pulmonary regurgitation and are undergoing monitoring for right ventricular dilatation. cardiac magnetic resonance (cmr) is used to facilitate its optimal timing. pulmonary valve replacement can prevent irreversible right ventricular (rv) dilatation and dysfunction and cardiac magnetic resonance (cmr) is used to facilitate its optimal timing. there are different post-processing techniques published for measuring rv volumes on cardiac magnetic resonance imaging (detailed vs. smoothed and manual vs. automated). the primary aim of this study is to identify whether the choice of myocardial contouring technique affects the preoperative rv volumetric thresholds for intervention. as a secondary aim, the investigators will determine the reproducibility of different contouring methods.

Eligibility criteria:
inclusion criteria: * consecutive patients with repaired tetralogy of fallot undergoing routine clinical surveillance at a level 1 achd surgical referral centre. exclusion criteria: * none
proteomic and metabolomic lacrimal fingerprint in diverse pathologies of the ocular surface

Conditions: Dry Eye Syndrome; Infectious Keratoconjunctivitis; Mucous Membrane Pemphigoid; Allergic Conjunctivitis

Summary: this study aims to obtain the lacrimal fingerprint for frequent pathologies of the ocular surface and establish a normative base for each of them.

this is an exploratory study. the investigators aim to: * test and perfect a tear sample analysis technique by mass spectrometry with samples collected by schirmer strips; * obtain the lacrimal fingerprint for various pathologies of the ocular surface, notably different forms of dry eye syndrome, infectious keratitis/conjunctivitis, mucous membrane pemphigoid and allergic conjunctivitis, and establish a normative base for each of them. during regular clinics at the cornea service of the ophthalmology department of the chum (centre hospitalier de l'université de montréal), the investigators aim to recruit a few hundred patients with various pathologies of the ocular surface, notably different forms of dry eye syndrome, infectious keratitis/conjunctivitis, mucous membrane pemphigoid and allergic conjunctivitis, and collect a sample of their tears via schirmer strip. a case report form will be completed for each patient, noting known ocular diagnoses and active topical ophthalmic medication. schirmer strips will be sent in sterile tubes to uqam (université du québec à montréal)'s department of chemistry for analysis by mass spectrometry.

Eligibility criteria:
inclusion criteria: * patients with healthy corneas or suffering from one of these pathologies: dry eye syndrome; infectious keratitis and/or conjunctivitis; mucous membrane pemphigoid; allergic conjunctivitis. exclusion criteria: * patients younger than 18 years old; * patients incapable of giving informed consent.

Keywords: lacrimal fingerprint metabolomics proteomics ocular surface