Kornimate/medical-research-clean huggingface dataset:
targeted potassium levels for prevention of icd therapy

Conditions: Ventricular Arrhythmias and Cardiac Arrest; Implantable Defibrillator User; Hypokalemia; Hyperkalemia; Ventricular Tachycardia; Atrial Fibrillation

Summary: this study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 meq/l) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower incidence of cardiac arrhythmias in patients with an icd. patients will be randomized to this treatment or a control arm, where patients will receive usual guideline recommended follow-up.

there is solid evidence that potassium-sparing drugs increase survival and ameliorates symptoms in heart failure patients and post-hoc studies have suggested that high-normal levels of blood potassium levels (p-k) markedly decreases the risk of malignant arrhythmias in cardiovascular patients. this trial will randomize patients implanted with implantable cardioverter defibrillators (icds), who remain at high risk of life-threatening cardiac arrhythmias, to a standard therapy or standard therapy plus a regimen to keep high-normal p-k levels. the study will enroll 1,000 patients from the outpatient pacemaker clinics at rigshospitalet and gentofte hospital. using a planned regime to increase p-k using inexpensive drugs and potassium supplements, the patients enrolled and followed with regular controls as well as continuous monitoring using existing home monitoring systems over a period of 4 years for the primary endpoint of appropriate icd therapy and all cause mortality. including analysis, the trial will be running for 5 years

Eligibility criteria:
inclusion criteria: * implantable cardioverter defibrillator (icd) or cardiac resynchronization pacemaker with icd (crt-d). * age \>18 years exclusion criteria: * estimated glomerular filtration rate (egfr) \<30 ml/h * pregnancy * lack of ability to understand and sign informed consent
stentys xposition s in the treatment of chronic total artery occlusion

Conditions: Chronic Total Occlusion; Coronary Artery Disease

Summary: intro: chronic total occlusions (cto) are the most severe coronary lesions. negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. treatment of cto with percutaneous coronary intervention (pci) is associated with good clinical outcomes. however, qca and ivus studies showed a notable lumen and vessel enlargement distal to recanalized cto. in addition, optical tomography (oct) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after cto pci. the stentys xposition s is a self-apposing stent device which lowers stent strut malapposition rates. its safety and effectiveness has been demonstrated in stemi and stable coronary patients but never investigated in cto lesions. hypothesis/objective to investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with cto undergoing percutaneous coronary intervention. method pilot randomized study. patients are randomized to receive either self-expandable stent or balloon expandable stent to perform cto-pci. follow-up coronary angiography is performed at 6 months post-pci. stent malapposition is evaluated by oct.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * cto referred for pci * diameter of the target vessel for pci between 2.5 and 4.5mm * agreement to participate and signed informed consent after information * affiliation to social security system * french comprehension exclusion criteria: * pregnant women, breast-feeding, * history of an allergic reaction or significant sensitivity to any stent component or to contrast dye * intrastent cto * major calcifications in the cto * inclusion in another interventional study * person under guardianship or curatorship

Keywords: chronic total occlusion self-expandable stent percutaneous coronary intervention coronary artery disease
oral lactobacillus supplementation as treatment for overactive bladder syndrome: a randomised controlled trial

Conditions: Overactive Bladder Syndrome

Summary: background: overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence. overactive bladder affects approximately 13% of older women and thus represents a condition with high prevalence. affected women report significant limitations in daily life, as well as social isolation. despite the high occurrence of this condition, therapeutic options are limited, partly because the etiology of this condition is not fully understood. increasingly, studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition. therefore, the aim of this study is to test, whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms. design: randomized controlled study methods: intake of omni biotic® 41167 or placebo twice daily for 6 months; swabs (vaginal and urethral) and urine samples from a single-use catheter for microbiome determination at 0, 3, and 7 months. outcome: reduction of subjective symptoms (yes/no) after 3 and 7 months; reduction of overactive bladder symptom score after 3 and 7 months; change in the urogenital microbiome after 3 and 7 months (comparison of intervention vs. placebo).


Eligibility criteria:
inclusion criteria: * diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms exclusion criteria: * under age 18 * neurogenic overactive bladder
does bloody urine predict urethrovesical anastomosis leakage after radical prostatectomy

Conditions: Prostatic Neoplasm; Anastomosis

Summary: traditionally the watertightness of urethrovesical anastomosis after robotic radical prostatectomy is controlled by cystogram. however, clinical observations and one previous study showed that patients with anastomotic leakage have red coloured urine. if the investigators can verify this finding, the most of the cystograms can be avoided. in this study the investigators estimate urine colour after cystogram and take a picture from urine collecting pag. later on the pictures are digitally analyzed and compared to cystogram finding.


Eligibility criteria:
inclusion criteria: * previous robotic radical prostatectomy * catheter removal visit exclusion criteria: * no urine in urinary collecting bag
vsl#3® vs placebo in the treatment of fatigue and other symptoms in long covid (delong#3)

Conditions: Long COVID

Summary: this study aims to evaluate the effectiveness of vsl#3® in reducing fatigue and other symptoms in long covid syndrome compared to placebo.

long covid syndrome is a chronic condition characterized by persistent symptoms experienced by individuals who have recovered from acute coronavirus disease (covid-19). among the various symptoms reported, fatigue stands out as a particularly burdensome and pervasive issue, significantly impacting the quality of life and daily functioning of long covid patients. recent studies report that gut microbiota is altered during acute illness and not restored even after several months from recovery. based on this evidence, modulation of intestinal microbiota can be considered as a possible therapeutic approach for long covid syndrome. on this basis, the aim of this study is to evaluate efficacy of vsl#3® compared to placebo in reducing fatigue in long covid symptoms.

Eligibility criteria:
inclusion criteria: * age \>18; \<65 yo * previous diagnosis of sars-cov-2 infection, documented by nasopharyngeal or antigenic molecular swab; * not currently be in quarantine or isolation; * no antibiotics treatment in the 30 days prior to the trial; * chalder fatigue scale (in dichotomous form)\>=4 possibly associated with signs and symptoms of long covid-19 syndrome: signs and symptoms that develop during or after sars-cov-2 infection, which persist for more than 4 weeks and are not reasonably explained otherwise; signs and symptoms include: fatigue, sleep disturbances, cognitive deficits (i.e. brain fogging, loss of concentration and memory, anxiety, depression), strength deficits, arthralgias and myalgias, gastroenterological alterations (reduced appetite, nausea, changes in bowel habits, abdominal pain exclusion criteria: * cardiovascular and pulmonary disease with moderately severe organ dysfunction (nyha\>2, borg scale\>=2); * decompensated endocrine and metabolic diseases (child cirrhosis \>= b, decompensated hypo/hyperthyroidism, decompensated hypoadrenalism) * diagnosis of fm, cfs/me, and/or ibs prior to sars-cov-2 infection; * confirmed diagnoses of neurological pathologies, psychiatric diseases and cognitive disorders prior to sars-cov-2 infection; * previous confirmed diagnosis of chronic musculoskeletal pathologies prior to prior to sars-cov-2 infection; * refusal to participate in the study / refusal to process personal data; * pregnancy or breastfeeding; * addiction to alcohol or drugs in previous years; * use of other probiotics during the trial; * use of antibiotics during the trial and in the previous 30 days; * substantial change of diet during the trial; * participation in another clinical study in the previous 30 days or previous participation in this same trial; * known intolerance/hypersensitivity to the investigational drug or to the excipients of the placebo formulation

Keywords: long covid fatigue gut microbioma dysbiosis covid-19 coronavirus infections
covid-19 recovery study: symptoms and biomarkers of long covid-19 in people living with and without hiv

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2); HIV

Summary: this observational study will prospectively characterize the long-term symptoms and side effects of covid-19 in cohorts of people living with and without hiv. this will be achieved through a series of remote study visits involving completing surveys about health history, symptoms, mood, quality of life and changes in health, and up to two blood draws from home through the use of a mobile phlebotomy service.

this is a prospective observational study being conducted to learn about late (2+ weeks or more) effects of covid-19 in people living with and without hiv. the investigators plan to do this by studying people who have covid-19 and people who have not had covid-19, and by studying people living with hiv and people who are hiv-negative. the investigators will investigate the average duration of symptoms after covid-19, how these symptoms affect quality of life, and what medical complications are common after covid-19 in people with and without hiv. participation involves: * participant completion of surveys about themselves, their health history, their quality of life and mood in the recent past, and about covid-19 or hiv if the participant has a history of either infection. the investigators will ask participants to answer questions in up to 5 follow-up surveys over the course of a year about their symptoms, mood, quality of life, and changes in health. participants will also complete a series of short tests of thinking, memory, and reaction speed at certain follow-up surveys. * up to two visits to the participant's home (or an acceptable location of their choosing) by a phlebotomist. the phlebotomist will collect about 3.5 tablespoons of blood, as well as measure height, weight, and vital signs when laying down and standing up. this is a fully remote study and all study activities can be done from home or another location of the participant's choosing.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * living within the contiguous 48 states * groups 1 and 3: self-reported hiv infection * groups 2 and 4: self-reported hiv negative exclusion criteria: * inability to communicate by telephone in english or spanish * inability to complete required study events * a first or only diagnosis of covid-19 5 or more weeks prior to first contact with participant * groups 3 and 4: diagnosis of covid-19 ever, or participant suspects they had covid-19 at any time regardless of whether they were tested

Keywords: covid-19 long covid hiv
telomere length in relation to acute stress response in critical care patients

Conditions: Acute Disease; Telomere Shortening

Summary: the investigators studied the impact of severe stress (in this case any event or illness leading to a necessity of critical care) on telomere length.

telomeres length analysis were determined from 2 blood samples, the initial sample drawn in the first 72 hours after hospitalization and the second after not \ 14 days. for patients discharged before day 5, a repeat sample was drawn and analyzed on the discharge day. the blood sample processing was as follows: 5 ml of blood was collected and the red blood cells (rbc) were lysed using the rbc lysis solution (biological industries, beit haemek, israel). isolation of genomic dna was performed by using the dna isolation kit for mammalian blood (roche, mannheim, germany). briefly, dna was isolated by the salting out procedure, washed and precipitated by isopropanol. the dna was resuspended in polymerase chain reaction (pcr) grade water. the dna concentration was measured by using the nanodrop device (thermo fisher, usa). dna samples were analyzed for telomere length according to the method of cawthon (2009) \[20\] with slight modifications. each dna sample was analyzed by two sets of primers detailed below, one for telomere length analysis and one for a reference gene analysis (human hemoglobin). the primers were diluted to 100µm in pcr grade water and then to 10µm. dna samples were diluted to 2.5 ng/µl in pcr grade water. the primers sequences are shown below: telc: tgttaggtatccctatccctatccctatccctatccctaaca telg: acactaaggtttgggtttgggtttgggtttgggttagtgt hbgd:_gcccggcccgccgcgcccgtcccgccggaggagaagtctgccgtt hbgu: ggcggcgggcggcgcgggctgggcggcttcatccacgttcaccttg reaction pcr were processed as follows: 50°c for 2 min, 95°c for 5 min, a single cycle of 94°c for 15 sec, 49°c for 15 sec; 40 cycles of: 94°c for 15sec, 62°c for 10 sec and a final stage of: 74°c for 15 sec. all reactions were performed using the step one device (abi, usa).

Eligibility criteria:
inclusion criteria: * • patients hospitalized up to 72 hours prior to admission to the icu * predicted icu stay is at least 5 days exclusion criteria: * • pregnancy and lactation
a study of tocilizumab (roactemra/actemra) in patients with ankylosing spondylitis who have had an inadequate response to previous tumor necrosis factor (tnf) antagonist therapy

Conditions: Spondylitis, Ankylosing

Summary: this randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (roactemra/actemra) in patients with ankylosing spondylitis (as) who had an inadequate response to previous tumor necrosis factor (tnf) antagonist therapy. patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. the double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until week 104 for all patients. this study and all further clinical development of tocilizumab as was halted after a review of 12-week data from study na22823, a randomized double-blind, placebo-controlled study in tnf antagonist naïve as patients, failed to demonstrate efficacy.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age. * ankylosing spondylitis as defined by the modified new york criteria for ≥ 3 months prior to baseline. * active disease at screening and baseline (bath ankylosing spondylitis disease activity index \[basdai\] ≥ 4.0, spinal pain visual analog scale \[vas\] ≥ 40). * inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (nsaids). * inadequate response to treatment with etanercept, infliximab, adalimumab, or golimumab because of inadequate efficacy. * tumor necrosis factor (tnf) antagonist therapy must have been discontinued at least 8 weeks prior to baseline (etanercept 4 weeks). * traditional disease-modifying anti-rheumatic drugs (dmards) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline). * oral corticosteroids (≥ 10 mg/day prednisone or equivalent) and nsaids/cyclooxygenase-2 \[cox-2\] inhibitors must be at stable dose for at least 4 weeks prior to baseline. exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization. * total ankylosis of spine (as determined by investigator). * inflammatory rheumatic disease other than ankylosing spondylitis. * active, acute uveitis at baseline. * previous treatment with tocilizumab. * intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening. * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. * active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infection. * history of or currently active primary or secondary immunodeficiency. * body weight \> 150 kg.
correlation between intestinal parasites and serum level of eosinophils and ige in individuals with hiv or aids

Conditions: HIV Infections

Summary: correlation between intestinal parasites and serum level of eosinophils and ige in individuals with hiv or aids attended at clinical hospital of the botucatu medical school-unesp

the present study correlates intestinal parasitism and levels of eosonophils and of serum iges in patients attended at the c.h. of the school of medicine - botucatu/unesp. thirty adult patients with aids were analyzed in the use of haart, aged 42 ±11 years, 14 (46.7%) male, excluding those that had used anthelminthics 30 days prior to collection. socioeconomic questionaires were applied and 3 samples of feces were taken for parasitological exams (tf-test® method) and 5 ml of blood for counting eosinophils (automated hematological counter, pentra 80, abx) and ige doses (equipment bn-100, dade-behring). the index of parasites was 10%, with e.nana (3.3%), e.coli (3.3%) and b.hominis (3.3%). parasitized individuals were from an urban region with complete basic sanitation and good socioeconomic level. normal eosinphil values were found in all samples and increased ige values in 1 (33.3%) sample. the index of parasites was low due to good socioeconomic level and disease control. augmented ige levels corroborate the literature, which reports an increase characteristic of immune response in the face of parasitic infections in individuals with hiv or aids. in conclusion, new studies should be undertaken to evaluate the level of eosinophils associated with cytokines to obtain a better understanding of this correlation.

Eligibility criteria:
inclusion criteria: * hiv or aids * age same or superior to 18 years, * both sexes * assisted by the hospital of the clinics of botucatu medical school-unesp exclusion criteria: * use of anthelminthic in the period of 30 days antecedents the it dates from collection * individuals that don't have all of the necessary evaluations to the objectives of the study * individuals that abandon the attendance, or that you/they are to death during the study

Keywords: hiv aids intestinal parasites eosinophils immunoglobulins hiv/aids treatment experienced
eus based prevalence of chronic pancreatitis in alcoholic cirrhosis

Conditions: Alcoholic Cirrhosis

Summary: alcohol is the common precipitating factor for both cirrhosis of liver as well as alcohol related chronic pancreatitis. however, in real life clinical setting, clinicians do not frequently see many cases of symptomatic pancreatitis in patients who present with features of cirrhosis of liver. on the contrary, in some patients presenting with alcohol related chronic pancreatitis, evidence of cirrhosis of liver is observed on imaging without other clinical features of cirrhosis.

the data on exact incidence of chronic pancreatitis in patients with alcoholic cirrhosis is scarce and there are no data to support or refute as to whether the incidence is same between alcoholic cirrhosis or cirrhosis due to any other cause. the co-existence of cirrhosis and chronic pancreatitis in alcoholics vary between 0.04 - 6%. however, till now no study has been conducted to evaluate the incidence of cp in patients with alcoholic cirrhosis of liver. in this study, the investigators propose to assess the incidence of chronic pancreatitis in patients of ethanol related cirrhosis of liver and compare the same with patients of cryptogenic liver cirrhosis and hepatitis b and c related liver cirrhosis. this would be one of the few studies till date, to use eus as the diagnostic modality. the patients of cirrhosis would be categorized based on their child pugh criteria into three categories. all these patients would undergo eus at the institute and chronic pancreatitis screening would be considered positive if they fulfill the rosemont criteria for chronic pancreatitis.

Eligibility criteria:
inclusion criteria: • patients with diagnosis of ethanol related cirrhosis of liver who complains of central abdominal pain without any other identifiable cause of pain would be enrolled in the study. exclusion criteria: * any patients with evidence of hepatocellular carcinoma , autoimmune hepatitis related cld, and pbc would be excluded. * patients any co-existent other malignancy, sepsis, pregnancy. * an informed consent would be signed by the patient and any patient not willing to be a part of the study will be excluded.
the jules bordet institute molecular profiling program feasibility trial

Conditions: Colorectal Cancer Metastatic; Metastatic Melanoma; Metastatic Non-Small Cell Lung Carcinoma

Summary: prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the jules bordet institute (jbi) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. biopsie from metastatic lesions will be performed. a targeted cancer gene screen assay will be performed using dna sequencing. results will be discussed during a molecular screening tumor board.


Eligibility criteria:
inclusion criteria: * written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study. * age ≥ 18 years. * histologically proven metastatic or locally recurrent crc, nsclc or melanoma. * tumor tissue (ffpe and frozen) from recurrent or metastatic lesions available for research purposes. exclusion criteria: * eastern cooperative oncology group (ecog) performance status \>2. * the biopsy procedure is estimated to be too risky for the patient. * any anti-vegf or anti-vegfr treatment administered less than 3 weeks before new biopsy procedure. * no appropriate washout period for patients on anticoagulation therapy.