Kornimate/medical-research-clean huggingface dataset:
methotrexate-associated anti-tnf combination therapy, the neglected one !

Conditions: Chronic Inflammatory Bowel Disease

Summary: the results of the sonic trial represented a significant advance in the management of patients with chronic inflammatory bowel disease by demonstrating the superiority of the combination of an alpha tnf anti-tnf with immunosuppressive therapy in naive patients (infliximab and azathioprine) compared to monotherapy in terms of clinical and endoscopic remission (40% versus 22%, p = 0.017). the benefit of this combination therapy is both pharmacological (addition, or even synergy of the two treatments) and immunological (reduction of the risk of immunization to biotherapy). data on the use of immunosuppressive methotrexate treatment are divergent. indeed, a previous randomized trial suggested that the combination of anti-tnf alpha including infliximab and methotrexate was no more effective than anti-tnf alpha monotherapy in patients with crohn's disease. however, the superiority of this combination has been clearly demonstrated over monotherapy in rheumatology for a long time. in practice, more and more practitioners are prescribing this combination (antitnf and mtx) in ibd patients because of tolerance problems, particularly to azathioprine or in patients with a dual expression of their disease, both digestive and joint. the interest of my thesis work is therefore to be able to clarify these grey areas and to be able to modify or comfort therapeutic choices in practice.

data will be extracted from medical records (age, gender, smoking status, date of diagnosis of chronic inflammatory disease, date of first prescription of antitnf alpha either infliximab or adalimumab, date of start and end of immunosuppressive azathioprine/6mp and/or metrotrexate, mode of administration of per os or sc/iv treatment, efficacy based on validated clinical scores hbi-pdai-mayo, tolerance). a collection will be made on the university hospital from a computer workstation. an analysis will then be carried out to write the publication secondarily. the data retention period will be one year from november 2019 to november 2020 depending on the duration of this thesis work, which is estimated at one year. expected results and prospects : " methotrexate-associated antitnf alpha combination therapy is as effective and safe as traditional azathioprine combination therapy in patients with ibd. the positive results may in practice lead to changes in our practices and give first priority to this combination therapy with methotrexate. "

Eligibility criteria:
inclusion criteria : - patients with chronic inflammatory bowel disease including crohn's disease and ulcerated rectocolitis under combination therapy with anti-tnf alpha exclusion criteria: subject unable to read

Keywords: crohn's disease ulcerated ulcerative colitis
elucidating the role of microvascular dysfunction in heart disease in women

Conditions: Microvascular Dysfunction

Summary: the purpose of this study is to determine if women with chest pain and "clean" heart blood vessels have impaired blood flow to the heart due to problems with the small blood vessels that provide blood and oxygen to the heart. impairment in the small blood vessels will be tested using ultrasound pictures of the heart, called myocardial contrast echocardiography. since these small blood vessels are not seen in a coronary angiogram, which is an x-ray of the heart vessels using a dye containing iodine injected in the heart vessels, the problem may remain undiagnosed in women until the heart muscle becomes severely damaged. a second purpose is to identify if there is a common trait in the population of women with this tiny blood vessel dysfunction, which will be investigated by checking blood levels of certain chemical and hormones related to heart disease. finally, we would like to investigate the relationship between depression and stress, and heart disease. we will do this by measuring cortisol (a hormone that serves as a measure of stress) and administering questionnaires that help to identify depression and stress.


Eligibility criteria:
inclusion criteria: * women 45 to 75 years of age exclusion criteria: * pregnancy * allergy to any component of the drugs: definity®. dipyridamole aminophyllin or iodine. * known coronary heart disease, significant valvular disease (valvular stenosis or insufficiency greater than moderate) left ventricular systolic dysfunction, congenital heart disease or cardiac shunt, pulmonary hypertension, moderate or severe asthma. * inability to reach the patient by mail, fax, e-mail or phone * active infection * malignancy * uncontrolled hypertension * smoking * severe asthma * kidney disease

Keywords: cardiac disease vascular dysfunction women chest pain echocardiography
mesenchymal stem cell transplantation in the treatment of chronic allograft nephropathy

Conditions: Kidney Transplant; Chronic Allograft Nephropathy

Summary: mesenchymal stem cell (msc) have been shown to have immunosuppressive and repairing properties. the investigators will infuse expanded msc into patients who develop chronic allograft nephropathy. the purpose of this study is to find out msc is more effective in preventing organ rejection and maintaining kidney function.

kidney transplantation is a common procedure in hospitals, but organ rejection and chronic nephrotoxicity are potential problems for the patient. approximately ninety percent of the protocol biopsies of renal allografts, performed at 18 months post transplantation, show histological lesions of chronic calcineurin nephrotoxicity. mesenchymal stem cell (msc) has been shown to have immunosuppressive and repairing properties. some patient in this study will also receive two infusions of expanded msc. this study will evaluate the safety and effectiveness of msc infusions in patients . this study will last 2 years. participants will be randomly assigned to receive either the full immunosuppressive therapy and msc infusions (group 1) or immunosuppressive therapy alone (group 2). patients will undergo msc infusions at the start of the study on day 0. one year post- infusions, patients will be evaluated. at months 12 participants will undergo kidney biopsies. blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. the transplanted kidney function will be evaluated.

Eligibility criteria:
inclusion criteria: * recipients of a renal allograft, male and female patients age 18 to 60 years of age. * ability to provide written informed consent. * the serum creatinine form 176umol/l(2mg/ml) to 440umol/l(5mg/ml) * renal biopsy criteria: chronic allograft nephropathy (banff i-ii). * immunosuppressant:cni and mmf and sirolimus * written informed consent, compliant with local regulations. exclusion criteria: * recipients with leucopenia (wbc \ 300 mg/dl or triglycerides \> 300 mg/dl). * recipients of multiple organs. * pregnant women. * previous history of malignancy * active infection including hepatitis b, hepatitis c, hiv, or tb as determined by a positive skin test or clinical presentation, or under treatment for suspected tb. * evidence of cardiovascular disease, existing congestive cardiac failure on physical exam and/or acute coronary syndrome in past 6 months. * inadequate compliance to treatment.

Keywords: kidney transplant chronic allograft nephropathy mesenchymal stem cell infusion
rct: multi-modal analgesia for laparoscopic cholecystectomy

Conditions: Gallstones; Cholelithiasis; Pain

Summary: analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. topical cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after laparoscopic cholecystectomy.

background: peri-portal nerve stimulation has recently been suggested as a mechanism for pain after laparoscopic cholecystectomy (lapchole). we therefore conducted a prct to evaluate whether somatovisceral pain blockade reduces pain after lapchole. hypothesis:analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective lapchole for symptomatic cholelithiasis. specifically, topical cystic plate and port-site infiltrationwith0.25% bupivacaine significantly reduces pain after lapchole. design: single-blinded prct setting: academic medical centers patients and methods: between february and may 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to institutional standard non-opioid/opioid analgesic combinations (n=32), and institutional standard analgesia plus topical 0.25%bupivacaine spray onto the cystic plate and local 0.25% bupivacaine port-site injection,post-lapchole (n=31). primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 1 week post-lapcholeusing the visual acuity score (vas, 0-10). results: study groups were comparable clinicopathologically. there were no study-procedure-associated adverse events. a statistically significant reduction in mean pain score was apparent in patients receiving multi-modal analgesia at all early (1-6 hours) post-operative time points and at one week following lapchole(p\<0.05). conclusion: this prct shows significantly improved pain reduction with somatovisceral pain blockade than institutional standard analgesic combinations following lapchole for symptomatic cholelithiasis. for centers not utilizing adjunctive local anesthetic for this operation, this multi-modal analgesic approach can improve patient comfort during recovery.this approach serves as the basis for a planned 4-arm prct designed to provide further insights into the role of local anesthetics in multi-modal operative site analgesia.

Eligibility criteria:
inclusion criteria: * symptomatic cholelithiasis undergo elective laparoscopic cholecystectomy * non - pregnant women * 18 years or older exclusion criteria: * undergoing urgent cholecystectomy * patients operated on for indications other than symptomatic cholelithiasist * those having conversion from laparoscopic to open cholecystectomy * those that withdrew from the study for any reason before the end of the required 7-day follow up (including those that died during that period) * those with incomplete data.

Keywords: gallstones cholelithiasis cholecystectomy, laparoscopic pain
anesthetists after the pandemic in the eyes of the public

Conditions: Anesthesia; COVID-19 Pandemic

Summary: anaesthesia and anesthesiologist from the very beginning has obtained "behind the screen" role. this is of great concern as the field of anesthesiology has expanded its services to various specialities like intensive care, postoperative pain management, labour analgesia, accident and trauma management, casualty etc. the role assigned to the anesthesiologist remains inaccurate even during covid 19 pandemic. the aim of this study was to evaluate general publics' perception about anesthesiologist\& anesthesia in operating and especially intensive care units during covid 19 pandemic.

method: a questionnaire consisting of 27 questions was asked to fill by the general population via the social media. the questionnaire consists of two parts: the first part includes demographic data such as age, gender, education level, occupation; the second part includes the questions about anesthesia experience and knowledge.

Eligibility criteria:
inclusion criteria: - subjects older than 16 years of age and not working in any health sector will be included in the study. exclusion criteria: * if she/he doesn't want to join
impact of protect your colon™ on crc screening

Conditions: Colorectal Cancer Screening

Summary: the purpose of the research is to assess the impact of protect your colon™, a colorectal cancer (crc) screening decision aid, on patients' crc screening behaviors. the investigators hypothesize that protect your colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase crc screening uptake. to test this hypothesis, the investigators will conduct a pilot randomized controlled trial (rct) to assess if provision of protect your colon™ improves communication on crc screening, intent to complete screening, and ultimately uptake of screening vs. usual care.


Eligibility criteria:
inclusion criteria: * individuals 45 to 75 years old * no prior crc screening or not up-to-date with crc screening * not at high risk for crc (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of crc) exclusion criteria: * does not speak english * does not have internet access * any records flagged "break the glass" or "research opt out."

Keywords: decision aid stool test colonoscopy ct scan
a trial of degarelix in patients with prostate cancer

Conditions: Prostate Cancer

Summary: a phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.


Eligibility criteria:
inclusion criteria: * 18 years or older. * has a histological confirmed prostate cancer gleason graded). * has a screening testosterone above 2.2 ng/ml. * rising prostate-specific antigen (psa). * has eastern cooperative oncology group (ecog) score of ≤ 2. * has a life expectancy of at least one year. exclusion criteria: * current or previous hormone therapy. * has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening. * has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * has a heart insufficiency. * has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years. * has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the investigator. * has received an investigational drug within the last 28 days before the screening visit or longer if considered to possibly influencing the outcome of the current trial. * is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
study of the innate immune response to the acute phase of human leptospirosis - immunolepto

Conditions: Leptospirosis

Summary: the research hypothesis is based on a suspected strong involvement of the immune system in the genesis of serious manifestations of the disease (hepatitis, renal failure, thrombocytopenia, intra-alveolar hemorrhage). the question asked is that of the state of the immune system (quantitative and qualitative: activation markers, production of cytokines) evaluated by the study of circulating innate immune cells (monocytes, neutrophils, dendritic cells, lymphocytes, platelets).


Eligibility criteria:
inclusion criteria: * age ≥ 4 years; * weight ≥ 11 kg; * with ongoing symptoms compatible with a clinical diagnosis of leptospirosis. * and having a diagnosis of leptospirosis confirmed according to standard care procedures: preferably by polymerase chain reaction (pcr) (blood or urine) or, failing that, serology indicating a recent infection (positive immunoglobulin m (igm) or microscopic agglutination test (mat) technique with titer \>1/400 for a pathogenic serogroup) * and affiliated to a social security scheme exclusion criteria: * refusal of participation by the patient or his entourage if the patient is physically unable to give his opinion (coma, resuscitation, etc.). * not affiliated with social security * immunosuppression that may interfere with the interpretation of the results: chemotherapy in progress, immunosuppressants in progress for organ transplantation or autoimmune disease * patient under legal protection (guardianship, curators)
effect of citrate dialysate on vascular calcification

Conditions: Vascular Calcification

Summary: the goal of this study is to determine whether hemodialysis with citrate slows the progression of vascular calcification. participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. vascular calcification will be measured on mammograms that will be performed at 6-month intervals and additional blood samples will be obtained at 6-month intervals.

vascular calcification is a significant problem in dialysis patients that leads to poor outcomes. currently there is no therapy that directly addresses this problem. some of the dialysis solutions (dialysates) currently in use contain citrate, a potent inhibitor of calcium precipitation. in particular, citrate can bind to nascent hydroxyapatite crystals and prevent their propagation. blood citrate levels are greater after dialysis with citrate dialysates than with non-citrate dialysates, which could slow vascular calcification. however, this has never been investigated. prior research has shown that arterial calcification can be easily detected and reliably measured on routine digital mammograms, with sufficient sensitivity to follow progression. mammography is more sensitive in detecting arterial calcification than other imaging and associated with far less radiation and cost. this will allow the researchers to detect differences between citrate and non-citrate dialysates in a safe and convenient way. participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. vascular calcification will be measured by mammography every 6 months. the endpoint will be the difference in the rate of progression of breast arterial calcification (bac) between dialysis with citrate and non-citrate dialysates.

Eligibility criteria:
inclusion criteria: * hemodialysis patients with bac on mammograms exclusion criteria: * current warfarin use * severe hyperparathyroidism (likely to undergo parathyroidectomy in the next 2 years) * difficulty controlling serum calcium (likely to require changes in dialysate calcium concentration in the next 2 years) * life expectancy \< 2 years * prisoners * inability to give consent

Keywords: hemodialysis breast arterial calcification
tmj nextgeneration(tm) feasibility study

Conditions: Bruxism

Summary: the study is an open-label, prospective, single-center, non-randomized feasibility study of the bruxoff(tm) device to identify emg activity associated with bruxism, and to assess the impact of the tmj nextgeneration(tm) device upon the occurrence of night-time bruxism events and incidence of migraines and headache in subjects diagnosed with sleep bruxism.

the study will be conducted at one study center in the u.s. subjects will be enrolled in the trial for a period of 8 weeks. the study will consist of a screening phase lasting up to 2 weeks and a follow up treatment period lasting 8 weeks. subjects will visit the dental clinic twice during the screening period, then five times during the treatment period.

Eligibility criteria:
inclusion criteria: 1. subjects at least 18 years of age; 2. subject has had a diagnosis of sleep bruxism; 3. subject has been medically screened and diagnosed by a physician as having headaches and/or migraines; 4. subject is willing to comply with the usage instructions for the bruxoff device; 5. is able to read and understand the icf and has voluntarily provided written informed consent. 6. subject is able to open their mouth at least 17 mm to be fitted for the tmj nextgenerationtm device; 7. male subjects are willing to have a clean shaven face on the nights that the bruxoff device will be used; 8. subject agrees that when using the bruxoff device to keep their cellular phone in another room. exclusion criteria: 1. subjects with any physical or behavioral disorder, which, in the opinion of the principal investigator, may interfere with the use of the device or compliance with the study protocol; 2. subject has any sleep disorder other than bruxism; 3. subjects who have had direct trauma to the jaw; 4. subjects who have had prior tmj or ear surgery; 5. subjects who have a narrow ear canal or impression of the ear canal, which is prolapsed due to an anatomical shift or failure of the ear canal wall structure, or a canal that does not allow for the ear canal second turn to be identified; 6. subjects with visible or congenital ear deformity as observed on targeted physical exam; 7. subjects whose ear canal anatomy does not allow for fit of the study device; 8. subjects who have a history of ear pain unrelated to tmj; 9. subjects who have a history of ear drainage in the past 6 months; 10. subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam; 11. subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or tmd for more than six months; 12. subject has a pacemaker.
doppler ultrasound renal arterial resistive indices as predictor of multiorgan failure in patients with acute hypoxic respiratory failure admitted to respiratory intensive care unit (cryptic shock index- ricu)

Conditions: Respiratory Failure; Multi Organ Failure

Summary: patients with de novo respiratory failure undergoing non invasive ventilation (niv) present failure rates of mechanical ventilation ranging from 4 to 50%. causes for niv treatment failure are various but the onset of septic shock and subsequent multi-organ failure (mof) seem play a critical role. recent data show that the 37% of patients admitted to intensive care unit for de novo respiratory failure without any other organ failure experience multiple organ failure within the first days from admission. early identification of hypoxic patients at major risk for mof seems critical. physiological studies have demonstrated that the underlying mechanisms for organ damage preceding mof are those involved in the oxygen consumption (vo2)/oxygen delivery (do2) mismatch. doppler ultrasound indices of renal arteria resistance are directly correlated tot he vo2/do2 mismatch. with this study we aim at investigating the correlation between doppler ultrasound indices of renal arteria resistance in patients with de novo respiratory failure admitted to icu and the onset of mof within the first 7 days form admission.


Eligibility criteria:
inclusion criteria: * patients with de novo respiratory failure admitted to the respiratory intensive care unit of the university hospital of modena exclusion criteria: * age lower than 18 or higher than 85 * presence of organ failure apart form lung failure at the time of admission in the respiratory intensive care unit * pregnancy * difficult or unreliable ultrasound window for renal arterial resistive index assessment