Kornimate/medical-research-clean huggingface dataset:
the effect of a low fodmap diet in irritable bowel syndrome patients

Conditions: Irritable Bowel Syndrome; FODMAP

Summary: tertiary care ibs patients will be recruited for a prospective low fodmap intervention study, hereby focusing on the reintroduction phase of the diet, where patients are blindly challenged with different fodmap groups administered as powder, to be added to the strict fodmap exclusion phase. during the screening phase of two weeks, baseline data regarding psychological, nutritional, microbial, and genetics will be collected. predictors of treatment response (a 50-point drop on the ibs-severity scoring system (ibs-sss) during the strict fodmap exclusion phase of 6 weeks) will be studied with linear mixed models.


Eligibility criteria:
inclusion criteria: * patients are eligible for the study if all of the following criteria are met: 1. patients with irritable bowel syndrome as per rome iv diagnostic criteria * symptom characteristics of ibs according to rome iv criteria 2. patients must provide witnessed written informed consent prior to any study procedures being performed 3. patients aged between 18 and 70 years inclusive 4. male or female patients exclusion criteria: * patients are excluded from the study if any of the following criteria are met: 1. patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study 2. patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years 3. patients presenting with predominant symptoms of functional dyspepsia (fd) and of gastro-oesophageal reflux disease (gerd) 4. patients who changed their diet over the last 3 months or have previously tried the low fodmap diet are excluded from the study. 5. females who are pregnant or lactating are excluded from the study.
phase iv clinical trial to investigate the effect on blood glucose of evogliptin in patients with type 2 diabetes(evergreen)

Conditions: Type2 Diabetes

Summary: a multi-center, randomized, double-blind, active-controlled, parallel group, phase iv clinical trial to investigate the effect on blood glucose of evogliptin after oral administration in patients with type 2 diabetes

1. evogliptin 5mg group: administration with evogliptin 5mg for 0-24 weeks. 2. liniagliptin 5mg group: administration with linagliptin 5mg for 0-12 weeks, and with evogliptin 5mg for 13-24 weeks

Eligibility criteria:
inclusion criteria: * subjects with 7.0%≤hba1c≤10.0% at screening * subjects untreated with oral hypoglycemic agents within 8 weeks prior to screening * subjects with 20kg/m2≤bmi≤40kg/m2 at screening exclusion criteria: * subjects with fasting plasma glucose≥270mg/dl at screening * patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus * subjects with history of myocardial infarction, cerebral infarction within 24 weeks prior to screening * subjects with alt and ast 3 times or higher than upper normal range
evaluation of the sickkids team obesity management program

Conditions: Obesity

Summary: in january 2010 a new interdisciplinary clinic (stomp) was created to provide care for children and adolescents with severe 'complex' obesity. as part of the program, a subset of adolescents undergo bariatric surgery. there is a paucity of literature evaluating outcomes of children and adolescents participating in a 'clinical' setting and even fewer reports of outcomes of severely obese pediatric patients. previously, the investigators evaluated clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an outpatient interdisciplinary program at sickkids (the comprehensive care clinic for children with central tumours) and found significant benefit to those attending, including reduction of weight gain (or weight loss), improved psychosocial functioning, and increased care satisfaction. stomp is a natural extension of this program, incorporating some core elements (e.g., interdisciplinary team, frequent visits, individualized care plans for medically-complex adolescents) and building on other aspects, such as increased psychosocial intervention; involvement of a "key worker" (nurse practitioner) to support families; provision of continuity of care with other health providers in all settings, community services and schools; a more diverse patient population; and group support sessions. evaluation of the outcomes of this clinic is needed to inform best practice for children and adolescents with severe complex obesity

the primary objective is to conduct an evaluation of the stomp clinic as a model of care with a specific focus on: (i) patient outcomes (anthropometric, metabolic, and psychosocial); and (ii) care coordination and care satisfaction. patient outcomes will be compared against baseline evaluation data over time, and to a control group of patients not enrolled in the program, but who expressed interest in the program and were unable to attend.

Eligibility criteria:
inclusion criteria: * all patients enrolled in the stomp program are eligible to participate in the study. * control participants must be between 12-18 years of age with a bmi \>95th percentile for age. exclusion criteria: - control participants cannot be enrolled in the stomp program.

Keywords: obesity management adolescents body mass index treatment outcomes program evaluation
621 real world study

Conditions: Senile Cataract

Summary: this study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.


Eligibility criteria:
inclusion: 1. age ≥ 18 years old; 2. patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of iol into the capsular bag; 3. preoperative corneal astigmatism ≤ 1.00d; 4. patient is willing and capable of providing informed consent; 5. patient is willing and capable of complying with visits and procedures as defined by this protocol. exclusion: 1. preoperative best corrected visual acuity \> 4.7 or ≤ 0.3 logmar; 2. corneal endothelial cell count less than 2000 cell/mm2; 3. age under 18 years old; 4. pregnant and lactating women; 5. patients who attend other drug or medical device study; 6. ocular disorder that could potentially cause a clinically significant future visual acuity loss; 7. anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 8. abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies); 9. any condition in the study eye that could affect iol stability (e.g. pseudo-exfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc; 10. any acute infection (acute ocular disease, external/internal infection, systemic infection); 11. history of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, microphthalmia, aniridia, epiretinal membrane etc.) in the study eye that could alter or limit final postoperative visual prognosis; 12. any previous intraocular and corneal surgery ; 13. uncontrolled glaucoma or iop higher than 24mmhg under ocular hypertension treatment; 14. current systemic or ocular pharmacotherapy that effects patients' vision; 15. current pathology or condition that could be a risk for the patient according to the investigator opinion; 16. patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation; 17. patients whose freedom is impaired by administrative or legal order.
early foley catheter removal after diverticular colovesical fistula repair

Conditions: Colovesical Fistula

Summary: patients undergoing surgical repair of colovesical fistula will have have "early" (post-operative day 3) cystogram and removal of bladder catheter. outcomes from the "early" group will be compared to historical "late" group data to determine if early bladder catheter removal is safe.

there is defined time for foley/bladder catheter removal after colovesical fistula repair in the current surgical literature. this study will be a prospective cohort study evaluating outcomes after early foley catheter removal (on post-operative day 3), specifically bladder leak, 30-day readmissions and adverse events. this cohort will be compared to a retrospective "late" group, who had foley catheter removal later in their hospital course.

Eligibility criteria:
inclusion criteria: * adults aged 18 and over * undergoing surgical repair of diverticular colovesical fistula exclusion criteria: * patients with active and untreated genitourinary cancers * subjects with known or suspected inflammatory bowel disease as the cause of colovesical fistula. * individuals who are not expected to regain normal bladder function after surgery as defined by either pre-existing bladder dysfunction with chronic indwelling urinary catheter, supra-pubic catheter, or surgical urinary diversion * individuals who require re-operation prior to foley removal * adults unable to consent * pregnant women * prisoners * individuals who are not yet adults (infants, children, teenagers less than 18 years old)
named patient use program to provide abemaciclib (ly2835219) for the treatment of metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the treating physician/investigator contacts lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.


Eligibility criteria:
inclusion criteria: * patients with hormone receptor positive metastatic breast cancer for whom there is reasonable expectation that abemaciclib may provide clinical benefit and who are suitable to receive abemaciclib.
translational study for obesity management in mexican adults using the "group lifestyle balance program"

Conditions: Obesity; Overweight

Summary: obesity is the main modifiable risk factor for the development of chronic diseases in mexico. several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity. these programs include frequent sessions (14 or more contacts in the first 6 months) focused on diet and physical activity and use a behavior change protocol. in mexico most primary care clinics and public hospitals apply traditional treatments for obesity management, which have limited effect on weight loss. this study would provide scientific evidence for an effective model for obesity management. objective. the purpose of this study is to evaluate the effectiveness of the "group lifestyle balance program" for overweight and obesity management in adults, in primary care clinics and public hospitals from sonora. this is a translational clinical study. healthcare providers from the participating clinics will be trained with the group lifestyle balance program before its implementation. the primary outcome measurement is the change in body weight from baseline to 6 months and 12 months. changes in body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in patients receiving the program before and 6 and 12 months after starting the program. additionally, biochemical parameters (fasting glucose, total cholesterol, ldl-cholesterol, hdl-cholesterol, triglycerides, fasting insulin, homeostatic model assessment- insulin resistance (homa-ir) and liver enzymes \[aspartate transaminase (ast), alanine aminotransferase (alt)\] will be evaluated from baseline to 12 months.


Eligibility criteria:
inclusion criteria: * adults (\>18 years of age and \<65) * overweight or obese (bmi \>25 kg/m2 y \<50 kg/m2) * availability and motivation to attend the intervention program * patients who would benefit from participating in the program according to the health providers * signing an informed consent exclusion criteria: * medical conditions affecting body weight significantly * pregnancy or nursing * bariatric surgery * being unable to participate in regular moderate physical activity * blood pressure \>160 mm/hg * hba1c\>9

Keywords: obesity translational diabetes prevention program group lifestyle balance program
doxapram administration on diaphragmatic excursion in mechanically ventilated patients with chronic obstructive pulmonary disease undergoing spontaneous breathing trial

Conditions: COPD; Mechanical Ventilation; Weaning From Mechanical Ventilation

Summary: researchers aim to evaluate the impact of doxapram administration on diaphragmatic excursion in chronic obstructive pulmonary disease (copd) patients undergoing spontaneous breathing trial

doxapram will be administered intravenously (iv) during spontaneous breathing trial. diaphragmatic excursion will be evaluated by an expert in respiratory muscle ultrasound

Eligibility criteria:
inclusion criteria: * patients with moderate to severe chronic obstructive pulmonary disease undergoing spontaneous breathing trial exclusion criteria: * refusal allergy to doxapram neuromuscular disorders inability to evaluate the diaphragm

Keywords: copd doxapram diaphragmatic excursion
a study of ramucirumab or icrucumab in colorectal cancer

Conditions: Colon Cancer; Rectal Cancer

Summary: the purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

the purpose of this study is to evaluate the progression-free survival (pfs) in participants with metastatic colorectal cancer when treated with 1 of 3 modified folfox-6 (folinic acid \[fa\] + fluorouracil \[5-fu\] + oxaliplatin \[mfolfox-6\])-based regimens, as second-line therapy. during 2010, there has been an identified shortage of injectable folinic acid (fa) in the united states. levo-folinic acid (lfa) will be allowed as a substitute for fa in the mfolfox-6 chemotherapy regimen in circumstances in which fa is not available, to facilitate continuity of participant care.

Eligibility criteria:
inclusion criteria: * disease progression on an irinotecan-based first-line chemotherapy regimen (ie folfiri or capiri \[capecitabine + irinotecan\], with or without bevacizumab) * age ≥ 18 years * life expectancy of ≥ 6 months * eastern cooperative oncology group performance status (ecog ps) 0-1 at study entry * agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication * provided signed informed consent exclusion criteria: * has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic colorectal cancer (crc) (prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered \> 12 months prior to randomization) * has documented and/or symptomatic brain or leptomeningeal metastases * has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders * on chronic non-topical corticosteroid treatment. a participant discontinuing such treatment \> 3 months prior to randomization is eligible * has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy * has a concurrent active malignancy. a participant with previous history of malignancy is eligible, provided that he/she has been disease free for \> 3 years * if female, is pregnant (confirmed by serum beta human chorionic gonadotropin \[βhcg\] test) or lactating * has received a prior autologous or allogeneic organ or tissue transplantation * has undergone major surgery within 28 days prior to randomization * has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization * has an elective or planned major surgery to be performed during the course of the trial * has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization

Keywords: colonic neoplasms rectal neoplasms adenocarcinoma antibodies, monoclonal
a study to evaluate add on effect of solifenacin in men with overactive bladder symptoms after tamsulosin monotherapy for 4 weeks

Conditions: Overactive Bladder

Summary: the purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.

this is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent oab symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for luts at a stable dose for 4 weeks in real life practice. also proportion of patients and predictive factors with persistent oab symptoms after tamsulosin monotherapy will be investigated.

Eligibility criteria:
inclusion criteria: * ipss ≥ 12 * symptoms of oab as verified by the v8 (≥8) * symptoms of oab as verified by the screening 3-day bladder diary, defined by: * mean urinary frequency ≥8 times/24 hours * mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a urinary sensation scale rating of ≥3 marked for the corresponding micturition in the bladder diary) exclusion criteria: * treatment within the 14 days preceding treatment with any alpha blocker drugs * a known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor

Keywords: solifenacin tamsulosin oab
pembrolizumab in progressive multifocal leukoencephalopathy (pml) in immunocompromised patients without hiv infection

Conditions: Progressive Multifocal Leukoencephalopathy

Summary: this study aims to assess the efficacy and safety of pembrolizumab in immunocompromised patients with progressive multifocal leukoencephalopathy (pml). this phase ii, multicenter, single-arm study includes patients with an underlying cause of immunosuppression hardly reversible, i.e. not the patients with hiv nor those receiving biologics for chronic inflammatory diseases. patients will receive intravenous pembrolizumab (2 mg/kg, maximum 200 mg) at month 0, 1 and 2 (total of three doses). the primary endpoint will be achieving at least one negative result of jcv viral load in cerebrospinal fluid (csf) within the m0 to m3 period.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. diagnosis of definite pml since less than 2 months according to american academy of neurology 3. presence of jcv in the csf in the last csf sampling. 4. signed informed consent (from the patient, or if unable to consent, from a surrogate) 5. for women of childbearing potential: negative serum or urine b-hcg test and agree to use a highly effective contraception methods during 8 months (i.e. until 6 months after end of experimental treatment) exclusion criteria: 1. patients in whom immune reconstitution is achievable (hiv infection - multiple sclerosis - auto-immune and inflammatory diseases) 2. patients who have received solid organ transplantation 3. hypersensitivity to the active substance or to any of the excipients 4. life expectancy less than 1 month 5. pregnancy or lactating women or planning birth during the study period 6. having previously been treated by anti-pd1mab 7. patient receiving il-2 or il-7 for the treatment of pml at inclusion 8. patient whose weight is \> 100kg 9. participation in other interventional study \[a patient already included in another interventional study for which the treatment can lead to an immunodepression can be included if: * the investigational treatment has been completed and there is no risk of drug interaction with the administration of pembrolizumab as defined in penalty study * if this does not alter the study's ability to evaluate the effect of pembrolizumab in terms of safety and efficacy (from the investigator's point of view)\] 10. patient without national health insurance, and patient on ame (state medical aid) 11. patient under guardianship or curatorship 12. patient deprived of their liberty by a judicial or administrative decision

Keywords: progressive multifocal leukoencephalopathy checkpoint inhibitors pembrolizumab
biomarkers in patients hospitalized with suspected acute myocardial infarction

Conditions: Myocardial Infarction, Acute

Summary: the concentration of troponins in plasma is used for diagnosing acute myocardial infarction. different types of heart-specific troponins can be measured and with different analytical methods. the primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin i in diagnosing acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * hospitalized at st. olavs hospital * blood sampled for troponin analysis due to suspicion of acute myocardial infarction without st-elevations on ecg less than 4 hours after admitted to the hospital exclusion criteria: * residency outside norway * does not understand norwegian

Keywords: troponin i myocardial infarction sensitivity and specificity receiver operation characteristics curve biomarkers
project lung cancer screening in southern denmark

Conditions: Lung Cancer

Summary: one thousand randomly selected voluntary citizens aged 60-74 years old, who are heavy current or former smokers with an increased risk of developing lung cancer may be included in the project. the participants will be identified through an initial questionnaire survey concerning smoking history and general health. project participants are offered a low-dose ct (ldct) scan annually for three consecutive years. in relation to the first scan, a lung function test will also be performed. the screening process will be evaluated for possible national implementation of a lung cancer screening program in denmark.

this pilot study is a prospective interventional feasibility study. the primary goal is to evaluate the impact on healthcare organization, administration of resources and costs, and thereby assessing the feasibility of implementing systematic screening for lung cancer among people at high risk in denmark (current or former heavy smokers). the pilot study will be performed on funen in the region of southern denmark and will run over three years (2024-2026). one thousand randomly selected participants aged 60-74 years old, who meet the screening criteria, will receive annual ldct scans for three consecutive years. data will be collected continuously throughout the study period. the analysis method will focus on descriptive statistics to display questionnaire response and participation rates, and assess the impact of screening on healthcare organization and resources. furthermore, the result including direct and indirect effects of the screening process (e.g. number of positive findings, false positive results, and follow-up rates). the analyses will also include healthcare economics including resource consumption as well as qualitative assessments to describe potential differences between the screening population versus a corresponding control group of heavy smokers. finally, the radiologists' assessments of the project's ldct scans are compared to the assessment of an artificially intelligent algorithm to explore the opportunities of supporting a future national screening program.

Eligibility criteria:
inclusion criteria: * heavy smokers (≥ 30 pack years) or citizens with a plcom2012 calculated 6-year risk of lung cancer \> 2%. * age: 60-74 years old * residence on funen and surrounding islands exclusion criteria: * cancer treatment or follow-up (except non melanoma skin cancer and similar low malignant cancers) within the past 12 months * ct scan performed within the past 12 months