Kornimate/medical-research-clean huggingface dataset:
a phase iiib study to evaluate the safety and efficacy of gemigliptin in type 2 diabetes mellitus patients with moderate or severe renal impairment(guard study)

Conditions: Type 2 DM Patients With Moderate or Severe Renal Impairment

Summary: therapuetic options are limited for type 2 diabetes mellitus (t2dm) pateints with renal impairment. this clinical study is to asses safety and efficacy of the dpp-4 inhibitor gemigliptin in patients with type 2 dm and moderate or severe renal impairment for long-term peirod (52 weeks).


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * patients with moderate or severe renal insufficiency * all patients give written informed consent exclusion criteria: * has type 1 diabetes mellitus or a history of ketoacidosis * is on dialysis or is likely to need dialysis during the study * has active liver disease

Keywords: renal impairment
cryoablation as a minimally invasive alternative to surgery for managing ductal carcinoma in situ

Conditions: Ductal Carcinoma in Situ

Summary: cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. the investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of dcis by examining its ability to achieve complete ablation of dcis within the targeted cryoablation zone of necrosis.


Eligibility criteria:
inclusion criteria: * dcis spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced mri * diagnosis of dcis by minimally invasive needle biopsy * no prior history of dcis or invasive breast cancer in the same breast * no history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast * adequate breast volume and skin clearance to permit cryoablation as assessed by dr. holmes. this excludes male and females with breasts too small to allow safe cryoablation * non-pregnant, non-lactating, and no history of pregnancy within the preceding 6 months * no history of breast radiation in the same breast

Keywords: dcis
oral ponesimod versus teriflunomide in relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: international clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis


Eligibility criteria:
inclusion criteria: male and female subjects aged 18 to 55 years with established diagnosis of ms mcdonald 2010 with relapsing course from onset (i.e., rrms and spms with superimposed relapses). subjects must have active disease evidenced by one or more ms attacks with onset within the period of 12 to 1 months prior to randomization, or by two or more ms attacks with onset within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing (gd+) lesion(s) of the brain on an mri performed within 6 months prior to randomization. enrolled subjects must be ambulatory (edss score of up to 5.5 inclusive) and may be treatment-naïve or previously treated with ms disease modifying therapy. exclusion criteria: subjects with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating or pregnant women are not eligible to enter the study. subjects with contraindications to mri or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study are not eligible to enter the study.

Keywords: relapsing multiple sclerosis
financial incentives to improve asthma

Conditions: Asthma in Children; Medication Adherence

Summary: the aim of this pilot randomised controlled trial is to assess the effectiveness of a short-term financial incentives intervention at bringing about behaviour change, namely short-medium term improvements in inhaled corticosteroid (ics) adherence and asthma control in children and young people (cyp) with asthma.

after obtaining informed consent from parents (and assent from the cyp), cyp will be enrolled in a 24-week programme. all participants will receive an electronic monitoring device (emd) which will be programmed with twice daily audio-visual reminders and will be required to download the emd-associated app onto their smartphones. all participants will be required to attend 3 study visits at 0 weeks (baseline), 12-weeks and 24-weeks (follow-up). at baseline participants will be assessed for inhaler technique and given an asthma action plan (if they do not have one already) and will be randomised to either the control group or the intervention group. intervention period will run between study visit 1 (0-weeks) and study visit 2 (12-weeks). over the intervention period, participants in the intervention group will use their emd with reminders, but will also be given financial incentives dependent upon their daily adherence and will have access to some additional emd-associated app features (including notifications, a reward totaliser and a traffic light calendar to monitor progress). control group participants will receive their usual care plus the use of emd with reminders over the intervention period. after the intervention period (at study visit 2), intervention participants will no longer receive rewards or be able to access the additional app features. all participants (control and intervention) will be able to use their emd with reminders for the final 12-week follow-up period. after completion of the 24-week programme, all participants will be required to return their emd devices and will be invited to a focus group to share experiences and feedback of the trial.

Eligibility criteria:
inclusion criteria: * informed consent obtained from parent/guardian and assent from child. * cyp with doctor diagnosed asthma presenting to emergency department (ed) with a severe asthma exacerbation (as defined by ers/ats guidelines). * aged between 11 and 17 years old * prescribed maintenance inhaled corticosteroids (ics) (which can include maintenance and reliever therapy mart) for at least 6-months. * own their own mobile smartphone (running android 8 or higher, or ios 13 or higher) * prescribed the following inhalers: clenil, flixotide, symbicort, seretide exclusion criteria: * parent/guardian / cyp unable to provide consent / assent * cyp with other, co-existing respiratory conditions * parent/guardian/cyp who are not fluent or able to understand the information provided in english. * cyp who are involved in other intervention research studies (including ctimps)

Keywords: electronic monitoring device financial incentives reminders asthma control
increasing colorectal cancer (crc) screening among hispanic primary care patients

Conditions: Colorectal Cancer

Summary: this study is designed to test a standard mailed intervention (si) versus a novel decision support and navigation intervention (dsni). working with patients and stakeholders, this randomized trial will include 400 hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for crc screening. we will consent, survey, and randomize participants either to the si group (n=200) or the dsni group (n=200). study specific aims are to: (1) assess intervention (dsni versus si) impact on overall crc screening adherence; (2)assess intervention (dnsi versus si) impact on crc screening decision stage; (3) assess intervention (dnsi versus si) impact on test-specific crc screening adherence; and (4) assess intervention (dnsi versus si) impact on crc and knowledge and perceptions.


Eligibility criteria:
inclusion criteria: * male or female * self-identifies as being hispanic or latino * 50 to 75 years of age exclusion criteria: * previous diagnosis of crc * up to date with crc screening guidelines. * personal history of inflammatory bowel disease * personal history of polyps * family history of crc diagnosed before the age of 60 years

Keywords: colorectal cancer cancer screening decision support navigation
axillary block in association with analgesic truncal blocks at the elbow for wrist surgery.

Conditions: Wrist Fracture

Summary: fractures of the forearm bones that occur around the wrist are common in the elderly. standard anesthesia for its surgical treatment is regional anesthesia (ra): supraclavicular block, infraclavicular block or axillary block (bax). however, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (la) is used. recently ra techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia. the hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting la combined with analgesic blocks at the elbow using a long-acting la could provide a ra installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.

this multicenter, prospective, randomized, open-label study compares two techniques : * bax (usual technique) : axillary brachial plexus block (axillary block) with a long-acting la (ropivacaine) * bax-asso (experimental technique) : axillary brachial plexus block (axillary block) with a short-acting local anesthetic (lidocaine) + analgesic block at the elbow with a long-acting local anesthetic (ropivacaine) every block will be performed under ultrasound. bax will be performed using a multi-injection technique at contact with median (nm), radial (nr), ulnar (nu), musculocutaneous (nmc) and medial antebrachial cutaneous (ncmab) nerves. 15-30 ml of la will be injected. analgesic truncal blocks of the median and radial nerves will be performed at the elbow. 3-7 ml of la will be injected.

Eligibility criteria:
inclusion criteria: * patients undergoing wrist fracture surgery under regional anesthesia * consent for participation * affiliation to the french social security system exclusion criteria: * chronic use of opiod analgesics * chronic pain syndrome or fibromyalgia * contraindication for locoregional anesthesia * contraindication for opioid * asa iv * pregnant or breastfeeding women * patients under protection of the adults (guardianship, curators or safeguard of justice) * communication difficulties or neuropsychiatric disorder

Keywords: regional anesthesia analgesia ultrasound
interactions between immune cells of intestinal mucosa or peripheral blood with the extracellular matrix in inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Disease

Summary: the purpose of this study is to examine the effects of different environmental factors on immune cells in patients with ibd.

background: inflammatory bowel diseases, comprised of crohn's disease (cd) and ulcerative colitis (uc) are idiopathic disorders caused due to immunological, genetic, and environmental factors. these disorders are fairly common (in the us, there are 11 cases of cd and 7 cases of uc for every 100,000 people). the frequency of ibd, especially cd, are constantly rising (1). clinical symptoms include diarrhea, rectal bleeding, abdominal pain, intestinal obstructions, and fistulas in cd. there are also systemic manifestations such as fever, weight loss, and anemia. the current hypothesis of ibd pathogenesis is an aberrant, ongoing, uncontrolled inflammatory response of the intestine, caused by commensal microbiota. the inflammatory response in ibd is mediated by t cells; in cd the pathologic lymphocytes are cd4 cells of th1 type, while uc is considered an atypical th2 response (2). cd4 t cells have a major role in initiation of inflammatory response in the gut, as well as a role in propagation and control of the inflammation. chemokines are low-molecular weight cytokines with chemoattractant capacity, and have a role in many inflammatory disorders. the chemokine cxcl12 is considered to be constitutively expressed (3). our group found increased expression of cxcl12 in ibd (ref?). this finding suggests that cxcl12 might have a role in inflammatory processes of the gut. understanding phenotypical and functional differences of lymphocytes in mucosal homeostasis and ibd, elucidation of factors causing these differences, and recognition of causes for increased cxcl12 expression, will enable to increase knowledge of ibd; as well as lead to development of future therapeutic interventions in ibd. research goals: to examine the effects of different environmental factors (cytokines, chemokines, extracellular matrix moieties) on immune cells from peripheral or intestinal source (in homeostasis or ibd) in terms of phenotypical and functional parameters. methods: 15 ml peripheral blood will be obtained from all participants. t lymphocytes will be isolated for the different experiments. methods will include: migration towards chemokines using the transwell assay, proliferation will be assessed by either brdu or thymidine incorporation, cytokine secretion will be determined using elisa, phenotypical characterization will be done using flow cytometry and adhesion assays. ages: adults and children aged 10-80. research group: approximately 40 patients (adults and children) suffering from ibd will be enrolled. control group: approximately 100 controls will be enrolled in the research.

Eligibility criteria:
inclusion criteria: * ibd

Keywords: ibd
metformin with neoadjuvant chemoradiation to improve pathologic responses in rectal cancer

Conditions: Rectal Neoplasm Carcinoma in Situ Adenocarcinoma

Summary: this study is a phase ii, single arm, controlled, open label internal pilot.

this internal pilot will be the first prospective study to assess the feasibility and efficacy of adding metformin in non-diabetic rectal patients who undergo standard of care neoadjuvant chemoradiation therapy (crt). the translational aim of the study will inform on predictive factors (such as p53) and mechanism of action (hypoxia, proliferation). metformin has been used for decades in patients with type 2 diabetes and has an extremely safe toxicity profile. with current interest in the use of metformin as a cancer therapeutic in non-diabetics, this study is expected to provide proof-of principle data for a larger study.

Eligibility criteria:
inclusion criteria: 1. plan for care inclusive of: i. standard of care neoadjuvant chemoradiation ii. planned total mesorectal excision (tme) 2. histologically confirmed adenocarcinoma of the rectum 3. at least one of the following: i. t3 or t4 lesions ii. t2 lesions ≤ 1 mm to the mesorectal fascia iii. node positive rectal tumor 4. ecog performance status of 0 or 1 5. provide written informed consent 6. female participants of childbearing potential agree to use adequate methods of contraception from the start of metformin administration until the start of crt. contraception will not be required to be continued during or after crt as this treatment renders participants infertile. clinically acceptable methods of birth control for this study include intrauterine devices (iud), birth control pills, hormonal implants, injectable contraceptives, and using barrier methods such as condoms, vaginal diaphragm with spermicide, or sponge. exclusion criteria: 1. diagnosis of diabetes 2. current use of metformin 3. prior pelvic radiation 4. life expectancy \< 6 months. 5. active infection 6. creatinine \> 1.5x uln, within 1 month prior to baseline 7. ast, alt \> 2.5x uln, within 1 month prior to baseline 8. bilirubin \> 1.5 uln, within 1 month prior to baseline 9. pregnant or breastfeeding women

Keywords: rectal cancer adenocarcinoma of the rectum node positive rectal tumors metformin neoadjuvant chemoradiation
comparison the hemodynamics effects between dexmedetomidine and propofol in major abdominal surgical patients

Conditions: Abdominal Tumor; Intestinal Obstruction; Cirrhosis; Intestinal Fistula; Aneurism

Summary: the alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic qualities and lack of respiratory depression. patients sedated with dexmedetomidine could be easily roused, these advances shows dexmedetomidine may be a effective and safe sedative agent. but some studies showed some adversely effects of dexmedetomidine on haemodynamics (such as bradycardia, hypotension), the investigators want to further research the effects of dexmedetomidine on haemodynamics, such as cardiac output (co), systemic venous resistance index(svri), and so on. propofol is widely used sedative agent in icu, it also has adversely effects like bradycardia and hypotension, so the investigators want to compare the effect of dexmedetomidine with propofol on haemodynamics after major abdominal surgery. expect to further research the mechanism of haemodynamics of dexmedetomidine.

when the patients can be roused, they will first receive analgesia with bolus of fentanyl 0.03mg, followed by a continuous infusion at a ﬁxed dose of 0.3μg/kg/h during study period. then patients will be randomly divided into two groups (dexmedetomidine and propofol). all of them will receive hemodynamic monitoring through "vigileo"(edwards lifesciences) and cardiogram monitor. the study will continue for 6-24 hours.

Eligibility criteria:
inclusion criteria: 1. postoperative patients of major abdominal surgery 2. age ≧ 18 exclusion criteria: 1. heart rate ≤ 50 bpm 2. allergy with dexmedetomidine or propofol 3. pregnancy
iv acetaminophen after cardiac surgery - pilot

Conditions: Delirium

Summary: double blind double dummy of intravenous acetaminophen and oral acetaminophen placebo versus iv placebo versus oral acetaminophen in patients following cardiac surgery. the primary endpoint is development of delirium during the post-operative stay.

the study is randomized, double-blinded, and multicentre. enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. the intervention is blinded iv acetaminophen and blinded oral active or placebo acetaminophen . the study will start with a pilot trial of 120 patients at 4 centers- 30 at each site, 15 per group. the pilot is a vanguard. if the pilot shows appropriate compliance with the protocol, reliable blinding and appropriate enrolment, the results will not be unblinded but rolled into the full study. stratification will be by site and age \ = 60.

Eligibility criteria:
inclusion criteria: * subjects \> 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery exclusion criteria: * • refusal by surgeon for inclusion of the patient * requested late extubation by anesthesia or surgeon * intra-aortic balloon pump * sensitivity to acetaminophen * pre-operative cognitive dysfunction * psychiatric history with active treatment * parkinson's disease * alzheimer's disease * medication for cognitive decline * history of recent seizures * recent history of alcohol misuse * creatinine clearance less than 30 ml/min
chronic anterior shoulder instability in the military

Conditions: Shoulder Dislocation

Summary: anterior shoulder instability is a chronic condition that occurs after an anteromedial dislocation. its prevalence is high in athletes but has been little studied in the armed forces. in general, patients with a first episode of dislocation have a 1 in 2 chance of experiencing at least one recurrence. the more recurrences there are, the more damage there is to the joint and the greater the disability for the patient. the decree determining the medical aptitude of military personnel emphasizes the need to have recourse to a specialized consultation to determine the classification of the soldier after a first episode of dislocation. in the absence of data collected specifically in the military population, classification is based on the surgeon's experience and extrapolation of results obtained in the general population.


Eligibility criteria:
inclusion criteria: * military member with a first episode of true anterior glenohumeral shoulder dislocation, * male or female, * major, * having a sufficient level of reading/writing of the french language, * did not object to participating in the study. exclusion criteria: * patient with a history of homolateral shoulder dislocation or surgery on the affected shoulder, * collagen disease confirmed by genetic testing, * inflammatory arthropathy, * history of rotator cuff injury, * insufficient french reading/writing skills, * under legal protection, * objection to participating in the study.
tranexamic acid study

Conditions: Arthroplasty, Replacement, Hip

Summary: the purpose of this study is to determine if tranexamic acid significantly reduces blood loss and blood transfusion in revision total hip replacement. tranexamic acid is a drug that helps to reduce blood loss during surgery. revision total hip replacement surgery is treatment for patients who have previously had hipe replacement surgery which failed and must be repaired/replaced.

tranexamic acid is an anti-fibrinolytic agent that inhibits fibrinolysis leading to a reduction of blood loss without concurrently increasing the risk of thromboembolic complications. several studies have shown that tranexamic acid reduces blood loss and blood transfusions in primary total hip and knee arthroplasty. however, there have not been any studies that evaluate its efficacy in revision total hip arthroplasty. the significance of this study is that the need for blood transfusions and their complications may be minimized in revision hip arthroplasty if tranexamic acid is found to significantly decrease the amount of blood transfusions. after the patient has been consented, he or she will be randomized into one of two groups (tranexamic acid and placebo) by the school of pharmacy. the placebo will be crystalloid fluid of equal volume as tranexamic acid. the patient will then undergo revision total hip arthroplasty by dr. rosenstein and be administered tranexamic acid or placebo. blood loss will be recorded intraoperatively and postoperatively through drains. criteria for blood transfusion include hemoglobin less than 10g/dl or hematocrit less than 30%. once the operation ends, the drug or placebo will be discontinued and the postoperative care is unchanged from current standards/protocols. intraoperative blood loss, total blood loss, and number of blood transfusions will be recorded and analyzed. length of acute hospital stay will also be recorded. a cost analysis will be performed comparing tranexamic acid to blood transfusions.

Eligibility criteria:
inclusion criteria: * failed primary total hip arthroplasty (femoral stem, acetabular component, or both) * 18-100 years of age exclusion criteria: * prosthetic infection * primary total hip arthroplasty * prisoners * pregnancy * previous adverse reaction to tranexamic acid * bleeding/coagulation disorders * renal insufficiency (serum creatinine\>two standard deviations for age) * history of deep venous thrombosis or pulmonary embolism * religious beliefs/practices prohibiting blood transfusions * wards of the state * cognitively impaired patients * terminally ill patients * students and/or employees * color blindness

Keywords: tranexamic acid revision total hip replacement reduction in blood loss