Kornimate/medical-research-clean huggingface dataset:
remote ischaemic conditioning (ric) in heart failure

Conditions: Heart Failure With Preserved Ejection Fraction; Type 2 Diabetes; Dilated Cardiomyopathy

Summary: this study will test the impact of remote ischaemic conditioning combined with exercise on myocardial perfusion in patients with or at risk of heart failure

heart failure (hf) is a disease which affects the heart's ability to pump or fill with blood. it can affect a person's quality of life and their ability to exercise. recent work has shown that a reduction in the blood supply to the heart may contribute to the problem. it is therefore possible that improving the blood supply to the heart may help patients with hf. one possible way that this might be achieved is with a method called remote ischaemic conditioning (ric). this involves placing a cuff on a person's arm (identical to a blood pressure cuff) and inflating it for a few minutes to reduce the blood flow in a person's arm. this is thought to release chemicals into the bloodstream which can have positive effects on the heart. this has been studied in patients with other forms of heart disease, but is yet to be tested properly in patients with heart failure. it is hypothesized that combining the ric procedure with a low level of arm exercise may result in further improvements in the person's blood vessels and heart. this will be tested in a single-centre prospective study.

Eligibility criteria:
inclusion criteria: * age \&gt;18 years * ability to provide written consent * clinical diagnosis of hfpef (lvef ≥50%; symptoms and signs of heart failure \[hf\] caused by a structural and/or functional abnormality, and at least one: elevated natriuretic peptides; ambulatory; bnp ≥35 pg/ml or nt-probnp ≥125 pg/ml or hospitalised; bnp ≥100 pg/ml or nt-probnp ≥300 pg/ml, and objective evidence of cardiogenic pulmonary or systemic congestion) or stable type 2 diabetes (determined by formal diagnosis in hospital or gp case records with diagnostic oral glucose tolerance test or glycated haemoglobin level ≥6.5%) and with acc/aha stage b hf (structural disorder of the heart but no current or previous symptoms of hf) or confirmed diagnosis of dilated cardiomyopathy exclusion criteria: * absolute contraindications to mri or contrast (e.g. severe claustrophobia, pregnancy, ferromagnetic implants, inability to lie flat, severe renal impairment egfr\&lt;30ml/min/m2) * moderate to severe valvular heart disease * confirmed coronary artery disease (\&gt;50% narrowing in any major epicardial coronary artery on invasive or computed tomography coronary angiography, previous myocardial infarction, previous percutaneous intervention or coronary bypass surgery) * known arterial stenosis of the upper extremity
isglt2 inhibitor and a idpp -4 inhibitor in treatment of type 2 diabetes mellitus in patients treated with metformin (triad)

Conditions: Diabetes Mellitus, Type 2

Summary: the present study aims to evaluate the efficacy and safety of different combinations of oral antidiabetics in patients with inadequate glycemic control on metformin monotherapy.

this is a phase iii, multicenter, randomized, double-blind, double-dummy clinical trial to evaluate the efficacy and safety of the he fixed-dose combination in patients diagnosed with type 2 dm (diabetes mellitus), with or without cardiovascular or renal complications, and who did not reach the therapeutic goals of glycemic control with previous guidance on diet and physical exercise, on monotherapy with metformin at the maximum tolerated dose, and who, at the discretion of the investigator, may benefit from the addition of trial drugs. the trial will have a total duration of a maximum of 144 days (approximately 20 weeks), with a screening/run-in period of up to 4 weeks and 16 weeks (112 ± 4 days) of treatment. the trial will include a screening visit (v-1), a baseline randomisation visit (v0), three follow-up visits (v1, v2, v3) and a final visit (v4).

Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree with all the purposes of the trial, signing and dating the icf in two copies; * age equal to or over 18 years old and less than or equal to 80 years old * diagnosis of type 2 dm with uncontrolled glycemia with a history of hba1c ≥7.5% and ≤10.5% (up to 12 previous months) with previous guidance on diet and physical exercise and monotherapy with metformin at the maximum tolerated dose (≥1,000 mg/day, stable and without signs of intolerance in the last 12 weeks) and who, at the investigator's discretion, may benefit from the addition of the trial drugs exclusion criteria: * any clinical observation finding (clinical/physical assessment) or laboratory condition that is interpreted by the investigating physician as a risk to the research subject's participation in the clinical trial or the presence of uncontrolled chronic disease(s); * history of alcohol or illicit drug use disorder in the two years prior to the visit; * subjects who are pregnant, breastfeeding or planning to become pregnant, or female subjects of childbearing potential who are not using a reliable method of contraception; * known history of allergy or hypersensitivity to any of the trial treatments, or to the excipients in the formulas, or in case of rare hereditary diseases which may be incompatible with the excipients in the product formulas (such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption); * subjects with type 1 diabetes mellitus; * history of fasting blood glucose ≥ 270 mg/dl.
exhaustive french national registry of af ablation using pentaspline pulsed field ablation catheter

Conditions: Atrial Fibrillation

Summary: pulsed field ablation (pfa) is a nonthermal ablative modality using a strong electrical field created around a dedicated catheter to produce pores in the cellular membrane. as the amount of energy required to produce electroporation is highly tissue dependent, the atrial myocardium can be specifically targeted while sparing adjacent tissues. this new ablation modality could increase the safety of pulmonary vein isolation (pvi) procedures compared to pvi using thermal energies. the investigators aim to provide the first exhaustive nationwide registry using the pentaspline pfa catheter to treat atrial fibrillation patients.

this is a multicenter observational research project, that prospectively included patients undergoing a first time atrial fibrillation ablation using the farapulse technology (boston scientific) since the start of this technology in france. all patients treated with the farapulse technology for atrial fibrillation in france from march 2021 to february 29th of 2024 will be included in the registry. the number of participating centers is 33. a one-year and 2-year follow-up will be performed according to the standard practices of the different centers. the study duration will be 5 years.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years * patients who received catheter ablation for paroxysmal af, persistent af, or long-standing persistent af. exclusion criteria: * previous left atrial ablation. * patient's opposition to participating in this registry

Keywords: pulsed field ablation registry
a relative bioavailability study of metformin hcl tablets, 1000 mg under fasting conditions

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to demonstrate the relative bioequivalence of metformin hcl tablets, 1000 mg under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
selective dose escalation for esophageal cancer

Conditions: Esophageal Cancer

Summary: this prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (rt; 50.4 gy) with concurrent continuous infusion 5-fluorouracil (5-fu) and weekly carboplatin/paclitaxel. patients with less than complete response (cr) or partial response (pr) received dose escalation of radiation to 59.4 gy with the same chemotherapy.

we prospectively enrolled patients with t1-4, n0-1, m0-1a esophageal carcinoma to receive paclitaxel 45 mg/m2 iv over 1 hour and carboplatin auc 2 iv over 30 minutes on days 1, 8, 15, 22, 29 and 36. 5-fu 225mg/m2 was delivered as a continuous infusion on days 1-38. rt was given 1.8gy 5 days/wk for 5.5 wks (50.4gy in 28 fx). after 6-8 weeks, patients underwent repeat staging with computed tomography (ct) scan, endoscopic ultrasound (eus), and biopsy. patients with a positive biopsy, or less than pr by ct and eus, received a boost of 9 gy with the same concurrent chemotherapy. patients were followed every 4 months with ct/eus first year, every 6 months thereafter.

Eligibility criteria:
inclusion criteria: * t1-4, n0-1, m0-1a esophageal carcinoma exclusion criteria: * distant metastases

Keywords: esophageal cancer, chemotherapy, radiation
cyberknife stereotactic body radiation therapy for small hepatocellular carcinoma patients with decompensated cirrhosis

Conditions: Hepatocellular Carcinoma

Summary: the aim of our research is to evaluate the curative effect and safety of cyberknife stereotactic body radiation therapy in treating small hepatocellular carcinoma (hcc) patients with decompensated cirrhosis.


Eligibility criteria:
inclusion criteria: * primary hcc diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of hcc or by pathology * unfeasible or refusing to undergo other treatments; * residual normal liver volume ≥700 cc; * with decompensated cirrhosis (child-pugh b or c classification); * without portal vein tumor thrombus; * eastern cooperative oncology group (ecog) score 0-1; * distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm； * rejecting other therapies such as resection, liver transplantation, etc. * platelet count≥50 × 109/l, white blood count≥1.5 × 109/l; * patients infected with hepatitis b virus who are treated with adefovir or entecavir; patients infected with hepatitis c virus whose hcv dna are negative. exclusion criteria: * with tumor thrombus； * with extrahepatic metastasis; * with lymph node involvement.

Keywords: hepatocellular carcinoma cyberknife stereotactic body radiation therapy child-pugh b classification child-pugh c classification
tegoprazan- versus ppi-based h. pylori eradication

Conditions: H.Pylori Infection

Summary: in 2015, vonoprazan, a potassium-competitive blocker (p-cab), was launched in japan and used as an alternative for proton pump inhibitors (ppis) for eradicating helicobacter pylori. in recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to ppi treatment group. accordingly, the japanese helicobacter treatment guidelines recommend prescribing p-cab for eradication treatment. in 2018, a new p-cab, tegoprazan, was developed in korea and approved for gastric ulcer treatment. subsequently, it was proven effective in the treatment of reflux esophagitis compared to ppis in a non-inferiority clinical trial. p-cab can increase the gastric ph to 6 or higher within 7 hours after taking tegoprazan. because tegoprazan can be taken after meals, it can improve patient compliance for h. pylori eradication. unlike vonoprazan in japan, however, tegoprazan-based eradication in korean population was similar to conventional ppi-based treatment. to date, the eradication success rates of ppi and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups. bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. in h. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. recently, bismuth was added to the 2-week triple regimen to increase the first-line h. pylori eradication rate in countries with high antibiotic resistance. the h. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. the odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. in subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. however, there was no comparative analysis of ppis and tegoprazan in a bismuth-added triple therapy.

the investigators aim to evaluate the eradication success rate and treatment compliance between ppi and tegoprazan in first-line h. pylori treatment with adding bismuth.

Eligibility criteria:
inclusion criteria: * gastroscopy can be performed * h. pylori test and pathological analysis can be performed exclusion criteria: * age \ 80 years * anemia (serum hemoglobin level \< 10 g/dl) * severe systemic disease * advanced chronic liver disease * use of certain medications, including proton pump inhibitors, h2- receptor antagonists, or antibiotics * history of h. pylori eradication * drug allergy to antibiotics * history of gastric surgery * recent history of upper gastrointestinal bleeding
covid-19 vaccines associated malaise

Conditions: Vaccine Adverse Reaction

Summary: covid-19 vaccines induced malaise have recently been reported in the literature. our study aims to identify risk factors associated with the onset of covid-19 vaccines induced malaise and to assess if certain covid-19 vaccines could be more prone to cause malaise compared to influenza vaccines. to do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in vigibase®, the who pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all covid-19 vaccines on the market and malaise. demographic data were also analyzed.


Eligibility criteria:
inclusion criteria: * all adverse events reported in the who pharmacovigilance database exclusion criteria: * none
taxane acute pain syndrome (taps) in patients receiving taxane chemotherapy for breast or prostate cancer

Conditions: Acute Pain

Summary: the purpose of this study is to document what course of action physicians choose for their patients when they develop taxane acute pain syndrome (taps) and to identify patients at the greatest risk of taps by examining specific human genome markers such as single nucleotide polymorphisms (snps) and copy number variations (cnvs) that may explain the genetic (hereditary) component.


Eligibility criteria:
inclusion criteria: * diagnosed with either invasive breast or prostate cancer (stage i-iv) * age ≥18 years * ecog performance status ≤2 * scheduled to receive intravenous taxane-based chemotherapy for either adjuvant or metastatic disease * participants need to have ability to complete questionnaires by themselves or with assistance and have the ability to provide informed written consent exclusion criteria: * concurrent use of any agents to try to prevent or treat neuropathy or taps, including gabapentin, glutamine, vitamin b6, and vitamin e. * pre-existing history of peripheral neuropathy greater than grade 1 nci ctcae version 4.0 from any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.) other medical conditions that would make study participation unreasonably hazardous * uncontrolled diabetes * medical or psychiatric illness that would interfere with patients' ability to complete the diary

Keywords: pain
alpco calprotectin elisa - measurement of calprotectin levels in human stool

Conditions: Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Summary: the alpco calprotectin elisa is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. calprotectin is a protein biomarker of mucosal inflammation. measurement of calprotectin can aid in the diagnosis of inflammatory bowel diseases (ibd), specifically crohn's disease (cd) and ulcerative colitis (uc), as well as aid in the differentiation of ibd from irritable bowel syndrome (ibs) when used in conjunction with other diagnostic testing and the total clinical picture. this study will estimate the predictive values of a negative (npv) and positive (ppv) test by utilizing the assay outcomes of the alpco calprotectin elisa.


Eligibility criteria:
inclusion criteria: inclusion criteria (ibd or ibs subjects): * \>18 years of age * patient must present with signs and symptoms of ibs or ibd * patient must be scheduled for a colonoscopy * all results of the colonoscopy including histology must be provided to study site and sponsor. * medical chart review may be required to confirm diagnosis of ibs or ibd * patient must not have taken nsaids for at least 2 weeks prior to participating in the study. patients may be advised of the study and if report taking nsaids may be enrolled in the study after the patient has stopped use of nsaids for a minimum of 2 weeks. * for normal patient population - study participants must present with no signs or symptoms of ibs or ibd, must not have taken nsaids for at least a period of 2 weeks and must be willing to provide a stool sample. * sample must be collected at least 2-3 days prior to colonoscopy inclusion criteria (normal subjects): * male or female, ≥18 years of age. * no abdominal complaints and no history of ibs, ibd, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment. * may have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy. * able to understand the study and the task required, and sign the icf. exclusion criteria: exclusion criteria (ibd or ibs subjects): * patient under the age of 18 * patient taking nsaids * patients not presenting with signs or symptoms of ibs or ibd with the exception of 100 normal patients to be included in the study. fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy. * patients not scheduled to have an colonoscopy unless enrolled in the study as normal population exclusion criteria (normal subjects): * unable or unwilling to provide a stool specimen. * have taken protein pump inhibitors (ppis) or h2-receptor antagonists for control of upper gi disease within the previous 2 weeks. * have taken nsaids (including aspirin) on within 2 weeks of study enrollment.
aclidinium bromide post-authorisation safety study to evaluate the risk of cardiovascular endpoints

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the potential cardiovascular safety concerns and all-cause mortality described in the risk management plan for aclidinium bromide, through sequential, nested case-control studies for each endpoint of interest

this is a post-authorisation safety study (pass) of new users of aclidinium bromide, fixed dose aclidinium bromide/formoterol fumarate dihydrate, and other inhaled medications frequently used by patients with copd the plan is for the pass study to be conducted on one population-based automated health database; the initial candidate database is the crpd in the united kingdom.

Eligibility criteria:
inclusion criteria: 1. have at least 1 year of enrolment in the electronic database. in the cprd, only patients with permanent registration status in "up to standard" participant general practices will be included in the cohort. 2. be aged 40 years or older. 3. have a recorded diagnosis of copd. 4. have not been prescribed a study medication of interest during the 6 months before the date of the first prescription for that specific study medication. exclusion criteria: 1. patients with cancer or other serious, non-cardiovascular, life-threatening conditions or indicators of severe comorbidity will be excluded from the study cohort. 2. subjects who will be potentially excluded are those with the following conditions recorded in the database at any time before the date of cohort entry: cancer, hiv, respiratory failure, end-stage renal disease or dialysis, organ transplantation, drug or alcohol abuse, coma, congenital abnormalities of the heart or great arteries.

Keywords: copd
covid-19 and intestinal microbiota in children

Conditions: SARS-CoV2 Infection, COVID-19, Gut Microbiota, Mucosal Response, Children

Summary: sars-cov-2 is the causative agent of the covid-19 pandemic. it appears to cause only mild to moderate upper respiratory symptoms in children, in addition to gastrointestinal symptoms resulting from its penetration into intestinal cells. viral respiratory infections are often accompanied by a change in the composition of the gut microbiota (gm). additionally, intestinal metabolites and integrity appear to be altered. this work aims to study the composition of the gm of lebanese children, currently (n=14) and previously (n=33) infected with sars-cov-2 and to compare it to pre-pandemic controls (n=39). furthermore, the correlation between the composition of the gm and the intestinal homeostasis are evaluated. clinical data and stool samples were collected from children aged 1 month to 12 years. the bacterial profile is determined by quantitative pcr and 16s rrna sequencing. levels of secretory immunoglobulin a (siga), fecal calprotectin, beta defensin type 2 (hbd-2), short-chain fatty acids (scfas), tryptophan derivatives, and bile acids are also evaluated. given the well-established relationship between the gm and the immune system, the results of this study could serve as a potential basis for the implementation of personalized nutrition and biotic supplementations aimed at restoring the host-microbiota symbiosis, pointing to the prevention and treatment of covid-19


Eligibility criteria:
inclusion criteria: * within age limits * positive pcr exclusion criteria: * metabolic disorders, hepatic disorders, immunodeficiency, allergy, autoimmune diseases, ibd, food intolerance, antibiotic administration within 3 months, pro and prebiotic administration within 3 months