Kornimate/medical-research-clean huggingface dataset:
an observational study, called regoflex eu, to learn more about the use of stivarga at reduced doses as recommended (flexible dosing) to treat people with metastatic colorectal cancer in real world settings in europe

Conditions: Metastatic Colorectal Cancer

Summary: this is an observational study in which data from patients with metastatic colorectal cancer in three european countries who received stivarga® (regorafenib), are collected. in observational studies, only observations are made without specified advice or interventions. metastatic colorectal cancer (mcrc) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. a wide range of such enzymes called tyrosine kinases are targeted. in 2013, regorafenib was approved in europe for doctors to prescribe to people with mcrc who have previously been treated or cannot receive other available treatments. it is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. however, little information is available on the doses of regorafenib given in france, italy, and belgium in usual practice. in this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mcrc in france, italy, and belgium: * at the beginning * during, and * at the end of the regorafenib therapy. in addition, the study team will collect data about/if: * the treatment duration at each treatment dose of regorafenib, * the number of people who received reduced initial dosing of regorafenib in real word settings in france, italy, and belgium, * reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment. to answer these questions, the researchers will look back at cases that have already happened when the study begins. the data will be collected through an online case report form. the doctors will provide case histories of mcrc patients who started regorafenib treatment in most recent 3 years and 4 months (from january 1, 2019 to apr 30, 2022) or up until 3 months prior to the date of data collection. besides this data collection, no further tests or examinations are planned in this study. there are no required visits or tests in this study.


Eligibility criteria:
inclusion criteria: * patients with a histopathological or cytological diagnosis of colorectal cancer and metastatic disease (stages iva, ivb, or ivc) * patients must have initiated regorafenib as monotherapy, regardless of line of therapy, from january 1, 2019 to december 31, 2021 (or up until 3 months prior to date of data collection, whichever occurs latest) * aged ≥18 years at index date exclusion criteria: * patients with regorafenib treatment prior to january 1, 2019 * patients who have participated in a clinical trial
efficacy of choleretics in acalculous gallbladder in situ after endoscopic removal of biliary stones

Conditions: Common Bile Duct Stones; Gallbladder in Situ; Choleretics; Biliary Complications

Summary: in patients with gallbladder in situ after complete removal of common bile duct (cbd) stones, there is no definite guideline for the management of remnant acalculous gallbladder. this study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. so that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of cbd stones. second, the protective or preventive effect of choleretics may be defined.


Eligibility criteria:
inclusion criteria: * complete clearance of cbd stones * no definite gb stones * agree with the study protocol exclusion criteria: * \< 18 years of age * concomitant ihd stones * combined malignancy with a limted life span * prior cholecystectomy state * refusal to agree to the study protocol

Keywords: common bile duct stone gallbladder in situ choleretics
extraction of impacted 3rd molars, can bone support of the second molar be promoted by a bio-oss graft?

Conditions: Impacted Third Molar Tooth

Summary: a prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.

40 patients will undergo bilateral 3rd molar extractions, in each patient one side would be augmented by a "bio-oss" xenograft. post operative, periodontal parameters such as pocket depth and mobility will be evaluated and compared.

Eligibility criteria:
inclusion criteria: * bilateral impacted 3rd molars. * healthy individuals exclusion criteria: * smokers * alcohol abusers * pregnancy
chronotherapy for radiotherapy of glioma

Conditions: To Determine Whether the Timing of Radiotherapy Has an Effect on Patient Outcomes

Summary: this study aims to determine if there is any difference in the efficacy of radiotherapy for glioma outcomes in the morning or in the evening. the study team believes that there may be a benefit to taking the radiotherapy at a certain time of day. to test this theory the study asks participants who are already taking radiotherapy for glioma consistently at either the morning or in the evening based on when they currently take their radiotherapy. there will be this study visits where the participant will be asked to fill in questionnaires related to their neurological symptoms, their sleep habits, sleep quality, survival situation, and general health information followed by a blood draw.

the objective of this study is to determine whether the timing of radiotherapy to treat glioma has an effect on patient outcomes. primary objective: determine whether there is a difference in outcomes seen when patients are assigned to take their radiotherapy at either a morning time or evening time. the investigator hypothesize that administration time of radiotherapy during the day can affect the clinical outcomes in glioma patients. specific aims include: * determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients. * determine whether morning vs. evening dosing radiotherapy could affect the kps score of glioma patients. * determine whether morning vs. evening dosing radiotherapy could affect the cognitive function of glioma patients.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. pathological or cytological diagnosis of glioma; 3. normal liver and kidney function. exclusion criteria: 1. pregnant or lactating women; 2. second primary malignancy; 3. severe lung infection; 4. with high blood pressure although treated with medication; 5. patients with myocardial ischemia or myocardial infarction, arrhythmia (including qt interval \> 440 ms) or grade ii cardiac insufficiency; 6. arteriovenous thrombosis in 6 months prior to first administration, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 7. serious heart, lung and bone marrow impairment; 8. history of severe hypertension or cerebral hemorrhage

Keywords: radiotherapy, glioma, outcomes
scaling telehealth models to improve co-morbid diabetes and hypertension in immigrant populations (phase ii)

Conditions: Diabetes Mellitus Type II; Hypertension

Summary: the purpose of this study is to test the effectiveness and implementation process of a culturally and contextually tailored telehealth-based community health workers (chw) led coaching intervention for hypertension control among south asian patients with co-morbid diabetes mellitus type ii (dmii) and hypertension. the primary aims are to test the effectiveness of a chw-led telehealth intervention compared to usual care, and using reach, effectiveness, adoption, implementation, and maintenance (re-aim) and consolidated framework for implementation research (cfir), examine the reach, adoption, fidelity, and maintenance of the intervention within clinical and community settings.


Eligibility criteria:
inclusion criteria: * identified as of south asian ethnicity * at least 21 years of age * a diagnosis of diabetes * a diagnosis of hypertension * an uncontrolled bp reading (\>130/80mmhg) in the last 6 months exclusion criteria: * under the age of 21 * women who are pregnant * type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced) * inability to perform unsupervised physical activity
over-the-counter medications & covid-19

Conditions: SARS-CoV-2 Infection; Covid19

Summary: ibuprofen is one of several common medications implicated in coronavirus disease 2019 (covid-19) severity. on march 11, the lancet respiratory medicine published a letter stating ibuprofen can increase angiotensin-converting enzyme 2 (ace2) expression. on march 14, the french minister of health tweeted that ibuprofen should be avoided because it will aggravate covid-19. this concern was echoed by scientists and senior doctors in the british medical journal news on march 17. in response, the world health organization (who) issued a recommendation on march 18 to avoid ibuprofen in people with symptoms of covid-19. however, the who reversed this recommendation the next day because of insufficient evidence. health canada issued a safety alert on march 20 stating there was no evidence that ibuprofen worsens covid-19 symptoms. there is some evidence suggesting nsaid use (primarily ibuprofen) can increase severity of community acquired bacterial pneumonia in hospitalized children and adults. however, we do not know if ibuprofen use alters the course of covid-19. ibuprofen is an effective analgesic and antipyretic medication. people often use over-the-counter cough and cold products containing ibuprofen to manage symptoms of a respiratory tract infection before they seek medical attention. therefore, exposure to ibuprofen is highly probable in people with covid-19 symptoms. patients, clinicians, and policy makers need to know if ibuprofen is safe to use in management of covid-19 symptoms. this case-control study will explore the association between common medications and covid-19 severity in a cohort of people tested for sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: * residents of the province of alberta tested for covid-19 since march 1, 2020 exclusion criteria: * individuals who are currently hospitalized, who died, or who do not have contact information in the covid-19 test record

Keywords: ibuprofen over-the-counter medications
value of ultrasonographic enthesitis assessment in spondyloarthritis

Conditions: Spondyloarthritis; Enthesitis

Summary: the aim of the study is to determine how valuable ultrasonographic enthesitis to asssess disease activity, functionality and quality of life.


Eligibility criteria:
inclusion criteria: * spondyloarthritis patients that fulfill 2009 asas criteria exclusion criteria: * history of elbow, ankle or knee surgery, local injection at the examination sites within the six weeks, peripheral neuropathy, infection and wound at examination site
pass to assess cardiovascular and cerebrovascular events in copd patients initiating fixed triple therapy (dpi or pmdi)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this post authorisation safety study (pass) is to assess the incidence of adverse cardiovascular and cerebrovascular events in copd patients who are new to inhaled fixed triple therapy (dual bronchodilator plus corticosteroid) administered via dry powder inhaler (dpi) compared to new users of pressurized metered dose inhaler (pmdi). data from clinical practice from different european data sources will be collected. the baseline hypothesis is that the dpi is not associated with different risks of the primary and secondary outcomes, compared with pmdi.

non-interventional, multi-country cohort study to assess the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (copd), exposed to inhaled fixed triple therapy bdp/ff/gb via dpi (drug of interest) or pmdi (comparator). the study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different european data sources in the following countries: united kingdom, germany, the netherlands, denmark, sweden, norway and finland. patients in the two exposure groups of this post authorisation safety study (pass) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. the pre-defined hypothesis is that the dpi is not associated with different risks of the primary and secondary outcomes, compared with pmdi.

Eligibility criteria:
inclusion criteria: * patients diagnosed with copd * 40 years or older * availability of baseline information for a minimum of 12 months before the index date * new users of single inhaler triple therapy bdp/ff/gb via dpi or pmdi exclusion criteria: * single or multi-inhaler triple therapy in the previous 90 days before the index date * prescription of bdp/ff/gp administered via pmdi or dpi or any other single inhaler triple therapy in addition to a study drug on the index date. * hospitalization due to cardiovascular causes in the previous 30 days before the index date.

Keywords: retrospective cardiovascular cerebrovascular triple therapy
hedonic perception and brain activity response to meal

Conditions: Dyspepsia

Summary: the purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional mri.

functional mri brain imaging will be performed in patients with functional dyspepsia and healthy controls in basal conditions and after a palatable test meal. during the study, the cognitive response and the hedonic dimension will be measured using 10 score scales.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 yrs 2. body mass index between 18-30 kg/m2 3. right-handed exclusion criteria: 1. subjects with clinical history of eating-disorders 2. subjects with clinical history of significant head-trauma 3. subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the investigator). 4. subjects with a known history of alcohol or drug abuse in the previous 6 months. 5. subjects using medications with sns effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin. 6. women that are pregnant or that are breast-feeding. 7. claustrophobia

Keywords: functional brain mri functional dyspepsia hedonic response
verification of pulse oximetry in neonatal population

Conditions: Respiratory Distress Syndrome

Summary: the purpose of this his post-market, observational study titled verification of pulse oximetry in the neonatal population is to gather data to further support the accuracy of nonin's pulse oximeters when used in the neonate population. neonates who are currently undergoing arterial blood gas (abg) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. nonin's purelight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. the sensor immediately begins obtaining spo2 and pulse rate measurements which are sent to the oximeter module for display on the electronic data collection system (edcs). at the time the prescribed abg is drawn, the edcs must have a marker captured to identify the end of the abg for spo2 comparison. the spo2 accuracy of pulse oximeter will be measured by comparing spo2 readings of the pulse oximeter to values of sao2 (opportunity samples) determined by a co-oximeter.


Eligibility criteria:
inclusion criteria: * gestational age: 25 weeks to full term * weight range: no minimum or maximum range * age: up to 1 month (30 days) * gender: both * abgs as part of their medical care, to be analyzed by co-oximeter * consent signed by at least one legal guardian exclusion criteria: * presence of any skin irritation or breakdown on the foot * foot impediments which would preclude proper placement of the sensor * clinical condition precluding the use of adhesive materials * cessation of abgs during study enrollment

Keywords: oximeter arterial blood gas comparison
dynamic full-field optical coherence tomography for structural and microbiological characterization of endotracheal tube biofilm in critically ill patients

Conditions: Healthcare Associated Infection; Critically Ill; Endotracheal Tube

Summary: biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. as early as the 2000s, the centers for disease control and prevention (cdc) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (vap) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs. targeting biofilm therefore now appears to be a new area of interest for limiting the risk of vap, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe . evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm. to this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, biopavir 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm. based on the previous description of biofilm by optical coherence tomography (oct), and a recent experience with an optimised form of high-resolution oct, called full-field oct, the investigator hypothesise that full-field oct will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm biopavir 2 proposes to use the performance of full-field oct to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. this project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of vap


Eligibility criteria:
inclusion criteria: * patient or relative informed of the study and having declared their nonobjection * patient over 18 years of age * patient exposed to mechanical ventilation for at least two calendar days exclusion criteria: * patient unable to declare their nonobjection * patient whose endotracheal tube collection is impossible * patient whose endotracheal tube is collected following self-extubation (sample contamination)
three protocols for phenylephrine administration in cesarean delivery

Conditions: Cesarean Section Complications; Spinal Anesthesia

Summary: the investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/kg/min) with fixed rate (0.75 mcg/kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/kg) phenylephrine.

maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (cd). phenylephrine (pe) is the most popular vasopressor for prevention of post-spinal hypotension (psh) during cd; however, the most appropriate protocol for pe administration is still unknown. the most common pe protocols used for prophylaxis against psh are: single shot, fixed infusion, and variable infusion. a recent study reported that a dose of 1.5 mcg/kg is the most suitable single-shot dose for prophylaxis. another randomized controlled trial compared four doses of pe infusion and reported that 25 mcg/kg/min and 50 mcg/kg/min doses were the best doses for fixed infusion with accepted incidence of both psh as well as reactive hypertension. using variable infusion rate of pe had been recently introduced in another study with a starting dose of 0.75 mcg/kg/min. the variable rate infusion showed very good results regarding psh. in this study, the investigators will compare variable infusion of pe (at a starting rate of 0.75 mcg/kg/min) with fixed rate (0.75 mcg/kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/kg).

Eligibility criteria:
inclusion criteria: * full term * pregnant women * scheduled for cesarean delivery exclusion criteria: * pre-eclampsia * eclampsia * hemorrhage * cardiac dysfunction * baseline low heart rate (below 60 bpm)
slow-release locally administered 0.02% hypochlorite formulation

Conditions: Periodontal Diseases

Summary: aim: the presence of bacterial plaque is associated with the development of periodontal inflammation. the aim of this single-blind randomized clinical study was to prospectively evaluate the efficacy of two different agents in a staged approach for nonsurgical periodontal treatment in terms of clinical and patients related outcomes in a cohort of patients with periodontitis: nitradine® based disinfectant formula (periotabs®) vs chlorhexidine 0.12 toothpaste and mouthwash 0.20. material and methods: patients with a diagnosis of periodontal disease (stage i-iii) scheduled for non surgical periodontal treatment were randomly allocated to the preparatory home use of a chlorhexidine mouthwash or a nitradine® based brushing solution called periotabs® for 10-15 days. active decontamination with ultrasonic scalers was performed after the completion of the preparation period. clinical and patient-related outcomes were recorded at baseline, at the moment of professional intervention, and after 30 and 90 days from baseline.


Eligibility criteria:
inclusion criteria: * older than 18 y.o, * systemically healthy, * with a clinical diagnosis of periodontitis exclusion criteria: * alcohol or drug abuse, * regular drug use of bisphosphonates, * non-steroidal or steroidal anti-inflammatory, * daily antacid therapy, * selective serotonin reuptake inhibitors and other therapy that might affect periodontal health, * antibiotics during the previous 6 months, * smoking more than ten cigarettes per day; * pregnancy; * lactation; * previous periodontitis treatment within the last 6 months, * radiotherapy to the head or neck, current chemotherapy.