Kornimate/medical-research-clean huggingface dataset:
mfolfirinox with or without stereotactic body radiotherapy in locally advanced pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma; Pancreatic Cancer Non-resectable

Summary: modified folfirinox (mfolfirinox) is the standard of care for patients with locally advanced pancreatic adenocarcinoma. while radiotherapy has been investigated for the management of resectable or locally advanced pancreatic adenocarcinoma, its role in the era of modern chemotherapy is not clear. stereotactic body radiotherapy (sbrt) is the novel technique of radiotherapy to enhance the dose of radiotherapy to the target tumor lesion. this trial aims to compare the efficacy and safety of mfolfirinox with or without sbrt in patients with locally advanced pancreatic adenocarcinoma


Eligibility criteria:
inclusion criteria: * informed consent * age 19 years or greater * cytologically or histologically confirmed pancreatic adenocarcinoma * locally advanced unresectable disease per national comprehensive cancer network resectability criteria * no active infection except chronic hepatitis on anti-viral therapy * eastern cooperative oncology group performance status 0 or 1 * body weight \> 30 kg * normal organ and bone marrow function exclusion criteria: * gastrointestinal obstruction * active gastrointestinal bleeding or ulcer * clinically significant cardiac disease or myocardial infarction within 6 months before the randomization * histology other than adenocarcinoma (adenosquamous or neuroendocrine tumors) * pregnancy or breastfeeding

Keywords: pancreatic adenocarcinoma locally advanced unresectable mfolfirinox stereotactic body radiotherapy
improving antihypertensive and lipid-lowering therapy

Conditions: Hyperlipidemia; Hypertension

Summary: the purpose of this study is to evaluate the impact of electronic health record clinical decision support and automated telephone outreach on antihypertensive and lipid-lowering therapy in ambulatory care.

the quality of care delivered in physicians' offices is suboptimal. underuse of proven, potentially life-saving medications, such as anti-hypertensive agents and statins for lipid-lowering, is unfortunately no exception. data from more than 70 million people collected for the 2005 hedis report card show that fewer than half of those patients at high risk for myocardial infarction have adequately controlled lipids and fewer than 70% of patients with hypertension have blood pressure controlled; annually this suboptimal treatment accounts for more than 10,000 avoidable deaths, $333 million in avoidable hospital costs, 27.2 million sick days and $4.5 billion in lost productivity. the "care-gaps" in the management of blood pressure and lipids arise from numerous barriers to optimal practice at the level of the system, the provider, and the patient. process evaluations of quality improvement efforts have cited several barriers as the most important: inadequate time, resources, and support; limitations in computer technology, including insufficient information management; little use of formal change processes; too many competing priorities; a lack of agreement about the desired changes; and inadequate physician engagement. both computerized clinical decision support (cds) in the context of a robust electronic health record (ehr) and automated telephone outreach to patients with interactive voice recognition (ivr) to patients are promising interventions to overcome the barriers that physicians and patients encounter in treating hypertension and hyperlipidemia. while recent studies have begun to demonstrate the effectiveness of cds in the ambulatory setting, there is an urgent need to implement and evaluate these systems in the practices of physicians practicing solo or in small groups in the community, outside the extensive hit infrastructure of academic medical centers and integrated delivery systems. ivr is a patient-outreach intervention that involves automated telephone calls to patients to patients in a conversation about specific health-related issues. randomized control trials (rcts) have shown that ivr monitoring with clinician follow-up can improve self-care, perceived health status, and physiologic outcomes among individuals with diabetes and hypertension. the specific aim of this project is to evaluate, the effectiveness of cds alone compared to ivr to improve the use of antihypertensive and lipid-lowering medications in community-based primary care practices.

Eligibility criteria:
inclusion criteria: * mds, nps, pas, or dos practicing in primary care or medical subspecialties and using eclinical works ehr * patients of eligible physicians who have hypertension or hyperlipidemia

Keywords: clinical decision support systems hyperlipidemia hypertension
pico-salax colonic preparation study: quantifying electrolyte and volume status changes

Conditions: Hemodynamics; Hyponatremia

Summary: twenty adult volunteers will be administered pico-salax in the usual fashion for colonoscopy with intense monitoring of serum and urine chemistry and hemodynamics.


Eligibility criteria:
inclusion criteria: * healthy volunteers older than 45 exclusion criteria: * impaired renal function * congestive heart failure ascites known electrolyte abnormalities

Keywords: colonoscopy preparation
differentiated thyroid cancer patients treated with different doses of radioactive iodine.

Conditions: Thyroid Cancer

Summary: 1. determine the frequency of utilizing single and multiple doses of radioactive iodine (rai) in treatment of differentiated thyroid cancer. 2. asses the impact of various doses of radioactive iodine on the management of differentiated thyroid cancer. 3. investigate the influence of thyroid cancer on the quality of life of affected patients.

differentiated thyroid cancer represents more than 90% of cancer thyroid \[1\]. total thyroidectomy is considered the mainstay of curative therapy, with radioactive iodine (rai) in order to ablate or treat remnant thyroid tissue in the surgical bed and/or elsewhere \[2\]. the two main objectives for treatment of differentiated cancer thyroid are reducing the probability of cancer recurrence and facilitating serological surveillance via thyroglobulin (tg). the 2015 american thyroid association (ata) guidelines as well as european consensus conference described three main risk stratification for thyroid cancer including: low, intermediate and high risk \[3\] \[4\]. according to the 2015 ata guidelines, low- dose (1110 mbq) 131i ablation is recommended for low-to- intermediate-risk patients, while high-dose (3700 mbq or more) 131i ablation may be required for high-risk patients to remove microscopic residual disease(4). the optimal rai activity needed to achieve the best objective rai response and to minimize rai specific adverse effects is not known since there are many factors that should be considered while determining the dose including age of the patient and many pathological factors \[5, 6\]. therefore, dose adjustment might be needed for patients with same risk classification. just following the guidelines might not be optimal for treatment of individual differentiated thyroid cancer \[5\]. accordingly, in our centre the administrated activities are varied among our clinicians. in this study, we aim to retrospective analyse patients with differentiated thyroid cancer received variable (single and multiple) doses of rai in each risk group and to assess their clinical outcome. as thyroid cancer has a very good prognosis, there a debate that quality of life may be affected in patients with high risk compared to low and intermediate risks. additionally, we intend to evaluate the impact of thyroid cancer on quality of life by questionnaire filled by patients with different risk groups.

Eligibility criteria:
inclusion criteria: * • patients with differentiated cancer thyroid either papillary or follicular underwent total thyroidectomy with or without lymph node dissection. * available data of patients' records. exclusion criteria: * • missed follow up data.
neurostimulation and mirror therapy in traumatic brachial plexus injury

Conditions: Chronic Pain

Summary: traumatic injuries of the brachial plexus cause sufficient weakness to affect the individual in its various aspects, limiting the execution of activities of daily living, leading to highly disabling, and often definitive, clinical conditions with serious socioeconomic consequences. it causes motor, sensory and autonomic deficits, directly compromising the quality of life and functional performance of these individuals. it is a complex condition, whose recovery is usually slow and costly, in addition to often requiring surgery and rehabilitation. among the therapeutic possibilities, the non-invasive neuromodulation techniques stand out, especially the transcranial direct current stimulation (etcc) and the mirror therapy (et). in this context, the present study aims to analyze the effectiveness of the etcc technique combined with et in the treatment of patients with pain due to trauma to the brachial plexus, investigating the degree of improvement in pain intensity, functionality, quality of life and mood of these patients, comparing the onset with immediately after applying the techniques.

for this, a pilot clinical trial, placebo-controlled, blind and randomized, will be carried out, involving patients with traumatic brachial plexus injury, submitted to sessions of etcc and mirror therapy. participants will be randomly allocated to 1 of 2 groups: the first will receive active etcc associated with te and the second will receive simulated etcc in conjunction with te. the study will consist of 12 sessions, conducted over a period of 1 month, with 3 sessions weekly on consecutive days, where each patient will receive etcc for 30 minutes concomitantly with et. assessments will be performed before the beginning of the protocol (baseline) and immediately after the end of the 12 sessions. the tct-research device, developed by trans cranial technologies ltda for etcc and a rectangular platform with the dimensions of 40x70 cm, with a mirror sagittally coupled to the te will be used. to assess the outcomes, eva, mcgill's questionnaire, bpi, bdi, idate, sf-36 and cif will be applied. for all analyzes, the statistical software spss (spss inc, chicago il, usa) for windows, version 20.0, will be used and considered significant, an alpha value of 5% (p \<0.05).

Eligibility criteria:
inclusion criteria: * age over 18 years; * score of 4 to 10 points on the visual analogue scale; * persistent pain and refractory to clinical treatment for at least 3 months; * appropriate pharmacological treatment for pain for at least 1 month before the start of the study. exclusion criteria: * patients with other neurological diseases; * past history of substance abuse; * contraindications for etcc.
a clinical research of bcma-targeted prime car-t cell therapy in relapsed/refractory multiple myeloma and plasma cell disease

Conditions: Multiple Myeloma; Neoplasm, Plasma Cell; Multiple Myeloma in Relapse

Summary: this is a single arm study to evaluate the efficacy and safety of bcma-targeted prime car-t cells therapy for patients with relapsed/refractory multiple myeloma.

there are limited options for treatment of relapse/refractory multiple myeloma. bcma is expressed on most multiple myeloma cells so it is an ideal target for car-t. in this study, investigators will evaluate the safety and efficacy of prime car- t targeting bcma in patients with relapsed/refractory multiple myeloma. the primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent; 2. diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions: 1. failed to standard chemotherapy regimens; 2. relapse after complete remission, high-risk and / or refractory patients ; 3. relapse after hematopoietic stem cell transplantation; 3. evidence for cell membrane bcma expression 4. all genders, ages: 18 to 75 years# 5. the expect time of survive is above 3 months; 6. kps\>60 7. no serious mental disorders ; 8. left ventricular ejection fraction ≥50% 9. sufficient hepatic function defined by alt/ast≤3 x uln and bilirubin≤2 x uln; 10. sufficient renal function defined by creatinine clearance≤2 x uln; 11. sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. with single or venous blood collection standards, and no other cell collection contraindications; 13. ability and willingness to adhere to the study visit schedule and all protocol requirements. exclusion criteria: 1. previous history of other malignancy; 2. presence of uncontrolled active infection; 3. evidence of disorder that need the treatment by glucocorticoids; 4. active or chronic gvhd 5. the patients treatment by inhibitor of t cell 6. pregnant or breasting-feeding women; 7. any situation that investigators regard not suitable for attending in this study (e.g. hiv , hcvinfection or intravenous drug addiction) or may affect the data analysis.

Keywords: multiple myeloma bcma prime chimeric antigen receptor t cell
the importance of insulin action in the brain for the immune system during physical activity

Conditions: Insulin Sensitivity

Summary: the goal of this clinical trial is to clarify the interaction of central insulin action and physical activity with the immune system. therefore, participants will undergo bicycle spiroergometer tests. this approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

this research project aims to investigate if the brain insulin action regulates the immune system via the autonomous nervous system during physical activity. therefore, insulin action in the brain will be introduced by application of insulin as nasal spray (on one day) versus carrier solution as placebo nasal spray (on another day) in a randomized, blinded fashion. spray administration will be performed 30 minutes before a 60 min bicycle spiroergometer test at 70 % vo2max that will introduce a postprandial state. on placebo day, the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate i.v. insulin bolus. using this approach, brain-derived regulation of the immune system including the stimulation of immune cells via cytokines, physical performance, activity of the autonomous nervous system and gene-expression of leukocytes will be examined.

Eligibility criteria:
inclusion criteria: * bmi \< 24 kg/m2 * no known primary diseases * hormonal contraception with a single-phase preparation exclusion criteria: * alcohol or drug abuse * smoking * at screening: hb \< 12 g/dl for women and hb \< 14 g/dl for men * any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.

Keywords: brain insulin action autonomic nervous system physical activity
efficacy of pantoprazole in patients older than 12 years who have symptoms of non-erosive reflux disease (nerd) or erosive gastroesophageal reflux disease (egerd)

Conditions: Gastroesophageal Reflux Disease

Summary: the aim of the study was to evaluate the effect of 7 days treatment with pantoprazole 40 mg and 20 mg on symptoms in patients with nerd (non-erosive reflux disease) or egerd (erosive gastroesophageal reflux disease) in clinical practice. during the study, the patients had to complete a short version of a patient-orientated, self-assessed reflux questionnaire (request™ in practice).


Eligibility criteria:
main inclusion criteria: * outpatients with erosive gastro-esophageal reflux disease (egerd according to los angeles classification grade a-d) or non-erosive reflux disease (nerd) main exclusion criteria: * criteria as defined in the summary of product characteristics (chapter 4.3)

Keywords: ppi (proton pump inhibitor) therapy pantoprazole egerd (erosive gastroesophageal reflux disease) nerd (non-erosive reflux disease)
long term arrhythmia risk and cardiovascular events in hematopoietic stem cell transplant

Conditions: Hematopoietic Stem Cell Transplant; Atrial Fibrillation; Atrial Flutter

Summary: the purpose of this study is to better understand the following aims: 1. aim 1: to evaluate the rate of recurrent atrial fibrillation (af)/atrial flutter (afl) in hematopoietic stem call transplant (hcst) patients with incident af/afl identified during the initial 30 days of the transplant 2. aim 2: to evaluate incident episodes of 1) stroke/tia; 2) other thromboembolic events (not stroke/tia); 3) heart failure events; 4) ischemic heart events 3. aim 3: to evaluate overall implantation safety in this population

we propose a registry study in hematopoietic stem cell transplant (hsct) patients with incident atrial fibrillation/atrial flutter (af/afl) during the initial 30 days of transplant who will be implanted with the medtronic reveal linq implantable cardiac monitor (icm) within 90 days of hsct. we will evaluate the rate of recurrent af/afl as well as incident episodes of major cardiovascular events and the safety of icm implantation in this population.

Eligibility criteria:
inclusion criteria: 1. age ≥18 2. chads-vasc ≥ 2 3. recovery of platelets to \>50,000 within 90 days of incident atrial fibrillation (af) diagnosis 4. discharge from the incident stem cell transplant (sct) hospitalization 5. normal sinus rhythm at the time of consent exclusion criteria: 1. prior history of atrial fibrillation (af) or atrial flutter 2. chads-vasc \<2 3. platelets \<50,000 after 90 days post transplantation 4. continued sct hospitalization at 90 days 5. inability to receive anticoagulation 6. af or other arrhythmia at the time of consent 7. current use of a class ic or iii antiarrhythmic medication 8. inability to provide informed consent/significant cognitive impairment 9. expected survival less than one year.

Keywords: atrial fibrillation hematopoietic stem cell transplant atrial flutter
the immunological profile of nickel dermatitis

Conditions: Nickel; Eczema; Nickel Sensitivity; Allergy; Inflammatory Response

Summary: a dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.

clinically controlled study comprising 15 people with known nickel allergy and 15 healthy persons as control group. at the department of allergy and dermatology, gentofte hospital, test participants will be exposed to nickel sulfate in a patch test on their back, which will create an eczema reaction in people with nickel allergy and induce skin resident t-cells. the resident t-cells will enhance further exposure. the eczema is healed over 3-4 weeks, after which the same areas are again exposed to nickel sulfate at different concentrations in a patch test. skin biopsies of the exposed areas are taken and the immune phenotype is analyzed trough nanostring rna technologies of around 600 immunerelated genes.

Eligibility criteria:
inclusion criteria * must be able to understand the written and oral participant information in danish. * previously proven nick allergy by patch testing within the last 5 years, for the nickel allergic test participants. exclusion criteria * pregnancy and / or breastfeeding. * systemic immunomodulatory treatments within the last 14 days. * local treatments of selected skin areas, such as applying hormone cream within the last two weeks or applying cream / lotion within 24 hours up to sample collection. * allergy to local anesthesia. * exposed to solar or sunlight on the back within 21 days. * history of inflammatory skin diseases, asthma, diabetes mellitus, hives or arthritis (exclusion criteria only for participation in the healthy control group). * participation in another scientific experiment within the last 4 weeks. risks,

Keywords: patch test metal allergy
phase ii study of dcvac/pca after primary radiotherapy for patients with high risk localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether dcvac/pca added after radical primary prostatectomy can improve psa progression times within 5 years for patients with high risk localized prostate cancer.

treatment post radical primary prostatectomy treatment post standard radiotherapy

Eligibility criteria:
inclusion criteria: * male 18 years and older * histologically confirmed localized prostate cancer of high risk or very high risk fulfilling at least one of the following: t3-t4 stage or gleason score 8-10 or psa level above 20 ng/ml * indication for prostate cancer radical radiotherapy * neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using luteinizing-hormone-releasing hormone (lhrh) analogues ongoing for at least two months and not longer than 12 months prior randomization * eastern cooperative oncology group (ecog) 0-2 exclusion criteria: * primary surgical treatment of prostate cancer * prior or ongoing chemotherapy for prostate cancer * participation in other clinical study or administration of other evaluated drug within 30 day prior screening * unresolved lasting obstruction of urinary system * other uncontrolled inter-current illness * treatment with immunotherapy against prostate cancer * clinically significant cardiovascular disease * history of primary immunodeficiency * active autoimmune disease requiring treatment

Keywords: immunotherapy prostate cancer biological, vaccine
diagnostic and prognostic value of miss-1 study in children and adult with nephrotic syndrome missnephrotique

Conditions: Nephrotic Syndrome

Summary: the nephrotic syndrome is a rare disease defined by a proteinuria \>3g/24h and a hypoalbuminemia \< 30g/l. genetic and immune are the main causes. the acquired idiopathic nephrotic syndrome presents histologically minimal glomerular lesions, sometimes associated with segmental and focal hyalinosis. the idiopathic nephrotic syndrome (ins) represents 85% of children's glomerular nephropathy and 25-30% of adult's. relapses are frequents, and can be pejorative up to 10% and lead to end-stage kidney failure. another immune cause is the extramembranous glomerulonephritis mediated by molecular targets specific autoantibodies expressed at the podocytes surface. other immune causes include lupus nephropathy, anca vascularitis, goodpasture disease, berger disease. easy diagnosis between these causes can be made with the renal biopsy. miss-1, a new protein activated during a inflammatory event, could be an actor in nephrotic syndromes by modifying the podocyte's adhesion on the glomerular basal membrane. this would modulate the structure and function of the slit diaphragm, as well as junctions between the podocyte and the glomerular basal membrane, regulating podocytes' apoptosis.

this project is meant to propose and validate specific and non-invasive diagnostic and prognostic tests for the acquired idiopathic nephrotic syndrome. these tests rely on the measure of miss-1 expression in circulating blood cells on flow cytometry and its plasmatic concentration. to date, no equivalent tests exist to diagnose idiopathic nephrotic syndrome (ins) from other causes. these simple tests would allow a quick diagnosis of acquired ins by avoiding an invasive renal biopsy. it would also help anticipate the relapses of the disease and guide the treatment modalities as do nowadays the pla2r antibodies in idiopathic membranous nephropathy. we will propose the tests to every consent patient, hospitalized in the participating centers (néphrologie pédiatrique of robert debré hospital, néphrologie adulte of tenon hospital) with a nephrotic syndrome.

Eligibility criteria:
inclusion criteria: * all new hospitalized patient * presenting a nephrotic syndrome according to its definition * for which an anatomopathological diagnostic and its evolution can be or will be carried * children of any age can be included if they present a nephrotic syndrome exclusion criteria: - patients already treated with glucocorticoids and/or immunosuppressor

Keywords: idiopathic nephrotic syndrome minimal change diseases primitive fsgs