Kornimate/medical-research-clean huggingface dataset:
12 month follow up in vivo icon study on fluorotic teeth

Conditions: Fluorosis; Oral Deseases

Summary: clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.

dental fluorosis is an endemic public health concern that develops if infants are subjected to excessive amounts of fluoride during enamel formation. anatomopathologically, dental fluorosis presents itself as a hypermineralized surface layer and subsurface hypomineralization involving the external third of the thickness of the enamel, which is equivalent to early carious lesions. in addition, fluorosis features a number of clinical changes in the enamel surface, ranging from the appearance of thin white lines up to severe structural defects, thereby compromising overall esthetics, which sometimes leads to children dropping out of school due to its psychological impact. the aim of this controlled clinical trial is to evaluate the efficacy of enamel microabrasion and resin infiltration in improving the dental esthetic of patients with fluorosis. resin infiltration is a microinvasive technique that can improve the esthetics by infiltrating a low-viscosity resin (that has a similar refractive index to enamel) into the porose hypomineralized enamel of fluorosed white spots. this approach thus largely preserves the enamel compared to more invasive techniques such as microabrasion and has been shown to be efficient in previous studies. this study will be conducted in the provinces of pichincha and cotopaxi, ecuador and patients between 10 to 12 years of age with stage 1, 2, and 3 fluorosis according to the thylstrup and fejerskov (tf) scale or questionable, very mild, and mild fluorosis according to dean's index will be recruited. in addition to the immediate esthetic improvement, long term stability of the outcome will be assessed at 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * questionable, very mild, and mild (dean's index) dental fluorosis as well as tf scale grades 1, 2, and 3 of the upper anterior teeth. * parents of children who accept and commit to the informed consent letter collaborate with the study taking their children to each of the scheduled follow ups. exclusion criteria: * teeth without fluorosis. * teeth with hypoplasia. * teeth with incipient caries lesions observed at gingival level and differentiated by the presence of plaque. * teeth previously restored or with aesthetic corrective treatments * teeth with endodontic treatment. * patients with low or questionable hygiene. * malnourished patients or that have some underlying disease. * teeth with less than two thirds of its visible crown. * children that have less than six teeth in their oral cavity. * allergic reaction to methylmethacrylate.

Keywords: enamel defects fluorosis icon resin infiltration
influence of the vitamin d blood levels on the amyotrophic lateral sclerosis phenotype

Conditions: Amyotrophic Lateral Sclerosis

Summary: the main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of vitamin d total. secondary objectives are to investigate the relationship between blood levels of vitamin d and total disease duration of als, forced vital capacity, weight loss, age of onset and the start site of als.

amyotrophic lateral sclerosis is one of the most serious neurodegenerative disease, leading to death in 3 years by progressive paralysis of 4 limbs, speech, swallowing and breathing, and due to a progressive death of central and peripheral neurons. the cause of the disease is unknown, but an immunologically factor is more precisely suspected in als. since 2008, the work of immunology have shown that vitamin d was a major regulator of immunity. it regulates particularly the function of dendritic cells and regulates the immune response in macrophages. a vitamin d deficiency will induce activation of microglia. in neurology, vitamin d deficiency is associated with a greater impairment in neuronal function. this deficit is associated with a faster alteration of the microvasculature, alteration known to increase neuronal suffering and to enhance the neurodegenerative processes. the investigators postulate that als patients have a more severe prognosis if their vitamin d levels at the time of diagnosis is lower. the main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of vitamin d total. secondary objectives are to investigate the relationship between blood levels of vitamin d and total disease duration of als, forced vital capacity, weight loss, age of onset and the start site of als.

Eligibility criteria:
inclusion criteria: * subject with possible, probable or definite amyotrophic lateral sclerosis (als). * als operating for less than three years at dosage of vitamin d time. * subject monitored in the center als of montpellier for 6 months. * subject agreeing to give his consent in writing or orally if the patient sla is unable to write exclusion criteria: * subject has received a vitamine d treatment in the six months preceding the inclusion * subject with a clinical condition on the inclusion day that makes it highly probable death in the year (quadriplegic patient, subject ventilated for respiratory failure in als, major malnutrition) or with alsfrs-r score \<20. * pregnant or breastfeeding women * subject not covered by a social security scheme. * subject under guardianship * adult protected by the law

Keywords: amyotrophic lateral sclerosis vitamin d blood levels
study of ventilator associated event during intensive care after resuscitated cardiac arrest.

Conditions: Cardiac Arrest With Successful Resuscitation; Mechanical Ventilation

Summary: the aim is to describe the incidence, characteristics, risk factors and outcome of complications acquired under mechanical ventilation (called ventilator-associated events) according to the new cdc criteria, in a population of patients admitted in intensive care unit after cardiac arrest.

cardiac arrest (ca) survivors are frequently admitted to intensive care units. despite improvements in management techniques, the prognosis of these patients remains poor, with mortality exceeding 90% for out-of-hospital ca and around 80% for in-hospital ca, along with a high risk of severe neurological issue. the management of these patients in intensive care requires the use of invasive mechanical ventilation. complications occurring under mechanical ventilation have been the subject of many researches. early bacterial pneumonia or ventilator-acquired pneumonia appears as the primary cause of respiratory worsening, and several studies have already focused on their incidence and prevention. however, studies on the benefits of antibiotic therapy or antibiotic prophylaxis for early pulmonary infections are of tricky analysis, particularly when they do not consider respiratory condition or mortality for their primary outcome measure. a new definition of complications associated with mechanical ventilation (vaes) has been established by the centers for disease control and prevention (cdc) since 2013. it offers a more relevant tool for monitoring the impact of preventive measures on morbidity and mortality, with a more objective definition that goes beyond just tracking ventilator-associated pneumonia. several studies have since analyzed the incidence and impact of vaes on cohorts of intensive care patients, confirming the association between vaes and morbidity and mortality. however, to our knowledge, none have targeted a population of cardiac arrest survivors.

Eligibility criteria:
inclusion criteria: * adult male or female * non-pregnant female * successfully resuscitated from cardiac arrest during primary care * invasive mechanical ventilation initiated during resuscitation and continued for at least 4 days * no decision to limit life-sustaining therapies within 24 hours following admission to intensive care * no requirement of arteriovenous circulatory support during intensive care management exclusion criteria - patients who opposed to the use of their data

Keywords: ventilator associated event cardiac arrest ventilator-acquired pneumonia ventilator associated pneumonia
inhaled beclomethasone after community-acquired respiratory viral infection in lung transplant recipients

Conditions: Lung Transplant Infection

Summary: the purpose of this study is to determine if the use of inhaled beclomethasone after a community-acquired respiratory viral infection in a lung transplant recipient decreases the risk of the subsequent development of chronic lung allograft dysfunction.

community-acquired respiratory viral (carv) infections after lung transplantation are associated with an increased risk for the development of chronic lung allograft dysfunction (clad) after lung transplantation. the exact mechanisms whereby carv infections increase this risk are unknown. we propose that viral infection results in airway epithelial cell injury and the expression of injury-response genes that provide signals that initiate immunologic and non-immunologic pathways that result in the airway remodeling characteristic of obliterative bronchiolitis, the predominant pathology of clad. systemic and inhaled corticosteroids are frequently used as anti-inflammatory agents to treat the peribronchiolar inflammation seen in viral bronchiolitis. beneficial effects from corticosteroids have been reported, but this has not been demonstrated in lung transplant recipients. the aim of this single center, randomized, double blind, placebo controlled study is to evaluate the short and long term effects of a 6 month course of inhaled beclomethasone on adult lung transplant recipients with carv infection.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years old) * single, bilateral, or heart-lung transplant recipient * confirmed infection with a community-acquired respiratory virus including: adenovirus, coronavirus, influenza a or b, respiratory syncytial virus (rsv), parainfluenza virus (piv), human metapneumovirus (hmpv), and rhinovirus * at least 6 months post-transplant, with completion of 6 month bronchoscopy if indicated * able and willing to give written informed consent and comply with study procedures (e.g. testing, treatment) exclusion criteria: * bos stage 3 * requirement for mechanical ventilation at study entry * use of inhaled steroids at the time of carv infection * any condition that in the investigator's opinion would preclude the patient's participation in a clinical trial * lack of available spirometric data to establish a baseline forced expiratory volume in 1 second and/or forced vital capacity * pregnancy * current participation in another interventional clinical trial

Keywords: chronic lung allograft dysfunction community-acquired respiratory viral infection
influence of obesity and gastric bypass on medication absorption

Conditions: Obesity

Summary: patients who have scheduled a gastric bypass (rygb) in uz leuven, will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. the purpose of this study is to explore current practice regarding the use of medication and medication counseling after rygb and to examine the changes in dietary pattern before and after rygb.

target group: patients who have scheduled a gastric bypass in uz leuven. patients will be questioned preoperatively and one, three, six and twelve months after gastric bypass surgery. each assessment will be performed during a routine consultation. the following aspects will be investigated: * medication the investigators have composed a questionnaire to examine which drugs the patients use, adherence, information received about medication and from whom,... * clinical parameters every consultation, concentrations of hemoglobin, iron, hepcidin, vitamin b12,.... and a 24h urine collection to determine calcium excretion will be collected. * dietary intake the investigators will ask patients to keep a food record during two non-consecutive days preceding each consultation. in this food record patients have to note all consumed foods and beverages with the right/estimated amounts. this makes it possible to see the changes of the composition of the meals before and after rygb. * body composition

Eligibility criteria:
inclusion criteria: * patients who have scheduled gastric bypass * use of at least one chronic drug (including contraception) exclusion criteria: * patients who have undergone another form of bariatric surgery before rygb

Keywords: obesity gastric bypass medication medication counseling dietary pattern follow-up of patients
an exploration of the impact of gene therapy on the lives of people with haemophilia and their families

Conditions: Hemophilia

Summary: this study programme aims to examine the real-world experience and impact of gene therapy in a diverse community of people and families affected by haemophilia who have been or will be exposed to gene therapy.

this is a prospective observational multiple cohort qualitative research study to be conducted among diverse groups within the haemophilia community whose lives may have been impacted by gene therapy. the study is designed to allow english-speaking patients and their families to tell their own life stories through narrative accounts. the narratives represent a true sharing of experiences and offer insight into how these patients and families cope with haemophilia.

Eligibility criteria:
inclusion criteria: * people with haemophilia a or b who consented to and have undergone gene therapy in the early dose-finding studies and a member of their family * people with haemophilia a or b who consented to a gene therapy trial following the results of the early studies and a member of their family * people with haemophilia a or b who consented to a gene therapy trial but who withdrew, were withdrawn from, or were ineligible for the study, and a member of their family * people with haemophilia a or b who are definitely not interested in or unaware of gene therapy and a member of their family * people with haemophilia a or b who are interested in but have not been offered gene therapy * those who have given written consent to be in the study * all participants will be ≥16 years. exclusion criteria: * participants will be excluded if they do not speak english (for the interviews) or do not consent to be in the study.

Keywords: haemophilia, gene therapy, quality of life
ameliorating attention problems in children with sickle cell disease (scd)

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to assess whether methylphenidate is effective in enhancing the cognitive performance of children with the hbss or hbsc genotype of scd who have sustained neurological complications on laboratory-based measures of sustained attention, reaction time, and executive functions, and indirectly, verbal short-term and long-term memory.

sickle cell disease (scd) is a group of autosomal recessive disorders, affecting an estimated 1 in 400 african american newborns annually. the pathophysiology of this group of disorders involves the production of abnormal hemoglobin (hbs), which causes red blood cells to assume a rigid, sickled shape upon release of oxygen, thereby reducing their viability in circulation. consequently, chronic anemia and system-wide ischemia result in acute painful episodes, organ system failure, and neurological complications. among the most debilitating effects of scd are neurological complications. despite the mounting evidence for structural and functional involvement of the frontal systems in pediatric scd, there have been no clinical trials designed to manage the cognitive and behavioral sequelae associated with pediatric scd.

Eligibility criteria:
inclusion criteria: * informed consent can be obtained from parent or care-giver and assent can be obtained from the child * children with sickle cell disease (hbss or hbsc) * age range from 6 to 16 years inclusive * english is the child's primary language * t-score greater than or equal to 63 on either the conners' parent rating scale - revised or the conners' teacher rating exclusion criteria: * history of glaucoma for which methylphenidate is contraindicated * child or immediate family member has a history of a tic disorder or tourette's syndrome * child is currently receiving antidepressant, anxiolytic, antipsychotic, or stimulant drug therapy * family history of substance abuse disorder due to potential for abuse of stimulants by caregivers or other family members * recent history of uncontrolled seizures (may be on anticonvulsants, provided seizures are under "reasonable" control and that the patient and family understand the risk of altered seizure control and potential interference with maintaining therapeutic levels of anticonvulsants) * hypothyroidism * symptoms of affective and mood disorders * previously diagnosed with adhd prior to the onset of neurological complications (e.g., stroke or silent infarct) as documented in the medical record or caregiver report. * mental retardation (fsiq \< 70 on wasi)
evaluation of endovenous sclerotherapy for treatment of varicose veins

Conditions: Varicose Veins

Summary: the overall objective will be to evaluate clinical predictors of outcomes in patients who undergo endovenous sclerotherapy for the treatment of varicose veins.

a prospective cohort study of patients who undergo endovenous sclerotherapy over 2 years. there are no deviations in usual clinical assessment and care of patients seeking varicose vein treatment. the purpose of this protocol is only to collect clinical and biomarker information related to this standard treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of varicose veins exclusion criteria: * none

Keywords: varicose veins superficial thrombophlebitis deep vein thrombosis ulceration leg pain leg swelling
good choice of palliative chemotherapy to patient with pancreatic cancer ; gemcitabine therapy vs folforinox therapy

Conditions: Locally Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer

Summary: the study objectives are to find out: 1) palliative chemotherapy patterns and prognosis in patients with locally advanced or metastatic pancreatic cancer in korea's real clinical settings, and 2) reasons adopted by clinicians in choosing therapeutic drugs.

this study is a domestic, multi-center, prospective, observational study designed for locally advanced or metastatic pancreatic cancer patients who plan to receive palliative chemotherapy. when patients voluntarily express their consent to provide their information to this study by signing a written agreement, their baseline information including demographics, comorbidities, pancreatic cancer-related information, medical treatment history, etc. shall be used for screening. when patients are judged eligible for study participation, they shall receive an appropriate palliative chemotherapy. after first-line chemotherapy (baseline), information review shall be conducted at month 2, 6 and 12 for chemotherapy currently in use (whether or not chemotherapy ended/discontinued and relevant reasons; type, frequency and duration of administered drugs), recist, quality of life (month 2 and 6), activity performance assessment, laboratory tests, tumor marker test, adverse drug reactions, etc. however, if first-line chemotherapy moves to second-line chemotherapy due to causes such as progressive disease (pd), information review shall be restricted to the relevant drug name and survival until the end of the study (month 12).

Eligibility criteria:
inclusion criteria: 1. patients are briefed about the study objectives and methodologies, and express their consent by signing a written agreement for the use of their personal information. 2. male and female adults who are ≥ 19 years old at the time of enrollment. 3. locally advanced or metastatic pancreatic cancer patients whose diagnosis was confirmed histologically or cytologically. 4. patients who plan to receive palliative chemotherapy (e.g., folfirinox, gemcitabine-based therapy, etc.) exclusion criteria: 1. patients who are diagnosed with any other primary cancer that may influence pancreatic cancer treatment or prognosis. 2. patients who are currently or have a history of receiving palliative chemotherapy. 3. female patients who are pregnant, have childbearing potential or are breastfeeding. 4. patients who are currently participating in other clinical trials (clinical trials for drugs or medical devices) or are planning to participate in other clinical trials during the study period. however, patients participating in a non-interventional observational study or registry study can be enrolled. 5. other patients who are judged by the investigator to be ineligible to participate in the study.

Keywords: pancreatic cancer palliative chemotherapy
opioid free anesthesia and continuous post-operative pulse oximetry monitoring in the obese patient

Conditions: Anesthesia

Summary: anaesthesia has three major components, analgesia, muscle relaxation and hypnosis. for a long time, opioids have been covering the analgesia function. (1) when using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. opioid usage is an important risk factor of postoperative desaturation. postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications. thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage. non-opiate protocols implemented on the obese patient have been published. non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist. the main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.

anaesthesia has three major components, analgesia, muscle relaxation and hypnosis. for a long time, opioids have been covering the analgesia function. when using opioids, an analgesic effect is obtained per-operatively, however, not without side-effects. post-operative complications such as: respiratory depression, post-operative nausea and vomiting, pruritus, acute opioid tolerance and hyperalgesia, difficulty voiding and ileus, are well known. these complications may lead to a prolonged hospital stay. opioid usage is an important risk factor of postoperative desaturation. postoperative desaturation can lead to severe hypoxemia and even tissue hypoxia, followed by obvious cardiologic and neurological complications. thus, in patients at risk, such as the obese patient, experts suggest reducing opioid usage. authors have indeed published non-opiate protocols implemented on the obese patient. non-opiate protocols have been established using a combination of ketamine, lidocaine and an alpha-2 agonist. the main purpose of this pilot study is to evaluate whether patients undergoing an opioid free anaesthesia regime experience less desaturation episodes during the first 24 h post-bariatric surgery than patients having received an opioid anaesthesia regime.

Eligibility criteria:
inclusion criteria: * all patients undergoing a gastric by-pass surgery will be screened. * patients with an asa physical status of i-ii-iii (bmi \>30) will be included. * knowledge of either french, english or dutch will be required in order to be enrolled in this study. exclusion criteria: * allergy or contraindications to one of the study drugs * renal failure * hepatic failure * hyperthyroidism * av block 2 or 3 * severe bradycardia * left ventricular failure * unstable blood pressure * severe respiratory disease * epilepsy * psychiatric disturbance.