Kornimate/medical-research-clean huggingface dataset:
metformin efficacy and safety for gastric intestinal metaplasia

Conditions: Gastric Intestinal Metaplasia

Summary: gastric intestinal metaplasia significantly increases the risk of gastric cancer. metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested to have a suppressive effect on tumorigenesis and cancer cell growth. the investigators devised a prospective randomized controlled trial to evaluate the chemopreventive effect of metformin against gastric intestinal metaplasia and the safety of this drug in non-diabetic gastric intestinal metaplasia patients.


Eligibility criteria:
inclusion criteria: 1. patients aged from 18 to 75 years old; 2. body mass index (bmi) ranged from 18.5 to 23.9 at enrollment; 3. im patients with olgim stage ⅱ-ⅲ diagnosed by upper gastrointestinal endoscopy and histopathological biopsy within the last 3 months; 4. patients without h. pylori infection confirmed by 13c-urea breath test (ubt) or patients with h. pylori infection who completed the bismuth-containing quadruple program and had confirmed successful eradication by 13c-ubt. exclusion criteria: 1. history of diabetes mellitus (use of medication and/or hba1c over 6.5%); 2. history of regular use (defined as at least once per week) of nsaids and/or aspirin; 3. history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor; 4. history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; 5. patients with contraindications or allergies to the drugs in this study; 6. breastfeeding or pregnancy; 7. history of substance abuse or alcohol abuse in the past 1 year; 8. severe mental illness; 9. refusal of drug treatment; 10. refusal of signing informed consent.
header burden in football (soccer)

Conditions: Header Frequencies, Head Injuries

Summary: to assess the realistic magnitude of the header burden in children's and youth' football in eight european countries. in a cross-sectional observational design, one match of 60 different teams in each of the eight european countries were monitored via video recording throughout the second half of the regular season 2017/18 and the first half of the regular season 2018/19. clubs with (female, male, or mixed) under-10, under-12 and female and male under-16 teams were invited to participate. header frequencies and types were analysed using standardized heading registration forms. additionally, head injuries were recorded using standardized head injury registration forms.


Eligibility criteria:
inclusion criteria: * 1) officially registered in the football association * 2) regular training participation * 3) regular participation in official matches
non-invasive diagnostic for assessing elevated intracranial pressure

Conditions: Intracranial Pressure Increase

Summary: the study is a prospective, multi-center, non-randomized, open label observational study. the objective of this study is to compare the accuracy of the eyebox to a clinical diagnosis of abnormal icp as determined by an external ventriculostomy drain (evd) or ventriculostomy catheter.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent. 2. require placement of an icp monitor or ventriculostomy catheter for clinical purposes. 3. be between the ages of 4 and 70 years old. 4. have baseline vision correctable to within 20/500 bilaterally. 5. have no prior history of ocular dysmotility. 6. be awake with spontaneous eye opening at the time when eye tracking is performed. exclusion criteria: 1. have a prior history of strabismus, diplopia, or palsy of cn-iii, iv or vi. 2. be blind (no light perception), have missing eyes, be unable to open their eyes. 3. have a prior history of ocular motility dysfunction. 4. have had extensive prior eye surgery. 5. have any physical or mental injury or baseline disability rendering task completion difficult. 6. be intoxicated or have blood alcohol level greater than 0.2. 7. be a prisoner or in the company of a police officer or law enforcement officer pending arrest.

Keywords: noninvasive diagnosis
a study to evaluate the efficacy and safety of gdc-8264 in preventing cardiac surgery-associated acute kidney injury (aki) and major adverse kidney events (make)

Conditions: Acute Kidney Injury

Summary: the aim of this study is to evaluate the efficacy and safety of gdc-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing aki and subsequent make at 90 days after surgery (make90). the study will be performed in two parts- part 1 and part 2.


Eligibility criteria:
inclusion criteria: 1. one of the following non-emergent cardiac surgery types that requires cardiopulmonary bypass (cpb) to be done in one procedure rather than separate procedures: isolated coronary artery bypass grafting (cabg); isolated surgical aortic valve replacement (avr), mitral valve replacement (mvr), mitral valve repair (mvr); combined cabg+avr, cabg+mvr, cabg+mvr, avr+mvr, avr+mvr 2. at least one or at least two of the following aki risk factors, depending on the type of surgery: age \> 70 years, history of ckd with egfr \< 60 milliliters/ minutes/ 1.73 meter square (ml/min/1.73 m\^2) within the last 6 months, diabetes (type 1 or type 2) requiring at least one oral hypoglycemic agent or insulin, history of chronic obstructive pulmonary disease (copd) requiring medical therapy, left ventricular ejection fraction (lvef) \< 40%, preoperative anemia \[hemoglobin \<10 grams/deciliters (g/dl)\] 3. stable kidney function with no known episodes of aki within 2 weeks of screening exclusion criteria: 1. need for renal replacement therapy (peritoneal dialysis or hemodialysis) 2. need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery 3. presence of a durable left ventricular assist device 4. need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects 5. heart transplant 6. transcatheter valve replacements 7. hypotension or shock requiring hospital admission 8. cardiopulmonary resuscitation 9. egfr \< 20 ml/min/1.73 m\^2 10. heart failure with ejection fraction \< 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening 11. history of kidney transplant or only one kidney (due to donation) 12. renal agenesis, total nephrectomy, or partial nephrectomy of \> 50%
strength training for chronic stroke patients

Conditions: Stroke

Summary: the study aims to investigate the effects of strength training on maximal strength, walking ability and neural function in chronic stroke patients. the strength training intervention in this study is different to all previous interventions for stroke patients. maximal strength training (mst) involves weights of up to 90% of the participants 1 repetition maximum and has a focus on the explosive development of force. this study will use these principles for unilateral leg press and plantarflexion exercises. only 2 previous studies have investigated high intensity strength training for stroke patients and they used intensities of 80% 1rm. previous mst interventions have shown large increases in strength, rate of force development and this has transferred to improved walking economy. the investigators predict that mst will give large increases in strength, improved rate of force development (rfd) and walking economy. the investigators expect that better neural function will account for the improvements. this study could provide evidence for the adoption of a completely different method of strength rehabilitation for stroke survivors.


Eligibility criteria:
inclusion criteria: * under 67 years old * suffered from a stroke at least 6 months previously * living in the trondheim area such that travel costs can be covered by 1500 nok * must be able to walk, although use of aids is permitted exclusion criteria: * participants must not have cognitive, visuospatial or comprehension deficits to magnitude such that it interferes with the ability to perform testing and training * participants must be medically unstable (e.g. uncontrollably high blood pressure (140/90), arrythmia, other heart instabilities or other known comorbid diseases) * participants must not be known to be pregnant

Keywords: stroke strength training exercise therapy
early-myo-cmr registry

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Summary: the purpose of this registry is to depict the myocardial tissue characteristics in stemi patients by cmr and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. information will be collected prospectively in about 1000 stemi patients in 10 sites. subjects will be followed for up to 5 years.

this is a prospective, multi-center, non-randomized, observational registry study of stemi patients that undergo cmr examination. information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. this project will establish a prospective registry of 1000 stemi patients in 10 sites with follow-ups of up to 5 years. the aim of the project will be as following: 1. to investigate myocardial tissue features and functional changes in stemi patients. 2. to identify cmr-derived indices that are associated with adverse clinical outcomes. 3. to compare cmr with other alternative cardiac imaging modalities (i.e., echocardiography or spect) on prognostic prediction in stemi patients. 4. to compare myocardial tissue characteristics and functional changes in stemi and nstemi patients (data derived from early-myo-cmr ii registry).

Eligibility criteria:
inclusion criteria: stemi patients who have had cmr imaging performed and have provided written consent. 1. patents older than 18 years old with myocardial infarction diagnosed by: 1. typical ischemic symptom, 2. new ischaemic ecg changes;: ≥2 mm st-segment elevation in 2 contiguous precordial leads or ≥1 mm st-segment elevation in 2 contiguous extremity leads ; 3. elevated cardiac troponin value with at least one value above 99th percentile upper reference limit(upl); 4. confirmed by coronary angiography (cag) or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology. 2. patients who have had cmr imaging performed and have agreed to comply with the follow up requirements. exclusion criteria: 1. patient who is unable to comply with the follow-up schedule. 2. patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study. 3. patient has a life expectancy of less than 6 months due to any condition.
testing crizotinib as a potential targeted treatment in cancers with ros1 genetic changes (match-subprotocol g)

Conditions: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma

Summary: this phase ii match treatment trial identifies the effects of crizotinib in patients whose cancer has a genetic change called ros1 translocation. crizotinib may block a protein called ros1, which may be needed for cancer cell growth. researchers hope to learn if crizotinib will shrink this type of cancer or stop its growth.

primary objective: i. to evaluate the proportion of patients with objective response (or) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma. secondary objectives: i. to evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma. ii. to evaluate time until death or disease progression. iii. to identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (rna), protein and imaging-based assessment platforms. iv. to assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens. outline: patients receive crizotinib orally (po) twice daily (bid) on days 1-28. cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.

Eligibility criteria:
inclusion criteria: * patients must have met applicable eligibility criteria in the master match protocol prior to registration to treatment subprotocol * patients must be positive for translocation or inversion events involving the ros1 gene via the match master protocol * patients must have an electrocardiogram (ecg) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ecg (e.g. complete left bundle branch block, third degree heart block) exclusion criteria: * patients must not have nsclc with ros1 rearrangements * patients with a history of interstitial lung disease or pneumonitis are excluded * patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition * patients using drugs or foods that are known potent cyp3a4 inhibitors or inducers will be excluded * patients must not have had prior therapy with any ros1 inhibitor including crizotinib, ceritinib, foretinib, cabozantinib, ap26113, asp3026, wz-5-126, tae684, kist301072, kist301080, azd1480, pf-06463922, rxdx-101 and pf-3922
eus guided transduodenal biopsy using the 19g flex

Conditions: Abdominal Neoplasms

Summary: this study evaluates the feasibility, safety and accuracy of a 19 gauge (19g) needle in nitinol in the performance of endoscopic ultrasound (eus) guided transduodenal biopsy for the acquisition of samples for histologic analysis. patients with lesions that can be approached only from the duodenum will be prospectively enrolled.

a 19 gauge needle in nitinol (flex needle) has been recently become available for eus guided procedure. the use of nitinol should guarantee a better needle flexibility with a theoretical advantage on the use of this needle for lesions that need to be sampled through the duodenum. moreover, samples for histologic examination seems to be easy to interpret than cytologic ones allowing evaluate of the overall architecture of the tissue, better performance of immunohistochemical staining, and may be of additional value to perform tissue profiling that in the future will be very important to guide individualized therapies the existing data on the performance of the flex needle for eus-guided transduodenal biopsy are coming form a single study performed in one single center. thus, the reproducibility of these results is unknown and multicenter prospective studies are warranted to answer this important question.

Eligibility criteria:
inclusion criteria: a. age greater than 18 and less than 90. b. presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis. c. absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (pt) or partial thromboplastin time (ptt) that does not normalize after administration of fresh frozen plasma. d. informed consent is obtained. exclusion criteria: a. presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (pt) or partial thromboplastin time (ptt) that does not normalize after administration of fresh frozen plasma. b. altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum. c. they are unable to understand and/or read the consent form.

Keywords: eus-guided biopsy, eus-fnb
survey of buprenorphine use among "out of care" population in france (p04933)(completed)

Conditions: Drug Addiction

Summary: this study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month. subjects were surveyed at various locations (streets, railway stations, etc.) with a few simple questions in order to describe the use of buprenorphine in this "out of care" population.

participants were found from various places and using a "snow ball" technique.

Eligibility criteria:
inclusion criteria: * drug users who have obtained buprenorphine only on the black market or both on black market and in pharmacy. exclusion criteria: * patients who have obtained buprenorphine only from the pharmacy.

Keywords: heroin buprenorphine use
adult asthmatics and acid reflux

Conditions: Asthma

Summary: the purpose of this study is to assess the efficacy and safety of nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma * forced expiratory volume and peak expiratory flow as defined by the protocol * daily use of inhaled gcs and/or leukotriene pathway modifier for greater than 3 months. * severe heartburn 3 days/week during the run-in period. exclusion criteria: * subjects with a history of 3 sinus infections treated with antibiotics in the year prior to visit 1. * any other significant disease or pathology judged to be clinically significant by the investigator

Keywords: asthma acid reflux nexium esomeprazole
comparison of measured to predicted resting metabolism

Conditions: Body Weight

Summary: the purpose of this study is to compare rmr values from the bia, predicted equations, and indirect calorimetry.

resting metabolic rate (rmr) describes the number of calories a person utilizes while at rest. the gold standard measurement is via inspired and expired air using a metabolic cart. however, researchers have established estimation equations and the use of body composition analysis to predict rmr when a metabolic cart is unavailable. the accuracy of the predicted equations and whole-body bioelectrical impedance (bia) machines that produce this data is unknown. therefore, the purpose of this study is to compare rmr values from the bia, predicted equations, and indirect calorimetry. aim 1: to compare measured rmr from indirect calorimetry to values provided by the inbody 770 bia machine and to established gender and age-appropriate prediction equations. aim 2: to compare rmr measured from indirect calorimetry using a metabolic cart (gold standard) to the medgem handheld indirect calorimeter (fda approved device).

Eligibility criteria:
inclusion criteria: * men \& women, aged 18-60 exclusion criteria: * have any known or suspected metabolic diseases such as diabetes, thyroid disorder, or high cholesterol * have any known or suspected cardiovascular or pulmonary diseases such as hypertension * are currently on beta blockers, taking antihypertensives, or antidepressants * current smoker or quit less than a year ago * unwilling to provide finger stick and urine sample
randomized controlled trial of regulation-focused psychotherapy (rfp-c)

Conditions: Childhood Externalizing Disorder; Childhood Oppositional Defiant Disorder; Childhood Conduct Disorder

Summary: regulation focused psychotherapy for children (rfp-c) is a manualized, time-limited psychodynamic treatment for children with externalizing symptoms. rfp-c also holds the potential to treat a wider range of psychopathology, including comorbid internalizing conditions, because it aims to improve emotion regulation which is a transdiagnostic component of childhood mental health. this study will replicate previous findings supporting the efficacy of rfp-c. it will test the effectiveness of rfp-c in parallel groups via a pragmatic randomized controlled trial (rct) conducted at istanbul bilgi university's outpatient clinic in istanbul, turkey with a sample of 80 children with externalizing and comorbid internalizing/externalizing problems in comparison to a parental awareness and child social skills group. primary outcomes will be child externalizing problems and oppositional defiance problems. the treatment's effectiveness and change mechanisms will be investigated both at the end of treatment (primary endpoint) and at 6-month follow-up (secondary endpoint). the project results will provide preliminary answers about the active ingredients of rfp-c, help improve therapeutic interventions, and design optimal treatments for externalizing problems.


Eligibility criteria:
inclusion criteria: 1. children must be between the ages of 6-12 years of age 2. meet criteria for clinical levels of externalizing problems on the sdq 3. parent(s) able to attend four sessions of parent meetings exclusion criteria: 1. solely emotional problems and non-clinical problem levels (as assessed by the sdq) 2. primary diagnosis of psychosis or eating disorders (as assessed by ksads-pl) 3. risk for suicide and/or severe violence risk (as assessed by ksads-pl) 4. current enrollment in another psychosocial treatment 5. intellectual disability or major developmental delay (e.g. moderate/severe autism spectrum disorder) (as assessed by ksads-pl \& wasi) 6. families with high risk of domestic abuse 7. parents with acute psychosis (as assessed by scid) 8. parents with severe substance abuse and dependence (as assessed by scid) 9. parents with intellectual disability (as assessed by wasi) 10. parents with acute risk of harm to self and others (as assessed by scid)

Keywords: regulation focused psychotherapy implicit emotion regulation externalizing problems
efficacy and safety of adjunctive use of rifaximin in preventing radiotherapy-induced diarrhea in cancer patients

Conditions: Radiotherapy Induced Diarrhea; Acute Radiation Enteritis; Prostate Cancer; Cervical Adenocarcinoma; Bladder (Urothelial, Transitional Cell) Cancer; Rectal Adenocarcinoma; Pelvic Radiotherapy; Rifaximin

Summary: preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. so, the aim of the work is to investigate the impact of rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.


Eligibility criteria:
inclusion criteria: * individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers. * patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment. exclusion criteria: * patients who have a record of intestinal resection in their medical history. * patients with a medical background of irritable bowel syndrome. * patients with a history of inflammatory bowel disease. * patients who regularly take anti-diarrheal medications before commencing radiotherapy. * patients experiencing diarrhea at the outset of the study. * patients with compromised immune systems, such as those who are hiv positive or using immunosuppressive medications. * pregnant or lactating woman. * patients allergic to rifamycin.