Kornimate/medical-research-clean huggingface dataset:
study of the prevalence of iron deficiency in patients with chronic inflammatory bowel disease

Conditions: Intestinal Disease

Summary: despite its known prevalence in ibd, a recent study conducted with prof. cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity. in chronic diseases including ibd, transferrin saturation factor is only performed in approximately 10% of cases, whereas it is recommended in inflammatory situations including ibd patients (has 2011). the objective of this study is therefore to obtain updated french data on the prevalence of iron deficiency in patients with ibd by applying the recommendations of ecco and french health high authority (determination of ferritinemia and transferrin saturation factor)


Eligibility criteria:
inclusion criteria: * patient, male or female, over 18 years old * patient present at the hospital on the day of the study * diagnosis of ibd on international criteria * patient giving written consent exclusion criteria: * protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; * pregnant, lactating or parturient woman; * patient hospitalized without consent
effect of alprazolam on the success of inferior alveolar nerve (ian) block

Conditions: Inferior Alveolar Nerve Block Failure

Summary: the purpose of this prospective, randomized, double-blind, placebo-controlled study is to evaluate the effect of preoperative administration of alprazolam on the success of the ian block for teeth with irreversible pulpitis.

sixty patients diagnosed with irreversible pulpitis of a mandibular molar randomly receive, in a double-blind manner, identical capsules of either 0.50 mg alprazolam or placebo 45 minutes before the administration of a conventional ian block. access is begun 15 minutes after completion of the ian block, and all patients profound lip numbness. success is defined as no or mild pain based on visual analog scale recordings during access preparation and initial instrumentation.

Eligibility criteria:
inclusion criteria: * patients with active pain in a mandibular molar * prolonged response to cold testing with endo-frost cold spray * absence of any periapical radiolucency on radiographs * a vital pulp while access cavity preparation * ability to understand the use of pain scales. exclusion criteria: * patients were having allergy and sensitivity to benzodiazepines * pregnant and breast feeding patients * patients who had taken sedation within 24 hours before the treatment * having pain in more than one mandibular tooth * unable to give informed consent

Keywords: alprazolam benzodiazepines inferior alveolar nerve block irreversible pulpitis local anesthesia
manipulation of the gut microbiome by a standardized preoperative diet to prevent colorectal cancer recurrence and metastasis following surgery

Conditions: Colorectal Cancer

Summary: a single arm, prospective, single center phase1/2 dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. subjects will be provided 21 days of standardized high-fiber/low-fat meals and complete a food diary up until lunch on the day prior to surgery. blood samples will be collected at baseline and on the day of surgery. stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. tissue from the tumor resection will be isolated for organoid cultures. subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. subject may be treated for their cancer prior to surgery and/or during the follow-up period.


Eligibility criteria:
inclusion criteria: * must have histologically or cytologically confirmed colorectal adenocarcinoma. * planned for primary tumor resection at the university of chicago medicine ≥21 from date of obtained informed consent. patients with metastatic disease but undergoing primary site resection are eligible for the study. * age ≥18 years. * patients \<18 years of age, children are excluded from this study, because they have unique nutritional requirements that might not be met by with the standardized diet. the food in the diet is designed for adults and would not be feasible for children, especially those attending school. in addition, colon cancer is extremely rare in children. * may have received neoadjuvant therapy (chemotherapy, radiation). * patients with hepatic arterial infusion (hai) pumps are considered eligible. * ability to understand and willing to sign an informed consent, participate in the dietary intervention, collect stools, donate blood, and complete a pre-nutritional evaluation and compliance/patient satisfaction survey. exclusion criteria: * previous ostomy (ileostomy or colostomy) or definitive plan for an ostomy (ileostomy or colostomy) during the procedure. * antibiotic exposure within 60 days before diet initiation. antibiotic exposure is defined as a 'course of treatment to treat an infection'. prophylactic antibiotics prior to a procedure is okay. * prebiotic/probiotic exposure within 60 days before diet initiation. * concomitant separate malignancy. * allergy to perioperative medications (oral neomycin/metronidazole for bowel preparation, intraoperative prophylactic intravenous cefazolin and metronidazole). * patients who are pregnant are not eligible for the study. pregnant women are excluded from this study because the preoperative diet is not specifically formulated to meet the specific nutritional requirements during the prenatal period. * history of inflammatory bowel disease * severe food allergies precluding the ability to tolerate the standardized dietary intervention. * patients with uncontrolled intercurrent illness
a study of bevacizumab in combination with bortezomib in patients with relapsed or refractory multiple myeloma (amber)

Conditions: Multiple Myeloma

Summary: this is a randomized, blinded, placebo-controlled, multicenter, phase ii study designed to provide a preliminary assessment of the safety and efficacy of combining bevacizumab with bortezomib in patients with relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * previously diagnosed with multiple myeloma * relapsed or refractory multiple myeloma with disease progression following one to three prior treatment regimens * measurable multiple myeloma disease exclusion criteria: * grade ≥ 2 peripheral neuropathy * use of corticosteroids within 21 days prior to day 1 * use of other anti-myeloma therapy within 21 days prior to day 1 * intolerance to bortezomib or compounds containing boron * life expectancy of \< 12 weeks * current, recent, or planned participation in an experimental drug study * active malignancy other than multiple myeloma within 5 years before screening * prior treatment with bevacizumab * inadequately controlled hypertension * prior history of hypertensive crisis or hypertensive encephalopathy * new york heart association (nyha) class ii or greater congestive heart failure (chf) * decreased left ventricular function at study entry * history of myocardial infarction or unstable angina within 6 months prior to day 1 * history of stroke or transient ischemic attack within 6 months prior to day 1 * significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to day 1 * evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1, or anticipation of need for major surgical procedure during the course of the study * core biopsy or other minor surgical procedure, including placement of a vascular access device within 7 days prior to day 1 * history of abdominal fistula or gastrointestinal perforation within 6 months prior to day 1 * serious, non-healing wound, active ulcer, or untreated bone fracture (for pathologic bone fractures consistent with multiple myeloma, patients may be eligible if no treatment is planned) * albuminuria * known hypersensitivity to any component of bevacizumab * pregnancy (positive pregnancy test) or lactation

Keywords: avastin amber myeloma velcade
lfmt vs placebo in new biologic start for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: to compare the safety and efficacy of concomitant lfmt versus placebo in uc patients who are starting vedolizumab or ustekinumab.

this is dual-center, randomized, double-blind, placebo-controlled pilot trial for uc patients with active disease who are being initiated on treatment with vedolizumab or ustekinumab. the study will recruit 40 outpatients at 2 canadian healthcare centres at the university of alberta hospital (university of alberta), and the hamilton health sciences (mcmaster university).

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older but less than 75 years of age 2. able to provide informed consent 3. established ulcerative colitis diagnosis determined by a physician through standard endoscopic and histologic criteria 4. active uc defined as total mayo score between 6-12 and mayo endoscopic sub-score \>1 with disease that extends 15 cm or more from the anal verge 5. selected by treating physician for initiation of biologic treatment with either vedolizumab or ustekinumab. patients must be: * biologic naive; or * have failed anti-tnf, anti-integrin, anti il12/23 or oral small molecules 6. use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial 7. willing and able to comply with all required study procedures exclusion criteria: 1. severe uc requiring hospitalization 2. indeterminate colitis 3. evidence of or treatment for c difficile infection or other intestinal pathogen, including cmv, within 4 weeks prior to enrollment 4. evidence of toxic megacolon or gastrointestinal perforation on imaging 5. abdominal surgery within the past 60 days * neutropenia with absolute neutrophil count \<0.5 x 109/l * peripheral white blood cell count \> 35.0 x 109/l and fever (\>38 degrees celsius) * planned or actively taking another investigational product * uncontrolled medical conditions such as psychiatric disorders or substance abuse * severe underlying disease such that the patient is not expected to survive for at least 30 days 6. pregnant or lactating 7. unwilling to discontinue non-dietary probiotic 8. antibiotic use in the past 30 days or anticipated need for systemic antibiotic use during study 9. fmt within 3 months prior to enrollment 10. use of the following medications: 1. rectal/topical therapy within 2 weeks of screening 2. cyclosporine, tacrolimus or thalidomide within 4 weeks of screening 3. tofacitinib within 4 weeks of screening 4. adalimumab or infliximab within 8 weeks of screening 5. vedolizumab within 8 weeks of screening 6. ustekinumab within 12 weeks of screening 7. prednisone \> 30 mg/d 11. investigator deems enrolment in the study is not in the best interest of the patient

Keywords: fmt microbiome
open-label extension treatment with etanercept (tnfr:fc) for participating patients in etanercept (tnfr:fc) clinical trial 016.0012

Conditions: Rheumatoid Arthritis

Summary: this is an open label, multicenter study for extended treatment of patients who have participated in the immunex clinical study 016.0012. the primary objective of this study is to evaluate the long term safety of etanercept (tnfr:fc) in patients with early stage rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: - previous enrollment in immunex protocol 016.0012. * no clinically significant adverse events thought to be due to etanercept (tnfr:fc) during previous treatment. * negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. * no more than one nsaid at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (tnfr:fc). exclusion criteria: * previous receipt of etanercept (tnfr:fc) (p55), antibody to tnf, anti-cd4 antibody, or diphtheria il-2 fusion protein. * receipt of investigational drugs or biologics (other than etanercept (tnfr:fc)) within interval between study drug in 016.0012 and this study. * receipt of dmards (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, d-penicillamine, sulfasalazine, minocycline, or leflunomide) other than mtx within two weeks prior to the first dose of etanercept (tnfr:fc) in this study. * receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (tnfr:fc) in this study.

Keywords: rheumatoid arthritis etanercept long-term safety enbrel
study of an nk-1 anti-emetic medication for the prevention of post-operative nausea and vomiting in female patients

Conditions: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative

Summary: the purpose of this study is to determine the effectiveness of this medication in preventing nausea and vomiting in female patients at risk for post-operative nausea and vomiting (ponv).

a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, phase ii study to evaluate the safety, efficacy, and pharmacokinetics of oral (25 mg) and intravenous (3 mg and 18 mg) formulations of the neurokinin-1 receptor antagonist, gw597599, when administered with intravenous ondansetron hydrochloride for the prevention of post-operative nausea and vomiting and post-discharge nausea and vomiting in female subjects with known risk factors for ponv who are undergoing surgical procedures associated with an increased emetogenic risk

Eligibility criteria:
inclusion criteria: * known risk factors for ponv. * undergoing gynecological or gallbladder surgery.

Keywords: post-operative nausea and vomiting ponv
comparison of interscalene and pericapsular nerve group (peng) block in shoulder surgery

Conditions: Visual Analogue Score

Summary: early postoperative pain after shoulder surgery is a major concern and distress for patients and orthopedic surgeons. adequate pain control; it is vital for all aspects of patient recovery, including mental state, nutrition, cost of care period, rehabilitation, patient satisfaction, and overall post-surgery outcomes.single analgesic regimens are not always effective in controlling moderate to severe postoperative pain.therefore, multimodal pain management is preferred and is currently recommended for early postoperative pain control.regional anesthesia is preferred in shoulder surgery as an effective way to provide anesthesia and postoperative analgesia.to ensure adequate postoperative pain control, nerve supply to the synovium, capsule, joint surfaces, ligaments, periosteum and shoulder muscles must be blocked.interscalene blocks are well studied and established means of providing analgesia following shoulder surgery and are considered the gold standard mode of regional anesthesia.pericapsular nerve group block is a new block that provides a pericapsular distribution with local anesthetic infiltration around the glenohumeral joint and provides analgesia without motor blockage by reaching the sensory nerve branches of the glenohumeral joint.the aim of this study was to compare the results between interscalene block and pericapsular nerve group block in patients undergoing shoulder surgery.


Eligibility criteria:
inclusion criteria: * 18 years and over * american society of anesthesiologists (asa) 1 and 2 * shoulder surgery exclusion criteria: * under 18 years old * american society of anesthesiologists (asa) 3 and above * who are allergic to local anesthetics * patients with infection at the injection site * pregnant women
the place of consultations specializing in the diagnosis of mood disorders in strasbourg university hospital

Conditions: Mood Disorders

Summary: mood disorders (depressive disorders and bipolar disorders) are among the ten most worrying diseases of the 21st century according to the who. in order to support psychiatrists in their diagnostic reflection, structures have been created. since 2009, the psychiatry service 2 within the psychiatry, mental health and addictology pole of the university hospitals of strasbourg has offered specialized consultations in mood disorders. more than 10 years after the creation of these consultations, it seems interesting to study the profile of the users and to describe the nature of the reports of these in-depth evaluation consultations (diagnosis, therapeutic advice)


Eligibility criteria:
inclusion criteria: * major subject * specialized primary consultation highlighting symptoms of mood disorders with prof. berstchy in the psychiatry department 2 in the university hospital of strasbourg (patients whose consultation request was linked to symptoms or a diagnosis of adhd will not be included in the study population). * consultation that took place in 2018 and 2019. * patient who did not express his opposition to the reuse of his data for scientific research purposes. exclusion criteria: * patient opposition to the use of their personal data for scientific research purposes. * prior existence of a previous specialist consultation in mood disorders with prof. berstchy (the information collected during the first consultation is not accessible) * patient under curatorship, guardianship or legal protection

Keywords: mood disorders
depression medication choice decision aid

Conditions: Depression

Summary: the quality of care for patients facing depression, one of the most prevalent chronic diseases, needs improvement. despite its high incidence, depression remains sub-optimally managed, particularly in primary care, where most patients suffering from depression receive care. successfully treated depressive patients can potentially improve their burden of disease and significantly improve their quality of life, but not without the best treatment adapted to their contexts, preferences, and expectations. clinical research provides essential knowledge for the delivery of quality care which is unfortunately seldom applied in daily practice. one of the preferred methods for overcoming this lack of quality of care is shared decision making: a collaborative process between a clinician and patient that relies on the consideration of scientific evidence, in addition to the values and preferences of the patient. the use of decision aids supports this process by presenting scientific information in an accessible manner while focusing on patient-centered discussion. we developed and rigorously evaluated, in the united states, a decision aid regarding pharmaceutical treatment options for depression, depression medication choice, to be used by health professionals and patients during clinical encounters. the integration and impact of depression medication choice, in primary care practices in a canadian context is unknown. the specific objectives of this study are threefold: (i) evaluate the potential impact of the use of depression medication choice by health professionals and patients during clinical encounters on measures of the quality of the decisional process and on health issues important to the patient and health professional; (ii) document the processes and optimal measures to take to successfully realize projects on a larger scale; and (iii) evaluate the feasibility of performing patient-centered studies in a realistic context, minimally disturbing to the study environment, in the primary care context in quebec, canada. once completed, the estimated potential impact of this decision aid and shared decision making in primary care in a canadian context will have been measured, progressing toward high-quality patient-centered care. moreover, it will be possible to optimally perform future studies in realistic contexts while minimizing the burden on the clinics, their health professionals, and their patients.


Eligibility criteria:
inclusion criteria: * already have or receive a depression diagnosis (according to the treating clinician) * speak english of french * have no major obstacles providing clear written consent * discuss the possibility of taking antidepressants during the clinical encounter

Keywords: depression decision aid shared decision making primary care comparative effectiveness research
assessment of the usefulness of hemopatch in coronary artery bypass graft surgery

Conditions: CHD - Coronary Heart Disease

Summary: the study aim is to assess polyethylene glycol (peg) coated collagen patch (hemopatch) on the quality of drainage after surgery, the length of hospital stay, the number of reoperations due to haemorrhage and treatment cost. the study will be conducted in 200 patients undergoing coronary artery bypass grafting (cabg) with the use of extracorporeal circulation and internal mammary artery (ima) harvesting. traditional method of haemostasis will be applied in 100 patients and hemopatch will be additionally used in 100 subjects to prevent haemorrhage after ima harvesting and sternum closure.


Eligibility criteria:
inclusion criteria: * coronary heart disease chd (mammary harvesting) * age\>18 * informed consent exclusion criteria: * any condition that exclude patient from standard cabg procedure * additional cardiac procedure to be conducted on subject in addition to cabg
research into the quality of the dying phase

Conditions: Cessation of Life

Summary: the aim of this study is to get insight in the quality of life at the end of life and quality of dying for patients died at the hospital in the department groningen (the netherlands). the primary endpoint is the quality of life at the end of life and the secondary endpoint is the quality of dying. both according a numerical rating scale. an explorative analysis will be done for differences for the hospitals in groningen, effect of using the liverpool care pathway for the dying, effect of using consultation by the palliative consultation team, effect of using the hospice@umcg intervention, correlation with the quality of life at the end of life and quality of dying according to nurses and doctors.

three hospitals in the department groningen (the netherlands) will participate in this study. when a patient died in one of these hospitals (except the emergency department, child ward and intensive care unit) the bereaved relatives will get an information letter. after about 12 weeks a questionnaire will be sent to the bereaved relative. this questionnaire is developed to evaluate the end of life care at the hospital. shortly after the patient died at the hospital, also the nurse and doctor of this patient are requested to fill out a questionnaire. the questionnaire for the bereaved relatives consists of items, divided in groups: a general part, followed by questions of the last days of life, existing symptoms (physical, psychological, existential and social), the care and treatment and the loss. the questionnaire for the nurses exists of similar items. special attention for recognizing the impending dying and problems, care and therapy at the end of life. in all questionnaires there are also 2 main questions: what is your opinion of the quality of life during the last days of life and what is your opinion of the quality of dying. in the three hospitals the end of life care is managed at somehow different ways: the use of the liverpool care pathway of the dying, the hospice@umcg intervention and consultation by the palliative team of the hospital.

Eligibility criteria:
inclusion criteria: * patients dying in the hospital exclusion criteria: * patients dying at the child ward, emergency dept. and intensive care dept.

Keywords: palliative care quality of dying