Kornimate/medical-research-clean huggingface dataset:
phase iii randomized, double-blind, placebo-controlled study of acellular and whole-cell pertussis vaccines

Conditions: Pertussis

Summary: objectives: i. compare the safety and efficacy of acellular 2-component vs. acellular multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in sweden. ii. compare the relative protection of each vaccine against atypical or subclinical pertussis infection. iii. analyze possible laboratory correlates to vaccine protection.

protocol outline: this is a randomized, double-blind study. patients are stratified by participating institution. the first group of infants receives a vaccine composed of inactivated pertussis toxin (ipt) and filamentous hemagglutin (fha). the second group receives a vaccine containing ipt, fha, pertactin, agglutinogen 2, and agglutinogen 3. the third group receives a whole-cell pertussis vaccine. the fourth group receives a diphtheria-tetanus vaccine as the control. all vaccines are given as an intramuscular injection, at 2-3, 4, and 6 months of age. close surveillance of infants and families continues for 2-3 years.

Eligibility criteria:
protocol entry criteria: --population characteristics-- * infants aged 2 months at planned date of first vaccination * no prior pertussis confirmed by culture * the following do not exclude: down syndrome prematurity healthy babies vaccinated according to chronological age recent pertussis exposure seizures in parent or sibling sudden infant death in sibling close relative with history of anaphylaxis or allergy close relative with history of strong reaction to vaccination --patient characteristics-- * age: under 3 months * renal: no renal failure * other: no prior gammaglobulin no requirement for immunosuppressives, e.g., hiv infection no manifest immunosuppression no serious chronic illness associated with failure to thrive no cardiac disease no progressive neurologic disease no uncontrolled epilepsy or infantile spasms no parental language or communication barrier

Keywords: bacterial infection immunologic disorders and infectious disorders pertussis rare disease
effect of dysport injections on energy expenditure and walking efficiency in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study aims to evaluate the efficacy of single event multi level chemoneurolysis with the abobotulinumtoxin a drug, dysport®, on walking energy expenditure and gait in children with spastic diplegia cerebral palsy.

cerebral palsy (cp) is the leading cause of disability in children, with the most widespread type of cp being spastic cp which negatively affects physical function. specifically it is reported that there is an increase in energy expenditure and oxygen consumption in children with cp. single event multi level chemoneurolysis with abobotulinumtoxina has been found to be an effective treatment for patients with spasticity to reduce energy expenditure by increasing walking efficiency; however many of these studies have conflicting methodological approaches. therefore this study aims to evaluate the single event multilevel chemoneurolysis with dysport® on energy expenditure and gait in children with spastic diplegia cp.

Eligibility criteria:
inclusion criteria: * age: 5-17 years. must be \<18 prior to injection. * \>10 kilograms at screening and injection visits * diagnosis of spastic diplegia or mild- to moderate spastic quadriplegia cerebral palsy * gross motor function classification system level: i, ii, iii * ability to ambulate independently without aid, equinus gait * absent of joint or bone deformities * eligible to receive single-event multi-level chemoneurolysis (semlc) * cooperative and tolerant to testing procedures during clinic screening * presence of spasticity in one or both legs * be on a stable dose and regimen if on any prescribed medication/s * parent must have signed written informed consent and the patient authorization for use and release of health and research study information exclusion criteria: * ankle contractures no more than -10 degrees with the knee extended * hemiplegia * wheelchair dependent * received botulinum toxin within previous 4 months * uncontrolled epilepsy or certain types of seizures * fracture in the study limb within previous 12 months * infection or skin disorder at planned injection site * shortness of breath or other respiratory issues * uncontrolled clinically significant medical condition * received phenol or alcohol block in the study limb within previous 6 months * surgery in the study limb within previous 12 months * serial casting within previous 12 months * new physiotherapy and/or orthotic regimen \ 1 month before study start and maintained throughout study)

Keywords: botulinum toxin a walking efficiency spasticity dysport pediatric
efficacy, safety, tolerability of neramexane in patients with subjective tinnitus

Conditions: Subjective Tinnitus

Summary: the purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.


Eligibility criteria:
main inclusion criteria: * patients aged between 18 and 75 years with a clinical diagnosis of first onset, persistent (i.e., tinnitus should never be absent for \> 24 hours in a row), subjective, uni- or bilateral subacute tinnitus main exclusion criteria: * clinical diagnosis of intermittent or pulsatile tinnitus * patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, menière's disease, otosclerosis, etc)

Keywords: subjective, tinnitus
liquid biopsy in lung cancer

Conditions: Lung Cancer (Diagnosis); Circulating Tumor Cell

Summary: the purpose of this study is to assess clinical utility of combined circulating tumor cell (ctc) and circulating tumor dna (ctdna) in the diagnosis of primary lung cancer.

the peripheral blood and tumor tissue samples are collected from the participants.ctc and ctdna are analyzed from the blood samples.

Eligibility criteria:
inclusion criteria: * patients with histology-proven lung cancer or a clinical suspicion of lung cancer * age \>=18, \< 80 years * no previous history of cancer treatment within 5 years * patients who agree to participate exclusion criteria: * patients who have been diagnosed with malignancy within 5 years * patients with previous history of lung cancer * patients who have uncontrolled coagulopathy

Keywords: lung cancer circulating tumor cell cell-free tumor dna liquid biopsy
trial of orbital atherectomy versus standard strategy in calcified bifurcation lesions

Conditions: Coronary Artery Disease; Coronary Disease

Summary: clinical research with medical devices indicated in accordance with the ce marking, led by researchers, multicenter, open, prospective, randomized and controlled. patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with orbital atherectomy (oa) and then a coronary stent. to evaluate the efficacy and safety of oa in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (oct).

the risk profile of patients and their comorbidities have worsened and the observed lesions undergoing treatment are increasingly complex. this has promoted the development of new technologies for plaque modification, especially in the context of calcified lesions. these predispose to suboptimal results of the intervention due to an increased risk of malapposition and underexpansion of the stents, the main variables for restenosis and/or thrombosis of the stents. thus, compared with non-calcified lesions, the increased amount of calcium in the coronary artery leads to a higher incidence of major adverse cardiac events (mace). coronary bifurcation stenting remains complex and is associated with a high risk of stent thrombosis and restenosis even with contemporary techniques, and suboptimal outcomes are frequently observed due to side branch (sl) involvement that increases cardiovascular events. our hypothesis is that the use of orbital atherectomy (oa) for coronary revascularization in the presence of calcified bifurcation lesions is feasible and safe compared to the more common technique, favoring the subsequent performance of provisional stenting (ps).

Eligibility criteria:
inclusion criteria: * patients over 18 years of age and * patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for pci with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and * patients agree to participate in the study, by signing the informed consent. exclusion criteria: * patients with revascularization of the artery to be treated within 9 months prior to the index procedure. * patients with contraindication for the use of orbital atherectomy: * patients in cardiogenic shock. * patients with thrombotic lesions. * patients with vascular graft disease. * patients with remain vessel disease. * patients with severe left ventricular dysfunction. * patients allergic to the components of the washing serum (glide). * patients with life expectancy less than one year.

Keywords: orbital atherectomy (oa) percutaneous coronary intervention bifurcation side branch treatment: mid-term results
non-invasive prediction of esophageal varices in liver cirrhosis: a multicenter observational study

Conditions: Liver Cirrhosis; Esophageal and Gastric Varices

Summary: esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. in the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding.

esophageal variceal bleeding is one of the most lethal complications of liver cirrhosis. in the early stage of liver cirrhosis, the prediction of esophageal varices is very important for guiding the clinical decision making of primary prophylaxis of variceal bleeding. the investigators' recent systematic review evaluated the diagnostic accuracy of apri, aar, fib-4, fi, king, lok, forns, and fibroindex scores in predicting the presence of esophageal varices in liver cirrhosis. however, their diagnostic accuracy was low to moderate. further study is warranted to establish a reliable score to predict the presence of high-risk esophageal varice in liver cirrhosis.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of liver cirrhosis. 2. age and sex are not limited. 3. etiology of liver cirrhosis is not limited. 4. routine laboratory data. 5. upper gastrointestinal endoscopy. exclusion criteria: 1. non-cirrhotic portal hypertension. 2. malignancy. 3. absent laboratory data. 4. a previous diagnosis of esophageal varices. 5. a previous history of variceal bleeding.

Keywords: liver cirrhosis esophageal and gastric varices endoscopy
a pilot study on the feasibility study of a novel virtual reality (vr)-based post-stroke hemineglect evaluation system

Conditions: Stroke, Complication

Summary: the normal value of the new virtual reality (vr)-based hemineglect evaluation system is obtained and its validity is checked by whether there is a difference in the evaluation results between normal people, stroke patients with hemineglect, and stroke patients without hemineglect. and, the usability of the virtual reality-based hemineglect evaluation system is confirmed.

this pilot study included 50 stroke patients with right hemisphere lesion and 25 healthy people. the normal value for each item is determined based on the result value for each item of the virtual reality (vr)-based hemineglect evaluation system in normal people. it is checked whether there is a difference in the results measured using the vr-based hemineglect evaluation system in normal persons, stroke patients with hemineglect, and stroke patients without hemineglect. structural validity is confirmed by examining the correlation between the measured values of the virtual vr-based hemineglect evaluation system and korean version of modified barthel index (k-mbi), mini mental state examination (mmse), and behavioral inattention test-conventional (bit-c) in stroke patients with hemineglect. check the required time and test stability of the evaluation using the vr-based hemineglect evaluation system.

Eligibility criteria:
inclusion criteria: (stroke patients) * right handed * patients with first onset stroke, with right brain lesions confirmed by imaging tests (mri, ct) * onset of stroke more than 1week (normal people) * right handed * who has no problem in identifying objects with wearing vr head gear. exclusion criteria: (stroke patients) * patients with unilateral neglect due to other causes. * patients with neurological diseases other than stroke (parkinson's disease, alzheimer's disease, etc.) * patients with severe cognitive impairment. * patients with underlying diseases or medical history that may cause visual impairment. (normal people) * who has a neurological disease such as stroke, traumatic brain injury, parkinson's disease, or alzheimer's disease. * who has a severe cognitive impairment. * who has a underlying diseases or medical history that may cause visual impairment.
ibd neoplasia surveillance rct

Conditions: Colonic Neoplasms; Inflammatory Bowel Diseases; Dysplasia

Summary: we will conduct a multicenter, parallel-group, non-inferiority rct in persons with ibd undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. the primary outcome is the neoplasia detection rate. the required sample size to demonstrate non-inferiority is 1952 persons.


Eligibility criteria:
inclusion criteria: * each potential participant must satisfy all of the following criteria to be enrolled in the study. * ≥ 18 years old * historical endoscopic/histologic disease extending beyond the rectum in uc or involving ≥ 1/3 of colorectum in cd\> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in uc, ≥1/3 colorectum in cd) * cibd ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis) * in symptomatic remission at time of colonoscopy * for cd: harvey-bradshaw index \< 541 * for uc or ibdu: partial mayo score ≤ 242 * major purpose of colonoscopy is neoplasia screening/surveillance * undergoing colonoscopy with high-definition white light endoscopy exclusion criteria: * persons who are unable to provide informed consent * persons with a history of colorectal cancer * persons with prior subtotal or total colectomy (\>50% of colon removed) * persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year * persons undergoing pancolonic chromoendoscopy or pancolonic virtual chromoendoscopy * colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (boston bowel preparation score of 0 or 1 in any segment) * incomplete colonoscopy (unable to reach cecum or terminal ileum \[if no cecum\]) * moderate-to-severe inflammation (mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (mayo 1) involving ≥ 50% of colorectum

Keywords: inflammatory bowel disease dysplasia biopsy colonoscopy
use of a heating cable to obtain hyperthermia during intraperitoneal chemotherapy

Conditions: Intraperitoneal Chemotherapy

Summary: the investigator will study the possibility of in situ heating of the liquid containing the chemotherapy, so as to avoid the need for an external pumping system with its complexity, and its associated risks and costs. the use of a heating cable (prototype hereinafter called thermowire, made by the company efs, which is in charge of its development) was patented and tested in pigs in two studies that included 15 animals altogether (in 7 of which the heating cable was used). the aim of the first study was the purely safety aspects, while the efficacy to obtain hyperthermia, the quality and the homogeneity of the hyperthermia and its effect on the tissue penetration of the chemotherapy were evaluated in a second study. the results obtained justify transfer to use in humans in the context of a clinical trial so as to obtain ce certification.


Eligibility criteria:
inclusion criteria: * patients with national health insurance cover * with scheduled hyperthermic intraperitoneal chemotherapy (hipec) because of known peritoneal disease (primary or secondary) * who have provided written consent exclusion criteria: * persons under guardianship * persons under 18 years old * pregnant or breast-feeding women * allergy to latex * abandon of hipec following surgical exploration
non invasive ventilation in bronchiolitis

Conditions: Non Invasive Ventilation

Summary: it is decided to perform a prospective study in a non-selected population of infants with bronchiolitis during one year ( october.2018 to october.2019) to study the characteristics, clinical course and outcome of the use of non invasive ventilation in the management and compare the results with those treated with invasive ventilation to assess safety and efficacy and inform guideline construction.

acute viral bronchiolitis is one of the most common respiratory diseases in early childhood and is a major health problem worldwide. the seasonal burden of the disease, the number of hospitalizations each year and the risk of subsequent asthma bring about substantial costs in developed countries. respiratory syncytial virus and human rhinovirus seem to be the most frequent etiologic agents, but other viruses such as human metapneumovirus, influenza virus, and parainfluenza virus can also be involved. the spectrum of clinical outcomes is wide, but bronchiolitis is more severe when caused by respiratory syncytial virus. in contrast, while human rhinovirus is involved in milder forms, it is more likely to be associated with recurrent wheezing in infancy. acute respiratory failure from pneumonia, influenza, and respiratory syncytial virus is responsible for 4.25 million deaths world-wide and the leading cause of mortality in low and middle-income countries. in the united kingdom up to 7% of bronchiolitis admissions require intensive care for ventilatory support. one third of unplanned infant admissions to pediatric intensive care units have respiratory failure, the majority due to bronchiolitis, require invasive mechanical ventilation for 4-7 days and a prolonged hospital stay. in countries where there is no retrieval infrastructure, the need to develop safe and effective alternatives to invasive ventilation and pediatric intensive care unit admission is acute. however, none of the interventions commonly used for infants admitted with bronchiolitis is backed by robust evidence of benefit for clinically significant outcomes, making this a pressing subject for further study. typically, intensive respiratory support for bronchiolitis is via invasive mechanical ventilation through an artificial airway, an intervention with recognized complications in infants. there is evidence to support the use of non-invasive ventilation in pediatric acute respiratory failure of variable causes.although evidence for use in bronchiolitis is increasing,clinical acceptance is not universal and published best practice guidelines are not easily available.

Eligibility criteria:
inclusion criteria: * all infants with acute severe bronchiolitis, * infants aged below 1 year. exclusion criteria: * patients who have contraindications for niv (patients with maxillofacial trauma, gastrointestinal obstruction and severe secretion), * children who had suspected or confirmed underlying chronic diseases (i.e., cystic fibrosis, chronic pulmonary disease, congenital heart disease, bronchopulmonary disease, prematurity, * children who had already more than one wheezing episode.
topical pancreatic duct lidocaine for prevention of post-ercp pancreatitis

Conditions: Pancreatitis

Summary: the purpose of this study is to determine if lidocaine is effective in reducing the incidence of post-ercp pancreatitis.

post endoscopic retrograde cholangiopancreatography (ercp) pancreatitis is a common cause of morbidity for which there is no known pharmacologic prophylaxis. post-ercp pancreatitis is thought to be caused by several factors, including intraductal pressure, multiple duct injections with contrast, and neural arc reflexes. lidocaine is a safe, inexpensive class iv antiarrhythmic that has topical anesthetic effects, inhibits trypsin activity, and may potentially prevent post-ercp pancreatitis by injection directly into the pancreatic duct at the time of ercp. lidocaine has been shown to inhibit phospholipase a2, a key pancreatic enzyme, interrupt local arc reflexes to stop neuronal transmission, and to dampen gi tract mucosal reflexes to prevent high ductal pressure. the key objective of this study is to determine if injection of lidocaine is beneficial in preventing post-ercp pancreatitis. subjects will be randomized to study group or control group in an equal ratio. the physicians performing the ercp will be unaware of the treatment group to which patients have been assigned. study arm will receive contrast agent diatrizoate 60% (5 ml) diluted with lidocaine 2% (5 ml) during ercp. control arm will receive contrast agent diatrizoate 60% (5 ml) diluted with normal saline 0.9% (5 ml) during ercp. diatrizoate diluted with normal saline is the standard of care. patients will be contacted 1 day and 1 week post-ercp to assess for symptoms of pancreatitis.

Eligibility criteria:
inclusion criteria: * patients included are \>18 years old, referred to endoscopy clinic for an ercp for any well established indication such as: biliary strictures, benign and malignant hepato-pancreato-biliary tumors, chronic pancreatitis, and suspected sphincter of oddi dysfunction exclusion criteria: * known sensitivity to lidocaine or contrast agent * history of seizure disorder * history of cardiac arrhythmia (tachyarrhythmia, bradyarrhythmia, cardiac conduction defects, prolonged qt syndrome) * history of congestive heart failure * active acute pancreatitis before procedure * planned biliary stent removal without pancreatogram * pregnancy * incarcerated individuals * less than 18 years of age * previous sphincterotomy * inability to give informed consent

Keywords: endoscopic retrograde cholangiopancreatography ercp pancreatitis lidocaine post-ercp pancreatitis